WORLD TRADE
ORGANIZATIONIP/C/W/341
25 March 2002
(02-1523)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
TECHNOLOGY TRANSFER PRACTICES OF THE US NATIONAL CANCER
INSTITUTE’S DEPARTMENTAL THERAPEUTICS PROGRAMME
Communication from the United States
The following communication has been received from the Permanent Mission of the United
States on 6 March 2002, with the request that it be circulated as an unrestricted Council document.
_______________
During the meeting of the TRIPS Council in April of 2001, the United States introduced a
paper, IP/C/W/257, discussing the relationship be tween the Convention on Biological Diversity and
the TRIPS Agreement.  In that paper, the United  States noted that the most effective means for
providing access to genetic resources, and for ensuring that any benefits that arise from their use are
shared fairly and equitably, would be through contracts between those granting access to the resources
and those to whom access is granted.  This document describes the practices of the US National
Cancer Institute’s Departmental Therapeutics Prog ramme (NCI-DTP) in collecting genetic materials
for screening for potential therapeutic uses related to cancer.
Background
The DTP is the drug discovery programme of the NCI.  The NCI-DTP is currently screening
synthetic compounds and natural product materials de rived from plants, marine macro-organisms and
microbes as potential sources of novel anti-cancer drugs.  Since 1986, the Natural Products Branch of
the NCI-DTP has acquired 53,000 plant and 13,000 marine invertebrate samples, in addition to 3,000marine plants and 25,000 fungal extracts from more than 30 tropical or sub-tropical source countries
or their source country organizations.  Aqueous and organic extracts (methylene chloride/methanol) of
each of these materials have been prepared and are now available for high throughput screening in
1,650 microtiter plate maps (88 extracts per plate).  In addition, taxonomy is available for each
specimen.  The chief use for screening such a unique resource is to isolate, identify and characterize alead compound whose activity can be further developed through combination with other compounds
or other synthesizing methodologies.  The extracts, however, are available (under a Natural Products
Repository-Material Transfer Agreement, NPR/MTA) to other scientific laboratories for screening
against all diseases.
As it investigates the potential of natural products in drug discovery and development,
NCI-DTP seeks to promote the conservation of biological diversity, and recognizes the need to
collaborate with source country organizations in the development of any drug from an organism
collected within a source country’s borders from source country organizations and peoples and, in the
event of commercialization of any drug so deve loped, to provide compensation or other benefits
resulting from that commercialization.  Most of the sample materials screened by NCI-DTP have been
obtained under Letters of Collection (LOC) or Memoranda of Understanding (MOU) negotiated withIP/C/W/341
Page 2
or involving the source countries.  Copies of the basic Natural Products Repository-Material Transfer
Agreement, the Letters of Collection, and the Me morandum of Understanding are included as annexes
to this paper.
General Principles and Policies of the National Cancer Institute
Because the NCI recognizes the value of the natural resources (plant, marine, microbial)
being investigated and of the significant contributions made by source country organizations and
indigenous peoples to the NCI programmes, it has established policies that facilitate collaboration
with and compensation of countries particip ating in the NCI drug discovery programme.
NCI NPB complies with the principles of the Convention on Biological Diversity by
providing in its negotiated agreements that source countries share, in a fair and equitable way, in the
results of research and development and in any benefits arising from commercial and other use of
their genetic resources.  In addition, the agreements provide that source country people and
organizations are to be compensated if a drug (which originated from natural materials or compounds
submitted to the NCI) is commercialized by a potential licensee.
The NCI and the National Institutes of Health-Office of Technology Transfer (NIH-OTT)
require licensees to negotiate agreements with source countries or source country organizations that
addresses concerns of both parties, ensuring that, inter alia, pertinent agencies, institutions and/or
persons receive royalties and other forms of compensation, as appropriate.  The royalties to anysource country depend upon the relationship of the marketed drug to the original lead from the extract.
To increase the efficacy of source country compensation, generally the licensee is expected to
begin and complete negotiations with the source country or source country organization as soon as
possible (typically within one year of signing the licensing agreement).  In no case, however, may alicensee initiate negotiations later than at th e commencement of clinical trials, or complete
negotiations later than the commercialization/sale of a drug.   To ensure that potential licensees
understand these obligations, the NIH-OTT, in disseminating licensing announcements in the US
Federal Register concerning such natural product materials, includes the following language:  "Since
[compound] was originally isolated from flora primarily located in [location], the NIH is concerned
that the collection and utilization of the natural material comport with all applicable Federal and
[location] policies related to biodiversity.  In order to comport with such policies, the successfulapplicant will also be required to negotiate and enter into agreements with the appropriate [location]
Government agencies."
In instances in which additional supplies of a naturally-occurring material or compound are
required, they must be sought first in the original source country, if possible, in order to promotedevelopment of the agent within that source country.
NCI-DTP also tries to transfer knowledge, expertise, and technology related to drug
discoveries and development to source country organizations, subject to the provision of mutually
acceptable guarantees for the protection of any patented technology.  NCI sponsors a programmewhereby source country scientists are able to work as guest researchers at NCI or other mutually
acceptable organizations for up to one year.
While in the past, NCI-DTP scientists have predominantly isolated and characterized the
biologically-active extract constituents, under the MOU (a collaborative agreement between the NCIand source country organization), qualified source c ountry organizations are encouraged to isolate and
characterize biologically-active constituents themselves and patent the active agents solely or jointly.IP/C/W/341
Page 3
The NCI-DTP will collaborate with the source country organization through pre-clinical
development of a drug.  Under an MOU, joint patents may be sought on all inventions made by the
source country organization and NCI working jointly with inventorship being determined in
accordance with the relevant patent laws.
For compounds determined to possess significant anticancer potential and, therefore,
scheduled for clinical trials, the US Government receives a royalty-free, irrevocable, non-exclusive
licence to manufacture and/or use, by or for th e US Government, the invention(s) or process(es)
claimed in any patent(s) obtained, or that may be obtained by a source country organization on such
compounds.  Such licences are limited to compounds relying on NCI-DTP anticancer screening data,
and are only for purposes of medical research related to or connected with cancer therapies and not for
commercial use.
The NCI has MOU Agreements for direct collaboration with the following entities:
Australia
Australian Institute of Marine Sciences, Townsville, Queensland.
Bangladesh
The University of Dhaka
Brazil
Fundacao Oswaldo Cruz – FI OCRUZ, Rio de Janeiro
South American Organization for Antican cer Drug Development, Porto Alegre
Universidade do Paulista, Sao Paulo
Universidade Federal do Parana
Universdade Federal do Ceara, Forteleza
China
Hong Kong University of Science and Technology
Kunming Institute of Botany, Yunnan
Peking University and State Key Laboratory, Beijing
Costa Rica
Instituto Nacional de Biodiversidad (INBio)
Fiji
University of the South Pacific, Suva
Iceland
The University of Iceland, Reykjavik
Korea
Korean Research Institute of Chemical Technology (KRICT)
Mexico
Instituto de Quimica, Universidad Nacional Autonoma de Mexico, Mexico City
New Zealand
National Institute of Water and Atmospheric Research (NIWA), Wellington
Nicaragua
Universidad Nacional Aut onoma de Nicaragua, LeonIP/C/W/341
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Pakistan
HEJ Research Institute of Chemistry, University of Karachi
Papua New Guinea
University of Papua New Guinea, Port Moresby
Panama
University of Panama
South Africa
Council for Scientific and Industrial Research (C SIR), Division of Food , Biological and Chemical
Technologies (BIO/CHEMTEK), Pretoria
Rhodes University, Grahamstown
Zimbabwe
Zimbabwe National Traditional Healers Association (ZINATHA)
In addition, negotiations for MOUs are currently in progress with the following organizations:
Brazil
Centro Pluridisciplinar Pesquisas Quimic as, Universidade do Campinas (UNICAMP)
Egypt
National Research Center, Cairo (under negotiation)
Jamaica
(University of the West Indies)
Russia
Cancer Research Center, Russian Ac ademy of Medical Sciences, Moscow
The NCI has LOC Agreements for collaboration in the collection of plants and marine
organisms with the following:
Bangladesh
Bangladesh National Herbarium, Dhaka
Cambodia
Forest and Wildlife Research Institute, Department of Forestry and Wildlife, Phnom Penh
Ecuador
The AWA Peoples Federation
Gabon
Centre National de la Recherche Scientifiq ue et Technologique (CENAREST), Libreville
Ghana
University of Ghana, Legon
Laos
Research Institute of Medicinal Plants, Ministry of Public Health, VientianeIP/C/W/341
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Madagascar
Centre national d’applications des recherches pharmaceutiques, Antananarivo
Papua New Guinea
University of Papua New Guinea, Port Moresby
Philippines
Philippines National Museum, Manila
Sarawak, Malaysia
State Government of Sarawak:  State Department of Forests
Tanzania
Traditional Medicine Research Institute, Muhumbili University College of Health Sciences,
University of Dar Es Salaam
Vietnam
Institute of Ecology and Biological Resources, National Center for Natural Science and Technology,
Hanoi
Other collaborating source countries
NCI collections have also been performed in a number of other countries, which have not, as
yet, signed official LOC agreements.  NCI, however, is totally committed to the terms of the LOC
irrespective of whether or not an official agreement has been signed.  These countries are:
Bahrain, Belize, Bolivia, Cameroon, Centra l African Republic, Colombia, Dominica,
Dominican Republic, Federated States of Micr onesia (Chuuk, Yap etc.), Guatemala, Guyana,
Honduras, Indonesia, Malaysia, Maldives, Marshall Islands, Martinique, Mauritius, Nepal, Palau,
Paraguay, Peru, St. Lucia, Thailand, Tonga.IP/C/W/341
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ANNEX I
MEMORANDUM OF UNDERSTANDING BETWEEN
[SOURCE COUNTRY ORGANIZATION]
AND
THE DEVELOPMENTAL THERAPEUTICS PROGRAMME
DIVISION OF CANCER TREATMENT AND DIAGNOSIS
NATIONAL CANCER INSTITUTE
The Developmental Therapeutics Programme (DTP), Division of Cancer Treatment and
Diagnosis (DCTD), National Cancer Institute (NCI) is currently screening synthetic compounds andnatural product materials derived from plants, marine macro-organisms and microbes as potential
sources of novel anticancer drugs.  The DTP is th e drug discovery programme of the NCI which is an
Institute of the National Institutes of Health (NIH), an arm of the Department of Health and Human
Services of the United States Government.  While investigating the potential of natural products in
drug discovery and development, NC I wishes to promote the conservation of biological diversity, and
recognizes the need to compensate source country organizations and peoples in the event of
commercialization of a drug developed from an organism collected within their countries’ borders.
DTP/NCI has an interest in investigating plants, terrestrial and marine microorganisms and
marine macro-organisms from [Source Country], and wishes to collaborate with the [Source Country
Organization ("SCO")] in this investigation. DTP/NCI will make sincere efforts to transfer
knowledge, expertise, and technology related to dr ug discovery and development to [SCO] in [Source
Country]  (as the agent appointed by the [Source C ountry] Government), subject to the provision of
mutually acceptable guarantees for the protection of intellectual property associated with any patented
technology.  [SCO], in turn, desires to collab orate closely with the DTP/NCI in pursuit of the
investigation of [Source Country]'s terrestrial plants, marine macro-organisms and microorganisms,
and selected synthetic compounds subject to the following conditions and stipulations of this
Memorandum of Understanding (MOU).
(1) On the basis of in-house screening results in its anticancer screens,  [SCO] may select
both synthetic compounds and extracts of  plants, marine macro-organisms and
microorganisms (subject to previously determined limits as to numbers per year) foranticancer testing at DTP/NCI. If suitable in-house screens are not available, a list of
available materials may be sent to DTP/NCI giving data as requested in Articles 2
and 3 below.
(2) Prior to submission of the materials, [SCO] will send a data sheet, to be held in
confidence by DTP/NCI, on each material so that DTP/NCI may check its databasesfor records of prior submission to DTP/NCI.
(3) For pure compounds, the data sheet(s) will give pertinent available data as to
chemical constitution, structure, biological data, solubility, toxicity and any
precautions which need to be followed in handling, storage and shipping.
For crude extracts, data will be provided as to the source organism taxonomy,
location and date of collection, any hazards associated with the organism, available
biological data and any known medici nal uses of the organism/extracts.IP/C/W/341
Page 7
(4) DTP will inform [SCO] which of the materials are new to the programme, and such
materials will be shipped to DTP for screening.  DTP will provide a record of the
accession number for the materials.  Quantities of materials required for initial testing
are 5 mg for pure compounds and 10 mg for crude extracts.
(5) All test results will be provided to [SCO] as soon as they are available, but not later
than 270 days (nine months) from the date of receipt of the sample.  If available, in
vitro test results will be delivered within 90 days from receipt of the sample.  [SCO]
will be informed in writing of any delays beyond this period (270 days) together with
an explanation of the reason(s) for delay.
Data provided by [SCO] will be considered as confidential information of [SCO], if
so labeled, and will be held confidentially by DTP/NCI, unless the data are already in
the public domain.  No data about the materials will be kept in files open to the publiceither by DTP/NCI,  testing laboratories, or data processing facilities, all of which are
US government contractors.  Only those employees directly engaged in the operation
of DTP/NCI will have access to the files of information regarding the source and
nature of confidential materials and results of testing, unless the release of data about
the materials or the results of the testing are required under statute or by court order.
(6) Any extracts exhibiting significant activity will be further studied by bioassay-guided
fractionation in order to isolate the pure compound(s) responsible for the observed
activity.  Such fractionation will be carried out  in [SCO] laboratories.  If  [SCO] has
no available bioassay, DTP/NCI will assist [SCO] to establish the necessary bioassaysystems subject to the availability of the necessary resources. Alternatively, or in
addition, suitably qualified designated [SCO] scientists will be sent to DTP/NCI for
the isolation studies subject to the terms stated below in Article 7.  In addition, during
the course of this MOU,  DTP/NCI will assist the [SCO], thereby assisting the [SC],
to develop the capacity to undertake drug discovery and development, includingcapabilities for the screening and isolation of active compounds from terrestrial and
marine organisms.
(7) Subject to the provision that suitable laboratory space and other necessary resources
are available, DTP/NCI agrees to invite senior technician(s) and/or scientist(s)
designated by [SCO] to work in the laboratories of DTP/NCI or, if the parties agree,
in laboratories using technology which would be useful in furthering work under this
MOU.  The duration of such visits would not exceed one year except by prioragreement between [SCO] and DTP/NCI.  The designated "Visiting Scientist(s)" will
be subject to provisions usually governing Guest Researchers at NIH, except when
carrying out research on materials provided by [SCO].  Costs and other conditions of
visits will be negotiated in good faith prior to the arrival of the scientist(s).
(8) In the event that an agent isolated and purified from materials provided by [SCO],
and/or a synthetic compound provided by [SCO] meets the criteria established by the
Drug Development Group (DDG) of NCI’s DCTD (DTP’s parent organization),
which would include, but not be limited to, in vivo activity in rodent models, further
development of the agent will be undertaken by DTP/NCI in collaboration with
[SCO].  Once an active agent is approved by DTP/NCI for preclinical development(i.e., has passed the DDG at Stage IIA),  DTP/NC I will collaborate with [SCO]
scientists in the development of the specific agent.IP/C/W/341
Page 8
(9) Both [SCO] and DTP/NCI recognize that inventorship will be determined under
patent law.  DTP/NCI and [SCO] will, as appropriate, jointly seek patent protection
on all inventions developed jointly under this MOU by DTP/NCI and [SCO]
employees, and will seek appropriate protection abroad, including in [Source
Country], if appropriate. Application for patent protection on inventions made by[SCO] employees alone will be the responsib ility of [SCO].  Application for patent
protection on inventions made by DT P/NCI employees alone will be the
responsibility of DTP/NCI.
With respect only to those compounds that have been determined to possess such
significant anti-cancer potential as to be scheduled for clinical trials by DCTD, the
US Government shall have a royalty-free, irrevocable, non-exclusive licence to
manufacture and/or use by or for the US Government the invention(s) claimed in anypatents that [SCO] may have or may obtain on such compounds or on a process for
use of such compounds.  However, this licence will apply only to [SCO] patents that
rely upon data generated by DTP/NCI or DTP/NCI testing laboratories.  This licence
shall be only for medical research purposes related to or connected with the therapy
of cancer.  The term "medical research purposes" as used herein shall not includetreatment of patients outside of clinical trials or commercial distribution of the
compounds.
(10) DTP/NCI will make a sincere effort to transfer any knowledge, expertise, and
technology developed during such collaboration in the discovery and developmentprocess to [SCO], subject to the provision of mutually acceptable guarantees for the
protection of intellectual property associated with any patented technology.
(11) All licences granted on any patents aris ing from the collaboration conducted under
the terms of this MOU shall contain a clause referring to this MOU and shall indicate
that the licensee has been apprised of this MOU.
(12) Should the agent eventually be licensed to a pharmaceutical company for production
and marketing, DTP/NCI will require the licensee to negotiate and enter into
agreement(s) with [SCO] and/or an appropriate [Source Country] Government
agency(ies). The agreement(s) will address the concern on the part of the [Source
Country] government that pertinent agencies, institutions and/or persons receive
royalties and other forms of compensation, as appropriate.
Such terms will apply equally to instances where an invention is directed to a direct
isolate from a natural product material, a product structurally based upon an isolate
from the natural product material, a synthetic material for which the natural product
material provided a key development lead, a derivative of a synthetic compound
provided by [Source Country ] or [SCO], or a method of synthesis or use of any
aforementioned isolate, product, material or derivative; though the percentage ofroyalties negotiated as payment might vary depending upon the relationship of the
marketed drug to the originally isolated product.  It is understood that the eventual
development of a drug to the stage of marketing is a long term process which may
require 10-15 years.
(13) In obtaining licensees,  DTP/NCI will require the applicant for licence to seek as its
first source of supply the natural products available from [Source Country].  If no
appropriate licensee is found who will use natural products available from [Source
Country], or if [SCO] or their suppliers cannot provide adequate quantities of raw
materials at a mutually agreeable fair price, the licensee will be required to pay to theIP/C/W/341
Page 9
[Source Country] Government an amount of money (to be negotiated) to be used for
expenses associated with cultivation of medicinal plant species that are endangered
by deforestation, or for other appropriate conservation measures.  These terms will
also apply in the event that the licensee begins to market a synthetic material for
which a material from [Source Country] provided a key development lead.
(14) Article 13 shall not apply to organisms which are freely available from different
countries (i.e., common weeds, agricultural crops, ornamental plants, fouling
organisms) unless information indicating a particular use of the organism (e.g.,
medicinal, pesticidal) was provided by local residents to guide the collection of such
an organism from [Source Country], or unless other justification acceptable to both
[SCO] and DTP/NCI is provided.  In the case where an organism is freely available
from different countries, but a phenotype producing an active agent is found only in[Source Country], Article 13 shall apply.
(15) Publication of data resulting from the collaboration under this MOU will be
undertaken at times determined by agreement between [SCO] and DTP/NCI.
(16) It is the intention of NCI that [SCO] not be liable to DTP/NCI for any claims or
damages arising from NCI's use of the material provided by [SCO];  however, noindemnification for any loss, damage, or liability is intended or provided by any party
under this MOU.  Each party shall be liable  for any loss, claim, damage or liability,
that said party incurs, as a result of said party's activities under this MOU, except that
the NCI, as an agency of the United States, assumes liability only to the extent as
provided under the Federal Tort Claim Act (28 USC §171).
(17) DTP/NCI will not distribute materials provided by [SCO] to other organizations
without written authorization from [SCO].  However, should [SCO] wish to consider
collaboration with organizations selected by NCI for distribution of materials
acquired through NCI collection contracts, DTP/NCI will establish contact between
such organizations and [SCO].
(18) [SCO] scientists and their collaborators may screen additional samples of the same
materials for other biological activities and develop them for such purposes
independently of this MOU.
This MOU shall be valid as of  the date of th e final authorized signature below for an initial
period of five (5) years, after which, it can be renewed by mutual agreement. It may be amended at
any time subject to the written agreement of both parties. Copies of such amendments will be kept on
file at both of the addresses indicated below. [SCO] and DTP/NCI are confident that this MOU willlay the basis for a mutually successful cooperation in discovering and developing new therapies in the
treatment of cancer.IP/C/W/341
Page 10
For the [SCO]: For the National Cancer Institute:
________________________________ ____________________________________
Richard Klausner, M.D.Director, National Cancer Institute
_______________ __________________
Date Date
mailing and contact address: mailing and contact address:
Technology Transfer Branch
National Cancer Institute at Frederick
NCI-Frederick
Fairview Center, Suite 5021003 - W. 7th Street
Frederick, MD 21701-8512
Telephone: 301-846-5465
Facsimile: 301-846-6820IP/C/W/341
Page 11
ANNEX II
LETTER OF COLLECTION
Agreement Between
[Source Country Institution]
and/or [Source Country Organization]
and the
Developmental Therapeutics Programme
Division of Cancer Treatment and Diagnosis
National Cancer Institute
The Developmental Therapeutics Programme ("DTP"), Division of Cancer Treatment and
Diagnosis ("DCTD"), National Cancer Institute ("NCI") is currently investigating plants, microbes,
and marine macro-organisms as potential sources of  novel anticancer and AIDS-antiviral drugs.  The
DTP is the drug discovery programme of the NCI which is an Institute of the National Institutes ofHealth ("NIH"), an arm of the Department of Health and Human Services of the United States
Government.  While investigating the potential of natural products in drug discovery and
development, NCI wishes to promote the conservation of biological diversity, and recognizes the need
to compensate [Source Country] organizations and peoples in the event of commercialization of a
drug developed from an organism collected within their borders.
As part of the drug discovery programme, DT P has contracts with various organizations for
the collection of plants, microbes and marine macro-organisms worldwide.  DTP has an interest in
investigating plants, microbes and marine macro-organisms from [Source Country], and wishes to
collaborate with the [Source Country Government  ("SCG") or Source Country Organization(s)
("SGO")] as appropriate in this investigation.  The collection of plants, microbes, and marine
macro-organisms will be within the framework of  the collection contract between the NCI and the
NCI Contractor ("Contractor") which will collaborate with the appropriate agency in the [SCG or
SCO].  The NCI will make sincere efforts to transfer knowledge, expertise, and technology related to
drug discovery and development to the [appropriate Source Country Institution ("SCI")] in [Source
Country] as the agent appointed by the [SCG or SCO], subject to the provision of mutually acceptable
guarantees for the protection of intellectual property  associated with any patented technology.  The
[SCG or SCO], in turn, desires to collaborate closely with the DTP/NCI in pursuit of the investigation
of its plants, microbes and marine macro-organisms, subject to the conditions and stipulations of this
agreement.
The role of DTP, DCTD, NCI in the co llaboration will include the following:
(1) DTP/NCI will screen the extracts of all plants, microbes and marine macro-organisms
provided from [Source Country] for anticancer and AIDS-antiviral activity, and will
provide the test results to [SCI] on a quarterly  basis.  Such results will be channeled
via Contractor.
(2) The test results will be kept confidential by all parties, with any publication delayed
until DTP/NCI has an opportunity to file a patent application in the United States of
America on any active agents isolated.  Such application will be made according to
the terms stated in Article 6.
(3) Any extracts exhibiting significant activity will be further studied by bioassay-guided
fractionation in order to isolate the pure compounds(s) responsible for the observed
activity.  Since the relevant bioassays are only available at DTP/NCI, suchIP/C/W/341
Page 12
fractionation will be carried out in DTP/NCI laboratories.  A suitably qualified
scientist designated by [SCI] may participate in this process subject to the terms
stated in Article 4.  In addition, in the course of the contract period, DTP/NCI will
assist the [SCG or SCO], in conjunction with [SCI], to develop the capacity to
undertake drug discovery and development, including capabilities for the screeningand isolation of active compounds from plants, microbes and marine organisms.
(4) Subject to the provision that suitable laboratory space and other necessary resources
are available, DTP/NCI agrees to invite a senior technician or scientist designated by
[SCI] to work in the laboratories of DTP/NCI or, if the parties agree, in laboratories
using technology which would be useful in furthering work under this agreement.
The duration of such a visit would not exceed one year except by prior agreement
between [SCI] and DTP/NCI.  The designated Guest Researcher will be subject toprovisions usually governing Guest Researchers at NIH, except when carrying out
research on materials provided through collections in [Source Country].  Salary and
other conditions of exchange will be negotiated in good faith.
(5) In the event of the isolation of a promising agent from a plant, microbe or marine
macro-organism collected in [Source Countr y], further development of the agent will
be undertaken by DTP/NCI in collaboration with [SCI].  Once an active agent is
approved by the DTP/NCI for preclinical development, [SCI] and the DTP/NCI will
discuss participation by SCI scientists in the development of the specific agent.
The DTP/NCI will make a sincere effort to transfer any knowledge, expertise, and
technology developed during such collaboration in the discovery and developmentprocess to [SCI], subject to the provision of mutually acceptable guarantees for the
protection of intellectual property associated with any patented technology.
(6) DTP/NCI will, as appropriate, seek patent protection on all inventions developed
under this agreement by DTP/NCI employ ees alone or by DTP/NCI and [SCG or
SCO] employees jointly, and will seek appropriate protection abroad, including in
[Source Country], if appropriate.
(7) All licences granted on any patents arising from this collaboration shall contain a
clause referring to this agreement and shall indicate that the licensee has been
apprised of this agreement.
(8) Should the agent eventually be licensed to a pharmaceutical company for production
and marketing, DTP/NCI, will require the successful licensee to negotiate and enterinto agreement(s) with the [SCG] agen cy(ies) or [SCO] as appropriate. This
agreement(s) will address the concern on the part of the [SCG or SCO] that pertinent
agencies, institutions and/or persons receive royalties and other forms of
compensation, as appropriate.
(9) Such terms shall apply equally to instances where an invention is directed to a direct
isolate from a natural product material, a product structurally based upon an isolate
from the natural product material, a synthetic material for which the natural product
material provided a key development lead, or a method of synthesis or use of any
aforementioned isolate, product or material; though the percentage of royalties
negotiated as payment might vary depending upon the relationship of the marketeddrug to the originally isolated product.  It is understood that the eventual development
of a drug to the stage of marketing is a long term process which may require 10-15
years.IP/C/W/341
Page 13
(10) In obtaining licensees, the DTP/NCI will require the license applicant to seek as its
first source of supply the natural products from [Source Country].  If no appropriate
licensee is found that will use natural products available from [Source Country], or if
the [SCG] or [SCO] as approp riate, or its suppliers cannot provide adequate amounts
of raw materials at a mutually agreeable fair price, the licensee will be required to paythe [SCG] or [SCO] as appropriate, an amount  of money (to be negotiated) to be used
for expenses associated with cultivation of medicinal plant, microbe or marine
macro-organism species that are endangered by deforestation, or for other appropriate
conservation measures.  These terms will also apply in the event that the licensee
begins to market a synthetic material for which a material from [Source Country]
provided a key development lead.
(11) Section 10 shall not apply to organisms which are freely available from different
countries (i.e., common weeds, agricultural crops, ornamental plants, fouling
organisms) unless information indicating a particular use of the organism (e.g.,
medicinal, pesticidal) was provided by local residents to guide the collection of such
an organism from [Source Country], or unless other justification acceptable to both
the [SCG or SCO] and the DTP/NCI is prov ided.  In the case where an organism is
freely available from different countries, but a phenotype producing an active agent is
found only in [Source Country], Article 10 shall apply.
(12) DTP/NCI will test any pure compounds submitted by the [SCG or SCO] and [SCI]
scientists for antitumor and anti HIV/AIDS activity, provided such compounds have
not been tested previously in the DTP/NCI screens.  If significant antitumor or anti
HIV/AIDS activity is detected, further development of the compound and
investigation of patent rights will, as appropriate, be undertaken by DTP/NCI in
consultation with [SCI] and the [SCG or SCO].
Should an agent derived from the compound eventually be licensed to a
pharmaceutical company for production and marketing, DTP/NCI will require thesuccessful licensee to negotiate and enter in to agreement(s) with the appropriate [SCG
agency(ies) or SCO].  This agreement will address the concern on the part of the
[SCG or SCO] that pertinent agencies, institutions and/or persons receive royalties
and other forms of compensation, as appropriate.
(13) DTP/NCI may send selected samples to other organizations for investigation of their
anti-cancer, anti-HIV or other therapeutic potential.  Such samples will be restrictedto those collected by NCI contractors unless specifically authorized by the [SCG or
SCO].  Any organization receiving samples must agree to compensate the [SCG or
SCO] and individuals, as appropriate, in the same fashion as described in
Articles 8-10 above, notwithstanding anything to the contrary in Section 11.
The role of the Source Country Government  ("SCG") or Source Country Organization(s)
("SCO") in the collaboration will include the following:
(1) The appropriate agency in [SCG or SCO] will collaborate with Contractor in the
collection of plants, microbes and marine macro-organisms, and will work with
Contractor to arrange the necessary permits to ensure the timely collection and exportof materials to DTP/NCI.
(2) Should the appropriate agency in [SCG or SCO] have any knowledge of the
medicinal use of any plants, microbes a nd marine macro-organisms by the local
population or traditional healers, this information will be used to guide the collectionIP/C/W/341
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of plants, microbes or marine macro-organisms on a priority basis where possible.
Details of the methods of administration (e.g., hot fusion, etc.) used by the traditional
healers will be provided where applicable to enable suitable extracts to be made.  All
such information will be kept confidential by DTP/NCI until both parties agree to
publication.
The permission of the traditional healer or community will be sought before
publication of their information, and proper acknowledgment will be made of their
contribution.
(3) The appropriate agency in [SCG or SCO] and Contractor will collaborate in the
provision of further quantities of active raw material if required for development
studies.
(4) In the event of large amounts of raw material being required for production, the
appropriate agency of the [SCG or SCO] and Contractor will investigate the mass
propagation of the material in [Source Country].  Consideration should also be given
to sustainable harvest of the material while conserving the biological diversity of the
region, and involvement of the local population in the planning and implementationstages.
(5) [SCG or SCG] and SCI scientists and th eir collaborators may screen additional
samples of the same raw materials for other biological activities and develop them for
such purposes independently of this agreement.
This agreement shall be valid as of the date of the final authorized signature below for an
initial period of five (5) years, after which it can be renewed by mutual agreement.  It may be
amended at any time subject to the written agreement of both parties.  Copies of such amendments
will be kept on file at both of the addresses indicated below.
For the National Cancer Institute: For [SCI] or [SCO]:
_______________________ __________________________
Richard Klausner, M.D. Name (typed):
Director, National Cancer Institute Title:
_______________________ __________________________
Date Date
 mailing and contact address: mailing and contact address:Technology Transfer Branch
National Cancer Institute at Frederick
Fairview Center, Suite 502
1003 - W. 7th Street
Frederick, Maryland 21701-8512
USATelephone:  301-846-5465
Facsimile:  301-846-6820
__________