Document:

fmi-ex101_238.htm

Exhibit 10.1

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission 

Confidential Treatment Requested Under 

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Execution Version

 

AMENDED AND RESTATED SUPPLY, SERVICE, AND SUPPORT AGREEMENT

 

This Amended and Restated Supply, Service, and Support Agreement (this “Agreement”) is effective as of the date of last signature found below (the “Restatement Date”) between Illumina, Inc., a Delaware corporation having a place of business at 5200 Illumina Way, San Diego, CA  92122 (“Illumina”) and Foundation Medicine, Inc. (“FMI”) having a place of business at 150 Second Street, Cambridge, MA, 02141, on behalf of itself and its Ordering Affiliates (collectively, “Customer”), and amends and restates that certain Supply, Service, and Support Agreement dated July 25, 2013 (“Effective Date”) between Foundation Medicine, Inc. and Illumina, as amended (“Prior Agreement”).  Upon execution, the terms of this Agreement shall supersede and control over the terms of the Prior Agreement.  Customer and Illumina may be referred to herein as “Party” or “Parties.” 

 

The Parties agree as follows:

 

1.Definitions.  The following terms have these meanings.  

 

“Affiliate(s)” means with respect to a Party, any entity that, directly or indirectly, controls, is controlled by or is under common control with such Party for so long as such control exists.  For purposes of this definition, an entity has control of another entity if it has the direct or indirect ability or power to direct or cause the direction of management policies of such other entity or otherwise direct the affairs of such other entity, whether through ownership of the voting securities of such other entity, by contract or otherwise. For the avoidance of doubt, with respect to Customer the term “Affiliate” shall in no event include Roche Holding Ltd, Basel, Switzerland (“Roche”) or Chugai Pharmaceutical Co. Ltd., Tokyo, Japan (“Chugai”) and their respective subsidiaries, unless the Parties specifically memorialize such inclusion of Roche and/or Chugai and their respective subsidiaries in a signed written amendment to this Agreement. With respect to Illumina, the term “Affiliate” shall not include Helix Holdings I, LLC (“Helix”), or GRAIL, Inc., or their respective subsidiaries and members (other than Illumina). Additionally, each Party may exclude any entity that would otherwise qualify as an Affiliate pursuant to the above definition, in each case solely to the extent such entity has not participated and is not then participating in activities under this Agreement (including the grant of any intellectual property or other rights), by providing written notice to the other Party.

 

“Affiliate Application Specific IP” means the Intellectual Property Rights of an Affiliate of Illumina that pertain to the Product (and use thereof) only with regard to specific field(s) or specific application(s).  Affiliate Application Specific IP excludes all Core IP. By way of non-limiting example, Intellectual Property Rights for [...***...] are examples of Affiliate Application Specific IP.  Affiliate Application Specific IP is a subset of Application Specific IP. 

 

“Application Specific IP” means the Illumina Intellectual Property Rights, inclusive of Affiliate Application Specific IP, that pertain to the Product (and use thereof) only with regard to specific field(s) or specific application(s).  Application Specific IP excludes all Core IP.  By way of non-limiting example, Illumina Intellectual Property Rights for [...***...] are examples of Application Specific IP.   

 

“Base Price” means, on a Country-specific basis, with respect to

(x) any [...***...],

(i) for [...***...] of the Term after the Restatement Date, the lesser of (A) Illumina’s [...***...] for such [...***...] in the applicable Country [...***...], and (B) [...***...] in the applicable Country [...***...], as set forth in the relevant [...***...] Quote, and

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(ii) for [...***...] of the Term thereafter, the lesser of (A) [...***...] in the applicable Country [...***...], and (B) [...***...] in the applicable Country [...***...], as set forth in the relevant [...***...] Quote; and 

 (y) any [...***...], Illumina’s [...***...].

For the avoidance of doubt, Illumina’s [...***...].

 “Consumable(s)” means Illumina-Branded reagents and consumable items that are intended by Illumina for use with, and are to be consumed through the use of Illumina Hardware.  Consumables are either TG Consumables or Non-TG Consumables (including Temporary Consumables).  “TG Consumables,” which may also be referred to herein as “Advantage Consumables,” are designated with the pre-fix “TG” in their part number or product description, which prefix indicates that they have the attributes detailed in Sections 10-12.  “Non-TG Consumables,” which may also be referred to herein as “Non-Advantage Consumables,” are all Consumables other than TG Consumables and includes Replacement Non-TG Consumables.  All references in this Agreement to Consumables means both TG Consumables and Non-TG Consumables unless specified otherwise in this Agreement. 

 

“Consumable Kit(s)” means individual boxes containing TG Consumables.

 

“Core IP” means Illumina Intellectual Property Rights that pertain to or cover aspects or features of the Product (or use thereof) that are common to the Products in all applications and all fields of use. To avoid any doubt, and without limitation, Core IP specifically excludes any and all Intellectual Property Rights relating to [...***...].  

 

“Country” or “Countries” means in the case of 

	
 
	
(i)
	
Foundation Medicine, Inc.: the United States of America, including its territories and possessions, and

	
 
	
(ii)
	
FMI Germany GmbH: Germany

provided that this definition shall automatically be deemed to be updated to include the countries of formation or incorporation, as applicable, of FMI and each of its Affiliates listed on Exhibit B attached hereto, as may be updated by in a signed written amendment to this Agreement entered into by the Parties as contemplated in the definition of the term ‘Ordering Affiliates’.

 

“Customer Use” means use in the Field, specifically excluding any use that (i) is not in accordance with the Product’s Specifications or Documentation, (ii) requires grants of rights or a license to Application Specific IP or Affiliate Application Specific IP, (iii) is a re-use of a previously used Consumable, (iv) is the disassembling, reverse-engineering, reverse-compiling, or reverse-assembling of the Product, (v) is the separation, extraction, or isolation of components of Consumables or other unauthorized analysis of the Consumables, (vi) gains access to or determines the methods of operation of the Product, (vii) is the use of a non-Illumina reagent/consumable with Illumina Hardware (unless the Specifications or Documentation state otherwise), or (viii) is the transfer to a third party of, or sub-licensing of, Software or third-party software.

 

 “Documentation” means Illumina’s user manual, package insert, and similar documentation, for the Product in effect on the date that the Product ships.  Documentation may be provided (including by reference to a website) with the Product at the time of shipment or provided electronically from Illumina.

 

“Existing Instruments” means Illumina Hardware that was purchased by Customer from Illumina or provided by Illumina prior to the Effective Date and that Customer intends to use with the Consumables purchased under this Agreement.   

 

“Facility” or “Facilities” means laboratories in the Country(ies) that are either owned by or leased by Customer.

 

“Field” means oncology, [...***...]. 

 

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“Illumina-Branded” means products that bear Illumina branding or the branding of any Affiliate of Illumina.

 

“Illumina Hardware” means Illumina-Branded instruments, accessories, and peripherals sold by Illumina or its Affiliates, including without limitation the Transferred Equipment (as defined in Section 22.c), accessories, and peripherals referenced in Section 22.c.

 

“Illumina Intellectual Property Rights” means all Intellectual Property Rights owned or controlled by Illumina or Affiliates of Illumina as of the date of shipment of the Product from Illumina. Application Specific IP, inclusive of Affiliate Application Specific IP, and Core IP are separate, non-overlapping, subsets within the Illumina Intellectual Property Rights.  

 

“Intellectual Property Right(s)” means all rights in patent, copyrights, trade secrets, know-how, trademark, service mark and trade dress rights and other industrial or intellectual property rights under the laws of any jurisdiction, together with all applications therefor and registrations thereto.

 

“Net Price” means [...***...].

 

“NIPT” means non-invasive pre-natal testing.

 

“Ordering Affiliates” means, as of the Restatement Date, the Affiliates of FMI set forth on Exhibit B attached hereto. From time to time, the Parties may mutually agree to modify Exhibit B by a signed written amendment to this Agreement.

 

“OTS TG Consumable” means a TG Consumable that, on the date that a corresponding Purchase Order is accepted, is listed on the webpage located at: http://www.illumina.com/IAOTS. 

 

“Product(s)” means the Consumables, Illumina Hardware, and Software that are offered for sale under, purchased under or otherwise governed by the terms and conditions of this Agreement.

 

“[...***...] Agreement” means the document to be entered into by and between Illumina and Customer that will define the responsibilities of each Party with respect [...***...].

 

“Research” means (i) internal research, and (ii) research services provided to third parties. Research Use includes [...***...].

  

“Research Use” means use for Research, specifically excluding any use that (i) is not in accordance with the Product’s Specifications or Documentation, (ii) requires grant of rights or a license to Application Specific IP or Affiliate Application Specific IP, (iii) is a re-use of a previously used Consumable, (iv) is the disassembling, reverse-engineering, reverse-compiling, or reverse-assembling of the Product, (v) is the separation, extraction, or isolation of components of Consumables or other unauthorized analysis of the Consumables, (vi) gains access to or determines the methods of operation of the Product, (vii) is the use of a non-Illumina reagent/consumable with Illumina Hardware (unless the Specifications or Documentation state otherwise), or (viii) is the transfer  to a third party of, or sub-licensing of, Software or third-party software.

 

“Sample [...***...]” means [...***...].  For clarity, Sample [...***...] includes at least the following steps: [...***...]. 

 

“Service Contracts” means the Product maintenance, support, and technical services products that Customer may purchase as set forth in Exhibit A.  Service Contracts are subject to the separate conditions, limitations, and terms and conditions that are set forth in Appendix I.   

 

 

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“Software” means Illumina-Branded software (e.g., Illumina Hardware operating software, data analysis software), regardless of whether it is embedded in or installed on Illumina Hardware or provided separately.

 

“Specifications” means Illumina’s written specifications for a Product in effect for that Product on the date that the Product ships.

 

“Temporary Consumable(s)” means Non-TG Consumables purchased under this Agreement that (i) Illumina agrees in writing may be used for Customer Use, and (ii) Customer intends to use for Customer Use and for which a TG version of such Consumable is not available from Illumina in the applicable Country.  Non-TG Consumables purchased by Customer that Illumina agrees in writing may be used for Customer Use as a result of Illumina’s inability to supply TG Consumables, such written authorization not to be unreasonably withheld, are deemed to fall within the definition of Temporary Consumable.  As of the Restatement Date, the Parties acknowledge and agree that Non-TG Consumables operable on NovaSeq systems (including NovaSeq S1 Consumables, NovaSeq S2 Consumables and NovaSeq S4 Consumables) are deemed to fall within the definition of Temporary Consumable to the extent Customer uses (and informs Illumina in writing in advance of such use) any such Consumables for Customer Use (and Illumina hereby agrees to such Customer Use in accordance with clause (i) above), until such time that Illumina makes commercially available a TG Version of the applicable Consumable available in the applicable Country in accordance with and subject to Section 2.d.

 

“Term” or “term of this Agreement” means the term of this Agreement as defined in Section 19.a.

 

“Third Party IP” means the Intellectual Property Rights of third parties wherein third parties for purposes of this definition specifically exclude Affiliates of Illumina.  

2.Applicability of Terms and Conditions.  

 

	
 
	
a.
	
Exclusive Terms.  This Agreement exclusively governs the ordering, purchase, supply, and use of Product, and its terms shall override any conflicting, amending and/or additional terms contained in any Purchase Orders, invoices or similar documents, which are hereby rejected and shall be null and void.  Failure of Illumina or Customer to object to any such conflicting, amending and/or additional terms shall not constitute a waiver by Illumina or Customer, nor constitute acceptance by Illumina or Customer of such terms.  The conditions and restrictions on use and other activities set forth in this Agreement are bargained for conditions of sale and, therefore, control the sale of such Product and the rights in and to Products provided to Customer at purchase.  This Agreement may be amended in writing only.  For clarity, written amendments to this Agreement must be executed by officers of the Parties.  

 

	
 
	
b.
	
Consumables.  The Consumables that may be purchased by Customer under this Agreement are referenced or set forth in Exhibit A, as may be amended in writing by the Parties; provided that, Illumina will not unreasonably refuse to amend Exhibit A to add additional Consumables or remove existing Consumables. 

 

	
 
	
c.
	
Instruments.  The Illumina Hardware that may be purchased by Customer under this Agreement is set forth in Exhibit A.  Unless otherwise set forth in Exhibit A, the purchase price for Illumina Hardware will be agreed to in writing at the time of purchase.  Unless expressly set forth otherwise in this Agreement, (i) notification of changes to Illumina Hardware and Software are not provided, and (ii) only Illumina Hardware listed in Exhibit A, as may be amended from time-to-time in writing by the Parties, may be purchased under this Agreement; provided that, Illumina will not unreasonably refuse to amend Exhibit A to add additional Illumina Hardware or remove existing Illumina Hardware.  

 

	
 
	
d.
	
Temporary Consumables.  This provision only applies to Temporary Consumables.  In the event Illumina makes commercially available in the applicable Country during the Term a TG version of a Temporary Consumable (“TG Version”), Customer must, within [...***...] months after the commercial 

 

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availability of the TG Version and receipt of notice from Illumina, cease ordering the Temporary Consumable for Customer Use.  No later than at expiration of the [...***...] month period, and only with respect to Consumables purchased for Customer Use, Illumina will supply Customer with only the TG Version of the applicable Consumable under the terms of this Agreement.  The Temporary Consumables shall, solely for the purposes of the Customer Use rights granted to Customer under Section 3, be considered to be TG Consumables until the expiration of the [...***...] month period described in the preceding sentence.  For the avoidance of doubt, after expiration of the [...***...] month period, Customer may use Non-TG Consumables (including former Temporary Consumables) only for Research Use.  Except as expressly set forth otherwise in writing by Illumina, notification of changes is not provided for Non-TG Consumables.  The [...***...] for such new TG Version [...***...] for such TG Version.

 

	
 
	
e.
	
[...***...] Business Reviews.  Customer and Illumina agree to have [...***...] business review meetings at mutually agreed upon times to discuss [...***...] and anything else mutually agreed upon.  The outcome of such business review meetings will not be binding unless documented in an amendment to this Agreement.

 

	
 
	
f.
	
Minimum TG Consumable Purchases.  Subject to the terms and conditions of this Agreement, Customer shall, purchase a minimum quantity of TG Consumables every [...***...] calendar months during the Term beginning [...***...], which shall be the greater of (i) [...***...]% of the quantity of TG Consumables forecasted for such [...***...] calendar month period as determined by Forecasts submitted by Customer that cover that time period, or (ii) $[...***...] (“Minimum Purchase Obligation”); provided that

 

(w) purchases of TG Consumables in each such [...***...] calendar month period by Customer under (1) this Agreement, (2) that certain Quotation for Supply of Genetic Analysis Products [...***...], as may be amended (Quotation # [...***...]), (3) Purchase Order [...***...], (4) Purchase Order [...***...], and (5) any other agreement entered into during the Term pursuant to which Customer purchases Consumables from Illumina to the extent the Parties expressly and mutually agree  in such other agreement that such purchases shall be applied toward the Minimum Purchase Obligation, in each case ((1) – (5)) shall be deemed a purchase of TG Consumables by Customer for the purpose of determining whether Customer has met the Minimum Purchase Obligation for the applicable [...***...] calendar month period, and

 

(x) if Customer does not meet its Minimum Purchase Obligation, (A) [...***...] shall immediately become null and void and of no further effect, and (B) all Product prices shall revert to the Base Price, regardless of Customer’s volume of purchases.

 

3.Rights Accompanying Purchase.  

 

	
 
	
a.
	
Consumables.  Subject to the terms and conditions of this Agreement (including without limitation the restrictions in Section 5), Customer’s purchase of TG Consumables, Temporary Consumables, and Non-TG Consumables under this Agreement confers upon Customer [...***...]. The Parties agree that the first sentence of this Section 3(a) is designed to and does alter the effect of the exhaustion of patent rights that would otherwise result if the sale was made without restriction.  Except as expressly stated in this Section 3(a) with respect to Core IP, no right or license under any Illumina Intellectual Property Rights is or are granted, expressly, by implication, or by estoppel, to Customer under this Agreement.  Any use of the Consumables recited in subparts (i) and (ii) herein outside the scope of rights expressly granted to Customer in this Section 3(a) is a prohibited use and is a breach of this Agreement.  Customer agrees that it will not use any such Consumable for a prohibited use.  Product recited in subparts (i) and (ii) herein may be covered by one or more U.S. or foreign patents.

 

	
 
	
b.
	
Illumina Hardware and Software.  Subject to the terms and conditions of this Agreement (including without limitation the restrictions in Section 5), Customer’s purchase of Illumina Hardware and Software 

 

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under this Agreement confers upon Customer [...***...].  The Parties agree that the first sentence of this Section 3(b) is designed to and does alter the effect of the exhaustion of patent rights that would otherwise result if the sale was made without restriction.  Except as expressly stated in this Section with respect to Core IP, no right or license under any Illumina Intellectual Property Rights is or are granted, expressly, by implication, or by estoppel, to Customer under this Agreement.  Any use of the Illumina Hardware or Software outside the scope of the rights expressly granted to Customer in this Section 3(b) is a prohibited use and is a breach of this Agreement.  Customer agrees that it will not use any such Illumina Hardware for a prohibited use.  Illumina Hardware may be covered by one or more U.S. or foreign patents.

 

	
 
	
c.
	
Existing Instruments.  Subject to the terms and conditions of this Agreement, including without limitation, all restrictions and all Customer representations and warranties hereunder with respect to Products, Customer (i), during the Term, has the right to use Existing Instruments for Customer Use, and (ii) during the Term and thereafter, has the right to use Existing Instruments for Research Use in accordance with the scope of rights in Section 3b (Illumina Hardware).  Customer agrees that Customer’s use of and disposition of the Existing Instruments is subject to the terms and conditions of this Agreement in addition to the original terms and conditions under which the Existing Instruments were purchased from Illumina (the “Instrument Terms”).  In the event of any conflict between the Instrument Terms and the terms and conditions of this Agreement with respect to the Existing Instruments, the terms and conditions of this Agreement shall supersede and govern Customer’s use of and disposition of the Existing Instruments.  Any use of the Existing Instruments outside of the scope of the rights expressly granted to Customer in Section 3(b) is a prohibited use and is a breach of this Agreement. Customer agrees that it will not use any such Existing Instrument for a prohibited use.  Existing Instruments may be covered by one or more U.S. or foreign patents

 

	
 
	
d.
	
Software. All Software is licensed, not sold, to Customer, is non-transferable, non-sublicensable, and may be subject to additional terms found in the Software’s end user license agreement (“EULA”).  Subject to the terms and conditions of the EULA and the terms and conditions of this Agreement (including without limitation, all restrictions in Section 5 and all Customer representations and warranties hereunder with respect to Products) Customer is expressly authorized to use Software provided by Illumina under this Agreement and provided by Illumina with Existing Instruments, as applicable, for Customer Use and Research Use, as applicable, when used with the Consumables and Illumina Hardware.  For clarity, Software may be used for Customer Use and Research Use when used with Consumables and Illumina Hardware for Customer Use and Research Use as authorized by this Agreement.

 

	
 
	
e.
	
[...***...] Agreement.  To the extent required and if applicable, the Parties shall work in good faith to amend that certain [...***...] Agreement by between FMI and Illumina entered into shortly after the Effective Date and which references this Agreement (such agreement, including as may be amended from time to time, the “[...***...] Agreement”) within [...***...] following the Restatement Date.  Subject to the terms and conditions of this Agreement, Customer and Illumina agree to comply with the terms of the [...***...] Agreement during the Term (as defined herein).  The Parties agree that the terms and conditions of the [...***...] Agreement may be amended from time-to-time by representatives of the Parties’ respective [...***...] departments; provided that, such amendments are done in writing and signed by such representatives.

 

	
 
	
f.
	
Service Contract.  During the Term, Illumina shall offer and Customer shall purchase and maintain a Service Contract for all Illumina Hardware that Customer uses, even if Illumina has determined to discontinue/phase out a given piece of Illumina Hardware (but in such event, only for a period of [...***...] following the date of obsolescence notification from Illumina to Customer for the applicable Illumina Hardware) or if there is a new version of such Illumina Hardware.  Existing service contracts that Customer has will terminate on the Effective Date and Illumina shall issue Customer a credit for any unused portion.  Subject to the terms of the Service Contract and the terms and conditions of this Agreement, Illumina will, [...***...]:

 

 

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i.
	
[...***...] Spare Parts.  Illumina will [...***...] parts for the Illumina Hardware used at [...***...], including [...***...] for [...***...] HiSeq and other Illumina Hardware and Software, within [...***...] of when the Parties determine [...***...]a given unit or piece of Illumina Hardware or Software.  

 

	
 
	
ii.
	
[...***...] 

 

	
 
	
iii.
	
Qualification Services.  Installation Qualification, Operational Qualification and Instrument Performance Verification are available upon the Customer’s request at any time during the term of this Agreement.  The Base Price for such services shall be set forth in the [...***...] Quotes to Customer, and verifiable on Illumina’s eCommerce platform (MyIllumina).  The descriptions of these services are listed below:

	
 
	
•
	
Installation Qualification: documentation that facilities in which the instrument has been installed are in accordance with requirements and safety regulations of the original manufacturer.

	
 
	
•
	
Operational Qualification: evaluates the correct functionality of the equipment under test by examining and quantifying the specifications after installation.

	
 
	
•
	
Instrument Performance Verification: ensures the accuracy of the instrument after a major service event or replacement of specific modules. 

	
 
	
•
	
Feedback from the Customer on any of these procedures will be considered and may be incorporated into future releases. Customer and Illumina will agree upon the format for such feedback.

 

4.Additional Rights; Application Specific IP.  

 

	
 
	
a.
	
Additional Rights.

 

	
 
	
i.
	
Customer’s intended use of Products for Customer Use or Research Use during the Term may require that it obtain from third parties or from Illumina (or its Affiliates) additional rights or licenses above and beyond the rights under Core IP conferred in Section 3, including without limitation, rights to Application Specific IP, Affiliate Application Specific IP, and Third Party IP.  Illumina does not guarantee or warrant that Customer’s intended use of Product will not infringe Application Specific IP, Affiliate Application Specific IP, or Third Party IP.

 

	
 
	
ii.
	
Customer, not Illumina, is responsible for identifying and ensuring that it has rights or licenses to all Intellectual Property, including without limitation, Application Specific IP, Third Party IP, and Affiliate Application Specific IP that are required for Customer to use the Products as intended by Customer for Customer Use and Research Use without infringing such third party and Illumina Intellectual Property Rights, including the Intellectual Property Rights of Illumina’s Affiliates.  Customer will obtain required rights to Third Party IP from a third party or required rights to Application Specific IP from Illumina or Affiliate Application Specific IP from Illumina’s Affiliate, or Customer will discontinue use of Products in a manner that infringes Third Party IP, Affiliate Application Specific IP, or Application Specific IP, as applicable.  

 

	
 
	
iii.
	
Notwithstanding the foregoing, any future grant by Illumina to Customer of rights to Application Specific IP or Affiliate Application Specific IP will be [...***...] granted, if at all, under a separate written agreement. 

 

	
 
	
iv.
	
Customer’s breach of any term or condition of this Section 4(a) is a breach of this Agreement.

 

5.Limitations on Use. 

 

	
 
	
a.
	
Limitations on Use.  

 

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i.
	
Customer agrees: (1) to use each Consumable only one time, (2) not to use non-Illumina reagents with Illumina Hardware, (3) to use the Products only within the scope of the rights expressly granted to Customer in Section 3 (Rights Accompanying Purchase) and (4) to only use Products in Customer’s Facilities.  The limitations in (1)-(2) do not apply if the Specifications or Documentation for the applicable Consumable expressly states otherwise.  [...***...].  

 

	
 
	
ii.
	
Customer agrees it will not, and it will not authorize any third party to, engage in any of the following activities: (1) disassemble, reverse-engineer, reverse-compile, or reverse-assemble the Product, (2) separate, extract, or isolate components of Product or subject Product or components thereof to any analysis not authorized in the Specifications or Documentation, (3) gain access to or attempt to determine the methods of operation of the Product, (4) grant a sub-license to any rights received hereunder, including to grant a sublicense to any Software or to any third-party software, or (5) transfer any Software to a third party.  [...***...]. 

 

	
 
	
iii.
	
Customer agrees it will not (1) use the Products for any use outside of Customer Use or Research Use, (2) use the Products in any manner that infringes, or is within the scope of, Application Specific IP including Affiliate Application Specific IP, unless it has received prior express written permission from Illumina under a separate written agreement or amendment to this Agreement to use the Products in a manner addressed in (1) or (2).

 

	
 
	
b.
	
Illumina Proprietary Information.  Customer agrees that it shall only use the Illumina proprietary sequences [...***...] for its own internal use with the Products.  Customer agrees that the contents of and methods of operation of the Products are proprietary to Illumina and/or its Affiliates and contain or embody trade secrets of Illumina and/or its Affiliates.  

 

	
 
	
c.
	
Unauthorized Uses.  Customer agrees that (i) the activities described in Section 5a.i and Section 5a.ii (Limitations on Use) (A) are, without limitation, part of the bargained for conditions of sale of the Products, (B) are not included within the Customer Use or the Research Use or otherwise within the rights expressly provided to Customer pursuant to Section 3 (Rights Accompanying Purchase), and (C) each, including restrictions against the use of the Product to perform any of those activities, is an unauthorized use, may infringe Illumina Intellectual Property Rights, and is part of the bargained for conditions of sale of the Products; and (ii) any violation of or breach of any provision of this Section 5 or any use of the Products outside the scope of the rights expressly granted to Customer in Section 3 (Rights Accompanying Purchase) is a breach of this Agreement.

 

6.Forecasts for TG Consumables; Initial Shipment Date.  

 

	
 
	
a.
	
Forecast.  Customer shall, [...***...] being a “Forecast Due Date”), provide a written forecast detailing the quantity of TG Consumables, on a TG Consumable-by-TG Consumable basis, that Customer requires during [...***...] following that Forecast Due Date (each a “Forecast”).  For clarity, each Forecast starts with the [...***...] Forecast Due Date.  For the avoidance of doubt, Illumina has no obligation to provide TG Consumables during any Forecast period ([...***...]) if Customer has not provided a Forecast for that period as required by the terms of this Agreement, including by Forecast Due Date.

 

	
 
	
i.
	
One Forecast per Calendar Month Only.  Customer may only provide one Forecast per [...***...].  If Customer provides more than one Forecast in any [...***...] Illumina may elect to use any of the Forecasts provided in that [...***...] and the one used by Illumina shall be binding on the Customer.  Customer must provide a [...***...] Forecast.  If Customer does not provide a Forecast by the Forecast Due Date then Illumina, in its sole discretion, may consider the previously provided Forecast as the Forecast that is then due. 

 

	
 
	
ii.
	
Initial Shipment Date.  Notwithstanding anything in this Agreement to the contrary, Illumina makes no guarantee that it can ship TG Consumables earlier than [...***...] from the Effective Date.  For 

 

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clarity, each Product has a unique catalog number (e.g., TG Consumables have a different catalog number than its corresponding Non-TG Consumable) and therefore Customer will only be required to pay the price associated with the TG Consumable when Customer is purchasing a TG Consumable. Notwithstanding the foregoing, the shipment dates set forth in this Section 6.a.ii shall not apply to OTS TG Consumables, which shall be shipped as such OTS TG Consumables are available using commercially reasonable efforts and no later than [...***...] after Customer submits a Purchase Order requesting the applicable OTS TG Consumable. 

 

	
 
	
b.
	
Binding Commitments; Flexibility.  The [...***...] provided under this Agreement is a binding commitment by Customer to take receipt of and pay for that quantity and type of TG Consumables found in such [...***...] (the “Binding Consumable [...***...]”); provided that, the quantity of each TG Consumable (on a TG Consumable-by-TG Consumable basis) to be delivered in such [...***...] may vary from the quantity of each TG Consumable (on a TG Consumable-by-TG Consumable basis) that were forecasted to be required in the same [...***...] as found in prior Forecast ([...***...] of that prior Forecast) only by up to [...***...]%.  ILMN shall use good faith efforts to accommodate any changes to Forecasts or Purchase Orders reasonably requested by Customer, including any such requests to modify Product quantities or replace a Product with a different Product in a given Forecast or Purchase Order.

 

	
 
	
c.
	
New TG Consumables.  Any TG Consumables that are newly added to this Agreement shall initially be forecasted so that the quantities for purchase and delivery in the first [...***...] are [...***...].

 

7.Pricing; Purchase Orders.  

 

	
 
	
a.
	
Pricing.  Customer shall pay the Net Price for Product.  Unless expressly stated otherwise in this Agreement, (i) all prices are in the applicable currency set forth on the invoice (which shall be the same currency set forth on the [...***...] Quote for the applicable Product), and (ii) all payments for such Products shall be in the applicable currency set forth on the invoice. For any invoiced amounts that were not in US dollars, the Parties shall use the average daily exchange rate on OANDA (e.g., available as of the Restatement Date at https://www.oanda.com/currency/converter/) for the calendar month in which the invoice date occurs to convert the total invoiced amount that is not in US dollars in such calendar month to a US dollar amount for the purpose of determining the applicable amounts in US dollars under this Agreement (e.g., in order to determine if Customer has met the Minimum Purchase Obligation and to determine the [...***...].)

 

	
 
	
b.
	
Purchase Orders.  

 

	
 
	
i.
	
Purchase Orders and Acceptance.  Customer shall order Product using written purchase orders (“Purchase Order(s)”).  Purchase Orders shall state, at a minimum, the Illumina part number, the Illumina provided quote number (or other reference provided by Illumina), the quantity ordered, price, requested delivery date, and address for delivery.  All Purchase Orders shall be sent to the attention of Illumina Customer Solutions or to any other person or department designated by Illumina in writing.  Acceptance of a Purchase Order occurs when Illumina provides Customer a Sales Order Confirmation (“Order Confirmation”).  Purchase Orders submitted in accordance with this Agreement will not be unreasonably rejected by Illumina.  

 

	
 
	
ii.
	
TG Consumable Purchase Orders.  The first Purchase Order for TG Consumables must be provided with the first Forecast.  Subsequent Purchase Orders for TG Consumables must be provided on the Forecast Due Date and must be for a quantity of and type of TG-Consumables as found in the Binding Consumable [...***...].  For the avoidance of doubt, Illumina has no obligation to provide TG Consumables found in the Binding Consumable [...***...] if Customer has not provided a Purchase Order by the Forecast Due Date and the failure to provide a Purchase Order will not relieve Customer of any of its obligations arising from Forecasts and such failure may, among other things, result in a delay in delivery of Products to Customer.  Each Purchase Order for TG Consumables must include a 

 

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ship schedule, to be agreed to between Illumina and Customer, that details the quantity of and type of TG Consumables (on a TG Consumable-by-TG Consumable basis) that Customer requires in each calendar month that is covered by the Purchase Order (“Ship Schedule”).  Illumina has no obligation to accept Purchase Orders that contain TG Consumables or quantities of TG Consumables that exceed what was forecasted by Customer (“Excess Orders”); provided that, Illumina [...***...] reject such Excess Orders that do not [...***...]% of the quantity forecasted unless Illumina agreeing to supply such excess quantity of TG Consumables (i) requires Illumina exercising anything [...***...], or (ii) would impair Illumina’s ability to honor supply commitments to other customers.  Such additional quantities of TG Consumables must be ordered by using Additional Purchase Orders (set forth below).  

 

	
 
	
iii.
	
Additional Purchase Orders for TG Consumables.  Illumina will, in its reasonable discretion, accept additional Purchase Orders for additional quantities of TG Consumables that were not within a given Forecast (“Additional Purchase Orders”).  Ship dates and quantities of TG Consumables on any Additional Purchase Orders will be mutually agreed to in writing. 

 

	
 
	
c.
	
Payment Instead of TG Consumables.  Illumina reserves the right to invoice Customer for [...***...]% of the purchase price for any TG Consumables that (a) Customer has a binding commitment to purchase under this Agreement under a Forecast, but for which Customer never provides a Purchase Order therefore or (b) Customer provides a Purchase Order for, but subsequently cancels the order or delivery thereof.  [...***...] failure to purchase TG Consumables under a binding commitment under this Agreement (whether under Forecast or a Purchase Order).

 

	
 
	
d.
	
Inability to Supply due to Force Majeure; [...***...].  

 

	
 
	
i.
	
Inability to Supply due to Force Majeure.  Subject to the terms and conditions of this Agreement, in the event Illumina is unable to perform its obligations under this Agreement due to a Force Majeure Event (defined in Section 22(j)), [...***...].   

 

	
 
	
ii.
	
[...***...].  Subject to the terms and conditions of this Agreement, Illumina shall promptly notify Customer if Illumina reasonably believes that Illumina will not have sufficient capacity to supply Customer with the quantity of Products set forth in Customer’s most recent Forecast.  In the event such capacity constraint exists, Illumina shall [...***...].      

 

	
 
	
e.
	
On Time Deliveries (Applicable to TG Consumables Only). The “Promised Delivery Date” for a TG Consumable  shipped from Illumina’s facilities located in (i) the same country as Customer’s Facility shall be the date that is [...***...], and (ii) a different country than Customer’s Facility shall be the date that is [...***...] after the shipment date for such TG Consumable stated in the Order Confirmation; provided that, Customer and Illumina agree that the shipment date found in the Order Confirmation may be adjusted by mutual agreement of representatives of the Parties, such mutual agreement may be made via email, fax, or in a written and signed agreement.  “[...***...]” means [...***...] and no later than [...***...] after the [...***...].  Customer shall earn a credit in an amount equal to [...***...]% of the Net Price for each [...***...] that does not meet [...***...]; provided that, [...***...].  This Section 7.e provides [...***...] in a timely manner under this Agreement.  For the avoidance of doubt [...***...].  Illumina shall provide Customer with [...***...].

 

	
 
	
i.
	
Reporting Late Deliveries.  Within [...***...] of the end of each calendar quarter of this Agreement and within [...***...] of termination or expiration of this Agreement (the “Due Date”), Customer will submit a written report to Illumina detailing [...***...], and in the case of termination or expiration of this Agreement since the end of the last reporting period, for which Customer is seeking [...***...] pursuant to Section 7e (the “Late Delivery Report”).  The Late Delivery Report shall be sent in writing to: [...***...].  The Late Delivery Report must include the following: [...***...] 

 

 

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f.
	
[...***...].  Illumina will review the Late Delivery Report.  In the event of any discrepancies the Parties will negotiate in good-faith to resolve the matter.  Illumina will [...***...] within [...***...] of the Late Delivery Report; provided that, [...***...].

 

8.Invoices; Payment; Taxes.  

 

	
 
	
a.
	
Invoices and Payment.  Illumina shall issue invoices upon shipment of Products.  Invoices shall be sent to Customer’s accounts payable department, or any other address designated by Customer in writing.  All payments by Customer on such invoices are due within [...***...] after (1) receipt of the invoice by Customer for Consumables, and (2) receipt by Customer of the corresponding Installation Certification for Illumina Hardware.  Any amounts not paid when due under this Agreement (other than amounts disputed by Customer in good-faith) will accrue interest at the rate of [...***...]% per month, or the maximum amount allowed by law, if lower.  In the event that any payment is not made within [...***...] after receiving notice of the delinquency, Customer will be in breach of this Agreement and Illumina shall have the right to take any action allowed in law and in equity in addition to any rights under this Agreement, including without limitation, revoke the rights conferred and/or licenses given hereunder and suspend performance, including shipment, until all payments are made current.  Customer shall pay for all costs (including reasonable attorneys’ fees) incurred by Illumina in connection with the collection of late payments.  Each Purchase Order is a separate, independent transaction under this Agreement, and Customer has no right of set-off against other Purchase Orders or other transactions with Illumina. Customer agrees to pay for Products supplied hereunder in accordance with the terms and conditions of this Agreement.  Illumina Hardware shall be deemed accepted by Customer following (a) delivery and installation of the applicable Illumina Hardware by Illumina and (b) receipt by Customer of an installation certification in a form mutually agreed to by the Parties and specifically including the results of a PhiX control sequencing run (“Installation Certification”).  

 

	
 
	
b.
	
Taxes. All prices and other amounts payable to Illumina hereunder are exclusive of and are payable without deduction for taxes, GST, VAT, customs duties, tariffs or charges now or hereafter claimed or imposed by any governmental authority upon the sale of the Product, all of which will be added to the purchase price or subsequently invoiced to the Customer.  With respect to New Zealand Customers only, Customer and Illumina agree that subsection 8(4) Goods and Services Tax Act 1985 does not apply.            

 

9.Shipping Terms; Title and Risk of Loss.  Illumina agrees that Customer may choose the carrier for shipments.  Unless otherwise agreed upon in writing, all shipments are made DAP (Incoterms 2010) at Customer’s address on the Purchase Order and Customer is responsible for freight and insurance which will be added to the invoice and paid by Customer, except that all shipments to member countries of the E.U. are made DDP (Incoterms 2010) at Customer’s address on the Purchase Order.  In all cases title (except for Software and third-party software) and risk of loss transfers to Customer when Product is delivered to such address.  

 

10.Consumable Shelf-life for TG Consumables.  The TG Consumables shall have no less than [...***...] shelf life at the time of shipment.  Shelf-life will be pre-printed on the TG Consumable packaging.

 

11.Single Lot Shipments/ Kit Lot Testing for TG Consumables. 

 

	
 
	
a.
	
Single Lot Shipments.  Illumina shall ensure (i) each shipment of a given TG Consumable includes only such TG Consumable manufactured from the same lot, (ii) each lot of TG Consumables and lot of kits containing TG Consumables is assigned a unique manufacturing lot number, which is displayed on each component, and (iii) each kit in a kit lot is comprised of component of TG Consumables manufactured from the same lots.   

  

	
 
	
b.
	
Kit Lot Testing.  Illumina shall test each component reagent that comprises a given TG Consumable together with the other component reagents of that TG Consumable to ensure their functionality, unless 

 

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sufficient data are available to demonstrate that a given component reagent, or component reagents, if quality tested independently, does not affect performance of the TG Consumable.

 

	
 
	
c.
	
Certificates of Analysis.  Illumina shall, once made available for all TG Consumables as part of Illumina’s standard commercial offering for TG Consumables, provide a Certificate of Analysis for each lot of TG Consumables sold to Customer under this Agreement.

 

12.Changes to Certain Product; Discontinuations

	
 
	
a.
	
[...***...].  In cases where [...***...] purchased under this Agreement is being [...***...] out or there is a [...***...] of such [...***...] that results in a change to [...***...], Illumina shall make [...***...] to provide Customer with a [...***...] advance notice [...***...] to the [...***...].  Illumina will notify Customer of the [...***...] options available should Customer desire to replace such [...***...]. This change notice will not apply to changes necessitated by causes beyond Illumina’s control or for changes necessary for safety which changes shall be communicated to Customer as soon as practicable after Illumina learns of the need for the changes through Illumina’s normal communication channels for changes.

 

	
 
	
b.
	
Discontinued/Changed TG Consumables.  TG Consumables will not be manufactured in their current configurations indefinitely as a result of product life cycle or other business considerations.  Accordingly, a given  Consumable Kit may be phased out of production and no longer available and/or there may be a new, reconfigured, or repackaged version of such Consumable Kit that embodies a material change to form, fit or function of such TG Consumable (such discontinued or materially changed Consumable is referred to as a “Discontinued Consumable”).  Any product or combination of products that is intended by Illumina to replace such Discontinued Consumable shall be referred to as a “Substitute Consumable.” In some instances a Substitute Consumable may differ from the Discontinued Consumable through changes in one or more components that comprised the Discontinued Consumable (“Changed Components”).  In other instances the Substitute Consumable may represent a complete change from the Discontinued Consumable (“Complete Change”).  In the case of a Discontinued Consumable that will have Changed Components, Illumina will provide Customer at least [...***...] prior written notice thereof and will use [...***...], but no later than [...***...] prior to the date that the Discontinued Consumable will no longer be available for purchase.  Illumina will provide [...***...].  In the case of a Discontinued Consumable that will have a Complete Change, Illumina will provide Customer at [...***...] prior written notice thereof and will make the Substitute Consumable available for purchase by Customer [...***...] no later than [...***...] prior to the date that the Discontinued Consumable will no longer be available for purchase.  Illumina will provide [...***...] free of charge [...***...].  Once a Discontinued Consumable is no longer available for purchase (either in the instance of a Complete Change or Changed Component), the Substitute Consumable will automatically be added to this Agreement as a Consumable and the Discontinued Consumable will be removed.  The price for a Substitute Consumable will be [...***...] for the Substitute Consumable.  Use of Substitute Consumables shall be subject to the terms and conditions of this Agreement.  Notwithstanding anything to the contrary in this Agreement, if Illumina offers a product or combination of products that, [...***...], Illumina may require Customer to begin purchasing such product in lieu of the Product and the Parties will work together [...***...] to coordinate such transition and to modify the terms of this Agreement to reflect such change.    

 

13.Regulatory; Quality Audits.  

 

	
 
	
a.
	
Research Use.  Customer acknowledges that, unless expressly stated otherwise in writing by Illumina, the Products have not been subjected to regulatory review or approved or cleared by the United States Food and Drug Administration or any other regulatory entity whether foreign or domestic, or otherwise reviewed, cleared or approved under any statute, law, rule or regulation for any purpose, whether research, commercial, diagnostic or otherwise.  The Products are labeled For Research Use Only.  Illumina does not make any representation, warranty or covenant that pertains in any way to the regulatory status of the Products and Customer’s intended use for Customer Use.

 

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b.
	
Regulatory Approvals.  Customer, and not Illumina, is responsible for obtaining any and all regulatory approvals, licenses, and/or certifications necessary for Customer to use the Products as intended by Customer, including without limitation, for Customer Use or Research Use (“Regulatory Approvals”).  Customer will ensure it has any regulatory approvals that are necessary for Customer’s intended use of the Products.  Accordingly, Customer agrees to (i) diligently investigate and identify which Regulatory Approvals apply to Customer’s use of the Products, (ii) obtain and maintain all Regulatory Approvals throughout the time that Customer uses the Products, and (iii) use the Products in compliance with all applicable laws and regulations.  Customer agrees to promptly disclose to Illumina any communication that it receives from a government body, agency, or other regulatory or accrediting body pertaining to the Products or Customer’s use of the Products.        

 

	
 
	
c.
	
Quality Audits.  Illumina agrees to allow Customer to audit Illumina’s operations that pertain to [...***...], upon [...***...] prior written notice, during normal business hours, no more often than [...***...], and at [...***...], in order to satisfy its obligations under applicable law.  The locations, times, dates, scope, and goals for such audits will be mutually agreed upon in writing between the Parties.  The confidentiality provisions of Section 16 shall apply to any such audits, and if requested by Illumina, the Parties shall enter into a confidentiality agreement in a form to be agreed by the Parties prior to Customer conducting any such audit. [...***...]

 

14.Limitation of Liability.  

EXCEPT WITH RESPECT TO ANY CLAIM OR LIABILITY ARISING OUT OF A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS HEREUNDER, TO THE EXTENT PERMITTED BY LAW, IN NO EVENT SHALL EITHER PARTY OR THEIR RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS OR SERVICES, LOST PROFITS, DATA OR BUSINESS, OR FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH, WITHOUT LIMITATION, THE PURCHASE OR SALE OF THE PRODUCTS, THEIR USE, SUCH PARTY’S PERFORMANCE HEREUNDER OR ANY OF THESE TERMS AND CONDITIONS, HOWEVER ARISING OR CAUSED AND ON ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE).  

 

EXCEPT WITH RESPECT TO THE PARTY’S INDEMNIFICATION OBLIGATIONS AND ANY CLAIM OR LIABILITY ARISING OUT OF A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS HEREUNDER, EACH PARTY’S TOTAL AND CUMULATIVE LIABILITY ARISING UNDER OR IN CONNECTION WITH THIS AGREEMENT, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE, SHALL IN NO EVENT EXCEED AN AMOUNT EQUAL TO [...***...]. 

 

THE LIMITATION OF LIABILITY IN THIS SECTION SHALL APPLY EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.  

 

NOTWITHSTANDING ANYTHING IN THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, THIS SECTION 14, TO THE CONTRARY, NOTHING IN THIS AGREEMENT SHALL LIMIT EITHER PARTY’S LIABILITY TO THE OTHER PARTY OR ITS AFFILIATES FOR [...***...]. 

 

15.Limited Warranties.  TO THE EXTENT PERMITTED BY LAW AND EXCEPT FOR THE EXPRESS LIMITED PRODUCT WARRANTIES SET FORTH IN SECTION 18 OF THIS AGREEMENT, ILLUMINA MAKES NO (AND EXPRESSLY DISCLAIMS ALL) WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, WITH RESPECT TO THE PRODUCTS OR ANY SERVICES PROVIDED IN CONNECTION WITH THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR ARISING 

 

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FROM COURSE OF PERFORMANCE, DEALING, USAGE OR TRADE.  WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, ILLUMINA MAKES NO CLAIM, REPRESENTATION, OR WARRANTY OF ANY KIND AS TO THE UTILITY OF THE PRODUCTS FOR CUSTOMER’S INTENDED USES. 

 

16.Confidentiality.

 

	
 
	
a.
	
Confidential Information.  The Parties acknowledge that a Party (the “Recipient Party”) may have access to confidential or proprietary information (“Confidential Information”) of the other Party (the “Disclosing Party”) under this Agreement.  In order to be protected as Confidential Information, information must be disclosed with a confidential or other similar proprietary legend and in the case of orally or visually disclosed Confidential Information, the Disclosing Party shall notify the Recipient Party of its confidential nature at the time of disclosure and provide a written summary that is marked with a confidential or other similar proprietary legend to the Recipient Party within [...***...] (email acceptable).  Confidential Information may include, but shall not be limited to, inventions, designs, formulas, algorithms, trade secrets, know-how, customer lists, demand forecasts, cost and pricing information, business and marketing plans, and other business, regulatory, manufacturing and financial information.  This Agreement, including its terms and conditions is Confidential Information.  During the term of this Agreement or [...***...], whichever is longer, the Recipient Party shall hold the Disclosing Party’s Confidential Information in confidence using at least the degree of care that is used by the Recipient Party with respect to its own Confidential Information, but no less than reasonable care.  The Recipient Party shall disclose the Confidential Information of the Disclosing Party solely on a need to know basis to its employees, contractors, officers, directors, representatives, and Affiliates under written nondisclosure and restricted use terms consistent with this Agreement.  The Recipient Party shall not use the Disclosing Party’s Confidential Information for any purpose other than exercising its rights and fulfilling its obligations under this Agreement.  The Confidential Information shall at all times remains the property of the Disclosing Party.  Upon the termination or expiration of this Agreement, the Recipient Party shall, upon written request of the Disclosing Party, return to the Disclosing Party or destroy the Confidential Information of the Disclosing Party.  Notwithstanding the foregoing, the Recipient Party may maintain one copy of the Disclosing Party’s Confidential Information to be retained by the Recipient Party’s Legal Department for archival purposes only.   

 

	
 
	
b.
	
Exceptions. Notwithstanding any provision contained in this Agreement to the contrary, neither Party shall be required to maintain in confidence or be restricted in its use of any of the following: (i) information that, at the time of disclosure to the Recipient Party, is in the public domain through no breach of this Agreement or another obligation of confidentiality owed to the Disclosing Party or its Affiliates by the Receiving Party; (ii) information that, after disclosure hereunder, becomes part of the public domain by publication or otherwise, except by breach of this Agreement or breach of another obligation of confidentiality owed to the Disclosing Party or Affiliate by the Receiving Party; (iii) information that was in the Recipient Party’s or its Affiliate’s possession at the time of disclosure hereunder by the Disclosing Party unless subject to an obligation of confidentiality or restricted use owed to the Disclosing Party or its Affiliate; (iv) information that is independently developed by or for the Recipient Party or its Affiliates without use of or reliance on Confidential Information of the Disclosing Party; or (v) information that the Recipient Party receives from a third party where Recipient Party reasonably believes such third party was under no obligation of confidentiality to the Disclosing Party or its Affiliate with respect to such information.  

 

	
 
	
c.
	
Disclosures Required by Law.  The Recipient Party may disclose Confidential Information of the Disclosing Party as required by court order, operation of law, or government regulation, including in connection with submissions to regulatory authorities with respect to the Products; provided that, the Recipient Party promptly notifies the Disclosing Party of the specifics of such requirement prior to the actual disclosure, or promptly thereafter if prior disclosure is impractical under the circumstances, uses diligent efforts to limit the scope of such disclosure or obtain confidential treatment of the Confidential 

 

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Information if available, and allows the Disclosing Party to participate in the process undertaken to protect the confidentiality of the Disclosing Party’s Confidential Information including, without limitation, cooperating with the Disclosing Party in order to comply with the requirements of such order, law, or regulation in a manner that discloses the least amount necessary, if any, of the Confidential Information of the Disclosing Party.

 

	
 
	
d.
	
Injunctive Relief.  Each Party acknowledges that any use or disclosure of the other Party’s Confidential Information other than in accordance with this Agreement may cause irreparable damage to the other Party.  Therefore, in the event of any such use or disclosure or threatened use or threatened disclosure of the Confidential Information of either Party hereto, the non-breaching Party shall be entitled, in addition to all other rights and remedies available at law or in equity, to seek injunctive relief against the breach or threatened breach of any obligations under this Section.  

 

	
 
	
e.
	
Disclosure of Agreement.  Except as expressly provided otherwise in this Agreement, neither Party may disclose this Agreement, the terms of this Agreement, including any financial terms thereof, and the subject matter of this Agreement to any third party without the prior written consent of the other Party, which consent shall not be unreasonably withheld.  Notwithstanding anything in this Agreement to the contrary, each Party acknowledges and agrees that either Party may, to the extent required by applicable healthcare disclosure law, disclose this Agreement, its terms, its subject matter, including financial terms (e.g., Illumina’s compliance with the Sunshine Act).

 

17.Indemnity; Insurance.  

 

	
 
	
a.
	
Infringement.  Subject to the terms and conditions of this Agreement, including without limitation, the Exclusions to Indemnification Obligation (Section 17(b) below), Indemnification by Customer (Section 17(c) below), Conditions of Indemnification Obligation (Section 17(e) below), and Customer’s obligations to obtain rights to Third Party IP pursuant to Section 4 (Additional Rights), Illumina shall (i) defend, indemnify and hold harmless Customer and their respective officers, directors, representatives and employees (each a “Customer Indemnitee”), against any claim or action brought by a third party (who is not an Affiliate of Customer or an Affiliate of Illumina) as a result of the (A) Products when used for Research Use, and (B) Illumina Hardware, Software, TG Consumables, Replacement Non-TG Consumables and Temporary Consumables when used for Customer Use, in accordance with the terms and conditions of this Agreement, infringing the valid and enforceable Intellectual Property Rights of a third party (who is not an Affiliate of Customer or an Affiliate of Illumina) (“Illumina Infringement Claim”), and (ii) pay all settlements entered into, and all final judgments and costs (including reasonable attorneys’ fees) awarded against such Customer Indemnitee in connection with such Illumina Infringement Claim.  If the Products or any part thereof, become, or in Illumina’s opinion may become, the subject of an Illumina Infringement Claim against Illumina (including its Affiliates) or Customer, Illumina shall have the right, at its option, to (A) procure for Customer the right to continue using such Products, (B) modify or replace such Products with substantially equivalent noninfringing substitutes, or (C) require the return of such Products that are or may become the subject of an Illumina Infringement Claim and terminate the rights, license, and any other permissions given hereunder with respect thereto and refund to Customer the depreciated value (as shown in Customer’s official records) of the returned Product at the time of such required return; provided that, no refund will be given for used-up or expired Consumables.  This Section states the entire liability of Illumina for any infringement of third-party Intellectual Property Rights. 

 

	
 
	
b.
	
Exclusions to Indemnification Obligation.  Illumina shall have no obligation under Section 17(a), including to defend, indemnify or hold harmless Customer or pay any settlements with respect to any Illumina Infringement Claim, to the extent such Illumina Infringement Claim arises from: (i) the use of the Products in any manner or for any purpose outside the scope of the rights, license(s), or permissions granted by Illumina to Customer with respect to the Products under Section 3 (Rights Accompanying 

 

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Purchase), (ii) the use of the Products in any manner or for any purpose not in accordance with the Specifications or Documentation, (iii) the use of the Products in combination with any other products, materials, or services not supplied by Illumina, (iv) the use of the Products to perform any assay or other process not supplied by Illumina, (v) Illumina’s compliance with specifications or instructions for such Products furnished to Illumina by Customer or by a third party on behalf of Customer (e.g., custom goods), (vi) the use of the Products in any manner or for any purpose that requires rights to Application Specific IP, Affiliate Application Specific IP [...***...] or (vii) Customer’s breach of any term or condition, including breach of a representation or warranty, made hereunder or included in this Agreement, wherein any use specified in (i), (ii), (iii) (iv) or (vi) is a use performed by Customer, or a party to whom Customer transfers Product (regardless of whether transfer is permitted under this Agreement)  (each of (i) – (vii), are referred to as an “Excluded Claim”).     

 

	
 
	
c.
	
Indemnification by Customer.  Subject to the terms and conditions of this Agreement, including without limitation the Conditions of Indemnification provision below (Section 17e), Customer shall defend, indemnify and hold harmless Illumina, its Affiliates, their collaborators and development partners that contributed to the development of the Products, and their respective officers, directors, representatives and employees (“Illumina Indemnitee(s)”), against any third party claims, causes of action, and all liabilities, damages, fines, penalties, causes of action, and losses of any and every kind (“Claim”), including without limitation, claims relating to or arising out of personal injury or death, and claims relating to or arising out of infringement of a third party’s Intellectual Property Rights, to the extent a Claim results from, relates to, or arises out of (i) Customer’s breach of any term or condition, including breach of a representation or warranty made hereunder or included in this Agreement, (ii) Customer’s use of the Product outside of the scope of the rights, license(s), and permissions expressly granted to Customer with respect to such Product pursuant to Section 3 (Rights Accompanying Purchase), (iii) Customer’s use of a Product not in accordance with its Documentation or Specifications, (iv) any of the activities in (i) through (vii) of Excluded Claim, (v) Customer’s failure to obtain and maintain Regulatory Approvals, or (vi) any unauthorized use of the Products in any manner, or for any purpose that requires rights to Affiliate Application Specific IP, Application Specific IP, or Third Party IP.

 

	
 
	
d.
	
Further Indemnification by Illumina. In addition to and without limiting the obligations set forth under Section 17a and subject to the terms and conditions of this Agreement, including without limitation, the Conditions of Indemnification provision below (Section 17e), Illumina shall defend, indemnify and hold harmless each Customer Indemnitee against any Claims relating to or arising out of personal injury or death that results from Customer’s use of a defective Product purchased by Customer under this Agreement (“Personal Injuries”), specifically excluding any Personal Injuries (i) arising from or in any way relating to any actions (or inactions) taken by individuals or healthcare providers (e.g., persons, patients, physicians, healthcare providers) who receive results from Customer’s use of Products, and (ii) that could have been avoided by Customer using reasonable measures. 

 

	
 
	
e.
	
Conditions of Indemnification.  The Parties’ indemnification obligations under this Section 17 are subject to the Party seeking indemnification (i) notifying the other, indemnifying Party promptly in writing of an Illumina Infringement Claim or Third Party Claim, as the case may be, (provided that a delay in providing shall not relieve the other Party of its indemnification obligations except to the extent it is prejudiced by such delay) (ii) giving indemnifying Party exclusive control and authority over the defense of such Claim, (iii) not admitting infringement of any Intellectual Property Right without prior written consent of the indemnifying Party, (iv) not entering into any settlement or compromise of any such action without the indemnifying Party’s prior written consent not to be unreasonably withheld, conditioned, or delayed, and (v) providing all reasonable assistance to the indemnifying Party that the indemnifying Party requests and ensuring that its officers, directors, representatives and employees and  other indemnitees likewise provide assistance (provided that indemnifying Party reimburses the indemnified Party(ies) for its/their reasonable out-of-pocket expenses incurred in providing such assistance). An indemnifying Party will not enter into or otherwise consent to an adverse judgment or order, or make any admission as to liability or fault that would adversely affect the indemnified Party, or settle a dispute without the prior 

 

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written consent of the indemnified Party, which consent not to be unreasonably withheld, conditioned, or delayed.

 

	
 
	
f.
	
Third-Party Goods.  Notwithstanding anything in this Agreement to the contrary, Illumina shall have no indemnification obligations with respect to any goods or software originating from a third party and supplied to Customer under this Agreement.  Third-party goods are those that are labeled or branded with a third-party’s name.  Customer’s sole right to indemnification with respect to such third-party goods or software shall be pursuant to the original manufacturer’s or licensor’s indemnity, if any, to Customer, to the extent provided by the original manufacturer or licensor.  

 

	
 
	
g.
	
Insurance.  Customer shall obtain and maintain insurance coverage as follows: (i) a policy for liability (including professional and errors & omissions) in the amount of no less than [...***...] per occurrence, and (ii) separately a policy for commercial general liability and public liability insurance (that excludes product liability) in the amount of no less than [...***...], in the case of each of (i) and (ii) to protect the Illumina Indemnitees under the indemnification provided hereunder.  Illumina shall be an additional insured on Customer’s insurance policy or policies and, upon request, Illumina shall be provided appropriate certificates of insurance.  Such policies shall provide a waiver of subrogation against Illumina as an additional insured and contain no cross-liability exclusion.  Customer agrees that the Parties intend that Customer’s insurance coverage will be primary over any other potentially applicable insurance.  Customer shall ensure that any umbrella or excess liability coverage shall not treat the naming of Illumina as an additional insured as a coverage change that voids or terminates such coverage.  The policies may not be cancelled or amended without [...***...] prior written notice to Illumina, and the policies should so state.  Customer shall maintain such insurance at all times during this Agreement and for a period of [...***...].   

 

18.Warranty for Products.  All warranties are personal to Customer and may not be transferred or assigned to a third party.  All warranties for Products are Facility-specific and do not transfer if the Product is moved to another Facility of Customer, unless Illumina conducts or consents in writing to such move.  These warranties only apply to Products purchased under this Agreement.  

 

	
 
	
a.
	
Warranty for Consumables.  Illumina warrants that TG Consumables, other than custom TG Consumables, will have no less than [...***...] shelf-life at the time of shipment from Illumina and conform to their Specifications until the later of (i) [...***...] from the date of shipment from Illumina, and (ii) [...***...] by Illumina, but in no event later than [...***...] from the date of shipment.  Illumina warrants that Non- TG Consumables, other than custom Non-TG Consumables, will conform to their Specifications until the later of (i) [...***...] from Illumina, and (ii) any expiration date or the end of the shelf-life pre-printed on such Non-TG Consumable by Illumina, but in no event later than [...***...].  With respect to custom Consumables (i.e., Consumables, whether they are TG Consumables or Non-TG Consumables) made to specifications or designs made by Customer or provided to Illumina by, or on behalf of, Customer, Illumina only warrants that the custom Consumables will be made and tested in accordance with Illumina’s standard manufacturing and quality control processes.  Illumina makes no warranty that custom Consumables will work as intended by Customer or for Customer’s intended uses.  

 

	
 
	
b.
	
Warranty for Illumina Hardware.  Illumina warrants that Illumina Hardware, other than Upgraded Components, will conform to its Specifications for a period of [...***...] from Illumina unless the Illumina Hardware includes Illumina-provided installation in which case the warranty period begins on the date of installation or [...***...], whichever occurs first (such warranty to be known as the “Base Hardware Warranty”); provided that, the Base Hardware Warranty period for Illumina Hardware that requires Customer’s signature of document after passing certain testing criteria starts on the date that the Illumina Hardware passed such testing criteria.  “Upgraded Components” means Illumina-provided components, modifications, or enhancements to Illumina Hardware that was acquired by Customer prior to the date Illumina provides these Upgraded Components. Illumina warrants that Upgraded Components will conform to their Specifications for a period of [...***...].  Upgraded Components do not extend the 

 

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warranty for the Illumina Hardware unless the upgrade was conducted by Illumina at Illumina’s facilities in which case the upgraded Illumina Hardware shipped to Customer comes with a Base Hardware Warranty.

 

	
 
	
c.
	
Exclusions from Warranty Coverage.  The foregoing warranties in Section 18(a) and (b) shall not apply to the extent a non-conformance is due to (i) abuse, misuse, neglect, negligence, accident, improper storage, or use contrary to the Documentation (misuse includes use of a Consumable more than one time), (ii) improper handling, installation, maintenance, or repair (other than by Illumina personnel), (iii) unauthorized alteration, (iv) acts of God, including without limitation, fire, flood, tornado, earthquake, hurricane, lightning, threat of or actual acts of terrorism or war, or (v) use with a third party’s good not provided by Illumina (unless its Documentation or Specifications expressly state such third party’s good is for use with it).

 

	
 
	
d.
	
Sole Remedy.  In the event Product does not conform to warranty, Illumina will repair, replace or provide a credit for the Product, as set forth below.  The following states Customer’s sole remedy and Illumina’s sole obligations under the foregoing warranties.

 

	
 
	
i.
	
Consumables. Replaced Consumables come with the same warranty as a new Consumable.  For any Consumables that Customer claims fail to conform to the applicable warranty and for which Illumina is able to reasonably confirm such non-conformance (“Non-Conforming Consumables”), Illumina will issue to Customer a credit of [...***...]%) of the invoice price of the Non-Conforming Consumables, provided that on a case-by-case basis and to the extent Customer requests in writing, Illumina shall provide Customer Non-TG Consumables as a replacement for any Non-Conforming Consumables that are TG Consumables (any such replacement Non-TG Consumables, “Replacement Non-TG Consumables”) and shall issue to Customer a credit for [...***...]. Further, if Customer did not require Illumina to use a specific carrier for a given Product shipment and to the extent that Customer provides an initial notification to Illumina in writing within [...***...] following receipt of the applicable shipment that any Consumables in such shipment are Non-Conforming Consumables due to damage to the applicable Consumables during shipment (and provides a second notification within [...***...] following Customer’s receipt of such shipment, confirming that Customer believes such Consumables to be Non-Conforming Consumables due to damage to the applicable Consumables during shipment), then in addition to all other remedies set forth in this Section 18.d.ii (including any credits), Illumina shall issue to Customer a credit of [...***...]%) of the invoice price of the Non-Conforming Consumables.  Illumina shall promptly credit Customer’s account for any credits issued pursuant to this Section 18.d.ii.

 

	
 
	
ii.
	
Illumina Hardware. Illumina will repair or replace the Illumina Hardware in its discretion; provided that Illumina will repair or replace such Illumina Hardware in Customer’s sole discretion if (1) a given piece of Illumina Hardware has been previously repaired [...***...] for the same or similar defect that caused such Illumina Hardware to fail to meet the applicable Illumina Hardware warranty, including any defect resulting from Illumina’s (or Illumina’s agent’s) failure to fully correct a previously repaired defect or (2) within [...***...], Customer determines that such given piece of Illumina Hardware fails to meet Customer’s validation requirements.  Illumina Hardware may be repaired or replaced with functionally equivalent, reconditioned, or new Illumina Hardware or components (if only a component of Illumina Hardware is non-conforming).  If the Illumina Hardware is replaced in its entirety, the warranty period for the replacement Illumina Hardware shall be the later of (a) [...***...] and (b) [...***...]; provided that if Customer unreasonably prohibits Illumina from delivering and installing a given piece of replacement Illumina Hardware for more than [...***...], the time period specified in clause (a) of this sentence shall be [...***...].  If only a component is being repaired or replaced, the warranty period for such component is [...***...] (and Illumina shall provide [...***...], or [...***...], whichever is longer.  

 

 

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e.
	
Procedure. In order to be eligible for repair or replacement under this warranty Customer must (i) promptly contact Illumina’s customer support department to report the non-conformance, (ii) cooperate with Illumina in the diagnosis of the non-conformance, and (iii) return the Product, transportation charges prepaid, to Illumina following Illumina’s instructions or, if agreed by Illumina, grant Illumina’s authorized repair personnel access to this Product in order to confirm the non-conformance and make repairs.

 

	
 
	
f.
	
Third-Party Goods.  Illumina has no warranty obligations with respect to any goods or software originating from a third party and supplied to Customer under this Agreement.  Third-party goods or software are those that are labeled or branded with a third-party’s name.  The warranty for third-party goods or software, if any, are provided by the original manufacturer.  Illumina will cooperate with Customer in filing any warranty claims with such third parties.

 

19.Term; Cancellation; Termination.  

 

	
 
	
a.
	
Term.  This Agreement shall commence on the Effective Date and terminate on the [...***...] anniversary of the Restatement Date (the “Term”) unless otherwise terminated early as provided hereunder.  

 

	
 
	
b.
	
Termination.  Without limiting any other rights to terminate expressly provided in this Agreement or under law, this Agreement may be terminated early as follows:  

 

	
 
	
i.
	
Breach of Agreement.  If either Party materially breaches this Agreement and fails to cure such breach within [...***...] after receiving written notice of the breach, the non-breaching Party shall have the right to terminate this Agreement by providing written notice to the other Party.  The Parties agree that a material breach of Section 3.a (Rights Accompanying Purchase – Consumables), 3.b (Rights Accompanying Purchase – Illumina Hardware and Software), 3.c (Existing Instruments), 5 (Limitation on Use), 17.g (Insurance), 22.g (Assignment) or 22.h (Export) is a material breach of this Agreement.

 

	
 
	
ii.
	
Bankruptcy.  Either Party may terminate this Agreement, effective immediately upon written notice, if the other Party becomes the subject of a voluntary or involuntary petition in bankruptcy or any proceeding relating to insolvency, receivership, liquidation or composition for the benefit of creditors that is not dismissed within [...***...].  In the event of any bankruptcy or insolvency proceeding commenced by or against Customer, Illumina shall be entitled to cancel any Purchase Order then outstanding and not accept any further Purchase Order until bankruptcy or insolvency proceeding is resolved. 

 

	
 
	
iii.
	
Continuous Supply Failure.  Subject to the terms and conditions of this Agreement, Customer may terminate this Agreement early by providing [...***...] prior written notice in the event Illumina does not provide TG Consumables or Temporary Consumables for valid Purchase Orders accepted by Illumina for a period of [...***...].

 

	
 
	
c.
	
Right to Cease Delivery.  In addition to any other remedies available to Illumina under this Agreement, in equity, or at law, Illumina reserves the right to cease shipping Product to Customer immediately if Customer (1) uses the Product outside the scope of the rights expressly conferred to Customer pursuant to Section 3 (Rights Accompanying Purchase) of this Agreement, (2) fails to pay undisputed invoices that are [...***...] past due, (3) materially breaches any provision of Section 5, or (4) materially breaches any Customer representation or warranty made hereunder.   

 

20.Survival of Obligations   All provisions of this Agreement that by their nature should survive termination or expiration of this Agreement shall survive termination or expiration, including without limitation, Sections 1 (Definitions),2.a (Applicability of Terms and Conditions – Exclusive Terms), 3.a (Rights Accompanying Purchase – Consumables), 3.b (Rights Accompanying Purchase – Illumina Hardware and Software), 3.d (Rights Accompanying Purchase – Software), 4.a. (Additional Rights), 5 (Limitations on Use), 7.a (Pricing; Purchase 

 

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Orders – Pricing), 7.c (Pricing; Purchase Orders – Payment Instead of Taking TG Consumable), 7.e (Pricing; Purchase Orders – On Time Deliveries), 8 (Invoices; Payment; Taxes), 9 (Shipping Terms; Title and Risk Loss), 13.a (Regulatory; Quality Audits – Research Use), 13.b (Regulatory; Quality Audits – Regulatory Approvals), 14 (Limitation of Liability), 15 (Limited Warranties), 16 (Confidentiality), 17 (Indemnity; Insurance), 18 (Warranty for Products), 19 (Term; Cancellation; Termination), 20 (Survival of Obligations), 21 (Governing Law), and 22 (Miscellaneous), and all payment obligations incurred hereunder.  Termination or expiration of this Agreement shall not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice either Party’s right to obtain performance of any obligation. 

 

21.Governing Law.  This Agreement and performance by the Parties hereunder shall be construed in accordance with the laws of the State of New York, U.S.A., without regard to provisions on the conflicts of laws.

      

22.Miscellaneous. 

	
 
	
a.
	
Representations and Warranties.  

 

	
 
	
i.
	
Customer.  Customer represents and warrants that (i) it owns or leases the Facilities; (ii) it has the right and authority to enter into this Agreement; (ii) it has all rights and licenses necessary to purchase and use the Products; (iii) it does not require a license to any Illumina Application Specific IP, including without limitation, any Affiliate Application Specific IP in order to use the Products; (iv) when performing Customer Use, it will only use the TG Consumables and Temporary Consumables; (v) it will use the Non-TG Consumables only for Research Use; and (vi) the person(s) signing this Agreement on its behalf has the right and authority to bind Customer to the terms and conditions of this Agreement. Further, in the case of Foundation Medicine, Inc., Foundation Medicine, Inc. represents and warrants that (i) the person(s) signing this Agreement on its behalf has the right and authority to bind FMI Germany GmbH to the terms and conditions of this Agreement, (ii) FMI Germany GmbH is a wholly-owned subsidiary of Foundation Medicine, Inc., and (iii) Foundation Medicine, Inc. is jointly and severally liable for the acts or omissions of FMI Germany GmbH.

 

	
 
	
ii.
	
Illumina.  Illumina represents and warrants that (i) it has the right and authority to enter into this Agreement, (ii) it has all rights and licenses necessary to sell the Products in accordance with the terms and conditions of this Agreement, and (iii) the person signing this Agreement on its behalf has the right and authority to bind Illumina to the terms and conditions of this Agreement. 

 

	
 
	
b.
	
Illumina Affiliates.  Customer agrees that Illumina may delegate its performance under this Agreement to one or more of its Affiliates.  Illumina invoices and other documentation may come from an Illumina Affiliate and Customer shall honor those just as if they came directly from Illumina.

 

	
 
	
c.
	
Transferred Illumina Hardware.  In accordance with that certain letter agreement dated [...***...], by and among Customer, Illumina and Sequenom, Inc. (the “Letter Agreement”), the equipment set forth on Exhibit A to the Letter Agreement (“Transferred Equipment”) shall be deemed Illumina Hardware under this Agreement, and all of the terms and conditions of this Agreement shall apply to such Transferred Equipment except Section 9 (Shipping Terms; Title and Risk of Loss), Section 12.a (Illumina Hardware), and Section 18 (Warranty).

 

	
 
	
d.
	
Legal Compliance.  Nothing in this Agreement is intended, or should be interpreted, to prevent either Party from complying with all applicable laws, regulations, or governmental orders.

 

	
 
	
e.
	
Documentation; Hierarchy of Documents.  Customer agrees that it shall use the Documentation in accordance with the restrictions set forth therein (e.g., restrictions against altering, modifying or copying, or removing the Documentation from Customer’s facility), and further agrees that it will use Products in accordance with the Product Documentation.  Notwithstanding anything to the contrary in the 

 

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Documentation, Specifications, or EULA in the event of inconsistency between the terms and conditions of this Agreement and the term of such documents, the terms and conditions of this Agreement shall supersede and control.  In no event will any such documents [...***...] when such use otherwise complies with this Agreement.  Permitted copies of the Documentation shall include Illumina’s copyright and other proprietary notices. 

 

	
 
	
f.
	
Severability; No Waiver.  If any provision of this Agreement is held invalid or unenforceable, such provision shall be enforced to the maximum extent permissible so as to effect the intent of the Parties, and the remainder of this Agreement will continue in full force and effect.  The failure of either Party to exercise any right granted herein or to require any performance of any term of this Agreement or the waiver by either Party of any breach of this Agreement shall not prevent a subsequent exercise or enforcement of, or be deemed a waiver of any subsequent breach of, the same or any other term of this Agreement.    

 

	
 
	
g.
	
Assignment.  Neither Party may  assign or transfer this Agreement or any rights or obligations under this Agreement, whether voluntary, by operation of law or otherwise, without the prior written consent of the other Party; provided, however, that no consent shall be required for any assignment in connection with any merger, acquisition or the sale of all or substantially all of the stock or assets of a Party to a party that agrees in writing to be bound by the terms and conditions of this Agreement, and Illumina may assign this Agreement to any Affiliate without Customer’s written consent.  Any assignment or transfer of this Agreement made in contravention of the terms hereof shall be null and void.  Subject to the foregoing, this Agreement shall be binding on and inure to the benefit of the Parties’ respective successors and permitted assigns.  

 

	
 
	
h.
	
Export.  Customer agrees that the Consumables, or any related technology provided under this Agreement may be subject to restrictions and controls imposed by the United States Export Administration Act and the regulations thereunder (or the regulations and laws of another country).  Customer agrees not to export or re-export the Consumables, or any related technology into any country in violation of such controls or any other laws, rules or regulations of any country, state or jurisdiction.

 

	
 
	
i.
	
Notices.  All notices required or permitted under this Agreement shall be in writing and shall be deemed received when (i) delivered personally; (ii) 5 days after having been sent by registered or certified mail, return receipt requested, postage prepaid (or 10 days for international mail); or (iii) 1 day after deposit with a commercial express courier specifying next day delivery or, for international courier packages, 2 days after deposit with a commercial express courier specifying 2-day delivery, with written verification of receipt.  All notices shall be sent to the following or any other address designated by a Party using the procedures set forth in this Sub-Section:

 

		
	
If to Illumina:

 

 

Legalnotices@illumina.com
	
If to Customer:

 

Foundation Medicine, Inc.

150 Second Street

Cambridge, MA 02141

Attn:  President and Chief Operating Officer

 

With a copy to:

 

Foundation Medicine, Inc.

150 Second Street

Cambridge, MA 02141

Attn:  General Counsel

 

 

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j.
	
Force Majeure. Neither Party shall be responsible for any failure to perform or delay in the performance of this Agreement attributable in whole or in part to any cause beyond its reasonable control, including but not limited to acts of God, fire, flood, tornado, earthquake, hurricane, lightning, government actions, actual or threatened acts of war, terrorism, civil disturbance or insurrection, sabotage, labor shortages or disputes [...***...], failure or delay in delivery by Illumina’s suppliers or subcontractors, transportation difficulties, shortage of energy, raw materials or equipment, or the other Party’s fault or negligence (a “Force Majeure Event”).  In the event of any delay caused by a Force Majeure Event, the delivery date for performance shall be deferred for a period equal to the time lost by reason of the delay.  Notwithstanding anything in this Agreement to the contrary, Customer’s payment obligations are not affected by this provision.

 

	
 
	
k.
	
Entire Agreement; Amendment; Waiver. This Agreement represents the entire agreement between the Parties regarding the subject matter hereof and supersedes all prior discussions, communications, agreements, and understandings of any kind and nature between the Parties.  No amendment to this Agreement will be effective unless in writing and signed by both Parties.  No waiver of any right, condition, or breach of this Agreement will be effective unless in writing and signed by the Party who has the right to waive the right, condition or breach and delivered to the other Party.  Customer agrees that  (i) actual knowledge by Illumina, Illumina’s Affiliates, or their respective directors, officers, employees, or agents that Customer is using Product in any manner or for any purpose outside the scope of the rights expressly granted to Customer in Section 3 (Rights Accompanying Purchase) does not (A) waive or otherwise limit any rights that Illumina, or Illumina’s Affiliates, may have as a result of such use of the Product, including without limitation, any rights or remedies available under the terms and conditions of this Agreement, and any rights or remedies available at law or in equity, (B) grant Customer a license to any intellectual property owned or controlled by Illumina or Illumina’s Affiliates whether by implication, estoppel, or otherwise with respect to such use of the Product, and (ii) any trade usage, and any course of performance or course of dealing between Illumina and Customer, will not be used to interpret the terms and conditions of this Agreement, including without limitation, the scope of the rights for Product conferred under Section 3 (Rights Accompanying Purchase).

 

	
 
	
l.
	
Relationship of the Parties; No Third-Party Beneficiaries.  The Parties are independent contractors under this Agreement and nothing contained in this Agreement shall be construed as creating a partnership, joint venture or agency relationship between the Parties or, as granting either Party the authority to bind or contract any obligation in the name of the other Party, or to make any statements, representations, warranties or commitments on behalf of the other Party.  

  

	
 
	
m.
	
Publicity; Use of Names or Trademarks; Disclosure of Agreement.  Each Party shall obtain the prior written consent of the other on all press releases or other public announcements relating to this Agreement, including its existence or its terms; provided that, Customer may issue a press release relating to the execution of this Agreement promptly following the Effective Date, the form and substance of which shall be mutually agreed upon by the Parties.  Notwithstanding any of the foregoing, if required by law, including without limitation by the U.S. Securities and Exchange Commission or any stock exchange or Nasdaq, then a Party may issue a press release or other public statement regarding this Agreement or file a copy of this Agreement as an exhibit to a public filing; provided that, the other Party has received prior written notice of such intended press release, public statement or disclosure and an opportunity to seek a protective order or confidentiality treatment if practicable under the circumstances and the right to propose redactions to this Agreement if it is to be filed as an exhibit to a public filing and such proposals not to be unreasonably refused, and the Party subject to the requirement cooperates with the other Party to limit the disclosure and includes in such press release, public statement or disclosure only to the minimum amount of information relating to this Agreement as is required by such law.  Except as required by applicable law or regulations, neither Party shall use the name or trademarks of the other Party without the express prior written consent of the other Party.

 

 

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n.
	
Headings; Interpretation; Miscellaneous.  Sections, titles and headings in this Agreement are for convenience only and are not intended to affect the meaning or interpretation hereof.  This Agreement has been negotiated in the English language.  Any translation is for convenience only.  Only the English language version shall control.  Whenever required by the context, the singular term shall include the plural, the plural term shall include the singular, and the gender of any pronoun shall include all genders.  As used in this Agreement except as the context may otherwise require, “include”, “includes”, “including”, and “such as” are deemed to be followed by “without limitation”, whether or not they are in fact followed by such words or words of like import, and “will” and “shall” are used synonymously.  Except as expressly stated, any reference to “days” shall be to calendar days, and “business day” shall mean all days other than Saturdays, Sundays or a national or local holiday recognized in the United States, and any reference to “calendar month” shall be to the month and not a 30 day period, and any reference to “calendar quarter” shall mean the first 3 calendar months of the year, the 4-6th calendar months of the year, the 7-9th calendar months of the year, and the last 3 calendar months of the year.  Whenever the last day for the exercise of any privilege or the discharge of any duty hereunder shall fall on a Saturday, Sunday, or national holiday, the Party having such privilege or duty shall have until 5:00 pm PST on the next succeeding business day to exercise such privilege or to discharge such duty.  It is further agreed that no usage of trade or other regular practice between the Parties hereto shall be used to interpret or alter the terms of this Agreement.  Ambiguities, if any, in this Agreement shall not be construed against any particular Party, irrespective of which Party may be deemed to have authored the ambiguous provision.  Illumina is constantly innovating and developing new products or new versions of products.  If specific products are listed in this Agreement, Illumina is not guaranteeing that the specific products will be manufactured throughout the Term.  

 

	
 
	
o.
	
Counterparts.  This Agreement may be executed in one or more counterparts, and each of which shall be deemed to be an original, and all of which shall constitute one and the same instrument.

 

 

 

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their respective duly authorized representatives. 

 

Customer:  Illumina:

 

 

By:  /s/ Jason Ryan      By: /s/ Jeffrey S. Eidel

 

Name: Jason Ryan                                                            Name:Jeffrey S. Eidel

 

Title: Chief Financial Officer                                        Title:VP, Corporate & Business Development

 

Date:    June 6, 2018      Date:   June 6, 2018

Signature Page to Amended and Restated Supply, Service, and Support Agreement

***Confidential Treatment Requested***

 

 

Exhibit A

[...***...]

 

[...***...]

 

		
	
[...***...]
	
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[...***...]
	
[...***...]

	
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[...***...]

 

						
	
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[...***...]

 

 

***Confidential Treatment Requested*** 

 

 

Exhibit A-1

[...***...]

 

 

[...***...]

				
	
[...***...]
	
[...***...]
	
[...***...]
	
[...***...]

	
[...***...]
	
[...***...]
	
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[...***...]

 

 

				
	
[...***...]
	
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[...***...]

 

				
	
[...***...]
	
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[...***...]

	
[...***...]
	
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[...***...]

 

***Confidential Treatment Requested***

 

 

				
	
[...***...]
	
[...***...]
	
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[...***...]

	
[...***...]
	
[...***...]
	
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[...***...]

	
[...***...]
	
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[...***...]

 

					
	
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[...***...]

 

 

		
	[...***...][...***...][...***...][...***...][...***...][...***...][...***...][...***...][...***...][...***...][...***...][...***...][...***...][...***...]
 
	
 

 

***Confidential Treatment Requested***

 

 

Appendix I

Service Contract Terms and Conditions

 

Illumina’s Service Contracts are subject to the following terms, conditions, and limitations.

 

	
 
	
1.
	
Definitions. “Covered Hardware” means those portions of the Hardware that are covered by a Service Contract purchased by Purchaser hereunder.  “Current Specifications” means Seller’s written specifications for the Covered Hardware that apply to such Covered Hardware as provided in the Service Contract that is purchased hereunder, but only if the purchased Service Contract provides that the Covered Hardware will conform to current specifications rather than the Original Specifications.  “Purchaser” means the person or entity acquiring the Service Contract from Seller (i.e., ‘Customer’ as defined in the Agreement to which this Appendix I is attached).  “Documentation” means Seller’s user manual, package insert, and similar documentation, for the Covered Hardware in effect on the date that such Covered Hardware shipped from Seller.  Documentation may have contained additional terms and conditions that are hereby incorporated herein by reference.  Documentation may have been provided (including by reference to a website) with the Covered Hardware at time of shipment or provided electronically from Seller.  “EULA” means the end user license agreement for Software.  “Facility” means the physical address where Covered Hardware is located.  “Hardware” means Seller branded instruments, accessories, or peripherals.  “Original Specifications” means Seller’s written specifications for the Covered Hardware in effect on the date that such Covered Hardware shipped from Seller.  “Original Terms” means the Seller terms and conditions of sale in effect on the date the Covered Hardware was shipped from Seller setting forth the terms and conditions of Purchaser’s purchase and use of such Covered Hardware, components thereof, and Software.  “Quotation” means a written quotation provided by Seller to Purchaser for the Service Contract. “Seller” means Illumina.  The Selling entity is identified on the quotation, order acknowledgment or similar communication, or Seller website if the order is being placed electronically at Seller’s website.  “Specifications” means the Current Specifications or the Original Specifications, as applicable; provided that, Specifications shall in all cases refer to the Original Specifications unless otherwise set forth in the Service Contract.  “Site” means the smallest definable room that contains the Covered Hardware.  “Software” means Seller branded software provided by Seller with the Covered Hardware.  All Software is licensed and not sold and may be subject to additional terms found in the Software’s end user license agreement.  “Term” means the length of the term of the Service Contract.    

	
 
	
2.
	
Term. All Service Contracts are for a period of 12 months, unless otherwise agreed to in writing by Seller or as set forth in the relevant Quotation.

	
 
	
3.
	
Response Time and On-site Support.  Seller will use commercially reasonable efforts to respond to Purchaser’s requests for service within the time period specified in the Service Contract.  All requests for service must be made through Seller’s customer support organization (“Purchaser Solutions”).  Please refer to Seller’s website for Purchaser Solutions contact information.  Seller reserves the right to provide service and support by any method in its sole discretion, including but not limited to, remote instruction via telephone, Internet or email, mailing to Purchaser replacement parts or test equipment, exchanging Purchaser’s component equipment with loaner equipment while repairs are being made, and deploying service or applications personnel for on-site services.  Other than installation and preventative maintenance visits, Seller shall determine in its sole discretion whether and when any personnel or replacement parts or equipment are to be sent to Purchaser’s site.  Seller shall respond to Purchaser’s request for support in accordance with the average response time specified in the Service Contract.  Seller will provide a minimum number of on-site support visits as specified in the Service Contract if the Purchaser has identified a specific need that can be fulfilled by the visit and if the Purchaser has made reasonable accommodation for scheduling the visit.  If no need is identified and the timing of any visit cannot be scheduled at a mutually-agreeable date and time, Seller may provide fewer visits than prescribed in the Service Contract.

	
 
	
4.
	
Software Support.  During the Term, Seller shall use commercially reasonable efforts to provide all Software updates and qualified Software upgrades in accordance with the terms of the Service Contract as such materials become commercially available for distribution.  Purchaser’s use of all Software, updates, 

 ***Confidential Treatment Requested***

 

 

 

	
 
		
and upgrades of Software shall be subject to this Agreement, the Original Terms, and the applicable EULA. 

	
 
	
5.
	
Hardware Support.  During the Term, Seller shall use commercially reasonable efforts to install mandatory Hardware updates in accordance with the terms of the Service Contract as such materials become available for distribution.  Whether a Hardware update is mandatory shall be determined by Seller in its sole discretion.  Seller shall reschedule Hardware updates to coincide with preventive maintenance visits.  If Purchaser requests that such Hardware updates occur at a time or date other than during preventive maintenance visits, Seller may, at its sole discretion, charge Purchaser for any costs and expenses incurred in connection with such Hardware update visit.  All updated Hardware and components thereof and Purchaser’s use of the same shall be subject to this Agreement and the Original Terms.

	
 
	
6.
	
Hardware Repairs.  Seller shall use commercially reasonable efforts to repair Covered Hardware reported by Purchaser and deemed inoperable by Seller’s Purchaser Solutions personnel.  Seller’s sole obligation hereunder is to provide parts and labor according to the terms of the Service Contract and is limited to only repair or replacement of Seller branded parts originally provided by Seller to Purchaser.  All repaired or replaced items and Purchaser’s use of the Covered Hardware including the repaired or replaced components shall be subject to this Agreement and the Original Terms.  For clarity, repaired or replaced items will be warranted to conform to the Specifications for 90 days from the date of installation or repair of such repaired or replaced item. 

	
 
	
7.
	
Documentation Updates.  Seller shall use commercially reasonable efforts to provide updates to Documentation according to the terms of the Service Contract as they become available for distribution.  Whether a Documentation update is mandatory shall be determined by Seller in its sole discretion.  All updates to Documentation and Purchaser’s use of the Documentation shall be subject to this Agreement and the Original Terms. 

	
 
	
8.
	
Replacement Parts.  All replacement parts and components provided by Seller will be new or refurbished, in Seller’s sole discretion, and shall be furnished on an exchange basis.  All Hardware or components thereof or other parts removed for replacement shall become the property of Seller.  All replaced parts and components and Purchaser’s use of the Covered Hardware including the replaced parts and components shall be subject to this Agreement and the Original Terms.  For clarity, repaired or replaced items will be warranted to conform to the Specifications for [...***...] from the date of installation or repair of such repaired or replaced item.    

	
 
	
9.
	
Loaner Hardware.  Seller may choose to provide, in its sole discretion, loaner hardware or components to Purchaser to substitute for the Covered Hardware or a component thereof, while service is being provided.  Seller will be responsible for all costs associated with the shipment of such loaner hardware or components to Purchaser’s Site, exclusive of any taxes or duties, which are the sole responsibility of Purchaser.  Loaner hardware or components shall be certified by Seller’s Purchaser Solutions using the same criteria as used for new hardware or components.  Loaner hardware or components shall remain the sole property of Seller, and must be returned within 30 days of Seller’s request.  Purchaser’s use of loaner hardware or components shall be subject to Seller’s current terms and conditions of sale that apply to such loaner hardware or component. 

	
 
	
10.
	
Preventative Maintenance Visits.  Seller will provide a preventative maintenance on-site visit according to the terms of the Service Contract, which may result in two to three days of system down time to Purchaser.  Seller shall cooperate with Purchaser to schedule such preventative maintenance visits at a time that is mutually convenient for both Parties.  All such preventative maintenance services will be provided by Seller designated service personnel.  All travel, labor and parts/materials expenses associated with prescribed preventative maintenance visits, visits to service, repair or replace covered items, and applications support visits as provided for in the Service Contract  are included in the price set forth for such Service Contract.  Preventative maintenance services include testing and adjusting the Covered Hardware to the Specifications.  If any preventative maintenance visit within the Term is precluded due to Purchaser’s inability to provide a sufficient time period for such services and down time, Seller shall not be obligated to provide a substitute preventative maintenance visit.  Seller shall not be liable for any economic, consequential, incidental, special or other damages or losses of any kind resulting from the down time during such preventative maintenance visits. 

	
 
	
11.
	
Purchaser Responsibilities.  

 ***Confidential Treatment Requested***

 

 

 

	
 
	
a.
	
Proper Use:  The performance of Covered Hardware when operated in corrosive environments, or in conditions, or in a manner, outside of the Specifications including Seller’s site requirements found in the Documentation or not in accordance with its Documentation may have their performance adversely affected, and are therefore not guaranteed hereunder.  The Purchaser agrees to use the Covered Hardware in a safe and reasonable manner pursuant to the Documentation and the Original Terms.  

	
 
	
b.
	
Access:  The Purchaser will provide Seller with access to the Covered Hardware along with adequate working space and facilities within a reasonable distance of the Covered Hardware.  Access will also be provided to all information and facilities that are reasonably necessary for Seller to service the Covered Hardware.

	
 
	
c.
	
Data Back-up and Security:  The Purchaser is responsible for maintaining a procedure to reconstruct any lost or altered files, data, or programs, as well as for the security of all confidential, proprietary, and classified information.  

	
 
	
d.
	
Networking:  The Purchaser is responsible for maintaining all computer networking as it relates to the integration of any components of the Covered Hardware outside of such system and within the Purchaser’s network.

	
 
	
e.
	
Representative:  A representative of Purchaser will be present on-site at all times service is being performed by Seller’s designated service personnel.

	
 
	
f.
	
Toxic/BioHazardous Substances:  The Purchaser will notify Seller in writing if any Covered Hardware is used for analysis of toxic, hazardous or dangerous substances.  Such Covered Hardware must be decontaminated by Purchaser in accordance with Seller’s decontamination procedures and Purchaser shall fax a completed and executed Decontamination Certificate to Purchaser Solutions before any service may be performed on the Covered Hardware.

	
 
	
g.
	
Environment:  The Purchaser agrees to provide Seller’s designated service personnel with a safe environment for their work.  

	
 
	
h.
	
Disposal of Waste Products:  The Purchaser is responsible for the proper disposal of waste products that result from maintenance and service work on the Covered Hardware.

	
 
	
i.
	
Facilities:  The Purchaser is responsible for ensuring that the Site will adhere to Seller’s site requirements found in the Documentation or Specifications.  Any material deviation from Seller’s site requirements affecting the proper functioning of the Covered Hardware shall relieve Seller of its obligations under this Agreement, including without limitation, under the Service Contract.

	
 
	
12.
	
Exclusions and Restrictions.  The terms of this Agreement cover maintenance and repair for conditions that result from normal use and operation as described in the Documentation for the Covered Hardware.  Seller will not be obligated to perform maintenance or repair on any Covered Hardware which, in its reasonable judgment:

	
 
	
a.
	
Has been subjected to abuse, misuse, neglect, negligence, accident, improper testing, improper installation other than installation performed by Seller authorized personnel, improper storage, improper handling, or use contrary to any instructions issued by Seller or has been used in any manner inconsistent with its Documentation: 

	
 
	
b.
	
Has been repaired, altered, disassembled, reassembled, or damaged as a result of modifications made to the Covered Hardware that were not authorized in writing by Seller;

	
 
	
c.
	
Has been damaged by environmental conditions at the Site;

	
 
	
d.
	
Has not been installed, operated, repaired and maintained in accordance with its Documentation or has been damaged due to operators failing to perform standard operating procedures or routine maintenance as prescribed in the applicable Documentation;

	
 
	
e.
	
Has been moved from the Site by persons not expressly authorized in writing by Seller;

	
 
	
f.
	
Has been used with any third-party software, hardware, or item including, without limitation, reagent which has not been previously approved in writing by Seller;

	
 
	
g.
	
Has been exposed to Bio-safety Level 3 or 4 agents (as defined by The Occupational Safety and Health Administration);

	
 
	
h.
	
Has been exposed to radioactivity, and has not been decontaminated to below exempt levels; or

	
 
	
i.
	
Has been damaged due to an act of Force Majeure as defined herein.

	
 
	
13.
	
Services by Third Parties on Seller’ Behalf.  Seller reserves the right to retain or contract outside vendors of its choosing to provide service and support hereunder.  In any instance where the terms and 

 ***Confidential Treatment Requested***

 

 

 

	
 
		
conditions of such vendor’s service, support, and warranty agreement conflicts with the terms and conditions of this Agreement, the terms and conditions of this Agreement shall govern; provided, however that any exclusions on coverage contained in an OEM vendor’s terms and conditions shall remain in full force and effect.  

	
 
	
14.
	
Relocation of Hardware.  All Service Contracts terminate automatically with immediate effect and without the need for notice to Purchaser if Covered Hardware is moved to a different Facility. Upon such termination, Seller will credit Purchaser’s account with Seller an amount equal to the unused portion of the Service Contract; provided that, Purchaser pre-paid for the Service Contract in full.  If Seller (or a third party acting on behalf of Seller) conducts the move of the Covered Hardware on Purchaser’s behalf then Seller and Purchaser will enter into a new Service Contract for such Covered Hardware at the new Facility. 

	
 
	
15.
	
Export of Hardware.  Purchaser agrees not to move or relocate Covered Hardware outside of the country to which Seller originally shipped it without the express written authorization of an officer of Seller; provided that a conduct of the move or relocation of the Covered Hardware by Seller (or a third party acting on behalf of Seller) shall be deemed such express written authorization.

	
 
	
16.
	
Recertification Requirement. Hardware not under an existing Service Contract is only eligible for a Service Contract if Seller has inspected the Hardware and its ancillary equipment and provided a written notice to Purchaser that the Hardware is eligible for a Service Contract (“Recertification Requirement”).  Purchaser acknowledges that Hardware may have to be repaired, at Purchaser’s sole expense, prior to being eligible for a Service Contract.  Accordingly, Seller recommends that Purchaser renew its existing Service Contracts prior to their expiration.

	
 
	
17.
	
Renewal of Service Contract.  If Purchaser renews the Service Contract on a piece of Covered Hardware prior to the expiration of the Service Contract Seller will waive the Recertification Requirement.

	
 
	
18.
	
Early Termination of Service Contract.  Purchaser or Seller may, in their sole discretion, terminate the Service Contract early by providing 30 days prior written notice to the other.  Upon such termination, Seller will credit Purchaser’s account with Seller an amount equal to the unused portion of the Service Contract; provided that, Purchaser pre-paid for the Service Contract in full; and provided further that, the amount of such credit will be reduced by the amount of any discount Seller provided Purchaser as a result of Seller purchasing a multi-year Service Contract (“Unearned Discount”).  In the event Purchaser’s Unearned Discount exceeds the amount of credit that Seller would provide under this provision, Seller will invoice Purchaser the difference and such invoice shall be paid within 30 days.

	
 
	
19.
	
Non-Transferable.  All Service Contracts are personal to the original Purchaser of the Covered Hardware and may not be transferred or assigned to any third party.  

	
 
	
20.
	
Force Majeure.  Seller is not responsible for any failure to perform or delay attributable in whole or in part to any cause beyond its reasonable control, including but not limited to acts of God, fire, flood, tornado, earthquake, hurricane, lightning, government actions, actual or threatened acts of war, terrorism, civil disturbance or insurrection, sabotage, labor shortages or disputes, failure or delay in delivery by Seller’s suppliers or subcontractors, transportation difficulties, shortage of energy, raw materials or equipment, or Purchaser’s fault or negligence.  In the event of any such delay the delivery date shall be deferred for a period equal to the time lost by reason of the delay.  

	
 
	
21.
	
Unauthorized Activities.  Purchaser agrees not to, nor authorize any third party to, engage in any of the following activities: (i) disassemble, reverse-engineer, reverse-compile, or reverse-assemble the Covered Hardware or an items provided hereunder (collectively “Materials”), (ii) separate, extract, or isolate components of the Materials or subject the Materials or components thereof to any analysis not expressly authorized in the Documentation, (iii) gain access to or attempt to determine the methods of operation of the Materials, or (iv) transfer to a third party, or grant a sublicense to, any Software or any third-party software provided hereunder.  Purchaser further agrees that the contents of and methods of operation of the Materials are proprietary to Seller and the Materials contains or embodies trade secrets of Seller.  

	
 
	
22.
	
Limited Liability.  TO THE EXTENT PERMITTED BY LAW, IN NO EVENT SHALL SELLER OR ITS SUPPLIERS BE LIABLE TO PURCHASER OR ANY THIRD PARTY FOR COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS OR SERVICES, LOST PROFITS, DATA OR BUSINESS, OR FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH, WITHOUT LIMITATION, THE SALE OF THE COVERED 

 ***Confidential Treatment Requested***

 

 

 

	
 
		
HARDWARE OR SERVICE CONTRACT, THE USE OF THE COVERED HARDWARE, THE ITEMS AND SERVICES PROVIDED HEREUNDER, SELLER’S PERFORMANCE HEREUNDER OR ANY OF THESE TERMS AND CONDITIONS, HOWEVER ARISING OR CAUSED AND ON ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE).

 

TO THE EXTENT PERMITTED BY LAW, SELLER’S TOTAL AND CUMULATIVE LIABILITY TO PURCHASER OR ANY THIRD PARTY ARISING OUT OF OR IN CONNECTION WITH THESE TERMS AND CONDITIONS, INCLUDING WITHOUT LIMITATION, THE COVERED HARDWARE OR ITEMS PROVIDED HEREUNDER (INCLUDING USE THEREOF), THE SERVICE CONTRACT, THE SERVICES PROVIDED HEREUNDER, AND SELLER’S PERFORMANCE HEREUNDER, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE, SHALL IN NO EVENT EXCEED [...***...]. 

 

	
 
	
23.
	
Limitations on Warranties.  TO THE EXTENT PERMITTED BY LAW AND SUBJECT TO THE EXPRESS WARRANTIES MADE IN THESE TERMS AND CONDITIONS SELLER MAKES NO (AND EXPRESSLY DISCLAIMS ALL) WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, WITH RESPECT TO THE COVERED HARDWARE, THE ITEMS PROVIDED HEREUNDER, THE SERVICE CONTRACTS, AND THE SERVICES PROVIDED HEREUNDER, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR ARISING FROM COURSE OF PERFORMANCE, DEALING, USAGE OR TRADE. 

 

 

 ***Confidential Treatment Requested***

 

 

 

Exhibit B

Ordering Affiliates

 

 

FMI Germany GmbH

***Confidential Treatment Requested***fmi-ex102_169.htm

Exhibit 10.2

***Text Omitted and Filed Separately with the Securities and Exchange Commission 

Confidential Treatment Requested Under 

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Execution Version

 

 

CHINA TERRITORY AGREEMENT

 

This China Territory Agreement (“Agreement”) is entered into by and between F. Hoffmann-La Roche Ltd, with an office and place of business at Grenzacherstrasse 124, 4070, Basel, Switzerland (“Roche”), on the one hand, and Foundation Medicine, Inc. with an office and place of business at 150 Second Street, Cambridge, MA 02141, U.S.A. (“FMI”), on the other hand (each a “Party,” and collectively, the “Parties”) and shall take effect as of April 26, 2018 (the “Effective Date”). Capitalized terms used in this Agreement and not otherwise defined herein are used with the meanings ascribed to them in the Ex-US Commercialization Agreement (as defined below).

 

WHEREAS, the Parties have entered into the Amended and Restated Ex-US Commercialization Agreement, dated as of February 28, 2018 (as it may be amended from time to time, the “Ex-US Commercialization Agreement”), pursuant to which FMI has agreed to perform certain Service Activities to support Roche’s commercialization of the First Year Products in the Territory; and

 

WHEREAS, in recognition of certain legal and regulatory considerations applicable to the People’s Republic of China, excluding Hong Kong, Taiwan, and Macau (the “China Territory”), which is included in the Territory, the Parties intend to modify the terms and conditions of the Ex-US Commercialization Agreement as-applied to the China Territory and agree upon certain additional terms and conditions for the purpose of establishing a collaboration with DiAn Diagnostics Group Co., Ltd. (“DiAn”) for the purpose of implementing such Ex-US Commercialization Agreement in the China Territory (the “Collaboration”);

 

NOW, THEREFORE, in consideration of the above, and of the mutual covenants and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

 

1.Purpose of this Agreement.  For the purpose of implementing the Ex-US Commercialization Agreement in the China Territory, according to that certain Commercialization and Services Agreement by and between Roche and DiAn, dated as of the Effective Date (as it may be amended from time to time, the “Commercialization and Services Agreement”), and that certain Technology License and Laboratory Services Agreement entered into by and between FMI and DiAn, dated as of the Effective Date (as it may be amended from time to time, the “Laboratory Services Agreement”), the Parties agree that DiAn shall perform (A) certain commercialization activities in the China Territory for First Year Products on Roche’s behalf for the purpose of implementing the 

***Confidential Treatment Requested***

Collaboration in accordance with the Commercialization and Services Agreement, and (B) all Service Activities specified by FMI in the China Territory for the First Year Products on FMI’s behalf for the purpose of implementing the Collaboration in accordance with the Laboratory Services Agreement.  

 

 

2.Terms Specific to Commercialization and Services Agreement.

 

2.1.FMI Consent to Sublicense.  FMI hereby consents to the grant by Roche of the sublicense to DiAn as set forth in the Commercialization and Services Agreement, subject to Sections 2.1.2 (Sublicenses) and 19.15 (Subcontractors) of the Ex-US Commercialization Agreement, in order for DiAn to conduct the services contemplated thereby in order to commercialize the First Year Products in the China Territory.   In addition, FMI hereby agrees that the [...***...] audit provision in Section 11.4 (Duration of Audit Rights) of the Commercialization and Services Agreement shall limit FMI’s audit rights under Sections 11.4 (Duration of Audit Rights) and 11.1 (Right to Audit) of the Ex-US Commercialization Agreement, solely to the extent set forth in Section 11.4 of the Commercialization and Services Agreement in effect as of the Effective Date.  To the extent that there are any other conflicts between any term or condition of the Commercialization and Services Agreement and any term or condition of the Ex-US Commercialization Agreement such that both cannot be given effect, the relevant term or condition of the Commercialization and Services Agreement shall prevail solely with regard to matters relating to the China Territory.  Notwithstanding the foregoing: (a) the preceding sentence shall not apply to any amendments, waivers, or other modifications to the Commercialization and Services Agreement following the Effective Date of this Agreement that FMI has not approved in advance in writing; (b) the preceding sentence shall not apply to the definition of “Product” as set forth in the Commercialization and Services Agreement (i.e., each “Product” definition shall be interpreted as it is used in the relevant agreement); and (c) nothing in this Agreement or in the Commercialization and Services Agreement shall limit any of Roche’s obligations or FMI’s rights under Article 4 (Governance), Section 7.4.1 (Roche Responsibilities), Section 7.5 (Branding and Pricing) as it applies to branding (pricing in the China Territory is determined by [...***...]), Section 7.6 (Product Promotional Materials and Promotional Obligations), Article 12 (Intellectual Property), Article 14 (Indemnification), or Article 15 (Liability) of the Ex-US Commercialization Agreement, except as may otherwise be expressly agreed upon by FMI and Roche in writing.

 

2.2.Grant of Rights.  Roche hereby grants to FMI a non-exclusive, worldwide, royalty-free, sublicensable license under Roche’s interest in any DiAn-Licensed IP solely for the purpose of making, having made, using, selling, offering for sale or importing Products.  For the purpose of this Section 2.2, “DiAn-Licensed IP” shall mean any Patent Rights (as defined in the Commercialization and Services Agreement) and Know-How (as defined in the Commercialization and Services Agreement) generated by DiAn in the performance of its activities under the Commercialization and Services Agreement that is licensed to Roche pursuant to Section 2.1.1. thereof.

Page 2 of 12

***Confidential Treatment Requested***

 

 

2.3.Effect of Termination.  

 

(A)In the event that either (i) Roche exercises any of its termination rights under the Commercialization and Services Agreement prior to the expiration of the term thereof other than following DiAn’s termination of the Laboratory Services Agreement upon FMI’s material breach thereof (either in whole, or with respect to a particular First Year Product); or (ii) DiAn terminates the Commercialization and Services Agreement due to Roche’s material breach thereof (each of (A)(i) and (A)(ii), a “Territory Reduction Event”), then upon FMI’s delivery of written notice that the relevant Territory Reduction Event has taken place (the “Territory Reduction Notice”), the Territory shall be revised to remove the China Territory in its entirety from the Territory or to remove a particular First Year Product (as applicable) from the China Territory, as the case may be, and the China Territory shall be deemed to be included in the FMI Territory, either in whole or with respect to the particular First Year Product in question (as applicable).  For clarity, upon removal of the China Territory from the Territory pursuant to FMI’s delivery of the Territory Reduction Notice to Roche following the occurrence of a Territory Reduction Event, the relevant licenses and rights granted to Roche under the Ex-US Commercialization Agreement shall automatically terminate on the effective date of termination and with respect to any applicable First Year Products, and FMI shall have the sole right to commercialize any such Product in the China Territory.

 

(B)Notwithstanding anything to the contrary in the Ex-US Commercialization Agreement, Roche will: 

 

	
 
	
(i)
	
following (a) the occurrence of a Territory Reduction Event or (b) the expiration or termination (whether in whole, with respect to the China Territory, or with respect to each particular First Year Product in question, as applicable) of the Ex-US Commercialization Agreement (each of (B)(i)(a) and (B)(i)(b) of this Section 2.3, a “Termination Event”), continue to provide the Roche Services as set forth in the Commercialization and Services Agreement for a period of [...***...] months (either for all First Year Products, or with respect to each particular First Year Product in question, as the case may be);

 

	
 
	
(ii)
	
perform the activities described in Sections 17.3.1(b)-(d) and 17.3.4.1 of the Ex-US Commercialization Agreement for a period of [...***...] months following the occurrence of a Termination Event (either for all First Year Products, or with respect to each First Year Product in question, as the case may be); 

 

	
 
	
(iii)
	
the occurrence of a Termination Event shall not excuse either Party from any of its obligations under this Agreement or the Ex-US Commercialization Agreement (as it relates to the China Territory), in each case, which were in existence prior to such Termination Event; 

Page 3 of 12

***Confidential Treatment Requested***

 

 

	
 
	
(iv)
	
without limiting the generality of clause (iii) immediately above, Roche’s obligations pursuant to Section 3.2 (Defense Against Third-Party Infringement Claims) shall survive the occurrence of a Termination Event with respect to any Third-Party Infringement Suits (as defined below) commenced prior to such Termination Event; and

 

	
 
	
(v)
	
(a) to the extent that such Termination Event results in the termination of the Commercialization and Services Agreement with respect to the FoundationOne Product, Roche shall make a payment of [...***...] United States dollars         (US$[...***...]) to FMI, (b) to the extent that such Termination Event results in the termination of the Commercialization and Services Agreement with respect to FoundationOne Heme  Roche shall make a payment of [...***...] United States dollars (US$[...***...]) to FMI, and (c) to the extent that such Termination Event results in the termination of the Commercialization and Services Agreement with respect to FACT, Roche shall make a payment of [...***...] United States dollars (US$[...***...]) to FMI, in each case of (a)-(c), within [...***...] days following Roche’s receipt of notice from FMI stating that the relevant Termination Event has occurred.

 

	
 
	
(vi)
	
For clarity, to the extent that a Termination Event results in the termination of the Commercialization and Services Agreement with respect to all First Year Products, Roche shall make a payment of [...***...] United States Dollars (US$[...***...]) to FMI within [...***...] days following Roche’s receipt of notice from FMI stating that the relevant Termination Event has occurred; provided, however, if Roche at the time of the Termination Event is selling Product in the China Territory, then no payment shall be payable under Section 2.3(B)(v) or this Section 2.3(B)(vi).

 

2.4.Non-Commercial Clinical Reports.  The JSC (as defined in the Laboratory Services Agreement and the Commercialization and Services Agreement) will make express determinations as to circumstances under which Non-Commercial Clinical Reports (as defined in the Laboratory Services Agreement and the Commercialization and Services Agreement) may be issued by DiAn in the China Territory at Roche’s request, provided that: (A) Roche will have final decision-making authority (upon reasonable consultation with FMI) with respect to any such determinations that have not been expressly reviewed and approved by the JOC (as defined under the Ex-US Commercialization Agreement) in accordance with Article 6 of the Laboratory Services Agreement and Article 4 (Governance) of the Commercialization and Services Agreement; and (B) Roche shall account for each Non-Commercial  Clinical Report issued in the China Territory as set forth under Section 3.5 (Royalties for the China Territory) below.  Notwithstanding anything to the contrary in the Ex-US Commercialization Agreement, FMI shall have no financial obligations to Roche or DiAn with respect to any Non-Commercial Clinical Reports issued by 

Page 4 of 12

***Confidential Treatment Requested***

 

DiAn in accordance with this Agreement and any guidance or policies for such Non-Commercial Clinical Reports established by the JSC.

 

 

	
3.
	
Implementation of the Ex-US Commercialization Agreement in the China Territory.

 

3.1.Roche Assistance with FMI Intellectual Property Matters in China.  

 

	
 
	
(A)
	
Enforcement of FMI’s Intellectual Property Rights. During the Agreement Term, to the extent that Roche is commercializing any First Year Products in the China Territory, (A) FMI shall have the right, but not the obligation, to request that Roche enforce FMI’s intellectual property rights in the China Territory for any such First Year Products (collectively, “FMI China IP”) at [...***...] sole cost and (B) to the extent Roche has knowledge of any infringement or misappropriation of FMI China IP, Roche shall promptly provide written notice of such infringement or misappropriation to FMI.  To the extent that FMI exercises such right with respect to the enforcement of any FMI China IP, Roche will use reasonable efforts to enforce the relevant FMI China IP in a timely manner.  Notwithstanding the foregoing, for clarity, FMI shall always have the right to enforce any FMI China IP at its own discretion [...***...].   

 

	
 
	
(B)
	
Challenges to Third Party Intellectual Property Rights.  During the Agreement Term, to the extent that Roche is commercializing any First Year Products in the China Territory, [...***...] will, upon [...***...] request and at [...***...], provide reasonable assistance with any [...***...] that [...***...] initiates, whether at [...***...] request or at [...***...] sole discretion.  In addition,  [...***...] will be permitted to initiate an [...***...] at its own discretion; provided that [...***...] shall be required to provide [...***...] with reasonable advance notice of its intention to initiate any such [...***...] and will consider in good faith [...***...] reasonable comments regarding the advisability of such [...***...] prior to [...***...] initiation thereof, as well as the general strategy associated with such [...***...] (including which Party initiates and controls such [...***...]) if applicable.  Subject to the preceding sentence, [...***...] if an [...***...] is initiated at [...***...] request or discretion, [...***...] shall be solely responsible for [...***...] (excluding any [...***...]) associated therewith; provided, however, that, where [...***...]: (a) [...***...] shall only be responsible for up to [...***...] United States dollars (US$[...***...]) (the “[...***...] Cap”) in aggregate costs and expenses associated with all [...***...] during the Collaboration Term (as defined under Section 3.3(A) below); and (b) [...***...] will  be solely responsible for any costs or expenses in excess of the [...***...] Cap associated with [...***...] during the Collaboration Term.  Notwithstanding anything in this Agreement to the contrary, the term [...***...] shall not include any [...***...], to the extent that such proceeding or 

Page 5 of 12

***Confidential Treatment Requested***

 

	
 
		
process is initiated after a Third Party commences (y) any Third-Party Infringement Suit (as defined under Section 3.2(A) below) against either Party in connection with such patent(s) or (z) any Third-Party Infringement Suit (as defined under Section 11.6 of the Laboratory Services Agreement) against [...***...] in connection with such patent(s), and any such proceeding or process, if applicable, shall be governed by the terms and provisions of Section 3.2 (Defense Against Third-Party Infringement Claims) below.

 

3.2.Defense Against Third-Party Infringement Claims.   

 

(A)Defense Procedure.  If an action for infringement is commenced against either Party or any of its Affiliates asserting that such Party’s performance of its obligations arising out of or relating to this Agreement or the Collaboration infringes the intellectual property rights of a Third Party (a “Third-Party Infringement Suit”), such Party or its Affiliate (as a “Defending Party”) shall defend such Third-Party Infringement Suit at its own expense, and the other Party shall reasonably assist and cooperate with the Defending Party, at its own expense, to the extent necessary in the defense of such Third-Party Infringement Suit.  The Defending Party shall have the right to settle such Third-Party Infringement Suit or consent to a judgment thereto, in its sole discretion, so long as such settlement or judgment does not adversely affect the rights of the other Party or its Affiliates (including any patent rights Controlled by any of them), including by entering into a settlement agreement or consenting to a judgment constituting an admission of the invalidity of any patent rights Controlled by any of them (including, in the case of FMI, any FMI Patent Rights or any of FMI’s patent rights outside of the Territory).  Where a settlement or judgment to any such Third-Party Infringement Suit would adversely affect the rights of the other Party or its Affiliates (including any patent rights Controlled by any of them), the Defending Party shall not settle such Third-Party Infringement Suit or consent to an adverse judgment thereto without the other Party’s prior written consent.  The Defending Party shall incorporate the other Party’s reasonable comments into any filings made by the Defending Party in connection with the defense of any such Third-Party Infringement Suit.  The Defending Party shall assume full responsibility for the payment of any award for damages, or any amount due pursuant to any settlement entered into by it and the Third Party that commenced the relevant Third-Party Infringement Suit against it.  If a Third-Party Infringement Suit is commenced against all of FMI, Roche, and DiAn (or, in each case, any of its respective Affiliates) in connection with the Parties’ performance of their respective obligations relating to this Agreement or the Collaboration, and DiAn’s performance of its obligations under the Collaboration, the Laboratory Services Agreement, or the Commercialization and Services Agreement, then the Parties and DiAn, through the JSC, shall discuss in good faith how control of the defense of any such Third-Party Infringement Suit shall be handled.  

 

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(B)Allocation of IP Losses.  Notwithstanding anything to the contrary in this Agreement or the Ex-US Commercialization Agreement, the Parties agree to allocate any and all IP Losses (as defined below) in accordance with Table 1- IP Loss Tiers below.

 

Table 1- IP Loss Tiers

 

			
	
IP Loss Tier 
	
FMI Cost Share
	
Roche Cost Share

	
Tier 1

Aggregate IP Losses up to and including US$[...***...]
	
[...***...]% 
	
[...***...]% 

	
Tier 2

Aggregate IP Losses from US$[...***...] to US$[...***...]
	
[...***...]% 
	
[...***...]% 

	
Tier 3

Aggregate IP Losses from US$[...***...] to US$[...***...]
	
[...***...]% 
	
[...***...]% 

	
Tier 4

Aggregate IP Losses in excess of US$[...***...]
	
[...***...]%
	
[...***...]%

 

 

With respect to any IP Losses within a given IP Loss Tier, Roche shall reimburse FMI for Roche’s share of such IP Losses in accordance with the Roche Cost Share applicable to such IP Loss Tier (as set forth in Table 1- IP Loss Tiers).  

 

For example, if FMI were to incur US$[...***...] in IP Losses during a Calendar Quarter, and had not incurred any IP Losses prior to such Calendar Quarter, Roche’s reimbursement to FMI for IP Losses incurred by FMI during such Calendar Quarter would be calculated as follows:

 

[US$[...***...]] + [US$[...***...]] = US$[...***...].

 

If FMI were to incur US$[...***...] in IP Losses during a Calendar Quarter, and had incurred US$[...***...] in aggregate IP Losses prior to such Calendar Quarter, Roche’s reimbursement to FMI for IP Losses incurred by FMI during such Calendar Quarter would be calculated as follows:

 

[US$[...***...]] + [US$[...***...]] = US$[...***...].

 

If FMI were to incur US$[...***...] in IP Losses during a Calendar Quarter, and had incurred US$[...***...] in aggregate IP Losses prior to such Calendar Quarter, Roche’s reimbursement 

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to FMI for IP Losses incurred by FMI during such Calendar Quarter would be calculated as follows:

 

[US$[...***...]] = US$[...***...].

 

Promptly following the end of each Calendar Quarter, FMI shall invoice Roche for Roche’s share of any IP Losses to be reimbursed by Roche (if any) in connection with IP Losses incurred by FMI during such Calendar Quarter. Each invoice shall include reasonable supporting documentation relating to the IP Losses.  Roche shall make payment on each such invoice within [...***...] calendar days following its receipt thereof.

 

“IP Losses” shall mean any and all costs, liabilities, fees, expenses, fines, damages, judgments, penalties, and other out of pocket amounts incurred by FMI (excluding any internal FMI costs): (i) in connection with FMI’s defense (whether sole or joint) against Third-Party Infringement Suits; or (ii) pursuant to FMI’s obligation to indemnify DiAn and other “DIAN Indemnitees” (as defined in the Laboratory Services Agreement) against Indemnifiable Losses (as defined in the Laboratory Services Agreement) arising from Third-Party Infringement Claims (as defined in the Laboratory Services Agreement) under Section 15.1.2 of the Laboratory Services Agreement.

 

3.3.Obligations of FMI Satisfied by DiAn.  Notwithstanding anything to the contrary in the Ex-US Commercialization Agreement:

 

	
 
	
(A)
	
FMI’s delivery to DIAN in full compliance with the terms and conditions of the Laboratory Services Agreement of (i) the Initial FMI Information Technology deliverables and the FMI Technology Deliverables for the FoundationOne Product (in each case, as defined in the Laboratory Services Agreement), (ii) the FMI Technology Deliverables for the FoundationOne Heme Product (as defined in the Laboratory Services Agreement), and (iii) the FMI Technology Deliverables for the FoundationACT Product will, in each case of 3.3(A)(i)-(iii), satisfy FMI’s obligations to conduct or have conducted genomic sequencing locally for each applicable First Year Product in [...***...] pursuant to Section 7.4.2.3 of the Ex-US Commercialization Agreement;

 

	
 
	
(B)
	
During the term of the Collaboration (the “Collaboration Term”), FMI has satisfied its remaining obligations applicable to the China Territory under Section 7.4.2.3 of the Ex-US Commercialization Agreement (other than the obligations specified in clause 3.3(A) above, which are subject to the terms set forth therein); and

 

	
 
	
(C)
	
During the Collaboration Term, FMI’s obligations with respect to preparing, submitting and obtaining any Regulatory Approvals required to market, import, have imported, sell and have sold the First Year Products in the China Territory pursuant to Section 6.1.1 

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(Responsibility for Products Other than F1CDx) of the Ex-US Commercialization Agreement shall be satisfied.

 

3.4.Gross Margin Calculation for the China Territory.  Notwithstanding anything to the contrary in the Ex-US Commercialization Agreement, the Gross Margin on Sales of First Year Products in the China Territory (collectively, “China Sales”) for the purpose of calculating the royalty payments payable to FMI pursuant to Section 8.3 of the Ex-US Commercialization Agreement for each Calendar Quarter during the Collaboration Term shall be determined as follows:

 

	
 
	
(A)
	
The aggregate Gross Margin on Sales of the FoundationOne Product in the China Territory (the “China F1 GM”) shall be calculated as the greater of: (a) [...***...] and (b) [...***...] (the “China Minimum F1 GM”);

 

	
 
	
(B)
	
The aggregate Gross Margin on Sales of FoundationOne Heme  in the China Territory (the “China F1H GM”) shall be calculated as the greater of: (a) [...***...], and (b) [...***...] (the “China Minimum F1H GM”);

 

	
 
	
(C)
	
The aggregate Gross Margin on Sales of FACT in the China Territory (the “China FACT GM”) shall be calculated as the greater of: (a) [...***...], and (b) [...***...] (the “China Minimum FACT GM”); and

 

	
 
	
(D)
	
Finally, the aggregate Gross Margin on all China Sales (“China GM”) during such Calendar Quarter (which shall be the basis of the calculation of the royalty payment to FMI for Sales in the China Territory during such Calendar Quarter) shall be calculated as the sum of the China F1 GM, the China F1H GM, and the China FACT GM for such Calendar Quarter.

 

For clarity, “Clinical Reports,” as used in this Section 3.4, shall exclude Non-Commercial Clinical Reports. 

 

3.5.Royalties for the China Territory.  

 

(A)Royalty Enhancement.  With respect to China Sales only, the royalty tiers applicable to such China Sales shall be adjusted as follows: (a) a [...***...]% incremental increase will apply to the relevant royalty rate set forth in the Ex-US Commercialization Agreement for each of the [...***...]% and [...***...]% royalty tiers, and (b) a [...***...]% incremental increase will apply to the relevant royalty rate for each of the [...***...]% and [...***...]% royalty tiers.  Accordingly, the royalty rates applicable to China Sales will be as follows:

 

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Tier of Calendar Year Gross Margin (on an Aggregated Basis, for Sales in the Territory 
	
Percent (%) of Gross Margin of China Sales for Calculation of Royalty on China Sales

	
Up to and including US$[...***...]
	
[...***...]

	
Greater than US$[...***...] and up to and including US$[...***...]
	
[...***...]

	
Greater than US$[...***...] and up to and including US$[...***...]
	
[...***...]

	
Greater than US$[...***...]
	
[...***...]

 

For example, if Gross Margin on all Sales in the Territory (the “Global GM”) during the first Calendar Quarter of a given Calendar Year was US$[...***...] and Gross Margin on China Sales was US$[...***...], then the payment for the first Calendar Quarter based on Sales in the China Territory would be calculated as follows:

[...***...].

If the Global GM during the second Calendar Quarter of the same Calendar Year was US$20 million, and Gross Margin on China Sales was US$1 million, then the payment for the second Calendar Quarter based on China Sales would be calculated as follows:

[...***...].

 

(B)Royalty Tier Adjustment for Non-Commercial Clinical Reports. Additionally, notwithstanding anything to the contrary in the Ex-US Commercialization Agreement, the Non-Commercial Report GM Adjustment (as defined below) shall be added to the Global GM for the determination of royalty rate based on the “Tier of Calendar Year Gross Margin” under Section 8.3.2 of the Ex-US Commercialization Agreement. For clarity, the royalty rate applicable to the Global GM shall be determined based on the sum of (X) the Non-Commercial Report GM Adjustment, (Y) the China GM (as calculated in accordance with Section 3.4 (Gross Margin Calculation for the China Territory), and (Z) the Global GM exclusive of China GM. Nevertheless, the Non-Commercial Report GM Adjustment shall be excluded from Global GM in royalty calculation, i.e. Roche shall have no obligation under the Ex-US Commercialization Agreement and China Territory Agreement to pay to FMI royalties associated with the Non-Commercial Report GM Adjustment. 

 

“Non-Commercial Report GM Adjustment” shall mean the sum of (i) [...***...], (ii) [...***...], and (iii) [...***...].

 

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4.Integral Part of the Ex-US Commercialization Agreement.  Section 19 (Miscellaneous) of the Ex-US Commercialization Agreement is herein incorporated by reference.  Except as otherwise expressly modified hereby, all of the terms and conditions in the Ex-US Commercialization Agreement remain in force and effect.

 

 

[Signature page follows.]

 

 

 

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the Effective Date. 

		
	
Foundation Medicine, Inc.

 

/s/ Troy M. Cox

____________________________________

Name: Troy M. Cox

Title: President & CEO

Date: April 26, 2018
	
 

 

 

 

 

 

 

 

 

		
	
F. Hoffmann-La Roche Ltd

 

 

/s/ Stefan Arnold

____________________________________

Name: Stefan Arnold

Title: Head Legal Pharma

Date: April 26, 2018
	
 

 

 

 

/s/ Dr. Urs Schleuniger

____________________________________

Name: Dr. Urs. Schleuniger

Title: Head Chugai and Basel Alliance & Asset Management 

 

 

 

 

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