Document:

Exhibit 10.7

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

EXCLUSIVE LICENSE AGREEMENT

 

between

 

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

 

and

 

SINGULEX, INC.

 

for

 

HIGHLY SENSITIVE SYSTEM AND METHODS FOR ANALYSIS OF TROPONIN

 

UC Case No. 2008-042

 

 

TABLE OF CONTENTS

 

	
Article No.
    	
 
    	
Title
    	
 
    	
Page
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
BACKGROUND
    	
 
    	
2
    
	
 
    	
 
    	
 
    	
 
    
	
1.     DEFINITIONS
    	
 
    	
3
    
	
 
    	
 
    	
 
    
	
2.     GRANT
    	
 
    	
10
    
	
 
    	
 
    	
 
    
	
3.     SUBLICENSES
    	
 
    	
11
    
	
 
    	
 
    	
 
    
	
4.     PAYMENT TERMS
    	
 
    	
12
    
	
 
    	
 
    	
 
    
	
5.     LICENSE ISSUE FEE
    	
 
    	
14
    
	
 
    	
 
    	
 
    
	
6.     PAYMENTS ON SUBLICENSES
    	
 
    	
14
    
	
 
    	
 
    	
 
    
	
7.     EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES
    	
 
    	
15
    
	
 
    	
 
    	
 
    
	
8.     MILESTONE PAYMENTS
    	
 
    	
15
    
	
 
    	
 
    	
 
    
	
9.     DUE DILIGENCE
    	
 
    	
16
    
	
 
    	
 
    	
 
    
	
10.          PROGRESS AND ROYALTY REPORTS
    	
 
    	
17
    
	
 
    	
 
    	
 
    
	
11.          BOOKS AND RECORDS
    	
 
    	
20
    
	
 
    	
 
    	
 
    
	
12.          LIFE OF THE AGREEMENT
    	
 
    	
21
    
	
 
    	
 
    	
 
    
	
13.          TERMINATION BY THE REGENTS
    	
 
    	
22
    
	
 
    	
 
    	
 
    
	
14.          TERMINATION BY LICENSEE
    	
 
    	
23
    
	
 
    	
 
    	
 
    
	
15.          DISPOSITION OF LICENSED PRODUCT AND LICENSED SERVICES UPON   TERMINATION OR EXPIRATION
    	
 
    	
23
    
	
 
    	
 
    	
 
    
	
16.          USE OF NAMES AND TRADEMARKS
    	
 
    	
24
    
	
 
    	
 
    	
 
    
	
17.          LIMITED WARRANTY
    	
 
    	
24
    
	
 
    	
 
    	
 
    
	
18.          LIMITATION OF LIABILITY
    	
 
    	
25
    
	
 
    	
 
    	
 
    
	
19.          PATENT PROSECUTION AND MAINTENANCE
    	
 
    	
26
    
	
 
    	
 
    	
 
    
	
20.          PATENT MARKING
    	
 
    	
28
    
	
 
    	
 
    	
 
    
	
21.          PATENT INFRINGEMENT
    	
 
    	
28
    

 

 

	
22.          INDEMNIFICATION
    	
 
    	
30
    
	
 
    	
 
    	
 
    
	
23.          NOTICES
    	
 
    	
31
    
	
 
    	
 
    	
 
    
	
24.          ASSIGNABILITY
    	
 
    	
32
    
	
 
    	
 
    	
 
    
	
25.          WAIVER
    	
 
    	
33
    
	
 
    	
 
    	
 
    
	
26.          FORCE MAJEURE
    	
 
    	
33
    
	
 
    	
 
    	
 
    
	
27.          GOVERNING LAWS; VENUE; ATTORNEYS’ FEES
    	
 
    	
33
    
	
 
    	
 
    	
 
    
	
28.          GOVERNMENT APPROVAL OR REGISTRATION
    	
 
    	
34
    
	
 
    	
 
    	
 
    
	
29.          COMPLIANCE WITH LAWS
    	
 
    	
34
    
	
 
    	
 
    	
 
    
	
30.          CONFIDENTIALITY
    	
 
    	
34
    
	
 
    	
 
    	
 
    
	
31.          MISCELLANEOUS
    	
 
    	
36
    

 

44

 

EXCLUSIVE LICENSE AGREEMENT

 

for

 

HIGHLY SENSITIVE SYSTEM AND METHODS FOR ANALYSIS OF TROPONIN

 

This license agreement (“Agreement”) is made effective this 1st day of November, 2008 (“Effective Date”), by and between The Regents of the University of California, a California corporation, having its statewide administrative offices at 1111 Franklin Street, 12th Floor, Oakland, California 94607-5200 (“The Regents”), acting through its Office of Technology Management, University of California San Francisco, 185 Berry Street, Suite 4603, San Francisco, California 94107 (“UCSF”), and Singulex, Inc., a Delaware corporation, having a principal place of business at 1650 Harbor Bay Parkway, Suite 200, Alameda, California 94502 (“Licensee”).

 

BACKGROUND

 

A.    Certain inventions, generally characterized as highly sensitive system and methods for analysis of Troponin (UCSF Case nos. SF2008-042 and SF2009-027, collectively “Invention”), were made in the course of research at the University of California, San Francisco, by Dr. Alan Wu and at Singulex by Philippe Goix, Robert Puskas, John Todd, Richard Livingston, and Douglas Held, and are claimed in Patent Rights as defined below.

 

B.    The Licensee wishes to obtain certain rights from The Regents for the commercial development of the Invention, in accordance with the terms and conditions set forth herein and The Regents is willing to grant those rights so that the Invention may be developed and the benefits enjoyed by the general public.

 

C.    The scope of such rights granted by The Regents is intended to extend to the scope of the patents and patent applications in Patent Rights, but only to the extent that The Regents has proprietary rights in and to the Valid Claims of such Patent Rights.

 

D.    The Licensee is a “small business firm” as defined in 15 U.S.C. §632.

 

E.     Both parties recognize and agree that Earned Royalties are due under this Agreement with respect to products, services and methods and that such royalties will be paid by Licensee

 

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on any claim in both pending patent applications and issued patents, in accordance with the terms and conditions set forth herein, provided that such a claim is a Valid Claim.

 

F.     Both parties recognize and agree that Earned Royalties due under this Agreement will be based on the Licensee’s or a Sublicensee’s last act of infringement of Patent Rights within the control of the Licensee or a Sublicensee, regardless of whether the Licensee or a Sublicensee had control over prior infringing acts; the parties intend that Earned Royalties due under this Agreement will be calculated based on the Net Sales of the product or service resulting from the last act of infringement by the Licensee and its Sublicensees.

 

- - oo 0 oo - -

 

The parties agree as follows:

 

1.     DEFINITIONS

 

As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

 

1.1 “Affiliate” of the Licensee means any entity which, directly or indirectly, Controls the Licensee, is Controlled by the Licensee or is under common Control with the Licensee.  “Control” means (i) having the actual, present capacity to elect a majority of the directors of such affiliate; (ii) having the power to direct at least forty percent (40%) of the voting rights entitled to elect directors; or (iii) in any country where the local law will not permit foreign equity participation of a majority, ownership or control, directly or indirectly, of the maximum percentage of such outstanding stock or voting rights permitted by local law.

 

1.2 “Attributed Income” means the total gross proceeds (exclusive of Earned Royalties of Sublicensees, but including, without limitation, any license fees, maintenance fees, or milestone payments), consisting of cash (and securities received in lieu of the foregoing cash payments), received by the Licensee, any Affiliate and/or Joint Venture from any Sublicensee in consideration of the grant of a sublicense under the Patent Rights.  Notwithstanding the foregoing, Attributed Income shall not include proceeds reasonably and fairly attributed in such sublicense to bona fide (i) debt financing; (ii) equity (and conditional equity, such as warrants,

 

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convertible debt and the like) investments in the Licensee, Affiliate or Joint Venture at market value; (iii) reimbursements of Patent Prosecution Costs and (iv) reimbursement for the cost of research , development and/or other services including manufacturing services for clinical trials, e.g., conducted by Licensee or on behalf of Licensee and provided on the basis of full-time equivalent (“FTE”) efforts of personnel at or below commercially reasonable and standard FTE rates (“FTE Reimbursements”) and/or the reimbursement of out-of-pocket costs, all to the extent attributable to Licensed Products or Licensed Services under this Agreement as shown by written record; (v) profit or revenue sharing on sales of goods already subject to an Earned Royalty (however the Earned Royalty paid shall be set based upon a Net Sales Price set at a level commensurate with an arm’s length transaction); (vi) Eligible Expenses; (vii) withholding taxes and other amounts actually withheld from or deducted against the amounts paid to such Party; (viii) income for commercial manufacturing of goods if sales of such goods are already subject to an Earned Royalty (however the Earned Royalty paid shall be set based upon a Net Sales Price set at a level commensurate with an arm’s length transaction); and (ix) any consideration received for the grant of any rights other than Patent Rights as agreed by the parties pursuant to Paragraph 6.2.  It is not the intent of the parties for The Regents to be paid twice on any single unit of product.  For such purposes, “Eligible Expenses” means (i) the documented costs and expenses reasonably incurred by Licensee, its Affiliates or a Joint Venture (the “Licensing Party”) in performing research, development, and/or manufacture of Licensed Products prior to and/or after the date of the agreement with the Sublicensee under a sublicense to Patent Rights, including FTE Reimbursements and out-of-pocket costs to the extent attributable to Licensed Products or Licensed Services under this Agreement as shown by written record.

 

1.3 “Combination Product” means a combined Product that contains or uses a Licensed Product and at least one other Product or process (a “Combination Product Component”), where (i) such Combination Product Component is not a Licensed Product, (ii) if such Combination Product Component were removed from such combined Product, the manufacture, use, Sale or import of the resulting Product in or into a particular country would infringe, but for a license, the same Valid Claim in the country where such manufacture, use, Sale or import occurs as such combined Product, (iii) such Combination Product Component and such Licensed Product are Sold separately from such combined Product by Licensee or any Affiliate, Joint Venture or

 

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Sublicensee, (iv) such Combination Product Component does not function together with a Licensed Product so as to achieve the purpose for which such Licensed Product is Sold and (v) the market price of such combined Product is higher than the market price for such Licensed Product (if Sold separately) as a result of such combined Product containing or using such Combination Product Component.

 

1.4 “Earned Royalty” means Sublicensee Royalty (as defined in Paragraph 6.3) and Royalty (as defined in Paragraph 7.1)

 

1.5 “Field of Use” means all fields.

 

1.6 “FTE” is defined in Paragraph 1.2 (Attributed Income).

 

1.7 “Joint Venture” means any separate entity established pursuant to a written agreement between a third party and the Licensee and/or Sublicensee to constitute a vehicle for a joint venture, in which the separate entity manufactures, uses, purchases, Sells or acquires Licensed Products from the Licensee or Sublicensee.

 

1.8 “Licensed Method” means any process, art or method the use or practice of which, but for the license granted in this Agreement, would infringe, or contribute to, or induce the infringement of, any Patent Rights in any country were they issued at the time of the infringing activity in that country.

 

1.9 “Licensed Product” means any Product, including, without limitation, a Product for use or used in practicing a Licensed Method and any Product made by practicing a Licensed Method, the manufacture, use, Sale, offer for Sale or import of which, but for the license granted in this Agreement, would infringe, or contribute to, or induce the infringement of, any Patent Rights in any country were they issued at the time of the infringing activity in that country. Without limiting the generality of the foregoing, any Product (including any Combination Product) containing or using a Patent Product shall be deemed a Patent Product in its entirety, provided that Net Sales for any such Combination Product shall be calculated as described in Article 1.12 below.

 

1.10       “Licensed Service” means any service provided for consideration (whether in cash or any other form having financial value), when such service (i) involves the use of a Licensed Product; or (ii) involves the practice of a Licensed Method.  Notwithstanding the foregoing, it is understood that Licensed Service shall not include any service involving or performed in

 

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connection with the research or development of a Licensed Product by or for the Licensee or any Affiliate, Joint Venture, or Sublicensee.

 

1.11       “Net Invoice Price” means (a) the gross invoice price charged and the value of any other consideration owed to the Licensee, its Affiliates, Joint Ventures, or any Sublicensees  for Sale of a Licensed Product or Licensed Service, or (b) in those instances where the Licensed Product or Licensed Service is combined in any manner with any other Product or service, the gross  invoice price charged and the value of any other consideration owed to the Licensee, its Affiliates, Joint Ventures, and/or Sublicensees for Sale of the combined Product or service in its entirety, which shall be subject to the Combination Product Net Sales language below , in each case less (i) an allowance, in the form of a credit, only for those accounts deemed in good faith to be uncollectible by Licensee that have been outstanding for at least six (6) months and for which Licensee has sent two (2) overdue notices by return receipt mail or for which the customer has not paid following efforts by a collection agency over a period of six (6) months, and (ii) the following items, but only to the extent that they actually pertain to the disposition of such Licensed Product or Licensed Service, are included in the gross invoice price charged or other consideration owed,and are  separately billed:

 

1.11.1      Allowances actually granted to customers for rejections, returns and prompt payment and volume discounts;

 

1.11.2      Freight, transport packing and insurance charges associated with transportation;

 

1.11.3      Taxes, including Deductible Value Added Tax, tariffs or import/export duties based on Sales when included in the gross invoice price, but excluding value-added taxes other than Deductible Value Added Tax or taxes assessed on income derived from Sales.  “Deductible Value Added Tax” means value added tax only to the extent that such value added tax is actually incurred and is not reimbursable, refundable or creditable under the tax authority of any country;

 

1.11.4      Discounts and rebates given as a part of a formulary program that are paid or credited to customers, third-party payers, healthcare systems, or administrators

 

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for a Licensed Product or Licensed Service that is included in such formulary program, as permitted by applicable law;

 

1.11.5      Wholesaler’s discounts and rebates given as a part of a formulary program that are paid or credited to customers, third-party payers, health care systems, or administrators for a Licensed Product or Licensed Service that is included in such formulary program, as permitted by applicable law; and

 

1.11.6      Rebates and discounts paid or credited pursuant to applicable law.

 

1.12     “Net Sale” means:

 

1.12.1      except in the instances described in Paragraphs 1.12.2, 1.12.3 and 1.12.4 of this Paragraph, the Net Invoice Price;

 

1.12.2      for any Relationship-Influenced Sale of a Licensed Product or Licensed Service, Net Sales shall be based on the Net Invoice Price at which the Relationship-Influenced Sale Purchaser re-Sells such Licensed Product or Licensed Service unless such Relationship-Influenced Sale Purchaser does not re-Sell such Licensed Product or Licensed Service, in which case,  the Net Sales for such Licensed Product or Licensed Service shall be the Net Invoice Price currently being offered for Sale by the Licensee or any Sublicensee in an arms length transaction.  In those instances where Relationship-Influenced Sale Purchaser combines such Licensed Product or Licensed Service in any manner with any other product or service, such combined product or service shall be considered a Combination Product;

 

1.12.3      in those instances where Licensee or any Sublicensee receives non-cash consideration in lieu of cash for the Sale, lease or other transfer of Licensed Product or Licensed Service to a third party pursuant to a written agreement, the Net Sales for such Licensed Product or Licensed Service shall be the Net Invoice Price of Products or Services of the same or similar kind and quality, Sold in similar quantities, currently being offered for Sale by the Licensee or any Sublicensee.  Where such Products or Services are not currently Sold or offered for Sale by the Licensee or any Sublicensee, then the Net Sales shall be

 

7

 

as reasonably agreed upon by The Regents and Licensee and/or such Sublicensee; and

 

1.12.4      in those instances where Licensee or Sublicensee reacquires and subsequently Sells Licensed Product or Licensed Service previously Sold by Licensee, its Affiliate, Joint Venture, or Sublicensee, Net Sales shall mean the Net Invoice Price upon Sale of such reacquired Licensed Product or Licensed Service by Licensee, its Affiliate, Joint Venture, or Sublicensee, less any amounts paid to The Regents on account of earlier Sale of the reacquired Licensed Product or Licensed Service.

 

For a Combination Product, Net Sales shall be calculated as: [***], provided, however, that in no event shall Net Sales for a Combination Product be less than [***] of Net Sales, calculated without regard to this formula, of the Licensed Product that is the Combination Product.

 

1.13       “New Developments” means inventions, or claims to inventions, which constitute advancements, developments or improvements, whether or not patentable and whether or not the subject of any patent application, which are not sufficiently supported by the specification of a previously-filed patent or patent application within the Patent Rights to be entitled to the priority date of the previously-filed patent or patent application.

 

1.14       “Patent Prosecution Costs” is defined in Paragraph 19.5.

 

1.15       “Patent Rights” means the Valid Claims of, to the extent assigned to or otherwise obtained by The Regents, the following United States patents and patent applications:

 

	
UC Case Number
    	
 
    	
United States Application Number or
   United States Patent Number
    	
 
    	
Filing or Issue Date
    
	
SF2008-042
    	
 
    	
11/784,213
    	
 
    	
April 4,   2007
    
	
SF2009-027
    	
 
    	
12/062,412
    	
 
    	
April 3,   2008
    

 

Patent Rights shall further include the Valid Claims of, to the extent assigned to or otherwise obtained by The Regents, the corresponding foreign patents and patent applications and any reissues, extensions, substitutions, continuations, divisions, and continuation-in-part applications (but only those Valid Claims in the continuation-in-part applications that are entirely supported in the specification and entitled to the priority date of the parent application).  This definition of Patent Rights excludes any rights in and to New Developments.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

8

 

1.16       “Product” means any kit, article of manufacture, composition of matter, material, compound, component or product.

 

1.17       “Related Party” means a corporation, firm or other entity with which, or individual with whom, the Licensee its Affiliates, Joint Ventures, and/or Sublicensees  (or any of their respective stockholders, subsidiaries or Affiliates) have any agreement, understanding or arrangement (for example, but not by way of limitation, an option to purchase stock or other equity interest, or an arrangement involving a division of revenue, profits, discounts, rebates or allowances) unrelated to the Sale or exploitation of the Licensed Products or Licensed Services without which such other agreement, understanding or arrangement, the amounts, if any, charged by the Licensee, its Affiliate, Joint Venture, or Sublicensee to such entity or individual for the Licensed Product or Licensed Service would be higher than the Net Invoice Price actually received, or if such agreement, understanding or arrangement results in the Licensee, its Affiliate, Joint Venture, or Sublicensee extending to such entity or individual lower prices for such Licensed Product or Licensed Service than those charged to others without such agreement, understanding or arrangement buying similar products or services in similar quantities.

 

1.18       “Relationship-Influenced Sale” means a Sale of a Licensed Product or Licensed Service between the Licensee , its Affiliates, Joint Ventures, and/or Sublicensees on the one hand and a Related Party on the other hand.

 

1.19       “Relationship-Influenced Sale Purchaser” means the purchaser of Licensed Product or Licensed Service in a Relationship-Influenced Sale.

 

1.20       “Sale” means the act of selling, leasing or otherwise transferring, providing, or furnishing for use for any consideration.  Correspondingly, “Sell” means to make or cause to be made a Sale and “Sold” means to have made or caused to be made a Sale.

 

1.21       “Service Income” means Net Sales with respect to Licensed Services.

 

1.22       “Sublicensee” means any person or entity (including any Affiliate or Joint Venture) to which any of the license rights granted to the Licensee hereunder are sublicensed.

 

1.23       “Sublicense Fee” is defined in Paragraph 6.1.

 

1.24       “Valid Claim” means a claim of a patent or patent application in any country that (i) has not expired; (ii) has not been disclaimed; (iii) has not been cancelled or superseded, or if cancelled or superseded, has been reinstated; and (iv) has not been revoked, held invalid, or

 

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otherwise declared unenforceable or not allowable by a tribunal or patent authority of competent jurisdiction over such claim in such country from which no further appeal has or may be taken.

 

2.     GRANT

 

2.1 Subject to the limitations and other terms and conditions set forth in this Agreement, The Regents grants to the Licensee a license under its rights in and to Patent Rights to make, use, Sell, offer for Sale and import Licensed Products and Licensed Services and to practice Licensed Services and Licensed Methods, in the United States and in other countries where The Regents may lawfully grant such licenses, only in the Field of Use.

 

2.2 Except as otherwise provided for in this Agreement, the license granted under Patent Rights in Paragraph 2.1 is exclusive.

 

2.3 The license granted in Paragraphs 2.1 and 2.2 is limited to methods and products that are within the Field of Use.  For other methods and products, the Licensee has no license under this Agreement.

 

2.4 Title in and to the Invention and Patent Rights and any rights, including any and all intellectual property rights relating thereto is not transferred to the Licensee under this Agreement.

 

2.5 The Regents reserves and retains the right (and the rights granted to the Licensee in this Agreement shall be limited accordingly) to make, use and practice the Invention and any technology relating to the Invention and to make and use any Products and to practice any process that is the subject of the Patent Rights (and to grant any of the foregoing rights to other educational and non-profit institutions) for educational and research purposes, including without limitation, any sponsored research performed for or on behalf of commercial entities and including publication and other communication of any research results.  For the avoidance of doubt, to the extent the Invention and any technology relating to the Invention are not the subject of the exclusive license under the Patent Rights granted to the Licensee hereunder, The Regents shall be free to make, use, Sell, offer to Sell, import, practice and otherwise commercialize and exploit (including to transfer, license to, or have exercised by, third parties) for any purpose whatsoever and in its sole discretion, such Invention and technology and any Products or processes that are the subject of any of the foregoing, except in each case to the extent such

 

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technology, Products or processes are covered by the Patent Rights and exclusively licensed to Licensee hereunder.  It is understood that no right or license is granted to The Regents hereunder to any intellectual property of Licensee.

 

3.     SUBLICENSES

 

3.1 The Regents also grants to the Licensee the right to sublicense to third parties (including to Affiliates and Joint Ventures) the rights granted to the Licensee hereunder, with no right to further sublicense except as provided below, as long as the Licensee has current exclusive rights thereto under this Agreement.  Licensee may grant its Sublicensee the right to further sublicense any of the rights exclusively granted to Licensee hereunder only to the extent necessary for the research, development, seeking of marketing or regulatory approvals, manufacture and/or commercialization of Licensed Product(s) and/or Licensed Methods.  Each Sublicensee must be subject to a written sublicense agreement.  All sublicenses will include all of the rights of, and will require the performance of all the obligations due to, The Regents (and, if applicable, the United States Government and other sponsors), other than those rights and obligations specified in Article 5 (License Issue Fee), Paragraph 7.2 (Minimum Annual Royalty) and Paragraphs 19.5 and 19.7 (reimbursement of Patent Prosecution Costs).  For the avoidance of doubt, Affiliates and Joint Ventures shall have no licenses under this Agreement unless such Affiliates and Joint Ventures are granted a sublicense. For the purposes of this Agreement, the operations of all Sublicensees shall be deemed to be the operations of the Licensee, for which the Licensee shall be responsible.

 

3.2 The Licensee will not separately grant a license to any third party under its rights without concurrently granting a license under The Regents’ rights on the terms and conditions described in this Article 3 (Sublicenses).

 

3.3 The Licensee will notify The Regents of each sublicense granted hereunder and will provide The Regents with a complete copy of each sublicense (along with a summary of the material terms of each such sublicense) and each amendment to such sublicense within thirty (30) days of issuance of such sublicense or such amendment.  The Licensee will collect from Sublicensees and pay to The Regents all fees, payments, royalties and the cash equivalent of any consideration due The Regents.  The Licensee will guarantee all monies due The Regents from

 

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Sublicensees. For clarity, if the Licensee grants a sublicense, or a Sublicensee grants a further sublicense, that contains a provision for payment of royalties by any Sublicensee [***].  The Licensee will require Sublicensees to provide it with copies of all progress reports and royalty reports in accordance with the provisions herein and the Licensee will collect and deliver all such reports due The Regents from Sublicensees.

 

3.4 If Licensee licenses patent rights assigned to or otherwise acquired by it (“Licensee’s Patent Rights”), and it believes, in good faith, that the recipient of such license will infringe Patent Rights in practicing the Licensee’s Patent Rights, then the Licensee will not separately grant a license to such recipient under Licensee’s Patent Rights without concurrently granting a sublicense under Patent Rights on the terms required under this Agreement.

 

3.5 Upon any expiration or termination of this Agreement for any reason, all sublicenses shall automatically terminate, unless The Regents, at its sole discretion, agrees in writing to an assignment to The Regents of any sublicense.  In the event of termination of this Agreement and if The Regents accepts assignment of any sublicense, The Regents will not be bound by any grant of rights broader than or will not be required to perform any obligation other than those rights and obligations contained in this Agreement.  Moreover, The Regents will have the sole right to modify each such assigned sublicense to include all of the rights of The Regents (and, if applicable, the United States Government and other sponsors) that are contained in this Agreement, including the payment of Earned Royalties directly to The Regents by the Sublicensee as if it were the Licensee at a rate that is no lower than the rate set forth in Article 7 (Earned Royalties and Minimum Annual Royalties) in accordance with Article 4 (Payment Terms).

 

4.     PAYMENT TERMS

 

4.1 Paragraphs 1.8, 1.9, 1.10 and 1.15 define Licensed Method, Licensed Product, Licensed Service and Patent Rights, so that Earned Royalties are payable on products and methods covered by both pending patent applications and issued patents.  Earned Royalties will accrue in each country for the duration of Patent Rights in that country and will be payable to The Regents when Licensed Products or Licensed Services are invoiced, or if not invoiced, when delivered or otherwise exploited by the Licensee or Sublicensee in a manner constituting a Net Sale as

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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defined in Paragraph 1.12.  Sublicense Fees with respect to any Attributed Income shall accrue to The Regents within thirty (30) days of the date that such Attributed Income is due to the Licensee.

 

4.2 The Licensee will pay to The Regents all Earned Royalties, Sublicense Fees and other consideration payable to The Regents quarterly on or before February 28 (for the calendar quarter ending December 31), May 31 (for the calendar quarter ending March 31), August 31 (for the calendar quarter ending June 30) and November 30 (for the calendar quarter ending September 30) of each calendar year.  Each payment will be for Earned Royalties, Sublicense Fees and other consideration which has accrued within the Licensee’s most recently completed calendar quarter.

 

4.3 All consideration due The Regents will be payable and will be made in United States dollars by check payable to “The Regents of the University of California” or by wire transfer to an account designated by The Regents.  The Licensee is responsible for all bank or other transfer charges.  When Licensed Products or Licensed Services are Sold for monies other than United States dollars, the Earned Royalties and other consideration will first be determined in the foreign currency of the country in which such Licensed Products or Licensed Services were Sold and then converted into equivalent United States dollars.  The exchange rate will be the average exchange rate quoted in the The Wall Street Journal during the last thirty (30) days of the reporting period.

 

4.4 Sublicense Fees and Earned Royalties on Net Sales of Licensed Products or Licensed Services occurring in and other consideration received in, any country outside the United States may not be reduced by any taxes, fees or other charges imposed by the government of such country, except those taxes, fees and charges allowed under the provisions of Article 1.12 (Net Sales).

 

4.5 Notwithstanding the provisions of Article 26 (Force Majeure) if at any time legal restrictions prevent the prompt remittance of Earned Royalties or other consideration owed to The Regents by the Licensee with respect to any country where a sublicense is issued or a Licensed Product or Licensed Service is Sold or otherwise exploited, then the Licensee shall convert the amount owed to The Regents into United States dollars and will pay The Regents directly from another source of funds in order to remit the entire amount owed to The Regents.

 

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4.6 In the event that any patent or claim thereof included within the Patent Rights is held invalid in a final decision by a court of competent jurisdiction and last resort and from which no appeal has or can be taken, then all obligation to pay royalties based on that patent or claim or any claim patentably indistinct therefrom will cease as of the date of final decision.  The Licensee will not, however, be relieved from paying any royalties that accrued before such final decision and the Licensee shall be obligated to pay the full amount of royalties due hereunder to the extent that The Regents licenses one or more Valid Claims within the Patent Rights to the Licensee with respect to Licensed Products or Licensed Services.

 

4.7 In the event that royalties, fees, reimbursements for Patent Prosecution Costs or other monies owed to The Regents are not received by The Regents when due, the Licensee will pay to The Regents interest at a rate of [***] interest per annum, provided that Licensee was timely invoiced by The Regents for such originally due monies.  Such interest will be calculated from the date payment was due until actually received by The Regents.  Such accrual of interest will be in addition to and not in lieu of, enforcement of any other rights of The Regents due to such late payment.

 

5.     LICENSE ISSUE FEE

 

The Licensee will pay to The Regents a license issue fee of twenty-five thousand dollars ($25,000) within thirty (30) days of the Effective Date.  This fee is non-refundable, non-cancelable and is not an advance or otherwise creditable against any royalties or other payments required to be paid under the terms of this Agreement.

 

6.     PAYMENTS ON SUBLICENSES

 

6.1 The Licensee will pay to The Regents the following non-refundable and non-creditable sublicense fees (“Sublicense Fees”) listed in Articles 6.1.1 to 6.1.2 from all Sublicensees except those Sublicense Fees received by Licensee from Licensee’s Affiliates due solely under such Licensee’s Affiliate’s sublicense from Licensee; provided, however, any Sublicensing Fees received by such Licensee’s Affiliate under a sublicense to a third party shall be subject to Articles 6.1.1 and 6.1.2 as if the Licensee’s Affiliate were the Licensee :

 

6.1.1        [***] of all Attributed Income attributable to any sublicense [***]; or

 

6.1.2        [***] of all Attributed Income attributable to any sublicense [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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6.2 In the event that Licensee executes a single sublicense for any of the rights granted to the Licensee hereunder and additional unrelated rights, The Regents and Licensee shall discuss a mutually acceptable adjustment to Sublicense Fees for such sublicense to account for such additional rights.

 

6.3 The Licensee will also pay to The Regents, with respect to each Sublicensee, an earned royalty of: (i) [***] of the Net Sales of each Licensed Product or Licensed Method; and (ii) [***] of the Net Sales of any Service Income (“Sublicensee Royalty”).

 

7.     EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES

 

7.1 The Licensee will also pay to The Regents an earned royalty of (i) [***] of the Net Sales of Licensed Product or Licensed Method by the Licensee or any Affiliate or  Joint Venture; and (ii) [***] of any Service Income of the Licensee, any Affiliate or  Joint Venture (“Royalty”).

 

7.1.1        In the event that any Licensed Product or Licensed Service falls under more than one of categories (i) or (ii) described in Article 7.1, [***] royalty rate applicable shall apply.

 

7.1.2        No more than one royalty shall be paid to The Regents with respect to each unit of Licensed Product, Licensed Service, or Licensed Method.

 

7.2 The Licensee will also pay to The Regents a minimum annual royalty of fifteen thousand dollars ($15,000) for the life of Patent Rights, beginning on the second anniversary of the Effective Date.  After the first payment of the minimum annual royalty, the minimum annual royalty will be paid to The Regents by February 28 of each year and will be credited against the Earned Royalty due for the calendar year in which the minimum payment was made.

 

8.     MILESTONE PAYMENTS

 

8.1 The Licensee will pay to The Regents the following non-refundable, non-creditable amounts:

 

8.1.1        Ten thousand dollars ($10,000) upon grant of first marketing approval for a Licensed Product by the FDA; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

15

 

8.1.2        Fifty thousand dollars ($50,000) upon aggregate net sales of [***] of all Licensed Products, Licensed Methods, and Licensed Services collectively by the Licensee, Affiliates, Joint Ventures, and Sublicensees.

 

8.2 For the avoidance of doubt, each such milestone payment will be payable regardless of whether the applicable milestone event has been achieved by the Licensee or any Affiliate, Joint Venture, or Sublicensee.

 

8.3 All milestone payments are due to The Regents within thirty (30) days of the occurrence of the applicable milestone event.

 

9.     DUE DILIGENCE

 

9.1 The Licensee, upon execution of this Agreement, will diligently proceed with the development, manufacture and Sale of Licensed Products and Licensed Services and will earnestly and diligently market the same after execution of this Agreement and in quantities sufficient to meet the market demands therefor.  Notwithstanding the foregoing, Licensee shall be deemed to have satisfied its diligence obligations with respect to this Paragraph 9.1 by the completion of those specific diligence obligations specified in Paragraph 9.3 within the timeframes established therefor including any extensions thereto in accordance with such Paragraph.

 

9.2 The Licensee will obtain all necessary governmental approvals in each country where Licensed Products and Licensed Services are manufactured, used, Sold, offered for Sale or imported.

 

9.3 The Licensee will:

 

9.3.1        submit an application for market approval, covering Licensed Product, to the United States FDA within five (5) year(s) of the Effective Date;

 

9.3.2        market Licensed Product or Licensed Service by June 30, 2010;

 

9.3.3        fill the market demand for Licensed Products and Licensed Services following commencement of marketing at any time during the exclusive period of this Agreement.

 

The Regents shall allow a maximum of two one-year extensions of the milestones listed in Articles 9.3.1 and 9.3.2, the particular milestone for which such delay is granted to be selected

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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by the Licensee prior to expiration of the time period for reaching that milestone.  Licensee’s selection of a milestone for extension shall be accompanied by a payment of $10,000 per each one year extension to The Regents.  If the milestone in Article 9.3.1 is extended in accordance with this Article 9.3, then the milestone in Article 9.3.2 shall be deemed extended by the same time period.  Notwithstanding the foregoing right of Licensee to extend the milestones set forth in Articles 9.3.1 and 9.3.2 for any or no reason upon payment by Licensee of $10,000 for each such extension in accordance with this Article 9.3, if a milestone is not achieved for reasons beyond the reasonable control of Licensee, then the Licensee and The Regents will agree upon an extension of such milestones to allow for such achievement without any obligation for Licensee to pay The Regents for such extension.

 

9.4 If the Licensee is unable to perform any of the above provisions, then The Regents has the right and option to either terminate this Agreement or reduce the exclusive license granted to the Licensee to a nonexclusive license in accordance with Paragraph 9.5 below.  This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Grant).

 

9.5 To exercise either the right to terminate this Agreement or to reduce the exclusive license granted to the Licensee to a non-exclusive license for lack of diligence required in this Article 9 (Due Diligence), The Regents will give the Licensee written notice of the deficiency.  The Licensee thereafter has sixty (60) days to cure the deficiency.  If The Regents has not received written tangible evidence satisfactory to The Regents that the deficiency has been cured by the end of the sixty (60)-day period, then The Regents may, at its option, terminate this Agreement immediately without the obligation to provide sixty (60) days’ notice as set forth in Article 13 (Termination by The Regents) or reduce the exclusive license granted to the Licensee to a non-exclusive license by giving written notice to the Licensee.

 

10.     PROGRESS AND ROYALTY REPORTS

 

10.1       Beginning on September 30, 2009, and semi-annually thereafter, the Licensee will submit to The Regents a written progress report as described in Paragraph 10.2 below covering the Licensee’s (and any Affiliates’, Joint Ventures’, or Sublicensee’s) activities related to the development and testing of all Licensed Products and Licensed Services and related to the obtaining of the governmental approvals necessary for marketing and the activities required and

 

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undertaken in order to meet the diligence requirements set forth in Article 9 (Due Diligence).  Progress reports are required for each Licensed Product and Licensed Service until the first Sale or other exploitation of that Licensed Product or Licensed Service occurs in the United States and shall be again required if Sales of such Licensed Product or Licensed Service are suspended or discontinued.

 

10.2       Progress reports submitted under Paragraph 10.1 shall include, but are not limited to, a detailed summary of the following topics so that The Regents will be able to determine the progress of the development of Licensed Products and Licensed Services and will also be able to determine whether or not the Licensee has met its diligence obligations set forth in Article 9 (Due Diligence) above (provided that it is understood and agreed that  1) Licensee shall not be obligated to include in any such reports information belonging to its Sublicensees to the extent that the disclosure of such information would constitute a violation of Licensee’s obligations of confidentiality to such Sublicensees and 2) Licensee shall include as a term in any sublicense the right to provide The Regents with all information necessary for The Regents to determine that Licensee has met its obligations under this Agreement provided, that, The Regents shall treat such information as the Proprietary Information of Licensee in accordance with Article 30 below:

 

10.2.1      summary of work completed as of the submission date of the progress report;

 

10.2.2      key scientific discoveries as of the submission date of the progress report;

 

10.2.3      summary of work in progress as of the submission date of the progress report;

 

10.2.4      current schedule of anticipated events and milestones, including those event and milestones specified in Article 9 (Due Diligence);

 

10.2.5      market plans for introduction of Licensed Products and Licensed Services including the anticipated and actual market introduction dates of each Licensed Product or Licensed Service;

 

10.2.6      Sublicensees’ activities relating to the above items, if there are any Sublicensees.

 

10.3       If the Licensee fails to submit a timely progress report to The Regents, then The Regents will be entitled to terminate this Agreement, but only after The Regents has provided Licensee notice of such failure and a reasonable opportunity to cure the failure, as provided in

 

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Article 13 of this Agreement.  If either party terminates this Agreement before any Licensed Products or Licensed Services are Sold or before this Agreement’s expiration, then a final progress report covering the period prior to termination must be submitted within thirty (30) days of termination or expiration.

 

10.4       The Licensee has a continuing responsibility to keep The Regents informed of the business entity status (small business entity status or large business entity status as defined by the United States Patent and Trademark Office) of itself, any Affiliates, Joint Ventures, or Sublicensees.  The Licensee will notify The Regents of any change of its status or that of any Affiliate, Joint Venture, or Sublicensee within thirty (30) days of the change in status.

 

10.5       The Licensee will report to The Regents the date of first Sale or other exploitation of a Licensed Product or Licensed Service in each country in its first progress and royalty reports following such first Sale of a Licensed Product or Licensed Service.

 

10.6       Beginning with the earlier of (i) the first Sale of a Licensed Product or Licensed Service or (ii) the first transaction that results in Sublicense Fees accruing to The Regents, the Licensee will make quarterly Earned Royalty and Sublicensee Fee reports to The Regents on or before each February 28 (for the quarter ending December 31), May 31 (for the quarter ending March 31), August 31 (for the quarter ending June 30) and November 30 (for the quarter ending September 30) of each year.  Each royalty and Sublicensee Fee report will cover Licensee’s most recently completed calendar quarter and will, at a minimum, show:

 

10.6.1      the gross invoice prices and Net Sales of Licensed Products or Licensed Services Sold or otherwise exploited (itemizing the applicable gross proceeds and any deductions therefrom), any Attributed Income (itemizing the applicable gross proceeds and any deductions therefrom) and any Service Income (itemizing the applicable gross proceeds and any deductions therefrom) due to the Licensee;

 

10.6.2      the quantity of each type of Licensed Product and/or Licensed Service Sold or otherwise exploited;

 

10.6.3      the country in which each Licensed Product and Licensed Service was made, used or Sold or otherwise exploited;

 

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10.6.4      the Earned Royalties, in United States dollars, payable with respect to Net Sales and Service Income;

 

10.6.5      the Sublicense Fees, in United States dollars, payable with respect to Attributed Income;

 

10.6.6      the method used to calculate the Earned Royalty, specifying all deductions taken and the dollar amount of each such deduction;

 

10.6.7      the exchange rates used, if any;

 

10.6.8      the amount of the cash and the amount of the cash equivalent of any non-cash consideration having financial value including the method used to calculate the non-cash consideration to the extent included in Net Sales or Attributed Income;

 

10.6.9      for each Licensed Product Sold and for each Licensed Service Sold, the specific Patent Rights identified by UC Case Number exercised by the Licensee or any Affiliate, Joint Venture, or Sublicensee in the course of making, using, selling, offering for Sale or importing such Licensed Product and/or using, selling or offering for Sale such Licensed Service; and

 

10.6.10    any other information reasonably necessary to confirm Licensee’s calculation of its financial obligations hereunder.

 

10.7       If no Sales of Licensed Products and Licensed Services have been made and no Licensed Products and Licensed Services have been otherwise exploited and no Attributed Income is due to the Licensee during any reporting period, then a statement to this effect must be provided by the Licensee in the immediately subsequent royalty and Sublicense Fee report.

 

11.     BOOKS AND RECORDS

 

11.1       The Licensee will keep accurate books and records showing all Licensed Product under development, manufactured, used, offered for Sale, imported, Sold and or otherwise exploited; all Licensed Service Sold or otherwise provided; all Net Sales, all Attributed Income, all Service Income and other amounts payable hereunder; and all sublicenses granted under the terms of this Agreement. Such books and records will be preserved for at least five (5) years after the date of the payment to which they pertain and will be open to examination by representatives

 

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or agents of The Regents during regular office hours to determine their accuracy and assess the Licensee’s compliance with the terms of this Agreement.

 

11.2       The Regents shall pay the fees and expenses of such examination.  If, however, an error in royalties of more than five percent (5%) of the total royalties due for any year is discovered in any examination, then the Licensee shall bear the fees and expenses of such examination and shall remit such underpayment to The Regents within thirty (30) days of the examination results.

 

12.     LIFE OF THE AGREEMENT

 

12.1       Unless otherwise terminated by operation of law, Paragraph 12.2, or by acts of the parties in accordance with the terms of this Agreement, this Agreement will remain in effect from the Effective Date until the expiration or abandonment of the last of the Patent Rights licensed hereunder.

 

12.2       This Agreement will automatically terminate without the obligation to provide 60 days’ notice as set forth in Article 13 (Termination By The Regents) upon the filing of a petition for relief under the United States Bankruptcy Code by or against the Licensee as a debtor or alleged debtor, provided that if such petition is filed against Licensee, this Agreement will be reinstated (wherein the effective date of reinstatement shall be the date of automatic termination) under this Article 12.2 if such petition is withdrawn or dismissed within ninety (90) days of such filing.  Further, (a) during such 90-day period, The Regents will not grant a license to any third party that could preclude full reinstatement of Licensee’s rights and licenses hereunder, and (b) The Regents will not assert Patent Rights against Licensee resulting from Licensee’s use of the Licensed Product and Licensed Method during such ninety (90) day period, except, in the event of reinstatement, The Regents may pursue a claim for earned royalties and/or minimum annual royalties and/or milestone payments that would have otherwise been due during such 90-day period.

 

12.3       Any termination or expiration of this Agreement will not affect the rights and obligations set forth in the following Articles:

 

	
Article 1
    	
Definitions
    
	
Paragraph   4.7
    	
Late   Payments
    
	
Article 5
    	
License   Issue Fee
    

 

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Article 6
    	
Payments   on Sublicenses (only to the extent payments to The Regents are owed on   activities performed prior to termination or expiration or under Article 15)
    
	
Paragraphs   7.1 and 7.2
    	
Earned   Royalties and Minimum Annual Royalties (only to the extent payments to The   Regents are owed on activities performed prior to termination or expiration   or under Article 15)
    
	
Article 11
    	
Books   and Records
    
	
Article 12
    	
Life   of the Agreement
    
	
Article 15
    	
Disposition   of Licensed Products and Licensed Services on Hand Upon Termination or   Expiration
    
	
Article 16
    	
Use   of Names and Trademarks
    
	
Article 17
    	
Limited   Warranty
    
	
Article 18
    	
Limitation   of Liability
    
	
 
    	
 
    
	
Article 22
    	
Indemnification
    
	
Article 23
    	
Notices
    
	
Article 27
    	
Governing   Laws; Venue; Attorneys Fees
    
	
Article 30
    	
Confidentiality
    

 

12.4       The termination or expiration of this Agreement will not relieve the Licensee of its obligation to pay any fees, royalties or other payments owed to The Regents at the time of such termination or expiration and will not impair any accrued right of The Regents, including the right to receive Earned Royalties in accordance with Articles 6 (Payments on Sublicenses), 7 (Earned Royalties and Minimum Annual Royalties) (with respect to activities prior to such termination or expiration) and 15 (Disposition of Licensed Products and Licensed Services Upon Termination or Expiration).

 

13.     TERMINATION BY THE REGENTS

 

If the Licensee fails to perform or violates any term of this Agreement, then The Regents may give written notice of such default (“Notice of Default”) to the Licensee.  If the Licensee fails to repair such default within sixty (60) days after the effective date of such notice, then The Regents will have the right to immediately terminate this Agreement and its licenses by providing a written notice of termination (“Notice of Termination”) to the Licensee.  If the Licensee, in good faith, is not able to repair the default within sixty (60) days, the Licensee may discuss with and explain to The Regents such inability and Licensee’s proposed eventual resolution of the default within sixty (60) days of the effective date of the Notice of Default.  If

 

22

 

The Regents is not satisfied with that explanation, then The Regents may terminate.  However, if Licensee disputes the breach by demanding arbitration before the AAA or by filing a law suit within the cure period, then The Regents shall not have the right to terminate this Agreement unless it has been determined by an arbitrator or court proceeding that this Agreement was materially breached and if Licensee fails to comply with its obligations hereunder within sixty (60) days after that determination; provided that all costs and legal expenses, including but not limited to attorney’s fees, for such arbitration or court proceeding shall be reimbursed to the prevailing party by the other party.

 

14.     TERMINATION BY LICENSEE

 

The Licensee has the right at any time to terminate this Agreement by providing a Notice of Termination to The Regents.  Moreover, the Licensee will be entitled to terminate the rights under Patent Rights on a country-by-country basis by giving notice in writing to The Regents. Termination of this Agreement (but not termination of any patents or patent applications under Patent Rights, which termination is subject to Paragraph 19.3 and 19.6) will be effective sixty (60) days from the effective date of such notice.

 

15.     DISPOSITION OF LICENSED PRODUCT AND LICENSED SERVICES UPON TERMINATION OR EXPIRATION

 

15.1       Upon termination (but not expiration) of this Agreement, within a period of one hundred and twenty (120) days after the date of termination, the Licensee is entitled to (i) dispose of all previously made or partially made Licensed Product, but no more and (ii) provide previously contracted-for Licensed Services, provided that the Sale or use of such Licensed Product and the provision of such Licensed Services are subject to the terms of this Agreement, including, but not limited to, the rendering of reports and payment of Earned Royalties, Sublicense Fees and any other payments therefor required under this Agreement.  The Licensee will not otherwise make, use, Sell, offer for Sale or import Licensed Products or Licensed Services, or practice the Licensed Method after the date of termination unless Licensee wouldn’t be infringing The Regents’ Patent Rights in order to continue to make, use, Sell, offer for Sale or

 

23

 

import such Licensed Products or such Licensed Services, or practice such Licensed Method after the date of termination.

 

15.2       If applicable Patent Rights exist at the time of any making, Sale, offer for Sale, or import of a Licensed Product or the time of any Sale, offer for Sale, or rendering of a Licensed Service, then Earned Royalties shall be paid at the times provided herein and royalty reports shall be rendered in connection therewith, notwithstanding the absence of applicable Patent Rights with respect to such Licensed Product or Licensed Service at any later time.  Otherwise, no Earned Royalties shall be paid on the Sales of such product or service.  Any fees or other payments owed to The Regents at the time of expiration not based on the Sales of a Licensed Product or Licensed Service will be paid to The Regents at the time such fee or other payment would have been due had this Agreement not expired.

 

16.     USE OF NAMES AND TRADEMARKS

 

Nothing contained in this Agreement will be construed as conferring any right to either party to use in advertising, publicity or other promotional activities any name, trade name, trademark or other designation of the other party (including a contraction, abbreviation or simulation of any of the foregoing).  Without the Licensee’s consent case-by-case, The Regents may list Licensee’s name as a licensee of technology from The Regents without further identifying the technology.  Unless required by law or unless consented to in writing by Director, Office of Technology Management of The Regents, the use by the Licensee of the name “The Regents of the University of California” or the name of any campus of the University of California in advertising, publicity or other promotional activities is expressly prohibited.

 

17.     LIMITED WARRANTY

 

17.1       The Regents warrants to the Licensee that it has the lawful right to grant this license.

 

17.2       Except as expressly set forth in this Agreement, this license and the associated Invention, Patent Rights, Licensed Products, Licensed Services, and Licensed Methods are provided by The Regents WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED.  THE REGENTS MAKES NO EXPRESS OR IMPLIED

 

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REPRESENTATION OR WARRANTY THAT THE INVENTION, PATENT RIGHTS, LICENSED PRODUCTS, LICENSED SERVICES, OR LICENSED METHODS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHTS.

 

17.3       This Agreement does not:

 

17.3.1      express or imply a warranty or representation as to the validity, enforceability, or scope of any Patent Rights; or

 

17.3.2      express or imply a warranty or representation that anything made, used, Sold, offered for Sale or imported or otherwise exploited under any license granted in this Agreement is or will be free from infringement of patents, copyrights, or other rights of third parties; or

 

17.3.3      obligate The Regents to bring or prosecute actions or suits against third parties for patent infringement except as provided in Article 21 (Patent Infringement); or

 

17.3.4      confer by implication, estoppel or otherwise any license or rights under any patents or other rights of The Regents other than Patent Rights, regardless of whether such patents are dominant or subordinate to Patent Rights; or

 

17.3.5      obligate The Regents to furnish any New Developments, know-how, technology or information not provided in Patent Rights.

 

18.     LIMITATION OF LIABILITY

 

THE REGENTS WILL NOT BE LIABLE FOR ANY LOST PROFITS, COSTS OF PROCURING SUBSTITUTE GOODS OR SERVICES, LOST BUSINESS, ENHANCED DAMAGES FOR INTELLECTUAL PROPERTY INFRINGEMENT OR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR OTHER SPECIAL DAMAGES SUFFERED BY LICENSEE, SUBLICENSEES, JOINT VENTURES, OR AFFILIATES ARISING OUT OF OR RELATED TO THIS AGREEMENT FOR ALL CAUSES OF ACTION OF ANY KIND (INCLUDING TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY AND BREACH OF WARRANTY) EVEN IF THE REGENTS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

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19.     PATENT PROSECUTION AND MAINTENANCE

 

19.1       In the event that Patent Rights are jointly owned by The Regents and the Licensee (“Joint Parties”), then the Licensee will diligently prosecute and maintain such U.S. and foreign patents and patent applications using counsel chosen by the Licensee. The Licensee will provide copies of all relevant documentation so that The Regents will be informed of the continuing prosecution and may comment upon such documentation sufficiently in advance of any initial deadline for filing a response, provided, however, that if The Regents has not commented upon such documentation in a reasonable time for the Licensee to sufficiently consider The Regents’ comments prior to a deadline with the relevant government patent office, or the Licensee must act to preserve the Patent Rights, the Licensee will be free to respond without consideration of The Regents’ comments, if any.  The Regents agrees to keep this documentation confidential as provided for in Article 30 (Confidentiality).

 

19.2       The Licensee shall use reasonable efforts to amend any patent application to include claims reasonably requested by The Regents.

 

19.3       All patents and patent applications under this Article 19 shall be assigned to Licensee and The Regents, and any other owner by operation of inventorship and obligations of assignment under relevant U.S. and state law.  If Licensee elects not to continue patent prosecution of Patent Rights, jointly owned by Licensee and The Regents, including claims within a case as well as non-elected species, then The Regents shall have the sole right to continue the prosecution and/or maintenance of such application(s) or patent(s) at its sole discretion and expense and Licensee will have no further right or licenses to The Regents’ undivided interest thereunder.  Licensee shall not make such election less than [***] prior to the deadline for any payment, filing, or action to be taken in connection with such Patent Rights.

 

19.4       The Licensee will apply for an extension of the term of any patent included within the Patent Rights if appropriate under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or European, Japanese and other foreign counterparts of this Law.  Notwithstanding the foregoing, if a particular Licensed Product is covered by multiple patents owned or controlled by Licensee, Licensee shall have the right to use its commercially reasonable judgment in selecting which patent to seek to extend and shall provide The Regents with its analysis and decision in writing.  The Licensee shall prepare all documents and The Regents

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

26

 

agrees to execute the documents and to take additional action as the Licensee reasonably requests in connection therewith.  Licensee shall be liable for [***] costs relating to such application.

 

19.5       If either party (in the case of The Regents, the Licensing Officer responsible for administration of this Agreement) receives notice pertaining to the infringement or potential infringement of any issued patent included within the Patent Rights under the Drug Price Competition and Patent Term Restoration Act of 1984 (and/or foreign counterparts of this Law), then that party shall notify the other party within ten (10) days after receipt of notice of infringement.

 

19.6       The Licensee will bear the costs of preparing, filing, prosecuting and maintaining all United States and foreign patent applications contemplated by this Agreement (“Patent Prosecution Costs”).  Patent Prosecution Costs shall include the cost of having The Regents’ counsel review and comment on the prosecution of Patent Rights, but not those costs associated with patent infringement described in Article 21 (Patent Infringement) or other litigation associated costs.  Licensee shall not be responsible for reimbursing The Regents’ Patent Prosecution Costs in excess of [***] and associated foreign applications with claims entirely within the scope of the associated US patent application (“Patent Family”).  For the avoidance of doubt, any foreign applications containing claims outside the scope of a putatively associated US application shall have a separate Patent Prosecution Costs reimbursement budget.  For the additional avoidance of doubt, each divisional, continuation, and continuation-in-part application will have a separate Patent Prosecution Costs reimbursement budget of [***]. Patent Prosecution Costs billed by The Regents’ counsel will be rebilled to the Licensee and are due within thirty (30) days of rebilling by The Regents.

 

19.7       The Licensee will be obligated to pay any Patent Prosecution Costs incurred during the three (3)-month period after receipt by either party of a Notice of Termination, even if the invoices for such Patent Prosecution Costs are received by the Licensee after the end of the three (3)-month period following receipt of a Notice of Termination.  The Licensee may terminate its obligation to pay Patent Prosecution Costs with respect to any given patent application or patent under Patent Rights in any or all designated countries upon three (3)-months’ written notice to The Regents. The Regents may continue prosecution and/or maintenance of such application(s)

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

27

 

or patent(s) at its sole discretion and expense, provided, however, that the Licensee will have no further right or licenses thereunder.

 

20.     PATENT MARKING

 

The Licensee will mark all Licensed Products made, used or Sold under the terms of this Agreement or their containers in accordance with the applicable patent marking laws.

 

21.     PATENT INFRINGEMENT

 

21.1       In the event that The Regents (to the extent of the actual knowledge of the licensing professional responsible for the administration of this Agreement) or the Licensee learns of infringement of potential commercial significance of any patent licensed under this Agreement, the knowledgeable party will provide the other (i) with written notice of such infringement and (ii) with any evidence of such infringement available to it (the “Infringement Notice”).  During the period in which, and in the jurisdiction where, the Licensee has exclusive rights under this Agreement, neither The Regents nor the Licensee will notify a possible infringer of infringement or put such infringer on notice of the existence of any Patent Rights without first obtaining consent of the other.  If the Licensee puts such infringer on notice of the existence of any Patent Rights with respect to such infringement without first obtaining the written consent of The Regents and if a declaratory judgment action is filed by such infringer against The Regents, then Licensee’s right to initiate a suit against such infringer for infringement under Paragraph 21.2 below will terminate immediately without the obligation of The Regents to provide notice to the Licensee.   Both The Regents and the Licensee will use their diligent efforts to cooperate with each other to terminate such infringement without litigation.

 

21.2       If infringing activity of potential commercial significance by the infringer has not been abated within ninety (90) days following the date the Infringement Notice takes effect, then the Licensee may institute suit for patent infringement against the infringer (itself and/or through a designee).  The Regents may voluntarily join such suit at its own expense, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of the Licensee’s suit or any judgment rendered in that suit.  The Licensee may not join The Regents in a suit initiated by the Licensee without The Regents’ prior written consent.  If, in a suit initiated

 

28

 

by the Licensee, The Regents is involuntarily joined other than by the Licensee, then the Licensee will pay [***] costs incurred by The Regents arising out of such suit, including but not limited to, [***] legal fees of counsel that The Regents selects and retains to represent it in the suit.

 

21.3                      If, within a hundred and eighty (180) days following the date the Infringement Notice takes effect,, infringing activity of potential commercial significance by the infringer has not been abated and if the Licensee has not brought suit against the infringer, then The Regents may institute suit for patent infringement against the infringer.  If The Regents institutes such suit, then the Licensee may not join such suit without The Regents’ consent and may not thereafter commence suit against the infringer for the acts of infringement that are the subject of The Regents’ suit or any judgment rendered in that suit.

 

21.4                      Notwithstanding anything to the contrary in this Agreement, in the event that the infringement or potential infringement pertains to an issued patent included within the Patent Rights and written notice is given under the Drug Price Competition and Patent Term Restoration Act of 1984 (and/or foreign counterparts of this Law), then the party in receipt of such notice under the Act (in the case of The Regents to the extent of the actual knowledge of the licensing officer responsible for the administration of this Agreement) shall provide the Infringement Notice to the other party promptly.  If the time period is such that the Licensee will lose the right to pursue legal remedy for infringement by not notifying a third party or by not filing suit, the notification period and the time period to file suit will be accelerated to within forty-five (45) days of the date of such notice under the Act to either party.

 

21.5                      Any recovery or settlement received in connection with any suit will first be shared by The Regents and the Licensee equally to cover any litigation costs each incurred and next shall be paid to The Regents or the Licensee to cover any litigation costs it incurred in excess of the litigation costs of the other.  In any suit, any recovery in excess of litigation costs will be shared between Licensee and The Regents as follows: (a) for any recovery other than amounts paid for willful infringement: (i) the party initiating and leading the suit will receive [***] of the recovery and the other party will receive [***] of the recovery; and (b) for any recovery for willful infringement, each party will receive [***] of the recovery.  The Regents and the Licensee agree to be bound by all determinations of patent infringement, validity and enforceability (but no

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

29

 

other issue) resolved by any adjudicated judgment in a suit brought in compliance with this Article 21 (Patent Infringement).

 

21.6                      Any agreement made by the Licensee for purposes of settling litigation or other dispute shall comply with the requirements of Article 3 (Sublicenses) of this Agreement.

 

21.7                      Each party will cooperate with the other in litigation proceedings instituted hereunder but at the expense of the party who initiated the suit (unless such suit is being jointly prosecuted by the parties).

 

21.8                      Any litigation proceedings will be controlled by the party bringing the suit, except that The Regents may be represented by counsel of its choice in any suit brought by the Licensee.

 

22.              INDEMNIFICATION

 

22.1                      The Licensee will, and will require its Sublicensees to, indemnify, hold harmless and defend The Regents, the sponsors of the research that led to the Invention, and the inventors of any invention claimed in patents or patent applications under Patent Rights (including the Licensed Products, Licensed Services and Licensed Methods contemplated thereunder) and their employers, and the officers, employees and agents of any of the foregoing, against any and all claims, suits, losses, damage, costs, fees and expenses resulting from, or arising out of, the exercise of this license or any sublicense.  This indemnification will include, but not be limited to, any product liability.  If The Regents, in its sole discretion, believes that there will be a conflict of interest or it will not otherwise be adequately represented by counsel chosen by the Licensee to defend The Regents in accordance with this Paragraph 22.1, then The Regents may retain counsel of its choice to represent it and the Licensee will pay [***] expenses for such representation.

 

22.2                      During the term of this Agreement, unless the insurance below is written on a claims-made form, the Licensee, at its sole cost and expense, will insure its activities in connection with any work performed hereunder and will obtain, keep in force, and maintain the following insurance (or an equivalent program of self-insurance):

 

22.2.1                  Commercial Form General Liability Insurance (contractual liability included) with limits as follows:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

30

 

	
Each Occurrence
    	
 
    	
$
    	
5,000,000
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Products/Completed Operations Aggregate
    	
 
    	
$
    	
10,000,000
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Personal and Advertising Injury
    	
 
    	
$
    	
5,000,000
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
General Aggregate (commercial form only)
    	
 
    	
$
    	
10,000,000
    	
 
    

 

If the above insurance is written on a claims-made form, it shall continue for three (3) years following termination or expiration of this Agreement.  The insurance shall have a retroactive date of placement prior to or coinciding with the Effective Date of this Agreement; and

 

22.2.2                  Worker’s Compensation as legally required in the jurisdiction in which the Licensee is doing business.

 

22.3                      The coverage and limits referred to in Paragraph 22.2.1 and 22.2.2 above will not in any way limit the liability of the Licensee under this Article 22 (Indemnification).  Upon the execution of this Agreement, the Licensee will furnish The Regents with certificates of insurance evidencing compliance with all requirements.  Such certificates will:

 

·      Provide for thirty (30) days’ (ten (10) days for non-payment of premium) advance written notice to The Regents of any cancellation of insurance coverage; the Licensee will promptly notify The Regents of any material modification of the insurance coverage;

·      Indicate that The Regents has been endorsed as an additional insured under the coverage described above in Paragraph 22.2.1; and

·      Include a provision that the coverage will be primary and will not participate with, nor will be excess over, any valid and collectable insurance or program of self-insurance maintained by The Regents.

 

22.4                      The Regents will promptly notify the Licensee in writing of any claim or suit brought against The Regents for which The Regents intends to invoke the provisions of this Article 22 (Indemnification).  The Licensee will keep The Regents informed of its defense of any claims pursuant to this Article 22 (Indemnification).

 

23.              NOTICES

 

23.1                      Any notice or payment required to be given to either party under this Agreement will be in writing and will be deemed to have been properly given and to be effective as of the date specified below if delivered to the respective address given below or to another address as designated by written notice given to the other party:

 

23.1.1                  on the date of delivery if delivered in person;

 

31

 

23.1.2                  on the date of mailing if mailed by first-class certified mail, postage paid; or

 

23.1.3                  on the date of mailing if mailed by any global express carrier service that requires the recipient to sign the documents demonstrating the delivery of such notice or payment.

 

	
In   the case of Licensee:
    	
 
    	
Singulex   Inc.
    
	
 
    	
 
    	
1650   Harbor Bay Parkway, Suite 200
    
	
 
    	
 
    	
Alameda,   CA 94502-3012
    
	
 
    	
 
    	
Attention:   Gulshan H. Shaver
    
	
 
    	
 
    	
 
    
	
In   the case of The Regents:
    	
 
    	
The   Regents of the University of California
    
	
 
    	
 
    	
Office   of Technology Management
    
	
 
    	
 
    	
185   Berry Street, Suite 4603
    
	
 
    	
 
    	
San   Francisco, CA 94107
    
	
 
    	
 
    	
Attention:   Director
    
	
 
    	
 
    	
RE:   UC Case No. SF2008-042 and SF2009-027
    
	
 
    	
 
    	
 
    
	
Payments to The Regents should be directed to:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Office   of Technology Transfer
    
	
 
    	
 
    	
Attn:   Accounts Receivable
    
	
 
    	
 
    	
University   of California
    
	
 
    	
 
    	
Office   of the President
    
	
 
    	
 
    	
1111   Franklin Street, 7th Floor
    
	
 
    	
 
    	
Oakland,   CA 94607-5200
    
	
 
    	
 
    	
Re:   UC Case No. SF2008-042 and SF2009-027
    

 

24.              ASSIGNABILITY

 

This Agreement is personal to the Licensee.  The Licensee may not assign or transfer this Agreement, including by merger, operation of law, or otherwise, without The Regents’ prior written consent, except that such consent will not be required in the case of assignment or transfer to a party that succeeds to all or substantially all of Licensee’s business or assets relating to this Agreement, whether by sale, merger, operation of law or otherwise, provided that such assignee or transferee promptly agrees to be bound by the terms and conditions of this Agreement and signs The Regents’ standard substitution of party letter (the form of which is attached hereto as Appendix A).  Any attempted assignment by the Licensee in violation of this

 

32

 

Article 24 (Assignment) will be null and void.  This Agreement is binding upon and will inure to the benefit of The Regents, its successors and assigns.

 

25.              WAIVER

 

No waiver by either party of any breach or default of any of the agreements contained herein will be deemed a waiver as to any subsequent and/or similar breach or default.  No waiver will be valid or binding upon the parties unless made in writing and signed by a duly authorized officer of each party.

 

26.              FORCE MAJEURE

 

26.1                      Except for the Licensee’s obligation to make any payments to The Regents hereunder, the parties shall not be responsible for any failure to perform due to the occurrence of any events beyond their reasonable control which render their performance impossible or onerous, including, but not limited to:  accidents (environmental, toxic spill, etc.); acts of God; biological or nuclear incidents; casualties; earthquakes; fires; floods; governmental acts; orders or restrictions; inability to obtain suitable and sufficient labor, transportation, fuel and materials; local, national or state emergency; power failure and power outages; acts of terrorism; strike; and war.

 

26.2                      Either party to this Agreement, however, will have the right to terminate this Agreement upon thirty (30) days’ prior written notice if either party is unable to fulfill its obligations under this Agreement due to any of the causes specified in Paragraph 26.1 for a period of one (1) year.

 

27.              GOVERNING LAWS; VENUE; ATTORNEYS’ FEES

 

27.1                      THIS AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, excluding any choice of law rules that would direct the application of the laws of another jurisdiction and without regard to which party drafted particular provisions of this Agreement, but the scope and validity of any patent or patent application will be governed by the applicable laws of the country of such patent or patent application.

 

33

 

27.2                      Any legal action brought by the parties hereto relating to this Agreement will be conducted in San Francisco, California.

 

27.3                      The prevailing party in any suit related to this Agreement will be entitled to recover its reasonable attorneys’ fees in addition to its costs and necessary disbursements.

 

28.              GOVERNMENT APPROVAL OR REGISTRATION

 

If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, the Licensee will assume all legal obligations to do so.  The Licensee will notify The Regents if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. The Licensee will make all necessary filings and pay all costs including fees, penalties and all other out-of-pocket costs associated with such reporting or approval process.

 

29.              COMPLIANCE WITH LAWS

 

The Licensee shall comply with all applicable international, national, state, regional and local laws and regulations in performing its obligations hereunder and in its use, manufacture, Sale or import of the Licensed Products, Licensed Services or practice of the Licensed Method.  The Licensee will observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data and the provision of Licensed Services to foreign countries, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations.  The Licensee shall manufacture Licensed Products and practice the Licensed Method in compliance with applicable government importation laws and regulations of a particular country for Licensed Products made outside the particular country in which such Licensed Products are used, Sold or otherwise exploited.

 

30.              CONFIDENTIALITY

 

30.1                      The Licensee and The Regents will treat and maintain the other party’s proprietary business, patent prosecution, software, engineering drawings, process and technical information and other proprietary information, including the negotiated terms of this Agreement and any progress reports and royalty reports and any sublicense agreement issued pursuant to this

 

34

 

Agreement (“Proprietary Information”) in confidence using at least the same degree of care as the receiving party uses to protect its own proprietary information of a like nature from the date of disclosure until [***] after the termination or expiration of this Agreement.

 

30.2                      The Licensee and The Regents may use and disclose Proprietary Information to their employees, agents, consultants, contractors and, in the case of the Licensee, its Sublicensees, Affiliates and others on a need-to-know basis provided that such parties are bound by a like duty of confidentiality as that found in this Article 30 (Confidentiality).  Notwithstanding anything to the contrary contained in this Agreement, The Regents may release this Agreement or any sublicense, including any terms thereof, and information regarding royalty payments or other income received in connection with this Agreement to the inventors, senior administrative officials employed by The Regents and individual Regents upon their request.  If such release is made, The Regents will request that such terms be kept in confidence in accordance with the provisions of this Article 30 (Confidentiality).  In addition, notwithstanding anything to the contrary in this Agreement, if a third party inquires whether a license to Patent Rights is available, then The Regents may disclose the existence of this Agreement and the extent of the grant in Articles 2 (Grant) and 3 (Sublicenses) and related definitions to such third party, but will not disclose the name of the Licensee unless Licensee has already made such disclosure publicly.

 

30.3                      All written Proprietary Information will be labeled or marked confidential or proprietary.  If the Proprietary Information is orally disclosed, it will be reduced to writing or some other physically tangible form, marked and labeled as confidential or proprietary by the disclosing party and delivered to the receiving party within thirty (30) days after the oral disclosure.

 

30.4                      Nothing contained herein will restrict or impair, in any way, the right of the Licensee or The Regents to use or disclose any Proprietary Information:

 

30.4.1                  that recipient can demonstrate by written records was previously known to it prior to its disclosure by the disclosing party;

 

30.4.2                  that recipient can demonstrate by written records is now, or becomes in the future, public knowledge other than through acts or omissions of recipient;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

35

 

30.4.3                  that recipient can demonstrate by written records was obtained lawfully and without restrictions on the recipient from sources independent of the disclosing party; and

 

30.4.4                  that The Regents is required to disclose pursuant to the California Public Records Act or other applicable law.

 

The Licensee or The Regents also may disclose Proprietary Information that is required to be disclosed (i) to a governmental entity or agency in connection with seeking any governmental or regulatory approval, governmental audit, or other governmental contractual requirement or (ii) by law, provided that the recipient uses reasonable efforts to give the party owning the Proprietary Information sufficient notice of such required disclosure to allow the party owning the Proprietary Information reasonable opportunity to object to, and to take legal action to prevent, such disclosure.

 

30.5                      Upon termination of this Agreement, the Licensee and The Regents will destroy or return any of the disclosing party’s Proprietary Information in its possession within fifteen (15) days following the termination of this Agreement.  The Licensee and The Regents will provide each other, within thirty (30) days following termination, with written notice that such Proprietary Information has been returned or destroyed.  Each party may, however, retain one copy of such Proprietary Information for archival purposes in non-working files.

 

31.              ARBITRATION

 

31.1                      Any dispute, claim or controversy arising from or related in any way to Article 13 (Termination by The Regents) of this Agreement shall, if submitted for resolution under this Article 31, be subject to arbitration pursuant to the rules then pertaining of the American Arbitration Association (“AAA”), except where those rules conflict with these provisions, in which case these provisions control.  Notwithstanding the foregoing, the following matters shall not be subject to arbitration: claims arising under Article 16 (Use of Names and Trademarks), Article 17 (Limited Warranty), Article 18 (Limitation of Liability), Article 22 (Indemnification), and any claims of patent infringement.

 

31.2                      The panel shall consist of three arbitrators chosen from the California AAA (or, by agreement, from another provider of arbitrators) each of whom is a lawyer with at least 15 years

 

36

 

experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction.  In the event the aggregate damages sought by the claimant are stated to be less than $5 million, and the aggregate damages sought by the counterclaimant are stated to be less than $5 million, and neither side seeks equitable relief, then a single arbitrator shall be chosen, having the same qualifications and experience specified above.  Each arbitrator shall be neutral, independent, disinterested, impartial and shall abide by the Commercial Arbitration Rules of the AAA.  Arbitration shall be held at the location of the Party not seeking arbitration.

 

31.3                      The parties agree to cooperate (1) to attempt to select the arbitrator(s) by agreement within 45 days of initiation of the arbitration, including jointly interviewing the final candidates if feasible, (2) to meet with the arbitrator(s) within 45 days of selection and (3) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which will result in the hearing being concluded within no more than nine (9) months after selection of the arbitrator(s) and in the award being rendered within 60 days of the conclusion of the hearings, or of any post-hearing briefing, which briefing will be completed by both sides within 45 days after the conclusion of the hearings.

 

31.4                      In the event the parties cannot agree upon selection of the arbitrator(s), the AAA will select arbitrator(s) as follows: AAA shall provide the parties with a list of no less than 25 proposed arbitrators from among the California AAA commercial arbitration panelists (15 if a single arbitrator is to be selected) having the credentials referenced above.  Within 25 days of receiving such list, the parties shall rank at least 65% of the proposed arbitrators on the initial AAA list, after exercising cause challenges.  The parties may then interview the five candidates (three if a single arbitrator is to be selected) with the highest combined rankings for no more than one hour each and, following the interviews, may exercise one peremptory challenge each.  The panel will consist of the remaining three candidates (or one, if one arbitrator is to be selected) with the highest combined rankings.  In the event these procedures fail to result in selection of the required number of arbitrators, AAA shall appoint the required number of arbitrators from among the California AAA commercial arbitration panelists allowing each side challenges for cause and three peremptory challenges each

 

37

 

31.5                      In the event the parties cannot agree upon procedures for discovery and conduct of the hearing meeting the schedule set forth in Article 31.3 above, then the arbitrator(s) shall set dates for the hearing, any post-hearing briefing, and the issuance of the award in accord with the Article 31.3 schedule.  The arbitrator(s) shall provide for discovery according to those time limits, giving recognition to the understanding of the parties that they contemplate reasonable discovery, including document demands and depositions, but that such discovery be limited so that the Article 31.3 schedule may be met without difficulty. In no event will the arbitrator(s), absent agreement of the parties, allow more than a total of ten days for the hearing or permit either side to obtain more than a total of 40 hours of deposition testimony from all witnesses, including both fact and expert witnesses, or serve more than 20 individual requests for documents, including subparts, or 20 individual requests for admission or interrogatories, including subparts.  Multiple hearing days will be scheduled consecutively to the greatest extent possible.

 

31.6                      The arbitrator(s) must render their award by application of the substantive law of California and are not free to apply “amiable compositeur” or “natural justice and equity.”  The arbitrator(s) shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefore stated.  A transcript of the evidence adduced at the hearing shall be made and shall, upon request, be made available to either party.  The arbitrator(s) shall have power to exclude evidence on grounds of hearsay, prejudice beyond its probative value, redundancy, or irrelevance and no award shall be overturned by reason of such ruling on evidence.

 

31.7                      In the event the panel’s award exceeds $5 million in monetary damages or includes or consists of equitable relief, or rejects a claim in excess of that amount or for that relief, then the losing party may obtain review of the arbitrators’ award or decision by a single appellate arbitrator (the “Appeal Arbitrator”) selected from the California AAA commercial arbitration panelists and pursuant to selection procedures specified in paragraph 31.4 above.  If AAA cannot provide such services, the parties will together select another provider of arbitration services that can.  No Appeal Arbitrator shall be selected unless he or she can commit to rendering a decision within ninety days following oral argument as provided in this paragraph.  Any such review must

 

38

 

be initiated within thirty (30) days following the rendering of the award referenced in 31.6 above.

 

31.8                      The Appeal Arbitrator will make the same review of the arbitration panel’s ruling and its bases that the U.S. Court of Appeals of the Circuit where the arbitration hearings are held would make of findings of fact and conclusions of law rendered by a district court after a bench trial and then modify, vacate or affirm the arbitration panel’s award or decision accordingly, or remand to the panel for further proceedings.  The Appeal Arbitrator will consider only the arbitration panel’s findings of fact and conclusions of law, pertinent portions of the hearing transcript and evidentiary record as submitted by the parties, opening and reply briefs of the party pursuing the review, and the answering brief of the opposing party, plus a total of no more than four (4) hours of oral argument evenly divided between the parties.  The party seeking review must submit its opening brief and any reply brief within seventy-five (75) and one hundred thirty (130) days, respectively, following the date of the award under review, whereas the opposing party must submit its responsive brief within one hundred ten (110) days of that date.  Oral argument shall take place within five (5) months after the date of the award under review, and the Appeal Arbitrator shall render a decision within forty-five (45) days following oral argument.  That decision will be final and not subject to further review, except pursuant to the Federal Arbitration Act.

 

31.9                      Each party has the right before or, if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.

 

32.            MISCELLANEOUS

 

32.1                      The headings of the several articles are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

 

32.2                      This Agreement is not binding on the parties until it has been signed below on behalf of each party.  It is then effective as of the Effective Date.

 

32.3                      No amendment or modification of this Agreement is valid or binding on the parties unless made in writing and signed on behalf of each party.

 

39

 

32.4                      This Agreement embodies the entire understanding of the parties and supersedes all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof.

 

32.5                      In case any of the provisions contained in this Agreement is held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect any other provisions of this Agreement and this Agreement will be construed as if such invalid, illegal or unenforceable provisions had never been contained in it.

 

32.6                      No provisions of this Agreement are intended or shall be construed to confer upon or give to any person or entity other than The Regents and the Licensee any rights, remedies or other benefits under, or by reason of, this Agreement.

 

32.7                      In performing their respective duties under this Agreement, each of the parties will be operating as an independent contractor.  Nothing contained herein will in any way constitute any association, partnership, or joint venture between the parties hereto, or be construed to evidence the intention of the parties to establish any such relationship.  Neither party will have the power to bind the other party or incur obligations on the other party’s behalf without the other party’s prior written consent.

 

IN WITNESS WHEREOF, both The Regents and the Licensee have executed this Agreement, in duplicate originals, by their respective and duly authorized officers on the day and year written.

 

 

	
SINGULEX, INC.
    	
THE   REGENTS OF THE UNIVERSITY OF CALIFORNIA
    
	
 
    	
 
    
	
 
    	
 
    
	
By: 
    	
/s/ Philippe Goix
    	
 
    	
By:
    	
/s/ Joel B. Kirschbaum Ph.D.
    
	
 
    	
(Signature)
    	
 
    	
 
    	
(Signature)
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Philippe Goix
    	
 
    	
Name:
    	
Joel   B. Kirschbaum Ph.D.
    
	
 
    	
President and CEO
    	
 
    	
 
    	
Director,   UCSF OTM
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date: 
    	
2/9/09
    	
 
    	
Date:
    	
3/13/09
    

 

40

 

APPENDIX A

 

CONSENT TO SUBSITUTION OF PARTY

 

This substitution of parties (“Agreement”) is effective this             day of                    , 2008 among The Regents of the University of California (“The Regents”), a California corporation, having its statewide administrative offices at 1111 Franklin Street, 12th Floor, Oakland, California 94607-5200 acting through its Office of Technology Management, University of California San Francisco, 185 Berry Street, Suite 4603, San Francisco, California 94107 (“UCSF”), Singulex, Inc., a Delaware corporation, having a principal place of business at 1650 Harbor Bay Parkway, Suite 200, Alameda, California 94502 (“Singulex”); and [new licensee name] [(“YYY”)] a                                              corporation, having a principal place of business at                             .

 

BACKGROUND

 

A.                                   The Regents and Singulex entered into a License Agreement effective         (UC Control No.    -     -        ), entitled Exclusive license for HIGHLY SENSITIVE SYSTEM AND METHODS FOR ANALYSIS OF TROPONIN (“License Agreement”), wherein Singulex was granted certain rights.

 

B.             Singulex desires that [YYY] be substituted as [Licensee] (defined in the License Agreement) in place of Singulex, and The Regents is agreeable to such substitution.

 

C.             [YYY] has read the License Agreement and agrees to abide by its terms and conditions.

 

The parties agree as follows:

 

1.               [YYY] assumes all liability and obligations under the License Agreement and is bound by all its terms in all respects as if it were the original [Licensee] of the License Agreement in place of Singulex.

 

41

 

2.               [YYY] is substituted for Singulex, provided that [YYY] assumes all liability and obligations under the License Agreement as if [YYY] were the original party named as [Licensee] as of the effective date of the License Agreement.

 

3.               The Regents releases Singulex from all liability and obligations under the License Agreement arising before or after the effective date of this Agreement.

 

4.               The parties have executed this Agreement in triplicate originals by their respective authorized officers on the following day and year.

 

 

	
SINGULEX, INC.
    	
THE   REGENTS OF THE
    
	
 
    	
 
    
	
 
    	
UNIVERSITY   OF CALIFORNIA
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
 
    	
By:
    	
 
    
	
 
    	
(Signature)
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
Name:
    	
Joel   B. Kirschbaum
    
	
 
    	
(Please print)
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    	
Title:
    	
Director
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Office   of Technology Management
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
 
    	
 
    	
Date:
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
[YYY] COMPANY
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
 
    	
 
    	
 
    
	
 
    	
(Signature)
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
 
    
	
 
    	
(Please print)
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
 
    	
 
    	
 
    

 

42Exhibit 10.8

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

SUPPLY and LICENSE AGREEMENT

 

This Supply and License Agreement (the “AGREEMENT”) is by and between MOLECULAR PROBES, INC. (“MPI”), an Oregon corporation, with a principal business address at 29851 Willow Creek Road, Eugene, Oregon 97402, INVITROGEN IP HOLDINGS, INC., a Delaware corporation with offices at 1600 Faraday Avenue, Carlsbad, California 92008 (“IIPH”), and SINGULEX, INC. (“SINGULEX”), a Delaware corporation, with a principal business address at 4041 Forest Park Avenue, St. Louis, Missouri 63108, and is effective as of June 12, 2006 (the “EFFECTIVE DATE”).

 

ARTICLE 1. BACKGROUND RECITALS

 

1.1                                 MPI is experienced in the manufacture and supply of fluorescent dyes.

 

1.2                                 MPI and IIPH are AFFILIATES (as defined below) of Invitrogen Corporation.

 

1.3                                 IIPH has acquired rights to license the intellectual property owned by MPI related to the use or sale of fluorescent dyes and their conjugates in kits and for services.

 

1.4                                 SINGULEX is experienced in the development of kits and services.

 

1.5                                 SINGULEX wishes to obtain from MPI certain materials that are fluorescent dyes, and wishes to obtain a license from IIPH to use such materials and related intellectual property to develop products for sale in SINGULEX kits and use in SINGULEX services.

 

1.6                                 MPI is willing to provide SINGULEX’s requirements for such materials and IIPH is willing to license such use, under the terms and conditions defined herein.

 

1.7                                 Capitalized words and phrases are defined, for purposes of this AGREEMENT, where they first appear or as set forth in Article 2.

 

1.8                                 MPI, IIPH, and SINGULEX (each a “Party”, jointly the “Parties”), in consideration of the premises and of the mutual covenants and agreements contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, agree to the terms and conditions herein.

 

ARTICLE 2. DEFINITIONS

 

For purposes of this AGREEMENT, the following definitions shall apply:

 

2.1                                 “ADDITIONAL FIELDS OF USE” means each of the fields of [***], where such fields are defined as follows.  [***].  All references to “FIELD OF USE” in this AGREEMENT will be deemed to include these ADDITIONAL FIELD(S) OF USE after SINGULEX’s exercise of its respective options under paragraph 3.2.

 

1

 

2.2                                 “AFFILIATE” means with respect to a referenced entity, any entity that CONTROLS, is CONTROLLED by, or is under common CONTROL with the referenced entity, but only so long as such CONTROL exists.

 

2.3                                 “AUTHORIZED IIPH AFFILIATE” means an AFFILIATE of IIPH, including MPI, which is specifically authorized to supply MPI PRODUCTS to SINGULEX for incorporation into products, contract research services and other commercial purposes agreed hereunder.  The AUTHORIZED IIPH AFFILIATES under this AGREEMENT as of the EFFECTIVE DATE are listed in Exhibit A (AUTHORIZED IIPH AFFILIATES), which may be unilaterally updated by notification in accordance with paragraph 4.1.

 

2.4                                 “BLOCKING THIRD PARTY INTELLECTUAL PROPERTY” means, with respect to any country in the TERRITORY, patents or patent applications in such country owned or otherwise enforceable by a THIRD PARTY that cover specific reagents, assays and/or platform or any other technology required for use or sale of a SINGULEX CONJUGATE or SINGULEX KIT, if the manufacture, use or sale of such SINGULEX CONJUGATE or SINGULEX KIT would, in the absence of a license granted by such THIRD PARTY, infringe such patents or patent applications.

 

2.5                                 “CONFIDENTIAL INFORMATION” of a Party means any commercial or technical data, documents, materials, procedures, and similar information of such Party that is not generally known to the public and is maintained in a confidential manner by such Party, and that is disclosed by such Party under this AGREEMENT, whether in oral or tangible form, or is observed at such Party’s facilities during the term of this AGREEMENT.

 

2.6                                 “CONTROL” means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting securities, by contract, or otherwise.

 

2.7                                 “DEDUCTIONS” means, in relation to the sale to an END-USER or DISTRIBUTOR of any SINGULEX KIT or performance of any SINGULEX SERVICE hereunder, (i) discounts allowed and taken, in amounts customary in the trade, (ii) sales, value added, and/or use taxes and/or duties and tariffs stated on the invoice, (iii) credits or allowances for returns, if actually granted, (iv) freight and insurance and packaging costs; if such are separately invoiced to the customer, and (v) THIRD PARTY ROYALTY DEDUCTION, where applicable.

 

2.8                                 “DISTRIBUTOR” means a THIRD PARTY that, pursuant to a written agreement between such THIRD PARTY and SINGULEX regarding commercialization of SINGULEX’s full reagent product line or any portion thereof for sale to a particular market segment, resells SINGULEX KITS to END-USERS as set forth in paragraph 3.3 c), where such SINGULEX KITS are resold as packaged and sold by SINGULEX hereunder, and subject to the use limitations of this AGREEMENT, and such THIRD PARTY has agreed in writing that it will not i) repackage, derivatize, or modify such SINGULEX KITS quantitatively or qualitatively, ii) incorporate such SINGULEX KITS into any other commercial offerings, or iii) separate such SINGULEX KITS into individual components to sell or otherwise commercialize separately from such

 

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SINGULEX KITS, if the sale or use of such component utilizes IIPH LICENSE RIGHTS.

 

2.9                                 “EFFECTIVE DATE” is defined in the preamble of the AGREEMENT.

 

2.10                           “END-USER” means the ultimate purchaser of a SINGULEX KIT, whose use consumes or destroys the commercial utility of such SINGULEX KIT, or after which use any remaining SINGULEX KIT is discarded.

 

2.11                           “FIELD OF USE” means the use by END-USERS of SINGULEX KITS in combination with SINGULEX’s digital molecule counting system for a) the Initial FIELD OF USE that is (i) life science research, including clinical research and research services, and (ii) human diagnostics, and (b) the ADDITIONAL FIELD(S), if any, for those MPI PRODUCTS for which SINGULEX has exercised its option(s) pursuant to 3.2 b) with respect to such MPI PRODUCT(S) and ADDITIONAL FIELD(S).

 

2.12                           “IIPH LICENSE RIGHTS” means the intellectual property rights licensed to or owned by IIPH that relate to the manufacture, use, sale, or import of MPI PRODUCTS, or derivatives or combinations thereof, including but not limited to one or more of i) the US patents and patent applications listed in Exhibit E (IIPH LICENSE RIGHTS), and all patents issuing from said patents and patent applications, including any divisionals, continuations and continuations-in-part (to the extent that they cover the same subject matter of the original application), and reissues and reexaminations of any such patents, together with all non-US counterparts of the foregoing; and ii) know-how and trade secrets not generally available to the public but transferred to SINGULEX under this AGREEMENT; and iii) trademarks listed in Exhibit E (IIPH LICENSE RIGHTS), whether or not such trademarks are registered with the United States Patent and Trademark Office or other governmental body; and iv) copyrights as described in paragraph 10.8 (technical publications), whether or not such copyrights are registered with the US Library of Congress or other governmental body.

 

2.13                           “MPI PRODUCT” means a fluorescent dye that is commercialized by MPI under the trademark Alexa Fluor®, that has been selected by SINGULEX for commercialization under the terms of this AGREEMENT in conjunction with the license granted hereunder, and that is supplied to SINGULEX by MPI or an AUTHORIZED IIPH AFFILIATE under the terms of this AGREEMENT, where a description of each such fluorescent compound that is available to SINGULEX for commercialization under this AGREEMENT is set forth in Exhibit B (MPI PRODUCTS), and where the manufacture, use, sale, or import of such fluorescent compound, and/or conjugates/combinations thereof, is subject to one or more patents and/or patent applications included in IIPH LICENSE RIGHTS.

 

2.14                           “NET SALES” means, except as otherwise specified in this paragraph 2.14, the gross amount invoiced by SINGULEX and its AFFILIATES for the sale of SINGULEX KITS to END-USERS during the relevant time period, less applicable DEDUCTIONS.  No allowance or deduction shall be made for commissions or fees for collection, by whatever name known.

 

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Reasonable quantities of SINGULEX KITS supplied as free samples shall not be included in NET SALES in any given YEAR, so long as such quantities do not exceed [***] of SINGULEX’s total NET SALES in that same YEAR.  Reasonable quantities of SINGULEX KITS used internally for purposes of product development and research, product testing, quality control, sales demonstrations and other internal, non- revenue generating uses shall not be included in NET SALES.

 

For the avoidance of any doubt, SINGULEX will only pay royalties on the NET SALES by SINGULEX to any END-USER or DISTRIBUTOR, regardless of whether any DISTRIBUTOR subsequently resells any MPI PRODUCT on its own terms and conditions.  Neither MPI nor IIPH may charge or collect royalties from any of SINGULEX’s DISTRIBUTORS with respect to the sale or distribution of MPI PRODUCTS which are the subject of NET SALES hereunder.

 

a) Where the SINGULEX CONJUGATE or SINGULEX KIT is used by SINGULEX to perform a SINGULEX SERVICE for a THIRD PARTY, such that the SINGULEX SERVICE does not result in the transfer of a SINGULEX CONJUGATE or SINGULEX KIT to the THIRD PARTY, but only results in transfer of information to the THIRD PARTY, NET SALES is the gross amount invoiced by SINGULEX and its AFFILIATES for the sale of SINGULEX SERVICES, less the actual cost to SINGULEX for performing the SINGULEX SERVICE.  NET SALES for SINGULEX SERVICES do not include technology access fees and/or license fees (TECHNOLOGY ACCESS FEES) charged by SINGULEX for access to SINGULEX’s technology, which are calculated separately as set forth in subparagraph c), but NET SALES for SINGULEX SERVICES do include assay development fees and fees/charges for running assays for SINGULEX customers.

 

For purposes of clarification, the actual cost to SINGULEX for performing the SINGULEX SERVICE does not include the costs of any promotional activities or other costs, and consists of the cost for the personnel time and materials utilized in the performance of the SINGULEX SERVICE.  For SINGULEX KITS that are transferred to THIRD PARTIES, whether or not in combination with SINGULEX SERVICES, such SINGULEX KITS shall be separately included in NET SALES.

 

b) In the event that any performance of SINGULEX SERVICES or use, sale or transfer of SINGULEX KITS are made (i) at a preferential price between SINGULEX and any of SINGULEX’s AFFILIATES, or (ii) at a preferential price to any THIRD PARTY as a result of an understanding or arrangement unrelated to the commercialization of SINGULEX KITS (for example, but not by way of limitation, an option to take an equity interest, or a revenue-sharing arrangement), (iii) for compensation other than cash, then NET SALES for those SINGULEX SERVICES and SINGULEX KITS shall be calculated as if such SINGULEX SERVICES and SINGULEX KITS had been sold by SINGULEX for cash in an arms-length transaction, using the average gross amount invoiced for equivalent SINGULEX SERVICES and SINGULEX KITS in the applicable jurisdiction during the applicable reporting period, less any applicable DEDUCTIONS.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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c) NET SALES for TECHNOLOGY ACCESS FEES means the gross amount invoiced by SINGULEX and its AFFILIATES therefor, which, in accordance with Exhibit F, are not included in NET SALES until the YEAR 2008.

 

2.15                           “QUARTER” means one calendar quarter (a consecutive three-month period) of a YEAR.

 

2.16                           “SINGULEX CONJUGATE” means an antibody, lectin, protein, small molecule, or nucleic acid that is labeled by SINGULEX with one or more MPI PRODUCTS for incorporation into an SINGULEX KIT or use in a SINGULEX SERVICE.

 

2.17                           “SINGULEX KIT” means a compound product that contains at least:

 

a) one vial of a SINGULEX CONJUGATE that is a detection reagent,

 

b) a solid phase support assay substrate that has a binding factor attached to it (e.g., an assay plate coated with a capture reagent or a bead coated with an analyte or binding reagent),

 

c) buffers, and

 

d) a detailed protocol.

 

2.18                           “SINGULEX SERVICE” means contract research services, provided to a THIRD PARTY by SINGULEX, for developing or performing assays that utilize SINGULEX CONJUGATES or SINGULEX KITS in combination with SINGULEX’s digital molecule counting system, where such services or assays utilize IIPH LICENSE RIGHTS.  SINGULEX SERVICES include the right, under IIPH LICENSE RIGHTS, to transfer to such THIRD PARTY (or any other party) the right to use SINGULEX KITS that are supplied by or on behalf of SINGULEX and that embody such assays, in the FIELD OF USE.

 

2.19                           “TECHNOLOGY ACCESS FEE(S)” means license or access fees charged by SINGULEX for access to SINGULEX technology.

 

2.20                           “TERRITORY” means the world.

 

2.21                           “THIRD PARTY” means a person or entity that is not SINGULEX, IIPH, or MPI and is not an AFFILIATE of SINGULEX, IIPH, or MPI.

 

2.22                           “THIRD PARTY ROYALTY DEDUCTION’ means a lump sum deduction from NET SALES for any SINGULEX KIT or SINGULEX SERVICE, for royalties that are paid to THIRD PARTIES by SINGULEX for licenses under BLOCKING THIRD PARTY INTELLECTUAL PROPERTY that is employed in the manufacture, use, provision or sale of such SINGULEX KITS or SINGULEX SERVICES in the country(ies) where such BLOCKING THIRD PARTY INTELLECTUAL PROPERTY exists.  Notwithstanding the foregoing, the THIRD PARTY ROYALTY DEDUCTION explicitly excludes any portion of the royalties paid to THIRD PARTIES that is allocable to rights

 

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and licenses not necessary for SINGULEX to sell SINGULEX KITS or perform SINGULEX SERVICES, e.g. in a country where no BLOCKING THIRD PARTY INTELLECTUAL PROPERTY exists.

 

2.23                           “UNIT” means, with respect to a given MPI PRODUCT, [***] of such MPI PRODUCT.

 

2.24                           “YEAR” means calendar year.

 

ARTICLE 3. SCOPE OF AGREEMENT

 

3.1                                 This AGREEMENT sets forth the terms and conditions that govern MPI’s supply of MPI PRODUCTS, as set forth in Exhibit B (MPI PRODUCTS), and IIPH’s grant of rights regarding the incorporation thereof into SINGULEX CONJUGATES and SINGULEX KITS, and SINGULEX’s right to use such SINGULEX CONJUGATES and SINGULEX KITS in SINGULEX SERVICES, and to sell and distribute such SINGULEX KITS under IIPH LICENSE RIGHTS.  This AGREEMENT does not apply to the purchase or supply of any other materials or services, and does not apply to the grant of any other rights, other than as set forth herein.

 

3.2                                 a) IIPH hereby grants to SINGULEX, and SINGULEX hereby accepts from IIPH, an option for SINGULEX and its AFFILIATES to select any one or more MPI PRODUCTS from the list in Exhibit B (MPI PRODUCTS) for only such commercialization as is expressly authorized under this AGREEMENT, contingent on payment of the corresponding Exercise Fee set forth in Exhibit F (fees and royalties), and will apply to commercialization in SINGULEX SERVICES and in the FIELD OF USE, including any ADDITIONAL FIELDS OF USE selected pursuant to paragraph 3.2 b) below, [***], upon payment of the corresponding fees.  The foregoing option shall continue in full force and effect for the full term of this AGREEMENT.  SINGULEX shall notify IIPH of the selected MPI PRODUCTS, as set forth in paragraph 17.1 (notice requirements), and pay the corresponding fees for each MPI PRODUCT that is selected.  The Exercise Fee for the selected MPI PRODUCTS must be paid to IIPH prior to the manufacture, use, sale or other commercialization of the corresponding SINGULEX KITS or SINGULEX SERVICE.

 

b) IIPH hereby grants to SINGULEX, and SINGULEX hereby accepts from IIPH, an option for SINGULEX and its AFFILIATES to select a non-exclusive license under IIPH LICENSE RIGHTS, without right to sublicense, to commercialize SINGULEX KITS in one or more of the ADDITIONAL FIELDS OF USE to be included in the FIELD OF USE, and in the TERRITORY for the term of this AGREEMENT.  Such option must be exercised by SINGULEX, if at all, prior to the first offer for sale of SINGULEX KITS in each such ADDITIONAL FIELD OF USE.  SINGULEX shall exercise its option by notifying IIPH of its selection of the ADDITIONAL FIELD OF USE, in accordance with paragraph 17.1 (notice requirements), and paying the corresponding Exercise Fee set forth in Exhibit F (fees and royalties) for each ADDITIONAL FIELD OF USE selected by SINGULEX.  The Exercise Fees must be paid to IIPH prior to the first offer for sale by SINGULEX of the corresponding SINGULEX KITS in such ADDITIONAL FIELD OF USE.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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3.3                                 Subject to all of the terms of this AGREEMENT, and to the extent that SINGULEX has exercised one or more of the options set forth in paragraph 3.2 and paid the corresponding Exercise Fees and the one-time License Fee set forth in Exhibit F:

 

a) IIPH hereby grants to SINGULEX, and SINGULEX hereby accepts from IIPH, a non-exclusive license under IIPH LICENSE RIGHTS, without right to sublicense, for SINGULEX and its AFFILIATES to (i) use MPI PRODUCTS selected pursuant to paragraph 3.2 only to develop and make or have made SINGULEX CONJUGATES; (ii) use the SINGULEX CONJUGATES to develop SINGULEX KITS for use in the FIELD OF USE, including the ADDITIONAL FIELDS OF USE, and in the TERRITORY (including the right to use nominal amounts of MPI PRODUCTS, SINGULEX CONJUGATES and SINGULEX KITS for SINGULEX’s internal research, testing, development, and marketing of SINGULEX KITS and SINGULEX SERVICES, and other similar uses of SINGULEX KITS not related to revenue generation); (iii) to use SINGULEX CONJUGATES to make SINGULEX KITS only for use in the FIELD OF USE and in SINGULEX SERVICES in the TERRITORY; (iv) to use SINGULEX CONJUGATES and SINGULEX KITS for SINGULEX SERVICES in the TERRITORY and (v) only to the extent necessary to the exercise of rights granted in paragraph 3.3 b and c) (sell and have sold SINGULEX KITS), grant a label license to any END-USER of a SINGULEX KIT that is marked as set forth in paragraph 10.2 (marking requirements) and Exhibit G (label license) that limits the right of such END-USER to use such SINGULEX KIT in the FIELD OF USE in the TERRITORY.

 

For clarification, the grant of rights set forth above in this subparagraph 3.3 a) includes the right of SINGULEX to use SINGULEX CONJUGATES and SINGULEX KITS (using any MPI PRODUCT selected per paragraph 3.2), in the performance of SINGULEX SERVICES, to develop assays for use in the FIELD OF USE and in any of the ADDITIONAL FIELDS OF USE, regardless of whether such ADDITIONAL FIELD OF USE has been selected for any MPI PRODUCT, provided, however, that, prior to the authorized use of such assays in the ADDITIONAL FIELD OF USE, which authorized use requires the use of the corresponding SINGULEX KIT, SINGULEX shall exercise its option with respect to such FIELD OF USE.

 

Notwithstanding the foregoing, SINGULEX may use its ‘have made’ rights hereunder for the sole, limited and specific purpose of enabling a THIRD PARTY to manufacture any SINGULEX KIT on behalf of SINGULEX and to transfer such SINGULEX KITS only to SINGULEX and not to any THIRD PARTY (other than via drop shipment only on SINGULEX’s instructions).  SINGULEX will promptly notify MPI as to the identity of any such THIRD PARTY manufacturer, and SINGULEX will be liable hereunder for the acts or omissions thereof.  SINGULEX may exercise its rights to ‘have made’ a SINGULEX KIT using any MPI PRODUCT available under this AGREEMENT, regardless of whether such MPI PRODUCT has yet been selected under paragraph 3.2, provided, however, that, prior to the sale or offer for sale of any SINGULEX KIT in a FIELD OF USE, SINGULEX shall exercise its options with respect to both the respective FIELD OF USE and the respective MPI PRODUCT(S) used for such SINGULEX KIT as set forth in paragraph 3.2a.

 

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b) IIPH hereby grants to SINGULEX and SINGULEX hereby accepts from IIPH, a nonexclusive license under IIPH LICENSE RIGHTS, without rights to sublicense (except to the extent necessary to exercise the rights granted in paragraph 3.3 c) (have sold SINGULEX KITS), for SINGULEX and its AFFILIATES to import, offer for sale, and sell SINGULEX KITS only for use in the FIELD OF USE and in the TERRITORY; and to otherwise use IIPH LICENSE RIGHTS only as expressly set forth in this Article 3 (scope of agreement) and in Article 10 (proprietary rights), for purposes related to such license.

 

c) IIPH hereby grants to SINGULEX and SINGULEX hereby accepts from IIPH, a non-exclusive license under IIPH LICENSE RIGHTS, without right to sublicense, for SINGULEX and its AFFILIATES to have the SINGULEX KITS sold by DISTRIBUTORS, only for use in the FIELD OF USE and in the TERRITORY, and to otherwise use IIPH LICENSE RIGHTS as set forth in Article 10 (proprietary rights) for purposes related to such license; provided that each such DISTRIBUTOR sells such SINGULEX KITS under the label of SINGULEX.

 

3.4                                 If at any time during the term of this AGREEMENT, MPI and its AFFILIATES are unwilling or unable to supply the MPI PRODUCT and MPI and IIPH do not dispute that SINGULEX is in compliance with any provision of this AGREEMENT, as set forth in paragraph 8.4, or otherwise contend that SINGULEX has defaulted on or is in breach of this AGREEMENT, then MPI will provide, under a confidentiality agreement, its trade secret manufacturing protocols related to the MPI PRODUCTS to a THIRD PARTY manufacturer of MPI’s choosing.  Such THIRD PARTY manufacturer will be authorized to provide the MPI PRODUCTS to SINGULEX during the term of this AGREEMENT.  SINGULEX’s royalty obligations as set forth in Exhibit F (fees and royalties), would continue regardless of the source of the MPI PRODUCTS.

 

3.5                                 IIPH reserves all rights (i) for its AFFILIATES to sell any MPI PRODUCT or (ii) to license or transfer technology used to prepare any MPI PRODUCT to any other party or parties as it may, in its sole discretion, deem advisable, or not at all.

 

3.6                                 No right or license is granted to SINGULEX under this AGREEMENT to: i) manufacture or have manufactured the MPI PRODUCTS, except as provided in paragraph 3.4, or ii) incorporate or have incorporated any MPI PRODUCT or SINGULEX CONJUGATES into products other than SINGULEX KITS for sale, even if such other products would be sold for use in the FIELD OF USE or iii) transfer to any AFFILIATE or THIRD PARTY any MPI PRODUCT or SINGULEX CONJUGATE that is not incorporated into a SINGULEX KIT, even if such MPI PRODUCT or SINGULEX CONJUGATE would be transferred for use in the FIELD OF USE.

 

3.7                                 To the extent that the rights granted to SINGULEX are shared with one or more of its AFFILIATES pursuant to paragraph 3.2 (options) and 3.3 (licenses) hereunder, SINGULEX shall first impose limitations and obligations on such AFFILIATES for the benefit of IIPH and MPI, in writing, that are no less burdensome than the limitations and obligations imposed on SINGULEX hereunder.

 

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ARTICLE 4. SUPPLY TERMS

 

4.1                                 SINGULEX shall purchase its entire requirements of MPI PRODUCTS for use as set forth in Article 3 (scope of agreement) only from MPI or another AUTHORIZED IIPH AFFILIATE (jointly or separately hereinafter referred to as AUTHORIZED IIPH AFFILIATE).  Vendors that are only authorized to supply MPI’s retail products for internal research use only are not authorized to supply MPI PRODUCTS to SINGULEX for resale or commercial use.  MPI PRODUCTS will be supplied to SINGULEX according to the location in which such MPI PRODUCTS will be utilized, as set forth in Exhibit A (AUTHORIZED IIPH AFFILIATES).  MPI and IIPH shall have the option to designate one or more different AUTHORIZED IIPH AFFILIATES, of which SINGULEX will be notified in accordance with paragraph 17.1 (notice requirements).  In the event that no other AUTHORIZED IIPH AFFILIATE is able or willing to supply MPI PRODUCTS to SINGULEX, MPI shall supply MPI PRODUCTS to SINGULEX.  Each AUTHORIZED IIPH AFFILIATE hereunder shall be required to follow the procedures and requirements set forth herein with respect to the supply of MPI PRODUCTS; and SINGULEX’s obligations hereunder with respect to purchases and orders of MPI PRODUCTS shall be due likewise in equal measure to each such AUTHORIZED IIPH AFFILIATE.

 

4.2                                 At SINGULEX’s option, MPI PRODUCTS will be supplied to SINGULEX in one UNIT per vial or in bulk (multiple UNITS per vial), according to the pricing set forth in Article 7 and Exhibit C (pricing).

 

4.3                                 SINGULEX shall provide the respective AUTHORIZED IIPH AFFILIATE with non-binding six-month forecasts of SINGULEX’s needs for MPI PRODUCTS.  Such forecasts shall be used for planning purposes only, but may affect the shipment schedule as set forth in paragraph 8.1 (shipment date).

 

4.4                                 SINGULEX acknowledges that MPI PRODUCTS that are commercialized by MPI and its AFFILIATES primarily for research purposes may not be on the US Toxic Substances Control Act (TSCA) inventory.  SINGULEX is responsible for complying with the requirements necessary for MPI and its AFFILIATES to maintain its exemption from Pre- Manufacture Notification (PMN) requirements under TSCA for MPI PRODUCTS or similar regulations or government controls in other jurisdictions.  Nothing in this paragraph shall require MPI, IIPH, or its AFFILIATES to make any regulatory filings or supply any regulatory agency with any documentation other than those required for MPI and its AFFILIATES to sell MPI PRODUCTS for use as research reagents.  SINGULEX shall be solely responsible for obtaining all applicable regulatory authorizations, consents and licenses, including pre-market approvals, and SINGULEX must comply and require its AFFILIATES to comply with all governmental requirements, including but not limited to, all applicable laws, statutes, regulations, and treaties, relating to the manufacture, pre-marketing and marketing, sale, storage, shipment, and distribution of SINGULEX KITS and SINGULEX SERVICES in the TERRITORY, and relating to the performance of SINGULEX’s duties and obligations under this AGREEMENT.

 

4.5                                 SINGULEX shall not, and shall require that its AFFILIATES and DISTRIBUTORS not,

 

9

 

a) knowingly export, re-export, sell, or otherwise distribute, directly or indirectly, any MPI PRODUCTS (including MPI PRODUCTS incorporated in SINGULEX KITS) to a customer or nation to which MPI could not directly export, re-export, sell, or otherwise distribute the MPI PRODUCTS, in violation of US government regulations, including United States Export Administration Regulations, found at Title 15, Part 730 et seq. of the United States Code of Federal Regulations; or

 

b) take any action in furtherance of an unlawful order, promise, or payment to a non- United States public official, in violation of the United States Foreign Corrupt Practices Act (FCPA), nor take any action that would cause MPI or its AFFILIATES to be in violation of the FCPA.

 

Notwithstanding any other provision of this AGREEMENT, SINGULEX, IIPH, MPI, and their AFFILIATES shall not be required to take or refrain from taking any action impermissible or penalized under the laws of the United States or any applicable foreign jurisdiction, including without limitation the anti boycott laws administered by the U.S. Commerce and Treasury Departments.

 

ARTICLE 5. ORDERING

 

5.1                                 SINGULEX shall place its orders to purchase MPI PRODUCTS in writing, according to the e-mail, fax, or mailing information specified by the respective AUTHORIZED IIPH AFFILIATE.  With each order, SINGULEX must provide i) contact name, address, and fax, e-mail, or telephone number, ii) shipping address, iii) billing address, iv) quantity of each MPI PRODUCT and corresponding product number applicable to this AGREEMENT, v) purchase order number, and vi) appropriate customer account number.

 

5.2                                 Each order to purchase MPI PRODUCTS is subject to acceptance by the respective AUTHORIZED IIPH AFFILIATE, which acceptance may be accomplished by shipment of the corresponding MPI PRODUCTS within the next business day or by confirmation of the expected shipment date, as set forth in Article 8 (shipping and delivery), and which acceptance shall not be unreasonably withheld.

 

5.3                                 Each accepted purchase order shall be subject to the terms, conditions and provisions of this AGREEMENT and not to any other additional or contradictory terms printed on a purchase order or acknowledgment form.

 

5.4                                 After an order is accepted, the respective AUTHORIZED IIPH AFFILIATE may refuse any request for cancellation at its sole discretion.

 

5.5                                 Any quotation issued pursuant to this AGREEMENT shall be open for the period stated in the quotation, or if no period is stated, for 60 days.

 

5.6                                 Any duplicate order will be charged to SINGULEX unless the duplicate order is marked as “confirming.”

 

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ARTICLE 6. SPECIFICATIONS

 

6.1                                 MPI PRODUCTS shall be manufactured and packaged to meet MPI’s standard specifications as set forth in Exhibit D (specifications), which specifications are subject to change without advance notice to SINGULEX, but which are available upon request at any time.  Each time that SINGULEX places an order for MPI PRODUCTS, SINGULEX may request the lot-specific data for the current manufacturing lot of the particular MPI PRODUCT that SINGULEX wishes to order, so that SINGULEX may determine in its sole discretion if it is willing to accept shipment of that particular lot.  In the event a specification change to an MPI PRODUCT adversely affects the performance of one or more SINGULEX KITS, then except where the specification changes are necessary because of regulatory requirements or product safety concerns, SINGULEX shall be entitled to obtain the MPI PRODUCTS at the preceding specifications and packaging tolerances for such MPI PRODUCT at the preceding price, for a period of [***], and thereafter on a custom basis, at a reasonable price and minimum purchase requirements to be agreed between the Parties.

 

6.2                                 MPI shall prepare a Certificate of Analysis (C of A) and Material Safety Data Sheet (MSDS) for the MPI PRODUCTS, which will be supplied by the respective AUTHORIZED IIPH AFFILIATE with each shipment of such MPI PRODUCTS.  If SINGULEX does not receive such C of A or MSDS for any MPI PRODUCT with the shipment thereof, such C of A and MSDS shall be readily available from MPI upon request.  SINGULEX shall be responsible for distribution of information contained in the MSDS to its employees, and if such information is legally required to accompany materials transferred by SINGULEX, to THIRD PARTIES.

 

6.3                                 MPI may agree to establish specifications for an MPI PRODUCT that are different from the packaging format and/or the chemical make-up, purity, or other analytical characteristic set forth in MPI’s standard specifications, but no such different specification shall apply until it is agreed in writing by amendment of this AGREEMENT.  As between the Parties, any new discovery resulting from the development by MPI of MPI PRODUCT(S) with such different specifications shall belong exclusively to MPI.  Such different specifications may result in a change in the shipment schedule and may require the payment of an additional fee for the establishment or development thereof, and/or an increase in the price of the MPI PRODUCT supplied under such requested specifications, which price increase shall be separate from and in addition to any standard price increase that may occur pursuant to paragraph 7.2 (price change).

 

6.4                                 Although there may be parameters other than those set forth in this AGREEMENT that may determine the suitability of the MPI PRODUCTS for incorporation in SINGULEX CONJUGATES and SINGULEX KITS and the use thereof in the FIELD OF USE or in SINGULEX SERVICES, only the specifications for the MPI PRODUCTS that are specifically set forth in Exhibit D of this AGREEMENT or otherwise approved in writing by the Quality Manager of MPI shall be used to determine acceptance of the MPI PRODUCTS supplied hereunder.  SINGULEX shall be solely responsible for testing and determining the suitability of MPI PRODUCTS and SINGULEX CONJUGATES for use

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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in SINGULEX KITS and SINGULEX SERVICES, and any intended use or application thereof, and for communicating the appropriate cautionary information to subsequent purchasers and users of SINGULEX KITS.  SINGULEX shall be solely responsible for marking SINGULEX KITS to indicate the intended use in the FIELD OF USE for such SINGULEX KITS.

 

ARTICLE 7. PRICING FOR MPI PRODUCTS

 

7.1                                 The initial purchase price to SINGULEX for MPI PRODUCTS as of the EFFECTIVE DATE is set forth in Exhibit C (pricing), which includes a quantity discount schedule.  The quantity discount shall apply to purchases of multiple UNITS of a given MPI PRODUCT covered by a single purchase order, which may be supplied in multiple deliveries, provided that SINGULEX specifies delivery dates and UNITS of such MPI PRODUCT per delivery at the time that the purchase order is provided to the respective AUTHORIZED IIPH AFFILIATE, and where all such deliveries occur within the same YEAR.  Although different MPI PRODUCTS may be included in a single purchase order, the combined purchases of different MPI PRODUCTS shall not be used to determine the applicable discount.

 

7.2                                 The initial purchase price indicated in paragraph 7.1 (initial price) shall be subject to any standard price changes that are implemented by the respective AUTHORIZED IIPH AFFILIATE, according to the timing set forth in Exhibit C (pricing), which standard price changes shall be separate from, and/or in addition to any price change resulting from a change in the specifications for such MPI PRODUCT that is requested by SINGULEX pursuant to paragraph 6.3 (modified specifications), and which standard price changes shall be effective for any shipment that occurs after the date of implementation thereof, as set forth in Exhibit C (pricing).

 

ARTICLE 8. SHIPPING AND DELIVERY

 

8.1                                 Unless the respective AUTHORIZED IIPH AFFILIATE and SINGULEX agree otherwise in writing, the expected shipment date for MPI PRODUCTS shall be provided at the time the order is placed in accordance with Article 5 (ordering), where such order does not exceed SINGULEX’s then most recent forecast provided pursuant to paragraph 4.3 (forecasts); and within 60 days of acceptance of the order, where such order is in excess of the amount forecast; either of which schedules may be modified as set forth in paragraph 6.3 (modified specifications).

 

8.2                                 Upon acceptance of an order, MPI PRODUCTS shall be shipped FCA, Free Carrier the respective AUTHORIZED IIPH AFFILIATE shipping point, according to INCOTERMS 2000 (published by International Chamber of Commerce).  The respective AUTHORIZED IIPH AFFILIATE will prepay shipping charges, and will add the handling fee or shipping charges to the invoice.  In accordance with FCA, the risk of loss or of damage to the goods is transferred to SINGULEX as soon as the goods are shipped (i.e., delivered into the custody of the carrier).  SINGULEX is responsible for insurance for loss or damage during shipment.

 

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8.3                                 The respective AUTHORIZED IIPH AFFILIATE will select an appropriate method for protecting the MPI PRODUCTS during normal and customary handling in transit and meeting its obligations and regulatory requirements.  MPI reserves the right for each respective AUTHORIZED IIPH AFFILIATE to make delivery in installments, each such installment to be separately invoiced (including shipping charges).

 

8.4                                 Any shipment of MPI PRODUCTS may be postponed or terminated, as required by law.  In addition, if MPI or IIPH has reasonable grounds to dispute that SINGULEX is in compliance with a specified provision of this AGREEMENT, MPI and IIPH reserve the right to require pre-payment for, or suspend authorization for the respective AUTHORIZED IIPH AFFILIATE to transfer MPI PRODUCTS to SINGULEX until SINGULEX certifies its compliance with such specified provision.

 

8.5                                 SINGULEX shall pay the respective AUTHORIZED IIPH AFFILIATE for all purchases of MPI PRODUCTS according to the pricing as set forth in Article 7 (pricing), and the manner of payment set forth in paragraph 11.1 (payment methods).  Within 30 days after the date of the invoice, payment for the purchase of the invoiced MPI PRODUCTS, including shipping charges, shall be due.  SINGULEX shall be responsible for all taxes, assessments, duties, and other governmental fees of any nature whatsoever that are levied on MPI PRODUCTS upon shipment to SINGULEX.

 

ARTICLE 9. INSPECTIONS AND RETURNS

 

9.1                                 Any return of MPI PRODUCTS requires written authorization from the respective AUTHORIZED IIPH AFFILIATE, and a return authorization number.  Any claim for shipping discrepancies or damage must be made within 10 days of receipt of the shipment.  The error shall be resolved by mutual agreement, which may include return, replacement, reshipment, refund, etc., depending on the type and source of error.  Any credit for return of MPI PRODUCTS ordered in error will be contingent on the condition of the returned item and may be subject to a restocking fee.

 

9.2                                 Within 10 business days after SINGULEX receives a shipment of MPI PRODUCTS from the respective AUTHORIZED IIPH AFFILIATE, SINGULEX shall notify the respective AUTHORIZED IIPH AFFILIATE of any claim of a non-conforming MPI PRODUCT, but in any event prior to any use, modification or derivitization of the MPI PRODUCT.  The absence of any such notice within such period shall constitute acceptance of the MPI PRODUCTS by SINGULEX.  Within 15 business days after SINGULEX provides any such notice, SINGULEX shall receive notification whether such MPI PRODUCTS were non-conforming when shipped.  If such notification confirms that an MPI PRODUCT was non-conforming when shipped, reasonable efforts will be made to replace any non-conforming MPI PRODUCT within 30 days of such confirmation.  If such notification denies that such MPI PRODUCTS were non-conforming when shipped, MPI and SINGULEX shall use their reasonable commercial efforts to establish the cause of the discrepancy, and to resolve the matter.  SINGULEX shall arrange the disposal and destruction of any non-conforming MPI PRODUCTS or, at MPI’s request and expense, SINGULEX shall return the non-conforming MPI PRODUCTS to MPI.

 

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9.3                                 MPI and its AFFILIATES will not be responsible for any non-conformance that is due to any failure by the carrier or SINGULEX to handle or store MPI PRODUCTS as indicated on the label, specifications, or accompanying product information.

 

ARTICLE 10. PROPRIETARY RIGHTS, MARKETING AND TECHNICAL SUPPORT

 

10.1                           Multiple proprietary rights of IIPH are the basis of the licenses and options granted under this AGREEMENT.  For the convenience of the Parties, consideration for all licenses and options granted under this AGREEMENT are consolidated into SINGULEX’s purchase price of the MPI PRODUCT and a consolidated set of license and option payments by SINGULEX for such MPI PRODUCT, as set forth in Exhibit F (fees and royalties), which the Parties agree shall not be adjusted solely for incremental changes in the number or scope of such proprietary rights for such MPI PRODUCT, including expiration of one or more patents included in IIPH LICENSE RIGHTS, except as set forth in Exhibit F.

 

10.2                           As set forth in paragraph 3.3 (purchaser’s license), the transfer of SINGULEX KITS to END-USERS, as authorized hereunder, is accompanied by a label license for such END-USERS, limiting the right to use the SINGULEX KITS only in the FIELD OF USE.  SINGULEX shall mark all SINGULEX KITS and/or their accompanying product inserts, with the limited use label license that is set forth in Exhibit G (label license), or such other statement as IIPH may reasonably direct from time to time.  The requirement for such marking requirement does not relieve SINGULEX from the responsibility to distinguish SINGULEX KITS that may be subject to differing regulatory requirements, and SINGULEX shall be solely responsible for the appropriate regulatory markings for SINGULEX KITS.

 

10.3                           Consistent with the grant and limitations in Article 3 (scope of agreement), SINGULEX shall actively and diligently promote the sale of SINGULEX KITS and SINGULEX SERVICES.  SINGULEX understands, however, that there may be proprietary rights owned by THIRD PARTIES that may be necessary for the commercialization of SINGULEX KITS and SINGULEX SERVICES, and SINGULEX agrees that i) securing access to such THIRD PARTY rights is the responsibility of SINGULEX, and ii) neither IIPH nor any AFFILIATE of IIPH has any responsibility or liability with respect to any such THIRD PARTY proprietary rights.  This AGREEMENT confers no license or rights by implication, estoppel or otherwise under any existing or future patent application or patent owned by or licensed to IIPH or its AFFILIATES other than the patent applications and patents included in IIPH LICENSE RIGHTS, regardless of whether such patent applications or patents are dominant or subordinate to the patent applications or patents included in IIPH LICENSE RIGHTS.  SINGULEX will not be deemed to infringe any such existing or future patent as a result of SINGULEX’s exercise of its rights hereunder, provided that the basis of such alleged infringement of such existing or future patent does not relate to the (i) manufacture of MPI PRODUCTS supplied hereunder, or any derivative of such MPI PRODUCTS, or (ii) sale, offer for sale or import of materials other than the specific MPI PRODUCTS supplied hereunder, or conjugates of such MPI PRODUCTS in general (i.e., the patent does not relate to the specific material conjugated to an MPI PRODUCT), or (iii) use of any materials other

 

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than the specific MPI PRODUCTS supplied hereunder, or conjugates of such MPI PRODUCTS in general, that are used in the performance of SINGULEX SERVICES, or (iv) use of any methods other than methods that are expressly described in the patents and patent applications listed in Exhibit E, regardless of whether such methods so used are used in the performance of SINGULEX SERVICES or used to make SINGULEX CONJUGATES or SINGULEX KITS or any component thereof.

 

10.4                           SINGULEX shall not, and shall require its DISTRIBUTORS to not, advertise, promote, or sanction any use of the SINGULEX KITS other than for use in the licensed FIELD OF USE or in SINGULEX SERVICES.  SINGULEX shall indicate, and shall require its DISTRIBUTORS to indicate, in promotional materials, advertisements, and sales literature (including Web-based literature) that (i) SINGULEX KITS are licensed under patents or patent applications owned by Molecular Probes for use by END-USERS for use with SINGULEX’s digital molecule counting system for the applicable authorized FIELD OF USE, i.e., life science research, including clinical research, and human diagnostics, veterinary diagnostics, and/or biodefense and (ii) SINGULEX SERVICES are licensed by SINGULEX for providing assay development services and/or fee per test services, under patents or patent applications owned by Molecular Probes.  SINGULEX shall institute, and shall require its DISTRIBUTORS to institute, reasonable procedures (including training their respective sales force) to discourage and/or report to IIPH and MPI unauthorized use of SINGULEX KITS.  The requirement for such marking requirement does not relieve SINGULEX from the responsibility to distinguish SINGULEX KITS that may be subject to differing regulatory requirements, and SINGULEX shall be solely responsible for the appropriate regulatory markings for SINGULEX KITS.  However, nothing in this AGREEMENT will be construed as or deemed to constitute a warranty or guarantee by SINGULEX or any of its DISTRIBUTORS that END USERS will use the SINGULEX KITS in strict accordance with the restrictions set forth herein.

 

10.5                           Technical know-how may have been and may from time to time be transferred to SINGULEX by IIPH or its AFFILIATES regarding the use and/or optimization of MPI PRODUCTS relevant to the FIELD OF USE or SINGULEX SERVICES.  IIPH also authorizes MPI or other AUTHORIZED IIPH AFFILIATE to transfer technical know-how to SINGULEX, to the extent such transfer is reasonably necessary for the preparation of SINGULEX CONJUGATES to meet SINGULEX’s commercially reasonable quality control specifications.  The amount and timing of such transfer of know-how is entirely at the discretion of IIPH and MPI.  Unless otherwise agreed, no additional consideration is required for the transfer of technical know-how to SINGULEX or its AFFILIATES, and SINGULEX and its AFFILIATES assume sole responsibility for results obtained in reliance thereon.  IIPH and its AFFILIATES make no warranty regarding the sufficiency or accuracy of such transfer or such technical know-how.

 

10.6                           SINGULEX shall use the Alexa Fluor® trademark and product name, according to the product name format set forth in Exhibit B (MPI PRODUCTS), in product inserts, advertisements and sales literature (including Web based literature) when referring to the MPI PRODUCTS in SINGULEX KITS and, if applicable, SINGULEX SERVICES.

 

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SINGULEX shall use only displays, labels, forms, and other paper or similar products imprinted with such trademarks and colors as are prescribed from time to time by IIPH or MPI and SINGULEX shall acknowledge MPI’s ownership of the trademark when so used.  To preserve the validity and integrity of the trademarks licensed to SINGULEX hereunder, and the patent marking and limited use license labels required in paragraph 10.2 (marking requirements), and to assure that SINGULEX is making proper use of such trademarks and patent marking in the sale of SINGULEX KITS or SINGULEX SERVICES, prior to the commercial release of any of the following, SINGULEX shall offer IIPH, MPI and its agents the opportunity to reasonably audit or inspect relevant documentation, packaging, and marketing literature of SINGULEX for SINGULEX KITS and SINGULEX SERVICES.  If IIPH, MPI or their respective agents do not undertake any such advance audit or inspection, the SINGULEX documentation, packaging and/or marketing literature subject to that audit will be deemed approved.

 

10.7                           All uses and goodwill associated with the trademarks licensed under this AGREEMENT will inure to the benefit of MPI and IIPH.  SINGULEX shall not register, nor attempt to register, nor aid any AFFILIATE or THIRD PARTY in the foreign registration of any trademarks licensed in connection with the MPI PRODUCTS hereunder unless IIPH has given express written approval for such registration.  No right or license is granted to use the trademarks for MPI PRODUCTS licensed hereunder in connection with any materials that do not contain MPI PRODUCTS.

 

10.8                           MPI promotional and technical materials and publications, including electronic versions of such materials and publications displayed on the Web site of MPI or its AFFILIATES, are protected by copyright.  With regard to such works that originate with MPI or its AFFILIATES (i.e., they are not attributed to a THIRD PARTY), IIPH hereby grants SINGULEX the right to display, copy, and make derivative works of such materials and/or publications in whole or in part, as they relate to the MPI PRODUCTS for use in the FIELD OF USE or SINGULEX SERVICES; provided that SINGULEX first provides IIPH or MPI the opportunity to review and comment on any revisions to such materials and/or publications and receives the express prior written permission of IIPH, and SINGULEX acknowledges the respective copyright ownership.

 

10.9                           SINGULEX shall promptly notify IIPH and MPI in writing of any THIRD PARTY claim (each, a “Claim”) made against SINGULEX, its AFFILIATES, or its DISTRIBUTORS that (i) any MPI PRODUCT or combination thereof, including but not limited to, the way in which it is used or sold, or (ii) any other materials supplied hereunder, or (iii) any trademark licensed hereunder for use by SINGULEX in conjunction with any MPI PRODUCT, or SINGULEX KIT or SINGULEX SERVICE, infringes any copyright, trademark, patent or similar proprietary right of any party, or misappropriates any trade secret or similar proprietary right of any party.  IIPH and MPI shall determine, in their sole discretion, an appropriate response to such Claim.

 

IIPH and MPI will defend, indemnify and hold harmless SINGULEX and its Affiliates and their respective directors, officers, employees, consultants and agents (for purpose of this paragraph 10.9 and Article 15 below, “SINGULEX”) from and against any and all

 

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Claims, including reasonable attorney’s fees incurred in connection therewith, only to the extent set forth in Article 15 below.

 

10.10                     Prosecution of a THIRD PARTY for the infringing use of trademarks, copyrights or patents licensed hereunder may be undertaken by IIPH or MPI at their option.  SINGULEX shall provide information reasonably requested by IIPH or MPI in connection with such matters.

 

10.11                     IIPH and MPI will not actively promote the use of MPI PRODUCTS, or conjugates thereof, for use in combination with SINGULEX’s digital molecule counting instrument without the express permission of SINGULEX.

 

ARTICLE 11. PAYMENTS

 

11.1                           Unless otherwise mutually agreed in writing, all payments to:

 

a) IIPH shall be made by a check drawn on a bank in the United States, made out to INVITROGEN IP HOLDINGS, INC., and sent to:

 

Molecular Probes, Inc.
 Invitrogen Detection Technologies
 Attn: Accounting Department
 29851 Willow Creek Road
 Eugene, Oregon 97402-9132

 

b) the respective AUTHORIZED IIPH AFFILIATE, as applicable hereunder, shall be made by a check drawn on a bank in the United States and sent to the address indicated in Exhibit A.

 

11.2                           All amounts payable under this AGREEMENT to IIPH or the respective AUTHORIZED IIPH AFFILIATE shall be in the currency of the United States of America, or in the currency specified in the applicable invoice.  SINGULEX shall be responsible for any bank transfer fees.

 

11.3                           Late charges not to exceed the maximum amount allowed by law may be unilaterally added to invoices not paid within the specified payment term.  Where invoices for MPI PRODUCTS are not timely paid, subsequent shipments may be delayed or subject to prepayment until overdue amounts are paid.

 

11.4                           Within 30 days following the end of each QUARTER, SINGULEX shall furnish IIPH with a written report showing in reasonable detail its NET SALES for each different type of SINGULEX KIT or SINGULEX SERVICE sold or otherwise transferred for value, and TECHNOLOGY ACCESS FEES received, as well as SINGULEX KITS given away as free samples or replacements, during such QUARTER and accounting for amounts payable hereunder pursuant to paragraph 10.1 (proprietary rights) and Exhibit F (fees and royalties); or, so long as no SINGULEX KITS or SINGULEX SERVICES were sold or transferred or TECHNOLOGY ACCESS FEES received during such QUARTER, showing that no amount is payable for such period.  Such report shall include (i) gross

 

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sales in units and dollars for NET SALES of SINGULEX KITS, and an itemization of all DEDUCTIONS applied against gross sales of SINGULEX KITS within the FIELD OF USE; and (ii) the gross sales and actual costs used in the calculation of NET SALES for SINGULEX SERVICES; and (iii) gross sales in units and dollars for NET SALES of TECHNOLOGY ACCESS FEES.  Such report shall be sent to IIPH as set forth in paragraph 11.1 (payment address), which shall be accompanied by remittance of any and all royalties due for such QUARTER.

 

11.5                           Royalties accruing on sales in countries other than the United States shall be payable in United States dollars in amounts computed by first converting such sales into United States dollars based on the New York rate of exchange for the currency of such sales as quoted in the Wall Street Journal for the last business day of each QUARTER.  Royalties, License and Exercise Fees due to IIPH under this AGREEMENT shall not be reduced by any taxes, fees or other charges or withholding imposed by a government on the remittance of license income.  IIPH shall cooperate with SINGULEX to complete any paperwork necessary for SINGULEX to obtain an exemption from or refund of any such government charges or withholding.

 

11.6                           SINGULEX shall keep books of account in sufficient detail, in accordance with generally accepted accounting principles, to comply with the requirements of paragraph 11.4 (royalty reporting) and other terms of this AGREEMENT.  During the term of this AGREEMENT and for [***] YEARS following the YEAR in which the AGREEMENT expired or was terminated, SINGULEX shall permit an independent certified public accountant, selected by IIPH, to inspect those books of account, and other accounts, documents, materials and inventory in the possession or control of SINGULEX and relating to the manufacture and sale of SINGULEX KITS and SINGULEX SERVICES, and TECHNOLOGY ACCESS FEES received, during normal business hours to verify compliance with the terms of this AGREEMENT, but no more often than once in any 12- month period.  To facilitate such record keeping, SINGULEX shall ensure that all SINGULEX KITS held at or supplied from SINGULEX or its AFFILIATES shall bear a serial or lot number.  IIPH agrees that accounting information disclosed to the independent certified public accountant during such inspection shall be treated as SINGULEX’s CONFIDENTIAL INFORMATION.  The expense of such inspection shall be borne by IIPH unless the inspection indicates that SINGULEX has reported and paid less than [***] of the full amount of royalties due and owing to IIPH in any YEAR for any period covered by such inspection, in which case the expenses shall be borne by SINGULEX, in addition to payment of the underpayment, interest, and late payment charges that may be due.

 

ARTICLE 12. CONFIDENTIALITY

 

12.1                           Each Party agrees to maintain, and require its AFFILIATES and its and their employees to maintain, CONFIDENTIAL INFORMATION received from the other Party with the same degree of care it uses to protect its own CONFIDENTIAL INFORMATION, and each Party represents that it exercises reasonable care to protect its own CONFIDENTIAL INFORMATION.  Each Party agrees not to use, and require its AFFILIATES and its and their employees not to use, the CONFIDENTIAL

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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INFORMATION of the other Party for any purpose other than performing its obligations and exercising its rights under this AGREEMENT, except as otherwise explicitly set forth in this Article.  For purposes of Sections 12 through 14 herein, MPI and IIPH will be deemed to constitute a single “Party.”

 

12.2                           Each Party agrees to maintain in confidence and not to disclose to any THIRD PARTY, during and for [***] subsequent to the term of this AGREEMENT, any CONFIDENTIAL INFORMATION furnished by the other Party or its AFFILIATES hereunder.  With respect to any know-how that constitutes CONFIDENTIAL INFORMATION and is disclosed to a Party hereunder, the obligation to i) maintain such know-how in confidence, ii) not use such know-how for any purpose not expressly agreed herein, and iii) not disclose such know-how to any THIRD PARTY, shall survive in perpetuity.  SINGULEX shall not disclose any such know-how to MPI or its AFFILIATES without expressly identifying such know-how in writing as (i) know-how, and (ii) CONFIDENTIAL INFORMATION subject to non-disclosure under this AGREEMENT.

 

12.3                           Without granting any right or license to the use of its CONFIDENTIAL INFORMATION, except as specifically provided hereunder, each Party agrees that the limitations of non- use and non-disclosure of CONFIDENTIAL INFORMATION it provides to the other Party under this AGREEMENT shall not apply to such information, to the extent and only to the extent, that the receiving Party can credibly document that such information:

 

(i)                                     is now or hereafter becomes generally known or available to the public without the receiving Party’s breach of any obligation owed to the providing Party; or

 

(ii)                                  is independently developed by the receiving Party by employees having no access to CONFIDENTIAL INFORMATION of the providing Party, or was acquired by the receiving Party before receiving such information from the providing Party under this AGREEMENT, without restriction as to use or disclosure; or

 

(iii)                               is hereafter rightfully furnished to the receiving Party by an AFFILIATE or THIRD PARTY without any breach of an obligation of confidentiality to the providing Party and without restriction on use or disclosure; or

 

(iv)                              is disclosed or used by the receiving Party with the prior written consent of the providing Party.

 

12.4                           For purposes of clarifying paragraph 12.3 (confidentiality exclusions), information that is combined, synthesized or used by the providing Party in a particular manner, as provided to the receiving Party under this AGREEMENT, shall not be deemed “known”, “available”, “developed”, “acquired”, or “furnished” separately to the receiving Party merely because the various pieces of information were previously known, available, developed, acquired, or furnished without being so combined, synthesized or used.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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12.5                           A receiving Party may disclose CONFIDENTIAL INFORMATION if required to do so by applicable law, an administrative or court order, or governmental regulation; provided that the receiving Party promptly notifies the providing Party when it learns that disclosure may be required, and the receiving Party shall take reasonable action to avoid the disclosure or limit its scope.  Any information disclosed pursuant to this paragraph 12.5 will remain the CONFIDENTIAL INFORMATION of the providing Party and subject to this AGREEMENT.

 

12.6                           Each Party hereto may, without the prior written consent of the other Party, disclose the terms of this AGREEMENT to its AFFILIATES, or its lawyers or other paid consultants or advisors, under substantially the same terms as paragraphs 12.1 through 12.5 (confidentiality requirements), solely for the purpose of discussions related to business decisions of the disclosing Party.  Any information disclosed pursuant to this paragraph 12.6 will remain the CONFIDENTIAL INFORMATION of the providing Party and subject to this AGREEMENT.

 

12.7                           The terms of this AGREEMENT are deemed confidential, but either Party may disclose the existence of the AGREEMENT, without disclosing the terms, in a mutually-agreed media release or similar public announcement.

 

12.8                           No chemical structures for a given MPI PRODUCT shall be disclosed by SINGULEX without written permission from MPI.

 

ARTICLE 13. WARRANTIES

 

13.1                           Each Party represents and warrants to the other that (i) it is a company or corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is organized; and (ii) this AGREEMENT constitutes the legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms except as may be limited by bankruptcy or other similar laws or equitable principles relating to or limiting creditors’ rights generally.

 

13.2                           SINGULEX covenants that it shall not at any time do or cause to be done any act or omission, directly or indirectly, in any way impairing IIPH’s right, title, or interest in any IIPH LICENSE RIGHTS or in any underlying intellectual property licensed hereunder.

 

13.3                           SINGULEX acknowledges that the MPI PRODUCTS should be used with the same protective measures and degree of caution used with any chemical compound known to be potentially hazardous, and SINGULEX covenants that the use of MPI PRODUCTS by SINGULEX or its AFFILIATES shall be supervised by a technically qualified individual.

 

13.4                           MPI covenants that i) any MPI PRODUCT transferred to SINGULEX by MPI or its AFFILIATES pursuant to this AGREEMENT shall be delivered with full title, and ii) each MPI PRODUCT delivered to SINGULEX by MPI or its AFFILIATES under this AGREEMENT will substantially conform at the time of shipment to the specifications set forth in this AGREEMENT.

 

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13.5                           SINGULEX covenants that it shall manufacture and distribute SINGULEX KITS and perform SINGULEX SERVICES using commercially reasonable standards of care and quality and no less standards of care and quality than SINGULEX uses in the manufacture of other similar products or performance of other services.  IIPH and MPI shall have the right to visit and inspect the manufacturing facilities of SINGULEX upon reasonable notice and during normal business hours subject to approval by SINGULEX regarding timing of the visit, which approval shall not be unreasonably withheld.

 

ARTICLE 14. LIMITATION OF LIABILITIES

 

14.1                           NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, BUT EXCLUDING DAMAGES ARISING OUT OF A CLAIM THAT ONE PARTY HAS MISAPPROPRIATED OR MISUSED BY CONFIDENTIAL INFORMATION OR INTELLECTUAL PROPERTY OF ANOTHER PARTY HERETO, NEITHER PARTY AND NONE OF ITS AFFILIATES SHALL UNDER ANY CIRCUMSTANCES, BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL OR EXEMPLARY DAMAGES OF ANY KIND, ARISING OUT OF OR RELATED TO ANY TRANSACTION CONTEMPLATED HEREUNDER, INCLUDING BUT NOT LIMITED TO LOST PROFITS OR LOSS OF BUSINESS, EVEN IF SUCH PARTY OR ITS AFFILIATES IS APPRISED OF THE LIKELIHOOD OF SUCH DAMAGES OCCURRING.

 

14.2                           EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS STATED IN THIS AGREEMENT, NONE OF THE PARTIES HERETO AND THEIR RESPECTIVE AFFILIATES MAKE ANY ADDITIONAL WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED OR STATUTORY, AS TO ANY MATTER WHATSOEVER.  EACH OF IIPH, MPI, AND THEIR AFFILIATES EXPRESSLY DISCLAIM ANY AND ALL WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, INCLUDING ANY PURPOSE IN THE FIELD OF USE OR IN SINGULEX SERVICES, AND IIPH, MPI, AND THEIR AFFILIATES EXPRESSLY DISCLAIM ANY AND ALL WARRANTIES THAT THE USE OF MPI PRODUCTS, INCLUDING THE USE OF MPI PRODUCTS IN THE MANUFACTURE OF SINGULEX KITS OR ANY COMPONENT THEREOF, OR THE USE OR TRANSFER OF SUCH SINGULEX KITS OR COMPONENTS THEREOF BY OR TO ANY AFFILIATE OR THIRD PARTY, INCLUDING USE IN SINGULEX SERVICES, AND/OR ANY RESULTS OBTAINED BY USING SUCH MPI PRODUCTS OR SINGULEX KITS OR COMPONENT THEREOF ARE OR WILL BE FREE FROM INFRINGEMENT OF ANY PATENT OR OTHER RIGHTS OF THIRD PARTIES; AND THIS ALLOCATION OF RISK BETWEEN THE PARTIES IS REFLECTED IN THE TERMS OF THIS AGREEMENT AND IS AN ESSENTIAL ELEMENT OF THE BARGAIN BETWEEN THE PARTIES.  SINGULEX SHALL NOT HAVE THE RIGHT TO MAKE OR PASS ON, AND SHALL TAKE ALL MEASURES NECESSARY TO ENSURE THAT NEITHER IT NOR ANY OF ITS AGENTS, EMPLOYEES, AFFILIATES, OR DISTRIBUTORS, OR AGENTS OR EMPLOYEES THEREOF MAKE OR PASS ON, ANY SUCH WARRANTY OR REPRESENTATION ON BEHALF OF IIPH, MPI, OR ANY OF THEIR AFFILIATES TO ANY END-USER OR OTHER THIRD PARTY.

 

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14.3                           UNDER NO CIRCUMSTANCES SHALL THE TOTAL LIABILITY OF ALL KINDS, OF IIPH, MPI AND THEIR AFFILIATES, ARISING OUT OF OR RELATED TO THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTY CLAIMS HEREUNDER, REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT, TORT, OR ANY OTHER LEGAL THEORY, EXCEED [***] (DETERMINED AS OF THE DATE OF ANY FINAL JUDGMENT IN SUCH ACTION).

 

14.4                           IT IS EXPRESSLY UNDERSTOOD AND AGREED THAT EACH AND EVERY PROVISION OF THIS AGREEMENT WHICH PROVIDES FOR A LIMITATION OF LIABILITY, DISCLAIMER OF WARRANTIES OR EXCLUSION OF DAMAGES, IS INTENDED BY THE PARTIES TO BE SEVERABLE AND INDEPENDENT OF ANY OTHER PROVISION AND TO BE ENFORCED AS SUCH.

 

14.5                           SINGULEX’s exclusive remedy under this AGREEMENT with regard to the supply of MPI PRODUCTS, and the entire liability hereunder of IIPH, MPI, and their AFFILIATES in contract, tort, or otherwise, shall be for MPI or other respective AUTHORIZED IIPH AFFILIATE to use reasonable efforts to provide replacement for any non-conforming MPI PRODUCTS, provided that notice of non-conformance is received as per paragraph 9.2 (non-conformance claims).  If however, after repeated efforts, MPI or other respective AUTHORIZED IIPH AFFILIATE is unable to provide MPI PRODUCTS in conformance with the specification agreed hereunder, then SINGULEX’s exclusive remedy under this AGREEMENT and the entire liability hereunder of IIPH, MPI, and their AFFILIATES in contract, tort or otherwise is to refund the amount paid by SINGULEX for the non-conforming MPI PRODUCTS, or to authorize the manufacture of MPI PRODUCTS by a THIRD PARTY manufacturer pursuant to paragraph 3.4.  Notwithstanding the foregoing, IIPH, MPI, and their AFFILIATES shall have no liability for MPI PRODUCTS that are (i) not used in the FIELD OF USE or in SINGULEX SERVICES, and/or (ii) not supplied by MPI or other AUTHORIZED IIPH AFFILIATE.  Notwithstanding the foregoing, if MPI or an AUTHORIZED IIPH AFFILIATE fails twice during the Term hereof to provide MPI PRODUCTS which conform to their respective specifications, SINGULEX may terminate this Agreement without any further obligation or liability to MPI or IIPH hereunder.

 

14.6                           SINGULEX shall maintain in effect product liability insurance, in an amount of at least [***], regarding the sale of SINGULEX KITS and naming IIPH and MPI as additional insureds.

 

ARTICLE 15. INDEMNIFICATION

 

15.1                           Excluding any Claims subject to indemnification by MPI, IIPH or any of their respective AFFILIATES under paragraph 15.3 below, SINGULEX shall indemnify, defend and hold harmless IIPH, MPI, and their AFFILIATES, and their respective directors, officers, employees, and agents (“Indemnitees”), from and against any and all claimed liabilities, including any liabilities claimed by any THIRD PARTY and including but not limited to demands, expenses (including, without limitation, costs of investigation, attorneys and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

22

 

professional fees and other costs of litigation, and to the extent permitted by law, fines, penalties and forfeitures in connection with any proceedings against the Indemnitees), losses or causes of action, and settlement amounts, to the extent that such claimed liabilities arise out of or relate in any way to the possession, manufacture, use, sale, transfer, distribution or other disposition of SINGULEX KITS or component thereof, or performance of SINGULEX SERVICES whether or not in combination with other substances, by or on behalf of SINGULEX, its AFFILIATES, or its or their distributors, whether based on breach of warranty, negligence, infringement, misappropriation, product liability or otherwise, except to the extent that such claimed liabilities are the result of negligence or willful misconduct by IIPH, MPI, or other AUTHORIZED IIPH AFFILIATE.  SINGULEX shall defend against any such claimed liabilities at its own expense, provided that IIPH or MPI promptly notifies SINGULEX on learning of such claimed liabilities and cooperates with SINGULEX in such defense.

 

15.2                           Excluding any Claims subject to indemnification by MPI, IIPH or any of their respective AFFILIATES under paragraph 15.3 below, SINGULEX shall indemnify, defend and hold harmless IIPH, MPI, and their AFFILIATES, and their respective directors, officers, employees, and agents (“Indemnitees”), from and against any and all liabilities, claims, demands, expenses (including, without limitation, costs of investigation, attorneys and professional fees and other costs of litigation, and to the extent permitted by law, fines, penalties and forfeitures in connection with any proceedings against the Indemnitees), losses or causes of action, and settlement amounts, arising out of or relating in any way to alleged infringement or misappropriation of a THIRD PARTY’s intellectual property, to the extent that the liabilities, claims, demands, expenses, losses or causes of action for alleged infringement or misappropriation are due to the manufacture, sale, or use of SINGULEX KITS, or to the combination of MPI PRODUCTS with other products or components, or to the sale or use of any component in the SINGULEX KITS, or to the performance of SINGULEX SERVICES.  SINGULEX shall defend any such claims of alleged infringement or misappropriation at its own expense, provided that IIPH or MPI promptly notifies SINGULEX on learning of such claims and cooperates with SINGULEX in defending any such claim.

 

15.3                           With respect to the indemnification obligations of IIPH and MPI under paragraph 10.9 above and this Article 15, and subject to the limitations in Article 14, IIPH and MPI will defend, indemnify and hold SINGULEX and its AFFILIATES and their respective directors, officers, employees, and agents harmless from and against any and all Claims, including reasonable attorneys’ fees related thereto, incurred by SINGULEX due to (i) the breach of any law or regulation arising out of, the manufacture of any MPI PRODUCT by MPI or its AFFILIATES hereunder, or the sale of any MPI PRODUCT by MPI or its AFFILIATES to SINGULEX hereunder; (ii) the infringement of any copyright, trademark, patent or similar proprietary right of any party, or misappropriation any trade secret or similar proprietary right of any THIRD PARTY by the manufacture of any MPI PRODUCT by MPI or its AFFILIATES hereunder, or the sale of any MPI PRODUCT by MPI or its AFFILIATES to SINGULEX hereunder or (iii) the negligence or willful misconduct of IIPH and/or MPI; except to the extent any such Claims are subject to indemnification by SINGULEX or any of its AFFILIATES under paragraphs 15.1 or 15.2 above.

 

23

 

15.4                           SINGULEX shall promptly notify IIPH and MPI in the event any dispute with a THIRD PARTY, including but not limited to those contemplated in paragraphs 10.9, 15.1, or 15.2 (third party claims), relates to the validity of any IIPH LICENSE RIGHTS or to the underlying intellectual property included therein, and SINGULEX shall not settle any dispute with any THIRD PARTY by admitting infringement of any THIRD PARTY intellectual property right by any MPI PRODUCT, use of any MPI PRODUCT, or combination of any MPI PRODUCT with another product or component.  SINGULEX shall not disclaim any intellectual property right of IIPH, MPI, or their AFFILIATES, as licensed hereunder, without the express written consent of IIPH.  In the event that an MPI PRODUCT as manufactured by MPI cannot be reasonably modified to avoid such alleged infringement of such THIRD PARTY intellectual property right, and none of the Parties acquires a commercially reasonable license from such THIRD PARTY for the continued supply of such MPI PRODUCT by MPI or an AUTHORIZED AFFILIATE, each Party reserves the right to suspend the relevant portion of its performance under this AGREEMENT or to terminate the relevant portion of this AGREEMENT, without any further liability to the other Parties, in settlement of such suit or proceeding alleging such infringement of THIRD PARTY intellectual property rights, but not to otherwise limit the business or proprietary rights of the other Parry or Parties without the prior written approval of such other Party or Parties.

 

ARTICLE 16. TERM AND TERMINATION

 

16.1                           This AGREEMENT shall commence on the EFFECTIVE DATE and, unless terminated earlier pursuant to this Article, this AGREEMENT shall be for the life of the last-to expire patent(s) (Exhibit E) that pertain to the MPI PRODUCTS selected by SINGULEX pursuant to paragraph 3.2.  Upon expiration or earlier termination of this AGREEMENT, all rights of SINGULEX to (i) use IIPH LICENSE RIGHTS, (ii) use any MPI PRODUCT selected and supplied hereunder, (iii) sell or otherwise transfer such selected MPI PRODUCTS incorporated in SINGULEX KITS, to any AFFILIATE or THIRD PARTY, (iv) use such selected MPI PRODUCTS incorporated in SINGULEX CONJUGATES or SINGULEX KITS in SINGULEX SERVICES, and (v) select additional MPI PRODUCTS, shall likewise expire or terminate.

 

16.2                           SINGULEX may terminate this AGREEMENT by providing 30 days written notice in accordance with paragraph 17.1 at any time after SINGULEX [***].

 

16.3                           In the event that no purchases of an MPI PRODUCT are made for a consecutive 12-month period, IIPH or MPI may, at their election, terminate this AGREEMENT with respect to such MPI PRODUCT upon 60 days prior written notification to SINGULEX according to paragraph 17.1 (notice requirements).

 

16.4                           If either SINGULEX on the one hand, or IIPH or MPI on the other hand, breaches any material condition of this AGREEMENT, the aggrieved Party may give written notice of the alleged breach to the other Party.  A failure on the part of an AFFILIATE of a Party to comply with the terms of this AGREEMENT shall constitute a breach of this AGREEMENT by such Party.  After such notification, if such breach is not remedied or resolved during the dispute resolution period as set forth in Article 18 (dispute

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

24

 

resolution), the aggrieved Party may, at its election, terminate this AGREEMENT immediately upon written notice.

 

16.5                           If SINGULEX enters into liquidation (excepting liquidation of a solvent company for organizational purposes) or makes an assignment for the benefit of creditors, or if proceedings for voluntary bankruptcy are instituted on behalf of SINGULEX, or if SINGULEX is declared bankrupt or insolvent, either MPI or IIPH may, at its election, terminate this AGREEMENT immediately by giving written notice of termination to SINGULEX, subject to restrictions on termination under applicable bankruptcy laws.

 

16.6                           Except where the assignment or transfer of this AGREEMENT is authorized in accordance with paragraph 19.2 (assignment), IIPH or MPI may, at their election, terminate this AGREEMENT on SINGULEX’s assignment or transfer of this AGREEMENT to a THIRD PARTY.

 

16.7                           IIPH or MPI shall have the right to terminate this AGREEMENT, on a country-by-country basis, if SINGULEX, after the EFFECTIVE DATE, institutes a suit, nullity action, opposition to grant, or other legal action in that country, seeking to invalidate the claims of a patent or patent application included in IIPH LICENSE RIGHTS, or if SINGULEX actively participates (other than by legal compulsion) in any of the foregoing.

 

16.8                           Expiration or termination of this AGREEMENT for any reason shall not release any Party hereto from any liability which, at the time of such expiration or termination, has already accrued to the benefit of the other Party or which is attributable to a period prior to such expiration or termination nor preclude any Party from pursuing any rights and remedies it may have hereunder or at law or in equity with respect to any breach of this AGREEMENT.  In particular, SINGULEX’s payment obligations set forth in Exhibit F (fees and royalties), shall survive any termination of this AGREEMENT by IIPH or MPI pursuant to paragraphs 16.3 through 16.7 (grounds for termination), with respect to SINGULEX CONJUGATES, SINGULEX KITS, or SINGULEX SERVICES manufactured or sold prior to the termination date.  However, for the avoidance of doubt, SINGULEX’s Minimum Annual Royalty obligation for a given YEAR will not survive any termination of this AGREEMENT for the remaining months in such YEAR, or any YEAR after termination, where the termination is (i) for cause by SINGULEX under paragraph 16.4 above and (ii) as expressly set forth in paragraph 15.4 above.

 

16.9                           Upon any expiration or termination of the AGREEMENT, each Party shall promptly return to the providing Party, at its request, all CONFIDENTIAL INFORMATION of the providing Party, or verification by an authorized signatory of the receiving Party that all such CONFIDENTIAL INFORMATION was destroyed.  However, one copy may be retained in the receiving Party’s legal files for purposes of record keeping.

 

16.10                     Articles 12 (confidentiality), 13 (warranties), 14 (limitation of liabilities), 15 (indemnification), and 18 (dispute resolution), and paragraphs 11.6 (records), 16.8 (accrued liability), 16.9 (copy of CONFIDENTIAL INFORMATION), and this

 

25

 

paragraph shall survive the expiration or termination of this AGREEMENT for any reasons.

 

ARTICLE 17. NOTICE

 

17.1                           Any notices required or permitted to be given under this AGREEMENT shall be deemed given on the date submitted in writing:

 

personally; or

 

by a letter delivered to a courier guaranteeing next day service; or

 

by facsimile, with confirmation by prepaid first class letter sent the same day.

 

	
If   to IIPH:
    	
 
    	
INVITROGEN   IP HOLDINGS, INC.
    
	
 
    	
 
    	
Attention:   PRESIDENT
    
	
 
    	
 
    	
1600   Faraday Avenue
    
	
 
    	
 
    	
Carlsbad,   CA 92008
    
	
 
    	
 
    	
Facsimile:   760-476-6326
    
	
 
    	
 
    	
 
    
	
If   to MPI:
    	
 
    	
MOLECULAR   PROBES, INC.
    
	
 
    	
 
    	
Attention:   BUSINESS DEVELOPMENT DEPARTMENT
    
	
 
    	
 
    	
29851   Willow Creek Road
    
	
 
    	
 
    	
Eugene,   OR 97402-9132
    
	
 
    	
 
    	
Facsimile:   541-335-0354
    
	
 
    	
 
    	
 
    
	
with   a copy to
    	
 
    	
INVITROGEN   CORPORATION
    
	
 
    	
 
    	
Attention:   LEGAL DEPARTMENT (Contracts)
    
	
 
    	
 
    	
1600   Faraday Avenue
    
	
 
    	
 
    	
Carlsbad,   CA 92008
    
	
 
    	
 
    	
Facsimile:   760-476-6326
    
	
 
    	
 
    	
 
    
	
If   to SINGULEX:
    	
 
    	
SINGULEX, INC.
    
	
 
    	
 
    	
Attention:   Philippe Goix
    
	
 
    	
 
    	
4041   Forest Hill Avenue
    
	
 
    	
 
    	
St.   Louis, MO 63108
    
	
 
    	
 
    	
Facsimile:   (314)
    

 

17.2                           Any Party may change its designated address and facsimile number by notice to the other Party in the manner provided in this Article.

 

ARTICLE 18. DISPUTE RESOLUTION

 

18.1                           In the event any Party claims breach of this AGREEMENT, the Parties shall consult with each other in good faith on the most effective means to cure the breach and to achieve any necessary restitution of its consequences.  This consultation shall be undertaken within a period of ten days following the receipt of a written request to consult, and the consultation period shall not exceed 30 days.  During the consultation period, neither

 

26

 

litigation nor arbitration may be pursued until attempts at consultative dispute resolution have been exhausted.

 

18.2                           Any dispute between the Parties arising out of or related to this AGREEMENT and not resolved by consultation as provided in paragraph 18.1, shall be finally settled by binding, expedited arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association (“Rules”) then in effect.  The arbitration proceeding shall be conducted in the State of California, and carried out by a panel of three arbitrators, selected according to such Rules.  If either Party refuses to submit to arbitration as agreed hereunder, such Party may be compelled to arbitrate under the California Code of Civil Procedure.  Each Party shall be responsible for any costs or expenses incurred in presenting such Party’s case to the arbitrators, such as attorneys’ fees or expert witness fees, and all other fees and expenses shall initially be paid equally by the Parties, subject to reimbursement in the final award.  The arbitration award shall allocate fees, expenses, and damages in a way that bears a reasonable relationship to the outcome of the arbitration, with the Party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees, expenses, and damages.  The decision of the arbitrators shall be final and binding on the Parties, provided however that the arbitrators shall not have the authority to alter any explicit provision of the AGREEMENT.  The arbitration award may be enforced in any court having jurisdiction over the Parties and the subject matter of the arbitration, except that this paragraph shall not apply to, and no arbitration proceeding shall deal with, disputes relating to the issues of the scope, validity and/or enforceability of any of the intellectual property licensed to any Party hereunder.

 

ARTICLE 19. MISCELLANEOUS

 

19.1                           Amendments.  No change, modification, extension, termination, or waiver of this AGREEMENT, or any of the provisions herein contained, shall be valid unless made in writing and signed by duly authorized representatives of the Parties hereto, except as expressly provided herein.

 

19.2                           Assignment.  Neither this AGREEMENT nor any rights or benefits hereunder shall be assignable or transferable by SINGULEX, in whole or in part, without the written consent of IIPH and MPI other than to a SINGULEX AFFILIATE or to a THIRD PARTY which acquires all or substantially all of SINGULEX’s business or assets or otherwise assumes CONTROL of SINGULEX or a material division thereof which requires continued access to the MPI PRODUCTS, whether by merger, acquisition, spin-off of a business division or otherwise.  For purposes of clarification, any such assignment or transfer would result in one and only one business entity having rights to this AGREEMENT, and the AGREEMENT would only be transferable in whole and not in part to any entity.  Any purported assignment by SINGULEX not in accordance with this paragraph shall be void.  MPI and IIPH shall have the right to assign this AGREEMENT to an AFFILIATE or an acquirer of substantially all of such Party’s assets related to the performance of this AGREEMENT.

 

27

 

19.3                           Binding Effect.  This AGREEMENT shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties.

 

19.4                           Counterparts.  This AGREEMENT may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

19.5                           Exhibit Incorporation.  All Exhibits cited herein are incorporated by reference and made a part of this AGREEMENT.

 

19.6                           Force Majeure.  Any failure or delay in performance by either Party to this AGREEMENT, caused by an event beyond the reasonable control of such Party, shall not be deemed a breach of this AGREEMENT, such causes including but not limited to: natural disasters; insurrections and other hostilities; acts of governments or government agencies; unavailability of transportation or raw materials; and strikes or other labor disturbances.  On occurrence of any such event, the Party whose performance is affected shall promptly give notice to the other Party and its best estimate of the extent and duration of its effect.  The term of this AGREEMENT shall then be suspended for a corresponding period of time.  If such period of suspension lasts for a period of six months, the Party not affected by such event shall be entitled to terminate this AGREEMENT by providing at least one-month notice.

 

19.7                           Governing Law and Venue.  This AGREEMENT and all matters connected with the performance thereof shall be governed by and construed and enforced in accordance with the laws of the State of California without regard to conflict of laws provisions, except that any dispute with respect to infringement, validity, or enforceability of any patent or published patent application shall be governed by and construed and enforced in accordance with the laws of the jurisdiction in which such patent is issued or such patent application is published.  Any litigation or other dispute resolution between the Parties relating to this AGREEMENT shall take place in California.  By executing this AGREEMENT, the Parties consent to personal jurisdiction of, and venue within, the state and federal courts of the State of California.  The Parties agree that the provisions of the United Nations Convention on Contracts for the International Sale of Goods will not apply to this AGREEMENT or to the transactions conducted under this AGREEMENT.

 

19.8                           Headings.  The Article and paragraph headings, and paragraph parenthetical cross-references contained herein are for the purposes of convenience of reference only and are not intended to define or limit the contents of said Articles or paragraphs.

 

19.9                           Independent Contractors.  Nothing in this AGREEMENT is intended nor is to be construed as to constitute the Parties as partners, joint venturers, or principal and agent with respect to this AGREEMENT.  Except between IIPH and MPI, no Party shall have any express or implied authority to bind any other Party to any other agreement, contract, obligation or undertaking with any THIRD PARTY.

 

19.10                     Interpretation.  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

 

28

 

include all genders.  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 or local holiday, the Party having such privilege or duty shall have until 5:00 pm 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.  Since the Parties have participated jointly in the negotiation and drafting of this AGREEMENT, in the event an ambiguity or question of interpretation arises, no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of authorship of any provision of this AGREEMENT.

 

19.11                     Prior Agreements.  This AGREEMENT together with the Exhibits hereto, sets forth the entire understanding between the Parties with respect to the matters dealt with herein and supersedes any and all prior agreements, written or oral, previously entered into by the Parties covering the matters dealt with herein.

 

19.12                     Severability.  If any provision of this AGREEMENT is in violation of any law or is found to be otherwise unenforceable by a court or competent administrative body from which there is no appeal, or no appeal is taken, such provision shall be deleted and the Parties shall negotiate in good faith to substitute for any such invalid or unenforceable provision, a valid and enforceable provision that achieves to the greatest extent possible the economic, legal and commercial objectives of the invalid or unenforceable provision.

 

19.13                     Waiver.  No delay on the part of any Party hereto in exercising any power or right hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any power or right hereunder preclude other or further exercise thereof or the exercise of any other power or right.

 

29

 

Each of the undersigned represents and warrants that he is duly authorized to execute this AGREEMENT and thereby bind his respective Party and that all required approvals have been obtained for the execution of this AGREEMENT, which AGREEMENT shall be binding on the Parties as of the EFFECTIVE DATE.  For purposes hereof, a facsimile of a signed copy shall have the same force and effect as an original signed AGREEMENT.

 

	
MOLECULAR   PROBES, INC.
    	
 
    	
SINGULEX, INC.
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   August J. Sick
    	
 
    	
By:
    	
/s/   Philippe Goix
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name/Title:
    	
August J.   Sick
    	
 
    	
Name/Title:
    	
Philippe   Goix
    
	
 
    	
General   Manager
    	
 
    	
 
    	
President   and CEO
    
	
 
    	
 
    	
 
    
	
Date:
    	
6/26/06
    	
 
    	
Date:
    	
7-05-2006
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
INVITROGEN   IP HOLDINGS, INC.
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   August J. Sick
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Name/Title:
    	
August J.   Sick
    	
 
    	
 
    
	
 
    	
General   Manager
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Date:
    	
6/29/06
    	
 
    	
 
    
									

 

30

 

Exhibit A: AUTHORIZED IIPH AFFILIATES

 

For the purchase of MPI PRODUCTS that will be incorporated into SINGULEX CONJUGATES in the United States, the AUTHORIZED IIPH AFFILIATE is:

 

MOLECULAR PROBES, INC.
 INVITROGEN DETECTION TECHNOLOGIES
 29851 Willow Creek Road
 Eugene, Oregon 97402
 Toll Free Phone: (800) 438-2209
 Fax: (541) 335-0305
 E-mail: order@probes.com 
 Web: http://probes.invitrogen.com

 

31

 

Exhibit B: MPI PRODUCTS

 

MPI PRODUCTS that are available to be supplied under this AGREEMENT, for use as set forth in Article 3 (scope of agreement), are identified in the following table:

 

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

32

 

Exhibit C: Pricing of MPI PRODUCTS(1)

 

	
MPI PRODUCT
    	
 
    	
Initial 
   Purchase 
   Price to 
   SINGULEX
    	
 
    	
Standard Price 
   Change
    	
 
    	
Quantity Discount Schedule
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
 
    

 

(1) Subject to the provisions of paragraph 4.1 (source of supply) and Article 7 (pricing)

 

(2) Available upon request, based on the information that is posted on the Web site of the respective AUTHORIZED IIPH AFFILIATE for the country of United States, at the time the order for the MPI PRODUCT is accepted by the respective AUTHORIZED IIPH AFFILIATE.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

33

 

Exhibit D: Specifications

 

Consistent with Article 6 (specifications), each MPI PRODUCT shall be manufactured and packaged to meet MPI’s standard specifications that are applicable, at the time the MPI PRODUCT is shipped, for the manufacturing lot of that MPI PRODUCT, which specifications are available on request, and which are subject to change at any time or in accordance with paragraph 6.3 (modified specifications).

 

34

 

Exhibit E: IIPH LICENSE RIGHTS

 

Patents/Patent Applications

 

[***]

 

Trademarks

Alexa Fluor®

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

35

 

Exhibit F: Fees and Royalties

 

Fees

 

In consideration of the rights and options granted under this AGREEMENT, SINGULEX shall pay the one-time, non-creditable, non-refundable License Fee to IIPH set forth in the table at the end of this paragraph, to the payment address set forth in paragraph 11.1.

 

For each additional MPI PRODUCT selected by SINGULEX pursuant to paragraph 3.2 (options for products), SINGULEX shall pay IIPH an additional non-creditable, non-refundable, one-time Exercise Fee as set forth in the table F.1. at the end of this paragraph.  Payment of the appropriate Exercise Fee shall be received by IIPH at least [***] prior to the commercialization of such additional MPI PRODUCT under this AGREEMENT.

 

Table F.1.

 

[***]

 

(1) License fee: [***].

 

(2) Exercise fee: Due and payable [***].  For the avoidance of doubt, without payment of the applicable Exercise Fee, SINGULEX may use any of these MPI PRODUCTS for [***].  If SINGULEX desires to use an MPI PRODUCT for [***].

 

Royalties

 

In further consideration of the rights granted under this AGREEMENT, SINGULEX shall pay IIPH [***], to be sent to the payment address set forth in paragraph 11.1.  Royalty obligations shall accrue when the SINGULEX CONJUGATE is made, or access to SINGULEX technology is granted, and payments shall be payable to IIPH within [***], and shall be sent to IIPH in conjunction with the report due to IIPH under paragraph 11.4 (royalty reporting).  As set forth in the AGREEMENT, no royalties shall be due for free replacements or nominal quantities of free samples, or internal routine testing of nominal quantities of SINGULEX CONJUGATES for purposes of quality control, product development, product testing, sales demonstrations, and other internal, non-revenue generating uses of SINGULEX CONJUGATES.

 

Table F.2.

 

[***]

 

(1) In the event that SINGULEX KITS or SINGULEX SERVICES contain or utilize BLOCKING THIRD PARTY INTELLECTUAL PROPERTY, SINGULEX shall be permitted to [***], provided however, that in no such case will the final royalty paid to IIPH be less than [***] of its initial value in such country(ies).

 

Annual Minimum Royalties

 

Beginning in 2006, SINGULEX shall pay IIPH an Annual Minimum Royalty on NET SALES of SINGULEX KITS, SINGULEX SERVICES, and TECHNOLOGY ACCESS FEES as set forth in the table F.3. at the end of this paragraph.  To the extent that the total running royalties for

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

36

 

such NET SALES payable in any YEAR to IIPH are less than the Annual Minimum Royalty for that YEAR, SINGULEX shall pay the shortfall to IIPH together with its royalty payment for the last QUARTER of that YEAR.

 

Table F.3.

 

	
YEAR
    	
 
    	
Annual Minimum Royalty
    	
 
    
	
2006
    	
 
    	
[***]
    	
 
    
	
2007
    	
 
    	
[***]
    	
 
    
	
2008,   and each subsequent YEAR that this AGREEMENT is in effect
    	
 
    	
$
    	
50,000
    	
 
    
					

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

37

 

Exhibit G: Label Licenses

 

This product is subject to an agreement between Molecular Probes, Inc. and Singulex, Inc., and the manufacture, use, sale or import of this product may be subject to one or more of U.S. patents, pending applications and corresponding foreign equivalents, owned by Molecular Probes, Inc. (a wholly owned subsidiary of Invitrogen Corporation).  The purchase of this product conveys to the buyer the non-transferable right under such patents to use the purchased amount of the product and components of the product, in combination with Singulex’s digital molecule counting system for the use specified on the label or in accompanying product literature, which is limited to one or more of (i) life science research, including clinical research, (ii) human diagnostics; [***].  The buyer cannot use this product or its components for manufacturing or for [***], or sell or otherwise transfer this product or its components to any third party, or use for any use other than for the use specified on the label or in the accompanying product literature.  For information on purchasing a license to this product for purposes other than the use specified, contact Molecular Probes, Inc., Business Development, 29851 Willow Creek Road, Eugene, OR 97402, USA, Tel: (541) 465-8300.  Fax: (541) 335-0504.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

38

 

COMPANY NAME
 Royalty Worksheet

 

Payable **Quarterly” to Molecular Probes, Inc.

 

March, June, September, December plus XX Days

 

Royalty payable at XX% of Sales

 

Make Payments to:                  Molecular Probes, Inc.
 Attn: Accounting
 29851 Willow Creek Rd.
 Eugene, OR 97402

 

	
Date
    	
 
    	
Prod #
    	
 
    	
Quantity
    	
 
    	
Sales
    	
 
    	
Royalty
    
	
1st   Quarter
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
January
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
January Total
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
February
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
February Total
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
March
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
March Total
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1st   Quarter January
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
January
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
February
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
March
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
1st   Quarter Summary Total
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

39

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00208-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00208-of-00352.parquet"}]]