Common use of Coordination; Assistance; Subcontracting Clause in Contracts

Coordination; Assistance; Subcontracting. (a) The Party responsible for conducting a particular activity pursuant to this Article III (with respect to such activity, the “Responsible Party”) shall keep the other Party (the “Other Party”) reasonably informed as to the Responsible Party’s (and its Affiliates’) planned activities (including written plans with estimated timelines) and progress with respect to such activities (individually and collectively, the “Article III Activities”) through quarterly updates to the Executive Steering Committee. (b) The Other Party shall cooperate and provide the Responsible Party with reasonable assistance in connection with the performance by the Responsible Party of its Article III Activities. (c) The Responsible Party may subcontract to Affiliates or Third Parties (each, a “Subcontractor”) any portion of its responsibilities with respect to development of Product in the Territory. Each Subcontractor shall enter into a written agreement with the Responsible Party pursuant to which such Subcontractor shall (i) be bound by obligations of confidentiality and non-use with respect to the Confidential Information of the Other Party or otherwise relating to Product at least as protective as the obligations set forth in Section 8.1 through Section 8.3, (ii) be bound by obligations with respect to Intellectual Property sufficient to enable the Responsible Party to comply with the terms and conditions of this Agreement as if the Responsible Party completed any such subcontracted Article III Activity itself, (iii) be required to make representations and [***]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. warranties with respect to debarment comparable to the representations and warranties made by the Responsible Party under Section 9.2(g), (iv) be obligated to provide notice to the Responsible Party upon becoming the subject of any investigation or debarment proceeding that could lead to such Subcontractor becoming a Debarred Entity or Debarred Individual, and (v) be required to comply with all Applicable Laws, including, if applicable, cGxP. The Responsible Party shall supervise and be responsible under this Agreement for the work of any such Subcontractor. No subcontracting of any obligation or activity under this Agreement shall relieve the Responsible Party of any of its obligations or responsibilities under this Agreement. (d) The Responsible Party shall, and shall cause each Subcontractor engaged pursuant to Section 3.3(c) to, maintain complete and accurate books and records, in sufficient detail (and in good scientific manner appropriate for patent and regulatory purposes, when applicable, and in compliance with all Applicable Laws) and for purposes of demonstrating compliance with the terms hereof, that fully and properly reflect all work done and results achieved with respect to development of Product in the Territory (the “Product Records”). The Responsible Party shall retain all Product Records for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of the Other Party, the Product Records shall be subject to inspection and audit by and at the expense of the Other Party no more than two times in any Annual Period. Such audits shall occur upon reasonable notice and during normal business hours by an independent auditor selected by the Other Party and reasonably acceptable to the Responsible Party. The Other Party shall treat all information received or subject to review under this Section 3.3(d) as Confidential Information of the Responsible Party in accordance with the provisions of Article VIII. The Other Party shall cause its independent auditor to enter into a confidentiality agreement, in form and substance reasonably acceptable to the Responsible Party, to maintain such records and information of the Responsible Party in confidence in accordance with Article VIII and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof. (e) The Parties shall enter into one or more safety exchange or pharmaco-vigilance agreements (each, a “PV Agreement”) on reasonable and customary terms to ensure compliance with safety reporting requirements of all applicable Regulatory Agencies globally (including in connection with maintaining the MAA Approval and any Regulatory Approval for Product in the Territory) by providing detailed procedures regarding the collection, exchange and management of safety data relating to Product, including but not limited to the establishment and maintenance of a global safety database (which database shall be maintained by Alvogen), Adverse Drug Responses collection and reporting, and maintenance of core safety information. Pfenex (itself, its Affiliates and licensees) shall have reasonable access to such database and the data therein, including the right to query such data to determine and report safety signals.

Coordination; Assistance; Subcontracting. (a) The Party responsible for conducting a particular activity pursuant to this Article ‎ARTICLE III (with respect to such activity, the “Responsible Party”) shall keep the other Party (the “Other Party”) reasonably informed as to the Responsible Party’s (and its Affiliates’) planned activities (including written plans with estimated timelines) and progress with respect to such activities (individually and collectively, the “Article III Activities”) through quarterly updates to the Executive Steering Committee. (b) The Other Party shall cooperate and provide the Responsible Party with reasonable assistance in connection with the performance by the Responsible Party of its Article III Activities. (c) The Responsible Party may subcontract to Affiliates or Third Parties (each, a “Subcontractor”) any portion of its responsibilities with respect to development of Product in the Territory. Each Subcontractor shall enter into a written agreement with the Responsible Party pursuant to which such Subcontractor shall (i) be bound by obligations of confidentiality and non-use with respect to the Confidential Information of the Other Party or otherwise relating to Product at least as protective as the obligations set forth in Section ‎Section 8.1 through Section ‎Section 8.3, (ii) be bound by obligations with respect to Intellectual Property sufficient to enable the Responsible Party to comply with the terms and conditions of this Agreement as if the Responsible Party completed any such subcontracted Article III Activity itself, (iii) be required to make representations and [***]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. warranties with respect to debarment comparable to the representations and warranties made by the Responsible Party under Section ‎Section 9.2(g), (iv) be obligated to provide notice to the Responsible Party upon becoming the subject of any investigation or debarment proceeding that could lead to such Subcontractor becoming a Debarred Entity or Debarred Individual, and (v) be required to comply with all Applicable Laws, including, if applicable, cGxP. The Responsible Party shall supervise and be responsible under this Agreement for the work of any such Subcontractor. No subcontracting of any obligation or activity under this Agreement shall relieve the Responsible Party of any of its obligations or responsibilities under this Agreement. (d) The Responsible Party shall, and shall cause each Subcontractor engaged pursuant to Section ‎Section 3.3(c) to, maintain complete and accurate books and records, in sufficient detail (and in good scientific manner appropriate for patent and regulatory purposes, when applicable, and in compliance with all Applicable Laws) and for purposes of demonstrating compliance with the terms hereof, that fully and properly reflect all work done and results achieved with respect to development of Product in the Territory (the “Product Records”). The Responsible Party shall retain all Product Records for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of the Other Party, the Product Records shall be subject to inspection and audit by and at the expense of the Other Party no more than two times in any Annual Period. Such audits shall occur upon reasonable notice and during normal business hours by an independent auditor selected by the Other Party and reasonably acceptable to the Responsible Party. The Other Party shall treat all information received or subject to review under this Section ‎Section 3.3(d) as Confidential Information of the Responsible Party in accordance with the provisions of Article ‎ARTICLE VIII. The Other Party shall cause its independent auditor to enter into a confidentiality agreement, in form and substance reasonably acceptable to the Responsible Party, to maintain such records and information of the Responsible Party in confidence in accordance with Article ‎ARTICLE VIII and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof. (e) The Parties shall enter into one or more safety exchange or pharmaco-vigilance agreements (each, a “PV Agreement”) on reasonable and customary terms to ensure compliance with safety reporting requirements of all applicable Regulatory Agencies globally (including in connection with maintaining the MAA Approval and any Regulatory NDA Approval for Product in the TerritoryProduct) by providing detailed procedures regarding the collection, exchange and management of safety data relating to Product, including but not limited to the establishment and maintenance of a global safety database (which database shall be maintained by Alvogen), Adverse Drug Responses collection and reporting, and maintenance of core safety information. Pfenex (itself, its Affiliates and licensees) shall NRx will not have reasonable direct access to the global safety database for the Products in the Territory; provided that, Alvogen shall share safety data with NRx periodically (at least every Quarterly Period) and Alvogen will provide to NRx such information from the safety database as NRx may reasonably require to satisfy NRx’s obligations under Applicable Laws. The PV Agreement will set forth each Party’s responsibilities and obligations pertaining to safety data exchange procedures governing the data thereinexchange of information affecting the Products (e.g., including adverse events, Serious Adverse Events, emerging safety issues) to enable each Party to comply with all Applicable Laws related to the right to query such data to determine and report safety signalsProducts. The allocation of responsibilities between the Parties will be governed by the PV Agreement.

Coordination; Assistance; Subcontracting. (a) The Party responsible for conducting a particular activity pursuant to this Article III (with respect to such activity, the “Responsible Party”) shall keep the other Party (the “Other Party”) reasonably informed as to the Responsible Party’s (and its Affiliates’) planned activities (including written plans with estimated timelines) and progress with respect to such activities (individually and collectively, the “Article III Activities”) through quarterly updates to the Executive Steering Committee. (b) The Other Party shall cooperate and provide the Responsible Party with reasonable assistance in connection with the performance by the Responsible Party of its Article III Activities. (c) The Responsible Party may subcontract to Affiliates or Third Parties (each, a “Subcontractor”) any portion of its responsibilities with respect to development of Product in the Territory. Each Subcontractor shall enter into a written agreement with the Responsible Party pursuant to which such Subcontractor shall (i) be bound by obligations of confidentiality and non-use with respect to the Confidential Information of the Other Party or otherwise relating to Product at least as protective as the obligations set forth in Section 8.1 through Section 8.3, (ii) be bound by obligations with respect to Intellectual Property sufficient to enable the Responsible Party to comply with the terms and conditions of this Agreement as if the Responsible Party completed any such subcontracted Article III Activity itself, (iii) be required to make representations and [***]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. warranties with respect to debarment comparable to the representations and warranties made by the Responsible Party under Section 9.2(g), (iv) be obligated to provide notice to the Responsible Party upon becoming the subject of any investigation or debarment proceeding that could lead to [***]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. such Subcontractor becoming a Debarred Entity or Debarred Individual, and (v) be required to comply with all Applicable Laws, including, if applicable, cGxP. The Responsible Party shall supervise and be responsible under this Agreement for the work of any such Subcontractor. No subcontracting of any obligation or activity under this Agreement shall relieve the Responsible Party of any of its obligations or responsibilities under this Agreement. (d) The Responsible Party shall, and shall cause each Subcontractor engaged pursuant to Section 3.3(c) to, maintain complete and accurate books and records, in sufficient detail (and in good scientific manner appropriate for patent and regulatory purposes, when applicable, and in compliance with all Applicable Laws) and for purposes of demonstrating compliance with the terms hereof, that fully and properly reflect all work done and results achieved with respect to development of Product in the Territory (the “Product Records”). The Responsible Party shall retain all Product Records for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of the Other Party, the Product Records shall be subject to inspection and audit by and at the expense of the Other Party no more than two times in any Annual Period. Such audits shall occur upon reasonable notice and during normal business hours by an independent auditor selected by the Other Party and reasonably acceptable to the Responsible Party. The Other Party shall treat all information received or subject to review under this Section 3.3(d) as Confidential Information of the Responsible Party in accordance with the provisions of Article VIII. The Other Party shall cause its independent auditor to enter into a confidentiality agreement, in form and substance reasonably acceptable to the Responsible Party, to maintain such records and information of the Responsible Party in confidence in accordance with Article VIII and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof. (e) The Parties shall enter into one or more safety exchange or pharmaco-vigilance agreements (each, a “PV Agreement”) on reasonable and customary terms to ensure compliance with safety reporting requirements of all applicable Regulatory Agencies globally (including in connection with maintaining the MAA Approval and any Regulatory Approval for Product in the Territory) by providing detailed procedures regarding the collection, exchange and management of safety data relating to Product, including but not limited to the establishment and maintenance of a global safety database (which database shall be maintained by Alvogen), Adverse Drug Responses collection and reporting, and maintenance of core safety information. Pfenex (itself, its Affiliates and licensees) shall have reasonable access to such database and the data therein, including the right to query such data to determine and report safety signals.

Coordination; Assistance; Subcontracting. (a) The Party responsible for conducting a particular activity pursuant to this Article III (with respect to such activity, the “Responsible Party”) shall keep the other Party (the “Other Party”) reasonably informed as to the Responsible Party’s (and its Affiliates’) planned activities (including written plans with estimated timelines) and progress with respect to such activities (individually and collectively, the “Article III Activities”) through quarterly updates to the Executive Steering Committee. (b) The Other Party shall cooperate and provide the Responsible Party with reasonable assistance in connection with the performance by the Responsible Party of its Article III Activities. (c) The Responsible Party may subcontract to Affiliates or Third Parties (each, a “Subcontractor”) any portion of its responsibilities with respect to development of Product in the Territory. Each Subcontractor shall enter into a written agreement with the Responsible Party pursuant to which such Subcontractor shall (i) be bound by obligations of confidentiality and non-use with respect to the Confidential Information of the Other Party or otherwise relating to Product at least as protective as the obligations set forth in Section 8.1 through Section 8.3, (ii) be bound by obligations with respect to Intellectual Property sufficient to enable the Responsible Party to comply with the terms and conditions of this Agreement as if the Responsible Party completed any such subcontracted Article III Activity itself, (iii) be required to make representations and [***]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. warranties with respect to debarment comparable to the [***] 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. representations and warranties made by the Responsible Party under Section 9.2(g), (iv) be obligated to provide notice to the Responsible Party upon becoming the subject of any investigation or debarment proceeding that could lead to such Subcontractor becoming a Debarred Entity or Debarred Individual, and (v) be required to comply with all Applicable Laws, including, if applicable, cGxP. The Responsible Party shall supervise and be responsible under this Agreement for the work of any such Subcontractor. No subcontracting of any obligation or activity under this Agreement shall relieve the Responsible Party of any of its obligations or responsibilities under this Agreement. (d) The Responsible Party shall, and shall cause each Subcontractor engaged pursuant to Section 3.3(c) to, maintain complete and accurate books and records, in sufficient detail (and in good scientific manner appropriate for patent and regulatory purposes, when applicable, and in compliance with all Applicable Laws) and for purposes of demonstrating compliance with the terms hereof, that fully and properly reflect all work done and results achieved with respect to development of Product in the Territory (the “Product Records”). The Responsible Party shall retain all Product Records for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of the Other Party, the Product Records shall be subject to inspection and audit by and at the expense of the Other Party no more than two times in any Annual Period. Such audits shall occur upon reasonable notice and during normal business hours by an independent auditor selected by the Other Party and reasonably acceptable to the Responsible Party. The Other Party shall treat all information received or subject to review under this Section 3.3(d) as Confidential Information of the Responsible Party in accordance with the provisions of Article VIII. The Other Party shall cause its independent auditor to enter into a confidentiality agreement, in form and substance reasonably acceptable to the Responsible Party, to maintain such records and information of the Responsible Party in confidence in accordance with Article VIII and not use such records or information except to the extent permitted by this Agreement, including any enforcement of the provisions hereof. (e) The Parties shall enter into one or more safety exchange or pharmaco-vigilance agreements (each, a “PV Agreement”) on reasonable and customary terms to ensure compliance with safety reporting requirements of all applicable Regulatory Agencies globally (including in connection with maintaining the MAA Approval and any Regulatory NDA Approval for Product in the TerritoryProduct) by providing detailed procedures regarding the collection, exchange and management of safety data relating to Product, including but not limited to the establishment and maintenance of a global safety database (which database shall be maintained by Alvogen), Adverse Drug Responses collection and reporting, and maintenance of core safety information. Pfenex (itself, its Affiliates and licensees) shall have reasonable access to such database and the data therein, including the right to query such data to determine and report safety signals.