Exhibit 10.41
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
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LICENSE AGREEMENT
     THIS LICENSE AGREEMENT (“Agreement”) is made effective as of the 18th day
of December, 2009 (the “Effective Date”), by and between The Medicines Company,
a corporation organized and existing under the laws of Delaware with offices at
8 Sylvan Way, Parsippany, NJ 07054 (“LICENSEE”), and Pfizer Inc., a corporation
organized and existing under the laws of Delaware with offices at 235 East 42nd
Street, New York, NY 10017 (“PFIZER”). LICENSEE and PFIZER may, from
time-to-time, be individually referred to as a “Party” and collectively referred
to as the “Parties”.
RECITALS
     WHEREAS, PFIZER Controls the Licensed Technology (hereinafter defined); and
     WHEREAS, LICENSEE wishes to obtain, and PFIZER wishes to grant, certain
licenses under the Licensed Technology on the terms and conditions set forth
herein.
     NOW, THEREFORE, in consideration of the mutual agreements and covenants set
forth herein and other good and valuable consideration, the receipt and
sufficiency of which the Parties hereby acknowledge, the Parties, intending to
be legally bound hereby, agree to the foregoing and as follows:

1.   DEFINITIONS

  1.1.   “Affiliate” means, with respect to a Party, any Person that controls,
is controlled by, or is under common control with that Party. For the purpose of
this definition, “control” shall refer to: (a) the possession, directly or
indirectly, of the power to direct the management or policies of an entity,
whether through the ownership of voting securities, by contract or otherwise, or
(b) the ownership, directly or indirectly, of fifty percent (50%) or more of the
voting securities of such entity.     1.2.   “Applicable Laws” means all
applicable laws, statutes, rules, regulations and guidelines, including all good
manufacturing practices and all applicable standards or guidelines promulgated
by the appropriate Regulatory Authority, the rules of the Securities and
Exchange Commission or any stock exchange and any court order or other
governmental order.     1.3.   “Bankruptcy Code” has the meaning as set forth in
Section 13.3.     1.4.   “Bankruptcy Event” has the meaning as set forth in
Section 13.3.     1.5.   “Business Day” means any day other than a Saturday, a
Sunday or a day on which commercial banks located in New York, New York are
authorized or required by law to remain closed.     1.6.   “Calendar Quarter”
means each of the three (3) month periods commencing on January 1, April 1, July
1 and October 1 of any year.

 

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  1.7.   “Calendar Year” means the twelve (12) month period commencing on
January 1 and each successive twelve (12) month period thereafter.     1.8.  
“cGMP” means current Good Manufacturing Practices and standards as provided for
in the 21 CFR Parts 210-211 and in European Community Directive 91/356/EEC, each
as amended from time to time.     1.9.   “Combination Product” means any
pharmaceutical product containing: (a) a Compound(s) and (b) one or more other
therapeutically active ingredients which are not Compounds.     1.10.  
“Commence” or “Commencement” when used with respect to a clinical trial, means
the first dosing of the first patient for such trial.     1.11.  
“Commercialize” or “Commercialization” means to manufacture for sale, market,
promote, otherwise offer for sale, distribute, and sell.     1.12.  
“Commercially Reasonable Efforts” means, with respect to a Product: (a) with
respect to Development of such Product, the efforts, budget, headcount and
expenditures that are directed toward seeking to obtain Regulatory Approval and
are comparable to those used by LICENSEE for one of LICENSEE’s products that is
at a similar stage of development and has similar commercial potential as such
Product, and (b) with respect to Commercialization of such Product, the efforts,
budget, headcount and expenditures that are comparable to those used by LICENSEE
for any of LICENSEE’s products that has similar commercial potential as such
Product; in each of cases (a) and (b), as determined on a country-by-country
basis by reference to relevant scientific, regulatory and commercial factors
including product safety and efficacy profile, development risk, regulatory
environment, patent and other exclusivity protections and risks, anticipated
market size, competition from other products or treatments, product labeling or
anticipated labeling and competitive market conditions, all as measured by the
facts and circumstances at the time such efforts are due.     1.13.   “Compound”
means each of the following, separately: ETC-216, alone, and each Improvement
thereto. ETC-216 and each modified version of ETC-216 which is an Improvement
shall be considered a separate Compound for purposes of this Agreement.    
1.14.   “Control” or “Controlled” means, with respect to any Intellectual
Property Rights, the legal authority or right (whether by ownership, license or
otherwise, other than pursuant to a license granted under this Agreement) of a
Party to grant a license or a sublicense of or under such Intellectual Property
Rights to the other Party without breaching the terms of any agreement with a
Third Party.     1.15.   “Cover”, “Covering” or “Covered” means, with respect to
a Compound or Product, in the absence of a license granted under a Valid Claim,
the Use of such Compound or Product would infringe such Valid Claim (or, in the
case of a Valid Claim that has not yet issued, would infringe such Valid Claim
if it were to issue).

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  1.16.   “Danisco” has the meaning as set forth in Section 2.1.3.     1.17.  
“Danisco Agreement” has the meaning as set forth in Section 2.1.3.     1.18.  
“Danisco IP” has the meaning as set forth in Section 2.1.3.     1.19.  
“Develop” or “Development” means to conduct research and development activities,
and related manufacturing activities, necessary to obtain or for the purpose of
obtaining or maintaining Regulatory Approval.     1.20.   “EMEA” means the
European Medicines Agency, or any successor agency thereof.     1.21.  
“ETC-216” means the compound designated by PFIZER as ETC-216 as described in
Schedule A hereto in the form existing as of the Effective Date.     1.22.  
“Europe” means the member states of the European Union, as constituted from time
to time.     1.23.   “FDA” means the United States Food and Drug Administration,
or a successor federal agency thereto.     1.24.   “Field” means all
therapeutic, prophylactic and diagnostic uses in humans and animals.     1.25.  
“First Commercial Sale” means, with respect to a Product in a country in the
Territory, the first sale for use or consumption by the general public of such
Product following receipt of Regulatory Approval for such Product in such
country.     1.26.   “GAAP” means the generally accepted accounting principles
set forth in the opinions and pronouncements of the Accounting Principles Board
of the American Institute of Certified Public Accountants and statements and
pronouncements of the Financial Accounting Standards Board.     1.27.  
“Improvements” means, with respect to ETC-216, any change or modification
thereof, including amino acid deletions, additions, duplications and
substitutions, and chemical or physical modifications thereto, in each case to
the extent such modified ETC-216 is or has been Covered by a Valid Claim under
the Patent Rights.     1.28.   “IND” means: (a) an investigational new drug
application filed with the FDA for authorization for the clinical investigation
of a Product, and (b) any of its foreign equivalents as filed with the
applicable Regulatory Authorities in other countries or regulatory jurisdictions
in the Territory, as applicable.     1.29.   “Intellectual Property Rights”
means all trade secrets, copyrights, patents, patent applications and other
patent rights, Trademarks, moral rights, and any and all other intellectual
property or proprietary rights now known or hereafter recognized in any
jurisdiction.

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  1.30.   “Know-How” means the confidential or proprietary information and data
(including pre-clinical, clinical and manufacturing data but specifically
excluding the Patent Rights and the Danisco IP) Controlled by PFIZER as of the
Effective Date, which PFIZER or its Affiliates have applied to or incorporated
into ETC-216 and which are necessary or optimal for LICENSEE to Use ETC-216.    
1.31.   “Knowledge” means the actual present knowledge of PFIZER’s current
patent counsel with responsibility for intellectual property matters relating to
ETC-216, and current director of regulatory affairs matters relating to ETC-216,
and is not meant to require or imply that any particular inquiry or
investigation has been undertaken including obtaining any type of search
(independent of that performed by the actual governmental authority during the
normal course of patent prosecution, as applicable, in a jurisdiction) or
opinion of counsel     1.32.   “Licensed Technology” means collectively, the
Patent Rights and Know-How.     1.33.   “Major European Country” means any of
the following countries: France, Germany, Italy, Spain and the United Kingdom.  
  1.34.   “Milestone” means each milestone as set forth in Section 5.1.2.    
1.35.   “NDA/BLA” means: (a) a new drug application or a new biologic license
application filed with the FDA for authorization for marketing a Product, and
(b) any of its foreign equivalents as filed with the applicable Regulatory
Authorities in other countries or regulatory jurisdictions in the Territory, as
applicable, including a Marketing Authorization Application (“MAA”).     1.36.  
“Net Sales” means the gross amount invoiced by or on behalf of LICENSEE, its
Affiliates and their respective sublicensees (the “Selling Party”) for sales of
the relevant Product (other than sales by a Selling Party to LICENSEE, its
Affiliates or sublicensees for subsequent resale, in which case the sale
thereafter by LICENSEE, its Affiliates or sublicensees to a Third Party other
than a Selling Party (an “End User”) shall be used for calculation of Net
Sales), provided, however, that if the price invoiced by LICENSEE for the
transfer to such Affiliate or sublicensee is higher than the price invoiced by
such Affiliate or sublicensee for the subsequent resale to the End User, the Net
Sales shall be determined on the gross amount invoiced by LICENSEE to such
Affiliate or sublicensee, and not on the gross amount invoiced by such Affiliate
or sublicensee to the End User; less the following deductions if and to the
extent they are included in the gross invoiced sales price of the Product or
otherwise directly incurred by LICENSEE, its Affiliates and their respective
sublicensees with respect to the sale of the Product: (a) rebates, quantity and
cash discounts, and other usual and customary discounts to customers; (b) taxes
and duties paid, absorbed or allowed which are directly related to the sale of
the Product; (c) credits, allowances, discounts and rebates to, and chargebacks
for spoiled, damaged, out-dated, rejected or returned Product; (d) actual
freight and insurance costs incurred in transporting the Product to customers,
provided that in no event shall deductions for freight and insurance exceed
three percent (3%) of the gross amount invoiced; (e) discounts or rebates or
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      Applicable Law, including any governmental special medical assistance
programs; (f) customs duties, surcharges and other governmental charges incurred
in connection with the exportation or importation of the Product;
(g) fee-for-service wholesaler fees and inventory management fees paid to
non-Affiliate wholesalers, including hospital buying group/group purchasing
organization administration fees, which are reasonably allocated to the Product,
to the extent consistent with the usual course of dealing of the Selling Party
for its products other than a Product; and (h) amounts that are written off as
uncollectible in accordance with the accounting procedures of the Selling Party,
consistently applied, to the extent a royalty has actually been paid to PFIZER
therefor, provided that LICENSEE has made reasonable efforts to collect on such
receivable, and provided, further, that if such receivable shall thereafter be
paid or otherwise satisfied, the amount thereof shall be added to Net Sales for
the Calendar Quarter in which so paid or satisfied. Subsections (a) through
(h) shall be collectively referred to as “Deductions”.

The following principles shall apply in the calculation of Net Sales:

  1.36.1.   In the case of any sale of a Product which is not invoiced or is
delivered before invoice, Net Sales shall be calculated at the time of shipment
or when the Product is paid for, if paid for before shipment or invoice.    
1.36.2.   In the case of any sale or other disposal of a Product for non-cash
consideration, Net Sales shall be calculated as the fair market price of the
Product in the country of sale or disposal. Notwithstanding the foregoing,
provision of the Product for the purpose of conducting pre-clinical or clinical
research or Development shall not be deemed to be a sale, so long as the Product
is provided at a price which does not exceed the reasonably estimated cost of
production and distribution thereof.     1.36.3.   In the event a Product is
sold as a Combination Product, the Net Sales of the Product, for the purposes of
determining royalty payments, shall be determined by multiplying the Net Sales
of the Combination Product by the fraction, A/(A+B) where A is the weighted (by
sales volume) average sale price in a particular country of the Product when
sold separately in finished form and B is the weighted average sale price in
that country of the other product(s) sold separately in finished form. In the
event that such average sale price cannot be determined for both the Product and
the other product(s) in combination, Net Sales for purposes of determining
royalty payments shall be agreed by the Parties based on the relative value
contributed by each component, such agreement not to be unreasonably withheld,
or, if not agreed, determined pursuant to Section 16.1.2.     1.36.4.   Unless
otherwise specified herein, Net Sales shall be calculated in accordance with
GAAP generally and consistently applied.

  1.37.   “Patent Rights” means (a) the patents and patent applications listed
in Schedule B, (b) all divisionals, continuations, and continuations-in-part
that claim priority to the patent applications described in subsection (a) or
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      the patents described in subsection (a) issued, (c) all patents that have
issued or in the future issue from any of the foregoing patent applications in
subsections (a) and (b), including utility, model and design patents and
certificates of invention, (d) any reissues, renewals, extensions or additions
of any of the foregoing, and (e) any foreign equivalents of any of the
foregoing.     1.38.   “Person” means an individual, corporation, partnership,
limited liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity not
specifically listed herein.     1.39.   “Phase II Clinical Trial” means a
clinical trial of a Product on patients (i) the principal purpose of which is to
make a preliminary determination that such Product is safe for its intended use,
(ii) which contains a primary efficacy endpoint pursuant to the protocol
established by LICENSEE and approved by the applicable Regulatory Authority, and
(iii) which is generally consistent with the description in 21 CFR §312.21(b)
(as hereafter modified or amended) and any of its foreign equivalents. For
clarity, such trial may be referred to and conducted as a “Phase IIB Trial” or a
“De-Risking Imaging Trial” so long as it satisfies all requirements under 21 CFR
§312.21(b).     1.40.   “Phase III Clinical Trial” means the first morbidity and
mortality clinical trial required for the filing of an NDA/BLA or equivalent
with a regulatory agency for a Product that is performed after collecting
preliminary evidence suggesting dose and effectiveness of such Product, and
which trial has safety and efficacy endpoints that, if met, are acceptable to
the applicable Regulatory Authorities as a basis for approval of such NDA/BLA,
and which is generally consistent with the description in 21 CFR §312.21(c) (as
hereafter modified or amended) and any of its foreign equivalents.     1.41.  
“Product” means, on a Compound-by-Compound basis, any product(s) in which such
Compound is used as an active ingredient, for any indication and through any
mode of administration, and any formulations and line extensions of such a
product.     1.42.   “Regulatory Approval” means, with respect to a Product in
any country or jurisdiction, any approval (including where required, pricing and
reimbursement approvals), registration, license or authorization that is
required by the applicable Regulatory Authority to market and sell such Product
in such country or jurisdiction.     1.43.   “Regulatory Authority” means any
governmental agency or authority responsible for granting Regulatory Approvals
for pharmaceutical or biological products, as applicable, in the Territory.    
1.44.   “Regulatory Filings” means, with respect to a Product, any submission to
a Regulatory Authority of any appropriate regulatory application, including any
IND, NDA/BLA, any submission to a regulatory advisory board, any marketing
authorization application, and any supplement or amendment thereto.

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  1.45.   “Royalty Term” means, on a Product-by-Product and country-by country
basis with respect to each Product and each country in the Territory, the period
commencing on the Effective Date and expiring upon the later of: (a) expiration
or abandonment or other termination of the last Valid Claim of the Patent Rights
Covering such Product in such country in the Territory, (b) the expiration of
any market exclusivity period granted by a Regulatory Authority for such Product
in such country, or (c) ten (10) years following the date of First Commercial
Sale of such Product in such country.     1.46.   “Sublicense Fees” has the
meaning as set forth in Section 5.1.4.     1.47.   “Territory” means all
countries of the world.     1.48.   “Third Party” means any Person other than a
Party or an Affiliate of a Party.     1.49.   “Trademarks” has the meaning as
set forth in Section 13.6.4.     1.50.   “United States” means the United States
of America, its possessions and territories.     1.51.   “Use” means to
research, Develop, make, have made, use, sell, have sold, offer for sale,
otherwise Commercialize and import.     1.52.   “Valid Claim” means either (a) a
claim of an issued and unexpired patent included within the Patent Rights, which
has not been permanently revoked or declared unenforceable or invalid by an
unreversed and unappealable or unreversed and unappealed decision of a court or
other appropriate body of competent jurisdiction, or (b) a claim of a pending
patent application included within the Patent Rights, which claim has not been
revoked, cancelled, withdrawn, or abandoned or finally disallowed without the
possibility of appeal or refiling of such application (or which is not appealed
or refiled within the time allowed for appeal).

2.   LICENSE GRANT

    2.1. License Grant.

2.1.1. Patent Rights. Subject to the terms and conditions of this Agreement,
PFIZER hereby grants to LICENSEE an exclusive (even as to PFIZER and its
Affiliates), sublicensable (subject to Section 2.2), transferable (in accordance
with Section 17.1), royalty-bearing right and license under the Patent Rights to
Use the Products in the Field within the Territory.
2.1.2. Know How. Subject to the terms and conditions of this Agreement, PFIZER
hereby grants to LICENSEE an exclusive (even as to PFIZER and its Affiliates),
sublicensable (subject to Section 2.2), transferable (in accordance with
Section 17.1), royalty-bearing right and license under the Know-How to Use the
Products in the Field within the Territory.
2.1.3. Danisco Agreement. On or before the Effective Date hereof, LICENSEE,
PFIZER and Danisco US, Inc. (“Danisco”) have executed a

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Partial Assignment, Amendment and Assumption of Agreement (the “Danisco
Agreement”) pursuant to which LICENSEE acquired from Danisco an exclusive
license under certain patents and patent applications (the “Danisco IP”) to
make, have made, import, use, market, offer for sale and sell LICENSED PRODUCTS
(as defined in the Danisco Agreement). If PFIZER fails to timely pay to Danisco
the consideration due to Danisco pursuant to Section 3 of the FIRST AMENDMENT
(as defined in the Danisco Agreement) and as described in Article 4.2 of the
LICENSE AGREEMENT (as defined in the Danisco Agreement), PFIZER shall promptly
notify LICENSEE thereof, and PFIZER and LICENSEE shall promptly and in good
faith, and at PFIZER’s sole cost and expense, seek to cure such failure to
timely pay Danisco, provided, however, that the good faith obligation to cure
such failure shall not require PFIZER to pay to Danisco any consideration in
addition to the amount agreed to in the FIRST AMENDMENT. Should PFIZER and
LICENSEE not succeed in curing such failure, LICENSEE may immediately terminate
this Agreement.

  2.2.   Sublicense Rights. Subject to Section 2.2.4 hereof, LICENSEE may
sublicense the rights granted to it by PFIZER under this Agreement to any of its
Affiliates or to any Third Party. Any and all sublicenses shall be subject to
the following requirements:

  2.2.1.   All sublicenses shall be subject to and consistent with the terms and
conditions of this Agreement and shall: (a) preclude the assignment of such
sublicense without the prior written approval of PFIZER, such approval not to be
unreasonably withheld, conditioned or delayed, and (b) preclude the granting of
further sublicenses in contravention of the terms and conditions of this
Agreement. In no event shall any sublicense relieve LICENSEE of any of its
obligations under this Agreement.     2.2.2.   LICENSEE shall furnish to PFIZER
a true and complete copy of each sublicense agreement and each amendment
thereto, within [**] days after the sublicense or amendment has been executed.  
  2.2.3.   At least [**] days before granting a sublicense to a Third Party in
any country in the Territory, LICENSEE shall provide PFIZER with written notice
of its interest in granting a sublicense, which notice shall specify the
country(ies) in which LICENSEE is interested in granted a sublicense. If PFIZER
notifies LICENSEE within such [**] day period that PFIZER desires to negotiate
an agreement with respect to such proposed sublicense rights, then LICENSEE
shall negotiate with PFIZER during such [**] day period, or such longer period
as agreed between the Parties, regarding the terms pursuant to which the Parties
would enter into such an agreement.     2.2.4.   Any sublicense granted by
LICENSEE to a Third Party in the United States, Japan, China or any country in
Europe, is subject to the prior written consent of PFIZER, such consent not to
be unreasonably withheld, conditioned or delayed.

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  2.3.   Residuals. PFIZER may use for any purpose the Residuals resulting from
PFIZER’s access to or work with the Products, but not for purposes of clinically
Developing, Commercializing or manufacturing for sale any Products in the Field
in the Territory. As used herein, “Residuals” means information in non-tangible
form which may be retained in the unaided memories of PFIZER’s employees who
have had access to the Products, including ideas, concepts, know-how or
techniques related thereto.     2.4.   365(n) Rights. All rights granted under
this Agreement by PFIZER are, for the purposes of Article 365(n) of the
Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Article 101 of the Bankruptcy Code. The Parties agree that LICENSEE will retain,
and may fully exercise, all of its rights and elections as a licensee under the
Bankruptcy Code.     2.5.   No Additional Rights. Nothing in this Agreement
shall be construed to confer any rights upon LICENSEE by implication, estoppel,
or otherwise as to any technology or Intellectual Property Rights of PFIZER or
its Affiliates other than the Licensed Technology, regardless of whether such
technology or Intellectual Property Rights shall be dominant or subordinate to
any Licensed Technology; provided, however, that this Section 2.5 shall not
supersede the provisions of Section 2.4 and the representations and warranties
given by PFIZER pursuant to Article 10. Nothing in this Agreement shall be
construed to confer any rights upon PFIZER by implication, estoppel, or
otherwise as to any technology or Intellectual Property Rights of LICENSEE or it
Affiliates other than as expressly provided in Section 13.6.4.

3.   TECHNOLOGY TRANSFER

  3.1.   Process.

3.1.1. Documentation. Beginning as promptly as reasonably practical after the
Effective Date and continuing for a period of [**] after the Effective Date
(“Transfer Period”), PFIZER will use reasonable efforts to transfer to LICENSEE
the non-clinical, clinical, pharm-sci, manufacturing and regulatory information
and tangible materials described on Schedule C that (a) exists as of the
Effective Date, (b) includes only information and data related to ETC-216
(provided, however, that, notwithstanding the foregoing, (i) PFIZER shall use
reasonable efforts to separate information and data specific to ETC-216 from
other information and data, and (ii) PFIZER shall provide to LICENSEE such
separated information and data, other information and data that primarily relate
to ETC-216, and the information and data that is reasonably necessary for
LICENSEE’s regulatory and patent activities hereunder), and (c) is reasonably
retrievable by PFIZER (collectively, “Documentation”), provided, however, that
no Documentation containing protected health information or other patient
information, or specimens collected from patients, will be transferred unless
PFIZER has obtained prior informed written consent to such transfer. To the
extent the Documentation exists as of the Effective Date in an electronic
format, including scanned versions of a hardcopy, PFIZER will provide to
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Documentation which does not exist in electronic format as of the Effective
Date, PFIZER will provide to LICENSEE a physical copy of the Documentation. For
a period of [**] following expiration of the Transfer Period, if PFIZER or
LICENSEE discovers or learns of any other Documentation that exists and has not
been supplied to LICENSEE in accordance with this Section 3.1.1, LICENSEE shall
provide PFIZER with written notice thereof, including a reasonably detailed
description thereof, and PFIZER shall use reasonable efforts to promptly locate
such Documentation and provide a copy of same to LICENSEE. Notwithstanding the
foregoing, but subject to clause (b)(ii) above and, with respect to clause (x)
below, subject to clause (b)(i) above, PFIZER will not provide Documentation
that: (x) contains data or records related to technology or products other than
ETC-216, or (y) includes laboratory notebooks, PFIZER internal team meeting
minutes, communications, personal notes or internal correspondence. For the
avoidance of doubt, PFIZER has the right, but not the obligation, to retain
copies of Documentation that are provided to LICENSEE.
3.1.2. Manufacturing Technology. Beginning as promptly as reasonably practical
after the Effective Date and continuing for a period of [**] following the
Effective Date, PFIZER shall cooperate with and provide reasonable assistance to
LICENSEE or its designee, through consultation and face-to-face meetings, to
enable LICENSEE or its designee in an efficient and timely manner to transfer
the Know-How with respect to the manufacturing and formulation of ETC-216
generated by or on behalf of PFIZER. PFIZER’s engagement pursuant to this
Section 3.1.2 shall be limited to a maximum of [**] person-hours. LICENSEE shall
reimburse PFIZER for all reasonable, documented out-of-pockets costs and
expenses (but not PFIZER’s internal costs) incurred in connection therewith.
3.1.3. Regulatory Filings; Regulatory Approvals. PFIZER will transfer to
LICENSEE all Regulatory Filings and Regulatory Approvals held by PFIZER or its
Affiliates with respect to ETC-216, and will reasonably cooperate with LICENSEE
in notifying each applicable Regulatory Authority of such transfer. PFIZER shall
promptly initiate such transfers after the Effective Date and shall complete
such transfers within [**] after the Effective Date; provided, however, that,
PFIZER shall initiate the transfer of any INDs to LICENSEE, and notify the FDA
and all other relevant Regulatory Authorities thereof, within [**] days after
the Effective Date. Without limiting the foregoing, PFIZER shall be available to
consult with LICENSEE on regulatory matters related to ETC-216, including with
respect to manufacturing data submitted to the FDA and other Regulatory
Authorities. PFIZER’s engagement pursuant to this Section 3.1.3 shall be limited
to a maximum of [**] person-hours total. LICENSEE shall reimburse PFIZER for all
reasonable documented out-of-pockets costs and expenses (but not PFIZER’s
internal costs) incurred in connection therewith.
3.1.4. Transition Liaison. Each Party shall appoint one of its employees to
serve as a transition liaison to oversee and facilitate the transfer and
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Filings and Regulatory Approvals pursuant to Sections 3.1.1, 3.1.2 and 3.1.3.
PFIZER’s initial transition liaison is [**], and LICENSEE’s initial transition
liaison is [**]. Each Party may replace its transition liaison upon written
notice to the other Party.

4.   DEVELOPMENT AND COMMERCIALIZATION

  4.1.   Development. LICENSEE shall itself, or through its Affiliates or
sublicensees, use Commercially Reasonable Efforts to Develop at least one
Product in the Territory. In connection with its efforts to Develop Products,
LICENSEE shall bear all responsibility and expense for filing Regulatory Filings
in LICENSEE’s name and obtaining Regulatory Approval for such Products. LICENSEE
will undertake such activities at its sole expense and shall provide to PFIZER
reports regarding LICENSEE’s progress within [**] days following the expiration
of each Calendar Year. For clarity, the first such report shall pertain to
LICENSEE’s efforts during the 2010 Calendar Year.     4.2.   Commercialization.
With respect to each Product for which LICENSEE obtains Regulatory Approval,
LICENSEE shall itself, or through its Affiliates or sublicensees, use
Commercially Reasonable Efforts to Commercialize such Product in the Territory
following receipt of Regulatory Approval for such Product in the relevant
country in the Territory. LICENSEE will undertake such activities at its sole
expense.     4.3.   Manufacturing. As between the Parties, LICENSEE shall have
the sole right to manufacture, or have manufactured, the Products, and LICENSEE,
its Affiliates and sublicensees, shall be entitled to use the manufacturing
rights under the Licensed Technology, and the rights granted under the Danisco
Agreement, for such purposes.

5.   PAYMENT TERMS

  5.1.   Payment Terms.

5.1.1. Upfront Payment. As consideration for PFIZER’s grant of an exclusive
license under the Licensed Technology, LICENSEE shall pay to PFIZER a one-time
upfront, non-refundable and non-creditable payment of US$10,000,000 within five
(5) Business Days after the Effective Date.
5.1.2. Milestone Payments. LICENSEE shall notify PFIZER as soon as practicable
upon achievement of each Milestone. LICENSEE shall pay to PFIZER the following
one-time milestone payments (each, a “Milestone Payment”) within (a) [**] days
after the relevant Clinical or Regulatory Milestone is achieved and (b) [**]
days after the relevant Commercial Milestone is achieved:

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      CLINICAL MILESTONES   PAYMENT
(1) upon Commencement of first Phase II Clinical Trial of a Product conducted by
LICENSEE, its Affiliates or its or their permitted sublicensees
  US$[**]
 
   
(2) upon Commencement of the first Phase III Clinical Trial of a Product
conducted by LICENSEE, its Affiliates or its or their permitted sublicensees
  US$[**]
 
   
REGULATORY MILESTONES
  PAYMENT
(1) upon first acceptance by the FDA of the filing of a NDA/BLA for a Product
  US$[**]
 
   
(2) upon first acceptance by the EMEA of the filing of an MAA for a Product via
the centralized procedure pursuant to Directive 93/41/EEC
  US$[**]
 
   
(3) upon first acceptance by the Pharmaceuticals and Medical Devices Agency
(“PMDA”) of the filing of a manufacturing/distribution approval application for
a Product in Japan
  US$[**]
 
   
COMMERCIAL MILESTONES
  PAYMENT
(1) upon receipt by LICENSEE, its Affiliates or its or their sublicensee(s) of
the first Regulatory Approval by the FDA for a Product
  US$[**]
 
   
(2) upon receipt by LICENSEE, its Affiliates or its or their sublicensee(s) of
the first Regulatory Approval by the EMEA for a Product, including pricing and
reimbursement approval with the applicable Regulatory Authorities in three Major
European Countries
  US$[**]
 
   
(3) upon receipt by LICENSEE, its Affiliates or its or their sublicensee(s) of
the first Regulatory Approval by the PMDA of a manufacturing/distribution
approval application for a Product, including pricing and reimbursement approval
  US$[**]
 
   
(4) upon achieving aggregate Net Sales of Products in any Calendar Year equal to
or greater than [**] US dollars (US$[**])
  US$[**]

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      COMMERCIAL MILESTONES   PAYMENT
(5) upon achieving aggregate Net Sales of Products in any Calendar Year equal to
or greater than [**] US dollars (US$[**])
  US$[**]
 
   
(6) upon achieving aggregate Net Sales of Products in any Calendar Year equal to
or greater than [**] US dollars (US$[**])
  US$[**]

Each Milestone Payment shall be deemed earned as of the first achievement of the
corresponding Milestone event. For the avoidance of doubt, regardless of the
number of Products that achieve a Milestone: (i) each Milestone Payment shall be
payable only on the first occurrence of the Milestone; (ii) none of the
Milestone Payments shall be payable more than once; (iii) no additional
Milestone Payments shall be due for Milestones completed for the Development and
Commercialization of a Product for any additional indications or for additional
Products; and (iv) satisfaction of a Milestone by a sublicensee or assignee of,
or Third Party retained by, LICENSEE or its Affiliates shall be deemed to have
been satisfied by LICENSEE. The total maximum amount of Milestone Payments that
may be paid by or on behalf of LICENSEE under this Agreement is four hundred ten
million US dollars (US$410,000,000).
               5.1.3. Royalty Payments.

  (a)   Royalties. In consideration of the licenses and rights granted to
LICENSEE hereunder, on a Product-by-Product and country-by-country basis,
LICENSEE will pay to PFIZER, subject to subsection (b) of this Section 5.1.3,
royalties on Net Sales of a Product in the Territory, where such royalties shall
be calculated each Calendar Quarter by multiplying the Net Sales for such
Calendar Quarter by [**] percent ([**]%); provided, however, that, if no Valid
Claim Covers the Use of a Product in the U.S. or Japan, the royalty rate for
such Product in such country shall be reduced to [**] percent ([**]%)
(collectively, the “Royalties”). LICENSEE’s obligation to pay Royalties shall
commence on the date of the First Commercial Sale of the Product in a country
and end at the end of the applicable Royalty Term, on a Product-by-Product and
country-by-country basis. LICENSEE shall pay all such payments within [**] days
following the expiration of each Calendar Quarter. All payments shall be
accompanied by a report that includes reasonably detailed information regarding
a total sales calculation of Net Sales of Products (including all Deductions)
and all Royalties payable to PFIZER for the applicable Calendar Quarter
(including any foreign exchange rates employed).     (b)   Generic Competition.
In the event of bona fide commercial sales activities in any country in the
Territory undertaken by any Third Party (other than pursuant to a sublicense
from LICENSEE) with respect to (i) any product approved or to be approved for
sale in such country using a Product as its reference product, or (ii) any other
product specifically intended as a direct

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      generically substitutable product to a Product in such country
(collectively, a “Generic Product” with respect to such Product), and in each
case ((i) and (ii)) (1) after such Generic Product in such country has obtained
a market share greater than [**] percent ([**]%) of the total market share for
such Product and such Generic Product, as measured by unit sales, and (2) for as
long as such commercial sales activity is undertaken in such country, the
royalty rate payable with respect to such Product in such country shall be [**]
percent ([**]%) of the applicable royalty rate pursuant to Section 5.1.3(a).    
(c)   Royalty Term. Royalties will be payable on a Product-by-Product and
country-by-country basis commencing as of the First Commercial Sale of the
relevant Product in the relevant country until the expiration of the Royalty
Term for such Product in such country. Upon expiration of the Royalty Term with
respect to a Product and a country, the licenses granted to LICENSEE under this
Agreement shall convert to perpetual, exclusive, fully paid-up,
non-royalty-bearing licenses with respect to such Product in such country.

5.1.4. Sublicense Fees. In further consideration of the licenses and rights
granted to LICENSEE hereunder, LICENSEE will pay to PFIZER [**] percent ([**]%)
of the Sublicense Fees. “Sublicense Fees” means all consideration received by
LICENSEE or its Affiliates with respect to the granting of a sublicense under
any Intellectual Property Right licensed to LICENSEE hereunder, including any
up-front payments, milestone payments, or equity in the sublicensee entity
received for granting such sublicense, but excluding any amounts received by
LICENSEE or its Affiliates in respect of (a) research funding for the
development of a Product, (b) direct pass-through costs, (c) in exchange for
services priced at fair market value, provided in connection with such
sublicensee’s Use of a Product, (d) equity participation in the LICENSEE or its
Affiliates at fair market value (which may, for the avoidance of doubt, include
a premium above the publicly quoted price), or (e) amounts received by LICENSEE
on sales by its sublicensee for which Royalties are actually paid or payable to
PFIZER pursuant to Section 5.1.3 hereof, in each case ((a) through (c)) to the
extent such amounts, if marked up above actual costs or at a premium above the
publicly quoted price (in the case of equity participation), are reasonable and
bona fide payments in respect of the item concerned consistent with industry
standards. LICENSEE shall pay all Sublicense Fees received during each Calendar
Quarter within [**] days following the expiration of each such Calendar Quarter.
All payments shall be accompanied by a report that includes a calculation of all
Sublicense Fees payable to PFIZER for the applicable Calendar Quarter.
5.1.5. Other Payments. LICENSEE shall pay to PFIZER any other amounts due under
this Agreement within [**] days following receipt of a proper invoice.

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5.1.6. Late Payments. Any late payments shall bear interest, to the extent
permitted by law, at [**] percentage points above the Prime Rate of interest as
reported in the Wall Street Journal on the date payment is due.
     5.2. Payment Method.
5.2.1. Any payments under Section 5 that are recorded in currencies other than
the US dollar shall be converted into US dollars at the average of the daily
foreign exchange rates published in the Wall Street Journal (or any other
qualified source that is acceptable to both Parties) for the Calendar Quarter in
which such payments or expenses occurred, or for periods less than a Calendar
Quarter, the average of the daily rates published in the Wall Street Journal for
such period.
5.2.2. All payments from LICENSEE to PFIZER shall be made by wire transfer in US
Dollars to the credit of such bank account as may be designated by PFIZER in
writing to LICENSEE. Any payment which falls due on a date which is not a
Business Day may be made on the next succeeding Business Day.
5.2.3. If, by reason of Applicable Law in any country, it becomes impossible or
illegal for LICENSEE, its Affiliate or sublicensee to make royalty or other
payments due hereunder to PFIZER in US Dollars, or to make royalty or other
payments due hereunder to PFIZER, (i) if permitted by Applicable Law, such
royalties or other payments due hereunder shall be deposited in local currency
in the relevant country to the credit of PFIZER in a recognized banking
institution designated by PFIZER or, if none is designated by PFIZER within [**]
days, in a recognized banking institution selected by LICENSEE, its Affiliate or
sublicensee, as the case may be, and identified in a notice in writing given to
PFIZER, and (ii) if not permitted under Applicable Law, the payment of such
royalties or other payments shall be negotiated promptly and in good faith by
the Parties.
     5.3. Taxes.
5.3.1. It is understood and agreed between the Parties that any and all
applicable sales, use, VAT, GST, excise, property, and other similar
taxes(collectively, “Taxes”) shall be paid by the Party that such Tax is imposed
upon under Applicable Law; provided that if Applicable Law requires PFIZER to
collect any such Taxes imposed upon LICENSEE, the amount of such Taxes shall be
added to the payment to be made by LICENSEE to PFIZER. PFIZER shall remit such
Taxes collected by PFIZER to the appropriate taxing jurisdiction. Each Party
will be responsible for their own income and property taxes.
5.3.2. If LICENSEE is required to make a payment to PFIZER subject to a
deduction of tax or withholding tax (a “Withholding Tax”), (a) LICENSEE shall
deduct and withhold the amount of such Withholding Taxes for the account of
PFIZER to the extent required by Applicable Law, (b) the amounts

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payable to PFIZER shall be reduced by the amount of such Withholding Taxes
deducted and withheld, (c) LICENSEE shall pay the amounts of such Withholding
Taxes to the proper governmental authority in a timely manner and (d) LICENSEE
shall promptly transmit to PFIZER an official tax certificate or other evidence
of such tax obligations, together with proof of payment from the relevant
governmental authority of all amounts deducted and withheld, sufficient to
enable PFIZER to claim a credit or deduction for such payment of such
Withholding Taxes. Any such Withholding Taxes required under Applicable Law to
be paid or withheld shall be an expense of, and borne solely by, PFIZER.
LICENSEE will provide PFIZER with reasonable assistance, at PFIZER’s expense, to
enable PFIZER to reduce the amount of such Withholding Taxes or recover such
Withholding Taxes as permitted by Applicable Law.
5.3.3. Notwithstanding anything in this Agreement to the contrary, if an action
by LICENSEE, including an assignment by LICENSEE of its rights or obligations
under this Agreement, or any failure on the part of LICENSEE or its Affiliates
to comply with applicable laws or filing or record retention requirements, leads
to the imposition of withholding tax liability on the amounts payable hereunder
by LICENSEE to Pfizer that would not have been imposed in the absence of such
action or in an increase in such liability above the liability that would have
been imposed in the absence of such action, LICENSEE shall indemnify and hold
harmless Pfizer (or its assignee) from any such additional or increased tax
liability. In the event of any such action, LICENSEE shall, or shall cause its
assignee to, gross up any payments it makes to Pfizer to the extent necessary so
that the net payment received by Pfizer after such additional or increased tax
liability equals the amount that would have been received by PFIZER under this
Agreement had the LICENSEE not taken such action.
6. RECORDS; AUDIT RIGHTS
     6.1. Relevant Records.
6.1.1. Relevant Records. LICENSEE shall, and shall cause its Affiliates and
sublicensees to, maintain accurate financial books and records pertaining to the
sublicensing of the Licensed Technology pursuant to Section 2.2, LICENSEE’s
prosecution, maintenance and enforcement of the Patent Rights pursuant to
Section 7, and the sale of the Products, including any and all calculations of
the applicable Net Sales and Sublicense Fees, and the occurrence of the
Milestones (collectively, “Relevant Records”). The Relevant Records shall be
maintained for the longer of: (a) the period of time required by Applicable Law,
or (b) [**] years following the date on which the relevant amounts were received
or incurred.
6.1.2. Audit Request. PFIZER shall have the right during the term and for [**]
months thereafter to engage, at its own expense, an independent auditor
reasonably acceptable to LICENSEE to examine the Relevant Records from

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time-to-time, but no more frequently than [**] every [**] months, as may be
necessary to verify compliance with the terms of this Agreement. Such audit
shall be requested in writing at least [**] days in advance, and shall be
conducted during LICENSEE’s normal business hours and otherwise in manner that
minimizes any interference to LICENSEE’s business operations. No period shall be
subject to audit more than [**], except that PFIZER may conduct one additional
audit for each audit of a preceding period which has revealed an underpayment by
LICENSEE of more than five percent (5%) of the amount due PFIZER for such
preceding period. The auditor shall enter into a reasonable confidentiality
agreement with LICENSEE and shall only be permitted to disclose to PFIZER
information relating to LICENSEE’s compliance with its payment obligations
hereunder.
6.1.3. Audit Fees and Expenses. PFIZER shall bear any and all fees and expenses
it may incur in connection with any such audit of the Relevant Records;
provided, however, in the event an audit reveals an underpayment of LICENSEE of
more than five percent (5%) as to the period subject to the audit, LICENSEE
shall reimburse PFIZER for any reasonable and documented out-of-pocket costs and
expenses of the audit within [**] days after receiving invoices thereof.
6.1.4. Payment of Deficiency. If any audit establishes that LICENSEE underpaid
any amounts due to PFIZER under this Agreement, then LICENSEE shall pay PFIZER
any such deficiency within [**] days after the later of the receipt of written
notice thereof and the resolution of any disputes related thereto. For the
avoidance of doubt, such payment will be considered a late payment, subject to
Section 5.1.6. If any audit establishes that LICENSEE overpaid any amounts due
to PFIZER, PFIZER shall pay LICENSEE any such overpayment within [**] days after
the later of the receipt of written notice thereof and the resolution of any
disputes related thereto, without interest.
7. INTELLECTUAL PROPERTY RIGHTS

  7.1.   Pre-existing IP. Subject to the rights and licenses expressly granted
under this Agreement, each Party shall retain all rights, title and interests in
and to any Intellectual Property Rights that are owned, licensed or sublicensed
by such Party prior to or independent of this Agreement.     7.2.   Patent
Prosecution.

  (a)   Patent Prosecution and Maintenance. Subject to PFIZER’s rights set forth
in Section 7.2(c) below, LICENSEE will be responsible for filing, prosecuting
(including in connection with any reexaminations, oppositions and the like) and
maintaining the Patent Rights in the Territory and in PFIZER’s name, at
LICENSEE’s own cost and expense, using reasonable efforts with respect thereto.
LICENSEE will select qualified outside patent counsel and corresponding foreign
associates to prepare, file, prosecute and maintain the Patent Rights. Before
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      LICENSEE will provide PFIZER a reasonable opportunity to review and
comment on proposed submissions to any patent office and reasonably consider any
timely comments provided by PFIZER to LICENSEE. LICENSEE will keep PFIZER
reasonably informed of the status of the Patent Rights by timely providing
PFIZER copies of significant communications relating to such Patent Rights that
are received from any patent office or patent counsel of record or foreign
associate.     (b)   Assistance.

  (i)   PFIZER will provide reasonable assistance to LICENSEE, at LICENSEE’s
expense, in connection with the filing, prosecution and maintenance of such
Patent Rights, where such assistance shall include providing access to relevant
persons and executing all documentation reasonably requested by LICENSEE.
Promptly after the Effective Date, PFIZER will provide to LICENSEE a list of all
Patent Rights, the applicable file wrappers for such Patent Rights and any
docket reports and status reports with respect to such Patent Rights.     (ii)  
As reasonably requested by LICENSEE in writing, PFIZER shall cooperate, at
LICENSEE’s expense, in obtaining patent term restoration (under, but not limited
to, the Drug Price Competition and Patent Term Restoration Act), supplementary
protection certificates or their equivalents, and patent term extensions with
respect to the Patent Rights in the United States, Europe and any other country
in which any patent term restorations, supplementary protection certificates,
patent term extensions or their equivalents are available.

  (c)   Failure to Prosecute or Maintain. In the event LICENSEE elects to forgo
filing, prosecution or maintenance of the Patent Rights, LICENSEE shall notify
PFIZER of such election at least [**] days prior to any filing or payment due
date, or any other due date that requires action (“Election Notice”). Upon
receipt of an Election Notice in accordance with the foregoing, PFIZER shall be
entitled, upon written notice to LICENSEE, at its sole discretion and expense,
to file or to continue the prosecution or maintenance of such Patent Right in
such country in PFIZER’s name using counsel of its own choice and at its own
expense (“Pfizer Patent Rights”), in which case, the term “Patent Rights” shall
automatically be modified to exclude such Pfizer Patent Rights as of the date
LICENSEE provides PFIZER such Election Notice.

8. INFRINGEMENT; MISAPPROPRIATION

  8.1.   Notification. Each Party will promptly notify the other Party in
writing of any actual or threatened infringement, misappropriation or other
violation by a Third

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      Party of any Licensed Technology in the Field and in the Territory of
which it becomes aware (“Third Party Infringement”).

     8.2. Infringement Action.
8.2.1. Right of First Enforcement.

  (a)   LICENSEE shall have the first right (but not the obligation), at its own
expense, to control enforcement of the Licensed Technology against any Third
Party Infringement and may name PFIZER as a party for standing purposes. Prior
to commencing any such action (unless delay would result in the loss of rights),
LICENSEE shall consult with PFIZER and shall consider PFIZER’s recommendations
regarding the proposed action. LICENSEE shall give PFIZER timely notice of any
proposed settlement of any such action instituted by LICENSEE and shall not,
without the prior written consent of PFIZER (not to be unreasonably withheld),
enter into any settlement that would: (i) adversely affect the validity,
enforceability or scope of any of the Patent Rights, (ii) give rise to liability
of PFIZER or its Affiliates, (iii) admit non-infringement of any Patent Rights,
or (iv) otherwise impair PFIZER’s rights in any Licensed Technology or this
Agreement.     (b)   Subject to subsection (c) hereof, if LICENSEE does not
obtain agreement from the alleged infringer to desist or fails to initiate an
infringement action: (i) within [**] days following LICENSEE’s receipt of notice
of the alleged infringement, or (ii) no later than [**] days before the
expiration date for filing such action, whichever comes first, PFIZER shall have
the right, at its sole discretion, to control such enforcement of the Licensed
Technology at its sole expense.     (c)   In the case of a Paragraph IV
Certification, the deadline for LICENSEE to file an action before PFIZER can
exercise the enforcements right in subsection (b) hereof is [**] days before the
expiration date for filing such action, unless LICENSEE has notified PFIZER in
writing at least [**] days before the expiration date for filing such action
that LICENSEE does not intend to file an action with respect to such
Paragraph IV Certification. “Paragraph IV Certification” means any certification
filed pursuant to 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV), or any
notice under any future analogous provisions of U.S. law applicable to biologics
(or any amendment or successor statute thereto), or any comparable law under any
other jurisdiction.

8.2.2. Assistance. At the request and sole cost and expense of the Party
controlling a Third Party Infringement, the other Party and its Affiliates shall
provide reasonable assistance in connection therewith (including by joining any
such action). The non-controlling Party shall have the right, at its own
expense, to be represented in any such action in which it is a party by
independent counsel of its own choice.

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  8.2.3.   Recoveries.

  (a)   Any recoveries resulting from an action relating to a claim of Third
Party Infringement shall first be applied against payment of the non-prosecuting
Party’s costs and expenses incurred in connection therewith, and then be applied
against payment of the prosecuting Party’s costs and expenses.     (b)   For any
action instituted by LICENSEE under 8.2.1(a), any remaining recoveries shall be
retained by (or if received by PFIZER, paid to) LICENSEE; provided however,
PFIZER shall be entitled to a Royalty on such remaining recoveries in accordance
with Section 5.1.3 as if the amount of such remaining recoveries were Net Sales
of LICENSEE in the Calendar Year in which the recoveries were received by
LICENSEE; provided, however, that, if LICENSEE fails to institute an action or
proceeding and PFIZER exercise its right to prosecute such infringement pursuant
to Section 8.2.1(b), any remaining recoveries shall be retained by (or if
received by LICENSEE, paid to) PFIZER.

9. CONFIDENTIALITY

  9.1.   Definition. “Confidential Information” means the terms and provisions
of this Agreement (for which each Party shall be deemed to be the disclosing
Party, notwithstanding Section 9.3.1) and other proprietary information and data
of a financial, commercial, medical, scientific or technical nature that the
disclosing Party or any of its Affiliates has supplied or otherwise made
available to the other Party or its Affiliates, which are: (a) disclosed in
writing or (b) if disclosed in a form other than in writing, then declared to be
confidential at the time of disclosure, and summarized in writing and provided
to the receiving Party within [**] days after disclosure. Notwithstanding the
foregoing and Section 9.3.1, all Know-How shall be considered LICENSEE’s and
PFIZER’s Confidential Information, provided, however, that Know-How not solely
applicable to the Use of ETC-216 shall be considered the Confidential
Information of PFIZER.     9.2.   Obligations. The receiving Party will protect
all Confidential Information of the disclosing Party against unauthorized
disclosure to Third Parties with the same degree of care as the receiving Party
uses for its own similar information, but in no event less than a reasonable
degree of care. The receiving Party may disclose the Confidential Information of
the disclosing Party to its Affiliates, and their respective actual and bona
fide potential directors, officers, employees, subcontractors, sublicensees,
consultants, attorneys, accountants, banks, lenders, acquirors and investors
(collectively, “Recipients”) who have a need-to-know such information (a) for
purposes related to this Agreement; (b) in connection with a potential merger,
acquisition or reorganization; or (c) as a part of due diligence investigations
related to the receiving Party, provided that the receiving Party shall hold
such Recipients to written obligations of confidentiality with terms and
conditions at least as restrictive as those set forth in this Agreement, and
provided, further, that LICENSEE may not disclose any Know-How relating to the
manufacturing of ETC-216 pursuant to subclauses (b) and (c) hereof, except to a
Recipient (A) with whom LICENSEE has

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      executed a non-binding term sheet and with whom LICENSEE expects in good
faith to consummate a transaction, or (B) with whom LICENSEE has executed a
binding agreement. The receiving Party shall only use the disclosing Party’s
Confidential Information to fulfill its obligations and exercise its rights
under this Agreement.     9.3.   Exceptions.

9.3.1. The obligations under this Section 9 shall not apply to any information
to the extent the receiving Party can demonstrate by competent evidence that
such information:

  (a)   is (at the time of disclosure) or becomes (after the time of disclosure)
known to the public or part of the public domain through no breach of this
Agreement by the receiving Party or any Recipients to whom it disclosed such
information;     (b)   was known to, or was otherwise in the possession of, the
receiving Party prior to the time of disclosure by the disclosing Party;     (c)
  is disclosed to the receiving Party on a non-confidential basis by a Third
Party who is entitled to disclose it without breaching any confidentiality
obligation to the disclosing Party; or     (d)   is independently developed by
or on behalf of the receiving Party or any of its Affiliates, as evidenced by
its written records, without use or access to the Confidential Information.

9.3.2. The restrictions set forth in this Section 9 shall not apply to any of
the disclosing Party’s Confidential Information that the receiving Party is
required to disclose under Applicable Laws, pursuant to a court order or other
governmental order or request, or that is necessary to disclose to defend or
prosecute litigation relating to the Products or this Agreement, provided that
the receiving Party: (a) provides the disclosing Party with prompt notice of
such disclosure requirement if legally permitted, (b) if legally permitted,
affords the disclosing Party an opportunity to oppose or limit, or secure
confidential treatment for, such required disclosure, and (c) if the disclosing
Party is unsuccessful in its efforts pursuant to subsection (b), discloses only
that portion of the disclosing Party’s Confidential Information that the
receiving Party is legally required to disclose as advised by the receiving
Party’s legal counsel.
9.3.3. A receiving Party may use and disclose Confidential Information of the
disclosing Party in order to seek or obtain patent rights or to Regulatory
Authorities in order to seek or obtain approval to conduct clinical trials or to
gain or maintain Regulatory Approval with respect to a Product; provided, that
such disclosure may be made only to the extent reasonably necessary to seek or
obtain such patent rights or approvals.

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9.3.4. In the event that PFIZER wishes to assign, pledge or otherwise transfer
its rights to receive some or all of the Milestone Payments and Royalties
payable hereunder, PFIZER may disclose to a Third Party Confidential Information
of LICENSEE in connection with, and which is directly relevant to, any such
proposed assignment, provided that PFIZER shall hold such Third Parties to
written obligations of confidentiality with terms and conditions at least as
restrictive as those set forth in this Agreement.
9.3.5. Upon execution of this Agreement, the Parties shall jointly issue a press
release announcing the execution of this Agreement, substantially in the form of
Schedule D. Thereafter, LICENSEE may issue press releases with respect to this
Agreement and the activities and results hereunder consistent with its own
internal policies, provided, however, that LICENSEE shall not issue any press
release that names PFIZER or any of its Affiliates without PFIZER’s prior
written consent, which cannot be unreasonably withheld or delayed, or unless in
accordance with Section 9.3.6, mutatis mutandis.
9.3.6. Each Party may disclose the terms of this Agreement to the extent such
Party is advised by counsel that such disclosure is required by Applicable Law
(including by rules or regulations of the United States Securities and Exchange
Commission (“SEC”), any other relevant securities commission in any country, any
securities exchange or NASDAQ); provided, that, (a) prior to such disclosure, to
the extent permitted by Applicable Law or such rules or regulations, the
disclosing Party promptly notifies the other Party of such requirement and the
disclosing Party furnishes only those terms of this Agreement that the
disclosing Party is legally required to furnish, and (b) specifically with
respect to a filing of this Agreement pursuant to the rules or regulations of
the SEC, any other securities commission, any securities exchange or NASDAQ, the
disclosing Party shall request, and use commercially reasonable efforts to
obtain, confidential treatment of terms permitted to be redacted from the forms
of such agreements so filed under the applicable rules and regulations of the
SEC, such securities commission, any securities exchange or NASDAQ, as
applicable. Each Party shall give the other Party a reasonable opportunity to
review those portions of all filings with the SEC (or any other relevant
securities commission in any country, any securities exchange or NASDAQ)
describing the terms of this Agreement (including any filings of this Agreement)
prior to submission of such filings, and shall give due consideration to any
reasonable and timely comments by the non-filing Party relating to such filing,
including the provisions of this Agreement for which confidential treatment
should be sought; provided that each Party will ultimately retain control over
what information that Party discloses to their relevant securities commission or
exchange.
9.3.7. Subject to entering into customary agreements of confidentiality with
each Brewer/Matin Party, LICENSEE may disclose to any Brewer/Matin Party (a) a
copy of this Agreement in which the milestone payment amounts, royalty rates,
Sublicense Fee rate, the schedules hereto, and any other information which
LICENSEE elects to redact, have been redacted, (b) any amendment or

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termination of this Agreement (except to the extent that any such amendment
affects the milestone payment amounts, royalty rates, Sublicense Fee rate or the
schedules hereto), (c) each report LICENSEE provides to PFIZER pursuant to the
third sentence of Section 4.1 of this Agreement, (d) the royalty reports
provided hereunder (with any information relating to the calculation of
Royalties payable to PFIZER and any other information not directly related to
the calculation of Net Sales redacted therefrom in LICENSEE’s discretion), (e)
any audit requests delivered to LICENSEE by PFIZER and any audit reports
provided to PFIZER (with any information relating to the calculation of
Royalties payable to PFIZER and any other information not directly related to
the calculation of Net Sales redacted from such audit requests and audit reports
in LICENSEE’s discretion), in each case pursuant to this Agreement, and (f) that
Section 5.1.3 of this Agreement has become operative, or ceased to be operative,
with respect to any Product in any country in the Territory. LICENSEE may
disclose to the attorney for the Brewer/Matin Parties an unredacted copy of this
Agreement solely for purposes of confirming the extent of such redactions.
“Brewer/Matin Party” means each of (i) Washington Cardiovascular Associates,
LLC, a Maryland limited liability company, (ii) HDLT LLC, a Delaware limited
liability company, (iii) H. Bryan Brewer (iv) Silvia Santamarina-Fojo,
(v) Michael Matin, and (vi) any successor, assign or heir of the foregoing.

  9.4.   Right to Injunctive Relief. The Parties agree that breaches of this
Section 9 may cause irreparable harm to the non-breaching Party and shall
entitle the non-breaching Party, in addition to any other remedies available to
it (subject to the terms of this Agreement), the right to seek injunctive relief
enjoining such action.     9.5.   Ongoing Obligation for Confidentiality. Upon
expiration or termination of this Agreement, the receiving Party shall, and
shall cause its Recipients to, destroy or return (as requested by the disclosing
Party) any Confidential Information of the disclosing Party, except for one copy
which may be retained in its confidential files for archive purposes.

10.   REPRESENTATIONS, WARRANTIES AND COVENANTS

  10.1.   Representations and Warranties by Each Party. Each Party represents
and warrants to the other Party as of the Effective Date that:

  (a)   it is a corporation duly organized, validly existing, and in good
standing under the laws of its jurisdiction of formation;     (b)   it has full
corporate power and authority to execute, deliver, and perform this Agreement,
and has taken all corporate action required by Applicable Law and its
organizational documents to authorize the execution and delivery of this
Agreement and the consummation of the transactions contemplated by this
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  (c)   this Agreement constitutes a valid and binding agreement enforceable
against it in accordance with its terms (except as the enforceability thereof
may be limited by bankruptcy, bank moratorium or similar laws affecting
creditors’ rights generally and laws restricting the availability of equitable
remedies and may be subject to general principles of equity whether or not such
enforceability is considered in a proceeding at law or in equity);     (d)   all
consents, approvals and authorizations from all governmental authorities or
other Third Parties required to be obtained by such Party in connection with the
execution and delivery of this Agreement have been obtained; and     (e)   the
execution and delivery of this Agreement and all other instruments and documents
required to be executed pursuant to this Agreement, and the consummation of the
transactions contemplated hereby do not and shall not: (i) conflict with or
result in a breach of any provision of its organizational documents, (ii) result
in a breach of any agreement to which it is a party that would impair the
performance of its obligations hereunder; or (iii) violate any Applicable Law.

  10.2.   Representations and Warranties by PFIZER. Subject to any intellectual
property rights owned by Danisco and licensed to LICENSEE pursuant to the
Danisco Agreement (of which PFIZER makes no representations or warranties),
PFIZER represents and warrants to LICENSEE as of the Effective Date that:

  10.2.1.   to the Knowledge of PFIZER, the Use of ETC-216 in the Field does not
infringe any Intellectual Property Rights of any Third Party;     10.2.2.   the
Know-How and Patent Rights (except as noted with respect to the Patent Rights on
Schedule B2) comprise all patents, patent applications and know-how owned or
Controlled by PFIZER or its Affiliates that are necessary or optimal for
LICENSEE to Use ETC-216;     10.2.3.   to its Knowledge, there is no claim
pending or threatened against PFIZER or its Affiliates alleging that the Use of
ETC-216 in the Field within the Territory infringes, misappropriates or
otherwise violates the Intellectual Property Rights of a Third Party;    
10.2.4.   to its Knowledge, PFIZER has not received written notice from a Third
Party asserting or alleging that the Use of ETC-216 on or before the Effective
Date infringed or misappropriated any Intellectual Property Rights of such Third
Party;     10.2.5.   there is no claim pending, or to the Knowledge of PFIZER,
threatened, by PFIZER alleging that a Third Party is or was infringing,
misappropriating or otherwise violating the Licensed Technology (except as noted
with respect to the Patent Rights on Schedule B2) in the Field in any country
within the Territory;

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  10.2.6.   to its Knowledge, and except as noted with respect to the Patent
Rights on Schedule B2, all issued patents included in the Patent Rights are
valid and enforceable, and no Third Party has challenged the extent, validity or
enforceability of any of the Patent Rights;     10.2.7.   to its Knowledge,
PFIZER has complied with all Applicable Laws, including any disclosure
requirements, in connection with the filing, prosecution and maintenance of the
Patent Rights (except as noted with respect to the Patent Rights on
Schedule B2);     10.2.8.   PFIZER is able to grant the licenses to LICENSEE as
purported to be granted pursuant to this Agreement, free and clear of any rights
of any Third Party. All Patent Rights (except as noted with respect to the
Patent Rights on Schedule B2) have been properly assigned to PFIZER and all
assignment documents with respect to the Patent Rights (except as noted with
respect to the Patent Rights on Schedule B2) have been properly executed and
recorded in the relevant U.S. and foreign patent offices;     10.2.9.   to
PFIZER’s Knowledge, each Regulatory Filing for ETC-216 submitted or filed by
PFIZER or any of its Affiliates was true, complete and accurate in all material
respects at the time of submission or filing and timely filed;     10.2.10.   to
its Knowledge, PFIZER and its Affiliates have not received any written notice
that indicates that any of the Regulatory Filings submitted or filed for ETC-216
are not currently in good standing with the relevant Regulatory Authorities or
that any “clinical hold” or similar regulatory action is in effect, provided,
however, that PFIZER has received a communication from the FDA dated August 15,
2007, stating that the FDA would anticipate asking PFIZER to comprehensively
summarize all pertinent in-vitro, pre-clinical, and clinical data both in a
submission and at a face to face meeting prior to or at the time of submission
of any new clinical protocols for the ETC-216 program;     10.2.11.   to its
Knowledge, (a) PFIZER and its Affiliates have complied in all material respects
with all Applicable Laws with respect to the Use of ETC-216 prior to the
Effective Date, (b) neither PFIZER nor any employee of PFIZER or its Affiliates
involved in the Development of ETC-216 has been debarred under Subsection (a) or
(b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a),
and (c) no employee of PFIZER or its Affiliates involved in the Development of
ETC-216 has been placed on any of the FDA clinical investigator enforcement
lists (including the (1) Disqualified/Totally Restricted List, (2) Restricted
List and (3) Adequate Assurances List);     10.2.12.   PFIZER has disclosed to
LICENSEE the data (including pre-clinical and clinical data and results),
correspondence and information in the possession or control of PFIZER or its
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      Development and Commercialization of ETC-216 that LICENSEE has requested;

  10.2.13.   there are no agreements to which PFIZER or any of its Affiliates is
a party pursuant to which PFIZER or any of its Affiliates has a license or holds
an immunity from suit, with respect to patents which (i) are granted or
registered, or to the Knowledge of PFIZER, applied for or pending, and (ii) but
for PFIZER’s or its Affiliates’ rights under such agreement, could be asserted
by a Third Party to be infringed by the Use of ETC-216 as a monotherapy. PFIZER
has previously delivered or made available to LICENSEE the written agreements
between PFIZER or its Affiliates, on the one hand, and any Third Parties, on the
other hand, necessary for the manufacture of ETC-216 for sale in the Field in
the Territory; provided, that LICENSEE acknowledges and agrees that the Danisco
Agreement has only been made available in redacted form, and provided, further,
that the foregoing is subject to the valid execution and delivery of the Danisco
Agreement by LICENSEE, PFIZER and Danisco on or before the Effective Date
hereof;     10.2.14.   certain provisions (Section 3.2, Section 4 and
Section 7.2 in part of the LICENSE AGREEMENT (as defined in the Danisco
Agreement) and Sections 4 and 5 of the FIRST AMENDMENT (as defined in the
Danisco Agreement) have been redacted because they are specific only to PFIZER
and are not relevant to LICENSEE’s rights and assumed obligations under the
Danisco Agreement, or they contain confidential financial or other business
information of PFIZER and Danisco; and     10.2.15.   all Transferred Inventory
(a) was manufactured in accordance with (i) cGMP and (ii) the specifications set
therefor by PFIZER and provided to LICENSEE, (b) conforms to such
specifications, (c) shall, at the time of delivery to LICENSEE, not contain any
material that would cause the Transferred Inventory to be adulterated or
misbranded under Applicable Laws.

  10.3.   Representations and Warranties by LICENSEE. LICENSEE represents and
warrants to PFIZER that it shall comply in all material respects with all
Applicable Law with respect to the performance of its obligations hereunder.
Without limiting the generality of the foregoing, (i) neither LICENSEE nor, to
the actual knowledge of LICENSEE, any employee, agent or subcontractor of
LICENSEE involved or to be involved in the Development of the Products has been
debarred under Subsection (a) or (b) of Section 306 of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 335a); (ii) no Person who is known by LICENSEE to
have been debarred under Subsection (a) or (b) of Section 306 of said Act will
be employed by LICENSEE in the performance of any activities hereunder; and
(iii) to the actual knowledge of LICENSEE, no Person on any of the FDA clinical
investigator enforcement lists (including the (1) Disqualified/Totally
Restricted List, (2) Restricted List and (3) Adequate Assurances List) will
participate in the performance of any activities hereunder. LICENSEE further
represents and warrants to PFIZER

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      that LICENSEE has the financial resources to perform its obligations under
this Agreement.

  10.4.   No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 10,
(a) NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT
LIMITED TO WARRANTIES OF TITLE, NON-INFRINGEMENT, VALIDITY, ENFORCEABILITY,
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE; AND (b) ANY INFORMATION,
DOCUMENTATION AND MATERIALS PROVIDED BY PFIZER OR ITS AFFILIATES IS MADE
AVAILABLE ON AN “AS IS” BASIS WITHOUT WARRANTY WITH RESPECT TO ACCURACY,
COMPLETENESS, COMPLIANCE WITH REGULATORY STANDARDS OR REGULATIONS OR FITNESS FOR
A PARTICULAR PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED.
FOR CLARITY, PFIZER MAKES NO WARRANTIES, EITHER EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE, REGARDING THE DANISCO IP OR ANY OTHER RIGHTS ACQUIRED BY LICENSEE
UNDER THE DANISCO AGREEMENT.     10.5.   Tangible Materials. LICENSEE
acknowledges and agrees that the Tangible Materials are experimental in nature
and may have unknown characteristics. LICENSEE shall use prudence and reasonable
care in the use, handling, storage, transportation, disposition, and containment
of the Tangible Materials. PFIZER makes no representations or warranties, and
assumes no liability, for LICENSEE’s use of the Tangible Materials.

11.   INDEMNIFICATION

  11.1.   Indemnification by LICENSEE. LICENSEE agrees to indemnify, hold
harmless and defend PFIZER and its Affiliates, and their respective officers,
directors, employees, contractors, agents and assigns (collectively, “Pfizer
Indemnitees”), from and against any Claims to the extent arising or resulting
from: (a) the Development of a Product by LICENSEE, its Affiliates,
subcontractors or sublicensees, (b) the Commercialization of a Product by
LICENSEE, its Affiliates, subcontractors or sublicensees, (c) the negligence,
recklessness or wrongful intentional acts or omissions of LICENSEE, its
Affiliates, subcontractors or sublicensees under this Agreement, (d) breach by
LICENSEE of any representation, warranty or covenant as set forth in this
Agreement, (e) breach by LICENSEE of the scope of the license set forth in
Section 2.1, or (f) any claim by a Brewer/Matin Party resulting from this
Agreement or any agreement or arrangement between LICENSEE and one or more
Brewer/Matin Party(ies). As used in this Section 11, “Claims” means
collectively, any and all Third Party demands, claims, actions and proceedings
(whether criminal or civil, in contract, tort or otherwise) for losses, damages,
liabilities, costs and expenses (including reasonable attorneys’ fees).
Notwithstanding the foregoing, this Section 11.1 does not limit or negate the
representations and warranties made by PFIZER under this Agreement.

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  11.2.   Indemnification by PFIZER. PFIZER agrees to indemnify, hold harmless
and defend LICENSEE and its Affiliates, and their respective officers,
directors, employees, contractors, agents and assigns (collectively, “Licensee
Indemnitees”), from and against any Claims to the extent arising or resulting
from: (a) the Development of a Product, on or before the Effective Date, by or
on behalf of PFIZER, its Affiliates, subcontractors, assignors or licensees,
(b) the negligence, recklessness or wrongful intentional acts or omissions of
PFIZER, its Affiliates, subcontractors, assignors or licensees, (c) breach by
PFIZER of any representation, warranty or covenant as set forth in this
Agreement, or (d) breach by PFIZER of the exclusive license granted to LICENSEE
pursuant to Section 2.1.     11.3.   Indemnification Procedure. In connection
with any Claim for which a Pfizer Indemnitee or a Licensee Indemnitee seeks
indemnification from LICENSEE or PFIZER, respectively, (the “Indemnitor”)
pursuant to this Agreement, PFIZER or LICENSEE, respectively, shall: (a) give
the Indemnitor prompt written notice of the Claim; provided, however, that
failure to provide such notice shall not relieve the Indemnitor from its
liability or obligation hereunder, except to the extent of any material
prejudice as a direct result of such failure; (b) cooperate with the Indemnitor,
at the Indemnitor’s expense, in connection with the defense and settlement of
the Claim; and (c) permit the Indemnitor to control the defense and settlement
of the Claim; provided, however, that the Indemnitor may not settle the Claim
without the prior written consent (which shall not be unreasonably withheld or
delayed) of PFIZER or LICENSEE, respectively, in the event such settlement
imposes any liability or obligation on the relevant Indemnitee or requires
payments by the relevant Indemnitee. Further, PFIZER or LICENSEE, respectively,
shall have the right to participate (but not control) and be represented in any
suit or action by advisory counsel of its selection and at its own expense.

12.   LIMITATION OF LIABILITY

  12.1.   Consequential Damages Waiver. EXCEPT FOR A BREACH OF SECTION 9 AND
EXCEPT FOR ANY INDEMNIFICATION OBLIGATIONS ARISING UNDER SECTION 11, NEITHER
PARTY SHALL BE LIABLE FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR
PUNITIVE DAMAGES, INCLUDING DAMAGES FOR LOST PROFITS OR LOST REVENUES,
REGARDLESS OF WHETHER IT HAS BEEN INFORMED OF THE POSSIBILITY OR LIKELIHOOD OF
SUCH DAMAGES OR THE TYPE OF CLAIM, CONTRACT OR TORT (INCLUDING NEGLIGENCE).

13.   TERM; TERMINATION

  13.1.   Term. The term of this Agreement shall commence as of the Effective
Date and shall expire upon the last-to-expire Royalty Term. Upon expiration of
the Royalty Term with respect to a Product and a country, the licenses granted
to LICENSEE under this Agreement shall convert to perpetual, exclusive, fully
paid-up, non-royalty-bearing licenses with respect to such Product in such
country.

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  13.2.   Termination for Cause. Each Party shall have the right, without
prejudice to any other remedies available to it at law or in equity, to
terminate this Agreement in the event the other Party breaches any of its
material obligations hereunder and fails to cure such breach within [**] days of
receiving notice thereof; provided, however, if such breach is capable of being
cured, but cannot be cured within such [**] day period, and the breaching Party
initiates actions to cure such breach within such period and thereafter
diligently pursues such actions, the breaching Party shall have such additional
period as is reasonable to cure such breach, but in no event will such
additional period exceed [**] days, and provided, further, that if such breach
is solely related to LICENSEE’s failure to pay Milestone Payments or Royalties
on Net Sales pursuant to Section 5 hereof, and such breach is not cured within
[**] days after such notice, PFIZER shall have the right thereafter to terminate
this Agreement immediately by giving written notice to LICENSEE. All timeframes
in this Section 13.2 shall be tolled until the resolution pursuant to Article 16
of any good faith dispute over the existence or nature of the breach, or over
the adequacy of the cure thereof. Any termination by a Party under this
Section 13.2 shall be without prejudice to any damages or other legal or
equitable remedies to which it may be entitled from the other Party.     13.3.  
Termination for a Bankruptcy Event. To the extent permitted by Applicable Law,
each Party shall have the right to terminate this Agreement upon written notice
to the other Party in the event of a Bankruptcy Event with respect to the other
Party. “Bankruptcy Event” means the occurrence of any of the following: (a) the
institution of any bankruptcy, receivership, insolvency, reorganization or other
similar proceedings by or against a Party under any bankruptcy, insolvency, or
other similar law now or hereinafter in effect, including any section or chapter
of the United States Bankruptcy Code, as amended or under any similar laws or
statutes of the United States or any state thereof (the “Bankruptcy Code”),
where in the case of involuntary proceedings such proceedings have not been
dismissed or discharged within one hundred (120) days after they are instituted,
(b) the making of an assignment for the benefit of creditors as to all or
substantially all of a Party’s assets, or (c) appointment of a receiver,
custodian, trustee, liquidator, assignee or other similar official for all or
substantially all of a Party’s assets.     13.4.   Termination by PFIZER. If
LICENSEE provides written notice to PFIZER of its intent to permanently abandon
the Development, manufacture and Commercialization, as applicable, of the
Products in the Territory, or if LICENSEE otherwise ceases to use Commercially
Reasonable Efforts for a period exceeding twelve (12) months with respect to the
Development, manufacture and Commercialization, as applicable, of at least one
Product in the Territory, PFIZER may, as its sole remedy, terminate this
Agreement at any time after the Effective Date by giving written notice to
LICENSEE thereof, subject to the cure periods and tolling provisions set forth
in Section 13.2.     13.5.   Termination by LICENSEE For Convenience. LICENSEE
shall have the right to terminate this Agreement, in its entirety or on a
Product-by-Product basis, for convenience upon ninety (90) days’ prior written
notice to PFIZER.

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  13.6.   Effect of Termination or Expiration.

13.6.1. Upon termination or expiration of this Agreement, LICENSEE shall pay to
PFIZER all amounts due to PFIZER with respect to the terminated Product(s) as of
the effective date of termination or expiration within thirty (30) days
following the effective date of termination or expiration.
13.6.2. Upon termination of this Agreement after a First Commercial Sale,
LICENSEE shall have the right to sell its remaining inventory of any terminated
Product(s) following the termination of this Agreement so long as LICENSEE has
fully paid, and continues to fully pay when due, any and all Royalties owed to
PFIZER, and LICENSEE otherwise is not in material breach of this Agreement.
13.6.3. Upon termination of this Agreement, all licenses granted by PFIZER to
LICENSEE with respect to the terminated Product(s) shall terminate, except for
those licenses described in Section 13.1 that have already vested; provided,
however, that PFIZER shall assume any related sublicenses granted by LICENSEE
hereunder, and such sublicenses shall survive such termination, but PFIZER shall
not be obligated to fulfill any obligations to such sublicensees beyond those
obligations required of PFIZER if this Agreement had not terminated.
13.6.4. With the exception of termination of this Agreement by LICENSEE pursuant
to Section 2.1.3, 13.2, 13.3 or 17.4, upon termination of this Agreement:

  (a)   LICENSEE hereby grants to PFIZER an exclusive, fully paid-up,
royalty-free, worldwide, transferable, perpetual and irrevocable license, with
the right to sublicense, under any Intellectual Property Rights (other than
Trademarks, for which Section 13.6.4(c) applies) Controlled by LICENSEE that
arose from the Development or Commercialization of the terminated Product by
LICENSEE under this Agreement, solely to Use the terminated Product in the Field
in the Territory.     (b)   To the extent permitted by applicable Regulatory
Authorities, LICENSEE shall: (i) transfer to PFIZER all Regulatory Filings
(including drug master files) and Regulatory Approvals held by LICENSEE with
respect to the terminated Product, and (ii) to the extent subsection (i) is not
permitted by the applicable Regulatory Authority, permit PFIZER to
cross-reference and rely upon any Regulatory Approvals and Regulatory Filings
filed by LICENSEE with respect to the terminated Product.     (c)   LICENSEE
hereby grants to PFIZER a non-exclusive, fully paid-up, royalty-free, worldwide,
transferable, sublicensable, perpetual and irrevocable license to use the
Trademarks Controlled by LICENSEE solely identifying the terminated Product
(but, for the sake of clarity, excluding any Trademark or part thereof that uses
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      LICENSEE, except to the extent incorporated into the terminated Product’s
name, or required by a Regulatory Authority to be displayed to indicate
manufacturing source or other identifying information with respect to the
inventory or Inventory described in clause (d) during the Migration Period) for
the purpose of manufacturing, marketing, distributing and selling the terminated
Product. As used herein. “Trademarks” means all registered and unregistered
trademarks, service marks, trade dress, trade names, logos, insignias, domain
names, symbols, designs, and combinations thereof.

  (d)   Upon PFIZER’s request with respect to any clinical trial then underway
with respect to the terminated Product, LICENSEE shall continue such trial for a
mutually agreed upon period after termination of this Agreement, which period,
unless otherwise agreed to by the Parties, shall not exceed [**] days after the
date on which notice of termination of this Agreement was issued (“Migration
Period”), and PFIZER shall bear all costs arising with respect thereto after the
effective date of termination of this Agreement. During the Migration Period,
LICENSEE shall provide such knowledge transfer and other training to PFIZER or
its Affiliates or a Third Party that is designated in writing by PFIZER
(“Designated Affiliate/Third Party”) as reasonably necessary for PFIZER or the
Designated Affiliate/Third Party to continue such activities. In connection with
such transfer, LICENSEE shall, at PFIZER’s option: (i) transfer to PFIZER or the
Designated Affiliate/Third Party the terminated Product then in LICENSEE’s
inventory at the cost paid or incurred by LICENSEE to manufacture or acquire
such Product, (ii) transfer to PFIZER or the Designated Affiliate/Third Party
all Inventory owned by LICENSEE at the cost paid or incurred by LICENSEE to
manufacture or acquire for such Inventory; and (iii) to the extent solely
related to such Product and assignable in accordance with the terms of the
relevant agreement, and subject to Section 13.6.3, assign to PFIZER or the
Designated Affiliate/Third Party any agreements with Third Parties with respect
to the Development or Commercialization of the terminated Product. PFIZER shall
reimburse LICENSEE for all reasonable, documented out-of-pockets costs and
expenses (but not LICENSEE’s internal costs or the costs of packing and shipping
such inventory or the Inventory) incurred in connection therewith. As used
herein, “Inventory” means all components and works in process then held by
LICENSEE with respect to the manufacture of the terminated Product.

  13.7.   Survival. Expiration or termination of this Agreement shall not
relieve the Parties of any obligation accruing hereunder prior to such
expiration or termination. In addition, the provisions of Sections 2.3, 2.4,
2.5, 6.1, 7.1, 9, 10.4, 11, 12, 13.6, 13.7, 14, 15, 16, 17.1, 17.2, 17.3, 17.5,
17.6, 17.7, 17.8, 17.10, 17.11, 17.12, 17.13 and 17.14 shall survive expiration
or termination of this Agreement.

14.   TRADEMARKS.

  14.1.   Trademarks. Subject to PFIZER’s rights pursuant to Section 13.6.5(c)
and each Party’s rights pursuant to Section 9, neither Party (nor any of its
Affiliates or agents)

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      shall use the Trademarks of the other Party or its Affiliates in any press
release, publication or other form of promotional disclosure without the prior
written consent of the other Party in each instance.

15.   LICENSEE INSURANCE

  15.1.   Insurance Requirements. LICENSEE will maintain during the term of this
Agreement and until the later of: (a) three (3) years after termination or
expiration of this Agreement, or (b) the date that all statutes of limitation
covering claims or suits that may be instituted for personal injury based on the
sale or use of the Products have expired, commercial general liability insurance
from a minimum “A-” AM Bests rated insurance company or through self-insurance,
including contractual liability and product liability or clinical trials, if
applicable, with coverage limits of not less than five million US dollars
($5,000,000) per occurrence and five million US dollars ($5,000,000) in the
aggregate. LICENSEE has the right to provide the total limits required by any
combination of primary and umbrella/excess coverage. The minimum level of
insurance set forth herein shall not be construed to create a limit on
LICENSEE’s liability hereunder. LICENSEE shall use reasonable efforts to ensure
that (y) such policies shall name PFIZER and its Affiliates as additional
insured and provide a waiver of subrogation in favor of PFIZER and its
Affiliates, and (z) such insurance policies shall be primary and
non-contributing with respect to any other similar insurance policies available
to PFIZER or its Affiliates. Any deductibles for such insurance shall be assumed
by LICENSEE.     15.2.   Policy Notification. LICENSEE shall provide PFIZER with
certified copies of such policies or original certificates of insurance
evidencing such insurance: (a) prior to execution by both Parties of this
Agreement, and (b) prior to expiration of any one coverage. Such certificates
shall provide that PFIZER shall be given at least thirty (30) days (ten
(10) days in the case of cancellation for non-payment of premium) written notice
prior to cancellation, termination or any change to restrict the coverage or
reduce the limits afforded.

16.   DISPUTE RESOLUTION

  16.1.   General. The following procedures shall be used to resolve any dispute
arising out of or in connection with this Agreement:

16.1.1. Meeting. Promptly after the written request of either Party, each of the
Parties shall appoint a designated representative to meet in person or by
telephone to attempt in good faith to resolve any dispute. If the designated
representatives do not resolve the dispute within [**] days of such request,
then an executive officer of each Party shall meet in person or by telephone to
review and attempt to resolve the dispute in good faith. The executive officers
shall have [**] days to attempt to resolve the dispute.

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16.1.2. Arbitration.

  (a)   Any disputes that are not otherwise resolved by the Parties or by
mediation shall be submitted to binding arbitration with the office of the
American Arbitration Association in New York County, New York in accordance with
the then-prevailing commercial arbitration rules of the American Arbitration
Association. The American Arbitration Association shall appoint a single
arbitrator who is neutral to the Parties.     (b)   The arbitrator shall not be
an officer or employee of either Party. The cost of the arbitration, including
the fees and expenses of the arbitrator, will be shared equally by the Parties.
The substantially prevailing Party shall be entitled to recover from the losing
Party the substantially prevailing Party’s attorneys’ fees and costs. The
arbitrator shall have the right to apportion liability between the Parties, but
will not have the authority to award any damages or remedies not available under
the express terms of this Agreement. The arbitration award will be presented to
the Parties in writing, and upon the request of either Party, will include
findings of fact and, where appropriate, conclusions of law. The award may be
confirmed and enforced in any court of competent jurisdiction.     (c)   Either
Party may seek injunctive relief from any court of competent jurisdiction in
order to enforce compliance with the provisions of this Section 16.1.2.

  16.2.   THE PARTIES EXPRESSLY WAIVE AND FOREGO ANY RIGHT TO TRIAL BY JURY.

17.   GENERAL PROVISIONS

  17.1.   Assignment. Neither Party may assign its rights and obligations under
this Agreement without the other Party’s prior written consent, except that:
(a) PFIZER may assign to a Third Party its rights to receive some or all of the
fees payable hereunder, (b) each Party may assign its rights and obligations
under this Agreement or any part hereof to one or more of its Affiliates without
the consent of the other Party; and (c) either Party may assign this Agreement
in its entirety to a successor to all or substantially all of its business and
assets to which this Agreement relates. The assigning Party shall provide the
other Party with prompt written notice of any such assignment. Any permitted
assignee pursuant to clauses (b) and (c) above shall assume all obligations of
its assignor under this Agreement, and no permitted assignment shall relieve the
assignor of liability for its obligations hereunder. Any attempted assignment in
contravention of the foregoing shall be void.     17.2.   Severability. Should
one or more of the provisions of this Agreement become void or unenforceable as
a matter of law, then such provision will be ineffective only to the extent of
such prohibition or invalidity, without invalidating the remainder of this
Agreement, and the Parties agree to substitute a valid and enforceable provision

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      therefor which, as nearly as possible, achieves the desired economic
effect and mutual understanding of the Parties under this Agreement.

  17.3.   Governing Law; Exclusive Jurisdiction.

17.3.1. This Agreement shall be governed by and construed under the laws in
effect in the State of New York, US, without giving effect to any conflicts of
laws provision thereof or of any other jurisdiction that would produce a
contrary result, except that issues subject to the arbitration clause and any
arbitration hereunder shall be governed by the applicable commercial arbitration
rules and regulations.
17.3.2. The federal and state courts of New York shall have exclusive
jurisdiction over any action not resolved pursuant to Section 16.1 brought to
enforce this Agreement, and each of the Parties hereto irrevocably: (a) submits
to such exclusive jurisdiction for such purpose; (b) waives any objection which
it may have at any time to the laying of venue of any proceedings brought in
such courts; (c) waives any claim that such proceedings have been brought in an
inconvenient forum, and (d) further waives the right to object with respect to
such proceedings that any such court does no have jurisdiction over such Party.
Notwithstanding the foregoing, application may be made to any court of competent
jurisdiction with respect to (i) the enforcement of any judgment or award or
(ii) a Party seeking injunctive or other equitable relief in connection with
this Agreement.

  17.4.   Force Majeure. Except with respect to delays or nonperformance caused
by the negligent or intentional act or omission of a Party, any delay or
nonperformance by such Party (other than payment obligations under this
Agreement) will not be considered a breach of this Agreement to the extent such
delay or nonperformance is caused by acts of God, natural disasters, acts of the
government or civil or military authority, fire, floods, epidemics, quarantine,
energy crises, war or riots or other cause outside of the reasonable control of
such Party (each, a “Force Majeure Event”), provided that the Party affected by
such Force Majeure Event will promptly begin or resume performance as soon as
reasonably practicable after the event has abated. If the Force Majeure Event
prevents a Party from performing any of its material obligations under this
Agreement for one hundred eighty (180) days or more, then the other Party may
terminate this Agreement immediately upon written notice to the non-performing
Party.     17.5.   Waivers and Amendments. The failure of any Party to assert a
right hereunder or to insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right or excuse a similar
subsequent failure to perform any such term or condition by the other Party. No
waiver shall be effective unless it has been given in writing and signed by the
Party giving such waiver. No provision of this Agreement may be amended or
modified other than by a written document signed by authorized representatives
of each Party.

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  17.6.   Relationship of the Parties. Nothing contained in this Agreement shall
be deemed to constitute a partnership, joint venture, or legal entity of any
type between PFIZER and LICENSEE, or to constitute one Party as the agent of the
other. Moreover, each Party agrees not to construe this Agreement, or any of the
transactions contemplated hereby, as a partnership for any tax purposes. Each
Party shall act solely as an independent contractor, and nothing in this
Agreement shall be construed to give any Party the power or authority to act
for, bind, or commit the other Party.     17.7.   Successors and Assigns. This
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their respective successors and permitted assigns.     17.8.   Notices. All
notices, consents, waivers, and other communications under this Agreement must
be in writing and will be deemed to have been duly given when: (a) delivered by
hand (with written confirmation of receipt), (b) sent by fax (with written
confirmation of receipt), provided that a copy is sent by an internationally
recognized overnight delivery service (receipt requested), or (c) when received
by the addressee, if sent by an internationally recognized overnight delivery
service (receipt requested), in each case to the appropriate addresses and fax
numbers set forth below (or to such other addresses and fax numbers as a Party
may designate by written notice pursuant to this Section 17.8):

         
 
  If to PFIZER:    
 
      Pfizer Inc.
 
      235 East 42nd Street
 
      New York, NY 10017
 
      Fax: 646-348-8157
 
      Attention: General Counsel
 
       
 
  If to LICENSEE:    
 
       
 
      The Medicines Company
 
      8 Sylvan Way
 
      Parsippany, NJ 07054
 
      Fax: 862-207-6062
 
      Attention: General Counsel
 
       
 
      With a copy to:
 
       
 
      WilmerHale
 
      60 State Street
 
      Boston, MA 02109
 
      Fax: 1-617-526-5000
 
      Attention: David E. Redlick, Esq.

  17.9.   Further Assurances. LICENSEE and PFIZER hereby covenant and agree,
without the necessity of any further consideration, to execute, acknowledge and

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      deliver any and all such other documents and take any such other action as
may be reasonably necessary or appropriate to carry out the intent and purposes
of this Agreement.

  17.10.   No Third Party Beneficiary Rights. This Agreement is not intended to
and shall not be construed to give any Third Party (other than the Pfizer
Indemnitees and Licensee Indemnitees) any interest or rights (including any
third party beneficiary rights) with respect to or in connection with any
agreement or provision contained herein or contemplated hereby.     17.11.  
Entire Agreement; Confidentiality Agreement. This Agreement, which includes its
Schedules, sets forth the entire agreement and understanding of the Parties as
to the subject matter hereof and supersedes all proposals, oral or written, and
all other prior communications between the Parties with respect to such subject
matter, including the Confidential Disclosure Agreement between LICENSEE and
PFIZER dated as of July 7, 2009 (the “CDA”). The Parties acknowledge and agree
that, as of the Effective Date, all Confidential Information (as defined in the
CDA) disclosed by PFIZER or its Affiliates pursuant to the CDA shall be
considered LICENSEE’s and PFIZER’s Confidential Information and subject to the
terms set forth in this Agreement.     17.12.   Counterparts. This Agreement may
be executed in two or more counterparts, any of which may be executed and
transmitted by facsimile or other electronic method, and each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.     17.13.   Cumulative Remedies. No remedy referred to in this
Agreement is intended to be exclusive, but each shall be cumulative and in
addition to any other remedy referred to in this Agreement or otherwise
available under law.     17.14.   Waiver of Rule of Construction;
Interpretation. Each Party has had the opportunity to consult with counsel in
connection with the review, drafting and negotiation of this Agreement.
Accordingly, any rule of construction that any ambiguity in this Agreement shall
be construed against the drafting Party shall not apply. In construing this
Agreement, (a) use of the singular includes the plural and vice versa; (b)
“include” or “including” means “including without limitation”, and (c) except
where the context otherwise requires, the word “or” is used in the inclusive
sense. References to “PFIZER” herein shall include any Affiliate of Pfizer Inc.
to the extent that the relevant Intellectual Property Rights or other assets are
held by such Affiliate, any activities with respect to ETC-216 were conducted by
such Affiliate or any rights are exercised hereunder by such Affiliate, and
Pfizer Inc. shall cause such Affiliates to fulfill the relevant obligations
under this Agreement. For the sake of clarity, the materials described in
Schedule C shall include such materials generated by or on behalf of Esperion
Therapeutics, Inc. prior to its acquisition by Pfizer Inc.

[Signatures on next page]

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     IN WITNESS WHEREOF, the Parties intending to be bound have caused this
Agreement to be executed by their duly authorized representatives as of the
Effective Date.

              THE MEDICINES COMPANY   PFIZER INC.
 
           
By:
  /s/ Glenn Sblendorio   By:   /s/ Willaim R. Ringo
 
           
 
  Name: Glenn Sblendorio       Name: William R. Ringo
 
  Title: EVP and CFO       Title: SVP, Worldwide Business Development, Strategy
and Innovation

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SCHEDULE A: ETC-216
Description
ETC-216 is a macromolecular complex consisting of a dimer of the recombinant
apolipoprotein A-I Milano (rapoA-IM, a genetic variant of naturally occurring
apolipoprotein A-I (apoA-I)) and POPC
(1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine) a naturally occurring
phospholipid.
[**]

 

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SCHEDULE B: PATENT RIGHTS
Schedule B1:
[**]
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 16 pages were omitted pursuant to a request for
confidential treatment.

 

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SCHEDULE C
DOCUMENTATION AND TANGIBLE MATERIALS
For purposes of this Schedule C only, references to “ETC-216” means the compound
designated by PFIZER as ETC-216 as described in Schedule A hereto, regardless of
the manufacturing process used in the generation thereof.
1. Non-Clinical Documentation
1.1 GLP Studies Documentation. PFIZER will provide to LICENSEE copies of
protocols, data, results and reports that were generated as part of GLP Studies
conducted by or on behalf of PFIZER. As used herein, “GLP Studies” means
non-clinical toxicology and safety studies of ETC-216 that are: (a) conducted in
accordance with the standards for good laboratory practices under the ICH
guidelines and the applicable standards under the laws of the United States, and
(b) filed or intended by PFIZER to be filed as part of the Regulatory Filings.
1.2 Non-GLP Studies Documentation. PFIZER will provide to LICENSEE a summary of
the results that were generated as part of relevant Non-GLP Studies conducted by
or on behalf of PFIZER. As used herein, “Non-GLP Studies” means non-clinical
studies (including pharmacology studies) of the Products other than the GLP
Studies.
2. Clinical Documentation.
2.1 Trial Master File Documentation. PFIZER will provide to LICENSEE the trial
master files (or equivalent) for clinical studies of ETC-216 conducted by or on
behalf of PFIZER.
2.2 Study Report Documentation. PFIZER will provide to LICENSEE study reports
and supporting data, including SAS data sets, regarding the clinical trials of
ETC-216 generated by or on behalf of PFIZER.
2.3 Adverse Events Documentation. PFIZER will provide to LICENSEE a summary of
any and all adverse events reported to PFIZER for clinical trials of ETC-216,
including specific narratives and attributions for serious adverse events.
3. Regulatory Documentation. PFIZER will provide to LICENSEE any filings,
correspondence, and official meeting minutes between Regulatory Authorities and
PFIZER with respect to ETC-216.
4. Manufacturing/Pharm. Sci. Documentation. PFIZER will provide to LICENSEE
(a) all current batch records (including process and packaging information),
(b) all certificates of analyses, analytical test methods, analytical test
reports, process development reports (drug substance and drug product),
stability study reports, inventory records, analytical method development
reports, analytical method validation reports, stability summary tables and
formulation development reports, and (c) a drug substance campaign summary
report.

 

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5. Data Room Documentation. PFIZER will provide to LICENSEE electronic copies
(if available) or hard copies of any other materials included in the electronic
data room set up by PFIZER on the Intralinks platform space relating to ETC-216,
including the documents listed in Schedule F hereto.
6. Tangible Materials. Within [**] Business Days following the Effective Date,
LICENSEE will designate the appropriate facility for PFIZER to ship all Tangible
Materials. PFIZER will arrange for shipment of such Tangible Materials to such
facility within [**] months the following Effective Date. LICENSEE will pay for
storage costs plus all packaging, handling and shipping costs of the Tangible
Materials. If LICENSEE fails to so designate a facility, PFIZER will have the
right, but not the obligation, to destroy all Tangible Materials. “Tangible
Materials” means the Specimens and the Transferred Inventory.
6.1 Specimen Transfer. PFIZER will provide to LICENSEE Specimens. As used
herein, “Specimens” means specimens or samples that: (a) were generated as part
of toxicology GLP Studies, (b) are retained by PFIZER as of the Effective Date,
and (c) are reasonably retrievable by PFIZER.
6.2 Inventory Transfer. PFIZER will transfer to LICENSEE the manufacturing
inventories set forth in Schedule E hereto (collectively, “Transferred
Inventory”).

 

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SCHEDULE D: PRESS RELEASE
THE MEDICINES COMPANY ACQUIRES APOA-I MILANO FROM PFIZER
Product Has Potential to Reverse Plaque Buildup in Arteries
FOR U.S. AUDIENCES ONLY
PARSIPPANY, NJ, and NEW YORK, NY, DECEMBER 21, 2009 — The Medicines Company
(NASDAQ: MDCO) today announced the exclusive worldwide licensing of ApoA-I
Milano from Pfizer Inc. (NYSE:PFE). ApoA-I Milano is a naturally occurring
variant of a protein found in human high-density lipoprotein (HDL) that has the
potential to reverse atherosclerotic plaque development and reduce the risk of
coronary events in patients with acute coronary syndrome (ACS).
Under the terms of the agreement, Pfizer will receive an up-front payment of
$10 million for ApoA-I Milano and will also receive additional payments upon the
achievement of certain clinical, regulatory and sales milestones up to a total
of $410 million. Pfizer will also be eligible to receive single-digit royalty
payments on worldwide net sales of ApoA-I Milano. The Medicines Company will
also pay $7.5 million to a third party.
“The acquisition of ApoA-I Milano provides The Medicines Company with a
significant asset that fits well within our current areas of business” said
Clive Meanwell MD, PhD, Chairman and Chief Executive Officer of The Medicines
Company. “By mimicking the actions of HDL, ApoA-I Milano has been shown in an
early clinical study, published in JAMA, to rapidly reduce the size of
atherosclerotic plaques. This is an area of cardiovascular medicine that is not
yet served by currently available therapies — and the potential to provide
disease modification for patients with high risk atheroma and associated acute
coronary syndromes represents a major innovation opportunity.”
“We are very pleased to partner with The Medicines Company to advance the Apo-I
Milano program as part of our strategy of out licensing programs that Pfizer no
longer pursues internally. The Apo-I Milano program has the potential to become
a valuable and innovative medicine for the treatment of cardiovascular diseases.
We look forward to seeing it progress, thanks to The Medicines Company’s
experience in conducting large clinical trials in cardiovascular patients as
well as their expertise in treating critical and intensive care patients.” said
David K. Rosen DVM, Head of Out Licensing for Pfizer Inc.
About ApoA-I Milano
ApoA-I Milano is a naturally occurring variant of apolipoproteinA-I (ApoA-I),
the main protein component of the HDL lipoprotein particle. The variant has been
found in approximately 45 individuals from Limone sul Garda, a small village in
northern Italy. Carriers of this variant appear to have reduced risk of
cardiovascular disease. Patented by the University of Milan and Pharmacia,
ApoA-I Milano was licensed to Esperion Therapeutics. Esperion was subsequently

 

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acquired by Pfizer in 2004. Since that time, Pfizer has moved development
forward with improvements to the original manufacturing process.
In multiple non-clinical models, ApoA-I Milano rapidly removed excess
cholesterol from artery walls, thereby stabilizing and regressing
atherosclerotic plaque. A phase I-II study in 36 patients demonstrated
statistically significant reductions on coronary plaque volume by 4.2% in
6 weeks. These findings were published in the Journal of the American Medical
Association and continue to be widely referenced and discussed.
The Medicines Company will host a conference call today, Monday, December 21,
2009 at 8:30 a.m. Eastern Time. The conference call will be available via phone
and webcast. The dial in information is listed below:
Domestic Dial In: 866-285-1709
International Dial In: 617-213-8060
Passcode for both dial in numbers: 31802183
Replay is available from 11:30 a.m. Eastern Time following the conference call
through January 4, 2010. To hear a replay of the call, dial 888-286-8010
(domestic) and 617-801-6888 (international). Passcode for both dial in numbers
is 58773912.
This call is being webcast and can be accessed at The Medicines Company’s
website at www.themedicinescompany.com.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of
critical care patients through the delivery of innovative, cost-effective
medicines to the worldwide hospital marketplace. The Company markets Angiomax®
(bivalirudin) in the United States and other countries for use in patients
undergoing coronary angioplasty, and Cleviprex® (clevidipine butyrate)
injectable emulsion in the United States for the reduction of blood pressure
when oral therapy is not feasible or not desirable. The Medicines Company’s
website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are
not purely historical, and all other statements that are not purely historical,
may be deemed to be forward-looking statements for purposes of the safe harbor
provisions under The Private Securities Litigation Reform Act of 1995. Without
limiting the foregoing, the words “believes,” “anticipates” and “expects” and
similar expressions are intended to identify forward-looking statements. These
forward-looking statements involve known and unknown risks and uncertainties
that may cause the Company’s actual results, levels of activity, performance or
achievements to be materially different from those expressed or implied by these
forward-looking statements. Important factors that may cause or contribute to
such differences include whether physicians, patients and other key
decision-makers will accept clinical trial results,

 

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whether clinical trial results will warrant submission of applications for
regulatory approval, whether the Company’s products will advance in the clinical
trials process on a timely basis or at all, whether the Company will be able to
obtain regulatory approvals, whether we are able to obtain or maintain patent
protection for the intellectual property relating to the Company’s products and
such other factors as are set forth in the risk factors detailed from time to
time in the Company’s periodic reports and registration statements filed with
the Securities and Exchange Commission including, without limitation, the risk
factors detailed in the Company’s Quarterly Report on Form 10-Q filed on
November 9, 2009, which are incorporated herein by reference. The Company
specifically disclaims any obligation to update these forward-looking
statements.

 

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SCHEDULE E: TRANSFERRED INVENTORY
[**]

 

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SCHEDULE F: ELECTRONIC DATA ROOM SUMMARY
[**]
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of two pages were omitted pursuant to a request for
confidential treatment.