EXHIBIT 10.41

COLLABORATION AGREEMENT

between

MONOGRAM BIOSCIENCES, INC.

and

PFIZER INC.

Dated as of May 5, 2006

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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1.   Definitions    1   1.1   Additional Facility    1   1.2   Action    2   1.3
  Affiliate    2   1.4   Agreement    2   1.5   Anticipated Launch Date    2  
1.6   Applicable Reimbursement Amount    2   1.7   Arrange for Delivery    2  
1.8   Assay    2   1.9   Business Day    2   1.10   Change of Control    2  
1.11   CLIA    2   1.12   CMS    2   1.13   Code    2   1.14   Collaboration
Security Agreement    2   1.15   Commercial Assay    3   1.16   Commercially
Reasonable Efforts    3   1.17   Consolidator Performance Standards    3   1.18
  Continuation Remedy    3   1.19   Continuation Remedy Term    3   1.20   Costs
of Services    3   1.21   Costs of Services Cap    3   1.22   Costs of Services
Estimate    3   1.23   Cost of Services True-Up Amount    3   1.24   Costs of
Services Reconciliation    3   1.25   Coverage    3   1.26   CPT    3   1.27  
Customer    3   1.28   Diligent Efforts    3   1.29   DOJ    3   1.30  
Effective Date    3   1.31   Encumbrance    3   1.32   Established Country    4
  1.33   Established Assay Criteria    4   1.34   Qualifying Samples    4   1.35
  Ex-US Country    4   1.36   Ex-US Territory    4   1.37   FDA    4   1.38  
FTC    4   1.39   GAAP    4   1.40   Governmental Approval    4   1.41  
Governmental Authority    4   1.42   IND    4   1.43   Indemnified Party    5  
1.44   Indemnifying Party    5   1.45   Infrastructure Plan    5

 

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  1.46    ISC    5   1.47    JSC    5   1.48    Launch    5   1.49    Launch
Date    5   1.50    Laws    5   1.51    Losses    5   1.52    Major Markets    5
  1.53    Medicare Allowable Amount    5   1.54    Monogram    5   1.55   
Monogram Confidential Information    5   1.56    Monogram Copyrights    5   1.57
   Monogram Facility    6   1.58    Monogram Intellectual Property    6   1.59
   Monogram Patent Rights    6   1.60    Monogram Technology    6   1.61   
Monogram Trademarks    6   1.62    National Limitation Amount    6   1.63    NDA
   6   1.64    Note    6   1.65    Note Agreement    6   1.66    Parties    6  
1.67    Patent Rights    6   1.68    Patient    7   1.69    Performance
Standards; Certain Breach Remedies    7   1.70    Person    7   1.71    Pfizer
   7   1.72    Pfizer Agent    7   1.73    Pfizer Confidential Information    7
  1.74    Pfizer Facility    7   1.75    Pfizer Facility Term    7   1.76   
Pfizer Product    7   1.77    Pfizer Technology    8   1.78    Privacy
Regulations    8   1.79    Reimbursement Approval    8   1.80    Regulatory
Approval    8   1.81    Regulatory Authority    8   1.82    Regulatory Filing   
8   1.83    Representatives    8   1.84    Sample    8   1.85    Sample Handling
Guidelines    8   1.86    Senior Executive    8   1.87    SOP    8   1.88   
Successful Test    9   1.89    Tangible Material    9   1.90    Technology    9
  1.91    Term    9

 

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   1.92    Third Party    9    1.93    Third Party Claim    9    1.94    US
Territory    9    1.95    Construction.    9 2.      Supply of Assay in the US
Territory    9    2.1    US Territory Supply    9    2.2    Reimbursement
Responsibility    9    2.3    Fulfillment Standards for the US Territory    10
   2.4    Supply of Other Assays.    10 3.    Supply of Assay In the Ex-US
Territory    11    3.1    Ex-US Supply    11    3.2    Reimbursement
Responsibility    11    3.3    Regulatory Responsibility    11    3.4    Sales
and Marketing Responsibility    11    3.5    Compensation.    12 4.   
Governance Structure of the Assay Collaboration.    13    4.1    Joint Steering
Committee.    13    4.2    Decision-Making Authority.    13    4.3    Meetings
   14    4.4    Minutes    14    4.5    JSC Functions and Powers    15    4.6   
Independence    16 5.    Monogram’s Ex-US Infrastructure and Operating Costs.   
16    5.1    Ex-US Country Infrastructure    16    5.2    Monogram
Infrastructure Roles and Responsibilities.    16    5.3    Infrastructure Plan
Implementation Process.    17    5.4    Front End Transfers    18    5.5   
Logistic Responsibility in Ex-US Countries    18    5.6    Employees;
Contractors    18    5.7    Ex-US Infrastructure Costs and Operating Costs    18
   5.8    Payments    19 6.    Invoicing and Payments    19    6.1    Invoicing
   19    6.2    Payment Method    19    6.3    Taxes.    19    6.4    Interest
   20    6.5    Advances    20 7.    Pfizer and Customer Education.    20    7.1
   Pfizer Education    20    7.2    Customer Education    20    7.3   
Materials; Call Center    21

 

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8.    Regulatory Affairs; Compliance with Law.    21    8.1    Regulatory
Filings and Approvals.    21    8.2    Compliance with Law.    21    8.3   
Licensure    22    8.4    Excluded Provider    22 9.    Ownership of Materials
and Intellectual Property    22 10.    Confidentiality    23    10.1   
Treatment of Confidential Information    23    10.2    Authorized Disclosure   
23    10.3    Publicity    24    10.4    Data Ownership; Publications    24   
10.5    Agreement Filing    25 11.    Additional Or Pfizer Testing Facility   
25    11.1    Establishment of Additional Testing Facility    25    11.2   
Operation of Additional Testing Facility.    26    11.3    Reimbursement    26
   11.4    Abandonment    27    11.5    Monogram Option    27    11.6   
Alternative Arrangements    27 12.    Performance Standards; Certain Breach
Remedies    27    12.1    Forecasting.    27    12.2    Performance Standards   
28    12.3    Pfizer Access in event of Material Breach    28    12.4    Pfizer
Remedy for Breach.    28 13.    Intellectual-Property License.    29    13.1   
License to Pfizer    29 14.    Training of Pfizer Personnel in the Assay;
Materials and Documentation transfer.    30 15.    Records; Other Assay
Limitation.    31    15.1    Records; Audits.    31    15.2    Other Assay
Limitation    31 16.    Term; Termination.    31    16.1    Term    31    16.2
   Termination Upon Exercise of Continuation Remedy by Pfizer    31    16.3   
Termination at Will    31    16.4    Monogram Termination Right    32    16.5   
Other Termination Rights    32    16.6    Effect of Termination.    32 17.   
Representations and Warranties    33    17.1    Corporate Representations and
Warranties    33

 

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   17.2    Additional Representations and Warranties of Monogram    34 18.   
Indemnities    35    18.1    Mutual Indemnification.    35    18.2   
Indemnification Procedures.    36    18.3    Exclusive Remedy    37    18.4   
Dispute Resolution    37 19.    Miscellaneous    37    19.1    Insurance    37
   19.2    Non-Exclusivity    37    19.3    Costs, Expenses    38    19.4    No
Finders’ Fees    38    19.5    Amendment and Waivers    38    19.6    Successors
and Assigns.    38    19.7    Governing Law    38    19.8    Severability    39
   19.9    Entire Agreement    39    19.10    Notices    39    19.11    Titles
and Headings    40    19.12    Counterparts    40    19.13    Facsimile
Signatures    40    19.14    Further Assurances    40    19.15    Third Parties
   40    19.16    Force Majeure    40

 

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COLLABORATION AGREEMENT

THIS COLLABORATION AGREEMENT (the “Agreement”) is entered into as of May 5, 2006
(“Effective Date”) between MONOGRAM BIOSCIENCES, INC., a Delaware corporation
with its offices at 345 Oyster Point Boulevard, South San Francisco, California
94080 (“Monogram”), and PFIZER INC., a Delaware corporation with its offices at
235 East 42nd Street, New York, New York 10017 (“Pfizer”). Monogram and Pfizer
are referred to herein individually as a “Party” or collectively as the
“Parties.”

RECITALS

WHEREAS, Pfizer is engaged in the business of discovering, developing and
commercializing pharmaceutical products, and is currently developing maraviroc,
a novel CCR5 antagonist for the treatment of HIV;

WHEREAS, Monogram has developed a proprietary tropism assay for use in analyzing
the HIV virus in patients, and is currently conducting such assays in connection
with clinical trials of Pfizer pursuant to a Master Services Agreement (“Master
Services Agreement”), dated as of November 14, 2002;

WHEREAS, concurrently with the execution of this Agreement, the Parties are
entering into a Security Agreement (“Collaboration Security Agreement”), dated
as of the date hereof, pursuant to which Monogram will grant to Pfizer a
security interest in certain of its assets to secure the performance of
Monogram’s obligations hereunder;

WHEREAS, concurrently with the execution of this Agreement, the Parties are
entering into a Note Purchase Agreement (“Note Agreement”), dated as of the date
hereof, pursuant to which Pfizer will purchase, subject to the terms and
conditions set forth therein, for $25 million a convertible promissory note
issued by Monogram (the “Note”); and

WHEREAS, Pfizer and Monogram wish to enter into a non-exclusive agreement
regarding the supply of Monogram’s assay in the US Territory and the expansion
of commercial availability of such assay into the countries of the Ex-US
Territory (as defined below) where maraviroc may be Launched (as defined below).

NOW, THEREFORE, in consideration of the foregoing and the covenants and promises
contained in this Agreement and the Note Agreement, the Parties agree as
follows:

1. DEFINITIONS

1.1 “Additional Facility” means a testing facility established for the sole
purpose of performing the Assay in the western United States (i) that contains
all physical assets required to perform the Assay in substantially the same
manner as it is performed at the Monogram Facility as of the Effective Date,
(ii) in which Pfizer is entitled to exercise the license rights set forth in
Section 13.1, and (iii) that possesses all Regulatory Approvals to conduct such
activity in such location.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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1.2 “Action” means any order, writ, injunction, judgment, fine, action, claim,
suit, arbitration, subpoena or proceeding by or before any court or grand jury,
any Governmental Authority or arbitration tribunal.

1.3 “Affiliate” means, with respect to any Person, another Person that directly
or indirectly through one or more intermediaries, controls, is controlled by, or
is under common control with, such first Person, where “control” means the
possession, directly or indirectly, of the power to direct or cause the
direction of the management policies of a Person, whether through the ownership
of voting securities, by contract, as trustee or executor or otherwise. For the
avoidance of doubt, neither Party shall be deemed to be an Affiliate of the
other.

1.4 “Agreement” has the meaning assigned to it in the preamble.

1.5 “Anticipated Launch Date” means the date that Pfizer in good faith has
estimated that the Launch Date for the Pfizer Product will occur in a specific
country.

1.6 “Applicable Reimbursement Amount” means the Medicare Allowable Amount or
National Limitation Amount (as applicable) in effect at such time.

1.7 “Arrange for Delivery” means making arrangements with couriers,
consolidation laboratories or reference laboratories for pick-up of Samples from
Third Parties and their delivery to the Monogram Facility.

1.8 “Assay” means Monogram’s proprietary phenotypic Co-receptor tropism
diagnostic assay, and improvements, enhancements, refinements and modifications
thereon, but excluding second-generation assays.

1.9 “Business Day” means any day on which banks are required to be open both in
the City of New York and San Francisco.

1.10 “Change of Control” has the meaning assigned to it in the Note.

1.11 “CLIA” means the Clinical Laboratory Improvement Amendments of 1988, as it
may be amended from time to time.

1.12 “CMS” means the United States Centers for Medicare and Medicaid Services
(formerly known as the Health Care Financing Administration).

1.13 “Code” or “Codes” means the Code on Interactions with Healthcare
Professionals promulgated by the Pharmaceutical Research and Manufacturers of
America (PhRMA), the American Medical Association Guidelines on Gifts to
Physicians, and the Office of the Inspector General’s Guidance, released in
April 2003, as any of the foregoing may be amended or replaced from time to time
and any analogous codes and guidelines in countries and territories outside the
United States.

1.14 “Collaboration Security Agreement” has the meaning assigned to it in the
recitals.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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1.15 “Commercial Assay” means any Assay requested or ordered by any Third Party
to be performed by Monogram, but excluding Assays requested or ordered by Pfizer
or any other Person for purposes of conducting or supporting clinical
development work or human clinical trials.

1.16 “Commercially Reasonable Efforts” means, [*].

1.17 “Consolidator Performance Standards” has the meaning assigned to it in
Section 4.5(iii).

1.18 “Continuation Remedy” is defined in Section 12.4.

1.19 “Continuation Remedy Term” means the term that begins on the date when
Pfizer exercises the Continuation Remedy and ends on December 31, 2016.

1.20 “Costs of Services” means, for a given period, the cost as defined herein
for Assays performed in such period, which shall be equal [*].

1.21 “Costs of Services Cap” means, for 2007, [*], and for each succeeding year,
an amount equal to [*].

1.22 “Costs of Services Estimate” has the meaning assigned to it in
Section 3.5(b)

1.23 “Cost of Services True-Up Amount” has the meaning assigned to it in
Section 3.5(b)

1.24 “Costs of Services Reconciliation” has the meaning assigned to it in
Section 3.5(b)

1.25 “Coverage” means, as determined by Monogram using Commercially Reasonable
Efforts, the existence of funds available for payment to Monogram for a specific
Commercial Assay from private insurance, HMO plans, Medicare, Medicaid, state
insurance funds or other forms of medical care reimbursement, or self-insurance
or individual agreements to pay Monogram in advance.

1.26 “CPT” means the American Medical Association’s (“AMA”) “Current Procedural
Terminology” as published in the AMA’s CPT Process Manual, Fourth Edition and
any such future editions..

1.27 “Customer” means a physician, lab technician, nurse, social worker, patient
advocate, patient support personnel and other health-care provider.

1.28 “Diligent Efforts” means [*].

1.29 “DOJ” means the Department of Justice.

1.30 “Effective Date” has the meaning assigned to it in the preamble.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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1.31 “Encumbrance” means any security interest, pledge, mortgage, lien
(statutory or other), charge, option to purchase, lease or otherwise acquire any
interest or any claim, restriction, covenant, title defect, hypothecation,
assignment, deposit arrangement or any preference, priority or other security
agreement (including any conditional sale or other title retention agreement).

1.32 “Established Country” shall mean Argentina, Australia, Belgium, Canada,
France, Germany, Italy, Mexico, the Netherlands, Poland, South Africa, Spain,
Sweden, Switzerland, the United Kingdom and the USA, and each other country in
the Ex-US Territory that satisfies the Established Assay Criteria, effective as
of the first day of the calendar quarter following satisfaction of the
Established Assay Criteria, and once such country satisfies the Established
Assay Criteria, will remain an Established Country for the remainder of the
Term.

1.33 “Established Assay Criteria” shall mean, with respect to a country, (i) [*]
Qualifying Samples or Patient blood samples in connection with Pfizer clinical
trials originated from such country over a [*] period, either in connection with
a Pfizer clinical trial or a Commercial Assay, and (ii) during such [*], the
ratio of Qualifying Samples to the total number of Samples that originated from
such country is at [*]

1.34 “Qualifying Samples” shall mean Samples or Patient blood samples in
connection with a Pfizer clinical trial (i) that were actually received at the
Monogram Facility, and (ii) with respect to which Monogram performed Successful
Tests.

1.35 “Ex-US Country” has the meaning assigned to it in Section 3.1.

1.36 “Ex-US Territory” means worldwide other than the US Territory.

1.37 “FDA” means the United States Food and Drug Administration, or any
successor federal agency thereto.

1.38 “FTC” means the Federal Trade Commission.

1.39 “GAAP” means generally accepted accounting principles in the United States
of America as in effect from time to time.

1.40 “Governmental Approval” means any and all consents, approvals, licenses,
qualifications, designations, registrations or authorizations of any national,
supra-national (e.g., the European Commission or the Council of the European
Union), regional, state or other Governmental Authority.

1.41 “Governmental Authority” means any court, agency, department or other
instrumentality of any foreign, federal, state, county, city or other political
subdivision.

1.42 “IND” means an Investigational New Drug Application filed with the FDA or
the analogous application or filing filed with any analogous agency or
Government Authority outside of the United States (including any supra-national
agency such as in the European Union) necessary to commence human clinical
trials in such jurisdiction, and including all regulations at 21 CFR § 312 et
seq. and analogous regulations outside of the United States.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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1.43 “Indemnified Party” has the meaning assigned to it in Section 18.1.

1.44 “Indemnifying Party” has the meaning assigned to it in Section 18.1.

1.45 “Infrastructure Plan” has the meaning assigned to it in Section 5.2(a).

1.46 “ISC” has the meaning assigned to it in Section 5.2(a).

1.47 “JSC” has the meaning assigned to it in Section 4.1.

1.48 “Launch” means the first shipment of commercial quantities of the Pfizer
Product to a Third Party for commercial sale.

1.49 “Launch Date” means, with respect to a specific country, the first date
when commercial quantities of the Pfizer Product are shipped to a Third Party
for commercial sale.

1.50 “Laws” means any statutes or other laws, statutes, ordinances, rules,
regulations, orders, Codes, judgments or other enforceable requirements of any
Governmental Authority.

1.51 “Losses” has the meaning assigned to it in Section 18.1.

1.52 “Major Markets” means Brazil, France, Germany, Italy, Spain, and the United
Kingdom.

1.53 “Medicare Allowable Amount” means, prior to the establishment of the
National Limitation Amount, the amount of reimbursement paid by Northern
California CMS for the Assay.

1.54 “Monogram” has the meaning assigned to it in the preamble.

1.55 “Monogram Confidential Information” means all information about any
Monogram Technology, and any other information regarding the business and
operations of Monogram that is disclosed (whether orally or in writing) prior to
or after the Effective Date by Monogram to Pfizer or its Affiliates, to the
extent that such information is not (i) as of the date of disclosure to Pfizer,
known to Pfizer other than by virtue of a prior confidential disclosure to
Pfizer by Monogram; (ii) disclosed in published literature, or otherwise
generally known to the public through no fault or omission of Pfizer;
(iii) obtained from a Third Party free from any obligation of confidentiality to
Monogram; or (iv) independently developed by Pfizer without access or reference
to the Monogram Confidential Information as shown by competent written proof.

1.56 “Monogram Copyrights” means the registered copyrights identified on Annex B
and any other copyrights that are owned, licensed (but only to the extent that
further license rights may be granted by Monogram or a successor licensee in
respect of such licensed rights) or

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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otherwise controlled by Monogram and used in connection with the Assay following
the Effective Date. At the request of Pfizer, such request not to be made more
than once per calendar quarter, Monogram will provide an update of Annex B.

1.57 “Monogram Facility” means Monogram’s Assay testing facility currently
located at 345 Oyster Point Boulevard, South San Francisco, California and any
successor location as may be designated by Monogram in its sole discretion.

1.58 “Monogram Intellectual Property” means the Monogram Patent Rights, the
Monogram Technology, the Monogram Trademarks, and the Monogram Copyrights.

1.59 “Monogram Patent Rights” means the Patent Rights listed in Annex C and all
other Patent Rights owned, licensed (but only to the extent further license
rights may be granted by Monogram or a successor licensee in respect of such
licensed rights) or otherwise controlled by Monogram and that claim Monogram
Technology. At the request of Pfizer, such request not to be made more than once
per calendar quarter, Monogram will provide an update of Annex C.

1.60 “Monogram Technology” means any Technology necessary or useful in the
development, processing or commercialization of the Assay and that was or is
owned, licensed (but only to the extent that further license rights may be
granted by Monogram or a successor licensee in respect of such licensed rights)
or otherwise controlled by Monogram or any of its Affiliates, either alone or
jointly with a Third Party, prior to, as of or after the Effective Date.

1.61 “Monogram Trademarks” means the trademarks that are owned, licensed (but
only to the extent that further license rights may be granted by Monogram or a
successor licensee in respect of such licensed rights) or otherwise controlled
by Monogram and used in connection with the Assay following the Effective Date,
other than the name “Monogram”.

1.62 “National Limitation Amount” means the amount of reimbursement established
by CMS for the Assay pursuant to Section 1833(h)(4)(B) of the federal Social
Security Act.

1.63 “NDA” means a New Drug Application, filed with the FDA, as more fully
defined in 21 C.F.R. §314.50 et. seq.

1.64 “Note” has the meaning assigned to it in the recitals.

1.65 “Note Agreement” has the meaning assigned to it in the recitals.

1.66 “Parties” has the meaning assigned to it in the preamble.

1.67 “Patent Rights” means all claims contained in patent applications and
issued or granted patents, whether domestic or foreign, including continuations,
continuations-in-part, divisionals, provisionals and renewals, and letters of
patent granted with respect to any of the foregoing, patents of addition,
supplementary protection certificates, registration or confirmation patents and
all reissues, re-examination and extensions thereof and any patent restoration
or extension period granted by a Governmental Authority, including compensation
for patent term lost during the clinical trial or Regulatory Approval process.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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1.68 “Patient” means any person in respect of whom a Commercial Assay has been
requested or ordered.

1.69 “Performance Standards” means the standards for Assay testing set forth in
Annex A.

1.70 “Person” means an individual, corporation, partnership, company, joint
venture, unincorporated organization, limited liability company or partnership,
sole proprietorship, association, bank, trust company or trust, whether or not
legal entities, or any Governmental Authority.

1.71 “Pfizer” has the meaning assigned to it in the preamble.

1.72 “Pfizer Agent” means any agent, consultant or contractor of Pfizer that is
approved by Monogram, such approval not to be unreasonably withheld.

1.73 “Pfizer Confidential Information” means all information about any Pfizer
Technology, and any other information regarding the business and operations of
Pfizer, that is disclosed (whether orally or in writing) prior to or after the
Effective Date by Pfizer to Monogram or its Affiliates, to the extent that such
information is not (i) as of the date of disclosure to Monogram, known to
Monogram other than by virtue of a prior confidential disclosure to Monogram by
Pfizer; (ii) disclosed in published literature, or otherwise generally known to
the public through no fault or omission of Monogram; (iii) obtained from a Third
Party free from any obligation of confidentiality to Pfizer; or
(iv) independently developed by Monogram without access or reference to the
Pfizer Confidential Information as shown by competent written proof.

1.74 “Pfizer Facility” means a testing facility established for the sole purpose
of performing the Assay (i) that contains all physical assets required to
perform the Assay in substantially the same manner as it is performed at the
Monogram Facility as of the Effective Date, (ii) in which Pfizer is entitled to
utilize the license rights set forth in Section 13.1, (iii) possesses all
Regulatory Approvals to conduct such activity in such location and (iv) is
located at a site owned, leased or controlled by Pfizer within the continental
United States.

1.75 “Pfizer Facility Term” shall mean the term that begins on the date when
Pfizer starts to perform human clinical trial Assays in the Pfizer Facility (if
any) pursuant to the second sentence of Section 11.2(b) and ends upon the
termination or expiration of this Agreement.

1.76 “Pfizer Product” means maraviroc, also known as UK-427,857, and described
chemically
4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}
cyclohexanecarboxamide, as disclosed and specifically claimed in United States
Patent No. 6,667,314, and any salts, esters, prodrugs, metabolites, polymorphs
and derivatives thereof, including any finished formulations of the foregoing.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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1.77 “Pfizer Technology” means any Technology necessary or useful in the
discovery, development, manufacture or commercialization of the Pfizer Product
that is invented, discovered, owned, licensed, acquired or otherwise controlled
by Pfizer or any of its Affiliates, either alone or jointly with any Third Party
prior to or after the Effective Date.

1.78 “Privacy Regulations” means the Privacy Regulations 45 C.F.R. Parts 160 and
164.

1.79 “Reimbursement Approval” means, with respect to countries where
Governmental Authorities authorize reimbursement for, or approve or determine
pricing for Commercial Assays for reimbursement or other compensation, receipt
(or, if required to make such authorization, approval or determination
effective, publication) of such reimbursement authorization or pricing approval
or determination.

1.80 “Regulatory Approval” means any and all approvals, authorizations,
licenses, permits, accreditations and certifications of any national,
supra-national (e.g., the European Commission), regional, state or local
regulatory agency, department, bureau, commission, council or other Governmental
Authority that are necessary for a Party (or a Third Party acting on its behalf)
in connection with pharmaceutical products, diagnostic services or to undertake
an activity contemplated by this Agreement, including, in the case of the
performance of the Assay within the US Territory, all certifications under CLIA.

1.81 “Regulatory Authority” means any Governmental Authority with responsibility
for granting any Regulatory Approval, including the FDA in the United States and
any regulatory authority of countries of the European Union and Japan, and,
where applicable, any ethics committee or any equivalent review board.

1.82 “Regulatory Filing” means any filings required by Regulatory Authorities
relating to Regulatory Approvals.

1.83 “Representatives” means, with respect to a Party, such Party’s Affiliates,
licensees, officers, directors, employees, consultants, contractors,
sublicensees and agents.

1.84 “Sample” means a Patient blood sample (i) for which a Customer has provided
a complete test requisition form requesting a Commercial Assay (it being
understood that Monogram shall use Commercially Reasonable Efforts to obtain any
missing information) and (ii) that satisfies the Sample Handling Guidelines.

1.85 “Sample Handling Guidelines” means Monogram’s published guidelines as may
be in effect from time to time, the current version of which is attached hereto
as Annex D.

1.86 “Senior Executive” means, in the case of Pfizer, the worldwide commercial
head of Infectious Diseases, and in the case of Monogram, William D. Young,
Chairman and Chief Executive Officer, or any successor positions thereto which
include substantially the same responsibilities and authority.

1.87 “SOP” means standard operating procedures.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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1.88 “Successful Test” means an Assay test that has yielded a reportable result
within forty (40) days following Monogram’s receipt of the associated Sample in
the Monogram Facility.

1.89 “Tangible Material” means all tangible materials including vectors and cell
lines, protocols, SOP’s and analytical software that relate to the use of the
Monogram Patent Rights, the Monogram Technology or the Assay, each as may be
necessary to enable Pfizer to perform the Assay, including all improvements to
such tangible materials, which may from time to time be incorporated into the
Assay, as they are refined and improved.

1.90 “Technology” means all scientific and technical information, data, software
and designs, including know-how, trade secrets and technology related thereto,
but excluding any Patent Rights.

1.91 “Term” has the meaning set forth in Section 16.1.

1.92 “Third Party” means a Person other than (i) Pfizer, (ii) Monogram or
(iii) an Affiliate of either of them.

1.93 “Third Party Claim” has the meaning assigned to it in Section 18.2.

1.94 “US Territory” means the United States of America, including Puerto Rico.

1.95 Construction. Except where expressly stated otherwise in this Agreement,
the following rules of interpretation apply to this Agreement: (i) “include,”
“includes” and “including” are not limiting; (ii) definitions contained in this
Agreement are applicable to the singular as well as the plural forms of such
terms; (iii) references to an agreement or instrument mean such agreement or
instrument as from time to time amended, modified or supplemented;
(iv) references to a Person are also to its permitted successors and assigns;
(v) references to an “Article,” “Section,” “Exhibit” or “Schedule” refer to an
Article or Section of, or any Exhibit or Schedule to, this Agreement unless
otherwise indicated; (vi) the word “will” shall be construed to have the same
meaning and effect as the word “shall”; and (vii) the word “any” shall mean “any
and all” unless otherwise indicated by context. In the event an ambiguity or a
question of intent or interpretation arises, no presumption or burden of proof
shall arise favoring or disfavoring any Party by virtue of the authorship of any
provisions of this Agreement.

2. SUPPLY OF ASSAY IN THE US TERRITORY

2.1 US Territory Supply. Subject to the provisions of this Section 2, Monogram
agrees that it shall use Commercially Reasonable Efforts to make the Commercial
Assay available for sale to Customers in the US Territory in such amounts as may
be ordered. As between Pfizer (and its Affiliates) and Monogram, Monogram will
have the sole right and responsibility to sell and perform the Assay in the US
Territory, except as provided in Articles 11 and 12.

2.2 Reimbursement Responsibility. Monogram will use Commercially Reasonable
Efforts to obtain Coverage from payers in the US Territory for the Commercial
Assay at its own

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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risk and expense promptly following Regulatory Approval of the Pfizer Product in
the US Territory, which efforts shall include attempts to obtain applicable CPT
codes for the Commercial Assays. Pfizer shall have no obligation to seek to
obtain Coverage from payers in the US Territory or to compensate Monogram with
respect to Commercial Assays sold to Third Parties in the US Territory, but will
provide reasonable assistance if Monogram encounters difficulty in obtaining
reimbursements with respect to payers to the extent the JSC determines such
assistance is necessary, at Monogram’s expense. Reports regarding Monogram’s
reimbursement status and plans for the Commercial Assay in the US Territory will
be provided to the JSC on a quarterly basis.

2.3 Fulfillment Standards for the US Territory. Monogram will use Commercially
Reasonable Efforts to Arrange for Delivery of all Samples originating from
Customers in the US Territory. Monogram shall be required to perform the
Commercial Assay with respect to Samples originating from Customers in the US
Territory and received at the Monogram Facility in each calendar quarter based
upon their Coverage as provided below:

(a) All such Samples in respect of Patients who have Coverage in an amount [*]
of the Applicable Reimbursement Amount [*];

(b) in the case of such Samples in respect of Patients who are not [*], but have
Coverage in an amount [*] of the Applicable Reimbursement Amount (such Samples,
“[*],” and such Patients, “[*]”), a number of [*] in a given calendar quarter
that are no fewer than the lesser of (i) [*] of all Samples in such calendar
quarter and (ii) the total number of [*] in such calendar quarter; provided that
if in the calendar quarter that includes the first anniversary of Launch in the
US Territory, the percentage of [*] of all Samples in such calendar quarter, the
percentage of [*] that Monogram will be required to perform thereafter will be
increased for each subsequent calendar quarter to no fewer than [*] of all
Samples in a given calendar quarter and (y) the total number of [*] in such
calendar quarter; provided, further, that such percentage shall be reviewed at
the end of each successive calendar quarter, and will be reversed once the
percentage of [*] in a given calendar quarter falls below [*] of all Samples in
such calendar quarter; and

(c) [*].

For illustration purposes examples of the fulfillment standards for this
Section 2.3 are attached as Annex E.

2.4 Supply of Other Assays.

(a) Monogram’s Indigent Patient Program. To the extent Monogram in its sole
discretion offers and performs HIV tests for indigent patients, it shall also
offer and perform the Commercial Assay on a no less favorable basis on behalf of
indigent patients.

(b) Pfizer Marketing Programs. In addition to the Non-Covered Patients, Pfizer
shall have the right to require that Monogram perform the Commercial Assay to
support its Launch activities/marketing programs within the US Territory at a
per Assay cost to Pfizer equal to the Applicable Reimbursement Amount, up to a
maximum of [*] Commercial Assays per

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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calendar year. Pfizer will inform the JSC of the method by which Pfizer intends
to have the Commercial Assay distributed, whether by vouchers, coupons or other
means. Monogram will invoice Pfizer at the end of each calendar month for all
Successful Tests performed under such programs, and Pfizer shall pay Monogram
for such Commercial Assays in accordance with Article 6.

3. SUPPLY OF ASSAY IN THE EX-US TERRITORY

3.1 Ex-US Supply. In any country in the Ex-US Territory in which Pfizer intends
to Launch the Pfizer Product, Pfizer shall have the right to require Monogram to
make the Commercial Assay available for sale to Customers located in such
country pursuant to this Section 3.1 (any such country where Pfizer exercises
such right, an “Ex-US Country”); provided that Pfizer first shall have obtained
any Regulatory Approvals related to the sale of Commercial Assays in such
country. As between Pfizer and Monogram, Monogram will have the sole right and
responsibility to perform the Assay in the Ex-US Territory, except as provided
in Articles 11 and 12. Monogram shall use Commercially Reasonable Efforts to
Arrange for Delivery of all Samples originating from Customers in each Ex-US
Country (unless it has been relieved of its obligations to implement the
Infrastructure Plan for such Ex-US Country as provided in Article 5). Monogram
shall perform the Commercial Assay with respect to any Samples originating from
Customers in Ex-US Countries and received at the Monogram Facility.

3.2 Reimbursement Responsibility. Pfizer shall be fully responsible for
obtaining any reimbursement and pricing from payers, including Reimbursement
Approvals, at its own expense and risk, in any Ex-US Country. Monogram will
reasonably cooperate with Pfizer and consolidation partners in obtaining any
Reimbursement Approvals in such countries, at Pfizer’s expense. Monogram will be
fully subrogated to Pfizer with respect to the right to receive reimbursement or
other payment from Third Parties for Commercial Assays performed in respect of
Samples originating in the Ex-US Territory. In the event that a Third Party
makes a payment to Monogram in respect of a Commercial Assay performed in
respect of a Sample originating in the Ex-US Territory, Monogram shall promptly
remit such amount to Pfizer.

3.3 Regulatory Responsibility. With respect to any Ex-US Country for which
Regulatory Approvals related to the sale of Commercial Assays are applicable,
either (i) if mutually agreed by both Parties, Monogram shall use commercially
reasonable efforts to obtain any Regulatory Approvals related to the sale of
Commercial Assays in such country, at Pfizer’s expense, or (ii) otherwise Pfizer
(or a Pfizer Agent) shall use commercially reasonable efforts to obtain such
Regulatory Approvals itself at its own expense, but as Monogram’s agent or
Representative, in which case Monogram shall provide Pfizer with information
reasonably requested and cooperate with Pfizer in connection with the applicable
Regulatory Filings.

3.4 Sales and Marketing Responsibility. Pfizer shall, at its own expense and
risk, be fully responsible for sales and marketing of Commercial Assays in any
Ex-US Country, including but not limited to the provision of medical education,
marketing materials, test requisition forms, Sample Handling Guidelines,
advertisements, and training. Monogram will reasonably cooperate with Pfizer in
providing sample marketing and training materials in English, at Pfizer’s
expense.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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3.5 COMPENSATION.

(a) In consideration for making available for sale Commercial Assays to
Customers in the Ex-US Territory, for Commercial Assays performed with respect
to a Sample originating in an Ex-US Country, Pfizer shall pay to Monogram an
amount equal to [*], plus an amount equal to [*], plus, for each Successful
Test, [*] for such Commercial Assays, plus, in the case of any Commercial Assays
relating to Samples that originated from an Established Country in which the
Consolidator Performance Standards have been met for the previous calendar
quarter, an additional incentive payment equal to [*]. The amounts paid pursuant
to this Section 3.5 will be in addition to [*]. Monogram will invoice Pfizer at
the end of each month for all Commercial Assays performed with respect to
Samples originating in any Ex-US Country, providing details related to such
country. Pfizer shall pay Monogram for such Commercial Assays in accordance with
Article 6.

(b) The calculation of Costs of Services shall be determined based upon an
estimate prior to the commencement of each quarter and a reconciliation at the
end of such quarter (or upon any earlier termination of the Agreement or end of
the Term) as provided in this Section 3.5(b).

(i) No later than thirty (30) days prior to the beginning of each calendar
quarter during the Term, beginning with the first quarter of 2007, Monogram
shall deliver to Pfizer its reasonable and good faith estimate of the Costs of
Services for Commercial Assays for the following quarter of the Term, together
with reasonable supporting documentation relating thereto (a “Costs of Services
Estimate”). No later than the 45th day following the end of each calendar
quarter during the Term, beginning with the first quarter of 2007, Monogram
shall deliver to Pfizer a reconciliation of the Costs of Services Estimate for
the immediately preceding quarter to the actual Costs of Services incurred in
respect of such quarter together with reasonable supporting documentation
relating thereto (a “Costs of Services Reconciliation”).

(ii) The calculation of the Costs of Services Reconciliation by Monogram shall
be subject to review by Pfizer and, if Pfizer disagrees with such calculation
within fifteen (15) Business Days of submission by Monogram, the parties shall
resolve such dispute through the dispute reconciliation procedures set forth
herein. The amount by which the Costs of Services Estimate exceeds or is less
than the Costs of Services Reconciliation (as such amount is finally agreed by
the parties or resolved through dispute resolution) in respect of a given
quarter, expressed as a positive or negative number, is the “Costs of Services
True-Up Amount.”

(iii) If the Costs of Services True-Up Amount is determined pursuant to clause
(ii) to be a positive number, Monogram shall within thirty (30) days of such
determination repay to Pfizer, the amount by which all payments made pursuant to
Section 3.5(a) in respect of the preceding quarter were overstated. Similarly,
if the Costs of Services True-Up Amount is determined pursuant to the clause
(ii) to be a negative number, Pfizer shall within thirty (30) days of such
determination pay to Monogram the amount by which the Costs of Services for the
preceding quarter were understated.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(iv) Any Costs of Services Estimate provided in respect of the second quarter of
2007 or any quarter thereafter shall be assumed to be revised to be consistent
with the amount for Costs of Services reflected in the Costs of Services
Reconciliation for the preceding quarter, effective upon the issuance thereof,
absent demonstrable changes in circumstance. For the avoidance of doubt, nothing
in this Section 3.5(b) shall limit the Parties’ rights and obligations under
Section 15.1.

4. GOVERNANCE STRUCTURE OF THE ASSAY COLLABORATION.

4.1 Joint Steering Committee.

(a) A joint steering committee composed of three (3) employees from each of
Pfizer and Monogram (the “JSC”) shall oversee all aspects of Commercial Assay
supply, distribution, logistics, reimbursement and regulatory matters related to
this Agreement, including those matters specified in Section 4.5. Each of Pfizer
and Monogram shall designate one of its representatives as a co-chair of the
JSC.

(b) Initially, the JSC will consist of the following individuals:

 

Pfizer:      [*]      (Co-chair)      [*] Monogram:      [*] (Co-chair)      [*]
     [*]

(c) Each Party shall be entitled to change its representatives and/or designate
a new co-chair at any time on notice to the other Party. The co-chairs shall be
jointly responsible for setting the agenda for each meeting, and each co-chair
will be responsible for chairing alternating JSC meetings. From time to time,
the JSC may establish subcommittees or subordinate committees (that may or may
not include members of the JSC itself) to oversee particular projects or
activities, and such subcommittees or subordinate committees shall be
constituted and shall operate as the JSC agrees. At the end of the Term, the JSC
shall be automatically disbanded without action by either Party.

4.2 Decision-Making Authority.

(a) All decisions of the JSC made pursuant to this Agreement shall be made by
unanimous approval of the members of the JSC. In the event the JSC cannot
resolve any matter properly referred to it, either Party may refer the matter to
the Senior Executives for resolution. If after discussing the matter in good
faith and attempting to find a mutually satisfactory resolution to the issue,
the Senior Executives fail to come to an agreement on the matter within fifteen
(15) Business Days of the date on which the matter is referred to the Senior
Executives, the final decision-making authority shall be granted either to
Pfizer or Monogram in accordance with Section 4.2(b) or 4.2(c), as applicable,
and resolutions and final decisions reached through such provisions shall be
binding on the Parties, subject in all cases to Section 4.2(d).

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(b) Monogram will have final decision-making authority with respect to matters
related to supply, distribution, logistics, reimbursement, regulatory matters,
sales and marketing to the extent related to the Commercial Assays in the US
Territory. For clarification, Pfizer will have sole responsibility for the
development, registration, labeling or commercialization of the Pfizer Product.
Pfizer shall have no responsibility to supply, promote, distribute, seek
reimbursement for, or for regulatory matters related to, the Assay in the US
Territory.

(c) Pfizer will have final decision-making authority with respect to matters
related to distribution, logistics, reimbursement, regulatory matters, sales and
marketing related to Commercial Assays in each Ex-US Country.

(d) Decisions of the JSC or the Senior Executives must be made in good faith and
consistent with the provisions of this Agreement. For the avoidance of doubt,
nothing in this Article 4 shall deprive a Party of its rights as otherwise
provided under this Agreement. In addition, no decision made by a Party’s Senior
Executive under this Section 4.2 shall require the Party that does not have
final decision-making authority to incur expenses in addition to those
contemplated under this Agreement without reimbursement from the Party having
such final decision-making authority, or to engage in activities that are not
commercially reasonable or that such Party in good faith believes are not in
compliance with applicable Law.

4.3 Meetings. Following the Effective Date, the JSC shall hold meetings at such
times and places as the JSC co-chairs determine (it being expected that any
in-person meetings will alternate between the appropriate United States offices
of Pfizer and Monogram), but in no event shall such meetings be held less
frequently than once every calendar quarter. The JSC may:

(a) conduct such meetings in person, by videoconference or by telephone
conference;

(b) invite other personnel of the Party to attend meetings of the JSC as
appropriate to the agenda for such meeting, after giving advance notice to the
other Party;

(c) act without a meeting if, prior to such action, a consent thereto is signed
by the co-chairs of the JSC; and

(d) by unanimous consent, amend or expand upon the foregoing procedures for its
internal operation.

4.4 Minutes. At each meeting, the JSC shall elect a secretary who will prepare
minutes promptly after each meeting, reporting in reasonable detail the actions
taken by the JSC during such meeting, issues requiring resolution, and
resolutions of previously reported issues. Such minutes are to be reviewed and,
if reasonably complete and accurate, signed by the JSC co-chairs. The secretary
shall revise such minutes as necessary to obtain such signatures.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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4.5 JSC Functions and Powers. The JSC shall manage the activities of the Parties
as set forth in this Section 4.5, unless otherwise mutually agreed in writing by
the Parties. Notwithstanding anything to the contrary contained in this
Agreement, the JSC shall not have right to amend this Agreement or make any
decision or require either Party to take any action that conflicts with the
terms of this Agreement or that would impose, without reimbursement, additional
financial and other obligations on either Party, unless mutually agreed to by
the Parties. The JSC shall encourage and facilitate the collaborative
relationship and information exchange between the Parties in order to assist
each Party in fulfilling its obligations hereunder, and shall in particular:

(i) monitor the progress of the Parties carrying out their responsibilities
hereunder;

(ii) determine the physician education with respect to the Commercial Assay;

(iii) discuss and coordinate Pfizer’s planning and decision making process for
initiating the Additional Facility or the Pfizer Facility;

(iv) discuss and monitor access and reimbursement issues throughout the
Territory;

(v) address regulatory matters and issues and coordinate contacts with
Regulatory Authorities;

(vi) discuss the Monogram Trademarks; and

(vii) perform such other functions as appropriate to further the purposes of
this Agreement as mutually determined by the Parties.

With respect to the availability of Commercial Assays in countries in the Ex-US
Territory pursuant to Section 3.1, the JSC shall also:

(i) discuss, coordinate, approve and monitor plans regarding the availability of
Commercial Assays;

(ii) determine and approve the infrastructure required to support the
availability of Commercial Assays, including the associated budget;

(iii) determine whether to use couriers and/or consolidation laboratories in a
country, select such couriers and/or consolidation laboratories, approve
contracts with such couriers and/or consolidation laboratories and establish
Consolidator Performance Standards applicable to each Ex-US Country; and

(iv) approve all budgets, contracts and staffing requirements for the Ex-US
Infrastructure Costs and Ex-US Operating Costs.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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4.6 Independence. Subject to the terms of this Agreement, the activities and
resources of each Party shall be managed by such Party, acting independently and
in its individual capacity. The relationship between Monogram and Pfizer is that
of independent contractors and neither Party shall have the power to bind or
obligate the other Party in any manner, other than as is set forth in this
Agreement. Monogram and Pfizer are not joint ventures, partners, principal and
agent, employer and employee, and have no other relationship other than
independent contracting parties.

5. MONOGRAM’S EX-US INFRASTRUCTURE AND OPERATING COSTS.

5.1 Ex-US Country Infrastructure. In each Ex-US Country, Monogram shall, to the
extent approved by the JSC as described in Section 5.2 below, use Diligent
Efforts to establish and thereafter maintain an operational infrastructure of
personnel, relationships and resources, it being understood that Monogram’s or
its business partners’ personnel may be requested to cover several such
countries. The infrastructure established pursuant to this Section 5.1 will
service each Ex-US Country(ies) for purposes of assisting with the selection of
couriers and/or consolidation laboratory partners, and management of Sample
shipping to the Monogram Facility (including through the consolidation
laboratories, as appropriate), and support Pfizer’s reimbursement and regulatory
efforts subject to Section 3.3. All contracts (subject to the approval of JSC)
and employee relationships will be entered into by Monogram, and as between
Monogram and Pfizer, Monogram will be solely obligated thereunder.

5.2 Monogram Infrastructure Roles and Responsibilities.

(a) Infrastructure Plan.

(i) As provided in this Section 5.2, Monogram will use Diligent Efforts to
create an infrastructure plan outlining the functions described in Section 5.1
above to service each Ex-US Country (each such plan, an “Infrastructure Plan”).

(ii) The JSC will periodically meet to discuss Pfizer’s Launch plans for the
Ex-US Territory and to inform Monogram of the Ex-US Countries which Monogram
will be responsible for creating an Infrastructure Plan for those countries in
which Pfizer desires to Launch the Pfizer Product in the Ex-US Territory, and
where Pfizer elects to have the Commercial Assay available for sale. The first
such JSC meeting will occur within thirty (30) days following the Effective
Date, at which time the Parties will discuss the Launch plans and Pfizer will
present the JSC with its Launch plans and a general description of its needs for
services, whether it desires to consider consolidator laboratories and request
that the JSC assign responsibilities for creating an Infrastructure Plan to
Monogram for the countries set forth opposite the year 2006 in Annex I.
Thereafter, the JSC will meet at least semiannually to assign Monogram
responsibilities for creating additional Infrastructure Plans in additional
Ex-US Countries. In no event shall Monogram be required to create more
Infrastructure Plans per country/region in each calendar year than as set forth
in Annex I.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(iii) Monogram will have a budget for the purposes of creating Infrastructure
Plans equal to [*] in 2006, with which it may engage consultants and pay other
out-of pocket expenses beginning on the Effective Date. The budget for
subsequent calendar years will be established and approved by the JSC no later
than October 1 of the prior year.

(iv) At the first meeting of the JSC described above, the JSC shall form an
infrastructure sub-committee (“ISC”) consisting of representatives from both
Parties. The ISC will meet frequently (either in person or otherwise) to monitor
the activities of and consult with Monogram, and advise on the optimal scope of
services to be provided to service each Ex-US Country for which Monogram is
creating the Infrastructure Plan. Monogram will use Diligent Efforts to present
the Infrastructure Plan for each Ex-US Country to the JSC for review no later
than six (6) months after the JSC’s related request.

(v) The Infrastructure Plan will consist of an analysis of the feasibility,
benefits, issues, risks, optimal strategy for securing the services of Third
Parties and estimated budget for the following:

 

  A. Consolidation laboratory approach (to the extent requested)

 

  B. Courier approach

 

  C. Combination of (A) and (B) (to the extent requested)

(b) Infrastructure Plan Approval Process. The JSC may, following review, either
approve or reject elements of the Infrastructure Plans for each of the Ex-US
Countries. To the extent the JSC rejects any or all elements of any of
Monogram’s proposed Infrastructure Plans, Monogram shall have no obligation
under Section 3.1 with respect to Arranging for Delivery of Commercial Assays in
such Ex-US Country, under Section 5.5, or to implement such Infrastructure Plan
or to maintain an infrastructure with respect to such Ex-US Country.

5.3 Infrastructure Plan Implementation Process.

(a) To the extent the JSC approves the elements of an Infrastructure Plan,
Monogram shall use Diligent Efforts to implement the Infrastructure Plan to
service the related Ex-US Country within the budget presented by Monogram,
provided the JSC shall approve any final contracts. Monogram shall use Diligent
Efforts to make such Infrastructure Plan operational at the later of one
(1) month prior to the Anticipated Launch Date or six (6) months following
approval of such Infrastructure Plan by the JSC.

(b) Monogram will use Diligent Efforts to implement the Infrastructure Plan in
coordination with the ISC. For each Ex-US Country where Monogram has implemented
an infrastructure, Monogram shall present an annual budget for the
country-specific infrastructure and courier or consolidation lab contract
expenses/pricing to the JSC no later than on October 1 preceding the budget
year. If Monogram believes that providing the approved services will exceed the
budget for the applicable Ex-US Country by more than [*], Monogram shall
promptly

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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inform the JSC. If the actual expenses are more than [*] above the budgeted
amounts, Pfizer may assume for the following year the responsibility for the
applicable Ex-US Country’s infrastructure, provided that (i) such assumption
will not relieve Pfizer of (a) its obligations under Section 5.7 with respect to
the payment of Ex-US Infrastructure Costs and Ex-US Operating Costs incurred
prior to the time at which Pfizer assumes responsibility for such country or
(b) its remaining obligations under Section 5.7 with respect to the payment
of Ex-US Infrastructure Costs and Ex-US Operating Costs that are not specific to
such country, (ii) Pfizer will reimburse Monogram for any [*], and (iii)
Monogram will cooperate in transitioning its operations to Pfizer, and use
Diligent Efforts to assign any applicable Third-Party contracts to Pfizer, in
each case for such Ex-US Country.

5.4 Front End Transfers. In the event the JSC determines that a front-end
transfer of the Commercial Assay to a consolidation laboratory for performing
part of the Commercial Assay process is the only means of obtaining a required
Regulatory Approval in a specific Ex-US Country in the Ex-US Territory, Monogram
will incorporate in its Infrastructure Plans the elements of such front-end
transfer.

5.5 Logistic Responsibility in Ex-US Countries. With respect to Samples
originating in any Ex-US Country, to the extent Monogram has established the
infrastructure to service such relevant country, Monogram shall use commercially
reasonable efforts to implement and manage logistics (including distribution and
shipping from the site of Patient Sample blood draw, i.e., physician’s office or
local laboratory) to support the performance of the Commercial Assay with
respect to any such Sample received at the Monogram Facility. Without limiting
the foregoing, Monogram will use commercially reasonable efforts to provide
logistical support in such countries in English, manage the consolidation
partners, couriers and Sample distribution channels that route Samples from the
point of the blood draw site to such channels and then to the Monogram Facility.
In order to facilitate Monogram’s management of distribution and shipping of
Samples, Pfizer shall provide communication and feedback to health-care
providers regarding the shipping requirements. Monogram will have sole
responsibility for providing test results in local languages, as appropriate.

5.6 Employees; Contractors. Except as specifically provided herein, Monogram
shall have exclusive control over its employees and independent contractors.
Nothing in this Agreement shall be construed to conclude that any agents or
employees of Monogram are agents or employees of Pfizer or subject to Pfizer’s
direction and control. Monogram shall have sole authority over the terms and
conditions of its agents’ and employees’ employment, and shall select, engage,
and discharge its agents and employees at its discretion. Monogram will be
solely responsible for compensating its agents and employees whom it assigns to
perform services under this Agreement, including paying salaries and expenses,
providing benefits, deducting any applicable United States or foreign payroll
taxes, FICA, unemployment, workers compensation, medical or other insurance
contributions and making any other payments required by applicable Law to be
made on behalf of such employees.

5.7 Ex-US Infrastructure Costs and Operating Costs. Pfizer will reimburse
Monogram for [*] incurred by Monogram in connection with the performance of its
obligations under this Article 5. The [*] will include, among other things,
specifically [*] (“Ex-US Infrastructure Costs”), as well as [*] (“Ex-US
Operating Costs”).

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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5.8 Payments. Monogram will invoice Pfizer at the end of each month for all
expenses incurred in connection with the performance of its obligations under
this Article 5, and Pfizer shall reimburse Monogram for such expenses in
accordance with Article 6. The invoice will itemize each category of expenses
identified in this Article 5, as well as other expenditures related to
activities approved by the JSC or the ISC. The amounts under Section 5.7 above
in any quarter shall be reduced pro-rata on a country-by-country basis using the
volume and number of Commercial Assays performed in an Ex-US Country in
proportion to the total volume and number of assays performed by Monogram for
Samples originating in such country, if Monogram utilizes the infrastructure
developed in such country to conduct business other than the activities
contemplated by this Agreement.

6. INVOICING AND PAYMENTS

6.1 Invoicing. Monogram shall invoice Pfizer at the end of each month in respect
of the amounts to be paid to Monogram with respect to such month pursuant to
Sections 2.3(c), 2.4(b), 3.5, 5.8, 11.2 and 11.3. Pfizer shall make all payments
in respect thereof by wire transfer in accordance with the wire instructions set
forth in Section 6.2 below, within thirty (30) days after Pfizer’s receipt of
each invoice. Pfizer may request, and Monogram shall provide to Pfizer upon such
request, any reasonable additional supporting documentation relating to such
invoices.

6.2 Payment Method. All payments due under this Agreement from Pfizer to
Monogram shall be made at payor’s election, by electronic transfer in
immediately available funds via a bank wire transfer to such bank account(s) as
Monogram shall designate in writing at least five (5) Business Days before the
payment is due. All payments hereunder shall be made in US dollars. Conversion
of compensation under Section 3.3 or expenses as recorded in local currencies to
U.S. dollars for the purpose of calculating the payments made under this
Agreement will be performed in a manner consistent with Monogram’s normal
practices used to prepare its audited financial reports; provided that such
practices use a widely accepted source of published exchange rates.

6.3 Taxes.

(a) It is understood and agreed between the parties that any payments made to
Monogram under this Agreement shall be exclusive of any tariffs, duties or taxes
imposed or levied by any Governmental Authority, and all such tariffs, duties or
taxes, with the exception of income taxes payable by Monogram, are the sole
responsibility of Pfizer. If such tariffs, duties or taxes are paid or required
to be paid by Monogram, an equivalent amount shall be added to the amount
payable by Pfizer under this Agreement.

(b) Each Party agrees to cooperate and produce on a timely basis any tax forms
or reports, including an IRS Form W-8BEN, reasonably requested by the other
Parties in connection with any payment made by Pfizer to Monogram under this
Agreement. Each Party further agrees to provide reasonable cooperation to any of
the other Parties, at such other Party’s expense, in connection with any
official or unofficial tax audit or contest relating to payments made by Pfizer
to Monogram under this Agreement.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(c) In the event any of the payments made by Pfizer pursuant to this Agreement
become subject to withholding taxes under the Laws of any jurisdiction, Pfizer
shall increase its payment to Monogram such that Monogram receives the full
amount it would have received absent such withholding. Monogram will provide
Pfizer with reasonable assistance to enable Pfizer to recover such taxes as
permitted by Law. Monogram agrees to reasonably co-operate with Pfizer in any
valid tax exemption or reimbursement procedure permitted by any applicable
double taxation treaty and to co-operate in complying with any procedural
formalities (including the submission of applicable documentation) necessary
(i) to enable Pfizer to make payments owed hereunder without a tax withholding,
or with any reduced tax withholding which applies under the terms of the
applicable double taxation treaty, or (ii) for Pfizer to obtain a refund of any
taxes withheld.

6.4 Interest. All payments under this agreement shall bear interest from the
date due until the date paid at a rate equal to the thirty (30) day U.S. dollar
LIBOR rate effective for the date that payment was due, as reported by The Wall
Street Journal, plus 1%, computed on an actual/360 basis.

6.5 Advances. Notwithstanding anything herein to the contrary, in the event
Pfizer elects to exercise its right, pursuant to the last proviso of
Section 6(a) of the Note, to treat a portion of the outstanding amount of the
Note as an advance against amounts owed by Pfizer hereunder, Pfizer shall
thereafter be relieved of its obligations to make payments hereunder until the
full amount of such advance is exhausted.

7. PFIZER AND CUSTOMER EDUCATION.

7.1 Pfizer Education. Monogram shall educate Pfizer personnel, as appropriate,
on a periodic basis, on the specifications, benefits and limitations of the
Assay, as well as on shipping and handling of Samples.

7.2 Customer Education. Appropriately trained Pfizer representatives and
Monogram representatives, where deployed (it being understood that neither Party
shall have any obligation to deploy any such personnel), shall each educate the
Customers on the Commercial Assay and the procedures for processing thereof.
Pfizer sales representatives will be solely responsible for detailing the Pfizer
Product. Monogram shall make no claim that it has any right or interest in the
Pfizer Product, and will not promote the Pfizer Product unless expressly
permitted by Pfizer. Pfizer shall make no claim that it has any right or
interest in the Commercial Assay, except as provided in Section 11.2(b) and
Section 12.4, and Pfizer shall not, and shall not be required to, make any
statements with respect to the Commercial Assay, or, except as expressly set
forth in this Agreement, provide instruction or give advice on reimbursement for
the Commercial Assay, except as mutually agreed by the Parties and approved by
the JSC. Notwithstanding the foregoing, Pfizer may insert any content approved
by Monogram pertaining to the Commercial Assay into its own educational or
promotional materials, provided Pfizer shall not change such content. Pfizer may
request copies of any Monogram content pertaining to the Commercial Assay for
Launch in the US Territory, which Monogram shall provide within three (3) months
of such request.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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7.3 Materials; Call Center. Monogram will coordinate development of electronic
versions of training and educational materials relating to the Commercial Assay
for Pfizer personnel and Customers in English. Monogram will be responsible for
establishing a call center to handle inquiries related to the Commercial Assay.
For the Ex-US Territory, prior to Launch in an Ex-US Country, Pfizer will notify
Monogram if additional call center resources will be required for such country
or if inquiries for such country will be routed to Pfizer personnel. If
additional call center resources are required, Monogram will obtain such
resources to handle the calls from such country, at Pfizer’s expense pursuant to
Section 5.7.

8. REGULATORY AFFAIRS; COMPLIANCE WITH LAW.

8.1 Regulatory Filings and Approvals.

(a) In the US Territory, Monogram shall be responsible for preparing and
submitting all Regulatory Filings and seeking and maintaining all Regulatory
Approvals for the Commercial Assay, including preparing all reports necessary as
part of a Regulatory Filing or Regulatory Approval. Subject to the proviso to
Section 10.2, Pfizer shall provide all information and cooperation reasonably
requested by Monogram in connection with any Regulatory Filing or Regulatory
Approval or correspondence with any Regulatory Authority.

(b) In the Ex-US Territory, Pfizer shall be responsible for preparing and
submitting all Regulatory Filings and seeking and maintaining all Regulatory
Approvals for the Commercial Assay, including preparing all reports necessary as
part of a Regulatory Filing or Regulatory Approval. Subject to the proviso to
Section 10.2, Monogram shall provide all information and cooperation reasonably
requested by Pfizer in connection with any Regulatory Filing or Regulatory
Approval or correspondence with any Regulatory Authority.

8.2 Compliance with Law.

(a) Each of the Parties shall comply with all Laws applicable to its conduct
relating to this Agreement, including federal, foreign, and state fraud and
abuse and self-referral laws and all laws pertaining to access to and use,
maintenance, and transmission of HIV-related and other confidential patient
information, laboratory services billing, marketing and sales, and specimen
packaging and transport. Each Party represents and warrants that with respect to
all protected health information (as that term is defined in the Privacy
Regulations) if and to the extent such Party may have access to the protected
health information, it is either a covered entity (and not a business associate
of the other party) or otherwise permitted to have access to the protected
health information under the Privacy Regulations and that it shall protect the
privacy, integrity, security, confidentiality and availability of the protected
health information disclosed to, used by, or exchanged by the parties by
implementing and maintaining privacy and security policies, procedures, and
practices, and administrative, physical and technological safeguards and
security mechanisms that reasonably and adequately protect the confidentiality,
integrity and availability of the protected health information created,
received, maintained or transmitted under this

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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Agreement, all as required by, and set forth more specifically in, the Privacy
Regulations and the Security Regulations, as each may be amended from time to
time. In the event HIPAA or the Privacy Regulations or Security Regulations
require any addition to or modification of this Agreement, the parties shall use
commercially reasonable efforts to agree upon such additions or modifications in
a timely manner.

(b) The Parties agree that neither will take any action in the performance of
its obligations hereunder to improperly influence in any manner the results of
any Commercial Assay, it being of paramount importance to both Parties that
accurate test information be provided to all Customers and Patients for whom the
Commercial Assay is performed.

8.3 Licensure. The Monogram Facility is and shall remain duly licensed or
certified clinical laboratories under CLIA. Monogram shall use commercially
reasonable efforts to obtain any other Regulatory Approvals required with
respect to the Assay, or the Monogram Facility, including any which the FDA
determines are required. Pfizer will use commercially reasonable efforts to
assist Monogram in obtaining such Regulatory Approvals. Monogram shall provide
documentation of such license or certification upon Pfizer’s request. All
Commercial Assays performed by Monogram shall be in accordance with applicable
state and federal testing requirements for clinical reference laboratories.
Monogram shall maintain, and hereby certifies its and its employees are in
possession of, all existing necessary Regulatory Approvals to perform the
Commercial Assays in the US Territory and to undertake all other obligations of
Monogram hereunder and shall maintain all such Regulatory Approvals during the
Term.

8.4 Excluded Provider. Monogram represents and warrants that it is not an
Excluded Provider. For purposes of this Section 8.4, the term “Excluded
Provider” means a person or entity that either (i) has been convicted of a crime
related to health care, or (ii) is currently listed by a federal agency as
debarred, excluded or otherwise ineligible for participation in federally funded
programs (including federally-funded health care programs such as Medicare and
Medicaid). Monogram shall notify Pfizer within five (5) days after Monogram
receives notice that it is an Excluded Provider.

9. OWNERSHIP OF MATERIALS AND INTELLECTUAL PROPERTY

9.1 Except as specifically provided in this Agreement, no royalty or other
payment will be due to Monogram, its officers, employees, agents or permitted
sub-contractors from Pfizer with respect to Monogram’s performance of its
obligations under this Agreement.

9.2 For the avoidance of doubt, except as expressly provided in this Agreement,
neither Pfizer nor its Affiliates shall have any right, title or interest in or
to any Monogram Technology, Monogram Intellectual Property or Monogram
Confidential Information, including the testing methods, practices, or
procedures or in the test apparatus or equipment, or any improvements thereto,
developed by Monogram during the conduct of its business, whether used in the
performance of this Agreement or otherwise, and Pfizer hereby acknowledges that
it shall not acquire any right in respect thereof and that all such rights and
good will are and shall remain vested in Monogram, except as contemplated in
Articles 11 and 12, and the Collaboration Security Agreement.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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9.3 For the avoidance of doubt, nothing in this Agreement shall give Monogram
any right, title or interest in or to any of Pfizer’s compounds or methods of
compound synthesis, including the Pfizer Product, Pfizer Technology, Patent
Rights owned, licensed or controlled by Pfizer or Pfizer Confidential
Information.

9.4 For purposes of further clarification, nothing in this Agreement shall give
Pfizer or its Affiliates any rights in relation to any of Monogram’s nucleic
acid based vectors or its assay technology, except as contemplated in Articles
11 and 12, and the Collaboration Security Agreement.

10. CONFIDENTIALITY

10.1 Treatment of Confidential Information. The Parties agree that during the
Term, and for a period equal to the earlier of ten (10) years of the Effective
Date and five (5) years after the end of the Term, each Party will, and will
cause its Affiliates, (i) to maintain in confidence all Monogram Confidential
Information or Pfizer Confidential Information, as the case may be, to the same
extent such Party maintains its own proprietary information of similar kind and
value and (ii) not to use such Monogram Confidential Information or Pfizer
Confidential Information, as the case may be, for any purpose except those
expressly permitted by this Agreement. Pfizer and its Affiliates agree not to
disclose any Monogram Confidential Information to any Third Parties under any
circumstance without the prior consent of Monogram. Except as permitted by
Sections 10.2 or 10.3 below, Monogram and its Affiliates agree not to disclose
any Pfizer Confidential Information to any Third Parties under any circumstance
without the prior consent of Pfizer. If any Change of Control of Monogram
occurs, Monogram shall notify Pfizer promptly after execution of the agreement
providing for a transaction that, if consummated, would result in a Change of
Control, and, at Pfizer’s request, Monogram will, and will cause any Person that
becomes an Affiliate of Monogram upon consummation of such Change of Control to,
impose restrictions on access to the Pfizer Confidential Information including,
without limitation, establishing firewalls, as reasonably requested by Pfizer.

10.2 Authorized Disclosure. Pfizer and Monogram each agree that any disclosure
(i) by Pfizer or any of its Affiliates of Monogram Confidential Information, or
(ii) by Monogram or any of its Affiliates of Pfizer Confidential Information, in
each case to any of their respective officers, employees or agents shall be made
only if and to the extent reasonably necessary to carry out its rights and
obligations under this Agreement and shall be limited to the maximum extent
possible consistent with such rights and obligations. Monogram and Pfizer each
represent that all of their directors, officers, employees and agents who shall
have access to Pfizer Technology, Monogram Technology, Pfizer Confidential
Information or Monogram Confidential Information are bound by an agreement to
maintain such information in confidence. Notwithstanding the foregoing,
(x) Pfizer may disclose any Monogram Confidential Information to
(I) Governmental Authorities (a) to the extent reasonably necessary to obtain or
maintain INDs or Regulatory Approvals for the Pfizer Product, (b) to the extent
reasonably necessary to respond to inquiries, requests or investigations, and
(c) to the extent reasonably necessary to obtain Regulatory Approval and pricing
and reimbursement of the sale of the Commercial Assay in any Ex-US Country,
including any Reimbursement Approval, (II) Pfizer Agents or other business
consultants, attorneys, accountants or professional service providers, except
for

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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medical, scientific or technical consultants in the area of HIV or
antiretroviral resistance testing, and (III) to the extent necessary in order to
enforce Pfizer’s rights under this Agreement or the Note Agreement, (y) Monogram
may disclose any Pfizer Confidential Information (I) to Governmental Authorities
in order to respond to inquiries, requests or investigations, (II) to attorneys,
accountants or professional service providers (III) to outside consultants,
suppliers or subcontractors in connection with the Assay, (IV) to the extent
necessary in order to enforce Monogram’s rights under this Agreement; and
(z) Pfizer and Monogram may disclose any Monogram Confidential Information and
Pfizer Confidential Information, respectively, when required to be disclosed
under Law or in connection with a legal proceeding; provided that, in each case
enumerated in clauses (x), (y), and (z) of this Section 10.2, the disclosing
Party shall obtain the same confidentiality obligations from such Third Parties
as it obtains with respect to its own proprietary information of similar kind
and value.

10.3 Publicity. The press release announcing the signing of the transaction
contemplated by this Agreement is attached as Annex F hereto and will be
promptly disseminated following signing. Pfizer shall have the sole right to
make public announcements regarding the Pfizer Products in the Territory.
Monogram shall have the sole right to make public announcements regarding the
capabilities of the Assay, the availability of the Assay, the existence and
general terms of this Agreement and the Note Agreement, and progress of
Monogram’s business with regard to the Assay, which are consistent with the
press release attached hereto as Annex F. Without Pfizer’s consent, Monogram
shall not be permitted to make any public announcement concerning the
reliability of the Commercial Assay that implies that Pfizer endorses or makes
representations to the public concerning the accuracy and reliability of the
Assay, except for announcements that acknowledge the relative contractual
responsibilities of the Parties under this Agreement. Other than such
announcements, neither party, without the prior approval of the other party,
shall originate any publicity, news release or public announcement, written or
oral, whether to the public press, stockholders or otherwise, relating to this
Agreement, the subject matter to which it relates, performance under it or any
of its terms, to any amendment hereto or performance hereunder (herein referred
to as an “Announcement”), except for such an Announcement which (x) is required
by Law, applicable stock exchange regulation or legal (including but not limited
to judicial, arbitral and administrative) proceedings to be made or (y) is
contained in a Party’s filings with the Unites States Securities and Exchange
Commission. Other than public announcements described in the second and third
sentences of this Section 10.3 and Announcements described in clauses (x) and
(y) of this Section 10.3, a Party will give the other Party at least ten
(10) days’ advance notice of the text of any proposed Announcement so that the
other party will have an opportunity to comment upon the Announcement. For an
Announcement required by clause (x) of this Section 10.3, each party will
endeavor to give the other Party reasonable notice, which presumptively shall be
ten (10) days notice, unless circumstances require that the Announcement be
released sooner.

10.4 Data Ownership; Publications. Pfizer shall be the sole owner of any data or
other information related to the Pfizer Product, Pfizer Product data or tropism
data generated in a Pfizer clinical trial or otherwise controlled by Pfizer, and
neither Monogram nor its Affiliates will have any right to publish or present
any information related to the Pfizer Product, Pfizer Product data or Pfizer
tropism data without the consent of Pfizer. Monogram shall be the sole

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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owner of any data or other information related to tropism data generated by
Monogram independently of Pfizer’s human clinical trials or otherwise controlled
by Monogram, and neither Pfizer nor its Affiliates will have any right to
publish or present any information related to such tropism data without the
consent of Monogram.

10.5 Agreement Filing. To the extent, if any, that a Party concludes that it is
required under applicable Laws to file or register this Agreement or a
notification thereof with any Governmental Authority, including the United
States Securities and Exchange Commission, the FTC or the DOJ, such Party may do
so; provided that such Party shall provide the other Party with a written copy
of all proposed filings, registrations or notifications within such time frame
as to allow for a reasonably sufficient time for review and comment by the other
Party prior to the submission of such proposed filing, registration or
notification. The other Party shall cooperate with such filing, registration or
notification and shall execute all documents reasonably required in connection
therewith. To the extent permitted by applicable Law, the Parties will request
confidential treatment of sensitive provisions of this Agreement. The Parties
shall promptly inform each other as to the activities or inquiries of any such
Governmental Authority relating to this Agreement and shall cooperate to respond
to any request for further information therefrom.

11. ADDITIONAL OR PFIZER TESTING FACILITY

11.1 Establishment of Additional Testing Facility. The Parties acknowledge that
Pfizer may desire during the Term to establish an Additional Facility or a
Pfizer Facility (but not both) which, in either case, as between Pfizer and
Monogram, shall be owned or leased by Pfizer. Pfizer shall have the right,
exercisable in its sole discretion at any time by notice to Monogram, to require
Monogram to undertake any or all of the activities specified below associated
with the establishment of an Additional Facility or Pfizer Facility, it being
acknowledged that (i) the Parties will use Diligent Efforts to ensure that any
Additional Facility shall be operational, including obtaining any applicable
Regulatory Approvals within fifteen (15) months of the date of such notice and
(ii) Monogram shall not be authorized to and shall not enter into any
contractual obligation with respect to the Additional Facility or Pfizer
Facility to be developed pursuant to this Article 11 without the advance
approval of Pfizer. At the request of Pfizer, Monogram shall use Diligent
Efforts to:

(a) Identify modifications and improvements in the physical location selected
for the Additional Facility or the Pfizer Facility that are required to perform
the Commercial Assay;

(b) Identify all equipment and third party services (including insurance
coverage and courier and other logistical support services) required to perform
the Commercial Assay at the Additional Facility or the Pfizer Facility;

(c) With respect to an Additional Facility, negotiate with vendors of the
equipment and services identified in the preceding clause;

(d) Establish protocols for the performance of the Commercial Assay at such
Additional Facility;

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(e) Identify Regulatory Approvals needed to perform the Assay in the Additional
Facility or the Pfizer Facility, and use Commercially Reasonable Efforts to
obtain Regulatory Approval of the Additional Facility under CLIA;

(f) In the case of the Additional Facility, identify and retain the personnel
who shall be employed at such facility;

(g) Create, develop and implement a comprehensive training program for personnel
who will be employed at either the Additional Facility or the Pfizer Facility;
and

(h) Provide such other services as may be reasonably necessary to commence
operations at such Additional Facility and are reasonably requested by Pfizer to
be provided.

11.2 Operation of Additional Testing Facility.

(a) In the case of the Additional Facility, Monogram shall operate the
Additional Facility and performing the Assay and shall employ and be responsible
for all salary, benefits and other obligations to the persons required to carry
out these functions, shall maintain insurance coverage in respect of such
operations and comply with all applicable Laws. Monogram shall retain any and
all payments received from Customers or otherwise in respect of Assays performed
at the Additional Facility. Monogram shall operate the Additional Facility in
consultation with the JSC and in accordance with all requirements hereunder that
would apply to its operation of the Monogram Facility and the performance of the
Commercial Assay in the Monogram Facility. Upon not less than two weeks notice
to Monogram, Pfizer or any Pfizer Agent shall have the right to appoint a
reasonable number of personnel to observe the activities at the Additional
Facility no more frequently that once per calendar quarter, and pursuant to the
provisions of Section 14.1, Monogram shall train any such persons in all aspects
of the Assay and its performance. Notwithstanding anything herein to the
contrary, in the event Pfizer exercises its Continuation Remedy, Pfizer shall
have the right to assume control of the operations of the Additional Facility.

(b) In the case of a Pfizer Facility, Pfizer or Pfizer Agent shall operate such
facility and shall employ all individuals who are operating such facility and
performing the Assay at such location, it being agreed that such personnel shall
be trained by Monogram as part of the establishment of such facility as
specified in Section 11.1. For so long as Pfizer has not exercised its
Continuation Remedy, Pfizer agrees that the only activity or business it shall
perform at such facility shall be the performance of no more than [*] of the
Assays necessary to support Pfizer’s human clinical trials, and it shall pay
Monogram a royalty of [*] for each such Assay it performs. Following the
exercise of Pfizer’s Continuation Remedy, the royalty for Pfizer’s human
clinical trial requirements shall be governed by Section 12.4(c).

11.3 Reimbursement. Pfizer shall reimburse Monogram for [*] incurred in
providing the assistance contemplated by Section 11.1 and the services specified
in Section 11.2(a), provided that such reimbursement for services specified in
Section 11.2(a) shall not be required in any calendar year in which Monogram
performs more than [*] Commercial Assays.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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11.4 Abandonment. Notwithstanding anything in this Article 11 to the contrary,
Pfizer shall have the right in its sole discretion to abandon the establishment
of an Additional Facility or the Pfizer Facility; provided, however, that
(i) such abandonment shall not relieve Pfizer of its obligations under
Section 11.3, and (ii) after commencement of Monogram services pursuant to
Section 11.2(a), Pfizer shall first provide Monogram with not less than six
(6) months advance notice.

11.5 Monogram Option. At the end of the Term or upon any abandonment of an
Additional Facility during the Term, Monogram shall have an option to acquire
any of the equipment and other assets owned by Pfizer that are part of the
Additional Facility or the Pfizer Facility for an amount equal to the
depreciated book value of such equipment and other assets (as evidenced by
reasonable supporting documentation provided by Pfizer), and (ii) assume all
obligations under any real property lease or other contract related solely to
the Additional Facility; provided, however, if this agreement terminates
pursuant to Sections 16.2 and 16.5, Monogram shall forfeit such option, and if
Pfizer terminates this Agreement during the continuance of a material breach
(other than a material breach resulting in a termination under Section 16.2),
Monogram’s right to purchase such equipment and other assets shall be at the
actual cost incurred by Pfizer and not the depreciated book value.

11.6 Alternative Arrangements. The Parties recognize that it may be mutually
beneficial and may wish in good faith to propose, discuss and review potential
alternative arrangements with a view of providing Pfizer with other methods by
which it can obtain operational and other benefits similar to those provided
under Sections 11.1 through 11.5 above. For clarification, the Parties agree
that the failure to engage in discussions or to reach mutual agreement on the
subject matter of this Section 11.6 shall not constitute a breach of this
Agreement by either Party, nor shall it affect the rights and obligations of the
Parties under Sections 11.1 to 11.5 above.

12. PERFORMANCE STANDARDS; CERTAIN BREACH REMEDIES

12.1 Forecasting.

(a) Beginning one year prior to the first Anticipated Launch Date of the Pfizer
Product, and each at the beginning of each [*] thereafter, Pfizer shall provide
Monogram with a non-binding forecast of the [*] demand for the Commercial Assay
within the Territory for the following [*] (which forecasts will include
activity/marketing demand and any “special programs” to be conducted by Pfizer)
so that Monogram may make plans to meet the demand for the Commercial Assay (the
“Rolling Forecast”).

(b) Pfizer’s Rolling Forecast for the Commercial Assay shall be considered
“Locked” for the [*] for which a Rolling Forecast is provided. For purposes of
illustration, the dates of the “Locked” Rolling Forecast are provided below:

 

Date on or before which Rolling Forecast is provided

 

Pfizer’s Forecast is “Locked” for the aggregate of the three months

[*]   [*] [*]   [*] [*]   [*] [*]   [*]

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(c) In the event that in any [*] the actual demand for the Assay [*], Monogram
shall not be required to meet the Performance Standards for such [*], and
Monogram shall not be held in material breach for non-compliance with such
standards, provided, however, it shall use Diligent Efforts to complete the
Assays as quickly as practicable under the circumstances.

(d) All Rolling Forecasts will be non-binding and shall not imply any obligation
on the part of Pfizer to purchase itself or warrant the purchase of Assays by
itself or any Third Party.

12.2 Performance Standards. Monogram shall perform its obligations in respect of
Commercial Assays with respect to Samples originating in the Established
Countries in accordance with the Performance Standards (other than the
Consolidator Performance Standards), measured collectively on a quarterly basis.

12.3 Pfizer Access in event of Material Breach. In the event of any material
breach of Sections 2.1, 2.2, 2.3, 3.1 and 12.2 of this Agreement, upon notice by
Pfizer and subject to compliance with reasonable restrictions established by
Monogram, Monogram shall permit Pfizer reasonable access to the Monogram
Facility and its executives in order to observe or discuss the activities at the
Monogram Facility and to ascertain the cause of such material breach and a
possible solution.

12.4 Pfizer Remedy for Breach.

(a) (i) Upon any material breach of Sections 2.1, 2.2, 2.3, 3.1 or 12.2 that is
not cured within ninety (90) days of a notice of such breach from Pfizer, or
(ii) immediately upon the repudiation or rejection of Monogram’s obligations
hereunder, Pfizer shall have the right, exercisable upon notice to Monogram, at
any time (a) such material breach is continuing or (b) Monogram has not
thereafter acknowledged its obligations hereunder, respectively, but no later
than one year following the relevant cure period, to commence performance of
Assays for its own human clinical trials and for the performance of the
Commercial Assay, either itself and/or through a Third Party contractor,
licensee, or sublicensee, including without limitation at the Additional
Facility or the Pfizer Facility (“Continuation Remedy”). Pfizer’s right to
exercise its Continuation Remedy shall be in addition to any right of
termination under Article 16 and any other remedies it may have at law or in
equity. The Parties agree that a material breach of Sections 2.1, 2.3, 3.1 or
12.2 will not arise to the extent failure to perform is caused by
(a) consolidation laboratory performance, (b) any failure to complete a
front-end transfer of the Assay, so long as Monogram utilizes Commercially
Reasonable Efforts to effect such transfer, and/or (c) an FDA exercise of
jurisdiction over the Monogram Facility and/or the Assay, so long as Monogram
utilizes Commercially Reasonable Efforts to comply with such FDA requirements.

(b) For the purposes of exercising the Continuation Remedy at the Additional
Facility or the Pfizer Facility, and performing the Assay for clinical trials at
the Pfizer Facility pursuant to Section 11.2(b), Monogram is hereby granting to
Pfizer the following present rights and interests, (i) the non-exclusive license
described in Article 13, (ii) a security interest as set forth

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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in the Collaboration Security Agreement, and (iii) the right to use the Tangible
Materials as described in Section 14.2. In addition, for such purposes, Monogram
is hereby granting to Pfizer the right for Pfizer personnel to be trained at the
Monogram’s facility as described in Article 14.

(c) If following exercise of the Continuation Remedy, Pfizer performs the Assay,
either directly (whether at the Additional Facility, the Pfizer Facility or
otherwise) or through the use of a Third Party, Pfizer shall pay Monogram a
royalty of [*].

(d) Monogram shall use Commercially Reasonable Efforts to ensure that any
license it obtains from a Third Party after the Effective Date with respect to
Monogram Intellectual Property expressly permits Monogram to sublicense such
license to a Third Party, and expressly permits sublicensees to assume
Monogram’s license rights upon an event that would otherwise result in
termination of the license, or loss of such license rights. For clarification,
in no event shall Monogram be obligated to obtain such sublicensing rights if it
would be required to pay additional consideration therefor (whether in the form
of upfront payments or increased royalty rates). Monogram hereby acknowledges
that in entering into its licensing arrangements with Third Parties, it shall
not obligate itself to pay higher royalties or other amounts for Third-Party
intellectual property used in the Ex-US Territory relative to such intellectual
property used in the US Territory.

(e) Monogram agrees that it will use Commercially Reasonable Efforts to obtain
licenses to all Third Party intellectual property which Monogram deems in its
reasonable judgment to be necessary to make, use/perform, sell, and import the
Commercial Assay. Monogram agrees that it will provide Pfizer with complete
copies of any such licenses it obtains.

13. INTELLECTUAL-PROPERTY LICENSE.

13.1 License to Pfizer. (a) Subject to the terms of this Agreement and
Section 13.1(b) below, Monogram hereby grants to Pfizer:

(i) a non-exclusive, worldwide, license, with the right to sublicense (to the
extent permitted), to use the Monogram Technology, the Monogram Copyrights, and
the Monogram Confidential Information to make, have made, use/perform, sell or
import the Assay (as it may exist as of the time these licensed rights are first
exercised) in the Territory;

(ii) a non-exclusive, worldwide, license, with the right to sublicense (to the
extent permitted), under the Monogram Patent Rights to make, have made,
use/perform, sell or import the Assay (as it may exist as of the time these
licensed rights are first exercised) in the Territory; and

(iii) a non-exclusive, worldwide, license, with the right to sublicense (to the
extent permitted), to use the Monogram Trademarks on or in connection with the
Assay (as it may exist as of the time these licensed rights are first exercised)
in the Territory.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(b) Notwithstanding anything in the contrary herein, Pfizer shall exercise or
otherwise exploit the licensed rights that are being granted on the Effective
Date only (i) to exercise its rights as permitted under and pursuant to
Section 11.2(b) and in that event only during the Pfizer Facility Term and
(ii) to exercise its rights as permitted under and pursuant to Sections 12.4(a)
and 12.4(c) and in that event only during the Continuation Remedy Term.

(c) All rights and licenses granted under or pursuant to this Agreement by
Monogram are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Article 101 of the U.S. Bankruptcy Code. The parties
agree that Pfizer, as licensee of such rights under this Agreement, shall retain
and may fully exercise all of its rights and elections under the U.S. Bankruptcy
Code, or equivalent legislation in any other jurisdiction. The parties further
agree that, in the event of the commencement of a bankruptcy proceeding by or
against Monogram under the U.S. Bankruptcy Code, Pfizer shall be entitled to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property and any Tangible Material, if not already in their
possession, shall be promptly delivered to it (a) upon any such commencement of
a bankruptcy proceeding upon its request therefor, unless Monogram elects to
continue to perform all of its obligations under this Agreement or (b) if not
delivered under (a) above, upon the rejection of this Agreement by or on behalf
of Monogram upon request therefor by Pfizer.

14. TRAINING OF PFIZER PERSONNEL IN THE ASSAY; MATERIALS AND DOCUMENTATION
TRANSFER.

14.1 Commencing thirty (30) days after the filing of an NDA with respect to
Pfizer Product, Pfizer shall have the right to have two (2) employees trained at
the Monogram Facility in all aspects of performing the Assay at least annually,
it being understood that Pfizer may request that Monogram train different
employees every year; provided, if there are modifications to the Assay
performance, Monogram shall train Pfizer’s employees at the Monogram Facility
upon Pfizer’s reasonable request at the Monogram Facility; provided, further
that during any time following satisfaction of one or more of the conditions set
forth in Section 12.4(a)(i), (ii) or (iii), Pfizer shall be able to have such
personnel trained and present at the Monogram Facility on demand.

14.2 Monogram agrees to transfer the Tangible Material to Pfizer within 30 days
of execution of this Agreement, to be held by Pfizer for use solely for the
purposes of exercising its rights under Sections 11.2(b), and upon exercise of
the Continuation Remedy. Monogram also agrees to provide detailed storage
instructions to enable the safe keeping of Tangible Material. Monogram agrees to
transfer to Pfizer all improvements to the Tangible Material which may from time
to time be incorporated in to the Assays, as soon as reasonably practical
following development by Monogram.

14.3 In order for Pfizer to exercise its Continuation Remedy, Pfizer shall be
free to make and reproduce such Tangible Materials following the exercise of its
Continuation Remedy to the extent necessary to perform Assays as permitted
pursuant to Section 12.4 above and ensure the continued integrity/function of
such Tangible Material. Monogram shall train a reasonable number of Pfizer
personnel with respect to the Tangible Materials for clinical use, including
reproducing the Tangible Material to perform the Commercial Assay.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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14.4 Pfizer agrees that it will comply with all applicable governmental
regulatory and statutory requirements regarding use of the Tangible Materials.
For the avoidance of doubt, Pfizer will make no use of the Tangible Material
except as provided in Sections, 11.2(b) or 14.2 and until Pfizer has exercised
its Continuation Remedy.

15. RECORDS; OTHER ASSAY LIMITATION.

15.1 Records; Audits.

(a) Monogram shall, and shall cause its Affiliates and sublicensees to, provide
to Pfizer the reports identified in Annex G, and keep accurate books and records
related thereto. Monogram shall permit Pfizer, by independent qualified public
accountants employed by Pfizer and reasonably acceptable to Monogram, to examine
such books and records at any reasonable time following the rendering of any
corresponding reports, accountings and payments provided by Monogram hereunder.
Such accountants may be required by Monogram to enter into a reasonably
acceptable confidentiality agreement, and in no event shall such accountants
disclose to Pfizer any information other than such as relates to the accuracy of
reports and payments made or due hereunder. The opinion of such accountants
regarding such reports, accountings and payments shall be binding on the
Parties, other than in the case of manifest error. Pfizer shall bear the cost of
any such examination; provided that if such examination shows an overpayment by
Pfizer of more than [*]% for the applicable period (for purposes of such
calculation, differences, if any, between Costs of Services Estimates and Costs
of Services Reconciliations delivered in accordance with Section 3.5(b) shall be
disregarded), then Monogram shall promptly reimburse Pfizer for all costs
incurred in connection with such examination. Monogram shall promptly re-pay to
Pfizer any amounts of any overpayments of amounts revealed by an examination
(including interest payable in accordance with Section 6.4), and Pfizer shall
promptly pay to Monogram any amounts of any underpayments of amounts revealed by
an examination (without any interest).

(b) Upon Pfizer’s reasonable request, Pfizer shall have the right to conduct an
quality-assurance audit in accordance with Pfizer’s quality-assurance policies
then in effect. Pfizer shall be permitted to conduct such audit no more
frequently than once every [*].

15.2 Other Assay Limitation. During the Term, Monogram agrees that it shall not
enter into any agreement or other arrangement with Third Parties providing that
other HIV assays will be given priority ahead of the Commercial Assay.

16. TERM; TERMINATION.

16.1 Term. This Agreement shall become effective on the Effective Date and,
unless earlier terminated as provided herein, shall continue until December 31,
2009, provided that Pfizer shall have the right to extend this Agreement on up
to five (5) successive occasions for additional terms of one-year each, such
right to be exercised by providing notice to Monogram no later than six
(6) months prior to the then applicable termination date (“Term”).

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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16.2 Termination Upon Exercise of Continuation Remedy by Pfizer. This Agreement
shall automatically terminate upon the exercise by Pfizer of the Continuation
Remedy.

16.3 Termination at Will. (a) After the Effective Date, Pfizer may terminate
this Agreement in whole or in part with respect to any country, at any time in
its sole discretion, upon ninety (90) days’ advance notice to Monogram, with
such termination becoming effective at the end of such ninety (90)-day period.

(b) Monogram may terminate this Agreement in whole in the event Pfizer
terminates this Agreement with respect to all Ex-US countries pursuant to clause
(a) of this Section.

16.4 Monogram Termination Right. If Monogram believes that Pfizer is in material
breach of this Agreement, Monogram may deliver notice of such material breach to
Pfizer, such notice to describe in detail the nature of such breach. For
purposes of this Section 16.4, a material breach shall include a material
inaccuracy in any representation or warranty contained herein. Pfizer shall have
sixty (60) days from its receipt of such notice to cure such material breach.
Any such termination shall become effective at the end of such sixty (60)-day
period unless Pfizer has cured any such breach prior to the expiration of such
sixty (60)-day period.

16.5 Other Termination Rights. If a Party is generally unable to meet its debts
when due, or makes a general assignment for the benefit of its creditors, or
there shall have been appointed a receiver, trustee or other custodian for such
Party for all or substantially all of its assets, or any case or proceeding
shall have been commenced or other action taken by or against such Party in
bankruptcy or seeking the reorganization, liquidation, dissolution or winding-up
of such Party or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law, and any such event shall have
continued for sixty (60) days undismissed, unstayed, unbonded and undischarged,
the other Party may, upon notice to the first Party, terminate this Agreement,
such termination to be effective upon the first Party’s receipt of such notice.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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16.6 Effect of Termination.

(a) Survival. All covenants and agreements herein, including licenses and
sublicenses granted hereunder shall terminate upon termination of this
Agreement; provided (A) that the following provisions shall survive any
expiration or termination of this Agreement: Articles 1 (Definitions), 10
(Confidentiality), 18 (Indemnities), 19 (Miscellaneous), 9 (Ownership of
Materials and Intellectual Property), and this Section 16.6 (Effect of
Termination), together with any sections or defined terms referred to in such
provisions, surviving provisions necessary to give them effect, and (B) upon
Pfizer’s exercise of the Continuation Remedy, the following provisions shall
survive in addition to the Articles and Section identified in the preceding
subclause (A): Article 13 (Intellectual-Property Matters), and Sections 12.4(a),
12.4(b), 12.4(c), 14.2, 14.3 and 14.4, together with any sections or defined
terms referred to in such provisions, surviving provisions necessary to give
them effect.

(b) In the event Pfizer elects not to renew this Agreement pursuant to
Section 16.1 or this Agreement is terminated pursuant to Sections 16.3(a), 16.4
or 16.5, Monogram shall advise Pfizer within ninety (90)-days of such notice or
election or termination whether it intends to dismantle the Infrastructure with
respect to any Ex-US Country. In the event Monogram elects to dismantle such
Infrastructure, provided Monogram takes commercially reasonable steps to
minimize further expenses, and Monogram actually terminates and winds-down
contracts and terminates the employment of persons related thereto, Pfizer will
reimburse Monogram for its out-of-pocket expenses incurred in connection with
such termination and wind-down, provided (i) Pfizer shall not be obligated to
reimburse Monogram for any expenses associated with Monogram’s termination and
wind-down that, if Pfizer terminates this Agreement due to Monogram’s material
breach or exercise of the Continuation Remedy and (ii) to the extent permissible
by their terms, all agreements with couriers and consolidation laboratories will
be assigned to Pfizer, if Pfizer exercises the Continuation Remedy.

(c) Any termination or expiration of this Agreement shall not relieve the
Parties of any liability that accrued (including any liability that accrued as
of result of a breach) hereunder prior to such termination or expiration. In
addition, any termination or expiration of this Agreement shall not preclude any
Party from pursuing all rights and remedies it may have hereunder or under the
governing law as defined in Section 19.7 below (including specific performance
and injunctive relief). The remedies provided herein are not exclusive of other
remedies available to a Party under the governing Law as defined in Section 19.7
below.

17. REPRESENTATIONS AND WARRANTIES

17.1 Corporate Representations and Warranties. Each Party represents and
warrants to the other Party that, as of the Effective Date:

(a) such Party is a company duly organized, validly existing and, to the extent
such concept is known in the respective jurisdiction, in good standing under the
Laws of its state of incorporation, and such Party has the full corporate power
and authority to own and operate its properties and assets and to conduct its
business as presently conducted by it. Such Party has all necessary corporate
power and authority to enter into this Agreement and perform its obligations
hereunder and to carry out the transactions contemplated hereby;

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(b) such Party is duly qualified to do business in its state of incorporation
and is, to the extent such concept is known in the respective jurisdiction, in
good standing in each jurisdiction in which the character or location of its
properties and assets owned or operated by it or the nature of the business
conducted by it makes such qualification necessary;

(c) all corporate action has been taken on the part of such Party’s directors
and shareholders necessary for the authorization, execution, delivery of, and
the performance of all obligations of such Party under this Agreement. This
Agreement, when executed and delivered by such Party, and assuming the due
execution by the other Parties, will constitute valid and legally binding
obligations of such Party enforceable against such entity in accordance with its
terms;

(d) no Governmental Approval, or consent, approval or waiver of any other
Person, is required to be made or obtained by such Party in connection with the
execution and delivery of, and performance of its respective obligations under
this Agreement and the consummation of the transactions contemplated hereby; and

(e) neither the execution, delivery and performance of this Agreement by such
Party nor the performance by such Party of its obligations hereunder nor the
consummation by such Party of the transactions contemplated hereby will result
in (i) a material violation of or a conflict with any provision of its
organizational documents, (ii) a material breach or violation of, or a default
under (with or without notice or lapse of time or both) any term or provision
of, or any right of termination, cancellation, modification or acceleration
arising under any contract or by which any of their respective properties or
assets are bound, (iii) a material violation by such Party of any Law or order,
or (iv) the imposition of any encumbrance on the business, properties or assets
of such Party.

17.2 Additional Representations and Warranties of Monogram. Monogram further
represents and warrants to Pfizer as follows, as of the Effective Date:

(a) Monogram owns sufficient rights to Monogram Intellectual Property to perform
its obligations under this Agreement with respect to the US Territory and to
grant Pfizer the license set forth in Article 13. Monogram has not transferred
ownership of, or granted any exclusive license of, or exclusive right to use, or
authorized the retention of any exclusive rights to use, any Monogram
Intellectual Property with respect to any other Person (except as provided
herein).

(b) Annex H hereto contains a list of all licensed third-party intellectual
property licensed to Monogram for use in connection with the Assay. All such
licensed intellectual property is licensed from a party other than Monogram
pursuant to a contract disclosed in Annex H. The Monogram Intellectual Property,
together with the third-party intellectual property identified in Annex H,
constitutes all intellectual property owned, licensed to or controlled by
Monogram or any of its Affiliates that is necessary or useful in the
development, manufacture or use, performance, sale or importation of the Assay
or that claims any Technology relating thereto.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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(c) To the knowledge of Monogram, except as set forth in the SEC Documents (as
defined in the Note Agreement), neither the Monogram Intellectual Property nor
any activities of Monogram is the subject of a notice or claim regarding any
infringement of any such rights.

(d) Neither this Agreement nor the transactions contemplated hereby shall result
in (i) Monogram’s granting to any third party any right with respect to any
Monogram Intellectual Property or, as the case may be, any licensed third-party
intellectual property, and (ii) Monogram being bound by, or subject to, any
non-compete or other restriction on the use of the Monogram Intellectual
Property or, as the case may be, any licensed third-party intellectual property.
Monogram has disclosed to Pfizer all material correspondence and contact
information between it and the United States Food and Drug Administration or any
other similar foreign regulatory authority regarding the Assay.

(e) Monogram has disclosed to Pfizer all material information in Monogram’s
possession related to the performance and reliability of the Assay, and
Monogram’s capabilities to perform the Assay. To the knowledge of Monogram,
after due inquiry, all information provided by Monogram to Pfizer related to the
performance, reliability, capabilities and US Territory reimbursement for the
Commercial Assay is true and correct in all material respects.

(f) Monogram is not a Party to any agreement or other arrangement providing that
other HIV assays will be given priority ahead of the Commercial Assay.

18. INDEMNITIES

18.1 Mutual Indemnification.

(a) Each Party (each, an “Indemnifying Party”) hereby agrees to indemnify and
hold the other Party and its Representatives (each, an “Indemnified Party”)
harmless from and against any and all Third Party claims, liabilities,
obligations, losses, fines, costs, royalties, proceedings, or damages (whether
absolute, accrued, conditional or otherwise), including out-of-pocket expenses
and reasonable attorneys’ and accountants’ fees incurred in the investigation or
defense of any of the same (collectively, “Losses”), resulting from or arising
out of or in connection with any breach of any representation, warranty,
covenant or agreement contained in this Agreement by the Indemnifying Party.

(b) Monogram hereby agrees to indemnify and hold Pfizer and its Representatives
harmless from and against any Losses resulting from or arising out of or in
connection with any accident, illness or personal injury, including death, or
property damage to the extent caused or allegedly caused by, or to the extent
related to, the Commercial Assay, except to the extent it arises from the breach
of this Agreement or the negligence or willful misconduct of Pfizer.

(c) Pfizer hereby agrees to indemnify and hold Monogram and its Representatives
harmless from and against any Losses resulting from or arising out of or in
connection with any

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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accident, illness or personal injury, including death, or property damage to the
extent caused or allegedly caused by, or to the extent related to, the Pfizer
Product, except to the extent it arises from the breach of this Agreement or the
negligence or willful misconduct of Monogram.

18.2 Indemnification Procedures.

(a) Within ninety (90) days following receipt by the Indemnified Party of notice
of any pending or threatened Action, claim or demand by a Third Party (any such
Action, claim or demand, a “Third Party Claim”) which could give rise to a claim
for Losses under Section 18.1, the Indemnified Party shall give notice thereof
to the Indemnifying Party indicating the nature of such claim and the basis
therefor (set forth in as complete and accurate a manner as practicable);
provided, however, that failure to give such notice shall not affect the
indemnification provided hereunder, except to the extent the Indemnifying Party
is materially and adversely prejudiced as a result of such failure.

(b) The Indemnifying Party shall have the right, at its option, to assume the
defense of, at its own expense and by its own counsel reasonably satisfactory to
the Indemnified Party, any such matter involving the asserted liability of the
Indemnified Party as to which the Indemnifying Party shall have acknowledged in
writing to the Indemnified Party its obligation to fully indemnify the
Indemnified Party. If any Indemnifying Party shall, in accordance with the
preceding sentence, undertake to compromise or defend any such asserted
liability, it shall promptly notify the Indemnified Party of its intention to do
so, and the Indemnified Party shall agree to cooperate with the Indemnifying
Party and its counsel in the compromise of, or defense against, any such
asserted liability; provided, however, that the Indemnifying Party shall not
settle any such asserted liability without the prior written consent of the
Indemnified Party; provided, further, however, that the immediately preceding
proviso shall not apply in the case of any settlement which releases the
Indemnified Party completely in connection with such matter and which provides
relief consisting solely of money damages borne by the Indemnifying Party. The
Indemnified Party shall have the right to employ separate counsel and to
participate in the defense of such action or proceeding.

(c) The Indemnifying Party shall bear the reasonable fees, costs and expenses of
one such separate counsel for the Indemnified Party in each jurisdiction and
shall pay such fees, costs and expenses at least quarterly, if, but only if,
(x) the defendants in, or targets of, any such action or proceeding include both
an Indemnified Party and the Indemnifying Party, and such Indemnified Party
shall have reasonably concluded that there may be legal defenses available to it
or to other Indemnified Parties which are different from or additional to those
available to the Indemnifying Party (in which case the Indemnifying Party shall
not have the right to direct the defense of such action or proceeding); (y) the
Indemnifying Party shall not have employed counsel reasonably satisfactory to
such Indemnified Party to represent such Indemnified Party within a reasonable
time after notice of the institution of such action or proceeding; or (z) the
Indemnifying Party shall authorize such Indemnified Party to employ separate
counsel at the Indemnifying Party’s expense. In addition, the Indemnifying Party
shall be liable for the reasonable fees and expenses of one counsel employed by
the Indemnified Party for any period during which the Indemnifying Party has not
assumed the defense thereof. The Indemnified Party and its counsel shall
cooperate with the Indemnifying Party and its counsel and shall not

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

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assert any position in any proceeding inconsistent with that asserted by the
Indemnifying Party; provided, however, that the foregoing shall not prevent the
Indemnified Party from taking the position that it is entitled to
indemnification hereunder. All reasonable out-of-pocket costs and expenses
incurred in connection with an Indemnified Party’s cooperation shall be borne by
the Indemnifying Party. The Indemnified Party shall have the right at its own
expense to participate in the defense of such asserted liability.

18.3 Exclusive Remedy. Without limiting any right or remedy either Party may
have hereunder or in law or equity in respect of any breach of this Agreement
that does not involve a Third Party Claim, and except for fraud, intentional
misrepresentation, or gross negligence by any Party, the foregoing
indemnification provisions are the sole and exclusive remedy for any claim for
monetary relief arising from Losses arising as a result of a breach of this
Agreement.

18.4 Dispute Resolution. Resolution of all disputes arising out of or related to
this Agreement or the performance, enforcement, breach or termination of this
Agreement and any remedies relating thereto, shall be governed by and construed
under the substantive laws of the State of New York, without regard to conflicts
of law rules that would provide for application of the law of a jurisdiction
outside New York. Any such controversy or claim shall be resolved by the United
States District Court for the Southern District of New York, a New York state
court sitting in New York, New York, the United States District Court for the
District of Delaware, or a Delaware state court sitting in Wilmington, Delaware
(collectively, the “Courts”). Each Party (a) irrevocably submits to the
exclusive jurisdiction in the Courts, for purposes of any action, suit or other
proceeding relating to or arising out of this Agreement, and (b) agrees not to
raise any objection at any time to the laying or maintaining of the venue of any
such action, suit or proceeding in any of the Courts, irrevocably waives any
claim that such action, suit or other proceeding has been brought in an
inconvenient forum and further irrevocably waives the right to object, with
respect to such action, suit or other proceeding, that such Court does not have
any jurisdiction over such Party. Monogram hereby irrevocably designates,
appoints and empowers Corporation Service Company, located at 2711 Centerville
Road, Suite 400, Wilmington, DE 19808, as its true and lawful agent and attorney
in fact in its name, place and stead to receive and accept on its behalf service
of process in any action, suit or proceeding in the Courts of New York with
respect to matters as to which it has submitted to jurisdiction as set forth in
the immediately preceding sentence.

19. MISCELLANEOUS

19.1 Insurance. Monogram agrees to procure and maintain in full force and effect
during the Term valid and collectible insurance policies in connection with its
activities as contemplated hereby. Upon Pfizer’s request, Monogram shall provide
Pfizer with a certificate of coverage or other written evidence reasonably
satisfactory to Pfizer of such insurance coverage.

19.2 Non-Exclusivity. This Agreement shall be non-exclusive, and for
clarification, does not prohibit either Party (whether alone or with Third
Parties) from researching, developing or performing any assay (including the
Assay) used in the treatment or diagnosis of HIV.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

37

--------------------------------------------------------------------------------

19.3 Costs, Expenses. Other than as provided herein, each Party shall pay its
own costs, fees and out-of-pocket expenses in connection with the preparation,
execution and delivery of this Agreement and documents contemplated herein.

19.4 No Finders’ Fees. Each Party represents that it neither is nor will be
obligated for any finders’, broker’s, financial advisors’ or other
intermediaries’ fee or commission in connection with this Agreement.

19.5 Amendment and Waivers. Any term of this Agreement may be amended and the
observance of any term of this Agreement may be waived (either generally or in a
particular instance and either retroactively or prospectively), only with the
consent of Pfizer and Monogram. No delay or failure to require performance of
any provision of this Agreement shall constitute a waiver of that provision as
to that or any other instance. No waiver granted under this Agreement as to any
one provision herein shall constitute a subsequent waiver of such provision or
of any other provision herein, nor shall it constitute the waiver of any
performance other than the actual performance specifically waived.

19.6 Successors and Assigns.

(a) Except as otherwise provided in this Agreement, the rights and obligations
of the Parties will be binding upon and inure to the benefit of their respective
successors. Neither this Agreement nor any of the rights, interests or
obligations hereunder may be assigned, in whole or in part, by any Party without
the prior consent of the other Party; provided that Pfizer may assign this
Agreement or any of its rights hereunder to any of its Affiliates without
Monogram’s consent so long as Pfizer continues to be bound by all of its
obligations under this Agreement. Any assignment or purported assignment of this
Agreement in breach of any provision hereof shall be null and void.

(b) Notwithstanding anything in this Agreement to the contrary, if an assignment
by one Party of its rights or obligations under this Agreement leads to the
imposition of any value-added taxes or withholding tax liability on the other
Party resulting from the performance of the Parties obligations under this
Agreement that would not have been imposed in the absence of such assignment or
in an increase in such liability above the liability that would have been
imposed in the absence of such assignment, the assigning Party shall indemnify
and hold harmless the non-assigning Party (or its assignee) from any such
additional or increased tax liability (except to the extent that the
non-assigning Party can reclaim it, provided that the assigning Party reimburses
the non-assigning Party for any reasonable out of pocket costs incurred in the
reclaim). In the event of any such assignment, the assigning Party shall, or
shall cause its assignee to, gross up any payments it makes to the non-assigning
Party to the extent necessary so that the net payment received by the
non-assigning Party after such additional or increased tax liability equals the
amount due under this Agreement.

19.7 Governing Law. This Agreement will be governed by and construed in
accordance with the Laws of the State of New York without giving effect to its
principles or rules of conflict of laws to the extent such principles or rules
would require or permit the application of the laws of another jurisdiction.

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

38

--------------------------------------------------------------------------------

19.8 Severability. If any term or other provision of this Agreement is invalid,
illegal or incapable of being enforced by applicable Law or public policy, all
other terms and provisions of this Agreement shall nevertheless remain in full
force and effect so long as the economic or legal substance of the transactions
contemplated hereby is not affected in any manner materially adverse to any
Party. Upon such determination that any term or other provision is invalid,
illegal or incapable of being enforced, the Parties shall negotiate in good
faith to modify this Agreement so as to effect the original intent of the
Parties as closely as possible in an acceptable manner in order that the
transactions contemplated hereby are consummated as originally contemplated to
the greatest extent possible.

19.9 Entire Agreement. This Agreement and the Amendment to the Master Services
Agreement, including all schedules, annexes and exhibits hereto and thereto
constitute the entire agreement and understanding of the Parties with respect to
the subject matter of this Agreement, and supersede any and all prior
understandings and agreements, whether oral or written, between or among the
Parties with respect to the specific subject matter hereof.

19.10 Notices. Any notices, approvals, or consents required or permitted to be
given under this Agreement shall be in writing, shall specifically refer to this
Agreement and shall be deemed to have been sufficiently given for all purposes
if (i) mailed by first class certified or registered mail, postage prepaid,
internationally recognized overnight courier, (ii) personally delivered, or
(iii) sent via facsimile. Unless otherwise specified in writing, the mailing
addresses and fax numbers of the Parties shall be as described below:

 

For Monogram:    Monogram Biosciences Inc.    345 Oyster Point Boulevard   
South San Francisco, California 94080    Attention: Chief Executive Officer   
Facsimile No: +1 650-635-1111 with a copy to:    Attention: General Counsel   
Facsimile No.: +1 650-635-1111 For Pfizer:    Pfizer Inc.    235 East 42nd
Street    New York, New York 10017    Attention: President, Pfizer Human Health
   Facsimile No.: +1 212-808-8652 with a copy to:    Attention: Vice Chairman,
Executive Vice President and                      General Counsel    Facsimile
No.: +1 212-808-8924

Notices hereunder shall be deemed to be effective (x) upon receipt if personally
delivered or faxed, (y) on the tenth (10th) Business Day following the date of
mailing if sent by first class

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

39

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certified or registered mail, and (z) on the second (2nd) Business Day following
the date of transmission or delivery to the overnight courier if sent by
overnight courier. A Party may change its address or fax number listed above by
sending notice to the other Parties in accordance with this Section 19.10.

19.11 Titles and Headings. The titles, captions and headings of this Agreement
are included for ease of reference only and will be disregarded in interpreting
or construing this Agreement.

19.12 Counterparts. This Agreement may be executed in two or more counterparts,
each of which when so executed and delivered will be deemed an original of the
Party or Parties executing the same, and all of which together shall constitute
one and the same agreement.

19.13 Facsimile Signatures. This Agreement may be executed and delivered by
facsimile and upon such delivery the facsimile signature will be deemed to have
the same effect as if the original signature had been delivered to the other
Party.

19.14 Further Assurances. At any time or from time to time after the Effective
Date, the Parties agree to cooperate with each other, and at the request of any
other Party, to execute and deliver any further instruments or documents and to
take all such further action as the other Party may reasonably request in order
to evidence or effectuate the consummation of the transactions contemplated
hereby and to otherwise carry out the intent of the Parties hereunder. No Party
shall be permitted hereunder to take any action for the purpose of circumventing
the provisions and purposes of this Agreement and the transactions contemplated
hereby.

19.15 Third Parties. Nothing in this Agreement, express or implied, is intended
to confer upon any Person, including any insurer for the benefit of any of the
Parties or such Parties’ Affiliates whether any such insurance relates to the
subject matter of this Agreement or otherwise, other than the Parties and their
successors, any rights or remedies under or by reason of this Agreement.

19.16 Force Majeure. Any Party shall be excused from the performance of their
obligations under this Agreement to the extent that such performance is
prevented by force majeure and the nonperforming Party promptly provides notice
of the prevention to the other Parties. Such excuse shall be continued so long
as the condition constituting force majeure continues. For purposes of this
Agreement, force majeure shall include conditions beyond the control of the
Parties, including an act of God, voluntary or involuntary compliance with any
regulation, law or order of any government, war, terrorist action, civil
commotion, epidemic, failure or default of public utilities or common carriers,
destruction of facilities or materials by fire, earthquake, storm or like
catastrophe. Notwithstanding the foregoing, any payment due and owing hereunder
shall not be delayed by the payer because of a force majeure affecting the
payer, unless such force majeure specifically precludes the payment process. Any
Party claiming relief pursuant to this Section 19.16 shall use commercially
reasonable efforts to minimize the impact of such a force majeure.

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

40

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IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their proper officers as of the date and year first above written.

 

MONOGRAM BIOSCIENCES, INC. By:  

/s/ William D. Young

Name:   William D. Young Title:   Chief Executive Officer PFIZER INC. By:  

/s/ Marie-Caroline Sainpy

Name:   Marie-Caroline Sainpy Title:  

Senior Vice President USP

Marketing and Worldwide Commercial Development

--------------------------------------------------------------------------------

ANNEX A

Performance Standards

Samples from Established Countries

 

Assay Attribute

 

Performance Standards

[*]   [*] [*]  

[*]

[*]

[*]   [*] [*]   [*]

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

A-1

--------------------------------------------------------------------------------

ANNEX B

Monogram Copyrights

None.

 

B-1

--------------------------------------------------------------------------------

ANNEX C

Monogram Patent Rights

 

Matter No.   Country   Application
No.   Filing
Date   Patent
No.   Issue
Date   Title [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*] [*]
  [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]  
[*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*]
[*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]
  [*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*]
[*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]
  [*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*]
[*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]
  [*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*]
[*]   [*]   [*]   [*]       [*] [*]   [*]   [*]   [*]       [*] [*]   [*]   [*]
  [*]       [*]

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

C-1

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ANNEX D

Sample Handling Guidelines

LOGO [g57841img1.jpg]

Procedure for Collection, Handling, and Shipment of Specimens

to Monogram Biosciences, Inc. for

Clinical Research/Pharma Collaborations Testing

(PhenoSense™ HIV, GeneSeq™ HIV, PhenoSenseGT™, PhenoSense™ Entry HIV, GeneSeq™

Entry HIV, and Tropism Assays)

HIV RNA is especially vulnerable to degradation; therefore, proper collection
and handling of blood specimens are essential for successful performance of
these assays.

Specimen Volume Requirements for all assays:

 

•   3.0 mL of frozen EDTA plasma (lavender top or PPT).

 

NOTE:    The PhenoSense™ HIV, GeneSeq™ HIV, and PhenoSenseGT™ assays may be
performed on the same 3 mL specimen. Only one specimen needs to be submitted if
all assays are to be performed. An additional 3 mL specimen must be submitted
for the PhenoSense™ Entry HIV, GeneSeq™ Entry HIV, and Tropism assays.    The
PhenoSense™ HIV, GeneSeq™ HIV, and PhenoSenseGT™ assays are validated for
testing specimens with HIV-1 viral loads equal to or greater than 500 copies/mL.
The PhenoSense™ Entry HIV, GeneSeq™ Entry HIV, and Tropism assays require a
minimum plasma HIV-1 viral load equal to or greater than 1,000 copies/mL.

Specimen Collection and Processing:

 

•   Draw whole blood in a sterile tube containing EDTA anticoagulant (lavender
top or PPT).

 

•   Centrifuge blood within 6 hours of collection at 1000-1200 x g at room
temperature for 10-15 minutes. (PPT must be spun within two hours of
collection.)

 

•   Immediately transfer plasma to a screw-top plasma tube and freeze
immediately at or below -20o C. (PPT should be frozen immediately after
centrifugation at or below -20o C.)

 

•   DO NOT THAW SAMPLE AFTER FREEZING!

Specimen Packaging and Shipping:

 

•   Plasma must be transported frozen on dry ice. Properly package specimens to
ensure safe arrival to Monogram Biosciences.

 

•   Transportation of whole blood or plasma must comply with federal, state,
county, and local regulations for the transport of infectious agents.

 

•   Enclose a completed sample list with patient information for each specimen
with each shipment.

 

•   Notify Monogram Biosciences of specimen shipment by e-mail. E-mail the
following information to -receiving@monogrambio.com

 

  •   Number of specimens enclosed

 

  •   Your name and phone number

 

  •   Airbill number

 

  •   Study name

 

  •   Name of courier service

 

  •   Ship specimens to Monogram Biosciences to allow for receipt on Monday
through Saturday only.

If shipping on Friday, please check airbill for Saturday delivery.

 

•   If delivery will occur or be affected by a holiday, please call your
Monogram Biosciences Project Manager at (650) XXX-XXXX to ensure proper
delivery.

 

D-1

--------------------------------------------------------------------------------

•   Complete the airbill and prepare the package for shipment in compliance with
Diagnostic Specimens IATA Packaging Instruction 650. Please note the IATA
shipper’s responsibility: The shipper is required to comply with the rules and
guidelines for transport of Infectious Substances and to ensure that shipments
comply with ICAO and IATA regulations.

 

•   If the HIV samples are cultured or amplified in any way, then ship the
samples as infectious substances and include the Shipper’s Declaration of
Dangerous Goods.

 

•        Ship all specimens to the following address: 

  Monogram Biosciences, Inc.   345 Oyster Point Boulevard   South San Francisco,
CA 94080   Attn: Project Manager   Phone: (650) XXX-XXXX   Fax: (650) 624-4457

 

D-2

--------------------------------------------------------------------------------

ANNEX E

Examples of Fulfillment Standards under Section 2.3

 

US Coverage Levels

 

% Samples Covered by MGRM

(evaluated quarterly)

[*]   [*] [*]   [*] [*]   [*] [*]  

 

Scenario #1           Comments [*]   [*]     [*]     [% Tests]   [*]   [*]   [*]
  [*] [*]   [*]   [*]   [*]   [*]   [*]   Scenario #2             [*]   [*]    
[*]     [*]   [*] [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   Scenario
#3             [*]   [*]     [*]     [*]   [*] [*]   [*]   [*]   [*]   [*]   [*]
  [*]   [*]   [*]  

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

E-1

--------------------------------------------------------------------------------

ANNEX F

 

  Pfizer:    Kate Robins      860-732-9684   Monogram:    Alfred G. Merriweather
     650 624 4576

Pfizer and Monogram to Make HIV Co-Receptor Tropism Assay Available Globally

Understanding HIV’s co-receptor usage may facilitate targeting of drugs to
appropriate patients

New York, NY and South San Francisco, CA, May 8, 2006 — Pfizer Inc. and Monogram
Biosciences, Inc. announced today a non-exclusive collaboration to make
Monogram’s HIV Co-Receptor Tropism Assay available for patient use on a global
basis. The assay is a diagnostic tool to show tropism – the path taken by the
virus to access human CD4 cells.

Tropism information is intended to help identify patients who are most likely to
respond to a class of investigational drugs known as CCR5 antagonists. CCR5
antagonists are designed to block viral cell entry through the CCR5 co-receptor.
Studies have shown that 80-85 percent of people newly diagnosed with HIV and
previously untreated with HIV therapy have dominant CCR5-tropic virus. This
drops to 50-60 percent in patients who have been treated before with
anti-retroviral medicines.

Pfizer has a CCR5 antagonist, maraviroc, in phase 3 development and has used the
Monogram tropism assay to select patients for enrolment in late-stage clinical
studies. The agreement announced today expands this clinical trial collaboration
and provides for global availability of Monogram’s assay in a multi-year
collaboration.

“Because of the important role the Co-Receptor Tropism Assay is believed to play
in CCR5 antagonist clinical development, we are pleased to be expanding our
partnership with Pfizer. We look forward to working together so that the right
medicine can be made available to the right patients at the right time” said
William D. Young, Monogram CEO.

 

F-1

--------------------------------------------------------------------------------

Under the terms of the agreement announced today, Pfizer and Monogram will
collaborate to make Monogram’s Co-Receptor Tropism Assay available globally.
Pfizer also entered into an agreement to invest $25 million in Monogram this
month through a Senior Secured Convertible Note, payable in May 2010. The
closing of the investment is subject to customary closing conditions.

“CCR5 antagonists have a mechanism of action different from currently approved
drugs,” said John LaMattina, president, Pfizer Global Research and Development.
“With this collaboration we are working to advance global access to new
diagnostics that may better assess the potential for CCR5 antagonists to fulfill
an unmet medical need.”

About Pfizer

Pfizer is committed to bringing meaningful improvement to the lives of people
living with HIV/AIDS and those at risk around the world. Our commitment is
embodied in our products, partnerships, pipeline and philanthropy.

Pfizer Global Research & Development is the world’s largest privately owned
biomedical research organization. Pfizer Inc discovers, develops, manufactures
and markets leading prescription medicines, for humans and animals, and many of
the world’s best-known consumer brands.

About Monogram

Monogram is advancing individualized medicine by discovering, developing and
marketing innovative products to guide and improve treatment of serious
infectious diseases and cancer. The Company’s products are designed to help
doctors optimize treatment regimens for their patients that lead to better
outcomes and reduced costs. The Company’s technology is also being used by
numerous biopharmaceutical companies to develop new and improved antiviral
therapeutics and vaccines as well as targeted cancer therapeutics. More
information about the Company and its technology can be found on its web site at
www.monogrambio.com.

 

F-2

--------------------------------------------------------------------------------

ANNEX G

Reports

 

Agreement
Section   Report   Frequency [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]   [*]
  [*]   [*] [*]   [*]   [*]   [*]   [*]   [*]   [*] [*]   [*]   [*]   [*]   [*]
  [*]   [*]   [*]   [*]

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

G-1

--------------------------------------------------------------------------------

ANNEX H

Third-Party Intellectual Property

License Agreement by and among Grantor and University of Iowa Research
Foundation, dated August 25, 2005, for Patent No. 5,168,062, titled “Transfer
Vectors and Microorganisms Containing Human Cytomegalovirus (HCMV)
Immediate-Early Promoter DNA Sequence.”

License Agreement by and among Grantor and University of Iowa Research
Foundation, dated August 25, 2005, for Patent No. 5,385,839, titled “Transfer
Vectors and Microorganisms Containing Human Cytomegalovirus (HCMV)
Immediate-Early Promoter DNA Sequence.”

License Agreement by and among Grantor and NIH, dated January 1, 1996, for
Patent No. 5,252,477, titled “Human Immunodeficiency Virus Specific Proteolytic
Enzyme and a Method for its Synthesis and Renaturation.”

License Agreement by and among Grantor and NIH, dated January 1, 1996, for
Patent No. 5,843,638, titled “Nucleic Acids and Peptides of Human
Immunodeficiency Virus Type-1 (HIV-1).”

 

H-1

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ANNEX I

Maximum Number of Infrastructure Plans Per Calendar Year

 

•   [*]

[*]

 

•   [*]

 

[*] =   CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

I-1