regents of the university of california v. aisen (usc) - complaint

7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint

http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 1/87

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CROWELL

MORNG LLP

J. Daniel Sharp (SBN 131042)

dsharNi,

crowell.com

27 5 Battery Street, 23rd Floor

San Francisco, CA 94111

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15.986.2800

Facsimile:

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Mark A. Romeo (SBN 17 3007)

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Derek Hecht (SBN 273039)

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D

Clerk of

the Superior

Court

JUL

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Attorneys for Plaintiff

THE REGENTS OF THE U NIVERSITY OF CALIFORNIA

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SUPERIOR COURT OF THE STATE OF CALIFORNIA

COUNTY OF SAN DIEGO

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THE REGENTS OF THE UNIVERSITY

OF C ALIFORN IA, a California

Corporation,

Plaintiff,

V.

PAU L S. AISEN , an individual;

JEREMY PIZZOLA, an individual;

DEBORA H TOBLAS. an individual;

GUSTAVO JIMENEZ-MAG GIORA, an

individual; PHUO C H ON G, an individual;

HON G M EI QIU, an individual;

STEFANIA BRUSC HI, an individual; RA-

SING SO , an individual; MAYYA

NESSIRIO, an individual; U NIVERSITY

OF SOUTHERN CALIFORNIA, a

California Corporation; and DOES 1-25,

Inclusive,

Defendants.

Case No

37-2015-00022082-CU

BT

-

CTL

COMPLAINT FOR MONEY DAMAGES

AND EQUITABLE RELIEF FOR:

1.

BREACH OF FIDUCIARY DUTY;

2 .

BREACH OF DUTY OF LOYALTY BY

EMPLOYEE;

3.

INTERFERENCE WITH UirsITRACT;

4 .

INTERFERENCE WITH

PROSPECTIVE ECONOMI

ADVANTAGE;

5 .

CONVERSION;

6.

COMMISSION OF COMM I

CRIMES;

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CIVIL CONSPIRACY

DEMAND FOR JURY TRIAL

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C:wwELI

MoK;Nc; 1.1.P

ArTkNF)c AT LAS

SFACTIVE-90372830 1.1

COMPLAINT FOR MONEY DAMAGES AND EQC:TABLE RELIFF



Plaintiff The Re gents of the University of California alleges upon know ledge as to its own

actions, and upon information and belief as to all other m atters, against Defendants Paul S. A isen,

Jeremy Pizzola, Deborah Tobias, Gustavo Jimenez-Magg iora, Phuoc Hong, Hong M ei Qiu,

Stefania Bmschi, Jia-S ing So, and Mayya Nessirio and the University of Southern California as

follows:

THE PARTIES

1.

The Regents of the University of California ("The Regents" or "Plaintiff') is a

California corporation doing business in the County of San Diego, State of C alifornia.

2.

Defendants Paul S. Aisen ("Aisen"), Jeremy Pizzola, Deborah Tobias, Gustavo

Jimenez-Maggiora, Phuoc Hong, Hong Mel Qiu, Stefania Bruschi, Jia-Sing So, and Mayya

Nessirio (sometime s collectively referred to as "Individual Defendants") are and w ere at all

relevant times individuals residing in the C ounty of San Dieg o, State of California.

3.

Defendant U niversity of Southern California ("USC ") is a California corporation

doing business in the Counties of Los Ang eles and San Diego, State of C alifornia.

4.

Plaintiff is informed and b elieves and thereon alleges that each of the D efendants

fictitiously sued hereunder as Does 1 through 25 are in some manner responsible for the

occurrences alleged hereunder and the damag es which Plaintiff alleges hereunder, and that at all

times, each of said Does w ere acting as the agent for each other or the Defendants w ithin the

scope and capacity of said ag ency. Plaintiff is ignorant of the true nam es and capacities of such

Defendants sued herein as Does 1 through 25 inclusive and therefore sues these Defendants by

such fictitious names for the sam e acts and causes of action alleged against D efendants. Plaintiff

w ill seek leave of Court to am end this Com plaint to allege the true nam es and capacities of said

Defendants at such time as they may b e ascertained.

JURISDICTION AND VENUE

5.

The conduct alleged herein occurred w ithin the County of San Diego, State of

California, and jurisdiction and venue is proper w ithin this County.

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SFACTIVE-90372830 I. I

COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF



GENERAL ALLEGATIONS

The Regents and the ADCS

6.

The R egents is a California corporation authorized and empow ered to administer a

public trust known as the University of California ("UC" or "(he University"). Under Article IX,

section 9, of the California Constitution, the Regents is vested w ith full powers of organization

and governm ent over the University, including all powers necessary or convenient for the

effective administration of the public trust and the advancem ent of the tripartite mission of the

University: to provide excellence in teaching , research, and pub lic service.

7.

The Regents maintains a campus in this county known as the University of

California, San Diego ("UCSD"). UCSD operates a School of Medicine as well as the UC San

Diego H ealth System, w hich is the region's only academ ic health system and provides patient

care, conducts me dical research, and serves as a training ground for health care professionals.

8.

Since 1991, UCSD has managed a research enterprise known as the Alzheimer's

Disease Cooperative Study ("ADCS") under a cooperative agreement with the National Institute

on Aging ("NIA"), which is an agency of the federal government and one of the National

Institutes of Health ("NIH"). The ADCS facilitates the testing of new drugs for the treatment of

Alzheime r's disease, particularly drugs that mig ht not otherwise be tested b y private industry. To

this end, ADC S coordinates clinical trials and other research activities at approximately 7 0

academic medical centers and research clinics in the United States and Canada. The ADCS is in

he nature of a joint venture, but instead of operating for profit, it operates for the advancemen t of

the missions of the NIA and The Regents with respect to medical education, research, and public

service.

9.

The work of the ADCS is funded primarily by the federal government and private

companies pursuant to the terms of written contracts entered into by The Regents. These

contracts are sometim es colloquially referred to as "g rants," and typically carry titles such as

"Collaborative Study Agreement" and "Clinical Trial Research Collaboration Agreement." The

value of the grant funding is in exc ess of $100 m illion. This funding finances research activity as

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we ll as administrative costs, including the salaries of the approximately 80 em ployees and

2 administrators who run the ADCS at UCSD.

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CSD Entrusted Defendant Aisen with the Directorship of the ADCS

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rom the time that the ADCS was established in 1991 until February 2007, the

5 Director of the ADCS was Leon Thal, M.D., a Distinguished Professor and Chair of

6 Neurosciences at UCSD. Dr. Thal had joined the UCSD faculty in 1985 and over the years

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ecame the acknowledged leader in the development of drug therapies for Alzheimer disease. In

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ebruary 2 007 , he was tragically killed in a plane crash.

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ollowing the death of Dr. Thal, UCSD conducted a search for a new Director of

10 the ADC S and hired Defendant Paul Aisen, M.D. in November 2 007. D r. Aisen became

11 employed by The Regents as a Professor of Neurology and Medicine at UCSD and was appointed

12 Director of the ADCS. A s such, Defendant Aisen was the agent of T he Regents and its fiduciary

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n effectuating UCSD's participation in the ADCS venture. As an employee of The Regents,

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efendant Aisen ow ed a duty of loyalty to the U niversity during his tenure, including a duty to

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efrain from actions that are inimical to the interests of The R egents, and to avoid g iving

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reference to his own interests, or those of a rival employer, at the expense of The R egents and

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CSD . The position of Director of the AD CS is one of prestige and influence in the field of life

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ciences, and UCS D placed trust and confidence in Defendant Aisen to discharge his obligations

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o The Reg ents with honesty and candor.

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Defendant Aisen and Defendant IJSC Conspire to Misappropriate IJCSD's Role in

the ADCS

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ithin the past week, The R egents has learned that, beginning at least as of April

23 2015, Defendant Aisen and Defendant USC began to conspire with one another to displace UCSD

24 in the ADCS, to interfere with The Regents' contractual and economic relationships with ADCS

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inders, to interfere with the Regents' relationships with UCSD employees engaged in work on

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ehalf of the ADC S, and to usurp the beneficial opportunities available to The Regents through

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CSD's role in the ADCS. The Regents do not presently have access to all of the facts showing

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he extent of the conspiracy and the w rongful acts done in furtherance of their comm on design,

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and w ill require discovery to present such facts at trial. How ever, the facts set forth below have

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een learned within the past week.

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n April 2015, Defendant Aisen reached out to USC Provost Michael Quick to

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esume discussions, begun a t some earlier time, regarding the potential for Defendant Aisen to

5 join the faculty at USC, w hich operates the K eck School of Medicine ("K eck") near downtown

6 L os Angeles. K eck has an A lzheimer's Disease Research Center, also located near downtown

7 Los Angeles.

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or reasons known best to Defendants, the discussions between Defendants Aisen

9 and USC soon centered on making arrangem ents for Dr. Aisen to remain in the vicinity of La

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olla, where USC has no facilities of any kind. Defendants agreed to create a brand new

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Institute" in San Diego by hiring away the necessary UCSD employees who serve the ADCS,

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nd seeking to supplant UCSD as the contracting party in connection W ith research contracts and

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ther agreeme nts related to ADCS , including the lease for the office space that houses the

14 UCSD/ADCS staff. Defendants Aisen and USC thus planned to cripple UCSD's ability to

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erform its cooperative agreement with the NIA to administer the ADCS.

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efendant Aisen demanded, and Defendant USC agreed to provide, significant

17 incentives for Dr. Aisen to betraithe trust reposed in him by UCSD. Among other things, USC

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n or about May 2 015 offered Aisen a guaranteed salary of $5 00,000 per year through 2 02 0, and

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oth interest-free and low- interest financing on a new home, w ith forgiveness of at least half the

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ebt over time. The terms offered by USC were expressly set forth with the expectation that

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isen's salary would be paid by "ex tramural research funding you

[i.e.,

Aisen] obtain." Thus,

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hanks to Defendant U SC, D efendant Aisen has a strong personal financial incentive to interfere

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ith The Regents' contractual relationships with UCSD's research sponsors.

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efendants further agreed that USC w ould provide a "start-up loan" of up to $8

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illion to finance the creation of the new "Institute" in San Dieg o. In making these financial

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rrangements, Defendant USC expressly stated its expectation that Aisen would arrange a

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transition to USC" of existing research activities administered by UCSD, and that the new

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Institute" would incur real estate remodeling expenses only "if a relocation from current [UCS D-

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leased] facilities is required." Thus, thanks again to Defendant USC, Defendant Aiscn had a

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trong financial incentive to interfere with The Reg ents' relationships with the UC SD faculty and

3 employees who staffed the ADCS.

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he terms of Defendant USC's May 2015 offer to Defendant Aisen called for

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isen to join USC as of September 1, 2015. In accordance with the incentives he anticipated to

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eceive from US C, Dr. Aisen, w hile still employed by T he Reg ents, and in violation of his duties

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f loyalty and fidelity, began to recruit other UCSD employees to join him in his schem e to

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nterfere with the contractual relationships between UCSD and research sponsors, and to attempt

9 to interfere with UC SD's performance of its agreements both w ith the NIA and w ith private

10 sponsors of the ADCS.

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n May 2015, after entering into the conspiracy with USC, Defendant Aisen, using

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he authority of his position as director of the ADCS, summoned all ADCS employees to a

13 meeting and told them that he would likely be moving to USC, that the ADCS grants would move

14 with him, and falsely advised that none of the employees working on behalf of ADCS would have

15 jobs at UC SD. Aisen told the ADC S staff that USC w ould offer all of them jobs if they left -

16 UCSD. This conduct by Defendant Aisen created fear and unrest and concern among UCSD's

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mployees and disrupted their relationships with The R egents.

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efendants Jeremy Pizzola, Deborah Tobias, Gustavo Jimenez-Maggiora, Phuoc

19 Hong, Hong Mei Qiu, Stefania Bruschi, Jia-Sing So, and Mayya Nessirio, were UCSD employees

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ho agreed to join Defendant Aisen in a conspiracy to act as "double agents"— ostensibly

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mployed by The Regents but in reality working to undermine UCSD, to advance their own

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ersonal interests, and to serve the interests of Defendant USC , in violation of their obligations

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nder California Labor Code 2863, which states "An employee who has any business to transact

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n his own acc ount, similar to that entrusted to him by his em ployer, shall always g ive the

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reference to the business of the employer."

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or example, Defendants Aisen, Pizzola, and Tobias, while still employed by The

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ponsor and party to a Collaborative Study with the R egents, to terminate its contractual

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arrangement with The R egents and form a new contract with USC. O n May 30, 2 015 , Defendant

2 Pizzola wrote to Toyama.

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e believe that Paul [i.e., Defendant Paul A isen] can affiliate w ith

USC and form a new institution that would reside here in San

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iego. The new institute will hire on all of the staff members

currently working for Paul. We have discussed with USC and they

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ave indicated that they can issue replacem ent contracts to all

TC AD sites [i.e., research facilities under contract with The

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egents] simultaneously with precisely the same terms and

conditions. ... This w ould need to be very carefully timed w ith

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oyama as we believe Toyama could chose to cancel its agreement

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ith UCSD with 30 days notice.

In short we be lieve that we can have essentially the same people

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illing the same roles in the TCAD study simply under a new

institutional affiliation.

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oyama's representatives responded to Defendants Aisen, Pizzola, and Tobias on

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une 3, 2015 , stating in part, "Have you already discussed these with UCSD and NIH? It is

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mportant for Toyama to confer directly with UCSD to make sure that Toyama honors all of its

14 obligations to UCSD and complies w ith all applicable laws." How ever, rather than advise UCSD

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f Toyam a's inquiry, Defendant Pizzola replied "w e do not think it is time to discuss anything

16 w ith UCSD," and told Toyama "w e don't know w hat's going to happen with 11CSD."

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n June 8, 2015, Toyama wrote directly to Defendant Aisen, stating in part:

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fter carefully considering the actions that Jerem y

[i.e.,

Defendant

Pizzola] and you have recently requested of us, we find that the

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omplex ity of these requested actions raises a series of significant

logistical, contractual, and regulatory compliance issues.

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esolution of these issues, from both business and leg al

perspectives, requires us to consult with UCSD and its counsel. We

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hus request that, in addition to the project m eeting scheduled for

next w eek in San Diego, that you kindly arrange for us and our

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ounsel to meet separately with the appropriate representatives of

UC SD and its counsel so that this consultation can occur.

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2 4 Notwithstanding this explicit request from Toyama, Defendant Aisen concealed the

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omm unication from UCS D and its counsel, and accelerated Defendants' planned transition to

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n or about June 18, 2015, while travelling and away from San Diego, Dr. Aisen

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ent an email announcing that he would be resigning from UCSD effective July 1, 2015, to take a

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position at USC. That same day, UCSD Campus Counsel Dan Park sent Aisen a letter

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ongratulating Aisen on his job offer from U SC, and rem inding Aisen of hit fiduciary duties as

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irector of the ADCS , and an em ployee's duty of undivided loyalty to Ins employer during the

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erm of employment. Park's letter further stated:

In addition to avoiding any action that could disruptUC San

Diego's contractual relationships, you should be sure not to rem ove

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rom UC San Diego's possession or control any equipment, records,

electronic data, or software that w ere purchased or created for the

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DCS at UC San Diego. All such items are the property of UC San

Diego, the taking of w hich without UC San Diego's express

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ermission w ould be an illegal conversion.

Burlesei v . Petersen

(1998) 68 Cal.App.4th 1062. Conversion is a strict liability tort,

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mean ing questions of the defendant's good faith, lack of

know ledge, and m otive are ordinarily imm aterial." Id. Similarly,

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ou should not attempt to delete or destroy any records or

documents, w hether electronic or physical.

In summary, UC San Diego w ill be pleased to provide you w ith

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ssistance as you make you r transition to your new position. At the

same time, UC San Diego hopes that you will provide similar

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ssistance to ensure the continued smooth functioning of the ADCS

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t UC San Diego as w e prepare to search for a new director.

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fter receiving Park's letter requesting Aisen's compliance with legal obligations

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nd cooperation in transition, Defendant Aisen chose a diametrically opposite course. Without

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aving returned from his travels, on Sunday, July 21, 2015, Aisen sent an email stating, "Because

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f the tone and implications of the letter I received on 6/18/15 from U CSD general counsel, as

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ell as threatening statements made by UCSD leadership, it is untenable for me to remain at

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CSD through my planned resignation date. I resign immediately, effective today, 6/21/15."

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efendant Aisen refused to consent to an exit interview w ith any of his former

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olleagues at UC SD, and m ade no arrangem ents for the transition of his responsibilities as

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irector of the ADCS, despite multiple requests from UCSD.

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efendant Aisen and other Individual Defendants arranged for the return of the

25 laptop computers that had been issued to them and which w ere owned by The R egents. Each

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aptop had been wiped of all data, notwithstanding The Regents' ownership of the data.

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orse, upon their departure, and through the present, Defendant Aisen and the

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ndividual Defendants have exerted dominion and control over the ADCS data that has been

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entrusted to UCSD as a participant in the ADCS, 'and have failed and refused to provide UCSD

with account data, passwords, and access credentials to enable UCSD to maintain administrative

control of ADCS data, as set forth below.

Defendants Arrogate Control over ADCS Data After Resigning from The Regents

28.

One of the core functions that UCSD performs in connection with the ADCS is to

receive, monitor, and analyze clinical data from clinical trials and research studies that AD CS

administers. Such clinical data includes medical records of the individuals who have volunteered

to participate in a clinical trials of new drugs, and o ther information of a sensitive, confidential,

and proprietary nature. Such data is typically transmitted to ADC S from the various sites at

which clinical studies are conducted via an intend website with a unique U RL and stored on

computer servers. UCSD sometimes contracts with comm ercial vendors such as Amazon to host

ADC S data on their computer servers, colloquially referred to as "the Cloud."

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Maintenance of da ta pertaining to clinical trials is subject to detailed regulations

promulgated by the federal Food and Drug Administration (FDA). Maintenance of study data is

also subject to contractual obligations set forth in the contracts betw een The R egents and the

compan ies and governm ent agencies that sponsor clinical trials. Such contracts specify that all

data created or captured by UCSD related to the ADCS program will be jointly owned by The

Regents and the sponsors, and will be maintained by UCSD.

30.

For example, The R egents entered w ritten agreements with Eli Lilly and Company

("Lilly"), and the Toyama Chemical Company ("Toyama") with respect to research studies that

were ongoing at the time of Defendant Aisen's resignation, and remain ongoing today. A true and

correct copy, without exhibits, of The Regents' agreement with Lilly is attached hereto as Exhibit

"A" (the "Lilly Agreement"). A true and correct copy, without exhibits, of The Regents'

agreement w ith Toyama is attached hereto as Ex hibit "B" (the "Toyama Agreement").

31.

None of the Defendants are parties to the Lilly Agreement or the Toyama

Agreement.

32.

Pursuant to Section 18.1 of the Lilly contract, UCSD is required to create and

maintain all records required by the Agreement, and Section 16.1 provides that Study Data will be

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captured by UCSD and maintained jointly by Lilly and UCSD .

See Exhibit A. Pursuant to

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ection 16.2, the study data is jointly owned by Lilly and UCSD.

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ursuant to Section 8(C)(i) of the Toyama A greem ent, Clinical Study results shall

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See

Exhibit B. Pursuant

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o Section 8(C )(iii), all joint intellectual property created as a result of the clinical studies w ill

6 belong jointly to Toyama (and its parent company) and The Regents.

Id.

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he AD CS w as also partially funded by an aw ard from Department of Health and

8 Human Services, through the National Institutes of Health ("NN"), The terms of this funding are

9 set forth in the Notice of Award ("NOA") issued by NH on December 8, 2014. A true and

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orrect copy, without exhibits, of the NOA is attached hereto as Exhibit "C." (The financial

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nformation on this copy was redacted by the University's Department of Contracts and Grants in

12 connection w ith making the NO A publicly available.) Pursuant to the NOA, UCSD is expressly

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dentified as the grant recipient, and funding provided by the N IH is to be received by D efendant

14 Aisen "on behalf of UCSD."

See

Exhibit C at A ttachment B, p. 3. Further, the NOA expressly

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rovides that a principal investigator such as Defendant Aisen m ay not transfer the ADC S project

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o another host institution w ithout first securing advance approval from the N IH and a w ritten

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elease by 1JCSD approving the transfer.

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at Attachment B, p. 13. Representatives of NIH

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ave confirmed, following Dr. Aisen's resignation, that "UCS D is the grant holder and retains

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ustody of the data."

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n short, the contracts governing the ADCS make it abundantly clear that the data

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enerated by ADCS studies is to be maintained under the control of UCSD for the benefit of the

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tudy sponsors and The Regents, who are the owners of the data. There is no plausible

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nterpretation of the governing contracts that would accord D efendant Aisen or any of the

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ndividual Defendants the right, privilege, or pow er to assume control of AD CS data after

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evering their employment from UCSD, but this is exactly what Defendants have done.

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hile still employed by U CSD , Aisen and one or m ore of the Individual

2 7 Defendants, conspired to arrange for ADC S data to be hosted on an Amazon accou nt in the name

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f a party other than UCSD , presumab ly one or more of the Individual Defendants, or persons

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under their control. The account bears Amazon Account No. 67 5 7 1342 864 6. According to

UCSD accounting records, Amazon had invoiced UCSD , and The R egents has paid,

approximately $96,000 for the m aintenance of this account.

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After the resignations of Defendant Aisen and the other Individual Defendants,

representatives of UCSD made repeated requests that the Defendants turn over to UCSD all

account data, passw ords, and access credentials for any and all repositories holding AD CS data,

including Amazon Account No. 67 5 7 1342 864 6. The Individual Defendants failed to respond in

any substantive or meaning ful way, and have failed and refused to relinquish control of ADCS

data.

38.

On Sunday, June 28, 2 015, UCSD Dean and Associate Vice Chancellor Gary S.

Firestein, M.D., sent an urgent message to his counterpart at USC, Associate Dean for Clinical

Research Thomas Buchanan, stating, "Since Dr. Aisen is now an employee and agent of USC , w e

fomially request your assistance in directing D r. Aisen to turn over to UCSD all account data,

passw ords, and access credentials for any and all repositories holding A DC S data, of wha tever

kind or nature." Dr. Firestein's message was referred to USC Provost Michael Quick for

response. Mr. Quick responded on Monday, June 29, 2 015 , "I w ill assume that this issue of

access to data, etc., will get resolved today," but took no steps to do so, and the D efendants

continue to assert dominion and control over ADCS data.

39. UCSD has attempted to gain access to the Account No. 67 5 7 1342 864 6 through

Amazon; however, Amazon advised that, because the account is not held in the name of UCSD,

that Amazon regarded the account as "owned" by someone else, and Amazon's internal policies

prevented Amazon from identifying the "account holder," permitting UCSD to reset the password

to the account, or granting UCSD administrative control over the account. Amazon suggested

that UCSD either obtain the password from the "account holder," or get a court order. UCSD has

continued to work with Amazon in an attempt to gain full access and control over the account.

40.

The Defendants' exercise of dominion and control over ADCS data, including

Amazon Account No. 675 7 1342 864 6, causes harm to The Regents and to the ADCS in the

following ways:

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a.

ecurity patches and other maintenance operations such as software

upgrades cannot be conducted.

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b. ystem m onitoring is not possible, increasing the risk of hacker attacks and

3

ata breaches.

4

.

anagement of user accounts including the creation of new accounts,

updating permissions for existing accounts and rem oval of deprecated

5

ccounts is not possible leading to potential security vulnerabilities.

d.

Randomization codes may not be accessible, safety monitoring can be

compromised.

e.

Access to the ba ckend database is not possible, thus restricting reports to

8

hose that can be obtained through the existing web- based system.

9

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he codeba se cannot be inspected for potential security vulnerabilities

including potential backdoors into the system.

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he type or amount of services procured from Amazon cannot be

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ontrolled hence leading to potential abuse of acc ount billing.

12

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ll data are at risk for irreversible m anipulation, duplication and/or

deletion and the creation of local snapshots for data backup/history is not

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ossible.

41.

As a result of the conduct alleged herein, The Regents have suffered damages, and

will continue to incur damag es, in ways that w ill be subject to proof at trial.

FIRST CAUSE OF ACTION

(BREACH O F FIDUCIARY DUTY - AGAINST DEFENDANT AISEN)

42.

The R egents incorporates herein, by w ay of reference, all other paragraphs set forth

in this Com plaint in support of this cause of action.

43.

By virtue of being entrusted to act as The R egents' agent in serving as Director of

the ADCS, Defendant Aisen was a fiduciary to The Regents and owed fiduciary duties.

44.

Defendant Aisen breached his fiduciary duties by committing the acts complained

of herein.

45.

As a direct and proxim ate result of Defendant Aisen's w rongful and tortious

conduct, Defendant Aisen has becn unjustly enriched at the expense of The Regents, and The

Reg ents has suffered, and will continue to suffer, substantial damag es including, but not limited

to, costs incurred recovering data ow ned or controlled by The R egents, the loss of property owned

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ATToRNEts Ai LAW


5FACTIVE-903728301.I



THIRD CAUSE OF ACTION

(INTERFERENCE WITH CONTRACTUAL RELATIONS - AGAINST

AISEN, PIZZOLA, TOBIAS, USC, AND DOES 1-2 5 )

50.



51.

Valid contracts existed between The Regents and ccrtain third parties.

52.

Defendants knew of the existence of said contracts.

53.

Defendants intended to disrupt the performance of the contracts between The

Regents and certain third parties.

54.

Defendants' conduct made it more expensive and difficult for The Regents to

perform under its contracts w ith third parties, and, unless corrective action is taken by the court,

The R egents w ill likely be unable to perform at all under its contracts.

55.

By way of specific example, but not limitation, by exercising dominion and control

over Cloud-based storage accounts and preventing The Regents from exercising administrative

control over the data contained therein, Defendants h ave m ade it m ore difficult, if not impossible,

for The Regents to comply with Sections 16.1 of the Lilly Clinical Trial Agreement, which

requires UCSD to capture and maintain Study Data jointly with Lilly. Further, Defendants'

actions have made it difficult, if not impossible for The Regents to comply with Section 17.3 of

the Clinical Trial Agreem ent, which forbids either party from disclosing the confidential

information of the other.

56.

Defendants engaged in independently wrongful acts of conduct which violated

common and statutory law and which interfered with performance of the contracts and made The

Regents performance more expensive and burdensome. The full extent of Defendants' wrongful

conduct w ill be show n at trial after the opportunity for discovery,

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ROWELL

& MORING LLP

AMAMI Ai LAW





FOURTH CAUSE OF ACTION

(INTENTIONAL INTERFERENCE WITH PROSPECTIVE ECONOMIC

ADVANTAGE — AGAINST ALL DEFENDANTS)

57.



58.

Economic relationships existed between The Regents and the sponsors of the

ADCS, including Lilly, Toyama, and the NIA, containing a past and probable future economic

benefit or advantage to The Reg ents.

59.

Defendants knew of these relationships.

60.

Defendants intended to interfere with these relationships in order to foster their

own relationship with the AD CS sponsors, and the relationship between the Individual

Defendants and Defendant USC.

61.

As described m ore fully above, Defendants engaged in tortious and wrongful

conduct, including the conversion of UCSD property, damage to UCSD's network and systems.

62.

As a result of Defendants' tortious conduct, The Regent's relationship with the

ADC S program sponsors w as disrupted and UCSD has been harmed in w ays that will be shown at

t

rial. Defendants' conduct was a substantial factor in causing The Regent's harm.

FIFTH CAUSE OF ACTION

(COMMISSION OF COMPUTER CRIMES PURSUANT TO CALIFORNIA PENAL

CODE SECT ION 502 (C) AGAINST ALL DEFENDANTS)

63.


in this Complaint in support of the above- referenced cause of action.

64.

The acts described above, including the know ing and unauthorized actions and

attempts to access and download from The Regents' databases and other information stored on

The R egents' computers and com puter systems by D efendants, constitute a violation of one or

more of the following provisions of the California Penal Code, Section 502, which imposes

liability on one w ho:

• K nowingly accesses and w ithout permission alters, damages, deletes, destroys, or

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MORING LLP

ATTOIMEt9 AT LAW


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5EACTIVE-903728301.I



otherwise uses any data, computer, computer system, or computer network in order

2

o either (A) devise or execute any scheme or artifice to defraud, deceive, or extort,

3

r (B) w rongfully control or obtain m oney, property, or data;

4

nowingly accesses and without permission takes, copies, or makes use of any

5

ata from a computer, computer system, or computer network, or takes or copies

6

ny supporting docum entation, whether ex isting or residing internal or external to

7

computer, computer system, or computer netw ork;

8

nowingly and without permission uses or causes to be used computer services;

9

K nowingly accesses and w ithout permission adds, alters, damages, deletes, or

10

estroys any data, computer software, or computer programs winch reside or exist

1 1

nternal or external to a computer, computer system, or computer network;

12

nowingly and without permission provides or assists in providing a means of

1 3

ccessing a com puter, computer system , or computer netw ork in violation of this

14

ection;

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nowingly and without permission accesses or causes to be accessed any

16

omputer, computer system, or computer network; or

17

nowingly introduces any computer contaminant into any computer, computer

18

ystem, or computer network.

19 5 .

s a direct and proximate result of Defendants' wrong ful conduct, Defendants

20 have been unjustly enriched, and The Regents has been harmed and The Regents has sustained

21

amag es in an amount to be proven at trial.

2 2

6.

he Reg ents also has suffered irreparable harm as a result of Defendants' activities

2 3

nd w ill continue to suffer irreparable injury that cannot be adequately rem edied at law unless

2 4

efendants, and their officers, agents and employees, and a ll other persons acting in conceit with

25

hem, are enjoined from eng aging in any further such acts.

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CROwEic

& MORtNG LLP

Al7ORNEIS AT LAW




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SIXTH CAUSE OF ACTION

(CONVERSION- ALL DEFENDANTS)

67.


in this Complaint in support of the above-referenced ca use of action.

68.

The Regents owned all data related to the ADCS project, as well as the data and

contents of Amazon Account No. 675 7 1342 864 6, and the data contained on the UCSD laptop

computers issued to the Individual Defendants ("the ADCS Data").

69.

The Defendants, and each of them, have wrongfully exercised dominion and

control over the ADC S Data, and have intentionally and substantially interfered w ith The

Regents' ownership of the ADCS Data, as more fully in paragraphs 28-40 of this Complaint.

70.

As a direct and proxim ate result of the wrongful and tortious conduct of

Defendants as alleged herein, Defendants have been unjustly enriched and The Regents has

suffered, and w ill continue to suffer, substantial dama ges including, but not lim ited to, costs

incurred recovering data owned or controlled by The Regents, the loss of property owned by the

Regents, and costs incurred with repairing and monitoring UCSD's network, and in other ways

t

hat will be shown at trial. Defendants' actions were a substantial factor in causing The Regents'

harm.

SEVENTH CAUSE OF ACTION — ADDENDUM TO ALL CAUSES OF ACTION

(CIVIL CONSPIRACY — ALL DEFENDANTS)

71.


in this Complaint in support of the above- referenced cause of action.

72.

Defendants, and each of them, were aware the Defendant Aisen and Defendant

USC planned to interfere with The Regents' contractual and economic relations with the NIA,

with ADCS sponsors, and with UCSD employees, and that they planned for Dr. Aisen to act as a

double-agent by advancing his personal interests and those of USC while he was still employed

by The R egents.

73.

Defendants, and each of them, with full knowledge and intent and without

justification, agreed to act in concert with Defendants Aisen and USC to commit the tortious acts

CROWELL

&MORINO LLP

ATTOANLY3 AT LAW

16


5FACTIVE-903728301.1



against The R egents described in this C omplaint in order to further their personal financial gain

2 and to aid in the formation of their new 'venture, and to harm T he Regents and U CSD .

3

4 .

s a result of the w rongful and tortious conduct of Defendants as alleged herein,

4 Defendants have been unjustly enriched and The R egents has suffered, and will continue to suffer,

5

amages in ways and amounts that will be shown at trial.

6

HERE FORE , The R egents prays for Judgment against Defendants and each of them as

7 ollows:

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or compensatory damag es, according to proof;

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or preliminary and perm anent injunctive relief;

10

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or restitution and/or disgorgement of profits;

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or attorneys' fees;

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or costs of suit incurred herein;

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or a trial by jury; and

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or such other and further relief as the Court m ay deem proper.

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ATED: July 2 , 2 015

ROWELL 8 c MORING LLP

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y:

J. Daniel Sharp

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ark A. Romeo

Derek S. Hecht

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Attorneys for Defendant

The R egents of the University of California

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R O W E L L

Moinyc LLP

ATTORNEYS AT LAW


5FACTIVE-903728301.1



EXHIBIT A



Clinical Trial Research Collaboration Agreement

This Clinical Trial Research Collaboration Agreement ("Agreement") is entered into between Eli Lilly

and Company, an Indiana corporation ("Lilly"), and The Regents of the University of California, on

behalf of the University of California-San Diego Campus, on behalf of the Alzheimer's Disease

Cooperative Study) ("UCSD").

Introduction and Scope

WHEREAS, Lilly is committed to research and development in various therapeutic areas, including

Alzheimer's disease ("AD");

WH EREAS, U CSD possesses the comm itment and expertise to plan, engage in, and oversee the conduct

of research studies related to AD;

WHEREAS, UCSD and Lilly desire to work cooperatively in order to advance research in the AD field

by combining each party's expertise and commitment to making strides in this challenging disease state;

WHEREAS, UCSD and Lilly intend to work as partners throughout the clinical research contemplated

under this Agreement, including study design, study conduct, and data analysis;

WHEREAS, the clinical research contemplated under this Agreement is intended to involve Lilly's

investigational drug product solanezumab and Florbetapir F18 Injection, and Lilly will serve as the

regulatory sponsor of the study under applicable laws and regulations;

WHEREAS, the clinical research contemplated under this Agreement will be funded by a number of

public and private sources, including the National Institutes of Health ("NIH "), Lilly, and several

philanthropic organizations; and

WHEREAS, the clinical research contemplated under this Agreement is of mutual interest and benefit to

Lilly and UCSD and will further the research and development objectives of both parties.

NOW THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other

good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the

parties, intending to be legally bound, agree as follows:

Section 1

efined Terms

1.1

apitalized terms are defined in the attached Exhibit A.

1.2

or the purposes of this Ag reement, Lilly includes Avid R adiophannaceuticals, Inc, a

wholly owned subsidiary of Eli Lilly and Company.

Section 2

ackground

2.1

illy is a research-based company that develops, manufactures, markets, and sells

pharmaceutical and animal health products.

2.2

he Alzheimer's Disease Cooperative Study ("ADC S") is a cooperative agreement

betw een the National Institute on Aging and the University of California, San Diego.

ADCS works to facilitate the discovery, development and testing of new drugs for the

treatment of AD.

Page 1 of 40

Ex. A, Pg. 18



2.3

illy and UCSD wish to enter into this Agreem ent in order to facilitate a clinical research

study involving the Study Drugs in the field of AD, especially in brain amyloid elevated,

preclinical AD.

2.4

illy will serve as the regulatory sponsor for the Study for purposes of interacting with

regulatory authorities, and UC SD and L illy will be jointly conducting the study. The

nature of the collaboration is further outlined in the joint leadership group mem o, which is

attached as Exhibit F.

2.5

tudy Leadership. The A4 Partnership Leadership Team shall govern the study and shall

endeavor to reach con sensus on all decisions w ithin its jurisdiction, as further described in

Exhibit G.

Section 3

cope of Agreement

3.1

ssignment of Ob ligations. This Agreement serves to assign to Lilly and to UCSD certain

responsibilities imposed by applicable regulations that are outlined in this Agreeme nt and

its exhibits in connection with the conduct of the Study. UCSD and Lilly plan to work as

partners throughout the Study, including study design, study condu ct, and data analysis.

3.2

erformance Period. The effective period of this Agreement w ill be from the date of

execution of this Agreemen t until completion of the obligations established in this

Agreement and the Protocol, unless otherwise terminated in accordance with Section 11.

The effective period may be ex tended by the m utual written consent of the parties hereto.

3.3

ther Parties. Additional parties may provide in-kind and/or philanthropic support for the

Study only upon approval by Lilly, which may be withheld only in the event support would

jeopardize or conflict with Lilly's responsibilities as the regulatory sponsor or w ould result

in a conflict of interest. In addition, such support shall not be accepted from any

individuals, groups, or entities that appear on any go vernment list of restricted, sanctioned,

denied, or debarred parties.

UCSD's Rights and Obligations

Section 4

CSD's General Obligations

4.1

rotocol. UCSD s hall exercise reasonable efforts to conduct and manage the multi-c enter

clinical study as set forth in the Protocol, which w ill be agreed to by Lilly and UCSD as

soon as possible after this Agreement is signed and w hich will be attached as Ex hibit H

("the Protocol"). In the event of inconsistency between this A greement and the Protocol

and Study Operations Manuals, the terms of this Agreement shall govern, except that the

terms of the Protocol and Study O perations Manuals shall govern w ith respect to matters of

science, medical practice, and subject safety. In the event of inconsistency betw een the

Protocol and Study O perations Manuals, the Protocol shall govern.

4.2

hanges to Protocol and Operations Manuals. Unless there is an amendment needed for

urgent safety reasons, changes in the Protocol and Study Operations Manuals may be made

only through prior written agreement between Lilly and UCSD and, in the case of the

Protocol, may be implemen ted only after approval is granted by the applicable Institutional

Review Board ("TRW'). All changes to the Protocol and Study Operations Manuals

necessary for the safety of subjects shall be implemented immediately upon A4 Partnership

Leadership Team instruction and the applicable IRB approval.

Page 2 of 40

Ex.

A ,

Pg. 19



4.3

CSD sh all conduct the Study under the direction of Clinical Investigator, in accordance

with the Protocol, the terms and conditions of this Agreement, and all Applicable Laws.

4.4

he roles and responsibilities of UCSD in conducting and managing the Study are set forth

in Exhibit B . UC SD shall m ake available all personnel, facilities, and resources necessary

to efficiently and expeditiously accom plish its responsibilities under this Agreem ent.

4.5

harmacoviailance. UCSD will fulfill pharmacovigilance responsibilities listed in Exhibit

B and detailed in the Safety Plan (Exh ibit [J]), which w ill be in place prior to Study

enrollment. Obligations include notification of Lilly within twenty- four (24 ) hours of

receiving notification of any Serious Adverse Event (SAE) experienced by a subject

participating in the Study and receiving the Study Drug s.

4.6

linical Investigator. The Clinical Investigator is Paul Aisen, M.D., w ho w ill serve as

Investigator for the Study, as defined in 21 C .F.R. § 312 .3. The Clinical Investigator is

responsible for the management and direction of the Study in accordance with the Protocol,

and all Applicable Laws.

4.7

f for any reason, Dr. Aisen is unwilling or unable to continue to serve as C linical

Investigator and a successor who is acceptable to both Lilly and UCSD is not available, this

Agreem ent may be terminated as provided in Section 11. Prior to the comm encement of

the Study, UC SD shall provide to Lilly true, complete and correct copies of Dr. Aisen's

investigator statement on FDA Form 15 7 2 and curriculum vitae.

4.8

f for any reason the intended Project Director, Dr. Reisa Sperling, is unwilling or unable to

continue to serve as Project Director and a successor w ho is acceptable to both L illy and

UCSD is not available, this Agreement may be terminated as provided in Section 11.

4.9

CSD may contract with Participating Sites and sub-Investigators to conduct the Study.

Any Participating Site and sub- investigator used shall be subject to all of the terms and

conditions of this Agreement applicable to UCSD, and UCSD shall ensure that each

Participating Site and sub-investigator is aware of such terms and conditions. UCSD shall

ensure that each contract w ith a Participating Site and sub -Investigator includes a

representation that the Participating Site or sub- Investigator is not subject to any

obligations that would prevent it from complying with the applicable terms of this

Agreem ent. UCSD shall also ensure that each Participating Site signs the Investigator

Letter UCSD shall ensure that any sub-award contracts with Participating Sites and sub-

investigators are consistent with the relevant terms of this Agreem ent.

4.10

nstitutional Review Board. UC SD shall provide to Lilly documentation verifying review

and approval by the ap plicable IRB of the information to be provided to p otential subjects

of the Study to secure their informed consent, including information ab out any

compen sation being provided to Sub jects for participation in the Study, and the Protocol.

UCSD shall ensure that any applicable IRE(s) continues to monitor the Study during the

term of this Agreement in accordance with Applicable Laws and in any event at least once

per year and shall provide Lilly with docum entation of any applicable IRB's continuing

review contem poraneously therewith. UCSD shall promptly notify Lilly if any IRB takes,

or proposes, threatens or gives notice of its intent to take, any action that could reasonably

be expec ted to affect any duties or clinical activity under the Study , including the safety or

welfare of any Subject.

4.11

nformed Consent. UCSD shall obtain the informed consent of each Subject participating in

the Study in accordance w ith 21 C.F.R. parts 50 and 5 6, including the completion of an

informed consent form. Such form shall be reviewed and approved in advance by UC SD,

Page 3 of 40

Ex. A, Pg. 20



Lilly, and the appropriate IRB, prior to any Subject's screening o r participation in the

Study. Each informed c onsent shall include (a) safety profiles for the Study Drugs, as

provided by Lilly unless an IRB requires changes, and Lilly consents to such ch anges, (b) a

description of the situations under which Subjects w ill be reimbursed for treatment of

injuries related to their participation in the Study, and (c) data privacy terms that secure

access and usage rights to Study Data and biological samples as described in Sections 16

and 17.

4.12

inancial Disclosure Information. At Lilly's request, UCSD shall cause Clinical

Investigator to promptly provide to Lilly (a) financial disclosure statements in com pliance

with 21 C.F.R. Part 54, in the form required by Lilly and (b) such other financial

information as Lilly m ay reasonably request for the sole purpose of fulfilling its regulatory

responsibilities, including information docum enting the am ounts paid to each Investigator

participating in the Study. During the term of the Study and for a period of one (I) year

thereafter, UCSD shall cause Clinical Investigator and any Sub-Investigators to promptly

notify Lilly in writing of any substantive changes to su ch financial information.

4.13

roject Personnel. UCSD shall ensure that its personnel receive appropriate training,

including any training required by Applicable Laws or consistent with established ADCS

SOP, and the specifics surrounding the confidentiality obligations stated under Section 17 .

UCSD shall maintain accurate and current records of all training activities and retain such

records in accordance with the terms of this Agreement.

4.14

hanges in Services or Deliverables. If A4 Partnership Leadership Team ag rees to make

changes to the Study that alters the scope of work required under this Agreement or

otherwise makes modifications hi the Services or Deliverables being provided by UCSD,

UCSD and Lilly shall agree in writing on the resulting change an d the related costs or

savings, if any.

4.15

rants. UCSD shall be prohibited from establishing a clinical grant with an Investigator on

the behalf of Lilly that uses the outcome of the Study as a basis for com pensation or

requires payments to a spouse or dependent children.

4.16

onditions of NIH Funding. UC SD shall have sole responsibility for ensuring that the

conduct of the Study meets any requirements imposed by the NIH as a condition of

receiving a grant for partially funding the Study.

4 .17

nti-Bribery/Foreign Corrupt Practices A ct. In carrying out its responsibilities under this

Agreement, UCSD agrees to comply with all applicable anti-bribery laws in the countries

where UCSD has its principal place of business and where UCSD conducts activities under

this Agreement. Additionally, UCSD understands and agrees to comply w ith the U.S.

Foreign Corrupt Practices Act, as revised, w hich generally prohibits the offer, promise,

paym ent or giving of anything of value either directly or indirectly to any governm ent

official for the purpose of obtaining or retaining bus iness or any improper advantage. For

purposes of this section, "g overnment official" m eans any official, officer, representative,

or employee of, including any doctor employed by, any non-U.S. government department,

agency or instrumentality (including any government-owned or controlled commercial

enterprise), or any official of a pub lic international organization or political party or

candidate for political office. Additionally, if UC SD or any of its owners, directors,

employees, agents, and consultants are government officials, UCSD agrees that Lilly's

payment of UCSD in connection with this Agreement is not intended to influence any

decision that any individual may m ake in his or her capacity as a governm ent official.

UCSD further represent that neither UCSD nor any of its owners, directors, employees,

Page 4 of 40

Ex. A, Pg. 21



agents, or consultants w ill directly or indirectly offer to pay, promise to pay or give

anything of value to any g overnment o fficial for purposes of (a) influencing any act or

decision of such governm ent official in his official capacity; (b) inducing such governm ent

official to do or omit to do any act in violation of the law ful duty of such official; (c)

securing any imp roper advantage; or (d) inducing such gove rnment official to use his

influence with the governm ent or instrumentality thereof to affect or influence any act or

decision of the governm ent or such instrumentality w ith respect to any activities undertaken

relating to this Agreement. Additionally, UCSD will make reasonable efforts to comply

with requests for information, including answering questionnaires and narrowly tailored

audit inquiries, to enable Lilly to ensure compliance w ith applicable anti-bribery laws and

any applicable provisions of the Anti Bribery Commitments as revised by Lilly from time

to time and pub lished at http://supplierportal.lillv.com

or otherwise made available to

UC SD, to the extent consistent with UC policies. UC SD agrees that Lilly's payment to

UCSD in connection with the Services or Deliverables to be provided under this Agreement

is not intended to influence any decision UCSD may make regarding the prescription of

Lilly medicines or to otherwise influence any pend ing or future Lilly business.

Section 5

CSD's Certifications, Representations and Warranties

5.1

CSD certifies that:

5 .1.1 Neither UCSD nor any other Person who provides Services or Deliverables for

Lilly or satisfies any other obligation of UC SD under this Ag reement is prohibited

from doing so by any legal obligation or restriction, including any Applicable Laws

or contractual comm itment.

5 .1.2 U CSD's performance under this Agreement com plies with all Applicable Laws and

with any relevant description or specification in this Agreement.

5 .1.3 Services and Deliverables will be rendered w ith at least that degree of skill and

competence reasonably expected of, and in accordance with any codes of conduct

commonly recognized by, Persons who perform similar Services in the country in

which the Services are performed.

5.1.4

bligations of Clinical Investigator. Clinical Investigator is, and at all times during

the course of the Study shall be, qualified, by training and experience, and w ith

appropriate expertise to conduct the Study. UC SD shall cause C linical Investigator

and Participating Sites and sub-investigators to perform the Study appropriately,

professionally and efficiently, which includes: (a) exercising independent medical

judgment as to the compatibility of each Subject with the Protocol requirements;

(b) ensuring that each Subject is provided with information about the Study, has

been given an opportunity to ask questions about the Study and his involvement,

and has received answers to all such questions; (c) ensuring that UCSD has

obtained the informed conse nt of each of the Subjects participating in the Study;

(d) reviewing all case report forms for accuracy and com pleteness; (e) submitting

all Study Data in a timely manner; (f) notifying UCSD's IR B imm ediately of any

unanticipated or serious adverse reactions to the Study Drug; (g) m aintaining

adequate and correct records of Subject identification, clinical observations,

laboratory tests and drug receipt and disposition; (h) cooperating w ith Lilly in all of

its efforts to monitor the Study; and (i) notifying UCSD immediately of any SAEs.

5 .1.5 Licenses, Approvals and Certifications. UCSD and Clinical Investigator have, and

at all times during the course of the Study shall have, the appropriate licenses,

Pages of 40

Ex. A, Pg. 22



Section 6

approvals and certifications necessary to safely, adequately and law fully perform

the Study.

5 .1.6 Absence of Conflicts. No UCS D personnel or Clinical Investigator or any other

person involved in performing the S tudy is, or at any time du ring the course of

their involvement with the Study shall be, subject to any conflicting obligations or

is party to any conflicting arrangements that might interfere with the performance

of the Study or that might impair the acceptance of the resulting data by the FDA.

5 .1.7 U CSD and Clinical Investigator are entering into a collaborative arrangement w ith

Lilly to conduct the Study b ased on the scientific merits of the project and not, in

any w ay, as an inducem ent to, or in return for, past, present or future prescribing,

purchasing, recommending, using, dispensing or granting preferential formulary

status for any Lilly product.

5 .1.8 Privacy and H 1PAA. U CSD represents, warrants and covenants that it and Clinical

Investigator are "Covered Entities" under the provisions of the Health Insurance

Portability and Accountability Act of 1996 and any regulations and official

guidance promulgated thereunder ("HIPAA" ). UCSD shall, and shall cause

Clinical Investigator to, handle all Study Data (including Subjects' me dical

records) in accordance with HIPAA requirements and all other Applicable Laws

and shall ensure that they obtain from each Sub ject a valid authorization that

complies with HIPAA, and is, in form and substance, acceptable to Lilly,

permitting UCSD and Clinical Investigator to provide Lilly with the Study Data as

contemplated hereby and to satisfy their other obligations under this Agreement

with respect to the Study D ata or with the applicable provisions of Lilly's Vendor

Privacy and Security Standard as revised by Lilly from time to time and published

at htto://supolierportal.com

or otherwise made available to UCSD and to the extent

consistent with UC policy. UCSD acknowledges and agrees that no component of

Lilly or any of its affiliates that will be performing Lilly's obligations under this

Agreement (a) is a "Covered Entity" for purposes of HIPAA, (b) will become a

"Business Associate" of a Covered Entity for purposes of HIPAA by performing its

obligations under this Agreement, or (c) is otherwise governed by HIPAA.

Debarment and Exclusion from Certain Health Care Programs

6.1

CSD represents and warrants that it has not been:

6.1.1 Debarred by the FDA under any provision of the Generic Drug Enforcement Act;

6.1.2 E xcluded by the O ffice of the Inspector General of the United States Department of

Health and Human Services, or by any other authority, from participating in any

health care program (such as Medicare or Medicaid) funded by any Governmental

Authority; or

6.1.3 . Deb arred or disqualified from participating in clinical research by any other

Governmental Authority.

6.2

CSD agrees that no Person who has been debarred or excluded as described above will

furnish any of the Services or Deliverables or perform any of UC SD's obligations under

this Agreement.

6.2.1 UCSD will immediately notify Lilly in writing of any actions taken or proceeding

pending that threatens or confirms a debarment or exclusion of any such Person.

Page 6 of 40

Ex. A, Pg. 23



Lilly's Rights and O bligations

Section 7

illy's General Obligations

7.1

illy shall be the Sponsor of the Study, as defined in 2 1 C.F.R . § 312 .3. For the purpose of

the study UCSD and Lilly plan to work as partners throughout the A4 study, including

study design, study conduct, and data analysis.

7 .2

he roles and respon sibilities of Lilly are set forth in E xhibit B.

7.3

ubject to UCSD's material compliance with its obligations under this Agreement, Lilly

will provide partial funding in support of the Study in accordance w ith Exhibit I.

7 .4

illy shall be responsible for obtaining all necessary reg ulatory approvals for the condu ct of

the Study. Lilly will keep UC SD informed regarding the status of regulatory approvals.

7.5

illy shall be responsible for com plying w ith applicable requirements to register the Study

and results on clinicaltrials.gov

or any other database for w hich registration is required by

Applicable Law s. Any such results will be calculated using a mutually agreed upon

statistical analysis plan.

7.6

illy may contract w ith contract research organizations or other third parties to conduct the

Study. Any vendor or CR O used shall be sub ject to all of the terms and conditions of this

Agreement applicable to Lilly, and Lilly shall ensure each is aware of such applicable terms

and conditions.

Section 8

rovision of Study Drugs

8.1

erms of Supply. Lilly shall provide UCSD w ith the Study Drugs free of charge, in

accordance w ith the Protocol, solely for UCS D's performance of the Study. Lilly retains

all right, title and interest (collectively, "Rights") in and to the Study D rugs. UC SD shall

not, without L illy's prior written permission, (i) use the Study Drugs for any purpose other

than the performance of the Study, (ii) provide the Study Drugs to any third party (except a

contract research organization or other third party receiving Study Drugs und er the

Protocol), or (iii) take the Study Drugs to any location other than an investigational study

site. UCSD shall not, and shall cause Clinical Investigator not to, modify or alter the Study

Drugs in any m anner. Upon termination or completion of the Study, UC SD shall, at Lilly's

direction, either return to Lilly any quantities of unused Study Drugs, or dispose of the

same, in any event in accordance w ith Lilly's written instructions. UCSD shall m aintain

comp lete and accurate records relating to the disposition of all Study Drugs supplied to

UCSD.

8.2

isclaimer. Without limiting Lilly's obligations under section 22 , LILLY DOES HEREB Y

DISCLAIM ANY AND ALL WARRANTIES, WHETHER W RITTEN OR ORAL,

EXPRESS OR IMPLIED, WITH RESPECT TO THE STUDY DRUG, INCLUDING ANY

WARRANTY OF QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS

FOR A PARTICULAR USE OR PURPOSE, OR THAT THE USE OF THE STUDY

DRUG (FOR PURPOSES OTHER THAN THOSE CONTEMPLATED BY THIS

AGREEMENT) WILL NOT INFRINGE THE RIGHTS, PATENT OR OTHERW ISE, OF

ANY THIRD PARTY.

Section 9

illy's Representations and Warranties

9.1

illy represents and warrants that:

Page 7 of 40

Ex. A, Pg. 24



9.1.1 Neither Lilly nor any other Person who performs any obligation of Lilly under this

Agreement is prohibited from doing so by any: (a) Applicable Laws; (b) covenant

not to com pete; (c) contract to deal exclusively with another Person; or (d) other

legal or professional obligation or restriction.

9.1.2 T he performance of Lilly's responsibilities under this A greement and Lilly's use of

the Services and Deliverables comply with all Applicable Laws.

Payments

Section 10 UCSD's Invoices

10.1

chedule. Except to the extent provided by the Statement of Work (Exhibit B) or the

Budget (Exhibit I), UCSD will submit invoices on the following schedule:

10.1.1 For hourly fees, for unit-based fees, and for reimbursement of expenses: once a

month, as accrued or incurred.

10.1.2 For fixed fees: after Lilly has received and accepted all Services and Deliverables

subject to the fixed fee.

10.2

orm and Supplemental Information. Each invoice submitted by UCSD must comply with

Lilly's standard forms and procedures (as changed from time to time), to the extent

consistent with UC SD's standard invoice, and published on the intemet at

lutp://supplierportaLlilly.com

and with any specific requirements in this Agreement. Lilly

may at any time request additional invoice information as needed. As requested, each

invoice will be hccompanied by any information required by this Agreement or that Lilly

may reasonably request, including detailed information for any amounts of Taxes UCSD is

collecting from L illy.

10.3

urrency. Invoices will be stated in United States Dollars.

10.4

ayment Term s. Payment w ill be due sixty (60) days after Lilly's Accounts Payable

Department receives an invoice that complies with the requirements of this Agreement,

except that Lilly may withhold payment of any amount that it may reasonably dispute in

good faith until such dispute is resolved. Payment by electronic transfer will be made on

the payment date. Payment by check w ill be mailed on the payment date.

10.5

urrency. Payment w ill be in United States Dollars.

10.6

he funding agreed to by Lilly pursuant to this Agreement is based on 1,000 subject

enrollment only. Any increase to the subject population due to sample size re-estimation

will be made only by written agreement between Lilly and UCSD. Additional funding by

Lilly as a result of this re-estimation will occur only by written agreement between Lilly

and UCSD.

Right to Terminate

Section 11 Termination of Agreement

11.1

his Agreement may b e terminated by either party upon thirty (30) days' prior Niiritten

notice if the other party m aterially breaches any of its obligations or p rovisions of this

Agreement and has not cured the breach during such period.

Page 8 of 40

Ex. A, Pg. 25



11.2

CSD may terminate this Ag reement on ninety (90) days' prior written notice if it is not

financially, adm inistratively, or scientifically feasible for UCSD to continue the S tudy.

11.3

illy may terminate this Agreem ent on ninety (90) days' prior written notice if for any

reason Lilly deem s its sponsorship of the S tudy no long er financially or scientifically

feasible, including if UCSD fails to timely obtain N11-1 funding in the amount of $36

million or if Lilly determines, as a result of a pre-Study enrollment audit, that UCSD does

not possess the necessary facilities, personnel, or abilities to adequately perform its

obligations under this Agreement.

11.4

his Agreement may be terminated immediately: (a) for safety reasons as in good faith

determined by either UCSD or L illy, (b) if the FDA requests the Stud y be terminated, (c) if

UC SD's IRE orders the Study terminated, or (d) the Drug Safety M onitoring Board

recommends this course of action in accordance with the charter.

11.5

pon termination for any reason, Lilly shall promptly provide paym ents for all work

completed and non cancellable costs incurred by UCSD in accordance with Exhibit I.

Upon termination for any reason, UCSD shall (a) promptly refund any amounts paid to

UCSD that exceed L illy's obligation to pay for work ac tually performed, (b) provide a

summary status report of the Study, including subjects enrolled, statement of work, and

summ ary of data collected; and (c) deliver to Lilly all unused Study Drug s and any other

information or property in the possession or control of UCSD that was su pplied by Lilly or

derived from the Study that Lilly may request under the terms of this Agreement.

11.6

n the event that the Study is terminated under this Section, the A4 Partnership Leadership

Team shall determine an appropriate course of action with regard to winding down the

Study or w hether the Study shall continue. Except in the case of termination as a result of

an uncured breach of this Agreement by UCSD, Lilly shall reimburse UCSD for its

reasonable and verifiable direct costs incurred in connection w ith any such transfer or

winding down of the Study.

11.7

ermination of this Agreem ent by any pa rty shall not affect the rights and obligations of the

parties accrued prior to the effective date of the termination. The rights and duties under

sections 12 through 17, 19, and 22 survive termination or expiration of this Agreement.

Information and Property Rights

Section 12

ublications

12.1

illy encourages the pub lication of Study Data in reputab le scientific journals and at

seminars or conferences. UCSD has the sole and irrevocable right, consistent w ith

academic standards, to pub lish the first manuscript containing results of the Study. This

sole right to publish the Study Data shall survive the agreem ent if Lilly should choose to

sell or otherwise relinquish its rights and property to another entity. UC SD shall be

responsible for facilitating timely disclosure of the p rimary publications reporting results of

the Study, and it is anticipated that the results of the Study w ill be published in a joint

multi-center prim ary publication including Lilly authors, as scientifically appropriate, and

consistent with the publication plan. UCSD will prepare a proposed disclosure plan for the

primary m ulticenter publication, including proposed title or topic, journal or congress, and

subm ission date for the primary multicenter publication disclosures and provide to Lilly

before database lock. UCSD will coordinate the publication of the primary manuscript to

simultaneously occur w ith the first disclosure of primary Study results at a scientific

Page 9 of 40

Ex. A, Pg. 26



meeting. Submission of the primary publication is to occur no later than 6 months, unless

mutually agreed to be extended by the parties, following the Study database lock if

simultaneously pub lication and presentation is not feasible. The primary publication shall

include the results of the primary efficacy measures as prespecified in a m utually agreed

upon statistical analysis plan and may co ntain other key secondary efficacy m easures if the

parties mutually agree to such secondary efficacy measures and whether to include them

within the primary publication.

12.2

rior to submission for publication or presentation, UCSD shall provide Lilly with at least

thirty (30) days for review and com ment on the m anuscript. Lilly has the right to review all

proposed UCSD publications, manuscripts, and presentations of the results of the Study and

to require (1) the deletion of Lilly Confidential Information and/or (2 ) postponem ent of the

publication, manuscript, or presentation for no m ore than 90 days in order to protect the

Intellectual Property Rights of either party. The parties will work coo peratively to ensure

the accuracy of statem ents in registries, publications, m anuscripts, and presentations

relating to the Study Drugs.

12.3

f UCSD seeks to register the Study or publish the Study results on a web-based registry

other than clinicaltrials.gov or any other database for w hich registration is required by

Applicable Laws, UCSD shall provide Lilly with the proposed registration or publication

information at least thirty (30) days in advance, and Lilly shall have the right to review

such information and to req uire (1) the deletion of Lilly Confidential Information and/or (2 )

postponement of the release of such information for no more than 90 days in order to

protect the Intellectual Property Rights of either party.

12.4

ubject to the same review process in Section 12.2, Lilly and UCSD will each have the

right to make follow-up publications, and the parties will exercise good faith efforts to

coordinate such pu blications in order to avoid identical or overly sim ilar publications.

UCSD will provide to the A4 Partnership Leadership Team a record of all planned platform

presentations, poster presentations, or publications. Similarly, Lilly w ill provide to the A4

Partnership Leadership Team a list of all presentations or publications planned by L illy

employees at scientific meetings or in scientific journals. The A4 Partnership Leadership

Team or their designees will review and discuss the publication plans of Lilly and UCSD

on an as needed basis. A L illy publication coordinator will assist the A4 Partnership

Leadership Team and authors in com plying with any applicable Lilly publication

procedures and processes.

Section 13

illy Property

13.1

CSD a cknow ledges that Lilly ow ns the entire rights, title and interest in Lilly Intellectual

Property and certain processes, know-how, trade secrets, improvements, Records,

Confidential Information, other assets, including but not limited to, the Stud y Drug

compounds, database design and an interactive voice study drug randomization system to

assign treatments, dispense drugs, monitor clinical supply inventories and obtain data

during clinical studies (collectively "Lilly Property"). UC SD, as w ell as its Affiliates,

agents, and ven dors, shall be bound to the terms of confidentiality as set forth in this

Agreement with regard to such Lilly Property and shall not share such Lilly Property with

other sponsors for whom they may later perform w ork or other third parties. Nothing

contained in this Agreement shall be construed as a license to UCSD to any proprietary

rights of Lilly, including but no t limited to, patent rights to mak e, sell, reverse engineer, or

prepare derivative works based upon the L illy Property, or any part thereof, outside the

purposes contemplated by this Agreement.

Page 10 of 40

Ex. A, Pg. 27



Section 14 UCSD Property

14.1

illy acknowledges that UCSD possesses certain processes, know-how, trade secrets,

methods, approaches, analyses, improvements, Records, Confidential Information, and

other assets, including but not limited to, clinical trial manag ement analyses, analytical

methods, procedures and techniques, computer technical expertise and proprietary

software, and technical and conceptual ex pertise in the area of conducting clinical trials, all

of which have been developed independently by UCSD without the benefit of any

information provided by Lilly (collectively "UCSD Property"). Lilly agrees that any

UCSD Property or improvements thereto which are used, improved, modified or further

developed by UCSD under or during the term of this Agreement are the sole and exclusive

property of UCSD. Ex cept as provided below, nothing contained in this Agreem ent is to be

construed as a license to Lilly under any proprietary rights of UCSD, including bu t not

limited to patent rights to make , use, sell, reverse engineer, or prepare derivative works

based upon UCSD Property, or any part thereof, outside the purposes contemplated by this

Agreement.

Section 15

ntellectual Property Rights

15.1

illy shall maintain ownership of its ex isting intellectual property related to Study Drugs

and its method of use, whether patentable or not.

15.2

o the extent legally possible, Lilly shall be granted a worldwide, non-exclusive, royalty-

free license, to any patents and patent applications that necessarily use, incorporate, or are a

result of the Study Drugs provided by Lilly pursuant to this Agreement, including any

patents or patent app lications filed by third parties as a result of acce ss to Study Data

pursuant to Section 15 .5 of this Agreement.

15.3

illy shall be free, in its sole discretion, to distribute the Study Drugs to othe rs and to use

them for its own purposes.

15.4

CSD shall use reasonable efforts to assist Lilly in complying w ith the requirements of

The Bayh-Dole Act of 1980 (Public Law 96-5 17; 35 U.S.C. §§ 200-2 12).

15.5

ubject to Sections 12, 13, 14, 16, 17, and 18 of this Agreement, and its obligations to

maintain patient confidentiality, UCSD shall have the right to m ake available, in whole and

in part, any final Study Data to third parties. Such disclosure shall not occur before

publication of the primary manuscript referenced in Section 13. Consistent w ith NIH data

sharing policies and precedents, UCSD may make the Study Data available only upon a

written request containing a prohibition on using su ch data as part of a filing with a

regulatory authority, whether for a marketing ap plication or supplement or investigational

drug application. Such written request must also contain an acknowledgement that Lilly

will retain rights to the patents and patent applications as outlined in Section 15 .2 o f this

Agreement.

Section 16 Rights to Study Data

16.1

tudy Data will be captured by UCSD and maintained jointly by Lilly and UCSD.

16.2

tudy Data w ill be jointly ow ned by Lilly and UC SD. Lilly has the right to obtain a copy

of the Study Data, as well as copies of all regulatory-required Study documentation,

including, but not lim ited to, any IRB approval notifications, investigator qualifications,

Page 11 of 40

Ex. A, Pg. 28



and Study subject records, as needed to support a regulatory application or submission in

relation to Study drugs or for use as outlined under this Agreement and for other reasonable

purposes.

16.3

iological samples taken during the course of the Study w ill be retained by U CSD or Lilly

for future research purposes. Biological samples related to treatment response shall not bp

provided to any third-party without the prior w ritten authorization of Lilly which shall not

be unreasonably withheld. UCSD shall ensure that the informed consent form for the Study

informs Subjects that such samples w ill be retained by UC SD or Lilly and used for further

research but only if the Subjects opt-in for the future use. Lilly and UC SD shall have the

right to access and perform research under this Agreement on the samples related to

treatment response with prior w ritten notice to the other party. Any publications arising out

of the biological samples shall follow the pub lication process outlined in Section 12 of this

Agreement. UC SD and Lilly agree to further work through the specifics surrounding the

biological samples through amending the Statement of W ork or entering into a W ork Plan

process as outlined in this Agreement. A ny disputes related to the biological samples shall

be vetted through the A4 Partnership Leadership Team as further described in Exhibit G.

16.4

otwithstanding any provision in this Agreement to the contrary, data and publication

rights w ill be governed by the N ational Institutes of Health's Grants Policy (dated Octob er

2011), including the requirement that N IH be given a royalty-free, nonexclusive, and

irrevocable license for the U .S. Federal government to reproduce, publish, or otherwise use

the Study Data and to authorize others to do so for Federal purposes. Consistent w ith this

policy, each publication, press release, or other public document about the S tudy shall

contain an acknowledgment of N IH support and a disclaimer stating that the content does

not represent the official views of the NIH.

Section 17

onfidential Information

17.1

illy shall only disclose confidential information necessary for Institution's performance of

the Study. "C onfidential Information" shall m ean and include all data and other

information which are disclosed by Lilly to UCSD for the purposes of conducting the Study

which is marked as "C onfidential" at the time of disclosure, or (i) in the case of oral

disclosures, identified at the time of such oral disclosure as confidential and reduced to

writing and m arked as "Confidential" within thirty (30) days of oral disclosure; (ii) if not

marked, regarded as confidential if a reasonable person in the relevant field would consider

such information to be the Company's confidential information given its content and the

circumstances of the disclosure. The parties anticipate that each party has already or m ay

acquire or have access to C onfidential Information ow ned by the other party, including but

not limited to the following types: research and developm ent plans and results; new

compounds and processes; evaluation procedures (including clinical and field testing);

product formulations; manufacturing methods; applications to g overnment authorities;

pricing or cost; c onstruction plans; sales, marketing, and advertising studies and plans;

customer lists; computer information and softw are; special techniques unique to each

party's business; information subject to a right of privacy; and information each party

maintains under a system of protection against unauthorized access. The parties w ill

cooperate to ensure that C onfidential Information does not inhibit or prevent publication

including publication required by any Federal sponsor.

Page 12 of 40

Ex. A, Pg. 29



17.2

he Confidential Information provided to the receiving party w ill remain the p roperty of

the disclosing party.

17.3

illy and UCSD will neither:

17.3.1 disclose the other party's Confidential Information except as authorized below or

by the other party in w riting; nor

17.3.2 use the other party's Confidential Information for any purpose other than the

purpose of this Agreement.

17.4

n executing the o bligations in this Section 17 , each party shall use a standard of care at

least as stringent as each party uses to protect its ow n Confidential Information and in any

event, using no less than a reasonable standard of care.

17.5

ach party shall restrict the dissemination of the Confidential Information w ithin its own

organization to only those persons who have a need to know it, and shall ensure that all of

its employees and representatives involved in carrying out this Agreement and the Study,

including Clinical Investigator, (a) are aw are that the Confidential Information is

confidential and (b) are bound by obligations of confidentiality and non-use at least as

protective of the Confidential Information as those set forth in this Agreem ent.

17.6

ach party may disclose the other party's Confidential Information only (a) to ADCS

employees, (b) to those other persons who require access in order to perform obligations

required under this Agreement and who have contractual obligations that prohibit any

disclosure and use of the Con fidential Information prohibited by this Agreeme nt, or (c) to

the extent compelled by Applicable Law s. If permitted by Applicable Law, each party w ill

provide the other w ith reasonable advance notice of the disclosure.

17.7

he obligations of confidentiality in this Section 17 sha ll not apply to information that: (a)

is published or otherwise ge nerally available to the public at the time of disclosure other

than by reason of breach of the provisions of this Agreement; (b) becomes publicly known

subsequen t to disclosure by either party other than by reason of b reach of the provisions of

this Agreement; (c) either party can demonstrate by competent evidence was in its

possession at the time of disclosure and was n ot acquired directly or indirectly from the

other party; or (d) either party can demonstrate by competent evidence was developed by

the party without the use of, and independent from, any information received from the other

party.

17.8

romptly upon termination, expiration, or cancellation of this Agreement, each party will

delete or destroy all Records of the other party's Con fidential Information in each party's

possession or control (if such Records are not the property of the other party). For the

purpose of Electronic Records, "destroy" includes destroying the physical medium on

which a Record is stored or completely and permanently removing a Record from its

storage medium.

17.9

otwithstanding anything to the contrary in this Agreement, each party may make and

retain one (1) Record of the other party's Con fidential Information so lely for its legal

archives.

17.10

he prohibitions on disclosure and use of C onfidential Information shall survive for seven

(7) years after the end o f the study, termination, or cancellation of this Agreemen t or after

UCSD returns or destroys all Records of the relevant Confidential Information in its

possession or control, whichever is later. The foregoing notw ithstanding, the restrictions

on prohibition or use of Lilly's Trade Secrets shall survive for as long as the information

Page 13 of 40

Ex. A, Pg. 30



satisfies the definition of Trade Secret, provided that Lilly informs UC SD in w riting at the

time of disclosure that the information constitutes a T rade Secret.

Section 18 Records and Audits

18.1

ecords That Must Be C reated and Maintained. UCSD w ill create and maintain all

Records: (a) required by this Agreement and Applicable Laws that relate to this Agreement

and to UCSD's performance under this Agreement; and (b) sufficient to enable Lilly to

comply with Applicable Laws and other legal obligations, to the extent that UCSD has or

reasonably should have knowledge of those Applicable Laws and other legal obligations.

18.2

eriodic Reports. UC SD shall, and shall cause C linical Investigator to, provide Lilly, in

writing, w ith data and results arising from the performance o f the Study, at such intervals as

Lilly shall reasonably request. Lilly shall have free access to all Study D ata, provided,

how ever, that the confidentiality of Subjects' identifiable health information shall be

maintained to the extent required by Applicable Laws.

18.3

ecord Retention Periods. The Records required to be maintained under this Agreement

shall be retained by UCSD for fifteen (15) years commencing upon conclusion or

termination of the Services. After the applicable Records retention period ends, at the

request of UC SD and at Lilly's direction, such Records shall be delivered to Lilly, be

destroyed, or be retained by UCSD for a standard storage fee to be agreed upon by the

parties.

18.4

ccess to Participating Sites and R ecords. Lilly or its authorized representatives or

designees shall have the right, w ith reasonable advance no tice, at Lilly's cost, and during

business hours, to audit Participating Sites and Study Records at reasonable times and with

reasonable advance notice for regulatory purposes, for ensuring that UCSD is in

compliance with the terms of this Agreement.

18.5

IH Records and R eports. UCSD shall have sole responsibility for maintaining any

Records that are required as a con dition of the grant received by UC SD to partially fund the

Study. UCS D shall also have sole responsibility for any comm unications with NIH,

including reports on the Study. Lilly shall have the right to review reports related to the

study before submission to NIH.

Section 19 Nondisclosure, Publicity, and Use of Lilly Name or Trademarks

19.1

either party shall use the name, insignia, sym bol, trademark, trade name or logotype of

the other party in any press release, advertising or m aterials distributed to p rospective or

existing customers, annual reports or any other public disclosure, except with the other

party's prior written authorization or as required by Applicable Law s. To the extent

allowed by Applicable Laws, each party will provide copies of any proposed disclosure for

prior review and comment by the other party no less than ten (10) days prior to disclosure.

19.2

oth Lilly and UCSD agrees to confer with the other before responding to inquiries by

journalists or financial analysts related to the Study and ag ree upon a m utual external

communication coordination process within a reasonable time after execution of this

Agreem ent. In responding to such inquiries, the parties will endeavor to distinguish

betw een the roles and responsibilities of various entities. In particular, when discussing

interactions with regulatory authorities (such as IND filings, safety reports, etc.), it may b e

helpful to note that Lilly is the regulatory sponsor of the Study under A pplicable Law s.

When discussing the overall management and conduct of the Study, it may be helpful to

Page 14 of 40

Ex. A, Pg. 31



note that the A4 ADC S/Lilly Partnership w ill be jointly conducting the Study. Finally,

whe n discussing financial support for the Study, it may b e helpful to note that NIH, L illy,

and m ultiple philanthropic organizations have provided funding for the Study.

19.3

n no event will UCSD:

19.3.1 represent, directly or indirectly, that any product or service provided by U CSD has

been approved, recommended, certified or endorsed by Lilly; or

19.3.2 use Lilly's name, logo, or other trademarks on any business cards, letterhead, or

similar m aterials.

19.4

illy may, in its sole discretion, revoke any authorization or consent given under this

Section 19.

. R isk A llocation

Section 20 Remedies

20.1

he naming of a specific remedy does not preclude any other remedy unless this

Agreement clearly states that the specified remedy is the sole or exclusive remedy.

20.2

CSD acknowledges that monetary damages are inadequate to protect Lilly from a breach

or threatened breach of UC SD's duty to protect Lilly's Confidential Information and that

any such breach w ill cause irreparable harm to Lilly. Accordingly, Lilly may seek an

injunction restraining any breach or threatened breach without having to prove the

inadequacy of monetary dam ages or irreparable harm.

20.3

illy acknowledges that monetary damages are inadequate to protect UCSD from a breach

or threatened breach of Lilly's duty to protect UC SD's Confidential Information and that

any such breach will cause irreparable harm to UCSD. Accordingly, UCSD may seek an

•

njunction restraining any breach or threatened breach without having to prove the

inadequacy of monetary damages or irreparable harm.

Section 2 1

nsurance

21.1

CSD and Lilly will satisfy the requirements of the Insurance Exhibit.

Section 22

ndemnification

22.1

y Lilly. Lilly agrees to indemnify, defend, and hold harmless UCSD and its officers and

administrators, trustees, directors, employees and agen ts, including Clinical Investigator

(collectively, the "UCSD Indemnitees"), from and against any and all claims, damages,

liabilities, losses, costs and ex penses (collectively, "Claims" ) for any personal injury

(including death) to Subjects directly arising from the adm inistration or use of the Study

Drugs or any clinical intervention or procedure provided for or required by the Protocol to

which Subjects would not have been exposed but for their participation in the Study

pursuant to the Protocol, except to the extent that such C laims arise from: (a) the violation

by any UCSD Indemnitee of the Protocol; (b) the breach by any UCSD Indemnitee of the

terms of this Agreement, including UCSD's failure to obtain from each of the Subjects

participating in the Study the informed consent described; (c) the violation by any UCSD

Indemnitee of any Applicable Laws; (d) the negligence, recklessness or willful misconduct

of any UCSD Indemnitee; (e) any natural processes or complications of an underlying

illness, or any other illness or injury the Subject m ay experience during the co urse of the

Page 15 of 40

Ex. A, Pg. 32



Study, unless such illness or injury is a Study-related injury (i.e., any illness or injury

caused by activities described in the Protocol that are different from the m edical

management the Subject would have received if he had not participated in the Study); or (f)

injuries resulting from the use of any drug (including biological m aterial) or device

supplied by any third party.

22 .2

y UCS D. UCS D shall defend, indemnify and ho ld harmless Lily, its directors, officers,

agents and em ployees ("Lilly Indemnitees") from an d against any and all claims, liabilities,

expenses (including reasonable attorneys' fees) actions or demands that may be made or

instituted against any of them b y reason of injury (including death) to any person or

damage to property, arising out of or in connection with the Study ("Claims") but only in

proportion to and to the extent such Claims are caused b y or result from the negligent or

intentional acts or omissions of, or the breach of this Agreem ent by, UC SD, its directors,

officers, agents or employees, including Clinical Investigator.

22.3

rocedures for Indemnification

2 2 .3.1 If an indemnitee becom es aware of a third-party Claim that (if successful) will

result in indemnification under this Section, the indemnitee will promptly notify

the indemnitor in w riting (with a copy of the notice to the indem nitor's legal

counsel). Failure or delay in giving suc h notice w ill not affect the right to be

indemnified except to the ex tent that it prejudices the defense of the Claim. If the

indemnitor acknow ledges that the Claim (if successful) will result in

indemnification under this Section, it may assume the defense within fifteen (15)

days after receiving the notice of the Claim. In the m eantime, the indemnitee may

take any action that it deems appropriate to protect its interests or those of the

indemnitor, provided it is not prejudicial to the indem nitor.

22 .3.2 If the indemnitor acknowledges its obligation to indemnify and assumes the

defense, it will have both the duty to d efend and the right to control the defense.

The indemnitor will conduct the defense in a prudent manner and will keep the

indemnitee reasonably informed as to the s tatus of the defense. The indemnitee

will cooperate with the defense and may retain separate counsel at its own expense

to participate in, but not control, the defense. Neither party may settle a C laim

without the consent of the other, and that consent may not be unreasonably

withheld or delayed.

2 2 .3.3 If the indemnitor does not timely assume the defense, the indemnitee will have the

right (but no duty) to defend or settle the Claim at the risk of the indemnitor. The

indemnitor w ill reimburse the indem nitee for its expenses (including reasonable

attorney's fees) of defending or settling the C laim

22 .4

ubject Injury Reimbursem ent. In addition to any amounts listed in Exhibit I, Lilly will

pay UCSD on a cost pass through basis without mark-up or overhead for any reasonable

expenses incurred in reimbursing Investigators for costs incurred related to the diagnosis

and/or treatment of an injury to a Subject directly arising from the proper adm inistration or

use of the Study Drug s or any clinical intervention or procedure provided for or required by

the Protocol to which Subjects would not have been exposed but for their participation in

the Study pursuant to the Protocol. In order for Lilly to comply w ith reporting

requirements under the Centers for Medicare and Medicaid Services (CMS) Section 111 of

the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA 111), UCSD shall

submit, upon request, documentation required by Lilly regarding any request for payment

Page 16 of 40

Dc.

A, Pg. 33



of subject injury costs. Such docum entation must be provided to Lilly prior to Lilly

making any such payment.

Section 23 Exclusion of Certain Damages

23.1

either party (nor any of its Affiliates) is required to pay, or to indemn ify any Person for,

consequential, indirect, incidental, punitive, or special damages, including loss of reven ues

and lost profits, arising from or relating to:

2 3.1.1 any breach of any provision of this Agreement, except any provision relating to

Confidential Information or Intellectual Property Rights, or

2 3.1.2 any negligence in its performance under this Agreement, except gross negligence

or intentional misconduct.

General Terms and Condit ions

Section 24 Work Plans

24.1

uring the course of the Study, the parties may develop w ritten plans designed to further

specify the responsibilities of the parties ("Work Plans") w hich may be tied to the

Statement of Work. These Work Plans will be management tools designed to improve

coordination. The Work P lans will provide additional detail regarding Services to be

performed by UCS D and Lilly as outlined in the Statement of Work. The Work Plans are

not associated with an increase to funding by Lilly and w ill not constitute a written

amendment to this Agreement unless the intention to amend is expressly stated in writing

and the W ork Plan signed by a du ly authorized representative of each party to this

Agreement.

Section 25 Taxes

25.1

ayment of Tax es. Each party w ill be responsible for its ow n taxes, including Property

Taxes on property it owns or leases, Income Taxes on its business, and any other Taxes

incurred by such party in connection w ith its business and with perform ing its obligations

hereunder. Lilly will be responsible for any Transaction Tax es properly collectible from

Lilly under Applicable Laws. UC SD w ill be responsible for payment of any Transaction

Taxes that are, under Applicable Laws, properly borne by UCSD . The calculation of Taxes

shall not include, and Lilly shall not pay, any Taxes that are related to intra-corporate

transfers or intermediate supplies of the Services betw een UC SD and its Affiliates or

betw een UCS D's Affiliates and related entities.

25 . 2

ithholding Taxes. If any payments made by the parties under this Agreement becom e

subject to w ithholding taxes under Applicable Law s of any state, federal, provincial or

foreign government, each party shall be authorized to withhold such Taxes as are required

under Applicable Laws, pay such Taxes to the appropriate Governmental Authority, and

remit the balance due to the other party net of such Taxes. The party paying the taxes to

the Governm ental Authority shall secure and deliver to the other party an official receipt

for Taxes paid.

25.3

eports Regarding A pplication of Funds. In order that Lilly may comply w ith applicable

federal tax laws and regulations, UCSD agrees that if requested by Lilly, UCSD will report

to Lilly within sixty (60) days after the close of each calendar year the dollar amoun t of

expenses which UCSD has incurred during the year but has not yet billed to Lilly on

Page

7 of 40

Ex. A, Pg. 34



activities covered by this Agreement. In order to assist UCSD in completing the statement,

Lilly will endeavor to provide UCSD with a summary of payments made to it during such

year for all Lilly studies or activities conducted by it during such yea r.

2 5 . 4

ax Docum ents and Information. Each party shall provide and make available to the other

party any ex emption certificates, resale certificates, information regarding out of state or

out of country sales or use of equipm ent, materials or Services, and any other information

reasonably requested by the other party to support the provisions of this Section 25,

including the appropriate organization of invoice formats and supporting documents.

25 . 5

ax Filings and Audits or Proceedings. Eac h party represents, warrants, and covenants that

it will file appropriate tax returns and pay ap plicable Taxes ow ed and arising from or

related to the provision of the S ervices in applicable jurisdictions.

Section 26 Independent Contractors

26.1

n performing their obligations under this Agreement, Lilly and UCSD act solely as

independent contractors. This Ag reement does not create a partnership, joint venture, or

any similar relationship between Lilly and UC SD. Neither UC SD nor Lilly has any

authority (a) to bind, incur any liability on behalf of, or otherw ise comm it the other or; (b)

to act in any other manner as agent or representative of the other.

26.2

either UCSD nor any persons employed by UCSD to perform any obligations under this

Agreem ent are employees of Lilly for any purpose. Lilly will not withhold any taxes, pay

any Social Security taxes, pay unemployment compensation, furnish worker's

compensation insurance, or provide any employment benefits for UCSD such persons.

Section 27 Delegation and Assignment

27.1

either party may assign its rights or delegate its obligations under this Agreement, except

that:

2 7 .1.1 Property rights acquired under this Agreement m ay be freely assigned unless this

Agreement expressly prohibits the assignment.

27 .1.2 A ccounts receivable may b e assigned in accordance with Applicable Law s.

2 7.1.3 UC SD m ay engage one or more Subcontractors to perform its obligations under

this Agreement, but only with Lilly's prior written consent; however, UCSD will

remain fully responsible to Lilly for the performance of all obligations delegated to

the Subco ntractor.

27.1.4 Lilly may assign any or all of its rights or delegate any or all of its obligations

under the Agreement to any of its wholly ow ned Affiliates. Lilly may assign any

or all of its rights or delegate any or all of its obligations under the Agreem ent to

any of its other Affiliates, but only with UCSD's prior written consent; however,

Lilly will remain fully responsible to UCSD for the performance of all obligations

delegated to the Affiliate.

Section 28 Regulatory Agency Visits

28.1

isitation. At Lilly's request, a representative of UCSD s hall accompany Lilly to meet

with representatives of the FDA, U.S. Environmental Protection Agency ("EPA"), or

similar domestic or foreign regulatory agencies (collectively "Reg ulatory Authority") to

explain or discuss any and all aspects of Services provided under this Ag reement. Such

Page 18 of 40

Ex. A, Pg. 35



visit or visits to the Regulatory Authority shall be arranged at times mutually agreeab le to

Lilly and UCSD. A ll reasonable travel and living expenses incurred by UC SD in

connection with such visits shall be reimbursed by Lilly.

28.2

otification. Either party shall imm ediately notify the other of any request from a

Regu latory Authority, other federal or state agencies or any other third-party to inspect or

otherwise g ain access to the information, data or m aterials pertaining to the responsibilities

assigned under this Agreem ent. Notification of such requests shall be prior to permitting

any third-party access, unless prior notice is not possible. Both parties shall have the right

to be present at and to p articipate in any such inspection or regulatory action with respect to

the Study. The contacted party shall provide the other party with c opies of all pertinent

information and documentation issued by any Regulatory Authority and any proposed

response. Both parties shall have the right to review and approve in advance any responses

that pertain to the Study.

28.3

nspection. UCS D agrees to perm it inspection of such information, data and materials by

authorized representatives of the Regulatory Authority and as otherwise required by

Applicable Law s. During such inspections, UC SD shall provide appropriate scientific and

quality assurance support for its Services and D eliverables. Lilly reserves the right to

provide additional scientific and qua lity assurance support during regulatory inspections as

related to the Services and Deliverables.

28.4

indings By Reg ulatory Authorities. UCSD w ill imm ediately notify Lilly Medical Quality

Assurance if it receives a formal report from a Reg ulatory Authority (including but not

limited to FDA- 4 83s) regarding significant findings by a Reg ulatory Authority resulting

from an inspection, review or audit of UCSD and/or any Investigators participating in

Lilly-sponsored Studies. UCSD w ill provide Lilly with its response to such finding and

Lilly shall be given the opportunity to provide assistance to UCSD in responding to any

such review, audit or inspection. UC SD shall provide Lilly with the ultimate resolution of

such findings.

Section 29

ompliance with Law, Regulations and Lilly Policies

29.1

n the performance of its Services and obligations under this Agreement, UCSD shall

comply with all Applicable Laws, regulations, and professional standards, including, but

not limited to:

29.1.1 .

• Any instructions or po licies set forth by L illy which relate to com pliance by Lilly or its

Affiliates with any US or other Government Authority mandates, settlements or

adjudications, including the Corporate Integrity Agreement (the "CIA") between Lilly

and the Office of Inspector General, US Department of Health and Human Services,

dated January 14, 2009, and any disclosure requirements set forth thereunder; UCSD

acknowledges that it or certain of its employees are deemed by Lilly to be Covered

Persons under the terms of the CIA . Supplier agrees to perform the ac tivities set forth in

Exhibit D and any other obligations required by Lilly to ensure full compliance with the

CIA."

29.1.2 Applicable clauses set forth in the U .S. Federal Acquisition Regulation ("FAR")

FAR 52.244-6(c)(I) as set forth at http://supplieroortal.lillv.com

and such other

provisions as may be required by Applicable Laws to allow the sale of Products to

the U.S. Government from time to time by Lilly; and

Page

19 of 40

Ex. A, Pg. 36



29.1.3 Paragraphs (1) through (3) of 29 C.F.R. Part 471, Appendix A to Subpart A

regarding the posting of certain notices pertaining to em ployee rights under the

National Labor Relations Act available at

lutp://www.gooaccess.gov/fr/.

29.2

otwithstanding anything in this Agreement, the parties expressly agree that the provisions

of the Uniform Computer Information Transaction Act and the United Nations convention

on Contracts for the International Sale of Goods (including any p rovision of any state law

adopting exactly, or in modified form, such laws) shall not apply to this Agreement, Work

Order, Purchase Order, Work Product, Deliverables, software services, or products

provided hereunder and that both parties waive any and all rights arising from such laws.

29.3

he parties acknowledge that each maintains its own financial authorization policies on

ensuring requisite corporate authority has been given for specific transactions. The parties

therefore agree that any communications between the employees of the parties that may

impact previously agreed upon financial, economic or legal expectations under this

Agreement, must be approved by the authorized individuals of both parties. The parties

further agree to periodically meet a nd/or enter into discussions to identify authorized

individuals as well as take any corrective actions necessary for any pa st discrepancies in

order to m eet appropriate financial expectations for potential future transactions.

29.4

ll the requirements of this Section 2 9 are in addition to all of UCSD's other obligations

under this Agreement.

Section 30 Regulatory Submissions

30.1

illy shall have responsibility for subm itting to the FDA or any other federal, state or

foreign agency all docum ents required under any applicable federal, state or foreign laws or

regulations, including annual reports and safety reports. UCSD shall provide Lilly with

relevant information for and assist Lilly in the preparation of any required documen ts,

including annual reports and safety reports and shall respond to any and all questions

regarding such reports at costs mutually agreed to by the parties in writing in advance.

30.2 mutua lly agreed upon statistical analysis plan shall be used for regulatory purposes.

Section 31

everability

31.1

f a provision of this Agreement is held to b e unenforceable, the other provisions w ill

remain in effect. If possible, the offending provision w ill be modified to the slightest

degree necessary to m ake it enforceable, remaining as close as p ossible to the parties'

original intent for the provision. If not possible, the offending provision will be stricken.

Section 32

ontract Interpretation

32.1

he meaning of a provision of this Agreement will be considered in context with other

provisions of this Agreement.

312

he following principles apply to the construction of this Agreem ent unless the

construction is plainly contrary to the intent of the parties:

32.2 .1 "Including" m eans "including but not limited to."

32.2 .2 Language that has a g enerally prevailing m eaning is given that meaning unless this

Agreement expressly assigns a different one.

Page 20 of 40

Ex. A, Pg. 37



32 .2 .3 Technical terms used in the technical field of the subject of this Agreement are

given their technical meaning.

32.2.4 Singular words may be treated as plural, and plural words may be treated as

singular.

32.2.5 The masculine gender may be treated as feminine, and the feminine gender may be

treated as masculine.

32.3

n computing any period of time under this Agreement, the day of the act, event, or default

from w hich the designated period of time begins to run is not included. If this Agreement

specifies that a period is to run for a certain number of business day s, only business days

are included in the count, and the period may not end on any other day.

Section 33

urvival

33.1

he expiration, termination or cancellation of this Agreem ent will not extinguish the rights

of either party that accrue prior to ex piration, termination or cancellation or any ob ligations

that extend bey ond termination, exp iration or cancellation, either by their inherent nature or

by their express terms.

Section 34 No Waiver

34.1

o provision of this Agreement is w aived unless the waive;is in writing and signed by the

party granting the waiver.

34.2

o delay in exercising any right, power or privilege under this Agreement will operate to

waive co mpletely or partially any present or future exercise of that right, power or

privilege.

Section 35

otice

35.1

nless specifically directed otherwise in this Agreement, whenever written notice is

required by this Agreement, it must be delivered to the applicable address indicated below

by:

35.1.1 Certified mail, postage pre-paid, return receipt requested;

35.1.2 Hand delivery;

35 .1.3 Comm ercial overnight delivery Service such as Federal Express or United Parcel

Service;

35.1.4 Email; or

35.1.5 Facsimile.

35.2

ither party may chang e its address for notices by w ritten notice to the other.

35.3

otice is effective when received. If delivery of any written notice under this Agreem ent

cannot be m ade despite the exercise of diligent efforts, the requirement to give notice is

excused.

Page 21 of 40

Ex. A, Pg. 38



Address for Notices to Lilly:

ddress for Notices to Lilly's Legal C ounsel (if

required):

Eli Lilly and Company

Lilly Corporate Center

Indianapolis, IN 462 85

Attention: Director — LRL Global Procurement

Telephone: (317) 276-2000

Address for Notices to UCSD:

8950 Villa La Jolla Drive, Ste C-2 27

La Jolla, CA 92037-1712

Alzheimer's Disease Cooperative Study

[Address]

Attention:

Telephone:

58

246-1313

Facsimile:

(858) 24 6 -1414

Email:

[email protected]

; wizzolasuesd.edu

Eli Lilly and Company

Lilly Corporate Center

Indianapolis, IN 462 85

Attention: General Counsel's Office

Address for Notices to IJCSID's Legal Coun sel (if

required):

Office of Contract and Grant Administration

95 00 Gilman Drive

La Jolla, CA 92093-0924

Attention: Rachel SievertTelephone: 858-5 34- 3335

Email: [email protected]

Nancy Bastian

Section 36 Integration and Amendments

36.1

his Agreement, its exhibits and attachments are the final, complete and exclusive

expression of all the statements, promises, terms and conditions within its scope and

supersedes any prior written or oral agreements within its scope. In making this

Agreement, neither party relies on any promise or statement made by the other party, other

than those contained in this Agreement, its exhibits or attachments.

36.2

o amendment to this Agreement will be binding on either party unless it is in writing and

signed by each party or executed in another manner expressly provided by this Agreement.

Such an amendment does not require the consent or agreement of any third party, even if

the third party is beneficiary of this Agreem ent.

36.3

n the event of a conflict betw een the provisions of the exhibits or the attachmen ts to this

Agreem ent and the provisions of this Agreem ent itself, the conflicting provision(s) of this

Agreement shall control over the language in the exhibit or attachments, unless otherwise

agreed by the parties.

Page 22

of 40

Ex. A, Pg. 39



Section 37 ignatures

37.1

his Agreement is legally binding when, but not until, each party has received from the

other a counterpart of this Agreement signed by an authorized Representative. The parties'

Representatives may sign separate, identical counterparts of this document; taken together,

they constitute one agreement. A signed counterpart may be delivered by any reasonable

means, including facsimile or other Electronic transmission.

ELI LILLY AND COMPANY

Name:

?

1

6

6

O Farrell

Title:

friiP

Date:

THE

HE REGENTS OF THE UNIVERSITY OF

CALIFORNIA; UNIVERSITY OF CALIFORNIA, SAN

DIEGO

Name:

inda Collins

Title:

irector, Office of

Contracts & Grants Admin.

Date

August 30, 2013

cf 34. Cab/

Page 23 of 40

Ex. A, Pg. 40



By signing here, I

conditions of this

)reSent that I have carefully read and understand all of the provisions and

cement and their potential impact on me,

Bv:

Name: • D r . P a u l A i s e n .

Title: °Loa cdtr

Date:

441

1



EXHIBIT B



COLLABORATIVE STUDY AGREEMENT

This Agreement by and between Toyama Chemical Co.,

Ltd.,

a company organized under the laws of Japan

("Toyama" or "Company") and The Regents of the University of California; University of California, San

Diego ("Institution") ha‘

ing a place of business at 9500 Gilman Drive, Mail Code 0687. La Jolla. California

92091-0687 is made and effective as oldie date of execution that the last party signs below (hereinafter

"Effective Date").

Background

W I IEREAS,

Institution, through the activitie, of the Alzheimer's Disease

Co()Nrative Study ("ADCS"),

established through a cooperative agreement between the

ational Institute on Aging and Institution, and

Institution's employee Dr. Paul S. A isen (

-

Principal Investigator" and Director

of

the ADCS), have experience

in conducting Multi-Center Alzheimer's Disease clinical study programs.

WHEREAS,

Company desires to collaborate with Institution to conduct a clinical study of the Drug (as defined

herein) according to a protocol and any related amendments thereto (the "Protocol") entitled "A Phase 2

multi-center, randomized. double blind, placebo-controlled. parallel group study to evaluate the efficacy

and

safety of T-81 7MA in patients with mild to moderate Alzheimer's I )isease (US202)

-

(the "Study"), attached

hereto as Exhibit "A" and incorporated herein by reference.

WHEREAS,

Company and Fujitilm Corporation are Affiliates (as defined herein) of each other and each has

rights to develop and commercialize the Drug in various regions of the world:

WHEREAS. Institution through the AD( 'S and its other resources is equipped, has the expertise, and desires to

undertake the Study in collaboration with Company, under the terms and conditions hereinafter set forth.

NOW, TIIER [WORE,

in consideration of the premises and the mutual promises and covenants expressed

herein, and for other good and valuable consideration. the sufficiency and receipt of which is hereby

acknowledged. the Parties agree as follow

s:

I.

efinitions.

A.

"Affiliate" means. with respect to either Party or other entity. any person or emits that, directly or

indirectly, controls, is controlled by or is under common control with such Party or other entity. As used

in this definition, "control" means (a) in the case of corporate entities, direct or indirect ownership of

more

than fifty percent (50''))) of the stock or shares having the right to vote for the election of directors

of such entities. and (b) in the case of non-corporate entities, the direct or indirect power to manage.

direct or cause the direction of the management and policies of the non-corporate entity or the power to

elect more than fifty percent (5(1%) of' the members of

overning, body ofsuch non-corporate entity.

For the avoidance of doubt, the Company. Fujitilm Holdings Corporation (a corporation organized

under the laws ofJapan), Fuji film Corporation (a corporation organized under the laws of Japan). and

Fuji film Pharmaceuticals U.S.A.. Inc. (a corporation organized under the law of the Commonwealth of

Massachusetts) are Affiliates of each other.

B.

"Applicable Law" or "Applicable

Laws

means any and all laws, rules, regulations, guidelines and

ethical standards including but not limited to Good Clinical Practices ("G('Ps"), and including law

s .

regulations and guidelines governing data protection and pH\ acv (including. but not limited to. the

IIIPA A. the Fitropean Union Data Protection Directive and the guidelines of the International

Conference on I larmonisation of Technical Requirements for Registration of Pharmaceuticals For

I

human ( :se

''ICI I"), and those regarding the sourcing, handling, storage, banking. transport. use,

disposal. releasing. transierring. import or export of I human Biologic Materials and associated data,

each as may be amended from time to time, and as appropriate to the pertbrmance of the Study under

Ex. B, Pg. 42



this iNgreement.

"Case Report Forms (CRF)" means the form, in electronic: or paper fonnat, which may consist of

multiple pages. and is jointly developed by Company and Institution for

the

purposes of the Study to

collect Subject data reporting.

I). "Clinical Study Results" means any and all CR Es prepared in part or in whole to record the results of

the Study and the data contained therein, deliverables under the Protocol, any results arising from the

conduct of the Protocol. compilations and analyses of the data set forth in such CREs. reporv, in respect

of the Study. including, in each case, without litnitation, written. printed, graphic, or video material, and

information contained in any computer data base or computer readable form implemented or maintained

in connection with the Study by the Institution. Principal Investigator. or

the Company in the course of

conducting the Study, and specifically excludes Institution Data and Direct Identifiers.

E.

"Company Confidential Information" has the meaning given to that term in Section 8(1).

F.

"Company Intellectual Property" means

any

Intellectual Property made in the direct performance of

the Study that is invented solely by employees. officers, agents. or other persons on behalf of Company

or other isc acquired or licensed by Company from one or more third parties.

G.

"De-Identified Human Biologic Materials" means HUIrlan Biologic Materials and associated data that

do not include the 18 identifiers of Protected Health Infomiation as

set

forth by I IIPAA in the 11 IPAA

Privacy Rule and which I Inman Biologic Materials and associated data are coded and labeled so as to be

linked to the CRLs in respect of the Subjects from whom such I luman Biologic Materials have been

obtained.

II. "Direct Identifiers" means information that directly identities a Subject, including, but not limited to.

Subject's name, birth date, street address, telephone. social security, medical record, or health plan

beneficiary numbers.

I. "Drug" means that certain drug called

-

1-81 7mA ( -1342(

I

-benzothiophen-5-y1) ethoxy

propyl ;-3-azetidinol maleate; "1-8I7) under development by Company as a pharmaceutical to treat

Aliheimer's Disease.

"Effective Date" has the meaning given to that term in the first paragraph

of

this Agreement.

K. "FDA" neamis the U.S. Food and Drug Administration and any successor thereto.

I.. "Fundamental Structural Change" means (a) when used with respect to (.'ompany, any materially

adverse change in the business, assets, liabilities, results ofoperations, condition (financial or otherwise)

or prospects of Company taken as a whole (excluding, however. changes in general economic

conditions or financial markets) or (b) when used with respect to Institution. iii any materially adverse

chance in the legal authority of Institution to perform its respective obligations under this Agreement

due to any statute, law. rule, regulation, judgment. order, decree, permit, license or injunction of any

governmental authority that is applicable to or binding upon Institution or any of its properties. ()i) any

materially adverse chance in the operations of Institution taken as whole that will jeopardize or disable

continuation of the Study. caused by compliance with any order or regulation or ally government entity

(such as the National Institute on Aging) acting lawfully within Institution's power, or (iii) any event

bey (ind the reasonable control of Institution that in the reasonable judgment of Institution acting in good

faith and after

consullinu,

with Company prevents, restricts, interferes or delays Institution from being

able to satisfy its obligations under this Agreement, provided that Institution, where reasonably possible.

has used its reasonable best efforts to avoid or remove such cause, and in each case not caused by the

negligence, intentional conduct or misconduct of Institution.

Ex. B, Pg. 43



M .

"Ilealib Authority" means the governmental agency in each jurisdiction \vhere the Study is conducted

responsible for regulating. M s uch jurisdiction the conduct of hum an clinical trials ol

.

medicinal products,

including, without limitation, the FDA.

N.

"IIIPAA" means the U.S. Health Insurance Portability and Accountability Act of {9% and any

regulations and official guidance documents promulgated thereunder, including, without limitation, the

IIPAA Privacy Rule and the HIPAA Security Rule.

0. "Illl'AA Authorization" means the authtvimtion required to be obtained pursuant to HIPA A from

Subjects pursuant to .45 CI...R. Part 164 in the U.S. Code of' Federal Reenlat ions.

P.

"Duman Biologic Materials" may include, but are not limited to. blood, urine, saliva, or other bodily

fluids. products of conception, excess pathology tissue, surgical tissue and any other human tissues.

Q.

"Informed Consent Form" means the form of informed consent agreed upon by Company and IRB

and to be signed by each Subject print to Subject's participation in the Study.

R.

"Institution Data" means source documents. Subject medical records, and raw data generated or

collected from Subjects during the performance of the Study,

S.

"Institution Intellectual Property" means any Intellectual Property discovered, conceived, reduced to

practice or developed by Institution employees (including, without limitation, the Principal

Investigator) arising from the Stud y that are neither Com pany Intellectual Property nor Joint Intellectual

Property.

T.

"Institutional Review Board" or "IBB" means the institutional review board from w Inch Institution

shaII seek approval of the Protocol and the Informed Consent Form.

U.

"Intellectual Property" means collectively inventions, discoveries. products, mechanisms, substances.

formulae, and methods, including improvements.

V.

"Joint Intellectual Property" means any Intellectual Property invented, conceived, and reduced to

practice jointly by Company and Institution employees (including. without limitation. the Principal

Investigator), as determined by U.S. Patent I ,a w , in the conduct of the Protocol or directly resulting from

the scope of the Study that is neither C ompany Intellectual Property nor Institution Intellectual Property.

W.

"Option" has the meaning given to that term in Section /it(

X.

"Party" means Institution, or Company, as applicable. and "Parties" means. collectively. Institution

and Company.

Y.

"Principal investigator" means the Institution's employee who will personally supervise the Study

and may not delegate this duty. Principal Insestigator may, however, delegate other duties to qualified

personnel in accordance with the Protocol and regulatory requirements.

Z.

"Protocol" has the meaning given to that term in the Recitals.

AA. "Samples" has the meaning given to that term in Section 5(A).

RR. "Site" means the physical locations where the Study is conducted and includes, among other locations.

hospital. outpatient, community and other clinics, and physician's offices.

Ex. B. Pg. 44



CC."Study" has the meaning given to that term in the Recitals.

1)1). Stud Stall'

means Principal Investigator and any other employee, contractor, or agent performing or

assisting with the study on behalf of the Institution,

EE. "Sub-Ins estigator" has the meaning given to that term in Section 2(C).

FE.

Subject

means each human subject participating in the Study.

GC."Subsequent Derived Intellectual Property" means any Intellectual Property directly arising from

the use of the Clinical Trial Results or Joint Intellectual Property tOr academic non-commercial research

purposes by Institution and Principal Investigator.

1111."Term" has the meaning given to that term in Section 7(A 4

2 .

erformance of Study.

A.

Compliance With This Agreement. Institution and Principal Investigator agree to perform the Study

in strict accordance with the Protocol, including any subsequent Protocol amendments thereto, all

Applicable Laws and the terms and conditions of this Agreement. In the event that Institution and/or

Principal Investigator use the services of Sub-Investigators, investigational staff. or others to conduct a

portion of the Study, Institution and Principal Investigator shall be responsible for ensuring that all are

appropriately licensed and credentialed and in compliance with the terms of this Agreement. Institution

and Principal Investigator shall refrain from, and shall cause any other member of the Study Staff to

refrain from, using the Drug in any manner that is contrary to the provisions of, or outside the scope of.

the Protocol or that is contrary to Applicable

I a W

or written instructions from Company. Institution. or

Principal Investigator, as applicable. Institution shall be liable kir any breach of this Agreement by such

individuals to the extent the breach is caused by or results from the Institution's negligent or intentional

acts or omissions.

B . R ep la ce me nt

of Principal Investigator. In the event that the Principal Investigator becomes no longer

affiliated with Institution. Institution shall designate another individual to serve as Principal Investigator

and provide written notice to Company within three (3) days of such departure and designation.

Company shall have the right to approve any new Principal Investigator designated by Institution.

Institution shall require such new Principal investigator to agree in writing to abide by the terms and

conditions of this Agreement. In the event Company does not approve such new Principal Investigator.

Company may terminate this Agreement in accordance with the Section 70.31 (Termination) below and

Institution shall comply with the provisions of Section 7(11;4v) related to such termination.

C.

Delegation of Investigator Duties.

Institution may not replace Principal Investigator or substantially

reduce Principal Investigator's role in the Study without Company's prior written approval. If

-

Principal

In\ estigator is to be temporarily absent from Institution for more than fifteen 15) business days.

Institution shall designate a sub-investigator ("Subinvestigator' 110 temporaril) supervise the Study on

the Principal Investigator's behalf and inform Company of such designation in writing at least 14 days

prior to such absence. Institution shall document this designation.

l). Audits by Company.

t I) Institution

shall make

available to Company {or its agent). to the extent allow able under Institution's

policies mid procedures, and, subject to applicable law relating to patient confidentiality. all Study

documents and Institution Data upon reasonable advance notice from Company and during regular

business hours, to allow Company (or its agent) to conduct audits from time to time to confirm that the

Study is being conducted in conformance with the Protocol and in compliance with this Agreement and

Ex. B, Pg. 45



Applicable Laws. Except as provided in Section 2(D)( 3) of this Agreement, Company shall have a right

to conduct up to three (3) audits under this Section 2(D) during the term of this Agreement.

(2) If Company determines based on any such audit, that the conduct of the Study violates or is

otherwise not in compliance with the Protocol, this Agreement, or Applicable Laws, Company shall

notify the Principal In estioator and Institution to such effect. Upon receipt of any such notice, the

Principal Investigator and Institution shall promptly act to cure any circumstances giving rise to such

violation or noncompliance. To the extent any such violation or noncompliance was the d irect result of

Institution htiling to adhere to GCP, the cure shall be at the expense of Institution. which shall be

accounted ft

-

ir as an offset against payments owed by Company" to Institution hereunder. Company shall

provide such reasonable and necessary assistance as is requested by the Principal Investigator and

Institution in order to effect such cure and shall work w ith Institution to determine how the expense shall

be covered when not the direct result of Institution faili4,

to adhere to (iCP.

(3 t Company shall have the right to conduct audits as needed for the purpose set forth in Section 2(1))(1)

above and in response to any violations or noncompliance by Institution and Principal Investigator of or

with the terms and conditions of this Agreement or the Protocol. A pre-qualification audit will he

conducted as mutually agreed to between the Parties.

E.

Inspections. Each Party acknowledges that the other ()arty may respond independently to any

regulatory correspondence or inquiry in which such Party or its A Ifiliates is named. Each Party,

however, shall notify the other Party promptly of any FDA or other governmental or regulatory

inspection or inquiry concerning any matter relating to the Study. During any such inspection or inquiry.

the Parties agree to make reasonable efforts to disclose only the information required to he disclosed.

F.

Source Documents Verification. Institution shall enter into an agreement w ith each Site pursuant to

which such Site shall be contractually required to respond promptly to any request from Company for

verification of any source documents in respect of any Subject treated at such Site in connection

With the

Study by providing to Company such documents and information as are necessary for such purpose.

3.

nstitutional Review board (IRB)- Informed Consent — Authorizations.

A.

Approvals. Institution shall be responsible for obtaining IRB approval of

-

the Protocol, the Informed

Consent Form. Study advertisements (natty), any alteration to or waiver of any subject authorization

permitting the disclosure of confidential subject information in connection with the Study

, and any

matter involving

questions of

human subject protections, from the IRI3 prior to commencement °land

during the performance of the Study.. In the event the IR1.3 requires changes in the Protocol or any

substantive and material changes in the Informed Consent Form, such changes shall not be implemented

until Company is notified and gives its written approval. The Protocol, the Informed Consent Form, and

any Study

advertisements each in their original form and prior to commencement of the Study shall be

mutually agreed upon by Institution and Company. and each shall not he rev ised without the prior

written agreement of Company and the Principal Investigator. Amendments shall be approved by the

IR R prior to implementation. Institution shall conduct the Study in a manner consistent with the

Informed Consent Form as so approved and all other applicable consents.

B.

Signed Informed Consent Forms and IIIPAA Authorizations, Institution shall be responsible for

obtaining the Informed Consent Form validly signed by or on behalf of each Subject and appropriately'

doknimented prior to the Subject's participation in the Study.

C.

Subject Medical Information. The Informed Consent Form shall include the right for Company and

its designees and applicable government authorities to review raw Study data, including original Subject

records, and all monitoring and auditing activities required to ensure quality assurance and compliance

with the Protocol as well as all legal and regulatory requirements. Company may' copy such original

Subject records and records relating to such monitoring and

auditing

activities to the extent permitted by

Ex. B, Pg. 46



the express authorization in the Informed Consent Form and HIPAA Authorization signed by each

Subject and to the extent that Company complies with all Applicable Laws regarding the confidentiality

of Subjects medical records and other health information. including. without limitation. holding each

Subject's personal identifying information in confidence.

D.

RH Letter of Approval. If requested by Company. Institution and Principal Investigator shall provide

Company with copies of the letter of approval from the IRB, the approved Informed Consent Form and

any relevant communications with the MB, which includes, but is not limited to. information which

may

affect

the conduct of the Study.

E.

HIPAA Matters. Institution represents and covenants that (a) it is a "covered entity'' under the

provisions of HIPAA. and (b) Institution shall handle all Study records and Institution Data in

accordance with HIPAA and other Applicable Law. Such compliance shall include. in each case when

required, obtaining from each Subject a HIPAA Authorintion or obtaining a waiver valid under 45

C.F.R. See. 164.512(1) that permits the disclosure and

use

of data collected from the applicable Subject

in accordance with the Protocol. Institution acknowledges that Company is not a "covered entity'' (as

defined by HIPAA ) and will not become a "business

associate"

(as defined by IIIPAA) of a covered

CiitiiV h

performing its obligations under this Agreement.

4 . Adverse Event Reporting.

Institution and Principal Investigator shall be solely responsible for complying, within the required

timelines. with any safety reporting obligations to the competent I.lealth Authorities. the Bit and the

participating (co- or sub-) investigators, as defined in the Applicable Law. Principal Investigator and

Institution also agree to notify Company within a reasonable time period as written in the Study Scope

of Work set fOrth in Nxhibit 11 attached to this Agreement. Safety Plan and the Protocol of any serious

and or unexpected adverse events (as defined in the Protocol)

at lectity

any Subject in the Study .

5 .

Transfer of Iluman Biologic Materials.

A.

Generally.

Institution shall comply with Applicable law in the collection, storage, and transfer of

any I luman Biologic Materials taken from Subjects in the perlortnance Study, and shall obtain any

informed consents required from Subjects for the use of such materials in accordance with the

Protocol and such other uses as set forth in such informed consents. During the course of the Study,

Institution will coordinate with Company to transfer the De-Identilled Human Biological Materials

taken from the Subjects in the perfiwinance of the Protocol (

-

samples-

) to a third party entity for

storage, management, and use in accordance with Section b.

B.

Reimbursement. As part

of Company's financial support of this Agreement. Company shall. in

accordance with the Reimbursement Schedule set

out

at Fixhibit C, reimburse Institution for its

reasonable and documented out-of-pocket expenses inclined

in

connection with technical and

logistical activities associated with de-identification. sourcing. handling, preparing, storing and

transferring the Samples as required under this Agreement. Institution acknowledges and agrees that

all sums paid by Company under the terms of this Agreement are solely for the performance of the

Study and the reimbursement of expenses incurred by Institution in connection with its obligations

under this Agreement. Institution certifies that:

I .

he sums payable under this Agreement represent the fair market value for the Institution's

services and expenses in the conduct of the Study; and

ii.

t has the right under Applicable Law to receive the payments contemplated under this

Agreement, and

Ex. B. Pg. 47



no sums under this Agreement are designed to compensate for the sale or purchase of

I luman Biologic klaterials; and

iv.

he Parties specificallv intend to comply with all Applicable Laws, including. without

limitation, the U.S. federal anti-kickback statute (42 U.S.C. 1320a-7b), the related sate

harbor regulations and the limitation on Certain Physician Relemds. also reterred to as the

"Stark Law" (42 U.S.C. 1395 (n)). Accordingly, no part of any consideration paid

hereunder is a prohibited payment for the recommending or arranging for the referral

of

business or the ordering

of

items or services: nor are the payments intended to induce

illegal referrals of business.

6. Permitted Uses of Inman Biologic Materials.

A.

Right to Use. Company and its officers. employees, agents or their Affiliates have the right to use the

Samples. including related data, according to the terms of this Agreement for the Study and

for

other

research, development and commercial uses that are consistent with the informed consent and

Applicable Law. Institution, its officers, agents and employees shall have the right to use any lluman

Biological Materials and Samples. including related data, according to the terms of this Agreement for

the Study and for other research. education, treatment of subjects who are participating or have

participated in the Study and related non-commercial purposes that are consistent with the informed

consents and Applicable Law,

B.

Obligations. Institution agrees to handle and maintain any Human Biologic Materials and related data

collected by Institution in accordance with the terms of this Agreement and Applicable Law. Company

agrees to handle and maintain the Samples in accordance with this Agreement and Applicable Law.

Company and Institution agree that reasonably promptly following the execution of this Agreement

they shall agree upon a set of procedures for managing the storage and use of the Human Biologic

Materials tbr purposes beyond those contemplated by the Protocol and the Study ("Post-Study

Uses"). Such procedures shall have as their purpose the optimal use and stewardship of the Human

Biologic Materials in order to satisfy the requirements of the Protocol and the Study and any Post-Study

l;ses. Such procedures shall include, among other things, periodic consultations between the Parties as

to Post-Study Use s by either Party, maintenance of an intim/1;Mo ) system containing data on the types

and quantities of I

illITIall

Biologic Materials in storage, and shall comply with all Applicable I .aws and

applicable Informed Consent Forms. Post-Study Uses shall indude Company further do, elopment and

commercial uses and shall include Institution further acadonie non-commercial research and

educational uses.

C.

Agreements with Non-Affiliated Third Parties. Subject to its obligations under Section NB). the

Parties shall fully document by a written agreement any transfer or disclosure of the {Rattan Biologic

Materials and any related data to any third party that is not an Affiliate of the Parties and to include in

any such agreement restrictions and obligations on the third party substantially- in accordance with the

obligations of this Agreement,

7. Term and Termination.

A.

Term. The term of this Agreemenu

-

Term") shall begin on the Effective Date and shall end on the later

of ti May 31, 201g, or (ii) upon Company's agreement that the milestone captioned "Completion of

CSR Res iew and signing by Principal Investigator" in Exhibit C has been satisfactorily completed and

Company's receipt of the final Study report as so signed by Principal Investigator, as required pursuant

to the Scope of Work. The Parties agree that the Term may be extended by mutual written agreement.

B.

Termination.

Ex. B. Pg. 48



1 )

otwithstanding the provisions set forth in Section 7(A) and in addition to those events described

elsewhere in this Agreement as permitting immediate termination of this Agreement, this

Agreement may be terminated by Company at any time in the exercise of its sole discretion upon

thirty (30) days prior w ritten notice to Institution and Principal Investigator.

(ii)

n addition, this Agreem ent may be term inated by either Party upon written notice to the other Party

if any of the following events occur: (a) after prior consultation w ith the other Party. the term inating

Party' reasonably believes in good faith that there are valid scientific or ethical reasons not known

before execution of this Agreement for not commencing or discontinuing, as applicable, the Study;

(b)

after prior consultation with the other Party. the terminating Party reasonably believes in good

faith that commencement or continuation, as applicable, of the Study will compromise patient

safety or result in a material v iolation of data integrity. Good C linical Practices. or Applicable Law s;

(c)

the non-terminating Party fails or is unable to remedy within thirty (30i days of prior written

notice of a material violation

or

this Agreement by the terminating Party: or td) either Party seeks

termination not earlier than one-hundred twenty (120) days follos ing prior written notice to the

non-terminating Party that a Fundamental Structural Change with respect. ni the terminating Party

will render the terminating Party unable to satisfy. its obligations under this Agreement.

(iii)

pon receipt of such notice in respect of the circumstances described in clauses (a) and (b) of

Section 7(3)(ii), the Parties agree to work together to promptly' terminate conduct of the Study. to

the extent medically permissible, for all Subjects. Upon receipt of such notice in respect of the

circumstances described in clause (c) of Section 7t 131(u). the Parties agree to continue the Study in

accordance with this Agreement until a final resolution of the relevant dispute.

(iv)

n the event of termination hereunder, other than as a result of a material breach by Institution or

Principal Investigator, the total stints payable by Company pursuant to this Agreement shall he

equitably prorated for actual work performed to the date of termination, with any unexpended funds

previously paid by Com pany

.

to Institution being refunded to UoMpany.

(s

)

lpon the termination of this Agreement by Company pursuant to Section 703)(i i)1ct or by

Institution pursuant to 7(B)(ii)(d) or following the delivery of the termination notice, as applicable,

each of the following provisions shall take effect:

(I) within thirty (30) days

of

the date of such notice, to the extern feasible. Institution shall

complete the do-identification of any Human Biologic Materials then in the possession of

Institution or any Site and deliver to Company such De-Identified I luman Biologic Materials.

and the rights of Institution (provided that prior to the liate of such notice all data from the

Study has been reviewed and all queries and issues about that data have been resolved and the

database containing that data is closed to further entries or revisions (the "Database Lock")),

Company and its Affiliates to use such De-Identilied Human Biologic Materials in accordance

with Section 6(A) shall survive termination of this Agreement, and Institution's use rights shall

continue in the event of pre-Database Lock termination to the extent it is determined. alter

consultation with Company. that the use is not ad

crse to the Study goals and objectix es:

(2 )

within ten ( 10) days of the date of such notice, to the extent feasible by Institution and the Sites,

but in no event more than thirty (30) days

or

the date of such notice. Institution and the

applicable Site shall complete and deliver to Company any and all CRIs then outstanding in

respect of any Subject;

(3 )

within thirty (30) days of the date of such notice, Institution, Principal Investigator, and any

Site shall deliver to Compan• a report of Clinical Study Results other than CRI's (which are

addressed in subclause (2) of this Section 7(111)(v));

Ex. B,

Pg. 49



(4 )

Institution shall deliver to Company, upon request. invention disclosures lot any Joint

Intellectual Property and Institution Intellectual Property conceived and reduced to practice

prior to the termination:

(5 )

the rights and obligations of Company and Fujifilm Corporation and the rights and obligations

of Institution and Principal Investigator under Section 8t l))( iii) shall survive termination or this

Agreement: neither Institution nor Principal Investigator shall thereafter use any Company

Intellectual Property for any purpose whatsoever. other than to fulfill Institution's or Principal

Investigator's obligations under Section 8(l)) iii); and w ithin ten (10) days following the

completion of any assistance from Institution and Principal Investigator requested by Company

under Section St WHO, Institution and Principal Investigator shall deli‘er to Company any and

all manifestations of Company Intellectual Property then in the possession of Institution or

Principal Investigator, as applicable;

((i) within thirty (30) days of the date of such notice, each of Institution and Principal Investigator

shall provide Company w ith copies ()fatly

and all writings that are the subject of Copyrights

referenced in Section 8(11). and the rights of Institution. Company and Fujiiihn Corporation

under Section 8111 ) shall survive termination of this Agreement:

(7 )

the rights of Company under Section 2(D) in respect of any and all Institution Data shall

survive termination of this Agreement and within thirty (30) days following the date of such

notice, Institution shall, to the extent permissible under Applicable Law and the Informed

Consent Form, deliver to Company copies of any and all Institution Data and Company shall

have the right to use the Institution Data for purposes of continuing the undertaking of the

Protocol and the Study, and any further research and development of the Drug and successor

compounds thereto:

(8)

The rights of Company and Fuji film Corporation rights under Section 8(G) in respect of any and

all Institution Intellectual Property and Section 8(C)i iv) in respect of any and all Subsequent

Derived Intellectual Property shall survive termination of this Agreement and within thirty (30)

days following the date of such notice, Institution shall, to the extent permissible under

Applicable Law, disclose any Institution Intellectual Property and Subsequent Derived

Intellectual Property to Company, and unless the Database Lock has occurred prior to the date

of such notice, from and after the date of such notice. Institution shall cease an work or further

research that involves the Clinical Study Results: and

(9 )

the rights of Institution, Company and Fuji tilm Corporation to Joint Intellectual Property under

this Agreement (including, without limitation. Section 81F)(iii)) shall survive termination of

this Agreement: and within thirty (30)days Ibllowing the date of such notice. InstitutiOn shall

deliver to Company Joint Intellectual Property disclosures.

( o) Notwithstanding the foregoing, Institution shall retain its rights to Institution Intellectual

Property, Joint Intellectual Property, and Institution Data for its ow n internal and

non-commercial research, teaching, and education purposes to the extent the parties determine

in good faith that Institution retaining its rights will not be detrimental to completing the Study.

Institution will cooperate with Company as needed to assist in transfer of the Study so it may

continue post-termination.

(11)1. Ipon completion of the above, Institution shall have

110

further obligation to Company with

respect to disclosing intellectual property, delivering results, or data and Company shall

provide institution with written confirmation that all

actions under this section have been

completed and that Institution has no further obligations to Company under this Section 7( )(v)

unless and until a separate written agreement is entered into between the Parties.

Ex. B, Pg. 50



(I 2)The Parties agree that Company, Fujitilin Corporation and their licensee:: and assignees, as

licensee or assignee of all rights under this Ag reemen t, shall retain and may fully exercise all of

such rights atter the termination.

(vi)

otw ithstanding the foregoing, the Parties shall take reasonable steps to resolve via the dispute

resolution provisions of this Agreement any conflicts prior to terminating. For the sake of clarity.

those provisions stated in Section 23 or otherwise stated to survive shall continue to have effect.

C.

Disposition of Company Confidential Information. Institution and Principal Investigator shall

account for and return to Company. or otherwise dispose of iii accordance with Company's instructions.

all Company Confidential Information upon request of Company or at the earlier of the conclusion of

the Study or termination of this Agreement.

D.

Final Accounting. Institution shall deliver to Company, by the earlier to occur 01(i) sixty (6(1) days

after Company's approval of the final study report and (ii) ninety (90) days after termination or

expiration, as applicable, of this Agreement. a final accounting of amounts due (and reasonable

supporting documentation, which requirement shall be satisfied by properly completed Case Report

forms as to completed visits by Subjects). taking into account payments made and not yet made under

the pay men

t schedule, and expenses reimbursable pursuant to Section 7(B). from one Party to the other

Party

. Undisputed amounts due shall

he paid within sixty (60) days therealler.

8. Intellectual Property, Copyright, and Confidentiality.

A. Separate Property.

Intellectual Property that either Party owned prior to the execution of this Agreement, or develops

independently of this Study and the other Party's Confidential Information, is that Party's separate

property. It is not affected by this Ag reement. N either Party has any claim to or right in such Intellectual

Property of the other Party

.

l.

Institution Data Ownership.

(it

wnership. The Institution owns all Institution Data. Company and Institution inay freely use

Institution Data in a manner consistent with such Informed Consent Form and 110.1 approval

iiS

provided fir in Section 3(A).

(ii)

Ise by Company and Fujililm Corporation. Subject to the provisions olthe preceding Section

i Company and Fujifilm Corporation shall have full, unrestricted access and use rights to any

Institution Data for lawful purpo ses (provided that all protected health information contained in the

Institution Data is either authorized to be disclosed to Company or de-identified at Company's

expense) and may make use it (inside and outside the United States) or transfer to one or more

Affiliates or third parties the Institution Data without accounting or further consideration to and

without co nsent from Ins titution or Principal Investigator pm )\ ided that such use thereof shall not

be deemed to restrict Institution's publication rights in accordance with Section 9 of this

Agreement.

Notices. Institution and the Principal Investigator shall from time to time promptly disclose to

Company any and all Company Institution Data discovered, conceived, reduced to practice, or

otherwise developed by Institution and/or Principal Investigator.

C. Clinical Study Results.

Ownership. 'Du; Clinical Study Results shall be jointly and severally owned by Company. Fujifilm

Ex. B, Pg. 51



Corporation, and Institution.

(ii)

Use by Company and Fujifilm Corporation. Subject to the provisions of this Section 8, and to

the extent allowed by law, Company and Fujifilm Corporation shall have full. unrestricted access

and unlimited use rights to any Clinical Study Results for lawful purposes (provided that all

protected health information contained in the Clinical Study Results is either authorized to be

disclosed to Company or de-identified at Company's expense) and may make use of (inside and

outside the United States) or transfer to one or more Affiliates or third parties engaged in bona tide

research, development and/or commercial activities the Clinical Study Results without accounting

or further consideration to and without consent from Institution or Principal Investigator: provided

that such use thereof shall not be deemed to restrict Institution's publication rights in accordance

with Section 9 of this Agreement.

(iii)

Use by Institution and Principal Investigator. Subject to Sections 8(C ii). 8(C)(iv) and 8(D(iii),

Institution and Principal Investigator shall have the full, unresuicled right to use the Clinical Study.

Results for the purpose of conducting academic. non-commercial research, for teaching purposes

and for treating patients.

(iv)

Subsequent Derived Intellectual Property. Any Subsequent Derived Intellectual Property

derived from the use of the Clinical Study Results shall he subject to the Option granted to

Company. Fujifilm Corporation. and their sublicensees in Section 8(C).

0

otices. Institution and Principal Investigator shall from time to time provide Company with

reasonably prompt notice ails becoming aware of the discovery. conception, reduction um practice.

development or the like of any Clinical Stud) Results and any Subsequent Derived Intellectual

Property derived from Institution's or Principal Investigator's use of any Clinical Study Results.

D.

ompany Intellectual Property.

(i)

Ownership. All right, title, and interest to any Company Intellectual Property shall be solely

owned by Company and Pujilihn Corporation.

(ii)

Any information about Company Intellectual Property shall be deemed to be Company

Confidential Information.

(iii)

Assignment by Principal Investigator and Institution; Further Assurances, Fat+ of Institution

and the Principal Investigator agrees to cooperate with Company. at Company's reasonable

expense. in preparing, filing, and prosecuting any and all patents claiming Company Inventions,

and, at the reasonable request of Company, to execute and deliver such other instruments and do

and perform such other acts and things as may be reasonably necessary or desirable tor perfecting,

and

conveying to Company ownership in and to the Company Intellectual Property as contemplated

hereby.

E. oint Intellectual Property.

(i)

Ownership. All right, title, and interest to any Joint Intellectual Property shall be

O‘Nned jointly

and severally by Company, Fujitilm Corporation, and Institution. Subject to Section 8(1i)(iv). each

owner of any Joint Intellectual Property may dispose of its rights therein without accounting or

compensation to the other co-owners .

(ii)

Notices. Each Party shall from time to time provide the other Party with reasonable prompt notice

of its becoming aware of the discovery, conception, reduction to practice. development or the like

of any joint Intellectual Property.

Ex. B, Pg. 52



iii) Patents and Further Assurances.

Company, at its expense. shall have the right to prepare. tile. and

prosecute on behalf of Company. Institution, Principal Imestigator, and any other applicable inventors

any and all patent applications claiming Joint Intellectual Property with the cooperation of Institution

and Principal Investigator, it being understood that Institution and Com pany (or Fujifilm Corporation, as

the case m ay be) are co- applicants on any such patent application. How ever, in the case that (a)

Com pany, upon request of Institution, prepares, files., and prosecutes a patent application in respect of

any such Joint Intellectual Property or ( b) Institution and Company ag ree upon the necessity of preparing,

tiling, and prosecuting any such patent application, Institution and Company shall determine hy mutual

agreement x) the P arty which shall be responsible for and shall control the preparation, tiling, and

prosecution of such patent application and the maintenance and enforcement of any patent granted in

respect thereof and (y) the allocation to Institution and Company

(or Fujitilm Corporation, as the case

may be) attic responsibilities iOr, and ex penses ol

. such actions in respect of suc h patent applications

and patents.

iv) Use by Company and Fujifilm Corporation.

Subject to the provisions of this Section 8. and to

the extent allowed by law. Company and Fujifilm Corporation shall ha

% e full, unrestricted access

and unlimited use rights to any Joint Intellectual Property for lawful purposes and may make use of

(inside and outside the United States) or transfer to o ne or mo re Affiliates or third parties ownership

and/or use of the Joint Intellectual Property without accounting or further consideration to and

without consent from Institution or Principal Investigator.

V)

se by Institution.

To the ex tent allowed by law , Institution shall have full, unrestricted access and

unlimited use rights to any Joint Intellectual Property fur lawful. non-commercial purposes and may

make use or transfer to one or more Affiliates or third parties ow nership andfor use ofJoint

Intellectual Property for lawful and non-commercial purposes without accounting to or further

consideration to and without consent from Company, provided that Institution shall obligate

transferee to comply with this Section and Institution shall remain responsible tor providing

reasonable assistance to the Company in ensuring that such transferee comply with its obligations

under this Section after such transfer.

Institution Intellectual Property; Subsequent Derived intellectual Property.

Ownership.

All right, title, and interest to any Institution Intellectual Property and Subsequent

Derived Intellectual Property t whether derived from Clinical Study Results or Institution

Intellectual Property) shall be owned by Institution.

(ii)

Notices. Institution and Principal Investigator each shall from time to time provide Company with

reasonable prompt notice outs becoming aware of the discovery, conception, reduction to practice.

developme nt or the like of any Institution Intellectual Property and Subsequen t Derived Intellectual

Property.

iii)

Patent Applications.

Institution agrees to prepare, tile, and prosecute all patent(s) on any

I list ilution Invention

and

any invention comprising Subsequent Derived Intellectual Property,

pursuant

to the request of Company, provided Company pay s all reasonable costs and expenses

directly related thereto.

G .

icense and Option.

(i)

rant of Non-Exclusive License. To

the extent legaI.Le

to do

so.

Institution shall grant to

Company and Fujitilm Corporation a royalty-free, non-exclusive, worldwide license to make or

have made, use or have used, and import or have imponed with a right to sublicense to Affiliates of

Company' and

Fujifilm Corporation and third parties objects or methods embodying Institution

Intellectual Property and Subsequent Derived Intellectual Property for purposes of the Study and

any other internal research and development programs directly relating to Drug. Further, to the

Ex. B, Pg. 53



extent legally able to do so. Institution shall grant and agrees to grant to Com pany and Fujifilin

Corporation a royalty-free, non-exclusive, world wide license to make or have m ade, use or have

used, and import

or have

imported W

ith a right to sublicense. to bona fide research. development.

and com merciali/ation third parties, Affiliates olCom pany and kn ifilm C orporation. all

Intellectual Property that necessarily and effectively use or incorporate the Drug and are conceived

and reduced to practice in the course of the work performed by Institution and Principal Investigator

under this Agreem ent. For this purpose. Institution and the Principal Investigator shall from t ime

to time prom ptly disclose to Comp any any and all Intellectual Property conceived, reduced to

practice or otherw ise

invented by Institution and/or Principal Investigator in the course ofthe work

performed

by Institution and Principal Investigator under this Agreement,

(ii)

Grant of Option.

To the extent legally able,

Institution hereby grants to Compan and Fujifilin

Corporation an exclusive option the

-

Option") to negotiate a royalty-bearing, exclusive,

worlds ide license

to make or

have made. use of

have used. sell or have

sold,

import or have

imported

with a right to sublicense to A ffiliates of

Company and Fujifilm

Corporation and third

parties engaged in bona

tide research,

development, tin,For commercial activities objects

or

methods embodying Institution Intellectual Property.. Institution's interest in

Joint Intellectual

Property and Subsequent Derived Intellectual Property for the diagnosis,

treatment, or prevention

of Al/heimer's disease and other diseases. Such Option shall be conditioned upon Company or

Fuji film Corporation paying the reasonable expenses of such patent protection including, but, not

hinned to,

preparation, filing, and prosecution.

(iii)

Term of Option.

With respect to any item of Institution Intellectual Property and Subsequent

Derived Intellectual Property in respect of which Institution has granted

the Option to Company and

Fujildni Corporation, the Option shall expire if not exercised by Company or Fujifilin Corporation

within ninety (90) day s alter receipt

or institution's notice of

iscovery. conception, reduction to

practice, or development thereof

(iv)

Negotiation of Exclusive License. Following notice to

Institution of the exercise of the O ption,

Com pany and Fujifilm C orporation (the "Toyam airuiililm P arties') and Institution, shall

negotiate

commercially reasonable terms for the

exclusive license contemplated by the Option w ithin ninety

(90) days, such terms to be embodied in a separate license agreement, and Institution shall not

commence license negotiations with any third party relating to such

Instit

ution Intellectual Property.

Institution's Interest in Joint

Intellectual Property or Subsequent Derived Intellectual Property. If

such negotiations are unsuccessful and are terminated by one side or the other, and tithe

Toyama/Fuji film Parties shall have made a written offer for such license prior to the termination of

such negotiations. then for a period of twelve months after such termination. Institution may not

grant such a license to a third party on terms which, taken as a whole, are substantially similar or

more favorab le to the third party

than those offered hr the ToyainalFujitilm

Parties in its final offer

in respect of such negotiations, without first

offering the Toyama/FLO

-

11m Parties an opportunity to

obtain the license on those similar or more favorable terms. Institution shall hold open such offer

tor the To )

arnarl'utifilin Parties lir at least sixty (60)

days.

tithe Toy amaflujifilm Parties reject

the offer or such sixty {OW day period expires bet

Ore the Toy arnaTujifilm Parties elect to obtain

such license on such terms, Institution shall have no further obligation to the ToyamalFujifilm

Parties with respect to such exclusive license.

l

or the avoidance ot doubt, the foregoing release of

obligation allows Institution to license to another com mercial entity and

the non

-

commercial nature

of Institution's future use rights shall not im pede this ability to the extent that the O ption has

expired and

the Toyama/Fuji film Parties and Institution have not successfully concluded a license

agreement.

II. Copyrights. Title to, interest in. and the right to determine the disposition of any copyrights or

copy rightable

material first authored by Principal Investigator or Institution in connection with the

performance of the Study other than contributions to any Study reports prepared for regulatory purposes

and except as provided in Section 8{..1)

), shall remain with Principal Iiisestigator and Institution or be

Ex. 8, Pg. 54



jointly and severally owned by Company, Principal Investigator and Institution, if jointly authored by

Company together with Principal Investigator and/or other Institution personnel. Institution will grant to

Company, Fujitilm Corporation and their licensees a royalty-free. non-exclusi

4 :

right and license under

such copyrights on the Clinical Study Results as owned by Principal Investigator or Institution to use,

reproduce. display, distribute, make derivative works of and perform all such copyrighted and

copyrightable materials only for all developing, marketing and promotional materials related to the

Drug prepared by

Toyama. Fujifilm Corporation and their licensees. Each ow tier of any jointly owned

copyrights or copyrightable material may dispose of its rights therein without accounting or

compensation to any other. subject to 3n irrevocable, royalty-free. non-transferable, except to a

successor in interest of Company's rights and obligations under this Agreement, non-exclusive right and

license granted to Company. Fuji film Corporation and their licensees to use, reproduce. display,

distribute, make derivative works of. and perform all such copyrighted and copyrightable materials.

Company Confidential Information. In order to carry out the Study under this .Agreement. it may be

necessary for Company to disclose to and provide Institution with certain technical or other confidential

information relating to the Study thereinafter collectively referred to as "Company Confidential

Information") which Company considers confidential and proprietary. To be deemed Company

Confidential Information for the purposes of this Agreement such information must be clearly marked

as such and if orally disclosed clearly marked as Confidential Information within thirty (30) days of

disclosure. Institution agrees to keep any Company Confidential Information

Which

comes into its

possession in strict confidence and not to disclose or otherwise use such Company Confidential

Information for any purpose other than for the performance of the Study without the prior written

consent of Company, subject to the right of Institution to publish as provided in Section 9 of this

Agreement. The definition of -

Company Confidential Information shall include (i) subject to the right of

Institution to publish as provided in Section 9 of this Agreement. the Clinical Study Results. and (ii)

unmarked information that a reasonable person in the relevant ticld would judge as confidential. The

obligations under this section shall not apply to information:

that is in the public domain as of the Effective Date or subsequently enters the public

domain through no fault of Institution, Principal Investigator or other Study Staff.

that is known as Of the Effective Date becomes know n to Institution from its Own

independent sources as evidenced by contemporaneous written records; or

that Institution receives l`rorn any third party not under obligation to keep such information

confidential.

Compelled Disclosures. In the event Institution as the recipient or any Company Confidential

Information tor any person to whom Institution has transmitted the Company Confidential Information

received by Institution hereunder) is required by law or legal process to disclose any of such Company

Confidential Information, the Institution or such receiving person. its applicable. will (i) provide

Company with prompt notice of such event so that Company may take appropriate steps, including

intervening, to protect the confidentiality of the Company Confidential Information and (ii) use

reasonable efforts to obtain assurance that confidential treatment will be accorded to the Company

Confidential Information to be disclosed.

K. The Institution, as an instrumentality of the State ofCalifOrnia. is subject to certain state regulations and

resolutions regarding access to the Institution's records, including the requirement that the Institution

make available the terms and conditions olcontracts. 'Hie actual contract agreement must be released

upon request. although portions oldie document may be withheld when redaction meets one of the legal

exemptions under the California Public Records Act. As Such, the general terms and conditions of this

Agreement will be released to the public tipon request, with prompt notification to Company of such

release. "lo the extent disclosure of other records, including the Protocol, terms of compensation and

related documents, is requested. the Institution will use reasonable efforts to provide notice to Company

Ex. B, Pg. 55



prior to disclosure and work with Company to redact material which can be withheld from disclosure, to

the extent permitted by law and at Company's request and reasonable expense. Furthermore. for the

avoidance of doubt, the Institution maintains a publicly accessible listing of all proposals and awards.

The listing includes the name of the campus, sponsor. a \

ard amount, dates, principal investigator and

co-investigators name, project ly pe, award instrument, indirect cost rate, account and fund number.

department and academic

9. Publication.

A. Multi-Center Primary Publication. The Parties, recognizing the importance of communicating the

results

of

the Study to the public and to the medical and scientific communities in an accurate and

complete manner, intend for the first publication about the results of the Study 10 include the results

from all of the Sites and for such first publication to appear in a peer-reviewed scientific journal, in

accordance with the Protocol. Accordingly, Institution has first and sole right (which shall be

irrcv (+cable for so long as Institution is not in breach of its obligations under this Ag reement) to publish

the Study results in a joint multi-center primary publication IblION‘ log com pletion or termination of the

Study and sub ject to Section 8(1). Section 8(J) and this Section 9. For purpos es of this Section 9 and the

avoidance of doubt, the term "publish

-

includes the t011ow Mg: presentation and/or submission for

presentation in a peer-reviewed scientific or medical journal of any Section, manuscript, abstract. report.

poster. presentation. or other material (each a "publication

-

) that includes: (i) an analysis of the results

of the Study: (ii) a summary of the Protocol; and/or (iii) data supporting such analysis generated by the

Study: and tiv identifying information regarding the Drug. fixcept as otherwise provided in this

Agreement, nothing in this Agreement is intended to limit Institution's ability to publish about the

results of the study .

R. Follow-II) Publications.

Institution and Company \kill

each have the right to make follow-up

publications, and the Parties will exercise good faith efforts to coordinate such publications in order to

av old duplication.

C.

Review. Company has the right to review proposed publications about the results of the Study authored

by employee of the Institution and/or members of the Study

Staff and to require I, I ) the deletion of

Company Proprietary Information and (2) postponement of the publishing of any such item for no more

than ninety (90) days in order to protect Company's intellectual property rights

or

to avoid m aterial

adverse effect on development, manufacture and marketing of the Drug by Company, Fujitilm

Corporation and their licensees. The Parties will work cooperatively to ensure the accuracy of

statements in any such publication relating to the Study.

10. Prevention of Commingling. Institution will use reasonable efforts to ensure the ('ompany's support of the

Study is not commingled with other sponsored projects andi'or other federally'

funded research projects.

I.

Compliance with Applicable Laws,

A.

Applicable Laws. Principal Investigator and Institution agree to conduct the Stud) and maintain

records and data during and atter the Term in compliance with the Protocol and

all

Applicable Law s.

B.

Privacy Laws.

i.

he Parties agree that Institution's use and disclosure of Subject health and medical

information is subject to compliance with

applicable national, state, and local privacy.. and

security laws and regulations in the jurisdictions where the Study is conducted. The

Parties, therefore,

agree

to take all reasonable steps to protect the confidentiality of any

Subject health and medical information that it has access to and comply with all such

applicable privacy

and security laws and regulations. The obligations set forth in this

Ex. B, Pg. 56



Section shall survive the termination or expiration of this Agreement.

ii.Iiistitution agrees to obtain or cause Principal Investigator to obtain 11

.

0111 each Subject

participating in the Study a validly signed Informed Consent Form and a IIIPAA

Authorization as required in Section 3(C) of this Agreement.

C.

Study Noncompliance. In the event that

any part of this Agreement is determined to violate any

Applicable I.aws. the Parties agree to negotiate in good faith revisions to the provision or provisions that

are in violation.

D.

Principal Investigator Notice.

Institution shall inform the Principal Investigator and any other key

Study Staff', that Company may collect the following personal identifying information about such

personnel: name. hospital or clinic address and phone number, and curriculum vitae, and may transfer

this information to Company's Affiliates and their respective agents worldwide for internal study

management purposes. Nonetheless. Company and its Affiliates and its agents and business partners

will apply adequate privacy safeguards to protect such information. Company tri,1 its A Itiliates and its

agents and business partners may also use and disclose personal information as required by individual

regulatory agencies or Applicable Law. Upon written request. Company will provide the Principal

Investigator and any other k.ey Study Staff with reasonable access to such individual's personal

information that is held by. Company. Such individual may also request correction

of information

that

such individual demonstrates to be inaccurate or incomplete.

F. Compliance With Third Party health Insurance Pr(4..Ira

ms. It is Institutions policy to conduct

activities in accordance with applicable state and federal laws and regulations regarding Medicare.

Medicaid, and other third party payer programs. Therefore, Institution certifie

s that:

i. To the best of Institutions knowledge. neither Institution nor any of its Affiliates providing

services pursuant to this Agreement is excluded from participation in any state or federal

healthcare program in the l .:ni ted States, as defined in 42 USC Sec t ion 1.1 20.1-

7 b( ti or the

provision of items or services for which payment may be made by a I 5. federal healthcare

program:

Institution has not contracted for the performance of any services or supplies required tbr th

performance of this Agreement xvith any employee, contractor, agent, vendor or vendor's

Affiliate. knowing that the contracting party is excluded from participation in any state or

federal healthca re program: and

No final adverse action, as defined in 42 USC Section 1320a-7e tata I ) and 42 USC Section

1320a-7iug), has occurred or is pending against Institution or its Affiliates or, to the best

knowledg,e of Institution, contractors providita:. ser‘ ices pursuant to this Agreement.

By signing this Agreement. Institution aurees to notify Company of any ilwd adverse action, discovery

of contract with an excluded entity or individual or exclusion (as described in clauses (i). (ii) and (iii) of

this Section 10(1)) within thirty (30) days of such action.

F. No Participation of Excluded/ Debarred Persons in Performance of this Agreement.

Institution

shall not employ. contract with or retain any person directly or indirectly to perform the Study under this

Agreement if such a person is

(i) excluded from a Federal health care program as outlined in Sections I I2g and

1156 or the

Social Security Act (see the Office of Inspector General of the Department of I lealth and

I Ionian Seta ices List, of Excluded Individuals/Entities at

http://www.nig.11

hs.govifraud/exelusions/exelusions_list.asp;

Ex. B, Pg. 57



(ii)

debarred by the FDA under 21 U.S.C. 335a (see the FDA Office of Regulatory Affairs

Debarment List at

http://www.fda.gov/ICECl/Enforccmcnt

Actions/FDA t)eI iruicnt Listidefault.htm; or

(iii)

excluded from contracting with the federal gt)

anment (see the Excluded Parties Listing

System at lit tps://epls.arnet.gov

Upon written request from ('ompany. Institution shall, within ten (10) day s. provide written

confirmation that it has complied with the foregoing obligation. In the

ent that Institution becomes

aware that any person identified above becomes excluded or debarred or receives notice of the threat of

an action with respect to such exclusion or debarment. Institution shall promptly provide Company with

written notice. Upon receipt of such notice, Company shall have the right to terminate this Agreement

immediately.

G. Representations and Warranties and Covenants: Conflict of Interest Obligations,

(I)

here the study binding under this Agreement is subject to professional amPor employment rules

such as conflicts of interest or ethics policies) established by Institution or a prcifessional organimtion

or other institution with which the Principal Investigator or any Sub-Investigator is affiliated.

Institution shall cause Principal Investigator and any Sub-Investigator(s) to warrant that he or she shall

comply fully- with such rules, including, as applicable. obtaining any required approval(s) prior to

initiating the Study and making any required reports relating thereto. Further, Institution and

Principal Investigator have received no offer by Company or its affiliates or agents of extra benefit

for participation in the Study, including offers to family members, Institution warrants that it has

policies and procedures with respect to conflicts of interest, and that these policies meet the applicable

FDA requirements, and will promptly report to the Company any such conflicts relating to the

Principal Investigator or any Sub-Investigator(s) duties under this Agreement. Institution will notify

Company in the event a conflict of interest prevents a Principal Investigator or Sub-Investig,ator(s)

from conducting his or her duties and responsibilities under this agreement. Institution policy

information can be tOund it Imp; "Thlink.ucsd.edu

?sponsorleoii

policies.hind

(ii)

Institution represents and warrants that it is under no agreement or obligation to any third

party and has no material conflict of interest that would prevent it from performing its

duties .ind obligations under this Agreement.

(iii)

Institution shall ensure and certifies the billow inc.:

a. Performance of this Agreement by Principal Investigator and other Study

Staff shall

not conflict with, breach. cause a default under, or result in the termination of any

contract, employment relationship, grant or funding, agreement or understanding, oral

or written, with any third party, including without limitation any noncompetition

covenant to which Principal Investigator or other Study Staff

is a party or by which

Principal Investigator or other Study Staff is hound. Neither Principal Investigator nor

Study Staff have any obligation, whether express or implied, to any third party that

would interfere with, hamper or limit its ability to perform such person's duties and

obligations under this Agreement.

I). Principal Investigator is not a federal government employee.

c. Principal Investigator is not a member of a pharmacy and therapeutics committee

CP& I ( 'ommittee") of a health plan, pharmacy benefit manager or other health care

provider or payor,

Whet

her public or Prc•

Ex. B, Pg. 58



(iv)

nstitution ;

a. shall cause the Principal Investigator to provide to Company a signed, completet form

FDA-1572 and a curriculum vitae or other statement of quail tieations showing the

education, training, and experience that qualities the Pt ineipal Investigator to lead the

clinical investigation of the Drug for the use under the Study

;

b.

shall cause. before the commencement of the Study, during the course of the Study.

and for up to one (1) year after the completion or termination of the Study. at

Company's reasonable request, the Principal Investigator and any Sub-Investigator to

disclose to Company (and afterwards to notify Company of any relevant changes to)

any financial arrangement between Company and the Principal Investigator or

Sub-Investigator, as applicable, and including any spouse or dependent child thereof

(any such person, a "clinical investigator") as to which the value (tithe compensation

could be influenced by the outcome of the Study. any significant payments of other

sorts from Company to any clinical in estigator„tny proprietary' interest in the Drug

held by any clinical investigator, or any significant equity interest in Company held by

any clinical investigator (for purposes tit this Section 10(1l)(v)(b). the terms

"significant equity interests," "proprietary interests," and "significant payment of other

sorts" shall have the meanings set out in 21 (Tit See. 54); and

r. shall comply, and shall ensure that the Principal Investigator and any sub-investigator

comply. with all applicable disclosure requirements related to conflict of interest that

are imposed by the FDA

or other regulatory or govet mental ;inthorities.

I 2. I n dem ti ifica don.

A. Institution agrees to defend, indemnify

and hold harmless Company and its directors, officers.

employees, agents and representatives (each a "Company Indemnified Party") from any loss, claim.

damage or liability of any kind ("1„iability"), which may arise from or in connection w ith (i) the

negligence or willful misconduct of any Institution Indetnnilied Party in its perliumance of its

obligations under this Agreement. except to the extent such Liability arises from a negligent act or the

intentional misconduct of Company: or (ii) any material breach by Institution of this Agreement,

including any representations

and warranties or covenant provided herein but only in proportion to and

to the extent any such Liability is caused by the negligent or intentional acts or omissions of Institution

its officers, agents or employees. Institution's obligation to defend. indemnify and hold harmless a

Company Indemnified Party is conditioned upon the Company Indemnified Party providing to

Institution with prompt notice ofany such Liability and providing all reasonable assistance to Institution

in defending against such Liability. Company shall provide reasonable assistance to Institution in

defending against such Liability. Institution agrees that it will not settle any

chilli

or admit any liability

on behalf of any Company Indemnified Party without the prior written consent of Company. which shall

not be unreasonably \killtheld or delay ed.

It. Company agrees to defend, indemnify and hold harmless Institution and its directors, officers.

employees, agents, representatives, and Sites (each an "Institution Indemnified Party") front any

Liability which may arise from or in connection with (I) the negligence or willful misconduct of any

Company Indemnified Party in its performance of its obligations under this Agreement. except to the

extent such liability arises from a negligent act or the intentional misconduct of Institution; (ii) any

personal injury (including death) to Subjects directly

arising

from the administration or use. of the Study

Drugs or any clinical intervention or procedure provided for or required by the Protocol to which Subjects

would not have been exposed but for their participation in the Study provided, that any such administration

or use of the Study Drugs is in accordance with the Protocol or ( iii) any material breach by Company of

this Agreement, including any representations and warranties or co

% enant pros idcd herein but only in

proportion to and to the extent any snch Liability is caused by the negligent or intentional acts or

Ex. B. Pg. 59



omissions of Company its officers, agents or employees. Company's obligation to defend, indemnify

and hold harmless an Institution Indemnified Party is conditioned upon the Institution Indemnified

Party providing to Company with prompt notice of any such liability and providing all reasonable

assistance to Company in defending against such Liability. Company agrees that it will not settle any

claim or admit any liability on behalf of any Institution Indemnified Party without the prior written

consent of Institution. which shall not be unreasonably withheld or delayed.

Ii.

Insurance.

Institution shall secure and maintain in lull force and effect through the performance of the Study (and

following termination of the Study to cover any claims arising from the Study) self-insurance coverage

for: (i) medical professional and/or medical malpractice liability (ii) general liability: and (iii)

workmen's compensation, each such insurance coverage in amounts appropriate to the conduct of

Institution's and Principal Investigator's business activities and the services contemplated by the Study.

14. Payment.

A. Budget and Compensation.

The compensation and fees to be paid by Company for the Study is

contained in the budget described in Exhibit C. attached hereto and incorporated by reference in this

Agreement. Payment shall be due and payable upon receipt °fan Institution invoice that is in

accordance with the schedule set forth in Exhibit C.

Total contract amount shall not exceed the prior

written consent of Company.

B.

Fair Market N'alue.

The Parties acknowledge and agree that the compensation and support provided

by Company

nstitution pursuant to this Agreement represents the fair market value t

ir Institution

and Principal Investigator's efforts under this Agreement. has been negotiated in an arms-length

transaction, and has not been determined in a manner that takes into account the volume or value of any

referrals or other business otherwise generated between Company.' on

the one hand and Institution and

Principal Investigator on the other hand.

C.

Third Party Payor Billing. Neither Institution nor Principal Investigator shall bill any third party for

any items or services furnished by Company in connection with the Studs, or any services provided to

Subjects in connection with the Study for which payment is made as pan of the Study.

15.

Independent

Contractors.

Institution and Principal Investigator are acting in the capacity of independent

contractors hereunder and not as employees or agents of Company. The Parties will make no claim against

the other for compensation, vacation pay, sick leave, retirement benefits. social security benefits, workers'

compensation, disability or unemployment benefits or employee benefits of any kind.

16. Publicity. Neither Party shall use the name, logo, or trademark of the o ther Party or its employees or

Affiliates far promotional purposes without the prior written consent of the other Party whose name, logo, or

trademark is proposed to be used.

17. Notice. Any notices given hereunder shall

e

deemed given: (i) when delivered personally; iii) one (I) day

after having been sent by

facsimile. w ith a copy sent promptly

by registered or certified mail. return receipt

requested, postage prepaid; (iii) five (5) days

aBer having

been sent by registered or certified mail, return

receipt requested, postage prepaid: or t iv) two (2)

days alter deposit with a nationally recognized overnitzht

carrier. w ith written verification of receipt. Notice shall be given to the addressees below at the respective

addresses indicated (or to such other addressee and/or address as a Party subsequently designates writing to

the other Party pursuant to this Section 16):

Toyama Chemical Co.. Ltd.

2-5, Nishishinjuku 3-chome

Ex. B, Pg. 60

4



Shinjuku-ku Tokyo 160-0023

Japan

Attention: Ilirohisa Tsuchida, Clinical Planning Group. Clinical Research

Department

Telephone: + 81-3-5381-3827

Facs imi le :

4 -

8

- 3 - 3 3 4 2 - 5 1 4 5

entail: Ill R011 ISA_TSUCLIIDAi,toyalmi-eliemical.co.jp

1'0:

NIVFRS1TY OF CALIFORNIA SAN DIEGO

. •

9500 Gilman Drive

mail Code 0934

1.,a Jol la, CA 92093-0687

States

Attention: Rachel Sievert, Esq.

Telephone: +1-858-534-3335

Facs imi le :

rsieverriOcsd.edu

18 . Force Majeure.

If the performance of this Agreement by Institution or Company is prevented. restricted,

interfered with or delayed, (either totally .

or in pail) by reason of any cause beyond the reasonable control of

either Party or both Party (such as acts of(rod, explosion, fire, disease, weather, flood, earthquake, war,

terrorism, insurrection, civil commotion, strike or other labor disturbances, riots, destruction of facilities

and/or materials, shortage of materials. failure of common carriers, or power failure). the Party so affected

shall, upon giving written notice

to

the other Party. be excused from such performance to the extent of such

prevention. restriction, interference or delay, provided that the affected Party shall use its reasonable best

efforts to a‘ oid or remove such causes of non-performance and shall continue performance with the utmost

dispatch whenever such causes are removed. For purposes of this Section, a lack of funds shall not be

considered a cause beyond the reasonable control of the Part ies.

19 . Agreement Modifications.

This Agreement and any of its Attachments or Exhibits, may not he altered,

amended or modified except by written document signed by both Parties.

2 0.

Assignment.

Company shall has e the right to assign. in whole or in part, this Avreement (i) to Fuidilm

Corporation and other Affiliates of Company upon prior written notice to Insiitution and (ii) to third parties

upon prior written consent of Institution not to be unreasonably withheld or delayed, and Company may. in

whole or in part. delegate its obligations or assign its rights under this Agreement to a contractor, provided

that Company remains liable for the pertOrmance of all such delegated obligations. In all other instances.

neither Party shall assign its rights or duties under this Agreement to another without prior written consent of

the other Party'. Any assignment or delegation of this Agreement not permitted under this Agreement shall

be null and void. Subject to the foregoing. this Agreement shall bind and inure to the beneiit of the

respect ive Part ies and their successors and assigns.

2 1. Conflict with Protocol. If

an provision of this Agreement conflicts with a pro‘ision

or

the Protocol, the

Protocol takes precedence on matters of medicine, science. and conduct of the Study. This Agreement takes

precedence in any other conflicts.

2 2 .

Waiver and Severability.

No waiver by either Party of any breach of any provision hereof shall constitute

a waiver of any other breach of that or of any other provision hereof*.

In

the event that a court of competent

jurisdiction holds any provision of this Agreement to be invalid, such holding shall have no effect on the

remaining provisions of this Agreement, and they shall continue in lull force and effect.

2 3.

Survival.

The rights and obligations of Company and Institution, which by intent or meaning have validity

beyond such termination (including. but not limited to, rights with respect to Section 5, Section O. Section 7

Ex. B. Pg. 61



(Tenn and Termination). Section 8 (Inventions. Patents, Know-flow. Copyrights. and Confidentiality).

Section 9 (Publication). Section 10 (Compliance with Applicable Law S). Section 1 I (Indemnification). and

Section 12 (Insurance) and Section 16 (Publicity) shall survive the termination of this Agreement. In

addition, any other pros ision which by its terms is stated to survive this Agreement. and .my

other provision

required to interpret and enforce the Parties' rights and obligations under this Agreement (including without

limitation Section 1 (Definitions) and Section 18 (Force Majeure) through Section 31 (Governing 1.aw )).

shall survive to the extent required for the full observation and performance of this Agreement by the

Parties.

24 .

Disclosure of Compensation. The Parties acknowledge that certain states require pharmaceutical

companies to disclose information on compensation, gifts or other remuneration provided to physicians and

other health care professionals. Company may report as required by law. or may

oluntarily disclose or

make public, information about remuneration provided under this Agreement.

25.

Headings. Headings used in this Agreement are ibr the purpose of con enience only

1 1n_ up not ;iffect the

interpretation or construction of the Agreement itself.

26.

Entire Agreement. This Agreement constitutes the entire understanding between the Parties and there are

no collateral, oral or written agreements or understandings. This Agreement supersedes any prior oral or

written agreement or understanding between the Parties.

27.

Authorized Representa(ives. Each signatory to this Agreement pers(mally represents that, such signatory

has authority to legally bind such signatory's respective Part) to this Agreement. The signatories arc not

otherwise Parties to this Agreement. except as elsewhere set forth in this Agreement.

28 .

Counterparts. This Agreement may he executed in two (2) or more counterparts. each of

WhiCh

i s deemed

an original. but all of which together constitutes one instrument.

29.

Interpretation. Unless the context of this Agreement requires otherwise, words of one gender include the

other gender: words using the singular or plural number also include the plural or singular number.

respectively: and the term "including" means "including. without limitation."

3 0.

Dispute Resolution. The Parties will work together in good faith to resolve an disputes that arise under this

Agreement. All disputes may be submitted to arbitration or mediation upon the mutual agreement of

the

Parties.

3 1 .

Governing Law, This Agreement shall be governed by, and construed and enforced in accordance with the

law olCalifornia applicable to contract made and to be performed therein without giving effect to the

principles thereof the conflict of' laws.

[Signatures folhtw on the next page.

Ex. B, Pg. 62



IN WITNESS WHEREOF,

the Parties

hereto have caused

this Agreeinein to be executed by their duly

authorized representatives.

On behalf of Toyama Chemical Co., Ltd.

Date V

4

Name

Y

S A And

0

Mole- R4 of Devejorent

pit/is:eh

On behalf

of University of California San Diego

n

ate )

t

e

d

v

i

3

Name: Lynelle Gehrke

ThlefDepartment: Associate Director, UCSD O ffice of Contract & Grant Adm inistration

1 q

Read & Agreed,

Signature

ate

t

Paul S Aisen,

Principal investigator

A itaelinif

nts:

Exhibit A: Protocol or protocol summ ary

Exhibit 13: lOtlacr Boatmen tsl,SOW

Exhibit

C: Midget

and Payment Schedule

Ex. B,

P g .

63



EXHIBIT C



Notice of Award

RESEARCH PROJECT COOPERATIVE AGREEMENT

Issue Date: 12/08/2014

Department of Health and Hum an Services

National Institutes of Health

NATIONAL INSTITUTE ON AGING

cky.rfist.,

Grant Number:

5U19AG010483-24

FAIN:

19AG010483

Principal Investigator(s):

Paul S. Aisen, MD

Project Title: Alzheimer's Disease Cooperative Study

CONTRACT & GRANT OFF ICER

UNIVERSITY OF CALIFORNIA, SAN D IEGO

OFFICE OF CONTRACT & GRANT ADMIN

9500 GILMAN DRIVE, 0934

LA JOLLA, CA 950930934

Aw ard e-mailed to:

[email protected]

Budget

Period: 12/15/2014 —

11/30/2015

Project Period: 07/01/1997 — 11 /30/2017

Dea r Business O fficial :

The National Institutes of Health hereby awards a grant in the am ount of

see

"Award Calculation" in Section land "Terms and Conditions" in Section OF

CALIFORNIA SAN DIEGO in su pport of the above referenced project. This aw ard is pursuant to

the authori ty of 42 U SC 241 31 U SC 6305 42 CFR 52 and is s ub ject to the requirements of th is

statute and regulation and of other referenced, incorporated or attached terms and c onditions.

Acc eptance of this award including the Terms and Conditions is acknowledged by the grantee

when funds are drawn down or otherwise obtained from the grant payment s ys tem.

Each publication, press release, or other document about research s upported by an NIH award

mus t include an acknowledgment of NIH award support and a disc laimer such as Research

reported in this publication was supported by the National Institute On Aging of the National

Institutes of Health under Award Number U1 9AG01 048 3. The content is s olely the responsibi l ity

of the authors and does not necessari ly represent the off icial views of the National Institutes of

Health. Prior to issuing a press release concerning the outcome of this research, please notify

the NIH awarding IC in advance to allow for coordination.

Award recipients mus t promote objectivity in research by establishing s tandards that provide a

reasonable expec tation that the design, c onduct and reporting of research funded under NIH

awards wil l be free from bias resulting from an Inves tigator's Financ ial Conflict of Interest (FC0 I),

in accordance with the 2011 revised regulation at 42 CFR Part 50 Subpart F. The Institution

shall su bm it all FC0I reports to the NIH through the eRA Com mons FC0I Module. The regulation

does not apply to Phase I Small Business Innovative Research (SBIR) and Small Business

Technology Trans fer (STTR) awards. Consult the NIH webs ite

http://drants.nihmov/orants/policv/coi/

for a link to the reg ulation and ad ditional important

information.

I f you have any questions ab out this award, please contact the individual(s) referenced in Section

IV.

Sincerely yours,

Page-1

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TRACI LAFFERTY

Grants Management

NATIONAL INSTITUTE ON AGING

Additional information follows

Page-2

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SECTION I — AWA RE

5U19AG010483-24

Award Calculation (U.S. Dollars)

Salaries and W ages

Fringe Benefits

Personnel Costs (Subtotal)

Consultant Services

Equipment

Supplies

Travel Costs

Oth er Costs

Consortium/Contractual Cost

1

ederal Direct Costs

Federal F A Costs

Approved Budget

Federal Share

TOTAL FEDERAL AW ARD AMOUNT

AMOU NT OF THIS ACTION (FEDERAL SHA RE)

SUMMARY TOTALS FOR ALL YEARS

YR

THIS AW ARD CUMULATIVE TOTALS

24

25

26

R

ecom mended future year total cos t support

sub ect to the availabil i ty of funds and

progress of the project

Fiscal Information:

CFDA Number:

3.866

EIN:

956006144A1

Document Number:

AG010483E

PMS Account Type:

(Pooled)

Fisca l Year:

015

IC

AN

015

016

017

AG 470696

Recomm ended future year total cost support, subject to the availabili ty of funds and s atisfactory

progress of the project

NIH Administrative Data:

PCC:

3CCCTNS / OC: 414P / Released: LAFFERTYT 12/04/2014

Aw ard Processed:

05108/2014 01:52:21 PM

SECTION I I — PAYMENT/HOTLINE INFORMA TION — 5U19A6010483-24

For paym ent and H HS Off ice of Inspec tor General Hotline information, see the NIH Home Page

at

http://orants.nihmov/erants/policv/awardconditions.htm

SECTION III — TERMS AND CONDITIONS — 6U19AG010483-24

This award is bas ed on the application sub mitted to, and as approved by , NIH on the above-tit led

project and is s ubject to the terms and c onditions incorporated either directly or by reference in

the following:

a. The grant program legislation and program reg ulation cited in this Notice of Award.

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b .

Conditions or

ies and expenditure of funds in other sta

equirements, s uch as

those include

L

propriations acts.

c .

45 CFR Part 74 or 45 CFR Part 92 as applicable.

d.

The NIH Grants Policy Statem ent, including addenda in effect as of the beginning date of

the budg et period.

e.

This award notice, INCLUD ING THE TERMS AND CONDITIONS CITED BELOW .

(See NIH Home Page at http://erants.nih.qov/qrants/oolicv/awardconditions.htm

for certain

references ci ted above.)

This institution is a signatory to the Fed eral Demons tration Partnership (FDP) Phas e VI

Agreement w hich requires active institutional participation in new or ongoing FD P dem onstrations

and pilots.

Carry over of an unobligated balance into the next b udget period requires Grants Managem ent

Officer prior approval.

This award is sub ject to the requirements of 2 CFR Part 25 for institutions to receive a Dun &

Bradstreet Universal Numbering Sys tem (D UNS) num ber and m aintain an ac tive registration in

the Central Contractor Registration. Should a consortium/sub award be is sued under this award,

a DU NS requirement must be included. See

http://qrants.nih.gov/qrants/policy /awardconditions.htm

for the full NIH aw ard term implem enting

this requirement and other additional information.

This award has b een ass igned the Federal Award Identif ication Number (FAIN) U1 9AG01 048 3.

Recipients must document the assigned FAIN on each consortium/subaward issued under this

award.

This award is not subject to the Transparency Act sub award and exec utive compens ation

reporting requirement of 2 CFR Part 170.

In accordance with P.L. 110-161, compliance with the NIH Public Access Policy is now

mandatory. For more information, see NOT-OD-08-033 and the Public Ac ces s w ebs ite:

http://publicaccess.nih.qov/.

Treatment of Program Income:

Additional Costs

SECTION IV — AG Special Terms and Conditions — 51.119AG010483-24

NIH is c urrently funded through a Continuing Resolution (see NIH Guide Notice NOT-OD-15 -001)

http://grants.nihmov/erants/quide/notice-f iles/NOT-OD-15-00 1.html

Therefore, NIH will issue

non-competing research g rant awards at a level below that indicated on the mos t recent Notice of

Award. Upward adjus tments to awarded levels w ill be cons idered after our FY 201 5

appropriations are enacted; NIH ex pects institutions to m onitor their expenditures carefully during

this period.

This award includes funds awarded for cons ortium ac tivity with the University of Pennsy lvania,

Seattle Institute for Biomedical and Clinical Research, Columbia University, Regents of the

University of California, Indiana University, New York University School of Medicine, Banner

Alzheimer's Institute, Mayo Clinic, the U niversity of Rochester, W ashington U niversity, Mount

Sinai School of Medicine, University of Southern California, The Brigham and W omen's Hospital,

Georgetown University, University of California - San Francisco, Cas e W estern Reserve

University School Of Medicine and W ake Forest University Health Sciences. Cons ortiums are to

be es tablished and adm inistered as desc ribed in the NIH Grants Policy Statement (NIH GPS).

The referenced sec tion of the NIH Grants Policy Statement, October 201 0 is available at:

http://odoerdb2.od.nih.gov/gmac/nihgps_2010/nihgps_ch15.htm

Page-4

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The requested budget

onsidered and determined not to represr

i ficant re-budgeting.

Therefore, categorical

nts reflect the direct and facilities and adi.

ative cost (F&A)

levels previously recomm ended for the current year. Funds m ay b e re-budgeted between direct

cos ts and FM c osts, c onsistent wi th applicab le cost pr inc iples and inst i tu tional and pol icy

requiremen ts for prior approval.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable

U.S. Off ice of Management and Budget (OMB) adm inistrative guidelines, U.S. D epartment of

Health and Human Services (DHHS) g rant administration regulations at 45 CFR Parts 74 and 92

(Part 92 is applicable when State and local Governments are eligible to apply), and other HHS,

PHS, and NIH grant adm inistration policies.

For additional information concerning the RFA, please refer to:

http://grants.nih.gov/grants/guide/rfa-files/RFA

-AG -13 -001.html

The adm inistrative and funding instrument used for this program wil l be the cooperative

agreement, an ass istance mec hanism (rather than an acquisition mec hanism), in which

sub stantial NIH programm atic involvement w ith the awardees is anticipated during the

performance of the activities. U nder the c ooperative agreement, the NIH purpose is to s upport

and s timulate the recipients' ac tivities by involvement in and otherwise working jointly w ith the

award recipients in a partnership role; it is not to assume direction, prime responsibility, or a

dominant role in the activities. Consis tent with this c oncept, the dom inant role and prime

responsibi l ity resides with the awardees for the project as a whole, although spec ific tasks and

activities may be shared am ong the awardees and the NIH as defined below.

The PD (s)/P1(s) w ill have the primary respons ibi li ty for

Overall managem ent of the study through the c oordinating center and should ag ree to work

cooperatively with the cores/functions and c linical sites developing and implementing s ys tems

neces sary for comm unications am ong the various s tudy organizational components. The

coordinating center will facilitate the design and refinement of all protocols, manuals of

operations, and forms. All data and s amples that s hall be placed in the public domain and s hared

freely by methods and within time periods to be s pecif ied by the Steering Comm ittee, as a

fundamental purpose of this s tudy is the es tablishment of an unrestricted public databas e.

Awardees wil l retain custody of and have primary rights to the data and software developed under

these awards , subject to Government rights of acces s c onsistent with current DHH S, PHS, and

NIH policies.

NIH staff have subs tantial programm atic involvement that is above and b eyond the normal

stewards hip role in awards, as desc ribed below:

The des ignated NIA Project Scientist, Laurie Ryan, PhD , wil l serve as a mem ber of the Steering

Committee and have sub stantial scientific/programm atic involvement during c onduct of this

cooperative agreement, through technical as sistanc e, advice, and c oordination above and

bey ond normal program stew ardship of grants. The awardee agrees to accept as sistanc e from

the designated NIA Project Scientist. This person will participate, through the Steering

Committee, in the monitoring of issues relating to recruitment, follow-up, and adherence to

protocols and wil l assist in the development and/or adjustment of study protocols.

Additionally, an agency program official or NIA Program Officer, Nina Silverberg, PhD, will be

responsible for the normal scientific and programmatic s tewardship of the award and wil l be

named in the award notice.

Areas of Joint Respons ibi li ty include:

The Steering Com mittee, comprised of the PD (s)/P1(s) of the c ooperative agreem ent, the leaders

of the cores/functions and each of the clinical sites, the bioethicist, the family representative, the

FDA representative, and the NIA Project Scientist will have primary responsibility for finalizing

standard definitions, procedures, and meas ures c omm on for all the protocols. The s teering

comm ittee wil l meet every three to six m onths, or as dictated by the needs of the study . Each full

mem ber of the Steering Com mittee wil l have one vote, and all major scientific dec isions w ill be

determined by majority vote of the Steering Committee. Awardee m emb ers of the Steering

Committee wil l be required to ac cept and implement policies approved by the Steering

Committee. Subcom mittees appointed by the Steering Committee, com prised of appropriate s taff

Page-5

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NIJI

NGAR J Veniun: I •051082014 13:52:00: Gencratcd on: 12/8/2314 12:2S SS AM



from the cores and c11

tes, will be involved in the design of prot

nd manuals of

operations, and in ong,

unctions of the study s uch as preparation

blications.

To oversee the allocation and distribution of biological spec imens generated from the study , the

Steering Com mittee wil l nominate mem bers for the Res ource Allocation Review Comm ittee

(RARC). This group will review applications for use of the biological specimens. The format of the

application and c riteria for the use of repository biological s pecimens wil l be developed by the

RARC with advice and approval from the Steering Committee and made available to all potential

users . Memb ership on this c omm ittee w ill rotate periodically ac cording to a procedure developed

by the RARC. Final approval of members of the RARC and final approval for disposition of

sam ples to investigators following RARC review w ill be m ade b y NIA staff. The primary g overning

body of the study wil l be the Steering Com mittee, which wil l have responsibi l ity for the f inal details

of study des ign and policy decisions and wil l define the rules regarding acces s to data and

samples.

Dispute Res olution:

Any d isagreements that may arise in scientific or programm atic matters (within the scope of the

award) between aw ard recipients and the NIH may be brought to Dispute Resolution. A Dispute

Resolution Panel composed of three mem bers w il l be c onvened. I t will have three memb ers: a

designee of the Steering Comm ittee c hosen w ithout NIH staff voting, one NIH d esignee, and a

third des ignee with expertise in the relevant area who is chos en by the other two; in the case of

individual disagreement, the f irst mem ber may be c hosen by the individual awardee. This spec ial

dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is

otherwise appealable in acc ordance with PHS regulation 42 CFR Part 50, Subpart D and DHH S

regulation 45 CFR Part 1 6.

STAFF CONTACTS

The Grants M anagem ent Specialist is respons ible for the negotiation, award and a dministration of

this project and for interpretation of Grants Administration policies and provisions. The Program

Official is responsible for the scientific, programmatic and technical aspec ts of this project. These

individuals work together in overall project administration. Prior approval requests (signed by an

Authorized Organizational Representative) s hould be sub mitted in w riting to the Grants

Managem ent Specialist. Requests m ay be m ade via e-mail.

Grants Managem ent Specialist: John Bladen

Email: [email protected]

Phone: 301-496-1472 Fax: 301 -402-3672

Program Official: Nina B. Silverberg

Email: si lverbergn@ mail.nih.gov

Phone: 301-496-9350 Fax: 301-496-1494

STAFF CONTACTS

The Grants M anagem ent Specialist is respons ible for the negotiation, award and adm inistration of

this project and for interpretation of Grants Administration policies and provisions. The Program

Official is res ponsible for the scientific, programmatic and technical as pects of this project. Thes e

individuals work together in overall project administration. Prior approval requests (signed by an

Authorized Organizational Representative) should be submitted in writing to the Grants

Management Specia list . Requests m ay be m ade via e-mai l.

Grants Management Specialist John Bladen

Email: bladenj@ nia.nih.gov

Phone: 301-496-1472 Fax : 301 -402-3672

Program Official: Nina B. Silverberg

Email: si lverbergn@m ail.nih.gov

Phone: 301-496-9350 Fax : 301-496-1494

SPREADSHEET SUMMARY

GRANT NUMBER: 5U19AG010483-24

INSTITUTION: U NIVERSITY OF CALIFORNIA SAN DIEGO

Page-6

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14 32 2&34 AM



Budget

Year 24

Year 25

Year26 H

Salaries and W ages

Fringe Benefits

I

Personnel Costs (Subtotal)

Consultant Services

I

I

I

1

Equipment

Supplies

Travel Costs

Other Costs

Consortium/Contractual Cos t

I

TOTAL FEDERAL DC

TOTAL FEDERAL F&A

I

OTAL COST

Facil i ties and Administrative Cos ts

Year 24

Year 25 Year 26

F&A Cost Rate 1

I

I

I

I

I

I

I

I

I

F&A Cost Base 1

F&A Costs 1

Page-7

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alzheirnes

95

association

December 12, 2014

EVISED

Paul S. Aisen, MD

University of California, San Diego

Alzheimer's Disease Cooperative Study

9500 Gilman Drive, Dept 0934

M/C 0949

San Diego, CA 92093-0934

Re: Longitudinal Evaluation of Am yloid R isk and N eurodegeneration (LEA RN)

Dear Dr. Aisen:

The Alzheimer's Association is pleased to inform you that LEARN- 15 -3387 30, "Longitudinal

Evaluation of Amyloid Risk and Neurodegeneration (ADCS)" has been funded. The funding

of

LEARN

comprises three project awards: (1)

Dr. Aisen as listed in this letter (2) LEARN-15-338729, Reisa Sperling, MD.,

Massachusetts General Hospital and (3) LEARN-15 -35 2131, Cohn

L. Masters, MD., Morey Institute of Neuroscience

and Mental H ealth.

The Project will be funded beginning October 1, 2014 .

The Project period is October I, 2 014 to Septem ber 30, 2018.

The total amount of the funding is $7,004 ,76 1.00."

a)Amount

of Funding:

The Association w ill provide University of California, San Diego directly

with funding for the Project, over a period of four (4) years, in the bi -

annual

amount set forward in the project budget.

Payment for the first year (Fall 2014) is guaranteed. Payment for the subsequent years (2015 , 2016, 2 017, 2 018) will

be forthcoming unless the Association advises University of California, San

Diego in w riting by January I' of the

year in which the payment is due, that it has elected to not continue such funding. Ab sent the Association's election to

discontinue funding, the payments will be made accordingly.

Payment Cycle Funding Period Anticipated Budget

I

Fall, 2014 (FY15)

$

86,452

2

Spring, 2015 (FY15)

$

86,452

3

Fall, 2015 (FY 16)

$

71,541

4

Spring, 2016 (FY16)

$

71,541

5

Fall, 2016 (FYI7 )

$ 71,972

6 Spring, 2017 (FY17)

$

71,971

7 Fall, 2017 (FY18)

$ 72 ,416

8

Spring 2018 (FY18) $ 72 ,416

TOTAL

$ 7,004,761

The requirements for this Project are detailed in this document which includes the Award Letter,

Conditions of Award and the Patent Policy as one document. The document must be signed, initialed

where required and uploaded to your online file as a "pdr.

Ex. C, Pg. 71



alzheimer's

93

association'

The Alzheimer's Association also requires the following electronic files to be uploaded to pcCentral at:

httos://Promarentral.altum,com/loainam

•

Signed/initialed Award Letter, Conditions of Award and Patent Policy documentation as a "pd?'

•

A 5" x 7" black and white or color photograph of you in your lab

•

A non-technical abstract of the project as a Word document or "pdf'

All of the above are required and must be submitted electronically to activate the funding.

Hard copies of the

required documents

will not be accepted.

The Alzheimer's Association depends upon private support to meet its goals and to fund research projects. Therefore,

your help and support are very important in the efforts to educate the general public and the scientific community

about the disease and the Association. In accepting this research award, you agree to credit the Alzheimer's

Association for providing funds for this research whenever you present the research or publish Articles about the

project. In addition, your acceptance allows the Alzheimer's Association to use your likeness in presenting your

findings through press releasei, interviews, or other strategic activities. Please note the attached Conditions of Award

for details of this commitment.

It is necessary for both you and a representative from the business office or Office of Sponsored Research from the

applicant Institution, to sign the form below. The signatures verify that the funding is accepted by the Institution with

the attendant requirements and that no part of this research project has been funded from another source. Also,

complete the included form requesting the information for the business official that has fiscal responsibility for this

project.

Please retain a cope

for your

111eA and upload the complete Award Letter, Conditions of Award, and

Patent Polk

,

document to the ocCentral site.

Thank you for your support of the Alzheimer's Association and commitment to research on Alzheimer's disease. If

you have any questions, please call Mary Grilli, Post Award Specialist, Medical and Scientific Relations department at

(312) 335-5727.

Sincerely,

&W/4924

Heather NI, Snyder, PhD.

Director

Alzheimer's Association

Medical & Scientific Relations

Sincerely,

--

)71,24..;-. C.

Cott...zee

Maria C. Carrillo, PhD.

Vice President

Alzheimer's Association

Medical & Scientific Relations

cc:

Deborah Tobias, Director of Administraton, Signing Official

Ex. C, Pg. 72



alzheintes

c o

association '

This FY2015 Research Award is accepted on behalf of University of California, San Diego. The

requirements as specified in the Award L etter documentation

receiving duplicate funding from another source.

The Alzheimer's Association depends on volunteers for its

could not have been funded without the hard w ork of those

want to repay those volunteers by r

ining an active reviewer

respond when called upon to con

e to this support of

are accepted. o part of this project is

exem plary grant review process.

Your grant

volunteers. The Association assumes you

in our system.

It is imperative that you

the Alzheimer's research community.

By signing this document you a gr i

of the above terms and conditions.

Principal Investigator Date 2 hrbq

Institutional Official

Date

will

Ex. C, Pg. 73



alzheimer's

93 association

Conditions of Award I 09/14 (LEARN)

DATA SHARING & GAAIN

The Alzheimer's Association is committed to data sharing for Alzheimer's Association

International Research Grant Program grantees. Data sharing is a necessary means to advance

Alzheimer research results into systemic knowledge, usable products, and research procedures,

leading to the overall improvement of human health. We expect the timely release and the

sharing of final research data from Alzheimer's Association funded research studies at no more

than incremental cost and within reasonable time frame. Included in the "final research data"

are the data, samples, physical conditions and other supporting materials created or gathered

during the course of the work. The rights and privacy of people who participate in Alzheimer's

Association — sponsored research must be protected at all times. When applicable, data

collected during these stud ies and shared for broader use should b e free of identifiers and

variables related to individual subjects.

To that end, the Alzheimer's Association requires the data sharing associated with this grant

award b e connected through the Global Alzheimer's Association Interactive Network

(GAAIN). GAAIN is a federated research repository utilizing a cloud-based, grid network

infrastructure spanning centralized computational facilities in North America and Europe.

GAAIN is led and m anaged by the Alzheimer's Association, Dr. Arthur Toga (USC) and D r.

Giovanni Frisoni (University of Geneva).

Awardees are encouraged to discuss potential impediments or time delays to data sharing with

their Association contact at the time they negotiate grant agreement to accept the Alzheimer's

Association g rant award.

**IMPORTANT NOTE**

Failure to comply with the Alzheimer's Association Data Sharing Policy will result in

termination of the grant funding from the Alzheimer's Association.

5

nitial that you accept the terms stated on this page'

.

Ex. C, Pg. 74



alzheimes

9 5

association -

Conditions ofAw ard — 09/14 (LEA RN)

NOTIFICATION OF PUBLICATIONS

One electronic copy of manuscripts and meeting abstracts reporting research acknowledging

funds from the Alzheimer's Association must be submitted

ELECTRONICALLY

at the time

of publication. This copy will become part of the official file of the grant and will be provided

to the Communications Division to assist in the efforts to further inform the public about the

research program of the Association. These submissions must be made electronically using the

same system outlined above for report submissions.

The Association will provide publicity assistance when the principal investigator notifies the

staff prior to the release of findings in any scientific journal or major meeting presentations and

will work with the Public Relations Officer of the institution to ensure coordination of efforts.

Please contact the Communications Division, Media Relations Department at 312-335-5776 as

early as possible in the process, for instance as soon as the manuscript is accepted for

publication or presentation.

An acknowledgment of support provided by the Association must be included in any responses

to or interviews with radio, television or print journalists when an Association funded grant is

discussed.

ACKNOWLEDGEMENT OF FUNDING SOURCE

An acknowledgment of support provided by the Alzheimer's Association must appear in

publications of any material whether copyrighted or not, if the data is based on or developed

under Association-supported projects. The following wording should be used:

This work was

supported by A nds from the Alzheim er's Association (LEA RN -I5-??????).

In addition, an acknowledgement of support provided by the Alzheimer's Association must

appear in presentations of any material, if the data is based on or developed under Association-

supported PROJECTS.

Whenever the principal investigator is informed of sponsorship through the generosity of a

donor, the specific PROJECT name should be used. For example, the Alzheimer's

Association/Samuel A. Blank Research Grant.

**IMPORTANT NOTE**

Upon completion of projects, the Association encourages award recipients to consider

submitting an article describing results to Alzheimer's & Dementia: The Journal of the

Alzheimer's Association. For submission information, visit

www.elsevier.com/authors.

6

nitial that you accept the terms stated on this page

Ex C, Pg. 75



alzheimer's

Q s

association

Condiiions

of

Award— 09/14 ILEA RN)

RIGH T TO AUDIT

n

accordance with generally accepted accounting principles, the grantee institution ("Grantee")

shall maintain reasonably full and complete records of the cost and completion of services

performed under this Grant Aw ard and the Conditions of Award A greement (together,

"Agreements"). During the term of the Agreements, and for a period of two years after their

termination or completion, the Alzheimer's Association shall have the right to inspect and/or

audit the Grantee's records as they pertain to the performance of the Agreements at Grantee's

office. Upon five business days written notice from the Alzheimer's Association, Grantee

agrees to make available all records for inspection or audit at its offices during normal business

hours (Monday through Friday, 8 a.m. - 5 p.m. local time).

** IMPORTANT NOTE**

Overlapping finding of more than one Alzheimer's Association grant is not allowed, except in

instances of Special Grant opportunities as designed by Alzheimer's Association staff.

Investigators who currently have an active Association grant may apply for another award in

the last year of their grant if that last year conc ludes by June 30

t h

prior to the start of the new

funding year as ofJulyl.

7

nitial that you accept the terms stated on this page'

Ex. C, Pg. 76



alzbeimes

q s

association

Condit ions ofAward

- 09/14 LEARN )

REQUESTS FOR ADMINISTRATIVE ACTIONS

Subm it requests for adm inistrat ive a ct ions electronical ly through the proposalCEN TR AL

online system used for Interim and Final report subm issions des cribed above). When

the

request has been uploaded , please advise M ary Gri l li , Post Award G rant Special ist that a

request has been fi led (MamGrilliealz.org

).

** IMPORTANT NOTE**

' ALL letters and reports must be submitted electronically (see instructions above in

reporting requirements).

Requests for administrative actions (e.g. re-budgeting, carry-over of unexpended funds,

replacement of principal investigator, transfer of institution, overlap, extension of award,

administrative supplements)

must be submitted electronically via letter

which has been

signed by the principal investigator of the application or grant and the responsible, bonded

business official of the institution. Any request must be submitted 45 days prior to the desired

date of action. Association staff will review draft letters for content and appropriateness prior to

submission of the final signed request. The preliminary review does not indicate advance

approval of the request, rather the preliminary review will ensure that all necessary information

has been included.

Review and approval of requests for administrative actions is the responsibility of the staff of

the Alzheimer's Association. The Association reserves the right to refer a request to the MSAC

for its advice prior to final decision. All requests for adm inistrative supplemental funds w ill be

referred to the MSAC.

Re-budget ing

Requests for re-budgeting of m ore than 10% of the total awarded amount (direct + indirect

costs) for that year

must be submitted electronically

for prior approval to the Alzheimer's

Association. Requests to re-budget must be clearly explained and justified against the timely

achievement of the specific aims of the grant. If possible, re-budgeting requests should be

submitted w ith the interim/non-competing continuation report. If necessary, re-budgeting

requests will be accepted mid-grant year.

Carry over of Unexpended Funds

In general, permission to carry forward unexpended balances into future funding years is

allowed. For exam ple, a $10,000 unexpended balance at the end of the 02 year, of a three year

award, will be carried forward automatically and used to supplement to the $60,000

continuation funding of the 03 year (which would provide the investigator a total of 0,000 for

the 03 year).

Initial that you accept the terms stated on this page

Ex C, Pg. 77



alzheimer's 9 5 association

Condit ions

of Award-09/14 LEARN)

Replacement of the Principal Investigator

The grantee institution may request the replacement of a principal investigator, except for

principal investigators of Zenith and Pioneer awards. If the principal investigator of a Zenith or

Pioneer award does not wish to complete the grant or leaves research work for some reason, the

grant will be terminated and the remaining funds returned to the Alzheimer's Association.

The request to replace a principal investigator must be submitted electronically (see

instructions above in reporting requirements) by the appropriate faculty mem ber (usually

the Department Chair or Dean) and countersigned by the responsible business official of the

grantee institution. The letter requesting replacement of the principal investigator must contain

a curriculum vita of the proposed replacement principal investigator. Approval of a

replacement principal investigator is the responsibility of the Association and subject to review

by staff.

Transfer of Institution

The Association will consider and approve requests to transfer a grant to another institution

when the principal investigator moves during the award period. The key points in determining

if a request to transfer w ill be approved are (I) if the resources and technical personnel at t he

new institution will adequately support the research through the remaining period of the award

and (2) if both institutions and the principal investigator are in agreement about the

appropriateness of the transfer.

To transfer a grant to a new institution, the following documents are required:

• A release letter from the current institution

• An acceptance letter from the new institution stating their new position and the resources

available to support the Alzheimer's Association funded research

•

A scientific and financial report detailing accomplishments to the date of transfer

• Transfer of all unexpended funds must be m ade back to the A lzheimer's Association, w ho

will in turn make a payment of unexpended funds to the new institution

The request to transfer a grant should be submitted electronically at least 60 days in advance of

the planned move to ensure Association staff have adequate time to review the request and ask

for and receive additional information should it be necessary. You may request a six-month

extension to complete work proposed in the grant for time loss during your move to the new

institution.

Overlap with other Funded Applications

Investigators must inform the Association of any overlap, or concern about possible overlap,

with other grants. Overlap is defined as "tw o or m ore grants by the same principal investigator

which share at least one specific aim". It is not necessary to provide information about

applications that share specific aims with an Association grant. The concern about overlap

arises only when an investigator has been notified that he/she will be awarded a gran

9 nitial that you accept the terms

stated on this page

Ex. C, Pg. 78



alzheinier's c o

association

Condit ions of

Award —

09/14 LEARN

another organization and that application, soon to be awarded, shares specific aim(s) with a

grant from the Association.

Extension of Award

An extension of the term of a g rant without funds (no-cost extension) or with funds remaining

at the end of the grant period (extension w ith cost) may be approved w hen requested

electronically 45 days prior to the grant expiration. Typically, requests range from six to

twelve months however you are allowed a 6 month extension for each year of the award (e.g. a

two year aw ard will be eligible for 2 no-cost extensions, up to 6 m onths each whereas a three

year award w ill be eligible for 3 no-cost extensions, up to 6 months each). The principal

investigator and responsible business official must countersign the letter requesting the

extension, whether the extension is with funds unexpended at the end of the g rant period or at

no cost. Although requests may not be made for the sole purpose of spending remaining funds,

you may expend remaining funds during the no-cost extension period. The duration of the

extension and the expected products/accomplishments must be detailed in the letter. An

extension of term m ay only be requested to complete w ork proposed in the grant.

Administrative Supplemental Awards

The Association, through review and recommendation of the MSAC , may provide

administrative supplemental funds during the period of an ongoing grant. Requests for

administrative supplements will be approved only in rare, compelling circumstances. Funds for

the award of an administrative supplement m ust be taken from the pool of funds for new

competitive grant awards.

Administrative supplemental awards m ay only be requested to (1) address some em ergency that

imperils the completion of the grant as approved and funded and (2) cannot be handled by re-

budgeting available funds. Supplemental funds may not be requested to expand the goals or

scope of the award. Investigators should contact the staff of the Grants Operations office to

thoroughly discuss the circumstances and the possible request for an administrative supplement

prior to submitting the letter.

Investigators w hose requests for administrative supplements are denied by the MSAC may not

appeal the decision.

Change of Names and A ddresses

If an investigator moves while an application is under review by the Association, it is necessary

to submit electronic notification of the new address and the date of the move by updating the PI

profile in proposalCENTRAL. In some instances, great difficulty has been encountered trying

to find an investigator to inform him/her of the award of a grant.

If the business official responsible for the grant or application at the institution is changed, the

investigator and new business official should update information electronically in the

proposalCENT RAL profile as soon as possible.

10


Ex C, Pg. 79



alzheimes association

-

Conditions

of Award—

09/14 LEARN)

Prompt online notification through proposalCENTRAL, of changes in names, titles,

addresses, phone and fax numbers, email addresses will help to avoid delays in processing

any actions or requests.

Other Administrative Actions

For other

administrative actions not covered in this document,

the investigator should submit an

electronic letter detailing the request and the rationale.

** IMPORTANT NOTE**

ALL letters and reports must be submitted electronically (see instructions above in

reporting requirements).

11


Ex. C, Pg. 80



alzheimer's

2 5

association°

PATENT POLICY OF TH E ALZHEIMER'S ASSOCIATION®

The primary purpose of the Alzheimer's Association (the "Association") funding scientifically meritorious research

is to advance its mission to eliminate Alzheimer's disease through the advancement of research; to provide and

enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health.

The Association recognizes that patentable Inventions (defined below) having pub lic health, scientific, business or

comm ercial application or value m ay be m ade in the course of research supported by the A ssociation. It is the

desire of the Association that such Inventions w ill be administered in such a m anner that they are brought into

public use at the earliest possible time. The A ssociation recognizes that this may be b est accomplished through the

filing of applications for registration of patents and/or copyrights in such Inventions and the com mercial licensing

of such Inventions to third parties. Discoveries, works of authorship, or Inventions derived from research

performed, supervised or subcontracted for by the grantee institution during the term of the grant w ill be subject to

the Association's Patent Policy as set forth b elow:

1.

"Invention" is any discovery, data, m aterial, method, process, device, product, prog ram, softw are,

proprietary know- how or other work of authorship, whether or not patentable or copyrightable, that is

created, conceived or discovered in the course of research supported in whole or in part by the Association,

and in the case of patentable inventions is capab le of being reduced to practice, either actually or

constructively, during the course of the research.

2 .

All notices of disclosure of Invention patents must be reported in a timely m anner to the Medical &

Scientific Relations Division of the Association. Upon the Association's request, all documentation

relating to the filing or assertion of rights shall b e provided to the A ssociation. The Association shall agree

to m aintain the confidentiality of such documentation by executing a confidentiality agreement mutually

agreed to by the g rantee institution /inventor and the Association. All expenses of the Invention patent

process should be b orne by the grantee institution or individual awardee.

3.

Unless otherwise indicated or requested by the grantee institution, title to any invention shall reside in the

grantee institution.

4.

Distribution of income derived from an Invention shall be according to the policies of the g rantee

institution, except that the Association shall participate in net income derived from the Invention (unless

waived in w riting by the Association) to the extent, and at a rate of remuneration, to be determined by

mutual agreement betw een the grantee institution and the Association at the time a patent application is

filed. If the grantee institution has no established and applicable patent, intellectual property, or technology

transfer policy and procedure for administering Inventions, the Association shall have the sole right to

determine the disposition of the Invention rights in a m anner consistent w ith this Patent Policy.

5. The grantee institution shall use reasonable efforts to notify the Research Department of the Association

prior to abandoning a patent or patent application claiming an invention supported by finds furnished by

the A ssociation.


Ex. C, Pg. 81



alzheiTner's

93

association®

6.

The grantee institution shall agree that if it has not taken effective steps, within a reasonable time frame for

the research project advancement after a U.S. patent issues on an Invention supported by Association funds

and administered by the institution, to bring that invention to the point of practical application, or has not

made such Invention available for licensing, the Association shall have the right to request grantee

institution terminate the license for lack of diligence, grant title to the Association and to locate and

proceed with another licensee.

7. If any Invention is made with the joint support of the Association and any agency or department of the

United States Government, the Association may defer to the patent policy of that agency or department

upon written statement by the appropriate agency of government notifying the Association of its position

with respect to the Invention in question.

8.

If any Invention is made with the joint support of the Association and some other organization, not an

agency or department of the U.S. Government, that organization, the institution, the inventor(s), and the

Association will confer to arrive at a mutually satisfactory disposition of the Invention rights.

Address all correspondence regarding this policy to:

Alzheimer's Association®

Medical & Scientific Relations—Grant Operations

225 N. Michigan Avenue — 17th Floor

Chicago, 11, 60601-7633


C

Ex. C. Pg. 82



(2015-0717)

SOW

Longitudinal Evaluation Of Amyloid Risl and Neurodegeneration (LEARN)

The primary goal of the A4 trial is to test the hypothesis that decreasing Al3 burden in the

preclinical stages of AD will slow the rate of clinical decline, as assessed with a sensitive

cognitive composite primary outcome. We will also investigate the impact of anti-amyloid

therapy on multiple imaging modalities and biomarkers, including PET amyloid imaging,

volumetric MRI, and cerebrospinal fluid levels of

Ap,

phospho-tau and total tau in a subset of

participants. The A4 study also incorporates several novel outcomes, including a computerized

cognitive composite (C3) administered on the iPad, participant reported outcomes for self-

assessment of memory function, and functional connectivity MRI to assess impact of anti-

amyloid therapy on brain network function. The A4 study provides a critical opportunity to more

appropriately test the amyloid hypothesis at a stage when Ap may still drive the AD biologic

cascade, and determine the impact of anti-A13 therapy on neuronal loss and cognitive decline,

prior to widespread irreversible damage. The findings from this study should provide decisive

evidence to support (or refute)

Ap

as a viable strategy for disease-modifying therapy, and will

serve to greatly enhance the design, conduct, and efficiency of future early intervention trials.