Common use of Recalls and Voluntary Withdrawals Clause in Contracts

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures ("SOPS") as to product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of Commercial Launch of any Licensed Product in the Territory. If either Party becomes aware of information about any Licensed Product indicating that it may not conform to the Specifications for Licensed Product then in effect, or that there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, it shall promptly so notify the other Party. The JCT shall meet to discuss such circumstances and to consider appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> 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 6.6. Except to the extent otherwise provided in Section 6.6(b) below, Chiron shall control, at its sole expense, all recalls of Licensed Product within the Territory. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron shall maintain complete and accurate records of any recall for such periods as may be required by legal requirements, but in any event for no less than three (3) years. (b) In the event that any recall of Licensed Product in the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) of the License Agreement, 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 6.6(b) (and in Section 5.7(b) of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply to limit Chiron's remedies and Cubist's obligations or liabilities with respect to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 of the License 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 this 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 6.6(b) (and/or Section 5.7(b) of the License Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures ("SOPS"“SOPs”) as to for conducting product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of First Commercial Launch Sale of any Licensed Product in the Licensed 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 Licensed Product indicating that it indicates that a unit or batch of Finished Product or Bulk Hematide may not conform to the Specifications for Licensed Product then in effectspecifications therefor, or that there are potential adulteration, misbranding misbranding, and/or other issues regarding have arisen that relate to the safety or effectivenessefficacy of Products, it shall promptly so notify the other Party. The JCT Joint Committee shall meet to discuss such circumstances and to consider appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> 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 6.64.11. Except Collaborator shall have the right and responsibility to control any product recall, field correction, or withdrawal of any Product in the Licensed 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 a manufacturing defect in accordance with then prevailing U.S. product liability Laws, unless otherwise agreed upon by the Parties in the Supply Agreement (as defined in Section 7.3 hereof) for Bulk Hematide, then Affymax shall bear all such expenses, (ii) if the recall is due to a 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 Hematide), then Collaborator 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, 100% to Collaborator to the extent attributable to a recall in the Licensed Territory, unless otherwise provided may be agreed in Section 6.6(b) belowthe Supply Agreement. In addition, Chiron Collaborator shall controlhave the right, at its sole expensediscretion, all recalls to conduct any product recall, field correction or withdrawal of any Product in the Licensed Product within Territory that is not so required by such Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the TerritorySecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Cubist shall controlAuthorities but that Collaborator deems to be appropriate, at its sole expense, all recalls with the allocation of Licensed Product outside expenses incurred in connection with such recall between the TerritoryParties to be as set forth in the immediately preceding sentence. Chiron Collaborator shall maintain complete and accurate records of any recall in the Licensed Territory for such periods as may be required by legal requirementsapplicable Laws, but in any no event for no less than three (3) years. (b) In the event that any recall of Licensed Product in the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) of the License Agreement, 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 6.6(b) (and in Section 5.7(b) of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply to limit Chiron's remedies and Cubist's obligations or liabilities with respect to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 of the License 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 this 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 6.6(b) (and/or Section 5.7(b) of the License Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange and provide timely updates to their internal standard operating procedures ("SOPS"“SOPs”) as to for conducting product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of First Commercial Launch Sale of any Licensed Product in the Licensed 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 Licensed Product indicating that it indicates that a unit or batch of Finished Product or Bulk API may not conform to the Specifications for Licensed Product then in effectspecifications therefor, or that there are potential adulteration, misbranding and/or misbranding, or other issues regarding have arisen that relate to the safety or effectivenessefficacy of the Product, it shall promptly so notify the other Party. The JCT JSC shall meet to discuss such circumstances and to consider and decide appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> courses of action with respect to each recall shall be consistent with the internal SOP of Takeda. The Party that holds the Party having applicable Regulatory Approval shall have the right and responsibility to control any product recall, field correction, or withdrawal of any Product in the Licensed Territory that is required by Regulatory Authorities in the Licensed Territory, and the allocation of expenses incurred in connection with such recall pursuant between the Parties shall be made as follows: (i) if the recall is due to this Section 6.6. Except manufacturing defect (in accordance with then prevailing U.S. product liability Laws, unless otherwise agreed upon by the Parties in the Supply Agreement) of Bulk API, 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 country in the Royalty Territory; (2) treated as Commercial Expenses to the extent attributable to a recall in the U.S., or (3) or as otherwise provided may be agreed for one or more territories in the Supply Agreement as described in Section 6.6(b) below7.3. In addition, Chiron Takeda shall controlhave the right, at its sole expensediscretion, all recalls to conduct any product recall, field correction or withdrawal of any Product in the Licensed Product within Territory that is not so required by such Regulatory Authorities but that Takeda deems to be appropriate, and the Territoryallocation of expenses incurred in connection with such recall between the Parties shall be as set forth in the immediately preceding sentence. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron Takeda shall maintain complete and accurate records of any recall in the Licensed Territory for such periods as may be required by legal requirementsapplicable Laws, but in any no event for no less than three (3) years. (b) In the event that any recall of Licensed Product in the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) of the License Agreement, 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 6.6(b) (and in Section 5.7(b) of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply to limit Chiron's remedies and Cubist's obligations or liabilities with respect to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 of the License 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 this 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 6.6(b) (and/or Section 5.7(b) of the License Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7.

Recalls and Voluntary Withdrawals. (a) The Parties JSC shall exchange their assign responsibility to TGTX for providing its internal standard operating procedures ("SOPS"“SOPs”) as for conducting any recall, field alert, product withdrawal or other field action relating to the finished product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of First Commercial Launch Sale of any Licensed Product in the TerritoryTerritory to the other party. If either Party becomes aware of information about relating to any Licensed Product indicating that it indicates that a unit or batch of Finished Product or Bulk API may not conform to the Specifications for Licensed Product then in effectspecifications therefor, or that there are potential adulteration, misbranding and/or misbranding, or other issues regarding have arisen that relate to the safety or effectivenessefficacy of the Product, it shall promptly so notify the other Party. The JCT JSC shall meet to discuss such circumstances and to consider and decide appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> courses of action with respect to each recall shall be consistent with the internal SOP of the Party having TGTX, TGTX shall have the right and responsibility to control any product recall, field correction, or withdrawal of any Product in the Territory that is required by Regulatory Authorities in the Territory, and the allocation of reasonable expenses incurred in connection with such recall pursuant between the Parties shall be made as follows: (i) if the recall is primarily due to failure by Rhizen or its contract manufacturer to manufacture the finished product in accordance with the agreed upon specification and applicable laws, then Rhizen shall bear all such expenses, (ii) if the recall is primarily due to a failure by TGTX to comply with its obligation under this Section 6.6. Except agreement or the commercial supply agreement, including with respect to the extent otherwise provided in Section 6.6(blabeling, possession, storage or distribution of the finished product, then TGTX shall bear all such expenses, and (iii) belowotherwise, Chiron such expenses shall controlbe treated as Commercial Expenses. In addition, TGTX shall have the right, at its sole expensediscretion, all recalls to conduct any product recall, field correction or withdrawal of Licensed any Product within in the TerritoryTerritory that is not so required by such Regulatory Authorities but that TGTX deems to be appropriate, and the allocation of expenses incurred in connection with such recall between the Parties shall be as set forth in the immediately preceding sentence. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron TGTX shall maintain complete and accurate records of any recall in the Territory for such periods as may be required by legal requirementsapplicable Laws, but in any no event for no less than three (3) years. (b) In If the event that any recall of Licensed Product in parties are unable to agree on which party is responsible for the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) cost of the License Agreement, Cubist shall reimburse Chiron for all Recall Expenses (as defined below) provided that [*] For the avoidance of doubtrecall pursuant to this section 4.7, the limitation set forth above in this Section 6.6(b) (and in Section 5.7(b) parties agree to submit a sample of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply finished product to limit Chiron's remedies and Cubist's obligations or liabilities with respect an independent third party analyst to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 determine the cause of the License 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 this Supply Agreementdefect. "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 6.6(b) (and/or Section 5.7(b) The cost of the License Agreement), including, without limitation, report of the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7independent analyst will be paid by the party against which the report is unfavorable.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures ("SOPS"“SOPs”) as to for conducting product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date First Commercial Sale of Commercial Launch of any Licensed Product in the 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 Licensed released Product indicating that it indicates that a unit or batch of Product may not conform to the Specifications for Licensed Product then in effectspecifications thereof, or that there are potential adulteration, misbranding misbranding, and/or other issues regarding have arisen that relate to the safety or effectivenessefficacy of such released Product, it shall promptly so notify the other Party. The JCT To the extent Daewoong requires such information to comply with applicable Laws or to determine whether to conduct a recall, Ampio shall meet promptly disclose to discuss Daewoong any CMC Information related to such circumstances and nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to consider appropriate courses control any Product recall, field correction, or withdrawal of actionany released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> courses at its expense, to control any Product recall, field correction, or withdrawal of action with respect to each recall any released Product in the Retained Territory. Ampio shall be consistent with responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the internal SOP Territory to the extent such event of recall, field correction, or withdrawal is due to the material breach by Ampio of this Agreement or the Supply Agreement. Daewoong shall be responsible for all other costs incurred for any recall, field correction, or withdrawal of any released Product for the Territory. The procedures and consequences of such recalls shall be defined in the Supply Agreement. The Party having the right to control such recall pursuant to this Section 6.6. Except to the extent otherwise provided in Section 6.6(b) below, Chiron shall control9.8 may, at its sole expensediscretion, all recalls take appropriate courses of Licensed Product within action, which shall be consistent with the Territoryinternal SOPs of such Party; provided, however, that such controlling Party shall promptly notify the other Party of any recall action being considered and where practicable, consider the views of the non-controlling Party prior to taking any recall action. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron Daewoong shall maintain complete and accurate records of any recall according to its then current SOPs in the Territory for such periods as may be required by legal requirementsapplicable Laws, but in any no event for no less than three (3) years. (b) In the event that any recall of Licensed Product in the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) of the License Agreement, 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 6.6(b) (and in Section 5.7(b) of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply to limit Chiron's remedies and Cubist's obligations or liabilities with respect to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 of the License 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 this 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 6.6(b) (and/or Section 5.7(b) of the License Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures ("SOPS"“SOPs”) as to for conducting product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of First Commercial Launch Sale of any Licensed Product in the Licensed 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 Licensed Product indicating that it indicates that a unit or batch of Finished Product or Bulk Hematide may not conform to the Specifications for Licensed Product then in effectspecifications therefor, or that there are potential adulteration, misbranding misbranding, and/or other issues regarding have arisen that relate to the safety or effectivenessefficacy of Products, it shall promptly so notify the other Party. The JCT Joint Committee shall meet to discuss such circumstances and to consider appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> 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 6.64.11. Except Collaborator shall have the right and responsibility to control any product recall, field correction, or withdrawal of any Product in the extent otherwise provided Licensed 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 6.6(b) below7.3. In addition, Chiron Collaborator shall controlhave the right, at its sole expensediscretion, all recalls to conduct any product recall, field correction or withdrawal of any Product in the Licensed Product within Territory that is not so required by such Regulatory Authorities but that Collaborator deems to be [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the TerritorySecurities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Cubist 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 controlhave the right, at its sole expense, to control all recalls 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, if such recall may reasonably have a material effect in the Licensed Product outside the TerritoryTerritory but such information is not otherwise required to be provided pursuant to Section 4.9(a). Chiron Collaborator shall maintain complete and accurate records of any recall in the Licensed Territory for such periods as may be required by legal requirementsapplicable Laws, but in any no event for no less than three (3) years. (b) In the event that any recall of Licensed Product in the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) of the License Agreement, 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 6.6(b) (and in Section 5.7(b) of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply to limit Chiron's remedies and Cubist's obligations or liabilities with respect to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 of the License 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 this 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 6.6(b) (and/or Section 5.7(b) of the License Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures ("SOPS"“SOPs”) as to for conducting product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of First Commercial Launch Sale of any Licensed Product in the Licensed 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 Licensed Product indicating that it indicates that a unit or batch of Finished Product or Bulk Hematide may not conform to the Specifications for Licensed Product then in effectspecifications therefor, or that there are potential adulteration, misbranding misbranding, and/or other issues regarding have arisen that relate to the safety or effectivenessefficacy of Products, it shall promptly so notify the other Party. The JCT Joint Committee shall meet to discuss such circumstances and to consider appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> 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 6.64.11. Except Collaborator shall have the right and responsibility to control any product recall, field correction, or withdrawal of any Product in the Licensed 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 a manufacturing defect in accordance with then prevailing U.S. product liability Laws, unless otherwise agreed upon by the Parties in the Supply Agreement (as defined in Section 7.3 hereof) for Bulk Hematide, then Affymax shall bear all such expenses, (ii) if the recall is due to a 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 Hematide), then Collaborator 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, 100% to Collaborator to the extent attributable to a recall in the Licensed Territory, unless otherwise provided may be agreed in Section 6.6(b) belowthe Supply Agreement. In addition, Chiron Collaborator shall controlhave the right, at its sole expensediscretion, all recalls to conduct any product recall, field correction or withdrawal of any Product in the Licensed Product within Territory that is not so required by such Regulatory [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Authorities but that Collaborator deems to be appropriate, with the Territoryallocation of expenses incurred in connection with such recall between the Parties to be as set forth in the immediately preceding sentence. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron Collaborator shall maintain complete and accurate records of any recall in the Licensed Territory for such periods as may be required by legal requirementsapplicable Laws, but in any no event for no less than three (3) years. (b) In the event that any recall of Licensed Product in the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) of the License Agreement, 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 6.6(b) (and in Section 5.7(b) of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply to limit Chiron's remedies and Cubist's obligations or liabilities with respect to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 of the License 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 this 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 6.6(b) (and/or Section 5.7(b) of the License Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures ("SOPSSOPs") as to for conducting product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of Commercial Launch of any Licensed Product in the GSK Territory, and shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after exchange, via their participation in the Clinical Development Committee. If either Party becomes aware of information about relating to any Licensed Product indicating that it indicates that a unit or batch of such product supplied to GSK pursuant to the Clinical Supply Agreement or Commercial Supply Agreement may not conform to the Specifications specifications for Licensed Product such product then in effecteffect pursuant to the applicable such agreement, or that there are potential adulteration, misbranding and/or other issues regarding have arisen that relate to the safety or effectivenessefficacy of Licensed Products, it shall promptly so notify the other Party. The JCT Joint Committee shall meet to discuss such circumstances and to consider appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> 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 6.64.8. Except as may be otherwise set forth in the Clinical Supply Agreement or Commercial Supply Agreement in relation to the extent otherwise provided in Section 6.6(b) below, Chiron shall control, at its sole expense, all recalls responsibilities of the Third Party suppliers supplying Licensed Product within or bulk ADV to Gilead, GSK shall [ * ] any product recall, field correction or withdrawal of any Licensed Product in the GSK Territory. Cubist The [ * ] with such product recalls, field corrections or withdrawals shall control[ * ] with the Clinical Supply Agreement and the Commercial Supply Agreement (as applicable) as appropriate in view of whether [ * ] As between the Parties, at its sole expenseGilead shall [ * ] all recalls, all recalls field corrections and withdrawals of any Licensed Product outside in the Gilead Territory. Chiron GSK shall maintain complete and accurate records of any recall in the GSK Territory for such periods as may be required by applicable legal requirements, but in any event for no less than three (3) years. (b) In the event that any recall of Licensed Product in the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) of the License Agreement, 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 6.6(b) (and in Section 5.7(b) of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply to limit Chiron's remedies and Cubist's obligations or liabilities with respect to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 of the License 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 this 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 6.6(b) (and/or Section 5.7(b) of the License Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7.[ * ]

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures ("SOPS"“SOPs”) as to for conducting product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date First Commercial Sale of Commercial Launch of any Licensed Product in the Licensed 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 Licensed released Product indicating that it indicates that a unit or batch of Product may not conform to the Specifications for Licensed Product then in effectspecifications thereof, or that there are potential adulteration, misbranding misbranding, and/or other issues regarding have arisen that relate to the safety or effectivenessefficacy of such released Product, it shall promptly so notify the other Party. The JCT To the extent Takeda requires such information to comply with applicable Laws or to determine whether to conduct a recall, AMAG shall meet promptly disclose to discuss the CMC Recipients any CMC Information related to such circumstances and nonconformance, adulteration, misbranding or other related issue. Takeda shall have the right, at its expense (except as provided herein), to consider appropriate courses control any Product recall, field correction, or withdrawal of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> courses of action any released Product in the applicable jurisdiction in the Licensed Territory; provided that prior to Takeda’s becoming Regulatory Lead with respect to EMA, Swissmedic and Health Canada, and for each recall country that the Parties agree that AMAG shall be consistent with the internal SOP Regulatory Lead, in each case pursuant to Section 5.2, AMAG shall have the right to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction and AMAG shall have the right to notify Takeda and request that such action be taken as a result of the manufacture of the Product. AMAG shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product outside the Licensed Territory. AMAG shall be responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the Licensed Territory to the extent such event of recall, field correction, or withdrawal is due to the breach by AMAG of this Agreement or the Supply Agreement. Takeda shall be responsible for all other costs incurred for any recall, field correction, or withdrawal of any released Product for the Licensed Territory. The procedures and consequences of such recalls shall be defined in the Supply Agreement. The Party having the right to control such recall pursuant to this Section 6.6. Except to the extent otherwise provided in Section 6.6(b) below, Chiron shall control7.4 may, at its sole expensediscretion, all recalls take appropriate courses of Licensed Product within action, which shall be consistent with the Territoryinternal SOPs of such Party; provided, however, that such controlling Party shall promptly notify the other Party of any recall action being considered and where practicable, consider the views of the non-controlling Party prior to taking any recall action. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron Takeda shall maintain complete and accurate records of any recall according to its then current SOPs in the Licensed Territory for such periods as may be required by legal requirementsapplicable Laws, but in any no event for no less than three (3) years. (b) In the event that any recall of Licensed Product in the Territory is required or necessary by virtue of such Licensed Product being Defective Manufactured Product, then both Parties shall work together to 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 terms of such plan, Chiron shall have the right, acting reasonably and in good faith, to adopt another plan), Chiron shall implement such recall in a manner consistent with the terms of 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) of the License Agreement, 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 6.6(b) (and in Section 5.7(b) of the License Agreement) on Cubist's responsibility for Recall Expenses shall not apply to limit Chiron's remedies and Cubist's obligations or liabilities with respect to matters other than Recall Expenses, including, without limitation, (i) Cubist's obligation to indemnify Chiron pursuant to Sections 10.1 and 10.3 of the License 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 this 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 6.6(b) (and/or Section 5.7(b) of the License Agreement), including, without limitation, the costs and expenses associated with notification and destruction and/or return of such recalled Licensed Product. 6.7.