definiens: means any indication that is not the Primary Indication, including, but excluding for the avoidance of doubt such as changes to the active substance, the strength, the pharmaceutical form and the route of administration ; 11 means ( a ) all patents, patent applications, utility models and design patents in any country orsupranational jurisdiction, and ( b ) any provisionals, substitutions, divisions, continuations, continuations inpart, reissues, renewals, registrations, confirmations, reexaminations, extensions, supplementary protectioncertificates and the like, of any such patents or patent applications ; means any national or federal institution, including, without limitation, Regulatory Authorities andprivate health insurance companies, having jurisdiction or influence over the pricing, market access, fundingreimbursement or usage restrictions of the Product in the Field in the applicable country in the Territory ; or has the meaning given to it in Clause 13.1 ; means an offering for sale of more than one product from a party ’s products, whetherowned or licensed - in products ; means the ex - manufacturer price of the Product per FP Dose, applicable for sales by or on behalf ofLicensee to an unconnected Third Party in an arm ’s length sale ; This ex - manufacturer price should be published in an official journal, or a document produced or recognized bythe Payer, the government or the main institution determining pricing and market access decisions in acountry . For decisions concerning the Price prior to the effective Commercialization, other sources may beacceptable if it is common practice in a country that the price is communicated in a different form prior to theeffective Commercialization ; If the ex - manufacturer price is not published, but a different price metric such as a public price or wholesaleprice is published, Licensee will provide Licensor with the ex - manufacturer price based on margins and taxespublished in an official journal, or a document produced or recognized by the Payer, the government or themain institution determining pricing and market access decisions in a country ; If the ex - manufacturer price is not published and applicable margins are not publicly available in a country, orif no price metric is publicly available, Licensee will provide Licensor with a reasonable estimate of theapplicable ex - manufacturer price ; If there is no single applicable ex - manufacturer price in a country, the weighted average ex - manufacturer pricebased on available sales data in this country should be used ; For the avoidance of doubt, no discounts potentially granted by Licensee to any Third Party, nor any discounts imposed by, negotiated with or otherwise paid to any Regulatory Authorities or Payers, nor any Taxes relating to the Product, will be deducted from the ex - manufacturing price ; 12 means the treatment of refractory, complex perianal fistulas in Crohn ’s disease, it beingunderstood that the exact wording of the Primary Indication will depend on the labelling finally approved by theRegulatory Authorities in the EEA ; means the brand, as covered by the applications and registrations set outin Schedule 2 hereto ; means the Cx601 product of Licensor, defined as a suspension of allogeneic expanded adipose - derived stem cells for local administration resulting from the Product Manufacturing, or any other productwhose manufacture, use or sale would, in the absence of a license from Licensor, constitute direct, indirect, contributory or any other type of infringement of one or more claims of the Licensor Intellectual PropertyRights ; has the meaning given to it in Clause 15.7 ; means the manufacturing of the Product, starting with MCS Manufacturing followedby FDS Manufacturing and finally FP Manufacturing ; means the agreement to be entered into between the parties setting out the qualityrequirements of the Product Manufacturing and the Product itself, and the parties ’ responsibilities in thisrespect, according to Applicable Laws in the applicable country in the Territory ; has the meaning given to it in Clause 19.3 ; means, including for purposes of Clause 28.4.1, any of the following ( groups of ) countries : ( 1 ) EEA;(2 ) Canada ; ( 3 ) Japan ; ( 4 ) China, ( 5 ) Asia Pacific, ( 6 ) CIS, ( 7 ) Latin America, ( 8) MENA ; ( 9 ) South Africa ; means any and all approvals, licenses ( including product and establishment licenses),permits, certifications, registrations, or authorizations of any Regulatory Authority necessary to Develop, Manufacture and Commercialise the Product for use in the Field in the applicable country in the Territory, including all INDs, MAAs and the manufacturing license and marketing registration required under theApplicable Laws of such applicable country in the Territory, or any update thereto, as well as pre- and post - approval marketing studies, labelling approvals, technical, medical and scientific licenses ; means any national, supra - national, regional, federal, state, provincial or localregulatory agency, department, bureau, commission, council or other governmental entity ( including, withoutlimitation, the EMA and any governmental unit having jurisdiction over the Development, Manufacture, andCommercialization of the Product in the Field in the applicable country in the Territory ) ; has the meaning given to it in Clause 24.2 ; 13 has the meaning set out in Clause 9.4 ; means stock keeping unit ; or means any form of tax or taxation, levy, duty, charge, social security charge, contributionor withholding of whatever nature ( including any related fine, penalty, surcharge or interest ) imposed by, orpayable to, any government, state or municipality, or any local, state, federal or other fiscal, revenue, customs, or excise authority, body or official anywhere in the world ; means any government, state or municipality, or any local, state, federal or other fiscal, revenue, customs, or excise authority, body or official anywhere in the world, authorized to levy Tax ; has the meaning given to it in Clause 9.7 ; has the meaning given to it in Clause 28.1 ; means the entire world, excluding ( i ) the United States of America and ( ii ) subject to Licensee notexercising its rights under Clause 2, Japan and Canada ; means any person other than Licensor, Licensee or their respective Affiliates ; has the meaning given to it in Clause 28.4.1 ; means a cease and desist letter or a letter or other written communication sent by aThird Party, explicitly and/or inherently alleging that the conduct of development, commercialization ormanufacturing activities of the Product in the Territory infringes, misappropriates, violates or makesunauthorised use of such Third Party ’s Intellectual Property Rights or requesting a comment about the party’sassumed right to the alleged use of such Third Party ’s Intellectual Property Rights or including any writtenclaim offering a license to the party or that the party must license or refrain from using such Third Party’sIntellectual Property Rights