BIOPRODUCTION PRODUCT AND SERVICES TERMS AND CONDITIONS OF SALE

Thank you for your interest in purchasing Bioproduction Products and/or Services (defined below). We value your business and our goal is to make your purchasing experience as smooth as possible. If you have any questions about our quotation or ordering process, please call Customer Services at 1-435-792-8500. Unless otherwise expressly agreed in writing, your purchase of Bioproduction Products and/or Services is subject to the following Terms and Conditions (“Terms”).

1. Contract Terms

1.1 General Terms.
These Terms, our quotation, if any, and Supplementary Terms (defined below), if any, comprise the agreement (“Agreement”) between you and one or more Thermo Fisher Scientific Inc. affiliates, including Life Technologies Corporation; Life Technologies Limited; Advanced Scientifics, Incorporated; Doe & Ingalls Management, LLC; Doe & Ingalls Ltd.; Finesse Solutions, Inc.; Life Technologies BPD UK Limited; and/or Avances Cientificos de Mexico, S. de R.L. de C.V (individually, and collectively, referred to herein as “Thermo Fisher”, “us”, “we”, or “our”). Unless your order is subject to a valid, written, executed agreement between you and Thermo Fisher, in which case such agreement applies, you agree to accept and be bound by these Terms by ordering Bioproduction Products (including any related Services) on thermofisher.com or otherwise via Thermo Fisher when you receive ordering or sales documents that reference these Terms. This Agreement is the complete and exclusive contract between you and us with respect to your purchase and our sale of the Bioproduction Products and/or Services.

1.2 Supplementary Terms.
Some of our Bioproduction Products are subject to software licenses, limited use label licenses or other written contract terms that you will not find here (“Supplementary Terms”). You might find Supplementary Terms in our Documentation (defined below). You may also obtain copies from Customer Services.

1.3 Terms Conflict.
If any conditions within the Agreement documents conflict with each other, we will give them the following priority: our quotation, Supplementary Terms, and finally these Terms. We expressly reject any different terms or provisions contained in any document you provide, and if the terms and conditions in this Agreement differ from the terms of your offer, this Agreement will serve as the governing terms for our contract.

1.3 Terms Conflict.
If any conditions within the Agreement documents conflict with each other, we will give them the following priority: our quotation, Supplementary Terms, and finally these Terms. We expressly reject any different terms or provisions contained in any document you provide, and if the terms and conditions in this Agreement differ from the terms of your offer, this Agreement will serve as the governing terms for our contract.

1.4 When Agreement Takes Effect.
The Agreement between you and us is created when we accept your order, either by sending a written confirmation, or by shipping the Bioproduction Product or otherwise initiating action to provide what you have ordered or the Services. We reserve the right to change these Terms and the Supplementary Terms at any time, and any changes we make to these Terms will apply to the Agreement between us for any order we receive after the changes are made.

1.5 Agreement Defined Terms.
Capitalized terms used herein have the following definitions:
“Additional Rights” means third party intellectual property rights, or other rights from us such as commercial use rights or intellectual property rights, to use Bioproduction Products or Deliverables beyond that described in the Supplementary Terms.

“Binding Forecast” means a written 6 month forecast for Consumables submitted by you to us as part of the Forward PO, which once confirmed in writing by us becomes binding on the parties.

“Bioproduction Product(s)” means, generally, individually, and collectively, Equipment and/or Consumables.

“Confirmation” means our written confirmation of your participation in the Forward PO program for the Consumables listed in the Forward PO and which are part of the Binding Forecast.

“Consumable(s)” means consumable Bioproduction Products used in bioproduction processes, including but not limited to: cell culture media; sera; reagents; buffers; process liquids; chemicals, compounds, supplements; single-use flexible and rigid fluid containment systems for bioprocessing and liquid handling, including system components such as containers, bags, liners, ports, tubing, fittings, manifolds, filters, sensors and end treatments; contaminant and impurity detection, quantitation, and identification products; protein characterization products; affinity ligands; and chromatography resins, provided by us to you.

“Custom” means customized or special Bioproduction Products and/or Services that are manufactured or performed to written instructions, specifications or designs agreed to in writing by you and us.

“Deliverables” means the written results of the Services performed by us for you.

“Documentation” means labels affixed to Bioproduction Products or packaging; documentation, specifications, limited use label licenses and/or accompanying package inserts shipped with Bioproduction Products or Deliverables; certificates of analysis or conformation made available for Bioproduction Product; and/or documentation, specifications, use guidelines or instructions available in our catalogs or on our website for the applicable Bioproduction Product.

“Equipment” means durable bioproduction and bioprocess liquid handling instruments and equipment including but not limited to bins, vessels, single-use bioreactors, single-use mixers, single-use fermentors, and related controllers and software provided by us to you. “Forward PO” means a binding forward purchase order submitted by you to us in order to obtain continuity of supply for Consumables.

“Service(s)” means services, analysis, or studies provided by us to you related to the form, fit and/or function of Bioproduction Products, including, but not limited to, those under the title Stability Studies, Factory Acceptance Testing Services, Site Acceptance Testing Services (or any combination thereof), as well as related to the procurements, storage, distribution, marketing and sale of chemicals and other Consumables. "Services" excludes media or cell line development services, media or cell line optimization services, and any services where the deliverables include biological materials - which such services must be provided under a separate mutually executed agreement between you and us.

"SKU Number" means our stock-keeping unit, part number, or product identification number assigned to the Bioproduction Product or Service or the raw materials or components associated with the Bioproduction Product in our business systems. “SOW” means written study or testing protocols and/or statement(s) of work mutually agreed upon between the parties.

“Specifications” means our current, documented specifications or designs for Bioproduction Products or Services in effect at the time of order confirmation; or in the case of Custom Bioproduction Products, Specified Components or Custom Services, “Specifications” means the mutually agreed upon written specifications or designs for such Custom Bioproduction Products, Specified Components or the mutually agreed to quote or SOW for such Custom Services.

“Specified Components” means specified raw materials, components, sources, brands or suppliers requested by you to be used in the manufacture or assembly of Custom Bioproduction Products or the performance of Services and includes Consumables and other products and substances manufactured or supplied by third parties, including those products that you purchase through any of our sales channels or affiliates.

2. Price

2.1 Determining Price.
We may change our prices at any time without notice. Prices we quote you are valid for 30 days, unless we state otherwise in writing. Additionally, the price as shown in our quotation to you, is subject to adjustment on account of any change to specifications, quantities, raw materials, cost of production, shipment arrangements, currency exchange or terms or conditions which are not part of our original price quotation. If no price has been specified or quoted to you, the price will be the Bioproduction Product or Service price on thermofisher.com in effect at the time we accept your order.

2.2 Taxes and Fees.
Our Bioproduction Product and/or Service prices do not include any taxes (including VAT), duties, levies or other government fees that may apply to your order. If they apply, it will be your responsibility to pay them. If we pay them, we will add them to your invoice. If you claim any exemption, you must provide a valid, signed certificate or letter of exemption for each respective jurisdiction.

2.3 Delivery Fees; Freight Policy.
You are also responsible for standard delivery, insurance, and handling charges, if any. We will also add these charges to your invoice. For details of our freight policy, please call Customer Services.

3. Payment

3.1 Payment Terms.
We will invoice you for the Bioproduction Product price and all other charges due when we ship you the Bioproduction Products or within 30 days after we begin performing the Services (unless otherwise agreed in writing). Unless we have agreed otherwise in writing, you will pay us within 30 days from our invoice date. Each order is a separate transaction, and you may not off-set payments from one order against another. We reserve the right to require you to make full or partial payment in advance, or other security to our satisfaction, if we believe in good faith that your financial condition does not justify the payments terms otherwise specified. You will make all payments in U.S. Dollars.

3.2 Late Payment.
If you are late in making payment, we may, without affecting our other rights:

  • (A) suspend delivery or cancel the Agreement;
  • (B) reject your future orders; and/or
  • (C) charge you a late-payment charge, from the due date until paid, at the rate of 1.5% per month, or, if less, the maximum amount allowed by law - which you must pay upon our demand.

3.3 Collection Costs.
If we appoint a collection agency or an attorney to recover any unpaid amounts, you must pay all reasonable costs of collection, including all associated reasonable attorneys’ fees.

4. Delivery; Cancellation; Changes; Forward PO; Storage

4.1 Delivery.
We will ship Bioproduction Products to the U.S. destination you specify in your order FOB our shipping point (Incoterms 2010), and free carrier (FCA) place of shipment (Incoterms 2010) for destinations outside the U.S, with packaging and carriers as designated by Thermo Fisher, unless otherwise specified in an accepted order. We may, in our discretion, (a) make partial shipments and invoice each shipment separately; and/or (b) stop delivery of Services or Bioproduction Products in transit and withhold shipments in whole or in part if you do not pay us when due, or if you otherwise do not perform your obligations in this Agreement. Our shipping or performance dates are approximate only, and we will not be liable for any loss or damage resulting from any delay in delivery or failure to deliver which is due to any cause beyond our reasonable control. If we do delay shipment or performance because of a cause beyond our reasonable control, we may terminate the affected order, or reschedule the shipment, and we will do so within a reasonable period of time. You may not refuse delivery or otherwise be relieved of any obligations as the result of such delay. If our delivery of a Bioproduction Product to you is delayed due to any cause within your control, we will place the delayed Bioproduction Products in storage at your risk and expense and for your account.

4.2 Cancellation.
Once you have placed your order, you cannot cancel it, unless we consent in writing, and you agree to pay any applicable cancellation charges.

4.3 Changes.
You may not change orders in process, except with our written consent and agreement as to an appropriate adjustment in the purchase price for the applicable Bioproduction Products or Services. You will not receive credit for Bioproduction Products returned without our prior consent.

4.4 Consumables Forward PO Program.
If you desire to participate in Thermo Fisher’s Consumables Forward PO program, you will submit a Binding Forecast, which once we issue a Confirmation becomes binding on the parties. The Confirmation will contain the SKU Numbers for the raw materials or components to be used in the production of the Bioproduction Products in the Binding Forecast, and the price or quotation reference. You will have 2 business days from the date of the Confirmation to cancel or make modifications to the Confirmation in writing. If you do not cancel or make modifications to the Confirmation in writing, the Confirmation will be binding on both parties. You will then submit a Forward PO for the Consumables in the Binding Forecast. Upon submission of the Forward PO we will proceed to purchase the raw materials described in the Confirmation or as otherwise required and produce such Bioproduction Products according to the Specifications. We may deliver the Bioproduction Products up to 4 weeks prior to the originally requested delivery date described in the Binding Forecast upon written request by you and with confirmation by us. We will accept multiple release shipments against the Binding Forecast and will invoice each shipment separately. Upon the expiration of the Binding Forecast, any remaining Bioproduction Products produced but not yet shipped under the Binding Forecast will be shipped to you and invoiced, and if such Bioproduction Products have not been produced, we may invoice you for the burdened cost of raw materials described in the Confirmation or as otherwise required but not yet used in manufacture of the Bioproduction Products.

4.5 Storage; Fees.
If you fail to take delivery of the Bioproduction Products pursuant to your order or according to the Binding Forecast schedule, we may provide storage and assess storage fees for raw materials and finished Bioproduction Products that are held at Thermo Fisher facilities past the original requested delivery date. If you still have not taken delivery of the raw materials and finished Bioproduction Products three (3) months past the original requested delivery date, unless we agree in a signed writing to continue to hold the raw materials and finished Bioproduction Products for additional storage fees and an excess inventory fee which we will invoice you for and you will pay to us, we will ship the raw materials and finished Bioproduction Products to you and invoice you for them.

5. Risk of Loss and Title

5.1 Risk of Loss.
Regardless of any trade terms indicated above and subject to our right to stop delivery of Bioproduction Products in transit, Bioproduction Products are delivered when we load them onto the commercial carrier at our facility. At this point you become responsible for risk of loss and damage. We do not clear Bioproduction Products for import into your country and doing so is your responsibility.

5.2 Title.
Title to Bioproduction Products will pass to you (except software incorporated within or forming part of a Bioproduction Product, which we or our licensors continue to own) when we deliver the Bioproduction Product to the carrier.

6. Bioproduction Product Returns and Shortages

6.1 Returns and Shortages.
We want you to receive our Bioproduction Products in good condition. You may return a Bioproduction Product that is damaged or defective on delivery, or correct any shortages, if you contact Customer Services within 5 days after receiving the Bioproduction Product. If you do not contact us within this 5-day period, we will deem the Bioproduction Product accepted, but you will not waive the warranties described in Section 7 below.

6.2 Authorization for Returns.
Customer Services must authorize all Bioproduction Product returns. If your Bioproduction Product return is authorized, Customer Services will provide you directions regarding the return process. Customer Services may not authorize some Bioproduction Products for return.

6.3 Bioproduction Product Credit Eligibility.
To be eligible for Bioproduction Product credit, a Bioproduction Product authorized for return must arrive at our facilities in a condition satisfactory for resale. At our discretion or unless as otherwise agreed, any return not due to our error is subject to a restocking charge up to the value of the returned Bioproduction Product. We do not credit shipping charges. You may not return a Bioproduction Product for credit more than 20 days after you receive it.

6.4 Custom Bioproduction Product and Specified Components Returns.
You may return a Custom Bioproduction Product or Specified Components we make or sell to you only if the Bioproduction Product does not conform to the Specifications as of the date of shipment. In that case, we will, in our sole discretion, either replace the non-conforming Custom Bioproduction Product or Specified Components or provide a credit for the purchase price for the non-conforming Custom Bioproduction Product or Specified Components.

7. Warranties

7.1 Limited Warranty for Bioproduction Products and Services.
Bioproduction Products will be shipped to you in conformance with the Specifications and with good title. Services will be provided for you in conformance with the quote or SOW. You will have the earliest to occur of: the end of the shelf life, the expiry date, or 1 year from the date of shipment for Bioproduction Products, and 1 year from the date of performance for Services, to submit a warranty claim as provided in Section 7.5.

7.2 Limited Warranty for Spare Parts.
We also warrant that spare parts you purchase from us and that we install, or are installed by a company we have certified as an authorized installer, will be shipped in conformance with the Specifications. You will have 3 months from the date we deliver the spare parts to you, or, if longer, the original warranty period of the Equipment in which the part is installed to submit a warranty claim for the spare part(s). We do not warrant parts that you do not purchase from us or we do not install. Spare parts are sold “as is”.

7.3 Exclusions.
In addition to our exclusion for third party products as set out in Section 7.6, our warranties for Bioproduction Products do not apply to (a) normal wear and tear; (b) accident, disaster or event of force majeure; (c) your misuse, fault or negligence; (d) use of the Bioproduction Products in a manner for which they were not designed; (e) causes external to the Bioproduction Products such as, but not limited to, external puncturing, power failure or electrical power surges; (f) improper storage and handling of the Bioproduction Products; (g) use of the Bioproduction Products in combination with equipment or software that we did not supply; (h) Equipment sold to you as ’used’ products; (i) contact with improperly used or unapproved chemicals or samples; (j) installation, removal, use, maintenance, storage, or handling in an improper, inadequate, or unapproved manner, such as, but not limited to, failure to follow the Documentation or instructions in Deliverables, operation outside of stated environmental or other Specifications, or operation with unapproved software, materials or other products; (k) manufacture in accordance with requirements you gave us; (l) installation of software or interfacing, or use of the Equipment in combination with software or products we have not approved; (m) use of the Deliverables or any Documentation to support any regulatory approvals; (n) the performance, efficacy or compatibility of Specified Components; and (o) the performance of Custom Bioproduction Products, Specified Components or achievement of any results from Bioproduction Products, Specified Components or the Services within ranges desired by you, (e.g. pH level for media, or achievement of a specified titer), even if those ranges are communicated to us and are described in Specifications, a quote, or a SOW. ADDITIONALLY, ANY INSTALLATION, MAINTENANCE, REPAIR, SERVICE, RELOCATION OR ALTERATION TO OR OF, OR OTHER TAMPERING WITH, THE BIOPRODUCTION PRODUCTS PERFORMED BY ANY PERSON OR ENTITY OTHER THAN US WITHOUT OUR PRIOR WRITTEN APPROVAL, OR ANY USE OF REPLACEMENT PARTS WE HAVE NOT SUPPLIED, WILL IMMEDIATELY VOID AND CANCEL ALL WARRANTIES WITH RESPECT TO THE AFFECTED BIOPRODUCTION PRODUCTS. WE MAY ALSO VOID YOUR WARRANTY IF YOU SHIP THE BIOPRODUCTION PRODUCT OUTSIDE OF THE UNITED STATES.

If we determine that Bioproduction Products for which you requested warranty services are not covered by the warranty, you will pay or reimburse us for all costs of investigating and responding to such request at our then prevailing time and materials rates. If we provide repair services or replacement parts that are not covered by this warranty, you will pay us at our then prevailing time and materials rates. You must pay for all manufactured lots of Custom Bioproduction Products so long as they comply with the Specifications, even if the Custom Bioproduction Products do not perform to your expectations in your own applications.

7.4 Limitations.
OUR WARRANTIES EXTEND ONLY TO YOU, THE ORIGINAL PURCHASER AND YOU CANNOT TRANSFER THEM. OUR OBLIGATION TO REPAIR OR REPLACE A BIOPRODUCTION PRODUCT, OR RE-PERFORM THE SERVICES, IS YOUR SOLE REMEDY. EXCEPT FOR THE WARRANTIES DESCRIBED IN THESE TERMS, WE DISCLAIM ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO THE BIOPRODUCTION PRODUCTS, DELIVERABLES, DOCUMENTATION OR SERVICES, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR ANY PARTICULAR PURPOSE. WE DO NOT WARRANT THAT THE BIOPRODUCTION PRODUCTS, DELIVERABLES, DOCUMENTATION OR SERVICES ARE ERROR-FREE OR WILL ACCOMPLISH ANY PARTICULAR RESULT.

7.5 Remedies.
During the applicable warranty period only, for Bioproduction Products or Services not meeting our warranty, we agree, in our sole discretion, to repair or replace that portion of Bioproduction Product or Deliverables which do not conform to the Specifications, re-perform that portion of the Services so that they conform with the quote or SOW, and/or provide additional parts as reasonably necessary to comply with our warranty obligations, as applicable, but you must first (a) promptly notify us in writing when you discover any defect or non-conformance, and include in the notice the details of your warranty claim as requested by our Customer Services Dept.; and (b) after our review, assuming we authorize the Bioproduction Product return, we will provide you with service data and/or a Return Material Authorization (“RMA”), which may include biohazard decontamination procedures and other product-specific handling instructions that you must follow. You may be required to provide a sample of any claimed non-conforming Bioproduction Product. For valid product warranty claims timely made in accordance with these Terms, you may return the non-conforming Bioproduction Products to us and we will prepay the shipping costs. For non-conforming Equipment only, we may choose to provide you with new or refurbished replacement parts. For non-conforming Services only, we will re-perform the Services.

7.6 Specified Components.
We do not support or make any warranties about Specified Components. The provision and use of Specified Components may be governed by a third-party manufacturer’s own contract terms. You must look directly to the relevant third-party manufacturer for product support, warranties, and to make warranty claims concerning Specified Components. We agree, however, to assign to you any warranty rights we may have from the original manufacturer or third party supplier, concerning the Specified Components to the extent the original manufacturer or third party supplier allows. Custom Products or Custom Services which include Specified Components may be subject to price increases at any time, before or after the issuance of a quote due to changes in the Specified Component supplier’s prices. We will not be obligated to provide quantities of Custom Product or deliver Custom Services incorporating Specified Components due to a failure of such Specified Component suppliers. You represent and warrant that the inclusion of the Specified Component in a Custom Product, use with a Bioproduction Product, or use as part of Custom Services, will not infringe any third parties’ rights, and you will indemnify and hold us harmless from any such third party claims.

8. Indemnification

8.1 Our Indemnity.

    • (A) Our General Indemnity. We will defend and indemnify you against third-party claims for injury to persons, including death, or damage to tangible property occurring while our employees are on your premises performing Services, to the extent the claims are caused by our employees’ negligent acts or negligent omissions, except to the extent caused by your negligent acts or negligent omissions.
    • (B) Our Infringement Indemnity. We will defend and indemnify you against infringement damages finally awarded in any legal action brought by a third party against you to the extent that the action is based on a claim that our manufacture and sale of a Bioproduction Product infringes any patent, copyright, trademark or other intellectual property right of such third party if we had actual knowledge of such intellectual property right and the actual infringement at the time of delivery of the Bioproduction Product to you. This infringement indemnity does not apply to claims that arose based on (a) your failure to comply with the Agreement; (b) your failure to acquire any applicable Additional Rights; (c) Bioproduction Products that we made, assembled or labeled in reliance upon your instructions, specifications, other directions, Custom Specifications, or Specified Components; (d) your use or resale of Bioproduction Products, (e) modifications made by you or any third party; or (f) Bioproduction Products originating from third parties.

      Additionally, our infringement related indemnity obligations will be extinguished if we, at our option and expense, either: (a) secure for you the right to continue using the Bioproduction Product; (b) substitute the Bioproduction Product with another suitable product with similar functionality; or (c) in the event (a) and (b) are not practical, refund to you the amortized amounts you paid for the infringing Bioproduction Product, based on a 5-year amortization schedule.

      THIS INDEMNITY IS OUR ONLY LIABILITY TO YOU, AND YOUR ONLY REMEDY, FOR ANY INFRINGEMENT OR CLAIMED INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS BY OR INCONNECTION WITH ANY BIOPRODUCTION PRODUCT.

    • (C) Conditions to Our Indemnity. As a condition to any of our indemnification obligations you must (a) notify us in writing, as soon as you become aware of any claim; (b) not admit any liability or take any other action in connection with the claim that could affect the defense; (c) allow us to solely control the defense or settlement of the claim; and (d) give us your reasonable information, co-operation and assistance.

8.2 Your Indemnity.
You will indemnify, defend with competent and experienced counsel and hold us, including our parent, subsidiaries, affiliates and divisions, and their respective officers, directors, shareholders and employees, harmless from and against any and all damages, liabilities, actions, causes of action, suits, claims, demands, losses, costs and expenses (including without limitation reasonable attorneys' fees and disbursements and court costs) suffered by any of the foregoing entities or individuals to the extent arising from or in connection with (a) your or your agents’, employees’, representatives’ or contractors’ negligence or willful misconduct; (b) your use of a Bioproduction Product, Deliverable or Service (including, without limitation, in combination with equipment or software we did not supply you, or in an application or environment for which it was not designed); (c) our manufacture of Custom Bioproduction Products and/or our use of Specified Components;; (d) your, your employees’ or your agent’s export, import or re-export of any Bioproduction Products or Deliverables, including without limitation, in violation of Section 14 below; and (e) your failure to acquire any applicable Additional Rights.

9. Software

9.1 Definitions.
With respect to any software products incorporated in or forming a part of our Bioproduction Products, you understand and agree that we are licensing such software products and not selling them, and that the words "purchase", "sell" or similar or derivative words are understood and agreed to mean "license", and that the word "you" is understood and agreed to mean "licensee". We, or our licensor, as applicable, retain all rights and interest in software products we provide you.

9.2 License.
We hereby grant to you a royalty-free, non-exclusive, nontransferable license, without power to sublicense, to use software we provide you under this Agreement solely for your own internal business purposes on the Equipment we provide you hereunder, and to use the related documentation solely for your own internal business purposes. This license terminates when your lawful possession of the Equipment provided hereunder ceases, unless earlier terminated as provided in this Agreement.

9.3 Restrictions.
You agree to hold in confidence and not to sell, transfer, license, loan or otherwise make available in any form to third parties the software products and related documentation provided hereunder. You may not disassemble, decompile or reverse engineer, copy, modify, enhance or otherwise change or supplement the software products provided hereunder without our prior written consent. We will be entitled to terminate this license if you fail to comply with any term or condition herein.

9.4 Return of Software and Documentation.
You agree, upon termination of this license, immediately to return to us all software products and related documentation provided hereunder and all copies and portions thereof.

9.5 Third Party Software.
Our warranty and indemnification provisions set forth in this Agreement will not apply to third party owned software products we provide you.

10. Intellectual Property

10.1 Limitation of Rights.
As between you and us, we exclusively own all intellectual property rights relating to our Bioproduction Products, Services, Documentation and Deliverables. Unless we expressly state otherwise in Supplementary Terms, our selling Bioproduction Products to you grants you only a limited, nontransferable right under our intellectual property. Only you may use the Bioproduction Products or Deliverables you have bought from us, and only for your internal research or further manufacturing purposes in accordance with Section 16.3. No right to transfer, distribute or resell our Bioproduction Products, Documentation or Deliverables or any components of the foregoing is conveyed expressly, by implication, or by estoppel. Unless expressly permitted by us in writing, you will not modify, change, remove, cover or otherwise obscure any of our or our affiliates’ brands, trade or service marks on the Bioproduction Products, Documentation or Deliverables. Nothing in the Agreement limits our ability to enforce our intellectual property rights.

10.2 Commercial Applications; Additional Rights.
Unless we expressly state otherwise in Supplementary Terms, we give no rights to use our Bioproduction Products or Deliverables for commercial purposes such as resale, distribution or reporting the results of your activities for a fee or other consideration. If you desire to use Bioproduction Products or Deliverables for commercial purposes, please contact our out-licensing department at outlicensing@thermofisher.com. Where your use of Bioproduction Products or Deliverables is outside the scope of the Agreement, it is solely your responsibility to acquire Additional Rights from us and third parties related to such use.

10.3 Intellectual Property Ownership.
We exclusively own all intellectual-property rights in any inventions (patentable or otherwise), discoveries, improvements, data, know-how, or other results that are conceived, developed, discovered, reduced to practice, or generated by or for us, or jointly by you and us, in relation to processes, methods, or related synthesis of a Bioproduction Product or Service, or otherwise in connection with designing or manufacturing a Bioproduction Product or performing a Service. You hereby transfer and assign to us all your right, title, and interest in and to any such intellectual property, and at our request and at our expense, you will help us secure and record our rights in the intellectual property.

11. Custom Products and Specified Components

11.1 Declining to Make or Deliver.
If you ask us to manufacture a Custom Bioproduction Product, we may decline to design or manufacture such Bioproduction Product—at any stage of the process - if such Bioproduction Product is unsuitable or commercially impractical to be synthesized in the way you specified. If so, we will notify you, and you will not be obligated to pay any fees for any expenses we incurred in connection with the declined Custom Bioproduction Product. If a Specified Component fails, or is delayed in delivery, we may delay or cancel the Custom Bioproduction Product’s or Specified Component’s delivery without liability to us.

11.2 Your Responsibilities.
By submitting an order for a Custom Bioproduction Product or Specified Component, you represent and agree that you:

  • (A) have given us all information you know of regarding any biological, radiological, and chemical hazards associated with the handling, transport, exposure to, or other use of the materials you supply to us or any Specified Components; and
  • (B) have the right, including but not limited to any necessary intellectual property rights, to allow us to manufacture the requested Custom Bioproduction Product, use the Specified Component, provide the Service, or provide the Deliverable.

11.3 No Exclusivity.
You acknowledge and agree that Thermo Fisher is in the business of manufacturing catalog and custom products for the bioproduction, bioprocessing, and biomanufacturing industries, as well as providing related development, consulting and custom manufacturing services. Nothing in the Agreement prohibits us, independently or in collaboration with third parties, from developing items, goods, materials, samples, information and/or data similar or identical to the Bioproduction Products, Services, Custom Bioproduction Products, Custom Services, or Deliverables we provide to you.

12. Services; Equipment-Related Services and Installation

12.1 Services.
These Terms apply to the provision of the Services described in any quote and/or SOW. If you desire to obtain Services from us and if we, in our sole discretion, are willing to consider the same, then we will prepare a written quote and/or SOW for such Services. Any change to Specifications in the quote or SOW may mean a price change. Orders for Services may not be cancelled after 48 hours of order placement. Unless otherwise specified, Services are not performed under cGMP or regulated conditions and Deliverables are not intended to be used in any regulatory filings or to support regulatory approvals. You must pay for all Services performed so long as they are performed in material compliance with the Specifications in the quote or SOW agreed upon by you. We have no obligation to perform Services after the expiration of a written quotation.

12.2 Equipment-Related Services.
When you purchase Equipment, we may provide Services as described in a SOW. We also offer annual Equipment Service plans. For full details of our Equipment Service plans, please contact Customer Services.

12.3 Equipment-Related Service and Installation Restrictions.
If we provide Equipment Services at your premises, it is your responsibility to ensure that the workplace where the Equipment is to be located and/or Services are to be performed is safe. It is also your responsibility to move the Equipment (uncrated) to the installation location, and/or onto any tabletop where it will be installed, as applicable, to avoid any additional handling. We do not install Equipment or perform Services in biosafety-level-3 laboratories, unless you and we agree otherwise in writing in advance. Under no circumstances do we install Equipment or perform Services in biosafety-level-4 laboratories.

13. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, WE WILL NOT BE LIABLE UNDER ANY LEGAL THEORY (INCLUDING BUT NOT LIMITED TO CONTRACT, NEGLIGENCE, STRICT LIABILITY IN TORT OR OTHERWISE, BUT EXCLUDING BREACH OF WARRANTY (THE SOLE REMEDY FOR WHICH WILL BE AS PROVIDED IN SECTION 7.5 ABOVE) 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 YOU MIGHT INCUR UNDER THE AGREEMENT, OR THAT MAY ARISE FROM OR IN CONNECTION WITH OUR BIOPRODUCTION PRODUCTS OR SERVICES, EVEN IF WE HAD NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. IN ADDITION, OUR MAXIMUM AGGREGATE LIABILITY ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT, OR ANY BIOPRODUCTION PRODUCT OR SERVICE, IS LIMITED TO THE AMOUNT YOU PAID TO US FOR THE SPECIFIC BIOPRODUCTION PRODUCT OR SERVICE PURCHASED GIVING RISE TO THE LIABILITY. HOWEVER, THESE PROVISIONS DO NOT LIMIT OUR LIABILITY FOR DEATH OR PERSONAL INJURY CAUSED BY OUR NEGLIGENCE OR FRAUD, FRAUDULENT MISREPRESENTATION OR ANY OTHER LIABILITY THAT CANNOT BE EXCLUDED BY LAW.

14. Export Restrictions

14.1 Items.
You acknowledge that each Bioproduction Product, related software, Deliverable, Documentation and related technology, data or information (individually and collectively “Items”), is subject to U.S. government export controls.

14.2 Export Controls.
The export controls may include, among others, those of the Export Administration Regulations of the U.S. Department of Commerce (the “EAR”), which may restrict or require licenses for the export of Items from the United States and their re-export from other countries.

14.3 Compliance Requirements.
You and we may be required to obtain a license, prior to shipment, from one or more regulatory agencies in order to provide the Items to your delivery address. You must comply with the EAR and all other applicable laws, regulations, laws, treaties, and agreements relating to the export, re-export, and import of any Item. You must not, without first obtaining the required license to do so from the appropriate U.S. government agency; (a) export or re-export any Item, or (b) export, re-export, distribute or supply any Item to any restricted or embargoed country or to a person or entity whose privilege to participate in exports has been denied or restricted by the U.S. government. You will, if we request, provide information on the end user and end use of any Item you export or plan to export, as well as written assurance(s) of compliance with EAR in the form we specify either prior to shipment/delivery of Items and/or upon our request.

14.4 Audit Cooperation.
You will cooperate fully with us in any official or unofficial audit or inspection related to applicable export or import control laws or regulations.

15. Medicare/Medicaid Reporting Requirements

If you are a recipient of Medicare/Medicaid funds, you acknowledge and agree that:

  • (A) you have been informed of and agree to fully and accurately account for, and report on your applicable cost report, the total value of any discount, rebate or other compensation paid hereunder in a way that complies with all applicable federal, state and local laws and regulations which establish "Safe Harbor" for discounts.
  • (B) you will make a written request to us in the event that you require additional information from us in order to meet your reporting requirements.
  • (C) your agreement to comply with such reporting requirements was a condition precedent to our agreement to provide Bioproduction Products and/or Services and that we would not have entered into this Agreement had you not agreed.

16. Miscellaneous

16.1 No Assignment.
You may not delegate any duties nor assign any rights or claims hereunder without our prior written consent, and any such attempted delegation or assignment will be void.

16.2 Governing Law.
The Agreement and performance under it will be governed by Delaware law, without reference to its choice of law provisions. In the event of any legal proceeding between you and us relating to the Agreement, neither party may claim the right to a trial by jury. Any action arising under the Agreement must be brought within 1 year from the date that the cause of action arose. The U.N. Convention on Contracts for the International Sale of Goods is hereby expressly excluded.

16.3 Use and Regulatory Restrictions.
You must use Bioproduction Products and Deliverables in accordance with our Documentation and, if applicable, other associated Supplementary Terms (including without limitation, a research use only product label or limited use label license). In the absence of any intended use statement in the Documentation or other Supplementary Terms associated with such Bioproduction Products, which will control, Bioproduction Products are intended for research use or further manufacturing in bioprocessing applications, and not for diagnostic use or direct administration into humans or animals, we do not submit Bioproduction Products for regulatory review by any governmental body or other organization, and we do not validate them for clinical or diagnostic use, for safety and effectiveness, or for any other specific use or application. You are solely responsible for making sure that the way you use our Bioproduction Products and/or Deliverables complies with applicable laws, regulations and governmental policies, and that Bioproduction Products and/or Deliverables are used by technically-qualified individuals. You must obtain all necessary approvals and permissions you may need. It is solely your responsibility to make sure the Bioproduction Products and/or Deliverables are suitable for your particular use.

16.4 Uncontrollable Circumstances.
We will not be responsible or liable for failing to perform our obligations under the Agreement to the extent caused by circumstances beyond our reasonable control. In certain situations, we may use our reasonable judgment and apportion Bioproduction Products and Services then available for delivery fairly among our customers.

16.5 No Waiver; Invalidity.
Our failure to exercise any rights under the Agreement is not a waiver of our rights to damages for your breach of the Agreement and is not a waiver of any subsequent breach. If any provision or part of the Agreement is found by any court of competent jurisdiction to be invalid or unenforceable, such invalidity or unenforceability will not affect the other provisions of the Agreement. No person other than you or us will have any rights under the Agreement.

16.6 Headings.
Headings are for convenience only and shall not be used in the interpretation of these Terms.

16.7 Confidentiality.
You agree to keep confidential any non-public technical information (including without limitation, formulations), commercial information (including without limitation, prices, supplier identities, terms) and/or instructions (including any gene sequences, oligo types or sequences) received from us as a result of discussions, negotiations and other communications between us in relation to our Bioproduction Products or Services.

16.8 Notices.
Any notice or communication required or permitted under these Terms must be in writing and will be deemed received when personally delivered, or 3 business days after being sent by certified mail, postage prepaid, to a party’s specified address.

16.9 Requirement to Reduce to Writing.
No waiver, consent, modification, amendment or changes to the Terms or the Agreement will be binding unless in writing and signed by both of us. Our failure to object to terms contained in any subsequent communication from you will not be a waiver or modification of the Agreement.

16.10 Use of Affiliates.
Thermo Fisher’s rights, duties and obligations under the Agreement, including but not limited to Bioproduction Product manufacture, shipment, invoicing, payment processing, or performance of Services, may be enforced or performed by any Thermo Fisher affiliate.