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Organoid terms and conditions



“Cancer Research UK” means Cancer Research UK a company registered under number 4325234 and registered charity number 1089464 and with its registered office at 2 Redman Place, London, E20 1JQ, UK.

“” means Cancer Research Technology Limited a company registered in England under number 1626039 and with its registered office at 2 Redman Place, London, E20 1JQ, UK, and its successors and assigns.

“Commercial Use” means the sale, license, lease, export, transfer or other distribution of the F- PDO to a person or entity not party to this contract for financial gain or other commercial purposes and/or the use of the F-PDO: (a) to provide a service to a person or entity not party to these Terms and Conditions for financial gain; (b) to produce or manufacture products for general sale or products for use in the manufacture of products ultimately intended for general sale. In addition, Commercial Use means the sale, license, lease, export, transfer or other distribution of any research result(s) developed in Investigator’s laboratory by the use of the F-PDO for financial gain or other commercial purposes. Commercial Use specifically does not include Industry Sponsored Academic Research.

“Effective Date” means the date the Purchaser receives the F-PDO.

“F-PDO” means any organoids acquired from FMU as documented in the Sales Order, any Progeny, Unmodified Derivatives, Modifications and Unmodified Derivatives within Modifications, either individually or jointly, to be supplied by to the Purchaser under this contract.

“Industry Sponsored Academic Research” means research sponsored by a for-profit organization carried out at a non-profit organization and by the non-profit organization’s employees.

“Investigator” means the Purchaser’s principal scientist or researcher using the F-PDO.

“Sales Order” means an order submitted for the F-PDO in a form and format as determined by from time to time.

“CRO” means a third party entity performing research under contract for the Purchaser.

“License Term” means an initial period of five (5) years starting from the Effective Date and ending on the Termination Date.

“Modification(s)” means organoids created by the Purchaser with modifications of the F-PDO provided by

“Progeny” means any descendant from the F-PDO provided by and derived directly from the Modifications.

“Purchaser(s)” means the organization (which shall include any organisation or a person who purchases on behalf of) purchasing and receiving the F-PDO pursuant to this contract.

“Unmodified Derivative(s)” mean substances created or extracted by the Purchaser that constitute an unmodified functional sub-unit or product not changed in form or character and expressed by the F-PDO provided by

“Research Purposes” means experimental research purposes only and excludes any (i) research or testing involving human subjects and (ii) therapeutic or diagnostic purposes.

“Source” means Fukushima Medical University.

“Source Intellectual Property Rights” means the F-PDO name and the registered trade mark number of US 79244654 / WO 1432391 / JP 2018-004818.

“SPI” means Summit Pharmaceuticals Incorporation.

“Termination Date” means five (5) years from the Effective Date.


2.1 Sales Orders for F-PDO raised by the Purchaser are subject to written acceptance by

2.2 Acceptance of F-PDO by the Purchaser shall be deemed conclusive evidence of the Purchaser’s acceptance of the conditions of sale set out in this contract.

2.3 Unless other terms and conditions are expressly accepted by by means of a specific amendment hereto signed by, all orders and contracts for supply of F-PDO will be on these terms and conditions to the exclusion of any other terms and conditions whether or not endorsed upon or referred to in any purchase order or otherwise.

2.4 The Uniform Laws on International Sales Act 1967 shall not apply to this contract.

2.5 Any quotation is valid for a period of thirty (30) days only from its date provided that has not previously withdrawn it.


3.1, by written notice, will require payment for F-PDO and if required shipping costs, in advance of delivery. The payment will be made by the Purchaser in full without any deductions and before any shipment of F-PDO is made. All payments shall be made in US Dollars. Payment shall be made by credit/debit card payment link service via

3.2 Only in instances where has agreed an account with the Purchaser, will the price become payable on delivery.

3.3 If the Purchaser fails to pay in full then the order will be cancelled, and the delivery of F-PDO will be suspended.


4.1 F-PDO will be delivered Ex Works by’s UK production and storage premises or Ex Works by SPI’s Japanese production and storage premises, and risk in and to the F-PDO will pass to the Purchaser on delivery.

4.2 The Purchaser shall make all arrangements necessary to take delivery of the F-PDO whenever they are tendered for delivery by

4.3 On request and by’s written acceptance of such request, shall arrange transport of F-PDO to the Purchaser but all costs and risk associated therewith shall be borne by the Purchaser.

4.4 will use its reasonable endeavours to meet any agreed date for delivery of the F-PDO, but in no circumstances shall have any liability for loss or damage of any kind whatsoever caused directly or indirectly by any delay in delivery of the F-PDO nor unless such delay exceeds sixty (60) days will any delay entitle Purchaser to cancel or terminate this contract.

4.5 If the Purchaser fails to accept delivery of F-PDO on the delivery date stipulated by or within 3 days of notification that F-PDO is ready for dispatch, reserves the right to request that the Purchaser shall pay reasonable storage charges or demurrage as appropriate in the circumstances until the F-PDO are either dispatched to the Purchaser or disposed of elsewhere.


5.1 Subject to the terms of this contract, the Investigator may make and use the F-PDO for non-exclusive Research Purposes in the Investigator’s laboratory only. The Purchaser shall procure that all persons to whom the Purchaser makes the F-PDO available are made aware of and comply with the provisions under this contract. For clarity, the Investigator may establish tumor xenograft models with transplantation of the F-PDO to animals. The F-PDO is not intended for use in humans. The Purchaser agrees that the F-PDO designated as biosafety level 2 constitute known pathogens and that other F-PDO not designated this way may be pathogenic under certain conditions. The Purchaser assumes all risk and responsibility in connection with the receipt, handling, storage, disposal, transfer and the Purchaser’s use of the F- PDO including without limitation taking all appropriate safety and handling precautions to minimize health or environmental risk. The Purchaser agrees that any activity undertaken with the F-PDO will be conducted in compliance with all applicable guidelines, laws and regulations including Personal Information Protection Law, and that the Purchaser will obtain all permits, licenses or other approvals required by any governmental authority in connection with the Purchaser’s receipt, handling, storage, disposal, transfer and use of the F-PDO.

5.2 F-PDO shall be used solely by the Purchaser and those within the Investigator’s immediate research group only who are under the Purchaser’s direct supervision. Purchaser and/or Investigator shall not make F-PDO available to any persons or organisations outside of the Investigator’s immediate research group at the time of purchase and shall ensure that F-PDO is not taken or sent to any location other than the Investigator’s laboratory.

5.3 The Purchaser shall ensure the proper and safe handling, storage and use of the F-PDO in accordance with all applicable laws and regulations.

5.4 The Purchaser and/or Investigator shall not distribute, sell, lend or otherwise transfer, to a person other than the Investigator, or entity not party to thiscontract, the F-PDO, as defined above, for any reason, without’s prior written consent.

5.5 Any Commercial Use of the F-PDO is strictly prohibited without’s prior written consent. The Purchaser acknowledges and agrees that the Purchaser’s use of certain F-PDO may require a license from a person or entity not party to this contract, or be subject to restrictions that may be imposed by a person or entity not party to this contract (“Third Party Terms”). To the extent of’s knowledge of the existence of any such applicable rights or restrictions, will take reasonable steps to identify the same, and to the extent they are in the possession of, shall make information regarding such Third Party Terms reasonably available for review by the Purchaser upon request. The Purchaser expressly acknowledges that if there is a conflict between this contract and the Third Party Terms, the Third Party Terms shall govern. Use of the F-PDO may be subject to the intellectual property rights of a person or entity not party to this contract. makes no representation or warranty that the use of the F-PDO will not infringe any patent or other proprietary right and regarding the existence or the validity of such rights. The Purchaser shall have the sole responsibility for obtaining any intellectual property licenses necessitated by its possession and use of the F-PDO.

5.6 The use permitted under this contract for Industry Sponsored Academic Research extends only to academic research carried out at the non-profit organization by non-profit organization’s employees and only for the extent of the Project. The non-profit organization using the F-PDO in connection with Industry Sponsored Academic Research agrees to notify the industrial sponsor that any use of the F-PDO by the industry sponsor will require a separate license from and that is under no obligation hereunder to license any F-PDO to any such industry sponsor.

5.7 The F-PDO may not be transferred by the Purchaser to any third parties. The Purchaser agrees that any investigator other than the Investigator utilizing the F-PDO will be required to obtain a separate license from

5.8 Notwithstanding the above, the Purchaser may transfer the F-PDO to CRO only for the purpose of outsourcing the Investigator’s research under contract basis, such as an establishment of tumor xenograft model and a non-clinical drug efficacy testing for anti-tumor agents, and any such CRO must agree to be bound by the terms and conditions of this contract as if a Purchaser hereunder and to not further transfer such F-PDO. If the Purchaser transfers the F-PDO to CRO for the purpose aforementioned, the Purchaser shall give a prior written notice of its intention and the name of such CRO. Upon completion of any contracted research, the Purchaser shall require the CRO to either destroy such F-PDO or return it to the Investigator.

5.9 is providing the Purchaser with the F-PDO pursuant to an agreement by and between and SPI. The Source and SPI are an express third party beneficiary of this contract.


6.1 This contract shall take effect from the Effective Date and shall continue until the Termination Date, unless earlier terminated pursuant to the provisions of this Clause 6.

6.2 Either party may terminate this contract forthwith by notice in writing if the other:

a. is in breach of this contract and, in the case of a breach capable of remedy, has failed to remedy the breach within fourteen (14) days of the receipt of a request in writing from the party not in breach to remedy the breach; or

b. has a receiver, manager, administrator or administrative receiver appointed of its assets or income or part thereof or has passed a resolution for its winding-up or has a petition presented to any court for its winding-up or for an administration order.

6.3 At the end of the License Term the Purchaser shall stop to use the F-PDO and shall give a written confirmation by authorized persons the destruction of remaining the F-PDO in the Investigator’s laboratory. Such written confirmation shall be sent by e-mail to [email protected] no later than one (1) month after the expiration of this contract. The Certificate of Destruction is available upon request.


7.1 warrants that (a) cells included in the F-PDO provided by shall be viable upon initiation of culture for a period of thirty (30) days after receipt of such F-PDO by the Purchaser and (b) the F- PDO provided by shall meet the specifications on the applicable Product Data Sheet (PDS) and/or certificate of analysis for a period of one hundred and twenty (120) days after receipt of such F-PDO by the Purchaser (such thirty (30) day period, or such one hundred and twenty (120) day period, referred to herein as the “Warranty Period”). The Purchaser’s exclusive remedy, and’s sole liability, for breach of the warranties set forth in this paragraph is for to, at’s sole option, either (i) to grant a fair and reasonable price reduction for such F-PDO (exclusive of shipping and handling charges), or (ii) replace the F-PDO. The warranties set forth in this paragraph apply only if the Purchaser handles and stores the F-PDO as described in the applicable Product Data Sheet (PDS). To obtain the exclusive remedy, the Purchaser must report the lack of viability or non-conformation to specifications to within the applicable Warranty Period. An expiration date of the F-PDO is the last day of the License Term, which states the expected remaining useful life, but does not constitute a warranty or extend any applicable Warranty Period. Except as expressly provided above, the F-PDO and any technical information and assistance provided by are provided as-is, without warranties of any kind, express or implied, including but not limited to any implied warranties of merchantability, fitness for a particular purpose, typicality, safety, accuracy and/or non-infringement.


8.1 The Purchaser is solely responsible for compliance with all foreign and domestic, federal, state and local statutes, ordinances, governmental regulations and guidelines and any other regulations or guidelines pertaining to research that may be to use of the F-PDO. If there is any conflict between the terms of this contract and any applicable law or regulation with respect to the F-PDO that are supplied hereunder by, then the terms of the applicable law or regulation shall govern.


9.1 The Purchaser shall, at all times during the term of this contract and thereafter, indemnify, defend and hold harmless, the Source, SPI and their directors, officers, employees, agents, investigators and affiliates from and against all claims, proceedings, demands and liabilities of any kind whatsoever, including legal expenses and reasonable attorneys’ fees, resulting from the Purchaser’s use, handling, storage, or disposition of the F-PDO and other activities relating to the F-PDO, provided that the Purchaser’s liability shall be limited to the extent that any such claim arises out of’s or Source’s or SPI’s gross negligence or willful misconduct.

9.2 In no event will, the Source and SPI be liable for any use of the F-PDO by the Investigator, or laboratory personnel under the Investigator’s control, or by the Purchaser, or for any loss, claim, damage or liability of any kind or nature, that may arise from or in connection with the contract or with the use, handling, storage, or disposition of the F-PDO. In addition, in no event shall the Source and SPI be liable for any indirect, special, incidental or consequential damages of any kind in connection with or arising out of the contract or F-PDO (whether in contract, tort, negligence, strict liability, statute or otherwise) even if, or the Source and SPI has been advised of the possibility of such damages. In no event shall’s cumulative liability to the Purchaser exceed the fees paid by Purchaser under this contract.


10.1 As between the parties, the Source shall retain ownership of all right, title and interest in the F-PDO. The Purchaser retains ownership of those substances created through the use of the F-PDO, but which do not contain the F-PDO. If Purchaser solely develops, conceives or reduces to practice any inventions, discoveries, improvements, developments, or other technology in connection with the use of the F-PDO (collectively “Inventions”), all such intellectual property rights in and to the Inventions shall be solely owned by the Purchaser. Notwithstanding the foregoing, Purchaser acknowledges and agrees that the F-PDO is subject to the restrictions noted in the “Scope of Use” section above. The Purchaser is not restricted from any publication of research results using the F- PDO, provided that the Purchaser agrees to acknowledge the Source of the F-PDO (quoting the catalogue reference number) in all research, academic or scholarly publications and in patent applications that reference the F-PDO. The Purchaser explicitly acknowledges that the Source retains all right, title and interest in the Source Intellectual Property Rights the Source specific designations of the F-PDO sold The Purchaser expressly agrees not to use the Source Intellectual Property Rights or the Source’s specific designations of the F-PDO sold by in any way without’s prior written consent.

10.2 Save for the limited right for the Purchaser to use F-PDO for Research Purposes only, no licence is granted or implied under any intellectual property or other rights of, the Source or SPI. The Purchaser acknowledges and agrees that it has no right, title or interest whatsoever in F-PDO.


11.1 This contract shall be governed by and construed in accordance with English law. Each party agrees that the courts of the main place of business of the defendant shall have exclusive jurisdiction to settle any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with this contact or its subject matter or formation.

11.2 shall not be deemed to be in breach of this contract or otherwise liable to the Purchaser for any failure or delay in performing its obligations under this contract due to any cause beyond its reasonable control, which expression shall include, without limitation, governmental action, labour disputes involving the workforce or part thereof of or CR-UK and Act of God.

11.3 The Purchaser may not assign or otherwise transfer this contract or any rights or obligations under this contract, whether by operation of law or otherwise. Any such attempted assignment or transfer will be void and of no force or effect. This contract, including all documents incorporated herein by reference, constitutes the entire agreement between and the Purchaser with respect to the F-PDO and supersedes all previous agreements or representations (whether written or oral) between and the Purchaser relating to the same subject matter. This contract may not be modified, waived or terminated except in writing and signed by the parties hereto. No term or provision contained herein shall be deemed waived and no breach excused unless such waiver or consent shall be in writing and signed by the parties. If any provision of this contract is for any reason found to be unenforceable, the remainder of this contract will continue in full force and effect. None of the provisions of this contract are intended to create, nor shall be deemed or construed to create, any relationship between or the Purchaser other than that of independent entities contracting with each other hereunder solely for the purpose of effecting the provisions of this contract.

11.4 Nothing contained in this contract shall be construed as establishing or implying any partnership or joint venture between the Purchaser and and/or CR-UK and/or SPI and/or the Source.

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