Document:

Exhibit 10.12

 

PRODUCT LICENSE AND COLLABORATION AGREEMENT

 

This Product License and Collaboration Agreement (this “Agreement”)
is made and entered into as of this 4 day of May, 2007 (the “Effective Date”),
by and between (i) BG Medicine, Inc., a Delaware corporation (“BGM”), (ii)
ACS Biomarker B.V. i.o. (“ACSB”), a corporation to be established by the
University of Maastricht (the “University”), BioMedbooster B.V., a corporation
organized under the laws of The Netherlands (“BioMedbooster”), Yigal
Pinto, Mat Daemen, Tilman Hackeng and Marcel Kannekens, and (iii) solely for
purposes of Section 3.04 hereof, the University and BioMedbooster.

 

WHEREAS, the University and BioMedbooster have committed to grant to ACSB
certain Intellectual Property Rights (as defined below) and capabilities in the
field of cardiac disease markers, in particular in the area of heart failure;

 

WHEREAS, BGM owns advanced proteomic and metabolomic capabilities that
are applied for biomarker discovery and validation; and

 

WHEREAS, BGM and ACSB (each, a “Party”), are interested in BGM’s
licensing certain intellectual property rights owned by ACSB on an exclusive
basis in exchange for certain royalty payments, and in pursuing an alliance for
the detection and validation of markers in congestive heart failure and other
areas;

 

NOW, THEREFORE, in consideration of the mutual premises and covenants
herein contained and other good and valuable consideration, the receipt and
adequacy of which are hereby acknowledged, the Parties and the other parties
hereto hereby agree as follows:

 

ARTICLE I

DEFINITIONS

 

As used herein, the following terms shall have the following meanings:

 

(a)           “ACSB Marker Notice” shall have the meaning
set forth in Section 4.02(b).

 

(b)           “Affiliate” shall mean, with respect to a Person,
any (i) corporation, firm, partnership or other entity which directly or
indirectly controls such Person, (ii) corporation, firm, partnership or other
entity which is controlled by or is under common control with such Person,
(iii) corporation, firm, partnership or other entity which is controlled by a
corporation, firm, partnership or other entity as defined in (i) above, or (iv)
corporation, firm, partnership or other entity which is controlled by a
corporation, firm, partnership or other entity as defined in (iii) above. For
purposes of this definition, “control” means ownership, directly or through one
or more Affiliates, of (a) more than fifty percent (50%) of the shares of stock
entitled to vote for the election of directors, in the case of a corporation,
(b) more than fifty percent (50%) of the equity interests in the case of any
other type of legal entity, status as a general partner in any partnership, or
(c) any other arrangement whereby a Party controls or has the right to control
the Board of Directors or equivalent governing body of a corporation or other
entity.

 

(c)           “BGM Project Notice” shall have the meaning
set forth in Section 4.01.

 

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

 

(d)           “CARIM” shall mean the Cardiovascular
Research Institute Maastricht.

 

(e)           “Confidential Information” shall mean all
trade secrets, proprietary information, know-how, data, designs,
specifications, processes, customer lists and other technical or business
information (and any tangible evidence, record or representation thereof),
including without limitation any idea, improvement, invention, innovation,
development, concept, technical data, design, formula, device, pattern,
sequence, method, process, composition of matter, product specification or
design, plan for a new or revised product, sample, compilation of information,
or work in process, or parts thereof, and any and all revisions and
improvements relating to any of the foregoing (in each case whether or not
reduced to tangible form).

 

(f)            “Field of Interest” shall mean such fields as
BGM and ACSB shall mutually agree and set forth in any Licensing Addendum.

 

(g)           “First Commercial Sale” of a Subject Product
shall mean the first sale of such Subject Product by BGM, its Affiliate or its
Sublicensee(s), for end use or consumption, after all required Regulatory Approvals
have been granted by the applicable Regulatory Authorities.

 

(h)           “First Look Right” shall have the meaning set
forth in Section 4.01.

 

(i)            “GAAP” shall mean U.S. generally accepted
accounting principles, consistently applied.

 

(j)            “Intellectual Property Rights” shall mean any
and all rights in Intellectual Property.

 

(k)           “Intellectual Property” shall mean all
patents, patent applications, the right to apply for patents, trademarks,
trademark applications, service marks, tradenames, copyrights, trade secrets,
licenses, sublicenses, domain names, mask works, information and other
proprietary rights and processes recognized anywhere in the world.

 

(l)            “Licensing Addendum” shall have the meaning
set forth in Section 2.01.

 

(m)          “Marker” shall mean a biochemical
characteristic that is objectively measured and evaluated as an indicator of
normal biologic or pathogenic processes or pharmacological responses to a
therapeutic intervention.

 

(n)           “Net Sales” shall mean, with respect to a
particular Subject Product, the actual gross amount invoiced by BGM or its
Affiliates for commercial sales of such Subject Product after deducting, in
accordance with GAAP, the following:

 

(i)            trade, cash and quantity discounts reasonably
consistent with industry standards;

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

2

 

(ii)           credits or allowances for damaged or spoiled
product, returns, recalls or rejections of products, including allowance for
breakage or spoilage;

 

(iii)          sales, value added, excise or other direct taxes,
and freight, postage, shipping and transportation insurance charges and
additional transportation, custom duties, and other governmental charges on the
Subject Product; and

 

(iv)          chargebacks, rebates or similar payments or credits directly
related to the Subject Product consistent with reasonable industry standards
granted to managed health care organizations, wholesalers, distributors, buying
groups, retailers, health care insurance carriers, pharmacy benefit management
companies, health maintenance organizations or other institutions or health
care organizations or to federal, state/provincial, local and other
governments, their agencies and purchasers and reimbursers.

 

Sales or other transfers between BGM and its
Affiliates shall be excluded from the computation of Net Sales and no payments
will be payable on such sales or transfers except where such Affiliates are end
users, but Net Sales shall include the subsequent sales to Third Parties by
such Affiliates. Where an Affiliate is the end user, Net Sales shall be deemed
to be equal to the average per-unit price charged to Third Parties for the same
Subject Product during the relevant calendar half-year multiplied by the number
of units sold or transferred to the Affiliate during such calendar half-year.

 

(o)           “Person” shall mean any individual,
corporation, partnership, limited liability company, firm, joint venture,
association, joint-stock company, trust, unincorporated organization or other
entity.

 

(p)           “Regulatory Approval” means all approvals and
clearances of Regulatory Authorities (including where applicable pricing and
reimbursement approvals required for marketing authorization), product and/or
establishment licenses, registrations or authorizations necessary for the
manufacture, use, storage, import, export, transport and marketing and/or sale
of a Subject Product in a particular jurisdiction.

 

(q)           “Regulatory Authority” shall mean the FDA in
the U.S., and the EMEA or any agency in the European Union and any health
regulatory authority(ies) in any other country(ies) that is equivalent to the
FDA and holds responsibility for granting Regulatory Approval for a Subject Product
in such country(ies), and any successor(s) thereto having substantially the
same functions.

 

(r)            “Right of First Offer” shall have the meaning
set forth in Section 4.02.

 

(s)           “Royalty Statement” shall have the meaning
set forth in Section 2.02(g).

 

(t)            “Subject BGM Project” shall mean any
Marker-related research or development project initiated by BGM within the
Field of Interest for which ACSB, CARIM or the University could, in the
reasonable judgment of BGM, be a qualified investigator or collaborator.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

3

 

(u)           “Subject IP” shall mean any Intellectual
Property Rights identified as Subject IP in a Licensing Addendum.

 

(v)           “Subject Markers” shall have the meaning set
forth in Section 4.02.

 

(w)          “Subject Products” shall have the meaning set
forth in Section 2.02(a)(i).

 

(x)            “Sublicense Non-Royalty Payments” shall mean
any payments received by BGM from Sublicensees as consideration for the grant
of a Sublicense, including without limitation, license fees, technology fees,
milestone payments and license maintenance fees, but excluding amounts received
by BGM (i) as Sublicense Royalty Payments; (ii) as dollar-for-dollar
reimbursement for or prepayment of BGM’s research and development expenses incurred
in connection with the applicable Subject IP, as determined in accordance with
GAAP; or (iii) for a Sublicensee’s purchase of securities of BGM.

 

(y)           “Sublicense Royalty Payments” shall mean
payments received by BGM from Sublicensees as consideration for the grant of
such sublicense that are based on net sales of Subject Products by such
Sublicensee.

 

(z)            “Sublicense” shall mean a sublicense to
Subject IP granted by BGM, as well as any sublicense granted by the sublicensee
of such Sublicense.

 

(aa)         “Sublicensee” shall mean any Person to whom
BGM grants a Sublicense, as well as any entity to which such Person grants a
Sublicense

 

(bb)         “Sublicensing Income” shall, with respect to
any particular Subject IP, all Sublicense Non-Royalty Payments and Sublicense
Royalty Payments generated from such Subject IP.

 

(cc)         “Third Party(ies)” shall mean a Person who or
which is neither a Party nor an Affiliate of a Party.

 

(dd)         “University” shall mean the University of
Maastricht.

 

(ee)         “Valid Claim” means a claim of an issued and
unexpired patent, which has not been revoked or held unenforceable or invalid
by a decision of a court or other governmental agency of competent
jurisdiction, and which has not been disclaimed or surrendered through reissue
or disclaimer.

 

ARTICLE II

LICENSE, ROYALTIES AND COLLABORATION

 

Section 2.01           License of Subject IP. BGM shall have, and ACSB hereby grants to BGM, a
license to any and all Intellectual Property Rights as may be agreed by the
Parties and set forth from time to time in one or more addenda to this
Agreement on the terms set forth

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

4

 

herein and
on such additional terms as may be set forth in such addenda. Any such
Intellectual Property Rights are sometimes hereinafter referred to as “Subject
IP,” and any such addendum is sometimes hereinafter referred to as a “Licensing
Addendum.”  The Parties shall use the
form attached hereto as Exhibit A as the template for each Licensing
Addendum. The license so granted with respect to the Subject IP identified in
any particular Licensing Addendum (each, a “License”) shall be on the
following terms, except as otherwise provided in such Licensing Addendum:

 

(a)           Exclusivity. Such License shall be exclusive or non-exclusive
as set forth in the applicable Licensing Addendum; provided,
however, that the University, ACSB, BioMedbooster  and each of their respective Affiliates shall
have a limited, non-exclusive license, without the right to grant sublicenses,
to use any Subject IP solely for internal research and teaching purposes.

 

(b)           Field of Use. Such License shall entitle BGM to use and exploit
the applicable Subject IP for the purpose or purposes as set forth in the
applicable Licensing Addendum.

 

(c)           Term. Such License shall be for the term specified in
the applicable Licensing Addendum.

 

(d)           Sublicensing. Such License shall include the right to grant Sublicenses
as set forth in the applicable Licensing Addendum.

 

(e)           Territory. Such License shall be valid in the countries
specified in the applicable Licensing Addendum.

 

(f)            Royalties. BGM shall pay ACSB royalties with respect to the
use of the applicable Subject IP on the terms set forth in Section 2.02
below.

 

Section 2.02           Royalties.

 

(a)           Payments in Respect of Net Sales.

 

(i)            If BGM shall sell any products based on any Subject
IP (each, a “Subject Product”), and such sale would, absent the License
granted hereunder with respect to such Subject IP, infringe one or more Valid
Claims with respect to such Subject IP, BGM shall pay ACSB a royalty equal to
such percentage (if any) of Net Sales of such Subject Product, and upon such
additional terms and conditions, as shall be set forth in the Licensing
Addendum in which the applicable Subject IP is identified. If such Valid Claims
relate to Subject IP identified in two or more Licensing Addenda, the royalty
to be paid to ACSB shall be determined using the average of the applicable
percentages set forth in all such Licensing Addenda.

 

(ii)           Limitations on Royalties on Net Sales. The payment of royalties with respect to Subject
Products under this Agreement shall be subject to the following conditions:

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

5

 

1)      Royalties on Net Sales of a particular Subject
Product at the rates set forth above shall accrue as of the date of First
Commercial Sale of such Subject Product and shall continue and accrue until the
expiration of the last to expire Valid Claim relating to such Subject Product. Thereafter,
BGM shall be relieved of any royalty payment with respect to such Subject
Product.

 

2)      No royalties shall accrue on the disposition of
reasonable quantities of Subject Products by BGM, Affiliates or Sublicensees as
samples (promotion or otherwise) or as donations (for example, to non-profit
institutions or government agencies) or to clinical trials.

 

(b)           Payments in the Event of Sublicense. In the event BGM enters into a Sublicense with a
Third Party granting to the Sublicensee a sublicense under any rights granted
to BGM pursuant to a License of any Subject IP hereunder (the “Sublicensed
Rights”), BGM’s obligation to pay royalties under Section 2.02(a)
above with respect to the Sublicensed Rights subject to the Sublicense shall
terminate and, in lieu thereof, BGM shall pay to ACSB such percentage of all
Sublicensing Income received by BGM from the Third Party Sublicensee with
respect to the Sublicensed Rights subject to the Sublicense, and upon such
additional terms and conditions, as shall be set forth in the Licensing
Addendum in which the applicable Subject IP is identified. subject. To the
extent the Sublicensed Rights do not include all of the rights granted to BGM with
respect to the applicable Subject IP, ACSB shall continue to be entitled to royalties
under Section 2.02(a) with respect to those rights retained by BGM or
its Affiliates and not subject to the Sublicense. Amounts payable to ACSB based
on Sublicensing Income shall be payable for the same term as royalties would
have been payable pursuant to Section 2.02(a)(ii)1) above.

 

(c)           Affiliate Sales. In the event that BGM transfers Subject Products
to one of its Affiliates, there shall be no royalty due at the time of transfer.
Subsequent sales of Subject Products by the Affiliate to end users (which are
not Sublicensees) shall be reported as Net Sales hereunder by BGM.

 

(d)           Compulsory Licenses. If a compulsory license is granted to a Third
Party with respect to any Subject Product in any country with a royalty rate
lower than the royalty rate provided by Section 2.02(a)(i), then the
royalty rate to be paid by BGM on Net Sales of such Subject Product in that
country under Section 2.02(a)(i) shall be reduced to the rate paid by
the compulsory Third Party licensee.

 

(e)           Third Party Licenses. If one or more licenses from a Third Party or
Third Parties are obtained by BGM with the prior or subsequent approval of ACSB,
which approval shall not be unreasonably withheld,  in order to make, have made, use, sell or import any
Subject Product, the royalties or other payments payable by BGM to ACSB under Section
2.02(a) or Section 2.02(b) hereof, as applicable, shall be reduced
by an amount equal to the aggregate royalty payments payable to such Third
Party(ies) in connection with such Subject Product.

 

(f)            Combination Product. Notwithstanding the provisions of Section
2.02(a), in the event a Subject Product is sold as a combination product
with other components, Net Sales, for purposes of royalty payments on the
combination product, shall be calculated by multiplying the Net Sales of that
combination product by the fraction A/B, where A is the gross selling price of

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

6

 

the Subject Product
sold separately and B is the gross selling price of the combination product. If
no such separate sales are made by BGM or its Affiliates, Net Sales for royalty
determination shall be calculated by multiplying Net Sales of the combination
product by the fraction C/(C+D), where C (excluding the fully allocated cost of
the other component in question) is the fully allocated cost of the component
based on Subject IP and D is the fully allocated cost of such other components.

 

(g)           Report of Amounts Due. Within 60 days after the end of each calendar
half-year of BGM, BGM shall deliver to ACSB a statement of its calculation of
Net Sales and Sublicensing Income derived from sales or licensing of Subject
Products during such calendar half-year and any amounts due ACSB with respect
thereto, calculated as set forth in Section 2.02(a) (each such
statement, a “Royalty Statement”). BGM shall preserve, and shall cause
its Affiliates to preserve, all books and records relevant to the preparation
of each Royalty Statement for a period of at least five years after the
delivery of such Royalty Statement to ACSB, and ACSB will be entitled to
appoint an external auditor to verify whether the Royalty Statement is in
accordance with such books and records. On reasonable notice and during regular
business hours, BGM will provide such auditor full access to all such books and
records and will provide such assistance to enable such verification as such
auditor may reasonably request. BGM shall use commercially reasonable efforts
to include audit and books and records preservation provisions similar to those
set forth in this subsection in any Sublicenses that it shall grant.

 

(h)           Timing and Method of Payment. BGM shall pay ACSB any amounts due with respect to
a particular calendar half-year by wire transfer to a bank account designated
by ACSB within 30 days following delivery of the Royalty Statement for such
year. To the extent any amounts due are to be offset against any prepayments of
royalties that BGM shall have made, BGM shall, in lieu of paying such amounts,
send ACSB written notice of such offset.

 

(i)            Payment Exchange Rate. All payments to ACSB under this Agreement shall be
made in Euros unless otherwise agreed by the Parties. In the case of sales
outside the United States, the rate of exchange to be used in computing Net
Sales and Sublicensing Income shall be calculated monthly in accordance with
GAAP and based on the conversion rates published in the Wall Street Journal,
Eastern edition (if available).

 

(j)            Tax Withholding. For so long as ACSB is domiciled in The
Netherlands and BGM is domiciled in the United States of America, all sums
payable under or by virtue of this Agreement and to be received by ACSB shall
be free from any deduction by any authority other than government authorities
of The Netherlands in respect of taxes, import duties, or other charges and
except for those withholding taxes (and other deductible taxes in The
Netherlands) payable by law in The Netherlands which ACSB (in accordance with
the Double Tax Treaty between The Netherlands and the US) can recover from the
Dutch Tax authorities, in which case BGM shall provide all necessary assistance
and shall make available to ACSB the original tax receipts thereof promptly
upon payment.

 

(k)           Exchange Controls. Notwithstanding any other provision of this
Agreement, if at any time legal restrictions prevent the prompt remittance of
part or all of the payments set forth

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

7

 

in this ARTICLE
II in any country, payment shall be made through such lawful means or
methods as BGM may determine after consultation with ACSB. When in any country
the law or regulations prohibit both the transmittal and deposit of royalties
on sales in such a country, royalty payments shall be suspended for as long as
such prohibition is in effect (and such suspended payments shall not accrue
interest), and, promptly after such prohibition ceases to be in effect, all
royalties or other payments that BGM would have been obligated to transmit or
deposit, but for the prohibition, shall be deposited or transmitted, as the
case may be, to the extent allowable (with any interest earned on such
suspended royalties which were placed in an interest-bearing bank account in
that country, less any transactional costs). If the royalty rates specified in
this Agreement should exceed the permissible rate established in any country,
the royalty rate for sales in such country shall be adjusted to the highest
legally permissible or government-approved rate.

 

Section 2.03           Development Activities. Each Licensing Addendum may provide for the
Parties to undertake activities relating to the development and
commercialization of the Subject IP identified in such Licensing Addendum on
the terms set forth therein.

 

Section 2.04           Termination of License on Discontinuance of Product. If BGM shall, at any time after the First
Commercial Sale of a Subject Product, discontinue the production and sale of
such Subject Product and of any other Subject Products that are based upon the
same Subject IP as such Subject Product, then any License granted by ACSB to
such Subject IP shall terminate and BGM shall provide ACSB with access to all
biological and clinical data in BGM’s possession that were generated from such
Subject IP.

 

ARTICLE III

INTELLECTUAL PROPERTY RIGHTS AND PROTECTION

 

Section 3.01           Ownership of Subject IP. Intellectual Property Rights belonging to ACSB at
the time a Licensing Addendum is executed with respect thereto shall remain the
property of ACSB. Ownership of Intellectual Property Rights developed jointly
by the Parties pursuant to activities undertaken pursuant to this Agreement
shall be determined in accordance with inventorship as determined by United
States patent law as if the subject inventions had been wholly made within the
United States; provided, however, that any such
Intellectual Property Rights belonging to ACSB shall be Subject IP and therefore
subject to a License on the terms and conditions of this Agreement and the
applicable Licensing Addendum. Nothing in this Agreement is intended to grant
ACSB ownership or any other rights with respect to any Intellectual Property
Rights now or hereafter owned by BGM.

 

Section 3.02           Patent Prosecution. Unless otherwise provided in the applicable
Licensing Addendum, ACSB shall prepare, file, prosecute and maintain all patents
and patent applications covering any invention related to Subject IP, pursuant
to such strategies and using such patent counsel as ACSB and BGM shall mutually
agree. The Parties shall collaborate and cooperate in good faith regarding all
such matters, and ACSB shall not make any filing or take any other material
action related thereto without the prior approval of BGM. BGM shall reimburse
ACSB

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

8

 

for all
reasonable and customary third-party costs of such patent preparation, filing,
prosecution and maintenance upon receipt of appropriate supporting
documentation.

 

Section 3.03           Infringement  of Subject IP by Third Parties.

 

(a)           Each Party shall promptly give the other Party
notice of any actual or threatened infringement of any Subject IP by any Third
Party that comes to such Party’s attention. The Parties will thereafter consult
and cooperate fully to determine a course of action, including, without
limitation, the commencement of legal action by any Party against any such
Third Party. However, BGM shall have the first right to initiate and prosecute
such legal action at its own expense and in the name of BGM and ACSB. BGM shall
promptly inform ACSB if BGM elects not to exercise such first right, and ACSB
thereafter shall have the right either to initiate and prosecute such action in
the name of ACSB and, if necessary, BGM. In no event shall BGM be obligated to
enforce or defend any of the Subject IP. Neither Party shall enter into any
settlement or compromise of any claim relating to the Subject IP without the
consent of the other Party, which consent shall not be unreasonably withheld. BGM
makes no representation or warranty that it will be able to obtain satisfactory
results from any such legal action and BGM shall have no liability hereunder
with respect to any legal action pursued or not pursued.

 

(b)           The costs of any legal action described in Section
3.03(a) shall be borne by the Party that initiates such action (and subject
to recovery by such Party as provided in Section 3.03(d) below).

 

(c)           For any such legal action or defense, in the event
that any Party is unable to initiate, prosecute, or defend such action solely
in its own name, the other Party will join such action voluntarily and will
execute all documents necessary for the Party to prosecute, defend and maintain
such action. In connection with any such action, the Parties will cooperate
fully and will provide each other with any information or assistance that
either reasonably may request.

 

(d)           Any recovery obtained by either Party shall be
shared as follows:

 

(i)            the Party that initiated and prosecuted, or
maintained the defense of, the action shall recoup all of the costs and
expenses (including reasonable attorneys’ fees) incurred by such Party in
connection with the action, whether the recovery is by settlement or otherwise;

 

(ii)           the other Party then shall, to the extent possible,
recover all of the costs and expenses (including reasonable attorneys’ fees)
incurred by such Party in connection with the action; and

 

(iii)          any remaining amount shall be deemed to be revenues
from the sale of Subject Products based on the Subject IP to which such recovery
relates, and royalties shall be payable on any Net Sales Profits that result
from such deemed revenues according to the percentages (if any) provided in the
Licensing Addendum in which such Subject IP is identified. If such Subject IP
is identified in two or more Licensing Addenda, the royalty to be paid shall be
equal to the average of the applicable percentages set forth in all such Licensing
Addenda.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

9

 

Section 3.04           Indemnification by BGM.

 

(a)           BGM shall indemnify, defend and hold ACSB, the
University, CARIM and BioMedbooster and each of their respective directors,
officers, employees and agents (each, an “Indemnified Party”) harmless
from and against all claims or suits by Third Parties arising out of (i) the
alleged infringement of Intellectual Property Rights owned by a Third Party
resulting from any use by BGM or its Affiliates of any Subject IP or (ii) the
development, manufacture, use, handling, storage, sale or other disposition by BGM
or its Affiliates of any Subject Products; provided,
however, that BGM’s obligation to indemnify under this Section 3.04 shall
not apply to any claim arising out of the gross negligence or willful
misconduct of an Indemnified Party.

 

(b)           ASCB shall give prompt written notice to BGM of any
suits, claims or demands which may give rise to any matter for which
indemnification may be required under this Section 3.04; provided, however, that failure to give such notice shall
not relieve BGM of its obligation to provide indemnification hereunder except,
if and to the extent that such failure materially affects the ability of BGM to
defend the applicable suit, claim or demand. BGM shall be entitled to assume
the defense and control of any such suit, claim or demand at its own cost and
expense. In the event that BGM declines to or fails to timely assume control of
any such suit, claim or demand, the Indemnified Party or Indemnified Parties
entitled to indemnification shall be entitled to assume such control, conduct
the defense of, and settle such suit, claim or action, all at the sole cost and
expense of BGM. Neither BGM nor any Indemnified Party shall settle or dispose
of any such matter in any manner which would adversely affect the rights or
interests of the other party without the prior written consent of such other party,
which shall not be unreasonably withheld or delayed. BGM and each Indemnified
Party shall cooperate with each other and their respective counsel in the
course of the defense of any such suit, claim or demand, such cooperation to
include without limitation using reasonable efforts to provide or make
available documents, information and witnesses.

 

Section 3.05           Regulatory Matters. BGM shall own, control and retain primary legal
responsibility for the preparation, filing and prosecution of all filings and
regulatory applications required to obtain authorization to commercially
develop, sell and use any Subject Products. Upon BGM’s request, ACSB shall
consult and cooperate with BGM in connection with any such matters, and BGM
shall reimburse ACSB for any out of pocket expenses reasonably incurred by ACSB
in connection with such consultation and cooperation.

 

Section 3.06           Agreement Not to Challenge; Further Assurances. ACSB shall not challenge, in any court or
proceeding, or assist any Third Party in challenging, the validity of any
Subject IP or BGM’s ownership of and/or rights therein. ACSB shall further sign
such additional and further documents, and take such other actions, as may be
reasonably requested by BGM to create, perfect, confirm and enforce BGM’s
rights in Subject IP.

 

Section 3.07           Data, Publications and Reports. ACSB shall, as and to the extent requested by BGM,
provide BGM with copies of all biological and clinical data, publications,
reports and other information in ACSB’s possession relating to any Subject IP
in order to support BGM’s efforts to develop, register and commercialize such
Subject IP and otherwise in connection with the exercise of BGM’s rights under
this Agreement.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the Securities
Act.

 

10

 

ARTICLE IV

RIGHTS WITH RESPECT TO NEW PROJECTS AND
DISCOVERIES

 

Section 4.01           First Look Right of ACSB. Before seeking, negotiating or soliciting offers
from Third Parties to act as investigators or collaborators in any Subject BGM
Project, BGM shall give written notice of such Subject BGM Project to ACSB (a “BGM
Project Notice”), and shall provide ACSB with such additional information
regarding such Subject BGM Project as ACSB shall reasonably request for the
purpose of evaluating its interest therein within five (5) days following
delivery of such BGM Project Notice. No later than ten (10) days following
receipt of the applicable BGM Project Notice or, if later, five (5) days
following receipt of any additional information requested by ACSB in response
to such BGM Project Notice as described above, ACSB may give written notice to
BGM that it wishes to negotiate a role for itself, CARIM or the University as
an investigator or collaborator in connection with such Subject BGM Project (a “First
Look Right”) on terms that are consistent with the terms of this Agreement.
If ACSB so exercises its First Look Right with respect to a Subject BGM
Project, the Parties shall negotiate exclusively (but solely as to such role as
BGM reasonably anticipates may be filled by ACSB, CARIM and/or the University)
and in good faith, for a period of up to thirty (30) days after such exercise,
the terms of an agreement (which may take the form of a Licensing Addendum)
pursuant to which ACSB, CARIM and/or the University shall provide project or
collaboration services for such Subject BGM Project; provided,
that no Party shall have any obligation to enter into any such agreement. If,
with respect to a particular Subject BGM Project, ACSM does not so exercise its
First Look Right or such an agreement is not entered into within such 30-day
period, then BGM shall be free to approach Third Parties with respect to, and
otherwise to conduct, such Subject BGM Project without further obligation to
ACSB.

 

Section 4.02           Right of First Offer of BGM.

 

(a)           If ACSB shall discover or acquire rights to any new
Markers (“Subject Markers”), ACSB shall grant BGM a right to negotiate a
Licensing Addendum identifying such Markers as Subject IP (a “Right of First
Offer”) on the terms set forth herein.

 

(b)           Before seeking, negotiating or soliciting offers
from Third Parties for any agreement or other arrangement under which any Third
Party would acquire any rights with respect to any Subject Markers, ACSB shall
give written notice of such Subject Markers to BGM (an “ACSB Marker Notice”),
and shall provide BGM with such additional information regarding such Subject Markers
as BGM shall reasonably request for the purpose of evaluating its interest therein
within five (5) days following delivery of such ACSB Marker Notice. BGM may
exercise its Right of First Offer with respect to such Subject Markers by
giving written notice of exercise to ACSB no later than ten (10) days following
receipt of the applicable ACSB Marker Notice or, if later, five (5) days
following receipt of any additional information requested by BGM in response to
such ACSB Marker Notice as described above. If BGM so exercises its Right of
First Offer with respect to any Subject Markers, the Parties shall negotiate
exclusively and in good faith, for a period of up to thirty (30) days after
such exercise, the terms of a Licensing Addendum that identifies such Subject
Markers as Subject IP; provided, that
no Party shall have any obligation to enter into any such Licensing Addendum. If,
with respect to any

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

11

 

particular
Subject Markers, BGM does not so exercise its Right of First Offer or such a Licensing
Addendum is not entered into within such 30-day period, then ACSB shall be free
to approach Third Parties with respect to such Subject Markers.

 

Section 4.03           No Additional Restrictions. Nothing in this Agreement is intended to preclude
either Party from pursuing business activities outside the scope of this
Agreement. Without limiting the generality of the foregoing, and subject to
compliance with the express terms of this Agreement, nothing in this Agreement
is intended to preclude ACSB from entering into agreements for the discovery,
validation, development and commercialization of novel biomarkers with
biopharmaceutical or diagnostic companies, or to preclude ACSB from
commercializing any Intellectual Property Rights, in either case outside the
scope of this Agreement.

 

ARTICLE V

REPRESENTATIONS AND WARRANTIES/LIABILITIES
AND INDEMNIFICATION

 

Section 5.01           Representations and Warranties of BGM. BGM represents and warrants to ACSB as follows:

 

(a)           Organization and Authority. BGM is a corporation duly organized, validly
existing and in good standing under the laws of the State of Delaware. BGM has
the requisite corporate power and authority to execute and deliver this
Agreement, to perform its obligations hereunder and to consummate the
transactions contemplated hereby. The execution and delivery by BGM of this
Agreement and the performance by BGM of its obligations hereunder have been
duly and validly authorized and BGM has taken all necessary corporate action
with respect thereto. This Agreement has been duly and validly executed and
delivered by BGM and constitutes the legal, valid and binding obligation of
BGM, enforceable against it in accordance with its terms, except as such
enforcement may be limited or affected by applicable bankruptcy, insolvency,
reorganization, moratorium or other similar laws affecting creditors’ rights generally
and by general principles of equity (regardless of whether enforceability is
considered in a proceeding in equity or at law)

 

(b)           No Conflict. Neither the execution, delivery or performance by BGM
of this Agreement nor the consummation by BGM of the transactions contemplated
hereby will (i) conflict with or result in a breach of any provision of the constitutive
documents of BGM or any agreement to which BGM is a party or (ii) violate any
provision of law, or any order, writ, injunction, permit, judgment or decree of
any court or other governmental authority to which BGM is subject or by which its
assets are bound.

 

(c)           Rights to Intellectual Property. BGM has all necessary rights and authority to
grant the licenses and other rights in respect of Intellectual Property set
forth in this Agreement without the need to make any payment to, obtain any
consent from or take any other action with respect to any Third Party.

 

Section 5.02           Representations and Warranties of ACSB. ACSB represents and warrants to BGM as follows:

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

12

 

(a)           Organization and Authority. ACSB will be a corporation duly organized, validly
existing and in good standing under the laws of The Netherlands. ACSB has the
requisite corporate power and corporate authority to execute and deliver this
Agreement, to perform its obligations hereunder and to consummate the
transactions contemplated hereby. The execution and delivery by ACSB of this
Agreement and the performance by ACSB of its obligations hereunder have been
duly and validly authorized and ACSB has taken all necessary corporate action
with respect thereto. This Agreement has been duly and validly executed and
delivered by ACSB and constitutes the legal, valid and binding obligation of ACSB,
enforceable against it in accordance with its terms, except as such enforcement
may be limited or affected by applicable bankruptcy, insolvency,
reorganization, moratorium or other similar laws affecting creditors’ rights
generally and by general principles of equity (regardless of whether enforceability
is considered in a proceeding in equity or at law).

 

(b)           No Conflict. Neither the execution, delivery or performance by
ACSB of this Agreement nor the consummation by ACSB of the transactions
contemplated hereby will (i) conflict with or result in a breach of any
provision of the constitutive documents of ACSB or any agreement to which ACSB
is a party or (ii) violate any provision of law, or any order, writ,
injunction, permit, judgment or decree of any court or other governmental
authority to which ACSB is subject or by which its assets are bound.

 

(c)           Rights to Intellectual Property. ACSB, together with the University and
BioMedbooster, has all necessary rights and authority to grant the licenses and
other rights in respect of Intellectual Property set forth in this Agreement
without the need to make any payment to, obtain any consent from or take any
other action with respect to any Third Party.

 

Section 5.03           NO ADDITIONAL WARRANTIES. EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES SET
FORTH IN THIS ARTICLE V AND ANY REPRESENTATIONS AND WARRANTIES EXPRESSLY SET
FORTH IN A LICENSING ADDENDUM, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE
LAW, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND TO THE
OTHER PARTY, AND EACH PARTY EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, WHETHER
EXPRESS OR IMPLIED AND WHETHER ARISING BY STATUTE, OPERATION OF LAW, COURSE OF
DEALING OR OTHERWISE.  

 

Section 5.04           Limitation of Liability. Under no circumstance shall either Party be liable
to the other Party for any indirect or consequential damages or losses (including,
but not limited to, damages for loss of profit) related to the development and
exploitation of the Subject IP.

 

ARTICLE VI

CONFIDENTIALITY

 

Section 6.01           Access to Confidential Information. Each Party acknowledges that in connection with
the transactions and activities contemplated by this Agreement it may receive or
be exposed to Confidential Information of the other Party.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

13

 

Section 6.02           Obligation to Keep Confidential. Save as expressly provided otherwise in this
Agreement, each Party shall not disclose the Confidential Information of the
other Party to any Third Party and shall keep such Confidential Information
strictly confidential by employing procedures for safeguarding Confidential
Information at least as rigorous as such Party employs for its own Confidential
Information, and in no event less than reasonable procedures. Notwithstanding
the foregoing, each Party shall be entitled to disclose the existence and
contents of this Agreement to (i) such Party’s employees, accountants,
financial advisors, outside counsel and other representatives with a bona fide
need to know (collectively, “Representatives”), and (ii) venture capital
funds, banks and other Persons from whom such Party believes it has a
reasonable likelihood of obtaining debt or equity financing (“Investors”);
provided that, prior to making any such
disclosure, such Party shall inform such Representative or Investor of the
requirements of this Agreement and obtain from such Representative or Investor
his or her agreement to be bound thereby.

 

Section 6.03           Exceptions. The confidentiality obligations under this
Agreement shall not apply to Confidential Information that the receiving Party
can demonstrate by means of dated documentation: (a) was already in the public
domain at the time it was disclosed or subsequently enters the public domain
through no fault of the receiving Party; (b) was known to the receiving Party
or in its possession, as evidenced by dated documentation prior to receipt of
such Confidential Information, (c) was developed by the receiving Party
independently and without use of Confidential Information provided by the
disclosing Party under this Agreement and without any breach of this Agreement
or (d) was lawfully received by the receiving Party on a non-confidential basis
from a Third Party who was not bound by a similar obligation of confidentiality
in relation to the Confidential Information.

 

Section 6.04           Required Disclosure. In the event that, in connection with any legal
proceeding or investigation by a competent court or governmental or
administrative authority, either Party (or any of its representatives) is
required (by oral questions, interrogatories, requests for information or
documents, subpoena, civil investigative demand or similar process) to disclose
any Confidential Information received under this Agreement, such Party shall
provide the other Party with prompt notice of such request(s) so that the other
Party may seek an appropriate protective order or other appropriate remedy. In
the event that such protective order or other remedy is not obtained promptly
or in the event that the other Party grants a waiver hereunder, the Party
concerned may furnish that portion (and only that portion) of the Confidential
Information which, in the written opinion of that Party’s legal counsel, the
Party concerned is legally compelled to disclose and will exercise its best
efforts to obtain an order or other adequate assurance that such Confidential
Information will be treated confidentially. Notwithstanding the foregoing, the
Party may disclose that portion (and only that portion) of the Confidential
Information, which, in the written opinion of its legal counsel, the Party is
legally required to disclose in order to comply with applicable law.

 

Section 6.05           Confidentiality of Agreement; Breach. The Parties acknowledge the confidential nature of
this Agreement and neither Party shall disclose the contents of this Agreement
without obtaining the prior approval of the other Party in writing, save as
required by applicable law or by either Party in connection with the
enforcement of its rights hereunder. Any breach by either Party of any of its
confidentiality obligations under this ARTICLE VI shall not

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

14

 

affect any
right or remedy to which the non-breaching Party would be entitled at law
absent this Agreement.

 

ARTICLE VII

PUBLICATIONS

 

Section 7.01           Authorship. Authorship and other matters relating to
publications arising from activities conducted under this Agreement shall be as
set forth in the Uniform Requirements for Manuscripts Submitted to Biomedical
Journals of the International Committee of Major Journal Editors
(http://www.icmje.org/).

 

Section 7.02           Advance Notice of Publication. Notwithstanding any other provision of this
Agreement to the contrary, ACSB shall, prior to submission for publication of
any manuscript, poster, presentation, abstract or other written or oral
material describing any activities related to this Agreement, provide BGM
thirty (30) days to review any such manuscript and fifteen (15) days to review
any such poster, presentation, abstract or other written or oral material for
the purpose of determining if any patentable information is disclosed thereby. If
BGM requests in writing, ACSB shall withhold any publication or presentation an
additional sixty (60) days solely to permit BGM to seek patent protection and
to remove any confidential or proprietary information from all publications.

 

ARTICLE VIII

TERM AND TERMINATION

 

Section 8.01           Term. This Agreement shall be effective as of the
Effective Date, shall remain in effect through the period ending on the date
five years after the Effective Date (the “Initial Term”), and shall
automatically renew for subsequent one-year periods thereafter (each, a “Renewal
Term”), unless either Party shall give written notice of its intention not
to renew no later than 30 days before the end of the Initial Term or Renewal
Term then in effect.

 

Section 8.02           Termination for Cause. Each Party may terminate this Agreement at any
time by means of a written notice to the other Party in the event that the
other Party fails to perform any material obligation under this Agreement and
such failure (if susceptible to remedy) is not remedied within 30 days after
receipt of a notice specifying the nature of such failure and requiring it to
be remedied (any such termination, a “Termination for Cause”). Such
right of termination shall not be exclusive of any other remedy or means of
redress to which the non-defaulting Party may be lawfully entitled and all such
remedies shall be cumulative.

 

Section 8.03           Bankruptcy Etc. Each Party may terminate this Agreement with
immediate effect by means of a written notice to the other Party in the event
that: (a) a creditor or other claimant takes possession of, or a receiver,
administrator or similar officer is appointed over any of the assets of the
other Party or (b) the other Party makes any voluntary arrangement with its
creditors or becomes subject to any court or administration order pursuant to
any bankruptcy or insolvency law.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

15

 

Section 8.04           Effect of Termination. The obligations of the Parties under this
Agreement and any Licensing Addenda that either expressly or by their nature
would continue beyond the expiration or termination of this Agreement,
(including, without limitation, those concerning payment of a portion of
revenues, confidentiality, warranty and liability as well as obligations to
grant licenses) shall survive expiration or earlier termination of this
Agreement. Without limiting the generality of the foregoing, any licenses to
Subject IP and the rights and the obligations of the Parties under ARTICLE
II, ARTICLE III, ARTICLE V, ARTICLE VI, ARTICLE VII,
ARTICLE VIII and ARTICLE IX, and any similar provisions in any
Licensing Addenda, shall survive expiration or earlier termination of this
Agreement; provided, however, that any exclusive
licenses granted to BGM hereunder shall become non-exclusive if ACSB shall
effect a Termination for Cause.

 

ARTICLE IX

MISCELLANEOUS

 

Section 9.01           Assignment; Binding Effect. Neither this Agreement nor any rights granted
hereunder may be assigned by either Party without the other Party’s prior
written consent, except that (a) either Party may assign this Agreement in its
entirety to any of its Affiliates or to a purchaser of all or substantially all
of its assets or business to which this Agreement principally relates (whether
such transaction is effected by a sale of stock, equity or assets or by merger
or other transaction), and (b) ACSB shall be entitled to assign this Agreement
or any rights granted hereunder to BioMedbooster or the University, to which
assignment BGM hereby consents in advance. Subject to the foregoing, this
Agreement shall be binding upon and inure to the benefit of the parties and
their respective successors and permitted assigns.

 

Section 9.02           No Third Party Beneficiaries. Except for the provisions of Section 3.04
as they relate to the Indemnified Parties and the license grant to the University,
BioMedbooster and their respective Affiliates set forth in Section 2.01(a),
nothing herein expressed or implied is intended to confer upon any Person,
other than the parties hereto and their respective permitted successors and
assigns, any rights, obligations or liabilities under or by reason of this
Agreement.

 

Section 9.03           No Waiver by Conduct; Waiver. The failure of either Party to enforce at any time
any provision of this Agreement shall not be construed as a waiver of such
provision or of the right of such party thereafter to enforce such provision.
Any provision of this Agreement may be waived only by a written instrument
signed by both of the parties hereto.

 

Section 9.04           Governing Law/Jurisdiction. This Agreement shall be governed and construed in
accordance with the laws of The Netherlands, without regard to any conflicts of
law principles thereof. In the event of a dispute regarding the construction or
interpretation of this Agreement the Parties agree that such dispute shall be
exclusively settled by the court competent for the municipality of Maastricht,
The Netherlands; provided, however that ACSB shall
have the right to submit any such dispute to the court competent for the
jurisdiction in which BGM is then located.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

16

 

Section 9.05           Severability. If any provision of this Agreement or the
application thereof to any Person, or to any event or circumstance, is held
invalid or unenforceable to any extent, the remainder of this Agreement and the
application of that provision shall be enforced to the fullest extent permitted
by law.

 

Section 9.06           Counterparts. This Agreement may be executed in counterparts
with the same effect as if the Parties had signed the same document, and such
counterparts, when taken together, shall be construed as and shall constitute
one and the same instrument.

 

Section 9.07           Entire Agreement; Amendment. This Agreement, together with the Licensing
Addenda executed hereunder, constitutes the entire agreement between the Parties
regarding the subject matter hereof, and shall not be amended, altered or
changed except by a written agreement signed by the Parties.

 

Section 9.08           Notices. All notices and other communications given or made
pursuant to this Agreement shall be in writing and shall be deemed effectively
given upon the earlier of actual receipt or: 
(a) personal delivery to the Party to be notified, (b) sending by
confirmed facsimile if sent and confirmed during normal business hours of the
recipient, or, if sent and confirmed during other than normal business hours of
the recipient, then on the next business day after such sending and
confirmation or (c) delivery by an internationally recognized courier during
normal business hours of the recipient, or, if so delivered during other than
normal business hours of the recipient, on the next business day after such
delivery. All communications shall be sent to the respective parties at their
facsimile number or address as set forth below, or to such facsimile number or
address as subsequently modified by written notice given in accordance with
this Section 9.08:

 

	
  BG Medicine, Inc.

  	
  ACS Biomarker B.V.

  
	
  610 N. Lincoln Street

  	
  Oxfordlaan 70

  
	
  Waltham, MA 02451

  	
  6229 EV Maastricht

  
	
  ATTN: President

  	
  ATTN.:

  
	
  facsimile: +1 (781) 895-1119

  	
  facsimile:

  

 

REMAINDER OF PAGE INTENTIONALLY LEFT BLANK

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

17

 

IN WITNESS WHEREOF, the Parties have executed this Product License and
Collaboration Agreement as an instrument under seal as of the date first above
written.

 

	
  BG MEDICINE, INC.

  	
   

  	
  ACS BIOMARKER B.V., i.o.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By its incorporators as listed below:

  
	
  By:

  	
  /s/ Pieter Muntendam

  	
   

  	
   

  
	
    Its President and CEO

  	
   

  	
   

  
	
   

  	
   

  	
  THE UNIVERSITY OF MAASTRICHT

  
	
   

  	
   

  	
   

  
	
  THE UNIVERSITY OF MAASTRICHT

  	
   

  	
   

  
	
  (solely for purposes of Section 3.04)

  	
   

  	
  By:

  	
   /s/ Jo Ritzen

  	
   

  
	
   

  	
   

  	
    Its President

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Jo Ritzen

  	
   

  	
  BIOMEDBOOSTER, B.V.

  
	
    Its President

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  	
  /s/ Tom Melvis

  	
   

  
	
  BIOMEDBOOSTER, B.V. (solely for

  	
   

  	
    Its Attorney

  
	
  purposes of Section 3.04)

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Yigal Pinto

  	
   

  
	
  By:

  	
  /s/ Tom Melvis

  	
   

  	
  Yigal Pinto

  
	
    Its Attorney

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Mat Daemen

  	
   

  
	
   

  	
   

  	
  Mat Daemen

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Tilman Hackeng

  	
   

  
	
   

  	
   

  	
  Tilman Hackeng

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Marcel Kannekens

  	
   

  
	
   

  	
   

  	
  Marcel Kannekens

  	
   

  
							

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

18

 

Exhibit A

 

Licensing Addendum No. 1

 

This Licensing Addendum No. 1 is entered into under and pursuant to the
terms of the Product License and Collaboration Agreement dated as of April    ,
2007 by and between BG Medicine, Inc., a Delaware corporation, and ACS
Biomarker B.V., a corporation organized under the laws of The Netherlands (the “Product
License Agreement”). In the event of any conflict between the Product
License Agreement and the express terms of this Licensing Addendum, the terms
of this Licensing Addendum shall prevail. Capitalized terms used but not
defined in this Licensing Addendum shall have the meanings assigned to them in
the Product License Agreement.

 

1.     Subject IP. The following Intellectual
Property Rights shall constitute Subject IP and therefore be licensed to BGM on
the terms set forth in the Product License Agreement:

 

2.     Exclusivity.

 

3.     Field of Use.

 

4.     Term.

 

5.     Territory.

 

6.     Sublicensing.

 

7.     Field of Interest:  The Field of Interest is hereby expanded to
include:

 

8.     Activities, Rights and Obligations. The
Parties shall undertake the activities, and have the rights and obligations, as
follows:

 

9.     Royalties. The following royalties shall be
payable by BGM to ACSB, in each case on the terms set forth in the Product
License Agreement:

 

10.   Additional Representations and Warranties. The
Parties make the following representations and warranties in addition to those
set forth in the Product License Agreement:

 

11.   Additional Terms. The following additional
terms shall apply:

 

IN WITNESS WHEREOF, the Parties have executed this Licensing Addendum
No.      effective as of this       
day of      ,          .

 

	
  BG MEDICINE, INC.

  	
   

  	
  ACS BIOMARKER B.V.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
    Its

  	
   

  	
    Its

  
						

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

19

 

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

20

 

Licensing Addendum No. 1

 

This Licensing Addendum No. 1 is entered into under and pursuant to the
terms of the Product License and Collaboration Agreement dated as of April    ,
2007 by and between BG Medicine, Inc., a Delaware corporation, ACS Biomarker
B.V. i.o., a corporation to be organized under the laws of The Netherlands and
the other parties thereto (the “Product License Agreement”). In the
event of any conflict between the Product License Agreement and the express
terms of this Licensing Addendum, the terms of this Licensing Addendum shall
prevail. Capitalized terms used but not defined in this Licensing Addendum
shall have the meanings assigned to them in the Product License Agreement.

 

12.   Subject
IP. The following Intellectual Property Rights shall constitute Subject IP
and therefore be licensed to BGM on the terms set forth in the Product License
Agreement and in this Licensing Addendum:

 

a.     all rights of any nature in and to patent
application no. EP 030078161 with a priority date of 9 October 2003, entitled “Method
for identifying a subject at risk of developing heart failure by determining
the level of Galactin-3 or Thrombospondin-2,” and all related patents and
patent applications (including, but not limited to, international application
PCT/EP2004/010879 (pub. no. WO2005/04081) and any and all other foreign
applications, divisional applications, continuations, continuations in part,
revisions, re-examinations and reissues anywhere in the world) that in full or
in part can claim priority of said patent application (“ACSB Pre-Existing IP”).
To the extent ACSB does not possess the right to grant the License described in
this Licensing Addendum as of the date hereof, such License shall become
effective, and shall be deemed granted by ACSB, immediately upon ACSB’s
acquisition of such right.

 

b.     all rights of ACSB in any Intellectual Property
developed by either Party under the Implementation Plan (as defined below), including
without limitation (i) all clinical, drug discovery, research, investigatory,
or other methods, uses or applications and (ii) all Intellectual Property
Rights throughout the world in any of the foregoing, including without
limitation patents, the right to apply for patents and trade secret or
equivalent rights (“Jointly Developed IP”).

 

For the avoidance of doubt, all rights of BGM in any Jointly Developed
IP shall remain the sole and exclusive property of BGM, and ACSB shall not have
any license or other rights thereto.

 

13.   Exclusivity.
The License granted under this Licensing Addendum shall be exclusive, even as
to ACSB; provided, however, that in the event BGM
breaches any material term of the Implementation Plan, which breach is not
cured within 30 days following written notice thereof by ACSB to BGM, such
License shall become non-exclusive and provided further,
that ACSB, BioMedbooster, the University and their respective Affiliates shall
have the limited license to the ACSB Pre-Existing IP and Jointly Developed IP
set forth in Section 2.01(a) of the Product License Agreement.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

21

 

14.   Field of Use. The License granted under this
Licensing Addendum shall permit BGM to use and exploit the ACSB Pre-Existing IP
and Jointly Developed IP for any purpose whatsoever.

 

15.   Term. The License granted under this
Licensing Addendum shall be perpetual.

 

16.   Sublicensing. The License granted under this
Licensing Addendum shall include the right to grant sublicenses to any of the
rights of BGM.

 

17.   Territory. The License granted under this
Licensing Addendum shall be valid worldwide.

 

18.   Field of Interest:  The Field of Interest shall include the field
of congestive heart failure.

 

19.   Activities, Rights and Obligations. The
Parties shall undertake the activities, and have the rights and obligations, as
follows:

 

a.     BGM and ACSB shall collaborate in good faith to
develop a roadmap and implementation plan for development and commercialization
of the ACSB Pre-Existing IP (the “Implementation Plan”), and further
agree that:

 

i.      BGM shall use commercially
reasonable efforts to realize commencement of commercial distribution of
Subject Products based on ACSB Pre-Existing IP to the extent provided in the
Implementation Plan, and shall inform ACSB at least once every calendar quarter
about progress under the Implementation Plan.

 

ii.     ACSB shall provide such assistance in regard to
the ACSB Pre-Existing IP and the activities described in the Implementation
Plan as BGM shall reasonably request; provided,
however, that ACSB shall not be obligated to provide more than [***] man hours
of such assistance in any twelve-month period unless BGM shall agree to
compensate ACSB therefor at a reasonable commercial rate to be negotiated in
good faith by the Parties.

 

iii.    BGM shall reimburse ACSB for any out of pocket
expenses reasonably incurred by ACSB in connection with the provision of such
assistance.

 

b.     The Parties shall establish a scientific advisory
board to provide input and guidance with respect to activities under the
Implementation Plan.

 

20.   Royalties. The following royalties shall be
payable by BGM to ACSB, in each case on the terms set forth in the Product
License Agreement:

 

a.     a royalty equal to [***]% of Net Sales from
Subject Products in the Field of Interest described in paragraph 7 of this
Licensing Addendum that are developed solely using ACSB Pre-Existing IP.

 

b.     a royalty equal to [***]% of Net Sales from
Subject Products within the Field of Interest described in paragraph 7 of this
Licensing Addendum that are developed

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

22

 

using any Jointly Developed IP (including without limitation Subject
Products developed using Jointly Developed IP and ACSB Pre-Existing IP).

 

c.     a royalty equal to [***]% of Sublicensing Income
from Subject Products in the Field of Interest described in paragraph 7 of this
Licensing Addendum that are developed solely using ACSB Pre-Existing IP.

 

d.     a royalty equal to [***]% of Sublicensing Income
from Subject Products within the Field of Interest described in paragraph 7 of this
Licensing Addendum that are developed using any Jointly Developed IP (including
without limitation Subject Products developed using Jointly Developed IP and
ACSB Pre-Existing IP).

 

21.   Milestone Payments. BGM will make the
following milestone payments to ACSB:

 

a.     $[***] payable within [***] days of the later to
occur of (i) formation of ACSB and (ii) the transfer or exclusive license of
rights to ACSB by the University, BioMedbooster and any other applicable Third
Parties described in paragraph 13.a. below. BGM’s obligation to make such
payment shall be conditioned upon the delivery to BGM of (A) documentation of
such formation and transfer or licensing in form and substance reasonably
satisfactory to BGM and (B) a document in form and substance reasonably
satisfactory to BGM and signed by ACSB ratifying the Product License Agreement,
this Licensing Addendum and any other Licensing Addenda then existing and
acknowledging its obligations and status as a party hereunder and thereunder.

 

b.     $[***] payable within [***] days after the first
of the following events to occur:

 

i.  the acquisition by BGM of sufficient aliquots of
plasma samples and data from the PRIDE study conducted at the Massachusetts
General Hospital, Boston, MA and published in Am J Cardiol 2005;95:948–954,
with authorization for use and of sufficient quality for use as a pivotal
regulatory study in conjunction with additional BGM studies, or

 

ii. the initiation by BGM using ACSB Pre-Existing IP or
Jointly Developed IP of full development of thrombospondin-2, with “full
development” meaning the start of assay development and a clinical
qualification study of thrombospondin in congestive heart failure as required
for US regulatory submission.

 

22.   Royalty Prepayment. BGM will make the royalty
prepayment to ACSB described below. Such prepayment shall be credited against
any royalties otherwise payable under this Licensing Addendum or any other
Licensing Addendum, but ACSB shall not be required to refund such prepayment. In
the event that BGM pays royalties to ACSB under this or under any other
Licensing Addendum, the amount of prepayment shall be reduced by the amount of
royalties so paid.

 

a.     $[***] upon the occurrence of the first of the
following events:

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

23

 

i.  Regulatory Approval for the US of a Subject Product
within the Field of Interest described in paragraph 7 of this Licensing
Addendum that has been developed using any Jointly Developed IP or ACSB
Pre-Existing IP; or

 

ii. The issuance of a US or EU patent covering a Subject
Product within the Field of Interest described in paragraph 7 of this Licensing
Addendum that has been developed using any Jointly Developed IP or ACSB
Pre-Existing IP.

 

23.   Additional Representations and Warranties. The
Parties make the following representations and warranties in addition to those
set forth in the Product License Agreement:

 

a.     ACSB represents and warrants to BGM that, upon the
transfer or exclusive license to ACSB of rights by the University,
BioMedbooster and any other applicable Third Parties described in paragraph
13.a. below, it will be the exclusive owner or exclusive licensee of all right,
title and interest in the ACSB Pre-Existing IP, with full right, power and
authority to grant the License granted to BGM under this Licensing Addendum.

 

24.   Additional Terms. The following additional
terms shall apply:

 

a.     ACSB shall use its best efforts to cause all
Intellectual Property Rights of the University, BioMedbooster and any other
Third Parties in the ACSB Pre-Existing IP to be transferred or exclusively
licensed to ACSB as soon as possible after the execution of this Licensing
Addendum.

 

b.     BGM shall reimburse patent prosecution costs
previously incurred by ACSB in connection with the ACSB Pre-Existing IP upon
presentation to BGM of appropriate documentation, up to a maximum of $[***].

 

c.     Each Party shall give the other Party prompt
notice of the development of any Jointly Developed IP.

 

REMAINDER OF PAGE INTENTIONALLY LEFT BLANK

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

24

 

IN WITNESS WHEREOF, the Parties have executed this Licensing Addendum
No. 1 effective as of this      day of April, 2007.

 

	
  BG MEDICINE, INC.

  	
   

  	
  ACS BIOMARKER B.V., i.o.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Pieter Muntendam

  	
   

  	
  By its incorporators as listed below:

  
	
  Its President and CEO

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  THE UNIVERSITY OF MAASTRICHT

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  	
  /s/ Jo Ritzen

  	
   

  
	
   

  	
   

  	
    Its President

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  BIOMEDBOOSTER, B.V.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  	
  /s/ Tom Melvis

  	
   

  
	
   

  	
   

  	
    Its Attorney

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Yigal Pinto

  	
   

  
	
   

  	
   

  	
   

  	
  Yigal Pinto

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Mat Daemen

  	
   

  
	
   

  	
   

  	
  Mat Daemen

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Tilman Hackeng

  	
   

  
	
   

  	
   

  	
  Tilman Hackeng

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Marcel Kannekens

  	
   

  
	
   

  	
   

  	
  Marcel Kannekens

  	
   

  
							

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

 

Licensing Addendum No. 2

 

This Licensing Addendum No. 2 is entered into under and pursuant to the
terms of the Product License and Collaboration Agreement dated as of April     ,
2007 by and between BG Medicine, Inc., a Delaware corporation, ACS Biomarker
B.V. i.o., a corporation to be organized under the laws of The Netherlands and
the other parties thereto (the “Product License Agreement”). In the
event of any conflict between the Product License Agreement and the express
terms of this Licensing Addendum, the terms of this Licensing Addendum shall
prevail. Capitalized terms used but not defined in this Licensing Addendum
shall have the meanings assigned to them in the Product License Agreement.

 

25.   Subject IP. The following Intellectual
Property Rights shall constitute Subject IP and therefore be licensed to BGM on
the terms set forth in the Product License Agreement and in this Licensing
Addendum:

 

a.     all rights of any nature in and to patent
application no. EP 06009314.3
with a priority date of May 5, 2006, entitled “peptides for use in diagnosing
the presence of ruptured atherosclerotic lesions in an individual” and all
related patents and patent applications (including, but not limited to,
international application PCT/EP 2006.949 EP/PD (pub. no.) and any and all
other foreign applications, divisional applications, continuations,
continuations in part, revisions, re-examinations and reissues anywhere in the
world) that in full or in part
can claim priority of said patent application  (“ACSB
Pre-Existing IP”). To the extent ACSB does not possess the right to grant
the License described in this Licensing Addendum as of the date hereof, such
License shall become effective, and shall be deemed granted by ACSB,
immediately upon ACSB’s acquisition of such right.

 

b.     all rights of ACSB in any Intellectual Property
developed by either Party under the Implementation Plan (as defined below),
including without limitation (i) all clinical, drug discovery, research,
investigatory, or other methods, uses or applications and (ii) all Intellectual
Property Rights throughout the world in any of the foregoing, including without
limitation patents, the right to apply for patents and trade secret or
equivalent rights (“Jointly Developed IP”).

 

For the avoidance of doubt, all rights of BGM in any Jointly Developed
IP shall remain the sole and exclusive property of BGM, and ACSB shall not have
any license or other rights thereto.

 

26.   Exclusivity. The License granted under this
Licensing Addendum shall be exclusive, even as to ACSB; provided,
however, that in the event BGM breaches any material term of the Implementation
Plan, which breach is not cured within 30 days following written notice thereof
by ACSB to BGM, such License shall become non-exclusive and provided further, that ACSB, BioMedbooster, the University
and their respective Affiliates shall have the limited license to the ACSB
Pre-Existing IP and Jointly Developed IP set forth in Section 2.01(a) of the
Product License Agreement.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

26

 

27.   Field of Use. The License granted under this
Licensing Addendum shall permit BGM to use and exploit the ACSB Pre-Existing IP
and Jointly Developed IP for any purpose whatsoever.

 

28.   Term. The License granted under this
Licensing Addendum shall be perpetual.

 

29.   Sublicensing. The License granted under this
Licensing Addendum shall include the right to grant sublicenses to any of the
rights of BGM.

 

30.   Territory. The License granted under this
Licensing Addendum shall be valid worldwide.

 

31.   Field of Interest:  The Field of Interest shall include the field
of atherothrombotic vascular disease, including non-ischemia angina.

 

32.   Activities, Rights and Obligations. The
Parties shall undertake the activities, and have the rights and obligations, as
follows:

 

a.     BGM and ACSB shall collaborate in good faith to
develop a roadmap and implementation plan for development and commercialization
of the ACSB Pre-Existing IP (the “Implementation Plan”), and further
agree that:

 

i.      BGM shall use commercially reasonable efforts to
realize commencement of commercial distribution of Subject Products based on
ACSB Pre-Existing IP to the extent provided in the Implementation Plan, and
shall inform ACSB at least once every calendar quarter about progress under the
Implementation Plan.

 

ii.     ACSB shall provide such assistance in regard to
the ACSB Pre-Existing IP and the activities described in the Implementation
Plan as BGM shall reasonably request; provided,
however, that ACSB shall not be obligated to provide more than 100 man hours of
such assistance in any twelve-month period unless BGM shall agree to compensate
ACSB therefor at a reasonable commercial rate to be negotiated in good faith by
the Parties.

 

iii.    BGM shall reimburse ACSB for any out of pocket
expenses reasonably incurred by ACSB in connection with the provision of such
assistance.

 

b.     The Parties shall establish a scientific advisory
board to provide input and guidance with respect to activities under the
Implementation Plan.

 

33.   Royalties. The following royalties shall be
payable by BGM to ACSB, in each case on the terms set forth in the Product
License Agreement:

 

a.     a royalty equal to [***]% of Net Sales from
Subject Products in the Field of Interest described in paragraph 7 of this
Licensing Addendum that are developed solely using ACSB Pre-Existing IP.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

27

 

b.     a royalty equal to [***]% of Sublicensing Income
from Subject Products in the Field of Interest described in paragraph 7 of this
Licensing Addendum that are developed solely using ACSB Pre-Existing IP.

 

34.   Milestone Payments. BGM will make the
following milestone payments to ACSB:

 

a.     $[***] payable within [***] days of the last to
occur of (i) the formation of ACSB, (ii) the transfer or exclusive license of
rights to ACSB by the University and BioMedbooster described in paragraph 13.a.
below and (iii) the termination of all other rights of Third Parties in and to
the ACSB Pre-Existing IP. BGM’s obligation to make such payment shall be
conditioned upon the delivery to BGM of (A) documentation of such formation,
transfer or licensing and termination in form and substance reasonably
satisfactory to BGM and (B) a document in form and substance reasonably
satisfactory to BGM and signed by ACSB ratifying the Product License Agreement,
this Licensing Addendum and any other Licensing Addenda then existing and
acknowledging its obligations and status as a party hereunder and thereunder.

 

35.   Royalty Prepayment. BGM will make the royalty
prepayment to ACSB described below. Such prepayment shall be credited against
any royalties otherwise payable under this Licensing Addendum or any other
Licensing Addendum, but ACSB shall not be required to refund such prepayment. In
the event that BGM pays royalties to ACSB under this or under any other
Licensing Addendum, the amount of prepayment shall be reduced by the amount of
royalties so paid.

 

a.     $250,000 upon the occurrence of the first of the
following events:

 

i.  Regulatory Approval for the US of a Subject Product
within the Field of Interest described in paragraph 7 of this Licensing
Addendum that has been developed using any Jointly Developed IP or ACSB
Pre-Existing IP; or

 

ii. The issuance of a US or EU patent covering a Subject
Product within the Field of Interest described in paragraph 7 of this Licensing
Addendum that has been developed using any Jointly Developed IP or ACSB
Pre-Existing IP.

 

36.   Additional Representations and Warranties. The
Parties make the following representations and warranties in addition to those
set forth in the Product License Agreement:

 

a.     ACSB represents and warrants to BGM that, upon the
transfer or exclusive license to ACSB of all rights of the University and
BioMedbooster in and to the ACSB Pre-Existing IP and the termination of any
rights of [***] or its Affiliates in and to the ACSB Pre-Existing IP, it will
be the exclusive owner or exclusive licensee of all right, title and interest
in the ACSB Pre-Existing IP, with full right, power and authority to grant the
License granted to BGM under this Licensing Addendum.

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

28

 

37.   Additional Terms. The following additional
terms shall apply:

 

a.     The rights and obligations of BGM and ACSB under
this Licensing Addendum are subject to the condition precedent that ACSB
acquire all of the ACSB Pre-Existing IP. BGM acknowledges that (i) some or all
of the ACSB Pre-Existing IP is currently owned by one or more Third Parties and
(ii) ACSB does not warrant in any way that this condition precedent will be
fulfilled.

 

b.     In the event the condition precedent set forth in
paragraph 13 a. above is not fulfilled within two years after the date of this
Licensing Addendum,  this Licensing
Addendum shall automatically terminate and the Parties will not have any
obligations hereunder whatsoever. In the event ACSB acquires the ACSB
Pre-Existing IP after such a termination, this Licensing Addendum shall impose
no restriction on the ability of ACSB to enter into any transaction with any
third party related to the ACSB Pre-Existing IP.

 

c.     BGM shall reimburse patent prosecution costs
previously incurred by ACSB in connection with the ACSB Pre-Existing IP upon
presentation to BGM of appropriate documentation, up to a maximum of $[***].

 

d.     Each Party shall give the other Party prompt
notice of the development of any Jointly Developed IP.

 

REMAINDER OF PAGE INTENTIONALLY LEFT BLANK

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.

 

29

 

IN WITNESS WHEREOF, the Parties have executed this Licensing Addendum
No. 2 effective as of this          day
of April, 2007.

 

	
  BG MEDICINE, INC.

  	
   

  	
  ACS BIOMARKER B.V., i.o.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Pieter Muntendam

  	
   

  	
  By its incorporators as listed below:

  
	
  Its President and CEO

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  THE UNIVERSITY OF MAASTRICHT

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  	
  /s/ Jo Ritzen

  	
   

  
	
   

  	
   

  	
    Its President

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  BIOMEDBOOSTER, B.V.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  	
  /s/ Tom Melvis

  	
   

  
	
   

  	
   

  	
    Its Attorney

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Yigal Pinto

  	
   

  
	
   

  	
   

  	
   

  	
  Yigal Pinto

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Mat Daemen

  	
   

  
	
   

  	
   

  	
  Mat Daemen

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Tilman Hackeng

  	
   

  
	
   

  	
   

  	
  Tilman Hackeng

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  /s/ Marcel Kannekens

  	
   

  
	
   

  	
   

  	
  Marcel Kannekens

  	
   

  
							

 

Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 406 of the
Securities Act.Exhibit 10.13

 

STRATEGIC AGREEMENT

 

This Strategic Agreement (“Agreement”) is made and entered into effective as of the 25 day
of May, 2007 (“Effective Date”) by and between
HUMANA INC. (“Humana”), a Delaware corporation,
and BG MEDICINE, INC. (“BGM”), a Delaware
corporation. Humana and BGM may be individually referred to herein to as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, BGM, from time to time, engages in
studies to discover and develop blood-based biomarker tests and products for
clinical application to improve patient outcomes.

 

WHEREAS, BGM desires to engage Humana, and
Humana wishes, to provide to BGM certain services regarding such studies;

 

WHEREAS, the Parties desire to agree on
certain terms and conditions to govern their business relationship for the term
specified herein in connection with such services.

 

WHEREAS, the Parties desire to work together
to support the appropriate use of blood-based biomarkers for the benefit of
patients,

 

NOW, THEREFORE, in consideration of the
mutual promises, covenants, and agreements contained in this Agreement,
intending to be legally bound, the Parties agree as follows:

 

ARTICLE 1

DEFINITIONS

 

Unless otherwise specifically provided
herein, the following terms shall have the following meanings:

 

1.1                               “Affiliate” shall mean, with respect to a Party, any Person
that, directly or indirectly, through one or more intermediaries, controls, is
controlled by, or is under common control with, such Party. For purposes of
this definition, “control” and, with correlative meanings, the terms “controlled
by” and “under common control with” shall mean (a) the possession, directly or
indirectly, of the power to direct the management or policies of a business
entity, whether through the ownership of voting securities, by contract
relating to voting rights or corporate governance, or otherwise, or (b) the
ownership, directly or indirectly, of at least fifty percent (50%) of the
voting securities or other ownership interest of a business entity (or, with
respect to a limited partnership or other similar entity, its general partner
or controlling entity).

 

1.2                               “Agreement” shall have the meaning set forth in the preamble
to this Agreement.

 

1.3                               “Applicable Law” shall mean applicable laws, rules and
regulations, including any rules, regulations, guidelines or other requirements
of the Regulatory Authorities, that may be in effect from time to time.

 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

 

1.4                               “BGM” shall have the meaning set forth in the preamble to
this Agreement.

 

1.5                               “BGM Commercialized Diagnostic Product” shall have the
meaning set forth in Section 5.1.1.

 

1.6                               “Breaching Party” shall have the meaning set forth in Section
10.2.

 

1.7                               “Business Day” shall mean a day other than a Saturday or
Sunday on which banking institutions in the state of Delaware are open for
business.

 

1.8                               “Calendar Quarter” shall mean each successive period of three
(3) calendar months commencing on January 1, April 1, July 1 and October 1,
except that the first Calendar Quarter of the Term shall commence on the
Effective Date and end on the day immediately prior to the first to occur of
January 1, April 1, July 1 or October 1 after the Effective Date, and the last
Calendar Quarter shall end on the last day of the Term.

 

1.9                               “Complaining Party” shall have the meaning set forth in
Section 10.2.

 

1.10                        “Confidential Information” shall mean any and all information
or material, whether oral, visual, in writing or in any other form, that, at
any time before or after the Effective Date, has been or is provided,
communicated or otherwise made known to the receiving Party by or on behalf of
the disclosing Party pursuant to this Agreement or in connection with the
transactions contemplated hereby or any discussions or negotiations with
respect thereto, including the terms of this Agreement. Confidential
Information shall not include any information that:

 

(a)                                  is
now, or hereafter becomes, generally available to the public through no
wrongful act, fault or negligence on the part of the receiving Party (or its
employees, agents or contractors);

 

(b)                                 was
already in the possession of the receiving Party without restriction as to
confidentiality at the time of disclosure as evidenced by competent written
records;

 

(c)                                  is
subsequently received by the receiving Party from a Third Party who is not
bound by any obligation of confidentiality with respect to said information;

 

(d)                                 has
been published by a Third Party or otherwise enters the public domain through
no fault of the receiving Party in breach of this Agreement; or

 

(e)                                  was
independently developed by or for the receiving Party without reference to the
disclosing Party’s Confidential Information as evidenced by competent written
records.

 

Specific aspects or details of Confidential
Information shall not be deemed to be within the public domain or in the
possession of the receiving Party merely because the Confidential Information
is embraced by more general information in the public domain or in the
possession of the receiving Party. Further, any combination of Confidential
Information shall not be considered in the public domain or in the possession
of the receiving Party merely because

 

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

2

 

individual elements of such Confidential Information
are in the public domain or in the possession of the receiving Party unless the
combination and its principles are in the public domain or in the possession of
the receiving Party.

 

1.11                        “Conflicts Committee” shall have the meaning set forth in
Section 2.2.

 

1.12                        “Conflict of Interest” shall mean a financial or
associational interest that has the potential, or the appearance of having the
potential, to compromise the independent judgment of the Person who holds the
interest.

 

1.13                        “Consideration”
shall mean the consideration to which Humana is entitled pursuant to Article 5
of the Agreement.

 

1.14                        “Covered Project” shall have the meaning set forth in Section
3.1.1.

 

1.15                        “Diagnostic Product” shall have the meaning set forth in
Section 3.1.1.

 

1.16                        “Effective Date” shall mean the effective date of this
Agreement as set forth in the preamble to this Agreement.

 

1.17                        “Exclusivity
Term” shall have the meaning set forth in Section 3.1.1.

 

1.18                        “FFDCA” shall mean the United States Federal Food, Drug, and
Cosmetic Act, as amended from time to time.

 

1.19                        “Health
Benefit Population”  shall mean the
Persons for whom health care benefits are covered or administered by particular
health maintenance organizations, insurance carriers, health benefit
administrators, pharmacy benefit managers, disease management companies or
their Affiliates.

 

1.20                        “Humana” shall have the meaning set forth in the preamble to
this Agreement.

 

1.21                        “Humana
Members” shall mean Persons for whom Humana or any of its Affiliates bears
financial risk for health care costs or for whom any of them administers health
benefit contracts.

 

1.22                        “Indemnitee” shall have the meaning set forth in Section 9.3.

 

1.23                        “Initial Term” shall have the meaning set forth in Section
10.1.

 

1.24                        “Joint Steering Committee” and “JSC”
shall have the meaning set forth in Section 4.1.1.

 

1.25                        “Knowledge” shall mean the actual knowledge or good faith
understanding of the managing directors, vice presidents, senior vice
presidents, president or chief executive officer of a Party of the facts and
information then in their possession following commercially reasonable due
inquiry.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

3

 

1.26                        “Losses” shall have the meaning set forth in Section 9.1.

 

1.27                        “Master
Research Agreement” shall have the meaning set forth in Section 3.2.

 

1.28                        “MFN Price” shall mean, with respect to a sale of a BGM
Commercialized Diagnostic Product in a particular country, the lowest price
available from BGM to [***], or [***], excluding in the case of sales
[***]:  (a) any prices charged to the
[***], and [***]; (b) any prices charged [***]; and (c) [***] and [***].

 

1.29                        “Net Sales” shall mean, with respect to a
particular BGM Commercialized Diagnostic Product, the actual gross amount
invoiced by BGM or its Affiliates for commercial sales of such product after
deducting, in accordance with GAAP, the following:

 

(i)                                     trade, cash and quantity discounts reasonably
consistent with industry standards;

 

(ii)                                  credits or allowances for damaged or spoiled
product, returns, recalls or rejections of products, including allowance for
breakage or spoilage;

 

(iii)                               sales, value added, excise or other direct
taxes, and freight, postage, shipping and transportation insurance charges and
additional transportation, custom duties, and other governmental charges on the
BGM Commercialized Diagnostic Product; and

 

(iv)                              chargebacks, rebates or similar payments or
credits directly related to the BGM Commercialized Diagnostic Product
consistent with reasonable industry standards granted to managed health care
organizations, wholesalers, distributors, buying groups, retailers, Health
Benefits Population, or other institutions or health care organizations or to federal,
state/provincial, local and other governments, their agencies and purchasers
and reimbursers.

 

Sales or other transfers
between BGM and its Affiliates shall be excluded from the computation of Net
Sales and no payments will be payable on such sales or transfers except where
such Affiliates are end users, but Net Sales shall include the subsequent sales
to Third Parties by such Affiliates. Where an Affiliate is the end user, Net
Sales shall be deemed to be equal to the average per-unit price charged to
Third Parties for the same BGM Commercialized Diagnostic Product during the
relevant calendar half-year multiplied by the number of units sold or
transferred to the Affiliate during such calendar half-year.

 

1.30                        “Non-Humana
Transaction” shall have the meaning set forth in Section 5.2.1.

 

1.31                        “Notice Period” shall have the meaning set forth in Section
10.2.

 

1.32                        “Party” and “Parties” shall
have the meaning set forth in the preamble to this Agreement.

 

1.33                        “Person” shall mean an individual, sole proprietorship,
partnership, limited partnership, limited liability partnership, corporation,
limited liability company, business trust, joint stock company, trust,
unincorporated association, joint venture or other similar entity or

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

4

 

organization, including a government or political
subdivision, department or agency of a government.

 

1.34                        “Plaque
Agreement” shall have the meaning in Section 11.6.2.

 

1.35                        “Product
Line Successors” shall have the meaning set forth in Section 11.8.2.

 

1.36                        “Regulatory Authority” shall mean any supra-national,
federal, national, regional, state, provincial or local regulatory agencies,
departments, bureaus, commissions, councils or other government entities
regulating or otherwise exercising authority with respect to the performance of
the Services.

 

1.37                        “Renewal Term” shall have the meaning set forth in Section
10.1.

 

1.38                        “Research Collaboration Agreement” shall have the meaning set
forth in Section 3.3.

 

1.39                        “[***]
Statement” shall have the meaning set forth in Section 5.2.4.

 

1.40                        “Services” shall have the meaning set forth in Section 3.3.

 

1.41                        “Term” shall have the meaning set forth in Section 10.1.

 

1.42                        “Third Party” shall mean any Person other than BGM, Humana
and their respective Affiliates.

 

1.43                        “Third Party Claims” shall have the meaning set forth in
Section 9.1.

 

1.44                        “Valid
Claim” shall mean a claim of an issued and unexpired patent, which has not
been revoked or held unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, and which has not been
disclaimed or surrendered through reissue or disclaimer.

 

ARTICLE 2

SCOPE AND PURPOSE

 

2.1                               Purpose
– Discovery and Development. Blood-based biomarkers have the potential to
significantly enhance the diagnosis and treatment of a variety of medical
conditions by enabling physicians to select the best treatment regimen for
their patients. The Parties are committed to accelerating the development of
blood-based biomarkers by collaborating on Covered Projects. The development and
validation of such biomarkers requires that research be conducted involving
large numbers of human subjects, which Humana is uniquely poised to facilitate.
The Parties therefore wish to enter into this Agreement to establish an
arrangement to cooperate on Covered Projects and to exchange Consideration from
the discovery and development of effective biomarkers.

 

2.2                               Purpose
– Appropriate Use. The Parties are committed to collaborating on studying
the role of specific blood-based biomarkers in improving treatment outcomes and
to

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

5

 

understanding the promotion of appropriate use of
specific biomarkers through various means, including but not limited to patient
and provider education and information, care management, or benefit design
considerations.

 

2.3                               Conflicts
of Interest. The Parties agree and acknowledge that a potential Conflict of
Interest may develop as a result of Humana’s agreement to engage in a Covered
Project pursuant to a Research Collaboration Agreement or any other research
project involving BGM while at the same time receiving or being eligible to
receive the Consideration. The Parties are committed to the safety and
well-being of participating human subjects, to preserving the integrity of data
generated and collected, and maintaining the confidence of the public in the
bona fides of any Covered Project or other research collaboration. Accordingly,
Humana will arrange for this Agreement, the Master Research Agreement, each
Research Collaboration Agreement, the Plaque Agreement, and any other agreement
involving both Parties to be reviewed by a committee specially constituted to
review potential Conflicts of Interest and direct and oversee the
implementation of Conflict of Interest management steps (the “Conflicts Committee”). The Parties agree to amend this
Agreement or take any other actions determined by the Conflicts Committee to be
necessary to manage a potential Conflict of Interest. If the Conflicts
Committee at anytime determines that the Parties cannot simultaneously enter into
the contemplated arrangements, or if the Parties are unwilling or unable to
implement the directives of the Conflicts Committee, including, but not limited
to, amending this Agreement and the Consideration set forth, the Conflicts
Committee will direct that one or more of the contemplated arrangements be
terminated, if already in effect, or aborted, if in negotiations. In the event
that the Conflicts Committee directs that one or more of the contemplated
arrangements be terminated, they shall thereupon be deemed terminated.

 

ARTICLE 3

RESEARCH COLLABORATION AGREEMENTS

 

3.1                               Exclusive
Period for Covered Projects

 

3.1.1                     During
the 12 month period commencing upon the Effective Date (the “Exclusivity Term”), Humana shall not enter into any
agreement with any Third Party to engage in a project or study involving the
[***] test or product (each such test or product, a “Diagnostic
Product”) or involving [***] , that involves [***] a particular
Health Benefit Population (each, a “Covered Project”).

 

3.1.2                     The Exclusivity
Term shall be automatically renewed during the Term of the Agreement for
subsequent periods of 12 months each unless either party, at least 90 days
prior to the expiration of any Exclusivity Term, provides written notice of
non-renewal to the other party, in which case, upon expiration of the
then-current Exclusivity Term, Humana shall have no further obligation to BGM
pursuant to this Section 3.1.

 

3.2                               Master
Research Agreement. The Parties shall enter into an agreement governing
ownership of data, rights to inventions, and other intellectual property issues
relating to Covered Projects, compensation, and other terms and conditions for
Covered Projects (the “Master Research Agreement”).
Humana and BGM shall negotiate with each other in good

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

6

 

faith regarding the terms of the Master Research
Agreement. The Research Collaboration Agreements governing specific Covered
Projects shall be subject to the Master Research Agreement.

 

3.3                               Research
Collaboration Agreements. From time to time during the Term, the Parties
may agree to engage in research or development services (the “Services”) in connection with one or more Covered Projects
under this Agreement by executing and delivering one or more research
collaboration agreements (each a “Research Collaboration
Agreement”) which shall be negotiated and agreed to between the
parties and which shall each be subject to the Master Research Agreement unless
otherwise expressly specified in the Research Collaboration Agreement.

 

3.4                               Performance.
Each Party shall at all times conduct its operations in compliance with
Applicable Law, including all fraud and abuse, anti-kickback, human subject
protection, and patient confidentiality laws and regulations, and the Parties
shall immediately cease all activities in connection with any part of this
Agreement (or any Research Collaboration Agreement) that are prohibited, or
become prohibited, by Applicable Law.

 

ARTICLE 4

MANAGEMENT

 

4.1                               Joint
Steering Committee.

 

4.1.1                     Within
thirty (30) days after the Effective Date, the Parties shall form a joint
steering committee (the “Joint Steering Committee”
or “JSC”) to review all Services being
conducted hereunder and to discuss potential Research Collaboration Agreements
and the proposed terms thereof. Each Party shall designate its initial members
of the JSC within thirty (30) days after the Effective Date by written notice
to the other Party.

 

4.2                               Limitations
on Authority. Each Party shall retain the rights, powers and discretion
granted to it under this Agreement and no such rights, powers, or discretion
shall be delegated to or vested in the JSC unless such delegation or vesting of
rights is expressly provided for in this Agreement or the Parties expressly so
agree in writing. The JSC shall not have the power to amend, modify or waive
compliance with this Agreement, which may only be amended or modified as
provided in Section 11.7 or compliance with which may only be waived as
provided in Section 11.8.

 

ARTICLE 5

CONSIDERATION

 

5.1                               Diagnostic
Products Sold by BGM for Humana Members.

 

5.1.1                     Subject
to Sections 5.3 and 5.4, with respect to any Diagnostic Product that (a) is
materially derived from any data developed by Humana in performance of a
Covered Project or embodies any invention, development, discovery, evaluation,
or validation by BGM

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

7

 

arising out of data or other services provided by
Humana pursuant to a Covered Project and (b) is sold by BGM or any of its
Affiliates (each such product, a “BGM Commercialized
Diagnostic Product”), Humana shall receive from BGM the benefit of
the MFN Price in effect as of the date such BGM Commercialized Diagnostic
Product(s) are sold by BGM or any of its Affiliates to or for the use of Humana
Members [***], calculated in accordance with Section 5.1.2  For clarity, BGM shall have [***] to offer
Humana [***] terms with respect to BGM Commercialized Diagnostic Product that
[***] BGM as of the [***].

 

5.1.2                     With
respect to sales in the United States, the initial MFN Price for a BGM
Commercialized Diagnostic Product shall be calculated on a [***] basis, based
on [***] in the most recent [***] that ended at least [***] days prior to the
date of such determination. Thereafter, the MFN Price shall be determined by
BGM within [***] days after the end of each [***], shall take effect on the
[***] day of the [***] month after the end of such [***] and shall remain in
effect for [***] months thereafter. By way of example, and without limitation
to the foregoing, if BGM calculates the MFN Price for a BGM Commercialized
Diagnostic Product for [***]BGM would notify Humana thereof by [***] and such
MFN Price would take effect on [***] and would remain in effect until [***]. For
the [***] ending [***], BGM would then recalculate the MFN Price for such BGM
Commercialized Diagnostic Product, and notify Humana thereof by [***] and such
MFN Price would take effect on [***] and would remain in effect until [***].

 

5.1.3                     Notwithstanding
Section 5.1.2, when the first BGM Commercialized Diagnostic Product has been
licensed for sale in [***] other than [***], the parties shall enter into a
supplemental agreement providing details similar to those in Section 5.1.2
regarding [***]the MFN Price for sales in [***] and also providing appropriate
exclusions, similar to those contained in Sections 1.28 and 5.4, from MFN Price
obligations based on applicable laws of [***].

 

5.1.4                     The
Parties may, as they deem appropriate, enter into other supplemental agreements
that provide greater details regarding how the MFN Price [***], and how Humana
is to [***] the MFN Price, with respect to particular BGM Commercialized
Diagnostic Products considering the [***] of [***], their [***], and other
relevant factors.

 

5.1.5                     BGM’s
obligations under this Section 5.1 shall apply to all BGM Commercialized
Diagnostic Products that were [***] or [***] during the term [***], and for
each such product such obligations shall continue until the [***] such product, [***] the term [***] has [***].

 

5.2                               Diagnostic
Products Sold by BGM to Persons other than Humana Members.

 

5.2.1                     With
respect to any BGM Commercialized Diagnostic Product that is sold by BGM or any
of its Affiliates for the use of a Person other than a Humana Member (a “Non-Humana Transaction”), BGM shall pay Humana a [***] of Net Sales to such Persons as follows:

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

8

 

(a)                                  With
respect to any BGM Commercialized Diagnostic Product [***] based on data or
services from a Covered Project in which Humana participates, BGM shall pay
Humana a [***] equal to [***]% of Net Sales:

 

(b)                                 Notwithstanding
Section 5.2.1(a), with respect to any BGM Commercialized Diagnostic Product,
that was [***] based on data or services from a Covered Project in which Humana
participates, BGM shall pay Humana a [***] equal to [***]% of Net Sales.

 

5.2.2                     The payment [***] pursuant to Section 5.2.1
shall be subject to the following conditions:

 

(a)                                  BGM’s
obligations under this Section 5.2 shall apply to all BGM Commercialized
Diagnostic Products that were [***] during the term [***]. If BGM ever has a Valid Claim with respect
to a particular BGM Commercialized Diagnostic Product, [***] on Net Sales of
such BGM Commercialized Diagnostic Product pursuant to Section 5.2.1 shall
continue and accrue until the [***] such BGM Commercialized Diagnostic Product,
[***] the term [***] has [***]. Thereafter, BGM [***] [***] [***] BGM
Commercialized Diagnostic Product.

 

(b)                                 [***] [***] shall accrue on the disposition
of reasonable quantities of BGM Commercialized Diagnostic Products by BGM or
Affiliates as samples (promotion or otherwise) or as donations (for example, to
non-profit institutions or government agencies) or to clinical trials.

 

5.2.3                     In the event that BGM transfers BGM
Commercialized Diagnostic Products to one of its Affiliates, there shall be
[***] at the [***] transfer. Subsequent sales of BGM Commercialized Diagnostic
Products by the Affiliate to end users shall be [***] by BGM.

 

5.2.4                     Within [***] days after the end of each [***]
of BGM, BGM shall deliver to Humana a statement of its calculation of Net Sales
derived from sales of BGM Commercialized Diagnostic Products during such [***]
in [***] and any amounts due Humana with respect thereto, calculated as set
forth in Section 5.2.1 (each such statement, a [***]
Statement”).

 

5.2.5                     BGM shall pay Humana any amounts due with
respect to a particular [***] by wire transfer to a bank account designated by
Humana within [***] days following delivery of the [***] Statement for such
[***].

 

5.3                               Combination
Products. In the event that a BGM Commercialized Diagnostic Product is (a)
sold [***] or (b) [***] component, then in each case ((a) and (b)), the sales
price for such combination product shall be [***], based on [***] BGM
Commercialized Diagnostic Product [***] in such [***] if [***], for purposes of
calculating the applicable MFN Price or the Net Sales; provided,
that if such BGM Commercialized Diagnostic Product is [***], the Parties shall
negotiate in good faith an estimate value thereof.

 

5.4                               Best
Price Regulation. If at any time during the Term, a [***] caps the price
of, imposes a “best price” requirement on, or otherwise establishes a rebate or
similar scheme for, a

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

9

 

particular BGM Commercialized Diagnostic Product in
the United States, including any program that is similar to the treatment of
pharmaceutical products under [***], then, from and after the effective date
thereof, the MFN Price with respect to such BGM Commercialized Diagnostic
Product shall [***] the price permitted by such requirement.

 

ARTICLE 6

RECORDS AND AUDIT

 

6.1                               Financial
Records. Each Party shall, and shall cause its Affiliates to, keep
reasonably complete and accurate books and records in sufficient detail to
calculate the amounts payable under this Agreement including, with respect to
BGM, books and records pertaining to MFN Prices and the preparation of each
[***] Statement, and, with respect to Humana, books and records pertaining to
the conduct of Services hereunder. All such books and records shall be retained
by such Party and its Affiliates until the later of (a) three (3) years after
the end of the period to which such books and records pertain and (b) the
expiration of the applicable tax statute of limitations (or any extensions
thereof), or for such longer period as may be required by Applicable Law.

 

6.2                               Audits.
Each Party shall have the right, no more than once during any twelve (12)
consecutive month period during the Term and a period of one (1) year
thereafter, to have the books and records kept by the other Party (and its
Affiliates) pursuant to Section 6.1 (and all related work papers and other
information and documents) examined by an independent accounting firm of
national standing reasonably acceptable to such other Party to verify the
correctness or completeness of any report or payment made under this Agreement,
provided that if any audit by a Party
under this Section 6.2 reveals that the other Party is or was not in material
compliance with this Agreement, the auditing Party shall have the right to
conduct such additional audits during such (12)-consecutive month period as may
be reasonably required by such auditing Party to determine whether the other
Party has appropriately remedied such non-compliance. Except as provided below,
the cost of any audit shall be borne by the auditing Party unless the audit
reveals a variance of more than five percent (5%) from the reported amounts, in
which case the other Party shall bear the cost of the audit. Unless disputed
pursuant to Section 6.3 below, if such audit concludes that additional payments
were owed or that excess payments were made during such period, the additional
fees and expenses shall be paid, or such excess payments shall be reimbursed,
within sixty (60) days after the date on which the independent accounting firm’s
written report is delivered to the Parties.

 

6.3                               Audit
Dispute. In the event of a dispute regarding such books and records,
including the amount of any payments owed, or other payments made, hereunder,
BGM and Humana shall work in good faith to resolve the disagreement. If the
Parties are unable to reach a mutually acceptable resolution of any such
dispute within thirty (30) days, the dispute shall be submitted for arbitration
to a certified public accounting firm selected by each Party’s certified public
accountants or to such other Person as the Parties shall mutually agree. The
decision of such accounting firm shall be final and the costs of such
arbitration as well as the initial audit shall be borne between the Parties in
such manner as such accounting firm shall determine. Not later than ten (10)
days after such decision, the owing Party shall pay the additional payments or
the receiving Party shall reimburse such excess payments in accordance with
such decision.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

10

 

6.4                               Confidentiality.
Each Party shall treat all information subject to review under this Article 6
in accordance with the confidentiality provisions of Article 7 and the Parties
shall cause any auditor or accounting firm to enter into a reasonably
acceptable confidentiality agreement with the Parties obligating such firm to
retain all such financial information in confidence pursuant to such
confidentiality agreement.

 

ARTICLE 7

CONFIDENTIALITY AND NON-DISCLOSURE

 

7.1                               Confidentiality
Obligations. At all times during the Term and for a period of ten (10)
years following termination or expiration hereof, each Party shall, and shall
cause its officers, directors, employees and agents to, keep completely
confidential and not publish or otherwise disclose and not use, directly or
indirectly, for any purpose, any Confidential Information furnished or
otherwise made known to it, directly or indirectly, by the other Party, except
to the extent such disclosure or use is expressly permitted by the terms of
this Agreement or is reasonably necessary for the performance of this
Agreement.

 

7.2                               Permitted
Disclosures. Each Party may disclose Confidential Information of the other
Party to the extent that such disclosure is:

 

7.2.1                     Made in
response to a valid order of a court of competent jurisdiction or other
supra-national, federal, national, regional, state, provincial and local
governmental or regulatory body of competent jurisdiction or, if in the
reasonable opinion of the receiving Party’s legal counsel, such disclosure is
otherwise required by law; provided, however,
that the receiving Party shall first have given reasonable notice under the
circumstances to the disclosing Party; and provided further
that if a disclosure order is not quashed or a protective order is not
obtained, the Confidential Information disclosed in response to such court or
governmental order shall be limited to that information which is legally
required to be disclosed in response to such court or governmental order;

 

7.2.2                     Made by
the receiving Party to the Regulatory Authorities as required in connection
with any filing, application or request with respect to the Services; provided, however, that reasonable measures shall be taken
to assure confidential treatment of such information; or

 

7.2.3                     Made by
the receiving Party or its Affiliates to Third Parties as may be necessary or
reasonably useful in connection with the performance of its obligations or
exercise of its rights as contemplated by this Agreement, including
subcontracting transactions in connection therewith; provided,
however, that such disclosure may only be made to such Persons as
are subject to obligations of written confidentiality and non-use with respect
to such Confidential Information at least as restrictive as the obligations of
confidentiality and non-use of the receiving Party set forth in this Article 7.

 

7.3                               Use
of Name. Neither Party shall mention or otherwise use the name, insignia,
symbol, Trademark, trade name or logotype of the other Party (or any
abbreviation or adaptation thereof) in any publication, press release,
promotional material or other form of publicity without the prior written
approval of such other Party in each instance. The restrictions imposed by this

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

11

 

Section 7.3 shall not prohibit either Party from
making any disclosure identifying the other Party that is required by
Applicable Law or necessary to exercise its rights or perform its obligations
under this Agreement.

 

7.4                               Press
Releases. Press releases or other similar public communications by either
Party relating to this Agreement shall be approved in advance by the other
Party, which approval shall not be unreasonably withheld or delayed, except for
those communications required by Applicable Law (which, to the extent possible,
shall be provided to the other Party in advance for such Party’s comment, or if
not possible, shall be provided to the other Party as soon as practicable after
the release or communication thereof), and disclosures of information for which
consent has previously been obtained, each of which shall not require advance
approval.

 

7.5                               Return
of Confidential Information. Upon the expiration or earlier termination of
this Agreement or as earlier requested by the disclosing Party, the receiving
Party shall promptly transfer to the disclosing Party all documentary,
electronic or other tangible embodiments of the disclosing Party’s Confidential
Information, including any and all copies thereof, and those portions of any
documents that incorporate or are derived from such Confidential Information.

 

7.6                               Enforceability.
The provisions of this Article 7 shall be specifically enforceable. Each Party acknowledges
that its breach of any of its obligations under this Article 7 may cause the
disclosing Party irreparable harm, for which monetary damages will be an
inadequate remedy. Therefore, in the event of any such breach, the disclosing
Party shall be entitled, in addition to any other remedy available under this
Agreement, at law or in equity, to seek injunctive relief, specific performance
of the terms hereof and other equitable relief for such breach or the material
anticipatory breach of this Agreement.

 

ARTICLE 8

REPRESENTATIONS AND WARRANTIES

 

8.1                               Representations
and Warranties. Each Party hereby represents and warrants to the other
Party as of the Effective Date as follows:

 

8.1.1                     Corporate
Authority. Such Party (a) has the power and authority and the legal right
to enter into this Agreement and perform its obligations hereunder and (b) has
taken all necessary action on its part required to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of such Party and
constitutes a legal, valid and binding obligation of such Party and is
enforceable against it in accordance with its terms subject to the effects of
bankruptcy, insolvency or other laws of general application affecting the
enforcement of creditor rights and judicial principles affecting the
availability of specific performance and general principles of equity, whether
enforceability is considered a proceeding at law or equity.

 

8.1.2                     Litigation.
To its Knowledge, there is no pending or threatened litigation that alleges
that such Party’s activities related to this Agreement have violated, or that
by conducting the activities as contemplated herein such Party would violate,
any of the patent or intellectual property rights of any other Person.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

12

 

8.1.3                     Consents and
Approvals. All necessary consents, approvals and authorizations of all
regulatory and governmental authorities and other Persons required to be
obtained by such Party in connection with the execution and delivery of this
Agreement and the performance of its obligations hereunder have been obtained.

 

8.1.4                     Conflicts.
The execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder (a) do not conflict with or violate any requirement of
applicable law or regulation or any provision of the articles of incorporation,
bylaws or limited partnership agreement or any similar instrument of such
Party, as applicable, in any material way, and (b) do not conflict with,
violate or breach or constitute a default or require any consent under, any
contractual obligation or court or administrative order by which such Party is
bound.

 

8.2                               Additional
Representations, Warranties and Covenants of Humana. Humana represents,
warrants and covenants to BGM as of the Effective Date as follows:

 

8.2.1                     Humana
has been selected to conduct the Services because of its experience, expertise
and resources and not, in any way, as an inducement to, or in return for, past,
present or future prescribing, purchasing, recommending, using, obtaining
preferential formulary status for or dispensing any BGM Commercialized
Diagnostic Product or any drug products of BGM; and

 

8.2.2                     Neither
Humana nor any of its Affiliates has been debarred or is subject to debarment
and neither Humana nor any of its Affiliates shall use in any capacity, in
connection with its activities under this Agreement, any Person who has been
debarred pursuant to Section 306 of the FFDCA or who is the subject of a
conviction described in such section. Humana shall inform BGM in writing
immediately if it or any of the foregoing Persons is debarred or is the subject
of a conviction described in Section 3.4, or if any action, suit, claim,
investigation or legal or administrative proceeding is pending or, to the best
of Humana’s Knowledge, is threatened, relating to the debarment or conviction
of Humana or any Person performing services on behalf of Humana hereunder.

 

8.3                               DISCLAIMER
OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 8.1
AND 8.2 OR SUCH WARRANTIES AS MAY BE SET FORTH IN A RESEARCH COLLABORATION
AGREEMENT, WHICH SHALL BE GOVERNED BY SUCH RESEARCH COLLABORATION AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR
IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND
EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR
ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY
OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY
OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES.

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

13

 

ARTICLE 9

INDEMNITY

 

9.1                               Indemnification
of BGM. Humana shall indemnify BGM, its Affiliates and their respective
directors, officers, employees, licensors and agents, and defend and save each
of them harmless, from and against any and all losses, damages, liabilities,
costs and expenses (including reasonable attorneys’ fees and expenses)
(collectively, “Losses”) in connection with any
and all suits, investigations, claims or demands of Third Parties
(collectively, “Third Party Claims”) arising from
or occurring as a result of:  (a) the
breach by Humana of any term of this Agreement; or (b) any gross negligence or
willful misconduct on the part of Humana or any of its Affiliates or
sublicensees in performing Humana’s obligations under this Agreement, except
for those Losses which BGM has an obligation of indemnity pursuant to Section 9.2,
as to which Losses each Party shall indemnify the other to the extent of their
respective liability; provided, however,
that Humana shall not be obligated to indemnify BGM for any Losses to the
extent that such Losses arise as a result of gross negligence or willful
misconduct on the part of BGM or any of its Affiliates or sublicensees.

 

9.2                               Indemnification
of Humana. BGM shall indemnify Humana, its Affiliates and their respective
directors, officers, employees and agents, and defend and save each of them
harmless, from and against any and all Losses in connection with any and all
Third Party Claims arising from or occurring as a result of: (a) the breach by
BGM of this Agreement; or (b) any gross negligence or willful misconduct on the
part of BGM or any of its Affiliates in performing its obligations under this
Agreement, except for those Losses for which Humana has an obligation of
indemnity pursuant to Section 9.1, as to which Losses each Party shall
indemnify the other to the extent of their respective liability for the Losses;
provided, however, that BGM shall not be
obligated to indemnify Humana for any Losses to the extent that such Losses
arise as a result of gross negligence or willful misconduct on the part of
Humana or any of its Affiliates.

 

9.3                               Indemnification
Process. The Person seeking indemnification (the “Indemnitee”)
hereunder shall give notice to the indemnifying Party promptly upon receipt of
written notice of the potential Third Party Claim for which indemnification may
be sought under this Agreement. The Indemnitee shall permit the indemnifying
Party to assume the defense or disposition of any such Third Party Claim or
related litigation, provided that
counsel is reasonably acceptable to the Indemnitee; and provided
further, that the indemnifying Party shall not make any settlement
admitting fault or incur any liability on the part of the Indemnitee without
its written consent, such consent not to be unreasonably withheld or delayed. The
Indemnitee shall cooperate with the indemnifying Party in all reasonable
respects with respect to the defense of any such Third Party Claim, with the
out-of-pocket costs of the Indemnitee to be reimbursed by the indemnifying
Party. The Indemnitee shall be entitled to retain counsel of its choice (at is own
expense) to participate in, but not control (except as provided below), the
defense of any Third Party Claim. The Indemnitee shall be entitled to control
the defense of such Third Party Claim at the indemnifying Party’s expense if
(a) the indemnifying Party has failed to assume the defense of such Third Party
Claim in a reasonably prompt manner or with counsel reasonably satisfactory to
the Indemnitee or (b) the interests of the Indemnitee and the indemnifying
Party with respect to such Third Party Claim are sufficiently adverse to
prohibit the representation by the same counsel of both parties under
applicable law, ethical rules or equitable

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

14

 

principles. In no event shall the Indemnitee
compromise, settle or otherwise admit any liability with respect to any claim
without the prior written consent of the indemnifying Party (such consent not
to be unreasonably withheld or delayed).

 

9.4                               Limitation
on Damages and Liability. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR
INTENTIONAL MISCONDUCT BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO THIRD
PARTY CLAIMS UNDER SECTION 9.1 OR 9.2, NO PARTY OR ANY OF THEIR RESPECTIVE
AFFILIATES SHALL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES, OR FOR LOST PROFITS, MILESTONES OR ROYALTIES, WHETHER IN CONTRACT,
WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF THE
EXPLOITATION OF ANY DIAGNOSTIC PRODUCT UNDER THIS AGREEMENT, OR ANY BREACH OF
OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT.

 

9.5                               Insurance.
Each Party shall have and maintain such type and amounts of liability insurance
covering the supply, use and sale of each Product as is normal and customary
for parties similarly situated. Each Party shall, at the other Party’s request,
furnish to the other Party a certificate of insurance or evidence of
self-insurance reasonably acceptable to the other Party indicating the required
coverage.

 

ARTICLE 10

TERM AND TERMINATION

 

10.1                        Term. Unless
earlier terminated pursuant to this Article 10, this Agreement shall be
effective as of the Effective Date and shall continue for three (3) years (the “Initial Term”), and thereafter, unless either Party provides
written notice to the other Party no later than one hundred twenty (120) days
prior to the end of the Initial Term, shall automatically continue for an
additional twelve (12)-month period (the “Renewal Term,”
and together with the Initial Term, the “Term”); provided, however, that solely with respect to any Research
Collaboration Agreements entered into prior to such expiration or termination,
this Agreement shall remain in effect until the expiration or earlier
termination of such Research Collaboration Agreements.

 

10.2                        Termination
for Material Breach. In the event that either Party (the “Breaching Party”) shall be in material default in the
performance of any of its material obligations under this Agreement or any
Research Collaboration Agreement, in addition to any other right and remedy the
other Party (the “Complaining Party”)
may have, the Complaining Party may terminate this Agreement or such Research
Collaboration Agreement, in its entirety 
upon sixty (60) days’ prior written notice (the “Notice
Period”) to the Breaching Party, specifying the breach and its claim
of right to terminate, provided that
the termination shall not become effective at the end of the Notice Period if
the Breaching Party cures the breach during the Notice Period (or, if such
default cannot be cured within such sixty (60)-day period, if the Breaching
Party commences actions to cure such default within the Notice Period and
thereafter diligently continues such actions, provided
that such default is cured within ninety (90) days after the receipt of such
notice), except in the case of a payment default, as to which the Breaching
Party shall have only a ten (10)-day cure period. In the event that Humana is
the Breaching Party with respect to a Research Collaboration Agreement, BGM
shall also have the

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

15

 

right to terminate this Agreement and any other
Research Collaboration Agreements then in effect.

 

10.3                        Termination
Upon Insolvency. Either Party may terminate this Agreement or any Research
Collaboration Agreement if, at any time, the other Party shall file in any
court or agency pursuant to any statute or regulation of any state, country or
jurisdiction, a petition in bankruptcy or insolvency or for reorganization or
for an arrangement or for the appointment of a receiver or trustee of that
Party or of its assets, or if the other Party proposes a written agreement of composition
or extension of its debts, or if the other Party shall be served with an
involuntary petition against it, filed in any insolvency proceeding, and such
petition shall not be dismissed within sixty (60) days after the filing
thereof, or if the other Party shall propose or be a Party to any dissolution
or liquidation, or if the other Party shall make an assignment for the benefit
of its creditors.

 

10.4                        Accrued
Rights; Surviving Obligations

 

10.4.1              Accrued Rights. Termination
or expiration of this Agreement for any reason shall be without prejudice to
any rights that shall have accrued to the benefit of a Party prior to such
termination or expiration. Such termination or expiration shall not relieve a
Party from obligations that are expressly indicated to survive the termination
or expiration of this Agreement.

 

10.4.2              Survival. Without
limiting the foregoing, Articles 6, 7, 8, and 9, Article 5 to the extent
provided therein, and Sections 11.4, 11.5, and this Section 10.4 shall survive
the termination or expiration of this Agreement for any reason.

 

10.4.3              Remedies. All
remedies provided hereunder are cumulative and concurrent, and are in addition
to all other available remedies at law or in equity; provided,
however, that a Party shall not seek to avail itself of such other
remedies (except for any equitable remedy) during any cure period under this
Agreement. This Section shall be specifically enforceable.

 

ARTICLE 11

MISCELLANEOUS

 

11.1                        Force
Majeure. Neither Party shall be held liable or responsible to the other
Party or be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from events beyond the reasonable
control of the non-performing Party, including fires, floods, earthquakes,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be
declared or not), terrorist acts, insurrections, riots, civil commotion,
strikes, lockouts or other labor disturbances (whether involving the workforce
of the non-performing Party or of any other Person), acts of God or acts,
omissions or delays in acting by any governmental authority. The non-performing
Party shall notify the other Party of such force majeure within thirty (30)
days after such occurrence by giving written notice to the other Party stating
the nature of the event, its anticipated duration, and any action being taken
to avoid or minimize its effect. The suspension of performance shall be of no
greater scope and no longer duration than is necessary

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

16

 

and the non-performing Party shall use commercially
reasonable efforts to remedy its inability to perform.

 

11.2                        Assignment.
Neither Party shall sell, transfer, assign, delegate, pledge or otherwise
dispose of, whether voluntarily, involuntarily, by operation of law or
otherwise, this Agreement or any of its rights or duties hereunder without the
prior written consent of the other Party; provided, however,
that BGM may, without such consent, assign this Agreement and its rights and
obligations hereunder to an Affiliate or a successor in interest (whether by
merger, acquisition, asset purchase or otherwise) to all or substantially all
of the business to which this Agreement relates; provided
further that the assigning Party remains jointly and severally
liable with the relevant Affiliate or successor in interest under this
Agreement. Any attempted assignment or delegation in violation of the preceding
sentence shall be void and of no effect. All validly assigned and delegated
rights and obligations of the Parties hereunder shall be binding upon and inure
to the benefit of and be enforceable by and against the successors and
permitted assigns of BGM or Humana, as the case may be.

 

11.3                        Severability.
If any provision of this Agreement is held to be illegal, invalid or
unenforceable under any present or future law, and if the rights or obligations
of either Party under this Agreement shall not be materially and adversely
affected thereby, (a) such provision shall be fully severable, (b) this
Agreement shall be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall
not be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom and (d) in lieu of such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar in terms to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the Parties. To the fullest extent permitted by Applicable Law, each Party
hereby waives any provision of law that would render any provision hereof
illegal, invalid or unenforceable in any respect.

 

11.4                        Governing
Law, Jurisdiction, Venue and Service.

 

11.4.1              Governing Law. This
Agreement shall be governed by and construed in accordance with the laws of the
State of Florida, excluding any conflicts or choice of law rule or principle
that might otherwise refer construction or interpretation of this Agreement to
the substantive law of another jurisdiction.

 

11.4.2              Jurisdiction. The
Parties hereby irrevocably and unconditionally consent to the exclusive
jurisdiction of the courts of the State of Florida and the United States
District Court for the Southern District of Florida for any action, suit or
proceeding (other than appeals therefrom) arising out of or relating to this
Agreement, and agree not to commence any action, suit or proceeding (other than
appeals therefrom) related thereto except in such courts. The Parties
irrevocably and unconditionally waive their right to a jury trial.

 

11.4.3              Venue. The
Parties further hereby irrevocably and unconditionally waive any objection to
the laying of venue of any action, suit or proceeding (other than appeals
therefrom) arising out of or relating to this Agreement in the courts of the
State of Florida or in the United States District Court for the Southern
District of Florida, and hereby further

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

17

 

irrevocably and unconditionally waive and agree not to
plead or claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient forum.

 

11.4.4              Service. Each
Party further agrees that service of any process, summons, notice or document
by registered mail to its address set forth in Section 11.5 shall be effective
service of process for any action, suit or proceeding brought against it under
this Agreement in any such court.

 

11.5                        Notices.

 

11.5.1              Notice Requirements.
Any notice or other communication required or permitted under this Agreement
shall be in writing and shall be deemed given as of the date it is: (a) delivered
by hand, or (b) mailed, postage prepaid, first class, certified mail, return
receipt requested, to the other Party at such Party’s address listed below or
subsequently specified in writing, or (c) sent, shipping prepaid, return
receipt requested, by national courier service, to the other Party at  such Party’s address listed below or
subsequently specified in writing. This Section is not intended to govern the
day-to-day business communications necessary between the Parties in performing
their obligations under the terms of this Agreement.

 

	
  As to
  Humana:

  	
  Humana Inc.

  
	
   

  	
  500 West
  Main Street

  
	
   

  	
  Louisville,
  KY 40202

  
	
   

  	
  Attn: Law
  Department

  
	
   

  	
   

  
	
  cc:

  	
  Jennifer
  Geetter, Esq.

  
	
   

  	
  McDermott
  Will & Emery LLP

  
	
   

  	
  600 13th
  Street, N.W.

  
	
   

  	
  Washington,
  D.C. 20005

  
	
   

  	
   

  
	
  As to BGM:

  	
  BG Medicine

  
	
   

  	
  610 N
  Lincoln Street

  
	
   

  	
  Waltham, MA
  02451

  
	
   

  	
  Attn:
  President

  
	
   

  	
   

  
	
  cc:

  	
  William T.
  Whelan, Member

  
	
   

  	
  Mintz,
  Levin, Cohn, Ferris, Glovsky

  
	
   

  	
  and Popeo,
  P.C.

  
	
   

  	
  One
  Financial Center | Boston, MA 02111

  

 

11.6                        Entire
Agreement; Amendments.

 

11.6.1              This Agreement
and its attached Exhibits represent the entire understanding among the Parties,
and supersedes all other agreements, express or implied, between the Parties as
to its subject matter. Any alteration, modification, or amendment to this
Agreement must be in writing and signed by each Party. The attached Exhibits
are incorporated into this Agreement by reference. Each Party confirms that it
is not relying on any

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

18

 

representations or warranties of the other Party
except as specifically set forth herein. No amendment, modification, release or
discharge shall be binding upon the Parties unless in writing and duly executed
by authorized representatives of both Parties.

 

11.6.2              The Parties
acknowledge that they are currently negotiating a separate agreement pursuant
to which Humana will assist BGM and others in conducting a research study
examining the role of high risk plaque in the development of cardiovascular
disease (the “Plaque Agreement”). The Plaque
Agreement is separate and independent from this Agreement and is not affected,
modified, subject to, or superceded by this Agreement.

 

11.7                        Waiver and
Non-Exclusion of Remedies. Any term or condition of this Agreement may be
waived at any time by the Party that is entitled to the benefit thereof, but no
such waiver shall be effective unless set forth in a written instrument duly
executed by or on behalf of the Party waiving such term or condition. The
waiver by either Party hereto of any right hereunder or of the failure to
perform or of a breach by the other Party shall not be deemed a waiver of any
other right hereunder or of any other breach or failure by said other Party
whether of a similar nature or otherwise.

 

11.8                        Applicability
to Other Persons.

 

11.8.1              The
representations, warranties, covenants and agreements set forth in this
Agreement are for the sole benefit of the Parties hereto and their successors
and permitted assigns, and they shall not be construed as conferring any rights
on any other Persons. For the avoidance of doubt, all present and existing
subsidiaries of Humana Inc. that underwrite or administer health plans shall be
considered Parties and shall be entitled to the benefits accruing to Humana
hereunder.

 

11.8.2              The obligations
of BGM under this Agreement with respect to any BGM Commercialized Diagnostic
Product shall apply to and bind any direct or indirect transferee of rights
with respect to such product line, whether by means of sale of the product
line, sale, merger, or consolidation of BGM, or any other transfer of the
product line, and also to any licensee of rights to the product line
(collectively “Product Line Successors”). BGM
shall assure that all agreements with Product Line Successors expressly provide
for their assumption of such obligations. BGM shall also continue to be liable
to Humana for all obligations with respect to such product lines,
notwithstanding any direct or indirect transfer of the product lines or the
assumption of obligations with respect thereto by Product Line Successors.

 

11.9                        Further
Assurance. Each Party shall duly execute and deliver, or cause to be duly
executed and delivered, such further instruments and do and cause to be done
such further acts and things, including the filing of such assignments,
agreements, documents and instruments, as may be necessary or as the other
Party may reasonably request in connection with this Agreement or to carry out
more effectively the provisions and purposes hereof, or to better assure and
confirm unto such other Party its rights and remedies under this Agreement.

 

11.10                 Relationship of
the Parties. It is expressly agreed that BGM and Humana shall be
independent contractors and that the relationship between the two Parties shall
not constitute a

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

19

 

partnership, joint venture or agency. Neither BGM nor
Humana shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other, without the prior written consent of the other Party to do so, such
consent not to be unreasonably withheld or delayed.

 

11.11                 Counterparts.
This Agreement may be executed in two (2) or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and
the same instrument. This Agreement may be executed by facsimile signatures and
such signatures shall be deemed to bind each party hereto as if they were
original signature.

 

11.12                 References. Unless
otherwise specified, (a) references in this Agreement to any Article, Section
or Exhibit shall mean references to such Article, Section or Exhibit of this
Agreement, (b) references in any section to any clause are references to such
clause of such section and (c) references to any agreement, instrument or other
document in this Agreement refer to such agreement, instrument or other
document as originally executed or, if subsequently varied, replaced or
supplemented from time to time, as so varied, replaced or supplemented and in
effect at the relevant time of reference thereto.

 

11.13                 Construction.
Except where the context otherwise requires, wherever used, the singular shall
include the plural, the plural the singular, the use of any gender shall be
applicable to all genders and the word “or” is used in the inclusive sense
(and/or). The captions of this Agreement are for convenience of reference only
and in no way define, describe, extend or limit the scope or intent of this
Agreement or the intent of any provision contained in this Agreement. The term “including”
as used herein shall mean including, without limiting the generality of any
description preceding such term. The language of this Agreement shall be deemed
to be the language mutually chosen by the Parties and no rule of strict
construction shall be applied against either Party hereto.

 

[Signature Page Follows]

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

20

 

THIS AGREEMENT
IS EXECUTED by the authorized representatives of the Parties as of the date
first written above.

 

	
  HUMANA INC.

  	
   

  	
  BG MEDICINE,
  INC.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Signature:

  	
  /s/ Carol J.
  McCall

  	
   

  	
  Signature:

  	
  /s/ Pieter
  Muntendam

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Carol J. McCall

  	
   

  	
  Name:

  	
  Pieter
  Muntendam

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  VP of
  Research and Development

  	
   

  	
  Title:

  	
  President
  and CEO

  	
   

  
										

 

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act.

 

21

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