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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS EXHIBIT (INDICATED BY [***]) HAS BEEN OMITTED PURSUANT TO ITEM 601(B)(10) OF REGULATION S-K BECAUSE IT IS BOTH NOT MATERIAL
AND IS THE TYPE THAT INVENTIVA S.A. TREATS AS PRIVATE OR CONFIDENTIAL.
EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT
Exclusive License and Collaboration Agreement (the "Agreement") is entered into as of September 21,
2022 (the "Effective Date"), by and between Inventiva S.A.,
a company incorporated under the laws of France, having its principal place of business at 50, rue de Dijon Daix (21121), France
("Inventiva"), and Chia Tai Tianqing Pharmaceutical Group, Co., Ltd.,
a limited liability company incorporated and existing under the laws of the People's Republic of China, having its registered office
located at No.369 South Yuzhou RD., HaiZhou District, Lianyungang, Jiangsu Province, Mainland China ("Licensee").
has rights to the small molecule known as lanifibranor (IVA337);
Licensee is engaged in the research, development and commercialization of pharmaceutical products; and
Licensee desires to obtain from Inventiva, and Inventiva desires to grant to Licensee, an exclusive license under the Inventiva
Technology to Develop, import, export (within the Licensee Territory), use, Manufacture, offer for sale, promote, market, distribute,
sell and otherwise Commercialize the Licensed Products in the Field in the Licensee Territory (each as defined below), subject to the
terms and conditions of this Agreement.
Therefore, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, Inventiva and Licensee hereby agree as follows:
Active(s)" mean any active pharmaceutical ingredient(s) that is not the Licensed Compound.
shall mean any company or entity controlled by, controlling, or under common control with a Party or another entity. For the purpose of
this definition, an entity shall be deemed to "control" another entity, if it owns directly or indirectly, more
than fifty percent (50%) of the outstanding voting securities, capital stock, or other comparable equity or ownership interest of such
entity, or exercises equivalent influence over such entity. For the purpose of this Agreement, an "Affiliate" of Licensee
shall not include [***].
Annual Net Sales" shall mean aggregate Net Sales of all Licensed Products by Licensee, its Affiliates and Sublicensees in the
Field in the Licensee Territory (i.e., for any and all indications) in a Calendar Year.
Manager" shall mean the employee appointed by each Party to serve as the single primary point of contact and to facilitate communication
between the Parties for all matters related to this Agreement.
Laws" shall mean the applicable provisions of any and all national, supranational, regional, state and local laws, treaties,
statutes, rules, regulations, administrative codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, permits
(including Regulatory Approvals) of or from any court, arbitrator, Regulatory Authority or governmental agency or authority having jurisdiction
over or related to the subject item or subject person, including all anti-bribery and anti-corruption laws, applicable export control
laws and other comparable laws.
Experience" means, with respect to a Licensed Product, any untoward medical occurrence in a patient or clinical investigation
subject administered such Licensed Product, and which does not necessarily have a causal relationship with the treatment for which such
Licensed Product is used, including any unfavourable and unintended sign (including an abnormal laboratory finding),, symptom, or disease
temporally associated with the use of such Licensed Product or the worsening in severity of a pre-existing condition after administration
of such Product, in each case, whether or not related to such Licensed Product.
Day" shall mean any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by law to close
in France or the Mainland China.
Quarter" shall mean each period of three (3) consecutive months commencing on January 1, April 1, July 1
Semi-Annual Period" shall mean each period of six (6) consecutive months commencing on January 1 or July 1.
Year" shall mean each period of twelve (12) consecutive months commencing on January 1.
of Control" means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial
ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party
is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such
Third Party is, directly or indirectly, the beneficial owner of voting securities representing at least fifty percent (50%) of the total
voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation, recapitalization, or
reorganization of such Party is consummated which would result in shareholders or equity holders of such Party immediately prior to such
transaction, no longer owning at least fifty percent (50%) of the outstanding voting securities of the surviving entity (or its parent
entity) immediately following such transaction; or (c) there is a sale or transfer to a Third Party of all or substantially all
of such Party's consolidated assets taken as a whole, through one or more related transactions.
Information" shall mean information related to the Chemistry, Manufacturing and Controls of the Licensed Products, as specified
by the applicable Regulatory Authorities.
1.13. "Commercialization"
shall mean, with respect to a product, all activities undertaken before and after obtaining Regulatory Approvals relating specifically
to the pre-launch, launch, promotion, detailing, medical education and medical liaison activities, marketing, pricing, reimbursement,
sale, and distribution of such product, including strategic marketing, sales force detailing, advertising, market product support, all
customer support, product distribution, and invoicing and sales activities, but excluding Development and Manufacture. "Commercialize"
and "Commercializing" shall have the correlative meanings.
Reasonable Efforts" shall mean, with respect to a Party's obligation under this Agreement to conduct a particular activity,
that level of efforts and resources required to carry out such obligation consistent with the efforts a similarly-situated pharmaceutical
or biotechnology company devotes to a compound or product of its own at a similar stage of research, development or commercialization.
A Party that is required to use Commercially Reasonable Efforts with respect to a task or obligation must: (i) promptly assign
responsibility for such task or obligation to specific employees who are held accountable for progress and monitor such progress on an
ongoing basis, (ii) set and consistently seek to achieve specific, meaningful and measurable objectives for carrying out such task
or obligation, and (iii) consistently make and implement decisions and allocate resources designed to advance progress with respect
to such task or obligation.
Product" means a pharmaceutical product that contains both the Licensed Compound and one (1) or more Additional Active(s),
whether co-formulated in a single pharmaceutical product or as a co-packaged product. For the avoidance of doubt, a pharmaceutical product
containing an Additional Active that is co-administered with a pharmaceutical product containing the Licensed Compound will not be a
Combination Product.
Information" shall mean all Information and other proprietary scientific, marketing, financial or commercial information or
data, which is generated by or on behalf of a Party or its Affiliates and which one Party or any of its Affiliates has furnished or made
available to the other Party or its Affiliates, whether in oral, written or electronic form. The existence and terms of this Agreement
shall be deemed Confidential Information of each Party.
(including any variations such as "Controlled" and "Controlling") shall mean, with respect
to any material (including Regulatory Materials), Information, Patents or other intellectual property rights, possession by a Party
of the right, power and authority (whether by ownership, license or otherwise, other than by virtue of any rights granted under this
Agreement) to grant access to, to grant use of, or to grant a license or a sublicense to such Information, Patents or intellectual property
rights by such Party without violating the terms of any agreement or other arrangement with any other party or incurring additional payment
obligations of such Party.
shall mean, with respect to Patent, a Valid Claim thereof would (absent a license or ownership thereof) be infringed by the Manufacturing,
use, offering for sale, sale or importation of Licensed Products. "Covered" and "Covering" shall
have the correlative meanings.
Labeling" shall mean, with respect to a pharmaceutical product (Product X), the reference on its label to the use of
another pharmaceutical product (Product Y) in combination with Product X with respect to an indication.
shall have the meaning provided in Section 2.2(a).
shall mean all data, including but not limited to CMC Information, non-clinical data, preclinical data and clinical data, generated by
or on behalf of a Party or its Affiliates or their respective (sub)licensees pursuant to activities conducted under this Agreement and
all data with respect to the Licensed Compound or Licensed Products, regardless of whether the data are generated before or after the
shall mean, with respective to a product, (i) all activities conducted after the Effective Date relating to non-clinical and clinical
trials/studies, toxicology testing, statistical data analysis, publication and presentation of study results with respect to such product,
(ii) the reporting, preparation and submission of regulatory applications for obtaining, registering and maintaining Regulatory Approval
of such product, (iii) all regulatory affairs related to any of the foregoing. "Develop" and "Developing"
shall have the correlative meanings.
Plans" shall mean [***].
Party" shall have the meaning provided in Section 10.1.
shall have the meaning provided in Section 15.1.
shall have the meaning provided in Section 2.2(a).