Applications for Regulatory Exclusivity. The Parties recognize that exclusivity rights granted or provided for under regulatory laws of any country may be commercially significant to Assigned Products. To the extent permitted by law, as between the Parties, Pharmacyclics has the exclusive right to file for, request and maintain any regulatory exclusivity rights for any and all Assigned Products, including without limitation, regulatory exclusivity rights based upon an orphan drug designation of an Assigned Product, and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights.
Applications for Regulatory Exclusivity. The Parties recognize that exclusivity rights granted or provided for under regulatory laws of the countries of the Territory may be commercially significant to Collaboration Products. To the extent permitted by law, as between the Parties, Amgen shall have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Collaboration Products in the Territory (including without limitation regulatory exclusivity rights based upon an orphan drug designation of a Collaboration Product) and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights.
Applications for Regulatory Exclusivity. The Parties recognise that exclusivity rights granted or provided for under regulatory laws of the countries of the Territory may be commercially significant to Antibody Products. To the extent permitted by law, as between the Parties, the Territorial Commercial Lead for a country shall have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Antibody Products in such country (including regulatory exclusivity rights based upon an orphan drug designation of an Antibody Product) and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights.
Applications for Regulatory Exclusivity. The Parties recognize that exclusivity rights granted or provided for under regulatory laws of the countries of the Territory may be commercially significant to Licensed Products. To the extent permitted by law, InterMune shall have the exclusive right (even as to Amgen) to file for, request and maintain any regulatory exclusivity rights for Licensed Products in the Territory, including without limitation regulatory exclusivity rights based upon an orphan drug designation of a Licensed Product, and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights, and Amgen shall reasonably cooperate with InterMune in such actions at InterMune's expense.
Applications for Regulatory Exclusivity. The Parties recognize the commercial value of exclusivity rights to Product granted or provided for under laws and regulations in the Territory. To the extent permitted by law, KDP will have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Product in the Territory (including regulatory exclusivity rights based upon an orphan drug designation of Product) and to conduct and prosecute any proceedings or actions to enforce the regulatory exclusivity rights.
Applications for Regulatory Exclusivity. The Parties recognize the commercial value of exclusivity rights to Licensed Product granted or provided for under regulatory laws of the countries in the Bayer Territory. To the extent permitted by law, Bayer will have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Licensed Product in the Bayer Territory (including without limitation regulatory exclusivity rights based upon an orphan drug designation of Licensed Product) and to conduct and prosecute any proceedings or actions to enforce the regulatory exclusivity rights.
Applications for Regulatory Exclusivity. The Parties recognize that exclusivity rights granted or provided for under regulatory laws of the countries in the Gilead Territory are likely to be [ ]* to Licensed Products. To the extent permitted by law, Gilead shall have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Licensed Products in the Gilead Territory, including without limitation regulatory exclusivity rights based upon an orphan drug designation of a Licensed Product, and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights, and Cubist shall reasonably cooperate with Gilead in such actions [ ]*. In countries where Gilead is not entitled to take one or more of the actions described in the foregoing sentence, then Cubist shall take such actions as instructed by Gilead and for the benefit of Gilead, [ ]*. Gilead shall own any regulatory exclusivity rights in the Gilead Territory where permitted by law. Cubist hereby grants Gilead the exclusive right to market Licensed Products in the Gilead Territory under any regulatory exclusivity rights that must be granted directly to Cubist in a given country in the Gilead Territory.
Applications for Regulatory Exclusivity. The Parties recognize the commercial value of exclusivity rights to Product granted or provided for under laws and regulations in the Territory. To the extent permitted by law, SKK will have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Product in the Territory (including regulatory exclusivity rights based upon an orphan drug designation of Product) and to conduct and prosecute any proceedings or actions to enforce the regulatory exclusivity rights.
Applications for Regulatory Exclusivity. The Parties recognize that exclusivity rights granted or provided for under regulatory laws of the countries of the Territory may be commercially significant to Collaboration Products. To the extent permitted by law, as between the Parties, the Commercial Lead shall have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Collaboration Products in the Territory (including without limitation regulatory exclusivity rights based upon an orphan drug designation of a Collaboration Product) and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights. [***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Applications for Regulatory Exclusivity. The Parties recognize that exclusivity rights that may be granted or provided for under regulatory laws of the countries in the GSK Territory are likely to [ * ] of Licensed Products in such Territory. To the extent permitted by law, GSK shall have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Licensed Products for Licensed Indications in the GSK Territory, including without limitation regulatory exclusivity rights based upon an orphan drug designation of a Licensed Product in a country in the GSK Territory, and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights; provided, however, that except as provided in Section 3.6 or 3.8(c), GSK shall not develop or seek Regulatory Approval for any Licensed Product for an Other Indication. Gilead shall use its reasonable efforts to cooperate with GSK in such actions relating to regulatory exclusivity [ * ] In countries where GSK is not permitted by law to take one or more of the actions described above with respect to regulatory exclusivity but Gilead is so permitted, Gilead shall use its reasonable efforts to support GSK in such actions, [ * ] GSK shall own any regulatory exclusivity rights for the Licensed Product in the GSK Territory where permitted by law. Gilead hereby grants GSK the exclusive right to market Licensed Products for Licensed Indications in the GSK Territory under any regulatory exclusivity rights that, according to legal requirements in a country in the GSK Territory, must be granted directly to Gilead in such country. Without limitation, this Section 4.7 shall apply to Class I Certifications and Class II Certifications relating to Licensed Products and Licensed Indications, and applications therefor. The foregoing in this Section 4.7 shall not apply to Administrative Protections and applications therefor, which are separately treated in Section 10.2(e). To the extent that any of the foregoing forms of regulatory exclusivity would exclude Gilead (and its Affiliates and licensees) from developing or Commercializing, in a manner that is otherwise permitted hereunder, an Other Formulation or a Licensed Product to treat an Other Indication, then, subject to GSK's rights under Section 3.5(e), GSK hereby grants Gilead (and its Affiliates and licensees) the right under such form of regulatory exclusivity to conduct such development and Commercialization, and covenants that GSK (and its Affiliates and Permitted Su...
