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About
MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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Why This Topic Is Important
Contracts and agreements constitute one of the primary tools of research collaboration and intellectual
property management. In many cases a scientist or member of the faculty does not have the authority to
sign on behalf of their research institution. It may be important to consult with your administration,
technology transfer office, or outside legal counsel regarding specific contracts and agreements.
Key Implications and Best Practices: Setcion 7
Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.
- A public sector institution can use a variety of agreements to both manage and protect intellectual property, regardless of whether that intellectual property is owned by the public sector institution or by licensing partners in the private sector. The key issue is to allow for maximum flexibility whereby institutions can set, or negotiate, the terms that best fit the mission and goals of the institution and the purpose of the partnership.
- Confidentiality agreements are meant to protect sensitive data that one party transfers to another. They do not run counter to public sector missions or to publishing important research findings. Many organizations, including public sector institutions, often have information that is legitimately kept confidential. Such information can include business plans, research proposals, and databases containing business contacts.
- Confidentiality agreements rely on a culture of trust, not a culture of secrecy.
- No agreement will ever be perfect. Technology transfer officers who negotiate agreements that are in keeping with an institution’s policy are making their best effort at getting deals that respect and strengthen the institution’s mission. Your role, however, is to share with those who negotiate agreements all of the relevant information and your insights. In some cases, especially with collaborative research agreements, you may be an integral member of a team that will address issues such as research plans and purpose.
- In most cases, you will not be authorized to sign certain types of agreements without review by counsel or by your technology transfer office. Make sure you know whether or not you are authorized to sign certain agreements.
- Everyone in your group or laboratory should know—and understand—the obligations entered into through certain agreements that affect information, data, and materials used in your laboratory and research program. This is especially important for material transfer agreements and confidentiality agreements.
- You will need to keep track of data and information related to confidentiality agreements. Understand what can and cannot be disclosed and to whom information can be disclosed. If you have questions, do not hesitate to contact your technology transfer office for guidance.
- An MTA should not be viewed as a barrier to materials access. In fact, MTAs are tools for gaining greater access to materials from a wider range of sources (scientists from the public and private sectors, both in your own country and abroad). However, not all clauses in an MTA may be appropriate. Which clauses are appropriate will depend on the circumstances, the purposes of the transfer, and the institution from which the material is being received.
 Abstract
Agreements: A Review of Essential Tools of IP Management
by Richard T. Mahoney, Anatole Krattiger
Abstract:
Public-sector research institutions can use a variety of agreements to protect and manage intellectual property. These agreements are powerful tools to foster competition in the private sector and reduce prices for consumers in developing countries. This chapter provides an overview of the following types of major agreements—confidentiality, material transfer, development (in which the licensee is responsible for further development), co-development (in which two parties collaborate on continued development), and distribution—explains the functions of those agreements, and suggests strategies for their effective use. The chapter also discusses the meaning and usefulness of the standard elements and formulas found in such agreements. It explains the meaning and significance of the terms and language used and discusses such key issues as product liability, fees and royalties, and arbitration. The chapter emphasizes the importance of establishing and maintaining trust when negotiating and implementing agreements.
Abstract
Confidentiality Agreements: A Basis for Partnerships
by Stanley P. Kowalski, Anatole Krattiger
Abstract:
Confidentiality agreements (also called nondisclosure agreements, confidential disclosure agreements, and secrecy agreements) are contracts that govern the disclosure of confidential information by one party (the disclosing party) to another party (the receiving party). Confidential information is exchanged for a promise of secrecy. The disclosure may be unilateral, bilateral or multilateral. Confidential information disclosed in a confidentiality agreement might pertain to scientific research results and data, chemical compositions and formulas, software development information, recipes, laboratory methodology, and manufacturing techniques trade secrets (in the form of valuable know-how and/or show-how). The confidential information has value precisely due to the fact that is known to only a few, that is, open disclosure will be injurious to this value. Confidentiality agreements often precede licensing negotiations or the acquisition of IP (intellectual property) rights and serve to strike an appropriate balance between the needs of the disclosing and receiving parties. A confidentiality agreement can either stand alone or be included as part of a broader agreement. An appropriately drafted confidentiality agreement should contain a list of standard provisions and exceptions. In special cases, where the disclosing party wishes to carefully protect the confidential information, the agreement might also include extra strong clauses and articulated security provisions.
Abstract
How to Draft a Collaborative Research Agreement
by Martha Bair Steinbock
Abstract:
A collaborative research agreement has five major parts: (1) statement of objectives, (2) statement of work, (3) general provisions, (4) budget, and (5) list of materials. This chapter provides a step-by-step discussion of the issues that need to be addressed in each part of the agreement, emphasizing the importance of crafting an agreement that is mutually beneficial and, above all, clearly written. Whereas all parts of any agreement are important, for collaborative research agreements, extra care should be taken in describing the objectives and work of the collaboration, the research plan, and the mechanisms for agreeing on changes in the research plan. Partnerships grow and change; this invariably leads to the need for amendments. Arguably, many of the best collaborative research agreements need numerous amendments in order to reflect the evolving needs of the parties involved.
Abstract
Specific Issues with Material Transfer Agreements
by Alan B. Bennett, Wendy D. Streitz, Rafael A. Gacel
Abstract:
In the health and agricultural sciences, biological materials were once freely and widely exchanged. But more and more, these materials have gained commercial value. Public sector institutions, as well as private companies, have recognized, therefore, that proprietary protection of these materials may be necessary. Material transfer agreements (MTAs) are legal instruments that define terms for the transfer of tangible biological materials between or among two or more parties. MTAs are bailments that transfer possession but not title: the party who transfers the materials retains full ownership; the party who receives the materials holds them in trust. Transfer is governed by contract, ideally specifying the term of the transfer, how the materials may and may not be used, and other related issues, such as confidentiality. In addition, an MTA may contain licensing provisions for the transfer of embedded intellectual property (IP) rights (patent rights). Hence, an MTA can be a hybrid instrument, covering the transfer of both tangible property (via bailment and contract) and intangible property (via licensing of patent rights). Biological materials transferred using MTAs include reagents, cell lines, antibodies, research tools, insertional mutant populations, genome sequence databases, novel vectors, and plant genetic resources. Due to divergent institutional priorities, material transfers between the private and public sectors are generally more complex than those between public sector institutions.
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