A

A contract

is a voluntary agreement between two or more partners, (most often drawn up as a formal written document) which once signed, becomes binding and enforceable by law on all the partners to the contract

A

A clause

is a stipulation that contains a term/provision in a contract

A

An obligation

is a duty of some kind, described in the contract, that each partner is responsible for performing. This forms the legal bond between the partners to act upon the terms that regulate the collaboration

A

A breach

is the failure to perform any term (obligation or responsibility) of a contract

J

Jurisdiction

is the stipulated choice of law governing the contract (where disputes will be resolved). Thus agreement over which nation, sub-region, state, or county’s courts will have power to make legal decisions and judgments is important when thinking about whose jurisdictional law will be applied

A

A legislative framework

is the overall legal structure which is in place within a jurisdiction

T

The choice of law

can be established at the outset. However, if this is not stipulated in the contract, there is a stage in litigation where, when there is a conflict of laws between two jurisdictions, a reconciliation must be made between the choice of law that are in conflict

I

Indemnification

is included in a contract to protect parties from wrongdoing by third parties

D

Dispute resolution

is a process or procedure of resolving disputes between partners. Dispute resolution avenues include These include arbitration or litigation (or use of courts). On the one hand in arbitration partners can choose to engage in preliminary negotiation or consider mediation, before proceeding to arbitration. On the other hand, parties may prefer to use litigation or the courts for the conduct of the main proceedings

M

Mediation

is a provision that attempts to settle a legal dispute through the active participation of a third party (mediator) who works to find points of agreement

A

Arbitration

is a formal mechanism used to resolve disputes between parties outside the courts. The results of an arbitration process are then considered to be binding

A

A hold-harmless clause

is included when the enabling party to the contract does not want to be held liable for any damages caused as a result of the activities enabled by the contract

A

A warranty clause

is a contractual undertaking/promise on the facts stated in the contract are true or will happen

A

An authorized representative

is an individual who is authorized to act on behalf of another (individual or organisation)

E

Establishing a research contract

that has been negotiated and agreed upon, from the outset, to the benefit of all partners is important. Thus care needs to be taken in developing the terms and conditions of the research contract. The research contract provides a description of expectations and responsibilities of each partner involved. Partners will rely on agreed contract terms and conditions for the duration of the partnership. This will have significant bearing on the enforceability and protection of partner interests, especially if a dispute arises.

R

Research contracts serve to protect

the interests of all partners involved and to legally bind partners to the terms and conditions agreed to in the contract.

Essentially the research contract describes legally binding -
• rights
• obligations
• responsibilities, and
• dispute resolution procedures

The basic assumption is that those entering into the partnership have partly overlapping interests and aim to agree on an equitable collaboration reflecting mutual benefit, trust, respect and good communication.

Thus careful consideration toward the purpose and intended outcomes of the research partnership is very important as it helps to determine what clauses should be prioritized for inclusion in the contract. For example, if IP is an integral part of the research, then clauses relating to intellectual property rights need to be carefully considered.

Disputes often arise in a partnership, thus it is essential that mechanisms and procedures for enforcement of the contract, what costs might be involved and how will these responsibilities be shared, are in place.This will minimise or avoid conflict that could hinder successful collaboration.

D

Depending on the nature of partnership

there are different types of agreements that could serve as a stand-alone agreement or included within a larger contractual arrangement.

The different types of contracts include:
• memorandum of understanding
• memorandum of agreement
• collaborative agreement
• participation agreement
• service agreement
• research agreement
• confidentiality agreement
• non-disclosure agreement
• materials transfer agreement
• access agreement, and
• licensing agreement

P

Partnerships provide a great deal of potential

for building strong research infrastructure in lower income settings. However, such sustainability is only achievable if research funding also allows , for example, for capacity building and sharing of other benefits from research partnerships which leave the low income partner in a stronger position. Low income partners are increasingly asserting their rights to intellectual property and calling for fairer technology transfer arrangements.

A

An agreement forms the basis of a contract

however, not all agreements are contracts. There must be at least two partners to the agreement and obligations on the partners in order for the agreement to be legally enforceable.

CASE STUDY

The African Agricultural Technology Foundation

For smallholder farmers in Africa, yields of major staple crops (maize, sorghum, millet, cassava, cowpea, bananas/plantains) have remained stagnant, or even declined, in the past 40 years.  Numerous biotic and abiotic stresses have contributed to this dire trend. Local research efforts to overcome these stresses have been hampered by declining support for agricultural research, limited access to elite genetic material and other technologies protected by IP rights and the absence of commercial interest in these crops from private owners of agricultural technologies.

The African Agricultural Technology Foundation (AATF) is a new initiative addressing the challenge of reversing the negative trend in agriculture by negotiating access to proprietary technologies and facilitating their delivery to smallholder farmers in Sub-Saharan Africa. AATF believes it is essential and indeed good IP management practice to finalize all contractual terms, set them out in writing, and have an agreement duly signed by the authorized representatives of the parties before commencement of any engagement. Therefore, AATF ensures that all arrangements with third parties associated with the access to or the creation, use, or exploitation of IP protected materials are appropriately documented.

Documentation for the Cowpea Improvement Project, for example, will involve several agreements between AATF and its collaborating partners. First, AATF obtained a license from Monsanto, and thereafter sub-licensed the licensed Bt gene to CSIRO and IITA, in order to introduce the Bt gene into the cowpea genome. The AATF, potentially, will sublicense the resulting successful transgenic events to African agricultural research institutions, which will introgress the Bt gene in cultivated cowpea varieties. These varieties would then be licensed to commercial, non-government, humanitarian or public institutions charged with disseminating the improved cowpea varieties in Africa.
(Access online via http://www.iphandbook.org/handbook/ch17/p18/  on 23 April 2014)

CASE STUDY

The NIPRISAN Case, Nigeria

The NIPRISAN case was a unique project because of the nature regarding the processes followed for the collaborative agreements. The project was led and undertaken by African scientists working in Africa.  The NIPRISAN case highlights how research agreements, between partners, were negotiated when no international provisions for benefit sharing, where commercial products derived from indigenous medical knowledge, existed.

Nigeria’s National Institute for Pharmaceutical Research and Development (NIPRD) prioritized the exploration of indigenous medical knowledge and indigenous biodiversity for the treatment of sickle cell disorder. Sickle Cell Disorder (SCD) is a condition, mostly affecting people with African ancestory, with the highest incident in Nigeria.

NIPRD discovered that Rev. Ogunyale, educated in the United States of America and a traditional medicine practitioner, had been treating patients with SCD with a herbal medicine. The Chief Executive Officer of NIPRD, Professor Wambebe requested discussions with Rev. Ogunyale regarding the possibility of a research collaboration. Rev Ogunyale agreed to the collaboration which then involved a series of negotiations. Building on Rev. Ogunyale’s traditional medicinal knowledge, this would enable NIPRD to develop a commercially available traditional herbal drug, called Niprisan, for the treatment and management of SCD patients.

Negotiations included a Memorandum of Understanding (MOU) which was developed based on a number of steps taken by the partners to ensure a transparent and equitable partnership. The NIPRD sought the assistance of World Intellectual Property Organisation (WIPO) which included the provision of resource materials and Prof. Wambebe attended intellectual property rights (IPR) workshop. Together with the assistance of an NIPRD Legal Adviser, the MOU was drafted. After some further discussions and clarifications with a lawyer, family and traditional medicine practitioner, Rev. Ogunyale and NIPRD agreed on the MOU. The agreement entitled Rev. Ogunyale and his family to benefit the royalties from Niprisan. Rev. Ogunyale would then provide full disclosure of his traditional medicinal knowledge of the plant combinations and methods for the development of NIPRISAN.

‘The MOU developed by the NIPRD for research collaboration with traditional health practitioner has been adopted by both the WHO and the WIPO.’ What is clear from this experience is that fair research collaborations include transparency and trust and a recognition and establishment of benefit-sharing agreements.

Taken from Wambebe, Charles (2007) NIPRISAN Case, Nigeria. A Report for GenBenefit, available at: http://www.uclan.ac.uk/genbenefit.

Reading

Model Agreement between Research Institutes and Traditional Health Practitioners. In: Generic Model Guidelines for Clinical Study of Traditional Medicine in WHO African Region.

World Health Organisation

Research Contracting Course

Praxis Auril

Courses

- No items under this category

Links and Organisations

- No items under this category

Other

Standardized Clauses for Clinical Trial Agreements

National Cancer Institute

Alternative Dispute-Resolution Procedures

IP Handbook

Brunswick Template Agreements

Praxis Unico

Resolving Intellectual Property Disputes

World Intellectual Property Organisation