Common use of Recalls and Voluntary Withdrawals Clause in Contracts

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of 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 relating to any released Product that indicates that a unit or batch of Product may not conform to the specifications thereof, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released Product, it shall promptly so notify the other Party. To the extent Daewoong requires such information to comply with applicable Laws or to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio shall be responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the 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 9.8 may, at its sole discretion, take appropriate courses of action, which shall be consistent with the internal 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. 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 applicable Laws, but in no event for less than three (3) years.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting as to product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the First date of Commercial Sale 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 relating to about any released Licensed Product indicating that indicates that a unit or batch of Product it may not conform to the specifications thereoffor Licensed Product then in effect pursuant to the Supply Agreement, or that there are potential adulteration, misbranding, misbranding and/or other issues have arisen that relate to the regarding safety or efficacy of such released Producteffectiveness, it shall promptly so notify the other Party. To the extent Daewoong requires The JCT shall meet to discuss such information circumstances and to comply consider appropriate courses of action, which courses of action with applicable Laws or respect to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio each recall shall be responsible for all costs incurred for any recall, field correction, or withdrawal consistent with the internal SOP of any released Product for the 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 9.8 may5.7. Except to the extent otherwise provided in Section 5.7(b) below, Chiron shall control, at its sole discretionexpense, take appropriate courses all recalls of actionLicensed Product within the Territory. Cubist shall control, which shall be consistent with at its sole expense, all recalls of Licensed Product outside the internal 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 actionTerritory. Daewoong Chiron 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 applicable Lawslegal requirements, but in no 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), 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 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 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 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 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. (a) The Parties shall exchange their internal standard operating procedures (“SOPs”"SOPS") for conducting as to product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the First date of Commercial Sale 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 relating to about any released Licensed Product indicating that indicates that a unit or batch of Product it may not conform to the specifications thereofSpecifications for Licensed Product then in effect, or that there are potential adulteration, misbranding, misbranding and/or other issues have arisen that relate to the regarding safety or efficacy of such released Producteffectiveness, it shall promptly so notify the other Party. To the extent Daewoong requires The JCT shall meet to discuss such information circumstances and to comply consider appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 21 <Page> courses of action with applicable Laws or respect to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio each recall shall be responsible for all costs incurred for any recall, field correction, or withdrawal consistent with the internal SOP of any released Product for the 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 9.8 may6.6. Except to the extent otherwise provided in Section 6.6(b) below, Chiron shall control, at its sole discretionexpense, take appropriate courses all recalls of actionLicensed Product within the Territory. Cubist shall control, which shall be consistent with at its sole expense, all recalls of Licensed Product outside the internal 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 actionTerritory. Daewoong Chiron 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 applicable Lawslegal requirements, but in no 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.

Recalls and Voluntary Withdrawals. The Parties shall exchange and provide timely updates to their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of any 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 relating to any released Product that indicates that a unit or batch of Finished Product or Bulk API may not conform to the specifications thereoftherefor, or that potential adulteration, misbranding, and/or or other issues have arisen that relate to the safety or efficacy of such released the Product, it shall promptly so notify the other Party. To the extent Daewoong requires The JSC shall meet to discuss such information circumstances and to comply with applicable Laws or to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio shall be responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the 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 consider 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 9.8 may, at its sole discretion, take decide appropriate courses of action, which shall be consistent with the internal SOPs SOP of such Party; providedTakeda. The Party that holds the applicable Regulatory Approval shall have the right and responsibility to control any product recall, howeverfield correction, that such controlling Party shall promptly notify the other Party 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 action being considered 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 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 where practicable(ii), consider then the views 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 may be agreed for one or more territories in the Supply Agreement as described in Section 7.3. In addition, Takeda shall have the right, at its discretion, to conduct any product recall, field correction or withdrawal of any Product in the non-controlling Party prior Licensed Territory that is not so required by such Regulatory Authorities but that Takeda deems to taking any be appropriate, and the allocation of expenses incurred in connection with such recall actionbetween the Parties shall be as set forth in the immediately preceding sentence. Daewoong 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 applicable Laws, but in no event for less than three (3) years.

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“"SOPs”") for conducting product recalls reasonably in advance of the First Commercial Sale 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 such exchange, via their participation in the Clinical Development Committee. If either Party becomes aware of information relating to any released Licensed Product that indicates that a unit or batch of Product such product supplied to GSK pursuant to the Clinical Supply Agreement or Commercial Supply Agreement may not conform to the specifications thereoffor such product then in effect pursuant to the applicable such agreement, or that potential adulteration, misbranding, misbranding and/or other issues have arisen that relate to the safety or efficacy of such released ProductLicensed Products, it shall promptly so notify the other Party. To the extent Daewoong requires The Joint Committee shall meet to discuss such information circumstances and to comply with applicable Laws or to determine whether to conduct a recallconsider appropriate courses of action, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio which shall be responsible for all costs incurred for any recall, field correction, or withdrawal consistent with the internal SOP of any released Product for the 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 9.8 may4.8. Except as may be otherwise set forth in the Clinical Supply Agreement or Commercial Supply Agreement in relation to the responsibilities of the Third Party suppliers supplying Licensed Product or bulk ADV to Gilead, at its sole discretionGSK shall [ * ] any product recall, take appropriate courses field correction or withdrawal of actionany Licensed Product in the GSK Territory. The [ * ] with such product recalls, which field corrections or withdrawals shall be consistent [ * ] with the internal SOPs Clinical Supply Agreement and the Commercial Supply Agreement (as applicable) as appropriate in view of such Party; providedwhether [ * ] As between the Parties, howeverGilead shall [ * ] all recalls, that such controlling Party shall promptly notify the other Party field corrections and withdrawals of any recall action being considered and where practicable, consider Licensed Product in the views of the non-controlling Party prior to taking any recall actionGilead Territory. Daewoong GSK shall maintain complete and accurate records of any recall according to its then current SOPs in the GSK Territory for such periods as may be required by applicable Lawslegal requirements, but in no any event for no less than three (3) years.[ * ]

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of 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 relating to any released Product that indicates that a unit or batch of Product may not conform to the specifications thereof, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released Product, it shall promptly so notify the other Party. To the extent Daewoong Takeda requires such information to comply with applicable Laws or to determine whether to conduct a recall, Ampio AMAG shall promptly disclose to Daewoong the CMC Recipients any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong Takeda shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of 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 country that the Parties agree that AMAG shall be the 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. Ampio AMAG shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in outside the Retained Licensed Territory. Ampio 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 material breach by Ampio AMAG of this Agreement or the Supply Agreement. Daewoong 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 9.8 7.4 may, at its sole discretion, take appropriate courses of action, which shall be consistent with the internal 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. Daewoong 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 applicable Laws, but in no event for less than three (3) years.

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of any 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 relating to any released Product that indicates that a unit or batch of Finished Product or Bulk Hematide may not conform to the specifications thereoftherefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released ProductProducts, it shall promptly so notify the other Party. To the extent Daewoong requires The Joint Committee shall meet to discuss such information circumstances and to comply with applicable Laws or to determine whether to conduct a recallconsider appropriate courses of action, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio which shall be responsible for all costs incurred for any recall, field correction, or withdrawal consistent with the internal SOP of any released Product for the 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 9.8 may4.11. 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 set forth in the Supply Agreement as described in Section 7.3. In addition, Collaborator shall have the right, at its sole discretion, take appropriate courses to conduct any product recall, field correction or withdrawal of actionany Product in the Licensed Territory that is not so required by such Regulatory Authorities but that Collaborator deems to be [ * ] = Certain confidential information contained in this document, which shall be consistent marked by brackets, has been omitted and filed separately with the internal SOPs Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. appropriate, with the allocation of expenses incurred in connection with such Party; 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 controlling Third Party shall promptly notify Partner, use reasonable efforts to secure its right to inform Collaborator of such event) to inform the other Party Collaborator of any such intention in advance in writing, if such recall action being considered and where practicable, consider may reasonably have a material effect in the views of the non-controlling Party prior Licensed Territory but such information is not otherwise required to taking any recall actionbe provided pursuant to Section 4.9(a). Daewoong Collaborator 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 applicable Laws, but in no event for less than three (3) years.

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of any 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 relating to any released Product that indicates that a unit or batch of Finished Product or Bulk Hematide may not conform to the specifications thereoftherefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released ProductProducts, it shall promptly so notify the other Party. To the extent Daewoong requires The Joint Committee shall meet to discuss such information circumstances and to comply with applicable Laws or to determine whether to conduct a recallconsider appropriate courses of action, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio which shall be responsible for all costs incurred for any recall, field correction, or withdrawal consistent with the internal SOP of any released Product for the 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 9.8 may4.11. 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 may be agreed in the Supply Agreement. In addition, Collaborator shall have the right, at its sole discretion, take appropriate courses to conduct any product recall, field correction or withdrawal of actionany Product in the Licensed Territory that is not so required by such Regulatory [ * ] = Certain confidential information contained in this document, which shall be consistent marked by brackets, has been omitted and filed separately with the internal SOPs of such Party; provided, however, that such controlling Party shall promptly notify the other Party of any recall action being considered Securities and where practicable, consider the views Exchange Commission pursuant to Rule 24b-2 of the non-controlling Party prior Securities Exchange Act of 1934, as amended. Authorities but that Collaborator deems to taking any be appropriate, with the allocation of expenses incurred in connection with such recall actionbetween the Parties to be as set forth in the immediately preceding sentence. Daewoong Collaborator 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 applicable Laws, but in no event for less than three (3) years.

Recalls and Voluntary Withdrawals. The Parties JSC shall exchange their assign responsibility to TGTX for providing its internal standard operating procedures (“SOPs”) for conducting any recall, field alert, product recalls withdrawal or other field action relating to the finished product reasonably in advance of the First Commercial Sale of any Product in the Territory, and shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after such exchangeTerritory to the other party. If either Party becomes aware of information relating to any released Product that indicates that a unit or batch of Finished Product or Bulk API may not conform to the specifications thereoftherefor, or that potential adulteration, misbranding, and/or or other issues have arisen that relate to the safety or efficacy of such released the Product, it shall promptly so notify the other Party. To the extent Daewoong requires The JSC shall meet to discuss such information circumstances and to comply with applicable Laws or to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio shall be responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the 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 consider 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 9.8 may, at its sole discretion, take decide appropriate courses of action, which shall be consistent with the internal SOPs SOP of such Party; providedTGTX, howeverTGTX shall have the right and responsibility to control any product recall, that such controlling Party shall promptly notify the other Party 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 action being considered 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 where practicableapplicable laws, consider then Rhizen shall bear all such expenses, (ii) if the views recall is primarily due to a failure by TGTX to comply with its obligation under this agreement or the commercial supply agreement, including with respect to the labeling, possession, storage or distribution of the non-controlling Party prior finished product, then TGTX shall bear all such expenses, and (iii) otherwise, such expenses shall be treated as Commercial Expenses. In addition, TGTX shall have the right, at its discretion, to taking conduct any product recall, field correction or withdrawal of any Product in the Territory 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 actionbetween the Parties shall be as set forth in the immediately preceding sentence. Daewoong TGTX 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 applicable Laws, but in no event for less than three (3) years. If the parties are unable to agree on which party is responsible for the cost of the recall pursuant to this section 4.7, the parties agree to submit a sample of the finished product to an independent third party analyst to determine the cause of the defect. The cost of the report of the independent analyst will be paid by the party against which the report is unfavorable.

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of any 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 relating to any released Product that indicates that a unit or batch of Finished Product or Bulk Hematide may not conform to the specifications thereoftherefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released ProductProducts, it shall promptly so notify the other Party. To the extent Daewoong requires The Joint Committee shall meet to discuss such information circumstances and to comply with applicable Laws or to determine whether to conduct a recallconsider appropriate courses of action, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio which shall be responsible for all costs incurred for any recall, field correction, or withdrawal consistent with the internal SOP of any released Product for the 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 9.8 may4.11. 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 may be agreed in the Supply Agreement. In addition, Collaborator shall have the right, at its sole discretion, take appropriate courses to conduct any product recall, field correction or withdrawal of actionany Product in the Licensed Territory that is not so required by such Regulatory [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, which shall 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 consistent appropriate, with the internal SOPs allocation of expenses incurred in connection with such Party; provided, however, that such controlling Party shall promptly notify recall between the other Party of any recall action being considered and where practicable, consider Parties to be as set forth in the views of the non-controlling Party prior to taking any recall actionimmediately preceding sentence. Daewoong Collaborator 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 applicable Laws, but in no event for less than three (3) years.

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of 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 relating to any released Product that indicates that a unit or batch of Product may not conform to the specifications License, Development and Commercialization Agreement between Ampio and Daewoong thereof, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released Product, it shall promptly so notify the other Party. To the extent Daewoong requires such information to comply with applicable Laws or to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio shall be responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the 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 9.8 may, at its sole discretion, take appropriate courses of action, which shall be consistent with the internal 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. 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 applicable Laws, but in no event for less than three (3) years.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures (“SOPs”"SOPS") for conducting as to product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the First date of Commercial Sale 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 relating to about any released Licensed Product indicating that indicates that a unit or batch of Product it may not conform to the specifications thereofSpecifications for Licensed Product then in effect, or that there are potential adulteration, misbranding, misbranding and/or other issues have arisen that relate to the regarding safety or efficacy of such released Producteffectiveness, it shall promptly so notify the other Party. To the extent Daewoong requires The JCT shall meet to discuss such information circumstances and to comply consider appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION courses of action with applicable Laws or respect to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio each recall shall be responsible for all costs incurred for any recall, field correction, or withdrawal consistent with the internal SOP of any released Product for the 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 9.8 may6.6. Except to the extent otherwise provided in Section 6.6(b) below, Chiron shall control, at its sole discretionexpense, take appropriate courses all recalls of actionLicensed Product within the Territory. Cubist shall control, which shall be consistent with at its sole expense, all recalls of Licensed Product outside the internal 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 actionTerritory. Daewoong Chiron 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 applicable Lawslegal requirements, but in no 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.