Common use of Paragraph IV Proceedings Clause in Contracts

Paragraph IV Proceedings. With respect to any notification provided by a Third Party to BI or Zealand Pharma under 21 U.S.C. § 355 (j)(2)(B) with respect to Zealand Pharma Patents, Selected Zealand Pharma Patents or Collaboration Patents that are listed for a Product on the then-current edition of the FDA publication “Approved Drug Products With Therapeutic Equivalence Evaluations”, or equivalent actions in other countries (each a “Paragraph IV Proceeding”), the following shall apply: (a) Without any avoidable delay, however at the latest within five (5) Business Days of learning of any Paragraph IV Proceeding, such [***] 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. Party shall notify the other Party. BI and Zealand Pharma shall thereafter consult and cooperate fully to determine a course of action with respect to any such proceeding. (b) BI shall have the initial right to initiate and/or defend any Paragraph IV Proceeding, including by commencing a patent infringement action under 35 U.S.C. §271(e)(2)(A), and shall bear the expense of any Paragraph IV Proceeding. If BI elects not to commence a patent infringement action against the Third Party under 35 U.S.C. §271(e)(2)(A), it shall notify Zealand Pharma of such election no later than twenty five (25) calendar days after the earlier of Zealand Pharma’s or BI’s receipt of the notice provided pursuant to 21 U.S.C. §355(1)(2)(B) and, in such case, Zealand Pharma shall have the sole right to commence such patent infringement action at its expense, and, legally required, in BI’s or the relevant BI Affiliate’s name and on BI’s or the relevant BI Affiliate’s behalf. In addition, Zealand Pharma shall have the sole right to commence such patent infringement action, at its expense, if BI has not commenced such action by the date that is twenty five (25) calendar days after the earlier of Zealand Pharma’s or Nis receipt of the notice required by 21 U.S.C. §355(j)(2)(B), or continue the prosecution of such infringement action if at any time BI fails to diligently do so, and in each case, if legally required, in BI’s or the relevant BI Affiliate’s name and on BI s or the relevant BI Affiliate’s behalf. (c) Except as set forth above, Zealand Pharma shall not initiate any Paragraph IV Proceeding without the prior written consent of BI, which consent shall not be unreasonably delayed or denied.

Paragraph IV Proceedings. With respect to any notification provided by a Third Party to BI or Zealand Pharma under 21 U.S.C. § 355 (j)(2)(B) with respect to Zealand Pharma Patents, Selected Zealand Pharma Patents or Collaboration Patents that are listed for a Product on the then-current edition of the FDA publication “Approved Drug Products With Therapeutic Equivalence Evaluations”, or equivalent actions in other countries (each a “Paragraph IV Proceeding”), the following shall apply: (a) Without any avoidable delay, however at the latest within five (5) Business Days of learning of any Paragraph IV Proceeding, such [***] 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. Party shall notify the other Party. BI and Zealand Pharma shall thereafter consult and cooperate fully to determine a course of action with respect to any such proceeding. (b) BI shall have the initial right to initiate and/or defend any Paragraph IV Proceeding, including by commencing a patent infringement action under 35 U.S.C. §271(e)(2)(A), and shall bear the expense of any Paragraph IV Proceeding. If BI elects not to commence a patent infringement action against the Third Party under 35 U.S.C. §271(e)(2)(A), it shall notify Zealand Pharma of such election no later than twenty five (25) calendar days after the earlier of Zealand Pharma’s or BI’s receipt of the notice provided pursuant to 21 U.S.C. §355(1)(2)(B355(j)(2)(B) and, in such case, Zealand Pharma shall have the sole right to commence such patent infringement action action, at its expense, and, if legally required, in BI’s or the relevant BI Affiliate’s name and on BI’s or the relevant BI Affiliate’s behalf. In addition, Zealand Pharma shall have the sole right to commence such patent infringement action, at its expense, if BI has not commenced such action by the date that is twenty five (25) calendar days after the earlier of Zealand Pharma’s or Nis BI’s receipt of the notice required by 21 U.S.C. §355(j)(2)(B), or continue the prosecution of such infringement action if at any time BI [***] 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. fails to diligently do so, and in each case, if legally required, in BI’s or the relevant BI Affiliate’s name and on BI s BI’s or the relevant BI Affiliate’s behalf. (c) Except as set forth above, Zealand Pharma shall not initiate any Paragraph IV Proceeding without the prior written consent of BI, which consent shall not be unreasonably delayed or denied.

Paragraph IV Proceedings. With respect to any notification provided by a Third Party to BI or Zealand Pharma under 21 U.S.C. § 355 (j)(2)(B) with respect to Zealand Pharma Patents, Selected Zealand Pharma Patents or Collaboration Patents that are listed for a Product on the then-current edition of the FDA publication “Approved Drug Products With Therapeutic Equivalence Evaluations”, or equivalent actions in other countries (each a “Paragraph IV Proceeding”), the following shall apply: (a) Without any avoidable delay, however at the latest within five (5) Business Days of learning of any Paragraph IV Proceeding, such [***] 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. Party shall notify the other Party. BI and Zealand Pharma shall thereafter consult and cooperate fully to determine a course of action with respect to any such proceeding. (b) BI shall have the initial right to initiate and/or defend any Paragraph IV Proceeding, including by commencing a patent infringement action under 35 U.S.C. §271(e)(2)(A), and shall bear the expense of any Paragraph IV Proceeding. If BI elects not to commence a patent infringement action against the Third Party under 35 U.S.C. §271(e)(2)(A), it shall notify Zealand Pharma of such election no [***] 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. later than twenty five (25) calendar days after the earlier of Zealand Pharma’s or BI’s receipt of the notice provided pursuant to 21 U.S.C. §355(1)(2)(B) and, in such case, Zealand Pharma shall have the sole right to commence such patent infringement action at its expense, and, legally required, in BI’s or the relevant BI Affiliate’s name and on BI’s or the relevant BI Affiliate’s behalf. In addition, Zealand Pharma shall have the sole right to commence such patent infringement action, at its expense, if BI has not commenced such action by the date that is twenty five (25) calendar days after the earlier of Zealand Pharma’s or Nis receipt of the notice required by 21 U.S.C. §355(j)(2)(B), or continue the prosecution of such infringement action if at any time BI fails to diligently do so, and in each case, if legally required, in BI’s or the relevant BI Affiliate’s name and on BI s or the relevant BI Affiliate’s behalf. (c) Except as set forth above, Zealand Pharma shall not initiate any Paragraph IV Proceeding without the prior written consent of BI, which consent shall not be unreasonably delayed or denied.

Paragraph IV Proceedings. With respect to any notification provided by a Third Party to BI or Zealand Pharma under 21 U.S.C. § 355 (j)(2)(B) with respect to Zealand Pharma Patents, Selected Zealand Pharma Patents or Collaboration Patents that are listed for a Product on the then-current edition of the FDA publication “Approved Drug Products With Therapeutic Equivalence Evaluations”, or equivalent actions in other countries (each a “Paragraph IV Proceeding”), the following shall apply: (a) Without any avoidable delay, however at the latest within five (5) Business Days of learning of any Paragraph IV Proceeding, such [***] 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. Party shall notify the other Party. BI and Zealand Pharma shall thereafter consult and cooperate fully to determine a course of action with respect to any such proceeding. (b) BI shall have the initial right to initiate and/or defend any Paragraph IV Proceeding, including by commencing a patent infringement action under 35 U.S.C. §271(e)(2)(A), and shall bear the expense of any Paragraph IV Proceeding. If BI elects not to commence a patent infringement action against the Third Party under 35 U.S.C. §271(e)(2)(A), it shall notify Zealand Pharma of such election no later than twenty five (25) calendar days after the earlier of Zealand Pharma’s or BI’s receipt of the notice provided pursuant to 21 U.S.C. §355(1)(2)(B355(j)(2)(B) and, in such case, Zealand Pharma shall have the sole right to commence such patent infringement action action, at its expense, and, if legally required, in BI’s or the relevant BI Affiliate’s name and on [***] 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’s or the relevant BI Affiliate’s behalf. In addition, Zealand Pharma shall have the sole right to commence such patent infringement action, at its expense, if BI has not commenced such action by the date that is twenty five (25) calendar days after the earlier of Zealand Pharma’s or Nis BI’s receipt of the notice required by 21 U.S.C. §355(j)(2)(B), or continue the prosecution of such infringement action if at any time BI fails to diligently do so, and in each case, if legally required, in BI’s or the relevant BI Affiliate’s name and on BI s BI’s or the relevant BI Affiliate’s behalf. (c) Except as set forth above, Zealand Pharma shall not initiate any Paragraph IV Proceeding without the prior written consent of BI, which consent shall not be unreasonably delayed or denied.