Provision Language
3. LICENSE GRANT
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3.8 OFAC Licenses
(a) The Sublicensee represents that, to its knowledge, neither the Sublicensee nor any of its Affiliates, directors, officers, or employees, is a Sanctions Target.
(b) The Sublicensee agrees that it will not, with respect to the licensed intellectual property (including the Sublicensed Rights and Sublicensed Manufacturing KnowHow), Licensed Compound and Licensed Product, engage in any transactions or dealings with or involving a Sanctions Target or a country or territory that is the target of US or EU country-wide or territory-wide Sanctions absent a license or other authorization from the relevant governmental authority, should such a license or other authorization be required. The Sublicensee shall convey such license or other authorization to GARDP and Shionogi, if required and obtained, prior to any such transactions or dealings.
The Sublicensee also agrees that prior to, directly or indirectly,
(a) making any Licensed Compound or any Licensed Product available to, or contracting for Licensed Product Manufacture with, any Sanctions Target; or
(b) making any Licensed Compound or any Licensed Product available to, or contracting for Licensed Product Manufacture in, a country or territory that is the target of country-wide or territory-wide Sanctions;
it will obtain a license or other authorization, if required, either directly from the relevant government authority or cooperate with GARDP and Shionogi to obtain such a license or other authorization in each case to permit the Sublicensee, GARDP and Shionogi (as the ultimate licensor of the Licensed Product) to engage in transactions with a Sanctions Target or involving a country or territory that is the target of countrywide or territory-wide Sanctions. If Shionogi and GARDP are in agreement with the decision to try to obtain such license or other authorization (such decision to be made in their sole discretion), GARDP shall, and shall in accordance with the Shionogi License Agreement request that Shionogi provide, reasonable assistance as requested by the Sublicensee and as may be reasonably necessary to obtain the license or other authorization; and in the event that performance of this Sublicense Agreement by the Sublicensee would (or might), in the reasonable opinion of GARDP or Shionogi, breach, or expose GARDP or Shionogi to potential liability under, any Sanctions or export control regime or any other similar laws of any jurisdiction (whether or not such Sanctions, controls or laws were in existence at the date of this Sublicense Agreement, and whether or not there have been any other changes in circumstance from those that existed at the Effective Date of this Sublicense Agreement), GARDP or Shionogi shall be entitled to immediately request that the Sublicensee (i) cease all shipments of Licensed Compound or Licensed Product into any country or territory that is the target of countrywide or territory-wide Sanctions, or (ii) if the Licensed Compound or Licensed Product is already in such country or territory but still within the custody and control of the Sublicensee or its respective agents or representatives, to use its reasonable best efforts to remove such Licensed Compound or Licensed Product from the country or territory, or (iii) suspend the operation of such provisions of the Sublicense Agreement (including any supply provisions) which require or permit performance by either Party or Shionogi which, in the reasonable opinion of Shionogi or GARDP, would result in a breach of, or expose Shionogi or GARDP to potential liability under, any such Sanctions, controls, or laws, until, in the reasonable discretion of Shionogi or GARDP, as applicable, until such time as all necessary approvals or licenses have been obtained to enable the Sublicense Agreement to continue in a lawful and compliant manner and without exposure to liability for Shionogi or GARDP. Notwithstanding any provision of the Sublicense Agreement, neither Shionogi nor GARDP shall be obliged to pay any compensation to the Sublicensee or otherwise indemnify them in respect of any losses or costs which they may suffer or incur as a result of such suspension and/or termination.
7. REPRESENTATIONS AND WARRANTIES
7.1 General. Each Party hereby represents, covenants and warrants to the other that:
(a) it is duly organized and validly existing under the applicable law of the jurisdiction of its incorporation, and has full corporate power and authority to enter into this Sublicense Agreement and to carry out the provisions hereof;
(b) it is qualified to do business and is in good standing in each jurisdiction in which it conducts business;
(c) it is duly authorized to execute and deliver this Sublicense Agreement and to perform its obligations hereunder, and the Person executing this Sublicense Agreement on its behalf has been duly authorized to do so by all requisite corporate or institutional action;
(d) this Sublicense Agreement is legally binding upon it and enforceable in accordance with its terms and the execution, delivery and performance of this Sublicense 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;
(e) the performance of this Sublicense Agreement by either Party does not create a breach or default under any other agreement to which it is a party; and
(f) it will comply with all applicable laws and regulations, including all applicable antibribery and corruption laws (including the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010).
7.2 Representations, warranties and covenants of the Sublicensee. The Sublicensee warrants and covenants to GARDP and Shionogi that:
(a) it has the capability and intent to manufacture the Licensed Compound and Licensed Product to ensure affordable and sustainable access to quality Licensed Products through this Sublicense Agreement, and will use reasonable best efforts to seek, obtain and thereafter maintain continuously in good standing all Manufacturing Approvals required for such manufacture and related activities;
(b) 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; and the Sublicensee will certify to GARDP, at the frequency requested by GARDP (and at least once annually), its compliance with its obligations under this Sublicense Agreement (including compliance with the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010);
(c) all of its activities related to the use of the Sublicensed Rights and Sublicensed Manufacturing Know-How and the Development and Manufacture of the Licensed Compound and of the Licensed Product pursuant to this Sublicense Agreement will comply with all applicable legal and regulatory requirements;
(d) it will, during the Term, perform regular internal due diligence to ensure ongoing compliance with all applicable laws and the terms of this Sublicense Agreement; and
(e) it will not engage in any activities that use the Sublicensed Rights and/or Sublicensed Manufactured Know-How in a manner that is outside the scope of the license rights granted to it under this Sublicense Agreement and that any modifications to the manufacturing process or compound technology will be undertaken at the Sublicensee’s sole risk and in no event will Shionogi or GARDP indemnify, hold harmless or defend Sublicensee for any such modifications.
7.3 “AS IS” license
(a) Notwithstanding any other provision of this Sublicense Agreement, the Sublicensee acknowledges and agrees that the Sublicensed Rights and Sublicensed Manufacturing Know-How are licensed to the Sublicensee “as is”.
(b) The Sublicensee acknowledges and agrees that neither Shionogi nor any of its Affiliates nor GARDP will have any 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 Compound and/or Licensed Product by the Sublicensee.
(c) Notwithstanding any other provision of this Sublicense Agreement, neither GARDP nor Shionogi nor any of its Affiliates makes any representation or warranty of noninfringement or any representation or warranty that the Sublicensed Rights or Sublicensed Manufacturing Know-How is suitable for any purpose for which it may be used by the Sublicensee.
(d) The Sublicensee acknowledges that Shionogi, its Affiliates and GARDP have made no representations or warranties to the Sublicensee regarding the Sublicensed Rights or the Licensed Product, and that the Sublicensee has independently evaluated any information supplied by or on behalf of Shionogi, its Affiliates and GARDP before making its decision to enter into the Sublicense Agreement and undertake the commitments and obligations set forth herein.
7.4 Disclaimer
(a) Shionogi and its Affiliates makes no, and except for Section 7.1 GARDP 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 Sublicensed Rights or Sublicensed Manufacturing Know-How or any license granted by GARDP under this Sublicense Agreement, or with respect to any compounds or products.
(B) FURTHERMORE, NOTHING IN THIS SUBLICENSE AGREEMENT WILL BE CONSTRUED AS A REPRESENTATION OR WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE SUBLICENSED RIGHTS ARE VALID OR ENFORCEABLE OR THAT THE SUBLICENSEE’S USE OF THE SUBLICENSED RIGHTS AND SUBLICENSED MANUFACTURING KNOW-HOW CONTEMPLATED UNDER THIS SUBLICENSE AGREEMENT DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.
7.5 Additional Waiver. THE SUBLICENSEE AGREES THAT: (A) THE SUBLICENSED RIGHTS ARE LICENSED “AS IS”, “WITH ALL FAULTS”, AND “WITH ALL DEFECTS”, AND THE SUBLICENSEE EXPRESSLY WAIVES ALL RIGHTS TO MAKE ANY CLAIM WHATSOEVER AGAINST SHIONOGI OR GARDP FOR MISREPRESENTATION OR FOR BREACH OF PROMISE, GUARANTEE OR WARRANTY OF ANY KIND RELATING TO THE SUBLICENSED RIGHTS; (B) THE SUBLICENSEE AGREES THAT SHIONOGI AND GARDP WILL HAVE NO LIABILITY TO THE SUBLICENSEE FOR ANY ACT OR OMISSION IN THE PREPARATION, FILING, PROSECUTION, MAINTENANCE, ENFORCEMENT, DEFENSE OR OTHER HANDLING OF THE SUBLICENSED RIGHTS; AND (C) THE SUBLICENSEE IS SOLELY RESPONSIBLE FOR DETERMINING WHETHER THE SUBLICENSED RIGHTS HAVE APPLICABILITY OR UTILITY IN THE SUBLICENSEE’S CONTEMPLATED EXPLOITATION OF THE LICENSED PRODUCT, AND THE SUBLICENSEE ASSUMES ALL RISK AND LIABILITY IN CONNECTION WITH SUCH DETERMINATION.