Common use of Regulatory Affairs Clause in Contracts

Regulatory Affairs. (a) During the Term, VIA shall (i) control and be solely responsible for making all needed Regulatory Filings relating to the development of Licensed Products and for seeking and maintaining Registrations of Licensed Products developed by VIA throughout the Territory, in such countries as it selects; and (ii) own and be responsible for preparing and submitting all Regulatory Rulings, including preparing all applications and reports necessary as part of an IND, NDA, DMF (“Drug Master File”), or other necessary filing required for Registration. Roche shall assign to VIA all rights, title and interest in and to all Regulatory Filings that Roche has made with respect to any Compound or Derivative and all licenses, authorizations and permits that Roche has obtained with respect to clinical trials of any Compound or Derivative. Roche shall permit VIA to access, and shall provide VIA with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all records pertaining to Compounds, Derivatives or Licensed Products as are in the possession of Roche and are reasonably necessary for obtaining Registrations for Licensed Products. (b) In conducting any research or development activities under this Agreement, VIA shall (i) ensure that its employees, agents, clinical institutions and clinical investigators comply with all Regulatory Agency statutory and regulatory requirements with respect to Licensed Products, including but not limited to the Federal Food, Drug and Cosmetic Act, as amended, the Public Health Service Act, Institutional Review Boards, GCP, GLP, IND regulations, and any conditions imposed by a reviewing IRB or Regulatory Agency; and (ii) not utilize, in conducting studies on Licensed Products, any person or entities that at such time are debarred by a Regulatory Agency, or that, at such time, are under investigation by the FDA for debarment action pursuant to the provisions of 21 U.S.C. § 335.

Regulatory Affairs. (a) During the Term, VIA Miikana shall (i) control and be solely responsible for making all needed Regulatory Filings relating to the development of Licensed Products and for seeking and maintaining Registrations of Licensed Products developed by VIA in the Field throughout the Territory, in such countries as it selects; and (ii) own and be responsible for preparing and submitting all Regulatory Rulings, including preparing all applications and reports necessary as part of an IND, NDA, DMF (“Drug Master File”)DMF, BLA or other necessary filing required for Registration. Roche shall assign to VIA Miikana all rights, title and interest in and to all Regulatory Filings that Roche has made with respect to any Compound or Derivative and all licenses, authorizations and permits that Roche has obtained with respect to clinical trials of any Compound or Derivative. Roche shall permit VIA Miikana to access, and shall provide VIA Miikana with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all records pertaining to Compounds, Derivatives or Licensed Products as are in the possession and Control of Roche and are reasonably necessary for obtaining Registrations for Licensed Products. (b) In conducting any research or development activities under this Agreement, VIA Miikana shall (i) ensure that its employees, agents, clinical institutions and clinical investigators comply with all Regulatory Agency FDA statutory and regulatory requirements with respect to Licensed Products, including but not limited to the Federal Food, Drug and Cosmetic Act, as amended, the Public Health Service Act, Institutional Review Boards, GCP, GLP, IND regulations, and any conditions imposed by a reviewing IRB or Regulatory Agencythe FDA; and (ii) not utilize, in conducting studies on Licensed Products, any person or entities that at such time are debarred by a Regulatory Agencythe FDA, or that, at such time, are under investigation by the FDA for debarment action pursuant to the provisions of 21 U.S.C. § 335.