Akcea: Special Consequences of Certain Terminations. If (A) Novartis terminates the Agreement under Section 11.2.1 or Section 11.2.7 or (B) Akcea terminates this Agreement under Section 11.2.2(b), Section 11.2.3(b), Section 11.2.5, Section 11.2.6, or Section 11.2.7, then, in addition to the terms set forth in Section 11.3.1, the following additional terms will also apply but only with respect to the Terminated Product: (a) Novartis will and hereby does grant to Akcea: (i) a sublicensable, worldwide, exclusive license or sublicense, as the case may be, under all Novartis Technology (excluding Novartis Background Technology) Controlled by Novartis as of the date of such termination that Covers the Terminated Product as of such date; (ii) a sublicensable, worldwide, non-exclusive royalty-bearing license or sublicense, as the case may be, under all Novartis Background Technology Controlled by Novartis as of the date of such termination that Covers the Terminated Product as of such date; provided, however, that Akcea will not sublicense to [***] any Novartis Background Know-How claiming or covering [***] without Novartis’ prior written consent (such consent not to be unreasonably withheld, delayed or conditioned); and (iii) in each case solely to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Terminated Product. Novartis will execute confirmatory license grants of the licenses granted to Akcea under this Section 11.3.2(a) within [***] ([***]) calendar days following the effective date of termination. If, after the effective date of such termination, Akcea or any of its Affiliates or Sublicensees Commercializes a Terminated Product previously licensed to Novartis under Section 5.1.1 or Section 5.1.2 (as applicable), then Akcea will pay Novartis a mutually * ***Confidential Treatment Requested agreed royalty on terms to be negotiated in good faith. (b) Within [***] ([***]) calendar days following the date of termination, Novartis will deliver to Akcea for use with respect to the Development and Commercialization of the Terminated Product, any Know-How, data, results, regulatory information, pricing and market access strategy information, health economic study information, material communications with payors, regulatory filings in the possession of Novartis, or copies thereof, as of the date of such termination that relate solely to such Terminated Product; (c) Within [***] ([***]) calendar days following the date of termination, Novartis will grant to Akcea an exclusive, royalty-free, fully paid up license under any Trademarks that are specific to a Terminated Product solely for use with such Terminated Product; (d) Akcea will control and be responsible for all aspects of the Prosecution and Maintenance of all Akcea Product-Specific Patents and Jointly-Owned Program Patents and Novartis will provide Akcea with (and will instruct its counsel to provide Akcea with) all of the information and records in Novartis’ and its counsel’s possession related to the Prosecution and Maintenance of such Akcea Product-Specific Patents and Jointly-Owned Program Patents, in each case only in respect of the Terminated Product; (e) If requested by Akcea, Novartis will sell to Akcea all remaining API or Finished Drug Product in Novartis’ possession at a price equal to [***] (or [***]) at the time such material was [***]; and (f) Akcea may request Novartis to support (or cause to be supported by Novartis’ CMO) a technology transfer to Akcea (or Akcea’s designated Third Party supplier) of any technology, information and data reasonably related to Novartis’ or such CMO’s manufacturing and supply of API and/or Finished Drug Product for such Product, and if so requested, Novartis will, at no cost to Akcea for the first [***] hours of Novartis’ time, support (or cause to be supported by Novartis’ CMO) such a technology transfer and Novartis will (or will cause Novartis’ CMO to) continue to (i) provide reasonable support and cooperation with Akcea’s regulatory filings and interactions with Regulatory Authorities related to Novartis’ or such CMO’s API and/or Finished Drug Product manufacturing (including any required inspections), and (ii) supply (or cause to be supplied by Novartis’ CMO) API and/or Finished Drug Product to Akcea, at a price equal to [***] ([***]) at the time such material was [***], for a * ***Confidential Treatment Requested period of up to [***] ([***]) months to enable Akcea to identify and contract with a suitable Third Party API and/or Finished Drug Product manufacturer.
Appears in 3 contracts
Samples: Strategic Collaboration, Option and License Agreement (Akcea Therapeutics, Inc.), Strategic Collaboration, Option and License Agreement (Akcea Therapeutics, Inc.), Strategic Collaboration, Option and License Agreement (Akcea Therapeutics, Inc.)
Akcea: Special Consequences of Certain Terminations. If (A) Novartis terminates the Agreement under Section 11.2.1 or Section 11.2.7 or (B) Akcea terminates this Agreement under Section 11.2.2(b), Section 11.2.3(b), Section 11.2.5, Section 11.2.6, or Section 11.2.7, then, in addition to the terms set forth in Section 11.3.1, the following additional terms will also apply but only with respect to the Terminated Product:
(a) Novartis will and hereby does grant to Akcea:
(i) a sublicensable, worldwide, exclusive license or sublicense, as the case may be, under all Novartis Technology (excluding Novartis Background Technology) Controlled by Novartis as of the date of such termination that Covers the Terminated Product as of such date;
(ii) a sublicensable, worldwide, non-exclusive royalty-bearing license or sublicense, as the case may be, under all Novartis Background Technology Controlled by Novartis as of the date of such termination that Covers the Terminated Product as of such date; provided, however, that Akcea will not sublicense to [***] any Novartis Background Know-How claiming or covering [***] without Novartis’ prior written consent (such consent not to be unreasonably withheld, delayed or conditioned); and
(iii) in each case solely to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Terminated Product. Novartis will execute confirmatory license grants of the licenses granted to Akcea under this Section 11.3.2(a) within [***] ([***]) calendar days following the effective date of termination. If, after the effective date of such termination, Akcea or any of its Affiliates or Sublicensees Commercializes a Terminated Product previously licensed to Novartis under Section 5.1.1 or Section 5.1.2 (as applicable), then Akcea will pay Novartis a mutually * ***Confidential Treatment Requested agreed royalty on terms to be negotiated in good faith.
(b) Within [***] ([***]) calendar days following the date of termination, Novartis will deliver to Akcea for use with respect to the Development and Commercialization of the Terminated Product, any Know-How, data, results, regulatory information, pricing and market access strategy information, health economic study information, material communications with payors, regulatory filings in the possession of Novartis, or copies thereof, as of the date of such termination that relate solely to such Terminated Product;
(c) Within [***] ([***]) calendar days following the date of termination, Novartis will grant to Akcea an exclusive, royalty-free, fully paid up license under any Trademarks that are specific to a Terminated Product solely for use with such Terminated Product;
(d) Akcea will control and be responsible for all aspects of the Prosecution and Maintenance of all Akcea Product-Specific Patents and Jointly-Owned Program Patents and Novartis will provide Akcea with (and will instruct its counsel to provide Akcea with) all of the information and records in Novartis’ and its counsel’s possession related to the Prosecution and Maintenance of such Akcea Product-Specific Patents and Jointly-Owned Program Patents, in each case only in respect of the Terminated Product;
(e) If requested by Akcea, Novartis will sell to Akcea all remaining API or Finished Drug Product in Novartis’ possession at a price equal to [***] (or [***]) at the time such material was [***]; and
(f) Akcea may request Novartis to support (or cause to be supported by Novartis’ CMO) a technology transfer to Akcea (or Akcea’s designated Third Party supplier) of any technology, information and data reasonably related to Novartis’ or such CMO’s manufacturing and supply of API and/or Finished Drug Product for such Product, and if so requested, Novartis will, at no cost to Akcea for the first [***] hours of Novartis’ time, support (or cause to be supported by Novartis’ CMO) such a technology transfer and Novartis will (or will cause Novartis’ CMO to) continue to (i) provide reasonable support and cooperation with Akcea’s regulatory filings and interactions with Regulatory Authorities related to Novartis’ or such CMO’s API and/or Finished Drug Product manufacturing (including any required inspections), and (ii) supply (or cause to be supplied by Novartis’ CMO) API and/or Finished Drug Product to Akcea, at a price equal to [***] ([***]) at the time such material was [***], for a * ***Confidential Treatment Requested period of up to [***] ([***]) months to enable Akcea to identify and contract with a suitable Third Party API and/or Finished Drug Product manufacturer.
Appears in 1 contract
Samples: Strategic Collaboration, Option and License Agreement (Ionis Pharmaceuticals Inc)