Common use of Recalls and Voluntary Withdrawals Clause in Contracts

Recalls and Voluntary Withdrawals. 5.5.1 For each country in the Territory, Kyowa Kirin and Reata will, through the JSC, confer and coordinate regarding their respective internal standard operating procedures (and any changes thereto) regarding product recalls and the treatment of and response to product complaints and inquiries as to safety, quality or efficacy that would be relevant to the Licensed Products. 5.5.2 If either Party becomes aware of information about a Licensed Product indicating that it may not conform to the Specifications or that there are potential adulterations, misbranding and/or other material adverse issues regarding safety of a Licensed Product (or otherwise that a recall or withdrawal of a Licensed Product is potentially at issue), it will as soon as practical (but in any event within such period as the Parties may mutually establish to ensure their respective compliance with Applicable Law) so notify the other Party. With respect to the Territory, the Parties will promptly meet to discuss such circumstances and to consider appropriate courses of action, including Licensed Product recalls. Unless agreed by the Parties in writing, Kyowa Kirin will make any decisions regarding, and implement and be responsible, at its sole expense (except as provided below), for all recalls of Licensed Product in the Territory, and will maintain complete and accurate records of any Licensed Product recall for such periods as may be required by legal requirements. Notwithstanding the foregoing, Reata shall reimburse Kyowa Kirin for the reasonable and necessary out-of-pocket expenses incurred by Kyowa Kirin for any recalls of Licensed Products (or API) manufactured or supplied by or for Reata to Kyowa Kirin hereunder to the extent attributable to the failure of such Licensed Product or API to conform to the Specifications or to be manufactured in compliance with Applicable Laws, which failure was due to negligence or was known to Reata (or its suppliers) or could reasonably have been discovered by Reata (or its suppliers) with the application of reasonable and customary quality assurance and quality control practices or the application of GMPs, and such failure could not have been identified or detected by Kyowa Kirin (or if applicable its Permitted Sublicensees) through its application of reasonable and customary quality assurance and quality control practices, or other inspections or activities required under Applicable Law with respect to such Licensed Products, prior to distribution of the Licensed Product in the Territory.

Recalls and Voluntary Withdrawals. 5.5.1 For each country in the Territory, Kyowa Kirin The Parties shall exchange and Reata will, through the JSC, confer and coordinate regarding provide timely updates to their respective internal standard operating procedures (and any changes thereto"SOPs") regarding for conducting product recalls and reasonably in advance of the treatment First Commercial Sale of and response to product complaints and inquiries as to safety, quality or efficacy that would be relevant to any Product in the Licensed Products. 5.5.2 Territory, and shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information about relating to any Product that indicates that a Licensed unit or batch of Finished Product indicating that it or Bulk API may not conform to the Specifications specifications therefor, or that there are potential adulterationsadulteration, misbranding and/or misbranding, or other material adverse issues regarding have arisen that relate to the safety or efficacy of a Licensed Product (or otherwise that a recall or withdrawal of a Licensed Product is potentially at issue)the Product, it will as soon as practical (but in any event within such period as the Parties may mutually establish to ensure their respective compliance with Applicable Law) shall promptly so notify the other Party. With respect to the Territory, the Parties will promptly The JSC shall meet to discuss such circumstances and to consider and decide appropriate courses of action, including which shall be consistent with the internal SOP of Takeda. The Party that holds the applicable Regulatory Approval shall have the right and responsibility to control any product recall, field correction, or withdrawal of any Product in the Licensed Product recalls. Unless Territory that is required by Regulatory Authorities in the Licensed Territory, and the allocation of expenses incurred in connection with such recall between the Parties shall be made as follows: (i) if the recall is due to manufacturing defect (in accordance with then prevailing U.S. product liability Laws, unless otherwise agreed upon by the Parties in writingthe Supply Agreement) of Bulk API, Kyowa Kirin will make then Affymax shall bear all such expenses, (ii) if the recall is due to manufacturing defect (in accordance with then prevailing U.S. product liability Laws, unless otherwise agreed upon by the Parties in the Supply Agreement) of Finished Product (other than due to manufacturing defect of Bulk API), then Takeda shall bear all such expenses, (iii) if the recall is due to both of (i) and (ii), then the Parties shall share all such expenses proportionately and (iv) otherwise, as follows: (1) 100% to Takeda to the extent attributable to a recall in any decisions regardingcountry in the Royalty Territory; (2) treated as Commercial Expenses to the extent attributable to a recall in the U.S., and implement and or (3) or as otherwise may be responsibleagreed for one or more territories in the Supply Agreement as described in Section 7.3. In addition, Takeda shall have the right, at its sole expense (except as provided below)discretion, for all recalls to conduct any product recall, field correction or withdrawal of Licensed any Product in the TerritoryLicensed Territory that is not so required by such Regulatory Authorities but that Takeda deems to be appropriate, and will the allocation of expenses incurred in connection with such recall between the Parties shall be as set forth in the immediately preceding sentence. Takeda shall maintain complete and accurate records of any recall in the Licensed Product recall Territory for such periods as may be required by legal requirements. Notwithstanding the foregoing, Reata shall reimburse Kyowa Kirin for the reasonable and necessary out-of-pocket expenses incurred by Kyowa Kirin for any recalls of Licensed Products (or API) manufactured or supplied by or for Reata to Kyowa Kirin hereunder to the extent attributable to the failure of such Licensed Product or API to conform to the Specifications or to be manufactured in compliance with Applicable applicable Laws, which failure was due to negligence or was known to Reata but no event for less than three (or its suppliers3) or could reasonably have been discovered by Reata (or its suppliers) with the application of reasonable and customary quality assurance and quality control practices or the application of GMPs, and such failure could not have been identified or detected by Kyowa Kirin (or if applicable its Permitted Sublicensees) through its application of reasonable and customary quality assurance and quality control practices, or other inspections or activities required under Applicable Law with respect to such Licensed Products, prior to distribution of the Licensed Product in the Territoryyears.

Recalls and Voluntary Withdrawals. 5.5.1 For each country in the Territory, Kyowa Kirin and Reata will, through the JSC, confer and coordinate regarding The Parties shall exchange their respective internal standard operating procedures (and any changes thereto"SOPs") regarding for conducting product recalls and reasonably in advance of the treatment First Commercial Sale of and response to product complaints and inquiries as to safety, quality or efficacy that would be relevant to any Product in the Licensed Products. 5.5.2 Territory, and shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information about relating to any Product that indicates that a Licensed unit or batch of Finished Product indicating that it or Bulk Hematide may not conform to the Specifications specifications therefor, or that there are potential adulterationsadulteration, misbranding misbranding, and/or other material adverse issues regarding have arisen that relate to the safety or efficacy of a Licensed Product (or otherwise that a recall or withdrawal of a Licensed Product is potentially at issue)Products, it will as soon as practical (but in any event within such period as the Parties may mutually establish to ensure their respective compliance with Applicable Law) shall promptly so notify the other Party. With respect to the Territory, the Parties will promptly The Joint Committee shall meet to discuss such circumstances and to consider appropriate courses of action, including which shall be consistent with the internal SOP of the Party having the right to control such recall pursuant to this Section 4.11. Collaborator shall have the right and responsibility to control any product recall, field correction, or withdrawal of any Product in the Licensed Product recalls. Unless agreed Territory that is required by Regulatory Authorities in the Licensed Territory, and the allocation of expenses incurred in connection with such recall between the Parties shall be set forth in the Supply Agreement as described in Section 7.3. In addition, Collaborator shall have the right, at its discretion, to conduct any product recall, field correction or withdrawal of any Product in the Licensed Territory that is not so required by such Regulatory Authorities but that Collaborator deems to be appropriate, with the allocation of expenses incurred in connection with such recall between the Parties to be set forth in the Supply Agreement as described in Section 7.3. As between the Parties, Affymax shall have the right, at its expense, to control all recalls, field corrections, and withdrawals of any Product in the Affymax Territory, provided, however, that Affymax shall use reasonable efforts (subject to its confidentiality obligations to the Third Party Partner, provided that Affymax shall, during the course of negotiation to enter into an agreement with such Third Party Partner, use reasonable efforts to secure its right to inform Collaborator of such event) to inform the Collaborator of such intention in advance in writing, Kyowa Kirin will make any decisions regarding, and implement and be responsible, at its sole expense (except as provided below), for all recalls of Licensed Product if such recall may reasonably have a material effect in the Territory, and will Licensed Territory but such information is not otherwise required to be provided pursuant to Section 4.9(a). Collaborator shall maintain complete and accurate records of any recall in the Licensed Product recall Territory for such periods as may be required by legal requirements. Notwithstanding the foregoing, Reata shall reimburse Kyowa Kirin for the reasonable and necessary out-of-pocket expenses incurred by Kyowa Kirin for any recalls of Licensed Products (or API) manufactured or supplied by or for Reata to Kyowa Kirin hereunder to the extent attributable to the failure of such Licensed Product or API to conform to the Specifications or to be manufactured in compliance with Applicable applicable Laws, which failure was due to negligence or was known to Reata but no event for less than three (or its suppliers3) or could reasonably have been discovered by Reata (or its suppliers) with the application of reasonable and customary quality assurance and quality control practices or the application of GMPs, and such failure could not have been identified or detected by Kyowa Kirin (or if applicable its Permitted Sublicensees) through its application of reasonable and customary quality assurance and quality control practices, or other inspections or activities required under Applicable Law with respect to such Licensed Products, prior to distribution of the Licensed Product in the Territoryyears.

Recalls and Voluntary Withdrawals. 5.5.1 For each country in the Territory, Kyowa Kirin and Reata will, through the JSC, confer and coordinate regarding (a) The Parties shall exchange their respective internal standard operating procedures (and any changes thereto“SOPs”) regarding as to product recalls and the treatment of and response to product complaints and inquiries as to safety, quality or efficacy that would be relevant to reasonably in advance of the date of Commercial Launch of any Licensed Products. 5.5.2 Product in the Territory. If either Party becomes aware of information about a any Licensed Product indicating that it may not conform to the Specifications specifications for Licensed Product then in effect pursuant to the Supply Agreement, or that there are potential adulterationsadulteration, misbranding and/or other material adverse issues regarding safety of a Licensed Product (or otherwise that a recall or withdrawal of a Licensed Product is potentially at issue)effectiveness, it will as soon as practical (but in any event within such period as the Parties may mutually establish to ensure their respective compliance with Applicable Law) shall promptly so notify the other Party. With respect to the Territory, the Parties will promptly The JCT shall meet to discuss such circumstances and to consider appropriate courses of action, including Licensed Product recallswhich courses of action with respect to each recall shall be consistent with the internal SOP of the Party having the right to control such recall pursuant to this Section 5.7. Unless agreed by Except to the Parties extent otherwise provided in writingSection 5.7(b) below, Kyowa Kirin will make any decisions regarding, and implement and be responsibleChiron shall control, at its sole expense (except as provided below)expense, for all recalls of Licensed Product in within the Territory. Cubist shall control, and will at its sole expense, all recalls of Licensed Product outside the Territory. Chiron shall maintain complete and accurate records of any Licensed Product recall for such periods as may be required by legal requirements. Notwithstanding , but in any event for no less than three (3) years. (b) In the foregoing, Reata shall reimburse Kyowa Kirin for the reasonable and necessary out-of-pocket expenses incurred by Kyowa Kirin for event that any recalls recall of Licensed Products (Product in the Territory is required or API) manufactured or supplied necessary by or for Reata to Kyowa Kirin hereunder to the extent attributable to the failure virtue of such Licensed Product or API being Defective Manufactured Product, then both Parties shall work together to conform devise a reasonable and appropriate plan to implement such recall, it being understood that the objective of such plan shall be to effect such recall as quickly and as cost-effectively as reasonably possible under the circumstances. After the Parties shall have reached agreement on the terms of such plan (or, in the event that the Parties cannot reach agreement as to the Specifications or terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to be manufactured adopt another plan), Chiron shall implement such recall in compliance with Applicable Laws, which failure was due to negligence or was known to Reata (or its suppliers) or could reasonably have been discovered by Reata (or its suppliers) a manner consistent with the application terms of reasonable such plan. Cubist shall cooperate with Chiron in any way that Chiron reasonably requests in order to support the implementation of such recall. Subject to the limitation of liability set forth in Section 10.6(a), Cubist shall reimburse Chiron for all Recall Expenses (as defined below) provided that [*]. For the avoidance of doubt, the limitation set forth above in this Section 5.7(b) (and customary quality assurance in Section 6.6(b) of the Supply Agreement) on Cubist’s responsibility for Recall Expenses shall not apply to limit Chiron’s remedies and quality control practices Cubist’s obligations or the application of GMPs, and such failure could not have been identified or detected by Kyowa Kirin (or if applicable its Permitted Sublicensees) through its application of reasonable and customary quality assurance and quality control practices, or other inspections or activities required under Applicable Law liabilities with respect to such Licensed Productsmatters other than Recall Expenses, prior including, without limitation, (i) Cubist’s obligation to distribution indemnify Chiron pursuant to Sections 10.1 and 10.3 of this Agreement with respect to costs and expenses other than Recall Expenses, and (ii) Chiron’s remedies under Sections 8.1, 9.1(d) and 11.6 of the Supply Agreement. “Recall Expenses” shall mean the costs and expenses incurred by Chiron in connection with a recall of Licensed Product that is implemented in accordance with this Section 5.7(b) (and/or Section 6.6(b) of the Territory.Supply Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION

Recalls and Voluntary Withdrawals. 5.5.1 For each country in the Territory, Kyowa Kirin 5.6.1 Teijin and Reata Versartis will, through the JSC, confer upon and coordinate regarding their respective internal standard operating procedures (and any changes thereto) regarding with respect to product recalls and the treatment of and response to product complaints and inquiries as to regarding the safety, quality quality, or efficacy that would be relevant to of the Licensed ProductsProducts in the Territory. 5.5.2 5.6.2 If either Party becomes aware of information about a Licensed Product indicating that it may not conform to the Specifications or that there are potential adulterations, misbranding misbranding, and/or other material adverse issues regarding safety of a Licensed Product (or otherwise that a recall or withdrawal of a Licensed Product in the Territory is potentially at issue), it will shall as soon as practical (but in any event within such period of time as the Parties may mutually establish to ensure their respective compliance with Applicable LawLaws) so notify the other Party. With respect to the Territory, the Parties will shall promptly meet in person or via teleconference to discuss such circumstances and to consider appropriate courses of action, including Licensed Product recalls. Unless otherwise agreed in writing by the Parties in writingParties, Kyowa Kirin Teijin will make any decisions regarding, and implement and be responsibleresponsible for, at its sole expense (except as provided below), for all recalls of Licensed Product Products in the Territory, and will maintain complete and accurate records of any all Licensed Product recall recalls for such periods as may be required by legal requirementsApplicable Laws. Notwithstanding the foregoing, Reata Versartis shall reimburse Kyowa Kirin Teijin for a percentage of the reasonable and necessary out-of-pocket expenses incurred by Kyowa Kirin Teijin for any recalls of Licensed Products (or APIFinished Product or Drug Product) manufactured or supplied by [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. or for Reata Versartis to Kyowa Kirin Teijin hereunder solely to the extent such recall is attributable to (x) the failure of such Licensed Product Product, Finished Product, or API Drug Product, as applicable, to conform to the Specifications or to be manufactured in compliance with Applicable Laws, or (y) any demonstrated design defect or inherent defect in the Licensed Product, Finished Product, or Drug Product, which failure was due percentage shall be as follows: 5.6.3 [ * ] percent ([ * ]%) where such recall is demonstrated to be attributable solely to the negligence of one or was known to Reata (or its suppliers) or could reasonably have been discovered by Reata (or its suppliers) with more members of the application of reasonable and customary quality assurance and quality control practices or the application of GMPsVersartis Group, and such failure could not have been identified or detected by Kyowa Kirin (or if applicable its Permitted Sublicensees) through its application to the negligence of reasonable and customary quality assurance and quality control practices, or other inspections or activities required under Applicable Law with respect to such Licensed Products, prior to distribution any member of the Licensed Product Teijin Group; 5.6.4 [ * ] percent ([ * ]%) where such recall is demonstrated to be attributable solely to the negligence of one or more members of the Teijin Group, and not to the negligence of any member of the Versartis Group; 5.6.5 [ * ] percent ([ * ]%), where such recall is demonstrated to be attributable both to (x) the negligence of one or more members of the Versartis Group, including any Latent Defect, and also (y) the negligence of any member of the Teijin Group (such as for example, failure to properly test and release Finished Product); 5.6.6 [ * ] percent ([ * ]%), where such recall is (x) not demonstrated to be attributable to the negligence of either (i) any member of the Versartis Group or (ii) any member of the Teijin Group, but (y) is demonstrated instead to be attributable to a design defect or inherent defect in the TerritoryFinished Product, Drug Product or Licensed Product; or 5.6.7 [ * ] percent ([ * ]%) where such recall is (x) not demonstrated to be attributable to the negligence of either (i) any member of the Versartis Group or (ii) any member of the Teijin Group, and (y) not demonstrated to be based upon any design defect or inherent defect in the Finished Product.