Document:

MDCO EX 10.2 03.31.2012

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

	Exhibit 10.2

LICENSE AGREEMENT

BY AND AMONG

THE MEDICINES COMPANY 

AND

APP PHARMACEUTICALS, LLC AND APP PHARMACEUTICALS, INC.

DATED AS OF JANUARY 22, 2012

    

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this “Agreement”) is entered into as of January 22, 2012 (the “Effective Date”) by and between, on the one hand The Medicines Company, a company organized and existing under the laws of the State of Delaware with offices located at 8 Sylvan Way, Parsippany, New Jersey 07054 and its Affiliates (collectively, “MDCO”), and, on the other hand, APP Pharmaceuticals, LLC, a limited liability company organized and existing under the laws of the State of Delaware with offices at 1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 60173 and its Affiliates, and APP Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware with offices at 1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 60173 and its Affiliates, (collectively, “APP”).  MDCO and APP are collectively referred to herein as the “Parties,” or each individually as a “Party.”
  
R E C I T A L S:
WHEREAS, MDCO is the owner of NDA (as defined below) No. 20-873, which was approved by the FDA (as defined below) for the Manufacture (as defined below) and sale of Angiomax (as defined below); 
WHEREAS, APP Pharmaceuticals, LLC submitted Abbreviated New Drug Application No. 90-189 (together with any amendments, supplements, or other changes thereto, the “APP ANDA”) to the FDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §355(j)) seeking approval to engage in the manufacture, use and sale of the bivalirudin for injection product that is the subject of the APP ANDA (the “APP Product”);
WHEREAS, APP subsequently amended the APP ANDA to include a “paragraph IV certification” seeking approval to engage in the manufacture, use and sale of the APP Product (as defined below) prior to the expiration of United States Patent Nos. 7,582,727 and 7,598,343 (the “Litigated Patents”);
WHEREAS, APP admits that the APP Product infringes the Litigated Patents and that the Litigated Patents are valid and enforceable;
WHEREAS, MDCO and APP are parties to a certain Settlement Agreement of even date herewith (the “Settlement Agreement”), pursuant to which MDCO and APP are settling pending litigation; and
WHEREAS, pursuant to the Settlement Agreement, MDCO and APP have agreed to enter into this Agreement.
NOW THEREFORE, in consideration of the foregoing premises, the mutual covenants and agreements described herein and in the Settlement Agreement, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
1.Definitions.  Capitalized terms used, but not defined herein, shall have the meanings ascribed to them in the Settlement Agreement.

1.1“'404 Patent” means U.S. Patent No. 5,196,404.

1.2“Accelerated Launch Date” means the earlier of: [**].

1.3“Affiliate” means a Person that controls, is controlled by or is under common control with a Party.  For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one 

or more intermediaries, to direct the management and policies of such Person, whether by the ownership of fifty percent (50%) or more of the voting interest of such Person (it being understood that the direct or indirect ownership of a lesser percentage of such interest shall not necessarily preclude the existence of control), or by contract or otherwise. 

1.4“AG Product” means a generically Labeled lyophilized product containing the Compound that is Marketed and/or supplied under MDCO's NDA, described therein now or hereafter.

1.5“AG Supply Agreement” shall have the meaning assigned to such term in the Settlement Agreement.

1.6“Agreement” shall have the meaning assigned to such term in the preamble to this Agreement.
1.7“ANDA” means an Abbreviated New Drug Application submitted to the FDA for approval to Manufacture and/or Market and/or import a pharmaceutical product in or for the Territory.

1.8“Angiomax” means any pharmaceutical product which is approved for Marketing in the Territory pursuant to MDCO's NDA; provided that Angiomax shall not include a product containing an active pharmaceutical ingredient in addition to the Compound.

1.9“Anticipated Launch Date” means May 1, 2019.

1.10“APP” shall have the meaning assigned to such term in the preamble to this Agreement.

1.11“APP AG Product” means AG Product supplied to APP pursuant to the AG Supply Agreement.

1.12“APP AG Product Gross Profits” means the Net Sales for APP AG Product less the APP AG Product Manufacturing Costs. 

1.13“APP AG Product Manufacturing Costs” for APP AG Product shall mean, respectively, [**].

1.14“APP ANDA” shall have the meaning assigned to such term in the Recitals, [**].

1.15“APP Attorney or Agent” shall have the meaning assigned to such term in Section 3.7.

1.16“APP AG Launch Date” means any of the following dates:

1.16.1[**];

1.16.2[**]; and 

1.16.3[**].

1.17“APP Launch Date” means the earlier of:

1.17.1[**];

1.17.2[**];
 
1.17.3[**]; and 

1.17.4[**].

1.18“APP Liability” shall have the meaning assigned to such term in Section 7.2.

1.19“APP Party” shall have the meaning assigned to such term in Section 7.1.

1.20“APP Product” means any product which is the subject of the APP ANDA, [**].

1.21“Applicable Law” means the applicable Laws, rules, regulations, guidelines and requirements of any Governmental Authority related to the development, registration, Manufacture, Marketing or importation of the APP Product in or for the Territory or the performance of either Party's obligations under the Settlement Documents.

1.22“[**]” means the [**].

1.23“[**]” means the [**].

1.24“Authorized AG Product” means an AG Product: (i) authorized, whether pursuant to a license, supply arrangement, covenant not to sue, release, waiver or the like, for Marketing pursuant to an agreement between MDCO and a Third Party; [**].  

1.25“Authorized Generic ANDA Product” means [**].

1.26“Authorized Launch Date” means the [**]. 

1.27“Business Day” means any day other than a Saturday, Sunday or a day on which banks in New York, New York are authorized or required by Law to close.

1.28“Claim” means any Third Party claim, lawsuit, investigation, proceeding, regulatory action or other cause of action. 

1.29“Commercially Reasonable Efforts” means efforts and diligence in accordance with the subject Party's reasonable and sound business, legal, medical and scientific judgment and in accordance with the efforts and resources such Party would use in other aspects of its business that have similar commercial value and market potential, taking into account the competitiveness of the marketplace, the business life-cycle, the proprietary position of the company and the company's profitability of the pertinent product.  

1.30“Compound” means bivalirudin.

1.31“Confidential Information” means any scientific, technical, formulation, process, Manufacturing, clinical, non-clinical, regulatory, Marketing, financial or commercial information or data relating to the business, projects, employees or products of either Party and provided by one Party to the other by written, oral, electronic or other means in connection with this Agreement.

1.32“Consent Judgment” shall have the meaning assigned to such term in the Settlement Agreement.

1.33“Covenant Not to Sue” shall have the meaning assigned to such term in Section 3.5.

1.34“[**]” means the [**].

1.35“[**]” shall have the meaning assigned to such term in Section 3.10.1.

1.36“Effective Date” shall have the meaning assigned to such term in the preamble to this Agreement.

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

1.38“Final Court Decision” means a final decision of any Federal court from which no appeal has been or can be taken (other than a petition to the United States Supreme Court for a writ of certiorari).

1.39“[**]” means [**].

1.40“First Commercial Sale” means the Shipment of commercial quantities of product for immediate commercial sale to major retail chains, major pharmaceutical wholesalers, or managed care providers in the Territory, [**].

1.41“Force Majeure” means any circumstances reasonably beyond a Party's control, including, acts of God, civil disorders or commotions, acts of aggression, fire, explosions, floods, drought, war, sabotage, embargo, utility failures, supplier failures, material shortages, labor disturbances, a national health emergency, or appropriations of property.

1.42“GAAP” means generally accepted accounting principles in effect in the United States from time to time, consistently applied.

1.43“Generic Equivalent Product” means any lyophilized pharmaceutical product containing the Compound as its sole active ingredient which is submitted to the FDA for Regulatory Approval pursuant to an ANDA as a Therapeutic Equivalent to Angiomax. 

1.44“Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of:  (i) any government of any country; or (ii) a federal, state, province, county, city or other political subdivision thereof.

1.45“IMS Data” means the use and prescription data available from IMS Health Incorporated or substantially similar data available from any successor entity.

1.46“Label” means any Package labeling designed for use with a product, including the package insert for such product that is approved by the FDA, and “Labeled” or “Labeling” shall have the correlated meaning.

1.47“Launch” means the first Shipment of APP Product by APP to an unaffiliated Third Party.

1.48“Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders, judgments and/or ordinances of any Governmental Authority.

1.49“License and Authorization” shall have the meaning assigned to such term in Section 2.2.

1.50“Litigated Patents” shall have the meaning assigned to such term in the Recitals.

1.51“Losses” means any liabilities, damages, costs or expenses, including reasonable attorneys' fees and expert fees, incurred by any Party that arises from any claim, lawsuit or other action by a Third Party.

1.52“Manufacture” means all activities related to the manufacturing, development and use of a pharmaceutical product, or any ingredient thereof, including, manufacturing Compound or supplies for development, manufacturing a product for commercial sale, packaging, in-process and finished product testing, 

release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, ongoing stability tests and regulatory activities related to any of the foregoing, and “Manufactured” or “Manufacturing” shall have the correlated meaning.

1.53“Market” means to distribute, promote, advertise, market, offer for sale or sell, to a Third Party, and “Marketing” or “Marketed” shall have the correlated meaning.

1.54“MDCO” shall have the meaning assigned to such term in the preamble to this Agreement.

1.55“MDCO Liability” shall have the meaning assigned to such term in Section 7.1.

1.56“MDCO Party” shall have the meaning assigned to such term in Section 7.2.

1.57 “MDCO's External Auditor” shall have the meaning assigned to such term in 5.7.

1.58“MDCO's NDA” means MDCO's NDA No. 20-873, as amended, or supplemented, for the Regulatory Approval of Angiomax.

1.59“MDCO's Patents” means: (i) the Litigated Patents and any patent that issues as a result of a continuation, continuation-in-part, divisional, reexamination or reissue thereof; and (ii) except for the '404 Patent, any other present or future U.S., international, or foreign patent owned, licensed or controlled by MDCO or any of its Affiliates which claims cover the Manufacturing, Marketing, using, or importing of the APP Product or APP AG Product.  [**]. 

1.60“Net Sales” shall equal the gross amount invoiced for sales of the APP AG Product by APP to Third Parties in the Territory less the following, deductions from such gross sales, all as determined in accordance with APP's standard practices for other pharmaceutical products and consistent with the customary practices in the generic pharmaceutical industry in the Territory, consistently applied, and which, as applicable, are actually incurred, allowed, accrued or specifically allocated.  For the sake of clarity, all such deductions represent reductions to the gross amount invoiced for sales of the APP AG Product by APP to Third Parties in the Territory in accordance with GAAP: 

1.60.1[**] percent ([**]%) of gross sales for cash discounts;

1.60.2reasonable estimates for chargebacks, rebates, administrative fee arrangement and similar price concessions offered to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations, other institutions or health care organizations or other customers directly related to the sale of APP AG Product;

1.60.3reasonable estimates for customer returns of APP AG Product (including as a result of recalls);

1.60.4reasonable estimates for rebates or other price reductions provided, based on sales of APP AG Product to any governmental or regulatory authority in respect of state or federal Medicare, Medicaid or similar programs; and

1.60.5reasonable estimates for billing adjustments, price or shelf stock adjustments, or other promotional allowances.

1.61“NDA” means a New Drug Application (or equivalent regulatory mechanism) filed with the FDA pursuant to and under 21 U.S.C. § 355(b) (as amended, supplemented or replaced), together with the FDA's implementing rules and regulations.

1.62“Package” means all primary containers, including bottles, cartons, shipping cases or any other like matter used in packaging or accompanying a product, and “Packaged” or “Packaging” shall have the correlated meaning.

1.63“Party” or “Parties” shall have the meaning assigned to such term in the preamble to this Agreement. 

1.64“Patent Term Extension” means any extension of the patent term of the '404 Patent beyond March 23, 2010 for any reason including, but not limited to, legislative, judicial actions or action by the U.S. Patent and Trademark Office. 

1.65“Pending Appeal” shall have the meaning assigned to such term in the Settlement Agreement.

1.66“Pending Litigation” shall have the meaning assigned to such term in the Settlement Agreement.

1.67“Person” means any individual, partnership, association, corporation, limited liability company, trust, or other legal person or entity.

1.68“Regulatory Approval” means final Marketing approval by the FDA for the sale and Marketing of a pharmaceutical product in the Territory.

1.69“[**]” shall have the meaning assigned to such term in Section 2.2.

1.70“Settlement Agreement” shall have the meaning assigned to such term in the Recitals.

1.71“Settling Party” shall have the meaning assigned to such term in Section 11.5.

1.72“Shipped” means, with respect to a product, when a Person has delivered shipments of such product to a common carrier for shipment to its customers for resale; in each instance, a “Shipment,” “Ship” or “Shipping” shall have the correlated meaning.

1.73“[**]” means [**]. 

1.74“Term” shall have the meaning assigned to such term in Section 10.1.

1.75“Territory” means the United States of America, and its territories, commonwealths, districts and possessions, including the Commonwealth of Puerto Rico.

1.76“Therapeutic Equivalent” shall have the meaning given to it by the FDA in the current edition of the “Approved Drug Products with Therapeutic Equivalence Evaluations” (a/k/a the “Orange Book”) as may be amended from time to time during the Term.

1.77“Third Party” or “Third Parties” means any Person or entity other than a Party or its Affiliates.

1.78“Third Party License” shall have the meaning assigned to such term in Section 3.10.1.

2.License and Authorization

2.1Subject to the terms, conditions and limitations hereof, including the conditions set forth in 

Section 3, MDCO hereby grants to APP a non-exclusive license (except as provided in Section 2.2), under MDCO's Patents to: (i) Manufacture, have Manufactured, import and Market the APP Product in or for the Territory, on and after the applicable APP Launch Date; (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding APP Product prior to the APP Launch Date (but not to Market (except as provided in Section 3.1) or Ship the APP Product prior to the APP Launch Date) in sufficient quantities for the Launch of APP Product and to permit APP to Market and Ship the APP Product beginning on and after the APP Launch Date; and (iii) [**].  To the extent MDCO owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval of the APP Product or APP's Manufacture, importing or Marketing of APP Product in the Territory as permitted hereunder, MDCO hereby waives, effective as of the date that APP is licensed to conduct the applicable activity hereunder, such exclusivities and shall, if requested by APP and if applicable, send the FDA (within [**] Days of APP's request), a written confirmation (a copy of which shall be sent to APP prior to submission to the FDA for APP's review and comment) of MDCO's agreement to waive, effective as of the date that APP is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the APP Product and/or the APP ANDA; provided, however, that the foregoing waiver shall not apply with respect to any pediatric exclusivity attached to the '404 Patent.  

2.2The license and authorization granted in Section 2.1 of this Agreement are referred to herein as the “License and Authorization.”  Except to the extent permitted pursuant to Section 11.3, and without derogating from APP's “have Manufactured” rights set forth in Section 2.1, APP shall not have the right to sublicense, assign or transfer any of its rights under the License and Authorization.  [**].   

2.3[**].

2.4[**].

2.5Except as set forth in the License and Authorization or expressly set forth in this Agreement, there are no authorizations, licenses or rights granted by either Party under this Agreement, by implication, estoppel or otherwise, including any right granted to APP to Market or Manufacture any Generic Equivalent Product except under the APP ANDA.  Nothing herein shall be construed as the granting of any license or right to or under the '404 Patent.  All rights not expressly granted by MDCO herein are hereby retained by MDCO.  In addition, except as set forth in Section 2.2, MDCO explicitly retains the right itself or through an Affiliate to Market a generically Labeled version of Angiomax, and MDCO is free to grant a license under MDCO's Patents and/or supply AG Product to any Third Party.

3.Conditions

3.1APP hereby agrees that it shall not Market or Ship APP Product in the Territory prior to the applicable APP Launch Date.  Notwithstanding the foregoing, APP shall be permitted (i) [**] days in advance of the Anticipated Launch Date [**] to inform potential customers of the date on which APP would be permitted to sell the APP Product or APP AG Product; and (ii) [**]  days in advance of the Anticipated Launch Date [**] to engage in confidential non-binding and preliminary pricing and non-binding and preliminary contracting activities with respect to the APP Product or APP AG Product. 

3.2APP hereby agrees not to (i) challenge, or in any way support or lobby for legislation that would affect, any Patent Term Extension or the validity or enforceability of the Litigated Patents or the '404 Patent; (ii) aid, abet, assist, enable or participate with any Third Party in a challenge to, or in supporting or lobbying in any way for legislation that would affect, any Patent Term Extension or the validity or enforceability of the Litigated Patents or the '404 Patent or the non-infringement by a Generic Equivalent Product sold by a Third Party of the Litigated Patents or the '404 Patent in or for the Territory, except to the extent required by court order or other Applicable Law; (iii) Market or Manufacture a Generic Equivalent Product other than the APP Product pursuant to the License and Authorization; or (iv) aid, abet, enable or contract with any Third Party regarding the Marketing or Manufacturing of any Generic Equivalent Product in or for the Territory other than the APP Product.  [**].
          

3.3In addition to any other right or remedy MDCO may be entitled to, in the event that during the Term, APP breaches Sections 3.2 or 3.7, MDCO may, at its sole discretion, immediately, effective upon notice to APP, terminate the Settlement Documents, and/or this Agreement.

3.4Nothing set forth herein or in the other Settlement Documents shall be deemed to give MDCO any control over any Marketing exclusivity that may be granted to APP by the FDA in connection with the APP ANDA or the APP Product.  Nothing set forth herein or in the other Settlement Documents shall be deemed to prevent or restrict APP from Manufacturing or Marketing any Generic Equivalent Product which would not infringe MDCO's Patents, and nothing herein shall prohibit APP from entering into any agreement with a Third Party related to any Generic Equivalent Product that does not infringe MDCO's Patents.  

3.5MDCO hereby covenants that it will not sue, assert any claim or counterclaim against, otherwise participate in any action or proceeding against APP or its Affiliates or any of their shareholders, licensees, sublicensees, customers, suppliers, importers, manufacturers, distributors, marketing partners, insurers, or any heirs, administrators, executors, predecessors, successors, or assigns of the foregoing, or cause or authorize any person or entity to do any of the foregoing, in each case claiming or otherwise asserting that the Manufacture or use anywhere in the world for exportation into the Territory, or the Marketing, sale, offer for sale, or importation of the APP Product (and for clarity, the Compound used to Manufacture the APP Product), in or for the Territory in accordance with this Agreement, infringes MDCO's Patents (and any other United States or foreign patent issued now or in the future, except for the '404 Patent or any patent covering a ready to use patent) insofar as MDCO's Patents apply to the APP ANDA or the APP Product (the “Covenant Not to Sue”).  MDCO will impose the foregoing Covenant Not to Sue on any Third Party to which MDCO may assign, grant a right to enforce, or otherwise transfer (by any means) any of MDCO's Patents subject to the foregoing Covenant Not to Sue.  The Covenant Not to Sue shall not apply in the event APP has violated the Consent Judgment or has materially breached this Agreement or the Settlement Agreement.  For any of MDCO's Patents listed in the FDA's Orange Book, the Covenant Not to Sue will hereby be treated as a non-exclusive license, so that APP or its Affiliates may file and maintain with the FDA “Paragraph IV Certifications” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) and 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced) with respect thereto.  [**].   

3.6In consideration of the mutual execution of the Settlement Documents and the mutual agreement to be legally bound by the terms hereof, MDCO and APP, with the intention of binding themselves and their respective Affiliates, and their respective predecessors, successors, heirs and assigns, directors, officers, employees and representatives, hereby fully, finally and irrevocably release and discharge each other from any and all actions, causes of action, suits, debts, dues, sums of money, accounts, reckonings, bonds, bills, specialties, covenants, contracts, liabilities, controversies, agreements, promises, variances, trespasses, damages, judgments, extents, executions, claims, counterclaims, demands, costs, expenses, losses, liens and obligations, whatsoever, in law or equity, whether known or unknown, and waive any and all defenses, occurring before or as of the Effective Date related to the Litigated Patents, including (i) in connection with the Pending Litigation, (ii) APP's making, using, selling, offering for sale or importing Compound anywhere in the world for purposes of selling Compound to APP's customers prior to the Effective Date, (iii) associated with the APP ANDA and APP Product, and including MDCO's assertion of the Litigated Patents against APP, or (iv) all other claims that were asserted or could have been asserted in the Pending Litigation.  For purposes of clarity, nothing herein shall inhibit any Party's ability to enforce the terms of this Agreement or the Settlement Agreement; MDCO's ability to enforce any patent, including the MDCO's Patents against Third Parties, except as specifically provided in the Covenant Not to Sue; or APP's ability to challenge the infringement of any patent, including the Litigated Patents and the '404 Patent, in connection with any product or ANDA other than the APP Product and APP ANDA.  

3.7Except to the extent required by any Governmental Authority,  or Applicable Law, APP shall not release (including any oral or written release or waiver of any right) any attorney (including any of the attorneys or law firms of record in the Pending Litigation or Pending Appeal) or any agent or consultant (whether retained by APP or by any attorney that represents APP) (“APP Attorney or Agent”) to: (i) assist, or cooperate with, any Third Party (including any current or future litigant in a litigation against MDCO) with respect to a Generic Equivalent Product, the Litigated Patents, the '404 Patent, or otherwise with respect to Angiomax in the Territory, or 

(ii) [**].  APP shall not release, grant a waiver of conflict of interest or otherwise take any action which would allow or permit any APP Attorney or Agent  (i) to breach the confidentiality of non-public information to which such attorney had access in connection with the Pending Litigation or Pending Appeal; or (ii) to represent or otherwise assist any Third Party (including any current or future litigant in a litigation against MDCO) with respect to a Generic Equivalent Product, the Litigated Patents, the '404 Patent, or otherwise with respect to Angiomax in the Territory.  [**]. 

3.8[**].

3.9At the request of APP, MDCO will submit appropriate and necessary documentation to the FDA evidencing the licenses, waivers and covenants granted to APP under this Agreement.  

3.10[**].  

3.10.1[**]. 

3.10.2[**].

3.11    Following the Effective Date, the Parties agree to negotiate in good faith and work diligently to executive within [**] an agreement pursuant to which MDCO, [**], will use Commercially Reasonable Efforts to supply Compound to APP for use by APP in the Manufacture of APP Product for Marketing solely pursuant to the License and Authorization.  Except as otherwise provided or required in an agreement with a Third Party, [**].
4.Marketing of APP AG Product and APP Product

4.1During any period APP is paying a royalty under Sections 4.5 for APP AG Product, APP shall, at its sole cost and expense, utilize Commercially Reasonable Efforts in Marketing the APP AG Product in the Territory to maximize sales of APP AG Product.  During the Term prior to the APP Launch Date, APP shall not enter into any arrangements or agreements with any Third Party to Market APP Product or APP AG Product in the Territory without MDCO's prior written consent, which shall not be unreasonably withheld, except that APP shall not be restricted in entering into customary agreements with its ordinary trade customers including, wholesalers, distributors, and retailers or with suppliers and vendors of advertising, marketing and promotional services. 

4.2Except as provided in Section 11.3, only APP shall be permitted to Launch and Market APP Product or the APP AG Product under this Agreement.

4.3It is the intent of APP to seek to sell APP AG Product so as to maximize APP AG Product Gross Profits.  APP will have sole discretion, however, in setting the price for the sale of the APP AG Product in the Territory.  APP will also agree that if it prices APP AG Product in order to gain or maintain sales of other products, then for purposes of calculating the payments due hereunder, the Net Sales of such APP AG Product shall be adjusted to reverse any discount which was given to a customer that was in excess of customary discounts for the APP AG Product (or, in the absence of relevant data for this APP AG Product, other similar products under similar market conditions).

4.4Notwithstanding the above,  APP shall use Commercially Reasonable Efforts to obtain Regulatory Approval of the APP ANDA.  

4.5APP AG Product Royalty.  APP will pay to MDCO a royalty of [**] percent ([**]%) of APP AG Product Gross Profits on APP AG Product. 

4.6Royalty Payments.  Payments due under this Section 4 shall be made within [**] days from the end of each calendar quarter in which APP AG Product is sold.  All such payments shall include a report 

detailing the calculation of gross sales, Net Sales, APP AG Product Gross Profits and the royalties payable hereunder.  

4.7Annual True-Up. Within [**] days after the end of the last calendar year during the Term in which fees are payable to MDCO pursuant to this Section 4, APP shall perform a “true up” reconciliation (and shall provide MDCO with a written report of such reconciliation) of the items comprising deductions from Net Sales outlined in Sections 1.60.2, 1.60.4 and 1.60.5.  The reconciliation shall be based on actual cash paid or credits actually issued plus an estimate for any remaining liabilities incurred related to APP AG Product but not yet paid.  If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party shall pay the amount of the difference to the other Party within [**] days of the date of delivery of such report. 

4.8Final True-Up.  Within [**] months after the end of the last calendar year during the Term in which fees are payable to MDCO pursuant to this Section 4, APP shall perform a “true-up” reconciliation (and shall provide MDCO with a written report of such reconciliation) of the items comprising deductions from Net Sales for returns as outlined in Section 1.60.3.  The reconciliation shall be based on actual cash paid or credits issued for returns, through the [**] month period following the termination of the Supply Term.  If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party shall pay the amount of the difference to the other Party within [**] days of the date of delivery of such report.

4.9Maintenance of Records.  During the Term, and for a period of [**] thereafter, APP shall, and shall ensure that its Affiliates shall, keep at either its normal place of business, or at an off-site storage facility, detailed, accurate and up to date:

4.9.1records and books of account sufficient to confirm the calculation of the gross sales, Net Sales, APP AG Product Gross Profits, and the royalties payable hereunder; and 

4.9.2information and data contained in any invoices or reports accompanying any payment to MDCO provided to MDCO in connection with this Agreement.

4.10Inspection.  On no less than [**] Business Days notice from MDCO, APP shall make all the records, books of account, information and data referred to in Section 4.9 of this Agreement available for inspection during normal business hours by an internationally recognized independent accounting firm selected by MDCO and reasonably acceptable to APP that is not paid in whole or in part by a contingent fee arrangement, (“MDCO's External Auditor”) for the purpose of general review or audit; provided that MDCO may not request such inspection more than once in any calendar year.  Upon reasonable belief of discrepancy or dispute, MDCO's External Auditor shall be entitled to take copies or extracts from such records, and books of account (but only to the extent related to the contractual obligations set out in this Agreement) during any review or audit, provided MDCO's External Auditor signs a confidentiality agreement with APP providing that such records, and books of account shall be treated as Confidential Information which may not be disclosed to any Person, including MDCO.  MDCO's External Auditor shall only disclose to MDCO the results of the MDCO's External Auditor's audit, which results shall be concurrently disclosed to APP. Any underpayment or overpayment of amounts due hereunder as reflected by MDCO's External Auditor's results shall be promptly paid by the Party owing payment.  

4.11Inspection Costs.  MDCO shall be solely responsible for its costs in making any such review and audit, unless MDCO identifies a discrepancy in the calculation of royalties paid to MDCO under this Agreement in any calendar year from those properly payable for that calendar year of [**] percent ([**]%) or greater, in which event APP shall be solely responsible for the cost of such review and audit and shall pay MDCO any payment due.  All information disclosed by APP or its Affiliates pursuant to this Section 4 shall be deemed APP's Confidential Information.

4.12Payment Method.  All payments to be made by APP to MDCO under this Agreement shall 

be in United States dollars in immediately available funds and shall be made by wire transfer to the account designated by MDCO, such account to be designated by MDCO at least five (5) Business Days prior to the date any such payment is due.

4.13Late Payments. In addition to any other rights and remedies, in the event payments required to be made under this Agreement are not made on or prior to the required payment date, the amount of the late payment shall bear interest at the lesser of [**] percent ([**]%) above the prime rate reported in The Wall Street Journal (Eastern Edition) on the date such payment was due and the maximum permissible rate under the Law commencing on the date such payment is due until such date as the payment is made.

4.14Taxes.  MDCO shall be responsible for and shall pay all taxes payable on any income to MDCO or any payments by APP to MDCO.  APP and MDCO shall bear sole responsibility for payment of compensation to their respective personnel, employees or subcontractors and for all employment taxes and withholding with respect to such compensation pursuant to Applicable Law.  APP shall have the right to withhold taxes in the event that the revenue authorities in any country require the withholding of taxes on amounts paid hereunder to MDCO.  APP shall secure and promptly send to MDCO proof of such taxes, duties or other levies withheld and paid by APP for the benefit of MDCO.  Each Party agrees to cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect.

5.Confidentiality

5.1Confidentiality Obligation.  The Parties and their respective employees, directors, officers, consultants and contractors shall keep and maintain as confidential any Confidential Information supplied by the other Party during the Term.  The confidentiality and non-disclosure obligations contained in this Agreement shall not apply to the extent that, evidenced by written records or similar proof, such Confidential Information is:

5.1.1at the time of disclosure by one Party to the other, in the public domain or otherwise publicly known;

5.1.2after disclosure by one Party to the other becomes part of the public domain, or otherwise publicly known, other than by breach by a Party of any obligation of confidentiality;

5.1.3information which the receiving Party can establish by competent evidence was already in its possession at the time of receipt or was independently developed by the receiving Party; or

5.1.4received from a Third Party who was lawfully entitled to disclose such information free of an obligation of confidentiality.

5.2Exceptions.  Notwithstanding Section 5.1, in addition to any disclosure allowed under Section 11.5 the Party receiving Confidential Information may disclose such Confidential Information to the extent that such disclosure has been ordered by a court of law or directed by a Governmental Authority, provided that, the disclosure is limited to the extent ordered or directed and wherever practicable, the Party that owns the Confidential Information has been given sufficient written notice in advance to enable it to seek protection or confidential treatment of such Confidential Information.

5.3Expiration of Confidentiality.  The confidentiality obligation contained in this Section 5 shall survive the termination or expiry of this Agreement for so long as such information remains confidential.

5.4Disclosure.  If a Party is subpoenaed or otherwise requested by any Person, including any Governmental Authority, to give testimony or provide information which in any way relates to this Agreement, the APP Product or practices associated with the APP Product, such Party shall give the other Party prompt notice of 

such request, and unless otherwise required by Law, shall make no disclosure until such other Party has had a reasonable opportunity to contest the right of the requesting Person to such disclosure.  The Parties shall provide each other with all reasonable cooperation and generally make its employees available to give testimony or to provide reasonable assistance in connection with any lawsuits, claims, proceedings and investigations relating to this Agreement, the APP Product or practices associated with the APP Product.  

5.5Enforcement.  The Parties agree that equitable relief, including injunctive relief and specific performance, is appropriate in enforcing the confidentiality provisions of this Agreement.  In the event of any such action to construe this provision, the prevailing Party will be entitled to recover, in addition to any charges fixed by the court, its costs and expenses of suit, including reasonable attorney's fees.  Such remedies shall not be deemed to be the exclusive remedies for a breach of this provision, but shall be in addition to all other remedies available at law or equity.

6.Representations and Warranties of Parties
MDCO represents and warrants to APP that MDCO possess the rights and authority to grant the License and Authorization to APP and its Affiliates under this Agreement, and with respect to Sections 6.1 and 6.2 below, each of MDCO and APP represents, warrants, and covenants, to the other Party that:
6.1Organization and Authority.  Such Party is a corporation or limited liability company duly organized, validly existing and in good standing under the Laws of the jurisdiction of its formation.  Such Party has the requisite power and authority to enter into this Agreement.  Such Party has the requisite power and authority to execute and deliver this Agreement and to perform all of its obligations hereunder.  The execution and delivery of this Agreement and the performance by such Party of its obligations hereunder have been authorized by all requisite action on its part.  This Agreement has been validly executed and delivered by such Party, and, assuming that such documents have been duly authorized, executed and delivered by the other Party, constitutes a valid and binding obligation of such Party, enforceable against such Party in accordance with its terms.

6.2Consents and Approvals; No Violations. 

6.2.1Except as otherwise set forth in this Agreement or the Settlement Agreement, no material filing with, and no material permit, authorization, consent, or approval, of or from any Governmental Authority is required to be obtained by or on behalf of such Party of the transactions contemplated by this Agreement, except for those filings, permits, authorizations, consents or approvals, the failure of which to be made or obtained would not materially impair such Party's ability to consummate the transactions contemplated hereby or materially delay the consummation of the transactions contemplated hereby.

6.2.2Neither the execution nor the delivery of this Agreement by such Party, nor the performance by such Party of its obligations hereunder, will (i) violate the certificate of incorporation, certificate of formation, by-laws or other organizational document of such Party; (ii) conflict in any material respect with or result in a material violation or breach of, or constitute a material default under, any material contract, agreement or instrument to which such Party is a party; or (iii) violate or conflict in any material respect with any material Law, rule, regulation, judgment, order or decree of any court or Governmental Authority applicable to such Party, except in the case of clause (ii) or (iii) for violations, breaches or defaults which would not have a material adverse effect on such Party's ability to consummate the transactions contemplated hereby.

6.2.3The Parties shall submit this Agreement together with the Settlement Agreement to the Federal Trade Commission Bureau of Competition and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice as soon as practicable following its execution and in no event later than ten (10) Business Days following its execution.  

7.Indemnities; Product Liability; Insurance

7.1.Indemnity by MDCO.  MDCO shall defend, indemnify and hold harmless each of APP and its Affiliates and its and their directors, officers, employees and contractors (“APP Party”) from and against any and all Losses, (“MDCO Liability”) arising from or in connection with:

7.1.1any Claim resulting from any gross negligent acts or acts of willful misconduct of any MDCO Party in connection with the performance of its obligations under this Agreement; or

7.1.2any Claim based on or arising out of the use, Manufacturing, Labeling, Packaging or Marketing of Angiomax, including, any investigation by a Governmental Authority or any claim for personal injury or property damage asserted by any user of Angiomax;

7.1.3the breach by MDCO of any of its representations or warranties contained in this Agreement; 

except, in each case, to the extent that the MDCO Liability is caused by the negligence, breach of the terms of this Agreement, or willful misconduct of a APP Party.
7.2.Indemnity by APP.  APP shall defend, indemnify and hold harmless each of MDCO and its Affiliates and its and their directors, officers, employees and contractors (“MDCO Party”) from and against any and all Losses (“APP Liability”) arising from or in connection with:

7.2.1any Claim resulting from any gross negligent acts or acts of willful misconduct of any APP Party in connection with the performance of its obligations under this Agreement;

7.2.2any Claim based on or arising out of the use, Manufacturing, Labeling, Packaging or Marketing of APP Product, including, any investigation by a Governmental Authority or any claim for personal injury or property damage asserted by any user of APP Product; or

7.2.3the breach by APP of any of its representations or warranties contained in this Agreement. 

except, in each case, to the extent that APP's Liability is caused by the negligence, breach of the terms of this Agreement, or willful misconduct of a MDCO Party.
7.3.Control of Proceedings.  A Party seeking indemnification hereunder shall provide prompt written notice to the other Party (and, in any event, within thirty (30) days) of the assertion of any claim against such Party as to which indemnity is to be requested hereunder.  The indemnifying Party shall have the sole control over the defense of any Claim, provided that, the indemnifying Party shall obtain the written consent of the indemnified Party prior to settling or otherwise disposing of such Claim if as a result of the settlement or Claim disposal the indemnified Party's interests are in any way adversely affected.

7.4.No Admissions.  The indemnified Party shall not make any payment or incur any expenses in connection with any APP Liability or MDCO Liability (as the case may be), or make any admissions or do anything that may compromise or prejudice the defense of any Claim without the prior written consent of the indemnifying Party.

7.5.Claim Information.  Each Party shall promptly:

7.5.1inform the other by written notice of any actual or threatened Claim to which Sections 7.1 or 7.2 apply;

7.5.2provide to the other Party copies of all papers and official documents received in 

respect of any such Claim; and 

7.5.3cooperate as reasonably requested by the other Party in the defense of any such Claim.

7.6.Limitation of Liability.  Except as may be included in a Claim under Section 7.1, 7.2 or 7.8, or a breach by any Party of Section 3 or Section 11.5, in no event shall any Party or its Affiliates be liable for special, punitive, indirect, incidental or consequential loss or damage based on contract, tort or any other legal theory arising out of this Agreement.

7.7.Product Liability Insurance.  Each Party shall maintain, at its own cost, general commercial liability insurance (including comprehensive product liability) in such amount as MDCO and APP, respectively, customarily maintain with respect to its other products and which is reasonable and customary in the U.S. pharmaceutical industry for companies of comparable size and activities but in any event not less than $[**] per occurrence and $[**] in the aggregate.  In the event the insurance policy obtained by a Party is a “claims made” policy (as opposed to an “occurrence” policy), such Party shall obtain comparable insurance for not less than four (4) years following the expiry or termination of this Agreement.

7.8.Irreparable Harm.  APP acknowledges that in the event of a Launch or continued Marketing or Shipping by APP of APP Product or APP AG Product in the Territory other than as permitted under this Agreement, the damages to MDCO and its business (including, but not limited to, lost sales of Angiomax) would be difficult to calculate and the adequacy of monetary damages calculated at Law would be uncertain.  Accordingly, APP agrees that in any action by MDCO seeking injunctive or other equitable relief in connection with any such Launch or continued Marketing of Shipping, other than as permitted under this Agreement, APP shall not assert or plead the availability of an adequate remedy at Law as a defense to the obtaining of any such remedy.  APP hereby waives any equitable defense to such injunction including, laches, unclean hands, acquiescence or any estoppel arguments.  The foregoing shall not be in lieu of any other remedy to which MDCO may be entitled hereunder in equity or at Law as a result of such a breach.  

7.9.Limitation on Representations, Warranties and Indemnification.  NEITHER PARTY SHALL BE DEEMED TO MAKE ANY REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, EXCEPT AS SPECIFICALLY SET FORTH HEREIN.  ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED BY EACH PARTY.

8.Force Majeure

8.1Force Majeure.  Neither Party shall be entitled to terminate this Agreement or shall be liable to the other under this Agreement for loss or damages attributable to any Force Majeure, provided the Party affected shall give prompt notice thereof to the other Party.  Subject to Section 8.2, the Party giving such notice shall be excused from such of its obligations hereunder for so long as it continues to be affected by Force Majeure.

8.2Continued Force Majeure. If any Force Majeure continues unabated for a period of at least ninety (90) days, the Parties shall meet to discuss in good faith what actions to take or what modifications should be made to this Agreement as a consequence of such Force Majeure in order to alleviate its consequences on the affected Party. 

9.Trademarks and Trade Names

9.1Except as may appear on the AG Product vials, Labeling and Packaging, APP shall have no right to use any trademark or tradedress of MDCO and shall have no rights to any other intellectual property of MDCO or its Affiliates other than to the extent of the License and Authorization.

10.Term and Termination

10.1Term.  Unless sooner terminated in accordance with the terms hereof, the term of this Agreement shall extend from the Effective Date until the later of:  (i) the expiration of all of MDCO's Patents, and (ii) six (6) months after the date of expiration of the '404 Patent (the “Term”).

10.2Termination.  In addition to MDCO's right to immediately terminate this Agreement as set forth in Section 3, either Party shall be entitled to terminate this Agreement by written notice to the other if:

10.2.1the other Party commits a material breach of this Agreement, and fails to remedy it within sixty (60) days of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this Section 10.2; or 

10.2.2an order is made or a resolution is passed for the winding up of the other Party (other than voluntarily for the purposes of solvent amalgamation or reconstruction) or an order is made for the appointment of an administrator to manage the other Party's affairs, business and property or if a receiver (which expression shall include an administrative receiver) is appointed over any of the other Party's assets or undertaking or if circumstances arise which entitle the court or a creditor to appoint a receiver or manager or which entitle the court to make a winding-up order or if a voluntary arrangement is proposed in respect of the other Party or if the other Party takes or suffers any similar or analogous action in consequence of debt, and such order, appointment or similar action is not removed within ninety (90) days. 

10.3Effect of Termination.  In the event of expiry or termination of this Agreement for any reason, each Party shall promptly return all Confidential Information of the other Party provided during the Term or destroy and certify the destruction of such Confidential Information. 

10.4Liability on Termination.  The termination or expiry of this Agreement shall not release either of the Parties from any liability which at the time of termination or expiry has already accrued to the other Party, nor affect in any way the survival of any other right, duty or obligation of the Parties which is expressly stated elsewhere in this Agreement to survive such termination or expiry.

10.5Surviving Sections.  The provisions of Sections 1, 3.6, 4.7-4.14, 5, 6, 7, 10.3, 10.4, 10.5, and 11 shall continue in force in accordance with their respective terms notwithstanding expiry or termination of this Agreement for any reason.  In addition, except in the event that APP has violated the Consent Judgment or has materially breached this Agreement or the Settlement Agreement, the Covenant Not to Sue shall survive termination or earlier expiration of this Agreement.

11.Miscellaneous

11.1Notice.  

11.1.1Any notice or other document given under this Agreement shall be in writing in the English language and shall be given by hand or sent by prepaid airmail, or by confirmed fax transmission to the address of the receiving Party as set out in Section 11.2 below unless a different address or fax number has been notified to the other in writing for this purpose.

11.1.2Each such notice or document shall:

		
	i.
	if sent by hand, be deemed to have been given when delivered at the relevant address;

		
	ii.
	if sent by prepaid mail, be deemed to have been given five (5) days after posting; or 

		
	iii.
	if sent by confirmed fax transmission be deemed to have been given when transmitted, provided 

that, a confirmatory copy of such fax transmission shall have been sent by prepaid overnight mail within twenty-four (24) hours of such transmission.

11.2Address for Notice.  The address for services of notices and other documents on the Parties shall be:  
	
	
	To MDCO 
The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
Attn: Chief Executive Officer
Facsimile: (862) 207-6064                

with a copy to:

The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
Attn: General Counsel
Facsimile: (862) 207-6062

	To APP 
APP Pharmaceuticals, Inc.
1501 East Woodfield Road
Suite 300 East
Schaumburg, Illinois 60173
Attn: General Counsel
Facsimile:  (847) 413-2670

with a copy (which shall not constitute notice hereunder) to:
RAKOCZY MOLINO MAZZOCHI SIWIK LLP
6 West Hubbard Street, Suite 500
Chicago, Illinois 60654
Attn:  William A. Rakoczy
Facsimile:  (312) 222-6321

11.3Assignment.

11.3.1Subject to Section 11.3.2, neither Party shall assign or transfer any of its rights or obligations under this Agreement without the prior written consent of the other Party, not to be unreasonably withheld or delayed. 

11.3.2Each Party shall be entitled, without prior written consent of the other Party, to assign all or any of its rights or obligations under this Agreement to an Affiliate or transfer such rights and obligations to a successor entity by way of merger or acquisition of substantially all of the assets of such Party (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.  [**].  The assignment of this Agreement by APP shall not in anyway affect APPs duties, obligations and admissions in the Settlement Agreement or the other Settlement Documents, and APP will continue to be bound by the terms of the Consent Judgment. 

11.3.3Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Any assignment or transfer in contravention of the terms of this Agreement shall be null and void.

11.4Amendment.  This Agreement may not be varied, changed, waived, discharged or terminated, including by course of conduct or trade usage, except by an instrument in writing signed by the Party against which enforcement of such variation, change, waiver, discharge or termination is sought.

11.5Public Announcements.  The terms of the Settlement Documents and the negotiations of the Parties pertaining to them, shall be maintained in confidence by the Parties.  Without limiting the generality of the foregoing, neither Party or its counsel shall provide discovery (including documents, oral testimony and/or statements whether by deposition or otherwise, the work of outside experts or consultants, or work product embodying any of the above) to any Third Party in any judicial or arbitral proceeding in the Territory pertaining to the Settlement Documents.  Notwithstanding these obligations, (i) a Party may issue a press release with the prior written consent of the other Party (such consent to be at the sole discretion of such other Party); (ii)  MDCO may issue a press release in the form attached hereto as Schedule 11.5, and APP may issue a press release in the form attached hereto as Schedule 11.6; (iii) either Party may disclose such terms or discovery as otherwise required by court order, provided that the other Party shall be given the opportunity to (a) review and comment on the proposed disclosure reasonably in advance of the disclosure, and (b) quash such order and to obtain a protective order requiring that the information and documents that are the subject of such order be held in confidence by such court; (iv) MDCO may disclose (a) to a Third Party (a “Settling Party”), who is identified in writing to APP in advance of any disclosure, the terms set forth in Sections 2 and 4 (along with the defined terms in Section 1 referenced in those provisions) that trigger a most favored nations provision in a settlement relating to the Litigated Patents, the '404 Patent or Angiomax between MDCO and such Settling Party, provided that such disclosure is solely for purposes of establishing whether and to what extent such a most favored nations provision has been triggered and such Settling Party has agreed in writing to maintain the confidentiality of such terms of the Settlement Documents and not to use such terms other than in connection with such purpose and no other purpose, and (b) to a person unaffiliated with such Settling Party and acceptable to MDCO Sections 2 and 4 (along with the defined terms in Section 1 referenced in those provisions) solely to assess the applicability of the most favored nations provision to the terms disclosed to such Settling Party, provided that such unaffiliated person has agreed in writing to maintain the confidentiality of the Settlement Documents and not to use such terms other than in connection with such assessment and no other purpose; (v) either Party may disclose such terms to such Party's actual and prospective investors and lenders, attorneys, accountants, insurers and FDA consultants on a need-to-know basis and who have agreed in writing and in advance to maintain the confidentiality of such information in accordance with the confidentiality provisions set forth herein; (vi) APP may disclose such terms to the FDA as may be necessary or useful in obtaining and maintaining Regulatory Approval of the APP ANDA and Launching the APP Product as provided by the License Agreement, so long as APP requests that the FDA maintain such terms in confidence, and (vii) APP may disclose such terms to its manufacturers, suppliers, distributors, marketing partners and customers in accordance with APP's exercise of its pre-Launch rights set forth in Sections 2.1 and 3.1 and (viii) either Party may disclose such terms as otherwise required by Law, including SEC reporting requirements, or by the rules or regulations of any stock exchange to which the Parties are subject; provided that, the Parties will coordinate in advance with each other in connection with the redaction of certain provisions of the Settlement Documents with respect to any SEC filings, and each Party shall use reasonable efforts to seek confidential treatment for such terms; provided, however, that 

each Party shall ultimately retain control over what information to disclose to the SEC or any other such agencies.  
 
11.6Superiority of Agreement.  The Parties agree that this Agreement supersedes all prior discussions and writings of the Parties, and that the provisions of this Agreement, together with any amendments hereto, shall prevail over any inconsistent statements or provisions contained in any prior discussions, arrangements or comments between the Parties and in any documents passing between the Parties, including, any forecast, purchase order, purchase order revision, acknowledgment, confirmation or notice.  It is agreed that:

11.6.1neither Party has entered into this Agreement in reliance upon any representation, warranty or undertaking of the other Party which is not expressly set out in this Agreement;

11.6.2neither Party shall have any remedy in respect of misrepresentation or untrue statement made by the other Party or for any breach of warranty which is not contained in this Agreement; 

11.6.3this Section 11.6 shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation; and

11.6.4notwithstanding the foregoing, the Settlement Agreement shall be deemed of equal dignity to this Agreement and this Agreement shall be construed together with the Settlement Agreement in a consistent manner as reflecting a single intent and purpose.

11.7Governing Law.  This Agreement shall be governed by the Laws of the State of Delaware without regard to the conflicts of law provisions thereof.  The Parties irrevocably agree that the United States District Court for the District of Delaware shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with this Agreement and that, accordingly, any proceedings arising out of or in connection with this Agreement shall be brought in the United States District Court for the District of Delaware.  Notwithstanding the foregoing, if there is any dispute for which the United States District Court for the District of Delaware does not have subject matter jurisdiction, the state courts in Wilmington, Delaware shall have jurisdiction.  In connection with any dispute arising out of or in connection with this Agreement, each Party hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of Delaware. 
 
11.8Agreement Costs.  Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion of this Agreement.

11.9Counterparts.  This Agreement may be executed in any number of counterparts and may be executed by the Parties on separate counterparts (including fax or electronic counterparts), each of which is an original but all of which together constitute the same instrument.

11.10Severability.  If and to the extent that any provision of this Agreement is held to be illegal, void or unenforceable, such provision shall be given no effect and shall be deemed not to be included in this Agreement but without invalidating any of the remaining provisions of this Agreement.

11.11Relationship of the Parties. In making and performing this Agreement, the Parties are acting, and intend to be treated, as independent entities; and nothing contained in this Agreement shall be construed or implied to create an agency, partnership, joint venture, or employer and employee relationship between MDCO and APP.  Except as otherwise provided herein, neither Party may make any representation, warranty or commitment, whether express or implied, on behalf of or incur any charges or expenses for or in the name of the other Party.     

11.12Construction.  The language in all parts of this Agreement shall be construed, in all cases, according to its fair meaning.  MDCO and APP acknowledge that each Party and its counsel have reviewed and revised this Agreement and that any rule of construction to the effect that any ambiguities are to be resolved against 

the drafting Party shall not be employed in the interpretation of this Agreement.  The words “hereof,” “herein,” “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.  The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.   Whenever used herein, the words “include,” “includes” and “including” shall mean “include, without limitation,” “includes, without limitation” and “including, without limitation,” respectively.  The masculine, feminine or neuter gender and the singular or plural number shall each be deemed to include the others whenever the context so indicates. With respect to any particular action or agreement, the use of the words “MDCO shall” or “MDCO will” herein shall also mean “MDCO shall cause” the particular action to be performed.  Similarly, with respect to any particular action or agreement, the use of the words “APP shall” or “APP will” herein shall also mean “APP shall cause” the particular action to be performed.  Nothing in this Agreement shall operate to exclude any provision implied into this Agreement by Law and which may not be excluded by Law or limit or exclude any liability, right or remedy to a greater extent than is permissible under Law. 

11.13Dispute Resolution.

11.13.1Preliminary Process.  If there is a disagreement between the Parties as to the interpretation of this Agreement or in relation to any aspect of the performance by either Party of its obligations under this Agreement, the Parties shall, within ten (10) Business Days of receipt of a written request from either Party, meet in good faith and try to resolve the disagreement without recourse to legal proceedings.

11.13.2Escalation of Dispute.  If resolution of the disagreement does not occur within five (5) Business Days after such meeting, the matter shall be escalated to applicable APP and MDCO Presidents (or other ranking senior executive) for resolution.  

11.13.3Equitable Relief.  Nothing in this Section 11.13 restricts either Party's freedom to seek urgent relief to preserve a legal right or remedy, or to protect a proprietary or trade secret right, or to otherwise seek legal remedies through any available channel if resolution is not otherwise achieved under this Section 11.13.

11.14Cumulative Rights.  The rights and remedies of each of the Parties under or pursuant to this Agreement are cumulative, may be exercised as often as such Party considers appropriate and are in addition to its rights and remedies under general law.

11.15No Third Party Benefit.  This Agreement shall be binding upon and inure solely to the benefit of the Parties hereto, their Affiliates, successors and permitted assigns, and nothing in this Agreement, express or implied, is intended to or shall confer upon any other Person or Persons any right, benefits or remedies of any nature whatsoever under or by reason of this Agreement.

11.16Further Assurance.  Each of the Parties shall do, execute and perform and shall procure to be done and perform all such further acts, deeds, documents and things as the other Party may reasonably require from time to time to give full effect to the terms of this Agreement.

11.17Waiver.  No failure or delay by either Party in exercising any right or remedy provided by law under or pursuant to this Agreement shall impair such right or remedy or operate or be construed as a waiver, acquiescence or variation of it or preclude its exercise at any subsequent time and no single or partial exercise of any such right or remedy shall preclude any other or further exercise of it or the exercise of any other right or remedy. A waiver by a Party of any right or remedy hereunder on any one occasion shall not be construed as a bar to any right or remedy which such Party would otherwise have on any future occasion.  

[Signature Page Follows]

[Signature Page to License Agreement Regarding Bivalirudin Injection Product]
IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the Effective Date.

THE MEDICINES COMPANY

Date: _______________        By: __/s/ Glenn Sblendorio_______________

Name: ____ Glenn Sblendorio ____________
                    
Title: _____EVP & CFO__________________

APP PHARMACEUTICALS, LLC

Date: ____1/22/12________        By: ____/s/ J.R. Ducker___________________

Name: _____J.R. Ducker___________________
                    
Title: ______President & CEO______________

Date: ____1/22/12________        By: ____/s/ J.R. Ducker___________________

Name: _____J.R. Ducker___________________
                    
Title: ______President & CEO______________

Schedule 11.5

Contact: Michael Mitchell
The Medicines Company
973-290-6000
investor.relations@themedco.com

FINAL DRAFT 1 22 2012
THE MEDICINES COMPANY SETTLES ANGIOMAX® (BIVALIRUDIN) PATENT LITIGATIONS WITH APP PHARMACEUTICALS

Parsippany, N.J., January 23, 2012- The Medicines Company (NASDAQ: MDCO) today announced that it has settled the lawsuits filed by MDCO in the U.S. District Court for the District of Delaware relating to the Abbreviated New Drug Application (ANDA) filed by APP Pharmaceuticals, LLC (APP) for a generic version of Angiomax® (bivalirudin for injection).  The settlement also includes APP's agreement to dismiss its appeal of the August 2010 federal district court decision holding that MDCO's application for Hatch Waxman patent term extension of the Angiomax composition of matter patent, U.S. Patent No. 5,196,404, was timely filed.  Upon dismissal of the appeal, all pending litigation regarding the Angiomax composition of matter patent will have been resolved.
As part of the settlement, APP admits that the two patents asserted in the lawsuits related to APP's ANDA, U.S. Patent No. 7,582,727 and U.S. Patent No. 7,598,343, are valid and enforceable against, and would be infringed by, APP's proposed generic bivalirudin product.  These patents are listed in the Orange Book and expire on July 27, 2028. 
MDCO and APP also agreed to the following arrangements in connection with the settlement:
License by MDCO
The settlement agreement includes a license by MDCO to APP and an affiliate of APP under which APP may launch a generic bivalirudin product in the U.S. on May 1, 2019.  In certain limited circumstances, this license to APP could become effective prior to May 1, 2019 and could include an authorized generic bivalirudin product supplied by MDCO.  
Finished Product Manufacturing for MDCO
MDCO entered into an agreement with APP under which APP has agreed to manufacture and supply Angiomax finished product to MDCO.  This manufacturing arrangement provides MDCO with an additional source of finished product supply capacity to support anticipated growth of product use, and replaces capacity recently lost when one of MDCO's fill and finish manufacturers announced that it would cease contract manufacturing operations. 

Acute Care Generic Products Portfolio Licensed by MDCO 
MDCO and APP entered into an agreement under which APP has agreed to license and supply to MDCO a portfolio of generic products which are used in therapeutic areas in which MDCO focuses or plans to focus, including treatment of acute cardiovascular, neurological and infectious diseases in hospital. 

Glenn Sblendorio, Executive Vice President and Chief Financial Officer of The Medicines Company stated, “These arrangements reflect our continued confidence in the strength of our Angiomax patents.  We are delighted to partner with APP for additional Angiomax fill and finish manufacturing capacity.  Also, we believe that the portfolio of acute and intensive care hospital generic products that we have licensed aligns well with our portfolio of marketed and development-stage innovative products and that our customers will welcome the expansion of our product offerings.”

As required by law, MDCO and APP will submit all of the agreements entered into in connection with the settlement to the U.S. Federal Trade Commission and the U.S. Department of Justice.

For a more detailed summary of the terms and financial  arrangements between MDCO and APP, please refer to the Current Report on Form 8-K filed by MDCO with the Securities and Exchange Commission on January 23, 2012.

Background on the litigation now settled.
In September 2009 and April 2010, MDCO received Paragraph IV Certification Notice Letters from APP notifying MDCO that APP had submitted an ANDA to the Food and Drug Administration for approval to market a generic version of Angiomax®.  In October 2009 and June 2010, MDCO filed patent infringement lawsuits against APP.  The complaints, which were filed in the U.S. District Court for the District of Delaware, alleged infringement of U.S. Patent Nos. 7,582, 727 and 7,598,343.  

MDCO remains in infringement litigations involving U.S. Patent Nos. 7,582, 727 and 7,598,343 with Hospira, Mylan Pharmaceuticals, Dr. Reddy's Laboratories and Sun Pharmaceuticals.

In the first quarter of 2010, MDCO filed suit against the U.S. Patent and Trademark Office (PTO), the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) seeking to set aside the PTO's denial of MDCO's application to extend the patent term of the '404 patent.  On August 3, 2010, the U.S. Federal District Court for the Eastern District of Virginia ordered the PTO to consider MDCO's patent term extension application timely filed. The period for the government to appeal the court's August 3, 2010 decision expired without government appeal. However, on August 19, 2010, APP filed a motion to intervene for the purpose of appeal in MDCO's case against the PTO, the FDA and HHS.  On September 13, 2010, the federal district court denied APP's motion. APP appealed the denial of its motion, as well as the federal district court's August 3, 2010 order (and all related and underlying orders), to the U.S. Court of Appeals for the Federal Circuit.

About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. 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 the extent of the commercial success of Angiomax, the Company's other products and the products licensed from APP; whether the Company is able to maintain market exclusivity for Angiomax; whether the Company is able to obtain or maintain patent protection for the intellectual property relating to the Company's products; whether the Company's products and product candidates will advance in the clinical trials process on a timely basis or at all; whether the Company will make regulatory submissions for product candidates on a timely basis; whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all ; risks related to the Company's dependence on third parties such as APP to manufacture and supply its 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, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.MDCO EX 10.3 03.31.2012

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

	Exhibit 10.3

Confidential 

EXECUTION COPY

Contract Manufacturing Agreement
January 22, 2012

CONTRACT MANUFACTURING AGREEMENT
THIS MANUFACTURING SERVICES AGREEMENT (the "Agreement") made as of the 22nd day of January, 2012 (“Effective Date”)
B E T W E E N:
APP PHARMACEUTICALS, LLC,

1501 East Woodfield Road, Suite 300 East, Schaumburg, Illinois 6017, a corporation existing under the laws of the State of Delaware,
(hereinafter referred to as "APP"),
- and -
THE MEDICINES COMPANY
8 Sylvan Way, Parsippany, NJ 07054 a corporation existing under the laws of the State of Delaware (hereinafter referred to as "MDCO" and collectively with APP referred to herein as the “Parties,” or each separately, as a “Party.”).

RECITALS:

WHEREAS, MDCO wishes to have the Product manufactured, packaged, tested, and supplied to it by APP for commercial sales, and APP wishes to manufacture, package, test and supply to MDCO the Product for commercial sales, in accordance with the terms and conditions of this Agreement; and
WHEREAS, the Parties have agreed to enter into this Agreement to provide the terms and conditions governing the manufacture, packaging, testing and supply of the Product by APP. 
NOW, THEREFORE, MDCO and APP agree as follows:

ARTICLE 1

INTERPRETATION
		
	1.1
	Definitions.

The following terms shall, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings:
"Active Materials", “Active Pharmaceutical Ingredients” or “API” means the materials listed on Schedule C hereto;
"Affiliate" 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 meanings;
"Annual Report" means the annual report as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2);
"Annual Product Review Report" means the annual product review report as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e);

"Applicable Laws" means any statute, law, treaty, rule, code, ordinance, regulation, rule, by-law, judgment, decree or order that applies, as the context requires, to: (i) the Agreement; (ii) the performance of obligations or other activities related to the Agreement; and (iii) a party's Subcontractors (if any).
"Authority" means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal;
“Batch Size” means the estimated batch size of the Product (measured in number of units of such Product) as set forth in Schedule A;
"Business Day" means any day other than a Saturday, Sunday or a day on which banks in New York, New York are authorized or required by law to close;
"cGMPs" means the current good manufacturing practices required by the FDA and set forth in the United States Food, Drug and Cosmetic 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;
“Capital Expenditures” means all out-of-pocket costs and expenses relating to upgrading or acquiring equipment at the Manufacturing Site directly related to, and necessary for, APP's provision of the Manufacturing Services, as set forth on Schedule E;
“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.
"Components" means, collectively, primary packaging components, raw materials and ingredients, required to be used in order to produce the Product in accordance with the Specifications, other than the Active Materials;
“Confidential Information” means all 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;
"Deficiency Notice" shall have the meaning ascribed thereto in Section 6.1(a);
"Delivery Date" means the date of delivery of the Product at the Manufacturing Site, as stated in the acceptance of the Firm Order by APP;
“Development Costs and Expenses” means all out-of-pocket costs and expenses relating to research and 

development for the manufacture of the Product for sale in the Territory, including costs and expenses related to analytical testing (e.g., outside laboratory expenses), process development costs including costs of process scale-up, validation costs, costs of stability studies, and processing and conversion costs of materials required for regulatory filings, as set forth on Schedule D.
“Disclosing Party” means the Party disclosing Confidential Information;
“Effective Date” means the date set forth in the introductory paragraph that is the commencement date of this Agreement after execution by both Parties;
"FDA" means the United States government agency known as the Food and Drug Administration (and any successor agency thereto);
“Firm Order” means a firm written order in the form of a purchase order or otherwise that has been received by APP;
“Initial Supply Term” means the period starting on the first date that all Regulatory Authorities approve MDCO to market Product in the Territory that is manufactured by APP at the Manufacture Site and ending on June 15, 2015; 
"Intellectual Property" means any and all of the following, whether or not registered, in the United States and all other jurisdictions throughout the world: (i) Inventions and improvements thereto, 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; 
"Invention" means any innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable or copyrightable;
"Inventory" means all inventories of Components and work-in-process produced or held by APP in connection with the manufacture of the Product but, for greater certainty, does not include the Active Materials;
"Know-How" means confidential and proprietary information related to the Product, including: manufacturing protocols and methods, the Product formulation, Product specifications, processes, analytical and processing techniques, Product and API samples, trade secrets, ideas, concepts, manufacturing formulae and information, and flow diagrams. 
"Manufacturing Requirements" shall have the meaning ascribed thereto in Section 2.4;
"Manufacturing Services" means the manufacturing, packaging, quality control, quality assurance and stability testing, and related services, as contemplated in this Agreement, required to produce the Product from Active Materials and Components;
"Manufacturing Services Based Intellectual Property"  means Intellectual Property generated or derived by APP or its Affiliate in the course of performing any Manufacturing Services or otherwise generated or derived by APP or its Affiliate in connection with the conduct of its business which Intellectual Property is not specific to, or dependent upon, MDCO's Active Material or Product including, without limitation, Inventions and Intellectual Property which may have application to manufacturing processes or the formulation or 

development of drug products, drug product dosage forms or drug delivery systems beyond the specific requirements of the Product.
"Manufacturing Site" means the APP's facility, which is located at [**];
“Marketing Authorization” means any federal, state, or local approvals, licenses, permits, applications, registrations or authorizations approved by, filed with, or submitted to any Authority, such as the FDA, including all Abbreviated New Applications and New Drug Applications;
"Minimum Run Quantity" means the minimum number of batches of the Product to be produced during the same cycle of manufacturing as set forth in Schedule A hereto;
“Party(ies)” means either APP or MDCO, or both, as the case may be;
"Price" means $[**] U.S. Dollars per vial, as adjusted pursuant to Article 4;
"Product" means 10 ml vials containing 250 mg of lyophilized bivalirudin for injection, currently marketed as Angiomax®; 
"Quality Agreement" means the agreement to be entered into between the Parties hereto setting out the respective responsibilities of the Parties and the quality assurance standards in respect of the Manufacturing Services; 
“Receiving Party” means the Party to whom Confidential Information is disclosed;
"Regulatory Authority" means any regulatory agency competent to grant marketing approvals for pharmaceutical products including the Product in the Territory, such as the FDA;
"Specifications" means the file and specifications for the Product, which is provided by MDCO to APP in accordance with the procedures listed in the Quality Agreement hereto and which contains documents relating to the Product, including, without limitation:
		
	a)
	specifications for Active Materials and Components;

		
	b)
	manufacturing specifications, directions and processes;

		
	c)
	storage requirements; 

		
	d)
	all environmental, health and safety information relating to the Product including material safety data sheets; and

		
	e)
	the finished Product specifications, packaging specifications and shipping requirements for the Product. 

all as updated, amended and revised from time to time by MDCO in accordance with the terms of this Agreement;
“Subsequent Supply Term” means the period starting on June 15, 2015 and ending on May 1, 2019;
"Technical Dispute" has the meaning specified in Section 12.2;
“Technology Transfer and Feasibility Activities” shall have the meaning specified in  Section 2.1.
"Territory" means the United States of America and its possessions and territories;
"Third-Party Rights" means the Intellectual Property of any third party;
"Year" means, in the first year of this Agreement, the period from the Effective Date up to and including December 31 of the same calendar year, and thereafter shall mean a calendar year.

		
	1.2
	Currency.  

Unless otherwise indicated, all monetary amounts are expressed in this Agreement in U.S. Dollars.  References to $ will be references to U.S. Dollars.
		
	1.3
	Sections and Headings.  

The division of this Agreement into Articles, sections, subsections and Schedules and the insertion of headings are for convenience of reference only and shall not affect the interpretation of this Agreement.  Unless otherwise indicated, any reference in this Agreement to a Section or Schedule refers to the specified Section or Schedule to this Agreement.  In this Agreement, the terms "this Agreement", "hereof", "herein", "hereunder" and similar expressions refer to this Agreement and not to any particular part, Section, Schedule or the provision hereof.
		
	1.4
	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.  
		
	1.5
	Schedules. 

The following Schedules are attached to, incorporated in and form part of this Agreement: 
Schedule A    -    Minimum Run Quantity, and Price
Schedule B    -    Stability Testing Activities 
Schedule C    -    Active Materials 
Schedule D    -    Development Costs and Expenses
Schedule E        Capital Expenditures

		
	ARTICLE 2
	

APP'S MANUFACTURING SERVICES
2.1Technology Transfer Activities. 
    
Within [**] days of the Effective Date, and on an ongoing basis thereafter, MDCO will supply APP with the materials and documentation that are in MDCO's possession free of an obligation of confidentiality to a third party, which will include Know-How and any other knowledge, documentation and information that may be necessary or useful for APP to commercially manufacture the Product.  The manufacture of the Product will be transferred to the Manufacturing Site according to a time schedule to be agreed upon between the Parties.  In addition, APP agrees to initiate as soon as reasonably possible the technical transfer and feasibility activities necessary for the transfer of the commercial manufacture of the Product to the Manufacturing Site.  
		
	2.2
	Supply.

For the Initial Supply Term, MDCO shall order at least [**] percent ([**]%) of its requirements for sale of Product in the Territory from APP and APP shall use Commercially Reasonable Efforts to supply MDCO all such amounts ordered (pro-rata for any non-full Year during the Initial Supply Term).  For the Subsequent Supply Term, MDCO shall order at least [**] percent ([**]%) of MDCO's requirements for sale of Product in the Territory and APP shall use Commercially Reasonable Efforts to supply MDCO all such amounts ordered (pro-rata for any non-full Year during the Subsequent Supply Term); [**].  In addition, APP shall supply Product to MDCO for resale to APP, under the terms of an AG Supply Agreement being entered into by the Parties contemporaneously herewith (the “AG Supply Agreement”).

2.3Manufacturing Services.

APP shall provide the Manufacturing Services for the Territory, as specified in Schedules A and B.  APP and MDCO agree that for all Product supplied to MDCO pursuant to this Agreement:
		
	a)
	Conversion of Active Materials and Components.  APP shall convert Active Materials and Components into the Product.

		
	b)
	Quality Control and Quality Assurance.  APP shall perform the quality control and quality assurance testing specified in the Quality Agreement.  

		
	c)
	Components.  APP shall purchase and test all Components as specified by the Specifications and per the Quality Agreement.

  
		
	d)
	Stability Testing.  APP shall conduct stability testing on the Product in accordance with the protocols set out in the Specifications and during the time periods specified in Schedule B.  

		
	e)
	Product Rejection for Finished Product Specification Failure. If the non-conforming Product results from APP's failure to perform the Manufacturing Services in accordance with the Manufacturing Requirements, then MDCO shall not be required to pay APP the applicable fee per unit for such non-conforming Product. 

		
	f)
	Batch Numbering. Each batch of the Product manufactured by APP will bear a unique lot number using APP's batch numbering system.  This number will appear on all documents relating to the particular batch of Product and shall identify the date of manufacture for the batch of Product.

		
	g)
	Active Materials and MDCO Supplied Components Importing.  At least [**] days prior to the scheduled production date, MDCO shall furnish to APP, EXW (Incoterms 2010) at Manufacturing Site, the Active Materials in such quantities as are necessary to enable APP to manufacture the desired quantities of Product on the requested delivery date. If such Active Materials are not received [**] days in advance, APP will be entitled to delay shipments of Product caused by the re-scheduling of production by the same number of days as the delay in receipt of such Active Materials.  All shipment of Active Material shall be accompanied by certificate(s) of analysis from the Active Material manufacturer confirming the identity, purity and compliance with the Active Material Specifications.

		
	2.4
	Standard of Performance.

APP shall provide the Manufacturing Services in accordance with (i) the Specifications; (ii) any other terms and conditions provided in the Quality Agreement; (iii) the cGMPs and any other applicable legal requirements as specified by any Regulatory Authority.  APP's responsibilities and obligations with respect to the manufacture of the Product as set forth in this Section 2.4 are herein referred to as the "Manufacturing Requirements". 
		
	2.5
	Subcontractors.  

MDCO hereby agrees that APP may subcontract to an Affiliate any Manufacturing Services under this Agreement provided that APP identifies in writing the Affiliate and the Manufacturing Services to be provided and MDCO consents in writing, such consent not to be unreasonably withheld by MDCO (such a subcontractor, herein a “Subcontractor.”) It is understood that APP shall enter into an agreement with its Affiliate that contains confidentiality and non-use terms similar to and at least as strict as those set forth in Article 11 of this Agreement, as well as any other terms necessary to ensure that APP meets its obligations under this Agreement. For the avoidance of doubt, the subcontracting of any Services hereunder by APP shall not relieve APP of, and APP shall remain solely liable for, its obligations under this Agreement.
2.6Supply Interruption.

		
	a) 
	In the event that (i) APP is past due in its obligations to supply Product to MDCO in accordance with APP's obligations under this Agreement for [**] days or more; or (ii) APP fails to confirm any forecast or Firm Order because of its inability to timely supply at least [**] percent ([**]%) of the amount forecasted 

therein, including as may be attributed to a Force Majeure Event pursuant to Section 13.7 but excluding as may be attributed to the failure of MDCO to comply with its obligations under this Agreement (including but not limited to the failure to supply Active Materials) (individually or collectively a "Supply Interruption"), it is agreed by the Parties that MDCO, in its discretion, may cancel any and all Firm Orders for Product outstanding at the commencement of a Supply Interruption by providing written notice to APP, and MDCO may also, in its discretion, suspend providing further forecasts and Firm Orders to APP until a Recommencement Date (defined below).  Following a Supply Interruption and until a Recommencement Date, it is agreed by the Parties that MDCO, in its discretion, may be supplied by a secondary supplier with Product to meet MDCO's full requirements of Product. All amounts of Product supplied by a secondary supplier to MDCO during a Supply Interruption (including all amounts forecasted or ordered before a Recommencement Date, regardless if whether delivered after a Recommencement Date) shall be credited toward MDCO's obligation under Section 2.2 to purchase a percentage amount, as applicable, of its requirements from APP and shall be treated as if such amounts of Product had been supplied from APP. 
		
	b) 
	APP shall provide MDCO with written notice of its ability to resume supply (the "Recommencement Notice"), if APP is able to resume timely supply of Product.  The Recommencement Notice must:  (i) list the date on which APP will be able to resume its supply obligations; and (ii) include a statement of APP's ability to resume such obligations by that date which describes in reasonable detail what problems have been rectified and include a representation (which will be deemed a APP representation under this Agreement) that APP is able to fulfill its supply obligations under this Agreement.  Unless otherwise agreed to in writing by MDCO and APP, MDCO shall resume purchasing its requirements for the Product from APP, as set forth in Section 2.2, commencing on the later of (i) [**] days from MDCO's receipt of the Recommencement Notice, and (ii) [**] (the "Recommencement Date").

		
	c) 
	In the event that (i) a Supply Interruption exists for more than [**], (ii) [**] or more Supply Interruptions occur within any [**] month period, or (iii) [**] or more Supply Interruptions occur in any [**] period during the term of the Agreement, it is agreed by the Parties that MDCO's obligation under Section 2.2 to purchase a percentage amount, as applicable, of its requirements from APP shall immediately and permanently terminate.

		
	ARTICLE 3
	

MDCO'S OBLIGATIONS
3.1Payment.

Pursuant to the terms of this Agreement, MDCO shall pay APP the Price for each Product during the term of this Agreement.  For the purpose of clarity, the Price includes all payment to APP for the Manufacturing Services. 
3.2Development Costs and Expenses.

MDCO shall reimburse APP for the Development Costs and Expenses actually spent or incurred by APP during the term of this Agreement  that are listed on Schedule D; provided that MDCO shall not pay APP more than [**] U.S. Dollars ($[**]) pursuant to this Section 3.2.  MDCO will not reimburse APP for expenses incurred by APP before the Effective Date.  APP shall invoice MDCO for Development Costs and Expenses within [**] days of being spent or incurred by APP and MDCO shall pay all such invoices within [**] days of the date thereof.
3.3Capital Expenditure Reimbursement.

MDCO shall reimburse APP for the Capital Expenditures actually spent or incurred by APP during the term of this Agreement that are listed on Schedule E; provided that MDCO shall not pay APP more than [**] U.S. Dollars ($[**]) pursuant to this Section 3.3. MDCO will not reimburse APP for expenses incurred by APP before the Effective Date.  APP shall invoice MDCO for Capital Expenditures within [**] days of being spent or incurred by APP and MDCO shall pay all such invoices within [**] days of the date thereof.
3.4Active Materials.

MDCO shall at its sole cost and expense, deliver the Active Materials to APP (in accordance with Section 2.2(g)) in sufficient quantities and at such times to facilitate the provision of the Manufacturing Services by APP. The Active Materials shall be held by APP on behalf of MDCO in accordance with the Specifications, with any other label and invoice instructions given by MDCO from time to time in accordance with this Agreement and with the current GMPs. Title to the Active Materials shall at all times belong to and remain the property of MDCO.  Any Active Materials received by APP shall only be used by APP to provide the Manufacturing Services.  
		
	ARTICLE 4
	

PRICING
4.1Initial Adjustments.

During the Initial Supply Period, APP shall be entitled to an adjustment equal to [**] percent ([**]%) of the Price no more than once per Year.  
4.2Subsequent Adjustments. 

The Price for the Product during any Year subsequent to [**], shall be determined in accordance with the following:  APP shall be entitled to an adjustment to the Price in respect of the Product to reflect inflation, which adjustment shall be based on the annual change in the Producer Price Index applicable to pharmaceutical preparations published by the U.S. Bureau of Labor Statistics, Department of Labor (or any applicable successor index to be agreed to by the Parties in good faith in the event of the discontinuation of same) over the prior twelve (12) month period, provided that such adjustment is not greater than [**] percent ([**]%). In connection with such Price adjustment, three (3) months prior to the effective date of the adjusted Price, APP shall deliver to MDCO a statement outlining the percentage change in the Producer Price Index upon which such price adjustment is based. The adjusted prices shall be effective as of January 1 of the same Year in which the adjustment is required and shall be applied to all Firm Orders on or after January 1. 

		
	ARTICLE 5
	

ORDERS, SHIPMENT, INVOICING, PAYMENT
		
	5.1
	Orders and Forecasts.  

		
	a)
	Rolling Forecasts.  Following the execution of this Agreement, MDCO shall provide APP with a written non-binding [**] month forecast of the volume of Product that MDCO then anticipates will be required to be produced and delivered to MDCO, beginning with the Initial Supply Term during each month of that [**] month period. At the commencement of the Initial Supply Term, such forecast will be updated by MDCO monthly on or before the [**] day of each calendar month on a rolling [**] month basis and updated forthwith upon MDCO determining that the volumes contemplated in the most recent of such forecasts has changed by more than [**] percent ([**]%). The most recent [**] month forecast shall prevail.  Within [**] days or receipt of a forecast, APP shall confirm its ability to timely supply MDCO with the Product specified in such forecast.

		
	b)
	Firm Orders.  The first [**] months of the initial rolling forecast shall constitute a Firm Order upon receipt by APP.  Thereafter, on or before the [**] day of each calendar month, MDCO shall issue Firm Orders for Manufacturing Services in respect of the Product to be produced and delivered to MDCO on a date not less than [**] months from the first day of the calendar month immediately following the date that the Firm Order is submitted.  Such Firm Orders submitted to APP shall specify MDCO's Manufacturing Services purchase order number, quantities by Product type, monthly delivery schedule and any other elements necessary to ensure the timely production and shipment of the Product. The quantities of Product ordered in such written orders shall be firm and binding on MDCO and shall not be subject to reduction by MDCO. Within [**] days of receipt of a Firm Order, APP shall confirm its ability to timely supply MDCO with the Product specified in Firm Order. 

		
	c)
	APP will deliver the ordered batch(es) of Product by the Delivery Date and shall promptly alert MDCO, in writing, of any delay that may affect such Delivery Date. Should a delay in delivery occur, APP will develop and carry out a remedial plan with MDCO to help prevent further possible late deliveries.

		
	d)
	APP and MDCO will develop, establish and review appropriate key performance indicators (KPI's) during the term of this Agreement to assess and improve the ongoing effectiveness of the Manufacturing Services. These KPI's will be reviewed on a quarterly basis. The KPI's should be agreed upon by both Parties, but should, at a minimum, include production yields for Product lots, on time delivery and batch record cycle review. 

		
	5.2
	Minimum Orders.

MDCO may only order Manufacturing Services in respect of batches of Product in multiples of the Minimum Run Quantities as set out in Schedule A.
		
	5.3
	Shipments.

Shipments of Product shall be made EXW (Incoterms 2010) MDCO's designated facility, unless otherwise mutually agreed. Product shall be transported in accordance with the Specifications. 
		
	5.4
	Invoices and Payment.

Invoices shall be sent by email to the accounts payable email address provided by MDCO.  Invoices will be sent, by APP to MDCO, at the time the Product is shipped to MDCO. Disputes regarding the amount of the invoices will not suspend MDCO's payment obligations. Each such invoice shall, to the extent applicable, identify MDCO's Manufacturing Services purchase order number, Product numbers, names and quantities, unit price, freight charges and the total amount to be remitted by MDCO. MDCO shall pay all such invoices within [**] days of the date thereof. 
		
	ARTICLE 6
	

PRODUCT CLAIMS AND RECALLS
		
	6.1
	Product Claims.

		
	a)
	Product Claims.  MDCO has the right to reject any portion of any shipment of Product that deviates from the Manufacturing Requirements without invalidating any remainder of such shipment.  MDCO shall inspect the Product manufactured by APP upon receipt thereof and shall give APP written notice (a "Deficiency Notice") of all claims for Product that deviate from the Manufacturing Requirements within [**] days after MDCO's receipt thereof (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, within [**] days after discovery thereof by MDCO, but in no event after the earlier of (i) expiration date of the Product or (ii) the statute of limitations applicable to contract actions as applied pursuant to Section 13.15). Should MDCO fail to provide APP with the Deficiency Notice within the applicable [**] day period, then the delivery shall be deemed to have been accepted by MDCO on the [**] day after delivery or discovery, as applicable.  Except as set out in Section 6.2, APP shall have no liability for any deviations for which it has not received notice within the applicable [**] day period.

		
	b)
	Determination of Deficiency.  Upon receipt of a Deficiency Notice, APP shall have [**] days to advise MDCO by notice in writing that it disagrees with the contents of such Deficiency Notice. If MDCO and APP fail to agree within [**] days after APP's notice to MDCO as to whether any Product identified in the Deficiency Notice deviate from the Manufacturing Requirements, then the Parties shall mutually select an independent laboratory to evaluate if the Product deviate from the Manufacturing Requirements.  Such evaluation shall be binding on the Parties, and if such evaluation certifies that any Product deviate from the Manufacturing Requirements, MDCO may reject those Product in the manner contemplated in this Section 6.1. In that event the evaluation costs will be borne by APP, otherwise MDCO will be responsible for the evaluation costs. If such evaluation does not so certify in respect of any such Product, then MDCO shall be deemed to have accepted delivery of such Product on the [**] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the [**] day after discovery thereof by MDCO, but in no event after the expiration date of the Product).

		
	c)
	Shortages and/or damaged Product. Claims for shortages in the amount of Product shipped by APP and/or damages to Product delivered by APP shall be dealt with as may be reasonably agreed to by 

the Parties, consistent with the circumstances pertaining to the Product shortage or damage.

		
	6.2
	APP's Responsibility for Defective and Recalled Product.

		
	a)
	Defective Product. In the event MDCO rejects Product in accordance with Section 6.1 and the deviation is determined to have arisen from APP's failure to provide the Manufacturing Services in accordance with the Manufacturing Requirements, APP will credit MDCO's account for APP's invoice price for such defective Product. If MDCO shall have previously paid for such defective Product, APP shall promptly, at MDCO's election, either: (i) refund the invoice price for such defective Product; (ii) offset such amount against other amounts due to APP hereunder; or (iii) replace such Product with conforming Product without MDCO being liable for payment therefor under Section 3.1, contingent upon the receipt from MDCO of all Active Materials required for the manufacture of such replacement Product. For greater certainty, APP's responsibility for any loss of Active Materials in connection with defective Product shall be captured under Section 10.1.

		
	b)
	Recalled Product. To the extent that a recall or return results from, or arises out of, a failure by APP to provide the Manufacturing Services in accordance with the Manufacturing Requirements, APP shall be responsible for the documented out-of-pocket expenses of such recall or return and shall use its Commercially Reasonable Efforts to replace the recalled or returned Product with new Product, contingent upon the receipt from MDCO of all Active Materials required for the manufacture of such replacement Product.  For greater certainty, APP's responsibility for any loss of Active Materials in connection with recalled or returned Product shall be captured under Section 10.1. In the event that APP is unable to replace the recalled or returned Product (except where such inability results from a failure to receive the required Active Materials), then, upon MDCO's request, APP shall reimburse MDCO for the price that MDCO paid to APP for Manufacturing Services in respect of the affected Product. In all other circumstances, recalls, returns or other corrective actions shall be made at MDCO's cost and expense.

APP shall have no obligation for any product claims under Sections 6.1 or 6.2 to the extent such product claim (i) is caused by deficiencies with respect to the Specifications, the safety, efficacy or marketability of the Product or any distribution thereof, (ii) results from a defect in a Component that is not reasonably discoverable by APP using the test methods set forth in the Specifications, (iii) results from a defect in the Active Materials supplied by MDCO that is not reasonably discoverable by APP using the test methods set forth in the Specifications, (iv) is caused by actions of third parties occurring after such Product is shipped by APP pursuant to Section 5.3, (v) is due to packaging or labeling defects or omissions for which APP has no responsibility, (vi) is due to any unascertainable reason despite APP's having met the Manufacturing Requirements, or (vii) is due to any other breach by MDCO of its obligations under this Agreement.  
		
	6.3
	Disposition of Defective or Recalled Product.

MDCO shall not dispose of any damaged, defective, returned or recalled Product in relation to which it intends to assert a claim against APP without APP's prior written authorization to do so. Alternatively, APP may instruct MDCO to return such Product to APP. APP shall bear the cost of disposition with respect to any damaged, defective, returned or recalled Product in relation to which it bears responsibility under Sections 6.1 or 6.2 hereof.  In all other circumstances, MDCO shall bear the cost of disposition, including all applicable fees for Manufacturing Services, with respect to any damaged, defective, returned or recalled Product.
6.4Healthcare Provider or Patient Questions and Complaints.

MDCO shall have the sole responsibility for responding to questions and complaints from its customers. Questions or complaints received by APP from MDCO's customers, healthcare providers or patients shall be promptly referred to MDCO.  APP shall co-operate as reasonably required to allow MDCO to determine the cause of and resolve any such questions and complaints.  Such assistance shall include follow-up investigations, including testing. In addition, APP shall provide MDCO with all mutually agreed upon information that will enable MDCO to respond properly to questions or complaints relating to the Product as provided in the Quality Agreement.  Unless it is determined that the cause of any such complaint resulted from a failure by APP to provide the Manufacturing Services in accordance with the Manufacturing Requirements, all costs incurred in respect of this Section 6.4 shall be borne by MDCO.  In the event that the cause of the complaint is attributable to a failure by APP to provide the Manufacturing Services in accordance with the Manufacturing Requirements, such Product shall be deemed to be 

defective product as set forth in Section 6.2(a); and, MDCO shall be entitled to compensation and reimbursement by APP for such defective product in accordance with the provisions of Sections 6.1, 6.2 and 10.2.

		
	ARTICLE 7
	

CO-OPERATION
		
	7.1
	Quarterly Review.

Each Party shall forthwith upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for liaison between the Parties. The relationship managers shall meet not less than quarterly to review the current status of the business relationship and manage any issues that have arisen.
		
	7.2
	Access & Audits.

APP will provide MDCO with reasonable access at mutually agreeable times and during regular business hours to the areas of the Manufacturing Site in which the Product is manufactured, stored, handled or shipped to permit MDCO to verify that the Manufacturing Services are being performed in accordance with the Manufacturing Requirements.  But, with the exception of “for-cause” audits, MDCO will be limited each Year to one cGMP-type audit, lasting no more than [**] days, and involving no more than [**] auditors. MDCO may request additional cGMP-type audits, additional audit days, or the participation of additional auditors, which will be subject to APP's consent, not to be unreasonably withheld, delayed or conditioned. The right of access provided in this Section 7.2 will not include a right to access or inspect APP's financial records.  
		
	7.3
	Reports.

APP will supply on an annual basis all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing and storage), that MDCO reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that MDCO is required to file with the FDA, or other applicable competent Regulatory Authority. 
		
	7.4
	Regulatory Authority Filings.

MDCO shall own, and is solely responsible for maintaining any Marketing Authorization necessary for the marketing of the Product in the Territory and any relevant costs shall be borne by MDCO. For the avoidance of doubt, 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 any changes to the Product and/or Product Specifications that are requested by MDCO or any Authority, or are necessary to comply with such requests.

		
	ARTICLE 8
	

TERM AND TERMINATION
		
	8.1
	Term.

This Agreement shall become effective as of the Effective Date and shall continue until the end of the Subsequent Supply Term (the "Initial Term"), unless terminated earlier by one of the Parties in accordance herewith. This Agreement shall continue after the Initial Term at MDCO's sole option and discretion for an additional term of two (2) years.  MDCO will provide APP notice within ninety (90) days of the end of the Subsequent Supply Term on whether the term of the Agreement will be extended for the additional two (2) year term.  Thereafter this Agreement shall automatically terminate unless either Party gives written notice to the other Party of its intention to renew this Agreement at least eighteen (18) months prior to the end of the then current term, which renewal will be subject to both Parties' agreement.  Notwithstanding anything herein to the contrary, except as to a termination of this Agreement under Sections 8.2(a) by MDCO for APP's breach, or Section 8.2(c), in the event this Agreement terminates during or before a period when MDCO is to supply authorized generic product to APP pursuant to the AG Supply Agreement, this Agreement shall remain in effect solely with respect to, and to allow for, the supply of 

such authorized generic product to APP pursuant to the AG Supply Agreement.
		
	8.2
	Termination for Cause.

		
	a)
	Either Party, at its sole option, may terminate this Agreement upon written notice in circumstances where the other Party has failed to remedy a material breach of any of its representations, warranties or other obligations under this Agreement within sixty (60) days following receipt of a written notice (the "Remediation Period") of said breach that expressly states that it is a notice under this Section 8.2(a) (a "Breach Notice"). If the material breach by its nature is not curable, the non-breaching Party shall have the right to terminate this Agreement with immediate effect by giving the breaching Party notice of any such non-curable breach, specifying such non-curable breach in reasonable detail and stating that it terminates this Agreement, such termination right to be exercised within a period of thirty (30) days following the date as of which the terminating Party receives knowledge of any such breach.

		
	b)
	Either Party at its sole option may immediately terminate this Agreement upon written notice, but without prior advance notice, to the other Party in the event that: (i) the other Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other Party; or (iii) this Agreement is assigned by such other Party for the benefit of creditors.

		
	c)
	MDCO may terminate this Agreement upon thirty (30) days' prior written notice in the event that any Authority takes any action, or raises any objection, that prevents MDCO from purchasing or selling such Product in the Territory.

		
	d)
	In the event that a generically labeled Product is marketed in the Territory by a third party or APP, MDCO may seek to adjust the Price and supply quantities of Product manufactured pursuant to this Agreement.  In the event the Parties can not reach mutually agreeable pricing and supply quantities, MDCO shall have the right to terminate this Agreement upon ninety (90) days' prior written notice to APP.

8.3Product Discontinuation.

MDCO shall provide at least [**] months advance notice if it intends to no longer order Manufacturing Services for the Product due to discontinuance in its marketing.  In the event MDCO subsequently decides to reintroduce and market the Product in the Territory, MDCO shall be obligated to offer APP the right of first refusal to provide the Manufacturing Services under the terms of this Agreement.
		
	8.4
	Obligations on Termination.

If this Agreement is completed, expires or is terminated in whole or in part for any reason, then (in addition to any other remedies APP may have in the event of default by MDCO):
		
	a)
	MDCO shall take delivery of and pay for all undelivered Product that are manufactured pursuant to a Firm Order, at the price in effect at the time the Firm Order was placed;

		
	b)
	MDCO shall purchase, at APP's cost (including all costs incurred by APP in connection with the purchase and handling of such Inventory), the Inventory applicable to the Product that cannot reasonably be used for other Product produced by APP, that was purchased, produced or maintained by APP in contemplation of filling Firm Orders or in accordance with Section 5.1 prior to notice of termination being given; 

		
	c)
	MDCO shall satisfy the purchase price payable pursuant to APP's orders with suppliers of Components, provided such orders were made by APP in reliance on Firm Orders; 

		
	d)
	APP shall return to MDCO all unused Active Materials, retains and samples (with shipping and related expenses, if any, to be borne by MDCO) and MDCO shall be obligated to maintain any stability protocols set out in the Specifications; and

		
	e)
	MDCO shall pay any amounts due under the provisions of this Section 8.4 within [**] days of the date 

of termination or expiry of this Agreement.

Any termination or expiration of this Agreement shall not affect any outstanding obligations or payments due hereunder prior to such termination or expiration, nor shall it prejudice any other remedies that the Parties may have under this Agreement.  For greater certainty, termination of this Agreement for any reason shall not affect the obligations and responsibilities of the Parties pursuant to Articles 1, 8, 9, 10, 11, 12, and 13 and Sections 6.2, 6.3, and 6.4, all of which survive any termination.

		
	ARTICLE 9
	

REPRESENTATIONS, WARRANTIES AND COVENANTS
		
	9.1
	Authority.

Each Party covenants, represents and warrants that it has the full right and authority to enter into this Agreement, and that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder.
		
	9.2
	Product Warranties.

APP covenants, represents and warrants that it shall perform the Manufacturing Services in accordance with the Manufacturing Requirements.
		
	9.3
	Debarred Persons.

APP covenants that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b), or any analogous law or regulation.  APP represents that it does not have at the execution date of this Agreement, and covenants that it will not hire, as an officer or an employee any person who has been convicted of health care fraud or a felony under the laws of the United States for conduct relating to the regulation of any drug product under the 21 U.S.C. § 301 et seq. If any of APP or APP's Affiliate directors, officers, employees, agents, representatives or advisors, who perform services under this Agreement is debarred or receives notice of an action or threat of action of debarment, APP shall immediately notify MDCO of same and shall take all the appropriate disciplinary actions against the individuals responsible for the activity which constitutes cause for debarment. MDCO shall be entitled to terminate this Agreement pursuant to Section 8.2(a) in the event of debarment of APP or its Affiliates. 
		
	9.4
	No Warranty.

APP MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. APP MAKES NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY WITH RESPECT TO THE PRODUCT.

		
	ARTICLE 10
	

REMEDIES AND INDEMNITIES
		
	10.1
	Active Materials.

In the event the Active Materials are damaged or lost due to the failure of APP to provide the Manufacturing Services in accordance with the Manufacturing Requirements, APP shall be responsible for any loss or damage to the Active Materials.   
		
	10.2
	APP.

APP and its Affiliates agree to defend, indemnify and hold MDCO, its officers, employees and agents harmless against any and all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties resulting from, or relating to any claim of personal injury or property damage, to the extent that such injury or damage is the result of: (i) a breach of this Agreement by APP, including, without limitation, any representation 

or warranty contained herein, or (ii) APP's gross negligence or wilful misconduct in performing the Manufacturing Services in accordance with the Manufacturing Requirements, except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are due to the gross negligence or wrongful act(s) of MDCO, its officers, employees or agents or Affiliates. 
In the event of a claim, MDCO shall: (a) promptly notify APP of any such claim; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with APP in the defence of such claim; (d) permit APP to control the defence and settlement of such claim, all at APP's cost and expense.
		
	10.3
	MDCO.

MDCO agrees to defend, indemnify and hold APP, its Affiliates, officers, employees and agents harmless against any and all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties resulting from, or relating to any claim of personal injury or property damage to the extent that such injury or damage is the result of: (i) a breach of this Agreement by MDCO, including, without limitation, any representation or warranty contained herein, or (ii) any personal injury (including death) or property damage caused by the Product, except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are (i) due to the gross negligence or wrongful act(s) of APP, its officers, employees or agents, or (ii) subject to APP's indemnification under Section 10.2 of this Agreement or Section 8.2 of the AG Supply Agreement. 
In the event of a claim, APP shall: (a) promptly notify MDCO of any such claims; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with MDCO in the defence of such claim; (d) permit MDCO to control the defence and settlement of such claim, all at MDCO's cost and expense.
		
	10.4
	Reasonable Allocation of Risk.

The provisions of this Agreement (including, without limitation, this Article 10) are reasonable and create a reasonable allocation of risk having regard to the relative profits the Parties respectively expect to derive from the Product, and that APP, in its fees for the provision of the Manufacturing Services, has not accepted a greater degree of the risks arising from the manufacture, distribution and use of the Product, based on the fact that MDCO has developed and holds the marketing approval for the Product and requires APP to manufacture the Product strictly in accordance with the Specifications, and that MDCO and not APP is in a position to inform and advise potential users of the Product as to the circumstances and manner of use of the Product.  
		
	ARTICLE 11
	

CONFIDENTIALITY
In consideration for and as a condition to the Parties furnishing to one another access to Confidential Information, the Parties agree as follows:
		
	11.1
	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.

		
	11.2
	The Receiving Party agrees that the disclosure of Confidential Information will be made to it in confidence and that:

		
	a)
	The Receiving Party agrees to keep Confidential Information as confidential and secret.

		
	b)
	The Receiving Party agrees to restrict access to the Confidential 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 11.  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 11.

		
	c)
	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.

		
	d)
	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.

		
	e)
	The Receiving Party agrees to use the Confidential Information only in connection with the purpose of this Agreement.

		
	f)
	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.

		
	g)
	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 11 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.

		
	h)
	The Receiving Party agrees that the obligations of the Receiving Party set forth in this Article 11 are necessary and reasonable in order to protect the Disclosing Party and its business.

		
	11.3
	Anything to the contrary herein notwithstanding, the confidentiality obligations set forth in this Article 11 shall survive the expiration or termination of this Agreement for a period of [**] years following such expiration or termination.

		
	11.4
	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 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 12
	

DISPUTE RESOLUTION
		
	12.1
	Commercial Disputes.

In the event of any dispute arising out of or in connection with this Agreement (other than a dispute determined in accordance with Section 6.1(b) or a Technical Dispute), the Parties shall first try to solve it amicably.  In this regard, either Party may send a notice of dispute to the other, and each Party shall appoint, within [**] Days from receipt of such notice of dispute, a single representative to handle the dispute. The representatives so designated shall confer as necessary in order to solve such dispute. If these representatives fail to solve the matter within [**] from their appointment, or if a Party fails to appoint a representative within the [**] Day period set forth above, such dispute shall immediately be referred to the Chief Operating Officer (or such other officer as he/she may designate) of each Party who will meet and discuss as necessary in order to try to solve the dispute amicably.  Should the Parties fail to reach a resolution under this Section 12.1, the dispute will be referred to a court of competent jurisdiction in accordance with Section 13.15.

		
	12.2
	Technical Dispute Resolution.

In the event of a dispute (other than disputes in relation to the matters set out in Sections 6.1(b) and 12.1) between the Parties that is exclusively related to technical aspects of the manufacturing, quality control testing, handling, storage or other activities under this Agreement (a "Technical Dispute"), the Parties shall make all reasonable efforts to resolve the dispute by amicable negotiations. In this regard, senior representatives of each Party shall, as soon as practicable and in any event no later than [**] Days after a written request from either Party to the other, confer in good faith to resolve any Technical Dispute. If, despite such efforts, the Parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within [**] Days of such written request, the Technical Dispute shall, at the request of either Party, be referred for determination to a mutually acceptable expert with experience and expertise in the subject matter of the dispute. The costs and expenses of the expert shall be shared equally by the Parties. In the event that the Parties cannot agree whether a dispute is a Technical Dispute, Section 12.1 shall prevail.  For greater certainty, the Parties agree that the release of the Product for sale or distribution pursuant to the applicable marketing approval for such Product shall not by itself indicate compliance by APP with its obligations in respect of the Manufacturing Services and further that nothing in this Agreement shall remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Product are to be released for sale or distribution.

		
	ARTICLE 13
	

MISCELLANEOUS
		
	13.1
	Inventions.

		
	(a)
	For the term of this Agreement, MDCO hereby grants to APP and to any Subcontractor a non-exclusive, paid-up, royalty-free, non-transferable license of MDCO's Intellectual Property which APP and such Subcontractor must use solely for the purpose of performing the Manufacturing Services.

		
	(b)
	All Intellectual Property generated or derived by APP, exclusive of Manufacturing Services Based Intellectual Property, and/or by any Subcontractor in the course of performing the Manufacturing Services, to the extent it is specific to the development, manufacture, use and sale of the Product that is the subject of the Manufacturing Services, shall be the exclusive property of MDCO.

		
	13.2
	Intellectual Property.

Subject to Section 13.1, all Intellectual Property of MDCO shall be owned by MDCO and all Intellectual Property of APP or its Affiliates shall be owned by APP. Neither Party has, nor shall it acquire, any interest in any of the other Party's Intellectual Property unless otherwise expressly agreed to in writing signed by an authorized representative of each Party. Each Party agrees not to use any prior Intellectual Property of the other Party, except as specifically authorized by the other Party or as required for the performance of its obligations under this Agreement. 
		
	13.3
	Insurance.

Each Party shall maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that Party under this Agreement through the term of this Agreement and for a period of 1 (one) year thereafter, which insurance shall afford limits of not less than (i) $[**] for each occurrence for personal injury or property damage liability; and (ii) $[**] in the aggregate per annum with respect to product and completed operations liability.  If requested each Party will provide the other with a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and the limits of liability.  The insurance certificate shall further provide for a minimum of thirty (30) days' written notice to the insured of a cancellation of, or material change in, the insurance.  If a Party is unable to maintain the insurance policies required under this Agreement through no fault on the part of such Party, then such Party shall forthwith notify the other Party in writing and the Parties shall in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances.
		
	13.4
	Independent Contractors.

The Parties are independent contractors and this Agreement shall not be construed to create between APP 

and MDCO any other relationship such as, by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners or any similar relationship, the existence of which is expressly denied by the Parties hereto.
		
	13.5
	No Waiver.

Either Party's failure to require the other Party to comply with any provision of this Agreement shall not be deemed a waiver of such provision or any other provision of this Agreement, with the exception of Sections 6.1.
		
	13.6
	Assignment and Subcontracting.

		
	a)
	Neither Party may assign this Agreement or any of its rights or obligations hereunder except with the written consent of the other Party, such consent not to be unreasonably withheld. It is agreed upon between the Parties that APP may arrange for the Manufacturing Services to be performed by the aforementioned Subcontractor.  

		
	b)
	Notwithstanding the foregoing provisions of this Section 13.6, either Party may assign this Agreement to any of its Affiliates or to a successor to or purchaser of all or substantially all of its business, provided that such assignee executes an agreement with the non-assigning Party hereto whereby it expressly assumes in writing those rights, duties and obligations under this Agreement and this Agreement itself and the assignee is a financially capable business entity.

		
	c)
	Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns.  Any assignment or transfer in contravention of the terms of this Agreement shall be null and void.

13.7Force Majeure.

Neither Party shall be liable for the failure to perform its obligations under this Agreement if such failure is occasioned by a cause or contingency beyond such Party's reasonable control, including, but not limited to, strikes or other labour disturbances, lockouts, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or delay in transportation, defective equipment, lack of or inability to obtain fuel, power or components or compliance with any order or regulation of any government entity acting within colour of right (a "Force Majeure Event").  A Party claiming a right to excused performance under this Section 13.7 shall immediately notify the other Party in writing of the extent of its inability to perform, which notice shall specify the occurrence beyond its reasonable control that prevents such performance.  Neither Party shall be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due and payable under this Agreement.
		
	13.8
	Notices.

Any notice, approval, instruction or other written communication required or permitted hereunder shall be sufficient if made or given to the other Party by personal delivery, by facsimile (fax) communication, or confirmed receipt email or by sending the same by first class mail, postage prepaid to the respective addresses or facsimile (fax) numbers or electronic mail addresses set forth below:

If to MDCO:
The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
Attention:  Mr. Paul Antinori
Senior Vice President and General Counsel 
Facsimile (fax) number:  862-207-6062
Email address:  Paul.Antinori@themedco.com

If to MDCO (for accounting purposes):
The Medicines Company
8 Sylvan Way

Parsippany, NJ 07054
Attention:  Mr. Bill O'Connor
Chief Accounting Officer
Facsimile (fax) number: 862-207-6094
Email address:  Bill.O'Connor@themedco.com

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

or to such other addresses, facsimile numbers or electronic mail addresses provided to the other Party in accordance with the terms of this Section 13.8.  Notices or written communications made or given by personal delivery, facsimile or electronic mail shall be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five (5) days after being deposited in the European Union mail, postage prepaid or upon receipt, whichever is sooner.

		
	13.9
	Severability.

If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such determination shall not impair or affect the validity, legality or enforceability of the remaining provisions hereof, and each provision is hereby declared to be separate, severable and distinct. The Parties shall endeavor, in due form, to replace the invalid or void provision with a new provision or to fill the gap with a provision which best enables the economic purpose pursued to be achieved.
		
	13.10
	Entire Agreement.

This Agreement, together with the Quality Agreement, constitutes the full, complete, final and integrated agreement between the Parties hereto relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions or understandings with respect to the subject matter hereof.  Any modification, amendment or supplement to this Agreement must be in writing and signed by authorized representatives of both 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. THE TERMS OF ANY PURCHASE ORDER, ACKNOWLEDGMENT OR SIMILAR STANDARDIZED FORM GIVEN OR RECEIVED IN THE CONTEXT OF THE SUBJECT MATTER OF THIS AGREEMENT WHICH ARE IN ADDITON TO OR INCONSISTENT WITH THE TERMS OF THIS AGREEMENT WILL HAVE NO EFFECT AND SUCH TERMS AND CONDITIONS ARE HEREBY EXPRESSLY EXCLUDED.
		
	13.11
	Other Terms.

No terms, provisions or conditions of any purchase order or other business form or written authorization used by MDCO or APP will have any effect on the rights, duties or obligations of the Parties under or otherwise modify this Agreement, regardless of any failure of MDCO or APP to object to such terms, provisions, or conditions unless such document specifically refers to this Agreement and is signed by both Parties.
		
	13.12
	No Third Party Benefit or Right.

For greater certainty, nothing in this Agreement shall confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Agreement.
		
	13.13
	Execution in Counterparts.

This Agreement may be executed in two or more counterparts, by original or facsimile signature, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

		
	13.14
	Use of MDCO Name

APP shall not make any use of MDCO's name, trademarks or logo or any variations thereof, alone or in connection with any other word or words, without the prior written consent of MDCO, which consent shall not be unreasonably withheld.  
		
	13.15
	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.

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

APP PHARMACEUTICALS, LLC
by _/s/ J.R. Ducker____________
 J.R. Ducker
President and CEO
THE MEDICINES COMPANY
by _/s/ Glenn Sblendorio__________
 Glenn Sblendorio, EVP and CFO

SCHEDULE A
MINIMUM RUN QUANTITY, AND Price
A) MINIMUM RUN QUANTITY
	
		
	PRODUCT
	MINIMUM RUN QUANTITY

	Angiomax®
	*

B) PRICE
	
					
	Product
	Fill Volume
	Vial size
	Batch size proposed
	Unit Total Price

	Angiomax®
	250 mg
	10 ml
	[**] vials
	$[**] 
per vial 

* To be determined by the Parties in good faith prior to the Initial Supply Term.

SCHEDULE B

STABILITY TESTING activities
APP and MDCO shall agree in writing on any stability testing to be performed by APP in connection with the Product.  Such agreement shall specify the commercial and Product stability protocols applicable to the stability testing.

SCHEDULE C
ACTIVE MATERIALS
	
	
	Active Materials

	Bivalirudin

SCHEDULE D
DEVELOPMENT COSTS AND EXPENSES
	
								
	Transfer Expense
	Cost per Unit
	Units
	Total
	 

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	Total
	$[**]
	 

	 
	 
	 
	 
	 

	[**]
	 
	$[**]
	 

SCHEDULE E
CAPITAL EXPENDITURES
	
						
	CapEx
	Cost per Unit
	Units
	Total
	 

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	Total
	$[**]
	 

	 
	 
	 
	 
	 
	 

	[**]
	 
	$[**]

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00204-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00204-of-00352.parquet"}]]