LICENSE AND COLLABORATION AGREEMENT

Exhibit 10.30

[***] Certain information in this document has been omitted from this exhibit pursuant to Item 601(b) of Regulation S-K because it is both not material and is the type that the Registrant treats as private or confidential.

LICENSE AND COLLABORATION AGREEMENT

This LICENSE AND COLLABORATION AGREEMENT (this “Agreement”) is entered into as of April 12^th, 2022 (the “Effective Date”) by and between:

XXXX THERAPEUTICS, INC., a corporation organized and existing under the laws of Delaware, with an address at 000 Xxxxxx Xxxx Xxxxxx, Xxx Xxx, XX (“Xxxx”), and

JI XING PHARMACEUTICALS HONG KONG LIMITED, a limited liability company organized and existing under the laws of Hong Kong, with an address at [***], Hong Kong Special Administrative Region (“Ji Xing”).

Xxxx and Xx Xxxx are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Xxxx, a pharmaceutical company, is focused on the discovery, development and commercialization of ophthalmic pharmaceutical products that improve vision;

WHEREAS, Ji Xing is a pharmaceutical company organized to develop and commercialize pharmaceutical products in the greater China region; and

WHEREAS, Xx Xxxx wishes to obtain an exclusive license from Xxxx to develop, manufacture and commercialize the Products in the Territory (each as defined below), and Xxxx is willing to grant such a license to Ji Xing, all in accordance with the terms and conditions set forth herein.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:

1.1 “Active Ingredient” means any clinically active material that provides pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

1.2 “Acquiring Organization” means the Acquirer in an Acquisition Transaction, together with its Affiliates (other than the Target Entity and the Target Entity’s Affiliates immediately prior to the Acquisition Transaction).

1.3 “Acquisition Transaction” means, with respect to an entity (the “Target Entity”), a transaction or series of related transactions pursuant to which a Third Party (an “Acquirer”) directly or indirectly (a) obtains ownership of more than fifty percent (50%) of the voting securities of such the Target Entity, or (b) succeeds to substantially all the assets and business of such Target Entity (whether via merger, sale of assets, or otherwise), provided that if Ji Xing is the Target Entity, [***].

1.4 “Affiliate” means, with respect to a Party, any Person that directly or indirectly controls, is controlled by or is under common control with such Party. As used in this definition, “control” (and, with correlative meanings, the terms “controlled by” and “under common control with”) means, in the case of a corporation, the ownership of fifty percent (50%) or more of the outstanding voting securities thereof or, an interest that results in the ability to direct or cause the direction of the management and policies of such party or the power to appoint fifty percent (50%) or more of the members of the governing body of the party. Notwithstanding the foregoing or any provision to the contrary set forth in this Agreement, Affiliates of Ji Xing shall exclude [***].

1.5 “Anti-Corruption Laws” means all Applicable Laws prohibiting the provision of a financial or other advantage for a corrupt purpose or otherwise in connection with the improper performance of a relevant function, including the U.S. Foreign Corrupt Practices Act (the “FCPA”), Anti-Unfair Competition Law of the PRC and the Criminal Law of the PRC, and similar laws governing corruption and bribery, whether public, commercial or both.

1.6 “Applicable Laws” means all statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority that may be in effect from time to time and applicable to the activities contemplated by this Agreement.

1.7 “Business Day” means a day other than Saturday, Sunday or any day on which banks located in San Diego, U.S., Hong Kong, China, or Beijing, China are obligated to close. Whenever this Agreement refers to a number of days, such number shall refer to calendar days unless Business Days are specified.

1.8 “Calendar Quarter” means the period commencing on January 1 of each Calendar Year and ending on March 31 of the same Calendar Year, the period commencing on April 1 of each Calendar Year and ending on June 30 of the same Calendar Year, the period commencing on July 1 of each Calendar Year and ending on September 30 of the same Calendar Year and the period commencing on October 1 of each Calendar year and ending on December 31 of the same Calendar Year, as the context shall require.

1.9 “Calendar Year” means each twelve (12)-month period commencing on January 1 and ending on December 31.

1.10 “Change of Control” means, with respect to a Party, (a) a merger, reorganization, consolidation or other transaction involving such Party and any entity that is not an Affiliate of such Party as of the Effective Date which results in the voting securities of such Party outstanding immediately prior thereto ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation or other transaction, or (b) any entity that is not an Affiliate of such Party as of the Effective Date becoming the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Party, or (c) any entity that is not an Affiliate of such Party as of the Effective Date acquiring the power (whether through ownership interest, contractual right, or otherwise, including the result of any government action) to direct or cause the direction of the management and policies of such Party.

1.11 “Clinical Trial” means any clinical testing of a Product in human subjects, including, as applicable, Phase 1 Clinical Trial, Phase 2 Clinical Trial and Phase 3 Clinical Trial.

1.12 “CMO” means any Third Party contract manufacturing organization, or any Third Party manufacturer, supplier or seller of a Compound or Product.

1.13 “Code” means Title 11 of the U.S. Code.

1.14 “Commercialization” or “Commercialize” means all activities directed to commercializing, promoting, selling, offering for sale any Compound or Product, and related importing and exporting activities, but excluding Manufacturing.

1.15 “Commercially Reasonable Efforts” means where applied to carrying out specific tasks and obligations of a Party under this Agreement, taking such steps, performing in such a manner and expending (on its own and/or acting through any of its Affiliates, sublicensees or agents) reasonable, diligent, good faith efforts and resources, to accomplish such task or obligation as a well-managed organization of similar size and financial resources and operating in a similar pharmaceutical industry in developed markets would normally use or take to accomplish a similar task or obligation under similar circumstances where it was acting in a diligent, sustained manner to achieve an objective it deems important and in accordance with Applicable Law, taking into account all relevant factors, including measures of patent coverage, relative safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of such product, and the regulatory structure involved. Without limiting the foregoing, where applied to the Development and/or Commercialization of a Product under this Agreement, Commercially Reasonable Efforts must include the use of reasonable,

diligent, good faith efforts and resources, in an active and ongoing program, as normally used by a similarly situated international pharmaceutical company operating in developed markets for a product discovered or identified internally and that it deems important, which product is at a similar stage of development or product life and is of similar market potential. “Commercially Reasonable Efforts” shall, without limiting the foregoing, also require that such Party (on its own and/or acting through any of its Affiliates, sublicensees or subcontractors), at a minimum, (i) promptly assign responsibility for such obligations to qualified personnel (including specific employee(s) who are to be held accountable for progress), set annual goals and objectives for carrying out such obligations, and monitor and hold such personnel accountable for progress with respect to such goals and objectives; (ii) set and seek to achieve specific and meaningful objectives for carrying out such obligations, with timelines consistent with a comparable priority program; and (iii) make and implement decisions and allocate resources designed to diligently and in good faith advance progress with respect to such objectives.

1.16 “Committee” means the JSC, JDC, or any subcommittee established by the JSC, as applicable.

1.17 “Compound” means aceclidine or brimonidine, having the chemical structures set forth in Exhibit A attached hereto, including, in each case, [***].

1.18 “Confidential Information” of a Party means all Know-How, unpublished patent applications and other proprietary and confidential information and data of a financial, commercial, business, scientific or technical nature of such Party that (a) is disclosed by or on behalf of such Party or any of its Affiliates or agents, or is otherwise made available to the other Party or any of its Affiliates, whether made available orally, in writing, electronic or any other form; or (b) is learned by the other Party or comes to the attention of the other Party in connection with the performance of this Agreement by either Party.

1.19 “Control” or “Controlled” means, with respect to any Know-How, Patents or other intellectual property rights, that a Party has the legal authority or right (whether by ownership, license or otherwise) to grant to the other Party a license, sublicense, access or other right (as applicable) under such Know-How, Patents, or other intellectual property rights, on the terms and conditions set forth herein, in each case without breaching the terms of any agreement with a Third Party. Notwithstanding the foregoing, if a Party has a right to grant a license or sublicense with respect to Licensed Patents, Licensed Know-How or other intellectual property rights to the other Party as provided for herein only upon payment of compensation (including, without limitation, milestones or royalties) to a Third Party that would not have been payable had a license or sublicense not been granted or exercised under this Agreement (“Third Party Compensation”), then the first Party will be deemed to have “Control” of the relevant Licensed Patents, Licensed Know-How or other Intellectual Property Rights, only if the other Party agrees to bear the cost of such Third Party Compensation (subject to any permitted reductions under Section 8.5(c)(iii)).

1.20 “Cover”, “Covering” or “Covered” means, when referring to a Compound or a Product, and with respect to a Patent and a Person, that, in the absence of ownership by such Person of, or a license granted to a Person under, a Valid Claim included in such Patent (considering claims of patent applications to be issued as then pending), the research, development, manufacture, sale, offer for sale, or importation of such Compound or Product by such Person would infringe such claim.

1.21 “Development” or “Develop” means all development activities to obtain and maintain Regulatory Approval for a Product, including all pre-clinical studies and Clinical Trials of such Product, distribution of such Product for use in Clinical Trials (including placebos and comparators), statistical analyses, the preparation of Regulatory Materials and all regulatory affairs related to any of the foregoing, but excluding Manufacturing.

1.22 “Dollars” or “$” means U.S. dollars, the lawful currency of the U.S.

1.23 “FDA” means the U.S. Food and Drug Administration or its successor.

1.24 “Field” means all diagnostic, prophylactic and therapeutic uses for the treatment of presbyopia in humans.

1.25 “First Commercial Sale” means, with respect to a Product in any Region, the first sale or transfer of such Product to a Third Party for value by Ji Xing, its Affiliate or sublicensee, including any distribution, use or consumption in such Region, after Regulatory Approval has been obtained for such Product in such Region. For clarity, “First Commercial Sale” shall not include any sale or transfer of any Product prior to receipt of Regulatory Approval, such as so-called “treatment IND sales,” “named patient sales” and “compassionate use sales.”

1.26 “GAAP” means, with respect to a person or entity’s accounting standard in a country or jurisdiction, (a) if in regards to the U.S., U.S. generally accepted accounting principles, (b) if in regards to mainland China, the PRC generally accepted accounting principles, (c) if in regard to any country or jurisdiction other than the U.S. and mainland China, either (i) the International Financial Reporting Standards issued by the International Financial Reporting Standards Foundation and the International Accounting Standards Board, or (ii) the applicable accounting standards as published by the preeminent accounting society for that country or jurisdiction and followed by such person or entity, in each case of (a), (b) and (c), consistently applied and that provide for, among other things, assurance that the accounting and reported results are credible and accurate.

1.27 “GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable, (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) as set forth in the then current clinical laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

1.28 “Generic Product” means, with respect to a Product in a particular Region in the Territory, any pharmaceutical product that (a) contains the same [***] of Active Ingredients as such Product [***] as such Product; (b) [***] in such Region ([***] in such Region) [***] in such Region; (c) is [***], if required and as determined by [***]; and (d) is sold in such Region by a Third Party that is not a sublicensee of Ji Xing or its Affiliates and did not purchase such product in a chain of distribution that included any of Ji Xing or its Affiliates or sublicensees.

1.29 “GLP” means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the region in the Territory, each as may be amended and applicable from time to time and, in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

1.30 “Governmental Authority” means any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, region, state or local authority or any political subdivision thereof, or any association of countries.

1.31 “IND” means any investigational new drug application, clinical trial application, clinical trial exemption or similar or equivalent application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

1.32 “Initiation” means, with respect to a Clinical Trial of a Product, the first dosing of the first human subject for such Clinical Trial.

1.33 “Invention” means any invention, process, method, composition of matter, article of manufacture, discovery or finding, patentable or otherwise, that is conceived, made, developed, reduced to practice or otherwise invented as a result of a Party (or the Parties jointly) exercising its (their) rights or carrying out its (their) obligations under this Agreement, whether directly or via its Affiliates, sublicensees, agents or contractors, including all rights, title and interest in and to the intellectual property rights therein.

1.34 “Ji Xing Improvements” means the Inventions created by or on behalf of Xx Xxxx, its Affiliates or sublicensees (for clarity, other than by Xxxx, other Xxxx Licensees or any of their respective Affiliates) that relate to any Compound or Product (and all intellectual property rights therein and thereto) through fulfillment of its obligations or exercise of its rights under this Agreement or applicable sublicense agreement.

1.35 “Know-How” means any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.

1.36 “Xxxx Acquirer IP” means all Know-How and Patents Controlled by an Acquiring Organization of Xxxx, except for: (a) Licensed Know-How and Licensed Patents immediately prior to the Acquisition of Xxxx; and (b) Know-How (and Patents claiming such Know-How), in each case, that are both: (i) used by Xxxx or such Acquiring Organization after such Acquisition of Xxxx in connection with the Development of a Product for the Field; and (ii) created after such Acquisition by personnel of such Acquiring Organization that are not Segregated from Licensed Know-How disclosed by Xxxx to such Acquiring Organization (other than Licensed Know-How that (a) is already rightfully known to the Acquiring Organization (other than under an obligation of confidentiality at least as stringent as required in this Agreement) at the time of disclosure (as evidenced by written records of the Acquiring Organization); (b) is or becomes generally available to the public other than through any act or omission of the Acquiring Organization; (c) is disclosed to the Acquiring Organization without an obligation of confidentiality by a Third Party who had no separate nondisclosure obligation in respect of such information; or (d) is independently discovered or developed by or on behalf of the Acquiring Organization without the use of or reference to the such Licensed Know-How (as evidenced by written records of the Acquiring Organization).

1.37 “Xxxx Licensees” means any and all licensees and sublicensees of Xxxx or any of Xxxx’x Affiliates to whom Xxxx or Xxxx’x Affiliates have granted rights in the Products (other than Xx Xxxx, Xx Xxxx’s Affiliates and sublicensees).

1.38 “Licensed IP” means Licensed Know-How and Licensed Patents.

1.39 “Licensed Know-How” means all Know-How Controlled by Xxxx or its Affiliates as of the Effective Date or at any time during the Term that is necessary or reasonably useful for the Development, Manufacture or Commercialization of the Product in the Field in the Territory. Notwithstanding the foregoing, Licensed Know-How excludes: (a) [***]; and (b) [***].

1.40 “Licensed Patents” means all Patents in the Territory Controlled by Xxxx or its Affiliates as of the Effective Date or at any time during the Term that relate to or otherwise Cover the Development, Manufacture or Commercialization of the Product in the Field in the Territory. Notwithstanding the foregoing, Licensed Patents exclude: (i) [***]: (A) [***]; and (B) [***]; and (ii) [***].

1.41 “Manufacture” and “Manufacturing” mean activities directed to manufacturing, processing, filling, finishing, packaging, labeling, quality control, quality assurance testing and release, post-marketing validation testing, inventory control and management, storing and transporting any Compound or the Product.

1.42 “Manufacturing Cost” means, with respect to a Compound or Product supplied by Xxxx to Xx Xxxx hereunder:

(a) if the Compound or Product is [***], (i) [***], plus (ii) [***]; and

(b) if the Compound or Product is [***] (i) [***]; and (ii) [***].

1.43 “Marketing Materials” means any packaging, labels, advertising, point-of-purchase, and other publicly disclosed marketing, promotional, or commercialization literature and materials Controlled by Xxxx pertaining to any Product and approved by Xxxx (such approval not to be unreasonably withheld, conditioned or delayed) for use by Xx Xxxx hereunder.

1.44 “NDA” means a New Drug Application, as defined by the FDA, or equivalent application for approval (but not including pricing and reimbursement approvals) to market a pharmaceutical product in a country or jurisdiction outside the U.S.

1.45 “Net Sales” means the [***] on all sales, offers or other provision of any and all Products by Xx Xxxx, its Affiliates, or sublicensees, less the following deductions with respect to the sale of such Product, to the extent reasonable, customary and directly allocable to such Product:

(a) [***];

(b) [***];

(d) [***];

(e) [***]; and

(f) [***]; and

(g) [***].

Each of the amounts set forth above shall be determined in accordance with GAAP and substantiated by or from the books and records of Xx Xxxx, its Affiliate or sublicensee, maintained in accordance with GAAP consistently applied. For the avoidance of doubt, if a single item falls into more than one of the categories set forth in clauses (a)-(d) above, such item may not be deducted more than once. For clarity, sales of Product(s) between Xx Xxxx, its Affiliates and sublicensees for resale shall be excluded from Net Sales, but the subsequent resale of Product shall be included in Net Sales.

With respect to any sale of a Product [***].

Sales between Ji Xing and its Affiliates and sublicensees for resale shall be disregarded for purposes of calculating Net Sales, except if such purchaser is an end user, but the subsequent resale of Product shall be included in Net Sales. Net Sales also exclude any sale or transfer of any Product for free or below cost in early access, compassionate use or named patient programs.

Notwithstanding the foregoing, Net Sales shall not include amounts (whether actually existing or deemed to exist for purposes of calculation) for Products distributed for use in Clinical Trials.

1.46 “NMPA” means National Medicine Products Administration of China (formerly known as the China Food and Drug Administration), or its successor.

1.47 “Patents” means all national, regional and international patents and patent applications, including divisions, continuations, continuations-in-part, additions, re-issues, renewals, extensions, substitutions, re-examinations or restorations, registrations and revalidations, and supplementary protection certificates and equivalents to any of the foregoing.

1.48 “Payable Sublicense” shall mean (a) a sublicense granted to a Third Party by Xx Xxxx or its Affiliate of any rights to any Licensed IP (or sale of a covenant not to sue), (b) an assignment to a Third Party by Xx Xxxx or its Affiliate (other than in connection with a Change of Control of Xx Xxxx) of any rights to any Licensed IP, or (c) the grant to a Third Party by Xx Xxxx or its Affiliate of an option to acquire any of the foregoing, in each case with respect to a Compound or Product. Notwithstanding the foregoing, Payable Sublicense excludes agreements with Third Parties for any Change

of Control of Xx Xxxx, distributors of a Product in the ordinary course of trade, contract manufacturing organizations (CMOs), contract research organizations (CROs), academic research organizations (AROs) and other contractors, or academic, non-profit or governmental entities, in each case where (i) the agreement counterparty is performing services for or collaborating with Xx Xxxx and the counterparty and its Affiliates are not granted any Commercialization rights of any kind with respect to any Licensed IP or a Product (including options for Commercialization rights and whether pursuant to the same or under a different agreement) and (ii) no revenue will be received by Xx Xxxx or its Affiliates.

1.49 “Person” means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization or a Governmental Authority.

1.50 “Phase 1 Clinical Trial” means any human clinical trial of a Product that would satisfy the requirements of 21 § CFR 312.21(a) or corresponding foreign regulations.

1.51 “Phase 2 Clinical Trial” means any human clinical trial of a Product that would satisfy the requirements of 21 § CFR 312.21(b) or corresponding foreign regulations.

1.52 “Phase 3 Clinical Trial” means any human clinical trial of a Product that would satisfy the requirements of 21 § CFR 312.21(c) or corresponding foreign regulations.

1.53 “Pivotal Clinical Trial” means any human clinical trial of a Product that is intended (as of the time of Initiation of such clinical trial) to obtain the results and data to support the filing of an NDA (including label expansion but excluding the data that may be necessary to support the pricing and/or reimbursement approval), including so called Phase 2/3 trials and any human clinical trial that would satisfy the requirements of 21 § CFR 312.21(c) or corresponding foreign regulations. [***].

1.54 “Privacy Laws” means all Applicable Laws governing the receipt, collection, compilation, use, storage, processing, sharing, safeguarding, security, disclosure or transfer of protected health information and other personal information, including the Health Insurance Portability and Accountability Act, the Family Educational Rights and Privacy Act, and the Identify Theft Enforcement and Protection Act.

1.55 “Product” means (a) the pharmaceutical product containing a Compound known as “LNZ100” (formulated as of the Effective Date as 1.75% aceclidine) as further described in Exhibit A, (b) the pharmaceutical product containing a Compound known as “LNZ101” (formulated as of the Effective Date as 1.75% aceclidine + 0.08% brimonidine ophthalmic solution) as further described in Exhibit A, or (c) for each of (a) or (b) above, if, (i) during the Term, changes are made by Xxxx to the concentration of the Compounds, composition or concentration of the excipients, or (ii) Xxxx alters

either (a) or (b) prior to the first Regulatory Approval of such product by adding any new Active Ingredient(s) to the Compound(s) of such product, and in each of (i) and (ii) above, such derivations are intended for use consistent with the Field, then such derivations to the extent Controlled by Xxxx; provided, that the term “Products” expressly excludes any current or future products of Xxxx or its Affiliates: (1) not containing the Compound, (2) containing any additional or different Active Ingredients than those specified in (a) or (b) above unless such additional Active Ingredient is added by Xxxx prior to the first Regulatory Approval of the applicable product (in which case shall be included herein pursuant to (c)(ii) above), (3) that would reasonably be expected to require additional Phase III Clinical Trial(s) in order to commercialize such product after the FDA has already approved a Product of Xxxx in the Field, or (4) containing derivations of the Compound for use outside the Field, and, for clarity, all such products other than those described in this definition shall not be considered a Product.

1.56 “Regulatory Approval” means, with respect to a Product in a country or jurisdiction, all approvals from the Regulatory Authorities necessary to market and sell such Product in such country or jurisdiction, including pricing and reimbursement approval.

1.57 “Regulatory Authority” means any applicable Governmental Authority responsible for granting Regulatory Approvals for Product, including the FDA, NMPA, and any corresponding national or regional regulatory authorities.

1.58 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights (other than Patents) conferred by any Regulatory Authority with respect to a pharmaceutical or medical product, including without limitation [***].

1.59 “Regulatory Materials” means any regulatory application, submission, notification, communication, correspondence, registration, approval and other documents and filings made to, received from or otherwise conducted with a Regulatory Authority regarding the Product, including any NDA and Regulatory Approval.

1.60 “Segregate” means, with respect to a particular Competing Product, to use reasonable efforts to segregate the research, development and commercialization activities relating to such Competing Product from the Development and Commercialization activities relating to the Compound or any Product under this Agreement, including putting in place appropriate firewalls that are reasonably designed to ensure that: (a) no personnel involved in performing the research, development or commercialization of such Competing Product have access to non-public plans, non-public information or any other relevant Confidential Information of the applicable Party relating to the Development or Commercialization of the Compound or any Product under this Agreement; (b) no Licensed IP or Product Inventions is used or practiced in connection with the research, development or commercialization of such Competing Product; and (c) no personnel involved in performing the Development or Commercialization of the Compound or any Product

under this Agreement have access to non-public plans or non-public information relating to the research, development or commercialization of such Competing Product; provided, that, in each case of (a), (b) or (c), senior management personnel may review and evaluate plans and information regarding the research, development and commercialization of such Competing Product solely in connection with monitoring the progress of products including portfolio decision-making among product opportunities.

1.61 “Sublicensing Income” means all consideration actually received by Xx Xxxx or its Affiliates from any Person from or pursuant to a Payable Sublicense, excluding only:

(a) [***];

(b) [***];

(d) [***];

(e) [***];

(f) [***]; and

(g) [***].

1.62 “Territory” means the People’s Republic of China (the “PRC”), including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan, each of which shall be referred to as a “Region”.

1.63 “Third Party” means an entity other than Xxxx, Xx Xxxx and Affiliates of either of them.

1.64 “U.S.” means United States of America, including all possessions and territories thereof.

1.65 “Upstream Licenses” means any and all agreements between Xxxx or any of its Affiliates, on the one hand, and any Third Party (the “Upstream Licensor”), on the other hand, pursuant to which Xxxx has in-licensed any Patent or material Know-How owned or Controlled by such Upstream Licensor that are included as part of the Licensed Patents or Licensed Know-How, including any of the foregoing pursuant to which Xxxx or any of its Affiliates agreed to provisions that would require Xx Xxxx to make any payments (including royalties) to any Third Party.

1.66 “Valid Claim” means a claim of a pending patent application or an issued and unexpired Patent (as may be extended through supplementary protection certificate or patent term extension or the like) that has not been revoked, held invalid or unenforceable by a patent office,

court or other Governmental Authority of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise; provided that [***].

1.67 Additional Definitions. The following table identifies the location of definitions set forth in various Sections of this Agreement:


Defined Terms		Section
Audited Party		Section 11.4(c)
Auditing Party		Section 11.4(c)
Acquirer		Section 1.3
Agreement		Preamble
Alliance Manager		Section 3.1
Clinical Supply Agreement		Section 6.4
Commercial Supply Agreement		Section 6.5
Competing Product		Section 2.7(a)
Development Plan		Section 4.3
Effective Date		Preamble
Executive Officers		Section 3.2
FCPA Covered Person		Section 11.4
ICC		Section 14.3(a)
Indemnified Party		Section 12.3
Indemnifying Party		Section 12.3
Initial Technology Transfer		Section 4.4(a)
Initial Technology Transfer Materials		Section 4.4(a)
Initial Technology Transfer Plan		Section 4.4(a)
JDC		Section 3.3
Ji Xing		Preamble
Xx Xxxx Xxxxxxxxxx(s)		Section 12.2
Joint Development Committee		Section 3.3
Joint Inventions		Section 9.1(a)(i)
Joint Patents		Section 9.2(a)
Joint Steering Committee		Section 3.2
JSC		Section 3.2
License		Section 2.1(b)
Losses		Section 12.1
Xxxx		Preamble
Xxxx Indemnitee(s)		Section 12.1


Defined Terms		Section
Xxxx Trademarks		Section 9.6(b)
Manufacture Technology Transfer		Section 6.2
Manufacturing Technology Transfer Materials		Section 6.2
Manufacturing Technology Transfer Plan		Section 6.2
Other Product		Section 2.8(a)
Other Product Transaction		Section 2.8(a)
Parties		Preamble
Party		Preamble
Pharmacovigilance Agreement		Section 5.6
Prior CDA		Section 10.6
Product Infringement		Section 9.3(b)
Product Marks		Section 9.6(a)
Region		Section 1.62
Remedial Action		Section 5.9
ROFN		Section 2.8(a)
ROFN Exercise Period		Section 2.8(b)
ROFN Expiry Date		Section 2.8(c)
ROFN Negotiation Period		Section 2.8(a)
Royalty Term		Section 8.5(b)
[***]		[***]
[***]		[***]
SEC		Section 10.5(b)
Sole Inventions		Section 9.1(a)(i)
Target Entity		Section 1.3
Taxes		Section 8.10
Term		Section 13.1(a)

ARTICLE 2

LICENSES

2.1 License Grant to Xx Xxxx. Subject to the terms and conditions of this Agreement, Xxxx hereby grants to Xx Xxxx:

(a) an exclusive (even as to Xxxx but subject to Xxxx’x retained rights as set forth herein, including in Sections 2.3 and 2.7(b)), royalty-bearing, nontransferable (except in accordance with Section 15.2) license, during the Term, with the right to grant sublicenses as provided in Section 2.2 below (through multiple tiers consistent with Section 2.2) solely in accordance with Section 2.2), under the Licensed IP to Develop, use, import, sell, offer for sale and otherwise Commercialize the Compounds and Products in the Field in the Territory; and

(b) a non-exclusive, nontransferable (except in accordance with Section 15.2) license, during the Term, with the right to grant sublicenses through multiple tiers solely in accordance with Section 2.2, under the Licensed IP to Manufacture the Compounds and Products in the Territory, solely for the purposes set forth in Section 2.1(a) and subject to the conditions and restrictions set forth in Article 6 ((Section 2.1(a) and Section 2.1(b)) collectively, the “License”).

2.2 Right to Sublicense.

(a) Subject to the terms and conditions of this Agreement, Xx Xxxx shall have the right to grant sublicenses (through multiple tiers consistent with this Section 2.2) of the license granted to it under Section 2.1, (i) to any Affiliate [***], which, for clarity, expressly excludes [***]; and (ii) from [***].

(b) Each sublicense under the Licensed IP (including each downstream tier of sublicense thereunder) shall be subject to a written agreement that is consistent with the terms and conditions of this Agreement. Without limiting the foregoing, each sublicense shall contain at least the following terms and conditions: (i) [***]; and (ii) [***]. Xx Xxxx shall provide a copy of each sublicense agreement to Xxxx within [***] after the grant of a sublicense, provided that Xx Xxxx shall be permitted to redact sensitive or proprietary information from any such agreement which terms are not necessary for Xxxx to confirm Xx Xxxx’s compliance with its obligations hereunder, and such sublicense agreement shall be treated as Xx Xxxx’s Confidential Information. Xx Xxxx shall remain directly responsible for all of its obligations under this Agreement, including without limitation those that have been delegated or sublicensed to any sublicensee. [***]. Xx Xxxx shall not grant a sublicense to any sublicensee that has been debarred or disqualified by a Regulatory Authority.

2.3 Xxxx Retained Rights. Notwithstanding the exclusive license granted to Xx Xxxx under Section 2.1(a), Xxxx hereby expressly retains (a) the rights to use the Licensed IP in the Field in the Territory to perform its obligations under this Agreement, and (b) [***]. For clarity, Xxxx retains the exclusive right to practice, license and otherwise exploit the Compounds and Products outside the scope of the license granted to Ji Xing under Section 2.1, including the exclusive right (i) to Develop, Manufacture and Commercialize the Products (A) outside of the Field in the Territory and (B) for all uses and fields outside the Territory.

2.4 [***]

2.5 No Implied Licenses; Negative Covenant. Except as set forth herein, neither Party shall acquire any license or other right or interest, by implication or otherwise, under any Know-How, Patent or other intellectual property of the other Party. Ji Xing shall not, and shall not permit any of its

Affiliates or sublicensees to, practice any Licensed IP outside the scope of the license granted by Xxxx to Ji Xing under Section 2.1 of this Agreement, outside of the Territory or outside of the Field.

2.6 No Diversion.

(a) Ji Xing hereby covenants and agrees that it shall not, and shall ensure that its Affiliates and sublicensees shall not, either directly or indirectly, promote, market, distribute, import, sell or have sold any Product, including via the Internet or mail order, to any Third Party or to any address or Internet Protocol address or the like outside of the Territory or to any Third Party that such Party knows (or reasonably should know after due inquiry) has previously exported or is likely to export the Products outside of the Territory. Ji Xing shall not engage, nor permit its Affiliates and sublicensees to engage, in any advertising or promotional activities relating to any Product for use directed primarily to customers or other buyers or users of such Product located in any country or jurisdiction outside of the Territory, or solicit orders from any prospective purchaser located in any country or jurisdiction outside of the Territory. If Ji Xing or its Affiliates or sublicensees receive any order for any Product from a prospective purchaser located in a country or jurisdiction outside of the Territory, Ji Xing shall immediately refer that order to Xxxx and shall not accept any such orders. Xxxx hereby covenants and agrees that, during the Term, it shall not, and shall ensure that its Affiliates and sublicensees shall not, either directly or indirectly, distribute, import, sell or have sold any Product, to any Third Party in the Territory, [***].

(b) Neither Party shall, nor permit its Affiliates and sublicensees to, deliver or tender (or cause to be delivered or tendered) any Product to any Third Party for use in or distribution into the other Party’s territory [***].

2.7 Non-Compete.

(a) During the Term, neither Xx Xxxx nor any of its Affiliates shall, [***].

(b) During the Term, subject to Section 2.7(c), neither Xxxx nor, subject to Sections 2.7(e) and 15.2(c), any of its Affiliates shall, [***].

(d) For clarity, [***].

(e) Notwithstanding anything to the contrary, nothing contained in this Agreement (including this Section 2.7 nor Section 2.8) shall be deemed to prohibit (i) any Acquiror of Xxxx from consummating an Acquisition Transaction of Xxxx (or of any of Xxxx’x Affiliates), (ii) any Acquirer or any other Acquiring Organization from engaging in any activity restricted under this Section 2.7 or under Sections 2.8, or (iii) Xxxx or its Affiliates from providing product development services to any Person engaged in any such restricted activity provided that Xxxx shall not knowingly enable or assist

such Person to engage in any such restricted activity, further provided that for each of (ii) or (iii) above, (A) such activities shall not infringe Patent rights owned by Xx Xxxx, and (B) any employees or other Persons directly engaged in any such activities by or on behalf of Xxxx or its Affiliates (including any such Acquirer or Acquiring Organization of Xxxx) (as applicable) shall not be, and are prohibited from in any way, using any intellectual property or proprietary information or materials of Xx Xxxx received by Xxxx xxxxxxxxx (for use in connection with the activities performed under this Agreement) in any such activity.

2.8 Other Product Transaction.

(a) If during the Term, Xxxx is developing or commercializing a different product containing a Compound for any indications or use outside the Field (such product, the “Other Product”) and Xxxx is contemplating a potential regional collaboration inclusive of mainland China to develop and commercialize such Other Product (an “Other Product Transaction”), then Ji Xing shall have, and Xxxx hereby grants to Xx Xxxx, a right of first negotiation during the Term to negotiate exclusively in good faith for a period of [***] (the “ROFN Negotiation Period”) to obtain a China regional license with respect to such Other Product (the “ROFN”). Notwithstanding the foregoing, if [***].

(b) Xxxx shall notify Xx Xxxx of such intention described above in Section 2.8(a) in writing prior to entering into any definitive agreement with any Third Party regarding such Other Product Transaction, and the indication(s) or use(s) for such Other Product Transaction. Xx Xxxx may exercise the ROFN by notifying Xxxx in writing within [***] after receiving Xxxx’x notice (the “ROFN Exercise Period”), and upon Xx Xxxx’s exercise of the ROFN, the Parties shall negotiate exclusively in good faith during the ROFN Negotiation Period the terms of a binding written agreement that grants Xx Xxxx the right to develop, manufacture, or commercialize the Other Product in the Territory for such indication(s) or use(es) on mutually agreeable terms.

(c) If Xx Xxxx does not exercise the ROFN within the ROFN Exercise Period, or the Parties fail to reach a binding agreement during the ROFN Negotiation Period, then the ROFN with respect to such indication(s) or use(es) shall expire, as applicable, on the last day of the ROFN Exercise Period or the ROFN Negotiation Period (such date, the “ROFN Expiry Date”), and Xxxx and its Affiliates shall be free to pursue and consummate such Other Product Transaction. For clarity, Xx Xxxx’s ROFN shall be for the Territory only, and does not include any transaction that Xxxx enters into with a Third Party to develop, manufacture, or commercialize the Other Product in any country or jurisdiction outside the Territory, which Xxxx may enter into with such Third Party without notifying or negotiating with Xx Xxxx first.

2.9 Performance by Subcontractors. Subject to the terms and conditions of this Agreement, Xx Xxxx may engage subcontractors for purposes of conducting Development, Manufacture, Commercialization and other activities for Ji Xing under this Agreement, provided that any such subcontractor

is bound by a written agreement that is consistent with the terms and conditions of this Agreement (including those relating to confidentiality, intellectual property rights and compliance). Xx Xxxx shall remain directly responsible for any obligations under this Agreement that have been delegated or subcontracted to any subcontractor, and shall be directly responsible for the performance of its subcontractors.

ARTICLE 3

GOVERNANCE

3.1 Alliance Managers. Within [***] after the Effective Date, each Party shall appoint (and notify the other Party of the identity of) a representative having the appropriate qualifications (including a general understanding of pharmaceutical development, manufacture and commercialization issues) to act as its alliance manager under this Agreement (the “Alliance Manager”). The Alliance Managers shall facilitate the flow of information and otherwise promote communication, coordination and collaboration between the Parties and raise cross-Party and/or cross-functional issues in a timely manner. Each Party may replace its Alliance Manager by written notice to the other Party.

3.2 Joint Steering Committee. The Parties hereby establish a joint steering committee (the “Joint Steering Committee” or the “JSC”) to manage the overall collaboration of the Parties under this Agreement, which committee shall include the Chief Executive Officer of Xxxx and the Chief Executive Officer of Xx Xxxx (the “Executive Officers”). The JSC shall in particular (a) review and discuss the overall strategy for the Development, Manufacture and Commercialization of the Products in the Field in the Territory; (b) provide a forum for the discussion and coordination of the Parties’ activities under this Agreement; (c) direct and oversee the operation of the JDC and any other joint subcommittee established by JSC, including resolving any disputed matter of the JDC and other joint subcommittees; (d) establish other joint subcommittees as necessary or advisable to further the purpose of this Agreement; and (e) perform such other functions as expressly set forth in this Agreement or allocated to it by the Parties’ written agreement.

3.3 Joint Development Committee. The Parties hereby establish a joint development committee (the “Joint Development Committee” or the “JDC”) to oversee the Development of the Products in the Field in the Territory under this Agreement, which committee shall be comprised of [***] representatives from each Party. Each Party shall appoint its JDC representatives within [***] after the Effective Date. The JDC shall in particular: (a) review, discuss and approve the Development Plan and amendments thereto; (b) review and discuss the progress and results of the Development of the Products in the Field in the Territory; (c) provide a forum for and facilitate communications between the Parties with respect to the Development of the Product and coordination of the Development of Products within and outside the Territory; (d) coordinate [***]; and (e) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Development of the Product, as directed by the JSC.

3.4 Limitation of Authority. Each Committee shall only have the powers expressly assigned to it in this Article 3 and elsewhere in this Agreement and shall not have the authority to (a) modify or amend the terms and conditions of this Agreement; (b) waive either Party’s compliance with the terms and conditions of this Agreement; or (c) determine any such issue in a manner that would conflict with the express terms and conditions of this Agreement.

3.5 Committee Members. Each Party’s representatives on the Committees shall be an officer or employee of the applicable Party or its Affiliates ([***]) and provided further that any such [***] is bound by written obligations of confidentiality and non-use with respect to Confidential Information of Xxxx consistent with Xx Xxxx’s obligations under this Agreement) having sufficient seniority within such Party to make decisions arising within the scope of the applicable Committee’s responsibilities. Each Party may replace its representatives on any Committee upon written notice to the other Party. Each Party shall appoint one of its representatives on each Committee to act as a co-chairperson of such Committee.

3.6 Meetings. Each Committee shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than [***]. Each Party may call additional ad hoc Committee meetings as the needs arise with reasonable advance notice to the other Party. Meetings of any Committee may be held in person, by audio or video teleconference. In-person Committee meetings shall be held at locations selected alternatively by the Parties. The co-chairpersons of the applicable Committee shall jointly prepare the agenda and minutes for each Committee meeting. Each Party shall be responsible for all of its own expenses of participating in the Committee meetings. No action taken at any Committee meeting shall be effective unless at least [***] of each Party is participating in such Committee meeting.

3.7 Non-Member Attendance. Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend any Committee meeting in a non-voting capacity; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Party shall provide prior written notice to the other Party. Such Party shall also ensure that such Third Party is bound by confidentiality and non-use obligations consistent with the terms of this Agreement.

3.8 Decision-Making. All decisions of each Committee shall be made by unanimous vote, with each Party’s representatives collectively having one vote. If, after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JDC or any subcommittee established by the JSC, the representatives of the Parties on such Committee cannot reach an unanimous decision as to such matter within [***] after a Party has requested resolution of such matter by such Committee, such matter shall be referred to the JSC for resolution. If, after reasonable discussion

and good faith consideration of each Party’s view on a particular matter before the JSC (including any matter referred to the JSC by the JDC or any subcommittee established by the JSC), the representatives of the Parties on the JSC cannot reach an unanimous decision as to such matter within [***] after a Party has requested resolution of such matter by the JSC, then:

(a) [***].

(b) Notwithstanding the foregoing, [***]:

(i) [***]; or

(ii) [***].

3.9 Discontinuation of Committees. The activities to be performed by each Committee shall solely relate to governance under this Agreement, and are not intended to be or involve the delivery of services. Each Committee shall continue to exist until the first to occur of (a) the Parties mutually agreeing to disband such Committee; or (b) Xxxx providing written notice to Xx Xxxx of its intention to disband and no longer participate in such Committee. Once the Parties mutually agree or Xxxx has provided written notice to disband any Committee, such Committee shall have no further obligations under this Agreement and, thereafter, the Alliance Managers shall be the contact persons for the exchange of information under this Agreement, and decisions of such Committee shall be decisions as between the Parties, subject to the same respective decision-making rights and limitations set forth in Section 3.8 and other terms and conditions of this Agreement.

ARTICLE 4

DEVELOPMENT

4.1 General. Subject to the terms and conditions of this Agreement, Xx Xxxx shall be responsible for the Development of the Products in the Field in the Territory, including the performance of Clinical Trials of the Products in the Field in the Territory necessary for Regulatory Approval. Xx Xxxx shall be solely responsible for all the costs and expenses it incurs to Develop the Products in the Territory.

4.2 Development Diligence. Ji Xing shall, directly or through one or more Affiliates or sublicensees, use Commercially Reasonable Efforts to Develop and obtain and maintain Regulatory Approval for the Product in the Field in each Region within the Territory, provided that, under this Section 4.2, if, at any time during the Term, [***], then [***], provided, that, [***].

4.3 Development Plan. All Development of the Products by or on behalf of Xx Xxxx under this Agreement shall be conducted pursuant to a high-level written Development plan that sets forth the timeline and other aspects of all clinical and regulatory activities to be conducted by or on behalf of Xx Xxxx to obtain Regulatory Approval of the Products in the Field in each Region in the Territory (the “Development Plan”). Within a reasonable period following the Effective Date, Xx Xxxx shall present a draft of the initial Development Plan to the JDC for review, discussion and approval. Once approved by the JDC, such Development Plan shall become effective. From time to time, but at least once every [***], Xx Xxxx shall propose updates or amendments to the Development Plan in consultation with Xxxx and submit such proposed updated or amended plan to the JDC for review, discussion and approval. Once approved by the JDC, the updated or amended Development Plan shall become effective.

4.4 Technology Transfer.

(a) The Parties have agreed upon an initial technology transfer plan which specifies the scope of Xxxx’x responsibilities and anticipated timelines for such technology transfer, pursuant to which Xxxx will, at its cost, provide Xx Xxxx with access (via transfer of electronic records in the English language) to a defined definitive list of Licensed Know-How and Regulatory Materials listed on Schedule 4.4 in Xxxx’x possession and Control (such listed material, the “Initial Technology Transfer Materials”; the transfer of the Initial Technology Transfer Material, the “Initial Technology Transfer”; and such plan, the “Initial Technology Transfer Plan”, which is attached as Exhibit C hereto). Notwithstanding the foregoing, [***]. After Xxxx transfers the Initial Technology Transfer Materials to Xx Xxxx, Xx Xxxx may request Xxxx to provide additional Licensed Know-How or Regulatory Materials that Xx Xxxx reasonably believes is in Xxxx’x possession and Control and is missing, and Xxxx shall consider such requests in good faith and to the extent Xxxx confirms that such information or materials are in Xxxx’x possession and Control and are necessary or reasonably useful to be transferred to Xx Xxxx, then Xxxx will use Commercially Reasonable Efforts to provide such additional information or materials as promptly as practicable at Xx Xxxx’s cost and expense. Following the Initial Technology Transfer, Xxxx shall consider in good faith any subsequent requests by Xx Xxxx to provide Xx Xxxx with additional, reasonable technical and regulatory assistance, as may be reasonably available from Xxxx and necessary or reasonably useful to enable Xx Xxxx to understand and use such Licensed Know-How or Regulatory Materials for the purposes contemplated herein in connection with the Development of the Products, at Ji Xing’s cost and expense, which may include providing reasonable access to Xxxx’x personnel involved in the research and Development of the Products as reasonably needed.

(b) During the Term, Xxxx shall use Commercially Reasonable Efforts to, keep Xx Xxxx reasonably informed as to any Know-How (in addition to the Initial Technology Transfer Materials) that qualifies as Licensed Know-How or Regulatory Materials that Xxxx or its Affiliates Controls or comes into Xxxx’x or its Affiliates’ s Control (including any data resulting from the Development of the Products conducted by or on behalf of Xxxx,

its Affiliates or Xxxx Licensees (to the extent permitted) in the Field outside the Territory that Xxxx reasonably believes to be relevant to the exercise of Xx Xxxx’s rights within the Territory) and provide Xx Xxxx with access to such additional Know-How or Regulatory Materials at Xx Xxxx’s cost. Xxxx shall, at Xx Xxxx’s cost, provide Xx Xxxx with reasonable technical and regulatory assistance to help Xx Xxxx understand and use such additional Know-How and Regulatory Materials in connection with the Development of the Products in the Field in the Territory, which may include providing reasonable access to Xxxx’x personnel involved in the research and Development of the Products as reasonably needed.

4.5 Data Exchange and Use. In addition to its adverse event and safety data reporting obligations pursuant to Section 5.6, as permitted under Applicable Laws, each Party shall promptly provide the other Party with copies of all data and results and all supporting documentation (e.g., protocols, CRFs, analysis plans) generated from its Development of the Products in the Field in its territory, in each case that is Controlled by such Party and to the extent permitted under Applicable Laws. Xx Xxxx shall have the right to use the data provided by Xxxx for the purpose of obtaining and maintaining Regulatory Approval for and Commercializing the Products in the Field in the Territory. Xxxx shall have the right to use the data provided by Xx Xxxx for the purpose of obtaining and maintaining Regulatory Approval for and Commercializing the Products outside the Territory.

4.6 Development Records. Xx Xxxx shall maintain complete, current and accurate records of all Development activities conducted by or on behalf of Xx Xxxx xxxxxxxxx, and all data and other information resulting from such activities. Such records shall properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Xx Xxxx shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and applicable national and international guidelines (e.g., GCP and GLP). Xxxx shall have the right to review and copy such records maintained by Xx Xxxx at reasonable times and to use such records and obtain access to the originals for its research and development activities and regulatory and patent purposes or for other legal proceedings.

4.7 Development Reports. Xx Xxxx shall keep Xxxx reasonably informed as to the progress and results of its and its Affiliates’ and sublicensees’ Development of the Products. Without limiting the foregoing, the status, progress and results of the Development of the Products in the Territory shall be discussed at meetings of the JDC. At least [***] before each regularly scheduled JDC meeting, Xx Xxxx shall provide the JDC with a written report summarizing its Development activities and the results thereof, covering subject matter at a level of detail reasonably required by Xxxx. In addition, Xx Xxxx shall make available to Xxxx such additional information about its Development activities as may be reasonably requested by Xxxx from time to time.

ARTICLE 5

REGULATORY

5.1 General. The Development Plan shall set forth the regulatory strategy for seeking Regulatory Approvals of the Products in the Field in each Region in the Territory. Xx Xxxx shall be responsible for obtaining and maintaining Regulatory Approvals of the Products in the Field in the Territory at Xx Xxxx’s own cost and expense and in accordance with the regulatory strategy set forth in the Development Plan. Through the JDC, Xx Xxxx shall keep Xxxx informed of regulatory developments related to the Products in the Territory, including any decision by any Regulatory Authority in the Territory regarding the Products.

5.2 Regulatory Approval Holder. Subject to Applicable Laws, Ji Xing shall apply for Regulatory Approvals of the Products in the Field in each Region in the Territory in its own name, and Ji Xing (or an Affiliate or a permitted sublicensee of Ji Xing) shall be named as the holder of such Regulatory Approvals in the Territory. Xxxx shall reasonably cooperate with Xx Xxxx, at Ji Xing’s expense, to enable Ji Xing (or an Affiliate or a sublicensee of Ji Xing) to acquire and hold any or all such Regulatory Approvals and Regulatory Materials in the Territory, provided, however, that if Applicable Laws in the Territory or any Region thereof do not allow Ji Xing (or an Affiliate or a permitted sublicensee of Ji Xing) to hold Regulatory Approvals or Regulatory Materials for the Products in the Field in the Territory or in a particular Region, then [***].

5.3 Regulatory Materials. Xx Xxxx shall provide Xxxx with drafts of all material Regulatory Materials a reasonable time (to the extent reasonably practicable, no less than [***] prior to submission for review and comment, and shall consider in good faith reasonable comments received from Xxxx no later than [***] prior to submission. In addition, Xx Xxxx shall notify Xxxx of any material Regulatory Materials submitted to or received from any Regulatory Authority in the Territory and shall provide Xxxx with copies thereof within [***] after submission or receipt, and shall notify Xxxx of any other material communication with any Regulatory Authority in the Territory within [***] after such communication. Upon Xx Xxxx’s request and at Xx Xxxx’s cost, Xxxx shall assist Xx Xxxx in addressing any additional requirements requested by any Regulatory Authority in the Territory within a reasonable time (depending on the events), including providing existing supplementary data or documentation.

5.4 Regulatory Meetings. Xx Xxxx shall provide Xxxx with reasonable (to the extent reasonably practicable, no less than [***] advance notice of any meeting or discussion with any Regulatory Authority in the Territory related to the Products. Xx Xxxx shall lead such meeting or discussion; provided, however, that if permissible under Applicable Laws and permitted by the Regulatory Authority, Xxxx or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If Xxxx elects not to attend such meeting or discussion, Xx Xxxx shall promptly provide Xxxx with a written English summary of such meeting or discussion.

5.5 Right of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Materials pertaining to the Products submitted by or on behalf of such Party. Xx Xxxx may use such right of reference to Xxxx’x Regulatory Materials for the purpose of obtaining and maintaining Regulatory Approval of the Products in the Field in the Territory. Xxxx may use such right of reference to Xx Xxxx’s Regulatory Materials for the purpose of obtaining and maintaining Regulatory Approval of the Products outside the Territory.

5.6 Adverse Events Reporting; Quality. Promptly following the Effective Date, but in any event no later than [***], the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the pharmacovigilance procedures for the Parties with respect to the Products, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws. Xxxx shall establish and maintain the global safety database for the Products. Each Party shall hold the primary responsibility for reporting quality complaints, adverse events and safety data related to the Products in its territory to such database and to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities in its territory related to the Products, in each case at its own cost and to the extent required by the Applicable Laws. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.

5.7 Regulatory Audits and Inspection. Xx Xxxx shall promptly notify Xxxx of any audit or inspection of Xx Xxxx, its Affiliates, sublicensees or subcontractors by any Regulatory Authority relating to the Product. Xxxx shall have the right, but not the obligation (unless required or prohibited by Applicable Laws or by the Regulatory Authority), to be present at any such audit or inspection. Xx Xxxx shall also permit the Regulatory Authorities outside the Territory to conduct audits and inspections of Ji Xing, its Affiliates, sublicensees or subcontractors relating to the Products, and shall [***].

5.8 No Harmful Actions. If Xxxx believes that Xx Xxxx is taking or intends to take any action with respect to any Product that could have a material adverse impact on such Product outside the Territory, Xxxx shall have the right to bring the matter to the attention of the JDC, and the Parties shall promptly meet to discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree, (a) Ji Xing shall not communicate with any Regulatory Authority outside the Territory regarding any Product, unless so ordered by such Regulatory Authority, in which case Xx Xxxx shall immediately notify Xxxx of such order; and (b) Ji Xing shall not submit any Regulatory Materials or seek Regulatory Approvals for any Product outside the Territory.

5.9 Remedial Actions. Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or 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. Xx Xxxx shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action. The cost and expenses of any Remedial Action in the Territory shall be borne solely by Xx Xxxx, provided that [***]. Ji Xing shall, and shall ensure that its Affiliates and sublicensees shall, maintain adequate records to permit Xx Xxxx to trace the distribution, sale and use of the Product in the Territory.

ARTICLE 6

MANUFACTURE AND SUPPLY

6.1 Xx Xxxx’s Manufacturing Rights. Subject to the remaining sections of this Article 6, Xx Xxxx may, [***].

6.2 Manufacture Technology Transfer. At Xx Xxxx’s request, the Parties shall agree on a manufacturing technology transfer plan which [***].

6.3 Xx Xxxx’s Third Party Manufacturer. Prior to engaging any Third Party to Manufacture or otherwise supply any Compound or Product in the Territory for or on behalf of Xx Xxxx (including any CMO), Xx Xxxx shall [***]. Any such Third Party manufacturer of Compounds or Products engaged by Xx Xxxx shall [***]. If requested by Xxxx, Xx Xxxx shall [***]. Without limiting the foregoing, [***].

6.4 Xxxx’x Clinical Supply Obligations. Notwithstanding Xx Xxxx’s rights to Manufacture the Compounds and the Products, the Parties shall [***], pursuant to which [***].

6.5 Xxxx’x Commercial Supply Obligations. Notwithstanding Xx Xxxx’s rights to Manufacture the Compounds and the Products, [***], pursuant to which [***]. The commercial supply price shall be [***].

6.6 Audit by Xx Xxxx. Xxxx shall (and shall ensure its Affiliates and shall use Commercially Reasonable Efforts to request that its CMOs) keep complete and accurate records in accordance with GAAP and in sufficient detail relating to the Manufacture of the Compound and Products supplied to Ji Xing [***]. Upon no less than [***] prior notice, Xx Xxxx shall have the right to have an nationally recognized independent certified public accountant, selected by Xx Xxxx and reasonably acceptable to Xxxx to inspect such records in the possession and Control of Xxxx for the purpose of determining the

accuracy of the Manufacturing Cost due within the prior [***] period, provided that all such information and materials reviewed in connection with such audit and the results thereof shall be deemed and treated as the Confidential Information of Xxxx. Such audit may not be conducted more than [***] unless [***], and shall take place at the location(s) where such records, materials, documents are maintained, as available, upon reasonable prior written notice, during regular business hours, and under obligations of confidentiality. If it is determined that any amounts were overpaid or underpaid during such period, Xxxx shall pay Ji Xing such overpaid amounts or Ji Xing shall pay Xxxx the underpaid amounts within [***] of the date the independent certified public accountant’s written report. The fees charged by such independent certified public accountant shall be paid by Xx Xxxx, unless it is determined that any overpaid amounts exceed [***] of the total amount payable by Xx Xxxx to Xxxx for the period then being audited, in which case Xxxx shall be responsible for the reasonable fees charged by such independent certified public accountant for the audit identifying such overpayment.

ARTICLE 7

COMMERCIALIZATION

7.1 General. Subject to the terms and conditions of this Agreement, Xx Xxxx shall, either by itself or through its Affiliates, sublicensees or Third Party contractor(s), be solely responsible for the Commercialization of the Products in the Field in the Territory, at Xx Xxxx’s own cost and expense, including developing and executing a commercial launch plan, product marketing and promotion, marketing access and pricing strategy, negotiating with applicable Governmental Authorities regarding the price and reimbursement mechanisms, booking sales, product distribution, providing customer support (including handling medical queries), and performing other related functions, subject to the terms of this Agreement.

7.2 Commercialization Diligence. Subject to the receipt of the applicable Regulatory Approval, Xx Xxxx shall use Commercially Reasonable Efforts to Commercialize the Product in the Field within the Territory, provided that, under this Section 7.2, if, at any time during the Term, [***], then [***], provided, that, [***].

7.3 Coordination of Commercialization Activities. The Parties recognize that they may benefit from the coordination of certain activities in support of the Commercialization of the Products across their territories. As such, the Parties may agree to coordinate such activities where appropriate, including scientific and medical communication and product positioning. If the Parties agree to jointly conduct any specific Commercialization activities for the benefit of any Product in both Parties’ territories, the Parties shall negotiate and agree on the details of such activities, including allocation of responsibilities, budget and cost sharing.

7.4 Marketing Materials. Upon Xx Xxxx’s reasonable request, Xxxx shall provide Xx Xxxx with copies of Marketing Materials for use by Xx Xxxx solely as permitted herein. Subject to the terms and conditions of this Agreement, Xxxx shall and hereby grants Ji Xing the rights and licenses to use, display, and distribute such Marketing Materials solely in connection with the Commercialization of the Products in the Field in the Territory and in compliance with all other terms and conditions set forth herein. Xx Xxxx shall have the right to, translate, modify and create derivatives and/or variations of the Marketing Materials provided that Xx Xxxx shall provide Xxxx with an opportunity to comment at least [***] before its intended use of such modified Marketing Materials and incorporate any reasonable comments of Xxxx where reasonably practicable; further provided that such actions shall be at Ji Xing’s cost and expense, and that such modifications, derivatives or variations shall be consistent with all the factual statements in the Marketing Materials provided by Xxxx, and further provided that Xx Xxxx shall be liable for its use of any such Marketing Materials subject to representations and warranties made by Xxxx under Section 11.2 and Xxxx’x indemnification obligation under Section 12.2. Ji Xing shall Commercialize the Products, including conducting marketing and advertisement activities, in accordance with Applicable Laws.

7.5 Commercialization Reports. Xx Xxxx shall keep Xxxx reasonably informed of its, its Affiliates’ and sublicensees’ Commercialization activities with respect to the Product. Without limiting the foregoing, Xx Xxxx shall provide Xxxx with a Commercialization report annually regarding the Commercialization activities with respect to the Product in the Territory. Each Commercialization report shall summarize Ji Xing’s, its Affiliates’ and sublicensees’ significant Commercialization activities with respect to the Product in the Territory, covering subject matter at a level of detail reasonably required by Xxxx and sufficient to enable Xxxx to determine Xx Xxxx’s compliance with its diligence obligations pursuant to Section 7.2. In addition, Xx Xxxx shall make available to Xxxx such additional information about its Commercialization activities as may be reasonably requested by Xxxx from time to time.

ARTICLE 8

PAYMENTS AND MILESTONES

8.1 Upfront Payment. In partial consideration of the License, Xx Xxxx shall pay to Xxxx a one-time, non-refundable and non-creditable upfront payment of fifteen million Dollars ($15,000,000), which shall be paid [***].

8.2 Equity Investment. [***] following the execution of this Agreement, Xxxx, [***], [***] and [***], shall enter into definitive documents pursuant to which [***], [***] and [***] will purchase shares of preferred stock issued by Xxxx for an aggregate purchase price of Ten Million Dollars ($10,000,000) at a price per share price based on a fully diluted pre-money valuation of [***].

8.3 Development Milestones Payments.

(a) Milestone Events. Subject to the remainder of this Section 8.3, Xx Xxxx shall pay to Xxxx the following one-time, non-refundable and non-creditable Development milestone payments set forth in the table below upon the first achievement of the corresponding milestone event:


Development Milestones for Products
Development Milestone Event	Payment
[***]		[***]
[***]		[***]
[***]		[***]

Total Development Milestone Payments	$	15,000,000

(b) Milestone Conditions. Each milestone payment set forth above shall be due and payable only once, regardless of how many times such milestone event is achieved or the number of Products that achieves such milestone event. The aggregate milestone payments under this Section 8.3 shall not exceed fifteen million Dollars ($15,000,000).

(c) Notice and Payment. For milestones set forth above to be achieved [***], [***] shall notify [***] in writing within [***] after the first achievement of such milestone. For milestones set forth above to be achieved [***], [***] shall notify [***] in writing within [***] after the first achievement of such milestone; provided, however, that in each case, failure to notify a Party shall be without prejudice to Xx Xxxx’s obligation to make the corresponding milestone payment. Xxxx shall invoice Ji Xing for the corresponding milestone payments promptly after it becomes aware of the achievement of such milestone, and Xx Xxxx shall make the corresponding milestone payment to Xxxx within [***] after receiving a corresponding invoice from Xxxx.

8.4 Sales Milestone Payments.

(a) Milestone Events. Subject to the remainder of this Section 8.4, Xx Xxxx shall pay to Xxxx the following one-time, non-refundable and non-creditable sales-based milestone payments set forth in the table below when the aggregated annual Net Sales of a Product in the Territory (i.e.,

including total sales across all Regions) first reach the corresponding threshold value indicated below.


Aggregate annual Net Sales of a Product in the Territory Exceed	Payment
[***]		[***]
[***]		[***]
[***]		[***]
[***]		[***]

Total Sales Milestone Payments	$	80,000,000

(b) Milestone Conditions. Each sales milestone payment set forth above shall be due and payable only once, regardless of how many times such milestone event is achieved and/or the number of Products that achieves such milestone event. The aggregate milestone payments under this Section 8.4 shall not exceed eighty million Dollars ($80,000,000). For clarity, the sales milestone payments in this Section 8.4 are additive, such that if more than one sales milestone set forth above is achieved in the same time period, then the milestone payments for all such sales milestones shall be payable.

(c) Notice and Payment. As part of the royalty report in Section 8.5(d), Xx Xxxx shall provide written notice to Xxxx if the aggregated annual Net Sales of a Product in the Territory (i.e., including total sales across all Regions) first reaches any threshold value set forth in Section 8.4(a) above during the time period to which such report pertains. Promptly following the delivery of the applicable quarterly report stating a sales milestone has been achieved, Xxxx shall invoice Ji Xing for the corresponding milestone payments, and Ji Xing shall pay to Xxxx the corresponding milestone payments within [***] after Xx Xxxx receives such invoice.

8.5 Royalty Payments.

(a) Royalty Rates. Subject to the remainder of this Section 8.5, Xx Xxxx shall make quarterly royalty payments to Xxxx on the Net Sales of the Products sold in the Territory, as calculated by multiplying the applicable royalty rate set forth in the table below by the corresponding amount of

incremental, aggregated annual Net Sales of all Product sold in the Territory (i.e., including total sales across all Regions) in the applicable Calendar Year.


For that portion of annual aggregate Net Sales of a Product in the Territory			Royalty Rate
1)	less than or equal to	[***]	[***]
2)	greater than but less than or equal to	[*] [*]	[***]
3)	greater than but less than or equal to	[*] [*]	[***]
4)	greater than	[***]	[***]

(b) Royalty Term. Xx Xxxx’s obligation to pay royalties pursuant to this Section 8.5 shall, on a Product-by-Product and Region-by-Region basis, commence upon the First Commercial Sale of such Product, and continue until the latest of (i) [***]; (ii) [***]; and (iii) [***] (the “Royalty Term”).

(i) If a Product is generating Net Sales in a Region in a Calendar Quarter during the applicable Royalty Term at a time when there is no Valid Claim of any Licensed Patent that Covers such Product (in the then current form) in such Region, then, subject to Section 8.5(c)(iv), the royalty rate otherwise applicable to the Net Sales of such Product in such Region in such Calendar Quarter shall be reduced by [***].

(ii) If a Product is generating Net Sales in a Region in a Calendar Quarter during the applicable Royalty Term at a time when one or more Generic Product(s) with respect to such Product is being sold in such Region, then the royalty rate applicable to Net Sales of such Product in such Region in such Calendar Quarter shall be reduced as follows:

(1) [***]; and

(2) [***];

Market share data shall be based on data reported by a well-known reporting service reasonably agreed by the Parties (e.g., IMS International).

(iii) If, on a Product-by-Product and Region-by-Region basis, Xx Xxxx reasonably determines, based on advice of its outside patent counsel, it is necessary for Xx Xxxx to obtain a license from any Third Party under Patent Controlled by such Third Party in order to Manufacture or Commercialize such Product in the Field in the Territory, and does obtain such a license, Xx Xxxx shall have the right to deduct [***] of the amounts paid by Xx Xxxx as royalties in respect of such license to such Third Party in a Calendar Quarter from royalties otherwise due and payable by Xx Xxxx to Xxxx

under this Agreement in such Calendar Quarter, subject to Section 8.5(c)(iv); provided that if Parties cannot agree on whether such Third Party license is necessary, then the Parties shall refer such matter for resolution to an independent patent attorney mutually agreed upon by the Parties and such patent attorney’s decision on the matter shall be binding upon the Parties (and, for clarity, such matter shall not be subject to the dispute resolution procedures set forth in Article 14); further provided that if such Third Party license is found unnecessary for Ji Xing to Manufacture or Commercialize the Product in the Territory, the royalty reduction mechanism described in this Section 8.5(c)(iii) shall not apply with respect to such Third Party license.

(iv) Notwithstanding the foregoing, in no event shall the operation of Section 8.5(c)(i) through Section 8.5(c)(iii), individually or in combination, reduce the royalties paid to Xxxx with respect to the Net Sales of any Product in any Region in the Territory in any Calendar Quarter to less than [***] of the amount that would otherwise have been due pursuant to Section 8.5(a) with respect to such Net Sales.

(d) Royalty Report and Payment. Within [***] after the end of each Calendar Quarter, commencing with the first Calendar Quarter in which there is any Net Sale of the Product anywhere in the Territory, Ji Xing shall provide Xxxx with a report that contains the following information for the applicable Calendar Quarter, on a Product-by-Product and Region-by-Region basis: (i) [***], (ii) [***], (iii) a calculation of the royalty payment due on such sales in Dollars, including the exchange rate and any reduction under Section 8.5(c), and (iv) [***]. Promptly following the delivery of the applicable quarterly report, Xxxx shall invoice Xx Xxxx for the royalties due to Xxxx with respect to Net Sales for such Calendar Quarter and Ji Xing shall pay such amounts to Xxxx within [***] following Xx Xxxx’s receipt of such invoice.

8.6 Sublicensing Payment

(a) Subject to remainder of this Section 8.6, in the event that Xx Xxxx has entered into a Payable Sublicense, Ji Xing shall make sublicensing payments to Xxxx, as calculated by multiplying the applicable sublicensing income share percentage set forth in the table below by the

corresponding Sublicensing Income received by Xx Xxxx from such Payable Sublicenses.


Stage of Development of a Product at the time of Xx Xxxx’s receipt of Sublicensing Income		Applicable Sublicensing Income Share Percentage (%) Due to Xxxx
[***]		[***]
[***]		[***]
[***]		[***]
[***]		[***]

(b) Sublicensing Payment Report and Payment. Xx Xxxx shall notify Xxxx in writing within [***] after the receipt of any Sublicensing Income received and the amount of Xxxx’x share of such Sublicensing Income. Xxxx shall invoice Ji Xing for its share of the corresponding Sublicensing Income promptly after it receives Xx Xxxx’s notice, and Ji Xing shall make the corresponding Sublicensing Income share payment to Xxxx within [***] after receiving a corresponding invoice from Xxxx.

8.7 Currency; Exchange Rate. All payments to be made by Xx Xxxx to Xxxx under this Agreement shall be made in Dollars by bank wire transfer in immediately available funds to a bank account designated by written notice from Xxxx. The rate of exchange to be used in computing the amount of currency equivalent in Dollars shall be made at the average of the closing exchange rates reported in The Wall Street Journal (U.S., Eastern Edition) for the first, middle and last Business Days of the applicable reporting period for the payment due.

8.8 Late Payments. If either Party does not receive payment of any sum due to it on or before the due date therefor, simple interest shall thereafter accrue on the sum due to such Party from the due date until the date of payment at a per-annum rate of [***], or the maximum rate allowable by Applicable Laws, whichever is less.

8.9 Financial Records and Audits. Ji Xing shall (and shall ensure that its Affiliates and use Commercially Reasonable Efforts to request sublicensees) maintain complete and accurate records in accordance with GAAP and in sufficient detail to permit Xxxx to confirm the accuracy of Net Sales reported by Xx Xxxx and amounts payable under this Agreement. Upon no less than [***] prior notice, such records shall be open for examination, during regular business hours, for a period of [***] from the creation of individual records, and not more often than [***], by an independent certified public accountant selected by Xxxx and reasonably acceptable to Xx Xxxx, for the sole purpose of verifying for Xxxx the accuracy of the Net Sales and royalty reports provided by Xx Xxxx under this Agreement. Xxxx shall bear the cost of such audit unless such audit reveals an underpayment by Xx Xxxx of more than [***] of the amount actually due for the time period being audited, in which case Xx Xxxx shall reimburse Xxxx for the costs of such audit. Xx Xxxx shall pay to Xxxx any underpayment discovered by such audit within [***] after the accountant’s report, plus interest (as set forth in Section 8.8) from the original due date. [***].

8.10 Taxes. [***]. Subject to the foregoing, each Party shall be solely responsible for the payment of the Taxes imposed on its share of income arising from its activities or receipt of payments under this Agreement other than such payment set forth in this Section 8, which means that in the event any Tax based on income to Xxxx is required to be withheld and deducted from payments by Xx Xxxx pursuant to this Agreement under Applicable Laws, Xx Xxxx will make such deduction and withholding and will pay the remainder to Xxxx, any amounts so withheld and deducted will be remitted by Xx Xxxx on a timely basis to the appropriate Governmental Authority, and Xx Xxxx will be deemed to have fulfilled all of its payment obligations to Xxxx with respect to such payments. Official receipts of payment of any withholding tax shall be secured and sent to Xxxx as evidence of such payment. Xxxx and Xx Xxxx agree to reasonably assist the other Party in claiming exemption from Tax deductions or withholdings under double taxation or similar agreements or treaties from time to time in force and in minimizing the amount required to be so withheld or deducted.

ARTICLE 9

INTELLECTUAL PROPERTY

9.1 Ownership of Inventions.

(a) Ownership.

(i) Inventions. The ownership of Inventions, including all rights to priority and rights to file patent applications and/or register designs, shall be determined based on the principles of inventorship in accordance with U.S. patent laws. [***]. Each Party will own an undivided half interest in the Joint Inventions, without a duty of accounting or an obligation to seek consent from the other Party for the transfer, assignment, exploitation or license of the Joint Inventions (subject to the licenses granted to the other Party under this Agreement).

(ii) Ji Xing Improvements. Subject to the license and rights granted to Xxxx pursuant to Section 2.4, Xx Xxxx shall solely own all Ji Xing Improvements, including all rights to priority and rights to file patent applications and/or register designs.

(b) Assignment Obligation. Each Party shall cause all Persons who perform activities for such Party under this Agreement to be under an obligation to assign their rights, including all rights to priority and rights to file patent applications and/or register designs, in any Patent and Know-How, whether or not patentable, resulting therefrom to such Party to effectuate the terms and conditions set forth in Section 9.1(a).

(c) Disclosure of Inventions. Each Party will promptly disclose to the other Party all Inventions, including all invention disclosure or other similar documents submitted to such Party by its or its Affiliates’ employees, agents, or independent contractors relating to such Inventions, and will also promptly respond to reasonable requests from the other Party for additional information relating to such Inventions.

9.2 Patent Prosecution.

(a) As between the Parties, [***].

(b) [***].

(d) Each Party shall provide the other Party all reasonable assistance and cooperation in the patent prosecution efforts under this Section 9.2, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution.

9.3 Patent Enforcement.

(a) Each Party shall promptly notify the other Party if it becomes aware of any alleged or threatened infringement by a Third Party of any of the Licensed Patents in the Territory, and any related declaratory judgment, opposition, or similar action alleging the invalidity, unenforceability or non-infringement of any of the Licensed Patents in the Territory.

(b) As between the Parties, Xx Xxxx shall have the first right (but not the obligation) to bring and control any legal action in connection with any infringement of the Licensed Patents in the Territory with respect the [***] in the Field in the Territory (a “Product Infringement”), at Xx Xxxx’s own expense as it reasonably determines appropriate. If Xx Xxxx does not bring such legal action within [***] after the notice provided pursuant to Section 9.3(a), Xxxx shall have the right (but not the obligation) to bring and control any legal action in connection with such Product Infringement in the Territory, at Xxxx’x own expense as it reasonably determines appropriate.

(c) At the request and expense of the Party bringing an action under Section 9.3(b) above, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required by Applicable Laws to pursue such action. In connection with any such enforcement action, the enforcing Party shall keep the other Party reasonably informed on the status of such action and shall not enter into any settlement admitting the invalidity or non-infringement of, or

otherwise impairing the other Party’s rights in the Licensed Patents without the prior written consent of the other Party. The non-enforcing Party shall be entitled to separate representation in such enforcement action by counsel of its own choice and at its own expense.

(d) Any recoveries resulting from enforcement action relating to a claim of Product Infringement in the Territory shall be first applied against payment of each Party’s costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses shall be retained by the enforcing Party, provided that if Xx Xxxx is the enforcing Party, then such excess recoveries shall be [***].

(e) Xxxx shall have the exclusive right to bring and control any legal action to enforce the Licensed Patents against any infringement that is not a Product Infringement, at Xxxx’x own expense and as it reasonably determines appropriate, and shall have the right to retain all recoveries.

9.4 Infringement of Third Party Rights.

(a) Each Party shall notify the other Party of any allegations it receives from a Third Party that the Development, Manufacture or Commercialization of any Product in the Field in the Territory under this Agreement infringes the intellectual property rights of such Third Party. Such notice shall be provided promptly, but in no event after more than [***] following receipt of such allegations. Such notice shall include a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Thereafter, the Parties shall promptly meet to consider the claim or assertion and the appropriate course of action and may, if appropriate, agree on and enter into a “common interest agreement” wherein the Parties agree to their shared, mutual interest in the outcome of such potential dispute. Each Party shall assert and not waive the joint defense privilege with respect to all communications between the Parties.

(b) [***]. Xx Xxxx shall keep Xxxx informed on the status of such defense action, and Xxxx shall have the right, but not the obligation, to participate and be separately represented in such defense action at its sole option and at its own expense. Xxxx shall also have the right to control the defense of any infringement claim brought against Xxxx, at Xxxx’x own cost and expense, provided that [***].

9.5 Patent Marking. Ji Xing shall mark all Products sold in the Territory in accordance with the applicable patent marking laws, and shall require all of its Affiliates and sublicensees to do the same. To the extent permitted by Applicable Laws, Ji Xing shall indicate on the product packaging, advertisement and promotional materials that the Products are in-licensed from Xxxx.

9.6 Trademarks.

(a) Subject to Sections 9.6(b) and 9.6(c) below, Ji Xing shall have the right to brand the Products sold in the Territory using any trademarks and trade names it determines appropriate for the Product, which may vary by Region or within a Region (the “Product Marks”); provided that Ji Xing shall not select any mark or China-approved drug name that is confusingly similar to any Xxxx Trademarks as a Product Mark. Xx Xxxx shall own all rights in the Product Marks in the Territory and shall register and maintain the Product Marks in the Territory that it determines reasonably necessary, at Xx Xxxx’s own cost and expense.

(b) Xx Xxxx acknowledges that Xxxx may develop a global branding strategy for the Products and adopt the key distinctive colors, logos, images, symbols, and trademarks to be used in connection with the Commercialization of the Products throughout the world (collectively and including any Chinese language versions thereof, the “Xxxx Trademarks”). Xxxx shall own all rights in the Xxxx Trademarks and shall have the sole right (but not the obligation) to register, maintain and enforce the Xxxx Trademarks in any country in the world as it determines appropriate, at Xxxx’x own cost and expense.

(c) Subject to the terms and conditions of this Agreement and for no additional considerations, Xxxx hereby grants to Xx Xxxx a non-transferable, limited, non-exclusive license to use the Xxxx Trademarks solely in connection with the Commercialization of the Product in the Field in the Territory during the Term of this Agreement, and if Ji Xing elects to Commercialize the Product in the Territory using the Xxxx Trademarks, Xx Xxxx shall do so in a manner consistent with Xxxx’x global branding strategy for the Product. Other than as permitted under this Agreement, Xx Xxxx will not adopt, use, or register any Xxxx Trademarks or any other trademarks, service marks, logos, or name that is identical to or confusingly similar with any trademarks of Xxxx. At Xxxx’x request, Xx Xxxx will furnish to Xxxx at Xx Xxxx’s expense sample uses of Xxxx Trademarks for review by Xxxx. It is understood and agreed that Xxxx shall retain all right, title and interest in and to Xxxx Trademarks. Nothing contained in this Agreement will give Xx Xxxx any interest in Xxxx Trademarks. Xx Xxxx agrees that it will not, at any time during or after the Term of this Agreement, assert or claim any interest in or do anything which may adversely affect the validity or enforceability of any Xxxx Trademarks. Xx Xxxx’s use of Xxxx Trademarks will not tarnish, blur, or dilute the quality associated with Xxxx Trademark or the associated goodwill. Any benefits (including, without limitation, goodwill) accruing from Xx Xxxx’s use of Xxxx Trademarks will automatically vest in Xxxx.

ARTICLE 10

CONFIDENTIALITY

10.1 Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that, for the Term and for a period of [***] thereafter, it shall keep confidential and shall not publish or otherwise disclose and shall not use for

any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any Confidential Information of the other Party pursuant to this Agreement.

10.2 Exceptions. The foregoing confidentiality and non-use obligations shall not apply to any portion of the Confidential Information that the receiving Party can demonstrate by competent written proof:

(a) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

(d) is subsequently disclosed to the receiving Party by a Third Party who has a legal right to make such disclosure; or

(e) is subsequently independently discovered or developed by the receiving Party without the aid, application, or use of the disclosing Party’s Confidential Information, as evidenced by a contemporaneous writing.

10.3 Authorized Disclosure. Notwithstanding the obligations set forth in Section 10.1, a Party may disclose the other Party’s Confidential Information and the terms of this Agreement to the extent:

(a) such disclosure is reasonably necessary (i) for the filing or prosecution of Patents as contemplated by this Agreement; (ii) in connection with regulatory filings for the Product; or (iii) for the prosecuting or defending litigation as contemplated by this Agreement;

(b) such disclosure is reasonably necessary: (i) to such Party’s directors, attorneys, independent accountants or financial advisors for the sole purpose of enabling such directors, attorneys, independent accountants or financial advisors to provide advice to the receiving Party, provided that in each such case on the condition that such directors, attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations consistent with those contained in this Agreement; or (ii) to actual or potential investors, acquirers, licensors, licensees, collaborators or other business or financial partners (including royalty financing partners) solely for the purpose of evaluating or carrying out an actual

or potential investment, acquisition, license, collaboration, financing or other business transaction; provided that in each such case on the condition that such disclosees are bound by confidentiality and non-use obligations consistent with those contained in this Agreement and provided further that any breach of the confidentiality and non-use provisions of this Article 10 by any such disclosee shall be deemed a breach of this Article 10 by the receiving Party; or

(c) such disclosure is required by judicial or administrative process, provided that in such event such Party shall promptly inform the other Party of such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article 10, and the Party disclosing Confidential Information pursuant to law or court order shall take all steps reasonably necessary, including seeking of confidential treatment or a protective order, to ensure the continued confidential treatment of such Confidential Information.

10.4 Scientific Publication. Except to the extent required by Applicable Laws, [***].

10.5 Publicity.

(a) Parties may jointly issue, a press release announcing this Agreement after the Effective Date. Subject to the rest of this Section 10.5, no disclosure of the terms of this Agreement may be made by either Party, and no Party shall use the name, trademark, trade name or logo of the other Party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required by Applicable Laws. Subject to this Section 10.5(a) and Section 10.5(b), if either Party desires to issue a press release or other public statement announcing this Agreement, disclosing information relating to this Agreement or the transactions contemplated hereby or the terms hereof, where such press release or public statement discloses new or different content from any joint press release or other previously agreed public disclosure, or discloses any previously disclosed information in a materially different context, the issuing Party will provide the other Party with a copy of the proposed press release or public statement for a reasonable period of time (at least [***] prior to the proposed release or publication) within which the reviewing Party may provide any comments on such proposed press release or public statement. Subject to this Section 10.5(a) and Section 10.5(b), if the reviewing Party provides any comments, the Parties shall consult with one another on such proposed press release or public statement and work in good faith to prepare a mutually acceptable press release or public statement, provided that nothing in this Section 10.5(a) shall prohibit a Party from making a disclosure as it determines, based on advice of counsel, is reasonably necessary to comply with Applicable Laws or for appropriate market disclosure. Each Party shall be free to disclose or publicize, without the other Party’s prior written consent, the existence of this Agreement, the identity of the other Party, those terms of this Agreement or information related

to this Agreement that have already been publicly disclosed in accordance herewith provided that such information continues as of such time to be accurate, and is disclosed in substantially the same context as the previously approved disclosure.

(b) A Party may disclose this Agreement and its terms in securities filings with the U.S. Securities Exchange Commission (or equivalent foreign agency) (“SEC”) to the extent required by Applicable Laws after complying with the procedure set forth in this Section 10.5. In such event, the Party seeking such disclosure shall prepare a draft confidential treatment request and proposed redacted version of this Agreement to request confidential treatment for this Agreement, and the other Party agrees to promptly (and in any event, no less than [***] after receipt of such confidential treatment request and proposed redactions) give its input in a reasonable manner in order to allow the Party seeking disclosure to file its request within the time lines prescribed by applicable SEC regulations. The Party seeking such disclosure shall exercise commercially reasonable efforts to obtain confidential treatment of this Agreement from the SEC as represented by the redacted version reviewed by the other Party.

(c) Each Party acknowledges that the other Party may be legally required to make public disclosures (including in filings with the SEC or other agency) of certain material developments or material information generated under this Agreement and agrees that each Party may make such disclosures as required by Applicable Laws, provided that the Party seeking such disclosure first provides the other Party a copy of the proposed disclosure, and provided further that (except to the extent that the Party seeking disclosure is required to disclose such information to comply with Applicable Laws) if the other Party demonstrates to the reasonable satisfaction of the Party seeking disclosure, within [***] of such Party’s providing the copy, that the public disclosure of previously undisclosed information shall materially adversely affect the Development and/or Commercialization of a Product being Developed and/or Commercialized, the Party seeking disclosure shall remove from the disclosure such specific previously undisclosed information as the other Party shall reasonably request to be removed.

10.6 Prior CDA. This Agreement supersedes the Mutual Confidential Disclosure Agreement between the Parties [***] (the “Prior CDA”) with respect to information disclosed thereunder. All information exchanged between the Parties under the Prior CDA shall be deemed Confidential Information of the disclosing Party and shall be subject to the terms of this Article 10.

10.7 Equitable Relief. Each Party acknowledges that a breach of this Article 10 may not reasonably or adequately be compensated by damages in an action at law and that such a breach may cause the other Party irreparable injury and damage. By reason thereof, each Party agrees that the other Party shall be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to preliminary and permanent injunctive and other equitable relief to prevent or curtail any breach of the obligations relating to Confidential Information set forth herein.

10.8 Attorney-Client Privilege. Neither Party is waiving, nor shall be deemed to have waived or diminished, any of its attorney work product protections, attorney-client privileges or similar protections and privileges or the like, as a result of disclosing information pursuant to this Agreement, or any of its Confidential Information (including Confidential Information related to pending or threatened litigation) to the other Party, regardless of whether the disclosing Party has asserted, or is or may be entitled to assert, such privileges and protections. The Parties: (a) share a common legal and commercial interest in such disclosure that is subject to such privileges and protections; (b) are or may become joint defendants in proceedings to which the information covered by such protections and privileges relates; (c) intend that such privileges and protections remain intact should either Party become subject to any actual or threatened proceeding to which the disclosing Party’s Confidential Information covered by such protections and privileges relates; and (d) intend that after the Effective Date, both the receiving Party and the disclosing Party shall have the right to assert such protections and privileges.

ARTICLE 11

REPRESENTATIONS AND WARRANTIES

11.1 Representations, Warranties, and Covenants of Each Party. Each Party represents, warrants, and covenants (as applicable) to the other Party that:

(a) it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement;

(b) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder, and this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and similar laws affecting creditors’ rights and remedies generally;

(c) it is not a party to, and shall not enter into during the Term, any agreement that would prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under this Agreement; and

(d) in the course of performing its obligations or exercising its rights under this Agreement, it shall comply in all material respects with all Applicable Laws, including Anti-Corruption Laws and Privacy Laws, and shall not employ or engage any person or entity who has been debarred by

any Regulatory Authority, or, to such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority. Without limiting the generality of the foregoing, the Parties shall comply with all Applicable Laws concerning bribery, money laundering, or corrupt practices or which in any manner prohibit the giving of anything of value to any official, agent, or employee of any government, political party, or public international organization, candidate for public office, health care professional, or to any officer, director, employee, or representative of any other organization specifically including the Anti-Corruption Laws in connection with the activities conducted pursuant to this Agreement.

11.2 Representations, Warranties, and Covenants of Xxxx. Xxxx represents, warrants, and covenants (as applicable) to Xx Xxxx that:

(a) it has the right under the Licensed IP to grant the licenses to Xx Xxxx as purported to be granted under Section 2.1 of this Agreement;

(b) it has not granted, and shall not grant during the Term, any license or other right under the Licensed IP that is inconsistent with the license granted to Xx Xxxx under Section 2.1;

(c) Exhibit B includes all Licensed Patents as of the Effective Date. Xxxx is the sole and exclusive owner of the Licensed Patents. To Xxxx’x knowledge, all Licensed Patents are (i) subsisting and in good standing and (ii) being diligently prosecuted in the respective patent offices in accordance with Applicable Laws, and have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment. To Xxxx’x knowledge, all issued Licensed Patents are valid and enforceable as of the Effective Date;

(d) all Licensed Know-How is free and clear of any material claims, liens, charges or encumbrances;

(e) as of the Effective Date, it has not received any written notice from any Third Party asserting or alleging that the Development of the Products prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party;

(f) as of the Effective Date, there are no pending or, to Xxxx’x knowledge, threatened (in writing), adverse actions, claims, suits or proceedings against Xxxx or any of its Affiliate involving the Licensed IP or the Compound or Product. To Xxxx’x knowledge, no claim or litigation has been brought or threatened by any Person, (i) alleging that the Licensed Patents are invalid or unenforceable, (ii) asserting the misuse, or infringement of any of the Licensed Patents, (iii) challenging Xxxx’x Control of the Licensed Patents or (iv) alleging infringement of any issued Patent or misappropriation of the Know-How used in the Development or Manufacture of the Compounds or Products by or on behalf of Xxxx prior to the Effective Date;

(g) To Xxxx’x knowledge, as of the Effective Date, the Manufacture or Commercialization of the Product in the Field in the Territory contemplated under this Agreement does not infringe any issued Patent in the Territory or misappropriate or otherwise violate any Know-How of any Third Party in the Territory;

(h) as of the Effective Date, it and its Affiliates (and to its knowledge, any Third Party acting under its authority) (i) have complied in all material respects with all Applicable Laws and applicable governmental regulations and industrial standards (including GLP, GCP, and GMP, as applicable) in connection with the Development, Manufacture, storage and disposition of the Compounds and Products (including information and data provided to Regulatory Authorities), and (ii) have not used any employee, consultant or contractor who has been debarred by any Regulatory Authority, or is the subject of a debarment proceeding by any Regulatory Authority in connection therewith;

(i) no Upstream License exists as of the Effective Date;

(j) as of the Effective Date, there is no pending or, to Xxxx’x knowledge, threatened (in writing), adverse actions, claims, suits or proceedings against Xxxx or any of its Affiliate that involve any antitrust, anti-competition, Anti-Corruption Law violations or that may reasonably be expected to adversely affect Xxxx’x ability to perform its obligations under this Agreement.

11.3 Representations, Warranties, and Covenants of Xx Xxxx. Xx Xxxx represents, warrants, and covenants (as applicable) to Xxxx that:

(a) neither Xx Xxxx nor any of its Affiliates is, or has been, debarred or disqualified by any Regulatory Authority nor shall any of them be debarred or disqualified by any Regulatory Authority at any time throughout the Term;

(b) as of the Effective Date, there is no pending or, to Xx Xxxx’s knowledge, threatened (in writing), adverse actions, claims, suits or proceedings against Xx Xxxx or any of its Affiliate that involve any antitrust, anti-competition, Anti-Corruption Law violations or that may reasonably be expected to adversely affect Xx Xxxx’s ability to perform its obligations under this Agreement; and

(c) it has sufficient financial wherewithal to (i) perform all of its obligations pursuant to this Agreement, and (ii) meet all of its obligations that come due in the ordinary course of business.

11.4 Compliance with FCPA. By signing this Agreement, each Party represents, warrants and covenants (as applicable) to the other Party that: (i) it is familiar with the provisions and restrictions contained in the OECD Convention and FCPA, and shall comply with the FCPA in the Development

and Commercialization of the Products under this Agreement; (ii) it shall not, in the course of its duties under this Agreement, offer, promise, give, demand, seek or accept, directly or indirectly, any gift or payment, consideration or benefit in kind to any governments, government officials, political parties or political party officials (or relatives or associates of such officials) (“FCPA Covered Person”) that would or could be construed as an illegal or corrupt practice; (iii) it is not an FCPA Covered Person or affiliated with any FCPA Covered Person; and (iv) it shall immediately notify the other Party of any attempt by any FCPA Covered Person to directly or indirectly solicit, ask for, or attempt to extort anything of value from such Party, its Affiliates or sublicensees, and shall refuse any such solicitation, request or extortionate demand except a facilitating payment as expressly permitted under the FCPA.

(a) Compliance Certificate. From time to time upon request from either Party, the other Party shall submit a compliance certificate in the form reasonably requested by the requesting Party that (i) it fully understands its obligations under this Section 11.4 and any other Applicable Laws mentioned herein or as may come into existence from time to time after the Effective Date; (ii) it has been complying with this Section 11.4 and any other Applicable Laws mentioned herein or as may come into existence from time to time after the Effective Date; and (iii) it shall continue to comply with this Section 11.4 and any other Applicable Laws mentioned herein or as may come into existence from time to time after the Effective Date.

(b) Due Diligence. Each Party shall have the right to visit the offices of the other Party from time to time during the term of this Agreement on an “as reasonably needed” basis (provided such visit shall not occur more than once per Calendar Year unless the Party requesting such visit has cause) and conduct due diligence in relation to such other Party’s business related to performance of its obligations under this Section 11.4 and may do so in the way it deems necessary, appropriate or desirable so as to ensure that the Party being examined complies with this Section 11.4 and any other Applicable Laws in its business operations. Each Party shall make every effort to cooperate fully with the other Party in any such due diligence; and

(c) Audit. In the event that either Party (the “Auditing Party”) has reason to believe that a breach of any obligation of the other Party (the “Audited Party”) under this Section 11.4 has occurred or may occur, the Auditing Party shall have the right to select an independent third party to conduct an audit of the Audited Party and review relevant books and records of the Audited Party, to reasonably satisfy itself that no breach has occurred. Unless otherwise required under Applicable Laws or by order of a competent court or regulatory authority, the Auditing Party shall ensure that the selected independent third party shall keep confidential all audited matters and the results of the audit. The Auditing Party shall not disclose to the U.S. or foreign government, its agencies and/or any other government or non-government party, information relating to a possible violation by the Audited Party of any Applicable Law, including a violation of the FCPA or any other applicable anti-bribery law, unless the Auditing Party is required to do so under Applicable Laws.

11.5 NO OTHER WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED. Xx Xxxx acknowledges and agrees that the Products are the subject of ongoing clinical research and development and that Xxxx cannot assure the safety, usefulness or successful Development or Commercialization of the Product.

ARTICLE 12

INDEMNIFICATION

12.1 Indemnification by Xx Xxxx. Xx Xxxx shall indemnify, defend and hold harmless Xxxx, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “Xxxx Indemnitee(s)”) from and against all losses, liabilities, damages and expenses (including reasonable attorneys’ fees and costs) incurred in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, “Losses”) to the extent arising from:

(a) the Development, Manufacture, and Commercialization of any of the Compounds and/or Products in the Territory by Ji Xing or any of its Affiliates or sublicensees (including product liability claims resulting therefrom);

(b) the gross negligence or willful misconduct by Xx Xxxx, any of its Affiliates, sublicensees or contractors, or any of their respective directors, officers, employees and agents, in performing Xx Xxxx’s obligations or exercising Xx Xxxx’s rights under this Agreement; or

except in each case to the extent such Losses arise out of the negligence, willful misconduct or breach of this Agreement by any Xxxx Indemnitee or arise from, are based on, or result from any activity or occurrence for which Xxxx is obligated to indemnify Ji Xing under Section 12.2.

12.2 Indemnification by Xxxx. Xxxx shall indemnify, defend and hold harmless Xx Xxxx, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “Xx Xxxx Xxxxxxxxxx(s)”) from and against all Losses to the extent arising from:

(a) the Development, Manufacture, and Commercialization of the Compounds and Products outside (and inside, if any) the Territory by Xxxx or any of its Affiliates or Xxxx Licensees (including product liability claims resulting therefrom);

(b) the gross negligence or willful misconduct by Xxxx, any of its Affiliates, Xxxx Licensees or contractors, or any of their respective directors, officers, employees and agents, in performing Xxxx’x obligations or exercising Xxxx’x rights under this Agreement; or

except in each case to the extent such Losses arise out of the negligence, willful misconduct or breach of this Agreement by any Ji Xing Indemnitee or arise from, are based on, or result from any activity or occurrence for which Xx Xxxx is obligated to indemnify Xxxx under Section 12.1.

12.3 Indemnification Procedure. If either Party is seeking indemnification under Sections 12.1 or 12.2 (the “Indemnified Party”), it shall inform the other Party (the “Indemnifying Party”) of the claim giving rise to the obligation to indemnify pursuant to such Section within [***] after receiving notice of the claim (it being understood and agreed, however, that the failure or delay by an Indemnified Party to give such notice of a claim shall not affect the indemnification provided hereunder except to the extent the Indemnifying Party shall have been prejudiced as a result of such failure or delay to give notice). The Indemnifying Party shall have the right to assume the defense of any such claim for which it is obligated to indemnify the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party and the Indemnifying Party’s insurer as the Indemnifying Party may reasonably request, and at the Indemnifying Party’s cost and expense. The Indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim that has been assumed by the Indemnifying Party. Neither Party shall have the obligation to indemnify the other Party in connection with any settlement made without the Indemnifying Party’s written consent, which consent shall not be unreasonably withheld, conditioned, or delayed.

12.4 Mitigation of Loss. Each Indemnified Party shall take and shall procure that its Affiliates take all such reasonable steps and action as are reasonably necessary or as the Indemnifying Party may reasonably require in order to mitigate any claims (or potential losses or damages) under this Article 12. Nothing in this Agreement shall or shall be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it.

12.5 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL (WHICH SHALL BE DEEMED TO INCLUDE, WITHOUT LIMITATION, ALL DAMAGES CONSTITUTING LOSS OF PROFIT, LOSS OF REVENUE AND LOSS OF GOODWILL), INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 12.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 12.1 OR 12.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF SECTION 2.7 OR ARTICLE 10.

12.6 Insurance. Each Party shall procure and maintain insurance with respect to its activities hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times during which any Product is being clinically tested in human subjects or commercially distributed or sold. Each Party shall provide the other Party with evidence of such insurance upon request and shall provide the other Party with written notice at least [***] prior to the cancellation, non-renewal or material changes in such insurance. Such insurance shall not be construed to create a limit of either Party’s liability under this Agreement.

ARTICLE 13

TERM AND TERMINATION

13.1 Term.

(a) The term of this Agreement shall commence upon the Effective Date and continue in full force and effect, on a Product-by-Product and Region-by-Region basis, until the expiration of all Royalty Terms for all Products in all Regions in the Territory, unless earlier terminated as set forth in Section 13.2 below (the “Term”).

(b) Upon expiration (but not early termination) of the Royalty Term with respect to a particular Product in a particular Region, the licenses granted by Xxxx to Ji Xing under Section 2.1 with respect to such Product in such Region shall continue and shall become fully paid-up, royalty-free, perpetual and irrevocable.

13.2 Termination.

(a) Termination by Xx Xxxx for Convenience. At any time, Xx Xxxx may terminate this Agreement in its entirety by providing written notice of termination to Xxxx, which notice includes an effective date of termination at least one hundred eighty (180) days after the date of the notice.

(b) Termination for Material Breach. If either Party materially breaches this Agreement, then the non-breaching Party may terminate this Agreement by delivering notice of such material breach to the other Party, which notice shall (i) expressly reference this Section 13.2(b), (ii) reasonably describe the alleged material breach which is the basis of such termination, and (iii) clearly state the non-breaching Party’s intent to terminate this Agreement if the alleged material breach is not cured within [***] after the alleged breaching Party’s receipt of such notice. If the alleged material breach occurred and is not cured within such [***], this Agreement shall terminate automatically. Notwithstanding the foregoing, (A) if such material breach, by its nature, is curable, but is not reasonably curable within [***], then such cure period shall be extended if the alleged breaching Party provides a written plan for curing such breach to the non-breaching Party and uses Commercially Reasonable Efforts to cure such breach in accordance with such written plan; provided, however, that no such extension shall exceed [***] without the written consent of the non-breaching Party; and (B) if the alleged breaching Party disputes (1) whether it has materially breached this Agreement, (2) whether such material breach is reasonably curable within the applicable cure period, or (3) whether it has cured such material breach within the applicable cure period, in each case provided that the breaching Party notifies the non-breaching Party in writing of any such dispute within [***] after the non-breaching Party’s receipt of the termination notice, such dispute shall be resolved pursuant to Article 14, and this Agreement may not be terminated during the pendency of such dispute resolution procedure. During the pendency of such dispute, the applicable cure period shall be tolled, all the terms of this Agreement shall remain in effect, and the Parties shall continue to perform all of their respective obligations hereunder.

(c) Termination for Insolvency. Each Party shall have the right to terminate this Agreement in its entirety immediately upon written notice to the other Party in the event that (i) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (ii) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within sixty (60) days of its filing, or (iii) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.

(d) Termination for Patent Challenge. Except to the extent the following is unenforceable under the laws of a particular jurisdiction, Xxxx may terminate this Agreement in its entirety with sixty (60) days’ prior written notice to Xx Xxxx if Xx Xxxx or its Affiliates or sublicensees, individually or in association with any other person or entity, commences a legal action challenging the validity, enforceability or scope of any Licensed Patent. Notwithstanding the foregoing, Xxxx shall not have the right to terminate this Agreement under this Section 13.2(d) if (i) such legal action was brought by a Third Party sublicensee and Xx Xxxx has terminated such sublicense, (ii) such legal action is based solely on the scope of a Licensed Patent

or whether a claim therein qualifies as a Valid Claim or Covers the Product (in the then-current form) and was made in defense of a breach claim first brought by Xxxx against Xx Xxxx, or an Affiliate or a sublicensee of Xx Xxxx, or (iii) such legal action is dismissed within sixty (60) days of Xxxx’x notice to Xx Xxxx under this Section 13.2(d) and not thereafter continued.

13.3 Effect of Termination. Upon any termination of this Agreement:

(a) License to Xx Xxxx. All licenses and other rights granted by Xxxx to Xx Xxxx under the Licensed IP shall terminate, and all sublicenses granted by Xx Xxxx shall also terminate.

(b) Regulatory Materials. Ji Xing shall (and shall cause its Affiliates and sublicensees to), as instructed by Xxxx, either (i) if permitted by Applicable Laws, promptly transfer and assign to Xxxx or its designee all Regulatory Materials and Regulatory Approvals for the Products in the Territory, (ii) continue to hold any such Regulatory Materials and Regulatory Approvals for the sole benefit of Xxxx or its designee (in which case, Ji Xing shall appoint Xxxx or its designee as the exclusive distributor (with the right to subcontract and appoint sub-distributors) under such Regulatory Materials and Regulatory Approvals for the Products in the Territory, and also as its agent to interact with the applicable Regulatory Authority in the Territory with respect to such Regulatory Materials and Regulatory Approvals), until such time Xxxx or its designee files its own Regulatory Materials and obtains its own Regulatory Approvals for the Products in the Territory; or (iii) terminate or withdraw any such Regulatory Materials and Regulatory Approvals. Upon Xxxx’x request, Xx Xxxx shall also provide Xxxx with reasonable assistance and cooperation regarding any inquiries and correspondence with Regulatory Authorities relating to the Product.

(c) Data. Ji Xing, to the extent permitted by Applicable Laws, shall (and shall cause its Affiliates and sublicensees to) promptly transfer and assign to Xxxx, at no cost to Xxxx, all data generated from the Development of the Product, including all Clinical Trials conducted by or on behalf of Xx Xxxx, its Affiliates and sublicensees, and all pharmacovigilance data (including all adverse event databases) relating to the Products in the Territory.

(d) Inventory. Xx Xxxx shall have the right, for a period of [***] following termination of this Agreement, to sell or otherwise dispose of any Compound or Product in the Territory, on hand at the time of such termination or in the process of Manufacturing. Upon expiration of the [***], Xxxx shall have the right (but not the obligation) to purchase from Ji Xing any or all of the inventory of the Compound or Product then held by Xx Xxxx or its Affiliates or sublicensees (i) at a price equal to [***] or (ii), at a price equal to [***], provided, in each of (i) and (ii), that [***].

(e) Transition Assistance. Ji Xing shall (and shall cause its Affiliates and sublicensees to) reasonably cooperate with Xxxx to facilitate orderly transition of the Development, Manufacture and Commercialization of the Product to Xxxx, including (i) assigning or amending as appropriate, upon request of Xxxx, any agreements or arrangements with Third Party contractor or subcontractors (including distributors) to Develop, Manufacture, promote, distribute, sell or otherwise Commercialize the Products or, to the extent any such Third Party agreement or arrangement is not assignable to Xxxx, reasonably cooperating with Xxxx to arrange to continue to provide such services for a reasonable time after termination; (ii) sublicensing or assigning to Xxxx Xx Xxxx’s rights (to the extent Controlled by Xx Xxxx) under, or amending as appropriate, upon request of Xxxx, any inbound license or sublicense agreements or other arrangements of rights with Third Party owners of, any Patents necessary or reasonably useful for the Development, Manufacture or Commercialization of the Product and/or any Know-How that relates to or otherwise Covers the Development, Manufacture or Commercialization of the Product, or if such agreement or arrangement is not assignable to Xxxx, reasonably cooperating with Xxxx to arrange to continue to receive the benefit of such license(s), sublicense(s) or other rights; (iii) to the extent that Ji Xing or its Affiliate or sublicensee is performing any activities described above in (i), reasonably cooperating with Xxxx to transfer such activities to Xxxx or its designee, and continuing to perform such activities on Xxxx’x behalf for a reasonable time after termination until such transfer is completed; and (iv) providing Xxxx with, at Xxxx’x cost, reasonable quantities of materials used or generated by Xx Xxxx, its Affiliates and sublicensees in the Development and Commercialization of the Products in the Territory, such as clinical brochures and promotional materials, or any chemical or biological materials, that were not received from Xxxx.

(f) Ongoing Clinical Trials. If at the time of such termination, any Clinical Trials for any Product are being conducted by or on behalf of Xx Xxxx, its Affiliates or sublicensees, then, at Xxxx’x election on a trial-by-trial basis and to the extent permissible under Applicable Laws: (i) Xx Xxxx shall (and shall cause its Affiliates and sublicensees to) fully cooperate with Xxxx to transfer the conduct of all such Clinical Trials to Xxxx, and Xxxx shall assume any and all liability and costs for such Clinical Trials after the effective date of such termination; or (ii) Ji Xing shall (and shall cause its Affiliates and sublicensees to), orderly wind down, in compliance with Applicable Laws, the conduct of any such Clinical Trial which is not assumed by Xxxx under clause (i).

(g) Return of Confidential Information. Ji Xing shall (and shall cause its Affiliates and sublicensees to) promptly return or destroy (at Xxxx’x election) all tangible materials comprising, bearing or containing any Confidential Information of Xxxx that are in Xx Xxxx’s or its Affiliates’ or sublicensees’ possession or control, except for retaining one copy for documentation purpose.

(h) Termination Press Releases. Subject to the provisions of Section 10.5, the Parties shall cooperate in good faith to coordinate public disclosure of the termination of this Agreement and the reasons therefor, and neither Party shall, except to the extent required by Applicable Laws, disclose any such information without the prior approval of the other Party. The principles to be observed in such disclosures shall be accuracy, compliance with Applicable Laws and regulatory guidance documents, and reasonable sensitivity to potential negative investor reaction to such news.

(i) Trademarks. Ji Xing shall (and shall cause its Affiliates and sublicensees to) promptly transfer and assign to Xxxx all Product Marks (excluding any such mark that includes, in whole or in part, any corporate name or logos of Ji Xing or its Affiliates or sublicensees).

(j) Transition Costs. Xxxx shall reimburse Ji Xing for the internal and external costs incurred in performing such transition activities or providing such assistance under Sections 13.3(b), 13.3(e), 13.3(f) and 13.3(i), unless this Agreement is terminated by Xxxx in accordance with Section 13.2(b) or Section 13.2(d) or by Xx Xxxx in accordance with Section 13.2(a).

(k) License to Xxxx. The license granted to Xxxx under Section 2.4 shall continue. [***]:

(i) [***] in a Region in the Territory, if [***];

(ii) [***] in a Region in the Territory, if [***]; and

(iii) [***] in a Region in the Territory, if [***].

The definition of “Net Sales” and Section 8.5(d), and Sections 8.7 through 8.9 shall apply mutatis mutandis with respect to the sale of such Product by or on behalf of Xxxx in the Territory.

(l) Rights in Bankruptcy. The Parties acknowledge that this Agreement constitutes an executory contract under Section 365 of the Code for the license of “intellectual property” as defined under Section 101 of the Code and constitutes a license of “intellectual property” for purposes of any similar laws in any other country. The Parties further acknowledge that Xx Xxxx, as licensee of such rights under this Agreement, will retain and may fully exercise all of its protections, rights and elections under the Code, including Section 365(n) of the Code, and any similar laws in any other country. In the event of the commencement of a bankruptcy proceeding by or against Xxxx under the Code and any similar laws in any other country, Xx Xxxx will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and the same, if not already in its possession, will be promptly delivered to it (i) upon any such commencement of a bankruptcy proceeding upon its written request therefor, unless Xxxx elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under clause (i) above, following the rejection of this Agreement by or on behalf of Xxxx upon written request therefor by Xx Xxxx. All rights, powers and

remedies of Xx Xxxx provided for in this Section 13.3(l) are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, under the Code and any similar laws in any other country).

13.4 Survival. Expiration or termination of this Agreement shall not relieve the Parties of any rights or obligation accruing prior to such expiration or termination that by their nature prescribe continuing rights and obligations. Without limiting the foregoing, the following provisions shall survive the termination or expiration of this Agreement for any reason: Article 1, Section 2.4, Section 2.5, Section 2.9 (solely with respect to the last sentence), Section 8.3 to 8.6 (solely with respect to payment obligations accrued as of the effective date of termination), Section 8.7, Section 8.8, Section 8.9 (for the applicable time period set forth therein), Section 8.10, Section 9.1, Article 10, Section 11.4, Section 11.5, Article 12 (excluding Section 12.6), Section 13.1(b) (solely in the event of expiration), Section 13.3, Section 13.4, Section 13.5, Article 14, Article 15 (excluding Section 15.15).

13.5 Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies shall remain available except as agreed to otherwise herein.

ARTICLE 14

DISPUTE RESOLUTION

14.1 Disputes. The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 14 to resolve any controversy or claim arising out of, relating to, or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

14.2 Internal Resolution. With respect to all disputes arising between the Parties under this Agreement, including, without limitation, any alleged breach under this Agreement or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within [***] after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the Executive Officers of the Parties for attempted resolution by good faith negotiations within [***] after such notice is received.

14.3 Binding Arbitration.

(a) If the Parties fail to resolve the dispute through escalation to the Executive Officers under Section 14.2, and a Party desires to pursue resolution of the dispute, the dispute shall be submitted by either Party for resolution in arbitration administered by the International Chamber of Commerce (“ICC”) pursuant to its arbitration rules and procedures then in effect.

(b) The arbitration shall be conducted by a panel of three arbitrators experienced in the pharmaceutical business. Within [***] after initiation of arbitration, each Party shall select one person to act as arbitrator and the two Party-selected arbitrators shall select a third arbitrator (who shall be the chairperson of the arbitration panel) within [***] of their appointment. If the arbitrators selected by the Parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by ICC. If, however, the aggregate award sought by the Parties is less than [***] and equitable relief is not sought, the arbitration shall be conducted by a single arbitrator agreed by the Parties (or appointed by ICC if the Parties cannot agree).

(c) The seat and location of the arbitration shall be [***], and the language of the proceedings shall be English. The arbitral tribunal shall determine the dispute by applying the provisions of this Agreement and the governing law set forth in Section 15.6. The Parties agree that any award or decision made by the arbitral tribunal shall be final and binding upon them and may be enforced in the same manner as a judgment or order of a court of competent jurisdiction.

(d) By agreeing to arbitration, the Parties do not intend to deprive any court of its jurisdiction to issue, at the request of a Party, a pre-arbitral injunction, pre-arbitral attachment or other order to avoid irreparable harm, maintain the status quo, preserve the subject matter of the dispute, or aid the arbitration proceedings and the enforcement of any award. Without prejudice to such provisional or interim remedies in aid of arbitration as may be available under the jurisdiction of a competent court, the arbitral tribunal shall have full authority to grant provisional or interim remedies and to award damages for the failure of any Party to the dispute to respect the arbitral tribunal’s order to that effect.

(e) The existence and content of the arbitral proceedings and any ruling or awards shall be kept confidential by the Parties and members of the arbitral tribunal except (i) to the extent that disclosure may be required of a Party to fulfill a legal duty, protect or pursue a legal right, or enforce or challenge an award in bona fide legal proceedings before a state court or other judicial authority, (ii) with the consent of all Parties, (iii) where needed for the preparation or presentation of a claim or defense in the arbitration, (iv) where such information is already in the public domain other than a result of a breach of this clause, or (v) by order of the arbitral tribunal upon application of a Party.

(f) Each Party shall bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the administrator and the arbitrator; provided, however, the arbitrator shall be authorized to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, travel expenses, etc.), and/or the fees and costs of the administrator and the arbitrator.

(g) Notwithstanding anything in this Section 14.3, in the event of a dispute with respect to the validity, scope, enforceability or ownership of any Patent or other intellectual property rights, and such dispute is not resolved in accordance with Section 14.2, such dispute shall not be submitted to an arbitration proceeding in accordance with this Section 14.3, unless otherwise agreed by the Parties in writing, and instead either Party may initiate litigation in a court of competent jurisdiction in any country in which such rights apply.

ARTICLE 15

MISCELLANEOUS

15.1 Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, epidemic or pandemic, fire, floods, or other acts of God or any other deity, or acts, omissions or delays in acting by any Governmental Authority. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to mitigate such force majeure circumstances.

15.2 Assignment; Acquisition of Xxxx.

(a) Except as provided in Section 15.2(b) below, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the prior written consent of the other Party. Any attempted assignment not in accordance with the foregoing shall be null and void and of no legal effect. Any permitted assignee shall assume all assigned obligations of its assignor under this Agreement. The terms and conditions of this Agreement shall be binding upon, and shall inure to the benefit of, the Parties and their respected successors and permitted assigns.

(b) Notwithstanding the foregoing, either Party may, without consent of the other Party, assign this Agreement and its rights and obligations hereunder in whole or in part to (i) an Affiliate of such Party (which, in the case of Xx Xxxx as the assigner, Xx Xxxx shall remain

responsible for the performance of its Affiliate under this Agreement) or (ii) to a successor-in-interest in connection with a Change of Control of such Party, or in whole to its successor-in-interest in connection with the sale of all or substantially all of its stock or its assets to which this Agreement relates, or in connection with a merger, acquisition or similar transaction; provided, in the case of Xx Xxxx, under either of the foregoing (i) or (ii), that such assignee or successor-in-interest possesses at least comparable resources, capital and experience as Xx Xxxx, and in any event, at least sufficient resources, capital and experience to effectively perform its obligations hereunder.

(c) For clarity and notwithstanding any other provision of this Agreement, in the event of an Acquisition Transaction of Xxxx, [***].

15.3 Performance by Affiliates. Each Party may discharge any obligations (other than the payment obligations set forth under Article 8) and exercise any right hereunder through any of its Affiliates, without notice to and without consent from, the other Party, and each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance.

15.4 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

15.5 Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if (a) delivered personally, (b) sent by nationally-recognized overnight courier, or (c) sent by registered or certified mail, postage prepaid, return receipt requested, in each case (a)—(c), accompanied by an email stating the same, and addressed as follows:

If to Xxxx:

Xxxx Therapeutics, Inc.

Address: 000 Xxxxxx Xxxx Xxxxxx, Xxx Xxx, XX

Attn: XXXX Therapeutics

Email: [***]

with a copy (which shall not constitute notice) to:

[***]

If to Xx Xxxx:

Ji Xing Pharmaceuticals Limited

c/o [***]

[***]

Attn: [***]

Email: [***]

with a copy (which shall not constitute notice) to:

Ropes & Gray LLP

00/X, Xxxx Xxxxx

0000 Xxxxxxx Xxxx Xxxx

Shanghai, The People’s Republic of China

Attn: [***]

Email: [***]

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given (x) when delivered if personally delivered or sent by facsimile on a Business Day; (y) on the second Business Day after dispatch if sent by internationally-recognized overnight courier; or (z) on the fifth Business Day following the date of mailing if sent by mail.

15.6 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, U.S., without giving effect to any choice of law principles that would require the application of the laws of a different jurisdiction. The application of the U.N. Convention on Contracts for the International Sale of Goods is excluded.

15.7 Entire Agreement; Amendments. This Agreement, together with the Exhibits attached hereto, contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, with regard to the subject matter hereof (including the licenses granted hereunder) are superseded by the terms of this Agreement. Neither Party is relying on any representation, promise, nor warranty not expressly set forth in this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.

15.8 Headings. The captions to the several Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the Sections of this Agreement.

15.9 Independent Contractors. It is expressly agreed that Xxxx and Xx Xxxx shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Xxxx nor Xx Xxxx shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

15.10 Waiver. The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.

15.11 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

15.12 Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

15.13 Business Day Requirements. In the event that any notice or other action or omission is required to be taken by a Party under this Agreement on a day that is not a Business Day then such notice or other action or omission shall be deemed to be required to be taken on the next occurring Business Day.

15.14 Translations. This Agreement is in the English language only, which language shall be controlling in all respects, and all versions hereof in any other language shall be for accommodation only and shall not be binding upon the Parties. All communications and notices to be made or given pursuant to this Agreement, and any dispute proceeding related to or arising hereunder, shall be in the English language. If there is a discrepancy between any translation of this Agreement and this Agreement, this Agreement shall prevail.

15.15 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as necessary or appropriate in order to carry out the purposes and intent of this Agreement.

15.16 Construction. Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words “include”,

“includes” and “including” shall be deemed to be followed by the phrase “without limitation”, (c) the word “will” shall be construed to have the same meaning and effect as the word “shall”, (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person shall be construed to include the person’s successors and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Sections, Schedules, or Exhibits shall be construed to refer to Sections, Schedules or Exhibits of this Agreement, and references to this Agreement include all Schedules and Exhibits hereto, (h) the word “notice” means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree”, “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or Section, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term “or” shall be interpreted in the inclusive sense commonly associated with the term “and/or.”

15.17 Counterparts. This Agreement may be executed in counterparts, each of which counterparts, when so executed and delivered, will be deemed to be an original, and all of which counterparts, taken together, will constitute one and the same instrument even if both Parties have not executed the same counterpart. Signatures provided by facsimile transmission or in Adobe^™ Portable Document Format (PDF) sent by electronic mail will be deemed to be original signatures.

{Signature Page Follows}

IN WITNESS WHEREOF, the Parties intending to be bound have caused this License and Collaboration Agreement to be executed by their duly authorized representatives as of the Effective Date.


XXXX THERAPEUTICS, INC.		JI XING PHARMACEUTICALS HONG KONG LIMITED

By:	/s/ Xxxxx Xxxxxxxxxxxxxxx	By:	/s/ Xxxxxx Xxxxxxxxx

Name:	Xxxxx Xxxxxxxxxxxxxxx	Name:	Xxxxxx Xxxxxxxxx

Title:	Chief Executive Officer	Title:	Chief Executive Officer

Date:	April 12, 2022	Date:	April 13, 2022

[SIGNATURE PAGE TO LICENSE AND COLLABORATION AGREEMENT]

List of Exhibits

Exhibit A: Compound

Exhibit B: Existing Licensed Patents

Exhibit C: Initial Technology Transfer Plan3

List of Schedules

Schedule 4.4: Initial Technology Transfer Materials

Exhibit A

Compound

[***]

Exhibit B

Existing Licensed Patents

[***]

Exhibit C

Initial Technology Transfer Plan

[***]

Schedule 4.4

Initial Technology Transfer Materials

[***]

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Table of Contents

LICENSE AND COLLABORATION AGREEMENT

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