definiens: ( including, with correlative meanings,, and ) means ( a ) direct or indirect beneficial ownership of at least fifty percent ( 50 % ) of the voting share capital of a person, corporation or entity or ( b ) to possess, directly or indirectly, the power to direct the 2 management and pol icies of a person, corporation or entity whether through ownership of the voting share capital, by contract relating to voting rights or through corporate governance, or otherwise ; Allogeneic Product means any product containing Allogeneic T -Cell expressi ng chimeric NKG2D receptor Developed by CELYAD, and that is covered by CELYAD Patents, CELYAD Third Party Patents ( subject to Article 2.8 ), CELYAD Know -How and/or CELYAD Third Party Know -How ( subject to Article 2.8 ) . [ CONFIDENTIAL ] Allogeneic T -Cell means any T -Cell that is devoid of, or has an inhibited T -Cell Receptor function, and that is covered by CELYAD Patents, CELYAD Third Party Patents ( subject to Article 2.8 ), CELYAD Know -How and/or CELYAD Third Party Know -How ( subject to Article 2.8 ) ; Annual Ne t Sales means the total Net Sales of the Product sold by ONO, its Affiliates or ONO Sublicensees in the ONO Territory in a particular ONO Fiscal Year ; Applicable Law means all applicable laws, enactments, rules and regulations, regulatory policies, regula tory guidelines, industry codes, regulatory permits and regulatory licences, in each case which are in force from time to time in any jurisdiction where a Party conducts its activities under this Agreement ; Audit Period has the meaning given in Article 12 .4 ; Autologous Product means any product containing autologous T -Cell expressing chimeric NKG2D receptor Developed by CELYAD, and that is covered by CELYAD Patents, CELYAD Third Party Patents ( subject to Article 2.8 ), CELYAD Know -How and/or CELYAD Third P arty Know -How ( subject to Article 2.8 ) ; ASEAN Countries means [ CONFIDENTIAL ] Business Day means any day on which commercial banks in both Mont -Saint -Guibert, ( Belgium ) and Osaka ( Japan ) are generally open for business, other than a Saturday, a Sunday or a day within CELYAD ’s company -wide corporate holidays ( for CELYAD ’s obligations ) or ONO ’s company - wide corporate holidays ( for ONO ’s obligations ) ; Calendar Quarter means the period of three ( 3 ) consecutive calendar months ending either on March 31, June 30, September 30 or December 31, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first date to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term ; 3 Cancer Indication means a separate and distinct disease [ CONFIDENTIAL ] CELYAD Development Plan means the Development Plan established by CELYAD and to be performed by CELYAD in the Field in the CELYAD Territory ; CELYAD Existing Patent Rights has the meaning given in Article 17.2(d ) ; CELYAD Indemnities has the meaning given in Article 20.1 ; CELYAD Know -How means the CELYAD Owned Know -How and CELYAD Licensee Know - How ; provided that such term excludes Joint Know -How ; CELYAD Licensee means a Third Party to which CELYAD grants a license to Develop, Manufacture, and/or Commercialize the Product as such or as incorporated into other products in the Field outside the ONO Territory ; CELYAD Licensee Know -How means any and all Know -How that is Controlled by CELYAD Licensees as of the Effective Date or during the Term, that is necessary or reasonably useful in connection with the Development, Manufacturing, Use or Commercialization of the Product ; such CELYAD Licensee Know -How is subject to Article 2.7 ; CELYAD Licensee Patents means any and all Patents that are Controlled by CELYAD Licensees as of the Effective Date or during the Term, that are necessary or reasonably useful in connection with the Development, Manufacturing, Use or Commercialization of the Product ; such CELYAD Licensee Patents are subject to Article 2.7 ; CELYAD Licensee Promotional Ma terials has the meaning given in Article 9.4(c ) ; CELYAD Owned Know -How means any and all Know -How that is Controlled by or on behalf of CELYAD or its Affiliates ( under the conditions of Article 2.6 ) as of the Effective Date or during the Term, that is nec essary or reasonably useful in connection with the Development, Manufacturing, Use or Commercialization of the Product ; CELYAD Owned Patents means any and all Patents that are Controlled by or on behalf of CELYAD or its Affiliates ( under the conditions of Article 2.6 ) as of the Effective Date, as listed in Annex 1, or during the Term, that are necessary or reasonably useful in connection with the Development, Manufacturing, Use or Commercialization of the Product ; CELYAD Patents means the CELYAD Owned Pat ents and CELYAD Licensee Patents ; provided that such term excludes Joint Patent ; CELYAD Product Trademarks has the meaning given in Article 16.2 ; CELYAD Promotional Materials has the meaning given in Article 9.4(a ) ; 4 CELYAD Territory means the wor ld, other than the ONO Territory ; CELYAD Third Party Know -How means any and all Know -How that is Controlled by or on behalf of a Third Party ( other than a CELYAD Licensee ) and which CELYAD or its Affiliates license in as of the Effective Date or during th e Term, that is necessary or reasonably useful in connection with the Development, Manufacturing, Use or Commercialization of the Product ; such CELYAD Third Party Know -How is subject to Article 2.8 ; CELYAD Third Party Patents means any and all Patents tha t are Controlled by or on behalf of a Third Party ( other than a CELYAD Licensee ) and which CELYAD or its Affiliates license in as of the Effective Date or during the Term, that are necessary or reasonably useful in connection with the Development, Manufact uring, Use or Commercialization of the Product ; such CELYAD Third Party Patents are subject to Article 2.8 ; Clinical Supply Agreement has the meaning given in Article 10.1 ; Clinical Trial means a human clinical trial as described in 21 C.F.R. § 312.21 in the United State, or an equivalent clinical trial in a country or jurisdiction other than the United States ; Combination Trials has the meaning given in Article 8.3 ; Commercialization ( including any variations such as and ) means any and all activities of marketing, promoting, distributing, importing, exporting ( within the ONO Territory for ONO and the CELYAD Territory for CELYAD ), offering for sale, having sold and/or selling product, including without limitation defining pricing and reimbursement strategy, Marketing Authorization and pre -launch marketing strategy ; Commercialization Date means, with respect to a Product in the ONO Territory, the date of th e first sale of such Product to a Third Party ( other than the ONO Affiliates or the ONO Sublicensees ) in a country after all required Marketing Authorizations and formalities are granted for that Product in such country in the ONO Territory ; Commercially Reasonable Efforts means, with respect to any Party, the application by or on behalf of such Party of a level of resources and efforts to Develop, Manufacture and/or Commercialize the Product, as applicable, as would normally be exerted and employed by suc h Party, which is in line with the pharmaceutical industry average, in pursuing the development, Manufacture and/or Commercialization of its other pharmaceutical products of a similar stage of product life, safety, efficacy, intellectual property profile ( including the Patent situation and the freedom to operate ) and commercial potential ; where this term is used in relation to obligations of and/or rights granted by a CELYAD Licensee or ONO Sublicensee, this term shall be construed to mean that CELYAD or ON O shall use best efforts to ensure that such CELYAD Licensee or ONO Sublicensee shall comply with such obligations and/or grant such rights ; Commercial Supply Agreement has the meaning given in Article 10.1 ; Common Brand Name has the meaning given in Article 16.1 ; Completion of a Clinical Trial means [ CONFIDENTIAL ] Confidential Information means all Information and materials which a Party or its Affiliates receives from the other Party or its Affiliates, either directly or f rom any other person specified by such other Party or its Affiliates, during the Term ; 5 Control ( including any variations such as and ) in the context of intellectual property rights, data and/or information, means that, re gardless of whether a person, corporation or entity owns or has a license to such intellectual property rights, data and/or information, such person, corporation or entity has the right to grant access to, and/or the right to grant the applicable license o r sublicense under this Agreement, to such intellectual property rights, data and/or information, without violating the terms of an agreement or other arrangement with any Third Party ; Dartmouth means Trustees of Dartmouth College which is a non -profit ed ucational and research institution existing under the laws of the State of New Hampshire, and being located at Hanover, New Hampshire 03755 ; Data means any and all research, pharmacology, formulation, non -/pre - clinical, safety data ( clinical and non-/pre - clinical ), process development, manufacturing, commercial, marketing and other data or information, including investigator brochures and reports ( both preliminary and final ), statistical analyses, expert opinions and reports related or directed to the Prod uct ; Development ( including any variations such as and ) means the activities, including the non -/pre - clinical development as well as the clinical development, performed by a Party toward the Commercialization of the Product, includi ng without limitation : activities related to research, process development and manufacturing, non -/pre - clinical and clinical drug development of the Product in the Field and in the relevant Party ’s territory, test method development and stability testing, assay development, toxicology, pharmacology, formulation, quality assurance, quality development, technology transfer, statistical analysis, process development, scale -up, pharmakocinetic studies, data collection and management, clinical studies, Clinical Trials, regulatory affairs, drug safety surveillance activities related to clinical studies and Clinical Trials and validation of methods and tests ; Development Plan means, for the Product, a working document describing as appropriate the indication(s ), e xpected timelines of the non -/pre - clinical, clinical, manufacturing, regulatory and other activities as appropriate ; Directors has the meaning given in Article 25.2 ; Disclosing Party has the meaning given in Article 18.1 ; Disputes has the meaning given in Article 25.2 ; Executives has the meaning given in Article 25.2 ; Expanded Territory means [ CONFIDENTIAL ] Expansion Notice has the meaning given in Article 4 ; Expansion Exercise Notice has the meaning given in Article 4 ; Field means all human prescri ption uses of the Product, [ CONFIDENTIAL ] 6 First Allogeneic Trial means [ CONFIDENTIAL ] Force Majeure has the meaning given in Article 28.1 ; Generic Country has the meaning given in Article 11.2(a)(ii ) ; Generic Product means a product that obtains marketing authorization of such product in the ONO Territory, whether for use as monotherapy or for use in combination with any other vaccine, biologic or compound, which is approved by an approval process for a generic produc t ( or other product equivalent thereto under the name other than a generic product ) under Applicable Law ; Global Clinical Trial means a Clinical Trial covering both of the CELYAD Territory and the ONO Territory ; Indemnitee has the meaning given in Articl e 20.3 ; Indemnitor has the meaning given in Article 20.3 ; Information means all technical, scientific, regulatory and other information, results, knowledge, techniques, in whatever form and whether or not confidential, proprietary, patented or patentable, including Inventions, invention disclosures, plans, processes, practices, methods, know how, skill, experience, ideas, concepts, Data, compilations of data, databases, SAS datasets, programs, software models, algorithms, experimental works, specification s, improvements, developments, modifications, compositions of matter, formulas, formulations, articles of manufacture, discoveries, findings, devices, assays, biological, chemical, physical or other materials, analytical and quality control data, formulae, marketing, pricing, price, distribution, organization, cost, sales, and manufacturing data or descriptions ; Initiation Party has the meaning given in Article 15.4(e ) ; Invention means any new process, machine, manufacture, or composition of matter, or an y new improvement thereof, whether patentable or not, that is made on the Effective Date or during the Term by a Party in connection with or relating to the Development, the Manufacturing, the Use and/or the Commercialization of the Product ; IND means an application submitted to a Regulatory Authority to obtain the right to perform Clinical Trials ; Indemnified Losses means any losses, damages, costs and expenses ( including, without limitation, reasonable legal and/or attorney ’s fees ), or any amounts agree d to be paid by way of settlement or compromise ; Initiation of a Clinical Trial means [ CONFIDENTIAL ] Intellectual Property Rights means ( i ) copyrights, Patents, database rights and rights in trademarks, designs, Know -How or trade secrets ( whether registe red or unregistered ), ( ii ) all other intellectual property rights and equivalent or similar forms of protection and ( iii ) applications for registration, and the right to apply for registration, for any of these rights, including renewals, divisional, conti nuations, continuations in part, converted provisionals, continued prosecution applications, reissues and extensions ; 7 IPR Claim has the meaning given in Articles 21.1 and 21.4 ; JCC Chairpersons has the meaning given in Article 14.3 ; JDC Chairpers ons has the meaning given in Article 14.1 ; Joint Commercialization Committee or JCC means the joint commercialization committee formed by the Parties as described in Article 14.3 ; Joint Development Committee or JDC means the joint development committee f ormed by the Parties as described in Article 14.1 ; Joint Invention has the meaning given in Article 15.1(c ) ; Joint Know -How means any and all Know -How Controlled by or on behalf of, both ONO or its Affiliates and CELYAD or its Affiliates, as of the Effec tive Date or during the Term ; Joint Patent has the meaning given in Article 15.1(c ) ; Know -How means Information that is related to the Product or that is necessary or useful for the Development, Commercialization, Use or Manufacturing thereof in the Field ; Lead Party has the meaning given in respectively Articles 15.2(b ) and 15.2(c ) ; Liaison means an individual to serve as the contact for each Party to exchange information, facilitate communication and coordinate the Parties ’ activities under this Agreement relating to the Development, the Manufacturing, Use and Commercialization of the Product ; Manufacture means any activity related to the production, the manufacturing, processing, filling, packaging, labeling, shipping, supplying and holding of a compound or product or any intermediate thereof, including process development, process qualificati on and validation, scale -up, non / pre -clinical, clinical and commercial manufacture and analytic development, product characterization, quality assurance and quality control ( including in -process testing, release testing or stability testing ) . When used as a verb, and mean to engage in Manufacture ; has a corresponding meaning ; Marketing Authorization means the authorization granted by the competent Regulatory Authority to ONO in the ONO Territory, which author izes the Commercialization of the Product in the ONO Territory ; NDA means a new drug application in the United States or an equivalent application in a country or jurisdiction other than the United States ; Net Sales means, with respect to the Product, the gross invoiced sales of such Product by ONO or its Affiliates or ONO Sublicensees, as applicable, to Third Parties after the first Commercialization Date of such Product, less the following deductions to the extent ( a ) reasonable and customary and ( b ) included in the gross invoiced sales price for such Product or otherwise directly paid or incurred by ONO or its Affiliates or ONO Sublicensees, as applicable, with respect to the sale of such Product : ( i ) [ CONFIDE NTIAL ] 8 ( ii ) [ CONFIDENTIAL ] ( iii ) ( iv ) ( v ) ( vi ) ( vii ) it being understood that for calculation of the Net Sales, only reasonable discounts are taken into account that are substantially in line with discounts given by ONO for products other than the Product ; Non - Affected Party has the meaning given in Article 28.1 ; Non - Exclusivity Country has the meaning given in Article 11.2(a ) ; ONO Development Plan means the Development Plan established by ONO and to be performed by ONO in the Field and in the ONO Territory ; ONO Fiscal Year means each successive period of twelve ( 12 ) months commencing on April 1 of a particular calendar year and ending on March 31 of the immediately following the calendar year ; ONO Indemnities has the meaning given in Article 20.2 ; ONO Know -How means any and all Know -How Controlled by or on behalf of ONO or its Affiliates ( or ONO Sublicensees, if applicable ) during the Term ; provided that such term excludes Joint Know -How ; ONO Necessary License has the meaning given in Article 11.3 ; ONO Patents means any and all Patents that are Controlled by or on behalf of ONO or its Affiliates ( or ONO Sublicensees, if applicable ) during the Term, that are necessary or reasonably useful in connection with the Development, Manufacturing, Use or Commercializatio n of the Product ; provided that such term excludes Joint Patent ; ONO Product Trademarks has the meaning given in Article 16.2 ; ONO Promotional Materials has the meaning given in Article 9.4(b ) ; ONO Preferred Indication means [ CONFIDENTIAL ] 9 ONO S ublicensee means a Third Party to which ONO grants a license to Develop, Manufacture, have Manufactured and/or Commercialize the Product, as such or as incorporated into other product in the Field in the ONO Territory ; ONO Sublicensee Promotional Material s has the meaning given in Article 9.4(d ) ; ONO Territory means Japan, South Korea and Taiwan ; Other Intellectual Property Rights has the meaning given in Article 16.3 ; Other Party has the meaning given in respectively Articles 15.2(b ), 15.2(c ), 15.3(b ) and 15.3(c ) ; Patent means ( a ) all national, regional and international patents, ( b ) all patent applications filed either for such patents, or provisional applications or for an application claiming priority from either of these, including divisionals, con tinuations, continuations in part, converted provisionals, continued prosecution applications, reissues and extensions, ( c ) any and all patents that have been issued or will in the future be issued for the foregoing patent applications ( ( a ) and ( b ) ) ; Phas e 2 Clinical Trial means a Clinical Trial for which the primary endpoints include a determination of dose ranges or an indication of efficacy of a Product in patients being studied, as described in 21 C.F.R, § 312.21(b ) in the United States, or an equivalen t Clinical Trial in a country or jurisdiction other than the United States ; provided, however that Phase 2 Clinical Trial shall not include a Clinical Trial that is intended to initially evaluate the safety or pharmacological effect of a Product in patient s in the ONO Territory ( i.e. phase 1/2 Clinical Trial ) ; Presenting Party has the meaning given in Article 18.7 ; Product means the Allogeneic Product ; Prosecution and Maintenance ( including variations such as and ) means, with respe ct to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as continuations, divisionals, re -examinations, reissues and requests for patent term extensions and the like with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to a Patent and over which a patent authority has jurisdiction ; Recipient has the meaning given in Article 18.1 ; Regulatory Authority means any federal, national, mul tinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the Development, Manufacturing, Commercialization, Use, reimbursement or pricing of a pharmaceutical product, including the FDA, E MA and Japan ’s Pharmaceuticals and Medical Devices Agency ; Regulatory Documentation means all ( i ) applications ( including all IND, NDA, registrations, licenses, authorizations, and approvals ( including all Marketing Authorization ) ), ( ii ) correspondence an d reports submitted to or received from Regulatory Authorities ( including minutes and official contact reports relating to any communications with any Regulatory Authority ) and all supporting documents with respect thereto, including all regulatory drug li sts, advertising and promotion documents, adverse event files, and complaint files and ( iii ) Data contained in any of the foregoing, in each case ( ( i ), ( ii ), and ( iii ) ) relating to the Product ; 10 Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to the Product other than a Patent right ; Reviewing Party has the meaning given in Article 18.7 ; Royalty Rate has the meaning given in Art icle 11.2 ; Royalty Term means, [ CONFIDENTIAL ] South Korea means the Republic of Korea ; Taiwan means the territories effectively controlled by the Republic of China ( Taiwan ) ; Tax means any sales, purchase or turnover tax as may be applicable in any rele vant jurisdiction ; Tax Deduction means a deduction or withholding for or on account of withholding or income tax from a payment under this Agreement ; Taxation Document means the tax documents necessary from time to time in order for ONO ( i ) not to withho ld tax or ( ii ) to withhold tax at a reduced rate under an applicable bilateral income tax treaty ; Term has the meaning given in Article 22.1 ; Third Party means any person, corporation or entity that is not a Party to this Agreement, which for the avoidan ce of doubt also excludes a Party ’s Affiliates ; Third Party Claim has the meaning given in Article 20.1 ; Use means any utilisation of the Product that is not considered as a Commercialization, Development and Manufacture of the Product ; Valid Patent Cla i m means ( i ) a claim of an issued and unexpired Patent, included within CELYAD Patent or CELYAD Third Party Patent in the ONO Territory which claim ( a ) has not been revoked or held unenforceable or invalid by a decision of a court or other governmental age ncy, national or regional patent office or other appropriate body of competent jurisdiction ( which decision is not appealable or has not been appealed within the time allowed for appeal ) and ( b ) has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re -examination or disclaimer or otherwise or ( ii ) a claim of a pending patent application within a CELYAD Patent or CELYAD Third Party Patent in the ONO Territory that was filed and is being prosecuted in good faith and has n ot been abandoned or finally disallowed without the possibility of appeal or re -filing of the application ; [ CONFIDENTIAL ] Working Group has the meaning given in Article 14.8(b )