Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. The Parties acknowledge that the Products have not been reviewed or approved for sale or use for any purpose by any governmental or regulatory body. Advancis shall prepare any required application(s) for Regulatory Approval. Advancis shall own in their entirety (a) all clinical data and reports related to Product Studies including clinical trials for the Products and (b) all NDAs and other Regulatory Approvals for Products. Advancis shall [***] to inform Par of all communications with the FDA and to provide copies of FDA submissions to the Development and Manufacturing Subcommittee prior to their submission to FDA. The Parties shall cooperate in good faith with respect to, and Advancis shall [***] to enable representatives of Par to attend all formal meetings with the FDA relating to regulatory approval of the Products. The Parties shall cooperate in good faith with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. respect to the conduct of any inspections by any regulatory authority of a Party’s site and facilities related to the Products. To the extent either Party receives written or material oral communication from the FDA or any other regulatory authority relating to any Regulatory Approval process with respect to the Products, the Party receiving such communication shall notify the other Party and provide a copy of any written communication as soon as reasonably practicable.

Regulatory Submissions. The Parties acknowledge that the Products have not been reviewed or approved for sale or use for any purpose by any governmental or regulatory body. Advancis shall prepare any required application(s) for Regulatory Approval. Advancis shall own in their entirety (a) all clinical data and reports related to Product Studies including clinical trials for the Products and (b) all NDAs and other Regulatory Approvals for Products. Advancis shall [***] to inform Par of all communications with the FDA and to provide copies of FDA submissions to the Development and Manufacturing Subcommittee prior to their submission to FDA. The Parties shall cooperate in good faith with respect to, and Advancis shall [***] to enable representatives of Par to attend all formal meetings with the FDA relating to regulatory approval of the Products. The Parties shall cooperate in good faith with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 16 -------------------------------------------------------------------------------- respect to the conduct of any inspections by any regulatory authority of a Party’s 's site and facilities related to the Products. To the extent either Party receives written or material oral communication from the FDA or any other regulatory authority relating to any Regulatory Approval process with respect to the Products, the Party receiving such communication shall notify the other Party and provide a copy of any written communication as soon as reasonably practicable.

Regulatory Submissions. The Parties acknowledge Party that exercised the Products have not been reviewed or approved Option shall provide to the other Party for sale or use review and comment drafts of all Regulatory Submissions for any purpose by any governmental or regulatory body. Advancis shall prepare any required application(s) for Regulatory Approval. Advancis shall own a Licensed Program in their entirety the applicable Territory a reasonable amount of time prior to submission (a) all clinical data and reports related to Product Studies including clinical trials as appropriate for the Products and (b) all NDAs and other applicable Regulatory Approvals for Products. Advancis shall Submission), but at least [***] to inform Par of all communications with the FDA and to provide copies of FDA submissions to the Development and Manufacturing Subcommittee prior to their submission to FDAif the applicable Regulatory Authority does not require a response in a shorter time period. The Parties Party that exercised the Option providing the Regulatory Submissions shall cooperate consider in good faith any comments received from the other Party. In addition, the Party that exercised the EXECUTION VERSION Option shall notify the other Party of any comments or other correspondences related to such Regulatory Submissions submitted to or received from any Regulatory Authority in the applicable Territory with respect toto such Licensed Program and shall provide the other Party with copies thereof as soon as reasonably practicable, and Advancis shall but in all events within [***] to enable representatives of Par to attend all formal meetings after submission or receipt if the applicable Regulatory Authority does not require a response in a shorter time period. If any such Regulatory Submission, comment or correspondence is not in English, Brii Bio shall also provide Vir with the FDA relating to regulatory approval of the Products. The Parties shall cooperate in good faith with a certified English translation within [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDafter submission or receipt if requested by Vir; provided that Vir shall be responsible for the costs incurred by Brii Bio in obtaining such certified translation. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934The other Party may review and comment on such Regulatory Submissions and [***]. Notwithstanding the anything to the contrary in this Section 7.1(b), AS AMENDED. with respect to the conduct of any inspections applications for a New Drug Application (as defined by any regulatory authority of a Party’s site and facilities related to the Products. To the extent either Party receives written or material oral communication from the FDA or any other regulatory authority relating to any Regulatory Approval process with respect to CFDA, as applicable) or a Biologics License Application (as defined by the ProductsFDA, and the equivalent in the China Territory) or supplemental applications of either of the foregoing, the Party receiving making such communication Regulatory Submission shall notify keep the JDC of the applicable Collaboration Program reasonably informed of the process of preparing such Regulatory Submissions so that the other Party may expeditiously review and provide a copy comments to such Regulatory Submissions, and such other Party shall use reasonable efforts to provide such comments within [***] after receipt of any written communication as soon as reasonably practicablesuch Regulatory Submissions.

Regulatory Submissions. (i) The Parties acknowledge that the Products have not no Product has been reviewed or approved for sale or use for any purpose as a human therapeutic product by any governmental or regulatory bodyGovernmental Authority. Advancis Subject to Section 3.1, Alfacell shall prepare any required application(s) for Regulatory ApprovalApproval in the Field in the Territory. Advancis Unless otherwise agreed by the Parties, Alfacell shall own own, in their entirety (a) its entirety, all clinical data and reports related to Product Studies including clinical trials for the Products Product; provided, however, that, during the Term, Par shall have the right to (i) obtain copies of, and to use, Alfacell Information that is included in Alfacell’s NDA for the Product for an Indication, as Par reasonably determines is necessary or desirable to further the Commercialization of the Product in the Field in the Territory, and (bii) request copies of, and to use, Alfacell Information that is not included in Alfacell’s NDA for the Product for an Indication, with Alfacell’s consent (such consent not to be unreasonably withheld) as Par reasonably determines is necessary or desirable to further the Commercialization of the Product in the Field in the Territory. At all NDAs times both prior to and other following Regulatory Approvals for Products. Advancis Approval of the Product in the Field in the Territory, Alfacell shall [***] to (A) inform Par of all substantive communications with from the FDA concerning the NDA and any other material communications from the FDA concerning the Product in the Field within forty-eight (48) hours of receipt thereof, such substantiality and materiality to be solely based on Alfacell’s reasonable evaluation, and (B) provide copies of proposed material FDA communications and submissions concerning the Product to the Development Committee and Manufacturing Subcommittee Par prior to their submission to the Confidential information omitted and filed with the Securities and Exchange Commission. Asterisks denote such omission. FDA, subject to the extent practicable, as described below. The Parties Except to the extent that Alfacell must respond to the FDA or make a submission to the FDA before receipt of the Development Committee’s and/or Par’s comments, Alfacell will not respond substantively in writing to any FDA communication or otherwise make any written submissions to the FDA concerning, in either case, the Product in the Field without first giving Par a reasonable opportunity to review and comment thereon. Such opportunity shall cooperate not exceed ten (10) days, unless otherwise required by the FDA, in which case Alfacell shall use Commercially Reasonable Efforts to provide Par with an opportunity to review and comment to the extent practicable, but Par agrees that Alfacell shall be entitled to respond in any manner as Alfacell determines in its reasonable discretion is appropriate given the timing of the FDA regulatory review process. Alfacell shall review and consider in good faith with respect to, and Advancis shall [***] any comments received from Par related to enable representatives of Par to attend all formal meetings with the such FDA relating to regulatory approval of the Products. The Parties shall cooperate in good faith with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. respect to the conduct of any inspections by any regulatory authority of a Party’s site and facilities communications or submissions related to the ProductsProduct in the Field, and any comments or suggestions timely received from Par that are otherwise related to Regulatory Approvals for the Product in the Field in the Territory. To For the extent either Party receives written or material oral communication from sake of clarity, the Parties recognize that the FDA regulatory review process may involve both non-Commercialization (i.e., development and/or manufacturing) and Commercialization aspects of the Product in the Field in the Territory (for example, proposed labeling of the Product for a given Indication). If any such intersection or any other regulatory overlap of Alfacell’s final decision-making authority relating to any Regulatory Approval process with respect regarding development and manufacturing and Par’s final decision-making authority regarding Commercialization results in a dispute or disagreement, such dispute or disagreement shall be referred to the ProductsCEO of Alfacell and the CEO of Par for resolution, and the Party receiving such communication CEOs shall notify resolve the other Party and provide a copy of any written communication as soon as reasonably practicablematter (without resort to Section 14.5).

Regulatory Submissions. The Parties acknowledge that To the extent permitted by Applicable Law, each Party’s regulatory team shall reasonably cooperate with the other Party’s regulatory team regarding Drug Approval Applications and other material Regulatory Submissions for Products have not been reviewed or approved in all markets for sale or use which such Party is the Regulatory/Reimbursement Responsible Party. In addition, to the extent permitted by Applicable Law, each Party shall provide the other Party with a reasonable opportunity to review and comment on all material Regulatory Submissions for any purpose Product to be submitted to any Regulatory Authority in the Apellis Territory or any Major Market by any governmental or regulatory body. Advancis on behalf of such Party (including Drug Approval Applications, material correspondence, meeting requests, briefing materials, and minutes) throughout the process of preparing such Regulatory Submissions and, in particular, shall prepare any required application(s) for Regulatory Approval. Advancis shall own in their entirety (a) all clinical data and reports related to Product Studies including clinical trials for the Products and (b) all NDAs and provide such other Regulatory Approvals for Products. Advancis shall [***] to inform Par Party with drafts of all communications with such Regulatory Submissions on the FDA and timeline agreed to provide copies of FDA submissions to by the Development and Manufacturing Subcommittee prior to their submission to FDA. The Parties shall cooperate in good faith with respect to, in writing prior to the date such Regulatory Submissions are to be finalized to allow for such other Party’s review and Advancis comment. Each Party shall [***] to enable representatives of Par to attend all formal meetings with the FDA relating to regulatory approval of the Products. The Parties shall cooperate consider in good faith with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934(and, AS AMENDED. respect to the conduct of any inspections by any regulatory authority of a Party’s site and facilities related to the Products. To the extent either Party receives written or material oral communication from the FDA or any other regulatory authority relating to any Regulatory Approval process with respect to the ProductsEMA PNH Regulatory Approval, the Party receiving such communication Apellis shall notify not unreasonably decline to implement) all timely, reasonable comments from the other Party and regarding such Party’s Regulatory Submissions for Products in the Apellis Territory or any Major Market and, within [**] after submitting any Regulatory Submission for any Product to any Regulatory Authority in the Apellis Territory or any 58 Major Market provide a copy of any written communication as soon such final Regulatory Submission to the other Party. Each Party shall cooperate with the other Party as reasonably practicablerequested by such other Party to assist such other Party’s efforts to prepare and submit any Regulatory Submissions for Products under this Agreement, including by providing all such supporting documentation for INDs, CTAs, Drug Approval Applications, and other Regulatory Submissions to such other Party as are reasonably requested by such other Party with reasonably sufficient time to allow such other Party to review and incorporate such documentation and timely submit such Regulatory Submissions in accordance with Applicable Law or any other requirements or requests of any applicable Regulatory Authority.

Regulatory Submissions. (i) The Parties acknowledge that the Products have not no Product has been reviewed or approved for sale or use for any purpose as a human therapeutic product by any governmental or regulatory bodyGovernmental Authority. Advancis Subject to Section 3.1, Alfacell shall prepare any required application(s) for Regulatory ApprovalApproval in the Field in the Territory. Advancis Unless otherwise agreed by the Parties, Alfacell shall own own, in their entirety (a) its entirety, all clinical data and reports related to Product Studies including clinical trials for the Products Product; provided, however, that, during the Term, Par shall have the right to (i) obtain copies of, and to use, Alfacell Information that is included in Alfacell’s NDA for the Product for an Indication, as Par reasonably determines is necessary or desirable to further the Commercialization of the Product in the Field in the Territory, and (bii) request copies of, and to use, Alfacell Information that is not included in Alfacell’s NDA for the Product for an Indication, with Alfacell’s consent (such consent not to be unreasonably withheld) as Par reasonably determines is necessary or desirable to further the Commercialization of the Product in the Field in the Territory. At all NDAs times both prior to and other following Regulatory Approvals for Products. Advancis Approval of the Product in the Field in the Territory, Alfacell shall [***] to (A) inform Par of all substantive communications with from the FDA concerning the NDA and any other material communications from the FDA concerning the Product in the Field within forty-eight (48) hours of receipt thereof, such substantiality and materiality to be solely based on Alfacell’s reasonable evaluation, and (B) provide copies of proposed material FDA communications and submissions concerning the Product to the Development Committee and Manufacturing Subcommittee Par prior to their submission to the FDA, subject to the extent practicable, as described below. The Parties Except to the extent that Alfacell must respond to the FDA or make a submission to the FDA before receipt of the Development Committee’s and/or Par’s comments, Alfacell will not respond substantively in writing to any FDA communication or otherwise make any written submissions to the FDA concerning, in either case, the Product in the Field without first giving Par a reasonable opportunity to review and comment thereon. Such opportunity shall cooperate not exceed ten (10) days, unless otherwise required by the FDA, in which case Alfacell shall use Commercially Reasonable Efforts to provide Par with an opportunity to review and comment to the extent practicable, but Par agrees that Alfacell shall be entitled to respond in any manner as Alfacell determines in its reasonable discretion is appropriate given the timing of the FDA regulatory review process. Alfacell shall review and consider in good faith with respect to, and Advancis shall [***] any comments received from Par related to enable representatives of Par to attend all formal meetings with the such FDA relating to regulatory approval of the Products. The Parties shall cooperate in good faith with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. respect to the conduct of any inspections by any regulatory authority of a Party’s site and facilities communications or submissions related to the ProductsProduct in the Field, and any comments or suggestions timely received from Par that are otherwise related to Regulatory Approvals for the Product in the Field in the Territory. To For the extent either Party receives written or material oral communication from sake of clarity, the Parties recognize that the FDA regulatory review process may involve both non-Commercialization (i.e., development and/or manufacturing) and Commercialization aspects of the Product in the Field in the Territory (for example, proposed labeling of the Product for a given Indication). If any such intersection or any other regulatory overlap of Alfacell’s final decision-making authority relating to any Regulatory Approval process with respect regarding development and manufacturing and Par’s final decision-making authority regarding Commercialization results in a dispute or disagreement, such dispute or disagreement shall be referred to the ProductsCEO of Alfacell and the CEO of Par for resolution, and the Party receiving such communication CEOs shall notify resolve the other Party and provide a copy of any written communication as soon as reasonably practicablematter (without resort to Section 14.5).

Regulatory Submissions. The Parties acknowledge that From and after the Products have not been reviewed Effective Date, Licensee will be responsible, at its sole cost and expense, for preparing, filing, and submitting, directly or approved for sale or use for any purpose by any governmental or regulatory body. Advancis shall prepare any required application(s) for Regulatory Approval. Advancis shall own in their entirety through its Affiliates and permitted Sublicensees, (a) all clinical data Regulatory Submissions in all countries and reports related to Product Studies including clinical trials for jurisdictions in the Products Territory, and each material amendment or update thereto, in its name; and (b) all NDAs briefing packages for meetings with Regulatory Authorities relating to Regulatory Submissions in each such country and jurisdiction in the Territory for such Licensed Product. Akebia will reasonably cooperate in a timely manner (i.e., in accordance with the timelines imposed by the Regulatory Authorities) with Licensee in obtaining any Regulatory Approvals and Reimbursement Approvals, as applicable, for the Licensed Product in the Territory by providing access to Regulatory Approvals, Regulatory Submissions, clinical data, and other data, information, and documentation for the Licensed Product that is relevant to obtaining or maintaining Regulatory Approvals Approval for Products. Advancis shall [***] to inform Par of all communications with the FDA and to provide copies of FDA submissions Licensed Product in the Field in the Territory, to the Development extent Controlled by Akebia. In the event Akebia determines in its sole discretion that Licensee’s request for cooperation by Xxxxxx is not reasonable, then Licensee and Manufacturing Subcommittee prior to their submission to FDAXxxxxx will meet and discuss regarding such requested cooperation. The Parties shall cooperate acknowledge and agree that Akebia may determine in its sole discretion whether any requested cooperation by Licensee is reasonable, and that Akebia has no obligation to provide any assistance to Licensee under this Section 4.2.2 (Regulatory Submissions). If Akebia provides any such requested cooperation to Licensee pursuant to this Section 4.2.2 (Regulatory Submissions), then Akebia will provide to Averoa a good faith calculation of the costs and expenses incurred by Akebia in connection with such cooperation, and the Parties will discuss in good faith with respect towhether Xxxxxx will reimburse Akebia for such costs and expenses. For clarity, and Advancis shall [***] Akebia will not be required to enable representatives of Par to attend all formal meetings expend any resources, whether internal or external, in connection with the FDA relating Development of, including obtaining or maintaining Regulatory Approval for, the Licensed Product unless expressly agreed by Xxxxxx in writing. Licensee will provide to regulatory approval Akebia for review and comment drafts of all Regulatory Submissions in the ProductsTerritory for the Licensed Product. The Parties shall cooperate Licensee will consider in good faith with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTEDand, where appropriate, incorporate any such comments received from Akebia on such Regulatory Submissions. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934In addition, AS AMENDED. respect to the conduct Licensee will notify Akebia of any inspections by Regulatory Submissions for the Licensed Product and any regulatory authority of a Party’s site and facilities comments or other correspondences related thereto submitted to the Products. To the extent either Party receives written or material oral communication received from the FDA or any other regulatory authority relating to any Regulatory Approval process Authority in the Territory and will provide Akebia with respect to the Products, the Party receiving such communication shall notify the other Party and provide a copy of any written communication copies thereof as soon as reasonably practicable, but in all events within [**] after submission or receipt thereof (or such longer time period as may be necessary to obtain translations thereof). If any such Regulatory Submission, comment, or correspondence is not in English, then Licensee will provide Akebia with a certified English translation as soon as practicable after receipt of such Regulatory Submission, comment, or correspondence, at Licensee’s sole cost and expense. Akebia will have the right, but not the obligation, to review and comment on all such Regulatory Submissions, and Licensee will consider in good faith and incorporate such comments where appropriate.