Common use of Regulatory Communications and Filings Clause in Contracts

Regulatory Communications and Filings. Pfizer shall prepare, file in BioNTech’s name, diligently prosecute to grant, and maintain all applications for Regulatory Approvals (“Marketing Authorization Applications”) and all Regulatory Approvals obtained therefrom in respect of any Candidates or Products in USA and, subject to Section 9.2.1, the ROW. BionTech shall prepare, file in BioNTech’s name, diligently prosecute to grant, and maintain all applications for Marketing Authorization Applications and all Regulatory Approvals obtained therefrom in respect of any Candidates or Products in EU. The JSC may vary from the foregoing allocations by mutual consent. In accordance with Section 9.2.1, each Party shall cooperate with the other Party with respect to any and all regulatory matters for which the other Party is responsible pursuant to this Agreement or the Research and Development Plan. Unless exigent action is required with respect to a given filing before a Regulatory Authority concerning a Candidate or Product, or a material communication with a Regulatory Authority concerning the same, the Party submitting such Marketing Authorization Application shall provide the other Party with copies of all filings relating to such Marketing Authorization Application prior to submission within a reasonable amount of time (but not less than [***] Business Days) to allow such Party to review and comment on such filings, and the Party submitting such Marketing Authorization Application shall consider all comments and proposed revisions from the other Party in good faith prior to submission. The Party responsible for filing such Regulatory Approvals shall consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all Marketing Authorization Applications and the prosecution thereof, including any material communications that it receives with respect to the same. Upon request of the other Party, the Lead Development Party responsible for filing applications for such Regulatory Approvals shall provide to the other Party copies of all final Marketing Authorization Applications and filings relating thereto that it submits. The foregoing provisions of this Section 9.2.2 shall also apply to material and substantive communications with Regulatory Authorities.

Regulatory Communications and Filings. Pfizer shall prepare, file in BioNTech’s name, diligently prosecute to grant, and maintain all applications for Regulatory Approvals (“Marketing Authorization Applications”) and all Regulatory Approvals obtained therefrom in respect of any Candidates or Products in USA and, subject to Section 9.2.1, the ROW. BionTech shall prepare, file in BioNTech’s name, diligently prosecute to grant, and maintain all applications for Marketing Authorization Applications and all Regulatory Approvals obtained therefrom in respect of any Candidates or Products in EU. The JSC may vary from the foregoing allocations by mutual consent. In accordance with with Section 9.2.1, 9.2.1 each Party shall cooperate with the other Party with respect to any and all regulatory matters for which the other Party is responsible pursuant to this Agreement or the Research and Development Plan. Unless exigent action is required with respect to a given filing before a Regulatory Authority concerning a Candidate or Product, or a material communication with a Regulatory Authority concerning the same, the Party submitting such Marketing Authorization Application shall provide the other Party with copies of all filings relating to such Marketing Authorization Application prior to submission within a reasonable amount of time (but not less than [***] Business Days) to allow such Party to review and comment on such filings, and the Party submitting such Marketing Authorization Application shall consider all comments and proposed revisions from the other Party in good faith prior to submission. The Party responsible for filing such Regulatory Approvals shall consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all Marketing Authorization Applications and the prosecution thereof, including any material communications that it receives with respect to the same. Upon request of the other Party, the Lead Development Party responsible for filing applications for such Regulatory Approvals shall provide to the other Party copies of all final Marketing Authorization Applications and filings relating thereto that it submits. The foregoing provisions of this Section 9.2.2 shall also apply to material and substantive communications with Regulatory Authorities.

Regulatory Communications and Filings. Pfizer Amgen shall preparebe the regulatory lead outside the Territory and shall have responsibility for regulatory activities relating to the Licensed Products outside the Territory, file including preparing, submitting and maintaining all Regulatory Filings outside the Territory in BioNTech’s name, diligently prosecute to grantaccordance with the Development Plan, and maintain all applications Novartis shall provide strategic input for Regulatory Approvals (“Marketing Authorization Applications”) and all Regulatory Approvals obtained therefrom such activities therefor as set forth in respect of any Candidates or Products in USA and, subject to Section 9.2.1, the ROW. BionTech shall prepare, file in BioNTech’s name, diligently prosecute to grant, and maintain all applications for Marketing Authorization Applications and all Regulatory Approvals obtained therefrom in respect of any Candidates or Products in EU. The JSC may vary from the foregoing allocations by mutual consent. In accordance with Section 9.2.1, each Party shall cooperate with the other Party with respect to any and all regulatory matters for which the other Party is responsible pursuant to this Agreement or the Research and Development Plan. Subject to this Section 5.4.1 (Regulatory Communications and Filings), Novartis shall be the regulatory lead in the Territory and shall have primary responsibility for regulatory activities relating to the Licensed Products in the Territory, including preparing, submitting and maintaining all Regulatory Filings in the Territory in accordance with the Development Plan, and Amgen shall provide strategic input for such activities therefor as set forth in the Development Plan; [*]. Notwithstanding the foregoing or Section 3.5.2 (Regulatory), the Parties shall mutually agree on the timing of the filing strategy for marketing applications for each Licensed Product to be consistent with Amgen’s drug Manufacturing plans applicable to Licensed Product to be supplied for the Territory. Unless exigent action [*] is required with respect to a given filing before a such Regulatory Authority concerning a Candidate or Product, Filing or a material communication with a Regulatory Governmental Authority concerning the samewith respect to any Licensed Product, the lead regulatory Party submitting such Marketing Authorization Application shall provide the other Party with copies of all filings relating material Regulatory Filings (which, for clarity, shall not be required to such Marketing Authorization Application include communications that are solely administrative in nature) prior to submission within a reasonable amount of time and reasonably consider comments of such other Party (but not less than [***] Business Days) in the event of a disagreement between the Parties with respect to allow such Party to review and comment on such filings, and the Party submitting such Marketing Authorization Application shall consider all comments and proposed revisions from revisions, such matter shall be escalated to the other Party in good faith prior to submissionJSC for review). The lead regulatory Party responsible for filing such Regulatory Approvals shall consult with the other Party regarding, and keep the such other Party informed of, the status of the preparation of all Marketing Authorization Applications and the prosecution thereofRegulatory Filings (which, including any material for clarity, shall not be required to include communications that are solely administrative in nature) it receives submits, Governmental Authority review of any such Regulatory Filings, and all Regulatory Approvals that it obtains with respect to the sameLicensed Products. Upon request of the other Party, the Lead Development The lead regulatory Party responsible for filing applications for such Regulatory Approvals shall provide to the other Party copies of all final Marketing Authorization Applications Regulatory Filings it submits promptly after the submission (but in no event later than [*] days after submission). Through the JPT, the Parties shall agree to the point at which Novartis shall take the lead regulatory role in the Territory for purposes of performing Territory-specific clinical trials and filings relating thereto that it submits. The foregoing provisions supporting pricing and reimbursement in the Territory, with the intent of this Section 9.2.2 not interrupting Amgen’s regulatory activities with respect to the Licensed Products, providing Novartis with sufficient lead-time to conduct interactions with Governmental Authorities in connection with any [*] for such Licensed Product in the Territory and to hold pre-MAA meetings with the EMA and file the XXXx for the Licensed Products in the Territory, and to effect a smooth and efficient transfer (which shall also apply to material and substantive communications with Regulatory Authoritiesoccur no later than promptly following [*] in the U.S. for the applicable Licensed Product).

Regulatory Communications and Filings. Pfizer The Lead Regulatory Party shall prepare, file in BioNTech’s name, diligently use Commercially Reasonable Efforts to prosecute to grant, grant and maintain all applications for Regulatory Approvals (“Marketing Authorization Applications”) for the Product, including any supplements or amendments thereto and all Regulatory Approvals obtained therefrom in respect of any Candidates or Products in USA and, subject therefrom. The Lead Regulatory Party shall make all filings with the Regulatory Authority that are necessary to Section 9.2.1, maintain the ROW. BionTech shall prepare, file in BioNTech’s name, diligently prosecute to grant, and maintain all applications for Marketing Authorization Applications and all Regulatory Approvals obtained therefrom for the Product in respect of good standing, including any Candidates or Products in EU. The JSC may vary from the foregoing allocations by mutual consentregulatory reporting. In accordance with Section 9.2.18.2.1, each Party shall cooperate with the other Party with respect to any and all regulatory matters for which the other Party is responsible pursuant to this Agreement or the Research and Development Plan. Unless exigent action is required with respect to a given filing before a Regulatory Authority concerning a Candidate or Product, or a material communication with a Regulatory Authority concerning the same, the Lead Regulatory Party submitting such Marketing Authorization Application shall provide the other Party with copies of all filings relating to such Marketing Authorization Application prior to submission within a reasonable amount of time (but not less than [***] Business Days]) to allow such Party to review and comment on such filings, and the Party submitting such Marketing Authorization Application filing shall consider all comments and proposed revisions from the other Party in good faith prior to submission. The Lead Regulatory Party responsible for filing such Regulatory Approvals shall consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all Marketing Authorization Applications and the prosecution or maintenance thereof, including any material communications that it receives with respect to the same. Upon request of the other Party, the The Lead Development Regulatory Party responsible for filing applications for such Regulatory Approvals shall provide to the other Party copies of all final Marketing Authorization Applications and filings relating thereto that it submitssubmits within [***] from filing (unless access to such Marketing Authorization Applications or filing is reasonably required earlier in which case the Lead Regulatory Party shall make such Marketing Authorization Applications and filings available earlier than [***] to the extent reasonably possible). The foregoing provisions of this Section 9.2.2 8.2.2 shall also apply to material and substantive communications with Regulatory Authorities. Both Parties will cooperate with respect to any and all regulatory matters with respect to the Product, including the implementation of any of the foregoing in any country in the Territory. For the avoidance of doubt, where Pfizer is the Lead Regulatory Party, all filing, prosecution and maintenance activities to be made by Pfizer under this Section 8.2.2 shall be made in the name of BioNTech or its Affiliate, unless otherwise agreed pursuant to Section 8.2.6, and Pfizer shall submit or make available to BioNTech within [***] copies of all filings and other material correspondence submitted to any Regulatory Authority, Governmental Authority or Government Official worldwide in BioNTech’s name or on BioNTech’s behalf in connection with such Regulatory Approvals and applications therefor.