1. General: Entire Agreement
These Cellesce Terms and Conditions for Supply of Products and Related Services (“Terms” or “Agreement”) shall govern the sale of organoids (“Products”) and associated services by Cellesce Limited, a company registered in England and Wales under number 08484947 (“Seller”) for the party purchasing such products (“Buyer”). Seller’s offer to sell Products to Buyer is expressly limited to Buyer’s acceptance of these Terms.
Additional or different terms or conditions proposed by Buyer (including any additional or different terms provided in a purchase order) shall be void and of no effect unless specifically accepted in writing by Seller. These Terms and, if Buyer purchases custom Products, the respective Proposal (as defined Sec. 2 below) shall be the exclusive agreement between the parties for the Products and associated services purchased by Buyer from Seller. Any prior or contemporaneous understandings, agreements, and representations, oral or written, are superseded by these Terms. No modification to these Terms shall be valid unless in writing and signed by both parties. In the event of any conflicts between these Terms and the Proposal, the terms and conditions of the Terms shall prevail unless the fully executed Proposal specifically describes the provision of these Terms to be modified.
2. Technical Requirements
All standard and off-the-shelf Products shall be provided in accordance with the specifications/technical requirements set forth in the Certificate of Analysis accompanying such Products.
If Buyer wishes to purchase custom Products from Seller, Seller and Buyer shall sign a proposal or statement or work (each, a “Proposal”) which shall specify, among other things, the custom Products to be provided by Seller to Buyer, specifications/ technical requirements for such Products, the description of services to be provided in connection with such Products, such as development, upscaling and manufacturing services and, if applicable, milestones and key assumptions for the project.
The Products covered by this Agreement shall be sold and invoiced at the prices listed on Seller’s quotation (for standard Products) and the Proposal (for custom Products). Prices do not include sales, excise, use or other taxes now in effect or hereafter levied by reason of this transaction. Payment terms are net thirty (30) days from date of invoice.
Unless stated otherwise by Seller, all shipments will be F.C.A. (Free Carrier) (as defined in Incoterms 2010) Seller’s shipping facility, if destination of delivery is outside the United States, and F.O.B. (Free on Board) (as defined in U.C.C. Section 2-319) Seller’s shipping facility, if destination of delivery is within the United States. Seller may make delivery in installments and may render a separate invoice for each installment.
5. Use of Products
5.1. ALL PRODUCTS PROVIDED BY SELLER TO BUYER ARE FOR SINGLE USE ONLY IN RESEARCH ASSAYS OR EXPERIMENTS AND (i) ARE NOT TO BE PASSAGED FOR FURTHER REPEATED USE OR FOR OTHER ORGANOID EXPANSION PURPOSES, AND (ii) ARE NOT TO BE USED FOR ANY COMMERCIAL PURPOSES INCLUDING THE PROVISION OF SERVICES.
5.2. All Products provided by Seller to Buyer are for Buyer’s use only. Buyer shall not: (i) make Products or any portion of them, in any way, shape or form, including as a component of another product, available for the purpose of further resale, (ii) alter, remove the product label and Seller’s mark of origin without the express written permission of Seller, or (iii) sequence or analyze any of the Products in a way that could potentially identify the original donor of the tissue from which they are derived.
5.3. The foregoing restrictions set forth in Sec. 5.1 and 5.2 do not apply to organoids provided by Buyer to Seller (“Buyer provided organoids”) for scale-up and production by Seller on Buyer’s behalf and supply by Seller to Buyer under this Agreement.
A. Product Warranty. Seller warrants that the Product purchased from Seller by Buyer shall meet the technical requirements set forth in the Certificate of Analysis accompanying the Product for a period of the shelf life and expiry date set forth in such Certificate of Analysis, whichever is earlier, or, if no shelf life or expiry date is listed on the Certificate of Analysis, for three (3) months from the Product delivery date, provided that the Product has been used in accordance with the documentation accompanying the Product, including the analysis techniques and methods set forth in the Certificate of Analysis for the Product. Buyer shall provide prompt written notice of non-conforming Products to Seller and give Seller a reasonable opportunity to examine such Products. On Seller’s request and at Seller’s option, Buyer shall return such non-confirming Products to Seller for the examination or make such Products available for Seller’s examination at Buyer’s place of business. Seller shall reimburse Buyer for the cost of return shipment of the defective Products to Seller.
B. Warranty Exclusion. The warranties provided above and the remedies provided below will not apply to any Product if: (i) Seller determines that a problem is caused by accident, abuse, misuse, failure to follow Seller’s written instructions with respect to the Product storage, negligence, misapplication, fire, earthquake, flood, other force majeure event, or unauthorized alteration or modification of the Product; (ii) a problem arises from or is based on Seller’s compliance with Buyer’s specifications, or (iii) Buyer makes any further use of the Products after giving notice to Seller that such Products are non-comforting.
C. Remedy. For any breach of the warranties provided in this statement, Seller will, at its own expense and option, and as its sole obligation, and as Buyer’s exclusive remedy, replace any defective Product (or the non-conforming part thereof), if Buyer notifies Seller during the applicable warranty period and Seller determines that the Product is defective and is covered by the warranty. The warranty period for the replaced Product shall be the period of the shelf life and expiry date set forth in the Certificate of Analysis accompanying such Product, whichever is earlier, or, if no shelf life or expiry date is listed on the Certificate of Analysis, for three (3) months from such replacement Product delivery date. If Seller so requests, Buyer shall, at Seller’s expense, return the non-confirming Products to Seller. Any Products, or part thereof, replaced pursuant to the warranty, shall belong to Seller.
D. Warranty Disclaimer. THE FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, EITHER EXPRESS, IMPLIED, OR STATUTORY, REGARDING THE PRODUCTS, INCLUDING ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT OF THIRD PARTY RIGHTS.
E. Additional Disclaimer. Any sample or model of the Product(s) used in connection with this Agreement is for illustrative purposes only, is not part of the basis of this Agreement, and is not to be construed as a warranty that the Products will conform to the sample or model.
7. Limitation Of Liability
IN NO EVENT WILL EITHER PARTY BE RESPONSIBLE OR LIABLE FOR ANY THIRD PARTY FOR ANY LOST PROFITS, OR INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR CONTINGENT DAMAGES ARISING FROM OR RELATING TO THIS CONTRACT, EVEN IF IT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. EACH PARTY’S TOTAL CUMULATIVE LIABILITY IN CONNECTION WITH THIS AGREEMENT, INCLUDING FOR ANY LIABILITY ON ACCOUNT OF A CLAIMED DEFECT IN ANY PRODUCT DELIVERED HEREUNDER, WHETHER IN CONTRACT OR TORT OR OTHERWISE, SHALL IN NO EVENT EXCEED THE PURCHASE PRICE OF THE PRODUCT PAID BY BUYER ON WHICH THE CLAIM IS BASED.
8. Intellectual Property
A. Intellectual property shall include without limitation all rights to and any interests in any patent, design, trade mark, copyright, know-how, trade secret and any other proprietary right or form of intellectual property (whether protectable by registration or not), Buyer list, specification, formula, device, drawing, design, system, process, logo or mark (“Intellectual Property”).
B. All Intellectual Property in the Products and any materials prepared or supplied by Seller in connection with the provision of the Products shall remain the property of Seller.
C. THE PRODUCTS ARE PROVIDED FOR RESEARCH USE ONLY NOT FOR ANY THERAPEUTIC OR DIAGNOSTIC USE IN HUMANS OR ANIMALS. SELLER RECOMMENDS BUYER TO ASSESS THE INTELLECTUAL PROPERTY LANDSCAPE AND THE REQUIREMENT FOR ANY LICENSES FROM SELLER OR OTHER THIRD PARTIES PRIOR TO ENGAGING IN ANY WORK USING THE PRODUCTS. THIS MAY INCLUDE LICENSES FOR HUB ORGANOID TECHNOLOGY FROM THE STICHTING HUBRECHT ORGANOID TECHNOLOGY (https://huborganoids.nl/).
D. Buyer provided organoids. Buyer represents and warrants that it has the right to provide Buyer provided organoids to Seller for use by the Seller for the purpose of fulfillment of Seller’s obligations under this Agreement. Buyer retains ownership in Buyer provided organoids, which Buyer has either generated or accessed through third parties. No onward culture of Buyer provided organoids following completion of performance of Seller’s obligations under this Agreement will be performed by Seller (unless otherwise specified by Buyer). All Buyer provided organoids will be destroyed and disposed of by Seller at the end of manufacture, scale up and supply services following the local guidelines for biohazardous waste, unless otherwise agreed upon by the parties.
E. For manufacture, scale up and supply services of HUB Organoids that Buyer has accessed and licensed from HUB Organoid™ biobank, prior to transferring such Buyer provided organoids to Seller, Buyer shall complete the Material Transfer Form Letter (MTFL) which will be provided by Seller to Buyer upon request. Buyer will send the completed MTFL to the Regulatory Affairs Dept at Stichting Hubrecht Organoid Technology ([email protected]) and to Seller to confirm transfer and shipment of HUB Organoids to Seller.
9. Confidential Information.
“Confidential Information” means the non-public information about Byer’s business, including any Buyer provided organoids, that is disclosed by Buyer to Seller under this Agreement. Except with written consent of Buyer, Seller shall not disclose Confidential Information to any third parties and shall use Confidential Information solely for the purposes of performing its obligations under this Agreement. Seller shall protect Confidential Information against unauthorized use or disclosure using no less than reasonable care. Upon completion of performance of Seller’s obligations under this Agreement, Seller shall destroy all Confidential Information in its possession or control, provided that Seller may retain one copy of Confidential Information in its confidential files for ascertaining any continuing obligations, and subject to any copies remaining on Recipient’s standard computer back up devices. The obligations set forth in this Section 9 shall survive termination or expiration of these Terms.
10. Independent Contractor
The parties are acting hereunder as independent contractors and not as partners, agents, fiduciaries, or joint venturers. Neither party has the power or authority represent, act for, bind, or otherwise create or assume any obligation on behalf of the other party.
11. Force Majeure
Any delay in the performance of any duties (except for payment of fee owed) by either party will not be considered a breach if such delay is caused by a labor dispute, shortage of materials, fire, earthquake, flood, pandemic or other event beyond the control of such party, provided that such party uses reasonable efforts to notify the other party of the circumstances causing the delay and to resume performance as soon as possible.
Any notice under this Agreement shall be considered to have been given if sent by registered or certified mail, reputable courier service, or personal delivery to the address of the principal office of such party as follows (or to such other address as either Party may specify by notice given to the other Party):
To Buyer: at the Buyer’s address set forth on the Buyer’s purchase order accepted by Seller.
With a copy to: the Buyer’s address set forth in the Proposal (if any), if different from above.
To Seller: Cellesce Ltd
CF14 4UJ, United Kingdom
With a copy to: Cellesce Ltd c/o Molecular Devices
Attn: Legal Department
3860 N. First Street,
San Jose, CA 95134
This Agreement is made, governed by, and shall be construed in accordance with the laws of England and Wales, without regard to conflicts of law principles that would result in application of laws of any other jurisdiction. The United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement. All waivers must be in writing. A party’s failure to exercise any of its rights under this Agreement shall not constitute a waiver or forfeiture of any such rights nor of any other rights. If any provision of this Agreement is unenforceable or invalid pursuant to any applicable law, such unenforceability or invalidity will not render this Agreement unenforceable or invalid as a whole, and such unenforceable or invalid provision will be changed and interpreted so as to best accomplish the objectives of such provision within the limits of applicable law or applicable court decisions. These Terms and, if Buyer purchases custom Products, the respective Proposal represent the entire agreement between the parties as to the matters set forth herein and integrates all prior discussions and understanding between the parties. Buyer’s rights hereunder may not be assigned to any third party by Buyer except with the prior written approval of Seller. Seller may assign its rights and obligations under this Agreement to its affiliates (an “affiliate” means a business entity that controls, is controlled by or under common control with Seller) provided that Seller shall remain responsible for performance of such affiliates under this Agreement.