Ownership of Regulatory Approvals. Unless otherwise agreed in any definitive agreement executed by the Parties pursuant to Section 2.10, Licensee shall own all Regulatory Approval files and Regulatory Approvals in the Territory.
Ownership of Regulatory Approvals. Nuvios shall own all Regulatory Approval files and Regulatory Approvals in the Territory, provided that with respect to France, if Ipsen has elected to co-market the Licensed Product in France pursuant to, and in accordance with, the provisions of Section 10.2, Nuvios shall apply for two NDAs to allow co-marketing in France. One NDA shall be in the name of Nuvios and the other NDA shall be in the name of Ipsen.
Ownership of Regulatory Approvals. Unless otherwise proposed by the JSC and agreed to by the Parties, the Lead Regulatory Party shall own all INDs, BLAs and other Regulatory Approvals for a Collaboration Product in its territory for which it is responsible. The Lead Regulatory Party shall promptly license, transfer, provide a letter of reference with respect to, or take other action necessary to make available such Regulatory Approvals (including INDs and BLAs) to the other Party as may be reasonably necessary to enable such other Party to fulfill its Development and Commercialization obligations hereunder. SGI shall, in all cases, prepare, own and be responsible for the section of the applicable DMF that describes the Drug Conjugation Technology. Genmab may reference such section, but shall have no right, and SGI shall have no obligation, to provide any information contained in such DMF to Genmab and may require the applicable Regulatory Authority to maintain such information as confidential.
Ownership of Regulatory Approvals. Nisso and Replidyne shall cooperate as necessary to obtain and maintain Regulatory Approvals. Replidyne shall own and control all Regulatory Approvals and applications, amendments or supplements underlying any such Regulatory Approvals; provided that it is expressly understood and agreed that the Drug Master File for the Drug Substance shall be registered and controlled by Nisso. Nisso shall, without additional compensation, (i) collaborate with Replidyne to prepare and file the Drug Master File in “Common Technical Document” format, which shall be in form and substance satisfactory to both Nisso and Replidyne prior to filing by Nisso with the FDA, (ii) maintain such Drug Master File in good standing with all applicable Regulatory Authorities, including the payment of all required fees and the filing of all required reports (including without limitation an annual report filed with the FDA within thirty (30) days of the anniversary date of original Drug Master File submission date of each year), supplements and amendments, (iii) give a reference letter to the Regulatory Authorities in connection with Replidyne’s efforts in seeking Regulatory Approvals and submitting any such applications, amendments, or supplements for Drug Products, and (iv) only make or permit filings, submissions, changes, reports, supplements, modifications, deviations or exceptions to such Drug Master File in accordance with Section 6.1 (Drug Substance Specifications; DMF) hereof. Replidyne acknowledges and agrees that Nisso may maintain as confidential and not disclose to Replidyne the manufacturing information specified in Attachment 7.9 hereto that will be included in the Drug Master File (the “Sensitive Manufacturing Information”), provided that Replidyne shall have the right to engage a mutually agreeable third party to verify the suitability of such information for filing with the FDA in “Common Technical Document” format. Nisso shall cooperate with Replidyne in the coordination of supplements and annual reports for the Drug Master File and Regulatory Approvals, including without limitation classification of changes as “minor”, “moderate” and “major” for reporting purposes. Replidyne shall have the right, but not the obligation, to list all patents of the Supplier which are relevant to the Drug Substance in the FDA’s “Orange Book” and similar documents for other Regulatory Authorities with respect to each Drug Product. Upon the occurrence of any of the circumstances specified in ...
Ownership of Regulatory Approvals. The parties agree that Theravance shall be the sole and exclusive owner of all right, title and interest in and to all Regulatory Approvals related to the Product and any submissions for such Regulatory Approvals. Hospira shall reasonably assist Theravance in the preparation of all documents necessary to effect Theravance’s rights in such Regulatory Approval applications and submissions. Theravance shall provide to Hospira for its files a final copy of the CMC section of any such applications and/or submissions for Regulatory Approval.
Ownership of Regulatory Approvals. Following the transfer of ownership provided in Section 2.1, above, all Marketing Authorization Applications shall be filed and maintained in the name of GS and GS shall be the owner of all resulting Regulatory Approvals. Through meetings of the Steering Committee, GS shall: (i) keep LGLS informed regarding the schedule and progress for the preparation and submission of Marketing Authorization Applications in the Territory, and (ii) permit LGLS a reasonable opportunity to comment on such Marketing Authorization Applications.
Ownership of Regulatory Approvals. As between FBIO and Cephalon, FBIO (or its applicable Affiliate) shall own and maintain all Regulatory Filings made after the Effective Date for Licensed Products and all Regulatory Approvals for Licensed Products. All such filings shall be in the name of FBIO, except where otherwise required by local law. * Confidential material redacted and filed separately with the Commission.
Ownership of Regulatory Approvals. As between the Parties, Licensee will own all Regulatory Filings and Regulatory Approval for the Licensed Products for use in the Territory and in the Field filed by Licensee or any of its Affiliates or Sublicensees.
Ownership of Regulatory Approvals. Except to the extent otherwise provided elsewhere in this Agreement, Chiron shall file in its own name and own all Drug Approval Applications and Regulatory Approvals for Licensed Products in the Territory, and shall be * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION solely responsible for all communications with regulatory authorities in such countries. All such filings shall be made in such manner as may be required under the laws of the applicable jurisdiction to allow for the expeditious transfer of such Drug Approval Applications and Regulatory Approvals for Licensed Products to Cubist if such transfer is required pursuant to Article 13 hereof upon termination (but not expiration) of this Agreement. Promptly following execution of this Agreement, Cubist shall transfer and assign to Chiron any and all such Drug Approval Applications or Regulatory Approvals held by Cubist as of the date hereof.
Ownership of Regulatory Approvals. The Parties agree that Client will be the sole and exclusive owner of all right, title and interest in and to all regulatory approvals related to the API and Drug Product and any submissions for such regulatory approvals. Company will reasonably assist Client in the preparation of all documents necessary to affect Client’s rights in such regulatory approval applications and submissions, at the expense of Client.
