Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. (i) The Parties acknowledge that no Product has been reviewed or approved for sale or use as a human therapeutic product by any Governmental Authority. Subject to Section 3.1, Alfacell shall prepare any required application(s) for Regulatory Approval in the Field in the Territory. Unless otherwise agreed by the Parties, Alfacell shall own, in its entirety, all clinical data and reports related to Product Studies including clinical trials for the 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 (ii) 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 times both prior to and following Regulatory Approval of the Product in the Field in the Territory, Alfacell shall (A) inform Par of all substantive communications 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 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. 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 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 any comments received from Par related to such FDA communications or submissions related to the Product 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. For the 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 overlap of Alfacell’s final decision-making authority 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 CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5). (ii) The Parties shall cooperate in good faith with respect to obtaining, and Alfacell shall use Commercially Reasonable Efforts to enable representatives of Par to attend, if and as requested by Par and as permitted by the FDA, formal meetings with the FDA relating to Regulatory Approval of the Product in the Field in the Territory. The Parties shall cooperate in good faith with respect to the conduct of any inspections by the FDA or equivalent foreign regulatory authority of a Party’s site and facilities related to the Product. To the extent either Party receives any material written or oral communication from the FDA or equivalent foreign regulatory authority relating to the Regulatory Approval process with respect to the Product in the Field in the Territory, the Party receiving such communication shall promptly notify the other Party and provide a copy of such written communication and/or a written summary of such oral communication as soon as reasonably practicable. (iii) If “ONCONASE®” is not approved by the FDA as the Product Trade Name, Alfacell shall not submit any other Trade Name(s) for the Product for approval by the FDA unless such other Trade Name(s) has (have) been mutually agreed by the Parties. Subject to the license rights granted herein, Alfacell shall own all right, title, and interest to ONCONASE and all such Trade Names and intellectual property rights related thereto (including trademark and copyright), and Par shall (A) assign any right, title, and interest it has in any Trade Names (including intellectual property rights related thereto (including trademark and copyright)) to Alfacell, free and clear of all liens, claims, and encumbrances, and (B) take any and all actions reasonably requested by Alfacell in furtherance of the foregoing. *** related to the choosing of any new Trade Name for the Product in the Field in the Territory, including any market research studies conducted by Par pertaining to ONCONASE or any new proposed Trade Name(s) for the Product. Confidential information omitted and filed with the Securities and Exchange Commission. Asterisks denote such omission.

Regulatory Submissions. (i) The Parties acknowledge that no Licensed Product has been reviewed or approved for sale or use in the Field as a human therapeutic product by any Governmental AuthorityRegulatory Authority in the Territory. Subject Athenex shall use Commercially Reasonable Efforts to Section 3.1prepare and file, Alfacell and shall prepare be responsible for the preparation and filling of, in the United States (i) the initial NDA for the Current Product, including any supplementary and supportive filings necessary to support such NDA and its consideration by the FDA, and (ii) any required application(sIND(s) for Regulatory the Line Extension Phase II Study and any reporting obligations with respect to any Athenex Studies. Upon approval of the initial NDA for the Current Product in the U.S. in the Field, Athenex shall immediately and at no cost to Aqua assign all right, title, and interest therein to Aqua, and Aqua shall thereafter be responsible for all regulatory obligations with respect to Licensed Products in the Territory. Thereafter, the NDA will be considered part of Almirall’s Intellectual Property and Proprietary Information. Athenex shall conduct all such regulatory activities in accordance with the timelines included in the Development Plan. (ii) Almirall shall use Commercially Reasonable Efforts to prepare and file, and be responsible for the preparation and filing of, all Drug Approval Applications for (i) any Licensed Products in the Field in the Territory. Unless otherwise agreed by U.S. other than the Parties, Alfacell shall own, in its entirety, Current Product (which responsibility for preparing and filing correspond to Athenex) (including the Line Extension Product) and (ii) all clinical data and reports related to Product Studies including clinical trials for the 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 Licensed Products in the Field in all other countries in the Territory. In the event Almirall intends to file any Drug Approval Application for any Licensed Product in the Territory prior to receipt of initial Regulatory Approval of the Current Product in the U.S., Almirall may consult with Athenex with respect to the form and content of any such Drug Approval Application (and any related correspondence). Except as set forth in the preceding subsection (i), Almirall or Aqua, as applicable, shall be the holder of all Drug Approval Applications and Regulatory Approvals in the Territory with respect to Licensed Products in the Field. (iii) At all times, the Party responsible for preparing and filing applications for Regulatory Approval for a particular Licensed Product or indication thereof in the Field in a particular country of the Territory shall (z) be responsible for the corresponding regulatory fees and cost, including internal or external costs incurred in conducting such regulatory activities; (y) provide detailed information to the Joint Steering Committee and to the other Party before conducting any such activities and before interacting with any Regulatory Authority; (x) inform to the Joint Steering Committee and the other Party of all communications with the relevant Regulatory Authority(ies) in such country concerning the Licensed Product; (w) provide copies of proposed submissions to the relevant Regulatory Authority(ies) in such country concerning the Licensed Product to the Joint Steering Committee and the other Party prior to their submission to such Regulatory Authority; and (iiv) request copies offollow the Joint Steering Committee’s instructions in this regard, if any. (iv) Notwithstanding the foregoing, the responsible Party for preparing and filing applications for a particular Licensed Product or indication thereof in the Field in a particular country of the Territory will not respond substantively to useany communication with a particular Regulatory Authority or otherwise make any submissions to a Regulatory Authority concerning, Alfacell Information that is in either case, the Licensed Product in the Field, without first giving the other Party a reasonable opportunity to review and comment, such opportunity not included to be required to exceed ten (10) Business Days, unless the urgency of such matter and its related response reasonably precludes providing the other Party such an opportunity, in Alfacell’s NDA which case the responsible Party shall be entitled to respond as it determines in its reasonable discretion. The Party responsible for filing an application for Regulatory Approval in a particular country of the Territory shall review and consider in good faith any reasonable comments received from the other Party related to communications or submissions to and from the relevant Regulatory Authority(ies) in such country related to any Licensed Product and any reasonable comments or suggestions from the other Party otherwise related to any of the Regulatory Approvals for an Indicationany Licensed Product in such country. In the event the other Party raises any reasonable, objection to any such submission to a Regulatory Authority, including the proposed Product Label or any formulation changes, such matters shall be subject to resolution by the Joint Steering Committee. If the Joint Steering Committee becomes deadlocked with Alfacellrespect to such matters, such matters shall be as determined by Athenex when affecting only to the U.S and by Almirall when affecting only to Europe, in its reasonable discretion, except that, in such cases, Athenex may not, without Almirall’s consent (such consent not to be unreasonably withheld, conditioned or delayed), so determine any matter in a manner that (i) as Par is reasonably determines is necessary or desirable likely to further adversely affect the Commercialization of the Product in the Field in the Territory. At all times both prior to and following Regulatory Approval of the a Licensed Product in the Field in the Territory, Alfacell shall including changes to Product Labeling that are reasonably likely to have such an effect, (Aii) inform Par of all substantive communications from the FDA concerning the NDA and is reasonably likely to materially increase 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 costs to be solely based on Alfacell’s reasonable evaluationpaid by Almirall under this Agreement or the Supply Agreement, and (Biii) provide copies of proposed material FDA communications and submissions concerning materially changes the intended indications for which a Licensed Product to the Development Committee and 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. 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 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 any comments received from Par related to such FDA communications or submissions related to the Product in the Field, and any comments or suggestions timely received from Par that are otherwise related to Regulatory Approvals for the Product developed in the Field in the Territory. For the sake of clarity, the Parties recognize that the FDA regulatory review process (iv) may involve both non-Commercialization (i.e., development and/or manufacturing) and Commercialization aspects impact Almirall’s future obligations as holder of the Product in Regulatory Approvals, or (v) reasonably likely to affect the Field in the Territory (for example, proposed labeling of the Product for a given Indication)Post-Approval Development Activities. If any such intersection or overlap of Alfacell’s final decision-making authority 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 CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5). (ii) The Parties shall cooperate in good faith with respect to obtaining, and Alfacell each Party shall use its Commercially Reasonable Efforts to enable representatives an employee of Par the other Party to attend, if and as requested by Par and as permitted by the FDAother Party, all formal meetings with the FDA any Regulatory Authority relating to to, Regulatory Approval of the any Licensed Product in the Field in the Territory. The Parties shall cooperate in good faith with respect to the conduct of any inspections by the FDA or equivalent foreign regulatory authority of a Party’s site and facilities related to the Product. . (v) To the extent either Party receives any material written or material oral communication from the FDA or equivalent foreign regulatory authority any other Regulatory Authority relating to the any Regulatory Approval process with respect to the any Licensed Product in the Field in the Territory, the Party receiving such communication shall promptly notify the other Party and provide a copy of such any written communication and/or a written summary of such oral communication as soon as reasonably practicable. (iiivi) If “ONCONASE®” is not approved by the FDA as the Product Trade Name, Alfacell shall not submit Athenex represents and warrants to Almirall that no trademarks nor trade names for any other Trade Name(s) for the Product for approval by the FDA unless such other Trade Name(s) has (have) been mutually agreed by the Parties. Subject to the license rights granted herein, Alfacell shall own all right, title, and interest to ONCONASE and all such Trade Names and intellectual property rights related thereto (including trademark and copyright), and Par shall (A) assign any right, title, and interest it has in any Trade Names (including intellectual property rights related thereto (including trademark and copyright)) to Alfacell, free and clear of all liens, claims, and encumbrances, and (B) take any and all actions reasonably requested by Alfacell in furtherance of the foregoing. *** related to the choosing of any new Trade Name for the Product Licensed Products in the Field in the Territory, including Territory have been submitted to any market research studies conducted by Par pertaining Regulatory Authority in the Territory prior to ONCONASE or any new proposed Trade Name(s) for the Product. Confidential information omitted and filed with the Securities and Exchange Commission. Asterisks denote such omissionExecution Date.

Regulatory Submissions. (i) The Parties acknowledge that no Product has been reviewed or approved for sale or use as a human therapeutic product by any Governmental Authority. Subject to Section 3.1, Alfacell shall prepare any required application(s) for Regulatory Approval in the Field in the Territory. Unless otherwise agreed by the Parties, Alfacell shall own, in its entirety, all clinical data and reports related to Product Studies including clinical trials for the 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 (ii) 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 times both prior to and following Regulatory Approval of the Product in the Field in the Territory, Alfacell shall (A) inform Par of all substantive communications 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 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. 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 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 any comments received from Par related to such FDA communications or submissions related to the Product 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. For the 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 overlap of Alfacell’s final decision-making authority 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 CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5). (ii) The Parties shall cooperate in good faith with respect to obtaining, and Alfacell shall use Commercially Reasonable Efforts to enable representatives of Par to attend, if and as requested by Par and as permitted by the FDA, formal meetings with the FDA relating to Regulatory Approval of the Product in the Field in the Territory. The Parties shall cooperate in good faith with respect to the conduct of any inspections by the FDA or equivalent foreign regulatory authority of a Party’s site and facilities related to the Product. To the extent either Party receives any material written or oral communication from the FDA or equivalent foreign regulatory authority relating to the Regulatory Approval process with respect to the Product in the Field in the Territory, the Party receiving such communication shall promptly notify the other Party and provide a copy of such written communication and/or a written summary of such oral communication as soon as reasonably practicable. (iii) If “ONCONASE®” is not approved by the FDA as the Product Trade Name, Alfacell shall not submit any other Trade Name(s) for the Product for approval by the FDA unless such other Trade Name(s) has (have) been mutually agreed by the Parties. Subject to the license rights granted herein, Alfacell shall own all right, title, and interest to ONCONASE and all such Trade Names and intellectual property rights related thereto (including trademark and copyright), and Par shall (A) assign any right, title, and interest it has in any Trade Names (including intellectual property rights related thereto (including trademark and copyright)) to Alfacell, free and clear of all liens, claims, and encumbrances, and (B) take any and all actions reasonably requested by Alfacell in furtherance of the foregoing. *** related to the choosing of any new Trade Name for the Product in the Field in the Territory, including any market research studies conducted by Par pertaining to ONCONASE or any new proposed Trade Name(s) for the Product. Confidential information omitted and filed with the Securities and Exchange Commission. Asterisks denote such omission.

Regulatory Submissions. (a) In each case ((i) The Parties acknowledge that no Product has been reviewed or approved for sale or use as a human therapeutic product by any Governmental Authority. Subject to Section 3.1, Alfacell shall prepare any required application(sand (ii)) for other than Regulatory Approval in the Field in the Territory. Unless otherwise agreed by the Parties, Alfacell shall own, in its entirety, all clinical data and reports Submissions related to Product Studies including clinical trials for Regulatory Approvals (the Product; providedownership of which is addressed in Section 9.1(e)), however, that, during the Term, Par shall have the right to (i) obtain copies of, MacroGenics or its designee shall hold and own all Regulatory Submissions that are submitted to use, Alfacell Information that is included in Alfacell’s NDA for the Product for an Indication, as Par reasonably determines is necessary Regulatory Authorities under the Global Development Plan or desirable related to further the Commercialization of the Product in the Field in the Territory, or resulting from any MacroGenics Global Clinical Trial(s); and (ii) request subject to Applicable Laws and Regulations, I-MAB and MacroGenics or their respective designees shall jointly hold and own all other Regulatory Submissions that are submitted to Regulatory Authorities in the Territory under the Territory Specific Development Plan (“Territory Specific Regulatory Submissions”). For any Territory Specific Regulatory Submission which the Parties are not legally permitted to jointly own according to Applicable Laws and Regulations (i) MacroGenics shall be the sole and exclusive owner of any Territory Specific Regulatory Submission that MacroGenics is required by Applicable Laws and Regulations to hold and own in order for MacroGenics to be the sole and exclusive owner of the Regulatory Approvals that cover Indications addressed under the Global Development Plan and (ii) I-MAB shall be the sole and exclusive owner of all other Territory Specific Regulatory Submissions. I-MAB shall promptly provide all copies ofof Regulatory Submissions (including all updates thereof) to MacroGenics. (b) I-MAB shall be responsible for, in I-MAB’s or its designees’ names ([***]) and/or MacroGenics’ or its designees’ names ([***]), at I-MAB’s sole cost and expense, (x) the filing and obtaining all Regulatory Submissions, (y) responding to inquiries and correspondence from the Regulatory Authorities responsible for regulatory matters, and (z) the monitoring of all clinical experiences (to usethe extent [***], Alfacell Information that is not included in Alfacell’s NDA which case, such Permitted Contractor shall be responsible for the Product such monitoring and [***]) and submission of all required reports throughout clinical Development and Commercialization, in each case ((x) through (z)) in or 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 times both prior to and following Regulatory Approval of the Product in the Field in the Territory, Alfacell in compliance with all Applicable Laws And Regulations. I-MAB shall (A) inform Par notify MacroGenics of all substantive communications 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 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. 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 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 any comments received from Par related to such FDA communications or submissions related to the Product 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. For the 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 overlap of Alfacell’s final decision-making authority 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 CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5). (ii) The Parties shall cooperate in good faith with respect to obtaining, and Alfacell shall use Commercially Reasonable Efforts to enable representatives of Par to attend, if and as requested by Par and as permitted by the FDA, formal meetings with the FDA relating to Regulatory Approval of the Product in the Field in the Territory. The Parties shall cooperate in good faith with respect to the conduct of any inspections by the FDA or equivalent foreign regulatory authority of a Party’s site and facilities related to the Product. To the extent either Party receives any material written or oral electronic communication received by I-MAB from the FDA or equivalent foreign regulatory authority relating to the a Regulatory Approval process with respect to the Product Authority in the Field in the Territory, the Party receiving Territory regarding a Product or MGA012 [***] of receipt of such communication shall promptly notify the other Party and upon MacroGenics’ request, provide a copy of such written communication and/or a written summary that has been translated into English [***] of receipt of such oral request unless otherwise specified by MacroGenics, provided, however, in the event I-MAB receives a material communication from a Regulatory Authority that [***] to be submitted [***], I-MAB shall provide a copy of such communication to MacroGenics [***]. MacroGenics shall be responsible for providing to I-MAB any revisions to the investigator’s brochure and CMC information required for Regulatory Submissions. MacroGenics (or its designee) shall have a right to participate (and I- MAB may otherwise request MacroGenics to participate) in meetings with the Regulatory Authorities regarding (i) any Product or (ii) MGA012. Each Party shall provide information to the other Party as soon as necessary, and reasonably practicable. (iii) If “ONCONASE®” is not approved consult with the other Party regarding any filings, and regarding significant or material notices, actions or requests from or by Regulatory Authorities. Each Party shall, at the FDA as the Product Trade Nameother Party’s request, Alfacell shall not submit review and comment on filings, submissions, and responses to Regulatory Authorities related to any other Trade Name(s) for the Product for approval by the FDA unless such other Trade Name(s) has (have) been mutually agreed by Product. As between the Parties. Subject to the license rights granted herein, Alfacell MacroGenics shall own all right, titlebe responsible for, and interest shall bear all costs related to ONCONASE (x) the filing and obtaining all such Trade Names Regulatory Submissions, (y) responding to inquiries and intellectual property rights related thereto (including trademark and copyright), and Par shall (A) assign any right, title, and interest it has in any Trade Names (including intellectual property rights related thereto (including trademark and copyright)) to Alfacell, free and clear of all liens, claims, and encumbrancescorrespondence from the Regulatory Authorities responsible for regulatory matters, and (Bz) take any the monitoring of all clinical experiences and submission of all actions reasonably requested by Alfacell required reports throughout clinical Development and Commercialization, in furtherance each case ((x) through (y)) outside of the foregoing. *** related to the choosing of any new Trade Name for the Product in the Field in the Territory, including in MacroGenics’ sole discretion. To the extent a Regulatory Authority requests from I-MAB, an Affiliate or a Sublicensee information regarding the Product or Combination Regimen that I-MAB, such Affiliate or such Sublicensee reasonably believes is required to be submitted to a Regulatory Authority in order to obtain Regulatory Approval for any market research studies conducted by Par pertaining Product, then MacroGenics, upon request, shall provide reasonably requested assistance, materials, Data or Know-How in its possession that would be required to ONCONASE or any new proposed Trade Name(ssatisfy such Regulatory Authority request. To the extent that MacroGenics is aware that the applicable information described in this Section 6.2(b) for the Product. Confidential is with a MacroGenics Sublicensee, then MacroGenics will use reasonable efforts to obtain such information omitted and filed with the Securities and Exchange Commission. Asterisks denote from such omissionMacroGenics Sublicensee.

Regulatory Submissions. (i) The Parties acknowledge that no Licensed Product has been reviewed or approved for sale or use as a human therapeutic product by any Governmental Authority. Subject BDSI shall use Commercially Reasonable Efforts to Section 3.1, Alfacell shall prepare any and file in the United States all required application(s) for Regulatory Governmental Approval of the Fentanyl Product for the First Indication, including the ***. Subject to Section 2.03(c), BDSI shall prepare, or cause to be prepared by a Third Party, and file simultaneously with the filing of the NDA, a proposed final draft RiskMAP with respect to the First Indication of the Fentanyl Product. Notwithstanding anything to the contrary in this Agreement, Meda shall use Commercially Reasonable Efforts to prepare and file, and be responsible for the preparation and filing of, all required application(s) for Governmental Approval of the Licensed Products in all other countries in the Field Territory (including, on a Licensed Product-by-Licensed Product basis, Governmental Approvals for all indications approved by FDA in the Territory. Unless otherwise agreed by the PartiesUnited States), Alfacell shall own, in its entirety, all clinical data and reports related to Product Studies including clinical trials for the Product; provided, however, that, during the Term, Par shall have the right to provided that (i) obtain copies ofMeda shall not, by act or omission, in the course of exercising such rights and satisfying such obligations, create any circumstance reasonably likely to use, Alfacell Information that is included in Alfacell’s NDA for materially adversely affect the Product for an Indication, as Par reasonably determines is necessary development or desirable to further the Commercialization of the any Licensed Product in any country of the Field Territory without BDSI’s prior written consent and, in the Territoryevent Meda intends to file any application(s) for Governmental Approval for Licensed Products in such other jurisdictions in the Territory prior to receipt of Governmental Approval thereof in the United States, (ii) the form and content of any such application (and any related correspondence) shall, notwithstanding anything to the contrary herein, be subject to BDSI’s prior written consent. (ii) At all times, the Party responsible for preparing and filing applications for Governmental Approval in a particular country of the Territory (i.e. BDSI in the United States, Meda in Mexico and Canada) shall (i) inform the other Party of all material communications with the relevant Competent Authority(ies) in such country concerning the Licensed Product and (ii) request provide copies ofof proposed material submissions to the relevant Competent Authority(ies) in such country concerning the Licensed Product to the Development Committee and the other Party prior to their submission to such Competent Authority. At all times, the responsible Party in a particular country of the Territory will not respond substantively to any material communication with a particular Competent Authority or otherwise make any submissions to a Competent Authority concerning, in either case, the Licensed Product, without first giving the other Party a reasonable opportunity to review and comment, such opportunity not to usebe required to exceed ***, Alfacell Information that is not included unless the urgency of such matter and its related response reasonably precludes providing the other Party such an opportunity, in Alfacell’s NDA which case the responsible Party shall be entitled to respond as it determines in its reasonable discretion. The Party responsible for filing an application for Governmental Approval in a particular country of the Territory shall review and consider in good faith any reasonable comments received from the other Party related to material communications or material submissions to and from the relevant Competent Authority(ies) in such country related to any Licensed Product and any reasonable comments or suggestions from the other Party otherwise related to any of the Governmental Approvals for an Indicationany Licensed Product in such country. In the event the other Party raises any reasonable, material objection to any such submission to a Competent Authority, including the proposed label or any formulation changes, such matters shall be subject to resolution by the Development Committee unless timing constraints make submission of the matter to the Development Committee reasonably impracticable or the Development Committee becomes deadlocked with Alfacellrespect to such matters, in which case such matters shall be as determined by BDSI, in its reasonable discretion, except that, in such case, BDSI may not, without Meda’s consent (such consent not to be unreasonably withheld), so determine any matter in a manner that (i) as Par is reasonably determines likely to materially increase any Development Costs to be paid by Meda, (ii) materially changes the intended indications for which a Licensed Product is necessary or desirable developed, or (iii) is reasonably likely to further materially adversely affect the Commercialization of the Product in the Field in the Territory. At all times both prior a Licensed Product, including changes to labeling and following Regulatory Approval of the Product in the Field in the Territory, Alfacell shall (A) inform Par of all substantive communications 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 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. 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 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 any comments received from Par related to such FDA communications or submissions related to the Product in the Field, and any comments or suggestions timely received from Par RiskMAP procedures that are otherwise related reasonably likely to Regulatory Approvals for the Product in the Field in the Territoryhave such an effect. For the 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 overlap of Alfacell’s final decision-making authority 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 CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to Section 14.5). (ii) The Parties shall cooperate in good faith with respect to obtaining, and Alfacell each Party shall use its Commercially Reasonable Efforts to enable representatives an employee of Par the other Party to attend, if and as requested by Par and as permitted by the FDAother Party, all formal meetings with the FDA any Competent Authority relating to Regulatory to, Governmental Approval of the Product in the Field in the Territoryany Licensed Product. The Parties shall cooperate in good faith with respect to the conduct of any inspections by the FDA or equivalent foreign any regulatory authority of a Party’s site and facilities related to the any Licensed Product. To the extent either Party receives any material written or material oral communication from the FDA or equivalent foreign regulatory authority any other Competent Authority relating to the Regulatory any Governmental Approval process with respect to the Product in the Field in the Territoryany Licensed Product, the Party receiving such communication shall promptly notify the other Party and provide a copy of such any written communication and/or a written summary of such oral communication as soon as reasonably practicable. (iii) If “ONCONASE®” is not approved by the FDA as the Product Trade Name, Alfacell shall not submit any other Trade Name(s) for the Product for approval by the FDA unless such other Trade Name(s) has (have) been mutually agreed by the Parties. Subject to the license rights granted herein, Alfacell shall own all right, title, and interest to ONCONASE and all such Trade Names and intellectual property rights related thereto (including trademark and copyright), and Par shall (A) assign any right, title, and interest it has in any Trade Names (including intellectual property rights related thereto (including trademark and copyright)) to Alfacell, free and clear of all liens, claims, and encumbrances, and (B) take any and all actions reasonably requested by Alfacell in furtherance of the foregoing. *** related to the choosing of any new Trade Name for the Product in the Field in the Territory, including any market research studies conducted by Par pertaining to ONCONASE or any new proposed Trade Name(s) for the Product. Confidential information omitted and filed with the Securities and Exchange Commission. Asterisks denote such omission.