VIVUS Retained Rights. Notwithstanding the transfer of the Product Marketing Authorization by VIVUS to Auxilium as provided in Section 5.1, VIVUS shall, in all circumstances, retain the following rights after such transfer: (i) VIVUS shall exercise control over the selection of the manufacturer of the Product for sale in the Auxilium Territory unless and until the Supply Chain Transfer occurs pursuant to Section 6.2; and (ii) VIVUS shall remain the owner of all data filed with Regulatory Authorities in connection with the Product Marketing Authorization and the Label Expansion Filing and shall retain the right, with prior written notice to Auxilium, to grant access to this data to Third Parties who are collaborating with or otherwise assisting VIVUS in connection with the Development or Commercialization of the Product for use in the Field outside the Auxilium Territory, or manufacturing of the Product and/or the development, commercialization, or manufacturing of any other VIVUS product; and (iii) VIVUS shall, in accordance with Section 5.2(c), retain final decision-making right with respect to the content of any communications with Regulatory Authorities in the Auxilium Territory in connection with the qualification of Product manufacturers unless and until a Supply Chain Transfer occurs pursuant to Section 6.2.
Appears in 2 contracts
Samples: License and Commercialization Agreement (Auxilium Pharmaceuticals Inc), License and Commercialization Agreement (Vivus Inc)
VIVUS Retained Rights. Notwithstanding the transfer of the Product Marketing Authorization by VIVUS to Auxilium Licensee as provided in Section 5.1, VIVUS shall, in all circumstances, retain the following rights after such transfer: (i) VIVUS shall exercise control over the selection of the manufacturer of the Product for sale in the Auxilium Licensee Territory unless and until the Supply Chain Transfer occurs pursuant to Section 6.2; and (ii) VIVUS shall remain the owner of all data filed with Regulatory Authorities in connection with the Product Marketing Authorization and the Label Expansion Filing and shall retain the right, with prior written notice to AuxiliumLicensee, to grant access to this data to Third Parties who are collaborating with or otherwise assisting VIVUS in connection with the Development or Commercialization of the Product for use in the Field outside the Auxilium Licensee Territory, or manufacturing of the Product and/or the development, commercialization, or manufacturing of any other VIVUS product; and (iii) VIVUS shall, in accordance with Section 5.2(c), retain final decision-making right with respect to the content of any communications with Regulatory Authorities in the Auxilium Licensee Territory in connection with the qualification of Product manufacturers unless and until a Supply Chain Transfer occurs pursuant to Section 6.2.
Appears in 1 contract
Samples: License and Commercialization Agreement (Petros Pharmaceuticals, Inc.)
VIVUS Retained Rights. Notwithstanding the transfer of the Product Marketing Authorization for the Product by VIVUS to Auxilium Menarini as provided in Section 5.14.2 above, VIVUS shall, in all circumstances, retain the following rights after such transfer: (i) VIVUS shall shall, in accordance with Section 2.2(a) of this Agreement, exercise control over the selection of the manufacturer of the Product for sale in the Auxilium Menarini Territory unless and until the Supply Chain Transfer occurs supply chain for the Menarini Territory is transferred to Menarini pursuant to Section 6.2; and (ii) VIVUS shall remain the owner of all data filed with Regulatory Authorities in connection with the Product Marketing Authorization Existing MAA and the Label Expansion Filing and shall retain the right, with prior written notice to AuxiliumMenarini, to grant access to this data to Third Parties who are collaborating with or otherwise assisting VIVUS in connection with the Development or Commercialization of the Product for use in the Field outside the Auxilium TerritoryDevelopment, Commercialization, or manufacturing of the Product and/or the development, commercialization, or manufacturing of any other VIVUS product; and (iii) VIVUS shall, in accordance with Section 5.2(c5.1(d), retain final decision-making right with respect to the content of any communications with Regulatory Authorities in the Auxilium Menarini Territory in connection with (A) any Post-Marketing Requirements or any post-Regulatory Approval studies in relation to the Product and (B) qualification of Product manufacturers unless and until a Supply Chain Transfer occurs pursuant to Section 6.2manufacturers.
Appears in 1 contract
Samples: License and Commercialization Agreement (Vivus Inc)
VIVUS Retained Rights. Notwithstanding the transfer of the Product Marketing Authorization by VIVUS to Auxilium Licensee as provided in Section 5.15.1, VIVUS shall, in all circumstances, retain the following rights after such transfer: (i) VIVUS shall exercise control over the selection of the manufacturer of the Product for sale in the Auxilium Licensee Territory unless and until the Supply Chain Transfer occurs pursuant to Section 6.26.2; and (ii) VIVUS shall remain the owner of all data filed with Regulatory Authorities in connection with the Product Marketing Authorization and the Label Expansion Filing and shall retain the right, with prior written notice to AuxiliumLicensee, to grant access to this data to Third Parties who are collaborating with or otherwise assisting VIVUS in connection with the Development or Commercialization of the Product for use in the Field outside the Auxilium Licensee Territory, or manufacturing of the Product and/or the development, commercialization, or manufacturing of any other VIVUS product; and (iii) VIVUS shall, in accordance with Section 5.2(c5.2(c), retain final decision-making right with respect to the content of any communications with Regulatory Authorities in the Auxilium Licensee Territory in connection with the qualification of Product manufacturers unless and until a Supply Chain Transfer occurs pursuant to Section 6.26.2.
Appears in 1 contract
Samples: License and Commercialization Agreement (Vivus Inc)