Access to Regulatory Filings Clause Samples

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. Acucela and Otsuka shall each have a right to cross reference or incorporate by reference any Regulatory Filings or drug master file (and any Data contained therein) for Collaboration Products made in any country in the Shared Territory (including all Regulatory Approvals) to support Regulatory Filings for Collaboration Products in each Party’s Sole Territory and to enable either Party to fulfill its obligations or exercise its rights granted or retained under this Agreement. In addition, in each agreement with an Affiliate or Third Party involving Data with respect to a Collaboration Product in the Field in the Shared Territory, the contracting Party shall require that such Affiliate or Third Party provide such Party with access to all such Data as is necessary or useful to be obtained for purposes of Regulatory Approvals.

Access to Regulatory Filings. Tracon hereby grants to Santen (and its Affiliates and Sublicensees, as applicable) the right to access and cross-reference filings made by Tracon or its Affiliates, by Tracon’s licensors or suppliers (who have granted Tracon cross-

Access to Regulatory Filings. If this Agreement terminates in accordance with Article 10.2, 10.3 (on account of breach by Licensee) or 10.4, Licensee shall provide to DUKE within [**] days after such termination, at Licensee’s expense, one copy of (a) all market clearance applications described in Article 9.1 (including all data and documentation submitted therewith) relating to a Licensed Product and (b) all data, and documentation related to the data, that relate to any other regulatory filings, approvals, reports, records, or correspondence for a Licensed Product, if and to the extent that the provision of, access to and delivery of such applications, data, documentation and other materials to DUKE shall be consistent with Licensee’s obligations under contract and applicable law and its officers’ and directors’ fiduciary obligations.

Access to Regulatory Filings. QMT and its Affiliates shall have access in a timely manner to all data contained or referenced in such submissions or applications for Regulatory Approvals by BIOSARA, including all reports, correspondence and conversation logs, in each case as may be reasonably necessary to enable QMT to develop, manufacture and Commercialize products outside the Field in the Territory or Products in the Field and outside the Territory. QMT and its Affiliates shall have the right to cross-reference and make any other use of the other BIOSARA’s Regulatory Filings for the Product, including access to all data contained or referenced in such Regulatory Filings.

Access to Regulatory Filings. (a) Licensee shall promptly provide to Verrica true and complete copies of all INDs and ▇▇▇▇ for Product filed by or on behalf of Licensee or its Affiliates or Sublicensees with Regulatory Authorities in the Territory and all Regulatory Approvals received for Product from Regulatory Authorities in the Territory. Licensee hereby grants to Verrica Rights of Reference to all such Product Filings for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Compound and Product in the Verrica Territory; (ii) obtaining and maintaining Regulatory Approvals for any product incorporating the Compound (other than Product) in the Territory; (iii) the manufacture of Compound or Product for use or distribution anywhere in the world; and (iv) complying with applicable pharmacovigilance and other regulatory requirements with respect to the Product and activities described in the preceding clauses (i) through (iii). Without limiting the foregoing, if an English translation of any IND or MAA filed by or on behalf of Licensee in the Territory for the Product or Compound is reasonably necessary for Verrica’s regulatory purposes, then on Verrica’s written request, Licensee will, as soon as practicable seek and obtain such English translation (to the extent newly generated by or on behalf of Licensee or its Affiliates or Sublicensees), and provide such English translation to Verrica, provided that Verrica will reimburse Licensee for [***] of the external costs reasonably incurred by Licensee in connection with obtaining such English translation, which amounts shall be paid by Verrica within [***] following Verrica’s receipt of an invoice for any such undisputed amounts. (b) Verrica shall promptly provide to Licensee true and complete copies of all Product Filings for Product filed by or on behalf of Verrica or its Affiliates in the United States or with the European Medicines Agency (or any successor agency). Verrica hereby grants to Licensee the Rights of Reference to all such Product Filings for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Product in the Field in the Territory; (ii) manufacturing the Product for use and distribution in the Field in the Territory under the Manufacturing License, if applicable; and (iii) complying with applicable pharmacovigilance and other regulatory requirements with respect to Product in the Territory. (c) Each Party shall, promptly upon request of the other Party, file with applicable Regulatory Au...

Access to Regulatory Filings. NOVACEA shall provide to ▇▇▇▇▇▇ ▇▇▇▇▇ on a timely manner, access to copies of all regulatory filings submitted by it to a Regulatory Authority in the NOVACEA Territory for any Licensed Product or Improvement.

Access to Regulatory Filings. Consistent with the requirements of ▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇ will provide to NEUROGEN the complete IND file for Aplindore (“Original IND”) including all supplements to the Original IND, all regulatory files and FDA correspondence related thereto, and all records and reports required to be kept that are necessary to effect the transfer of the IND and allow NEUROGEN to pursue development of the Compound (but excluding, for the avoidance of doubt, records of WYETH that are not necessary for such purposes such as confidential personnel records or facility design records). Within ten (10) days after NEUROGEN confirms in writing the receipt of the Original IND from WYETH, WYETH will execute and deliver a letter to the FDA authorizing the transfer of ownership of the Original IND to NEUROGEN. NEUROGEN will promptly thereafter take all further actions that are necessary to transfer ownership of the Original IND for Aplindore to NEUROGEN. WYETH shall use reasonable and diligent efforts to ensure that it has located and provided to NEUROGEN all such documentation related to the Original IND and all other Licensed Know-How and Aplindore Licensed Know-How and WYETH shall promptly convey to NEUROGEN any such documentation or other Licensed Know-How, or Aplindore Licensed Know-How that WYETH locates after the Effective Date. WYETH also agrees to provide reasonable assistance to ensure a prompt and complete transfer by the FDA of ownership of the IND to NEUROGEN. Following the effective transfer of ownership of the IND to NEUROGEN, NEUROGEN will assume sole regulatory responsibility for development of Aplindore,

Access to Regulatory Filings. Hanmi hereby grants to Spectrum (and its Affiliates and Sublicensees, as applicable) the right to access and cross-refer to filings made by Hanmi or its Affiliates, by ▇▇▇▇▇’s licensors or suppliers (who have granted ▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ rights to their filings, which ▇▇▇▇▇ will use Commercially Reasonable Efforts to obtain), and by licensees (who have agreed to reciprocal rights of reference for the benefit of Hanmi, which Hanmi will use Commercially Reasonable Efforts to obtain) with Regulatory Authorities and Marketing Approval relating to the Compound and/or the Product (including any DMF) solely to the extent necessary in connection with regulatory activities with respect to the Products in the Field in the Spectrum Territory. Spectrum hereby grants to Hanmi and its Affiliates and licensees (who have agreed to reciprocal rights of reference for the benefit of Spectrum, which Spectrum will use Commercially Reasonable Efforts to obtain) the right to access and cross-refer to filings made by Spectrum and its Affiliates and Sublicensees and by Spectrum’s licensors or suppliers (who have granted Spectrum cross-reference rights to their filings, which Spectrum will use Commercially Reasonable Efforts to obtain), with Regulatory Authorities and Marketing Approval relating to the Products (including any DMF) solely to the extent necessary in connection with regulatory activities with respect to the Products in the Field in the Hanmi Territory. Each Party shall, promptly upon request of the other Party, file with applicable Regulatory Authorities such letters of access or cross-reference as may be necessary to accomplish the intent of this Section 3.2(b).