Common use of Regulatory Clause in Contracts

Regulatory. (a) Seller has made available to Buyer complete and correct copies of (i) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the 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) made an untrue statement of a material fact or fraudulent statement to 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 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigators.

Regulatory. (a) Seller has made available to Buyer complete To the knowledge of the Company, the Specified Regulatory Filings are current and correct copies of (i) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts include all regulatory filings and governmental registrations made by or issued to the Company that would constitute a material default 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 noncompliance under decisions) in the Product INDCompany’s files relating to the Specified Regulatory Filings. To the knowledge of the Company, in the course of the clinical development of the Specified Technology, the Company has not used any employee, officer, agent or consultant who (at the time such employee or consultant provided services to the Company with respect to the Specified Technology) was disbarred by the FDA or the subject of pending disbarment proceedings by the FDA. (b) With respect to the Purchased Assets, Seller The Company is in substantial compliance with the Act, including the regulations promulgated thereunder, and any state or foreign Laws laws applicable to the development, manufacture, labeling, testing, safety subjecting to clinical evaluation and inspection of 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 efficacy seizures have been ordered or, to the knowledge of pharmaceutical products (“Pharmaceutical Laws”)the Company, except as would not, individually threatened by any governmental body with respect to any of the Specified Products. The Company has not received a warning letter or in other similar written notice from the aggregate, have a Material Adverse EffectFDA regarding the Specified Products or the manufacturing facilities used to manufacture the Specified Products. Seller The Company has not received any written, or, to Seller’s Knowledge, other written notice from that the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law authority has commenced or initiating, or threatening overtly threatened to initiate, 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 enjoin production or clinical investigators acting for Seller have not (i) evaluation of any Specified Products. To the knowledge of the Company, no officer, employee or agent of the Company has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authorityauthority, (ii) or committed an act, made a statement or failed to disclose make a material fact required statement that, at the time such disclosure was made, could reasonably be expected to be disclosed to provide a basis for 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 authority to invoke with respect to the Company its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, Bribery and Illegal Gratuities Final PolicyGratuities”, 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(din 56 Fed. Reg. 46191 (September 10, 1991) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorspolicy.

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) Seller has made available the JSC will discuss in good faith whether to Buyer complete and correct copies of (i) all Product INDs transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (iib) 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 Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by 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 Purchased Recordssuch Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of 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 the 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, exclusive, and 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. All Product INDs 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 full force the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and effect maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and there are no facts that would constitute a material default any pricing or noncompliance under reimbursement approvals, as applicable, for Licensed Products in the Product INDTerritory. (b) With Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review 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 or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority 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) made an untrue statement of a material fact or fraudulent statement to 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 Material Facts, Bribery, and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policyRegulatory Submission. (c) Seller has filed Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the FDA and other applicable Governmental Authorities all required material filingsTerritory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, declarationsprovided, listingshowever, registrationsthat NVCR or its designee shall have the right, 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller norobligation, 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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a material debarment written summary thereof in English promptly following such meeting or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsdiscussion.

Regulatory. (a) Seller has The Borrower Parties have made available to Buyer complete Lender all of the following documents that Borrower and correct copies of its Subsidiaries have received or possess otherwise in any form: (i) all material files relating to Regulatory Approvals, regulatory correspondence, written notes in respect of telephone communications, electronic communications and copies of all material submissions to any active regulatory files regarding preclinical, clinical and manufacturing activities and any material notices and forms received from Regulatory Agencies 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 “[***]”. 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. (ii) all (A) adverse experience reports relating to the 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 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 INDs 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 adulterated or misbranded within the meaning of the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 351, 352, in any 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 material Regulatory Approvals for the Included Products (including the name in which such Regulatory Approval is 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, and applications therefor which Borrower and its Subsidiaries have in connection with the Included Products; and (ii) to the Knowledge of Borrower, constitute all Purchased Recordssuch 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 Product INDs 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 there are no facts that validly issued, in each case except as would constitute not be reasonably expected to result in a material default or noncompliance under the Product INDMaterial Adverse Effect. (bg) With The studies, tests and nonclinical and clinical trials conducted by or on behalf of Borrower and its Subsidiaries with respect to the Purchased AssetsIncluded Products were, Seller is and if still pending are being, conducted in compliance 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 Actresults 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 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 nonclinical and clinical trials conducted by or on behalf of Borrower and its Subsidiaries with respect to 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 the regulations promulgated thereunderwith respect to any Regulatory Approval or Intellectual Property, and any state or foreign Laws applicable to the development, testing, safety or efficacy of pharmaceutical products (“Pharmaceutical Laws”), except as would notwhich would, 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) made an untrue statement of a material fact or fraudulent statement to 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 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsMaterial Adverse Effect.

Regulatory. (a) Seller has 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 available with respect to Buyer complete a Drug Approval Application, and correct 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 (ito the extent that they are not then in Gilead’s possession) all Product INDs Drug Approval Applications, Information, data, protocols, clinical study reports and (ii) 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 Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under Drug Approval Applications through the Product IND. (b) With respect progress reports presented to the Purchased Assets, Seller is in compliance with the Act, including the regulations promulgated thereunderDevelopment Committee, and any state or foreign Laws applicable will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission 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) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental relevant Regulatory 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 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigators.

Regulatory. (a) Seller has made available to Buyer complete and correct copies The Existing Regulatory Filings constitute all of (i) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND. (b) With Regulatory Approvals with respect to the Purchased Assets, Seller is in compliance with Lead Compound and the Act, including the regulations promulgated thereunder, and any state or foreign Laws applicable Additional Compound that have been granted 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 Effectname of any Seller Party or any of their Affiliates on or prior to the Closing Date. No Seller Party or Affiliate of any Seller Party has not received any written, or, to Seller’s Knowledge, other written notice from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiatingBody of, 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 Seller Parties’ Knowledge, there are no circumstances currently existing that would reasonably be expected to lead to, any loss of Selleror refusal to renew any Existing Regulatory Filings or result in an investigation, Seller’s officers, employees, agents corrective action or clinical investigators acting for Seller have not (i) made an untrue statement of a material fact or fraudulent statement to enforcement action by the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed Body with respect to the FDA or any other Governmental Authority or (iii) committed any other act, made any statement or failed 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 make any statement, that establishes a reasonable basis the Lead Compound and the Additional Compound and the Transferred Assets during the conduct of the development program for the FDA Lead Compound and the Additional Compound undertaken by Seller Parties and their Affiliates prior to invoke its Fraudthe Closing Date, Untrue Statements of Material Factsincluding the FD&C Act, Briberythe Public Health Service Act, the Prescription Drug Marketing Act and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policy. (c) Seller has filed with regulations issued by the FDA thereunder and other 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 Authorities Authorizations. Seller Parties have provided to Buyer in the Data Room with true, accurate and complete information, reports and data concerning all required material filingsscientific studies relating to the Lead Compound and the Additional Compound conducted by Seller Parties and their Affiliates. To the Knowledge of Seller Parties, declarations, listings, registrations, reports, applications or submissions, including but not limited Seller Parties have provided to Product INDs and adverse event reports, required by Pharmaceutical Laws Buyer 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 Data Room all pre-clinical studies and clinical investigations trial information involving the Lead Compound and the Additional Compound conducted or trials sponsored generated by or conducted 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 Closing Date may be provided by means other than the Data Room). Except as has been disclosed in connection writing to Buyer, to the Knowledge of Seller Parties no CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, 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 Purchased Assets 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 the Additional Compound have been and are being conducted in all material respects in compliance with applicable Pharmaceutical Lawsthe requirements of good clinical practice, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence from informed consent, institutional review boards (as those terms are defined by the FDA or any other Governmental Authority commencingrelevant Regulatory Authorities), or threatening to initiate, 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 and other applicable Law relating to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Productprotection of human subjects, other than in each case as set forth on Section 3.7(d) of applicable and that were in effect at the Seller Disclosure Schedule (time such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Producttests were conducted. (eb) Neither Seller nor, to the Knowledge Party nor any of Seller, any officer, employeetheir Affiliates has been subject to, or agent of Seller has been convicted of any crime or engaged in any conduct in connection with respect to the Purchased Assets Lead Compound and the Additional Compound that has resulted in or could would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Pharmaceutical Law Law, or (ii) exclusion from participating in the federal health care programs under 42 U.S.C. Section 1320a-7 1128 of the Social Security Act or any similar Pharmaceutical Law. There are no claims. (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, actionsprocessing and disclosure of information or data; (ii) written claim for compensation for loss or unauthorized collection, proceedings processing or investigations 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 Purchased Assets that could reasonably be expected to result Lead Compound or the Additional Compound. (d) Seller Parties have 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, in all material respects, at the time such a material debarment or exclusion that are pending ordata, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsdocuments and reports were documented and stored.

Regulatory. (a) Seller has made available 7.4.1 PeerStream acknowledges and agrees that YouNow’s performance of its obligations under this Agreement may be subject to Buyer complete and correct copies contingent on the resolution of any regulatory considerations relating to such obligations. 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 to the extent such failure or delay is caused by 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) all Product INDs Peerstream consents to YouNow’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Peerstream Apps in any filings or submissions to the U.S. Securities and Exchange Commission (“SEC”), including any such YOUNOW MASTER SERVICES AGREEMENT 7 CONFIDENTIAL filings or submissions relating to an offering pursuant to Regulation A of the Securities Act of 1933, as amended (“Regulation A”), or periodic and other reports required to be filed by YouNow with the SEC and (ii) all Purchased Records. All Product INDs are YouNow consents to PeerStream’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Platform in full force any filings or submissions to the SEC, including periodic and effect and there are no facts other reports required to be filed by PeerStream with the SEC. 7.4.3 Any alterations that 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 a material default or noncompliance good faith performance under the Product INDthis Agreement. (b) With respect 7.4.4 While PeerStream may become eligible to receive Props Tokens from 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 Protocol Rewards Engine in the aggregatefuture, have a Material Adverse Effect. Seller has PeerStream acknowledges that this Agreement does not received contemplate any written, or, payments to Seller’s Knowledge, other notice PeerStream from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiatingProtocol Rewards Engine. Further, 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 PeerStream and YouNow acknowledge and agree that: (i) made an untrue statement of a material fact No money or fraudulent statement to other consideration is being solicited in connection with any YouNow offering from the FDA or any other Governmental AuthorityProtocol Rewards Engine, and if sent in response, will not be accepted; (ii) failed No offer to disclose a material fact required to buy Props Tokens can be disclosed accepted and no part of any purchase price can be received in connection with any YouNow offering from the Protocol Rewards Engine until an offering statement is qualified pursuant to the FDA or any other Governmental Authority or Securities Act of 1933, as amended (the “Securities Act”); (iii) committed any other actAny such offer may be withdrawn or revoked, made any statement without obligation or failed to make any statement, that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller nor, to the Knowledge of Seller, any officer, employee, or agent of Seller has been convicted commitment of any crime or engaged in kind, at 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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any time before notice of its respective officers, employees, agents or clinical investigators.acceptance given after the qualification date; and

Regulatory. (a) Seller has made available Licensee shall be responsible for all regulatory activities related to Buyer complete the development and correct copies commercialization of (i) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product INDin the Field in the Territory, at Licensee’s own cost and expense. Licensee shall prepare and file all Regulatory Materials necessary to obtain and maintain the Regulatory Approval of the Product in the Field in the Territory and shall be responsible for all communication and interaction with Regulatory Authorities with respect thereto. (b) With respect to the Purchased AssetsAt Licensee’s request and expense, Seller is Licensor shall provide Licensee with reasonable assistance 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 Assetsregulatory activities for the Product in the Field in the Territory. Licensor shall provide Licensee access to all material preclinical and clinical data, Seller has not andresults, 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 Knowledge of Seller, Seller’s officers, employees, agents or clinical investigators acting Licensed Virus in the Field (the “Licensor Data”) for Seller have not (i) made an untrue statement of a material fact or fraudulent statement to 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 use by Licensee in obtaining Regulatory Approval for the FDA to invoke its Fraud, Untrue Statements of Material Facts, BriberyProduct in the Field in the Territory, and Illegal Gratuities Final PolicyLicensee shall have a right of access, or a right of reference and a right to use and incorporate all such Licensor Data for any other Governmental Authority to invoke such a policypurposes of obtaining Regulatory Approval of the Product in the Field in the Territory. (c) Seller has filed Licensee shall provide Licensor with drafts of all Regulatory Materials relating to the FDA 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 allowed by applicable laws and regulations. In addition, Licensee shall provide Licensor with copies of any Regulatory Materials relating to the Product submitted to or received from any Regulatory Authority in the Territory within ten (10) days after submission or receipt, and shall notify Licensor of any other applicable Governmental Authorities all required material filings, declarations, listings, registrations, reports, applications or submissions, including but not limited communication relating to the Product INDs and adverse event reports, required by Pharmaceutical Laws with any Regulatory Authority in connection with the Purchased Assets. All Territory within ten (10) days after 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 effectcommunication. (d) All preclinical If any Regulatory Exclusivity is available for any Product in any country or jurisdiction, Licensee shall, at its own cost and clinical investigations expense, use Commercially Reasonable Efforts to seek and maintain such Regulatory Exclusivity protection for such Product. If Licensee does not seek or trials sponsored by or conducted on behalf of Seller in connection with maintain such Regulatory Exclusivity protection, then Licensor shall have the Purchased Assets have been right (but not the obligation) to do so at Licensor’s own cost and are being conducted in material compliance with applicable Pharmaceutical Lawsexpense; provided that if Licensor successfully obtains such Regulatory Exclusivity protection, including Good Clinical Practices requirements thereunder Licensee shall reimburse Licensor for all cost and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Productexpense incurred. (e) Neither Seller nor, Licensee shall keep Licensor informed with respect to any adverse event or safety issues relating to the Knowledge development or commercialization of Sellerthe 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 officerrecall, employeecorrective 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, or agent including the decision to commence such Remedial Action, and shall bear all cost and expense thereof. Licensee shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit Licensee to trace the distribution, sale and use of Seller has been convicted of any crime or engaged the Product in any conduct the Field 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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsTerritory.

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”) Seller which have been provided to Broadridge and the 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 made available been provided in writing to Buyer 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 correct copies understands that E*TRADE (any of its parent, subsidiaries and Affiliates) is subject to examination and oversight by various federal and state regulators and governmental administrative agencies, including, without limitation, the Office of the Comptroller of the Currency, and that by entering into this Schedule with E*TRADE, Broadridge may be subject to examination and oversight by such regulators and agencies. Broadridge hereby agrees, but solely to the extent that such examination relates to the Services provided by Broadridge to E*TRADE hereunder, to submit to and reasonably cooperate in any such examination, at E*TRADE’s expense, and 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) all Product INDs overviews of its disaster recovery and business continuity plans; (ii) all Purchased Recordsdisaster *** Confidential treatment has been requested for the redacted portions. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND. (b) With respect to the Purchased Assets, Seller is in compliance The Confidential Information redacted has been filed separately with the Act, including the regulations promulgated thereunder, Securities 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 EffectExchange Commission. 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) made an untrue statement of a material fact or fraudulent statement to 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 recovery test results; (iii) committed any other actan overview of Broadridge’s information security program, made any statement or failed to make any statement(iv) books and records; and (v) facilities, that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Briberysystems, and Illegal Gratuities Final Policy, or for any other Governmental Authority equipment on supervised visits and without actual access to invoke such a policyBroadridge’s systems. (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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigators.

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) Seller has made available to Buyer complete Osiris will be the sponsor of pre-clinical and correct copies clinical trials of (i) all a Product INDs for an Indication in the Osiris Territory and (ii) all Purchased Records. All Product INDs are in full force shall be responsible for holding and effect and there are no facts that would constitute a material default or noncompliance under managing the Product IND., but shall reasonably consult with Genzyme on strategic planning matters related thereto; (b) With respect to Genzyme will be Osiris’s legal representative within the Purchased Assets, Seller is in compliance with the Act, including the regulations promulgated thereunder, meaning of Directive 2001/20/EC of pre-clinical and any state or foreign Laws applicable to the development, testing, safety or efficacy clinical trials of pharmaceutical products (“Pharmaceutical Laws”), except as would not, individually or a Product for an Indication in the aggregateGenzyme Territory and shall be responsible for holding and managing all regulatory filings, 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 but shall reasonably consult 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) made an untrue statement of a material fact or fraudulent statement to 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 Material Facts, Bribery, and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policy.Osiris on strategic planning matters related thereto; (c) Seller has filed Osiris will be responsible for filing the BLA and CTD supporting marketing authorization for a Product for an Indication with the FDA and other applicable Governmental Authorities all required material filings, declarations, listings, registrations, reports, applications or submissions, including appropriate Regulatory Agencies in the Osiris Territory; but not limited shall reasonably consult with Genzyme on strategic planning matters related to Product INDs and adverse event reports, required by Pharmaceutical Laws in connection with the Purchased Assets. All such filings. Osiris shall have the right to use all data related to a Product for an Indication, declarations, listings, registrations, reports, applications or to reference the CTD and to incorporate by reference any and all parts of regulatory submissions were in material compliance with applicable Pharmaceutical Laws when filed and remain in full force and effect.made by Genzyme for any Indication; (d) All preclinical Genzyme will be responsible for filing the BLA and clinical investigations or trials sponsored by or conducted on behalf of Seller in connection CTD supporting marketing authorization for a Product for an Indication with the Purchased Assets have been and are being conducted appropriate Regulatory Agencies in material compliance the Genzyme Territory, but shall reasonably consult with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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 Osiris on behalf of Seller relating to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments strategic planning matters related to such filings. Genzyme shall have the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect right to the Ongoing Clinical Trials, Seller has completed and closed out use all other Gilead-sponsored clinical trials data related to a Product for an Indication, to reference the Product.CTD and to incorporate by reference any and all parts of regulatory submissions made by Osiris for any Indication; (e) Neither Seller norThe Parties shall be jointly involved in the strategic planning and in the review of all written and meeting related regulatory communications concerning the Products. For clarity, to the Knowledge this shall not include review of SellerSAE reporting, 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. which is governed by Section 335a or any similar Pharmaceutical Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigators4.

Regulatory. (a) Seller has made available to Buyer complete and correct copies The Existing Regulatory Filings constitute all of (i) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND. (b) With Regulatory Approvals with respect to the Purchased Assets, Seller is in compliance with Lead Compound and the Act, including the regulations promulgated thereunder, and any state or foreign Laws applicable Additional Compound that have been granted 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 Effectname of any Seller Party or any of their Affiliates on or prior to the Closing Date. No Seller Party or Affiliate of any Seller Party has not received any written, or, to Seller’s Knowledge, other written notice from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiatingBody of, 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 Seller Parties’ Knowledge, there are no circumstances currently existing that would reasonably be expected to lead to, any loss of Selleror refusal to renew any Existing Regulatory Filings or result in an investigation, Seller’s officers, employees, agents corrective action or clinical investigators acting for Seller have not (i) made an untrue statement of a material fact or fraudulent statement to enforcement action by the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed Body with respect to the FDA or any other Governmental Authority or (iii) committed any other act, made any statement or failed 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 make any statement, that establishes a reasonable basis the Lead Compound and the Additional Compound and the Transferred Assets during the conduct of the development program for the FDA Lead Compound and the Additional Compound undertaken by Seller Parties and their Affiliates prior to invoke its Fraudthe Closing Date, Untrue Statements of Material Factsincluding the FD&C Act, Briberythe Public Health Service Act, the Prescription Drug Marketing Act and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policy. (c) Seller has filed with regulations issued by the FDA thereunder and other 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 Authorities Authorizations. Seller Parties have provided to Buyer in the Data Room with true, accurate and complete information, reports and data concerning all required material filingsscientific studies relating to the Lead Compound and the Additional Compound conducted by Seller Parties and their Affiliates. To the Knowledge of Seller Parties, declarations, listings, registrations, reports, applications or submissions, including but not limited Seller Parties have provided to Product INDs and adverse event reports, required by Pharmaceutical Laws Buyer 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 Data Room all pre-clinical studies and clinical investigations trial information involving the Lead Compound and the Additional Compound conducted or trials sponsored generated by or conducted 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 Closing Date may be provided by means other than the Data Room). Except as has been disclosed in connection writing to Buyer, to the Knowledge of Seller Parties no [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, 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 Purchased Assets 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 the Additional Compound have been and are being conducted in all material respects in compliance with applicable Pharmaceutical Lawsthe requirements of good clinical practice, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence from informed consent, institutional review boards (as those terms are defined by the FDA or any other Governmental Authority commencingrelevant Regulatory Authorities), or threatening to initiate, 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 and other applicable Law relating to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Productprotection of human subjects, other than in each case as set forth on Section 3.7(d) of applicable and that were in effect at the Seller Disclosure Schedule (time such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Producttests were conducted. (eb) Neither Seller nor, to the Knowledge Party nor any of Seller, any officer, employeetheir Affiliates has been subject to, or agent of Seller has been convicted of any crime or engaged in any conduct in connection with respect to the Purchased Assets Lead Compound and the Additional Compound that has resulted in or could would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Pharmaceutical Law Law, or (ii) exclusion from participating in the federal health care programs under 42 U.S.C. Section 1320a-7 1128 of the Social Security Act or any similar Pharmaceutical Law. There are no claims. (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, actionsprocessing and disclosure of information or data; (ii) written claim for compensation for loss or unauthorized collection, proceedings processing or investigations 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 Purchased Assets that could reasonably be expected to result Lead Compound or the Additional Compound. (d) Seller Parties have 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, in all material respects, at the time such a material debarment or exclusion that are pending ordata, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsdocuments and reports were documented and stored.

Regulatory. (a) Seller has made available to Buyer complete and correct copies The Existing Regulatory Filings constitute all of (i) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND. (b) With Regulatory Approvals with respect to the Purchased Assets, Seller is in compliance with Lead Compound and the Act, including the regulations promulgated thereunder, and any state or foreign Laws applicable Additional Compound that have been granted 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 Effectname of any Seller Party or any of their Affiliates on or prior to the Closing Date. No Seller Party or Affiliate of any Seller Party has not received any written, or, to Seller’s Knowledge, other written notice from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiatingBody of, 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 Seller Parties’ Knowledge, there are no circumstances currently existing that would reasonably be expected to lead to, any loss of Selleror refusal to renew any Existing Regulatory Filings or result in an investigation, Seller’s officers, employees, agents corrective action or clinical investigators acting for Seller have not (i) made an untrue statement of a material fact or fraudulent statement to enforcement action by the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed Body with respect to the FDA or any other Governmental Authority or (iii) committed any other act, made any statement or failed 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 make any statement, that establishes a reasonable basis the Lead Compound and the Additional Compound and the Transferred Assets during the conduct of the development program for the FDA Lead Compound and the Additional Compound undertaken by Seller Parties and their Affiliates prior to invoke its Fraudthe Closing Date, Untrue Statements of Material Factsincluding the FD&C Act, Briberythe Public Health Service Act, the Prescription Drug Marketing Act and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policy. (c) Seller has filed with regulations issued by the FDA thereunder and other 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 Authorities Authorizations. Seller Parties have provided to Buyer in the Data Room with true, accurate and complete information, reports and data concerning all required material filingsscientific studies relating to the Lead Compound and the Additional Compound conducted by Seller Parties and their Affiliates. To the Knowledge of Seller Parties, declarations, listings, registrations, reports, applications or submissions, including but not limited Seller Parties have provided to Product INDs and adverse event reports, required by Pharmaceutical Laws Buyer 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 Data Room all pre-clinical studies and clinical investigations trial information involving the Lead Compound and the Additional Compound conducted or trials sponsored generated by or conducted 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 Closing Date may be provided by means other than the Data Room). Except as has been disclosed in connection writing to Buyer, to the Knowledge of Seller Parties no Tarpon – Asset Purchase Agreement Strictly Confidential CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, 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 Purchased Assets 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 the Additional Compound have been and are being conducted in all material respects in compliance with applicable Pharmaceutical Lawsthe requirements of good clinical practice, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence from informed consent, institutional review boards (as those terms are defined by the FDA or any other Governmental Authority commencingrelevant Regulatory Authorities), or threatening to initiate, 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 and other applicable Law relating to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Productprotection of human subjects, other than in each case as set forth on Section 3.7(d) of applicable and that were in effect at the Seller Disclosure Schedule (time such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Producttests were conducted. (eb) Neither Seller nor, to the Knowledge Party nor any of Seller, any officer, employeetheir Affiliates has been subject to, or agent of Seller has been convicted of any crime or engaged in any conduct in connection with respect to the Purchased Assets Lead Compound and the Additional Compound that has resulted in or could would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Pharmaceutical Law Law, or (ii) exclusion from participating in the federal health care programs under 42 U.S.C. Section 1320a-7 1128 of the Social Security Act or any similar Pharmaceutical Law. There are no claims. (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, actionsprocessing and disclosure of information or data; (ii) written claim for compensation for loss or unauthorized collection, proceedings processing or investigations 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 Purchased Assets that could reasonably be expected to result Lead Compound or the Additional Compound. (d) Seller Parties have 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, in all material respects, at the time such a material debarment or exclusion that are pending ordata, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsdocuments and reports were documented and stored.

Regulatory. (a) Seller has made available to Buyer complete and correct copies Regulatory Responsibilities of (i) all Product INDs and (ii) all Purchased RecordsClearside. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND. (b) With respect Prior to the Purchased AssetsXIPERE NDA Approval Date, Seller is Clearside shall be solely responsible for all regulatory activities and all interactions with Regulatory Authorities necessary to obtain Regulatory Approval of the XIPERE Product in compliance with the ActUnited States and shall bear all costs and expenses relating thereto, 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) made an untrue statement of a material fact or fraudulent statement to 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 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 items set out in material compliance with applicable Pharmaceutical Laws when filed and remain in full force and effect. Exhibit 5.1 (d) All preclinical and clinical investigations or trials sponsored by or conducted on behalf of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical TrialsAdditional Clearside Regulatory Matters”). Except 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 communications which Clearside receives from the applicable Regulatory Authority concerning the XIPERE Product, (b) provide Bausch Health with draft copies of all proposed communications from Clearside to the applicable Regulatory Authority with respect to the Ongoing Clinical TrialsXIPERE Product (including any Additional Clearside Regulatory Matters ) prior to Clearside’s submission thereof, Seller has completed and closed out all other Gilead-sponsored clinical trials related (c) permit Bausch Health with a reasonable period of time 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 Product. Regulatory Authority without the prior consent of Bausch Health, such consent not to be unreasonably withheld (efor 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 [***]) Neither Seller nor, inform Bausch Health of any material regulatory developments with respect to the Knowledge XIPERE Product in the Territory that may negatively affect the timeline for the First Commercial Sale of Sellerthe XIPERE Product in the Territory and shall promptly respond to Bausch Health’s reasonable questions or requests for information relating thereto. In addition, any officerwithin [***] following the end of each calendar quarter until the XIPERE NDA Approval Date, employee, or agent Clearside shall provide a written report to Bausch Health setting forth in reasonable detail the status of Seller has been convicted of any crime or engaged its then-current regulatory activities 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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, relation to the Knowledge of Seller, threatened against Seller XIPERE Product in the Territory. Clearside shall promptly respond to Bausch Health’s reasonable questions or requests for information relating to any of its respective officers, employees, agents or clinical investigatorssuch written report.

Regulatory. On a Licensed Compound-by-Licensed Compound basis, with respect to any Licensed Product that contains a Licensed Compound, from and after the Effective Date until and unless such Licensed Compound is a Terminated Compound, as between the Parties and subject to the terms of this Agreement, Inmagene will have the right, itself or with or through its Affiliates, Sublicensees or other Third Parties, to: (a) Seller has made available prepare and submit to Buyer complete and correct copies of (i) applicable Regulatory Authorities all Product INDs and (ii) all Purchased Records. All Product INDs are Regulatory Materials, including INDs, for such Licensed Products in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND. Field, (b) With obtain and maintain all Regulatory Approvals for such Licensed Products in the Field, and (c) conduct communications with the Regulatory Authorities for such Licensed Products in the Field. During the Option Term with respect to a Licensed Compound, Inmagene may request Hutchison assist, [***], in Inmagene’s efforts to prepare and submit any Regulatory Filings to obtain, support, or maintain Regulatory Approvals for any Licensed Product containing such Licensed Compound. For all Licensed Products, Inmagene will keep Hutchison reasonably informed regarding the Purchased Assets, Seller is in compliance with the Actstatus and progress of such regulatory activities, including by (a) during the regulations promulgated thereunderOption Term for a Licensed Compound, providing Hutchison with a copy of any written correspondence from a Regulatory Authority involving Regulatory Filings for any such Licensed Product containing such Licensed Compound; (b) notifying Hutchison of any major topic made by oral correspondence from a Regulatory Authority involving Regulatory Filings; (c) providing Hutchison with a copy of each Regulatory Filing (i.e., IND, orphan drug applications and designations, and any state or their foreign Laws applicable counterparts) 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) made an untrue statement of a material fact or fraudulent statement be submitted to the FDA or a Regulatory Authority in any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed country in advance of submission 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 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. relevant Regulatory Authority; (d) All preclinical and clinical investigations or trials sponsored by or conducted on behalf providing Hutchison with a copy of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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 all final Regulatory Filings promptly after submission to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed relevant Regulatory Authority; and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller norpromptly informing Hutchison regarding the receipt or denial of Regulatory Approval for such Licensed Product obtained or denied; provided, however, that in all circumstances, to the Knowledge extent permitted under Applicable Law, Inmagene will inform Hutchison of Seller, any officer, employee, or agent such event prior to public disclosure 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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsevent by Inmagene.

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) Seller has made available the JSC will discuss in good faith whether to Buyer complete and correct copies of (i) all Product INDs transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (iib) 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 Zai 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, in each case ((a) or (b)), to the extent permitted by 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 Purchased Recordssuch Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of 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 the 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, exclusive, and 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. All Product INDs 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 full force the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and effect maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and there are no facts that would constitute a material default any pricing or noncompliance under reimbursement approvals, as applicable, for Licensed Products in the Product INDTerritory. (b) With Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review 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 or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority 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) made an untrue statement of a material fact or fraudulent statement to 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 Material Facts, Bribery, and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policyRegulatory Submission. (c) Seller has filed Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the FDA and other applicable Governmental Authorities all required material filingsTerritory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, declarationsprovided, listingshowever, registrationsthat NVCR or its designee shall have the right, 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller norobligation, 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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a material debarment written summary thereof in English promptly following such meeting or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigators.discussion. 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. 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) Seller has made available the JSC will discuss in good faith whether to Buyer complete and correct copies of (i) all Product INDs transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (iib) 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 Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 21 Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by 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 Purchased Recordssuch Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of 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 the 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, exclusive, and 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. All Product INDs 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 full force the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and effect maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and there are no facts that would constitute a material default any pricing or noncompliance under reimbursement approvals, as applicable, for Licensed Products in the Product INDTerritory. (b) With Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review 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 or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority 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) made an untrue statement of a material fact or fraudulent statement to 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 Material Facts, Bribery, and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policyRegulatory Submission. (c) Seller has filed Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the FDA and other applicable Governmental Authorities all required material filingsTerritory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, declarationsprovided, listingshowever, registrationsthat NVCR or its designee shall have the right, 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller norobligation, 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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a material debarment written summary thereof in English promptly following such meeting or exclusion that are pending ordiscussion. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, to the Knowledge of SellerMARKED WITH [***], threatened against Seller or any of its respective officers, employees, agents or clinical investigators.HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 22

Regulatory. (a) Seller The Company has made available to Buyer complete been and correct copies of (i) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND. (b) With respect to the Purchased Assets, Seller is in compliance in all material respects with applicable Health Care Laws. The Company has filed with the Act, applicable Governmental Entities (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 Entity performing functions similar to those performed by the FDA) all required filings, representations, declarations, listings, registrations, reports or submissions. To the Company’s Knowledge, all such filings, representations, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Health Care Laws when filed, and no material deficiency has been asserted by any Pharmaceutical Law applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or initiatingsubmissions. 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 threatening to initiatethe Company’s Knowledge, oral, notice or other material correspondence from any action Governmental Entity, including the FDA or any other Governmental Entity, with respect to suspend or terminate a Product INDany Company Product. In connection with the Purchased Assets, Seller has not andThere is no pending or, to the Knowledge Company’s Knowledge, threatened action, suit, claim, order, injunction, investigation or proceeding of Sellerany nature pending or threatened, Selleror 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 officersKnowledge, employees, agents or clinical investigators acting for Seller have the Company has not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental AuthorityEntity responsible for enforcement or oversight with respect to Health Care Laws, (ii) or failed to disclose a material fact required to be disclosed to the FDA or any other such Governmental Authority Entity. All applications, notifications, submissions, information, claims, reports and statistics and other data that have been utilized, or (iii) committed any other actprepared with the intention to be utilized, made any statement or failed to make any statement, that establishes a reasonable as the basis for the FDA to invoke its Fraud, Untrue Statements of 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 submitted in connection with the Purchased Assets. All such filings, declarations, listings, registrations, reports, applications any regulatory 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 marketing approvals or trials sponsored by or conducted on behalf of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence Permits from the FDA or any other Governmental Authority commencing, or threatening to initiate, 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 Entity relating to the Purchased Assets. As Company Products were true, correct and complete in all material respects as of the date of this Agreementpreparation and submission, there are no ongoing clinical trials as applicable, and any necessary or clinical trial commitments 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 ProductCompany Products, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller nor, to the Knowledge of Seller, any officer, employee, or agent of Seller has been convicted of any crime or is or has been debarred, excluded or disqualified under applicable Health Care Laws, including 21 U.S.C. Section 335a, or, to the Company’s Knowledge has engaged in any conduct in connection with the Purchased Assets that has resulted resulted, or would reasonably be expected to result, in such criminal conviction or could debarment, exclusion or disqualification. To the Company’s Knowledge, no action that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a any such criminal conviction, debarment, exclusion or disqualification are pending or threatened against the Company or any similar Pharmaceutical Law or (iiPerson(s) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are engaged by the Company who have performed work related to the Company Products, and, to the Company’s Knowledge and the Company, there is no claims, actions, proceedings or investigations in connection with the Purchased Assets fact that could reasonably be expected give rise to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsan 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) Seller has made available submission for medical clearance for the Integrated StatView Product portion of their integrated monitoring device, including aid in providing product-testing data. Notwithstanding the 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 related hardware (including the receivers and transmitters). Data Critical agrees to Buyer complete and correct copies aid Agilent in the event of a FDA (ior equivalent foreign medical regulatory agency) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default recall or noncompliance under the Product IND. (b) With respect other product failure issues relating to the Purchased AssetsIntegrated StatView Product or Data Critical's proprietary receivers. In addition Data Critical will aid Agilent, Seller is in compliance as reasonably requested, with the Act, including the regulations promulgated thereunder, post market surveillance information and any state or foreign Laws applicable related Medical Device Records relating 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 EffectIntegrated StatView Product and/or such receivers. Seller has not received any written, or, to Seller’s Knowledge, other notice from the FDA or any other Governmental Authority alleging noncompliance Agilent will provide Data Critical with any Pharmaceutical Law FDA (or initiating, equivalent foreign medical regulatory agency) or threatening to initiate, any action to suspend or terminate a Product IND. In connection with the Purchased Assets, Seller has not and, customer failure/safety information relating to the Knowledge of Seller, Seller’s officers, employees, agents Integrated StatView Product or clinical investigators acting for Seller have not (i) made an untrue statement of the receivers used in connection therewith on a material fact or fraudulent statement timely basis. Notwithstanding anything contained herein to the FDA contrary, Agilent shall provide and make available all information obtained 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 Material Facts, Bribery, and Illegal Gratuities Final Policy, prepared by 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 Agilent in connection with Agilent's application for medical regulatory clearance of the Purchased Assets. All Integrated StatView Product abroad, and Data Critical shall have the right to use such filingsinformation for the purpose of seeking FDA, declarationsFCC (or similar foreign) regulatory clearance in such countries of its products; provided that -------- to the extent any such information consists of specific patient information, listingssuch information shall be provided by Agilent only to the extent, registrationsand in such form, reportsas shall in either case, applications or submissions were in material compliance with be permitted pursuant to any applicable Pharmaceutical Laws when filed and remain in full force and effectlaw. (d) All preclinical and clinical investigations or trials sponsored by or conducted on behalf of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws11.2. Data Critical will immediately give notice to Agilent if any upgrade, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice substitution or other correspondence from change to an Integrated StatView Product or the FDA related transmitters or any receivers is required to make that product meet applicable safety standards or other Governmental Authority commencinggovernmental statutes, rules, orders or threatening to initiate, 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. As regulations that are in effect as of the date of this Agreementagreement in the United States. All affected Integrated StatView Products, there are no ongoing clinical trials transmitters or clinical trial commitments related 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 Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Productfield. (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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigators.

Regulatory. Until the Closing, without limiting Sections 7.11 to 7.13: (a) Seller has made available Equillium shall be responsible for the preparation of all Regulatory Materials necessary or desirable for the performance of the Program, including to Buyer complete the extent contemplated by the Development Plan, and correct copies of (i) 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 Product INDs Regulatory Materials shall be held and (ii) all Purchased Recordsowned by Equillium in its name. All Product INDs are in full force Equillium shall keep ▇▇▇ reasonably informed regarding meetings and effect and there are no facts that would constitute a material default or noncompliance under the Product INDcommunications with Regulatory Authorities regarding any Product. (b) With respect to the Purchased Assets, Seller is in compliance with the Act, including the regulations promulgated thereunderEquillium shall, and any state or foreign Laws applicable to the developmentshall cause each of its Subsidiaries to, 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 initiatingmaintain, or threatening cause to initiatebe maintained, any action to suspend or terminate current and accurate records of all Regulatory Materials and regulatory data that such parties may acquire for a Product INDperiod covering, at a minimum, the Record Retention Period. In addition, Equillium shall keep Ono reasonably and regularly informed in connection with the Purchased Assetspreparation of all Regulatory Materials, Seller has not and, to the Knowledge Regulatory Authority review of Seller, Seller’s officers, employees, agents or clinical investigators acting for Seller have not (i) made an untrue statement of a material fact or fraudulent statement to 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 Material Facts, BriberyRegulatory Materials, and Illegal Gratuities Final PolicyRegulatory Approvals, or for in each case with respect to any other Governmental Authority to invoke such a policyProduct. (c) Seller has filed Equillium shall be responsible for complying with the FDA and other pharmacovigilance obligations under 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 Program and remain in full force and effecteach Product. (d) All preclinical and clinical investigations Equillium shall promptly inform ▇▇▇ of notification of any action by, or trials sponsored by or conducted on behalf of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice notification or other correspondence from the FDA information which it receives (directly or any other Governmental Authority commencing, or threatening to initiateindirectly) from, any action to place a clinical hold order on, Regulatory Authority which (i) raises any material concerns regarding the safety or to terminate, delay, suspend, or materially modify efficacy of any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of Seller relating to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d(ii) of the Seller Disclosure Schedule (such clinical trialsis reasonably likely to lead to a recall, the “Ongoing Clinical Trials”). Except market withdrawal or market notification with respect to the Ongoing Clinical Trials, Seller has completed any Product or (iii) relates to expedited and closed out all other Gilead-sponsored clinical trials related periodic reports of adverse events with respect to the Productany Product which may have an adverse impact on any Regulatory Approval. (e) Neither Seller norIf 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, or that the suspension or termination of any such clinical trial, or a deviation from or amendment to the Knowledge protocol of Sellerany such clinical trial, is in the best interest of patients / subjects, or if any Regulatory Authority imposes a hold on, or requires or recommends the suspension or termination of, any officersuch clinical trial, employeethen, in each case, Equillium shall promptly inform ▇▇▇ thereof. Notwithstanding anything in this Agreement to the contrary, with respect to any of the 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 a clinical trial or deviation from, or agent of Seller has been convicted of any crime amendment to, the protocol for a clinical trial) as it determines in good faith are necessary, appropriate or engaged in any conduct in connection advisable and consistent with the Purchased Assets that has resulted in best interest of patients / subjects or could reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Pharmaceutical Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical required by applicable Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsincluding GCP.

Regulatory. (a) Seller has made available to Buyer complete The Company and correct copies of (i) all Product INDs its Subsidiaries have been and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND. (b) With respect to the Purchased Assets, Seller is in compliance in all material respects with applicable Health Care Laws. The Company and its Subsidiaries have filed with the Act, applicable Governmental Entities (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 Entity performing functions similar to those performed by the FDA) all required filings, representations, declarations, listings, registrations, reports or submissions. To the Company’s Knowledge, all such filings, representations, declarations, listings, registrations, reports or submissions were in compliance in all material respects with applicable Health Care Laws when filed, and no material deficiency has been asserted by any Pharmaceutical Law applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or initiatingsubmissions. 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 threatening to initiatethe Company’s Knowledge, oral, notice or other material correspondence from any action Governmental Entity, including the FDA or any other Governmental Entity, with respect to suspend or terminate a Product INDany Company Product. In connection with the Purchased Assets, Seller has not andThere is no pending or, to the Knowledge Company’s Knowledge, threatened action, suit, claim, order, injunction, investigation or proceeding of Sellerany nature pending or threatened, Selleror 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 officersKnowledge, employees, agents or clinical investigators acting for Seller have the Company has not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental AuthorityEntity responsible for enforcement or oversight with respect to Health Care Laws, (ii) or failed to disclose a material fact required to be disclosed to the FDA or any other such Governmental Authority Entity. All applications, notifications, submissions, information, claims, reports and statistics and other data that have been utilized, or (iii) committed any other actprepared with the intention to be utilized, made any statement or failed to make any statement, that establishes a reasonable as the basis for the FDA to invoke its Fraud, Untrue Statements of 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 submitted in connection with the Purchased Assets. All such filings, declarations, listings, registrations, reports, applications any regulatory 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 marketing approvals or trials sponsored by or conducted on behalf of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence Permits from the FDA or any other Governmental Authority commencing, or threatening to initiate, 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 Entity relating to the Purchased Assets. As Company Products were true, correct and complete in all material respects as of the date of this Agreementpreparation and submission, there are no ongoing clinical trials as applicable, and any necessary or clinical trial commitments 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 ProductCompany Products, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller nor, to the Knowledge of Seller, any officer, employee, or agent of Seller has been convicted of any crime or is or has been debarred, excluded or disqualified under applicable Health Care Laws, including 21 U.S.C. Section 335a, or, to the Company’s Knowledge has engaged in any conduct in connection with the Purchased Assets that has resulted resulted, or would reasonably be expected to result, in such criminal conviction or could debarment, exclusion or disqualification. To the Company’s Knowledge, no action that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a any such criminal conviction, debarment, exclusion or disqualification are pending or threatened against the Company or any similar Pharmaceutical Law or (iiPerson(s) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are engaged by the Company who have performed work related to the Company Products, and, to the Company’s Knowledge and the Company, there is no claims, actions, proceedings or investigations in connection with the Purchased Assets fact that could reasonably be expected give rise to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigatorsan action.

Regulatory. (a) Seller has made available 7.4.1 PeerStream acknowledges and agrees that YouNow’s performance of its obligations under this Agreement may be subject to Buyer complete and correct copies contingent on the resolution of any regulatory considerations relating to such obligations. 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 to the extent such failure or delay is caused by 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) all Product INDs Peerstream consents to YouNow’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Peerstream Apps in any filings or submissions to the U.S. Securities and Exchange Commission (“SEC”), including any such filings or submissions relating to an offering pursuant to Regulation A of the Securities Act of 1933, as amended (“Regulation A”), or periodic and other reports required to be filed by YouNow with the SEC and (ii) all Purchased Records. All Product INDs are YouNow consents to PeerStream’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Platform in full force any filings or submissions to the SEC, including periodic and effect and there are no facts other reports required to be filed by PeerStream with the SEC. 7.4.3 Any alterations that 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 a material default or noncompliance good faith performance under the Product INDthis Agreement. (b) With respect 7.4.4 While PeerStream may become eligible to receive Props Tokens from 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 Protocol Rewards Engine in the aggregatefuture, have a Material Adverse Effect. Seller has PeerStream acknowledges that this Agreement does not received contemplate any written, or, payments to Seller’s Knowledge, other notice PeerStream from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiatingProtocol Rewards Engine. Further, 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 PeerStream and YouNow acknowledge and agree that: (i) made an untrue statement of a material fact No money or fraudulent statement to other consideration is being solicited in connection with any YouNow offering from the FDA or any other Governmental AuthorityProtocol Rewards Engine, and if sent in response, will not be accepted; (ii) failed No offer to disclose a material fact required to buy Props Tokens can be disclosed accepted and no part of any purchase price can be received in connection with any YouNow offering from the Protocol Rewards Engine until an offering statement is qualified pursuant to the FDA or any other Governmental Authority or Securities Act of 1933, as amended (the “Securities Act”); (iii) committed any other actAny such offer may be withdrawn or revoked, made any statement without obligation or failed to make any statement, that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of 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 Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and 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 initiate, 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. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller nor, to the Knowledge of Seller, any officer, employee, or agent of Seller has been convicted commitment of any crime or engaged in kind, at 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) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any time before notice of its respective officers, employees, agents or clinical investigators.acceptance given after the qualification date; and