Common use of Regulatory Clause in Contracts

Regulatory. (a) Filings. Between the Effective Date and the date Proof of Concept is established, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted by law). (i) Prior to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in any decision made with respect to a Drug Approval Application, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authority.

Regulatory. 6.1 Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) Filings. Between the Effective Date and JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the date Proof of Concept is established, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible forTerritory to Zai, and Achillion (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to GileadZai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, all Drug Approval Applicationsin each case ((a) or (b)), and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted by law)Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (ia) Prior Zai shall be responsible [***] for all regulatory activities leading up to establishment and including the obtaining of Proof Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of Conceptthe Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, Gilead exclusive, and Achillion authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will collaborate to facilitate regulatory activities. In furtherance of that goalbe the holder of) Regulatory Submissions, Achillion Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly forward provide to Gilead copies NVCR for review and comment drafts of all Drug Approval Applications and communications with and decisions Regulatory Submissions prepared by or on behalf of Regulatory AuthoritiesZai, including English summaries thereof. Gilead NVCR shall have the right to reviewreview and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment upon and participate or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any decision made comments or other correspondences received from a Regulatory Authority with respect to a Drug Approval Application, and will be given Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any in-person meeting or telephonic meetings discussion with any Regulatory Authorities sufficient Authority in the Territory related to permit Gilead’s participation any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meetingsmeeting or discussion. Within ten (10) days of the Effective DateIf NVCR elects not to attend such meeting or discussion, Achillion Zai shall provide Gilead NVCR with copies of any documents and communications described a written summary thereof in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information English promptly following such meeting or assistance that Gilead reasonably requestsdiscussion. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authority.

Regulatory. (a) FilingsZai (either by itself or through its Affiliates and sublicensees) shall have the sole right to apply for and maintain, at its sole discretion and own cost and expense, all Regulatory Approvals of the Products in the Field in the Territory consistent with the Zai Development Plan. Between the Effective Date and the date Proof of Concept is established, Achillion Zai shall be responsible for the preparation of all Regulatory Materials and Zai or its designee shall file and own all Drug Approval Applications. Upon establishment be the holder of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and such Regulatory Approvals in the Territory. (b) ▇▇▇ shall be responsible for all communications and interactions with Regulatory Authorities in relation thereto (with respect to the extent permitted Products in the Field in the Territory, both prior to and subsequent to Regulatory Approval. Unless otherwise required by law)applicable Law, MediLink shall not, and shall cause its Affiliates and Permitted Subcontractors not to, correspond or communicate with Regulatory Authorities regarding any Compound or Product without ▇▇▇’s prior written consent. If MediLink, its Affiliates, or Permitted Subcontractors receive any correspondence or other communication from a Regulatory Authority regarding a Compound or Product, MediLink shall provide Zai with access to or copies of all such correspondence or communication promptly after its receipt. (ic) Prior Zai shall keep MediLink reasonably informed of regulatory developments related to establishment Products in each jurisdiction in the Territory and will promptly notify MediLink in writing of Proof of Conceptany major decision by any Regulatory Authority in the Territory regarding any Product. (d) MediLink shall support Zai as may be requested by ▇▇▇ from time to time in connection with ▇▇▇’s preparation, Gilead submission to Regulatory Authorities and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions maintenance of Regulatory Authorities. Gilead shall have the right Materials, including to reviewobtain or maintain IND and Regulatory Approvals, comment upon for any Compounds and participate in any decision made with respect to a Drug Approval ApplicationProducts, and will be given notice of any in-person or telephonic including attending meetings with Regulatory Authorities sufficient to permit Gileadregarding any Compound or Product upon ▇▇▇’s participation request. Zai will pay MediLink the documented FTE Costs for the FTE hours actually worked by such FTEs after the Effective Date in such meetings. Within ten (10) days performance of the Effective Date, Achillion support to Zai for such regulatory affairs. The calculation method of FTE Costs and the payment mechanism as set forth in Section 3.5(b) shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requestsapply mutatis mutandis. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authority.

Regulatory. (a) Filings. Between The Borrower Parties have made available to Lender all of the Effective Date following documents that Borrower and the date Proof of Concept is established, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities its Subsidiaries have received or possess otherwise in relation thereto (to the extent permitted by law).any form: (i) Prior all material files relating to establishment Regulatory Approvals, regulatory correspondence, written notes in respect of Proof of Concepttelephone communications, Gilead electronic communications and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications material submissions to any active regulatory files regarding preclinical, clinical and communications with manufacturing activities and decisions of any material notices and forms received from Regulatory AuthoritiesAgencies relating to compliance, development (including safety, efficacy and potency), marketing, promotion and manufacturing activities concerning the Included Products; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. Gilead shall have the right to reviewA COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, comment upon and participate in any decision made with respect to a Drug Approval Application, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requestsAS AMENDED. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of all (A) adverse experience reports relating to the extent Included Products and any correspondence, reports or other documents relating thereto; (B) data, information and files included in any database relating to adverse experiences relating to the Included Products; (C) material medical documents relating to the Included Products, including all medical responses, and written contact inquiries; (D) material written complaints and physician and patient inquiries relating to the Included Products; and (E) all manuals, studies and reports and other reference materials used by Borrower and its Subsidiaries in responding to material written complaints and inquiries relating to the Included Products; (iii) material correspondence of any kind (including electronic) or material reports from both internal corporate employees and non-governmental consultants relating to any of the regulatory and/or product liability exposures, marketing and reimbursement strategies, manufacturing (e.g., annual audit reports), and preclinical and clinical data issues concerning any of the Included Products, including any relating to timing of marketing authorization and labeling; (iv) any material information or communication that they would indicate that any Regulatory Agency (A) is not likely to approve, clear or otherwise authorize any application with respect to any of the Included Products; (B) is likely to revise or revoke any current Regulatory Approval granted by any such Regulatory Agency with respect to any of the Included Products; (C) is likely to pursue compliance actions against Borrower or any of its Subsidiaries or any Contract Party, or recall or withdraw any of the Included Products from the applicable market(s); or (D) is likely to pursue any compliance action with respect to manufacture of any Included Product or component thereof; and (v) any and all material reports of inspection observations, establishment inspection reports, warning letters and any other documents received by Borrower or any of its Subsidiaries relating to the Included Products that indicate lack of compliance with any applicable Laws or regulatory requirements by Borrower or any of its Subsidiaries or any Contract Party under any Included License Agreement. (b) There has been no written indication that any Regulatory Agency has any material concerns with any Included Products or may not approve, clear or otherwise authorize the marketing of any Included Products, or revoke, suspend, terminate or modify existing market authorizations for Included Products, and no Person has suffered any material or serious adverse events in any clinical trial or any other test of any Included Product. (c) Borrower and each of its Subsidiaries possess all material Regulatory Approvals issued or required by the appropriate Governmental Authorities that are necessary to conduct their current business relating to the Included Products, including all such Regulatory Approvals required by any Regulatory Agency engaged in the regulation of medical devices, biohazardous substances, controlled substances or materials, and neither Borrower nor any of its Subsidiaries has received any material notice of proceedings relating to, and there are no facts or circumstances known to Borrower or any of its Subsidiaries that would reasonably be expected to lead to, the revocation, suspension, termination or modification of any such Regulatory Approval. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (d) Borrower and each of its Subsidiaries and, to the Knowledge of Borrower, each of the Contract Parties under any Included License Agreement, are in material compliance with, and have materially complied with, all applicable Laws governing its business. Neither Borrower nor any of its Subsidiaries has received any notice citing action or inaction by Borrower or any of its Subsidiaries that would constitute any material non-compliance with any applicable Laws and, to the Knowledge of Borrower, no prospective change in any applicable Law has been adopted that, when made effective, would have a material and adverse effect on the Included Product Payments. (e) Included Products manufactured by or on behalf of Borrower or any of its Subsidiaries are not then adulterated or misbranded within the meaning of the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 351, 352, in Gilead’s possessionany manner that gives rise to any material liability on the part of Borrower or any of its Subsidiaries and are manufactured in all material respects accordance with applicable specifications and all applicable Laws. None of Borrower or any of its Subsidiaries or their respective officers, employees or agents, has been convicted of any crime or debarred, suspended or proposed for debarment or suspension by any Governmental Authority or Regulatory Agency. (f) Schedule 8.24(f) sets forth all Drug material Regulatory Approvals for the Included Products (including the name in which such Regulatory Approval Applicationsis registered) and a list of all countries where files for Regulatory Approvals for the Included Products have been submitted but have not been obtained. The Regulatory Approvals set forth on Schedule 8.24(f) (i) constitute all material and necessary Regulatory Approvals, Informationand applications therefor which Borrower and its Subsidiaries have in connection with the Included Products; and (ii) to the Knowledge of Borrower, dataconstitute all such Regulatory Approvals therefor necessary for the Exploitation of the Included Products as currently conducted and as currently proposed to be conducted in the future in the Initial Forecast by Borrower and its Subsidiaries. All of the Regulatory Approvals set forth on Schedule 8.24(f) are in full force and effect and, to the Knowledge of Borrower, all of the Regulatory Approvals have been duly and validly issued, in each case except as would not be reasonably expected to result in a Material Adverse Effect. (g) The studies, tests and nonclinical and clinical trials conducted by or on behalf of Borrower and its Subsidiaries with respect to the Included Products were, and if still pending are being, conducted in all material respects in accordance with applicable Laws, experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards; any descriptions of the results of such studies, tests and trials provided to Lender are accurate in all material respects; and neither Borrower nor any of its Subsidiaries has received any notices or correspondence from any Governmental Authority, institutional review board or comparable authority requiring the termination, suspension, or material modification or clinical study reports hold of any studies, tests or nonclinical or clinical trials conducted by or on behalf of Borrower or any of its Subsidiaries. No investigator conducting studies, tests and Know-How that is reasonably required for Gilead nonclinical and clinical trials conducted by or on behalf of Borrower and its Subsidiaries with respect to obtain the Included Products have been disqualified by any Governmental Authority or Regulatory Agency. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (h) There has not been any adverse development relating to any Included Product, including with respect to any Regulatory Approval for any Licensed Product. Furtheror Intellectual Property, Gilead shall keep Achillion which would, individually or in the aggregate, reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented be expected to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within result in a reasonable time after their submission to the relevant Regulatory AuthorityMaterial Adverse Effect.

Regulatory. (a) FilingsThe Existing Regulatory Filings constitute all of the Regulatory Approvals with respect to the Lead Compound and the Additional Compound that have been granted to or in the name of any Seller Party or any of their Affiliates on or prior to the Closing Date. Between No Seller Party or Affiliate of any Seller Party has received any written notice from the Effective FDA or any other Governmental Body of, and, to Seller Parties’ Knowledge, there are no circumstances currently existing that would reasonably be expected to lead to, any loss of or refusal to renew any Existing Regulatory Filings or result in an investigation, corrective action or enforcement action by the FDA or any other Governmental Body with respect to the Lead Compound and the Additional Compound. Each of Seller Parties and their Affiliates are in compliance in all material respects with all applicable Laws applicable to the Lead Compound and the Additional Compound and the Transferred Assets during the conduct of the development program for the Lead Compound and the Additional Compound undertaken by Seller Parties and their Affiliates prior to the Closing Date, including the FD&C Act, the Public Health Service Act, the Prescription Drug Marketing Act and regulations issued by the FDA thereunder and all applicable Laws relating to the collection, processing or disclosure of personal data. Neither Seller Parties nor their Affiliates has granted any Third Party any rights of reference or use with respect to any such Governmental Authorizations. Seller Parties have provided to Buyer in the Data Room with true, accurate and complete information, reports and data concerning all scientific studies relating to the Lead Compound and the Additional Compound conducted by Seller Parties and their Affiliates. To the Knowledge of Seller Parties, Seller Parties have provided to Buyer in the Data Room all pre-clinical studies and clinical trial information involving the Lead Compound and the Additional Compound conducted or generated by or on behalf of Seller Parties and their Affiliates, as well as information obtained by Seller Parties from Welichem under the Welichem Agreement with respect to WBI-1001 (provided, however, that any pre-clinical studies and clinical trial information involving the Lead Compound and the Additional Compound generated by or on behalf of Seller Parties and their Affiliates between the Signing Date and the date Proof Closing Date may be provided by means other than the Data Room). Except as has been disclosed in writing to Buyer, to the Knowledge of Concept is establishedSeller Parties no CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Achillion shall be responsible MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. information exists that indicates the existence of any material side effect or adverse effect, resulting from, or alleged to result from the Lead Compound and the Additional Compound. All animal studies and other preclinical tests conducted by Seller Parties or their Affiliates relating to the Lead Compound and the Additional Compound were conducted by or on behalf of Seller Parties or their Affiliates in all material respects in accordance with Seller Parties or their Affiliates’ standard operating procedures for the conduct of animal or preclinical studies at the time such tests were conducted. All human clinical trials conducted by or on behalf of Seller Parties relating to the Lead Compound and shall file the Additional Compound have been and own are being conducted in all Drug Approval Applications. Upon establishment material respects in compliance with the requirements of Proof of Conceptgood clinical practice, Gilead shall become responsible forinformed consent, institutional review boards (as those terms are defined by the FDA or other relevant Regulatory Authorities), and Achillion will transfer other applicable Law relating to Gileadclinical trials or the protection of human subjects, all Drug Approval Applications, in each case as applicable and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities that were in relation thereto (to effect at the extent permitted by law)time such tests were conducted. (ib) Prior to establishment Neither Seller Party nor any of Proof their Affiliates has been subject to, or has been convicted of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate any crime or engaged in any decision made conduct with respect to a Drug Approval Applicationthe Lead Compound and the Additional Compound that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Law, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation (ii) exclusion from participating in such meetings. Within ten (10) days the federal health care programs under Section 1128 of the Effective Date, Achillion shall provide Gilead with copies of Social Security Act or any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requestssimilar Law. (c) Neither Seller Party nor any of their Affiliates has received any: (i) written notice or complaint alleging non-compliance in any material respect with any Law relating to the collection, processing and disclosure of information or data; (ii) The written claim for compensation for loss or unauthorized collection, processing or disclosure of data; or (iii) written notification of an application for rectification, erasure or destruction of information or data that is still outstanding, in each case ((i) through (iii)), in connection with the Lead Compound or the Additional Compound. (d) Seller Parties shallhave documented and stored the Transferred Records and the Transferred Regulatory Documentation in accordance with GSK’s business practices and standards in place for its own programs and products, as soon as practicable after Proof of Concept is establishedin all material respects, cooperate to transfer and provide copies of (to at the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, time such data, protocols, clinical study documents and reports were documented and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authoritystored.

Regulatory. (a) FilingsSeller has made available to Buyer complete and correct copies of (i) all Product INDs and (ii) all Purchased Records. Between All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Effective Date and the date Proof of Concept is established, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted by law)Product IND. (b) With respect to the Purchased Assets, Seller is in compliance with the Act, including the regulations promulgated thereunder, and any state or foreign Laws applicable to the development, testing, safety or efficacy of pharmaceutical products (“Pharmaceutical Laws”), except as would not, individually or in the aggregate, have a Material Adverse Effect. Seller has not received any written, or, to Seller’s Knowledge, other notice from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiating, or threatening to initiate, any action to suspend or terminate a Product IND. In connection with the Purchased Assets, Seller has not and, to the Knowledge of Seller, Seller’s officers, employees, agents or clinical investigators acting for Seller have not (i) Prior made an untrue statement of a material fact or fraudulent statement to establishment the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority or (iii) committed any other act, made any statement or failed to make any statement, that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Proof Material Facts, Bribery, and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policy. (c) Seller has filed with the FDA and other applicable Governmental Authorities all required material filings, declarations, listings, registrations, reports, applications or submissions, including but not limited to Product INDs and adverse event reports, required by Pharmaceutical Laws in connection with the Purchased Assets. All such filings, declarations, listings, registrations, reports, applications or submissions were in material compliance with applicable Pharmaceutical Laws when filed and remain in full force and effect. (d) All preclinical and clinical investigations or trials sponsored by or conducted on behalf of ConceptSeller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, Gilead including Good Clinical Practices requirements thereunder and Achillion will collaborate Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence from the FDA or any other Governmental Authority commencing, or threatening to facilitate regulatory activitiesinitiate, any action to place a clinical hold order on, or to terminate, delay, suspend, or materially modify any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of Seller relating to the Purchased Assets. In furtherance As of that goalthe date of this Agreement, Achillion shall promptly forward there are no ongoing clinical trials or clinical trial commitments related to Gilead copies the Product, other than as set forth on Section 3.7(d) of all Drug Approval Applications and communications with and decisions of Regulatory Authoritiesthe Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Gilead shall have the right to review, comment upon and participate in any decision made Except with respect to a Drug Approval Applicationthe Ongoing Clinical Trials, Seller has completed and will be given notice of any inclosed out all other Gilead-person or telephonic meetings with Regulatory Authorities sufficient sponsored clinical trials related to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requestsProduct. (e) Neither Seller nor, to the Knowledge of Seller, any officer, employee, or agent of Seller has been convicted of any crime or engaged in any conduct in connection with the Purchased Assets that has resulted in or could reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Pharmaceutical Law or (ii) The Parties shallexclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, as soon as practicable after Proof of Concept is establishedactions, cooperate proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to transfer and provide copies of (result in such a material debarment or exclusion that are pending or, to the extent that they are not then in Gilead’s possession) all Drug Approval ApplicationsKnowledge of Seller, Informationthreatened against Seller or any of its respective officers, dataemployees, protocols, agents or clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authorityinvestigators.

Regulatory. (a) To the knowledge of the Company, the Specified Regulatory Filings are current and in full force and effect and include all regulatory filings and governmental registrations made by or issued to the Company that relate specifically to the Specified Technology. The Company has made available to Parent copies of all governmental correspondence (including copies of official notices, citations or decisions) in the Company’s files relating to the Specified Regulatory Filings. Between To the Effective Date and knowledge of the date Proof Company, in the course of Concept is establishedthe clinical development of the Specified Technology, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Conceptthe Company has not used any employee, Gilead shall become responsible forofficer, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto agent or consultant who (at the time such employee or consultant provided services to the extent permitted Company with respect to the Specified Technology) was disbarred by law)the FDA or the subject of pending disbarment proceedings by the FDA. (ib) Prior The Company is in substantial compliance with the laws applicable to establishment the development, manufacture, labeling, testing, subjecting to clinical evaluation and inspection of Proof the Specified Products and with all applicable regulations, policies and procedures promulgated by the FDA with respect thereto. The Company has received no written notice that any recalls, field notifications or seizures have been ordered or, to the knowledge of Conceptthe Company, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in threatened by any decision made governmental body with respect to any of the Specified Products. The Company has not received a Drug Approval Application, and will be given warning letter or other similar written notice from the FDA regarding the Specified Products or the manufacturing facilities used to manufacture the Specified Products. The Company has not received any written notice that the FDA or any other authority has commenced or overtly threatened to initiate any action to enjoin production or clinical evaluation of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetingsSpecified Products. Within ten (10) days To the knowledge of the Effective DateCompany, Achillion shall provide Gilead with copies no officer, employee or agent of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information the Company has made an untrue statement of a material fact or assistance that Gilead reasonably requests. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (fraudulent statement to the extent that they are not then in Gilead’s possession) all Drug Approval ApplicationsFDA or any other authority, Informationor committed an act, datamade a statement or failed to make a statement that, protocolsat the time such disclosure was made, clinical study reports and Know-How that is could reasonably required be expected to provide a basis for Gilead the FDA or any other authority to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented invoke with respect to the Development CommitteeCompany its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory AuthorityIllegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.

Regulatory. (a) FilingsThe Existing Regulatory Filings constitute all of the Regulatory Approvals with respect to the Lead Compound and the Additional Compound that have been granted to or in the name of any Seller Party or any of their Affiliates on or prior to the Closing Date. Between No Seller Party or Affiliate of any Seller Party has received any written notice from the Effective FDA or any other Governmental Body of, and, to Seller Parties’ Knowledge, there are no circumstances currently existing that would reasonably be expected to lead to, any loss of or refusal to renew any Existing Regulatory Filings or result in an investigation, corrective action or enforcement action by the FDA or any other Governmental Body with respect to the Lead Compound and the Additional Compound. Each of Seller Parties and their Affiliates are in compliance in all material respects with all applicable Laws applicable to the Lead Compound and the Additional Compound and the Transferred Assets during the conduct of the development program for the Lead Compound and the Additional Compound undertaken by Seller Parties and their Affiliates prior to the Closing Date, including the FD&C Act, the Public Health Service Act, the Prescription Drug Marketing Act and regulations issued by the FDA thereunder and all applicable Laws relating to the collection, processing or disclosure of personal data. Neither Seller Parties nor their Affiliates has granted any Third Party any rights of reference or use with respect to any such Governmental Authorizations. Seller Parties have provided to Buyer in the Data Room with true, accurate and complete information, reports and data concerning all scientific studies relating to the Lead Compound and the Additional Compound conducted by Seller Parties and their Affiliates. To the Knowledge of Seller Parties, Seller Parties have provided to Buyer in the Data Room all pre-clinical studies and clinical trial information involving the Lead Compound and the Additional Compound conducted or generated by or on behalf of Seller Parties and their Affiliates, as well as information obtained by Seller Parties from Welichem under the Welichem Agreement with respect to WBI-1001 (provided, however, that any pre-clinical studies and clinical trial information involving the Lead Compound and the Additional Compound generated by or on behalf of Seller Parties and their Affiliates between the Signing Date and the date Proof Closing Date may be provided by means other than the Data Room). Except as has been disclosed in writing to Buyer, to the Knowledge of Concept is establishedSeller Parties no Tarpon – Asset Purchase Agreement Strictly Confidential CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Achillion shall be responsible MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. 22 information exists that indicates the existence of any material side effect or adverse effect, resulting from, or alleged to result from the Lead Compound and the Additional Compound. All animal studies and other preclinical tests conducted by Seller Parties or their Affiliates relating to the Lead Compound and the Additional Compound were conducted by or on behalf of Seller Parties or their Affiliates in all material respects in accordance with Seller Parties or their Affiliates’ standard operating procedures for the conduct of animal or preclinical studies at the time such tests were conducted. All human clinical trials conducted by or on behalf of Seller Parties relating to the Lead Compound and shall file the Additional Compound have been and own are being conducted in all Drug Approval Applications. Upon establishment material respects in compliance with the requirements of Proof of Conceptgood clinical practice, Gilead shall become responsible forinformed consent, institutional review boards (as those terms are defined by the FDA or other relevant Regulatory Authorities), and Achillion will transfer other applicable Law relating to Gileadclinical trials or the protection of human subjects, all Drug Approval Applications, in each case as applicable and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities that were in relation thereto (to effect at the extent permitted by law)time such tests were conducted. (ib) Prior to establishment Neither Seller Party nor any of Proof their Affiliates has been subject to, or has been convicted of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate any crime or engaged in any decision made conduct with respect to a Drug Approval Applicationthe Lead Compound and the Additional Compound that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Law, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation (ii) exclusion from participating in such meetings. Within ten (10) days the federal health care programs under Section 1128 of the Effective Date, Achillion shall provide Gilead with copies of Social Security Act or any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requestssimilar Law. (c) Neither Seller Party nor any of their Affiliates has received any: (i) written notice or complaint alleging non-compliance in any material respect with any Law relating to the collection, processing and disclosure of information or data; (ii) The written claim for compensation for loss or unauthorized collection, processing or disclosure of data; or (iii) written notification of an application for rectification, erasure or destruction of information or data that is still outstanding, in each case ((i) through (iii)), in connection with the Lead Compound or the Additional Compound. (d) Seller Parties shallhave documented and stored the Transferred Records and the Transferred Regulatory Documentation in accordance with GSK’s business practices and standards in place for its own programs and products, as soon as practicable after Proof of Concept is establishedin all material respects, cooperate to transfer and provide copies of (to at the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, time such data, protocols, clinical study documents and reports were documented and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authoritystored.

Regulatory. The Company and its Subsidiaries have been and is in compliance in all material respects with applicable Health Care Laws. The Company and its Subsidiaries have filed with the applicable Governmental Entities (aincluding the FDA or any other Governmental Entity performing functions similar to those performed by the FDA) Filingsall required filings, representations, declarations, listings, registrations, reports or submissions. Between To the Effective Date and the date Proof of Concept is establishedCompany’s Knowledge, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Conceptsuch filings, Gilead shall become responsible forrepresentations, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Health Care Laws when filed, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted no material deficiency has been asserted by law). (i) Prior to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in any decision made applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. The business of the Company and its Subsidiaries has been and is in compliance in all material respects with all applicable Health Care Laws. The Company has not received any material written, or to the Company’s Knowledge, oral, notice or other material correspondence from any Governmental Entity, including the FDA or any other Governmental Entity, with respect to any Company Product. There is no pending or, to the Company’s Knowledge, threatened action, suit, claim, order, injunction, investigation or proceeding of any nature pending or threatened, or enforcement of any sort arising under any Health Care Law the FDA or any other Governmental Entity regarding the Company or its Subsidiaries. All Company Products are being and have been developed, manufactured, distributed, used, processed, packaged, labeled, stored and tested in compliance in all material respects with applicable Health Care Law. To the Company’s Knowledge, the Company has not made an untrue statement of a Drug Approval Applicationmaterial fact or fraudulent statement to the FDA or any Governmental Entity responsible for enforcement or oversight with respect to Health Care Laws, or failed to disclose a material fact required to be disclosed to the FDA or other such Governmental Entity. All applications, notifications, submissions, information, claims, reports and statistics and other data that have been utilized, or prepared with the intention to be utilized, as the basis for or submitted in connection with any regulatory or marketing approvals or Permits from the FDA or any other Governmental Entity relating to the Company Products were true, correct and complete in all material respects as of the date of preparation and submission, as applicable, and will be given notice any necessary or required update, change, correction or modification to such applications, submissions, information and data have been submitted to the FDA or other Governmental Entity. The Company has maintained their material regulatory communications, filings and submissions regarding the Company Products in all material respects in a manner reasonably in accordance with industry standards. None of the Company nor any Person(s) engaged by the Company who have performed work related to the Company Products, has been convicted of any in-person crime or telephonic meetings with Regulatory Authorities sufficient is or has been debarred, excluded or disqualified under applicable Health Care Laws, including 21 U.S.C. Section 335a, or, to permit Gileadthe Company’s participation Knowledge has engaged in any conduct that has resulted, or would reasonably be expected to result, in such meetingscriminal conviction or debarment, exclusion or disqualification. Within ten (10To the Company’s Knowledge, no action that would reasonably be expected to result in any such criminal conviction, debarment, exclusion or disqualification are pending or threatened against the Company or any Person(s) days of engaged by the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (Company who have performed work related to the extent that they are not then in Gilead’s possession) all Drug Approval ApplicationsCompany Products, Informationand, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development CommitteeCompany’s Knowledge and the Company, and will provide Achillion copies of all there is no fact that could reasonably requested regulatory filings within a reasonable time after their submission give rise to the relevant Regulatory Authoritysuch an action.

Regulatory. (a) Filings7.4.1 PeerStream acknowledges and agrees that YouNow’s performance of its obligations under this Agreement may be subject to and contingent on the resolution of any regulatory considerations relating to such obligations. Between the Effective Date and the date Proof of Concept is established, Achillion Neither YouNow nor PeerStream shall be liable or responsible to the other, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any terms of the Agreement, when and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted such failure or delay is caused by law)or results from the application of any law or regulation, a change in any law or regulation or any action by any Governmental Authority, based on a reasonable determination by YouNow or PeerStream that any such law or regulation applies. Further, YouNow and PeerStream will work in good faith to address any such regulatory considerations and structure the integration of the PeerStream Apps into the Platform, as well as execute their respective obligations under this Agreement, in a manner that minimizes the regulatory burdens and expenses on the operation of the Platform. 7.4.2 PeerStream covenants and agrees to deliver materials and information necessary for YouNow to obtain all approvals, consents, or qualifications of any Governmental Authority reasonably necessary for the PeerStream Apps to comply with applicable law. Notwithstanding any provisions of this Agreement to the contrary, (i) Prior Peerstream consents to establishment YouNow’s reasonable or required disclosure of Proof of Conceptinformation regarding this Agreement, Gilead the relationship contemplated hereunder, and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate Peerstream Apps in any decision made with respect filings or submissions to a Drug Approval Applicationthe U.S. Securities and Exchange Commission (“SEC”), and will be given notice of including any in-person such YOUNOW MASTER SERVICES AGREEMENT 7 CONFIDENTIAL filings or telephonic meetings with Regulatory Authorities sufficient submissions relating to permit Gilead’s participation in such meetings. Within ten (10) days an offering pursuant to Regulation A of the Effective DateSecurities Act of 1933, Achillion shall provide Gilead as amended (“Regulation A”), or periodic and other reports required to be filed by YouNow with copies of any documents the SEC and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests. (ii) The Parties shallYouNow consents to PeerStream’s reasonable or required disclosure of information regarding this Agreement, as soon as practicable after Proof of Concept is establishedthe relationship contemplated hereunder, cooperate to transfer and provide copies of (the Platform in any filings or submissions to the extent SEC, including periodic and other reports required to be filed by PeerStream with the SEC. 7.4.3 Any alterations that they are YouNow makes to the structuring of the integration of the PeerStream Apps that YouNow deems necessary in order to address regulatory considerations that would restrict the integration of the PeerStream Apps and performance of this Agreement from being consummated, or that would cause performance to be unduly expensive in light of costs and regulatory burdens on YouNow or the Platform, shall be deemed to constitute good faith performance under this Agreement. 7.4.4 While PeerStream may become eligible to receive Props Tokens from the Protocol Rewards Engine in the future, PeerStream acknowledges that this Agreement does not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead contemplate any payments to obtain Regulatory Approval for any Licensed ProductPeerStream from the Protocol Rewards Engine. Further, Gilead shall keep Achillion reasonably apprised PeerStream and YouNow acknowledge and agree that: (i) No money or other consideration is being solicited in connection with any YouNow offering from the Protocol Rewards Engine, and if sent in response, will not be accepted; (ii) No offer to buy Props Tokens can be accepted and no part of any purchase price can be received in connection with any YouNow offering from the progress of all Drug Approval Applications through the progress reports presented Protocol Rewards Engine until an offering statement is qualified pursuant to the Development CommitteeSecurities Act of 1933, and will provide Achillion copies as amended (the “Securities Act”); (iii) Any such offer may be withdrawn or revoked, without obligation or commitment of all reasonably requested regulatory filings within a reasonable any kind, at any time before notice of its acceptance given after their submission to the relevant Regulatory Authority.qualification date; and

Regulatory. 6.1 Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) Filings. Between the Effective Date and JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the date Proof of Concept is established, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible forTerritory to Zai, and Achillion (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to GileadZai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 21 Approval in the Territory submitted by Zai, all Drug Approval Applicationsin each case ((a) or (b)), and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted by law)Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (ia) Prior Zai shall be responsible [***] for all regulatory activities leading up to establishment and including the obtaining of Proof Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of Conceptthe Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, Gilead exclusive, and Achillion authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will collaborate to facilitate regulatory activities. In furtherance of that goalbe the holder of) Regulatory Submissions, Achillion Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly forward provide to Gilead copies NVCR for review and comment drafts of all Drug Approval Applications and communications with and decisions Regulatory Submissions prepared by or on behalf of Regulatory AuthoritiesZai, including English summaries thereof. Gilead NVCR shall have the right to reviewreview and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment upon and participate or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any decision made comments or other correspondences received from a Regulatory Authority with respect to a Drug Approval Application, and will be given Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any in-person meeting or telephonic meetings discussion with any Regulatory Authorities sufficient Authority in the Territory related to permit Gilead’s participation any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meetingsmeeting or discussion. Within ten (10) days of the Effective DateIf NVCR elects not to attend such meeting or discussion, Achillion Zai shall provide Gilead NVCR with copies of any documents and communications described a written summary thereof in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information English promptly following such meeting or assistance that Gilead reasonably requests. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Productdiscussion. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authority.THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 22

Regulatory. (a) Filings. Between the Effective Date and the date Proof of Concept is established, Achillion Licensee shall be responsible for all regulatory activities related to the development and commercialization of the Product in the Field in the Territory, at Licensee’s own cost and expense. Licensee shall prepare and file all Regulatory Materials necessary to obtain and own all Drug maintain the Regulatory Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications the Product in the Field in the Territory and shall be responsible for all communications communication and interaction with Regulatory Authorities with respect thereto. (b) At Licensee’s request and expense, Licensor shall provide Licensee with reasonable assistance in relation thereto connection with the regulatory activities for the Product in the Field in the Territory. Licensor shall provide Licensee access to all material preclinical and clinical data, results, communications and other information Controlled by Licensor and relating to or resulting from any of Licensor’s clinical trials or regulatory filings relating to the Licensed Virus in the Field (the “Licensor Data”) for use by Licensee in obtaining Regulatory Approval for the Product in the Field in the Territory, and Licensee shall have a right of access, a right of reference and a right to use and incorporate all such Licensor Data for purposes of obtaining Regulatory Approval of the Product in the Field in the Territory. (c) Licensee shall provide Licensor with drafts of all Regulatory Materials relating to the Product a reasonable time prior to submission for review and comment, and shall consider and implement in good faith any comments received from Licensor. Without limiting the foregoing, upon Licensor’s request, Licensee shall remove from such Regulatory Materials any information that Licensor reasonably believes would materially and adversely affect the development or commercialization of any Therapeutic Virus outside the Field, to the extent permitted allowed by law). (i) Prior to establishment of Proof of Concept, Gilead applicable laws and Achillion will collaborate to facilitate regulatory activitiesregulations. In furtherance of that goaladdition, Achillion Licensee shall promptly forward to Gilead provide Licensor with copies of all Drug Approval Applications and communications with and decisions of any Regulatory Authorities. Gilead shall have Materials relating to the right Product submitted to review, comment upon and participate or received from any Regulatory Authority in any decision made with respect to a Drug Approval Application, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within the Territory within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possessionafter submission or receipt, and shall provide Gilead notify Licensor of any other material communication relating to the Product with any additional relevant information or assistance that Gilead reasonably requestsRegulatory Authority in the Territory within ten (10) days after such communication. (iid) If any Regulatory Exclusivity is available for any Product in any country or jurisdiction, Licensee shall, at its own cost and expense, use Commercially Reasonable Efforts to seek and maintain such Regulatory Exclusivity protection for such Product. If Licensee does not seek or maintain such Regulatory Exclusivity protection, then Licensor shall have the right (but not the obligation) to do so at Licensor’s own cost and expense; provided that if Licensor successfully obtains such Regulatory Exclusivity protection, Licensee shall reimburse Licensor for all cost and expense incurred. (e) Licensee shall keep Licensor informed with respect to any adverse event or safety issues relating to the development or commercialization of the Product in the Field in the Territory. The Parties may enter into a pharmacovigilance agreement setting forth the procedures for the reporting of adverse event or safety issues of the Product in order for the Parties to comply with its reporting obligations under applicable Laws. (f) Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Product may be subject to any recall, corrective action or other regulatory action by any Regulatory Authority (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Licensee shall be responsible for all Remedial Actions for the Product in the Field in the Territory, including the decision to commence such Remedial Action, and shall bear all cost and expense thereof. Licensee shall, as soon as practicable after Proof of Concept is establishedand shall ensure that its Affiliates and sublicensees will, cooperate maintain adequate records to transfer permit Licensee to trace the distribution, sale and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised use of the progress of all Drug Approval Applications through Product in the progress reports presented to Field in the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory AuthorityTerritory.

Regulatory. B.1 At E*TRADE locations, Broadridge shall use its commercially reasonable efforts to ensure that Broadridge employees, subcontractors, contractors, consultants or other similar third parties or personnel under the control of Broadridge (acollectively, “Broadridge Personnel”), will comply with all E*TRADE policies and procedures, including, but not limited to, security procedures, information security requirements, rules, regulations, policies, holiday and similar schedules (“E*TRADE Policies”) Filings. Between the Effective Date which have been provided to Broadridge and the date Proof Broadridge Personnel in writing. Such E*TRADE Policies are subject to change at E*TRADE’s sole discretion at anytime, but such change must be communicated in writing to Broadridge and the Broadridge Personnel. Broadridge shall use its commercially reasonable efforts to minimize any disruption to E*TRADE’s normal business operations in performing the Services. B.2 Broadridge acknowledges that all Broadridge Personnel will comply with Broadridge’s information security policy (or if applicable, E*TRADE’s information security policy if any Broadridge Personnel is on E*TRADE’s premises, so long as such policy has been provided in writing to such Personnel). Further, Broadridge agrees that certain Broadridge Personnel, as determined by E*TRADE and Broadridge jointly, shall complete information security awareness training reasonably acceptable to E*TRADE. B.3 Broadridge acknowledges and understands that E*TRADE (any of Concept its parent, subsidiaries and Affiliates) is establishedsubject to examination and oversight by various federal and state regulators and governmental administrative agencies, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment including, without limitation, the Office of Proof the Comptroller of Concept, Gilead shall become responsible forthe Currency, and Achillion will transfer that by entering into this Schedule with E*TRADE, Broadridge may be subject to Gileadexamination and oversight by such regulators and agencies. Broadridge hereby agrees, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted by law). (i) Prior to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in any decision made with respect to a Drug Approval Application, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (but solely to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented such examination relates to the Development CommitteeServices provided by Broadridge to E*TRADE hereunder, to submit to and reasonably cooperate in any such examination, at E*TRADE’s expense, and will provide Achillion copies oversight proceeding or in E*TRADE’s efforts to respond to any audit, inquiry or review, whether formal or informal, which may include, but may not be limited to, granting E*TRADE or federal or state regulatory authorities access to Broadridge’s: (i) overviews of all reasonably its disaster recovery and business continuity plans; (ii) disaster *** Confidential treatment has been requested regulatory filings within a reasonable time after their submission for the redacted portions. The Confidential Information redacted has been filed separately with the Securities and Exchange Commission. recovery test results; (iii) an overview of Broadridge’s information security program, (iv) books and records; and (v) facilities, systems, and equipment on supervised visits and without actual access to the relevant Regulatory AuthorityBroadridge’s systems.

Regulatory. The Parties agree to collaborate in the efforts required to obtain and maintain the necessary Regulatory Approvals for a Product developed for an Indication pursuant to the Development Plan. The Parties jointly will create a common registration dossier, which shall include a “common technical document” (“CTD”) meeting applicable Legal Requirements and containing all applicable data generated through performance of the Development Plan for an Indication, which shall serve as a basis for all regulatory filings in each country or region worldwide. The Parties agree to use commercially reasonable best efforts to draft the common technical document so as to be acceptable to both the EMEA and FDA. The Parties further agree that: (a) Filings. Between Osiris will be the Effective Date sponsor of pre-clinical and clinical trials of a Product for an Indication in the date Proof of Concept is established, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications Osiris Territory and shall be responsible for all communications holding and managing the IND, but shall reasonably consult with Regulatory Authorities in relation thereto (to the extent permitted by law).Genzyme on strategic planning matters related thereto; (ib) Prior Genzyme will be Osiris’s legal representative within the meaning of Directive 2001/20/EC of pre-clinical and clinical trials of a Product for an Indication in the Genzyme Territory and shall be responsible for holding and managing all regulatory filings, but shall reasonably consult with Osiris on strategic planning matters related thereto; (c) Osiris will be responsible for filing the BLA and CTD supporting marketing authorization for a Product for an Indication with the appropriate Regulatory Agencies in the Osiris Territory; but shall reasonably consult with Genzyme on strategic planning matters related to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activitiessuch filings. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead Osiris shall have the right to review, comment upon and participate in any decision made with respect use all data related to a Drug Approval ApplicationProduct for an Indication, to reference the CTD and to incorporate by reference any and all parts of regulatory submissions made by Genzyme for any Indication; (d) Genzyme will be given notice responsible for filing the BLA and CTD supporting marketing authorization for a Product for an Indication with the appropriate Regulatory Agencies in the Genzyme Territory, but shall reasonably consult with Osiris on strategic planning matters related to such filings. Genzyme shall have the right to use all data related to a Product for an Indication, to reference the CTD and to incorporate by reference any and all parts of regulatory submissions made by Osiris for any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests.Indication; (iie) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer shall be jointly involved in the strategic planning and provide copies of (to in the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress review of all Drug Approval Applications through written and meeting related regulatory communications concerning the progress reports presented to the Development CommitteeProducts. For clarity, and will provide Achillion copies this shall not include review of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory AuthoritySAE reporting, which is governed by Section 4.

Regulatory. (a) FilingsRegulatory Responsibilities of Clearside. Between Prior to the Effective Date and the date Proof of Concept is establishedXIPERE NDA Approval Date, Achillion Clearside shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be solely responsible for all communications regulatory activities and all interactions with Regulatory Authorities in relation thereto (necessary to the extent permitted by law). (i) Prior to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug obtain Regulatory Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in any decision made with respect to a Drug Approval Application, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described XIPERE Product in this Section 3.4(a)(i) then in Achillion’s possession, the United States and shall provide Gilead bear all costs and expenses relating thereto, including in connection with any additional relevant information or assistance that Gilead reasonably requests. the items set out in Exhibit 5.1 (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead “Additional Clearside Regulatory Matters”). Clearside shall use Commercially Reasonable Efforts to obtain Regulatory Approval for the XIPERE Product in the United States. Clearside shall (a) promptly provide Bausch Health with copies of any Licensed communications which Clearside receives from the applicable Regulatory Authority concerning the XIPERE Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will (b) provide Achillion Bausch Health with draft copies of all reasonably requested regulatory filings within proposed communications from Clearside to the applicable Regulatory Authority with respect to the XIPERE Product (including any Additional Clearside Regulatory Matters ) prior to Clearside’s submission thereof, and (c) permit Bausch Health with a reasonable period of time after their submission to review and comment on such communications and Clearside shall consider in good faith any such reasonable comments, provided that Clearside shall not submit any such communications to the relevant Regulatory AuthorityAuthority without the prior consent of Bausch Health, such consent not to be unreasonably withheld (for greater certainty, if Clearside incorporates any and all comments received from Bausch Health into such communications, then Bausch Health shall be deemed to have provided such prior written consent). Clearside shall promptly (and in any event within [***]) inform Bausch Health of any material regulatory developments with respect to the XIPERE Product in the Territory that may negatively affect the timeline for the First Commercial Sale of the XIPERE Product in the Territory and shall promptly respond to Bausch Health’s reasonable questions or requests for information relating thereto. In addition, within [***] following the end of each calendar quarter until the XIPERE NDA Approval Date, Clearside shall provide a written report to Bausch Health setting forth in reasonable detail the status of its then-current regulatory activities in relation to the XIPERE Product in the Territory. Clearside shall promptly respond to Bausch Health’s reasonable questions or requests for information relating to any such written report.

Regulatory. The Company has been and is in compliance in all material respects with applicable Health Care Laws. The Company has filed with the applicable Governmental Entities (aincluding the FDA or any other Governmental Entity performing functions similar to those performed by the FDA) Filingsall required filings, representations, declarations, listings, registrations, reports or submissions. Between To the Effective Date and the date Proof of Concept is establishedCompany’s Knowledge, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Conceptsuch filings, Gilead shall become responsible forrepresentations, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Health Care Laws when filed, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted no material deficiency has been asserted by law). (i) Prior to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in any decision made applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. The business of the Company has been and is in compliance in all material respects with all applicable Health Care Laws. The Company has not received any material written, or to the Company’s Knowledge, oral, notice or other material correspondence from any Governmental Entity, including the FDA or any other Governmental Entity, with respect to any Company Product. There is no pending or, to the Company’s Knowledge, threatened action, suit, claim, order, injunction, investigation or proceeding of any nature pending or threatened, or enforcement of any sort arising under any Health Care Law the FDA or any other Governmental Entity regarding the Company. All Company Products are being and have been developed, manufactured, distributed, used, processed, packaged, labeled, stored and tested in compliance in all material respects with applicable Health Care Law. To the Company’s Knowledge, the Company has not made an untrue statement of a Drug Approval Applicationmaterial fact or fraudulent statement to the FDA or any Governmental Entity responsible for enforcement or oversight with respect to Health Care Laws, or failed to disclose a material fact required to be disclosed to the FDA or other such Governmental Entity. All applications, notifications, submissions, information, claims, reports and statistics and other data that have been utilized, or prepared with the intention to be utilized, as the basis for or submitted in connection with any regulatory or marketing approvals or Permits from the FDA or any other Governmental Entity relating to the Company Products were true, correct and complete in all material respects as of the date of preparation and submission, as applicable, and will be given notice any necessary or required update, change, correction or modification to such applications, submissions, information and data have been submitted to the FDA or other Governmental Entity. The Company has maintained their material regulatory communications, filings and submissions regarding the Company Products in all material respects in a manner reasonably in accordance with industry standards. None of the Company nor any Person(s) engaged by the Company who have performed work related to the Company Products, has been convicted of any in-person crime or telephonic meetings with Regulatory Authorities sufficient is or has been debarred, excluded or disqualified under applicable Health Care Laws, including 21 U.S.C. Section 335a, or, to permit Gileadthe Company’s participation Knowledge has engaged in any conduct that has resulted, or would reasonably be expected to result, in such meetingscriminal conviction or debarment, exclusion or disqualification. Within ten (10To the Company’s Knowledge, no action that would reasonably be expected to result in any such criminal conviction, debarment, exclusion or disqualification are pending or threatened against the Company or any Person(s) days of engaged by the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (Company who have performed work related to the extent that they are not then in Gilead’s possession) all Drug Approval ApplicationsCompany Products, Informationand, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development CommitteeCompany’s Knowledge and the Company, and will provide Achillion copies of all there is no fact that could reasonably requested regulatory filings within a reasonable time after their submission give rise to the relevant Regulatory Authoritysuch an action.

Regulatory. 11.1. Data Critical's non-integrated StatView system is currently being sold pursuant to Section 510-(k) clearance from the FDA. Data Critical will aid Agilent in developing a separate Agilent FDA (aor any equivalent foreign medical regulatory body) Filingssubmission for medical clearance for the Integrated StatView Product portion of their integrated monitoring device, including aid in providing product-testing data. Between Notwithstanding the Effective Date foregoing, Agilent acknowledges and agrees that it shall be solely responsible for attaining and maintaining all regulatory compliance for the Integrated StatView Product and the date Proof related hardware (including the receivers and transmitters). Data Critical agrees to aid Agilent in the event of Concept is establisheda FDA (or equivalent foreign medical regulatory agency) recall or other product failure issues relating to the Integrated StatView Product or Data Critical's proprietary receivers. In addition Data Critical will aid Agilent, Achillion as reasonably requested, with post market surveillance information and related Medical Device Records relating to the Integrated StatView Product and/or such receivers. Agilent will provide Data Critical with any FDA (or equivalent foreign medical regulatory agency) or customer failure/safety information relating to the Integrated StatView Product or the receivers used in connection therewith on a timely basis. Notwithstanding anything contained herein to the contrary, Agilent shall be responsible provide and make available all information obtained or prepared by or for and shall file and own all Drug Approval Applications. Upon establishment Agilent in connection with Agilent's application for medical regulatory clearance of Proof of Concept, Gilead shall become responsible forthe Integrated StatView Product abroad, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted by law). (i) Prior to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead Data Critical shall have the right to reviewuse such information for the purpose of seeking FDA, comment upon and participate in any decision made with respect to a Drug Approval Application, and will be given notice of any in-person FCC (or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation similar foreign) regulatory clearance in such meetings. Within ten (10) days countries of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance its products; provided that Gilead reasonably requests. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (-------- to the extent any such information consists of specific patient information, such information shall be provided by Agilent only to the extent, and in such form, as shall in either case, be permitted pursuant to any applicable law. 11.2. Data Critical will immediately give notice to Agilent if any upgrade, substitution or other change to an Integrated StatView Product or the related transmitters or receivers is required to make that they product meet applicable safety standards or other governmental statutes, rules, orders or regulations that are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised effect as of the progress date of all Drug Approval Applications through this agreement in the progress reports presented United States. All affected Integrated StatView Products, transmitters or receivers already purchased by Agilent may, at Agilent's election, either be returned to Data Critical for upgrade to current revisions or upgraded by Agilent in the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authorityfield.

Regulatory. 6.1 Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) Filings. Between the Effective Date and JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the date Proof of Concept is established, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible forTerritory to Zai, and Achillion (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to GileadZai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, all Drug MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 21 Approval Applicationsin the Territory submitted by Zai, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto each case ((a) or (b)), to the extent permitted by law)Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (ia) Prior Zai shall be responsible [***] for all regulatory activities leading up to establishment and including the obtaining of Proof Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of Conceptthe Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, Gilead exclusive, and Achillion authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will collaborate to facilitate regulatory activities. In furtherance of that goalbe the holder of) Regulatory Submissions, Achillion Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly forward provide to Gilead copies NVCR for review and comment drafts of all Drug Approval Applications and communications with and decisions Regulatory Submissions prepared by or on behalf of Regulatory AuthoritiesZai, including English summaries thereof. Gilead NVCR shall have the right to reviewreview and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment upon and participate or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any decision made comments or other correspondences received from a Regulatory Authority with respect to a Drug Approval Application, and will be given Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any in-person meeting or telephonic meetings discussion with any Regulatory Authorities sufficient Authority in the Territory related to permit Gilead’s participation any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meetingsmeeting or discussion. Within ten (10) days of the Effective DateIf NVCR elects not to attend such meeting or discussion, Achillion Zai shall provide Gilead NVCR with copies of any documents and communications described a written summary thereof in this Section 3.4(a)(iEnglish promptly following such meeting or discussion. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests. NOT MATERIAL AND (iiII) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed ProductWOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authority.22

Regulatory. Until the Closing, without limiting Sections 7.11 to 7.13: (a) Filings. Between the Effective Date and the date Proof of Concept is established, Achillion Equillium shall be responsible for the preparation of all Regulatory Materials necessary or desirable for the performance of the Program, including to the extent contemplated by the Development Plan, and obtaining and maintaining Regulatory Approvals for each Product. Equillium shall use Commercially Reasonable Efforts to submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in accordance with the time frames set forth in the Development Plan. For clarity, to the extent allowed by applicable Laws, all Regulatory Materials shall be held and owned by Equillium in its name. Equillium shall keep ▇▇▇ reasonably informed regarding meetings and material communications with Regulatory Authorities regarding any Product. (b) Equillium shall, and shall file cause each of its Subsidiaries to, maintain, or cause to be maintained, current and own accurate records of all Drug Approval ApplicationsRegulatory Materials and regulatory data that such parties may acquire for a period covering, at a minimum, the Record Retention Period. Upon establishment In addition, Equillium shall keep Ono reasonably and regularly informed in connection with the preparation of Proof all Regulatory Materials, Regulatory Authority review of Concept, Gilead shall become responsible forRegulatory Materials, and Achillion will transfer Regulatory Approvals, in each case with respect to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and any Product. (c) Equillium shall be responsible for all communications complying with Regulatory Authorities pharmacovigilance obligations under applicable Laws in relation thereto (to connection with the extent permitted by law)Program and each Product. (d) Equillium shall promptly inform ▇▇▇ of notification of any action by, or notification or other information which it receives (directly or indirectly) from, any Regulatory Authority which (i) Prior raises any material concerns regarding the safety or efficacy of any Product, (ii) is reasonably likely to establishment of Proof of Conceptlead to a recall, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in any decision made market withdrawal or market notification with respect to a Drug Approval Application, any Product or (iii) relates to expedited and will be given notice periodic reports of adverse events with respect to any in-person or telephonic meetings with Product which may have an adverse impact on any Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requestsApproval. (iie) The Parties shallIf Equillium believes or determines in good faith that conducting or continuing a clinical trial under the Development Plan poses an unacceptable risk to patient / subject safety or is futile, as soon as practicable after Proof or that the suspension or termination of Concept is establishedany such clinical trial, cooperate to transfer and provide copies of (or a deviation from or amendment to the extent that they are not then protocol of any such clinical trial, is in Gilead’s possession) all Drug Approval Applicationsthe best interest of patients / subjects, Informationor if any Regulatory Authority imposes a hold on, dataor requires or recommends the suspension or termination of, protocolsany such clinical trial, clinical study reports and Know-How that is reasonably required for Gilead then, in each case, Equillium shall promptly inform ▇▇▇ thereof. Notwithstanding anything in this Agreement to obtain Regulatory Approval for the contrary, with respect to any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress events described in the preceding sentence or under similar circumstances 281923888 v10 affecting patient / subject safety or compliance with applicable Laws or Regulatory Authority actions, until the Closing, Equillium shall have final decision-making authority on (and notify ▇▇▇ with respect to such decision) whether to take such actions (including termination or suspension of all Drug Approval Applications through a clinical trial or deviation from, or amendment to, the progress reports presented to protocol for a clinical trial) as it determines in good faith are necessary, appropriate or advisable and consistent with the Development Committeebest interest of patients / subjects or required by applicable Law, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authorityincluding GCP.

Regulatory. (a) FilingsThe Existing Regulatory Filings constitute all of the Regulatory Approvals with respect to the Lead Compound and the Additional Compound that have been granted to or in the name of any Seller Party or any of their Affiliates on or prior to the Closing Date. Between No Seller Party or Affiliate of any Seller Party has received any written notice from the Effective FDA or any other Governmental Body of, and, to Seller Parties’ Knowledge, there are no circumstances currently existing that would reasonably be expected to lead to, any loss of or refusal to renew any Existing Regulatory Filings or result in an investigation, corrective action or enforcement action by the FDA or any other Governmental Body with respect to the Lead Compound and the Additional Compound. Each of Seller Parties and their Affiliates are in compliance in all material respects with all applicable Laws applicable to the Lead Compound and the Additional Compound and the Transferred Assets during the conduct of the development program for the Lead Compound and the Additional Compound undertaken by Seller Parties and their Affiliates prior to the Closing Date, including the FD&C Act, the Public Health Service Act, the Prescription Drug Marketing Act and regulations issued by the FDA thereunder and all applicable Laws relating to the collection, processing or disclosure of personal data. Neither Seller Parties nor their Affiliates has granted any Third Party any rights of reference or use with respect to any such Governmental Authorizations. Seller Parties have provided to Buyer in the Data Room with true, accurate and complete information, reports and data concerning all scientific studies relating to the Lead Compound and the Additional Compound conducted by Seller Parties and their Affiliates. To the Knowledge of Seller Parties, Seller Parties have provided to Buyer in the Data Room all pre-clinical studies and clinical trial information involving the Lead Compound and the Additional Compound conducted or generated by or on behalf of Seller Parties and their Affiliates, as well as information obtained by Seller Parties from Welichem under the Welichem Agreement with respect to WBI-1001 (provided, however, that any pre-clinical studies and clinical trial information involving the Lead Compound and the Additional Compound generated by or on behalf of Seller Parties and their Affiliates between the Signing Date and the date Proof Closing Date may be provided by means other than the Data Room). Except as has been disclosed in writing to Buyer, to the Knowledge of Concept is establishedSeller Parties no [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Achillion shall be responsible MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. information exists that indicates the existence of any material side effect or adverse effect, resulting from, or alleged to result from the Lead Compound and the Additional Compound. All animal studies and other preclinical tests conducted by Seller Parties or their Affiliates relating to the Lead Compound and the Additional Compound were conducted by or on behalf of Seller Parties or their Affiliates in all material respects in accordance with Seller Parties or their Affiliates’ standard operating procedures for the conduct of animal or preclinical studies at the time such tests were conducted. All human clinical trials conducted by or on behalf of Seller Parties relating to the Lead Compound and shall file the Additional Compound have been and own are being conducted in all Drug Approval Applications. Upon establishment material respects in compliance with the requirements of Proof of Conceptgood clinical practice, Gilead shall become responsible forinformed consent, institutional review boards (as those terms are defined by the FDA or other relevant Regulatory Authorities), and Achillion will transfer other applicable Law relating to Gileadclinical trials or the protection of human subjects, all Drug Approval Applications, in each case as applicable and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities that were in relation thereto (to effect at the extent permitted by law)time such tests were conducted. (ib) Prior to establishment Neither Seller Party nor any of Proof their Affiliates has been subject to, or has been convicted of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate any crime or engaged in any decision made conduct with respect to a Drug Approval Applicationthe Lead Compound and the Additional Compound that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Law, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation (ii) exclusion from participating in such meetings. Within ten (10) days the federal health care programs under Section 1128 of the Effective Date, Achillion shall provide Gilead with copies of Social Security Act or any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requestssimilar Law. (c) Neither Seller Party nor any of their Affiliates has received any: (i) written notice or complaint alleging non-compliance in any material respect with any Law relating to the collection, processing and disclosure of information or data; (ii) The written claim for compensation for loss or unauthorized collection, processing or disclosure of data; or (iii) written notification of an application for rectification, erasure or destruction of information or data that is still outstanding, in each case ((i) through (iii)), in connection with the Lead Compound or the Additional Compound. (d) Seller Parties shallhave documented and stored the Transferred Records and the Transferred Regulatory Documentation in accordance with GSK’s business practices and standards in place for its own programs and products, as soon as practicable after Proof of Concept is establishedin all material respects, cooperate to transfer and provide copies of (to at the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, time such data, protocols, clinical study documents and reports were documented and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authoritystored.

Regulatory. (a) Filings7.4.1 PeerStream acknowledges and agrees that YouNow’s performance of its obligations under this Agreement may be subject to and contingent on the resolution of any regulatory considerations relating to such obligations. Between the Effective Date and the date Proof of Concept is established, Achillion Neither YouNow nor PeerStream shall be liable or responsible to the other, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any terms of the Agreement, when and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted such failure or delay is caused by law)or results from the application of any law or regulation, a change in any law or regulation or any action by any Governmental Authority, based on a reasonable determination by YouNow or PeerStream that any such law or regulation applies. Further, YouNow and PeerStream will work in good faith to address any such regulatory considerations and structure the integration of the PeerStream Apps into the Platform, as well as execute their respective obligations under this Agreement, in a manner that minimizes the regulatory burdens and expenses on the operation of the Platform. 7.4.2 PeerStream covenants and agrees to deliver materials and information necessary for YouNow to obtain all approvals, consents, or qualifications of any Governmental Authority reasonably necessary for the PeerStream Apps to comply with applicable law. Notwithstanding any provisions of this Agreement to YOUNOW MASTER SERVICES AGREEMENT 6 CONFIDENTIAL the contrary, (i) Prior Peerstream consents to establishment YouNow’s reasonable or required disclosure of Proof of Conceptinformation regarding this Agreement, Gilead the relationship contemplated hereunder, and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate Peerstream Apps in any decision made with respect filings or submissions to a Drug Approval Applicationthe U.S. Securities and Exchange Commission (“SEC”), and will be given notice of including any in-person such filings or telephonic meetings with Regulatory Authorities sufficient submissions relating to permit Gilead’s participation in such meetings. Within ten (10) days an offering pursuant to Regulation A of the Effective DateSecurities Act of 1933, Achillion shall provide Gilead as amended (“Regulation A”), or periodic and other reports required to be filed by YouNow with copies of any documents the SEC and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests. (ii) The Parties shallYouNow consents to PeerStream’s reasonable or required disclosure of information regarding this Agreement, as soon as practicable after Proof of Concept is establishedthe relationship contemplated hereunder, cooperate to transfer and provide copies of (the Platform in any filings or submissions to the extent SEC, including periodic and other reports required to be filed by PeerStream with the SEC. 7.4.3 Any alterations that they are YouNow makes to the structuring of the integration of the PeerStream Apps that YouNow deems necessary in order to address regulatory considerations that would restrict the integration of the PeerStream Apps and performance of this Agreement from being consummated, or that would cause performance to be unduly expensive in light of costs and regulatory burdens on YouNow or the Platform, shall be deemed to constitute good faith performance under this Agreement. 7.4.4 While PeerStream may become eligible to receive Props Tokens from the Protocol Rewards Engine in the future, PeerStream acknowledges that this Agreement does not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead contemplate any payments to obtain Regulatory Approval for any Licensed ProductPeerStream from the Protocol Rewards Engine. Further, Gilead shall keep Achillion reasonably apprised PeerStream and YouNow acknowledge and agree that: (i) No money or other consideration is being solicited in connection with any YouNow offering from the Protocol Rewards Engine, and if sent in response, will not be accepted; (ii) No offer to buy Props Tokens can be accepted and no part of any purchase price can be received in connection with any YouNow offering from the progress of all Drug Approval Applications through the progress reports presented Protocol Rewards Engine until an offering statement is qualified pursuant to the Development CommitteeSecurities Act of 1933, and will provide Achillion copies as amended (the “Securities Act”); (iii) Any such offer may be withdrawn or revoked, without obligation or commitment of all reasonably requested regulatory filings within a reasonable any kind, at any time before notice of its acceptance given after their submission to the relevant Regulatory Authority.qualification date; and

Regulatory. (a) Filings. Between 5.1 Regulatory Matters with Respect to Licensed Compounds and Licensed Products in the Effective Date Co-Promotion Territory. 5.1.1 Subject to the terms and conditions of this Agreement, until such time as responsibility for regulatory matters in the date Proof of Concept is establishedCo-Promotion Territory for Licensed Compounds and Licensed Products are transferred to Bayer pursuant to Sections 5.1.2 and 5.3, Achillion in the Co-Promotion Territory, Loxo shall be responsible for: (i) determining, planning and implementing the regulatory plans and strategies for Licensed Compounds and shall file Licensed Products in the Co-Promotion Territory; (ii) either directly or through its Affiliates, making all regulatory filings with respect to Licensed Compounds and own Licensed Products in the Co-Promotion Territory including NDA/▇▇▇▇; (iii) holding all Drug Approval Applications. Upon establishment IND/CTAs and Marketing Authorizations for Licensed Compounds and Licensed Products throughout the Co-Promotion Territory in the name of Proof either itself or its Affiliates until the transfer of Conceptsuch IND/CTAs and Marketing Authorizations as contemplated by Section 5.1.2; and (iv) subject to Sections 5.6 and 5.7, Gilead shall become responsible for, and Achillion will transfer to Gilead, handling all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications interactions with Regulatory Authorities in relation thereto (the Co-Promotion Territory with respect to Licensed Compounds and Licensed Products, including all submissions, meetings and discussions in all cases. 5.1.2 As soon as practical after receipt of the Marketing Authorization for the Co-Promotion Territory, on a Licensed Product-by-Licensed Product basis but no later than, in the case of a LOXO-101 Product, [***], and in the case of a LOXO-195 Product, [***] for such LOXO-195 Product for the Co-Promotion Territory, Loxo shall do all things reasonably necessary or useful to transfer, and Bayer shall provide Loxo reasonable assistance in connection thereto, as well as do all things reasonably necessary or useful to assume and take over, any Regulatory Documentation, including, to the extent permitted by law). (i) Prior Law, all IND/CTAs and Marketing Authorizations related to establishment the applicable Licensed Product Controlled by Loxo or any of Proof its Affiliates for the Co-Promotion Territory into the name of ConceptBayer or its designated Affiliate. Loxo shall, Gilead and Achillion will collaborate shall cause its Affiliates to, duly execute and deliver, or cause to facilitate regulatory activitiesbe duly executed and delivered such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments as Bayer may reasonably request from time to time in connection with Bayer’s rights under this Section 5.1.2. In furtherance [***] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of that goalthe Securities Act of 1933, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authoritiesas amended. Gilead shall have the right to review, comment upon and participate in any decision made Confidential treatment has been requested with respect to a Drug Approval Application, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requestsinformation. (ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authority.