Common use of Licensee Covenants Clause in Contracts

Licensee Covenants. Licensee covenants to TESARO that: (a) it will conduct, and will use reasonable efforts to cause its contractors to conduct, all preclinical and clinical studies for the Product and the manufacturing of the Product, in accordance in all material respects with (i) all applicable Law in the Licensed Territory, (ii) the published standards of any applicable Regulatory Authorities in the Licensed Territory, and (iii) the scientific standards applicable to the conduct of such studies and activities in the Licensed Territory, including current good laboratory practice, current good clinical practice and current good manufacturing practice; (b) it will prepare, maintain and retain all Regulatory Materials in the Licensed Territory pursuant to and in accordance in all material respects with all applicable Law and will not make any materially false or misleading statement to a Regulatory Authority in connection with such Regulatory Materials; (c) it will not knowingly employ any personnel or knowingly use a contractor or consultant that has been debarred or subject to a similar sanction by any Regulatory Authority or that is the subject of any investigation or proceeding with respect thereto; (d) during the Term and for a period of [***] thereafter, Licensee shall not, and shall cause its Affiliates not to, directly or indirectly, develop, manufacture, market, promote, import, export, or sell, or assist any Third Party, directly or indirectly, to develop, manufacture, market, promote, import, export, or sell anywhere in the world, any generic version of the Product without the prior written consent of TESARO (collectively, “Competing Activities”); provided, that if Licensee is merged or consolidated with a Third Party or enters into any transaction with a Third Party that, in either case, is at the time of entering into the transaction, engaged in Competing Activities and, as a result of such transaction becomes an Affiliate of Licensee (a “Subject Transaction”), nothing in this section shall restrict such Third Party or its Affiliates (“Post-Execution Affiliate”) from continuing to pursue or engage in the research, development, manufacture or commercialization of any product in connection with programs of such Post-Execution Affiliate existing prior to the effective time of such Subject Transaction, provided that: (1) Licensee shall provide TESARO with written notice of any such Subject Transaction within [***] following the earlier of the first public announcement of the execution of any agreement with respect to such Subject Transaction and the closing date of such Subject Transaction; and (2) such Post-Execution Affiliate’s Competing Activities shall be kept separate from the activities of Licensee; (e) Licensee shall seek TESARO’s input in connection with its determination of the following matters: (i) the last to expire Valid Claim that prevents the entry of a Generic Product in Japan; and (ii) the expiration of the Drug Re-Examination Period for the primary indication of the Product in Japan (the last of (i) and (ii) to occur, the “Expiration Event”). [***]; and (f) During the Term, Licensee shall not amend, waive or otherwise modify (or consent to any of the foregoing) [***] in any manner that would reasonably be expected to conflict with the terms of this Agreement, including the consideration payable to TESARO hereunder for the rights and licenses granted to Licensee, or the segregation of TESARO’s Confidential Information, including Licensed Know-How and any other information related to the Licensed Compound or Product that is not part of the public domain, without TESARO’s prior written consent.

Licensee Covenants. In addition to any covenants made by Licensee elsewhere in this Agreement, Licensee hereby covenants to TESARO thatInventiva as follows: (a) it Licensee will conductnot knowingly, during the Term, employ or use the services of any person who is debarred or disqualified in connection with activities relating to the Licensed Compound or Licensed Products; and in the event that Licensee becomes aware of the debarment or disqualification or threatened debarment or disqualification of any person providing services to Licensee with respect to any activities relating to the Licensed Compound or Licensed Products, Licensee will use reasonable efforts immediately notify Inventiva in writing and Licensee will cease employing, contracting with, or retaining any such person to cause perform any services relating to the Licensed Compound or Licensed Products; Licensee will not, in connection with the performance of its contractors obligations under this Agreement (nor under any other agreement with Inventiva or Inventiva’s Affiliate(s)), directly or indirectly through Third Parties, offer or provide any corrupt payment, bribe or other illegal benefit to conductany public official, all preclinical and clinical studies public institution or entity or healthcare professional for the Product and the manufacturing purpose of the Product, in accordance in all material respects with obtaining or retaining any business opportunity or directing any business to any person (i) all applicable Law in the Licensed Territory, (ii) the published standards of any applicable Regulatory Authorities in the Licensed Territory, and (iii) the scientific standards applicable to the conduct of such studies and activities in the Licensed Territory, including current good laboratory practice, current good clinical practice and current good manufacturing practiceLicensee); (b) it will prepare, maintain Licensee has in place an anti-corruption and retain all Regulatory Materials in the Licensed Territory pursuant to anti-bribery policy and in accordance in all material respects with all applicable Law and will not make any materially false or misleading statement to a Regulatory Authority in connection with such Regulatory Materialsthe performance of its obligations under this Agreement, Licensee shall comply and shall take best efforts to cause its employees and its Affiliates’ employees to comply with Licensee’s policy; (c) it will not knowingly employ any personnel or knowingly use a contractor or consultant that has been debarred or subject to a similar sanction by any Regulatory Authority or that is the subject of any investigation or proceeding with respect thereto; (d) during the Term and for a period of [***] thereafter, Licensee shall notshall, and shall cause ensure that its Affiliates and Sublicensees directly engaged by Licensee and its and their respective employees and contractors will not to, directly or indirectly, develop, manufacture, market, promote, import, export, or sell, or assist cause Inventiva to be in violation of any Third Party, directly or indirectly, to develop, manufacture, market, promote, import, export, or sell anywhere Applicable Law in the worldLicensee Territory, including any generic version of the Product without the prior written consent of TESARO (collectivelyother applicable anti-corruption and anti-bribery laws, “Competing Activities”); provided, that if Licensee is merged or consolidated with a Third Party or enters into any transaction with a Third Party that, in either case, is at the time of entering into the transaction, engaged in Competing Activities and, as a result of such transaction becomes an Affiliate of Licensee (a “Subject Transaction”), nothing in this section shall restrict such Third Party or its Affiliates (“Post-Execution Affiliate”) from continuing to pursue or engage in the research, development, manufacture or commercialization of any product in connection with programs of such Post-Execution Affiliate existing prior to the effective time of such Subject Transaction, provided that: (1) Licensee shall provide TESARO with written notice of any such Subject Transaction within [***] following the earlier of the first public announcement of the execution of any agreement with respect to such Subject Transaction and the closing date of such Subject Transaction; and (2) such Post-Execution Affiliate’s Competing Activities shall be kept separate from the activities performance of Licensee; (e) Licensee shall seek TESARO’s input in connection with its determination of the following matters: (i) the last to expire Valid Claim that prevents the entry of a Generic Product in Japan; and (ii) the expiration of the Drug Re-Examination Period for the primary indication of the Product in Japan (the last of (i) and (ii) to occur, the “Expiration Event”). [***]; and (f) During the Term, Licensee shall not amend, waive or otherwise modify (or consent to any of the foregoing) [***] in any manner that would reasonably be expected to conflict with the terms of obligations under this Agreement, including the consideration payable to TESARO hereunder for the rights and licenses granted to Licensee, or the segregation of TESARO’s Confidential Information, including Licensed Know-How and any other information related to the Licensed Compound or Product that is not part of the public domain, without TESARO’s prior written consent.

Licensee Covenants. In addition to any covenants made by Licensee elsewhere in this Agreement, Licensee hereby covenants to TESARO thatLicensor as follows: (a) it neither Licensee nor any of its Affiliates or Related Parties will conductknowingly employ or use the services of any Person who is debarred or disqualified under United States law, including 21 U.S.C. §335a, or any foreign equivalent thereof, in connection with activities relating to any Compound or Product; and in the event that Licensee becomes aware of the debarment or disqualification or threatened debarment or disqualification of any Person providing services to Licensee or any of its Related Parties with respect to any activities relating to any Compound or Product, Licensee will use reasonable efforts to immediately notify Licensor in writing and Licensee will cease, or cause its contractors Related Party to conductcease (as applicable), all preclinical and clinical studies for the Product and the manufacturing of the employing, contracting with, or retaining any such Person to perform any services relating to any Compound or Product, in accordance in all material respects with (i) all applicable Law in the Licensed Territory, (ii) the published standards of any applicable Regulatory Authorities in the Licensed Territory, and (iii) the scientific standards applicable to the conduct of such studies and activities in the Licensed Territory, including current good laboratory practice, current good clinical practice and current good manufacturing practice; (b) neither Licensee nor any of its Related Parties will, in connection with the exercise of its rights or performance of its obligations under this Agreement or otherwise, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including Licensee and its Related Parties, nor will Licensee or any of its Related Parties directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other Person in connection with the exercise of Licensee’s rights or performance of Licensee’s obligations under this Agreement or otherwise; (c) neither Licensee nor any of its Related Parties (or any of their respective employees and contractors), in connection with the exercise of Licensee’s rights or performance of Licensee’s obligations under this Agreement or otherwise, shall be, or cause Licensor to be, in violation of the FCPA (including without limitation both anti-bribery provisions and books and records provisions), Export Control Laws or any other Applicable Laws; (d) Licensee shall immediately notify Licensor if it has any information or suspicion that there may be a violation by Licensee or any Related Party of the FCPA (including without limitation both anti-bribery provisions and books and records provisions), Export Control Laws or any other Applicable Laws in connection with the exercise of Licensee’s rights or performance of Licensee’s obligations under this Agreement or otherwise; and (e) all research and development and all manufacturing conducted by or on behalf of Licensee or any Related Party and relating to any Compounds or Products will prepare, maintain and retain all Regulatory Materials be conducted in the Licensed Territory pursuant to and in accordance compliance in all material respects with all applicable Law and will not make any materially false or misleading statement to a Regulatory Authority in connection with such Regulatory Materials; (c) it will not knowingly employ any personnel or knowingly use a contractor or consultant that has been debarred or subject to a similar sanction by any Regulatory Authority or that is the subject of any investigation or proceeding with respect thereto; (d) during the Term and for a period of [***] thereafter, Licensee shall not, and shall cause its Affiliates not to, directly or indirectly, develop, manufacture, market, promote, import, export, or sell, or assist any Third Party, directly or indirectly, to develop, manufacture, market, promote, import, export, or sell anywhere in the world, any generic version of the Product without the prior written consent of TESARO (collectively, “Competing Activities”); provided, that if Licensee is merged or consolidated with a Third Party or enters into any transaction with a Third Party that, in either case, is at the time of entering into the transaction, engaged in Competing Activities Applicable Laws and, as a result of such transaction becomes an Affiliate of Licensee (a “Subject Transaction”)applicable, nothing in this section shall restrict such Third Party or its Affiliates (“Post-Execution Affiliate”) from continuing to pursue or engage in the researchGLP, development, manufacture or commercialization of any product in connection with programs of such Post-Execution Affiliate existing prior to the effective time of such Subject Transaction, provided that: (1) Licensee shall provide TESARO with written notice of any such Subject Transaction within [***] following the earlier of the first public announcement of the execution of any agreement with respect to such Subject Transaction and the closing date of such Subject Transaction; and (2) such Post-Execution Affiliate’s Competing Activities shall be kept separate from the activities of Licensee; (e) Licensee shall seek TESARO’s input in connection with its determination of the following matters: (i) the last to expire Valid Claim that prevents the entry of a Generic Product in Japan; and (ii) the expiration of the Drug Re-Examination Period for the primary indication of the Product in Japan (the last of (i) and (ii) to occur, the “Expiration Event”). [***]; and (f) During the Term, Licensee shall not amend, waive or otherwise modify (or consent to any of the foregoing) [***] in any manner that would reasonably be expected to conflict with the terms of this Agreement, including the consideration payable to TESARO hereunder for the rights and licenses granted to Licensee, or the segregation of TESARO’s Confidential Information, including Licensed Know-How and any other information related to the Licensed Compound or Product that is not part of the public domain, without TESARO’s prior written consentGCP and/or GMP.

Licensee Covenants. Licensee In addition to any covenants made by LICENSEE elsewhere in this Agreement, LICENSEE hereby covenants to TESARO thatLICENSOR as follows: (a) it neither LICENSEE nor any of its Affiliates or Related Parties will conductknowingly employ or use the services of any Person who is debarred or disqualified under United States law, including 21 U.S.C. §335a, or any foreign equivalent thereof, in connection with activities relating to any Licensed Product; and in the event that LICENSEE becomes aware of the debarment or disqualification or threatened debarment or disqualification of any Person providing services to LICENSEE or any of its Related Parties with respect to any activities relating to any Licensed Product, LICENSEE will use reasonable efforts to immediately notify LICENSOR in writing and LICENSEE will cease, or cause its contractors Related Party to conductcease (as applicable), all preclinical and clinical studies for the Product and the manufacturing of the employing, contracting with, or retaining any such Person to perform any services relating to any Licensed Product, in accordance in all material respects with (i) all applicable Law in the Licensed Territory, (ii) the published standards of any applicable Regulatory Authorities in the Licensed Territory, and (iii) the scientific standards applicable to the conduct of such studies and activities in the Licensed Territory, including current good laboratory practice, current good clinical practice and current good manufacturing practice; (b) neither LICENSEE nor any of its Related Parties will, in connection with the exercise of its rights or performance of its obligations under this Agreement or otherwise, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including LICENSEE and its Related Parties, nor will LICENSEE or any of its Related Parties directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other Person in connection with the exercise of LICENSEE’s rights or performance of LICENSEE’s obligations under this Agreement or otherwise; (c) neither LICENSEE nor any of its Related Parties (or any of their respective employees and contractors), in connection with the exercise of LICENSEE’s rights or performance of LICENSEE’s obligations under this Agreement or otherwise, shall be, or cause LICENSOR to be, in violation of the FCPA (including without limitation both anti- bribery provisions and books and records provisions), Export Control Laws or any other Applicable Laws; (d) LICENSEE shall immediately notify LICENSOR if it has any information or suspicion that there may be a violation by LICENSEE or any Related Party of the FCPA (including without limitation both anti-bribery provisions and books and records provisions), Export Control Laws or any other Applicable Laws in connection with the exercise of LICENSEE’s rights or performance of LICENSEE’s obligations under this Agreement or otherwise;and (e) all research and Development and all manufacturing conducted by or on behalf of LICENSEE or any Related Party and relating to any Licensed Product(s) will prepare, maintain and retain all Regulatory Materials be conducted in the Licensed Territory pursuant to and in accordance compliance in all material respects with all applicable Law and will not make any materially false or misleading statement to a Regulatory Authority in connection with such Regulatory Materials; (c) it will not knowingly employ any personnel or knowingly use a contractor or consultant that has been debarred or subject to a similar sanction by any Regulatory Authority or that is the subject of any investigation or proceeding with respect thereto; (d) during the Term and for a period of [***] thereafter, Licensee shall not, and shall cause its Affiliates not to, directly or indirectly, develop, manufacture, market, promote, import, export, or sell, or assist any Third Party, directly or indirectly, to develop, manufacture, market, promote, import, export, or sell anywhere in the world, any generic version of the Product without the prior written consent of TESARO (collectively, “Competing Activities”); provided, that if Licensee is merged or consolidated with a Third Party or enters into any transaction with a Third Party that, in either case, is at the time of entering into the transaction, engaged in Competing Activities Applicable Laws and, as a result of such transaction becomes an Affiliate of Licensee (a “Subject Transaction”)applicable, nothing in this section shall restrict such Third Party or its Affiliates (“Post-Execution Affiliate”) from continuing to pursue or engage in the researchGLP, development, manufacture or commercialization of any product in connection with programs of such Post-Execution Affiliate existing prior to the effective time of such Subject Transaction, provided that: (1) Licensee shall provide TESARO with written notice of any such Subject Transaction within [***] following the earlier of the first public announcement of the execution of any agreement with respect to such Subject Transaction and the closing date of such Subject Transaction; and (2) such Post-Execution Affiliate’s Competing Activities shall be kept separate from the activities of Licensee; (e) Licensee shall seek TESARO’s input in connection with its determination of the following matters: (i) the last to expire Valid Claim that prevents the entry of a Generic Product in Japan; and (ii) the expiration of the Drug Re-Examination Period for the primary indication of the Product in Japan (the last of (i) and (ii) to occur, the “Expiration Event”). [***]; and (f) During the Term, Licensee shall not amend, waive or otherwise modify (or consent to any of the foregoing) [***] in any manner that would reasonably be expected to conflict with the terms of this Agreement, including the consideration payable to TESARO hereunder for the rights and licenses granted to Licensee, or the segregation of TESARO’s Confidential Information, including Licensed Know-How and any other information related to the Licensed Compound or Product that is not part of the public domain, without TESARO’s prior written consentGCP and/or GMP.

Licensee Covenants. In addition to any covenants made by Licensee elsewhere in this Agreement, Licensee hereby covenants to TESARO thatAllogene as follows: (a) it Licensee will conductnot knowingly, during the Term, employ or use the services of any person who is debarred or disqualified to perform any activities relating to the Compound or Products; and will use reasonable efforts to cause its contractors to conduct, all preclinical and clinical studies for in the Product and the manufacturing event that Licensee becomes aware of the Product, in accordance in all material respects with (i) all applicable Law in the Licensed Territory, (ii) the published standards debarment or disqualification or threatened debarment or disqualification of any applicable Regulatory Authorities in the Licensed Territory, and (iii) the scientific standards applicable person providing services to Licensee with respect to any activities relating to the conduct of Compound or Products, Licensee will immediately notify Allogene in writing and Licensee will cease employing, contracting with, or retaining any such studies and activities in person to perform any services relating to the Licensed Territory, including current good laboratory practice, current good clinical practice and current good manufacturing practiceCompound or Products; (b) it Licensee will preparenot, maintain and retain all Regulatory Materials in the Licensed Territory pursuant to and in accordance in all material respects with all applicable Law and will not make any materially false or misleading statement to a Regulatory Authority in connection with such Regulatory Materialsthe performance of its obligations under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other person for purpose of obtaining or retaining business for or with, or directing business to, any person, including Licensee, nor will Licensee directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other person in connection with the performance of Licensee’s obligations under this Agreement, which promise, offer, payment, or other act would be illegal under any Applicable Law; (c) it will not knowingly employ any personnel or knowingly use a contractor or consultant that Licensee has been debarred or subject in place an anti-corruption and anti-bribery policy and in connection with the performance of its obligations under this Agreement, Licensee shall comply and shall cause its and its Affiliates’ employees to a similar sanction by any Regulatory Authority or that is the subject of any investigation or proceeding comply with respect theretoLicensee’s policy; (d) during the Term and for a period of [***] thereafter, Licensee shall notshall, and shall cause ensure that its Affiliates and Sublicensees and its and their respective employees and contractors will, not tocause Allogene to be in violation of the FCPA, directly or indirectly, develop, manufacture, market, promote, import, exportExport Control Laws, or sellany other Applicable Laws, or assist including any Third Partyother applicable anti-corruption and anti-bribery laws, directly or indirectly, to develop, manufacture, market, promote, import, export, or sell anywhere in the world, any generic version of the Product without the prior written consent of TESARO (collectively, “Competing Activities”); provided, that if Licensee is merged or consolidated with a Third Party or enters into any transaction with a Third Party that, in either case, is at the time of entering into the transaction, engaged in Competing Activities and, as a result of such transaction becomes an Affiliate of Licensee (a “Subject Transaction”), nothing in this section shall restrict such Third Party or its Affiliates (“Post-Execution Affiliate”) from continuing to pursue or engage in the research, development, manufacture or commercialization of any product in connection with programs of such Post-Execution Affiliate existing prior to the effective time of such Subject Transaction, provided that: (1) Licensee shall provide TESARO with written notice of any such Subject Transaction within [***] following the earlier of the first public announcement of the execution of any agreement with respect to such Subject Transaction and the closing date of such Subject Transaction; and (2) such Post-Execution Affiliate’s Competing Activities shall be kept separate from the activities performance of Licensee’s obligations under this Agreement; (e) Licensee shall seek TESARO’s input immediately notify Allogene if it has any information or suspicion that there may be a violation of the FCPA, Export Control Laws, or any other Applicable Laws, including any other applicable anti-corruption and anti-bribery laws, in connection with the performance of its determination of obligations under this Agreement; (f) To the following matters: extent applicable, Licensee shall, and require each Sublicensee to covenant and agree in the applicable sublicense agreement that such Sublicensee shall (i) the last (A) not modify or reverse engineer or attempt to expire Valid Claim that prevents the entry of a Generic Product in Japan; and (ii) the expiration of the Drug Re-Examination Period for the primary indication of the Product in Japan (the last of (i) and (ii) to occur, the “Expiration Event”). modify or reverse engineer [***], and (B) shall assign, and does presently assign, to Upstream Licensor 1 all property rights, Know-How, Patents and other intellectual property rights in or to any animal cell or other biological material resulting from activities that constitute a breach of the foregoing clause (A), (ii) shall comply with all Applicable Laws applicable to the care, handling, use and disposal of the Subject Antibodies or Subject Antibody Materials, and (iii) shall not use Subject Antibodies, Subject Antibody Materials or Allogene Technology beyond the scope of the rights granted under this Agreement; and (fg) During In the Termcourse of performing its obligations or exercising its rights under this Agreement, Licensee shall not amend, waive or otherwise modify (or consent to any of the foregoing) [***] in any manner that would reasonably be expected to conflict comply with the terms of this AgreementAgreement and all Applicable Laws, including as applicable, cGMP, GCP, and GLP standards. Licensee shall adopt policies and implement procedures to protect the consideration payable to TESARO hereunder for the rights confidentiality of any and licenses granted to Licensee, or the segregation of TESARO’s Confidential Information, including Licensed all Allogene Know-How and any other information related to the Licensed Compound or Product that is not part of the public domain, without TESARO’s prior written consentHow.