Common use of Product Inquiries and Complaints Clause in Contracts

Product Inquiries and Complaints. (a) With respect to Products Manufactured by Patheon, each Party will promptly (as may be further defined in the Quality Agreement) submit to the other Party any Product safety and efficacy inquiries, Product quality complaints, and adverse drug event reports received by such Party, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the Parties. Except as otherwise required by, or to comply with, Applicable Law or the terms of this Agreement, Flexion, as the Party holding the applicable Regulatory Approval, will be responsible for investigating and responding to all such inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority. (b) Pursuant to a reported complaint or adverse drug event pertaining to the Products Manufactured by Patheon, if the nature of the reported complaint or adverse drug event requires testing, Patheon will, upon Flexion’s request and approval, perform analytical testing of corresponding Product complaint or retention samples and provide the results thereto to Flexion as soon as reasonably practicable, but no later than […***…] days after Flexion’s request. Such testing shall be performed using approved testing procedures as set forth in the applicable Regulatory Approval or the Quality Agreement. If such analytical testing concludes that the reported complaint or adverse drug event was the result of a Patheon Nonconformance, Patheon shall reimburse Flexion for […***…] associated with such complaint or adverse drug event and incurred by Flexion with respect to such nonconforming Product, including […***…]. Costs of recalls will be dealt with in accordance with Section 3.12. If such analytical testing concludes that the reported complaint or adverse drug event was not the result of a Patheon Nonconformance, Flexion shall compensate Patheon for all costs associated with such complaint or adverse drug event and incurred by Patheon with respect to such nonconforming Product, including costs of recalls, market withdrawals, returns, and destruction. (c) If the Parties disagree as to which Party is responsible, Patheon and Flexion representatives shall attempt to resolve such dispute. If the representatives cannot resolve such dispute within […***…] days, the retention samples shall be submitted by Patheon and Flexion to an Expert and Section 2.8 shall apply.

Product Inquiries and Complaints. (a) With respect to Products Manufactured by Patheon, each Party will promptly (as may be further defined in the Quality Agreement) submit to the other Party any Product safety and efficacy inquiries, Product quality complaints, and adverse drug event reports received by such Party, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the Parties. Except as otherwise required by, or to comply with, Applicable Law or the terms of this Agreement, FlexionPacira, as the Party holding the applicable Regulatory Approval, will be responsible for investigating and responding to all such inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority. (b) Pursuant to a reported complaint or adverse drug event pertaining to the Products Manufactured manufactured by Patheon, if the nature of the reported complaint or adverse drug event requires testing, Patheon will, upon FlexionPacira’s request and approval, perform analytical testing of corresponding Product complaint or retention samples and provide the results thereto to Flexion Pacira as soon as reasonably practicable, but no later than […***…] days after FlexionPacira’s request. Such testing shall be performed using approved testing procedures as set forth in the applicable Regulatory Approval or the Quality Agreement. If such analytical testing concludes that the reported complaint or adverse [**] - Indicates certain information has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the redacted portions. drug event was the result of a Patheon Nonconformance, subject to Pacira having provided to Patheon a Deficiency Notice in accordance with the provisions of Section 2.8 including as to timing, Patheon shall reimburse Flexion Pacira for […***…] associated with such complaint or adverse drug event and incurred by Flexion Pacira with respect to such nonconforming Product, including […**], which costs Pacira shall have the right to [*…*]. Costs of recalls will be dealt with in accordance with Section 3.123.13. If such analytical testing concludes that the reported complaint or adverse drug event was not the result of a Patheon Nonconformance, Flexion Pacira shall compensate Patheon for all costs associated with such complaint or adverse drug event and incurred by Patheon with respect to such nonconforming Product, including costs of recalls, market withdrawals, returns, and destruction. (c) If the Parties disagree as to which Party is responsible, Patheon and Flexion Pacira representatives shall attempt to resolve such dispute. If the representatives cannot resolve such dispute within […***…] days], the retention samples shall be submitted by Patheon and Flexion Pacira to an Expert and Section 2.8 shall apply.

Product Inquiries and Complaints. (a) With respect to Products Manufactured by Patheon, each Party Patheon will promptly (as may be further defined in the Quality Agreement) submit to the other Party Client any Product safety and efficacy inquiries, Product quality complaints, and adverse drug event reports received by such Partythat it receives, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the Parties. Patheon will promptly advise Client of any occurrence or information which arises out of the Manufacture of Products which has or could be reasonably expected to have adverse regulatory compliance and/or reporting consequences concerning the Products, and provide relevant information to Client upon request. Except as otherwise required by, or to comply with, Applicable Law or the terms of this Agreement, FlexionClient, as the Party holding the applicable Regulatory ApprovalMarketing Authorization, will be responsible for investigating and responding to all such inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) Pursuant to a any reported complaint or complaint, adverse drug event pertaining or other issue which may pertain to the Products Manufactured by Patheon, if the nature Manufacture of the reported complaint or adverse drug event requires testingProducts Patheon will promptly conduct all such necessary internal investigations as may be necessary to determine the validity of such complaint, Patheon will, upon Flexion’s request and approval, perform including performing analytical testing of corresponding Product complaint Products or retention samples samples, and shall provide the results thereto to Flexion Client as soon as reasonably practicable, but no later than […***…] days after FlexionClient’s request. Such testing shall be performed using approved testing procedures as set forth in the applicable Regulatory Approval or the Quality Agreement. If such investigation or analytical testing concludes that the reported complaint or adverse drug event was the result of a Patheon Nonconformance, subject to Client having provided to Patheon a Deficiency Notice in accordance with the provisions of Section 2.8(b) including as to timing, Patheon shall reimburse Flexion for […***…] associated with such complaint or adverse drug event and incurred by Flexion Client with respect to such nonconforming Non-Conforming Product, including reasonable […***…]. Costs of recalls will be dealt with in accordance with Section 3.123.14. If such investigation or analytical testing concludes that the reported complaint or adverse drug event was not the result of a Patheon Nonconformance, Flexion Client shall compensate Patheon for all costs associated with such complaint or adverse drug event and incurred by Patheon with respect to such nonconforming Non-Conforming Product, including costs of recalls, market withdrawals, returns, and destruction. (c) If the Parties disagree as to which Party is responsible, Patheon and Flexion Client representatives shall attempt to resolve such dispute. If the representatives cannot resolve such dispute within on or before […***…] days, the retention samples shall be submitted by Patheon and Flexion Client to an Expert and Section 2.8 2.8(d)(vi) shall apply.

Product Inquiries and Complaints. (a) With respect to Products Manufactured by Patheon, each Party will promptly (as may be further defined in the Quality Agreement) submit to the other Party any Product safety and efficacy inquiries, Product quality complaints, and adverse drug event reports received by such Party, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the Parties. Except as otherwise required by, or to comply with, Applicable Law or the terms of this Agreement, Flexion, as the Party holding the applicable Regulatory Approval, will be responsible for investigating and responding to all such inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority. (b) Pursuant to a reported complaint or adverse drug event pertaining to the Products Manufactured by Patheon, if the nature of the reported complaint or adverse drug event requires testing, Patheon will, upon Flexion’s request and approval, perform analytical testing of corresponding Product complaint or retention samples and provide the results thereto to Flexion as soon as reasonably practicable, but no later than […***…] days after Flexion’s request. Such testing shall be performed using approved testing procedures as set forth in the applicable Regulatory Approval or the Quality Agreement. If such analytical testing concludes that the reported complaint or adverse drug event was the result of a Patheon Nonconformance, Patheon shall reimburse Flexion for […***…] associated with such complaint or adverse drug event and incurred by Flexion with respect to such nonconforming Product, including […***…]. Costs of recalls will be dealt with in accordance with Section 3.12. If such analytical testing concludes that the reported complaint or adverse drug event was not the result of a Patheon Nonconformance, Flexion shall compensate Patheon for all costs associated with such complaint or adverse drug event and incurred by Patheon with respect to such nonconforming Product, including costs of recalls, market withdrawals, returns, and destruction. (c) If the Parties disagree as to which Party is responsible, Patheon and Flexion representatives shall attempt to resolve such dispute. If the representatives cannot resolve such dispute within […***…] days, the retention samples shall be submitted by Patheon and Flexion to an Expert and Section 2.8 shall apply.* Certain Confidential Information Omitted - 27 -

Product Inquiries and Complaints. (a) With respect to For Products Manufactured by Patheon, each Party Patheon will promptly (as may be further defined in the Quality Agreement) submit to the other Party Client any Product safety and efficacy inquiries, Product quality complaints, and adverse drug event reports received by such Partythat it receives, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the Parties. Patheon will promptly advise Client of any occurrence or information which arises out of the Manufacture of Products which has or could be reasonably expected to have adverse regulatory compliance and/or reporting consequences concerning the Products, and provide relevant information to Client upon request. Except as otherwise required by, or to comply with, Applicable Law or the terms of this Agreement, FlexionClient, as the Party holding the applicable Regulatory ApprovalMarketing Authorization, will be responsible for investigating and responding to all such these inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority. [***] 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. (b) Pursuant to a Under any reported complaint or complaint, adverse drug event pertaining or other issue which may pertain to the Products Manufactured by Patheon, if the nature Manufacture of the reported complaint or adverse drug event requires testingProducts Patheon will promptly conduct an internal investigations as may be reasonably necessary to determine the validity of the complaint, Patheon will, upon Flexion’s request and approval, perform including performing analytical testing of corresponding Product complaint Products or retention samples samples, and will provide the results thereto to Flexion Client as soon as reasonably practicable, but no later than […***…] days after FlexionClient’s request. Such This testing shall will be performed using approved testing procedures as set forth in the applicable Regulatory Approval or the Quality Agreement. If such the investigation or analytical testing concludes that the reported complaint or adverse drug event was the result of a Patheon Nonconformance, subject to Client having given Patheon shall a Deficiency Notice in accordance with Section 2.8(b) including as to timing, Patheon will reimburse Flexion Client for […***…] all reasonable out-of-pocket expenses associated with such the complaint or adverse drug event and incurred by Flexion with respect to such nonconforming Client for the Non-Conforming Product, including […***…]reasonable costs of returns and destruction. Costs of recalls will be dealt with in accordance with Section 3.123.14. If such the investigation or analytical testing concludes that the reported complaint or adverse drug event was not the result of a Patheon Nonconformance, Flexion shall Client will compensate Patheon for all costs associated with such the complaint or adverse drug event and incurred by Patheon with respect to such nonconforming for the Non-Conforming Product, including costs of recalls, market withdrawals, returns, and destruction. (c) If the Parties disagree as to which Party is responsible, Patheon and Flexion Client representatives shall will attempt to resolve such the dispute. If the representatives cannot resolve such the dispute within […***…] 15 days, the retention samples shall will be submitted by Patheon and Flexion Client to an Expert and Section 2.8 shall 2.8(d)(vi) will apply.