Ownership of Regulatory Documentation. Unless and until Isis sends an Election Notice pursuant to Article 9 of this Agreement, all Regulatory Documentation with respect to a Product will be owned by OncoGenex, or its sublicensee, if applicable. If OncoGenex discontinues development of such Product and Isis sends an Election Notice in accordance with Section 9.2, all Regulatory Documentation with respect to such Product will be transferred to Isis. In the event that this Agreement terminates pursuant to Section 9.2, all Regulatory Documentation will remain with the Party that first secured such Regulatory Documentation.
Ownership of Regulatory Documentation. As between the Parties, each Company Licensee shall own, and, subject to this Article 3, shall have the exclusive right to prepare, submit, and maintain, all Regulatory Documentation that it submits to or receives from the Regulatory Authorities following the Effective Date with respect to the Licensed Products in the Company Field in the Territory (to the extent, with respect to each Company Licensee, such Company Licensee has rights hereunder with respect thereto). For clarity, as between the Parties, the Pfizer Licensors shall own all other Regulatory Documentation.
Ownership of Regulatory Documentation. All Regulatory Documentation with respect to the Product will be owned by OncoGenex.
Ownership of Regulatory Documentation. Fovea shall exclusively own all Regulatory Documentation relating to Licensed Combinations.
Ownership of Regulatory Documentation. All Regulatory Approvals with respect to the Product will be owned by OncoGenex for the duration of the Collaboration. If the Collaboration terminates, or if one Party discontinues performance according to the terms of this Agreement, all Regulatory Approvals will remain with the Party that has retained the rights to the Product.
Ownership of Regulatory Documentation. Subject to the license grants in Article 3, all Regulatory Approvals with respect to a Collaboration Product shall be owned by [*], with [*] on a [*] with respect to [*]. With respect to [*] and any other Collaboration Products with respect to the same Collaboration Target, the Regulatory Approvals shall [*]. Subject to the license grants in Article 3, [*], to the extent permitted by law, [*] other Regulatory Documentation, provided that Regulatory Documentation containing or comprising Production Know-How of a Party shall be and remain the sole and exclusive property of such Party. With respect to [*] to [*], and any other Collaboration Products with respect to the same Collaboration Target, [*] shall be [*]. Each non-Opting-Out Party shall have the right to own all right, title and interest in and to all Regulatory Approvals with respect to its Unilateral Products. In the event that a Party Opts-Out with respect to a Collaboration Product, it shall assign all of its right, title and interest in and to all Regulatory Documentation with respect to such Collaboration Product, including any Regulatory Approvals and applications therefor, to the non-Opting Out Party (or its designee); provided, however, that each Party shall retain any of its right, title and interest in and to any Regulatory Documentation with respect to a Dormant Product. Notwithstanding the ownership of any Regulatory Approval or any other Regulatory Documentation, each Party shall have the right to use and reference any of the Regulatory Documentation in connection with the Exploitation of Collaboration Products as provided in this Agreement.
Ownership of Regulatory Documentation. Subject to the terms of this Agreement, including Sections 3.06 and 13.06, and without affecting ownership or title to any BDSI Know-How or BDSI Documentation contained or referenced therein, Purdue shall, following the Marketing Authorization Transfer, own all Marketing Authorizations, Governmental Approvals and all other Regulatory Filings related thereto in the Territory with respect to Licensed Product, except those filings that may be made by or on behalf of BDSI, any Affiliate thereof, or any Third Party in relation to the exercise of BDSI’s retained rights with respect to Licensed Products in the Territory or performance of BDSI’s obligations under this Agreement or the Supply Agreement.
Ownership of Regulatory Documentation. 5.1.1. All Regulatory Documentation (including NDAs and Product Labeling and Inserts) relating to the Existing Products and Impax Generic Versions (whether for the Approved Indications or any New Indication) other than INDs filed by Impax or its Affiliates for Impax Studies relating to Existing Products, shall be retained and owned by, and shall be the sole property and held in the name of, AstraZeneca or its designated Affiliate (the “AstraZeneca Regulatory Documentation”).
5.1.2. All Regulatory Documentation (including NDAs and Product Labeling and Inserts) relating to Additional Products, and all INDs filed by Impax or its Affiliates for Impax Studies relating to Existing Products, shall be retained and owned by, and shall be the sole property and held in the name of, Impax or its designated Affiliate (or the applicable Third Party in the case of an ISS) (the “Impax Regulatory Documentation”). For clarity, notwithstanding the ownership thereof by Impax or its designated Affiliate (or the applicable Third Party, the case of an ISS), the content of all Material Impax Regulatory Documentation shall be subject to approval by AstraZeneca pursuant to Section 5.2.2.
Ownership of Regulatory Documentation. LICENSEE will own all INDs, Orphan Drug Designations, BLAs and related documentation submitted to any Regulatory Authority and all Regulatory Approvals with respect to the Products.
Ownership of Regulatory Documentation. Novartis shall own and retain all right, title and interest in and to all Regulatory Documentation (including regulatory approvals) with respect to Novartis Licensed Products in the Primary Field and Secondary Field in the Territory. Fluidigm shall promptly disclose to Novartis in writing, and shall cause its Affiliates to so disclose, any such Regulatory Documentation and the development of any such Regulatory Documentation, and shall, and does hereby, assign, and shall cause its Affiliates to so assign, to Novartis, without additional compensation, such right, title and interest in and to any such Regulatory Documentation as of the Effective Date and from time to time during the term of this Agreement, as is necessary to fully vest sole ownership in Novartis as provided for in the foregoing sentence.
