definiens: means any Academic Organisation which is actively collaborating with UCL or [COMPANY] on Academic Research as permitted in accord ance with the provisions of this Agreement ; means an organisation engaged in the conduct of ac ademic research or the non - commercial funding of academic research, compri sing academic institutions, charities, not - for - prof it organisations and government bodies including the n ational health services and equivalent organisation s throughout the world ; means academic research ( excluding clinical resear ch ) which is undertaken by either or both of UCL or [COMPANY] alone, together, or i n collaboration alone or jointly with another Academic Organisation ; means severe combined immunodeficiency disease in humans caused by an inherited deficiency in adenosine deaminase ; means the Joint Patents, the Joint Know - how, Joint Clinical Data, and all IP in the Joint Materials ; means any gene therapy products or therapies Explo ited by Orchard, or any of its Sub - licensees pursuant to a sub - licence granted her eunder, which is labelled, approved or otherwise marketed by Orchard and/or its Sub - licensees for th e ADA SCID indication and ( i ) which would, were it not for the existing licence to the Joint Patents h ereunder, infringe a Valid Claim of any Joint Paten t in the country of sale of such product ; and/or ( ii ) in which final product, the ADA SCID Vector 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 Joint Know - how or Joint Clinical Data ; 2 means the program of research defined in Part A of Schedule 1 as has been overseen by or conducted by any one or more of the Research Groups prior to the Effective Date togethe r with the UCL ADA SCID Clinical Trial and the [COMPANY] A DA SCID Clinical Trial ; means the vector defined in Part A of Schedule 1, together with such vector incorporating minor modifications thereto provided that the Joint Clinical Data will support approval of such modified vector ; in relation to a Party, means any entity or person that Controls, is Controlled by, or is under common Control with that Party . For the purposes of this Agreement, ( i ) UCL shall be deemed an Affiliate of UCLB and vice versa ; and, ( ii ) Orchard ’s Affiliates shall be limited to its subsidiaries ( as defined in section 1159 of the Companies Act 2006 ) from time to time ; means this agreement together with its schedules, each as may be amended, varied or extended from time to time in accordance with the t erms of this Agreement ; means advanced therapy medicinal products ; means all demands, claims and liability ( whether c riminal or civil, in contract, tort or otherwise ) for losses, damages, awards, costs and e xpenses of any nature whatsoever and all costs and expenses ( including legal costs ) incurred in connec tion therewith ; means any and all test data, test designs and prot ocols, results and data from human clinical studies, including data submitted as part of Regulatory Submissions or in support of applicat ions for Regulatory Incentives, but for the avoidance of doubt Clinical Data does not include the original physical subject medical records and other physical source documents ( as that term is defined in ICH E 6 section 1.52 ), but does include the data and inform ation therein ; means making regulatory filings for the purpose of obtaining and maintaining Regulatory Approvals ; or means an agreement pursuant to which clinical trial activities are to be undertaken ; means any research ( i ) that is, in whole or part, funded by a person or entity that is not an academic, charitable or not - for - prof it organisation ; or ( ii ) that is undertaken at the request of or for the benefit of any entity that is not an Academic Organisation involved in such research ; or ( iii ) that is undertaken ( as opposed to funded ) in collaboration with any entity which is not an Acade mic Organisation ; or ( iv ) under which a Third Party, wh ich is not an Academic Organisation participating i n such research, will acquire any rights in ( includin g by way of option, assignment or licence ) or contr ol over the results of such research ; means all Know - how, trade secrets, information and all other technical or commercial information that : a ) in respect of information provided in documentar y or written form or by way of a model or in other media or tangible form or a form not covered by ( b ) below, at the time of provision is marked or otherwise designated or identified that it is impar ted in confidence or which a reasonable person would expect to be confidential ; and, 3 b ) in respect of information that is imparted orall y, visually or otherwise by way of demonstration th e Disclosing Party or its representatives informed th e Receiving Party at the time of disclosure, or which a reasonable person would expect, to be confi dential ; or means direct or indirect beneficial ownership of m ore than 50 % ( or, outside a Party ’s home territory, such lesser percentage as is the maximum permitted level of foreign investme nt which still provides control over the day to day ma nagement and direction of the Party ) of the share capital, stock or other participating interest carr ying the right to vote for the election of director s or cause the direction of the management of policies of any entity, as the case may be ; means exerting those efforts as would normally, re asonably and fairly be exerted or employed by a Third Party company of equivalent res ource and establishment for a product of similar market potential and at a similar stage of its prod uct life, having reasonably assessed the likelihood of a successful approval, having regard to the duration to market, additional development and research cost s, Third Party IP costs and risks and the likely econo mic return and duration ; has the meaning given in Clause 10.1.1 ; means the letter described as such, dated as of the date of this Agreement and addressed by UCLB and [COMPANY] to Orchard ; has the meaning given in Clause 2.7.4 ; means all papers, books, records, files, documenta tion, laboratory note books and other physical records, including in resp ect of Regulatory Submissions and Regulatory Incentives, relevant to, recording, disclosing or i ncorporating any of the Technology, including those set out in Schedule 5 ; means the date that Orchard issues to UCLB the 5,12 5,000 ( five million one hundred and twenty five thousand ) Ordinary Shares in Orchar d in accordance with its obligations under Clause 5.2.2 which will not be later than 12 February 2016 ; means the European Medicines Agency or any successo r agency thereto ; means ( i ) in the case of UCLB its Managing Director ; ( ii ) in the case of [COMPANY] its Senior Director of Licensing ; and ( iii ) in the case of Orchard its chief executive officer ; and means to make, have made, import, export, use, sell or offer for sale, including to research, experiment, develop, commerc ialise, obtain and maintain Regulatory Approvals, manufacture, have manufactured, hold or keep ( wheth er for disposal or otherwise ), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of, and shall mean the act of Exploiting ; means the US Food and Drug Administration or any su ccessor agency thereto ; means all uses and applications without restrictio n ; 4 means the first anniversary of the date of a Market ing Approval granted to Orchard, or any Sub - licensee pursuant to a sub - lice nce granted hereunder, in respect of a Gene Therapy Product in any country in the Territory ; means the first arm ’s length commercial sale of th e applicable Gene Therapy Product in a country by Orchard or by a Sub - license e pursuant to a sub - licence granted hereunder, in each case following the grant of a Marketing Approv al for the applicable Gene Therapy Product in such country ; means Dr Gaspar and those members of the research g roup led by Dr Gaspar working under the direction and supervision of Dr Gaspar at his UCL laboratories from time to time, prior to, on or after the Effective Date, inc luding the individuals set out at Schedule 7 under the heading ; means one of an ADA SCID Product, an LCR - EFS Platf orm Product, an MPS1 Product, a Perforin Deficiency Product or a [ * * * ] Product, and means two or more of the foregoing ; means good manufacturing practices ; means the exercise of an appropriate degree of ski ll, care, prudence, efficiency, foresight and timeliness as would be ex pected from a start - up company within the gene therapy or biotechnology sector ; has the meaning given in Clause 2.7.1 ; means ( a ) any improvement, enhancement, development or ad vancement ( together with all Intellectual Property Rights in the same ) over any of the Technology and which if Orchard or its Sub - licensees used, deploye d or incorporated in or for the Exploitation of any p roduct ( including its development or manufacture ), process or service, would ( either alone or where us ed with any of the Technology ) result in such produ ct, process or service being within ( i ) a definition of a Gene Therapy Product ; and/or ( ii ) the scope of o r otherwise dependent upon ( that is, in each case, in the absence of any licence, would otherwise infrin ge ) any one or more claims of any of the Joint Patents and/or UCLB Patents ; and ( b ) any other improvement, enhancement, development or advancement ( together with all Intellectual Property Rights in the same ) over any of the Techno logy which if Orchard or its Sub - licensees used, deployed or incorporated in or for the Exploitation of any product ( including its development or manufacture ), process or service would result in su ch product, process or service being dependent upon and not otherwise severable from some, if not all, of the Technology ; in each case, as is created after the Effective Dat e and excluding all such improvements, enhancements, developments and advancements under an SRA or CTA t o which Orchard is a party and under which Orchard receives a sub - licensable ( through multiple tiers ), assignable worldwide licence that is exclu sive in the field of Gene Therapy Products and otherwise non - exclusive throughout the remainder of the Field ; has the meaning given to it at Clause 9.7 ; means ADA SCID, MPS1, Perforin Deficiency, and [ * * * ] and means any one of the foregoing ; 5 or or means all Patents, claims in or rights to Patents, rights in designs ( including design patents, registered de signs and unregistered designs ), copyright, rights in software, database rights, rights in data, inventio ns, rights in Know - how, trade secrets and confident ial information, and any and all other similar rights o r equivalent rights to any of the foregoing situate d in any country in the world, in each case for their fu ll term and any extensions, together with applicati ons for any of the foregoing, the right to apply for an y of the foregoing in any part of the world and the right to claim priority in respect of any of the foregoin g ; means the agreement between UCLB and [COMPANY] dated on or about the date of this Agreement in respect of the arrangemen ts and profit sharing between UCLB and [COMPANY] related to the Joint UCLB / [COMPANY] Technology, a copy o f which has been disclosed to Orchard prior to the Effective Date ; means all the Clinical Data generated or derived f rom or in pursuit of each of the UCL ADA SCID Clinical Trial and [COMPANY] ADA SCID Clini cal Trial, including the data described in Part D of Schedule 1 ; means use for preparing, filing and prosecuting Re gulatory Submissions and for obtaining and maintaining Regulatory Approv als ; means : ( a ) Know - how in inventions claimed in the Joint Pat ent ; ( b ) the Know - how listed and identified in Part C of Schedule 1 ( the Know - how at ( a ) and ( b ) being the ) ; and ( c ) all other Know - how beyond the Principal Joint K now - How ( including other Know - How disclosed in the Joint Patent ) existing as of the Effective Date that was ( i ) created, generated or developed from or in connection with the performance of the ADA SCID Pro ject by any member(s ) of any of the Research Groups, or ( ii ) used in connection with the ADA SCI D Project and which UCLB and/or [COMPANY] are free, as of the Effective Date, to license to Orchard but in each case excluding any Joint Clinical Data ; means the Materials generated and/or developed purs uant to the ADA SCID Project by any member(s ) of any of the Research Groups, and Materials that were used in connection with the ADA SCID Project and which UCLB and/or [COMPANY] are fre e, as of the Effective Date, to license to Orchard, together with the ADA SCID Vector and thos e other Materials listed under Part E of Schedule 1 ; means the Patent set out in Part B of Schedule 1 an d all Patents derived therefrom ; means the ADA SCID IP and the Joint Materials ; means all technical and other information, knowled ge, ideas, concepts, discoveries, data, designs, know - how, trade secrets, inventions ( which at the relevant time are not the subject of a Pate nt ), formulae, methods, software sequences, models, proc edures, designs for experiments, trials and tests a nd results of the same, testing methods, processes, sp ecifications and techniques, pre - clinical data, cli nical data and manufacturing data including all Clinical Data ; 6 means ( i ) for all purposes other than the definiti ons of ADA SCID Project, Joint Know - how and Joint Materials, Dr Kohn and emp loyees under his supervision as of the Effective Date who have been informed of [COMPANY] ’s obligations u nder this Agreement ; or ( ii ) for the purposes of the definitions of ADA SCID Project, Joint Know - how and Joint Materials, Dr Kohn and those members of the research group led by Dr Kohn working under the direction and supervision of Dr Kohn at his [COMPANY] laboratories from time to time, prior to and / o r as of the Effective Date, including the individua ls set out at Schedule 7 under the heading ; means ( i ) the Patents listed and identified under t he title Scheduled LCR - EFS Patents in Part A of Schedule 2 and any Patents ari sing therefrom ( ) ; ( ii ) all Know - how in inventions claimed in the LCR - EFS Patents ; ( iii ) all Know - how listed and identified under the title LCR - EFS Know - how in Part A of Schedule 2 ( the Know - how at ( ii ) and ( iii ) being the ) ; ( iv ) all Know - how ( beyond the Principal LCR - EFS Know - How ) existing as of the Effective Date that was ( a ) created, generated or developed from or in connection with the LCR - EFS Platform Project, and/or ( b ) used in connection wit h the LCR - EFS Platform Project, and/or otherwise disclosed in the LCR - EFS Patents, and which UCLB is free, as of the Effective Date, to license to Orchard, ( ( ii ), ( iii ) and ( iv ) together being the ) ; ( v ) any New Patents claiming any of the LCR - EFS Know - how ; and ( vi ) all IP in the Materials used in connection with the LCR - EFS Platform Project and which UCLB is free, as of the Effective Date, to license to Orchard, and otherwis e in Materials generated and/or developed pursuant to the LCR - EFS Platform Project, together with the LCR - EFS Vector and those other Materials listed und er Part A of Schedule 2 ; means any gene therapy products or therapies, excl uding any ADA SCID Product, MPS1 Product, Perforin Product or [ * * * ] Product Exploited by Orchard, or any of its Sub - licensees pursuant to a sub - licence granted her eunder, ( i ) which would, or the Exploitation of whi ch would, were it not for the existing licence to the LCR - EFS Platform IP hereunder, otherwise infringe a Valid Claim of any Patents included in the LCR - EFS Platform IP in the country of sale of such product ; ( ii ) in which final product, the LCR - EFS Vector 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 product, or t he manufacture of such product, or is incorporated in such product, any LCR - EFS Know - how ; means the program of research defined in Part A of Schedule 2 as has been overseen by or conducted by either or both of the Thrasher Research Group and Gaspar Research Group prior to the Effective Date ; means the vector defined in Part A of Schedule 2 to gether with any modifications and derivatives thereof resulting in a vector conta ining the LCR Sequences or any combination thereof ; means each of the beta globin gene hyper - sensitive sites sequences as defined in Part A of Schedule 2 together with modifications of each that result in an [ * * * ] homology with each site as defined in Part A Schedule 2 ; has the meaning at Clause 8.2.1 ; or means those Regulatory Approval(s ) required by appl icable laws and regulations in a particular country or territory in order to sell or commercially supply a medicinal p roduct and/or device in that country or territory ; means Physical Materials and Documentary Materials ; means the [ * * * ] ; 7 means the condition known as mucopolysaccharidosis I caused by an absence of, or insufficient levels of, the enzyme alpha - L - iduronidase ; 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 MPS1 Know - how in Part B of Schedule 2 ( the Know - how at ( ii ) and ( iii ) being th e ) ; ( iv ) all Know - how ( beyond the Principal MPS1 Know - How ) existing as of the Effective Date that was ( a ) created, generated or developed from or in connection with the MPS1 Pr oject, and/or ( b ) used in connection with the MPS1 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 MPS1 Kn ow - how ; ( v ) all IP in the Materials used in connection with the LCR - EFS Platform Project and which UCLB is free, as of the Effective Date, to license to Or chard, and in Materials otherwise generated and/or developed pursuant to the MPS1 Project, together wi th the MPS1 Vector and those other Materials listed under Part B of Schedule 2 ; 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 MPS1 in dication and ( i ) which would, were it not for the existing licence to the MPS1 IP hereunder, infringe a Valid Claim of any Patents included in the MPS1 IP ; ( ii ) in which final product, the MPS1 Vector 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 product, or t he manufacture of such product, or is incorporated in such product, any MPS1 Know - how ; means the program of research in respect of MPS1 d efined in Part B of Schedule 2 as has been overseen by or conducted by either or both of the Thrasher Research Group and Gaspar Research Group prior to the Effective Date ; means the vector defined in Part B of Schedule 2 to gether with any modifications and derivatives thereof that result in [ * * * ] Vector tar geting MPS1 ; means : a ) the gross invoiced price of Gene Therapy Product s sold by Orchard or its Sub - licensees ( or their respective agents ) to a Third Party on an arm ’s len gth transaction for the sale of the Gene Therapy Product for a cash consideration ; and/or b ) where a sale or disposal of Gene Therapy Product s by Orchard or its Sub - licensees ( or their respective agents ) to a Third Party is other than i n accordance with ( a ) above [ * * * ] ; after deduction of all documented : i ) [ * * * ] ; ; ii ) [ * * * ] ; iii ) [ * * * ] ; iv ) [ * * * ] ; v ) [ * * * ] ; vi ) [ * * * ] ; and 8 vii ) [ * * * ]