Common use of Product Recall Clause in Contracts

Product Recall. 15.1 Product may be recalled by XDx for any of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory Authority; or (C) where XDx determines that recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach of this Agreement by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records of the Distribution of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall of any Product is required.

Product Recall. 15.1 16.1 Subject to Section 16.5, if any Product may be is recalled by XDx for any reason, including because of a legal or regulatory requirement or order to recall, or at the request of AstraZeneca pursuant to Section 16.3, (i) AstraZeneca shall be responsible for such Product recall including the overall management of the following reasons: (A) where issue and circumstances giving rise to the recall of the Product including dealing with Regulatory Authorities in this regard, except as required by Applicable Laws applicable Law and Regulations; (Bii) following an order to recall by any Regulatory Authority; or (C) where XDx determines that recall is necessary or advisable for safety reasons. Diaxonhit Prometheus shall administer all aspects of any conduct such Product recall on behalf of AstraZeneca, in each case in accordance with the provisions of this clause 15Article 16. 15.2 16.2 If Diaxonhit determines that any Product should be recalleda recall is requested by AstraZeneca, or if Diaxonhit becomes aware that a recall is required by lawapplicable Law, then Diaxonhit AstraZeneca shall notify XDx Prometheus in writing within twenty-four (24) hours of such determination and shall consult with XDx Prometheus regarding the most appropriate course of actionaction (or if Prometheus receives first notice of a recall, it shall notify AstraZeneca in writing within twenty-four (24) hours of such receipt). XDx Prometheus shall review the written notice and provide a written response to Diaxonhit AstraZeneca within twenty-four one (241) hours Business Day of receipt of Diaxonhit’s AstraZeneca's notice of such determination. Diaxonhit shall give XDx notice of any , provided that, in a life endangering situation or requirement for in the event of a recall of any Product mandated by applicable Law or action of any Regulatory Authority Authorities of which Prometheus is provided notice, Prometheus shall be permitted to initiate a recall without obtaining the prior approval of AstraZeneca. Prometheus shall, however, use Diligent Efforts to notify AstraZeneca of such situation immediately, and Prometheus shall provide AstraZeneca with full details of such situation promptly, so that the Parties may decide on the most appropriate course of action. 15.3 If XDx 16.3 Subject to Section 16.2, if AstraZeneca determines that any Product should be recalled because of due to safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit Prometheus shall proceed with the recall in accordance with Diaxonhit’s Prometheus' recall procedures and any reasonable instructions provided by XDxprocedures. 15.4 16.4 Following the decision to recall any Product, XDx AstraZeneca shall also provide Diaxonhit Prometheus with a prepared statement for use (subject to Prometheus approval, such approval not to be unreasonably withheld) in response to any inquiries regarding any recall of the Product. Diaxonhit Prometheus shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recallrecall except as required by applicable Law. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if 16.5 If any Product is recalledrecalled by the FDA or AstraZeneca, XDx AstraZeneca shall reimburse Diaxonhit Prometheus for the direct reasonable out-of-pocket costs of activities incurred by Prometheus as a direct result of the recall, (e.g., travel, transportation, destruction and publicity costs) except ), including those internal costs directly incurred and necessary to administer the recall. AstraZeneca shall provide Prometheus with a Credit Note equal to the Purchase Price for any such recalled Product; provided, however, that XDx AstraZeneca shall not reimburse any costs associated with the recall or issue any Credit Note with regard to recalled Product to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit Prometheus or any of Diaxonhit’s Affiliates or Sales Agents, or their its directors, officers, employees or agents or due to a breach of this Agreement by DiaxonhitPrometheus (a "Prometheus Fault"). In addition, if any Product is recalled by the FDA or AstraZeneca, then, upon Prometheus' written request, AstraZeneca shall supply replacement Product to Prometheus as expeditiously as commercially practicable at the same price that Prometheus would have paid for the defective Product. 15.6 In addition to its obligations under clause 2.7, Diaxonhit 16.6 Prometheus shall keep complete and accurate records of the Distribution distribution and sales of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, Product to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall of any Product is required. 16.7 AstraZeneca shall be entitled to inspect and audit (pursuant to Section 30.4) Prometheus' recall procedures and the records referred to in Section 16.6, to ensure that Prometheus is complying with all applicable Laws. However, this Section 16.7 shall not relieve Prometheus of its responsibilities and liabilities arising under this Article 16 16.8 In the event of a recall, the obligations of the Parties under the Agreement will be suspended, as appropriate, until the circumstances that caused the recall have been resolved (including regulatory authorization to resume is received, if applicable). 16.9 For the avoidance of doubt, Prometheus' obligations pertaining to recalls under this Article 16 apply only to the extent that the recall is in the Territory. In addition, AstraZeneca will promptly notify Prometheus of any recall relating to the Product that occurs or is reasonably likely to occur outside of the Territory.

Product Recall. 15.1 Product may be recalled by XDx for any of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by If any Regulatory Authority; or (C) where XDx determines that recall is necessary Authority in the Territory orders or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding requires the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasonsin the Territory, XDx shall or if in GSK's opinion a recall is necessary in the Territory, GSK will promptly notify Diaxonhit in writing within twenty four (24) hours of ALLERGAN and provide such determination and the reason for information regarding such recall order or other information as may be reasonably requested by ALLERGAN. GSK shall, unless prohibited by applicable law, consult with ALLERGAN on the need for a recall and Diaxonhit take all ALLERGAN submissions into account when making a decision whether to instigate a recall (such decision not to be unreasonably made). GSK shall proceed be responsible for conducting any recall of Product in the Territory and ALLERGAN shall co-operate with GSK by providing all such information and assistance as may be reasonably required to implement such recall. To the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding extent that any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred implemented as a result of ALLERGAN's failure to Manufacture Product in accordance with the terms and conditions of this Supply Agreement, ALLERGAN shall (i) bear all direct expenses incurred by GSK in connection with such recall, (e.g.ii) shall indemnify the GSK Indemnitees (as defined in Section 7.1) from any and all Liabilities (as defined in Section 7.1) incurred by any GSK Indemnitee, travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such these are proven to be attributable to ALLERGAN's failure to Manufacture Product in accordance with the terms and conditions of this Supply Agreement and (iii) shall either, at GSK's sole option, replace or credit GSK for the cost of the relevant Lots of the Product subject to the recall. If a recall of Product is required due to the faultany negligence or willful misconduct of a GSK Indemnitee, negligence, recklessness or wrong-doing of Diaxonhit or including without limitation any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or recall that could have been avoided but was not avoided due to a breach failure of this Agreement GSK to perform the testing allowed by Diaxonhit. 15.6 In addition to its obligations under clause 2.7Section 5.6, Diaxonhit GSK shall keep complete bear all such costs and accurate records of expenses incurred in connection with such recall and shall indemnify the Distribution of the Product, including methods for tracking ALLERGAN Indemnitees from and traceability as required under Applicable Laws against any and Regulations, to enable appropriate procedures all Liabilities incurred by an ALLERGAN Indemnitee that are proven to be implemented in attributable solely to the event that a voluntary negligence or mandatory willful misconduct of GSK. If any Regulatory Authority outside the Territory orders or requires the recall of any Product is requiredof the Products outside the Territory then ALLERGAN will promptly notify GSK and provide such information regarding such recall order or other information as may be reasonably requested by GSK. EXCEPT AS SET FORTH IN ARTICLE 7 (INDEMNIFICATION), EACH PARTY'S SOLE AND EXCLUSIVE REMEDIES FOR RECALLED PRODUCT SHALL BE LIMITED TO THE REMEDIES PROVIDED IN THIS SECTION AND, IF RELEVANT, THE REMEDIES FOR FAILURE TO SUPPLY SET OUT IN THE LICENSE AGREEMENT.

Product Recall. 15.1 Product may be recalled by XDx for any of Schering-Plough will review with Centocor the following reasons: (A) where required by Applicable Laws Schering-Plough product recall procedures and Regulations; (B) following an order Schering-Plough agrees to recall by any Regulatory Authority; or (C) where XDx determines that recall is necessary or advisable for safety reasonsmaintain and to implement the same, subject to the provisions herein. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall Schering-Plough and Centocor have the responsibility to notify XDx in writing each other within twenty-four (24) hours of a situation which could lead to a recall or withdrawal of the Product in the Territory. Within forty-eight (48) hours after such determination notice, the parties' representatives from business, medical, regulatory, quality assurance and legal functions, and any others deemed necessary (the "Recall Team"), will consult to determine if any Product shall be withdrawn or recalled from the market. If the Recall Team agrees to conduct a recall, then the Recall Team shall also consult with XDx regarding respect to the most appropriate course timing of actionthe recall, the breadth, extent and level of customer to which the recall shall reach, and what strategies and notifications should be used. XDx shall review the written notice and provide a written response If agreement as to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for whether a recall should be conducted cannot be reached between the Schering-Plough and Centocor representatives on the Recall Team, the Oversight Committee shall be immediately consulted. If the Oversight Committee cannot agree, then the party holding the marketing authorizations for the Product in the Territory shall have final decision making authority with respect to any recall in the Territory and Centocor shall have final decision making authority with respect to countries outside the Territory. The license holder for the Product will be responsible for formal notification of the regulatory authorities; however, Centocor and Schering-Plough will coordinate with each other on the notification of regulatory authorities. In the Territory, Schering-Plough will be responsible to implement any Product mandated by any Regulatory Authority promptlywithdrawal or recall from the market. 15.3 If XDx determines (a) In the event that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx or withdrawal occurs in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred Territory as a result of adverse event or other safety reasons for which neither Centocor nor Schering-Plough are at fault, the recallparties shall share equally all reasonable costs and expenses of such Product recall or withdrawal in the Territory, (e.g.including, travelwithout limitation, transportationthe expenses incurred for the investigation, notification, regulatory reporting, destruction and publicity costs) except those internal and/or return of the recalled Product, the cost of the manufactured Product recalled, Schering-Plough's costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall relating to the extent testing, packaging, shipping and supplying the Product recalled, expenses or obligations to third parties, and the cost of notifying users (hereinafter the "Recall Expenses"). For purposes of calculating Recall Expenses under this Section 5.6(a) and under Sections 5.6(b) and (c), Centocor shall issue a credit to Schering-Plough for the full cost paid by Schering-Plough to Centocor for the manufactured Product recalled, and that such recall is due cost of the manufactured Product recalled shall be included in Recall Expenses at Centocor's cost of goods. Centocor and Schering-Plough each acknowledge that the obligations of the other under this Section do not extend to the faultexpenses or obligations of either to third parties or to any claim by either for loss of anticipated profits, negligencegoodwill, recklessness reputation, business receipts or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agentscontracts, or their directorslosses or expenses resulting from third party claims or for any indirect or consequential losses suffered by either, officershowsoever caused, employees and each hereby waives any claim to such expenses or agents losses or due to which may arise as a result of any such obligations. (b) In the event that any Product recall occurs as a result of (i) a breach of this Agreement by DiaxonhitCentocor, or (ii) any wrongful act or omission whether negligent or otherwise of Centocor, Centocor will bear all reasonable Recall Expenses incurred by Schering-Plough. Recall Expenses under this Section 5.6(b) shall be calculated as set forth in Section 5.6(a). Schering-Plough acknowledges that Centocor's obligations under this Section do not extend to expenses or obligations of Schering-Plough to third parties or to any claim by Schering-Plough for loss of anticipated profits, goodwill, reputation, business receipts or contracts, or losses or expenses resulting from third party claims or for any indirect or consequential losses suffered by Schering-Plough, howsoever caused, and hereby waives any claim to such expenses or losses or which may arise as a result of any such obligations. 15.6 (c) In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records of the Distribution of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that any Product recall occurs as a voluntary result of (i) a breach of this Agreement by Schering-Plough, or mandatory recall (ii) any wrongful act or omission, whether negligent or otherwise of Schering-Plough, Schering-Plough will bear all reasonable Recall Expenses incurred by Centocor. Recall Expenses under this Section 5.6(c) shall be calculated as set forth in Section 5.6(a). Centocor acknowledges that Schering-Plough's obligations under this Section do not extend to expenses or obligations of Centocor to third parties or to any claim by Centocor for loss of anticipated profits, goodwill, reputation, business receipts or contracts, or losses or expenses resulting from third party claims or for any indirect or consequential losses suffered by Centocor, howsoever caused, and hereby waives any claim to such expenses or losses or which may arise as a result of any Product is requiredsuch obligations.

Product Recall. 15.1 Product may be recalled by XDx for any of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory Authority; or (C) where XDx determines If either party believes that a product recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalledappropriate, or if Diaxonhit becomes aware that a it will promptly notify the other, and the parties will (unless such recall is required by law) discuss whether such recall is necessary or appropriate, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding discuss the most appropriate course of actionmanner in which any agreed or required recall shall be conducted. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for If a recall of any Product mandated is not required by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination law and the reason for such parties cannot agree whether the recall and Diaxonhit shall proceed with is necessary or appropriate, either party may elect to conduct the recall in accordance question The parties shall cooperate with Diaxonhit’s recall procedures and each other in conducting any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap . All out of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities a required or agreed recall insofar as such recall relates to Critical Reagents (except printing and mailing costs incurred to notify customers of such recall), shall be borne by Ostex. All out of pocket costs of a required or agreed recall except insofar as such recall relates to Critical Reagents or the NTx Assay Technology ( except printing and mailing costs incurred to notify customers of such recall), shall be borne by Hologic. All costs of a result of recall to which the parties have not agreed shall be borne by the party that elects to conduct the recall, provided that if a court of competent jurisdiction determines that said recall was caused by (e.g.i) the fact that any Critical Reagents or the NTx Assay Technology were in violation of applicable law or the terms of this contract, travel, transportation, destruction Hologic may obtain reimbursement by Ostex of all reasonable out of pocket costs and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that expenses of such recall is due (except for printing and mailing costs incurred to the fault, negligence, recklessness or wrong-doing notify customers of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agentssuch recall), or their directors, officers, employees (ii) the fact that any NTx Meter or agents NTx Meter Strip(s) were otherwise in violation of applicable law or due to a breach the terms of this Agreement contract, Ostex may obtain reimbursement by Diaxonhit. 15.6 In addition Hologic of all reasonable out of pocket costs and expenses of such recall (except for printing and mailing costs incurred to its obligations under clause 2.7, Diaxonhit notify customers of such recall. Each party shall keep maintain complete and accurate records of the Distribution of the Product, including methods all product sold by it for tracking and traceability such periods as required under Applicable Laws and Regulations, by law. Nothing in this Section shall be construed to enable appropriate procedures modify or limit any legal obligation of either party with respect to be implemented in the event that a voluntary or mandatory recall of any Product is requiredrecall.

Product Recall. 15.1 Product may be recalled by XDx for 12.1 Each Party shall promptly inform the other Party of any notification of the following reasons: any action by, or notification or other information which it receives (Adirectly or indirectly) where required by Applicable Laws and Regulations; (B) following an order to recall by from any Regulatory Authority; or , which (Ca) where XDx determines that raises any concerns regarding the safety or efficacy of the Licensed Product in the Field, or (b) indicates a reasonable likelihood for a recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects market withdrawal of any the Licensed Product recall in accordance with provisions of this clause 15the Field. 15.2 If Diaxonhit determines 12.2 In the event that (a) any Regulatory Authority issues a recall or takes similar action (a “Recall”) in connection with the Licensed Product should be recalledsold or distributed by Orion in the Territory, or if Diaxonhit becomes aware that (b) a recall is required by lawcourt of competent jurisdiction orders such a Recall, then Diaxonhit Orion shall notify XDx in writing within twenty-four (24) hours inform Indevus of such determination and Recall, the Parties shall consult with XDx regarding each other with respect thereto and Orion shall consider in good faith any comments or suggestions of Indevus, provided, however, that nothing herein shall prohibit Orion from initiating or conducting any Recall that it reasonably believes is required in the most appropriate course Territory. 12.3 In the event Orion believes there is a possible safety risk with respect to Licensed Product and, as a result thereof, wishes to cease distribution and/or sales of action. XDx the Licensed Product in the Territory, it shall review the written notice inform Indevus of its belief and provide a written response such information with respect thereto as Indevus shall request, and the Parties shall in good faith consider the matter and each others views with respect thereto. 12.4 Except as set forth above, Orion shall have responsibility for and shall make all decisions relating to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of conducting any life endangering situation or requirement for a recall of any Product Recall mandated by any Regulatory Authority promptly. 15.3 If XDx determines that related to Licensed Product in the Field in the Territory and Orion shall undertake such actions in a manner designed to minimize any harm to the marketability of Licensed Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and or the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall reputation of the ProductParties. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occursAt Orion’s request, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent a Recall or market withdrawal implicates Bulk Drug Product and/or Insertion Tools supplied by Indevus to Orion, Indevus shall provide reasonable assistance in conducting such Recall or market withdrawal including providing pertinent manufacturing records that Orion may reasonably request to assist in effecting such recall is due action. In any event, Orion shall keep Indevus informed with respect to the faultstatus of any Recall or market withdrawal in the Territory and Indevus shall have the right to participate, upon its request, in any statements relating to any such Recall or market withdrawal to the extent feasible under the circumstances. 12.5 Except as expressly otherwise provided in this Article 12, Orion shall bear all costs of a Recall, marketing withdrawal or other corrective action with respect to Licensed Product in the Field in the Territory. Notwithstanding the foregoing, Indevus shall bear such costs if such Recall, market withdrawal or other corrective action (a) is attributable to the fault of Indevus; (b) results from the negligence, recklessness or wrong-doing intentional misconduct on the part of Diaxonhit Indevus or any of Diaxonhit’s its Affiliates or Sales Agentssubcontractors (and not from the negligence, recklessness or their directorsomission or intentional misconduct on the part of Orion or any of its Affiliates, officers, employees sublicensees or agents Marketing Distributors) or due to a breach of this Agreement by DiaxonhitIndevus or its Affiliates or subcontractors (and not from breach of this Agreement by Orion or any of its Affiliates, sublicensees or Marketing Distributors); or (c) is attributable to the failure of Bulk Drug Product and/ Insertion Tools supplied by Indevus to comply with the Agreed Quality. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records of the Distribution of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall of any Product is required.

Product Recall. 15.1 Product may If at any time (a) any governmental agency having jurisdiction provides written notice to either ACBL or Seller, or (b) either ACBL or Seller have a reasonable basis to conclude that any Item(s) contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement, thereby making it advisable, or required, that such Item(s) be recalled by XDx for any and/or repaired, ACBL or Seller will promptly communicate relevant facts to each other. ACBL shall determine whether a recall of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory Authority; or (C) where XDx determines that recall affected Items is necessary warranted or advisable for safety reasonsunless notice to that effect has been received from any governmental agency having jurisdiction. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required under the law or ACBL determines that it is advisable, Seller shall promptly undertake corrective actions, including those required by lawany applicable consumer protection or similar law and the regulations thereunder, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult file all necessary papers, descriptions or corrective action programs, and other related documents and carry out correction action programs. ACBL shall cooperate with XDx regarding the most appropriate course of and assist Seller in any such filings and corrective action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx nothing contained in this Section shall not reimburse preclude ACBL from taking such action, and in such event, Seller shall cooperate with and assist ACBL in any costs associated with the recall such filings and corrective action it elects to undertake. To the extent that such recall or rework is due determined to have been caused by a defect or quality or performance deficiency which is the faultresponsibility of Seller, negligenceat ACBL’s election, recklessness Seller shall perform all necessary repairs or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agentsmodifications at its sole expense, or their directorsACBL shall perform such necessary repairs or modifications and Seller shall reimburse ACBL for all costs and expenses incurred by ACBL in connection therewith. In either case, officersSeller shall reimburse ACBL for all costs and expenses incurred by ACBL in connection with any such (voluntary or required) recall, employees repair, replacement or agents refund program, including without limitation, the cost of locating, identifying Items, the cost of repairing, or due to a breach of this Agreement by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records where repair of the Distribution Item is impracticable or impossible, repurchasing or replacing the recalled Items, and cost of packing and shipping the Productrecalled Items, including methods for tracking and traceability as required under Applicable Laws and Regulationsthe cost of media notifications, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall if such form of any Product notification is requiredneeded.

Product Recall. 15.1 Product may be recalled by XDx for any of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by If any Regulatory Authority; or (C) where XDx determines that Authority in the Territory orders or requires the recall of any Product in the Territory, or if in GSK's opinion a recall is necessary in the Territory, GSK will promptly notify ALLERGAN and provide such information regarding such recall order or advisable other information as may be reasonably requested by ALLERGAN. GSK will, unless prohibited by Applicable Law, consult ALLERGAN on the need for safety reasonsa recall and take all ALLERGAN submissions into account when making a decision of whether to instigate or recall (such decision not to be unreasonably made). Diaxonhit shall administer GSK will be responsible for conducting any recall in the Territory and ALLERGAN will co-operate with GSK by providing all aspects such information and assistance as may be reasonably required to implement such recall. To the extent that any recall of any the Product recall is implemented as a result of Manufacturer's failure to Manufacture (as defined in the Supply Agreement) Product in accordance with provisions the terms and conditions of this clause 15. 15.2 the Supply Agreement, ALLERGAN will (a) bear all direct expenses incurred by GSK in connection with such recall, (b) indemnify the GSK Indemnitees (as defined in Section 8.1) from any and all Liabilities (as defined in Section 8.1) incurred by the GSK Indemnitees to the extent that these are proven to be attributable to the Manufacturer's failure to Manufacture Product in accordance with the terms and conditions of the Supply Agreement, and (c) either, at GSK's sole option, replace or credit GSK for the cost of the relevant Lots (as defined in the Supply Agreement) of Product subject to the recall. If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required due to any negligence or willful misconduct of a GSK Indemnitee, GSK will bear all such costs and expenses incurred ix xxxxxxxxxx xxxx xuch recall and will indemnify the ALLERGAN Indemnitees (as defined in Section 8.2) from and against any and all Liabilities incurred by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours the ALLERGAN Indemnitees that are proven to be attributable solely to the negligence or willful misconduct of such determination and shall consult with XDx regarding GSK. If any Regulatory Authority outside the most appropriate course of action. XDx shall review Territory orders or requires the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall the Products outside the Territory then ALLERGAN will promptly notify Diaxonhit in writing within twenty four (24) hours of GSK and provide such determination and the reason for information regarding such recall order or other information as may be reasonably requested by GSK. Except as set forth in Article 8, each Party's sole and Diaxonhit exclusive remedies for recalled Product shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard be limited to the recall and shall not make any other statement regarding such recallremedies provided in this Section 5.7. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach of this Agreement by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records of the Distribution of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall of any Product is required.

Product Recall. 15.1 8.1. If at any time or from time to time, a Competent Authority requests TTY to conduct a Product may be recalled Recall of any Product in the Territory or if a voluntary Product Recall of any Product in the Territory is contemplated by XDx for any TTY, TTY shall immediately notify BDSI in writing, and TTY will conduct such Product Recall (with full support from BDSI, subject to the conditions of section 8.4) in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the following reasons:Product and the goodwill and reputation of the Parties. 8.2. TTY shall not carry out a voluntary Product Recall in the Territory with respect to any Product without the prior written approval of BDSI, such approval not to be unreasonably withheld (for the avoidance of doubt, any Product Recall that is reasonably deemed necessary in order to avoid serious personal injury shall not be considered as a voluntary Product Recall, provided that TTY shall provide BDSI the opportunity to advise and comment with respect to any such Product Recall prior to its execution); and the Parties shall reasonably cooperate, in the conduct of any Product Recall for such Product in the Territory. Product Recall cost shall be borne in accordance with Section 8.5. 8.3. Notwithstanding the foregoing, TTY may, without BDSI’s prior consent, immediately affect any Product Recall (A) where resulting from any death or life-threatening adverse event associated with any Product or (B) required to comply with any regulatory or legal requirements, guidelines, directives, orders, or injunctions with respect to any Product. In the event TTY does not undertake such a Product Recall in a reasonable period of time, BDSI shall be entitled to do so without TTY’s prior written consent. 8.4. TTY shall have the right to control and/or conduct any Product Recall in the Territory, subject to the terms of this Agreement. The Product Recall shall be the responsibility of TTY and their Affiliates and shall be carried out by TTY or its Affiliates in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the Licensed Product and the goodwill and reputation of the Parties and BDSI shall provide all necessary support to TTY to carry out the Product Recall. TTY shall maintain records of all sales and distribution of Product and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Laws Law, and Regulations;make such records available to BDSI or any designee thereof immediately upon request. 8.5. TTY shall bear any and all costs and expenses related to any Product Recall in the Territory (B) following an order including but not limited to recall any Product Recall undertaken by BDSI in accordance with Section 8.3), provided that, notwithstanding the foregoing, BDSI shall bear any Regulatory Authority; or (C) where XDx determines such costs and expenses to the extent such Product Recall is reasonably demonstrated to be attributable to BDSI’s negligence, intentional misconduct, or supply of Licensed Products that recall is necessary or advisable do not conform to the Product Specifications. For clarification, BDSI shall be responsible for safety reasons. Diaxonhit shall administer all aspects the costs and expenses of any Product recall Recall that is shown in accordance with provisions of this clause 15section to have been attributable to BDSI’s negligence, intentional misconduct or in supplying Licensed Products that are not in conformance with the Product Specifications. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding 8.6. Throughout the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach duration of this Agreement and with respect to all Product the Parties shall immediately notify each other of any information a Party receives regarding any threatened or pending action, inspection or communication by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records or from a concerned Competent Authority which may affect the safety or efficacy claims of the Distribution Licensed Product or the continued marketing of the Licensed Product. Upon receipt of such information during the duration of this Agreement, including methods for tracking TTY shall not take any action whatsoever without BDSI’s prior review and traceability as required under Applicable Laws and Regulationsapproval, to enable appropriate procedures to such approval shall not be implemented in the event that a voluntary or mandatory recall of any Product is requiredunreasonably withheld.

Product Recall. 15.1 Product may be recalled by XDx for any of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by If any Regulatory Authority; or (C) where XDx determines that Authority in the Territory orders or requires the recall of any Product in the Territory, or if in GSK's opinion a recall is necessary in the Territory, GSK will promptly notify ALLERGAN and provide such information regarding such recall order or advisable other information as may be reasonably requested by ALLERGAN. GSK will, unless prohibited by Applicable Law, consult ALLERGAN on the need for safety reasonsa recall and take all ALLERGAN submissions into account when making a decision of whether to instigate or recall (such decision not to be unreasonably made). Diaxonhit shall administer GSK will be responsible for conducting any recall in the Territory and ALLERGAN will co-operate with GSK by providing all aspects such information and assistance as may be reasonably required to implement such recall. To the extent that any recall of any the Product recall is implemented as a result of Manufacturer's failure to Manufacture (as defined in the Supply Agreement) Product in accordance with provisions the terms and conditions of this clause 15. 15.2 the Supply Agreement, ALLERGAN will (a) bear all direct expenses incurred by GSK in connection with such recall, (b) indemnify the GSK Indemnitees (as defined in Section 8.1) from any and all Liabilities (as defined in Section 8.1) incurred by the GSK Indemnitees to the extent that these are proven to be attributable to the Manufacturer's failure to Manufacture Product in accordance with the terms and conditions of the Supply Agreement, and (c) either, at GSK's sole option, replace or credit GSK for the cost of the relevant Lots (as defined in the Supply Agreement) of Product subject to the recall. If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required due to any negligence or willful misconduct of a GSK Indemnitee, GSK will bear all such costs and expenses incurred ix xxxxxxxxxx xxxx xuch recall and will indemnify the ALLERGAN Indemnitees (as defined in Section 8.2) from and against any and all Liabilities incurred by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours the ALLERGAN Indemnitees that are proven to be attributable solely to the negligence or willful misconduct of such determination and shall consult with XDx regarding GSK. If any Regulatory Authority outside the most appropriate course of action. XDx shall review Territory orders or requires the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall the Products outside the Territory then ALLERGAN will promptly notify Diaxonhit in writing within twenty four (24) hours of GSK and provide such determination and the reason for information regarding such recall order or other information as may be reasonably requested by GSK. Except as set forth in Article ERROR! REFERENCE SOURCE NOT FOUND., each Party's sole and Diaxonhit exclusive remedies for recalled Product shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard be limited to the recall and shall not make any other statement regarding such recallremedies provided in this Section 5.8. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach of this Agreement by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records of the Distribution of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall of any Product is required.

Product Recall. 15.1 Product may be recalled by XDx NxStage shall have the sole right and responsibility for electing to recall worldwide any Lot or partial Lot of the following reasons: (A) where required Codes distributed or caused to be distributed by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory Authority; or (C) where XDx determines that recall is necessary or advisable for safety reasonsNxStage. Diaxonhit NxStage shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and recall. NxStage shall consult with XDx regarding the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit MDS in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries good faith regarding any recall of the Productrecommendations made by MDS relating to whether NxStage may institute a recall. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occursSection 15.4 below, if any Product is recalled, XDx NxStage shall reimburse Diaxonhit for the direct initially bear all out-of-pocket costs and expenses of activities incurred such recall, including, without limitation, refunds to customers for recalled Lots, the cost of notifying customers, and costs associated with the shipment of recalled Codes from customers to NxStage or MDS. NxStage shall maintain complete and accurate records, for such periods as may be required by applicable law, of all the Lots sold by NxStage. 15.2 In the event of a recall of any Lot or partial Lot of the Codes distributed or caused to be distributed by NxStage, the parties will cooperate fully with each other in effecting such a recall, including without limitation promptly contacting any purchasers and communicating to such purchasers any information or instructions that NxStage elects to communicate to such purchasers. 15.3 In the event of a recall of any Lot or partial Lot of the Codes distributed or caused to be distributed by NxStage where MDS and NxStage cannot agree on the responsible party, MDS and NxStage will have an independent laboratory, previously consented to by NxStage and MDS, which consent shall not be unreasonably withheld, audit sufficient recalled Lot units to determine if such Lot is in compliance with the Specifications, including all QC Standards. If the recalled Lots meet the Specifications, including all QC Standards then in effect at the time of MDS' acceptance of the Delivery Order related to such Lot then, subject to Section 15.4 below, NxStage shall bear all costs and expenses of the recall, including the cost of the audit. If the recalled Lots do not meet the Specifications, including all QC Standards, subject to Section 15.4 below, MDS shall bear all costs and expenses of the recall including the cost of the audit. Notwithstanding the above, if sufficient Lot units are not available to comprise a statistically significant sample size, yet a statistically significant increase in reported field failures attributable to the Product over prior Lots is recorded, the parties agree to use the Quality Dispute Resolution process as outlined in Section 9.8 to determine responsibility for the recall. Notwithstanding the outcome of the Quality Dispute Resolution process, MDS and NxStage shall cooperate on proposed manufacturing, design, or testing to address the field failures. 15.4 In the event of a recall of any Lot of Codes or partial Lot of Codes, MDS or NxStage may, once the recall has been substantially completed, invoke the Quality Dispute Resolution process as defined in Section 9.8, which outcome shall determine whether NxStage's initiation of recall was necessary and reasonable. The Quality Dispute Resolution process may result in arbitration which may require that NxStage or MDS bear all costs, damages and expenses, including reasonable attorney's fees of such recall or may apportion such costs and expenses between the parties as the arbitrator deems just. Notwithstanding the above, the obligations of either party to the other shall be subject to the limitations set forth in the last sentence of 11.2. 15.5 NxStage shall bear all costs and expenses of a recall to the degree caused by the negligence of NxStage or its agents or customers, improper or incorrect Specifications, inadequate QC Standards, defective Componentry supplied by NxStage or its vendors, or by breach of NxStage's regulatory responsibility as set forth in Section 8.0. MDS shall bear all costs and expenses of a recall to the degree caused by the negligence of MDS or its agents or vendors, or by breach of MDS' regulatory responsibility as set forth in Section 8. 15.6 If, and to the extent MDS is required by operation of this Agreement to bear the costs of a recall, and as a result of such recall NxStage orders and purchases from another supplier, or manufactures for itself, replacement product codes for recalled Codes, such replacement code orders shall be credited on a unit basis toward the recallapplicable Main Set Commitment, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx NxStage shall not reimburse any costs associated supply MDS with copies of such orders and the recall invoices related thereto or appropriate documentation of its manufacturing costs. In addition, to the extent that the cost of such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agentsreplacement products purchased from an unaffiliated third party supplier, or their directorsmanufactured by NxStage, officers, employees or agents or due to a breach of this Agreement by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records exceeds the then applicable prices of the Distribution Codes that were replaced, MDS will credit NxStage for such excess cost, provided however, such credit shall not exceed [**] percent ([**]%) of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in then applicable MDS prices of the event that a voluntary or mandatory recall of any Product is requiredCodes which were replaced.

Product Recall. 15.1 8.1. If at any time or from time to time, a Competent Authority requests TTY to conduct a Product may be recalled Recall of any Product in the Territory or if a voluntary Product Recall of any Product in the Territory is contemplated by XDx for any TTY, TTY shall immediately notify BDSI in writing, and TTY will conduct such Product Recall (with full support from BDSI, subject to the conditions of section 8.4) in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the following reasons:Product and the goodwill and reputation of the Parties. 8.2. TTY shall not carry out a voluntary Product Recall in the Territory with respect to any Product without the prior written approval of BDSI, such approval not to be unreasonably withheld (for the avoidance of doubt, any Product Recall that is reasonably deemed necessary in order to avoid serious personal injury shall not be considered as a voluntary Product Recall, provided that TTY shall provide BDSI the opportunity to advise and comment with respect to any such Product Recall prior to its execution); and the Parties shall reasonably cooperate, in the conduct of any Product Recall for such Product in the Territory. Product Recall cost shall be borne in accordance with Section 8.5. 8.3. Notwithstanding the foregoing, TTY may, without BDSI’s prior consent, immediately affect any Product Recall (A) where resulting from any death or life-threatening adverse event associated with any Product or (B) required to comply with any regulatory or legal requirements, guidelines, directives, orders, or injunctions with respect to any Product. In the event TTY does not undertake such a Product Recall in a reasonable period of time, BDSI shall be entitled to do so without TTY’s prior written consent. 8.4. TTY shall have the right to control and/or conduct any Product Recall in the Territory, subject to the terms of this Agreement. The Product Recall shall be the responsibility of TTY and their Affiliates and shall be carried out by TTY or its Affiliates in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the Licensed Product and the goodwill and reputation of the Parties and BDSI shall provide all necessary support to TTY to carry out the Product Recall. TTY shall maintain records of all sales and distribution of Product and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Laws Law, and Regulations;make such records available to BDSI or any designee thereof immediately upon request. WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***” 8.5. TTY shall bear any and all costs and expenses related to any Product Recall in the Territory (B) following an order including but not limited to recall any Product Recall undertaken by BDSI in accordance with Section 8.3), provided that, notwithstanding the foregoing, BDSI shall bear any Regulatory Authority; or (C) where XDx determines such costs and expenses to the extent such Product Recall is reasonably demonstrated to be attributable to BDSI’s negligence, intentional misconduct, or supply of Licensed Products that recall is necessary or advisable do not conform to the Product Specifications. For clarification, BDSI shall be responsible for safety reasons. Diaxonhit shall administer all aspects the costs and expenses of any Product recall Recall that is shown in accordance with provisions of this clause 15section to have been attributable to BDSI’s negligence, intentional misconduct or in supplying Licensed Products that are not in conformance with the Product Specifications. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding 8.6. Throughout the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach duration of this Agreement and with respect to all Product the Parties shall immediately notify each other of any information a Party receives regarding any threatened or pending action, inspection or communication by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records or from a concerned Competent Authority which may affect the safety or efficacy claims of the Distribution Licensed Product or the continued marketing of the Licensed Product. Upon receipt of such information during the duration of this Agreement, including methods for tracking TTY shall not take any action whatsoever without BDSI’s prior review and traceability as required under Applicable Laws and Regulationsapproval, to enable appropriate procedures to such approval shall not be implemented in the event that a voluntary or mandatory recall of any Product is requiredunreasonably withheld.

Product Recall. 15.1 7.1 If at any time or from time to time, a Competent Authority requests Licensee to conduct a recall or market withdrawal of any Licensed Product may be recalled from or in the Territory (a “Product Recall”) or if a voluntary Product Recall of any Licensed Product in the Territory is contemplated by XDx for any Licensee, Licensee shall immediately notify Licensor in writing, and Licensee will conduct such Product Recall (with full support from Licensor, subject to the conditions of Section 7.4) in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the following reasons:Licensed Product and the goodwill and reputation of the Parties. 7.2 Licensee shall not carry out a voluntary Product Recall in the Territory with respect to any Licensed Product without the prior written approval of Licensor, such approval not to be unreasonably withheld (for the avoidance of doubt, any Product Recall that is reasonably deemed necessary in order to avoid serious personal injury shall not be considered as a voluntary Product Recall, provided that Licensee shall provide Licensor the opportunity to advise and comment with respect to any such Product Recall prior to its execution); and the Parties shall reasonably cooperate, in the conduct of any Product Recall for such Licensed Product in the Territory. Product Recall cost shall be borne in accordance with Section 7.5. 7.3 Notwithstanding the foregoing, Licensee may, without Licensor’s prior consent, immediately affect any Product Recall (A) where resulting from any death or life-threatening adverse event associated with any Licensed Product or (B) required to comply with any regulatory or legal requirements, guidelines, directives, orders, or injunctions with respect to any Licensed Product. In the event Licensee does not undertake such a Product Recall in a reasonable period of time, Licensor shall be entitled to do so without Licensee’s prior written consent. 7.4 Licensee shall have the right to control and/or conduct any Product Recall in the Territory, subject to the terms of this Agreement. The Product Recall shall be the responsibility of Licensee and their Affiliates and shall be carried out by Licensee or its Affiliates in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the Licensed Product and the goodwill and reputation of the Parties and Licensor shall provide all necessary support to Licensee to carry out the Product Recall. Licensee shall maintain records of all sales and distribution of Licensed Product and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Laws Law, and Regulations;make such records available to Licensor or any designee thereof immediately upon request. (B) following an order 7.5 Licensee shall bear any and all costs and expenses related to recall by any Regulatory Authority; or (C) where XDx determines that recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall Recall in the Territory (including but not limited to any Product Recall undertaken by Licensor in accordance with provisions of this clause 15Section 7.3). 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding 7.6 Throughout the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach duration of this Agreement and with respect to all Licensed Product the Parties shall immediately notify each other of any information a Party receives regarding any threatened or pending action, inspection or communication by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records or from a concerned Competent Authority which may affect the safety or efficacy claims of the Distribution Licensed Product or the continued marketing of the Licensed Product. Upon receipt of such information during the duration of this Agreement, including methods for tracking Licensee shall not take any action whatsoever without Licensor’s prior review and traceability as required under Applicable Laws and Regulationsapproval, to enable appropriate procedures to such approval shall not be implemented in the event that a voluntary or mandatory recall of any Product is requiredunreasonably withheld.

Product Recall. 15.1 Product may be recalled by XDx for any of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory Authority; or (C) where XDx determines that recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 18.1 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware either Party believes that a recall of any Portal Measurement Product manufactured under this Manufacturing Agreement is desirable or required by law, it shall promptly notify the other Party. The Parties shall then Diaxonhit discuss reasonably and in good faith whether such recall is appropriate or required and the manner in which any mutually agreed recall shall notify XDx be handled. This Section 18 shall not limit the obligations of either Party under law with respect to recall of Portal Measurement Products required by law or properly mandated by governmental authority. Voluntary recalls shall be conducted by mutual agreement (with such agreement not to be unreasonably withheld) provided that if mutual agreement is not reached, either Party may individually conduct the voluntary recall in writing within twenty-four (24) hours of such determination question in a manner consistent with its own regulatory guidelines and criteria. The "Recalling Party" shall consult with XDx regarding the most appropriate course of action. XDx shall review the written notice bear all costs and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice expenses of any life endangering situation or requirement for a voluntary recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall Portal Measurement Products and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of reimburse the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit "Other Party" for the direct reasonable, out-of-pocket costs of activities incurred by the Other Party as a result of the such recall, including the replacement cost of any Portal Measurement Products affected thereby, unless (e.g., travel, transportation, destruction and publicity costsi) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due unjustified and neither requested nor classified as a recall by a governmental agency or delegee or (ii) the cause or basis of such recall is attributable to a condition, fact or action that constitutes (A) a breach by the fault, negligence, recklessness or wrong-doing Other Party of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach of this Agreement by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records hereunder or (B) negligence or willful misconduct of the Distribution Other Party in which case the Other Party will be liable for the costs and expenses of such recall, and shall reimburse the ProductRecalling Party for the reasonable, out-of-pocket costs incurred by Recalling Party as a result of such recall, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall replacement cost of any Product is requiredaffected thereby. The Parties shall cooperate fully with each other in effecting any recall of the Products pursuant to this Section 18, including communications with any customers or to the public.

Product Recall. 15.1 Product may be recalled by XDx for any of Schering-Plough will review with Centocor the following reasons: (A) where required by Applicable Laws -------------- Schering-Plough product recall procedures and Regulations; (B) following an order Schering-Plough agrees to recall by any Regulatory Authority; or (C) where XDx determines that recall is necessary or advisable for safety reasonsmaintain and to implement the same, subject to the provisions herein. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall Schering-Plough and Centocor have the responsibility to notify XDx in writing each other within twenty-four (24) hours of a situation which could lead to a recall or withdrawal of the Product in the Territory. Within forty-eight (48) hours after such determination notice, the parties' representatives from business, medical, regulatory, quality assurance and legal functions, and any others deemed necessary (the "Recall Team"), will consult to determine if any Product shall be withdrawn or recalled from the market. If the Recall Team agrees to conduct a recall, then the Recall Team shall also consult with XDx regarding respect to the most appropriate course timing of actionthe recall, the breadth, extent and level of customer to which the recall shall reach, and what strategies and notifications should be used. XDx shall review the written notice and provide a written response If agreement as to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for whether a recall should be conducted cannot be reached between the Schering-Plough and Centocor representatives on the Recall Team, the Oversight Committee shall be immediately consulted. If the Oversight Committee cannot agree, then the party holding the marketing authorizations for the Product in the Territory shall have final decision making authority with respect to any recall in the Territory and Centocor shall have final decision making authority with respect to countries outside the Territory. The license holder for the Product will be responsible for formal notification of the regulatory authorities; however, Centocor and Schering-Plough will coordinate with each other on the notification of regulatory authorities. In the Territory, Schering-Plough will be responsible to implement any Product mandated by any Regulatory Authority promptlywithdrawal or recall from the market. 15.3 If XDx determines (a) In the event that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx or withdrawal occurs in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred Territory as a result of adverse event or other safety reasons for which neither Centocor nor Schering-Plough are at fault, the recallparties shall share equally all reasonable costs and expenses of such Product recall or withdrawal in the Territory, (e.g.including, travelwithout limitation, transportationthe expenses incurred for the investigation, notification, regulatory reporting, destruction and publicity costs) except those internal and/or return of the recalled Product, the cost of the manufactured Product recalled, Schering- Plough's costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall relating to the extent testing, packaging, shipping and supplying the Product recalled, expenses or obligations to third parties, and the cost of notifying users (hereinafter the "Recall Expenses"). For purposes of calculating Recall Expenses under this Section 5.6(a) and under Sections 5.6(b) and (c), Centocor shall issue a credit to Schering-Plough for the full cost paid by Schering-Plough to Centocor for the manufactured Product recalled, and that such recall is due cost of the manufactured Product recalled shall be included in Recall Expenses at Centocor's cost of goods. Centocor and Schering-Plough each acknowledge that the obligations of the other under this Section do not extend to the faultexpenses or obligations of either to third parties or to any claim by either for loss of anticipated profits, negligencegoodwill, recklessness reputation, business receipts or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agentscontracts, or their directorslosses or expenses resulting from third party claims or for any indirect or consequential losses suffered by either, officershowsoever caused, employees and each hereby waives any claim to such expenses or agents losses or due to which may arise as a result of any such obligations. (b) In the event that any Product recall occurs as a result of (i) a breach of this Agreement by DiaxonhitCentocor, or (ii) any wrongful act or omission whether negligent or otherwise of Centocor, Centocor will bear all reasonable Recall Expenses incurred by Schering-Plough. Recall Expenses under this Section 5.6(b) shall be calculated as set forth in Section 5.6(a). Schering-Plough acknowledges that Centocor's obligations under this Section do not extend to expenses or obligations of Schering-Plough to third parties or to any claim by Schering-Plough for loss of anticipated profits, goodwill, reputation, business receipts or contracts, or losses or expenses resulting from third party claims or for any indirect or consequential losses suffered by Schering-Plough, howsoever caused, and hereby waives any claim to such expenses or losses or which may arise as a result of any such obligations. 15.6 (c) In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records of the Distribution of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that any Product recall occurs as a voluntary result of (i) a breach of this Agreement by Schering-Plough, or mandatory recall (ii) any wrongful act or omission, whether negligent or otherwise of Schering-Plough, Schering-Plough will bear all reasonable Recall Expenses incurred by Centocor. Recall Expenses under this Section 5.6(c) shall be calculated as set forth in Section 5.6(a). Centocor acknowledges that Schering-Plough's obligations under this Section do not extend to expenses or obligations of Centocor to third parties or to any claim by Centocor for loss of anticipated profits, goodwill, reputation, business receipts or contracts, or losses or expenses resulting from third party claims or for any indirect or consequential losses suffered by Centocor, howsoever caused, and hereby waives any claim to such expenses or losses or which may arise as a result of any Product is requiredsuch obligations.

Product Recall. 15.1 Product may be recalled by XDx for If any Relevant Regulatory Authority recommends, requests or requires the recall of any of the following reasons: (A) where required Products due to an act, omission or breach by Applicable Laws and Regulations; (B) following an order HAMELN with respect to recall by any Regulatory Authority; or (C) where XDx determines that recall is its obligations, covenants or warranties herein or HAMELN deems it necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that to initiate a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a voluntary recall of any Product mandated batch of Products due to an act, omission or breach by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because HAMELN with respect to its obligations, covenants or warranties herein, HAMELN will immediately notify LICENSEE of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed will consult with LICENSEE regarding the timely compliance with all applicable regulations and requirements pertaining to that recall. In the event of such a product recall, HAMELN will reimburse LICENSEE (i) within fifteen (15) days of such recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided all amounts paid by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement LICENSEE for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard Product subject to the recall; and (ii) within fifteen (15) days of LICENSEE’s invoice together with supporting documentation from the applicable wholesalers, all costs incurred by LICENSEE with respect to wholesaler recall costs; and shall not make any (iii) within fifteen (15) days of LICENSEE’s invoice, all other statement regarding such recall. 15.5 Subject costs incurred with respect to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result administration and implementation of the recall, including, but not limited to, (e.g.a) notification/approval of Relevant Regulatory Authorities; (b) notification to Product distributors/agents and customers and/or contractors; (c) market withdrawal or field correction; (d) return/destruction of recalled Products; and (e) reasonable legal costs. If any Relevant Regulatory Authority recommends, travelrequests or requires the recall of any of the Products due to an act, transportationomission or breach by LICENSEE with respect to its obligations, destruction covenants or warranties herein, LICENSEE will immediately notify HAMELN of such recall and publicity costswill consult with HAMELN regarding the timely compliance with all applicable regulations and requirements pertaining to that recall. In the event of such a product recall, LICENSEE will pay for all costs incurred with respect to the administration and implementation of such recall and LICENSEE will reimburse HAMELN within fifteen (15) except those internal days of HAMELN’s invoice, all costs directly incurred by HAMELN with respect to the administration and necessary to administer implementation of the recall, including, but not limited to, (a) notification/approval of Relevant Regulatory Authorities; provided, however, that XDx shall not reimburse any costs associated with the recall (b) notification to Product distributors/agents and customers and/or contractors; (c) market withdrawal or field correction; (d) return/destruction of recalled Products; and (e) reasonable legal costs. To the extent that such a product recall is not clearly due to the faultan act, negligence, recklessness omission or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach of this Agreement by Diaxonhit. 15.6 In addition either Party with respect to its obligations under clause 2.7obligations, Diaxonhit covenants or warranties herein, then the Parties shall keep complete mutually discuss and accurate records negotiate in good faith an equitable solution with respect to costs related to the administration and implementation of the Distribution of recall. Both Parties shall cooperate and use best efforts to minimize the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall costs of any Product is requiredproduct recall.

Product Recall. 15.1 7.10.1. If either Party becomes aware of information about distributed Product indicating that it may be recalled by XDx for any non-conforming with respect to the Specifications, Applicable Law, GMP, or the terms of the following reasons:Quality Agreement, or that there is potential adulteration, misbranding and/or any potential issues regarding safety or effectiveness with respect to the Product, it shall promptly serve written notice to that effect on the other Party. If such issue relates to a Defective Product, the LICENSOR shall initiate an investigation and assessment of such circumstances and shall provide IMMEDICA a written report of its findings and any proposed course of action to remedy such issue. 7.10.2. In the event: (Ai) where required by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory AuthorityAuthority or other national government authority issues a request, directive or order that Product be recalled; or (Cii) where XDx a court of competent jurisdiction orders such a recall; or (iii) IMMEDICA reasonably determines that recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by lawthe Parties shall take all appropriate corrective actions, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding cooperate in any governmental investigations surrounding the most appropriate course of actionrecall. XDx In the event the LICENSOR reasonably determines that Product should be recalled, the LICENSOR shall review the written provide notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of IMMEDICA including all relevant information that supports such determination. Diaxonhit shall give XDx notice Upon receipt of any life endangering situation or requirement such notice, IMMEDICA shall promptly initiate a Product recall. IMMEDICA will have the responsibility for a recall of any Product mandated by any all communications with Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit Authorities in writing within twenty four (24) hours of such determination the Territory and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries customers regarding any recall of Product in the ProductField. Diaxonhit shall use such prepared statement The LICENSOR will give IMMEDICA any assistance that IMMEDICA may reasonably request to respond to handle any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to 7.10.3. In the event that such recall results from a cap Defective Product that was a Defective Product at the time of 100% delivery of the Royalties actually received by XDx in Product, including the Sales Year in which breach of the LICENSOR’ s express warranties under Section 7.11, or the LICENSOR’s negligence, recklessness or willful misconduct (a recall occurs“LICENSOR Caused Recall”), if the LICENSOR shall at IMMEDICA’s option, promptly replace the quantity of Products that were recalled at no cost to IMMEDICA, or reimburse IMMEDICA for any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs incurred by IMMEDICA associated with the Products that were recalled (including all labeling and packaging costs, handling costs and transportation costs). In the event that IMMEDICA elects to have the recalled Product replaced, the LICENSOR shall replace such Product as soon as possible. In the event that IMMEDICA elects to be reimbursed for out-of-pocket costs associated with the recalled Products, the LICENSOR shall reimburse IMMEDICA within [*] of activities incurred as a result receipt of request from IMMEDICA for reimbursement. In addition, the LICENSOR agrees that it shall be responsible for the expenses of any such LICENSOR Caused recall. For purposes of this Agreement, the expenses of the recallrecall shall include the expenses of notification, (e.g.and destruction or return of the recalled Product, travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the distribution of the replacement Product. In the event that the recall was not a LICENSOR Caused Recall, then to the extent that such recall is due to affects Products in the faultTerritory in the Field, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach of this Agreement by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit the LICENSOR shall keep complete and accurate records not be responsible for the expenses of the Distribution of recall or for replacing or reimbursing the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall of any Product is requiredrelevant Products.

Product Recall. 15.1 7.10.1. If either Party becomes aware of information about distributed Product indicating that it may be recalled by XDx for any non-conforming with respect to the Specifications, Applicable Law, GMP, or the terms of the following reasons:Quality Agreement, or that there is potential adulteration, misbranding and/or any potential issues regarding safety or effectiveness with respect to the Product, it shall promptly serve written notice to that effect on the other Party. If such issue relates to a Defective Product that was a Defective Product at the time of delivery of the Product, the LICENSOR shall initiate an investigation and assessment of such circumstances and shall provide IMMEDICA a written report of its findings and any proposed course of action to remedy such issue. 7.10.2. In the event: (Ai) where required by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory AuthorityAuthority or other national government authority issues a request, directive or order that Product be recalled; or (Cii) where XDx a court of competent jurisdiction orders such a recall; or (iii) IMMEDICA reasonably determines that recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by lawthe Parties shall take all appropriate corrective actions, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding cooperate in any governmental investigations surrounding the most appropriate course of actionrecall. XDx In the event the LICENSOR reasonably determines that Product should be recalled, the LICENSOR shall review the written provide notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of IMMEDICA including all relevant information that supports such determination. Diaxonhit shall give XDx notice Upon receipt of any life endangering situation or requirement such notice, IMMEDICA shall promptly initiate a Product recall. IMMEDICA will have the responsibility for a recall of any Product mandated by any all communications with Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit Authorities in writing within twenty four (24) hours of such determination the Territory and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries customers regarding any recall of Product in the ProductField. Diaxonhit shall use such prepared statement The LICENSOR will give IMMEDICA any assistance that IMMEDICA may reasonably request to respond to handle any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to 7.10.3. In the event that such recall results from a cap Defective Product that was a Defective Product at the time of 100% delivery of the Royalties actually received by XDx in Product, including the Sales Year in which breach of the LICENSOR’s express warranties under Section 7.12, or the LICENSOR’s negligence, recklessness or willful misconduct (a recall occurs“LICENSOR Caused Recall”), if any the LICENSOR shall, at IMMEDICA’s option, promptly replace the quantity of Products that were recalled at no cost to IMMEDICA, or reimburse IMMEDICA for the cost of the Products that were recalled (including all labeling and packaging costs, administrative and handling costs and transportation costs). In the event that IMMEDICA elects to have the recalled Product is recalledreplaced, XDx the LICENSOR shall use Commercially Reasonable Efforts to replace such Product as soon as possible. In the event that IMMEDICA elects to be reimbursed for the cost of the recalled Products, the LICENSOR shall reimburse Diaxonhit IMMEDICA within [*] of receipt of request from IMMEDICA for reimbursement. In addition, the LICENSOR agrees that it shall be responsible for the direct out-of-pocket costs expenses of activities incurred as a result any recall. For purposes of this Agreement, the expenses of the recallrecall shall include the expenses of notification, (e.g.and destruction or return of the recalled Product, travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the distribution of the replacement Product. In the event that the recall was not a LICENSOR Caused Recall, then to the extent that such recall is due to affects Products in the faultTerritory in the Field, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach of this Agreement by Diaxonhit. 15.6 In addition to its obligations under clause 2.7, Diaxonhit the LICENSOR shall keep complete and accurate records not be responsible for the expenses of the Distribution recall or for replacing or reimbursing the relevant Products. 7.11. Payment of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall of any Product is required.Supply

Product Recall. 15.1 Product may be recalled by XDx for any (a) In the event of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory Authority; or (C) where XDx determines that recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15. 15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated in the Territory (which shall be done by ACADIA at its sole discretion but in compliance with all applicable laws, rules and regulations), ACADIA must pay all costs in association with such recall in the Territory, including reimbursement for the cost of any Regulatory Authority promptlyfaulty Product supplied by ACADIA or any Sub-Licensee, subject to Neuren’s indemnification obligation under clause 21.3. 15.3 If XDx determines that (b) In any case where a change in the risk-benefit-ratio of any Product should becomes evident or safety actions due to adverse drug reactions seem to be recalled because necessary (for example, change of safety reasonslabel, XDx product information, special information/warnings to the medical profession, patients or authorities or a Product recall), ACADIA will inform Neuren of material details in a timely fashion. 22 Publicity (a) The parties agree to jointly develop the first public announcement of the parties’ Development and Commercialization of the Product in the Territory on the Commencement Date. (b) ACADIA may issue subsequent public announcements with respect to its Development and Commercialization of Product in the Territory for any purpose. (c) In subsequent public announcements, Neuren shall notify Diaxonhit not include information regarding the development and commercialization of Product in writing within twenty four the Territory that is not already in the public domain without the prior written approval of ACADIA, not to be unreasonably withheld. (24d) hours The parties agree to consult with each other reasonably and in good faith with respect to the text and timing of public announcements or press releases regarding activities with respect to any Product contemplated by this Agreement prior to the issuance of any such determination and announcement or press releases to the reason for such recall and Diaxonhit shall proceed with the recall extent not previously disclosed in accordance with Diaxonhit’s recall procedures this clause 22, provided that a party may not unreasonably withhold, condition or delay consent to such announcements or releases, and any reasonable instructions provided by XDxthat either party may issue such press releases or make such disclosures to the SEC pursuant to Form 8-K or pursuant to local fiscal reporting laws, filing regulations and stock exchange disclosure rules or otherwise as it determines, based on advice of counsel, are reasonably necessary to comply with applicable laws, rules or regulations or for appropriate market disclosure. 15.4 Following (e) The parties will consult with each other on the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall. 15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach provisions of this Agreement to be redacted in any filings made by Diaxonhit. 15.6 a party with the SEC or as otherwise required by applicable laws, rules or regulations. In addition addition, following the initial joint press release announcing this Agreement, either party shall be free to its obligations under clause 2.7disclose, Diaxonhit shall keep complete and accurate records without the other party’s prior written consent, the existence of this Agreement, the identity of the Distribution other party and those terms of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented Agreement which have already been publicly disclosed in the event that a voluntary or mandatory recall of any Product is required.accordance herewith. Licence Agreement ½ Page 43

Product Recall. 15.1 Product a. Licensee shall establish, in writing, a product recall program for the Licensed Products, a summary of which shall be subject to the prior written approval of Licensor. Licensee shall modify such program to conform to any reasonable requests made by Licensor. Licensee shall report to Licensor all alterations to such program and shall revise such alterations to such program to comply with any reasonable request for such revision as Licensor may be recalled by XDx for any of the following reasons: (A) where required by Applicable Laws and Regulations; (B) following an order to recall by any Regulatory Authority; or (C) where XDx determines make. Such program shall provide that recall is necessary or advisable for safety reasons. Diaxonhit Licensee shall administer all aspects immediately advise Licensor of any Product recall considerations or deliberations and provide Licensor with the right to attend and participate in accordance with provisions of this clause 15such deliberations. 15.2 If Diaxonhit determines that any Product should be recalledb. Licensee shall have complete responsibility for recalls related to the Licensed Products. Notwithstanding the foregoing, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit Licensor shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding have the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly. 15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx. 15.4 Following the decision absolute right to recall any Product, XDx shall provide Diaxonhit with a prepared statement for if it determines that the use in response to any inquiries regarding any recall and/or distribution of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard same may, in its sole opinion, pose a risk to the health and welfare of the public in a manner consistent with established United States Food and Drug Administration policy or damage or endanger the good will of the Licensed Trademarks. Notwithstanding Licensor’s right to recall any Product as set forth in the preceding sentence, Licensor agrees to coordinate its activities with respect to such recall with Licensee as long as Licensee has commenced and is diligently prosecuting to completion a recall as required herein. Upon notice of any such recall, including oral notice, Licensee shall immediately recover all materials required by Licensor to be recovered and shall not make any other statement regarding dispose of such recallmaterials as directed by Licensor or applicable regulatory authority. 15.5 Subject to a cap of 100% c. In recognition of the Royalties actually received by XDx in paramount importance of protecting the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result health and welfare of the recall, (e.g., travel, transportation, destruction public and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs good will associated with the recall Licensed Trademarks, Licensor and Licensee agree to take whatever steps are necessary to xxxxx any health risk or possible damage to the extent that such good will of the Licensed Trademarks as quickly and effectively as possible. Licensee shall contact Licensor’s Quality & Regulatory Compliance department immediately if consideration is being given to involve a Licensed Product in a recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agentsmarket withdraw, or their directors, officers, employees if a consumer alleges illness or agents injury or due threatens to a breach of this Agreement by Diaxonhitcontact any government agency or media. Licensee shall provide Licensor with the right to have input into recall or market withdraw considerations and into responses to government agency or media communications. 15.6 In addition to its obligations under clause 2.7, Diaxonhit shall keep complete and accurate records of the Distribution of the Product, including methods for tracking and traceability as required under Applicable Laws and Regulations, to enable appropriate procedures to be implemented in the event that a voluntary or mandatory recall of any Product is required.