Common use of Regulatory Responsibilities Clause in Contracts

Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.

Regulatory Responsibilities. 6.6.1 From (a) Merck Serono shall be responsible for notifying the clinical investigative sites and investigators participating in the Existing Clinical Trials (collectively, the “Investigators”) regarding the termination of Merck Serono’s responsibility for the applicable Existing Clinical Trial and the assumption of sponsorship and control of such Existing Clinical Trial by BioMarin. Merck Serono shall be responsible for executing any required amendments or agreements with the Investigators in connection with the foregoing, and will be solely responsible for ensuring that all Existing Clinical Trials are transferred in compliance with all Laws and regulations. (b) Merck Serono shall notify BioMarin of the occurrence and content of any material communication between Merck Serono or any of its Affiliates, on the one hand, and any Government Body (including the EMA or any similar Entity), on the other hand, concerning the Products, the Regulatory Approvals, the Transferred Clinical Trial Authorizations or the Transferred Orphan Designations (including communications relating to the transfer thereof to BioMarin), whether written or oral, as soon as reasonably practicable, but in no event later than three Business Day after the Closingreceipt of such communication, subject and shall promptly provide BioMarin with copies of all written communications and materials related thereto. Merck Serono shall obtain BioMarin’s prior written consent (which shall not be unreasonably withheld, conditioned or delayed) prior to finalizing and making any regulatory filings or submissions to any Governmental Body or providing any response to communications from a Governmental Body relating to the terms of Products, the Transition Services Agreement Regulatory Approvals, the Transferred Clinical Trial Authorizations and except the Transferred Orphan Designations. (c) Except as required by a Party to comply with applicable Law Law, from and after the date that the transfer of a Regulatory Approval, Transferred Clinical Trial Authorization or Transferred Orphan Designation has been legally effected (including through any decision or action of any competent Regulatory Agency), BioMarin shall, with respect to exercise its rights and obligations hereunder each such Regulatory Approval, Transferred Clinical Trial or under any other Ancillary AgreementTransferred Orphan Designation transferred to BioMarin, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product BusinessApprovals, Transferred Clinical Trial Authorizations or Transferred Orphan Designations, and for conducting communications with Governmental Authorities Bodies of competent jurisdiction, for Seller the Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 (d) Subject to the terms provisions of the Transition Services Agreement Safety Data Exchange Agreement, Merck Serono shall, and shall cause its Affiliates to, notify BioMarin of all product complaints received by Merck Serono or its Affiliates relating to the Products. A product complaint received by Merck Serono or its Affiliates which also involves an Adverse Events report shall be reported by Merck Serono or its Affiliates to BioMarin as set forth in the Safety Data Exchange Agreement. Prior to the Transfer Time, Merck Serono shall have all responsibility for required reporting of Adverse Events for the Products in the Territory. On and after the Transfer Time, BioMarin shall have all responsibility for required reporting of Adverse Events for the Products, including in the Territory. BioMarin and Merck Serono shall, and Merck Serono shall cause its Affiliates to, cooperate with each other in connection with any investigation and response to any product complaint. (e) Subject to Section 4.02, Merck Serono and BioMarin shall promptly after the Transfer Time, take all actions required to effect or evidence the change of ownership of any Regulatory Approvals, Transferred Clinical Trial Authorizations and Transferred Orphan Designations from Merck Serono to BioMarin (or an Affiliate or sublicensee of BioMarin). (f) From and after the time at which, on an individual basis, the transfer of the Regulatory Approvals, the Transferred Clinical Trial Authorizations, and the Transferred Orphan Designations has been legally effected (including through any decision or action of any competent Regulatory Agency), BioMarin shall, with respect to each such Regulatory Approval, Transferred Clinical Trial or Transferred Orphan Designation transferred to BioMarin (or an Affiliate or sublicensee of BioMarin), assume all obligations under Law from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, date of such transfer in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain connection with such Regulatory Approvals, Transferred Clinical Trial Authorizations and Transferred Orphan Designations. (g) From and after the time at which, on an individual basis, the transfer of the Regulatory Approvals, the Transferred Clinical Trial Authorizations, and the Transferred Orphan Designations has been legally effected (including through any decision or action of any competent Regulatory Agency), BioMarin shall assume all responsibility for all communications with and submissions to the applicable Governmental Body with respect to the Product in each casesuch jurisdiction where such Regulatory Approvals, Transferred Clinical Trial Authorizations and Transferred Orphan Designations has been legally effected, and Merck Serono shall not communicate with any such Governmental Body with respect to the Product in the Territory, except as may be required by Law or as may be requested by BioMarin or by a Governmental Body, subject to the last sentence of Section 6.06(b). (h) From and after the Transfer Time, BioMarin shall assume responsibility for all pharmacovigilance activities relating to the Product including, without limitation, responsibility for notifying the Regulatory Agencies of any Adverse Events in accordance with the terms and conditions of this AgreementLaw. 6.6.3 Except (i) Notwithstanding anything in this Agreement to the extent otherwise provided contrary, in the event that any regulatory responsibility assigned to BioMarin under this Agreement (including this Section 6.06) cannot be performed by BioMarin due to Law, Merck Serono agrees to assume such regulatory responsibilities and perform such responsibilities as a Transition Service under Article V during the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesPeriod.

Regulatory Responsibilities. 6.6.1 From (a) Merck Serono shall be responsible for notifying the clinical investigative sites and investigators participating in the Existing Clinical Trials (collectively, the “Investigators”) regarding the termination of Merck Serono’s responsibility for the applicable Existing Clinical Trial and the assumption of sponsorship and control of such Existing Clinical Trial by BioMarin. Merck Serono shall be responsible for executing any required amendments or agreements with the Investigators in connection with the foregoing, and will be solely responsible for ensuring that all Existing Clinical Trials are transferred in compliance with all Laws and regulations. (b) Merck Serono shall notify BioMarin of the occurrence and content of any material communication between Merck Serono or any of its Affiliates, on the one hand, and any Government Body (including the EMA or any similar Entity), on the other hand, concerning the Products, the Regulatory Approvals, the Transferred Clinical Trial Authorizations or the Transferred Orphan Designations (including communications relating to the transfer thereof to BioMarin), whether written or oral, as soon as reasonably practicable, but in no event later than three Business Day after the Closingreceipt of such communication, subject and shall promptly provide BioMarin with copies of all written communications and materials related thereto. Merck Serono shall obtain BioMarin’s prior written consent (which shall not be unreasonably withheld, conditioned or delayed) prior to finalizing and making any regulatory filings or submissions to any Governmental Body or providing any response to communications from a Governmental Body relating to the terms of Products, the Transition Services Agreement Regulatory Approvals, the Transferred Clinical Trial Authorizations and except the Transferred Orphan Designations. (c) Except as required by a Party to comply with applicable Law Law, from and after the date that the transfer of a Regulatory Approval, Transferred Clinical Trial Authorization or Transferred Orphan Designation has been legally effected (including through any decision or action of any competent Regulatory Agency), BioMarin shall, with respect to exercise its rights and obligations hereunder each such Regulatory Approval, Transferred Clinical Trial or under any other Ancillary AgreementTransferred Orphan Designation transferred to BioMarin, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product BusinessApprovals, Transferred Clinical Trial Authorizations or Transferred Orphan Designations, and for conducting communications with Governmental Authorities Bodies of competent jurisdiction, for Seller the Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 (d) Subject to the terms provisions of the Transition Services Agreement Safety Data Exchange Agreement, Merck Serono shall, and shall cause its Affiliates to, notify BioMarin of all product complaints received by Merck Serono or its Affiliates relating to the Products. A product complaint received by Merck Serono or its Affiliates which also involves an Adverse Events report shall be reported by Merck Serono or its Affiliates to BioMarin as set forth in the Safety Data Exchange Agreement. Prior to the Transfer Time, Merck Serono shall have all responsibility for required reporting of Adverse Events for the Products in the Territory. On and after the Transfer Time, BioMarin shall have all responsibility for required reporting of Adverse Events for the Products, including in the Territory. BioMarin and Merck Serono shall, and Merck Serono shall cause its Affiliates to, cooperate with each other in connection with any investigation and response to any product complaint. (e) Subject to section 4.02, Merck Serono and BioMarin shall promptly after the Transfer Time, take all actions required to effect or evidence the change of ownership of any Regulatory Approvals, Transferred Clinical Trial Authorizations and Transferred Orphan Designations from Merck Serono to BioMarin (or an Affiliate or sublicensee of BioMarin). (f) From and after the time at which, on an individual basis, the transfer of the Regulatory Approvals, the Transferred Clinical Trial Authorizations, and the Transferred Orphan Designations has been legally effected (including through any decision or action of any competent Regulatory Agency), BioMarin shall, with respect to each such Regulatory Approval, Transferred Clinical Trial or Transferred Orphan Designation transferred to BioMarin (or an Affiliate or sublicensee of BioMarin), assume all obligations under Law from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, date of such transfer in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain connection with such Regulatory Approvals, Transferred Clinical Trial Authorizations and Transferred Orphan Designations. (g) From and after the time at which, on an individual basis, the transfer of the Regulatory Approvals, the Transferred Clinical Trial Authorizations, and the Transferred Orphan Designations has been legally effected (including through any decision or action of any competent Regulatory Agency), BioMarin shall assume all responsibility for all communications with and submissions to the applicable Governmental Body with respect to the Product in each casesuch jurisdiction where such Regulatory Approvals, Transferred Clinical Trial Authorizations and Transferred Orphan Designations has been legally effected, and Merck Serono shall not communicate with any such Governmental Body with respect to the Product in the Territory, except as may be required by Law or as may be requested by BioMarin or by a Governmental Body, subject to the last sentence of Section 6.06(b). (h) From and after the Transfer Time, BioMarin shall assume responsibility for all pharmacovigilance activities relating to the Product including, without limitation, responsibility for notifying the Regulatory Agencies of any Adverse Events in accordance with the terms and conditions of this AgreementLaw. 6.6.3 Except (i) Notwithstanding anything in this Agreement to the extent otherwise provided contrary, in the event that any regulatory responsibility assigned to BioMarin under this Agreement (including this Section 6.06) cannot be performed by BioMarin due to Law, Merck Serono agrees to assume such regulatory responsibilities and perform such responsibilities as a Transition Service under Article V during the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesPeriod.

Regulatory Responsibilities. 6.6.1 From (a) Licensee shall use Commercially Reasonable Efforts to obtain and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all maintain Regulatory Approvals necessary for Product in the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller ProductsLicensee Territory. Without limitation of limiting the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating Licensee shall use Commercially Reasonable Efforts to any Seller obtain and maintain Regulatory Approval for Product received by Sellerin at least one (1) Major Market Country, its Affiliateswithin eighteen (18) months after the Effective Date, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case Licensee shall commit two hundred thousand dollars ((i) and (ii)$200,000), within ten or its equivalent in kind, annually towards such efforts until it obtains Regulatory Approval for Product in the Licensee Territory. Licensee shall keep Licensor reasonably informed with respect thereto through the JSC (10) Business Days after Seller’s receipt, submission or production of a subcommittee established by the foregoing, as applicableJSC). To the extent applicablepermitted by Applicable Law, Seller as between the Parties, Licensee (or its designee) shall own all right, title, and interest in and to, and shall be the holder of, all Regulatory Approvals of Product in the Licensee Territory. (b) Licensor shall use Commercially Reasonable and Diligent Efforts to obtain and maintain Regulatory Approvals for SP-103 and all existing Products in each country or jurisdiction in the Licensor Territory. Licensor shall keep Licensee reasonably informed with respect thereto through the JSC (or a subcommittee established by the JSC). Licensor shall use reasonable efforts to cause Licensee to be a designated third-party beneficiary of each Licensor Regulatory Agreement, entitled to the rights and benefits of each Licensor Regulatory Agreement as Licensor is so entitled. Licensor shall provide Purchaser Licensee with a draft copy of each Licensor Regulatory Agreement promptly after entering into it. Licensor shall timely pay in full all amounts required to be paid by Licensor, and timely perform in full all obligations required to be performed by Licensor, under all Licensor Regulatory Agreements. Licensor promptly shall provide Licensee with copies of all notices and other deliveries received under any Licensor Regulatory Agreement. Without the prior express written consent of Licensee, Licensor shall not (and shall take no action or make no omission to) modify or waive any provision of any written response thereto Licensor Regulatory Agreement if doing so may reasonably in advance (in light impair the value of the prevailing circumstances) licenses or rights granted to Licensee herein, or to terminate or have terminated any Licensor Regulatory Agreement if doing so may reasonably impair the value of submitting such response the licenses or rights granted to the applicable Regulatory AuthoritiesLicensee herein.

Regulatory Responsibilities. 6.6.1 From (a) Virobay shall prepare a draft IND for VBY-891 in the U.S. in accordance with the Development Plan, shall submit such draft IND to XXX for review and comment, and shall include all reasonable comments of XXX thereto that are received by Virobay within [* * *] Business Days after LEO’s receipt thereof. Upon LEO’s approval, Virobay shall file the Closingdraft IND with the FDA. XXX shall be responsible for all reasonable costs and expenses incurred by Virobay to conduct such activities as provided in Section 4.3. Upon completion of all of Virobay’s activities under the Development Plan, subject Virobay shall assign and transfer the IND for VBY-891 in the U.S. and related Regulatory Materials to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary AgreementXXX, Purchaser at LEO’s expense. (b) Following such transfer, XXX shall have the sole right and responsibility for preparing, obtaining and maintaining own all Regulatory Approvals necessary Materials (including all INDs, NDAs, XXXx and Regulatory Approvals) for each Licensed Product in the Field in the Territory. Other than the IND prepared by Virobay, XXX shall be solely responsible for preparing and filing any and all other Regulatory Materials for each Licensed Product in the Field in the Territory, at its sole expense. Virobay shall assist and cooperate with XXX in connection with the preparation of such Regulatory Materials, as reasonably requested by XXX and at LEO’s expense. (c) Except as expressly contemplated by this Agreement or otherwise agreed to in writing by the Parties, XXX shall be responsible for all Regulatory Materials and filings with Regulatory Authorities for the Product Business, Compounds or the Licensed Products in the Territory and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser Virobay shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all not submit any Regulatory Materials or seek Regulatory Approvals for the Seller Compounds or the Licensed Products in the Territory. XXX shall timely notify Virobay of any meeting (whether in person or by conference call) requested or scheduled with a Regulatory Authority with respect to the Compounds or Licensed Products. Virobay may, including providing necessary documents on reasonable prior notice to XXX, have no more than [* * *] representatives participate in any such meeting. Except as provided in the preceding sentence, Virobay shall not communicate formally or other materials informally with respect to the Compounds or the Licensed Products with any Regulatory Authority, unless so required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvalscomply with Applicable Laws, in each casewhich case Virobay shall promptly notify XXX of such requirement under Applicable Laws and, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreementpracticable and permitted under applicable Laws, from and after the Closingshall submit any proposed communication to XXX for prior approval or, Seller if not practicable or permitted, shall provide Purchaser XXX with (i) copies of all written a copy or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, summary thereof as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto soon as reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authoritiespracticable thereafter.

Regulatory Responsibilities. 6.6.1 From and after (i) As between the ClosingParties, subject to Section 9.2(c)(iii), the terms Party designated in accordance with the provisions of this Agreement as the Transition Services Agreement and except as required by LRP with respect to a Party to comply with applicable Law particular set of Development, Manufacturing or to exercise its rights and obligations hereunder Commercialization activities for a particular Development Candidate, Product Candidate or under any other Ancillary Agreement, Purchaser Product in a particular country in the Territory shall have the sole right and responsibility (but subject to the other Party’s rights of participation as set forth herein) for preparing, obtaining obtaining, and maintaining all Drug Approval Applications, other Regulatory Approvals necessary for the Product Businessand other submissions, and for conducting communications with Governmental the Regulatory Authorities, with respect to the specific activities for which it is designated as LRP. (ii) All Regulatory Documentation (including all Regulatory Approvals and Product Labeling) relating to the applicable Development Candidate, Product Candidate or Product with respect to the applicable Development, Manufacturing, or Commercialization activities in the applicable countries shall be owned by the applicable LRP or its designee. The Party that is not the LRP with respect to the applicable Development Candidate, Product Candidate or Product for the applicable Development, Manufacturing, or Commercialization activities in the applicable countries shall assign to the LRP all of its right, title, and interest in and to the applicable Regulatory Documentation (including any existing Regulatory Approvals) with respect to the applicable Product or New Collaboration Compound in the applicable countries, including Regulatory Documentation with respect to activities for which such Party was the LRP in a previous stage of Development, subject to such Party’s right of access, reference and use of Regulatory Data and Regulatory Documentation pursuant to Section 6.3, Section 10.1 and Section 10.5. (iii) For all Joint Products, the LRP shall provide the other Party with an opportunity to review and comment on all Regulatory Documentation for Joint Products in the applicable countries in the Profit Share Territory, and all proposed actions with respect thereto, prior to submission thereof or the taking of the action. The LRP shall provide the other Party with access to interim drafts of the Regulatory Documentation for Joint Products in the applicable countries in the Profit Share Territory via the access methods (such as secure databases) established by the applicable JDC, and the other Party shall provide its comments on the then-current drafts of such Regulatory Documentation or of proposed actions within [***] days ([***] for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties. In the event that a Regulatory Authority establishes a response deadline for a regulatory filing or action shorter than such ([***])-day (or [***]-day) period, the Parties shall work cooperatively to ensure the other Party has a reasonable opportunity for review and comment within such deadlines. The LRP shall consider in good faith any such comments of the other Party. (iv) For all Joint Products, the LRP shall provide the other Party with (A) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the Development or Commercialization of Joint Products in the applicable countries in the Profit Share Territory received by such Party or its Affiliates from, or forwarded by such Party or its Affiliates to, the Regulatory Authorities in the applicable countries, and (B) copies of competent jurisdictionall meeting minutes and summaries of all meetings, for Seller Products. Without limitation conferences, and discussions held by such Party or its Affiliates with the Regulatory Authorities relating to such Joint Products in such applicable countries, including copies of all contact reports produced by such Party or its Affiliates, in each case ((A) and (B)) within [***] Business Days of its receipt, forwarding or production of the foregoing, promptly following as applicable. If such written or electronic correspondence received from a Regulatory Authority relates to the Closingwithdrawal, Purchaser suspension, or revocation of a Regulatory Approval for a Joint Product, the prohibition or suspension of the supply of a Joint Product, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety of a Joint Product, such Party shall obtain notify the other Party and provide the other Party with copies of such FDA approvals written or electronic correspondence as are necessary for Purchaser’s own Product labeling and shall comply with soon as practicable, but not later than [***] Business Day after receipt of such FDA approvals upon receipt thereofcorrespondence. 6.6.2 Subject (v) For all Joint Products, the LRP shall provide the other Party with prior written notice, to the terms extent the LRP has advance knowledge, of any meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the applicable countries relating to the applicable Development, Manufacture, or Commercialization of a Joint Product in the Profit Share Territory, within [***] Business Days after the Party or its Affiliate first receives notice of the Transition Services Agreement from scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to attend such meeting, conference, or discussion). The other Party shall have the right to attend as an observer (but not participate in) all such meetings, conferences, and after discussions. (vi) For all Joint Products, the Closing, Seller Party that is not the LRP shall support Purchaserthe LRP, as may be reasonably necessary and practicable, at Purchaser’s cost and expensenecessary, in preparing, obtaining and maintaining all Regulatory Approvals Approval for Joint Products in the Seller Productsapplicable countries in the Profit Share Territory, including providing necessary documents or other materials required by applicable Applicable Law for Purchaser to obtain or and maintain such Regulatory ApprovalsApproval, in each case, case in accordance with the terms and conditions of this AgreementAgreement and any applicable Development Plan. 6.6.3 Except (vii) For any Joint Product in any particular Commercialization Territory, in the event a Party becomes the new Lead Regulatory Party, the other Party shall promptly provide to such new Lead Regulatory Party copies of or access to all non-clinical data, Clinical Data and other Information, results and analyses with respect to such Joint Product to the extent otherwise provided not already in the Transition Services Agreementpossession of such new Lead Regulatory Party, from as may be reasonably necessary for obtaining and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller maintaining Regulatory Approval for such Joint Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Productin such Commercialization Territory, including copies of all contact reports produced providing necessary documents or other materials required by Seller Applicable Law to obtain and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable maintain Regulatory AuthoritiesApproval.

Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 (a) Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except , Terns will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to the extent otherwise provided obtain and maintain Regulatory Approval of Licensed Products in the Transition Services AgreementField in the Terns Territory, from including the preparation and after submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the ClosingTerns Territory. Terns shall be responsible for filing each CTA in the Terns Territory for each Licensed Product, Seller provided that, if required under applicable Laws, Terns (or its Affiliate) and Genfit will file such CTA(s), and will hold such CTA(s) as co-sponsors. Terns shall provide Purchaser with be responsible for filing each MAA in the Terns Territory for each Licensed Product in Terns’ name, if permitted by applicable Laws. Notwithstanding the above, if applicable Laws require Terns to file an MAA in Genfit’s name, then (i) copies Genfit shall initially be the holder of all written or electronic correspondence relating to any Seller the Regulatory Approval for each Licensed Product received by Sellerin the Terns Territory, its Affiliatesand Genfit hereby designates Terns as Genfit’s regulatory agent and exclusive general distributor for the Licensed Product in the Terns Territory, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies as soon as permitted by applicable Laws, Genfit shall promptly assist and cooperate with Terns and transfer and assign all Regulatory Approvals and Regulatory Materials (including any CTAs filed as set forth above) for each Licensed Product in the Terns Territory to Terns to allow Terns to be the holder of the Regulatory Approval for each Licensed Product in the Terns Territory. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Terns Territory. Terns shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products pursuant to such strategy. (b) Genfit shall provide all meeting minutes reasonable assistance and other similar summaries cooperation to Terns as Terns may reasonably request, at Terns’ sole cost and expense, during the Term of all meetingsthis Agreement, conferences and discussions held by Seller with Regulatory Authorities respect to the extent relating to any Seller Productsatisfaction of its obligations under Section 5.1(a), including copies (i) in connection with the preparation of all contact reports produced Regulatory Materials, (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings by Seller teleconference and its Affiliates, licensees, sublicensees (B) providing documentation within Genfit’s possession and distributorscontrol, in each case ((i) as requested by Regulatory Authorities at Terns’ cost, and (ii))iii) providing Terns with additional Regulatory Materials in the Genfit Territory as requested by Regulatory Authorities in the Terns Territory within a reasonable timeframe commensurate with the volume of Terns’ reasonable request. In the event that Genfit believes that such requests are not reasonable or are otherwise burdensome to Genfit, then such matter shall be promptly submitted to the JSC for review and discussion. Without limiting the foregoing, Genfit shall provide Terns with [***] of the CTD for any formulation of Licensed Product for which Genfit has prepared a CTD for Regulatory Filings in the Field in the Genfit Territory, in a manner sufficient for filing in the U.S. within ten [***] after completion of all such [***] of the CTD. Terns shall be responsible for publishing and submitting the CTD (10including [***]) Business Days after Seller’s receipt, submission to the Regulatory Authority in the Terns Territory. Any such transfer of CMC Information as set forth in this Section 5.1 is conditioned on Terns establishing appropriate firewalls or production equivalent means designed to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose. In furtherance of the foregoing, as applicableTerns shall ensure that any CMC Information provided by or on behalf of Genfit pursuant to this Section 5.1 shall only be disclosed to those identified personnel of Terns (or a designated agreed Third Party) who (x) have a need to know the same to comply with the above obligations, and (y) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent means. To Notwithstanding anything to the contrary herein, Genfit’s obligations under this Section 5.1(b), including to provide Terns with [***] of the CTD and such other information or assistance specified in this Section 5.1(b), shall apply solely to the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesGenfit is Manufacturing and supplying Terns with Licensed Products.

Regulatory Responsibilities. 6.6.1 From (a) As between the Parties, Licensee will be solely responsible for all regulatory submissions and after exchanges and will direct and control all regulatory activities with respect to Compounds and Products in the ClosingTerritory, subject including responses and correspondence, safety reporting, negotiation, analysis, and strategy. Licensor will provide timely and appropriate support to Licensee with respect to such regulatory activities [***] and will, at Licensee’s request, promptly transfer all Regulatory Materials and Information in Licensor’s possession or under Licensor’s Control related to any Compound or Product to Licensee. (b) Licensee will be the terms primary interface with and will otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning regulatory or other activities related to Compounds or Products in the Field in the Territory, and Licensee will prepare and file any and all Regulatory Materials for each Compound or Product in the Field in the Territory [***]. Licensor will assist and cooperate, in a timely manner, [***], with Licensee in connection with the preparation and filing of such Regulatory Materials, as reasonably requested by Licensee. Such cooperation will include promptly responding within procedural or other timelines set by Regulatory Authorities or any applicable Law to any reasonable request from Licensee for Licensor Know-How or other Information needed for the Transition Services Agreement and Regulatory Materials. (c) Unless the Parties otherwise agree in writing: (i) except as required expressly contemplated by a Party this Section 5.1, Licensor will not communicate with respect to comply any Compound or Product in the Field with applicable Law any Regulatory Authority having jurisdiction in the Territory, unless so ordered by such Regulatory Authority, or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory ApprovalsLaw, in each case, which case Licensor will provide prompt (but in accordance with the terms and conditions any event within [***] Business Days) notice to Licensee of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors fromsuch order, or submitted upon realizing such requirement is imposed by SellerLaw, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authoritiesand all details thereof; and (ii) copies of all meeting minutes and other similar summaries of all meetingsexcept as expressly contemplated by this Section 5.1, conferences and discussions held Licensor will not submit any Regulatory Materials or seek Regulatory Approvals by Seller with Regulatory Authorities to or for itself for any Compound or Product in the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, Field in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesTerritory.

Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 (a) Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except , SAMR will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to the extent otherwise provided obtain and maintain Regulatory Approval of Licensed Products in the Transition Services AgreementApplicable Territory, from and after including the Closing, Seller shall provide Purchaser with (i) copies preparation of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; Materials and (ii) copies of all meeting minutes communications and other similar summaries of all meetings, conferences and discussions held by Seller interactions with Regulatory Authorities in the Applicable Territory with respect to Licensed Products. SAMR shall be responsible for filing each MAA in the Applicable Territory for each Licensed Product and will be the holder of (or its distributing sub-licensee shall be the holder of, on behalf of SAMR) the Regulatory Approval for each Licensed Product in the Applicable Territory. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Applicable Territory. SAMR shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products pursuant to such strategy. (b) With respect to AR-201 Product and Limited License Products, the following terms shall apply: Aridis shall provide such assistance and cooperation to SAMR as SAMR may reasonably request (subject to SAMR’s reimbursement of Aridis’s external costs and expenses related thereto), with respect to the extent relating to any Seller Productsatisfaction of its obligations under Section 5.1(a), including copies in connection with the preparation of all contact reports produced Regulatory Materials. Aridis shall provide such sections of any Common Technical Document or other Regulatory Materials as are in its possession as are reasonably necessary for SAMR’s satisfaction of its obligations hereunder and as agreed by Seller the JSC. Any transfer of CMC Information, Regulatory Materials or other Aridis Data or Aridis IP as set forth in this Section is conditioned on SAMR establishing appropriate firewalls or equivalent means to ensure that such Information is protected from unauthorized disclosure and its Affiliatesis used only for legal and regulatory compliance purposes and not for any other purpose. SAMR shall ensure that any information provided by or on behalf of Aridis pursuant to this Section 5.1 shall only be disclosed to those identified personnel of SAMR (or a designated agreed Third Party) who (a) have a need to know the same to comply with the above obligations, licensees, sublicensees and distributors, in each case ((i) and (ii))b) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, within ten (10) Business Days after Seller’s receipt, submission by using the firewall or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authoritiesequivalent means.

Regulatory Responsibilities. 6.6.1 From and after the Closing, subject (a) Each Party shall provide to the terms other copies of all label-enabling Regulatory Submissions, including the Transition Services Agreement initial BLA, for submission to a Regulatory Authority [ * ] with respect to the RC48 Licensed Product and except as required by a Opt-In Products reasonably in advance of such submission for the other Party’s review and comment (including English translations thereof), and shall consider in good faith any reasonable comments received from the other Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any respect thereto. Each Party shall keep the other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining Party reasonably informed of all Regulatory Approvals necessary for and, [ * ], other material, regulatory developments related to the Royalty Products (in the case of Seagen) and the RC48 Licensed Product Businessand Opt-In Products (in the case of RemeGen) in its respective Territory [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. and shall promptly notify such other Party in writing of any decision by any Regulatory Authority in the notifying Party’s Territory regarding any Royalty Product in the Field. All regulatory activities conducted, and for conducting communications Regulatory Submissions prepared, by or on behalf of each Party with Governmental Authorities respect to the Royalty Products (in the case of competent jurisdiction, for Seller Products. Without limitation Seagen) and the RC48 Licensed Product and Opt-In Products (in the case of the foregoing, promptly following the Closing, Purchaser RemeGen) shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling be conducted and shall comply prepared in strict compliance with such FDA approvals upon receipt thereofApplicable Laws. 6.6.2 Subject (b) Except as set forth in the Global Development Plan or with respect to Seagen’s conduct of any Global Trial for a Royalty Product in the terms of the Transition Services Agreement from and after the ClosingRemeGen Territory as permitted hereunder, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expenseunless required by such Regulatory Authority, in preparingwhich case such Party shall notify the other Party of such order within [ * ] of such communication, obtaining and maintaining all neither Party shall file any Regulatory Approvals Submissions nor communicate with any Regulatory Authority for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided any Royalty Product in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with other Party’s Territory. With respect to (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from[ * ], or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors[ * ], in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To to the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to permitted by Applicable Law and by the applicable Regulatory Authorities, Seagen and RemeGen, respectively, shall have the right (but not the obligation) to attend (including attending in person as applicable) as an observer in all such meetings, provided that such attendance shall be (a) limited to up to [ * ] of the attending Party, and (b) at [ * ] cost unless such attendance is at the other Party’s request, in which case [ * ]. Each Party shall provide the other Party with written notice [ * ]. The notifying Party shall lead any such meeting or discussion with Regulatory Authorities. Each Party shall provide the other Party with a written summary of each such meeting or discussion, and meeting minutes from such meetings with Regulatory Authorities promptly (but in any event within [ * ], and an English translation (if applicable) within [ * ] (or within [ * ] if pertaining to a Collaborative Global Trial) following such meeting or discussion.

Regulatory Responsibilities. 6.6.1 From Subject to Section 3.3(d), and after prior to the Closingtransfer contemplated in Section 3.6(c) below, Protalix shall, subject to Chiesi’s direction and approval (by and through the terms Steering Committee or otherwise), be responsible for implementing all pre-Regulatory Approval regulatory plans and strategies for, and making any regulatory filings in respect of, the Licensed Product in the Field in the Territory (excluding, for the avoidance of doubt, any application to a Regulatory Authority seeking Regulatory Approval, which shall in each case, be in the Transition Services Agreement name of, and except as required by a Party to comply with applicable Law submitted by, Chiesi). Without limiting the foregoing, following the transfer contemplated in Section 3.6(c): (i) Chiesi (or to exercise one or more of its rights designated Affiliates) will own and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility be responsible for preparing, obtaining seeking, and submitting such regulatory filings as are necessary to obtain Regulatory Approval and then maintaining all Regulatory Approvals necessary and any post-approval regulatory filings, for the Licensed Product Businessin the Field in such Country in the Territory, including preparing all reports necessary as part of such Regulatory Approvals or post-approval regulatory filings. Protalix shall have the right and be responsible to prepare and promptly submit to Chiesi any non-clinical, clinical and Manufacturing portions (including CMC) of such regulatory filings and any related reports (subject to Chiesi’s approval rights with respect to such regulatory filing as a whole), at Chiesi’s sole cost and expense (unless such costs are Development Costs or other costs expressly addressed hereunder or by a separate agreement between the Parties, such as in relation to [***] or costs for Event Milestone 1a Studies). Protalix shall consider in good faith any proposed revision reasonably made by Chiesi thereto and Protalix shall otherwise provide such assistance as Chiesi reasonably requires, at Chiesi’s sole cost and expense (unless such costs are Development Costs or other costs expressly addressed hereunder or by a separate agreement between the Parties, such as in relation to [***] or costs for Event Milestone 1a Studies), to obtain Regulatory Approvals for the Licensed Product in the Field in the Territory. (ii) Following the transfer contemplated in Section 3.6(c), but in any event, no later than the grant of Regulatory Approval, on a Country-by-Country basis, Chiesi shall (A) subject to Section 5.3(d), assume sole responsibility for seeking authorization in respect of, conducting, and for conducting communications otherwise interacting with Governmental Regulatory Authorities of competent jurisdictionin respect of, for Seller Products. Without limitation of any Post-Approval Studies, and (B) have the foregoingright to apply for, promptly following the Closingand secure, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as exclusivity rights that may be available under the Laws of such Countries in the Territory, including any Regulatory Exclusivity. Protalix shall reasonably necessary cooperate with Chiesi, and practicabletake such reasonable actions to assist Chiesi, at PurchaserChiesi’s sole cost and expense, in preparingobtaining such exclusivity rights in each Country, obtaining as Chiesi may reasonably request from time to time. For the avoidance of doubt (A) at all relevant times during the Term, Chiesi shall have the final decision-making authority in respect of all regulatory plans and maintaining all Regulatory Approvals strategies for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided Licensed Product in the Transition Services Agreement, from Field in the Territory; provided that Chiesi shall reasonably consider any comments on such plans and after strategies that Protalix may communicate (through the Closing, Seller shall provide Purchaser with (i) copies of all written Steering Committee or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authoritiesotherwise); and (iiB) copies following a Regulatory Approval in a Country in the Territory, Chiesi shall be solely responsible for any such activities as are initiated after the date of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with such Regulatory Authorities Approval that would otherwise constitute Development activities had they been initiated prior to the extent relating to any Seller Product, including copies grant of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesApproval.

Regulatory Responsibilities. 6.6.1 From (a) Except for the Joint IND, which shall be jointly owned, Ascletis shall own all Regulatory Approvals for Product in the Field in the Territory. Ascletis shall have sole responsibility for: (i) obtaining and after maintaining Regulatory Approvals for Products in the ClosingField in the Territory, subject and shall use Diligent Efforts to obtain Regulatory Approval of the Product and, upon obtaining Regulatory Approvals for the Product in the Field in the Territory, maintain such Regulatory Approvals; and (ii) other communications with applicable Regulatory Authorities in the Territory relating to the terms Development and Commercialization of Compound and Product, including (i) all correspondence submitted to Regulatory Authorities in the Transition Services Agreement Territory related to the design, conduct or results of non-clinical studies and except as required clinical trials; (ii) all pricing and reimbursement approval proceedings in the Territory; and (iii) all proposed product labeling for the Product in the Field in the Territory. (b) Ascletis shall provide 3-V with synopsis of all regulatory submissions and reasonable time prior to submission for review and comment if possible, and shall consider in good faith any comments received from 3-V. In addition, Ascletis shall notify 3-V of any regulatory material submitted to or received from any Regulatory Authority in the Territory and shall provide 3-V with copies thereof ([***]) within [***] days after submission or receipt. (c) Ascletis shall provide 3-V with reasonable advance notice of any meeting or discussion with any Regulatory Authority in the Territory related to Phase 2 Global Multi-Center Trial or any Phase 2 Clinical Trials or Phase 3 Clinical Trials conducted by a Party to comply with applicable Law Axxxxxxx in the Territory. Ascletis shall lead such meeting or to exercise discussion, provided however that 3-V or its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser designee shall have the sole right, but not the obligation, to attend and participate in such meeting or discussion. If 3-V elects not to attend such meeting or discussion, Axxxxxxx shall promptly provide 3-V with a written [***] summary of such meeting or discussion. Regarding subsequent clinical trials (other Phase 2 Clinical Trials or Phase 3 Clinical Trials conducted by Ascletis) in the Territory, Ascletis shall provide 3-V with regular updates and summaries of such meetings. (d) Each Party hereby grants to the other Party the right and responsibility of reference to all regulatory submissions pertaining to the Product submitted by or on behalf of such Party. Ascletis may use such right of reference to 3-V’s regulatory submissions solely for preparingthe purpose of seeking, obtaining and maintaining all Regulatory Approvals necessary Approval of the Product in Field in the Territory. 3-V may use the right of reference to Ascletis’ regulatory submissions solely for the Product Business, and for conducting communications with Governmental Authorities purpose of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparingseeking, obtaining and maintaining all Regulatory Approvals Approval of the Product outside the Territory. For global clinical trials conducted by 3-V for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided Product in the Transition Services AgreementTerritory, from 3-V shall be entitled to conduct clinical audits (including on-site audits) as would be customary for global clinical trials and after the Closing, Seller shall provide Purchaser consistent with (i) copies monitoring by sponsor of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authoritiestrials.

Regulatory Responsibilities. 6.6.1 From (a) Subject to the completion by AMAG of the Pivotal Clinical Trial as set forth in the Development Plan, Norgine shall use Commercially Reasonable Efforts to seek and after maintain Regulatory Approval (and required pricing and reimbursement approvals) for the ClosingProduct in the Norgine Territory, and to achieve each Regulatory Milestone Event. Without limiting the foregoing, subject to the terms and conditions of this Agreement, Norgine shall be responsible for, [***], (i) the filing and obtaining of all Regulatory Submissions, (ii) responding to inquiries and correspondence from the Regulatory Authorities and (iii) the submission of all required reports throughout clinical Development (after completion of the Transition Services Agreement Pivotal Clinical Trial) and except as required by a Party to comply with applicable Law Commercialization, in each case ((i) through (iii)) in or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product BusinessNorgine Territory, in compliance with all Applicable Laws and for conducting communications Regulations. Norgine or its designee shall hold and own all such Regulatory Submissions. At the reasonable request [***], AMAG will reasonably assist Norgine in connection with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for PurchaserNorgine’s own Product labeling and shall comply activities under this Section 3.3(a) with such FDA approvals upon receipt thereof. 6.6.2 Subject respect to the terms of Product in the Transition Services Agreement from and after Field in the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller ProductsNorgine Territory, including providing necessary documents or other materials required by applicable Law Applicable Laws and Regulations. (b) Norgine shall notify AMAG of any material written or electronic communication received by Norgine from a Regulatory Authority regarding the Product within [***] of receipt of such communication and upon AMAG’s request, provide a copy of such communication within [***] of such request unless otherwise specified by AMAG. AMAG shall be responsible for Purchaser providing to obtain Norgine any revisions to the investigator’s brochure and CMC information required for Regulatory Submissions. If permitted by the Regulatory Authorities, AMAG (or maintain such Regulatory Approvals, its designee) shall have a right to participate (and Norgine may otherwise request AMAG to participate) in each case, in accordance meetings with the terms Regulatory Authorities in the Major European Countries and conditions of this Agreementany rapporteur country regarding the Product. 6.6.3 Except to (c) As between the extent otherwise provided in the Transition Services AgreementParties, from and after the Closing, Seller AMAG shall provide Purchaser with be responsible for (i) copies of the filing and obtaining all written or electronic correspondence relating to any Seller Product received by SellerRegulatory Submissions, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies responding to inquiries and correspondence from the Regulatory Authorities responsible for regulatory matters, and (iii) the submission of all meeting minutes required reports throughout clinical Development and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributorsCommercialization, in each case ((i) through (iii)) ACTIVE/105730326.3 in the AMAG Territory, in compliance with all Applicable Laws and Regulations. AMAG shall notify Norgine of any material written or electronic communication received by AMAG from a Regulatory Authority regarding the Product within [***] of receipt of such communication and upon Norgine’s request, provide a copy of such communication within [***] of such request unless otherwise specified by Norgine. If permitted by the Regulatory Authorities, Norgine (ii)), within ten or its designee) shall have a right to attend (10and AMAG may otherwise request Norgine to participate in) Business Days after Seller’s receipt, submission or production of meetings with the foregoing, as applicable. To FDA regarding the extent applicable, Seller Product. (d) Each Party shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response information to the applicable other Party as necessary and reasonably consult with the other Party regarding any filings, and regarding significant or material notices, actions or requests from or by Regulatory AuthoritiesAuthorities in such Party’s territory. Each Party shall, at the other Party’s request, review and comment on filings, submissions, and responses to Regulatory Authorities related to the Product.

Regulatory Responsibilities. 6.6.1 5.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser (a) Buyer shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for the Product and any Other Product in the Buyer Territory, and (b) Seller Products(on its own behalf or through Seller’s licensees, sublicensees or distributors, as applicable) shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals, and for conducting communications with Governmental Authorities of competent jurisdiction, for the Product in the Seller Territory. Without limitation of the foregoing, promptly following the Closing, Purchaser Buyer shall obtain such FDA approvals as are necessary for PurchaserBuyer’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 5.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Closing (a) Seller shall support PurchaserBuyer, as may be reasonably necessary and practicable, at Purchaser’s cost and expense[***], in preparing, obtaining and maintaining all Regulatory Approvals for the Seller ProductsProduct in the Buyer Territory, including providing necessary documents or other materials required by applicable Law for Purchaser Buyer to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement; and (b) Buyer shall support Seller, as may be reasonably necessary and practicable, [***], in preparing, obtaining and maintaining all Regulatory Approvals for the Product in the Seller Territory, including providing necessary documents or other materials required by applicable Law for Seller to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except 5.6.3 Subject to the immediately following sentence and except to the extent otherwise provided in the Supply Agreement or the Transition Services Agreement, from and after the Closing, Seller (a) Buyer shall provide Purchaser Seller with (i) copies of all written or electronic correspondence relating to the Product or any Other Product in the Buyer Territory, received by Buyer, its Affiliates, licensees, sublicensees or distributors from, or submitted by Buyer, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Buyer with Regulatory Authorities to the extent relating solely to the Product or any Other Product, including copies of all contact reports produced by Buyer and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within [***] Business Days after Buyer’s receipt, submission or production of the foregoing, as applicable; and (b) Seller shall provide Buyer with (i) copies of all written or electronic correspondence relating to the Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating solely to any Seller Productthe Product in the Buyer Territory, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) [***] Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To If such written or electronic correspondence received from a Regulatory Authority relates to the withdrawal, suspension, revocation or variation of a Regulatory Approval for the Product or any Other Product, the prohibition or suspension of the supply of the Product or any Other Product, or the initiation of any investigation, review or inquiry by such Regulatory Authority concerning the safety of the Product or any Other Product, except to the extent applicableotherwise provided in the Supply Agreement, Seller then the Party that received such written or electronic correspondence shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable, but not later than [***] Business Days after receipt of such correspondence. The Party that received such written or electronic correspondence shall provide Purchaser the other Party a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities. Buyer shall notify Seller as soon as practicable if Buyer reasonably believes that the last patient last visit dates for the Phase IV Commitments will be delayed beyond the estimated dates included in the Phase IV Commitments as of the Closing Date (or any subsequent estimated dates).

Regulatory Responsibilities. 6.6.1 From 3.4.1 Prior to receipt of Regulatory Approval in the U.S. for the Initial Indication for Contrave: (a) Orexigen shall prepare, file, maintain, and own all Regulatory Filings, including the IND and the NDA for Contrave in the U.S., and related submissions with respect to Contrave in the U.S.; and (b) Orexigen shall promptly notify Takeda of all material Regulatory Filings with respect to Contrave that it proposes to submit to Regulatory Authorities, or that it receives from Regulatory Authorities, in the Territory (including all substantive correspondence with such Regulatory Authorities, responses from such Regulatory Authorities, requests for information from such Regulatory Authorities, briefing documents and other materials relating to interactions with such Regulatory Authorities, and summaries of outputs resulting from substantive correspondence/conversations or meetings with such Regulatory Authorities), and shall promptly provide Takeda with a copy (which may be wholly or partly in electronic form) of such Regulatory Filings for review by Takeda. Takeda shall provide any comments promptly, but in no event later than [***] ([***]) Business Days after receiving such Regulatory Filings, Orexigen shall reasonably consider and give due consideration to any such comments provided by Takeda, and, as necessary, it shall discuss such comments with Takeda, and each Party shall use good faith efforts to mutually agree on the Closingcontent of any communications that relate to or contain commitments made or to be made by Orexigen to Regulatory Authorities for the purpose of obtaining Regulatory Approvals; provided, subject however, (i) Orexigen shall retain the right to make any final decisions with respect to the terms content of any such communications, which shall be compliant with the Transition Services Development Plan, this Agreement and except as required by applicable Law, and (ii) in the event any interaction with a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary AgreementRegulatory Authority is time-sensitive, Purchaser Orexigen shall have the sole right to communicate with such Regulatory Authority within the time frame requested by such Regulatory Authority. Orexigen shall provide Takeda with reasonable advance notice of any scheduled meeting with any Regulatory Authority relating to the Product or any Regulatory Approval in the Territory, and Takeda shall have the right to have up to [***] ([***]) individuals attend and participate in any such meeting; provided, however, Orexigen will retain the lead role and responsibility in any such meetings. 3.4.2 Within [***] ([***]) days after receipt of written notice of Regulatory Approval in the U.S. for the Initial Indication for Contrave, but in any event prior to First Commercial Sale of Contrave, Orexigen and Takeda shall take all steps necessary to transfer all Regulatory Filings relating to Contrave, including the IND and the NDA for Contrave in the U.S., into the name of Takeda and provide Takeda with a copy of all such Regulatory Filings. Takeda shall thereafter be responsible for (a): preparing, obtaining filing, maintaining and maintaining owning *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. all Regulatory Approvals necessary Filings and related submissions, including the IND and the NDA for Contrave in the Product BusinessU.S., with respect to Products in all Indications in the Territory, and (b) leading discussions and meetings with all Regulatory Authorities regarding Products in all Indications in the Territory; provided, however, [***] ([***]) representatives of Orexigen shall be entitled to participate in any such discussions and meetings with Regulatory Authorities, and, if an appropriate Orexigen representative(s) is requested by Takeda to attend a discussion or meeting with a Regulatory Authority regarding the Products in the Indications in the Territory, Orexigen will use Commercially Reasonable Efforts to arrange for conducting communications such individual(s) to participate in such discussions or meetings. 3.4.3 Upon request, Takeda will provide the JSC with Governmental copies of all Regulatory Filings and related material correspondence submitted to Regulatory Authorities or received from Regulatory Authorities with respect to Products in all Indications in the Territory. Takeda will promptly furnish, but in no event later than [***] ([***]) Business Days after receipt or generation, Orexigen with copies of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain all such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply Regulatory Filings (including all substantive correspondence with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement Regulatory Authorities, responses from such Regulatory Authorities, requests for information from such Regulatory Authorities, briefing documents and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser relating to obtain or maintain interactions with such Regulatory ApprovalsAuthorities, in each caseand summaries of outputs resulting from substantive correspondence/conversations or meetings with such Regulatory Authorities). In addition, in accordance with the terms and conditions of this Agreement. 6.6.3 Except prior to making a Regulatory Filing relating to Contrave or responding to any such Regulatory Authority correspondence or interactions, except to the extent otherwise provided in the Transition Services Agreementimpracticable with respect to expedited safety reports, from timelines imposed by Regulatory Authorities, Takeda SOPs and after the Closingother similar time-sensitive issues, Seller Takeda shall provide Purchaser with (i) copies of all written or electronic correspondence relating to the JDC and JSC a complete draft copy for its review and comment. Takeda shall give due consideration to any Seller Product received by Sellercomments of the JDC and JSC with respect thereto. 3.4.4 Notwithstanding any transfer of Regulatory Filings or ownership thereof to Takeda, Orexigen shall have, on behalf of itself, its Affiliates, licenseesand licensees and sublicensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, the right to access and reference data and information contained in any Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities Filings to the extent relating useful or necessary in connection with Product regulatory filings outside the Territory. Orexigen hereby grants to Takeda, its Affiliates and Sublicensees, the right to access and reference data and information contained in any Orexigen’s Product regulatory filings outside the Territory to the extent useful or necessary in connection with Regulatory Filings inside the Territory. 3.4.5 If a Regulatory Authority desires to conduct an inspection or audit of, or sends a communication to, Takeda or Orexigen or any Third Party engaged by either Party to perform activities under the Development Plan or Commercialization Plan with regard to any Seller ProductProduct or this Agreement, Takeda and Orexigen each agrees to cooperate with the Regulatory Authority and the other Party during such inspection or audit, including copies by allowing, to the extent practicable, a representative of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case the other Party to be present during the applicable portions of such inspection or audit. Following receipt of the inspection or audit observations of the Regulatory Authority ((i) and (ii)a copy of which the responsible Party will immediately provide to the other Party), the responsible Party will prepare the response to any observation that concerned this Agreement. The other Party agrees to fully cooperate when it prepares such a response, including by providing to the responsible Party, within ten [***] (10[***]) Business Days after Sellerits *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. request, such information and documentation in the Party’s receiptpossession as may be necessary for the responsible Party to prepare such response. Before submitting the response to the Regulatory Authority, submission or production the responsible Party agrees to give the other Party a reasonable opportunity to comment on it. 3.4.6 Each Party (and its Third Party subcontractors) shall notify the other Party within [***] ([***]) Business Day of receipt of notification from a Regulatory Authority of the foregoingintention of such Regulatory Authority to audit or inspect a Party’s facilities with respect to any Product, as applicableincluding facilities being used for Manufacture of any Product. To Each Party (and its Third Party subcontractors) shall also provide the extent applicable, Seller shall provide Purchaser a draft other Party with copies of any written communications received from Regulatory Authorities with respect to such facilities within [***] ([***]) Business Days of receipt. Such Party shall provide the other Party with an opportunity to review and provide input on any proposed response thereto reasonably in advance by such Party (in light of the prevailing circumstancesor Third Party subcontractor) of submitting to such response to the applicable Regulatory Authoritiescommunications.

Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except , Licensee will be responsible, at its sole cost and expense, for all regulatory activities related to Development activities, as described in Section 4.1, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the extent otherwise provided same. Each Party shall use Commercially Reasonable Efforts to carry out its regulatory obligations for the Specialty Product in accordance with the strategy for obtaining Regulatory Approval of the Specialty Product in the Transition Services AgreementTerritory as set forth in the Development Plan or otherwise approved by the JSC pursuant to Section 3.3‎3.3. Licensee, from and after directly or through its Affiliates, shall use Commercially Reasonable Efforts to obtain Regulatory Approval in the ClosingTerritory. Notwithstanding the foregoing, Seller Licensee shall provide Purchaser be the Party responsible for achieving the regulatory milestones set forth on Exhibit G (the “Regulatory Milestones”). If Licensee fails to achieve any Regulatory Milestone with the time periods allotted for such Regulatory Milestone in Exhibit G, other than for reasons, being judged by the commonly accepted standards or practices in pharmaceutical industry of Territory, that are commercially impracticable or outside Licensee’s control, then Teva shall have the option in its sole discretion upon written notice to Licensee to: (i) copies extend the time period allotted for the achievement of all written the applicable Regulatory Milestone; or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies convert the exclusive rights granted to Licensee in Section 2.1(a) with respect to the given Specialty Product into nonexclusive rights, provided however, that Teva has called for the consultation(s) on such failure to achieve any Regulatory Milestone but both Parties are still unable to reach a solution within three (3) months as from the date of all meeting minutes the first consultation. All Regulatory Approvals and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities Materials relating to the extent relating to Licensed Products in the Territory shall be submitted in the name of, and shall be owned by, Teva or its Affiliate1. Bidding. Licensee shall be responsible for bidding activities for all Licensed Products in the Territory. Licensee shall keep Teva informed (through the Alliance Managers, the JDC or other means of communication) of any Seller Productmaterial issues concerning bidding process for all Licensed Products in the Territory, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft updates of any written response thereto discussion and correspondence with any Regulatory Authority with respect thereto. Licensee shall reasonably consider Teva’s comments with respect to Licensee’s or its Affiliate’s bidding activities for all Licensed Products in advance (the Territory and shall promptly notify Teva of bidding result for all Licensed Products in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesTerritory.

Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product BusinessBusiness in the Territory, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of Products in the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereofTerritory. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, the Seller Parties shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expenseexpense (unless otherwise provided in this Agreement), in preparing, obtaining and maintaining all Regulatory Approvals for the Seller ProductsProducts in the Territory, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, the Seller Parties shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product in the Territory received by Sellerthe Seller Parties, its their Affiliates, licensees, sublicensees or distributors from, or submitted by Sellerthe Seller Parties, its their Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by the Seller Parties with Regulatory Authorities to the extent relating to any Seller ProductProduct in the Territory, including copies of all contact reports produced by the Seller Parties and its their Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s the Seller Parties’ receipt, submission or production of the foregoing, as applicable. To the extent applicable, the Seller Parties shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.

Regulatory Responsibilities. 6.6.1 5.7.1 From and after the Closing, subject to the terms of Section 5.9, the Transition Services Agreement Ancillary Agreements and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser in accordance with the terms and subject to the conditions of the Dainippon License Agreement, Buyer shall have the sole right and responsibility for preparing(a) taking all actions, obtaining paying all fees and maintaining conducting all Regulatory Approvals necessary for the Product Business, and for conducting communications with applicable Governmental Authorities with respect to the U.S. Regulatory Approval, including preparing and filing all reports (including adverse drug experience reports) with applicable Governmental Authorities, (b) taking all actions and conducting all communications with Third Parties in respect of competent jurisdictionProduct sold pursuant to the U.S. Regulatory Approval in the Buyer Territory, for including responding to all complaints in respect thereof and (c) investigating all complaints and adverse drug experiences in respect of Product sold pursuant to the U.S. Regulatory Approval. Buyer shall consult Seller Products. Without limitation reasonably in advance of making any communications or filing any reports with any Governmental Authority with respect to adverse drug experiences relating to Product Manufactured prior to the foregoing, promptly following the Closing, Purchaser shall obtain Closing and consider in good faith any proposals by Seller with respect to such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereofcommunications. 6.6.2 5.7.2 Subject to the terms of the Transition Services Agreement Agreement, from and after the Closing, Closing (a) Seller shall support PurchaserBuyer, as may be reasonably necessary and practicable, at PurchaserBuyer’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller ProductsProduct in the Buyer Territory, including providing necessary documents or other materials required by applicable Law for Purchaser Buyer to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement; and (b) Buyer shall support Seller and its Affiliates, as may be reasonably necessary and practicable, at Seller’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Product and any Other Product in the Seller Territory, including providing necessary documents or other materials required by applicable Law for Seller to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except 5.7.3 Subject to the immediately following sentence and except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller (a) Buyer shall provide Purchaser Seller with (i) copies of all written or electronic correspondence relating to any the Product in the Buyer Territory, received by Buyer, its Affiliates, licensees, sublicensees or distributors from, or submitted by Buyer, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Buyer with Regulatory Authorities to the extent relating solely to the Product, including copies of all contact reports produced by Buyer and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within five Business Days after Buyer’s receipt, submission or production of the foregoing, as applicable; and (b) Seller shall provide Buyer with (i) copies of all written or electronic correspondence relating to the Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating solely to any the Product in the Seller ProductTerritory, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) five Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, . 5.7.4 Seller shall provide Purchaser a draft of be solely responsible for all costs associated with, or required to address, any written response thereto reasonably clinical findings or concerns regarding clinical data, in advance (either case, regarding the Product, that were conveyed by FDA to Seller in light of the prevailing circumstances) of submitting such response writing prior to the applicable Regulatory AuthoritiesClosing other than any such costs related to or arising out of data generated at or after the Closing.

Regulatory Responsibilities. 6.6.1 From and after (i) As between the ClosingParties, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser Licensee shall have the sole right and responsibility for preparing, obtaining obtaining, and maintaining all Regulatory Approvals necessary for Drug Approval Applications (including the Product Businesssetting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and for conducting communications with Governmental Authorities of competent jurisdictionthe Regulatory Authorities, for Seller Products. Without limitation Licensed Products in the Licensee Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities with respect to (A) Unilateral Activities of Licensor in the Licensee Territory ( provided that Licensor shall reimburse Licensee for its reasonable, fully-burdened costs for conducting such regulatory activities in support of Unilateral Activities of Licensor) and (B) Joint Development Activities). (ii) As between the Parties, Licensor shall have the sole right and responsibility for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the foregoingoverall regulatory strategy therefor), promptly following other regulatory approvals and other submissions, and for conducting communications with the ClosingRegulatory Authorities, Purchaser for Licensed Products in the Licensor Territory (including the Out-Licensed Territory (which shall obtain include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities with respect to (A) Unilateral Activities of Licensee in the Licensor Territory ( provided that Licensee shall reimburse Licensor for its reasonable, fully-burdened costs for conducting such FDA approvals as are necessary for Purchaser’s own regulatory activities in support of Unilateral Activities of Licensee) and (B) Joint Development Activities). (iii) All Regulatory Documentation (including Regulatory Approvals and Product labeling Labelling) relating to the Licensed Products with respect to the Licensee Territory shall be owned by, and shall comply be the sole property of, Licensee or its designated Affiliate, Sublicensee or designee. Licensor hereby assigns to Licensee all of its right, title, and interest in and to all Existing Regulatory Documentation (including any existing Regulatory Approvals) with respect to the Licensee Territory, subject to Licensor’s right of access, reference and use of Regulatory Data and Regulatory Documentation pursuant to Section 5.2. Licensor shall assign to Licensee all of its right, title, and interest in and to all Regulatory Documentation (including any existing Regulatory Approvals) for each Collaboration Compound with respect to the Licensee Territory Controlled by Licensor or any of its Affiliates promptly after the exercise by Licensee of its Collaboration Candidate Option with respect to such FDA approvals upon receipt thereofCollaboration Compound. 6.6.2 (iv) Each Party shall provide the other Party with an opportunity to review and comment on all major regulatory filings and documents (including INDs, Drug Approval Applications, labelling supplements, Regulatory Authority meeting requests, and core data sheets) (collectively, “ Major Regulatory Filings ”) in the Territory, and all proposed material actions with respect to any Regulatory Approval in the Territory, for which such Party has responsibility pursuant to Section 3.6.1(i) or (ii), as the case may be (including, in the case of Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. Licensor, the Out-Licensed Territory), prior to submission thereof or the taking of the action. Each Party shall provide access to interim drafts of the Major Regulatory Filings to the other Party via the access methods (such as secure databases) established by the JDC, and the other Party shall provide its comments on the then-current drafts of Major Regulatory Filings or of proposed material actions within [***] ([***]) ([***] ([***]) days for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties. In the event that a Regulatory Authority establishes a response deadline for a Major Regulatory Filing or material action shorter than such [***] ([***]) ([***] ([***]) day) period, the Parties shall work cooperatively to ensure the other Party has a reasonable opportunity for review and comment within such deadlines. Each Party shall, and shall cause its Affiliates, licensees and Sublicensees to, consider in good faith any such comments of the other Party. Neither Party shall, and each Party shall ensure that its Affiliates, licensees (including Kyowa and any other licensees of Licensor with respect to the Out-Licensed Territory), and Sublicensees do not, take any action with respect to any Regulatory Approval (including the filing of any Drug Approval Application) anywhere in its portion of the Territory that could reasonably be expected to have a Material Adverse Effect on the other Party. If the Parties disagree as to whether a particular action could reasonably be expected to have such a Material Adverse Effect, the dispute shall be resolved by the JDC (subject to the dispute resolution procedures set forth in Section 13.6.2). (v) Subject to the terms of the Transition Services Agreement from and after the Closingimmediately following sentence, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller Party shall provide Purchaser the other Party with (iA) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to any Seller Product the Development or Commercialization of Licensed Products received by Seller, such Party or its Affiliates, licensees, sublicensees licensees or distributors Sublicensees from, or submitted forwarded by Seller, such Party or its Affiliates, licensees, sublicensees licensees or distributors Sublicensees to, the Regulatory Authorities; Authorities in the Territory and (iiB) copies of all meeting minutes and other similar summaries of all meetings, conferences conferences, and discussions held by Seller such Party or its Affiliates, licensees or Sublicensees with the Regulatory Authorities to in such Party’s portion of the extent relating to any Seller ProductTerritory, including copies of all contact reports produced by Seller and such Party or its Affiliates, licensees, sublicensees and distributorslicensees or Sublicensees, in each case ((iA) and (iiB)), ) within ten (10) [***] Business Days after Seller’s of its receipt, submission forwarding or production of the foregoing, as applicable. To If such written or electronic correspondence received from a Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval for a Licensed Product, the prohibition or suspension of the supply of a Licensed Product, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety of a Licensed Product, such Party shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable, but not later than one (1) Business Day after receipt of such correspondence. Licensor’s obligations under this Section 3.6.1(v) with respect to the Out-Licensed Territory shall be subject to Licensor’s rights and obligations under the Kyowa Agreement and Licensor’s receipt of Information from Kyowa. (vi) Each Party shall provide the other Party with prior written notice, to the extent applicablethe Party has advance knowledge, Seller shall provide Purchaser a draft of any written response thereto reasonably meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in advance the Licensee Territory (in light the case of Licensee) or the United States (in the case of Licensor) relating to a Licensed Product, within [***] business days after the Party or its Affiliate, licensee or Sublicensee first receives notice of the prevailing circumstancesscheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to attend such meeting, conference, or discussion). The other Party shall have the right to attend as an observer (but not participate in) all such meetings, conferences, and discussions. Specific terms in this Exhibit have been redacted because such terms are both not material and are of submitting the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. (vii) Each Party shall make every reasonable effort to notify the other Party promptly (but in no event later than [***]) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension or market withdrawal of a Licensed Product in such response Party’s portion of the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Each Party (or its licensee or Sublicensee) shall have the right to make the applicable final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in such Party’s portion of the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, the recalling Party shall consult with the other Party and shall consider the other Party’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory AuthoritiesAuthority in a Party’s portion of the Territory, such Party (or its licensee or Sublicensee) shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 3.6.1(vii), the Party (or its licensee or Sublicensee) responsible for the recall, market suspension or market withdrawal shall be solely responsible for the execution thereof, and the other Party shall reasonably cooperate in all such recall efforts. Subject to Article 11, each recalling Party shall be responsible for all of its costs incurred in connection with such conduct.

Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 (a) Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement, Advaccine will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Regulatory Approval of the Products (including the Inovio Device and the Arrays for use in connection with the Products) in the Field in the Advaccine Territory, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for the Products in any Region in the Field in the Advaccine Territory. Advaccine shall be responsible for filing each CTA in the Field in the Advaccine Territory for each Product. Advaccine shall be responsible for filing each MAA in the Field in the Advaccine Territory for each Product in Advaccine’s name. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of the Products in the Field in the Advaccine Territory. Advaccine shall use Commercially Reasonable Efforts to carry out its regulatory obligations for the Products pursuant to such strategy. 6.6.3 Except (b) Inovio shall provide all reasonable assistance and cooperation to Advaccine as Advaccine may reasonably request, at Advaccine’s sole cost and expense, during the Term of this Agreement, with respect to the extent otherwise provided in the Transition Services Agreementsatisfaction of its obligations under Section 5.1(a), from and after the Closing, Seller shall provide Purchaser with including (i) copies in connection with the preparation of all written or electronic correspondence relating to any Seller Product received by SellerRegulatory Materials, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes (A) making available competent personnel to attend regulatory meetings or join such meetings by teleconference and other similar summaries of all meetings, conferences (B) providing documentation within Inovio’s possession and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributorscontrol, in each case ((i) as requested by Regulatory Authorities at Advaccine’s cost, and (ii))iii) providing Advaccine with additional Product Materials in the Inovio Territory as requested by Regulatory Authorities in the Advaccine Territory within a reasonable timeframe commensurate with the volume of Advaccine’s reasonable request. In the event that Inovio believes that such requests are not reasonable or are otherwise burdensome to Inovio, within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller then such matter shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response be promptly submitted to the applicable Regulatory AuthoritiesJSC for review and discussion.

Regulatory Responsibilities. 6.6.1 From and (a) For a period of twelve (12) months after the ClosingClosing Date or until such time as all Products sold by Sellers in the channel prior to Closing have expired, subject Sellers agree to notify Buyer of any information of which they become aware concerning any Adverse Event with respect to any Products. Subject to the terms of the Transition Services Agreement other Transaction Documents, and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary AgreementTransaction Document, Purchaser after the transfer of the Acquired Product Registrations, as applicable, Buyer shall have the sole right and responsibility for (i) taking all actions, paying all fees and conducting all communications with applicable Governmental Authorities with respect to the Acquired Product Registrations, including preparing and filing all reports (including complying with all applicable Adverse Event reporting obligations to any Governmental Authority with respect to the Products and investigating all complaints and Adverse Events with respect to the Products (whether sold before or after Closing)) with applicable Governmental Authorities, (ii) taking all actions and conducting all communications with Third Parties in respect of Products sold pursuant to the Acquired Product Registrations, including responding to all complaints in respect thereof, and (iii) investigating all Adverse Events in respect of Products sold pursuant to the Acquired Product Registrations. (b) From and after Closing, Buyer shall comply with all Laws and obligations applicable to the Products, including: (i) bearing the sole right and responsibility for (and the cost of) preparing, obtaining obtaining, maintaining, and maintaining complying with all obligations and commitments associated with all Regulatory Approvals necessary for the Product BusinessApprovals, and for conducting communications with Governmental Authorities of competent jurisdictionAuthorities, for Seller the Products. Without limitation ; (ii) bearing the sole right and responsibility for (and the cost of) complying with all legal, regulatory, and contractual obligations and responsibilities related to the research and development or Exploitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling Products; (iii) taking all actions and shall comply conducting all communication with such FDA approvals upon receipt thereof. 6.6.2 Subject Third Parties with respect to the terms of the Transition Services Agreement from and Products (whether sold before or after the Closing), Seller shall support Purchaserincluding responding to all complaints and medical information requests; (iv) obtaining all Permits required for the Exploitation of the Products in any country or territory; and (v) complying with FDA registration and listing requirements or analogous requirements of any comparable Governmental Authority. (c) Following the Closing Date, Buyer shall, as may be reasonably necessary and promptly as practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for register with the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser FDA to obtain or maintain such Regulatory Approvalsits own labeler code, in each case, in accordance if necessary; and list with the terms FDA its own NDC numbers with respect to Lioresal and conditions Lyvispah; and to have in place as soon as reasonably practicable all resources such that manufacturing and sales of this Agreement. 6.6.3 Except to Lioresal and Lyvispah can be accomplished under the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller NDC numbers of Buyer. Buyer shall provide Purchaser with be permitted (i) copies to manufacture and label (or have manufactured or labeled) Lioresal using Sellers’ NDC numbers for a period of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; no more than six (6) months following the Closing and (ii) copies to sell and distribute Lioresal using Sellers’ NDC numbers for a period of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to no more than twelve (12) months following the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesClosing.

Regulatory Responsibilities. 6.6.1 From and (a) For so long as Sellers have responsibility for Adverse Event reporting pursuant to the Transition Agreement, Buyer agrees to notify the applicable Seller of any reportable Adverse Event of which it or its Affiliate becomes aware with respect to any Products. On or after the Closing Date, the Parties will enter into a customary safety data exchange agreement addressing the Parties’ respective roles and responsibilities with respect to Adverse Event reporting after Closing, subject to the terms of the Transition Services Agreement Agreement. (b) Subject to the terms of the Transition Agreement, from and except as required by a Party to comply after the Closing Date, Buyer shall be solely responsible, at its sole cost and expense, for complying with applicable Law or to exercise its rights all Laws and obligations hereunder or under any other Ancillary Agreementapplicable to the Products, Purchaser shall have including but not limited to bearing the sole right and responsibility for for: (i) preparing, obtaining obtaining, maintaining, and maintaining complying with all obligations and commitments associated with all Regulatory Approvals necessary for the Product BusinessApprovals, and for conducting communications with Governmental Authorities of competent jurisdictionAuthorities, for Seller the Products. Without limitation ; (ii) complying with all legal, regulatory, and contractual obligations and responsibilities related to the research and development or Exploitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling Products; (iii) taking all actions and shall comply conducting all communication with such FDA approvals upon receipt thereof. 6.6.2 Subject Third Parties with respect to the terms of the Transition Services Agreement from and Products after the Closing, Seller shall support Purchaser, as may be reasonably necessary including responding to all complaints and practicable, at Purchaser’s cost and expense, in preparing, medical information requests; (iv) obtaining and maintaining all Regulatory Approvals Permits required for the Seller Products, including providing necessary documents Exploitation of the Products in any country or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authoritiesterritory; and (iiv) copies complying with FDA registration and listing requirements or analogous requirements of all meeting minutes any comparable Governmental Authority. (c) Following the Closing Date, Buyer shall, as promptly as commercially practicable, register with the FDA to obtain its own labeler code and other similar summaries of all meetings, conferences and discussions held by Seller list with Regulatory Authorities the FDA its own NDC numbers with respect to the extent relating Products and to any Seller Product, including copies have in place as soon as reasonably practicable all resources such that manufacturing and sales can be accomplished under the NDC numbers of all contact reports produced by Seller Buyer. Buyer shall be permitted to sell and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission distribute the Inventory bearing or production using Sellers’ NDC numbers until the earlier of either the marketing end dates of the foregoing, as applicable. To NDC numbers or the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light expiration of the prevailing circumstances) of submitting such response to the applicable Regulatory Authoritiesrelevant Inventory.

Regulatory Responsibilities. 6.6.1 From Subject to Section 3.3(d), and after prior to the Closingtransfer contemplated in Section 3.6(c) below, Protalix shall, subject to Chiesi’s direction and approval (by and through the terms Steering Committee or otherwise), be responsible for implementing all pre-Regulatory Approval regulatory plans and strategies for, and making any regulatory filings in respect of, the Licensed Product in the Field in the Territory (excluding, for the avoidance of doubt, any application to a Regulatory Authority seeking Regulatory Approval, which shall in each case, be in the Transition Services Agreement name of, and except as required by a Party to comply with applicable Law submitted by, Chiesi). Without limiting the foregoing, following the transfer contemplated in Section 3.6(c): (i) Chiesi (or to exercise one or more of its rights designated Affiliates) will own and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility be responsible for preparing, obtaining seeking, and submitting such regulatory filings as are necessary to obtain Regulatory Approval and then maintaining all Regulatory Approvals necessary and any post-approval regulatory filings, for the Licensed Product Businessin the Field in the Territory, including preparing all reports necessary as part of such Regulatory Approvals or post-approval regulatory filings. Protalix shall have the right and be responsible to prepare and promptly submit to Chiesi any non-clinical, clinical and Manufacturing portions (including CMC) of such regulatory filings and any related reports (subject to Chiesi’s approval rights with respect to such regulatory filing as a whole), at Chiesi’s sole cost and expense (unless such costs are Development Costs or other costs expressly addressed hereunder or by a separate agreement between the Parties). Protalix shall consider in good faith any proposed revision reasonably made by Chiesi thereto and Protalix shall otherwise provide such assistance as Chiesi reasonably requires, at Chiesi’s sole cost and expense (unless such costs are Development Costs or other costs expressly addressed hereunder or by a separate agreement between the Parties), to obtain Regulatory Approvals for the Licensed Product in the Field in the Territory. (ii) Following the transfer contemplated in Section 3.6(c), but in any event, no later than the grant of Regulatory Approval, Chiesi shall (A) subject to Section 5.3(e), assume sole responsibility for seeking authorization in respect of, conducting, and for conducting communications otherwise interacting with Governmental Authorities of competent jurisdictionthe FDA in respect of, for Seller Products. Without limitation of any Post-Approval Studies, and (B) have the foregoingright to apply for, promptly following the Closingand secure, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as exclusivity rights that may be available under Law in the Territory, including any Regulatory Exclusivity. Protalix shall reasonably necessary cooperate with Chiesi, and practicabletake such reasonable actions to assist Chiesi, at PurchaserChiesi’s sole cost and expense, in preparingobtaining such exclusivity rights in the Territory, obtaining as Chiesi may reasonably request from time to time. For the avoidance of doubt (A) at all relevant times during the Term, Chiesi shall have the final decision-making authority in respect of all regulatory plans and maintaining all Regulatory Approvals strategies for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided Licensed Product in the Transition Services Agreement, from Field in the Territory; provided that Chiesi shall reasonably consider any comments on such plans and after strategies that Protalix may communicate (through the Closing, Seller shall provide Purchaser with (i) copies of all written Steering Committee or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authoritiesotherwise); and (iiB) copies following Regulatory Approval in the Territory, Chiesi shall be solely responsible for any such activities as are initiated after the date of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with such Regulatory Authorities Approval that would otherwise constitute Development activities had they been initiated prior to the extent relating to any Seller Product, including copies grant of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesApproval.

Regulatory Responsibilities. 6.6.1 From (a) As between the Parties, Licensee will be solely responsible for all regulatory submissions and after exchanges and will direct and control all regulatory activities with respect to Compounds and Products in the ClosingTerritory, subject including responses and correspondence, safety reporting, negotiation, analysis, and strategy. Licensor represents and warrants to the terms Licensee that, as of the Transition Services Agreement Effective Date, there are no Regulatory Materials in Licensor’s possession or under Licensor’s Control related to any Compound or Product. If, during the Term, the Parties become aware of any such Regulatory Materials in Licensor’s possession or under Licensor’s Control, Licensor will, promptly notify Licensee, and at Licensee’s request, promptly transfer all such Regulatory Materials to Licensee. (b) Licensee will be the primary interface with and will otherwise handle all correspondence, meetings, and other interactions with the relevant Regulatory Authorities concerning regulatory or other activities related to Compounds or Products in the Field in the Territory. Licensee will prepare and file any and all Regulatory Materials for each Compound or Product in the Field in the Territory [***]. Licensor will assist and cooperate, in a timely manner, [***], with Licensee in connection with the preparation and filing of such Regulatory Materials, as reasonably requested by Licensee. Such cooperation will include promptly responding within procedural or other timelines set by Regulatory Authorities or any applicable Law to any reasonable request from Licensee for Licensor Know-How or other Information needed for the Regulatory Materials. (c) Unless the Parties otherwise agree in writing: (i) except as required expressly contemplated by a Party this Section 5.1, Licensor will not communicate with respect to comply any Compound or Product in the Field with applicable Law any Regulatory Authority having jurisdiction in the Territory, unless so ordered by such Regulatory Authority, or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory ApprovalsLaw, in each case, which case Licensor will provide prompt (but in accordance with the terms and conditions any event within [***] Business Days) notice to Licensee of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors fromsuch order, or submitted upon realizing such requirement is imposed by SellerLaw, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authoritiesand all details thereof; and (ii) copies of all meeting minutes and other similar summaries of all meetingsexcept as expressly contemplated by this Section 5.1, conferences and discussions held Licensor will not submit any Regulatory Materials or seek Regulatory Approvals by Seller with Regulatory Authorities to or for itself for any Compound or Product in the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, Field in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory AuthoritiesTerritory.

Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 (a) Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except , Licensee shall conduct or cause to be conducted all regulatory activities in the Territory related to the extent otherwise provided Product in the Transition Services AgreementField in its own or its Affiliate’s name under the Localization Paradigm or in the name of Licensor under the Importation Paradigm if Licensee or its Affiliate is not allowed to hold the product registration under its name, from including the preparation of Regulatory Materials and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; communications and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller interactions with Regulatory Authorities in the Territory with respect to the extent same, for the purpose of securing or maintaining all necessary Regulatory Approvals to import the Products, Develop the Products, Manufacture the Products, or Commercialize the Products in the Field in the Territory. Licensee or its Affiliate shall be responsible for all of the costs and expenses in connection with obtaining and maintaining Regulatory Approvals for Products in the Field in the Territory. (b) Licensee shall keep Licensor informed of regulatory developments related to the Products in the Field in the Territory and shall promptly notify Licensor in writing of any decision by any Regulatory Authority in the Territory regarding the Products. (c) Licensee shall provide Licensor with draft of all Regulatory Materials relating to the Product in the Field in the Territory a reasonable time prior to submission for review, and shall consider and implement in good faith all reasonable comments received from Licensor. In addition, Licensee shall notify Licensor of any Seller Product, including Regulatory Materials submitted to or received from any Regulatory Authority in the Territory and shall provide Licensor with copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case thereof within five ((i5) and (ii)), within ten (10) Business Days days after Seller’s receipt, submission or production receipt. If any such Regulatory Materials is not in the English language, Licensee shall also provide Licensor with an English translation of Key Regulatory Materials and an English summary of other Regulatory Materials sufficient for Licensor to understand the contents of such Regulatory Materials. For the purpose of this section, Key Regulatory Materials shall mean those materials set forth in Exhibit G. Licensor shall have the right to review and comment on such Regulatory Materials and Licensee shall take such comment into consideration and incorporate such comment when appropriate. (d) Licensee shall provide Licensor with reasonable advance notice of any meeting or discussion with any Regulatory Authority (or related advisory committees) in the Territory related to the Product in the Field. Licensee shall lead such meeting or discussion, provided however that Licensor or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. Notwithstanding the foregoing, as applicable. To for key meetings or discussions with Regulatory Authorities related to the extent applicableProduct, Seller Licensor or its designee shall provide Purchaser a draft of any written response thereto reasonably in advance (in light attend such meetings at the cost and expenses of the prevailing circumstances) of submitting Licensee if reasonably requested by Licensee. If Licensor is not able to attend such response meeting or discussion due to the applicable Force Majeure or other reasons, Licensee shall promptly provide Licensor with a written English summary of such meeting or discussion. (e) Licensee shall not submit any Regulatory AuthoritiesMaterials or seek Regulatory Approvals for the Product outside the Territory or any indication outside the Field in the Territory and shall not communicate with any Regulatory Authority having jurisdiction outside the Territory, unless so ordered by such Regulatory Authority, in which case Licensee shall immediately notify Licensor of such order and cooperate with Licensor to respond to such order. (f) Licensee shall be solely responsible for providing additional label to ensure safe use of the Product in each Market in the Territory (including adding label in the local language to promote safe use by patient in such Market), and such label must identify Licensee or its Designated Parties (not Licensor) as contact entity for inquiry or complaint regarding the Product. Licensee shall also include clear marking on the Product’s external and internal package to indicate that such Product is not for re-importation into the USA.

Regulatory Responsibilities. 6.6.1 From and after (i) As between the ClosingParties, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser Licensee shall have the sole right and responsibility for preparing, obtaining obtaining, and maintaining all Regulatory Approvals necessary for Drug Approval Applications (including the Product Businesssetting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and for conducting communications with Governmental Authorities of competent jurisdictionthe Regulatory Authorities, for Seller Products. Without limitation Licensed Products in the Licensee Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities with respect to (A) Unilateral Activities of Licensor in the Licensee Territory (provided that Licensor shall reimburse Licensee for its reasonable, fully-burdened costs for conducting such regulatory activities in support of Unilateral Activities of Licensor) and (B) Joint Development Activities). (ii) As between the Parties, Licensor shall have the sole right and responsibility for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the foregoingoverall regulatory strategy therefor), promptly following other regulatory approvals and other submissions, and for conducting communications with the ClosingRegulatory Authorities, Purchaser for Licensed Products in the Licensor Territory (including the Out-Licensed Territory (which shall obtain include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities with respect to (A) Unilateral Activities of Licensee in the Licensor Territory (provided that Licensee shall reimburse Licensor for its reasonable, fully-burdened costs for conducting such FDA approvals as are necessary for Purchaser’s own regulatory activities in support of Unilateral Activities of Licensee) and (B) Joint Development Activities). (iii) All Regulatory Documentation (including Regulatory Approvals and Product labeling Labelling) relating to the Licensed Products with respect to the Licensee Territory shall be owned by, and shall comply be the sole property of, Licensee or its designated Affiliate, Sublicensee or designee. Licensor hereby assigns to Licensee all of its right, title, and interest in and to all Existing Regulatory Documentation (including any existing Regulatory Approvals) with respect to the Licensee Territory, subject to Licensor’s right of access, reference and use of Regulatory Data and Regulatory Documentation pursuant to Section 5.2. Licensor shall assign to Licensee all of its right, title, and interest in and to all Regulatory Documentation (including any existing Regulatory Approvals) for each Collaboration Compound with respect to the Licensee Territory Controlled by Licensor or any of its Affiliates promptly after the exercise by Licensee of its Collaboration Candidate Option with respect to such FDA approvals upon receipt thereofCollaboration Compound. 6.6.2 (iv) Each Party shall provide the other Party with an opportunity to review and comment on all major regulatory filings and documents (including INDs, Drug Approval Applications, labelling supplements, Regulatory Authority meeting requests, and core data sheets) (collectively, “Major Regulatory Filings”) in the Territory, and all proposed material actions with respect to any Regulatory Approval in the Territory, for which such Party has responsibility pursuant to Section 3.6.1(i) or (ii), as the case may be (including, in the case of Licensor, the Out-Licensed Territory), prior to submission thereof or the taking of the action. Each Party shall provide access to interim drafts of the Major Regulatory Filings to the other Party via the access methods (such as secure databases) established by the JDC, and the other Party shall provide its comments on the then-current drafts of Major Regulatory Filings or of proposed material actions within [***] days ([***] days for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties. In the event that a Regulatory Authority establishes a response deadline for a Major Regulatory Filing or material action shorter than such [***] ([***]) day (or [***] ([***]) day) period, the Parties shall work cooperatively to ensure the other Party has a reasonable opportunity for review and comment within such deadlines. Each Party shall, and shall cause its Affiliates, licensees and Sublicensees to, consider in good faith any such comments of the other Party. Neither Party shall, and each Party shall ensure that its Affiliates, licensees (including Kyowa and any other licensees of Licensor with respect to the Out-Licensed Territory), and Sublicensees do not, take any action with respect to any Regulatory Approval (including the filing of any Drug Approval Application) anywhere in its portion of the Territory that could reasonably be expected to have a Material Adverse Effect on the other Party. If the Parties disagree as to whether a particular action could reasonably be expected to have such a Material Adverse Effect, the dispute shall be resolved by the JDC (subject to the dispute resolution procedures set forth in Section 13.6.2). (v) Subject to the terms of the Transition Services Agreement from and after the Closingimmediately following sentence, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller Party shall provide Purchaser the other Party with (iA) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to any Seller Product the Development or Commercialization of Licensed Products received by Seller, such Party or its Affiliates, licensees, sublicensees licensees or distributors Sublicensees from, or submitted forwarded by Seller, such Party or its Affiliates, licensees, sublicensees licensees or distributors Sublicensees to, the Regulatory Authorities; Authorities in the Territory and (iiB) copies of all meeting minutes and other similar summaries of all meetings, conferences conferences, and discussions held by Seller such Party or its Affiliates, licensees or Sublicensees with the Regulatory Authorities to in such Party’s portion of the extent relating to any Seller ProductTerritory, including copies of all contact reports produced by Seller and such Party or its Affiliates, licensees, sublicensees and distributorslicensees or Sublicensees, in each case ((iA) and (iiB)), ) within ten (10) [***] Business Days after Seller’s of its receipt, submission forwarding or production of the foregoing, as applicable. To If such written or electronic correspondence received from a Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval for a Licensed Product, the prohibition or suspension of the supply of a Licensed Product, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety of a Licensed Product, such Party shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable, but not later than one (1) Business Day after receipt of such correspondence. Licensor’s obligations under this Section 3.6.1(v) with respect to the Out-Licensed Territory shall be subject to Licensor’s rights and obligations under the Kyowa Agreement and Licensor’s receipt of Information from Kyowa. (vi) Each Party shall provide the other Party with prior written notice, to the extent applicablethe Party has advance knowledge, Seller shall provide Purchaser a draft of any written response thereto reasonably meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in advance the Licensee Territory (in light the case of Licensee) or the United States (in the case of Licensor) relating to a Licensed Product, within [***] business days after the Party or its Affiliate, licensee or Sublicensee first receives notice of the prevailing circumstancesscheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to attend such meeting, conference, or discussion). The other Party shall have the right to attend as an observer (but not participate in) all such meetings, conferences, and discussions. (vii) Each Party shall make every reasonable effort to notify the other Party promptly (but in no event later than [***]) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension or market withdrawal of submitting a Licensed Product in such response Party’s portion of the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Each Party (or its licensee or Sublicensee) shall have the right to make the applicable final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in such Party’s portion of the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, the recalling Party shall consult with the other Party and shall consider the other Party’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory AuthoritiesAuthority in a Party’s portion of the Territory, such Party (or its licensee or Sublicensee) shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 3.6.1(vii), the Party (or its licensee or Sublicensee) responsible for the recall, market suspension or market withdrawal shall be solely responsible for the execution thereof, and the other Party shall reasonably cooperate in all such recall efforts. Subject to Article 11, each recalling Party shall be responsible for all of its costs incurred in connection with such conduct.

Regulatory Responsibilities. 6.6.1 From 3.4.1 Prior to receipt of Regulatory Approval in the Territory for the Initial Indication for Contrave: (a) Orexigen shall prepare, file, maintain, and own all Regulatory Filings, including the IND and the NDA for Contrave in the Territory, and related submissions with respect to Contrave in the Territory; and (b) Orexigen shall promptly notify Takeda of all material Regulatory Filings with respect to Contrave that it proposes to submit to Regulatory Authorities, or that it receives from Regulatory Authorities, in the Territory (including all substantive correspondence with such Regulatory Authorities, responses from such Regulatory Authorities, requests for information from such Regulatory Authorities, briefing documents and other materials relating to interactions with such Regulatory Authorities, and summaries of outputs resulting from substantive correspondence/conversations or meetings with such Regulatory Authorities), and shall promptly provide Takeda with a copy (which may be wholly or partly in electronic form) of such Regulatory Filings for review by Takeda. Takeda shall provide any comments promptly, but in no event later than three (3) Business Days after receiving such Regulatory Filings, Orexigen shall reasonably consider and give due consideration to any such comments provided by Takeda, and, as necessary, it shall discuss such comments with Takeda, and each Party shall use good faith efforts to mutually agree on the Closingcontent of any communications that relate to or contain commitments made or to be made by Orexigen to Regulatory Authorities for the purpose of obtaining Regulatory Approvals; provided, subject however, (i) Orexigen shall retain the right to make any final decisions with respect to the terms content of any such communications, which shall be compliant with the Transition Services Development Plan, this Agreement and except as required by applicable Law, and (ii) in the event any interaction with a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary AgreementRegulatory Authority is time-sensitive, Purchaser Orexigen shall have the sole right to communicate with such Regulatory Authority within the time frame requested by such Regulatory Authority. Orexigen shall provide Takeda with reasonable advance notice of any scheduled meeting with any Regulatory Authority relating to the Product or any Regulatory Approval in the Territory, and Takeda shall have the right to have up to two (2) individuals attend and participate in any such meeting; provided, however, Orexigen will retain the lead role and responsibility in any such meetings. 3.4.2 The Parties acknowledge and agree that as of the Amended and Restated Effective Date, Orexigen has transferred all Regulatory Filings relating to Contrave in the Territory, including the IND and the NDA for Contrave in the Territory, into the name of Takeda and provided Takeda with a copy of all such Regulatory Filings. Takeda is responsible for (a): preparing, obtaining filing, maintaining and maintaining owning all Regulatory Approvals necessary Filings and related submissions, including the IND and the NDA for Contrave in the Product BusinessTerritory, with respect to Products in all Indications in the Territory, and (b) leading discussions and meetings with all Regulatory Authorities regarding Products in all Indications in the Territory; provided, however, two (2) representatives of Orexigen shall be entitled to participate in any such discussions and meetings with Regulatory Authorities, and, if an appropriate Orexigen representative(s) is requested by Takeda to attend a discussion or meeting with a Regulatory Authority regarding the Products in the Indications in the Territory, Orexigen will use Commercially Reasonable Efforts to arrange for conducting communications such individual(s) to participate in such discussions or meetings. 3.4.3 Upon request, Takeda will provide the JSC with Governmental copies of all Regulatory Filings and related material correspondence submitted to Regulatory Authorities or received from Regulatory Authorities with respect to Products in all Indications in the Territory. Takeda will promptly furnish, but in no event later than five (5) Business Days after receipt or generation, Orexigen with copies of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain all such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply Regulatory Filings (including all substantive correspondence with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement Regulatory Authorities, responses from such Regulatory Authorities, requests for information from such Regulatory Authorities, briefing documents and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser relating to obtain or maintain interactions with such Regulatory ApprovalsAuthorities, in each caseand summaries of outputs resulting from substantive correspondence/conversations or meetings with such Regulatory Authorities). In addition, in accordance with the terms and conditions of this Agreement. 6.6.3 Except prior to making a Regulatory Filing relating to Contrave or responding to any such Regulatory Authority correspondence or interactions, except to the extent otherwise provided impracticable with respect to expedited safety reports, timelines imposed by Regulatory Authorities, Takeda SOPs and other similar time-sensitive issues, Takeda shall provide to the JDC and JSC a complete draft copy for its review and comment. Takeda shall give due consideration to any comments of the JDC and JSC with respect thereto. 3.4.4 Notwithstanding any transfer of Regulatory Filings or ownership thereof to Takeda, Orexigen shall have, on behalf of itself, its Affiliates, and licensees and sublicensees, the right to access and reference data and information contained in any Regulatory Filings to the extent useful or necessary in connection with (a) Product regulatory filings outside the Territory and/or (b) any Clinical Trial of a Product conducted in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written Territory by Orexigen or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, and sublicensees for the Territory or distributors fromfor outside the Territory. Orexigen hereby grants to Takeda, its Affiliates and Sublicensees, the right to access and reference data and information contained in any of Orexigen’s, or submitted by Seller, its Affiliates’, licensees, sublicensees or distributors to, Regulatory Authorities; ’ and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities sublicensees’ Product regulatory filings outside the Territory to the extent relating useful or necessary in connection with Regulatory Filings in or for the Territory. Each Party agrees to provide letters of authorization and take any other actions as reasonably necessary for the other Party to exercise its right to access and reference data and information as permitted under this Section 3.4.4. 3.4.5 If a Regulatory Authority desires to conduct an inspection or audit of, or sends a communication to, Takeda or Orexigen or any Third Party engaged by either Party to perform activities under the Development Plan or Commercialization Plan with regard to any Seller ProductProduct or this Agreement, Takeda and Orexigen each agrees to cooperate with the Regulatory Authority and the other Party during such inspection or audit, including copies by allowing, to the extent practicable, a representative of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case the other Party to be present during the applicable portions of such inspection or audit. Following receipt of the inspection or audit observations of the Regulatory Authority ((i) and (ii)a copy of which the responsible Party will immediately provide to the other Party), the responsible Party will prepare the response to any observation that concerned this Agreement. The other Party agrees to fully cooperate when it prepares such a response, including by providing to the responsible Party, within ten two (102) Business Days after Sellerits request, such information and documentation in the Party’s receiptpossession as may be necessary for the responsible Party to prepare such response. Before submitting the response to the Regulatory Authority, submission or production the responsible Party agrees to give the other Party a reasonable opportunity to comment on it. 3.4.6 Each Party (and its Third Party subcontractors) shall notify the other Party within one (1) Business Day of receipt of notification from a Regulatory Authority of the foregoingintention of such Regulatory Authority to audit or inspect a Party’s facilities with respect to any Product, as applicableincluding facilities being used for Manufacture of any Product. To Each Party (and its Third Party subcontractors) shall also provide the extent applicable, Seller shall provide Purchaser a draft other Party with copies of any written communications received from Regulatory Authorities with respect to such facilities within […***…] ([…***…]) Business Days of receipt. Such Party shall provide the other Party with an opportunity to review and provide input on any proposed response thereto reasonably in advance by such Party (in light of the prevailing circumstancesor Third Party subcontractor) of submitting to such response to the applicable Regulatory Authoritiescommunications.

Regulatory Responsibilities. 6.6.1 From As of the Effective Date, Arrys shall have sole responsibility for and sole decision-making over all regulatory activities and associated costs and expenses for the Licensed Compounds and Licensed Products in the Territory, both before and after obtaining Regulatory Approval. Without limiting the Closingforegoing, subject (a) Arrys shall have sole control over preparing and submitting all Regulatory Materials related to the terms Licensed Compounds and Licensed Products, including all INDs and all applications for Regulatory Approval; (b) Arrys shall own any and all applications for Regulatory Approvals, the Regulatory Approvals, and other Regulatory Materials related to the Licensed Compounds and Licensed Products, which shall be held in the name of Arrys or its designees; (c) the Transition Services Agreement decision whether to file an IND for any particular Licensed Compound or Licensed Product and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser the contents of such IND shall be at Arrys’s sole discretion; (d) Arrys shall have the sole right and responsibility for preparing, obtaining and maintaining to conduct all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller ProductsAuthorities, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, (including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)advisory committee meetings), within ten (10) Business Days after Sellerwith regard to Licensed Compounds and Licensed Products in the Territory; provided that, if Arrys requests that AskAt or its Affiliates interact with a Regulatory Authority, the Parties shall discuss such request in good faith, and if the Parties agree, AskAt shall, at Arrys’s receiptcost, submission engage, or production of the foregoingshall cause its Affiliates to engage, as applicable, in such interaction with such Regulatory Authority. To the extent applicable, Seller Arrys shall provide Purchaser a draft reimburse AskAt for its reasonable and reasonably documented out-of-pocket costs incurred in connection with providing such assistance within [***] of any written response thereto reasonably in advance (in light receipt of the prevailing circumstances) of submitting such response to the applicable Regulatory Authoritiesan invoice from AskAt.