Exhibit 10.10


 


 


LICENSE
AGREEMENT


 


For




MEASUREMENT
OF LIPOPROTEIN SUBSPECIES



Between



BERKELEY HEARTLAB, INC.



and



THE REGENTS OF THE UNIVERSITY OF CALIFORNIA



through the




Ernest
Orlando Lawrence

BERKELEY NATIONAL LABORATORY


 


[***] indicates
material that has been omitted pursuant to a request for confidential
treatment. The omitted material has been filed separately with the Securities
and Exchange Commission.


 

















 


 


TABLE OF CONTENTS


 


	
  1.
  BACKGROUND

  	
  1

  
	
  2.
  DEFINITIONS

  	
  1

  
	
  3.
  LICENSE GRANT

  	
  3

  
	
  4.
  LICENSE ISSUE FEE

  	
  3

  
	
  5.
  ROYALTIES AND PAYMENTS

  	
  3

  
	
  6.
  PERFORMANCE REQUIREMENTS

  	
  5

  
	
  7.
  PROGRESS AND ROYALTY REPORTS

  	
  6

  
	
  8.
  BOOKS AND RECORDS

  	
  7

  
	
  9.
  LIFE OF THE AGREEMENT

  	
  7

  
	
  10.
  TERMINATION BY BERKELEY LAB

  	
  7

  
	
  11.
  TERMINATION BY HEARTLAB

  	
  7

  
	
  12.
  DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION

  	
  8

  
	
  13.
  USE OF NAMES AND TRADEMARKS AND NONDISCLOSURE OF AGREEMENT

  	
  8

  
	
  14.
  LIMITED WARRANTY

  	
  8

  
	
  15.
  PATENT PROSECUTION AND MAINTENANCE

  	
  9

  
	
  16.
  PATENT INFRINGEMENT

  	
  10

  
	
  17.
  WAIVER

  	
  10

  
	
  18.
  ASSIGNMENT

  	
  10

  
	
  19.
  INDEMNIFICATION

  	
  11

  
	
  20. LATE
  PAYMENTS

  	
  11

  
	
  21.
  NOTICES

  	
  12

  
	
  22.
  U.S. MANUFACTURE

  	
  12

  
	
  23.
  PATENT MARKING

  	
  12

  
	
  24.
  GOVERNMENT APPROVAL OR REGISTRATION

  	
  12

  
	
  25.
  EXPORT CONTROL LAWS

  	
  13

  
	
  26.
  FORCE MAJEURE

  	
  13

  
	
  27.
  MISCELLANEOUS

  	
  13

  



 


[***] indicates
material that has been omitted pursuant to a request for confidential
treatment. The omitted material has been filed separately with the Securities
and Exchange Commission.


 

















 


L-97-1203


 


 


LICENSE AGREEMENT FOR

MEASUREMENT OF LIPOPROTEIN SUBSPECIES


 


This license
agreement (the “Agreement”) is entered into by The Regents of the University of
California (“The Regents”), Department of Energy contract-operators of the
Ernest Orlando Lawrence Berkeley National Laboratory, 1 Cyclotron Road,
Berkeley, CA 94720, (jointly, “Berkeley Lab”), and Berkeley Heartlab, Inc.,
a California corporation (“HeartLab”) having its principal place of business at
1875 South Grant Ave, Suite 700, San Mateo, CA 94402.


 


1.  BACKGROUND


 


1.1           Certain inventions, generally characterized as measurement of
lipoprotein subspecies (Berkeley Lab reference number IB-1054), (the “Invention”),
were made in the course of research at Berkeley Lab and are covered by a U.S.
patent application and other proprietary rights.


 


1.2           The United States Department of Energy (“DOE”) sponsored
development of the Invention under Contract DE-AC03-76SF00098 between DOE and
The Regents (the “DOE Contract”). 
Consequently, this Agreement and the resulting license are subject to
overriding obligations to the federal government pursuant to the provisions of
the applicable law or regulations.


 


1.3           Berkeley Lab wants the Invention developed and used to the
fullest extent so that the general public enjoys the benefits.


 


1.4           HeartLab wants to obtain certain rights from Berkeley Lab for
the commercial development, manufacture, use, and sale of the Invention.


 


1.5           HeartLab is a “small business firm” as defined at Section 2
of Public Law 85-536 (15 U.S.C. 632).


 


Therefore the parties agree
as follows:


 


2.  DEFINITIONS


 


2.1           “Affiliate” of a party means any entity that, directly or
indirectly, controls that party, is controlled by that party or is under common
control with that party; “control” for these purposes means the actual, present
capacity to elect a majority of the directors or other managing authority of
such entity.


 


2.2           “Alternative Methodology Product” means any product or
service of HeartLab that performs substantially similar functions to inventions
claimed in a Licensed Patent (whether more highly automated or not) and whose
use, approval by the Federal Drug Administration, or attractiveness to the
market depends at least in a material part on Proprietary Rights.  Nothing in this Agreement shall create any
Berkeley Lab ownership interest to such Alternative Methodology Products, but
such products are subject to royalties to the extent provided in Section 5.1.


 


2.3           ‘‘Effective Date” means
April 30, 1997.


 


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2.4           “Highly Inflationary Currency” means the currency of any
economy with a cumulative inflation rate of 100% or more over the most recent
three calendar years, as measured by consumer price indices published by the
International Monetary Fund (International Financial Statistics), Washington,
D.C.


 


2.5           “Licensed Method” means any method, procedure, process or
other subject matter whose use or practice would constitute, but for the
license Berkeley Lab grants to HeartLab under this Agreement, an infringement
of any claim in the Licensed Patents.


 


2.6           “Licensed Patent” means US Patent Application Serial Number
[***]; any corresponding foreign patent application or patent for which
HeartLab has met the requirements of Article 15; any division,
reexamination, continuation, continuation-in-part (excluding new matter
contained and claimed in that continuation-in-part),application of any of the
foregoing or of which such application is a successor; any patents issuing on
any of the foregoing, and all renewals, reissues and extensions thereof.


 


2.7           “Licensed Product” means any product or service that employs
or is produced by the practice of inventions claimed in a Licensed Patent and
whose manufacture, use or sale would constitute, but for the license Berkeley
Lab grants to HeartLab under this Agreement, an infringement of any Valid Claim
in the Licensed Patents.


 


2.8           “Proprietary Rights” means information related to the
Invention, including data, drawings and sketches, designs, test results, and
information of a like nature, whether patentable or not, developed by [***] or
others working under their direct supervision at Ernest Orlando Lawrence
Berkeley National Laboratory. 
Proprietary Rights also includes copyright in the foregoing, to the
extent Berkeley Lab obtains the right to assert copyright under its DOE
Contract.


 


2.9           “Selling Price” for the purpose of computing royalties means [***]


 


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2.10         “Valid Claim” means either (a) a claim in a pending
patent application that has not been pending for more than four (4) years from
its filing date and that has not been abandoned; or (b) a claim of an
issued and unexpired patent that has not been held unenforceable, unpatentable
or invalid by a decision of a court or government agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal and
that has not been admitted by the holder of the patent to be invalid or unenforceable
through reissue, disclaimer or otherwise.


 


3.  LICENSE GRANT


 


3.1           Subject to the limitations set forth in this Agreement,
Berkeley Lab grants to HeartLab the limited (by the terms of Sections 3.2
and 3.7) exclusive, royalty-bearing license, under the Licensed Patents and
Proprietary Rights, to make, use, and sell Licensed Products and Alternative
Methodology Products and to practice Licensed Methods.


 


3.2           Any license under this Agreement is subject to the
following:  (a) DOE’s royalty-free
license for federal government practice only, and (b) DOE’s option to
grant licenses either if reasonable steps to commercialize the Invention are
not carried out or in order to meet federal regulations.  HeartLab shall use commercially reasonable
best efforts to commercialize Licensed Products.


 


3.3           Berkeley Lab also grants to HeartLab the right to issue
royalty-bearing sublicenses to make, use, and sell Licensed Products,
Alternative Methodology Products or to practice Licensed Methods; provided,
however, that HeartLab may issue such sublicenses only if HeartLab has current
exclusive rights under this Agreement.


 


3.4           Any sublicense HeartLab grants must be consistent with all
the rights and obligations due Berkeley Lab and the United States Government
under this Agreement, including, without limitation, the license back to the
United States Government.


 


3.5           HeartLab shall provide Berkeley Lab with a copy of each
sublicense issued under this Agreement; collect payment of all royalties due
Berkeley Lab from sublicensees; and summarize and deliver all reports due
Berkeley Lab from sublicensees under Article 7 (PROGRESS AND ROYALTY
REPORTS).


 


3.6           If this Agreement terminates for any reason, Berkeley Lab, at
its sole discretion, shall determine whether HeartLab must cancel or assign to
Berkeley Lab any or all sublicenses.


 


3.7           Berkeley Lab expressly reserves the right to use the
Invention and associated technology solely for noncommercial educational and
research purposes.


 


4.  LICENSE ISSUE FEE


 


4.1           HeartLab shall pay Berkeley Lab a license issue fee of [***]
payable as follows:  (a) [***]
within [***]; (b) an additional [***]
by [***]


 


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[***] indicates material that has been omitted
pursuant to a request for confidential treatment. The omitted material has been
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; (c) and the remaining [***] by [***].


 


4.2           This fee is non-refundable and is not an advance against
royalties.


 


5.  ROYALTIES AND PAYMENTS


 


5.1           HeartLab shall pay to Berkeley Lab an earned royalty of [***]
of the Selling Price of each Licensed Product HeartLab sells.  That [***] royalty represents a royalty of
[***] of Selling Price for the license of Licensed Patents and [***] of Selling
Price for the license of Proprietary Rights. 
The parties understand that the [***] royalty rate only applies to sales
in countries where there is a Valid Claim in the Licensed Patents that claims
the manufacture, use or sale of the Licensed Product; in all other countries,
the [***] royalty rate applies.  In
addition, HeartLab shall pay to Berkeley Lab an earned royalty of [***] of the
Selling Price of each Alternate Methodology Product HeartLab or its sublicensee
or Affiliate sell.


 


5.2           Under this Agreement a Licensed Product is considered to be
sold when reimbursed, or if not invoiced, when delivered to a third party.  But when the last patent covering a Licensed
Product expires or when the license terminates, any shipment made on or before
the day of that expiration or termination that has not been billed out before
is considered as sold (and therefore subject to royalty).  Berkeley Lab shall credit royalties that
HeartLab pays on a Licensed Product that the customer later rejects, returns or
does not accept.


 


5.3           For each sublicense, HeartLab shall pay Berkeley Lab the same
royalties it would pay if HeartLab was making, using, or selling Licensed
Products under this Agreement.  The
royalties paid to HeartLab may exceed the royalties paid to Berkeley Lab.


 


5.4           HeartLab shall pay to Berkeley Lab by August 31 of each
year the difference between the earned royalties for that calendar year already
paid to Berkeley Lab and the minimum annual royalty set forth in the following
schedule.  Berkeley Lab shall credit that
minimum annual royalty paid against the earned royalty due and owing for the
calendar year in which HeartLab made the minimum payment.


 


	
  Calendar Year

  	
   

  	
  Minimum Annual Royalty

  	
   

  
	
  1997

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  1998

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  1999

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  2000 and each year thereafter

  	
   

  	
  $

  	
  [***]

  	
   

  



 


If HeartLab’s rights convert to non-exclusive, the
minimum annual royalty amounts set forth in this Section 5.4 shall [***].


 


5.5           HeartLab shall send payment for royalties accruing to
Berkeley Lab quarterly together with its royalty report under
paragraph 7.4.


 


5.6           HeartLab shall make checks payable to “The Regents of the
University of California (Berkeley Lab/L-97-1203).”  HeartLab shall pay Berkeley Lab only in
United States dollars.  If a Licensed
Product is sold for moneys other than United States dollars (not including
Highly Inflationary Currency), HeartLab shall first determine the earned roy-


 


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alties in the foreign currency of
the country in which the Licensed Product was sold and then convert them into
equivalent United States dollars at the closing exchange rate published by The Wall Street Journal on the last
business day of the reporting period.  If
a Licensed Product is sold for a Highly Inflationary Currency, HeartLab shall
convert the sales subject to royalties into equivalent United States funds
using the closing exchange rates in effect on the date of invoicing (or if no
invoicing, of delivery) as published by The
Wall Street Journal.  HeartLab
shall quote the exchange rate in the Continental method (local currency per
U.S. dollar).


 


5.7           HeartLab may not reduce royalties payable by any taxes, fees,
or other charges imposed on the remittance of royalty income, except for
applicable withholding taxes imposed for Berkeley Lab’s account, if any.
HeartLab is also responsible for all bank transfer charges.


 


5.8           If HeartLab cannot promptly remit any royalties for sales in
any country where a Licensed Product is sold because of legal restrictions,
HeartLab may deposit in United States funds royalties due Berkeley Lab to
Berkeley Lab’s account in a bank or other depository in that country.  If HeartLab is not permitted to deposit those
payments in U.S. funds under the laws of that country, HeartLab may deposit
those payments in the local currency to Berkeley Lab’s account in a bank or
other depository in that country.


 


5.9           If a court of competent jurisdiction and last resort holds
invalid any patent or any of the patent claims within Berkeley Lab’s Patent
Rights in a final decision from which no appeal has or can be taken, HeartLab’s
obligation to pay royalties based on that patent or claim will cease as of the
date of that final decision.  HeartLab,
however, shall pay any royalties that accrued before that decision or that are
based on another patent or claim not involved in that decision or that are
based on Proprietary Rights.


 


5.10         HeartLab has no duty to pay Berkeley Lab royalties under this
Agreement on a Licensed Product HeartLab sells to the United States Government
including any United States Government agency. 
HeartLab shall reduce the amount charged for a Licensed Product sold to
the United States Government by an amount equal to the royalty otherwise due
Berkeley Lab.


 


6.  PERFORMANCE REQUIREMENTS


 


6.1           HeartLab shall diligently proceed with the development,
manufacture and sale of Licensed Products and/or Alternate Methodology Products
and shall diligently endeavor to market them within a reasonable time after the
Effective Date in quantities sufficient to meet the market demand.


 


6.2           HeartLab shall make commercially reasonable efforts to obtain
all necessary governmental approvals for the manufacture, use and sale of
Licensed Products and/or Alternate Methodology Products.


 


6.3           HeartLab is entitled to exercise prudent and reasonable
business judgment in meeting its performance requirements under this Agreement.


 


6.4           Subject to Section 6.3, if HeartLab is unable to perform
any of the following, then Berkeley Lab upon 60 days notice may either
terminate this Agreement or reduce this


 


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limited exclusive license to a
nonexclusive license, which is Berkeley Lab’s sole and exclusive remedy for
such failure:


 


[***]


 


6.5           If Berkeley Lab has the right under Section 6.4 and
grants a non-exclusive license to any other party upon royalty rates more
favorable than those of this Agreement after reducing this license to a
non-exclusive license, then [***]


 


6.6           HeartLab and Berkeley Lab by mutual written consent may amend
or extend the requirements of paragraph 6.4.1 at the written request of
HeartLab in response to legitimate business reasons, including changes in
regulatory requirements, market conditions, or other reasonably unforseeable
circumstances.


 


7.  PROGRESS AND ROYALTY REPORTS


 


7.1           Beginning November 30, 1997 and semi-annually
thereafter, HeartLab shall submit to Berkeley Lab a summary progress report
covering HeartLab’s activities related to the development and testing of all
Licensed Products and/or Alternate Methodology Products.


 


7.2           The progress reports HeartLab submits under
Paragraph 7.1 must include, but not be limited to, the following topics:


 


7.2.1        market plans for introduction of new Licensed Products and
Alternate Methodology Products; and


 


7.2.2        number of full-time equivalent (FTEs) employees or agents
working on the development or marketing of Licensed Products and/or Alternate
Methodology Products.


 


7.3           HeartLab shall also report to Berkeley Lab in its immediately
subsequent royalty report on the date of first commercial sale of each Licensed
Product and/or Alternate Methodology Products in the U.S. and in each other
country.


 


7.4           After the first commercial sale of a Licensed Product and/or
Alternate Methodology Products anywhere in the world, HeartLab shall make
quarterly royalty reports to Berkeley Lab on or before February 28, May 31,
August 31 and November 30 of each year.  Each royalty report must cover the most
recently completed calendar quarter and must show:


 


7.4.1        the Selling Price of each type of Licensed Product and/or
Alternate Methodology Products sold by HeartLab;


 


7.4.2        the number of each type of Licensed Product and/or Alternate
Methodology Products sold;


 


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7.4.3        the royalties, in U.S. dollars, payable under this Agreement
on those sales;


 


7.4.4        the exchange rates used in calculating the royalty due;


 


7.4.5        the royalties on government sales that otherwise would have
been due under Paragraph 5.10; and


 


7.4.6        for each sublicense, if any:


 


(1)           the sublicensee;


 


(2)           the number, description, and aggregate Selling Prices of
Licensed Products that the sublicensee sold or otherwise disposed of;


 


(3)           the exchange rates used in calculating the royalties due Berkeley
Lab from the sublicensee’s sales.


 


7.5           If no sales of Licensed
Products have been made during any reporting period, HeartLab shall make a
statement to this effect.


 


8.  BOOKS AND RECORDS


 


8.1           HeartLab shall keep books and records accurately showing all
Licensed Products manufactured, used, or sold under the terms of this
Agreement.  HeartLab shall preserve those
books and records for at least five years from the date of the royalty payment
to which they pertain and shall open them to inspection by representatives or
agents of Berkeley Lab at reasonable times.


 


8.2           Berkeley Lab shall bear the fees and expenses of Berkeley Lab’s
representatives performing the examination of the books and records.  But if the representatives discover an error
in royalties of more than 5% of the total royalties due for any year, then
HeartLab shall bear the fees and expenses of these representatives and the
difference between the earned royalties and the reported royalties (which shall
be subject to the provisions of Article 20 (LATE PAYMENTS)).


 


9.  LIFE OF THE AGREEMENT


 


9.1           Unless otherwise terminated by operation of law or by acts of
the parties in accordance with the terms of this Agreement, this Agreement
commences on the Effective Date and expires concurrently with the
last-to-expire issued Licensed Patent, or if no such Licensed Patent issues, at
ten (10) years from the Effective Date.


 


9.2           Any termination of this Agreement shall not affect the rights
and obligations set forth in the following Articles:


 


Article 8              Books and Records


 


Article 12            Disposition of Licensed
Products on Hand upon Termination


 


Article 13            Use of Names and Trademarks
and Nondisclosure of Agreement


 


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Article 19            Indemnification


 


Article 25            Export Control Laws


 


9.3           Termination does not affect in any manner any rights of
Berkeley Lab arising under this Agreement before the termination. After
expiration of the Agreement as provided in  9.1, HeartLab shall retain a
nonexclusive, royalty-free license under the Proprietary Rights for all
purposes.


 


10.  TERMINATION BY BERKELEY LAB


 


10.1         If HeartLab violates or fails to perform any material term of
this Agreement, then Berkeley Lab may give written notice of such default
(“Default Notice”) to HeartLab. 
If HeartLab fails to cure that default and provide Berkeley Lab with
tangible evidence of the cure within [***] days of the Default Notice, Berkeley
Lab may terminate this Agreement and the licenses granted by a second written
notice (“Termination Notice”) to HeartLab. 
If Berkeley Lab sends a Termination Notice to HeartLab, this Agreement
automatically terminates on the effective date of the Termination Notice.


 


11.  TERMINATION BY HEARTLAB


 


11.1         HeartLab at any time may terminate this Agreement in whole or
as to any portion of the Licensed Patents or Proprietary Rights by giving
written notice to Berkeley Lab. 
HeartLab’s termination of this Agreement will be
effective [***] days after its notice.


 


12.  DISPOSITION OF LICENSED PRODUCTS

ON HAND UPON TERMINATION


 


12.1         Within [***] days
of termination of this Agreement for any reason, HeartLab shall
provide Berkeley Lab with a written inventory of all Licensed Products in
process of manufacture or in stock. 
HeartLab shall dispose of those Licensed Products within [***] days of
termination.  The sale of any Licensed
Product within the [***] days is subject to the terms of this Agreement.


 


13.  USE OF NAMES AND TRADEMARKS AND

NONDISCLOSURE OF AGREEMENT


 


13.1         In accordance with California Education Code Section 92000,
HeartLab shall not use the name, “University of California, Ernest Orlando
Lawrence Berkeley National Laboratory, Department of Energy National Laboratory”
or shortened forms or adaptations of it (the “UC Name”), or make reference or
allusion to it in any advertisement, labeling or publicity relating to a
Licensed Product, except with the prior written permission of Berkeley Lab.


 


13.2         Neither party may disclose the terms of this Agreement to a
third party without express written permission of the other party, except when
required under either the California Public Records Act or other applicable law
or court order.  Notwithstanding the
foregoing, Berkeley Lab may disclose the existence of this Agreement and the
extent of the grant in Article 3, but shall not otherwise disclose the
terms of this Agreement, except to the DOE, and HeartLab may disclose the
Agreement in confidence to bona fide potential investors or acquirers.


 


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14.  LIMITED WARRANTY


 


14.1         Berkeley Lab warrants to HeartLab that it has the lawful
right to grant this license.


 


14.2         This license and the associated Invention are provided
WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY
OTHER WARRANTY, EXPRESS OR IMPLIED. BERKELEY LAB MAKES NO REPRESENTATION OR
WARRANTY THAT LICENSED PRODUCTS OR LICENSED METHODS WILL NOT INFRINGE ANY
PATENT OR OTHER PROPRIETARY RIGHT.


 


14.3         IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY
INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS
LICENSE OR THE USE OF THE INVENTION OR LICENSED PRODUCTS.


 


14.4         Nothing in this Agreement may be construed as:


 


	
  14.4.1

  	
  a
  warranty or representation by Berkeley Lab as to the validity or scope of any
  of Berkeley Lab’s rights in Licensed Patents;

  
	
   

  	
   

  
	
  14.4.2

  	
  a
  warranty or representation that anything made, used, sold or otherwise
  disposed of under any license granted in this Agreement is or will be free
  from infringement of patents of third parties;

  
	
   

  	
   

  
	
  14.4.3

  	
  an
  obligation to bring or prosecute actions or suits against third parties for patent
  infringement, except as specifically provided for in Article 16 (Patent
  Infringement); or

  
	
   

  	
   

  
	
  14.4.4

  	
  a grant
  by implication, estoppel or otherwise of any license or rights under any
  patents of Berkeley Lab other than Licensed Patents, regardless of whether
  such patents are dominant or subordinate to Licensed Patents;

  
	
   

  	
   

  
	
  14.4.5

  	
  an
  obligation to furnish any know-how not provided in Licensed Patents other
  than Proprietary Rights existing on the Effective Date.

  



 


15.  PATENT PROSECUTION AND MAINTENANCE


 


15.1         Berkeley Lab shall diligently maintain the United States
patents for Licensed Patents using counsel of its choice.  Berkeley Lab shall bear the cost of
preparing, filing, prosecuting and maintaining any United States patent covered
by this Agreement.


 


15.2         HeartLab may request that Berkeley Lab seek patent protection
on the Invention in foreign countries if available.  Berkeley Lab has no obligation to take action
to file foreign patent applications on behalf of HeartLab until the following
occurs:


 


	
  15.2.1

  	
  HeartLab
  makes that request in writing to Berkeley Lab by May 1, 1997. The
  absence of the required notice from HeartLab to Berkeley Lab acts as an
  election not to secure foreign rights.

  
	
   

  	
   

  
	
  15.2.2

  	
  That
  notice also identifies the countries HeartLab desires.

  



 


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  15.2.3

  	
  HeartLab
  pays Berkeley Lab the foreign license fee as set forth in
  paragraph 15.3.

  



 


15.3         The foreign license fee for each foreign counterpart to a
United States patent application shall be as follows:


 


	
  [***]

  	
   

  



 


15.4         Berkeley Lab shall bear the expense of preparing, filing and
prosecuting all foreign patent applications that Berkeley Lab files at
HeartLab’s request.  HeartLab shall bear
the expense of maintaining all resulting patents.  Berkeley Lab will hold those patents in its
name and obtain them using counsel of its choice.


 


15.5         Berkeley Lab may file patent applications at its own expense
in any country in which HeartLab has not elected to secure patent rights.  Those applications and resultant patents
shall not be subject to this Agreement.


 


15.6         Berkeley Lab shall provide HeartLab in a timely fashion with
copies of all relevant documentation so that HeartLab is informed of the
continuing prosecution of Licensed Patents and any foreign patent applications
Berkeley Lab files under paragraph 15.2 and has the opportunity to make
suggestions regarding such prosecution. 
HeartLab shall keep this documentation confidential. Berkeley Lab shall
use all reasonable efforts to amend any patent application to include claims
reasonably requested by Heart-Lab to protect the products contemplated to be
sold under this Agreement.


 


16.  PATENT INFRINGEMENT


 


16.1         If HeartLab learns of the substantial infringement of any of
Berkeley Lab’s Patent Rights, HeartLab shall so inform Berkeley Lab in writing
and shall provide Berkeley Lab with reasonable evidence of the
infringement.  During the period and in a
jurisdiction where HeartLab has exclusive rights under this Agreement, neither
party may notify a third party of the infringement of any of Berkeley Lab’s
Patent Rights without first obtaining written consent of the other party, which
consent shall not be unreasonably denied. 
Both parties shall use their best efforts in cooperation with each other
to terminate such infringement without litigation.


 


16.2         HeartLab may request that Berkeley Lab take legal action
against the infringement of Berkeley Lab’s Patent Rights.  HeartLab shall make that request in writing
and include reasonable evidence of the infringement and damages to
HeartLab.  If the infringing activity has
not been abated within [***] days of that request, Berkeley Lab may elect
to:  (a) commence suit on its own
account; or (b) refuse to participate in the suit. Berkeley Lab 


 


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[***] indicates material that has been omitted
pursuant to a request for confidential treatment. The omitted material has been
filed separately with the Securities and Exchange Commission.


 


10

















 


L-97-1203


 


 


shall give written notice of its
election to HeartLab by [***] after receiving notice of the request from
HeartLab. HeartLab may thereafter bring suit for patent infringement only if
Berkeley Lab elects not to commence suit and if the infringement occurred
during the period and in a jurisdiction where HeartLab has exclusive rights
under this Agreement.  If, however,
HeartLab elects to bring suit in accordance with this paragraph, Berkeley Lab
may thereafter join such suit at its own expense.


 


16.3         Such legal action as is decided upon must be at the expense
of the party on account of whom suit is brought and all consequent recoveries
belong to that party. But if Berkeley Lab and HeartLab jointly bring legal
action and fully participate in it, the parties must jointly share both the
expense and all recoveries in proportion to the share of expense each party
pays.


 


16.4         Each party shall cooperate with the other in litigation
proceedings instituted under this Agreement but at the expense of the party on
account of whom suit is brought.  The
party bringing the suit will control that litigation, except that Berkeley Lab
may elect to be represented by counsel of its choice in any suit brought by
HeartLab.


 


17.  WAIVER


 


17.1         The waiver of any breach of any term of this Agreement does
not waive any other breach of that or any other term.


 


18.  ASSIGNMENT


 


18.1         This Agreement is binding upon and
shall inure to the benefit of Berkeley Lab, its successors and assigns.  HeartLab may assign this Agreement upon
notice to Berkeley Lab to a HeartLab Affiliate or to a successor in interest by
way of acquisition, merger or sale of all or substantially all of HeartLab’s
assets.  Any other attempt by HeartLab to
assign this Agreement is void unless HeartLab obtains the prior written consent
of Berkeley Lab; Berkeley Lab shall not unreasonably withhold that consent.


 


19.  INDEMNIFICATION


 


19.1         HeartLab agrees to indemnify, hold harmless and defend
Berkeley Lab, its officers, employees, and agents; the sponsors of the research
that led to the Invention; and the inventors of the patents and patent
applications in Licensed Patents and their employers against any and all
claims, suits, losses, damage, costs, fees, and expenses resulting from or
arising out of exercise of this license or any sublicense except to the degree
attributable to Berkeley Lab’s own negligence or willful misconduct.  HeartLab shall pay all costs incurred by
Berkeley Lab in enforcing this indemnification, including reasonable attorney
fees.


 


19.2         HeartLab, at its sole expense, shall insure its activities in
connection with the work under this Agreement and obtain and keep in force
Comprehensive or Commercial Form General Liability Insurance (contractual
liability and products liability included) with limits as follows:


 


	
  19.2.1

  	
  Each
  Occurrence

  	
   

  	
  $

  	
  [***]

  
	
  19.2.2

  	
  Products/Completed
  Operations Aggregate

  	
   

  	
  $

  	
  [***]

  



 


4/29/97;
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[***] indicates material that has been omitted
pursuant to a request for confidential treatment. The omitted material has been
filed separately with the Securities and Exchange Commission.


 


11

















 


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  19.2.3

  	
  Personal
  and Advertising Injury

  	
   

  	
  $

  	
  [***]

  
	
  19.2.4

  	
  General
  Aggregate (commercial form only)

  	
   

  	
  $

  	
  [***]

  



 


19.3         The coverages and limits referred to in this Article 19
do not in any way limit the liability of HeartLab. HeartLab shall furnish
Berkeley Lab with certificates of insurance, including renewals, evidencing
compliance with all requirements at least 30 days prior to the first commercial
sale, use or distribution of a Licensed Product or Licensed Method.


 


	
  19.3.1

  	
  If such
  insurance is written on a claims-made form, coverage shall provide for a
  retroactive date of placement on or before the Effective Date.

  
	
   

  	
   

  
	
  19.3.2

  	
  HeartLab
  shall maintain the general liability insurance specified during: (a) the
  period that the Licensed Product or Method is being commercially distributed
  or sold (other than for the purpose of obtaining regulatory approvals) by
  HeartLab or by a sublicensee, Affiliate, or agent of HeartLab, and (b) a
  reasonable period thereafter, but in no event less than five years.

  



 


19.4         The insurance coverage of paragraph 19.2 must:


 


	
  19.4.1

  	
  Indicate
  that DOE, “The Regents of the University of California” and its officers,
  employees, students, and agents, are endorsed as additional insureds.

  
	
   

  	
   

  
	
  19.4.2

  	
  Include a
  provision that the coverages are primary and do not participate with, nor are
  excess over, any valid and collectible insurance or program of self-insurance
  carried or maintained by Berkeley Lab.

  



 


20.  LATE PAYMENTS


 


20.1         If HeartLab is late in making a payment to Berkeley Lab by
more than [***] after the payment is due, HeartLab shall pay to Berkeley Lab
such reasonable administrative fees and interest as Berkeley Lab
generally charges third parties on overdue accounts.


 


21.  NOTICES


 


21.1         Any payment, notice or other communication this Agreement
requires or permits either party to give must be in writing to the appropriate
address given below, or to such other address as one party designates by
written notice to the other party.  The
parties deem payment, notice or other communication to have been properly given
and to be effective (a) on the date of delivery if delivered in person; (b) on
the fourth day after mailing if mailed by first-class mail, postage paid; (c) on
the second day after delivery to an overnight courier service such as Federal
Express, if sent by such a service; or (d) upon confirmed transmission by
telecopier.  The parties’ addresses are
as follows:


 


4/29/97;
TTD/VW


 


[***] indicates material that has been omitted pursuant
to a request for confidential treatment. The omitted material has been filed
separately with the Securities and Exchange Commission.


 


12

















 


L-97-1203


 


 


	
  For payments to Berkeley Lab:

  

  Ernest O. Lawrence

  Berkeley National
  Laboratory

  Accounting/Financial Management

  P.O. Box 528

  Berkeley, California 94701

  Attention: Licensing
  Accountant

  Fax: 510/486-5995

  Telephone: 510/486-7113

  	
   

  	
  For all other notices to Berkeley Lab:

  

  Ernest O. Lawrence

     Berkeley National Laboratory

  Technology Transfer Department

  Mailstop 90-1070

  One Cyclotron Road
 Berkeley, California 94720

  Attention: Licensing Manager

  Fax: 510/486-6457

  Telephone: 510/486-6467

  
	
   

  	
   

  	
   

  
	
  In the case of HeartLab:

  

  1875 South Grant Ave, Suite 700

  San Mateo, CA 94402

  Attention: Dr. Robert Swift, CEO

  Fax: 415/372-1948

  Telephone: 415/372-1941

  	
   

  	
   

  



 


22.  U.S. MANUFACTURE


 


22.1         HeartLab
shall have Licensed Products produced for sale in the United States
manufactured substantially in the United States so long as HeartLab has current
exclusive rights.


 


23.  PATENT MARKING


 


23.1         HeartLab
shall mark all Licensed Products made, used or sold under this Agreement, or
their containers, in accordance with the applicable patent marking laws.


 


24.  GOVERNMENT APPROVAL OR REGISTRATION


 


24.1         If the law of any nation requires that any governmental
agency either approve or register this Agreement or any associated transaction,
HeartLab shall assume all legal obligation to do so.  HeartLab shall notify Berkeley Lab if it
becomes aware that this Agreement is subject to a U.S. or foreign government
reporting or approval requirement. 
HeartLab shall make all necessary filings and pay all costs, including
fees, penalties, and all other costs associated with such reporting or approval
process.


 


25.  EXPORT CONTROL LAWS


 


25.1         HeartLab shall observe all applicable United States and
foreign laws and regulations with respect to the transfer of Licensed Products
and related technical data, including, without limitation, the International
Traffic in Arms Regulations (ITAR) and the Export Administration Regulations.


 


4/29/97;
TTD/VW


 


[***] indicates material that has been omitted
pursuant to a request for confidential treatment. The omitted material has been
filed separately with the Securities and Exchange Commission.


 


13

















 


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26.  FORCE MAJEURE


 


26.1         If a party’s performance required under this Agreement is
rendered impossible or unfeasible due to any catastrophes or other major events
beyond its reasonable control, including, without limitation, the following,
the parties are excused from performance: 
war, riot, and insurrection; laws, proclamations, edicts, ordinances or
regulations; strikes, lockouts or other serious labor disputes; and floods, fires,
explosions, or other natural disasters. 
When such events abate, the parties’ respective obligations under this
Agreement must resume.


 


27.  MISCELLANEOUS


 


27.1         The headings of the several sections 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.


 


27.2         This Agreement is not binding upon the parties until it is
signed below on behalf of each party.


 


27.3         No amendment or modification hereof shall be valid or binding
upon the parties unless made in writing and signed on behalf of each party.


 


27.4         This Agreement embodies the entire and final understanding of
the parties on this subject. It supersedes any previous representations,
agreements, or understandings, whether oral or written.


 


27.5         If a court of competent jurisdiction holds any provision of
this Agreement invalid, illegal or unenforceable in any respect, this Agreement
must be construed as if that invalid or illegal or unenforceable provision is
severed from the Agreement.  All other
provisions of this Agreement must continue without regard to the severed
provision, provided that the remaining provisions of the Agreement are in
accordance with the intention of the parties.


 


27.6         This Agreement must be interpreted under California law.


 


Berkeley Lab and HeartLab
execute this Agreement in duplicate originals through their duly authorized
respective officers in one or more counterparts, that taken together, are but
one instrument.


 


	
  THE REGENTS OF THE UNIVERSITY
  OF CALIFORNIA, THROUGH THE ERNEST ORLANDO LAWRENCE BERKELEY NATIONAL
  LABORATORY

  	
   

  	
  BERKELEY HEARTLAB, INC.

  
	
   

  	
   

  	
   

  
	
  By 

  	
  /s/ Piermaria Oddone

  	
   

  	
  By 

  	
  /s/ Robert L. Swift

  
	
   

  	
  (Signature)

  	
   

  	
   

  	
  (Signature)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By 

  	
  Piermaria Oddone

  	
   

  	
  By 

  	
  Robert Swift

  
	
   

  	
  (Please Print)

  	
   

  	
   

  	
  (Please Print}

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title

  	
  Deputy Laboratory Director

  	
   

  	
  Title

  	
  Chief Executive Officer

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date 

  	
  April 30/97

  	
   

  	
  Date

  	
  April 30, 97

  
	
   

  	
   

  	
   

  
	
  Approved as to form

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
                    /s/
  Glenn R. Woods

  	
   

  	
   

  
	
  GLENN R. WOODS

  	
   

  	
   

  
	
  LAWRENCE BERKELEY
  LABORATORY

  	
   

  	
   

  
									



 


4/29/97;
TTD/VW


 


[***] indicates material that has been omitted
pursuant to a request for confidential treatment. The omitted material has been
filed separately with the Securities and Exchange Commission.


 


14