Certain information contained in this exhibit, identified by [***], has been omitted pursuant to Item 601(b)(2)(ii) or 601(b)(10)(iv) of Regulation S-K, as applicable, because it is both not material and is the type that the registrant treats as...
Certain information contained in this exhibit, identified by [***], has been omitted pursuant to Item 601(b)(2)(ii) or 601(b)(10)(iv) of Regulation S-K, as applicable, because it is both not material and is the type that the registrant treats as private or confidential.
Exhibit 4.20
DATED 23 JUNE 2021
(1) FREELINE THERAPEUTICS LIMITED
- and -
(2) CELL THERAPY CATAPULT LIMITED
THIS COLLABORATION AGREEMENT (the “Agreement”) is dated the May 2021 (the “Effective Date”)
BETWEEN
(1) |
Freeline Therapeutics Limited, a company incorporated and registered in England and Wales with company number 09500073 whose registered office is at Stevenage Bioscience Catalyst, Xxxxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxx XX0 0XX (“COLLABORATOR”); and |
(2) |
Cell Therapy Catapult Limited, trading as Cell and Gene Therapy Catapult, a company incorporated and registered in England & Wales with company number 07964711 whose registered office is at 12th Floor Tower Wing B, Guys Hospital, Xxxxxx, XX0 0XX, Xxxxxx Xxxxxxx (the “Catapult”). |
BACKGROUND
(A) |
Catapult’s purpose in operating the cell and gene therapy manufacturing centre is to further its broader aims within the UK to develop novel technologies, processes, supply chains, facilities, skills, and working practices for simultaneous and cost effective large-scale manufacture and distribution of multiple ATMP products. |
(B) |
COLLABORATOR is developing certain ATMP products. As part of this activity COLLABORATOR wishes to use the facilities at the Centre in order to develop manufacturing systems, technologies and capability for large scale manufacture of gene therapy products. |
(C) |
COLLABORATOR and Catapult have executed the Collaboration Agreement dated 10 April 2018 (“Agreement 1”). The term of Agreement 1 ends on 01 July 2021. |
(D) |
COLLABORATOR and Catapult would each like to collaborate with the other as further set forth in this Agreement (“Project” or “Collaboration”, as further described in the work streams set out at Schedule Error! Reference source not found.). |
(E) |
Other parties who collaborate with the Catapult and occupy the Centre in the same way will be referred to as “Other Collaborator(s)” (and together with |
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COLLABORATOR as “Collaborator(s)” or “All Collaborators”). Collaborators are not and will not be deemed to be the agents, visitors or subcontractors of Catapult for the purposes of this Agreement. |
(F) |
This document aims to record the inputs and financial contributions of each Party with respect to this Agreement, and the terms under which COLLABORATOR and Catapult will work together within the Centre. |
OPERATIVE PROVISIONS
1.1 |
In this Agreement, the following words will have the following meanings: |
“Accompanied Access Areas” |
means the areas of the Centre marked yellow on the Plans which are accessible by All Collaborators, but on condition such access is in the company of Catapult personnel. |
“Activity Related Inputs” |
means the inputs provided by Catapult set out at Clause 9.2. |
“Activity Related Input Contributions” |
means the financial contribution made by COLLABORATOR with respect to the provision of the Activity Related Inputs, and as described in Clause 8.3.3. |
“Additional Inputs” |
means inputs COLLABORATOR requires Catapult to contribute to the Project, other than Activity Related Inputs and Integral Inputs, which will be arranged through the completion of an Additional Input Agreement in the form set out at Schedule Error! Reference source not found. (“Additional Input Agreement”). |
“Affiliate” |
in relation to a Party, means any person that Controls, is Controlled by, or is under common Control with that Party. |
“Applicable Law” |
means any: (a)statute, statutory instrument, by-law, order, regulation, directive, treaty, decree, decision of the European Council or law; (b)legally binding rule, policy, guidance or recommendation issued by any governmental, statutory or regulatory body with jurisdiction over this Agreement or the activities conducted hereunder; and/or (c)legally binding industry code of conduct or guideline; which applies to this Agreement and/or the Inputs and/or the activities which are comprised in the Project. |
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“Background Intellectual Property” |
(a)in relation to COLLABORATOR, means the Intellectual Property that is either (i) owned by or licensed to COLLABORATOR prior to the Effective Date, or (ii) that is developed or licensed by COLLABORATOR on or after the Effective Date and outside of the conduct of activities for the Project; and in the case of either (i) or (ii), that COLLABORATOR uses in the performance of the Project, other than Foreground Intellectual Property; and (b)in relation to Catapult, means the Intellectual Property owned by or licensed to Catapult prior to the Effective Date, together with Intellectual Property that is developed by or licensed to Catapult on or after the Effective Date and outside of the conduct of activities for the Project; and in either case that Catapult uses in the performance of the Agreement, and that is not Foreground Intellectual Property. As of the Effective Date, to Catapult's knowledge and belief, Catapult’s Background Intellectual Property consists of Intellectual Property falling within the areas described in Schedule Error! Reference source not found.. |
“Business Rates Contribution” |
has the meaning given in Clause 8.3.3. |
“Catapult Compensations” |
has the meaning given to it in Clause 18. |
“Catapult SOPs” |
Catapult’s standard operating procedures for the Centre from time to time. |
“Centre” |
means the Cell and Gene Therapy Catapult Manufacturing Centre located at Xxxxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxx, XX0 0XX. The Centre outlines are edged in blue on the Plans. |
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“CNC corridor” |
means the controlled non-classified corridor forming part of the Common Access Areas. |
“Code of Conduct” |
means the code of conduct set out at Schedule Error! Reference source not found.. |
“Collaborator Forums” |
means the Quality Forum, the Health and Safety Forum, and the Operational Forum, each as more particularly referenced, and described in Clause 9.6 and Schedule Error! Reference source not found.. |
“COLLABORATOR Manufacturing Process”
|
means the process to be developed and operated by COLLABORATOR under the Agreement in order to enable the production of COLLABORATOR Product on a large scale as more particularly defined prior to signature of this contract in the Product Overview Document. It may be amended from time to time in accordance with Clause 7.2 and the QTA. |
“COLLABORATOR Personnel” |
means the employees or contractors of COLLABORATOR (including personnel of any of COLLABORATOR’s Third Party contractors) located at the Module from time to time. |
“COLLABORATOR Product” |
means COLLABORATOR owned and developed product, or products, to be produced on a large scale through the creation and adoption of COLLABORATOR Manufacturing Process. |
“COLLABORATOR Responsibilities” |
means the obligations on COLLABORATOR set out in Clause 10 (each one severally being a “COLLABORATOR Responsibility”). |
“Commissioning” |
has the meaning given in Clause 6.1. |
“Common Access Areas” |
means any part of the Centre shown edged green on the Plans which does not form part of the Module, the Restricted Access Areas, the Shared Restricted Access Areas or the Accompanied Access Areas, or that is designated by Catapult from time to time for common use by Catapult, and All Collaborators from time to time. |
“Conducting Media” |
means any media for the transmission of Supplies. |
“Confidential Information” |
means any information in any form or medium disclosed by one Party or such Party’s Affiliates, or their legal counsel, advisors, contractors (the “Disclosing Party”) to the other Party or its Affiliates, or their legal counsel, advisors, contractors (the “Receiving Party”) or to which either Party gains access as a result of COLLABORATOR’s occupancy of the Module and Centre or Catapult or Third Party’s use of the Centre at any time, or as a result of participation in any of the Collaborator Forums, concerning the business affairs, finances, technology, plans, strategy, products, manufacturing services, Know-how or services of (i) the Disclosing Party, (ii) any of its Affiliates, (iii) any other entity with which the Disclosing Party or any of its Affiliates is in business negotiations or has contracted or to which it owes a duty of confidence, or (iv) any Other Collaborator ((iv) being an “Alternative Disclosing Party”), and all copies of the same. Confidential Information also includes any information disclosed by either Party under the terms of any pre-existing confidentiality agreement between the Parties that has not expired as of the Effective Date (the “Pre-Existing CDA”). |
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“Contributions” |
means the Business Rates Contribution, Reservation Contribution, Risk and Capital Contribution, Facility Contribution, Integral Input Contributions, Establishment Input Contributions, Activity Related Input Contributions, the Additional Input Contributions and/or any other financial contributions as agreed in writing between the Parties and provided by COLLABORATOR to Catapult from time to time. |
“Control” |
means (a) the direct or indirect ownership of fifty percent (50%) or more of the total voting power of securities or other evidences of ownership interest in a party or (b) the power to direct or cause the direction of the management and policies of such party, directly or indirectly, whether through ownership of voting securities, by contract or otherwise; and the terms “controlling” and “controlled” have meanings correlative to the foregoing, as the case may be. |
“Disclosing Party” |
has the meaning given in the definition of “Confidential Information”. |
“Effective Date” |
has the meaning given in the preamble of this Agreement. |
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“Establishment Inputs” |
means the inputs provided by Catapult set out at Clause 9.3. |
“Establishment Input Contributions” |
means the financial contributions payable in accordance with Clause 8.3.5, to be made by COLLABORATOR with respect to the provision of the Establishment Inputs by Catapult, which are detailed in the Establishment Input Statement. |
“Establishment Input Statement” |
means the Establishment Input Contributions Statement by and between Catapult and COLLABORATOR dated 22 January 2018 |
“Facility Contribution”
|
means the contribution to be made by COLLABORATOR with respect to the provision of the Module and other capital aspects, as more particularly described at Clause 8.3.2, and at Schedule Error! Reference source not found.. |
“Foreground Intellectual Property” |
means the results, technical information, knowledge, inventions, improvements, experience, materials and data developed and arising directly from and as a direct result of the Project, together with any Intellectual Property in such items. |
“Full Occupation” |
has the meaning given in Clause 8.3.4(c). |
“GMP” |
means good manufacturing practice, being the standard required to satisfy MHRA good manufacturing practice requirements. |
“GMP Requirements” |
means good manufacturing practices for medicinal products for human use as applicable in the UK (currently EU GMP Directive 2003/94/EC and as and set out in Volume 4 of Eudralex (the rules governing medicinal products in the European Union), and the MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide). |
“Ground Level” |
means the Xxxxx 0 Xxxxxx Xxxxx as shown on the Plans. |
“Health and Safety Forum” |
means the forum in which COLLABORATOR, Other Collaborators, and Catapult will convene to discuss health and safety matters as more particularly described in Clause 9.6 and Schedule Error! Reference source not found.. |
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“HVAC” |
heating, ventilation and air-conditioning. |
“Improvement” |
means, with respect to any Intellectual Property or material: (a) all improvements, modifications and/or adaptions of such Intellectual Property or materials; and (b) all other Intellectual Property in, derived from, relating to, or otherwise within the scope of any claim, right, or interest which would impair or restrict the use of, application, or rights comprised in, such Intellectual Property or material. |
“Insured Risks” |
means the risks covered by the policies of insurance under Clauses 19.1 and 19.2, in each case to the extent that cover is generally available on normal commercial terms in the UK insurance market at the time the insurance is taken out and any other risks against which Catapult reasonably insures from time to time, subject in all cases to any excesses, limitations and exclusions imposed by the insurers. |
“Integral Input Contributions” |
means the financial contribution made by COLLABORATOR with respect to the provision of the Integral Inputs, as more particularly described in Clause 8.3.4 and at Schedule Error! Reference source not found.. |
“Integral Input Costs” |
the costs of providing the Integral Inputs to All Collaborators in the Centre for a given Year as reasonably determined by Catapult. |
“Integral Inputs” |
the inputs provided by Catapult set out at Clause 9.1. |
“Intellectual Property” |
means any and all issued patents and patent applications, inventions, utility models, registered and unregistered trademarks and service marks, registered designs, unregistered design rights, domain names, trade or business names, copyright, database rights, rights in respect of confidential information, rights under data exclusivity laws, rights under licences, rights under orphan drug laws, property rights in biological or chemical materials, topography rights, Know-how, extension of the terms of any such rights (including supplementary protection certificates), applications for and the right to apply any of the foregoing registered property and rights, and similar or analogous rights anywhere in the world. |
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“IT Infrastructure” |
the information technology facilities in the Centre for use by COLLABORATOR and, where applicable, by Other Collaborators as more particularly described in Schedule Error! Reference source not found.. |
“Know-how” |
means unpatented technical information (including without limitation information relating to inventions, discoveries, concepts, methodologies, models, research, development, and testing procedures; the results of experiments, tests, and trials; manufacturing processes, techniques, and specifications; and quality control data, analyses, reports, and submissions) that is not in the public domain.
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“Lease” |
means a lease dated 1 October 2015 made between the (1) Stevenage Bioscience Catalyst and (2) Cell Therapy Catapult Limited. |
“Liability” |
means liability arising out of this Agreement, whether in contract, tort, misrepresentation, restitution, under statute or otherwise, including any liability under an indemnity contained in this Agreement. |
“Level 2” |
means the Level 2 as shown on the Plans. |
“Licence Period” |
means the Term. |
“MAL” |
means material airlock. |
“Manufacturing Office” |
means the manufacturing office space forming part of the Module, allocated for COLLABORATOR’s use in accordance with Clause 3, and more particularly described in Schedules Error! Reference source not found. and Error! Reference source not found.. |
“Manufacturing Space” |
means the manufacturing space forming part of the Module, allocated for COLLABORATOR’s use in accordance with Clause 3, more particularly described in Schedules Error! Reference source not found. and Error! Reference source not found.. |
“MHRA” |
means the UK Medicines and Healthcare Products Regulatory Agency. |
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“Permitted Use” |
means any activity strictly in connection with the performance of the Project. |
“Plans” |
means the plans of the Module allocated to COLLABORATOR under this Agreement, and of the Centre generally, attached to this Agreement at Schedule Error! Reference source not found., Part 4. |
“PrAL”
|
means product airlock. |
“Pre-Screen Questionnaire” |
means a questionnaire described at Schedule Error! Reference source not found. defining each potential new Collaborator’s Manufacturing Process and their product as part of the Collaborator selection phase. |
“Product Overview Document” or “POD” |
means a quality document defining the COLLABORATOR Manufacturing Process and COLLABORATOR Product. |
“Process Transfer” |
means an Establishment Input, and the practical transfer of COLLABORATOR equipment and processes into the Centre under the control and responsibility of COLLABORATOR as more particularly set out at Schedule Error! Reference source not found.. |
“Project” |
has the meaning given in Recital (D). |
“QTA Product List” |
means the list of COLLABORATOR Products included in the Product List in the QTA from time to time, which shall list each corresponding POD and shall specify which collaboration agreement such POD and COLLABORATOR Product applies to (in the event the Parties execute more than one collaboration agreement). |
“Qualification” |
has the meaning given to it in Clause 6.3. |
“Quality Forum” |
means the forum in which COLLABORATOR, Other Collaborators, and Catapult will convene to discuss quality matters connected with the Centre as more particularly described in Clause 9.6 and Schedule Error! Reference source not found.. |
“Quality Management System” or “QMS” |
means a collection of business processes and governance structures focused on consistently meeting applicable Regulatory Authority and GMP requirements. The Quality Management System is expressed as an organisational structure, policies, procedures, processes and resources needed to maintain compliance to Eudralex Vol 4, Chapter 1 that are set out in the Quality Technical Agreement, and encompass the contents of Schedule Error! Reference source not found. (Warehouse and Procurement Management Provisions), Schedule Error! Reference source not found. (Environmental Monitoring), Schedule Error! Reference source not found. (IT Infrastructure), Schedule Error! Reference source not found. (Module and Centre Specification). |
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“Quality Technical Agreement” or “QTA” |
means the agreement between the Parties dated 19th of April 2018 governing the quality aspects of the Centre that are comprised in the Quality Management System (as it may be amended from time to time).
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“Quarter” |
means a period of three months commencing on 1 January, 1 April, 1 July, or 1 October; and “Quarterly” shall be construed accordingly.
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“Receiving Party” |
has the meaning given in the definition of “Confidential Information”. |
“Registered Rights” |
means patents, registrable design rights, trademarks, and all other registered Intellectual Property.
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“Regulatory Authority”
|
means the competent authority for each country or for any relevant grouping of countries legally responsible for authorising the sale or supply of human pharmaceutical products in that country or group of countries.
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“Restricted Access Area(s)”
|
means the parts of the Centre accessible only by Catapult personnel marked in pink on the Plan. |
“Risk and Capital Contribution” |
means the financial contribution made by COLLABORATOR with respect to the provision of all Inputs except for the Facility Contribution and Business Rates Contribution, payable at a rate of [***] of each Contribution, as more particularly described in Clause 8.1, and at Schedule Error! Reference source not found.. The Risk and Capital contribution will remain fixed at the rate of [***] throughout the Term. |
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“Shared Restricted Access Area” |
means the areas shared between the Manufacturing Space and an adjacent manufacturing space belonging either to COLLABORATOR or to an Other Collaborator marked in turquoise on the Plans. |
“Supplies” |
means water, gas, air, foul and surface water, drainage, electricity, oil, telephone, heating, telecommunications, internet, data communications and similar supplies or utilities. |
“Steering Committee”
|
the representatives of the COLLABORATOR and Catapult appointed as set out in Clause 9.5. |
“Technology Transfer” |
means the transfer of COLLABORATOR’s existing production and/or manufacturing processes into the Module which is divided into On-boarding and Process Transfer. |
“Term” |
means the period specified in Clause 17.1. |
“Termination Date” |
means the date on which this Agreement expires or terminates for any reason.
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“Term Start Date” |
means July 01 2021, being the date on which COLLABORATOR will occupy the Manufacturing Space under the terms of the Agreement.
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“Third Party” |
means any person other than a Party or its Affiliates. |
“Warehouse and Procurement Management Provisions” |
means the standards and obligations relating to the management of the warehouse set out at Schedule Error! Reference source not found.. |
“UPS” |
means uninterruptable power supply. |
“Validation” |
means documenting the way in which the equipment, facility or system used in a ‘process’ will result in an output meeting its specifications and predetermined quality attributes.
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“Year” |
means the financial year ending 31 March. |
1.2 |
In this Agreement, unless otherwise specified: |
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1.2.1 |
references to Clauses and Schedules are to the clauses of, and schedules to, this Agreement; |
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1.2.2 |
headings are for convenience only and do not affect the interpretation of this Agreement; |
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1.2.3 |
references to a person includes a body corporate or unincorporated body, and references to a company includes any company, corporation or other body corporate, wherever and however incorporated or established; |
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1.2.4 |
unless the context otherwise requires, words in the singular will include the plural and vice versa; |
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1.2.5 |
references to approvals or notices being “in writing” or “written” will include email; |
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1.2.6 |
any reference to a statute or statutory provision is a reference to it as amended, extended, re-enacted and/or replaced from time to time; and |
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1.2.7 |
‘including’ means ‘including but not limited to’ and ‘include’ and ‘includes’ will be construed accordingly. |
The Parties will undertake the Project in accordance with the provisions of this Agreement.
Catapult permits COLLABORATOR to occupy the Module under the terms of this Agreement.
4. |
MODULE SPECIFICATION |
4.1 |
Catapult will ensure the Manufacturing Space will be in accordance with the specifications at Schedule Error! Reference source not found. Part A. |
4.2 |
Catapult will ensure the Manufacturing Office and Non-Manufacturing Office will be in accordance with the specifications at Schedule Error! Reference source not found. Part B. |
The Centre is a MHRA-licensed GMP-compliant facility comprising the facilities set out at Schedule Error! Reference source not found., Part C.
6. |
COMMISSIONING AND QUALIFICATION OF THE CENTRE |
6.1 |
In advance of the Term Start Date and subject to Clause 7, Catapult tested equipment, facilities and/or plant which is Catapult owned or controlled and installed, |
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in order to verify it functions according to its design objectives or specifications (“Commissioning”). |
6.2 |
Commissioning did not cover the formal qualification of manufacturing systems or manufacturing process equipment but will include the static and dynamic commissioning of the following: |
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6.2.1 |
the Building Management System (BMS); |
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6.2.2 |
the Quality Control Area HVAC |
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6.2.3 |
the electrical supply (single and three phase); |
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6.2.4 |
the boilers; |
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6.2.5 |
the chiller; |
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6.2.6 |
HVAC; |
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6.2.7 |
lighting – including emergency lighting; |
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6.2.8 |
back-up generator; |
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6.2.9 |
UPS systems; |
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6.2.10 |
door interlocks; |
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6.2.11 |
pharmaceutical grade gas supplies (air, oxygen, carbon dioxide and nitrogen); |
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6.2.12 |
CCTV; |
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6.2.13 |
fire alarm; |
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6.2.14 |
LN2 / Low level, temperature and oxygen monitors; |
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6.2.15 |
drainage; and |
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6.2.16 |
appropriate IT Infrastructure (including cable network, switches, and server rooms). |
6.4 |
Catapult has undertaken Formal Qualification (which includes installation qualification and operational qualification) concurrent with leveraging the output of facility Commissioning. Catapult carried out performance qualification subsequent to Catapult’s completion of Commissioning, installation qualification and operational qualification. Catapult only applied performance qualification to those Inputs, systems and items of equipment that Catapult identified as having direct impact on product quality according to a formal system level impact assessment. These include: |
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6.4.1 |
Manufacturing Space and all additional air locks HVAC |
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6.4.2 |
Warehouse HVAC |
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6.4.3 |
Environmental Monitoring System (EMS) and environmental monitoring equipment (viable air sampler, non-viable particulate monitors); Technical area HVAC |
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6.4.4 |
Carbon dioxide system |
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6.4.5 |
Nitrogen gas system |
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6.4.6 |
Liquid nitrogen system, storage tanks (Catapult will carry out PQ in conjunction with a Collaborator) and shared Controlled Rate Freezing equipment (COLLABORATOR will be responsible for their own cycle development and PQ) |
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6.4.7 |
Oxygen system |
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6.4.8 |
Compressed air system |
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6.4.9 |
Cold room, fridges, freezers (Catapult will carry out PQ in conjunction with COLLABORATOR) |
7.1 |
VALIDATION |
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7.1.1 |
Process Validation is entirely the responsibility of COLLABORATOR. |
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7.2.1 |
Catapult confirms that it approved the COLLABORATOR Product included in the QTA Product List. It further confirms that such approval of COLLABORATOR Product will remain valid during the Term on the condition that no amendments are made at a later stage. |
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7.2.2.1 |
COLLABORATOR must notify Catapult in writing of its application for the Product or Process Modification/Addition (the “Notification”); |
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|
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7.2.2.2 |
In response, Catapult will apply the principles under Clause 7.2.3. If the requested Product or Process Modification/Addition meets the requirements of these principles, and are therefore capable of introduction, Catapult will always endeavour to approve the earliest date feasible for introduction, allowing for logistical constraints, and the competing interests of Other Collaborators in existence at the time of request (the “Introduction Date”); and |
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7.2.2.3 |
Catapult will confirm the outcome of the application of the criteria in Clause 7.2.3 and, if applicable, of the Introduction Date in writing to COLLABORATOR as soon as it is able to from the date of notification under Clause 7.2.2.1, but in any event within 30 calendar days of receipt of Notification by Catapult. Where Catapult indicates that the Product or Process Modification/Addition will not be permitted, it will identify the reasons why such Notification has been refused. |
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7.2.3.1 |
The new or modified COLLABORATOR Product(s), and/or COLLABORATOR Manufacturing Process(es) meet the requirements of the QTA; |
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7.2.3.2 |
The proposed product(s) is/are not a restricted product listed at Clause 7.2.3.7; |
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7.2.3.3 |
It does not affect Catapult’s ability to comply with GMP or GMP Requirements; |
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7.2.3.4 |
It does not compromise the safety of the Centre, or that of any Other Collaborator; |
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7.2.3.5 |
It does not place an additional, unreasonable demand on the resources of Catapult personnel and their ability to operate the Centre; |
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7.2.3.6 |
It does not interfere with the Catapult’s, COLLABORATOR’s, or any Other Collaborator’s compliance with their respective legal duties; and/or |
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7.2.3.7 |
It can be accommodated in the Centre, taking into account the overall capacity of the Centre. |
7.3 |
RESTRICTED PRODUCTS |
COLLABORATOR will not be permitted, and Catapult undertakes that it will not allow any Other Collaborator to produce or utilise in their process the following products in the Centre (unless prior agreement is sought from All Collaborators by Catapult):
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• |
B Lactam Antibiotics; |
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• |
Other highly sensitising antibiotics; |
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• |
Pathogenic Organisms (Containment Level 3 or 4); |
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|
• |
GMO 3 and above; |
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• |
Radiopharmaceuticals; |
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• |
Ectoparasiticides; or |
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• |
Sources of ionising radiation (but excluding low energy laboratory scale X-irradiators which have been assessed and approved by Catapult). |
8.3 |
COLLABORATOR will pay to Catapult the following contributions to the costs of the Collaboration: |
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8.3.1 |
subject to Clauses 8.1 to 8.2, from the Term Start Date, the Facility Contribution, payable [***] in advance; |
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8.3.3 |
the Activity Related Input Contributions as the costs of providing the Activity Related Inputs as they are incurred by COLLABORATOR; |
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(b) |
COLLABORATOR’s Integral Input Contribution from the Term Start Date until 31 March 2022 will be equivalent to [***] of the annual Integral Input Contributions payable by each of the Other Collaborators for the Year commencing 1 April 2021, subject to adjustment for: [***]. |
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(d) |
For each Year when Catapult anticipates less than ten (10) modules being occupied concurrently throughout such Year then this will be a Year which Catapult anticipates the Centre being outside Full Occupation. From and including the Year commencing 1 April 2022, for each Year which Catapult anticipates the Centre being outside Full Occupation (an “Anticipated Non-Full Occupation Year”), prior to the start of each such Year Catapult will reasonably estimate the Integral Input Costs to operate the Centre based on [***]. Following Catapult’s determination that it anticipates that the Centre will be outside Full Occupation for a given Year, it will determine whether the aforementioned Integral Input Contribution calculation method (i) or (ii) shall apply for such Year, and it shall notify All Collaborators accordingly. |
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8.3.6 |
All Contributions payable by COLLABORATOR to Catapult pursuant to this Agreement will be payable within thirty (30) days of receipt of an invoice by COLLABORATOR for such Contributions. |
8.4 |
By being part of the Centre, COLLABORATOR has access to the wider Catapult supporting infrastructure which includes reimbursement support, clinical trial support, process development capability, and regulatory and market access consultancy |
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expertise. The cost of such supporting inputs are to be agreed through separate negotiation and contractual agreement. |
8.6 |
At the beginning of each Year during the Term Catapult will provide to All Collaborators a budget setting out all anticipated Contributions for the Year with respect to Integral Inputs and Activity Related Inputs to be provided in that Year. In addition to this, from the date Full Occupation is achieved, a quarterly statement will be provided to All Collaborators in the Centre comparing actuals to the budgeted amounts. |
The operation of the Centre is dependent on a range of inputs split between:
(i) Integral Inputs are inputs Catapult, using its reasonable judgment considers as fundamental to the operation of the Centre and that All Collaborators will draw on, but not necessarily in equal measure. Integral Inputs may be varied from time to time by Catapult, after prior discussion and consideration of concerns raised by COLLABORATOR and Other Collaborators in the Operational Forum, in order to cater for the common, but not necessarily universal requirements of the COLLABORATOR and Other Collaborators in the Centre. Where COLLABORATOR’s utilisation of Integral Inputs is materially in excess of COLLABORATOR’s proportional contribution, COLLABORATOR shall be required to increase its proportional contributions to reflect its increased utilisation of Integral Inputs.
(ii) Activity Related Inputs are inputs that are dependent on COLLABORATOR Manufacturing Process and activity.
It is a condition of the Collaboration that the Integral Inputs, Establishment Inputs and Activity Related Inputs will be procured through Catapult.
(iii) Additional Inputs are inputs COLLABORATOR requires Catapult to contribute to the Project. These will be arranged, as needed, through the completion of an Additional Input Agreement in the form set out at Schedule Error! Reference source not found. (“Additional Input Agreement”). Once signed by both Parties, the Additional Input Agreement will serve to add further Inputs to this Agreement or amend the Additional Inputs in this Agreement as applicable, and an Additional Input will be deemed appended to the list of Additional Inputs at Clause 9.4 and any associated contributions from COLLABORATOR in consideration of the Additional
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Inputs will be deemed as having been inserted at Schedule Error! Reference source not found..
(iv) Establishment Inputs which are activities to be performed by Catapult, in conjunction with COLLABORATOR, to support the introduction of any new Collaborator Product and Process.
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9.1.1 |
the Quality Management System and supporting quality assurance function assuring all GMP inputs contributed by Catapult are maintained in compliance with GMP Requirements; |
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9.1.2 |
management and governance of the Quality Management System GMP compliance process; |
|
9.1.3 |
GMP regulatory compliance of the Centre, including handling of associated MHRA compliance governance activity such as routine audits inspections, subject to the following provisions: |
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(a) |
From the Occupation Date, and subject to Clause 9.1.3(b) below, if any activity required to ensure GMP regulatory compliance of the Centre, including the handling of associated MHRA compliance governance activity such as inspections (“MHRA Compliance Activity”) impacts any COLLABORATOR Product and/or any COLLABORATOR Manufacturing Process, then the interactions with the MHRA related to such activity will be led by COLLABORATOR with assistance being provided by Catapult. COLLABORATOR will be entitled to nominate representatives to coordinate and accompany all inspections involved in such MHRA Compliance Activity on COLLABORATOR's behalf; |
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(c) |
To the extent any MHRA Compliance Activity impacts on COLLABORATOR’s use of the Module or performance of the COLLABORATOR Manufacturing Process, Catapult will notify COLLABORATOR of such MHRA Compliance Activity and keep COLLABORATOR informed of the progress and communication relevant to such MHRA Compliance Activity. |
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9.1.4 |
insurance as described in Clause 19.1; |
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9.1.5 |
safety systems and equipment such as emergency light testing, fire extinguishers, health and safety equipment outside the Manufacturing Space, and associated safety audits; |
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9.1.6 |
a managed reception within Office Hours, and the provision of a mechanism for COLLABORATOR to access the Module at any time; |
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9.1.7 |
all utilities necessary for the operations of the Centre (but not the Manufacturing Space) as set out in Schedule Error! Reference source not found.; |
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9.1.8 |
support for IT Infrastructure; for the avoidance of doubt, this does not include applications support for COLLABORATOR; |
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9.1.9 |
hosting, maintenance and administration of all IT systems (BMS, EMS, eQMS, LIMS and WMS) plus all required access rights for IT systems required primarily for Centre functions and required even when no Collaborators are in occupation (BMS, EMS); |
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9.1.10 |
receipt of incoming patient material and starting material into the Centre within Office Hours; |
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9.1.11 |
a system for booking in and managing COLLABORATOR owned inventory for raw materials, consumables, product contact materials and excipients within the warehouse; |
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9.1.12 |
short term final product and drug substance storage subject to terms to be agreed; |
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9.1.13 |
out of hours call out system for all facilities alarms (bar the Manufacturing Space alarms); |
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9.1.14 |
cleaning and disinfection of all areas outside of the Manufacturing Space and outside of any Quality Control laboratory space occupied by any Collaborator; |
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9.1.15 |
(save with respect to the Manufacturing Space which is provided for in Clause 9.2.1 and for any Quality Control laboratory space occupied by any Collaborator)) perform environmental monitoring in the form of viable and non-viable particulate monitoring required to demonstrate maintenance of the appropriate environmental classifications; |
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9.1.16 |
access to a controlled rate freezer and allocated short term storage capacity at the following temperatures: controlled room temperature, 2-8°C, -20°C, -80°C and gas phase of liquid nitrogen; |
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9.1.17 |
Toilet provision and services in relation to toilets available for COLLABORATOR use; |
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9.1.18 |
Security input as required for general security of Centre; |
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9.1.19 |
program and relationship management; |
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9.1.20 |
kitchen areas and vending machines for snacks, hot and cold drinks within the Centre; |
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9.1.21 |
a dedicated secure, unfurnished Manufacturing Office and a Non-Manufacturing Office per Module; and |
22
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9.1.22 |
any other Inputs which Catapult, using its reasonable judgment, considers as fundamental to the operation of the Centre and that the COLLABORATOR and all Other Collaborators will draw on in, albeit not necessarily in equal measure. |
|
9.1.23 |
Shift system of warehouse personnel to be available to receive incoming patient material and starting material into the Centre outside of Office Hours, with notice and subject to terms of an Additional Input Agreement if such input is to be utilised by COLLABORATOR; |
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9.2.2 |
measured electrical power to the Manufacturing Space; |
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9.2.3 |
upon request of COLLABORATOR, Manufacturing Space decontamination; |
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9.2.4 |
a measured supply of pharmaceutical grade oxygen, nitrogen, carbon dioxide, and air; |
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9.2.5 |
routine maintenance for the air handling system, including ULPA and HEPA filter changes |
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9.2.6 |
gowning for Catapult staff providing services to the Collaborators, (COLLABORATOR gowning is ordered by COLLABORATOR from Catapult warehouse stock); |
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9.2.7 |
Leased telephone line with a data package from the supplier if required; |
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9.2.8 |
transfer of decontaminated clinical, biological and hazardous chemical liquid waste from the liquid waste staging area and arrange its removal from the Centre by appropriately licensed contractors; |
|
9.2.9 |
transfer of decontaminated clinical and biological solid waste from the solid waste staging area and arrange its removal from the Centre by appropriately licensed contractors; |
|
9.2.10 |
packing, and dispatch as described in Schedule Error! Reference source not found.; |
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9.2.11 |
warehouse movements over and above a fair usage level (to be determined by Catapult from time to time) |
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9.2.12 |
access rights to IT systems required for COLLABORATOR activity within the module: eQMS, LIMS, WMS; |
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9.2.13 |
provision of Quality Assurance inputs to support for COLLABORATOR’s operation within the Module; in terms of handling non-process related deviations, Quality Events and planned changes, cleanroom environmental |
23
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excursions, governance of Catapult generated GMP data provided to COLLABORATOR, providing GMP documentation to support Qualified Person certification of drug product; |
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9.2.14 |
engineering and maintenance support for COLLABORATOR’s operation within the Module. |
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9.3.1 |
Catapult will decontaminate the Manufacturing Space, replace all HEPA filters and re-qualify the Manufacturing Space at termination of the Agreement at COLLABORATOR’s cost; and |
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9.3.2 |
Catapult will select and authorise All Collaborators and ensure their processes and procedures meet the minimum standards required by Catapult, such standard in each case sufficient to meet the requirement of this Agreement including GMP. |
Additional Inputs to be listed once the process is completed in accordance with Clause 9 (iii) above.
The Parties will each nominate two representatives who will form the steering committee for the Project (“Steering Committee”). The Steering Committee will meet (by telephone or in person) as required to discuss matters relating specifically to the COLLABORATOR and/or the Project (such as changes to Contributions and Inputs, staffing updates, Collaboration performance and resolution of issues). The Steering Committee will also participate in dispute resolution as set out in Clause 33 as required.
Catapult undertakes to COLLABORATOR it will ensure that the Collaborator Forums take place in accordance with the frequencies, the parameters, and all other terms set out in Schedule Error! Reference source not found.. Each Collaborator’s input shall have equal weight in such Collaborator Forums and any Collaborator occupying more than one module will exert no greater influence than a Collaborator occupying a single module
Catapult will use commercially reasonable efforts to minimise downtime of the controlled and/or classified areas of the Centre and to plan any such downtime so as to minimise business impact for COLLABORATOR. Catapult will use commercially reasonable efforts to ensure that as much notice as reasonably possible is provided to COLLABORATOR for the annual four-week window in which the annual shutdown of the Centre is planned and implemented each Year and the annual two-week window in which the semi-annual shutdowns of the Centre are planned and implemented each Year, with the date of these shut-downs being confirmed by
24
Catapult with at least 4 months’ notice to COLLABORATOR. The Parties acknowledge that unplanned downtime may occur at the Centre in circumstances where Catapult is not able to provide advance notice, including in emergencies or where critical or urgent issues arise at the Centre.
10.1 |
COLLABORATOR will, and will ensure that COLLABORATOR Personnel will, comply with the following COLLABORATOR Responsibilities: |
|
10.1.1 |
abide by all Applicable Laws plus the Code of Conduct and all other guidelines and protocols in force from time to time at the Centre, including all Catapult SOPs; |
|
10.1.2 |
perform health and safety and quality risk assessments for all materials and processes before such materials and processes enter or are carried out in (as applicable) the Manufacturing Space and provided always that such materials and processes have first been authorised by Catapult and provide copies of such risk assessments to Catapult on request; |
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10.1.3 |
handle all large volume liquid waste (such as culture media and buffers) and decontaminate it in-situ within the cleanroom before securely and safely transferring it to the handling area in the Centre (as designated by Catapult from time to time); |
|
10.1.4 |
collect all small volume liquid waste in a sealable container within the Manufacturing Space and decontaminate it in-situ before removing it from the cleanroom via the MAL out to a waste staging and disposal area; |
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10.1.5 |
remove all solid waste from the cleanroom via the MAL out to a staging area for removal by the Catapult; |
|
10.1.6 |
maintain and implement in accordance with Catapult’s standard operating procedures cleaning regimes for the Manufacturing Space; |
|
10.1.7 |
unless otherwise agreed with Catapult, define and implement Process Transfer; |
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10.1.8 |
perform as required by Catapult all appropriate environmental monitoring within the Manufacturing Space and make the plates available to Catapult for analysis; |
|
10.1.9 |
obtain, and maintain insurance in accordance with Clause 19; and |
|
10.1.10 |
comply with its obligations under the QTA. |
10.3 |
If COLLABORATOR delays or does not perform its responsibilities under this Agreement, Catapult may perform such responsibilities in its place directly or in |
25
collaboration with a third party and COLLABORATOR will compensate Catapult for any costs it incurs in discharging such responsibilities on COLLABORATOR’s behalf. |
26
any protection for the Foreground Intellectual Property, including filing and prosecuting patent applications. Catapult will ensure that its employees involved in the creation of the Foreground Intellectual Property give COLLABORATOR such assistance as COLLABORATOR may reasonably request in connection with the registration and protection of the Foreground Intellectual Property, including filing and prosecuting patent applications, and taking any action in respect of any alleged or actual infringement of the Foreground Intellectual Property (for clarity, any costs connected with such assistance will be borne by COLLABORATOR). |
Subject to COLLABORATOR meeting the conditions under Clause 11.3, from the Termination Date, such licence will extend to permit COLLABORATOR to replicate the Module, or in the alternative, to such extent as required to enable COLLABORATOR to otherwise replicate the COLLABORATOR Manufacturing Process, or to produce the COLLABORATOR Product.
Any costs associated with the license of any Intellectual Property to COLLABORATOR under this Clause 12.2 will be borne by COLLABORATOR.
12.3 |
To the extent that any Catapult Foreground Intellectual Property is capable of prospective assignment, COLLABORATOR now assigns the Catapult Foreground Intellectual Property to Catapult; and to the extent any Catapult Foreground Intellectual Property cannot prospectively be assigned, COLLABORATOR will assign such Catapult Foreground Intellectual Property to Catapult as and when they are created, at the request of Catapult. |
12.5 |
In the event any COLLABORATOR Foreground Intellectual Property is required by any Other Collaborator or Catapult in order to operate within the Centre in |
27
accordance with GMP and the QTA, COLLABORATOR will grant a non-exclusive, sub-licensable, royalty free and perpetual licence to such Other Collaborators and Catapult of such COLLABORATOR Foreground Intellectual Property to operate within the Centre. |
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13.1.1 |
to maintain as secret and confidential all Confidential Information of the Disclosing Party and its Affiliates; |
|
13.1.2 |
where the Receiving Party is Catapult, to use such Confidential Information only for the purposes of making the Centre, Module and Inputs available to COLLABORATOR (and Other Collaborators, solely with respect to their Confidential Information) in accordance with this Agreement and the QTA and for exercising its rights under this Agreement and the QTA, or where the Receiving Party is COLLABORATOR, for the purpose of exercising its rights, and complying with its obligations, under this Agreement and the QTA (in each case, a “Permitted Purpose”, and together, the “Permitted Purposes” as it applies to each Party); and |
|
13.1.3 |
Subject to Clause 13.4, to disclose such Confidential Information only to those of its employees, officers, contractors, consultants, advisors, legal counsel, Affiliates and sub-licensees (collectively “Representatives”) pursuant to this Agreement (if any) to whom and to the extent that such disclosure is reasonably necessary for the Permitted Purposes provided that such Representatives are bound by obligations of confidentiality no less onerous than those in this Agreement. For clarity, notwithstanding the foregoing, Catapult shall not disclose COLLABORATOR’s or its Affiliates’ Confidential Information (or the Confidential Information of any other entity with which COLLABORATOR or any of its Affiliates is in business negotiations or has contracted or to which it owes a duty of confidence) to any Other Collaborator, without (i) COLLABORATOR’s express prior written permission, on a case by case basis, and (ii) Catapult complying with Clause 13.6 and ensuring that such Collaborator is made aware of the confidential nature of the Confidential Information. |
13.2 |
The provisions of Clause 13.1 shall not apply to Confidential Information which the Receiving Party can demonstrate by reasonable, written evidence: |
|
13.2.1 |
was, prior to its receipt by the Receiving Party from the Disclosing Party or Alternative Disclosing Party, in the possession of the Receiving Party and at its free disposal; |
|
13.2.2 |
is subsequently disclosed to the Receiving Party without any obligations of confidence by a Third Party who has not derived it directly or indirectly from the Disclosing Party or Alternative Disclosing Party; |
|
13.2.3 |
is or becomes generally available to the public through no act or default of the Receiving Party or its agents, officers, employees, Affiliates, advisors, contractors, consultants, legal counsel or sub-licensees; |
|
13.2.4 |
is independently developed by the Receiving Party by individuals who have not had any direct or indirect access to the Disclosing Party’s or Alternative Disclosing Party’s Confidential Information. |
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|
13.5 |
Upon any termination or expiry of this Agreement, the Receiving Party shall return to the Disclosing Party or Alternative Disclosing Party any documents or other materials that contain the Disclosing Party’s or Alternative Disclosing Party’s Confidential Information, including all copies made, and make no further use or disclosure thereof save that the Receiving Party shall not be obliged to purge or delete Confidential Information of the Disclosing Party or Alternative Disclosing Party from its IT systems that is stored by any automated back-up system, and shall be permitted to retain one (1) copy of all such Confidential information in its legal files solely for purposes of ensuring compliance with the terms of this Agreement, and shall not otherwise use or disclose such Confidential Information. |
13.6 |
For the avoidance of doubt, and in light of Catapult’s objective to disseminate best practices and xxxxxx the development of the regenerative medicine sector in the UK, Catapult shall be entitled to publish or otherwise disclose any of its Confidential Information (but excluding the terms of this Agreement), including the Catapult Background Intellectual Property and Catapult Foreground Intellectual Property. |
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13.9 |
Without prejudice, and in addition, to COLLABORATOR’s obligation under Clause 13.3, if COLLABORATOR is required to or intends to mention Catapult in any financial disclosures required by any financial authority, COLLABORATOR shall first provide Catapult with a reasonable opportunity to review and comment on any such proposed disclosure. |
Each Party warrants, represents and undertakes to the other that:
|
14.1.1 |
it has full capacity and authority to enter into and to perform this Agreement; |
|
14.1.2 |
there are no: |
|
(a) |
actions, suits or proceedings pending or, to its knowledge, threatened against or affecting it before any court or administrative body or arbitration tribunal; or |
|
(b) |
investigations by any Regulatory Authority pending or, to its knowledge, threatened against or affecting it; |
|
14.1.3 |
once duly executed, this Agreement will constitute its legal, valid and binding obligations; and |
|
14.1.4 |
it is not aware of any matters which might adversely affect its ability to perform its obligations pursuant to this Agreement. |
14.2 |
Catapult Warranties |
Catapult warrants, represents and undertakes to COLLABORATOR that from the Effective Date until the Termination Date:
|
14.2.1 |
it will use reasonable commercial endeavours to ensure it will at all times have the ability and all rights, titles and Necessary Consents to perform its obligations under this Agreement; |
|
14.2.2 |
comply with its obligations under the QTA; |
|
14.2.3 |
it will maintain the Lease and perform all of its obligations thereunder; |
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14.2.4 |
it will provide the Inputs with all reasonable care and skill and in any event in accordance with Applicable Law; and |
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14.2.5 |
it will make available the Centre and the Module in accordance with the provisions of this Agreement and in any event in accordance with all Applicable Law. |
30
|
14.3 |
COLLABORATOR Warranties |
COLLABORATOR warrants, represents and undertakes to Catapult that from the Effective Date until the Termination Date it will:
|
14.3.1 |
use reasonable commercial endeavours to ensure it will at all times have the ability and all rights, titles and Necessary Consents to perform its obligations under this Agreement; |
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14.3.2 |
perform both its obligations under this Agreement and all activities in respect of the Project in accordance with all Applicable Law and the Code of Conduct; and |
|
14.3.3 |
perform COLLABORATOR’s Responsibilities. |
Each Party represents, warrants, and undertakes to the other Party that:
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14.4.1 |
to its knowledge and belief, it has all right, title, and interest in and to its Background Intellectual Property (subject to the Third Party’s Intellectual Property in Catapult’s Background Intellectual Property as described in Clause 11.3); and |
14.5 |
Except as expressly provided in Clauses 11.3 and 14.4, neither Party makes any representation nor gives any warranty or undertaking: |
|
14.5.1 |
as to the efficacy or usefulness of its Background Intellectual Property; |
|
14.5.2 |
that the use of any of its Background Intellectual Property or the exercise of any of the rights granted under this Agreement will not infringe any other Intellectual Property or other rights of any other person; |
|
14.5.3 |
that the use of any of its Background Intellectual Property under or in connection with this Agreement will produce products of satisfactory or merchantable quality or fit for their intended purpose or that any product will not have any latent or other defects, whether or not discoverable; or |
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14.5.4 |
as imposing any obligation on it to bring or prosecute actions or proceedings against third parties for infringement. |
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|
15.1.1 |
any claim or proceedings made, brought or threatened against Catapult and/or its Affiliates by a Third Party (a) in respect of a COLLABORATOR Product or COLLABORATOR Manufacturing Process, or (b) because of the negligence, omission or wilful misconduct of COLLABORATOR, its Affiliates, employees, agents, visitors or contractors; |
|
15.1.3 |
any recommendation, investigation, action or proceeding by a Regulatory Authority which arises as a result of COLLABORATOR’s breach of this Agreement and/or the QTA. Any assessment of costs or losses under a claim under this Clause 15.1.3 shall solely be in respect of the proportion of losses which flow directly from COLLABORATOR and shall exclude any contributory act or omission of any Third Party which is not an agent, visitor or subcontractor of COLLABORATOR. |
15.2 |
Indemnification of Catapult and its Affiliates under Clause 15.1 is conditional upon Catapult and its Affiliates (as applicable) discharging the following obligations. If any Third Party makes a claim, or notifies an intention to make a claim, against Catapult and/or its Affiliates which may reasonably be considered likely to give rise to a liability under this indemnity (“Catapult Claim”), Catapult shall : (a) promptly, on becoming aware of such Catapult Claim, notify COLLABORATOR of the existence of the relevant Catapult Claim; (b) refrain (and ensure its Affiliates refrain) from making any admission of liability, agreement or compromise in respect of the relevant Catapult Claim, without the prior written consent of COLLABORATOR (such consent not to be unreasonably withheld, delayed or conditioned); and (c) give COLLABORATOR (and ensure its Affiliates (as applicable) give COLLABORATOR) sole control over the defence and/or settlement of the relevant Catapult Claim, but excluding any recommendation, investigation, action or proceeding by a Regulatory Authority, which Catapult shall control (provided that Catapult (and any Affiliate of Catapult) shall not enter into any financial settlement without the prior written consent of COLLABORATOR, such consent not to be unreasonably withheld, conditioned or delayed). |
15.3 |
Indemnification of Catapult and its Affiliates under Clause 15.1 shall not apply to the extent that the indemnified Catapult Loss is caused by or results from the negligence, omission or wilful misconduct of Catapult, its Affiliates, employees, agents or subcontractors, or their failure to take any measures as are reasonable in the relevant circumstances to mitigate the Catapult Loss. |
32
|
15.4.1 |
any claim or proceedings made, brought or threatened against COLLABORATOR and/or its Affiliates by a Third Party (a) in respect of any of Catapult’s property within the Centre’s demise, or (b) because of the negligence, omission or wilful misconduct of Catapult, its Affiliates, employees, agents, visitors or subcontractors; |
|
15.4.2 |
any claim or proceedings made, brought or threatened against COLLABORATOR and/or its Affiliates by a Third Party arising from any loss of or damage to the tangible property or equipment belonging to a Third Party caused by or resulting from the negligence, omission or wilful misconduct of Catapult, its Affiliates, visitors, employees, agents or subcontractors; and |
|
15.4.3 |
any recommendation, investigation, action or proceeding by a Regulatory Authority which arises as a result of Catapult’s breach of this Agreement and/or the QTA. |
15.5 |
Indemnification of COLLABORATOR and its Affiliates under Clause 15.4 is conditional upon COLLABORATOR and its Affiliates (as applicable) discharging the following obligations. If any Third Party makes a claim, or notifies an intention to make a claim, against COLLABORATOR and/or its Affiliates which may reasonably be considered likely to give rise to a liability under this indemnity (“COLLABORATOR Claim”), COLLABORATOR shall: (a) promptly, on becoming aware of such COLLABORATOR Claim, notify Catapult of the existence of the relevant COLLABORATOR Claim; (b) refrain (and ensure its Affiliates refrain) from making any admissions of liability, agreement or compromise in respect of the relevant COLLABORATOR Claim, without the prior written consent of Catapult (such consent not to be unreasonably withheld, delayed or conditioned); and (c) give Catapult (and ensure its Affiliates (as applicable) give Catapult) sole control over the defence and/or settlement of the relevant COLLABORATOR Claim, but excluding any recommendation, investigation, action or proceeding by a Regulatory Authority which relates solely to a COLLABORATOR Manufacturing Process and not the Module, Centre, Catapult’s business systems or Catapult’s QMS, which investigation, action or proceeding COLLABORATOR shall control (provided that COLLABORATOR (and any Affiliate of COLLABORATOR) shall not enter into any financial settlement without the prior written consent of Catapult, such consent not to be unreasonably withheld, conditioned or delayed). |
15.6 |
Indemnification of COLLABORATOR and its Affiliates under Clause 15.4 shall not apply to the extent that the indemnified COLLABORATOR Loss is caused by or results from the negligence, omission or wilful misconduct of COLLABORATOR, its Affiliates employees, agents or contractors, or their failure to take any measures as are reasonable in the relevant circumstances to mitigate the COLLABORATOR Loss. |
33
|
16.1.1 |
In light of this, Catapult will procure from each Collaborator, prior to their occupation of the Centre, contractual agreement not to commence or sustain legal proceedings against COLLABORATOR (or any Other Collaborators or Catapult) for damages, or any other financial reimbursement (“Agreement Not to Xxx”), as a consequence of any unexpected and unintended consequences as a result of such a situation at the Centre as described in this Clause 16.1 (“Unforeseen Risks”) unless it is a result of attributable negligence or wilful misconduct of COLLABORATOR (or any Other Collaborators or Catapult, as applicable), breach of confidence, material breach of any obligation under the relevant Other Collaborator’s (or, COLLABORATOR’S, or Catapult's) collaboration agreement or quality agreement for the Centre, or material breach of Catapult SOPs or breach of Applicable Laws, by COLLABORATOR (or any Other Collaborators or Catapult, as applicable) and shall procure a direct right of enforcement of such Agreement Not to Xxx by COLLABORATOR against each such Other Collaborator or Catapult pursuant to the Contracts (Rights of Third Parties) Xxx 0000. |
|
16.1.2 |
With respect to each Other Collaborator that Catapult has obtained an enforceable Agreement Not to Xxx in accordance with Clause 16.1.1, which COLLABORATOR has a direct right to enforce against such Other Collaborator pursuant to the Contracts (Rights of Third Parties) Xxx 0000, COLLABORATOR agrees that it shall not commence or sustain legal proceedings against such a Other Collaborator for damages, or any other financial reimbursement, as a consequence of any Unforeseen Risks unless it is a result of attributable negligence or wilful misconduct of, or a breach of confidence, material breach of any obligation under the relevant Other Collaborator’s collaboration agreement or quality agreement for the Centre, or material breach of Catapult SOPs or breach of Applicable Laws by, such a Other Collaborator. |
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16.1.3 |
Catapult and COLLABORATOR, each agree not to commence or sustain legal proceedings against the other Party for damages, or any other financial reimbursement, as a consequence of any Unforeseen Risks unless it is a result of attributable negligence or wilful misconduct of the other Party, or is a breach of confidence, material breach of any obligation under this Agreement or the QTA, or a material breach of Catapult SOPs or breach of Applicable Laws, by the other Party. |
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16.1.4 |
This Clause 16.1 is not intended to qualify, and is subject to and without prejudice to, each Party’s rights and obligations under Clause Error! Reference source not found. (Indemnity). |
16.2 |
Each Party is obliged to abide by the operating requirements of the Centre in order to comply with GMP (as defined in the Quality Technical Agreement) and exercise an appropriate duty of care such as to minimise the frequency and severity of events alluded to in Clause 16.1, thus offering each other mutual protection. In order to ensure no Party exposes themselves to unreasonable financial risk as a result of such a situation, Catapult and COLLABORATOR (and Catapult will procure this of each Other Collaborator in occupation of the Centre) will ensure the continued and uninterrupted maintenance of an appropriate level of public liability, business continuity and professional indemnity insurances. |
16.3 |
Without prejudice to Clauses 15.1, 16.1, 16.5, 16.6 and 16.7 , the maximum aggregate Liability of COLLABORATOR which arises from any single event which |
34
occurs in any Year will be limited to [***] for any single event, with no limit on the number of claims made against it from Catapult. |
16.7 |
Without prejudice to Clause 16.6, nothing in this Agreement will operate to exclude or restrict COLLABORATOR’s Liability: |
|
16.7.1 |
under the indemnity contained in Clause 15.1; or |
|
16.7.2 |
to pay the Contributions that are correctly incurred under this Agreement; or |
|
16.7.3 |
to pay the Catapult Compensations. |
16.8 |
The Parties agree that they have negotiated this Clause 16 and the allocation of risk in this Clause is a fair and equitable position. |
17.2 |
On the conditions that (a) COLLABORATOR has consistently complied with its obligations in the Collaboration Agreement throughout the Term up to the date the Option is exercised, and (b) the Option is exercised not less than 12 months before the end of the Term, then COLLABORATOR will have a six-month period from the start of the 12 month notice period during which it will be entitled to negotiate with Catapult (both acting reasonably) the duration, terms and conditions of an extension to the Collaboration including its occupation of the Module (the “Option”). Such extension will be on substantially the same terms as the existing Agreement at the rates prevailing at the time of extension (although in the event there are factors that are out of Catapult’s control or there are unavoidable requirements that mean significant changes are required as to how the Centre is operated following the end of the Term, such “substantially” same terms may not be possible). At the end of such 6 month period the Option will lapse and Catapult will have no obligation to continue such negotiations with COLLABORATOR. |
35
17.3 |
The Parties may terminate this Agreement at any time by mutual written consent, signed by the authorised signatories of the Parties. |
17.4 |
Either Party may elect to terminate this Agreement at any time by notice in writing to the other Party, such notice to take effect as specified in the notice: |
17.6 |
A Party’s right of termination under this Agreement, and the exercise of any such right, will be without prejudice to any other right or remedy (including any right to claim damages) that such Party may have in the event of a breach of contract or other default by the other Party. |
|
18.1.2 |
effective on or after the Term Start Date, COLLABORATOR will pay to Catapult [***] |
18.1.2.1[***]
18.1.2.2[***]
36
save that where the circumstances set out in clause 18.1.2 apply, and where the Catapult successfully enters into a collaboration agreement with a replacement collaborator to occupy the Module then or previously assigned to the COLLABORATOR (“Replacement Collaborator”), the COLLABORATOR shall be entitled to a partial refund of the Catapult Compensations (defined below) in an amount equal to [***] to the date the Term was due to expire, but for such early termination by the COLLABORATOR. Such partial refund shall be due and payable by Catapult in monthly instalments, subject to Catapult having received the relevant payment from the Replacement Collaborator. Notwithstanding the foregoing and for the avoidance of doubt, the Catapult shall be under no obligation, when engaging a Replacement Collaborator to offer them the Module then or previously occupied by the COLLABORATOR or to give any preferential treatment to such Module.
The contributions payable by COLLABORATOR pursuant to Clauses 18.2.1 and 18.2.2, as applicable, shall be the “Catapult Compensations” and shall become immediately due and payable in full by COLLABORATOR on COLLABORATOR’s service of notice of termination on Catapult pursuant to Clause 17.5. COLLABORATOR’s payments to Catapult under this Clause 18.1 shall be made in accordance with Clause 8.3.5. For the purposes of the calculations of the Catapult Compensations under Clauses 18.2.1 and 18.2.2 the applicable annual Facility Contribution, Business Rates Contributions and Integral Input Contributions will be the annual Facility Contribution, Business Rates Contributions and Integral Input Contributions applicable during the Year in which COLLABORATOR serves notice pursuant to Clause 17.5.
18.2 |
Upon termination of this Agreement for any reason (and unless otherwise agreed by the Parties in a subsequent, written agreement, including any agreement entered into in accordance with the provisions of Clause 26.1): |
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COLLABORATOR personnel personal effects within the Module or in the Centre generally. Such insurances may be limited in respect of one claim provided that such limit must be at least [***]. COLLABORATOR will continue to maintain product liability insurance for a further [***] from the end of the Term. COLLABORATOR acknowledges that Catapult will have no responsibility for any COLLABORATOR owned equipment or any COLLABORATOR Personnel personal effects located in the Module or any other part of the Centre. |
19.3 |
If there is destruction or damage to the Centre that leaves the whole or substantially the whole of the Centre and / or the Module unfit for occupation and use or inaccessible, the Catapult may terminate this Agreement immediately by written notice to COLLABORATOR at any time within the period of two (2) years after the date of such damage or destruction. |
19.4 |
If there is destruction or damage to the Centre that leaves the whole or substantially the whole of the Centre and / or the Module unfit for occupation and use or inaccessible and the Module has not been made fit for occupation and use by COLLABORATOR within 2 years of the date of such destruction or damage then either Party may serve notice on the other to terminate this Agreement with immediate effect, but before such reinstatement is completed. |
19.5 |
If there is destruction or damage to the Centre by any of the Insured Risks that leaves the whole or substantially the whole of the Centre and / or the Module unfit for occupation and use or inaccessible, then, save to the extent that the Catapult’s insurance has not been vitiated or policy moneys refused because of any act or default of COLLABORATOR, its Affiliates, employees, agents, visitors or contractors, then the Facility Charge, the Activity Related Input Contributions, the Integral Input Contributions, and the Business Rates Contribution or a fair proportion of them will not be payable from and including the date of such damage or destruction until the earlier of the date that the Module is once again fit for occupation and use and accessible and the date two (2) years from and including the date of such damage or destruction. |
20.1 |
Each Party agrees that, in connection with this Agreement and the Project, they will each, (and will procure that their respective officers, employees, agents and any other persons who perform services for them or on their behalf in connection with this Agreement will): |
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20.1.1 |
not commit any act or omission which causes or could cause the other Party to breach, or commit an offence under, any laws relating to anti-bribery and/or anti-corruption; |
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20.1.2 |
keep accurate and up to date records showing all payments made and received and all other advantages given and received in connection with this Agreement and the steps taken to comply with this Clause 20, and permit the other Party to inspect those records as reasonably required; |
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20.1.3 |
promptly notify the other Party of: |
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(a) |
any request or demand for any financial or other advantage received by it (or that person); and |
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|
(b) |
any financial or other advantage it (or that person) give or intend to give |
whether directly or indirectly in connection with this Agreement; and
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20.1.4 |
promptly notify the other Party of any breach of this Clause 20. |
The Parties agree consent is required before use of the other’s name, or any adaptation of their name, or any of their logo(s), trademark(s), or other of their device(s) in any advertising, promotional, or sales materials (however, they also agree that such consent is not to be unreasonably withheld).
22. |
STATE AID |
Catapult will be entitled to cooperate fully with any investigation by any grant funder of Catapult or by the European Commission or any court of law with respect to this Agreement regarding the grant/alleged grant of state aid and the provision of Inputs hereunder and COLLABORATOR will, if so requested by Catapult, promptly provide to Catapult all reasonable and necessary assistance in connection with any such investigation(s);
Catapult will keep COLLABORATOR informed of any active and specific investigation into this Agreement and, where possible, liaise with COLLABORATOR concerning any response to the European Commission; and
the Parties will comply with any ruling of the European Commission or court of law in relation to the application of the EU state aid rules to this Agreement.
22.2 |
The obligations set out in Clause 22.1 above will subsist for a period of ten (10) years from the Effective Date, notwithstanding any earlier termination or expiry of this Agreement. |
23. |
NOTICES |
23.1 |
Any notice required to be given under this Agreement will be given in writing and sent by prepaid post or courier, delivered personal, or sent by email to the following addresses or such other address as may be notified by the relevant Party from time to time in writing: |
To Catapult: |
To COLLABORATOR:
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If sent by post to:
Cell Therapy Catapult 12th Floor Tower Wing Guy’s Hospital Great Xxxx Xxxx Xxxxxx XX0 0XX Xxxxxx Xxxxxxx |
If sent by post to:
Stevenage Bioscience Catalyst Xxxxxxx Xxxx Xxxx Xxxxxxxxx Xxxxx XX0 0XX Xxxxxx Xxxxxxx
|
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For the attention of:
[***]
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For the attention of:
[***]
With a copy to: [***] |
If sent by email, to:
[***]
|
If sent by email, to:
[***]
With a copy to: [***]
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23.2 |
Any notice so sent will be deemed to have been duly given: |
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23.2.1 |
if sent by personal delivery or courier, on delivery at the address of the relevant Party; |
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23.2.2 |
if sent by prepaid post, five days after the date of posting; and |
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23.2.3 |
if sent by email, only on acknowledgement of receipt, such acknowledgement not being an automated message. |
24. |
FURTHER ASSURANCES |
Each Party will, as and when requested by the other Party and without charge, do all such acts and execute all such documents as may be reasonably necessary to give full effect to the provisions of this Agreement.
25. |
ENTIRE AGREEMENT |
25.1 |
This Agreement constitutes the entire agreement between the Parties and supersedes and replaces any and all previous agreements, understandings or arrangements between the Parties, whether oral or in writing, relating to its subject matter, including the Pre-Existing CDA. |
25.2 |
The Parties acknowledge that in entering into this Agreement they do not rely on any statement, representation (including, without limitation, any negligent misrepresentation but excluding any fraudulent misrepresentation), warranty, course of dealing, custom, understanding or promise except for those expressly set out in this Agreement. |
25.3 |
Except as expressly set forth in this Agreement, neither party grants to the other by implication, estoppel or otherwise, any right, title, licence or interest in any Intellectual Property. |
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26. |
VARIATION |
26.1 |
Subject to Clause 26.2, no variation or amendment to this Agreement will be effective unless it is made in writing and signed by the duly authorised representatives of both Parties. |
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26.2.2 |
If the proposed change has a material impact on the COLLABORATOR Product(s) or COLLABORATOR Manufacturing Process(es), such change will require the mutual written consent of the Parties in the form of an amendment to this Agreement signed by duly authorised representatives of both Parties. |
27. |
ASSIGNMENT AND SUB-CONTRACTING |
27.1 |
Subject to Clause 27.2 and except as provided in Clause 27.3, neither Party will assign, sub-contract, mortgage, charge, or otherwise transfer any rights or obligations under this Agreement, without the prior written consent of the other Party. |
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28. |
WAIVER |
No failure or delay by a Party to exercise any right or remedy provided under this Agreement or by law will constitute a waiver of that or any other right or remedy, nor will any single or partial exercise of any right or remedy preclude the further exercise of such right or remedy.
29. |
SEVERABILITY |
If any provision (or part of any provision) of this Agreement is held to be invalid, void or otherwise unenforceable by a court of competent jurisdiction from whose decision no appeal is available, or from whose decision no appeal is made within the applicable time limit, then the provision (or relevant part of the provision) will be omitted and the remaining provisions of this Agreement (and parts of the relevant provision, as applicable) will continue in full force and effect.
Nothing in this Agreement is intended to, or will be deemed to, establish or imply any agency, partnership or joint venture between the Parties. Neither Party will act or describe itself as the agent of the other Party and neither Party will have, or hold itself out as having any authority to make commitments for or on behalf of the other Party.
31. |
THIRD PARTY RIGHTS |
This Agreement does not create any right enforceable by any person who is not a Party to it save for (i) with respect to Clause 13 which the Parties agree may be directly enforceable (as applicable, as an Alternative Disclosing Party) by any Other Collaborator that has occupied the Centre concurrently with COLLABORATOR, provided that COLLABORATOR is able to directly enforce provisions equivalent to Clause 13 with respect to COLLABORATOR’s Confidential Information in a collaboration agreement between such Other Collaborator and Catapult, and (ii) as provided in Clause 16.1.
32.1 |
This Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) will be governed by and construed in accordance with the laws of England and Wales. |
32.2 |
The parties to this Agreement irrevocably agree that the courts of England will have exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with this Agreement or its subject matter or formation (including non-contractual disputes or claims), except that a Party may seek an interim injunction in any court of competent jurisdiction. |
33.1 |
If a dispute arises out of or in connection with this Agreement or the performance, validity or enforceability of it (Dispute), then, except as expressly provided in specific clauses of this Agreement, the Parties will follow the procedure set out in this clause: |
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33.1.1 |
either Party will give to the other written notice of the Dispute, setting out its nature and full particulars (Dispute Notice), together with relevant supporting |
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|
documents. On service of the Dispute Notice, the Chief Business Officer, or another authorised representative, of the Catapult, and the head of manufacturing of COLLABORATOR or another authorised representative of COLLABORATOR will attempt in good faith to resolve the Dispute; |
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33.1.2 |
if the Catapult representative and the COLLABORATOR representative are for any reason unable to resolve the Dispute within 30 days of service of the Dispute Notice, the Parties agree to enter into mediation in good faith to settle the Dispute in accordance with the Centre for Effective Dispute Resolution (CEDR) Model Mediation Procedure. To initiate the mediation, a Party must serve notice in writing (ADR notice) to the other Party to the Dispute, referring the dispute to mediation. A copy of the ADR notice should be sent to CEDR. Unless otherwise agreed between the Parties within 10 days of service of the ADR Notice, the mediator will be nominated by CEDR. Unless otherwise agreed between the Parties, the mediation will start not later than 15 days after the date of service of the ADR notice on the other Party. |
33.2 |
No Party may commence any court proceedings under Clause 32 (Governing Law and Jurisdiction) in relation to the whole or part of the Dispute until 40 days after service of the ADR notice, provided that the right to issue proceedings is not prejudiced by a delay. |
33.3 |
If the Dispute is not resolved within 40 days after service of the ADR notice on the other Party, or either Party fails to participate or ceases to participate in the mediation before the expiry of that 40-day period, or the mediation terminates before the expiry of that 40-day period, the Dispute will be finally resolved by the courts of England and Wales in accordance with Clause 32 (Governing Law and Jurisdiction) in this Agreement. |
This Agreement may be executed in any number of counterparts, each of which when executed and delivered will constitute a duplicate original of this Agreement, but all the counterparts will together constitute the same agreement. If this Agreement is executed in counterparts, it will not be effective unless and until each party has executed and delivered a counterpart to the other party. Transmission of an executed counterpart of this Agreement by (a) fax or (b) email (including in PDF or JPEG format) shall take effect as delivery of an executed counterpart of this Agreement. Each Party may sign this Agreement by electronic signature (whatever form the electronic signature takes) and the Parties agree that this method of signature is as conclusive of our intention to be bound by this Agreement as if signed by each Party's manuscript signature.
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35.3 |
The Affected Party will promptly notify the other Party in writing when a Force Majeure Event causes a failure or delay in performance and when its ceases to do so. Should the Force Majeure Event continue for a period of more than 90 continuous days, the Affected party may terminate the agreement by providing 30 days written notice to terminate this Agreement that may be adversely impacted by the Force Majeure Event and the Parties shall comply with Clause 8.3.5. |
36.1 |
“Data Protection Legislation” means the EU General Data Protection Regulation (2016/679) and all other applicable legislation relating to privacy or data protection in the United Kingdom. |
36.2 |
In this Agreement the terms: |
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36.2.1 |
“Personal Data”, “Data Subject” and “Process” are as defined in the EU General Data Protection Regulation (2016/679) (“Act”). Each Party shall comply with its respective obligations under the provisions of the Act and all applicable Data Protection Legislation; |
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36.2.2 |
“Data Processor” and “Data Controller” are as “Data Processor” and “Data Controller” are defined in the Act. |
36.3 |
COLLABORATOR shall act as the Data Controller in respect of any Personal Data Processed by Catapult on behalf of COLLABORATOR in connection with this Agreement, the Project and/or Inputs and in compliance with COLLABORATOR’s obligations as such under the Act. Nothing in this Clause 36 relieves Catapult of its own obligations as Data Processor under the Data Protection Legislation; some of the material Processing it will perform, including examples of the Personal Data and categories of data subject connected to this Processing, is broadly (but not exhaustively) set out in the Catapult Data Processing Summary in Schedule Error! Reference source not found. to the rear of this Agreement. |
36.4 |
Insofar as COLLABORATOR provides or otherwise makes available Personal Data to Catapult and such Personal Data is Processed by Catapult, or if Catapult is required to Process Personal Data on behalf of COLLABORATOR in connection with this Agreement, the Project and/or Inputs, COLLABORATOR shall ensure that it has all rights, consents and authority to permit Catapult to lawfully Process such Personal Data and will comply with applicable Data Protection Legislation generally including ensuring that all Personal Data provided or otherwise made available pursuant to this Agreement to Catapult is: |
(a) adequate, relevant and limited to what is necessary for Catapult to discharge its obligations, and to enjoy its rights under this Agreement; and
(b) accurate and, where necessary, kept up to date.
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36.5 |
In so far as Catapult Processes any Personal Data on behalf of COLLABORATOR, Catapult shall: |
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36.5.2 |
not otherwise modify, amend or alter the contents of the Personal Data or disclose or permit the disclosure of any of the Personal Data to any third party unless: (i) specifically authorised in writing by COLLABORATOR or (ii) required in order for Catapult to perform its obligations under this Agreement or enjoy its rights under this Agreement (including where such obligations are sub-contracted to a third party); |
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36.5.3 |
implement appropriate technical and organisational methods to maintain the security of such Personal Data and preventing unauthorised or unlawful Processing and against accidental loss, destruction, damage, alteration or disclosure; |
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36.5.4 |
keep and procure that all of its employees, contractors and agents keep, the Personal Data confidential in accordance with Catapult's confidentiality obligations under Clause 13; |
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36.5.5 |
maintain a record of its Processing activities and, at COLLABORATOR’s cost in respect of Catapult's out of pocket expenses, provide all information to COLLABORATOR as is reasonably necessary for COLLABORATOR to demonstrate compliance with its obligations pursuant to Article 28 of the Act, or any provisions under equivalent legislation that is implemented in the UK after the date of this Agreement. |
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36.5.6 |
permit audits, including inspections, conducted by or on behalf of COLLABORATOR or its regulators including permitting audits to the extent that these are demanded by a Regulatory Authority overseeing compliance with the Act. To the extent the following do not contravene the conditions imposed by a Regulatory Authority COLLABORATOR will: not conduct more than one audit per calendar year, give Catapult reasonable (and at least 14 days’) prior written notice of each such audit and ensure that each audit is carried out during Catapult’s normal business hours, so as to cause the minimum disruption to Catapult’s business and without COLLABORATOR or its auditor having any access to any data belonging to a person other than COLLABORATOR; |
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36.5.7 |
notify COLLABORATOR in writing without undue delay and in any event within 48 hours of discovery of, and provide reasonable cooperation (at COLLABORATOR’s cost, except where the breach is caused by Catapult or its agents or subcontractors in which case such cooperation will be provided at Catapult’s cost) in the event of, any breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, Personal Data in Catapult's possession or control; |
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36.5.8 |
notify COLLABORATOR in writing without undue delay and in any event within ten days of receipt if it receives a request from a Data Subject to have |
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|
access to that person's Personal Data, a complaint or request relating to COLLABORATOR 's obligations under Data Protection Legislation or any other communication relating to the Processing of Personal Data, in each case where such request, complaint or communication relates directly to the Processing of Personal Data undertaken by Catapult on behalf of COLLABORATOR under or in connection with this Agreement; and |
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36.5.9 |
insofar as is possible, assist COLLABORATOR (at COLLABORATOR’s cost, except where the complaint or request arises from Catapult’s, or its agents or subcontractors processing of that Personal Data other than in accordance with Clause 36, in which case such assistance will be provided at Catapult’s cost) in relation to any complaint or request made by a regulator or Data Subject in respect of any Personal Data Processed by Catapult on behalf of COLLABORATOR under or in connection with this Agreement. |
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36.5.10 |
at the choice of COLLABORATOR, delete or return all Personal Data to COLLABORATOR promptly after termination or expiry of this Agreement, and delete all copies of such Personal Data (save to the extent that retention of copies is required by Applicable Law or that electronic copies are made on the Catapult IT systems as part of regular business archiving activity, but Catapult will ensure that any such archived electronic copies are kept confidential and in compliance with this Clause 36) providing confirmation of such deletion to COLLABORATOR; |
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36.6.1 |
provide an adequate level of protection to any Personal Data that is transferred outside of the EEA (which may include ensuring that the entity located outside the EEA to which Personal Data is transferred enters into the standard contractual clauses for the transfer of Personal Data from the EU to processors in third countries); and |
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36.6.2 |
comply with any other reasonable instructions notified to it by COLLABORATOR, |
36.7 |
COLLABORATOR authorises Catapult to engage other Data Processors and sub-processors in respect of any Personal Data Processing that is undertaken in connection with this Agreement and in accordance with its terms. Where Catapult duly engages a sub-processor to carry out specific Processing activities on behalf of COLLABORATOR, Catapult shall ensure that it enters into a written contract with such sub-processor containing data protection obligations no less onerous than those set out in this Clause 36 which shall apply to the sub-processor. Catapult shall remain liable for the acts and omission of any such sub-processor. |
36.8 |
Catapult shall without undue delay (and in any event within 48 hours of it becoming aware) notify COLLABORATOR in the event that it becomes aware of any breach of the Data Protection Legislation by Catapult or any of the subcontractors of Catapult in connection with this Agreement. |
36.9 |
Subject to Clause 16.6, COLLABORATOR agrees that Catapult shall have no liability (whether in contract, tort, misrepresentation, restitution, under statute or otherwise, including under any indemnities, in each case howsoever caused including if caused |
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by negligence) to COLLABORATOR in connection with any act and/or omission by Catapult to the extent that the liability arises from: |
(a) any breach of the Data Protection Legislation by COLLABORATOR; or
(b) any breach by COLLABORATOR of its obligations under this Clause 36; or
(c) Catapult complying with any written instructions from COLLABORATOR in accordance with Clause 36.5.1.
36.10 |
Subject to Clause 16.6, Catapult agrees that COLLABORATOR shall have no liability (whether in contract, tort, misrepresentation, restitution, under statute or otherwise, including under any indemnities, in each case howsoever caused including if caused by negligence) to Catapult in connection with any act and/or omission by COLLABORATOR to the extent that the liability arises from: |
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(a) |
any breach of the Data Protection Legislation by Catapult; or |
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(b) |
any breach by Catapult of its obligations under this Clause 36 |
During the Term and for a period of twelve (12) months following any termination or expiration of this Agreement, each Party agrees, on behalf of itself and its Affiliates, not to solicit for employment, employ or otherwise retain any employee of the other Party or its Affiliates except with the prior written consent of the other Party; provided, however, that it will not be a violation of the non-solicitation obligation of this Clause 37 (Non-Solicitation) if an employee of the other Party or its Affiliates responds to an indirect solicitation (e.g., advertisements in media of general circulation).
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Signature Page of Collaboration Agreement
AGREED by the Parties through their duly authorised representatives effective on the date written at the start of this Agreement:
For and on behalf of: Freeline Therapeutics Limited
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For and on behalf of: Cell Therapy Catapult Limited |
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Signed: |
/s/ Xxxxxxx X. Xxxxxx ..........................................…
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Signed: |
/s/ Xxxxxxx Xxxxx ............................................ |
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Full Name:
|
Xxxxxxx X. Xxxxxx ............................................ |
Full Name: |
Xxxxxxx Xxxxx ............................................ |
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Job Title: |
Director ............................................ |
Job Title: |
Chief Executive Officer ............................................ |
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Date: |
23 June 2021 ............................................ |
Date: |
23 June 2021 ............................................ |
END OF DOCUMENT