0001104659-12-047042.txt : 20120629 0001104659-12-047042.hdr.sgml : 20120629 20120629172057 ACCESSION NUMBER: 0001104659-12-047042 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20120625 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120629 DATE AS OF CHANGE: 20120629 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMAG PHARMACEUTICALS INC. CENTRAL INDEX KEY: 0000792977 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 042742593 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-10865 FILM NUMBER: 12936856 BUSINESS ADDRESS: STREET 1: 100 HAYDEN AVENUE CITY: LEXINGTON STATE: MA ZIP: 02421 BUSINESS PHONE: 6174983300 MAIL ADDRESS: STREET 1: 100 HAYDEN AVENUE CITY: LEXINGTON STATE: MA ZIP: 02421 FORMER COMPANY: FORMER CONFORMED NAME: ADVANCED MAGNETICS INC DATE OF NAME CHANGE: 19920703 8-K 1 a12-15637_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 25, 2012

AMAG PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

001-10865		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 1.01. Entry into a Material Definitive Agreement.

On June 25, 2012, AMAG Pharmaceuticals, Inc., or the Company, and Takeda Pharmaceutical Company Limited, or Takeda, entered into an Amendment to License, Development and Commercialization Agreement, or the Takeda Amendment, which amended and restated the existing License, Development and Commercialization Agreement and which amendment was deemed effective as of June 22, 2012. The License, Development and Commercialization Agreement with Takeda, dated March 31, 2010, was amended by the Takeda Amendment to, among other things, modify the territories under which Takeda has exclusive rights to develop and commercialize Feraheme® (ferumoxytol) Injection for Intravenous use as a therapeutic agent, amend the timing and pricing arrangements for a Supply Agreement to be entered into between the Company and Takeda in the future, amend the terms related to primary and secondary manufacturing sources for drug substance and drug product of ferumoxytol, amend certain patent related provisions, and change the allocation of certain of the agreed upon milestone payments.

The foregoing description of the Takeda Amendment contained in this Item 1.01 does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the full text of the contract that is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference. Certain portions of this agreement have been omitted from this Current Report on Form 8-K and the version of the agreement attached as Exhibit 10.1 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 2.05. Costs Associated with Exit or Disposal Activities.

On June 25, 2012, the Company announced plans to reduce its workforce by approximately 45 positions, the majority of which are expected to be associated with the Company’s manufacturing and development infrastructure. The Company expects to incur approximately $1.0 million in severance related charges associated with the restructuring, including approximately $0.5 million associated with employees located at the Company’s Cambridge, Massachusetts manufacturing facility, all of which are expected to be recognized during 2012. In addition, the Company announced plans to divest its Cambridge, Massachusetts manufacturing facility. At this time, the Company cannot provide an estimate of the total amount or range of amounts expected to be incurred in connection with its plan to divest its Cambridge, Massachusetts manufacturing facility or an estimate of the amount or range of amounts of the charges that will result in future cash expenditures with respect to such expected divestiture. The Company will file an amended report on Form 8-K under this Item 2.05 within four business days after it makes a

determination of such estimates or ranges of estimates with respect to the expected sale of such property.

A copy of the Company’s press release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.

Item 5.02. Departure of Directors or Principal Officers, Election of Directors, Appointment of Principal Officers; Compensatory Arrangements of Certain Officers.

On June 25, 2012, the Company’s Compensation Committee of the Board of Directors, or the Compensation Committee, approved long-term equity incentive awards in the form of incentive stock options for each of Lee F. Allen, M.D., Ph.D., Executive Vice President of Clinical Development, Scott A. Holmes, Vice President of Finance, Controller and Chief Accounting Officer and Christopher G. White, Chief Business Officer, each, an Executive, and together the Executives. Dr. Allen, Mr. Holmes and Mr. White were granted options to purchase 40,000, 30,000 and 40,000, respectively, shares of common stock under the terms and conditions of the Company’s Second Amended and Restated 2007 Equity Incentive Plan, or the 2007 Plan, at an exercise price of $14.89, the fair market value of a share of common stock on the date of grant. The foregoing options have a seven year term and vest as follows: 25% on the first anniversary of the date of grant and the balance to vest over the following three years on a quarterly basis so that 6.25% of the option award shall vest as of the end of each subsequent three month period following such first anniversary of the date of grant.

In addition, as part of Dr. Allen’s incentive option award discussed above, the Company’s Compensation Committee provided that if a supplemental new drug application, or sNDA, for the broad iron deficiency anemia, or IDA, indication for Feraheme is filed with the U.S. Food and Drug Administration, or the FDA, by the end of 2012, then 50% of the unvested portion of the option award made to Dr. Allen on June 25, 2012 that then remain unexercisable will become exercisable by accelerating the vesting of 50% of the shares with respect to each remaining vesting date. Additionally, if (1) FDA approval of the sNDA for the broad IDA indication for Feraheme is obtained by March 31, 2014 and (2) at the time of such approval Dr. Allen continues to be an employee or a service provider to the Company providing services with respect to the sNDA filing for the broad IDA indication for Feraheme, then all remaining shares subject to this option shall become exercisable.

In addition, as part of Mr. White’s incentive option award discussed above, the Company’s Compensation Committee provided that if Mr. White continues to have primary responsibility over the Company’s business development function and the Company acquires a product approved by the FDA that has generated at least $10 million in revenue during the 12 month period preceding the acquisition, whether by the acquisition of a company, acquisition of the product related assets or through a licensing transaction, then the vesting of 50% of the number of shares subject to the option award made to Mr. White on June 25, 2012 that then remain unexercisable will become exercisable by accelerating the vesting of 50% of the shares with respect to each remaining vesting date. If, after the transaction described in the preceding sentence has closed, and Mr. White continues to have primary responsibility over the Company’s business development function, the Company acquires a second product in a transaction that (1)

would be required to be reported under item 1.01 of Form 8-K as a “material contract” or (2) is otherwise deemed by the Company’s Board of Directors at the time of its approval to be of material importance to the Company’s growth strategy, then all remaining shares subject to this option will become exercisable.

Copies of the Stock Option Agreements expected to be entered into between the Company and each of Dr. Allen and Mr. White with respect to such grants are filed herewith as Exhibits 10.2 and 10.3, respectively, and are incorporated herein by reference. The option granted to Mr. Holmes was issued pursuant to the Company’s previously filed form of Option Agreement.

Item 8.01. Other Events.

On June 22, 2012, the Company announced that the European Commission granted marketing authorization for ferumoxytol, an intravenous iron therapy to treat iron deficiency anemia in adult patients with chronic kidney disease. The marketing authorization follows a positive opinion, issued on April 19, 2012, by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

A copy of the Company’s press release is filed as Exhibit 99.2 to this report and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The Company hereby files the following exhibits:

10.1 Amendment to the License, Development and Commercialization Agreement, dated June 25, 2012, by and between the Company and Takeda Pharmaceutical Company Limited. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission.)

10.2 Option Agreement under the Company’s Second Amended and Restated 2007 Equity Incentive Plan between the Company and Lee F. Allen, dated as of June 25, 2012.

10.3 Option Agreement under the Company’s Second Amended and Restated 2007 Equity Incentive Plan between the Company and Christopher G. White, dated as of June 25, 2012.

99.1 Press Release dated June 25, 2012.

99.2 Press Release dated June 22, 2012.

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/ Frank E. Thomas
	Executive Vice President and Chief Operating Officer


	Date: June 29, 2012

EXHIBIT INDEX

Exhibit Number		Description

10.1		Amendment to the License, Development and Commercialization Agreement, dated June 25, 2012, by and between the Company and Takeda Pharmaceutical Company Limited. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission.)

10.2		Option Agreement under the Company’s Second Amended and Restated 2007 Equity Incentive Plan between the Company and Lee F. Allen, dated as of June 25, 2012.

10.3		Option Agreement under the Company’s Second Amended and Restated 2007 Equity Incentive Plan between the Company and Christopher G. White, dated as of June 25, 2012.

99.1		Press Release dated June 25, 2012.

99.2		Press Release dated June 22, 2012.

EX-10.1 2 a12-15637_1ex10d1.htm EX-10.1

Exhibit 10.1

Execution Copy

AMENDMENT TO LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This AMENDMENT TO THE LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Amendment”) is effective as of June 22, 2012 (the “Amendment Effective Date”) by and between AMAG PHARMACEUTICALS, INC., a Delaware corporation with its principal place of business at 100 Hayden Ave, Lexington, MA 02421, USA (“AMAG”), and TAKEDA PHARMACEUTICAL COMPANY LIMITED, a company incorporated under the laws of Japan, with its principal place of business at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka, 540-8645, Japan (“Takeda”). AMAG and Takeda may be referred to herein individually as a “Party” or collectively as the “Parties”.

RECITALS

A. AMAG and Takeda are parties to that certain License, Development and Commercialization Agreement, dated March 31, 2010, (the “Agreement”) pursuant to which AMAG granted Takeda certain rights to the Product in the Licensed Territory and agreed to supply the Product to Takeda under a commercial supply agreement to be negotiated.

B. The Parties now desire to amend certain terms of the Agreement in accordance with Section 16.1 thereof.

NOW, THEREFORE, AMAG and Takeda agree as follows:

1. AMENDMENT OF THE AGREEMENT

AMAG and Takeda hereby agree to amend the terms of the Agreement as provided below, effective as of the Amendment Effective Date. Where the Agreement is not explicitly amended, the terms of the Agreement will remain in force. Capitalized terms used in this Amendment that are not otherwise defined herein shall have the meanings such terms are given in the Agreement.

1.1 Supply Working Group. Within [***] after the Amendment Effective Date, the Supply Working Group established by the JSC pursuant to Section 3.1(a)(iv) of the Agreement shall meet either in person or by teleconference (as mutually agreed) to revise its charter with respect to membership, meeting frequency, global supply planning, manufacturing process harmonization, safety stock and other matters related to the Product as proposed by the members. Within [***] after the Amendment Effective Date and then at least every [***] thereafter, AMAG shall provide the members of the Supply Working Group with AMAG’s good faith estimate of AMAG’s direct materials cost [***].

1.2 Amendments to Definitions.

(a) Section 1.14 of the Agreement (definition of CIS) is hereby deleted in its entirety.

[***] 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.

(b) Effective as of March 31, 2012, Section 1.63 of the Agreement is hereby amended to read in its entirety as follows:

1.63 “Licensed Territory” means Europe, CEE, Asia-Pacific and the countries shown in Part IV of Exhibit B-1 attached hereto, but excluding any country or territory in which this Agreement has been terminated under Article 13.

1.108 “Required Site” has the meaning set forth in Section 7.3(a).

(d) A new section 1.109 is hereby added to the Agreement to read in its entirety as follows:

1.109 “Target Approval Date” means [***], or as otherwise provided in Section 7.3(d), in each case as adjusted pursuant to Section 7.3(b).

(e) A new section 1.110 is hereby added to the Agreement to read in its entirety as follows:

1.110 “Harmonization” with a correlative meaning for “Harmonized,” means [***].

1.3 Amendments to Supply Terms.

(a) Within [***] days after the Amendment Effective Date, the Parties shall enter into a supply agreement and quality agreement governing the supply of Product by AMAG to Takeda in unlabeled finished form for clinical and commercial use, as well as the quality control and quality assurance procedures related to such supply (collectively the “Supply Agreement”) and any other operational agreements and procedures as deemed necessary by the Parties for such supply of the Product. The terms of such Supply Agreement shall be negotiated diligently and in good faith by the Parties in accordance with the terms of Schedule 7.2.

(b) Section 7.2 of the Agreement is hereby deleted in its entirety.

7.3 Primary and Second Source.

(a) AMAG will maintain a primary source of supply, either itself or through a DSS, for each of drug substance and drug product (the “Primary Supply Chain”). As of the Amendment Effective Date, the Primary Supply Chain [***] for drug product, except that AMAG may supply Product produced at [***] pursuant to sub-section (f) below. As

soon as reasonably practicable after the Amendment Effective Date, Takeda shall file all regulatory materials with Health Canada necessary to obtain, and will use Commercially Reasonable Efforts to obtain and maintain, approval from Health Canada of the Primary Supply Chain in effect as of the Amendment Effective Date, and [***] as of the Amendment Effective Date, [***] Product for sale in the Canada. [***] As soon as reasonably practicable after the Amendment Effective Date, Takeda shall file all regulatory materials with SwissMedic necessary to obtain, and will use Commercially Reasonable Efforts to obtain and maintain, at [***], approval from SwissMedic of the Primary Supply Chain in effect as of the Amendment Effective Date, and [***] as of the Amendment Effective Date, for use in manufacturing Product for sale in Switzerland. [***]

(b) In addition to the Primary Supply Chain, AMAG shall use best efforts to establish a Designated Second Source Supplier for the Licensed Territory for each of drug substance and drug product for the Product and to obtain from each applicable Regulatory Authority in the Licensed Territory by the Target Approval Date all approvals necessary for each such DSS to manufacture the Product for commercial and clinical use in the Licensed Territory (each such DSS, a “Required Site”). Each Required Site shall [***] as of the Amendment Effective Date unless the Parties agree that a Required Site will [***] [***] Following each such approval, AMAG shall use Commercially Reasonable Efforts to cause each Required Site to maintain such approvals, and will be solely responsible for all out-of-pocket costs incurred by AMAG in connection therewith. [***]

(c) In connection with AMAG’s efforts under Section 7.3(b), Takeda shall use best efforts to prepare and submit to the applicable Regulatory Authorities in the Licensed Territory, using materials provided by AMAG, all Regulatory Materials, and to take all other actions reasonably requested by AMAG, in each case that are necessary to obtain from each such Regulatory Authority by the Target Approval Date all approvals necessary for each such Required Site to manufacture the Product for commercial and clinical use in the Licensed Territory. Following each such approval, Takeda shall use Commercially Reasonable Efforts to take such actions reasonably requested by AMAG and that are necessary to maintain such approvals. [***]

(d) If the Parties agree, which agreement shall not be unreasonably withheld, that a Required Site established by AMAG pursuant to Section 7.3(b) will develop a manufacturing process for the Product [***] as of the Amendment Effective Date, or will implement specifications for the Product [***] as of the Amendment Effective Date, then the Target Approval Date will be [***], as may be adjusted pursuant to Section 7.3(b).

(e) AMAG shall provide Takeda with the materials, information and other assistance reasonably requested by Takeda for Takeda to obtain as soon as practicable

approval from Health Canada and SwissMedic to [***] as of the Amendment Effective Date.

(f) Within [***] Days after the Amendment Effective Date, AMAG will establish a [***] (which amount will be reduced as Product is supplied to Takeda) of Product and will store and maintain such safety stock in accordance with the Product specifications and applicable Laws, including all requirements for storage imposed by Health Canada. [***] Notwithstanding this Section 7.3(f), the safety stock provisions of the Supply Agreement shall apply with respect to [***] beginning on the [***] after the Primary Supply Chain is approved by Health Canada. To the extent of any conflict between the terms of the Supply Agreement and the supply terms in this Agreement, the Supply Agreement will control.

(g) For the avoidance of doubt, the provisions of Section 7.3(b) and 7.3(d) that are contingent upon mutual agreement of the Parties [***].

1.4 Amendments to Milestone Payments. Section 8.2 of the Agreement is hereby amended to read in its entirety as follows:

8.2 Development Milestone Payments. Takeda shall make milestone payments to AMAG based on achievement of certain milestone events for the Product as set forth in this Section 8.2, in partial consideration for the prior and future cost of developing the Product. Takeda shall pay to AMAG the amounts set forth below within [***] after receipt by Takeda of AMAG’s invoice following the achievement of the corresponding milestone event. Except with respect to Milestone Event 6, [***] each milestone payment by Takeda to AMAG hereunder shall be payable only once, regardless of the number of times achieved by the Product. Each such payment is nonrefundable and non-creditable against any other payments due hereunder.

[]*	[]*
1. Upon the receipt of the first approval by the EMA of an MAA for the Product for an Indication in the Field: If such Indication is any Indication other than the IDA Indication:	$	15,000,000

[***]	[***]
[***]	[***]

[]*	[]*
3. Upon the First Commercial Sale of the Product in Europe for any Indication.	$	15,000,000
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]

[***]

1.5 Amendments to Patent Term Extension Provisions. Section 9.4 of the Agreement is hereby amended to read in its entirety as follows:

9.4 Patent Term Extensions in the Licensed Territory. The JSC will discuss and recommend for which of the Patents within the AMAG Patents and Takeda Patents in the Licensed Territory the Parties should seek Patent Term Extensions in the Licensed Territory. Notwithstanding the preceding sentence, in each of the EU-5 countries, AMAG shall apply for SPC for AMAG Patent [***] within [***] days after the first approval of an MAA for the Product by the EMA, in accordance with applicable Laws. For all other countries in the Licensed Territory, AMAG shall apply for Patent Term Extension for the applicable AMAG Patents covering the Product in accordance with applicable Laws within [***] days after Takeda’s written request. Except as required by applicable Laws, AMAG shall not withdraw any application for Patent Term Extension with respect to the Product after submission thereof without the prior written consent of Takeda. Any withdrawal of an application for Patent Term Extension will be deemed to be a rejection of such Patent Term Extension by the governmental agency having the authority to approve such Patent Term Extension. In the event that Patent Term Extension is subsequently approved upon re-application by AMAG, Takeda shall repay any amounts withheld from AMAG pursuant to 8.4(b) using the same payment schedule applicable to the period of time from initial rejection to final approval. Takeda shall cooperate fully with AMAG in making such filings or actions, for example and without limitation, by making available all required regulatory data and information and executing any required authorizations to apply for such Patent Term Extension. All expenses incurred in connection with activities of AMAG with respect to the AMAG

Patent(s) for which AMAG files for Patent Term Extensions pursuant to this Section 9.4 shall be entirely borne by AMAG, except that Takeda shall reimburse all of AMAG’s reasonable, documented out-of-pocket costs in connection with any Patent Term Extensions outside the EU-5 that Takeda requests AMAG to file.

1.6 Amendments to Schedules and Exhibits.

(a) Exhibit B of the Agreement is hereby replaced with Exhibit B-1 attached to this Amendment.

(b) Section 1 under the heading “Price/Payment” in Schedule 7.2 of the Agreement is hereby amended to read in its entirety as follows:

Price/Payment

1) The purchase price for commercial and clinical supply shall be [***]

[***]

Beginning in [***], and [***] thereafter during the remainder of the Term prior to Harmonization, AMAG shall provide Takeda with a reasonably detailed analysis sufficient to determine whether Harmonization [***]. Such annual analysis (each an “Annual Analysis”) will be based [***].

If the Annual Analysis due in [***] demonstrates that Harmonization beginning on the [***] that is [***] months after the month in which such Annual Analysis was due will [***] (“Demonstration”), then AMAG shall file with the FDA, within [***] days after the month in which such Annual Analysis was due, all regulatory materials necessary to obtain, and upon such filing, will use Commercially Reasonable Efforts to obtain and maintain, approval of Harmonization by the FDA as soon as practicable. If following Demonstration AMAG does not make such filing within such [***] day period or, upon making such filing, does not use Commercially Reasonable Efforts to obtain and maintain, approval of Harmonization by the FDA as soon as practicable, then notwithstanding any other provision of this Section 1, [***].

If Harmonization has not yet been implemented and the Annual Analysis due in December 2015 or any Annual Analysis thereafter during the Term demonstrates that Harmonization beginning on the [***] that is [***] months after the month in which such Annual Analysis was due will result in a Material Reduction (“Second Demonstration”), then AMAG shall file with the FDA, within [***] days after the month in which such Annual Analysis was due, all regulatory materials necessary to obtain, and upon such filing will use Commercially Reasonable Efforts to obtain and maintain, approval of Harmonization by the FDA as soon as practicable. If following Second Demonstration AMAG does not make such filing within such [***] day period or, upon making such

filing, does not use Commercially Reasonable Efforts to obtain and maintain, approval of Harmonization by the FDA as soon as practicable, then notwithstanding any other provision of this Section 1, [***]

For the avoidance of doubt, notwithstanding any other provision of this Section 1, upon Harmonization by AMAG, [***] (ii) no further Annual Analyses will be due.

[***]

(c) The last sentence of Section 1 under the heading “Manufacture and Quality Control” in Schedule 7.2 of the Agreement is hereby amended to read in its entirety as follows:

The Product shall be manufactured according to specifications for the Product set forth in the Supply Agreement (“Specifications”).

(d) The last sentence of Section 2 under the heading “Manufacture and Quality Control” in Schedule 7.2 of the Agreement is hereby amended to read in its entirety as follows:

AMAG shall not make any material changes to the Specifications or to the materials, equipment, process or procedures used to manufacture Product for the Licensed Territory (a “Process Change”) without Takeda’s prior written consent, which consent shall not be unreasonably withheld or delayed. For clarity, a material change includes any change that must be approved by a Regulatory Authority. Takeda shall notify AMAG of its consent or non-consent to a proposed Process Change within [***] days after receipt of AMAG’s written notice of such proposed Process Change; provided, however, that Takeda shall be deemed not to have consented to such change if Takeda fails to provide a response to AMAG within such [***] day period. If, after the Amendment Effective Date, Takeda requests a Process Change, AMAG shall use Commercially Reasonable Efforts to accommodate such Process Change and, if AMAG implements such Process Change, shall use Commercially Reasonable Efforts to do so in a cost-effective manner. If as a result of such change, the Fully Burdened Manufacturing Cost [***] then [***]. With respect to any expenses incurred by AMAG in connection with such Process Change that are not included in the Fully Burdened Manufacturing Cost, (i) capital equipment expenditures will be shared as provided in Section 6 under the heading “Price/Payment” and (ii) [***].

If, after the Amendment Effective Date, the Parties agree to make any Process Change, other than a Process Change requested by Takeda or required to obtain or maintain Regulatory Approval for the Product in the Licensed Territory (which is addressed in the paragraph above), then AMAG shall use Commercially Reasonable Efforts to implement such Process Change in a cost-effective manner. If as a result of such change, the Fully

Burdened Manufacturing Cost [***] then [***]. With respect to any expenses incurred by AMAG in connection with such Process Change that are not included in the Fully Burdened Manufacturing Cost, (i) capital equipment expenditures will be shared as provided in Section 6 under the heading “Price/Payment” and (ii) with respect to the other expenses (such as for process development and validation of testing methods), the Parties shall reasonably allocate between the Parties such expenses to the Licensed Territory and to outside the Licensed Territory, based on Takeda’s most recent forecast volumes and AMAG’s then-current estimate of Product volumes for outside the Licensed Territory, in each case for the subsequent [***] months.

(e) Sections 1 and 2 under the heading “Second Source / Safety Stock” in Schedule 7.2 of the Agreement are hereby deleted.

(f) Schedule 7.3 of the Agreement is hereby deleted.

2. MISCELLANEOUS

2.1 Full Force and Effect. This Amendment amends the terms of the Agreement and is deemed incorporated into the Agreement. The provisions of the Agreement, as amended by this Amendment, remain in full force and effect.

2.2 Entire Agreement. The Agreement and this Amendment constitute the entire agreement, both written and oral, between the Parties with respect to the subject matter hereof, and any and all prior agreements with respect to the subject matter hereof, either written or oral, expressed or implied, are superseded hereby, merged and canceled, and are null and void and of no effect.

2.3 Counterparts. This Amendment may be executed in one or more counterparts, each of which will be an original and all of which together will constitute one instrument.

IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.

TAKEDA PHARMACEUTICAL COMPANY LIMITED		AMAG PHARMACEUTICALS, INC.


By:	/s/ Frank Morich	By:	/s/ William Heiden

Name:	Frank Morich	Name:	William Heiden

Title:	Member of the Board Chief Commercial Officer	Title:	President and Chief Executive Officer

EXHIBIT B-1
LICENSED TERRITORY

Part I (Europe)

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom, Norway, Iceland and Switzerland

Part II (Asia Pacific)

Australia, Brunei, Cambodia, Fiji, Indonesia, Kiribati, North Korea, South Korea, Laos, Malaysia, Marshall Islands, Federated States of Micronesia, Nauru, New Zealand, Palau, Papua New Guinea, Philippines, Samoa, Singapore, Solomon Islands, Thailand, Timor-Leste, Tonga, Tuvalu, Vanuatu, Vietnam, American Samoa, Guam and Northern Mariana Islands

Part III (CEE)

Albania, Croatia, Bosnia and Herzegovina, Serbia, Montenegro and Macedonia

Party IV

Canada, India and Turkey

B-1

EX-10.2 3 a12-15637_1ex10d2.htm EX-10.2

Exhibit 10.2

Stock Option Grant

1. Grant of Option

AMAG Pharmaceuticals, Inc., a Delaware corporation (the “Company”), hereby grants to Lee F. Allen, M.D., Ph.D. (the “Recipient”), an option to purchase 40,000 shares of Common Stock, $.01 par value per share, of the Company as hereinafter set forth (the “Option”), pursuant and subject to the terms and provisions of the Company’s Second Amended and Restated 2007 Equity Incentive Plan (the “Plan”). The date of grant of this Option is June 25, 2012.

All terms which are defined in the Plan shall have the same meanings herein.

2. Vesting of Option

This Option shall be exercisable in cumulative installments on each of the following dates, as follows:

Date Exercisable		Number of Shares Exercisable

On date of grant		0

On June 25, 2013		10,000

On September 25, 2013		12,500

On December 25, 2013		15,000

On March 25, 2014		17,500

On June 25, 2014		20,000

On September 25, 2014		22,500

On December 25, 2014		25,000

On March 25, 2015		27,500

On June 25, 2015		30,000

On September 25, 2015		32,500

On December 25, 2015		35,000

On March 25, 2016		37,500

On June 25, 2016		40,000

Stock Option Agreement

Except as set forth in this paragraph, no additional shares shall vest and become exercisable between each of the vesting dates set forth above. In the event that the Supplemental New Drug Application (sNDA) for the broad iron deficiency anemia (“IDA”) indication for Feraheme is filed with the U.S. Food and Drug Administration (“FDA”) by the end of 2012 and Dr. Allen remains employed by the Company as of the filing date, then the vesting of 50% of the number of shares subject to the Option that then remain unexercisable shall become exercisable by accelerating the vesting of 50% of the shares with respect to each remaining vesting date. In the event that (1) FDA approval of the sNDA for the broad IDA indication for Feraheme is obtained by March 31, 2014 and (2) at the time of FDA approval, Dr. Allen continues to be an employee or a service provider to the Company providing services with respect to the sNDA filing for the broad IDA indication for Feraheme, then all shares subject to the Option that then remain unexercisable shall become exercisable.

3. Term of Option

Unless terminated earlier as provided in Section 6 below, this Option shall terminate in seven (7) years on June 25, 2019.

4. Exercise Price

The exercise price of this Option shall be fourteen dollars and eighty-nine cents ($14.89) per share.

5. Exercise and Payment

(a) Method of Payment. This Option shall be exercisable by delivery to the Company of written notice of exercise, specifying the number of shares for which this Option is being exercised (subject to Section 2 hereof), together with (i) payment to the Company for the total exercise price thereof in cash, by check, (ii) subject to the Company’s approval, by Common Stock of the Company already owned by the Recipient, (iii) delivery of an irrevocable and unconditional undertaking by a creditworthy broker to deliver promptly to the Company sufficient funds to pay the exercise price, (iv) delivery by the Recipient to the Company of a copy of irrevocable and unconditional instructions to a creditworthy broker to deliver promptly to the Company cash or a check sufficient to pay the exercise price, or (v) by some combination thereof; provided that methods (iii) and (iv) shall only be permissible if the Company’s Common Stock is listed on the Nasdaq Global Market or other national securities exchange at such time.

(b) Valuation of Shares Tendered in Payment of Purchase Price. For the purposes hereof, the fair market value of any share of the Company’s Common Stock which may be delivered to the Company in exercise of this Option shall be determined in good faith by the Board of Directors of the Company, or, in the absence of such determination, shall be equal to the closing price of a share of the Company’s Common Stock as reported on the

Nasdaq Global Market (or other national securities exchange or automated marketplace upon which the Company’s Common Stock is then traded) on the date of exercise of this Option.

(c) Delivery of Shares Tendered in Payment of Purchase Price. If the Company permits the Recipient to exercise Options by delivery of shares of Common Stock of the Company, the certificate or certificates representing the shares of Common Stock of the Company to be delivered shall be duly executed in blank by the Recipient or shall be accompanied by a stock power duly executed in blank suitable for purposes of transferring such shares to the Company. Fractional shares of Common Stock of the Company will not be accepted in payment of the purchase price of shares acquired upon exercise of this Option.

(d) Use of Statutory Option Stock. Without derogating from the foregoing, “statutory option stock” (as defined below) may be tendered in payment of the exercise price of this Option even if the stock to be so tendered has not, at the time of tender, been held by the Recipient for the applicable minimum statutory holding period required to receive the tax benefits afforded under Section 421(a) of the Code with respect to such stock. The Recipient acknowledges that the tender of such “statutory option stock” may have adverse tax consequences to the Recipient. As used above, the term “statutory option stock” means stock acquired through the exercise of an incentive stock option or an option granted under an employee stock purchase plan. The tender of statutory option stock in payment of the exercise price of this Option shall be accompanied by written representation (in form satisfactory to the Company) stating whether such stock has been held by the Recipient for the applicable minimum statutory holding period.

6. Effect of Termination of Employment, Board Membership, or Service Provision or Death

This Option shall not be assignable or transferable either voluntarily or by operation of law, except as set forth in this Section 6. Notwithstanding the foregoing, an Option may be transferred pursuant to a domestic relations order, provided, however, that an “incentive stock option” may be deemed to be a nonqualified stock option as a result of such transfer. Further, notwithstanding the foregoing, the Recipient may, by delivering written notice to the Company, in a form provided by or otherwise satisfactory to the Company, designate a third party who, in the event of the death of the Recipient, shall thereafter be the beneficiary of an Option with the right to exercise the Option and receive the Common Stock or other consideration resulting from an Option exercise.

In the event the Recipient during his or her lifetime ceases to be an employee, member of the Board of Directors, or other service provider of the Company or of any subsidiary for any reason, other than death or disability, any unexercised portion of this Option which was otherwise exercisable on the date of termination of employment shall expire unless exercised within three months of that date, but in no event after the expiration of the term hereof.

In the event of termination of employment, board membership, or service in any other capacity because of the death or disability of the Recipient (i) while an employee, board member, or service provider of the Company or any subsidiary, or (ii) during the three-month period following termination of his or her employment, status as a director, or status as a service provider for any reason other than death or disability, this Option shall be exercisable for the number of shares otherwise exercisable on the date of death, disability or termination, by the Recipient or his or her personal representatives, heirs or legatees, as the case may be, at any time prior to the expiration of one (1) year from the date of the death or disability of the Recipient, but in no event after the expiration of the term hereof.

Notwithstanding the foregoing, if the Recipient, prior to the termination date of this Option, (i) violates any provision of any employment agreement or any confidentiality or other agreement between the Recipient and the Company, (ii) commits any felony or any crime involving fraud, dishonesty or moral turpitude under the laws of the United States or any state thereof, (iii) attempts to commit, or participate in, a fraud or act of dishonesty against the Company, or (iv) commits gross misconduct, the right to exercise this Option shall terminate immediately upon written notice to the Recipient from the Company describing such violation or act.

7. Employment, Board Membership or Service

Nothing contained in this Option or in the Plan shall be construed as giving the Recipient any right to be retained in the employ, board membership, or service of the Company or any of its subsidiaries.

8. Withholding Taxes

The Recipient acknowledges and agrees that the Company has the right to deduct from payments of any kind otherwise due to the Recipient any federal, state or local taxes of any kind required by law to be withheld with respect to exercise of this Option.

9. Plan Provisions

Except as otherwise expressly provided herein, this Option and the rights of the Recipient hereunder shall be subject to and governed by the terms and provisions of the Plan, including without limitation the provisions of Section 4 thereof.

10. Recipient Representation; Stock Certificate Legend

The Recipient hereby represents that he or she has received and read the Prospectus filed with the Securities and Exchange Commission as a part of the Registration Statement on Form S-8, which registered the shares under the Plan.

If the Recipient is an “affiliate” of the Company (as defined in Rule 144 promulgated under the Securities Act of 1933), all stock certificates representing shares of Common Stock issued to such Recipient pursuant to this Option shall have affixed thereto legends substantially in the following form:

“The shares represented by this certificate may be deemed to be held by an “affiliate” as defined by the Securities Act of 1933, as amended (the “Act”) and may not be sold, transferred or assigned unless such sale is pursuant to an effective registration statement under the Act or an opinion of counsel, satisfactory to the corporation, is obtained to the effect that such sale, transfer or assignment is exempt from the registration requirements of the Act.”

11. Notice

Any notice required to be given under the terms of this Option shall be properly addressed as follows: to the Company at its principal executive offices, and to the Recipient at his or her address set forth below, or at such other address as either of such parties may hereafter designate in writing to the other.

12. Qualification under Section 422

It is understood and intended that this Option shall qualify as an “incentive stock option” as defined in, and to the maximum extent permitted under, Section 422 of the Internal Revenue Code. Accordingly, the Recipient understands that in order to obtain the benefits of an incentive stock option under Section 421 of the Code, no sale or other disposition may be made of any shares acquired upon exercise of this Option within the one (1) year period beginning on the day after the day of the transfer of such shares to him or her, nor within the two (2) year period beginning on the day after the grant of this Option. If the Recipient intends to dispose or does dispose (whether by sale, exchange, gift, transfer or otherwise) of any such shares within said periods, he or she will notify the Company within thirty (30) days after such disposition.

13. Enforceability

This Option shall be binding upon the Recipient, his or her estate, and his or her personal representatives and beneficiaries.

14. Effective Date

The effective date of this Option is June 25, 2012.

[Remainder of page intentionally left blank.]

IN WITNESS WHEREOF, this Option has been executed by a duly authorized officer of the Company as of the effective date.

		AMAG Pharmaceuticals, Inc.


		By:
			Name: Frank E. Thomas
			Title: Chief Operating Officer


Recipient’s Acceptance:

The undersigned hereby accepts this Option and agrees to the terms and provisions set forth in this Option and in the Plan (a copy of which has been delivered to him/her).



(Signature of Recipient)



Lee F. Allen, M.D., Ph.D.


Address:



Date:	June 25, 2012

EX-10.3 4 a12-15637_1ex10d3.htm EX-10.3

Exhibit 10.3

Stock Option Grant

1. Grant of Option

AMAG Pharmaceuticals, Inc., a Delaware corporation (the “Company”), hereby grants to Christopher G. White (the “Recipient”), an option to purchase 40,000 shares of Common Stock, $.01 par value per share, of the Company as hereinafter set forth (the “Option”), pursuant and subject to the terms and provisions of the Company’s Second Amended and Restated 2007 Equity Incentive Plan (the “Plan”). The date of grant of this Option is June 25, 2012.

All terms which are defined in the Plan shall have the same meanings herein.

2. Vesting of Option

This Option shall be exercisable in cumulative installments on each of the following dates, as follows:

Date Exercisable		Number of Shares Exercisable

On date of grant		0

On June 25, 2013		10,000

On September 25, 2013		12,500

On December 25, 2013		15,000

On March 25, 2014		17,500

On June 25, 2014		20,000

On September 25, 2014		22,500

On December 25, 2014		25,000

On March 25, 2015		27,500

On June 25, 2015		30,000

On September 25, 2015		32,500

On December 25, 2015		35,000

On March 25, 2016		37,500

On June 25, 2016		40,000

Stock Option Agreement

Except as set forth in this paragraph, no additional shares shall vest and become exercisable between each of the vesting dates set forth above. In the event that while the Recipient continues to have primary responsibility over the Company’s business development function, the Company acquires a product approved by the U.S. Food and Drug Administration that has generated at least $10 million in revenue during the 12 month period preceding the acquisition, whether by the acquisition of a company, acquisition of the product related assets or through a licensing transaction, then the vesting of 50% of the number of shares subject to the Option that then remain unexercisable shall become exercisable by accelerating the vesting of 50% of the shares with respect to each remaining vesting date. In the event that after the transaction described in the preceding sentence has closed, and while the Recipient continues to have primary responsibility over the Company’s business development function, the Company acquires a second product in a transaction that (1) would be required to be reported under item 1.01 of Form 8-K as a “material contract” or (2) is otherwise deemed by the Board of Directors at the time of their approval to be of material importance to the Company’s growth strategy, then all remaining shares subject to the Option shall become exercisable.

3. Term of Option

Unless terminated earlier as provided in Section 6 below, this Option shall terminate in seven (7) years on June 25, 2019.

4. Exercise Price

The exercise price of this Option shall be fourteen dollars and eighty-nine cents ($14.89) per share.

5. Exercise and Payment

(b) Valuation of Shares Tendered in Payment of Purchase Price. For the purposes hereof, the fair market value of any share of the Company’s

Common Stock which may be delivered to the Company in exercise of this Option shall be determined in good faith by the Board of Directors of the Company, or, in the absence of such determination, shall be equal to the closing price of a share of the Company’s Common Stock as reported on the Nasdaq Global Market (or other national securities exchange or automated marketplace upon which the Company’s Common Stock is then traded) on the date of exercise of this Option.

6. Effect of Termination of Employment, Board Membership, or Service Provision or Death

this Option which was otherwise exercisable on the date of termination of employment shall expire unless exercised within three months of that date, but in no event after the expiration of the term hereof.

7. Employment, Board Membership or Service

8. Withholding Taxes

9. Plan Provisions

10. Recipient Representation; Stock Certificate Legend

11. Notice

12. Qualification under Section 422

13. Enforceability

This Option shall be binding upon the Recipient, his or her estate, and his or her personal representatives and beneficiaries.

14. Effective Date

The effective date of this Option is June 25, 2012.

[Remainder of page intentionally left blank.]

IN WITNESS WHEREOF, this Option has been executed by a duly authorized officer of the Company as of the effective date.

		AMAG Pharmaceuticals, Inc.


		By:
			Name: Frank E. Thomas
			Title: Chief Operating Officer


Recipient’s Acceptance:

The undersigned hereby accepts this Option and agrees to the terms and provisions set forth in this Option and in the Plan (a copy of which has been delivered to him/her).



(Signature of Recipient)


Christopher G. White
(Print Name of Recipient)


Address:



Date:	June 25, 2012

EX-99.1 5 a12-15637_1ex99d1.htm EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

AMAG Pharmaceuticals Realigns Operating Cost Structure to Focus on Continued Feraheme Growth and Business Development Activities

LEXINGTON, MA (June 25, 2012) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced a number of changes to its operating expenses that further align its cost structure with the company’s focus on advancing Feraheme® and expanding its product portfolio with commercial stage assets. First, AMAG is moving to an outsourced manufacturing model and intends to divest the company’s manufacturing facility in Cambridge, MA. Additionally, the company’s global phase III broad iron deficiency anemia (IDA) clinical program for Feraheme, which will support an sNDA filing later this year, will conclude this year. Along with the natural attrition of external development costs associated with the conclusion of the IDA development program, AMAG is reducing internal development expenses to match the reduced activities at this time, and will continue to adapt development resources to meet the company’s future development needs.

“The decision to eliminate positions is never easy and I want to thank the impacted individuals who have contributed greatly to AMAG over the years. Today’s announcement signals a continuation of AMAG’s transformation into a highly focused, commercially oriented specialty pharmaceutical company,” said William Heiden, president and chief executive officer of AMAG. “The actions that the company took in November 2011, coupled with the actions announced today, mark continuing progress in implementing a strategy to become a leaner and nimbler company focused on providing specialty drugs to hematology/oncology and hospital sites of care. These changes will allow AMAG to more efficiently make decisions, react quickly to changing market dynamics and rapidly identify and evaluate new product opportunities — these are important changes that will help ensure our success in the short- and long-term.”

Heiden continued, “Our corporate structure, both in terms of financial and human resources, is now being brought into alignment with our corporate strategy. We are focusing these resources against two key priorities for the organization. First, advancing Feraheme across our four growth opportunities of increasing market share in our current indication in the US, pursuing a broader label expansion for all patients with IDA, geographic expansion through international launches and expansion of the IV iron market. We are also focusing aggressively on our second corporate priority of expanding our product portfolio with specialty drugs that fit into our commercial call points. I believe that the combination of Feraheme, our strong balance sheet and our experienced leadership team give us a very strong base from which to continue to build a profitable specialty pharmaceutical company — the steps taken today demonstrate the real and continuing progress that we are making towards achieving this goal.”

Plan Details

· By year-end 2012, AMAG expects to reduce its workforce by approximately 45 positions, the majority of which are expected to be associated with the company’s manufacturing and development infrastructure. Some of the eliminated positions are budgeted, open positions that the company will not fill. The company expects to incur approximately $1.0 million in charges associated with the restructuring, which will be spread over the remainder of 2012, with $0.5 million expected to be recognized in the second quarter of 2012.

· With the intended divestiture of the company’s manufacturing facility, AMAG will stop producing GastroMark and has entered into agreements with the commercial parties that sell GastroMark in the US and EU. AMAG will incur one-time costs associated with the GastroMark agreements of $1.6 million in the second quarter of 2012. The company expects to sell its Cambridge, MA manufacturing facility, which AMAG owns outright.

· The changes implemented in 2012, will result in reduced employee-related operating expenses beginning in 2013. In addition, external research and development expenses associated with the company’s broad IDA clinical development program planned for 2012 will not recur, leading to further reductions in the company’s 2013 operating expenses. The full impact of these reductions will be communicated when the company issues its 2013 financial guidance, later this year.

· The expected change in manufacturing supply chain strategy for the company will lower the costs associated with the manufacture of Feraheme. The company expects that these changes will result in lower costs of goods sold beginning in 2014.

The company may provide updated 2012 financial guidance when it reports second quarter financial results.

About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets ferumoxytol under the brand name Feraheme® in the United States. For additional company information, please visit www.amagpharma.com.

About Feraheme (ferumoxytol)
In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Feraheme received marketing approval in Canada in December 2011 and in the European Union in June 2012. For additional product information, please visit www.feraheme.com.

AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.

Forward Looking Statements

not describe historical facts, including but not limited to statements regarding: the divestiture of our manufacturing facility in Cambridge, MA; the conclusion of the global phase III broad iron deficiency anemia clinical program for Feraheme by the end of 2012; the expected filing of an sNDA with respect to a broad iron deficiency anemia indication for Feraheme by the end of 2012; the expectation that changes at AMAG will help ensure our success in the short- and long-term; the expected $1 million in charges related to the restructuring; the expected reduction in operating expenses in 2013; the lowering of costs associated with the manufacturing of Feraheme; and the expected reduction in cost of goods sold in 2014 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 and Takeda’s ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the U.S. and in territories outside of the U.S., including the European Union, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (4) uncertainties regarding the manufacture of Feraheme/Rienso, (5) uncertainties relating to our patents and proprietary rights, and (6) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012. 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.

Company Contact:
Amy Sullivan

AMAG Pharmaceuticals, Inc.; 617-498-3303

EX-99.2 6 a12-15637_1ex99d2.htm EX-99.2

Exhibit 99.2

FOR IMMEDIATE RELEASE

Rienso® (Ferumoxytol) Receives European Marketing Authorization for the Treatment of Iron Deficiency Anemia in Adult Patients with Chronic Kidney Disease

Marketing Authorization Triggers $15 Million Milestone Payment to AMAG

LEXINGTON, MA (June 22, 2012) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). The marketing authorization follows a positive opinion, issued on April 19, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Ferumoxytol was approved for the same indication in the US under the brand name Feraheme® in June 2009.

The marketing authorization is valid in the current European Union Member States as well as in Iceland and Norway, and is based on data obtained from an extensive clinical development program. Takeda Pharmaceutical Company Limited, AMAG’s partner in Europe, plans to launch ferumoxytol in Europe under the brand name Rienso® in 2012. The EU marketing authorization triggers a $15 million milestone payment to AMAG from Takeda; the first commercial sale of Rienso® in Europe will trigger another $15 million milestone payment to AMAG. Additionally, AMAG is entitled to receive tiered, double-digit royalties on sales of Rienso® in the licensed territories.

“AMAG has four significant organic growth opportunities for ferumoxytol — continued share gains in the US CKD IDA market, international launches and market penetration, label expansion in the US and abroad, and overall IV iron market expansion,” said William Heiden, president and chief executive officer of AMAG. “We are very fortunate to have a committed partner with an outstanding reputation in the pharmaceutical industry responsible for the launch of ferumoxytol in many regions outside of the United States. Through Takeda’s efforts, patients outside the US with CKD will soon benefit from a new therapy to treat their IDA.”

Iron deficiency is a common cause of anemia in CKD patients, and is very common in the later stages of CKD as renal function deteriorates and erythropoiesis (red blood cell production) declines. IDA can have a profound impact on patients’ lives, causing fatigue, shortness of breath and an increase in the risk of cardiovascular complications including congestive heart failure.(1) IV iron is recommended for use to increase hemoglobin levels in CKD patients with IDA. (1) Approximately one million grams of IV iron are administered to IDA patients in the EU each year.

“While treatments for iron deficiency anemia have been widely available for many years, the disease continues to place a significant burden on the everyday life of CKD patients worldwide, and its management should be tailored to appropriately address the clinical consequences of this debilitating condition,” said Francesco Locatelli, Scientific Director, Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy. “Ferumoxytol offers an effective alternative to current therapies in the management of anemia, and news of its approval will be warmly received by the European renal community.”

About Feraheme (ferumoxytol)
In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the US Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the US shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it will be marketed by Takeda as Feraheme®, and in the European Union in June 2012, where it will be marketed by Takeda as Rienso®. For additional product information, please visit www.feraheme.com.

AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.

Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.

(1) National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006;47(suppl 3):11—1458

The important safety information below is based on the United States prescribing information.

Important Safety Information About Feraheme

Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.

Warnings and precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel

and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects.

Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme injection. 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, CT, PET, SPECT, ultrasound, or nuclear imaging.

Adverse reactions

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.

Post-marketing safety experience

The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.

For full prescribing information, please visit www.feraheme.com.

Forward Looking Statements

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: the areas of significant organic growth opportunities for ferumoxytol, Takeda’s expected 2012 launch of ferumoxytol in the EU and Canada, and any milestone payments and royalties we may receive following such launch 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 and Takeda’s ability to successfully compete in the intravenous iron replacement market both in the US and outside the US, including the EU, (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the US and in territories outside of the US, including the EU, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (4) uncertainties regarding our ability to manufacture Feraheme/Rienso, (5) uncertainties relating to our patents and proprietary rights, and (6) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

Company Contact:
Amy Sullivan

AMAG Pharmaceuticals, Inc.; 617-498-3303

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