DISTRIBUTION AGREEMENT

Exhibit 10.2

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

EXECUTION COPY

DISTRIBUTION AGREEMENT

This Agreement is made effective as of 1 ^st July 2007 (the “ Effective Date ”) by and between THE MEDICINES COMPANY, a Delaware corporation having offices at 8 Campus Drive, Parsippany, New Jersey  07054 (“ TMC ”), NYCOMED DANMARK ApS, P.O. Box 88, Langebjerg 1 DK-4000 Roskilde, Denmark, a company duly organized and existing under the laws of the Kingdom of Denmark (“ Nycomed ”), and NYCOMED HOLDING ApS,  P.O. Box 88, Langebjerg 1 DK-4000 Roskilde, Denmark, a company duly organized and existing under the laws of the Kingdom of Denmark (“ Nycomed Parent ”).

TMC and Nycomed shall be referred to individually as a “ Party ” and collectively as the “ Parties ”.

WITNESSETH:

Whereas, TMC is in the business of developing, manufacturing and marketing pharmaceutical products;

Whereas, Nycomed and TMC were parties to that Sales, Marketing and Distribution Agreement, dated 25 ^th March, 2002, as amended May 28 ^th , 2003 (the “ Former Distribution Agreement ), pursuant to which Nycomed was responsible for distribution, marketing, promotional and certain other services with respect to the Product (as defined herein) in the Territory (for purposes of these Recitals, as defined in the Former Distribution Agreement);

Whereas, pursuant to that Termination and Transition Agreement between the Parties and Nycomed Parent, dated the Effective Date (the “ Transition Agreement ”), the Parties and Nycomed Parent agreed, among other things, to terminate the Former Distribution Agreement and to enter this Agreement, as well as a Services Agreement, dated the date hereof (the “ Services Agreement ”), in order to continue certain activities of Nycomed under the Former Distribution Agreement without interruption;

Whereas, Nycomed is engaged in, among other things, the distribution of pharmaceutical products and has represented to TMC that it has the facilities, personnel, and technical expertise to distribute the Product in all countries of the Territory (as defined herein);

Whereas, TMC desires to appoint Nycomed as TMC’s exclusive distributor in the territory outlined in Exhibit A (the “ Territory ”) for the Product, and to sell the Product to Nycomed on the terms and subject to the conditions described in this Agreement and the Transition Agreement;

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Whereas, Nycomed desires to accept such appointment as an exclusive distributor of the Product in the Territory and to distribute the Product in the Territory, and to purchase the Product from TMC on the terms and subject to the conditions described in this Agreement;

Whereas, Nycomed’s role as a distributor under this Agreement shall include the following activities with respect to the Product:  importation, warehousing, logistical/handling, transportation, packaging and labeling, QA and QC (including release analysis), follow-up stability studies, order entry activities, booking of sales, billing and collection, product recall (as provided herein) and any other activities performed under the Former Distribution Agreement and Quality Agreements and not considered a “Service” under the Services Agreement; and

NOW THEREFORE, in consideration of the mutual agreements set forth herein, TMC and Nycomed hereby agree as follows:

1.              DEFINITIONS

All capitalized terms used in this Agreement not otherwise defined shall have the meanings and definitions ascribed to them as listed below.

1.1.           “Adverse Event” means any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An Adverse Event can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to such medicinal product.

1.2.           “Affiliate” means any corporation, company, joint venture, partnership or other entity which, directly or indirectly, controls, is controlled by, or is under common control with a Party to this Agreement. “ Control ” means the ownership of at least 50% of the issued share capital or business assets of another entity, the power to exercise at least 50% of the voting rights of another entity, or the power to appoint more than 50% of the Board of Directors of another entity.

1.3.           “Angiomax” means Angiomax ^® , Angiox ^® , Angionax ^® or any other Trademark selected by TMC for the Product in the Territory.

1.4.           “Approvals” means and includes all filings, approvals, registrations, permits, licenses and authorizations related to the Product which are necessary or which, in the reasonable opinion of TMC, are desirable, to be made with or obtained from any Governmental Authority for the importation, sale, marketing and promotion of the Product in the Territory or any part thereof, including primarily, but without limitation, authorizations of medicinal products for human use and approval of related labels and packaging, as well as pricing and social health system reimbursement approvals.

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1.5.           “AQRPA” means the Analysis, Quality Release and Packaging Agreement, entered into as of March 24, 2004, between TMC and Nycomed.

1.6.           “Business Day” means any day on which the banks in the Kingdom of Denmark are open for business.

1.7.           “Combination Product” means a product containing one or more active ingredients or components in addition to the Product.

1.8.           “Distributor” means a person or entity in a country who (i) purchases Product from Nycomed or one of its Affiliates, and (ii) assumes responsibility for a portion of the sales effort related to Product in that country, and (iii) under an implied or express sublicense, sells Product in that country.

1.9.           “EEA” means any current member countries of the European Union and Norway, Iceland, and Liechtenstein.

1.10.         “Existing Inventory” means all labeled and unlabeled vials of Product held by Nycomed or Nycomed’s Affiliates in inventory on the Effective Date until sold or supplied by Nycomed pursuant to Section 9.

1.11.         “Existing Subdistributors” means those Nycomed Affiliates appointed by Nycomed prior to the Effective Date, in accordance with the Former Distribution Agreement, as Distributors of the Product in the Territory, and such additional Nycomed Affiliates and other third parties appointed as Distributors of the Product in the Territory in accordance with Section 2.1.

1.12.         “First Launch Date” means the date of Launch of the Initial Indication(s) in any country of the Territory.

1.13.         “Governmental Authority” means and includes all governmental and regulatory bodies, agencies, departments or entities, whether or not located in the Territory, which regulate, direct or control commerce in or with the Territory, including Approvals.

1.14.         “Gross Sales” means gross invoices on sales of the Product by Nycomed and its Affiliates and Distributors to third parties.

1.15.         “ Grupo Ferrer ” means Grupo Ferrer Internacional S.A.

1.16.         “Improvements” means authorized, updated or modified manufacturing processes for the Product or its component substances, additional dosage unit sizes or other similar authorized modifications to the production and delivery of the Product as part of an Approval for the Product.

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1.17.         “Indication” means a particular use for the Product which has received Approval from a Governmental Authority in one or more countries of the Territory.

1.18.         “Initial Indication” means the Product’s first Indication receiving Approval in one or more countries of the Territory.

1.19.         “Inventory” means the Existing Inventory and the New Inventory, collectively.

1.20.         “ ISAR Agreements ” means:

(a)            [**], effective as of [**] (the “ ISAR-4 Agreement ”);

(b)            [**], effective as of [**] (the “ Munich ISAR-3 Agreement ”);

(c)            [**], effective as of [**] (the “ Bad Krozingen ISAR-3 Agreement ”);

(d)            [**], with last signature dated [**] (the “ ISAR-3 Reload Agreement ”; the Munich ISAR-3 Agreement, Bad Krozingen ISAR-3 Agreement and the ISAR-3 Reload Agreement, collectively, the “ ISAR-3 Agreements ”).

1.21.         “Launch” means the date of announcement to prescribers of pharmaceuticals, of the availability of Product upon prescription to treat an Initial Indication or a subsequent Indication in any country in Territory.

1.22.         “Net Sales” shall mean the gross amount invoiced (not dependent on whether such invoices have been actually paid) on sales of the Product by Nycomed and its Affiliates and Distributors to third parties, less the following items, as determined from the books and records of Nycomed or its Affiliates or Distributors, provided that such items do not exceed reasonable and customary amounts in the respective country(s) of the Territory in which such sale or other disposition occurred:  (i) freight, insurance and other transportation charges, if billed separately; (ii) amounts repaid or credited by reason of returns, rejections, defects, recalls or because of retroactive price reductions; (iii) sales taxes, excise taxes, value-added taxes and other taxes (other than income taxes) levied on the invoiced amount; (iv) import and export duties; (v) cash, trade and quantity discounts actually given or made; and (vi) rebates paid pursuant to government regulations. A sale of the Product by Nycomed to an Affiliate or Distributor for resale of the Product by such Affiliate or Distributor shall not be considered a sale for the purposes of this provision, but the resale of such Product by the Affiliate or Distributor to a third party who is not an Affiliate or Distributor of Nycomed shall be a sale for the purposes of this Agreement.

For the purposes of this Agreement, “ sale ” shall mean any transfer or other distribution or disposition, but shall not include transfers or other distributions or dispositions of Product, at no charge, for pre-clinical, clinical or regulatory purposes or to physicians or hospitals for

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promotional purposes, provided such transfer, distribution or disposition is not made in exchange for higher prices on other Nycomed products or for other non-cash consideration. In the event that consideration in addition to or in lieu of money is received for the sale of Product in an arms-length transaction, the fair market value of such consideration shall be included in the determination of Net Sales. To the extent that the Product is sold in other than an arms-length transaction, Net Sales for such sale shall be the average sales price of the Product if sold in an arms-length transaction during the applicable reporting calendar quarter in the country of the Territory in which the non-arms-length transaction occurred.

In the event that the Product is sold in the form of a Combination Product, Net Sales for the Combination Product shall be determined by multiplying actual Net Sales of the Combination Product (determined by reference to the definition of Net Sales set forth above) during the calendar quarter period by the fraction A/A+B where A is the average sale price of Product when sold separately in finished form, and B is the average sale price of the other active ingredients or components when sold separately in finished form, in each case during the applicable reporting calendar quarter in the country in which the sale of the Combination Product was made, or if sales of both the Product and the other active ingredients or components did not occur in such period, then in the most recent calendar quarter in which sales of both occurred. In the event that such average sale price cannot be determined for both Product and all other active ingredients or components included in the Combination Product, Net Sales for purposes of determining payments under this Agreement shall be calculated by multiplying the Net Sales of the Combination Product by the fraction C/C+D where C is the standard fully-absorbed cost of the Product portion of the Combination Product and D is the sum of the standard fully-absorbed costs of all other active components or ingredients included in the Combination Product, in each case as determined by TMC using its standard accounting procedures consistently applied. In no event shall Net Sales of a Product included in a Combination Product be reduced to less than fifty percent (50%) of actual Net Sales of such Combination Product (determined by reference to the definition of Net Sales set forth above) by reason of any adjustment provision set forth in this paragraph.

1.23.         “New Inventory” means any vials of Product bought by Nycomed from TMC after the Effective Date in accordance with Section 8.1.

1.24.         “Packaging Agreement” means the Quality (GMP) Agreement for Third Party Contract Manufacture, entered into as of April 24, 2002, between TMC and Nycomed.

1.25.         “ Patents ” means patents and applications in any and all countries for patents (including provisional applications) and all reissues, divisions, renewals, extensions, continuations and continuations-in-part thereof and patent extensions with respect to the Product in the Territory.

1.26.         “Pharmacovigilance Agreement” means the Pharmacovigilance Agreement on Bivalirudin®, entered into as of September 16, 2004, between TMC and Nycomed.

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1.27.         “Pharmacovigilance QP Agreement” means the Agreement between The Medicines Company and Nycomed Denmark A/S on the role of the Qualified Person for Pharmacovigilance in the European Union for Angiox, entered into as of August 16, 2004, between TMC and Nycomed.

1.28.         “PhV Agreements” means the Pharmacovigilance Agreement and the Pharmacovigilance QP Agreement.

1.29.         “Product” means Bivalirudin, being a highly specific and reversible direct thrombin inhibitor, which operates by specific binding to both the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. The active substance is a synthetic, twenty (20)-amino acid peptide, whose chemical name is D-phenylalanyl-Lprolyl-Larginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartly-L-phenylalanyl-L-glutamyl-L-glutamyl-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine-trifluoracetate (salt) hydrate. Its molecular weight is 218.19 daltons (anhydrous free base peptide). Product shall also include Improvements.

1.30.         “Product Configuration” means and includes any modifications to the package insert, labeling, or packaging of the Product required by Governmental Authority(s) of one or more countries of the Territory.

1.31.         “PTC” means the Product Transition Committee, as defined in the Transition Agreement.

1.32.         “QA Agreements” means, collectively, the AQRPA, the Release Agreement and the Packaging Agreement.

1.33.         “Quality Agreements” means, collectively, the QA Agreements and the PhV Agreements. For the sake of clarity, with respect to each Quality Agreement, all references to such Quality Agreement with respect to activities pursuant to the Former Distribution Agreement (i.e., prior to the Effective Date) shall mean such Quality Agreement unamended by the Transaction Agreements, and all references to such Quality Agreement with respect to activities on or after the Effective Date shall mean such Quality Agreement as amended by the Transaction Agreements.

1.34.         “Release Agreement” means the Quality (GMP) Agreement for Third Party Contract Quality Release, entered into as of February 24, 2004, among TMC, Nycomed and Nycomed Austria GmbH.

1.35.         “Thrombin Inhibitor” means any pharmaceutical with a mechanism of action involving the partial or complete inhibition of thrombin in the clotting cascade. Thrombin inhibitors shall include direct acting compounds including but not limited to lepirudin, desirudin and other

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members of the hirudin family as well as melagatran and small molecule direct thrombin inhibitors such as argatroban. Thrombin inhibitors shall also include indirect acting thrombin inhibitors which inhibit thrombin in conjunction with a co-factor such as AT-III. Such indirect thrombin inhibitors shall include but not be limited to unfractionated heparins and low molecular weight heparins such as enoxaparin sodium, dalteparin sodium, fondaparinux and reviparin sodium but shall exclude Warfarin.

1.36.         “TMC-UK” means The Medicines Company UK Limited, a limited liability corporation located at Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, or such other EU incorporated entity of TMC which TMC may designate.

1.37.         “Trademarks” means trademarks, trade names, service marks, and other proprietary symbols owned or controlled by TMC and as designated by TMC in Exhibit C hereto.

1.38.         “Transaction Agreements” means, collectively, this Agreement, the Services Agreement and the Transition Agreement.

1.39.         “Transfer Percentage” means (a) with respect to sales of Inventory made on or before June 30, 2008, [**]%, and (b) with respect to sales of Inventory on or after July 1, 2008, [**]%; provided , however , that if TMC requires Nycomed to perform quality analysis activities on more than [**] batches per year, the Parties shall negotiate a reasonable fee to be paid by TMC to Nycomed with respect to such activities, reflecting Nycomed’s actual costs to perform such activities, marked up by [**]%, but in no event more than €[**] per analysis.

1.40.         “ Transfer Price ” has the meaning set forth in Exhibit B .

2.              APPOINTMENT OF NYCOMED

2.1.           Appointment, General Diligence .

TMC hereby appoints Nycomed as an exclusive distributor of the Product in the Territory for any and all Indications (whether or not currently existing or planned, but subject to Section 3.1.8 of the Transition Agreement) during the term of this Agreement and Nycomed hereby accepts such appointment subject to the terms and conditions described in this Agreement. For the sake of clarity, such appointment includes the right and obligation for Nycomed to conduct the following activities with respect to the Product in the Territory in accordance with Nycomed’s past practice under the Former Distribution Agreement and Quality Agreements:  importation, warehousing, logistical/handling, transportation, packaging and labeling, QA and QC (including release analysis), follow-up stability studies, order entry activities, booking of sales, billing and collection, product recall (as provided herein) and any other activity performed under the Former Distribution Agreement and Quality Agreements which is not considered a “Service” under the Services Agreement, and expressly excludes the

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right and obligation to conduct promotion, marketing, detailing and other Services (as defined in the Services Agreement) with respect to the Product in the Territory, except as expressly provided in the Services Agreement. In addition, Nycomed shall have no right or obligation to purchase Product except in accordance with Section 8.1. Nycomed shall have the right to retain the Existing Subdistributors as subdistributors of the Product in the Territory. Nycomed may appoint Nycomed’s Affiliates or third parties as subdistributors of the Product in the Territory. Promptly after any such appointment, Nycomed shall notify TMC in writing of the name and address of each Nycomed Affiliate or third party so appointed as a subdistributor.

2.2.           Application to Affiliates .

The Parties agree and acknowledge that Nycomed has performed certain of its obligations under the Former Distribution Agreement through Nycomed’s Affiliates and that Nycomed may perform certain of its obligations under this Agreement, the QA Agreements and the Pharmacovigilance Agreement through Nycomed’s Affiliates. Nycomed shall cause its Affiliates to comply with all of Nycomed’s obligations under this Agreement, the QA Agreements and the Pharmacovigilance Agreement to the same extent that Nycomed is itself obligated to perform hereunder or thereunder and Nycomed shall be responsible for any failure by any Affiliate to do so. Except as otherwise expressly stated herein, any references to Nycomed in this Agreement, the QA Agreements and the Pharmacovigilance Agreement shall also apply to Nycomed’s Affiliates to the extent such Affiliates have performed or will perform Nycomed obligations hereunder or thereunder.

2.3.           General Obligations and Limitations with respect to Distribution .

(a)            Subject to the applicable regulations in the Territory and to the extent permitted by law, Nycomed shall not (i) establish or maintain any distribution facility for the Product outside the Territory or (ii) except as permitted under the Services Agreement, actively advertise or promote the Product to potential buyers, whether located within or outside the Territory. Nycomed agrees and acknowledges that, as between Nycomed and Nycomed’s Affiliates, on the one hand, and TMC and TMC’s Affiliates, on the other hand, TMC and its Affiliates shall be responsible for the advertising, promotion, detailing and marketing of the Product to potential buyers in the Territory, and, except to the extent specified in the Services Agreement, Nycomed, Nycomed’s Affiliates and any Existing Subdistributors shall have no right or obligation to conduct such activities. Particularly, Nycomed is cognizant of and recognizes the exclusive distribution rights granted by TMC to Grupo Ferrer for Spain, Portugal and Greece and for certain countries within Central and South America.

(b)            Nycomed shall not seek Approval for the Product anywhere in any country in the world, except as provided in the Transition Agreement or with TMC’s prior written consent with respect to a particular country.

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(c)            Nycomed shall not bundle the Product with other products.

(d)            Nycomed shall use commercially reasonable efforts to distribute and sell the Products in the Territory and in doing so to maximize the Net Sales of the Product. Nycomed shall use all reasonable efforts to continue to follow the sales and pricing practice and policies with respect to the Product in the Territory that Nycomed has followed in the 12 month period immediately prior to the Effective Date, except to the extent it has just cause to deviate from the same.

2.4.           Non-Competition .

During the term of this Agreement, none of Nycomed, its Affiliates or its Distributors shall manufacture, distribute or sell any Thrombin Inhibitor in the Territory; provided , however , that with respect to countries in the Territory which are included in the EEA, this sentence shall only apply from the First Launch Date until the date which is five years after the First Launch Date. During the term of this Agreement, Nycomed shall notify TMC regarding new pharmaceutical products (excluding line extensions and new formulations) Nycomed or its Affiliates intend to directly or indirectly sell, market or promote in the Territory. Notwithstanding the above, Nycomed shall be entitled to distribute any product for the same Indications as approved for the Product, other than abciximab, eptifibatide, or enoxaparin sodium, that may be used with the Product and/or which may be used in circumstances where the Product is not currently indicated or is contraindicated. Notwithstanding anything contained herein to the contrary, Nycomed shall not be deemed to be in breach of this Section 2.4 if any of the customers of Nycomed, its Affiliates or its Distributors outside the Territory resell any Thrombin Inhibitor in the Territory which they purchased from Nycomed, its Affiliates or its Distributors.

3.              RELATIONSHIP WITH CERTAIN OTHER AGREEMENTS

3.1.           Former Distribution Agreement .

Except with respect to the services to be provided by Nycomed pursuant to the Services Agreement and except as otherwise expressly provided herein, Nycomed shall perform hereunder all activities which Nycomed had performed under the Former Distribution Agreement without interruption and in accordance with Nycomed’s practice under the Former Distribution Agreement. Nycomed shall maintain the infrastructure and personnel necessary to perform its obligations under this Agreement.

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3.2.           QA and Pharmacovigilance Agreements .

The QA Agreements and the Pharmacovigilance Agreement shall remain in effect unless terminated in accordance with Section 20 of this Agreement; provided , however , that the QA Agreements and the Pharmacovigilance Agreement are hereby amended as follows:

(a)            All references in the AQRPA, the Release Agreement, the Packaging Agreement and the Pharmacovigilance Agreement to the Former Distribution Agreement or “SMD” (as defined in such Quality Agreements) shall instead refer to this Agreement; provided , however , that (i) all references in the AQRPA to Section 8.2 of the SMD with respect to the authorized manufacturer of the Product or the analyses for import and final release of the Product in the Territory shall instead refer to Section 8.1 of this Agreement, and (ii) all references in the AQRPA to Sections 8.2 and 8.3 of the SMD with respect to final packaging of the Product shall instead refer to Sections 8.2 and 10.3(b) of this Agreement.

(b)            The “Termination” section and the “Consideration:  For the Release” section in the AQRPA is hereby deleted in its entirety.

(c)            Appendix 2 to the Release Agreement is revised to refer to the TMC Specifications and TMC-UK Specifications agreed upon by the Parties and approved in the Territory.

(d)            For the sake of clarity, Nycomed shall continue, unless requested to the contrary by TMC, the arrangements that were in place with respect to Grupo Ferrer during the term of the Former Distribution Agreement in accordance with past practice during such term, including the performance of services under this Agreement, the QA Agreements and the Pharmacovigilance Agreement and the sale of Product to Grupo Ferrer.

4.              PTC, TMs AND ADVISORY BOARDS

4.1.           Coordination .

As described in the Transition Agreement, the Transition Managers (as defined in the Transition Agreement) and the PTC shall be responsible for coordinating the Parties’ activities under this Agreement. The QP (as defined in the relevant QA Agreement) shall cooperate with the PTC as requested by TMC.

4.2.           Advisory Boards .

For the purpose of maximizing the medical community’s knowledge and awareness of the Product, to the extent Nycomed has developed national or regional advisory boards for the Product pursuant to the Former Distribution Agreement, the members and meetings of such

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boards shall be accessible to TMC’s personnel. For the avoidance of doubt, Nycomed shall no longer have any right to develop new national or regional advisory boards, but may maintain the existing boards in accordance with this Section 4.2 until termination or expiration of this Agreement, at which point such boards shall be disbanded.

5.              COMPLIANCE WITH GOVERNMENTAL REGULATIONS

TMC and Nycomed shall each comply with all laws, rules and regulations of every Governmental Authority having jurisdiction over its respective activities, as contemplated by this Agreement.

6.              INTENTIONALLY OMITTED

7.              FORECASTS

Until [**] (or, if earlier, the termination of this Agreement), Nycomed shall provide TMC with a [**] Product forecast, updated on a rolling quarterly basis. The rolling forecasts are to be broken down to [**]. Nycomed shall use its reasonable commercial efforts to provide accurate forecasts to TMC. Such forecasts shall be non-binding.

8.              INVENTORY MANAGEMENT AND SUPPLY

8.1.           New Inventory .

(a)            At TMC’s request from time to time, Nycomed shall buy New Inventory from TMC, based on TMC’s good faith belief as to the anticipated demand for the Product in the Territory during the remaining term of this Agreement. Nycomed shall pay TMC for such New Inventory in accordance with Section 10 of this Agreement. TMC shall supply the New Inventory as a sterile lyophilized formulation in 10 ml glass vials containing material that, when reconstituted, will deliver 250mg of bivalirudin per 5ml. Each 250mg vial constitutes a single unit of Product.

(b)            The New Inventory shall be provided to Nycomed by TMC in 250 mg naked (unlabeled) vials in quantities determined by TMC. Naked vials shall be shipped to an agreed location in the European Union. TMC shall be responsible for the cost of filling the naked vials at Ben Venue Laboratories. Additionally, TMC may designate another qualified company in Europe or elsewhere that shall be responsible for filling the naked vials, and TMC shall provide all required technical know-how to the designated company for such purposes. TMC shall be responsible for the cost of filling, both at Ben Venue and at any such additional site. As marketing authorization holder, TMC shall be responsible for designating an authorized manufacturer and/or site of European batch release for the Product; provided , however , that

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TMC has designated Nycomed to act in this capacity in accordance with the Release Agreement; provided , however , that TMC also reserves the right to designate other third parties as appropriate.

(c)            TMC shall deliver New Inventory into the possession of a common carrier designated by TMC. Title, risk of loss and damage to such Product shall pass to Nycomed upon such Product’s removal from TMC’s designated filling location. In accordance with Section 10.3(a), TMC shall be responsible for shipping and insurance costs incurred in connection with transporting the New Inventory from TMC’s fill point to the agreed location in the European Union. The New Inventory shall be packed for shipment and storage in accordance with TMC’s standard commercial practices.

(d)            For the avoidance of doubt, Nycomed shall be the importer of record with respect to the New Inventory. Until Nycomed sells or supplies the New Inventory in accordance with Section 9, the New Inventory shall be housed and maintained by Nycomed, at Nycomed’s expense, at a facility(ies) owned or controlled by Nycomed and will be segregated and marked as New Inventory.

(e)            The terms and conditions set forth in this Agreement shall apply to all purchases of New Inventory by Nycomed, and to the extent such terms and conditions conflict with those set forth in any purchase order or invoice for Product, the terms and conditions set forth in this Agreement shall govern.

(f)             TMC shall not be liable to Nycomed for any losses or damages arising from TMC’s failure to provide any quantity of Product.

8.2.           Product Packaging, Product Configuration and Destination Instructions .

(a)            Nycomed will be responsible for the Product Configuration except with respect to those countries in the Territory in which TMC holds the marketing authorization for the Product. TMC shall approve all labeling and package insert proofs prior to their use.

(b)            Nycomed shall package and label the Product in Inventory in accordance with TMC’s instructions, Nycomed’s past practices with respect thereto, the provisions of this Agreement and the Packaging Agreement, and applicable Territory laws and regulations.

8.3.           Inspection; Repurchase; Possession .

(a)            TMC shall have the right to enter the applicable distribution facilities at all reasonable times to inspect the Inventory and Nycomed’s records with respect thereto. At TMC’s request from time to time, Nycomed shall provide TMC with a report of the quantity of saleable Inventory and such other information reasonably requested by TMC with respect to the Inventory.

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(b)            Upon TMC’s request at any time, (i) Nycomed Danmark ApS shall obtain title and ownership of any of the then-current New Inventory that may be held by its Affiliates, (ii) TMC or TMC’s designee shall purchase, and shall be deemed to have purchased, the then-current New Inventory from Nycomed Danmark ApS at no charge (US$0) and (iii) title to the then-current New Inventory shall pass to TMC or TMC’s designee. Nycomed Danmark ApS shall execute and deliver to TMC or TMC’s designee, as applicable, a bill of sale with respect to such then-current New Inventory substantially in the form attached to the Transition Agreement as Exhibit C (with relevant changes to refer to the then-current New Inventory). Nycomed shall deliver such vials of New Inventory into the possession of a common carrier designated by TMC within five Business Days after Nycomed’s receipt of TMC’s request. If TMC does not designate a common carrier before such date, then Nycomed may designate a common carrier on behalf of TMC. Title, risk of loss and damage to such vials of New Inventory shall pass to TMC or TMC’s designee, as applicable, upon possession by the common carrier. Such vials of New Inventory shall be delivered FCA (Incoterms 2000) the applicable Nycomed distribution facility. Such vials of New Inventory shall be packed for shipment and storage in accordance with Nycomed’s standard commercial practices. Nycomed shall deliver such vials of New Inventory in good and merchantable quality and in saleable condition in the ordinary of course of business as conducted in accordance with Nycomed’s past practice. Nycomed agrees that, if Nycomed does not comply with Nycomed’s obligations under this Section 8.3(b), TMC has the right to enter the Nycomed distribution facilities, take possession of any or all of the New Inventory and remove any or all of the New Inventory from such facilities, without further notice or court hearings, which rights, if any, are hereby waived, upon expiration or termination of this Agreement. For the sake of clarity, TMC’s rights and Nycomed’s obligations under this Section 8.3(b) are independent of and in addition to the Parties’ rights and obligations under Section 6.10 of the Transition Agreement.

8.4.           Certificates of Analysis .

Except to the extent that Nycomed is responsible for performing the relevant activities pursuant to the QA Agreement, (a) TMC shall provide Certificat