Exclusivity Covenant. Subject to Alnylam Third Party Obligations and Section 15.15: (a) During the Research Term and for a period of [**] thereafter, neither Party nor such Party’s Affiliates shall, except pursuant to this Agreement, directly or indirectly, conduct Development of, Manufacture or Commercialize, anywhere in the Territory, any Competitive Product, or grant any rights to a Third Party to do any of the foregoing. (b) After the Research Term, during the period of Development prior to the first Regulatory Approval in the Territory of a Licensed Product under the Program for the given Program Target(s) to which such Licensed Product is directed, neither Party nor such Party’s Affiliates shall, except pursuant to this Agreement, directly or indirectly, conduct Development of, Manufacture or Commercialize, anywhere in the Territory, any Competitive Product directed to such given Program Target(s), or grant any rights to a Third Party to do any of the foregoing. Without limiting the foregoing exclusivity with respect to any Program Target(s) that remain in the Program, if either Party exercises its Opt-Out Right during such period of Development prior to the first Regulatory Approval for any Opt-Out Product(s) in the Territory and the other Party assumes the unilateral Development and Commercialization of such Opt-Out Product(s), the opting-out Party and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, conduct Development in a Phase II Study of, or Commercialize, anywhere in the Territory, any Competitive Product directed against the same Program Target(s) as the Opt-Out Product(s), or grant any rights to a Third Party to do any of the foregoing, for a period of [**] from and after the effective date of such opt-out. (c) For a period of [**] after the first Regulatory Approval in the Territory for a Licensed Product under the Program for the given Program Target(s) to which such Licensed Product is directed, neither Party nor such Party’s Affiliates shall, except pursuant to this Agreement, directly or indirectly, conduct Development in a Phase III Study of, or Commercialize, anywhere in the Territory, any Competitive Product directed to such given Program Target(s), or grant any rights to a Third Party to do any of the foregoing. Without limiting the foregoing exclusivity with respect to any Program Target(s) that remain in the Program, if either Party exercises its Opt-Out Right during such period of [**] after the first Regulatory Approval for any Opt-Out Product(s) in the Territory and the other Party assumes the unilateral Development and Commercialization of such Opt-Out Product(s), the opting-out Party and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, conduct Development in a Phase III Study of, or Commercialize, anywhere in the Territory, any Competitive Product directed against the same Program Target(s) as the Opt-Out Product(s), or grant any rights to a Third Party to do any of the foregoing, for a period of [**] from and after the effective date of such opt-out. (d) For purposes of clarity, nothing in clause (a), (b) or (c) above is intended to prohibit the Party exercising the Opt-Out Right with respect to any Opt-Out Product(s) from continuing to Develop, Manufacture and Commercialize any Licensed Product(s) other than the Opt-Out Product(s), or from performing its Manufacturing obligations hereunder with respect to any Opt-Out Product(s), pursuant to, and in accordance with the terms of, this Agreement.
Appears in 1 contract
Sources: Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Exclusivity Covenant. Subject to Alnylam Third Party Obligations and Section 15.15:
(a) During the Research Term and for a period of [**] thereafter, neither Party nor such Party’s Affiliates shall, except pursuant to this Agreement, directly or indirectly, conduct Development of, Manufacture or Commercialize, anywhere in the Territory, any Competitive Product, or grant any rights to a Third Party to do any of the foregoing. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
(b) After the Research Term, during the period of Development prior to the first Regulatory Approval in the Territory of a Licensed Product under the Program for the given Program Target(s) to which such Licensed Product is directed, neither Party nor such Party’s Affiliates shall, except pursuant to this Agreement, directly or indirectly, conduct Development of, Manufacture or Commercialize, anywhere in the Territory, any Competitive Product directed to such given Program Target(s), or grant any rights to a Third Party to do any of the foregoing. Without limiting the foregoing exclusivity with respect to any Program Target(s) that remain in the Program, if either Party exercises its Opt-Out Right during such period of Development prior to the first Regulatory Approval for any Opt-Out Product(s) in the Territory and the other Party assumes the unilateral Development and Commercialization of such Opt-Out Product(s), the opting-out Party and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, conduct Development in a Phase II Study of, or Commercialize, anywhere in the Territory, any Competitive Product directed against the same Program Target(s) as the Opt-Out Product(s), or grant any rights to a Third Party to do any of the foregoing, for a period of [**] from and after the effective date of such opt-out.
(c) For a period of [**] after the first Regulatory Approval in the Territory for a Licensed Product under the Program for the given Program Target(s) to which such Licensed Product is directed, neither Party nor such Party’s Affiliates shall, except pursuant to this Agreement, directly or indirectly, conduct Development in a Phase III Study of, or Commercialize, anywhere in the Territory, any Competitive Product directed to such given Program Target(s), or grant any rights to a Third Party to do any of the foregoing. Without limiting the foregoing exclusivity with respect to any Program Target(s) that remain in the Program, if either Party exercises its Opt-Out Right during such period of [**] after the first Regulatory Approval for any Opt-Out Product(s) in the Territory and the other Party assumes the unilateral Development and Commercialization of such Opt-Out Product(s), the opting-out Party and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, conduct Development in a Phase III Study of, or Commercialize, anywhere in the Territory, any Competitive Product directed against the same Program Target(s) as the Opt-Out Product(s), or grant any rights to a Third Party to do any of the foregoing, for a period of [**] from and after the effective date of such opt-out.
(d) For purposes of clarity, nothing in clause (a), (b) or (c) above is intended to prohibit the Party exercising the Opt-Out Right with respect to any Opt-Out Product(s) from continuing to Develop, Manufacture and Commercialize any Licensed Product(s) other than the Opt-Out Product(s), or from performing its Manufacturing obligations hereunder with respect to any Opt-Out Product(s), pursuant to, and in accordance with the terms of, this Agreement. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Appears in 1 contract
Exclusivity Covenant. Subject Except as provided in Section 2.5 and in Sections 2.8.3 and 2.8.4 below and subject to Alnylam Third Party Obligations and Section 15.15:
(a) During the Research Term and for a period of [**] thereafter, neither Party nor such Party’s Affiliates shall, except pursuant to this Agreement, directly or indirectly, conduct Development of, Manufacture or Commercialize, anywhere in the Territory, any Competitive Product, or grant any rights to a Third Party to do any of the foregoing.
(b) After the Research Term2.8.5 below, during the period of Development prior time that commences on the Agreement Date and until the earlier of:
(i) the date that is *** ***, or
(ii) such date as it is determined under Section 4.4.1 that BMS is not using Diligent Efforts to the first Regulatory Approval in the Territory of a Licensed Product under the Program for the given Program Target(s) to which such Licensed Product is directeddevelop or market at least one Collaboration Compound, neither Party nor such Party’s Affiliates shall, except pursuant to this Agreement, directly or indirectly, conduct Development of, Manufacture or Commercialize, anywhere in the Territory, any Competitive Product directed to such given Program Target(s), or grant any rights to a Third Party to do any of the foregoing. Without limiting the foregoing exclusivity with respect to any Program Target(s) that remain in the Program, if either Party exercises its Opt-Out Right during such period of Development prior to the first Regulatory Approval for any Opt-Out Product(s) in the Territory and the other Party assumes the unilateral Development and Commercialization of such Opt-Out Product(s), the opting-out each Party and its Affiliates shall not, except not (and such Party shall cause its Affiliates not to): *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
2.8.1.1 conduct pre-clinical or clinical research testing, other than the Research Program, whether on its own or as part of a collaborative alliance with (or contracted services to) any Third Party, a goal of which is to discover or develop any small molecule compound within the Field; PROVIDED, that the foregoing shall not apply to Pre-Clinical and Clinical Development of any Collaboration Lead Compound or Product by BMS in furtherance of this Agreement, directly or indirectly, conduct Development to the exercise by BMS of the rights granted to it under Article 5 following the Research Term in a Phase II Study offurtherance of this Agreement, or Commercialize, anywhere to the exercise of any sublicense rights granted to BMS under Article 5 hereof (and any collaboration by BMS with any such sublicensee in connection with the Territory, any Competitive Product directed against the same Program Target(s) as the Opt-Out Product(s), or grant of such rights)in furtherance of this Agreement; and
2.8.1.2 grant any rights under any Background Technology, Patent Rights, Know-How, or Collaboration Technology Controlled by such Party to a any Third Party or to do any of the foregoing, for a period of [**] from and after the effective date Affiliates of such opt-out.
(c) For Third Party a period purpose of [**] after which is to conduct research, development, use, manufacture, sale or commercialization of any small molecule compound within the first Regulatory Approval in Field; PROVIDED, that the Territory for a Licensed Product foregoing shall not apply to the grant by BMS of such rights under the Program foregoing as BMS deems appropriate in connection with the grant of a sublicense pursuant to Section 5.1.4 hereof; and
2.8.1.3 grant any rights under any Background Technology, Patent Rights, Know-How or Collaboration Technology Controlled by such Party to any Third Party or to any Affiliates of such Third Party for primary screening against the Designated Target or for the given Program Target(s) purpose of identifying any small molecule compound for use within the Field; PROVIDED, that the foregoing shall not apply to which the grant by BMS of such Licensed Product is directed, neither Party nor such Party’s Affiliates shall, except rights under the foregoing as BMS deems appropriate in connection with the grant of a sublicense pursuant to Section 5.1.4 hereof; and
2.8.1.4 commercialize, whether on its own or as part of a collaborative alliance with (or contracted services to) any Third Party, any small molecule compound within the Field; PROVIDED, that the foregoing shall not apply to Pre-Clinical and Clinical Development of any Collaboration Lead Compound or Product by BMS in furtherance of this Agreement, directly or indirectly, conduct Development in a Phase III Study ofto the exercise by BMS of the rights granted to it under Article 5 following the Research Term, or Commercialize, anywhere to the exercise of any sublicense rights granted to BMS under Article 5 hereof (and any collaboration by BMS with any such sublicensee in connection with the Territory, any Competitive Product directed to such given Program Target(s), or grant any rights to a Third Party to do any of the foregoing. Without limiting the foregoing exclusivity with respect to any Program Target(s) that remain in the Program, if either Party exercises its Opt-Out Right during such period of [**] after the first Regulatory Approval for any Opt-Out Product(s) in the Territory and the other Party assumes the unilateral Development and Commercialization of such Opt-Out Product(srights), the opting-out Party and its Affiliates shall not, except pursuant to this Agreement, directly or indirectly, conduct Development in a Phase III Study of, or Commercialize, anywhere in the Territory, any Competitive Product directed against the same Program Target(s) as the Opt-Out Product(s), or grant any rights to a Third Party to do any of the foregoing, for a period of [**] from and after the effective date of such opt-out.
(d) For purposes of clarity, nothing in clause (a), (b) or (c) above is intended to prohibit the Party exercising the Opt-Out Right with respect to any Opt-Out Product(s) from continuing to Develop, Manufacture and Commercialize any Licensed Product(s) other than the Opt-Out Product(s), or from performing its Manufacturing obligations hereunder with respect to any Opt-Out Product(s), pursuant to, and in accordance with the terms of, this Agreement.
Appears in 1 contract
Sources: Research, Development and License Agreement (Ligand Pharmaceuticals Inc)