Access to Regulatory Filings. QMT, its Affiliates, and its respective sublicensees shall have access in a timely manner to all data contained or referenced in such submissions or applications for Regulatory Approvals by DERMA, 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 Exclusive Territory or Products in the Field and outside the Exclusive Territory. DERMA shall provide appropriate notification of such right of QMT to the Regulatory Authorities. QMT, its Affiliates, and its respective sublicensees shall have the right to cross-reference and make any other use of the other DERMA’s Regulatory Filings for the Product, including access to all data contained or referenced in such Regulatory Filings.
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. 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. 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. 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. (a) Licensee shall promptly provide to Dermavant true and complete accurate English translations of all INDs and XXXx (to the extent newly generated by or on behalf of Licensee or its Affiliates or Sublicensees) 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 Dermavant Rights of Reference to all such Product Filings for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Compound and Product in the Dermavant Territory; (ii) obtaining and maintaining Regulatory Approvals for any product incorporating 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 a certified 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 Dermavant’s regulatory purposes, then on Dermavant’s written request, Licensee will, as soon as practicable seek and obtain such certified English translation, and provide such certified English translation to Dermavant, provided that Dermavant will be responsible for reimbursing Licensee for [***] of the costs reasonably incurred by Licensee in connection with obtaining such certified English translations, which amounts shall be paid by Dermavant within [***] following Dermavant’s receipt of an invoice for any such undisputed amounts.
(b) Dermavant shall promptly provide to Licensee true and complete copies of all Product Filings for Product filed by or on behalf of Dermavant or its Affiliates or Sublicensees in the U.S. or with the European Medicines Agency (or any successor agency). Dermavant 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 Product for use or distribution in the Field in the Territory under the Manufacturing License, following the grant of such Manufacturing License, if applicable, and (iii) complying with applicable pharmacovigilance and other regulatory requi...
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. NOVACEA shall provide to XXXXXX XXXXX 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. 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 VIRIDIS, 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 VIRIDIS’s Regulatory Filings for the Product, including access to all data contained or referenced in such Regulatory Filings.
Access to Regulatory Filings. (i) ANTHERA shall promptly provide to ZENYAKU true and complete copies of all B.L.A.s, DMFs, Regulatory Approvals and other filings and submissions to Regulatory Authorities regarding Compound or Product in the Field in the ANTHERA Territory, and hereby grants to ZENYAKU, without exception, the right to cross-reference and access all such B.L.A.s, DMFs, Regulatory Approvals, filings and submissions for the purposes of obtaining and maintaining Regulatory Approvals for the Product in the ZENYAKU Territory and complying with applicable pharmacovigilance and any other regulatory requirements relating to the Product in the ZENYAKU Territory.
(ii) ANTHERA shall, promptly upon request of ZENYAKU, file with applicable Regulatory Authorities such letters of cross-reference and access as may be necessary to accomplish the intent of this Section 4.7(b). *** Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission.
