definiens: means Know How that the Company Controls as at the Step - In Date or during the termof the Step - In Agreement that relates to any Collaboration Product for which a GLPToxicology Study has been initiated, and includes : a ) Know How related to safety, toxicology and efficacy or that is otherwise relevant tothe activities to be performed by or on behalf of CRT under the Step - in Agreement;and b ) Know How related to the manufacturing, production or expression, quality, safe andproper handling, storage or use of the Collaboration Products ; means the Materials that the Company Controls comprised in any part of aCollaboration Product and for which a GLP Toxicology Study has been initiated ; “ Collaboration Productmeans : 3 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,AS AMENDED Patents ” a ) the Patents that are Controlled by the Company that Cover the CollaborationProducts or any individual Collaboration Product ; and b ) all Patents that derive priority from the Patents identified in ( a ) ; means, in respect of the Company or a Sub - Licensee, the efforts and resourcescommonly used by a company of a similar size and with similar resources for aproduct at a similar stage in its life cycle, with the aim of developing orcommercialising that product in a diligent and timely manner, taking into accountsafety, efficacy and patent or other proprietary positions, provided that, with respect toa Sub - Licensee, will not require efforts or resourcesbeyond those negotiated diligently and in good faith by the Company in its agreementwith the Sub - Licensee ; means the entity identified in the Cover Sheet as the ‘ Company ’ ; has the meaning given in clause 14.1 of the Agreement ; means a research and development programme under which [ * * * ] ; means all information designated as confidential by any Party in writing together withall other information of a proprietary nature relating to the business, affairs, technology, products, developments, trade secrets, Know - How, personnel, customers, agents, distributors and suppliers of a Party disclosed by the Disclosing Party, that is not inthe public domain and is acquired by another Party under the Agreement . Results arethe Confidential Information of the Charity and CRT until the grant of the Licence to theCompany, whereupon they will become Confidential Information of the Company ; means third parties that perform activities under, in support of or for the Clinical Trial, and include, among others : a ) the chief and principal investigators that manage or supervise the Clinical Trial andall other investigators ; b ) experts ( including members of the Charity ’s expert committees or any other personnot an employee of the Charity whom the Charity engages to advise the Charity onthe Clinical Trial ) ; 4 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,AS AMENDED c ) NHS Trusts ; and d ) sub - contractors ; means, with respect to any Material or IP, the possession ( whether by ownership, licence or other right, other than pursuant to this Agreement ) by a Party of the ability togrant to another Party access or a licence ( or sub - licence ) as provided herein undersuch item or right without violating the terms of an agreement or other arrangementwith any third party or ( except as concerns the Control of rights to IP granted to theCharity by the Company in connection with the Clinical Trial ) increasing the costsborne by the Party granting such access or licence by reason of the grant of suchaccess or licence . When used in respect of Material or IP, and have a corresponding meaning ; means, with respect to a Patent, that the making, having made, using, selling, offeringfor sale or importing of a material or practice of a claimed method would infringe aclaim ( or, if not yet issued, would infringe if the claim were to issue ) of that Patent inthe country in which the activity occurs, and has a corresponding meaning ; means the cover sheet to this Agreement ; means any period of clinical trial data or other regulatory exclusivity, or other periodsunder national implementations in the European Union of Article 10.1 of the EuropeanDirective 2001 / EC/83 and all equivalents elsewhere in the Territory ; has the meaning given in clause 11.7 of the Agreement ; has the meaning given in clause 11.6 of the Agreement ; means a development plan that describes the steps to be taken to develop the Agent, any Agent Products or any Collaboration Products in the Field and the Territory andprovides an indication as to the relevant timescales within which such steps will betaken . ; ( or)means schemes ( whether statutory or not ) offered by Regulatory Authorities directedtowards making available, on an expedited basis, medicines that offer potential benefitto patients with no treatment options or a major therapeutic advantage over existingtreatments . EAMs include Medicines and Healthcare Products Regulatory Agency ’s ( or ) designations and EMA ’s proposed ( Priority Medicines ) 5 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,AS AMENDED scheme, and successor or similar schemes ; has the meaning given in clause 14.4.1 of the Agreement ; has the meaning given in clause 7.1 of the Agreement ; means : Chief Executive Officer of the Company, the Chief Executive Officer of CRTand the Director of the Charity ’s Centre for Drug Development ; means [ * * * ] ; means, [ * * * ] ; has the meaning given in clause 17.17.1 of the Agreement ; means any royalties on the sale of an Agent Product or a Collaboration Productpayable by the Company or a Sub - Licensee under a licence agreement entered into bythe Company or such Sub - Licensee with a third party after the Start Date, and only tothe extent that : ( i ) such licence is necessary in order to avoid infringing such thirdparty ’s patent rights in the course of researching, developing, making, having made, marketing, using, importing and selling Agent Products or Collaboration Products asdeveloped by the Company ; and ( ii ) the royalty payable is reasonably attributable to thegrant of rights specified in ( i ) and not to any other rights also granted pursuant to thesame licence agreement and/or by the same third party licensor