When granting exclusive rights, it is important that the licensor sets out any restrictions and restrictions that the licensor may wish to impose with respect to the scope of the grant. As a general rule, the university licensor will withdraw certain elements of the rights it grants to an industrial partner. Such carve-outs are often necessary for the institution to meet its obligations to the government and Bayh-Dole`s funding agencies, as well as under the conditions of many federal grants. For example, the National Institutes of Health (NIH) has issued formal guidelines to ensure that institutions receiving NIH funding set appropriate conditions in their agreements to ensure access to and dissemination of research tools developed during that research (Federal Register 1999). In general, a number of institutions have approved guidelines to ensure that academic institutions are part of the licensing of their technology (AUTM 2007). Option agreements or option clauses in research agreements describe the conditions under which the university retains the possibility for a third party to negotiate an intellectual property license. Option clauses are often made available to research sponsors of companies as part of a sponsored research agreement or concluded with third parties who wish to evaluate the technology before entering into a licensing agreement. Common steps include the first commercial delivery or sale of the licensed product, the final approval by the Food and Drug Administration of an identified biologcs license application, the conclusion of a financing transaction in which a certain amount of money is collected, and the achievement of certain sales targets for a defined period of time or until a specified date. Performance bricks are those that can be fulfilled with a reasonably foreseeable degree of commercial diligence and are described in such a way that both parties know and understand unambiguously by whom the milestone was reached and what day. An exclusive license generally means that only the licensee can exercise the rights provided for in the contract, including to the exclusion of the IP holder. Exclusivity generally includes the ability to enforce IP rights granted to others. For example, the exclusivity of a patent license generally offers the licensee the opportunity to sue third parties for patent infringement and also allows the licensee to sublicense all or part of its patent rights to others. Exclusive rights play a central role in the development and commercialization of molecular targets and drug candidates, as considerable costs and effort are required to overcome the many risks associated with drug development.
Licensed patent rights play a central role in the value and structure of a licensing agreement, whether simple or complex. Tracking licensed claims (i.e. the process of creating and filing claims and interacting with the Patent Office) requires precise technical thinking and drafting and it is essential that lawsuits are handled with care and care. Although it is customary for the academic licensor to retain control of law enforcement activities because of its legitimate interest in protecting its rights, an exclusive licensee also has a considerable financial interest in the extent of the rights sought and obtained – and may also be responsible for paying at least part of the costs necessary for the grant and maintenance of the patent. As a general rule, business licensors will at least want to check and comment on communication with the Patent Office that affects the scope of claims. Therefore, an exclusive licensee normally requires at least some right of scrutiny – if not full control or veto – over how and where patent rights are sought. . . .