Exhibit 10.7

[******] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

EXECUTION VERSION

License Agreement

This License Agreement (this “Agreement”) is made and entered into on the 16th day of July, 2021 (“Effective Date”) by and between Cancer Prevention Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware, having a place of business at 1760 East River Road, Suite 250, Tucson, Arizona 85718 (“CPP”), and One-Two Therapeutics Assets Limited, a company organized and existing under the laws of Ireland, having a place of business at Carrick House, 49 Fitzwilliam Square, Dublin 2, Ireland (“One- Two”). CPP and One-Two are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”

Recitals

WHEREAS, CPP is a pharmaceutical company that develops therapies for people with elevated risk for cancer;

WHEREAS, CPP is engaged in developing the Product (as defined below) for the treatment or prevention of colorectal neoplasms, including the FAP Product (as defined below);

WHEREAS, CPP owns, holds, licenses or controls certain regulatory filings, data and intellectual property rights related to the Products;

WHEREAS, CPP has contracted with Sanofi (as defined below) for the manufacture of the Product;

WHEREAS, One-Two is engaged in the business of developing, marketing, promoting, importing, selling and distributing pharmaceutical products;

WHEREAS, One-Two wishes to receive, and CPP wishes to grant One-Two, an exclusive license to Develop and Commercialize the Product in the Territory, and a non- exclusive license to Manufacture the Product in the Territory, all as described in more detail below;

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

Article 1

Definitions

The terms in this Agreement with initial letters capitalized shall have the meanings set forth below, or the meaning as designated in the indicated places throughout this Agreement.

1.5       “Affiliate” means, with respect to a Party, any Entity that controls, is controlled by, or is under common control with such Party at the time at which the determination of affiliation is being made, but only for the period of time that such Person meets the definition of Affiliate hereunder. For the purpose of this definition, “control” means (a) if the Entity is a corporation, direct or indirect ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors for such corporation, (b) if such Entity is any type of legal entity other than a corporation, (i) fifty percent (50%) or more of the equity interest in such legal entity, or (ii) if such Entity is a partnership, status as a general partner in any such partnership, and (c) any other arrangement whereby such Entity controls or has the right to control the board of directors or equivalent governing body of the other, or the ability to cause the direction of the management or policies of the other. Notwithstanding the foregoing, for purposes of this Agreement One-Two shall be considered an Affiliate of QOL.

1.9      “Arizona Payment Obligations” means all payments, if any, that will or may become due and payable to the University of Arizona under the Arizona License Agreement as a result of any of the activities performed by or on behalf of either Party or their sublicensees under this Agreement or the Services Agreement.

1.10     “Business Day” means a day other than (a) a Saturday or Sunday, or (b) a day on which commercial banks located in New York, New York are authorized or required by Law to be closed.

1.11     “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

1.12     “Calendar Year” means a period of twelve (12) consecutive months ending on December 31.

1.13    “Change of Control” means, with respect to a Party (an “Acquired Person”), from and after the Effective Date, a transaction involving such Acquired Person in which: (a) any Person or group of Persons becomes the beneficial owner (directly or indirectly) of more than fifty percent (50%) of the voting shares of such Acquired Person, (b) such Acquired Person consolidates with or merges into or with another Person pursuant to a transaction in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger is not held by the holders of the outstanding voting shares of such Acquired Person immediately preceding such consolidation or merger, or (c) that Acquired Person sells or transfers to another Person all or substantially all of its assets or all rights, title and interest in and to the Product. Notwithstanding the foregoing, the following shall not constitute a Change of Control: (i) a sale of capital stock to underwriters in an underwritten public offering of a Party’s capital stock solely for the purpose of financing, (ii) the acquisition of securities of the Acquired Person by any Person or group of Persons that acquires the Acquired Person’s securities in a transaction or series of related transactions the primary purpose of which is to obtain financing for the Acquired Person through the issuance of equity securities, or (iii) a transaction solely to change the domicile of a Party.

1.14   “Claims” means all Third Party demands, claims, actions, proceedings, orders, findings and verdicts (whether criminal or civil, in contract, tort or otherwise) seeking or awarding losses, damages, legal costs, other expenses of any nature, or equitable remedies of any nature, including restitution and injunctive relief.

1.19    “Commercialize” or “Commercialization” means any and all activities directed to the marketing and commercialization of the Product after Regulatory Approval, including pre- launch and post-launch marketing, promoting, distribution, detailing or commercially selling or offering to sell the Product (as well as importing and exporting activities in connection therewith); provided that to the extent a distinction between Commercialization, Development and Manufacturing activities is relevant, “Commercialize” and “Commercialization” shall exclude activities related solely to Development or Manufacturing. When used as a verb, “Commercialize” means to engage in Commercialization.

1.22    “Contractor” means any Entity (including CPP, any One-Two Affiliate or any Third Party) that is retained by One-Two or its Affiliate to perform Development, Manufacturing or Commercialization activities on One-Two’s behalf pursuant to the terms and conditions of this Agreement.

1.23   “Control” or “Controlled” means, with respect to any Know-How, material, Patents, other intellectual property, Study Data, Regulatory Filing, Regulatory Approval, or any proprietary or trade secret information, and subject to Section 15.2(b) the legal authority or right (whether by ownership, license or otherwise), as of the Effective Date or during the Term, to: (a) grant ownership of or a license or a sublicense under such Know-How, Patents, or intellectual property, Study Data, Regulatory Filing, or Regulatory Approval; or (b) otherwise disclose such proprietary or trade secret information, Study Data or Regulatory Filing; in each case without breaching the terms of any agreement with, obligation to or other arrangement with a Third Party, or misappropriating the proprietary or trade secret information of a Third Party and in each case as provided in this Agreement.

1.24   “Cover” or “Covering” means, with respect to a Patent or claim of a Patent and the Product, that the making, use, sale, offer for sale or importation of the Product would infringe such claim or Patent (or in the case of a pending patent application, if the claims of such patent application as then existing were issued), but for the licenses granted in this Agreement.

1.30    “Data Package” means, with respect to a clinical study, all of the following: (a) an electronic copy of the final study report meeting the requirements of 21 C.F.R. 58.185 for such study, provided such final study report is required to be submitted for such clinical study under applicable Law; (b) an electronic copy of datasets for such clinical study to the extent owned or Controlled by the Party preparing the Data Package; (c) all protocols for the performance of such clinical study (as they may be amended from time to time); and (d) a copy of all correspondences between a Party and the applicable Regulatory Authority regarding such clinical study.

1.31   “Debarred” means that a Party or any of its officers or directors or any other personnel (or other permitted agents of a Party hereunder) has been: (a) convicted of any of the offenses identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. §1320a-7 (http://oig.hhs.gov/exclusions/authorities.asp); (b) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (http://exclusions.oig.hhs.gov/) or listed as having an active exclusion in the System for Award Management (http://www.sam.gov); (c) debarred pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b)) as published in the FEDERAL REGISTER (http://www.gpoaccess.gov/fr/); (d) disqualified or proposed by FDA for disqualification from receiving investigational products or conducting clinical studies; or (e) listed by any US Federal agency as being suspended, proposed for debarment, debarred, excluded or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a.

1.37    “Develop” or “Development” means any and all research and development activities for the Product (including placebos and comparators) relating to the Product, including all non-clinical, preclinical and clinical activities, testing and studies of the Product, manufacturing process development, toxicology studies, distribution of Products for use in clinical trials, research and development of companion diagnostics for use in connection with clinical trials of Products as well as approved Products, statistical analyses, and the preparation, filing and prosecution of any Marketing Approval Application and obtaining or maintaining Regulatory Approvals for the Product, as well as all regulatory affairs related to any of the foregoing. When used as a verb, “Develop” means to engage in Development.

1.42    “Eflornithine” means the compound eflornithine or an enantiomer or a mixture of enantiomers thereof, or a pharmaceutically acceptable salt, solvate, hydrate, co-crystal, clathrate, tautomer, prodrug, isotopolog, or polymorph thereof.

1.44    “Entity” means a partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization.

1.48     “FAP” means familial adenomatous polyposis, whether cancerous or non- cancerous, genetic, sporadic or otherwise.

1.51    “FAP Pivotal Trial” means the Phase 3 clinical trial identified as of the Effective Date as NCT01483144 that is titled Phase III Trial of the Safety and Efficacy of Eflornithine Combined with Sulindac Compared to Eflornithine, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis.

1.52    “FAP Product” means CPP-IX/Sul, a combination pharmaceutical product formulated for oral delivery for the FAP Indication in adults containing both Active Ingredients, as described in the CPP NDA.

1.53    “FDA” means the United States Food and Drug Administration or any successor entity thereto performing substantially the same functions.

1.54    “Field” means the treatment, prevention and diagnosis of human diseases and conditions.

1.55   “First Commercial Sale” means, with respect to a Product in any country in the Territory, the first (1st) commercial sale such Product by or on behalf of One-Two or its Affiliates or its or their Sublicensees to a Third Party for use or consumption of such Product in such country (other than sublicensees for distribution, use or consumption of any such Product in such country or jurisdiction) after the Regulatory Approvals and any required Pricing Approvals have been obtained for such Product in such country in the Territory.

1.56   “Government Authority” means any federal, state, national, regional, provincial or local government, or political subdivision thereof, or any multinational organization or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body).

1.57    “IND” means an investigational new drug application as such term is used in 21 CFR Part 312 or its successor regulation, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformity with the requirements of such Regulatory Authority.

1.67    “Invention” means inventions, discoveries, copyrightable materials, designs, processes, manufacturing techniques, trade secrets, formulae or Know-How, whether or not patentable.

1.68   “Know-How” means all confidential compositions of matter, techniques and data and other know-how and information of a technical, scientific, business or other nature, including improvements and developments, practices, manufacturing information and processes, formulations, assays, discoveries, improvements, modifications, processes, methods, clinical and regulatory strategies, protocols, formulae, utility, lab and clinical trial data, results, inventions, know-how and trade secrets, patentable or otherwise, and all other scientific, marketing, financial and commercial information or data.

1.70     “Law” means any federal, state, local, foreign or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order by any Government Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.

1.71     “Licensed IP” means the Licensed Patents, Licensed Marks and Licensed Know-How.

1.72     “Licensed Know-How” means any and all Know-How or other information owned or Controlled by CPP or any of its Affiliates as of the Effective Date or thereafter during the Term that relates to or is otherwise reasonably necessary for the use, Development, Manufacture or Commercialization of the Product, including with respect to placebos and comparators for the Product.

1.73     “Licensed Marks” means the Marks that are set forth in Exhibit B as well as graphical representations, symbols, or logos related thereto, which may be used in connection with the Commercialization of the Products in the Territory, including the trade dress, style of packaging and internet domain names used in connection with the Commercialization of the Product(s) in the Territory.

1.74     “Licensed Patents” means (a) the Patents that are set forth in Exhibit A and (b) any and all Patents that are Controlled by CPP or any of its Affiliates as of the Effective Date or thereafter during the Term that Cover any of the Products. Licensed Patents will not include any Patents that Cover a product that is not a Product.

1.75    “Manufacture” means the manufacture of the Product and components thereof, including the Active Ingredients, in each case including any and all activities directed to receipt, incoming inspections, storage and handling of raw materials and the manufacture, manufacturing process development, scale-up and validation, processing, formulation, packaging, labeling, warehousing, quality control testing (including in-process release and stability testing), supplying, shipping and release of the Product; provided that, to the extent a distinction between Commercialization, Development and Manufacturing activities is relevant, “Manufacture” shall exclude manufacturing process development activities related solely to Development and not directly related to the manufacture of Product for commercial sale.

1.76    “Mark” shall mean any brand, trademark, service mark, trade dress, trade name, corporate name, business name, domain name, logo, design, or product or service source identifier, including, any word, name, stylization, symbol, color, designation, or device, or any combination thereof, that functions as a source identifier, together with the goodwill connected with the use thereof and symbolized thereby, whether or not subject to a registration or application for a registration.

1.77    “Marketing Approval Application” means an NDA or similar application for Regulatory Approval that is filed with the applicable Regulatory Authorities in any country or jurisdiction.

1.83    “NDA” means a new drug application for Regulatory Approval of a Product that is filed with the FDA or its equivalents outside of the United States in the Territory. For the avoidance of doubt, an NDA is a Marketing Approval Application.

1.84    “Net Sales” means, for the applicable measurement period, with respect to a Product, the sum of (without duplication) (a) One-Two Sublicensing Fixed Payments and (b) the gross invoiced sales price on sales of such Product by One-Two or any of its Affiliates or, subject to Section 5.1(c), its or their Sublicensees to an unaffiliated Third Party purchaser in an arm’s-length transaction for the sale of such Product, less the following deductions for such Product, determined in accordance with U.S. generally accepted accounting principles:

(i)        trade, cash and/or quantity discounts, sales returns and allowances, deductions, fees and credits, excluding sales commissions for commercialization;

(ii)      excise Taxes, use Taxes, tariffs, sales Taxes and customs duties and/or other Taxes (including value-added Taxes (VAT)), government charges or fees imposed on the sale of Product (to the extent these are reflected in relevant invoices), but specifically excluding, for clarity, any income or corporation Taxes assessed against or by reference to the income or profit arising from such sales;

(iii)     compulsory or negotiated payments and cash rebates or other expenditures to governmental authorities (or designated beneficiaries thereof) in the context of any national or local health insurance programs or similar programs, including, but not limited to, pay-for-performance agreements, risk sharing agreements and government- levied fees as a result of the Patient Protection and Affordable Care Act, Pub. L. No. 111- 148 or any other successor program;

(iv)      rebates, chargebacks, administrative fees and discounts (or equivalent thereof) to managed health care organizations, group purchasing organizations, insurers, pharmacy benefit managers (or equivalent thereof), specialty pharmacy providers, governmental authorities, or their agencies or purchasers, reimbursers, or trade customers, as well as amounts owed to patients through co-pay assistance cards or similar forms of rebate to the extent the latter are directly related to the prescribing of Product;

(v)        outbound freight, shipment, insurance and other distribution costs to the extent included in the invoiced price and separately itemized on the invoice;

(vi)      retroactive price reductions, credits or allowances actually granted upon claims, rejections or returns of Product, including for recalls or damaged or expired goods, billing errors and reserves for returns;

(vii)     any invoiced amounts that are uncollectable by One-Two or its Affiliates, including bad debts, provided that such amounts, if and when collected, by One-Two or its Affiliates shall be included in a revised Net Sales calculation; and

(viii)    in respect of sales outside the United States, deductions in the applicable jurisdiction that are substantially similar to deductions otherwise set forth in clauses (i) through (vii), above, but because of local applicable law, practices and customs may not conform in terminology to the deductions set forth in the said clauses (i) through (vii).

All the aforementioned deductions shall be allowable as incurred or accrued based on One- Two’s and its Affiliates’ reporting system. In no event will any particular amount identified above be deducted more than once in calculating Net Sales, or will sales or One-Two Sublicensing Fixed Payments be included more than once in calculating Net Sales. In no event will any particular amount identified above result in an adjustment that exceeds the Net Sales amount such that CPP would owe One-Two a payment for such adjustment.

Net Sales will be determined from the books and records of One-Two or any of its Affiliates or Sublicensees maintained and consistently applied from time to time in accordance with U.S. generally accepted accounting principles, or, in the case of Sublicensees, such similar accounting principles as consistently applied. Each Party further agrees in determining such amounts, it will use such Party’s then-current standard procedures and methodology consistently applied, including such Party’s then-current standard exchange rate methodology for the translation of foreign currency sales into U.S. dollars or, in the case of sublicensees, such similar methodology, consistently applied.

For clarity, (x) sales of a Product by and between One-Two and any of its Affiliates or Sublicensees shall not be considered sales to unaffiliated Third Parties and shall be excluded from Net Sales calculations for all purposes and (y) only a single sales transaction with respect to a particular unit of Product, made at the time One-Two or any of its Affiliates or Sublicensees sells such unit of Product to an unaffiliated Third Party purchaser in arms-length transaction, will qualify as the basis for determining the Net Sales amount in clause (b) of this definition of Net Sales for such unit of Product.

Notwithstanding the foregoing, the following sales of a Product shall be excluded from Net Sales calculations for all purposes: (i) transfer or dispositions of such Product at no cost for promotional, charitable, pre-clinical, regulatory, governmental or educational purposes; (ii) transfers or dispositions of such Product as free samples or donations, or for patient assistance, testing marketing programs or other similar assistance or programs at no cost; and (iii) use or sale of such Product for clinical trial or other scientific testing purposes, early access programs (such as to provide patients with such Product prior to marketing approval pursuant to treatment INDs or protocols, named patient programs or compassionate use programs) or any similar use.

1.92     “One-Two Sublicensing Fixed Payment” means, for the applicable measurement period and only with respect to the Development or Commercialization of the Products in the Territory, the gross amount of any upfront license fees, milestone payments or other similar fixed payments received by One-Two or its Affiliates from Sublicensees of the Products in the Territory; provided, however, that royalty payments calculated based on sales of Products in the Territory are not included in the definition of One-Two Sublicensing Fixed Payment. For the avoidance of doubt, neither any amounts included in the calculation under clause (b) of the definition of Net Sales nor amounts that in accordance with Section 10.3(c) are excluded from the calculation under clause (b) of the definition of Net Sales will be included in the definition of One-Two Sublicensing Fixed Payment.

1.99    “Patents” means all patents and patent applications and any patents issuing therefrom (which for the purpose of this Agreement shall be deemed to include certificates of invention and applications for certificates of invention), including all divisionals, continuations, substitutions, continuations-in-part, converted provisionals, continued prosecution applications, adjustments, re-examinations, reissues, additions, renewals, revalidations, extensions (including patent term extensions, and supplemental certificates and the like), registrations, pediatric exclusivity periods of any such patents and patent applications, Patent Cooperation Treaty (PCT) applications, provisional applications, non-provisional applications, priority applications and any and all foreign equivalents of the foregoing.

1.104  “Phase 3 Trial” means, in reference to a clinical trial of a Product, (a) a trial that would satisfy the requirements for a Phase 3 study as defined in 21 C.F.R. § 312.21(c) or (b) a Phase 3 study as defined in the ICH E8 Guideline (or, in either case, any amended or successor regulation or guideline).

1.105  “Pivotal Trial” means a clinical trial or study that is intended to provide or does provide sufficient evidence of efficacy and safety to support a Regulatory Approval; the Parties acknowledge and agree that a Pivotal Trial is most likely to be a Phase 3 Trial and that phase II trials are rarely pivotal trials. To qualify as a Pivotal Trial, a phase II trial must be accepted as pivotal by the Regulatory Authority as a sufficient basis for Regulatory Approval.

1.106  “Pricing Approvals” means, with respect to the Product in any country or jurisdiction, all pricing and reimbursement approvals for the Product from Government Authorities required by applicable Law or Governmental Authorities.

1.107  “Product” means any combination pharmaceutical product in a finished form containing both Active Ingredients, together as the sole active ingredients or both together in combination with additional active ingredients, that is used for the treatment or prevention of any disease or condition, including the treatment of colon cancer risk reduction and pancreatic cancer. For the avoidance of doubt, the FAP Product is a Product. “Product” does not include any product configuration that contains only one of the Active Ingredients.

1.111   “Regulatory Approval” means, with respect to the Product in any country or jurisdiction, the approvals by the applicable Regulatory Authority in such country or jurisdiction (other than Pricing Approvals) necessary for the Commercialization of such Product, including under 21 CFR 314.

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

1.113  “Regulatory Exclusivity” shall mean with respect to the Territory, any market protection, other than patent protection, granted by a Regulatory Authority in the Territory which confers an exclusive exploitation period during which: One-Two or its Affiliates have the exclusive right to market, price, and sell a Product in the Territory through a regulatory exclusivity right, such as new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity.

1.114  “Regulatory Filings” means, with respect to Product, any submission to a Regulatory Authority of any appropriate regulatory application specific to Products, including all INDs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents and supplements thereto. “Regulatory Filings” includes any NDA and any Marketing Approval Application.

1.117  “Representatives” means, with respect to a Person, such Person’s officers, directors, managers, employees, general partners, outside counsel, financial advisors, consultants and agents.

1.118  “Right of Reference” shall mean the “right of reference or use” defined in 21 CFR 314.3(b), or its equivalents outside the United States, and shall in any event include the right to allow the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Filings (and any data contained or referenced therein) filed with such Regulatory Authority.

1.119  “Royalty Term” shall mean, with respect to a Product in the Territory, on a country-by-country and indication-by-indication basis, the period beginning on the date of First Commercial Sale of such Product by or on behalf of One-Two, any of its Affiliates or Sublicensees in such country and the latest of (i) the last to expire Valid Claim of any CPP Patents that Cover such Product in such country, including methods of manufacture or uses to treat certain indications, (ii) the date on which the Product has no Regulatory Exclusivity in such country for such indication, or (iii) the date that is 15 years from the date of First Commercial Sale of such Product in such country for such indication.

1.125  “Sponsor” means an Entity that has responsibility for and initiates a clinical investigation as further described in 21 CFR 312.3(b).

1.126  “Study Data” means, with respect to clinical studies, all technical or scientific information, data (including all raw data), results and analyses made, collected or otherwise generated in connection with the conduct of any phase of such clinical studies, including all biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds), clinical samples and biological methodology.

1.127  “Sublicensee” means a Third Party to whom One-Two or one of its Affiliates has granted a sublicense of any of the rights granted to One-Two under Section 5.1(a).

1.128  “Sulindac” means the compound sulindac or an enantiomer or a mixture of enantiomers thereof, or a pharmaceutically acceptable salt, solvate, hydrate, co-crystal, clathrate, tautomer, prodrug, isotopolog, or polymorph thereof.

1.131   “Taxes” means any and all taxes, customs duties, tariffs, levies, assessments, or other government charges or fees in the nature of taxation.

1.135   “Territory” means the United States of America and Canada, in each case, including its territories and possessions, and excluding any such country that is a Terminated Country, as of the date such country becomes a Terminated Country.

1.140 “Transaction Documents” means this Agreement, and upon it becoming effective, the Pharmacovigilance Agreement, Services Agreement, including in each case all exhibits and attachments thereto.

1.141   “United States” or “U.S.” means the United States of America including its territories and possessions.

1.144  “Valid Claim” shall mean: (a) a claim of any issued and unexpired patent that (i) has not been dedicated to the public, disclaimed, revoked or held unenforceable or invalid by a decision of a Governmental Authority of competent jurisdiction from which no appeal can be taken, or a decision of a Governmental Authority of competent jurisdiction that can be appealed, but with respect to which an appeal has not taken within the time allowed for appeal, and (ii) has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (b) a claim of any pending patent application that (i) has not been cancelled, withdrawn or abandoned, without being re-filed in another application in the applicable jurisdiction, (ii) has not been finally rejected by an administrative agency or other governmental action from which no appeal can be taken and (iii) has not been pending or filed more than seven (7) years from the earliest possible priority date for such patent application; provided that if such claim is later issued, it shall from the issuance date forward be deemed to be a Valid Claim.

Article 2

Clinical Development

2.1       General. CPP has Developed the FAP Product for the treatment or prevention of FAP in adults and Product for the treatment or prevention of colorectal neoplasms at CPP’s cost. As of the Effective Date, the FAP Product is the subject of one (1) ongoing clinical study sponsored by CPP, referred to as the PACES Trial (as further described below), which is being conducted under IND 103. The Parties acknowledge and agree that, in accordance with and subject to the terms and conditions of this Agreement, from and after the Effective Date, subject to Section 2.2(b), (a) One-Two shall have the exclusive right to Develop the Products in the Field in the Territory and (b) participation by CPP in any further Development of the Product in the Field in the Territory shall be for the benefit of One-Two, pursuant to the Services Agreement.

(i)      As of the Effective Date, CPP is the Sponsor of the clinical trial titled, “S0820, Adenoma and Second Primary Prevention Trial (PACES)” (the “PACES Trial”) under which the Product is being used to treat or prevent sporadic colorectal neoplasms (“PACES Indication”).

(ii)      The PACES Trial is being conducted under IND 103 and is managed by SWOG, a nonprofit organization dedicated to improving lives through cancer clinical trials and translational research (“SWOG”). The PACES Trial is funded in part by the National Cancer Institute.

(iii)      Under that certain Agreement by and between SWOG, SWOG Clinical Trials Initiative, LLC and CPP dated February 22, 2011, as amended (“SWOG Agreement”) and that certain agreement by and between the National Cancer Institute and CPP dated November 10, 2010, as amended (“NCI Agreement” and, together with the SWOG Agreement, the “PACES Agreements”), CPP is obligated to supply Product for use in the PACES Trial at CPP’s cost, and in exchange CPP receives certain data and regulatory rights with respect to the PACES Trial.

(b)       PACES Agreements Obligations. Until the PACES Agreements are assigned to One-Two in accordance with Section 3.2 below, and unless otherwise agreed between the Parties in writing: (i) CPP shall continue performing its obligations under the PACES Agreement for as long as such agreements are in full force and effect, in each case at One-Two’s sole cost and expense (which payment obligations are detailed on Schedule 2.2(b) hereto), (ii) CPP shall not agree to extend the term of either of the PACES Agreements, to otherwise amend either of the PACES Agreements, or to waive any obligations of the other parties to either of the PACES Agreements without One-Two’s prior written consent, and (iii) in the event CPP receives notice from another party to either of the PACES Agreements of matters relating to the PACES Trial or rights or obligations of the parties under the PACES Agreements (including (x) in reference to the SWOG Agreement, notice of Institution Inventions(s), requests for consent to the sale, license or use of any Study Data, and submissions of manuscripts for review (as such capitalized terms are defined in the SWOG Agreement) and (y) in reference to the NCI Agreement, regulatory reporting matters, submissions of manuscripts for review and notice of patent matters), CPP shall promptly notify One-Two of such matters and shall comply with One-Two’s instructions regarding responses thereto or further actions in respect thereof (so long as such responses or further actions are consistent with the terms of the PACES Agreements). One-Two acknowledges that its rights to Study Data generated in the performance of the PACES Trial, as set out in Article 4, are subject to the applicable terms of each of the PACES Agreements, none of which would reasonably be expected to affect any of One-Two’s or its Sublicensee’s rights to Study Data. Prior to the assignment of the PACES Agreements to One-Two, One-Two agrees to use commercially reasonable efforts to support the Development activities related to the PACES Trial as set out in the PACES Agreements, through the conclusion of the PACES Trial. For greater certainty, One-Two is not responsible for, and will not assume, any obligation of CPP under the PACES Agreements or PACES Trial arising from or related to CPP’s acts or omissions before the Effective Date.

2.3      Excluded Studies. Except pursuant to the Right of Reference granted to One- Two in accordance with Section 4.3(a), One-Two shall have no rights with respect to CPP’s Development activities, Study Data or results for products other than the Product (each such Development activity that is a clinical study, an “Excluded Study” and all such Study Data or results obtained therefrom, “Excluded Data”), including (a) any Study Data generated in the performance of a clinical study under IND 107 or IND 140, or (b) any Regulatory Approvals obtained on the basis of clinical studies conducted under IND 107 or IND 140, including any Excluded Study.

2.4       Services Agreement. From the Effective Date until December 31, 2021, and at no charge to One-Two or its Affiliates, One-Two and its Affiliates shall have reasonable access to CPP personnel (including consultants and/or part-time personnel) for any purpose reasonably necessary with respect to the Product in the Territory, but expected to primarily be related to clinical development, regulatory affairs, and supply chain services with respect to the Product in the Territory. On or before the Effective Date and as a condition to One-Two entering into this Agreement and paying the Upfront Amount, the following CPP employees must have must have entered into noncompetition and non-solicitation restrictive covenants agreement(s) with One- Two, in the form attached as Exhibit C: Elizabeth Bruckheimer, Jeffrey Jacob, and Ashok Chavan. During the Term, CPP shall not terminate, waive any rights, fail to enforce, or amend any existing noncompetition and/or non-solicitation agreement(s) in any manner that would be adverse to One-Two’s rights in the Territory under this Agreement. Subject to Section 5.3 and the other provisions of this Agreement and expect as provided in the noncompetition and non- solicitation restrictive covenants agreements referenced in this Section 2.4, One-Two acknowledges that CPP and its employees, officers, and directors may work (i) on any product in any Field outside of the Territory and (ii) on Products in the Territory solely to support CPP’s Development and Commercialization outside the Territory or to provide services to or for the benefit of One-Two, its Affiliates and Sublicensees regarding the Products under and in accordance with this Agreement and the other Transaction Documents. If One-Two desires to obtain additional similar CPP services with respect to the Product in the Territory after December 31, 2021, One-Two shall notify CPP of such services and the Parties will negotiate in good faith to enter into a services agreement (“Services Agreement”) for CPP to provide such services to One-Two at an agreed upon CPP FTE rate.

Article 3

Regulatory and Supply

3.1       General. To the extent not already provided, CPP promptly shall provide to One- Two complete copies of Regulatory Filings regarding the Products in the Territory. During the Term, to the extent permitted by applicable Law, each Party shall provide the other Party with access to or copies of all material written or material electronic correspondence from Regulatory Authorities with regard to Regulatory Filings relating to the Development or Commercialization of Products received by such Party. Each Party shall use commercially reasonable efforts to cooperate with the other Party in order for such other Party to seek, obtain and maintain Regulatory Approval of the Product in such other Party’s respective territory.

3.2       NDA Ownership, IND Ownership, Trial Sponsorship. Transfer of ownership to the CPP NDA, IND 103, and regulatory filings relating to the Products, and all data, documents, and submissions relating thereto, will only be filed by One-Two following its payment of the Initial Upfront Payment and the Initial Sanofi Payment (i.e., on or after the Payment Date) in accordance with Section 9.1. On or before the Effective Date, CPP shall deliver to One-Two letters addressed to the FDA notifying the FDA of the transfer of ownership of (a) the CPP NDA and (b) IND 103 to One-Two, effective as of the Effective Date, and authorizing One-Two to file such transfer letters on behalf of CPP, and CPP shall promptly deliver to One-Two such other instruments and documents as may be necessary for One-Two to effect and record with the FDA the transfer to One-Two of such CPP NDA, IND 103, or regulatory filing relating to the Products, and all data, documents, and submissions relating thereto. One-Two and CPP shall coordinate in executing and filing with the FDA the documents necessary to evidence such transfer, including documentation from CPP stating that all rights to the CPP NDA and IND 103 have been transferred to One-Two, and documentation from One- Two stating that One-Two has assumed the obligations under the CPP NDA and IND 103 and is committing to the agreements and conditions contained in the CPP NDA and IND 103. One- Two and CPP shall, within two (2) Business Days (unless otherwise mutually agreed by the Parties) after the Payment Date, have filed, or caused to be filed, through the electronic gateway, all necessary documentation related to such transfers with the FDA or other Regulatory Authority. Promptly after the Payment Date, CPP will exercise its rights to secure all required consents in order to assign the PACES Agreements to One-Two.

(i)       After the Effective Date, One-Two will have sole control and responsibility for obtaining Regulatory Approval for the Product in each country of the Territory (including regulatory strategy, clinical strategy and operations) and all other activities for securing and maintaining Regulatory Approval for the Product in the Territory. Such efforts may or may not include any current or planned strategies advocated by CPP to obtain FDA approval for the Product in the U.S. by end of Q1 2022 under the CPP NDA by filing over protest (the “CPP Plan”), including discontinuing the CPP Plan at any time and at One-Two’s discretion. One-Two will hold all Regulatory Filings for the Product in the Territory.

(ii)     After the Effective Date, (A) One-Two shall have the sole right and authority, at its sole cost and expense, to prepare all Regulatory Filings for and seek (or subject to Article 6, elect not to seek) to obtain and maintain Regulatory Approvals for the Products in the Field in the Territory and to conduct all related regulatory matters, including communications with any Regulatory Authorities relating to the Products in the Territory and (B) during the Term, CPP shall have no right to attend or participate, nor shall it attend or participate, in any meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority relating to a Product in the Territory, without One-Two’s prior written consent. After the Effective Date, CPP shall have no right to review and comment on any regulatory correspondence and Regulatory Filings relating to the Product in the Territory, but consistent with Section 3.1, One-Two shall forward to CPP any regulatory correspondence related to the Product in the Territory that it receives after the Effective Date.

(iii)    Until such time as the transfer of ownership of CPP’s IND 103 and the CPP NDA to One-Two are effected, CPP (as One-Two’s designee) will at One-Two’s express direction, and consistent with directions provided by One-Two: (i) make all required Regulatory Filings, submissions, reports, updates and supplements with any Regulatory Authority with respect to the Product in the Territory; and (ii) hold and maintain all Regulatory Approvals and Pricing Approvals in the Field in the Territory in the name of CPP.

(b)       Fast Track and Orphan Designation. CPP represents and warrants to One-Two that the FAP Product has received fast track designation for the FAP Indication in accordance with Section 506(b) of the Food, Drug & Cosmetic Act providing for expedited review of Regulatory Filings. After the Effective Date, One-Two shall have the sole and exclusive right to submit Regulatory Filings related to such fast track designation on its behalf. CPP represents and warrants to One-Two that the FAP Product has received orphan designation for treatment of familial adenomatous polyposis in accordance with Section 526(a) of the Food, Drug & Cosmetic Act. As of the Effective Date, in connection with its designation of One-Two as the new sponsor of the PACES Trial and owner of the IND 103 and the CPP NDA, CPP shall transfer and assign its entire beneficial interest in the orphan drug designation of the FAP Product to One-Two. On or before the Effective Date, CPP shall deliver to One-Two an executed letter addressed to the FDA notifying the FDA of the transfer of ownership orphan drug designation to One-Two, effective as of the Effective Date. On or after the Payment Date, One- Two will file with FDA the executed letter provided by CPP and its acceptance of such assignment necessary to evidence such transfer and assignment required (as the former owner or assignee or the new owner or assignee, as applicable) under 21 C.F.R. §316.27(a) in respect of such transfer. One-Two and CPP shall, within two (2) Business Days (unless otherwise mutually agreed by the Parties) after the Payment Date, have filed, or caused to be filed, through the electronic gateway, all necessary documentation related to such transfer with the FDA or other Regulatory Authority. Nothing in this Agreement shall be construed to preclude CPP from claiming the credit under Section 45C of the Code with respect to expenses incurred in connection with development of the FAP Product prior to the Effective Date and, for the avoidance of doubt, the right to claim such credits related to expenses incurred in the development of the FAP Product prior to the Effective Date is not being transferred to One-Two hereunder. Accordingly, One-Two shall not seek to claim any such credit for such period prior to the Effective Date for its own account. CPP shall not claim such credit for expenses incurred after the Effective Date. Nothing in this Agreement shall be construed to preclude One-Two from claiming such credit for expenses incurred after the Effective Date.

3.4       Pharmacovigilance Agreement. Not later than 120 days following the Effective Date, the Parties shall negotiate in good faith and enter into a written pharmacovigilance agreement on reasonable and customary terms that will provide for pharmacovigilance activities related to the Products such that CPP shall be able to comply with CPP’s global reporting obligations for the Products outside of the Territory and One-Two shall be able to comply with One-Two’s reporting obligations for the Products in the Territory (“Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall include the responsibilities and obligations of the Parties with respect to reporting procedures, timeframes for compliance with all applicable Laws pertaining to safety reporting and their related activities, to set forth the protocols and procedures for reporting adverse events and complying with reporting requirements set forth by Regulatory Authorities, and the transfer of historical safety data, in each case consistent with the Parties rights, responsibilities, duties and obligations under this Agreement. Under the terms of the Pharmacovigilance Agreement, CPP shall report adverse events in a manner to permit One-Two to fulfill its pharmacovigilance-related obligations under applicable Law in the Territory, and One-Two shall report adverse events in a manner to permit CPP to fulfill its pharmacovigilance-related obligations under applicable Law outside of the Territory; provided that until such Pharmacovigilance Agreement is entered into between the Parties, each Party shall promptly notify the other Party of any such adverse events regarding a Product. As between the Parties, CPP shall establish and maintain the global safety database for the collection and maintenance of all individual case safety report data for Product. CPP shall establish and maintain such safety data in a manner to permit One-Two to fulfill its pharmacovigilance-related obligations under applicable Law in the Territory.

3.5       Quality Agreements. The Parties agree to negotiate and enter into such quality agreements as may be necessary or appropriate to permit the Parties to comply with their respective obligations under applicable Laws, including compliance with good clinical practice and good manufacturing practice, as applicable.

3.6      Contractors. Subject to the terms and conditions of this Agreement, One-Two shall have the right to engage Contractors for purposes of conducting Development, Manufacture or Commercialization activities hereunder. Other than with respect to the conduct of CPP under the Services Agreement or any other activities performed by CPP or any of its Affiliates in connection with the Development, Manufacture or Commercialization activities hereunder, One- Two shall be and remain liable for the conduct of each such Contractor with respect to any One- Two obligations hereunder that are delegated or subcontracted to such Contractor as if such conduct were that of One-Two itself.

(a)       Cooperation; Amendment. Following the Effective Date, CPP shall cooperate with One-Two to facilitate One-Two entering into an agreement with Sanofi to supply One-Two with its requirements of Product for Development and Commercialization in the Territory on pricing and terms that are no less favorable to One-Two as the pricing and terms under which CPP acquires the Product; provided that if One-Two is unable to negotiate such pricing and terms with Sanofi, such negotiations shall not be deemed a breach by CPP of this Agreement, subject to CPP’s compliance with its obligations under this Section 3.7(a). Once Sanofi and One-Two have entered into such supply agreement, CPP will use commonly reasonable efforts to amend the Sanofi Commercial Supply Agreement with Sanofi such that Sanofi would not, during the Term, manufacture the Product for CPP, any of its Affiliates or their respective (sub)licensees for Development and Commercialization of the Product in the Territory.

(b)        Supply Obligation. Until such an agreement between Sanofi and One- Two is executed, CPP shall, upon One-Two’s written requests, exercise CPP’s rights under the Sanofi Commercial Supply Agreement, to supply One-Two with its requirements of Product for Development and Commercialization in the Territory on substantially the same terms under which CPP acquires the Product, including the price (i.e., payments due Sanofi for such orders will be made via a pass-through from One-Two to CPP to Sanofi, with no mark-up). One-Two shall deliver to CPP forecasts (binding and non-binding) and purchase orders in sufficient time for CPP to exercise such rights. CPP agrees to exercise its rights to enable One-Two to benefit from all applicable warranties, guarantees and indemnities from Sanofi in the Sanofi Commercial Supply Agreement. With respect to the Product in the Territory delivered by CPP or Sanofi pursuant to this Section 3.7(b) after the Effective Date, One-Two will be responsible for all payments due Sanofi under the Sanofi Commercial Supply Agreement (and such other related ancillary agreements between CPP and Sanofi) to support Development and Commercialization of the Products in the Territory, which shall include pre-commercial supply of such Product requested by One-Two, research and development expenses under such Sanofi Commercial Supply Agreement (and such other related ancillary agreements between CPP and Sanofi) and other ancillary costs and expenses related to such Sanofi Commercial Supply Agreement (and such other related ancillary agreements between CPP and Sanofi) in furtherance of One-Two’s Development and Commercialization of the Products in the Territory (the “One-Two Supply Payments”). CPP’s obligation under this Section 3.7(b) to supply Product shall expire (and One- Two’s obligation to make One-Two Supply Payments for any period after such expiration shall terminate) on the earlier of: (i) the date on which One-Two obtains its own supply of Product from Sanofi pursuant to its own commercial supply agreement; (ii) the date that is two (2) years after any manufacturing exclusivity obligations under the Sanofi Commercial Supply Agreement expire according to their terms or are terminated or (iii) the expiration of the Royalty Term in each country of the Territory.

Article 4

Study Data; Rights of Reference; Data License

(a)       FAP Pivotal Trial and PACES Trial Study Data. To the extent not provided by CPP to One-Two (including via its Affiliates) prior to the Effective Date, CPP shall as promptly as practicable provide to One-Two copies of or access to all Study Data made, collected or otherwise generated in connection with the FAP Pivotal Trial or the PACES Trial (the “FAP/PACES Trial Study Data”), to the extent such FAP/PACES Trial Study Data is Controlled by CPP or any of its Affiliates. Such delivery shall include a Data Package for each of the FAP Pivotal Trial and the PACES Trial, in electronic format or such other format as One- Two may reasonably request. Any Study Data generated in connection with CPP’s performance of services under this Agreement or the Services Agreement shall be delivered as set forth in therein. Notwithstanding any transfer of the PACES Agreements, CPP NDA and IND 103 to One-Two in accordance with Section 3.1, nor any other provision of this Agreement or the Services Agreement to the contrary, as between the Parties, CPP shall solely own the FAP/PACES Trial Study Data, subject to the rights granted to One-Two in accordance with Sections 4.2(a) and 4.3.

(b)       Future Study Data. The Parties anticipate that in exercising the rights licensed to One-Two in the Territory under Section 5.1, One-Two or its Affiliates or Sublicensees may perform (or have performed on its behalf) clinical studies with respect to FAP Product, including under IND 103 (after ownership thereof is transferred to One-Two) (“One- Two Studies”) and that Study Data may be generated in the performance of such One-Two Studies (all such Study Data that is Controlled by One-Two or its Affiliates, “One-Two Study Data”). For clarity, all Study Data made, collected or otherwise generated in connection with the PACES Trial, to the extent such Study Data is Controlled by CPP or any of its Affiliates, shall be and remain FAP/PACES Trial Study Data. One-Two shall provide CPP with One-Two Study Data pursuant to its obligations under this Agreement (including Article 7), as required by applicable Law in the Territory and as otherwise mutually agreed by the Parties. One-Two will use commercially reasonable efforts to provide One-Two Study Data to CPP that is reasonably requested by CPP solely to support its Regulatory Filings for the FAP Product in the Field outside the Territory. CPP acknowledges that One-Two Study Data is Confidential Information.

(a)       Subject to the terms and conditions of this Agreement, and subject to CPP’s rights and obligations assigned to One-Two under the PACES Agreements in accordance with this Agreement, CPP hereby grants to One-Two, and One-Two hereby accepts, an exclusive, sublicensable, fully paid-up, royalty-free, license to reference and use the FAP/PACES Trial Study Data to support Regulatory Filings and Regulatory Approvals of One- Two, its Affiliates and Sublicensees for the Product in the Field in the Territory, including in connection with Manufacturing, Development and Commercialization activities in connection therewith, and to otherwise support Commercialization and further Development of the Product in the Field in the Territory. CPP acknowledges and agrees that One-Two’s rights to use FAP/PACES Trial Study Data shall include, subject to the PACES Agreements, rights to publish or support publication of the FAP/PACES Trial Study Data for scientific and research purposes, as deemed appropriate by One-Two in accordance with its internal processes, procedures and guidelines for such publications. For clarity: (a) to the extent any FAP/PACES Trial Study Data is within the scope of the Licensed Know-How, the rights granted under Section 5.1(a) shall also apply and (b) CPP shall retain the right to use and disclose FAP/PACES Trial Study Data in Regulatory Filings submitted by or on behalf of CPP and its sublicensees outside of the Territory.

(b)       One-Two hereby grants to CPP, and CPP hereby accepts, an exclusive, sublicensable, fully paid-up, royalty-free, license to reference and use the One-Two Study Data to support Regulatory Filings and Regulatory Approvals of CPP, its Affiliates and licensees for the FAP Product in the Field outside of the Territory. Each of One-Two and CPP acknowledges and agrees that CPP’s rights to use One-Two Study Data shall not include, rights to publish or support publication of the One-Two Study Data for scientific and research purposes.

(a)       One-Two Grant to CPP. Subject to the terms and conditions of this Agreement, One-Two hereby grants CPP a Right of Reference to each Regulatory Filing for each One-Two Study, including (i) IND 103, (ii) each other IND under which a One-Two Study is performed, (iii) the CPP NDA and (iv) each Regulatory Approval of the FAP Product that is obtained by or on behalf of One-Two or its Affiliates or Sublicensees using One-Two Study Data, to support Regulatory Filings and Regulatory Approvals of CPP, its Affiliates and licensees for the FAP Products in the Field outside of the Territory, including in connection with Manufacturing, Development and Commercialization activities in connection therewith.

(b)       CPP Grant to One-Two. Subject to the terms and conditions of this Agreement, CPP hereby grants One-Two an exclusive Right of Reference to (i) IND 103 and (ii) the CPP NDA (in each case prior to their assignment to One-Two in accordance with this Agreement), and (iii) each Regulatory Approval of the Product that is obtained by or on behalf of CPP or its Affiliates or licensees using FAP/PACES Trial Study Data to support Regulatory Filings and Regulatory Approvals of One-Two, its Affiliates and Sublicensees for the Product in the Field in the Territory, including in connection with Manufacturing, Development and Commercialization activities in connection therewith.

(c)        Regulatory Authority Access; Cross-Reference Letter.

(i)      One-Two shall allow applicable Regulatory Authorities in a country outside of the Territory to have access to information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Filings for One-Two Studies to the extent necessary to effectuate the Rights of Reference described above in Section 4.3(a) no later than thirty (30) days after written request by CPP (or, if later, as soon as reasonably practicable). One-Two shall provide CPP with a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the Right of Reference.

(ii)    Subject to CPP’s rights and obligations under the PACES Agreements, CPP shall allow applicable Regulatory Authorities in a country inside the Territory to have access to information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Filings for (A) the FAP Pivotal Trial and (B) the PACES Trial, in each case to the extent necessary to effectuate the Rights of Reference described above in Section 4.3(b) no later than thirty (30) days after written request by One-Two. CPP shall provide One- Two with a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the Right of Reference.

Article 5

Intellectual Property License Grants

(i)      Exclusive Development and Commercialization License in the Territory. Subject to the terms and conditions of this Agreement and effective upon the Effective Date, CPP hereby grants to One-Two an exclusive license, with the right to sublicense in accordance with Section 5.1(c), under the Licensed IP (other than the Licensed Marks, which are licensed pursuant to Section 8.3 below) to Develop, Commercialize, import, offer for sale and sell the Product in the Field solely in the Territory; provided, however, that: (A) if (1) One- Two or its Affiliates or Sublicensees wish to establish clinical trials sites outside the Territory in order to conduct a clinical trial of the Product solely for purposes of Development of the Product in the Territory or (2) CPP, its Affiliates or licensees wish to establish clinical trials sites within the Territory in order to conduct a clinical trial of the Product solely for purposes of Development of the Product outside of the Territory, then the Parties shall discuss in good faith; and (B) CPP shall retain the right to (1) import Product into the Territory for the purpose of fulfilling its obligations to supply Product to One-Two in accordance with Section 3.7, and (2) if applicable, exercise its rights to comply with its obligations under Section 2.2(b) with respect to the PACES Trial or its obligations under the Services Agreement.

(ii)     Non-Exclusive Manufacturing License. Subject to the terms and conditions of this Agreement and effective upon the Effective Date, including Section 5.1(b), CPP hereby grants to One-Two a non-exclusive license, with the right to sublicense in accordance with Section 5.1(c), under the Licensed IP (other than the Licensed Marks) to Manufacture and have Manufactured the Product in the Field anywhere in the world, in each case solely to Develop or Commercialize the Product in the Territory pursuant to Section 5.1(a)(i).

(i)     Notwithstanding the license granted to One-Two under Section 5.1(a)(ii) above to Manufacture and have Manufactured the Product in the Field in the Territory, the Parties acknowledge and agree that, as of the Effective Date: (A) CPP is subject to certain legally binding exclusivity obligations pursuant to that certain Amended and Restated Manufacturing, Packaging and Supply Agreement, dated December 1, 2019, by and between CPP and Sanofi Winthrop Industrie (the “Sanofi Commercial Supply Agreement”), under which Sanofi is granted the right to be the exclusive source of the Product. One-Two acknowledges and agrees that, prior to One-Two entering into a commercial supply agreement with Sanofi (but no later than the remaining term of the Sanofi Commercial Supply Agreement, as in effect on the Effective Date) One-Two shall have no right to Manufacture or have Manufactured Product in any manner that would breach or would cause CPP to breach the Sanofi Commercial Supply Agreement, as in effect on the Effective Date and previously provided to One-Two.

(ii)     Although the license under Section 5.1(a)(ii) is non-exclusive, from and after the Effective Date, CPP’s rights to Manufacture Product or have Product Manufactured in the Territory shall be limited to the following: (A) to grant rights to Sanofi and to otherwise perform its obligations under the Sanofi Commercial Supply Agreement, provided such performance does not and is not reasonably expected to result in the supply of the Product in the Territory to any Person other than One-Two, its Affiliates and Sublicensees, (B) to Manufacture or have Product Manufactured that will be used solely for purposes of Development or Commercialization of the Product outside of the Territory or as otherwise permitted in accordance with Section 5.1(a).

(c)       Sublicense Rights. One-Two may grant sublicenses of the licenses granted to One-Two under Section 5.1(a) through multiple tiers, to any Affiliate or Third Party solely in accordance with this Section 5.1(c). If a sublicense by One-Two pursuant to commercially reasonable terms would not result in One-Two earning a reasonable profit from such sublicense for any calendar year during the proposed sublicense term because of One-Two’s royalty obligation at the rate of [*****] of Net Sales under Section 9.3, then the Parties shall negotiate in good faith to reduce One-Two’s royalty obligation to CPP under Section 9.3 with respect to sales of the Products by such sublicensee to allow for a sublicense on commercially reasonable terms One-Two to generate a reasonable profit from such sublicense. One-Two shall: (i) include in each sublicense agreement terms that permit One-Two to comply with its obligations under this Agreement, including related to reporting the Net Sales royalties and One-Two Sublicensing Fixed Payments received from such Sublicensee to CPP; (ii) notify CPP of such sublicense or amendment thereto within thirty (30) days after it becomes effective, including the identity of the Sublicensee and the territory in which such rights have been sublicensed; (iii) at CPP’s request, subject to compliance with confidentiality obligations under such sublicense agreement, provide CPP a copy of such sublicense agreement and amendment thereto, provided that One-Two may redact financial terms not relevant to CPP’s rights under this Agreement; and (iv) use commercially reasonable efforts to enforce the terms of such sublicense agreement. Each sublicense of One-Two’s rights under this Agreement shall be in writing, shall be consistent with the terms and conditions of this Agreement, and shall require the Sublicensee, in granting any further sublicenses, to comply with One-Two’s obligations under this Section 5.1(c) as though such Sublicensee were One-Two.

(d)       Expiration. Upon expiration (but not earlier termination) of the Royalty Term, on a Product-by-Product and country-by-country basis in the Territory, the licenses granted to One-Two by CPP under Section 5.1(a) shall become fully paid-up, royalty-free, irrevocable and perpetual licenses in the Field with respect to such applicable Product and such applicable country in the Territory.

(e)       Negative Covenant. One-Two shall not use any Licensed IP for any purposes other than those purposes expressly permitted in Section 5.1 or as otherwise expressly permitted in this Agreement. For clarity, One-Two shall not Develop or Commercialize the Product outside of the Territory and shall not enable or support any Affiliate or Third Party to Commercialize the Product outside of the Territory.

(a)       One-Two acknowledges and agrees that certain of the rights licensed by CPP to One-Two under this Agreement are subject to CPP’s rights and obligations under that particular Amended and Restated Exclusive License Agreement between the Arizona Board of Regents on behalf of the University of Arizona (“University of Arizona”) and CPP dated December 19, 2013, as amended (“Arizona License Agreement”). One-Two agrees to be bound and subject to all applicable provisions described in the Arizona License Agreement, including Sections 2.2 (with respect to any sublicenses granted by One-Two), 2.3, 2.4, 3, 5.1, 11, and 12 of the Arizona License Agreement. Pursuant to the Arizona License Agreement, University of Arizona may use, solely for educational and internal research purposes, that portion of the Licensed Patents and Licensed Know-How that University of Arizona licensed to CPP, together with the right to sublicense such rights to another institution of higher education only if one of the inventors of such Licensed Patents or Licensed Know-How moves to such other institution.

(b)       CPP shall comply with all obligations under the Arizona License Agreement and shall not exercise its right to terminate the Arizona License Agreement, such that the Arizona License Agreement remains in full force and effect during the Term of this Agreement or, if applicable, until the earlier termination or expiration of CPP’s obligations under the Arizona License Agreement. CPP shall be solely responsible for CPP’s timely payment of all Arizona Payment Obligations in accordance with the terms of the Arizona License Agreement and, upon One-Two’s reasonable written request, shall provide reasonable verification of such payments. In the event CPP fails to timely make any Arizona Payment Obligation in accordance with the terms of the Arizona License Agreement or to otherwise comply with its obligations under the Arizona License Agreement, then in addition to any other remedies One-Two may have under this Agreement in respect of such failure, (i) One-Two may satisfy such Arizona Payment Obligation or perform such other obligations, (ii) upon One-Two’s request, CPP shall use commercially reasonable efforts to cause University of Arizona to accept such payment or such performance from One-Two described in clause (i) above in satisfaction of CPP’s obligations under the Arizona License Agreement, (iii) CPP shall promptly reimburse One-Two for any such amounts as described in clause (i) above paid by One-Two in respect of the Arizona License Agreement or paid by One-Two to Third Parties in the course of such performance, together with interest on such amount at the rate set forth in Section 9.6(e) and (iv) One-Two may offset any unreimbursed amounts from any amounts due from One-Two under this Agreement. CPP shall notify One-Two immediately if any of the events described in Section 7.4 of the Arizona License Agreement occur or are likely to occur, and, in addition to facilitating the assignment of the sublicense of CPP’s license under the Arizona License Agreement to One-Two pursuant to Section 7.6 of the Arizona License Agreement, CPP shall take such steps as One- Two may reasonably request to ensure One-Two’s continued right and license to use that portion of the Licensed IP that is licensed by CPP under the Arizona License Agreement in the Field in the Territory during the Term.

(i)      During the Term, and other than in connection with its obligations under this Agreement or its provision of services under the Services Agreement, CPP shall not, directly or indirectly, Develop or Commercialize in the Territory (or license to any Person who will develop or commercialize in the Territory) (a) any product with a formulation containing both Active Ingredients for use in the Field or (b) any product for the treatment or prevention of FAP.

(ii)      During the Term, One-Two shall not, directly or indirectly, Develop or Commercialize in the Territory any product for the treatment or prevention of FAP, except pursuant to this Agreement.

(i)      Notwithstanding Section 5.3(a), if either Party undergoes a Change of Control and, on the date of the closing of such Change of Control, the Acquiring Person is Developing, Manufacturing, or Commercializing a Competing Program, then the Acquiring Person shall not be in breach of Section 5.3(a) (and shall not be restricted by Section 5.3(a) on a going forward basis) as a result of such Development, Manufacture, or Commercialization of such Competing Program; provided, that such Acquiring Person: (i) provides written notice to the Party not undergoing the Change of Control no later than sixty (60) days following the closing of such Change of Control which identifies such Competing Program; and (ii) from and after the closing of such Change of Control Segregates such Competing Program.

(ii)      As used in this Section 5.3(b),

(1)    “Acquiring Person” means, collectively, the Third Party referenced in the definition of Change of Control and such Third Party’s Affiliates, other than the Acquired Person in the definition of Change of Control and such Acquired Person’s Affiliates, determined immediately prior to the closing of such Change of Control.

(2)     “Competing Program” means any activities conducted by an Acquiring Person immediately prior to a Change of Control which, if conducted by a Party or its Affiliates, would constitute a breach of the exclusivity provisions contained in Section 5.3(a).

(3)    “Segregate” means, with respect to a Competing Program, to segregate the Development, Manufacture, and Commercialization activities relating to such Competing Program from the Development, Manufacture, or Commercialization activities with respect to the Products under this Agreement, including ensuring that: (A) no personnel involved in performing the Development of such Competing Program have access to non-public plans or non-public information relating to the Development, Manufacture, or Commercialization of Products or any other relevant Confidential Information of the applicable Party; and (B) no personnel involved in performing the Development, Manufacture, or Commercialization of Products have access to non-public plans or non-public information relating to the Development, Manufacture, or Commercialization of such Competing Program; provided, that, in either case (clauses (A) or (B)), senior management personnel may review and evaluate plans and information regarding the Development, Manufacture, or Commercialization of such Competing Program solely in connection with monitoring the progress of products including portfolio decision-making among product opportunities.

5.5      No Implied Rights; Right to Perform. Except as expressly provided in Sections 5.1 and 8.3, no rights to any Patents, Know-How, or other intellectual property rights are granted to One-Two under this Agreement, whether by implication, estoppel, or otherwise, provided that each Party shall have the right to perform its obligations under this Agreement and the Services Agreement.

Article 6

Diligence, Regulatory Approval, Commercialization Efforts

6.1        One-Two shall use Commercially Reasonable Efforts to Develop and Commercialize the FAP Product in the United States for use in connection with the treatment or prevention of FAP. One-Two shall use Commercially Reasonable Efforts to seek, obtain and maintain Regulatory Approval for the FAP Product in the United States. In reference to seeking Regulatory Approval and Commercialization of the FAP Product, “Commercially Reasonable Efforts” shall mean those efforts that a pharmaceutical business of comparable size and resources to One-Two and its Affiliates (the “Commercialization Affiliates”) would reasonably employ to market, sell and promote a similar product owned by it or to which it has exclusive rights which is of similar market potential at a similar stage in its development or product life taking into account all relevant circumstances, including (a) patent coverage, safety and efficacy, and product profile, (b) the historical sales trends of the product (if any) and competitiveness in the marketplace, (c) the regulatory and legal structures involved, (d) the size of the possible patient population for the product in the applicable territory given its authorized uses, (e) the promotion sensitivity of the product and the relative level of clinical acceptance of the product, (f) the nature, size and resources of any competition to the product and the relative differentiation of the product versus any competitive offerings, (g) the relative difficulties associated with achieving insurance and other payor coverage for the product, (h) the relative difficulties associated with achieving formulary acceptance for the product, (i) the resources available to the Commercialization Affiliates to market and sell the Product, including through the sales force of the Commercialization Affiliates, (j) the adverse event profile of the product, and (k) the pricing and reimbursement dynamics associated with the product. As part of its Commercially Reasonable Efforts to Commercialize the FAP Product in the United States, One-Two does not guaranty or covenant to CPP that it or its Commercialization Affiliates will commit any particular number of salespeople or incur any particular level of spending in any given period of time relative to the Development and Commercialization of the FAP Product in the United States. One-Two will use Commercially Reasonable Efforts to provide compensation and incentives to sales representatives it engages to Commercialize the FAP Product in the locations for which Commercialization of the FAP Product is authorized by One-Two in amounts commensurate with products of similar size and potential; provided that One-Two shall comply in all material respects with all applicable Law with respect to such compensation and incentives.

6.2        During the Term, if One-Two determines in its sole judgment that it is not commercially reasonable to Develop or seek or obtain Regulatory Approval for the FAP Product in the United States, One-Two shall notify CPP of such decision within five (5) Business Days. For clarity, such a determination shall not be a breach of One-Two’s obligation to use Commercially Reasonable Efforts to Develop and seek and obtain Commercialize Regulatory Approval for the FAP Product in the United States in accordance with Section 6.1. Upon such notification from One-Two, CPP may terminate the Agreement with respect to the FAP Product in the United States pursuant to Section 14.2(b).

Article 7

Material Developments

The Parties will promptly share information regarding material Development, regulatory, and Commercialization activities with respect to the FAP Product. Once every year during the Term, each Party will provide the other Party with a summary of any material developments with its Development and Commercialization of the FAP Product, and meet with a representative of the other Party for an update on the Development, regulatory, and Commercialization activities with respect to the FAP Product.

Article 8

Commercialization

8.1        Generally. One-Two (on its own or acting through or together with any of its Affiliates, Sublicensees or Contractors) has the sole right and responsibility to Commercialize the Product in the Field in the Territory at its sole cost and expense (except as expressly provided in this Agreement). One-Two shall have the sole right and authority, at its sole cost and expense, to promote the Product in the Field in the Territory. As between the Parties, CPP has the sole right and responsibility to Commercialize the Product in the Field outside the Territory at its sole cost and expense. CPP shall have the sole right and authority, at its sole cost and expense, to promote the Product in the Field outside the Territory.

8.2        Conduct and Coordination of Commercialization Activities. To the extent One-Two engages any Affiliates, Sublicensees or Contractors to participate in Commercialization, One-Two shall and shall cause its Affiliates, Sublicensees and Contractors to conduct all Commercialization in accordance with the terms and conditions of this Agreement and in compliance with applicable Law.

(a)    Trademark License. Subject to the terms and conditions of this Agreement, CPP hereby grants to One-Two, during the term of this Agreement, an exclusive, royalty-free license to reproduce, use and display the Licensed Marks solely to (i) Commercialize the FAP Product in the Field and (ii) Manufacture and have Manufactured the Product in the Field anywhere in the world, in each case solely to Commercialize the Product in the Territory pursuant to Section 5.1(a)(i). All representations of the Licensed Mark(s) that One- Two intends to use, if not previously approved by CPP, will first be submitted to CPP for approval, such approval not to be unreasonably withheld, conditioned or delayed. All goodwill accruing from the use of any Licensed Marks shall inure solely to the benefit of CPP.

(b)    Ownership. One-Two acknowledges that the Licensed Marks are owned by CPP. The Licensed Marks shall be and remain the sole and exclusive property of CPP. One- Two agrees, at the reasonable request of CPP, to execute any and all proper documents appropriate to assist CPP in obtaining and maintaining CPP’s rights in and to the Licensed Marks.

(c)    Products. During the Term, One-Two shall have the right, but shall not be obligated, to Commercialize the FAP Product in the Territory under the Licensed Marks. To the extent One-Two determines to utilize the Licensed Marks for the FAP Product, all packaging materials, package inserts, labels, labeling, and marketing, sales, advertising and promotional materials relating to the FAP Products distributed by One-Two under this Agreement shall bear the Licensed Marks together with a notice that the such marks are used under license from CPP, subject to the approval of such labeling by appropriate Governmental Authorities. Prior to First Commercial Sale, One-Two shall submit to CPP, for prior approval, which, if such consistent with CPP’s standards of quality, shall not be unreasonably withheld, conditioned or delayed, all materials bearing the Licensed Marks that One-Two intends to use with respect to Licensed Products (such approved materials, the “Approved Materials”). Following approval, One-Two may continue to use the Licensed Marks in a manner materially consistent with such approval and any subsequent approval by CPP shall only be required if material changes are made to the Approved Materials. Upon reasonable request, One-Two shall provide CPP with samples of such use.

Article 9

Financial Provisions

9.1        Upfront Amount. In partial consideration of the license and rights granted by CPP to One-Two under this Agreement, subject to this Section 9.1, One-Two shall pay an amount equal to $5 Million Dollars (the “Upfront Amount”), subject to and in accordance with this Section 9.1. The Upfront Amount that is payable on the Payment Date is non-refundable and non-creditable against any other payments due hereunder, but shall be taken into account in determining the amount of other payments due under this Agreement. One-Two will pay, by wire transfers of immediately available funds, [*****] Dollars (the “Effective Date Payment”) of the Upfront Amount on or within two (2) Business Days after the Effective Date as follows: (a) to CPP $2,202,800 Dollars (“Initial Upfront Payment”) in accordance with the wire instructions provided by CPP in writing to One-Two prior to the Effective Date and (b) to Sanofi-Aventis (or any of its Affiliates) €1,113,718 Euros (on behalf of CPP (the “Initial Sanofi Payment”) in accordance with the wire instructions provided by CPP in writing to One-Two prior to the Effective Date. The remaining $1,460,739 Dollars of the Upfront Amount will be retained by One-Two and subsequently paid to Sanofi-Aventis (or any of its Affiliates) after the Effective Date, in accordance with the anticipated payment schedule set forth on Schedule 9.1 and pursuant to the payment instructions provided to One-Two prior to the payment (or such other payment instructions provided by Sanofi to One-Two), on behalf of CPP for CPP’s obligations arising under the Sanofi Commercial Supply Agreement. CPP will provide One-Two with prompt notice and detailed calculations of all amounts due to Sanofi-Aventis (or any of its Affiliates) under the Sanofi Commercial Supply Agreement or any ancillary or related agreement(s) thereto pursuant to this Section 9.1 or Section 3.7(b), in each case related to Manufacturing the Products. The aggregate payments to Sanofi-Aventis (or any of its Affiliates) by One-Two on behalf of CPP (whether or not such payment obligations are identified by CPP) are referred to as the “Sanofi Required Payments.” The date on which the Initial Upfront Payment and Initial Sanofi Payment are paid by One-Two in accordance with the payment instructions provided by CPP to One-Two before the Effective Date is referred to in this Agreement as the “Payment Date.” Notwithstanding anything to the contrary in this Agreement, One-Two is not in any way responsible for or liable in connection with any aspect of the calculation of the amount of the Initial Sanofi Payment or any other Sanofi Required Payments or any failure of CPP or Sanofi to receive the Initial Upfront Payment or Initial Sanofi Payment, other than as a result of One-Two not sending by wire transfer of immediately available funds such payments in accordance with the wire instructions provided by CPP to One- Two prior to the Effective Date.

Subject to Sections 9.4, 9.5 and 14.4(a), within ninety (90) days of the first achievement of the applicable milestone event (“Regulatory Milestone Event”), One-Two shall pay to CPP the applicable one-time, non-refundable, regulatory milestone payment set forth below (“Regulatory Milestone Payment”) upon the achievement of the corresponding milestone.

[*****] The maximum Delayed Milestone payable under this Agreement (if any) is a one-time payment of [*****]. The Regulatory Milestone Payment relates only to the FAP Product, and no Regulatory Milestone Payment will be due for any Product (other than the FAP Product). One- Two’s payment pursuant to this Section 9.2 shall be in accordance with the wire payment instructions received from CPP in writing no less than five (5) Business Days before the payment is due.

9.3       Royalties. In partial consideration of the licenses and rights granted to One-Two under this Agreement with respect to the Products, subject to Sections 9.4 and 9.5, One-Two shall pay CPP royalties on the aggregate Net Sales of Products by One-Two and its Affiliates and Sublicensees (subject to Section 10.3(c)) during each Calendar Year of the applicable Royalty Term for such Products in the Territory at the rates set forth below (with only clause (a) or (b) applying, as applicable, but not both).

(a)       [*****]

(b)      [*****]: One-Two shall pay to CPP a royalty of [*****] of (“Delayed Milestone Initial Royalty”) Net Sales of Products in the Territory, beginning on the date of First Commercial Sale of a Product in the Territory; provided that when such payments (together with payments deemed made) under the foregoing Delayed Milestone Initial Royalty, together with any other payments to CPP (or deemed paid to CPP) under this Agreement (e.g., the Upfront Amount (including the Sanofi Required Payments), the Delayed Milestone Payment and any applicable CPP Share of Expenses), total [*****] Dollars (“Delayed Milestone Step-Down Threshold”), One-Two shall pay to CPP for the remainder of the applicable Royalty Term(s) a royalty [*****] (“Delayed Milestone Capped Royalty”) of Net Sales of Products in the Territory. For clarity, any payments due to Sanofi as part of a One-Two Supply Payment shall not be included as part of the calculation for the Delayed Milestone Step-Down Threshold.

9.4      Pre-Approval Reimbursements. Payment of the applicable Regulatory Milestone Payment (as set forth in Section 9.2) or Net Sale royalties (as set forth in Section 9.3) shall be reduced on a dollar-for-dollar basis by any amounts funded by One-Two for One-Two’s direct employee, clinical and regulatory costs associated with any Development activities necessary to secure FDA approval for the Product in the U.S. for the FAP Indication (other than One-Two’s Share of Expenses as described in Section 9.5 below or any general overhead costs or expenses), as determined according to One-Two’s accounting methodologies generally and consistently applied and in accordance with U.S. generally accepted accounting principles. Such costs shall be offset (i) initially against the applicable Regulatory Milestone Payment and (ii) then, against any Net Sales royalties (as set forth in Section 9.3) due to CPP, unless One-Two determines to apply the offset in a different order. The amount of the reduced applicable Regulatory Milestone Payment or Net Sales royalties, as applicable, shall be deemed paid to CPP solely for the purposes of determining whether the Milestone A Step-Down Threshold or Delayed Milestone Step-Down Threshold, as applicable, has been reached.

9.5       Post-Approval Requirement Expenses. If the FAP Product is approved by the FDA with requirements for further clinical trials or compliance requirements (e.g., development of a REMS program, post-marketing commitments, clinical trials required to support accelerated approval, etc.), CPP and One-Two shall share on a 50/50 basis the associated expenditures for such post-approval clinical trial or compliance requirements that are required by the FDA (with CPP’s share referred to as the “CPP Share of Expenses” and One-Two’s share referred to as the “One-Two Share of Expenses”). The CPP Share of Expenses shall be funded by One-Two and offset on a dollar-for-dollar basis (i) initially against the applicable Regulatory Milestone Payment, but solely for any CPP Share of Expenses that have accrued as of the date such Regulatory Milestone Event payment is due or are estimated by One-Two to be incurred, based on a budget for such further clinical trials or compliance requirements prepared by One-Two in good faith (the “One-Two Post-Approval Compliance Budget”) and (ii) then, against any Net Sales royalties (as set forth in Section 9.3) due to CPP based on the One-Two Post Approval Compliance Budget. If following completion of the clinical trials or compliance requirements the actual CPP Share of Expenses is less than the amount offset against the applicable Regulatory Milestone Payment and/or Net Sales royalties, then One-Two will promptly reimburse CPP for such excess amount. For clarity, the One-Two Share of Expenses shall not be offset against any payments required to be made by One-Two to CPP under this Agreement. The CPP Share of Expenses that offset any payment otherwise payable by One-Two to CPP shall be deemed paid to CPP solely for purposes of determining whether the Milestone A Step-Down Threshold or Delayed Milestone Step-Down Threshold, as applicable, has been reached.

(a)        Accounts. All payments due CPP or One-Two shall be paid in Dollars and shall be transmitted to CPP or One-Two, as applicable, by bank wire transfer of immediately available funds. Either Party may change the designated bank account by written notice to the other Party signed by a duly authorized Representative of the changing Party. The remittance shall be made to the bank account of CPP in accordance with instructions provided to One-Two by CPP’s corporate controller.

(b)        Due. The applicable Party shall notify the other Party in writing no later than ten (10) Business Days after the occurrence of the applicable Regulatory Milestone Event set forth in Section 9.2. The applicable milestone set forth in Section 9.2 shall be due within ninety (90) days of achievement of the applicable Regulatory Milestone Event by or on behalf of One-Two. For the avoidance of doubt, a milestone payment will be payable only one time and no milestone payment will be paid in the event that the corresponding milestone event is not achieved in accordance with the terms and limitations set forth above. Within forty-five (45) days after the end of each Calendar Quarter, One-Two shall pay to CPP the total royalties, if any, due to CPP for such Calendar Quarter. Within thirty (30) days after the receipt of any invoice for other Payments or reimbursements due under this Agreement, a Party shall pay or reimburse the requesting Party.

(c)        Taxes. All payments made by One-Two to CPP pursuant to this Agreement (each, a “Payment”) shall be paid free and clear of any and all Taxes, except for any Taxes required to be deducted and withheld under applicable Law. CPP shall be solely responsible for paying any and all Taxes (other than withholding Taxes required by applicable Law to be deducted from Payments and remitted by One-Two) levied on account of, or measured in whole or in part by reference to, any Payments it receives. One-Two shall deduct or withhold from the Payments any Taxes that it is required by applicable Law to deduct or withhold and remit any such amounts to the applicable taxing authority, and all such amounts shall be treated as having been paid to CPP for all purposes of this Agreement. One-Two shall use commercially reasonable efforts to assist CPP in determining eligibility for exemption from, and claiming any reductions in, any Tax withholding requirements. Notwithstanding the foregoing, if CPP is entitled under any applicable Tax treaty to a reduction in the rate of, or the elimination of, applicable withholding Tax, it may deliver to One-Two or the appropriate governmental authority (with the reasonable assistance of One-Two) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve One-Two of its obligation to withhold such Tax, and One-Two shall apply the reduced rate of withholding or dispense with withholding, as the case may be, to the extent permitted by Law; provided that One-Two has received evidence of CPP’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization) reasonably in advance of the date that the applicable Payment is due. If, in accordance with the foregoing, One-Two withholds any amount, it shall send to CPP proof of remittance to the applicable taxing authority within ten (10) Business Days following such remittance.

(d)    Currency Conversion. The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars of Net Sales invoiced in other currencies shall be consistent with One-Two’s internal accounting practices.

(e)     Late Payments. Each Party shall be liable for interest on the aggregate amount of any payments that are not paid on or before the date such payments are due under this Agreement at a rate per annum equal to monthly prime rate as published by Citibank N.A., New York, New York, U.S., or any successor thereto, at 12:01 a.m. on the first day of each Calendar Quarter in which such payments are overdue or a comparable reference interbank rate per currency or the maximum rate allowable by applicable Law, whichever is lower; provided that with respect to any disputed payments, no interest payment shall be due until such dispute is resolved and the interest which shall be payable thereon shall be based on the finally-resolved amount of such payment, calculated from the original date on which the disputed payment was due through the date on which payment is actually made.

(f)     Payment for Third Party Licenses. During the Term, One-Two and its Affiliates will have the right, following reasonable consultation with CPP, to negotiate and obtain a license of intellectual property rights from one or more Third Parties (each such Third Party license (including any license granted in settlement of any litigation) is referred to as a “Third Party License”) if in the absence of such license the Development or Commercialization in the Territory or the Manufacture of the Product by or on behalf of One-Two would, in One- Two’s good faith assessment, infringe intellectual property rights of any such Third Party. If such license requires the payment of royalties or other consideration to such Third Party (collectively, “Third Party Payments”), then One-Two may offset against the Regulatory Milestone Payment and/or royalties that would otherwise be payable to CPP under this Agreement fifty percent (50%) (unless prior to the Effective Date, CPP knew that a Third Party License would be required, then for such Third Party License, fifty percent (50%) will be increased to one hundred percent (100%)) of the Third Party Payments actually paid to such Third Party for such a Third Party License. This Section 9.6(f) shall not apply to any One-Two Supply Payments or Third Party Payments payable by One-Two or any of its Affiliates or Sublicensees under any license or other agreement between One-Two or any of its Affiliates or Sublicensees, on the one hand, and any Third Party, on the other hand, in existence as of the Effective Date or to any payments by One-Two to Sanofi (or any of its Affiliates) under any supply agreement entered into between Sanofi (or any of its Affiliates) and One-Two as set forth in Section 3.7(a).

(i)    Commencing with the First Commercial Sale of a Product by One- Two or its Affiliates or Sublicensees, (a) within thirty (30) days after the end of each Calendar Quarter, One-Two shall make preliminary written reports to CPP stating in each such report, by Product, the estimated aggregate Net Sales in U.S. Dollars of Products sold in the Territory during such Calendar Quarter by One-Two and its Affiliates and Sublicensees, and (b) within forty-five (45) days after the end of each Calendar Quarter One-Two shall make final written reports to CPP stating in each such report, by Product, the aggregate Net Sales in U.S. Dollars of Products sold during such Calendar Quarter by One-Two and its Affiliates and Sublicensees. The final report shall also show (a) the calculation of the royalty payments due to CPP on such Net Sales (including aggregate gross amounts invoiced for such Product in each country in the Territory during the reporting period and the reductions or offsets applied pursuant to Sections 2.2(b), 9.4, 9.5 or 10.2(c)), (b) the amount of Taxes, if any, withheld to comply with applicable Laws, and (c) the exchange rates used in calculating the payments due CPP, which exchange rates shall comply with Section 9.6(d). If no royalties are due, One-Two shall so report. All preliminary and final reports delivered by One-Two under this Section shall be Confidential Information of One-Two; provided that information regarding revenue received hereunder by CPP may be shared as necessary with any CPP licensor to the Licensed IP to the extent required under the applicable license agreement for such Licensed IP; provided such CPP licensor is bound to keep such information confidential.

(b)    Records. One-Two shall and shall cause its Affiliates, or any licensee or Sublicensee of any of the foregoing, to, keep complete and accurate financial books and records pertaining to the Commercialization of Products hereunder in sufficient detail to calculate and verify all amounts payable hereunder. One-Two shall and shall cause its Affiliates and its and their Sublicensees to, retain such books and records for a period of three (3) years after CPP’s receipt of any report to which such records relate.

(c)     Audits. At the written request of CPP delivered to One-Two not less than thirty (30) days in advance (but no more than once during a Calendar Year), One-Two shall, and shall cause its Affiliates and its and their Sublicensees to, permit an independent certified public accounting firm of nationally recognized standing designated by CPP, with access upon reasonable notice and during normal business hours, and reasonably acceptable to One-Two for the sole purpose of verifying the accuracy of the financial reports and payments that are the subject of such audit, it being understood that any one period or periods being audited shall only be audited on a single occasion unless a prior audit has identified material discrepancies or issues. Each statement provided by One-Two and all records of One-Two, its Affiliates or any licensees or Sublicensees of the foregoing that are subject to inspection pursuant to this Section 9.7(c) shall be deemed to be the Confidential Information of One-Two subject to the confidentiality obligations of Article 11. The auditor will provide its report to CPP and One- Two at the same time. If as a result of any such audit or inspection, CPP reasonably concludes that One-Two has underpaid or failed to pay any amounts due under this Agreement for any audited period, CPP shall inform One-Two of such alleged non-payment or underpayment by a written notice setting forth in reasonable detail the amount of the alleged non-payment or underpayment and the basis for its calculation. Unless and to the extent One-Two disputes the amount of the non-payment or underpayment set forth by CPP in such notice, One-Two will pay to CPP the amount of such non-payment or underpayment within thirty (30) days of its receipt of such notice from CPP. In the event One-Two does dispute all or any portion of the alleged non- payment or underpayment set forth in such notice, One-Two will so notify CPP in writing within thirty (30) days after receipt of such notice and the Parties will attempt thereafter to resolve such dispute amicably and, if they cannot do so, they will submit the dispute for resolution to an independent third party accounting firm jointly selected by the Parties (the “Independent Arbiter”). The decision of the Independent Arbiter as to the amount, if any, of any non-payment or underpayment shall be final. The cost of such audit shall be borne by CPP, unless such audit reveals either non-payment of a milestone payment that was due under this Agreement or, in respect of the Net Sales, an underpayment or overcharge of more than seven and a half percent (7.5%) from the total reported amount owed to CPP in the applicable audit period, in which case One-Two shall pay the professional services fees of the auditor for such audit. If such audit concludes that excess amounts were paid by One-Two, One-Two shall be allowed to credit such excess amounts against future amounts owed, or, at its election, require CPP to refund the amount overpaid within thirty (30) days of such election.

Article 10

Intellectual Property Matters

(i)    As between the Parties, and subject to the licenses granted under this Agreement, each Party shall own or retain all rights, title, and interests in and to all Patent Rights, Know-How, and other intellectual property rights that: (i) such Party owns or otherwise Controls as of the Effective Date; or (ii) that such Party develops or otherwise acquires after the Effective Date outside the performance of the activities under this Agreement. Without limiting the foregoing, as between the Parties, CPP will continue to own all Licensed IP.

(ii)    The Parties acknowledge that during the course of performing their respective obligations under the Transaction Documents, certain Inventions, data, information, or other intellectual property may be conceived of or reduced to practice by a Party or the Parties, or their respective Affiliates or sublicensees, or employees or agents of any of them with respect to the FAP Product (“Collaboration Inventions”). Inventorship of any Collaboration Invention shall be determined in accordance with the patent laws of the United States of America. Except as otherwise specifically provided in a Transaction Document, each Party shall solely own all Collaboration Inventions made, developed, conceived, first reduced to practice, fixed in any tangible medium of expression or created solely by such Party or its Affiliates or sublicensees and their employees and agents, and the Parties shall jointly own all Collaboration Inventions jointly made, developed, conceived, first reduced to practice, fixed in any tangible medium of expression or created by both Parties or their Affiliates or sublicensees and their employees, or agents.

(i)    Each Party shall promptly disclose to the other all Collaboration Inventions that are in the nature of (a) any formulations of the FAP Product, including with respect to dosage size or frequency (e.g., weekly versus daily), delivery methods (e.g., oral versus injectable), (b) uses of the FAP Product to diagnose, prevent or treat any disease or condition other than FAP, including uses that include one or more steps to diagnose, identify, select, target, or exclude patient populations or personalize the therapy, (c) methods of Manufacture of the FAP Product (each such Invention in clauses (a)-(c) above, a “Product Improvement”), and related data and records, in sufficient detail to enable each Party to identify each inventor, creator, discoverer or author, as applicable, and to evaluate the patentability of each such Product Improvement. During the Term, CPP shall not disclose, use, license or Commercialize in the Territory any Product Improvement that relates to any Product.

(ii)    All Patents that Cover any Product Improvement that are Controlled by CPP or its Affiliates shall be deemed Licensed Patents, and all such Product Improvements that are not Covered by a Patent shall be deemed Licensed Know-How, and in each case subject to the license granted to One-Two under Section 5.1.

(iii)    If One-Two or any of its Affiliates Controls a Patent that Covers any Product Improvement (each, a “One-Two Product Improvement Patent”), One-Two hereby grants and agrees to grant to CPP a non-exclusive, worldwide, royalty-free, fully paid-up, perpetual, irrevocable license, with the right to grant sublicenses (through multiple tiers), subject to Section 15.2(a), under such One-Two Product Improvement Patent for any and all purposes; provided, however, that during the Term, CPP’s license under any One-Two Product Improvement Patents shall not include the right to perform activities in the Territory to the extent such activities are the subject of the exclusive license under the Licensed IP that is granted to One-Two under this Agreement.

(c)         Assignment Obligation. Each Party shall (i) cause all of its employees and agents and (ii) use commercially reasonable efforts to cause all other Persons, in each case ((i) and (ii)), who perform activities on behalf of such Party or its Affiliates in connection with this Agreement, to be under a written obligation to assign their rights in any intellectual property resulting therefrom to such Party, except where applicable Law requires otherwise. Each Party shall and hereby does assign to the other Party any right, title, and interest it may have in any Invention that is to be owned by the other Party pursuant to this Section 10.1, and agrees to execute such documents and take such other actions reasonably requested by the other Party to the extent necessary to give effect to the ownership allocation set forth in this Section 10.1.

(a)        Prosecution. As between the Parties, CPP, acting through outside patent counsel, shall have the first right, but not the obligation, to prepare, file, prosecute and maintain the Licensed Patents. CPP shall carry out any preparation, filing, prosecution and maintenance of such Licensed Patents with commercially reasonable efforts in any jurisdiction within the Territory or outside the Territory. One-Two shall cooperate with CPP in the preparation, filing, prosecution and maintenance of such Licensed Patents, including by providing CPP with data and other information as appropriate and executing all necessary declarations, affidavits, powers or attorney, assignments and other paperwork. CPP shall copy One-Two on all material correspondence from and to any patent office relating to such Licensed Patents in a timely manner, and CPP shall provide One-Two with drafts of all proposed filings and material correspondences to the patent authorities with respect to such Licensed Patents in reasonably adequate time before filing or submission of such materials, for One-Two’s review and comment. CPP will consider in good faith One-Two’s reasonable comments prior to submitting such filings and correspondences to the extent such comments are timely provided and it is practicable to do so; provided, however, that in the event of disagreement between the Parties regarding the content of any such filings or correspondence, CPP shall have the right to make the final decision regarding such matters, unless such matters are within the scope of CPP’s obligations and One-Two’s rights under Section 10.2(b) below. CPP further agrees that it will timely provide One-Two such information regarding the prosecution of Patents outside of the Territory that relate to (by claim of priority or shared subject matter) any of the Licensed Patents as One-Two may reasonably require to conduct its review of such matters. For the purpose of this Article 10, “prosecution” shall include any patent interference, opposition, pre-issuance Third Party submission, ex parte re-examination, post-grant review, inter partes review or other similar proceeding, appeals or petitions to any Board of Appeals in a patent office, appeals to any court for any patent office decisions, reissue proceedings, and applications for patent term extensions and the like, regardless whether said “prosecution” occurs in any jurisdiction within the Territory or outside the Territory.

(b)        Notice Not to File or Continue Prosecution or Maintenance. CPP shall notify One-Two of any decision not to file for, prosecute or maintain, or not to continue to pay the expenses of prosecution or maintenance of, any Licensed Patents in the Territory, including divisional and continuation Patents. CPP shall provide such notice at least thirty (30) days prior to any filing or payment due date, or any other due date that requires action, in connection with such Licensed Patent. In such event, One-Two shall, at its sole cost and expense, have the right, but not the obligation, to file for, or continue prosecution or maintenance of, such Licensed Patent. Without limiting the foregoing, CPP shall not take any action in respect of prosecution or maintenance of any Licensed Patent that is licensed to CPP under the Arizona License Agreement that would require CPP to provide notice to the University of Arizona (pursuant to Section 4.2 of the Arizona License Agreement) of its election to affirmatively abandon prosecution or maintenance of such Licensed Patent unless One-Two has expressly consented to such action in writing, and with respect to any such matters, CPP will provide notice to One-Two of its decision in sufficient time to enable One-Two to determine whether to exercise its rights under this Section 10.2(b) in respect of such Licensed Patent and to then timely notify the University of Arizona in accordance with Section 4.2 of the Arizona License Agreement in the event One-Two does not elect to continue prosecution or maintenance of such Licensed Patent.

(c)         Allocation of Costs. All costs and expenses incurred in connection with the preparation, filing, prosecution and maintenance of such Licensed Patents in the Territory shall be treated as follows: (i) if incurred by CPP, then One-Two shall reimburse CPP within thirty (30) days after CPP provides reasonable documentation of such expenses; and (ii) if incurred by One-Two directly, then One-Two may deduct such costs from any royalties due to CPP as set forth in Section 9.3.

(a)        Each Party shall give the other Party notice of any known or suspected infringement in the Territory by a Third Party of any Licensed Patent or One-Two Product Improvement Patent (“Patent Infringement”) within fifteen (15) Business Days after such Patent Infringement comes to such Party’s attention.

(b)        One-Two shall have the first right, but not the obligation, to bring and control any legal action, including by declaratory judgment action, patent litigation or similar proceeding, in connection with any Patent Infringement in the Territory (an “Enforcement”) at its sole cost and expense and discretion as it reasonably determines appropriate. One-Two shall keep CPP informed and reasonably consult with CPP in the course of such Enforcement, including, with respect to Licensed Patents, with sufficient notice and information to permit CPP to comply with its obligations under the Arizona License Agreement (including with respect to Section 6 of the Arizona License Agreement). One-Two shall cooperate with CPP in developing a strategy for such Enforcement to the extent such Enforcement may affect any rights, remedies, filing, prosecution, enforcement, or defense of CPP outside the Territory. CPP shall have the right to join or participate in any such Enforcement by counsel of its choice at its sole cost and expense.

(c)         At the request of One-Two, CPP shall reasonably cooperate and provide any information or assistance in connection with any Enforcement, including executing reasonably appropriate documents, cooperating in discovery and, if required by applicable Law, itself joining as a party or causing the University of Arizona to join as a party (solely to the extent permitted to do so under the Arizona License Agreement) to the action at One-Two’s cost.

(d)        In connection with any Enforcement, One-Two shall not enter into any settlement admitting the invalidity or unenforceability of, or otherwise impairing CPP’s rights in, the Licensed Patents (or any claim thereof) or One-Two Product Improvement Patents (or any claim thereof) without the prior written consent of CPP, such consent to be provided at CPP’s sole discretion, with respect to the Licensed Patents (or any claim thereof), or not to be unreasonably withheld, with respect to the One-Two Product Improvement Patents (or any claim thereof).

(e)        If One-Two does not commence an Enforcement within one hundred eighty (180) days after a notice from either Party under Section 10.3(a), then CPP shall have the right but not obligation, to commence an Enforcement at its own cost, if such Patent Infringement relates to the Licensed Patents; provided that CPP shall not settle any Patent Infringement in a manner that, without the express prior written consent of One-Two, diminishes or has a material adverse effect on the rights or interest of One-Two under this Agreement, imposes costs or liability on One-Two for which One-Two is not liable under this Agreement or applicable Law, or involves any admission of liability by One-Two. At the request of CPP, One- Two shall reasonably cooperate and provide any information or assistance in connection with such Enforcement, including executing reasonably appropriate documents, cooperating in discovery and, if required by applicable Law, itself joining as a party.

(f)         The Party commencing the proceeding shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider in good faith input from the other Party during the course of the Enforcement.

(g)        Any recoveries resulting from an Enforcement, including pursuant to a settlement, shall be applied as follows: (i) first to reimburse each Party, on a pro rata basis, for such Party’s out-of-pocket costs and expenses in connection with such Patent Infringement proceeding; (ii) any reimbursement required to the University of Arizona for its out-of-pocket costs and expenses in connection with such Patent Infringement proceeding, (iii) (A) if One-Two is the party initiating and conducting such Enforcement, the remaining amount of any recovery will be deemed Net Sales and allocated to the Parties in the same proportion as set forth in Section 9.3 or (B) if CPP is the party initiating and prosecuting the action, the remaining amount of any recovery shall be allocated such that eighty percent (80%) shall be retained by CPP and twenty percent (20%) shall be paid to One-Two; provided, that any portion of such remaining recovery that constitutes punitive or enhanced damages recovered by judgment (assuming that recoveries constituting punitive or enhanced damages are first applied to the foregoing costs and expenses) shall be retained by the enforcing Party.

(h)        One-Two acknowledges and agrees that One-Two’s rights under this Section 10.3 are subject to the rights and obligations of University of Arizona under the Arizona License Agreement.

10.4    Third Party Patent Proceedings. One-Two shall have the sole and exclusive right, but not the obligation, to control the defense to any legal action to challenge any Licensed Patents in the Territory or One-Two Product Improvement Patents in the Territory, including in connection with an Enforcement, declaratory judgment action, patent interference, opposition, pre-issuance submission, ex parte re-examination, post-grant review, inter partes review, patent litigation or similar proceeding, at its sole cost and expense. One-Two shall cooperate with CPP in developing a strategy for such action to the extent such action may affect any rights, remedies, filing, prosecution, enforcement, or defense of CPP outside the Territory. One-Two shall keep CPP reasonably informed of the status of such action. One-Two shall provide the CPP with copies of all pleadings and other documents filed with the court and shall consider in good faith input from CPP during the course of such action. At the request of One-Two, CPP shall reasonably cooperate and provide any information or assistance in connection with any legal action under this Section 10.4, including executing reasonably appropriate documents, cooperating in discovery and, if required by applicable Law, joining as a party to the action at One-Two’s cost and expense. In connection with any such action, One-Two shall not enter into any settlement admitting the invalidity or unenforceability of, or otherwise impairing CPP’s rights in, the Licensed Patents (or any claim thereof) or One-Two Product Improvement Patents (or any claim thereof) without the prior written consent of CPP, such consent to be provided at CPP’s sole discretion, with respect to the Licensed Patents (or any claim thereof), or not to be unreasonably withheld, with respect to the One-Two Product Improvement Patents (or any claim thereof).

10.5    Patent Extensions. The Parties shall cooperate in obtaining any available patent term restoration (under but not limited to the Drug Price Competition and Patent Term Restoration Act), supplemental protection certificates or their equivalents, and patent term extensions with respect to the Licensed Patents in any country or region where applicable. On a Product-by-Product and country-by-country basis, One-Two shall have the right to direct the filing of an Orange Book listing for one or more Licensed Patents or similar application for Regulatory Exclusivity in any country within the Territory and, in respect of any patent term extension for any such Licensed Patent, One-Two shall determine which Licensed Patent it will apply to extend the patent term of with respect to such Product in such country in the Territory. The Parties agree to cooperate and provide all reasonable assistance in connection with any such filing.

(a)        Prosecution. As between the Parties, One-Two, acting through outside patent counsel, shall have the first right, but not the obligation, to prepare, file, prosecute and maintain any One-Two Product Improvement Patents. One-Two shall carry out any preparation, filing, prosecution and maintenance of any One-Two Product Improvement Patents with commercially reasonable efforts. One-Two shall copy CPP on all correspondence from and to any patent office relating to such One-Two Product Improvement Patents in a timely manner, and One-Two shall provide CPP with drafts of all proposed filings and material correspondences to the patent authorities with respect to such One-Two Product Improvement Patents in reasonably adequate time before filing or submission of such materials, for CPP’s review and comment. One-Two will consider in good faith CPP’s reasonable comments prior to submitting such filings and correspondences to the extent such comments are timely provided and it is practicable to do so; provided, however, that in the event of disagreement between the Parties regarding the content of any such filings or correspondence, One-Two shall have the right to make the final decision regarding such matters.

(b)        Notice Not to File or Continue Prosecution or Maintenance. One-Two shall notify CPP of any decision not to file for, prosecute or maintain, or not to continue to pay the expenses of prosecution or maintenance of, any One-Two Product Improvement Patents, including divisional and continuation Patents. One-Two shall provide such notice at least thirty (30) days prior to any filing or payment due date, or any other due date that requires action, in connection with such One-Two Product Improvement Patent. In such event, CPP shall, at its sole cost and expense, have the right, but not the obligation, to file for, or continue prosecution or maintenance of, such One-Two Product Improvement Patent.

10.7     Third Party Infringement Claims. If any action, suit or proceeding is brought against either Party, or any Affiliate or sublicensee of either Party, alleging the infringement of the intellectual property rights of a Third Party by reason of the Development, Manufacturing or Commercialization of a Product, each of the Parties shall have the right, but not the obligation, to defend itself in such action, suit or proceeding at its sole cost and expense. The Parties shall cooperate with each other in any defense of any such suit, action or proceeding. The Parties shall give each other prompt written notice of the commencement of any such suit, action or proceeding, or receipt of any claim of infringement, and shall furnish each other a copy of each communication relating to the alleged infringement. Neither Party shall compromise, litigate, settle or otherwise dispose of any such action, suit or proceeding without the other Party’s advice and prior consent, provided that the Party not having the right to defend the suit shall not unreasonably withhold or delay its consent to any settlement which does not have a material adverse effect on its rights, obligations or benefits, either under this Agreement or otherwise. The Party first having actual notice of any claim, action or proceeding referenced in this Section 10.7 shall promptly notify the other Party in writing, setting forth in reasonable detail, to its knowledge, the facts related to any such claim, action or proceeding. The Parties shall promptly discuss proposed responses to any such matters.

10.8         Trademark Prosecution. CPP shall control the filing, prosecution and maintenance of the Licensed Marks. One-Two shall not (and shall cause its Affiliates and Sublicensees not to): (i) establish any Internet domain name or URL incorporating any Licensed Mark without CPP’s prior written consent; (ii) use the Licensed Marks in combination with any other name or trademark in a manner that creates a combination trademark; (iii) contest the validity of, or take any action that a reasonable person would believe would impair any part of CPP’s ownership of the Licensed Marks or diminish or dilute their distinctiveness or validity; (iv) challenge CPP’s ownership of the Licensed Marks and/or registration thereof; (v) use the Licensed Mark in any manner that would tarnish the Licensed Mark and/or the goodwill and/or reputation of CPP; or (vi) attempt to register any Licensed Mark or any trademark confusingly similar to any Licensed Mark as a trademark in One-Two’s own name. CPP acknowledges that One-Two has not yet decided to use the Licensed Marks for the FAP Product and the foregoing provisions of this Section 10.8 shall only apply if One-Two decides to use the Licensed Marks for the FAP Product.

10.9         Trademark Infringement/Enforcement. If One-Two is using the Licensed Marks, One-Two shall be solely responsible for the enforcement and defense of the Licensed Marks in the Territory, including the cost thereof. If One-Two is using the Licensed Marks, each Party will promptly notify the other Party of any infringement or threatened infringement of any of the Licensed Marks of which it becomes aware.

Article 11

Confidentiality

11.1     Confidentiality. “Confidential Information” means any technical and non-technical non-public or proprietary information related to a Party’s business, and current, future or proposed products belonging to such Party (“Discloser”) that is supplied or disclosed by the Discloser, its Affiliate or their respective Representatives to the other Party or its Affiliate or their respective Representatives (“Recipient”), including any scientific or technical information, clinical trial protocols, clinical data and analysis, formulae, data, software programs and source documents; information relating to Discloser’s financial affairs, products, potential future products, processes, services, customers, customer lists, business plans, marketing plans or analyses, employees, employee compensation, research, development, inventions, discoveries, non-published patent applications, works of authorship, manufacturing, engineering, purchasing, accounting, distribution, and marketing; and information that any Third Party has disclosed to Discloser in confidence and that Discloser is permitted to disclose to Recipient under the terms and conditions of this Agreement. In addition, the terms of this Agreement shall be treated as Confidential Information of both Parties.