Document:

Exhibit 4.3

 

DESCRIPTION OF SECURITIES

REGISTERED PURSUANT TO SECTION 12 OF THE

SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

 

Twin Vee PowerCats Co. (the “Company,”
“we,” “us,” and “our”) has one class of securities registered under Section 12 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), which is our common stock, par value $0.001 per share (the “common
stock”).

 

General

 

The following is a description of the material terms
of our common stock. This is a summary only and does not purport to be complete. It is subject to and qualified in its entirety by reference
to our Certificate of Incorporation (the “Certificate of Incorporation”), and our Bylaws (the “Bylaws”), each
of which are incorporated by reference as an exhibit to our Annual Report on Form 10-K. We encourage you to read our Certificate of Incorporation,
our Bylaws and the applicable provisions of the Delaware General Corporation Law, for additional information.

 

Common Stock

 

Holders of shares of our common stock are entitled
to one vote for each share held of record on all matters submitted to a vote of stockholders. Except as otherwise provided in our amended
and restated certificate of incorporation or as required by law, all matters to be voted on by our stockholders other than matters relating
to the election and removal of directors must be approved by a majority of the shares present in person or by proxy at the meeting and
entitled to vote on the subject matter or by a written resolution of the stockholders representing the number of affirmative votes required
for such matter at a meeting. The holders of our common stock do not have cumulative voting rights in the election of directors.

 

Holders of shares of our common stock are entitled
to receive dividends when and if declared by our board of directors out of funds legally available therefor, subject to any statutory
or contractual restrictions on the payment of dividends and to any restrictions on the payment of dividends imposed by the terms of any
outstanding preferred stock.

 

Upon our dissolution or liquidation or the sale of
all or substantially all of our assets, after payment in full of all amounts required to be paid to creditors and subject to any rights
of preferred stockholders, the holders of shares of our common stock will be entitled to receive pro rata our remaining assets available
for distribution.

 

Holders of shares of our common stock do not have
preemptive, subscription, redemption, or conversion rights. There will be no redemption or sinking fund provisions applicable to the common
stock.

 

Forum Selection

 

Our Certificate of Incorporation provides that unless
we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will, to the fullest extent
permitted by applicable law, be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf; (ii) any
action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders;
(iii) any action asserting a claim against us, any director or our officers or employees arising pursuant to any provision of the Delaware
General Corporation Law (“DGCL”), our Certificate of Incorporation or our Bylaws; or (iv) any action asserting a claim against
us, any director or our officers or employees that is governed by the internal affairs doctrine, except, as to each of clauses (i) through
(iv) above, for any claim as to which the Court of Chancery determines that there is an indispensable party not subject to the jurisdiction
of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within ten
(10) days following such determination), which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery,
or for which the Court of Chancery does not have subject matter jurisdiction. The Certificate of Incorporation further provides that the
choice of the Court of Chancery as the sole and exclusive forum for any derivative action or proceeding brought on behalf of the Corporation
does not apply to suits to enforce a duty or liability created by the Securities Act of 1933, as amended, or the Exchange Act.

 

    	 

    	 

    

 

Anti-Takeover Provisions

 

Our Certificate of Incorporation and Bylaws contain
provisions that may delay, defer, or discourage another party from acquiring control of us. We expect that these provisions, which are
summarized below, will discourage coercive takeover practices or inadequate takeover bids. These provisions are also designed to encourage
persons seeking to acquire control of us to first negotiate with our board of directors, which we believe may result in an improvement
of the terms of any such acquisition in favor of our stockholders. However, they also give our board of directors the power to discourage
acquisitions that some stockholders may favor.

 

Section 203 of the Delaware General Corporation
Law. We are subject to Section 203 of the DGCL. Subject to certain exceptions, Section 203 prevents a publicly held Delaware corporation
from engaging in a “business combination” with any “interested stockholder” for three years following the date
that the person became an interested stockholder, unless the interested stockholder attained such status with the approval of our board
of directors or unless the business combination is approved in a prescribed manner. A “business combination” includes, among
other things, a merger or consolidation involving us and the “interested stockholder” and the sale of more than 10% of our
assets. In general, an “interested stockholder” is any entity or person beneficially owning 15% or more of our outstanding
voting stock and any entity or person affiliated with or controlling or controlled by such entity or person.

 

Classified Board of Directors. Our Certificate
of Incorporation divides our board of directors into staggered three-year terms. In addition, our Certificate of Incorporation and our
Bylaws provide that directors may be removed only for cause. Under our Certificate of Incorporation and our Bylaws, any vacancy on our
board of directors, including a vacancy resulting from an enlargement of our board of directors, may be filled only by the affirmative
vote of a majority of our directors then in office, even though less than a quorum of the board of directors. The classification of our
board of directors and the limitations on the ability of our stockholders to remove directors and fill vacancies could make it more difficult
for a third party to acquire, or discourage a third party from seeking to acquire, control of us.

 

Authorized but Unissued Shares. The authorized
but unissued shares of our common stock are available for future issuance without stockholder approval, subject to any limitations imposed
by the listing standards of the Nasdaq Stock Market. These additional shares may be used for a variety of corporate finance transactions,
acquisitions, and employee benefit plans. The existence of authorized but unissued and unreserved common stock could make it more difficult
or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger, or otherwise.

 

Stockholder Action by Written Consent. Our
Certificate of Incorporation and our Bylaws provide that any action required or permitted to be taken by our stockholders at an annual
meeting or special meeting of stockholders may only be taken if it is properly brought before such meeting and may be taken by written
consent in lieu of a meeting only if the action to be effected by such written consent and the taking of such action by such written consent
have been previously approved by the board of directors.

 

Special Meetings of Stockholders. Our Bylaws
also provide that, except as otherwise required by law, special meetings of the stockholders may only be called by our board of directors.

 

Advance Notice Requirements for Stockholder Proposals
and Director Nominations. In addition, our Bylaws establish an advance notice procedure for stockholder proposals to be brought before
an annual meeting of stockholders, including proposed nominations of candidates for election to our board of directors. In order for any
matter to be “properly brought” before a meeting, a stockholder will have to comply with advance notice and duration of ownership
requirements and provide us with certain information. Stockholders at an annual meeting may only consider proposals or nominations specified
in the notice of meeting or brought before the meeting by or at the direction of our board of directors or by a qualified stockholder
of record on the record date for the meeting, who is entitled to vote at the meeting and who has delivered timely written notice in proper
form to our secretary of the stockholder’s intention to bring such business before the meeting. These provisions could have the
effect of delaying stockholder actions that are favored by the holders of a majority of our outstanding voting securities until the next
stockholder meeting.

 

Amendment of Certificate of Incorporation or Bylaws.
The DGCL provides generally that the affirmative vote of a majority of the shares entitled to vote on any matter is required to amend
a corporation’s certificate of incorporation or bylaws, unless a corporation’s certificate of incorporation or bylaws, as
the case may be, requires a greater percentage. Our Bylaws may be amended or repealed by a majority vote of our board of directors or
by the affirmative vote of the holders of at least 66 2/3% of the votes which all our stockholders would be eligible to cast in an election
of directors. In addition, the affirmative vote of the holders of at least 66 2/3% of the votes which all our stockholders would be eligible
to cast in an election of directors will be required to amend or repeal or to adopt any provisions inconsistent with any of the provisions
of our certificate described in the prior three paragraphs.

 

    	 

    	 

    

 

Limitations on Liability and Indemnification of
Officers and Directors

 

Our Certificate of Incorporation and our Bylaws provide
indemnification for our directors and officers to the fullest extent permitted by the DGCL. In addition, as permitted by Delaware law,
our Certificate of Incorporation includes provisions that eliminate the personal liability of our directors for monetary damages resulting
from breaches of certain fiduciary duties as a director. The effect of these provisions is to restrict our rights and the rights of our
stockholders in derivative suits to recover monetary damages against a director for breach of fiduciary duties as a director, except that
a director will be personally liable for:

 

	 	●	any
    breach of his duty of loyalty to us or our stockholders;

 

	 	●	acts
    or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;

 

	 	●	any
transaction from which the director derived an improper personal benefit; or

 

	 	●	improper
    distributions to stockholders.

 

These provisions may be held not to be enforceable
for violations of the federal securities laws of the United States.

 

Dissenters’ Rights of Appraisal and Payment

 

Under the DGCL, with certain exceptions, our stockholders
will have appraisal rights in connection with a merger or consolidation of Twin Vee PowerCats, Inc. Pursuant to the DGCL, stockholders
who properly request and perfect appraisal rights in connection with such merger or consolidation will have the right to receive payment
of the fair value of their shares as determined by the Delaware Court of Chancery.

 

Stockholders’ Derivative Actions

 

Under the DGCL, any of our stockholders may bring
an action in our name to procure a judgment in our favor, also known as a derivative action, provided that the stockholder bringing the
action is a holder of our shares at the time of the transaction to which the action relates or such stockholder’s stock thereafter
devolved by operation of law.

 

Transfer Agent and Registrar

 

The transfer agent and registrar for our common stock
is Interwest Transfer Company, Inc. (also known as Direct Transfer LLC).

 

Trading Symbol and Market

 

Our common stock trades on The Nasdaq Capital Market
under the symbol “VEEE.”frln-ex420_2557.htm

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

 

 

 

 

	
	
 

 

COLLABORATION AGREEMENT  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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, Gunnels Wood Road, Stevenage, Herts SG1 2FX (“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, London, SE1 9RT, United Kingdom (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.
	
DEFINITIONS AND INTERPRETATION

	
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 Gunnels Wood Road, Stevenage, Herts, SG1 2FX. 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”). 

5

 

 

	
“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.

6

 

 

	
“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 Level 0 Ground Level 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..

7

 

 

	
“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.

8

 

 

	
“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.

 

	
“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.

9

 

 

	
“Module”
	
means the specific Manufacturing Space, the Manufacturing Office, and Non-Manufacturing Office each allocated by Catapult under this Agreement for COLLABORATOR’s occupation and use at the Centre for carrying out the Project shown shaded in red on the Plans, and which will include all fixtures and fittings and plant and machinery located within the Manufacturing Space, the Manufacturing Office and Non-Manufacturing Office, to be set out in the Schedule of Condition and Inventory of Module Fixtures and Fittings immediately prior to occupancy and appended as Schedule Error! Reference source not found..

	
“Necessary Consents”
	
means all planning permissions and all other consents, licences, permissions, certificates, authorisations and approvals whether of a public or private nature which will be required by any regulatory authority for the Permitted Use.

	
“Non-Manufacturing Office”
	
means the office space forming part of the Module allocated for COLLABORATOR’s use in Clause 3, the specifications for which are set out in Schedules Error! Reference source not found. and Error! Reference source not found..

	
“Office Hours
	
9am – 5.30pm (UK time) Monday to Friday (inclusive) but excluding bank holidays and public holidays in England. 

	
“On-boarding” or “On-boarding Project”
	
means part of the Establishment Inputs and a process completed by Catapult together with each Collaborator involving the risk assessment and regulatory oversight required to bring each Collaborator’s manufacturing processes and products into the Centre as more particularly set out at Schedule 6.

	
“Operational Forum”

 
	
means the forum in which COLLABORATOR, Other Collaborators, and Catapult will convene to discuss operations matters connected with the Centre as more particularly described in Clause 9.6 and Schedule Error! Reference source not found..

	
“PAL”
	
means personnel airlock.

	
“Parties”
	
COLLABORATOR and Catapult; “Party” shall mean either of them, and “Parties” shall mean both COLLABORATOR and Catapult.

10

 

 

	
“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).

 

	
“Quarter”
	
means a period of three months commencing on 1 January, 1 April, 1 July, or 1 October; and “Quarterly” shall be construed accordingly.

 

	
“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.

 

	
“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.

 

	
“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.

 

	
“Term Start Date”
	
means July 01 2021, being the date on which COLLABORATOR will occupy the Manufacturing Space under the terms of the Agreement.

 

	
“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.

 

13

 

 

	
“Year”
	
means the financial year ending 31 March.

	
1.2
	
In this Agreement, unless otherwise specified:

	
 
	
1.2.1
	
references to Clauses and Schedules are to the clauses of, and schedules to, this Agreement;

	
 
	
1.2.2
	
headings are for convenience only and do not affect the interpretation of this Agreement;

	
 
	
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;

	
 
	
1.2.4
	
unless the context otherwise requires, words in the singular will include the plural and vice versa; 

	
 
	
1.2.5
	
references to approvals or notices being “in writing” or “written” will include email; 

	
 
	
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

	
 
	
1.2.7
	
‘including’ means ‘including but not limited to’ and ‘include’ and ‘includes’ will be construed accordingly.

	
2.
	
CONDUCT OF THE PROJECT

The Parties will undertake the Project in accordance with the provisions of this Agreement.

	
3.
	
OCCUPATION OF THE MODULE

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.

	
5.
	
CENTRE SPECIFICATIONS 

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, 

14

 

 

		
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: 

	
 
	
6.2.1
	
the Building Management System (BMS);

	
 
	
6.2.2
	
the Quality Control Area HVAC

	
 
	
6.2.3
	
the electrical supply (single and three phase);

	
 
	
6.2.4
	
the boilers;

	
 
	
6.2.5
	
the chiller;

	
 
	
6.2.6
	
HVAC;

	
 
	
6.2.7
	
lighting – including emergency lighting;

	
 
	
6.2.8
	
back-up generator;

	
 
	
6.2.9
	
UPS systems;

	
 
	
6.2.10
	
door interlocks;

	
 
	
6.2.11
	
pharmaceutical grade gas supplies (air, oxygen, carbon dioxide and nitrogen);

	
 
	
6.2.12
	
CCTV;

	
 
	
6.2.13
	
fire alarm;

	
 
	
6.2.14
	
LN2 / Low level, temperature and oxygen monitors;

	
 
	
6.2.15
	
drainage; and

	
 
	
6.2.16
	
appropriate IT Infrastructure (including cable network, switches, and server rooms).

	
6.3
	
Where appropriate, Catapult has qualified the building, systems and equipment that form part of the Centre, and this has extended to installation qualification, operational qualification, and performance qualification of all GMP direct impacting systems and integral equipment (“Qualification”). The basis for this Qualification and results obtained as related to shared areas (including Shared Restricted Access Area) and the COLLABORATOR Module will be shared by Catapult with quality representatives for COLLABORATOR on request.

	
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:

15

 

 

		

	
 
	
6.4.1
	
Manufacturing Space and all additional air locks HVAC

	
 
	
6.4.2
	
Warehouse HVAC

	
 
	
6.4.3
	
Environmental Monitoring System (EMS) and environmental monitoring equipment (viable air sampler, non-viable particulate monitors); Technical area HVAC

	
 
	
6.4.4
	
Carbon dioxide system

	
 
	
6.4.5
	
Nitrogen gas system

	
 
	
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)

	
 
	
6.4.7
	
Oxygen system

	
 
	
6.4.8
	
Compressed air system

	
 
	
6.4.9
	
Cold room, fridges, freezers (Catapult will carry out PQ in conjunction with COLLABORATOR)

	
7.
	
PROCESS AND PRODUCT

	
7.1
	
VALIDATION

	
 
	
7.1.1
	
Process Validation is entirely the responsibility of COLLABORATOR.

	
 
	
7.1.2
	
Where COLLABORATOR has completed a Technology Transfer of COLLABORATOR Manufacturing Process to the Module, then COLLABORATOR Manufacturing Process Validation will be the sole responsibility of COLLABORATOR.

	
7.2
	
PROCESS AND PRODUCT AMENDMENT

	
 
	
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.

	
 
	
7.2.2
	
If after the Term Start Date, COLLABORATOR subsequently wishes to (i) introduce a modification to any COLLABORATOR Product or COLLABORATOR Manufacturing Process, or (ii) add a new COLLABORATOR Product or new COLLABORATOR Manufacturing Process to the Project, then these requests will be considered by Catapult in accordance with the procedure detailed in this Clause 7.2.2 and in meeting the requirements of the QTA.  Any of the preceding described variations, modifications or additions (as applicable) shall be a “Product or Process Modification/Addition”.

	
 
	
7.2.2.1
	
COLLABORATOR must notify Catapult in writing of its application for the Product or Process Modification/Addition (the “Notification”);

16

 

 

	
 
		

	
 
	
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

	
 
	
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.

	
 
	
7.2.3
	
Catapult will permit (i) new COLLABORATOR Product(s), and/or COLLABORATOR Manufacturing Process(es) or (ii) COLLABORATOR modification(s) to COLLABORATOR Product(s) or COLLABORATOR Manufacturing Process(es) if, in the reasonable opinion of Catapult:

	
 
	
7.2.3.1
	
The new or modified COLLABORATOR Product(s), and/or COLLABORATOR Manufacturing Process(es) meet the requirements of the QTA;

	
 
	
7.2.3.2
	
The proposed product(s) is/are not a restricted product listed at Clause 7.2.3.7;

	
 
	
7.2.3.3
	
It does not affect Catapult’s ability to comply with GMP or GMP Requirements;

	
 
	
7.2.3.4
	
It does not compromise the safety of the Centre, or that of any Other Collaborator;

	
 
	
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;

	
 
	
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

	
 
	
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): 

	
 
	
•
	
B Lactam Antibiotics;

	
 
	
•
	
Other highly sensitising antibiotics;

	
 
	
•
	
Pathogenic Organisms (Containment Level 3 or 4);

17

 

 

	
 
		

	
 
	
•
	
GMO 3 and above;

	
 
	
•
	
Radiopharmaceuticals;

	
 
	
•
	
Ectoparasiticides; or

	
 
	
•
	
Sources of ionising radiation (but excluding low energy laboratory scale X-irradiators which have been assessed and approved by Catapult).

 

	
8.
	
CONTRIBUTIONS 

	
8.1
	
A Risk and Capital Contribution will be charged throughout the Term calculated at the rate of [***] of each Contribution, except for the Facility Contribution and Business Rates Contribution. [***], if applicable, will be added to all Contributions.

	
8.2
	
Any changes to the Contributions (other than the Facility Contributions which are fixed for the Term) will be made by Catapult once per year taking into account the new annual budget which will be discussed at the Operational Forum.

	
8.3
	
COLLABORATOR will pay to Catapult the following contributions to the costs of the Collaboration:

	
 
	
8.3.1
	
subject to Clauses 8.1 to 8.2, from the Term Start Date, the Facility Contribution, payable [***] in advance; 

	
 
	
8.3.2
	
subject to Clauses 8.1 to 8.2, from the Term Start Date , one-fifth of the total annual costs chargeable against the modules on the Ground Level of the Centre in the form of business rates, payable [***] in advance (“Business Rates Contribution”).  The apportionment of business rates for modules on the Ground Level and Level 2 of the Centre is based on floor area of the modules.  The total Business Rates Contributions chargeable against all modules on Level 2 is [***] chargeable against all modules on the Ground Level;

	
 
	
8.3.3
	
the Activity Related Input Contributions as the costs of providing the Activity Related Inputs as they are incurred by COLLABORATOR;

	
 
	
8.3.4
	
subject to Clauses 8.1 to 8.2, from the Term Start Date, the Integral Input Contributions are payable by COLLABORATOR [***] in advance and calculated in accordance with the following provisions of this Clause 8.3.4:

	
 
	
(a)
	
estimated annual Integral Input Contributions payable by all Other Collaborators (who have projects in Ground Level Modules) until 31 March 2021 are as provided in Schedule Error! Reference source not found..

	
 
	
(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: [***]. 

18

 

 

	
 
		

	
 
	
(c)
	
“Full Occupation” of the Centre for a given Year is achieved when ten (10) or more modules at the Centre are in concurrent occupation for such full Year. From and including the Year commencing 1 April 2022 and only following the first achievement of Full Occupation, prior to the start of each Year for which Catapult anticipates that the Centre will be in Full Occupation Catapult will use the actual costs of providing the Integral Inputs to the Collaborators in the Centre during the most recent Year of Full Occupation to reasonably estimate the Integral Input Costs for such coming Year at Full Occupation (the “Full Occupation Integral Input Costs Estimate”), which it will provide to the Collaborators. COLLABORATOR will pay to Catapult a fixed proportion of those costs, such proportion to be a [***] share of the Full Occupation Integral Input Costs Estimate which will be COLLABORATOR’s Integral Input Contribution for such Year. For the sake of clarity, contributions for the differently specified modules on Level 2 in such a Year will be based on a [***] share of the Full Occupation Integral Input Costs Estimate.

	
 
	
(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. 

	
 
	
8.3.5
	
At the end of Term or any extension(s) thereof, COLLABORATOR will be responsible for all Catapult costs associated with the COLLABORATOR’s off-boarding.  The contributions payable to cover such costs as may be applicable at the time will be communicated to COLLABORATOR a minimum of three (3) months prior to the end of the Term.  Off-boarding activities include: (i) decontamination of the Manufacturing Space, including replacing all HEPA filters within the Manufacturing Space, (ii) re-qualifying the Manufacturing Space, (iii) any necessary remediation works following any modifications to the Module performed at COLLABORATOR’s request via an Additional Input Agreement, and (iv) any remediation works identified as being required to return the Module to the same state and condition (taking into account normal “wear and tear” usage), with all fixtures, fittings and equipment as were provided to it by Catapult as recorded in the Schedule of Condition and Inventory referred to at Schedule Error! Reference source not found..

	
 
	
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 

19

 

 

		
expertise. The cost of such supporting inputs are to be agreed through separate negotiation and contractual agreement.

	
8.5
	
Catapult undertakes to keep full and proper books of account and records relating to the Integral Input Contributions. In addition COLLABORATOR will be provided with the opportunity to comment on such planned expenditure and consensus  sought through participation in the Collaborator Forums (although for clarity, Catapult reserves its discretion in exercising its professional judgment in relation to making any final decisions with respect to the Integral Inputs and Integral Input Contributions and Activity Related Input Contributions, while being consistent with the objectives set out in the terms of reference for the Collaborator Forums, particularly with respect to maintaining a suitable level of services required for robust operation of a licensed facility suitable for late stage clinical and commercial manufacture of ATMPs in an economical way).  

	
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.

	
9.
	
CATAPULT INPUTS, FACILITIES AND SUPPORT

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 

20

 

 

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. 

	
9.1
	
Catapult will provide the following Integral Inputs: 

	
 
	
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;

	
 
	
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:

	
 
	
(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; 

	
 
	
(b)
	
If any MHRA Compliance Activity required as a result of COLLABORATOR activity in the Module or Centre impacts on any Catapult personnel, Other Collaborator personnel, Catapult activity within the Centre, Other Collaborator(s), or any part of the Centre other than the Module, then the interactions with the MHRA related to such activity will be led by Catapult and assisted by COLLABORATOR. During inspections, Catapult will be entitled to nominate representatives to coordinate and accompany all MHRA activity in this paragraph on Catapult's behalf; and

	
 
	
(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.

	
 
	
9.1.4
	
insurance as described in Clause 19.1;

	
 
	
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;

21

 

 

	
 
		

	
 
	
9.1.6
	
a managed reception within Office Hours, and the provision of a mechanism for COLLABORATOR to access the Module at any time;

	
 
	
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.;

	
 
	
9.1.8
	
support for IT Infrastructure; for the avoidance of doubt, this does not include applications support for COLLABORATOR;

	
 
	
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);

	
 
	
9.1.10
	
receipt of incoming patient material and starting material into the Centre within Office Hours;

	
 
	
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;

	
 
	
9.1.12
	
short term final product and drug substance storage subject to terms to be agreed;

	
 
	
9.1.13
	
out of hours call out system for all facilities alarms (bar the Manufacturing Space alarms);

	
 
	
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;

	
 
	
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;  

	
 
	
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;

	
 
	
9.1.17
	
Toilet provision and services in relation to toilets available for COLLABORATOR use;

	
 
	
9.1.18
	
Security input as required for general security of Centre;

	
 
	
9.1.19
	
program and relationship management;

	
 
	
9.1.20
	
kitchen areas and vending machines for snacks, hot and cold drinks within the Centre;

	
 
	
9.1.21
	
a dedicated secure, unfurnished Manufacturing Office and a Non-Manufacturing Office per Module; and

22

 

 

	
 
		

	
 
	
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;

	
9.2
	
Catapult will provide the following Activity Related Inputs:

	
 
	
9.2.1
	
perform environmental monitoring in the form of viable monitoring and non-viable particulate monitoring required to demonstrate maintenance of the appropriate environmental classifications, including undertaking remote non-viable sampling in the Manufacturing Space, provided that the COLLABORATOR is responsible for performing viable sampling in the Manufacturing Space which will then be processed by Catapult;

	
 
	
9.2.2
	
measured electrical power to the Manufacturing Space;

	
 
	
9.2.3
	
upon request of COLLABORATOR, Manufacturing Space decontamination;

	
 
	
9.2.4
	
a measured supply of pharmaceutical grade oxygen, nitrogen, carbon dioxide, and air;

	
 
	
9.2.5
	
routine maintenance for the air handling system, including ULPA and HEPA filter changes  

	
 
	
9.2.6
	
gowning for Catapult staff providing services to the Collaborators, (COLLABORATOR gowning is ordered by COLLABORATOR from Catapult warehouse stock); 

	
 
	
9.2.7
	
Leased telephone line with a data package from the supplier if required;

	
 
	
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.;

	
 
	
9.2.11
	
warehouse movements over and above a fair usage level (to be determined by Catapult from time to time)

	
 
	
9.2.12
	
access rights to IT systems required for COLLABORATOR activity within the module:  eQMS, LIMS, WMS; 

	
 
	
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

 

 

	
 
		
excursions, governance of Catapult generated GMP data provided to COLLABORATOR, providing GMP documentation to support Qualified Person certification of drug product;

	
 
	
9.2.14
	
engineering and maintenance support for COLLABORATOR’s operation within the Module.

	
9.3
	
Catapult provided the following Establishment Inputs as per the Establishment Input Statement dated 22 January 2018.  Catapult will provide further Establishment Inputs if requested by COLLABORATOR due to COLLABORATOR’s requirement to introduce a new COLLABORATOR Product or Process:

	
 
	
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

	
 
	
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.

	
9.4
	
Additional Inputs

Additional Inputs to be listed once the process is completed in accordance with Clause 9 (iii) above. 

	
9.5
	
Steering Committee

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.

	
9.6
	
Collaborator Forums

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

	
9.7
	
Centre Downtime

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.
	
COLLABORATOR RESPONSIBILITIES 

	
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;

	
 
	
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;

	
 
	
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;

	
 
	
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.

	
10.2
	
If Catapult’s performance of its obligations under this Agreement is prevented or delayed by any act or omission of COLLABORATOR, its agents, contractors or employees, Catapult will not be liable for any costs, charges or loss sustained or incurred by COLLABORATOR to the extent arising directly or indirectly from such prevention or delay.

	
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.

	
11.
	
BACKGROUND INTELLECTUAL PROPERTY

	
11.1
	
Subject to the provisions of this Agreement, COLLABORATOR hereby grants to Catapult a non-exclusive, fully paid-up, royalty-free, licence, under COLLABORATOR’s Background Intellectual Property solely to undertake the Project. 

	
11.2
	
Subject to the provisions of this Agreement, Catapult hereby grants to COLLABORATOR a non-exclusive, fully paid-up, royalty-free, licence, under Catapult’s Background Intellectual Property solely to undertake the Project. 

	
11.3
	
From the Termination Date, such licence granted under Clause 11.2 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, provided it is acknowledged that COLLABORATOR, at its own cost, will need to  procure the consents required to use any Third Party’s Intellectual Property forming any part of Catapult’s Background Intellectual Property for use outside the Centre.  By way of example only, and without limitation, forms of Catapult Background Intellectual Property which may include Third Party Intellectual Property for which Third Party consent may be required before use include: the Electronic Quality Management System (eQMS), the Laboratory Information Management System (LIMS), Warehouse Management System (WMS) and Environmental Monitoring System (EMS), at the Centre. The Parties  acknowledge that Catapult cannot procure the grant of such Third Party rights and that if COLLABORATOR does not procure such Third Party rights that Catapult accepts no liability whatsoever for claims resulting from breaches of any Third Party’s Intellectual Property resulting from COLLABORATOR’s failure to procure such rights and/or consents).

	
11.4
	
Notwithstanding the provisions of Clause 11.3 above, the licence under Clause 11.1 and Clause 11.2 will automatically terminate where Catapult terminates this Agreement pursuant to Clause 17.4, or COLLABORATOR terminates this Agreement pursuant to Clause 17.5.

	
11.5
	
This Agreement does not affect the ownership of any Intellectual Property in any Background Intellectual Property or materials of a Party.  Each Party will retain the sole and exclusive ownership rights in and to its Background Intellectual Property and except for the license granted to Catapult in Clause 11.1 and to COLLABORATOR in Clauses 11.2 and 11.3, nothing in this Clause 11 will be construed as giving to either Party any rights to use any Background Intellectual Property of the other Party other than as expressly granted by this Agreement. Each Party will treat the other Party’s Background Intellectual Property as Confidential Information belonging to that other Party.

	
12.
	
FOREGROUND INTELLECTUAL PROPERTY

	
12.1
	
All Foreground Intellectual Property excluding Catapult Foreground Intellectual Property (as defined in Clause 12.2 below), whether or not it is capable of being a Registered Right will be deemed to be the sole property of COLLABORATOR, regardless of which Party created such Foreground Intellectual Property. COLLABORATOR’s Foreground Intellectual Property will constitute Confidential Information belonging to COLLABORATOR. COLLABORATOR may take such steps as it may decide from time to time, and at its own expense, to register and maintain 

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).

	
12.2
	
All Foreground Intellectual Property that constitutes an Improvement to Catapult’s Background Intellectual Property will be owned by Catapult, regardless of which Party created such Foreground Intellectual Property (“Catapult Foreground Intellectual Property”). All Catapult Foreground Intellectual Property will constitute Confidential Information belonging to Catapult. Catapult may take such steps as it may decide from time to time, and at its own expense, to register and maintain any protection for the Catapult Foreground Intellectual Property, including filing and prosecuting patent applications. COLLABORATOR will ensure that its employees involved in the creation of any Catapult Foreground Intellectual Property give Catapult such assistance as Catapult may reasonably request in connection with the registration and protection of the Catapult Foreground Intellectual Property, including filing and prosecuting patent applications, and taking any action in respect of any alleged or actual infringement of the Catapult Foreground Intellectual Property (for clarity, any costs connected with such assistance will be borne by Catapult). Subject to COLLABORATOR meeting the conditions under Clause 11.3, enabling Catapult to grant a license to the Catapult Background Intellectual Property forming part of any Catapult Foreground Intellectual Property to be licensed to COLLABORATOR under this clause, Catapult grants to COLLABORATOR a non-exclusive, fully paid-up, royalty-free, worldwide, sub-licensable licence under the Catapult Foreground Intellectual Property to undertake the Project.

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.

	
12.4
	
To the extent that any of COLLABORATOR’s Foreground Intellectual Property is capable of prospective assignment, Catapult now assigns COLLABORATOR’s Foreground Intellectual Property to COLLABORATOR; and to the extent any of COLLABORATOR’s Foreground Intellectual Property cannot prospectively be assigned, Catapult will assign such COLLABORATOR Foreground Intellectual Property to COLLABORATOR as and when they are created, at the request of COLLABORATOR.

	
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.

	
13.
	
CONFIDENTIAL INFORMATION

	
13.1
	
The Receiving Party undertakes:

	
 
	
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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13.3
	
The Receiving Party shall be permitted to disclose the Disclosing Party’s Confidential Information solely where it is required to disclose (and so discloses) to the courts of any competent jurisdiction, or to any government regulatory agency or financial authority, provided that the Receiving Party shall (i) inform the Disclosing Party or Alternative Disclosing Party as soon as is reasonably practicable, and (ii) at the Disclosing Party’s or Alternative Disclosing Party’s request and expense seek to persuade the court, agency or authority to have the information treated in a confidential manner, where this is possible under the court, agency, or authority’s procedures, in which case, if the Confidential Information is treated in a confidential manner by the applicable court, agency or authority, such that it retains its confidential nature; and (iii) discloses the minimum amount of information required to comply with such order or directive, Clause 13.1 shall continue to apply to such Confidential Information.

	
13.4
	
The Receiving Party shall procure that all of its employees, officers, contractors, consultants, advisors, legal counsel, Affiliates and sub licensees pursuant to this Agreement (if any) who have access to any of the Disclosing Party’s or Alternative Disclosing Party’s information to which Clause 13.1 applies, shall be made aware of and subject to these obligations and shall be subject to undertakings of confidentiality at least as restrictive as Clause 13.1 and which apply to the Disclosing Party’s or Alternative Disclosing Party’s Confidential Information before being given access to the Disclosing Party’s or Alternative Disclosing Party’s Confidential Information, and the Receiving Party shall be liable to the Disclosing Party or Alternative Disclosing Party for any breach of its employees, officers, contractors, consultants, advisors, legal counsel, Affiliates or sub licensees of the terms of this Clause 13.

	
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 foster 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. 

	
13.7
	
Catapult (a) will procure that each Other Collaborator, and any other Third Party contractor or other business partner working under contract with Catapult or any Other Collaborator that has access to the Centre, has agreed with Catapult in writing to obligations of confidence equivalent to those set out in this Agreement in relation to COLLABORATOR’s Confidential Information (and COLLABORATOR’s Affiliates’ Confidential Information (and 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)) and (b) will procure that (wherever possible with respect to such Third Parties other than Other Collaborators, but in all cases for Other Collaborators) COLLABORATOR will be given a third party right to enforce such confidentiality provisions. 

29

 

 

		

	
13.8
	
For the purposes of this Agreement, Confidential Information shall also include any confidential information disclosed between COLLABORATOR and Catapult under (a) the Pre-existing CDA (defined in the definition of Confidential Information) and (b) Agreement 1.  In relation to Confidential Information disclosed under these prior agreements, the terms of this Agreement shall supersede the terms in those prior agreements.

	
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.

	
14.
	
WARRANTIES

	
14.1
	
All Party Warranties

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;

	
 
	
14.2.4
	
it will provide the Inputs with all reasonable care and skill and in any event in accordance with Applicable Law; and

	
 
	
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.

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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;

	
 
	
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.

	
14.4
	
Intellectual Property Warranties

Each Party represents, warrants, and undertakes to the other Party that:

	
 
	
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

	
 
	
14.4.2
	
it has not done and will not do nor agree to do during the continuation of this Agreement, anything that would be inconsistent with the exercise by the other Party of the rights granted to it under this Agreement.

	
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

	
 
	
14.5.4
	
as imposing any obligation on it to bring or prosecute actions or proceedings against third parties for infringement.

	
15.
	
INDEMNITY

	
15.1
	
COLLABORATOR agrees to indemnify, and hold Catapult and its Affiliates harmless from and against all costs, expenses, damages, losses, and liabilities (whether in contract, tort, misrepresentation, restitution, under statute or otherwise) (including reasonable attorney’s fees, and legal costs and expenses) (“Catapult Loss”) that Catapult and/or its Affiliates suffer or incur arising out of or in connection with:

31

 

 

		

	
 
	
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;

	
 
	
15.1.2
	
any claim or proceedings made, brought or threatened against Catapult 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 COLLABORATOR, its Affiliates, visitors, employees, agents,  contractors, or any Third Party permitted by Catapult to share occupation of the Module under COLLABORATOR’s supervision pursuant to Schedule Error! Reference source not found.; and

	
 
	
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.

	
15.4
	
Catapult agrees to indemnify, and hold COLLABORATOR and its Affiliates harmless from and against all costs, expenses, damages, losses, and liabilities (whether in contract, tort, misrepresentation, restitution, under statute or otherwise) (including reasonable attorney’s fees, and legal costs and expenses) (“COLLABORATOR Loss”) that COLLABORATOR and/or its Affiliates suffer or incur arising out of or in connection with:

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.

	
16.
	
LIMITATION OF LIABILITY 

	
16.1
	
Collaborating organisations occupying the Centre generally, and COLLABORATOR and Catapult in particular with respect to this Agreement, in choosing to employ the Centre as a base for GMP manufacturing activities accept and acknowledge a degree of risk inherent in any multi-mode, shared occupancy manufacturing facility and the nature of the biological processes undertaken within. Occasional unforeseen situations may arise associated with, for example utilities, equipment and associated processes that have the potential to disrupt or have a detrimental impact on processing, including on the COLLABORATOR Product(s), and/or the COLLABORATOR Manufacturing Process(es). 

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 Sue”), 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 Sue by COLLABORATOR against each such Other Collaborator or Catapult pursuant to the Contracts (Rights of Third Parties) Act 1999.   

	
 
	
16.1.2
	
With respect to each Other Collaborator that Catapult has obtained an enforceable Agreement Not to Sue 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) Act 1999, 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.

	
 
	
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. 

	
 
	
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.

	
16.4
	
Without prejudice to Clauses 16.1, 16.5 and 16.6 , the maximum aggregate Liability of Catapult which arises from any single event which occurs in any Year will be limited to [***] for any single event or a maximum of [***] for all events in aggregate which occur in any one year.

	
16.5
	
In no circumstance will any Party have any Liability to the other for any of the following types of losses (whether those losses arise directly in the normal course of business or otherwise): pure economic loss; loss of profits; loss of or damage to materials stored; loss of business; loss of revenue; loss of contract; loss or depletion of goodwill and/or business opportunity; loss of anticipated earnings or savings or like loss; wasted management, operational or other time.

	
16.6
	
Nothing in this Agreement limits or excludes any person’s liability to the extent that it may not be so limited or excluded by law, including any such liability for death or personal injury caused by that person’s negligence, or liability for fraud or fraudulent misrepresentation.

	
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.
	
DURATION AND TERMINATION

	
17.1
	
This Agreement, and the licences granted hereunder, will come into effect on the Effective Date and, unless terminated earlier in accordance with this Clause 17 or unless specified in the continuing obligations provisions of this Agreement as having continued effect, will continue in force until [***] (the “Term”), and on such date this Agreement will terminate automatically by expiry. 

	
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.

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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:

	
 
	
17.4.1
	
if the other Party is in material breach of this Agreement and, in the case of a breach capable of remedy within 90 days, the breach is not remedied within 90 days of the party receiving notice specifying the breach and requiring its remedy; or 

	
 
	
17.4.2
	
if (A) the other Party becomes insolvent or unable to pay its debts as and when they become due; or (B) an order is made or a resolution is passed for the winding up of the other Party (other than voluntarily for the purpose of solvent amalgamation or reconstruction); or (C) a liquidator, administrator, administrative receiver, receiver, or trustee is appointed in respect of the whole or any part of the other Party’s assets or business; or (D) the other Party makes any composition with its creditors; or (E) the other Party ceases to continue its business; or (F) as a result of debt and/or maladministration the other party takes or suffers any similar or analogous action in any jurisdiction.

	
17.5
	
Subject to COLLABORATOR’s compliance with Clause 18.1, COLLABORATOR may terminate this Agreement [***] written notice to Catapult. Such termination of this Agreement pursuant to this Clause 17.5 shall not be effective until COLLABORATOR has fully complied with the terms of Clause 18.1.

	
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.
	
Consequences of EARLY termination

	
18.1
	
COLLABORATOR recognises that considerable planning and advance preparation by Catapult is required to ensure timely COLLABORATOR occupation of the Module.  COLLABORATOR agrees that the amounts payable under this Clause 18.1 reasonably and proportionately seek to protect Catapult from the time cost associated with having a module unoccupied at the Centre and the cost of making an empty module available for a new Collaborator, and represent agreed consideration for COLLABORATOR to reserve the right to terminate this Agreement at will pursuant to Clause 17.5. Solely where COLLABORATOR serves notice of termination on Catapult pursuant to Clause 17.5:

	
 
	
18.1.1
	
effective before the Term Start Date, then COLLABORATOR will pay to Catapult [***]; or 

	
 
	
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):

	
 
	
18.2.1
	
the provisions of Clauses 8 (with respect to Contributions accruing up to and including the date of expiry or termination) 8.3.1, 8.3.5, 10.2, 10.3,  11.3 (subject to Clause 11.4), 11.4, 11.5, 12, 13, 15, 16, 18, 19.1 19.2, and 32 will remain in force; and

	
 
	
18.2.2
	
the Collaboration will terminate, subject to any subsisting and continuing obligations.

	
19.
	
Insurance

	
19.1
	
Catapult will take out with a reputable insurance company and maintain at all times during the Term professional indemnity, and public liability insurance including against all loss of and damage to the Module, the Centre, and injury to persons including death arising out of or in connection with this Agreement.  Such insurances may be limited in respect of one claim provided that such limit must be at least [***].  Catapult will continue to maintain Product liability insurance for a further [***] from the end of the Term. 

	
19.2
	
COLLABORATOR will take out with a reputable insurance company, and maintain at all times during the Term of this Agreement public and product liability insurance including against all loss of and damage to the Module and Centre, injury to persons including death arising out of or in connection with this Agreement, and against all loss of and damage to any COLLABORATOR owned equipment, or 

37

 

 

		
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.
	
ANTI-BRIBERY AND ANTI-CORRUPTION

	
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):

	
 
	
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;

	
 
	
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;

	
 
	
20.1.3
	
promptly notify the other Party of:

	
 
	
(a)
	
any request or demand for any financial or other advantage received by it (or that person); and 

38

 

 

	
 
	
(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

	
 
	
20.1.4
	
promptly notify the other Party of any breach of this Clause 20.

	
21.
	
PUBLICITY

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

	
22.1
	
The Parties acknowledge that Catapult is a ‘Research Organisation’ as defined under European Union (EU) legislation and has an obligation to ensure, and is subject to audits to demonstrate, that all activities it undertakes are compliant with EU state aid rules, including its activities under this Agreement.  The Parties therefore agree that, notwithstanding any other provision of this Agreement: 

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: 

 

	
If sent by post to:

 

Cell Therapy Catapult

12th Floor Tower Wing

Guy’s Hospital

Great Maze Pond

London

SE1 9RT

United Kingdom
	
If sent by post to:

 

Stevenage Bioscience Catalyst

Gunnels Wood Road

Stevenage

Herts

SG1 2FX

United Kingdom

 

39

 

 

		
	
 

For the attention of:

 

[***]

 
	
 

For the attention of:

 

[***]

 

With a copy to:

[***]

	
If sent by email, to: 

 

[***]

 
	
If sent by email, to: 

 

[***]

 

With a copy to:

[***]

 

 

	
23.2
	
Any notice so sent will be deemed to have been duly given: 

	
 
	
23.2.1
	
if sent by personal delivery or courier, on delivery at the address of the relevant Party;

	
 
	
23.2.2
	
if sent by prepaid post, five days after the date of posting; and

	
 
	
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.

40

 

 

		

	
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.

	
26.2
	
The following principles will be adhered to in the event a change is proposed by Catapult to 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), and Schedule Error! Reference source not found. (Module and Centre Specifications), and Clause 10 only:

	
 
	
26.2.1
	
If the proposed change has no material impact on the COLLABORATOR Product(s) or COLLABORATOR Manufacturing Process(es), or COLLABORATOR’s compliance with GMP guidelines, Catapult may enact the change by a written notification (signed by a member of Catapult’s Quality team) to COLLABORATOR, such written notification forming an amendment to this Agreement; and

	
 
	
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.

	
 
	
26.2.3
	
If COLLABORATOR disagrees with Catapult’s assessment that a change under Clause 26.2.1 has no material impact, it may serve written notice on Catapult confirming this and the matter will then be resolved through the use of the Expert Determination procedure under Schedule Error! Reference source not found..

	
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.

	
27.2
	
Either Party may assign and transfer all its rights and obligations under this Agreement to an Affiliate or to any company to which it transfers all or substantially all of its assets or business to which this Agreement relates, provided that the assignee undertakes to the other Party to be bound by and perform the obligations of the assignor under this Agreement.  However, COLLABORATOR’S right to assign pursuant to this Clause 27.2 will be subject to Catapult’s prior written consent, such consent not to be unreasonably withheld or delayed, and a Party will not have such a right to assign this Agreement if it is insolvent or any other circumstance described in Clause 17.4.2 applies to it.

	
27.3
	
Catapult will be entitled to sub-contract any of its obligations under this Agreement, provided that it will ensure any relevant obligations are passed on to such sub-contractor and Catapult will be responsible for the performance of such sub-contractor.  In the event Catapult changes its operating model from that in place on the Term Start Date such that it sub-contracts any additional material obligation not set out under this Agreement, Catapult will provide notice of the same to COLLABORATOR. 

41

 

 

		

	
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.  

	
30.
	
RELATIONSHIP OF THE PARTIES

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.
	
GOVERNING LAW AND JURISDICTION

	
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.
	
DISPUTE RESOLUTION PROCEDURE

	
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:

	
 
	
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 

42

 

 

	
 
		
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;

	
 
	
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.

	
34.
	
COUNTERPARTS

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.

	
35.
	
Force majeure

	
35.1
	
“Force Majeure Event” means any circumstance not within a Party's reasonable control including acts of God, flood, drought, earthquake or other natural disaster, epidemic or pandemic, terrorist attack, civil war, civil commotion or riots, war, threat of or preparation for war, armed conflict, imposition of sanctions, embargo, or breaking off of diplomatic relations; nuclear, chemical or biological contamination or sonic boom; any law or any action taken by a government or public authority, including imposing an export or import restriction, quota or prohibition, any labour or trade dispute, strikes, industrial action or lockouts and interruption or failure of utility service. 

43

 

 

	
35.2
	
If a Party is prevented, hindered or delayed in or from performing any of its obligations under this Agreement by a Force Majeure Event (“Affected Party”), the Affected Party shall not be in breach of this Agreement or otherwise liable for any such failure or delay in the performance of such obligations. The time for performance of such obligations shall be extended accordingly.  This Clause 35.2 shall not apply to any payment obligation of COLLABORATOR under this Agreement.

	
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.
	
DATA PROTECTION

	
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:

	
 
	
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;

	
 
	
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.

44

 

 

	
36.5
	
In so far as Catapult Processes any Personal Data on behalf of COLLABORATOR, Catapult shall:

	
 
	
36.5.1
	
Process the Personal Data on behalf of COLLABORATOR only to the extent necessary for performing this Agreement and only in accordance with the specific written instructions of COLLABORATOR (save to the extent that Catapult considers that such instructions infringe the Data Protection Legislation, in which case Catapult shall notify COLLABORATOR) or as required by any regulator or Applicable Law;

	
 
	
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);

	
 
	
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;

	
 
	
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;

	
 
	
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.

	
 
	
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;

	
 
	
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;

	
 
	
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 

45

 

 

	
 
		
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

	
 
	
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.

	
 
	
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;

	
36.6
	
In so far as Catapult Processes any Personal Data on behalf of COLLABORATOR, COLLABORATOR authorises Catapult to transfer such Personal Data outside of the European Economic Area on condition that Catapult shall: 

	
 
	
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 

	
 
	
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 

46

 

 

		
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:

	
 
	
(a)
	
any breach of the Data Protection Legislation by Catapult; or

	
 
	
(b)
	
any breach by Catapult of its obligations under this Clause 36

	
37.
	
NON-SOLICITATION

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).

 

 

47

 

 

 

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

 
	
For and on behalf of:

Cell Therapy Catapult Limited

	
Signed:
	
 

/s/ Theresa M. Heggie

.............................................

 
	
Signed:
	
 

/s/ Matthew Durdy

............................................

	
Full Name:

 
	
Theresa M. Heggie

............................................
	
Full Name:
	
Matthew Durdy

............................................

	
Job Title:
	
Director

............................................
	
Job Title:
	
Chief Executive Officer

............................................

	
Date:
	
23 June 2021

............................................
	
Date:
	
 23 June 2021

............................................

 

 

END OF DOCUMENT

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