Master Alliance Provisions Guide (MAPGuide)

Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement

  • Liability | Representations & Warranties

Background Technology” means the IP and other rights in the DNDi Background Technology or the Entasis Background Technology respectively that were either: (i) Controlled by the relevant Party as of the Effective Date; or (ii) conceived and reduced to practice, made or developed and Controlled by a Party during the Term outside the scope of the Collaboration Programme.

DNDi Background Technology” shall mean any Background Technology of DNDi that is necessary or useful for the performance of the Collaboration Programme.

Entasis Background Technology” shall mean any Background Technology of Entasis relating to the API that is necessary or useful for the performance of the Collaboration Programme; provided, however, that if any Third Party becomes an Affiliate of Entasis after the Effective Date, Entasis Background Technology shall exclude any IP controlled by such Third Party before such Third Party became Entasis’s Affiliate.

10. Representations and Warranties

10.1 DNDi represents and warrants the following: 

10.1.1 It is duly authorized and validly existing under the laws of Switzerland and has full power and authority to enter into this Agreement and to carry out its provisions; 

10.1.2 it is duly authorized to execute and deliver this Agreement and perform its obligations hereunder; 

10.1.3 the person(s) executing this Agreement on DNDi’s behalf has/have been duly authorized to do so by all requisite corporate action; 

10.1.4 this Agreement is a legal and valid obligation binding upon DNDi and enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by DNDi will not: (i) be prevented or impaired by any agreement, instrument or understanding, oral or written to which DNDi is a party or by which itis bound; or (ii) violate any legal requirement to which it is subject; 

10.1.5 it shall perform its obligations under this Agreement in accordance with applicable laws and regulations; 

10.1.6 as of the Effective Date: (a) it is the sole and exclusive owner or licensee of the entire right title and interest in the DNDi Background Technology; (b) it has not previously entered into any agreement, whether written or oral, with respect to, or otherwise assigned, licensed, transferred, conveyed or otherwise created an encumbrance on its right title and interest in the DNDi Background Technology that would prevent DNDi from granting Entasis rights hereunder, (c) to DNDi’s knowledge, the conception, development and reduction to practice of Patent Rights and Know How relating to the DNDi Background Technology existing as of the Effective Date have not constituted or involved the misappropriation of trade secrets or other rights of property of any person; and (d) DNDi has the right, power and authority to grant all of the rights granted to Entasis hereunder; 

10.1.7 DNDi has not received any notice or threat from any Third Party asserting or alleging, nor does DNDi have any knowledge of any basis for any assertion or allegation, that use of the DNDi Background Technology would infringe the intellectual property rights of a Third Party; 

10.1.8 during the Term of this Agreement, it will not grant any right to any Third Party any right relating to any portion of the Collaboration Programme any right that would conflict with, limit or adversely affect the rights granted to Entasis hereunder; 

10.2 Entasis represents and warrants the following: 

10.2.1 It is duly authorized and validly existing under the laws of England and Wales and has full power and authority to enter into this Agreement and to carry out its provisions;

10.2.2 it is duly authorized to execute and deliver this Agreement and perform its obligations hereunder; 

10.2.3 the person(s) executing this Agreement on Entasis’s behalf has/have been duly authorized to do so by all requisite corporate action; 

10.2.4 this Agreement is a legal and valid obligation binding upon Entasis and enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by Entasis will not: (a) be prevented or impaired by any agreement, instrument or understanding, oral or written to which Entasis or its Affiliates is aparty or by which it or they are bound; or (b) violate any legal requirement to which it is or they are subject; 

10.2.5 it shall perform its obligations under this Agreement in accordance with applicable laws and regulations; 

10.2.6 as of the Effective Date, (a) it is the sole and exclusive owner or licensee of the entire right title and interest in the Entasis Background Technology, (b) it has not previously entered into any agreement, whether written or oral, with respect to, or otherwise assigned, licensed, transferred, conveyed or otherwise created an encumbrance on its right title and interest in the Entasis Background Technology that would prevent Entasis from granting DNDi rights hereunder, (c) to Entasis’s knowledge, the conception, development and reduction to practice of Patent Rights and Know How relating to the Entasis Background Technology existing as of the Effective Date have not constituted or involved the misappropriation of trade secrets or other rights of property of any person; and (d) Entasis has the right, power and authority to grant all of the rights granted to DNDi hereunder; 

10.2.7 the Entasis Patent Rights listed in Schedule 3 represent all Patent Rights within Entasis’s Control relating to the Drug Product which as of the Effective Date are necessary for DNDi to perform its obligations hereunder and enjoy the benefit of the licences and rights granted to it hereunder; 

10.2.8 Entasis has not received any notice from any Third Party asserting or alleging, nor does Entasis have any knowledge of any basis for any assertion or allegation, that use of the Entasis Background Technology would infringe the intellectual property rights of a Third Party; 

10.2.9 the Patent Rights set out in Schedule 3 that have been granted have been properly and correctly maintained in accordance with all applicable laws and all applicable fees have been paid on or before the due date for payment; and 

10.2.10 during the Term of this Agreement, it will not grant any right to any Third Party any right relating to any portion of the Collaboration Programme any right that would conflict with, limit or adversely affect the rights granted to DNDi hereunder. 

10.3 Each Party represents and warrants to the other Party that: 

10.3.1 it will not utilise in connection with the Commercialization of the Drug Product any person or entities that are debarred by any applicable Drug Regulatory Authority

10.3.2 neither that Party nor its Affiliates nor any director, officer, employee, agent or shareholder of any such person has taken any action that would violate any applicable Anti-Bribery Law nor in the last five (5) years has received any allegation of such violation or has been subjected to any investigation or inquiry by a competent authority relating to any Anti- Bribery Law and to the best of its knowledge, no such investigation or inquiry is pending or threatened; 

10.3.3 that it has instituted and maintains policies designed to ensure compliance with applicable Anti-Bribery Laws; 

10.3.4 the representations and warranties set out in this Clause 10.3 shall remain true and correct at all times; 

10.3.5 it will provide written notice to the other Party as soon as practicable and in any event within seven (7) days should such warranty fail to be true or correct. 

10.4 A breach of the representations and warranties set out in Clause 10.3 shall be considered a material breach that gives rise to an immediate termination right for the other Party on written notice. 

10.5 Each Party shall inform the other Party as soon as reasonably practicable, but in any event within fourteen (14) days, after the occurrence of any of the following events: 

10.5.1 cessation of conducting its business or trading; 

10.5.2 a Change of Control of it or any of its Affiliates; 

10.5.3 sale of all or any material portion of its assets or business to which this Agreement relates; 

10.5.4 entry of any declaratory, injunctive or other remedy or court order that would materially impair its ability to conduct its business or perform its obligations under this Agreement; 

10.5.5 any attachment or seizure (including prejudgment attachment or seizure) of material assets; 

10.5.6 any entry into any restructuring agreement or workout agreement, or similar agreement, relating to any material indebtedness; and 

10.5.7 loss of any permits, licences or governmental authorisations that are necessary for it to engage in its current business. 

10.6 EXCEPT AS EXPRESSLY SET OUT IN THIS AGREEMENT, EACH PARTY EXPRESSLY DISCLAIMS AND EXCLUDES ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PURPOSE OR ANY WARRANTY THAT THE PHASE III MC TRIAL OR THE PERFORMANCE OF THE COLLABORATION PROGRAMME WILL PRODUCE ANY PARTICULAR RESULT.