Common use of Biosimilars Litigation Clause in Contracts

Biosimilars Litigation. In the event that a Product within the scope of this collaboration is a New Biologic Entity in accordance with the definition, applied by the responsible regulatory authority, and in the case of doubt in accordance with the definition specified in the “Biologics Price Competition and Innovation Act of 2009” (the “Biosimilars Act”), and if generic companies might enter the market with a Biosimilar Product equivalent to a Product, the following provisions shall apply: If a Third Party (“Biosimilars Applicant”) has submitted an application (a “BLA”) under 42 U.S.C. §262(k) (approval pathway for biosimilar biological products) of the Biosimilars Act, or under a comparable provision of applicable law outside of the United States, for licensure of a biological product referencing a Product as the reference listed product, 131 shall, no later than five (5) days after receipt of a copy of the BLA, provide Zealand Pharma with notice thereof. If Zealand Pharma wishes to receive a copy of such BLA and other confidential information received by BI from the Biosimilars Applicant with respect to such BLA (the “BLA Materials”) and to receive the other information called for in this Section 14.9.2, and if such provision of materials to Zealand Pharma is subject to the Biosimilars Act, Zealand Pharma shall, within five (5) days of the receipt of such notice from BI, provide written notice to BI and the Biosimilars Applicant of its agreement to be subject to the confidentiality provisions of 42 U.S.C. § 262(1). Within five (5) days after receipt by BI of written confirmation that such notice has been provided to Xxxxx the Biosimilars Applicant, BI shall provide the BLA Materials to a representative of Zealand Pharma authorized to receive such materials under 42 U.S.C. § 262(1)(1)(B)(ii). Promptly after receiving any new BLA Materials from the Biosimilars Applicant, BI shall provide a copy of such information to such Zealand Pharma representative. Except as otherwise set forth herein, BI shall have exclusive control over, and shall bear the expense of, any exchange of information with a Biosimilars Applicant required under the Biosimilars Act or other comparable applicable ex-U.S. laws, the initiation, conduct and settlement of any patent infringement actions brought against the Biosimilars Applicant pursuant to the Biosimilars Act and any licensing of the Licensed Patents and Selected Zealand Pharma Patents to the Biosimilars Applicant pursuant to the Biosimilars Act or other [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. comparable applicable ex-U.S. laws. Zealand Pharma shall assist Xxxxx cooperate with BI by: (i) disclosing to 81, upon request by BI and within ten (10) Business Days, all Zealand Pharma Patents that Zealand Pharma believes cover such Product; (ii) granting BI the right to decide which Zealand Pharma Patents and Collaboration Patents to disclose under the patent exchange provisions of the Biosimilars Act (42 U.S.C. § 262(1)), provided that BI shall provide Zealand Pharma, reasonably in advance of disclosure to the Biosimilars Applicant, its proposed disclosure under such patent exchange provisions and BI reasonably shall consider Zealand Pharma’s views as to which Licensed Patents and Selected Zealand Pharma Patents should be disclosed, and provided further that BI shall not exclude from such disclosure any Licensed Patent or Selected Zealand Pharma Patent that BI believes could reasonably be asserted in a patent infringement claim against the Biosimilars Applicant with respect to the Biosimilar Product that is the subject of the BLA; (iii) providing BI, upon request by BI and within ten (10) Business Days, with reasonable assistance so that BI may develop claim by claim rebuttals to any non-infringement arguments and unenforceability or invalidity challenges made by such applicant on any of such Zealand Pharma Patents (42 U.S.C. § 262(I)(3)(B) and (C)), and BI reasonably shall consider Zealand Pharma’s view in connection with the foregoing, provided that in no event may BI, without Zealand Pharma’s written consent, admit to the invalidity or unenforceability of any Licensed Patents or Selected Zealand Pharma Patent; and (iv) providing to BI, before and during litigation, at BI’s expense, any other support that will be necessary or reasonably useful to secure BI’s rights as the reference product sponsor under 42 U.S.C. § 262 or under an equivalent provision. BI shall bring and diligently pursue an action against the Biosimilars Applicant for patent infringement of any Licensed Patents and Selected Zealand Pharma Patents as required by 42 U.S.C. § 262(1)(6), unless otherwise agreed by Zealand Pharma. BI shall keep Zealand Pharma reasonably apprised of patent resolution negotiations engaged in between BI and the Biosimilars Applicant pursuant to 42 U.S.C. § 262(1)(4) (or pursuant to any equivalent provision of ex-U.S: applicable law). [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions.

Biosimilars Litigation. In the event that a Product within the scope of this collaboration is a New Biologic Entity in accordance with the definition, applied by the responsible regulatory authority, and in the case of doubt in accordance with the definition specified in the “Biologics Price Competition and Innovation Act of 2009” (the “Biosimilars Act”), and if generic companies might enter the market with a Biosimilar Product equivalent to a Product, the following provisions shall apply: . If a Third Party (“Biosimilars Applicant”) ), has submitted an application (a “BLA”) under 42 U.S.C. §262(k) (approval pathway for biosimilar biological products) of the Biosimilars Act, or under a comparable provision of applicable law outside of the United States, for licensure of a biological product referencing a Product as the reference listed product, 131 BI shall, no later than five (5) days after receipt of a copy of the BLA, provide Zealand Pharma with notice thereof. If Zealand Pharma wishes to receive a copy of such BLA and other confidential information received by BI from the Biosimilars Applicant with respect to such BLA (the “BLA Materials”) and to receive the other information called for in this Section 14.9.2, and if such provision of materials to Zealand Pharma is subject to the Biosimilars Act, Zealand Pharma shall, within five (5) days of the receipt of such notice from BI, provide written notice to BI and the Biosimilars Applicant of its agreement to be subject to the confidentiality provisions of 42 U.S.C. § 262(1). Within five (5) days after receipt by BI of written confirmation that such notice has been provided to Xxxxx BI and the Biosimilars Applicant, BI shall provide the BLA Materials to a representative of Zealand Pharma authorized to receive such materials [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. under 42 U.S.C. § 262(1)(1)(B)(ii262(I)(1)(B)(ii). Promptly after receiving any new BLA Materials from the Biosimilars Applicant, BI shall provide a copy of such information to such Zealand Pharma representative. Except as otherwise set forth herein, BI shall have exclusive control over, and shall bear the expense of, any exchange of information with a Biosimilars Applicant required under the Biosimilars Act or other comparable applicable ex-U.S. laws, the initiation, initiation conduct and settlement of any patent infringement actions brought against the Biosimilars Applicant pursuant to the Biosimilars Act and any licensing of the Licensed Patents and Selected Zealand Pharma Patents to the Biosimilars Applicant pursuant to the Biosimilars Act or other [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. comparable applicable ex-U.S. laws. Zealand Pharma shall assist Xxxxx BI and cooperate with BI by:. (i) disclosing to 81BI, upon request by BI and within ten (10) Business Days, all Zealand Pharma Patents that Zealand Pharma believes cover such Product; (ii) granting BI the right to decide which Zealand Pharma Patents and Collaboration Patents to disclose under the patent exchange provisions of the Biosimilars Act (42 U.S.C. § 262(1)), provided that BI shall provide Zealand Pharma, reasonably in advance of disclosure to the Biosimilars Applicant, its proposed disclosure under such patent exchange provisions and BI reasonably shall consider Zealand Pharma’s views as to which Licensed Patents and Selected Zealand Pharma Patents should be disclosed, and provided further that BI shall not exclude from such disclosure any Licensed Patent or Selected Zealand Pharma Patent that BI believes could reasonably be asserted in a patent infringement claim against the Biosimilars Applicant with respect to the Biosimilar Product that is the subject of the BLA; (iii) providing BI, upon request by BI and within ten (10) Business Days, with reasonable assistance so that BI may develop claim by claim rebuttals to any non-infringement arguments and unenforceability or invalidity challenges made by such applicant on any of such Zealand Pharma Patents (42 U.S.C. § 262(I)(3)(B262(1)(3)(b) and (Cc)), and BI reasonably shall consider Zealand Pharma’s view in connection with the foregoing, provided that in no event may BI, without Zealand Pharma’s written consent, admit to the invalidity or unenforceability of any Licensed Patents or Selected Zealand Pharma Patent; and (iv) providing to BI, before and during litigation, at BI’s expense, any other support that will be necessary or reasonably useful to secure BI’s rights as the reference product sponsor under 42 U.S.C. § 262 or under an equivalent provision. [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. BI shall bring and diligently pursue an action against the Biosimilars Applicant for patent infringement of any Licensed Patents and Selected Zealand Pharma Patents as required by 42 U.S.C. § 262(1)(6), unless otherwise agreed by Zealand Pharma. BI shall keep Zealand Pharma reasonably apprised of patent resolution negotiations engaged in between BI and the Biosimilars Applicant pursuant to 42 U.S.C. § 262(1)(4) (or pursuant to any equivalent provision of ex-U.S: U.S. applicable law). [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions.

Biosimilars Litigation. In the event that a Product within the scope of this collaboration is a New Biologic Entity in accordance with the definition, applied by the responsible regulatory authority, and in the case of doubt in accordance with the definition specified in the “Biologics Price Competition and Innovation Act of 2009” (the “Biosimilars Act”), and if generic companies might enter the market with a Biosimilar Product equivalent to a Product, the following provisions shall apply: . If a Third Party (“Biosimilars Applicant”) ), has submitted an application (a “BLA”) under 42 U.S.C. §262(k) (approval pathway for biosimilar biological products) of the Biosimilars Act, or under a comparable provision of applicable law outside of the United States, for licensure of a biological product referencing a Product as the reference listed product, 131 BI shall, no later than five (5) days after receipt of a copy of the BLA, provide Zealand Pharma with notice thereof. If Zealand Pharma wishes [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. to receive a copy of such BLA and other confidential information received by BI from the Biosimilars Applicant with respect to such BLA (the “BLA Materials”) and to receive the other information called for in this Section 14.9.2, and if such provision of materials to Zealand Pharma is subject to the Biosimilars Act, Zealand Pharma shall, within five (5) days of the receipt of such notice from BI, provide written notice to BI and the Biosimilars Applicant of its agreement to be subject to the confidentiality provisions of 42 U.S.C. § 262(1). Within five (5) days after receipt by BI of written confirmation that such notice has been provided to Xxxxx BI and the Biosimilars Applicant, BI shall provide the BLA Materials to a representative of Zealand Pharma authorized to receive such materials under 42 U.S.C. § 262(1)(1)(B)(ii262(I)(1)(B)(ii). Promptly after receiving any new BLA Materials from the Biosimilars Applicant, BI shall provide a copy of such information to such Zealand Pharma representative. Except as otherwise set forth herein, BI shall have exclusive control over, and shall bear the expense of, any exchange of information with a Biosimilars Applicant required under the Biosimilars Act or other comparable applicable ex-U.S. laws, the initiation, initiation conduct and settlement of any patent infringement actions brought against the Biosimilars Applicant pursuant to the Biosimilars Act and any licensing of the Licensed Patents and Selected Zealand Pharma Patents to the Biosimilars Applicant pursuant to the Biosimilars Act or other [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. comparable applicable ex-U.S. laws. Zealand Pharma shall assist Xxxxx BI and cooperate with BI by:. (i) disclosing to 81BI, upon request by BI and within ten (10) Business Days, all Zealand Pharma Patents that Zealand Pharma believes cover such Product; (ii) granting BI the right to decide which Zealand Pharma Patents and Collaboration Patents to disclose under the patent exchange provisions of the Biosimilars Act (42 U.S.C. § 262(1)), provided that BI shall provide Zealand Pharma, reasonably in advance of disclosure to the Biosimilars Applicant, its proposed disclosure under such patent exchange provisions and BI reasonably shall consider Zealand Pharma’s views as to which Licensed Patents and Selected Zealand Pharma Patents should be disclosed, and provided further that BI shall not exclude from such disclosure any Licensed Patent or Selected Zealand Pharma Patent that BI believes could reasonably be asserted in a patent infringement claim against the Biosimilars Applicant with respect to the Biosimilar Product that is the subject of the BLA; (iii) providing BI, upon request by BI and within ten (10) Business Days, with reasonable assistance so that BI may develop claim by [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. claim rebuttals to any non-infringement arguments and unenforceability or invalidity challenges made by such applicant on any of such Zealand Pharma Patents (42 U.S.C. § 262(I)(3)(B262(1)(3)(b) and (Cc)), and BI reasonably shall consider Zealand Pharma’s view in connection with the foregoing, provided that in no event may BI, without Zealand Pharma’s written consent, admit to the invalidity or unenforceability of any Licensed Patents or Selected Zealand Pharma Patent; and (iv) providing to BI, before and during litigation, at BI’s expense, any other support that will be necessary or reasonably useful to secure BI’s rights as the reference product sponsor under 42 U.S.C. § 262 or under an equivalent provision. BI shall bring and diligently pursue an action against the Biosimilars Applicant for patent infringement of any Licensed Patents and Selected Zealand Pharma Patents as required by 42 U.S.C. § 262(1)(6), unless otherwise agreed by Zealand Pharma. BI shall keep Zealand Pharma reasonably apprised of patent resolution negotiations engaged in between BI and the Biosimilars Applicant pursuant to 42 U.S.C. § 262(1)(4) (or pursuant to any equivalent provision of ex-U.S: U.S. applicable law). [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions.

Biosimilars Litigation. In the event that a Product within the scope of this collaboration is a New Biologic Entity in accordance with the definition, applied by the responsible regulatory authority, and in the case of doubt in accordance with the definition specified in the “Biologics Price Competition and Innovation Act of 2009” (the “Biosimilars Act”), and if generic companies might enter the market with a Biosimilar Product equivalent to a Product, the following provisions shall apply: If a Third Party (“Biosimilars Applicant”) has submitted an application (a “BLA”) under 42 U.S.C. §262(k) (approval pathway for biosimilar biological products) of the Biosimilars Act, or under a comparable provision of applicable law outside of the United States, for licensure of a biological product referencing a Product as the reference listed product, 131 shall, no later than five (5) days after receipt of a copy of the BLA, provide Zealand Pharma with notice thereof. If Zealand Pharma wishes to receive a copy of such BLA and other confidential information received by BI from the Biosimilars Applicant with respect to such BLA (the “BLA Materials”) and to receive the other information called for in this Section 14.9.2, and if such provision of materials to Zealand Pharma is subject to the Biosimilars Act, Zealand Pharma shall, within five (5) days of the receipt of such notice from BI, provide written notice to BI and the Biosimilars Applicant of its agreement to be subject to the confidentiality provisions of 42 U.S.C. § 262(1). Within five (5) days after receipt by BI of written confirmation that such notice has been provided to Xxxxx the Biosimilars Applicant, BI shall provide the BLA Materials to a representative of Zealand Pharma authorized to receive such materials under 42 U.S.C. § 262(1)(1)(B)(ii). Promptly after receiving any new BLA Materials from the Biosimilars Applicant, BI shall provide a copy of such information to such Zealand Pharma representative. [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. Except as otherwise set forth herein, BI shall have exclusive control over, and shall bear the expense of, any exchange of information with a Biosimilars Applicant required under the Biosimilars Act or other comparable applicable ex-U.S. laws, the initiation, conduct and settlement of any patent infringement actions brought against the Biosimilars Applicant pursuant to the Biosimilars Act and any licensing of the Licensed Patents and Selected Zealand Pharma Patents to the Biosimilars Applicant pursuant to the Biosimilars Act or other [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. comparable applicable ex-U.S. laws. Zealand Pharma shall assist Xxxxx cooperate with BI by: (i) disclosing to 81, upon request by BI and within ten (10) Business Days, all Zealand Pharma Patents that Zealand Pharma believes cover such Product; (ii) granting BI the right to decide which Zealand Pharma Patents and Collaboration Patents to disclose under the patent exchange provisions of the Biosimilars Act (42 U.S.C. § 262(1)), provided that BI shall provide Zealand Pharma, reasonably in advance of disclosure to the Biosimilars Applicant, its proposed disclosure under such patent exchange provisions and BI reasonably shall consider Zealand Pharma’s views as to which Licensed Patents and Selected Zealand Pharma Patents should be disclosed, and provided further that BI shall not exclude from such disclosure any Licensed Patent or Selected Zealand Pharma Patent that BI believes could reasonably be asserted in a patent infringement claim against the Biosimilars Applicant with respect to the Biosimilar Product that is the subject of the BLA; (iii) providing BI, upon request by BI and within ten (10) Business Days, with reasonable assistance so that BI may develop claim by claim rebuttals to any non-infringement arguments and unenforceability or invalidity challenges made by such applicant on any of such Zealand Pharma Patents (42 U.S.C. § 262(I)(3)(B) and (C)), and BI reasonably shall consider Zealand Pharma’s view in connection with the foregoing, provided that in no event may BI, without Zealand Pharma’s written consent, admit to the invalidity or unenforceability of any Licensed Patents or Selected Zealand Pharma Patent; and (iv) providing to BI, before and during litigation, at BI’s expense, any other support that will be necessary or reasonably useful to secure BI’s rights as the reference product sponsor under 42 U.S.C. § 262 or under an equivalent provision. [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. BI shall bring and diligently pursue an action against the Biosimilars Applicant for patent infringement of any Licensed Patents and Selected Zealand Pharma Patents as required by 42 U.S.C. § 262(1)(6), unless otherwise agreed by Zealand Pharma. BI shall keep Zealand Pharma reasonably apprised of patent resolution negotiations engaged in between BI and the Biosimilars Applicant pursuant to 42 U.S.C. § 262(1)(4) (or pursuant to any equivalent provision of ex-U.S: applicable law). [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions.