Common use of Pfizer Covenants Clause in Contracts

Pfizer Covenants. In addition to the covenants made by Pfizer elsewhere in this Agreement, Pfizer hereby covenants to BioNTech that, from the Execution Date until expiration or termination of this Agreement, 9.6.1. Pfizer and its Affiliates maintain or will obtain valid and enforceable agreements with or from all inventors of Pfizer Improvements, Research Program Technology, RNA Improvements or Reversion Technology who are employed by or otherwise acting on behalf of Pfizer or its Affiliates valid and enforceable agreements assigning to Pfizer or its Affiliates each such inventor’s entire right, title and interest in and to all such Pfizer Improvements, Research Program Technology or RNA Improvements (except to the extent applicable Law provides that all right, title and interest in and to such Pfizer Improvements, Research Program Technology or RNA Improvements automatically vests in Pfizer or its Affiliates by operation of law), and Pfizer and its Affiliates have made or will make any payments owing to any such inventors in respect of any Pfizer Improvements, Research Program Technology or RNA Improvements or any other Person that is required in connection with the creation or exploitation of or transfer of rights to such Pfizer Improvements, Research Program Technology or RNA Improvements; 9.6.2. with respect to Human Material used, including collection or transfer, by Pfizer, its Affiliates or permitted subcontractors in conducting activities under this Agreement, (a) such use shall be within the scope of and consistent with its ethical approval policies, (b) Pfizer will, and will cause its Affiliates or permitted subcontractors to, handle and use the Human Material in accordance with all applicable Laws and the ICF, (c) Pfizer will provide the ICF to BioNTech upon request by BioNTech, (d) the Human Material will be used for research purposes only and not be used for treatment of or administration to humans and (e) if Pfizer procures any Human Material from a Third Party such as a sample bank, it will ensure that the collection and transfer of the Human Material and the use of the Human Material for purposes of the Research Plan is in accordance with all applicable Laws and recognized international standards for the protection of human research subjects; and 9.6.3. Pfizer will comply with the provisions of the Current Licenses set forth in Schedule 9.6.3 in respect of BioNTech Technology sublicensed to Pfizer under the respective Current Licenses insofar as Pfizer is using such BioNTech Technology.

Pfizer Covenants. In addition to the covenants made by Pfizer elsewhere in this Agreement, Pfizer hereby covenants to BioNTech that, from the Execution Effective Date until expiration or termination of this Agreement, 9.6.112.6.1. Pfizer and its Affiliates maintain or will obtain valid and enforceable agreements with or from all inventors of Pfizer Improvements, Research Program Technology, RNA Improvements or Reversion Research and Development Program Technology who are employed by or otherwise acting on behalf of Pfizer or its Affiliates valid and enforceable agreements assigning to Pfizer or its Affiliates each such inventor’s entire right, title and interest in and to all such Pfizer Improvements, Improvements or Research and Development Program Technology or RNA Improvements (except to the extent applicable Law provides that all right, title and interest in and to such Pfizer Improvements, Improvements or Research and Development Program Technology or RNA Improvements automatically vests in Pfizer or its Affiliates by operation of law), and Pfizer and its Affiliates have made or will make any payments owing to any such inventors in respect of any Pfizer Improvements, Improvements or Research and Development Program Technology or RNA Improvements or any other Person that is required in connection with the creation or exploitation of or transfer of rights to such Pfizer Improvements, Improvements or Research and Development Program Technology or RNA ImprovementsTechnology; 9.6.212.6.2. with respect to Human Material used, including collection or transfer, by Pfizer, its Affiliates or permitted subcontractors in conducting activities under this Agreement, (a) such use shall be within the scope of and consistent with its ethical approval policies, (b) Pfizer will, and will cause its Affiliates or permitted subcontractors to, handle and use the Human Material in accordance with all applicable Laws and the ICF, (c) Pfizer will provide the ICF to BioNTech upon request by BioNTech, (d) the Human Material will be used for research purposes only and not be used for treatment of or administration to humans and (e) if Pfizer procures any Human Material from a Third Party such as a sample bank, it will ensure that the collection and transfer of the Human Material and the use of the Human Material for purposes of the Research and Development Plan is in accordance with all applicable Laws and recognized international standards for the protection of human research subjects; and 9.6.312.6.3. Pfizer will comply with the provisions of the Current Licenses set forth in Schedule 9.6.3 1.36 in respect of BioNTech Technology sublicensed to Pfizer under the respective Current Licenses insofar as Pfizer is using such BioNTech Technology; 12.6.4. Pfizer shall comply with its Anti-Bribery and Anti-Corruption Principles attached hereto as Exhibit B and its Corporate Policy regarding Animal Care and Use, attached hereto as Exhibit C; and 12.6.5. in it undertaking, sponsoring, or having regulatory oversight over any Clinical Trials, Pfizer shall ensure and procure that all documentation for such Clinical Trials shall comply with, and take advantage of, any applicable Laws that serve to limit product liability claims and losses having regard to the pandemic status of COVID-19, including any requirements under any declarations pursuant to the Public Readiness and Emergency Preparedness (PREP) Act in the USA or any equivalent, similar or comparable legislation in the Territory.

Pfizer Covenants. In addition to the covenants made by Pfizer elsewhere in this Agreement, Pfizer hereby covenants to BioNTech that, from the Execution Effective Date until expiration or termination of this Agreement, 9.6.1. 13.6.1 In connection with its activities under this Agreement, Pfizer will, at all times during the term of this Agreement, maintain its licenses, consents, authorizations or registrations to do business and continue to make any notifications as may be necessary or required by local Laws, regulations, policies, or administrative requirements in order to provide the Products or Services encompassed within this Agreement, and will ensure that providing such Products or Services will not be inconsistent with any other obligation of Pfizer; 13.6.2 Pfizer and its Affiliates maintain or will obtain valid and enforceable agreements with or from all inventors of Pfizer Improvements, Research Program Technology, RNA Improvements or Reversion Research and Development Program Technology who are employed by or otherwise acting on behalf of Pfizer or its Affiliates valid and enforceable agreements assigning to Pfizer or its Affiliates each such inventor’s entire right, title and interest in and to all such Pfizer Improvements, Improvements or Research and Development Program Technology or RNA Improvements (except to the extent applicable Law provides that all right, title and interest in and to such Pfizer Improvements, Improvements or Research and Development Program Technology or RNA Improvements automatically vests in Pfizer or its Affiliates by operation of law), and Pfizer and its Affiliates have made or will make any payments owing to any such inventors in respect of any Pfizer Improvements, Improvements or Research and Development Program Technology or RNA Improvements or any other Person that is required in connection with the creation or exploitation of or transfer of rights to such Pfizer Improvements, Improvements or Research and Development Program Technology or RNA ImprovementsTechnology; 9.6.2. 13.6.3 with respect to Human Material used, including collection or transfer, by Pfizer, its Affiliates or permitted subcontractors in conducting activities under this Agreement, (a) such use shall be within the scope of and consistent with its ethical approval policies, (b) Pfizer will, and will cause its Affiliates or permitted subcontractors to, handle and use the Human Material in accordance with all applicable Laws and the ICF, (c) Pfizer will provide the ICF to BioNTech upon request by BioNTech, (d) the Human Material will be used for research purposes only and not be used for treatment of or administration to humans and (e) if Pfizer procures any Human Material from a Third Party such as a sample bank, it will ensure that the collection and transfer of the Human Material and the use of the Human Material for purposes of the Research and Development Plan is in accordance with all applicable Laws and recognized international standards for the protection of human research subjects; and 9.6.3. 13.6.4 Pfizer will comply with the provisions of the Current Licenses set forth in Schedule 9.6.3 1.45 in respect of BioNTech Technology sublicensed to Pfizer under the respective Current Licenses insofar as Pfizer is using such BioNTech Technology; 13.6.5 Pfizer shall comply with its Anti-Bribery and Anti-Corruption Principles attached hereto as Exhibit B and its Corporate Policy regarding Animal Care and Use, attached hereto as Exhibit C; and 13.6.6 in it undertaking, sponsoring, or having regulatory oversight over any Clinical Trials, Pfizer shall ensure and procure that all documentation for such Clinical Trials shall comply with, and take advantage of, any applicable Laws that serve to limit product liability claims and losses having regard to the pandemic status of COVID-19, including any requirements under any declarations pursuant to the Public Readiness and Emergency Preparedness (PREP) Act in the USA or any equivalent, similar or comparable legislation in the Territory. 13.6.7 In connection with its activities under this Agreement, Pfizer agrees to comply with all applicable Laws, including all applicable Anti-Corruption Laws; and Pfizer has not taken, and will not during the term of this Agreement, take any action directly or indirectly to (i) offer, promise, provide, or authorize the offer or provision of money or anything of value, in order to improperly or corruptly seek to influence any Government Official or any other person in order to obtain or retain business or any other improper business advantage; (ii) request or accept any such improper payment; or (iii) cause a violation of any applicable Anti-Corruption Law. For example, this includes providing any inducement for such Government Official or person to approve, reimburse, prescribe, or purchase a Product, to influence the outcome of a clinical trial, or otherwise to benefit Pfizer’s business activities improperly; 13.6.8 Pfizer agrees, at all times during the term of this Agreement, to: (i) maintain truthful and complete documentation supporting, in reasonable detail, the work and services performed and any expenses incurred in connection with this Agreement; and (ii) maintain financial books and records that timely, fairly, accurately, and completely reflect all financial transactions, in accordance with all applicable Laws, including applicable Anti-Corruption Laws (for example, invoices, reports, statements, books, and other records), and shall maintain such books and records during the term of this Agreement and for five years after final payment has been made under this Agreement; 13.6.9 In connection with any audit or any investigation regarding any potential violations of applicable Laws related to this Agreement, including all applicable Anti-Corruption Laws, Pfizer agrees to permit, during the term of this Agreement and for five years after final payment has been made under this Agreement, BioNTech’s external auditors access to any non-privileged relevant books, documents, papers, and records of Pfizer involving transactions related to the Products, payments, or services provided under this Agreement; and 13.6.10 Pfizer agrees, from the beginning of the Commercialization Activities onwards until the end of the Term, to maintain and enforce adequate policies and procedures describing the materials and information that may be distributed or discussed by Pfizer’s employees, contractors, subcontractors, or agents related to the Products, and the manner in which such persons should handle unsolicited requests for information related to off-label uses of the Products. Such policies and procedures should be designed to ensure compliance with applicable Laws and regulations;