Common use of Regulatory Responsibilities and Costs Clause in Contracts

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. 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 24b-2 of the Securities Exchange Act of 19331934, 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.