Product Liability Claims. Notwithstanding the foregoing Sections 12.02 and 12.03, the Parties’ responsibilities with respect to Product Liability Claims shall be governed by this Section12.04. (i) BTG shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect. (ii) Each Party shall give the other prompt written notice of any Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.04, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each Product Liability Claim, Savient shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim within ninety (90) days following Savient’s receipt of notice of the commencement or assertion of such Product Liability Claim, BTG may notify Savient of BTG’s desire to take the lead role in the defense of such Product Liability Claim. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) shall consult with the other Party on all material aspects of the defense, including without limitation settlement, of such Product Liability Claim, and the Parties shall cooperate fully with each other in connection therewith. The non-defending Party shall also have the right to participate in the defense of any Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and defense of each Product Liability Claim. The Controlling Party will otherwise keep the other Party fully informed of the status and progress of the defense and any settlement discussions concerning the Product Liability Claim. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, shall be subject to the prior written approval of both Parties, such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties in accordance with Section 12.04 (i).
Appears in 4 contracts
Samples: Commercial Supply Agreement (Horizon Therapeutics Public LTD Co), Commercial Supply Agreement (Horizon Pharma PLC), Commercial Supply Agreement (Horizon Pharma PLC)
Product Liability Claims. Notwithstanding the foregoing Sections 12.02 and 12.03, the Parties’ responsibilities If any Party becomes aware of a Product Liability Claim solely with respect to Licensed Product Liability Claims sold by PAR or its Affiliates during the Term that is not otherwise subject to indemnification by a Party under Section 12.1, 12.2 or 12.3, it shall be governed by this Section12.04.
(i) BTG shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect.
(ii) Each Party shall give promptly notify the other prompt written notice Parties in writing of any Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.04, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each Product Liability Claim, Savient shall have the first right to defend and settle such Product Liability Claim. PAR shall have the first option to control the defense of such Product Liability Claim with counsel of its choice and PAR will fund the litigation expenses with respect to such Product Liability Claim; provided that NovaDel shall reimburse PAR for [***]% of such expenses within forty-five (45) days of receiving an invoice setting forth such expenses and NovaDel’s share of the same. NovaDel will have the option of joining in any action related to such Product Liability Claim, and upon so joining, if NovaDel shall be represented in such action by its own counsel, such representation shall be at its own expense. In the event that Savient PAR does not assume the defense of so elect to defend against such Product Liability Claim within ninety (90) days following Savient’s receipt of notice becoming aware of the commencement or assertion same, NovaDel shall be free to proceed and solely control such defense and NovaDel shall fund the litigation expenses with respect to such Product Liability Claim; provided that PAR shall reimburse NovaDel for [***]% of such expenses within forty-five (45) days of receiving an invoice setting forth such expenses and PAR’s share of the same. Each Party, and its employees and agents, shall provide to the other Party and its legal representatives reasonable assistance and cooperation with respect to such Product Liability Claim, BTG including entering into any joint defense and/or joint privilege agreement that may notify Savient of BTG’s desire be reasonably requested by such Party, to take the lead role extent possible, having its employees testify when requested and making available relevant records, papers, information, samples, specimens and the like. To the extent either Party incurs any Losses arising from or in the defense of connection with any such Product Liability Claim. IfClaim with respect to the Licensed Product that is not otherwise subject to indemnification by a Party under Section 12.1, within ten (10) days after BTG notifies Savient 12.2 or 12.3 of this Agreement, such desire, Savient does not assume the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) shall consult with the other Party on all material aspects of the defense, including without limitation settlement, of such Product Liability Claim, and the Parties shall cooperate fully with each other in connection therewith. The non-defending Party shall also have the right to participate in the defense of any Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and defense of each Product Liability Claim. The Controlling Party will otherwise keep the other Party fully informed of the status and progress of the defense and any settlement discussions concerning the Product Liability Claim. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, Losses shall be subject to the prior written approval of both Parties, such approval not to be unreasonably withheld or delayed. All damages shared [***]% by NovaDel and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties in accordance with Section 12.04 (i)[***]% by PAR.
Appears in 2 contracts
Samples: Development and Commercialization Sublicense Agreement (Hana Biosciences Inc), Development and Commercialization Sublicense Agreement (Novadel Pharma Inc)
Product Liability Claims. Notwithstanding the foregoing Sections 12.02 17.7.1 Other than CLAIMS for which AVENTIS is obligated to indemnify GENTA under Section 17.4 above, or for which GENTA is obligated to indemnify AVENTIS (*) Represents language that is redacted and 12.03subject to Confidential Treatment. under Section 17.5 above, the Parties’ responsibilities with respect Parties shall share responsibility for all LOSSES arising out of or resulting from any and all CLAIMS of THIRD PARTIES concerning PRODUCT sold in the United States by AVENTIS or its AFFILIATES or their MARKETING DISTRIBUTORS during the term of this AGREEMENT (and, if applicable, during any Trailing Period) that involve death or bodily injury to any individual, including, without limitation, any product liability actions (collectively, "U.S. Product Liability Claims shall be governed by Claims") as set forth in this Section12.04Section 17.7.
(i) BTG shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect.
(ii) 17.7.2 Each Party shall give the other prompt written notice of any U.S. Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.0417.7, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each U.S. Product Liability Claim, Savient the Parties shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim determine by mutual agreement, within ninety twenty (9020) days following Savient’s their receipt of notice of the commencement of or assertion of such U.S. Product Liability Claim, BTG Claim (or such lesser period of time as may notify Savient of BTG’s desire be required to take properly respond to such claim) which Party shall assume the lead role in the defense thereof. Should the Parties be unable to mutually agree on who shall assume the lead role in the defense of such Product Liability Claim. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume the defense of such any U.S. Product Liability Claim, then BTG may take AVENTIS shall be entitled to assume such role, and if AVENTIS declines or fails to diligently assume such role, GENTA shall be entitled to assume such role.
17.7.3 The Party assuming the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any U.S. Product Liability Claim as permitted under this Section 12.04 (the “"Controlling Party”") shall consult with the other Party on all material aspects of the defense, including including, without limitation limitation, settlement, of such Product Liability Claimclaim, the other Party shall have a reasonable opportunity to participate in decision-making with respect to the strategy of such defense, and the Parties shall reasonably cooperate fully with each other in connection therewithwith the implementation thereof. The non-defending Party shall also have the right to participate in the defense of any U.S. Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ ' cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including including, without limitation limitation, the retention of counsel and for defense of each Product Liability Claim. The Controlling Party will otherwise keep the other Party fully informed of the status and progress of the defense and any settlement discussions concerning the Product Liability Claim. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, shall be subject to the prior written approval of both Parties, such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties in accordance with Section 12.04 (i).U.S.
Appears in 1 contract
Samples: u.s. Commercialization Agreement (Genta Incorporated /De/)
Product Liability Claims. Notwithstanding 18.1 Subject to the foregoing Sections 12.02 and 12.03provisions of this Clause 18, the Parties’ responsibilities Vendor irrevocably undertakes to indemnify and keep indemnified the Purchaser and the Target Companies, as applicable (hereafter collectively referred to in this Clause 18 as the “Purchaser”) against all Product Liability Claim Losses. The Vendor shall not be liable for a Product Liability Claim Loss unless (a) it has received from the Purchaser within 12 months following Completion written notice giving reasonable details of the Product Liability Claim and (b) the amount of the Product Liability Claim Losses, when aggregated with all other Product Liability Claim Losses made on the same occasion or previously, is equal to or exceeds US$1,000,000 (in which case the Vendor shall be liable for only the excess). The deductible referred to above is separate from the deductible covering warranties and other indemnities specified in Schedule 4.
18.2 In addition, the Purchaser shall have no right to an indemnity under Clause 18.1 for any Product Liability Claim if it fails to act in accordance with Clause 18.3.
18.3 If the Purchaser or a Target Company becomes aware of any matter which might give rise to a Product Liability Claim, the following provisions shall apply:-
(a) the Purchaser shall promptly give written notice to the Vendor of the matter (stating in reasonable detail the nature of the matter and, so far as practicable, the amounts claimed by the customer) and shall consult with the Vendor with respect to the matter. If the matter has become the subject of any legal proceedings initiated by the customer, the Purchaser promptly shall deliver the notice as a matter of urgency to the Vendor. The Purchaser shall provide written notice to the Vendor of its actual and anticipated Product Liability Claims Claim Losses associated with the Product Liability Claim when they are reasonably determinable and will provide updates to the Vendor to the extent practicable;
(b) the Purchaser shall, and shall be governed by this Section12.04.procure that each Target Company shall:-
(i) BTG shall be solely responsible for take all reasonable steps to avoid and/or mitigate the total cost to resolve any Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect.Claim;
(ii) Each Party shall give the other prompt written notice of any Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.04, except without prejudice to the extent generality of Clause 18.3(b)(i), take all such steps and adopt all approaches to avoid and or minimise the financial loss suffered by the Purchaser or by the applicable Target Company (as the case may be) and, in this regard, the Purchaser agrees that the payment of cash to a customer or issuance of a credit shall only be effected when all other Party can establish actual prejudice and direct damages as avenues of settling a result thereof. With respect to each Product Liability Claim, Savient shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim within ninety have been exhausted;
(90iii) days following Savient’s receipt of notice of the commencement or assertion of such Product Liability Claim, BTG may notify Savient of BTG’s desire to take Purchaser shall involve the lead role Vendor in the defense process of such Product Liability Claim. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume reviewing and determining the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. The Party assuming the defense root cause of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) and shall consult with the Vendor prior to negotiating or settling any Product Liability Claim. Any solution or settlement of a Product Liability Claim shall embrace the principle that both the Purchaser and the Vendor will be working together to resolve such claim and will mutually agree on solutions which minimize the cost to both the Purchaser and the Vendor of the settlement with the customer without compromising the future profitability of the Wireless Infrastructure Business overall.
(c) the Purchaser shall provide to the Vendor and its professional advisers reasonable access to premises and personnel and to any relevant assets, documents and records within the possession or control of it or any Target Company for the purposes of investigating the matter and enabling the Vendor to take any actions contemplated by this Clause 18;
(d) the Vendor, at its expense, shall be entitled to take copies of any documents or records, and photograph any premises or assets, within the ownership or control of a Target Company which are necessary or related to understanding or defending a Product Liability Claim;
(e) the Vendor and the Purchaser agree to cooperate and work together to resolve all Product Liability Claims on a case by case basis in accordance with the principles set out in this clause 18.3 and in a manner which is consistent with maintaining an ongoing business relationship with the customer bringing the claim. Examples of possible solutions to a Product Liability Claim and the corresponding financial treatment are given below: (i) if a new product is supplied at zero sales value, which would have been supplied independently of the specific product liability claim, then Vendor would be responsible for the full value of the product supplied as part of the Product Liability Claim; (ii) mitigation of the Product Liability Claim Losses by offering internal engineering design effort or other Party similar services on the product or other proposed products for the customer, which would normally be provided without cost to the customer, is to be borne within the indirect costs of the Purchaser or the applicable Target Company, so not forming part of the Product Liability Claim Losses. For purposes of clarification, costs paid to third parties, for example to respin boards or to purchase material or to produce new products, are not considered internal engineering design efforts; (iii) the supply of the new product or Re-Works in warranty to replace the faulty product will be paid by the Vendor at such amount as equals the direct cost of manufacture (which includes any directly allocable manufacturing overhead costs associated with such product) provided the methods and means of such manufacture (and the methodology of allocating overhead costs) follow the same (or the same in all material aspects respects) methods, means and methodology as are adopted or utilised by the Target Companies and Comtek in the ordinary course of business prior to Completion; (iv) any net benefit arising under the definition of “Corresponding Benefit” will be credited to the Vendor when assessing the net value of the defense, including without limitation settlement, of such Product Liability Claim Losses.
18.4 If the Vendor makes a payment to the Purchaser in relation to a Product Liability Claim, and the Parties shall cooperate fully with each other in connection therewith. The non-defending Party shall also have the right Purchaser or a Target Company subsequently recovers from a third party any sum which is referable to participate in the defense of any Product Liability Claim utilizing attorneys of its choicea fact, at its own expense. In furtherance of the Parties’ cooperationmatter, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and defense of each event or circumstance giving rise to a Product Liability Claim. The Controlling Party will , the Purchaser shall, or, as appropriate, shall procure that the applicable Target Company shall, pay to the Vendor an amount equal to the amount that the Purchaser or the relevant Target Company received from the third party, after deducting an amount equal to the reasonable costs of the Purchaser or the relevant Target Company incurred in recovering such receipt.
18.5 For the avoidance of doubt (and so as to take priority over the provisions of clause 24 and the definition of Retained Liabilities, but otherwise keep without prejudice to the other Party fully informed provisions of this Agreement and in particular the provisions of this clause 18), in the event that a customer or former customer of a Target Company or of any member of the status and progress Filtronic Group makes a claim or claims after Completion against any member of the defense and any settlement discussions concerning the Product Liability Claim. Any settlement of a Product Liability Claim that would admit liability on the part Filtronic Group in respect of any Party supply of any product supplied in the course of the Wireless Infrastructure Business (and so that for the purposes of this clause 18.5 the term Wireless Infrastructure Business shall mean the Wireless Infrastructure Business as conducted in the period up to Completion, as opposed to as at the date hereof and as at Completion) (“Historic WIB Claims”) the Purchaser shall co-operate with the Vendor so as to ensure that the Purchaser shall assume responsibility for Historic WIB Claims and the Purchaser shall indemnify the Vendor (for itself and as trustee for each member of the Filtronic Group) against all actions, proceedings, claims, demands and reasonable costs arising directly or its Affiliates indirectly in respect of such Historic WIB Claims.
18.6 No admission of liability, compromise or Agents, or that would involve any relief other than the payment of money damages, agreement shall be subject to made by any member of the Filtronic Group or any third party acting on behalf of any member of the Filtronic Group regarding any Historic WIB Claims without the prior written approval consent of both Parties, the Purchaser (such approval consent not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties in accordance with Section 12.04 (i).
Appears in 1 contract
Samples: Share Purchase Agreement (Powerwave Technologies Inc)
Product Liability Claims. Notwithstanding the foregoing Sections 12.02 and 12.0317.7.1. Other than CLAIMS for which AVENTIS is obligated to indemnify GENTA under Section 17.4 above, or for which GENTA is obligated to indemnify AVENTIS under Section 17.5 above, the Parties’ responsibilities with respect Parties shall share responsibility for all LOSSES arising out of or resulting from any and all CLAIMS of THIRD PARTIES concerning PRODUCT sold in the United States by AVENTIS or its AFFILIATES or their MARKETING DISTRIBUTORS during the term of this AGREEMENT (and, if applicable, during any Trailing Period) that involve death or bodily injury to any individual, including, without limitation, any product liability actions (collectively, "U.S. Product Liability Claims shall be governed by Claims") as set forth in this Section12.04Section 17.7.
(i) BTG shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect17.7.2. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect.
(ii) Each Party shall give the other prompt written notice of any U.S. Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.0417.7, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each U.S. Product Liability Claim, Savient the Parties shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim determine by mutual agreement, within ninety twenty (9020) days following Savient’s their receipt of notice of the commencement of or assertion of such U.S. Product Liability Claim, BTG Claim (or such lesser period of time as may notify Savient of BTG’s desire be required to take properly respond to such claim) which Party shall assume the lead role in the defense thereof. Should the Parties be unable to mutually agree on who shall assume the lead role in the defense of such Product Liability Claim. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume the defense of such any U.S. Product Liability Claim, then BTG may take AVENTIS shall be entitled to assume such role, and if AVENTIS declines or fails to diligently assume such role, GENTA shall be entitled to assume such role.
17.7.3. The Party assuming the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any U.S. Product Liability Claim as permitted under this Section 12.04 (the “"Controlling Party”") shall consult with the other Party on all material aspects of the defense, including including, without limitation limitation, settlement, of such Product Liability Claimclaim, the other Party shall have a reasonable opportunity to participate in decision-making with respect to the strategy of such defense, and the Parties shall reasonably cooperate fully with each other in connection therewithwith the implementation thereof. The non-defending Party shall also have the right to participate in the defense of any U.S. Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ ' cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including including, without limitation limitation, the retention of counsel and for defense of each Product Liability Claim. The Controlling Party will otherwise keep the other Party fully informed of the status and progress of the defense and any settlement discussions concerning the Product Liability Claim. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, shall be subject to the prior written approval of both Parties, such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties in accordance with Section 12.04 (i).U.S.
Appears in 1 contract
Product Liability Claims. Notwithstanding (a) Bayer hereby agrees to Indemnify the foregoing Sections 12.02 Nuvelo Indemnitees from and 12.03, the Parties’ responsibilities with respect to against any and all Losses arising from Product Liability Claims shall be governed by this Section12.04.
(i) BTG in the Bayer Territory and Nuvelo hereby agrees to Indemnify the Bayer Indemnitees from and against any and all Losses arising from Product Liability Claims in the Nuvelo Territory, except as follows: Each Party shall be solely responsible for all Product Liability Claims resulting from, and to the extent allocable to, (i) such Party’s or its Affiliate’s material failure to adhere to the terms of any Development or Commercialization plan approved by the JSC, (ii) the distribution by such Party or its Affiliate of Promotional Materials that arise out fall outside the guidelines established by the JSC, (iii) the making of any claim or representation in respect of the Licensed Product or the respective characteristics thereof by or on behalf of such Party or its Affiliate (by members of its sales force or otherwise) that have not been approved by the JSC or which do not represent an accurate summary or explanation of the labeling of the Licensed Product or a portion thereof or (iv) Non-Conforming Bulk ProductConformance of the Licensed Product where, providedwith respect to Bayer, howeversuch Non-Conformance occurred after such Licensed Product was delivered to Bayer by Nuvelo and, that the following conditions are cumulatively satisfied: (A) with respect to Nuvelo, such nonconformance Non-Conformance existed at the time the Bulk such Licensed Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden DefectNuvelo.
(iib) Each Party shall give the other prompt written notice of any Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.0414.4, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each Product Liability Claim, Savient Nuvelo shall have the first right to defend and settle such Product Liability Claim. In the event that Savient Nuvelo does not assume the defense of such Product Liability Claim within ninety (90) days following SavientNuvelo’s receipt of notice of the commencement or assertion of such Product Liability Claim, BTG may notify Savient of BTG’s desire Bayer shall have the right, but not the obligation, to take the lead role in the defense of such Product Liability Claim. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any Product Liability Claim as permitted under this Section 12.04 14.4 (the “Controlling Party”) shall consult with the other Party on all material aspects of the defense, including without limitation settlement, of such Product Liability Claim, defense and the Parties shall cooperate fully with each other in connection therewith. The non-defending Party shall also have the right to participate in the defense of any Product Liability Claim utilizing using attorneys of its choice, at its own expense. In furtherance of the Parties’ cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and defense of each Product Liability Claim. The Controlling Party will otherwise keep the other Party fully informed of the status and progress of the defense and any settlement discussions concerning the Product Liability Claim. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or AgentsAffiliates, or that would involve any relief other than the payment of money damagesdamages within a budget previously agreed to by the Parties, shall be subject to the prior written approval of both Parties, such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties Nuvelo and Bayer in accordance with Section 12.04 (i14.4(a).
Appears in 1 contract
Product Liability Claims. Notwithstanding Other than Claims for which either Party is obligated to indemnify the foregoing Sections 12.02 and 12.03other Party under Section 13.2 or 13.3, the Parties’ responsibilities with respect following shall apply to Losses arising out of or resulting from any Product Liability Claims shall be governed by this Section12.04Claim, regardless of legal theory.
(i) BTG shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect.
(iia) Each Party shall give the other prompt written notice of any Product Liability Claim, but the omission of failure to provide such prompt notice shall not relieve either any Party from its obligations under this Section 12.04, except of the duty to defend or indemnify unless such failure materially prejudices the extent the other Party can establish actual prejudice and direct damages as a result thereofdefense of any matter. With respect to each Product Liability Claim, Savient the Parties shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim determine by mutual agreement, within ninety twenty (9020) days following Savient’s their receipt of notice of the commencement of or assertion of such Product Liability Claim, BTG Claim (or such lesser period of time as may notify Savient of BTG’s desire be required to take the lead role in the defense of properly respond to such Product Liability Claim) which Party shall undertake the defense thereof. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume Should the Parties be unable to agree on who shall undertake the defense of such any Product Liability Claim, then BTG may take Esprit shall be entitled to assume such role, provided, however, that absent an agreement by the lead Parties to the contrary, Indevus shall reimburse Esprit for fifty percent (50%) of defense costs, including reasonable fees of attorneys, accountants or other experts retained by Esprit, as incurred, and if Esprit declines or fails to assume such role, Indevus shall be entitled to assume such role in the and Esprit shall reimburse Indevus for fifty percent (50%) of defense costs, including reasonable fees of such Product Liability Claim. attorneys, accountants or other experts retained by Indevus, as incurred.
(b) The Party assuming undertaking the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) shall consult with the other Party on all material aspects of the defense, including without limitation settlement, of such Product Liability Claim, and the other Party shall have a reasonable opportunity to participate in decision-making with respect to the strategy of such defense, and the Parties shall reasonably cooperate fully with each other in connection therewithwith the implementation thereof. The non-defending Controlling Party shall also have the right to participate in the defense of any Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and for defense of each any Product Liability Claim. The Controlling Party will otherwise keep the other Party fully reasonably informed of the status and progress of the defense and any settlement discussions concerning each Product Liability Claim, and the Parties shall provide each other with all reasonably requested assistance and will reasonably cooperate with each other in connection therewith. Each Party agrees that it will take reasonable steps to minimize the burdens of the litigation on witnesses and on the ongoing business of the Indemnified Parties including making reasonable accommodations to witnesses’ schedules when possible and seeking appropriate protective orders limiting the duration and/or location of depositions.
(c) The Parties shall negotiate in good faith to enter into a joint defense agreement as soon as reasonably practicable after the commencement of any Product Liability Claim which agreement shall, among other things: (i) establish procedures to allocate between the Parties the responsibility for Losses arising out of or resulting from Product Liability Claims (giving effect to, among other factors, the nature of the Product Liability Claim. Any ); (ii) establish procedures as are reasonably necessary to permit the Parties to reconcile their actual payments for such Losses with their allocable share of responsibility for such Losses on a quarterly basis; and (iii) provide for procedures with respect to any settlement of a Product Liability Claim; provided, however, that (x) to the extent it is shown by evidence acceptable in a court of law having jurisdiction over the subject matter and meeting the appropriate degree of proof for such Product Liability Claim that would admit liability on the part Losses resulting from such Product Liability Claim resulted from the manufacture of any Party Products by or through Indevus or its Affiliates or Agentsany of their respective employees, agents, contractors, representatives or that would involve any relief other than the payment persons or entities working on their behalf, then Indevus shall bear financial responsibility for all such Losses, unless Esprit agrees to control and bear financial responsibility of money damages, shall be subject such defense and Product Liability Claim; (y) to the prior written approval extent it is shown by evidence acceptable in a court of both Parties, law having jurisdiction over the subject matter and meeting the appropriate degree of proof for such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim that the Losses resulting from such Product Liability Claim resulted from the manufacture of Products by or through Esprit or its Affiliates or any of their respective employees, agents, contractors, representatives or other persons or entities working on their behalf, then Esprit shall bear financial responsibility for all such Losses, unless Indevus agrees to control and bear financial responsibility of such defense and Product Liability Claim; and (z) if the Parties are unable to agree to a mutually acceptable joint defense agreement, the matter shall be allocated between submitted to binding arbitration for resolution.
(d) Product Liability Claims shall be governed exclusively by the Parties provisions of this Section 13.6 and, except in accordance with this Section 12.04 (i)13.6, neither Party shall seek from the other Party any indemnity or other recovery on account of any such Product Liability Claims; provided, however, that nothing in this Section 13.6 shall limit either Party’s liability to the other Party for damages on account of any breach by such Party of its representations, warranties, covenants or agreements under this Agreement.
Appears in 1 contract
Product Liability Claims. Notwithstanding the foregoing Sections 12.02 and 12.03, the Parties’ responsibilities with respect to Product Liability Claims shall be governed by this Section12.04.
(ia) BTG Bayer shall be solely responsible for all Product Liability Claims that arise Indemnifiable Losses arising out of Nonor relating to all Claims of Third Parties for personal injury, death or other Co-Conforming Bulk Promotion Collaboration Product liability, and all associated Indemnifiable Losses, to the extent Onyx can establish that such personal injury, death or other Co-Promotion Collaboration Product liability and all associated Indemnifiable Losses were caused by (i) Bayer’s negligent acts or omissions, or willful misconduct (including, without limitation, any willful breach of this Agreement), or (ii) the manufacturing, marketing, promotion or other commercialization of the Co-Promotion Collaboration Product by Bayer in a manner that is unlawful or inconsistent with the approved Co-Promotion Collaboration Product labeling for such Co-Promotion Collaboration Product, ; provided, however, that in no event shall Bayer be liable hereunder to the following conditions are cumulatively satisfied: (A) extent any such nonconformance existed at Claim arises out of Bayer’s promotion of the time the Bulk Co-Promotion Collaboration Product was delivered by BTG in accordance with approved Co-Promotion Collaboration Product labels and (B) such nonconformance was the result Claim is based on a theory of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and warn.
(Cb) such Non-Conformance was the result of a Hidden Defect. Savient Onyx shall be solely responsible for all Product Liability Claims that arise Indemnifiable Losses arising out of Nonor relating to all Claims of Third Parties for personal injury, death or other Co-Conforming Bulk Promotion Collaboration Product liability, and all associated Indemnifiable Losses, to the extent Bayer can establish that such personal injury, death or other Co-Promotion Collaboration Product liability and all associated Indemnifiable Losses were caused by (i) Onyx’s negligent acts or omissions, or willful misconduct (including, without limitation, any willful breach of this Agreement), or (ii) the marketing, promotion or other commercialization of the Co-Promotion Collaboration Product by Onyx in a manner that is unlawful or inconsistent with the approved Co-Promotion Collaboration Product labeling for such Co-Promotion Collaboration Product; provided, however, that in no event shall Onyx be liable hereunder to the extent any such Claim arises out of Onyx’s promotion of the Co-Promotion Collaboration Product in accordance with approved Co-Promotion Collaboration Product labels and such Claim is based on a theory of failure to warn.
(c) In addition to the obligations set forth in Section 12.2, Bayer shall defend, indemnify and hold harmless each of the following cases: (A) such nonOnyx Indemnified Parties from and against all Claims of Third Parties for personal injury, death or other Co-conformance occurred after the Bulk Promotion Collaboration Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defectliability, and all associated Indemnifiable Losses, for which Bayer is responsible under Section 12.3(a).
(iid) In addition to the obligations set forth in Section 12.1, Onyx shall defend, indemnify and hold harmless each of the Bayer Indemnified Parties from and against all Claims of Third Parties for personal injury, death or other Co-Promotion Collaboration Product liability, and all associated Indemnifiable Losses, for which Onyx is responsible under Section 12.3(b).
(e) Each Party of Bayer and Onyx shall give the other prompt written notice of any Claims within the scope of Sections 12.3(c) or 12.3(d) (each a “Product Liability Claim”), but the omission of such notice shall not relieve either Party any party from its obligations under this Section 12.0412.3, except to the extent the other Party party can establish actual prejudice and direct damages as a result thereof. With respect to each Product Liability Claim, Savient shall have the first right to defend and settle such Product Liability Claim. In party who is responsible for indemnifying the event that Savient does not assume the defense of other party against such Product Liability Claim within ninety (90pursuant to Section 12.3(c) days following Savient’s receipt of notice of the commencement or assertion of such Product Liability ClaimSection 12.3(d), BTG may notify Savient of BTG’s desire to take as applicable, shall assume the lead role in the defense of such Product Liability Claim. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) ). The Controlling Party shall consult with the other Party party on all material aspects of the defense, including including, without limitation limitation, settlement, of such Product Liability Claim, and the Parties other party shall have a full opportunity to participate in decision-making with respect to the strategy of such defense, and both parties shall cooperate fully with each other in connection therewith. The non-defending Party party shall also have the right to participate in the defense of any Product Liability Claim Claim, utilizing attorneys of its choice, at its own expense. In furtherance of the Partiesparties’ cooperation, the Controlling Party will consult with the other Party party regarding strategic decisions, including including, without limitation limitation, the retention of counsel and defense of each Product Liability Claim. The Controlling Party will otherwise keep the other Party party fully informed of the status and progress of the defense and any settlement discussions concerning the Product Liability Claim. Any The settlement of a Product Liability Claim that would admit liability on the part of any Party party or its Affiliates or AgentsAffiliates, or that would involve any relief other than the payment of money damagesdamages within a budget previously agreed to by the parties, or that would not include a full and unconditional release of the parties subject thereto shall be subject to the prior written approval of both Partiessuch parties, such approval not to be unreasonably withheld or delayed. All damages and expenses .
(including attorney’s feesf) incurred in connection with the defense Losses arising out of or relating to Claims of Third Parties for personal injury, death or other Co-Promotion Collaboration Product liabilities that are not covered by Sections 12.3(a) or 12.3(b) (such as Losses arising from a Product Liability Claim failure to warn) shall be allocated between shared by the Parties parties as Allowable Co-Promotion Expenses (or, in accordance with Section 12.04 the event of any termination of this Agreement under Sections 7.4(d) or 10.5(c)(i) or (iii) hereof, deducted by the party paying the royalties or payments described thereunder).
Appears in 1 contract
Product Liability Claims. Notwithstanding the foregoing Sections 12.02 and 12.03, the Parties’ ' responsibilities with respect to Product Liability Claims shall be governed by this Section12.04.
(i) BTG shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance nonconformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming NonConforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect.
(ii) Each Party shall give the other prompt written notice of any Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.04, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each Product Liability Claim, Savient shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim within ninety (90) days following Savient’s 's receipt of notice of the commencement or assertion of such Product Liability Claim, BTG may notify Savient of BTG’s 's desire to take the lead role in the defense of such Product Liability Claim. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any Product Liability Claim as permitted under this Section 12.04 (the “"Controlling Party”") shall consult with the other Party on all material aspects of the defense, including without limitation settlement, of such Product Liability Claim, and the Parties shall cooperate fully with each other in connection therewith. The non-defending Party shall also have the right to participate in the defense of any Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ ' cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and defense of each Product Liability Claim. The Controlling Party will otherwise keep the other Party fully informed of the status and progress of the defense and any settlement discussions concerning the Product Liability Claim. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, shall be subject to the prior written approval of both Parties, such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties in accordance with Section 12.04 (i).
Appears in 1 contract
Samples: Commercial Supply Agreement (Savient Pharmaceuticals Inc)
Product Liability Claims. Notwithstanding Other than Claims for which either Party is obligated to indemnify the foregoing Sections 12.02 and 12.03other Party under Section 13.2 or 13.3, the Parties’ responsibilities with respect following shall apply to Losses arising out of or resulting from any Product Liability Claims shall be governed by this Section12.04Claim, regardless of legal theory.
(i) BTG shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect.
(iia) Each Party shall give the other prompt written notice of any Product Liability Claim, but the omission of failure to provide such prompt notice shall not relieve either any Party from its obligations under this Section 12.04, except of the duty to defend or indemnify unless such failure materially prejudices the extent the other Party can establish actual prejudice and direct damages as a result thereofdefense of any matter. With respect to each Product Liability Claim, Savient the Parties shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim determine by mutual agreement, within ninety twenty (9020) days following Savient’s their receipt of notice of the commencement of or assertion of such Product Liability Claim, BTG Claim (or such lesser period of time as may notify Savient of BTG’s desire be required to take the lead role in the defense of properly respond to such Product Liability Claim) which Party shall undertake the defense thereof. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume Should the Parties be unable to agree on who shall undertake the defense of such any Product Liability Claim, then BTG may take Esprit shall be entitled to assume such role, provided, however, that absent an agreement by the lead Parties to the contrary, Indevus shall reimburse Esprit for fifty percent (50%) of defense costs, including reasonable fees of attorneys, accountants or other experts retained by Esprit, as incurred, and if Esprit declines or fails to assume such role, Indevus shall be entitled to assume such role in the and Esprit shall reimburse Indevus for fifty percent (50%) of defense costs, including reasonable fees of such Product Liability Claim. attorneys, accountants or other experts retained by Indevus, as incurred.
(b) The Party assuming undertaking the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) shall consult with the other Party on all material aspects of the defense, including without limitation settlement, of such Product Liability Claim, and the other Party shall have a reasonable opportunity to participate in decision-making with respect to the strategy of such defense, and the Parties shall reasonably cooperate fully with each other in connection therewithwith the Confidential treatment has been requested for portions of this document. This copy of the document filed as an Exhibit omits the confidential information subject to the confidentiality request. Omissions are designated by the symbol [...***...]. A complete version of this document has been provided separately to the Securities and Exchange Commission. implementation thereof. The non-defending Controlling Party shall also have the right to participate in the defense of any Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and for defense of each any Product Liability Claim. The Controlling Party will otherwise keep the other Party fully reasonably informed of the status and progress of the defense and any settlement discussions concerning each Product Liability Claim, and the Parties shall provide each other with all reasonably requested assistance and will reasonably cooperate with each other in connection therewith. Each Party agrees that it will take reasonable steps to minimize the burdens of the litigation on witnesses and on the ongoing business of the Indemnified Parties including making reasonable accommodations to witnesses’ schedules when possible and seeking appropriate protective orders limiting the duration and/or location of depositions.
(c) The Parties shall negotiate in good faith to enter into a joint defense agreement as soon as reasonably practicable after the commencement of any Product Liability Claim which agreement shall, among other things: (i) establish procedures to allocate between the Parties the responsibility for Losses arising out of or resulting from Product Liability Claims (giving effect to, among other factors, the nature of the Product Liability Claim. Any ); (ii) establish procedures as are reasonably necessary to permit the Parties to reconcile their actual payments for such Losses with their allocable share of responsibility for such Losses on a quarterly basis; and (iii) provide for procedures with respect to any settlement of a Product Liability Claim; provided, however, that (x) to the extent it is shown by evidence acceptable in a court of law having jurisdiction over the subject matter and meeting the appropriate degree of proof for such Product Liability Claim that would admit liability on the part Losses resulting from such Product Liability Claim resulted from the manufacture of any Party Products by or through Indevus or its Affiliates or Agentsany of their respective employees, agents, contractors, representatives or that would involve any relief other than the payment persons or entities working on their behalf, then Indevus shall bear financial responsibility for all such Losses, unless Esprit agrees to control and bear financial responsibility of money damages, shall be subject such defense and Product Liability Claim; (y) to the prior written approval extent it is shown by evidence acceptable in a court of both Parties, law having jurisdiction over the subject matter and meeting the appropriate degree of proof for such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim that the Losses resulting from such Product Liability Claim resulted from the manufacture of Products by or through Esprit or its Affiliates or any of their respective employees, agents, contractors, representatives or other persons or entities working on their behalf, then Esprit shall bear financial responsibility for all such Losses, unless Indevus agrees to control and bear financial responsibility of such defense and Product Liability Claim; and (z) if the Parties are unable to agree to a mutually acceptable joint defense agreement, the matter shall be allocated between submitted to binding arbitration for resolution.
(d) Product Liability Claims shall be governed exclusively by the Parties provisions of this Section 13.6 and, except in accordance with this Section 12.04 (i)13.6, neither Party shall seek from the other Party any indemnity or other recovery on account of any such Product Liability Claims; provided, however, that nothing in this Section 13.6 shall limit either Party’s liability to the other Party for damages on account of any breach by such Party of its representations, warranties, covenants or agreements under this Agreement.
Appears in 1 contract
Samples: Merger Agreement (Allergan Inc)
Product Liability Claims. Notwithstanding Other than Claims for which either Party is obligated to indemnify the foregoing Sections 12.02 and 12.03other Party under Section 13.2 or 13.3, the Parties’ responsibilities with respect following shall apply to Losses arising out of or resulting from any Product Liability Claims shall be governed by this Section12.04Claim, regardless of legal theory.
(i) BTG shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defect.
(iia) Each Party shall give the other prompt written notice of any Product Liability Claim, but the omission of failure to provide such prompt notice shall not relieve either any Party from its obligations under this Section 12.04, except of the duty to defend or indemnify unless such failure materially prejudices the extent the other Party can establish actual prejudice and direct damages as a result thereofdefense of any matter. With respect to each Product Liability Claim, Savient the Parties shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim determine by mutual agreement, within ninety twenty (9020) days following Savient’s their receipt of notice of the commencement of or assertion of such Product Liability Claim, BTG Claim (or such lesser period of time as may notify Savient of BTG’s desire be required to take the lead role in the defense of properly respond to such Product Liability Claim) which Party shall undertake the defense thereof. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume Should the Parties be unable to agree on who shall undertake the defense of such any Product Liability Claim, then BTG may take Odyssey shall be entitled to assume such role, provided, however, that absent an agreement by the lead Parties to the contrary, Indevus shall reimburse Odyssey for [*] of defense costs, including reasonable fees of attorneys, accountants or other experts retained by Odyssey, as incurred, and if Odyssey declines or fails to assume such role, Indevus shall be entitled to assume such role in the and Odyssey shall reimburse Indevus for [*] of defense costs, including reasonable fees of such Product Liability Claim. attorneys, accountants or other experts retained by Indevus, as incurred.
(b) The Party assuming undertaking the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) shall consult with the other Party on all material aspects of the defense, including including, without limitation settlementlimitation, settlement of such Product Liability Claim, and the other Party shall have a reasonable opportunity to participate in decision-making with respect to the strategy of such defense, and the Parties shall reasonably cooperate fully with each other in connection therewithwith the implementation thereof. The non-defending Controlling Party shall also have the right to participate in the defense of any Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including including, without limitation limitation, the retention of counsel and for defense of each any Product Liability Claim. The Controlling Party will otherwise keep the other Party fully reasonably informed of the status and progress of the defense and any settlement discussions concerning each Product Liability Claim, and the Parties shall provide each other with all reasonably requested assistance and will reasonably cooperate with each other in connection therewith. Each Party agrees that it will take reasonable steps to minimize the burdens of the litigation on witnesses and on the ongoing business of the Indemnified Parties including, without limitation, making reasonable accommodations to witnesses’ schedules when possible and seeking appropriate protective orders limiting the duration and/or location of depositions.
(c) The Parties shall negotiate in good faith to enter into a joint defense agreement as soon as reasonably practicable after the commencement of any Product Liability Claim which agreement shall, among other things, (i) establish procedures to allocate between the Parties the responsibility for Losses arising out of or resulting from Product Liability Claims (giving effect to, among other factors, the nature of the Product Liability Claim. Any Claim and the relative rights, interests and obligations of the Parties under this Agreement); (ii) establish procedures as are reasonably necessary to permit the Parties to reconcile their actual payments for such Losses with their allocable share of responsibility for such Losses on a quarterly basis; and (iii) provide for procedures with respect to any settlement of a Product Liability Claim, provided, however, that (x) to the extent it is shown by evidence acceptable in a court of law having jurisdiction over the subject matter and meeting the appropriate degree of proof for such Product Liability Claim that would admit liability on the part Losses resulting from such Product Liability Claim resulted from the manufacture of any Party Product by or through Indevus or its Affiliates or Agentsany of their respective employees, agents, contractors, representatives or that would involve any relief other than the payment persons or entities working on their behalf, then Indevus shall bear financial responsibility for such Losses, unless Odyssey agrees to control and bear financial responsibility of money damages, shall be subject such defense and Product Liability Claim; (y) to the prior written approval extent it is shown by evidence acceptable in a court of both Parties, law having jurisdiction over the subject matter and meeting the appropriate degree of proof for such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim that the Losses resulting from such Product Liability Claim resulted from the manufacture of Product by or through Odyssey or its Affiliates or any of their respective employees, agents, contractors, representatives or other persons or entities working on their behalf, then Odyssey shall bear financial responsibility for such Losses, unless Indevus agrees to control and bear financial responsibility of such defense and Product Liability Claim; and (z) if the Parties are unable to agree to a mutually acceptable joint defense agreement, the matter shall be allocated between submitted to binding arbitration for resolution.
(d) Product Liability Claims shall be governed exclusively by the Parties provisions of this Section 13.7 and, except in accordance with this Section 12.04 (i)13.7, neither Party shall seek from the other Party any indemnity or other recovery on account of any such Product Liability Claims; provided, however, that nothing in this Section 13.7 shall limit either Party’s liability to the other Party for damages on account of any breach by such Party of its representations, warranties, covenants or agreements under this Agreement.
Appears in 1 contract
Product Liability Claims. Notwithstanding the foregoing Sections 12.02 and 12.0315.7.1 Other than CLAIMS for which AVENTIS is obligated to indemnify GENTA under Section 15.4 above, the Parties’ responsibilities with respect or for which GENTA is obligated to Product Liability Claims indemnify AVENTIS under Section 15.5 above, AVENTIS shall be governed by this Section12.04.
(i) BTG shall be solely responsible for all LOSSES arising out of or resulting from any and all CLAIMS of THIRD PARTIES concerning PRODUCT sold in the ROW by AVENTIS, its AFFILIATES or their MARKETING DISTRIBUTORS that involve death or bodily injury to any individual, including, without limitation, any product liability actions (collectively, "ROW Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (AClaims") such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product as set forth in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defectthis Section 15.7.
(ii) 15.7.2 Each Party shall give the other prompt written notice of any ROW Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.0415.7, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each ROW Product Liability Claim, Savient AVENTIS shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume be solely responsible for the defense of such Product Liability Claim within ninety (90) days following Savient’s receipt of notice of the commencement or assertion of such Product Liability Claim, BTG may notify Savient of BTG’s desire to take the lead role in the defense of such Product Liability Claim. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) thereof.
15.7.3 AVENTIS shall consult with the other Party GENTA on all material aspects of the defense, including including, without limitation limitation, settlement, of such Product Liability Claimclaim, and the Parties GENTA shall reasonably cooperate fully with each other AVENTIS in connection therewithwith the implementation thereof. The non-defending Party GENTA shall also have the right to participate in the defense of any ROW Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and defense of each Product Liability Claim. The Controlling Party AVENTIS will otherwise keep the other Party fully GENTA reasonably informed of (*) Represents language that is redacted and subject to Confidential Treatment. the status and progress of the defense and any settlement discussions concerning the each ROW Product Liability ClaimClaim and GENTA shall provide AVENTIS with all reasonably requested assistance and will reasonably cooperate with AVENTIS in connection therewith. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, shall be subject to the prior written approval of both Parties, such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a ROW Product Liability Claim shall be allocated between require AVENTIS' written consent.
15.7.4 The Parties shall establish such procedures as are reasonably necessary to permit AVENTIS to reconcile its payment to GENTA for GENTA's actual payments for such LOSSES, if any, within sixty (60) days following the Parties in accordance with Section 12.04 (i)end of each CALENDAR QUARTER.
Appears in 1 contract
Samples: Ex u.s. Commercialization Agreement (Genta Incorporated /De/)
Product Liability Claims. Notwithstanding the foregoing Sections 12.02 and 12.0315.7.1. Other than CLAIMS for which AVENTIS is obligated to indemnify GENTA under Section 15.4 above, the Parties’ responsibilities with respect or for which GENTA is obligated to Product Liability Claims indemnify AVENTIS under Section 15.5 above, AVENTIS shall be governed by this Section12.04.
(i) BTG shall be solely responsible for all LOSSES arising out of or resulting from any and all CLAIMS of THIRD PARTIES concerning PRODUCT sold in the ROW by AVENTIS, its AFFILIATES or their MARKETING DISTRIBUTORS that involve death or bodily injury to any individual, including, without limitation, any product liability actions (collectively, "ROW Product Liability Claims that arise out of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (AClaims") such nonconformance existed at the time the Bulk Product was delivered by BTG and (B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product as set forth in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect. Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the Process or (C) such Non-Conformance was not the result of a Hidden Defectthis Section 15.7.
(ii) 15.7.2. Each Party shall give the other prompt written notice of any ROW Product Liability Claim, but the omission of such notice shall not relieve either Party from its obligations under this Section 12.0415.7, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each ROW Product Liability Claim, Savient AVENTIS shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume be solely responsible for the defense of such Product Liability Claim within ninety (90) days following Savient’s receipt of notice of the commencement or assertion of such Product Liability Claim, BTG may notify Savient of BTG’s desire to take the lead role in the defense of such Product Liability Claimthereof.
15.7.3. If, within ten (10) days after BTG notifies Savient of such desire, Savient does not assume the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. The Party assuming the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) AVENTIS shall consult with the other Party GENTA on all material aspects of the defense, including including, without limitation limitation, settlement, of such Product Liability Claimclaim, and the Parties GENTA shall reasonably cooperate fully with each other AVENTIS in connection therewithwith the implementation thereof. The non-defending Party GENTA shall also have the right to participate in the defense of any ROW Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’ cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and defense of each Product Liability Claim. The Controlling Party AVENTIS will otherwise keep the other Party fully GENTA reasonably informed of the status and progress of the defense and any settlement discussions concerning the each ROW Product Liability ClaimClaim and GENTA shall provide AVENTIS with all reasonably requested assistance and will reasonably cooperate with AVENTIS in connection therewith. Any settlement of a Product Liability Claim that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, shall be subject to the prior written approval of both Parties, such approval not to be unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a ROW Product Liability Claim shall be allocated between require AVENTIS' written consent.
15.7.4. The Parties shall establish such procedures as are reasonably necessary to permit AVENTIS to reconcile its payment to GENTA for GENTA's actual payments for such LOSSES, if any, within sixty (60) days following the Parties in accordance with Section 12.04 (i)end of each CALENDAR QUARTER.
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Samples: Ex u.s. Commercialization Agreement (Genta Inc De/)