Common use of Product Withdrawals and Recalls Clause in Contracts

Product Withdrawals and Recalls. In the event that (a) an event, incident, or circumstance has occurred which may result in the need for a recall or other removal of any Licensed Product or any lot or lots thereof from the market in the Field in the Territory; (b) any Regulatory Authority in the Territory threatens or initiates any action to remove the Licensed Product from the market in the Field in the Territory; or (c) any Regulatory Authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent, regarding use of the Licensed Product in the Field in the Territory, Santarus shall promptly advise Shore in writing with respect thereto. Unless otherwise agreed by the Parties and subject to the Impax Sublicense Agreement, Santarus shall be responsible for conducting the recall or other removal from the market and neither CHRP nor Shore shall consent to the conduct of a recall or other removal of any Licensed Product from the market in the Territory without obtaining the prior written consent of Santarus, not to be unreasonably withheld, conditioned or delayed. Shore (and CHRP to the extent required by Applicable Law) shall, upon reasonable request by Santarus, assist Santarus in the conduct of any such recall or removal from the market in the Territory, which recall or removal shall be controlled by Santarus in Santarus’ sole discretion. Subject to any obligations under ARTICLE 11, to the extent any recall or removal of a Licensed Product is implemented as a result of lots Manufactured prior to the Effective Date, Shore shall bear all reasonable costs incurred in connection with such recall or removal to the extent it is responsible for such lots under Section 6.2 with respect to Licensed Product returns (including all of Santarus’ reasonable out-of-pocket costs); otherwise (subject to the Impax Sublicense Agreement), Santarus shall bear all of Santarus’ costs, all of Shore’s reasonable out-of-pocket costs, and all other reasonable costs incurred in connection with such recall.

Product Withdrawals and Recalls. In the event that any Regulatory Authority (a) an event, incident, or circumstance has occurred which may result in the need for a recall or other removal of any Licensed Product or any lot or lots thereof from the market in the Field in the Territory; (b) any Regulatory Authority in the Territory threatens or initiates any action to remove the Licensed Product from the market in the Field in the Territory; or (c) any Regulatory Authority country in the Territory or (b) requires distribution of Procaps or its Affiliates to distribute a “Dear Doctor” letter or its equivalent, equivalent regarding use of the Licensed Product in the Field Field, Procaps shall notify Galectin Therapeutics and the JSMC of such event within one (1) business day after Procaps becomes aware of the action, threat, or requirement (as applicable). The JSMC shall immediately evaluate the request of such Regulatory Authority prior to initiating a recall or withdrawal of the Product in Colombia; provided, however, the TerritoryJSMC shall review the recall information and medical data within five (5) business days. If the JMSC does not reach and agreement within five (5) business days the final decision as to whether to recall or withdraw the Product or take other remedial action in Colombia pursuant to Section 3.6, Santarus shall promptly advise Shore in writing with respect theretowill be the responsibility of the CMO of Galectin Therapeutics. Unless otherwise agreed by Galectin Therapeutics will be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action if the Parties and subject recall is related to the Impax Sublicense Compound. If the recall or remedial action is the result of Procaps process, quality, fill and finish or marketing or violation of any laws, regulations, rules or guidelines or the breach of this Agreement, Santarus Procaps shall be responsible for conducting the recall or other removal from the market and neither CHRP nor Shore shall consent to the conduct expense of a recall or other removal of any Licensed Product from the market in the Territory without obtaining the prior written consent of Santarus, not to be unreasonably withheld, conditioned or delayed. Shore (and CHRP to the extent required by Applicable Law) shall, upon reasonable request by Santarus, assist Santarus in the conduct of any such recall or removal from remedial action. Procaps shall maintain complete distribution records by Purchaser, and by unique patient code and batch number for all Product Marketed and Distributed within the market Territory in accordance with Galectin Therapeutics’ procedures and instructions. If either Party becomes aware of information about the Territory, which recall or removal shall be controlled by Santarus in Santarus’ sole discretion. Subject to any obligations under ARTICLE 11, Product indicating that it may not conform to the extent any specifications for the Product, or that there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, it shall promptly so notify the other Party. The Parties shall discuss such circumstances and consider appropriate courses of action. Galectin Therapeutics shall control all recalls of Product. Each Party will maintain complete and accurate recall or removal of a Licensed Product is implemented as a result of lots Manufactured prior records relating to the Effective DateProduct for any periods that are required by applicable laws, Shore shall bear all reasonable costs incurred in connection with such recall rules or removal regulations. Portions of this Exhibit were omitted, as indicated by [****], and have been provided separately to the extent it is responsible for such lots under Section 6.2 with respect to Licensed Product returns (including all Secretary of Santarus’ reasonable out-of-pocket costs); otherwise (subject the Commission pursuant to the Impax Sublicense Agreement)Company’s application requesting confidential treatment under Rules 24b-2 of the Securities Exchange Act of 1934, Santarus shall bear all of Santarus’ costs, all of Shore’s reasonable out-of-pocket costs, and all other reasonable costs incurred in connection with such recallas amended.

Product Withdrawals and Recalls. In the event that (a) an event, incident, or circumstance has occurred which may result in the need for a recall or other removal of any Licensed the Product or any lot or lots thereof from the market in the Field in the Territory; (b) any Regulatory Authority in the Territory threatens or initiates any action to remove the Licensed Product from the market in the Field in the Territory; or (c) any Regulatory Authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent, regarding use of the Licensed Product in the Field in the Territory, Santarus Lilly shall promptly advise Shore United Therapeutics in writing with respect thereto, and shall provide to United Therapeutics copies of all relevant correspondence, notices, and any other related documents. Unless otherwise agreed by the Parties and subject to the Impax Sublicense AgreementParties, Santarus Lilly shall be responsible for conducting the recall. No recall or other removal from the market and neither CHRP nor Shore shall consent to the conduct of a recall or other removal of any Licensed Product from the market be commenced in the Territory without obtaining the Lilly’s prior written consent, such consent of Santarus, not to be unreasonably withheld, conditioned or delayed. Shore (and CHRP to the extent required by Applicable Law) United Therapeutics shall, upon reasonable request by Santarus, Lilly assist Santarus Lilly in the conduct of any such recall or removal from the market withdrawal in the Territory, which recall or removal withdrawal shall be controlled by Santarus Lilly in Santarus’ Lilly’s sole discretion. Subject to Each Party will cooperate with the other Party in the performance of any obligations under ARTICLE 11, to recall or withdrawal. To the extent any recall or removal of a Licensed the Product is implemented as a result of lots Manufactured prior Lilly’s fault or negligence, in addition to the Effective Dateany obligations under ARTICLE 12, Shore Lilly shall (i) bear all reasonable of Lilly’s costs and all Reasonable Costs incurred by United Therapeutics in connection with such recall and (ii) either, at its sole option, replace or removal credit United Therapeutics for the cost of the relevant lots of the Product subject to the recall. For any and all recalls of the Product in the Field in the Territory required to the extent it is responsible for such lots under Section 6.2 with respect due to Licensed Product returns (including all of Santarus’ reasonable out-of-pocket costs); otherwise (subject to the Impax Sublicense Agreement)any other reason, Santarus United Therapeutics shall bear all of SantarusUnited Therapeutics’ costs, all of Shorecosts and Lilly’s reasonable out-of-pocket costs, and all other reasonable costs Reasonable Costs incurred in connection with such recall.

Product Withdrawals and Recalls. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of Product Launch, and shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after such exchange. In the event of any disagreement as to how to resolve any such conflicts with respect to the Product, VIVUS ‘s SOP shall control unless and until VIVUS transfers ownership of the Product Marketing Authorization to Licensee, and Licensee’s SOP shall control thereafter. If either Party becomes aware of information relating to *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the Product that (a) an event, incidentindicates that a unit or batch of such Product may not conform to the specifications therefor, or circumstance has occurred which may result in that potential adulteration, misbranding, and/or other issues have arisen that relate to the need for a recall safety or efficacy of Products, it shall promptly so notify the other removal Party. To the extent practicable, the Parties shall discuss the circumstances of any Licensed potential product recall, field correction, or withdrawal of any Product and possible appropriate courses of action. If Licensee decides to initiate a recall, field correction, or any lot or lots thereof from the market in the Field in the Territory; (b) any Regulatory Authority in the Territory threatens or initiates any action to remove the Licensed Product from the market in the Field in the Territory; or (c) any Regulatory Authority in the Territory requires distribution withdrawal of a “Dear Doctor” letter or its equivalent, regarding use of the Licensed Product in the Field Licensee Territory, Licensee shall have the right and responsibility, at its expense but without limiting any claims Licensee may have against VIVUS or any other Person, to control such recall, field correction, or withdrawal in a manner consistent with its internal SOPs (as revised pursuant to the first sentence of this Section ‎5.5(c), if applicable); provided, however, Licensee shall consider in good faith the views of VIVUS as to whether a recall, field correction, or withdrawal is necessary or appropriate. For clarity, as between the Parties, VIVUS shall have the right, at its expense, to control all recalls, field corrections, and withdrawals of any Product in the VIVUS Territory, Santarus . Each Party shall promptly advise Shore in writing with respect thereto. Unless otherwise agreed by the Parties maintain complete and subject to the Impax Sublicense Agreement, Santarus shall be responsible for conducting the recall or other removal from the market and neither CHRP nor Shore shall consent to the conduct of a recall or other removal accurate records of any Licensed Product from the market recall, field correction, or withdrawal in the Territory without obtaining the prior written consent of Santarus, not to its territory for such periods as may be unreasonably withheld, conditioned or delayed. Shore (and CHRP to the extent required by Applicable Law) shallLaws, upon reasonable request but in no event for less than ***. For purposes of clarity, for Product supplied by SantarusVIVUS under the Commercial Supply Agreement, assist Santarus the Parties’ respective responsibilities for the costs of any Product recall, field correction, or withdrawal of such Product shall be as set forth in the conduct of any such recall or removal from the market in the Territory, which recall or removal shall be controlled by Santarus in Santarus’ sole discretion. Subject to any obligations under ARTICLE 11, to the extent any recall or removal of a Licensed Product is implemented as a result of lots Manufactured prior to the Effective Date, Shore shall bear all reasonable costs incurred in connection with such recall or removal to the extent it is responsible for such lots under Section 6.2 with respect to Licensed Product returns (including all of Santarus’ reasonable out-of-pocket costs); otherwise (subject to the Impax Sublicense Commercial Supply Agreement), Santarus shall bear all of Santarus’ costs, all of Shore’s reasonable out-of-pocket costs, and all other reasonable costs incurred in connection with such recall.