Letter of Cross-Reference. Promptly, but no later than [***], after the Effective Date, Genentech shall provide to Corvus a letter of cross-reference authorizing Corvus to reference certain information previously provided by Genentech in its INDs for the Genentech Molecule as support for the Combination portion of the Study in accordance with 21 CFR § 312.23(b). Such letter of cross-reference shall remain in full force and effect unless it is withdrawn by Genentech due to termination of this Agreement by a Party.
Letter of Cross-Reference. 3.1 The parties understand and agree that Xxxxx X. Xxxx, Xx. is the holder of the Investigational New Drug ("IND") application set forth and described in Exhibit B, attached. The University shall endeavor to obtain a letter of cross-reference to the IND described in Exhibit B to be executed by Xxxxx X. Xxxx, Xx. for Licensee's use for clinical evaluation of Licensed Technology and for use with any regulatory agency Licensee deems appropriate. University shall endeavor to transfer a letter of cross reference signed by Xxxxx X. Xxxx Xx. to Licensee by sending the original letter to Licensee within thirty (30) days after receipt of written request from Licensee for such a letter.
Letter of Cross-Reference. Promptly, but no later than ten (10) business days, after the Effective Date, Humanigen shall provide to Kite a letter of cross-reference authorizing Kite to reference Humanigen INDs for the Humanigen Investigational Product as reasonably necessary to support the Study under the existing Collaboration IND maintained by Kite. Such letter of cross-reference shall remain in full force and effect until the end of the Term. In addition to Humanigen’s obligations to supply the Humanigen Investigational Product under Section 4.1, Humanigen shall, promptly following Kite’s request, provide and make available to Kite any necessary information about the Humanigen Investigational Product, including without limitation, any Humanigen Confidential Information, to support Kite in obtaining approval to conduct the Study from Regulatory Authorities and IRBs and in conducting the Study. Further, Humanigen shall provide reasonable assistance to Kite to support Kite’s interactions with Regulatory Authorities and IRBs in connection with the Study. Neither Party shall have any rights to use the other Party’s solely owned Confidential Information or Joint Confidential Information, except as otherwise expressly provided in this Agreement, including this Section 2.6(c), Section 5.1(b), Section 5.3(b), Article 7, and Article 8, and such permitted uses do not grant any right or license or transfer ownership to either Party under any of the other Party’s information (including without limitation Confidential Information). Notwithstanding the foregoing, while a Party may have rights to use solely owned Confidential Information or Joint Confidential Information as expressly set forth in this Agreement, in no event shall any Party disclose, disseminate or otherwise share the other Party’s solely owned Confidential Information or Joint Confidential Information with any Third Party except as expressly authorized in Articles 7 or 8, without the express written consent of such other Party.
Letter of Cross-Reference. Orion agrees that the Cross Reference letter dated December 10, 1999 from Orion to GTX shall remain in effect and may not be revoked by Orion unless this Agreement is terminated. During the Term, Orion shall permit GTX, its Affiliates and the GTX Unaffiliated Sublicensees to reference, and shall provide GTX with an appropriate authorization letter to enable GTX, its Affiliates and the GTX Unaffiliated Sublicensees to reference, Orion's existing U.S. NDA [ * ] and all other applications or filings for Regulatory Approval for Orion Products for use in the breast cancer indication and related DMFs that are identified in Schedule E hereof (hereinafter "Orion Product Approvals") for the purpose of applying for and supporting Regulatory Approval of Products for use in the Field within the GTX Territory. Orion shall update Schedule E from time to time during the Term to set forth all Orion Product Approvals and DMFs that are owned and controlled by Orion. GTX recognizes that Orion has obtained the Orion Product Approvals solely for the purpose of its proprietary product Fareston(R), and that nothing herein shall be construed so as to obligate Orion to maintain or cause to be maintained any Orion Product Approvals solely for allowing GTX, its Affiliates and/or GTX Unaffiliated Sublicensees referring thereto, provided that during the Term Orion shall not withdraw such Orion Product Approvals in the absence of commercially justifiable reasons in relation to Fareston(R).
Letter of Cross-Reference. Orion agrees that the Cross Reference letter dated December 10, 1999 from Orion to GTX shall remain in effect to the extent it enables GTX or its Affiliates to reference regulatory filings for the Orion Product in all countries outside of the USA. Such Cross Reference letter may not be revoked by Orion unless this Agreement is terminated. During the Term, Orion shall permit GTX, its Affiliates and the GTX Unaffiliated Sublicensees to reference, and shall provide GTX with an appropriate authorization letter to enable GTX, its Affiliates and the GTX Unaffiliated Sublicensees to reference, all applications or filings for Regulatory Approval for Orion Products for use in the Orion Field and related DMFs that are identified in Schedule E hereof (hereinafter "Orion Product Approvals") for the purpose of applying for and supporting Regulatory Approval of Products for use in the Field within the GTX Territory. Orion shall update Schedule E from time to time during the Term to set forth all Orion Product Approvals and DMFs that are owned and controlled by Orion. GTX recognizes that Orion has obtained the Orion Product Approvals solely for the purpose of its proprietary product Fareston(R), and that nothing herein shall be construed so as to obligate Orion to maintain or cause to be maintained any Orion Product Approvals solely for allowing GTX, its Affiliates and/or GTX Unaffiliated Sublicensees to refer thereto, provided that during the Term, Orion shall not withdraw such Orion Product Approvals in the absence of commercially justifiable reasons in relation to Fareston(R). Orion shall, prior to withdrawing such Orion Product Approvals, offer to GTX the right to maintain such approvals, at GTX's expense. If GTX elects to maintain such approvals, Orion shall reasonably cooperate with GTX to enable GTX to assume such responsibility.
Letter of Cross-Reference. Orion agrees that the Cross Reference letter dated December 10, 1999 from Orion to GTX shall remain in effect and may not be revoked by Orion unless this Agreement is terminated. During the Term, Orion shall permit GTX, its Affiliates and the GTX Unaffiliated Sublicensees to reference, and shall provide GTX with an appropriate authorization letter to enable GTX, its Affiliates and the GTX Unaffiliated Sublicensees to reference, Orion’s existing U.S. NDA [ * ] and all other applications or filings for Regulatory Approval for Orion Products for use in the breast cancer indication and related DMFs that are identified in Schedule E hereof (hereinafter “Orion Product Approvals”) for the purpose of applying for and supporting Regulatory Approval of Products for use in the Field within the GTX Territory. Orion shall update Schedule E from time to time during the Term to set forth all Orion Product Approvals and DMFs that are owned and controlled by Orion. GTX [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities Act of 1933, as amended.
