Master Alliance Provisions Guide (MAPGuide)

MSD – MPP, Molnupiravir License Agreement

  • Liability | Representations & Warranties

MSD-MPP Agreement

5. Representations, Warranties, And Covenants

5.1 Ability to Perform. MPP and MSD 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) 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.
(d) that it shall not and will not employ or otherwise use in any capacity the services of any person or entity debarred under 21 U.S.C. § 335a (or equivalent foreign provisions) in performing any activities under this Agreement. Each Party shall notify the other Party, in writing, immediately if any such debarment occurs or comes to its attention, and shall, with respect to any person or entity so debarred, promptly remove such person or entity from performing any further activities under this Agreement, as applicable.

5.2 MSD represents and warrants that:

(a) It owns the entire right, title, and interest in, or otherwise has the right to grant the licenses and rights granted to MPP herein within the scope of the Patents as set forth in Exhibit A hereto and the MSD Know-How, and MSD and its Affiliates have not, and shall not, grant any rights that conflict with such licenses and rights or that would otherwise prevent MPP from exercising its rights or performing its obligations hereunder;
(b) As of the Effective Date and to the extent the Patents have been granted, MSD has no knowledge of any pending or threatened opposition, interference, or litigation proceedings;
(c) MSD has not, nor to its knowledge, has any Third Party acting under authority of MSD, made an untrue statement of a material fact to any regulatory authority in the Territory with respect to any Product, or knowingly failed to disclose a material fact required to be disclosed to any regulatory authority in the Territory with respect to any Product. MSD has, and to its knowledge such Third Parties have, complied and shall comply with all regulatory requirements with respect to the Substance and Product.

5.3 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 any US, EU, Swiss, or other anti-competition, sanctions and export control laws and regulations that may apply. MPP further agrees that it shall not export, re-export, transfer, transmit, or release (including to a foreign national within the United States and Germany) any goods, materials, software, or technology (including technical data) without first obtaining all necessary authorizations from the relevant government agencies. Notwithstanding anything herein to the contrary, any delay or failure to perform any part of this Agreement by either Party resulting from a denial, delay, or withdrawal of any required export authorization shall not constitute a breach of this Agreement nor expose either Party to liability hereunder.

(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.

5.4 DISCLAIMER: EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, MSD MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE PATENTS OR ANY LICENSE GRANTED BY MSD HEREUNDER, OR WITH RESPECT TO THE SUBSTANCE OR THE PRODUCTS, OR ANY OTHER MATTER. FURTHERMORE, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE PATENTS IS VALID OR ENFORCEABLE OR THAT THE MPP’S OR SUBLICENSEE(S)’S USE OF THE PATENTS, SUBSTANCE OR PRODUCT AS CONTEMPLATED HEREUNDER WILL NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. MSD ALSO DOES NOT GIVE ANY WARRANTY, EXPRESS OR IMPLIED, WITH REGARD TO THE SAFETY OR EFFICACY OF THE SUBSTANCE OR THE PRODUCT AND IT SHALL BE THE SOLE RESPONSIBILITY OF THE SUBLICENSEES TO ENSURE SUCH SAFETY OR EFFICACY.

Form of Sublicense Agreement

6. Representations, Warranties, And Covenants

6.1 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, and 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.
(d) it has not and will not employ or otherwise use in any capacity the services of any person or entity debarred under 21 U.S.C. 335a (or equivalent foreign provisions) in performing any activities under this Agreement. Each Party shall notify the other Party, in writing, immediately if any such debarment occurs or comes to its attention, and shall, with respect to any person or entity so debarred, promptly remove such person or entity from performing any further activities under this Agreement, as applicable.
(e) shall comply with all applicable laws, regulations and codes relating to data privacy, personal data, trans-border data flow, and data protection involved in handling any personal data and information related to each other and their representatives. It shall be the duty of MPP and the Licensee to ensure that no personally identifiable information that permits the identity of an individual to whom the information applies to be reasonably inferred by either direct or indirect means is shared with each other under any circumstances without complying with applicable privacy laws. This obligation shall survive the expiry of this Agreement.

6.2 Law and 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 anti-competition, recalls, safety and reporting requirements and export controls and sanctions, and shall obtain, have and maintain all necessary regulatory approvals, marketing authorizations, export licenses, and other permits and licenses, at Licensee’s expense for the manufacture and sale of the Substance and/or Product and any other Licensee activities contemplated hereby. Licensee further agrees that it shall not export, reexport, transfer, transmit, or release (including to a foreign national within the United States and Germany) any goods, materials, software, or technology (including technical data) without first obtaining all necessary authorizations from the relevant government agencies. Notwithstanding anything herein to the contrary, any delay or failure to perform any part of this Agreement by either Party resulting from a denial, delay, or withdrawal of any required export authorization shall not constitute a breach of this Agreement nor expose either Party to liability hereunder.

(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.

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6.5 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, MPP AND MSD (IN THE MPP-MSD AGREEMENT) MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE PATENTS OR ANY LICENSE GRANTED BY MPP AND MSD (IN THE MPP-MSD AGREEMENT) HEREUNDER, OR WITH RESPECT TO THE SUBSTANCE OR THE PRODUCTS, OR ANY OTHER MATTER. FURTHERMORE, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE PATENTS IS VALID OR ENFORCEABLE OR THAT THE MPP’S OR LICENSEE(S)’S USE OF THE PATENTS, SUBSTANCE OR PRODUCT AS CONTEMPLATED HEREUNDER WILL NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. MPP AND MSD (IN THE MPP-MSD AGREEMENT) ALSO DOES NOT GIVE ANY WARRANTY, EXPRESS OR IMPLIED, WITH REGARD TO THE SAFETY OR EFFICACY OF THE SUBSTANCE OR THE PRODUCT AND IT SHALL BE THE SOLE RESPONSIBILITY OF THE LICENSEE TO ENSURE SUCH SAFETY OR EFFICACY.