1. Collaboration in a Public Private Partnership in R & D for Public good Conference on Dispute Resolution in International Science and Technology Collaboration WIPO, Geneva 25 April 2005 P V Venugopal Director (International Operations) Medicines for Malaria Venture (MMV) Web: www.mmv.orgwww.mmv.org

2. MMV’s mission “Medicines for Malaria Venture is a not-for- profit foundation dedicated to reducing the burden of malaria in disease endemic countries by discovering, developing and delivering new affordable antimalarials through effective public-private partnerships.”

3. Discovery Exploratory Development FullDevelopment Registration Large Amounts of Candidate Medicine Synthesized Project Team and Plans Synthesis of Compounds Early Safety Studies Candidate Formulations Developed Extensive Safety Studies Screening Studies in Healthy Volunteers Phase I Candidate Medicine Tested in 3-10,000 Patients (Phase III) Studies in 100-300 Patients (Phase II) Clinical Data Analysis Long road to a new medicine

4. MMV’s global network of R&D partnership

5. GSK at Tres Cantos Collaboration Partners in R & D Courtesy: GSK Tres Cantos

6. Joint R&D MMV Input $$$ Drug Profile Background IPR Link to WHO/Policy Malaria Expertise Pharma Chemistry IPR Toxicology Know How Assets in Kind Technology MMV Gets Rights in DEC IPR in ‘Field’ Drug Supply Return on non DEC Sales Pharma/Bio Gets Rights in non DEC IPR outside ‘Field’ PR Benefit HR Benefit Validation of Technology Public Private A Public-Private Partnership for the Discovery and Development of Anti Malarial Drugs

7. MMV Synthetic Peroxide Project - an example of International Partnership Project team: University of Nebraska Swiss Tropical Institute Monash University Roche/Basilea Ranbaxy Laboratories + Outsourced Support Cideim St George’s Hospital Medical School Quintiles Pharmalytics Inveresk Unimark RCC Fulcrum Basilea Cerb Cerep Maccine MDS ICGEB

8. Priorities are not the same for different partners Pharma Companies University / Public Research Institution Scientists Public Private Partnerships Government Profit* Recognition, more research scientists, creation of facilities Fame, money, ability to add research students to team Public Health, Public good Political gains / Recognition *MMV had to drop a Project because of the Pharma partner’s insistence on profit

9. ‘Ideal Agreements?’ ‘Prevention better than cure’ – It is better to go into all details before finalizing the Agreement of Collaboration, in order to avoid disputes later** 1.Create better understanding among all the partners and clarify all aspects before the commencement of collaboration 2.Specify in the Agreement the mode of action in respect of all points of possible causes of dispute: e.g. use ‘outside field’ of a Pharma NCE under development, ownership of IPR created during collaboration etc. 3.Give due credit to the Scientists (generally in Universities / Academic Institutions) whose original idea is being ‘commercialized’ 4.Ensure that both the individual scientist (s) and the University / Institution benefits from the collaboration. 5.Respect the ‘sensibilities’ of all partners in respect of multiparty Agreements ** There are examples of Agreements which have taken over a year in negotiation. It is actually worth disputes are avoided later.

10. Thank you