Common use of Ownership of Regulatory Filings Clause in Contracts

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. Novartis Gilead will own all INDs, NDAsapplications for Regulatory Approval and related regulatory documentation in the Territory with respect to any Licensed Product or Gilead Combination Product. As soon as reasonably practicable but not later than […***…] months after the Effective Date, Galapagos will assign and transfer to Gilead all INDs, applications for Regulatory Materials and Approval, 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 Territory, as well as any safety and clinical databases, with respect to such Global Licensed Product and any Regulatory Approvals and related documentation, in each case, that is in the possession or control Control of Surface, including any drug master files maintained by or on behalf of Surface solely with respect thereto, and each Galapagos. Each Party will submit all filings, letters and other documentation necessary to effect such assignment assignments and transfer transfers to the applicable Regulatory Authority as soon as reasonably practicable, but no later than [***] after such request for such Global Licensed ProductAuthority. 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 Until the date that the transfer of all INDs, Regulatory Materials INDs and related regulatory documents filed with or submitted to any Regulatory Authority in the Novartis Territory that relate related to such Global Licensed Product becomes effective (the “Regulatory Transition Date”), Galapagos shall, under the direction of Gilead, handle all matters related to each Licensed Product involving Regulatory Authorities, to the extent not yet assigned and transferred to Gilead, and shall keep Gilead fully informed of all regulatory matters relating to any Licensed Product in the Territory, including providing Gilead with reasonable advance notice of all formal meetings and teleconferences with Regulatory Authorities in the Territory pertaining to any Licensed Product. Galapagos shall permit Gilead to have, including any drug master files maintained by or on behalf at Gilead’s expense, representatives of Surface solely Gilead to lead such formal meetings and teleconferences with respect thereto, becomes effective, and Novartis hereby accepts Regulatory Authorities in the Territory pertaining to such appointmentLicensed Product.

Ownership of Regulatory Filings. Novartis Esperion will own all INDs, NDAs, Regulatory Materials Approvals and related regulatory documentation Regulatory Documentation submitted to any Regulatory Authority with respect to any Global Licensed ProductProduct in the DSE Territory; provided, including any drug master files maintained by or on behalf of Surface solely with respect thereto. At Novartis’s request following that within [***] days after receipt of the Regulatory Approvals for the Licensed Product in the DSE Territory (as determined on a Global regulatory jurisdiction-by-regulatory jurisdiction basis), Esperion shall assign such Regulatory Approvals for such regulatory jurisdictions to DSE or its designated Affiliates, and DSE or its designated Affiliates shall retain ownership of each such Regulatory Approvals. Together with such assignment of such Regulatory Approvals, Esperion shall provide DSE with full registration dossiers of Licensed ProductProduct in the DSE Territory in eCTD format as well as complete electronic copies of all other necessary Regulatory Documentation available to Esperion, Surface will promptly assign and transfer to Novartis all INDssuch as, but not limited to, Regulatory Materials Approval application assessment reports and other regulatory documentation all Material Communication. After such assignment to DSE, DSE or its designated Affiliates will: (i) maintain the Regulatory Approvals, including by complying with all obligations of the Marketing Authorisation Holder in the Novartis Territory accordance with Directive 2001/83/EC with respect to such Global the Regulatory Approvals, (ii) enable and authorize Esperion to make additional submissions to Regulatory Authorities (including to amend labelling for 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 Products as soon as reasonably practicable, but no later than described [***] 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 INDICATES MATERIAL THAT HAS BEEN OMITTED AND REPLACED WITH “[***]”FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. A COMPLETE VERSION OF THIS EXHIBIT ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. Product involving Regulatory Authorities AMENDED herein) and (iii) obtain such other approvals as may be required for Esperion to perform its Development obligations hereunder 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 appointmenta timely manner.

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. Novartis 3.1.1.1. Genzyme will own all INDs, NDAs, Regulatory Materials NDAs and related regulatory documentation submitted to any Regulatory Authority in the Genzyme Territory with respect to any Global Co-Co Licensed Product. At Genzyme’s request following the Implementation Date for a Co-Co 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 Alnylam will promptly assign and transfer to Novartis Genzyme all INDs, Regulatory Materials NDAs and other regulatory documentation submitted to any Regulatory Authority in the Novartis Genzyme Territory with respect to such Global Co-Co 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 theretoAlnylam, 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 [***] days after such request for such Global Co-Co Licensed Product. For clarity, Surface will not be required to transfer in each case, excluding any drug master files maintained by or on behalf of any Third PartyAlnylam, 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, which shall be and Commercialization of Global Licensed Productsremain Alnylam’s sole responsibility. Surface Alnylam hereby appoints Novartis Genzyme as SurfaceAlnylam’s agent for all matters related to each Global Co-Co Licensed Product involving Regulatory Authorities in the Genzyme Territory during the period beginning on the Implementation Date for such Co-Co 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 UNDER RULE 406 PROMULGATED UNDER 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED1934. Product involving Regulatory Authorities in the Novartis Territory during the period beginning on the Option Exercise Date for such Global Licensed CO-CO LICENSE TERMS Product and ending on the date that the transfer of all INDs, Regulatory Materials NDAs and related regulatory documents filed with or submitted to any Regulatory Authority in the Novartis Genzyme Territory that relate to such Global Co-Co Licensed ProductProduct becomes effective, including and Genzyme hereby accepts such appointment, excluding any drug master files maintained by or on behalf of Surface solely with respect theretoAlnylam, becomes effective, which shall be and Novartis hereby accepts such appointmentremain Alnylam’s sole responsibility.