Common use of Access to Regulatory Filings Clause in Contracts

Access to Regulatory Filings. Each Party and its Affiliates, and, subject to such Party's obligations to Third Parties, its Sublicensees, shall have the right to refer to, access, cross reference, and use documents relating to each Collaboration Product filed by a Party or its Affiliates or Sublicensees with regulatory entities with respect to activities conducted in connection with the Research Program or the Development, including clinical studies and other supporting information, and any written communications to and with the FDA and other comparable Agencies. GenVec (and its designees) shall have access to and the right to the Data Package for use in connection with regulatory filings for (i) Collaboration Products, outside the Co-Promotion Countries and the Territory, and (ii) with respect to Product Configurations (and corresponding Collaboration Products) for which Warner does not retain rights under this Agreement, and other products, outside and within the Territory and Co-Promotion Countries. It is understood and agreed that GenVec shall not provide access to the Data Package or other data generated in connection with the Research Program or with respect to the Development of a Development Candidate (or corresponding Collaboration Product) to the Asian Partner unless the Asian Partner agrees to pay the amounts described in Section 2.2.3.

Access to Regulatory Filings. Each Party and its Affiliates, and, ---------------------------- subject to such Party's obligations to Third Parties, its Sublicensees, shall have the right to refer to, access, cross reference, and use documents relating to each Collaboration Product filed by a Party or its Affiliates or Sublicensees with regulatory entities with respect to activities conducted in connection with the Research Program or the Development, including clinical studies and other supporting information, and any written communications to and with the FDA and other comparable Agencies. GenVec (and its designees) shall have access to and the right to the Data Package for use in connection with regulatory filings for (i) Collaboration Products, outside the Co-Promotion Countries and the Territory, and (ii) with respect to Product Configurations (and corresponding Collaboration Products) for which Warner does not retain rights under this Agreement, and other products, outside and within the Territory and Co-Promotion Countries. It is understood and agreed that GenVec shall not provide access to the Data Package or other data generated in connection with the Research Program or with respect to the Development of a Development Candidate (or corresponding Collaboration Product) to the Asian Partner unless the Asian Partner agrees to pay the amounts described in Section 2.2.3.

Access to Regulatory Filings. Each Party and its Affiliates, and, ---------------------------- subject to such Party's obligations to Third Parties, its Sublicensees, shall have the right to refer to, access, cross reference, and use documents relating to each Collaboration Product filed by a Party or its Affiliates or Sublicensees with regulatory entities with respect to activities conducted in connection with the Research Program or the Development, including clinical studies and other supporting information, and any written communications to and with the FDA and other comparable Agencies. GenVec (and its designees) shall have access to and the right to the Data Package for use in connection with regulatory filings for (i) Collaboration Products, outside the Co-Promotion Countries and the Territory, and (ii) with respect to Product Configurations (and corresponding Collaboration Products) for which Warner does not retain rights under this Agreement, and other products, outside and within the Territory and Co-Promotion Countries. It is understood and agreed that GenVec shall not provide access to the Data Package or other data generated in connection with the Research Program or with respect to the Development of a Development Candidate (or corresponding Collaboration Product) to the Asian Partner unless the Asian Partner agrees to pay the amounts described in Section 2.2.3.. [*]