Document:

Exhibit 10.26

 

 

BERKELEY HEARTLAB, INC. AND DIADEXUS, INC.

MASTER
SUPPLY AGREEMENT

 

This Master Supply
Agreement, dated as of November 1, 2007, by and between diaDexus, Inc.
(“diaDexus”) and Berkeley HeartLab, Inc. (“Lab”), sets forth the terms and
conditions upon which diaDexus will sell to Lab, and Lab will purchase, various
products (the “Agreement”).  The parties
agree as follows:

 

A.           In
consideration of Lab purchasing from diaDexus the products specified in the
attached Product Addendum (“Products”) during the term of this Agreement,
diaDexus agrees to sell Products to Lab at the purchase prices set forth in the
attached Product Addendum.  Lab shall use
Products solely for performing in vitro clinical diagnostic testing on human
blood samples (“Permitted Use”).

 

B.             The
parties hereto acknowledge that this Agreement, including the exhibit and
addendum attached hereto, sets forth the entire agreement and understanding of
the parties as to the subject matter hereof and supersedes all prior and
contemporaneous discussions, agreements, and writings with respect hereto with
respect to the subject matter hereof. 
All previous agreements between diaDexus and Lab and Lab’s subsidiaries
will terminate as of December 31, 2006, other than surviving clauses.

 

C.             The
term of the Agreement shall commence on January 1, 2007 and expire on September
30, 2008 (the “Term”), unless extended for an additional three (3) months
by mutual consent in writing or terminated earlier pursuant to Paragraph N or
P.  Expiration or termination of this
Agreement for any reason will not release a party from any obligation that has
accrued prior to the effective date of such expiration or termination.  Paragraphs B, C, E, Q, R, S, T, U, V, W, X
and DD shall survive expiration or termination of this Agreement.

 

D.            diaDexus
shall ship Product(s) to Lab which orders such Product(s) under a
purchase order and which is authorized by the parties under this
Agreement.  Invoices shall be mailed to
the following address:

 

Berkeley
HeartLab, Inc.

Accounts
Payable Department

839
Mitten Road

Burlingame,
CA 94010

 

E.              Lab
shall pay diaDexus within forty-five (45) days after such invoice is received
by Lab.  In addition, Lab shall pay to
diaDexus the [***], as defined in the Product Addendum, in accordance with the
Product Addendum.  All applicable sales
or use taxes are the responsibility of Lab. 
In those states where diaDexus collects local/state sales taxes,
diaDexus will add these taxes to the invoices and after receipt of payment from
Lab, diaDexus shall remit such amounts to the appropriate taxing
authority(ies).  Any payment due and
payable under the terms and conditions of this Agreement made after the date
such payment is due and payable shall bear interest as of the 45th
day after the date such payment was due and payable and shall continue to
accrue such interest until such payment is made at a rate equal to the lesser
of the prime rate as reported by the Chase Manhattan Bank, New York, New York,
on the date such payment is due, plus an additional two percent (2%), or the
maximum rate permitted by law in the State of California. All payments made
under this Agreement shall be made in U.S. dollars, and such payments shall be
made by check or wire transfer to one or more bank accounts to be designated in
writing by diaDexus.  If payments are not
made, then orders will be placed on credit hold.

 

Term: January
1, 2007 - September 30, 2008

 

BHL/diaDexus_070919

 

[***] 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.

 

1

 

F.              Product
shipment shall be made FOB diaDexus’ domestic supply source.  Products will be shipped to the following
address:

 

Berkeley HeartLab, Inc.

960 Atlantic Ave, Suite #100

Alameda, CA 94501

Attn:  Lab
Manager

510-263-4088

 

G.             Except
as expressly provided herein, neither this Agreement nor any interest hereunder
will be assignable, nor any other obligation delegable, by a party without the
prior written consent of the other, which shall not be unreasonably withheld or
delayed; provided, however, that either party may assign this Agreement without
consent to any successor in interest by way of merger or sale of all or
substantially all of its assets in a manner such that the assignor will remain
liable and responsible for the performance and observance of all such party’s
duties and obligations hereunder. Any purported assignments made in violation
of this Paragraph G shall be null and void.

 

H.            Notices
and other communications permitted or required under this Agreement will be
deemed to be properly given when received by the other party and if given in
writing and either delivered by hand, overnight delivery service, or mailed by
First Class U.S. Mail, postage prepaid, addressed to the applicable party
as follows:

 

	
  diaDexus:

  	
   

  	
  diaDexus, Inc.

  
	
   

  	
   

  	
  343
  Oyster Point Boulevard

  
	
   

  	
   

  	
  South San Francisco, CA
  94080-1913

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention:
  Patrick Plewman

  
	
   

  	
   

  	
  President
  and Chief Executive Officer

  
	
   

  	
   

  	
   

  
	
  Lab:

  	
   

  	
  Berkeley
  HeartLab, Inc.

  
	
   

  	
   

  	
  839 Mitten Road

  
	
   

  	
   

  	
  Burlingame, CA 94010

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention:

  	
  Michael Mercer

  
	
   

  	
   

  	
   

  	
  Chief Commercial Officer

  
	
   

  	
   

  	
   

  
	
  With a copy to:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Berkeley
  HeartLab, Inc.

  
	
   

  	
   

  	
  839 Mitten Road

  
	
   

  	
   

  	
  Burlingame, CA 94010

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention: General Counsel

  

 

I.                 Products
shall be supplied in accordance with a  specification
for identity and quality of the Product as set forth in the PLAC® test Gen3
product insert (the “Specification”). 
The Specifications are considered a performance guaranty and represent
the expectation for the Product’s performance by Lab.  diaDexus shall give Lab a 90-day written
notification of any changes to the Specification.

 

Prior to using a Product
with changes in Specifications, or offering to Lab, Products for the Permitted
Use, diaDexus will, at its sole cost and expense, complete a full method
validation, according to CLSI accepted guidelines and present such data to Lab
for consideration.  Lab may conduct further
validation in collaboration with diaDexus. 
diaDexus shall, at its expense, supply kits, technical services and
samples as reasonably required for such validation testing, and Lab shall
procure necessary equipment and reagents for such. Lab shall also assign
competent trained personnel appropriate for testing the Products.  Lab shall perform the validation testing and
share results and data (which shall be Confidential Information, subject to
Paragraph V) as necessary with diaDexus to ensure that all regulatory and
quality control requirements have been met to mutual satisfaction before
shipment of Product(s) for 

 

BHL/diaDexus_070919

 

[***] 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.

 

2

 

 

Permitted Use.  The performance of Product in the Lab will
ultimately determine the acceptability of Product.  Lab has the right to reject the changes if
Product’s performance is deemed not acceptable.

 

diaDexus will guarantee
to Lab overnight delivery. If a shipment is received in which the Product
appears to have warmed during shipment (indicated by the cold packs being
warm), Lab will test the shipment at its discretion and inform diaDexus.  In such a case, diaDexus will bear the cost
for the return shipment and replacement of such Product.

 

Prior to using a Product
with a new lot number, Lab will perform acceptability studies.  Lab will perform correlation, linearity and
precision studies to determine acceptability using Lab’s established procedures
for these studies.  For the correlation
studies, a minimum of 60 samples spanning the Lab’s assay range for the Product
will be tested in a controlled side-by-side study, minimizing lab and operator
variables, and the average bias between the new Product lot and the previous
Product lot will have to be less than 13%, supported by appropriate statistical
analysis in order to be acceptable by Lab. 
For any analysis that does not meet Lab’s expectations, that analysis
shall be shared with diaDexus. The results of the precision studies must be
<8% CV for “within run/intra-assay precision” and the results of the
linearity studies must meet Lab achieved linearity of <20% average bias for the
obtained values compared to the expected values up to a range of 100-360
ng/mL.  Lab shall inform diaDexus of the
result of the acceptance inspection including the judgment of acceptance or
rejection of all or part of a shipment in writing within ten (10) business
days after the receipt of such shipment of Product.  If Lab fails to notify diaDexus of a
rejection within such ten (10) business day period, the shipment of
Product shall be deemed accepted by Lab. 
For clarity, Lab shall have no right to reject any Product that is not
stored as required by the Specification during the thirty (30) day period
beginning upon Lab’s receipt of Product.

 

In the event that
diaDexus receives a notice of rejection from Lab in accordance with this
Paragraph I, diaDexus, shall use all best efforts to replace any shipment of
such rejected Product within fifteen (15) days  after
receiving Lab’s written notice of rejection. 
Lab shall keep such defective Products at its premises until the earlier
of (a) thirty (30) days or (b) receipt of diaDexus’ instruction for
return or disposal of such defective Products and shall return or dispose of
such defective Products in accordance with such instruction.  If Lab is instructed to (i) return such
defective Products, diaDexus shall assign Lab a return goods authorization
(RGA) number, shall provide shipping instructions for such return and shall
reimburse Lab for any reasonable freight charges associated with such return or
(ii) to dispose of such defective Products, diaDexus shall reimburse
Lab for any costs associated with such disposal.  Notwithstanding anything to the contrary,
diaDexus shall have no obligation to replace any shipment of Product pursuant
to this Paragraph I if such defect occurred after Lab’s receipt of such Product
from diaDexus, unless such defect is of a nature that could not be discovered
during Lab’s acceptability study (such defect shall be referred to as a “Latent
Defect”).  In the event of any Latent
Defect, Lab may revoke its acceptance of such defective Products by providing
written notice thereof to diaDexus within ten (10) days of discovering
such Latent Defect.  Notwithstanding
anything to the contrary in this Agreement, the parties acknowledge that
replacement of defective Products pursuant to this Paragraph I and
indemnification under and pursuant to Paragraph R shall be the sole and
exclusive remedy of Lab for any Product defects, including breach of the
warranty set forth in Paragraph Q.

 

If diaDexus disputes Lab’s right to reject any
shipment of Product as set forth in this Paragraph I, diaDexus shall notify Lab
within twenty (20) days after such rejection. 
Such dispute shall be resolved by a third party, the identity of whom
shall be mutually agreed upon by the parties, and the appointment of whom shall
not be unreasonably delayed by either party. 
The determination of such third party with respect to any shipment of
Product shall be final and binding upon the parties, but only as to the reasons
given by Lab in rejecting the shipment and shall have no effect on any matter
for which such third party did not make a determination.  The fees and expenses of such third party
shall be paid by the party against which the determination is made.

 

Lab shall reasonably
cooperate with diaDexus in the performance of periodic quality control surveys
as requested by diaDexus to ensure that Products are used for the Permitted Use
and meet regulatory requirements.  Lab
hereby agrees to discuss technical performance and collaboratively resolve any
problems with diaDexus technical support personnel, provided that all such
personnel execute reasonable non-disclosure and non-use agreements, as may be
requested by Lab.

 

diaDexus shall provide
competent trained personnel to assist Lab with Technical issues that may arise
from time to time and to address technical issues associated with performance
of the Product.

 

BHL/diaDexus_070919

 

[***] 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.

 

3

 

 

J.                Lab
will provide diaDexus with monthly testing volume reports sorted by [***] in
the Snapshot Report and the Final Report.

 

K.            This
Agreement may not be amended or modified except by written agreement of both of
the parties.

 

L.              diaDexus
will not be liable for any failure to perform under this Agreement due to
strikes, fire, explosion, flood, riot, lock-out, injunction, interruption of
transportation, unavoidable accidents, or inability to obtain supplies at
reasonable prices.

 

M.         In
the event that a Product is unavailable, diaDexus will notify Lab of such
unavailability by written or electronic communication, and diaDexus will,
within the course of fifteen (15) working days, notify Lab of an action plan to
correct the problem.

 

N.            This
Agreement may be terminated by either party with or without cause at any time
with ninety (90) days written notice.

 

O.            Items
defined as Products listed on the Product Addendum or added on the Product
Addendum at a later date will have guaranteed pricing through the term of the
Agreement.

 

P.              If
any term of this Agreement is breached materially by either party and the
parties cannot agree on a resolution, the non-breaching party may terminate
this Agreement if the breach is not cured within 30 days after notice is given
in accordance with Paragraph H.

 

Q.            diaDexus
represents and warrants to Lab that the Products supplied shall (i) not be
adulterated or misbranded by diaDexus within the meaning of the U.S. Food,
Drug, and Cosmetic Act; (ii) be produced in accordance with the U.S. Food,
Drug and Cosmetic Act Quality System Requirements, specifically 21 CFR Part 820;
and (iii) function in accordance with the Specifications supplied by
diaDexus in connection with such Products after inspection and acceptance by
Lab in accordance with Paragraph I; provided that Lab maintains and
stores such Products in accordance with instructions contained in such
documentation.  diaDexus hereby represents
and warrants that, to the best of its knowledge, the practice of any technology
or patents comprising the Product that are licensed hereunder is and will be
free of any infringement of patents of other persons.  EXCEPT AS SPECIFICALLY SET FORTH IN THIS
PARAGRAPH Q, DIADEXUS MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS
OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, ANY
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR USE, ANY WARRANTY OF
NON-INFRINGEMENT, ANY WARRANTY OF SAFETY, OR ANY OTHER STATUTORY WARRANTY.  IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR
INCIDENTAL, CONSEQUENTIAL, INDIRECT, PUNITIVE, EXEMPLARY, OR SPECIAL DAMAGES
INCURRED BY THE OTHER OR ANY AFFILIATE OR SUBSIDIARY ARISING OUT OF OR RELATED
TO THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.

 

R.             diaDexus
agrees to defend, indemnify, and hold Lab, directors, officers, employees, and
agents wholly harmless from and against third-party claims, losses, lawsuits,
settlements, demands, causes, judgments, expenses, and cost (including
reasonable attorney fees) arising under or in connection with this Agreement
(collectively, referred to as “Claims”) in the event that such Claims are
caused by a) diaDexus’ breach of any of its warranties in this Agreement, b)
the failure of Products to function properly for the Permitted Use by Lab under
this Agreement, c) any gross negligence or willful misconduct of diaDexus, or
d) any other liability resulting from Lab’s use of the Products within the
Permitted Use under this Agreement. 
However, the foregoing rights to indemnity shall not apply to the extent
that such Claims result from Lab’s negligence or willful misconduct, including,
without limitation, the negligence of Lab’s employees, or from the modification
of any Product of diaDexus by Lab or a third party not within diaDexus’s
control or without diaDexus’ express written permission.  The obligation of diaDexus to defend,
indemnify and hold harmless shall also include, but is not limited to, any such
third-party claims, losses, damages, lawsuits, settlements, demands, causes,
judgments, expenses and costs (including reasonable attorney fees) against Lab
which relate in any manner to Lab’s alleged infringement of any property rights
of a third party in or to the Product or licenses under this Agreement.

 

BHL/diaDexus_070919

 

[***] 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.

 

4

 

 

Lab agrees to defend,
indemnify, and hold diaDexus and subsidiaries, directors, officers, employees,
and agents wholly harmless from and against any and all Claims that arise from (i) the
willful misconduct of Lab including, without limitation, modification of any
Product of diaDexus by Lab or a third party not within diaDexus’ control or
without diaDexus’ express written permission; Lab’s gross negligence or willful
misconduct, including, without limitation, the gross negligence of Lab’s
employees.  However, the foregoing rights
to indemnity shall not apply to the extent that such Claims result from
diaDexus’ negligence or willful misconduct including, without limitation, the
negligence of diaDexus’ employees, or from the modification of any Product of
Lab by diaDexus or a third party at diaDexus’ instruction.

 

For purposes of this
Paragraph R, the indemnified party shall give prompt written notice to the
indemnifying party of any suits, claims, or demands by third parties or the
indemnified party that may give rise to any Claim for which indemnification may
be required under this Paragraph R; provided, however, that
failure to give such notice shall not relieve the indemnifying party of its
obligation to provide indemnification hereunder except if and to the extent
that such failure materially affects the ability of the indemnifying party to
defend the applicable Claim.

 

The indemnifying party
shall be entitled to assume the defense and control of any such Claim at its
own cost and expense; provided, however, that the indemnified
party shall have the right to be represented by its own counsel at its own cost
in such matters.  In the event that the
indemnifying party declines to or fails to timely assume control of any such
Claim, the indemnified party shall be entitled to assume such control, conduct
the defense of, and settle such Claim, all at the sole cost and expense of the
indemnifying party.

 

Neither the indemnifying
party nor the indemnified party shall settle or dispose of any Claim in any
manner that would adversely affect the rights or interests of the other party
without the prior written consent of the other party, which shall not be
unreasonably withheld or delayed.  Each
party shall cooperate with the other party and its counsel in the course of the
defense of any Claim, such cooperation to include without limitation using
reasonable efforts to provide or make available documents, information, and
witnesses

 

S.              diaDexus
shall, at its sole cost and expense, obtain and keep in force a policy of
comprehensive general liability insurance with bodily injury, death, and
property damage limits of One Million U.S. Dollars ($1,000,000) per occurrence
and Two Million U.S. Dollars ($2,000,000) in the aggregate and product
liability coverage insurance of One Million U.S. Dollars ($1,000,000) per
occurrence and One Million U.S. Dollars ($1,000,000) in aggregate.

 

T.             diaDexus
acknowledges that Lab has a proprietary interest in its legal and business name
and reputation.  Lab acknowledges that
diaDexus has a proprietary interest in its legal and business name and
reputation as well as the brand name and trademarks of its products.  Therefore, each party agrees that it shall
not use the other party’s name nor shall a party mention or describe this
Agreement or its relationship with the other party in any press release,
advertising, marketing, and promotional materials or other publications or
materials without first obtaining the prior written approval of the other
party.  Without limiting the foregoing,
diaDexus agrees not to use any name or mark of Lab or to quote the opinion of
any of Lab’s employees in any advertising or other publicity, including in
client lists or on diaDexus website, without obtaining the prior written
consent of Lab.

 

U.            Lab
shall label the Product as the PLAC® Test for Lp-PLA2, PLAC® Test,
or Lp-PLA2 on its test requisition order forms. 
If Lab wishes to market the diaDexus Product using the associated marks,
diaDexus hereby grants to Lab a non-exclusive, non-sublicensible license to use
its trademarks solely for the Permitted use.

 

V.             Audit
Rights; (a) Procedure.  Upon the
written request of diaDexus, and not more than once in each calendar year, Lab
will permit an independent auditing firm, e.g., Protiviti, selected by
diaDexus, and reasonably acceptable to Lab, at diaDexus’s expense, to have
access during normal business hours, and upon reasonable prior written notice,
to such of the records of Lab as may be reasonably necessary to verify the
accuracy of any financial information disclosed to diaDexus related to any
calendar quarter’s average net sales price within the preceding one (1) year
of that quarter’s final adjustment.  If
such firm concludes that additional payments were owed during such period, Lab
will pay the additional payments, with interest from the date originally due at
the prime rate, as published in The Wall Street Journal (Eastern U.S. Edition)
on the last business day preceding such date, within thirty (30) days after the
date such firm’s written report is delivered. 
If the amount of the underpayment is greater than five percent (5%) of
the total amount owed, then Lab will in addition reimburse diaDexus for its
reasonable costs related to such audit. (b) Confidentiality. The
independent auditing firm shall be required to maintain all information it
reviews in 

 

BHL/diaDexus_070919

 

[***] 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.

 

5

 

 

confidence, except
that it may report the summary balance of payment results of its audit to
diaDexus.  diaDexus will treat all
information subject to review under this Paragraph V in accordance with the
confidentiality provisions of Paragraph W, and will cause its firm to
enter into non-disclosure, non-use and Business Associate agreements reasonably
acceptable in form and substance to Lab, obligating such firm to retain all
such financial information in confidence and not otherwise use such information
pursuant to such confidentiality agreement. 
(c) Audit Disputes.  If Lab
in good faith disputes the conclusion of the firm under subsection (b) above
that Lab owes additional royalties or other payments, or any specific aspect of
the conclusion, then Lab will inform diaDexus by written notice within thirty
(30) days of receiving a copy of the audit containing such conclusion,
specifying in detail the reasons for Lab’s disputing such conclusion.  The parties will promptly thereafter meet and
negotiate in good faith a resolution to such dispute.  In the event that the parties are unable to
resolve such dispute within thirty (30) days after such notice, the matter will
be resolved pursuant to Paragraph X, and interest will be payable on any
additional payments determined to be due.

 

W.        The
parties have provided to each other prior to entering into this Agreement, and
in connection with this Agreement may in the future provide to each other,
confidential information, including but not limited to each party’s know-how,
invention disclosures, patent applications, proprietary materials and/or
technologies, economic information, business or research strategies, trade secrets,
and material embodiments thereof (“Confidential Information”).  The terms and conditions of this Agreement
shall be Confidential Information of the parties, and subject to the terms of
this Paragraph W.

 

The receiving party shall
maintain the Confidential Information of the disclosing party in confidence,
shall not disclose such Confidential Information to any third party, and shall
not use such Confidential Information for any purpose except as expressly
permitted under the terms and conditions of this Agreement.  Notwithstanding the previous sentence, the
receiving party may disclose the Confidential Information of the disclosing
party to its employees, agents, consultants, and professional, scientific, medical,
and legal advisors who have a need to know such Confidential Information; provided
that any such person to whom disclosure is made is bound by obligations of
non-disclosure and non-use no less restrictive then those set forth
herein.  The receiving party shall take
the same degree of care that such party uses to protect its own confidential
and proprietary information of a similar nature and importance, but in no event
shall such care be less than reasonable care.

 

The obligations of
non-disclosure and non-use under this Paragraph W will not apply as to
particular Confidential Information of a disclosing party to the extent that
such Confidential Information:  (a) is
at the time of receipt, or thereafter becomes, through no fault of the
receiving party, published or publicly known or available; (b) is known by
the receiving party at the time of receiving such information, as evidenced by
written records; (c) is hereafter furnished to the receiving party by a
third party without breach of a duty to the disclosing party; or (d) is
independently discovered or developed by the receiving party without use of,
application of, access to, or reference to Confidential Information of the
disclosing party as evidenced by written records. Both parties shall not,
directly or indirectly, (a) use the Confidential Information to guide or
aid a search and/or evaluation of publicly available information for purposes
of either showing the Confidential Information is in the public domain or to
recreate the knowledge or logic contained within the Confidential Information
from non-protected sources and/or (b) disassemble, reverse engineer or
otherwise use the Confidential Information as a guide or template to otherwise
recreate the logic or knowledge contained within the Confidential Information
and/or to directly or indirectly offer or use a product and/or service that
incorporates or uses the functionality of anything disclosed in the
Confidential Information or substantially equivalent to or substituting for,
any functionality disclosed by the other party in the Confidential Information
of such other party or for any other purpose.

 

Disclosure of
Confidential Information shall not be precluded if such disclosure (i) is
in response to a valid order of a court or other governmental body or (ii) is
required by law or regulation; provided, however, that the
receiving party shall first have given reasonable prior notice to the
disclosing party and shall have made a reasonable effort to obtain a protective
order, or to cooperate with the disclosing party’s efforts, as applicable, to
obtain a protective order limiting the extent of such disclosure and requiring
that the Confidential Information so disclosed be used only for the purposes
for which such order was issued or as required by such law or regulation.

 

The receiving party
agrees that its obligations under this Paragraph W are necessary and
reasonable to protect the disclosing party’s business interests and that the
unauthorized disclosure or use of Confidential Information of a disclosing
party will cause irreparable harm and significant injury, the degree of which
may be difficult to ascertain.  

 

BHL/diaDexus_070919

 

[***] 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.

 

6

 

The receiving party
further acknowledges and agrees that in the event of any actual or threatened
breach of this Paragraph W, the disclosing party may have no adequate remedy
at law and, accordingly, that the disclosing party will have the right to seek
an immediate injunction enjoining any breach or threatened breach of this
Paragraph W, as well as the right to pursue any and all other rights and
remedies available at law or in equity for such breach or threatened breach.

 

All obligations of
non-disclosure and non-use imposed pursuant to the terms and conditions of this
Paragraph W shall survive expiration or termination of this Agreement and
continue in full force and effect for a period of ten (10) years after the
effective date of such expiration or such termination.

 

X.            This Agreement is made in accordance with,
and this Agreement and any dispute arising out of, related to, or in connection
with this Agreement shall be governed and construed under, the laws of the
State of California, United States of
America, without giving effect to any choice of law principles that would
result in the application of the laws of any State other than the State of California.  Any
claim, dispute, or controversy arising out of or in connection with this
Agreement or the breach or alleged breach of this Agreement shall be submitted
for adjudication to the United States District Court, Northern District of California, or in the event that subject matter
jurisdiction does not exist in such Court, to the state court sitting within
the territory of the Northern District of California.  Each party hereby consents to personal
jurisdiction and venue in these courts.

 

Y.             The
relationship of the parties established by this Agreement is that of
independent contractors.  Nothing in this
Agreement shall be constructed to create any other relationship between the
parties.  Neither party shall have any
right, power, or authority to bind the other or assume, create, or incur any
expense, liability, or obligation, express or implied, on behalf of the other
party.  This Agreement is neither
expressly nor impliedly made for the benefit of any party other than those executing
it.

 

Z.             The
failure of a party to enforce any rights or provisions of the Agreement shall
not be construed to be a waiver of such rights or provisions, or a waiver by
such party to thereafter enforce such rights or provision or any other rights
or provisions hereunder.  No trade
customs, courses of dealing or courses of performance by the parties shall be
relevant to modify, supplement, or explain any term(s) used in this
Agreement.

 

	
  AA

  	
   

  	
  If any term, condition
  or provision of this Agreement is held to be unenforceable for any reason, it
  shall be interpreted to achieve the intent of the parties to this Agreement to the extent possible rather than
  voided. In any event, all other terms, conditions, and provisions of this
  Agreement shall be deemed valid and enforceable to the full extent.

  
	
   

  	
   

  	
   

  
	
  BB.

  	
   

  	
  Each party shall carry
  out its activities pursuant to this Agreement in compliance with all
  applicable federal, state, and local laws, rules, regulations, and
  guidelines.

  
	
   

  	
   

  	
   

  
	
  CC.

  	
   

  	
  Upon the execution of
  this Agreement, diaDexus shall simultaneously execute a Business Associate
  Agreement with Lab in a form substantially similar to the one attached hereto
  as Exhibit A.

  
	
   

  	
   

  	
   

  
	
  DD.

  	
   

  	
  This Agreement may be
  executed in counterparts, each of which shall be deemed an original and all
  of which together shall constitute one instrument.

  

 

BHL/diaDexus_070919

 

[***] 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.

 

7

 

 

	
  EE.

  	
   

  	
  To the extent that
  there is any conflict or inconsistency between this Agreement and any
  purchase order, the attached Product Addendum, or any other document
  pertaining to the supply of Product, the terms of this Agreement shall govern
  unless specifically acknowledged and agreed to in writing by each of the
  parties.

  

 

 

	
  Berkeley
  HeartLab, Inc.

  	
   

  	
  diaDexus, Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:
  

  	
        /s/
  Frank Ruderman

  	
   

  	
  By:
  

  	
        /s/
  Patrick Plewman

  
	
   

  	
   

  	
   

  	
   

  
	
  Print
  Name: Frank Ruderman

  	
  Patrick
  Plewman

  
	
   

  	
   

  
	
  Title: President

  	
  Title:
  President & CEO

  
	
   

  	
   

  	
   

  
	
  Date: November 9,
  2007

  	
  Date:
  11/16/07

  
						

 

BHL/diaDexus_070919

 

[***] 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.

 

8

 

diaDexus -  Berkeley
HeartLab, Inc.

PRODUCT ADDENDUM

 

	
  Catalog #

  	
   

  	
  Description

  	
   

  	
  Lab Price

  
	
  90106

  	
   

  	
  GEN3 PLAC® Test Kit for
  Lp-PLA2 96-well microplate ELISA kit

  	
   

  	
  [***]

  
	
  90104

  	
   

  	
  GEN3 PLAC® Test
  Controls 2 controls, 1 vial each, 3 mL each

  	
   

  	
  [***]

  

 

Lab will issue a “snapshot”
sales report to diaDexus on or before the 10th calendar day of each
month for the prior month’s expected utilization of Product (the “Snapshot Report”),
delineating between patient reportable results and CRO results.  diaDexus will invoice Lab, using the Lab
Price schedule above, on the 10th calendar day of each month based
on Lab’s Snapshot Report of total Patient and total CRO results from the preceding
month.  Lab will provide a report by the
20th calendar day of each month for the immediate prior month’s
actual utilization of Product (the “Final Report”).  Any difference between the Snapshot Report
and the Final Report will be accounted for in the subsequent month’s
invoice.  For clarification and as an
example only: on or before the 10th calendar day of October, Lab
would issue a Snapshot Report for September’s expected utilization and diaDexus
would immediately invoice.  By October 20th,
Lab would issue a Final Report for September’s actual utilization and any
difference between the Snapshot and Final Reports would be accounted for in the
November 10th invoice.

 

Net Sales Reconciliation*

 

In addition to the
payments set forth above, the parties agree to have a [***], on a [***] basis,
based on the [***].  

 

Within one hundred
(100) calendar days after the end of each quarter, Lab will reconcile its
payments to diaDexus for the six month period that ends as of the last day of
such quarter (the “Measurement Period”) such that the total amount owed to
diaDexus by Lab for the PLAC test during the Measurement Period will equal the
equivalent of [***] by Lab during the same Measurement Period, including [***];
provided, however, in no event will Lab pay diaDexus less than [***].  If the [***] for the PLAC tests performed
should fall below [***], diaDexus and Lab will [***] on a go-forward
basis.  For example, if the [***] for the
PLAC tests performed the prior quarter is [***], then Lab will pay diaDexus an
additional [***] per each test performed in that quarter [***].

 

Notwithstanding the
foregoing, the first net sales reconciliation for the time period from January
1 through May 31, 2007 was delivered to diaDexus as of the date of this
Agreement and the second net sales reconciliation will be due no later than
October 31, 2007 and will cover the time period June 1 through June 30,
2007.  Subsequent net sales
reconciliations will be due as set forth above. 
diaDexus recognizes that [***] may not be resolved within 100 days from
end of quarter; accordingly [***] may require adjustment.  Subject to the Measurement Period limitation
set forth above, any such adjustments will be accounted for in the subsequent [***]
reconciliation and applied to the most recent outstanding invoice from
diaDexus; provided, however, no such adjustments will apply to the time period
prior to January 1, 2007.  All net sales
reconciliation amounts and reports provided to diaDexus shall be certified for
accuracy by a financial officer of Lab.

 

BHL/diaDexus_070919

 

[***] 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.

 

9

 

 

TERMS
AND CONDITIONS AS SET FORTH IN THE MASTER SUPPLY AGREEMENT

SHALL
APPLY TO THIS PRODUCT ADDENDUM

 

	
  Pricing
  Effective

  	
   

  	
  Expires

  
	
  Date:
  January 1, 2007

  	
   

  	
  Date:
  September 30, 2008

  
	
   

  	
   

  	
   

  
	
  Berkeley
  HeartLab, Inc.

  	
   

  	
  diaDexus, Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
    /s/  Frank
  Ruderman

  	
   

  	
  By:

  	
     /s/
  Patrick Plewman

  
					

 

	
  Print
  Name:

  	
  Frank
  Ruderman

  	
  Patrick
  Plewman

  
	
   

  	
   

  
	
  Title:

  	
  President

  	
  Title:
  President & CEO

  
	
   

  	
   

  
	
  Date:

  	
  November 9,
  2007

  	
  Date:

  	
   

  	
  11/16/07

  	
   

  

 

BHL/diaDexus_070919

 

[***] 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

 

EXHIBIT A

 

diaDexus-  Berkeley
Heart Lab, Inc.

Business Associate Agreement

 

This Business Associate
Agreement (“Agreement”) is entered into this 1st day of November 2007 (the
“Effective Date”) by and between Berkeley HeartLab, Inc., a California
corporation (“BHL”), and diaDexus, Inc., a Delaware corporation (“Contractor”).

 

RECITALS

 

A.            Pursuant to HIPAA, BHL, as a Covered Entity, as defined
in 45 C.F.R. §160.103, is required to enter into this Agreement to obtain
satisfactory assurances that Contractor, a Business Associate, will
appropriately safeguard all Protected Health Information disclosed, created or
received by Contractor on behalf of, BHL.

 

B.            BHL desires to engage Contractor to perform certain
functions for, or on behalf of, BHL involving the disclosure of PHI by BHL to
Contractor, or the creation or use of PHI by Contractor on behalf of BHL, and
Contractor desires to perform such functions.

 

C.            This contract shall be deemed an amendment to the parties’
Master Supply Agreement dated November 1, 2007 (“Underlying Agreement”).

 

In
consideration of the mutual promises below and the exchange of information
pursuant to this Agreement and in order to comply with all legal requirements
for the protection of this information, the parties therefore agree as follows:

 

Article I. Definitions of Terms

 

1.01         Business Associate shall have the meaning given to
such term in 45 C.F.R. §160.103.

 

1.02         C.F.R. shall mean the Code of Federal
Regulations.  All references to the
C.F.R. are to their then current version.

 

1.03         Designated Record Set shall have the meaning given to
such term in 45 C.F.R. §164.501.

 

1.04                           ePHI shall mean
electronically created, received, maintained or transmitted PHI.

 

1.05         HIPAA shall mean the Health Information Portability
and Accountability Act of 1996, as amended from time to time.

 

1.06         Privacy Laws shall mean HIPAA,
the HIPAA regulations and any other applicable state or federal laws or
regulations affecting or regulating the privacy and/or security of health
information (65 Fed. Reg. 82462-82829 (December 28, 2000 and as amended on
August 14, 2002 in 67 Fed Reg. 53,182-53273 (Part 160 and 164).)).

 

1.07         Protected Health Information (“PHI”) shall have the
meaning given to such term in 45 C.F.R. §164.501 and other applicable state
Privacy Laws.

 

1.08         “Required by Law” shall have the meaning given to
such phrase in 45 C.F.R. §164.501.

 

1.09         Security Rule shall have the meaning given such
term in 45 C.F.R. § 164.302-164.318.

 

BHL/diaDexus_070919

 

[***] 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

 

Article II.               Obligations
of Contractor

 

2.01         HIPAA Obligations.  Contractor acknowledges that federal
regulations relating to the confidentiality of PHI requires Covered Entities
and Business Associates to comply with HIPAA. 
HIPAA requires BHL to ensure that Business Associates who receive
confidential information in the course of providing services on behalf of BHL
comply with certain HIPAA obligations regarding the confidentiality of
PHI.  Accordingly, Contractor shall only
use and/or disclose PHI in a manner consistent with this Agreement, the
Underlying Agreement, the Privacy Rule, the Security Rule or as Required
by Law and only in connection with providing services hereunder.

 

2.02         Permitted Uses and Disclosures.  In connection with the services provided by
Contractor to BHL, Contractor may not use or disclose PHI received or created
pursuant to this Agreement as set forth in this Section 2.  Contractor shall maintain appropriate
safeguards to ensure that PHI is not used or disclosed other than as provided
by this Agreement or as required by Law.  Except
as may be limited by this Agreement, Contractor may use or disclose PHI it obtains or creates in its
capacity as Contractor for the proper management and administration of the
Contractor, to carry out Contractor’s legal responsibilities
under the Underlying Agreement
and this Agreement; provided that any
disclosures are Required by Law.
Contractor shall, if it makes a disclosure as permitted hereunder, (i) provide
training to members of Contractor’s workforce regarding the confidentiality
requirements in the Privacy Laws, the Security Rule and this Agreement;
and (ii) obtain reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only for the
purpose for which it was disclosed to such person and in accordance with the
Privacy Laws, and such person will notify Contractor of any instances of which it is aware
in which the confidentiality of such PHI has been breached.  Further, Contractor shall ensure that any use or disclosure of PHI are
subject to the principle of “minimum necessary use and disclosure,” i.e., only the PHI that is the
minimum necessary to accomplish the intended purpose of the use, disclosure, or
request may be disclosed.  Notwithstanding anything to the
contrary in this Agreement, Contractor may use PHI to report violations of law
to appropriate federal and state authorities, consistent with 45 C.F.R.
§164.502(j)(1), but only to the extent such reports are required by Law and
provided that (a) a copy of each such report is provided to BHL and (b) a
complete and accurate summary of any oral disclosure is provided to BHL.

 

Contractor shall require the
recipient of any PHI to agree to the same restrictions and conditions that
apply to Contractor under this Agreement as to the PHI, unless BHL agrees to
the contrary in writing with respect to a specific release of information.

 

2.03         Withdrawal of Authorization.  If the use or disclosure of PHI in this
Agreement is based upon an individual’s specific authorization for the use of
his or her PHI, and such individual revokes such authorization in writing, or
the effective date of such authorization has expired, or the authorization is
found to be defective in any manner that renders it invalid, BHL shall notify
Contractor of such revocation, expiration or defect in the authorization and
thereafter, Contractor shall cease the use and disclosure of any such
individual’s PHI except to the extent it has relied on such use or disclosure,
or where an exception under the Privacy Laws expressly applies.

 

2.04         ePHI
Security.  Contractor shall do all
the following:

(a)   Implement
administrative, physical and technical safeguards that reasonably and
appropriately protect the confidentiality, security, integrity and availability
of ePHI that Contractor creates,
receives, maintains or transmits on behalf of BHL, which in any event shall be
no less than the HIPAA-related implementation recommendations of the NIST/URAC/WEDI Health Care Security Workgroup (see www.wedi.org; keyword search “NIST” or “URAC”)
;

 

(b)   Ensure
that any agent, including a subcontractor, to whom Contractor provides ePHI agrees in writing to implement
reasonable and appropriate safeguards to protect ePHI; and

 

BHL/diaDexus_070919

 

[***] 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

 

(c)   Upon
request, make available to BHL Contractor’s documented information security
program, including the most recent ePHI risk analysis, policies, procedures,
security incidents and responses, and evidence of training.

 

2.05         Access to PHI by Individuals.  Contractor shall cooperate with BHL to
fulfill all requests by individuals for access to the individual’s PHI in a
Designated Record Set that are approved by BHL. 
Contractor shall cooperate with BHL in all respects necessary for BHL to
comply with applicable Privacy Laws. 
Because California law requires that copies of requested records be
forwarded to patients within fifteen (15) days of their request, Contractor
agrees to forward any copies requested by BHL for this purpose within 5
business days.  If Contractor receives a
request from an individual for access to PHI, Contractor promptly shall forward
such request to BHL and await BHL’s instructions with respect to denial or
approval of such request.  BHL shall be
solely responsible for determining the scope of PHI and Designated Record Set
with respect to each request by an individual for access to PHI.  Upon instruction from BHL, Contractor shall
deny such individual’s request or fulfill such individual’s request by
providing such individual’s PHI to such individual.  BHL shall reimburse Contractor a portion of
the fee charged by BHL to the individual that is proportional to the amount of
PHI produced by Contractor in relation to the amount of PHI produced by BHL,
less reasonable BHL administrative expenses.

 

2.06         Amendment of PHI. 
As directed and in accordance with the time frames reasonably specified
by BHL, Contractor shall incorporate all amendments or addenda to PHI received
from BHL, pursuant to 45 C.F.R. §164.526 and similar applicable Privacy
Laws.  Within ten (10) business days
following Contractor’s amendment of PHI as directed by BHL, Contractor shall
provide written notice to BHL confirming that Contractor has made the
amendments or addenda to PHI as directed by BHL and containing any other
information as may be necessary for BHL to provide adequate notice to the
individual in accordance with 45 C.F.R. §164.526 and similar applicable Privacy
Laws.

 

2.07.        Disclosure Accounting. In the event that Contractor
makes any disclosures of PHI that are subject to the accounting requirements of
45 C.F.R. §164.528, Contractor promptly shall report such disclosures to BHL.
The notice by Contractor to BHL of the disclosure shall include the name of the
individual, the recipient, and the reason for disclosure, and the date of the
disclosure.  Contractor shall maintain a
record of each such disclosure, including the date of the disclosure, the name
and, if available, the address of the recipient of the PHI, a brief description
of the PHI disclosed and a brief description of the purpose of the disclosure.  Contractor shall maintain this record for a
period of six (6) years and make available to BHL upon request in an
electronic format so that BHL may meet its disclosure accounting obligations
under 45 C.F.R. §164.528.

 

2.08         Reporting and Mitigating Unauthorized Uses and Disclosures
of PHI.  Promptly following its
notice of the same, Contractor shall report to BHL any uses, disclosures or
risks of disclosure of PHI not authorized by this Agreement of which it becomes
aware and, with respect to ePHI, any
security incident, including any attempted or successful unauthorized access,
use, disclosure, modification, or destruction of ePHI or interference with information system operations all
as required by applicable Privacy Laws and applicable state identity theft laws
(e.g., Cal. Civ. Code §1798.82). 
Contractor agrees to mitigate, to the extent practicable, the
deleterious effects of any use or disclosure of PHI not authorized by this
Agreement.

 

2.09         Ownership of Information.  As between Contractor and BHL, all PHI and ePHI shall be deemed owned by BHL unless otherwise agreed in
writing by BHL.  During the term of this
Agreement, Contractor and any authorized subcontractors shall have the right to
use the PHI and ePHI solely for the purposes of
this Agreement.  Contractor and its
agents shall not have the right to de-identify the PHI and/or ePHI unless agreed in writing by BHL.

 

2.10         Internal Practices, Books, and Records.  Contractor shall make available its internal
practices, books, and records relating to the use and disclosure of PHI
received from, created, or received by Contractor on behalf of BHL to the U.S.
Department of Heath and Human Services or his designee for the purpose of
determining BHL’s compliance with 45 C.F.R. pt. 160 and 164, subparts A and E
and amendments thereto.

 

BHL/diaDexus_070919

 

[***] 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

 

2.11         BHL’s Obligations.

 

(a)   BHL shall notify Contractor of any limitation(s) in
its notice of privacy practices of BHL in accordance with 45 C.F.R. § 164.520,
to the extent that such limitation may affect Contractor’s use or disclosure of
PHI.

 

(b) 
BHL shall notify Contractor of any changes in, or revocation of, permission by
individual to use or disclose PHI, to the extent that such changes may affect
Contractor’s use or disclosure of PHI.

 

(c) 
BHL shall notify Contractor of any restriction to the use or disclosure of PHI
that BHL has agreed to in accordance with 45 C.F.R. § 164.522, to the extent
that such restriction may affect Contractor’s use or disclosure of such PHI.

 

2.12         Permitted Requests from BHL.  BHL shall not request Contractor to use or
disclose PHI in any manner that would not be permissible under the Privacy Rule if
done by BHL.

 

Article III.              Term
and Termination

 

3.01         Term.  This Agreement shall commence the Effective
Date and end when one party notifies the other party of its intent to terminate
pursuant to Section 3.02.

 

3.02         Termination. 
Either party to this Agreement may terminate the Agreement upon
provision of thirty (30) days’ prior written notice.

 

3.03         Effects of Termination; Disposal of PHI and/or ePHI. Upon termination of this Agreement, Contractor
shall return to BHL or destroy all PHI and/or ePHI
that Contractor obtained or maintained pursuant to this Agreement on behalf of
BHL, including the PHI and/or ePHI in the
possession of any of Contractor’s agents or affiliates.  If the parties determine that returning or
destroying the PHI is infeasible, Contractor shall provide to BHL notification
of the specific conditions that make return or destruction infeasible.  Contractor shall extend the protections
provided under this Agreement to such PHI and/or ePHI,
and limit further use or disclosure of such PHI and/or ePHI
to those purposes that make the return or destruction of the PHI and/or ePHI infeasible. 
Contractor shall require that its agents, affiliates, subsidiaries and
subcontractors agree to the extension of all protections, limitations and
restrictions required of Contractor hereunder to the extent such agents,
affiliates, subsidiaries or subcontractors are in possession of such PHI and/or
ePHI.  This Section 3.03 shall
survive the termination of this Agreement.

 

Article IV.              Miscellaneous

 

4.01         Notices.  Any
notice required to be given pursuant to the terms and provisions of this
Agreement shall be in writing and may be either personally delivered, sent by commercial;
overnight delivery service or sent by registered or certified mail in the
United States Postal Service, Return Receipt Requested, postage prepaid,
addressed to each party at the addresses which follow or to such other
addresses as the parties may hereinafter designate in writing:

 

	
   

  	
  BHL:

  	
  839 Mitten Road

  	
   

  	
   

  
	
   

  	
   

  	
  Burlingame,
  CA 94010

  	
   

  	
   

  
	
   

  	
   

  	
  Attn:

  	
  General
  Counsel

  	
   

  
						

 

BHL/diaDexus_070919

 

[***] 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

 

 

	
  Contractor:

  	
   

  	
  diaDexus, Inc.

  	
   

  	
   

  
	
   

  	
   

  	
  343 Oyster Point Boulevard

  	
   

  	
   

  
	
   

  	
   

  	
  South San Francisco, CA
  94080-1913

  	
   

  	
   

  
	
   

  	
   

  	
  Attn:

  	
  Patrick Plewman

  	
   

  
	
   

  	
   

  	
   

  	
  Chief Executive Officer

  	
   

  
						

 

Any such notice shall be
deemed to have been given, if mailed as provided herein, as of the date
received.

 

4.02         Amendments. 
This Agreement may, from time to time, be modified or amended in writing
and such written modifications are signed by both parties to this Agreement.

 

4.03         Counterparts. 
This Agreement may be executed in counterparts, any of which is
considered to be an original agreement.

 

4.04         Assignment/Subcontracting.  This Agreement shall inure to the benefit of
and be binding upon the parties hereto and their respective legal
representatives, successors and assigns. 
Neither party may assign the rights or obligations under this Agreement
without the express written consent of the other party; provided, however, that
either party may assign this Agreement without such consent to any permitted
assignee of such party’s rights and obligations under the Underlying Agreement.

 

4.05         Construction. 
This Agreement shall be construed as broadly as necessary to implement
and comply with the HIPAA regulations. 
The parties agree that any ambiguity in this Agreement shall be resolved
in favor of a meaning that complies and is consistent with the HIPAA
regulations.

 

IN
WITNESS WHEREOF, the parties hereto have duly executed this agreement to be
effective as of the date of the Underlying Agreement.

 

	
  BHL

  	
   

  	
  CONTRACTOR

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Frank
  Ruderman

  	
   

  	
  Patrick
  Plewman

  
	
   

  	
   

  	
   

  
	
  Title:
  President

  	
   

  	
  Title:
  Chief Executive Officer

  
	
   

  	
   

  	
   

  
	
  Date:
  November 9, 2007

  	
   

  	
  Date:

  	
  11/16/07

  

 

BHL/diaDexus_070919

 

[***] 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.

 

15Exhibit 10.27

 

 

Facility
Participation Agreement

 

This Agreement is entered
into by and between United HealthCare Insurance Company, contracting on behalf
of itself, and the other entities that are United’s Affiliates (collectively
referred to as “United”) and Berkeley Heart Laboratory (“Facility”).

 

This Agreement is effective
on the later of the following dates (the “Effective Date”):

 

i)              December 1,
2007 or

 

ii)             the first day
of the first calendar month that begins at least 30 days after the date when this
Agreement has been executed by all parties.

 

Through contracts with
physicians and other providers of health care services, United maintains one or
more networks of providers that are available to Customers.  Facility is a provider of health care services.

 

United wishes to arrange to
make Facility’s services available to Customers.  Facility wishes to provide such services,
under the terms and conditions set forth in this Agreement.

 

The parties therefore enter
into this Agreement.

 

Article I.

Definitions

 

The following terms when
used in this Agreement have the meanings set forth below:

 

1.1          “Benefit
Plan” means a certificate of coverage, summary plan description, or
other document or agreement, whether delivered in paper, electronic, or other
format, under which a Payer is obligated to provide coverage of Covered
Services for a Customer.

 

1.2          “Covered
Service” is a health care service or product for which a Customer is
entitled to receive coverage from a Payer, pursuant to the terms of the
Customer’s Benefit Plan with that Payer.

 

1.3          “Customary
Charge” is the fee for health care services charged by Facility that
does not exceed the fee Facility would ordinarily charge another person
regardless of whether the person is a Customer.

 

1.4          “Customer”
is a person eligible and enrolled to receive coverage from a Payer for Covered
Services.

 

1.5          “Payment
Policies” are the guidelines adopted by United outside of this
Agreement for calculating payment of claims to facilities (including claims of
Facility under this Agreement).  The
Payment Policies may change from time to time as discussed in section 5.1 of
this Agreement.

 

	
  UnitedHealthcare
  Facility Agreement

  	
   

  	
  Confidential and
  Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
   

  	
  0507

  

 

[***] 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.

 

1

 

 

1.6          “Payer”
is an entity obligated to a Customer to provide reimbursement for Covered
Services under the Customer’s Benefit Plan, and authorized by United to access
Facility’s services under this Agreement.

 

1.7          “Protocols”
are the programs, protocols and administrative procedures adopted by United or
a Payer to be followed by Facility in providing services and doing business
with United and Payers under this Agreement. 
These Protocols may include, among other things, credentialing and
recredentialing processes, utilization management and care management
processes, quality improvement, peer review, Customer grievance, concurrent
review, or other similar United or Payer programs.  The Protocols may change from time to time as
discussed in section 4.4 of this Agreement.

 

1.8          “United’s
Affiliates” are those entities controlling, controlled by, or under
common control with, United HealthCare Insurance Company.

 

Article II.

Representations and
Warranties

 

2.1          Representations and Warranties of Facility.  Facility, by virtue
of its execution and delivery of this Agreement, represents and warrants as
follows:

 

a)             Facility
is a duly organized and validly existing legal entity in good standing under
the laws of its jurisdiction of organization.

 

b)            Facility
has all requisite corporate power and authority to conduct its business as
presently conducted, and to execute, deliver and perform its obligations under
this Agreement.  The execution, delivery
and performance of this Agreement by Facility have been duly and validly
authorized by all action necessary under its organizational documents and
applicable corporate law.  This Agreement
has been duly and validly executed and delivered by Facility and (assuming the
due authorization, execution and delivery of this Agreement by United)
constitutes a valid and binding obligation of Facility, enforceable against
Facility in accordance with its terms, except as such enforceability may be
limited by the availability of equitable remedies or defenses and by applicable
bankruptcy, insolvency, reorganization, moratorium or similar laws affecting
the enforcement of creditors’ rights generally.

 

c)             The
execution, delivery and performance of this Agreement by Facility do not and
will not violate or conflict with (i) the organizational documents of
Facility, (ii) any material agreement or instrument to which Facility is a
party or by which Facility or any material part of its property is bound, or (iii) applicable
law.

 

d)            Facility
has obtained and holds all registrations, permits, licenses, and other
approvals and consents, and has made all filings, that it is required to obtain
from or make with all governmental entities under applicable law in order to
conduct its business as presently conducted and to enter into and perform its
obligations under this Agreement.

 

e)             Facility
has been given an opportunity to review the Protocols and Payment Policies and
acknowledges that it is bound by the Protocols and that claims under this
Agreement will be paid in accordance with the Payment Policies.

 

f)             Each
submission of a claim by Facility pursuant to this Agreement shall be deemed to
constitute the representation and warranty by it to United that (i) the
representations and

 

	
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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.

 

2

 

warranties of it set forth in this section 2.1 and elsewhere
in this Agreement are true and correct as of the date the claim is submitted, (ii) it
has complied with the requirements of this Agreement with respect to the
Covered Services involved and the submission of such claim, (iii) the
charge amount set forth on the claim is the Customary Charge and (iv) the
claim is a valid claim.

 

2.2          Representations and Warranties of United.  United, by virtue of
its execution and delivery of this Agreement, represents and warrants as
follows:

 

a)             United
is a duly organized and validly existing legal entity in good standing under
the laws of its jurisdiction of organization.

 

b)            United
has all requisite corporate power and authority to conduct its business as
presently conducted, and to execute, deliver and perform its obligations under
this Agreement.  The execution, delivery
and performance of this Agreement by United have been duly and validly
authorized by all action necessary under its organizational documents and
applicable corporate law.  This Agreement
has been duly and validly executed and delivered by United and (assuming the
due authorization, execution and delivery of this Agreement by Facility)
constitutes a valid and binding obligation of United, enforceable against
United in accordance with its terms, except as such enforceability may be
limited by the availability of equitable remedies or defenses and by applicable
bankruptcy, insolvency, reorganization, moratorium or similar laws affecting
the enforcement of creditors’ rights generally.

 

c)             The
execution, delivery and performance of this Agreement by United do not and will
not violate or conflict with (i) the organizational documents of United, (ii) any
material agreement or instrument to which United is a party or by which United
or any material part of its property is bound, or (iii) applicable law.

 

d)            United
has obtained and holds all registrations, permits, licenses, and other
approvals and consents, and has made all filings, that it is required to obtain
from or make with all governmental entities under applicable law in order to
conduct its business as presently conducted and to enter into and perform its
obligations under this Agreement.

 

Article III.

Applicability of this
Agreement

 

3.1          Facility’s Services.  This Agreement applies
to Covered Services provided at Facility’s service locations set forth in
Appendix 1.  In the event Facility begins
providing new service types, or services at other locations or under other tax
identification number(s), (either by operating such locations itself, or by
acquiring, merging or affiliating with an existing provider that was not
already under contract with United or one of United’s Affiliates to participate
in a network of health care providers), such additional tax identification
numbers, service types, or locations will become subject to this Agreement only
upon the written agreement of the parties.

 

In
the event Facility acquires or is acquired by, merges with, or otherwise
becomes affiliated with another provider of health care services that is
already under contract with United or one of United’s Affiliates to participate
in a network of health care providers, the non-payment terms of this Agreement
will remain in effect and supersede the terms and conditions of the other
agreement.  In the case of such
affiliation, the payment rates for Covered Services set forth in the continuing
Agreement will be the lesser of (1) the rates set forth in the other

 

	
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3

 

 

agreement between another
provider of health care services and United, or (2) the rates set forth in
the applicable Payment Appendix to this Agreement.

 

Facility will not transfer
all or some of its assets to any other entity during the term of this Agreement,
with the result that all or some of the Covered Services subject to this
Agreement will be rendered by the other entity rather than by Facility, without
the express written agreement of United.

 

3.2          Payers and Benefit
Plan types.  United may allow Payers to access Facility’s
services under this Agreement for the Benefit Plan types described in Appendix
2.  Appendix 2 may be modified by United
upon 30 days written or electronic notice.

 

3.3          Services not covered
under a Benefit Plan.  This Agreement does not apply to services not
covered under the applicable Benefit Plan. 
Facility may seek and collect payment from a Customer for such services,
provided that the Facility first obtain the Customer’s written consent.

 

This section does not
authorize Facility to bill or collect from Customers for Covered Services for
which claims are denied or otherwise not paid. 
That issue is addressed in sections 6.5 and 6.8 of this Agreement.

 

3.4          Patients who are not
Customers.  This Agreement does not apply to services
rendered to patients who are not Customers at the time the services were
rendered.  Section 6.6 of this
Agreement addresses circumstances in which claims for services rendered to such
persons are inadvertently paid.

 

3.5          Health Care.  Facility acknowledges
that this Agreement and Customer Benefit Plans do not dictate the health care
provided by Facility, or govern a physician’s or hospital’s determination of
what care to provide its patients, even if those patients are Customers.  The decision regarding what care is to be
provided remains with Customers and their physicians, and not with United or
any Payer.

 

3.6          Communication with
Customers.  Nothing in this Agreement is intended to
limit Facility’s right or ability to communicate fully with a Customer and the
Customer’s physician regarding the Customer’s health condition and treatment
options.  Facility is free to discuss all
treatment options without regard to whether or not a given option is a Covered
Service.  Facility is free to discuss
with a Customer any financial incentives Facility may have under this Agreement,
including describing at a general level the payment methodologies contained in
this Agreement.

 

Article IV.

Duties of Facility

 

4.1          Provide Covered Services.  Facility will provide
Covered Services to Customers.  Facility
must be in compliance with section 2.1(d) of this Agreement and
credentialed by United or its delegate prior to furnishing any Covered Services
to Customers under this Agreement.

 

4.2          Nondiscrimination.  Facility will not
discriminate against any patient, with regard to quality of service or
accessibility of services, on the basis that the patient is a Customer.

 

4.3          Accessibility.  Facility will be open 24 hours a day, seven
days a week.

 

	
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omitted material has been filed separately with the Securities and Exchange
Commission.

 

4

 

4.4          Cooperation with Protocols.  Facility will
cooperate with and be bound by United’s and Payers’ Protocols.  The Protocols include but are not limited to
all of the following:

 

1)             Facility will use reasonable commercial efforts to direct
Customers only to other providers that participate in United’s network, except
as permitted under the Customer’s Benefit Plan or otherwise authorized by
United or Payer.

 

2)             Facility will make its best efforts to assure that all
Facility-based physician groups participate in United’s network as long as this
Agreement is in effect.

 

In the event that a
Facility-based physician group is not a participating provider with United,
Facility’s Chief Financial Officer or equivalent senior level officer (“Facility
Representative”) will assist United in its efforts to negotiate an agreement
with such group.  Upon request by United,
Facility Representative will:

 

a)             meet with
Facility-based physician group to encourage participation.  Facility Representative shall provide United
with meeting minutes of any such meeting within 15 days.  Meeting minutes will include a summary of the
key discussion points and an outline of any actionable resolution options
deemed by Facility Representative.

 

b)            write
letter(s) to Facility-based physician group encouraging the group to
negotiate in good faith with United.  The
letter will also outline any contractual requirements in the agreement between
Facility and Facility-based physician group that requires Facility-based
physician group to (1) negotiate in good faith with third party payers, (2) participate
in third party payer networks, and (3) other provisions related to
Facility-based physician group’s participation with third party payers.

 

c)             invoke
any applicable penalties or other contractual terms in its agreement with
Facility-based physician group related to its non-participating status with a
third party payer.

 

d)            allow
independent legal counsel (mutually agreeable to all relevant parties) to
review Facility/Facility-based physician agreement to ensure Facility is fully
invoking all the relevant terms and conditions of such agreement to require or
promote Facility-based physician group’s participation status with United.

 

United warrants that it will
negotiate with Facility-based physician groups in good faith.  Facility acknowledges that United will have
no responsibility for the credentialing of any employed or sub-contracted
Facility-based provider.

 

3)             Facility will provide notification for certain Covered
Services, accept and return telephone calls from United staff, and respond to
United requests for clinical information, as required by United or Payer as
described in the Protocols.

 

The Protocols will be made
available to Facility online or upon request. 
Some or all Protocols also may be disseminated in the form of an
administrative manual or guide or in other communications.

 

United
may change the Protocols from time to time. 
United will use reasonable commercial efforts to inform Facility at
least 30 days in advance of any material changes to the Protocols.  United may implement changes in the Protocols
without Facility’s consent if such change is applicable to all or substantially
all of the facilities in United’s network located in the same state

 

	
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omitted material has been filed separately with the Securities and Exchange
Commission.

 

5

 

as Facility.  Otherwise, changes to the Protocols proposed
by United to be applicable to Facility are subject to the terms of section 9.2
of this Agreement applicable to amendments.

 

4.5          Employees and subcontractors.  Facility will assure
that its employees, affiliates and any individuals or entities subcontracted by
Facility to render services in connection with this Agreement adhere to the requirements
of this Agreement.  The use of employees,
affiliates or subcontractors to render services in connection with this
Agreement will not limit Facility’s obligations and accountability under this
Agreement with regard to such services. 
Facility affiliates are those entities that control, are controlled by
or are under common control with Facility.

 

4.6          Licensure.  Facility will maintain, without material
restriction, such licensure, registration, and permits as are necessary to
enable Facility to lawfully perform this Agreement.

 

4.7          Liability Insurance.  Facility shall
procure and maintain liability insurance. 
Except to the extent coverage is a state mandated placement, Facility’s
coverage must be placed with responsible, financially sound insurance carriers
authorized or approved to write coverage in the state in which the Covered
Services are provided.  Facility’s
liability insurance shall be, at a minimum, of the types and in the amounts set
forth below.  Facility’s medical
malpractice insurance shall be either occurrence or claims made with an
extended period reporting option.  Prior
to the Effective Date of this Agreement and within 10 days of each policy
renewal thereafter, Facility shall submit to United in writing evidence of
insurance coverage.

 

	
  TYPE OF INSURANCE

  	
   

  	
  MINIMUM LIMITS

  
	
   

  	
   

  	
   

  
	
  Medical malpractice and/or professional liability insurance

  	
   

  	
  Five Million Dollars ($5,000,000.00) per occurrence and aggregate

  
	
   

  	
   

  	
   

  
	
  Commercial general and/or umbrella liability insurance

  	
   

  	
  Five Million Dollars ($5,000,000.00) per occurrence and aggregate

  

 

In lieu of purchasing the
insurance coverage required in this section, Facility may, with the prior
written approval of United, self-insure its medical malpractice and/or
professional liability, as well as its commercial general liability.  Facility shall maintain a separate reserve
for its self-insurance.  Prior to the
Effective Date, Facility shall provide a statement, verified by an independent
auditor or actuary, that its reserve funding levels and process of funding
appears adequate to meet the requirements of this section and fairly represents
the financial condition of the fund. 
Facility will provide a similar statement during the term of this
Agreement upon United’s request, which will be made no more frequently than
annually.  Facility will assure that its
self-insurance fund will comply with applicable laws and regulations.

 

4.8          Notice.  Facility will give
notice to United within 10 days after any event that causes Facility to be out
of compliance with section 4.6 or 4.7 of this Agreement, or of any change in
Facility’s name, ownership, control, or Taxpayer Identification Number.  In addition, Facility will give written
notice to United 45 days prior to the effective date of changes in existing
remit address(es) and other demographic information.

 

	
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6

 

4.9          This section intentionally left blank.

 

4.10        Maintenance of and
Access to Records.  Facility will maintain adequate medical,
financial and administrative records related to Covered Services rendered by
Facility under this Agreement, including claims records, for at least 6 years
following the end of the calendar year during which the Covered Services are
provided, unless a longer retention period is required by applicable law.

 

Facility will provide access
to these records as follows:

 

i) to United or its
designees, in connection with United’s utilization management/Care
CoordinationsSM, quality
assurance and improvement and for claims payment and other administrative
obligations, including reviewing Facility’s compliance with the terms and
provisions of this Agreement and appropriate billing practice.  Facility will provide access during ordinary
business hours within fourteen days after a request is made, except in cases of
a United audit involving a fraud investigation or the health and safety of a
Customer (in which case, access shall be given within 48 hours after the
request) or of an expedited Customer appeal or grievance (in which case, access
will be given so as to enable United to reasonably meet the timelines for
determining the appeal or grievance); and

 

ii) to agencies of the
government, in accordance with applicable law, to the extent such access is
necessary to comply with regulatory requirements applicable to Facility,
United, or Payers.

 

Facility will cooperate with
United on a timely basis in connection with any such audit including, among
other things, in the scheduling of and participation in an audit exit interview
within 30 days of United’s request.

 

If such information and
records are requested by United, Facility shall provide copies of such records
free of charge.

 

4.11        Access to Data.  Facility represents
that in conducting its operations, it collects and reviews certain quality data
relating to care rendered by Facility that is reported in a manner which has
been validated by a third party as having a clear, evidence-based link to
quality or safety (e.g., AHRQ standards) or which has been created by employer
coalitions as proxies for quality (e.g., Leapfrog standards).

 

United recognizes that
Facility has the sole discretion to select the metrics which it will track from
time to time and that Facility’s primary goal in so tracking is to advance the
quality of patient care.  If the
information that a facility chooses to report on is available in the public
domain in a format that includes all data elements required by
UnitedHealthcare, UnitedHealthcare will obtain quality information directly
from the source to whom the facility reported. 
If the facility does not report metrics in the public domain, on a
quarterly basis, Facility will share these metrics with United as tracked
against a database of all discharged, commercial patients (including patients
who are not United customers).  United
may publish this data to entities to which United renders services or seeks to
render services, and to Customers.

 

4.12        Compliance with law.  Facility will comply
with applicable regulatory requirements, including but not limited to those
relating to confidentiality of Customer medical information.

 

4.13        Electronic connectivity.  When made available by United, Facility will
communicate with United electronically. 
Facility will use www.unitedhealthcareonline.com to check eligibility

 

	
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omitted material has been filed separately with the Securities and Exchange
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status, claims status, and submit requests for claims
adjustment for products supported by UnitedHealthcare Online® or other online
resources as supported for additional products. 
Facility agrees to use www.unitedhealthcareonline.com for additional
functionalities (for instance, notification of admission) after United informs
Facility that such functionalities have become available for the applicable
Customer.

 

4.14        Implementation of
Patient Safety Programs.  Facility will implement quality programs
rcconunended by nationally recognized independent third parties on a reasonably
prompt basis.

 

4.15        Performance Standards
and Guarantees.  Facility hereby accepts and agrees to the
performance standards and guarantees set forth in the Performance Standards and
Guarantees Appendix attached to this Agreement, including the payment which
shall be at risk should Facility’s performance fall below the indicated
targets.

 

Article V.

Duties of United and
Pavers

 

5.1          Payment of Claims.  As described in
further detail in Article VI of this Agreement, Payers will pay Facility
for rendering Covered Services to Customers. 
United will make its Payment Policies available to Facility online or
upon request.  United may change its
Payment Policies from time to time.

 

5.2          Liability Insurance.  United will procure
and maintain professional and general liability insurance and other insurance,
as United reasonably determines may be necessary, to protect United and
United’s employees against claims, liabilities, damages or judgments that arise
out of services provided by United or United’s employees under this Agreement.

 

5.3          Licensure.  United will maintain,
without material restriction, such licensure, registration, and permits as are
necessary to enable United to lawfully perform this Agreement.

 

5.4          Notice.  United will give
written notice to Facility within 10 days after any event that causes United to
be out of compliance with section 5.2 or 5.3 of this Agreement, or of any
change in United’s name, ownership, control, or Taxpayer Identification
Number.  This section does not apply to
changes of ownership or control that result in United being owned or controlled
by an entity with which it was already affiliated prior to the change.

 

5.5          Compliance with law.  United will comply
with applicable regulatory requirements, including but not limited to those
relating to confidentiality of Cu9stomer medical information and those relating
to prompt payment of claims, to the extent those requirements are applicable.

 

5.6          Electronic
connectivity.  United will communicate with Facility
electronically by providing eligibility status, claims status, and accepting
requests for claim adjustments, for those products supported by
www.unitedhealthcareonline.com. United will communicate enhancements in
www.unitedhealthcareonline.com functionality as they become available, as
described in Section 4.13, and will make information available as to which
products are supported by www.unitedhealthcareonline.com.

 

5.7          Employees and
subcontractors.  United will assure that its employees,
affiliates and any individuals or entities subcontracted by United to render
services in connection with this Agreement adhere to the requirements of this
Agreement.  The use of employees,
affiliates or

 

	
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8

 

subcontractors to render services in connection with this
Agreement will not limit United’s obligations and accountability under this
Agreement with regard to such services.

 

Article VI.

Submission,
Processing. and Payment of Claims

 

6.1          Form and content
of claims.  Facility must submit claims for Covered
Services in a manner and format prescribed by United, as further described in
the Protocols.  Unless otherwise directed
by United, Facility shall submit claims using current CMS 1500 or UB92 forms
for paper claims and HIPAA standard professional or institutional claim formats
for electronic claims, as applicable, with applicable coding including, but not
limited to, ICD-9-CM, CPT, Revenue and HCPCS coding.

 

6.2          Electronic filing of claims.  Within six months
after the Effective Date of this Agreement, Facility will use electronic submission
for all of its claims under this Agreement that United is able to accept
electronically.

 

6.3          Time to file claims.  All information
necessary to process a claim must be received by United no more than 90 days
from the date Covered Services are rendered. 
In the event United requests additional information in order to process
the claim, Facility will provide such additional information within 90 days of
United’s request.  If Payer is not the
primary payer, and Facility is pursuing payment from the primary payer, the 90
day filing limit will begin on the date Facility receives the claim response
from the primary payer.

 

6.4          Payment of claims.  Payer will pay claims
for Covered Services as further described in the applicable Payment Appendix to
this Agreement and in accordance with Payment Policies.

 

Claims for Covered Services
subject to coordination of benefits will be paid in accordance with the
Customer’s Benefit Plan and applicable state and federal law.

 

The obligation for payment
under this Agreement is solely that of Payer, and not that of United unless
United is the Payer.

 

6.5          Denial of Claims for Not Following Protocols
or Not Filing Timely.  Payment may be denied in whole or in part if
Facility does not comply with a Protocol or does not file a timely claim under
section 6.3 of this Agreement.

 

In the event that payment of
a claim is denied for lack of notification or for untimely filing, the denial
will be reversed if Facility appeals within 12 months after the date of denial
and can show all of the following:

 

	
  i)

  	
   

  	
  that, at the time the Protocols
  required notification or at the time the claim was due, Facility did not know
  and was unable to reasonably determine that the patient was a Customer,

  
	
  ii)

  	
   

  	
  that Facility took reasonable
  steps to learn that the patient was a Customer, and

  
	
  iii)

  	
   

  	
  that Facility promptly provided
  notification, or filed the claim, after learning that the patient was a
  Customer.

  

 

6.6          Retroactive correction of information
regarding whether patient is a Customer.  Prior to rendering services, Facility shall
ask the patient to present his or her Customer identification card.

 

	
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In addition, Facility may contact United to obtain the most
current information on the patient as a Customer.

 

However, Facility
acknowledges that such information provided by United is subject to change
retroactively, under the following circumstances, (1) if United has not
yet received information that an individual is no longer a Customer; (2) if
the individual’s Benefit Plan is terminated retroactively for any reason
including, but not limited to, non-payment of premium; (3) as a result of
the Customer’s final decision regarding continuation of coverage pursuant to
state and federal laws; or (4) if eligibility information United receives
is later proven to be false.

 

If Facility provides health
care services to an individual, and it is determined that the individual was
not a Customer at the time the health care services were provided, those
services shall not be eligible for payment under this Agreement and any claims
payments made with regard to such services may be recovered as overpayments
under the process described in section 6.10 of this Agreement.  Facility may then directly bill the
individual, or other responsible party, for such services.

 

6.7          Payment under this Agreement is payment in
full. 
Payment as provided under section 6.4, together with any co-payment,
deductible or coinsurance for which the Customer is responsible under the
Benefit Plan, is payment in full for a Covered Service.  Facility will not seek to recover, and will
not accept, any payment from Customer, United, Payer or anyone acting in their
behalf, in excess of payment in full as provided in this section 6.7,
regardless of whether such amount is less than Facility’s billed charge or
Customary Charge.

 

6.8          Customer “Hold Harmless.”  Facility will not
bill or collect payment from the Customer, or seek to impose a lien, for the
difference between the amount paid under this Agreement and Facility’s billed
charge or Customary Charge, or for any amounts denied or not paid under this
Agreement due to:

 

	
  i)

  	
   

  	
  Facility’s failure to comply with
  the Protocols,

  
	
  ii)

  	
   

  	
  Facility’s failure to file a
  timely claim,

  
	
  iii)

  	
   

  	
  Payer’s Payment Policies,

  
	
  iv)

  	
   

  	
  inaccurate or incorrect claim
  processing,

  
	
  v)

  	
   

  	
  insolvency or other failure by
  Payer to maintain its obligation to fund claims payments, if Payer is United,
  or is an entity required by applicable law to assure that its Customers not
  be billed in such circumstances.

  

 

This obligation to refrain
from billing Customers applies even in those cases in which Facility believes
that United or Payer has made an incorrect determination.  In such cases, Facility may pursue remedies
under this Agreement against United or Payer, as applicable, but must still
hold the Customer harmless.

 

In the event of a default by
a Payer other than those Payers covered by subsection v) of this Section 6.8,
Facility may seek payment directly from the Payer or from Customers covered by
that Payer.  However, Facility may do so
only if it first inquires in writing to United as to whether the Payer has
defaulted and, in the event that United confirms that Payer has defaulted
(which confirmation will not be unreasonably withheld), Facility then gives
United 15 days prior written notice of Facility’s intent to seek payment from
Payer or Customers.  For purposes of this
paragraph, a default is a systematic failure by a Payer to fund claims payments
related to Customers covered through that Payer; a default does not occur in
the case of a dispute as to whether certain claims should be paid or the
amounts that should be paid for certain claims.

 

	
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This section
6.8 and section 6.7 will survive the termination of this Agreement, with regard
to Covered Services rendered prior to when the termination takes effect.

 

6.9          Consequences
for failure to adhere to Customer protection requirements. 
If Facility collects payment from, brings a collection action against,
or asserts a lien against a Customer for Covered Services rendered (other than
for the applicable co-payment, deductible or coinsurance), contrary to section
6.7 or 6.8 of this Agreement, Facility shall be in breach of this
Agreement.  This section 6.9 will apply
regardless of whether Customer or anyone purporting to act on Customer’s behalf
has executed a waiver or other document of any kind purporting to allow
Facility to collect such payment from Customer.

 

In the event
of such a breach, Payer may deduct, from any amounts otherwise due Facility,
the amount wrongfully collected from Customers, and may also deduct an amount
equal to any costs or expenses incurred by the Customer, United or Payer in
defending the Customer from such action and otherwise enforcing sections 6.7
through 6.9 of this Agreement.  Any
amounts deducted by Payer in accordance with this provision shall be used to
reimburse the Customer and to satisfy any costs incurred.  The remedy contained in this paragraph does
not preclude United from invoking any other remedy for breach that may be
available under this Agreement.

 

6.10        Correction
of overpayments or underpayments of claims. 
In the event that either Party believes that a claim has not been paid
correctly, or that funds were paid beyond or outside of what is provided for
under this Agreement, either party may seek correction of the payment, except
that Facility may not seek correction of a payment more than 12 months after it
was made.

 

Facility will
repay overpayments within 30 days of notice of the overpayment.  Facility will promptly report any credit
balance that it maintains with regard to any claim overpayment under this
Agreement, and will return such overpayment to United within 30 days after
posting it as a credit balance.

 

Facility
agrees that recovery of overpayments may be accomplished by offsets against
future payments.

 

Article VII.

Dispute
Resolution

 

The parties
will work together in good faith to resolve any and all disputes between them
(hereinafter referred to as “Disputes”) including but not limited to all
questions of arbitrability, the existence, validity, scope or termination of
the Agreement or any term thereof.

 

If the parties
are unable to resolve any such Dispute within 60 days following the date one
party sent written notice of the Dispute to the other party, and if either
party wishes to pursue the Dispute, it shall thereafter be submitted to binding
arbitration before a panel of three arbitrators in accordance with the
Commercial Dispute Procedures of the American Arbitration Association, as they
may be amended from time to time (see http://www.adr.org).  Unless otherwise agreed to in writing by the
parties, the party wishing to pursue the Dispute must initiate the arbitration within
one year after the date on which notice of the Dispute was given or shall be
deemed to have waived its right to pursue the dispute in any forum.

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***] 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

 

Any
arbitration proceeding under this Agreement shall be conducted in San Francisco
County, CA.  The arbitrator(s) may
construe or interpret but shall not vary or ignore the terms of this Agreement
and shall be bound by controlling law.  The arbitrator(s) shall have no authority
to award punitive, exemplary, indirect or special damages, except in connection
with a statutory claim that explicitly provides for such relief.

 

The parties
expressly intend that any dispute relating to the business relationship between
them be resolved on an individual basis so that no other dispute with any third
party(ies) may be consolidated or joined with the dispute.  The parties agree that any arbitration ruling
by an arbitrator allowing class action arbitration or requiring consolidated
arbitration involving any third party(ies) would be contrary to their intent
and would require immediate judicial review of such ruling.

 

If the Dispute
pertains to a matter which is generally administered by certain United procedures,
such as a credentialing or quality improvement plan, the policies and
procedures set forth in that plan must be fully exhausted by Facility before
Facility may invoke any right to arbitration under this Article VII.

 

The decision
of the arbitrator(s) on the points in dispute will be binding, and
judgment on the award may be entered in any court having jurisdiction
thereof.  The parties acknowledge that
because this Agreement affects interstate commerce the Federal Arbitration Act
applies.

 

In the event
that any portion of this Article or any part of this Agreement is deemed
to be unlawful, invalid or unenforceable, such unlawfulness, invalidity or
unenforceability shall not serve to invalidate any other part of this Article or
Agreement.  In the event any court
determines that this arbitration procedure is not binding or otherwise allows
litigation involving a Dispute to proceed, the parties hereby waive any and all
right to trial by jury in, or with respect to, such litigation.  Such litigation would instead proceed with
the judge as the finder of fact.

 

In the event a
party wishes to terminate this Agreement based on an assertion of uncured
material breach, and the other party disputes whether grounds for such a
termination exist, the matter will be resolved through arbitration under this Article VII.  While such arbitration remains pending, the
termination for breach will not take effect.

 

This Article VII
governs any dispute between the parties arising before or after execution of
this Agreement, and shall survive any termination of this Agreement.

 

Article VIII.

Term and
Termination

 

8.1          Term. 
This Agreement shall take effect on the Effective Date.  This Agreement shall have an initial term of five
year and renew automatically for renewal terms of one year, until terminated
pursuant to Section 8.2.

 

8.2          Termination. 
This Agreement may be terminated under any of the following
circumstances:

 

	
  i)

  	
   

  	
  by mutual written
  agreement of the parties;

  
	
  ii)

  	
   

  	
  by either party,
  upon at least 180 days prior written notice, effective at the end of year
  three, the end of year four, the end of the initial term, or effective at the
  end of any renewal term;

  

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***]
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

 

	
  iii)

  	
   

  	
  by either party
  upon 60 days written notice in the event of a material breach of this
  Agreement by the other party, except that such a termination will not take
  effect if the breach is cured within 60 days after notice of the termination;
  moreover, such termination may be deferred as further described in
  Article VII of this Agreement;

  
	
  iv)

  	
   

  	
  by either party
  upon 10 days written notice in the event the other party loses licensure or
  other governmental authorization necessary to perform this Agreement, or
  fails to have insurance as required under section 4.7 or section 5.2 of this
  Agreement;

  
	
  v)

  	
   

  	
  by United upon 10
  days written notice in the event Facility loses accreditation;

  
	
  vi)

  	
   

  	
  by United, upon 90
  days notice, in the event:

  
	
   

  	
   

  	
  a)

  	
  Facility loses approval for participation
  under United’s credentialing plan, or

  
	
   

  	
   

  	
  b)

  	
  Facility does not successfully complete the
  United’s re-credentialing process as required by the credentialing plan;

  
	
  vii)

  	
   

  	
  by United upon 10
  days written notice in the event there is any change in the controlling
  interest of Facility modifying the percentage ownership interest outlined in
  exhibit 2 to this Agreement.

  

 

8.3          Ongoing
Services to Certain Customers After Termination Takes Effect. 
In the event a Customer is receiving any of the Covered Services, as of
the date the termination takes effect, Facility will continue to render those
Covered Services to that Customer, and this Agreement will continue to apply to
those Covered Services, after the termination takes effect, until the earlier
of: the Covered Services are complete or 30 days after termination.

 

Article IX.

Miscellaneous
Provisions

 

9.1          Entire
Agreement.  This Agreement is the entire agreement
between the parties with regard to the subject matter herein, and supersedes
any prior written or unwritten agreements between the parties or their
affiliates with regard to the same subject matter.

 

9.2          Amendment. 
This Agreement may only be amended in a writing signed by both parties,
except that this Agreement may be unilaterally amended by United upon written
notice to Facility in order to comply with applicable regulatory
requirements.  United will provide at
least 30 days notice of any such regulatory amendment, unless a shorter notice
is necessary in order to accomplish regulatory compliance.

 

9.3          Nonwaiver. 
The waiver by either party of any breach of any provision of this
Agreement shall not operate as a waiver of any subsequent breach of the same or
any other provision.

 

9.4          Assignment. 
This Agreement may not be assigned by either party without the written
consent of the other party, except that this Agreement may be assigned by
United to any of United’s Affiliates.

 

9.5          Relationship
of the Parties.  The sole
relationship between the parties to this Agreement is that of independent
contractors.  This Agreement does not
create a joint venture, partnership, agency, employment or other relationship
between the parties.

 

9.6          No
Third-Party Beneficiaries.  United and
Facility are the only entities with rights and remedies under the Agreement.

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***]
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

 

9.7          Delegation. 
United may delegate (but not assign) certain of its administrative
duties under this Agreement to one or more other entities.  No such delegation will relieve United of its
obligations under this Agreement.

 

9.8          Notice. 
Any notice required to be given under this Agreement shall be in
writing, except in cases in which this Agreement specifically permits
electronic notice, or as otherwise permitted or required in the Protocols.  All written or electronic notices shall be
deemed to have been given when delivered in person, by electronic
communication, by facsimile or, if delivered by first-class United States mail,
on the date mailed, proper postage prepaid and properly addressed to the
appropriate party at the address set forth on the signature portion of this
Agreement or to another more recent address of which the sending party has
received written notice.  Notwithstanding
the previous sentence, all notices of termination of this Agreement by either
party must be sent by certified mail, return receipt requested.  Each party shall provide the other with
proper addresses, facsimile numbers and electronic mail addresses of all designees
that should receive certain notices or communication instead of that party.

 

9.9          Confidentiality. 
Neither party will disclose to a Customer, other health care providers,
or other third parties any of the following information (except as required by
an agency of the government):

 

a) any
proprietary business information, not available to the general public, obtained
by the party from the other party; or

b) the specific reimbursement amounts provided for under this Agreement, except
for purposes of administration of benefits.

 

At least 48 hours
before either party issues a press release, advertisement, or other media
statement about the business relationship between the parties, that party will
give the other party a copy of the material the party intends to issue.

 

Except as
otherwise required by applicable law or stock exchange rule, Facility will not,
and will not permit any of its representative affiliates, representatives or
advisers to, issue or cause the publication of any press release or make any
other public announcement, including, without limitation, any “tombstone” or
other advertisements, with respect to this Agreement, or the business
relationship between the parties, without the consent of United.

 

9.10        Governing
Law.  This Agreement will be governed by and
construed in accordance with the laws of the State of Minnesota, and any other
applicable law.

 

9.11        Regulatory
Appendices.  One or more regulatory appendix may be
attached to this Agreement, setting forth additional provisions included in
this Agreement in order to satisfy regulatory requirements under applicable
law.  These regulatory appendices, and
any attachments to them, are expressly incorporated into this Agreement and are
binding on the parties to this Agreement. 
In the event of any inconsistent or contrary language between a
regulatory appendix and any other part of this Agreement, including but not
limited to appendices, amendments and exhibits, the regulatory appendix will
control, to the extent it is applicable.

 

9.12        Severability. 
Any provision of this Agreement that is unlawful, invalid or
unenforceable in any situation in any jurisdiction shall not affect the
validity or enforceability of the remaining provisions of this Agreement or the
lawfulness, validity or enforceability of the offending provision in any other
situation or jurisdiction.

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***]
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

 

9.13        Survival. 
Sections 4.10, 6.7, 6,8, Article VII and sections 8.3 and 9.9 of
this Agreement will survive the termination of this Agreement

 

9.14        Data
Services.  The parties incorporate by reference the Data
Services Appendix attached to this Agreement.

 

THIS
AGREEMENT CONTAINS A BINDING ARBITRATION PROVISION THAT MAY BE ENFORCED BY
THE PARTIES.

 

	
  [Facility]

  	
   

  	
  Address to be used for giving notice to

  Facility under the Agreement:

  
	
   

  	
   

  	
   

  
	
  Signature

  	
  /s/ Frank Ruderman

  	
   

  	
  Street

  	
  839 Mitten Road

  
	
   

  	
   

  	
   

  
	
  Print Name

  	
  Frank Ruderman

  	
   

  	
  City

  	
  Burlingame

  
	
   

  	
   

  	
   

  
	
  Title

  	
  President

  	
   

  	
  State

  	
  CA

  	
   

  	
  Zip Code

  	
  94010

  
	
   

  	
   

  	
   

  	
   

  
	
  Date

  	
  10/30/07

  	
   

  	
  E-mail

  	
  fruderman@bhlinc.com

  

 

United
HealthCare Insurance Company, on behalf of itself, [United Healthcare of
State], and its other affiliates [including without limitation those affiliates
listed in Exhibit 1], as signed by its authorized representative:

 

	
  Signature

  	
  /s/ Edward Novinski

  	
   

  	
  Signature

  	
  /s/ Elena McFann

  
	
   

  	
   

  	
   

  
	
  Print Name

  	
  Edward Novinski

  	
   

  	
  Print Name

  	
  Elena McFann

  
	
   

  	
   

  	
   

  
	
  Title

  	
  SVP, Network Mgmt

  	
   

  	
  Title

  	
  VP, Network Management

  
	
   

  	
   

  	
   

  	
   

  
	
  Date

  	
  10/31/07

  	
   

  	
  Date

  	
  10/30/07

  
	
   

  	
   

  
	
   

  	
  [Address to be used for giving notice to
  United under the Agreement]

  
	
   

  	
   

  
	
   

  	
  Street

  	
  5901 Lincoln Dive MN012-5203

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  City

  	
  Edina

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  State

  	
  MN

  	
   

  	
  Zip Code

  	
  55436

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  IN THE EVENT THIS AGREEMENT INCLUDES TWO
  SIGNATURE BLOCKS FOR UNITED, THIS AGREEMENT IS NOT BINDING UPON UNITED UNLESS
  EACH OF THE TWO UNITED SIGNATURE BLOCKS ARE EXECUTED.

  
													

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***] 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.

 

15

 

	
  x

  	
   

  	
  Appendix 1:
  Facility Location and Service Listings

  
	
  x

  	
   

  	
  Appendix 2:
  Benefit Plan Descriptions

  
	
  x

  	
   

  	
  Appendix 3:
  Additional Protocols

  
	
  x

  	
   

  	
  State Regulatory
  Requirements Appendix (list all states as applicable)

  

 

Alabama,
Alaska, Arizona, Arkansas

California, Colorado, Connecticut

Delaware, District of Columbia

Florida, Georgia, Hawaii

Idaho, Illinois, Indiana, Iowa

Kansas, Kentucky, Louisiana

Maine, Maryland, Massachusetts

Michigan, Mississippi, Missouri, Montana

Nebraska, Nevada, New Hampshire

New Jersey, New Mexico, New York

North Carolina, Ohio, Oklahoma, Oregon

Pennsylvania, Rhode Island, South Carolina

Tennessee, Texas, Utah

Vermont, Virginia, Washington

West Virginia, Wisconsin, Wyoming

 

	
  x

  	
   

  	
  Appendix 4
  Payment Appendices

  
	
  x

  	
   

  	
  Medicare
  Advantage Regulatory Requirements Appendix

  
	
  o

  	
   

  	
  Medicare
  Advantage Payment Appendix

  
	
  o

  	
   

  	
  Medicare
  Select Payment Appendix

  
	
  o

  	
   

  	
  Medicaid
  Regulatory Requirements Appendix

  
	
  o

  	
   

  	
  Medicaid
  Payment Appendix

  
	
  x

  	
   

  	
  Performance
  Standards and Guaranties Appendix

  
	
  x

  	
   

  	
  Data
  Services Appendix

  
	
  o

  	
   

  	
  Exhibit 1
  Affiliates

  
	
  x

  	
   

  	
  Exhibit 2
  Attestation of Ownership

  
	
  o

  	
   

  	
  Other

  

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***] 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.

 

16

 

IMPORTANT
NOTE: This Agreement applies to the Covered Services provided at the Facility
locations with Taxpayer Identification Numbers (TIN) and specified markets
listed below. Facility acknowledges its obligation under Sections 3.1 and 4.8
to promptly report any change in Facility’s name or TIN. Failure to do so may
result in denial of claims or incorrect payment. Any additional names, TINs,
service types or locations not listed below will become subject to this
Agreement only upon the prior written agreement of the parties.

 

Appendix
1

Facility Location and Service Listings

 

[Berkeley Heart Lab, Inc.]

 

BILLING ADDRESS

 

[Berkeley
Heart Lab]

[839 Mitten Rd]

[Burlingame, CA 94010]

[330685751]

 

[FACULTY LOCATIONS]

 

	
  [Facility Name]

  	
  [Facility Name]

  	
  [Facility Name]

  
	
  [Street Address]

  	
  [Street Address]

  	
  [Street Address]

  
	
  [City, State Zip]

  	
  [City, State Zip]

  	
  [City, State Zip]

  
	
  [Phone #]

  	
  [Phone #]

  	
  [Phone #]

  
	
  [TIN]

  	
  [TIN]

  	
  [TIN]

  

 

[OTHER SERVICE LOCATIONS]

 

	
  [Facility Name]

  	
   

  
	
  [Street Address]

  	
  [Street Address]

  
	
  [City, State Zip]

  	
  [City, State Zip]

  
	
  [Phone #]

  	
  [Phone #]

  
	
  [TIN]

  	
  [TIN]

  
	
   

  	
   

  
	
  [Facility Name]

  	
   

  
	
  [Street Address]

  	
   

  
	
  [City, State Zip]

  	
   

  
	
  [Phone #]

  	
   

  
	
  [TIN]

  	
   

  
	
   

  	
   

  
	
  [Facility Name]

  	
   

  

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***]
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.

 

17

 

Appendix
2

Benefit Plan Descriptions

 

Facility will
participate in the network of physicians and other health care professionals
and providers established by United (“Participating Providers”) for the Benefit
Plan types described below:

 

	
  •

  	
   

  	
  Benefit Plans where
  Customers are offered a network of Participating Providers and must select a
  Primary Physician. Such Benefit Plans may or may not include an
  out-of-network benefit.

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  Benefit Plans where
  Customers are offered a network of Participating Providers but are not
  required to select a primary physician. Such Benefit Plans may or may not
  include an out-of-network benefit.

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  Benefit Plans where
  Customers are not offered a network of Participating Providers from which
  they may receive Covered Services.

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  [Benefit plans or programs
  serviced by OneNet PPO, LLC]

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  [Benefit Plans sponsored,
  issued or administered by any Payer where the Benefit Plan is intended to
  replace, either partially or in its entirety, the traditional Medicare
  coverage (Medicare Part A and Medicare Part B) issued to beneficiaries by the
  Centers for Medicare and Medicaid Services.]

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  [Medicare Advantage
  Private Fee-For-Service plans.]

  

Facility will not
participate in the network of physicians and other health care professionals
and providers established by United for the Benefit Plan types described below:

	
  •

  	
   

  	
  [Benefit plans or programs
  serviced by OneNet PPO, LLC]

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  [Benefit Plans for
  Medicaid Customers (Note: excluding Medicaid from this Agreement does not
  preclude the parties or their affiliates from having a separate agreement
  pertaining to participation in a Medicaid network).]

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  [Benefit Plans for
  Medicaid Customers]

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  [Benefit Plans for
  workers’ compensation benefit programs]

  
	
   

  	
   

  	
   

  
	
  •

  	
   

  	
  [Benefit Plans for
  Medicare Select.]

  

 

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***] 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.

 

18

 

Appendix 3

PacifiCare Protocols

 

For Customers
enrolled in Benefit Plans issued or administered by a subsidiary of either
PacifiCare Health Plan Administrators, Inc. or PacifiCare Health Systems,
LLC (“PacifiCare Customers”), Facility will be subject to the Protocols
described in or made available through the PacifiCare Provider Policy and
Procedure Manual (“PacifiCare Manual”). When this Agreement refers to the
Administrative Manual or Guide, it is also referring to the PacifiCare Manual.
The PacifiCare Manual will be made available to Facility on line or upon
request. In the event of any conflict between this Agreement or the
UnitedHealthcare Physician, Health Care Professional, Facility and Ancillary
Provider Administrative Guide or other UnitedHealthcare administrative
protocols, and the PacifiCare Manual, in connection with any matter pertaining
to a PacifiCare Customer, the PacifiCare Manual will govern, unless applicable
statutes and regulations dictate otherwise. United may make changes to the
Administrative Manual or Guide or PacifiCare Manual or other administrative
protocols upon 30 days’ electronic or written notice to Facility.

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***]
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.

 

19

 

Representative All-Payer Fee Schedule Sample: [* * *]

 

Unless another
appendix to this agreement applies specifically to a particular Benefit Plan as
it covers a particular customer, the provisions of this appendix apply to
covered services rendered by you to Customers covered by Benefit Plans
sponsored, issued or administered by all participating entities.

 

Unless
specifically indicated otherwise, amounts listed in the fee schedule represent
global fees and may be subject to reductions based on appropriate modifier (for
example, professional and technical modifiers). Any co-payment, deductible or
coinsurance that the Customer is responsible to pay under the Customer’s
Benefit Plan will be subtracted from the listed amount in determining the
amount to be paid by the Payer. The actual payment amount is also subject to
matters described in this Agreement, such as the reimbursement policies. Please
remember that this information is subject to the confidentiality provisions of
this Agreement.

 

[* * *] Reimbursement will be paid according to the schedule listed
below:

 

	
  Type of Service

  	
   

  	
  Primary Fee Source

  	
   

  	
  PCT

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  LAB - PATHOLOGY

  	
   

  	
  Current Year CMS RBRVS (0000000)

  	
   

  	
  [* * *]

  
	
  OFFICE LAB

  	
   

  	
  Current Year CMS Clinical Lab Schedule -
  National Limit

  	
   

  	
  [* * *]

  
	
  CLINICAL LABORATORY

  	
   

  	
  Current Year CMS Clinical Lab Schedule -
  National Limit

  	
   

  	
  [* * *]

  

 

New
Technology:

 

United
acknowledges that Facility may develop and/or provide new technologies and/or
new methodologies during the term of this Agreement. In addition, both parties
acknowledge that there may be other circumstances in which there is no fee in
the fee schedule, or where no relative value units have been established for a
particular service. Facility shall notify United when such new technologies
and/or methodologies are available, or no fee or relative value units have been
established for a particular service and the parties shall develop the fee
and/or relative value units associated with such new technologies and/or
methodologies and/or services.

 

The
methodology for developing new fees or relative value units shall be as
follows:

 

	
  (a)

  	
   

  	
  [* * *]

  
	
   

  	
   

  	
   

  
	
  (b)

  	
   

  	
  [* * *]

  

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][State][Nat’l].08.07

  	
  0507

  

 

[***]
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.

 

20

 

	
  (c)

  	
   

  	
  [* * *]

  
	
   

  	
   

  	
   

  
	
  (d)

  	
   

  	
  [* * *]

  
	
   

  	
   

  	
   

  
	
  (e)

  	
   

  	
  [* * *]

  

 

For reference purposes, the following fee schedules will be used to pay
claims under this agreement:

 

	
  PRODUCTS:

  	
   

  	
  FEE SCHEDULES:

  	
   

  	
  PROVIDER

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  DESCRIPTION

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Commercial

  	
   

  	
  [* * *]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Medicare

  	
   

  	
  [* * *]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  

 

	
  UnitedHealthcare
  Facility Agreement

  	
  Confidential
  and Proprietary

  
	
  UHC/FPA[ANC][Nat’l].08.07[State]

  	
  0807

  

 

[***] 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.

 

21

 

Appendix 4

ATTESTATION
OF BERKELEY HEART LABORATORY

 

State
of California

 

County
of San Mateo

 

Before
me the undersigned Notary appeared Frank Ruderman, who being either known
personally to me and/or presenting proper identification, was duly sworn by me and
testified as follows:

 

(1)           “My name is Frank Ruderman, I am over
the age of 18, fully competent to give this Attestation and have personal
knowledge of the facts stated in it.”

 

(2)           “I hereby certify, that (ENTITY NAME
or NAME OF LAB) has XX% ownership of the (NAME OF THE LAB).”

 

(3)           “I hereby certify that the following
entities have the following percentage ownership of the (NAME OF THE LAB):
(List all entities in joint venture and percentage ownership).”

 

(4)           “I hereby certify that at no time
will any entity control more than the current percentage ownership as set forth
herein of the (NAME THE LAB).”

 

(5)           “I hereby certify that at no time
will the (NAME OF THE LAB) assets, liabilities, revenues and expenses be
consolidated from (NAME OF THE LAB) to any other laboratory or its affiliates.”

 

Further
this Affiant sayeth not.

 

Signed
this          day of
          ,
200    .

 

	
  /s/
  Frank Ruderman

  	
   

  
	
  [Affiant
  signature]

  	
   

  
	
   

  	
   

  
	
  Notary
  Stamp/Certification

  	
   

  
	
   

  	
   

  
	
  October 30,
  2007

  	
   

  
	
  Notary
  Signature

  	
   

  
	
   

  	
   

  
	
  October 30,
  2007

  	
   

  
	
  Date
  of Notary’s Signature

  	
   

  
	
   

  	
   

  
	
  October 15,
  2009

  	
   

  
	
  Expiration
  date of Notary authority

  	
   

  

 

	
  UnitedHealthcare
  Facility Agreement

  	
   

  	
  Confidential and
  Proprietary

  
	
  UHC/FPA[ANC][Nat’l].08.07[State]

  	
   

  	
  0807

  

 

[***] 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.

 

22

 

1 Performance Standards and
Guarantees Appendix

 

	
  Service Area

  	
   

  	
  Performance Guarantee

  	
   

  	
  Criteria for Measurement

  
	
  Result
  Delivery Response Time

  	
   

  	
  [*
  * *]

  	
   

  	
  [*
  * *]

  
	
  Quality

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  
	
  Reporting and Measurement

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  
	
  Billing and Reimbursement

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  

 

	
  UnitedHealthcare
  Facility Agreement

  	
   

  	
  Confidential and
  Proprietary

  
	
  UHC/FPA[ANC][Nat’l].08.07[State]

  	
   

  	
  0807

  

 

[***] 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.

 

23

 

Data Services Appendix

 

Pursuant to Section 9.X
of the Agreement, Ancillary Provider agrees to provide Data, as defined herein,
to United and/or its designated data agency (“Data Agency”) as provided herein
consistent with state and federal law including, but not limited to, the Health
Insurance Portability and Accountability Act of 1996 (“HIPAA”). For this
purpose, “Data” means all information obtained or generated by Ancillary
Provider in the course of or in connection with providing Covered Services
pursuant to the Agreement including, without limitation, results for individual
laboratory test analytes and all other data necessary for United and/or Data
Agency (1) to fulfill their obligations to comply with all state and
federal data collection and reporting requirements, including, but not limited
to, the Health Plan Employer Data and Information Set (“HEDIS”); (2) to
perform their Care CoordinationsSM and quality improvement programs,
including physician performance, pharmaceutical safety, Customer health risks
using predictive modeling and the subsequent development of disease management
programs utilized by United; and (3) to research and benchmark data sets.
Data is Customer specific. Nothing in this Appendix shall preclude United from
establishing an electronic connection to Ancillary Provider’s portal that
houses test ordering and results. United represents and warrants that it has
obtained or caused to be obtained any written Customer consents which are
required by applicable law for the release of Customer-identifiable Data as set
forth in this Appendix.

 

Access
to Data

 

The parties acknowledge and
agree that United shall have access to all Data on an “as needed” basis, as
determined by United, subject to any applicable timing requirements set forth
in the Performance Standards Appendix to the Agreement. During the term of the
Agreement, the request for Data by United will generally involve only those
elements or portions of Data consistent with the “Use of Data” and “Data
Schedule” sections of this Appendix (see below). United shall also have access
to all Data for a one-year period following the date Covered Services were last
provided for a Customer.

 

Provision
of Data

 

Ancillary Provider shall provide
Data to United via a media and in a file layout mutually agreed upon by the
parties. The media may be via tapes, spread sheet documents, or electronic
feeds. Data will be provided to United on a daily basis or some other delivery
interval agreed to by the parties. Upon mutual agreement of the parties, this
Data may also be provided to a Data recipient designated by United, other than
Data Agency. The Data reports and/or electronic feeds will contain information
obtained or generated pursuant to the Agreement during the current delivery
interval. The Data reports and feeds shall not contain information for any
previous delivery intervals unless specifically requested by United.

 

Any electronic feeds will be
in a file layout as determined by Data Agency, subject to Ancillary Provider’s
acceptance which will not be unreasonably withheld or delayed, using the HL7
2.4, HL7 2.4 (XML), CALINX Lab 1.1, or other layout as mutually agreed upon by
the parties. The file layout used to send the Data shall include a Logical
Observation Identifiers, Names and Codes (“LOINC”) identifier, an upper and
lower range of normal values, numeric results, test results and Units for the
laboratory test analytes provided. It is also agreed that there will be joint
cooperation between Ancillary Provider and Data Agency in testing the data
fields in connection with any electronic feeds. Such testing will include, but
not be limited to, the provision of test tapes or files by Ancillary Provider
to Data Agency.

 

In the event Data Agency
identifies a problem with a particular Data file that has been sent by
Ancillary Provider, Ancillary Provider shall provide to Data Agency a corrected
Data file, at no cost to United, within 5 business days of the date Ancillary
Provider received notification of such problem from Data Agency or a mutually
agreed upon date.

 

Ancillary Provider will
supply all analyte results, regardless of type. United represents and warrants
that it shall have security measures in place for its receipt of Data from Ancillary
Provider, and acknowledges and

 

	
  UnitedHealthcare
  Facility Agreement

  	
   

  	
  Confidential and
  Proprietary

  
	
  UHC/FPA[ANC][Nat’l].08.07[State]

  	
   

  	
  0807

  

 

[***] 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.

 

24

 

agrees that United is
responsible for the lawful use by United, Data Agency or other Data recipients
designated by United, of all Data received by them pursuant to this Appendix.

 

Quality
of Data

 

Ancillary Provider hereby
represents and warrants that to the best of its knowledge all Data shall be
accurate and complete, meaning all Data will represent the information received
from the ordering physician and results reported by Ancillary Provider, as
appropriate to the Data request. To the extent required by United, Ancillary
Provider agrees to certify in writing at the time of submission to United, Data
Agency, or other Data recipients designated by United, that all Data is to the
best of its knowledge accurate and complete as defined above. Ancillary
Provider further agrees to hold harmless and indemnify United and Data Agency
or other designees to the extent any fines, penalties, damages, claims,
liabilities or judgments result from Ancillary Provider’s negligence,
misconduct or breach of the warranty set forth in the preceding sentence.
United acknowledges, however, that Ancillary Provider is not responsible for
inaccurate or incomplete information or Data received or obtained from the
ordering physician or any third party, or for any party’s (other than Ancillary
Provider’s) improper use of the Data. Moreover, Ancillary Provider shall not be
responsible for inaccurate or incomplete Customer eligibility information
provided to it. United or its designees shall have the right to audit Ancillary
Provider with regard to the accurateness and completeness of the Data pursuant
to Section 4.10 of the Agreement.

 

Use
of Data

 

During and after the term of
the Agreement, United and/or Data Agency may use, transfer, de-identify and
combine Data and the information derived from that Data consistent with state
and federal law including, but not limited to, HIPAA, (1) to fulfill their
obligations to comply with all state and federal data collection and reporting
requirements for, including but not limited to, the HEDIS; (2) to perform
their Care CoordinationSM and quality improvement programs,
including physician performance, pharmaceutical safety, Customer health risks
using predictive modeling and the subsequent development of disease management
programs utilized by United; and (3) to research and benchmark data sets.
Moreover, United and/or Data Agency shall have the right, to the extent permitted
by applicable law, to sell de-identified Data to any third party. 

 

United, Data Agency, and any
other Data recipients designated by United shall comply with all applicable
privacy laws with respect to their use, transfer, de-identification and combination
of Data.

 

Data
Schedule

 

As of the Effective Date of
the Agreement, Ancillary Provider and United agree to the data services and
specifications set forth below. Ancillary Provider shall be responsible for the
preparation and transfer of the Data.

 

	
  ·

  	
   

  	
  Ancillary
  Provider will supply to Data Agency a daily clinical results data feed for
  all Covered Services provided under this Agreement.

  
	
   

  	
   

  	
   

  
	
  ·

  	
   

  	
  Ancillary
  Provider will supply to Data Agency, upon request of United or Data Agency, a
  clinical results data report for Customers or a particular United Affiliate
  or Payer. These report requests may be specific to test analyte(s).

  
	
   

  	
   

  	
   

  
	
  ·

  	
   

  	
  Ancillary
  Provider will supply to Data Agency, upon request of United or Data Agency,
  any ad hoc report pertaining to Data.

  

 

	
  UnitedHealthcare
  Facility Agreement

  	
   

  	
  Confidential and
  Proprietary

  
	
  UHC/FPA[ANC][Nat’l].08.07[State]

  	
   

  	
  0807

  

 

[***] 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.

 

25

 

United Health Networks

A United Health Group Company

 

BERKELEY HEARTLAB

 

Representative Fee Schedule Sample for : [* *
*] 

Fee amounts as of: 12/01/2007

Report Date: 10/26/2007 *

Site of Service - Linked Schedule ID:

 

	
  CPT

  	
   

  	
  Mod

  	
   

  	
  CPT
  Description

  	
   

  	
  Type of
  Service

  	
   

  	
  Place of

  Service

  	
   

  	
  Fee

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  36415

  	
   

  	
  00

  	
   

  	
  COLLECTION OF VE

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  36416

  	
   

  	
  00

  	
   

  	
  COLLECTION OF CAP

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  80048

  	
   

  	
  00

  	
   

  	
  BASIC METABOLIC

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  80050

  	
   

  	
  00

  	
   

  	
  GENERAL HEALTH P

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  80053

  	
   

  	
  00

  	
   

  	
  COMPREHENSIVE ME

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  80061

  	
   

  	
  00

  	
   

  	
  LIPID PANEL

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  Al

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  80076

  	
   

  	
  00

  	
   

  	
  HEPATIC FUNCTION

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  81000

  	
   

  	
  00

  	
   

  	
  UA DIPSTIK/TABLE

  	
   

  	
  OFFICE LAB

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  81001

  	
   

  	
  00

  	
   

  	
  UA DIP STICK/TAB

  	
   

  	
  OFFICE LAB

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  81002

  	
   

  	
  00

  	
   

  	
  UA DIP STIK/TABL

  	
   

  	
  OFFICE LAB

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  82270

  	
   

  	
  00

  	
   

  	
  BLD OCLT PROXIDA

  	
   

  	
  OFFICE LAB

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  82670

  	
   

  	
  00

  	
   

  	
  ESTRADIOL

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  83036

  	
   

  	
  00

  	
   

  	
  HGB GLYCOSYLATED

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  84153

  	
   

  	
  00

  	
   

  	
  PROSTATE SPECIFI

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  84439

  	
   

  	
  00

  	
   

  	
  THYROXINE; FREE

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  84443

  	
   

  	
  00

  	
   

  	
  THYROID STIMULAT

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  85025

  	
   

  	
  00

  	
   

  	
  BLD COUNT; CMPL

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  85610

  	
   

  	
  00

  	
   

  	
  PROTHROMBIN TIME

  	
   

  	
  OFFICE LAB

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88580

  	
   

  	
  00

  	
   

  	
  SKIN TEST; TUBER

  	
   

  	
  OFFICE LAB

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  87070

  	
   

  	
  00

  	
   

  	
  CULT BACT: NO UR

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  87081

  	
   

  	
  00

  	
   

  	
  CULT PRESUMP PAT

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  87430

  	
   

  	
  00

  	
   

  	
  INF AGT-IMMUNOAS

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  87491

  	
   

  	
  00

  	
   

  	
  INF AGT-DNA/RNA;

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  87880

  	
   

  	
  00

  	
   

  	
  INF AGT-IMMUNOAS

  	
   

  	
  OFFICE LAB

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88142

  	
   

  	
  00

  	
   

  	
  CYTPTH CERV/VAG;

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88173

  	
   

  	
  00

  	
   

  	
  EVAL FINE NEEDL

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88173

  	
   

  	
  26

  	
   

  	
  EVAL FINE NEEDL

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88173

  	
   

  	
  TC

  	
   

  	
  EVAL FINE NEEDL

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88304

  	
   

  	
  00

  	
   

  	
  LEVEL III - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88304

  	
   

  	
  26

  	
   

  	
  LEVEL III - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88304

  	
   

  	
  TC

  	
   

  	
  LEVEL III - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88305

  	
   

  	
  00

  	
   

  	
  LEVEL IV - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88305

  	
   

  	
  26

  	
   

  	
  LEVEL IV - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88305

  	
   

  	
  TC

  	
   

  	
  LEVEL IV - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88307

  	
   

  	
  00

  	
   

  	
  LEVEL V - SURG PA

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88307

  	
   

  	
  26

  	
   

  	
  LEVEL V - SURG PA

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88307

  	
   

  	
  TC

  	
   

  	
  LEVEL V - SURG PA

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88309

  	
   

  	
  00

  	
   

  	
  LEVEL VI - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88309

  	
   

  	
  26

  	
   

  	
  LEVEL VI - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88309

  	
   

  	
  TC

  	
   

  	
  LEVEL VI - SURG

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88312

  	
   

  	
  00

  	
   

  	
  SPECIAL STAINS;

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88312

  	
   

  	
  26

  	
   

  	
  SPECIAL STAINS;

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88312

  	
   

  	
  TC

  	
   

  	
  SPECIAL STAINS;

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88331

  	
   

  	
  00

  	
   

  	
  PATH CONS-SURG; 1

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88331

  	
   

  	
  26

  	
   

  	
  PATH CONS-SURG; 1

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88331

  	
   

  	
  TC

  	
   

  	
  PATH CONS-SURG; 1

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88342

  	
   

  	
  00

  	
   

  	
  IMMUNOHISTOCHEMI

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88342

  	
   

  	
  26

  	
   

  	
  IMMUNOHISTOCHEMI

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  88342

  	
   

  	
  TC

  	
   

  	
  IMMUNOHISTOCHEMI

  	
   

  	
  LAB – PATHOLOGY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Q0091

  	
   

  	
  00

  	
   

  	
  SCR PAP SMER; OB

  	
   

  	
  CLINICAL LABORATORY

  	
   

  	
  All

  	
   

  	
  $

  	
  [***]

  	
   

  

 

Last Routine Maintenance
Update: 10-01-2007

Default Percent of Charges: [***]

Anesthesia Conversion Factor:
[***]

Anesthesia Rounding Option: [***]

 

Unless specifically indicated
otherwise, amounts listed in the fee schedule represent global fees and may be
subject to reductions based on appropriate modifier (for example, professional
and technical modifiers).  Any
co-payment, deductible or coinsurance that the customer is responsible to pay
under the customer’s benefit contract will be subtracted from the listed amount
in determining the amount to be paid by the payer.  The actual payment amount is also subject to
matters described in this agreement, such as the payment policies.  Please remember that this information is
subject to the confidentiality provisions of this agreement

 

* Note:  Maintenance to this fee schedule occurs
routinely and may still occur after the report date for the fee amounts
selected.

 

Confidential and
Proprietary          Not for Distribution
to Third Parties

 

[***] 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.

 

1

 

United
Health Networks

A United
Health Group Company

 

Additional Information About Your Fee
Schedule

 

[* * *]

 

The purpose of
this document is to provide additional information about this fee schedule,
including clarity about the fee sources used to derive fees and the type of
routine maintenance changes that you can expect.

 

Primary Fee Source

 

The primary
fee source is the main fee source used as the basis for deriving the fee within
each category of codes. For instance, if the fee schedule for a given category
of codes is derived by applying a particular conversion factor to the relative
value units (RVUs) in the CMS fee schedule, those CMS relative value units are
the primary fee source.

 

Alternate (Gap-Fill) Fee Source

 

Alternate (or “gap
fill”) fee sources are used to fill gaps in the primary fee sources. For
example, if a new CPT code has been created within the category of codes
discussed above, and CMS has not yet established an RVU value for that code, we
use one of the sources that exist within the industry to fill that gap, such as
but not limited to Ingenix Essential RBRVS and CMS Part B Carriers. For
that CPT code, we adopt the RVU value established by the gap fill-fee source,
and determine the fee schedule amount for that CPT code by applying to the
gap-fill RVU the same conversion factor that we apply to the CMS RVU for those
CPT codes that have CMS RVUs. At such time in the future as CMS publishes its
own RVU value for that CPT code, we would begin using the primary fee source,
CMS, to derive the fee for that code and no longer use the alternate source.

 

Percent of Charge Default

 

In the event
that a fee is not sourced by either the primary or alternate fee source, such
as services submitted using unclassified or miscellaneous codes, the codes are
subject to correct coding review and may be priced at the default Percent of
Charge indicated in the attached document(s).

 

Fee Source Links

 

·                  CMS Relative Values and Fee
Schedules: www.cms.hhs.gov

·                  MICROMEDEX Red Book:
www.micromedex.com

·                  Ingenix Essential RBRVS:
www.ingenixonline.com

·                  American Society of
Anesthesiologists: www.asahq.org

 

Site of Service

 

This fee
schedule applies no variation in pricing based on where the service is
performed.

 

Routine Maintenance

 

United
routinely updates its fee schedule in an effort to stay abreast of current
coding practices widely used in the health care industry; in response to price
changes for immunizations and injectable medications; and to remain in
compliance with the intent of the contractual agreement. Routine maintenance
occurs when United mechanically incorporates revised information created by a
third party that is the source for a portion of the fee schedule. United will
not generally attempt to communicate routine maintenance of this nature and
will generally implement updates to be effective within 90 days from the date
of final publication from one of our primary or alternate fee sources. Providers
may expect the following types of fee updates to their fee schedules:

 

a. Changes to Relative Value Units,
Conversion Factors, or Flat Rate Fees

 

This fee schedule follows a “Current
Year” construction methodology. It is generally intended to remain current with
RVU, Conversion Factor, and Flat Rate Fee (non-RVU based fees such as Durable
Medical Equipment fees) changes as the basis for deriving fees. As such,
changes published by the primary and/or alternate fee sources will similarly be
reflected in this fee schedule.

 

Last Routine Maintenance
Update: 10-01-2007

Default Percent of Charges: [***]

Anesthesia Conversion Factor: [***]

Anesthesia Rounding Option: [***]

 

Unless specifically indicated otherwise, amounts listed
in the fee schedule represent global fees and may be subject to reductions
based on appropriate modifier (for example, professional and technical
modifiers).  Any co-payment, deductible
or coinsurance that the customer is responsible to pay under the customer’s
benefit contract will be subtracted from the listed amount in determining the
amount to be paid by the payer.  The
actual payment amount is also subject to matters described in this agreement,
such as the payment policies.  Please
remember that this information is subject to the confidentiality provisions of
this agreement.

 

* Note: 
Maintenance to this fee schedule occurs routinely and may still occur
after the report date for the fee amounts selected.

 

	
  Confidential and Proprietary

  	
  Not for Distribution to Third Parties

  

 

[***] 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.

 

2

 

Additional Information About Your Fee
Schedule

 

[* * *]

 

b. Price Changes for Immunizations and
Injectable Medications

 

United routinely updates its
fee schedule in response to price changes for immunizations and injectable
medications published by the primary and/or alternate fee sources. United
currently utilizes CMS Drug Pricing and Thomson Micromedex Red Book AWP as its
primary fee sources. Fees are generally updated on a calendar quarter basis
within 90 days from the date of final publication but with an effective date of
the first day of the quarter following publication. In the event that an
Average Wholesale Price (AWP) or an Average Sales Price (ASP) has not yet been
published by Red Book or CMS for a particular injectable drug, UnitedHealthcare
may develop and implement gap-fill fees using available fee information,
including NDC-based pricing, or other available national fee sources. Once Red
Book and CMS do publish a fee for the drug, the AWP or ASP fee will replace the
gap-fill fee at the time of the next quarterly fee schedule update.

 

c. CPT/HCPCS

 

United routinely updates its
fee schedule in response to additions, deletions, and changes to CPT codes by
the American Medical Association; HCPCS codes by the Centers for Medicaid and
Medicare Services; and in response to similar changes (additions and revisions)
to other service coding and reporting conventions that are widely used in the
health care industry. Ordinarily, United’s fee schedule is updated using the
original construction methodology along with the then-current RVU of the
published CPT code.

 

United is
committed to providing transparency related to our fee schedules. If you have
questions about this fee schedule, please contact Network Management at the
address and phone number on your network participation agreement or you may use
our fee schedule look-up function on the web at www.unitedhealthcareonline.com
or contact our Voice Enabled Telephonic Self Service line at (877) 842-3210.

 

Last Routine Maintenance
Update: 10-01-2007

Default Percent of Charges: [***]

Anesthesia Conversion Factor: [***]

Anesthesia Rounding Option: [***]

 

Unless specifically indicated otherwise, amounts listed
in the fee schedule represent global fees and may be subject to reductions
based on appropriate modifier (for example, professional and technical
modifiers).  Any co-payment, deductible
or coinsurance that the customer is responsible to pay under the customer’s
benefit contract will be subtracted from the listed amount in determining the
amount to be paid by the payer.  The actual
payment amount is also subject to matters described in this agreement, such as
the payment policies.  Please remember
that this information is subject to the confidentiality provisions of this
agreement.

 

* Note: 
Maintenance to this fee schedule occurs routinely and may still occur
after the report date for the fee amounts selected.

 

	
  Confidential and Proprietary

  	
  Not for Distribution to Third Parties

  

 

[***] 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.

 

3

 

Ancillary Provider Participation Agreement

Medicare Advantage Regulatory Appendix

 

The provisions
contained in this Appendix supplement the Ancillary Provider Participation
Agreement between Ancillary Provider and United (the “Agreement’). Because
Ancillary Provider has agreed to provide Covered Services to Medicare Customers
who receive their coverage under Medicare Advantage contracts between the
Centers for Medicare and Medicaid Services (“CMS”) and United or other Payers
(collectively “Medicare Advantage Plans’), applicable Medicare Advantage
regulations and CMS guidelines require that the provisions contained in this
Appendix be part of the Agreement. For Medicare Advantage Plans, this Appendix
supersedes any inconsistent provisions that may be found elsewhere in the
Agreement.

 

·                  Data. Ancillary
Provider shall cooperate with United in its efforts to report to CMS all
statistics and other information related to its business, as may be requested
by CMS.  Ancillary Provider shall send to
United all encounter data and other Medicare program-related information as may
be requested by United, within the timeframes specified and in a form that
meets Medicare program requirements. By submitting encounter data to United,
Ancillary Provider represents to United, and upon United’s request Ancillary
Provider shall certify in writing, that the data is accurate and complete,
based on Ancillary Provider’s best knowledge, information and belief. If any of
this data turns out to be inaccurate or incomplete, according to Medicare
Advantage rules, United may withhold or deny payment to Ancillary Provider.

 

·                  Policies.
Ancillary Provider shall cooperate and comply with all of United’s policies and
procedures, credentialing plan and provider administrative manual.

 

·                  Payment. United
shall promptly process and pay Ancillary Provider’s claim no later than 60 days
after United receives all appropriate information as described in United’s
administrative procedures. If Ancillary Provider is responsible for making
payment to subcontracted providers, Ancillary Provider shall pay them within
this same timeframe.

 

·               Customer Protection.
Ancillary Provider agrees that in no event, including but not limited to,
non-payment by United or an intermediary, insolvency of United or an
intermediary, or breach by United of the Agreement, shall Ancillary Provider
bill, charge, collect a deposit from, seek compensation, remuneration or
reimbursement from, or have any recourse against any Customer or person (other
than United or an intermediary) acting on behalf of the Customer for Covered
Services provided pursuant to the Agreement. 
This provision does not prohibit Ancillary Provider from collecting
copayments, coinsurance, or fees for services not covered under the Customer’s
Benefit Plan and delivered on a fee-for-service basis to the Customer. This
provision does not prohibit Ancillary Provider and a Customer from agreeing to
continue services solely at the expense of the Customer, as long as Ancillary
Provider has clearly informed the Customer that the Benefit Plan may not cover
or continue to cover a specific service or services.

 

In the event of United’s or an
intermediary’s insolvency or other cessation of operations or termination of
United’s contract with CMS, Ancillary Provider shall continue to provide
Covered Services to a Customer through the later of the period for which
premium has been paid to United on behalf of the Customer, or, in the case of
Customers who are hospitalized as of such period or date, until the Customer’s
discharge. Covered Services for a Customer confined in an inpatient facility on
the date of insolvency or other cessation of operations shall continue until
the Customer’s continued confinement in an inpatient facility is no longer
medically necessary.

 

This provision shall be
construed in favor of the Customer, shall survive the termination of the
Agreement regardless of the reason for termination, including United’s
insolvency, and shall supersede any oral or

 

[***] 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.

 

 

written contrary agreement
between Ancillary Provider and a Customer or the representative of a Customer
if the contrary agreement is inconsistent with this provision.

 

For the purpose of this
provision, an “intermediary” is a person or entity authorized to negotiate and
execute the Agreement on behalf of Ancillary Provider or on behalf of a network
through which Ancillary Provider elects to participate.

 

·                  Eligibility.
Ancillary Provider agrees to immediately notify United in the event Ancillary
Provider is or becomes disbarred, excluded, suspended, or otherwise determined
to be ineligible to participate in federal health care programs. Ancillary
Provider shall not employ or contract with, with or without compensation, any
individual or entity that has been disbarred, excluded, suspended or otherwise
determined to be ineligible to participate in federal health care programs.

 

·                  Laws. The
parties shall comply with all applicable Medicare laws, regulations and CMS
instructions and shall cooperate with the other’s efforts to comply. Ancillary
Provider shall also cooperate with United in its efforts to comply with its
contract with CMS.

 

·                  Records. The
Secretary of Health and Human Services, the Comptroller General and United
shall have the right to audit, evaluate and inspect any books, contracts,
medical records, patient care documentation and other records belonging to
Ancillary Provider that pertain to the Agreement and other program-related
matters deemed necessary by the person conducting the audit, evaluation, or
inspection. This right shall extend through 10 years from the later of the last
day of a CMS contract period or completion of any audit, or longer in certain
instances described in the applicable Medicare Advantage regulations. Ancillary
Provider shall make its premises, facilities and equipment available for these
activities. Ancillary Provider shall maintain medical records in an accurate
and timely manner. Ancillary Provider shall ensure that Customers have timely
access to medical records and information that pertain to them. The parties
shall safeguard the privacy of any health information that identifies a Customer
and abide by all federal and state laws regarding privacy, confidentiality and
disclosure of medical records and other health and Customer information.

 

·                  Accountability.
Ancillary Provider agrees that United oversees and is accountable to CMS for
any responsibilities that are contained in its contract with CMS, including
those that United may delegate to Ancillary Provider or others. Any
responsibilities that are delegated must be specified in a written arrangement
with the other party. The arrangement must include any reporting requirements,
a right of revocation, performance monitoring by United, ongoing review,
approval and auditing of credentialing processes, if applicable, and compliance
with all applicable Medicare laws, regulations and CMS instructions.

 

·                  Subcontracts.
If Ancillary Provider has subcontract arrangements with other providers to
deliver Covered Services to United’s Customers, Ancillary Provider shall ensure
that its contracts with those subcontracted providers contain all of the
provisions in this Appendix and shall provide proof of such to United upon
request.

 

[***] 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.

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