Master Alliance Provisions Guide (MAPGuide)

AbbVie – MPP, HIV Antiretroviral (lopinavir, ritonavir – LPV/r) Pediatric License Agreement

  • Liability | Representations & warranties

AbbVie – MPP Agreement

4. MPP Obligations

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4.5 OFAC. MPP represents that neither MPP nor, to the knowledge of MPP, any director, officer, employee, or agent of MPP, is an individual or entity (“Person”) that is, or is owned or controlled by Persons that are: (i) the target of any sanctions administered or enforced by the U.S. Department of the Treasury’s Office of Foreign Assets Control (“Sanctions”), or (ii) located, organized or resident in a country or territory that is, or whose government is, the target of Sanctions (including, without limitation, Cuba, Iran, North Korea, Sudan, and Syria) MPP represents and covenants that it will not, directly or indirectly, use, transfer, lend, contribute or otherwise make available AbbVie Patents to any Person to engage in any activities or business of or with any Person, or in any country or territory, that, at the time of such transfer or other transaction, is, or whose government is, the target of Sanctions unless exempt from, or authorized pursuant to, applicable Sanctions

6. Representations, Warranties and Covenants

6.1 Ability to Perform. MPP and AbbVie each represent and warrant that:

(a) it is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

(b) this Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; and

(c) the execution, delivery and performance of this 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 is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such party.

6.2 MPP Representations. MPP represents, warrants and covenants that:

(a) all of its activities related to the use of the AbbVie Patents and Licensed Product by the Sublicensees, pursuant to this Agreement and the Sublicense Agreements will comply with all applicable legal and regulatory requirements; and

(b) as between AbbVie and MPP and between AbbVie and any Sublicensee, MPP acknowledges and agrees that AbbVie will have no liability whatsoever in relation to any infringement of the intellectual property rights of any Third Party by either MPP or any Sublicensee.

6.3 Law Compliance

(a) General. MPP covenants and agrees that it shall perform all activities under this Agreement in accordance 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) and, in particular, MPP 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. MPP will certify to AbbVie in writing, at the frequency requested by AbbVie (and at least once annually), compliance with their obligations under this Agreement (including compliance with the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010).

(b) Conflicts. Neither party shall be required to take any action or perform any obligation under this Agreement to the extent that such action or obligation is in direct conflict with any applicable law, rule or regulation.

6.4 NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, MPP ACKNOWLEDGES AND AGREES THAT (I) THE ABBVIE PATENTS ARE LICENSED TO MPP “AS IS” AND (II) ABBVIE DOES NOT GIVE ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE LICENSED PRODUCTS, THE ABBVIE PATENTS OR ANY OTHER MATTER, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT.

Form of Sublicense

7. Representations, Warranties and Covenants

7.1 Ability to Perform. Each of the parties hereby represents and warrants that:

(a) it is duly organized, validly existing and in good standing under the laws of the jurisdiction of their incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

(b) this Agreement has been duly executed and delivered, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; and

(c) the execution, delivery and performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such party.

7.2 Law Compliance

(a) General. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws and regulations, including, without limitation, with respect to (i) recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals (including in India), marketing authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of the Licensed Compound or Licensed Product and any other Licensee activities contemplated hereby, and (ii) all applicable anti-bribery and corruption laws (including the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010) and, in particular, Licensee 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. Licensee will certify to Licensor in writing, at the frequency requested by Licensor (and at least once annually), compliance with their obligations under this Agreement (including compliance with the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010).

(b) Conflicts. None of the parties shall be required to take any action or perform any obligation under this Agreement to the extent that such action or obligation is in direct conflict with any applicable law, rule or regulation.

7.3 OFAC. The Licensee represents that neither the Licensee nor, to the knowledge of the Licensee, any director, officer, employee of the Licensee, is an individual or entity (“Person”) that is, or is owned or controlled by Persons that are the target of any sanctions administered or enforced by the U.S. Department of the Treasury’s Office of Foreign Assets Control (“Sanctions”) or located, organized or resident in a country or territory that is the target of country-wide or territory-wide Sanctions (collectively, “Sanctions Target”). The Licensee represents and covenants that, prior to making the Patents or any Licensed Product available, directly or indirectly, to any Person that is a Sanctions Target, it will obtain a license or other authorization, either directly or through Licensor, from OFAC.

7.4 NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, LICENSEE ACKNOWLEDGES AND AGREES THAT (I) THE ABBVIE PATENTS ARE LICENSED TO LICENSEE “AS IS” AND (II) NEITHER LICENSOR NOR ABBVIE MAKE ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE LICENSED COMPOUNDS, LICENSED PRODUCTS, ABBVIE PATENTS OR ANY OTHER MATTER UNDER THIS AGREEMENT INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT. IN PARTICULAR, AND WITHOUT LIMITING THE FOREGOING, ABBVIE WILL HAVE NO LIABILITY IN THE EVENT THE EXERCISE BY LICENSEE OF ITS RIGHTS UNDER THIS AGREEMENT INFRINGES THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. Licensor also does not give any warranty, express or implied, with regard to the safety or efficacy of any Licensed Compound or Licensed Product and it shall be the sole responsibility of the Licensee to ensure such safety or efficacy.