New England Biolabs Lyophilization Sciences

NEB Lyo Sciences R&D Terms & Conditions

Interpretation and Acceptance

1.1. Definitions. In these terms and conditions, the following terms have the following meanings:

“Affiliate” means any corporation or business entity, which directly or indirectly (i) controls a Party, (ii) is controlled by a Party, or (iii) is under common control with a Party (the terms “controls” and “controlled” meaning (a) ownership of more than fifty percent (50%) of the voting rights and equity of such corporation or business entity and/or (b) the power to direct the management of such corporation or business entity).

“Background Intellectual Property” means any Intellectual Property of a Party that is (a) owned or controlled by such Party and/or its Affiliates as of the Effective Date, or (b) created, developed, or conceived by, or on behalf of, such Party and/or its Affiliates outside of the scope of the Contract, including any improvement, enhancement, or modification of or derivative work based on such Intellectual Property.

“Contract” means these Terms, including all documents incorporated herein by reference, a Quote, if any, and those specific terms of a purchase order or other document that are either consistent with these Terms or expressly agreed upon by the Parties in writing.

“Customer” means the person, firm, company or entity who requests Services from NEB Lyo Sciences™.

“Customer Material” means all materials provided by Customer, its authorized agents, or its designees to NEB Lyo Sciences for use by NEB Lyo Sciences in its performance of Services, including, without limitation, primers, probes, enzymes, and templates, together with any related material, information, and/or associated know-how and data received by NEB Lyo Sciences from Customer, its authorized agents, or its designees.

“Effective Date” means the date on which Customer is deemed to have accepted these Terms pursuant to clause 1.3 hereof.

“NEB Lyo Sciences” means New England Biolabs Lyophilization Sciences Ltd., a United Kingdom private limited company (Company Number 7754376) with a principal place of business at 178 Brook Drive, Milton Park, Abingdon, Oxfordshire, OX14 4SD United Kingdom.

“Intellectual Property” means, individually and collectively, any and all rights of any kind or nature, title, or interests in or to or arising from any of the following, whether or not filed, perfected, acquired, registered or recorded and whether existing now or being recognized or created in the future including all renewals thereof, all anywhere throughout the world and under any law or legal system: (a) patents and continuations, divisions, corrections, extensions or substitutions thereof, (b) utility models, (c) inventions, discoveries, and improvements, (d) copyrights, copyright registrations, copyright applications, copyrightable works and other related rights, (e) moral rights, rights of attribution, and integrity, (f) trademarks and service marks, business names and domain names, rights in get-up, goodwill and the right to sue for passing off or unfair competition, (g) rights in designs, (h) databases and data collections, (i) confidential information (including know-how and trade secrets), (j) semiconductor topography rights, (k) specifications, formulae, data, processes, methods, techniques, or technology, and (l) all applications, registrations, petitions, and requests seeking of (a) – (k) including, without limitation, rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection.

“Lyophilised Material” means any and all lyophilised material arising from NEB Lyo Sciences' performance of the Services.

“Party” means Customer or NEB Lyo Sciences, and “Parties” means Customer and NEB Lyo Sciences.

“Quote” means a quote or quotation issued to Customer by NEB Lyo Sciences setting forth, as applicable, the scope of the Services, any phases for the Services, any deliverable timescales, the prices for the Services, and any other relevant terms.

“Services” means the research, technical, developmental, and related services, including qualification and process validation and the development of tooling and tooling prototypes, performed by or on behalf of NEB Lyo Sciences in performance of the Contract, including such services related to lyophilising Customer Material or lyophilising other material(s) at Customer’s request. For purposes of the Contract, the term “Services” excludes any manufacturing, production, commercialization, and related services.

“Terms” means the terms and conditions set out in this document.

1.2. References. References to statutes or statutory provisions include the same as amended, modified, consolidated or re-enacted whether before or after the date of the Contract; references to persons include incorporated and unincorporated persons; references to the singular include the plural and vice versa and references to clauses mean to clauses in these Terms.

1.3. The Parties acknowledge and agree that the Contract, including these Terms, constitutes the terms and conditions under which NEB Lyo Sciences provides Services to Customer and that the Contract will govern all Customer orders of Services from NEB Lyo Sciences. NEB Lyo Sciences' provision of Services to Customer is expressly conditioned upon Customer’s acceptance of these Terms. Customer will be deemed to have accepted these Terms and any applicable Quote from NEB Lyo Sciences upon the earliest to occur of (a) Customer’s written acceptance of such Quote, (b) Customer’s submission of a purchase order or other request for Services, whether pursuant to a Quote or otherwise, or (c) Customer’s transfer of Customer Material to NEB Lyo Sciences or NEB Lyo Sciences’ acquisition from Affiliates or third-parties of material (including, without limitation, reagents) deemed necessary by NEB Lyo Sciences for the performance of the Services. NEB Lyo Sciences' failure to object to any terms and conditions contained in any purchase order or other Services request or document from Customer will not be construed as NEB Lyo Sciences' acceptance of such terms and conditions or as NEB Lyo Sciences' waiver of these Terms.

2. Customer Material

2.1. Material Transfer. Customer will transfer to NEB Lyo Sciences (a) sufficient Customer Material required for NEB Lyo Sciences' performance of the Services, and (b) any related information reasonably requested by NEB Lyo Sciences or determined by Customer to be necessary for NEB Lyo Sciences' performance of the Services. Customer will use best efforts to provide a single batch of the Customer Material required by NEB Lyo Sciences for its performance of the Services. If Customer provides Customer Material in multiple batches, then NEB Lyo Sciences may (i) charge Customer for any reasonably necessary goods-in quality control or equivalence studies it conducts and invoice Customer for such studies in accordance with the invoicing terms set forth in clause 4 hereof, and (ii) alter, in its sole discretion, any phase, Service, research and development, or Lyophilised Material timescales and deliverable schedules, in each case, as applicable, as set forth in the Contract or other communications to Customer.

2.2. Customer Material. Customer will retain all right, title and interest, including, but not limited to, Intellectual Property rights, in and to the Customer Material. NEB Lyo Sciences will use the Customer Material solely for the purpose of performing the Services, and Customer grants to NEB Lyo Sciences a non-exclusive, non-transferable right to use the Customer Material solely for the purpose of performing the Services. Customer Material will not be used in humans or for testing of humans for any purpose. NEB Lyo Sciences will not, without Customer’s prior written consent, (a) sell, distribute or transfer Customer Material to any other person or entity other than its personnel who require access to the Customer Material to perform the Services, (b) perform compositional, structural, functional or other analysis of the Customer Material or undertake deconvolution or reverse engineering with respect to the Customer Material except as may be necessary for the performance of the Services, or (c) seek to obtain or obtain any patent right in or to the Customer Material. Further, NEB Lyo Sciences will take reasonable precautions at least as stringent as those observed by NEB Lyo Sciences to protect its own proprietary material to protect the confidentiality of and limit use of Customer Material in accordance with NEB Lyo Sciences' confidentiality and non-use obligations under the Contract. NEB Lyo Sciences will comply with all applicable laws and regulations applicable to it with respect to the use, storage, handling, export, re-export, disposal and transfer of Customer Material while such Customer Material is in NEB Lyo Sciences' possession and control, and NEB Lyo Sciences assumes sole responsibility for any violation by it of such laws or regulations so long as Customer has disclosed all information about the nature, composition, and properties of such Customer Material necessary for NEB Lyo Sciences to comply with such laws and regulations. Except as expressly stated in this clause 2.2, Customer’s delivery of the Customer Material to NEB Lyo Sciences will provide NEB Lyo Sciences with custody of the Customer Materials and will not constitute a sale thereof or a grant, option or license under any patent or other rights owned or controlled by Customer or creation of a bailment. Notwithstanding the foregoing, Customer acknowledges some or all of the Customer Material provided to NEB Lyo Sciences hereunder may be consumed in the performance of the Services. NEB Lyo Sciences will destroy any remaining Customer Material in its possession or control within thirty (30) days after the earliest to occur of (i) the expiry date, if any, of Customer Materials, (ii) a written request from Customer, and (iii) expiration or termination of the Contract.

2.3. Shipping. Customer, at its sole cost and risk of loss, will ship, or arrange for the shipment of, all Customer Material to be provided under the Contract to any location specified in writing by NEB Lyo Sciences. Customer represents and warrants it has all necessary rights, including Intellectual Property rights, to transfer the Customer Material to NEB Lyo Sciences for the purposes described herein. All Customer Material at risk of environmental contamination of manufacturing facilities (including, for example, nucleic acids) will be shipped in separate containers and delineated within the shipment container so that the Customer Material and shipment container may be properly handled and opened in a manner that avoids environmental contamination. Customer will endeavour, if applicable, to use screw cap vials prior to shipment to reduce the risks of such environmental contamination. All Customer Material will be clearly labeled with the following information (if applicable): product name; code; quantity, value, EU Tariff code, concentration (in standard international units when possible); storage conditions; expiration date; and LOT number. If Customer provides Customer Material deficient in labelling or packaging, then NEB Lyo Sciences may charge Customer for any time it takes for NEB Lyo Sciences to rectify such deficiencies, and any such charges will be invoiced to Customer in accordance with the invoicing terms set forth in clause 4 hereof.

2.4. Handling Instructions. Prior to or in conjunction with delivery of any Customer Material, Customer, or a third-party on its behalf, will provide NEB Lyo Sciences with associated safety data sheets, safe handling instructions, health and environmental information, certificates of analysis or compliance or a raw material specification, as applicable, and regulatory certifications or authorizations that may be required under applicable law or regulation.

3. Services and Lyophilised Material.

3.1. Lyophilised Material. NEB Lyo Sciences will perform the Services using any Customer Material provided to it under the Contract, any other third-party materials requested by Customer and agreed upon by NEB Lyo Sciences, and any other materials deemed necessary by NEB Lyo Sciences. NEB Lyo Sciences will, from time to time, provide Customer with updates of its progress in performing the Services. If the Services result in the production of Lyophilised Material, then NEB Lyo Sciences will transfer a sample of such Lyophilised Material to Customer. Customer will use the Lyophilised Material solely to evaluate the Lyophilised Material’s performance. Such evaluation may include studies undertaken by Customer. Customer acknowledges Lyophilised Material is for its internal evaluation and research use only and will not be used for human or animal therapeutic or diagnostic uses and will not otherwise be used in, or for the testing of, humans or animals. Customer will not, without NEB Lyo Sciences' prior written consent, (a) sell, distribute or transfer Lyophilised Material to any other person or entity other than its laboratory personnel who require access to the Lyophilised Material for the foregoing evaluation purposes, (b) perform compositional, structural, functional or other analysis of the Lyophilised Material or undertake deconvolution or reverse engineering with respect to the Lyophilised Material, or (c) seek to obtain or obtain any patent right in or to the Services (including any tooling or tooling prototypes created or developed in connection with the Services) or the Lyophilised Material. Customer will take reasonable precautions at least as stringent as those observed by Customer to protect its own proprietary material to protect the confidentiality of and limit use of Lyophilised Material in accordance with Customer’s confidentiality and non-use obligations under the Contract. Customer will comply with all applicable laws and regulations applicable to it with respect to the use, storage, handling, export, re-export, disposal and transfer of the Lyophilised Material, and assumes sole responsibility for any violation by it of such laws or regulations. Except as expressly stated in this clause 3.1, NEB Lyo Sciences' transfer of the Lyophilised Material to Customer will not constitute a sale thereof or a grant, option or license under any patent or other rights owned or controlled by NEB Lyo Sciences or creation of a bailment, and NEB Lyo Sciences will be under no obligation to disclose any of its proprietary processes or materials under or in connection with the Contract. Unless otherwise agreed to by NEB Lyo Sciences in writing, within thirty (30) days after the earlier of a written request from NEB Lyo Sciences or termination of the Contract, Customer will destroy any Lyophilised Material in its possession or control. Unless otherwise agreed to by NEB Lyo Sciences in writing, the Lyophilised Material will not be provided with any certificates of analysis, raw material specifications, or other documentation.

3.2. Customer Acknowledgements. Customer acknowledges that (a) the Services are considered research and development and there is a likelihood that (i) NEB Lyo Sciences will be unable to develop Lyophilised Material, (ii) performance of the Services will consume up to all of the Customer Material provided to NEB Lyo Sciences, and/or (iii) Lyophilised Material will not have desired properties and/or will not be suitable for any desired purpose, (b) activities associated with Customer’s commercial launch of a product, whether comprised of or including Lyophilised Material, are not included within the scope of Services provided by NEB Lyo Sciences hereunder, (c) NEB Lyo Sciences is not providing any services, whether commercial, manufacturing, production, or otherwise, other than the Services, and (d) notwithstanding any provision in the Contract to the contrary, NEB Lyo Sciences will not be obligated to provide or disclose, and Customer will have no right to receive or have disclosed to it, any Background Intellectual Property of NEB Lyo Sciences and/or any Intellectual Property of NEB Lyo Sciences relating to the Lyophilised Material or the Services.

3.3. NEB Lyo Sciences Acknowledgements. NEB Lyo Sciences acknowledges that (a) Customer’s evaluation of Lyophilised Material under clause 3.1 will consume up to all of the Lyophilised Material provided to Customer, and (b) notwithstanding any provision in the Contract to the contrary, Customer will not be obligated to provide or disclose, and NEB Lyo Sciences will have no right to receive or have disclosed to it, any Background Intellectual Property of Customer and/or any Intellectual Property of Customer relating to the Customer Material except as may otherwise be required hereunder.

3.4. Intellectual Property. NEB Lyo Sciences retains all interest, right, title, and ownership of its Background Intellectual Property, and, except for the limited rights of use specified in clause 3.1, no provision in the Contract will grant ownership of and/or rights of use of such Background Intellectual Property to Customer. The Parties acknowledge and agree that NEB Lyo Sciences owns any improvement, enhancement, or other modification of or derivative work based on any of its Background Intellectual Property made by or on behalf of NEB Lyo Sciences or Customer. Each Party agrees that NEB Lyo Sciences owns, and will retain, all right, title and interest, including, but not limited to, Intellectual Property rights, in and to the Lyophilised Material, in and to the application of any processes or incorporation of any excipients or preservatives so as to develop or create Lyophilised Material, and any deliverables resulting from the Services, including tooling and tooling prototypes. Customer hereby assigns to NEB Lyo Sciences all worldwide right, title and interest in and to any improvement, enhancement, or other modification of or derivative work based on NEB Lyo Sciences' Background Intellectual Property, the Lyophilised Material, or deliverables resulting from the Services, including tooling and tooling prototypes, made or conceived by or on behalf of Customer. Said assignment will be automatic under the Contract, without the need to be evidenced further in writing. At NEB Lyo Sciences' expense, Customer will execute, or cause to be executed, all documents and perform such acts as may reasonably be necessary to secure or enforce for NEB Lyo Sciences statutory protection, including patent, trademark, trade secret or copyright protection, throughout the world for such improvements, enhancements, or other modifications or derivative works.

3.5. Shipping. Customer shall be responsible for importing Lyophilised Material shipped to any destination outside of the United Kingdom. Unless otherwise agreed by the Parties in writing, all shipments by NEB Lyo Sciences of Lyophilised Material to Customer will be Ex Works (Incoterms 2020) NEB Lyo Sciences' principal place of business (the “Delivery Point”). Lyophilised Material is deemed delivered upon tender of delivery to the carrier at the Delivery Point. Customer shall specify the method of transportation and the common carrier to be used, provide all applicable customer account numbers and labelling for such carrier, and arrange for collection at the Delivery Point. If Customer does not provide the information required in the preceding sentence, then NEB Lyo Sciences shall ship the Lyophilised Material by a common carrier of its own selection and invoice Customer for all applicable charges associated with such shipment. Risk of damage to or loss of the Lyophilised Material shall pass to Customer upon tender of delivery of the Lyophilised Material to the carrier at the Delivery Point.

4. Compensation.

The prices for any Services provided by NEB Lyo Sciences hereunder will be as set forth in the applicable Quote; provided that if no such prices are set forth in a Quote or if there is no Quote, then the prices for such Services will be calculated on a time and materials basis in accordance with NEB Lyo Sciences' standard rates in force at the time the relevant Services are provided. If applicable, NEB Lyo Sciences will also charge Customer for (a) the use by NEB Lyo Sciences of its dryers, which charge will include costs related to dryer start-up, operation, and post-run cleansing between operations as well as gas and vacuum oil, (b) laboratory activities, charged on a per diem rate depending on the specific laboratory utilised in the performance of the Services, (c) NEB Lyo Sciences’ costs to purchase or acquire third-party or Affiliate materials requested by Customer or otherwise required to perform the Services, and (d) NEB Lyo Sciences’ costs to develop, or have developed, tooling or tooling prototypes for the performance of the Services (such charges in preceding clauses (a) and (d), the “Additional Charges”). NEB Lyo Sciences will invoice Customer prior to the commencement of Services for any deposit required under the Contract, and NEB Lyo Sciences will invoice Customer for any Services it performs under the Contract and, if applicable, any Additional Charges, on a monthly basis. Invoices will be sent to the mailing or e-mail address specified in a Quote or as specified in other written communication from Customer, and each invoice will state, as applicable, the amount of the deposit, the price for the Services, and any related Additional Charges, plus any taxes (including VAT), shipping charges for Lyophilised Material, and any other costs incident to the Services to be paid by Customer. Customer will pay each invoice (without any deduction or set-off) within thirty (30) days of the date of such invoice. If Customer fails to make any payment in full by the due date of such payment, then, without prejudice to any other right or remedy available to NEB Lyo Sciences and without any liability from NEB Lyo Sciences to Customer, NEB Lyo Sciences may charge Customer interest on any outstanding amount, before and after judgment, at the lower of (a) a rate of five percent (5%) above the base rate of Barclays Bank plc in the UK, calculated annually but accruing on a daily basis, and (b) the highest rate allowed by applicable law. In addition to any other remedy that NEB Lyo Sciences may have at law or equity, NEB Lyo Sciences may stop performance of Services without violation of the Contract in the event that Customer’s payment is sixty (60) days past due for any outstanding invoice. Upon payment in full of such outstanding invoices (including applied interest), NEB Lyo Sciences will recommence performance of Services hereunder. NEB Lyo Sciences may, upon such recommencement and in its sole discretion, alter any phase, Service, research and development, or Lyophilised Material timescales and deliverable schedules, in each case, as applicable, as set forth in the Contract or other communications to Customer. All charges hereunder, and all payments thereof, will be in Pounds Sterling.

5. Confidential Information.

5.1. Confidential Information. As used herein, the term “Confidential Information” includes, without limitation, any know-how, technical, scientific, business or other information that may be disclosed by one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) in connection with the Contract, regardless of whether such information is specifically designated as confidential and regardless of whether such information is in written, oral, electronic, or other form. Confidential Information will not be deemed to include information which the Receiving Party can demonstrate by competent written proof: (i) was in the public domain or the Receiving Party’s possession prior to the time of its disclosure under the Contract; (ii) entered the public domain after the time of its disclosure under the Contract through means other than an unauthorized disclosure resulting from an act or omission by the Receiving Party; (iii) is independently developed by the Receiving Party without use of the Confidential Information; or (iv) is disclosed to the Receiving Party by a third-party having the right to make such disclosure. 

5.2. Legal Disclosure. Notwithstanding any other provision of the Contract to the contrary, disclosure of Confidential Information will not be prohibited to the extent required to comply with applicable laws or regulations, or with a valid court or administrative order, provided that the Receiving Party: (i) promptly notifies the Disclosing Party in writing of the existence, terms and circumstances of such required disclosure; (ii) consults with the Disclosing Party on the advisability of taking legally available steps to resist or narrow such disclosure; and (iii) takes all reasonable and lawful actions to obtain confidential treatment for such disclosure.

5.3. Non-Use and Non-Disclosure. The Receiving Party agrees that it will, until the fifth (5th) anniversary of the Effective Date: (i) protect the Confidential Information with the same degree of care as it normally uses to preserve and safeguard its own proprietary information of like nature, but not less than a reasonable degree of care; (ii) use the Confidential Information solely for the purposes of the Contract and not for any other purpose without the express prior written permission of the Disclosing Party; and (iii) disclose the Confidential Information only on a need-to-know basis to effect the purposes of the Contract and only to its and its Affiliates’ employees, advisors, representatives, and agents, including its personnel who require access to the Customer Material and Lyophilised Material, as applicable, for the purposes described herein, who have undertaken an obligation of confidentiality substantially similar to that contained herein.

5.4. Return or Destruction. Upon the request by the Disclosing Party, the Receiving Party will, at its election, either return to the Disclosing Party or destroy (providing a signed certificate of complete destruction), all originals, copies, and summaries of documents, and other tangible manifestations, to the extent that they contain Confidential Information, in the possession or control of the Receiving Party; provided, however, that (a) one (1) copy of the Confidential Information may be retained by the Receiving Party for the sole purpose of monitoring its ongoing obligations hereunder, and (b) the Receiving Party shall not be obligated to delete electronic copies of the Disclosing Party’s Confidential Information which had been automatically stored on the Receiving Party’s data protection backup systems.

6. General

6.1 No Warranties. ANY LYOPHILISED MATERIAL OR OTHER DELIVERABLES, INCLUDING TOOLING AND TOOLING PROTOTYPES, PROVIDED BY NEB LYO SCIENCES TO CUSTOMER HEREUNDER IS PROVIDED “AS IS”, IS UNDERSTOOD BY CUSTOMER TO BE EXPERIMENTAL IN NATURE, AND IS PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING OF NON-INFRINGEMENT, QUALITY, OR REGARDING RESULTS OBTAINED THROUGH THE USE OF THE LYOPHILISED MATERIAL OR OTHER DELIVERABLE, WHETHER ARISING FROM A STATUTE OR OTHERWISE IN LAW OR FROM A COURSE OF PERFORMANCE, DEALING OR USAGE OF TRADE, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED. NEB LYO SCIENCES FURTHER MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, THAT THE POSSESSION, ANALYSIS, OR USE OF THE LYOPHILISED MATERIAL OR ANY OTHER DELIVERABLES PROVIDED IN CONNECTION HEREWITH, INCLDUING TOOLING AND TOOLING PROTOTYPES, WILL NOT INFRINGE ANY PATENT OR OTHER INTELLECTUAL PROPERTY OR PROPRIETARY RIGHT OF A THIRD-PARTY.

6.2. Customer Indemnification. To the extent allowed by applicable law, and except where a claim arises as a result of NEB Lyo Sciences' gross negligence or willful misconduct, Customer assumes all liability for, and agrees to indemnify, defend and hold harmless NEB Lyo Sciences and its Affiliates and its and their respective directors, officers, employees, representatives, and agents against, all losses, expenses (including without limitation any reasonable legal fees and expenses), claims, demands, damages, judgments, suits or other actions arising from: (a) the use, modification, sale, resale, storage, handling, export, re-export, disposal, or transfer of, or other acts or omissions related to the Lyophilised Material or any other deliverable, including tooling and tooling prototypes, delivered in connection herewith or any final articles made from the Lyophilised Material, in each case, by Customer or its Affiliates; (b) Customer’s negligence or willful misconduct; (c) any breach by Customer of the Contract, including any breach of its representations, warranties, or obligations hereunder; or (d) NEB Lyo Sciences’ use or possession of the Customer Material or any third-party materials acquired by NEB Lyo Sciences’ at Customer’s request in performance of the Services.

6.3 Limitations on Liability. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, NEITHER NEB LYO SCIENCES NOR ITS AFFILIATES WILL BE LIABLE UNDER ANY LEGAL THEORY (INCLUDING BUT NOT LIMITED TO CONTRACT, NEGLIGENCE, STRICT LIABILITY IN TORT OR WARRANTY OF ANY KIND) FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, MULTIPLE, EXEMPLARY OR CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO COSTS OF COVER, LOST PROFITS, LOST DATA, LOSS OF BUSINESS, LOSS OF GOODWILL OR LOSS OF REVENUE) THAT CUSTOMER MIGHT INCUR UNDER THE CONTRACT, OR THAT MAY ARISE FROM OR IN CONNECTION WITH THE SERVICES, THE LYOPHILISED MATERIAL, OR NEB LYO SCIENCES’ PERFORMANCE HEREUNDER, EVEN IF NEB LYO SCIENCES HAD NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. IN ADDITION, NEB LYO SCIENCES’ AND ITS AFFILIATES’ MAXIMUM AGGREGATE LIABILITY ARISING OUT OF OR IN CONNECTION WITH THE CONTRACT, THE SERVICES, ANY LYOPHILISED MATERIAL, OR NEB LYO SCIENCES’ PERFORMANCE HEREUNDER IS LIMITED TO THE AMOUNT CUSTOMER PAID TO NEB LYO SCIENCES UNDER THE CONTRACT.

6.4 Competitive Work. Customer acknowledges that NEB Lyo Sciences and/or its Affiliates may at any time have, develop, use or acquire from third-parties material, assets, programs and/or information that are similar to or competitive with Customer Material or with Customer assets, programs, information and/or activities.

6.5 Term. The Contract shall commence on the Effective Date and shall remain in effect until the earlier to occur of (a) NEB Lyo Sciences completing the Services described in the Quote, including the last phase described therein, if any, and (b) the date that is three (3) months after the date of the most recent purchase order or other written request for Services submitted by Customer to NEB Lyo Sciences. Notwithstanding any other provision herein to the contrary, either Party may terminate the Contract at any time upon thirty (30) days’ prior written notice to the other Party. Upon any termination or expiration of the Contract, Customer shall pay NEB Lyo Sciences in accordance with clause 4 of these Terms for all Services performed up to the date of such termination or expiration and, if applicable, for any outstanding Additional Charges payable under clause 4. The following clauses, as well as any rights, obligations and duties which by their nature extend beyond the expiration or termination of the Contract, shall survive the expiration or termination of the Contract: clauses 1, 2.2, 3.1-3.4, 4, 5, and 6.

6.6 Conflicts. No terms contained in any standard form purchase order, order acknowledgment, invoice, Customer Material warranty literature or Customer Material manuals, or any other standardized form or document will be construed to amend or modify the terms of the Contract, and in the event of any conflict, the Contract will control. Subject to clauses 3.2(d) and 5.2, in the event of a conflict between (a) the Terms and a Quote, the Quote will take precedence, and (b) a written contract signed by both Customer and NEB Lyo Sciences covering the same subject matter as set forth herein and any Quote or these Terms, such written contract will take precedence over both the Quote and these Terms.

6.7 Export Control; Anticorruption Compliance. Customer acknowledges that the Lyophilised Material may be subject to export and re-export restrictions imposed by United Kingdom (“U.K.”), United States of America (“U.S.”), or other countries’ laws. Customer represents and warrants to NEB Lyo Sciences that it will not, directly or indirectly, (i) sell, export, reexport, transfer, divert, or otherwise dispose of any goods (including Lyophilised Material), software, or technology (including goods or products derived from or based on such technology) received from NEB Lyo Sciences to any destination, entity, or person prohibited by the laws of the U.K. or the U.S., or resell them to a purchaser whom it knows (or has reasonable grounds to suspect) will sell, export, reexport, transfer, divert, or otherwise dispose of them to such destination, entity, or person, or (ii) use the Lyophilised Material for any use prohibited by the laws or regulations of the U.K. or the U.S. and/or Customer’s local jurisdiction, without obtaining prior authorization from the competent government authorities as required by those laws and regulations. Customer represents and warrants that it will comply with all applicable laws and regulations relating to bribery and corruption, including but not limited to the U.K. Bribery Act and the U.S. Foreign Corrupt Practices Act. Without limiting the generality of the foregoing, Customer represents and warrants that it will not pay money or provide anything of value to any government official in violation of bribery or corruption laws or regulations applicable to its business activity.

6.8 Miscellaneous. The Contract will not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, except that NEB Lyo Sciences may assign the Contract to an Affiliate or to a successor in connection with the merger, consolidation or sale of all or substantially all of its assets or that portion of its business to which the Contract relates. It is expressly agreed that the Parties will be independent contractors and that the relationship between the Parties will not constitute a partnership, joint venture or agency. Neither Party will have the authority to make any statements, representations or commitments of any kind, or to take any action, which will be binding on the other without the prior written consent of the other Party to do so. Each Party will obtain prior written permission from the other before using the name, symbols and/or marks of the other in any form of publicity. The place of performance of the Contract is England and its conduct and interpretation and all disputes arising out of or in connection with it will be governed by the laws of England and Wales. Any such dispute will be subject to the exclusive jurisdiction of the English courts, provided that NEB Lyo Sciences may apply for an injunction or other interim relief and enforce a judgment awarded it by the English courts in any court of competent jurisdiction. The Contract constitutes the entire understanding of the Parties hereto and supersedes all prior agreements, written or oral, with respect to the subject matter hereof; provided, however, the Contract will not amend, diminish, supplement or otherwise affect any previous agreements, if any, between the Parties to the extent specifically related to the disclosure or use of confidential information covered by such prior agreements. The Contract may be changed only by a writing signed by both Parties and will be binding and inure to the benefit of the Parties’ respective successors and permitted assigns. Any notice required or permitted under the Contract will be in writing delivered personally or by facsimile (and promptly confirmed by personal delivery or courier), by overnight delivery by a nationally recognized courier service (with evidence of delivery) or by first class mail, postage prepaid (where applicable), effective upon receipt, addressed to the Party at such address as such Party has last furnished in writing to the other Party. The headings of the several clauses hereof are not a part of the Contract, but are merely guides or labels to assist in locating and reading the several clauses hereof. NEB Lyo Sciences reserves the right to change these Terms at any time. Any changes made to these Terms will not apply to any Contract between Customer and NEB Lyo Sciences in effect before the changes are made.