Newcells Biotech Ltd Terms and conditions for Sales of products & Service (Terms)
1. Definitions
In this Agreement, unless the context otherwise requires, the following words and expressions shall have the following meanings:
1.1. “Affiliate” means any entity controlling, controlled by, or in common control with a Party. For the purposes of this definition, “Control” shall mean ownership or control, directly or indirectly, of more than fifty percent (50%) of the common voting stock or ordinary shares in the entity or the right to appoint fifty percent (50%) or more of the directors of that entity.
1.2. “Anti-Corruption Laws” means any anti-bribery and anti-corruption laws, rules, regulations applicable to either Party, including the UK Bribery Act 2010 and the OECD Convention Against the Bribery of Foreign Government Officials in International Business Transactions, together with any applicable implementing legislation, including any applicable local law addressing bribery or corruption.
1.3. “Background IP” means all pre-existing intellectual property belonging to or licensed to a Party or other intellectual property created outside the scope of the Services.
1.4. “Biological Material” means cell lines & cell models including but not limited to induced pluripotent stem cell (iPSC) clones, progeny or differentiated cells along with spheroids, organoids and co-cultures derived for iPSCs, and/or primary cultured cells or similar.
1.5. “Claim” means any third-party claims, demands, assessments, actions, suits, proceedings, settlements or investigations.
1.6. “Confidential Information” means any and all commercial or technical information or materials and all derivatives thereof, in any and all forms, howsoever disclosed or obtained including business plans, financial information, client lists and requirements, techniques, designs, methods, processes and procedures which (I) is identified by a suitable legend or other marking as being confidential (or similar designation) in a prominent position or (ii) is described as being confidential at the time of disclosure or (iii) the disclosing Party regards or should reasonably be expected to regard as proprietary and confidential given the nature of the information and which is the subject of efforts that are reasonable under the circumstances to maintain its confidentiality.
1.7. “Deliverables” means as applicable to the services, results, data, final product, biological material or any other deliverable specified in the Scope of Work.
1.8. “Force Majeure Event” means circumstances or causes beyond the reasonable control of a Party, including war, threat of war or warlike conditions, blockade, embargo, fire, explosion, lightning, storm, drought, flood, earthquake or other natural disaster, pandemic or epidemic, power failure, shortage of labor or supplies, supply chain issues, strikes, lock outs, acts of terrorism, riot, civil unrest, insurrection, acts of government or other international bodies, political subdivision and any other events which by their nature could not have been foreseen by the Parties, or, if could have been foreseen were unavoidable by a reasonable prudent business.
1.9. “Donor” means a human individual, living or deceased, from whom a tissue sample (including blood sample) was obtained for use in provision of the Services.
1.10. “HBS” means Human Biological Sample
1.11. “IEC/IRB” means an independent ethics committee or institutional review board.
1.12. “Informed Consent” means an IEC/IRB approved informed consent form signed by the Donor authorizing the Use of their tissue.
1.13. “Invention” means any patentable invention or other registerable intellectual property rights discovered, conceived or made by Newcells or its Affiliates specifically as a part of the Services for the Sponsor and directly relating to the Test Materials.
1.14. “Materials” means the materials provided to Recipient by or on behalf of Provider under the foregoing sentence and any and all of the following generated by Recipient: subunits, progeny, modifications, analogs and unmodified derivatives of such materials and products expressed by such materials or by any of the foregoing.
1.15. “Loss” means any loss, cost, damage or expense (including reasonable legal expenses).
1.16. “Products” means each item, biological material, consumables, including any Newcells Material, Instrument, Software and/or Consumable, listed in the applicable written sales quotation issued by Newcells or, in the event a Quotation is not issued, listed in Newcells’s then-current price list applicable to the Sponsor’s jurisdiction, and identified in Sponsor’s purchase order.
1.17. “Quality Agreement” means an agreement between Newcells and the Sponsor detailing technical and regulatory matters associated with the provision of the Services.
1.18. “Results” mean materials, data, documents and information produced or developed by Newcells exclusively in the course of the Services and directly related to the Biological Material.
1.19. “Scope of Work” means the written document containing details of the Services to be provided, and any additional terms and conditions applicable to the Services.
1.20. “Services” means the services provided by Newcells to the Sponsor as more particularly described in the Scope of Work.
1.21. “Study Manager” means a study director, responsible scientist or other responsible person as appropriate to the Services and as defined in the Study Plan who shall be responsible for the Services.
1.22. “Study Plan” means a protocol or an equivalent document to be provided by the Sponsor or prepared by Newcells under the Sponsor’s direction in relation to the Services.
1.23. “Subcontractor” means a third party contracted by Newcells for Services within the scope of this Agreement or a Scope of Work.
1.24. “System Data” means control data from laboratory tests or transactional, volume and performance data related to the Services, which does not contain any Sponsor Confidential Information.
1.25. “Use” (in the context of Section 16) means collection, storage (including retention period) transfer (including import and export), use and return or disposal of HBS including by commercial organizations.
1.26. “Vendor” means third-party service providers other than a Subcontractor (a) for which Newcells may hold the contract with such service provider on behalf of the Sponsor in connection with Services under a Scope of Work or (ii) third party service providers that the Sponsor requires Newcells to use.
In this Agreement, unless the context otherwise requires:
1.26.1. Schedule and Section headings are inserted for convenience only and do not affect the construction or interpretation of this Agreement.
1.26.2. a particular law or statutory provision is a reference to it as it is in force for the time being taking account of any amendment, extension, or re-enactment and includes any subordinate legislation for the time being in force made under it.
1.26.3. writing or written includes faxes and e-mail.
1.26.4. a person includes a corporate or unincorporated body.
1.26.5. any gender includes all genders.
1.26.6. including, include, in particular or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms; and
1.26.7. words in the singular include the plural and vice versa.
1.26.8. If this Agreement is translated, the English language text shall prevail.
1.26.9. In the event of any inconsistency, the terms of the Study Plan or Quality Agreement shall prevail with respect to the scientific, technical and regulatory guidelines used in the conduct of the Services. If any direct conflict exists between the provisions of this Agreement and the Scope of Work, the provisions of this Agreement will prevail unless a provision in the Scope of Work expressly states otherwise, whereby such provision shall prevail in respect to the Scope of Work only.
2. Form of Contract
2.1. These Terms and Conditions of sale along with any Quotation(s) issued by Newcells, or any authorized subsidiary identified on the Quotation(s) and any applicable licenses, notices, terms, conditions or use restrictions referred to in Section 3 below, together with any label licenses, click-through licenses, conditions of use, or addenda to any of the foregoing provided by Newcells, any other terms and conditions expressly agreed to in writing by an authorized Newcells representative expressly referencing these Terms shall constitute the complete, exclusive and entire agreement between Newcells and the Sponsor with respect to purchase and/or license of the Deliverables from Newcells. Newcells’s offer to sell products and provide services is expressly limited to the Terms which shall supersede and take precedence over all other understandings or agreements written or oral, and any of Sponsor’s additional or different terms and conditions. Sponsor’s submission of a purchase order or other instrument for or regarding the purchase of Product(s) or Services from Newcells, whether or not in response to a Newcells Quotation or any other Newcells documents that include or incorporate these Terms, shall be deemed an acceptance of and agreement to the Terms to the exclusion of any other terms or conditions contained in and/or referenced by such purchase order or other instrument (except the name and identity of the Product(s) purchased, quantity, bill to and ship to address, and, if accurate, price), which are hereby deemed to be material alterations, and notice of objection to which is hereby given, notwithstanding anything to the contrary contained within such purchase order or other instrument or elsewhere. Except as otherwise provided in these Terms, in the event of an inconsistency between these Terms and the terms appearing on Newcells’s Quotation or other agreement signed by an authorized representative of Newcells, the terms appearing on Newcells’s Quotation or such other agreement shall supersede and take precedence over the inconsistent provision(s) of these Terms, and all other provisions of these Terms shall remain in full force and effect.
2.2. The terms and conditions of this Agreement shall apply to the Product & Services detailed as per the Scope of Work & Quotation(s) to the exclusion of any other terms that the Parties seek to impose or incorporate or which are implied by trade, custom, practice or course of dealing.
2.3. Upon receipt of the Sponsor’s request for Product and/or Services, Newcells shall provide a written Quotation pursuant to and referencing this Agreement. Upon signature by both Parties, a binding contract shall be formed, and this document shall serve as the terms and conditions for the purposes of this Agreement.
2.4. Each Agreement along with Scope of Work and/or Quotation(s):
2.4.1. shall be entered into by Newcells and the Sponsor.
2.4.2. forms a separate contract between the Parties.
2.4.3. shall incorporate the terms and conditions of this Agreement.
2.4.4. shall incorporate by reference the Study Plan for Services which shall be deemed part of the contract.
2.4.5. shall specify the Products & Services to be provided.
2.4.6. shall specify any conditions for the Products & Services; and
2.4.7. shall specify the price for the Products & Services and any assumptions relating to such price together with a payment schedule.
2.5. In the event that any of the assumptions included in the Scope of Work & Quotation(s) are deemed to be incorrect; scientific obstacles are identified during the provision of the Products & Services; there is a change in regulatory guidelines or requirements; or if the Sponsor requests a change or extension to the timelines for providing the Products & Services, Newcells shall provide a revised Scope of Work and/or Quotation for the Products & Services which shall be negotiated in good faith and agreed upon by the Parties and when agreed executed as an amendment to the respective Scope of Work & Quotation(s).
2.6. No purchase order shall be binding upon Newcells unless and until accepted by Newcells in writing, and Newcells shall have no liability or obligation to Sponsor with respect to orders that are not accepted. No partial shipment of an order shall constitute the acceptance of the entire order, absent the written acceptance of such entire order. Any provision in Sponsor’s Terms (if applicable) permitting Sponsor at its convenience to unilaterally change or cancel its purchase order (in whole or part) once accepted by Newcells shall be void and of no effect.
3. Sale of Products and use
3.1 Subject to the Terms, and to all applicable end user license agreement(s), notices, terms, conditions and/or use restrictions (if) printed on any Product packaging, label, Product user manual(s) or instructions, whether provided with the Product(s) or available for download, or insert, (ii) appearing in or included with the Newcells Documentation, (iii) listed on Newcells’s website, or (iv) provided herein, Newcells grants to the Sponsor a nonexclusive, nontransferable, non-sublicensable license to use the Product(s) sold and/or licensed to the Sponsor by Newcells or its authorized distributor only in accordance with the applicable, then-current Documentation for the Product purchased by the Sponsor, and no other use is authorized hereunder. No other license or authorization is granted, by implication, estoppel, or otherwise. For avoidance of doubt, no license, express or implied, is granted for Diagnostic Use.
3.2 The Sponsor agrees that it will not use the Products except in the conduct of the Research unless Provider otherwise agrees in writing. For the sake of clarity and not intending to limit the foregoing, the Sponsor acknowledges that the Products are intended exclusively for investigational use in in vitro studies and are not intended for use in human subjects. The Sponsor will not transfer the Products or provide access to the Products to any third party and will provide access only to those employees of the Sponsor who have a need for such Products for the sole purpose of conducting the Research. The Sponsor will exercise due care to ensure that the Products are handled only by trained laboratory personnel.
Without limiting the other restrictions contained in this paragraph, the Sponsor agrees that it will not perform any structural analysis, protein sequencing, reverse engineering or compound modification of the Products. The Sponsor will maintain true and accurate records regarding the handling, storage and physical movement of Products, and shall provide such records to Provider upon request. In handling, storing, utilizing and disposing of Products, The Sponsor shall, at all times, comply with all applicable laws, regulations and generally accepted industry standards, and will strictly follow all instructions, directions and procedures provided by Provider.
4. Term and termination of this agreement
4.1. This Agreement shall come into force on the date of purchase of the Deliverables and shall remain in force for three (3) years, unless terminated by the Sponsor as allowed under clause 4.3. Thereafter this Agreement shall renew automatically year on year for successive one (1) year periods unless either Party provides the other Party with written notice of its intention not to renew and extend this Agreement, such notice to be served at least sixty (60) days prior to the commencement of any such renewal term.
4.2. Either Party may terminate this Agreement and all relevant Scope of Work documents with immediate effect by notice in writing in the event that the other Party:
4.2.1. commits a material breach of any term of this Agreement or a Scope of Work which breach is irremediable or (if such breach is remediable) fails to remedy that breach within a period of thirty (30) days after being notified in writing to do so; or
4.2.2. repeatedly breaches any of the terms of this Agreement or a Scope of Work in such a manner as to reasonably justify the opinion that its conduct is inconsistent with it having the intention or ability to give effect to the terms of this Agreement; or
4.2.3. suspends, or threatens to suspend, payment of its debts or is unable to pay its debts as they fall due or admits inability to pay its debts or is deemed unable to pay its debts; or
4.2.4. suspends, or threatens to suspend, or ceases or threatens to cease to carry on, all or substantially the whole of its business; or
4.2.5. presents a petition or has a petition presented for its winding-up or has a receiver or an administrative receiver appointed of all or any part of its assets or undertaking or if a notice of intention to appoint an administrator is served in respect of it or calls a meeting of, or enters into any composition or arrangement with, its creditors; or
4.2.6. is subject to any event occurring, or proceeding is taken, in any jurisdiction that has an effect equivalent or similar to any of the events mentioned above.
4.3. Sponsor may terminate at any time without cause with ninety (90) days prior written notice.
4.4. Termination of this Agreement, or any Scope of Work, shall not relieve either Party of their obligations to the other in respect of:
4.4.1. maintaining the confidentiality of the Confidential Information.
4.4.2. ownership of and assignment of Inventions.
4.4.3. indemnification; and
4.4.4. compensation for the Services performed up to the effective date of the termination as well as irrevocable costs,
4.4.5. and any other Section which would reasonably survive the termination of this Agreement.
5. Fees, invoices and taxes
5.1. A price and payment schedule shall be detailed in the Scope of Work & Quotation(s) and based on the scope of Services. Invoices shall be issued in accordance with that price and payment schedule.
5.2. For Services provided with a stated duration of more than twelve (12) months, Newcells reserves the right to adjust prices annually based on the CPI rates published by the Organization for Economic Co-operation and Development (OECD) upon thirty (30) days prior written notice to the Sponsor. Newcells reserves the right to adjust the price of Services if the initiation of the work is delayed by more than 3 months beyond the original estimated start date as at the date of the Scope of Work where this delay is the result of action or inaction of the Sponsor.
5.3. The Sponsor shall pay Newcells’s invoices within thirty (30) days of the date of such invoices. Sponsor agrees that in the event of any delay in payment, overdue amounts shall bear interest at an annual rate applied by LIBOR plus two percent (2%) (compounded monthly), without prior notice of default being required, together with a minimum late payment fee of £40 or equivalent.
5.4. Should the Sponsor disagree with the accuracy of an invoice, the Sponsor shall notify Newcells of such inaccuracy within ten (10) working days of receipt of the invoice. The Sponsor agrees to pay the amounts for any items not in dispute and agrees not to unreasonably withhold payment.
5.5. The price for the Services under this Agreement shall not, and shall not be construed to include VAT, local, state, federal sales or use taxes, excise taxes, goods and service taxes, country specific business or professional services tax or similar tax on international services or foreign entities providing services or consumption taxes.
5.6. Payments made by the Sponsor under this Agreement shall be inclusive of any VAT, where applicable. Where VAT is properly chargeable on the Services provided under this Agreement, the Sponsor will pay such amount of VAT to Newcells on receipt of a valid tax invoice issued in accordance with the laws and regulations of the country in which the VAT is chargeable. If a valid tax invoice is not received, then the Sponsor has the right to withhold the VAT until Newcells submits a valid tax invoice.
5.7. All sums payable under this Agreement shall be paid in full without any deductions (including, but not limited to, deductions in respect of items such as income, corporation, or other taxes, charges and/or duties) except insofar as Sponsor is required by law to deduct withholding tax from sums payable to Newcells. If Sponsor is required by law to deduct withholding tax, then Sponsor and Newcells shall co-operate in all respects and take all reasonable steps necessary to (1) lawfully avoid the making of any such deduction or (2) enable Newcells to obtain a tax credit in respect of the amount withheld.
5.8. Newcells and the Sponsor shall work together with respect to any audits, disputes or requests for information with respect to the taxes in connection with or as a result of this Agreement. This commitment shall include the provision of all relevant information, documents and reasonable support. The provisions of this Clause 5.8 shall survive termination of the Agreement.
5.9. If the Sponsor requires a purchase order for the payment of Newcells invoices, the Sponsor shall provide the purchase order at the time of returning the signed Agreement and Scope of Work. Failure to provide a purchase order should not preclude the issue of an invoice in accordance with the payment schedule defined in the Scope of Work for milestones met or work performed, and the Sponsor shall be responsible for payment of all invoices.
6. Product and Delivery and Acceptance
6.1. Unless otherwise expressly indicated in the Quotation, Newcells’s liability as to delivery ceases, upon delivery of the Products at the F.O.B./FCA point. Unless specific shipping instructions have been agreed between Newcells and Sponsor, Newcells will ship in accordance with its standard practices.
6.2. Newcells does not guarantee any delivery dates and shall not be responsible for any loss or damage of any kind or nature whatsoever caused by any delay in delivery irrespective of the cause of such delay. Any provision in Sponsor’s Terms (if applicable) indicating a delivery date and/or that time is “of the essence” (or other terms of similar import) for delivery or other performance by Newcells shall be void and of no effect.
6.3. Delivery of Products shall be in accordance with Newcells’s then applicable manufacturing schedule and based upon a priority of ‘first order accepted; first order shipped’ basis.
6.4. Notwithstanding the foregoing, Newcells, in its sole discretion, may reprioritize scheduling of any delivery or deliveries of any orders accepted by Newcells. For multiple units and/or multiple Product orders Newcells may make delivery in installments, and each installment shall be deemed to be a separate sale. Newcells may issue a separate invoice for each installment, which invoice shall be paid without regard to prior or subsequent installments.
6.5. Sponsor must notify Newcells of any damaged or missing Products within five (5) days after receipt. Sponsor shall provide Newcells with the opportunity to inspect any shipment that includes any damaged or missing Product or component thereof, including through video, photo and/or in person inspection, at Newcells sole discretion. If Sponsor fails to comply with this section, Sponsor shall be deemed to have waived its rights to claim incorrect or incomplete delivery or packaging and any related warranty rights.
6.6. Products rejected by Sponsor will be held by Sponsor and may be returned only upon Newcells’s written authorization.
6.7. Newcells shall be entitled to repair or replace damaged, missing, and/or rejected Products in its sole discretion. These are Sponsor’s sole and exclusive remedies for rejected Products.
7. Limited Warranty for Products
7.1. Newcells warrants, only to Sponsor, that each Newcells Product purchased by Sponsor from Newcells hereunder, as delivered and under normal use will: as of the date of delivery to Sponsor, conform in all material respects to Newcells’s published specifications for such Product in effect at the time of delivery; and be free from defects in material and workmanship under normal use; in either case unless the applicable Quotation or Documentation states that a different warranty or no warranty is provided by Newcells.
7.2. All Newcells Product warranty remedies are subject to the condition that warranty claims must be received by Newcells in writing no later than thirty (30) days after the “use by” date or other end of recommended use date, on the Newcells Product’s label or in the accompanying Documentation is reached.
7.3. Sponsor’s exclusive remedy, and Newcells’s sole liability and obligation, under this warranty are replacing, or, at Newcells’s option, giving credit for, any Newcells Product not meeting the above warranty for which written notice is provided to Newcells within the applicable period.
7.4. The decision of whether to replace the Newcells Product or give credit will be made by Newcells in its sole discretion. Notwithstanding the foregoing, custom Newcells Product made to specifications of Sponsor are sold “AS IS”, without any warranty whatsoever, express or implied, except to the extent set forth in any separate express written limited warranty included in the Documentation provided with the Newcells Product or in the Quotation.
7.5. Except as set forth above, “use by” or other end of recommended use dates are included for informational purposes only and shall not be deemed as a period of warranty. This limited warranty is subject to certain exceptions detailed in Clause 7.6.
7.6. The foregoing warranties shall not apply to, and shall be void for, any Product that (i) was subject to improper or abnormal use or storage, abuse, neglect, negligence, accident, or the use of the Product with any non-Newcells product (except as may be specifically recommended, with respect to standard laboratory reagents, tools and equipment ancillary to use of the Product, in the then-current documentation for that Product); (ii) has been altered; or (iii) has failed due to externally caused short circuits, incorrect voltages, failure or fluctuation of electrical power, lightning, static or other improper external inputs, or due to civil unrest, threat of or actual acts of terrorism or war, embargoes, governmental actions, acts of God, earthquakes, floods, storms, fires, supplier delay, accidents, explosions, epidemics, quarantine restrictions, or other such contingencies beyond the reasonable control of the applicable party.
7.7. For clarity, and without limitation, any Sponsor attempt to alter any Product, except as may be specifically pre-authorized by Newcells in writing in each case, shall void the warranty for that Product.
7.8. These warranties are not transferable or assignable, including without limitation, in any resale of a Newcells Product, and any such attempt to transfer or assign these warranties shall be void for any unit to which they apply.
7.9. Newcells neither assumes, nor authorizes any other person to assume for it, any other obligations or liabilities in connection with the sale of Products.
7.10. The replacement of a Product shall not extend the original warranty period for that Product. Newcells’s warranties do not cover transportation of products.
8. Performance of Services
8.1. Newcells shall consult with the Sponsor and assist the Sponsor in developing the Study Plan and the design of the Services.
8.2. The Study Plan will, to the extent applicable to the Services, specify the study design, estimated duration and all other matters pertinent to the completion of the Services. Newcells or its Affiliates will perform the Services for the Sponsor in accordance with such Study Plan.
8.3. The nature of the Services is experimental and as such, any timelines or quantities shown in the Scope of Work or Study Plan are estimates only and assume the full co-operation of the Sponsor.
8.4. Where the Services are such that no guarantee or warranty can be provided as to the completion of the Services in accordance with the Study Plan, where the Services are not progressing effectively in the reasonable opinion of either Party, the Parties may agree to terminate the Services subject to the conditions of clause 4.4.
8.5. Newcells shall appoint a Study Manager who shall be responsible for the performance of the Services.
8.6. Where applicable to the Services the Parties will agree a Quality Agreement. Once executed the Quality Agreement may only be amended with the written consent of both Parties.
8.7. Newcells will perform the Services with due skill and care according to industry standards, the Study Plan, Quality agreement if applicable and this Agreement.
9. Sponsor Visits
9.1. The Sponsor or its representative (which shall not be a competitor of Newcells) may visit Newcells’s premises where the Services are being performed at reasonable times, on reasonable notice and with reasonable frequency during normal business hours to observe the progress of the Services. Newcells will assist the Sponsor in scheduling such visits.
9.2. The Sponsor acknowledges that the Sponsor’s representatives granted access to Newcells facilities during any such visits may have access to confidential and proprietary information of Newcells. The Sponsor agrees that all such confidential and proprietary information of Newcells obtained or observed by the Sponsor during such visits shall remain the sole property of Newcells and the Sponsor shall treat such information as Confidential Information in accordance with Section 10 of this Agreement.
10. Confidential Information
10.1. Each Party agrees that all Confidential Information of the disclosing Party is and shall be the sole property of the disclosing Party.
10.2. Without prejudice to any Newcells Property, all Results, data and records developed by Newcells or its Affiliates exclusively during the performance of the Services shall be the Confidential Information of the Sponsor.
10.3. Each Party agrees to hold the Confidential Information of the other Party in confidence and in a manner consistent with the way in which it maintains the confidentiality of its own proprietary information, being at least a reasonable standard of care. Each Party shall disclose the Confidential Information only on a need-to-know basis, to its employees, officers, directors, representatives and third-party investigators and who are bound to retain the Confidential Information in confidence.
10.4. Each Party agrees that except as necessary to fulfil its obligations under this Agreement or a Scope of Work, it will not use or disclose to any third party any of the Confidential Information.
10.5. The obligations of non-use and non-disclosure shall not apply to Confidential Information that the receiving Party can show:
a. was, or becomes, publicly known through no fault of the receiving Party.
b. was lawfully obtained from a third party without restriction as to its use or disclosure.
c. was already in the possession of the receiving Party prior to disclosure; or
d. was independently developed by the receiving Party without the benefit of the Confidential Information; or
e. is required for the pursuit of registration of a product connected with the Services with a government agency.
10.6. Each Party shall be entitled to disclose Confidential Information to the extent required by any law, rule, regulation, order, decree or subpoena, except that the Party required to disclose the Confidential Information shall, unless restricted by law or where not practicable, promptly notify the other Party of such requirement prior to the disclosure and shall cooperate with the other Party to seek to oppose, minimize or obtain the confidential treatment of the requested disclosure to the extent of such order.
The obligations in this Section 10 shall remain in full force and effect for a period of five (5) years following termination of this Agreement except with respect to Confidential Information which is considered a trade secret under applicable laws, which shall remain confidential as long as such Confidential Information retains its status as a trade secret.
In the event of actual or threatened breach or violation of this Section 10, the disclosing Party shall have the right to seek injunctive relief in any court of competent jurisdiction.
11. Work product/deliverables
11.1. All documents, including reports, will be prepared in a Newcells standard format unless otherwise agreed by the Parties.
11.2. Upon delivery of the any physical Deliverables, the Sponsor shall be responsible for carefully examining such Deliverables and the Sponsor shall be deemed to have accepted the same if Newcells has not been notified by the Sponsor within thirty (30) business days of delivery of any defect in the Deliverables.
11.3. Newcells expressly disclaims any responsibility for the safe use and disposal of any Deliverables, which are the full responsibility of the Sponsor.
12. Intellectual Property Rights
12.1. All Background IP is and shall remain the exclusive property of the Party owning it and except as expressly provided in this Agreement, no Party shall acquire any rights in or to the Background IP of the other Party.
12.2. The Parties agree that any improvement, enhancement or modification made, conceived or developed by Newcells to any Newcells Background IP in the performance of the Services which is not specific, or related directly to a Scope of Work, shall be deemed Newcells Background IP and shall vest absolutely and exclusively in Newcells. In addition, Newcells and its Affiliates shall be entitled to use and exploit any skills, techniques or know-how acquired, developed or used in the course of the Services.
12.3. Without prejudice to Sections 12.1 and 12.2, and upon receipt by Newcells of payment or installments thereof in the amounts due and payable under a Scope of Work, the Sponsor shall solely own all Deliverables and on request receive the Biological Samples produced under the applicable Scope of Work and any and all intellectual property rights arising therefrom.
12.4. Notwithstanding the foregoing, the Sponsor hereby grants Newcells an unrestricted, royalty-free license to aggregate and use any System Data produced by or for Newcells as part of the Services with other System Data owned or licensed by Newcells provided that Newcells shall not identify such data as belonging to the Sponsor.
13. Remedies and Limit of Liability
13.1. In the event of an error by Newcells that prevents the proper performance of the Services Newcells’s sole obligation to the Sponsor shall be for Newcells, in agreement with the Sponsor, to either:
(a) repeat the defective part of the Services at Newcells’s own cost, or
(b) refund to the Sponsor the amount paid for the defective part of the Services.
13.2. Neither Party’s total liability, whether in contract, tort (including negligence) or otherwise under any Scope of Work shall in no circumstances exceed the total price paid by the Sponsor for the Services that are the subject of that Scope of Work.
13.3. Nothing in this Agreement excludes or limits the liability of either Party where liability cannot be excluded or restricted as a matter of law.
13.4. In no event shall Newcells be liable to the Sponsor for any Loss arising under or in connection with this Agreement or Scope of Work in respect of any:
13.4.1. loss of profit, opportunity, business or goodwill (in each case whether direct or indirect); or
13.4.2. any indirect, consequential punitive, exemplary or special damages or losses,
13.4.3. and each type of loss arising under this Section 13.4 shall be severable in accordance with Section 4 of this Agreement.
13.5. Newcells shall not be liable for any failure, error or delay in performing the Services if such failure, error or delay is caused by Sponsor, or is a result of an express instruction from Sponsor or a change in Sponsor Information.
13.6. Newcells shall not be liable for, and the Sponsor will indemnify Newcells against any liability, loss, claim, damage, proceedings and costs whatsoever arising out of any actual or suspected infringement of any Intellectual Property of a Third Party as a result of the Sponsor’s use of the Deliverables or Biological Materials.
14. Indemnities
14.1. The Sponsor shall defend, indemnify and hold harmless Newcells and its Affiliates and their respective officers, directors and employees (the “Newcells Group”) from any Loss resulting from any Claim arising from or associated with, directly or indirectly:
14.1.1. the Sponsor’s use of the Deliverables or its use, consumption, sale, distribution or marketing of any substance tested in association with the Services provided by Newcells.
14.1.2. the negligence or intentional misconduct of the Sponsor; or
14.1.3. the infringement, unlawful disclosure or misappropriation of copyright, patent, trade secret or other intellectual property of a third party by reason of the performance of the Services using the Sponsor Information
14.1.4. provided that if such Losses or Claims arise in whole, or in part, from Newcells’s negligence or intentional misconduct, then the amount of such Losses that the Sponsor shall be responsible for pursuant to this Section 14.1 shall be reduced by an amount in proportion to the percentage of the Newcells Group’s responsibilities for such Losses as determined by a court of competent jurisdiction in a final and non-appealable decision or in a binding settlement between the Parties.
14.2. Newcells shall defend, indemnify and hold harmless the Sponsor and its Affiliates and their respective officers, directors and employees (the “Sponsor Group”) from any Loss resulting from any Claim arising from or associated directly with,
14.2.1. the negligence or intentional misconduct of Newcells,
14.2.2. Newcells’s execution and/or performance of its obligations under this Agreement or a Scope of Work.
14.2.3. the infringement, unlawful disclosure or misappropriation of copyright, patent, trade secret or other intellectual property of a third party by reason of the performance of the Services using the Newcells Background IP or the Biological Material.
14.2.4. the infringement, unlawful disclosure or misappropriation of copyright, patent, trade secret or other intellectual property of a third party by reason of using the Deliverables.
14.2.5. provided that if such Losses or Claims arise in whole, or in part, from the Sponsors Group’s negligence or intentional misconduct, then the amount of such Losses that the Newcells shall be responsible for pursuant to this Section 14.2 shall be reduced by an amount in proportion to the percentage of the Sponsor Group’s responsibilities for such Losses as determined by a court of competent jurisdiction in a final and non-appealable decision or in a binding settlement between the Parties.
14.3. The Party entitled to indemnification under Section 14 (the Indemnified Party) shall give written notice to the other Party (Indemnifying Party) of a claim or other circumstances likely to give rise to a request for indemnification, within thirty (30) days after the Indemnified Party becomes aware of the same.
14.4. The Indemnifying Party shall be afforded the opportunity to undertake the defense of, and to settle by compromise, or otherwise, any claim for which indemnification is available under this Section 14
14.5. If the Indemnifying Party assumes the defense of any claim, the Indemnified Party may participate in such defense with legal counsel of its selection and at its expense. If the Indemnifying Party, prior to the expiration of thirty (30) days after receipt of written notice of a claim by the Indemnified Party under this Section 14.5, has not assumed the defense thereof, the Indemnified Party may thereupon undertake the defense on behalf of, at the risk and expense of, the Indemnifying Party with all reasonable costs and expenses of such defense to be paid by the Indemnifying Party.
14.6. In the event that the Indemnified Party assumes the defense of any claim, no compromise or settlement of any such claim shall be made without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld or delayed.
15. Insurance
Each Party shall secure and maintain in full force and effect throughout the performance of the Services the necessary insurance coverage in amounts appropriate to the conduct of its business. Certificates evidencing such insurance will be made available for examination upon written request by either the Sponsor or Newcells.
16. Biological Material
Where the Newcells supplies Biological Material to the Sponsor, Newcells represents and warrants that:
16.1. all Biological Material supplied or used under this Agreement are or have been procured, produced and supplied to Newcells ethically in full compliance with any and all applicable national laws, regulations, or codes of practice relating to the Biological Material providing protection for human subjects in the country of origin.
16.2. any Donor has given Informed Consent that is appropriate for the intended use of the Biological Material.
16.3. all human Biological Material will be supplied to the Sponsor without any information or data that could result in the Donor being personally identifiable by the Sponsor, under applicable data protection/privacy laws; and
16.4. all human Biological Material supplied to the Sponsor were procured without inappropriate financial benefit to the Donor.
16.5. Newcells shall upon request, provide a copy of the relevant Informed Consent template or, if applicable, any amended template to the Sponsor under separate cover.
16.6. In the event of a withdrawal of, or a material variation to, the Informed Consent which may affect the Services provided by Newcells and/or the use of the Biological Materials by the Sponsor, Newcells shall promptly notify the Sponsor of such changes.
16.7. The Sponsor agrees to use the Biological Materials in accordance with all applicable national laws, regulations and codes of practice.
16.8. Upon the Newcells request, the Sponsor shall retain, return or destroy all Biological Materials in accordance with the Informed Consent, the Newcells instructions or any other specific requirements under applicable national law.
16.9. Sponsor acknowledges that where Newcells enters into a material transfer agreement (“MTA”) with the provider of any tissue samples from which Biological Materials are derived, Newcells shall act in accordance with the terms of the MTA and the disposition of the relevant HBS shall be as prescribed in the MTA. In the event of a conflict between the terms of the MTA, this Agreement, a Scope of Work and any instructions provided by Sponsor, the terms of the MTA shall prevail.
17. Subcontractors
17.1. Newcells may subcontract certain tasks, as may be agreed during the development of and specified in the Study Plan, to Subcontractors or to its Affiliates. Newcells shall be responsible for the performance of Subcontractors and Affiliates.
17.2. Newcells shall not be responsible for performance by third-party Vendors. Liability of Newcells to the Sponsor with respect to such Vendors shall be limited to the extent Newcells is negligent in the performance of its obligations under this Agreement. Newcells shall provide to the Sponsor any amounts that Newcells may recover from such Vendors as a result of any error or service failure on the part of the Vendors in connection with this Agreement or any Services under a Scope of Work.
18. Force Majeure
18.1. Neither Party shall be in breach of this Agreement or a Scope of Work nor liable for delay in performing, or failure to perform, any of its obligations under this Agreement, or Scope of Work as appropriate, if such delay or failure result from a Force Majeure Event. In such circumstances, any time specified for completion of performance in the Study Plan falling due during or subsequent to the occurrence of a Force Majeure Event shall be automatically extended for a period of time equal to such event.
18.2. Should any part of the Services be rendered invalid as a result of a Force Majeure Event, Newcells shall, upon written request from the Sponsor, and at the Sponsor’s sole cost and expense, repeat the affected part of the Services.
18.3. Newcells will promptly notify the Sponsor if, by reason of a Force Majeure Event Newcells is unable to meet any deadline specified in a Scope of Work.
19. Delay or Cancellation of Services
19.1. If the scheduled start up of the Services are to be postponed due to (a) request by the Sponsor, or (b) reasons that are directly linked to the Scope of Work and outside the control of either Party. Newcells reserves the right to re-allocate resources otherwise reserved for performance of the Services without incurring liability to the Sponsor and to levy a reasonable charge for committed costs or cost increases due to inflation during a Sponsor delay.
19.2. The Sponsor may terminate a Scope of Work prior to completion of the Services by giving written notice of such termination to Newcells. In case of such termination, the Sponsor shall pay Newcells all reasonable unrecoverable or costs.
20. Independent Contractor
Newcells and/or its Affiliates shall perform their duties as an independent contractor and shall have complete and exclusive control over its employees and agents. Newcells will have no authority to bind or commit the Sponsor in any manner whatsoever and will not, at any time, hold itself out to third parties as having authority to enter into or incur any commitments, expenses, liabilities or obligations or any nature on behalf of the Sponsor, except pursuant to this Agreement and the Scope of Work.
21. Assignment
21.1. Newcells may assign, transfer or subcontract any or all of its rights and obligations under this Agreement or a Scope of Work to its Affiliates.
21.2. Subject to Section 21.1 and except in connection with either an internal reorganization of the relevant Party’s corporate structure, this Agreement shall not be assigned (in whole or in part) by either Party without the prior written consent of the other, which consent shall not be unreasonably withheld or delayed.
22. Notices
22.1. Except as otherwise provided, all communications and notices required under this Agreement shall be in writing and deemed to be given if delivered personally, or mailed by overnight delivery or first class mail, postage prepaid, to the addresses set forth below, or via electronic mail or facsimile with hard copy confirmation, or to such other addresses as the parties from time to time specify in writing.
22.2. Notices shall be treated as having been given upon delivery if delivered by hand or by commercial courier at the time of signature of receipt; if sent by prepaid first class mail or recorded delivery three (3) days from the date of posting; if by facsimile or electronic mail, at the time of transmission and if by airmail seven (7) days from the date of posting.
22.3. Notice shall be given to the parties at the addresses listed below:
As to Newcells:
Newcells Biotech Limited
The Biosphere,
Drayman’s Way,
Newcastle Helix
Newcastle upon Tyne,
NE4 5BX,
United Kingdom
Attention: Chief Executive Officer As to Sponsor:
ATTN: _________________
For the purposes of this Section 22, in relation to the purposes of any legal proceeding, “writing” shall not include email.
23. Waiver
23.1. A waiver of any term, provision or condition of this Agreement or Scope of Work shall be effective only if it is in writing and no waiver, in any one or more instances shall be deemed to be or construed as a further or continuing waiver or estoppel of any such term, provision or condition or any other term of this Agreement or the Scope of Work.
23.2. No failure or delay by either Party in exercising any right or remedy under this Agreement shall constitute a waiver of such right, nor shall it prevent or restrict its further exercise.
24. Variation
No provision of this Agreement or the Scope of Work may be amended, modified, varied, discharged or terminated except by the express written agreement of both Parties and signed by an authorized representative of each Party.
25. Severability
25.1. If any court or competent authority finds that any provision of this Agreement (or part of any provision) is invalid, illegal or unenforceable, that provision or part-provision shall, to the extent required, be deemed to be deleted, and the validity and enforceability of the other provisions of this Agreement shall not be affected.
25.2. If any invalid, unenforceable or illegal provision of this Agreement would be valid, enforceable and legal if some part of it were deleted, the provision shall apply with the minimum modification necessary to make it legal, valid and enforceable.
26. Publicity
26.1. Neither Party will use the name, trademark or the name of any representative of the other, or the existence of this Agreement for any promotional or advertising purposes, or any other publication, without the prior written consent of the other. Such restrictions shall not apply to internal communications and publications to a Party’s Affiliates.
26.2. Sponsor shall provide Newcells with a pre-publication copy of any report, manuscript, publication or form of marketing material recognizing Newcells’s participation in the Services or otherwise identifying Newcells, for approval (which approval shall not be unreasonably withheld or delayed) in each case at least thirty (30) days before its submission for publication.
27. Entire Agreement
This Agreement represents the entire understanding between the Parties with respect to the subject matter hereof as at the date of purchase of Deliverables and as such, supersedes all prior and contemporaneous negotiations, agreements, representations, understandings, and commitments with respect thereto except that any written agreement entered into prior to the date of purchase of Deliverables with respect to Services in progress prior to the date of purchase of Deliverables shall remain effective and shall continue to govern such Services. The Parties agree that neither has relied upon prior representations made before executing this Agreement.
28. Third Party Rights
Except as expressly set forth in this Agreement in respect of Newcells Affiliates, nothing in this Agreement is intended to confer any rights, benefits or remedies of any kind whatsoever, and a person who is not a party to this Agreement shall have no right to enforce any of its terms.
29. Anti-Bribery
29.1. Both Parties agree that each has not and will not, either directly or indirectly, engage in bribery, or offer, or promise, or authorize to pay or make any improper payment of any monies or financial or other advantage, including cash, loan, gift, travel, entertainment, hospitality, facilitation payment, kickback, political or philanthropic contribution, anything of value, or any other perceived benefit to improperly obtain or retain a business advantage in violation of any Anti-Corruption Laws and further, each Party agrees that they shall not take any action that would cause the other Party to be in violation of such Anti-Corruption Laws.
29.2. Any breach of Section 29.1 by a Party shall allow the other Party to immediately terminate this Agreement and any Scope of Work.
30. No Solicitation
The Sponsor agrees that it will not solicit or otherwise encourage any Newcells or Affiliate employee with whom it has contact pursuant to this Agreement to seek employment with the Sponsor throughout the course of this Agreement and for a period of twelve (12) months thereafter.
31. Counterparts
This Agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute an original to this Agreement but all of which together shall constitute the same Agreement.
32. Choice of Law and Jurisdiction
32.1. All matters affecting the interpretation, validity and performance of this Agreement shall be governed by English Law.
32.2. The parties irrevocably agree that any dispute or claim arising out of or in connection with this Agreement or its subject matter or formation (including non-contractual disputes or claims) shall be governed by the exclusive jurisdiction of the courts of England.
32.3. No claim or action arising out of or relating to this Agreement, or any Scope of Work may be brought by a Party more than two (2) years after the cause of action has accrued.
32.4. In the event that any Party commences legal proceedings against the other Party in connection with this Agreement, the Party prevailing through a final non-appealable decision of the court of competent jurisdiction shall be entitled to recover its costs and expenses of litigation (including reasonable attorneys’ fees) from the other Party.
