Document:

MDCO EX 10.3 09.30.2011

Exhibit 10.3

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

LICENSE AGREEMENT

BY AND AMONG

THE MEDICINES COMPANY 

AND

TEVA PHARMACEUTICALS USA, INC.

DATED AS OF SEPTEMBER 30, 2011

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this “Agreement”) is entered into as of September 30, 2011 (the “Effective Date”) by and between 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 Teva Pharmaceuticals USA, Inc., a corporation organized and existing under the laws of the State of Delaware with offices located at 1090 Horsham Road, North Wales, Pennsylvania 19454 and its Affiliates (collectively “Teva”).  Each of MDCO and Teva is sometimes referred to herein, individually, as a “Party” and, collectively, as the “Parties.”
  
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, Pliva Hrvatska d.o.o., through Barr Laboratories, Inc. as its filing agent, submitted Abbreviated New Drug Application No. 91-206 (the “Teva 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 which is the subject of the Teva ANDA;
WHEREAS, Teva subsequently amended the Teva ANDA to include a “paragraph IV certification” seeking approval to engage in the manufacture, use and sale of the Teva Product (as defined below) prior to the expiration of United States Patent Nos. 7,582,727 and 7,598,343 (the “Litigated Patents”);
WHEREAS, Teva admits that the Teva Product infringes the Litigated Patents and that the Litigated Patents are valid and enforceable;
WHEREAS, MDCO and Teva are parties to a certain Settlement Agreement of even date herewith (the “Settlement Agreement”), pursuant to which MDCO and Teva are settling pending litigation; and
WHEREAS, pursuant to the Settlement Agreement, MDCO and Teva 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.    “Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the rules, regulations and guidelines promulgated thereunder.
1.4.    “Adverse Drug Experience” has the meaning set forth in 21 C.F.R. § 314.80(a), as amended, supplemented or superseded from time to time.
1.5.    “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.  In addition, with respect to this Agreement and the Settlement Documents, Teva Parenteral Medicines, Inc., Teva Pharmaceutical Industries Limited, Pliva Hrvatska d.o.o., Pliva d.d., Barr Laboratories, Inc., Barr Pharmaceuticals, Inc., Barr Pharmaceuticals, LLC, Plantex USA Inc., and Plantex, Ltd, and their respective Affiliates, shall be deemed Affiliates of Teva Pharmaceuticals USA, Inc. 
1.6.    “AG Product” means a generically Labeled lyophilized product that is Marketed and/or supplied under NDA No. 20-873, described therein now or hereafter.
1.7.    “Agreement” shall have the meaning assigned to such term in the preamble to this Agreement.
1.8.    “ANDA” means an Abbreviated New Drug Application to the FDA for approval to Manufacture and/or Market a pharmaceutical product in the Territory.
1.9.    “Angiomax” means the pharmaceutical product, solely in the lyophilized powder form, that contains the Compound as its sole active ingredient which is approved for Marketing in the Territory pursuant to MDCO’s NDA and is currently sold under the tradename Angiomax.
1.10.    “Anticipated Launch Date” means June 30, 2019.
1.11.    “API Supply Agreement” shall have the meaning assigned to such term in the Settlement Agreement. 
1.12.    “Applicable Law” means the applicable Laws, rules, regulations, guidelines and requirements of any Governmental Authority related to the development, registration, Manufacture and Marketing of the Teva Product in the Territory or the performance of either Party’s obligations under this Agreement.
1.13.    “[**]” means the [**].
1.14.    “[**]” means the [**].

1.15.    “Authorized AG Product” means an AG Product 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.  
1.16.    “Authorized Generic ANDA Product” means [**].
1.17.    “Authorized Launch Date” means the earlier of: [**]. 
1.18.    “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.
1.19.    “Claim” means any Third Party claim, lawsuit, investigation, proceeding, regulatory action or other cause of action. 
1.20.    “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.  
1.21.    “Compound” means bivalirudin.
1.22.    “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.
1.23.    “Consent Judgment” shall have the meaning assigned to such term in the Settlement Agreement.
1.24.    “Covenant Not to Sue” shall have the meaning assigned to such term in Section 3.5.
1.25.    “[**]” means [**].
1.26.    “Effective Date” shall have the meaning assigned to such term in the preamble to this Agreement.
1.27.    “FDA” means the United States Food and Drug Administration or any successor agency thereof.
1.28.    “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).
1.29.    “[**]” means [**].

1.30.    “[**]” means [**].
1.31.    “[**]” a [**].
1.32.    “First Commercial Sale” means the shipment of commercial quantities of product for immediate commercial sale to major retail chains, major pharmaceutical wholesalers, hospitals or managed care providers in the Territory, [**].
1.33.    “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.
1.34.    “GAAP” means generally accepted accounting principles in effect in the United States from time to time, consistently applied.
1.35.    “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. 
1.36.    “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.
1.37.    “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.
1.38.    “Launch” means the first Shipment of Teva Product by Teva to an unaffiliated Third Party.
1.39.    “Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders, judgments and/or ordinances of any Governmental Authority.
1.40.    “License and Authorization” shall have the meaning assigned to such term in Section 2.2.
1.41.    “Litigated Patents” shall have the meaning assigned to such term in the Recitals.
1.42.    “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.
1.43.    “Manufacture” means all activities related to the manufacturing 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.
1.44.    “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.
1.45.    “MDCO” shall have the meaning assigned to such term in the preamble to this Agreement.
1.46.    “MDCO Liability” shall have the meaning assigned to such term in Section 9.1.
1.47.    “MDCO Party” shall have the meaning assigned to such term in Section 9.2.
1.48.    “MDCO’s External Auditor” shall have the meaning assigned to such term in 6.7.
1.49.    “MDCO’s NDA” means MDCO’s NDA No. 20-873 for the Regulatory Approval of Angiomax.
1.50.    “MDCO’s Patents” means (i) the Litigated Patents and any patent that issues as a result of a reexamination or reissue thereof, (ii) except for the ‘404 Patent, any other present or future U.S., international, or foreign patent owned or controlled by MDCO or any of its Affiliates which claims cover the Manufacturing, Marketing, using, or importing of the Teva Product. 
1.51.    “NDA” means a New Drug Application filed with the FDA pursuant to and under 21 U.S.C. § 355(b), together with the FDA’s implementing rules and regulations.
1.52.    “Net Sales” shall equal the gross amount invoiced for sales of the Teva Product by Teva to Third Parties in the Territory less the following, deductions from such gross sales, all as determined in accordance with Teva’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 Teva Product by Teva to Third Parties in the Territory in accordance with GAAP: 
1.52.1    [**] percent ([**]%) of gross sales for cash discounts;
1.52.2    reasonable 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 Teva Product;
1.52.3    reasonable estimates for customer returns of Teva Product (including as a result of recalls);
1.52.4    reasonable estimates for rebates or other price reductions provided, based on sales of Teva Product to any governmental or regulatory authority in respect of state or federal Medicare, Medicaid or similar programs; and
1.52.5    reasonable estimates for billing adjustments, price or shelf stock adjustments, or other promotional allowances.
1.53.    “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.
1.54.    “Party” or “Parties” shall have the meaning assigned to such term in the preamble to this Agreement. 
1.55.    “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. 
1.56.    “Pending Litigation” shall have the meaning assigned to such term in the Settlement Agreement.
1.57.    “Person” means any individual, partnership, association, corporation, limited liability company, trust, or other legal person or entity.
1.58.    “Regulatory Approval” means final Marketing approval by the FDA for the sale and Marketing of a pharmaceutical product in the Territory.
1.59.    “Settlement Agreement” shall have the meaning assigned to such term in the Recitals.
1.60.    “Settling Party” shall have the meaning assigned to such term in Section 13.5.
1.61.    “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 to consumers; in each instance, a “Shipment” “Ship” or “Shipping” shall have the correlated meaning.
1.62.    “Term” shall have the meaning assigned to such term in Section 12.1.
1.63.    “Territory” means the United States of America, and its territories, commonwealths, districts and possessions, including the Commonwealth of Puerto Rico.

1.64.    “Teva” shall have the meaning assigned to such term in the preamble to this Agreement.
1.65.    “Teva ANDA” shall have the meaning assigned to such term in the Recitals.
1.66.    “[**]” means [**] and their respective Affiliates.
1.67.    “Teva Launch Date” means the earlier of:
1.67.1    the Anticipated Launch Date;
1.67.2    an Authorized Launch Date; 
1.67.3    [**]
1.67.4    [**].
1.68.    “Teva Liability” shall have the meaning assigned to such term in Section 9.2.
1.69.    “Teva Party” shall have the meaning assigned to such term in Section 9.1.
1.70.    “Teva Product” means a lyophilized product containing the Compound as its sole active ingredient, which is the subject of the Teva ANDA, including all lyophilized formulations thereof, described therein now or hereafter.
1.71.    “Teva Product Manufacturing Costs” for Teva Product shall mean, [**].
1.72.    “Teva Product Gross Profits” means the Net Sales for Teva Product less the Teva Product Manufacturing Costs incurred by Teva for such Teva Product.
1.73.    “Teva’s Patents” means any present or future U.S., international, or foreign patent owned or controlled by Teva which claims cover the Manufacturing, Marketing, using, or importing of Angiomax, AG Product and/or Generic Equivalent Product.
1.74.    “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” (the “Orange Book”) as may be amended from time to time during the Term.
1.75.    “Third Party” or “Third Parties” means any Person or entity other than a Party or its Affiliates.
2.License and Authorization
2.1.    Subject to the terms, conditions and limitations hereof, including the conditions set forth in Section 3, MDCO hereby grants to Teva a non-exclusive license, under 

MDCO’s Patents to: (i) Manufacture, have Manufactured, import and Market the Teva Product in or for the Territory, on and after the applicable Teva Launch Date; and (ii) Manufacture, and have Manufactured, import and conduct regulatory activities regarding Teva Product prior to the Teva Launch Date (but not to Market (except as provided in Section 3.1) or Ship the Teva Product prior to the Teva Launch Date) in sufficient quantities for the Launch of Teva Product and to permit Teva to Market and Ship the Teva Product beginning on and after the Teva Launch Date.  To the extent MDCO owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval of the Teva Product or Teva’s Manufacture, importing or Marketing of Teva Product in the Territory as permitted hereunder, MDCO hereby waives, effective as of the date that Teva is licensed to conduct the applicable activity hereunder, such exclusivities and shall, if requested by Teva and if applicable, send the FDA, a written confirmation of MDCO’s agreement to waive, effective as of the date that Teva is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Teva Product and/or the Teva ANDA; provided, however, that the foregoing waiver shall not apply with respect to any pediatric exclusivity attached to the ‘404 Patent.  
2.2.    The license, waiver and authorization granted in Sections 2.1 and 3.1 of this Agreement are referred to herein as the “License and Authorization.”  Except to the extent permitted pursuant to Section 13.3, and without derogating from Teva’s “have Manufactured” rights set forth in Section 2.1, Teva shall not have the right to sublicense, assign or transfer any of its rights under the License and Authorization. 
2.3.    [**].
2.4.    Except 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 Teva to Market or Manufacture any Generic Equivalent Product except under the Teva ANDA.  Nothing herein shall be construed as the granting or 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, MDCO explicitly retains the right itself or through an Affiliate to Market an 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.
2.5.    In the event MDCO authorizes, whether pursuant to a license, supply arrangement, covenant not to sue, release, waiver or the like (other than the granting of a retroactive license, covenant not to sue, release, waiver or the like, to a Third Party with respect to past Marketing or Manufacturing of a Generic Equivalent Product (including the future Marketing of Generic Equivalent Product already Manufactured or in the processes of being Manufactured)), a Third Party [**] to sell a Generic Equivalent Product or an Authorized AG Product [**], MDCO shall inform Teva [**].
3.Conditions
3.1.    Teva hereby agrees that it shall not Market or Ship Teva Product in the Territory prior to the applicable Teva Launch Date.  Notwithstanding the foregoing, Teva shall be 

permitted (i) [**] days in advance of the Anticipated Launch Date [**] to inform potential customers of the date on which Teva would be permitted to sell the Teva 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 Teva Product. 
3.2.    Teva hereby agrees not to (i) challenge 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 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) subject to Section 3.11, Market or Manufacture a Generic Equivalent Product other than the Teva Product pursuant to the License and Authorization; or (iv) subject to Sections 3.10 and 3.11, 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 Teva Product.  This Section 3.2 will automatically terminate upon the earlier of [**].
3.3.    In addition to any other right or remedy MDCO may be entitled to, in the event that during the Term, Teva breaches Section 3.2, MDCO may, at its sole discretion, immediately, effective upon notice to Teva, terminate the API Supply Agreement, and/or this Agreement.  If MDCO terminates this Agreement pursuant to this Section 3.3, Section 4 shall survive such termination.
3.4.    Nothing 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 Teva by the FDA in connection with the Teva ANDA or the Teva Product.  Nothing set forth herein or in the other Settlement Documents shall be deemed to prevent or restrict Teva from Manufacturing or Marketing any Generic Equivalent Product which would not infringe MDCO’s Patents, and nothing herein shall prohibit Teva from entering into any agreement with a Third Party related to any Generic Equivalent Product that does not infringe MDCO’s Patents.  
3.5.    MDCO hereby covenants that it will not sue, assert any claim or counterclaim against, otherwise participate in any action or proceeding against Teva or its Affiliates or any of their shareholders, licensees, sublicensees, customers, suppliers, importers, manufacturers, distributors, 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 sale, offer for sale, or importation of the Teva Product (and for clarity, the Compound used to Manufacture the Teva Product), in or for the Territory, infringes MDCO’s Patents insofar as MDCO’s Patents apply to the Teva ANDA or the Teva 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 Teva has violated either of the Consent 

Judgments or has materially breached this Agreement or the Settlement Agreement.  For any U.S. patents subject to the Covenant Not to Sue and listed in the FDA Orange Book, the Covenant Not to Sue will hereby be treated as a non-exclusive license, so that Teva or its Affiliates may file and maintain with the FDA “Paragraph IV Certifications” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 U.S.C. § 355(b)(2)(A)(iv) with respect thereto. 
3.6.    In consideration of the mutual execution of the Settlement Documents and the mutual agreement to be legally bound by the terms hereof, MDCO and Teva, 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) Teva’s making, using, selling, offering for sale or importing Compound anywhere in the world for purposes of selling Compound to Teva’s customers prior to the Effective Date, (iii) associated with the Teva ANDA and Teva Product, and including without limitation MDCO’s assertion of the Litigated Patents against Teva, 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 or 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.  In connection with this Agreement, each Party, on behalf of itself and its Affiliates, expressly waive and relinquish all rights and benefits afforded in any jurisdiction similar to those afforded in Section 1542 of the California Civil Code, which provides as follows: 
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN TO HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.
3.7.    Except to the extent required by court order or other Applicable Law, Teva shall not release any agent or consultant (whether retained by Teva or by any attorney that represents Teva) to assist or cooperate with any current or future litigant in a litigation against MDCO with respect to the Litigated Patents, the ‘404 Patent, or otherwise with respect to Angiomax in the Territory and shall not release, grant a waiver of conflict of interest or otherwise take any action which would allow or permit any attorney who represented Teva in the Pending Litigation (i) to breach the confidentiality of non-public information to which such attorney had access in connection with the Pending Litigation; or (ii) to represent or otherwise assist any current or future litigant in a litigation against MDCO with respect to the Litigated Patents, the 

‘404 Patent and Angiomax in the Territory.  
3.8.    Except as required by Law or for purposes of patient safety, MDCO will not, and will not cause, support or authorize any Person to (i) delete, remove or cancel NDA No. 20-873 for so long as Teva is selling Teva Product or AG Product, or (ii) in any regulatory, judicial or other forum or before any governmental agency challenge or contest the first to file exclusivity under 21 U.S.C. § 355(j)(5)(B)(iv) (as amended or replaced) with respect to the Teva ANDA.
3.9.    At the request of Teva, MDCO will submit appropriate and necessary documentation to the FDA evidencing the licenses, waivers and covenants granted to Teva under this Agreement.  
3.10.    Subject to the remainder of this Section 3.10, Teva hereby agrees that  Teva shall not supply the Compound to any Third Party which Teva knows or has reason to know will be used to Manufacture a Generic Equivalent Product that is intended for Marketing or use in the Territory.  Teva shall require that any Third Party, [**], to whom Compound is delivered pursuant to Section 3.10.1(i) below, agree not to use such Compound to Manufacture a Generic Equivalent Product that is intended for Marketing or use in the Territory except as permitted under Section 3.10.1.  In the event Teva or MDCO becomes aware that Compound Manufactured by Teva is used by a Third Party to Manufacture a Generic Equivalent Product that is intended for use in the Territory other than as contemplated by this Section 3.10, Teva will immediately cease the supply of Compound to such Third Party.  
3.10.1    Notwithstanding the foregoing or anything else to the contrary in this Agreement or the other Settlement Documents, nothing in the Settlement Documents will prohibit or restrict Teva from: [**].
3.10.2    MDCO hereby covenants that it will not sue, assert any claim or counterclaim against Teva or its Affiliates or any of their shareholders, licensees, sublicensees, suppliers, importers, manufacturers, 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, otherwise participate in any action or proceeding, in each case claiming or otherwise asserting that, the foregoing activities set forth in Sections 3.10.1 infringe MDCO’s Patents , and MDCO hereby prospectively releases Teva and the foregoing Persons from liability under MDCO’s Patents with respect to the foregoing activities set forth in Sections 3.10.1.  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.  This covenant not to sue shall not apply in the event Teva has violated either of the Consent Judgments or has breached this Agreement or the Settlement Agreement.  In addition to any other right or remedy MDCO may be entitled to, in the event that (i) Teva breaches this Section 3.10, or (ii) Compound supplied by Teva is used in a Generic Equivalent Product sold in the Territory by a Third Party [**] prior to: 

[**], MDCO may, at its sole discretion, immediately, effective upon notice to Teva, terminate the API Supply Agreement and/or this Agreement.
3.11.    Notwithstanding anything set forth herein or in the other Settlement Documents, if Teva acquires all or substantially all the assets and business (by merger, purchase, reorganization, reincorporation, or otherwise) of a Third Party that owns an ANDA filed with the FDA seeking Regulatory Approval of a Generic Equivalent Product (an “Acquired Company ANDA”, and such acquisition an “ANDA Company Acquisition”), Teva reserves the right to, prior to the closing of such ANDA Company Acquisition, divests such Acquired Company ANDA and the Parties agree that the Third Party acquirer of such Acquired Company ANDA shall not be subject to the terms and conditions of the Settlement Documents.  In addition, Teva shall have the right to withdraw and abandon the Acquired Company ANDA promptly following the closing of the ANDA Company Acquisition without being in breach of the Settlement Documents, and Teva shall promptly following the closing date of such ANDA Company Acquisition, provide notice to MDCO confirming the withdrawal and abandonment of the Acquired Company ANDA .
4.License to Teva’s Patents
4.1.    In full and complete consideration of the license and covenant not to sue granted by Teva to MDCO in this Section 4, MDCO shall make a one-time payment to Teva of [**] United States dollars ($[**]) within five (5) Business Days of the Effective Date.  The foregoing payment shall be made by wire transfer to the account designated by Teva.
4.2.    Teva hereby grants to MDCO an exclusive (except as to Teva), sublicensable, fully paid-up license, under Teva’s Patents to: (i) Manufacture, have Manufactured, and import Angiomax, AG Product and Generic Equivalent Product in or for the Territory; and (ii) Market Angiomax, AG Product and Generic Equivalent Product in the Territory.  For clarity, the foregoing grant of such exclusivity shall not preclude Teva from Manufacturing, importing and Marketing Generic Equivalent Product itself and Manufacturing Generic Equivalent Product for others.
4.3.    Teva shall promptly inform MDCO in writing of any infringement of Teva’s Patents by a Third Party with respect to the Manufacturing and/or Marketing of Angiomax, AG Product or Generic Equivalent Product in or for the Territory (the “MDCO Field”) of which Teva has knowledge, and shall provide MDCO with any readily available information relating to such infringement.
4.4.    During the Term, MDCO shall have the right, but not obligation, to prosecute at its own expense all infringements of Teva’s Patents in the MDCO Field and, in furtherance of such right, Teva hereby agrees that MDCO may include Teva as a named party plaintiff in any such suit, without expense to MDCO.  The total cost of any such infringement action commenced or defended solely by MDCO shall be borne by MDCO, and MDCO shall keep any recovery or damages derived therefrom. 
4.4.1    In the event that any action alleging invalidity of any of Teva’s 

Patents shall be brought against Teva or MDCO, MDCO shall have the right, but not the obligation, to participate in the defense of such action at its own expense, and Teva shall not enter into any settlement of such action that would derogate from the scope of the license granted to MDCO hereunder without MDCO’s prior written consent.
4.4.2    In any infringement suit as MDCO may institute to enforce Teva’s Patents in the MDCO Field pursuant to this Agreement, Teva shall, at the request and expense of MDCO, cooperate in all reasonable respects and make available relevant records, papers, information, samples, specimens, and the like.
4.4.3    Teva retains the right to enforce Teva’s Patents outside of the MDCO Field, and in the event that MDCO chooses not to enforce Teva’s Patents with respect to infringement within the MDCO Field, MDCO will notify Teva within one hundred twenty (120) days following the date that MDCO becomes aware of such infringement and Teva shall have the right, but not the obligation, to enforce Teva’s Patents with respect to such infringement and keep any recovery or damages derived therefrom.
4.5.    Teva hereby covenants that it will not sue, assert any claim or counterclaim against, otherwise participate in any action or proceeding against MDCO or any of its shareholders, licensees, sublicensees, customers, suppliers, importers, manufacturers, distributors, 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, use sale, offer for sale, or importation of Angiomax, or any other product in a lyophilized powder form containing the Compound as its sole active ingredient (and for clarity, the Compound used to Manufacture such products), in or for the Territory, infringes Teva’s Patents.  Teva will impose the foregoing covenant on any Third Party to which Teva may assign, exclusively license or otherwise transfer any of Teva’s Patents subject to the foregoing covenant.
5.Marketing of Teva Product
5.1.    During any period Teva is paying a royalty under Sections 6.1 or 6.2, Teva shall, at its sole cost and expense, utilize Commercially Reasonable Efforts in Marketing the Teva Product in the Territory to maximize sales of Teva Product.  During the Term prior to the Teva Launch Date regarding the Marketing of Teva Product, Teva shall not enter into any arrangements or agreements with any Third Party to Market Teva Product in the Territory without MDCO’s prior written consent, which shall not be unreasonably withheld, except that Teva 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. 
5.2.    Except as provided in Section 13.3, only Teva shall be permitted to Launch and Market Teva Product under this Agreement.
5.3.    It is the intent of Teva to seek to sell Teva Product so as to maximize Teva 

Product Gross Profits.  Teva will have sole discretion, however, in setting the price for the sale of the Teva Product in the Territory.  Teva will also agree that if it prices Teva 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 Teva Product shall be adjusted to reverse any discount which was given to a customer that was in excess of customary discounts for the Teva Product (or, in the absence of relevant data for this Teva Product, other similar products under similar market conditions).
6.Royalties
6.1.    Teva Product.  Teva will pay to MDCO a royalty of [**] percent ([**]%) of Teva Product Gross Profits on Teva Product sold [**]. 
6.2.    [**].  Teva will pay to MDCO a royalty of [**] percent ([**]%) of Teva Product Gross Profits on Teva Product sold [**].  In the event that the Teva Product Gross Profits on Teva Product for any calendar quarter is less than zero, Teva shall be permitted to set off the difference between zero and such Teva Product Gross Profits against future amounts payable by Teva pursuant to this Section 6.2 in future calendar quarters.
6.3.    Royalty Payments.  Payments due under this Section 6 shall be made within [**] days from the end of each calendar quarter in which Teva Product is sold.  All such payments shall include a report detailing the calculation of gross sales, Net Sales, Teva Product Gross Profits and the royalties payable hereunder.  
6.4.    Annual True-Up. Within one hundred and eighty (180) days after the end of the last calendar year during the Term in which fees are payable to MDCO pursuant to this Section 6, Teva 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 1.51.2, 1.51.4 and 1.51.5.  The reconciliation shall be based on actual cash paid or credits actually issued plus an estimate for any remaining liabilities incurred related to Teva 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 thirty (30) days of the date of delivery of such report. 
6.5.    Final True-Up.  Within twenty-five (25) months of the after the end of the last calendar year during the Term in which fees are payable to MDCO pursuant to this Section 6, Teva 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 1.51.3.  The reconciliation shall be based on actual cash paid or credits issued for returns, through the twenty-four (24) 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 thirty (30) days of the date of delivery of such report.
6.6.    Maintenance of Records.  During the Term, and for a period of three (3) 

years thereafter, Teva 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:
6.6.1    records and books of account sufficient to confirm the calculation of the gross sales, Net Sales, AG Product Gross Profits (as applicable), Teva Product Gross Profits (as applicable), and the royalties payable hereunder; and 
6.6.2    information and data contained in any invoices or reports accompanying any payment to MDCO provided to MDCO in connection with this Agreement.
6.7.    Inspection.  On no less than [**] Business Days notice from MDCO, Teva shall make all the records, books of account, information and data referred to in Section 6.7 of this Agreement available for inspection during normal business hours by an internationally recognized independent accounting firm selected by MDCO and reasonably acceptable to Teva 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 Teva 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 Teva. Any underpayment of amounts due hereunder as reflected by MDCO’s External Auditor’s results shall be promptly paid by Teva to MDCO.  
6.8.    Inspection 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 Teva shall be solely responsible for the cost of such review and audit and shall pay MDCO any payment due.  All information disclosed by Teva or its Affiliates pursuant to this Section 6 shall be deemed Confidential Information.
6.9.    Payment Method.  All payments to be made by Teva 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.
6.10.    Late 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.
6.11.    Taxes.  MDCO shall be responsible for and shall pay all taxes payable on any income or any payments by Teva to MDCO.  Teva 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.  Teva 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.  Teva shall secure and promptly send to MDCO proof of such taxes, duties or other levies withheld and paid by Teva 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.
7.    Confidentiality
7.1.    Confidentiality 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:
7.1.1    at the time of disclosure by one Party to the other, in the public domain or otherwise publicly known;
7.1.2    after disclosure by one Party to the other becomes part of the public domain, other than by breach by a Party of any obligation of confidentiality;
7.1.3    information 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
7.1.4    received from a Third Party who was lawfully entitled to disclose such information free of an obligation of confidentiality.
7.2.    Exceptions.  Notwithstanding Section 7.1, in addition to any disclosure allowed under Section 13.5 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.
7.3.    Expiration of Confidentiality.  The confidentiality obligation contained in this Section 7 shall survive the termination or expiry of this Agreement for so long as such information remains confidential.

7.4.    Disclosure.  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 Teva Product or practices associated with the Teva 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 Teva Product or practices associated with the Teva Product.  
7.5.    Enforcement.  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.
8.    Representations and Warranties of Parties
MDCO represents and warrants to Teva that MDCO possess the rights and authority to grant the License and Authorization to Teva and its Affiliates under this Agreement, and Teva represents and warrants to MDCO that Teva possess the rights and authority to grant MDCO the license and associated rights set forth in Section 4, and with respect to Sections 8.1 and 8.2 below, each of MDCO and Teva represents, warrants, and covenants, to the other Party that:
8.1.    Organization 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.
8.2.    Consents and Approvals; No Violations. 
8.2.1    Except 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.
8.2.2    Neither 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.
8.2.3    The 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.  
9.    Indemnities; Product Liability; Insurance
9.1.    Indemnity by MDCO.  MDCO shall defend, indemnify and hold harmless each of Teva and its Affiliates and its and their directors, officers, employees and contractors (“Teva Party”) from and against any and all Losses, (“MDCO Liability”) arising from or in connection with:
9.1.1    any Claim resulting from any negligent acts or acts of willful misconduct of any MDCO Party in connection with the performance of its obligations under this Agreement; or
9.1.2    the 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 Teva Party.
9.2.    Indemnity by Teva.  Teva 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 (“Teva Liability”) arising from or in connection with:
9.2.1    any Claim resulting from any negligent acts or acts of willful misconduct of any Teva Party in connection with the performance of its obligations under this Agreement; 

9.2.2    any Claim based on or arising out of the use, Manufacturing, Labeling, Packaging or Marketing of Teva Product, including, any investigation by a Governmental Authority or any claim for personal injury or property damage asserted by any user of Teva Product; or
9.2.3    the breach by Teva of any of its representations or warranties contained in this Agreement. 
except, in each case, to the extent that Teva’s Liability is caused by the negligence, breach of the terms of this Agreement, or willful misconduct of a MDCO Party.
9.3.    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.
9.4.    No Admissions.  The indemnified Party shall not make any payment or incur any expenses in connection with any Teva 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.
9.5.    Claim Information.  Each Party shall promptly:
9.5.1    inform the other by written notice of any actual or threatened Claim to which Sections 9.1 or 9.2 apply;
9.5.2    provide to the other Party copies of all papers and official documents received in respect of any such Claim; and 
9.5.3    cooperate as reasonably requested by the other Party in the defense of any such Claim.
9.6.    Limitation of Liability.  Except as may be included in a Claim under Section 9.1, 9.2 or 9.8, or a breach by any Party of Section 3 or Section 13.5, in no event shall any Party or its Affiliates be liable for special, punitive, indirect, incidental or consequential loss or damage (including lost profits or revenues associated with MDCO’s breach of its AG Product supply obligations) based on contract, tort or any other legal theory arising out of this Agreement.
9.7.    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 Teva, 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 $5,000,000 per occurrence and $5,000,000 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 six (6) years following the expiry or termination of this Agreement.
9.8.    Irreparable Harm.  Teva acknowledges that in the event of a Launch by Teva of Teva Product in the Territory other than as permitted under this Agreement or a breach of Section 3.10, 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, Teva agrees that in any action by MDCO seeking injunctive or other equitable relief in connection with any such Launch other than as permitted under this Agreement or a breach of Section 3.10, Teva shall not assert or plead the availability of an adequate remedy at Law as a defense to the obtaining of any such remedy.  Teva 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 and the Parties agree that lost profits resulting from lost sales by MDCO of Angiomax are a reasonably foreseeable element of damages which MDCO would suffer and to which, notwithstanding anything to the contrary set forth herein, MDCO will be entitled to recover in accordance with the Law.
9.9.    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.
10.    Force Majeure
10.1.    Force 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 10.2, 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.
10.2.    Continued 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. 
11.    Trademarks and Trade Names
11.1.    Except as may appear on the AG Product vials, Labeling and Packaging, Teva 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.
12.    Term and Termination
12.1.    Term.  Unless sooner terminated in accordance with the terms hereof, the term of this Agreement shall extend from the Effective Date until the expiration of all of the MDCO’s Patents (the “Term”).
12.2.    Termination.  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:
12.2.1    the 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 12.2; or 
12.2.2    an 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. 
12.3.    Effect 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. 
12.4.    Liability 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.
12.5.    Surviving Sections.  The provisions of Sections 1, 3.6, 6.5 through 6.11, 7, 8, 9, and 13 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 Teva has violated the Consent Judgment or has materially breached this Agreement or the Settlement Agreement, the Covenant Not to Sue and the final paragraph of Section 3.11 shall survive termination or earlier expiration of this Agreement.
13.    Miscellaneous

13.1.    Notice.  
13.1.1    Any 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 13.2 below unless a different address or fax number has been notified to the other in writing for this purpose.
13.1.2    Each 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.

13.2.    Address 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:

with a copy to:

The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
Attn: General Counsel
Facsimile:

	To Teva 
Teva Pharmaceuticals USA, Inc. 
1090 Horsham Road 
PO Box 1090 
North Wales, PA 19454-1090 
Attn: Chief Executive Officer 
Facsimile: 215-591-8803
with a copy to:
Teva North America  
425 Privet Road  
Horsham, PA 19044  
Attention: General Counsel  
Facsimile: 215-293-6499

13.3.    Assignment.
13.3.1    Subject to Section 13.3.2, 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. 
13.3.2    Each 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.
13.3.3    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.
13.4.    Amendment.  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.
13.5.    Public 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 without limitation 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 13.5; (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”) the terms set forth in Sections 2 and 6 (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 the MDCO Product 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 6 (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, 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) Teva may disclose such terms to the FDA as may be necessary or useful in obtaining and maintaining Regulatory Approval of the Teva ANDA and Launching the Teva Product as provided by the License Agreement, so long as Teva requests that the FDA maintain such terms in confidence, and (vii) Teva may disclose such terms to its manufacturers and customers in accordance with Teva’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 without 

limitation 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 and API Supply Agreement 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.   
13.6.    Superiority 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:
13.6.1    neither 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;
13.6.2    neither 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; 
13.6.3    this Section 13.6 shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation; and
13.6.4    notwithstanding 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.
13.7.    Governing Law.  This Agreement shall be governed by the Laws of the State of New York without regard to the conflicts of law provisions thereof.  The Parties irrevocably agree that the United States District Court for the Southern District of New York 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 Southern District of New York.  Notwithstanding the foregoing, if there is any dispute for which the United States District Court for the Southern District of New York does not have subject matter jurisdiction, the state courts in the State, City and County of New York, 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, City and County of New York.  
13.8.    Agreement Costs.  Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion of this 

Agreement.
13.9.    Counterparts.  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.
13.10.    Severability.  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.
13.11.    Relationship 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 Teva.  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.     
13.12.    Construction.  The language in all parts of this Agreement shall be construed, in all cases, according to its fair meaning.  MDCO and Teva 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 “Teva shall” or “Teva will” herein shall also mean “Teva 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. 
13.13.    Dispute Resolution.
13.13.1    Preliminary 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.
13.13.2    Escalation 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 Teva and MDCO Presidents (or other ranking senior executive) for resolution.  
13.13.3    Equitable Relief.  Nothing in this Section 13.13 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 13.13.
13.14.    Cumulative 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.
13.15.    No Third Party Benefit.  This Agreement shall be binding upon and enure 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.
13.16.    Further 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.
13.17.    Waiver.  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: _9/30/11________        By: _/s/ Glenn Sblendorio___________________

Name: ___Glenn Sblendorio_________________
                    
Title: __EVP & CFO________________________

TEVA PHARMACEUTICALS USA, INC.

Date: September 30, 2011__        By: _/s/ Deborah A. Griffin___________________

Name: __Deborah A. Griffin__________________
                    
Title: __VP & CFO__________________________

Date: _September 28, 2011__     By: _/s/ David M. Stark________________________

Name: _David M. Stark________________________
                    
Title: __VP &GC_____________________________

Schedule 13.5
MDCO Press Release

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

DRAFT, NOT FOR RELEASE:

The Medicines Company Settles Angiomax® (bIVALIRUDIN) Patent LitigationS with Teva
Parsippany, N.J., October __, 2011— 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 Applications (ANDAs) filed by Teva Parenteral Medicines, Inc. and its affiliate, Pliva Hrvatska d.o.o. (collectively “Teva”), for generic versions of Angiomax® (bivalirudin for injection).  The settlement includes a license by MDCO to Teva Pharmaceuticals USA, Inc. and its affiliates under which Teva may launch a generic bivalirudin product under one of its ANDAs in the U.S. on June 30, 2019.  In certain limited circumstances, MDCO’s license to Teva would become effective prior to June 30, 2019.
As part of the agreement, Teva admits that the two patents asserted in the lawsuits are valid and enforceable against, and would be infringed by, Teva's proposed generic bivalirudin products.  The patents at issue in the litigation are listed in the Orange Book and expire on July 27, 2028. 
MDCO also entered into an agreement with Teva under which Teva will supply bivalirudin active pharmaceutical ingredient (API) to MDCO.  This provides an additional source of API to support planned growth of product use.
“This result reflects our continued confidence in the strength of our patents, and we will continue to vigorously defend our intellectual property,” said Dr. Clive Meanwell, Chairman and CEO of The Medicines Company.   “We are delighted to partner with Teva who will provide us needed additional manufacturing capacity and a second source of high quality Angiomax® active ingredient which we can finish, fill and supply to our hospital customers for millions of patients.”
As required by law, MDCO and Teva will submit the agreements to the U.S. Federal Trade Commission and the U.S. Department of Justice.

Background on the litigation now settled.

On September 4, 2009, MDCO announced that it had received a Paragraph IV Certification Notice Letter from Teva notifying MDCO that Teva had submitted ANDAs to the Food and Drug Administration for approval to market generic versions of Angiomax®.  On October 8, 2009 and December 28, 2009, MDCO filed patent infringement lawsuits against the Teva defendants.  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, which expire on July 27, 2028. 

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

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, including the Company’s preliminary revenue results, 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 ability to develop its global operations and penetrate foreign markets, whether the Company's products 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, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, 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 August 2, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.MDCO EX 10.4 09.30.2011

Exhibit 10.4

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

SUPPLY AGREEMENT

(the "Agreement")

entered into on this 30th day of September, 2011

between

Plantex USA Inc.
A company incorporated under the laws of New Jersey with its principal place of business at
400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677

(“Plantex”)

and

The Medicines Company
A company incorporated under the laws of Delaware with registered office at8 Sylvan Way, Parsippany, NJ 07054

 (“Purchaser”)

1.INTERPRETATION AND DEFINITIONS    2
2.SALES AND PURCHASE OF API    4
3.ORDERS, QUANTITIES, LEAD TIME AND DELIVERY    5
4.PRICE AND PAYMENT    7
5.QUALITY INSPECTION OF PRODUCT    8
6.CONFIDENTIALITY    13
7.WARRANTIES    9
8.CLAIMS FOR PATENT INFRINGEMENT    10
9.INDEMNIFICATION    10
10.TERM    12
11.BREACH AND TERMINATION    12
12.GOVERNING LAW AND DISPUTE RESOLUTION    13
13.FORCE MAJEURE    14
14.GENERAL PROVISIONS    15
15.NOTICES    17

WHEREAS, Plantex is a manufacturer (through its Affiliates) of active pharmaceutical ingredients at Plantex’s Facility, as defined below, 

WHEREAS, Purchaser is a pharmaceutical company whose activities focus on research, development, production, licensing, manufacturing and marketing of pharmaceutical products; 

WHEREAS, Purchaser is the owner of New Drug Application No. 20-873 (the “NDA”), which was approved by the FDA for the manufacture and sale of a product containing the API, as defined below, as its sole active ingredient, which Purchaser sells under the tradename Angiomax® (“Angiomax”);

WHEREAS, Affiliates of Plantex, Teva Parenteral Medicines, Inc. and Pliva Hrvatskad.o.o., through Barr Laboratories, Inc. as its filing agent, submitted Abbreviated New Drug Applications to the FDA seeking approval to engage in the manufacture, use and sale of a generic Angiomax product;

WHEREAS, Purchaser sued certain Affiliates of Plantex for patent infringement related to such submissions to the FDA;

WHEREAS, Purchaser and certain Affiliates of Plantex have decided to settle such litigation and Purchaser and Teva Pharmaceutical Industries Limited, an Affiliate of Plantex, are entering into, on even date herewith, a Settlement Agreement  (the Settlement Agreement”) and License Agreement (“License Agreement”);

WHEREAS, Plantex wishes to supply the API to Purchaser on the terms and conditions set out below; and Purchaser wishes to acquire the API from Plantex on such terms and conditions.

THEREFORE, in consideration of the premises and of the mutual covenants and agreements set forth in this Agreement, and other good and valuable consideration the adequacy and sufficiency of which is acknowledged, the Parties, intending to be legally bound, agree as follows:

1.INTERPRETATION AND DEFINITIONS
		
	1.1.
	The preamble to this Agreement forms an integral part hereof.

		
	1.2.
	Clause headings in this Agreement are intended solely for convenience of reference and shall be given no effect in the interpretation of this Agreement.

		
	1.3.
	All appendices to this Agreement, if any, whether attached at the time of signature hereof or at any time thereafter, shall be construed as an integral part of this Agreement. In case of any inconsistency between the appendices and the body of the Agreement, the body of the Agreement shall take precedence and prevail over the appendices to the extent of any such inconsistency.  

		
	1.4.
	In this Agreement, the following expressions shall bear the meanings assigned to them below and cognate expressions shall bear corresponding meanings.

		
	1.4.1.
	“Affiliates”– with regard to either Party, any person, corporation, company, partnership, joint venture or other entity controlling, controlled by or under common control with such Party. For such purpose the term “control” means the holding of fifty percent (50%) or more of the common voting stock or ordinary shares in, or the right to appoint fifty percent (50%) or more of the directors of, or the right to share fifty percent (50%) or more of the profits of, the said corporation, company, partnership, joint venture or entity. For the purposes of this Agreement, Teva Pharmaceutical Industries Limited and any Affiliates of Teva Pharmaceutical Industries Limited, including, Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc., Pliva Hrvatska d.o.o., Pliva d.d., Barr Laboratories, Inc., Barr Pharmaceuticals, Inc., Barr Pharmaceuticals, LLC, and Plantex Ltd. shall be deemed Affiliates of Plantex. Wherever one or more Affiliates of Plantex are involved in or responsible for any of the activities and obligations ascribed to Plantex in this Agreement, the omission of specific reference to any such Affiliates in any such instances shall not relieve Plantex or such Affiliates from responsibility for such activities and obligations.

		
	1.4.2.
	“Alternative Material”–active pharmaceutical ingredient equivalent to the API, as defined below, which is manufactured by a third party holding a drug master file for such active material.

		
	1.4.3.
	“APl”–the active pharmaceutical ingredient bivalirudin.

		
	1.4.4.
	“Authorized Generic”– a generically labeled lyophilized bivalirudin drug product marketed by Purchaser or a third party authorized by Purchaser.

		
	1.4.5.
	“DMF”– the drug master file filed and maintained by Plantex and its Affiliates with the FDA relating to the manufacture of the API.

		
	1.4.6.
	“Effective Date”‐ the date at the head of this Agreement, provided that the Agreement has been duly executed by both Parties.

		
	1.4.7.
	“FDA”–the United States Food and Drug Administration and all agencies under its direct control or any successor organization.

		
	1.4.8.
	“Finished Product” - the finished form of pharmaceutical product to be formulated by Purchaser, using the API as the active ingredient.

		
	1.4.9.
	"cGMP" – current good manufacturing practices in accordance with the rules and regulations promulgated by the FDA.

		
	1.4.10.
	“Marketing Authorizations”– the required authorizations and approvals to be granted by the FDA or any other duly designated Regulatory Authority in the Territory for the marketing, use and sale or distribution of the Finished Product in the Territory.

		
	1.4.11.
	“Party”–Plantex or Purchaser as the context requires, and “Parties” collectively PLANTEX and Purchaser.

		
	1.4.12.
	“Plantex’s Facility” - a manufacturing facility identified in the DMF for purposes of manufacture of the API pursuant to this Agreement.

		
	1.4.13.
	“Quarter”– a three-month consecutive period with the first three month period commencing on the first of either January 1, April 1, July 1 or October 1 and each subsequent 3 month calendar period commencing on the day immediately following the last day of the then immediately preceding period.

		
	1.4.14.
	“Quality Agreement”– the API Quality Agreement between Purchaser and Plantex Ltd., of even date herewith, relating to the manufacture of the API.

		
	1.4.15.
	“Regulatory Authorities” - any and all governmental bodies and organizations, including, without limitation, the FDA, which regulate the manufacture, importation, distribution, use or sale of the API or Finished Product in the Territory.

		
	1.4.16.
	“Specifications”–the technical specifications of the API set out in Appendix A.

		
	1.4.17.
	“Territory”–the United States of America, and each of its territories, districts and possessions and the commonwealth of Puerto Rico, subject to Section 2.3.

		
	1.4.18.
	“Term”– as defined in Section 9.

2.    SALES AND PURCHASE OF API
		
	2.1.
	During the Term, Plantex hereby agrees to manufacture, sell and supply to Purchaser solely for the formulation by or for Purchaser of the Finished Product and the licensing, marketing and sale thereof solely in the Territory, and Purchaser hereby agrees to purchase the API produced by Plantex on the terms and conditions set out in this Agreement for the said sole purpose. 

		
	2.2.
	In the event that Purchaser desires to transfer the Marketing Authorizations to one or more third parties, Plantex shall provide such third parties with a “Letter of Access” to the DMF; provided that Plantex’ agreement to do so may be conditioned upon the agreement of the Purchaser to assign this Agreement to such third party.

		
	2.3.
	In the event that Purchaser requests to expand the Territory covered in this Supply Agreement, Plantex will use commercially reasonable efforts to support such request.

3.    ORDERS, QUANTITIES, LEAD TIME AND DELIVERY
		
	3.1.
	Commercial Supply. 

		
	3.1.1
	Purchaser shall issue Purchase Orders for a minimum of [**] kgs in [**], a minimum of [**] kgs in [**], and a minimum of [**] kgs in [**] of the API from Plantex. These requirements shall remain fixed regardless of whether or not a generic form of Angiomax is launched in the market in the Territory.

		
	3.1.2
	Beginning in [**] and for the duration of the Term thereafter, Purchaser shall issue Purchase Orders for a minimum [**] kgs of the API per calendar year from Plantex, subject to Section 3.1.2.1 below.

		
	3.1.2.1
	If a generic form of Angiomax is launched in the market in the Territory, then from and after January 1, 2013  Purchaser shall have the right to terminate its agreement to purchase API hereunder with immediate effect, and the Parties will meet in good faith to discuss terms for Purchaser’s possible continued purchase of API (as to both quantities and, as provided in Section 4.3, the price of the API). 

		
	3.2.
	Purchaser and its Affiliates shall use the API only for the manufacture of Finished Products for sale or use in the Territory. Purchaser and its Affiliates are prohibited from reselling or otherwise transferring all or any portion of API that is not used in the manufacture of Finished Products for sale or use in the Territory to any other person or entity, either directly or indirectly, including through its contract manufacturers or other third parties, without written permission of Plantex.

		
	3.3.
	Forecasts. On or before October 31, 2011, and thereafter by the 15th day of each October and April during the Term, Purchaser shall provide Plantex with a good faith, twenty-four (24) month rolling forecast of its API requirements by quarter (“Forecast”) commencing from the quarter following the quarter in which the Forecast is provided (i.e. January or July, as the case may be)..The first [**] months of each Forecast, shall be considered binding (the "Binding Forecasted Period") for the API indicated for those months. The quantities set forth in each Binding Forecasted Period for each Forecast shall not be in an amount less than eighty percent (80%) or greater than one hundred and twenty percent (120%) of the quantities set forth in the second [**] month period of the immediately preceding Forecast. 

		
	3.4.
	Orders. Concurrent with Purchaser supplying Plantex with the Forecasts, the Purchaser shall place firm purchase orders for the quantities not less than the quantities specified in the Binding Forecasted Period of such Forecasts ("Purchase Orders"). Purchase Orders shall reference this Agreement and specify the API, quantities, prices, delivery destination and required delivery dates, which shall be in accordance with the applicable Forecast. In the event Purchaser provides Purchase Orders subsequent to the date of submitting the Forecast, the required delivery dates in such Purchase Orders shall be at least ninety (90) days from the date of placing the Purchase Order, except as otherwise specifically and expressly agreed to in writing by Plantex ("Lead Time"). Purchase orders shall be subject to confirmation and acceptance by Plantex, at its sole discretion. Purchaser has placed a Purchase Order applicable to its 2011 requirements, a copy of which is attached as Appendix B. 

		
	3.5.
	Plantex shall use its commercially reasonable efforts to confirm and accept Purchase Orders and supply the quantities set forth in the Purchase Orders within [**] business days of the designated delivery dates (provided that such Purchase Orders comply with the applicable Lead Time). Plantex shall promptly advise Purchaser if, for any reason, including without limitation force majeure as defined in Section 13 hereof, it believes that it will be unable to supply Purchaser (a) with the requisite quantities of API specified in a Purchase Order, or (b) by the date of delivery specified in a Purchase Order.

In the event that Plantex delays the delivery of the API specified in a Purchase Order, or part thereof, by more than one (1) month beyond the delivery date set forth in such Purchase Order or fails to delivery API which conforms to the warranties set forth in Section 6.1, then for so long as Plantex’s inability persists, Purchaser shall as its sole and exclusive remedy have the right to purchase Alternative Material to the extent necessary to cover the shortfall in Plantex’s supply of API, only until such time as Plantex notifies Purchaser in writing that it is able to resume the supply of API, and Purchaser’s minimum purchase obligations hereunder shall be reduced by the amount of Alternative Material so purchased by Purchaser.  Purchaser's right pursuant to this Section shall not apply to the quantities specified in the Purchase Order which exceed one hundred and twenty per cent (120%) of the quantities set forth in the Binding Forecasted Period.
		
	3.6.
	Delivery. The API shall be delivered EX WORKS (per Incoterms 2010) at Plantex’ Facility.  

		
	3.7.
	Risk of Loss and Title.  Risk of loss and/or damage to the API ordered by Purchaser, and title therein, will pass to Purchaser upon delivery of the API.

		
	3.8.
	Quality.  At the time of the delivery, the API shall conform to the Specifications. Certain of the Parties’ responsibilities with respect to the API are set forth in the Quality Agreement, which is incorporated herein as if set forth at length. 

		
	3.9.
	Packaging. The API shall be delivered to Purchaser as specified in the DMF and Specifications. 

4.    PRICE AND PAYMENT
		
	4.1.
	The price for the minimum purchase quantities of API provided in Section 3.1 will be fixed at $[**] per gram for [**] and [**] and $[**] per gram for [**].

		
	4.2.
	Beginning with [**] and for the duration of the Term thereafter, so long as Purchaser purchases [**] kgs or more per year of the API, the price shall be $[**] per gram, but if Purchaser purchases less than [**]kgs per year of the API, the price shall be $[**] per gram. 

		
	4.3.
	Notwithstanding the above, pricing for [**] and for the duration of the Term shall be subject to Section 3.1.2.1 and Sections 4.3.1 and 4.3.2 below:

		
	4.3.1.
	If a generic form of Angiomax is launched in the market in the Territory, the Parties will meet to discuss, in accordance with Section 3.1.2.1, Purchaser’s possible continued purchase of API and the pricing for [**] and for the duration of the Term.

		
	4.3.2.
	Plantex shall be entitled to modify the price of the API beginning with calendar year [**] and for each calendar year in the Term thereafter due to a documented increase of more than [**]% of the manufacturing cost of the API which is a result of increases of the purchase price index, cost of goods, labor and overhead charges and any changes in the market which have affected the price; provided that in no event will Plantex be able to increase the price for the API more than [**]% in any calendar year.

		
	4.4.
	Plantex shall issue and dispatch invoices with each delivery (or partial delivery) of the API delivered by it together with such certificates and documentation as may be required for the purposes of customs clearance of the API including without limitation a signed certificate of analysis.  

		
	4.5.
	All invoices shall be paid in US Dollars within [**] days from the date of the applicable invoice. Prices do not include any sales tax, which shall be payable by Purchaser if applicable. Payments shall be made by wire transfer to Plantex’s designated bank account as notified to Purchaser by Plantex. Amounts not paid when due shall accrue interest calculated at the rate of four percent (4%) plus the U.S. prime rate (but in no event greater than the maximum rate permitted by law) in effect on the date that the payment should have been made, as published in The Wall Street Journal, Eastern U.S. Edition, calculated on a daily basis. No deductions of any kind from any payment becoming due to Plantex may be made in the absence of an official credit memorandum from Plantex authorizing the deduction.

5.    QUALITY INSPECTION OF PRODUCT and REGULATORY INSPECTIONS
		
	5.1.
	Purchaser shall inspect each shipment upon its receipt of API for all defects and conformance with the Specifications. Any API not rejected within [**] days of delivery to Purchaser shall be deemed to have been accepted by Purchaser. Any latent defects in API not detectable by means of the inspection specified in this Section shall be notified by Purchaser to Plantex promptly after discovery thereof but by not later than the date of expiration of the shelf life for the relevant API.

		
	5.2.
	In the event that Purchaser alleges that any API delivered to it does not meet the Specifications, Purchaser shall notify Plantex setting out full details of the alleged defect. Purchaser shall, on request by Plantex, provide Plantex with a sample of the allegedly non-conforming API, which shall be examined by Plantex as soon as reasonably practicable but in any event within [**] days of receipt thereof by Plantex. 

		
	5.3.
	In the event that Plantex is in agreement with the contentions as to non-conformance raised by Purchaser:

		
	5.3.1.
	Plantex shall at its sole discretion either: (1) credit Purchaser the amount paid or invoiced for such API or (2) dispatch to Purchaser replacement API as soon as is reasonably practicable but in any event within [**] days following Purchaser's notification of non-conformance, all costs in respect of which shall be borne by Plantex; 

		
	5.3.2.
	Purchaser shall, if so requested by Plantex, return to Plantex at Plantex’s expense, any API that is nonconforming or otherwise dispose of such API, at Plantex’s expense, and in accordance with instructions provided by Plantex. If Plantex does not so direct, within [**] business days following Purchaser's notification of non-conformity, Purchaser may dispose of such API as Purchaser may deem reasonably appropriate, provided that any such disposal complies with environmentally acceptable standards, and Plantex shall bear the costs of such disposal.

		
	5.3.3.
	Plantex’s liability in any such case remains strictly limited only to replacement of or credit for the API.

		
	5.4.
	In the event that Plantex is not in agreement with the contentions as to non-conformance raised by Purchaser, representative samples of the allegedly non-conforming API, together with details of Purchaser’s contentions as to non-conformance, shall be submitted to a mutually acceptable independent laboratory which shall examine such samples in a method specified by the Parties as part of a mutually agreed testing procedure. The Parties shall endeavor to procure that within thirty (30) days, the said laboratory issues its finding as to whether the API conforms to the specifications.  The results of the said laboratory shall be final and binding on the Parties, and not subject to appeal or review, and the costs associated with such submission and determination shall be borne by the Party against which the laboratory decides. Notwithstanding the above, if it is determined that the non-

compliance is due to damage to the API caused by Purchaser or its agents, Plantex will have no liability to Purchaser with respect to such non-compliance and the cost of any testing and evaluation by the independent laboratory will be borne solely by Purchaser.
		
	5.5.
	Plantex shall, upon receiving a written request from Purchaser, supply technical information on the API and methods of manufacture to the extent that such information is necessary to enable Purchaser to fulfill its obligations under this Agreement, including compliance with any statutory or Regulatory Authority located within the Territory.  Upon Plantex receiving at least [**] days advance notice in writing from Purchaser, and not more than once every two (2) years, Plantex shall permit Purchaser, by prior arrangement with and at a time convenient to Plantex, to inspect those areas of Plantex’s Facilities where API is manufactured for Purchaser, and audit its records (in the presence of a representative of Plantex) relating to the manufacturing and quality control of the API to the extent reasonably necessary to enable Purchaser to verify compliance with any regulatory requirements to which Purchaser is subject and which are applicable to the manufacture, importation, and marketing of the API. Purchaser acknowledges that all information supplied by Plantex or acquired by Purchaser by virtue of the provisions of this clause shall be strictly confidential and subject to the provisions of Section11 hereof.

		
	5.6.
	Purchaser undertakes to be solely responsible for any recall of the Finished Products at any time, and to accept any liability arising in respect of the Finished Products.

		
	5.7.
	In the event of a conflict between the terms set forth in this Section 5 and the terms provided in the Quality Agreement, the terms set forth in the Quality Agreement shall control.

6.    REPRESENTATIONS ANDWARRANTIES
		
	6.1.
	PLANTEX, on behalf of itself and its Affiliates, hereby represents, warrants and covenants to the Purchaser that:

		
	6.1.1.
	the API shall conform to the Specifications;

		
	6.1.2.
	the API to be supplied hereunder shall be manufactured, stored and packaged for shipment in accordance with cGMP at a Plantex Facility;

		
	6.1.3.
	all API supplied hereunder shall be free and clear of all security interests, liens, or other encumbrances of any kind or character; and

		
	6.1.4.
	all API supplied hereunder shall be accompanied by all documentation necessary for the use in the Territory under the applicable Marketing Authorizations.

		
	6.2.
	Expect as set forth in Section 3.5 and as may be subject to indemnification under Section 8.2, the replacement of non conforming API shall be 

Purchaser’s sole remedy for claims that any shipment of API failed to comply with the warranties set forth herein.
		
	6.3.
	THE WARRANTIES SET OUT ABOVE ARE THE ONLY WARRANTIES GIVEN BY PLANTEX AND ARE MADE IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED. ANY EXPRESS OR IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY APPLICABLE TO THE APIARE HEREBY EXCLUDED.

		
	6.4.
	Plantex hereby represents and warrants that it has the authority to bind all of its Affiliates to the terms of this Agreement.

		
	6.5.
	Plantex makes no warranty as to the patentability of any of the API or as to immunity from any action for infringement of third party intellectual property rights including but not limited to registered patents or patent applications arising out of the regulatory approvals, importation into the territory, distribution, marketing, sale and/or use of the API.

		
	6.6.
	If any limitation of liability shall be deemed invalid by any applicable law, then each Party’s liability shall be within the limitation permitted by that law.

7.    CLAIMS FOR PATENT INFRINGEMENT
		
	7.1.
	In the event a claim for patent infringement is brought against Purchaser on account of Plantex’s supply of API to Purchaser and use thereof in the manufacture, use, marketing or sale of the Finished Product, or Purchaser has reason to believe that any such claim might be brought against it, Purchaser shall inform Plantex as soon as possible of the particulars of the claim.  Plantex shall cooperate with Purchaser in the defense of any such claim.

		
	7.2.
	The provisions of this Section 7 shall survive the expiration or termination of this Agreement for any reason.

8.    INDEMNIFICATION
		
	8.1.
	Subject to and without derogating from the limitations of Purchaser’s liabilities as set forth in this Agreement, the Purchaser shall defend, indemnify and hold Plantex, its Affiliates and each of their respective officers, directors, agents, employees and shareholders (collectively, “Plantex Indemnitees”) harmless from and against any and all claims, damages, loss and expense suffered by Plantex arising from claims by third parties in connection with or resulting from any of the following: (a) the storage, handling, manufacture, license, use, marketing, advertising, promotion, distribution or sale of the Finished Product by Purchaser or its Affiliates, sublicensees, distributors or agents or the conduct of business by Purchaser or its Affiliates, sublicensees, distributors or agents in the Territory, including, but not limited to, liabilities for product liability and returned goods; and (b) the breach of any representation, warranty or covenant by Purchaser under this Agreement; and (c) gross negligence or willful misconduct by the Purchaser or its Affiliates and each of their respective officers, directors, agents, employees in connection with the implementation of this Agreement; and (d) violation of any applicable law by Purchaser or any of its Affiliates and each of their respective officers, directors, agents, employees; and (e)  any bodily injury, illness or death of any person caused or alleged to be caused by the use, distribution or sale of the Finished Product; and (f)  any actual or alleged infringement (whether direct, contributory, or induced) or violation of any patent, trade secret or proprietary rights of any third party arising out of Purchaser’s or its Affiliates and each of their respective officers, directors, agents and employees manufacturing, importing, registering, storing, distributing or selling the Finished Product.

		
	8.2.
	Subject to and without derogating from the limitations of Plantex' liabilities as set forth in this Agreement, Plantex shall defend, indemnify and hold the Purchaser, its Affiliates and each of their respective officers, directors, agents, employees and shareholders (collectively, “Purchaser Indemnitees”) harmless from and against any and all damages, loss or expense suffered by Purchaser arising from claims by third parties in connection with or resulting from any of the following: (a) the breach of any representation, warranty or covenant by Plantex under this Agreement; and (b) gross negligence or willful misconduct by Plantex or its Affiliates and each of their respective officers, directors, agents, employees in connection with the implementation of this Agreement; and (c) violation of any applicable law by Plantex or any of its Affiliates and each of their respective officers, directors, agents, employees. Not withstanding the above section 8.2 Plantex’s liability in the event of a product liability claim shall be limited to the aggregate dollar value of the Purchaser’s minimum purchase requirements, as set forth in this agreement, actually ordered by Purchaser for the twelve months immediately proceeding the time the claim is made.

		
	8.3.
	Each of Purchaser and Plantex (“the Indemnitee”) undertakes in favor of the other of them (“the Indemnifier”):

		
	8.3.1.
	 to promptly notify the Indemnifier of the bringing or threat of any claim or legal proceeding against the Indemnitee and for which the Indemnitee is indemnified by the Indemnifier;

		
	8.3.2.
	to abide by such lawful and reasonable instructions as the Indemnifier may issue concerning the conduct of such claim, or the defense of such proceeding and at the Indemnifiers request to relinquish control of such claim or defense to the Indemnifier.

		
	8.3.3.
	not to make, without the Indemnifier’s express written authorization, any admission of liability to a claimant or plaintiff or his or her legal representative or insurer in respect of such claim or such proceedings or threatened proceedings and,

		
	8.3.4.
	not to make, without the Indemnifier’s express written authorization, any settlement or compromise of such claim or threatened claim or such proceedings or threatened proceedings.

		
	8.4.
	Neither party shall be liable to the other party (whether under contract or tort, including negligence) or otherwise, or to any third party for any indirect, special or consequential damages, including without limitation, for any loss or damage to business earnings, anticipated sales, anticipated or lost profits or goodwill suffered by the other party and/or related with and/or connected to the performance of this Agreement, even if such party is advised or should have known of the possibility of such damages. 

		
	8.5.
	The provisions of this Section 8 shall survive the expiration or termination of this Agreement for any reason.

9.    TERM

This Agreement shall commence on the Effective Date and, unless earlier terminated as provided below, shall remain in full force and effect until December 31, 2015(the “Initial Term”).  Thereafter, the Agreement will automatically renew for up to two successive three (3) year periods (each such period, a “Renewal Term”), unless terminated by Purchaser on at least six (6) months written notice or by Plantex on at least twenty four (24) months written notice prior to the expiration of the Initial Term or either Renewal Term.  The Initial Term together with the Renewal Terms shall be the Term.

		
	10.
	BREACH AND TERMINATION

		
	10.1.
	Either of Plantex or Purchaser may terminate this Agreement prior to its expiration at any time by sending a written notification to the other Party in the event that:

		
	10.1.1.
	the other Party fails materially to perform any obligation hereunder or the other Party materially violates any representation or warranty made herein and such failure or violation continues unremedied for a period of thirty (30) days following written notice by the terminating Party; or 

		
	10.1.2.
	the other party admits to being or is declared insolvent or voluntary or involuntary proceedings are instituted by or against it in bankruptcy, or receivership, or for a winding-up or for the dissolution or re-organization of its assets.

		
	10.2.
	Purchaser shall have the right to terminate this Agreement with immediate effect upon the breach of the Settlement Agreement or section 3.3 or 3.10.2 of the License Agreement by an Affiliate of Plantex and as otherwise set forth in the Settlement Agreement.  In the event this Agreement is terminated pursuant to this Section 10.2, all of Purchaser’s obligations herein, including the minimum purchase requirements set forth in Section 3.1 and any requirement to order or purchase API (including any outstanding orders or already manufactured API) shall immediately terminate.

		
	10.3.
	Purchaser shall have the right to terminate this Agreement 

as provided in Section 3.1.2.1.
		
	10.4.
	Except with respect to a termination pursuant to Section 10.2, or unless agreed otherwise between the Parties, Purchaser will be required to purchase, and Plantex shall be required to supply the API in respect of which orders have been placed prior to expiration or termination of the Agreement, but not yet supplied on the date of termination.

		
	10.5.
	Upon termination of this Agreement, all rights and obligations will cease to exist except for (a) the payment of unpaid invoices due, (b) the confidentiality and Indemnification rights and obligations of the Parties, which shall survive the termination of this Agreement for a period of ten (10) years, and (c) any other term or condition that by its term survives termination. Clauses referring to governing law and jurisdiction shall survive the termination of this Agreement.

11.    CONFIDENTIALITY
		
	11.1.
	In carrying out the terms of this Agreement and/or the Quality Agreement it may be necessary, from time to time, for a Party to disclose to the other Party certain information which is considered by the disclosing Party to be proprietary and of confidential nature (the “Confidential Information”).  Confidential Information shall include but shall not be limited to, any and all information, know-how and data, technical or non-technical, concerning any finished drug product or active pharmaceutical ingredient, its Manufacture, marketing and sale, plans, processes, compositions, formulations, specifications, samples, systems, techniques, analyses, production and quality control data, testing data, marketing and financial data, and such other information or data relating to any finished drug product or active pharmaceutical ingredient. 

		
	11.2.
	The recipient of any Confidential Information shall not use it for any purpose other than for the purposes of fulfilling its obligations under this Agreement. The recipient shall disclose Confidential Information only to those of its officers, directors, employees advisors and Affiliates (and such Affiliates' officers, directors, employees and advisors) requiring knowledge thereof in connection with their duties directly related to the implementation of this Agreement, and said officers, directors, employees, advisors and Affiliates (and such Affiliates' officers, directors, employees and advisors) shall hold the information in confidence pursuant to this Agreement. The recipient agrees that it will exercise the same degree of care and protection to preserve the proprietary and confidential nature of the Confidential Information disclosed by the disclosing Party, as recipient would exercise to preserve its own proprietary and confidential information, and in any case no less than a reasonable degree of care.  Recipient agrees that it will, upon request of the disclosing party, immediately return all documents and any copies thereof containing Confidential Information belonging to, or disclosed by the disclosing party.

		
	11.3.
	Confidential Information shall not be deemed to include:

		
	11.3.1.
	Information in the public domain or which was known to or in the 

possession of the recipient prior to the disclosure;
		
	11.3.2.
	Information which is independently developed by recipient or its Affiliates and which can be evidenced by way of documentation.

		
	11.3.3.
	Information that becomes available to recipient on a non-confidential basis, whether directly or indirectly, from a source other than a Party, which source, to the best of recipient’s knowledge, did not acquire this information on a confidential basis.

		
	11.3.4.
	Information which recipient is required to disclose pursuant to a valid order of a court or other governmental body or otherwise required by law upon prior notice to the other Party that such Confidential Information has been required.

		
	11.4.
	Upon expiration or earlier termination of this Agreement, the recipient of any Confidential Information shall, as the disclosing Party may direct in writing, either destroy or return to the disclosing Party all Confidential Information disclosed together with all copies thereof, provided, however, the recipient may retain one archival copy thereof for the purpose of determining any continuing obligations of confidentiality.

		
	11.5.
	The provisions relating to confidentiality in this Section shall remain in effect following termination of this Agreement for a period of ten (10) years.

		
	11.6.
	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 approval of, both Parties. Each Party responding to a request for such approval shall respond to the requesting Party in writing within five (5) days of such request or within such shorter period as either Party may require in order to comply with applicable law.

12.    GOVERNING LAW AND DISPUTE RESOLUTION

This Agreement will be governed by and construed in accordance with the laws of the State of New York, without regard for the conflicts of law principles thereof.  The Parties agree that any controversies arising under this Agreement shall be presented before the State Courts for the State of New York.  Plantex and Purchaser hereby submit themselves to the personal jurisdiction of such courts in connection with any such proceedings.

13.    FORCE MAJEURE
		
	13.1.
	Except for the obligation of a Party to make payments to the other pursuant to this Agreement (that will not be deferred or extended for any reason), neither Party shall be liable for any non-performance or delay in 

performance due to any cause beyond its reasonable control (insofar as they are beyond such control) including, but without derogating from the generality of the foregoing expression, strikes, lock-outs, labor disputes, acts of God, war, riot, civil commotion, malicious damage, act of terrorism, embargo, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant, fire, flood, or storm. 
		
	13.2.
	In the event of either Party being so hindered or prevented, such Party shall give notice of suspension as soon as reasonably possible to the other Party stating the date and extent of such suspension and the cause thereof. 

		
	13.3.
	Any Party whose obligations have been suspended as aforesaid shall nevertheless make every endeavor to carry out its obligations under this Agreement, even if in a partial or compromised manner, and shall resume the performance of such obligations as soon as commercially reasonable after the removal of the cause and shall so notify the other Party.

		
	13.4.
	In the event that such cause continues for more than six (6) consecutive months either Party may terminate this Agreement on fourteen (14) days written notice to the other Party, and in such event neither Party shall have any claim against the other arising from such termination.

14.    GENERAL PROVISIONS
		
	14.1.
	Non-assignability: This Agreement may not be assigned in whole or in part by either of the parties hereto without the prior written consent of the non assigning party hereto. Such consent may be conditioned upon the agreement of the assigning Party to remain primarily liable for performance of all obligations of the assignee. Both Parties shall be entitled to assign, delegate, and/or subcontract its rights and obligation under this Agreement, in whole or in part, to one or more of its Affiliates on prior written notice to the other Party. Purchaser shall be entitled to assign, delegate, and/or subcontract its rights and obligation under this Agreement, in whole, to a third party that acquires ownership of the NDA. The foregoing notwithstanding, either Party shall be entitled to assign this Agreement to an acquirer of all or substantially all of its capital stock or assets, whether through purchase, merger, consolidation or otherwise.

		
	14.2.
	Power and representation: Each Party has full power and authority to execute, deliver and perform this Agreement and to incur the obligations provided herein under their respective laws.  The entering into of this Agreement has been duly authorized by all proper and necessary action, corporate or otherwise, of each of the Parties.  No consent or approval of shareholders or of any other person, other than those which have been obtained by each Party and remain in effect, is required as a condition to the validity, implementation or enforceability of this Agreement.

		
	14.3.
	No intellectual property rights: Nothing in this Agreement shall be deemed to give either Party any right, title, license or other interest in or to any trade name, trade mark, patent, copyright, design, packaging, set-up or other intellectual property right of the other of them or any of its Affiliates retaining 

such right at the date of signature of this Agreement or at any time thereafter.
		
	14.4.
	UN Convention: To the extent that it may otherwise be applicable, the Parties hereby expressly agree to exclude from the operation of this Agreement, the United Nations Convention on Contracts for the International Sale of Goods, concluded at Vienna, on 11 April 1980, as amended and as may be amended further from time to time.

		
	14.5.
	Entire Agreement: This Agreement constitutes the entire understanding between the Parties with regard to the subject matter hereof, and supersedes all prior written and oral understandings and agreements. This Agreement may be amended only by a written instrument duly signed by the Parties.

		
	14.6.
	Insurance: 

Both Parties agree to maintain in full force at their individual expense the following minimum required insurance coverage: (i) comprehensive General Liability insurance coverage, including broad form contractual liability coverage, affording a limit of $5,000,000 Bodily Injury/Property Damage Liability per occurrence and in the aggregate; and (ii) product liability insurance with minimum limits of $5,000,000 per occurrence and $10,000,000 annual aggregate. These minimum required insurance coverages shall be kept in full force at all times during the entire period of the Agreement and any renewals thereof.   If any required insurance is written on a claims made basis, the policy holder/named insured shall ensure continuity of coverage for any claims arising after the policy expiry date for a period of 24 months. Both Parties agree to provide written notice to the other upon becoming aware of any material change, non-renewal or cancellation of insurance. Failure to maintain minimum required insurance may be deemed a breach of the Agreement. Upon execution of the Agreement and upon request thereafter, both Parties will provide to the other evidence of required insurance, causing each other to be shown as “certificate holder”, except for Purchaser’s product liability insurance where Supplier shall be listed as “additional insured”.  
The insurance policies shall contain an explicit clause declaring that the policy is primary, preliminary and non contributory to any other insurance maintained by the other party, and the insurance company shall waive any claim or demand as to participation in any such other insurance policy under which the other company is covered, and will not participate as a co-insurer in any cases of loss or damage.
		
	14.7.
	Conflict with other documents: In the event of any conflict between the terms and conditions of this Agreement and the terms and conditions set forth in any standard or other purchase order documentation or any document evidencing acceptance thereof or setting out terms of delivery and/or payment, the terms and conditions of this Agreement shall prevail unless such other document records expressly state that it prevails over this Agreement and is signed by duly authorized representatives of both Parties.

		
	14.8.
	No Agency: Plantex and Purchaser will act at all times as independent 

parties. This Agreement does not make Purchaser an agent or legal representative of Plantex for any purpose whatsoever. Purchaser is not granted any right or authority to assume or to create any obligation or responsibility, express or implied, on behalf of or in the name of Plantex, with regard to any manner or thing whatsoever, unless otherwise specifically agreed upon in writing.
		
	14.9.
	Either Parties’ failure to terminate or seek redress for a breach of, or to insist upon strict performance of any term, covenant, condition or provision contained in this Agreement will not prevent a similar subsequent act from constituting a breach of this Agreement.

		
	14.10.
	If any portion of this Agreement is determined to be illegal or otherwise unenforceable by agreement of the Parties, by an arbitrator, by a court of competent jurisdiction or by an administrative agency of competent jurisdiction, that Section, to the extent permitted by law, shall be treated as deleted from this Agreement and the remaining portions of this Agreement will continue to be in full force and effect according to the terms hereof.

		
	14.11.
	This Agreement may be executed in one or more counterparts, each of which shall constitute an original and all of which, when taken together, shall constitute one agreement.

		
	14.12.
	It is hereby acknowledged that the manufacturer of the API(provided such manufacturer is an Affiliate of Plantex) is intended to be a third party beneficiary hereunder such that all representations and covenants of Purchaser and its Affiliates contained in this Agreement shall also inure to the benefit of such manufacturer of API.

15.    NOTICES

Any payment’s notice, or other written communication required or permitted to be made or given hereunder may be made or given by either Party by facsimile or other electronic means such as e-mail; by first‐class mail, postage prepaid; or by courier to the mailing address or facsimile numbers set as below:

		
	If to Plantex:
	Plantex USA Inc.        

400 Chestnut Ridge Rd.
Woodcliff Lake, New Jersey 07677
Attention: President
Fax Number:    201-343-3833

with a copy to:    Plantex USA Inc.        
400 Chestnut Ridge Rd.
Woodcliff Lake, New Jersey 07677
Attention: General Counsel
Fax Number: 215-293-6499

If to Purchaser:        The Medicines Company
8 Sylvan Way

Parsippany, NJ  07054
Attention:  Chief Executive Officer
Fax Number:  

With a copy to:    The Medicines Company
8 Sylvan Way
Parsippany, NJ  07054
Attention:  General Counsel
Fax Number:  862 207 6062

or to such other addresses or facsimile numbers as a Party shall designate by notice, similarly given, to the other Party. Notices or written communications shall be deemed to have been sufficiently made or given: (i) if mailed, fourteen (14) days after being dispatched by mail, postage prepaid; (ii) if by air courier, seven days after delivery to the air courier company; or (iii) if by facsimile or other electronic means with confirmed transmission, within five (5) days of transmission. An additional copy of all notices issued by Purchaser relating to breach, termination or renewal of this Agreement shall be sent by Purchaser, to Plantex’s Legal Department, facsimile no. (201) 307-6909.

IN WITNESS WHEREOF, the undersigned authorized representatives of the respective Parties hereto have entered into and executed this Agreement as of the date set forth above.

	
		
	PLANTEXUSA Inc.
	The Medicines Company

	

signature:     /s/George Svokos__________________

name:          George Svokos

title: President
	

signature:     _/s/ Glenn Sblendorio______________

name:           _Glenn Sblendorio________________

title:EVP & CFO_______________________

	

signature:     /s/ Henit Lapid Ben Ari______________

name:         Henit Lapid Ben Ari

title:  Director of Sales and Marketing
	 

	

Date:   ____Sept. 29________, 2011
	

Date:   ____Sept. 30________, 2011

Appendix A

Specifications

	
	
	Tests and Limits

	1.       Characters

1.1Appearance
           [**]
2.         Identification

[**]
3          Tests

[**]

	

	

[**]
8.0Assay

[**]

Appendix B
Purchase Order for 2011 Requirements

	
					
	PO  000924-A 
(Revised)
	 
	 
	September 15, 2011

	 
	 
	 

	Vendor
	 
	The Medicines Company

	Plantex
400 Chestnut Ridge Road
Woodcliff Lake, NJ 07677
	 
	Accounts Payable
8 Sylvan Way
Parsippany, NJ 07054
United States

	 
	 
	 
	Ship To
	 

	 
	 
	 
	The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054

	Product
	Description
	Quantity
	Unit Price
	Total Price

	API Bivalirudin
	Purchase of API 
(bivalirudin)
	[**] 
grams
	$    [**]/gram
	$    [**]

	 
	 
	 
	Tax
	$0

	 
	 
	 
	Total
	$    [**]

	 
	 
	 
	 
	 

	Coding
	 
	 
	 
	 

	Cost Center
	Account
	Sub-Account
	Project

	[**]
	[**]
	0
	0

	 
	 
	 
	 
	 

	Special Terms
	 
	 
	 
	 

	•Firm order subject to signing of Settlement Agreement, License Agreement, and API Supply Agreement (collectively, the “Agreements”) on or before September 30, 2011.  Purchase Order will cancel if the Agreements are not signed on or before September 30, 2011.
•Availability of up to [**] grams on or before [**].  Balance of purchase order available on or before [**].
•The terms of the delivery of the quantities specified in section 2 of the terms in this Purchase Order are in accord with the terms of the Supply Agreement.
•Invoicing of the of the quantities specified in section 2 of the terms in this Purchase Order are in accord with the terms of the Supply Agreement
•MDCO shall take title and risk of loss of the product upon invoicing by Teva.
•MDCO requests that the product be stored under GMP conditions at one of Teva’s facilities until picked up by MDCO.
•MDCO will pick up the all product under this Purchase Order upon its request but in any event no later than [**].

	
		
	All invoices in reference to this purchase order should be mailed to the address specified above, or emailed to ap@themedco.com. Please include the following information on all invoices:

	 
	PO Number
        Care of: Accounts Payable
        Cost Center – If Specified in the PO
        Account – If Specified in the PO
        Sub-Account – If Specified in the PO
        Project Code – If specified on the PO

	
		
	    
Plantex
	/s/ Glenn Sblendorio    
The Medicines Company

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