Common use of Regulatory Materials Clause in Contracts

Regulatory Materials. Subject to the Development Plan, and the terms of this Agreement, Amylin shall assume sole right and principal responsibility for the preparation, submission, and maintenance of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Products in the U.S., and Lilly shall assume sole right and principal responsibility for the preparation, submission and maintenance of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Products (i) in each Major Market outside the U.S. and (ii) in each country in the Territory outside of the Major Markets that is determined by the JCC to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts and in compliance with other regulatory obligations related to the conduct of Development of the Product in the applicable jurisdiction(s) and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in the applicable jurisdiction(s) in connection with the Product. The Party with the lead regulatory responsibility in a country in the Territory shall be referred to as the "Regulatory Lead" and the country(ies) in which such Party is the Regulatory Lead shall be referred to as such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products in the U.S. shall be held in Amylin's name and shall be owned solely by Amylin, subject to Lilly's rights under this Agreement and the Related Agreements. Lilly shall consult and cooperate with Amylin in Amylin's preparation of such NDAs and in obtaining Marketing Approvals in the U.S. Amylin agrees to consult with Lilly regarding, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Amylin is responsible. Additionally, Amylin shall provide Lilly with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Lilly shall have the right to review such proposed NDA and provide its comments to Amylin within sixty (60) days of the delivery of such proposed NDA to Lilly. (it being understood that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products outside the U.S. shall be held in Lilly's name and be owned solely by Lilly, subject to Amylin's rights under this Agreement and the Related Agreements. Amylin shall consult and cooperate with Lilly in Lilly's preparation of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, the Regulatory Lead will have the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent necessary to obtain and maintain Marketing Approvals in its Regulatory Jurisdiction; (iii) seek and/or obtain any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to a Regulatory Authority and determine, with the input and advice of the other Party, whether the Regulatory Material meets the regulatory standards, and is consistent with the regulatory strategy of the Parties. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s), unless in accordance with the Commercialization Plan.

Regulatory Materials. Subject to (a) Alvogen shall have the Development Plan, and the terms of this Agreement, Amylin shall assume sole right and principal responsibility for the preparation, submission, and maintenance to control filing or submission of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Products the Regulatory Agencies in the U.S.Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and Lilly shall assume sole right and principal responsibility for the preparation[***]Certain confidential information contained in this document, submission and maintenance of Regulatory Materials (includingmarked by brackets, without limitation, NDAs) and for seeking Marketing Approval in connection with Products has been omitted because it is both (i) in each Major Market outside the U.S. not material and (ii) in each country would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory outside of the Major Markets that is determined by the JCC with respect to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts and in compliance with other regulatory obligations related to the conduct of Development of the Product in the applicable jurisdiction(sTerritory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in Product with the applicable jurisdiction(sRegulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) in connection for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product. The Party Product to provide Alvogen with comments regarding such Regulatory Materials, unless the lead regulatory responsibility in a country Regulatory Agencies in the Territory shall or Applicable Law requires that such Regulatory Material(s) be referred to as the "Regulatory Lead" and the country(ies) filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such Party is comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Lead shall be referred to as such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products Agencies in the U.S. shall be held in Amylin's name and shall be owned solely by AmylinTerritory with respect to Product, subject to Lilly's rights under this Agreement and the Related Agreements. Lilly shall consult and cooperate with Amylin in Amylin's preparation of such NDAs and in obtaining Marketing Approvals any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the U.S. Amylin agrees Territory with respect to consult with Lilly regardingProduct, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Amylin is responsible. Additionally, Amylin shall provide Lilly with the then most current (iii) a copy of any proposed NDA filing for such jurisdiction reasonably (material documents, information and in any event at least ninety (90) days) prior correspondence submitted to its anticipated submission to the applicable Regulatory Authority, and Lilly shall have the right to review such proposed NDA and provide its comments to Amylin within sixty (60) days of the delivery of such proposed NDA to Lilly. (it being understood that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products outside the U.S. shall be held in Lilly's name and be owned solely by Lilly, subject to Amylin's rights under this Agreement and the Related Agreements. Amylin shall consult and cooperate with Lilly in Lilly's preparation of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, received from the Regulatory Lead will have Agencies in the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access Territory with respect to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent necessary to obtain and maintain Marketing Approvals in its Regulatory Jurisdiction; (iii) seek and/or obtain any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to a Regulatory Authority and determine, with the input and advice of the other Party, whether the Regulatory Material meets the regulatory standards, and is consistent with the regulatory strategy of the Parties. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s), unless in accordance with the Commercialization Planas soon as reasonably practicable.

Regulatory Materials. Subject Betta shall apply for and maintain, at Betta’s sole cost and expense, all Regulatory Materials relating to the Development Plan, and the terms of this Agreement, Amylin shall assume sole right and principal responsibility for the preparation, submission, and maintenance of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Licensed Products in the U.S., and Lilly shall assume sole right and principal responsibility for Field in the preparation, submission and maintenance of Territory. All Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with relating to the Licensed Products (i) in each Major Market outside the U.S. and (ii) in each country in the Territory outside of the Major Markets that is determined by the JCC to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts and in compliance with other regulatory obligations related to the conduct of Development of the Product in the applicable jurisdiction(s) and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in the applicable jurisdiction(s) in connection with the Product. The Party with the lead regulatory responsibility in a country Field in the Territory shall be referred owned by Betta and held in Betta’s name, except for any Regulatory Materials, including any IND or Imported Drug License, that are required under Applicable Laws to as the "be filed in EyePoint’s name, which Regulatory Lead" and the country(ies) in which such Party is the Regulatory Lead Materials will be owned by EyePoint, but shall be referred to as prepared, filed and maintained by Betta on EyePoint’s behalf (such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials in EyePoint’s name and owned by EyePoint, the “EyePoint Territory Regulatory Documents”). EyePoint shall, at the direction of and with the assistance of Betta, execute any documentation prepared by Betta necessary to appoint Betta as EyePoint’s local regulatory agent to perform regulatory actions on its behalf in connection with the EyePoint Territory Regulatory Documents. Betta shall be responsible, at Betta’s sole cost and expense, for all communications and interactions with Regulatory Authorities with respect to the Licensed Products in the U.S. shall Field in the Territory, both prior to and subsequent to receipt of any Regulatory Approvals. At least thirty (30) days in advance of filing any material Regulatory Document relating to a Licensed Product with any Regulatory Authority in the Territory, including any IND or MAA (or, if a Regulatory Authority requires that a filing be held made in Amylin's name and shall be owned solely by Amylina period that does not allow for such thirty (30) day advance review period, subject to Lilly's rights under this Agreement and the Related Agreements. Lilly shall consult and cooperate with Amylin then at a mutually agreed upon time in Amylin's preparation advance of such NDAs and in obtaining Marketing Approvals in the U.S. Amylin agrees filing), Betta shall provide to consult with Lilly regarding, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority EyePoint for EyePoint’s review and approval comment the then-current draft of NDA filings for which Amylin is responsiblesuch Regulatory Document in full in Chinese and an English translation thereof. Additionally, Amylin shall provide Lilly with the then most current copy of Betta will consider in good faith EyePoint’s comments to any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) material Regulatory Materials relating to a Licensed Product prior to its anticipated submission to filing such Regulatory Materials with the applicable Regulatory AuthorityAuthorities; provided, that no EyePoint Territory Regulatory Document relating to a Licensed Product may be filed in the Territory without the prior written consent of EyePoint, such consent not to be unreasonably withheld, conditioned or delayed. Betta shall notify EyePoint in writing at least ten (10) Business Days in advance of any material meeting with Regulatory Authorities in the Territory relating to the Licensed Products, and Lilly EyePoint shall have the right, but not the obligation, to have a representative of EyePoint accompany Betta to each such meeting in an observational capacity if such attendance is permitted by the applicable Regulatory Authorities in the Territory; provided, that, with respect to any meeting with Regulatory Authorities in the Territory pertaining to an EyePoint Territory Regulatory Document, EyePoint’s representative shall have the right to review attend such proposed NDA and provide its comments to Amylin within sixty (60) days meeting as a representative of the delivery applicant/owner of such proposed NDA EyePoint Territory Regulatory Document, unless EyePoint agrees in writing prior to Lilly. (it being understood such meeting that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products outside the U.S. representative shall be held in Lilly's name and be owned solely by Lilly, subject to Amylin's rights under this Agreement and the Related Agreementsattendance in an observational capacity only. Amylin shall consult and cooperate with Lilly in Lilly's preparation of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, the Regulatory Lead will have the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent necessary to obtain and maintain Marketing Approvals in its Regulatory Jurisdiction; (iii) seek and/or obtain any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to If a Regulatory Authority and determinerequires EyePoint to execute any document or attend any meeting, as for example as the applicant/owner of an EyePoint Territory Regulatory Document, then EyePoint will promptly provide Betta with the input and advice necessary support at the expense of the other PartyBetta. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, whether the Regulatory Material meets the regulatory standardsMARKED BY “[***]”, and is consistent with the regulatory strategy of the PartiesHAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s(b), unless in accordance with the Commercialization Plan.

Regulatory Materials. Subject CASI shall prepare and submit all Regulatory Materials for the Licensed Product in the Territory. CASI shall timely notify Cleave of all material Regulatory Communications in English that are related to the Development PlanLicensed Product in the Territory, and give Cleave a reasonable opportunity to review and comment. Moreover, with respect to submission of (a) an NDA in the terms Territory, CASI will provide Cleave with drafts of this Agreement, Amylin shall assume sole right such filing in the language such filing is drafted and principal responsibility for the preparation, submissiona reasonable English summary of such filing (which summary will include key information) not less than [***] prior to submission so that Cleave may review and comment, and maintenance of (b) other material Regulatory Materials to any Regulatory Authority in the Territory, CASI will provide Cleave with drafts of such submissions in the language such submissions are drafted, and reasonable English summaries of such submissions (includingwhich summaries will include key information) not less than [***] prior to document finalization so that Cleave may review and comment on them. CASI shall consider all comments of Cleave in good faith, without limitationtaking into account the best interests of the Development and/or Commercialization of the Licensed Product. If requested by Cleave (no more frequently than once every [***]), NDAsCASI shall provide Cleave copies of all Regulatory Communications that are not de minimis or non-substantive and that have not been previously provided to Cleave, in the language such Regulatory Communications were made. CASI shall also provide to Cleave copies of the final submitted version of each material Regulatory Material and each granted Regulatory Approval in the Territory. Upon request by CASI, Cleave shall, in accordance with Section 4.1(a) and for subject to Section 4.5, reasonably assist CASI in seeking Marketing Approval in connection and obtaining Regulatory Approvals with Products respect to the Licensed Product in the U.S.Territory. Notwithstanding the foregoing, the day-to-day functional teams of the Parties may agree to other procedures for notifications, English summaries and translations, and Lilly shall assume sole right commenting in respect of meetings, submissions, filings with any Regulatory Authority and principal responsibility for notices, correspondences, communications or other filings received from any Regulatory Authority that are related to the preparation, submission and maintenance of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Products (i) in each Major Market outside the U.S. and (ii) in each country Licensed Product in the Territory outside in order to facilitate the day-to-day work of the Major Markets that is determined by the JCC to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts and in compliance with other regulatory obligations related to the conduct of Development of the Product in the applicable jurisdiction(s) and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in the applicable jurisdiction(s) in connection with the Product. The Party with the lead regulatory responsibility in a country in the Territory shall be referred to as the "Regulatory Lead" and the country(ies) in which such Party is the Regulatory Lead shall be referred to as such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products in the U.S. shall be held in Amylin's name and shall be owned solely by Amylin, subject to Lilly's rights under this Agreement and the Related Agreements. Lilly shall consult and cooperate with Amylin in Amylin's preparation of such NDAs and in obtaining Marketing Approvals in the U.S. Amylin agrees to consult with Lilly regarding, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Amylin is responsible. Additionally, Amylin shall provide Lilly with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Lilly shall have the right to review such proposed NDA and provide its comments to Amylin within sixty (60) days of the delivery of such proposed NDA to Lilly. (it being understood that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products outside the U.S. shall be held in Lilly's name and be owned solely by Lilly, subject to Amylin's rights under this Agreement and the Related Agreements. Amylin shall consult and cooperate with Lilly in Lilly's preparation of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, the Regulatory Lead will have the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent necessary to obtain and maintain Marketing Approvals in its Regulatory Jurisdiction; (iii) seek and/or obtain any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to a Regulatory Authority and determine, with the input and advice of the other Party, whether the Regulatory Material meets the regulatory standards, and is consistent with the regulatory strategy functional teams of the Parties. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s), unless in accordance with the Commercialization Plan.

Regulatory Materials. Subject (a) Prior to the Development PlanTransfer Notice, and Pfenex shall have the terms of this Agreement, Amylin shall assume sole right and principal responsibility for the preparation, submission, and maintenance to control filing or submission of Regulatory Materials (includingto the FDA with respect to the Product including the NDA for Product, without limitationsubject to Section 3.1 and the oversight of and in consultation with the Executive Steering Committee, NDAs) and shall be responsible for seeking Marketing Approval managing all communications and [***] Certain information in connection this document has been omitted and filed separately with Products the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. interactions with the FDA with respect to Product in the U.S.Territory. From and after the Transfer Notice, and Lilly Alvogen shall assume have the sole right and principal responsibility for the preparation, to control filing or submission and maintenance of Regulatory Materials with the FDA with respect to Product including the NDA Approval for Product, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and shall be responsible for managing all communications and interactions with the FDA with respect to Product in the Territory. In either case, prior to the filing of any Regulatory Materials (includingincluding the NDA) for Product with the FDA, without limitationthe filing Party (the “Filing Party”) shall provide a copy thereof to the other Party (through the Executive Steering Committee, NDAsthe “Reviewing Party”) for its review and for seeking Marketing Approval comment. The Reviewing Party shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide the Filing Party with comments regarding such Regulatory Materials, unless the FDA or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in connection which case the Reviewing Party shall have as much time as is reasonably practicable to provide the Filing Party with Products comments. The Filing Party shall consider all such comments in good faith. The Filing Party shall, to the extent permitted by Applicable Law, provide the Reviewing Party with (i) reasonable advanced notice (and in each Major Market outside no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the U.S. and Territory that are either scheduled with or initiated by or on behalf of the Filing Party or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in each country in all substantive meetings with the Territory outside of the Major Markets that is determined by the JCC FDA with respect to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts , and in compliance with other regulatory obligations related any case keep the Reviewing Party informed as to the conduct of Development of the Product in the applicable jurisdiction(s) and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in the applicable jurisdiction(s) in connection all material interactions with the FDA with respect to Product. The Party with the lead regulatory responsibility in a country in the Territory shall be referred to as the "Regulatory Lead" and the country(ies) in which such Party is the Regulatory Lead shall be referred to as such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products in the U.S. shall be held in Amylin's name and shall be owned solely by Amylin, subject to Lilly's rights under this Agreement and the Related Agreements. Lilly shall consult and cooperate with Amylin in Amylin's preparation of such NDAs and in obtaining Marketing Approvals in the U.S. Amylin agrees to consult with Lilly regarding, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Amylin is responsible. Additionally, Amylin shall provide Lilly with the then most current (iii) a copy of any proposed NDA filing for such jurisdiction material documents, information and correspondence submitted to or received from the FDA with respect to Product as soon as reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Lilly shall have the right to review such proposed NDA and provide its comments to Amylin within sixty (60) days of the delivery of such proposed NDA to Lilly. (it being understood that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products outside the U.S. shall be held in Lilly's name and be owned solely by Lilly, subject to Amylin's rights under this Agreement and the Related Agreements. Amylin shall consult and cooperate with Lilly in Lilly's preparation of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, the Regulatory Lead will have the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent necessary to obtain and maintain Marketing Approvals in its Regulatory Jurisdiction; (iii) seek and/or obtain any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to a Regulatory Authority and determine, with the input and advice of the other Party, whether the Regulatory Material meets the regulatory standards, and is consistent with the regulatory strategy of the Parties. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s), unless in accordance with the Commercialization Plan.

Regulatory Materials. Subject to the Development Plan, KHK shall prepare and the terms of this Agreement, Amylin shall assume sole right and principal responsibility for the preparation, submission, and maintenance of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Products in the U.S., and Lilly shall assume sole right and principal responsibility for the preparation, submission and maintenance of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Products (i) in each Major Market outside the U.S. and (ii) in each country in the Territory outside of the Major Markets that is determined by the JCC to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts and in compliance with other regulatory obligations related to the conduct of Development of the Product in the applicable jurisdiction(s) and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in the applicable jurisdiction(s) in connection with the Product. The Party with the lead regulatory responsibility in a country in the Territory shall be referred to as the "Regulatory Lead" and the country(ies) in which such Party is the Regulatory Lead shall be referred to as such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and submit all Regulatory Materials for Products in the U.S. shall be held Field in Amylin's name the Territory and shall own all Regulatory Materials and Regulatory Approvals for Products in the Field in the Territory. KHK shall timely notify MEI of all material submissions, filings with any Regulatory Authority and all material notices, correspondences, A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC. communications, or other filings received from any Regulatory Authority that are related to any Product in the Territory. Moreover, with respect to submission of (i) Marketing Authorization Application in the Territory, KHK will provide MEI with drafts of such filing and a reasonable English summary of such filing (which summary will include key information) not less than [*CONFIDENTIAL*] prior to submission so that MEI may review and comment, and (ii) other Regulatory Materials to the any Regulatory Authority in the Territory, KHK will provide MEI with drafts of such submissions and reasonable English summaries of such submissions (which summaries will include key information) not less than [*CONFIDENTIAL*] prior to document finalization so that MEI may review and comment on them; provided, that any failure by MEI to provide comments within the applicable review period shall not delay KHK’s submission date. KHK shall consider all comments of MEI in good faith, taking into account the best interests of the Development and/or Commercialization of the Product. For clarity, such English summaries to be owned solely provided prior to document submission or finalization, as applicable, shall include [*CONFIDENTIAL*]. KHK shall also provide to MEI copies of the final submitted version of each Regulatory Material and each granted Regulatory Approval in the Territory and an English translation of such Regulatory Approval. In addition, upon reasonable request by AmylinMEI, KHK shall also provide MEI with any Regulatory Material(s) not previously provided under this Section 5.2 (Regulatory Materials). Upon request by KHK, MEI shall, subject to Lilly's rights the reasonable availability of MEI’s relevant personnel, assist KHK in seeking and obtaining Regulatory Approvals with respect to Product in the Territory, including: [*CONFIDENTIAL*] provided, that MEI shall have no obligation under this Agreement Section 5.2 (Regulatory Materials) (or under any other provision of this Agreement) to assist KHK with respect to regulatory matters in excess of [*CONFIDENTIAL*] and the Related Agreements. Lilly shall consult and cooperate with Amylin any such assistance provided by MEI in Amylin's preparation excess of such NDAs and in obtaining Marketing Approvals in the U.S. Amylin agrees to consult with Lilly regarding, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Amylin is responsible. Additionally, Amylin shall provide Lilly with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Lilly shall have the right to review such proposed NDA and provide its comments to Amylin within sixty (60) days of the delivery of such proposed NDA to Lilly. (it being understood that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products outside the U.S. limit shall be held in Lilly's name and be owned solely paid for by Lilly, subject to Amylin's rights under this Agreement and the Related Agreements. Amylin shall consult and cooperate with Lilly in Lilly's preparation KHK at a rate of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, the Regulatory Lead will have the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent necessary to obtain and maintain Marketing Approvals in its Regulatory Jurisdiction; (iii) seek and/or obtain any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to a Regulatory Authority and determine, with the input and advice of the other Party, whether the Regulatory Material meets the regulatory standards, and is consistent with the regulatory strategy of the Parties. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s), unless in accordance with the Commercialization Plan[*CONFIDENTIAL*] per hour.

Regulatory Materials. Subject to (a) Alvogen shall have the Development Plan, and the terms of this Agreement, Amylin shall assume sole right and principal responsibility for the preparation, submission, and maintenance to control filing or submission of Regulatory Materials (including, without limitation, NDAs) with the EMA and for seeking Marketing Approval in connection with Products other Regulatory Agencies in the U.S.Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and Lilly shall assume sole right be responsible for managing all communications and principal responsibility for interactions with the preparationEMA and other Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, submission and maintenance prior to the filing of any Regulatory Materials (includingincluding the MAA for Product) for [***]Certain confidential information contained in this document, without limitationmarked by brackets, NDAs) and for seeking Marketing Approval in connection with Products has been omitted because it is both (i) in each Major Market outside the U.S. not material and (ii) in each country would be competitively harmful if publicly disclosed. Product with the EMA, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the EMA and other Regulatory Agencies in the Territory outside of or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the Major Markets that is determined extent permitted by the JCC to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in compliance no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with other regulatory obligations related to the conduct of Development of the Product in the applicable jurisdiction(s) and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in the applicable jurisdiction(s) in connection with the Product. The Party with the lead regulatory responsibility in a country Agency in the Territory shall be referred that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to as have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the "EMA and other Regulatory Lead" and the country(ies) in which such Party is the Regulatory Lead shall be referred to as such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products Agencies in the U.S. shall be held in Amylin's name and shall be owned solely by AmylinTerritory with respect to Product, subject to Lilly's rights under this Agreement and the Related Agreements. Lilly shall consult and cooperate with Amylin in Amylin's preparation of such NDAs and in obtaining Marketing Approvals any case keep Pfenex informed as to all material interactions with the EMA and other Regulatory Agencies in the U.S. Amylin agrees Territory with respect to consult with Lilly regardingProduct, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Amylin is responsible. Additionally, Amylin shall provide Lilly with the then most current (iii) a copy of any proposed NDA filing for such jurisdiction material documents, information and correspondence submitted to or received from the EMA and other Regulatory Agencies in the Territory with respect to Product as soon as reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Lilly shall have the right to review such proposed NDA and provide its comments to Amylin within sixty (60) days of the delivery of such proposed NDA to Lilly. (it being understood that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products outside the U.S. shall be held in Lilly's name and be owned solely by Lilly, subject to Amylin's rights under this Agreement and the Related Agreements. Amylin shall consult and cooperate with Lilly in Lilly's preparation of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, the Regulatory Lead will have the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent necessary to obtain and maintain Marketing Approvals in its Regulatory Jurisdiction; (iii) seek and/or obtain any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to a Regulatory Authority and determine, with the input and advice of the other Party, whether the Regulatory Material meets the regulatory standards, and is consistent with the regulatory strategy of the Parties. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s), unless in accordance with the Commercialization Plan.

Regulatory Materials. Subject Licensee shall, as instructed by Licensor, either (i) if applicable and if permitted by Applicable Laws, promptly transfer and assign to Licensor or its designee all Regulatory Materials, including each Regulatory Approval that is owned or Controlled by Licensee or its or Designated Party with respect to the Development PlanProduct(s), and (ii) terminate or withdraw any Regulatory Materials, including Regulatory Approval that is Controlled by Licensee or its or Designated Party with respect to the terms of this AgreementProduct(s), Amylin shall assume sole right and principal responsibility for the preparation, submission, and maintenance of and/or (iii) continue to hold any such Regulatory Materials (includingincluding Regulatory Approval) for the sole benefit of Licensor or its designee, without limitationin each case in accordance with Applicable Laws. Prior to the effective date of termination and thereafter, NDAs) and for seeking Marketing Approval in connection with Products in the U.S.Licensee shall, as instructed by Licensor, take all action necessary to, and Lilly shall assume sole right and principal responsibility for use all reasonable efforts to, transfer, terminate or withdraw (as the preparation, submission and maintenance of case may be) all such Regulatory Materials (includingincluding Regulatory Approvals) on or promptly after the effective date of termination. If transfer or assignment of any Regulatory Materials (including Regulatory Approval) to Licensor or its designee is not permitted by Applicable Law, without limitationthen, NDAsat Licensor’s request, Licensee shall continue to hold such Regulatory Materials (including Regulatory Approval) for the sole benefit of Licensor or its designee, and shall appoint Licensor or its designee as its exclusive distributor (with the right to subcontract and appoint subdistributors) under such Regulatory Approval for seeking Marketing Approval in connection with Products (i) in each Major Market outside the U.S. and (ii) in each country in the Territory outside of the Major Markets that is determined by the JCC to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts and in compliance with other regulatory obligations related to the conduct of Development of the Product in the applicable jurisdiction(s) Territory and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials also as its agent to be used in the applicable jurisdiction(s) in connection communicate with the Product. The Party with the lead regulatory responsibility in a country in the Territory shall be referred to as the "Regulatory Lead" and the country(ies) in which such Party is the Regulatory Lead shall be referred to as such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products in the U.S. shall be held in Amylin's name and shall be owned solely by Amylin, subject to Lilly's rights under this Agreement and the Related Agreements. Lilly shall consult and cooperate with Amylin in Amylin's preparation of such NDAs and in obtaining Marketing Approvals in the U.S. Amylin agrees to consult with Lilly regarding, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Amylin is responsible. Additionally, Amylin shall provide Lilly with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory AuthorityAuthority with respect to such Regulatory Materials, and Lilly shall have the right to review until such proposed NDA and provide time Licensor or its comments to Amylin within sixty (60) days of the delivery of such proposed NDA to Lilly. (it being understood that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and designee files its own Regulatory Materials and obtain its own Regulatory Approval for Products outside the U.S. shall be held Product in Lilly's name and be owned solely by Lilly, subject to Amylin's rights under this Agreement and the Related AgreementsTerritory. Amylin shall consult and cooperate with Lilly in Lilly's preparation Licensee may retain copies of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, all Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, the Regulatory Lead will have the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data Materials to the extent necessary required by Applicable Laws or for so long as may be required for Licensee to obtain and maintain Marketing Approvals in perform any of its surviving obligations under this Agreement. All Regulatory Jurisdiction; (iiiMaterials subject to this Article 13.7.2(a) seek and/or obtain any necessary approvals shall be the Confidential Information of Regulatory Authorities for any labelLicensor and, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with extent Licensee retains such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to a Regulatory Authority and determine, with the input and advice of the other Party, whether the Regulatory Material meets the regulatory standards, and is consistent with the regulatory strategy of the Parties. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s), unless in accordance with the Commercialization Planthis Article 13.7.2(a), Licensee shall be subject to and shall comply with Article 12 with respect to such Regulatory Materials.