Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.

Exhibit 10.4

EXECUTION COPY

LICENSE AND SUPPLY AGREEMENT
This License and Supply Agreement (this “Agreement”) is entered into as of the
22nd day of January, 2012 (the “Effective Date”), by and between The Medicines
Company, a corporation organized and existing under the laws of the State of
Delaware, having a place of business at 8 Sylvan Way, Parsippany, New Jersey
07054 (“MDCO”), and on the other hand, APP Pharmaceuticals, LLC, a limited
liability company organized and existing under the laws of the State of
Delaware, having a place of business at 1501 East Woodfield Road, Suite 300
East, Schaumburg, Illinois 60173 (“APP”). MDCO and APP are collectively referred
to herein as “Parties,” or each separately, as a “Party.”
RECITALS
WHEREAS, MDCO wishes to acquire a license to sell the Products (defined below)
in the Territory (defined below);
WHEREAS, MDCO wishes to engage APP to manufacture and supply the Products,
subject to and in accordance with the terms and conditions set forth in this
Agreement, and APP wishes to be so engaged; and
WHEREAS, APP and/or its Affiliates have the capability, capacity and desire to
manufacture and supply the Products.
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual
covenants contained herein, and other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the Parties agree as
follows:
ARTICLE I
DEFINITIONS
SECTION 1.1. As used herein, the following terms shall have the following
meanings:
“Abbreviated New Drug Application” shall mean an Abbreviated New Drug
Application filed with the FDA to manufacture and/or sell a pharmaceutical
product pursuant to the FDA's rules and regulations.
“Act” shall mean the United States Food, Drug and Cosmetic Act (21 U.S.C. § 301,
et seq.) and the regulations promulgated thereunder, as each may be amended from
time to time.
“Affiliates” means with respect to any Party, any partnership, association,
corporation, limited liability company, trust, or other legal entity, that is
controlled by, controls, or is under common control with, that Party. For the
purposes of this definition, “control” when used with respect to any Person
means the power to direct the management and policies of such Person, directly
or indirectly, whether through the ownership of voting securities, by contract
or otherwise, and the terms “controlling” and “controlled” have correlative

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meanings.
“Batch Quantity,” with respect to each Product, shall mean, subject to the last
sentence of Section 2.5, the quantity of Product listed in Exhibit A attached
hereto.
“cGMP” shall mean the current good manufacturing practices required by the FDA
and set forth in the Act or FDA regulations, policies or guidelines in effect at
the time in question for the manufacture and testing of pharmaceutical
materials, including as described in Parts 210 and 211 of Title 21 of the United
States' Code of Federal Regulations, all as updated, amended and revised from
time to time.
“Commercially Reasonable Efforts” shall mean, with respect to each Party,
commercially reasonable efforts in accordance with such Party's business, legal,
medical, and scientific judgment and in accordance with the efforts and
resources such Party would use for a product owned by it or to which it has
rights, which is of similar market potential, at a similar stage in its product
life, taking into account the competitiveness of the market place, the
proprietary position of the product, the regulatory structure involved, the
potential for litigation or other disputes associated with such product, the
intellectual property issues associated with such product, the profitability of
the product and other relevant factors.
“Confidential Information” shall mean, with respect to a Party, all information
of any kind whatsoever (including without limitation, data, compilations,
formulae, models, patent disclosures, procedures, processes, projections,
protocols, results of experimentation and testing, specifications, strategies,
and techniques), and all tangible and intangible embodiments thereof of any kind
whatsoever (including without limitation, apparatus, compositions, documents,
drawings, machinery, patent applications, records and reports), which is
disclosed by such Party to the other Party or any of its Affiliates.
Confidential Information shall also include the terms and existence of this
Agreement and other agreements. Notwithstanding the foregoing, Confidential
Information of a Party shall not include information which the other Party can
establish by competent evidence (a) to have been publicly known prior to
disclosure of such information by the disclosing Party to the other Party, (b)
to have become publicly known, without fault on the part of the other Party,
subsequent to disclosure of such information by the disclosing Party to the
other Party, (c) to have been received by the other Party or one of its
Affiliates free of an obligation of confidentiality at any time from a source,
other than the disclosing Party, rightfully having possession of and the right
to disclose such information free of an obligation of confidentiality, (d) to
have been otherwise known by the other Party or any of its Affiliates prior to
disclosure of such information by the disclosing Party to the other Party, or
(e) to have been developed by the receiving Party after receipt of such
information, and which the receiving Party can demonstrate through written
documentation, was not developed through use of such information.
“Cost of Goods” shall mean APP's direct costs (including out-of-pocket costs and
directly allocable internal overheads, but not including allocations of
corporate or general overheads or of any idle or excess capacity) of
manufacture, packaging, shipping, labeling, testing, and validation of Product,
accrued in accordance with GAAP.
“FDA” shall mean the United States Food and Drug Administration (and any
successor agency thereto).
“GAAP” shall mean Generally Accepted Accounting Principles as used and defined
in the United States, consistently applied.
“Intellectual Property” shall mean any and all of the following, whether or not
registered, in the United States and all other jurisdictions throughout the
world, only to the extent necessary to manufacture, sell, market and promote the
Products in the Territory: (i) inventions and improvements thereto, whether or

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not patentable, and patents and patent applications (including all reissues,
divisions, continuations, continuations-in-part, extensions and reexaminations
thereof); (ii) trademarks, service marks, trade dress, logos, domain names,
rights of publicity, trade names and corporate names, and all goodwill
associated therewith; (iii) copyrights, including all derivative works, moral
rights, renewals, extensions, reversions or restorations associated with such
copyrights, now or hereafter provided by law, regardless of the medium of
fixation or means of expression; (iv) computer software (including source code,
object code, firmware, operating systems and specifications); (v) trade secrets
and, whether or not confidential, business information (including pricing and
cost information, business and marketing plans and customer and supplier lists)
and know how; (vi) databases and data collections; (vii) any other type of
intellectual property right; (viii) registrations and applications for
registration of any of the foregoing; (ix) copies and tangible embodiments of
any of the foregoing; and (x) rights to sue or recover and retain damages, costs
and attorneys' fees for past, present or future infringement, misappropriation
or violation of any of the foregoing.
“Licensed Intellectual Property” means all Intellectual Property and Marketing
Authorizations owned or controlled by APP or an Affiliate solely to the extent
necessary for the sale of the Product.
“Marketing Authorizations” means any federal, state, or local approvals,
licenses, permits, applications, registrations or authorizations approved by,
filed with, or submitted to any governmental authority, such as the FDA,
including all Abbreviated New Applications and New Drug Applications, including
those listed in Exhibit B attached hereto.
“NDC” shall mean, with respect to each Product, the national drug code for such
Product.
“New Drug Application” shall mean a New Drug Application filed with the FDA
pursuant to and under 21 U.S.C. § 355(b) of the Act, together with the FDA's
implementing rules and regulations.
“Partial Batch Quantities” shall mean quantities of Product amounting to less
than full Batch Quantities, which may be supplied by APP, subject to APP's
manufacturing requirements and schedules.
“Person” shall mean an individual, corporation, partnership, joint venture,
limited liability company, trust or unincorporated organization, joint stock
company or other similar organization, a government or any political subdivision
thereof, or any other legal entity
“Product(s)” shall mean those pharmaceutical products listed in Exhibit C
attached hereto in the dosage strengths listed in Exhibit C.
“Product Specifications” shall mean the specifications for a Product as set
forth in the applicable Marketing Authorizations for the Product, including (as
applicable) statements of manufacturing, labeling, packaging, storage and
quality control procedures (as such may be revised from time to time) together
with any additional specifications that may be agreed to between the Parties and
the specifications for the Products as set forth in the Quality Agreement, with
such modifications as APP and MDCO may agree upon from time to time in
accordance with Section 4.3.
“Purchase Price” shall have the meaning as defined in Section 5.1.
“Quality Agreement” shall mean the pharmaceutical Quality Agreement to be
entered into by APP and MDCO as soon as reasonably practicable after the
Effective Date hereof. In the event of a conflict between the terms of this
Agreement and the Quality Agreement, the terms of this Agreement shall govern.
“Territory” shall mean the United States of America and its possessions and
territories.

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SECTION 1.2. Other Defined Terms. The following terms are defined in the
Articles or other sections of the Agreement indicated below.
Change in Control
12.7

MDCO Parties
11.1

Detailed Product Forecast
2.3.2

Disclosing Party
10.2.3

Forecast Commencement Quarter
2.3.2

Indemnified Party
11.3

Indemnifying Party
11.3

APP Parties
11.2

Initial Product Forecast
2.3.1

Losses
11.1

Receiving Party
10.1

Report
6.3.1

Requirements
2.2

Supply Interruption
2.8

Term
8.1

SECTION 1.3. Interpretation. Unless otherwise indicated to the contrary herein
by the context or use thereof (i) the words, “herein,” “hereto,” “hereof” and
words of similar import refer to this Agreement as a whole and not to any
particular Section or paragraph hereof, (ii) the word “including” means
“including, but not limited to,” (iii) words importing the singular will also
include the plural, and vice versa, and (iv) any reference to any federal,
state, local, or foreign statute or law will be deemed also to refer to all
rules and regulations promulgated thereunder. References to $ will be references
to United States Dollars.
ARTICLE II
PURCHASE AND SALE
SECTION 2.1. Agreement to Supply. APP shall use Commercially Reasonable Efforts
to manufacture, test, package and sell to MDCO all such quantities of the
Product as MDCO shall order from APP in accordance with the terms and
conditions, and subject to the obligations and limitations set forth in this
Agreement, including Sections 2.3 and 2.8 hereof.
SECTION 2.2. Agreement to Purchase; Exclusivity. Subject to the terms and
conditions of this Agreement, (i) MDCO agrees to purchase exclusively from APP
MDCO's entire commercial requirements of the Product for resale solely to
hospitals and integrated delivery networks in the Territory (hereinafter
referred to as MDCO's “Requirements”), and (ii) MDCO shall not manufacture
itself or purchase or procure from any other manufacturer or source, including
any of its Affiliates, partners or any other Persons with which any of them has
entered into any collaboration arrangement regarding the Product, any of its
Requirements of the Product. Should MDCO's profit margin on any Product fall to
or below [**]%, MDCO shall be excused from the exclusivity requirements of this
Section 2.2 with respect to such Product.
SECTION 2.3. Forecasts.
SECTION 2.3.1. Within [**] days of the Effectice Date, MDCO shall provide APP
with a forecast setting forth MDCO's Requirements of Product for the period
commencing [**] days from

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the date of the delivery of such forecast to APP and ending on [**] (the
“Initial Product Forecast”). MDCO's forecasted Requirements for the Initial
Product Forecast shall be firm and binding upon MDCO and shall be accompanied by
a purchase order for the quantities of Product specified in such Initial Product
Forecast.
SECTION 2.3.2. Beginning [**], at least [**] days prior to the commencement of
each calendar quarter (with respect to the forecast for the period then
commencing, the “Forecast Commencement Quarter”) during the Term, MDCO shall
provide APP with a written estimate of MDCO's Requirements for each dosage
strength and package size of each Product during the [**] commencing with the
Forecast Commencement Quarter, delineated by [**] (a “Detailed Product
Forecast”). MDCO's forecasted Requirements for the first [**] of each Detailed
Product Forecast provided hereunder shall be firm and binding upon MDCO and each
Detailed Product Forecast shall be accompanied by a purchase order for the
quantities of Product specified for such [**] period in such Forecast
Commencement Quarter. The remaining portion of each Detailed Product Forecast
shall be firm subject to permissible variances set forth in Section 2.3.3. If
MDCO fails to timely provide any updated Detailed Product Forecast, the Detailed
Product Forecast last provided by MDCO shall be deemed to be MDCO's Detailed
Product Forecast for the next succeeding [**] period.
SECTION 2.3.3. Each subsequent Detailed Product Forecast may be updated to
modify the amounts estimated in the previous Detailed Product Forecast for the
periods of time in question subject to the following limitation: the volume
specified for any calendar quarter covered by such subsequent Detailed Product
Forecast shall not be increased or decreased by more than [**] percent ([**]%)
from the volume specified for such quarter in the prior Detailed Product
Forecast without APP's written consent.
SECTION 2.4. Purchase Orders.
SECTION 2.4.1. In accordance with the terms of this Agreement, MDCO will
initiate orders for the Product by submitting written purchase orders to APP at
the following address:
APP Pharmaceuticals, LLC
Attn: Purchasing Department
1501 East Woodfield Road
Suite 300 East
Schaumburg, Illinois 60173
 

SECTION 2.4.2. Each purchase order submitted by MDCO shall specify a required
delivery date not less than [**] days after the date of such purchase order. APP
will provide written confirmation of each purchase order within [**] days after
receipt thereof; provided, however, that APP shall have no obligation to accept
or confirm any purchase order that is inconsistent with the terms of this
Agreement.
SECTION 2.4.3. All purchase orders shall be governed exclusively by the terms of
this Agreement. Any term or condition in any purchase order, confirmation,
invoice or other document furnished by APP or MDCO that is in any way
inconsistent with the terms and conditions of this Agreement shall be null and
void, unless specifically and mutually agreed upon in a writing signed by each
Party.
SECTION 2.5. Batch Quantities. Unless otherwise mutually agreed upon by the
Parties, the Initial

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Product Forecast and all Detailed Product Forecasts and purchase orders for
Product hereunder shall be for Batch Quantities or Partial Batch Quantities. To
the extent actual batch sizes manufactured by APP consist of more or less than
the applicable number of Product units specified in the definition of “Batch
Quantity,” the quantities of actual Product units contemplated by the applicable
purchase orders will be automatically adjusted to reflect the actual batch sizes
manufactured by APP.
SECTION 2.6. Shipment. Product ordered by MDCO hereunder will be shipped to MDCO
or its designee EXW (Incoterms 2000) the facility of APP, in Bensenville,
Illinois, via the carrier designated by MDCO. For avoidance of doubt, all costs
and risk of loss shall pass to MDCO upon the loading and transfer of Product to
MDCO's designated carrier at APP's facility.
SECTION 2.7. Performance by Affiliates. Notwithstanding any other provision of
this Agreement, any right or obligation of APP hereunder may be exercised or
fulfilled by any Affiliate or other designee of APP.
SECTION 2.8 Supply Interruption.     In the event that the amount of Product
ordered by MDCO pursuant to a purchase order remains undelivered to MDCO from
APP exceeds [**] percent ([**]%) of the amount of Product ordered by MDCO
pursuant to such purchase order for a period of at least [**] days, including as
may be caused by or attributed to a force majeure as set forth in Section 12.2
(a “Supply Interruption”), APP will respond promptly and in good faith to all
associated inquiries by MDCO regarding the anticipated duration of any delays
and the anticipated amount of Product to be delivered. In the event of a Supply
Interruption caused by any production capacity limitation or any shortage of
active pharmaceutical ingredient or other materials or excipients, APP shall
supply Product to MDCO on a pro rata basis based on units sold by each Party
during the preceding six-month period. In the event MDCO has not sold Product
for a continuous six-month period, APP shall supply Product to MDCO based on
[**]% of MDCO's Initial Product Forecast.
ARTICLE III
LICENSE
SECTION 3.1. Grant of License. APP hereby grants to MDCO a non-exclusive license
during the Term under the Licensed Intellectual Property only to the extent
necessary to sell, market, distribute and promote the Products solely to
hospitals and integrated delivery networks in the Territory. APP's grant of a
non-exclusive license to MDCO shall not include sales, marketing, distribution
or promotion to group purchasing organizations (“GPOs”) or wholesale
distributors for distribution or promotion to GPOs or oncology or renal clinic
distributors for subsequent distribution to their member organizations. As
consideration for the license grants set forth herein, MDCO will pay to APP, on
the Effective Date, an upfront one-time license fee for all Products, as set
forth in Exhibit D, attached hereto. Notwithstanding the foregoing, APP reserves
all other rights in the Licensed Intellectual Property not expressly licensed to
MDCO herein, including, but not limited to, the right to use or sublicense the
Marketing Authorizations to sell, market, promote and manufacture the Products.
SECTION 3.2. Marketing Authorizations Maintenance. MDCO shall deliver to APP all
information requested by APP that is necessary or useful for the purposes of APP
or its third party designee maintaining and updating the Marketing
Authorizations in accordance with FDA standards.
SECTION 3.3. MDCO Trademarks and NDC. All Product sold by MDCO shall be sold
under MDCO's own trademarks, trade names and distinct NDC. APP shall be
responsible for obtaining an NDC for each Product sold by MDCO. MDCO shall be
responsible for, all returns, rebates and chargebacks

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associated with sales of Product by MDCO; provided that APP shall be responsible
for, and shall bear the cost of, all returns and rebates associated with sales
of Product supplied not in conformity with the Product Specifications.
SECTION 3.4. Product Substitution. In the event that (i) a Product is
discontinued as set forth in Section 8.2.2, (ii) APP determines that it will no
longer sell a Product in the Territory pursuant to Section 8.2.3, or (iii) MDCO
determines that it will no longer sell the Product in the Territory pursuant to
Section 8.2.4, the Parties shall amend Exhibit C to substitute another
pharmaceutical product to replace such Product in Exhibit C according to the
following procedure: [**]. MDCO shall have [**] days to approve such a
substitution in writing. In the event that MDCO does not approve such a
substitution, the Parties shall negotiate in good faith to agree on a substitute
product.
ARTICLE IV
MANUFACTURE
SECTION 4.1. Product Manufacturing, Specifications; Quality Agreement. APP shall
manufacture, test, package and store Product in accordance with the Product
Specifications, cGMP and the Quality Agreement. Each shipment of Product
hereunder shall be accompanied by a certificate of analysis reflecting that such
Product conforms to the Product Specifications. At the time APP notifies MDCO
that any Product is available for pick-up by MDCO or its designee, such Product
shall have a minimum remaining shelf life, without retesting, of the greater of:
[**].
SECTION 4.2. Labels and Packaging. All Product supplied to MDCO hereunder shall
be packaged in accordance with the Product Specifications and cGMP and shall
include all Product labels and package inserts specified by MDCO; provided,
however, that MDCO shall provide APP or its designee with camera ready artwork
for all such labels and package inserts at least [**] days prior to the first
delivery date for the Product requiring such labels and/or such package inserts,
as specified in MDCO's purchase orders. MDCO shall be solely responsible for
ensuring that all such labels and package inserts comply with all applicable
regulatory requirements. Notwithstanding any other provision of this Agreement,
APP shall not be liable for any failure or delay to meet its obligations
hereunder to the extent such failure or delay is attributable to MDCO's failure
to supply or delay in supplying camera ready artwork in accordance herewith on a
timely basis. MDCO hereby grants APP the right and license to reproduce and
affix to Product labels and package inserts camera-ready artwork bearing the
trademarks of MDCO.
SECTION 4.3. Changes to Specifications. Subject to the remaining provisions of
this Section 4.3, the Product Specifications may be changed from time to time
(i) if required by the FDA, or (ii) upon the request of either Party and with
the consent of the other Party. The following provisions shall apply to changes
to the Product Specifications:
(a)    The Party seeking the change(s) shall promptly advise the other Party in
writing of any such change(s) to the Product Specifications, and APP shall
promptly advise MDCO as to any scheduling, price or other adjustments that may
result from such change(s), if any.
(b)    In the event of a change of the nature described in clause (i) above, the
Party seeking the change shall notify the other Party in writing promptly upon
being informed of or identifying the potential need for such change and shall
consult with the other Party on an ongoing basis regarding such change,
including the need for such potential change and the appropriate way to address
the issue giving rise to such potential change.

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(c)    Each Party shall use Commercially Reasonable Efforts to implement any
required or agreed-upon changes to the Product Specifications as soon as
practicable after the nature of the change is determined and, if applicable, the
applicable Party has consented to the change; provided, however, that in no
event shall any change be implemented until such time as such change has been
approved by the FDA, if such approval is required.
(d)    MDCO shall be responsible for, and shall promptly reimburse APP for, all
reasonable costs and expenses incurred by or on behalf of APP or its supply
contractors in connection with the implementation of changes to the Product
Specifications that are requested by MDCO or are necessary to comply with MDCO's
requests. APP shall be responsible for changes required by FDA. Additionally, if
any changes to the Product Specifications result in a change in Cost of Goods
with respect to the Product, the Purchase Prices shall be adjusted to fully
account for the amount of such change.
ARTICLE V
PRICE AND PAYMENT
SECTION 5.1. Purchase Price. During the Term, APP shall supply the Product at
the then applicable Purchase Price. The initial Purchase Prices are set forth in
Exhibit E attached hereto and shall remain firm for the 12 month period
following the Effective Date. MDCO acknowledges that the Purchase Price shall be
adjusted from time to time based on an increase or decrease in APP's actual Cost
of Goods. APP shall provide written notice to MDCO prior to the date of each
such change in the Purchase Price, setting forth in reasonable detail the change
in APP's Purchase Price in respect of each dosage strength of the Product. The
prices set forth on Exhibit E shall automatically be changed as reflected in
APP's notice, effective as of the date specified in such notice. APP represents
and warrants that the initial Purchase Prices as set forth in Exhibit E are
APP's current Cost of Goods for each of the Products based on Batch Quantities,
and that the Purchase Price for each of the Products shall remain during the
term of this Agreement APP's actual Cost of Goods for Batch Quantities and
Partial Batch Quantities.
SECTION 5.2. Invoices and Payment.
SECTION 5.2.1. All invoices from APP for Product supplied pursuant to this
Agreement shall be payable within [**] days after receipt by MDCO.
SECTION 5.2.2. All payments made to APP pursuant to this Agreement shall be made
in U.S. Dollars and paid by wire transfer of immediately available funds to an
account designated by APP in writing.
SECTION 5.3. Late Payments. Any amounts not paid by MDCO by the applicable due
date shall be subject to interest beginning on such due date, up to and
including the date on which payment is received by APP, at a rate equal to the
lesser of (a) [**] percent ([**]%) per month or (b) [**]. In each case,
applicable interest shall be calculated monthly.
SECTION 5.4. Taxes. MDCO shall pay all national, state, municipal or other
sales, use, excise, property or other similar taxes, tariffs or assessments,
assessed upon or levied against the sale of the Product (other than taxes or
charges imposed on APP's income).
ARTICLE VI
QUALITY

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SECTION 6.1. Non-Conforming Products.
SECTION 6.1.1. No later than [**] days from the date of delivery of a Product
shipment, MDCO shall examine, at its own expense, such shipment for damage,
defects or shortage and may, at MDCO's option and expense, analyze the Product
using the methods of analysis set forth in the Quality Agreement. MDCO shall
notify APP no later than [**] days from the date of delivery of Product if it
determines that any portion of a Product shipment is not in conformity with the
Product Specifications, shall furnish a sample of each allegedly non-conforming
Product lot, and provide reasonable supporting evidence that the alleged damage,
defect or shortage resulted from manufacturing, testing, storing and/or
packaging of the Product by APP and not from any mishandling during shipment.
If, within [**] business days of APP's receipt of any such notice, Product
sample(s) and reasonable supporting evidence, APP does not agree with MDCO that
such Product is non-conforming, the Parties will arrange for the lot or lots in
question to be tested by a mutually acceptable independent laboratory for
conformity with the Product Specifications, and the determination of such
laboratory will be final and binding upon the Parties. The cost of any such
testing by an independent laboratory shall be borne by the Party whose judgment
as to the conformity of any lot of the Product with the Product Specifications
proves to be incorrect. Any lots of the Product that are not in conformity with
the Product Specifications shall, at the request of APP, be destroyed by MDCO or
returned to APP for destruction or reprocessing. The cost of destroying
non-conforming Product or returning non-conforming Product to APP shall be borne
by APP if such non-conformity is determined to be the result of manufacturing,
testing, storing and/or packaging of such Product by APP and MDCO has provided
APP with the timely notice of nonconformity required by this Section 6.1.1. For
the avoidance of doubt, MDCO shall be obligated to pay in full for any rejected
shipment of Product that is subsequently found to be in conformity with the
Product Specifications.
SECTION 6.1.2. Provided MDCO provides the timely notice of nonconformity
required by this Section 6.1.1, with respect to any Product determined to be not
in conformity with the Product Specifications at the time of shipment as a
result of manufacturing, testing, storing and/or packaging by APP, APP shall
either (a) furnish conforming replacement Product in substitution of any Product
which did not conform to the Product Specifications, as soon as reasonably
practicable, or (b) if APP is unable or precluded from producing conforming
replacement Product for any reason, give MDCO full credit, or, at MDCO's
request, a full refund, for such non-conforming Product within [**] days of such
request. Except to the extent APP may otherwise have an indemnification
obligation pursuant to Section 11.1(c) in respect of any Loss attributable to
damages incurred by third parties as a result of the ingestion of Product not in
conformity with the Product Specifications and for the costs and expenses
required to be paid by APP pursuant to Section 6.2.3, if applicable, APP's sole
obligation and liability regarding Product determined to be not in conformity
with the Product Specifications as a result of manufacturing, testing, storing
and/or packaging by APP shall be as set forth in this Section 6.1.2.
SECTION 6.1.3. Notwithstanding the foregoing, to the extent non-conformity of
any Product results from any cause other than manufacturing, testing, storing
and/or packaging by APP as set forth in this Agreement, APP shall have no
liability to MDCO on the basis of this Agreement or otherwise. Without limiting
the generality of the foregoing, in the situation described in this Section
6.1.3, APP shall have no obligation to replace such Product, refund or credit
any amount paid by MDCO for such Product.
SECTION 6.2. Recall and Seizure.
SECTION 6.2.1. During the Term, the Parties shall keep each other promptly and
fully

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informed of any notification or other information, whether received directly or
indirectly, which might affect the marketability, safety or effectiveness of the
Product and/or which might necessitate a recall, or result in the seizure, of
any Product.
SECTION 6.2.2. If MDCO determines that a recall of Product may be necessary,
MDCO shall promptly inform APP of such determination. If APP determines that a
recall of Product may be necessary, APP shall promptly inform MDCO of such
determination. If either Party determines that a recall of a Product is
necessary, MDCO or its designee shall perform any required recall of Product.
APP shall use Commercially Reasonable Efforts to assist MDCO with any such
recall. APP shall use Commercially Reasonably Efforts to assist MDCO in MDCO's
investigation to determine the cause and extent of the problem giving rise to
such potential recall and in any subsequent recall of such Product.
SECTION 6.2.3. To the extent any recall or seizure results primarily from APP's
failure to manufacture, test, store and/or package the Product in accordance
with the Product Specifications or cGMP, and provided that MDCO provides APP
with written notice of such failure within [**] days of MDCO's discovery of such
failure by APP, APP shall (i) reimburse MDCO for MDCO's reasonable and
documented out-of-pocket costs and expenses incurred for such recall or in
respect of such seizure, and (ii) either:
(a)    supply Product, without additional charge, to MDCO, in an amount
sufficient to replace the amount of the Product recalled or seized; or
(b)    if APP is unable or precluded from producing conforming replacement
Product for any reason, either (i) give credit to MDCO against the Purchase
Price of Product to be delivered to MDCO in the future, in amounts equal to the
Purchase Price paid by MDCO for the Product so recalled or seized, or (ii) if
requested by MDCO, refund to MDCO the amounts paid to APP for the recalled or
seized Product.
SECTION 6.2.4. To the extent any recall or seizure results primarily from MDCO's
failure to store, distribute, promote, sell or use the Product in accordance
with the Product Specifications or cGMP, and provided that APP provides MDCO
with written notice of such failure within [**] days of APP's discovery of such
failure by MDCO, MDCO shall reimburse APP for APP's reasonable and documented
out-of-pocket costs and expenses incurred in conducting such recall or in
respect of such seizure.
SECTION 6.2.5. Except to the extent that any recall or seizure results primarily
from (i) APP's failure to manufacture, test, store and/or package the Product in
accordance with the Product Specifications or cGMP, or (ii) MDCO's failure to
store, distribute, promote, sell or use the Product in accordance with the
Product Specifications or cGMP, and the Party claiming such failure by the other
Party provides such Party with written notice of such claim of failure within
[**] days of such discovery, then the Parties shall equally share the costs
incurred by MDCO relating to any recall or seizure of the Product.
SECTION 6.2.6. For purposes of this Section 6.2 “recall” means any recall or
withdrawal or other action by MDCO to recover title to and/or possession of
Product sold or shipped to customers. For purposes of this Section 6.2,
“seizure” means any action by any government agency to seize or destroy Product
or permanently prevent release of Product.
SECTION 6.2.7. Except to the extent APP may otherwise have an indemnification
obligation

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pursuant to Section 11.1 (c) in respect of any Loss attributable to damages
incurred by third parties as a result of the ingestion of Product not in
conformity with the Product Specifications, APP's sole obligation in connection
with any recall or seizure shall be as set forth in this Section 6.2 and the
cost and expense reimbursement and credit, refund or replacement contemplated by
Section 6.2.3 shall be MDCO's sole remedy in respect of seized or recalled
Product.
SECTION 6.3. Reporting; Response to Inquiries.
SECTION 6.3.1. During the Term, each Party shall notify the other Party within
[**] days of receipt of any inquiry, complaint, claim or adverse reaction report
regarding the Product (any of the foregoing, a “Report”), including, without
limitation, any inquiry or notice from the FDA regarding any alleged regulatory
non-compliance of the Product, which notice shall describe in reasonable detail
all information contained in the Report or otherwise known to the applicable
Party regarding the subject matter thereof and shall include copies of any
documentation comprising such Report. As the Marketing Authorization holder, APP
shall comply with applicable laws, including adverse event reporting and
investigation thereof. At the request of APP, MDCO shall provide reasonable
assistance in the investigation of any claims for which MDCO has knowledge. All
contact information for each Party shall be sent to the address listed in
Section 12 (Notice) or as otherwise provided in the Quality Agreement.
SECTION 6.3.2. With respect to any inquiry of the FDA in respect of Product
manufactured by APP, APP shall (a) notify MDCO of any such inquiry directed to
APP, (b) use its Commercially Reasonable Efforts to respond fully and accurately
to all such inquiries directed to APP, (c) use its Commercially Reasonable
Efforts to assist MDCO in responding to inquiries directed to MDCO, (d) provide
the FDA with such information or data in APP's possession as the FDA requests in
connection with such inquiry or the Product, and (e) consult with MDCO regarding
APP's response to any such inquiry.
ARTICLE VII
ADDITIONAL AGREEMENTS
SECTION 7.1. Compliance with Law. APP and MDCO shall each comply with the laws,
rules and regulations applicable to the manufacture, supply, marketing and sale
of the Product. Notwithstanding the foregoing, MDCO shall be solely responsible
for, and shall bear all liability and expense relating to, all legal and
regulatory compliance required in connection with the sale, marketing and
promotion of the Product in the Territory to customers (it being agreed and
acknowledged that any decision regarding any expenditures related to such legal
and regulatory compliance shall be made by MDCO in its sole discretion). Except
as expressly set forth herein, APP shall be solely responsible for all legal and
regulatory compliance required in connection with the manufacture of the Product
(it being agreed and acknowledged that any decision regarding any expenditures
related to such legal and regulatory compliance shall be made by APP in its sole
discretion).
SECTION 7.2. Record Retention. APP shall keep and maintain all production,
control, laboratory and other records in accordance with all applicable laws,
rules and regulations, including but not limited to, those required to be
maintained by cGMP. Subject to Article X, APP shall make such records available
to MDCO and MDCO's representatives upon MDCO's reasonable request, and to the
representatives of the FDA. APP shall furnish, or permit MDCO or its
representative to make, copies of such records from time to time upon MDCO's
reasonable request. MDCO shall not disclose such copies to any third party
without APP's prior written consent, which consent shall not unreasonably be
withheld.

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SECTION 7.3. Inspections. Subject to the terms of this Section 7.3, MDCO shall
have the right to inspect such portions of APP's manufacturing facility as are
relevant to the manufacture of the Product upon [**] days' advance written
notice or on less notice if reasonably required in order to timely respond to or
comply with inquiries from or requirements imposed by the FDA. Such inspections
shall be performed during regular business hours, conducted by no more than [**]
MDCO representatives in such a manner as to minimize disruption to APP's
business operations and limited to [**] business days per inspection. All
information disclosed to or obtained by MDCO in connection with any such
inspection shall be subject to the confidentiality provisions set forth in
Article X. Such information shall not be used for any purpose other than
evaluating APP's compliance with its obligations under this Agreement and
responding to and complying with inquiries from or requirements imposed by the
FDA. Such inspections shall not occur more often than once per calendar year of
the Term, except that MDCO may perform such inspections more frequently in order
to timely respond to or comply with inquiries from or requirements imposed by
the FDA.
SECTION 7.4. Proprietary Rights. Each Party acknowledges and agrees that any and
all Intellectual Property developed, owned or used by the other Party are and
shall remain the exclusive property of that Party.
SECTION 7.5. No Sale for Resale. MDCO shall not knowingly sell any Product to
customers in the Territory for subsequent distribution or resale outside of the
Territory. Furthermore, MDCO shall not knowingly sell any Product to customers
outside the Territory for any purpose, including without limitation for
subsequent sale, distribution or resale inside the Territory.
SECTION 7.6. MDCO Promotional Efforts. MDCO shall use Commercially Reasonable
Efforts to sell, market and promote the Products in the Territory during the
Term consistent with the sale, marketing and promotion of generic pharmaceutical
products in the Territory.
ARTICLE VIII
TERM AND TERMINATION
SECTION 8.1. Term. This Agreement shall commence and be effective as of the
Effective Date and shall expire on the ten (10) year anniversary of the
Effective Date. Thereafter, the Term may be extended only by and pursuant to the
written agreement and consent of all Parties. The initial term, together with
any renewal term, is referred to herein as the “Term”.
SECTION 8.2. Termination by Either Party.
SECTION 8.2.1. Material Breach. Except with respect to (i) payment defaults by
MDCO, which shall be governed by Section 8.3, and (ii) any breach or default
arising from APP's failure to deliver or timely deliver Product in accordance
herewith, which shall be governed by Section 8.4, if either Party shall at any
time fail to discharge any of its material obligations hereunder and fail to
correct such default within ninety (90) days after the other Party has given
written notice to it thereof, or, if such default is incapable of cure within
such ninety (90) day period, fail to commence good faith action to correct such
default during such ninety (90) day period and correct such default within one
hundred twenty (120) days after the other Party has given written notice to it
thereof, then the non-breaching Party shall have the right to terminate this
Agreement immediately upon written notice to the breaching Party. This Section
8.2.1 shall not be exclusive and shall not be in lieu of any other remedies
available to a Party hereto for any breach hereunder on the part of the other
Party.
SECTION 8.2.2. Regulatory Action. Either Party may terminate this Agreement, on
a Product-

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by-Product basis, upon written notice to the other Party in the event the FDA
takes any action the result of which is to permanently prohibit the manufacture
of the Product in the Territory. Upon a termination pursuant to this Section
8.2.2, the Parties will attempt to affix responsibility for all costs associated
with outstanding or unfinished purchase orders between themselves.
SECTION 8.2.3. APP Discontinuance. APP may terminate this Agreement, on a
Product-by-Product basis, upon one hundred and eighty (180) day written notice
to MDCO in the event APP determines that it will discontinue the Marketing
Authorization for such Product in the Territory. In the event APP decides to
reintroduce a previously discontinued Product, APP will give MDCO a right of
first refusal to market and sell the Product before reintroducing such Product
in the Territory.
SECTION 8.2.4. MDCO Discontinuance. MDCO may terminate this Agreement, on a
Product-by-Product basis, upon one hundred and eighty (180) day written notice
to APP in the event the actual annual Total Market Value for a Product falls
below [**] percent ([**]%) of the Total Market Value of such Product for
calendar year 2011. “Total Market Value” to be determined from data available
from the IMS NSP or substantially similar data available from any successor
entity.
SECTION 8.2.5. Bankruptcy, Insolvency, Etc. Either Party may terminate this
Agreement immediately upon written notice to the other Party if such other Party
(i) becomes or is adjudged insolvent, (ii) makes a general assignment for the
benefit of its creditors, (iii) commences under the laws of any jurisdiction any
proceeding involving its insolvency, bankruptcy, reorganization, adjustment of
debt, dissolution, liquidation or any other similar proceeding for the release
of financially distressed debtors, (iv) has a petition filed in bankruptcy for
or against it (which, in the case of any involuntary petition, is not stayed
within sixty (60) days of being filed against it), (v) goes into liquidation
(except for the purposes of a bona fide amalgamation or other reorganization) or
(vi) has a receiver appointed over all or a significant portion of the property
or assets of that other Party.
SECTION 8.3. Termination by APP. In addition to any other remedies available to
it, APP may terminate this Agreement immediately upon written notice to MDCO if,
sixty (60) days after written notice from APP, MDCO fails to pay in full any
invoice that is past due, unless such payment is the subject of a dispute set
forth in writing by MDCO. MDCO will be solely responsible for commercializing
the Products in the Territory using its own discretion regarding marketing
strategy, positioning, pricing and other marketing and sales approaches;
provided, however, that MDCO will use commercially reasonable efforts to price,
market and sell the Products using comparable efforts to those it uses to price,
market and sell its other generic products having similar commercial value to
MDCO as the Products.
SECTION 8.4. Termination by MDCO. MDCO shall have the right to terminate this
Agreement upon written notice to APP in the event that with respect to [**]
purchase orders in a calendar year, subject to the last sentence of Section 2.5,
(a) APP has failed to supply at least the aggregate quantity of conforming
Product specified in such purchase order on or prior to the applicable delivery
date specified in such purchase orders, and (b) APP has failed to cure such
failures in accordance with Section 6.1.2.
SECTION 8.5. Survival. The following provisions shall survive the expiration or
termination of this Agreement in accordance with their respective terms:
Sections 3.3, 5.4, 7.4, 8.5, and 8.6, and Articles I, VI, IX, X XI and XII.
SECTION 8.6. Effect of Termination. Upon termination or expiration of this
Agreement, all licenses and other rights granted by the Parties hereunder and
all other rights and obligations of the Parties hereunder shall terminate except
as otherwise expressly provided herein. Termination or expiration of this
Agreement,

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in whole or in part, shall be without prejudice to the right of either Party to
receive all payments accrued and unpaid at the effective date of such
termination or expiration, without prejudice to any remedy available to either
Party in respect of any previous breach of any of the representations,
warranties or covenants herein contained and without prejudice to any other
provisions hereof which expressly or necessarily call for performance after such
termination or expiration. In the event of termination of this Agreement, APP
shall have the right (but not the obligation) to purchase all Product remaining
in the inventory of MDCO at the Purchase Prices paid by MDCO for such inventory.
APP shall exercise such right by written notice to MDCO within [**] days after
termination of this Agreement. If APP does not exercise its right to purchase
such remaining inventory, MDCO shall have the right to sell such remaining
inventory subject to the terms and conditions that would have applied to such
sale if it had occurred during the Term.
ARTICLE IX
REPRESENTATIONS AND WARRANTIES
SECTION 9.1. Representations and Warranties of APP. APP represents and warrants
to MDCO as follows:
SECTION 9.1.1. Organization. APP is a corporation duly organized and validly
existing under the laws of the State of Delaware.
SECTION 9.1.2. Corporate Power. APP has the requisite corporate authority to
execute and deliver this agreement and to perform its obligations hereunder.
SECTION 9.1.3. Compliance with Law. Any Products delivered by APP to MDCO shall,
at the time of shipment have been manufactured, packaged, stored and shipped by
APP in conformity with cGMP, Product Specifications, the Quality Agreement and
any other applicable laws, and shall not be adulterated, misbranded or otherwise
violative of the Act or other applicable laws.
SECTION 9.1.4. No Conflict. The execution and performance of APP's obligations
hereunder, are not and will not be in violation of or in conflict with any
material obligation it may have to any third party.
SECTION 9.1.5. No Debarment. APP is not debarred and APP has not and will not
use in any capacity the services of any person debarred under the Generic Drug
Enforcement Act of 1992. If at any time this representation and warranty is no
longer accurate, APP shall immediately notify MDCO of such fact.
SECTION 9.1.6. Permits. At APP's sole cost and expense, APP has and will
maintain throughout the Term all Marketing Authorizations related to the Product
and any other Marketing Authorizations required by law in order for APP to
execute and deliver this Agreement and to perform its obligations hereunder in
accordance with all applicable laws.
SECTION 9.2. NO ADDITIONAL WARRANTIES. THE LIMITED REPRESENTATIONS AND
WARRANTIES SET FORTH IN SECTION 9.1 ARE APP'S SOLE REPRESENTATIONS AND
WARRANTIES WITH RESPECT TO THE PRODUCT OR ANY OTHER SUBJECT MATTER HEREOF AND
ARE GIVEN IN LIEU OF, AND APP SPECIFICALLY DISCLAIMS, ANY AND ALL OTHER
REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, TITLE, NONINFRINGEMENT OR
SUITABILITY FOR A PARTICULAR PURPOSE.

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SECTION 9.3. Representations and Warranties of MDCO. MDCO represents and
warrants to APP as follows:
SECTION 9.3.1. Organization. MDCO is a corporation duly organized and in good
standing under the laws of the State of Delaware.
SECTION 9.3.2. Corporate Power. MDCO has the requisite corporate authority to
execute and deliver this Agreement and to perform its obligations hereunder.
SECTION 9.3.3. No Conflict. The execution and performance of MDCO's obligations
hereunder, are not and will not be in violation of or in conflict with any
material obligations it may have to any third party.
SECTION 9.3.4. No Debarment. MDCO is not debarred and MDCO has not and will not
use in any capacity the services of any person debarred under the Generic Drug
Enforcement Act of 1992. If at any time this representation and warranty is no
longer accurate, MDCO shall immediately notify APP of such fact.
SECTION 9.3.5. Permits. MDCO has and will maintain throughout the term of this
Agreement all Marketing Authorizations as required by law in order for MDCO to
execute and deliver this Agreement and to perform its obligations hereunder in
accordance with all applicable laws.
SECTION 9.3.6. Compliance with Law. Any sale, marketing, promotion or
distribution by MDCO of the Products shall not be violative of the Act or other
applicable laws.
SECTION 9.4. NO ADDITIONAL WARRANTIES. THE LIMITED REPRESENTATIONS AND
WARRANTIES SET FORTH IN SECTION 9.3 ARE MDCO'S SOLE REPRESENTATIONS AND
WARRANTIES WITH RESPECT TO THE PRODUCT OR ANY OTHER SUBJECT MATTER HEREOF AND
ARE GIVEN IN LIEU OF ANY AND ALL OTHER REPRESENTATIONS OR WARRANTIES, WHETHER
EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, TITLE, NONINFRINGEMENT OR SUITABILITY FOR A PARTICULAR PURPOSE.
ARTICLE X
CONFIDENTIALITY
In consideration for and as a condition to the Parties furnishing to one another
access to Confidential Information, the Parties agree as follows:
SECTION 10.1. The Party receiving the other Party's Confidential Information
(the “Receiving Party”) acknowledges the confidential and proprietary nature of
the Confidential Information, agrees to hold and keep the same as provided in
this Agreement.
SECTION 10.2. The Receiving Party agrees that the disclosure of Confidential
Information will be made to it in confidence and that:
SECTION 10.2.1. The Receiving Party agrees to keep Confidential Information as
confidential and secret.
SECTION 10.2.2. The Receiving Party agrees to restrict access to the
Confidential

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Information to its employees and representatives to whom such disclosure is
necessary to further the purpose of this Agreement solely on a need-to-know
basis and shall ensure that such Persons treat such Confidential Information in
a manner consistent with the terms of this Article X. The Receiving Party shall
be liable for failure of its employees and representatives to treat such
Confidential Information in a manner consistent with the terms of this Article
X.
SECTION 10.2.3. The Receiving Party agrees to notify the Party disclosing any
Confidential Information (the “Disclosing Party”) in writing of any misuse or
misappropriation of the Confidential Information which may come to its
attention.
SECTION 10.2.4. The Receiving Party may disclose the Confidential Information to
the extent such disclosure is required by law or by court, provided, however,
the Receiving Party shall provide prompt written notice to the Disclosing Party
of such requirement so that the Disclosing Party may seek a protective order or
other appropriate remedy. In the event that no such protective order or other
remedy is obtained, the Receiving Party agrees to disclose only that portion of
the Confidential Information that the Receiving Party is legally compelled or is
otherwise required to disclose; provided, however, that the Receiving Party
shall exercise all reasonable efforts to obtain confidential treatment for such
Confidential Information.
SECTION 10.2.5. The Receiving Party agrees to use the Confidential Information
only in connection with the purpose of this Agreement.
SECTION 10.2.6. Upon written request of the Disclosing Party or the termination
of this Agreement, the Receiving Party shall, at the Receiving Party's
discretion, promptly either destroy all Confidential Information and any and all
photocopies, tapes or other forms of subject material transcribed by the
Receiving Party and notify the Disclosing Party of such destruction, or return
all Confidential Information to the Disclosing Party, as the case may be;
provided, however, that the Receiving Party shall have the right to retain one
copy of any Confidential Information solely for the purpose of and to the extent
necessary to comply with legal requirements.
SECTION 10.2.7. The Receiving Party agrees that any and all Confidential
Information disclosed to the Receiving Party or its Affiliates in preliminary
discussions or agreements with the Disclosing Party prior to the execution and
delivery of this Agreement shall be subject to all the terms and conditions of
this Article X to the same extent and as fully as if this Agreement had been in
full force and effect on the date such Confidential Information was obtained by
the Receiving Party or its Affiliates, or their employees or representatives.
SECTION 10.2.8. The Receiving Party agrees that the obligations of the Receiving
Party set forth in this Article X are necessary and reasonable in order to
protect the Disclosing Party and its business.
SECTION 10.3. Anything to the contrary herein notwithstanding, the
confidentiality obligations set forth in this Article X shall survive the
expiration or termination of this Agreement for a period [**] years following
such expiration or termination.
SECTION 10.4. Publicity. All publicity, press releases and other announcements
relating to this Agreement or the transactions contemplated hereby shall be
reviewed in advance by, and shall be subject to the written approval of, both
Parties, such approval not to be unreasonably withheld or delayed.
Notwithstanding the foregoing, each Party shall be entitled to make such
announcements relating to this Agreement as such Party reasonably determines is
required to comply with any law or regulation requiring

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such announcements, including any applicable rule or regulation of any
securities exchange on which the applicable Party's (or its Affiliate's)
securities are listed.
ARTICLE XI
INDEMNIFICATION: CONTROL OF LITIGATION
SECTION 11.1. Indemnification by APP. APP shall indemnify and hold harmless MDCO
and its Affiliates and their respective officers, directors and employees
(collectively, the “MDCO Parties”) against any and all losses, liabilities,
damages, costs and expenses, including without limitation reasonable attorneys'
fees and expenses (collectively, “Losses”), sustained by a MDCO Party to the
extent arising out of or from: (a) APP's breach of its representations,
warranties, covenants or other obligations under this Agreement; or (b) gross
negligence or willful misconduct of any APP Party or their respective agents or
contractors (other than MDCO and its Affiliates); or (c) use in or by a patient
of Product manufactured, stored and/or packaged by APP in a manner that does not
conform with APP's obligations under this Agreement, except in each case to the
extent any such Loss arises out of the breach, gross negligence or willful
misconduct of a MDCO Party; or (d) any withdrawal, recall, or seizure of the
Product, to the extent such event is primarily caused by APP's breach of its
obligations in this Agreement, except in each case to the extent any such Loss
arises out of the material breach, gross negligence or willful misconduct of a
MDCO Party.
SECTION 11.2. Indemnification by MDCO. MDCO shall indemnify and hold harmless
APP and its Affiliates and their respective officers, directors and employees
(collectively, the “APP Parties”) against any and all Losses sustained by any
APP Party to the extent arising out of or from: (a) the use of Product stored,
distributed, marketed, promoted, sold or used by MDCO in a manner that does not
conform with MDCO's obligations under this Agreement, except in each case to the
extent any such Loss arises out of the breach, gross negligence or willful
misconduct of an APP Party; or (b) MDCO's breach of its representations,
warranties, covenants or other obligations under this Agreement; or (c) gross
negligence or willful misconduct of any MDCO Party or their respective agents or
contractors (other than APP and its Affiliates); or (d) any withdrawal, recall,
or seizure of the Product, to the extent such event is primarily caused by
MDCO's breach of its obligations in this Agreement,, except in each case to the
extent any such Loss arises out of the material breach, negligence or willful
misconduct of a APP Party.
SECTION 11.3. Indemnification Procedures. Promptly after receipt by a Party of
notice of any claim which could give rise to a right to indemnification pursuant
to Section 11.1 or 11.2, such Party (the “Indemnified Party”) shall give the
other Party (the “Indemnifying Party”) written notice describing the claim in
reasonable detail. The failure of an Indemnified Party to give notice in the
manner provided herein shall not relieve the Indemnifying Party of its
obligations under this Article XI, except to the extent that such failure to
give notice materially prejudices the Indemnifying Party's ability to defend
such claim. The Indemnifying Party shall have the right, at its option, to
compromise or defend, at its own expense and by its own counsel, any such matter
involving the asserted liability of the Indemnified Party. If the Indemnifying
Party shall undertake to compromise or defend any such asserted liability, it
shall promptly (and in any event not less than [**] business days after receipt
of the Indemnified Party's original notice) notify the Indemnified Party in
writing of its intention to do so, and the Indemnified Party agrees to cooperate
fully with the Indemnifying Party and its counsel in the compromise or defense
against any such asserted liability. All reasonable costs and expenses incurred
in connection with such cooperation shall be borne by the Indemnifying Party. If
the Indemnifying Party elects not to compromise or defend the asserted liability
or fails to notify the Indemnified Party of its election to compromise or defend
as herein provided, then the Indemnified Party shall have the right, at its
option, to pay, compromise or defend such asserted liability by its own counsel
and its reasonable costs and expenses shall be included as part of the
indemnification obligation of the Indemnifying Party hereunder. Notwithstanding
the foregoing, neither the Indemnifying

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Party nor the Indemnified Party may settle or compromise any claim over the
objection of the other; provided, however, that consent to settlement or
compromise shall not be unreasonably withheld. Anything to the contrary
notwithstanding, regardless of which Party controls the defense of an asserted
liability, the other Party shall have the right, at its own expense, to
participate in (but not control) such defense. If the Indemnifying Party chooses
to defend any claim, the Indemnified Party shall make available to the
Indemnifying Party copies of any books, records or other documents within its
control that are reasonably necessary for such defense. Notwithstanding anything
to the contrary in this Section 11.3, the Party conducting the defense of a
claim shall keep the other Party informed on a reasonable and timely basis as to
the status of the defense of such claim (but only to the extent such other Party
is not participating jointly in the defense of such claim). To the extent
desirable and appropriate, in connection with the defense of any liability
described in this Section 11.3, the Parties shall enter into a joint defense and
privilege agreement in customary form.
SECTION 11.4. Indemnification Payment. Upon the determination of liability and
the amount of the indemnification payment under this Article XI, the appropriate
Party shall pay to the other, as the case may be, within [**] business days
after such determination, the amount of any claim for indemnification made
hereunder.
SECTION 11.5. LIMITATION OF LIABILITY. APP'S AND MDCO'S LIABILITY IN CONNECTION
WITH THIS AGREEMENT AND THE SUBJECT MATTER HEREOF IS SUBJECT TO THE FOLLOWING
LIMITATION: IN NO EVENT SHALL APP OR MDCO BE LIABLE TO THE OTHER PARTY FOR ANY
MULTIPLE, SPECIAL, PUNITIVE, INDIRECT, CONSEQUENTIAL OR INCIDENTAL DAMAGES OF
ANY NATURE, INCLUDING WITHOUT LIMITATION LOST PROFITS.
SECTION 11.6. FOR THE AVOIDANCE OF DOUBT, THE INDEMNIFICATION PROVISIONS SET
FORTH IN THIS ARTICLE XI SHALL APPLY TO CLAIMS OF THE PARTIES HERETO, AS WELL AS
THIRD PARTY CLAIMS ASSERTED AGAINST THE PARTIES.
SECTION 11.7. Insurance. Throughout the Term and five (5) years thereafter, MDCO
shall maintain comprehensive general business liability insurance coverage, with
minimum limits of $10,000,000 per occurrence and $10,000,000 annual aggregate of
all claims. In addition, during the Term and five (5) years thereafter, MDCO
shall maintain product liability insurance coverage, with minimum limits of
$10,000,000 per occurrence and $10,000,000 annual aggregate of all claims. MDCO
shall name APP an additional insured under the policies described in this
Section 11.7.
ARTICLE XII
MISCELLANEOUS PROVISIONS
SECTION 12.1. Notices. All notices, consents or approvals required by this
Agreement shall be in writing sent by express delivery service, or by certified
or registered air mail, postage prepaid, or by confirmed facsimile to the
Parties at the following addresses or such other addresses as may be designated
in writing by the respective Parties:

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If to MDCO:
The Medicines Company
8 Sylvan Way
Parsippany, New Jersey 07054
Attn: General Counsel
Fax: (862) 207-6062

If to APP:
APP Pharmaceuticals, LLC
1501 East Woodfield Road
Suite 300 East
Schaumburg, Illinois 60173
Attn: General Counsel
Fax: (847) 413-2670

Notices shall be deemed effective on the date of receipt if sent by mail, and on
the date of transmission if sent by confirmed facsimile.
SECTION 12.2. Force Majeure. Except as otherwise provided in this Agreement, a
Party shall not be liable for nonperformance or delay in performance (other than
of obligations regarding payment of money or confidentiality) caused by any
event reasonably beyond the control of such Party including, but not limited to,
wars, acts of terrorism, hostilities, revolutions, riots, civil commotion,
national emergency, losses or shortages of power, strikes, lockouts, labor
stoppages, epidemics, fire, flood, earthquake, force of nature, explosion,
embargo, or any other act of God, loss of product in transit, shortage of or
inability to obtain material, equipment or transport, any law, proclamation,
regulation, ordinance, or other act or order of any court, government or
governmental agency or by any other supervening circumstances, which are, in
each case, beyond the reasonable control of the party so affected. If a force
majeure event occurs, the Party affected shall immediately notify the other
Party and take all reasonable steps to reduce the effect of the event. If the
force majeure event continues for a period of ninety (90) days or more, the
Party not suffering the event shall be entitled to terminate this Agreement
provided such event is continuing at the date of termination.
SECTION 12.3. Governing Law. This Agreement shall be governed by and construed
in accordance with the laws of the State of Delaware without regard to the
conflicts of laws provisions thereof. All Parties hereby consent to, and will
not dispute or contest, the jurisdiction and venue of the federal and state
courts of the State of Delaware, for purposes of any action or proceeding to
enforce the terms and conditions of this Agreement.
SECTION 12.4. Waiver; Remedies. Any term or provision of this Agreement may be
waived at any time by the Party entitled to the benefit thereof by a written
instrument executed by such Party. No delay on the part of any Party in
exercising any right, power or privilege hereunder shall operate as a waiver
thereof, nor shall any waiver on the part of any Party of any right, power or
privilege hereunder operate as a waiver of any other right, power or privilege
hereunder nor shall any single or partial exercise of any right, power or
privilege hereunder preclude any other or further exercise thereof or the
exercise of any other right, power or privilege hereunder.
SECTION 12.5. Severability. The provisions of this Agreement are separate and
independent covenants, and it is agreed that the invalidity or unenforceability
of one or more of the provisions hereof shall not invalidate any other provision
hereof, and this Agreement shall thereafter continue in full force and
effect.    In the event that any provision of this Agreement is found to be too
broad, invalid or unenforceable by any court of competent jurisdiction, then
such court shall have the authority to reform any such provisions as shall be
necessary to make the provisions valid and enforceable; provided, however, that
if the provision is not capable of being reformed, then that invalid or
unenforceable provision shall be deemed deleted as though it had never existed.

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SECTION 12.6. Independent Contractors. The Parties hereto are independent
contractors, and nothing contained in this Agreement shall be deemed to create
the relationship of partners, affiliates, joint venturers, or of principal and
agent, franchisor and franchisee, or of any association or relationship between
the Parties other than as expressly provided in this Agreement. APP acknowledges
that it does not have, and APP has not made, and shall not make, representations
to any third party, either directly or indirectly, indicating that APP has any
authority to act for or on behalf of MDCO or to obligate MDCO in any way
whatsoever. MDCO acknowledges that it does not have, and it has not made, and
shall not make, any representations to any third party, either directly or
indirectly, indicating that it has any authority to act for or on behalf of APP
or to obligate APP in any way whatsoever.
SECTION 12.7. Successors and Assigns; Assignment. This Agreement shall be
binding upon and shall inure to the benefit of the Parties hereto and their
respective successors and permitted assigns; provided, however, that MDCO may
not assign any of its rights, duties or obligations hereunder, or sublicense the
license granted to it pursuant to Article III, without the prior written consent
of APP, which consent may be withheld for any reason or no reason. The above
notwithstanding, MDCO shall be entitled, without prior written consent of APP,
to assign all or any of its rights or obligations under this Agreement to an
Affiliate or, with APP's written consent (which shall not be unreasonably
withheld), transfer such rights and obligations to a successor entity by way of
merger or acquisition of substantially all of the assets of MDCO (whether by
consolidation, sale of assets, or otherwise); provided the Affiliate or other
successor entity expressly assumes in writing those rights, duties and
obligations under this Agreement and this Agreement itself and the Affiliate or
other successor is a financially capable business entity.
SECTION 12.8. Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be considered an original and all of which
taken together shall constitute one instrument.
SECTION 12.9. Entire Agreement. This Agreement, including all Exhibits attached
hereto and the Quality Agreement, constitute the entire understanding of the
Parties with respect to the subject matter hereof, and supersedes all prior
contracts, agreements and understandings between the Parties. In case of
conflict, the prevailing order of documents shall be this Agreement and then the
Quality Agreement, except in matters pertaining to product quality, GMP and
regulatory responsibilities, in which case the Quality Agreement will prevail.
SECTION 12.10. No Third-Party Rights. Except as expressly set forth in this
Agreement, no provision of this Agreement shall be deemed or construed in any
way to result in the creation of any rights or obligation in any Person not a
Party or not an Affiliate of a Party to this Agreement.
SECTION 12.11. Amendment. This Agreement may be modified or amended only by
written agreement signed by both Parties.
SECTION 12.12. Captions. All section titles or captions contained in this
Agreement or in any Exhibit annexed hereto, and the table of contents, if any,
to this Agreement are for convenience only, shall not be deemed a part of this
Agreement and shall not affect the meaning or interpretation of this Agreement.
SECTION 12.13. Attachments. All Exhibits and other attachments to this Agreement
are by this reference incorporated herein and made a part of this Agreement.
SECTION 12.14. Expenses. Except as otherwise set forth herein, all expenses,
including the fees, if any, incurred by any attorneys, accountants or other
consultants engaged by a Party in connection with this Agreement and the
transactions contemplated hereby, shall be paid by the Party incurring such
expenses.

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[SIGNATURE PAGE FOLLOWS]

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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the
date first written above.

 
THE MEDICINES COMPANY
 
 
APP PHARMACEUTICALS, LLC
By:

__/s/ Glenn Sblendorio__________
 
By:

__/s/ J.R. Ducker__________
Name:

____ Glenn Sblendorio __________
 
Name:

____ J.R. Ducker__________
Title:

_____EVP & CFO___________
 
Title:

____President & CEO_____
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 

[Signature page to License and Supply Agreement]

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Exhibit A

Product Quantity
APP Product
#
Product Description
Batch Quantity (units)
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Exhibit B

Marketing Authorizations
APP Product
#
Product Description
ANDA Holder
ANDA Number
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Exhibit C

APP Product
#
Product Description
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Exhibit D

Upfront One-Time License Fee

$30,000,000.00 (USD)

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Exhibit E
Description
MDCO Unit Cost USD
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