Master Alliance Provisions Guide (MAPGuide)

Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement

  • Liability | Indemnification & liability

11. Indemnification and Liability

Entasis Indemnities 

11.1 Entasis shall defend, indemnify and hold harmless DNDi, its Affiliates and their respective directors, officers, employees and agents (the “DNDi Indemnified Parties”) from and against all Losses arising from or occurring as a result of a Third Party’s claim, action, suit, judgment or settlement to the extent such Losses arise out of:

11.1.1 the negligent conduct of the QT (TQT) Study;

11.1.2 the negligent conduct any Clinical Trial conducted by or on behalf of Entasis or its Affiliates in the context of the Collaboration Programme; 

11.1.3 any research and development activities performed by Entasis or its Affiliates outside of the Field; 

11.1.4 the Manufacture or Commercialization of the Drug Product by or on behalf of Entasis; 

11.1.5 any defects in any Drug Product either supplied by Entasis for the purpose of a Clinical Trial or supplied to DNDi or its Sublicensee by Entasis or its Sublicensee pursuant to any agreed Manufacturing and Supply Plan; and 

11.1.6 the negligence, intentional or wrongful acts or omissions or violations of law or regulation by Entasis, its Affiliates or its or their respective directors, officers or employees; and 

11.1.7 the breach by Entasis, its Affiliates or its or their respective directors, officers or employees of or the material inaccuracy of, any representation or warranty made by it in Clause 10 of this Agreement. 

The foregoing indemnity obligations shall not apply to the extent that any Losses arise from or is based on any activity for which DNDi is obligated to indemnify the Entasis Indemnified Parties under Section 11.2. 

DNDi Indemnities 

11.2 DNDi shall defend, indemnify and hold harmless Entasis, its Affiliates and its and their respective directors, officers, employees and agents (the “Entasis Indemnified Parties”) from and against all Losses arising from or occurring as a result of a Third Party’s claim, action, suit, judgment or settlement to the extent such Losses arise out of: 

11.2.1 any research and development activities performed by DNDi outside of the Field; 

11.2.2 the negligent conduct by a DNDi Indemnified Party of the Phase III MC Trial; 

11.2.3 the negligent conduct of any other Clinical Trial conducted by or on behalf of DNDi in the context of the Collaboration Programme; 

11.2.4 the Manufacture or Commercialization of the Drug Product by or on behalf of DNDi; 

11.2.5 the negligence, intentional or wrongful acts or omissions or violations of law or regulation by DNDi, its Affiliates or its or their respective directors, officers or employees; and

11.2.6 the breach by DNDi, its Affiliates or its or their respective directors, officers or employees of or the material inaccuracy of, any representation or warranty made by it in Clause 10 this Agreement. 

The foregoing indemnity obligations shall not apply to the extent that any Losses arise from or is based on any activity for which Entasis is obligated to indemnify the DNDi Indemnified Parties under Section 11.1. 

11.3 A person entitled to indemnification under Clause 11.1 or 11.2 (an “Indemnified Party”) shall give prompt written notice (the “Indemnification Claim Notice”) through a Party to this Agreement or any action, suit or proceeding relating to a Third Party claim for which indemnification may be sought (a “Third Party Claim”). Each Indemnification Claim Notice shall contain a description of the claim and the amount of any Losses claimed. The Indemnified Party shall promptly provide to the Indemnifying Party copies of all correspondence, communications and official documents (including court documents) received in respect of any such Losses. 

11.4 If required, the Indemnifying Party shall notify the insurers of the Third Party Claim and shall permit them to exercise their rights of subrogation. 

11.5 Within thirty (30) days after receipt of an Indemnification Claim Notice, the Indemnifying Party shall notify the Indemnified Party in writing whether it intends to control the defence of the Third Party Claim using its legal representatives in which case shall have sole control and responsibility for dealing with the Third Party Claim, including the right to settle the claim provided that:

11.5.1 the Indemnified Party shall be consulted and may retain its own legal representatives for proceedings at its own cost and expense; and 

11.5.2 for Losses which are not solely monetary and for which the Indemnified Party has acknowledged in writing an obligation to indemnify or if the Indemnified Party will be subject to injunctive relief, prior written consent of the Indemnified party will be required to settlement (such consent not to be unreasonably withheld).

11.6 If the Indemnifying Party does not assume control of such defence, the Indemnified Party may control such defence provided that the Indemnified Party shall not admit any liability with respect to, or settle, compromise of discharge any such Third Party Claim without the prior written consent of the Indemnifying Party (not to be unreasonably withheld). The Indemnifying Party shall not be liable for any settlement or other disposition of Losses by an Indemnified Party with respect to any Third Party Claim that is entered into without such consent. 

11.7 If the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party that is a Party to this Agreement shall, and shall cause each Indemnified Party to reasonably cooperate in the defence or prosecution thereof and shall provide all records, information and testimony, witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours by the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim, and making the Indemnified Party, its Affiliates and its and their respective directors, officers, employees and agents available on a mutually convenient basis to provide additional information and explanation of any records or information provided, and the Indemnifying Party shall reimburse the Indemnified Party for all of its related reasonable out-of-pocket expenses. 

11.8 The Party controlling the defence shall keep the other Party advised of the status of such action, suit, proceeding or claim and the defence thereof and shall consider in good faith reasonable recommendations made by the other Party with respect thereto.

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Limitation of Liability 

11.10 EXCEPT WITH RESPECT TO THIRD PARTY CLAIMS FOR WHICH A PARTY IS REQUIRED TO INDEMNIFY THE OTHER PARTY PURSUANT TO CLAUSE11.1 OR 11.2, IN NO EVENT SHALL EITHER PARTY OR ITS AFFILIATES BE LIABLE TO THE OTHER PARTY, WHETHER IN CONTRACT, TORT,NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY LOSSES SUFFERED OR INCURRED BY THE OTHER PARTY OR ITS AFFILIATES FOR ANY DIRECT OR INDIRECT LOSS OF PROFITS, BUSINESS, REVENUE OR GOODWILL OR ANY OTHER LOSSES OF A SPECIAL, NON-COMPENSATORY, CONSEQUENTIAL, INDIRECT, INCIDENTAL OR PUNITIVE NATURE INCLUDING, WITHOUT LIMITATION, INDIRECT OR CONSEQUENTIAL ECONOMIC LOSS OR LOSS OF BUSINESS VALUE. 

11.11 Nothing in this Agreement shall be taken to exclude or limit either Party’s liability to the extent that such liability cannot be excluded or limited in law including for fraud or fraudulent misrepresentations.