Document:

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.

 

(c)          A new section 1.108 is hereby added to the Agreement to read in its entirety as follows:

 

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.

 

(c)                                  Section 7.3 of the Agreement is hereby amended to read in its entirety as follows:

 

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 

 

[***] 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.

 

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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 

 

[***] 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.

 

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

 

[***] 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.

 

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[***]
    	
 
    	
[***]
    	
 
    
	
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 

 

[***] 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.

 

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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 

 

[***] 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.

 

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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 

 

[***] 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.

 

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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.

 

[***] 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.

 

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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-1Exhibit 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
    	
 
    	
 
    

 

1

 

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

 

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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.

 

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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:

 

4

 

“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.]

 

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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
    	
 
    	
 
    
						

 

6

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