Master Services Agreement, by and between the Registrant and Fujifilm Diosynth Biotechnologies UK Limited, Fujifilm Diosynth Biotechnologies Texas, LLC, Fujifilm Diosynth Biotechnologies U.S.A., Inc, and Fujifilm Diosynth Biotechnologies Denmark APS, dated February 24, 2021
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH [***]. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
(1) FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED
(2) FUJIFILM DIOSYNTH BIOTECHNOLOGIES TEXAS, LLC
(3) FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A., INC
(4) FUJIFILM DIOSYNTH BIOTECHNOLOGIES DENMARK APS
(5) VIGIL NEUROSCIENCE, INC.
MASTER SERVICES AGREEMENT
|Definitions and Interpretation||1|
|Appointment of Fujifilm||9|
|Performance of Programs||10|
|Quality and regulatory matters||11|
|Conforming batches, non-conforming batches, demonstration batches and engineering batches||13|
|Delivery, title and risk||14|
|Price and Payment||16|
|Intellectual Property Indemnity||24|
|Delay, Cancellation, Termination and consequences||28|
|Export/Import Controls and Sanctions Compliance||36|
|Modern Slavery and Corruption||38|
|Assignment and sub-contracting||39|
|Addresses for Notice||51|
THIS AGREEMENT is made on the date it is signed by the last signing party.
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED incorporated and registered in England and Wales with company number 05803359 whose registered office is at Belasis Avenue, Billingham, TS23 1LH, England (FDBK);
FUJIFILM DIOSYNTH BIOTECHNOLOGIES TEXAS, LLC incorporated and registered in Texas whose principal place of business is at 100 Discovery Drive, Suite 200 College Station, Texas 77845 United States of America (FDBT);
FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A., INC incorporated and registered in Delaware whose principal place of business is at 101 J Morris Commons Lane, Morrisville, North Carolina 27560, United States of America (FDBU);
FUJIFILM DIOSYNTH BIOTECHNOLOGIES DENMARK APS incorporated and registered in Denmark with company number 26060702 whose registered office is at Biotek Alle 1, 3400 Hillerød, Denmark (FDBD); and
VIGIL NEUROSCIENCE, INC. incorporated and registered in the State of Delaware having an address at 400 Technology Square, 10th Floor, Cambridge, MA 02139 (the Customer).
Fujifilm (as defined below) is a biopharmaceutical contract development and manufacturing organization. The Customer wishes to appoint Fujifilm to carry out development and manufacturing services in relation to certain of the Customers products.
Fujifilm and the Customer have agreed to work together on the terms and conditions contained in this Agreement.
DEFINITIONS AND INTERPRETATION
In this Agreement the following words have the following meanings unless inconsistent with the context:
|Affiliate||means in relation to an entity, each or any other entity who for the time being, that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with such entity. For purposes hereof (and clause 14.2), control shall mean: (a) holding the majority of the voting rights or share capital of such entity; (b) any power (whether direct or indirect and whether by the ownership of share capital, the possession of voting power, contract, or otherwise) to appoint|
|and/or remove all or such of the members of the board or other governing body of a body corporate as are able to cast the majority of the votes capable of being cast by members of that board or body on all, or substantially all, matters, or (c) otherwise to control or have the power to control the policies, management and affairs of that body corporate;|
|Ancillary Services||has the meaning given to it in Schedule 1 (Charges);|
|Applicable Laws||applicable law, regulations and binding guidance which applies in the jurisdiction in which the Program is being performed;|
|Background IP|| |
all Intellectual Property Rights controlled, owned or jointly owned by any party (or a third party on its behalf) prior to the Effective Date or developed independently from the Program. Fujifilms proprietary manufacturing, expression or purification technologies, including:
(a) an expression system within the scope of international patent application [***] (the pAVEway Expression System);
(b) expression technology within the scope of international patent application [***] (the Apollo Expression Technology); and
(c) Fujifilms proprietary alcohol oxidase yeast Pichia pastoris expression system (the Yeast Expression System),
(Fujifilm Expression Technology) is Fujifilms Background IP;
|Batch||a specific quantity of material produced in a process or series of processes. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.;|
|Batch Cancellation Fee||the Batch Cancellation Fee described in Schedule 1;|
|Batch Fee||if the Batch Fee is clearly described in the applicable SoW the Batch Fee for that SoW shall be the Batch Fee described in the SoW, however, if the Batch Fee is not clearly described in the applicable SoW it will be deemed to be, in respect of any Batch under that SoW, all agreed upon Charges for Fujifilm Services in respect of the Manufacturing Stages carried out in connection with that Batch;|
|Business Day|| |
(a) in relation to notices given under this Agreement rather than a specific Scope of Work a day other than a Saturday, Sunday or public holiday in England, the US, Denmark and/or the country in which the Customers head office is located; and
(b) in relation to notices given under a specific Scope of Work a day other than a Saturday, Sunday or public holiday in England if FDBK is a contracting party, the US if FDBT or FDBU is a contracting party, Denmark if FDBD is a contracting party and/or the country in which the Customers head office is located;
|cGMP||Current Good Manufacturing Practice as defined in (i) the Federal Register volume 66 No 186 and those sections applicable within the FDA Regulations 21 CFR Part 11, 210, 211, 600, 601 and 610 and (ii) the rules governing medicinal products in the European Union Eudralex Volume 4 Guidelines for good manufacturing practices for medicinal products for human and veterinary use. Part I Basic Requirements for Medicinal Products. Part II Basic Requirements for Active Substances used as Starting Materials and ICHQ7;|
|cGMP Batch||a Batch identified in a Scope of Work which is intended to be manufactured during a Manufacturing Stage and subject to Disposition in each case in accordance with cGMP;|
|Change||has the meaning given to it in clause 13;|
|Charges||has the meaning set out in clause 8.2;|
|Commercially Reasonable Efforts||with respect to the activities pursuant to a Program, the reasonable efforts and resources used by a reputable biopharmaceutical contract manufacturing organization for Drug Substances of similar nature, complexity and developmental stage in the same or similar circumstances;|
|Competitor||a contract development and/or manufacturing organization in the biopharmaceutical industry;|
|Confidential Information||the fact and terms of this Agreement and any Scope of Work, and all information (in whatever form) in respect of the business of each of the parties and each of its Affiliates including any ideas; business methods; finance; prices, business, financial, marketing or development plans; products or services, know-how or other matters connected with products or services manufactured and/or marketed; customer lists or details; computer systems and software; which is (in each case) provided or obtained by one party to or for the other;|
|Conforming Batch||a cGMP Batch which has been produced in accordance with cGMP, and which meets the Product Specification;|
|Consumable||a consumable item used or intended for use in a Program, including PEG, reagents (including analytical reagents), raw materials, packaging components, chromatography resins, filters, filtration membranes, media, buffer bags, refold bags, tubing, hoses, disposable analytical test kits, in-process measurement probes, columns (including analytical columns) and disposable containers;|
|Customer Foreground IP||all Foreground IP that constitutes an improvement or modification which is specific to the Customers Background IP, the Product or manufacture thereof;|
|Delay||has the meaning given to it in clause 14.1.1;|
|Demonstration Batch||a Batch which is manufactured in a non cGMP R&D facility for demonstration purposes and which is not intended for human use and is identified as such in the applicable SoW;|
|Deviation||a cGMP deviation as detailed in the Quality Agreement;|
|Disposition||the Stage during which (i) the Product is tested for compliance versus the Product Specification; (ii) all production instruction and analytical records relating to cGMP manufacture of each cGMP Batch prepared by Fujifilm are reviewed; and (iii) a Fujifilm recommendation for Product release or reject is made; in each case as applicable;|
|Drug Product||the final dosage form of product which contains Product in association with other active or inactive ingredients;|
|Drug Substance||Any substance or mixture of substances intended to be used in the manufacture of a Drug Product and that, when used in the production of a drug, becomes an active ingredient of the Drug Product. Such substances are intended to furnish pharmacological activity or other direct effect on the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.|
|Effective Date||February 11, 2021;|
|Engineering Batch||a Batch that is manufactured in a cGMP Facility at scale using the Process but which is not intended for human use and is identified as such in the applicable SoW;|
|Facility||any of Fujifilms manufacturing facilities in which a Program will be performed;|
|Force Majeure Event||any event or circumstances outside the reasonable control of a party affecting its ability to perform any of its obligations under this Agreement including act of God, fire, flood, severe weather, epidemic or pandemic, war, revolution, acts of terrorism, riot or civil commotion, acts of government, trade embargo, labor disputes (excluding labor disputes involving the party in question), interruption of utility service, restraints or delays affecting shipping or carriers, inability or delay in obtaining supplies of adequate or suitable materials, inability or delay in obtaining third party services, breakdown or failure in equipment or machinery, cyber-attack, currency restrictions but shall not include the failure of Drug Product in clinical trials or failure of Drug Product to gain regulatory approval;|
|Foreground IP||all Intellectual Property Rights that arise or are obtained or developed by or on behalf of any party in the course of the performance of a Program;|
|Fujifilm||FDBK, FDBT, FDBU and/or FDBD as the context requires in accordance with clause 1.3;|
|Fujifilm Foreground IP||all Foreground IP other than Customer Foreground IP;|
|Fujifilm Services||the research and development services to be provided by Fujifilm for the Customer during a Program as the same are described in the relevant Scope of Work excluding the Ancillary Services;|
|Gross Negligence||a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both;|
|Historic Documents||any historic contractual documentation which cover the same subject matter as a Program as incorporated by reference into the relevant SoW;|
|Indemnify||on demand to indemnify and keep indemnified, and hold harmless, the party to be indemnified on an after tax basis;|
|Intellectual Property Right||any current and future intellectual property rights and interests including patents, utility models, designs, design rights, copyright (including rights in software), decryption rights, database rights, trade marks, rights pursuant to passing off, service marks, business and trade names, domain names, know-how, results, data, databases, formulations, compounds, rights in biological or chemical materials, rights under data exclusivity laws, rights under unfair competition laws, topography rights, inventions, rights in confidential information (including technical and commercial trade secrets); supplementary protection certificates and image rights, and rights of a similar or corresponding character in any part of the world, in each case whether registered or not and including any application for registration and renewals or extensions of such rights in any country in the world and whether subsisting now or in the future;|
|Liabilities||any (i) liabilities of any nature, whether accrued, absolute, contingent or otherwise and whether in contract, tort (including negligence) or otherwise; (ii) losses, costs (including internal costs/overheads), damages, fines or expenses including reasonable legal fees; and (iii) claim, demand, proceeding, action or cause of action including those by third parties; in each case howsoever arising. Liability shall be construed accordingly;|
|Manufacturing Stage||a Stage of a Program during which production, testing and Disposition (if applicable) of Engineering Batches or cGMP Batches are intended to take place, including pre and post manufacturing activities; Facility changeover, setup, and cleaning before, between and after Batch manufacturing;|
|Modifications||a modification to a Facility; or equipment (including Process specific qualification and installation of existing equipment), required in order to perform a Process and detailed in the applicable Scope of Work;|
|Non-Conforming Batch||a cGMP Batch which has not been produced in accordance with cGMP and/or does not meet the Product Specification;|
|Non-Manufacturing Stage||a Stage of a Program, which is not a Manufacturing Stage, during which the non-manufacturing activities described in the relevant SoW are undertaken including the production and testing of Demonstration Batches;|
|Process||a particular process used, or to be used, for manufacture of a Product;|
|Process Specification||the Process operating parameters and specifications as documented in the regulatory submission and/or a QA Document which has been agreed by the parties for cGMP Batch production;|
|Process-Specific Consumable||a Consumable which is required to operate the Process and which is specific to the Process or a Consumable which is required in such large volumes as would not be possible for Fujifilm to consume during other manufactures and/or within the shelf life of such Consumable;|
|Process-Specific Equipment||an item of equipment which is required by Fujifilm to operate the Process and which is specific to the Process in addition to that equipment which Fujifilm uses in its Facilities as at the SoW Effective Date (which existing equipment is not already dedicated to other customer(s) of Fujifilm);|
|Product||the particular product or substance (compound or molecule) created during and as a result of performing the Process. The name of the relevant Product is identified in the applicable Scope of Work;|
|Product Specification||the Product specification, mutually agreed by the parties, which is documented in a QA Document;|
|Program||a program of work as set out in the applicable Scope of Work (or more than one Scope of Work, as the case may be) to be carried out by Fujifilm in accordance with the terms of this Agreement;|
|Program Cancellation Fee||the Program Cancellation Fee described in Schedule 1;|
|Program Manager||the Program manager appointed by each of Fujifilm and the Customer under the applicable SoW;|
|Program Plan||the Program plan controlled by Fujifilms Program Management and communicated to the customer from time to time;|
|Quality Agreement||the document agreed by the parties which sets out the mutually agreed quality standards applicable for any cGMP activity under the Program;|
|QA Documents||the Quality Agreement and the documents produced and approved in accordance with the Quality Agreement;|
|Regulatory Authority||the U.S. Food and Drug Administration, the European Medicines Agency, the Medicines & Healthcare products Regulatory Agency, the Danish Medicines Agency and any successor to any such entities;|
|Scope of Work or SoW||the document setting out the detail of the work to be undertaken by Fujifilm for the Customer;|
|SoW Effective Date||for each Scope of Work, the date that the Scope of Work is fully signed by all relevant parties;|
|Special Waste||waste or effluent which requires special handling including waste or effluent which is required to be collected in a special container (for example by tanker) for external disposal or which requires incineration;|
|Stage||a stage of the Program as described in the SoW;|
|Subcontracted Work||work subcontracted by Fujifilm under clause 21.3 but excluding any work subcontracted between FDBK, FDBT, FDBU and/or FDBD;|
|Tax||value added tax, sales tax or any other similar type of turnover tax; and|
|Willful Misconduct||a knowing violation of a reasonable and uniformly enforced rule or policy. It means intentionally doing that which should not be done or intentionally failing to do that which should be done, knowing that injury will probably result or recklessly disregarding the possibility that injury may result.|
In this Agreement (except where the context otherwise requires) any words following the terms including, include, for example or any similar expression are by way of illustration and emphasis only and shall not limit the generality or extent of any other words or expressions.
Each Scope of Work will be entered into by FDBK, FDBT, FDBU or FDBD or a combination of FDBK, FDBT, FDBU and/or FDBD and, subject to clause 18.3, each reference to Fujifilm or a party in this Agreement shall apply only to such of FDBK, FDBT, FDBU and/or FDBD as is carrying out the Program under the relevant Scope of Work. Whichever of FDBK, FDBT, FDBU and/or FDBD has entered into the Scope of Work in respect of that Program shall be fully and solely responsible for the obligations and liabilities of that party under the Scope of Work.
Insofar as this Agreement obliges any party to this Agreement to negotiate, take action or to do something, that party shall conduct such negotiations, take such action or do such thing in good faith and, in the case of Fujifilm, using Commercially Reasonable Efforts to achieve the result contemplated in this Agreement. There shall be a general obligation on the parties to act in good faith in relation to the matters contemplated in this Agreement.
In the case of conflict or ambiguity between terms of the main body of this Agreement, any Schedule to this Agreement or any other terms in any Scope of Work, the order of priority shall be as follows: (i) the main body of the Agreement; (ii) the Schedules to the Agreement; and (iii) the main body of the Scope of Work unless a Scope of Work specifically varies a provision of the Agreement or a Schedule to the Agreement by reference to the provision it is amending in which case the Scope of Work shall take precedence in that instance.
In the case of conflict or ambiguity between the terms of this Agreement or any specific Scope of Work and the terms of the QA Documents, the terms of the QA Documents shall prevail solely in relation to cGMP quality matters subject to clause 9.10.
Where a defined term is used in clause 9 (Liability) it shall retain its meaning even when the entire word that is a defined term is in capitals.
APPOINTMENT OF FUJIFILM
This Agreement establishes the general terms and conditions applicable to Fujifilms performance of each Program for the Customer and is structured so that a separate, numbered, Scope of Work (or in some cases multiple Scope of Works) shall be entered into by the parties for the provision of each Program.
The provisions of this Agreement shall apply to each Scope of Work and no Scope of Work shall be effective or binding on any party until it has been signed by an authorized representative of each contracting party.
Nothing in this Agreement or any Scope of Work shall oblige any party to enter into any Scope of Work and each Scope of Work constitutes a separate contract.
This Agreement shall come into force on the Effective Date and shall continue until terminated by a party in accordance with the terms of this Agreement.
A party may terminate this Agreement upon giving 3 (three) months written notice to the others, provided that there are no uncompleted Programs existing at the date such notice is given.
Each Scope of Work will take effect from the SoW Effective Date and shall continue until the earlier of:
the date specified in the Scope of Work, or if no such date is specified, the date the Program, or part of the Program referred to in the Scope of Work is completed; or
termination of this Agreement or the relevant Scope of Work in accordance with the terms of this Agreement.
PERFORMANCE OF PROGRAMS
Fujifilm shall carry out each Program, or parts of a Program, using Commercially Reasonable Efforts in accordance with:
the terms of this Agreement and any Scope of Work;
the Quality Agreement and cGMP (in both cases when applicable); and
the Process Specification for the applicable cGMP Batch (if any).
The parties agree that it shall not be considered a breach of this Agreement by Fujifilm if an objective of a Program is not achieved provided that Fujifilm has complied with its obligations set out in clause 4.1 and the cause of such non-achievement is [***]. Notwithstanding any contrary provisions in this Agreement, the parties acknowledge and agree that the services to be performed during the Programs are by their nature developmental and Fujifilm cannot (and consequently does not) guarantee to the Customer the achievement of a successful outcome for a Program, production of Conforming Batches or production of a specified volume of Product.
Each Scope of Work contains assumptions on which Fujifilms ability to perform the Program depends. If an assumption set out in the Scope of Work proves to be materially incorrect or actual circumstances materially differ from an assumption (including if such assumption cannot be met at such time as Fujifilm reasonably requires to enable it to perform its obligations) then the parties shall agree a Change to account for the change in assumption.
The Customer shall:
meet all its obligations and responsibilities under this Agreement, any Scopes of Work (including, in particular, any Customer dependencies set out in a Scope of Work) and the Quality Agreement;
comply with Applicable Laws; and
promptly provide all assistance, information, and advice and do all acts which Fujifilm may reasonably request to enable Fujifilm to comply with its obligations and responsibilities under this Agreement, any Scope of Work and the Quality Agreement.
QUALITY AND REGULATORY MATTERS
As soon as reasonably practicable following the Effective Date the parties shall execute the Quality Agreement (unless the Quality Agreement has already been executed prior to the Effective Date).
The Customer acknowledges that Fujifilm shall not commence any cGMP activity until the Quality Agreement is executed by both parties.
The Customer shall provide Fujifilm with a copy of the Customers Chemistry, Manufacturing and Controls section of any submission to a Regulatory Authority supporting the Customers regulatory filing activities for the applicable Drug Product or Process which relates to or contains information about the Process; the Facility (including Fujifilm equipment); the Fujifilm Services and/or the Ancillary Services (CMC Section) in accordance with the Quality Agreement. The Customer shall not submit a CMC Section without Fujifilms written approval in relation to any information regarding, or impacting, Fujifilm including any information regarding the Process, equipment, controls and analytics or any information provided to the Customer by Fujifilm related to or in accordance with the Quality Agreement.
During each Program the Customer may request assistance from Fujifilm in respect of the CMC Section, subject to payment by the Customer of a reasonable commercial rate for such assistance and Fujifilms reasonable expenses. However, no advice or assistance given by Fujifilm shall be deemed to be or construed as a guarantee that a Drug Product will receive regulatory approval.
Fujifilm will provide one electronic (PDF) copy of any documents which may be reasonably required by the Customer in support of its regulatory filing activities. If the Customer requires copies of the laboratory notebooks, provision of these will be subject to discussion and agreement by the parties and agreement of an additional fee associated with copying.
The Customer shall have the right and responsibility for determining regulatory strategy, decisions and actions relating to each Program and any Product and/or Drug Product subject to clause 5.2.5 and provided that Fujifilm shall have the right and responsibility for determining regulatory strategy, decisions and actions to the extent relating to:
the Facility (including in particular utilities and equipment);
Fujifilms quality systems, policies and internal procedures;
any requirement imposed on Fujifilm by a Regulatory Authority; or
any other commitments made by Fujifilm prior to the relevant SoW Effective Date of the applicable Program,
(each a Fujifilm Regulatory Responsibility).
The Customer acknowledges that Fujifilm Quality Assurance team reserves the right to Disposition Product to the Customer in accordance with the Quality Agreement.
The Customer shall not make any change to its regulatory filings, including its Investigational New Drug application, which may have an impact on any Fujifilm Regulatory Responsibility without prior written agreement with Fujifilm.
Each Party represents and warrants to the other that neither it nor any of its officers, directors, or its employees performing services under this Agreement has been debarred, or convicted of a crime which could lead to debarment, under the Generic Drug Enforcement Act of 1992, 21 United States Code §§335(a) and (b).
6. CONFORMING BATCHES AND NON-CONFORMING BATCHES
Each cGMP Batch will be determined to be a Conforming Batch or a Non-Conforming Batch.
Deviations will be handled in accordance with the Quality Agreement and, for the avoidance of doubt, the Customer acknowledges that the occurrence of a Deviation does not automatically mean that a Batch is a Non-Conforming Batch.
In respect of Conforming Batches, Fujifilm will complete Disposition, issue a certificate of analysis and a cGMP compliant statement. The provisions of clauses 6.1 and 6.6 shall apply to Non-Conforming Batches only.
If a Batch is a Non-Conforming Batch and the cause of that Batch being a Non-Conforming Batch is not a failure by Fujifilm to comply with clause 4.1 [***] then the Customer shall pay the Charges relating to the Non-Conforming Batch in full and the relevant Manufacturing Stage, Disposition and all related and ancillary activities shall be deemed to have been completed under the Scope of Work. Any further work in relation to the Non-Conforming Batch (such as analysis of the Batch) or manufacture of a replacement cGMP Batch shall be carried out at a time and price to be agreed in writing by the parties in a Change.
If a Batch is a Non-Conforming Batch and the cause of the Batch being a Non-Conforming Batch is a failure by Fujifilm to comply with clause 4.1 or caused by the Gross Negligence or Willful Misconduct of Fujifilm, its employees or contractors, then Fujifilm shall use Commercially Reasonable Efforts to manufacture a replacement cGMP Batch (Replacement Batch) as soon as is reasonably practicable. In these circumstances the Customer shall pay for:
all Charges in respect of the original Non-Conforming Batch in accordance with the SoW (save that any installments of the Charges which are not due until after the date that the Non-Conforming Batch is determined to be a Non-Conforming Batch shall become due on completion of the Replacement Batch); and
the Charges for the Ancillary Services provided in relation to the Replacement Batch but the Fujifilm Services provided in relation to the Replacement Batch shall be free of charge.
If the Customer requests delivery of a Non-Conforming Batch, the parties shall agree in writing (in a Change) on fair consideration payable for that Non-Conforming Batch. Fujifilm agrees to deliver a Non-Conforming Batch to the Customer on the express condition that it (i) will not be used for human or clinical trials; (ii) will be labeled as Not for Human Use; and (iii) is subject to the Customers indemnity given under clause 9.6.
DELIVERY, TITLE AND RISK
Delivery by Fujifilm to the Customer, or the Customers designee, of any material in connection with the Program including any quantity of Product manufactured during the Program, any Process-Specific Equipment and/or Process-Specific Consumables and return of any samples and cell lines supplied by the Customer (Materials) will be made Ex Works the Facility (Incoterms 2010) and clauses 7.2 to 7.6 shall apply to such Materials. Fujifilm shall package the relevant Material ready for shipment in accordance with the Customers reasonable instructions.
Delivery of Materials will be deemed to be complete on the date which Fujifilm makes the Materials available for collection by the Customer (which is the point of delivery as set forth in Ex Works (Incoterms 2010)) following notification, of at least [***], by Fujifilm to the Customer that it will make those Materials available for collection (the Delivery Date). For the avoidance of doubt, Product subject to Disposition will not be made available for collection by the Customer until Disposition is complete and Product for which a licence is required under clause 10.3 will not be made available for collection by the Customer until a licence has been signed by the parties.
If the Customer fails to collect Materials within [***] of the Delivery Date, Fujifilm will issue a further notice to the Customer specifying that the Materials will be destroyed if they are not collected within [***] from the date of the notice. If the Customer does not collect the Materials within that [***] period, Fujifilm may destroy the Materials at the Customers risk and expense.
Risk in Material shall pass to the Customer on the Delivery Date; save for risk in Product for which a licence is required under clause 10.3 in relation to which risk shall pass on the date on which Fujifilm notifies the Customer it would have made the Materials available for collection if a licence had been signed by the parties.
Title to the Product shall pass to the Customer on the Delivery Date.
Title to, and risk in, the Process-Specific Equipment and/or Process-Specific Consumables purchased by the Customer in accordance with Schedule 1 shall pass to the Customer when Fujifilm has received payment in full (in cash or cleared funds) for such items in accordance with paragraph 1.1 of Schedule 1 [***].
From time to time Fujifilm may agree to store Materials (including intermediate Product for future processing) for Customer. If Fujifilm agree to store Materials the parties will enter into a storage agreement on Fujifilms standard terms.
Delivery of any materials which the Customer is required to supply to Fujifilm pursuant to the SoW shall be delivered to Fujifilm DDP, the Facility (Incoterms 2010). Risk in those materials remains with the Customer [***].
PRICE AND PAYMENT
Under this Agreement, and the relevant Scope of Work, the Customer appoints Fujifilm to carry out services concerning the research and development, testing, manufacture and Disposition of the Product by Fujifilm under a Program. The Charges relate specifically to those services; and are not in consideration of the supply of any material (including Product) which Fujifilm may produce as a consequence of the performance of those services.
The Customer shall pay to Fujifilm for each Program:
the fees for the Fujifilm Services as set out in the relevant Scope of Work; and
the fees for Ancillary Services in accordance with Schedule 1, together the Charges.
Fujifilm may invoice the Customer for the Charges in respect of each Program in accordance with the terms set out in the Scope of Work and Schedule 1.
The Customer shall pay each invoice issued to it by Fujifilm within [***] of the date of invoice, in full and in cleared funds in the currency specified in the SoW by electronic transfer to the financial institution specified in the relevant invoice.
The Charges are exclusive of any Tax which may apply and which shall be payable by the Customer to Fujifilm at the rate prescribed by law.
If there is a change in the rate of Tax payable or in the Tax treatment of some or all of the services provided by Fujifilm or the Product, a change of law or practice or interpretation of the existing legislation or revised determination by HMRC (Her Majestys Revenue and Customs) or the IRS (Internal Revenue Service), then the
|Customer agrees that Fujifilm shall be entitled, where Tax is imposed on a supply by Fujifilm under or in connection with this Agreement, to invoice the Customer (in a valid Tax invoice) for a sum equal to the amount of the Tax which becomes due on that supply and any fees and/or interest which HMRC and/or the IRS levies on Fujifilm in relation to the outstanding sums and/or non-payment, unless such fees or interests arise directly from Fujifilms negligence or Willfull Misconduct. The Customer shall pay those invoices in accordance with clause 8.4.|
The Customer shall:
be responsible for the collection, remittance and payment of any or all taxes, charges, levies, assessments and other fees of any kind imposed by governmental or other authority in respect of the purchase, importation, exportation, sale or other distribution of any materials delivered to it by Fujifilm in connection with the Program; and
make all payments under this Agreement without withholding or deduction of, or in respect of, any tax unless required by law. If withholding tax is deducted then the Customer will provide all documentation required to enable Fujifilm to recover the tax withheld.
Without prejudice to any other right or remedy that it may have, if the Customer fails to pay any sum to Fujifilm on the due date for payment:
(except where the Customer has complied with its obligations in clause 8.9 below) the Customer shall pay interest on the overdue amount at the rate of [***] ([***] per cent) per month. Such interest shall be payable in respect of the period from the due date until actual payment of the overdue amount (whether before or after judgment) in accordance with clause 8.4; and
(except where the Customer has complied with its obligations in clause 8.9 below) Fujifilm may notify the Customer that if it does not pay Fujifilm will suspend work on the Program in respect of which payment is overdue, and if payment is not made within [***] of such notice, Fujifilm may suspend such work until payment has been made in full.
If the Customer disputes the payment of any Charges or a part of them, the Customer shall:
notify Fujifilm of the disputed amount within [***] of its receipt of the invoice in which such disputed amount is included giving reasonable details of the dispute; and
pay the amount of Charges not in dispute in accordance with clause 8.4, and the dispute shall be dealt with under the dispute resolution process set out in clause 16.
If the Customer fails to pay any sum which is not the subject of a bona fide dispute under clause 8.9 when the same is due in accordance with clause 8.4 then Fujifilm may elect, at its discretion, to treat such non-payment as a material breach of either the relevant SoWs under clause 14.5.1 or a material breach of this Agreement under clause 14.2.1.
A party shall not be entitled to withhold, set off or reduce payment of any amounts payable under this Agreement by any amounts which it claims are owed to it by another party under this Agreement or any other agreement.
Nothing in this Agreement limits or excludes the liability of any party to the other for any liability that is not permitted to be limited or excluded by law and clauses 9.2 to 9.7 are expressly agreed to be subject to this clause 9.1.
EXCEPT IN RESPECT OF BREACH BY FUJIFILM OF CLAUSE 12 (CONFIDENTIALITY) OR LIABILITY ARISING UNDER CLAUSE 11.1 (IPR INDEMNITY) AND SUBJECT TO CLAUSE 9.6.1, FUJIFILMS TOTAL LIABILITY, WHETHER OR NOT ARISING PURSUANT TO AN INDEMNITY, IN CONTRACT, TORT (INCLUDING NEGLIGENCE OR BREACH OF STATUTORY DUTY), MISREPRESENTATION, RESTITUTION OR OTHERWISE ARISING UNDER THIS AGREEMENT OR A SCOPE OF WORK OR IN CONNECTION WITH THE PERFORMANCE OR CONTEMPLATED PERFORMANCE OF THIS AGREEMENT OR A SCOPE OF WORK SHALL IN ALL CIRCUMSTANCES BE LIMITED AS FOLLOWS:
WHEN THERE HAS BEEN NO GROSS NEGLIGENCE OR WILLFUL MISCONDUCT BY FUJFILM: IN RESPECT OF ALL LIABILITY ARISING UNDER A SCOPE OF WORK, FUJIFILMS LIABILITY TO CUSTOMER SHALL BE LIMITED PER CALENDAR YEAR TO AN AMOUNT EQUAL TO THE CHARGES FOR FUJIFILM SERVICES PAID BY CUSTOMER IN RESPECT OF THAT SCOPE OF WORK DURING THAT CALENDAR YEAR; OR
WHEN THERE HAS BEEN GROSS NEGLIGENCE OR WILLFUL MISCONDUCT BY FUJFILM: IN RESPECT OF ALL LIABILITY ARISING UNDER A SCOPE OF WORK, FUJIFILMS LIABILITY TO CUSTOMER SHALL BE LIMITED PER CALENDAR YEAR TO AN AMOUNT EQUAL TO [***] OF THE CHARGES FOR FUJIFILM SERVICES PAID BY CUSTOMER IN RESPECT OF THAT SCOPE OF WORK DURING THAT CALENDAR YEAR; AND
IN RESPECT OF ANY OTHER LIABILITY RELATING TO THIS AGREEMENT, FUJIFILMS TOTAL LIABILITY TO CUSTOMER SHALL BE LIMITED PER CALENDAR YEAR TO [***] ([***]PER CENT) OF THE TOTAL CHARGES FOR FUJIFILM SERVICES PAID UNDER ALL SOWS IN FORCE DURING THAT CALENDAR YEAR.
UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), FOR BREACH OF STATUTORY DUTY OR OTHERWISE, ARISING UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR: LOSS OF PROFIT; LOSS OF BUSINESS; DEPLETION OF GOODWILL; LOSS OF ANTICIPATED SAVINGS; LOSS OR CORRUPTION OF DATA OR INFORMATION; OR ANY SPECIAL, INDIRECT, CONSEQUENTIAL LOSS, COSTS, DAMAGES, CHARGES OR EXPENSES, INCLUDING, IN THE CASE OF FUJIFILMS LIABLIITY, THE COSTS OF ANY RECALL OF THE PRODUCT OR DRUG PRODUCT. THE FOREGOING LIMITATION OF LIABILITY SHALL NOT BE CONSTRUED AS LIMITING A PARTYS INDEMFNICATION OBLIGATIONS UNDER THS AGREEMENT FOR CLAIMS MADE BY THIRD PARTIES.
Liability for Product and Drug Product: the Customer shall Indemnify Fujifilm from and against all Liabilities incurred by Fujifilm or its Affiliates arising out of or resulting from the use or resale of the Product or the Drug Product or any other deliverable arising out of the Program except when those Liabilities have arisen pursuant to Gross Negligence or Willful Misconduct of Fujifilm in which case Fujifilm shall bear such Liabilities up to the amounts for which Fujifilm is liable to the Customer under clause 9.2.2.
Liability for the Process: the Customer shall Indemnify Fujifilm from and against all Liabilities arising from third party claims incurred by Fujifilm or its Affiliates arising out of or resulting from the use or operation of the Process (or any part of the Process) except [***] to the extent that Fujifilm is liable under clause 11.1.
Liability for Non-Conforming Batches:
THE PROVISIONS OF CLAUSE 6 SHALL APPLY TO NON-CONFORMING BATCHES AND FUJIFILM SHALL HAVE NO LIABILITY IN RESPECT OF NON-CONFORMING BATCHES EXCEPT TO COMPLY WITH CLAUSE 6.
FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER (WHETHER AS TO COMPLIANCE WITH CGMP OR OTHERWISE) IN RESPECT OF NON-CONFORMING BATCHES OR THE USE BY THE CUSTOMER OF NON-CONFORMING BATCHES.
If the Non-Conforming Batch is delivered to the Customer pursuant to clause 6, the Customer shall fully Indemnify Fujifilm from and against all Liabilities incurred by Fujifilm or its Affiliates arising out of or resulting from the use of that Non-Conforming Batch.
The Customer uses any material produced in a Non-Conforming Batch at its own risk and shall undertake such tests as are necessary in order to satisfy itself that such materials are fit for the purposes for which the Customer proposes to use such materials.
Liability for Demonstration and Engineering Batches
FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER (WHETHER AS TO COMPLIANCE WITH CGMP OR OTHERWISE) IN RESPECT OF THE DEMONSTRATION BATCHES OR ENGINEERING BATCHES OR THE USE BY THE CUSTOMER OF AN ENGINEERING BATCH OR DEMONSTRATION BATCH.
FUJIFILM SHALL HAVE NO LIABILITY TO THE CUSTOMER IN CONNECTION WITH DEMONSTRATION BATCHES OR ENGINEERING BATCHES OR THE USE BY THE CUSTOMER OF THE DEMONSTRATION BATCHES OR ENGINEERING BATCHES.
The Customer shall fully Indemnify Fujifilm from and against all Liabilities incurred by Fujifilm or its Affiliates arising out of or resulting from the use of the Demonstration Batches or Engineering Batches.
The Customer uses any material produced in a Demonstration Batch or Engineering Batch at its own risk and shall undertake such tests as are necessary in order to satisfy itself that such materials are fit for the purposes for which the Customer proposes to use such materials. Customer expressly agrees that Product produced pursuant to a Demonstration Batch or an Engineering Batch is not suitable, and will not be used, for human consumption or use or in clinic trials.
FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER IN RESPECT OF ANY ADVICE OR ASSISTANCE GIVEN BY FUJIFILM IN CONNECTION WITH THE USE OF THE PRODUCT IN OR AS A DRUG PRODUCT (INCLUDING ADVICE OR ASSISTANCE RELATED TO ANY REGULATORY APPROVAL).
ALL WARRANTIES, CONDITIONS AND OTHER TERMS, EXPRESS (OTHER THAN THOSE SET OUT IN THIS AGREEMENT) OR IMPLIED, STATUTORY, CUSTOMARY OR OTHERWISE WHICH BUT FOR THIS CLAUSE 9 WOULD OR MIGHT SUBSIST IN FAVOR OF THE CUSTOMER, ARE (TO THE FULLEST EXTENT PERMITTED BY LAW) EXCLUDED FROM THIS AGREEMENT INCLUDING, IN PARTICULAR, ANY IMPLIED WARRANTIES RELATING TO MERCHANTABILITY, FITNESS FOR A PARTICULAR USE AND NON-INFRINGEMENT.
No claim for Liabilities incurred pursuant to the Quality Agreement may be made under the Quality Agreement by any party. Accordingly, performance of the Quality Agreement shall be deemed to be performance under the SoW to which the Quality Agreement relates and as such any breach of the Quality Agreement shall be deemed to be a breach of the relevant SoW and all Liabilities shall be construed and limited in accordance with this clause 9.
If the parties enter into a Scope of Work for stability or analytical services subject to this Agreement, the parties agree that such services shall are incidental and it is therefore reasonable that such Scope of Work may contain lower limits on Fujifilms Liability than are contained in this Agreement, in which case such limitation as set out in such Scope of Work shall apply to such Scope of Work.
Each party agrees to take all reasonable steps to mitigate any Liabilities that it may seek to claim from the other under or in connection with this Agreement including pursuant to any Indemnity.
If a party is entitled to benefit from an Indemnity (the Indemnified Party) from another party (the Indemnifying Party) in accordance with this Agreement (an Indemnity Claim), the Indemnified Party shall notify the Indemnifying Party in writing of the Indemnity Claim (providing all necessary details) and the Indemnifying Party shall at its own expense conduct all negotiations and any litigation arising in connection with the Indemnity Claim provided always that:
the Indemnifying Party shall consult the Indemnified Party on all substantive issues which arise during the conduct of such litigation and negotiations and shall take due and proper account of the interests of the Indemnified Party;
the Indemnifying Party shall not settle or compromise the Indemnity Claim without the Indemnified Partys prior written consent (not to be unreasonably withheld or delayed) and shall ensure that any settlement or compromise does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of the Indemnified Party;
the Indemnified Party shall not make any admissions or admit liability in relation to the Indemnity Claim or otherwise settle any Indemnity Claim without the written agreement of the Indemnifying Party; and
the Indemnified Party shall fully cooperate and assist the Indemnifying Party, at the Indemnifying Partys cost and expense, in relation to the Indemnity Claim (without limiting the extent of the Indemnity).
Each party shall maintain adequate insurance (which may be through self-insurance) to enable it to satisfy its Liabilities under this Agreement as they arise.
Subject to clause 10.2 and clause 10.7, no party shall acquire any right, title or interest in another partys Background IP.
The Customer grants to Fujifilm a royalty-free, worldwide licence to use Customers Background IP for the exclusive purpose of performance of the Program. Customer warrants that, to its knowledge, the use by Fujifilm (or its Authorized Third Parties) of Customers Background IP in accordance with this clause 10.2 shall not infringe any third partys Intellectual Property Rights.
Fujifilm shall not be obliged to deliver any materials (including any cell bank or cell paste) comprising Fujifilm Expression Technology unless and until a licence is granted in writing on terms to be agreed under the relevant Background IP. Fujifilm shall be entitled to charge the Customer for storage of any such materials which would have been delivered under clause 7.2 if a licence had been granted under this clause 10.3 until the time that such licence is granted. Customer acknowledges that storage may be at a third party storage facility unless Fujifilm and Customer have agreed in writing otherwise. Fujifilm shall not employ Fujifilm Expression Technology in a Process without Customers prior written consent.
All title to and all rights and interest in any Customer Foreground IP shall vest in Customer. Fujifilm hereby assigns to the Customer all title to and all rights and interest it owns in any Customer Foreground IP.
All title to and all rights and interest in any Fujifilm Foreground IP shall vest in Fujifilm. The Customer hereby assigns to Fujifilm all title to and all rights and interest it owns in any Fujifilm Foreground IP.
If requested to do so by another party, each party shall at the expense of the requesting party execute all documents and do all such further acts as the requesting party may reasonably require to perfect the assignment under clause 10.4 or 10.5.
Fujifilm grants to Customer a royalty free, non exclusive, worldwide licence to use the Fujifilm Foreground IP and Fujifilm Background IP other than Fujifilm Expression Technology employed in a Process for the exclusive purpose of manufacturing the Product.
11. INTELLECTUAL PROPERTY INDEMNITY
Fujifilm shall fully Indemnify the Customer from and against all Liabilities incurred by the Customer or its Affiliates arising out of any third party claim that Fujifilms use of Fujifilms Background IP or Fujifilm Foreground IP in performing the Program infringes such third partys Intellectual Property Rights.
The Customer shall fully Indemnify Fujifilm from and against all Liabilities incurred by Fujifilm or its Affiliates arising out of any third party claim that:
Fujifilms use of (i) materials provided by the Customer to Fujifilm or (ii) Customers Intellectual Property Right, in accordance with this Agreement; or
(excluding Liabilities in relation to which Fujifilm Indemnifies the Customer pursuant to clause 11.1) the development or manufacture of the Product and/or any other deliverables which are an output of the Program or the use of the Process in accordance with this Agreement, infringes such third partys Intellectual Property Rights.
If a third party claim is made in accordance with clause 11.1 or 11.2 then the Indemnified Party may require the Indemnifying Party to prove that it has adequate financial means to pay out under the indemnity provisions provided for in those clauses (for example by way of set aside capital or insurance). If the Indemnifying Party cannot so prove it has the financial standing to meet its obligations with respect to the Indemnities under the applicable clause then the Indemnified Party has the option to terminate this Agreement on written notice. If Fujifilm exercises its option to terminate under this clause 11.3 then (without prejudice to the survival of the relevant Indemnity obligations) such termination shall be treated as a termination under clause 14.3.2.
Each party (the Receiving Party) agrees with the other (the Disclosing Party):
to keep the Disclosing Partys Confidential Information confidential;
not to access or use the Disclosing Partys Confidential Information save for the purposes of:
complying with its obligations under this Agreement and each SoW;
complying with, or exercising its rights under, any confidentiality disclosure agreement then in force between the parties; or
undertaking activity by and between the parties to enable the parties to explore a new business opportunity involving the Customer and one or more of the other parties (New Opportunity);
not to disclose the Disclosing Partys Confidential Information to a third party other than to the Receiving Partys:
officers and employees and those of its Affiliates that need to know the Confidential Information for the purpose of performing its obligations under this Agreement or in relation to a New Opportunity;
contractors and sub-contractors, professional advisers, consultants and agents and those of its Affiliates who are engaged to advise that party in connection with the Program or this Agreement or in relation to a New Opportunity; and
any other person to whom the Disclosing Party agrees in writing that Confidential Information may be disclosed in connection with the Program,
the Authorized Third Parties. By way of clarification, Authorized Third Parties include the persons described above regardless of whether the Disclosing Party disclosed Confidential information to such persons or if Receiving Party discloses Confidential Information to such persons.
The Receiving Party shall procure that each of the Authorized Third Parties agree or are otherwise bound to written or professional confidentiality, nondisclosure and nonuse obligations substantially similar to those set forth in this clause 12 and shall remain primarily liable to the Disclosing Party for any act or omission of any of the Authorized Third Parties (including failure of such Authorized Third Parties to comply with such confidentiality, nondisclosure and nonuse obligations.
The Receiving Party shall within [***] of receipt of the Disclosing Partys written request (including after termination of this Agreement and any SoW):
deliver up to the Disclosing Party all items and copies of all or any Confidential Information of the Disclosing Party;
expunge and/or make irretrievable all Confidential Information of the Disclosing Party from any computer or other similar device in which it is stored and, if further requested, certify in writing signed by an authorized representative that it has done the same (provided that this clause 12.3.2 shall not apply to automatically archived electronic files or electronic back-ups made in the ordinary course of business, on secured central servers, which cannot reasonably be deleted and such electronic files shall be retained subject to the obligations of confidence set out in this clause 12); and
destroy all hard copies of notes, analyses or memoranda containing the Disclosing Partys Confidential Information (and, if further requested, certify in writing signed by an authorized representative that it has done the same)
provided that the Receiving Party shall be entitled to retain copies of the Confidential Information to enable it to monitor its obligations under this Agreement or which is required to be maintained by Applicable Laws or a Regulatory Authority subject always to the obligations of confidence under this Agreement.
Confidential Information shall not include information which:
is, or becomes, generally available to the public other than as a direct or indirect result of the information being disclosed by the Receiving Party or its Authorized Third Parties in breach of this Agreement (except that any compilation of otherwise public information in a form not publicly known shall still be treated as Confidential Information);
was available to the Receiving Party on a non-confidential basis prior to disclosure by the Disclosing Party;
was, is, or becomes available to the Receiving Party on a non-confidential basis from a person who, to the Receiving Partys knowledge, is not under any confidentiality obligation in respect of that information;
was lawfully in the possession of the Receiving Party without an obligation of confidentiality before the information was disclosed by the Disclosing Party
is developed by or for the Receiving Party independently of the information disclosed by the Disclosing Party;
is necessarily disclosed by the Receiving Party pursuant to a statutory or regulatory obligation, but then only to the extent of such required disclosure and save that the Receiving Party shall, to the extent it is lawful to do so, give prompt notice to the Disclosing Party of any such potential disclosure and allow the Disclosing Party a reasonable opportunity to limit such disclosure; or
the Disclosing Party and the Receiving Party agree in writing is not confidential.
Customer may use and disclose Confidential Information of Fujifilm solely to the extent necessary in communications with existing or prospective Customers investors, sub-licensees or commercial partners provided that: (a) such recipients are under obligations of confidentiality at least as restrictive as the terms of this clause 12; (b) none of the financial terms of the Agreement are disclosed to any such investor, sublicensee or commercial partner without the prior written consent of Fujifilm; (c) no disclosures are made to contract development and/or manufacturing organizations in the biopharmaceutical industry without Fujifilms prior written consent; and (d) such recipients are treated as Authorized Third Parties for the purposes of clause 12.2. Additionally, Customer shall notify Fujifilm of any disclosure to any investors, sub-licensees or commercial partners, including the name of the recipient and date and nature of disclosure.
If a party wishes to change (Change) any aspect of this Agreement or any Scope of Work (including if additional or different work is requested or required such as the production of a different number of Batches or if such work is required to be carried out at a different time or if actual circumstances differ from the assumptions set out in the Scope of Work (including if such assumptions cannot be met at all or in a timely fashion)) then Fujifilm shall draft a Change document using its standard format for that Change and the Change shall not be effective until the applicable Change document is signed by each party.
If the parties are unable to agree the terms of a Change and the dispute resolution process set out in clause 16 has been unsuccessfully exhausted Fujifilm may terminate the relevant SoW(s) and any cancellation or termination fees [***].
DELAY, CANCELLATION, TERMINATION AND CONSEQUENCES
If the Customer either causes or requests a delay to any Stage; Stages; or the Program as a whole and that delay prevents, or will prevent, Fujifilm from performing a Manufacturing Stage or the Program as a whole in accordance with the Program Plan (a Delay) and the parties cannot agree a Change to accommodate that Delay:
then either the Batch Cancellation Fee(s) or the Program Cancellation Fee (as applicable) shall be payable; and
the Batch Cancellation Fee or Program Cancellation Fee (as applicable) shall be calculated by reference to the date on which such written request was given by the Customer in relation to the Delay if such written request is given, or the date on which the Delay is caused, as determined by Fujifilm acting reasonably.
If the parties agree a Change to accommodate the Delay and that results in the Delayed Stage(s) or Program (as applicable) being performed partially within the original period reserved for the Delayed Stage(s) or Program as a whole, then the Batch Cancellation Fee(s) or the Program Cancellation Fee (as applicable) shall be reduced proportionally to reflect the period of time that the Program was Delayed (as determined by Fujifilm acting reasonably).
Termination of this Agreement as a whole
Fujifilm collectively or the Customer shall be entitled to terminate this Agreement (and all Scope of Works made under it) immediately upon giving notice to the other if:
the other party commits a material breach of this Agreement and such breach:
is not capable of remedy (a breach shall be considered capable of remedy if the party in breach can comply with the provision in question in all respects other than as to time of performance); or
is capable of remedy, [***] period after receipt of notice giving full particulars of the breach and requiring it to be remedied, provided, however, that (a) material breaches of clause 8.4 must be cured within [***] and (b) such cure period shall be suspended during any time that a party seeks resolution of a dispute as to whether an alleged material breach occurred pursuant to clause 16;
the other party takes any step or action in connection with its entering administration, provisional liquidation or any composition or arrangement with its creditors (other than in relation to a solvent restructuring), being wound up (whether voluntarily or by order of the court, unless for the purpose of a solvent restructuring), having a receiver appointed to any of its assets or ceasing to carry on business or, if the step or action is taken in another jurisdiction, in connection with any analogous procedure in the relevant jurisdiction;
the other party or the person controlling the other party has a change in control and the new controlling entity is reasonably considered by the party giving notice either to be its direct competitor or not to have reasonable financial creditworthiness.
Termination of a Stage/Program by the Customer for Convenience
The Customer may cancel a Non-Manufacturing Stage or Non-Manufacturing Program for convenience by giving written notice to Fujifilm in which case:
the SoW shall terminate in respect of that Stage if a Stage is being terminated but in all other respects the SoW shall continue in full force;
the SoW(s) in respect of that Program shall terminate if a Program as a whole is being terminated; and
the Customer shall pay Fujifilm the Charges that are due for the Fujifilm Services that have been performed and [***] of the Charges for the Fujifilm Services that have not yet been performed in that Non-Manufacturing Stage or Program (as applicable) [***] plus any Charges owed in respect of Ancillary Services.
The Customer may cancel any Manufacturing Stage for convenience by giving written notice to Fujifilm in which case:
the SoW shall terminate in respect of that Stage;
in all other respects the SoW shall continue in full force;
the Customer shall pay the Charges that are due for the Fujifilm Services that have been performed, the relevant Batch Cancellation Fee plus any Charges owed in respect of Ancillary Services.
The Customer may cancel a Program which includes Manufacturing for convenience by giving written notice to Fujifilm in which case:
the SoW(s) in respect of that Program shall terminate;
the Customer shall pay the Charges that are due for the Fujifilm Services that have been performed, the Program Cancellation Fee plus any Charges owed in respect of Ancillary Services.
If a critical Stage, or more than one Stage, under a Program which includes Manufacturing is cancelled and that has the effect of cancelling that Program as a whole (as determined by Fujifilm acting reasonably) then clause 14.3.3 shall apply instead of clauses 14.3.1 and/or 14.3.2.
Termination of a Program Due to Technical Issues.
Fujifilm may terminate a Program at any time up to completion of the Non-Manufacturing Stages by giving written notice to the Customer if Fujifilm reasonably believes that it will be unable to carry out and complete such Program in accordance with the Scope of Work(s) due to discovery of a factor (other than an breach by Fujifilm of clause 4.1) which:
adversely affects the development of the Process; or
adversely affects, or is likely to adversely affect, production of Product in the Facility when conducted in accordance with Fujifilms standard operating procedures or methods
is likely to have an adverse effect on a customers Product licence (being the licence authorising marketing of a medicinal product granted by a Regulatory Authority (also known as a Marketing Authorisation in Europe)) or Manufacturing Licence (being the licence to manufacture biotechnology-derived Drug Substances issued to Fujifilm by the applicable Regulatory Authority) as a result of the Product being introduced into the Facility and that customer was a customer of Fujifilm prior to the Program commencement,,
provided that, in each case, the factor was not known and could not reasonably have been known at the commencement of the applicable Program and provided further that Fujifilm has used commercially reasonable efforts in its attempts to address the factor prior to such termination.
If Fujifilm terminates a Program under clause 14.4.1 then the Customer shall pay the Charges that are due for the Fujifilm Services that have been performed and [***] of the Program Cancellation Fee plus any Charges owed in respect of Ancillary Services.
Termination of a Scope of Work for Breach
If any party commits a material breach of a Scope of Work, the non-breaching party may give written notice to the other party, specifying the nature of the material breach and, [***] after receipt of such notice (provided, however, that (a) payment obligations must be cured within [***] and (b) the cure period shall be suspended during any time that a party seeks resolution of a dispute as to whether an alleged material breach occurred pursuant to clause 16), then the non-breaching party shall have the right, in its sole discretion, to immediately terminate that Scope of Work.
If Fujifilm terminates a Scope of Work under this clause 14.5 or all Scopes of Work under clause 14.2 then, without prejudice to Fujifilms other rights and remedies, the Program Cancellation Fee shall be payable by the Customer to Fujifilm plus any Charges owed in respect of Ancillary Services.
If a party exercises any of its rights of termination in respect of only one or more SoWs then:
this Agreement shall terminate in respect of those SoWs and the provisions of this Agreement relating to termination of this Agreement shall apply in relation to those SoWs; and
in all other respects this Agreement shall continue in full force and those SoWs in respect of which the party has terminated this Agreement will be deemed to be removed from the definition of the SoWs.
Additional Consequences of Termination
The termination of this Agreement or any Scope of Work shall be without prejudice to the rights and remedies of any party which may have accrued up to the date of termination.
On termination of this Agreement or any SoW (as applicable) for any reason whatsoever:
save as set out in clause 10 the relationship of the parties shall cease and any rights or licenses granted under or pursuant to this Agreement shall cease to have effect save as (and to the extent) expressly provided for in this clause 14;
the provisions of the following clauses together with any provision which expressly or by implication is intended to come into or remain in force on or after termination shall continue in full force and effect clauses 1, 6 [***] 8, 9, 10, 11, 12, 14, 16, 18, and 23; and
the Customer shall immediately pay to Fujifilm all of Fujifilms outstanding unpaid invoices and interest and, in respect of Fujifilm Services and Ancillary Services supplied but for which no invoice has been submitted, Fujifilm may submit an invoice, which shall be payable immediately on receipt.
Based on conditions as of the Effective Date, Fujifilm has the capacity to undertake the anticipated Fujifilm Services under this Agreement. However, Fujifilm is unable to predict how the global COVID-19 pandemic (the Pandemic) may affect Fujifilms ability to perform its obligations set forth in this Agreement or a Scope of Work. Effects of the Pandemic, including staff shortages (either as a result of government recommended/mandated physical isolation or distancing or illness of our workers) and the inability to obtain required supplies or services, may require Fujifilm to alter the way its facilities operate after the Effective Date. As of the Effective Date, Fujifilm has a process to fairly address the needs of its various customers. However, Customer acknowledges and accepts that factors arising from the Pandemic may impact Fujifilms ability to perform its obligations under this Agreement or a Scope of Work for an indeterminate period of time, and as a result, the expected timing of performance of Fujifilm Services (or Ancillary Services) on behalf of Customer under a Scope of Work may need to be deferred upon notice to Customer by Fujifilm.
Subject to clause 15.33, no party shall be liable to the other(s) for any delay or non-performance of its obligations under any Scope of Work (except for the payment of money) arising from a Force Majeure Event.
If a party is delayed or prevented from performing its obligations due to a Force Majeure Event such party shall:
give notice of such delay or prevention due to the Force Majeure Event to the non-affected parties as soon as reasonably practical stating the commencement date and extent of such delay or prevention, the cause thereof and its estimated duration;
use reasonable endeavors to mitigate the effects of such Force Majeure Event, provided that such party shall not be required to procure materials or services at unreasonable prices or under unreasonable terms; and
resume performance of its obligations as soon as reasonably practicable.
If a partys delay or prevention due to the Force Majeure Event in question continues for more than [***] any party to the affected Scope of Work may give notice in writing to the other(s) to terminate that Scope of Work. The notice to terminate must specify the termination date, which must not be less than [***] after the date on which the notice is given, and once such notice has been validly given, that Scope of Work will terminate on that termination date.
Quality Disputes: If there is a dispute in relation to or in connection with the QA Documents, such dispute shall be dealt with in accordance with the procedures set out in the Quality Agreement.
In respect of any dispute concerning this Agreement (other than a dispute in connection with the QA Documents) the parties shall seek to resolve the matter as follows:
by referral in writing summarizing the nature of the dispute by a party in the first instance to the decision of each partys Program Manager;
if the dispute is not resolved within [***] of its referral to the Program Managers it shall be referred to the decision of Fujifilms Chief Business Officer and the Customers Chief Executive Officer; and
if the dispute is not resolved within [***] of its referral to Fujifilms Chief Business Officer and the Customers Chief Executive Officer it shall be referred to the decision of each partys President or Chief Executive Officer (as applicable/appropriate).
Any dispute, claim or controversy arising out of or relating to this Agreement or the breach, termination, enforcement, interpretation or validity thereof (including all issues or disputes regarding the existence, validity, scope or applicability of this agreement to arbitrate, the arbitrability of any claims, and the proper parties to the arbitration) shall be determined by arbitration in New York, New York and the arbitration shall be administered by JAMS pursuant to its Comprehensive Arbitration Rules and Procedures
before three arbitrators. Judgment on the Award may be entered in any court having jurisdiction.
General: Notwithstanding the provisions of this clause 16 any party may commence or take proceedings or seek remedies before the courts or any other competent authority for interim, interlocutory or injunctive remedies in relation to this Agreement.
The Customer may carry out quality audits at the times, and in accordance with the terms, set out in the Quality Agreement provided that access by the Customer and/or its representatives to records, information and systems shall be on a supervised basis, subject to the Customer complying with security and confidentiality requirements of Fujifilm to protect information which relates to anything other than the Programs and shall be limited to a maximum of [***] people for [***].
Audit access shall not be extended to confidential records which [***].
If Fujifilm is in material breach of clause 4.1.3 of this Agreement or if the Customer reasonably believes that Fujifilm is in material breach of clause 4.1.3 of this Agreement, the Customer may upon giving reasonable written notice to Fujifilm carry out an audit on the same basis as in clauses 17.1.1 and 17.1.2.
Additional audits (other than those carried out pursuant to clause 17.1.3) may be carried out on the same basis as in clauses 17.1.1 and 17.1.2 subject to (i) payment of Fujifilms costs and expenses and the agreement of a commercial rate; and (ii) the Customer ensuring such audit will not delay or disrupt Fujifilms operations at the Facility.
Subject to clause 18.2 the parties may communicate with each other in any way that is normal in the course of their business.
Any notice required to be given under clauses 3, 8, 9, 11, 12, 14, 15, 16, 17, 18.2, 19, 20 or 21 shall only be effective if it is in writing, sent to a party at its address or email address and for the attention of the individual, as set out in Schedule 2 (or such other address, email address or individual as that party may notify the other in accordance with this clause 18) and is given in accordance with clauses 18.31.1 to 18.5 below.
Where a notice must be given to Fujifilm under clauses 3.2, 14 or 21.2 such notice must be given to FDBK, FDBT, FDBU and FDBD.
Notice may be given by hand or sent by email, recorded delivery, registered post or airmail and will be deemed to have been duly served:
if delivered by hand, at the time and date of delivery;
if sent by email, at the time and date of sending;
if sent by recorded delivery or registered post, [***] from the date of posting (such date as evidenced by postal receipt); and
if sent by registered airmail, [***] from the date of posting,
provided that, where in the case of delivery by hand or transmission by email, such delivery or transmission occurs either after 4.00pm on a Business Day, or on a day other than a Business Day, service will be deemed to occur at 9.00am on the next Business Day.
In proving service of a notice it will be sufficient to prove that delivery was made or that the envelope containing the notice or document was properly addressed and posted (either by prepaid first class recorded delivery post or by prepaid airmail, as the case may be) or that no failed delivery message was received, as the case may be.
19. EXPORT/IMPORT CONTROLS AND SANCTIONS COMPLIANCE
The Customer shall at all times during the term of this Agreement comply with applicable Sanctions or Export/Import Laws and ensure that it has in place appropriate controls and safeguards to prevent any action being taken by it that would amount to or result in a violation of or non-compliance with any Sanctions or Export/Import Laws.
The Customer shall provide all information that Fujifilm may reasonably require from time to time in order for Fujifilm to assess and/or manage its compliance with Sanctions and Export/Import Laws (including provision of end-user statements or applicable Authorizations and notifying Fujifilm of any restrictions or export compliance obligations prior to providing Fujifilm access to controlled information/technology).
The Customer will not directly or indirectly use, sell, dispose of, (re)export, transship or otherwise transfer any Product, software, technology or Confidential Information: (i) unlawfully to any country in respect of which a Sanctions Authority maintains Sanctions or a Sanctioned Person; (ii) in a manner that would expose Fujifilm to the risk of negative consequences under Sanctions; or (ii) in violation of Export/Import Laws.
If any Authorization is required so that the performance of a Program does not contravene any Sanctions or Export/Import Laws, the Customer will at its own cost and expense obtain that Authorization and Fujifilm shall provide any commercially reasonable assistance (including reasonable information) that the Customer may require for the purposes of obtaining that Authorization. The Customers rights and Fujifilms obligations under this Agreement or any SoW in relation to that Program shall immediately be suspended if any required Authorization is not obtained. In the event that the Customers rights and Fujifilms obligations are suspended for more than [***] calendar days, a Program may be terminated immediately by Fujifilm giving written notice to the Customer. If Fujifilm terminates a Program under this clause 19.4 then the Customer shall pay the Charges that are due for the Fujifilm Services that have been performed during that Program and [***] of the Program Cancellation Fee plus any Charges owed in respect of Ancillary Services.
The Customer shall Indemnify Fujifilm against any and all Liabilities which Fujifilm incurs as a result of the Customers non-compliance with the terms of this clause 19.
In this clause 19 the following terms have the following meanings:
|Authorization||all consents, licences, authorisations, approvals, permissions, registrations, certificates and clearances and any precondition in any relevant jurisdiction;|
|Export/Import Laws||(a) any laws of the United States of America, the United Kingdom, the European Union or of any of its Member States or Japan that relate to the control of (re)export, transfer or import of Products, software or technology and technical data; or (b) any other (re)export, transfer or import controls or restrictions imposed or adopted by any government, state or regulatory authority in a country in which obligations under this Agreement are to be performed;|
|Sanctions||any economic, financial, trade or other sanction, embargo, import or export ban, prohibition on transfer of funds or assets or on performing services or equivalent measure imposed by any Sanctions Authority or by the laws of any state or any union of states from time to time;|
|Sanctions Authority||means (a) the Security Council of the United Nations, (b) the Organization for Security and Co-operation in Europe (c) the United Kingdom, (d) the European Union, (e) any Member State of the European Union, (f) the United States of America, (g) Japan (h) the governments and official institutions or agencies of any of paragraphs (a) to (h) above and (i) any other regulatory body imposing or enforcing sanctions legislation in any country or territory from which or into which the Customer is exporting or importing; and|
|Sanctioned Person||any person who appears on or is owned, operated or controlled by any person who appears on any list issued or maintained by any Sanctions Authority or is referred to in any list or public announcement issued by any Sanctions Authority, in each case as amended, supplemented or substituted from time to time.|
20. MODERN SLAVERY AND CORRUPTION
Each party shall endeavour to hold itself and its suppliers to the highest performance, ethical and compliance standards, including basic human rights, not engaging in any activity, practice or conduct which would constitute an offence under anti-slavery legislation in the United Kingdom, the U.S.A or Denmark, encouraging fair and equal treatment for all persons, the provision of safe and healthy working conditions, respect for the environment, the adoption of appropriate management systems and the conduct of business in an ethical manner. In performing its duties under this Agreement, each party acknowledges the value and importance of performance and ethical behaviour in its performance under this Agreement.
Each party warrants that on the Effective Date and each SoW Effective Date, it, its directors, officers or employees have not offered, promised, given, authorized, solicited or accepted any undue pecuniary or other advantage of any kind (or implied that they will or might do any such thing at any time in the future) in any way connected with this Agreement or a SoW and that it has taken reasonable measures to prevent subcontractors, agents or other third parties, subject to its control or determining influence, from doing so.
The parties agree that, at all times in connection with and throughout the term of this Agreement, they will comply with and that they will take reasonable measures to ensure that their subcontractors, agents or other third parties will comply with all applicable anti-corruption legislation including the Bribery Act 2010, the Foreign Corrupt Practices Act 1977 and the Danish Criminal Code.
Each party shall not do, or omit to do, any act that would cause one of the other parties to be in breach of any anti-corruption legislation including the Bribery Act 2010, the Foreign Corrupt Practices Act 1977 and the Danish Criminal Code.
ASSIGNMENT AND SUB-CONTRACTING
A party may assign or transfer all of its rights and responsibilities under this Agreement to:
an Affiliate provided that such Affiliate has reasonable financial creditworthiness; or
a purchaser of all or substantially all of the equity of the assigning party provided that such third party has reasonable financial creditworthiness and is not a Competitor; or
a purchaser of all or substantially all of assets to which this Agreement relates provided that such third party has reasonable financial creditworthiness and is not a Competitor; or
an exclusive licensee of the Product provided that such third party has reasonable financial creditworthiness and is not a Competitor,
but not otherwise without written consent of the other parties (such consent not to be unreasonably withheld or delayed) and provided that (a) the assignee agrees in writing to assume all obligations undertaken by its assignor in this Agreement and (b) in relation to assignment in part no such assignment shall relieve the assigning party of responsibility for the performance of any of its obligations under this Agreement.
If a party assigns or transfers all or any of its rights and responsibilities under clause 21.1 it shall immediately notify the other parties in writing.
Fujifilm may sub-contract all or any of its obligations under this Agreement provided that in relation to any subcontract manufacture, processing or handling of Product, Fujifilm will obtain the Customers written consent (which may be by signature of the relevant SoW(s) which specify that an obligation will be sub-contracted).
The appointment of any subcontractor shall not relieve the party sub-contracting from any liability or obligation under this Agreement and the party sub-contracting shall be responsible for all acts and omissions of the subcontractor to the same extent as if they were its own acts or omissions.
Entire agreement: This Agreement and the Historic Documents contain all the terms which the parties have agreed with respect to their subject matter and supersede all previous agreements and understandings between the parties (whether oral or in writing) relating to such subject matter. Each party acknowledges and agrees that it has not been induced to enter into this Agreement by a statement or promise which it does not contain. Each party confirms that save as otherwise expressly set out in this Agreement and the Historic Documents, the other party gives no warranties either in this Agreement or elsewhere in connection with the provision of the Programs. Nothing in this clause 22.1 shall exclude or limit a partys liability for fraud, including fraudulent misrepresentation.
Third party rights: Save as expressly set out in this Agreement, the parties do not intend that any person who is not a party to this Agreement shall have any right to enjoy the benefit or enforce any of the terms of this Agreement.
Variations: With the exception of Changes, which shall be subject to clause 13, no variation of this Agreement shall be valid unless in writing and signed by a duly authorized representative of each of the parties. A party is entitled to assume that a representative of another party is authorized to act on that partys behalf if that individual is apparently or seemingly acting in the normal course of the business relationship. An exchange of emails shall not be capable of constituting an agreement to vary this Agreement.
Waiver: No failure or delay by a party to exercise any right or remedy provided under this Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. The single or partial exercise by any party of any right, power or remedy under this Agreement shall not in any circumstances preclude any other or further exercise of it, or the exercise of any right, power or remedy. A waiver by any party of a breach of any provision of this Agreement shall not be considered as a waiver of a subsequent breach of the same or any other provision of this Agreement.
Severability: If any provision of this Agreement or a SoW is found by any court or administrative body of competent jurisdiction to be invalid, illegal or unenforceable in any jurisdiction then it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible that provision shall be deemed to be omitted from this Agreement or the SoW in so far as this Agreement or that SoW relates to that jurisdiction and the validity and enforceability of that provision in other jurisdictions and the other provisions of this Agreement or SoW shall not be affected or impaired.
This Agreement may be executed in any number of counterparts. Any party may enter into this Agreement by executing a counterpart and all the counterparts taken together will constitute one and the same agreement. This Agreement shall not be effective until each party has signed one counterpart.
Transmission of an executed counterpart of this Agreement (but for the avoidance of doubt not just a signature page) by email (in PDF, JPEG or other agreed format) shall take effect as delivery of an executed counterpart of this Agreement.
Publicity: The parties anticipate that there may be opportunities for joint or independent press releases or other announcements relating to the activities contemplated hereby. Notwithstanding the foregoing, no party shall use the name of the other party(ies) or the names of the employees of the other party(ies) nor disclose the terms of this Agreement or any SoW in any press releases, advertising or sales promotional material or in any publication without prior written permission of such party(ies). Such consent shall not be unreasonably withheld. This provision shall not restrict a partys ability to use the other parties names and to disclose the terms of this Agreement or a SoW to the extent, in the reasonable opinion of such partys legal counsel, required by law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such party has its securities listed or traded. In the event that such disclosure is required as aforesaid, the disclosing party shall make reasonable efforts to provide the other parties with at least [***] Business Days advance notice and to coordinate reasonably with the other parties with respect to the wording and timing of any such disclosure, subject to the requirements of such securities laws.
23. GOVERNING LAW
The formation, existence, construction, performance, validity and all aspects whatsoever of this Agreement (including any Scopes of Work) or any term of it and any issues, disputes or claims arising out of or in connection with it (whether contractual or non-contractual in nature) shall be governed by, and construed in accordance with, the laws of the State of Delaware.
IN WITNESS of the above the parties have signed this Agreement on the dates set out next to their signature.
SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES TEXAS, LLC:
Signature: /s/ Gerry Farrell
Date: February 13, 2021
SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A., INC:
Signature: /s/ Andy Fenny
Date: February 12, 2021
SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED:
Signature: /s/ Paul Found
Date: February 22, 2021
SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES DENMARK APS:
Signature: /s/ Lars Petersen
Date: February 24, 2021
SIGNED for and on behalf of VIGIL NEUROSCIENCE, INC.:
Signature: /s/ Ivana Magovcevic-Liebisch
Title: President & CEO
Date: February 11, 2021
Schedule 1 Charges
The Customer will pay to Fujifilm the Charges for the Fujifilm Services in accordance with the Scope of Work and clause 8 (the Fujifilm Services being the services to be performed by Fujifilm that are described in the relevant Scope of Work which are not Ancillary Services).
The Customer will also pay Charges to Fujifilm in consideration of the research and development and technical consultancy services in relation to the procurement, testing and management of Consumables; Subcontracted Work (including delivery of material to and from such subcontractors); Process-Specific Equipment (including installation and qualification thereof); Modifications; and Special Waste (the Ancillary Services) as calculated in accordance with this Schedule 1.
Charges for Consumables in Non-Manufacturing Stage and Manufacturing Stage
At the time set out in the Scope of Work, or in the course of the Program as mutually agreed in writing by the parties, the Customer shall pay to Fujifilm an amount in advance in consideration of the Ancillary Services relating to the purchase of Consumables intended to be used during the applicable Non-Manufacturing Stages and Manufacturing Stages. This will be an amount based upon an estimation of the sums required to purchase Consumables based upon Fujifilms historical data from previous manufactures at the applicable scale of production plus [***] of such sums (the Consumables Advance Payment).
On completion of each applicable Non-Manufacturing Stage or Manufacturing Stage, Fujifilm shall calculate the expenditure incurred in respect of Consumables procured for use during such Non-Manufacturing Stage or Manufacturing Stage and shall add a sum equivalent to [***] of all such expenditure on to such sum, the aggregate amount being referred to as Actual Production Expenditure.
If the Actual Production Expenditure is greater than the Consumables Advance Payment plus any other amounts paid under paragraph 1.4, Fujifilm shall issue a further invoice for the Ancillary Services in relation to the Consumables for a sum equivalent to the difference on a monthly basis with a [***] markup. If the Actual Production Expenditure is less than the Consumables Advance Payment, Fujifilm shall issue a credit note against the earlier invoice for a sum equivalent to the difference to be applied to the Charges for the following Stage upon Completion of reconciliation (if there is one), and if there is not a following Stage, Fujifilm shall promptly refund such amount.
Each month, Fujifilm may issue an invoice to the Customer in relation to the Ancillary Services regarding any Consumables used during or procured for use in any Stage during the previous month (or if longer, since the last invoice under this paragraph 1.4 was issued) in amounts which are not covered by the Consumables Advance Payment equivalent to the expenditure on such additional Consumables during the previous month plus an amount equal to [***] of such expenditure.
For the avoidance of doubt, Process-Specific Consumables paid for by Customer shall be used solely for the Program
Additional Charges in Respect of Subcontracted Work, Process-Specific Equipment, Modifications and Special Waste
Fujifilm shall invoice the Customer for the Ancillary Services relating to the Subcontracted Work, Process-Specific Equipment, Modifications and disposal of Special Waste as the case may be in the same amount as the expenditure which Fujifilm incurs in respect of such Ancillary Services plus a sum equivalent to [***] of such expenditure.
Fujifilm shall issue invoices for such Ancillary Services either at the time Fujifilm incurs expenditure in respect of the Subcontracted Work, Process-Specific Equipment, Modifications and/or disposal of Special Waste or as set out in the relevant SoW as the case may be.
Purchase of Process-Specific Consumables and Process-Specific Equipment by the Customer on completion of the relevant Stage or termination
the manufacturers consent and requirements (if applicable) and subject to the Customers warranty that it will purchase a direct license of any relevant firmware/software required to operate the Process-Specific Equipment;
and the payment of all relevant Charges,
the Customer shall have an option to purchase from Fujifilm such Process-Specific Equipment and/or Process-Specific Consumables purchased and paid for by Fujifilm under paragraphs 1 and 2 of this Schedule 1 as remain following completion of the relevant Stage for which such Process-Specific Equipment and/or Process-Specific Consumables were purchased for consideration of [***] payable, if the work is performed in the UK or USA respectively, at the time of such sale. Fujifilm shall, at Customers request and in accordance with Clause 7, deliver to Customer Process-Specific Equipment and/or Process-Specific Consumables previously paid for by Customer under paragraphs 1 and 2.
The option in paragraph 1.1 shall be exercised within [***] following completion of the relevant Stage under which such Process-Specific Equipment and/or Process-Specific Consumables were purchased or termination of this Agreement (whichever occurs first).
The Customer shall be responsible for any cost and expense associated with removal/delivery of such Process-Specific Equipment and/or Process-Specific Consumables and documenting such sale. Such Process-Specific Equipment and/or Process-Specific Consumables shall be delivered Ex Works the Facility (Incoterms 2010). Risk in and title to such Process-Specific Equipment and/or Process-Specific Consumables shall pass on delivery.
Fujifilm shall be free to use or destroy (at the Customers cost) any item(s) of Process-Specific Equipment or Process-Specific Consumables in respect of which the option referred to in this paragraph 3 is not exercised or for which their assigned expiry date has passed.
Product Samples, Cell Banks and other materials on completion or termination
Prior to completion of each Program, the Customer shall notify Fujifilm what (if any) samples and/or cell banks used during the Program the Customer wishes Fujifilm to deliver to the Customer and, subject to clause 10.3, delivery of those samples/cell banks shall take place in accordance with clause 7. If the Customer does not give any such notification to Fujifilm prior to completion of the Program, Fujifilm may destroy such samples and/or cell banks without further notice at the Customers cost.
Fujifilm shall be entitled, in a manner of its choosing and without further notice to the Customer, to dispose of any Product, samples, cell banks or other property of the Customer which remains in the possession of Fujifilm in excess of [***] following the effective date of termination.
5. Batch Cancellation Fees
The Batch Cancellation Fee shall be:
the applicable percentage of the Batch Fee (in each case as detailed in the SoW) set out in the table below, which will reflect the period of time between:
notice of cancellation of such Batch(es); and
the then current date for commencement of the relevant Stage;
less any sums already received under the SoW for the Fujifilm Services in relation to the cancelled Batch(es) that have not been performed at the time the Batch Cancellation Fee is calculated.
Percentage of Batch Fee payable:
Period prior to Commencement of Stage
Percentage of Batch Fee
Program Cancellation Fees
The Program Cancellation Fee shall be:
the applicable percentage of the total price of the remaining part of the Program (detailed in the SoW(s)) that is being cancelled set out in the table below, which will reflect the period of time between:
notice of cancellation of the Program; and
the then current date for commencement of the Manufacturing Stage(s)
less any sums already received under the SoW(s) for the Fujifilm Services in relation to the cancelled element of the Program that have not been performed at the time the program Cancellation Fee is calculated.
Percentage of total price of the Program payable:
Period prior to Commencement of the Manufacturing Stage(s)
Percentage of remaining total Program price
[***]For the avoidance of doubt the Customer will not be expected to pay both Batch Cancellation Fees and Program Cancellation Fees and the Program Cancellation Fee for Non-Manufacturing Program are the fees described in clause 14.3.1.
Schedule 2 Addresses for Notice
Contact: Chief Operating Officer
Address: Fujifilm Diosynth Biotechnologies, Belasis Avenue, Billingham, TS23 1LH, England
Nominated email address: [***]
Contact: Legal Counsel
Address: Fujifilm Diosynth Biotechnologies, Belasis Avenue, Billingham, TS23 1LH, England
Nominated email address: [***]
Contact: Chief Operating Officer
Address: FUJIFILM Diosynth Biotechnologies Texas, LLC, 3939 Biomedical Way, College Station, TX 77845
Nominated email address: [***]
Contact: Legal Department
Address: FUJIFILM Holdings America Corporation, 200 Summit Lake Drive, Valhalla, NY 10595.
Nominated email address: [***]
Contact: Chief Operating Officer
Address: FUJIFILM Diosynth Biotechnologies U.S.A., Inc., 101 J. Morris Commons Lane, Morrisville, NC 27560
Nominated email address: [***]
Contact: Legal Department
Address: FUJIFILM Holdings America Corporation, 200 Summit Lake Drive, Valhalla, NY 10595.
Nominated email address: [***]
Address: Biotek Alle 1, 3400 Hillerød, Denmark
Nominated email address: [***]
Contact: Legal Counsel
Address: FUJIFILM Diosynth Biotechnologies, Belasis Avenue, Billingham, TS23 1LH, England
Nominated email address: [***]
Customer: Vigil Neuroscience, Inc.
Address: 300 Technology Square, 8th floor, Cambridge MA 02139
Nominated email address: [***]
Address: 300 Technology Square, 8th floor, Cambridge MA 02139
Nominated email address: [***]