As filed with the Securities and Exchange Commission on August 2, 2013.
Registration No. 333-190226
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1
to
FORM S-1
REGISTRATION STATEMENT
Under
The Securities Act of 1933
FOUNDATION MEDICINE, INC.
(Exact name of registrant as specified in its charter)
Delaware | 8071 | 27-1316416 | ||
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification Number) |
One Kendall Square, Suite B3501
Cambridge MA, 02139
(617) 418-2200
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
Michael J. Pellini, M.D.
President and Chief Executive Officer
One Kendall Square, Suite B3501
Cambridge, MA 02139
(617) 418-2200
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Kingsley A. Taft, Esq. Arthur R. McGivern, Esq. Goodwin Procter LLP Exchange Place 53 State Street Boston, MA 02109 (617) 570-1000 |
Robert W. Hesslein, Esq. Senior Vice President and General Counsel Foundation Medicine, Inc. One Kendall Square, Suite B3501 Cambridge, MA 02139 (617) 418-2200 |
Patrick OBrien, Esq. Ropes & Gray LLP Prudential Tower 800 Boylston Street Boston, Massachusetts 02199-3600 (617) 951-7000 |
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement .
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box. ¨
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ¨ | Accelerated filer | ¨ | |||
Non-accelerated filer | (Do not check if a smaller reporting company) x | Smaller reporting company | ¨ |
CALCULATION OF REGISTRATION FEE
|
||||
Title of Each Class of Securities to be Registered |
Proposed Maximum
Aggregate
|
Amount of Registration Fee(3) |
||
Common Stock, par value $0.0001 per share |
$86,250,000 | $11,765 | ||
|
||||
|
(1) | Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act. |
(2) | Includes the offering price of additional shares that the underwriters have the option to purchase. |
(3) | Previously paid. |
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
Explanatory Note
Foundation Medicine, Inc. has prepared this Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-190226) solely for the purpose of filing Exhibits 10.13 and 10.14 to the Registration Statement and updating Item 16 of the Registration Statement and the Exhibit Index accordingly. This Amendment No. 1 does not modify any provision of the prospectus that forms a part of the Registration Statement and accordingly such prospectus has not been included herein.
PART II
Information Not Required in Prospectus
Item 13. Other Expenses of Issuance and Distribution.
The following table sets forth the fees and expenses, other than underwriting discounts and commissions, payable in connection with the registration of the common stock hereunder. All amounts are estimates except the SEC registration fee.
SEC registration fee |
$ | 11,765 | ||
FINRA filing fee |
* | |||
NASDAQ listing fee |
* | |||
Blue Sky fees and expenses |
* | |||
Printing and engraving expenses |
* | |||
Legal fees and expenses |
* | |||
Accounting fees and expenses |
* | |||
Transfer agent and registrar fees and expenses |
* | |||
Miscellaneous |
* | |||
|
|
|||
Total |
$ | |||
|
|
* | To be provided by amendment. |
Item 14. Indemnification of Directors and Officers.
Section 145 of the Delaware General Corporation Law, or the DGCL, authorizes a corporation to indemnify its directors and officers against liabilities arising out of actions, suits and proceedings to which they are made or threatened to be made a party by reason of the fact that they have served or are currently serving as a director or officer to a corporation. The indemnity may cover expenses (including attorneys fees) judgments, fines and amounts paid in settlement actually and reasonably incurred by the director or officer in connection with any such action, suit or proceeding. Section 145 permits corporations to pay expenses (including attorneys fees) incurred by directors and officers in advance of the final disposition of such action, suit or proceeding. In addition, Section 145 provides that a corporation has the power to purchase and maintain insurance on behalf of its directors and officers against any liability asserted against them and incurred by them in their capacity as a director or officer, or arising out of their status as such, whether or not the corporation would have the power to indemnify the director or officer against such liability under Section 145.
We have adopted provisions in our certificate of incorporation and bylaws to be in effect at the completion of this offering that limit or eliminate the personal liability of our directors to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended. Consequently, a director will not be personally liable to us or our stockholders for monetary damages or breach of fiduciary duty as a director, except for liability for:
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any breach of the directors duty of loyalty to us or our stockholders; |
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any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
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any unlawful payments related to dividends or unlawful stock purchases, redemptions or other distributions; or |
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any transaction from which the director derived an improper personal benefit. |
These limitations of liability do not alter director liability under the federal securities laws and do not affect the availability of equitable remedies such as an injunction or rescission.
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In addition, our bylaws provide that:
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we will indemnify our directors, officers and, in the discretion of our board of directors, certain employees to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended; and |
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we will advance reasonable expenses, including attorneys fees, to our directors and, in the discretion of our board of directors, to our officers and certain employees, in connection with legal proceedings relating to their service for or on behalf of us, subject to limited exceptions. |
We have entered into indemnification agreements with each of our directors and intend to enter into such agreements with certain of our executive officers. These agreements provide that we will indemnify each of our directors, certain of our executive officers and, at times, their affiliates to the fullest extent permitted by Delaware law. We will advance expenses, including attorneys fees (but excluding judgments, fines and settlement amounts), to each indemnified director, executive officer or affiliate in connection with any proceeding in which indemnification is available and we will indemnify our directors and officers for any action or proceeding arising out of that persons services as a director or officer brought on behalf of us and/or in furtherance of our rights. Additionally, each of our directors may have certain rights to indemnification, advancement of expenses and/or insurance provided by their affiliates, which indemnification relates to and might apply to the same proceedings arising out of such directors services as a director referenced herein. Nonetheless, we have agreed in the indemnification agreements that our obligations to those same directors are primary and any obligation of the affiliates of those directors to advance expenses or to provide indemnification for the expenses or liabilities incurred by those directors are secondary.
We also maintain general liability insurance which covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as directors or officers, including liabilities under the Securities Act.
The underwriting agreement filed as Exhibit 1.1 to this registration statement provides for indemnification of us and our directors and officers by the underwriters against certain liabilities under the Securities Act and the Exchange Act.
Item 15. Recent Sales of Unregistered Securities.
The following list sets forth information as to all securities we have sold since January 1, 2010, which were not registered under the Securities Act.
1. | On September 10, 2012, we issued an aggregate of 18,805,304 shares of our Series B preferred stock to 19 investors for aggregate consideration of approximately $42.5 million. On December 28, 2012, we issued an aggregate of 5,956,830 shares of our Series B preferred stock to five investors for aggregate consideration of approximately $13.5 million. |
2. | On November 1, 2010, we issued a Preferred Stock Purchase Warrant to Lighthouse Capital Partners VI, L.P., exercisable for an aggregate of up to 200,000 shares of our Series A preferred stock. |
3. |
On March 30, 2010, we issued an aggregate of 7,000,000 shares of our Series A preferred stock to one investor for aggregate consideration of approximately $7.0 million. On February 7, 2011, we issued an aggregate of 1,000,000 shares of our Series A preferred stock to one existing investor for aggregate consideration of approximately $1.0 million. On March 30, 2011, we issued an aggregate of 5,000,000 shares of our Series A preferred stock to one existing investor for aggregate consideration of approximately $5.0 million. On October 14, 2011, we issued an aggregate of 5,500,000 shares of our Series A preferred stock to one existing investor for aggregate consideration of approximately $5.5 million. On August 8, 2011, we issued an aggregate of 10,000,000 shares of our Series A preferred |
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stock to one investor for aggregate consideration of approximately $10.0 million. On August 23, 2011, we issued an aggregate of 5,000,000 shares of our Series A preferred stock to one investor for aggregate consideration of approximately $5.0 million. On April 18, 2012, we issued an aggregate of 10,250,000 shares of our Series A preferred stock to four existing investors for aggregate consideration of approximately $10.3 million. |
4. | Between August 5, 2010 and May 31, 2013, we have granted stock options to purchase an aggregate of 14,841,129 shares of our common stock with exercise prices ranging from $0.02 to $1.78 per share to our employees, consultants and directors pursuant to our 2010 Plan. Of these, options covering an aggregate of 350,656 shares were cancelled without being exercised. |
5. | We sold an aggregate of 5,764,657 shares of common stock to employees, directors and consultants for cash consideration in the aggregate amount of $187,018.14 upon the exercise of stock options. |
We deemed the offers, sales and issuances of the securities described in paragraphs (1) through (3) above to be exempt from registration under the Securities Act, in reliance on Section 4(2) of the Securities Act, including Regulation D and Rule 506 promulgated thereunder, regarding transactions by an issuer not involving a public offering. All purchasers of securities in transactions exempt from registration pursuant to Regulation D represented to us that they were accredited investors and were acquiring the shares for investment purposes only and not with a view to, or for sale in connection with, any distribution thereof and that they could bear the risks of the investment and could hold the securities for an indefinite period of time. The purchasers received written disclosures that the securities had not been registered under the Securities Act and that any resale must be made pursuant to a registration statement or an available exemption from such registration.
We deemed the grants of stock options described in paragraph (4) and the issuances of shares of common stock upon the exercise of stock options described in paragraph (5) as exempt pursuant to Section 4(2) of the Securities Act or to be exempt from registration under the Securities Act in reliance on Rule 701 of the Securities Act as offers and sales of securities under compensatory benefit plans and contracts relating to compensation in compliance with Rule 701. Each of the recipients of securities in any transaction exempt from registration either received or had adequate access, through employment, business or other relationships, to information about us.
All certificates representing the securities issued in the transactions described in this Item 15 included appropriate legends setting forth that the securities had not been offered or sold pursuant to a registration statement and describing the applicable restrictions on transfer of the securities. There were no underwriters employed in connection with any of the transactions set forth in this Item 15.
Item 16. Exhibits and Financial Statement Schedules.
(a) Exhibits:
The exhibits to the registration statement are listed in the Exhibit Index to this registration statement and are incorporated herein by reference.
(b) Financial Statements Schedules:
Schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.
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Item 17. Undertakings.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, or the Act, may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is therefore unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
The Registrant hereby undertakes that:
(a) | The Registrant will provide to the underwriter at the closing as specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser. |
(b) | For purposes of determining any liability under the Securities Act of 1933, as amended, the information omitted from a form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in the form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act of 1933, as amended, shall be deemed to be part of this registration statement as of the time it was declared effective. |
(c) | For the purpose of determining any liability under the Securities Act of 1933, as amended, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Cambridge, Commonwealth of Massachusetts, on August 2, 2013.
FOUNDATION MEDICINE, INC. | ||
By: |
/s/ Steven J. Kafka, Ph.D. |
|
Steven J. Kafka, Ph.D. | ||
Chief Operating Officer |
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement and Power of Attorney has been signed by the following person in the capacities and on the date indicated.
Name |
Title |
Date |
||
* Michael J. Pellini, M.D. |
President, Chief Executive Officer and Director (Principal Executive Officer) | August 2, 2013 | ||
* Jason Ryan |
Vice President, Finance (Principal Financial and Accounting Officer) | August 2, 2013 | ||
* Alexis Borisy |
Director | August 2, 2013 | ||
* Brook Byers |
Director | August 2, 2013 | ||
* Evan Jones |
Director | August 2, 2013 |
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Name |
Title |
Date |
||
* Mark Levin |
Director | August 2, 2013 | ||
* David Schenkein, M.D. |
Director | August 2, 2013 | ||
* Krishna Yeshwant, M.D. |
Director | August 2, 2013 |
* Pursuant to Power of Attorney
By: |
/s/ Steven J. Kafka, Ph.D. |
|
Steven J. Kafka, Ph.D. Attorney-in-Fact |
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EXHIBIT INDEX
Exhibit
No. |
Exhibit Index |
|
1.1* | Form of Underwriting Agreement | |
3.1** | Fifth Amended and Restated Certificate of Incorporation of the Registrant, as amended and currently in effect | |
3.2* | Form of Sixth Amended and Restated Certificate of Incorporation of the Registrant (to be effective upon completion of this offering) | |
3.3** | Bylaws of the Registrant, as amended and currently in effect | |
3.4* | Form of Amended and Restated Bylaws of the Registrant (to be effective upon completion of this offering) | |
4.1* | Form of Common Stock certificate of the Registrant | |
4.2** | Warrant to Purchase Preferred Stock of the Registrant, dated as of November 1, 2010, issued to Lighthouse Capital Partners VI, L.P. | |
4.3** | Second Amended and Restated Investors Rights Agreement, by and between the Registrant and the Investors named therein, dated as of June 20, 2013. | |
5.1* | Opinion of Goodwin Procter LLP | |
10.1** | Amended and Restated 2010 Stock Incentive Plan and forms of agreements thereunder | |
10.2* | 2013 Stock Option and Incentive Plan and forms of agreements thereunder | |
10.3* | Executive Employee Offer Letter issued by the Registrant to Michael J. Pellini, dated as of March 14, 2011. | |
10.4** | Executive Employee Offer Letter issued by the Registrant to Kevin Krenitsky, dated as of March 7, 2013. | |
10.5** | Executive Employee Offer Letter issued by the Registrant to Robert W. Hesslein, dated as of March 7, 2013. | |
10.6** | Executive Employee Offer Letter issued by the Registrant to Jason Ryan, dated as of March 7, 2013. | |
10.7* | Executive Employee Offer Letter issued by the Registrant to Steven J. Kafka, dated as of March 7, 2013. | |
10.8* | Form of Indemnification Agreement, to be entered into between the Registrant and its directors and officers | |
10.9** | Lease Agreement, by and between the Registrant and RB Kendall Fee, LLC, dated as of July 13, 2010. | |
10.10** | Lease, by and between the Registrant and 150 Second Street, LLC, dated as of February 4, 2013. | |
10.11** | Lease, by and between the Registrant and 150 Second Street, LLC, dated as of March 27, 2013. | |
10.12** | Loan and Security Agreement, by and between the Registrant and Lighthouse Capital Partners VI, L.P., dated as of November 1, 2010, as amended. | |
10.13# | Supply and Support Agreement, by and between the Registrant and Illumina, Inc., effective as of July 25, 2013. | |
10.14# | Laboratory Master Services Agreement, by and between the Registrant and Novartis Pharmaceuticals Corporation, dated as of November 21, 2011, as amended. | |
21.1** | Subsidiaries of the Registrant | |
23.1** | Consent of Ernst & Young LLP | |
23.2* | Consent of Goodwin Procter LLP (included in Exhibit 5.1) | |
24.1** | Power of Attorney (included in page II-5) |
* | To be included by amendment |
** | Previously filed |
| Indicates a management contract or any compensatory plan, contract or arrangement. |
# | Application has been made to the Securities and Exchange Commission for confidential treatment of certain provisions. Omitted material for which confidential treatment has been requested has been filed separately with the Securities and Exchange Commission. |
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Exhibit 10.13
***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
SUPPLY, SERVICE, AND SUPPORT AGREEMENT
This Supply, Service, and Support Agreement (the Agreement ) is effective as of the date of last signature found below (the Effective 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. , having a place of business at One Kendall Square, Suite B3501, Cambridge, MA, 02139 ( Customer ). 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.
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 NIPT, for specific diagnostic methods, for specific forensic methods, or for specific nucleic acid biomarkers, sequences, or combinations of biomarkers or sequences 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 NIPT, for specific diagnostic methods, for specific forensic methods, or for specific nucleic acid biomarkers, sequences, or combinations of biomarkers or sequences are examples of Application Specific IP.
Base Price means, with respect to (x) any [ *** ], (i) for [ *** ] of the Term, Illuminas [ *** ] for such [ *** ] in effect as of the Effective Date, and (ii) for [ *** ] of the Term thereafter, the lesser of (A) [ *** ], and (B) [ *** ], and (y) any [ *** ], Illuminas [ *** ]. For the avoidance of doubt, Illuminas [ *** ].
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 are designated with the pre-fix TG in their part number, which prefix indicates that they have the attributes detailed in Sections 10-12. Non-TG Consumables are all Consumables other than TG Consumables. All references in this Agreement to Consumables means both TG Consumables and Non-TG Consumables unless specified otherwise in this Agreement.
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 NIPT.
Customer Use means use in the Field, specifically excluding any use that (i) is not in accordance with the Products 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.
Country or Countries means the United States of America including its territories and possessions.
***Confidential Treatment Requested***
Documentation means Illuminas 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 [ *** ].
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.
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.
Third Party IP means the Intellectual Property Rights of third parties wherein third parties for purposes of this definition specifically exclude Affiliates of Illumina.
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 Products 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, [ *** ] 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 Appendix I. Service Contracts are subject to their separate conditions, limitations, and terms and conditions that are hereby incorporated herein by reference.
***Confidential Treatment Requested***
ILLUMINA CONFIDENTIAL
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Software means Illumina-Branded software (e.g., Hardware operating software, data analysis software), regardless of whether it is embedded in or installed on Illumina Hardware or provided separately.
Specifications means Illuminas 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 Customer intends to use for Customer Use and for which a TG version of such Consumable is not available from Illumina. Temporary Consumables are set forth in Exhibit A, as may be amended from time to time by the Parties; provided, however, that Non-TG Consumables purchased by Customer (i) after the Effective Date for Customer Use, but prior to the date Illumina can supply the first TG Consumable under this Agreement are deemed to fall within the definition of Temporary Consumable, and (ii) that Illumina agrees in writing may be used for Customer Use as a result of Illuminas inability to supply TG Consumables, such written authorization not to be unreasonably withheld, are deemed to fall within the definition of Temporary Consumable.
Term or term of this Agreement means the term of the Agreement as defined in Section 19.a.
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 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 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 during the Term a TG version of a Temporary Consumable ( TG Version ), Customer must, within [ *** ] months after the commercial 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 Review s. 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. |
***Confidential Treatment Requested***
ILLUMINA CONFIDENTIAL
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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 [ *** ]. The minimum quantity of TG Consumables 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, and (ii) $[ *** ]. (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 revert to the Base Price, regardless Customers volume of purchases. (y) In addition, if Customer does not meet its minimum purchase obligation (A) at any time prior to the third anniversary of the Effective Date, the Term of this Agreement (Section 19.a) shall automatically convert to [ *** ] years, and (B) at any time after the third anniversary of this Agreement, Illumina may in its sole discretion terminate this Agreement early by providing [ *** ] days prior written notice. |
3. Rights Accompanying Purchase .
a. | Consumables . Subject to the terms and conditions of this Agreement (including without limitation the restrictions in Section 5), Customers 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), Customers purchase of Illumina Hardware and Software 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 Hardware for a prohibited use. 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 Customers 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 Customers 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 Softwares 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. |
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e. | [ *** ]. Within [ *** ] of the Effective Date, the Parties shall negotiate and execute a [ *** ]. Subject to the terms and conditions of this Agreement, Customer and Illumina agree to comply with the terms of the [ *** ] during the Term (as defined herein). The Parties agree that the terms and conditions of the [ *** ] 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 owns or uses. 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, [ *** ]: |
i. | [ *** ]. Illumina will, [ *** ] for the Illumina Hardware used at [ *** ]. Such spare parts to be kept in stock shall include [ *** ] for [ *** ] HiSeq and other Illumina Hardware and Software. [ *** ] Customer and Illumina agree [ *** ] the terms and conditions of [ *** ] will solely govern all matters pertaining to such [ *** ]. |
ii. | [ *** ]. |
iii. | Qualification Services . Installation Qualification, Operational Qualification and Instrument Performance Verification are available upon the Customers request at any time during the term of the Agreement. The Base Price for such services, as of the Effective Date, are set forth in Exhibit A-1. The descriptions of these services are listed below: |
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Installation Qualification: documentation that facilities in which the instrument has been installed are in accordance with requirements and safety regulations of the original manufacturer. |
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Operational Qualification: evaluates the correct functionality of the equipment under test by examining and quantifying the specifications after installation. |
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Instrument Performance Verification: ensures the accuracy of the instrument after a major service event or replacement of specific modules. |
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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 . (a) Customers 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 Customers intended use of Product will not infringe Application Specific IP, Affiliate Application Specific IP, or Third Party IP. |
(b) 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 Illuminas 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 Illuminas 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. .
(c) 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.
(d) Customers breach of any term or condition of this Section 4(a) is a breach of the Agreement.
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5. Limitations on Use.
a. | Limitations on Use . |
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), (4) to use the TG Consumables and Temporary Consumables only for Customer Use and Research Use, (5) to use the Non-TG Consumables only for Research Use, (6) to use Hardware and Software only for Customer Use when Hardware and Software is used with TG Consumables and Temporary Consumables, and (7) to only use Products in Customers 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 (including a Customer Affiliate). [ *** ]. |
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 (e.g., IllumiCode/Universal Sequences, Oligonucleotide Capture Sequences, adapter sequences, and such other proprietary sequences as Illumina may identify from time to time) 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 . Please refer to the example in Exhibit B when reading this Section.
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. The general form of the Forecast along with an example of how forecasting works and when Purchase Orders (defined below) are to be provided is found in Exhibit B . The first Forecast is attached to this Agreement as Attachment I . 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 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. |
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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 [ *** ]%. |
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 [ *** ]. |
d. | Temporary Consumables Forecast ( [ *** ] ) . Customer may, in its discretion, provide a forecast of its expected requirements for Temporary Consumables during [ *** ] of the Agreement. |
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 USD, (ii) all payments must be made in USD. |
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 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 Illuminas 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 Taking TG Consumable . Illumina reserves the right to invoice Customer for [ *** ]% of the purchase price of any TG Consumables that Customer has a binding commitment to purchase under this Agreement (whether under a Forecast or a Purchase Order), but that Customer has not provided a Purchase Order for, or for which Customer is attempting to cancel the order or delivery for. If there is no applicable Purchase Order, the purchase price shall be the purchase price that would have applied under this Agreement had Customer placed a Purchase Order for such Consumables. [ *** ] failure to purchase Consumables under a binding commitment under this Agreement (whether under Forecast or a Purchase Order). |
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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 Customers 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 Illuminas facilities located in (i) the same country as Customers Facility shall be the date that is [ *** ], and (ii) a different country than Customers 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 7e provides Customers [ *** ] in a timely manner under this Agreement. For the avoidance of doubt [ *** ]. Illumina shall provide Customer with [ *** ]. |
i. | [ *** ]. 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 [ *** ] shall be sent in writing to: customerservice@illumina.com. The [ *** ] must include the following: [ *** ]. |
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 Customers accounts payable department, or any other address designated by Customer in writing. All payments by Customer on such invoices are due within [ *** ] after the date of the invoice. 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. [ *** ] Upon such Illumina Hardware meeting such testing criteria, Customer shall sign a document indicating [ *** ] of such Illumina Hardware. Customers failure to sign such document when such Illumina Hardware meets [ *** ] shall be a material breach of this Agreement by Customer. Payments made by Customer on invoices for Illumina Hardware that are installed by Illumina are due the earlier of (i) [ *** ] or (ii) [ *** ] |
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. |
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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 Customers 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 Customers 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 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 Illuminas 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 Illuminas 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 Illuminas 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 TG Consumable may be phased out of production and no longer available and/or there may be a new, reconfigured, or repackaged version of a TG Consumable 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 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 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. |
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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 Customers intended use for Customer Use. |
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 Customers intended use of the Products. Accordingly, Customer agrees to (i) diligently investigate and identify which Regulatory Approvals apply to Customers 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 Customers use of the Products. |
c. | Quality Audits . Illumina agrees to allow Customer to audit Illuminas operations that pertain to TG Consumables, 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. Customer shall sign Illuminas confidentiality agreement, if requested by Illumina, prior to conducting such audit. |
14. Limitation of Liability.
[ *** ] TO THE EXTENT PERMITTED BY LAW, IN NO EVENT SHALL [ *** ] OR [ *** ] BE LIABLE TO THE [ *** ] 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, [ *** ] 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).
[ *** ] 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 PARTYS 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 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 CUSTOMERS INTENDED USES.
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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 Partys 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 Partys 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 Partys Confidential Information to be retained by the Recipient Partys 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 Partys or its Affiliates 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 Information if available, and allows the Disclosing Party to participate in the process undertaken to protect the confidentiality of the Disclosing Partys 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 Partys 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. |
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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, Illuminas 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 Customers obligations [ *** ], Illumina shall (i) defend, indemnify and hold harmless Customer, its Affiliates, 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, 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 Illuminas 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 Customers 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 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) Illuminas 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) Customers 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, its Affiliate, or a party to whom Customer or its Affiliate 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 partys Intellectual Property Rights, to the extent a Claim results from, relates to, or arises out of (i) Customers breach of any term or condition, including breach of a representation or warranty made hereunder or included in this Agreement, (ii) Customers use of the |
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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) Customers 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) Customers 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 Customers use of a defective Product purchased by Customer under this Agreement ( Personal Injuries ), specifically excluding any Personal Injuries (i) [ *** ] 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 Partys 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 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-partys name. Customers sole right to indemnification with respect to such third party goods or software shall be pursuant to the original manufacturers or licensors 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 Customers 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 Customers 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 the 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, including an Affiliate of Customer. All warranties for Products are Facility specific and do not transfer if the Product is moved to another Facility of Customer, unless Illumina conducts 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 |
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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 Illuminas standard manufacturing and quality control processes. Illumina makes no warranty that custom Consumables will work as intended by Customer or for Customers intended uses. |
b. | Warranty for 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 Customers 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 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 warranty for the Hardware unless the upgrade was conducted by Illumina at Illuminas facilities in which case the upgraded 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 partys good not provided by Illumina (unless its Documentation or Specifications expressly state such third partys good is for use with it). |
d. | Sole Remedy . In the event Product does not conform to warranty, Illumina will repair or replace the Product, the choice being in its discretion. The following states Customers sole remedy and Illuminas sole obligations under the foregoing warranties. |
i. | Consumables . Illumina will repair or replace the Consumable in its discretion. Repaired Consumables come with a warranty that is [ *** ] or the [ *** ], whichever is longer, and replaced Consumables come with the same warranty as a new Consumable. With respect to replaced TG Consumables, Illumina will use commercially reasonable efforts to provide replacement TG Consumables in Customers next scheduled shipment where single lot per shipment can be maintained. |
ii. | Hardware . Illumina will repair or replace the Hardware its discretion. 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 is [ *** ], whichever is later. If only a component is being repaired or replaced, the warranty period for such component is [ *** ], whichever is longer. |
e. | Procedure . In order to be eligible for repair or replacement under this warranty Customer must (i) promptly contact Illuminas 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 Illuminas instructions or, if agreed by Illumina, grant Illuminas 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-partys 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 5 years thereafter (the Term ) unless otherwise terminated early as provided hereunder. |
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b. | Cancellation of Orders . All Purchase Orders accepted by Illumina are non-cancelable by Customer and may not be modified without the prior written consent of Illumina. |
c. | 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 [ *** ] 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 [ *** ]. |
d. | 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 the 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 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 Partys 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. |
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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. | Customer Inventory of Spare Parts . If Customer and Illumina agree to house spare parts for Illumina Hardware at Customers Facility the terms and conditions of Appendix II shall govern such spare parts. In the event of any conflict between the terms and conditions of Appendix II and the terms and conditions of this Agreement, the terms and conditions of Appendix II shall supersede. |
c. | 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. |
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 Customers facility), and further agrees that it will use Products in accordance with the Product Documentation. Notwithstanding anything to the contrary in the 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 Illuminas 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 [ *** ], and (ii) Illumina may assign this Agreement to any Affiliate without Customers 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: |
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If to Illumina:
Illumina, Inc. 5200 Illumina Way San Diego, CA 92122 Attn: Sr. VP. Translational Consumer Genomics |
If to Customer Foundation Medicine Inc One Kendall Square, B3501 Cambridge MA 02139 Attn: Chief Business Officer |
|
With a copy to: | With a copy to: | |
Illumina, Inc. 5200 Illumina Way San Diego, CA 92122 Attn: General Counsel |
Foundation Medicine Inc One Kendall Square, B3501 Cambridge MA 02139 Attn: General Counsel |
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 Illuminas suppliers or subcontractors, transportation difficulties, shortage of energy, raw materials or equipment, or the other Partys 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, Customers 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, Illuminas 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 Illuminas 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 Customer or Customers 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 |
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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. |
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 4-6 th calendar months of the year, the 7-9 th 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. |
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their respective duly authorized representatives.
Customer: | Illumina: | |||||||
By: | /s/ Steven J. Kafka | By: | /s/ Nicholas Naclerio | |||||
Name: | Steven J. Kafka, Ph.D. | Name: | Nicholas Naclerio | |||||
Title: | Chief Operating Officer | Title: | SVP Corporate & Venture Development | |||||
Date: | 24 July 2013 | Date: | 7/25/2013 |
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Exhibit A
Products
Product Prices [ *** ].
All Product prices in the tables below are at the List Price in effect on the Effective Date. List prices [ *** ]. Discounts are calculated as set forth in Exhibit A-1.
Only those Products listed in this Exhibit, as may be amended from time-to-time in writing by the Parties, may be purchased under this Agreement.
Consumables
TG Consumables Parts and Prices
TG Part Number |
Description |
[...*** ] Price |
||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] |
Non-TG Consumables (solely for Research Uses) Parts and Prices
[ *** ] provided that, any purchases of Non-TG Consumables shall be subject to the terms and conditions of this Agreement.
Temporary Consumables
Part Number |
Description |
[...***...] Price |
||||
[...***...] |
[ *** ] | [ *** ] | ||||
[...***...] |
[ *** ] | [ *** ] |
* | Temporary Consumables [ *** ] pursuant to the terms and conditions of this Agreement. |
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Illumina Hardware
Part Number |
Description |
[ *** ] Price |
||||
[...***...] |
[ *** ] | [ *** ] | ||||
[...***...] |
[ *** ] | [ *** ] |
Service Contract Pricing
Part Number |
Description |
List Price |
||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] |
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Exhibit A-1
Product Discounts
Quotes
First Quote . As used herein, price refers to Net Price. Illumina will provide Customer a quotation referencing this Agreement and specifying the price for each Consumable (the First Quote ). The First Quote and pricing found therein expires at the end of the [ *** ] (e.g., [ *** ]) of the Agreement and sets forth the pricing that will be used on all Purchase Orders that are provided by Customer prior to the end of such period. The Purchase Orders placed against the First Quote must reference the First Quote and this Agreement to be valid. The pricing for the First Quote will be determined using the Consumable pricing formula set forth below. Subject to the terms and conditions of this Agreement, if Customer desires to purchase additional Consumables that are available for purchase under this Agreement Customer may request a quote for those additional Consumables and Illumina shall provide an updated First Quote to Customer.
[ *** ] Quotes for Consumables . As used herein, price refers to Net Price. No later than [ *** ] prior to the start of each [ *** ] (i.e., [ *** ]) of this Agreement (each a [ *** ]), Illumina will issue a quotation referencing this Agreement and [ *** ] (the [ *** ] Quote ). Each [ *** ] Quote and pricing found therein expires at the end of the [ *** ] that starts following the date the [ *** ] Quote is due and sets forth the pricing that will be used on all Purchase Orders that are provided by Customer prior to the end of such [ *** ]. The Purchase Orders placed against each [ *** ] Quote must reference the [ *** ] Quote and this Agreement to be valid. The pricing for [ *** ] Quotes will be determined using the Consumable pricing formula set forth below. Subject to the terms and conditions of this Agreement, if Customer desires to purchase additional Consumables that are available for purchase under this Agreement Customer may request a quote for those additional Consumables and Illumina shall provide an updated [ *** ] Quote to Customer.
Consumable Pricing Formula
Customers purchase price for Consumables will be [ *** ].
Discount Formula |
||
A* | The purchase price equals [ *** ]. | |
B | The purchase price equals [ *** ]. |
* | This discount formula will terminate and no longer be available as of [ *** ] |
Consumable Discount |
||
Consumable Spend |
[ *** ] Base Price |
|
[ *** ] | [ *** ] | |
[ *** ] | [ *** ] | |
[ *** ] | [ *** ] | |
[ *** ] | [ *** ] | |
[ *** ] | [ *** ] |
Illumina Hardware Discount
Customers [ *** ].
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Illumina Hardware and Service Contract Discount
Tier |
Hardware |
Qty. |
[ *** ] Base Price |
|||
[ *** ] |
[ *** ] | [ *** ] | [ *** ] | |||
[ *** ] |
[ *** ] | [ *** ] | [ *** ] | |||
[ *** ] |
[ *** ] | [ *** ] | [ *** ] | |||
[ *** ] |
[ *** ] | [ *** ] | [ *** ] | |||
[ *** ] |
[ *** ] | [ *** ] | [ *** ] | |||
[ *** ] |
[ *** ] | [ *** ] | [ *** ] |
Illumina Qualification Services Price Table
Instrument |
Single Certification per
Instrument (IQ, OQ or IPV) |
Bundled Certification per
Instrument (IQ/OQ only) |
||
[...***...] |
[ *** ] | [ *** ] | ||
[...***...] |
[ *** ] | [ *** ] | ||
[...***...] |
[ *** ] | [ *** ] |
Illumina Service Contract [ *** ].
Instrument Number |
Discount off [ *** ] Price |
|
[ *** ] |
[ *** ] | |
[ *** ] |
[ *** ] | |
[ *** ] |
[ *** ] | |
[ *** ] |
[ *** ] | |
[ *** ] |
[ *** ] | |
[ *** ] |
[ *** ] |
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Exhibit B
Form of Forecast
Example Only
[ *** ]
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Attachment 1
First Forecast
[ *** ]
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Appendix I
Service Contract
The following section outlines the components of [ *** ] Service levels. [ *** ] Contracts are for a period of 12 months and must be renewed prior to their expiration by placing a Purchase Order with Illumina. The [ *** ] Service level requires [ *** ], as well as the purchase of a Parts-Only contract per instrument.
1. | [ *** ] On-Site Service Levels. |
1.1. | Technical Support Coverage |
The technical support hours available to the Customer are outlined in the table below. As services or times change going forward, the customer will be notified.
Time (EST) | Method of Contact | Contact Information | Location of Support Group | |||
8 AM 10 AM | E-mail with call back | [ *** ] |
East Coast |
|||
10 AM 8 PM | Direct Phone | [ *** ] |
WestCoast |
Weekday holiday coverage is available via email and limited phone replies. Currently there is no [ *** ] Technical Support available over [ *** ]. Additional coverage options are [ *** ], and Illumina [ *** ] the Customer [ *** ] of any changes made in the future.
1.2. | Gold Level. The Gold Service level provides the Customer with full coverage on all service parts and labor as well [ *** ] average on-site response time from Technical Support dispatch, hardware and software critical and non-critical updates, applications support, access to online training modules, and discounts on optional advanced training programs; provided that, Illuminas technical support group is notified of the dispatch request prior to [ *** ]. The Gold Service Level also includes [ *** ]. |
1.3. | Platinum Level. This Platinum Service level provides the Customer with full coverage on all service parts and labor as well as 5 x 24 e-mail support and 5 x 18 telephone support (instrument, applications, and bioinformatics). This service level also includes one business day average on-site response time from Technical Support dispatch, hardware and software critical and non-critical updates, applications support, access to online training modules, and discounts on optional advanced training programs; provided that, Illuminas technical support group is notified of the dispatch request prior to [ *** ]. This Platinum Service contract includes [ *** ]. |
1.4 | Dedicated On-Site Service Level. Customer may upgrade its desired Service Level at any time during the Term to the Dedicated On-Site Service Level as described below upon providing written notice to Illumina, in which event Customer will be obligated to (i) pay Illumina [ *** ]. At Customers request prior to upgrading its Service Level to the Dedicated On-Site Service Level, Illumina will provide Customer with information regarding the quantity and cost of spare parts used by Customer historically to enable Customer to evaluate whether it desires to upgrade to the Dedicated On-Site Service Level. |
Dedicated On-Site Service Contract which supplies the Customer with a qualified dedicated Field Service Engineer that will be staffed at the Customer Facility on a full time basis. This level of support requires a Parts-Only contract agreement for each instrument placed under this level of support and a [ *** ]. After [ *** ] Customer may cancel the Dedicated On-Site Service and revert to Gold or Platinum Service with [ *** ] days prior written notice to Illumina. This Service Level includes hardware and software critical and non-critical updates, applications support, access to online training modules, and discounts on optional advanced training programs. The Dedicated On-Site Service Level also includes [ *** ] preventative maintenance services a year. The standard hours of the Dedicated On-Site Field Representative will be determined jointly by the Customer and Illumina at the start of the Dedicated On-Site Service.
1.5 | If Customer is a Gold Service Level customer, [ *** ]. Under these Service Terms Customer will receive a response from the appropriate Field Service Engineer, Customer Solutions representative or Technical Support staff (as applicable) within 4 hours of notification by Customer, provided that Customer provides such notification within the hours specified in Section 1.1. above. |
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1.6. | In the event of an instrument that has seen [ *** ] and continues to be [ *** ] after [ *** ] attempts, the decision to remedy the issue by replacing the instrument will be at the discretion of the Director of Service Business, Director of Field Service and Regional Manager of Field Service. |
1.7. | All service events will be logged and documented in Field Visit Reports that will be provided to the Customer by the Field Representative upon conclusion of each service event and will also be made available to Customer in electronic format. These reports will outline (i) the diagnostic testing performed on each instrument to determine the underlying issue (ii) all repairs done on the instrument and any parts replaced and (iii) all verification performed during the service to ensure sufficient repair and functionality of the instrument. . |
1.8. | The Customer will be notified of any new updates or major changes to instrumentation and a basic explanation of the changes will be provided upon request. If additional Customer on-site training is requested, the Customer is able to purchase FAS visits on an hourly basis. In addition, training services that are available to the Customer can be found at www.illumina.com under the Support > Training > Course Catalog link. Illumina will work closely to ensure these needs are met. |
1.9. | Site Installed Base Description |
Asset Name |
Asset Description | Installation Date | Service Level | Expiration Date | ||||
[ *** ] | [ *** ] | [ *** ] | [ *** ] | [ *** ] | ||||
[ *** ] | [ *** ] | [ *** ] | [ *** ] | [ *** ] | ||||
[ *** ] | [ *** ] | [ *** ] | [ *** ] | [ *** ] | ||||
[ *** ] | [ *** ] | [ *** ] | [ *** ] | [ *** ] | ||||
[ *** ] | [ *** ] | [ *** ] | [ *** ] | [ *** ] | ||||
[ *** ] | [ *** ] | [ *** ] | [ *** ] | [ *** ] | ||||
[ *** ] | [ *** ] | [ *** ] | [ *** ] | [ *** ] |
Illuminas 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 Sellers 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. Documentation means Sellers 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 Sellers 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 Purchasers 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 Sellers 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 Softwares 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 Purchasers requests for service within the time period specified in the Service Contract. All requests for service must be made through Sellers customer support organization ( Purchaser Solutions ). Please refer to Sellers website for |
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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 Purchasers 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 Purchasers site. Seller shall respond to Purchasers 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. Purchasers use of all Software, updates, 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 Purchasers 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 Sellers Purchaser Solutions personnel. Sellers 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 Purchasers 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 Purchasers 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 Sellers 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 Purchasers 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 Purchasers Site, exclusive of any taxes or duties, which are the sole responsibility of Purchaser. Loaner hardware or components shall be certified by Sellers 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 Sellers request. Purchasers use of loaner hardware or components shall be subject to Sellers 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 Purchasers inability to provide a sufficient time period for such services and down time, Seller |
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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 . |
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 Sellers 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 Purchasers network. |
e. | Representative: A representative of Purchaser will be present on-site at all times service is being performed by Sellers 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 Sellers 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 Sellers 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 Sellers site requirements found in the Documentation or Specifications. Any material deviation from Sellers 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 conditions of such vendors 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 vendors terms and conditions shall remain in full force and effect. |
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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 Purchasers 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 conducts the move of the Covered Hardware on Purchasers 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 expressly written authorization of an officer of Seller. |
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 Purchasers 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 Purchasers 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 Purchasers 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 Sellers suppliers or subcontractors, transportation difficulties, shortage of energy, raw materials or equipment, or Purchasers 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 HARDWARE OR SERVICE CONTRACT, THE USE OF THE COVERED HARDWARE, THE ITEMS AND SERVICES PROVIDED HEREUNDER, SELLERS 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, SELLERS 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
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SERVICES PROVIDED HEREUNDER, AND SELLERS 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. |
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Appendix II
Customer Inventory of Spare Parts
1. | Target Inventory . Illumina and Customer will mutually agree in writing upon the quantity of and type of Parts to be held by Customer at Customers Facility ( Target Inventory ). Illumina will ship Customer the Target Inventory [ *** ] of the Effective Date. |
2. | Shipping; Title and Risk of Loss . Customer is responsible for all costs associated with the shipping and transportation of Parts to the Facility. Title to the Parts remains with Illumina until the Parts are used in Equipment. Risk of loss for the Parts transfers to Customer upon delivery of the Parts to the Facility. |
3. | Incoming Inspection; Inventory . Customer will inspect the Parts for damage upon receipt and record the amount and type of Parts received, the date and time of receipt, and serial numbers (if applicable). Customer will provide Illumina with written notice of any damaged Parts within 5 business days of their receipt. All Parts not identified as damaged within such 5 business day time period shall be considered the consigned inventory (Inventory). Customer shall, unless otherwise specified by Illumina, send any damaged Parts back to Illumina at Illuminas expense [ *** ] of receipt by Customer. |
4. | Consignment Fee . Customer will pay Illumina an amount equal to [ *** ] for the Target Inventory once per calendar year as a consignment fee (Consignment Fee). The Consignment fee is non-refundable. Illumina will invoice Customer the Consignment Fee promptly after the Effective Date. |
5. | Authorized Personnel Only . Only Illumina authorized personnel (Service Personnel) may withdraw Parts from the Inventory and/or install such Parts on the Equipment. |
6. | Storage and Possession . Customer will use reasonable care and best industry practices to maintain and store the Parts at the Facility. Customer will store the Parts separate from other parts at the Facility so that Parts are only accessible to Service Personnel (preferably in a locker with a key). Illumina may take possession of any Parts at any time up to the point of installation of the Parts by providing reasonable notice to Customer. Customer will cooperate and provide reasonable assistance to Illumina to regain possession of the Parts. Customer will not cause or permit any liens or encumbrances to attach to the Parts or any other property of Illumina at the Facility. |
7. | [ *** ] Usage and Count . Customer will perform a count of all Parts in Inventory [ *** ] and provide Illumina a written reporting containing the Part numbers, quantities of Parts in Inventory, Part description, and Part serial number (if applicable) ([ *** ] Count). If the [ *** ] Count is below the Target Inventory, Illumina will replenish the Inventory and Illumina will issue an invoice to Customer for such usage unless such Part(s) is covered under a then-current and valid Illumina service contract that covers the full cost of such Part. In the event of discrepancies, Customer will be invoiced for Parts that are missing from Inventory and have not already been paid for by Customer already. |
8. | Final Inventory Reconciliation; Disposition . Illumina will conduct a final count of Inventory during the last [ *** ] of this Agreement (Final Inventory Count) Customer will either purchase from Illumina all Parts remaining in Inventory (or otherwise received by Customer and not yet paid for) as of the Inventory count date, return the unused Parts to Illumina, or renew this Agreement for a mutually agreed upon subsequent term. Illumina shall be responsible for packaging and shipping such Parts back to Illumina if the Parts are returned to Illumina pursuant to this Section. If any Parts returned to Illumina are used or damaged (not due to shipment back to Illumina) at the time of Illuminas receipt, Illumina will invoice the Customer for such Parts. |
9. | Payment . Customer will make full payment of all invoices within [ *** ] of the date of invoice. Any amounts not paid when due will accrue interest at the rate of [ *** ], or the maximum amount allowed by law, if lower. Customer shall pay for all costs (including reasonable attorneys fees) incurred by Illumina in connection with the collection of payments. All prices for Parts are the price in effect on the date of Illuminas invoice. |
10. | Audits . Customer will keep accurate books and records related to the Parts. Illumina has the right to audit, at Illuminas expense, such Customer books and records in connection with this Agreement and the Parts supplied hereunder. |
11. | Compliance with Laws . Each Party agrees to comply with all applicable laws, regulations, and guidelines in connection with the management of Inventory under this Agreement. Customer will provide Illumina reasonable access to the Facility to inspect the Parts upon prior written notice. |
12. | Representations and Warranties . Customer represents and warrants that (i) the Facility will be maintained in good condition, (ii) the Parts will only be used with Illumina Equipment and for no other purposes, and (iii) it will not install and will not allow a third party to install the Parts (other than Service Personnel) on Equipment, unless otherwise authorized in writing by Illumina, and (iv) it will not sell, lease, or otherwise transfer the Parts to a third party without Illuminas prior written consent. |
***Confidential Treatment Requested***
ILLUMINA CONFIDENTIAL
31
13. | No Reverse Engineering . Customer agrees that Customer shall not, nor will Customer use or permit any third party to, engage in any of the following activities without the express prior written permission of an officer of Illumina: (i) disassemble, reverse-engineer, reverse-compile, or reverse-assemble the Parts or the Equipment, (ii) separate, extract, or isolate components of the Parts or the Equipment or subject the Parts and/or Equipment or components thereof to any analysis not expressly authorized in writing by Illumina, or (iii) otherwise gain access to or determine the methods of operation of the Parts or the Equipment. |
14. | Proprietary Information . Customer agrees that the contents, design, materials, properties, formulation, methods and techniques of operation and manufacture of the Parts and Equipment are the proprietary and trade secret information of Illumina and may not be disclosed to any third party and may not be used in any manner except as expressly authorized in writing by an officer of Illumina. |
ILLUMINA CONFIDENTIAL
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Exhibit 10.14
***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
NOVARTIS PHARMACEUTICALS CORPORATION
Laboratory Master Services Agreement
FOUNDATION MEDICINE, INC.
One Kendall Square
Cambridge, MA 02139
LABORATORY MASTER SERVICES AGREEMENT
INDEX:
1. | General Scope of Agreement |
2. | Term of Agreement |
3. | Payment Terms |
4. | Ownership |
5. | The Samples |
6. | Confidential Information |
7. | Publicity |
8. | Indemnification |
9. | Insurance |
10. | Termination |
11. | Conformance with Law and Accepted Practice |
12. | Subcontractors |
13. | Applicable Law |
14. | Independent Contractor |
15. | Entire Agreement |
16. | Severability |
17. | Assignment |
18. | Waiver |
19. | Debarment Certification |
20. | Data Protection (Privacy) and Security |
21. | Responsibilities of Institution |
22. | Corporate Citizenship |
Attachment 1: Sample Task Order
Attachment 2: Affiliate Agreement
[ *** ]
***Confidential Treatment Requested
LABORATORY MASTER SERVICES AGREEMENT
This Master Agreement is entered into as of November 21, 2011 by and between Novartis Pharmaceuticals Corporation (Novartis), with an office at 59 Route 10, East Hanover, NJ 07936, and Foundation Medicine, Inc. (Institution), with an office at One Kendall Square, Suite B6501, Cambridge, MA 02139.
1. | G ENERAL S COPE O F A GREEMENT |
A. Institution hereby agrees to perform any and all services (the Services) set forth in any Task Order issued in the sample form attached hereto as Attachment 1, after the date hereof, to Institution by Novartis and accepted by Institution, with respect to the laboratory samples identified therein (the Samples). Institution shall provide all personnel and equipment necessary to perform the Services. Institution shall not perform any Services hereunder beyond the scope of the Task Order without the prior written approval of Novartis.
B. This Agreement shall apply to any Task Order and to any Services performed pursuant thereto. Each such Task Order issued by Novartis and accepted by Institution shall constitute a separate and distinct contract between the parties, it being understood and agreed, however, that the terms and conditions of this Agreement shall be deemed incorporated in each such Task Order and shall take precedence over any contrary or inconsistent terms and conditions appearing or referred to in any such Task Order, unless the Task Order explicitly states otherwise. No such contrary or inconsistent terms and conditions, nor any contrary, inconsistent or additional terms in any document issued by Institution shall become part of any such contract unless accepted in writing by both parties.
2. | T ERM O F A GREEMENT |
Unless sooner terminated pursuant to the terms of this Agreement, this Agreement shall be deemed effective from November 21, 2011 to November 30, 2014. Notwithstanding the foregoing, should any Task Orders entered into during the period of this Agreement require Services to be performed beyond the termination date of this Agreement, then the terms of this Agreement shall remain in effect with respect to such Task Orders until the termination of the Task Orders.
3. | P AYMENT T ERMS |
A. In consideration of the satisfactory performance of the Services, Novartis will pay Institution in accordance with each Task Order. Institution bears the sole responsibility for compensation (including overtime to hourly employees, if applicable) of Institutions employees. Unless Novartis reasonably objects to all or a portion of any invoice submitted to it by Institution, Novartis shall make payments against the invoice within sixty (60) days of its receipt.
B. Novartis shall be liable only for those taxes imposed on a purchaser of services by operation of law. Novartis may require Institution to provide Novartis with documentation satisfactory to Novartis establishing the liability for such taxes. Should any Task Order state that Novartis will reimburse Institution for out-of-pocket expenses incurred by Institution in performing this Agreement, then Novartis shall do so, provided that such expenses are necessary
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to the performance of the Services hereunder, that they are reasonable (not luxury or first class), and have been approved in writing and in advance by Novartis. All such expenses shall be billed to Novartis at actual cost, and, for expenses in excess of $25.00, must be supported by receipts or other appropriate documentation. All invoices shall clearly state the following: invoice number, purchase order number, purchase order line number, amount due, progress payment number and Final Bill (on the last invoice). At no time shall Institution pre-bill or bill-to-estimate. Should Institution anticipate that amounts to be billed may exceed amounts set forth on the applicable Task Order by 10% or by $20,000 (whichever is less), then Institution shall immediately so notify Novartis in writing.
C. All costs and rates set forth in each Task Order shall remain firm for the duration of the Services to be performed thereunder, unless otherwise agreed to in writing by the Institution and Novartis.
D. Institution represents and warrants that any rate charged by Institution to Novartis [ *** ] shall remain, equal to or less than Institutions established standard rates consistently applied and charged by Institution to its other similarly situated customers for the same items.
E. Institution will undertake commercially reasonable endeavors to negotiate the most favorable rates for all pass-through costs and all savings obtained will be passed onto Novartis.
F. Institution warrants that all pass-through costs invoiced to Novartis will be balance sheet neutral.
G. All invoices for Services must be received within ninety (90) days of the expiration or termination of the applicable Task Order. In no event shall Novartis be obligated to pay any invoice received by it more than six (6) months after the expiration or termination of the applicable Task Order.
4. | O WNERSHIP |
A. All materials, information, data and writings provided to the Institution by and/or on behalf of Novartis, in any form whatsoever, which was owned by or licensed to Novartis prior to being provided to Institution, shall remain the property of Novartis (the Novartis Property). Institution shall acquire no right, title or interest in the Novartis Property as a result of its performance of the Services.
B. All information, data, inventions, writings and other work products, in any form whatsoever, both tangible and intangible, which are not Component Improvements (as defined below) and result from the performance of the Services (collectively, the Works), shall be the sole and exclusive property of Novartis. Novartis may transfer or use the Works for any lawful purpose without any further payment to Institution. In the event Novartis decides to file one or more patent applications covering any such Works, Institution shall at Novartiss request and expense assist Novartis in the preparation and prosecution of such patent applications and shall execute all documents reasonably deemed necessary by Novartis for the filing thereof and/or the vesting in Novartis of all title thereto.
***Confidential Treatment Requested
2
C. Notwithstanding the foregoing, intellectual property owned by or licensed to Institution prior to its entry into this Agreement, and which is used by Institution in the performance of the Services (the Components) and any improvements or modifications to the Components that are developed by Institution in connection with the performance of the Services (Component Improvements) shall remain the property of Institution. Novartis agrees not to assert against Institution and its licensors or licensees any ownership interest in the Components or Component Improvements. Notwithstanding the foregoing, Novartis shall have a non-exclusive, irrevocable, perpetual, non-transferable (except to Affiliates and to other persons Novartis transfers or authorizes to use the Works), worldwide, royalty-free license to use such Components to the extent necessary to use the Works. As used herein, the term Affiliates shall mean corporations, partnerships or other business entities which, directly or indirectly, through one or more intermediaries, are controlled by, control, or are under common control with, Novartis or Institution, as applicable. As used herein, the term control (including the terms controlled by and under common control with) means the possession of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, or otherwise.
D. Novartis hereby grants to Institution [ *** ].
E. Upon the request of Novartis, after completion of the Services pursuant to any Task Order, or the termination of this Agreement, Institution shall return to Novartis all Novartis Property, and shall provide to Novartis all Works.
F. [ *** ].
G. Institution shall acquire no right, title or interest in any of the trademarks, service marks or copyrights belonging to Novartis by the performance of any Services for Novartis hereunder.
H. The obligations under this Article shall survive the termination of this Agreement.
5. | T HE S AMPLES |
A. Novartis represents, warrants and covenants to Institution as follows:
i. all Samples and related information provided to Institution pursuant to this Agreement were collected or will be collected, handled, and transferred in compliance with all applicable state, federal and foreign laws and regulations relating to protection of human research subjects, privacy and security of individually identifiable health information, and standards for notification of breaches of individually identifiable health information applicable and in effect at the time and location of the collection and transfer of such Samples or information and any applicable policies of any institutional review board, privacy board, or ethics committee with jurisdiction over the collection, handling, and transfer of such Samples or information.
ii. all Samples and related information provided to Institution pursuant to this Agreement shall be provided with all direct identifiers removed in accordance with 45 C.F.R. Section 164.514(e)(2). If any Services will entail the provision to Institution of any information that is not fully de-identified in accordance with 45 C.F.R. Section
***Confidential Treatment Requested
3
164.514(b), the corresponding Task Order shall include each of the elements of the mandatory Data Use Agreement as specified in 45 C.F.R. Section 164.514(e)(4)(ii)(A)-(C).
B. Institution shall not transfer any Samples or other materials obtained or received in connection with this Agreement, or any derivatives thereof, to any third party without Novartis prior written approval.
C. Institution shall use the Samples and materials obtained or received in connection with this Agreement solely for the performance of the Services in Institutions laboratories under suitable containment conditions in accordance with all applicable laws and regulations and may make Component Improvements incidental to performing the Services. Institution shall not analyze the samples or materials other than as necessary to perform the Services.
D. Upon completion of the Services under any Task Order, or upon termination of any Task Order, Institution shall return to Novartis or destroy, as requested by Novartis, any unused samples and materials obtained or received in connection with this Agreement.
E. Novartis intends to use the results of the Services for uses reasonably related to the development and submission of information under a U.S. federal law that regulates that manufacture, use, or sale of drugs. The foregoing does not in any way limit any other rights or uses of the results of the Services by Novartis.
6. | C ONFIDENTIAL I NFORMATION |
A. Each party agrees not to publish, disclose or use for any purpose other than such partys performance hereunder (including, for clarity, as may be required by the exercise by Institution of its rights in Correlation IP) any and all information disclosed to or developed by the other party in connection with this Agreement or with any Service performed hereunder (collectively Information). [ *** ]. This obligation of non-disclosure shall not apply to the following:
i. Information at or after such time that it is or becomes publicly available through no fault of the receiving party;
ii. Information that is already independently known to the receiving party as shown by prior written records, provided that the receiving party so advises the disclosing party promptly upon the discovery that the Information is already independently known to the receiving party;
iii. Information that is independently developed by the receiving party without use of the disclosing partys Information;
iv. Information at or after such time that it is disclosed to the receiving party by a third party with the legal right to do so; or
v. Information required to be disclosed pursuant to judicial process, court order or administrative request, provided that the receiving party shall so notify the other party sufficiently prior to disclosing such Information as to permit the other party to seek a protective order.
B. The parties obligations under Paragraph 6(A) shall survive and continue for a period of five (5) years after the termination of this Agreement.
***Confidential Treatment Requested
4
7. | P UBLICITY |
A. The Institution shall not disclose that Novartis has retained the Institution for professional Services without the prior written permission of Novartis, which permission shall not be unreasonably withheld.
B. No party shall use, or authorize others to use, the name, symbols, or marks of any other party hereto in any advertising or publicity material or make any form of representation or statement with regard to the Services which would constitute an express or implied endorsement by such other party of any commercial product or service without that other partys prior written approval.
8. | I NDEMNIFICATION |
A. Institution agrees to hold Novartis (including officers, directors, employees and agents of Novartis) harmless from and against any and all claims and suits brought by any third party, and any corresponding liabilities (collectively, the Claims), to the extent such Claims arise out of or are attributable to the wrongful act or omission, or to the negligence of Institution (including, but not limited to, Institutions employees, subcontractors or agents) during the course of its performance of the Services pursuant to this Agreement, [ *** ].
B. Novartis agrees to hold Institution (including the officers, directors, employees and agents of Institution) harmless from and against any and all Claims, to the extent such Claims arise out of or are attributable to the wrongful act or omission, or to the negligence of Novartis (including, but not limited to, Novartiss employees, subcontractors or agents) during the course of the performance of the Services pursuant to this Agreement.
C. The party responsible for holding the other party harmless shall have the right to select defense counsel and to direct the defense or settlement of any such Claim. The party being held harmless shall reasonably cooperate with the other party and its legal representatives in the investigation and defense of any Claim. The party being held harmless may obtain representation by separate legal counsel, at its own expense.
D. Each party undertakes to indemnify, defend and hold harmless the other party from and against any and all Claims to the extent resulting from a breach by such party of its obligations under this Agreement and to provide assistance to the other party in connection with any related civil, administrative or criminal proceedings against the other party.
E. The parties obligations under this Article shall survive and continue after the termination of this Agreement
***Confidential Treatment Requested
5
9. | I NSURANCE |
A. Novartis warrants that it maintains a policy or program of insurance or self-insurance at levels sufficient to support the indemnification obligations assumed herein. Upon request Novartis will provide evidence of its insurance.
B. Institution agrees that it shall maintain during the performance of this Agreement the following insurance or self-insurance in amounts no less than that specified for each type:
i. general liability insurance with combined limits of not less than $1,000,000 per occurrence and $1,000,000 per accident for bodily injury, including death, and property damage;
ii. workers compensation insurance in the amount required by the law of the state(s) in which the Institutions workers are located and employers liability insurance with limits of not less than $1,000,000 per occurrence; and
iii. in the event that the use of a motor vehicle is required in the performance of this Agreement, automobile liability insurance with combined limits of not less that $1,000,000 per occurrence and $1,000,000 per accident for bodily injury, including death, and property damage is required.
C. Institution will provide Novartis with evidence of Institutions insurance. Institution will name Novartis as an additional insured party under Institutions insurance policy, and will provide to Novartis at least thirty (30) days prior written notice of any change or cancellation to Institutions insurance program, or ten (10) days prior written notice of any impending cancellation for non-payment of premium.
10. | T ERMINATION |
A. This Agreement and any Task Orders issued hereunder may be terminated by Novartis for any reason or for no reason at all, upon thirty (30) days written notice to Institution. In the event that (a) either party becomes insolvent or is unable to pay its debts as they become due, or a petition in bankruptcy or for reorganization is filed by or against it that is not stayed or dismissed within sixty (60) days after filing, or a receiver is appointed of the whole or any substantial portion of its property; or (b) either party is in material breach of its obligations hereunder, which breach remains uncured for fifteen (15) business days following receipt of written notice from the other specifying the breach, then the other party shall have the right to immediately terminate this Agreement, without prejudice to its other rights or remedies, by written notice of such election.
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B. Except for termination due to material breach by the Institution, in which case Novartis shall owe Institution no further obligation, upon the effective date of termination (the Termination Date), Institution shall conduct an accounting, subject to verification and approval by Novartis. Within thirty (30) days after receipt by Novartis of reasonable documentation setting forth the results of such an accounting, Novartis will make payment to Institution for:
i. all Services properly rendered and moneys properly expended by the Institution until the Termination Date and not yet paid for; and
ii. reasonable non-cancelable obligations properly incurred for the Services by the Institution prior to receipt of notice of termination, unless Novartis reasonably objects to any charge, in which case the parties shall use best efforts to expeditiously resolve any disagreement.
C. Institution will return to Novartis within sixty (60) days of the Termination Date any funds advanced to it but not expended or irrevocably obligated by the Institution prior to the Termination Date.
11. | C ONFORMANCE W ITH L AW A ND A CCEPTED P RACTICE |
A. The Institution shall perform the Services (i) in a professional manner; (ii) in conformance with that level of care and skill ordinarily exercised by other professional institutions in similar circumstances; and (iii) in compliance with all applicable local, state and federal laws and regulations.
B. Each party warrants that it is presently, and shall remain, for the term of this Agreement and any extension thereof, free from any commitments that would create a conflict of interest impeding the completion of such partys obligations hereunder. As an independent contractor, Institution may perform consulting Services for third parties, outside of the time devoted to Novartis under this Agreement, except where there is a direct conflict of interest with the Services. Institution shall require any subcontractors or sub-subcontractors retained to assist Institution in the performance of the Services to agree to maintain itself free from conflicts of interest pursuant to terms substantially similar to those set forth in this Paragraph.
12. | S UBCONTRACTORS |
Institution shall not subcontract any of this Agreement without the prior written approval of Novartis. Any such approval shall not relieve Institution of its obligations under this Agreement. Institution may not make use of the Services of any subcontractor or sub-subcontractor if Novartis has disapproved of that subcontractor or subcontractor.
13. | A PPLICABLE L AW |
This Agreement shall be construed by and enforced in accordance with the laws of the State of New Jersey without regard to principles of conflicts of law and any lawsuit which may arise with respect to this Agreement shall be brought only in a court of competent jurisdiction located within the State of New Jersey.
14. | I NDEPENDENT C ONTRACTOR |
A. In the performances of all Services hereunder, the Institution shall be deemed to be and shall be an independent contractor and, as such, neither the Institution nor its employees shall be entitled to any benefits applicable to employees of Novartis.
B. Neither party is authorized or empowered to act as agent for the other for any purpose and shall not on behalf of the other enter into any contract, warranty or representation as to any matter. Neither party shall be bound by the acts or conduct of the other.
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15. | E NTIRE A GREEMENT |
This Agreement and any Task Orders issued hereunder represent the entire understanding of the parties with respect to the subject matter hereof and merge and supersede all prior and contemporaneous agreements or understandings oral or written with respect thereto. Neither this Agreement nor any Task Orders issued hereunder shall be modified except by a written agreement signed by the parties hereto specifying that it is a modification to the Agreement. For clarity, the Pilot Agreement shall survive execution of this Agreement in accordance with its terms.
16. | S EVERABILITY |
The invalidity or unenforceability of any term or provision of this Agreement shall not affect the validity or enforceability of any other term or provision hereof.
17. | A SSIGNMENT |
Neither party hereto may assign, delegate or transfer any of its rights or obligations under this Agreement without the written consent of the other party, which consent may not be unreasonably withheld; provided that, without such consent either party may assign this Agreement in connection with the transfer or sale of all or substantially all of its assets or business to which this Agreement relates or its merger or consolidation with another company. Either party may assign this Agreement in whole or in part to any of its corporate Affiliates without consent of the other party. Any Novartis Affiliate that desires to benefit from the terms of this Agreement and/or any Task Order hereunder shall enter into an Affiliate Agreement with the Institution substantially in the form of Attachment 2. Each such Affiliate Agreement shall be deemed to be a separate agreement between the Novartis Affiliate and the Institution, as the case may be, and not a part of this Agreement. No assignment shall relieve either party of the performance of any accrued obligation which such party may have under this Agreement.
Institution shall, during the course of this Agreement and for two (2) years after the termination or expiration of this Agreement or the applicable Task Order, whichever is later, keep and make available to Novartis or its public accountants or other representatives for inspection and audit at all reasonable times, time (including Institutions employee billing/time records) cost and expense records in connection with fees and expenses, including outside expenses incurred and services and materials procured by Institution under this Agreement, but excluding payroll records for Institution employees. Any such audits or inspections shall be conducted at Novartis expense; however, in the event an audit or inspection reveals an overcharge equal to in excess often percent (10%) of the total fees and expenses for the period of the audit, Institution shall bear the cost of the audit.
8
18. | W AIVER |
No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition, or of any other term, provision or condition of this Agreement.
19. | D EBARMENT C ERTIFICATION |
The Institution hereby represents and warrants that neither the Institution nor any person employed by the Institution in connection with any work to be performed for or on behalf of Novartis hereunder has been debarred under Section 306(a) or (b) of the Federal Food, Drug and Cosmetic Act, and that no debarred person will in the future be employed by the Institution in connection with any work to be performed for or on behalf of Novartis hereunder. If at any time after execution of this Agreement, the Institution becomes aware that the Institution or any person employed by the Institution in connection with any work to be performed for or on behalf of Novartis shall become or shall be in the process of being debarred, the Institution hereby agrees to so notify Novartis at once.
20. | D ATA P ROTECTION (P RIVACY ) A ND S ECURITY |
For the purposes of this Section of this Agreement, the following terms shall have the meanings given below:
Personal Data means any information that can be used to identify, locate or contact an individual (a Data Subject), including but not limited to (a) first name or initial and last name; (b) home or other physical address; (c) telephone number; (d) email address or online identifier associated with the individual; (e) social security number or other similar identifier; (f) employment financial or health information; or (g) any other information relating to an individual that is combined with any of the above.
Data Security Breach means (a) the loss or misuse (by any means) of Personal Data; (b) the inadvertent, unauthorized and/or unlawful processing, access, disclosure, alteration, corruption, transfer, sale or rental, destruction or use of Personal Data; or (c) any other act or omission that compromises the security, confidentiality, and/or integrity of Personal Data.
Study Data means all data related to any Data Subject collected by or transferred to your organization, its Affiliate or business partners, in connection with any services that you may provide to Novartis.
A. Institution shall collect and process Study Data in accordance with the provisions of this Agreement and in compliance with all applicable laws with respect to the processing of Study Data, including but not limited to applicable international, US federal, state and local data protection and data security laws.
B. To ensure the privacy and security of the health or medical data, including Study Data or other Personal Data related to this Agreement, the Institution shall create, acquire, receive, maintain, or transmit as a result of entering into the Agreement, Institution shall implement adequate and reasonable safeguards to prevent the use or disclosure of such information other than as provided for in the Agreement, and to protect the confidentiality, integrity, and availability of such information. In addition, Institution shall protect all such data, in accordance with applicable International Data Protection laws and US federal and state laws and regulations.
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C. Institution understands and agrees that the confidentiality, privacy and security requirements contained in this Agreement also apply to any permitted sub-contractors, temporary employees or other third-parties who receive any health or medical data, including Study Data, or other Personal Data, as a result of this Agreement. Institution will ensure that all of these parties enter substantially similar confidentiality, privacy and security agreements with Institution. Copies of such Agreements shall be provided to Novartis within seven (7) business days upon written request of Novartis.
D. Institution shall also ensure that its own employees, as well as any permitted subcontractors, temporary employees or other third-parties who assist the Institution in performing the Agreement, and who have access to any health or medical data, including Study Data or other Personal Data, as a result of this Agreement receive appropriate privacy and security training, which shall be updated periodically in accordance with applicable laws, regulations, and industry standards, or as otherwise reasonably requested by Novartis.
E. Institution, its Affiliates and agents shall not collect or process health or medical data, including Study Data or any other Personal Data related to this Agreement, in a manner that involves the transfer of such Personal Data from one jurisdiction to any other jurisdiction (the EEA constituting a single jurisdiction for this purpose), without the prior written consent of Novartis.
F. Institution understands that Novartis has certified to the US Department of Commerces Safe Harbor privacy program, which sets forth standards for accessing, processing, and sharing EU Personal Data. In that regard, for identifiable Personal Data pertaining to EU residents which Institution shall create, acquire or receive as a result of entering to this Agreement with Novartis, Institution agrees to comply with the Safe Harbor Standards pertaining to that information. Those standards are: (1) Notice; (2) Consent (Choice); (3) Onward Transfer [i.e., binding by written agreement any permitted third parties or subcontractors who may have access to any EU Personal Data under this agreement]; (4) Security; (5) Data integrity; (6) Individual Access Rights; and (7) Enforcement. More information about those requirements can be found by going to the Safe Harbor website at http://www.export.gov/safeharbor/sh_documents.html . Institution agrees that the Safe Harbor standards shall apply to EU Personal Data in addition to the other contract requirements in this Agreement.
G. Institution undertakes to comply with its obligations (if any) under applicable legislation to notify any supervisory authority of its collection and processing activities under this Agreement and further agrees to take all such steps as Novartis may reasonably require from time to time in order to enable Novartis to comply with any notification obligation applicable to Novartis.
H. Institution will ensure that it does not collect any health or medical data, including Study Data, relating to individuals other than the categories of data specified in the protocol identified in the applicable Task Order and will collect and process Study Data for the sole purpose of the study identified in the applicable Task Order and not further process such data in any other manner.
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I. Institution will not disclose health or medical data, including Study Data, or any other Personal Data related to this Agreement, to a third party outside of the requirements of this Agreement without the prior permission in writing of Novartis, except where such disclosure is required by any applicable law, regulation or supervisory authority, in which case the Institution will, wherever possible, notify Novartis prior to complying with any such request for disclosure and shall comply with all reasonable directions of Novartis with respect to such disclosure.
J. Institution will have appropriate procedures in place for the destruction or purging of any medical or health data, including Study Data and any other Personal Data, related to this Agreement when the retention time that applies to the data has been reached.
K. Institution shall ensure that it has appropriate procedures in place to fulfill applicable International Data Protection laws and US federal and state or other legal requirements, should an individual request access to or changes to the health or medical data, including Study Data or any Personal Data related to this Agreement, maintained by Institution. Institution will notify Novartis promptly (and in any event within five (5) days after receipt) of any communication received from a Data Subject relating to the Data Subjects rights to access, modify or correct Study Data and to comply with all instructions of Novartis in responding to such communications.
L. Institutions obligation to maintain privacy and security over medical or health data, including Study Data and other Personal Data received pursuant to this Agreement, will survive the termination or expiration of this Agreement.
M. At any time during the processing of Personal Data, the Institution shall notify Novartis immediately (but no later than three (3) days from the date) of any Data Security Breach involving Novartis data. Institution agrees to assist and cooperate with Novartis concerning any disclosures to affected parties, government or regulatory agencies and with any other remedial measures requested by Novartis or required under any applicable law.
21. | R ESPONSIBILITIES O F I NSTITUTION |
A. Institution shall have the responsibilities and shall perform the Services as specified in individual Task Orders. A Task Order may require Institution to co-ordinate with Novartis and/or other parties in performing the Services.
22. | A DHERENCE T O O VERALL S TANDARDS |
A. Institution shall perform the Services in accordance with all applicable laws and regulations including the FDA and EU Regulations, as well as generally accepted conventions such as the Declaration of Helsinki and their amendments and in accordance with the current Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) Regulations, as applicable. Institution warrants that it has all of the required authorizations to perform the Services under this Agreement.
11
B. Institution shall maintain its Standard Operating Procedures (SOPs) and internal procedures in compliance with these laws and regulations, shall ensure the SOPs and internal procedures that are in place are fully implemented and personnel have received documented training on such procedures. Upon Novartis request, Institution agrees to provide Novartis with a list of existing SOPs and on-site review of its SOPs and internal procedures.
C. Institution shall maintain applicable accreditation through a scheme run by a recognized body that is independent of Institution, such as CLIA (Clinical Laboratory Improvement Amendments), CAP (College of American Pathologies), CPA (Clinical Pathology Accreditation), NATA (National Association of Testing Authorities), or an equivalent. Each accreditation certificate must be gained via a process involving inspection of Institution by the accrediting authority at least every two (2) years. Upon request, Institution shall provide a copy of the relevant accreditation certificates to Novartis.
D. It is agreed that Novartis authorized representative(s), and regulatory authorities to the extent required by law and applicable to the scope of the Services being performed under any Task Order, may, during regular business hours, in accordance with arrangements made in advance with Institution (which shall include, without limitation, confidentiality arrangements reasonably satisfactory to Institution):
(1) | examine and inspect Institutions facilities required for performance of the Services including all computer and other systems for data management or programming; and |
(2) | inspect and copy all data and work products relating to the Services. |
23. | C ORPORATE C ITIZENSHIP |
By executing this Agreement, the Institution hereby re-confirms all representations and certifications made to Novartis through www.supplierdirectory.novartis.com , if any, or otherwise in writing. Institution understands and agrees that (i) Novartis (1) has relied upon the accuracy and veracity of such representations and certifications; and (2) may use data from the same in submissions to the Federal government or other governmental authorities; and (ii) any misrepresentation in connection therewith shall constitute a material breach of this Agreement. Novartis endorses societal and environmental values as set forth in the Novartis Policy on Corporate Citizenship, Third Party Code of Conduct: (accessible at http://www.corporatecitizenship.novartis.com/downloads/business-conduct/NovartisTP_Code.pdf) .
(Remaining Page Intentionally Left Blank)
12
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their respective duly authorized representatives as of the day and year first above written.
N OVARTIS P HARMACEUTICALS C ORPORATION | F OUNDATION M EDICINE , I NC . | |||
/s/ William Candido |
/s/ Kevin Krenitsky |
|||
(signature) | (signature) | |||
William Candido |
Kevin Krenitsky |
|||
(name printed) | (name printed) | |||
Assoc. Director, OTM Research Alliances |
COO |
|||
(title) | (title) | |||
11/28/11 |
11/28/11 |
|||
(date) | (date) | |||
N OVARTIST P HARMACEUTICALS C ORPORATION | ||||
/s/ Lothar H. Finke |
||||
(signature) | ||||
Lothar H. Finke |
||||
(name printed) | ||||
Vice President, OTM |
||||
(title) | ||||
30 Nov. 2011 |
||||
(date) |
13
ATTACHMENT 1
(Sample)
TASK ORDER
14
Task Order #
INSTITUTION
This Task Order No. XX (Task Order XX ) shall be binding upon the undersigned upon its execution by the duly authorized representative (s) of Novartis and Institution. It is subject to the terms of that certain Laboratory Master Services Agreement between Novartis Pharmaceuticals Corporation, with an office at 59 Route 10, East Hanover, NJ 07936 and INSTITUTION dated November 21, 2011 (Agreement).
1. CONTRACT RESEARCH-RELATED INFORMATION
Test Compound and Study No.: | SAMPLE | |
Protocol Title |
2 RESPONSIBILITIES OF INSTITUTION
Pursuant to 21 CFR 312.52, if and as applicable, Novartis and the Institution agree that the Institution, either exclusively or jointly with Novartis or its authorized agent(s), shall have the responsibilities and shall perform the tasks as specified in the Study Specifications Worksheet attached hereto as Schedule B and incorporated herein by reference.
(this space intentionally blank)
3. NOTICE
Any notice required or permitted hereunder shall be in writing and shall be deemed given as of the date if it is (A) delivered by hand or (B) delivered by registered or certified mail, postage prepaid, return receipt request, and addressed to the party to receive such notice at the address set forth below, or such other address as is subsequently specified in writing, as well as any persons so designated under the Agreement itself. For the avoidance of doubt, a writing provided by E-mail shall not be deemed to comply with the notice requirements of this Task Order.
If to Novartis:
Technical Matters: | ||||
Administrative/Contractual Matters: | ||||
Invoicing/Payment Matters: |
Novartis Pharmaceuticals Corporation PO Box 5450 Portland, OR 97228-5450 |
US 1-866-240-3191 Intl 1-862-778-4241 |
If to Institution:
Technical Matters: | ||||
Administrative/Contractual Matters: | ||||
Invoicing/Payment Matters: |
4. MODIFICATIONS AND ADDITIONAL TERMS FOR THIS CONTRACT SERVICES:
[CAUTION : The provisions of this section supersede any conflicting provisions of the Laboratory Master Services Agreement.]
The Services shall be provided in accordance with the terms set forth in the proposal submitted by Institution to Novartis on [ Insert Date ], which proposal shall be made a part of this Task Order XX and incorporated by reference herein.
5. EFFECTIVE PERIOD:
The effective period of this Task Order shall be from XXX until XXX , (Agreement Period). This agreement period may be extended by mutual written agreement of both parties.
6. LIST OF ATTACHMENTS:
|
PO Summary & Payment Schedule (Schedule A) |
|
Study Specifications Worksheet or Statement of Work (Schedule B) |
|
Institution Proposal/Change Order (as applicable) and/or Budget (Schedule C) |
7. COST AND PAYMENT
Payment shall be made to the Institution according to Schedule A appended hereto and incorporated herein by reference. All costs outlined on Schedule A shall remain firm for the duration of the Services, unless otherwise agreed to in writing by the Institution and Novartis.
All invoices for Services must be received within ninety (90) days of the expiration or termination of the applicable Task Order. In no event shall Novartis be obligated to pay any invoice received by it more than six (6) months after the expiration or termination of the applicable Task Order.
(this space intentionally blank)
In Witness Whereof , the parties hereto have executed this Task Order XX in duplicate by proper persons thereunto duly authorized
SCHEDULE A - Sample
ATTACHMENT 2
(Sample)
AFFILIATE AGREEMENT
The undersigned affiliate of Novartis Pharmaceuticals Corporation (Novartis Affiliate) wishes to benefit from the negotiated terms and conditions of the Laboratory Master Services Agreement entered into by the Institution and Novartis Pharmaceuticals Corporation dated {insert the date of the Laboratory Master Services Agreement} and, if applicable, Task Order(s) {Insert Task Order Number(s)} dated {insert the date(s) of the Task Order(s)} entered into in accordance with said Agreement. Accordingly, upon execution of this Affiliate Agreement, the terms and conditions of said Laboratory Master Services Agreement {add, if applicable, and said Task Orders} shall be considered incorporated into this Affiliate Agreement as if set forth at length herein, provided, however, that, for purposes of this Affiliate Agreement, any and all references to Novartis Pharmaceuticals Corporation in said Laboratory Master Services Agreement {add, if applicable, and said Task Orders} shall be deemed to be references to the undersigned Novartis Affiliate for purposes of this Affiliate Agreement and any applicable Task Order(s) issued hereunder.
The undersigned Novartis Affiliate and the Institution agree that they are executing this Affiliate Agreement solely on their own behalves. Consequently, in no event shall Novartis Pharmaceuticals Corporation be liable for any obligations of the Novartis Affiliate under this Affiliate Agreement or any Task Order(s) subsequently executed by and between the Novartis Affiliate and the Institution hereunder as the Institution will look exclusively to the Novartis Affiliate in relation to any rights or remedies it may have under or with respect to this Affiliate Agreement, nor shall Institution be liable to Novartis Pharmaceuticals Corporation for any obligations under this Affiliate Agreement or any Task Order(s) subsequently executed by and between the Novartis Affiliate and the Institution.
|
{Insert the name of the Novartis Affiliate} |
By: |
|
|
(signature) | ||
|
||
(print or type name) | ||
Title: |
|
|
Date: |
|
|
F OUNDATION M EDICINE , I NC . | ||
By: |
|
|
(signature) | ||
|
||
(print or type name) | ||
Title: |
|
|
Date: |
|
ATTACHMENT 3
[ *** ] PRICING
One Kendall Square Suite 63501 Cambridge, MA 02139
T (617) 41B-220O F (617) 418 2201
www.foundationmedicine.com |
June 14,2011
Barbara L Weber, MD
Senior Vice President & Global Head
Oncology Translations Medicine
Novartis Institutes for BioMedical Research
250 Massachusetts Avenue, Building 3A/246
Cambridge, MA 02135
Dear Barbara,
Thank you for meeting with me on Monday to discuss the Novartis - Foundation Medicine partnership and how we can best work together. We are committed to developing a strong partnership with Novartis and to demonstrate this commitment, we have provided [ *** ]. Please find the volume-based pricing tiers listed below:
[ *** ] Volumes |
Per Sample Pricing | |||
[ *** ] |
[ *** | ] | ||
[ *** ] |
[ *** | ] | ||
[ *** ] |
[ *** | ] | ||
[ *** ] |
[ *** | ] | ||
[ *** ] |
[ *** | ] | ||
[ *** ] |
[ *** | ] |
I look forward to working closely with you in the future.
Best Regards,
Michael Pellini, M D
President and CEO
Foundation Medicine, Inc.
***Confidential Treatment Requested
FIRST AMENDMENT TO
LABORATORY MASTER SERVICES AGREEMENT
This First Amendment to Laboratory Master Services Agreement (this Amendment), dated as of the 29 th of May, 2012 (the Amendment Effective Date), is entered into by and between Novartis Pharmaceuticals Corporation (Novartis) with an office at 59 Route 10, East Hanover, NJ 07936, and Foundation Medicine, Inc. (Institution), with an office at One Kendall Square, Suite B6S01, Cambridge, MA 02139, and amends the Laboratory Master Services Agreement dated as of November 21, 2011 (the Master Agreement). Capitalized terms used in this Amendment and not otherwise defined herein are used with the meanings ascribed to them in the Master Agreement.
1. | New Sections 1.C, 1.D and 1.E. Section 1 of the Master Agreement is hereby amended by adding Sections 1.C, 1.D and 1.E as follows: |
C. Within ninety (90) days of the Amendment Effective Date, the parties shall collaborate in good faith to discuss [ *** ].
D. Novartis acknowledges that Institution is currently working on a clinical trial with US Oncology relating to the use of the Institutions current Commercial Panel Product in the community oncology setting To the extent that (a) the performance of the Services provides either (i) information about a Novartis product that is either current in clinical trials or (ii) information about a potential off-label use of a Novartis product; and (b) an oncologist at US Oncology is interested in prescribing such Novartis product, then Institution and Novartis shall collaborate in good faith to determine an appropriate course of action.
E. For each new protocol identified in any Task Order, the parties shall discuss and agree on a reasonable and appropriate turn-around time goal for provision of the Services on Samples once received by the Institution.
2. | New Section 1.1. A new Section 1.1 is hereby added to the Master Agreement as follows: |
Section 1.1. Steering Committee
A. The parties shall establish a joint steering committee (the JSC), and shall consist of four (4) members, two (2) of whom shall be designated by Novartis, and two (2) of whom shall be designated by Institution. The initial members of the JSC shall be agreed to by the parties. Novartis and Institution may replace any or all of its representatives on the JSC at any time upon written notice to the other party. A party may designate a substitute to temporarily attend and perform the functions of such partys designee at any meeting of the JSC; provided, however, that such designee shall have appropriate expertise. The Chairman of the JSC shall be a representative of Novartis.
***Confidential Treatment Requested
F IRST A MENDMENT
B. The JSC shall meet quarterly, or with such other frequency, and at such time arid location, as may be established by the JSC, for the following purposes: (1) to facilitate communication between the parties with regard to the Services so that each party is kept reasonably informed of the status of the Services; (2) general oversight of the entire collaboration between the parties; and (3) periodically review and set the overall goals and strategy of the Services.
C. The JSC may make decisions with respect to any subject matter that is subject to the JSCs decision-making authority and responsibilities as set forth in Section 1.1.B. Regardless of the number of individuals attending any JSC meeting, Novartis and Institution shall have a single vote each. The JSC shall attempt in good faith to reach unanimity with respect to matters that come before it for decision and shall give consideration to the views, positions and recommendations of each party on such matters. If the JSC is unable to reach unanimity upon any issue or matter that is brought before it for decision within thirty (30) days after consideration by the JSC then, and in each such event, the JSC shall refer such issue or matter to the parties for resolution.
3. | Section 2. Section 2 of the Master Agreement is hereby replaced with the following: |
Section 2. Term of Agreement.
Unless sooner terminated pursuant to the terms of this Agreement, this Agreement shall be deemed effective from as of the Amendment Effective Date and shall continue in force until May 1, 2015. Notwithstanding the foregoing, (a) any Task Orders issued by Novartis to Institution prior to the Amendment Effective Date shall be governed by the terms of this Agreement, as amended herein; and (b) should any Task Orders entered into during the term of this Agreement require Services to be performed beyond the termination date of this Agreement, then the terms of this Agreement shall remain in effect with respect to such Task Orders until the termination of the Task Orders.
4. | Section 3.A. Section 3.A of the Master Agreement is hereby replaced with the following: |
A. In consideration of the satisfactory performance of the Services, Novartis shall pay Institution in accordance with each Task Order and the pricing set forth on Schedule 1, as further described below. Unless Novartis reasonably objects to all or a portion of any invoice submitted to it by Institution, Novartis shall make payments against each invoice within sixty (60) days of its receipt.
a) During the period from [ *** ] until [ *** ], Novartis shall pay Institution for a minimum of [ *** ] Samples (the First and Second Year Minimum). During the period from [ *** ] until [ *** ], Novartis shall pay Institution for a minimum of [ *** ] Samples (the Third Year Minimum and together with the First and Second Year Minimum, each a Contract Year Minimum), [ *** ]. For purposes of this Agreement, a Contract Year shall mean the period of time from May 1 st of one year to April 30 th of the next succeeding year, and a Contract Quarter means each three (3) month period starting on May 1 st , August 1 st , November 1 st and February 1 st .
***Confidential Treatment Requested
23
F IRST A MENDMENT
b) Without limiting the foregoing paragraph, to ensure the provision of timely Services from Institution, within thirty (30) days after the Amendment Effective Date and thirty (30) days prior to start of each Contract Quarter, Novartis shall provide Institution with a good faith estimate of Novartis estimated Sample volumes for the following four (4) Contract Quarters.
c) During each Contract Year, Novartis shall pay Institution to support [ *** ] FTE to serve as the Novartis project manager at Institution in support of the Services under this Agreement. The FTE rate shall be equal to [ *** ] (the FTE Rate), which FTE Rate shall be payable as part of a Quarterly Payment as set forth in Section 3.A(d). Except as set forth in this Section 3.A(c), Institution bears the sole responsibility for compensation (including overtime to hourly employees, if applicable) of Institutions employees.
d) Novartis shall pay to Institution Contract Quarter payments for each Contract Year as set forth in the table below, to account for the Contract Year Minimums and the FTE support as provided for above (the Quarterly Payments). The Quarterly Payments shall be invoiced by Institution to Novartis in the following amounts, and are non-refundable, non-creditable and not subject to set-off:
Contract Year | Payments |
Quarterly
Payment |
||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] | ||||
[ *** ] |
[ *** ] | [ *** ] |
* | For clarity, Novartis is obligated to make the Quarterly Payments specified above for the First Contract Year and Second Contract Year in all events, no matter the number of Samples sent to Institution, and notwithstanding the true-up calculation on Section 3.A(f) below. |
** | For further clarity, the Third Contract Year specified above is an example and shall be adjusted to reflect Third Year Minimum provided by Novartis above (this example assumes [ *** ] Samples for the Third Year Minimum). |
Institution shall invoice Novartis for the first Quarterly Payment for the First Year on May 1, 2012. Thereafter, Institution shall invoice Novartis for the Quarterly Payments on the first day of each Contract Quarter thereafter during the term of this Agreement.
e) During each Contract Year, Novartis shall endeavor to provide Samples to Institution on a regular basis to ensure the best turnaround times for the Services performed by Institution. If during any Contract Year the value of the Services performed to date materially exceeds the Quarterly Payments already made by Novartis, the parties agree to discuss accelerating payments by Novartis for that Contract Year. Further, if during the First and Second Contract Year together or the Third Contract Year the number of Samples provided by Novartis exceed the applicable Contract Year Minimum, then Institution shall bill Novartis for
***Confidential Treatment Requested
24
F IRST A MENDMENT
any excess Samples when the Services are performed on such Sample. Notwithstanding anything in this Agreement to the contrary, Novartis will not provide more than [ *** ] samples to Institution during any Contract Quarter during the term of this Agreement, without Institutions prior approval.
f) At the end of each Contract Year, there shall be a true-up performed as follows to take account of any price adjustment based on the number of Samples for that Contract Year based on Schedule 1: Institution shall recalculate the total cost to Novartis based on the number of Samples shipped by Novartis to Institution in that Contract Year and Schedule 1 (including the FTE support specified in Section 3.A(c)), and if the amounts paid by Novartis for that Contract Year exceed the amounts owed based on that recalculation, then Institution shall provide a credit on any remaining invoices applicable to that Contract Year, and if such credit on such invoices does not account for the full credit, Institution shall provide a credit (but not a refund) for the next Contract Year. Notwithstanding the foregoing, in no event shall the annual total of the Quarterly Payments for any Contract Year give rise to any credit for any future Contract Year or any refund or right or set-off, so that only if Novartis sends more Samples in the First and Second Contract Year together or the Third Contract Year than the applicable Contract Year Minimum could there be the possibility of any credit based on this Section 3.A(f).
g) The parties acknowledge and agree that Samples provided by Novartis to Institution under Task Order #1 [ *** ] and Task Order #2 [ *** ] shall be governed by the terms of this Agreement, as amended. Thus, although some of those Samples under those Task Orders have already been run, all of those Samples shall be included in the First Year.
5. | Section 4.D. Section 4.D of the Master Agreement is hereby amended as follows: the phrase or on behalf of Institution or by is hereby added after the clause based on any discovery made by. |
6. | Section 4.D. Section 4.D of the Master Agreement is hereby amended as follows: the word Results is hereby replaced by Works or Component Improvements. |
7. | Section 4.H. Section 4.H of the Master Agreement is hereby amended as follows: the phrase licenses, rights and is hereby added before the word obligations. |
8. | New Section 4.I. Section 4 of the Master Agreement is hereby amended by adding Sections 4.I and as follows: |
[ *** ]
1. | Novartis will grant to Institution [ *** ]. |
2. |
[ *** ] |
***Confidential Treatment Requested
25
F IRST A MENDMENT
9. | Section 10.A. The first sentence of Section 10.A of the Master Agreement is hereby amended as follows: |
A. This Agreement and any Task Orders issued hereunder may be terminated by Novartis for any reason or for no reason at all after [ *** ] upon one hundred twenty (120) days written notice to Institution.
10. | Press Release. Upon execution of this Amendment, Institution shall issue a press release in a form mutually agreed to by the parties announcing the full partnership established by the Master Agreement (including the three-year term), as amended by this Amendment. |
11. | Entire Agreement. Except as provided herein, the Master Agreement shall remain in full force and effect without amendment or modification and is hereby ratified. The Master Agreement, as amended by this Amendment, supersedes any prior understandings or written or oral agreements between the parties respecting the subject matter hereof and contains the entire understanding of the parties with respect thereto. This Amendment shall not have any force or effect until executed by all parties. The headings of this Amendment are for informational purposes only and shall not be used to interpret this Amendment |
12. | Counterparts. This Amendment may be executed in multiple counterparts, each of which shall be deemed to be an original agreement and all of which taken together shall constitute one agreement. This Amendment may also be executed by facsimile counterparts. |
[ remainder of this page intentionally left blank ]
***Confidential Treatment Requested
26
F IRST A MENDMENT
SCHEDULE 1
The pricing shall be determined by using the following volume-based pricing tiers:
[ *** ] Volumes Per Sample Pricing
[ *** | ] | [ *** ] | ||||||
[ *** | ] | [ *** ] | ||||||
[ *** | ] | [ *** ] | ||||||
[ *** | ] | [ *** ] | ||||||
[ *** | ] | [ *** ] | ||||||
[ *** ] |
Notwithstanding the foregoing, the parties agree that the pricing for Samples provided by Novartis to Institution during each of the First Contract Year and the Second Contract Year shall be [ *** ] for up to [ *** ] Samples, and [ *** ] if more than [ *** ] Samples in the applicable Contract Year.
***Confidential Treatment Requested
F IRST A MENDMENT
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed by their respective duly authorized representatives as of the day and year first above written.
NOVARTIS PHARMACEUTICALS CORPORATION | FOUNDATION MEDICINE, INC | |||
/s/ Barbara L. Weber, M.D. |
/s/ Michael J. Pellini, M.D. |
|||
Name: Barbara L. Weber, M.D. | Name: Michael J. Pellini, M.D. | |||
Title: SVP, Oncology Translational Medicine | Title: President & CEO | |||
Date: 29 May 2012 | Date: 29 May 2012 | |||
/s/ Herve Hoppenot |
||||
Name: Herve Hoppenot | ||||
Title: President, Oncology Business Unit | ||||
Date: 7 June 2012 |