-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, UbZmplRMIX5fQa1emVshWqSaqea49BXsUg3bkQpNUfuyLu+g1aZsP03f5YxJ5C7t +nOj8WVUnodUsbfFpzsXOw== 0001104659-09-041104.txt : 20090701 0001104659-09-041104.hdr.sgml : 20090701 20090630183041 ACCESSION NUMBER: 0001104659-09-041104 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20090630 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090701 DATE AS OF CHANGE: 20090630 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMAG PHARMACEUTICALS INC. CENTRAL INDEX KEY: 0000792977 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 042742593 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14732 FILM NUMBER: 09920274 BUSINESS ADDRESS: STREET 1: 100 HAYDEN AVENUE CITY: LEXINGTON STATE: MA ZIP: 02140 BUSINESS PHONE: 6174972070 MAIL ADDRESS: STREET 1: 100 HAYDEN AVENUE CITY: LEXINGTON STATE: MA ZIP: 02140 FORMER COMPANY: FORMER CONFORMED NAME: ADVANCED MAGNETICS INC DATE OF NAME CHANGE: 19920703 8-K 1 a09-16940_18k.htm 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): June 30, 2009

AMAG PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

0-14732		04-2742593
(Commission File Number)		(IRS Employer Identification No.)

100 Hayden Avenue
Lexington, Massachusetts		02421
(Address of principal executive offices)		(Zip Code)

(617) 498-3300

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01. Other Events.

On June 30, 2009, AMAG Pharmaceuticals, Inc., or the Company, announced that the U.S. Food and Drug Administration has granted marketing approval for Feraheme™ (ferumoxytol) Injection for intravenous, or IV, use, as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. The recommended dose of Feraheme is an initial 510 mg IV injection followed by a second 510 mg IV injection three to eight days later. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.

Feraheme is expected to be commercially available in the U.S. during the second half of July 2009. Feraheme will be distributed primarily through wholesalers and specialty distributors. The Company will market and sell Feraheme through its commercial organization consisting of approximately 150 seasoned professionals, including an 80-person specialized sales force, an experienced account management and reimbursement team, and a contract nurse team.

The press release, dated June 30, 2009, is filed as Exhibit 99.1 to this report and is incorporated herein by reference.

In connection with the planned commercial launch of Feraheme, the Company and Catalent Pharma Solutions LLC, or Catalent, entered into a Commercial Packaging Services Agreement, dated May 29, 2009, or the Catalent Agreement, pursuant to which Catalent agreed to provide certain labeling, packaging and other related services to the Company in connection with the marketing and sale of Feraheme.

In addition, in October 2008, the Company entered into a Commercial Outsourcing Services Agreement, or the ICS Agreement, with Integrated Commercialization Services, Inc., or ICS, pursuant to which ICS is to serve as the Company’s exclusive third party logistics provider to support the U.S. commercialization of Feraheme. The logistics services to be provided to the Company by ICS include customer services support, warehousing and inventory program support, distribution services support, contract administration and chargeback processing services, accounts receivable management and cash application services and financial management services.

The foregoing descriptions of the ICS Agreement and the Catalent Agreement contained in this Item 8.01 do not purport to be complete descriptions of the rights and obligations of the parties thereunder and are qualified in their entirety by reference to the full text of the contracts that are filed as Exhibits 10.1 and 10.2 to this Current Report on Form 8-K and incorporated herein by reference. Certain portions of these agreements have been omitted from this Current Report on Form 8-K and the versions of the agreements attached as Exhibit 10.1 and 10.2 hereto pursuant to a Confidential Treatment Request that the Company filed with the Securities and Exchange Commission at the time of filing this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The Company hereby files the following exhibits:

10.1 Commercial Outsourcing Services Agreement, dated October 2008, by and between the Company and Integrated Commercialization Services, Inc. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission.)

10.2 Commercial Packaging Services Agreement, dated May 29, 2009, by and between the Company and Catalent Pharma Solutions LLC. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission.)

99.1 Press Release dated June 30, 2009.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	AMAG PHARMACEUTICALS, INC.


	By:	/s/ Joseph L. Farmer
		Joseph L. Farmer
		General Counsel and Senior Vice
		President of Legal Affairs


	Date: June 30, 2009

EXHIBIT INDEX

Exhibit Number		Description

10.1		Commercial Outsourcing Services Agreement, dated October 2008, by and between the Company and Integrated Commercialization Services, Inc. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission.)

10.2		Commercial Packaging Services Agreement, dated May 29, 2009, by and between the Company and Catalent Pharma Solutions LLC. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission.)

99.1		Press Release dated June 30, 2009.

EX-10.1 2 a09-16940_1ex10d1.htm EX-10.1

Exhibit 10.1

COMMERCIAL OUTSOURCING SERVICES AGREEMENT

This Commercial Outsourcing Services Agreement (“Agreement”) is entered into as of October , 2008 (the “Effective Date”) by INTEGRATED COMMERCIALIZATION SOLUTIONS, INC., a California corporation (“ICS”) and AMAG PHARMACEUTICALS, INC., a Delaware corporation (the “Company”).

RECITALS

A. Company is, among other things, in the business of manufacturing, selling and distributing pharmaceutical products, including those listed on Schedule A (“Products”);

B. ICS is, among other things, in the business of providing commercialization services for pharmaceutical products;

C. The Company desires to engage ICS as its agent to provide certain commercialization services related to Products pursuant to this Agreement; and

D. ICS desires to provide such commercialization services to the Company as its agent pursuant to this Agreement.

AGREEMENT

NOW, THEREFORE, the parties hereby agree as follows:

1. Appointment As Exclusive Agent

The Company hereby appoints ICS as the exclusive provider of Services (as defined in Section 2) for Products sold to the Company’s customers (“Customers”) in the United States, Guam, Puerto Rico and the U.S. Territories during the Term (as defined in Section 4.1), as provided in this Agreement.

2. Services To Be Performed

The Company hereby engages ICS to provide the following services with respect to Products (“Services”):

2.1 Customer Services as described in Exhibit B.

2.2 Warehousing and Inventory Program Services as described in Exhibit C.

2.3 Distribution Services as described in Exhibit D.

2.4 Contract Administration and Chargeback Processing as described in Exhibit E.

2.5 Accounts Receivable Management and Cash Applications as described in Exhibit F.

2.6 Financial Management Services as described in Exhibit G.

2.7 Information Technology Services as described in Exhibit H.

2.8 Government Contracting and Reporting Services as described in Exhibit I.

2.9 Solely for the limited purpose of compliance with the pedigree requirements of the Prescription Drug Marketing Act and any similar state laws, ICS shall be considered an

“Authorized Distributor of Record” for the Products and a third party logistics provider who does not take title to Product or have general responsibility to direct the Product’s sale or disposition. The foregoing shall not be construed in a manner that results in ICS being considered a distributor or wholesaler for any other purpose or under any other law or regulation.

2.10 ICS will not be responsible for collection or payment of any Taxes on behalf of the Company.

2.11 Capitalized words used without definition in this Agreement will each have the meaning in Schedule C.

3. Compensation - - Fees For Services

3.1 Compensation. The Company will compensate ICS for Services in accordance with Schedule B. ICS will provide monthly invoices for fees for Services to the Company, and will bill the Company for any pass through charges that have been previously approved (except freight) by the Company on a monthly basis or as ICS is billed. The Company will notify ICS of any disputed charges in writing within 30 days of the date of the invoice covering such charges. In the absence of any such notice of dispute, all invoices will be deemed to be correct and due in full within 30 days of the invoice date. If the Company disputes a portion of an invoice, the Company shall pay the undisputed portion of the invoice within 30 days of the invoice date. A late fee of 1.5% per month (or any portion thereof) will be charged as of the due date on all amounts not paid within thirty (30) days of the invoice date, except any amount disputed by the Company in good faith. If any dispute is resolved in favor of ICS, the Company will pay the applicable late fee on such amount from the original due date.

3.2 Cost Adjustment. If ICS can reasonably demonstrate to the Company that the costs to ICS for providing Services have materially increased (or are reasonably likely to increase materially during the following twelve (12) month period of the Term) as a result of any changes in the Requirements of Law, including the adoption of any new Requirements of Law impacting Services, then ICS may increase the applicable component of the fees for such Services provided in Schedule B (“Cost Adjustment”). ICS will notify the Company of any proposed Cost Adjustment at least one hundred fifty (150) days prior to its effective date. All Cost Adjustments will be determined under generally accepted accounting principles (GAAP) and cost allocation methods applied on a consistent basis. If the Company objects to any Cost Adjustment and the parties are unable in good faith to resolve such objection to the reasonable satisfaction of both parties, then either party may terminate this Agreement upon ninety (90) days’ prior written notice to the other party.

3.3 Program Ready Date. If the Company requests that ICS delay the launch of Services beyond the agreed-upon date on the signatory page (the “Program Launch Date”), the Company will pay ICS a program ready fee and any associated expenses as specified in Schedule B, including reasonable out-of-pocket costs and other expenses. The Company will give ICS at least [***] written notice of changes to the Program Launch Date. Program ready fees will continue until the Program Launch Date. After the Program Launch Date, the Company will pay applicable monthly program fees. For the first month during which Services are provided, ICS will prorate any difference between program ready fees and applicable monthly program fees.

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

4. Term And Termination

4.1 Initial Term. This Agreement will be effective as of the Effective Date and will continue for [***] years (the “Term”) unless sooner terminated. The Term may be extended upon written mutual agreement of the parties, such extension to be negotiated in good faith six (6) months prior to the expiration of the Term.

4.2 Termination For Breach.

4.2.1 If a party fails to pay any amount due to the other party under this Agreement, the other party may provide notice to the non-paying party specifying the amount due and notifying the non-paying party that the other party may terminate this Agreement if the non-paying party fails to pay the amount due within five days of the date the notice is received. If the non-paying party fails to pay the amount due within five days of the date the notice is received, the other party may terminate this Agreement immediately and, in such event, shall provide written notice thereof to the non-paying party; provided that if such breach occurs more than three times during any 12-month period, the non-breaching party may terminate this Agreement upon five days’ written notice without any opportunity for cure.

4.2.2 If a party fails to perform any other material obligation under this Agreement, the other party may provide notice to the breaching party describing the breach in detail and notifying the breaching party that the other party may terminate this Agreement if the breaching party’s failure to perform is not cured within 30 days of the date of the notice. If the breaching party’s failure to perform is not cured within 30 days of the date of the notice, then the other party may terminate this Agreement immediately and, in such event, shall provide written notice thereof to the non-paying party; provided that (i) if the breaching party has begun to cure a non-monetary breach within such 30 days, but such cure is not completed to the non-breaching party’s reasonable satisfaction within such 30 days, the breaching party will have up to an additional 30 days to complete such cure (it being understood that if such cure is not completed to the non-breaching party’s reasonable satisfaction within such supplemental 30-day period, then the non-breaching party may terminate this Agreement immediately upon written notice to the breaching party), and (ii) if such breach occurs more than three times during any 12-month period, the non-breaching party may terminate this Agreement upon 30 days’ written notice without any opportunity for cure.

4.3 Termination For Specific Events. Either party may immediately terminate this Agreement upon written notice to the other party upon the other party’s: (a) filing an application for or consenting to appointment of a trustee, receiver or custodian of its assets; (b) having an order for relief entered in Bankruptcy Code proceedings; (c) making a general assignment for the benefit of creditors; (d) having a trustee, receiver, or custodian of its assets appointed unless proceedings and the person appointed are dismissed within 30 days; (e) insolvency within the meaning of Uniform Commercial Code Section 1-201 or failing generally to pay its debts as they become due within the meaning of Bankruptcy Code Section 303(h)(1), as amended; or, (f) certification in writing of its inability to pay its debts as they become due (and either party may periodically require the other to certify its ability to pay its debts as they become due) (each, a “Bankruptcy Event”). Each party agrees to provide immediate notice to the other party upon a Bankruptcy Event.

4.4 [***]

4.5 [***]

4.6 Expenses. Within five days of expiration or earlier termination of this Agreement for any reason, the Company will (a) pay ICS any amount owed up to the effective date of termination; (b) return to ICS all hardware, software and other equipment provided to Company by ICS, or pay to ICS the replacement cost of items not returned; and (c) pay non-recoverable out-of-pocket expenses for telecommunication, facsimile, postage, shipping and other services incurred by ICS up to the effective date of termination.

4.7 Survival. Accrued payment, indemnity, intellectual property and confidentiality obligations, and any provision if its context shows that the parties intended it to survive, will survive expiration or termination of this Agreement and, except as expressly provided, expiration or termination will not affect any obligations arising prior to the expiration or termination date.

5. Recalls; Other FDA Issues

5.1 Recalls. If the Company conducts a recall, market withdrawal or field correction of any Products (“Recall”), the Company will conduct the Recall or designate a third party to do so and be responsible for all Recall expenses. ICS will comply with the Company’s reasonable requests in the Recall. To the extent that the Recall was not due to ICS’s negligence, the Company will pay or reimburse ICS’s Recall expenses (including reasonable attorneys’ fees). To that extent that the Recall was due to ICS’s negligence, ICS will pay or reimburse the Company’s reasonable documented out-of-pocket Recall expenses (including reasonable attorneys’ fees). Each party will use its best efforts to minimize Recall expenses. The Company will notify ICS of any proposed Recall as soon as possible and, in any event, will do so within forty-eight (48) hours of initiating a Recall.

5.2 Government Notices. Each party will provide the other with a copy of any correspondence or notices it receives from the FDA, DEA or any counterpart state agency specifically relating to Services or relating to a material violation of any kind that is related to the Product, whether such violation resulted from an act or omission by the Company or by ICS, as soon as possible but no later than three (3) business days following such receipt. In addition, ICS will provide the Company with any notice relating to Products promptly upon its receipt. Each party will also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., such as an FDA 483 notice, warning letters, untitled regulatory letters and establishment inspection reports). Where reasonably possible, ICS will give prior notice to the Company of any scheduled FDA or DEA inspections of ICS’s facilities specifically relating to any Products, and, if reasonably possible, will afford the Company the opportunity to be present at such inspection and to review and contribute to any written response, to the extent permitted by law.

6. Legal Compliance

6.1 General. During the Term, each party will comply with all Requirements of Law. ICS will comply with Requirements of Law related to storage, handling and distribution of

Products. The Company will comply with Requirements of Law related to importation, manufacture, distribution, labeling, storage, sale and handling of Products.

6.2 Food and Drug Act. The Company hereby represents and warrants to ICS that, during the Term (a) no Products delivered by or on behalf of the Company to or on the order of ICS will be, at the time of shipment or delivery, adulterated, misbranded or otherwise prohibited within the meaning of the Act or within the meaning of any applicable state or local law, (b) Products will be, at the time of shipment and delivery to ICS, merchandise that may be introduced and delivered into interstate commerce under the provisions of Sections 404 or 405 of the Act, (c) all Products will be the subject of a duly approved NDA or ANDA and may be legally transported or sold under Requirements of Law, (d) the Company owns or holds the duly approved NDA or ANDA for the Products, or is otherwise considered the “manufacturer” of all Products under the Act and within the meaning of any other applicable federal, state or local law, and (e) all Products will have been approved by each applicable Governmental Authority for commercial sale and shipment within the United States.

7. Representations And Warranties

7.1 By the Company. The Company represents and warrants to ICS that: (a) it has authority to enter into and perform this Agreement without restriction and this Agreement is a valid and binding obligation of the Company, (b) execution, delivery and performance of this Agreement by the Company has been duly authorized by all necessary corporate actions, (c) the Company will obtain and will maintain, in full force and effect, all licenses and permits required under applicable law for the Company to sell and distribute Products under this Agreement prior to the initiation of such sale and distribution, (d) as of the Effective Date, there is no proceeding or investigation pending or threatened that questions validity of this Agreement, marketing authorizations related to Products or actions pursuant to this Agreement, and (e) as of the date that the first Product is distributed by ICS to a customer under this Agreement, no approvals, consents, orders or authorizations of or designation, registration, declaration or filing with any Governmental authority (within the United State) are required for Company’s performance of its obligations under this Agreement, other than any approval already obtained.

7.2 By ICS. ICS represents and warrants to the Company that: (a) it has authority to enter into and perform this Agreement without restriction and this Agreement is a valid and binding obligation of ICS, (b) execution, delivery and performance of this Agreement by ICS has been duly authorized by all necessary corporate actions, (c) ICS has and will maintain in full force and effect, all licenses and permits required under applicable law for ICS to perform the Services under this Agreement, (d) as of the Effective Date, there is no proceeding or investigation pending or threatened that questions validity of this Agreement, ICS’s licenses to warehouse and distribute pharmaceuticals, or any actions pursuant to this Agreement, and (e) as of the date that the first Product is distributed by ICS to a customer under this Agreement, no approval of or filing with any Governmental Authority (within the United States) is required for ICS to perform Services, other than any approvals already obtained.

7.3 Notice of Changes. The Company and ICS will give prompt written notice to the other if it becomes aware during the Term of any action or development that would cause any warranty in this Section 7 to become untrue.

8. Trademarks/Data

Neither party may use the other party’s name, trademarks, service marks, logos, other similar marks, other intellectual property, or other data or information in any manner without its prior written approval, except to satisfy its obligations under this Agreement. Data and information that belong to the Company will be any data and information related to Products (including sales information), except ICS Data. “ICS Data” means data and information that (i) relates to ICS’s processes, reports and services provided to the Company under this Agreement or to its business relationships and transactions with other suppliers, but is not specific to Products or the Company, and (ii) was independently developed by ICS or its Affiliates without use of Company’s Confidential Information. ICS Data, including information and data relating to any of ICS’s customers and their profiles, and any derivative works or aggregations of ICS Data belongs to ICS.

9. Confidentiality

9.1 Existing Agreement. The parties have previously executed a written Confidentiality Agreement (“Confidentiality Agreement”), attached as Schedule D. The parties will abide by its provisions during the Term and for at least five (5) years thereafter, regardless of any shorter term in the Confidentiality Agreement.

9.2 Termination. Upon expiration or termination of this Agreement for any reason each party will promptly return to the other party all documents and other material containing Confidential Information (as defined in the Confidentiality Agreement), including copies, other than those which a party is reasonably required to maintain for legal, tax or valid business purposes, or if authorized in writing by Company, certify to the other party that it has destroyed all such documentation and other materials.

10. Remedies

10.1 Generally. Rights and remedies under this Agreement are cumulative and in addition to any other available rights or remedies under any agreement, at law or in equity.

10.2 Equitable Relief. If either party violates or threatens to violate Recall, Legal Compliance, Trademark/Data infringement, Confidentiality or other provisions of this Agreement, the other party may suffer irreparable harm and its remedies at law may be inadequate. Accordingly, the other party may seek equitable relief.

10.3 Breach by the Company. Either company acknowledges the difficulty (if not the impossibility) of ascertaining the amount of damages that would be suffered by either on account of the loss of monthly fees or revenues that it would have earned during the remaining months of the Term (the “Lost Profits”), if either party terminates this Agreement following a breach by either company. Accordingly, either company agrees that if either party terminates this Agreement during the Term following a breach by either company, then, as liquidated damages and not as a penalty, the measure of damages payable to either company for the Lost Profits shall be equal to [***] of the aggregate amount of all fees or revenues and other sums that, in absence of such breach, would have been paid by the Company to ICS under this Agreement for the remaining months of the Term[***] with such fees and other sums to be based on the average monthly amount paid or owed by the Company to ICS during the six months preceding such breach (or such shorter time as the Agreement has been in effect) or

for company the average monthly amount of revenues booked into sales. The liquidated damages are intended to compensate either company for Lost Profits only. Either company does not waive and expressly reserves its rights with respect to all other claims or amounts due under this Agreement and the Continuing Guaranty (as defined in Section 13 below). Accordingly, the Lost Profits shall not constitute damages or compensation for any other breach of this Agreement or any other obligation of either company, including but not limited to any claim for indemnification under Section 11 of this Agreement or the Continuing Guaranty.

10.4 LIMITATIONS. EXCEPT FOR EACH PARTY’S OBLIGATIONS OF CONFIDENTIALITY UNDER SECTION 9, INDEMNIFICATION UNDER SECTIONS 11.1 AND 11.2, AND INTELLECTUAL PROPERTY UNDER SECTION 12:

(A) SUBJECT TO SECTION 10.3 ABOVE, NO PARTY WILL BE LIABLE TO ANY OTHER PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL OR OTHER SIMILAR DAMAGES ARISING OUT OF OR IN CONNECTION WITH A BREACH OF THIS AGREEMENT, PROVIDED THAT ANY LOSS DUE TO DAMAGE OR LOSS OF PRODUCTS WILL BE BASED UPON THE COMPANY’S COST OF MANUFACTURING OR ACQUIRING PRODUCTS, NOT ITS SELLING COST;

(B) Subject to Section 10.4(A) above, the Company shall bear all risk of loss or damage with respect to the Product warehoused by ICS except to the extent loss or damage results from the [***]. As used in this Section 10.4(B), the “net amount earned by ICS” shall be calculated in the same manner as lost profits are calculated under Section 10.3. This Section 10.4(B) shall not apply to any claim subject to indemnification under Section 11 that is brought by a third party.

(C) [***]

11. Indemnification

11.1 By the Company. The Company will defend, indemnify and hold harmless ICS and its Related Parties from and against all claims, liabilities, losses, damages, costs and expenses, including reasonable attorneys’ fees (collectively, “Claims”) brought by third parties or the Company’s employees caused by or arising from any (a) act or omission of the Company or its Related Parties, (b) failure of the Company to perform its obligations or to comply with Requirements of Law, (c) breach of any warranty made by the Company in this Agreement (d) claims of patent, trademark, copyright or other infringement related to Products, (e) storage, handling, use, non-use, demonstration, consumption, ingestion, digestion, manufacture, production and assembly of Products and their transportation to ICS, or (f) Taxes imposed against ICS or its Related Parties; provided, however, the Company will have no obligations under this Section 11.1 for any Claims to the extent caused by any negligent act or omission of ICS or its Related Parties.

11.2 By ICS. ICS will defend, indemnify and hold harmless the Company and its Related Parties from and against all Claims brought by third parties or ICS’s employees against

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

the Company or its Related Parties caused by or arising from any (a) negligent act or omission of ICS or its Related Parties, (b) failure of ICS to perform its obligations or to comply with Requirements of Law, (c) breach of any warranty made by ICS in this Agreement, or (d) making by ICS of representations or warranties with respect to Products to the extent not authorized by the Company; provided, however, that ICS will have no obligations under this Section 11.2 for any Claims to the extent caused by any negligent act or omission of the Company or its Related Parties.

11.3 Procedures. The obligations and liabilities of the parties with respect to Claims subject to indemnification under this Section 11, (“Indemnified Claims”), will be subject to the following terms and conditions:

11.3.1 The party claiming a right to indemnification hereunder (“Indemnified Person”) will give prompt written notice to the indemnifying party (“Indemnifying Person”) of any Indemnified Claim, stating its nature, basis and amount, to the extent known. Each such notice will be accompanied by copies of all relevant documentation, including any summons, complaint or other pleading that may have been served or any written demand or other document.

11.3.2 With respect to any Indemnified Claim: (a) the Indemnifying Person will defend or settle the Indemnified Claim, subject to provisions of this subsection, (b) the Indemnified Person will, at the Indemnifying Person’s sole cost and expense, cooperate in the defense by providing access to witnesses and evidence available to it, (c) the Indemnified Person will have the right to participate in any defense at its own cost and expense to the extent that, in its judgment, the Indemnified Person may otherwise be prejudiced thereby, (d) the Indemnified Person will not settle, offer to settle or admit liability in any Indemnified Claim without the written consent of an officer of the Indemnifying Person, and (e) the Indemnifying Person will not settle, offer to settle or admit liability as to any Indemnified Claim in which it controls the defense if such settlement, offer or admission contains any admission of fault or guilt on the part of the Indemnified Person, or would impose any liability or other restriction or encumbrance on the Indemnified Person, without the written consent of an officer of the Indemnified Person.

11.3.3 Each party will cooperate with, and comply with all reasonable requests of, each other party and act in a reasonable and good faith manner to minimize the scope of any Indemnified Claim.

12. Intellectual Property

All concepts, inventions, ideas, patent rights, data, trademarks, and copyrights that are developed by ICS in its performance of this Agreement and are related to Products will remain exclusive property of the Company, except those that are related solely to ICS Data (as defined in Section 8 above). Any concepts, inventions, ideas, patent rights, data, trademarks, and copyrights that are developed by ICS (including its Affiliates) and that relate solely to ICS Data or ICS’s generally applicable methods for providing reports, processes and services will remain the exclusive property of ICS.

13. Insurance

13.1 By the Company. During the Term, the Company will maintain: (a) casualty and theft or loss insurance in amounts sufficient to protect all Products and other materials consigned to ICS, and (b) products liability and commercial general liability insurance having a limit of not less than five million dollars ($5,000,000.00) per occurrence, Combined Single Limit (Bodily Injury and Property Damage), pursuant to one or more insurance policies with reputable

insurance carriers having a Best’s Rating of A VII or otherwise as reasonably approved by ICS. The Company will designate ICS and its Related Parties as “additional insureds” under each such insurance policy. The Company will obtain a broad form vendor’s endorsement for products liability for ICS and its Related Parties. Within thirty (30) days after the Effective Date, the Company will provide to ICS a certificate of insurance indicating that such obligations have been satisfied. As a condition precedent to the effectiveness of this Agreement, the Company will execute the Continuing Guaranty and Indemnification Agreement attached as Exhibit A (the “Continuing Guaranty”)

13.2 By ICS. During the Term, ICS will maintain the following insurance:

13.2.1 Workers’ Compensation. Workers’ compensation statutory coverage as required by law in states where Services are performed;

13.2.2 Employer’s Liability. Employer’s liability insurance with a limit of $500,000 for bodily injury by accident per person, $500,000 for bodily injury by accident, all persons and $500,000 bodily injury by disease policy limit;

13.2.3 General Liability. Commercial general liability insurance, including personal injury blanket contractual liability and broad form property damage, with a $1,000,000 combined single limit;

13.2.4 Umbrella Liability. Umbrella liability insurance in the amount of $5,000,000 per occurrence and aggregate;

13.2.5 Property Insurance. Property insurance covering the business property of ICS and others while at any unnamed location in the amount of $1,000,000; and

13.2.6 Other. ICS will not be obligated to insure Products against any loss or damage to Products arising from the shipment or storage of Products at the ICS Facility.

13.2.7 The insurance required by Section 13 may be made up through a combination of a commercially reasonable self-insured retention program and traditional insurance.

13.3 Notice and Proof of Insurance. Throughout the Term, ICS will (a) provide prompt written notice to the Company in the event ICS becomes aware or is notified that the insurance described in Section 13.2 will be materially adversely modified or cancelled and (b) provide the Company with proof of such insurance.

14. Notices

Notices will be in writing and will be delivered personally (which will include delivery by courier or reputable overnight delivery service) or sent by certified mail, postage and fee prepaid, return receipt requested, to the address on the signature page. Items delivered personally will be deemed delivered on the date of actual delivery. Items sent by certified mail will be deemed delivered on the date the return receipt is signed. A party may change its contact information by a written notice delivered in accordance with this Section 14.

15. Governing Law

This Agreement and the rights and obligations of the parties under this Agreement will be construed and interpreted under the internal laws of the State of Delaware, excluding its conflict and choice of law principles. The successful party in any legal action arising out of this

Agreement, including enforcing its rights in a bankruptcy proceeding, may recover all costs, including reasonable attorneys’ fees.

16. Severability

If any court determines a provision of this Agreement is invalid, such holding will not affect the validity of other provisions and they will remain in effect.

17. Complete Agreement; Amendments; Counterparts; Waivers; Signatures.

This Agreement and its schedules and exhibits, including the Confidentiality Agreement and Continuing Guaranty, contain the entire agreement between the parties and supersede any prior oral and written representations by the parties that relate to the subject matter of this Agreement. This Agreement may not be amended, supplemented or waived in any respect without written agreement of both parties, signed by their respective authorized representatives. This Agreement may be executed in one or more counterparts, which will together constitute but one agreement and each of which will be an original. A party’s failure to insist, in one or more instances, upon performance of any provision of this Agreement will not be construed as a waiver of its right and the other party’s obligations will continue in full force. Either party’s consent to any act by the other party on any occasion will not be deemed consent on any other occasion. Facsimile transmissions bearing a party’s signature will for all purposes be deemed an original. In the event of a conflict between the terms and conditions of the body of this Agreement and those set forth in any schedules or exhibits attached hereto or incorporated herein by reference, the terms set forth in the body of this Agreement will take precedence and control, except with respect to the Continuing Guaranty, which shall supersede any conflicting terms herein.

18. Force Majeure

If the performance of any part of this Agreement by any party will be affected for any length of time by fire or other casualty, government restrictions, war, terrorism, riots, strikes or labor disputes, lock out, transportation delays, electronic disruptions, internet, telecommunication or electrical system failures or interruptions, and acts of God, or any other cause which is beyond control of a party (financial inability excepted), such party will not be responsible for delay or failure of performance of this Agreement for such length of time, provided, however, (a) the affected party will cooperate with and comply with all reasonable requests of the non-affected party to facilitate Services to the extent possible, and (b) the obligation of one party to pay amounts due to any other party will not be subject to the provisions of this Section.

19. Interpretation

The parties have jointly negotiated this Agreement and, thus, neither this Agreement nor any provision will be interpreted for or against any party on the basis that it or its attorney drafted the Agreement or the provision at issue. Headings of the various Sections are not part of the context of this Agreement, and are only labels to assist in locating those Sections, and will be ignored in construing this Agreement. When this Agreement requires approval of one or more parties, such approval may not be unreasonably withheld or delayed. Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender, masculine, feminine, or neuter, as the context requires. “And” includes “or.” “Or” is disjunctive but not necessarily exclusive. “Including” means “including but not limited to.”

20. Successors/Assignment

The parties shall not assign this Agreement without the express written consent of the other party, except that Company may assign or transfer this Agreement (whether by operation of law or otherwise) without such prior consent in connection with a sale, merger, acquisition, or other change in control transaction (including by way of stock sale, merger, reorganization or otherwise), or sale of all or substantially all of Company’s assets (the “Change In Control Transaction”), provided that (i) the Change In Control Transaction includes the assumption of the liabilities under this Agreement and the Continuing Guaranty by the assignee, (ii) the assignee has the financial ability to perform this Agreement and accept all obligations and liabilities hereunder, and (iii) the assignee is not a Competitor (as defined below). In connection with any such permitted assignment or transfer, the assignee shall be obligated under this Agreement with respect to all obligations hereto and agrees to compensate ICS for any additional reasonable and documented services or management fees required to transition the business from Company. In addition, Company will use commercially reasonable efforts to ensure that any prospective assignee execute the standard form Continuing Guaranty and Indemnification Agreement in favor of AmerisourceBergen Corporation and its subsidiaries no later than thirty (30) days following an assignment of this Agreement, provided that if the assignee does not execute the standard form Continuing Guaranty and Indemnification Agreement in favor of AmerisourceBergen Corporation within the thirty (30) day period, Company shall continue to remain liable under the Continuing Guaranty executed by it and attached hereto as Exhibit A until such time as the assignee executes AmerisourceBergen Corporation’s standard form Continuing Guaranty and Indemnification Agreement.

If the assignee fails to execute such agreement within the thirty (30) day period, then ICS shall have the right to terminate this Agreement upon ten (10) days’ notice notwithstanding any provision in this Agreement to the contrary and the assignee shall promptly pay ICS all amounts due under the contract up to and including the effective date of termination. For the purposes of this paragraph, a Competitor includes [***].

21. Relationship Of The Parties

Neither party has any ownership interest in the other and their relationship, as established by this Agreement, is that of agent and master within the confines of the terms of this Agreement. Other than such limited agency, this Agreement does not create any partnership, joint venture or similar business relationship between the parties. Notwithstanding the limited agency created hereunder, each party will remain fully responsible for its actions and the actions of its Related Parties not specifically related to this Agreement.

22. Letter of Intent

Pursuant to Section 17 of this Agreement, the parties’ Letter of Intent dated May 28, 2008, is superseded by this Agreement, provided that, within 30 days after the Effective Date, the Company shall pay ICS [***] in respect of all amounts due under the Letter of Intent.

IN WITNESS WHEREOF, the parties have had a duly authorized officer, partner or principal execute this Commercial Outsourcing Services Agreement as of the Effective Date.

AMAG PHARMACEUTICALS, INC:		INTEGRATED COMMERCIALIZATION SOLUTIONS, INC.


By:	/s/ Brian J. G. Pereira	By:	/s/ David Cheetham

Name:	Brian J. G. Pereira	Name:	David Cheetham

Title:	CEO	Title:	President

Address:		Address:	Attn: Executive Vice President and General Manager 3101 Gaylord Parkway Frisco, TX 75034 with a copy to: AmerisourceBergen Specialty Group Attn: Group Counsel, 1N-E186 3101 Gaylord Parkway Frisco, TX 75034

Program Launch Date: January 15, 2009, unless changed by Company as set forth in Section 3.3

LIST OF SCHEDULES AND EXHIBITS

Schedules:

Schedule A		Description of Products
Schedule B		Summary of Fees
Schedule C		Additional Definitions
Schedule D		Copy of Executed Confidentiality Agreement

Exhibits:

Exhibit A		Continuing Guaranty and Indemnification Agreement
Exhibit B		Customer Services
Exhibit C		Warehousing and Inventory Program Services
Exhibit D		Distribution Services
Exhibit E		Contract Administration and Chargeback Processing
Exhibit F		Accounts Receivable Management and Cash Applications
Exhibit G		Financial Management Services
Exhibit H		IT Services
Exhibit I		Government Contracting and Reporting Services

SCHEDULE A

DESCRIPTION OF PRODUCTS

Description Ferumoxytol

NDC	Volume Per Vial	Milligrams	Vials Per Carton	Carton Dimension
NDC 59338-0771-01	4.25 mL	127.5	1	1 x 1 x 1 15/16H
NDC 59338-0771-10	4.25 mL	127.5	10	4 11/16 x 1 7/8 x 1 15/16H

NDC 59338-0772-01	8.5 mL	255	1	1 1/16 x 1 1/16 x 2 5/16H
NDC 59338-0772-10	8.5 mL	255	10	4 7/8 x 2 x 2 3/8H

NDC 59338-0775-01	17 mL	510	1	1 5/16 x 1 5/16 x 2 5/8H
NDC 59338-0775-10	17 mL	510	10	6 1/4 x 2 1/2 x 2 5/8H

SCHEDULE B

SUMMARY OF FEES

Assumptions:

· AMAG will ship to wholesalers, specialty distributors, large clinics and hospitals and specialty pharmacies

· 852/867 Reporting included in Monthly Management Fee for ABC, McKesson and Cardinal. Any additional reporting may require additional management and development fees

· Standard operation procedures will be followed for all processes. If any custom work instructions are required, the fees listed may be impacted

· AMAG or AMAG vendor will provide initial pedigree in addition to serialized product to ICS; ICS will receive pedigree and transmit as appropriate

Fee	Amount	Description

3PL Services

Development and Implementation	$[***]/one-time	Hiring and training of staff ERP system set up Project management time for implementation Data interface design and testing AMAG-specific telecommunications set up Creation of a AMAG-specific DataMart and RealTime Web Portal

Stand-Ready Fee	$[***]/month	Monthly fee assessed if Program Launch Date is delayed.

Monthly Management Fee

Customer Service Warehouse & Distribution Returns Management Finance Contract & Chargeback Management Lynne Marton Government Contract Consulting and Reporting Services Information Technology & Reporting 852/867 Reporting — ABC, MCK, CAH	$[***]/month	Address customer inquiries as AMAG Manage Customer Relationship Account Set Up License Verification Order Processing Returns Product Inquiries Inventory pick, pack and ship from ICS distribution center AMAG-Branded Packing Slips Daily Cycle Counts One Physical Inventory Count per annum Inventory Management Invoicing as AMAG Establish Credit Limits Process Returns Call Triage Accounts Receivable Management

Fee	Amount	Description

		Collections Maintenance of government and non-government reports Process chargeback requests from wholesalers Debit memo processing Reconciliation reporting AMP and FAMP Reports to AMAG Rebate calculations and reporting to AMAG Admin Fee Calculations Maintenance of AMAG specific DataMart and web reporting tool Maintenance of Crystal Enterprise for web reporting Future upgrades to ICS’ software Includes two licenses to Crystal Enterprise reporting tool

Customer Service Fees

Order Processing Fee	$[*]/order MANUAL $[*]/order EDI	Order is defined as a shipment to a unique address that leaves the distribution center, regardless of the number of cartons or packages that constitute that shipment and/or the number of inbound requests for said Order. Electronic orders are those that are imported into the system automatically without manual intervention from customer service.

Customer Setup Fee	$[***]/account	Assessed for every new account setup completed for an authorized AMAG customer. This includes license receipt and verification after initial launch setup.

Drop Shipment Surcharge	$[***]/order	Assessed in addition to Per Order fees outlined above, when drop shipments are requested. Drop Shipments are defined as shipments that are shipped directly to an end customer of the wholesaler, and invoiced directly to the wholesaler.

Allocation Fee	$[***]/week	Order allocations encompass any inbound orders to ICS that needs to have original conditions revised and/or altered (i.e. manual intervention) as opposed to allowing the order to automatically flow through the order process system. An example of an allocation would be a backorder situation.

Rush Order	$[***]/order	Orders that are received and processed between 3pm and 5pm Eastern Time, at the request of the AMAG.

Emergency Order	$[***]/order	Emergency shipments are defined as any order received outside of scheduled working hours (currently M-F 8am to 5pm Eastern Time) requiring ICS staff to return to the ICS facility to process the order within the same day.

International Order	$[***]/order	Fee applied in addition to any order processing fees.

Warehouse & Distribution Fees

Product Storage	$[***]/pallet (ambient/marketing materials)	Monthly fee for controlled room temperature pallet storage.

Order Processing Fees	$[***]/order	Order is defined as a shipment to a unique address that leaves the distribution center, regardless of the number of cartons or

Fee	Amount	Description

		packages that constitute that shipment and/or the number of inbound requests for said Order.

	$[***]/unit	This fee is in addition to the per order fee for each additional unit that is shipped in the order.

Hazardous Material Fee	$[***]/order	Fee in addition to the per order fee for each order that requires hazardous shipping documentation.

Case Break Fee Bulk Shipment Fee	$[*]/order $[*]/case	Fee in addition to the per order fee for each order shipped at the vial/bottle level. Bulk shipments incur an additional surcharge per case.

Packing Supplies	[***]	Any packing materials that ICS must provide for the AMAG to ship Commercial and Non-Commercial Products.

Freight	[***]	[***]

Finance

Invoice Processing	$[***]/invoice	Fee for sending invoice (electronic or paper) to customer, collection efforts and cash posting.

Credit/Rebill Transactions	$[***]/each	Any AMAG requested credit or rebill transactions keyed in the system.

Credit Verification Reports — Dun & Bradstreet	$[***]/report	Any AMAG requested credit report. Dun & Bradstreet (D&B) typically tracks information for corporate customers.

Credit Verification Reports — Experian	$[***]/report	Any AMAG requested credit report. Experian typically tracks information for individual customers such as physicians.

Returns Management

RGA Initiation	$[***]/RGA	RGA: Returned Goods Authorization. Fee for processing return request from customer and sending the customer an RGA.

Return Processing	$[***]/unit	Receipt of physical return at the distribution center. Fee includes itemizing contents of the return

Return Processing	$[***]/line	Fee applied in addition to Return Processing fee for handling and counting additional lines.

Returns Storage	$[***]/pallet	Monthly fee for controlled room temperature pallet storage.

Contract and Chargeback Management

Chargeback Processing — Manual	$[***]/line	Each SKU is considered a line. If customers cannot send information electronically, they will mail information for manual processing. ICS and Customer must have copies of contracts in order to process chargebacks without manual intervention.

Chargeback Processing — Electronic	$[***]/line	Each SKU is considered a line. Customers will typically send chargebacks electronically according to HDMA standards.

Information Technology and Reporting

Custom Reports	$[***]/hour	Fee for reports created that are not part of the standard reports provided by ICS. Hourly report creation fees assessed for initial report creation but not thereafter for running the same report.

Custom Development Services	$[***]/hour	Fee for customized processes developed at the request of AMAG. Hourly fees will be assessed and approved by AMAG before development work is to begin.

Fee	Amount	Description

Additional Fees

Product Destruction	[***]	Destruction of product per AMAG’s request and instruction.

FedEx/UPS/Postage Expenses	[***]	Freight expenses for shipments of documents or any other shipments related to daily operations on behalf of AMAG.

Pre-Approved Assessorial Labor Charge - Warehouse	$[*]/hour $[*] /hour overtime	This fee will be assessed for work that is completed outside the scope of the agreed upon services outlined in the Services Agreement. AMAG must provide prior approval before assessorial labor takes place.

Pre-Approved Assessorial Labor Charge — Office Staff	$[***]/hour	This fee will be assessed for work that is completed outside the scope of the agreed upon services outlined in the Services Agreement. AMAG must provide prior approval before assessorial labor takes place.

Pre-Approved Assessorial Labor Charge — QC, Management	$[***]/hour	This fee will be assessed for work that is completed outside the scope of the agreed upon services outlined in the Services Agreement. AMAG must provide prior approval before assessorial labor takes place.

ICS Travel	Expenses plus employee time	This is for AMAG requested travel. AMAG must provide prior approval before travel takes place.

SCHEDULE C

ADDITIONAL DEFINITIONS

“Act” means the Federal Food, Drug and Cosmetic Act, Title 21, United States Code, as amended, and the regulations promulgated thereunder.

“Affiliate” means all entities controlling, controlled by or under common control with Company or ICS, as the case may be. The term “control” shall mean the ability to vote fifty percent (50%) or more of the voting securities of any entity or otherwise having the ability to influence and direct the policies and direction of an entity.

“ANDA” means an Abbreviated New Drug Application as defined in and contemplated by the Act.

“Customer” is defined in Agreement Section 1.

“DEA” means the United States Drug Enforcement Administration.

“FDA” means the United States Food and Drug Administration.

“Governmental Authority” means any nation, government, state or other political subdivision, or any entity exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to government.

“ICS Facility” means the facility located at 345 International Blvd., Brooks, KY 40109 or 5360 Capital Court #102, Reno, NV 89502.

“NDA” means a New Drug Application as defined in and contemplated by the Act.

“Person” means any corporation, natural person, the Company, entity, firm, joint venture, partnership, trust, unincorporated organization, or Government Authority.

“Products” is defined in Agreement Recital A.

“Related Parties” means the subsidiaries, parents, Affiliates, officers, directors, employees, independent contractors, representatives, shareholders, trustees and agents of any Person.

“Requirements of Law” means any law (including consumer law), treaty, rule or regulation or a final and binding determination of a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject.

“Services” is defined in Agreement Section 2.

“Taxes” means any and all liabilities, losses, expenses, and costs of any kind whatsoever that are, or are in the nature of taxes, fees, assessments, or other governmental charges, including interest, penalties, fines and additions to tax imposed by any federal, state or local government or taxing authority in the United States on or with respect to: (a) the Agreement or any related agreements or any future amendment, supplement, waiver, or consent requested by the Company or any required by the Agreement with respect to the execution, delivery or performance of any thereof, or the issuance, acquisition or subsequent transfer thereof, (b) the return, acquisition, transfer of title, storage, removal, replacement, substitution, purchase, acceptance, possession, rejection, ownership, delivery, non-delivery, use, operation, sale, abandonment, redelivery or other disposition of any interest in Products or any part thereof, (c) the receipts or earnings arising from any interest in Products or any part thereof, (d) any payment made pursuant to this Agreement or to any Products, or (e) otherwise as a result of or by reason of the transactions contemplated by this Agreement, excluding, however, taxes imposed upon ICS that are

based upon or measured by gross or net income and any franchise Taxes of ICS or any personal property taxes for Products or equipment owned by ICS.

“Term” is defined in Agreement Section 4.1.

SCHEDULE D

COPY OF EXECUTED CONFIDENTIAL AGREEMENT

CONFIDENTIALITY AGREEMENT

This Confidentiality Agreement (the “Agreement”) is made as of the 15th day of October 2007 (the “Effective Date”), by and between AMAG Pharmaceuticals, Inc., a corporation having an office at 125 Cambridge Park Drive, Cambridge, Massachusetts 02140 (“AMAG”) and ICS, Integrated Commercialization Solutions, Inc., a corporation having an office at 3101 Gaylord Parkway, Frisco, Texas 75034 (“ICS”), with AMAG and ICS each referred to herein as a “Party” or together as the “Parties.”

Whereas, ICS desires to receive from AMAG certain confidential information relating to AMAG’s business for the purpose of engaging in discussions regarding a potential business relationship between the Parties (the “Purpose”); and

Whereas, AMAG desires to receive from ICS certain confidential information relating to its business for the Purpose; and

Whereas, the Party disclosing information under this Agreement (the “DISCLOSING PARTY”) or any of their respective officers, employees, Affiliates or consultants (collectively “Representatives”) shall allow the Party receiving such information under this Agreement (the “RECEIVING PARTY”), or its Representatives, to review or obtain the DISCLOSING PARTY’s confidential business and technical information (such information being hereinafter referred to as “CONFIDENTIAL INFORMATION”) only for the Purpose, and otherwise to hold such Confidential Information strictly in confidence pursuant to the terms of this Agreement.

Now, therefore, the Parties hereto agree as follows:

1. For purposes of this Agreement, the term “CONFIDENTIAL INFORMATION” shall include, but not be limited to, written, verbal, visual, electronic or in any other media or manner, and shall include that acquired by observation or otherwise during any site visit at a party’s facility. CONFIDENTIAL INFORMATION includes all technical data, trade secrets, know-how, ideas, research, study results, prototypes, samples, formulas, compounds, methods, plans, specifications, characteristics, raw material data, software, inventions, discoveries, processes, designs, drawings, schematics whether or not patentable, product plans, clinical trials, services, distribution systems, suppliers, markets, business, technology, marketing plans, sales, manufacturing, purchasing and accounting methods, strategy, budgets, contracts, grants, costs, profits, plans for future development, and other information of a similar nature, regardless of whether furnished before, on or after the Effective Date and furnished in any form. CONFIDENTIAL INFORMATION also includes the existence of this Agreement and its terms and the fact that each party is evaluating the other party’s CONFIDENTIAL INFORMATION.

2. In consideration of the Parties’ discussions and any access the RECEIVING PARTY may have to the DISCLOSING PARTY’s CONFIDENTIAL INFORMATION, the RECEIVING PARTY shall:

125 CambridgePark Drive, Cambridge MA 02140 Tel: [617] 498-3300 Fax: [617] 433-3362

AMAG Pharmaceuticals, Inc.

(a) not use such CONFIDENTIAL INFORMATION except for the Purpose;

(b) hold the CONFIDENTIAL INFORMATION in strict confidence and shall protect such CONFIDENTIAL INFORMATION from disclosure and shall use the same degree of care to avoid disclosure of such CONFIDENTIAL INFORMATION as the RECEIVING PARTY employs with respect to its own confidential information of like importance;

(c) not, without the express written permission of the DISCLOSING PARTY, divulge any such CONFIDENTIAL INFORMATION to others, except to persons regularly employed by the RECEIVING PARTY or its Representatives who have a bona fide need to know in connection with pursuing the Purpose provided that the RECEIVING PARTY informs its Representatives of its obligations under this Agreement and uses its best efforts to restrain its Representatives from taking any action that would constitute a breach of this Agreement;

(d) not use for its own benefit or the benefit of its Representatives or any other person or entity, other than the DISCLOSING PARTY any such CONFIDENTIAL INFORMATION; and

(e) not copy, create derivative works of or reverse engineer any such CONFIDENTIAL INFORMATION, except such duplication as is necessary for the Purpose.

3. CONFIDENTIAL INFORMATION shall not include information that the RECEIVING PARTY can, as evidenced by its written records prepared or received prior to the disclosure, show:

(a) is already in the possession of the RECEIVING PARTY, without obligation to keep it confidential, as evidenced by the RECEIVING PARTY’S written records;

(b) is lawfully disclosed to the RECEIVING PARTY by a party other than the DISCLOSING PARTY, provided such information was not, to the knowledge of the RECEIVING PARTY, obtained by such third party directly or indirectly from the DISCLOSING PARTY on a confidential basis;

(c) is independently developed by or for the RECEIVING PARTY without access to or use of the CONFIDENTIAL INFORMATION, as evidenced by the RECEIVING PARTY’S written records; or

(d) is generally known to the public without violation hereof.

4. The RECEIVING PARTY may make disclosures required by an order of a governmental agency, legislative body or court of competent jurisdiction, provided that the RECEIVING PARTY: (i) provides the DISCLOSING PARTY with immediate written notice of such requirement, (ii) cooperates with the DISCLOSING PARTY at the DISCLOSING PARTY’s expense in connection with the DISCLOSING PARTY’s reasonable and lawful actions to obtain confidential treatment for such CONFIDENTIAL INFORMATION, and (iii) limits such disclosure of CONFIDENTIAL INFORMATION to the fullest extent permitted under applicable law.

5. For purposes of this Agreement, “Affiliate” means any corporation, firm, partnership or other entity which controls, is controlled by or is under common control with a party. For purposes of this definition, “control” shall mean the ownership of at least fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest. Only an Affiliate to which

AMAG Pharmaceuticals, Inc.

such CONFIDENTIAL INFORMATION is actually disclosed and received will be bound by the terms of this Agreement.

6. This Agreement will terminate as to the further exchange of CONFIDENTIAL INFORMATION immediately upon the earlier of (a) written notice from one party to the other party of such termination, or (b) one (1) year following the Effective Date. Notwithstanding the foregoing, each party’s obligations of confidentiality and non-use shall continue for a period of seven (7) years from the termination of this Agreement. The RECEIVING PARTY shall treat all CONFIDENTIAL INFORMATION it receives from or concerning the DISCLOSING PARTY prior to the execution of this Agreement as CONFIDENTIAL INFORMATION in accordance with the terms of this Agreement.

7. The RECEIVING PARTY shall be responsible for any disclosure or use of CONFIDENTIAL INFORMATION, or other prohibited activity set forth in Paragraph 2, by any Representative or other person or entity to whom it discloses CONFIDENTIAL INFORMATION. The RECEIVING PARTY shall notify the DISCLOSING PARTY in writing immediately upon becoming aware of the occurrence of any unauthorized release of CONFIDENTIAL INFORMATION or other breach of this Agreement. The RECEIVING PARTY acknowledges and agrees that due to the unique nature of the CONFIDENTIAL INFORMATION there is no adequate remedy at law for any breach of the RECEIVING PARTY’s or its Representatives’ obligations hereunder and that any breach shall result in irreparable harm to the DISCLOSING PARTY. Therefore, upon any such breach, the DISCLOSING PARTY shall be entitled to seek appropriate equitable relief in addition to its remedies at law.

8. The RECEIVING PARTY shall promptly return to the DISCLOSING PARTY, at the DISCLOSING PARTY’s request, all CONFIDENTIAL INFORMATION or other written data and any copies thereof which the RECEIVING PARTY may have made, may have access to, or may possess under the terms of this Agreement. Upon termination of discussions between the Parties or this Agreement, the RECEIVING PARTY shall promptly deliver to the DISCLOSING PARTY all originals, copies, and summaries of documents, materials, and other tangible manifestations of CONFIDENTIAL INFORMATION and any other property of the DISCLOSING PARTY which the RECEIVING PARTY shall have in its possession or under its control, in whatever media, except that a RECEIVING PARTY may retain one (1) copy of CONFIDENTIAL INFORMATION to ensure compliance with its obligations under this Agreement.

9. Nothing contained in this Agreement shall be construed as granting or conveying to the RECEIVING PARTY or its Representatives, by implication, license, estoppel or otherwise, any right, title or interest in or to the CONFIDENTIAL INFORMATION or any inventions, discoveries, improvements or any other intellectual property rights made, conceived or acquired by the DISCLOSING PARTY or any of its affiliates prior to, during or after termination of this Agreement. None of the CONFIDENTIAL INFORMATION which may be disclosed to the RECEIVING PARTY by the DISCLOSING PARTY hereunder shall constitute any representation, warranty, assurance, guarantee, or inducement by the DISCLOSING PARTY as to the non-infringement of patents, trademarks, copyrights or any intellectual property rights or other rights of third parties. Further, disclosure by the DISCLOSING PARTY of CONFIDENTIAL INFORMATION shall not constitute a representation or warranty that the CONFIDENTIAL INFORMATION is accurate, complete, or

adequate for the Purpose contemplated by the RECEIVING PARTY. All CONFIDENTIAL INFORMATION and other written data provided to the RECEIVING PARTY or its Representatives hereunder shall be and remain the property of the DISCLOSING PARTY.

10. No agency or partnership relationship is created by this Agreement. Nothing herein shall obligate the DISCLOSING PARTY to enter into any other business or technical relationship with the RECEIVING PARTY or its Representatives.

11. This Agreement shall be governed by the substantive laws of the State of Delaware, without regard to its conflict of laws principles.

12. In the event that any of the provisions of this Agreement shall be held by a court or other tribunal of competent jurisdiction to be illegal, invalid, or unenforceable, such provisions shall be limited or eliminated only to the minimum extent necessary to preserve the validity of this Agreement. This Agreement shall otherwise remain in full force and effect.

13. In the event any suit or other action is commenced to construe or enforce any provision of this Agreement, the prevailing Party, in addition to all other amounts such Party shall be entitled to receive from the other Party, shall be paid by the other Party a reasonable sum for attorney’s and witness’ fees and costs.

14. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter addressed herein. This Agreement shall not amend, diminish, supplement or otherwise affect any previous agreements, if any, between the Parties with respect to the disclosure or use of information covered by such prior agreements. Any changes to this Agreement must be in writing and signed by the Parties hereto. If the Parties pursue a business venture, they anticipate entering into a definitive agreement that will set forth their respective obligations. Such agreement may incorporate this Agreement by reference, may supplement or modify it or may supersede it.

15. No waiver shall be effective unless it is set forth in a written instrument executed by the Party waiving a breach or default hereunder. No consent to or waiver of any breach or default in the performance of any obligation hereunder shall be deemed or construed to be a consent to or waiver of any other breach or default in the performance of the same or any other obligation hereunder. Failure on the part of any Party to complain of any act or failure to act of any other Party or to declare any other Party in default of any obligation hereunder, irrespective of how long such failure continues shall not constitute a waiver of rights hereunder.

16. The Agreement shall be binding upon, and shall inure to the benefit of, the Parties hereto and their successors and assigns. Each party agrees to be responsible for any breach of this Agreement by its Representatives.

17. The undersigned represent and warrant that they are each authorized to enter into this Agreement and to be bound by the terms hereof.

18. The DISCLOSING PARTY shall not have any liability whatsoever arising from or relating to the RECEIVING PARTY’s or its Representatives’ use of the CONFIDENTIAL INFORMATION or other information disclosed by the DISCLOSING PARTY hereunder.

19. The RECEIVING PARTY shall not disclose to any other person, unless required by law, the fact that CONFIDENTIAL INFORMATION has been made available to the RECEIVING PARTY hereunder, that negotiations are or may be taking place between the Parties or any of the terms, conditions or other facts with respect thereto.

20. The RECEIVING PARTY shall not export, reexport or divert any CONFIDENTIAL INFORMATION for which the government of any country or any governmental agency thereof requires an export license or other governmental approval without first: (i) informing the DISCLOSING PARTY of its desire to export, reexport or divert CONFIDENTIAL INFORMATION; and (ii) obtaining such license or approval.

21. All notices and other communications which are required or permitted under the terms or conditions of this Agreement, shall be in writing and sent by facsimile, overnight courier or registered or certified mail, postage prepaid, to the receiving Party at the address herein or at any other address that the receiving Party may have provided to the sending Party in writing as provided herein. Any notice or other communication delivered by facsimile shall be deemed to have been received the day it is sent, if a business day, and on the next succeeding business day, if not. Any notice or other communication sent by overnight courier shall be deemed to have been received on the day after it is sent, if a business day, and on the next succeeding business day, if not. Any notice or other communication sent by registered or certified mail shall be deemed to have been received on the date received. AMAG’s fax number is (617) 499-3362 and facsimiles to AMAG should be addressed to the attention of General Counsel. ICS’s fax number is 469-365-7580. A copy of any notice provided to ICS shall also be sent to: AmerisourceBergen Specialty Group, Attn: Group Counsel, 3101 Gaylord Parkway, 1N-E186, Frisco, TX 75034.

AMAG Pharmaceuticals, Inc.		ICS

By:	/s/ Scott Mayberry	By:	/s/ Steve Mckinnon

Title	SR. Director, Trade & Pricing	Title:	VP Finance

Date:	October 26, 2007	Date:	10/25/07

EXHIBIT A

CONTINUING GUARANTY AND INDEMNIFICATION AGREEMENT

The undersigned does hereby guarantee to AmerisourceBergen Corporation and each of its subsidiary companies and their successors (the “Indemnitees”) that any food, drugs, devices, cosmetics, or other merchandise (“Products”) now or hereafter shipped or delivered by or on behalf of the undersigned, its subsidiaries, divisions, affiliated companies and representatives (“Guarantors”) to or on the order of any Indemnitee will not be, at the time of such shipment or delivery, adulterated, misbranded, or otherwise prohibited under applicable federal, state and local laws, including applicable provisions of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. §301 et seq., (“FDCA”), and Sections 351 and 361 of the Federal Public Health Service Act, 42 U.S.C.A. §§ 262 and 264, and their implementing regulations (“Applicable Laws”), each as amended and in effect at the time of shipment or delivery of such Products; and such Products are not, at the time of such shipment or delivery, merchandise that may not otherwise be introduced or delivered for introduction into interstate commerce under Applicable Laws, including FDCA section 301 (21 U.S.C.A. §331); and such Products are merchandise which may be legally transported or sold under the provisions of any other applicable federal, state or local law; and the undersigned guarantees further that, in the case of food shipments, only those chemicals or sprays approved by federal, state or local authorities have been used, and any residue in excess of the amount allowed by any such authorities has been removed from such Products.

The undersigned hereby agrees to defend, indemnify and hold the Indemnitees harmless against any and all third party claims, losses, damages, and liabilities whatsoever (and expenses connected therewith, including counsel fees) (collectively, “Claims”), to the extent arising as a result of (a) any actual or asserted violation of Applicable Laws by virtue of which Products made, sold, supplied, or delivered by or on behalf of Guarantors may be alleged or determined to be adulterated, misbranded or otherwise not in full compliance with or in contravention of Applicable Laws, (b) possession, distribution, sale and/or use of, or by reason of the seizure of, any Products of Guarantors, including any prosecution or action whatsoever by any governmental body or agency or by any private party, including claims of bodily injury, death or property damage, (c) any actual or asserted claim that Guarantors’ Products infringe any proprietary or intellectual property rights of any person, including infringement of any trademarks or service names, trade names, trade secrets, inventions, patents or violation of any copyright laws or any other applicable federal, state or local laws, and (d) any actual or asserted claim of negligence or willful misconduct by the Guarantors. [***]. The undersigned’s agreement to defend, indemnify and hold harmless is conditioned on the relevant Indemnitee (i) providing written notice to the undersigned of any Claim for which is it seeking indemnification hereunder in a reasonably prompt manner after becoming aware of such Claim, provided that such requirement is a condition precedent only if failure to provide prompt notice results in actual prejudice to the undersigned in its ability to defend the Claim; (ii) permitting the undersigned to assume full responsibility to investigate, prepare for and defend against any such Claim, except that the Indemnitee may cooperate in the defense at its expense using its own counsel; and (iii); not compromising or settling such Claim without the undersigned’s written consent. The relevant Indemnitee agrees to reasonably cooperate with the undersigned, at the undersigned’s reasonable expense, in the investigation of, preparing for and defense of any such Claim. The undersigned further agrees to maintain Products Liability Insurance of not less than U.S. $ 5,000,000 per occurrence, Combined Single Limit (Bodily Injury and Property Damage)including AmerisourceBergen Corporation and its subsidiary companies and their successors as Additional Insureds, including a Broad Form Vendors Endorsement, with provision for at least 30 days’ prior written notice to the Additional Insureds in the event of cancellation or material reduction of coverage, and upon request promptly submit satisfactory evidence of such insurance to AmerisourceBergen Corporation. All insurance coverage must be with a nationally-recognized, reputable insurance carrier. In combination with significant excess liability insurance, any retained risk must be commercially reasonable and actuarially sound. The undersigned warrants that its assets are sufficient to cover any self-insurance liability it assumes under this Agreement. Provisions in this Continuing Guaranty and Indemnification Agreement are in addition to, and not in lieu of, any terms set forth in any purchase orders accepted by Guarantors or any separate agreement entered into between the Indemnitees and Guarantors. In the event of any conflict between the language of such other documents and the language set forth herein, the language herein shall be controlling.

	AMAG PHARMACEUTICALS, INC.


	By:	/s/ Brian J.G. Pereira

	Name:	Brian J.G. Pereira

	Title:	CEO

	Date:	10/30/08

Revised

6/2/05

EXHIBIT B

CUSTOMER SERVICES

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

1. ICS, as agent of the Company, will develop, operate and maintain an Integrated Access Center (“Access Center”) to manage the comprehensive distribution Services related to Products described herein (“Customer Services”) for the Company. ICS agrees to develop the Access Center and provide the Customer Services for the fees listed in Schedule B.

2. The Access Center includes the following:

2.1 A fully-integrated telecommunications and information system that will capture and manage key data from each Customer requesting information or specific services relating to Products;

2.2 A toll-free Company-dedicated telephone and fax number solely for the Access Center, with all costs being the Company’s responsibility;

2.3 The capability to handle queries about Products related to order processing and account management; and

2.4 The capability to triage queries.

3. ICS, as agent of the Company, will retain, train and manage appropriate staff personnel to operate the Access Center. Responsibilities of Access Center personnel will be to:

3.1 Receive orders via Electronic Data Interchange (“EDI”), facsimile, email, mail or telephone, and (b) be available from 8:00 a.m. to 5:00 p.m. (Central) to receive orders or triage calls to the Company as necessary;

3.2 Receive EDI orders from the Company or its Customers. Upon receipt, ICS will:

3.2.1 Verify that product order file processed from customer and into ICS’ ERP system;

3.2.2 Review EDI order processing error logs and communicate any non-processed orders and reasons to the Company or its Customers; and

3.2.3 Take appropriate action based on direction from the Company to resolve any issues and re-enter orders or order files into the ERP for processing;

3.3 Generate and issue packing slips for the sale of Products sold under this Agreement;

3.4 Manage the process of issuing Product return authorizations and Product destruction authorizations in accordance with the Company’s policies that have been provided to ICS, and coordinate shipment of Product for destruction;

3.5 Set up customer accounts for Customers eligible to purchase from the Company according to parameters provided by the Company, and the Company will periodically supply ICS with its written criteria, as amended from time to time, for all Customer eligibility; and

3.6 At the Company’s prior written request, verify that such Customers meet the Company’s eligibility criteria by:

3.6.1 Credit verification using approved agencies and establishment of credit limits based on the Company’s guidance;

3.6.2 Verification of licenses (including verification of DEA and state controlled substances, regulatory licenses and registrations when filling orders of controlled substances); and

3.6.3 License verification using the NTIS database augmented by a copy of the Customer license if necessary; and

3.7 Obtain Proofs of Deliveries (PODs) for the Company.

4. Order allocations encompass any inbound orders to ICS that need to have original conditions reviewed and/or manipulated as opposed to allowing the order to flow freely through the order process system. All allocated orders shall be filled in accordance with the Company’s written instructions.

5. An order is defined as a shipment to a unique address that leaves the distribution center, regardless of the number of cartons or packages that constitute that shipment and/or the number of inbound requests for such order.

6. The following services are not a part of Customer Services normally provided in the Access Center:

6.1 Product substitution relating to backorder management:

6.2 Stock allocation of Product to the Company’s Customer base:

6.3 Arranging for the re-distribution of Product within the Company’s Customer base; or

6.4 Any services not identified in paragraphs 1 through 3 of this Exhibit B.

EXHIBIT C

WAREHOUSING AND INVENTORY MANAGEMENT SERVICES

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

1. ICS will warehouse and inventory Products at the ICS Facility.

2. ICS will visually inspect each shipment of Product for external container or package damage or loss in transit (based upon records provided to ICS by the Company)

3. ICS will promptly notify the Company upon ICS’s discovery of any damage or loss to Product.

4. ICS will quarantine Product upon receipt and will release Product to salable inventory status within twenty-four (24) hours of written authorization from the Company.

5. ICS will store all Product in compliance with current good manufacturing practice regulations and guidelines and other requirements of the FDA, the U.S. Drug Enforcement Administration (including maintaining required registrations, licenses and other authorizations, observing all DEA security standards and timely filing any necessary ARCOS reports and other DEA forms, including DEA form 222), all other applicable Requirements of Law and in accordance with the Company’s written instructions, if any.

The Company will pay all costs, charges, expenses and import and export duties for delivery and transportation of Product to and from an ICS Facility; provided that ICS shall be responsible for the costs of any transfers of Product from one ICS Facility to another ICS Facility that are initiated by ICS and not requested by the Company.

EXHIBIT D

DISTRIBUTION SERVICES

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

1. Distribution. ICS shall provide the following distribution tasks:

1.1 ICS shall use its best efforts to ensure that Products will be distributed by trained personnel either in corrugated boxes obtained by ICS or in the corrugated boxes in which Products are packaged by the manufacturer.

1.2 ICS shall use it best efforts to ship Products within one (1) business day of receipt of orders by ICS unless otherwise specified under the terms of this Agreement. ICS will not be required to ship within 24 hours if the aggregate of the orders transmitted to ICS on a single day exceed the number of average daily orders received by ICS for the previous 21 business days by 15% of the total of such orders. ICS will ship Product to the destination specified by Customers.

1.3 ICS shall ship Veterans Administration and other government orders direct or to the designated PPV (Preferred Pharmaceutical Vendor).

1.4 ICS shall distribute bulk shipments by a designated carrier using carrier bulk shipment terms.

1.5 ICS shall use its best efforts to ensure that Products are distributed on a FEFO (first expired/first out) basis unless otherwise directed by the Company in writing.

1.6 At the prior written request of the Company, ICS shall deliver Products as a drop ship to Customers and billed to the designated wholesaler.

1.7 ICS shall use its best efforts to ensure that non-EDI orders received by ICS during standard warehouse hours of shipping (currently M-F 8:00 a.m. to 3:00 p.m. Eastern, except holidays) will be filled the same day. ICS shall also use its best efforts to ensure that orders received after this agreed upon cut-off time will be processed no later than the next business day. ICS shall use its best efforts to ensure that EDI orders will be processed within 24 hours of transmission to ICS. ICS will not be obligated to fulfill order within such time periods if orders received by ICS on a single day exceed the number of average daily orders received by ICS for the previous 21 business days by 15% of the total of such orders.

1.8 At the Company’s request, ICS shall provide a “Rush Order” service for specific order or orders to be processed and shipped the same day; provided however, that such services are dependent on ICS’s ability to perform based upon order receipt time, ICS personnel, and transportation carrier availability. Such orders shall be subject to the Company’s payment of the additional fees pursuant to Schedule B.

1.9 At the Company’s request, ICS shall provide “Emergency Order” services, defined as any order received outside of scheduled working hours (currently M-F 8:00 a.m. to 5:00 p.m. Eastern Time) requiring ICS staff to return to the ICS Facility to process the order within the same day. Such Emergency Order services will be subject to additional fees pursuant to Schedule B. ICS shall clearly identify any such orders to the Company at the time of the Company’s request.

2. Inventory. ICS will be responsible for the following inventory tasks:

2.1 ICS shall receive Products from the Company or a Company designee.

2.2 ICS shall ensure that any end of lot discrepancies evidenced by a difference in physical to book inventory as noted during Product distribution will trigger inventory counts and reconciliation by ICS to verify and determine, where possible, the cause for the discrepancy.

2.3 ICS shall provide the Company, at ICS’s expense, one (1) physical product inventory per calendar year and routine cycle counts. ICS shall perform additional physical product inventories upon the Company’ s request and for an additional labor charge. Any such additional physical inventory requested by the Company will be scheduled based upon a written request from the Company and a mutually agreed upon inventory date.

2.4 ICS shall obtain any required packaging materials for distribution the cost of which shall be passed through to the Company pursuant to Schedule B.

2.5 ICS shall pay all labor costs for warehouse personnel providing the Services.

2.6 ICS shall provide tracking for all shipments as required by the Company;

2.7 ICS shall pay for all security costs for the ICS Facility and any other warehouse locations where Products may be stored in accordance with the terms of this Agreement.

2.8 ICS shall process returns within three business days of receipt at the ICS Facility.

2.9 ICS shall ship outdated/damaged Products to a site reasonably designated by the Company for disposal. All transportation and destruction costs will be borne by the Company pursuant to Schedule B.

2.10 ICS shall not responsible for maintaining inventory levels for Product fulfillment.

3. Product Title. The Company will at all times retain title to all of Products under this Agreement.

4. Exclusions. The following services will not be provided by ICS or included as Distribution Services under the terms of this Agreement:

4.1 Processing of Department of Transportation hazardous materials.

4.2 Re-stacking of inbound Products required at the ICS Facility.

4.3 Any other special labeling or packaging required for Products on or for shipments leaving the ICS Facility.

EXHIBIT E

CONTRACT ADMINISTRATION AND CHARGEBACKS PROCESSING

ICS is licensed to utilize CARS/IS software developed by I-many, Inc. to provide contract administration and chargeback processing services. ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

1. Contract Administration. ICS shall enter into the CARS/IS application key demographic information, membership, and pricing arrangements, as provided by the Company, as negotiated between the Company and its key government and non-government contract accounts, including DOD and VA. ICS shall assist the Company in managing information for such accounts, but shall have no liability for the timeliness, accuracy or reliability of the information provided by the Company under this Section.

2. Chargeback Processing. ICS will process debit memo submissions from wholesalers for wholesaler contract sales pricing reconciliation.

2.1 Reconciliation is based upon verification of the submitted wholesaler data against contract administration data. Results of this verification are:

2.1.1 Reconciliation reporting; and

2.1.2 Credit Memo generation.

2.2 Submissions by wholesalers will be either paper or electronic (EDI).

2.2.1 Paper - Processing time for paper submissions will be five (5) business days.

2.2.2 EDI - Processing time for EDI submissions will be three (3) business days.

2.2.3 These times do not apply to new or newly acquired Products for a period of ninety (90) days.

3. Rebates. ICS will provide documentation for rebates to be paid by the Company on a quarterly basis. ICS will also provide the Company with reports, in a format agreed upon by the parties, including pricing information for AMP and FAMP reports, and which otherwise allow the Company to monitor purchasing activity by its key accounts.

EXHIBIT F

ACCOUNTS RECEIVABLE MANAGEMENT AND CASH APPLICATIONS

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

1. ICS will manage all accounts receivable transactions related to the Company managed distribution programs for Product. The Company will establish a lock box at a financial institution of its choosing (the “Financial Institution”). Payments from Customers will be directed to the address of the lock box. The Financial Institution will sweep the lock box daily and deposit payments into the Company’s operating account. The Financial Institution will forward copies of all payment transactions to ICS for cash application purposes. ICS and the Company will jointly determine the following:

1.1 Credit policy

1.2 Class of trade designations

1.3 Terms and conditions

1.4 License requirements

1.5 Dunning process for past due accounts

1.6 Reporting requirements

2. ICS will provide comprehensive accounts receivable management services in conformance with ICS’s standard operating procedures and the Company’s collection policies as they apply to:

2.1 Invoicing (prepare and mail Customer invoices)

2.2 Cash application

2.3 Reconciliation of daily lock box deposits

2.4 Credit hold/release processing

2.5 Change to Customer credit limits per the Company’s approval

Credit reports:

2.5.1. Experian

2.5.2 D & B

2.6 Return authorization credits

2.7 Credit and re-bills

2.8 Reconciliation of accounts receivable to chargebacks

3. ICS will adhere to state and federally mandated good credit and collection practices established jointly by ICS and the Company such as:

3.1 On-line details of calls

3.2 Call list of past due invoices

3.3 Past due reminder letters

3.4 Research and collection of unauthorized deductions

3.5 The Company approved write-offs

EXHIBIT G

FINANCIAL MANAGEMENT SERVICES

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

1. ICS will provide monthly reconciliation of all financial transactions related to the Company managed distribution program for Product as follows:

1.1 Month end close

1.2 Reconciliation of cash, cash discounts and accounts receivable

1.3 Inventory roll over

1.4 Reconciliation of inventory adjustments

1.5 Reconciliation of goods received

1.6 Reconciliation of sales and cost of goods sold

1.7 Reconciliation of returns and cost of goods returns

2. ICS will provide on a monthly basis (or other agreed upon period), the following financial reports:

2.1 Trial Balance

2.2 Cash Application Summary

2.3 Accounts Receivable Reports

2.4 Inventory Reports

2.5 Sales Reports

2.6 Cash Discounts Report

EXHIBIT H

IT SERVICES

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

1. Application Software. ICS shall maintain a license to utilize ERP software developed by International Business Systems to provide Distribution and Financial Services to the Company.

2. Access. ICS shall ensure that access to the DataMart will be available to the Company Monday through Friday from 7:00 a.m. – 7:00 p.m. (Central) except for those holidays recognized by ICS (“Holidays”), a listing of which will be mutually agreed to by the Company and ICS. ICS will contact the Company with reasonable notice of any non-availability of the DataMart due to routine or non-routine system maintenance undertaken by ICS. “DataMart” shall be defined as the repository of information available to ICS regarding Products and related standard reports, including but not limited to daily inventory reports and inventory adjustments.

3. On-Call Support. ICS shall maintain an on-call support line for answering Company questions, receiving requests for correction of errors and providing consulting services relative to the functionality and usage of the DataMart. The support line will be available from 8:30 a.m. – 5:00 p.m. (Central) except for Holidays.

4. Training. ICS shall provide user documentation and training for DataMart through data dictionaries of DataMart; provided, however, that ICS shall have no obligation to provide Crystal Training and licenses to utilize crystal reports to the Company.

5. Back-Ups. ICS shall perform back-up of all the Company transactions at the end of each working day. Such back-up will be performed at a scheduled time each day and will use an IBM utility product to copy all ICS’s the Company data on a media selected by ICS.

6. Electronic Data Interchange. ICS utilizes software developed for EDI X.12 transaction set translation. ICS has implemented for use on behalf of the Company transaction sets that are utilized commonly in the healthcare industry.

7. Data Management and Reporting. ICS shall provide the Company with standard reports as may be reasonably requested by the Company from time to time. ICS has also developed a set of standard data file extracts that cover distribution and financial activity. Frequency for report or data file creation is in part based on functional requirement but may be daily, weekly, monthly or on demand. If customization is needed, the Company and ICS will jointly and reasonably determine the data elements and formats to be included in custom reports, as well as their frequency and data files. Mutually agreed-upon standard reports and files are included in the pricing provided under this Agreement. Additional charges will apply to special reports and data files created based upon hourly programming charges as listed in Schedule B for creation of specialized reports. The Company will be responsible for hardware or software costs directly and for fees listed in Schedule B.

8. Transfer Protocol. ICS will make available to the Company data in the form of electronic files on a detail or summary basis that reflects the operational activity in the Company’s DataMart or CARS/IS environment. The frequency of the data file availability may be event based, daily, weekly or monthly. Certain timing restrictions apply based on type of data. Conversely ICS will receive files from the Company for the purpose of file building, file

maintenance or order processing. The data may be delivered in one of four methods: 1) Cyclone Encrypted or PGP encrypted, 2) Secure Website, 3) E-mail (emergency only) or 4) Electronic Data Interchange:

9. System Disaster Recovery. ICS shall maintain in place disaster-relief plans consisting of disaster recovery procedures, telecommunications switch over during disaster or emergency period, and AS/400 System switch over during disaster or emergency period (collectively, “Disaster Plans”). ICS will maintain the Disaster Plans during the Term.

EXHIBIT I

GOVERNMENT CONTRACTING AND REPORTING SERVICES

ICS shall perform the following Services from the Effective Date of the Commercial Outsourcing Services Agreement between ICS and AMAG throughout the Term of the Agreement:

1. Government Contracting Education Process

1.1. [***]

1.2. [***]

2. Contracting Process

2.1. [***]

2.2. [***]

2.3. [***]

2.3.1. [***]

2.3.2. [***]

2.3.3. [***]

2.3.4. [***]

2.3.5. [***]

2.3.6. [***]

2.4. [***]

3. Calculate and Report Required Pricing

3.1. [***]

3.1.1. [***]

3.2. [***]

3.2.1. [***]

3.2.2. [***]

3.2.3. [***]

3.3. Annual Reporting

3.3.1. [***]

3.3.2. [***]

3.3.3. [***]

4. Process Medicaid Rebates [***]

EX-10.2 3 a09-16940_1ex10d2.htm EX-10.2

Exhibit 10.2

Execution Version

COMMERCIAL PACKAGING SERVICES AGREEMENT

(ferumoxytol IV)

This Agreement is made as of this 29th day of May 2009 (“Effective Date”), by and between AMAG Pharmaceuticals, Inc., a Delaware corporation with a place of business at 100 Hayden Avenue, Lexington, MA 02421 (“AMAG”) and Catalent Pharma Solutions, LLC, a Delaware limited liability company, by and through its Packaging Services group with an office at 3001 Red Lion Road, Philadelphia, Pennsylvania (“Catalent”).

RECITALS

A. Catalent provides packaging and related services to the pharmaceutical industry; and

B. AMAG is a pharmaceutical company that manufactures, markets, and sells pharmaceutical products; and

C. AMAG desires to engage Catalent to provide certain services to AMAG in connection with the packaging of AMAG’s Product (as defined below) and Catalent desires to provide such services pursuant to the terms and conditions set forth in this Agreement.

THEREFORE, in consideration of the mutual covenants, terms and conditions set forth below, the parties agree as follows:

ARTICLE 1
DEFINITIONS

The following terms have the following meanings in this Agreement:

1.1 “Affiliate(s)” means, with respect to AMAG or any third party, any corporation, firm, partnership or other entity that controls, is controlled by or is under common control with such entity; and with respect to Catalent, any corporation, firm, partnership or other entity controlled, directly or indirectly, by Catalent Pharma Solutions, Inc. For purposes of this definition, “control” shall mean the ownership of at least 50% of the voting share capital of entity or any other comparable equity or ownership interest.

1.2 “AMAG-Supplied Materials” means any Product, active pharmaceutical ingredient, bulk drug, drug in primary packaging or other components to be supplied by AMAG to Catalent for Catalent’s provision of the Packaging.

1.3 “Applicable Laws” means all laws, ordinances, rules and regulations within the Territory applicable to the Packaging of the Product or any aspect thereof and the obligations of Catalent or AMAG, as the context requires under this Agreement, including, without limitation, (A) all applicable federal, state and local laws and regulations of each Territory, (B) the U.S.

Federal Food, Drug and Cosmetic Act, and (C) the Good Manufacturing Practices (“GMPs”) promulgated by the Regulatory Authorities, as amended from time to time, as applicable to the Packaging.

1.4 “Batch” means a specific quantity of a Product or Packaged Product, as applicable, comprising a number of units of Product or Packaged Product, as applicable, mutually agreed upon by the parties in writing that (i) is intended to have uniform character and quality within specified limits, and (ii) is processed according to the master batch record during the same cycle of production.

1.5 “Confidential Information” has the meaning set forth in Section 9.2.

1.6 “Contract Year” means the twelve (12) month period commencing on the Effective Date and successive twelve (12) month periods commencing on the anniversary(ies) of the Effective Date during the term of this Agreement.

1.7 “Delivery Date” means the date set forth in the relevant Purchase Order on which Catalent must supply AMAG with Packaged Products, when accepted by Catalent pursuant to Section 4.3.

1.8 “Facility” means Catalent’s facility at 3001 Red Lion Road, Philadelphia, Pennsylvania, or such other facilities as agreed upon in writing by the parties.

1.9 “FDA” means the United States Food and Drug Administration, and any successor agency thereto.

1.10 “Package(d)/Packaging” means the packaging of the Product pursuant to the Specifications.

1.11 “Packaged Product” means the Product once Packaged.

1.12 “Product(s)” means certain ferumoxytol products to be supplied by AMAG in vials, which are more fully described in the Specifications.

1.13 “Purchase Order” means a written document issued by AMAG to Catalent in accordance with Article 4 hereof, authorizing Catalent’s performance of Packaging and other related services pursuant to the terms of this Agreement.

1.14 “Regulatory Authority” means any governmental regulatory authority within a Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

1.15 “Specifications” means the specifications for the Packaging set forth in Exhibit A attached to and incorporated in this Agreement, which shall become a part of this Agreement.

1.16 “Territory” means the United States of America and any other country which the parties agree to add to this definition of Territory in an amendment to this Agreement.

ARTICLE 2
SCOPE

2.1 Catalent agrees to Package the Product at the Facility and AMAG agrees to purchase and pay for the Packaging, in each case in accordance with the terms and conditions set forth in this Agreement.

ARTICLE 3
PRICING AND PAYMENT TERMS

3.1 Price. The fees to be paid to Catalent for the Packaging of the Product shall be as set forth in Exhibit B attached to and incorporated in this Agreement (“Price”).

3.2 Price Adjustment. The Price is subject to adjustment [***], effective [***], upon thirty (30) days written notice from Catalent to AMAG. All price increases for raw materials, labor, utilities and components shall be passed through to AMAG. Upon request, Catalent shall provide reasonable supporting documentation for such increases. However, no such increase will exceed [***] since the last such adjustment.

3.3 Payment. Catalent shall invoice AMAG upon completion of Packaging and AMAG shall make full payment for Packaged Product tendered for delivery in accordance with Section 3.6 (except for amounts subject to any bona fide dispute) in US dollars via wire transfer to Catalent, no later than thirty (30) days from the date of such invoice. If AMAG has not made payment in full of any undisputed amounts by the expiration of such thirty (30) day period, Catalent may, at its option elect to: (i) charge a late payment fee on such unpaid amount equal to one and a half percent (1.5%) per month of such unpaid amount; or (ii) suspend any further deliveries hereunder until such invoice is paid in full.

3.4 Advance Payment. If at any time, AMAG failed to make timely payment in full of all undisputed amounts for two (2) consecutive invoices, Catalent shall have the right to require payment in advance before making any further shipment of the Packaged Products. If AMAG shall fail, within a reasonable time, to make such payment in advance, or if AMAG shall fail to make payment when due, Catalent shall have the right, at its option, to suspend any further deliveries hereunder until such default is corrected, without thereby releasing AMAG from its payment obligations under this Agreement.

3.5 Taxes. Any tax (other than Catalent’s income or franchise taxes), however denominated and measured, imposed upon the Product or upon its manufacture, Packaging, production, storage, inventory, sale, distribution, transportation, delivery, use or consumption and on any AMAG owned tooling and equipment are the responsibility of AMAG, and AMAG shall reimburse Catalent for any such taxes, duties or other expenses paid by Catalent and for which documentation is provided to AMAG.

3.6 Deliveries; Shipping. AMAG will be solely responsible for ensuring that all Product and AMAG-Supplied Materials are delivered to Catalent’s Facility in a timely manner by a carrier obtained by AMAG. All Packaged Product shall be delivered by Catalent to AMAG FCA (Incoterms 2000) the Facility and Catalent will use reasonable efforts to cooperate with the delivery of Product to AMAG, its designee or common carrier. The common carrier shall be selected by AMAG, and title and risk of loss of the Packaged Product shall pass to AMAG upon delivery by Catalent FCA (Incoterms 2000) at the Facility. Catalent will provide AMAG with a copy of the batch record for each Batch of Packaged Product delivered under this Agreement.

3.7 Failure to Take Delivery. If AMAG fails to take delivery of an order of Packaged Product on the scheduled Delivery Date, then Catalent will store such quantities of Packaged Product in accordance with AMAG’s written instructions and will bill AMAG on the first of each month thereafter for reasonable administration and storage costs for such quantities at Catalent’s then-current, standard rates. For any such quantity of undelivered Packaged Product, AMAG agrees that: (A) AMAG has made a fixed commitment to purchase such Packaging and Packaging components, (B) risk of ownership for such Packaged Product shall be borne by AMAG, (C) such Packaged Product shall be on a bill and hold basis for legitimate business purposes; (D) if no delivery date is determined at the time of billing, Catalent shall have the right to ship the Packaged Product to AMAG within two (2) months after billing, and (E) AMAG shall be responsible for any decrease in market value of such Packaged Product that relates to factors and circumstances outside of Catalent’s control. Within five (5) days following a written request from Catalent, AMAG shall provide Catalent with a letter confirming items (A) through (E) of this Section for each Batch of undelivered Packaged Product.

ARTICLE 4
FORECAST, PURCHASE AND SUPPLY

4.1 Purchase and Supply. During the term of this Agreement and subject to Section 4.4 of this Article 4, AMAG shall purchase and Catalent shall supply such quantities of Packaged Product as shall be set forth on Purchase Orders issued by AMAG to Catalent under this Agreement.

4.2 Forecasts. Not later than ten (10) days after the receipt of market approval for a Product to be packaged hereunder, and thereafter on the first day of each calendar month during the term of this Agreement, AMAG shall provide Catalent with a written twelve (12) month rolling forecast (commencing with the immediately following month) of the quantity of Packaged Product which AMAG expects to require from Catalent during each of the next twelve (12) months (“Forecast”). The first three (3) months of the Forecast shall be firm and binding upon the parties (“Firm Commitment”), and the following nine (9) months shall constitute non-binding good faith estimates. Each Forecast shall include (i) the requested Delivery Dates for the Packaged Product within the Firm Commitment, (ii) the quantity of Packaged Product to be delivered and (iii) the lot numbers to be applied to such Packaged Product.

4.3 Purchase Order. AMAG shall submit Purchase Orders for the Firm Commitment at least sixty (60) days prior to the requested Delivery Date. Purchase Order quantities may be requested, which are not equivalent to the Batch sizes specified in Exhibit B, but will be subject to batch change over charges as specified in Exhibit B. Within ten (10) days

of receipt of a Purchase Order, Catalent shall confirm acceptance of such Purchase Order in writing. Catalent may not reject any Purchase Order that does not (i) exceed the then-current Firm-Commitment, (ii) materially shorten the delivery or performance schedule for Packaging, or (iii) materially alter the Specifications or Packaging, and may not unreasonably reject any other Purchase Order. Catalent’s confirmation shall, as applicable, also confirm the Delivery Date or specify alternate Delivery Dates.

4.4 Orders Greater than Forecast. Catalent shall use its commercially reasonable efforts within its existing capacity to supply the quantity of Packaged Product ordered as set forth on the relevant Purchase Order, regardless of the quantity forecast by AMAG subject to the capacity limitations of Catalent’s Packaging equipment and the Facility.

4.5 Amendment of Purchase Orders. Catalent shall use commercially reasonable efforts to accommodate a request by AMAG to amend a Purchase Order to increase or decrease the quantity of Packaged Product to be delivered, provided, however, that the foregoing shall not affect or diminish AMAG’s liability under the Firm Commitment. In the event such amendment causes an increase in Catalent’s cost to perform the Packaging, the Price shall be increased to reflect such increased cost. Catalent shall notify AMAG of such cost increase promptly after Catalent’s receipt from AMAG of the amended Purchase Order, and the increase in such prices shall be effective for the first lot of Product Packaged after the implementation date of such amendment.

4.6 Terms of Agreement Govern. No modification or amendment to this Agreement shall be effected by or result from the receipt, acceptance, signing or acknowledgement of any party’s purchase orders, Catalent quotations, invoices, shipping documents or other business forms containing terms or conditions in addition to or different from the terms and conditions set forth in this Agreement, including but not limited to the payment and shipping terms. The terms of this Agreement shall supersede any provision in any Purchase Order or other document that is in addition to or inconsistent with the terms of this Agreement.

4.7 Changes to Specifications. Should AMAG desire to change the Specifications, AMAG may propose a written amendment to this Agreement reflecting the desired changes. In such case, Catalent will provide AMAG with any proposed changes in the price or the timing of Packaging occasioned by the change in the Specifications. Such amendment will be binding on the parties only if approved by both parties in writing, and will reflect any such changes in the price or the timing of Packaging.

ARTICLE 5
MATERIALS

5.1 Supply of Product. AMAG shall supply to Catalent in accordance with Section 3.6 the Product in quantities sufficient to meet the requirements set forth in accepted Purchase Orders no later than fifteen (15) days before the scheduled Packaging date. Catalent shall use the Product solely and exclusively for Packaging under this Agreement.

5.2 Packaging Components. Catalent shall be responsible for procuring, inspecting and releasing adequate Packaging components as necessary to meet Purchase Orders submitted

by AMAG hereunder, unless otherwise agreed to by the parties in writing. In certain instances, AMAG may require a specific supplier to be used for Packaging components. In such event, the supplier shall be specified in the Specifications, and AMAG shall be responsible for the timeliness, quantity and quality of supply of such Packaging components.

5.3 Reimbursement for Materials. In the event of (A) a Specification change for any reason, (B) termination or expiration of this Agreement, or (C) obsolescence of any Packaging component, AMAG shall bear the cost of any unused Packaging components, plus a markup equal to [***] of Catalent’s [***] cost of such Packaging components for waste, material handling and administration fees, provided that Catalent purchased such Packaging components in quantities consistent with AMAG’s most recent Firm Commitment.

ARTICLE 6
REGULATORY

6.1 Regulatory Authority Inspection. Catalent hereby agrees to advise AMAG promptly of any proposed or unannounced inspection of the Product(s), Packaged Products or Packaging process or procedures by any Regulatory Authority and shall, promptly provide a report of the results of the inspection to AMAG.

6.2 AMAG Technical Representative. During the term of this Agreement, AMAG shall have the right to have one or more technical representatives present in the area of the Facility where the Packaging is being conducted during the Packaging process to (i) review the Packaging process; (ii) review any relevant records in connection with such Packaging process and assess its compliance with cGMP and the Specifications; and (iii) discuss any related issues with Catalent’s management personnel. AMAG’s technical representatives, when on-site (including during any inspection conducted pursuant to Section 6.1), shall comply with Catalent’s rules and regulations.

6.3 Audit; Reporting. AMAG shall have the right during normal business hours, and upon at least ten (10) business days written notice to Catalent, to inspect and audit in a reasonable manner those portions of the Facility in which Packaging is conducted in order to ensure Catalent’s compliance with its obligations under this Agreement. Not later than three (3) business days following the end of each calendar month, Catalent shall deliver to AMAG a written report (or provide AMAG with automated access to such information) in a form and manner reasonably acceptable to the parties, detailing shipping and inventory information for the AMAG Supplied Materials and the Packaged Product to include a summary of inventory held by Catalent as of the close of such calendar month, shipments received and made by Catalent during such month and any Packaged Product held by Catalent on a “bill and hold” basis.

6.4 Product Information. AMAG, at its expense, shall furnish Catalent with all available health, safety and environmental information concerning the Product to be Packaged by Catalent hereunder, including without limitation, material safety data sheets.

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

6.5 Product Loss. Catalent shall store, handle and use the Product and other AMAG Supplied Materials in accordance with this Agreement and the terms of the Quality Agreement and shall use commercially reasonable efforts to minimize waste and loss of the Product and AMAG-Supplied Materials in the Packaging. Subject to the foregoing, Catalent will not be liable for any defects in or losses of Packaged Product in each case to the extent caused by any Product or AMAG-Supplied Materials. Notwithstanding, Catalent and AMAG agree that Catalent may experience certain ordinary and normal manufacturing losses of AMAG-Supplied Materials, Product or Packaged Product in Packaging the Product in accordance with the terms of this Agreement in an amount not to exceed [***] of the total Product Packaged during a Contract Year (the “Acceptable Manufacturing Loss”). Catalent shall provide AMAG with a written report of any Acceptable Manufacturing Loss incurred in connection with the Packaging of each Batch promptly following the delivery of such Batch. AMAG acknowledges that Catalent may reduce the quantity of Packaged Product in a Batch to be delivered pursuant to a Purchase Order issued under this Agreement to the extent of any Acceptable Manufacturing Loss actually incurred for such Batch and to the extent such reduction does not exceed the Acceptable Manufacturing Loss for Batches then-Packaged, and that such reduction will not be a breach of Section 4.1 of this Agreement. Subject to the limitation of Article 12 and any amounts within the Acceptable Manufacturing Loss, Catalent also shall be responsible for the Replacement Cost (as defined in Exhibit D) of Product and AMAG-Supplied Materials to the extent of any damage, loss, theft or destruction while on Catalent’s premises, and not later than thirty (30) days following the end of each Contract Year, Catalent shall provide AMAG with a detailed accounting of any Acceptable Manufacturing Loss actually incurred during such Contract Year together with a payment representing the Replacement Cost for the losses of Product or AMAG-Supplied Materials, if any, that in the aggregate exceed the Acceptable Manufacturing Loss for such Contract Year (any such payment under this Section 6.5, a “Product Loss Payment”).

6.6 Regulatory Compliance. AMAG shall be solely responsible for all permits and licenses required by any Regulatory Authority with respect to the Product and the Packaging under this Agreement, including any product licenses, applications and amendments in connection therewith. Catalent shall be responsible to maintain all permits and licenses required by any Regulatory Authority with respect to the Facility. The parties shall enter into a Quality Agreement in the form attached hereto as Exhibit C contemporaneously with this Agreement. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any commercial matters, including but not limited to allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern. During the term, Catalent shall assist AMAG with all regulatory matters relating to Packaging under this Agreement, at AMAG’s request and at AMAG’s expense. Each party intends and shall cooperate to satisfy all Applicable Laws relating to Packaging under this Agreement.

ARTICLE 7
TESTING; SAMPLES

7.1 Sampling and Testing of Packaged Products. AMAG is responsible for all sampling and testing of the Packaged Products to assure that the Packaged Products are in conformity in all material respects with the Specifications. AMAG, upon receipt of Packaged Products from Catalent, shall have ten (10) days to inspect or otherwise evaluate such Packaged Products. Any Packaged Product that is not rejected by AMAG within thirty (30) days of receipt from Catalent shall be deemed to have been accepted by AMAG. In the event AMAG rejects such delivery, AMAG shall send to Catalent, via overnight delivery service or certified mail, return receipt requested, within three (3) days of discovery of the defect, a notice of rejection along with samples of the rejected Packaged Products. In the event Catalent agrees with AMAG’s rejection of the Packaged Product Catalent, at its expense, shall repackage such Product in accordance with Section 7.2. If Catalent does not agree with AMAG’s determination that the Packaged Products are non-conforming, the rejected Packaged Products shall be submitted to a mutually acceptable third party testing laboratory, which shall determine whether such Products at the time of delivery did conform to the Specifications and were manufactured in accordance with the terms of this Agreement and the Quality Agreement. The parties agree that such testing laboratory’s determination shall be final and the costs of such testing shall be paid by the non-prevailing party.

7.2 Replacement of Defective Packaged Products. Subject to the terms of this Agreement (including Section 7.1 and Article 12), at the written request of AMAG, Catalent shall replace, at its sole expense the Packaging for all defective Packaged Products above the Acceptable Manufacturing Loss that do not comply with the representations and warranties of Catalent set forth in Section 8.1. In the event that Catalent is required to replace such defective Packaged Products, such replacement shall include (i) providing and bearing the cost for all services necessary to replace all defective Packaged Products and (ii) the Packaging components necessary to Package replacement Packaged Product, and (iii) [***] for the production of such replacement Packaged Product. Such replacement Packaged Product shall be delivered by Catalent to AMAG as soon as reasonably possible but in no event later than the delivery date for the next subsequent Batch of Packaged Product to be delivered by Catalent. THE REPLACEMENT BY CATALENT OF ANY DEFECTIVE PACKAGED PRODUCT IN ACCORDANCE WITH THE TERMS OF SECTION 7.2 SHALL BE AMAG’S EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PACKAGED PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED, AS TO SUCH DEFECTIVE PACKAGED PRODUCTS.

ARTICLE 8
REPRESENTATIONS AND WARRANTIES

8.1 Catalent. Catalent represents and warrants to AMAG that:

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

A. The Packaging and Packaged Products provided hereunder at the time of delivery (i) shall comply with the Specifications, the Quality Agreement and Applicable Laws, (ii) will not be adulterated or misbranded within the meaning of the United States Food, Drug and Cosmetic Act, and (iii) not be articles that, under the provisions of such Act, may not be introduced into interstate commerce;

B. Catalent will render the Packaging in accordance with high professional standards, and that the Packaging will be completed in conformance with the terms of this Agreement, the Quality Agreement and any Purchase Order issued hereunder;

C. Catalent will not perform the Packaging using any employee that has been debarred by a Regulatory Authority, or, to the best of its knowledge, is the subject of debarment proceedings by a Regulatory Authority.

8.2 AMAG. AMAG represents and warrants to Catalent that:

A. The Product and any other AMAG-Supplied Materials (i) shall comply with all applicable Specifications, (ii) shall have been produced and delivered in compliance with Applicable Laws and the Quality Agreement, and (iii) in particular, the artwork and label supplied by AMAG shall have been reviewed and approved by AMAG and will comply with Applicable Laws;

B. It has (or shall have, prior to Catalent’s delivery to AMAG) obtained all permits, licenses or authorizations from any applicable Regulatory Authority necessary or required for the sale, marketing or entering into commerce of any Product and Packaged Product;

C. It has all necessary authority and right, title and interest in and to any patents, inventions and developments related to the Products and the Packaging of the Products.

D. Unless otherwise agreed by the parties in writing, AMAG has (1) provided all complete and accurate scientific data, safe handling instructions, health and environmental information and material safety data sheets regarding the Product and regarding the Packaging and AMAG’s written requirements for the Packaging, (2) provided Catalent with complete and accurate information necessary to develop the scope of work, and estimated or fixed costs for the Packaging, (3) reviewed and approved all Specifications, and (4) if applicable, prepared all submissions regarding the Packaging to Regulatory Authorities.

E. AMAG shall comply with all Applicable Laws applicable to AMAG’s performance under this Agreement and to the subsequent transport, use, sale, storage, and disposal of the Packaged Product.

8.3 Mutual. Each party hereby represents and warrants to the other party that:

A. Existence and Power. Such party (1) is duly organized, validly existing and in good standing under the laws of the state in which it is organized, (2) has the power and authority and the legal right to own and operate its property and assets, and to carry on its business as it is now being conducted, and (3) is in compliance with all requirements of

Applicable Laws, except to the extent that any noncompliance would not materially adversely affect such party’s ability to perform its obligations under the Agreement;

B. Authorization and Enforcement of Obligations. Such party (1) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder and (2) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder.

C. Execution and Delivery. This Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms;

D. No Consents. All necessary consents, approvals and authorizations of all Regulatory Authorities and other persons required to be obtained by such party in connection with the Agreement have been obtained; and

E. No Conflict. The execution and delivery of this Agreement and the performance of such party’s obligations hereunder (1) do not conflict with or violate any requirement of Applicable Laws; and (2) do not materially conflict with, or constitute a material default or require any consent under, any contractual obligation of such party.

8.4 Limitations. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 8 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

ARTICLE 9
CONFIDENTIALITY AND NON-USE

9.1 Mutual Obligation; Permitted Disclosures.

A. Catalent and AMAG agree that they shall not use the other party’s Confidential Information (defined below) except as necessary for the receiving party to perform its obligations under this Agreement or disclose the other party’s Confidential Information to any third party without the prior written consent of the other party except as required by law, regulation or court or administrative order; provided, however, that prior to making any such legally required disclosure, the party making such disclosure shall give the other party as much prior notice of the requirement for and contents of such disclosure as is practicable under the circumstances.

B. Notwithstanding the terms of Section 9.1(A), each party may disclose the other party’s Confidential Information to any of its Affiliates that (i) need to know such Confidential Information for the purpose of performing under this Agreement, (ii) are advised of the contents of this Article, and (iii) agree to be bound by the terms of this Article. Further, AMAG may disclose the terms of this Agreement to existing or potential acquirors, merger

candidates, collaborators, or other financial institutions or investors provided that (a) AMAG will ensure that any such recipient is subject to a confidentiality agreement having terms at least as restrictive as those contained herein, and (b) that AMAG remains as guarantor for the recipient’s performance.

C. Notwithstanding the terms of Section 9.1(A), each party may disclose Confidential Information of the other party to the extent such disclosure (i) is required by an order of a court or other government agency, (ii) is required to comply with applicable governmental regulations (including as may be required in any filings made with the U.S. Securities and Exchange Commission or any other securities regulatory authority in any country or jurisdiction), or (iii) is required to comply with the regulations of any securities exchange on which securities of such party are traded; provided, that if a party is required to make any such disclosures of the other party’s Confidential Information it will give reasonable advance notice to the other party sufficient to allow such other party to seek confidential treatment of such Confidential Information.

9.2 Definition. As used in this Agreement, the term “Confidential Information” includes all such information furnished by Catalent or AMAG, or any of their respective representatives or Affiliates, to the other or its representatives or Affiliates, whether furnished before, on or after the date of this Agreement and furnished in any form, including but not limited to written, verbal, visual, electronic or in any other media or manner. Confidential Information includes all proprietary technologies, know-how, trade secrets, discoveries, inventions and any other intellectual property (whether or not patented), analyses, compilations, business or technical information and other materials prepared by either party, or any of their respective representatives, containing or based in whole or in part on any such information furnished by the other party or its representatives. Confidential Information also includes the existence of this Agreement and its terms (which shall be deemed to be the Confidential Information of each party).

9.3 Exclusions. Notwithstanding Section 9.2, Confidential Information does not include information that (A) is or becomes generally available to the public or within the industry to which such information relates other than as a result of a breach of this Agreement, or (B) is already known by the receiving party at the time of disclosure as evidenced by the receiving party’s written records, or (C) becomes available to the receiving party on a non-confidential basis from a source that is entitled to disclose it on a non-confidential basis, or (D) was or is independently developed by or for the receiving party without reference to the Confidential Information, as evidenced by the receiving party’s written records.

9.4 No Implied License. The receiving party shall obtain no right of any kind or license under any patent application or patent by reason of this Agreement. All Confidential Information shall remain the sole property of the party disclosing such information or data.

9.5 Return of Confidential Information. Upon expiration or termination of this Agreement, the receiving party shall, upon request, promptly (but in any case within thirty (30) days) return all such information, including any copies thereof, and cease its use or, at the request of the disclosing party, shall promptly destroy the same and certify such destruction to

the disclosing party; except for a single copy thereof, which may be retained for the sole purpose of determining the scope of the obligations incurred under this Agreement.

9.6 Survival. The obligations of this Article 9 shall terminate five (5) years from the expiration or termination of this Agreement.

ARTICLE 10
TERM AND TERMINATION

10.1 Term. The term of this Agreement, unless sooner terminated as provided below, shall begin on the Effective Date and shall continue in effect for a period of [***] (the “Initial Term”). Thereafter, this Agreement will renew automatically for successive [***] periods (each, a “Renewal Term”), unless either party provides written notice of its desire not to renew not less than [***] prior to the end of the Initial Term or then-current Renewal Term, as applicable.

10.2 Termination. Either party shall have the right to immediately terminate this Agreement if (A) the other party files a petition in bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or suffers or permits the entry of any order adjudicating it to be bankrupt or insolvent and such order is not discharged within thirty (30) days; or (B) if the other party materially breaches any of the provisions of this Agreement, and such breach is not cured within thirty (30) days after the giving of written notice. Additionally, AMAG may terminate this Agreement for any or no reason with ninety (90) days’ prior written notice to Catalent.

10.3 Effect of Termination. Expiration or termination of this Agreement shall be without prejudice to any rights or obligations that accrued to the benefit of either party prior to such expiration or termination. In the event of any termination, Catalent shall promptly return (A) any remaining inventory of materials received from AMAG or AMAG’s suppliers, (B) all packaging components paid for by AMAG, (C) all remaining inventories of the Product; and (D) any other Product or material being stored for AMAG, to AMAG at AMAG’s expense. Catalent shall have no obligation to return the foregoing until all outstanding undisputed invoices sent by Catalent to AMAG have been paid in full. AMAG shall also be required to pay, at the applicable price set forth in the relevant Purchase Order for completed but not yet shipped Packaged Products, Packaged Products in process and Packaged Products shipped but not yet invoiced. In the event AMAG breaches or terminates this Agreement or any Purchase Order, (other than as a result of a breach by Catalent), AMAG shall also be required to pay Catalent for its direct cost of all materials purchased by Catalent for Packaging plus an administrative fee of fifteen percent (15%) of such amount. AMAG shall specify the location in the continental United States to which delivery, at AMAG’s expense, of the foregoing is to be made. Confidential Information exchanged between AMAG and Catalent shall be promptly returned upon termination of the Agreement.

ARTICLE 11
INDEMNIFICATION

11.1 Indemnification by Catalent. Catalent shall indemnify and hold harmless AMAG, its Affiliates, and their respective directors, officers, employees and agents (“AMAG Indemnitees”) from and against any and all suits, claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys’ fees) in connection with any suit, demand or action by any third party (“Losses”) to the extent arising out of or resulting from (A) any breach of its representations, warranties or obligations set forth in this Agreement; (B) any negligence or willful misconduct by Catalent or (C) any actual or alleged infringement or violation of any patent, trade secret, copyright, trademark or other proprietary rights provided by Catalent to perform the Packaging; except, in each case, to the extent that any of the foregoing arises out of or results from any claim for which AMAG is obligated to indemnify any Catalent Indemnitee under Section 11.2.

11.2 Indemnification by AMAG. AMAG shall indemnify and hold harmless Catalent, its Affiliates, and their respective directors, officers, employees and agents (“Catalent Indemnitees”) from and against all Losses to the extent arising out of or resulting from (A) any breach of its representations, warranties or obligations set forth in this Agreement; (B) any manufacture, shipping, sale, promotion, distribution, use of or exposure to the Product, Packaged Product or any materials supplied by AMAG, including, without limitation, product liability or strict liability; (C) AMAG’s exercise of control over the Packaging to the extent that AMAG’s instructions or directions violate Applicable Law; (D) any negligence or willful misconduct by AMAG (including by AMAG’s technical representatives at the Facility); except, in each case, to the extent that any of the foregoing arises out of or results from any claim for which Catalent is obligated to indemnify any AMAG Indemnitee under Section 11.1.

11.3 Indemnification Procedures. All indemnification obligations in this Agreement are conditioned upon the party seeking indemnification: (A) promptly notifying the indemnifying party of any claim or liability of which the party seeking indemnification becomes aware (including a copy of any related complaint, summons, notice or other instrument); provided, however, that failure to provide such notice within a reasonable period of time shall not relieve the indemnifying party of any of its obligations hereunder except to the extent the indemnifying party is prejudiced by such failure; (B) granting the indemnifying party the right, at such indemnifying party’s election, to conduct and control the defense of such claim or proceeding; (C) cooperating with the indemnifying party in the defense of any such claim or liability (at the indemnifying party’s expense); and (D) not compromising or settling any claim or liability without prior written consent of the indemnifying party.

ARTICLE 12
LIMITATION OF LIABILITY

12.1 (a) IN NO EVENT SHALL CATALENT’S LIABILITY FOR ANY CLAIMS, LOSS, DESTRUCTION, DAMAGE, COSTS, OR EXPENSES OF PRODUCT OR OTHER AMAG-SUPPLIED MATERIALS UNDER THIS AGREEMENT (ABOVE THE

ACCEPTABLE MANUFACTURING LOSS) EXCEED [***] DURING ANY [***], PROVIDED THAT THE FOREGOING LIMITATION SHALL NOT APPLY TO ANY SUCH LOSSES ARISING FROM CATALENT’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; AND

(b) IN NO EVENT SHALL CATALENT’S TOTAL LIABILITY UNDER THIS AGREEMENT DURING [***] EXCEED [***] DURING THE [***] PERIOD PRECEDING THE INCIDENT(S) GIVING RISE TO THE APPLICABLE LOSSES, PROVIDED THAT THE FOREGOING LIMITATION SHALL NOT APPLY TO ANY LOSSES ARISING FROM CATALENT’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

12.2 NOTWITHSTANDING SECTION 12.1, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL LOSSES, DAMAGES, COSTS OR EXPENSES OF ANY NATURE WHATSOEVER, INCLUDING WITHOUT LIMITATION, LOSS OF REVENUES, PROFITS, DATA OR USE, WHETHER IN CONTRACT OR TORT OR BASED ON A WARRANTY, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

ARTICLE 13
INSURANCE

13.1 Catalent Insurance. Catalent shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement:

A. Commercial General Liability insurance with a per-occurrence limit of not less than $1,000,000;

B. Products and Completed Operations Liability insurance with a per-occurrence limit of not less than $5,000,000;

C. Workers’ Compensation and Employer’s Liability insurance, with statutory limits for Workers’ Compensation and Employer’s Liability limits of $1,000,000 per accident; and

D. Professional Services Errors & Omissions Liability insurance with per-claim and aggregate limits of not less than $1,000,000.

The parties hereby acknowledge and agree that Catalent may self-insure all or any portion of the required insurance. In the event that any of the required policies of insurance are written on a claims-made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than three (3) years following the expiration or termination of this Agreement. Catalent shall furnish to AMAG a certificate of insurance or

other evidence of the required insurance and additional insured status as soon as practicable after the Effective Date and within thirty (30) days after renewal of such policies. Each insurance policy which is required under this Agreement, other than self-insurance, shall be obtained from an insurance carrier with an A.M. Best rating of at least A-VII.

13.2 AMAG Insurance. AMAG shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement:

A. General Liability Insurance with a per occurrence limit of not less than $1,000,000;

B. Products and Completed Operations Liability Insurance (including coverage for Products used in clinical trials) with a per occurrence limit of not less than $10,000,000; and

C. Workers’ Compensation and Employers Liability insurance, with statutory limits for Workers’ Compensation and Employer’s Liability limits of $1,000,000 per accident.

D. All risk Property Insurance, including transit coverage, in an amount equal to the manufacturing cost, covering AMAG’s property while it is at Catalent’s facilities or in transit to or from Catalent’s facilities.

AMAG shall maintain levels of insurance sufficient to meet its obligations under this Agreement. In the event that any of the required policies of insurance are written on a claims-made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than three (3) years following the expiration or termination of this Agreement. AMAG shall obtain a waiver from any insurance carrier with whom AMAG carries Property Insurance releasing its subrogation rights against Catalent. AMAG shall not have any obligation to first seek reimbursement for any property claim or portion thereof from its insurance carrier for any amount payable by Catalent under this Agreement due to the negligence or willful misconduct of Catalent or material breach by Catalent resulting in a property claim, provided that AMAG will not be entitled to recover from Catalent any loss that could be recovered from AMAG’s Property Insurance policy to the extent of the coverage available. Further, AMAG will refund to Catalent any and all amounts paid by Catalent pursuant to this Agreement which are subsequently recovered under AMAG’s Property Insurance policy. AMAG shall obtain a waiver from any insurance carrier with whom AMAG carries Workers’ Compensation insurance releasing its subrogation rights against Catalent. Catalent Pharma Solutions, Inc. and its Affiliates shall be named as additional insureds under the Products and Completed Operations Liability and General Liability insurance policies with respect to the products and completed operations outlined in this Agreement. AMAG shall furnish certificates of insurance evidencing the required insurance policies and additional insured status to Catalent as soon as practicable after the Effective Date and within thirty (30) days after renewal of such policies. Each insurance policy that is required under this Agreement shall be obtained from an insurance carrier with an A.M. Best rating of at least A-VII. AMAG will provide Catalent prompt advance written notice of cancellation or non-renewal of any of the polices enumerated in (A) through (D) of this Section.

ARTICLE 14
INTELLECTUAL PROPERTY

14.1 Definitions. For the purposes hereof, “AMAG IP” means all intellectual property and embodiments thereof owned by or licensed to AMAG as of the date hereof or developed by AMAG other than in connection with this Agreement. “Catalent IP” means all intellectual property and embodiments thereof owned by or licensed to Catalent as of the date hereof or developed by Catalent other than in connection with this Agreement. “Invention” means any intellectual property developed by either party (whether solely or jointly) during the term of this Agreement in connection with the performance of this Agreement, “API Inventions” means any Invention that related exclusively to the AMAG IP or AMAG’s Product or API, and “Process Inventions” means any Invention, other than an API Invention, that relates exclusively to the Catalent IP or relates to developing, formulating, manufacturing, filling, processing, packaging, analyzing or testing pharmaceutical products generally.

14.2 Catalent IP; Process Inventions. All Catalent IP and Process Inventions shall be owned solely by Catalent. AMAG agrees to assign and does hereby assign to Catalent all of AMAG’s right, title and interest in and to such Process Inventions. Catalent hereby grants to AMAG a [***] license under the Process Inventions to use, sell, offer for sale, and import the Products. No right to the Catalent IP is granted to AMAG under this Agreement.

14.3 Other Inventions. All Inventions other than Process Inventions (including without limitation the API Inventions), if any, shall be owned solely by AMAG. Catalent agrees to assign and does hereby assign to AMAG all of Catalent’s right, title and interest in and to such Inventions. No right to the AMAG IP is granted to Catalent under this Agreement except AMAG hereby grants to Catalent a non-exclusive, non-transferable, royalty-free license to use AMAG IP and any API Inventions solely to the extent necessary for Catalent to perform its obligations under this Agreement at the Facility.

14.4 Further Actions. The parties shall cooperate to achieve the allocation of rights to Inventions anticipated herein and each party shall be solely responsible for costs associated with the protection of its intellectual property.

ARTICLE 15
NOTICE

All notices and other communications hereunder shall be in writing and shall be deemed given: (A) when delivered personally; (B) when delivered by facsimile transmission (receipt verified); (C) when received or refused, if mailed by registered or certified mail (return receipt requested), postage prepaid; or (D) when delivered if sent by express courier service, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof):

To AMAG:		AMAG Pharmaceuticals, Inc.
		100 Hayden Avenue
		Lexington, MA 02421
		Attn: General Counsel
		Facsimile: (617)-812-7661

With a copy to:		AMAG Pharmaceuticals, Inc.
		61 Mooney Street
		Cambridge, MA 02138
		Attn: Material Control Manager
		Facsimile: (617) 649-1614

To Catalent:		Catalent Pharma Solutions, LLC
		Packaging Services
		3001 Red Lion Road
		Philadelphia, PA 19114
		Attn: President, Packaging
		Facsimile: (215) 613-3000

With a copy to:		Catalent Pharma Solutions, LLC
		14 Schoolhouse Road
		Somerset, NJ 08873
		Attn: General Counsel
		Facsimile: (732) 537-6491

ARTICLE 16
MISCELLANEOUS

16.1 Entire Agreement; Amendments. This Agreement, the Exhibits and any amendments thereto constitute the entire understanding between the parties and supersede any contracts, agreements or understanding (oral or written) of the parties with respect to the subject matter hereof. No term of this Agreement may be amended except upon written agreement of both parties, unless otherwise provided in this Agreement.

16.2 Captions. The captions in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement

16.3 Further Assurances. The parties agree to execute, acknowledge and deliver such further instruments and to take all such other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.

16.4 No Waiver. Failure by either party to insist upon strict compliance with any term of this Agreement in any one or more instances shall not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure.

16.5 Severability. If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement shall continue in full force and effect.

16.6 Independent Contractors. The relationship of the parties is that of independent contractors, and neither party shall incur any debts or make any commitments for the other party except to the extent expressly provided in this Agreement. Nothing in this Agreement is intended to create or shall be construed as creating between the parties the relationship of joint ventures, co-partners, employer/employee or principal and agent.

16.7 Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties, their successors and permitted assigns. Neither party may assign this Agreement, in whole or in part, without the prior written consent of the other party, except that either party may, without the other party’s consent, assign this Agreement to an Affiliate or to a successor to substantially all of the business or assets of the assigning company. For the avoidance of doubt, this Agreement may be assigned or transferred in the event of a change in control of a party, whether by merger, stock or asset sale or other transaction.

16.8 Governing Law. This Agreement shall be governed by and construed under the laws of the State of New Jersey, excluding its conflicts of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

16.9 Alternative Dispute Resolution. If any dispute, controversy or disagreement (“Dispute”) arises between the parties, such Dispute shall be presented to the respective presidents or senior executives of Catalent and AMAG for their consideration and resolution. If such parties cannot reach a resolution of the Dispute within twenty (20) days, then such Dispute shall be resolved by binding alternative dispute resolution in accordance with the then existing commercial arbitration rules of CPR Institute for Dispute Resolution, 366 Madison Avenue, New York, NY 10017. Arbitration shall be conducted in the jurisdiction of the defendant party. Notwithstanding anything in this Section 16.9, each party shall have the right to seek injunctive or other equitable relief from a court of competent jurisdiction that may be necessary to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration.

16.10 Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Any photocopy, facsimile or electronic reproduction of the executed Agreement shall constitute an original.

16.11 Publicity. Neither party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other party’s express prior written consent, except as required under Applicable Laws or by any governmental agency or by the rules of any stock exchange on which the securities of the disclosing party are listed, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure.

16.12 Survival. The rights and obligations of the parties shall continue under Articles 9 (Confidentiality), 11 (Indemnification) (including the terms of Article 8 solely as applicable to any claim under Article 11), 12 (Limitation of Liability), 13 (Insurance), to the extent expressly

stated therein, 14 (Intellectual Property), 15 (Notice), 16 (Miscellaneous) and Sections 7.1 (as to Packaged Product delivered prior to such termination date) and 10.3 (Effect of Termination), notwithstanding expiration or termination of this Agreement.

16.13 Guaranty. In consideration of the covenants and rights granted under this Agreement and to induce AMAG to enter into this Agreement, Calatent Pharma Solutions, Inc. (“CPS”) hereby unconditionally guarantees in favor of AMAG the full payment by Catalent of [***] obligations of Catalent [***] due (if any) from Catalent under [***] of this Agreement, subject to the terms and limitations of this Agreement (including Article 12) (the “Guaranty”). The Guaranty shall be enforceable against CPS [***]. CPS understands and acknowledges that its obligations under this Section 16.13 are its absolute and independent obligations as primary obligor. The Guaranty is an absolute and continuing guaranty and shall be binding upon and enforceable against CPS, subject to the underlying defenses (including but not limited to the validity or enforceability of the obligation hereunder or of any term of this Agreement), affirmative defenses, counterclaims, offsets, Limitations of Liability and other rights of Catalent, but without regard to (i) any merger or consolidation of Catalent or any of its Affiliates or CPS into or with any other corporation or entity, (ii) any change in the ownership of CPS; or (iii) any bankruptcy or insolvency of Catalent or its Affiliates.

16.14 Force Majeure. Except as to payments required under this Agreement, neither party shall be liable in damages for, nor shall this Agreement be terminable or cancelable by reason of, any delay or default in such party’s performance hereunder if such default or delay is caused by events beyond such party’s reasonable control including, but not limited to, acts of God, regulation or law or other action or failure to act of any government or agency thereof, war or insurrection, civil commotion, destruction of production facilities or materials by earthquake, fire, flood or storm, labor disturbances, epidemic, or failure of suppliers, public utilities or common carriers; provided however, that the party seeking relief hereunder shall immediately notify the other party of such cause(s) beyond such party’s reasonable control. The party that may invoke this section shall use all reasonable endeavors to reinstate its ongoing obligations to the other. If the cause(s) shall continue unabated for sixty (60) days, then both parties shall meet to discuss and negotiate in good faith what modifications to this Agreement should result from this force majeure.

[SIGNATURE PAGE FOLLOWS]

IN WITNESS WHEREOF, AMAG and Catalent have executed this Agreement as of the date first set forth above.

AMAG PHARMACEUTICALS, INC.		CATALENT PHARMA SOLUTIONS, LLC


By:	/s/David Arkowitz	By:	/s/Benoit Cossart

Name:	David Arkowitz	Name:	Benoit Cossart

Title:	CFO/CBO	Title:	VPAM


Guarantor (solely for purposes of Section 16.13):

CATALENT PHARMA SOLUTIONS, INC.


By:	/s/ David Heyens

Name:	David Heyens

Title:	Group President Packaging Services

[SIGNATURE PAGE TO COMMERCIAL PACKAGING SERVICES AGREEMENT]

AMAG and CATALENT

Comml Packaging of Ferumoxytol

May 29, 2009

Exhibit A

Specifications

1 – Assembly in One (1) Count Cartons:

· Primary

· Place vial on labeler. Apply label and code with lot number and expiration date.

· Pack into WIP container for further packout.

· Secondary

· Place vial on labeler. Apply label and code with lot number and expiration date.

· Hand load one (1) labeled vial and one (1) insert per carton.

· Code carton with lot number and expiration date.

· Pack one hundred (100) cartons per shipper and label shipper

2 – Assembly in Ten (10) Count Cartons:

· Primary

· Place vial on labeler. Apply label and code with lot number and expiration date.

· Pack into WIP container for further packout.

· Secondary

· Hand form carton.

· Assemble egg crate partition and place inside carton.

· Load ten (10) labeled vials and two (2) inserts per carton

· Code carton with lot number and expiration date.

· Pack ten (10) cartons per shipper and label.

3 –Drawings:

· Primary

· All labels and related packaging to conform with cartoon and label drawings attached to this Exhibit A.

Ten (10) pages of drawings to follow.

[Remainder of exhibit contains 10 graphic drawings.]

AMAG and CATALENT

Comml Packaging of Ferumoxytol

May 29, 2009

Exhibit B

Price

Pricing Matrix to Exhibit B — AMAG/Catalent Packing Services Agreement

Product

Anticipated
Standard
Batch Size
of Product

Production
Campaign

Price per
Vial
for
One (1)
Count
Cartons

Batch
change-over
charge
(Applies for
each Batch
used in a
Production
Campaign)

Price per Vial
for
Ten (10)
Count
Cartons

Batch
change-over
charge
(Applies for each
Batch used in a
Production
Campaign)

5ml vials

[***] vials

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

Quoted Separately

$[***]

[***] - [***] vials

Quoted Separately

$[***]

10ml vials

[***] vials

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

[***] - [***] vials

Quoted Separately

$[***]

[***] - [***] vials

Quoted Separately

$[***]

20ml vials

[***] vials

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

$[***]

Not Applicable

[***] - [***] vials

Quoted Separately

$[***]

[***] - [***] vials

Quoted Separately

$[***]

The capitalized terms in this Exhibit B Pricing Exhibit which are not otherwise defined herein shall have their respective meanings set forth in the Commercial Packaging and Services Agreement.

PRICING KEY:

“Batch Size” represents the number of vials within a Batch during one cycle of production.

“Batch Change-Over Charge” represents the charge for clean-up and set-up of the Catalent production room for each new additional Batch processed during a Production Campaign.

“Production Campaign” represents the number of vials from a Batch Size under a Purchase Order.

“Vials” (“vial(s)”) represent the units of Product.

EXAMPLE 1:

Purchase Order A: [***] 5ml Vials — 1 Count Cartons

Product = 5ml Vial

Production Campaign = [***] vials (Comprised of [***] vials from Batch 1 and [***] vials from Batch 2)

Price per Vials @ 1 Count Cartons = $[***]

Batch Change Over Charge:

Batch 1 = Not Applicable

Batch 2 = $[***] (new Batch under same Production Campaign as Batch 1)*

*Note — no further Batch Change Over Charge applicable to Batch 2 unless and until a new Purchase Order is issued for more than [***] vials which would require fulfillment using a new Batch of Product.

Total Charges Purchase Order A:

Production Charge = $[***] ($[***] per x [***])

Change Over Charge = $[***]

Net = $[***]

The above example is presented for illustrative purposes only

EXAMPLE 2:

Purchase Order B: [***] 20ml Vials — 10 Count Cartons

Product = 20ml Vial

Production Campaign = [***] vials (Comprised of 6 separate Batches (1-6) of [***] vials each)

Price per Vials @ 10 Count Cartons = $[***]

Batch Change Over Charge: $[***] (comprised of $[***] x 5 additional Batches under Production Campaign)

Batch 1 = Not Applicable

Batches 2-6 = $[***]/each

Total Charges Purchase Order B:

Production Charge = $[***] ($[***] x [***] vials)

Change Over Charge = $[***]

Net = $[***]

The above example is presented for illustrative purposes only

EXAMPLE 3:

Purchase Order C:

[***]: 5ml Vials — [***] 1 Count Cartons;

10ml Vials [***] 10 Count Cartons

Product = 5ml and 10ml Vials

Production Campaign = [***] vials 5ml 1 count cartons; [***] vials 10ml 10 count cartons

Price per 5ml Vials @ 1 Count Cartons = $[***]

Price per 10ml Vials @ 10 Count Cartons = $[***]

Batch Change Over Charge: $[***] (comprised of $[***] x 1 additional 10ml Batch under Production Campaign)

5ml vials @ 1 count cartons — Batch 1 = Not Applicable

10ml vials @ 10 count cartons —

Batch 1 (1 count) = Not Applicable

Batch 1 (10 count) = Not Applicable

Batch 2 (10 count) = $[***]/each

Total Charges Purchase Order C:

Production Charge = $[***]

$[***] ($[***] x [***] vials)

$[***] ($[***] x [***])

Change Over Charge = $[***]

Net = $[***]

The above example is presented for illustrative purposes only

Additional cost items:

· Validation- No charge if Catalent’s standard validation is used. For custom validation needs, cost will be determined based on customer requirements.

· Project Management and Engineering- Standard Project Management and Engineering will be provided at no charge.

· Dedicated Customer Service team will be provided to manage your account.

· Tooling-additional (if needed). Tooling will be invoiced as follows: 50% upon receipt of order, and balance of 50% at receipt of tooling.

· Note: No tooling needed for Newman Labeler

· Carton prep and plate- $[***] per color per carton

· Carton dies- $[***] each die

· Insert and labels prep and plate-$[***] per color per label

· Label dies- $[***] each label size

· Label Plates - $[***] per label

All amounts are expressed in USD

All pricing set forth above is based on expectations of total annual volume of [***] vials. While there are no guaranteed minimums, if the annual aggregate volume of vials ordered falls below [***] vials at any point the parties will meet to negotiate in good faith any volume-related price adjustments as the parties may mutually agree in writing.

AMAG and CATALENT

Comml Packaging of Ferumoxytol

May 29, 2009

Exhibit C

Date: 06 APR 2009

QUALITY AGREEMENT

Quality Agreement for the Product/Service:

This document constitutes the Quality Agreement (“Agreement”) between Catalent Pharma Solutions, LLC (“Catalent”) and AMAG Pharmaceuticals, Inc. (“Client”) for commercial packing services (“Packaging Services”) as set forth in the Commercial Packaging Services Agreement between Catalent and Client (“Packaging Services Agreement”).

This Agreement defines the individual responsibilities of the Catalent and Client. Specifically, this Agreement defines which party is responsible for the cGMP aspects of packaging, storage and release, as applicable. Furthermore, this Agreement specifies the way in which the batches will be released to ensure compliance with the approved product specifications.

This Agreement is composed of a detailed checklist (see “Responsibilities” list below) of the activities associated with contract packaging, storage, release, distribution and certain other regulatory requirements. Responsibility for each activity is assigned to either Catalent or to Client in the appropriate tick box. In the event of a conflict between any provisions of the Quality Agreement and Packaging Services Agreement, with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of the Packaging Services Agreement and the Quality Agreement with respect to any commercial matters, including but not limited to allocation of risk, liability and financial responsibility, the provisions of this Packaging Services Agreement shall govern. The term of this Agreement shall be concurrent with the term of the Packaging Services Agreement as defined therein.

Catalent Pharma Solutions, LLC
14 Schoolhouse Road
Somerset, NJ 08873
through its Packaging Services Group
located at 3001 Red Lion Road
Philadelphia, PA 19114

AMAG Pharmaceuticals, Inc.
100 Hayden Avenue
Lexington, MA 02421

/s/ Gregory Lane		/s/ Kevin D. Giles
Quality Head		Quality Head

/s/ Dir, Quality Assurance		/s/ Sr. Dir QA
Name and Title		Name and Title

/s/ Gregory Lane 06 APR 09		/s/ Kevin Giles 08 APR 2009
Signature/Date		Signature/Date

Name/Title/Signature/Date		Name/Title/Signature/Date

For purposes of this Quality Agreement, the following definitions shall apply:

A. “API” shall mean the active pharmaceutical ingredient used in the manufacture of the Product as identified in the Specifications.

B. “Applicable Laws” means all laws, ordinances, rules and regulations within the Territory applicable to the Processing of the Product and the obligations of Packaging Services or Customer, as the context requires, including, without limitation, (i) all applicable federal, state and local laws and regulations of each Territory; (ii) the U.S. Federal Food, Drug and Cosmetic Act, and (iii) the “GMPs.” Applicable Laws shall also include all laws, ordinances, rules and regulations applicable in Territories added to this Quality Agreement after the Effective Date of this Agreement, solely to the extent Client or its designee has provided written copies of such laws to Packaging Services prior to Packaging Services’ Processing Product under this Quality Agreement for such additional Territories added after the Effective Date. Copies of all laws shall be in the English language.

C. “Facility” means the Packaging Services facility located at:

3001 Red Lion Road
Philadelphia, PA 19114

D. “FDA” shall mean the United States Food and Drug Administration, and any successor entity thereto.

E. “GMPs” mean the current Good Manufacturing Practices for Finished Pharmaceuticals promulgated by the FDA, as amended from time to time. GMPs shall also include good manufacturing practice regulations promulgated by a Regulatory Authority in a Territory added to this Agreement after the Effective Date of this Agreement, solely to the extent Client or its designee has provided written copies of such regulations to Packaging Services prior to Packaging Services’ Processing Product under this Quality Agreement for such additional Territories added after the Effective Date. Copies of all laws shall be in the English language.

F. “Marketing Application” shall mean an application for marketing authorization which has not yet been approved by the FDA or other Regulatory Authority, including without limitation, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing applications promulgated by Regulatory Authorities.

G. “Marketing Authorizations” shall mean any approved application for marketing authorization including without limitation, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing applications promulgated by Regulatory Authorities.

H. “Process” or “Processing” means the sterile compounding, filling, producing and/or packaging of the Raw Materials into Product in accordance with the Specifications and the terms and conditions set forth in the Packaging Services Agreement and this Quality Agreement.

I. “Product” shall mean the Product identified on the first page of this Quality Agreement.

J. “Regulatory Authority” shall mean the FDA and any other Regulatory Authority within a Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

K. “Specifications” means the procedures, requirements, standards, quality control testing, other data and scope of services set forth in the Packaging Services Agreement.

L. “Standard Operating Procedures” shall mean the standard operating procedures in effect at Catalent which have been approved by Catalent’s Quality Assurance department and which are applicable to the Processing.

M. “Territories” shall mean the Unites States of America and any other country which the parties agree in writing to add to this Quality Agreement from time to time.

	Responsibilities	Catalent	Client
1	COMPLIANCE REQUIREMENT
1.1	Package and hold the product(s) in accordance with all applicable FDA requirements and/or applicable regulatory agencies	X
1.2	Welcome Client audits at mutually agreed upon times of relevant premises, procedures and documentation as well as inspections by Regulatory Authorities	X
1.3	Refrain from subcontracting any of the work to a third party without Client’s prior written approval.	X	X
1.4	Provide information in support of regulatory requirements in accordance with the terms of the applicable Service Agreement.	X
1.5	Notify Client and obtain prior written approval as applicable of any proposed changes to the facilities, equipment, materials or testing that directly impacts the Packaging Services	X	X
1.6	Provide copies of any FDA Form 483, Warning Letter or other official communication from applicable regulatory agencies directly relating to the Packaging Services, Product or the facilities used to package or hold the Product within 5 business days of receipt as well as all subsequent responses	X
1.7	Notify Catalent within 48 hours of any recall and/or confirmed stability failure of the Product that might be attributed to the packaging of the product.		X
1.8	Notify Client within 48 hours of any applicable regulatory agency request for product samples, batch records, notice of inspections for any products supplied to Client and provide Client with daily summary reports of applicable aspects of inspection.	X
1.9	Warrant that it is not debarred under the U.S. Generic Drug Enforcement Act of 1992 and will not knowingly employ or use the services of any individual who is debarred or who has engaged in activities that could lead to being debarred.	X	X

	Responsibilities	Catalent	Client
1.10	Perform and maintain validations relevant to the Packaging Services in accordance with cGMP requirements and Catalent requirements, including process and cleaning validations.	X
1.11	Mutually agree upon and approve all product specific protocols and validations.	X	X
1.12	Conduct operations in compliance with applicable environmental, occupational health and safety laws and regulations.	X
1.13	Assist Client in the investigation and resolution of medical and non-medical product complaints related to the Packaging Services within thirty days.	X
1.14	Notify Client immediately of any requests for information, notices of violations or other communication from any government agency relating to environmental, occupational health and safety compliance, to the extent it directly impacts the Packaging Services.	X
1.15	Notify Client immediately of any incident affecting compliance with environmental, occupational health and safety laws, to the extent they directly impact the Packaging Services.	X
1.16	Pull samples when requested for stability testing as defined in the approved Master Packaging Instructions.	X	X
1.17	Issue and follow-up on FDA Field Alerts (commercial stability testing only). Client will notify Catalent of the decision to initiate a regulatory action prior to notification to the agency whenever possible.		X
1.18	Perform the following responsibilities with regard to Complaints relating to Product or Packaging Services
	Collection and logging	X	X
	Investigation	X	X
	Issue of reports and follow-up corrective action	X	X
	Communicates decision to recall product to Catalent		X
	Responsible for notification to appropriate regulatory agencies		X
	Responsible for management of product recall		X
	Responsible for reconciliation of returned product		X
1.19	Perform the following responsibilities to Regulatory Authorities
	Acts as liaison with regulatory authorities with respect to the product(s).		X
	Maintains relevant safety/hazard and handling data, if applicable.	X	X
	Liaison with health and safety authorities	X	X
	Liaison with environmental protection authorities (pollution prevention)	X	X
2	PACKAGING
2.1	Draft the Master Packaging Instructions (MPI) for product(s) in accordance with the product specifications and/or Client instructions. Catalent will receive Client approval of the MPI from at least one Client Quality representative.	X	X

	Responsibilities	Catalent	Client
2.2	Review and approve executed Packaging Instructions		X
2.3	Utilize specification(s) developed for the product.	X
2.4	Responsible for batch identification system for packaging product.		X
2.5	Responsible for qualification and approval of packaging components.		X
2.6	Responsible for approval of packaging component Suppliers. Responsibility will be assigned based upon who is selecting the supplier for use.	X	X
2.7	Responsible for maintenance of procurement, storage, sampling and testing and release of the packaging components.	X	X
2.8	Responsible for retaining reference samples of labeling, and packaging components, for at least (1) year beyond expiration date assigned to the batch.	X
2.9	Responsible to perform maintenance, qualification and validation of the facility, equipment and processes associated with the packaging of the product.	X
2.10	Responsible to perform sampling and release of packaged product to the Client in accordance with the Product specification and to supply a Certificate of Release to Client.	X
2.11	Responsible for investigation, resolution and documentation of all events not conforming to approved MPI or Specifications. All such investigations shall be recorded and approved within thirty days unless Catalent notifies Client that such investigation will exceed thirty days.	X
2.12	Maintain batch records for the minimum period required by applicable laws and supply a copy of such batch records to Client on at time of release.	X
2.13	Validation batch production and testing records shall be kept for the minimum period required by applicable laws.	X
3	STORAGE AND TRANSPORTATION OF BULK PRODUCT AND WASTE DISPOSAL
3.1	Store bulk product up to time of shipment to Client.	X
3.2	Store bulk product prior to shipment under conditions as defined by the customer and agreed to by Catalent	X
3.3	Arrange for transportation of bulk product to Client or designated third party under appropriate conditions. Catalent will provide carriers unless otherwise designated by the Client	X	X
3.4	Provide for customs formalities and freight forwarding.		X
3.5	Disposal of product waste and any special waste related to the manufacturing and testing process for the product	X
3.6	Insurance for transportation of product		X
4	DOCUMENTATION
4.1	Provide complete batch documentation.	X

		Responsibilities		Catalent		Client
4.2		Reconciliation and accountability for all labeling and specified packaging components as required by the MPI after all critical process steps. Any reconciliation outside pre-established limits must be investigated and a copy of the investigation included in the batch record.		X

AMAG and CATALENT

Comml Packaging of Ferumoxytol

May 29, 2009

Exhibit D

Replacement Costs

The Replacement Cost for Product or AMAG-Supplied Materials (see Sections 6.5, 7.2 or 12.1) will be equal to either: (i) if manufactured by AMAG, AMAG’s direct and indirect manufacturing cost, or (ii) if not manufactured by AMAG, AMAG’s actual acquisition cost. In each case, AMAG will supply supporting documentation for such Replacement Cost.

EX-99.1 4 a09-16940_1ex99d1.htm EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Contacts:

Kristen Galfetti

(617) 498-3362

Carol Miceli

(617) 498-3361

FDA Approves Feraheme™ to Treat Iron Deficiency Anemia in
Adult Chronic Kidney Disease Patients

Product launch expected in the second half of July 2009

LEXINGTON, MA (June 30, 2009) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Feraheme™ (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. The recommended dose of Feraheme is an initial 510 mg IV injection followed by a second 510 mg IV injection three to eight days later. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.

“Feraheme offers patients across the continuum of chronic kidney disease, including patients not on dialysis and patients on dialysis, a new paradigm for the treatment of iron deficiency anemia,” commented Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG. “We are extremely pleased with the FDA’s approval of Feraheme, and we are well prepared and excited to bring this new treatment option to patients and physicians.”

“Iron deficiency anemia is a significant problem in patients with chronic kidney disease and is frequently underdiagnosed and undertreated,(1),(2)” said Bryan Becker, MD, President of the National Kidney Foundation. “We welcome the availability of a new therapy option for chronic kidney disease patients affected by iron deficiency anemia.”

-more-

Clinical Data

Feraheme has been proven to be a safe and effective therapy for treating iron deficiency anemia in adult chronic kidney disease patients. The FDA approval of Feraheme was based on safety and efficacy results from four Phase III studies of patients with chronic kidney disease and iron deficiency anemia. These studies consisted of three open-label, multi-center, randomized safety and efficacy clinical studies and a fourth double-blind, multi-center, randomized, placebo-controlled cross-over safety study. Each of the three pivotal safety and efficacy studies achieved statistical significance in its primary endpoint: the mean change in hemoglobin from baseline at Day 35 after the first dose. Feraheme significantly increased hemoglobin levels as compared to oral iron across the spectrum of chronic kidney disease. Overall, 1,726 subjects were exposed to Feraheme in the development program, including 1,562 patients with all stages of chronic kidney disease.

In accordance with the Pediatric Research Equity Act (PREA) requirement, the Company will conduct two post-marketing studies in the pediatric chronic kidney disease population; one in patients on dialysis and the other in patients not on dialysis. Each study will enroll approximately 75 subjects, collecting pharmacokinetic, safety and efficacy data as compared to oral iron. The Company expects to commence these studies in 2010.

Important Safety Information

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects receiving Feraheme, including three patients with serious hypotensive reactions. Adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects including 0.2% (3/1,726) with serious hypersensitivity reactions. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when treatment of hypersensitivity reactions is readily available. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound, or nuclear imaging.

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in > 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

-more-

Click here to view Feraheme’s product insert which is also available on our website at www.amagpharma.com.

Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a webcast and conference call tomorrow at 8:30 a.m. ET to discuss today’s announcement.

To access the conference call via telephone, please dial (877) 412-6083 from the U.S. or (702) 495-1202 for international callers. A telephone replay will be available from approximately 11:30 a.m. ET on July 1, 2009 through midnight July 3, 2009. To access a replay of the conference call, dial (800) 642-1687 from the U.S. or (706) 645-9291 for international access. The passcode for the live call and the replay is 18122806.

An audio webcast of the call will be available through the Investors section of the Company’s website at www.amagpharma.com. A replay of the webcast will also be available from approximately 10:30 a.m. ET on July 1, 2009, through midnight July 31, 2009.

About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. For additional company and product information please visit www.amagpharma.com.

Feraheme was developed by the Company and is composed of superparamagnetic iron oxide particles with a proprietary semi-synthetic carbohydrate coating.

Feraheme™ is a trademark of AMAG Pharmaceuticals, Inc.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding our anticipated Feraheme availability and launch timing, and our post marketing pediatric studies and the timing thereof, are forward looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward looking statements. Such risks and uncertainties include: (1) uncertainties regarding our ability to manufacture Feraheme, (2) the fact that we have limited sales and marketing expertise, (3) uncertainties regarding our ability to successfully compete in the intravenous iron replacement market, (4) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for Feraheme, if approved, (5) uncertainties relating to our patents and proprietary rights, and (6) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2008. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

(1) Fishbane S, Pollack S, Feldman HI, Joffe MM. Iron indices in chronic kidney disease in the National Health and Nutritional Examination Survey 1988-2004. Clin J Am Soc Nephrol. 2009 Jan;4(1):57-61.

(2) Curtis BM, Barrett BJ, Djurdjev O, Singer J, Levin A. Evaluation and treatment of CKD patients before and at their first nephrologist encounter in Canada. Am J Kidney Dis. 2007 Nov;50(5):733-42

###

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99.1 Press Release dated June 30, 2009.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: June 30, 2009

LIST OF SCHEDULES AND EXHIBITS

Exhibit I

Government Contracting and Reporting Services

DESCRIPTION OF PRODUCTS

SCHEDULE C

CONTINUING GUARANTY AND INDEMNIFICATION AGREEMENT

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

WAREHOUSING AND INVENTORY MANAGEMENT SERVICES

CONTRACT ADMINISTRATION AND CHARGEBACKS PROCESSING

ICS is licensed to utilize CARS/IS software developed by I-many, Inc. to provide contract administration and chargeback processing services. ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

EXHIBIT F

ACCOUNTS RECEIVABLE MANAGEMENT AND CASH APPLICATIONS

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

FINANCIAL MANAGEMENT SERVICES

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement:

EXHIBIT H

ICS shall perform the following Services on and after the Program Launch Date during the Term of the Agreement: