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Memorandum of Understanding between the Government of Samoa and the Regents of the University of California, Berkeley for Disposition of Future Revenue from Licensing of Prostratin Gene Sequences, an Anti-Viral Molecule [2004] PITSE 1 (13 August 2004)

MEMORANDUM OF UNDERSTANDING BETWEEN THE GOVERNMENT OF SAMOA AND THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, BERKELEY FOR DISPOSITION OF FUTURE REVENUE FROM LICENSING OF PROSTRATIN GENE SEQUENCES, AN ANTI-VIRAL MOLECULE

(13 August 2004)

I. Preamble

This Memorandum of Understanding, effective as of the date of final signature, is undertaken by the government of Samoa (“Samoa”), a sovereign nation, and The Regents of the University of California, Berkeley acting through its Office of Technology Licensing at the University of California, Berkeley at 2150 Shattuck Ave., Suite 510, Berkeley, CA 94720-1620 (“UC Berkeley”).

Samoa is an island nation whose people for thousands of years have faithfully accumulated and transmitted from generation to generation knowledge about the healing properties of their island plants. With permission of the Samoan government, the Chiefs and Orators of Falealupo village (such permission later formalized as the Falealupo Covenant), and healers Epenesa Mauigoa and Pela Lilo, in 1984 Paul Alan Cox, Ph.D. began research on Samoan medicinal plants, which culminated in the discovery of the anti-viral properties of prostratin, isolated from the Samoan mamala tree, Homalanthus nutans. Both the indigenous intellectual property and the genetic material of the mamala tree are part of the national sovereignity of Samoa, as recognized by Samoan custom, Samoan law, and the Convention on Biodiversity.

UC Berkeley is one of the world’s leading universities. For more than a century it has invested millions of dollars in laboratories, laboratory equipment, faculty recruitment, and the training of faculty and students, including that of Paul Alan Cox, Ph.D. who was a Miller Research Fellow at the Miller Institute for Basic Research in Science from 1981 - 1983. Part of the training Dr. Cox received at UC Berkeley helped prepare him to do ethnobotanical research and to identify the Samoan mamala tree, Homalanthus nutans, as of significant biological interest.

This agreement sets forth an understanding between Samoa and UC Berkeley regarding the future distribution of revenue from UC Berkeley’s licensing of intellectual property rights that may arise from research performed at UC Berkeley in the laboratory of Professor Jay D. Keasling, using Samoa’s indigenous genetic material of the mamala tree. Professor Keasling proposes to identify and isolate the genes responsible in Homalanthus nutans and other plants to produce prostratin and other related non-tumor promoting phorbol esters (and their derivatives) as anti-viral remedies in a commercially viable manner, in collaboration with Samoa. This collaboration may result in new intellectual property rights that may be licensed to commercialize Prostratin.

II. Contributions of the Samoan People to World Health

Although prostratin had previously been isolated from plants in New Zealand and Australia, and although species of the genus Homalanthus occur throughout the South Pacific, it was Dr. Cox’s ethnobotanical study of traditional Samoan medicine which first caused the compound to be screened by the US National Cancer Institute for potential antiviral properties. Contributions of the Samoan people and their traditional medicinal practices relating to the discovery of the potential use of prostratin against viral illness should be recognized as important in the search for effective anti-viral drugs. The generosity of Samoan villages, chiefs, families, and healers in allowing plants used by healers to be collected should be reciprocated in the event that prostratin is marketed as an anti-viral remedy. Such reciprocation could be helpful in preserving existing rainforest land, furthering the mission of the Parks and Conservation Authority, and maintaining the healing traditions and health of the Samoan people.

III. Uncertainties of Drug Development

UC Berkeley and its collaborating researchers and scientists cannot yet ascertain if prostratin will be useful in treating viral illness, nor can UC Berkeley assert that prostratin will be a viable commercial drug licensed the US Food and Drug Administration. Many steps remain in the testing and development process, steps that are out of the control, supervision, or influence of UC Berkeley. However, both UC Berkeley and Samoa deem it wise at this point to investigate genetic technology as a potential path to producing a stable supply of prostratin, should it be approved as an anti-viral remedy at some future date.

IV. Research Collaboration

Samoa and UC Berkeley agree to facilitate a research program to produce a stable supply of prostratin, with any income of these efforts to be allocated as shown in section V below. In this research, Samoa will:

a. allow UC Berkeley researchers and their bona fide colleagues access to Samoa for research purposes with a minimum of delay or hindrance;

b. allow import of all necessary research equipment, materials, and vehicles used by UC Berkeley and its researchers, without payment of tax or duty, as long as such research equipment, materials, and vehicles are clearly identified and declared to the Samoan government, and are exported from the country after their use;

c. allow export from the country of living material and genetic collections of Homalanthus nutans and related plants without hindrance or delay, on the condition that UC Berkeley destroy or return to Samoa all seeds, propagules, cell cultures, or other propagative materials at the conclusion of this research, unless otherwise expressly permitted by the Samoan government.

In this research, UC Berkeley will

a. acknowledge the intellectual contribution of Samoa to this research in all press releases, press conferences, publications and oral presentations;

b. obtain prior informed consent of villages or other landowners prior to collection of any living material or genetic material of Homalanthus nutans from their lands;

c. name, wherever possible, any new gene, gene sequence, or gene product discovered during the research in such a way that the connection of the gene, gene sequence, or gene product to Samoa and Samoa’s national sovereignty will be clear to other researchers;

d. endeavor to protect by patent, copyright, or other legal mechanism all discoveries and products, arising directly from this research under the direction of Professor Jay D. Keasling at UC Berkeley or at Samoa that may have commercial value, with the understanding that UC Berkeley is not obligated to file patent applications unless it has a foreseeable mechanism for recovering the costs through licensing;

e. exert reasonable efforts in licensing such patents or copyrights for public benefit, keeping in mind UC Berkeley’s and Samoa’s mutual goals of providing low cost therapies for free, at cost, or with minimal profit in the developing world;

f. provide an annual report to the Samoan Prime Minister or his assignee of the scientific progress during the period that the research is being conducted including copies of all relevant scientific publications, a statement of patent, copyright, and licensing activity;

g. share revenue with Samoa in accordance with Article V.

V. Terms of Recognition of the Contribution of the Samoan Land and People to
the Development of a Gene Product for Prostratin

In consideration for the assistance of the Samoan people in bringing prostratin to the attention of researchers developing treatments for viral diseases, and in consideration for their preservation of genetic resources of Homalanthus nutans and related diseases, UC Berkeley agrees to the following terms as reciprocation for the public health benefits that the Samoan people made possible. From the proceeds of all of licenses, benchmark payments, royalties, technologies and any other income that results from UC Berkeley’s licensing of intellectual property arising directly from this research under the direction of Professor Jay D. Keasling at UC Berkeley or at Samoa (after first reimbursing to UC Berkeley all reasonable and necessary patent costs, legal fees, and other necessary and reasonable costs pursuant to obtaining, maintaining, and protecting the intellectual property, and provided that all UC Berkeley inventors of a given patent application agree in writing to the following revenue distribution) UC Berkeley will provide 50% of such net revenue to Seacology, a non-profit Foundation incorporated under the laws of the United States, and with offices in Berkeley, California, which shall distribute their share of the royalties as follows:

a. 50% to the Samoan government

b. 33% to Falealupo village, paid in trust for the benefit of Falealupo village and administered by Seacology, a non-profit Foundation incorporated under the laws of the United States, and with offices in Berkeley, California;

c. 2% to Saipipi village, paid in trust for the benefit of Saipipi village and administered by Seacology, a non-profit Foundation incorporated under the laws of the United States, and with offices in Berkeley, California;

d. 2% to Tafua village; paid in trust for the benefit of Tafua village and administered by Seacology, a non-profit Foundation incorporated under the laws of the United States, and with offices in Berkeley, California;

e. 8% to other villages; that will participate in this research by allowing access to genetic material in their forests, or who have begun growing commercial crops of Homalanthus nutans at the day of FDA approval of prostratin or its analogues as a drug, in a reasonable and equitable manner solely to be decided by Seacology, and paid in trust for the benefit of these villages and administered by Seacology, a non-profit Foundation incorporated under the laws of the United States, and with offices in Berkeley, California;

f. 2% to the lineal descendents of Epenesa Mauigoa, late of Pesega village, being the first healer to identify for Dr. Paul Cox Homalanthus nutans as having potential activity against diseases of viral origin, to be paid in trust to Seacology for the health, education, and well-being of said descendants and administered by Seacology, a non-profit Foundation incorporated under the laws of the United States, and with offices in Berkeley, California;

g. 2% to the lineal descendents of Pela Lilo, late of Falealupo village, being the second healer to identify for Dr. Paul Cox Homalanthus nutans as having potential activity against diseases of viral origin, to be paid in trust to Seacology for the health, education, and well-being of said descendants and administered by Seacology, a non-profit Foundation incorporated under the laws of the United States, and with offices in Berkeley, California;

h. (1%?)0. 5% to Seacology, a non-profit Foundation incorporated under the laws of the United States, and with offices in Berkeley, California; for its good offices in coordinating payments b through g.

VI. Commercialization of Prostratin and Special Considerations for Developing
Countries

Samoa and UC Berkeley intend to license their respective intellectual property rights so
that prostratin (if it is approved as an anti HIV-AIDS therapy) is made available to developing nations at minimal cost. UC Berkeley shall use reasonable efforts in negotiating with any third party licensee to include terms for the distribution of the drug in developing nations at a minimal profit. In addition Professor Jay D. Keasling shall emphasize the generosity of the Samoan people, the dignity of the Samoa culture, and the contribution made to public health by the indigenous medicine practiced by Samoan healers in all presentations and publications in which the collaborative work is described. Professor Keasling will also work to see that Samoa receives the diplomatic credit it deserves in furthering the distribution of prostratin (if approved) to those developing nations hit hard by HIV/AIDS but who would be burdened by payments substantially driven by profit.

V. Complete Agreement between the Parties

Both the government of Samoa and UC Berkeley agree that this Memorandum states the entire understanding between the parties, and that no other promises- written, oral, or implied- shall govern the terms of this agreement. No parol evidence of any kind shall be used in construing the meaning of the terms of this agreement.

VI. Dispute, Controversy, Resolution

Both parties enter into this agreement in the spirit of mutual respect and gratitude. Should disputes arise under this agreement, either party may demand nonbinding arbitration. Any arbitration shall include one arbitrator chosen by Samoa, one arbitrator chosen by UC Berkeley, and one arbitrator chosen jointly by the other two arbitrators. Any arbitration shall take place at a place acceptable to both parties. Likewise, either party may demand an audit of costs and revenues covered in this agreement, no more than once a year, by an auditor acceptable to both parties. The requesting party shall bear the cost of the audit. The agreement shall be construed according to the laws of the state of California in the United States.

This agreement does not expressly or by implication affect the rights of either party in any intellectual property except as expressly provided herein.

Signed and agreed to this 13th day of August, 2004.