Master Alliance Provisions Guide (MAPGuide)

Shionogi – GARDP, Cefiderocol License Agreement

  • Liability | Representations & Warranties

7. REPRESENTATIONS AND WARRANTIES

7.1 General 

Each Party hereby represents, covenants, and warrants to the other that: 

(i) it is duly organized and validly existing under the applicable law of the jurisdiction of its incorporation or organization, and has full corporate or institutional power and authority to enter into this License Agreement and to carry out the provisions hereof;

(ii) it is qualified to do business and is in good standing in each jurisdiction in which it conducts business; 

(iii) it is duly authorized to execute and deliver this License Agreement and to perform its obligations hereunder, and the Person executing this License Agreement on its behalf has been duly authorized to do so by all requisite corporate or institutional action; and 

(iv) this License Agreement is legally binding upon it and enforceable in accordance with its terms and the execution, delivery, and performance of this License Agreement by such Party does not conflict with any agreement, instrument, or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material applicable law; 

(v) the performance of this License Agreement by either Party does not create a breach or default under any other agreement to which it is a party; and 

(vi) it will comply with all applicable laws and regulations, including all applicable anti-bribery and corruption laws (including the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010, as applicable). 

7.2 Representations and warranties of Shionogi 

Shionogi represents and warrants to GARDP that, with respect to the Licensed Compound: 

(i) Shionogi owns or otherwise Controls the Licensed Rights (including the Licensed Manufacturing Know-How) and the Licensed Compound described in Schedule A, free and clear of any liens, charges and encumbrances, and has the right to grant to GARDP the license to the Licensed Rights granted hereunder; and 

(ii) as of the Effective Date, Shionogi has not received written notification of, any claim pending, threatened, or previously made, alleging that the use or practice of the Licensed Rights (including the Licensed Manufacturing Know-How) or the Manufacture, use or Commercialization of the Licensed Compound or Licensed Product infringes or misappropriates any patent, trade secret, or other intellectual property right of any Third Party.

7.3 Representations, warranties and covenants of GARDP 

GARDP represents, warrants, and covenants to Shionogi that: 

(i) Sublicensees will be selected in accordance with the Collaboration Agreement and the Market Access Plan; 

(ii) it will have and maintain suitable mechanisms in order to comply with all applicable laws (including the U.S. Foreign Corrupt Practices Act and the UK Bribery Act), in particular, it will not, directly or indirectly, offer, promise, or give any financial or other advantage and/or pay money or anything of value to government officials, political parties, candidates, and any other person for the purposes of corruptly obtaining or retaining business; each Party will certify to the other in writing, at the frequency requested by the other Party (and at least once annually), compliance with its obligations under this License Agreement (including compliance with the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010); 

(iii) it will, during the Term, perform regular internal due diligence to ensure ongoing compliance with all applicable laws and the terms of this License Agreement and its compliance under all Sublicense Agreements; 

(iv) all of its activities related to the use of the Licensed Rights and Licensed Manufacturing Know-How and the Development and Commercialization of the Licensed Compound and Licensed Product by its Sublicensees pursuant to this License Agreement and the Sublicense Agreements will comply with all applicable legal and regulatory requirements;

(v) it will not engage in any activities that use the Licensed Rights and/or Licensed Manufactured Know-How in a manner that is outside the scope of the license rights granted to it under this License Agreement; 

(vi) any modifications to the Manufacturing process or compound technology will be undertaken at the Sublicensees’ sole risk and in no event will Shionogi indemnify, hold harmless, or defend GARDP or any Sublicensees for any consequences of such modifications; and 

(vii) as between Shionogi and the GARDP, and between Shionogi and any Sublicensees, GARDP acknowledges and agrees that Shionogi will have no liability whatsoever in relation to any infringement of the intellectual property rights of any Third Party arising out of the Development, Manufacture, and Commercialization of the Licensed Product by the Sublicensees, subject to Section 7.2. 

7.4 “AS IS” license 

(i) Notwithstanding any other provision of this License Agreement but subject to Sections 7.1 and 7.2, GARDP acknowledges and agrees that the Licensed Rights and Licensed Manufacturing Know-How are licensed to GARDP “as is”. 

(ii) Notwithstanding any other provision of this License Agreement but subject to Sections 7.1 and 7.2, Shionogi makes no representation or warranty of non-infringement or any representation or warranty that the Licensed Rights or Licensed Manufacturing Know-How is suitable for any purpose for which it may be used by GARDP or its Sublicensees.

7.5 Disclaimer 

Except for Sections 7.1 and 7.2, Shionogi makes no representations or warranties of any kind, either express or implied, including any express or implied warranties of merchantability or fitness for a particular purpose, with respect to the Licensed Rights or Licensed Manufacturing Know-How or any license granted by Shionogi under this License Agreement or any Sublicense Agreement, or with respect to any compounds or products. FURTHERMORE, NOTHING IN THIS LICENSE AGREEMENT OR THE SUBLICENSE AGREEMENT WILL BE CONSTRUED AS A REPRESENTATION OR WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE LICENSED RIGHTS ARE VALID OR ENFORCEABLE, OR SUBJECT TO SECTION 7.2 THAT GARDP’S OR ANY SUBLICENSEES’ USE OF THE LICENSED RIGHTS AND LICENSED MANUFACTURING KNOW-HOW CONTEMPLATED UNDER THIS LICENSE AGREEMENT OR ANY SUBLICENSE AGREEMENT DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

Schedule F: Provisions for Sublicense Agreement

3. Sublicensee Acknowledgement

Sublicensee hereby acknowledges that Licensor has made no representations or warranties to Sublicensee regarding the Licensed Rights or the Licensed Product, and that the Sublicensee has independently evaluated any information supplied by or on behalf of Licensor or Sublicensor before making its decision to enter into the Sublicense Agreement and undertake the commitments and obligations set forth herein.

20. Additional Waiver (Disclaimer of Warranty)

SUBLICENSEE AGREES THAT: (A) THE LICENSED RIGHTS ARE LICENSED “AS IS,” “WITH ALL FAULTS,” AND “WITH ALL DEFECTS,” AND SUBLICENSEE EXPRESSLY WAIVES ALL RIGHTS TO MAKE ANY CLAIM WHATSOEVER AGAINST LICENSOR OR SUBLICENSOR FOR MISREPRESENTATION OR FOR BREACH OF PROMISE, GUARANTEE OR WARRANTY OF ANY KIND RELATING TO THE LICENSED RIGHTS; (B) SUBLICENSEE AGREES THAT LICENSOR AND SUBLICENSOR WILL HAVE NO LIABILITY TO SUBLICENSEE FOR ANY ACT OR OMISSION IN THE PREPARATION, FILING, PROSECUTION, MAINTENANCE, ENFORCEMENT, DEFENSE OR OTHER HANDLING OF THE LICENSED RIGHTS; AND (C) SUBLICENSEE IS SOLELY RESPONSIBLE FOR DETERMINING WHETHER THE LICENSED RIGHTS HAVE APPLICABILITY OR UTILITY IN SUBLICENSEE’S CONTEMPLATED EXPLOITATION OF THE LICENSED PRODUCT, AND SUBLICENSEE ASSUMES ALL RISK AND LIABILITY IN CONNECTION WITH SUCH DETERMINATION.