Ownership of Regulatory Filings. (a) Subject to Section 7.1(b) and Section 7.2(b), during the Merck Participation Term for a given Program, all applications for Regulatory Approval, the Regulatory Approvals, and other Regulatory Filings (other than DMFs) (including all INDs and CTAs) relating to the applicable Collaboration Products will be the property of [***] and held in the name of [***] or its designees. [***] shall provide the JDC with regular updates regarding the status of Regulatory Filings and correspondences for Collaboration Products, and such Regulatory Filings and correspondences shall be reviewed by the JDC or a working group established by such committee.
(b) With respect to the Collaboration Products, if not previously prepared and filed, Moderna will, at Merck’s request, prepare, file and maintain with all applicable Regulatory Authorities a DMF for the Collaboration Products and, subject to the remainder of this Section 7.2(b), Moderna shall also provide such other information and assistance as Merck may reasonably request in connection with the completion of and submission of applications for Regulatory Approvals for Collaboration Products and the maintenance thereof. Merck and its Affiliates and Sublicensees may refer to such DMF in any filing made in connection with obtaining or maintaining a Regulatory Approval for a Collaboration Product and [***] hereby grants such a Right of Reference. [***] will be responsible for assuring that during the Term, such [***] will be in the form appropriate for filing with all applicable Regulatory Authorities, including those in [***], and [***] shall be maintained in full force and effect by [***] during the Term and will not be amended without the consent of [***], other than with respect to amendments that [***] will, on written request by [***], provide to the requesting party and to any specified Regulatory Authority [***]. If [***] has not filed [***], then any and all [***] required to be included in any Regulatory Filing [***] shall be provided by [***] to the appropriate individuals [***]. To the extent that [***], then [***] will first notify and discuss with the appropriate representatives at [***]; provided that such [***] employees [***].
(c) With respect to any Independent Additional Study, upon the IAS Party’s completion of an Independent Additional Study for a given Program, the IAS Party will provide the data and related information and documents with respect thereto to the non-IAS Party, and the Parties will meet ...
Ownership of Regulatory Filings. Novartis will own all INDs, NDAs, Regulatory Materials and related regulatory documentation with respect to any T1 Licensed Product, including any drug master files maintained by or on behalf of Surface solely with respect thereto (provided however that Surface will not be obligated to transfer any drug master files maintained by or on behalf of any Third Party, including any contract manufacturer). At Novartis’s request following [***] for the T1 Research Program, Surface will promptly assign and transfer to Novartis all INDs, Regulatory Materials and other regulatory documentation in the Novartis Territory with respect to such T1 Licensed Product that is in the possession or control of Surface, including any drug master files maintained by or on behalf of Surface solely with respect thereto, and each Party will submit all filings, letters and other documentation necessary to effect such assignment and transfer to the applicable Regulatory Authority as soon as reasonably practicable, but no later than [***] after such request for such T1 Licensed Product. For clarity, Surface will not be required to transfer any drug master files maintained by or on behalf of any Third Party, including any contract manufacturer; provided that Novartis has access to or rights to cross-reference those drug master files pursuant to Section 7.1.3 to permit Novartis to comply with its regulatory obligation in connection with the Research, Development, Manufacture, and Commercialization of T1 Licensed Products. Surface hereby appoints Novartis as Surface’s agent for all matters related to each T1 Licensed Product involving Regulatory Authorities in the Novartis Territory during the period beginning on the Effective Date for the T1 Licensed Product and ending on the date that the transfer of all INDs, Regulatory Materials and related regulatory documents in the Novartis Territory that relate to such T1 Licensed Product, including any drug master files maintained by or on behalf of Surface solely with respect thereto, becomes effective, and Novartis hereby accepts such appointment.
Ownership of Regulatory Filings. Novartis will own all INDs, NDAs, Regulatory Materials and related regulatory documentation submitted to any Regulatory Authority with respect to any Global Licensed Product, including any drug master files maintained by or on behalf of Surface solely with respect thereto. At Novartis’s request following [***] for a Global Licensed Product, Surface will promptly assign and transfer to Novartis all INDs, Regulatory Materials and other regulatory documentation in the Novartis Territory with respect to such Global Licensed Product that is in the possession or control of Surface, including any drug master files maintained by or on behalf of Surface solely with respect thereto, and each Party will submit all filings, letters and other documentation necessary to effect such assignment and transfer to the applicable Regulatory Authority as soon as reasonably practicable, but no later than [***] after such request for such Global Licensed Product. For clarity, Surface will not be required to transfer any drug master files maintained by or on behalf of any Third Party, including any contract manufacturer; provided that Novartis has access to or rights to cross-reference those drug master files pursuant to Section 7.3.3 to permit Novartis to comply with its regulatory obligation in connection with the Research, Development, Manufacture, and Commercialization of Global Licensed Products. Surface hereby appoints Novartis as Surface’s agent for all matters related to each Global Licensed CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Product involving Regulatory Authorities in the Novartis Territory during the period beginning on the Option Exercise Date for such Global Licensed Product and ending on the date that the transfer of all INDs, Regulatory Materials and related regulatory documents in the Novartis Territory that relate to such Global Licensed Product, including any drug master files maintained by or on behalf of Surface solely with respect thereto, becomes effective, and Novartis hereby accepts such appointment.
Ownership of Regulatory Filings. Voyager will own all INDs and related documentation submitted to any Regulatory Authority with respect to any Collaboration Product.
Ownership of Regulatory Filings. 6.2.1.1. Voyager Territory. Voyager will own all INDs, BLAs and related regulatory documentation submitted to any Regulatory Authority in the Voyager Territory with respect to any Split Territory Licensed Product.
6.2.1.2. Genzyme Territory. Genzyme will own all INDs, BLAs and related regulatory documentation submitted to any Regulatory Authority in the Genzyme Territory with respect to any Licensed Product as well as any drug master files maintained by or on behalf of Genzyme anywhere in the world with respect to any Licensed Product. Promptly following the Option Exercise Date for a Licensed Product, Voyager will assign and transfer to Genzyme all INDs and related regulatory documentation submitted to any Regulatory Authority in the Genzyme Territory with respect to such Licensed Product that is in the possession or control of Voyager. Each Party will submit all filings, letters and other documentation necessary to effect such assignments and transfers to the applicable Regulatory Authority no later than [***] after such request for such Licensed Product. Voyager hereby appoints Genzyme as Voyager’s agent for all matters related to each Licensed Product involving Regulatory Authorities in the Genzyme Territory and ending on the date that the transfer of all INDs and related regulatory documents filed with or submitted to any Regulatory Authority in the Genzyme Territory that related to such Licensed Product becomes effective, and Genzyme hereby accepts such appointment.
Ownership of Regulatory Filings. Client shall be the sole owner of all Regulatory Filings and all governmental approvals obtained by Client from any Regulatory Authority with respect to the Drug Substance or the Product.
Ownership of Regulatory Filings. CLIENT shall be the sole owner of all regulatory filings and all governmental approvals obtained by CLIENT from any Regulatory Authority with respect to the Product. Notwithstanding the foregoing, and for the avoidance of doubt, all rights in and to XXXX Intellectual Property Rights and XXXX Confidential Information shall remain entirely vested in XXXX.
Ownership of Regulatory Filings. Except for the Filed IND, all INDs, NDAs and other regulatory filings made or filed by GPC with respect to any Covered Products shall be in the name of, and be owned solely by, GPC.
Ownership of Regulatory Filings. PROTEON shall be the sole owner of all Regulatory Filings and all governmental approvals obtained by PROTEON from any Regulatory Authority with respect to the Drug Substance or the Product.
Ownership of Regulatory Filings. Helix shall prepare, maintain, share with CPL as appropriate, and be the sole owner of all applicable or relevant Regulatory Filings and all governmental approvals granted by any Regulatory Authority with respect to the Product, including all copyright and CPL waives all moral rights therein.
