Master Alliance Provisions Guide (MAPGuide)

Israel – Pfizer Real-World Epidemiological Evidence Collaboration Agreement

  • Liability | Representations & Warranties

7. Representations and Warranties

7.1 Each Party covenants, represents and warrants to the other Party that such Party have full right, power and authority to enter into this Agreement and there is nothing which will prevent it from performing its obligations under the terms and conditions of this Agreement; 

7.2 Each Party covenants, represents and warrants that it shall in its respective performance of this Agreement and the Project take all actions necessary and appropriate to assure that it complies with (a) the terms of this Agreement including any applicable Project plans and other attachments hereto, and (b) the Regulatory Requirements. Each Party warrants and undertakes that is has obtained all necessary regulatory approvals and permits required under law to transfer or receive the Project Data, and applicable, and there is no impediment under any law to execute this Agreement. MoH has determined that IRB or privacy board approvals are required for the Project.

7.3 Each Party covenants that all materials, work product and documentation created pursuant to this Agreement shall not infringe upon any patent, copyright or other intellectual property rights of any third party. 

7.4 Each Party covenants, represents and warrants to the other Party that such Party is not debarred by any applicable authority, including under subsections 306(a) or (b) of the federal Food, Drug, and Cosmetic Act, as amended, is not on the U.S. Government Suspension and Debarment List; HHS OIG Excluded Parties List; or any similar disqualification lists, licensure restrictions, disciplinary sanctions, or enforcement action against scientists, health care providers, or research professionals under the laws of Israel, the U.S. or any other jurisdiction and it has not and shall not use in any capacity the services of any person or entity, including any individuals, agents, employees, subcontractors, customers, healthcare providers, hospitals, pharmacies, clinics and any other relevant party that is involved, directly or indirectly, in the activities under this Agreement, that has been debarred by any such applicable authority with respect to this Agreement. Such Party shall immediately notify the other Parties in the event that it, its subcontractors or any of its or their employees becomes debarred or excluded during the Term of this Agreement. Such Party acknowledges that such debarment shall be grounds for termination of this Agreement by the other Parties for cause. 

7.5 Each Party represents and warrant that the services performed under this Agreement do not and will not involve the counseling or promotions of a business arrangement or other activity that violates applicable law. Each Party further represent and warrants that it has not and will not in the future directly or indirectly offer or pay, or authorize the offer or payment or any money or anything or value in an effort to influence any government official or any other person in order for Pfizer to improperly obtain or retain business or to gain an improper business advantage, and, has not accepted, and will not accept in the future, such payment. Each Party further represents and warrants that MOH has been provided with a copy of Pfizer’s Anti-Bribery and Anti-Corruption Principles (attached hereto as Exhibit C) and will communicate such principles to all persons acting on its behalf in connection with the Project, including agents or subcontractors. For the avoidance of doubt, nothing in this agreement shall be construed to (a) obligate MoH to grant regulatory approval, promote, prescribe, purchase, order or recommend, or arrange for the promotion, prescription, purchase, order or recommendation of any product manufactured and/or marked by PFIZER, or (b) oblige MoH to place any products manufactured and/or marketed by PFIZER on MoH’s formularies (e.g., formularies MoH operates or maintains on behalf of itself) or third parties (such as sick funds) formularies.

7.6 Each Party represents and warrants the services and any transfers of value provided by the respective Party, are in no way based upon the value or volume of purchases or business between the Parties.

7.7 Compliance with Global Trade Controls: The activities covered by this Agreement may be subject to Global Trade Control Laws. Parties will perform their respective obligations under this Agreement in full compliance with all applicable Global Trade Control Laws.

7.7.1 Each Party represents and warrants that such Party and its respective owners, directors, and officers are neither a Restricted Party, nor owned or controlled by a Restricted Party. With respect to the activities performed under this Agreement, each Party confirms that Affiliates, agents, employees, or subcontractors directly or indirectly involved in the activities contemplated under this Agreement are not Restricted Parties and that no such Restricted Parties will be engaged in any activities contemplated under this Agreement or delegated any activities contemplated under this Agreement. In the event that any of these representations change during the Term of this Agreement, the Party connected with such a person or entity will immediately inform the other Party and suspend all related activities and payments under this Agreement until the Parties agree to move forward.

Notwithstanding any cure periods set forth herein, the Parties acknowledge that designation as a Restricted Party shall be grounds for immediate termination of this Agreement, in whole or in relevant part, by the other Party, for cause, with no cure period.

7.7.2 Parties must include this and all Global Trade Control Laws provided above, as well as related definitions, in any contract or agreement necessary to perform, or related to the performance of the discount arrangement under this Agreement.

7.8 PFIZER shall not use the Project Data for any purpose and in any manner which does not serve to improve healthcare, public health, or is discriminatory in respect of insurance or employment or has an otherwise inappropriate social purpose, and (ii) perform or enable to perform in any way, any activity that may result in exposing the identity or identifying data of individual patients, in relation to the Project Data, including de-anonymizing or (re)identifying the Project Data in any way.

7.9 The MoH warrants, represents and covenants that it has obtained all necessary regulatory approvals and permits required under law to transfer and grant the license to the Project Data.