Decision-Making; Dispute Resolution. (a) The Executive Steering Committee shall have a single chairperson who will (i) solicit agenda items from the other Executive Steering Committee members, coordinate and prepare the agenda (which shall include any agenda items reasonably proposed by Executive Steering Committee members from the other Party), provide the agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting and ensure the orderly conduct of the Executive Steering Committee’s meetings, (ii) attend (subject to the below) each meeting of the Executive Steering Committee, and (iii) prepare and issue minutes of each meeting (which shall accurately reflect the discussions and decisions of the Executive Steering Committee at such meeting) in accordance with Section 7.5. Such minutes from each Executive Steering Committee meeting shall not be finalized until the Executive Steering Committee members from the other Party have reviewed and confirmed the accuracy of [***] 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. such minutes as described in Section 7.5 and if not previously confirmed, such matter shall be the first order of business at the next Executive Steering Committee meeting. The Party appointing the chairperson shall alternate between Pfenex and Hospira every calendar year, and shall initially be designated by Hospira. In the event the chairperson or another representative of the Executive Steering Committee from either Party is unable to attend or participate in any meeting of the Executive Steering Committee, the Party who appointed such Executive Steering Committee chairperson or representative may appoint a substitute chairperson or other representative for that meeting. All decisions of the Executive Steering Committee and any Working Committee shall be made by consensus, with each Party having one (1) vote. Each Party shall work in good faith to reach consensus on matters and act in the general spirit of cooperation and in no event shall either Party unreasonably withhold, condition or delay any approval or other decision of the Executive Steering Committee or a Working Committee hereunder. In the event a Working Committee fails to reach consensus with respect to a particular matter within its authority, then upon request by either Party such matter shall be referred to the Executive Steering Committee for resolution. (b) If the Executive Steering Committee is unable to reach a decision as to any matter within its authority (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) Business Days, then either Pfenex or Hospira may provide written notice of such dispute to the Chief Executive Officer of the other Party and such matter shall be resolved as set forth below. The Chief Executive Officers (or their respective designees, who shall be senior officers of Pfenex and Hospira, but shall not be members of the Executive Steering Committee) of each of Pfenex and Hospira shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Officers or their designees within thirty (30) days after submission of such dispute to such officers, then: (i) except the Chief Executive Officer of Pfenex shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the Pfenex Technology including the Prosecution and Maintenance of the Pfenex Inventions and the enforcement thereof (except for matters that Hospira has the right to control pursuant to Section 6.6(c)); (ii) the General Counsel of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the IP Strategy and the matters related to the Hospira Technology including the Prosecution and Maintenance of the Hospira Inventions and the enforcement thereof; (iii) the Chief Commercial Officer of Hospira shall have the authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the commercialization of Product under this Agreement; (iv) the Chief Scientific Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, (A) all matters related to clinical protocol for the conduct of the Comparative Clinical Study, (B) all matters [***] 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. related to regulatory affairs (including with respect to communication to the FDA and the EMA) regarding Product and (C) subject to Section 3.2(b), all matters related to the Development Plan, the Development Program and Product Data Sheet; (v) the Senior Vice President of Operations of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to commercial scale manufacturing of Product; and (vi) the Chief Executive Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any other matter not previously addressed in clauses (i) through (v) above. Notwithstanding the foregoing, neither Party shall have any final decision-making authority with respect to matters described in Section 3.1(e), Section 7.1(i) or Section 7.1(j).
Appears in 3 contracts
Samples: Development and License Agreement, Development and License Agreement (Pfenex Inc.), Development and License Agreement (Pfenex Inc.)
Decision-Making; Dispute Resolution. (a) The Executive Steering Committee shall have a single chairperson who will shall (i) solicit agenda items from the other Executive Steering Committee members, coordinate and prepare the agenda (which shall include any agenda items reasonably proposed by Executive Steering Committee members from the other Party), provide the agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting and ensure the orderly conduct of the Executive Steering Committee’s meetings, (ii) attend (subject to the below) each meeting of the Executive Steering Committee, and (iii) prepare and issue minutes of each meeting (which shall accurately reflect the discussions and decisions of the Executive Steering Committee at such meeting) in accordance with Section 7.5. Such minutes from each Executive Steering Committee meeting shall not be finalized until the Executive Steering Committee members from the other Party have reviewed and confirmed the accuracy of [***] 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. such minutes as described in Section 7.5 and if not previously confirmed, such matter shall be the first order of business at the next Executive Steering Committee meeting. The Party appointing the chairperson shall alternate between Pfenex and Hospira Alvogen every calendar year, and shall initially be designated by HospiraAlvogen. In the event the chairperson or another representative member of the Executive Steering Committee from either Party is unable to attend or participate in any meeting of the Executive Steering Committee, the Party who appointed such Executive Steering Committee chairperson or representative member may appoint a substitute chairperson or other representative member for that meeting. All decisions of the Executive Steering Committee and any Working Committee shall be made by consensus, with each Party having one (1) vote. Each Party shall work in good faith to reach consensus on matters and act in the general spirit of cooperation and in no event shall either Party unreasonably withhold, condition or delay any approval or other decision of the Executive Steering Committee or a Working Committee hereunder. In the event a Working Committee fails to reach consensus with respect to a particular matter within its authority, then upon request by either Party such matter shall be referred to the Executive Steering Committee for resolution.
(b) If the Executive Steering Committee is unable to reach a decision as to any matter within its authority (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) Business Days, then either Pfenex or Hospira Alvogen may provide written notice of such dispute to the President or Chief Executive Officer of the other Party and such matter shall be resolved as set forth below. The Chief Executive Officers (or their respective designees, who shall be senior officers officer of Pfenex and Hospira[***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Alvogen, but shall not be members of the Executive Steering Committee) of each of Pfenex and Hospira Alvogen shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Officers or their designees within thirty (30) days after submission of such dispute to such officers, then:
(i) except the Chief Executive Officer of Pfenex shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all disputed matters related to (A) the Pfenex Technology including and the Prosecution and Maintenance of the Pfenex Patents claiming Product Inventions and the enforcement thereof (except for matters that Hospira Alvogen has the right to control pursuant to Section 6.6(c6.5(c));, (B) Pfenex’s responsibilities under the Development Plan and the conduct of the activities thereunder as described in Section 3.1, (C) the content of proposed publications or presentations under Section 8.8, and (D) the existence of Safety Reasons under either Section 10.2(a)(iii) or Section 10.2(b)(iii); and
(ii) the General Counsel Chief Executive Officer of Hospira Alvogen shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the IP Strategy and the matters related to the Hospira Technology including the Prosecution and Maintenance of the Hospira Inventions and the enforcement thereof;
(iii) the Chief Commercial Officer of Hospira shall have the authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the commercialization of Product under this Agreement;
(iv) the Chief Scientific Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, (A) all matters related to clinical protocol for the conduct of the Comparative Clinical StudyIP Strategy (other than as referenced in Section 7.4(b)(i)(A)), (B) all matters [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested regulatory affairs with respect to Product in the omitted portions. related to regulatory affairs Territory (including communications and filings with respect to communication to the FDA EMA and other Regulatory Agencies in the EMATerritory) regarding Product and (C) subject to Section 3.2(b), all matters related to the Development Plan, manufacture and Commercialization of Product in the Development Program and Product Data Sheet;
(v) the Senior Vice President of Operations of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to commercial scale manufacturing of Product; and
(vi) the Chief Executive Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any other matter not previously addressed in clauses (i) through (v) above. Notwithstanding the foregoing, neither Party shall have any final decision-making authority with respect to matters described in Section 3.1(e), Section 7.1(i) or Section 7.1(j)Territory.
Appears in 1 contract
Samples: e.u. Development and License Agreement (Pfenex Inc.)
Decision-Making; Dispute Resolution. (a) The Executive Steering Committee shall have a single chairperson who will shall (i) solicit agenda items from the other Executive Steering Committee members, coordinate and prepare the agenda (which shall include any agenda items reasonably proposed by Executive Steering Committee members from the other Party), provide the agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting and ensure the orderly conduct of the Executive Steering Committee’s meetings, (ii) attend (subject to the below) each meeting of the Executive Steering Committee, and (iii) prepare and issue minutes of each meeting (which shall accurately reflect the discussions and decisions of the Executive Steering Committee at such meeting) in accordance with Section Section 7.5. Such minutes from each Executive Steering Committee meeting shall not be finalized until the Executive Steering Committee members from the other Party have reviewed and confirmed the accuracy of [***] 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. such minutes as described in Section Section 7.5 and if not previously confirmed, such matter shall be the first order of business at the next Executive Steering Committee meeting. The Party appointing the chairperson shall alternate between Pfenex NRx and Hospira Alvogen every calendar year, and shall initially be designated by HospiraAlvogen. In the event the chairperson or another representative member of the Executive Steering Committee from either Party is unable to attend or participate in any meeting of the Executive Steering Committee, the Party who appointed such Executive Steering Committee chairperson or representative member may appoint a substitute chairperson or other representative member for that meeting. All decisions of the Executive Steering Committee and any Working Committee shall be made by consensus, with each Party having one (1) vote. Each Party shall work in good faith to reach consensus on matters and act in the general spirit of cooperation and in no event shall either Party unreasonably withhold, condition or delay any approval or other decision of the Executive Steering Committee or a Working Committee hereunder. In the event a Working Committee fails to reach consensus with respect to a particular matter within its authority, then upon request by either Party such matter shall be referred to the Executive Steering Committee for resolution.
(b) If the Executive Steering Committee is unable to reach a decision as to any matter within its authority (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) Business Days, then either Pfenex NRx or Hospira Alvogen may provide written notice of such dispute to the President or Chief Executive Officer of the other Party and such matter shall be resolved as set forth below. The Chief Executive Officers (or their respective designees, who shall be senior officers officer of Pfenex NRx and HospiraXxxxxxx, but shall not be members of the Executive Steering Committee) of each of Pfenex NRx and Hospira Xxxxxxx shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Officers or their designees within thirty (30) days after submission of such dispute to such officers, then:
(i) except the Chief Executive Officer of Pfenex NRx shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all disputed matters related to (A) the NRx Technology and the Prosecution and Maintenance of Patents claiming Product Inventions and the enforcement thereof (except for matters that Alvogen has the right to control pursuant to Section 6.5), (B) prior to the Milestone Payment, the content of proposed publications or presentations under Section 8.8, and (C) the existence of Safety Reasons under Section 10.2(a)(i)(2).
(ii) the Chief Executive Officer of Xxxxxxx shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the Pfenex Technology including the Prosecution and Maintenance of the Pfenex Inventions and the enforcement thereof (except for matters that Hospira has the right to control pursuant to Section 6.6(c));
(ii) the General Counsel of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the IP Strategy and the matters related to the Hospira Technology including the Prosecution and Maintenance of the Hospira Inventions and the enforcement thereof;
(iii) the Chief Commercial Officer of Hospira shall have the authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the commercialization of Product under this Agreement;
(iv) the Chief Scientific Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, (A) all matters related to clinical protocol for the conduct of the Comparative Clinical StudyIP Strategy (other than as referenced in Section 7.4(b)(i)(A)), (B) all matters [***] Certain information in this document has been omitted after the Milestone Payment, the content of proposed publications or presentations under Section 8.8, (C) regulatory affairs, strategies and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested activities with respect to Product in the omitted portions. related to regulatory affairs Territory (including communications and filings with respect to communication to the FDA and the EMA) regarding Product content of the NDA and (C) subject to Section 3.2(bother Regulatory Materials)), all matters related to (D) the Development Plan, and the Development Program conduct of development and Product Data Sheet;
(v) the Senior Vice President of Operations of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to commercial scale manufacturing of Product; and
(vi) the Chief Executive Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any other matter not previously addressed in clauses (i) through (v) above. Notwithstanding the foregoing, neither Party shall have any final decision-making authority regulatory activities with respect to matters described Product in Section 3.1(e)the Territory, Section 7.1(i(D) the manufacture and Commercialization of Product in the Territory, and (F) the existence of Safety Reasons under or Section 7.1(jSection 10.2(b)(iii).
Appears in 1 contract
Samples: Exclusive, Global Development, Supply, Marketing & License Agreement (NRX Pharmaceuticals, Inc.)
Decision-Making; Dispute Resolution. (a) The Executive Steering Committee shall have a single chairperson who will shall (i) solicit agenda items from the other Executive Steering Committee members, coordinate and prepare the agenda (which shall include any agenda items reasonably proposed by Executive Steering Committee members from the other Party), provide the agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting and ensure the orderly conduct of the Executive Steering Committee’s meetings, (ii) attend (subject to the below) each meeting of the Executive Steering Committee, and (iii) prepare and issue minutes of each meeting (which shall accurately reflect the discussions and decisions of the Executive Steering Committee at such meeting) in accordance with Section 7.5. Such minutes from each Executive Steering Committee meeting shall not be finalized until the Executive Steering Committee members from the other Party have reviewed and confirmed the accuracy of [***] 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. such minutes as described in Section 7.5 and if not previously confirmed, such matter shall be the first order of business at the next Executive Steering Committee meeting. The Party appointing the chairperson shall alternate between Pfenex and Hospira Alvogen every calendar year, and shall initially be designated by HospiraAlvogen. In the event the chairperson or another representative member of the Executive Steering Committee from either Party is unable to attend or participate in any meeting of the Executive Steering Committee, the Party who appointed such Executive Steering Committee chairperson or representative member may appoint a substitute chairperson or other representative member for that meeting. All decisions of the Executive Steering Committee and any Working Committee shall be made by consensus, with each Party having one (1) vote. Each Party shall work in good faith to reach consensus on matters and act in the general spirit of cooperation and in no event shall either Party unreasonably withhold, condition or delay any approval or other decision of the Executive Steering Committee or a Working Committee hereunder. In the event a Working Committee fails to reach consensus with [***] 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. respect to a particular matter within its authority, then upon request by either Party such matter shall be referred to the Executive Steering Committee for resolution.
(b) If the Executive Steering Committee is unable to reach a decision as to any matter within its authority (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) Business Days, then either Pfenex or Hospira Alvogen may provide written notice of such dispute to the President or Chief Executive Officer of the other Party and such matter shall be resolved as set forth below. The Chief Executive Officers (or their respective designees, who shall be senior officers officer of Pfenex and HospiraAlvogen, but shall not be members of the Executive Steering Committee) of each of Pfenex and Hospira Alvogen shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Officers or their designees within thirty (30) days after submission of such dispute to such officers, then:
(i) except the Chief Executive Officer of Pfenex shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all disputed matters related to (A) the Pfenex Technology including and the Prosecution and Maintenance of the Pfenex Patents claiming Product Inventions and the enforcement thereof (except for matters that Hospira Alvogen has the right to control pursuant to Section 6.6(c6.5(c));, (B) communications with the FDA and the content of the NDA and other Regulatory Materials (up and through the date of the Transfer Notice), (C) the Development Plan prior to the Transfer Notice and the conduct of the activities thereunder as described in Section 3.1(a), (D) the content of proposed publications or presentations under Section 8.8, (E) the COGs Reduction Plan or the implementation thereof under Section 5.2(a) and (F) the existence of Safety Reasons under either Section 10.2(a)(iii) or Section 10.2(b)(iii); and
(ii) the General Counsel Chief Executive Officer of Hospira Alvogen shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the IP Strategy and the matters related to the Hospira Technology including the Prosecution and Maintenance of the Hospira Inventions and the enforcement thereof;
(iii) the Chief Commercial Officer of Hospira shall have the authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the commercialization of Product under this Agreement;
(iv) the Chief Scientific Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, (A) all matters related to clinical protocol for the conduct of the Comparative Clinical StudyIP Strategy (other than as referenced in Section 7.4(b)(i)(A)), (B) all matters [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested regulatory affairs with respect to Product in the omitted portions. related to regulatory affairs Territory (including communications and filings with respect to communication to the FDA and FDA) (only after the EMATransfer Notice as referenced in Section 7.4(b)(i)(B)) regarding Product and (C) subject to Section 3.2(b), all matters related to the Development Plan, manufacture and Commercialization of Product in the Development Program and Product Data Sheet;
(v) the Senior Vice President of Operations of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to commercial scale manufacturing of Product; and
(vi) the Chief Executive Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any other matter not previously addressed in clauses (i) through (v) above. Notwithstanding the foregoing, neither Party shall have any final decision-making authority with respect to matters described in Section 3.1(e), Section 7.1(i) or Section 7.1(j)Territory.
Appears in 1 contract
Decision-Making; Dispute Resolution. (a) The Executive Steering Committee shall have a single chairperson who will (i) solicit agenda items from the other Executive Steering Committee members, coordinate and prepare the agenda (which shall include any agenda items reasonably proposed by Executive Steering Committee members from the other Party), provide the agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting and ensure the orderly conduct of the Executive Steering Committee’s meetings, (ii) attend (subject to the below) each meeting of the Executive Steering Committee, and (iii) prepare and issue minutes of each meeting (which shall accurately reflect the discussions and decisions of the Executive Steering Committee at such meeting) in accordance with Section 7.5. Such minutes from each Executive Steering Committee meeting shall not be finalized until the Executive Steering Committee members from the other Party have reviewed and confirmed the accuracy of [***] 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. such minutes as described in Section 7.5 and if not previously confirmed, such matter shall be the first order of business at the next Executive Steering Committee meeting. The Party appointing customary duties; the chairperson shall alternate between Pfenex Alvotech and Hospira Alvogen every calendar yeartwelve (12) months, and shall initially be designated by Hospira. In the event the chairperson or another representative of the Executive Steering Committee from either Party is unable to attend or participate in any meeting of the Executive Steering Committee, the Party who appointed such Executive Steering Committee chairperson or representative may appoint a substitute chairperson or other representative for that meetingAlvogen. All decisions of the Executive Steering Committee and any Working Committee shall be made by consensus, with each Party having one (1) vote. Each Party shall work in good faith to reach consensus on matters unanimous vote and act the highest-ranking executive attending or participating in the general spirit meeting of cooperation each of Alvotech and in no event Alvogen on the Executive Steering Committee shall either Party unreasonably withhold, condition or delay have the right to vote on behalf of any approval or other decision members of the Executive Steering Committee from such Party not attending or a Working Committee hereunder. In participating in the event a Working Committee fails to reach consensus with respect to a particular matter within its authority, then upon request by either Party such matter shall be referred to the Executive Steering Committee for resolutionmeeting.
(b) If the members of the Executive Steering Committee is are unable to reach a unanimous decision as to any matter within its authority (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) Business Daysdays, then then, except in relation to disputes relating to commercialisation matters that will be dealt with in accordance with the remaining provisions of this Section, either Pfenex Alvotech or Hospira Alvogen may provide written notice of such dispute to the Chief Executive Officer of the other Party and Party. If such matter shall be resolved as set forth below. The dispute relates to a commercialization matter, then the Chief Executive Commercialization Officers (or their respective designees, who shall be senior officers of Pfenex and Hospira, but shall not be members of the Executive Steering Committee) of each of Pfenex Alvotech and Hospira Alvogen shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If such dispute relates to any other matter, then the Chief Executive Officers (or their respective designees, who shall not be members of the Executive Steering Committee) of each of Alvotech and Alvogen shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Commercialization Officers or their designees within thirty (30) days after submission of such dispute to such officers, then:
then (i) except the Chief Executive Officer of Pfenex shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the Pfenex Technology including the Prosecution and Maintenance of the Pfenex Inventions and the enforcement thereof (except for matters that Hospira has the right to control pursuant to Section 6.6(c));
(ii) the General Counsel of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the IP Strategy and the matters related to the Hospira Technology including the Prosecution and Maintenance of the Hospira Inventions and the enforcement thereof;
(iii) the Chief Commercial Officer of Hospira shall have the authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the commercialization of Product under this Agreement;
(iv) the Chief Scientific Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, (A) all matters related to clinical protocol for the conduct of the Comparative Clinical Study, (B) all matters [***] 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. related to regulatory affairs (including with respect to communication to the FDA and the EMA) regarding Product and (C) subject to Section 3.2(b), all matters related to the Development Plan, the Development Program and Product Data Sheet;
(v) the Senior Vice President of Operations of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to commercial scale manufacturing of Product; and
(via) the Chief Executive Officer of Hospira Alvogen shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any other matter not previously addressed dispute related to the commercialization of the Products in clauses the Alvogen Territories, (b) the Chairman of Alvotech shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any dispute related to (i) through platform technology related to manufacturing and development, (vii) abovemanufacturing of the Products, including any increase or decrease in the Manufacturing Cost submitted for approval to the Executive Steering Committee in accordance with Section 5.6, (iii) chemistry, manufacturing and controls or (iv) intellectual property matters in any Territory (other than with respect to the Alvogen Marks or the Product Marks) and (c) the Chief Scientific Officer of Alvotech shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any dispute related to regulatory affairs with respect to the Alvogen Territories. In the event Alvotech does not have a Chief Scientific Officer at the time of any such dispute, the reference to Chief Scientific Officer shall at such time mean Alvotech’s senior executive officer exercising the authority customary for the office of Chief Scientific Officer. If any dispute subject to this Section 9.4(b) is not resolved in accordance with the procedures set out in this Section 9.4(b), then such dispute shall be resolved in accordance with Section 14.5. Notwithstanding the foregoing, neither Party if the dispute concerns the interpretation of this Agreement, the performance or alleged non-performance of a Party’s obligations under this Agreement, or any other breach or alleged breach of this Agreement, such matters shall have any final decision-making authority be resolved in accordance with respect to matters described in Section 3.1(e), 14.4 and Section 7.1(i) or Section 7.1(j)14.5 of this Agreement.
Appears in 1 contract
Samples: Product Rights Agreement (Alvotech Lux Holdings S.A.S.)
Decision-Making; Dispute Resolution. (a) The Executive Steering Committee shall have a single chairperson who will shall (i) solicit agenda items from the other Executive Steering Committee members, coordinate and prepare the agenda (which shall include any agenda items reasonably proposed by Executive Steering Committee members from the other Party), provide the agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting and ensure the orderly conduct of the Executive Steering Committee’s meetings, (ii) attend (subject to the below) each meeting of the Executive Steering Committee, and (iii) prepare and issue minutes of each meeting (which shall accurately reflect the discussions and decisions of the Executive Steering Committee at such meeting) in accordance with Section 7.5. Such minutes from each Executive Steering Committee meeting shall not be finalized until the Executive Steering Committee members from the other Party have reviewed and confirmed the accuracy of [***] 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. such minutes as described in Section 7.5 and if not previously confirmed, such matter shall be the first order of business at the next Executive Steering Committee meeting. The Party appointing the chairperson shall alternate between Pfenex and Hospira Alvogen every calendar year, and shall initially be designated by HospiraAlvogen. In the event the chairperson or another representative member of the Executive Steering Committee from either Party is unable to attend or participate in any meeting of the Executive Steering Committee, the Party who appointed such Executive Steering Committee chairperson or representative member may appoint a substitute chairperson or other representative member for that meeting. All decisions of the Executive Steering Committee and any Working Committee shall be made by consensus, with each Party having one (1) vote. Each Party shall work in good faith to reach consensus on matters and act in the general spirit of cooperation and in no event shall either Party unreasonably withhold, condition or delay any approval or other decision of the Executive Steering Committee or a Working Committee hereunder. In the event a Working Committee fails to reach consensus with respect to a particular matter within its authority, then upon request by either Party such matter shall be referred to the Executive Steering Committee for resolution. [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
(b) If the Executive Steering Committee is unable to reach a decision as to any matter within its authority (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) Business Days, then either Pfenex or Hospira Alvogen may provide written notice of such dispute to the President or Chief Executive Officer of the other Party and such matter shall be resolved as set forth below. The Chief Executive Officers (or their respective designees, who shall be senior officers officer of Pfenex and HospiraAlvogen, but shall not be members of the Executive Steering Committee) of each of Pfenex and Hospira Alvogen shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Officers or their designees within thirty (30) days after submission of such dispute to such officers, then:
(i) except the Chief Executive Officer of Pfenex shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all disputed matters related to (A) the Pfenex Technology including and the Prosecution and Maintenance of the Pfenex Patents claiming Product Inventions and the enforcement thereof (except for matters that Hospira Alvogen has the right to control pursuant to Section 6.6(c6.5(c));, (B) Pfenex’s responsibilities under the Development Plan and the conduct of the activities thereunder as described in Section 3.1, (C) the content of proposed publications or presentations under Section 8.7, and (D) the existence of Safety Reasons under Section 10.2(a)(iii); and
(ii) the General Counsel Chief Executive Officer of Hospira Alvogen shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the IP Strategy and the matters related to the Hospira Technology including the Prosecution and Maintenance of the Hospira Inventions and the enforcement thereof;
(iii) the Chief Commercial Officer of Hospira shall have the authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the commercialization of Product under this Agreement;
(iv) the Chief Scientific Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, (A) all matters related to clinical protocol for the conduct of the Comparative Clinical StudyIP Strategy (other than as referenced in Section 7.4(b)(i)(A)), (B) all matters [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested regulatory affairs with respect to Product in the omitted portions. related to regulatory affairs Territory (including communications and filings with respect to communication to the FDA and Regulatory Agencies in the EMATerritory) regarding Product and (C) subject to Section 3.2(b)the manufacture and Commercialization of Product in the Territory, all matters related to the Development Plan, the Development Program and Product Data Sheet;
(vD) the Senior Vice President existence of Operations of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to commercial scale manufacturing of Product; and
(vi) the Chief Executive Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any other matter not previously addressed in clauses (i) through (v) above. Notwithstanding the foregoing, neither Party shall have any final decision-making authority with respect to matters described in Safety Reason under Section 3.1(e), Section 7.1(i) or Section 7.1(j10.2(b)(iii).
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Decision-Making; Dispute Resolution. (a) The Executive Steering Committee shall have a single chairperson who will shall (i) solicit agenda items from the other Executive Steering Committee members, coordinate and prepare the agenda (which shall include any agenda items reasonably proposed by Executive Steering Committee members from the other Party), provide the agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting and ensure the orderly conduct of the Executive Steering Committee’s meetings, (ii) attend (subject to the below) each meeting of the Executive Steering Committee, and (iii) prepare and issue minutes of each meeting (which shall accurately reflect the discussions and decisions of the Executive Steering Committee at such meeting) in accordance with Section 7.5. Such minutes from each Executive Steering Committee meeting shall not be finalized until the Executive Steering Committee members from the other Party have reviewed and confirmed the accuracy of [***] 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. such minutes as described in Section 7.5 and if not previously confirmed, such matter shall be the first order of business at the next Executive Steering Committee meeting. The Party appointing the chairperson shall alternate between Pfenex and Hospira Alvogen every calendar year, and shall initially be designated by HospiraAlvogen. In the event the chairperson or another representative member of the Executive Steering Committee from either Party is unable to attend or participate in any meeting of the Executive Steering Committee, the Party who appointed such Executive Steering Committee chairperson or representative member may appoint a substitute chairperson or other representative member for that meeting. All decisions of the Executive Steering Committee and any Working Committee shall be made by consensus, with [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. each Party having one (1) vote. Each Party shall work in good faith to reach consensus on matters and act in the general spirit of cooperation and in no event shall either Party unreasonably withhold, condition or delay any approval or other decision of the Executive Steering Committee or a Working Committee hereunder. In the event a Working Committee fails to reach consensus with respect to a particular matter within its authority, then upon request by either Party such matter shall be referred to the Executive Steering Committee for resolution.
(b) If the Executive Steering Committee is unable to reach a decision as to any matter within its authority (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) Business Days, then either Pfenex or Hospira Alvogen may provide written notice of such dispute to the President or Chief Executive Officer of the other Party and such matter shall be resolved as set forth below. The Chief Executive Officers (or their respective designees, who shall be senior officers officer of Pfenex and HospiraAlvogen, but shall not be members of the Executive Steering Committee) of each of Pfenex and Hospira Alvogen shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Officers or their designees within thirty (30) days after submission of such dispute to such officers, then:
(i) except the Chief Executive Officer of Pfenex shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all disputed matters related to (A) the Pfenex Technology including and the Prosecution and Maintenance of the Pfenex Patents claiming Product Inventions and the enforcement thereof (except for matters that Hospira Alvogen has the right to control pursuant to Section 6.6(c6.5(c));, (B) Pfenex’s responsibilities under the Development Plan and the conduct of the activities thereunder as described in Section 3.1, (C) the content of proposed publications or presentations under Section 8.8, and (D) the existence of Safety Reasons under either Section 10.2(a)(iii) or Section 10.2(b)(iii); and
(ii) the General Counsel Chief Executive Officer of Hospira Alvogen shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the IP Strategy and the matters related to the Hospira Technology including the Prosecution and Maintenance of the Hospira Inventions and the enforcement thereof;
(iii) the Chief Commercial Officer of Hospira shall have the authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the commercialization of Product under this Agreement;
(iv) the Chief Scientific Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, (A) all matters related to clinical protocol for the conduct of the Comparative Clinical StudyIP Strategy (other than as referenced in Section 7.4(b)(i)(A)), (B) all matters [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested regulatory affairs with respect to Product in the omitted portions. related to regulatory affairs Territory (including communications and filings with respect to communication to the FDA and Regulatory Agencies in the EMATerritory) regarding Product and (C) subject to Section 3.2(b), all matters related to the Development Plan, manufacture and Commercialization of Product in the Development Program and Product Data Sheet;
(v) the Senior Vice President of Operations of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to commercial scale manufacturing of Product; and
(vi) the Chief Executive Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, any other matter not previously addressed in clauses (i) through (v) above. Notwithstanding the foregoing, neither Party shall have any final decision-making authority with respect to matters described in Section 3.1(e), Section 7.1(i) or Section 7.1(j)Territory.
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Samples: Mena Development and License Agreement (Pfenex Inc.)
Decision-Making; Dispute Resolution. (a) The Executive Steering Committee shall have a single chairperson who will shall (i) solicit agenda items from the other Executive Steering Committee members, [***] 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. coordinate and prepare the agenda (which shall include any agenda items reasonably proposed by Executive Steering Committee members from the other Party), provide the agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting and ensure the orderly conduct of the Executive Steering Committee’s meetings, (ii) attend (subject to the below) each meeting of the Executive Steering Committee, and (iii) prepare and issue minutes of each meeting (which shall accurately reflect the discussions and decisions of the Executive Steering Committee at such meeting) in accordance with Section 7.5. Such minutes from each Executive Steering Committee meeting shall not be finalized until the Executive Steering Committee members from the other Party have reviewed and confirmed the accuracy of [***] 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. such minutes as described in Section 7.5 and if not previously confirmed, such matter shall be the first order of business at the next Executive Steering Committee meeting. The Party appointing the chairperson shall alternate between Pfenex and Hospira NT Pharma every calendar year, and shall initially be designated by HospiraPfenex. In the event the chairperson or another representative of the Executive Steering Committee from either Party is unable to attend or participate in any meeting of the Executive Steering Committee, the Party who appointed such Executive Steering Committee chairperson or representative may appoint a substitute chairperson or other representative for that meeting. All decisions of the Executive Steering Committee and any Working Committee shall be made by consensus, with each Party having one (1) vote. Each Party shall work in good faith to reach consensus on matters and act in the general spirit of cooperation and in no event shall either Party unreasonably withhold, condition or delay any approval or other decision of the Executive Steering Committee or a Working Committee hereunder. In the event a Working Committee fails to reach consensus with respect to a particular matter within its authority, then upon request by either Party such matter shall be referred to the Executive Steering Committee for resolution.
(b) If the Executive Steering Committee is unable to reach a decision as to any matter within its authority (including any matter expressly required to be resolved by the Executive Steering Committee pursuant to this Agreement) after a period of ten (10) Business Days, then either Pfenex or Hospira NT Pharma may provide written notice of such dispute to the Chief Executive Officer of the other Party and such matter shall be resolved as set forth below. The Chief Executive Officers (or their respective designees, who shall be senior officers officer of Pfenex and HospiraNT Pharma, but shall not be members of the Executive Steering Committee) of each of Pfenex and Hospira NT Pharma shall discuss the dispute in person or telephonically and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to such officers. If any such dispute is not resolved by the Chief Executive Officers or their designees within thirty (30) days after submission of such dispute to such officers, then:
(i) except the Chief Executive Officer of Pfenex shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to (A) the Pfenex Technology, the Pfenex Expression Technology including and the Prosecution and Maintenance of the Pfenex Patents claiming Inventions and the enforcement thereof (except for matters that Hospira NT Pharma has the right to control pursuant to Section 6.6(c6.5(c));
(ii) the General Counsel of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the IP Strategy and the matters related to the Hospira Technology including the Prosecution and Maintenance of the Hospira Inventions and the enforcement thereof;
(iii) the Chief Commercial Officer of Hospira shall have the authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to the commercialization of Product under this Agreement;
(iv) the Chief Scientific Officer of Hospira shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, (A) all matters related to clinical protocol for the conduct of the Comparative Clinical Study, (B) all matters information supporting or referenced in the CMC Section with respect to Product, (C) the manufacture of Product for development or commercialization purposes, (D) the content of proposed publications or presentations under Section 8.6 and (E) the existence of Safety Reasons under Section 10.2(a)(iv) and Section 10.2(b)(iii). [***] 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. related to regulatory affairs (including with respect to communication to the FDA and the EMA) regarding Product and (C) subject to Section 3.2(b), all matters related to the Development Plan, the Development Program and Product Data Sheet;.
(vii) the Senior Vice President Chief Executive Officer of Operations of Hospira NT Pharma shall have authority to finally resolve, in such officer’s reasonable discretion exercised in good faith, all matters related to commercial scale manufacturing of Product; and
(viA) IP Strategy (other than as referenced in Section 7.4(b)(i)(A)), (B) regulatory affairs with respect to Product in the Territory (including communications with Regulatory Agencies in the Territory), (C) the Chief Executive Officer marketing, promotion, sale and distribution of Hospira shall have authority Product in the Territory, and (D) the protocol for any preclinical or human clinical study with respect to finally resolve, Product in such officer’s reasonable discretion exercised in good faith, any other matter not previously addressed in clauses (i) through (v) abovethe Territory. Notwithstanding the foregoing, neither Party shall have any final decision-making authority with respect to matters described in Section 3.1(e)7.1, Section 7.1(i) or Section 7.1(j)other than IP Strategy.
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