Right to Subcontract. Subject to the terms of this Agreement, Licensee will have the right to engage Subcontractors, without requiring Licensor’s prior written consent, for the sole purpose of performing Licensee’s obligations with respect to the Manufacturing, Development, performance of Medical Affairs activities with respect to, or Commercialization of the Licensed Products in the Territory in accordance with the terms of this Agreement. Licensee will require that each Subcontractor comply with the terms of this Agreement that are applicable to such Subcontractor, including containing the record keeping and audit requirements set forth under Section 4.4 (Clinical Trial Audit Rights) and Section 4.5 (Development Records), a Right of Reference to Licensee and Licensor under any Regulatory Approvals and Regulatory Submissions Controlled by such Subcontractor or its Affiliate with respect to any Licensed Product, consistent in scope with the Right of Reference granted to each Party under Section 5.5 (Right of Reference), confidentiality and non-use provisions that are at least as stringent as those set forth in Article 11 (Confidentiality; Publication), the anti-corruption, export restrictions, privacy and data protection covenants set forth in Section 12.4 (Licensee Covenants), 12.5 (Export Controls) and 12.8 (Compliance), and the intellectual property provisions set forth in Article 14 (Intellectual Property) including a license or present assignment(s) back to Licensee of all Licensee Collaboration Know- How and Licensee Collaboration Patent Rights conceived, discovered, developed, generated, invented, or otherwise made by or on behalf of the Subcontractor, as applicable, such that Licensee can grant Licensor the license set forth in Section 2.4 (License Grant to Licensor) with respect to such Licensee Collaboration Know-How and Licensee Collaboration Patent Rights and assignment of Product Inventions set forth in Section 14.1.2(b) (Ownership of Arising Intellectual Property). Licensee will conduct appropriate risk-based due diligence to assess the capabilities, compliance, and reputation of Subcontractors that it engages. Licensee will not engage any Subcontractor that is Debarred/Excluded.
Appears in 1 contract
Right to Subcontract. Subject CStone will not propose the engagement of any Subcontractor that is Debarred/Excluded. Prior to CStone’s engagement of the first Subcontractor, CStone will provide to the JSC to review, discuss, and determine whether to approve as Preapproved Subcontractors a list of Subcontractors that CStone may engage to perform its obligations and exercise its rights under this Agreement. In addition, during the term, CStone may propose additional Subcontractors to be approved by the JSC as Preapproved Subcontractors and following the approval by the JSC of any such additional Subcontractors, such Subcontractors will be Preapproved Subcontractors. CStone may engage any such Preapproved Subcontractor to perform CStone’s obligations and exercise of CStone’s rights under this Agreement. In addition, if CStone wishes to engage a Subcontractor that is not a Preapproved Subcontractor to perform its obligations or exercise its rights under this Agreement related to the (a) Development or Manufacture of a Collaboration Product, or (b) prior to [***] for a Blueprint Product in a region in the Territory, the Commercialization of such Blueprint Product (or the Combination Regimen of which such Blueprint Product is a part) in such region, then in each case ((a) and (b)), CStone will provide written notice to Blueprint at least [***] before engaging any such Subcontractor identifying CStone’s intention to engage such Subcontractor, the purpose of engaging such Subcontractor, and the identity of such Subcontractor. Within [***] after the receipt of such written notice, Blueprint may provide written notice of its veto of CStone’s engagement of such proposed Subcontractor and in such case, CStone will not engage such Subcontractor to perform its obligations or exercise its rights under this Agreement. If Blueprint does not provide written notice to CStone of Blueprint’s veto of CStone’s engagement of a particular proposed Subcontractor within [***] after Blueprint’s receipt of such notice, then CStone may engage such proposed Subcontractor to perform its obligations or exercise its rights under this Agreement (subject to the terms set forth herein). In any event, any agreement pursuant to which CStone engages any Subcontractor must be consistent with the terms of this Agreement, Licensee will have the right to engage Subcontractors, without requiring Licensor’s prior written consent, for the sole purpose of performing Licensee’s obligations with respect to the Manufacturing, Development, performance of Medical Affairs activities with respect to, or Commercialization of the Licensed Products in the Territory in accordance with the terms of this Agreement. Licensee will require that each Subcontractor comply with the terms of this Agreement that are applicable to such Subcontractor, including containing the record keeping and audit requirements set forth under Section 4.4 (Clinical Trial Audit Rights) and Section 4.5 (Development Records), a Right obligations of Reference to Licensee and Licensor under any Regulatory Approvals and Regulatory Submissions Controlled by such Subcontractor or its Affiliate with respect to any Licensed Product, consistent in scope with the Right of Reference granted to each Party under Section 5.5 (Right of Reference), confidentiality and non-use provisions that are at least as stringent as those set forth in Article 11 (Confidentiality; Publication), the anti-corruption, export restrictions, privacy and data protection covenants set forth in Section 12.4 (Licensee Covenants), 12.5 (Export Controls) and 12.8 (Compliance), and terms that are consistent with the intellectual property provisions set forth in Article 14 (Intellectual Property) including a license or present assignment(s) back to Licensee of all Licensee Collaboration Know- How and Licensee Collaboration Patent Rights conceived, discovered, developed, generated, invented, or otherwise made by or on behalf ). Without limiting the generality of the Subcontractorforegoing, as applicable, such that Licensee can grant Licensor the license set forth in Section 2.4 (License Grant each agreement pursuant to Licensor) with respect which CStone engages a Subcontractor to such Licensee Exploit Collaboration Know-How and Licensee Collaboration Patent Rights and assignment of Product Inventions set forth in Section 14.1.2(b) (Ownership of Arising Intellectual Property). Licensee will conduct appropriate risk-based due diligence to assess the capabilities, compliance, and reputation of Subcontractors that it engages. Licensee will not engage any Subcontractor that is Debarred/ExcludedProducts hereunder must include [***].
Appears in 1 contract
Sources: License and Collaboration Agreement (Blueprint Medicines Corp)
Right to Subcontract. Subject ▇▇▇ will not propose the engagement of any Subcontractor that is Debarred/Excluded. Zai may engage (a) Subcontractors solely to perform ▇▇▇’s Development activities with respect to Licensed Products under this Agreement on ▇▇▇’s behalf (each a “Development Subcontractor”) or (b) Third Party Distributors to distribute Licensed Products in the Territory on behalf of ▇▇▇, in either case, without Blueprint’s prior written consent, but subject to the requirements set forth in the first, the second to last, and the last sentence of this Section 2.2.3 (Right to Subcontract), Section 2.2.4 (Notices of Sublicensing and Subcontractors), Section 2.2.5 (Zai Audits of Sublicensees and Subcontractors), and Section 2.2.6 (Responsibility for Sublicensees and Subcontractors). Prior to ▇▇▇’s engagement of the first Subcontractor (other than a Development Subcontractor or Third Party Distributor), ▇▇▇ will provide to the JSC to review, discuss, and determine whether to approve as Preapproved Subcontractors a list of Subcontractors that Zai may engage to perform its obligations and exercise its rights under this Agreement. In addition, during the term, ▇▇▇ may propose additional Subcontractors to be approved by the JSC as Preapproved Subcontractors and following the approval by the JSC of any such additional Subcontractors, such Subcontractors will be Preapproved Subcontractors. Zai may engage any such Preapproved Subcontractor to perform Zai’s obligations and exercise of ▇▇▇’s rights under this Agreement. In addition, if ▇▇▇ wishes to engage a Subcontractor (other than a Development Subcontractor or Third Party Distributor) that is not a Preapproved Subcontractor to perform its obligations or exercise its rights under this Agreement related to the (i) Manufacture of a Licensed Product following completion of the Manufacturing Technology Transfer, or (ii) the Commercialization of such Licensed Product in a region in the Territory, then, in each case ((i) and (ii)), Zai will provide written notice to Blueprint at least [****] before engaging any such Subcontractor identifying ▇▇▇’s intention to engage such Subcontractor, the purpose of engaging such Subcontractor, and the identity of such Subcontractor. Within [****] after the receipt of such written notice, Blueprint may provide written notice of its veto of ▇▇▇’s engagement of such proposed Subcontractor and in such case, ▇▇▇ will not engage such Subcontractor to perform its obligations or exercise its rights under this Agreement, provided that Blueprint will not unreasonably veto such engagement. If Blueprint does not provide written notice to Zai of Blueprint’s veto of ▇▇▇’s engagement of a particular proposed Subcontractor within [****] after Blueprint’s receipt of such notice, then Zai may engage such proposed Subcontractor to perform its obligations or exercise its rights under this Agreement (subject to the terms set forth herein). Any agreement pursuant to which ▇▇▇ engages any Subcontractor (including any Development Subcontractor or Third Party Distributor) must be consistent with the terms of this Agreement, Licensee will have the right to engage Subcontractors, without requiring Licensor’s prior written consent, for the sole purpose of performing Licensee’s obligations with respect to the Manufacturing, Development, performance of Medical Affairs activities with respect to, or Commercialization of the Licensed Products in the Territory in accordance with the terms of this Agreement. Licensee will require that each Subcontractor comply with the terms of this Agreement that are applicable to such Subcontractor, including containing the record keeping and audit requirements set forth under Section 4.4 (Clinical Trial Audit Rights) and Section 4.5 (Development Records), a Right obligations of Reference to Licensee and Licensor under any Regulatory Approvals and Regulatory Submissions Controlled by such Subcontractor or its Affiliate with respect to any Licensed Product, consistent in scope with the Right of Reference granted to each Party under Section 5.5 (Right of Reference), confidentiality and non-use provisions that are at least as stringent as those set forth in Article 11 (Confidentiality; Publication), the anti-corruption, export restrictions, privacy and data protection covenants set forth in Section 12.4 (Licensee Covenants), 12.5 (Export Controls) and 12.8 (Compliance), and terms that are consistent with the intellectual property provisions set forth in Article 14 (Intellectual Property) including a license or present assignment(s) back to Licensee of all Licensee Collaboration Know- How and Licensee Collaboration Patent Rights conceived, discovered, developed, generated, invented, or otherwise made by or on behalf ). Without limiting the generality of the Subcontractorforegoing, as applicableunless otherwise agreed by the Parties, such that Licensee can grant Licensor the license set forth in Section 2.4 each agreement pursuant to which ▇▇▇ engages a Subcontractor (License Grant including any Development Subcontractor or Third Party Distributor) to Licensor) with respect to such Licensee Collaboration Know-How and Licensee Collaboration Patent Rights and assignment of Product Inventions set forth in Section 14.1.2(b) (Ownership of Arising Intellectual Property). Licensee will conduct appropriate risk-based due diligence to assess the capabilities, compliance, and reputation of Subcontractors that it engages. Licensee will not engage any Subcontractor that is Debarred/ExcludedExploit Licensed Products hereunder must include [****].
Appears in 1 contract
Right to Subcontract. Subject to the terms of this AgreementSection 8.4 (Right to Subcontract), Licensee will each Party shall have the right to engage Third Party contractors working on its behalf (the “Permitted Subcontractors, without requiring Licensor’s ”) to perform certain activities under or in connection with this Agreement that such Party is responsible for; provided that: (a) any use of Permitted Subcontractors by Septerna is subject to the prior written consentapproval of Novo Nordisk; and (b) under no circumstances can such Permitted Subcontractor be debarred or disqualified by a Regulatory Authority, and if any such Permitted Subcontractor is debarred or disqualified by a Regulatory Authority after engagement by Septerna or its Affiliates, Septerna shall promptly terminate such engagement with such Permitted Subcontractors after becoming aware of such debarment or disqualification. Any Permitted Subcontractor to be engaged by a Party to perform certain activities under any R&D Plan shall meet the qualifications typically required by such Party for the sole purpose performance of performing Licensee’s obligations activities similar in scope and complexity to the subcontracted activities; provided, further, that the Third Party contractors set forth on Schedule 8.4 shall be deemed approved by Novo Nordisk for the activities set forth on such schedule. Furthermore, in addition to the foregoing, each Party shall be responsible for ensuring that, prior to engaging any Permitted Subcontractor to perform any activities under any R&D Plan, such Permitted Subcontractor is subject to written agreements containing terms and conditions: (i) consistent with, and which provides a substantially similar degree of protection as, the relevant terms and conditions of this Agreement with respect to protecting the Manufacturingrights of the Parties under this Agreement, Development, performance including imposing obligations of Medical Affairs activities confidentiality on each such Permitted Subcontractor that are no less onerous than those set forth in Section 13.1 (Duty of Confidence); (ii) that vests ownership in such Party of any and all intellectual property rights (including Know-How) covering inventions developed by such Permitted Subcontractor in the course of performing such subcontracted work (other than any background or platform intellectual property rights that are not specific to any Licensed Compound or Licensed Product and are customarily retained by a subcontractor; provided that suitable licenses are granted to such Party with respect to, thereto); (iii) that does not under any circumstance impose any payment obligations or Commercialization of liability on the Licensed Products in the Territory in accordance with the terms of this Agreement. Licensee will require other Party; and (iv) that each Subcontractor comply is otherwise consistent with the terms of this Agreement that are applicable to such Subcontractorsubcontracted work. Septerna shall use [***] to obtain the right for Novo Nordisk, including containing the record keeping once annually and at Novo Nordisk’s sole cost and expense, to audit requirements set forth under Section 4.4 (Clinical Trial Audit Rights) and Section 4.5 (Development Records), a Right Permitted Subcontractors of Reference to Licensee and Licensor under any Regulatory Approvals and Regulatory Submissions Controlled by such Subcontractor or its Affiliate Septerna with respect to the activities performed by such Permitted Subcontractors under or in connection with this Agreement; provided that if, despite its use of [***], Septerna is unable to obtain such right for Novo Nordisk, Septerna shall obtain the right to, and upon Novo Nordisk’s request shall, audit such Permitted Subcontractor directly and disclose any Licensed Product, consistent in scope audit results to Novo Nordisk. Each Party shall remain directly responsible for all of its obligations under this Agreement that have been subcontracted or sublicensed to any Permitted Subcontractor. Each Party shall remain directly responsible for its subcontractors’ compliance with the Right of Reference granted to each Party under Section 5.5 (Right of Reference), confidentiality and non-use provisions that are at least as stringent as those set forth in Article 11 (Confidentiality; Publication), the anti-corruption, export restrictions, privacy and data protection covenants set forth in Section 12.4 (Licensee Covenants), 12.5 (Export Controls) and 12.8 (Compliance)this Agreement, and the intellectual property provisions set forth in Article 14 (Intellectual Property) including Party engaging such subcontractor shall be responsible and liable for any act or omission of such subcontractor that constitutes a license or present assignment(s) back breach of this Agreement to Licensee of all Licensee Collaboration Know- How and Licensee Collaboration Patent Rights conceived, discovered, developed, generated, invented, or otherwise made the same extent as though such breach were caused by or on behalf of the Subcontractor, as applicable, such that Licensee can grant Licensor the license set forth in Section 2.4 (License Grant to Licensor) with respect to Party engaging such Licensee Collaboration Know-How and Licensee Collaboration Patent Rights and assignment of Product Inventions set forth in Section 14.1.2(b) (Ownership of Arising Intellectual Property). Licensee will conduct appropriate risk-based due diligence to assess the capabilities, compliance, and reputation of Subcontractors that it engages. Licensee will not engage any Subcontractor that is Debarred/Excludedsubcontractor.
Appears in 1 contract
Sources: Collaboration and License Agreement (Septerna, Inc.)
Right to Subcontract. Subject to the terms of this AgreementSection 4.8 and Section 5.1.2, Licensee will each Party shall have the right to engage permitted Third Party contractors working on its behalf (the “Permitted Subcontractors”) to perform such portions of its Research and Development obligations under this Agreement that it customarily engages for its other similar research and Development activities, without requiring Licensor’s except that: (a) any use of Permitted Subcontractors by Dicerna is subject to the prior written consentapproval of Novo, except for the sole purpose contract manufacturers listed on Exhibit I; and (b) under no circumstance can such Permitted Subcontractor be debarred or disqualified by a regulatory authority. Any Permitted Subcontractor to be engaged by a Party to perform its obligations under this Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activities. Furthermore, notwithstanding the foregoing, each Party shall be responsible for ensuring that, prior to engaging any Permitted Subcontractor that such Permitted Subcontractor is subject to written agreements containing terms and conditions: (i) consistent with and which provides a substantially similar degree of protection as the relevant terms and conditions of this Agreement protecting the rights of the Parties under this Agreement including imposing obligations of confidentiality on each such Permitted Subcontractor; (ii) that vests ownership in such Party of any and all Inventions developed by such Permitted Subcontractor in the course of performing Licensee’s such subcontracted work; (iii) that does not under any circumstance impose any payment obligations with respect to or liability on the Manufacturingother Party, Development, performance of Medical Affairs activities with respect to, or Commercialization of the Licensed Products in the Territory in accordance and (iv) that is otherwise consistent with the terms of this Agreement. Licensee will require that each Subcontractor comply Dicerna shall obtain the right for Novo to once annually and at its own expense to audit Permitted Subcontractors of Dicerna in accordance with the terms Section 4.6.4. Each Party shall remain directly responsible for all of its obligations under this Agreement that are applicable to such Subcontractor, including containing the record keeping and audit requirements set forth under Section 4.4 (Clinical Trial Audit Rights) and Section 4.5 (Development Records), a Right of Reference to Licensee and Licensor under any Regulatory Approvals and Regulatory Submissions Controlled by such Subcontractor have been subcontracted or its Affiliate with respect sublicensed to any Licensed Product, consistent in scope with the Right of Reference granted to each Party under Section 5.5 (Right of Reference), confidentiality and non-use provisions that are at least as stringent as those set forth in Article 11 (Confidentiality; Publication), the anti-corruption, export restrictions, privacy and data protection covenants set forth in Section 12.4 (Licensee Covenants), 12.5 (Export Controls) and 12.8 (Compliance), and the intellectual property provisions set forth in Article 14 (Intellectual Property) including a license or present assignment(s) back to Licensee of all Licensee Collaboration Know- How and Licensee Collaboration Patent Rights conceived, discovered, developed, generated, invented, or otherwise made by or on behalf of the Permitted Subcontractor, as applicable, such that Licensee can grant Licensor the license set forth in Section 2.4 (License Grant to Licensor) with respect to such Licensee Collaboration Know-How and Licensee Collaboration Patent Rights and assignment of Product Inventions set forth in Section 14.1.2(b) (Ownership of Arising Intellectual Property). Licensee will conduct appropriate risk-based due diligence to assess the capabilities, compliance, and reputation of Subcontractors that it engages. Licensee will not engage any Subcontractor that is Debarred/Excluded.
Appears in 1 contract
Sources: Collaboration and License Agreement (Dicerna Pharmaceuticals Inc)
Right to Subcontract. Subject to the terms of this Agreement, Licensee will have the right to engage Subcontractors, without requiring Licensor’s prior written consent, Subcontractors for the sole purpose of performing Licensee’s obligations with respect to the Manufacturing, Development, performance of Medical Affairs activities with respect to, or Commercialization of the Licensed Products in the Territory Japan in accordance with the terms of this Agreement. Licensee will require that each Subcontractor comply with the terms of this Agreement that are applicable to such Subcontractor, Subcontractor (including containing the record keeping and audit requirements set forth under Section 4.4 (Clinical Trial Audit Rights) and Section 4.5 (Development Records), a Right right of Reference reference to Licensee and Licensor under any Regulatory Approvals and Regulatory Submissions Controlled by such Subcontractor or its Affiliate with respect to any Licensed Product, consistent in scope with the Right right of Reference reference granted to each Party under Section 5.5 (Right of Reference), confidentiality and non-use provisions that are at least as stringent as those set forth in Article 11 (Confidentiality; Publication), the anti-corruption, export restrictions, privacy and data protection covenants set forth in Section 12.4 (Licensee CovenantsCovenants of Licensee), 12.5 12.6 (Export Controls) and 12.8 (Compliance), and the intellectual property provisions set forth in Article 14 (Intellectual Property) including a license or present assignment(s) back to Licensee of all Licensee Collaboration Know- Know-How and Licensee Collaboration Patent Rights conceived, discovered, developed, generated, invented, or otherwise made by or on behalf of the Subcontractor, as applicable, such that Licensee can grant Licensor the license set forth in Section 2.4 2.3 (License Grant to Licensor) with respect to such Licensee Collaboration Know-How and Licensee Collaboration Patent Rights and assignment of Product Inventions set forth in Section 14.1.2(b) (Ownership of Arising Intellectual PropertyRights). Licensee will conduct appropriate risk-based due diligence to assess the capabilities, compliance, and reputation of Subcontractors that it engages. Licensee will not engage or propose the engagement of any Subcontractor that is Debarred/Excluded.
Appears in 1 contract