Ownership of Regulatory Materials. BMS will own all Regulatory Materials for Products and all such Regulatory Materials shall be submitted in the name of BMS (or its Affiliate or Sublicensee, as applicable).
Ownership of Regulatory Materials. Unless otherwise agreed by the Parties in writing, Galapagos shall solely own all Regulatory Materials and Regulatory Approvals with respect to any Pre-Program Activities or any Galapagos Product.
Ownership of Regulatory Materials. Subject to Section 7.4(b), for each Optioned Program, unless otherwise agreed by the Parties in writing, the Party conducting any Clinical Trial for any applicable Optioned Product shall solely own Regulatory Materials with respect to such Clinical Trial. Subject to the preceding sentence and Section 7.4(b), for each Optioned Program, unless otherwise agreed by the Parties in writing, each Party shall solely own all Regulatory Materials and Regulatory Approvals for any Optioned Product in its Respective Territory.
Ownership of Regulatory Materials. BeiGene will own all Regulatory Materials for Compounds and Products and all such Regulatory Materials shall be submitted in the name of BeiGene (or its Affiliate or Sublicensee, as applicable) with the exception of the CMC sections of Regulatory Materials containing Confidential CMC Information or any DMF owned by Ambrx in accordance with this Section 4.6.
Ownership of Regulatory Materials. Any and all Regulatory Materials, including Regulatory Approvals, arising under this Agreement in respect of the Lead DMD Product and the Manufacture thereof, including labeling and packaging and any Drug Master Files and Chemistry, Manufacturing and Control (“Chemistry Manufacturing and Control” or “CMC”) (or equivalent) sections of any such Regulatory Materials shall be in the name of Sarepta or its Affiliate(s), and Sarepta or its Affiliate(s) shall own all right, title and interest in and to all such Regulatory Materials; provided, however, that Regulatory Materials, including Regulatory Approvals, solely relating to establishment license approvals for the Manufacture of Bulk Drug Substance and/or Drug Product shall be in the name of Catalent, and Catalent shall own all right, title and interest in and to only such Regulatory Materials, subject to and after giving effect to Sarepta’s right to use such establishment license approvals in connection with its Development, Manufacturing and Commercialization activities for the Manufacture of Bulk Drug Substance and/or Drug Product.
Ownership of Regulatory Materials. Subject to Article 17, all BMS Regulatory Data, and Regulatory Approvals and related Regulatory Documentation for Licensed Compound or Licensed Product, shall be the sole property of BMS (subject to the license grant by BMS to ATI set forth in Section 8.4(a)) and held in the name of BMS (or in each such case its Affiliate or Sublicensee), even if ATI is primarily responsible for them hereunder.
Ownership of Regulatory Materials. XXXx, NDAs and Marketing Approvals. Unless otherwise required under applicable Law or otherwise determined by the JRDC, ownership of the right, title and interest in and to any and all Regulatory Materials, XXXx, NDAs and Marketing Approvals directed to a Licensed Product in a country shall be held in the name of Pfizer for the Pfizer Territory and in the name of Servier for the Servier Territory, and the other Party shall execute all documents and take all actions as are reasonably requested by such Party to vest such title in such Party, subject to Section 12.1.
Ownership of Regulatory Materials. As between the Parties, any and all Regulatory Materials, including Regulatory Approvals, arising under this Agreement in respect of the Passage Bio Products and the Manufacture thereof, including labeling and packaging and any Drug Master Files and Chemistry, Manufacturing and Control (“CMC”) (or equivalent) sections of any such Regulatory Materials shall be in the name of Passage Bio, and Passage Bio shall own all right, title and interest in and to all such Regulatory Materials; provided, however, that Regulatory Materials, including Regulatory Approvals, solely relating to establishment license approvals for the Manufacture of Bulk Drug Substance and/or Drug Product shall be in the name of Catalent, and Catalent shall own all right, title and interest in and to only such Regulatory Materials, subject to and after giving effect to Passage Bio’s right to use such establishment license approvals in connection with its Development, Manufacturing and Commercialization activities for the Manufacture of Bulk Drug Substance and/or Drug Product.
Ownership of Regulatory Materials. Any and all Regulatory Materials, including Regulatory Approvals, arising under the Dedicated Clean Room Collaboration in respect to BridgeBio Products and the Manufacture thereof, including labeling and packaging and any Drug Master Files and Chemistry, Manufacturing and Control (“CMC”) (or equivalent) sections of any such Regulatory Materials shall be in the name of the applicable BridgeBio Entity, and such BridgeBio Entity shall own all right, title and interest in and to all such Regulatory Materials; provided, however, that Regulatory Materials, including Regulatory Approvals, solely relating to establishment license approvals for the BWI Facility and the Dedicated Clean Room Suite shall be in the name of Catalent, and Catalent shall own all right, title and interest in and to only such Regulatory Materials, subject to and after giving effect to the BridgeBio Entity’s right to use such establishment license approvals in connection with its Development, Manufacturing and Commercialization activities for the Manufacture of BridgeBio Product.
Ownership of Regulatory Materials. Exactus BioSolutions will own all Regulatory Materials for Products and all such Regulatory Materials shall be submitted in the name of Exactus BioSolutions (or its Affiliate as applicable).
