Regulatory Responsibilities and Costs. As between the Parties, Company shall have sole responsibility for, and shall bear the cost of preparing, all regulatory filings and related submissions with respect to the Licensed Compounds and/or Licensed Products. Except as set forth in Article 13, Company shall own all INDs, Approvals and submissions in connection therewith and all Approvals shall be obtained by and in the name of Company.
Regulatory Responsibilities and Costs. As between the Parties, prior to Celgene’s exercise of a Celgene Program Option with respect to any Program, GlobeImmune shall prepare, file, maintain, and own all Regulatory Filings and related submissions with respect to each such Program and shall bear the cost of such preparation, filing, maintenance, and ownership, until the transfer, if any, to Celgene of such Regulatory Filings for any compound within such Program upon exercise by Celgene of the Celgene Program Option for such Program as provided in Section 4.2.4. Upon request, GlobeImmune will provide the JRC and Celgene with copies of all Regulatory Filings and related correspondence submitted to Regulatory Authorities or received from Regulatory Authorities with respect to such Program.
Regulatory Responsibilities and Costs. Promptly after Celgene’s exercise of a Celgene Program Option, and to the extent permitted under any applicable agreement set forth on Schedule A or Schedule B as of the Effective Date, GlobeImmune shall (a) assign to Celgene any Regulatory Filings for the relevant Celgene Development Compound(s) and, (b) upon Celgene’s request, assign to Celgene any clinical trial or other subcontractor agreements relating solely to such Celgene Development Compound(s) or the portion thereof that relates solely to such Celgene Development Compound(s). Following exercise of a Celgene Program Option, Celgene shall prepare, file, maintain, and own all Regulatory Filings and related submissions relating to the relevant Celgene Development [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Compound(s). Upon the request of GlobeImmune, Celgene shall provide GlobeImmune with copies of material Regulatory Filings and related material correspondence submitted to Regulatory Authorities or received from Regulatory Authorities with respect to any such Celgene Development Compound. Celgene shall have responsibility for, and shall prepare, all Regulatory Filings and related submissions with respect to such Celgene Development Compound(s). At Celgene’s election, following exercise of the Celgene Program Option with respect to a Celgene Development Compound, Celgene may elect to be responsible for all safety reporting obligations globally with respect to such Celgene Development Compound and to take over and maintain the global safety database for such Celgene Development Compound.
Regulatory Responsibilities and Costs. [*] shall be responsible for all safety reporting obligations globally with respect to such Licensed Vaccine and/or Licensed Product included in any Regulatory Filing and shall maintain the global safety database for such Licensed Vaccine and/or Licensed Product.
Regulatory Responsibilities and Costs. Other than as provided in Section 4.1, Gilead shall be responsible for obtaining all Regulatory Approvals and preparing,
Regulatory Responsibilities and Costs. Retrophin [***]. Retrophin shall be responsible for meeting the requirements of all pre-approval inspections required by any Regulatory Authorities. Except as set forth in Section 13.4, Retrophin or its Affiliate or Sublicensee shall own all INDs, NDAs, Approvals and submissions in connection therewith and all Approvals shall be obtained by and in the name of Retrophin or its Affiliate or Sublicensee.
Regulatory Responsibilities and Costs. As between the Parties, Eiger shall have sole responsibility for, and shall bear the cost of preparing, all regulatory filings and related submissions with respect to the Licensed Compounds and/or Licensed Products. Except as set forth in Article 13, Eiger shall own all INDs, Approvals and submissions in connection therewith and all Approvals shall be obtained by and in the name of Eiger.
Regulatory Responsibilities and Costs. Promptly after Monopar’s exercise of the Monopar Validive Option, Onxeo shall (a) assign to Monopar all Regulatory Filings for Licensed Products and, (b) upon Monopar’s request, assign to Monopar all clinical trial or other subcontractor agreements relating solely to Licensed Products. Following exercise of the Monopar Validive Option, Monopar shall prepare, file, maintain, and own all Regulatory Filings and related submissions relating to Licensed Products. Monopar shall have responsibility for, and shall prepare, all Regulatory Filings and related submissions with respect to Licensed Products. At Monopar’s election, following exercise of the Monopar Validive Option, Monopar shall be responsible for all safety reporting obligations globally with respect to such Licensed Products, and to take over and maintain the global safety database for Licensed Products.
Regulatory Responsibilities and Costs. As between the Parties, Merck shall prepare, file, maintain and own all Regulatory Filings and related submissions with respect to all Therapeutic Products and shall bear the cost of such preparation, filing, maintenance and ownership. As between the Parties, Merck shall be solely responsible for communicating with the FDA and/or any other Regulatory Authority in any country or jurisdiction regarding all Therapeutic Products.
Regulatory Responsibilities and Costs. TMC will have the sole responsibility for, and will bear the cost of preparing, all regulatory filings and related submissions with respect to Products (it being understood that TMC may satisfy such responsibilities itself or through its Affiliates and Sublicensees). Promptly after the Effective Date, the Parties will work together to transfer and assign to TMC the Regulatory Documents.
