Common use of Regulatory Materials Clause in Contracts

Regulatory Materials. (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.

Regulatory Materials. (a) On a Program-by-Program basisSubject to the Development Plan, commencing on and the Effective Date until terms of this Agreement, Amylin shall assume sole right and principal responsibility for the Regulatory Transfer Datepreparation, Prothena shall have the rightsubmission, in consultation with Celgene, to prepare, file and maintain all maintenance of Regulatory Materials (including any Regulatory Approvalsincluding, without limitation, NDAs) necessary 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 Manufacture shall include responsibility for seeking any necessary approvals of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with 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 Development Product. The Party with the lead regulatory responsibility in a country in the Territory shall be referred to as the "Regulatory Lead" and Manufacture 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 Collaboration Candidates and Collaboration Products proposed NDA filing for such Programjurisdiction 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. Prothena (it being understood that Lilly will review such proposed NDA and provide Celgene with a reasonable opportunity to comment substantively on all material 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 filing or taking material actionits 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 reasonably review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith consider any comments and actions recommended or suggested made by Celgene, including with respect to filing strategythe other. In additionorder for each Party to meet the foregoing responsibilities, Prothena the Regulatory Lead will allow Celgene 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 its representative Control and have the right to attend any and all meetings with Regulatory Authorities require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program necessary to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, obtain and maintain such Program Marketing Approvals in its Regulatory Materials, and to interact with 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 Development and, as applicable, Manufacture Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such Collaboration Candidates label, labeling, package inserts and Collaboration Products packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for such Program 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 terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applyCommercialization Plan.

Regulatory Materials. (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena Alvogen shall have the rightsole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the 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 Celgenethe Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to prepareProduct in the Territory. In all cases, file and maintain all prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, 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 Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategythe Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory 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. In additionAlvogen shall consider all such comments in good faith. Alvogen shall, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited 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 limited initiated by such 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 AuthorityAgencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable. (b) If Celgene exercises To the extent permitted by Applicable Law and necessary or useful to maintain the MAA Approval or other Regulatory Approval (including, in each case, any supplement thereto) for Product in the Territory, Alvogen shall have a right to refer to and use in any filing with respect to the MAA Approval for Product or other Regulatory Approval in the Territory at Alvogen’s own expense, all (i) regulatory filings (including the MAA), (ii) MAA Approval, and (iii) documents, information and data contained in such filings or approvals, which Pfenex has used or filed with or produced to any Regulatory Agency with respect to Product or the Pfenex Technology. Pfenex shall submit and file with the Regulatory Agencies in the Territory all documents necessary or advisable to grant to Alvogen such rights to such filings, approvals, documents, information or data, subject in each case to the requirements and restrictions of the applicable Regulatory Agencies. Alvogen may sublicense the right of reference set forth in this Section 3.4(b) to its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND Sublicensees for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program Territory in accordance with Section 2.2. (c) To the terms extent permitted by Applicable Law and conditions necessary or useful to obtain or maintain any marketing or other approval or for the filing of Section 2.5. Additionallyany Regulatory Materials for Product for the development, manufacture, or Commercialization of Product outside the Territory at Pfenex’s own expense, Pfenex shall have a right to refer to and use in filing for such approvals with Regulatory Agencies outside the Territory, all (i) Regulatory Materials (including the MAA), (ii) MAA Approval and other Regulatory Approvals in the Territory, and (iii) documents, information and data contained in such filings or approvals, which Alvogen has used or filed with or produced to the applicable Regulatory Agencies with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant Product or the Pfenex Technology. Alvogen shall submit and file with the applicable Regulatory Agency all documents necessary or advisable to Section 2.5grant to Pfenex such rights to such materials, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing filings, approvals, documents, information or taking material actiondata, and will reasonably and subject in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities each case to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration requirements and restrictions of the Option Term for such Programapplicable Regulatory Agency. Pfenex may sublicense the right of reference set forth in this [***]Certain confidential information contained in this document, Section 2.6.1(amarked by brackets, has been omitted because it is both (i) not material and (and not this Section 2.6.1(b)ii) shall applywould be competitively harmful if publicly disclosed.

Regulatory Materials. (a) On a Subject to Section 2.3, and subject further to Section 2.6.1(b) of the Master Collaboration Agreement with respect to the Licensed Program-by-Program basis, commencing on the Effective Date until the Regulatory end of the Phase 1 Option Term for the Licensed Program (the “Transfer Date”), Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Licensed Program Antibodies and/or Licensed Program Products for such Program (collectively, in the “Program Regulatory Materials”)Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Licensed Program Antibodies and/or Licensed Program Products for such Programin the Territory hereunder. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given ProgramSubject to Section 2.3, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, file and maintain such all Regulatory Materials (including any Regulatory Approvals) necessary for the Development, Manufacture and Commercialization of any Licensed Program Regulatory MaterialsAntibodies and/or Licensed Program Products in the Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and, as applicableDevelopment, Manufacture and Commercialization of such Collaboration Candidates and Collaboration any Licensed Program Antibodies and/or Licensed Program Products for such Program in accordance with the terms and conditions of Section 2.5Territory hereunder. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials, but only if such Regulatory Materials directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Territory, prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities with respect to Licensed Program Antibodies and/ or Licensed Program Products in the Territory to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, but only if such meeting directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applyTerritory.

Regulatory Materials. (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena Alvogen shall have the rightsole right to control filing or submission of Regulatory Materials with the FDA with respect to Product including the NDA for Product, subject to ‎Section 3.2 and in consultation with Celgenethe Executive Steering Committee, and shall be responsible for managing all communications and interactions with the FDA with respect to prepareProduct in the Territory. In either case, file and maintain all prior to the filing of any Regulatory Materials (including the NDA) for Product with the FDA, Alvogen shall provide a copy thereof to NRx (through the Executive Steering Committee) for its review and comment. NRx shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategythe Product to provide Alvogen 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 which case NRx shall have as much time as is reasonably practicable to provide Alvogen with comments. In additionAlvogen shall consider all such comments in good faith. Alvogen shall, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited permitted by Applicable Law and to the extent reasonably practicable, provide NRx 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 limited initiated by such Regulatory Authorityor on behalf of Alvogen or its Affiliates, (ii) an opportunity to have up to two representative attend (solely as a non-participating observer) all substantive meetings with the FDA with respect to Product, and in any case keep NRx informed as to all material interactions with the FDA with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the FDA with respect to Product as soon as reasonably practicable. (b) If Celgene exercises its Phase 1 Portion Participation Right To the extent permitted by Applicable Law and necessary or useful to obtain or maintain the NDA Approval (including any supplement thereto) or any Regulatory Approval, or for a given Program, then immediately after such exercise, Prothena shall initiate the transfer filing of all Program any Regulatory Materials, including for clarity Product in the Field in the Territory, NRx hereby grants to Alvogen the right to access, reference and use in any IND filing with respect to the NDA Approval or any other Regulatory Approval for Product in the relevant Collaboration Candidates and/or Collaboration Products that are Field to the subject of such Program to Celgene. The date on which such Program FDA or other applicable Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. ThereafterAgency, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program all (i) Regulatory Materials, and (ii) documents, information and data contained in such filings or approvals, which NRx has used or filed with or produced to interact the FDA with respect to Product or the NRx Technology. NRx shall submit and file with the FDA or such applicable Regulatory Agency all documents necessary or advisable to grant to Alvogen such rights to such filings, approvals, documents, information or data, subject in each case to the requirements and restrictions of the FDA. Alvogen may sublicense the right of access, reference, and use as set forth in this ‎Section 3.4(b) to its sublicensees for the Territory in accordance with ‎Section 2.2. (c) To the extent permitted by Applicable Law and necessary or useful to obtain or maintain any marketing or other approval or for the filing of any Regulatory Materials for Product for the development, manufacture, or Commercialization of Product in the Field outside the Territory (solely with respect to such countries in which NRx has the rights to develop, manufacture, have manufactured, or Commercialize Product in the Field pursuant to ‎Section 3.2(e)), Alvogen hereby grants to NRx the right to access, reference and use in filing for such approvals with Regulatory Authorities Agencies outside the Territory or for any new products (other than Products or Competing Products) within the Territory in the Field, all (i) Regulatory Materials (including the NDA), (ii) NDA Approval, and (iii) documents, information and data contained in such filings or approvals, which Alvogen has used or filed with or produced to the FDA with respect to Product or the NRx Technology. Alvogen shall submit and file with the applicable Regulatory Agency all documents necessary or advisable to grant to NRx such rights to such materials, filings, approvals, documents, information or data, subject in each case to the requirements and restrictions of the applicable Regulatory Agency. NRx may sublicense the right of reference set forth in this ‎Section 3.4(c) to its licensees solely for use in connection with the Development anddevelopment, as applicablemanufacture, Manufacture or Commercialization of such Collaboration Candidates and Collaboration Products for such Program in accordance with Product outside the terms and conditions of Section 2.5. Additionally, Territory (solely with respect to any Phase 1 Clinical Trial conducted by Celgene such countries in which NRx has the rights to develop, manufacture, have manufactured, or Commercialize Product pursuant to Section 2.5‎Section 3.2(e)) or any new products (other than the Product or Competing Products) within the Territory in the Field. (d) Each Party disclaims any representation or warranty that any filings, Celgene will approvals, documents, information or data provided as set forth in this ‎Section 3.4 shall meet the requirements of any particular country, or that such filings, approvals, documents, information or data shall be adequate or usable by the other Party in connection with seeking any marketing authorization for Product in any particular country. (e) Each Party (the “Assisting Party”) shall cooperate and provide Prothena the other Party with a reasonable opportunity assistance in connection with the exercise by the other Party of its rights and performance by the other Party of its obligations under this ‎ARTICLE III and, in connection therewith, the Assisting Party shall provide to comment substantively the other Party all Product dossiers and other information that are in the Assisting Party’s possession or control (in such form as maintained by or on all material Program Regulatory Materials prior to filing or taking material actionbehalf of the Assisting Party in the ordinary course of business, and will without obligation to provide any translations) and reasonably and in good faith consider any comments and actions recommended requested by Prothena, including the Other Party for purposes of performing such obligations or exercising such rights with respect to filing strategy. In additionthe Product, with respect and the other Party shall be entitled to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any use such dossiers and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term other information for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applypurpose.

Regulatory Materials. (a) On a Subject to Section 2.3, and subject further to Section 2.6.1(b) of the Master Collaboration Agreement with respect to the Licensed Program-by-Program basis, commencing on the Effective Date until the Regulatory end of the Phase 1 Option Term for the Licensed Program (the “Transfer Date”), Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Licensed Program Antibodies and/or Licensed Program Products for such Program (collectively, in the “Program Regulatory Materials”)Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Licensed Program Antibodies and/or Licensed Program Products for such Programin the Territory hereunder. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given ProgramSubject to Section 2.3, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, file and maintain such all Regulatory Materials (including any Regulatory Approvals) necessary for the Development, Manufacture and Commercialization of any Licensed Program Regulatory MaterialsAntibodies and/or Licensed Program Products in the Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and, as applicableDevelopment, Manufacture and Commercialization of such Collaboration Candidates and Collaboration any Licensed Program Antibodies and/or Licensed Program Products for such Program in accordance with the terms and conditions of Section 2.5Territory hereunder. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials, but only if such Regulatory Materials directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Territory, prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities with respect to Licensed Program Antibodies and/or Licensed Program Products in the Territory to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, but only if such meeting directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applyTerritory.

Regulatory Materials. Licensee shall, as instructed by Licensor, either (ai) On a Program-by-Program basisif applicable and if permitted by Applicable Laws, commencing on 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 Effective Date until Product(s), (ii) terminate or withdraw any Regulatory Materials, including Regulatory Approval that is Controlled by Licensee or its or Designated Party with respect to the Regulatory Transfer DateProduct(s), Prothena shall have the right, in consultation with Celgene, and/or (iii) continue to prepare, file and maintain all hold any such Regulatory Materials (including any Regulatory Approval) for the sole benefit of Licensor or its designee, in each case in accordance with Applicable Laws. Prior to the effective date of termination and thereafter, Licensee shall, as instructed by Licensor, take all action necessary to, and shall use all reasonable efforts to, transfer, terminate or withdraw (as the case may be) all such Regulatory Materials (including Regulatory Approvals) necessary 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, then, at Licensor’s request, Licensee shall continue to hold such Regulatory Materials (including Regulatory Approval) for the Development and Manufacture sole benefit of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”)Licensor or its designee, and to interact with Regulatory Authorities in connection shall appoint Licensor or its designee as its exclusive distributor (with the Development right to subcontract and Manufacture of any Collaboration Candidates appoint subdistributors) under such Regulatory Approval for the Product in the Territory and Collaboration Products for such Program. Prothena will provide Celgene also as its agent to communicate with a reasonable opportunity to comment substantively on all material the applicable Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including Authority with respect to filing strategy. In additionsuch Regulatory Materials, Prothena will allow Celgene until such time Licensor or its representative to attend any designee files its own Regulatory Materials and obtain its own Regulatory Approval for the Product in the Territory. Licensee may retain copies of all meetings with Regulatory Authorities Materials to the extent such attendance is not prohibited required by Applicable Laws or limited by such Regulatory Authority. (b) If Celgene exercises for so long as may be required for Licensee to perform any of its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgenesurviving obligations under this Agreement. The date on which such Program All Regulatory Materials are transferred subject to Celgene this Article 13.7.2(a) shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with ProthenaConfidential Information of Licensor and, to prepare, file, and maintain the extent Licensee retains such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program Materials in accordance with the terms this Article 13.7.2(a), Licensee shall be subject to and conditions of Section 2.5. Additionally, shall comply with Article 12 with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applyMaterials.

Regulatory Materials. (ai) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena BeiGene shall have the rightsole right and responsibility for preparing and submitting all Regulatory Materials for Compounds and Products in the Field in the Territory, in consultation including preparing, submitting and holding all INDs and XXXx for Compounds and Products, with Celgenethe exception of the CMC sections of Regulatory Materials containing Confidential CMC Information or any DMF owned by Ambrx. (ii) If not previously prepared and filed, to Ambrx will, at BeiGene’s request, prepare, file and maintain with all applicable Regulatory Materials (including any Regulatory Approvals) necessary Authorities a DMF for the Development Compounds and Manufacture Products in the Field in the Territory and, subject to the remainder of any Collaboration Candidates this Section 4.6, Ambrx shall also provide such other information and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities assistance as BeiGene may reasonably request in connection with the Development completion of and Manufacture submission of any Collaboration Candidates and Collaboration Products applications for Regulatory Approvals for such Compounds and Products and the maintenance thereof. BeiGene and its Affiliates and Sublicensees may refer to such DMF in any filing made in connection with obtaining or maintaining a Regulatory Approval for a Product and Ambrx hereby grants such a Right of Reference to such DMF. Ambrx will be responsible for assuring that during the Term of this Agreement with respect to a given Licensed Program, such DMF will be in the form appropriate for filing with all applicable Regulatory Authorities, including those in each Major Market Country and such other countries as requested by BeiGene, and such DMF shall be maintained in full force and effect by Ambrx during the Term and will not be amended without the consent of BeiGene, such consent not to be unreasonably withheld, other than with respect to amendments that are required by Applicable Law or a Regulatory Authority. Prothena will Ambrx will, on written request by BeiGene or its Affiliate or Sublicensee, provide Celgene with to the requesting party, and to any specified Regulatory Authority, a reasonable opportunity letter, in the form reasonably required by the requesting party, acknowledging that the requesting party has a Right of Reference to comment substantively on any such DMF. If Ambrx has not filed a DMF in any jurisdiction (including if the Regulatory Authority in a given jurisdiction does not accept a DMF) or has not or cannot give BeiGene, its Affiliate or Sublicensee a right of access to the DMF, or the information contained within the DMF is not sufficient to address questions or requests for information from Regulatory Authorities, then any and all material Ambrx IP or Ambrx Technology Platform IP required to be included in any Regulatory Material (including any additional data, including raw data when required), the relevant section of the Regulatory Materials prior shall be prepared by Ambrx and submitted to filing the applicable Regulatory Authorities directly; provided that if Ambrx is not permitted to prepare or taking material actionsubmit the relevant section of the Regulatory Materials to the applicable Regulatory Authorities directly, then the Parties shall promptly (and will reasonably and in any event within [***] ([***]) [***]) meet in good faith consider any comments and actions recommended by Celgene, including with respect reasonably agree to filing strategy. In addition, Prothena will allow Celgene a solution to enable the Parties to prepare or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for submit the relevant Collaboration Candidates and/or Collaboration Products that are section of the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applysoon as practicable.

Regulatory Materials. (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena CASI shall have the right, in consultation with Celgene, to prepare, file prepare and maintain submit all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture Licensed Product in the Territory. CASI shall timely notify Cleave of any Collaboration Candidates and Collaboration Products for such Program (collectively, all material Regulatory Communications in English that are related to the “Program Regulatory Materials”)Licensed Product in the Territory, and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with give Cleave a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, review and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategycomment. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. AdditionallyMoreover, with respect to submission of (a) an NDA in the Territory, CASI will provide Cleave with drafts of such filing in the language such filing is drafted and a 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 (b) other material Regulatory Materials to any Phase 1 Clinical Trial conducted 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 (which 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, taking into account the best interests of the Development and/or Commercialization of the Licensed Product. If requested by Celgene pursuant Cleave (no more frequently than once every [***]), CASI 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 subject to Section 2.54.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program reasonably assist CASI in seeking and obtaining Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including Approvals with respect to filing strategythe Licensed Product in the Territory. In additionNotwithstanding the foregoing, the day-to-day functional teams of the Parties may agree to other procedures for notifications, English summaries and translations, and commenting in respect of meetings, submissions, filings with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5Regulatory Authority and notices, Celgene will allow Prothena correspondences, communications or its representative to attend other filings received from any and all meetings with Regulatory Authorities Authority that are related to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if Licensed Product in the Regulatory Transfer Date does not occur prior Territory in order to facilitate the expiration day-to-day work of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applyfunctional teams of the Parties.

Regulatory Materials. (a) On a Subject to Section 2.3, and subject further to Section 2.6.1(b) of the Master Collaboration Agreement with respect to the Licensed Program-by-Program basis, commencing on the Effective Date until the Regulatory end of the Phase 1 Option Term for the Licensed Program (the “Transfer Date”), Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Licensed Program Antibodies and/or Licensed Program Products for such Program (collectively, in the “Program Regulatory Materials”)Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Licensed Program Antibodies and/or Licensed Program Products for such Programin the Territory hereunder. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given ProgramSubject to Section 2.3, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, file and maintain such all Regulatory Materials (including any Regulatory Approvals) necessary for the Development, Manufacture and Commercialization of any Licensed Program Regulatory MaterialsAntibodies and/or Licensed Program Products in the Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and, as applicableDevelopment, Manufacture and Commercialization of such Collaboration Candidates and Collaboration any Licensed Program Antibodies and/or Licensed Program Products for such Program in accordance with the terms and conditions of Section 2.5Territory hereunder. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials, but only if such Regulatory Materials directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Territory, prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities with respect to Licensed Program Antibodies and/or Licensed Program Products in the Territory to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, but only if such meeting directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applyTerritory.

Regulatory Materials. Betta shall apply for and maintain, at Betta’s sole cost and expense, all Regulatory Materials relating to the Licensed Products in the Field in the Territory. All Regulatory Materials relating to the Licensed Products in the Field in the Territory shall be 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 be filed in EyePoint’s name, which Regulatory Materials will be owned by EyePoint, but shall be prepared, filed and maintained by Betta on EyePoint’s behalf (asuch 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 Field in the Territory, both prior to and subsequent to receipt of any Regulatory Approvals. At least thirty (30) On days in advance of filing any material Regulatory Document relating to a ProgramLicensed Product with any Regulatory Authority in the Territory, including any IND or MAA (or, if a Regulatory Authority requires that a filing be made in a period that does not allow for such thirty (30) day advance review period, then at a mutually agreed upon time in advance of such filing), Betta shall provide to EyePoint for EyePoint’s review and comment the then-by-Program basiscurrent draft of such Regulatory Document in full in Chinese and an English translation thereof. Betta will consider in good faith EyePoint’s comments to any material Regulatory Materials relating to a Licensed Product prior to filing such Regulatory Materials with the applicable Regulatory Authorities; provided, commencing on that no EyePoint Territory Regulatory Document relating to a Licensed Product may be filed in the Effective Date until 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 Transfer DateAuthorities in the Territory relating to the Licensed Products, Prothena and EyePoint shall have the right, in consultation with Celgenebut not the obligation, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for have a representative of EyePoint accompany Betta to each such meeting in an observational capacity if such attendance is permitted by the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with applicable Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material actionTerritory; provided, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionallythat, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings meeting with Regulatory Authorities in the Territory pertaining to an EyePoint Territory Regulatory Document, EyePoint’s representative shall have the extent right to attend such attendance is not prohibited or limited by meeting as a representative of the applicant/owner of such EyePoint Territory Regulatory Authority. For clarityDocument, if the Regulatory Transfer Date does not occur unless EyePoint agrees in writing prior to such meeting that such representative shall be in attendance in an observational capacity only. If a Regulatory Authority requires EyePoint to execute any document or attend any meeting, as for example as the expiration applicant/owner of an EyePoint Territory Regulatory Document, then EyePoint will promptly provide Betta with the Option Term for such Programnecessary support at the expense of Betta. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Section 2.6.1(aMARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (and not this Section 2.6.1(b)II) shall applyIS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

Regulatory Materials. (a) On a Program-by-Program basisPrior to the Transfer Notice, commencing on the Effective Date until the Regulatory Transfer Date, Prothena Pfenex shall have the rightsole right to control filing or submission of Regulatory Materials to the FDA with respect to the Product including the NDA for Product, subject to Section 3.1 and the oversight of and in consultation with Celgenethe Executive Steering Committee, and shall be responsible for managing all communications and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to preparethe omitted portions. interactions with the FDA with respect to Product in the Territory. From and after the Transfer Notice, file Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the FDA with respect to Product including the NDA Approval for Product, subject to Section 3.2 and maintain 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 (including any Regulatory Approvalsthe NDA) necessary for Product with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program FDA, the filing Party (collectivelythe “Filing Party”) shall provide a copy thereof to the other Party (through the Executive Steering Committee, the “Program Regulatory MaterialsReviewing Party”), ) for its review and to interact with Regulatory Authorities in connection with comment. The Reviewing Party shall have fifteen (15) Business Days from the Development and Manufacture date it receives a copy of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategythe 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 which case the Reviewing Party shall have as much time as is reasonably practicable to provide the Filing Party with comments. In additionThe Filing Party shall consider all such comments in good faith. The Filing Party shall, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited permitted by Applicable Law, provide the Reviewing Party 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 limited initiated by such Regulatory Authorityor 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 all substantive meetings with the FDA with respect to Product, and in any case keep the Reviewing Party informed as to all material interactions with the FDA with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the FDA with respect to Product as soon as reasonably practicable. (b) If Celgene exercises To the extent permitted by Applicable Law and necessary or useful to maintain the NDA Approval (including any supplement thereto) for Product in the Territory, Alvogen shall have a right to refer to and use in any filing with respect to the NDA Approval for Product to the FDA, all (i) regulatory filings (including the NDA), (ii) NDA Approval, and (iii) documents, information and data contained in such filings or approvals, which Pfenex has used or filed with or produced to the FDA with respect to Product or the Pfenex Technology. Pfenex shall submit and file with the FDA all documents necessary or advisable to grant to Alvogen such rights to such filings, approvals, documents, information or data, subject in each case to the requirements and restrictions of the FDA. Alvogen may sublicense the right of reference set forth in this Section 3.4(b) to its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND sublicensees for the relevant Collaboration Candidates and/or Collaboration Products that are Territory in accordance with Section 2.2. (c) To the subject extent permitted by Applicable Law and necessary or useful to obtain or maintain any marketing or other approval or for the filing of such Program to Celgene. The date on which such Program any Regulatory Materials are transferred for Product for the development, manufacture, or Commercialization of Product outside the Territory, Pfenex shall have a right to Celgene shall be the “Regulatory Transfer Date” refer to and use in filing for such Program. Thereafterapprovals with Regulatory Agencies outside the Territory, Celgene shall have all (i) Regulatory Materials (including the rightNDA), in consultation with Prothena, to prepare, file(ii) NDA Approval, and maintain (iii) documents, information and data contained in such Program filings or approvals, which Alvogen has used or filed with or produced to the FDA with respect to Product or the Pfenex Technology. Alvogen shall submit and file with the applicable Regulatory MaterialsAgency all documents necessary or advisable to grant to Pfenex such rights to such materials, filings, [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to interact with the omitted portions. approvals, documents, information or data, subject in each case to the requirements and restrictions of the applicable Regulatory Authorities Agency. Pfenex may sublicense the right of reference set forth in this Section 3.4(c) to its licensees solely for use in connection with the Development development, manufacture, or Commercialization of Product outside the Territory. (d) Each Party disclaims any representation or warranty that any filings, approvals, documents, information or data provided as set forth in this Section 3.4 shall meet the requirements of any particular country, or that such filings, approvals, documents, information or data shall be adequate or usable by the other Party in connection with seeking any marketing authorization for Product in any particular country. (e) Each Party (the “Assisting Party”) shall cooperate and provide the other Party with reasonable assistance in connection with the exercise by the other Party of its rights and performance by the other Party of its obligations under this Article III and, in connection therewith, the Assisting Party shall provide to the other Party all Product dossiers and other information that are in the Assisting Party’s possession or control (in such form as applicablemaintained by or on behalf of the Assisting Party in the ordinary course of business, Manufacture and without obligation to provide any translations) and reasonably requested by the Other Party for purposes of performing such Collaboration Candidates and Collaboration Products for obligations or exercising such Program in accordance with the terms and conditions of Section 2.5. Additionally, rights with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material actionthe Product, and will reasonably the other Party shall be entitled to use such dossiers and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term other information for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applypurpose.

Regulatory Materials. (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena Alvogen shall have the rightsole right to control filing or submission of Regulatory Materials with the EMA and other Regulatory Agencies in the 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 Celgenethe Executive Steering Committee, and shall be responsible for managing all communications and interactions with the EMA and other Regulatory Agencies in the Territory with respect to prepareProduct in the Territory. In all cases, file and maintain all prior to the filing of any Regulatory Materials (including the MAA for Product) for [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) 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 Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategythe Product to provide Alvogen with comments regarding such Regulatory Materials, unless the EMA and other Regulatory Agencies in the Territory 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. In additionAlvogen shall consider all such comments in good faith. Alvogen shall, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited 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 limited initiated by such 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 EMA and other Regulatory AuthorityAgencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the EMA and other Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any 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 practicable. (b) If Celgene exercises To the extent permitted by Applicable Law and necessary or useful to maintain the MAA Approval or other Regulatory Approval (including, in each case, any supplement thereto) for Product in the Territory, Alvogen shall have a right to refer to and use in any filing with respect to the MAA Approval for Product or other Regulatory Approval in the Territory, all (i) regulatory filings (including the MAA), (ii) MAA Approval, and (iii) documents, information and data contained in such filings or approvals, which Pfenex has used or filed with or produced to the EMA or FDA with respect to Product or the Pfenex Technology. Pfenex shall submit and file with the EMA or other Regulatory Agencies in the Territory all documents necessary or advisable to grant to Alvogen such rights to such filings, approvals, documents, information or data, subject in each case to the requirements and restrictions of the EMA or FDA. Alvogen may sublicense the right of reference set forth in this Section 3.4(b) to its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND Sublicensees for the relevant Collaboration Candidates and/or Collaboration Products that are Territory in accordance with Section 2.2. (c) To the subject extent permitted by Applicable Law and necessary or useful to obtain or maintain any marketing or other approval or for the filing of such Program to Celgene. The date on which such Program any Regulatory Materials are transferred for Product for the development, manufacture, or Commercialization of Product outside the Territory, Pfenex shall have a right to Celgene shall be the “Regulatory Transfer Date” refer to and use in filing for such Program. Thereafterapprovals with Regulatory Agencies outside the Territory, Celgene shall have all (i) Regulatory Materials (including the rightMAA), (ii) MAA Approval and other Regulatory Approvals in consultation with Prothena, to prepare, filethe Territory, and maintain (iii) documents, information and data contained in such Program filings or approvals, which Alvogen has used or filed with or produced to the EMA with respect to Product or the Pfenex Technology. Alvogen shall submit and file with the applicable Regulatory MaterialsAgency all documents necessary or advisable to grant to Pfenex such rights to such materials, filings, approvals, documents, information or data, subject in each case to the requirements and restrictions of the applicable Regulatory Agency. Pfenex may sublicense the right of reference set forth in this Section 3.4(c) to interact with Regulatory Authorities its licensees solely for use in connection with the Development development, manufacture, or Commercialization of Product outside the Territory. [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. (d) Each Party disclaims any representation or warranty that any filings, approvals, documents, information or data provided as set forth in this Section 3.4 shall meet the requirements of any particular country, or that such filings, approvals, documents, information or data shall be adequate or usable by the other Party in connection with seeking any marketing authorization for Product in any particular country. (e) Each Party (the “Assisting Party”) shall cooperate and provide the other Party with reasonable assistance in connection with the exercise by the other Party of its rights and performance by the other Party of its obligations under this Article III and, in connection therewith, the Assisting Party shall provide to the other Party all Product dossiers and other information that are in the Assisting Party’s possession or control (in such form as applicablemaintained by or on behalf of the Assisting Party in the ordinary course of business, Manufacture and without obligation to provide any translations) and reasonably requested by the Other Party for purposes of performing such Collaboration Candidates and Collaboration Products for obligations or exercising such Program in accordance with the terms and conditions of Section 2.5. Additionally, rights with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material actionthe Product, and will reasonably the other Party shall be entitled to use such dossiers and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term other information for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applypurpose.

Regulatory Materials. (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena KHK shall have the right, in consultation with Celgene, to prepare, file prepare and maintain submit all Regulatory Materials (including for Products in the Field in 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 Approvals) necessary for the Development Authority and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material notices, correspondences, communications, or other filings received from any Regulatory Materials prior Authority that are related to filing or taking material actionany Product in the Territory. Moreover, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to submission of (i) Marketing Authorization Application in the Territory, KHK will provide MEI with drafts of such filing strategyand 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 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, Prothena will allow Celgene or its representative to attend upon reasonable request by MEI, KHK shall also provide MEI with any and all meetings with Regulatory Authorities Material(s) not previously provided under this Section 5.2 (Regulatory Materials). Upon request by KHK, MEI shall, subject to the extent such attendance is not prohibited or limited by such reasonable availability of MEI’s relevant personnel, assist KHK in seeking and obtaining Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, Approvals with respect to Product in the Territory, including: [*CONFIDENTIAL*] provided, that MEI shall have no obligation under this Section 5.2 (Regulatory Materials) (or under any Phase 1 Clinical Trial conducted by Celgene pursuant other provision of this Agreement) to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including assist KHK with respect to filing strategy. In addition, with respect to regulatory matters in excess of [*CONFIDENTIAL*] and any Phase 1 Clinical Trial conducted such assistance provided by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent MEI in excess of such attendance is not prohibited or limited limit shall be paid for by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration KHK at a rate of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply[*CONFIDENTIAL*] per hour.

Regulatory Materials. (a) On a Subject to Section 2.3, and subject further to Section 2.6.1(b) of the Master Collaboration Agreement with respect to the Licensed Program-by-Program basis, commencing on the Effective Date until the Regulatory end of the Phase 1 Option Term for the Licensed Program (the “Transfer Date”), Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Licensed Program Antibodies and/or Licensed Program Products for such Program (collectively, in the “Program Regulatory Materials”)Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Licensed Program Antibodies and/or Licensed Program Products for such Programin the Territory hereunder. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given ProgramSubject to Section 2.3, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, file and maintain such all Regulatory Materials (including any Regulatory Approvals) necessary for the Development, Manufacture and Commercialization of any Licensed Program Regulatory MaterialsAntibodies and/or Licensed Program Products in the Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and, as applicableDevelopment, Manufacture and Commercialization of such Collaboration Candidates and Collaboration any Licensed Program Antibodies and/or Licensed Program Products for such Program in accordance with the terms and conditions of Section 2.5Territory hereunder. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials, but only if such Regulatory Materials directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Territory, prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities with respect to Licensed Program Antibodies and/or Licensed Program Products in the Territory to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, but only if such meeting directly impacts regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall applyTerritory.