definiens: means any Patents filed by or on behalf of or with the authority of UCLB ( for itself or on behalf of UCL ), in respect of which the priority fi ling is first filed after the Effective Date, and w hich Orchard has elected to include in its licence hereu nder pursuant to Clause 8.1.2 ; means UCLB, [COMPANY] and Orchard or, as the context req uires, two or more of them, and shall mean one of them ; means all patent rights, claims in any patent righ ts, applications for patents and the right to apply for patent rights in any part of the world in cluding all divisionals, reissues, extensions, substitutions, confirmations, registrations, revali dations, additions, continuations and any supplementary protection certificates or patent term extensions a nd where referred to in the context of a schedule h ereto shall include all patent rights from time to time d erived from, claiming priority from, issued or gran ted from those patent rights listed in such schedule ; means costs to file for, prosecute the application of, and maintain Patents, including Patent searches in the US and other countries as re quired to be undertaken in connection with a Patent application ( but not general freedom - to - operate or patentability searches ), preparation, drafting, fil ing, prosecution, maintenance and attorney fees in respe ct of Patents ; has the meaning in Clause 3.4.2 ; means the condition called haemophagocytic lymphoh istiocytosis ( HLH ) caused by perforin deficiency ; means any gene therapy products or therapies Explo ited by Orchard, or any of its Sub - licensees pursuant to a sub - licence granted hereunder, which is labelled, approved or otherwise marketed by Orchard and/or its Sub - licens ees for the Perforin Deficiency indication and ( i ) which would, were it not for the existing licen ce to the Perforin IP hereunder, infringe a Valid C laim of any Patents included in the Perforin IP ; ( ii ) in which final product, the Perforin Deficiency Vecto r is incorporated in or is used in the manufacture or de livery of that final product ; and/or ( iii ) which us es in Orchard ’s development of such product, or the manuf acture of such product, or is incorporated in such product, any Perforin Deficiency Know - how ; means the program of research in respect of Perfori n deficiency defined in Part C of Schedule 2 as has been overseen by or conducted by either or both of the Thrasher Researc h Group and Gaspar Research Group prior to the Effect i ve Date ; means a vector containing the sequences defined in Part C of Schedule 2 together with any modifications and derivatives the reof that result in sequences having an [ * * * ] homology to one of those sequences defined in Part C of Schedule 2 ; 9 means ( i ) all Know - how listed and identified under the title Scheduled Perforin Know - how in Part C of Schedule 2 ( the ) ; ( ii ) all Know - how ( other than the Scheduled Perforin Know - how ) existing as of the Eff ective Date that was ( a ) created, generated or developed from or in connection with the Perforin D eficiency Project, and/or ( b ) used in connection wi th the Perforin Deficiency Project and which UCLB is f ree, as of the Effective Date, to license to Orchar d, ( together ( a ) and ( b ) with the Scheduled Perforin K now - how, the ) ; ( iii ) any New Patents filed by or on behalf of or with the author ity of UCL and/or UCLB claiming any of the Perforin Know - how ( iv ) all IP, in the Materials used in conn ection with the Perforin Deficiency Project and whi ch UCLB is free, as of the Effective Date, to license to Orchard, and in Materials otherwise generated an d / or developed pursuant to the Perforin Deficiency Proje ct, together with the Perforin Deficiency Vector an d those other Materials listed under Part C of Schedu le 2 ; means, excluding the Documentary Materials, all ot her physical materials including biological and chemical materials and sam ples, cell lines, vectors, constructs, viruses, plasmids, nucleic acid sequences, Patient Samples, clinical trial materials, histology samples and rea gents ( and fragments, mutants, derivatives, progeny and p rocessed components thereof ) relevant to any of the Projects ; means [ * * * ], also known as [ * * * ] ; means any gene therapy products or therapies Explo ited by Orchard, or any of its Sub - licensees pursuant to a sub - licence granted hereund er, which is labelled, approved, or otherwise marke ted by Orchard and/or its Sub - licensees for the [ * * * ] a nd ( i ) which would, were it not for the existing li cence to the [ * * * ] hereunder, infringe a Valid Claim of a ny Patents included in the [ * * * ] ; ( ii ) in which fin al product, the [ * * * ] is incorporated in or is used in the manufacture or delivery of that final product ; and/or ( iii ) which uses in Orchard ’s development of such p roduct, or the manufacture of such product, or is [ * * * ] ; means the program of research in respect of [ * * * ] defined in Part D of Schedule 2 as has been overseen by or conducted by either or both the Thrasher Research Group and Gaspar Research Group prior to the Effective Date ; means ( i ) the LCR - EFS Patents ; ( ii ) all Know - how i n inventions claimed in the LCR - EFS Patents ; ( iii ) all Know - how listed and identified u nder the title Scheduled [ * * * ] in Part D of Schedul e 2 ( the Know - how at ( ii ) and ( iii ) being the ) ( iv ) all Know - how ( beyond the [ * * * ] ) existing as of the Effective Date that was ( a ) crea ted, generated or developed from or in connection w ith the [ * * * ] Project, and/or ( b ) used in connection wi th the [ * * * ] Project and which UCLB is free, as of the Effective Date, to license to Orchard ( ( ii ), ( iii ) and ( iv ) together being the ) ; ( iv ) any New Patents claiming any of the [ * * * ] ; ( v ) all IP in the Materi als used in connection with the [ * * * ] and which UCL B is free, as of the Effective Date, to license to Or chard, and in Materials otherwise generated and/or developed pursuant to the [ * * * ], together with the [ * * * ] and those other Materials listed under Part D of Schedule 2 ; means the vector defined in Part D of Schedule 2, together with any modifications and derivatives thereof that result in an LCR - EFS Vecto r targeting [ * * * ] ; means the [COMPANY] Principal Researcher and the UCL Pr incipal Researchers, or as the context requires any combination of the fore going ; means, as the context requires, two or more of the ADA SCID Project, LCR - EFS Platform Project, MPS1 Project, Perforin Deficiency Project and the [ * * * ] Project, and shall mean any one of them ; 10 has the meaning given in Clause 10.1 ; means any and all approvals ( including any applica ble supplements, amendments, pre and post approvals, and approvals o f applications for regulatory exclusivity ), licence s, registrations, or authorisations of any federal, na tional, multinational, state, provincial or local r egulatory agency, department, bureau, commission, council or other governmental entity necessary for the manufacture, distribution, use, testing, developmen t, storage, import, export, transport, promotion, marketing and sale of a medicinal product or therap y in a country or countries ; means any governmental or regulatory authority res ponsible for assessing applications for and/or granting Regulatory Approva ls ( including any ethics committees ) and shall mean more than one s uch authority ; means any applications, approvals or designations providing regulatory incentives ( over and above ordinary marketing appro vals ) for the research, development and/or approval of medicinal products or therapies, including orpha n drug designations, rare paediatric disease priori ty review vouchers and PUMAs ; means in respect of a Gene Therapy Product, the pa ckage or packages of pre - clinical and clinical data and Documentary Mate rials, information, results, Physical Materials and samples ( including any Clinical Data ) submitted to a Regulatory Authority in support of any Regulatory Approval ; means the Kohn Research Group, the Thrasher Resear ch Group and Gaspar Research Group, or as the context requires any comb ination of the foregoing ; means the Full Rate or Reduced Rate as set out in the table at Clause 5.4.1 ; means in respect of a particular Gene Therapy Prod uct for which Orchard or any Sub - licensee ( pursuant to a sub - licence granted hereund er ) has received the first Marketing Approval in a country in the Territory, the grant of a Marketing Approval to Orchard or any Sub - licensee ( pursuant t o a sub - licence granted hereunder ) in respect of the sa me Gene Therapy Product for the same therapeutic indication by a Regulatory Authority having jurisdi ction in a second country in the Territory that is different from that country where the same Gene The rapy Product has previously been approved ( for the benefit of Orchard or Sub - licensee ), it being ackno wledged that Marketing Approvals granted in a secon d country under the mutual recognition procedure or c entralised approval procedure in any country within the EU, EEA and/or EFTA shall not constitute a Seco nd MA, where the first Marketing Approval was granted by a Regulatory Authority with jurisdiction anywhere in or throughout the EU, EEA or EFTA ( including EMA ) ; or means the shareholders ’ agreement relating to Orcha rd to be entered into on or around the date of this Agreemen t ; or means an agreement pursuant to which clinical and non - clinical research services, and other fee - for - servi ce services are provided ; 11 means the gross sums received by Orchard pursuant to the grant of a sub - licence ( under Clause 2.6 ) of the Technology licens ed hereunder in so far as they are attributable to the Technology so licensed less all tariffs, duties, ta xes, excise, sales and value added taxes . The calcu lation of Sub - Licence Net Receipts shall be subject to the following : a ) Sub - Licence Net Receipts will include payments f or the grant of a sub - licence to the Technology including up front signing fees, stage payments and milestone payments . [ * * * ] ; and, b ) Sub -Licence Net Receipts will exclude [ * * * ] ; means any Third Party or Affiliate of Orchard to w hom Orchard grants a sub - licence of any of its rights under this Agreement in accordanc e with Clause 2.4 to commercialise any Gene Therapy Product ; or means in respect of any Patent, any of ( i ) ceasing to maintain ( by payment of renewal fees or otherwise ) the applicabl e Patent ; ( ii ) withdrawing, surrendering, dedicatin g to the public or allowing the applicable Patent to lap se ; ( iii ) in the case of a pending application de - designating, or not validating or ratifying in, a c ountry covered by the application or not entering i nto the national or regional phase in a country designated in the international or convention application or ( iv ) consenting to or ceasing to defend an applicat ion, action or litigation for revocation ; means the Joint UCLB / [COMPANY] Technology, UCLB Technolo gy and UCLB Manufacturing Technology ; has the meaning in Clause 12.1.1 ; means all countries throughout the world ; means in respect of a particular Gene Therapy Prod uct that has already been the subject of a Second MA, the grant of a Marketing Approval to O rchard or any Sub - licensee ( pursuant to a sub - licence granted hereunder ) in respect of the same G ene Therapy Product for the same therapeutic indication by a Regulatory Authority having jurisdi ction in a third country that is different to the countries in the Territory to where that same Gene Therapy Product has previously been approved ( for the benefit of Orchard or its Sub - licensee ), it bei ng acknowledged that Marketing Approvals granted in a third country under the mutual recognition procedur e or centralised approval procedure in any country within the EU, EEA and/or EFTA shall not constitute a Third MA, where any of the previous Marketing Approvals were granted by a Regulatory Authority wi th jurisdiction anywhere in or throughout the EU, EEA or EFTA ( including EMA ) ; means any person other than the Parties or their r espective Affiliates ; means Dr Thrasher and those members of the researc h group led by Dr Thrasher working under the direction and supervisio n of Dr Thrasher at his UCL laboratories from time to time, prior to, on or after the Effective Date, including the individuals set out at Schedule 7 und er the heading ; means ( i ) any entity which ( as a principal or prim ary aim of its business ) imports, develops, markets, sells or manufactures tobacco pr oducts ; and/or ( ii ) any entity which makes the majority of its profits from the importation, marke ting, sale or disposal of tobacco products and ( iii ) any entity directly Controlled by any entity within ( i ) or ( ii ) ; 12 means the clinical trial undertaken by UCL in resp ect of the ADA SCID Project under the clinical trial reference [ * * * ] ; means the clinical trial undertaken by [COMPANY] in res pect of the ADA SCID Project under the clinical trial reference [ * * * ] ; means Dr Kohn ; means Dr Thrasher and Dr Gaspar ; has the meaning at Clause 5.1.3 ; has the meaning at Clause 5.1.4 ; means MPS1 Know - how, Perforin Know - how, [ * * * ] and the LCR - EFS Know - how ; means ( i ) [ * * * ] ; means the [ * * * ] and any New Patents claiming any o f the UCLB Know - how ; means the LCR - EFS Platform IP, MPS1 IP, Perforin I P, [ * * * ], UCLB Patents, the UCLB Know - how, the UCLB Manufacturing Technology an d the Materials relevant to any of the Projects ( excluding the ADA SCID Project ) ; has the meaning set out at Recital ( E ) ; means a claim within ( i ) an issued or granted and unexpired Patent licensed hereunder ; or ( ii ) a pending application for a Patent licensed he reunder, which has not been pending for more than seven ( 7 ) years from the date of the priority filin g from which such pending application originates, a nd in each case of ( i ) and ( ii ) above, which has not been held unenforceable, unpatentable or invalid by a decision of a court or government body of competent jurisdiction, or where appealed within the time allowed for appeal has not been held unenforceable, unpatentable or invalid by an appellate body of competent jurisdiction ( including by the highest ap pellate court in the relevant jurisdiction where appealed to that court ), and which has not been wit hdrawn, cancelled, revoked, disclaimed, rendered unenforceable through disclaimer or otherwise, dona ted or dedicated to the public, Surrendered or deemed invalid by an interference or opposition pan el or court as part of any interference or oppositi on proceeding ; and means one of the ADA SCID Vector, LCR - EFS Vector, MPS1 Vector, Perforin Deficiency Vector or [ * * * ], and means two or more of the foregoing