License to MyoKardia. Subject to the terms and conditions of this Agreement, including Section 3.3, Sanofi hereby grants to MyoKardia the following licenses (which shall be sub-licensable solely as provided in Section 3.4 and shall remain in effect unless and until terminated in accordance with this Agreement): (a) a co-exclusive (solely with Sanofi and its Affiliates and, if elected by Sanofi, its permitted subcontractors), worldwide, royalty-free license under both the Sanofi Licensed Technology and Sanofi’s rights in the Joint Program Technology, solely to the extent such Licensed Technology or Joint Program Technology is necessary, to perform MyoKardia’s activities under the Research Plan and/or the POC Development Plans during the Initial R&D Term; (b) a co-exclusive (solely with Sanofi and its Affiliates and, if elected by Sanofi, its permitted subcontractors) license under both the Sanofi Licensed Technology and Sanofi’s rights in the Joint Program Technology to (i) Develop Compounds and Products in the Field (which shall be conducted solely in accordance with this Agreement) and (ii) Develop companion diagnostics for Products in the Field (which shall be conducted in accordance with Section 5.2(e)); (c) an exclusive (including with regards to Sanofi and its Affiliates), royalty-bearing license under both the Sanofi Licensed Technology and Sanofi’s rights in the Joint Program Technology to offer for sale, sell, import and otherwise Commercialize (i) Compounds and Products in the Field in the Retained Territory and (ii) companion diagnostics for Products in the Field in the Retained Territory; (d) a co-exclusive (solely with Sanofi and its Affiliates and, if desired by Sanofi, its permitted subcontractors) license under both the Sanofi Licensed Technology and Sanofi’s rights in the Joint Program Technology to Manufacture and have Manufactured Compounds and Products worldwide, provided that MyoKardia shall have the right to use such Compounds and Products so Manufactured solely in connection with the exercising of its rights under Section 3.2(a), Section 3.2(b) or Section 3.2(c); and (e) a license and right of reference, with the right to grant further rights of reference as provided in Section 3.4, under the Regulatory Approvals and any other Regulatory Materials that Sanofi or its Affiliates may Control solely in connection with its development, manufacture or commercialization of Compounds and Products in the Field, which license and right is for the sole purpose of the exercising of MyoKardia’s rights under Section 3.2(a), Section 3.2(b), Section 3.2(c) or Section 3.2(d) (which license and right of reference shall be exclusive or co-exclusive in a manner analogous to Section 3.2(a), Section 3.2(b), Section 3.2(c) or Section 3.2(d), as applicable). For the avoidance of doubt, the licenses granted by Sanofi to MyoKardia under this Agreement do not include any rights for MyoKardia to develop, make, have made, sell, offer for sale or otherwise commercialize any proprietary compound of Sanofi that is not a Compound, as a single agent product or as part of any Combination Product. In addition, the grant of the foregoing licenses to MyoKardia shall not be construed to impose any obligation to disclose any Know-How other than as expressly set forth herein. MyoKardia shall not use any proprietary assay to the extent Controlled by Sanofi or its Affiliates that are identified as proprietary Sanofi assays in the Research Plan or applicable Development Plan and provided to MyoKardia by Sanofi hereunder for any purpose other than to conduct the activities allocated to MyoKardia under the Research Plan or POC Development Plan as specifically set forth therein, but in no event shall MyoKardia be precluded from using publicly available assays for any purpose.
Appears in 2 contracts
Samples: License and Collaboration Agreement (MyoKardia Inc), License and Collaboration Agreement (MyoKardia Inc)
License to MyoKardia. Subject to the terms (i) All licenses and conditions of this Agreement, including Section 3.3, Sanofi hereby grants other rights granted to MyoKardia the following licenses (which shall be sub-licensable solely as provided in Section 3.4 and shall remain in effect unless and until terminated in accordance with this Agreement):
(a) a co-exclusive (solely with Sanofi and its Affiliates and, if elected by Sanofi, its permitted subcontractors), worldwide, royalty-free license under both the Sanofi Licensed Technology and Sanofi’s rights in of reference shall survive the Joint Program Technology, solely termination of this Agreement. The licenses and other rights granted to MyoKardia under the extent such Sanofi Licensed Technology or and Joint Program Technology shall expand to include the HCM1 Products and the HCM2 Products in the Licensed Territory and the DCM1 Products worldwide.
(ii) Unless this Agreement is necessary, to perform MyoKardiaterminated by MyoKardia under Section 12.2(b) or 12.2(d) for Sanofi’s activities material breach or patent challenge or by Sanofi under the Research Plan and/or the POC Development Plans Section 12.2(a)(i) or Section 12.2(a)(iv) in its entirety during the Initial R&D Term;, the royalties due to Sanofi for the HCM1 Products and HCM2 Products in the United States under Section 9.6(c) shall continue to apply; provided that such royalties shall not apply on a Program-by-Program basis to the HCM1 Products or HCM2 Products if this Agreement is terminated under Section 12.2(a)(ii) for the HCM1 Program or HCM2 Program, respectively; provided further that royalties shall be due for Competing Products for which clinical development has commenced and/or commercialized by such Party or the applicable Affiliate as of the effective date of such termination that are HCM1 Products or HCM2 Products if such royalties would otherwise be due under Section 3.7(c)(ii)(y) in the absence of the termination of the Agreement. In the event that a royalty is not due under this clause (b)(ii) with respect to a given HCM1 Product or HCM2 Product, then the royalties described in Section 12.3(b)(iii) shall apply to the Retained Territory with respect to such Product.
(biii) Solely for those Products containing Compounds whose composition of matter is claimed by a co-exclusive Sanofi Licensed Patent or Products containing a [***] the design of which is claimed by a Sanofi Licensed Patent (solely with the “Sanofi Proprietary Device Component”), MyoKardia shall pay to Sanofi a royalty of [***] percent ([***]%) of Net Sales (calculated based on sales by MyoKardia and its Affiliates andand (Sub)licensees and subject to any Combination Product adjustment as set forth in the definition of the Net Sales in Section 1.133) of such HCM1 Products and HCM2 Products outside the United States and of such DCM1 Products worldwide, if elected by Sanofiin each case for the applicable Royalty Term therefor and otherwise on the terms (including applicable royalty offset and reductions) set forth in ARTICLE 9, its permitted subcontractors) plus any amounts owed to Third Parties under license agreements granting Sanofi a license under both such Third Party’s Patent Rights or Know-How, to the Sanofi Licensed Technology and Sanofi’s rights extent agreed by the Parties under Section 10.7; provided, however, in the Joint Program Technology to case of termination of this Agreement by Sanofi under Section 12.2(b) for MyoKardia’s material breach, or by Sanofi under Section 12.2(a)(iv) for a Change of Control in which there is a Competing Product of the Acquiror (i) Develop Compounds and Products in or of any of the Field (which shall be conducted solely in accordance with this Agreement) and (ii) Develop companion diagnostics for Products in the Field (which shall be conducted in accordance with Section 5.2(e));
(c) an exclusive (including with regards to Sanofi and its Acquiror’s Affiliates), royalty-bearing license under both the MyoKardia shall instead pay to Sanofi Licensed Technology and Sanofi’s rights in the Joint Program Technology to offer for sale, sell, import and otherwise Commercialize a royalty of [***] percent (i[***]%) Compounds and Products in the Field in the Retained Territory and of Net Sales (ii) companion diagnostics for Products in the Field in the Retained Territory;
(d) a co-exclusive (solely with Sanofi calculated based on sales by MyoKardia and its Affiliates andand (Sub)licensees) of such HCM1 Products and HCM2 Products outside the United States and of such DCM1 Products worldwide , if desired by Sanofifor the applicable Royalty Term therefor and otherwise on the terms (including applicable royalty offset and reductions) set forth in ARTICLE 9, its permitted subcontractors) plus any amounts owed to Third Parties under license agreements granting Sanofi a license under both such Third Party’s Patent Rights or Know-How, to the * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission extent agreed by the Parties under Section 10.7. For clarity , in adjusting for Net Sales for any Combination Product containing a Sanofi Licensed Technology and Sanofi’s rights Proprietary Device Component, the adjustment mechanism in the Joint Program Technology to Manufacture and have Manufactured Compounds and Products worldwidedefinition of Net Sales shall apply, provided that MyoKardia shall have the right to use such Compounds and Products so Manufactured solely in connection with the exercising of its rights under Section 3.2(a)mutatis mutandis, Section 3.2(b) or Section 3.2(c); and
(e) a license and right of reference, with the right to grant further rights of reference as provided in Section 3.4, under the Regulatory Approvals and any other Regulatory Materials that Sanofi or its Affiliates may Control solely in connection with its development, manufacture or commercialization of Compounds and Products in the Field, which license and right is for the sole purpose calculation of the exercising of MyoKardia’s rights under Section 3.2(a), Section 3.2(b), Section 3.2(c) or Section 3.2(d) (which license and right of reference shall be exclusive or co-exclusive in a manner analogous to Section 3.2(a), Section 3.2(b), Section 3.2(c) or Section 3.2(d), as applicable). For the avoidance of doubt, the licenses granted by Sanofi to MyoKardia under this Agreement do not include any rights for MyoKardia to develop, make, have made, sell, offer for sale or otherwise commercialize any proprietary compound of Sanofi that is not a Compound, as a single agent product or as part of any Combination Product. In addition, the grant of the foregoing licenses to MyoKardia shall not be construed to impose any obligation to disclose any Know-How other than as expressly set forth herein. MyoKardia shall not use any proprietary assay to the extent Controlled by Sanofi or its Affiliates that are identified as proprietary Sanofi assays in the Research Plan or applicable Development Plan and provided to MyoKardia by Sanofi hereunder for any purpose other than to conduct the activities Net Sales allocated to MyoKardia under the Research Plan or POC Development Plan as specifically set forth therein, but in no event shall MyoKardia be precluded from using publicly available assays for any purposesuch Sanofi Proprietary Device Component .
Appears in 1 contract
Samples: License and Collaboration Agreement (MyoKardia Inc)
License to MyoKardia. Subject to the terms (i) All licenses and conditions of this Agreement, including Section 3.3, Sanofi hereby grants other rights granted to MyoKardia the following licenses (which shall be sub-licensable solely as provided in Section 3.4 and shall remain in effect unless and until terminated in accordance with this Agreement):
(a) a co-exclusive (solely with Sanofi and its Affiliates and, if elected by Sanofi, its permitted subcontractors), worldwide, royalty-free license under both the Sanofi Licensed Technology and Sanofi’s rights in of reference shall survive the Joint Program Technology, solely termination of this Agreement. The licenses and other rights granted to MyoKardia under the extent such Sanofi Licensed Technology or and Joint Program Technology shall expand to include the HCM1 Products and the HCM2 Products in the Licensed Territory and the DCM1 Products worldwide.
(ii) Unless this Agreement is necessary, to perform MyoKardiaterminated by MyoKardia under Section 12.2(b) or 12.2(d) for Sanofi’s activities material breach or patent challenge or by Sanofi under the Research Plan and/or the POC Development Plans Section 12.2(a)(i) or Section 12.2(a)(iv) in its entirety during the Initial R&D Term;, the royalties due to Sanofi for the HCM1 Products and HCM2 Products in the United States under Section 9.6(c) shall continue to apply; provided that such royalties shall not apply on a Program-by-Program basis to the HCM1 Products or HCM2 Products if this Agreement is terminated under Section 12.2(a)(ii) for the HCM1 Program or HCM2 Program, respectively; provided further that royalties shall be due for Competing Products for which clinical development has commenced and/or commercialized by such Party or the applicable Affiliate as of the effective date of such termination that are HCM1 Products or HCM2 Products if such royalties would otherwise be due under Section 3.7(c)(ii)(y) in the absence of the termination of the Agreement. In the event that a royalty is not due under this clause (b)(ii) with respect to a given HCM1 Product or HCM2 Product, then the royalties described in Section 12.3(b)(iii) shall apply to the Retained Territory with respect to such Product.
(biii) Solely for those Products containing Compounds whose composition of matter is claimed by a co-exclusive Sanofi Licensed Patent or Products containing a device the design of which is claimed by a Sanofi Licensed Patent (solely with the “Sanofi Proprietary Device Component”), MyoKardia shall pay to Sanofi a royalty of [***] percent ([***]%) of Net Sales (calculated based on sales by MyoKardia and its Affiliates andand (Sub)licensees and subject to any Combination Product adjustment as set forth in the definition of the Net Sales in Section 1.133) of such HCM1 Products and HCM2 Products outside the United States and of such DCM1 Products worldwide, if elected by Sanofiin each case for the applicable Royalty Term therefor and otherwise on the terms (including applicable royalty offset and reductions) set forth in ARTICLE 9, its permitted subcontractors) plus any amounts owed to Third Parties under license agreements granting Sanofi a license under both such Third Party’s Patent Rights or Know-How, to the Sanofi Licensed Technology and Sanofi’s rights extent agreed by the Parties under Section 10.7; provided, however, in the Joint Program Technology to case of termination of this Agreement by Sanofi under Section 12.2(b) for MyoKardia’s material breach, or by Sanofi under Section 12.2(a)(iv) for a Change of Control in which there is a Competing Product of the Acquiror (i) Develop Compounds and Products in or of any of the Field (which shall be conducted solely in accordance with this Agreement) and (ii) Develop companion diagnostics for Products in the Field (which shall be conducted in accordance with Section 5.2(e));
(c) an exclusive (including with regards to Sanofi and its Acquiror’s Affiliates), royalty-bearing license under both the MyoKardia shall instead pay to Sanofi Licensed Technology and Sanofi’s rights in the Joint Program Technology to offer for sale, sell, import and otherwise Commercialize a royalty of [***] percent (i[***]%) Compounds and Products in the Field in the Retained Territory and of Net Sales (ii) companion diagnostics for Products in the Field in the Retained Territory;
(d) a co-exclusive (solely with Sanofi calculated based on sales by MyoKardia and its Affiliates andand (Sub)licensees) of such HCM1 Products and HCM2 Products outside the United States and of such DCM1 Products worldwide , if desired by Sanofifor the applicable Royalty Term therefor and otherwise on the terms (including applicable royalty offset and reductions) set forth in ARTICLE 9, its permitted subcontractors) plus any amounts owed to Third Parties under license agreements granting Sanofi a license under both such Third Party’s Patent Rights or Know-How, to the * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission extent agreed by the Parties under Section 10.7. For clarity , in adjusting for Net Sales for any Combination Product containing a Sanofi Licensed Technology and Sanofi’s rights Proprietary Device Component, the adjustment mechanism in the Joint Program Technology to Manufacture and have Manufactured Compounds and Products worldwidedefinition of Net Sales shall apply, provided that MyoKardia shall have the right to use such Compounds and Products so Manufactured solely in connection with the exercising of its rights under Section 3.2(a)mutatis mutandis, Section 3.2(b) or Section 3.2(c); and
(e) a license and right of reference, with the right to grant further rights of reference as provided in Section 3.4, under the Regulatory Approvals and any other Regulatory Materials that Sanofi or its Affiliates may Control solely in connection with its development, manufacture or commercialization of Compounds and Products in the Field, which license and right is for the sole purpose calculation of the exercising of MyoKardia’s rights under Section 3.2(a), Section 3.2(b), Section 3.2(c) or Section 3.2(d) (which license and right of reference shall be exclusive or co-exclusive in a manner analogous to Section 3.2(a), Section 3.2(b), Section 3.2(c) or Section 3.2(d), as applicable). For the avoidance of doubt, the licenses granted by Sanofi to MyoKardia under this Agreement do not include any rights for MyoKardia to develop, make, have made, sell, offer for sale or otherwise commercialize any proprietary compound of Sanofi that is not a Compound, as a single agent product or as part of any Combination Product. In addition, the grant of the foregoing licenses to MyoKardia shall not be construed to impose any obligation to disclose any Know-How other than as expressly set forth herein. MyoKardia shall not use any proprietary assay to the extent Controlled by Sanofi or its Affiliates that are identified as proprietary Sanofi assays in the Research Plan or applicable Development Plan and provided to MyoKardia by Sanofi hereunder for any purpose other than to conduct the activities Net Sales allocated to MyoKardia under the Research Plan or POC Development Plan as specifically set forth therein, but in no event shall MyoKardia be precluded from using publicly available assays for any purposesuch Sanofi Proprietary Device Component .
Appears in 1 contract
Samples: License and Collaboration Agreement (MyoKardia Inc)