definiens: has the meaning given to it in paragraph 1.8 of Schedule 1 ; Current Good Manufacturing Practice as defined in ( i ) the Federal Register volume 66No 186 and those sections applicable within the FDA Regulations 21 CFR Part 210,211, 600, 601 and 610 and ( ii ) the rules governing medicinal products in the EuropeanUnion . Volume 4 – Guidelines for good manufacturing practices for medicinalproducts for human and veterinary use . Part II – Basic Requirements for ActiveSubstances used as Starting Materials and ICHQ7 and ( iii ) any similar UK specificregulations potentially coming into force after 19 March 2019 ; has the meaning given to it in clause 0 ; has the meaning set out in clause 8.1 ; with respect to the activities pursuant to a Program, the reasonable efforts andresources used by a reputable biopharmaceutical contract manufacturing organizationfor drug substances of similar nature, complexity and developmental stage in thesame or similar circumstances ; the fact and terms of this Agreement and all information ( in whatever form ) in respectof the business of each of the Parties and each of its Affiliates including any ideas;business methods ; finance ; prices, business, financial, marketing or developmentplans ; products or services, know - how or other matters connected with products orservices manufactured and/or marketed ; customer lists or details ; computer systemsand software ; which is ( in each case ) provided or obtained by one Party to or for theother ; a Batch of Product which has been produced in accordance with cGMP and whichmeets the Product Specification and a Batch of Intermediate Product [ * * * ] which hasbeen produced in accordance with cGMP and which meets the [ * * * ] ReagentSpecification or the Intermediate Product Specification, as applicable ; [COMPANY] [COMPANY] Commercial Supply Agreement 2 a consumable item used or intended for use in a Program, being one supplied byFujifilm, including [ * * * ] ; ( a ) any power ( whether directly or indirectly and whether by the ownership of sharecapital, the possession of voting power, contract or otherwise ) to appoint and / orremove all or such of the members of the board or other governing body of abody corporate as are able to cast the majority of the votes capable of beingcast by members of that board or body on all, or substantially all, matters, orotherwise to control or have the power to control the policies and affairs of thatbody corporate ; or ( b ) the holding and/or possession of the beneficial interest in and/or the ability toexercise the voting rights applicable to shares or other securities in any person(whether directly or indirectly ) which confer in aggregate on the holders thereto50 % or more of the total voting rights exercisable at general meetings of thatbody corporate on all, or substantially all, matters, and and shall be construed accordingly ; the deliverables to be supplied by the Customer listed in Schedule 4 ; all Foreground IP that constitutes an improvement or modification which [ * * * ] to theCustomer ’s Background IP [ * * * ] ; [COMPANY] equipment in the Facility that is dedicated to the Customer ; a cGMP deviation as detailed in the Quality Agreement ; the part of the Program during which ( i ) the Product or [ * * * ] or Intermediate Product istested for compliance versus the Product Specification ; ( ii ) all production instructionand analytical records relating to cGMP manufacture of each Batch prepared byFujifilm are reviewed ; and ( iii ) a [COMPANY] recommendation for Product release or rejectis made ; in each case as applicable ; the final dosage form of product which contains Product in association with otheractive or inactive ingredients [ * * * ] ; [COMPANY] [COMPANY] Commercial Supply Agreement 3 the date of signature by all Parties to this Agreement ; any of [COMPANY] ’s manufacturing facilities in which a Program will be performed ; any event or circumstances outside the reasonable control of a Party affecting itsability to perform any of its obligations under this Agreement including act of God, fire, flood, severe weather, epidemic or pandemic, war, revolution, acts of terrorism, riot or civil commotion, acts of government, trade embargo, labour disputes(excluding labour disputes involving the Party in question ), interruption of utilityservice, restraints or delays affecting shipping or carriers, ( where proper precautionshave been taken by the party suffering the event or circumstance ) inability or delay inobtaining supplies of adequate or suitable materials, ( where proper precautions havebeen taken by the party suffering the event or circumstance ) breakdown or failure inequipment or machinery, ( where proper precautions have been taken by the partysuffering the event or circumstance ) cyber - attack, currency restrictions, and illnessaffecting a material number of the Program team, but shall not include the failure ofDrug Product in clinical trials or failure of Drug Product to gain, or loss of, regulatoryapproval ; has the meaning given to it in paragraph 2.1 of Schedule 2 ; all Intellectual Property Rights that arise or are obtained or developed by or on behalfof either Party in the course of the performance of a Program ; all Foreground IP [ * * * ] ; has the meaning given to it in paragraph 2.1 of Schedule 2 ; shall mean any national or international health authority including but not limited tothose of the European Union, and the United States ; on demand to indemnify and keep indemnified, and hold harmless, the Party to beindemnified on an after tax basis ; the period from the Effective Date until 31 December in the year in which the fifthanniversary of the Launch Date falls ; [COMPANY] [COMPANY] Commercial Supply Agreement 4 any current and future intellectual property rights and interests including patents, utility models, designs, design rights, copyright ( including rights in software),decryption rights, database rights, trade marks, rights pursuant to passing off, service marks, business and trade names, domain names, know - how, results, data, databases, formulations, compounds, rights in biological or chemical materials, rightsunder data exclusivity laws, rights under unfair competition laws, topography rights, inventions, rights in confidential information ( including technical and commercial tradesecrets ) ; supplementary protection certificates and image rights, and rights of asimilar or corresponding character in any part of the world, in each case whetherregistered or not and including any application for registration and renewals orextensions of such rights in any country in the world and whether subsisting now or inthe future ; a Batch of an Intermediate Product that is produced from a run of the [ * * * ] intermediate element of the Process;“Intermediate Products [ * * * ] the recombinant human growth hormone ( hGH ) produced as part of [ * * * ] ; has the meaning given to such term in clause 5.8.4 the committee formed and operated by the Parties, which shall act in resolvingdisagreements and disputes between the Parties, discuss and evaluate the mutualcooperation and in good faith negotiate and decide upon issues ; the key assumptions set out in part 2 of Schedule 2 ; a key performance indicator agreed by the Joint Steering Committee pursuant toclause 3.2.7 ; the date the Drug Product is first made available by the Customer in any country forsale as an approved drug for the treatment of patients ; any ( i ) liabilities whether in contract, tort ( including negligence ) or otherwise;(ii ) losses, costs ( including internal costs / overheads ), damages, fines or expensesincluding reasonable legal fees ; and ( iii ) claim, demand, proceeding, action or causeof action ; in each case howsoever arising . shall be construed accordingly ; has the meaning given to it in clause 7.1 ; as set out in Schedule 2 ; as set out in Schedule 2 ; a Batch which has not been produced in accordance with cGMP and/or does notmeet, as appropriate, the Product Specification or the [ * * * ] Specification or theIntermediate Product Specification ; [COMPANY] [COMPANY] Commercial Supply Agreement 5 has the meaning given to it in Schedule 2 ; has the meaning given to it in Schedule 1;”PPQ ” Process Performance Qualification the particular process used, or to be used, for manufacture of the Product or the [ * * * ] Reagent, as applicable ; the Process specification which is a QA Document ; TransCon [ * * * ] human growth hormone ( hGH ) ; the Product specification which is documented in a QA Document ; a period of twelve ( 12 ) consecutive calendar months ending on 31st December, thefirst Production Year commencing [ * * * ] ; the production, testing and Disposition ( if applicable ) of Batches including pre andpost manufacturing activities ( such as campaign set up and Facility change - over ) tobe performed under this Agreement ; the Program manager appointed by each of [COMPANY] and the Customer under clause3.1 ; the single document agreed by the Parties which sets out the mutually agreed qualitystandards applicable for the cGMP manufacture of the Products, IntermediateProducts, and [ * * * ] Reagent, including documentation requirements, notification, sampling, testing, rejections, complaints handling, deviation handling, CAPAs, change control, reporting and recall mechanisms ; the Quality Agreement and the documents produced and approved in accordancewith the Quality Agreement ; has the meaning given to it in clause 9.6 ; the U.S. Food and Drug Administration, the European Medicines Agency, theMedicines & Healthcare products Regulatory Agency and any successor to any suchentities ; work subcontracted by [COMPANY] under clause 21.3 ; the shelf life of Materials, detailed in the Storage Agreement ; [COMPANY] [COMPANY] Commercial Supply Agreement 6 the terms and conditions for storage of [ * * * ] Reagent, the Intermediate Products ( tothe extent [ * * * ] ) and Product, set out in Schedule 5 ; value added tax, sales tax or any other similar type of turnover tax ; worldwide the [ * * * ], known as [ * * * ] ; the Process specification for the [ * * * ] Reagent, which is documented in a QADocument ; and each period of 12 ( twelve ) consecutive months commencing on the Effective Dateor an anniversary of the Effective Date, the final last Year commencing on the lastanniversary of the Effective Date and ending on the date of termination or expiry