Ownership of Regulatory Filings and Regulatory Approvals. Customer and its Affiliates shall, subject to the provisions of the License Agreement, be the sole owners of all Regulatory Filings and Regulatory Approvals for Recro Products. For the avoidance of doubt it is expressly agreed that Supplier shall at all times be the sole owner of all DMFs for API manufactured by or on behalf of Supplier or its Affiliates.
Ownership of Regulatory Filings and Regulatory Approvals. Subject to Section 6.1(a), Roche shall be the owner of all Regulatory Filings and Regulatory Approvals covering the Licensed Products in the Territory. Roche shall provide Prothena, through a shared file system that allows for secured access, with a copy of all Regulatory Filings and Regulatory Approvals. Roche shall list Prothena as the “collaborator” in each Regulatory Filing for Jointly Funded Product/Indications in the Shared Territory.
Ownership of Regulatory Filings and Regulatory Approvals. The Development Lead for a Product will own all right, title and interest in and to any and all Regulatory Filings and Regulatory Approvals directed to such Product and all such Regulatory Filings and Regulatory Approvals will be held in the name of the Development Lead, and the other Party will execute all documents and take all actions as are reasonably requested by the Development Lead to vest such title in the Development Lead, subject to Section 3.1.6 (Ownership of Development and Safety Data) and Section 3.2.4 (Manufacturing Matters). The Development Lead hereby grants to the other Party a non-exclusive, non-transferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in 21 C.F.R. §314.3(b)) with respect to such Regulatory Filings and Regulatory Approvals solely as necessary for the other Party, if such other Party is the Designated Regulatory Party, to prepare, submit and maintain Regulatory Filings for which it is responsible or as otherwise necessary to perform its obligations hereunder or to comply with Applicable Law.
Ownership of Regulatory Filings and Regulatory Approvals. Unless the Parties agree otherwise, Amgen or its Affiliate shall own all right, title and interest in and to any and all Regulatory Filings and Regulatory Approvals with respect to the Product in the United States and all such Regulatory Filings and Regulatory Approvals shall be held in the name of Amgen or its Affiliate, and Novartis shall execute all documents and take all actions as are reasonably requested by Amgen to vest such title in Amgen or its Affiliate, subject to Section 5.5 (Safety Matters) of the Existing License Agreement, the Safety Agreement and Section 6.3 (Responsibility for Regulatory Filings with Respect to Manufacturing; Inspections of Manufacturing Facilities).
Ownership of Regulatory Filings and Regulatory Approvals. All Regulatory Filings submitted to a Regulatory Authority, including all applications, for Regulatory Approvals for the Existing Product in the Field in the United States shall be in the name of and owned by Arcellx until transfer of the IND for the Existing Product from Arcellx to Kite in accordance with Section 4.2.4(a), and thereafter, such Regulatory Approvals and further Regulatory Filings for the Existing Product in the U.S. in the Field shall be submitted in the name of Kite and owned by Kite. All Regulatory Filings submitted to a Regulatory Authority, including all applications, for Regulatory Approvals for the Co-Promote Products in the Field in the ExUS Territory and otherwise for Non-Co-Promote Products in the Field shall be in the name of and owned by Kite.
Ownership of Regulatory Filings and Regulatory Approvals. Allergan shall be the owner of all Regulatory Filings and Regulatory Approvals covering the Co-Co Products, provided that, prior to the IND Transfer, Editas shall be the owner of the IND covering the Initial Co-Co Product in the Co-Co Territory. Allergan shall provide Editas, through a shared file system that allows for secured access, with a copy of all Regulatory Filings and Regulatory Approvals in the Co-Co Territory.
Ownership of Regulatory Filings and Regulatory Approvals. All Regulatory Filings and Regulatory Approvals relating to the Eisai Collaboration Products shall be filed by and held in the name of Eisai.
Ownership of Regulatory Filings and Regulatory Approvals. Subject to Section 4.4.1, as between the Parties, all Regulatory Filings submitted to a Regulatory Authority with respect to the Collaboration Product, including all applications for Regulatory Approvals in the Territory, shall be in the name of and owned by Taiho for Collaboration Product. To the extent a Party or its Affiliate is performing Development activities with respect to the Collaboration Product in accordance with this Agreement, the other Party shall reasonably cooperate with the performing Party, including by making Regulatory Filings and submissions in its or its Affiliates possession or control available to the performing Party, and undertaking such regulatory interactions as the Party performing (or whose Affiliate is performing) such Development activities may reasonably request or the Regulatory Authority requires for such purposes.
Ownership of Regulatory Filings and Regulatory Approvals. Consistent with the transfer of the lead regulatory role in the Territory described in Section 5.4.1 (Regulatory Communications and Filings), Amgen shall transfer to Novartis all prior Regulatory Filings in the Territory in Amgen’s possession with respect to each Licensed Product. Novartis shall not transfer title in, fail to maintain or otherwise attempt in any manner to dispose of any Regulatory Filings or Regulatory Approvals or other governmental licenses, approvals or certificates for the Licensed Products in the Territory without the prior written approval of Amgen.
Ownership of Regulatory Filings and Regulatory Approvals. Subject to Section 4.4.1, all Regulatory Filings submitted to a Regulatory Authority, including all applications, for Regulatory Approvals for the Cost Profit Sharing Products in the Field in the United States shall be in the name of and owned by Alector for Licensed Products containing AL001 (other than with respect to an Opt Out Product) and in the name of GSK for Licensed Products containing AL101 (or any Opt Out Product). Subject to Section 4.4.1, all Regulatory Filings submitted to a Regulatory Authority, including all applications, for Regulatory Approvals for the Cost Profit Sharing Products in the Field in the OUS Territory and otherwise for Opt Out Products in the Field shall be in the name of and owned by GSK. To the extent a Party or its Affiliate is performing Development activities, in each case in accordance with this Agreement, the other Party shall cooperate fully, including by making such Regulatory Filings and submissions available, and undertaking such regulatory interactions as the Party performing (or whose Affiliate is performing) such Development activities may reasonably request for such purposes. Upon (a) the determination by GSK to Initiate a Phase III Clinical Study of a Cost Profit Sharing Product for a Major Indication, (b) the date a Licensed Product becomes an Opt Out Product or (c) the date which a Party (or its successor-in-interest) is required to permanently cease Commercialization activities with respect to a Licensed Product pursuant to this Agreement (including Section 5.1.3(d)), the Parties, through the Clinical/Regulatory Working Group, shall cooperate to transfer the appropriate Regulatory Filings for such Licensed Product as soon as reasonably practicable or at a time determined by the Clinical/Regulatory Working Group.
