Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all Regulatory Materials pertaining to Licensed Products submitted by or on behalf of such Party. The receiving Party may use such right of reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of Licensed Products in its respective territory. Each Party shall support the other Party, as reasonably requested by such other Party and at such other Party’s expense, in obtaining Regulatory Approvals in such other Party’s territory, including providing necessary documents or other materials required by applicable Laws to obtain Regulatory Approval in such territory, all in accordance with the terms and conditions of this Agreement.
Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all Regulatory Filings pertaining to the Compound and Products submitted by or on behalf of such Party. The receiving Party may use such right of reference solely for the purpose of seeking, obtaining, and maintaining Regulatory Approval of the Products for use in its territory in accordance with this Agreement. Notwithstanding the foregoing, the receiving Party has such right of reference to any Regulatory Filings based on Data resulting from the other Party’s Independent Work only to comply with its safety reporting obligations, unless the receiving Party pays the other Party for such work as set forth in Section 8.2(b).
Right of Reference to Regulatory Materials. Licensee hereby (a) grants to Licensor a right of reference to all Regulatory Materials filed by or on behalf of Licensee in the Licensee Territory, which right of reference Licensor may use for the sole purpose of seeking, obtaining and maintaining Regulatory Approvals and Developing and Commercializing (i) the Products in the Licensor Territory and (ii) product for any Indications other than the Licensed Indications anywhere in the world (including the Licensee Territory) and (b) agrees to provide copies of such Regulatory Materials, Regulatory Approvals and all corresponding documentation to Licensor as soon as practicable after Licensee’s submission to Regulatory Authorities. Licensee shall promptly submit any necessary notices or authorizations to Regulatory Authorities that are necessary to effect such rights of reference. Licensee shall support Licensor, as reasonably requested by Licensor, in obtaining Regulatory Approvals in Licensor’s Territory, including providing necessary documents or other materials required by Laws to obtain Regulatory Approval in Licensor’s Territory.
Right of Reference to Regulatory Materials. GSK will and hereby does, and will cause its Affiliates and its and their Sublicensees to, (i) effective as of the effective date of termination, assign to Surface all of its rights, title, and interests in and to all Regulatory Materials, filings for Pricing and Reimbursement Approval, Regulatory Approvals, Clinical Data and other material documentation, to the extent allowed under applicable Law and solely related to the Licensed Antibodies or Licensed Products that are then held by or owned or controlled by GSK or any of its Affiliates or Sublicensees and (ii) to the extent assignment pursuant to clause (i) is not permitted by applicable Law or not solely related to the Licensed Antibodies or Licensed Products that are then held by or owned or controlled by GSK or any of its Affiliates or Sublicensees, GSK will and hereby does grant to Surface an exclusive right of reference to such Regulatory Materials, filings for Pricing and Reimbursement Approval, Regulatory Approvals, Clinical Data and other material documentation, to the extent allowed under applicable Laws, for the Licensed Antibodies or the Licensed Products that are then held by or owned or controlled by GSK or any of its Affiliates or its or their Sublicensees for the continued Development and Commercialization thereof by Surface.
Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all Regulatory Materials pertaining to the Licensed Product in the Field submitted by or on behalf of such Party. Servier may use such right of reference to [*] = 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. Miragen’s Regulatory Material in the Field solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Licensed Products in Field in the Territory. Miragen may use the right of reference to Servier’s Regulatory Material in the Field solely for the purpose of seeking, obtaining and maintaining regulatory approval of the Licensed Products outside the Territory. Notwithstanding the foregoing, each Party may use the right of reference to any Regulatory Materials based on data resulting from the Unsponsored Work conducted by the other Party only to comply with the regulatory requirements (in particular with respect to safety reporting) in such Party’s territory, unless such Party reimburse the other Party a portion of the Unsponsored Work Development Costs as set forth in Section 5.4(c).
Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all Regulatory Filings pertaining to the Compound and Products submitted by or on behalf of such Party. The receiving Party may use such right of reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Products for use in its territory in accordance with this Agreement. Notwithstanding the foregoing, the receiving Party may use such right of reference to any Regulatory Filings based on Data resulting from the other Party’s Independent Work only to comply with its safety reporting [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. obligations, unless the receiving Party pays the other Party for such work pursuant to Section 9.2(c).
Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all Regulatory Filings pertaining to the Compound and Products submitted by or on behalf of such Party. The receiving Party may use such right of reference solely for the purpose of seeking, obtaining, and maintaining Regulatory Approval of the Products for use in its territory in accordance with this Agreement. Notwithstanding the foregoing, the receiving Party has such right of reference to any Regulatory Filings based on [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Data resulting from the other Party’s Independent Work only to comply with its safety reporting obligations, unless the receiving Party pays the other Party for such work as set forth in Section 8.2(b).
Right of Reference to Regulatory Materials. (including relevant portions of Drug Master Files). Each Party hereby grants to the other Party the right of reference to all Regulatory Materials pertaining to Licensed Products submitted by or on behalf of such Party. The receiving Party may use such right of reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of Licensed Products in its respective territory. Each Party shall support the other Party, as reasonably requested by such other Party and at such other Party’s expense, in obtaining Regulatory Approvals in such other Party’s territory, including providing necessary documents or other materials required by applicable Laws to obtain Regulatory Approval in such territory, all in accordance with the terms and conditions of this Agreement.
Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all Regulatory Materials pertaining to Licensed Products submitted by or on behalf of such Party, subject to the limitations set forth in Section 4.7 that there is no guarantee that Data generated from a non-clinical or clinical study in the Hansoh Territory will satisfy the requirements of another Regulatory Authority in the Keros Territory. If Hansoh elects to participate in a Global Clinical Trial, the Parties shall ensure that any Data generated in the Hansoh Territory shall satisfy the requirements of the Regulatory Authority in the Hansoh Territory for the right of reference. The receiving Party may use such right of reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of Licensed Products in its respective Territory. Each Party shall support the other Party, as reasonably requested by such other Party [***], in obtaining Regulatory Approvals in such other Party’s Territory, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approval in such Territory, all in accordance with the terms and conditions of this Agreement. [***].
Right of Reference to Regulatory Materials. Company hereby grants KemPharm the right of reference to all Regulatory Materials pertaining to the Products submitted by or on behalf of Company, its Affiliates and its Sublicensees. KemPharm may use such right of reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of any Additional Product or ROFR Product for which Company has not elected to exercise the Additional Product Option or Right of First Refusal, respectively, both inside and outside the Territory.
