Development Regulatory Clause Samples
The DEVELOPMENT; REGULATORY clause outlines the responsibilities and procedures related to the development of a product or service and the compliance with applicable regulatory requirements. It typically specifies which party is responsible for obtaining necessary permits, approvals, or licenses, and may detail the process for reporting progress or regulatory issues. This clause ensures that both parties understand their obligations regarding regulatory compliance, thereby reducing the risk of legal or operational delays due to unmet regulatory standards.
Development Regulatory. Subject to Section 2.4, SYNTA shall transfer to ROCHE all Development responsibility with respect to a Licensed Compound, on a Licensed Compound-by-Licensed Compound basis, once the relevant Collaboration Compound is designated a Licensed Compound or, if SYNTA is undertaking any Development activities with respect to such Licensed Compound in accordance with Section 2.4, once SYNTA’s activities with respect to a GLP Toxicology Study or Phase 1 Clinical Trials for such Licensed Compound are complete, in accordance with a transition plan to be established by the Parties, including the transfer to ROCHE of any IND or other regulatory filings with respect to such Licensed Compound that are held by SYNTA in SYNTA’s name. Notwithstanding the foregoing, for the First Licensed Compound, such transition shall occur promptly following completion of the first Phase 2a Clinical Trial, if such Clinical Trial is conducted by SYNTA, or promptly following completion of Phase 1 Clinical Trials, if SYNTA does not conduct the first Phase 2a Clinical Trial. Each Party shall continue to use Commercially Reasonable Efforts to perform critical Development activities which may be assigned to such Party under the relevant Development Plan, in a manner consistent with the transition plan, until the completion of such transfer of Development responsibility to ROCHE.
Development Regulatory. 12 (e) Prior to concluding any final Program Acquirer Agreement with a potential Program Acquirer, OV shall disclose such potential Program Acquirer to LP and AFC including supplying an unredacted copy of all proposed contracts and documents governing the transfer to the potential Program Acquirer (the ability to withhold such consent being the “Veto Right”). Such consent shall not be unreasonably withheld, conditioned, or delayed; provided that the Program Acquirer is not insolvent and/or has not filed for bankruptcy within any state, province, country or territory within the Territory and has at least [***] dollars ($ [***] ) in cumulative proven sales of a pharmaceutical product. See Section 5.3 with regard to OV’s obligations towards LP in the negotiation of Program Acquirer Agreement(s)
Development Regulatory. 5.1. Collaboration Programs
Development Regulatory