Common use of Recalls Clause in Contracts

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In the event that PEKO becomes aware of any part fabricated by it or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. (c) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO pursuant to Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO QED with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO QED pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO QED of its duties under the Agreement or (ii) PEKOQED’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretomisconduct. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In ViewRay and QED will coordinate any statements to customers and the event that PEKO becomes aware of any part fabricated by it media, including, but not limited to, press releases and interviews for publication or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. (c) Each broadcast and neither party will promptly (within two (2) working days unless a shorter time period is required under applicable law) notify issue any such statements without consulting with the other and neither party shall identify the other party in writing any such statements without the other party’s written consent, not to be unreasonably withheld, except as required by a Regulatory Authority. The parties will reasonably cooperate with each other in the conduct of such activities and will perform any event acts reasonably requested by the other party to facilitate the recall, withdrawal or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’sfield correction. Each party will keep the other party fully informed of progress and in relation to all material decisions or actions such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO party undertakes pursuant to this Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions4.4(b).

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO Tesla with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the applicable Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO Tesla pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO Tesla of its duties under the Agreement or (ii) PEKOTesla’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretomisconduct. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay systemProduct, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In ViewRay and Tesla will coordinate any statements to customers and the event that PEKO becomes aware of any part fabricated by it media, including, but not limited to, press releases and interviews for publication or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. (c) Each broadcast and neither party will promptly (within two (2) working days unless a shorter time period is required under applicable law) notify issue any such statements without consulting with the other and neither party shall identify the other party in writing any such statements without the other party’s written consent, not to be unreasonably withheld, except as required by a Regulatory Authority. The parties will reasonably cooperate with each other in the conduct of such activities and will perform any event acts reasonably requested by the other party to facilitate the recall, withdrawal or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’sfield correction. Each party will keep the other party fully informed of progress and in relation to all material decisions or actions such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO party undertakes pursuant to this Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto4.3(b). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO Jastec with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO Jastec pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO Jastec of its duties under the Agreement or (ii) PEKOJastec’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretomisconduct. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In ViewRay and Jastec will coordinate any statements to customers and the event that PEKO becomes aware media, including, but not limited to, press releases and interviews for publication or broadcast and neither party will issue any such statements without consulting with the other and neither party shall identify the other party in any such statements without the other party’s written consent, not to be unreasonably withheld, except as required by a Regulatory Authority. The parties will reasonably cooperate with each other in the conduct of such activities and will perform any part fabricated acts reasonably requested by it the other party to facilitate the recall, withdrawal or any assembly is not field correction. Each party will keep the other party fully informed of progress and in conformance relation to ViewRay specifications PEKO shall promptly notify ViewRayall material decisions or actions such party undertakes pursuant to this Section 4.4(b). (c) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable lawApplicable Law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. C.P.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO Jastec pursuant to Section 7.3 only 8.3 if such AER is solely the direct result of (i) any breach by PEKO Jastec of its duties under the Agreement or (ii) PEKOJastec’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretomisconduct. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Recalls. (a) Prior Product recalls will be the responsibility of, and under the control of, Client. In the event that Hovione has reason to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about believe that any Product indicating that it may not conform to the Specificationsshould be recalled or withdrawn from distribution, it will promptly so inform Client in writing of such belief. Client will notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses Regulatory Authorities of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. (b) With respect to any recall, withdrawalif required under Applicable Law, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee and will be responsible for coordinating all of the necessary activities in connection with such regarding the action taken. Hovione and Client will fully cooperate to complete the recall, withdrawal, or field correction. In the event that PEKO becomes aware and will thereafter resolve any allocation of any part fabricated by it or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. (c) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, liability as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof may be appropriate in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under terms of this Agreement. If, The costs and expenses of conducting any recall will be treated as follows: (a) If any Product is recalled as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO pursuant to Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKOHovione’s negligence or willful misconduct without any action in Manufacture of the Product or activity or negligence of ViewRay contributing thereto. [***] Certain information failure to Manufacture Product in this document has been omitted and filed separately accordance with the Securities and Exchange Commission. Confidential treatment has been requested with respect Manufacturing Standards then, except to the omitted portionsextent the recall resulted from any failure of Client-Supplied Materials unless Hovione knew of, or should have known of a failure of the Client Supplied Materials to conform to the applicable Material Specifications, as a result the testing of Client-Supplied Materials the parties had mutually agreed in writing would be performed by Hovione as part of Services, *. In addition, in such event, Hovione, *, will promptly replace such rejected and recalled amounts with Product that conforms to the Product Specifications and is Manufactured in accordance with the Manufacturing Standards and shall reimburse Client for Material Loss in accordance with Section 6.6. Hovione’s total liability to Client under this Section 8.11 for each particular recall, market withdrawal or correction shall not exceed the aggregate Manufacturing Fees, if any, paid by Client to Hovione for the total amount of Product that is contained in the drug product that is recalled, withdrawn from the market or corrected. In addition, the limitations set forth in Section 14.4 hereof shall also apply to any liability of Hovione under this Section 8.11. (b) If each Party contributes to the cause for a recall, the amounts contemplated under paragraph (a) will be *; and (c) All recalls of Product supplied to Client under this Agreement other than those described in clauses (a) or (b) will be at * sole expense. Client will give Hovione prompt written notice of any Product recalls for which Client believes Hovione has responsibility under Section 8.11(a) or (b).

Recalls. (a) Prior to 3.1 In the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any event that Faulding or Purepac determines that a Product indicating that it may does not conform to the SpecificationsSpecifications or that it should be recalled for any other reason, prior to taking any action, it will shall give written notice to the other party and the Distributor specifying its reasons for the necessity of a recall (the "Recall Notice") or if either party receives a Recall Notice from the Distributor, it shall promptly so notify the other party. If either Faulding or Purepac has requested the recall or Faulding agrees with the determination made by the Distributor as stated in a Recall Notice given by the Distributor to Faulding, and relayed by Faulding to Purepac, or the FDA has requested a recall or voluntary market withdrawal, the parties agree that the Distributor shall handle the administration of the recall and that Purepac shall use its best efforts, consistent with relevant requirements and restrictions of the FDA, to replace all Product recalled within one hundred twenty (120) days from the date of the Recall Notice. The Distributor shall be reimbursed for all out-of-pocket expenses relating to such recall (a) by Purepac if it is determined, as set forth in Section 2.2, that the recalled Product does not meet Specifications or is otherwise defective as a result of a Defect Caused by Purepac and (b) by Faulding if the recall has been agreed to by the parties for any other reason. However, if the Distributor, in its sole determination, with a Recall Notice to Faulding, initiates and implements a Product recall, Purepac will not be required to replace the recalled Product and reimburse the Distributor for expenses as provided in the preceding sentence or Section 3.2, without a determination, as set forth in Section 2.2 that the Product recalled did not meet Specifications or is otherwise defective. 3.2 The parties agree to abide by any recall/voluntary market withdrawal request of the FDA. Moreover, the parties agree that in all cases, the Distributor will promptly confer handle the administration of the recalls as follows: (a) If within ten (10) days from the date of a Recall Notice from the Distributor, Faulding has been unable to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent reach an agreement with the SOPs. ViewRay will have Distributor concerning the right to initiate, and will bear all costs associated with, necessity of a recall, withdrawalthe parties hereto agree that the Product shall be submitted to a mutually acceptable independent laboratory for a Report, or field correction the cost of which shall be borne by Purepac only if the finding of the ViewRay system incorporating Report is that the Product for any reason; provided that ViewRay does not meet Specifications or is otherwise defective as a result of a Defect Caused by Purepac and otherwise, as the case may proceed against PEKO pursuant to Section 7.3 only if such recallbe, withdrawal, by Faulding or field correction the Distributor as set forth under the terms of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretoDistribution Agreement. (b) With respect to any recall, withdrawal, In the event that the finding of the Report is that the Product does not meet Specifications or field correction is otherwise defective as a result of a Product incorporated in a ViewRay systemDefect Caused by Purepac, ViewRay or its designee will be responsible for coordinating all Purepac shall, consistent with relevant requirements and restrictions of the necessary activities in connection with FDA and at its own cost, use its best efforts to replace all Product recalled within one hundred twenty (120) days from the date of the Report and shall reimburse the Distributor for all reasonable out-of-pocket expenses relating to such recall, withdrawal, or field correction. In the event that PEKO becomes aware of the discrepancy is resolved in the Report against Faulding\Purepac for any part fabricated by it reason other than that the Product does not meet Specifications or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. (c) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, defective as a result of any corrective action or any finala Defect Caused by Purepac, non-appealable or non-appealed governmental or court actionthe parties agree that the Distributor shall handle the administration of the recall (unless the Distributor has by that time already implemented the recall in question pursuant to the last sentence of Section 3.1} and Purepac, an AER is required at Faulding's cost, shall use its best efforts , consistent with relevant requirements and restrictions of the FDA, to be issued for any replace all Product sold hereunder, ViewRay will bear recalled within one hundred twenty (120) days from the costs date of the Report and expenses of and will be responsible Faulding shall reimburse the Distributor for all corrective actions associated with reasonable out-of-pocket expenses relating to such AER but may proceed against PEKO recall. In the event that the discrepancy is resolved in the Report in favor of Faulding\Purepac and the Distributor elects to recall the Product notwithstanding the Report, the parties agree that the Distributor shall handle the administration of the recall (unless the Distributor has by that time already implemented the recall in question pursuant to the last sentence of Section 7.3 only if 3.1). In such AER is solely event, neither of the direct result of (i) parties to this Agreement will have any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested obligation with respect to replacement of the omitted portionsProduct or reimbursement of the Distributor's expenses. 3.3 Faulding and Purepac shall each advise the other party, by written notice, in the event that it learns of any facts or circumstances which could warrant the recall of the Product for reasons of safety, health or efficacy.

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO Jastec with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO Jastec pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO Jastec of its duties under the Agreement or (ii) PEKOJastec’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretomisconduct. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In ViewRay and Jastec will coordinate any statements to customers and the event that PEKO becomes aware media, including, but not limited to, press releases and interviews for publication or broadcast and neither party will issue any such statements without consulting with the other and neither party shall identify the other party in any such statements without the other party’s written consent, not to be unreasonably withheld, except as required by a Regulatory Authority. The parties will reasonably cooperate with each other in the conduct of such activities and will perform any part fabricated acts reasonably requested by it the other party to facilitate the recall, withdrawal or any assembly is not field correction. Each party will keep the other party fully informed of progress and in conformance relation to ViewRay specifications PEKO shall promptly notify ViewRayall material decisions or actions such party undertakes pursuant to this Section 4.4(b). (c) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable lawApplicable Law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. C.P.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO Jastec pursuant to Section 7.3 only 8.3 if such AER is solely the direct result of (i) any breach by PEKO Jastec of its duties under the Agreement or (ii) PEKOJastec’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsmisconduct.

Recalls. (a) Prior Any decision to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, initiate a recall, withdrawal, recall or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. (b) With respect to any recall, withdrawal, or field correction withdrawal of a Product incorporated or MDX-1379 in a ViewRay systemthe United States shall be made by the applicable Lead Regulatory Party, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In the event that PEKO becomes aware of any part fabricated by it or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. (c) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance after consultation with the MDR regulationJEC, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. Ifprovided that if, as a result of patient safety concerns, there is not sufficient time for the JEC to meet, and in any corrective action event before the applicable Lead Regulatory Party initiates a recall or withdrawal, the Parties shall promptly and in good faith discuss the reasons therefor and the strategy for implementing any final, non-appealable such recall or non-appealed governmental withdrawal. The costs of any such recall or court action, withdrawal relating to (a) the Development of a Product or MDX-1379 for an AER is required Indication prior to be issued the Initial Regulatory Approval (or Compendia Listing) for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO pursuant to Section 7.3 only if such AER is solely the direct result of Indication (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested other than with respect to a recall related to a Partially Co-Funded Indication) or the omitted portionsCommercialization of a Co-Promotion Product, each shall be Regulatory Expenses, and (b) the Development of a Product or MDX-1379 for a Partially Co-Funded Indication or the Commercialization of a Non-Co-Promoted Product, each shall be borne solely by BMS and shall be excluded from Development Costs and Allowable Expenses, except, in each case ((a) and (b)), to the extent that any such recall or withdrawal is attributable to (x) the negligence of a Party, in which event such Party shall bear such costs or (y) the negligence of both Parties, in which event each Party shall bear such costs to the extent of its respective responsibility; and in either case ((x) or (y)), such costs shall be excluded from Development Costs and Allowable Expenses. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and with respect to Co-Promotion Products, neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Product to meet the Specifications, for material safety concerns, for the manufacture of such Product in a manner that does not comply with the Act or as requested by Regulatory Authorities. In the event of any recall or withdrawal, the Lead Regulatory Party shall take any and all necessary action to implement such recall or withdrawal in accordance with Applicable Law, with assistance from the other Party as reasonably requested.

Recalls. To the extent (a) Prior to the commercial release of the ViewRay system incorporating the Productany governmental or regulatory authority issues a request, ViewRay will provide PEKO with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating directive or order that it may not conform to the Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant to Section 7.3 only if such recallbe recalled or withdrawn in the Territory, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. (b) With respect to any recall, withdrawal, a court of competent jurisdiction orders a recall or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will be responsible for coordinating all withdrawal of the Product in the Territory or (c) either Party determines, after consultation with the other Party, that the Product should be recalled or withdrawn in the Territory, the Parties shall recall or withdraw the Product as set forth in this Section 8.2. As between the Parties, Astellas shall control and coordinate, including making all contacts with regulatory authorities, all activities it deems necessary activities in connection with such recallrecall or withdrawal in the Territory. All out-of-pocket expenses related to the execution of any recall or withdrawal of the Product (“Recall Costs”) shall be shared equally between the Parties, provided that in the case of (c) above, if the Parties do not mutually agree on having the Product recalled or withdrawn, then the Party requesting the recall or withdrawal shall bear initially the entire expense of such recall or withdrawal, or field correction; but in each case subject to the final allocation between the Parties as follows. In the event that PEKO becomes aware of any part fabricated by it is finally determined, or any assembly agreed between the Parties, that such recall or withdrawal is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. caused by: (ca) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning breach of the Federal Foodrepresentations and warranties of XenoPort set forth in Section 13.2 below, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO pursuant to Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s gross negligence or willful misconduct without any action of XenoPort, or activity the failure by XenoPort to comply with applicable laws and regulations (collectively, the “Fault of XenoPort”) XenoPort shall be responsible for Recall Costs to extent of such Fault of XenoPort, (b) the failure of Astellas to properly perform the manufacturing, formulation or packaging of the Compound and/or Products, or the gross negligence or willful misconduct of ViewRay contributing thereto. [***] Certain information Astellas, or the failure by Astellas to comply with applicable laws and regulations, including its failure to properly file for Marketing Approval of the Products in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect Territory (collectively, the “Fault of Astellas”), Astellas shall be responsible for Recall Costs to the omitted portionsextent of such Fault of Astellas and (c) in all other cases, the Recall Costs shall be shared by the Parties as follows: [… * …] shall be borne by Astellas and [… * …] shall be borne by XenoPort.

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO Tesla with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the applicable Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, ,[***] a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant [***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretoomitted portions. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay systemProduct, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In ViewRay and Tesla will coordinate any statements to customers and the event that PEKO becomes aware media, including, but not limited to, press releases and interviews for publication or broadcast and neither party will issue any such statements without consulting with the other and neither party shall identify the other party in any such statements without the other party’s written consent, not to be unreasonably withheld, except as required by a Regulatory Authority. The parties will reasonably cooperate with each other in the conduct of such activities and will perform any part fabricated acts reasonably requested by it the other party to facilitate the recall, withdrawal or any assembly is not field correction. Each party will keep the other party fully informed of progress and in conformance relation to ViewRay specifications PEKO shall promptly notify ViewRayall material decisions or actions such party undertakes pursuant to this Section 4.3(b). (c) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable law[***]) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO pursuant to Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions].

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the Specifications, it will Each Party shall promptly so notify the other party. The parties will promptly confer Party in writing if it determines that any event, incident or circumstance has occurred which may result in the need for a “recall” or “market withdrawal” (as such terms are defined in 21 CFR 7.3 or other similar national, state or local law or regulation) (hereinafter referred to discuss such circumstances and to consider appropriate courses as a “Recall”) of action, which courses of action will be consistent with a Collaboration Product or any lot(s) thereof in the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretoTerritory. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will Pharmacia shall be responsible for coordinating determining whether and upon what terms and conditions Collaboration Product shall be Recalled or otherwise withdrawn from sale to Third Parties within any country in the Territory. Pharmacia shall be responsible for discussions with Regulatory Authorities within the applicable country regarding all aspects of the necessary activities Recall decision and the execution thereof. Upon the request of Pharmacia, Nastech shall reasonably cooperate in connection with such recall, withdrawal, or field correction. In the event that PEKO becomes aware of any part fabricated by it or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRayall Recall efforts. (c) Each party will promptly If at any time in respect of the Territory (within two i) any governmental or Regulatory Authority in the Territory issues a request, directive or order for a Recall of a Collaboration Product in the Territory; or (2ii) working days unless a shorter time period is required under applicable lawcourt of competent jurisdiction orders a Recall of a Collaboration Product in the Territory; then Pharmacia shall be responsible for implementing such Recall with the expenses arising from such Recall to be allocated as set forth in Section 7.4(d) notify below (d) All costs and expenses associated with implementing a Recall of a Collaboration Product in the other party in writing Territory shall be allocated between the Parties as follows: (i) In the event, and to the extent, that the Recall arises out of (x) the negligence or willful wrongdoing of Nastech or its Affiliates, (y) a material breach of this Agreement or the Supply Agreement by Nastech or its Affiliate(s), or (z) the inaccuracy of any event representation or complaint that gives rise warranty of Nastech or could give rise to the need to file a Medical Device Report (an “MDR”its Affiliate(s) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) hereunder or a similar report under the laws or regulations administered by any Regulatory Authority (collectivelySupply Agreement, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will Nastech shall bear the costs and expenses of and will be responsible for all corrective actions associated with the Recall (including any out-of-pocket expenses reasonably incurred by Pharmacia in conducting such AER but may proceed against PEKO pursuant Recall) up to Section 7.3 only if such AER is solely the direct result of one-hundred percent (i100%) any breach by PEKO of its duties under the Agreement or thereof. (ii) PEKO’s negligence or willful misconduct without In the event, and to the extent, that the Recall does not arise out of any action or activity or negligence of ViewRay contributing thereto. [***] Certain information the events set forth in this document has been omitted Section 7.4(d)(i), Pharmacia shall bear the costs and filed separately expenses associated with the Securities and Exchange Commission. Confidential treatment has been requested with respect Recall (including any out-of-pocket expenses reasonably incurred by Nastech in assisting Pharmacia in conducting such Recall) up to the omitted portionsone-hundred percent (100%) thereof.

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, [***] a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto[***]. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In the event that PEKO becomes aware of any part fabricated by it or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. (c) Each party will promptly (within two (2) working days [***] unless a shorter time period is required under applicable law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO pursuant to Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto[***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Recalls. (a) Prior to the commercial release of the ViewRay system incorporating the Product, ViewRay will provide PEKO Jastec with ViewRay’s standard operating procedures (“SOPs”) as to recalls. If either party becomes aware of information about any Product indicating that it may not conform to the Specifications, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs. ViewRay will have the right to initiate, and will bear all costs associated with, [***] a recall, withdrawal, or field correction of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto[***]. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In ViewRay and Jastec will coordinate any statements to customers and the event that PEKO becomes aware media, including, but not limited to, press releases and interviews for publication or broadcast and neither party will issue any such statements without consulting with the other and neither party shall identify the other party in any such statements without the other party’s written consent, not to be unreasonably withheld, except as required by a Regulatory Authority. The parties will reasonably cooperate with each other in the conduct of such activities and will perform any part fabricated acts reasonably requested by it the other party to facilitate the recall, withdrawal or any assembly is not field correction. Each party will keep the other party fully informed of progress and in conformance relation to ViewRay specifications PEKO shall promptly notify ViewRayall material decisions or actions such party undertakes pursuant to this Section 4.4(b). (c) Each party will promptly (within two (2) working days [***] unless a shorter time period is required under applicable lawApplicable Law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. C.P.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO pursuant to Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions].

Recalls. The Parties shall immediately inform each other in writing of all information related to (a) Prior any incident relating to a PRODUCT and/or any lot of a PRODUCT that is the commercial release subject of the ViewRay system incorporating the Productrecall, ViewRay will provide PEKO with ViewRay’s standard operating procedures market withdrawal or correction, or (“SOPs”b) as to recallsany PRODUCT that may require, whether based on manufacturing defect, tampering, or otherwise, a recall, field alert, product withdrawal or field correction arising from any defect in any such PRODUCT provided under this Agreement. If either party becomes aware Party believes that a recall of information about any Product indicating that it may not conform to the SpecificationsUNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY is desirable or required by law, it will promptly so notify the other partyParty. The parties Parties will promptly confer then discuss reasonably and in good faith whether such recall is appropriate or required and the manner in which any recall shall be handled; provided, however, in the event either Party determines that a recall is necessary, such recall shall be implemented. Coul▇▇▇ ▇▇▇ll be solely responsible for the handling and disposition of such recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in TERRITORY A, pursuant to discuss procedures set forth on EXHIBIT J. SB shall cooperate with Coul▇▇▇ ▇▇ allowing such circumstances recall in TERRITORY A to occur pursuant to the procedures set forth on EXHIBIT J. SB shall be solely responsible for the handling and disposition of such recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in the NON-USA TERRITORY, pursuant to consider appropriate courses of action, which courses of action will procedures set forth on EXHIBIT J. C▇▇▇▇▇▇ ▇▇▇ll cooperate with SB in allowing such recall in the NON-USA TERRITORY to occur pursuant to the procedures set forth on EXHIBIT J. EXHIBIT J may be consistent with modified at any time by the SOPs. ViewRay will have MANUFACTURE AND SUPPLY CHAIN SUBTEAM subject to the right to initiate, and will bear all costs associated with, a recall, withdrawal, or field correction approval of the ViewRay system incorporating the Product for any reason; provided that ViewRay may proceed against PEKO pursuant to Section 7.3 only if such recall, withdrawal, or field correction of the ViewRay system incorporating the Product is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing theretoJDC and JCC. (b) With respect to any recall, withdrawal, or field correction of a Product incorporated in a ViewRay system, ViewRay or its designee will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. In the event that PEKO becomes aware of any part fabricated by it or any assembly is not in conformance to ViewRay specifications PEKO shall promptly notify ViewRay. (c) Each party will promptly (within two (2) working days unless a shorter time period is required under applicable law) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act of 1941, as amended (the “Act”) or a similar report under the laws or regulations administered by any Regulatory Authority (collectively, an “AER”), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803 or similar regulations covering AER’s. Each such written notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, ViewRay will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but may proceed against PEKO pursuant to Section 7.3 only if such AER is solely the direct result of (i) any breach by PEKO of its duties under the Agreement or (ii) PEKO’s negligence or willful misconduct without any action or activity or negligence of ViewRay contributing thereto. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.