Generic Event Marketability and Access Agreement (GEMAA)
The GEMAA: Path Forward for Generic Biotechnology Events
Under the GEMAA, companies that have developed proprietary regulatory information to support the authorizations for events globally, called “Proprietary Regulatory Property (PRP) Holders”, must provide access to the generic event at patent expiration. PRP Holders are required to provide notice of patent expiration three years before the last patent on the biotechnology event expires. At the point of the notice of patent expiration, the PRP Holder has a choice to:
- Independently maintain regulatory responsibility for the event at no cost to users of the generic event
- Seek to share regulatory responsibility; or
- Discontinue regulatory responsibility
Independently Maintain Regulatory Authorizations.
Companies that choose to independently maintain regulatory responsibilities must maintain global regulatory authorizations at no cost to user of the event until they seek to share or choose to discontinue. Under this option, PRP Holders are not mandated to provide access to the proprietary regulatory package for purposes of new product development, such as seed products containing proprietary stacks.
Seek to Share Regulatory Responsibility
The PRP Holder may seek to share regulatory responsibility for a biotechnology event, in which case the PRP Holder and interested Signatories to the GEMAA would begin negotiation of a “joint responsibility agreement”. Once concluded, this agreement would provide full access to the PRP. If there are unresolved issues in this negotiation, they would be submitted to binding arbitration. No party to the negotiation, however, is required to accept the arbitration ruling. If the joint responsibility agreement is not finalized, the PRP holder must either continue to independently maintain authorizations or announce they will discontinue maintenance of these responsibilities and discontinue the event.
Discontinue Maintenance of Regulatory Responsibility
If a PRP Holder decides to discontinue regulatory responsibilities, a seven year clock is started which concludes when the PRP holder discontinues regulatory responsibilities for the biotechnology event. Like the shared responsibility agreement, the announcement to discontinue begins a negotiation of a “transition agreement” with the same timeline and process as the joint responsibility agreement, including binding arbitration for unresolved issues in the negotiation. Unlike the joint responsibility agreement, the PRP holder must execute the transition agreement. If no other signatory involved in the negotiation signs the transition agreement, the PRP Holder and all other signatories must discontinue the event within the seven year period initiated by the notice to discontinue regulatory responsibilities.
Cost of signing the GEMAA
The agreements were designed to keep operating costs minimal. Costs associated with signing the GEMAA are limited to the annual operating costs of the GEMAA from which small business entities and non-profit 501(c)3 corporations are exempt. If a company signs the GEMAA and currently is involved in utilizing seed products containing biotechnology events, they only take on a commitment to appropriately steward those products. Should a Signatory choose to execute a joint responsibility or transition agreement for a specific event, that Signatory will take on the responsibility to steward that event as well as their share of regulatory costs associated with that event.
Administration of the GEMAA
The GEMAA will be overseen by a Committee of Signatories that will have the duty to carry out the discretionary duties of the GEMAA. Participation on the Committee of Signatories is voluntary. The day-to-day non-discretionary functions of the GEMAA will be managed by an Administrator, who will serve as the point of contact for Signatories, prospective signatories and the public.
Implementation of the GEMAAThe GEMAA will be effective once it has four signatories. Once effective, the Committee of Signatories will be formed within three months, and the first meeting of the Committee will held within three months.