Additional Representations, Warranties and Covenants of Licensee. Licensee hereby represents, warrants, and covenants to Coherus that: (a) as of the Effective Date, Licensee is entitled to grant the rights and licenses granted to Coherus as set forth in this Agreement; (b) Licensee has not granted in the Territory as of the Effective Date, and will not grant during the Term, any right or license in or to any of the Licensee Patent Rights or Grant-Back IP that is in conflict with the rights or licenses granted to Coherus under this Agreement; (c) Licensee has in place policies related to ensuring that its business operations and practices are compliant with all Applicable Laws in the United States and the Territory relating to anti-corruption, including the Foreign Corrupt Practices Act of 1977, as amended, and those enacted to implement the OECD Convention on Combating Bribery of Foreign Officials in International Business Transactions. Coherus acknowledges that Licensee has provided to Coherus prior to the Effective Date copies of the following Licensee policies: (a) International Anticorruption Policy, (b) International Anticorruption Third Party Policy and (c) Code of Conduct (collectively, as such may be amended from time to time in accordance with Licensee’s customary practices, the “Policies and Codes”); (d) Licensee will use best efforts to ensure that, throughout the Term, it, its Affiliates, Sublicensees and agents comply with the Policies and Codes; (e) At Coherus’ reasonable request (including to permit Coherus to respond to inquiries regarding compliance with Applicable Laws), Licensee shall promptly provide to Coherus then-current copies of the Policies and Codes; and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (f) Licensee shall use best efforts to ensure that any Third Party who represents Licensee or its Affiliates in connection with, or who will be involved in performing, this Agreement or any related activity, shall certify to compliance with all applicable anti-corruption laws and the obligations set forth in the Policies and Codes prior to any involvement in this Agreement or any related activity.
Appears in 3 contracts
Samples: License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.)
Additional Representations, Warranties and Covenants of Licensee. Licensee hereby represents, warrants, warrants and covenants (as applicable) to Coherus Amarin that:
(a) as As of the Effective Date, Licensee is entitled solvent and has the ability to grant the rights pay and licenses granted to Coherus perform all of its obligations as set forth in and when such obligations become due, including payment obligations and other obligations under this Agreement;.
(b) Licensee has not granted in the Territory as As of the Effective Date, Licensee’s compensation programs for its Sales Representatives do not, and during the Term will not grant during with respect to the TermProduct, provide financial incentives for the promotion, sales, and marketing in violation of any right Applicable Laws or license in or to any of the Licensee Patent Rights or Grant-Back IP that is in conflict with the rights or licenses granted to Coherus under this Agreement;professional requirements.
(c) During the Term, Licensee’s medical, regulatory or legal teams will review all training materials and programs prior to use by Licensee to ensure that such training materials and programs are in accordance with the Commercialization Plan and the Regulatory Approvals and in compliance with Applicable Laws.
(d) During the Term, all Product used in Development Activities, or Commercialized, by, or under authority of, Licensee:
(i) shall be packaged, labeled, handled, stored and shipped by Licensee, in accordance with, and shall conform to, the applicable Product Specifications;
(ii) shall be packaged, labeled, handled, stored and shipped by Licensee in compliance with all Applicable Laws, including GMPs; and
(iii) shall, from and after the time shipped by Amarin hereunder, not contain any material that would cause the Product to be adulterated or misbranded within the meaning of Applicable Laws. 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.
(e) As of the Effective Date, no claim or demand of any Person has been asserted in writing to Licensee arising out of Licensee’s development, regulatory or commercialization activities with respect to any other products that could reasonably be expected to impact Licensee’s ability to perform any of its obligations under this Agreement, and no investigations are pending or, to the knowledge of Licensee, threatened relating to such activities.
(f) As of the Effective Date, to the knowledge of Licensee, Licensee has in place policies related to ensuring that its business operations and practices are compliant complied with all Applicable Laws in the United States and the Territory relating to anti-corruption, including the Foreign Corrupt Practices Act of 1977, as amended, and those enacted to implement the OECD Convention on Combating Bribery of Foreign Officials in International Business Transactions. Coherus acknowledges that Licensee has provided to Coherus prior to the Effective Date copies of the following Licensee policies: (a) International Anticorruption Policy, (b) International Anticorruption Third Party Policy and (c) Code of Conduct (collectively, as such may be amended from time to time in accordance with Licensee’s customary practices, the “Policies and Codes”);
(d) Licensee will use best efforts to ensure that, throughout the Term, it, its Affiliates, Sublicensees and agents comply with the Policies and Codes;
(e) At Coherus’ reasonable request (including to permit Coherus to respond to inquiries regarding compliance with Applicable Laws), Licensee shall promptly provide to Coherus then-current copies of the Policies and Codes; and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsall material respects.
(fg) As of the Effective Date, Licensee shall use best efforts has obtained assignments from the inventors of all inventorship rights relating to ensure that any Third Party who represents the Licensee or its Affiliates in connection withPatents which are owned by Licensee, or who will be involved in performingand, this Agreement or any related activityto the knowledge of Licensee, shall certify all such assignments of inventorship rights relating to compliance with all applicable anti-corruption laws such Licensee Patents are valid and the obligations set forth in the Policies and Codes prior to any involvement in this Agreement or any related activityenforceable.
Appears in 1 contract
Samples: Development, Commercialization and Supply Agreement (Amarin Corp Plc\uk)
Additional Representations, Warranties and Covenants of Licensee. Licensee hereby represents, warrants, warrants and covenants to Coherus Lilly that, as of the Effective Date:
9.3.1 Licensee’s compensation programs for its Sales Representatives do not, and will not, provide financial incentives for the promotion, sales, and marketing of the Product in violation of any Applicable Law or any professional requirements.
9.3.2 Licensee’s training materials and programs relating to Products will be in accordance with the Regulatory Approvals and Applicable Law.
9.3.3 All Product Commercialized or Manufactured by, or under authority of, Licensee shall be:
(a) packaged, labeled, handled, stored and shipped by Licensee, in accordance with, and shall conform to, the applicable Product Specifications;
(b) packaged, labeled, handled, stored and shipped by Licensee in compliance with all Applicable Law including, GMPs; and
(c) from and after the time delivered by Lilly hereunder or Manufactured by Licensee (as applicable), free of any material that would cause the Product to be adulterated or misbranded within the meaning of Applicable Law.
9.3.4 To the knowledge of Licensee, no claim or demand of any Person has been asserted in writing to Licensee that challenges the rights of Licensee to use or license any of the Licensee Technology.
9.3.5 To its knowledge, Licensee has complied with all Applicable Law, in all material respects, including any disclosure requirements, in connection with the filing, prosecution and maintenance of the Licensee Patents owned by Licensee.
9.3.6 Prior to the payment of the development milestone in Section 7.2, Licensee will earmark Twenty-Two Million Dollars ($22,000,000) of the funds paid to Licensee by Lilly, under that certain Stock Purchase Agreement entered into by the Parties as of the Effective Date, to be used solely for Development of the Products and payment of such milestone.
9.3.7 Licensee is entitled to grant its own Ultimate Parent Entity and the rights and licenses granted to Coherus as set forth transaction considered in this Agreement;
(b) Licensee has Agreement does not granted satisfy the jurisdictional thresholds described in the Territory as of the Effective Date, and will not grant during the Term, any right or license in or to any of the Licensee Patent Rights or Grant-Back IP that is in conflict with the rights or licenses granted to Coherus under this Agreement;
(c) Licensee has in place policies related to ensuring that its business operations and practices are compliant with all Applicable Laws in the United States and the Territory relating to anti-corruption, including the Foreign Corrupt Practices Act of 1977, as amended, and those enacted to implement the OECD Convention on Combating Bribery of Foreign Officials in International Business Transactions15 U.S.C. § 18a(B)(i). Coherus acknowledges that Licensee has provided to Coherus prior to the Effective Date copies of the following Licensee policies: (a) International Anticorruption Policy, (b) International Anticorruption Third Party Policy and (c) Code of Conduct (collectively, as such may be amended from time to time in accordance with Licensee’s customary practices, the “Policies and Codes”);
(d) Licensee will use best efforts to ensure that, throughout the Term, it, its Affiliates, Sublicensees and agents comply with the Policies and Codes;
(e) At Coherus’ reasonable request (including to permit Coherus to respond to inquiries regarding compliance with Applicable Laws), Licensee shall promptly provide to Coherus then-current copies of the Policies and Codes; and [***] Certain information Capitalized terms in this document has been omitted and filed separately with Section 9.3.7 have the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(f) Licensee shall use best efforts to ensure that any Third Party who represents Licensee or its Affiliates in connection with, or who will be involved in performing, this Agreement or any related activity, shall certify to compliance with all applicable anti-corruption laws and the obligations meaning set forth in the Policies Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976 and Codes prior to any involvement in this Agreement or any related activityapplicable regulations.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Ignyta, Inc.)
Additional Representations, Warranties and Covenants of Licensee. Licensee hereby represents, warrants, and covenants to Coherus that:
(a) as of the Effective Date, Licensee is entitled to grant the rights and licenses granted to Coherus as set forth in this Agreement;
(b) Licensee has not granted in the Territory as of the Effective Date, and will not grant during the Term, any right or license in or to any of the Licensee Patent Rights or Grant-Back IP that is in conflict with the rights or licenses granted to Coherus under this Agreement;
(c) Licensee has in place policies related to ensuring that its business operations and practices are compliant with all Applicable Laws in the United States and the Territory relating to anti-corruption, including the Foreign Corrupt Practices Act of 1977, as amended, and those enacted to implement the OECD Convention on Combating Bribery of Foreign Officials in International Business Transactions. Coherus acknowledges that Licensee has provided to Coherus prior to the Effective Date copies of the following Licensee policies: (a) International Anticorruption Policy, (b) International Anticorruption Third Party Policy and (c) Code of Conduct (collectively, as such may be amended from time to time in accordance with Licensee’s customary practices, the “Policies and Codes”);
(d) Licensee will use best efforts to ensure that, throughout the Term, it, its Affiliates, Sublicensees and agents comply with the Policies and Codes;
(e) At Coherus’ reasonable request (including to permit Coherus to respond to inquiries regarding compliance with Applicable Laws), Licensee shall promptly provide to Coherus then-current copies of the Policies and Codes; and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.and
(f) Licensee shall use best efforts to ensure that any Third Party who represents Licensee or its Affiliates in connection with, or who will be involved in performing, this Agreement or any related activity, shall certify to compliance with all applicable anti-anti- corruption laws and the obligations set forth in the Policies and Codes prior to any involvement in this Agreement or any related activity.
Appears in 1 contract
Additional Representations, Warranties and Covenants of Licensee. Licensee hereby representsrepresents and warrants and, warrantson behalf of itself and its Affiliates, agrees and covenants to Coherus thatas follows:
11.3.1 To the extent permitted by Applicable Law, in any country, region or jurisdiction in the Territory, Licensee, on behalf of its Affiliates, agrees and covenants never to institute or prosecute any claim, action or suit at law or in equity seeking to have any claim in a NovaDel Patent declared invalid or unenforceable; provided, however, that nothing contained herein shall prohibit Licensee and its Affiliates and Sublicensees from either (a) as asserting any and all defenses available to it, including assertions relating to the validity or enforceability of the Effective DateNovaDel Patents, Licensee is entitled to grant in any suit or proceeding brought against them alleging the rights and licenses granted to Coherus as set forth in this Agreement;
infringement of any of the NovaDel Patents, or (b) Licensee has not granted in the Territory as asserting any and all defenses, evidence and arguments, including lack of patentability of the Effective Datesubject matter of a count or claim and lack of support for a count or claim, and will not grant during the Term, in any right interference involving a patent or license in or to any of the Licensee Patent Rights or Grant-Back IP that is in conflict with the rights or licenses granted to Coherus under this Agreement;
(c) Licensee has in place policies related to ensuring that its business operations and practices are compliant with all Applicable Laws in the United States and the Territory relating to anti-corruption, including the Foreign Corrupt Practices Act of 1977, as amended, and those enacted to implement the OECD Convention on Combating Bribery of Foreign Officials in International Business Transactions. Coherus acknowledges that Licensee has provided to Coherus prior to the Effective Date copies of the following Licensee policies: (a) International Anticorruption Policy, (b) International Anticorruption Third Party Policy and (c) Code of Conduct (collectively, as such may be amended from time to time in accordance with Licensee’s customary practices, the “Policies and Codes”);
(d) Licensee will use best efforts to ensure that, throughout the Term, it, its Affiliates, Sublicensees and agents comply with the Policies and Codes;
(e) At Coherus’ reasonable request (including to permit Coherus to respond to inquiries regarding compliance with Applicable Laws), Licensee shall promptly provide to Coherus then-current copies of the Policies and Codes; and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(f) Licensee shall use best efforts to ensure that any Third Party who represents patent application owned by Licensee or its Affiliates or Sublicensees and a patent or patent application included within the definition of the NovaDel Patents.
11.3.2 Except as the Parties otherwise agree pursuant to the terms of an applicable sublicense, Licensee shall include covenants in connection withits agreements with each of its Sublicensees materially identical to those Licensee is making in Sections 11.3.1 and 11.3.2 on the part of the Sublicensee, or who will and shall provide that NovaDel shall have march-in right to seek termination of such agreement in the event the Sublicensee breaches the covenant. NovaDel’s right to seek termination of such agreement with the Sublicensee shall be involved in performingsubject to notice, this Agreement or any related activity, shall certify cure ***Portion for which confidential treatment requested. and dispute resolutions provisions materially identical to compliance with all applicable anti-corruption laws and the obligations provisions set forth in Article 9. Licensee and its Affiliates will take all reasonable action (including signing required documents) and offer full cooperation to allow NovaDel to exercise the Policies and Codes prior march-in rights provided herein, to any involvement in this Agreement or any related activitythe extent permitted by law.
Appears in 1 contract
Samples: License and Development Agreement (Novadel Pharma Inc)
Additional Representations, Warranties and Covenants of Licensee. Licensee hereby representsrepresents and warrants and, warrantson behalf of itself and its Affiliates, agrees and covenants to Coherus thatas follows:
11.3.1 To the extent permitted by Applicable Law, in any country, region or jurisdiction in the Territory, Licensee, on behalf of its Affiliates, agrees and covenants never to institute or prosecute any claim, action or suit at law or in equity seeking to have any claim in a NovaDel Patent declared invalid or unenforceable; provided, however, that nothing contained herein shall prohibit Licensee and its Affiliates and Sublicensees from either (a) as asserting any and all defenses available to it, including assertions relating to the validity or enforceability of the Effective DateNovaDel Patents, Licensee is entitled to grant in any suit or proceeding brought against them alleging the rights and licenses granted to Coherus as set forth in this Agreement;
infringement of any of the NovaDel Patents, or (b) Licensee has not granted in the Territory as asserting any and all defenses, evidence and arguments, including lack of patentability of the Effective Datesubject matter of a count or claim and lack of support for a count or claim, and will not grant during the Term, in any right interference involving a patent or license in or to any of the Licensee Patent Rights or Grant-Back IP that is in conflict with the rights or licenses granted to Coherus under this Agreement;
(c) Licensee has in place policies related to ensuring that its business operations and practices are compliant with all Applicable Laws in the United States and the Territory relating to anti-corruption, including the Foreign Corrupt Practices Act of 1977, as amended, and those enacted to implement the OECD Convention on Combating Bribery of Foreign Officials in International Business Transactions. Coherus acknowledges that Licensee has provided to Coherus prior to the Effective Date copies of the following Licensee policies: (a) International Anticorruption Policy, (b) International Anticorruption Third Party Policy and (c) Code of Conduct (collectively, as such may be amended from time to time in accordance with Licensee’s customary practices, the “Policies and Codes”);
(d) Licensee will use best efforts to ensure that, throughout the Term, it, its Affiliates, Sublicensees and agents comply with the Policies and Codes;
(e) At Coherus’ reasonable request (including to permit Coherus to respond to inquiries regarding compliance with Applicable Laws), Licensee shall promptly provide to Coherus then-current copies of the Policies and Codes; and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(f) Licensee shall use best efforts to ensure that any Third Party who represents patent application owned by Licensee or its Affiliates or Sublicensees and a patent or patent application included within the definition of the NovaDel Patents.
11.3.2 Except as the Parties otherwise agree pursuant to the terms of an applicable sublicense, Licensee shall include covenants in connection withits agreements with each of its Sublicensees materially identical to those Licensee is making in Sections 11.3.1 and 11.3.2 on the part of the Sublicensee, or who will and shall provide that NovaDel shall have march-in right to seek termination of such agreement in the event the Sublicensee breaches the covenant. NovaDel’s right to seek termination of such agreement with the Sublicensee shall be involved in performingsubject to notice, this Agreement or any related activity, shall certify cure and dispute resolutions provisions materially identical to compliance with all applicable anti-corruption laws and the obligations provisions set forth in Article 9. Licensee and its Affiliates will take all reasonable action (including signing required documents) and offer full cooperation to allow NovaDel to exercise the Policies and Codes prior march-in rights provided herein, to any involvement in this Agreement or any related activitythe extent permitted by law.
Appears in 1 contract
Samples: License and Development Agreement (Hana Biosciences Inc)