DanielDaniel EksteenEksteenSAAVI Business ManagerSAAVI Business ManagerBComm LLB LLM MBABComm LLB LLM MBA

the SAAVI mthe SAAVI mission ission ……

……developing an developing an affordableaffordable, ,

effectiveeffective andand locally relevantlocally relevant

preventativepreventative HIV vaccineHIV vaccine

forfor southern Africa southern Africa ……

why awhy a……

SA has the highest AIDS prevalence in the SA has the highest AIDS prevalence in the world world

dominance of the clade C, HIV virusdominance of the clade C, HIV virus

historyhistory……90/10 cost vs. benefit problem 90/10 cost vs. benefit problem historically it took up to 20 years for a new vaccine to historically it took up to 20 years for a new vaccine to reach the developing worldreach the developing world……

… SA initiative?… SA initiative?

Genetic diversity of HIV subtypes - mostly “C” in Southern Africa -

(Los Alamos database, 2000)

SAAVI business structureSAAVI business structure……

a a ““fractalfractal”¹”¹ business structure of scientific research business structure of scientific research groups located at centres of excellence throughout the groups located at centres of excellence throughout the country; supported by a central directorate; and held country; supported by a central directorate; and held together by:together by:

a common vision and spirita common vision and spirita shared brand (yet not exclusive)a shared brand (yet not exclusive)information sharing and communicationinformation sharing and communicationshared leadershipshared leadershipsynergy, i.e. 1 + 1 = 5synergy, i.e. 1 + 1 = 5

¹ Wolfgang Grulke - “Ten lessons from the future”“the organisational structure of the future”

…so, what do the SAAVI research groups do?

Immunologyassessment

HumanAnimal

Making the vaccines

Ethicalissues

CommunityPreparedness

ActuarialAssessments

Testing thevaccines

Behavioralscience

Data &Bioinformatics

SAAVIDirectorate

SAAVIDirectorate

...in a ...in a globalglobal business networkbusiness network

IP policy influenced byIP policy influenced by……

relationships with key stakeholders influence/ relationships with key stakeholders influence/ determine our IP policies: determine our IP policies:

fundersfunders:: no financial return no financial return butbut ““protectprotect””research groupsresearch groups:: get funding, keep infrastructure get funding, keep infrastructure butbut SAAVI holds IP exploitation rightsSAAVI holds IP exploitation rightsmanufacturers:manufacturers: our aim is to get: price control + our aim is to get: price control + guaranteed access + rights to tech transferguaranteed access + rights to tech transferothers: others: anyone can have access to our patented anyone can have access to our patented genes genes butbut as long as we get as long as we get …………

key stakeholderskey stakeholders……..

protection, why protection, why ……? ?

help drive our strategic missionhelp drive our strategic missionprotect the investment in locally developed IPprotect the investment in locally developed IPproduct/outcome driven investmentproduct/outcome driven investmentpeople take success seriouslypeople take success seriouslyincreases negotiating power/ draws investment increases negotiating power/ draws investment

……

how to protect effectivelyhow to protect effectively……

mutually beneficial relationshipsmutually beneficial relationshipscentrally coordinated and balanced contractscentrally coordinated and balanced contracts

MTAMTA’’ssnonnon--disclosure/ confidentiality agreementsdisclosure/ confidentiality agreementslicensing agreementslicensing agreements

patents, trademarks and copyrightpatents, trademarks and copyrightconsider cost vs. commercial benefit vs. enforceabilityconsider cost vs. commercial benefit vs. enforceability

……

we always we always ……

distinguish between the rights of:distinguish between the rights of: the the innovation, ownership and exploitationinnovation, ownership and exploitationwant down the line:want down the line: guaranteed access and guaranteed access and price controlprice controlwant as first prize:want as first prize: royalty free exclusive royalty free exclusive right to exploitation in southern Africaright to exploitation in southern Africaand want:and want: a right of first refusal should a a right of first refusal should a partner not want to exploitpartner not want to exploit

……

IP issues experiencedIP issues experienced……

control over the groupscontrol over the groups’’ actions in a actions in a decentralized structuredecentralized structure

solution:solution: centralize IP management centralize IP management mutually beneficial contracts that tie them inmutually beneficial contracts that tie them in

ensuring that information is not disclosed ensuring that information is not disclosed prior to lodging for protectionprior to lodging for protection

solution: solution: difficultdifficult…… sensitize them repeatedly sensitize them repeatedly

patent transgressions and legal liabilitypatent transgressions and legal liabilitysolution: solution: difficultdifficult…… contractual and management contractual and management control; legal liability insurancecontrol; legal liability insurance

……

IP issues continuedIP issues continued……

contradicting contractual termscontradicting contractual termsfinding that a Group we are supporting financially have finding that a Group we are supporting financially have a prior undisclosed contract with another agency in a prior undisclosed contract with another agency in terms of which they have given such agency control of terms of which they have given such agency control of their IPtheir IP

solution:solution: comprehensive legal due diligence; comprehensive legal due diligence; rere--negotiating our agreement with them; and support them in negotiating our agreement with them; and support them in rere--negotiating their contract with the other agencynegotiating their contract with the other agency

missing patent deadlines missing patent deadlines Coordinating the input of scientists, lawyers and patent Coordinating the input of scientists, lawyers and patent agents; comply with time deadlines and queries agents; comply with time deadlines and queries

solution: solution: consider an operational input process flow of all consider an operational input process flow of all players and assign responsibilities and a central point of contrplayers and assign responsibilities and a central point of controlol

……

Thank you !Thank you !Thank you !

...our main funders