Representations and Warranties of Alnylam. Except as provided in Schedule G, Alnylam represents and warrants to MedCo that as of the Effective Date: (a) Alnylam is the sole and exclusive owner of, or otherwise has the right to license to MedCo as set forth in this Agreement, pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.3), the Alnylam Technology. (b) All of the Alnylam Technology licensed to MedCo hereunder in the Territory that is solely and exclusively owned by Alnylam or its Affiliates is free and clear of liens, charges or encumbrances, other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to MedCo under this Agreement. (c) The Alnylam Technology and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the Licensed Products. 9.2.2 Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Patent Rights listed in Schedule C to grant the licenses to such Alnylam Patent Rights granted to MedCo pursuant to this Agreement. (a) To Alnylam’s knowledge, Schedule C-1 sets forth a complete and accurate list of the Alnylam Core Technology Patent Rights. (b) To Alnylam’s knowledge, Schedule C-2 sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights. (c) Schedules C-1 and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights owned, either solely or jointly, by Alnylam or its Affiliates. (d) To Alnylam’s knowledge, Schedules C-1 and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights licensed, either exclusively or nonexclusively, to Alnylam or its Affiliates. (e) To Alnylam’s knowledge, each issued Alnylam Patent Right remains in full force and effect. (f) Alnylam or its Affiliates have timely paid all filing and renewal fees payable with respect to such Alnylam Patent Rights for which Alnylam controls prosecution and maintenance. (g) Schedules C-1 and C-2 indicate whether each Alnylam Patent Right is owned exclusively by Alnylam or its Affiliates, is owned jointly by Alnylam and one or more Affiliates or Third Parties, or is licensed to Alnylam or its Affiliates. (h) For each Alnylam Patent Right that is owned, but not owned exclusively, by Alnylam or its Affiliates, or that is licensed to Alnylam or its Affiliates, Schedules C-1 and C-2 identify the Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent Right. (i) For each Alnylam Product-Specific Patent Right that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-2 indicates the non-exclusive nature of the license. (j) For each Alnylam Core Technology Patent Right family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-1 indicates the non-exclusive nature of the license. (k) Alnylam or its Affiliates is/are the sole and exclusive owner(s) of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. (l) To Alnylam’s knowledge, Schedule C-3 sets forth a complete and accurate list of the Patent Rights licensed to Alnylam pursuant to the Additional Alnylam In-Licenses and which, if MedCo exercises its option pursuant to Section 6.4.2.3 with respect to the relevant Additional Alnylam In-License on the Effective Date, would be considered “Controlled” by Alnylam. (a) To Alnylam’s knowledge, the Alnylam Product-Specific Patent Rights, are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged or threatened to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right (including, by way of example, through opposition or the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority). (b) Alnylam has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its filing, prosecution and maintenance of the Alnylam Patent Rights for which Alnylam controls filing, prosecution and maintenance. (a) Section A and Section C of Schedule D sets forth a complete and accurate list of all agreements between Alnylam or any of its Affiliates, on the one hand, and a Third Party(ies), on the other hand, entered into on or prior to the Effective Date and pursuant to which Alnylam or any of its Affiliates licenses or acquires any intellectual property rights owned or controlled by Alnylam or its Affiliates which are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products in the Field. (b) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or Commercialize Licensed Products in the Field in the Territory, except for the non-exclusive licenses granted to the Third Parties pursuant to the Existing Alnylam Third Party Agreements.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Representations and Warranties of Alnylam. Except as provided in Schedule G, Alnylam represents and warrants to MedCo that as of the Effective Date:
(a) Alnylam is the sole and exclusive owner of, or otherwise has the right to license to MedCo as set forth in this Agreement, pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.3), the Alnylam Technology.
(b) All of the Alnylam Technology licensed to MedCo hereunder in the Territory that is solely and exclusively owned by Alnylam or its Affiliates is free and clear of liens, charges or encumbrances, other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to MedCo under this Agreement.
(c) The Alnylam Technology and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the Licensed Products.
9.2.2 Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Patent Rights listed in Schedule C to grant the licenses to such Alnylam Patent Rights granted to MedCo pursuant to this Agreement.
(a) To Alnylam’s 's knowledge, Schedule C-1 sets forth a complete and accurate list of the Alnylam Core Technology Patent Rights.
(b) To Alnylam’s 's knowledge, Schedule C-2 sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights.
(c) Schedules C-1 and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights owned, either solely or jointly, by Alnylam or its Affiliates.
(d) To Alnylam’s 's knowledge, Schedules C-1 and C-1and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights licensed, either exclusively or nonexclusively, to Alnylam or its Affiliates.
(e) To Alnylam’s 's knowledge, each issued Alnylam Patent Right remains in full force and effect.full
(f) Alnylam or its Affiliates have timely paid all filing and renewal fees payable with respect to such Alnylam Patent Rights for which Alnylam controls prosecution and maintenance.
(g) Schedules C-1 and C-2 indicate whether each Alnylam Patent Right is owned exclusively by Alnylam or its Affiliates, is owned jointly by Alnylam and one or more Affiliates or Third Parties, or is licensed to Alnylam or its Affiliates.
(h) For each Alnylam Patent Right that is owned, but not owned exclusively, by Alnylam or its Affiliates, or that is licensed to Alnylam or its Affiliates, Schedules C-1 and C-2 identify the Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent Right.
(i) For each Alnylam Product-Specific Patent Right that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-2 indicates the non-exclusive nature of the license.
(j) For each Alnylam Core Technology Patent Right family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-1 indicates the non-exclusive nature of the license.
(k) Alnylam or its Affiliates is/are the sole and exclusive owner(s) of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934all Patent Rights identified in Schedules C-1 or C-2 as being owned exclusively by Alnylam or its Affiliates and Alnylam Controls all other Patent Rights identified on such schedules.
(l) To Alnylam’s 's knowledge, Schedule C-3 sets forth a complete and accurate list of the Patent Rights licensed to Alnylam pursuant to the Additional Alnylam In-Licenses and which, if MedCo exercises its option pursuant to Section 6.4.2.3 with respect to the relevant Additional Alnylam In-License on the Effective Date, would be considered “Controlled” by Alnylam.
(a) To Alnylam’s 's knowledge, the Alnylam Product-Specific Patent Rights, are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged or threatened to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right (including, by way of example, through opposition or the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority).
(b) Alnylam has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its filing, prosecution and maintenance of the Alnylam Patent Rights for which Alnylam controls filing, prosecution and maintenance.
(a) Section A and Section C of Schedule D sets forth a complete and accurate list of all agreements between Alnylam or any of its Affiliates, on the one hand, and a Third Party(ies), on the other hand, entered into on or prior to the Effective Date and pursuant to which Alnylam or any of its Affiliates licenses or acquires any intellectual property rights owned or controlled by Alnylam or its Affiliates which are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products in the Field. (b) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or Commercialize Licensed Products in the Field in the Territory, except for the non-exclusive licenses granted to the Third Parties pursuant to the Existing Alnylam Third Party Agreements.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Medicines Co /De), License and Collaboration Agreement (Medicines Co /De)
Representations and Warranties of Alnylam. Except as provided in the Disclosure Schedule Gto this Section 10.1 (which Disclosure Schedule with respect to ALN-TTRsc is attached hereto as Schedule 10.1-1 and with respect to ALN-AT3 will be provided by Alnylam to Genzyme as part of the Option Data Package for ALN-AT3), Alnylam represents and warrants to MedCo that Genzyme that, with respect to ALN-AT3, as of the Effective Implementation Date, and, with respect to ALN-TTRsc, as of the Execution Date:
(a) 10.1.1. Alnylam is the sole and exclusive owner of, or otherwise has the right to license to MedCo as set forth in this Agreement, Controls pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.3)License, the Alnylam Technology.
(b) All , and all of the Alnylam Technology licensed to MedCo Genzyme hereunder in the Genzyme Territory and the Co-Co Territory that is solely and exclusively owned by Alnylam or its Affiliates is free and clear of liens, charges or encumbrances, encumbrances other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to MedCo Genzyme under this Agreementthese Co-Co License Terms.
(c) The Alnylam Technology and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the Licensed Products.
9.2.2 10.1.2. Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Patent Rights listed in Schedule C Technology to grant the licenses to such Alnylam Patent Rights Technology granted to MedCo Genzyme pursuant to this Agreementthese Co-Co License Terms.
10.1 3. (a) To Alnylam’s knowledge, Schedule C-1 sets forth a complete 1.2.14 and accurate list of the Alnylam Core Technology Patent Rights.
(b) To Alnylam’s knowledge, Schedule C-2 sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights.
(c) Schedules C-1 and C-2 1.2.19 collectively set forth a complete and accurate list of the Alnylam Patent Rights Patents owned, either solely or jointly, by Alnylam or its Affiliates.
(d) To Alnylam, and to Alnylam’s knowledge, Schedules C-1 Schedule 1.2.14 and C-2 Schedule 1.2.19 collectively set forth a complete and accurate list of the Alnylam Patent Rights Patents licensed, either exclusively or nonexclusively, to Alnylam or its Affiliates.
Alnylam, (eb) To to Alnylam’s knowledge, each issued Alnylam Patent Right remains in full force and effect.
(f) Alnylam or its Affiliates have timely paid all filing effect and renewal fees payable with respect to such Alnylam Patent Rights for which Alnylam controls prosecution and maintenance.
(g) Schedules C-1 and C-2 indicate whether each Alnylam Patent Right is owned exclusively by Alnylam or its Affiliates, is owned jointly by Alnylam and one or more Affiliates or Third Parties, or is licensed to Alnylam or its Affiliates.
(h) For each Alnylam Patent Right that is owned, but not owned exclusively, by Alnylam or its Affiliates, or that is licensed to Alnylam or its Affiliates, Schedules C-1 and C-2 identify the Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent Right.
(i) For each Alnylam Product-Specific Patent Right that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-2 indicates the non-exclusive nature of the license.
(j) For each Alnylam Core Technology Patent Right family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-1 indicates the non-exclusive nature of the license.
(k) Alnylam or its Affiliates is/are the sole and exclusive owner(s) of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
(l) To Alnylam’s knowledge, Schedule C-3 sets forth a complete and accurate list of the Patent Rights licensed to Alnylam pursuant to the Additional Alnylam In. CO-Licenses and which, if MedCo exercises its option pursuant to Section 6.4.2.3 with respect to the relevant Additional Alnylam In-License on the Effective Date, would be considered “Controlled” by Alnylam.
(a) To Alnylam’s knowledge, the Alnylam Product-Specific Patent Rights, are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged or threatened to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right (including, by way of example, through opposition or the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority).
(b) Alnylam has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its filing, prosecution and maintenance of the Alnylam Patent Rights for which Alnylam controls filing, prosecution and maintenance.
(a) Section A and Section C of Schedule D sets forth a complete and accurate list of all agreements between Alnylam or any of its Affiliates, on the one hand, and a Third Party(ies), on the other hand, entered into on or prior to the Effective Date and pursuant to which Alnylam or any of its Affiliates licenses or acquires any intellectual property rights owned or controlled by Alnylam or its Affiliates which are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products in the Field. (b) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or Commercialize Licensed Products in the Field in the Territory, except for the non-exclusive licenses granted to the Third Parties pursuant to the Existing Alnylam Third Party Agreements.CO LICENSE TERMS
Appears in 1 contract
Samples: Master Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Representations and Warranties of Alnylam. Except as provided in Schedule G9.1 (Disclosure Schedule) with respect to each Global AT3 Licensed Product, Alnylam represents and warrants to MedCo Genzyme that as of the Effective Date:
(a) Alnylam is the sole and exclusive owner of, or otherwise has the right to license to MedCo as set forth in this Agreement, pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at Implementation Date for such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.3), the Alnylam Technology.
(b) All of the Alnylam Technology licensed to MedCo hereunder in the Territory that is solely and exclusively owned by Alnylam or its Affiliates is free and clear of liens, charges or encumbrances, other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to MedCo under this Agreement.
(c) The Alnylam Technology and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the Global AT3 Licensed Products.
9.2.2 Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Patent Rights listed in Schedule C to grant the licenses to such Alnylam Patent Rights granted to MedCo pursuant to this Agreement.
(a) To Alnylam’s knowledge, Schedule C-1 sets forth a complete and accurate list of the Alnylam Core Technology Patent Rights.
(b) To Alnylam’s knowledge, Schedule C-2 sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights.
(c) Schedules C-1 and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights owned, either solely or jointly, by Alnylam or its Affiliates.
(d) To Alnylam’s knowledge, Schedules C-1 and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights licensed, either exclusively or nonexclusively, to Alnylam or its Affiliates.
(e) To Alnylam’s knowledge, each issued Alnylam Patent Right remains in full force and effect.
(f) Alnylam or its Affiliates have timely paid all filing and renewal fees payable with respect to such Alnylam Patent Rights for which Alnylam controls prosecution and maintenance.
(g) Schedules C-1 and C-2 indicate whether each Alnylam Patent Right is owned exclusively by Alnylam or its Affiliates, is owned jointly by Alnylam and one or more Affiliates or Third Parties, or is licensed to Alnylam or its Affiliates.
(h) For each Alnylam Patent Right that is owned, but not owned exclusively, by Alnylam or its Affiliates, or that is licensed to Alnylam or its Affiliates, Schedules C-1 and C-2 identify the Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent Right.
(i) For each Alnylam Product-Specific Patent Right that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-2 indicates the non-exclusive nature of the license.
(j) For each Alnylam Core Technology Patent Right family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-1 indicates the non-exclusive nature of the license.
(k) Alnylam or its Affiliates is/are the sole and exclusive owner(s) of : CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
9.1.1 Alnylam is the sole and exclusive owner of, or otherwise Controls pursuant to an Alnylam In-License, the Alnylam Technology, and all of the Alnylam Technology licensed to Genzyme hereunder in the Licensed Territory that is solely and exclusively owned by Alnylam is free and clear of liens, charges or encumbrances other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to Genzyme under this Agreement.
9.1.2 Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Technology to grant the licenses to such Alnylam Technology granted to Genzyme pursuant to this Agreement.
9.1.3 (la) To Alnylam’s knowledge, Schedule C-3 sets 1.2.8 and Schedule 1.2.13 collectively set forth a complete and accurate list of the Alnylam Patents owned, either solely or jointly, by Alnylam, and to Alnylam’s knowledge, Schedule 1.2.8 and Schedule 1.2.13 collectively set forth a complete and accurate list of the Alnylam Patents licensed, either exclusively or nonexclusively, to Alnylam, (b) to Alnylam’s knowledge, each issued Alnylam Patent Rights licensed to remains in full force and effect and (c) Alnylam pursuant to the Additional Alnylam In-Licenses or its Affiliates have timely paid all filing and which, if MedCo exercises its option pursuant to Section 6.4.2.3 renewal fees payable with respect to such Alnylam Patents for which Alnylam controls prosecution and maintenance. Schedule 1.2.8 and Schedule 1.2.13 indicate whether each Alnylam Patent is owned exclusively by Alnylam, is owned jointly by Alnylam and one or more Third Parties, or is licensed to Alnylam. For each Alnylam Patent that is owned, but not owned exclusively, by Alnylam, or that is licensed to Alnylam, Schedule 1.2.8 and Schedule 1.2.13 identify the relevant Additional Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent. For each Alnylam Product-Specific Patent that is licensed, but not exclusively licensed, to Alnylam, Schedule 1.2.13 indicates the non-exclusive nature of the license. For each Alnylam Core Technology Patent family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam, Schedule 1.2.8 indicates the non-exclusive nature of the license. Alnylam is the sole and exclusive owner of all Patent Rights identified in Schedule 1.2.8 and Schedule 1.2.13 as being owned exclusively by Alnylam and Controls all other Patent Rights identified on the Effective Date, would be considered “Controlled” by Alnylamsuch schedules.
(a) 9.1.4 To Alnylam’s knowledge, the Alnylam Product-Specific Patent RightsPatents, are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged or threatened to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right (including, by way of example, through opposition or the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority).
(b) 9.1.5 Alnylam has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its the filing, prosecution and maintenance of the Alnylam Patent Rights for which Alnylam controls filing, prosecution and maintenancePatents. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
(a) Section A 9.1.6 Alnylam owns or Controls all Know-How that is or has been used by Alnylam in the Development and Section C Manufacture of Schedule D sets forth a complete and accurate list of all agreements between Alnylam or any of its Affiliates, on the one handsuch Global AT3 Licensed Products, and a Third Party(ieshas sufficient legal or beneficial title and ownership of, or sufficient license rights under such Know-How to transfer Know-How to Genzyme as provided in Section 6.4 of the Master Agreement (Transfer of Manufacturing Know-How), on the other hand, entered into on or prior to the Effective Date and pursuant to which Alnylam or any of its Affiliates licenses or acquires any intellectual property rights owned or controlled by Alnylam or its Affiliates which are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products in the Field. (b) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or Commercialize Licensed Products in the Field in the Territory, except for the non-exclusive licenses granted to the Third Parties pursuant to the Existing Alnylam Third Party Agreements.
Appears in 1 contract
Samples: Global License Agreement (Alnylam Pharmaceuticals, Inc.)
Representations and Warranties of Alnylam. Except as provided in Schedule G10.2, Alnylam represents and warrants to MedCo Genzyme that as of the Effective Date:
(a) 10.2.1 Alnylam is the sole and exclusive owner of, or otherwise has the right to license to MedCo as set forth in this Agreement, Controls pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.37.4.2), the Alnylam Technology.
(b) All , and all of the Alnylam Technology licensed to MedCo Genzyme hereunder in the Genzyme Territory that is solely and exclusively owned by Alnylam or its Affiliates is free and clear of liens, charges or encumbrances, encumbrances other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to MedCo Genzyme under this Agreement.
(c) The Alnylam Technology and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the Licensed Products.
9.2.2 10.2.2 Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Patent Rights listed in Schedule C Technology to grant the licenses to such Alnylam Patent Rights Technology granted to MedCo Genzyme pursuant to this Agreement.
(a) To Alnylam’s knowledge, Schedule C-1 sets forth a complete 1.9 and accurate list of the Alnylam Core Technology Patent Rights.
(b) To Alnylam’s knowledge, Schedule C-2 sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights.
(c) Schedules C-1 and C-2 1.16 collectively set forth a complete and accurate list of the Alnylam Patent Rights Patents owned, either solely or jointly, by Alnylam or its Affiliates.
(d) To Alnylam, and to Alnylam’s knowledge, Schedules C-1 Schedule 1.9 and C-2 Schedule 1.16 collectively set forth a complete and accurate list of the Alnylam Patent Rights Patents licensed, either exclusively or nonexclusively, to Alnylam or its Affiliates.
Alnylam, (eb) To to Alnylam’s knowledge, each issued Alnylam Patent Right remains in full force and effect.
effect and (fc) Alnylam or its Affiliates have timely paid all filing and renewal fees payable with respect to such Alnylam Patent Rights Patents for which Alnylam controls prosecution and maintenance.
(g) Schedules C-1 . Schedule 1.9 and C-2 Schedule 1.16 indicate whether each Alnylam Patent Right is owned exclusively by Alnylam or its AffiliatesAlnylam, is owned jointly by Alnylam and one or more Affiliates or Third Parties, or is licensed to Alnylam or its Affiliates.
(h) Alnylam. For each Alnylam Patent Right that is owned, but not owned exclusively, by Alnylam or its AffiliatesAlnylam, or that is licensed to Alnylam or its AffiliatesAlnylam, Schedules C-1 Schedule 1.9 and C-2 Schedule 1.16 identify the Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent Right.
(i) Patent. For each Alnylam Product-Specific Patent Right that is licensed, but not exclusively licensed, to Alnylam or its AffiliatesAlnylam, Schedule C-2 1.16 indicates the non-exclusive nature of the license.
(j) . For each Alnylam Core Technology Patent Right family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam or its AffiliatesAlnylam, Schedule C-1 1.9 indicates the non-exclusive nature of the license.
(k) . Alnylam or its Affiliates is/are is the sole and exclusive owner(s) owner of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934all Patent Rights identified in Schedule 1.9 and Schedule 1.16 as being owned exclusively by Alnylam and Controls all other Patent Rights identified on such schedules.
(l) To Alnylam’s knowledge, Schedule C-3 sets forth a complete and accurate list of the Patent Rights licensed to Alnylam pursuant to the Additional Alnylam In-Licenses and which, if MedCo exercises its option pursuant to Section 6.4.2.3 with respect to the relevant Additional Alnylam In-License on the Effective Date, would be considered “Controlled” by Alnylam.
(a) 10.2.4 To Alnylam’s knowledge, the Alnylam Product-Specific Patent RightsPatents, are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged or threatened to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right (including, by way of example, through opposition or the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority).
(b) 10.2.5 Alnylam has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its the filing, prosecution and maintenance of the Alnylam Patent Rights for which Alnylam controls filing, prosecution and maintenanceRights.
(a) 10.2.6 Alnylam owns or Controls all Know-How that is or has been used by Alnylam in the Development and Manufacture of the Licensed Products, and has sufficient legal or beneficial title and ownership of, or sufficient license rights under such Know-How to transfer Know-How to Genzyme as provided in Section A and Section C of 6.2.
10.2.7 Schedule D 1.47 sets forth a complete and accurate list of the Existing Alnylam In-Licenses. Alnylam Controls all agreements between Know-How and Patent Rights licensed to Alnylam or any of its Affiliates, on under the one hand, and a Third Party(ies), on the other hand, entered into on or prior to the Effective Date and pursuant to which Existing Alnylam or any of its Affiliates licenses or acquires any intellectual property rights owned or controlled by Alnylam or its Affiliates which are reasonably In-Licenses that is necessary or useful for Genzyme to Develop, Manufacture or Commercialize Licensed Products in the Field. (b) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or and/or Commercialize Licensed Products in the Field in the Genzyme Territory. Without limiting the generality of the foregoing, except for the nonAlnylam has obtained all necessary consents and fulfilled all necessary conditions, if any, to sublicense to Genzyme under this Agreement such Know-exclusive licenses granted How and Patent Rights licensed to the Third Parties Alnylam under Existing Alnylam In-Licenses. At such time that an Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 7.4.2, Alnylam will Control all Know-How, if any, and Patent Rights licensed to Alnylam under such Additional Alnylam In-License that is necessary or useful for Genzyme to Develop, Manufacture and/or Commercialize Licensed Products in the Field in the Genzyme Territory.
10.2.8 To Alnylam’s knowledge, neither Alnylam nor its Affiliates are in breach or default under any Existing Alnylam In-License or Additional Alnylam In-License, and neither Alnylam nor its Affiliates have received any written notice of breach or default with respect to any Existing Alnylam In-License or Additional Alnylam In-License.
10.2.9 Alnylam has obtained from all inventors of Alnylam Technology owned by Alnylam valid and enforceable agreements assigning to Alnylam each such inventor’s entire right, title and interest in and to all such Alnylam Technology.
10.2.10 No Alnylam Technology existing as of the Effective Date is subject to any funding agreement with any government or Governmental Authority.
10.2.11 To Alnylam’s knowledge, the use, Development, Manufacture or Commercialization by Alnylam or Genzyme (or their respective Related Parties) of any Licensed Product as formulated and manufactured as of the Effective Date, or as intended to be formulated and manufactured as of the Effective Date (a) does not and will not infringe any issued patent of any Third Party Agreementsor (b) will not infringe the claims of any published Third Party patent application when and if such claims were to issue in their current form.
10.2.12 There is no (a) claim, demand, suit, proceeding, arbitration, inquiry, investigation or other legal action of any nature, civil, criminal, regulatory or otherwise, pending or, to Alnylam’s knowledge, threatened against Alnylam or any of its Affiliates or (b) judgment or settlement against or owed by Alnylam or any of its Affiliates, in each case in connection with the Alnylam Technology or any Licensed Product.
Appears in 1 contract
Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Representations and Warranties of Alnylam. Except as provided in the Disclosure Schedule Gto this Section 9.1 (which Disclosure Schedule with respect to any Global Licensed Product will be provided by Alnylam to Genzyme as part of the Option Data Package for such Global Licensed Product), with respect to each Global Licensed Product, Alnylam represents and warrants to MedCo Genzyme that as of the Effective DateImplementation Date for such Global Licensed Product:
(a) 9.1.1 Alnylam is the sole and exclusive owner of, or otherwise has the right to license to MedCo as set forth in this Agreement, Controls pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.3)License, the Alnylam Technology.
(b) All , and all of the Alnylam Technology licensed to MedCo Genzyme hereunder in the Licensed Territory that is solely and exclusively owned by Alnylam or its Affiliates is free and clear of liens, charges or encumbrances, encumbrances other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to MedCo Genzyme under this Agreementthese Global License Terms.
(c) The Alnylam Technology and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the Licensed Products.
9.2.2 9.1.2 Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Patent Rights listed in Schedule C Technology to grant the licenses to such Alnylam Patent Rights Technology granted to MedCo Genzyme pursuant to this Agreementthese Global License Terms.
9.1.3 (a) To Alnylam’s knowledge, Schedule C-1 sets forth a complete 1.2.8 and accurate list of the Alnylam Core Technology Patent Rights.
(b) To Alnylam’s knowledge, Schedule C-2 sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights.
(c) Schedules C-1 and C-2 1.2.15 collectively set forth a complete and accurate list of the Alnylam Patent Rights Patents owned, either solely or jointly, by Alnylam or its Affiliates.
(d) To Alnylam, and to Alnylam’s knowledge, Schedules C-1 Schedule 1.2.8 and C-2 Schedule 1.2.15 collectively set forth a complete and accurate list of the Alnylam Patent Rights Patents licensed, either exclusively or nonexclusively, to Alnylam or its Affiliates.
Alnylam, (eb) To to Alnylam’s knowledge, each issued Alnylam Patent Right remains in full force and effect.
effect and (fc) Alnylam or its Affiliates have timely paid all filing and renewal fees payable with respect to such Alnylam Patent Rights Patents for which Alnylam controls prosecution and maintenance.
(g) Schedules C-1 . Schedule 1.2.8 and C-2 Schedule 1.2.15 indicate whether each Alnylam Patent Right is owned exclusively by Alnylam or its AffiliatesAlnylam, is owned jointly by Alnylam and one or more Affiliates or Third Parties, or is licensed to Alnylam or its Affiliates.
(h) Alnylam. For each Alnylam Patent Right that is owned, but not owned exclusively, by Alnylam or its AffiliatesAlnylam, or that is licensed to Alnylam or its AffiliatesAlnylam, Schedules C-1 Schedule 1.2.8 and C-2 Schedule 1.2.15 identify the Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent Right.
(i) Patent. For each Alnylam Product-Specific Patent Right that is licensed, but not exclusively licensed, to Alnylam or its AffiliatesAlnylam, Schedule C-2 1.2.15 indicates the non-exclusive nature of the license.
(j) . For each Alnylam Core Technology Patent Right family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam or its AffiliatesAlnylam, Schedule C-1 1.2.8 indicates the non-exclusive nature of the license.
(k) . Alnylam or its Affiliates is/are is the sole and exclusive owner(s) owner of all Patent Rights identified in Schedule 1.2.8 and Schedule 1.2.15 as being owned exclusively by Alnylam and Controls all other Patent Rights identified on such schedules. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
(l) To Alnylam’s knowledge, Schedule C-3 sets forth a complete and accurate list of the Patent Rights licensed to Alnylam pursuant to the Additional Alnylam In-Licenses and which, if MedCo exercises its option pursuant to Section 6.4.2.3 with respect to the relevant Additional Alnylam In-License on the Effective Date, would be considered “Controlled” by Alnylam.
(a) To Alnylam’s knowledge, the Alnylam Product-Specific Patent Rights, are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged or threatened to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right (including, by way of example, through opposition or the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority).
(b) Alnylam has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its filing, prosecution and maintenance of the Alnylam Patent Rights for which Alnylam controls filing, prosecution and maintenance.
(a) Section A and Section C of Schedule D sets forth a complete and accurate list of all agreements between Alnylam or any of its Affiliates, on the one hand, and a Third Party(ies), on the other hand, entered into on or prior to the Effective Date and pursuant to which Alnylam or any of its Affiliates licenses or acquires any intellectual property rights owned or controlled by Alnylam or its Affiliates which are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products in the Field. (b) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or Commercialize Licensed Products in the Field in the Territory, except for the non-exclusive licenses granted to the Third Parties pursuant to the Existing Alnylam Third Party Agreements.
Appears in 1 contract
Samples: Master Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Representations and Warranties of Alnylam. Except as provided in Schedule G, Alnylam represents and warrants to MedCo that as of the Effective Date:
(a) Alnylam is the sole and exclusive owner of, or otherwise has the right to license to MedCo as set forth in this Agreement, pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.3), the Alnylam TechnologyCERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
(b) All of the Alnylam Technology licensed to MedCo hereunder in the Territory that is solely and exclusively owned by Alnylam or its Affiliates is free and clear of liens, charges or encumbrances, other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to MedCo under this Agreement.
(c) The Alnylam Technology and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the Licensed Products.
9.2.2 Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Patent Rights listed in Schedule C to grant the licenses to such Alnylam Patent Rights granted to MedCo pursuant to this Agreement.
(a) To Alnylam’s knowledge, Schedule C-1 sets forth a complete and accurate list of the Alnylam Core Technology Patent Rights.
(b) To Alnylam’s knowledge, Schedule C-2 sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights.
(c) Schedules C-1 and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights owned, either solely or jointly, by Alnylam or its Affiliates.
(d) To Alnylam’s knowledge, Schedules C-1 and C-1and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights licensed, either exclusively or nonexclusively, to Alnylam or its Affiliates.
(e) To Alnylam’s knowledge, each issued Alnylam Patent Right remains in full force and effect.
(f) Alnylam or its Affiliates have timely paid all filing and renewal fees payable with respect to such Alnylam Patent Rights for which Alnylam controls prosecution and maintenance.
(g) Schedules C-1 and C-2 indicate whether each Alnylam Patent Right is owned exclusively by Alnylam or its Affiliates, is owned jointly by Alnylam and one or more Affiliates or Third Parties, or is licensed to Alnylam or its Affiliates.
(h) For each Alnylam Patent Right that is owned, but not owned exclusively, by Alnylam or its Affiliates, or that is licensed to Alnylam or its Affiliates, Schedules C-1 and C-2 identify the Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent Right.
(i) For each Alnylam Product-Specific Patent Right that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-2 indicates the non-exclusive nature of the license.
(j) For each Alnylam Core Technology Patent Right family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-1 indicates the non-exclusive nature of the license.
(k) Alnylam or its Affiliates is/are the sole and exclusive owner(s) of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934all Patent Rights identified in Schedules C-1 or C-2 as being owned exclusively by Alnylam or its Affiliates and Alnylam Controls all other Patent Rights identified on such schedules.
(l) To Alnylam’s knowledge, Schedule C-3 sets forth a complete and accurate list of the Patent Rights licensed to Alnylam pursuant to the Additional Alnylam In-Licenses and which, if MedCo exercises its option pursuant to Section 6.4.2.3 with respect to the relevant Additional Alnylam In-License on the Effective Date, would be considered “Controlled” by Alnylam.
(a) To Alnylam’s knowledge, the Alnylam Product-Specific Patent Rights, are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged or threatened to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right (including, by way of example, through opposition or the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
(b) Alnylam has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its filing, prosecution and maintenance of the Alnylam Patent Rights for which Alnylam controls filing, prosecution and maintenance.
(a) Section A and Section C of Schedule D sets forth a complete and accurate list of all agreements between Alnylam or any of its Affiliates, on the one hand, and a Third Party(ies), on the other hand, entered into on or prior to the Effective Date and pursuant to which Alnylam or any of its Affiliates licenses or acquires any intellectual property rights owned or controlled by Alnylam or its Affiliates which are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products in the Field. (b) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or Commercialize Licensed Products in the Field in the Territory, except for the non-exclusive licenses granted to the Third Parties pursuant to the Existing Alnylam Third Party Agreements.
Appears in 1 contract
Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)