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Exhibit 10.1    
    

AMPHASTAR PHARMACEUTICALS, INC.

AMENDED 2002 STOCK OPTION/STOCK

ISSUANCE PLAN  

Approved by Stockholders on July 15, 2004  

 
AMPHASTAR PHARMACEUTICALS, INC.

AMENDED 2002 STOCK OPTION/STOCK

ISSUANCE PLAN  

TABLE OF CONTENTS  

	 
	 	Page

	SECTION 1.        ESTABLISHMENT AND PURPOSE	 	4
	

SECTION 2.        ADMINISTRATION	
 	

4
	 	 	
 (a) Committees of the Board of Directors	
 	

4
	 	 	(b) Authority of the Board of Directors	 	4
	

SECTION 3.        ELIGIBILITY	
 	

4
	 	 	
 (a) General Rule	
 	

4
	 	 	(b) Ten-Percent Stockholders	 	4
	

SECTION 4.        STOCK SUBJECT TO PLAN	
 	

4
	 	 	
 (a) Basic Limitation	
 	

4
	 	 	(b) Additional Shares	 	5
	 	 	(c) Section 162(m) Limitation	 	5
	

SECTION 5.        TERMS AND CONDITIONS OF AWARDS OR SALES	
 	

5
	 	 	
 (a) Stock Purchase Agreement	
 	

5
	 	 	(b) Duration of Offers and Nontransferability of Rights	 	5
	 	 	(c) Purchase Price	 	5
	 	 	(d) Withholding Taxes	 	5
	 	 	(e) Restrictions on Transfer of Shares and Minimum Vesting	 	5
	

SECTION 6.        TERMS AND CONDITIONS OF OPTIONS	
 	

6
	 	 	
 (a) Stock Option Agreement	
 	

6
	 	 	(b) Number of Shares	 	6
	 	 	(c) Exercise Price	 	6
	 	 	(d) Exercisability	 	6
	 	 	(e) Accelerated Exercisability	 	6
	 	 	(f) Basic Term	 	6
	 	 	(g) Termination of Service (Except by Death)	 	6
	 	 	(h) Leaves of Absence	 	7
	 	 	(i) Death of Optionee	 	7
	 	 	(j) Restrictions on Transfer of Shares and Minimum Vesting	 	7
	 	 	(k) Transferability of Options	 	7
	 	 	(l) Withholding Taxes	 	7
	 	 	(m) No rights as a Stockholder	 	8
	 	 	(n) Modification, Extension and Assumption of Options	 	8
	 	 	 

2

 

	

SECTION 7.        PAYMENTS FOR SHARES	
 	

8
	 	 	
 (a) General Rule	
 	

8
	 	 	(b) Surrender of Stock	 	8
	 	 	(c) Services Rendered	 	8
	 	 	(d) Exercise/Sale	 	8
	 	 	(e) Exercise/Pledge	 	8
	

SECTION 8.        ADJUSTMENT OF SHARES	
 	

8
	 	 	
 (a) General	
 	

8
	 	 	(b) Mergers and Consolidations	 	9
	 	 	(c) Reservation of Rights	 	9
	

SECTION 9.        SECURITIES LAWS REQUIREMENTS	
 	

9
	 	 	
 (a) General	
 	

9
	 	 	(b) Financial Reports	 	9
	

SECTION 10.        NO RETENTION RIGHTS	
 	

9
	

SECTION 11.        DURATION AND AMENDMENTS	
 	

10
	 	 	
 (a) Term of the Plan	
 	

10
	 	 	(b) Right to Amend or Terminate the Plan	 	10
	 	 	(c) Effect of Amendment or Termination	 	10
	

SECTION 12.        DEFINITIONS	
 	

10
	

SECTION 13.        EXECUTION	
 	

12

3

 
Amphastar Pharmaceuticals, Inc.  

 Amended 2002 Stock Option/Stock Issuance Plan  

SECTION 1.    ESTABLISHMENT AND PURPOSE.  

        The purpose of the Plan is to offer selected persons an opportunity to acquire a proprietary interest in the success of the Company, or to increase such interest,
by purchasing Shares of the Company's Stock. The Plan provides both for the grant of Options to purchase Shares and the direct award or sale of Shares. Options granted under the Plan may include
Nonstatutory Options as well as ISOs intended to qualify under Section 422 of the Code. Capitalized terms are defined in Section 12. 

SECTION 2.    ADMINISTRATION.  

        (a)    Committees of the Board of Directors.    The Plan may be administered by a Committee of the Board of Directors.
The Committee shall consist of at least two non-employee members (Outside Directors) of the Board of Directors who have been appointed by the Board of Directors. The Committee shall have
such authority and be responsible for such functions as the Board of Directors has assigned to it. If no Committee has been appointed, the entire Board of Directors shall administer the Plan. Any
reference to the Board of Directors in the Plan shall be construed as a reference to the Committee (if any) to whom the Board of Directors has assigned a particular f[11]ction. 

        Solely
for the purpose of administering awards granted to Outside Directors, all employee members of the Board of Directors will be considered the Committee under the Plan. Among other
things, this
employee Committee shall be responsible for granting awards to Outside Directors and interpreting provisions of the Plan as they relate to these awards. 

        (b)    Authority of the Committee.    Subject to the provisions of the Plan, the Committee shall have full authority
and discretion to take any actions it deems necessary or advisable for the administration of the Plan. All decisions, interpretations and other actions of the Committee shall be final and binding on
all Purchasers, all Optionees and all persons deriving their rights from a Purchaser or Optionee. 

SECTION 3.    ELIGIBILITY.  

        (a)    General Rule.    Only Employees, Outside Directors and Consultants shall be eligible for the grant of
Nonstatutory Options or the direct award or sale of Shares. Only Employees shall be eligible for the grant of ISOs. 

        (b)    Ten-Percent Stockholders.    A person who owns more than 10% of the total combined voting power of
all classes of outstanding stock of the Company, its Parent or any of its Subsidiaries shall not be eligible for designation as an Optionee or Purchaser unless (i) the Exercise Price is at
least 110% of the Fair Market Value of a Share on the date of grant, (ii) the Purchase Price (if any) is at least 100% of the Fair Market Value of a Share and (iii) in the case of an
ISO, such ISO by its terms is not exercisable after the expiration of five years from the date of grant. For purposes of this Subsection (b), in determining stock ownership, the attribution rules of
Section 424(d) of the Code shall be applied. 

SECTION 4.    SHARES SUBJECT TO PLAN.  

        (a)    Basic Limitation.    Not more than 6,400,000 Shares may be issued under the Plan (subject to Subsection
(b) below and Section8). The number of Shares that are subject to Options or other rights outstanding at any time under the Plan shall not exceed the number of Shares that then remain available
for issuance under the Plan. The Company, during the term of the Plan, shall at all times reserve and keep available sufficient Shares to satisfy the requirements of the Plan. Shares offered under the
Plan shall be authorized but unissued Shares. 

4

 

        (b)    Additional Shares.    In the event that Shares previously issued under the Plan are reacquired by the Company
pursuant to a forfeiture provision, right of repurchase or right of first refusal such Shares shall be added to the number of Shares then available for issuance under the Plan. However, the aggregate
number of Shares issued upon the exercise of IS Os (including Shares reacquired by the Company) shall in no event exceed 200% of the number specified in Subsection (a) above, cumulatively over
the life of the Plan. In the event that an outstanding Option or other right for any reason expires or is canceled, the Shares allocable to the unexercised portion of such Option or other right shall
not reduce the number of Shares available for issuance under the Plan. 

        (c)    Section 162(m) Limitation.    Subject to the provisions of Section 8 relating to adjustments upon
changes in stock, no person shall be eligible to be granted Stock awards covering more than Four Hundred Thousand (400,000) shares of the Company's Stock in any calendar year. 

SECTION 5.    TERMS AND CONDITIONS OF AWARDS OR SALES.  

        (a)    Stock Purchase Agreement.    Each award or sale of Shares under the Plan (other than upon exercise of an
Option) shall be evidenced by a Stock Purchase Agreement between the Purchaser and the Company. Such award or sale shall be subject to all applicable terms and conditions of the Plan and may be
subject to any other tem1S and conditions which are not inconsistent with the Plan and which the Committee deems appropriate for inclusion in a Stock Purchase Agreement. The provisions of the various
Stock Purchase Agreements entered into under the Plan need not be identical. 

        (b)    Duration of Offers and Nontransferability of Rights.    Any right to acquire Shares under the Plan (other than
an Option) shall automatically expire if not exercised by the Purchaser within 30 days after the grant of such right was communicated to the Purchaser by the Company. Such right shall not be
transferable and shall be exercisable only by the Purchaser to whom such right was granted. 

        (c)    Purchase Price.    The Purchase Price of Shares to be offered under the Plan shall not be less than 100% of the
Fair Market Value of such Shares, and a higher percentage may be required by Section 3(b). Subject to the preceding sentence, the Committee shall determine the Purchase Price at its sole
discretion. The Purchase Price shall be payable in a form described in Section 7. 

        (d)    Withholding Taxes.    As a condition to the purchase of Shares, the Purchaser shall make such arrangements as
the Committee may require for the satisfaction of any federal, state, local or foreign withholding tax obligations that may arise in connection with such purchase. 

        (e)    Restrictions on Transfer of Shares and Minimum Vesting.    Any Shares awarded or sold under the Plan may be
subject to such special forfeiture conditions, rights of repurchase, rights of first refusal and other transfer restrictions as the Committee may determine. Such restrictions shall be set forth in the
applicable Stock Purchase Agreement and shall apply in addition to any restrictions that may apply to holders of Shares generally. In the case of a Purchaser who is not an officer of the Company, an
Outside Director or a Consultant: 

	(i)
	Any
right to repurchase the Purchaser's Shares at the original Purchase Price (if any) upon termination of the Purchaser's Service shall lapse at least as rapidly as 20% after year 1
and monthly thereafter over the four-year period commencing on the date of the award or sale of the Shares;

	(ii)
	Any
such right may be exercised only for cash or for cancellation of indebtedness incurred in purchasing the Shares; and

	(iii)
	Any
such right may be exercised only within 90 days after the termination of the Purchaser's Service. 

5

 

SECTION 6.    TERMS AND CONDITIONS OF OPTIONS.  

        (a)    Stock Option Agreement.    Each grant of an Option under the Plan shall be evidenced by a Stock Option
Agreement between the Optionee and the Company. The Option shall be subject to all applicable terms and conditions of the Plan and may be subject to any other terms and conditions which are not
inconsistent with the Plan and which the Committee deems appropriate for inclusion in a Stock Option Agreement. The provisions of the various Stock Option Agreements entered into under the Plan need
not be identical. 

        (b)    Number of Shares.    Each Stock Option Agreement shall specify the number of Shares that are subject to the
Option and shall provide for the adjustment of such number in accordance with Section 8. The Stock Option Agreement shall also specify whether the Option is an ISO or a Nonstatutory Option. 

        (c)    Exercise Price.    Each Stock Option Agreement shall specify the Exercise Price. The Exercise Price of an ISO
shall not be less than 100% of the Fair Market Value of a Share on the date of grant, and a higher percentage may be required by Section 3(b). The Exercise Price of a Nonstatutory Option shall
not be less than 85% of the Fair Market Value of a Share on the date of grant, and a higher percentage may be required by Section 3(b). Subject to the preceding two sentences, the Exercise
Price under any Option shall be detem1ined by the Committee at its sole discretion. The Exercise Price shall be payable in a form described in Section 7. 

        (d)    Exercisability.    Each Stock Option Agreement shall specify the date when all or any installment of the Option
is to become exercisable. No Option shall be exercisable unless the Optionee has delivered an executed copy of the Stock Option Agreement to the Company. In the case of an Optionee who is not an
officer of the Company, an Outside Director or a Consultant, an Option shall become exercisable at least as rapidly as 20% per year over the five-year period commencing on the date of
grant. Subject to the preceding sentence, the Committee shall determine the exercisability provisions of the Stock Option Agreement at its sole discretion. 

        (e)    Accelerated Exercisability.    Unless the applicable Stock Option Agreement provides otherwise, all of an
Optionee's Options shall become immediately exercisable in full if either: 

	(i)
	(A)
the Company is subject to a Change in Control before the Optionee's Service terminates, (B) the plan for the Change of Control does not allow such Options to remain
outstanding, (C) such Options are not assumed by the surviving corporation or its parent resulting from the Change of Control and (D) the surviving corporation or its parent resulting
from the Change of Control does not substitute options with substantially the same terms for such Options; or

	(ii)
	the
Optionee is terminated within one (1) year of a Change of Control. 

        (f)    Basic Term.    The Stock Option Agreement shall specify the term of the Option. The term shall not exceed
10 years from the date of grant, and a shorter term may be required by Section 3(b). Subject to the preceding sentence, the Committee at its sole discretion shall determine when an
Option is to expire. 

        (g)    Termination of Service (Except by Death).    If an Optionee's Service terminates for any reason other than the
Optionee's death, then the Optionee's Options shall expire on the earliest of the following occasions: 

	(i)
	The
expiration date determined pursuant to Subsection (f) above;

	(ii)
	The
date three months after the tem1ination of the Optionee's Service for any reason other than Disability, or such later date as the Committee may determine; or

	(iii)
	The
date 12 months after the termination of the Optionee's Service by reason of Disability, or such later date as the Committee may determine. 

6

 

The
Optionee may exercise all or part of the Optionee's Options at any time before the expiration of such Options under the preceding sentence, but only to the extent that such Options had become
exercisable before the Optionee's Service terminated (or became exercisable as a result of the termination). The balance of such Options shall lapse when the Optionee's Service terminates. In the
event that the Optionee dies after the termination of the Optionee's Service but before the expiration of the Optionee's Options, all or part of such Options may be exercised (prior to expiration) by
the executors or administrators of the Optionee's estate or by any person who has acquired such Options directly from the Optionee by beneficiary designation, bequest or inheritance, but only to the
extent that such Options had become exercisable before the Optionee's Service terminated (or became exercisable as a result of the termination). 

        (h)    Leaves of Absence.    For purposes of Subsection (g) above, Service shall be deemed to continue while
the Optionee is on a bona fide leave of absence, if such leave was approved by the Company in writing and if continued crediting of Service for this purpose is expressly required by the terms of such
leave or by applicable law (as determined by the Company). 

        (l)    Death of Optionee.    If an Optionee dies while the Optionee is in Service, then the Optionee's Options shall
expire on the earlier of the following dates: (i) The expiration date detem1ined pursuant to Subsection (f) above; or (ii) The date 12 months after the Optionee's death, or
such later date as the Committee may determine. All or part of the Optionee's Options may be exercised at any time before the expiration of such Options under the preceding sentence by the executors
or administrators of the Optionee's estate or by any person who has acquired such Options directly from the Optionee by beneficiary designation, bequest or inheritance, but only to the extent that
such Options had become exercisable before the Optionee's death (or became exercisable as a result of the death). The balance of such Options shall lapse when the Optionee dies. 

        (j)    Restrictions on Transfer of Shares and Minimum Vesting.    Any Shares issued upon exercise of an Option may be
subject to such special forfeiture conditions, rights of repurchase, rights of first refusal and other transfer restrictions as the Committee may detem1ine. Such restrictions shall be set forth in the
applicable Stock Option Agreement and shall apply in addition to any restrictions that may apply to holders of Shares generally. In the case of an Optionee who is not an officer of the Company, an
Outside Director or a Consultant: 

	(i)
	Any
Tight to repurchase the Optionee's Shares at the original Exercise Price upon termination of the Optionee's Service shall lapse at least as rapidly as 25% per year after year 1
and monthly thereafter over the four-year period commencing on the date of the option grant;

	(ii)
	Any
such right may be exercised only for cash or for cancellation of indebtedness incurred in purchasing the Shares; and

	(iii)
	Any
such right may be exercised only within 90 days after the later of (A) the termination of the Optionee's Service or (B) the date of the option exercise. 

        (k)    Transferability of Options.    An Option shall be transferable by the Optionee only by (i) a beneficiary
designation, (ii) a will or (iii) the laws of descent and distribution, except as provided in the next sentence. If the stock is publicly traded, an NSO shall also be transferable by the
Optionee by (i) a gift to a member of the Optionee's Immediate Family or (ii) a gift to an inter vivos or testamentary trust in which members of the Optionee's Immediate Family have a
beneficial interest of more than 50% and which provides that such NSO is to be transferred to the beneficiaries upon the Optionee's death. An ISO may be exercised during the lifetime of the Optionee
only by the Optionee or by the Optionee's guardian or legal representative. 

        (l)    Withholding Taxes.    As a condition to the exercise of an Option, the Optionee shall make such arrangements as
the Committee may require for the satisfaction of any federal, state, local or 

7

 

foreign
withholding tax obligations that may arise in connection with such exercise. The Optionee shall also make such arrangements as the Committee may require for the satisfaction of any federal,
state, local or foreign withholding tax obligations that may arise in connection with the disposition of Shares acquired by exercising an Option. 

        (m)    No Rights as a Stockholder.    An Optionee, or a transferee of an Optionee, shall have no rights as a
stockholder with respect to any Shares covered by the Optionee's Option until such person becomes entitled to receive such Shares by filing a notice of exercise and paying the Exercise Price pursuant
to the terms of such Option. 

        (n)    Modification, Extension and Assumption of Options.    Within the limitations of the Plan, the Committee may
modify, extend or assume outstanding Options or may accept the cancellation of outstanding Options (whether granted by the Company or another issuer) in return for the grant of new Options for the
same or a different number of Shares and at the same or a different Exercise Price. The foregoing notwithstanding, no modification of an Option shall, without the consent of the Optionee, impair the
Optionee's rights or increase the Optionee's obligations under such Option. 

SECTION 7.    PAYMENT FOR SHARES.  

        (a)    General Rule.    The entire Purchase Price of Shares or Exercise Price of Options issued under the Plan shall
be payable in cash or cash equivalents at the time when such Shares are purchased, except as otherwise provided in this Section7. 

        (b)    Surrender of Stock.    To the extent that a Stock Option Agreement so provides, all or any part of the Exercise
Price may be paid by surrendering, or attesting to the ownership of, Shares that are already owned for at least six months by the Optionee. Such Shares shall be surrendered to the Company in good fom1
for transfer and shall be valued at their Fair Market Value on the date when the Option is exercised. The Optionee shall not surrender, or attest to the ownership of, Shares in payment of the Exercise
Price if such action would cause the Company to recognize compensation expense (or additional compensation expense) with respect to the Option for financial reporting purposes. 

        (c)    Services Rendered.    At the discretion of the Committee, Shares may be awarded under the Plan in consideration
of services rendered to the Company, a Parent or a Subsidiary prior to the award. 

        (d)    Exercise/Sale.    To the extent that a Stock Option Agreement so provides, and if Stock is publicly traded,
payment may be made all or in part by the delivery (on a form prescribed by the Company) of an irrevocable direction to a securities broker approved by the Company to sell Shares and to deliver all or
part of the sales proceeds to the Company in payment of all or part of the Exercise Price and any withholding taxes. 

        (e)    Exercise/Pledge.    To the extent that a Stock Option Agreement so provides, and if Stock is publicly traded,
payment may be made all or in part by the delivery (on a form prescribed by the Company) of an irrevocable direction to pledge Shares to a securities broker or lender approved by the Company, as
security for a loan, and to deliver all or part of the loan proceeds to the Company in payment of all or part of the Exercise Price and any withholding taxes. 

SECTION 8.    ADJUSTMENT OF SHARES.  

        (a)    General.    In the event of a subdivision of the outstanding Stock, a declaration of a dividend payable in
Shares, a declaration of an extraordinary dividend payable in a form other than Shares in an amount that has a material effect on the Fair Market Value of the Stock, a combination or consolidation of
the outstanding Stock into a lesser number of Shares, a recapitalization, a spin-off, a reclassification or a similar occurrence, the Committee shall make appropriate adjustments in one or 

8

 

more
of (i) the number of Shares available for future grants under Section4, (ii) the number of Shares covered by each outstanding Option or (iii) the Exercise Price under each
outstanding Option. 

        (b)    Mergers and Consolidations.    In the event that the Company is a party to a merger or consolidation,
outstanding Options shall be subject to the agreement of merger or consolidation. Such agreement shall provide for: 

	(i)
	The
continuation of such outstanding Options by the Company (if the Company is the surviving corporation);

	(ii)
	The
assumption of the Plan and such outstanding Options by the surviving corporation or its parent;

	(iii)
	The
substitution by the surviving corporation or its parent of options with substantially the same terms for such outstanding Options;

	(iv)
	The
full exercisability of such outstanding Options and full vesting of the Shares subject to such Options, followed by the cancellation of such Options; or

	(v)
	The
settlement of the full value of such outstanding Options (whether or not then exercisable) in cash or cash equivalents, followed by the cancellation of such Options. 

        (c)    Reservation of Rights.    Except as provided in this Section 8, an Optionee or Purchaser shall have no
rights by reason of (i) any subdivision or consolidation of shares of stock of any class, (ii) the payment of any dividend or (iii) any other increase or decrease in the number of
shares of stock of any class. Any issuance by the Company of shares of stock of any class, or securities convertible into shares of stock of any class, shall not affect, and no adjustment by reason
thereof shall be made with respect to, the number or Exercise Price of Shares subject to an Option. The grant of an Option pursuant to the Plan shall not affect in any way the right or power of the
Company to make adjustments, reclassifications, reorganizations or changes of its capital or business structure, to merge or consolidate or to dissolve, liquidate, sell or transfer all or any part of
its business or assets. 

SECTION 9.    SECURITIES LAW REQUIREMENTS.  

        (a)    General.    Shares shall not be issued under the Plan unless the issuance and delivery of such Shares comply
with (or are exempt from) all applicable requirements of law, including (without limitation) the Securities Act of 1933, as amended, the rules and regulations promulgated thereunder, state securities
laws and regulations, and the regulations of any stock exchange or other securities market on which the Company's securities may then be traded. 

        (b)    Financial Reports.    The Company each year shall furnish to Optionees, Purchasers and stockholders who have
received Stock under the Plan its balance sheet and income statement, unless such Optionees, Purchasers or stockholders are key Employees whose duties with the Company assure them access to equivalent
information. Such balance sheet and income statement need not be audited. 

SECTION 10.    NO RETENTION RIGHTS.  

        Nothing in the Plan or in any right or Option granted under the Plan shall confer upon the Purchaser or Optionee any right to continue in Service for any period
of specific duration or interfere with or otherwise restrict in any way the rights of the Company (or any Parent or Subsidiary employing or retaining the Purchaser or Optionee) or of the Purchaser or
Optionee, which rights are hereby expressly reserved by each, to terminate his or her Service at any time and for any reason, with or without cause. 

9

 

SECTION 11.    DURATION AND AMENDMENTS.  

        (a)    Term of the Plan.    The Plan, as set forth herein, shall become effective on the date of its adoption by the
Board of Directors, subject to the approval of the Company's stockholders. If the stockholders fail to approve the Plan within 12 months after its adoption by the Board of Directors, then any
grants, exercises or sales that have already occurred under the Plan shall be rescinded and no additional
grants, exercises or sales shall thereafter be made under the Plan. The Plan shall terminate automatically 10 years after the later of (i) its adoption by the Board of Directors or
(ii) the most recent increase in the number of Shares reserved under Section4 that was approved by the Company's stockholders. The Plan may be terminated on any earlier date pursuant to
Subsection (b) below. 

        (b)    Right to Amend or Terminate the Plan.    The Board of Directors may amend, suspend or terminate the Plan at any
time and for any reason; provided, however, that any amendment of the Plan shall be subject to the approval of the Company's stockholders if it (i) increases the number of Shares available for
issuance under the Plan (except as provided in Section 8) or (ii) materially changes the class of persons who are eligible for the grant of ISOs. Stockholder approval shall not be
required for any other amendment of the Plan. If the stockholders fail to approve an increase in the number of Shares reserved under Section4 within 12 months after its adoption by the Board of
Directors, then any grants, exercises or sales that have already occurred in reliance on such increase shall be rescinded and no additional grants, exercises or sales shall thereafter be made in
reliance on such increase. 

        (c)    Effect of Amendment or Termination.    No Shares shall be issued or sold under the Plan after the termination
thereof, except upon exercise of an Option granted prior to such termination. The termination of the Plan, or any amendment thereof, shall not affect any Share previously issued or any Option
previously granted under the Plan. 

SECTION 12.    DEFINITIONS.  

        (a)   "Board of Directors" shall mean the Board of Directors of the Company, as constituted from time to time. 

        (b)   "Change in Control" shall mean: 

	(i)
	The
consummation of a merger or consolidation of the Company with or into another entity or any other corporate reorganization, if persons who were less than majority stockholders of
the Company immediately prior to such merger, consolidation or other reorganization own immediately after such merger, consolidation or other reorganization 50% or more of the voting power of the
outstanding securities of each of (A) the continuing or surviving entity and (B) any direct or indirect parent corporation of such continuing or surviving entity; or

	(ii)
	The
sale, transfer or other disposition of all or substantially all of the Company's assets. 

A
transaction shall not constitute a Change in Control if its sole purpose is to change the state of the Company's incorporation or to create a holding company that will be owned in substantially the
same proportions by the persons who held the Company's securities immediately before such transaction. 

        (c)   "Code" shall mean the Internal Revenue Code of 1986, as amended. 

        (d)   "Committee" shall mean a committee of the Board of Directors, as described in Section 2(21). 

        (e)   "Company" shall mean Amphastar Pharmaceuticals, Inc., a Delaware corporation. 

        (f)    "Consultant" shall mean a person who performs bona fide services for the Company, a Parent or a Subsidiary as a
consultant or advisor, excluding Employees and Outside Directors. 

10

 

        (g)   "Disability" shall mean that the Optionee is unable to engage in any substantial gainful activity by reason of any
medically determinable physical or mental impairment. 

        (h)   "Employee" sha1l mean any individual who is a common-law employee of the Company, a Parent or a Subsidiary. 

        (i)    "Exercise Price" shall mean the amount for which one Share may be purchased upon exercise of an Option, as specified by
the Committee in the applicable Stock Option Agreement. 

        (j)    "Fair Market Value" shall mean, as of any date, the value of the Stock determined as follows: 

	(i)
	If
the Stock is listed on any established stock exchange or traded on the Nasdaq National Market or the Nasdaq SmallCap Market, the Fair Market Value of a share of Stock shall be the
closing sales price for such stock (or the closing bid, if no sales were reported) as quoted on such exchange or market (or the exchange or market with the greatest volume of trading in the Stock) on
the last market trading day prior to the day of determination, as reported in The Wall Street Journal or such other source as the Board deems reliable.

	(ii)
	In
the absence of such markets for the Stock, the Fair Market Value shall be determined in good faith by the Board. Such determination shall be conclusive and binding on all persons. 

        (k)   "Immediate Family" shall mean any child, stepchild, grandchild, parent, stepparent, grandparent, spouse, sibling, mother-
in-law, father- in-law, son- in-law, daughter-in-law, brother-in-law or
sister-in-law and shall include adoptive relationships. 

        (I)   "ISO" shall mean an employee incentive stock option described in Section 422(b) of the Code. 

        (m)  "Nonstatutory Option" shall mean a stock option not described in Sections 422(b) or 423(b) of the Code. 

        (n)   "Option" shall mean an ISO or Nonstatutory Option granted under the Plan and entitling the holder to purchase Shares. 

        (o)   "Optionee" shall mean a person who holds an Option. 

        (p)   "Outside Director" shall mean a member of the Board of Directors who is not an Employee. 

        (q)   "Parent" shall mean any corporation (other than the Company) in an unbroken chain of corporations ending with the
Company, if each of the corporations other than the Company owns stock possessing 50% or more of the total combined voting power of all classes of stock in one of the other corporations in such chain.
A corporation that attains the status of a Parent on a date after the adoption of the Plan shall be considered a Parent commencing as of such date, 

        (r)   "Plan" shall mean this Amphastar Pharmaceuticals, Inc. Amended 2002 Stock Option/Stock Issuance Plan, 

        (s)   "Purchase Price" shall mean the consideration for which one Share may be acquired under the Plan (other than upon
exercise of an Option), as specified by the Board of Directors, 

        (t)    "Purchaser" shall mean a person to whom the Committee Ins offered the right to acquire Shares under the Plan (other than
upon exercise of an Option). 

        (u)   "Service" shall mean service as an Employee, Outside Director or Consultant. 

        (v)   "Share" shall mean one share of Stock, as adjusted in accordance with Section 8 (if applicable), 

        (w)  "Stock" shall mean the Common Stock of the Company. 

        (x)   "Stock Option Agreement" shall mean the agreement between the Company and an Optionee that contains the terms, conditions
and restrictions pertaining to the Optionee's Option, 

        (y)   "Stock Purchase Agreement" shall mean the agreement between the Company and a Purchaser who acquires Shares under the
Plan that contains the terms, conditions and restrictions pertaining to the acquisition of such Shares. 

        (z)   "Subsidiary" shall mean any corporation (other than the Company) in an unbroken chain of corporations beginning with the
Company, if each of the corporations other than the last corporation in the unbroken chain owns stock possessing 50% or more of the total combined voting power of all classes of stock in one of the
other corporations in such chain, A corporation that attains the status of a Subsidiary on a date after the adoption of the Plan shall be considered a Subsidiary commencing as of such date. 

11

 

SECTION 13.    Execution.  

        To record the adoption of the Plan by the Board of Directors, the Company has caused its authorized officer to execute the same. 

	 	 	Amphastar Pharmaceuticals, Inc.
	

 	
 	

 	

 
	

 	
 	

By:	

/s/  JACK ZHANG      
 Jack Zhang
	

 	
 	

Title:	

CEO/President

	

 	
 	

Date:	

July 15, 2004

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Exhibit 10.1QuickLinks
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Exhibit 10.4    
    

ASSET SALE AGREEMENT  

Made
as of the 26th day of June, 2003. 

BETWEEN:

AMPHASTAR PHARMACEUTICALS, INC.,

a company incorporated under the laws

of California,

having its principal office at

11570 Sixth Street

Cucamonga, CA 91730

(hereinafter referred to as the "Purchaser") 

and 

ORGANON USA INC.

a company incorporated under

the laws of the State of New Jersey,

having its principal office at

375 Mt. Pleasant Ave.

West Orange, NJ 07052

(hereinafter referred to as the "Seller") 

        WHEREAS, the Seller is the owner of the trademark, internet names and NDA (defined below) used in the manufacturing, packaging,
distributing and selling of the Product (defined below); 

        WHEREAS, the Seller desires to sell and assign to the Purchaser all of its right, title and interest in certain assets as defined in this
Agreement, subject to the terms and conditions of this Agreement; and 

        WHEREAS, after the Closing Date (defined below) the Purchaser desires to purchase from the Seller the Product, which shall be manufactured
by the Seller pursuant to a license from the Purchaser; 

        NOW, THEREFORE, in consideration of the rights and obligations contained herein, the parties agree as follows: 

1.    DEFINITIONS AND OTHER MATTERS    

        1.1    Definitions    

        For
the purposes of this Agreement, the following words shall have the following meanings unless the context requires otherwise: 

        1.1.1 "Active Pharmaceutical Ingredient" shall mean the drug substance cosyntropin manufactured by Diosynth BV or its
affiliates; 

        1.1.2 "Bill of Sale" shall mean the Bill of Sale in substantially the form of Exhibit A. 

        1.1.3 "Books and Records" shall mean (a) all books, records and recorded information, including customer and supplier
lists, held in Seller's name exclusively related to the Product as of the Closing, if any (b) laboratory books, batch records for the Product lots still in the market, stability summary and
clinical studies and regulatory files, if any, related to the Product, and (c) documents for manufacturing process, specifications, in process controls, and test methods for the Active
Pharmaceutical Ingredient, in process control and finished Product; 

        1.1.4 "Closing" shall mean the closing of the sale of the Purchased Assets, which shall take place on June 26, 2003
(the "Closing Date"); 

        1.1.5 "FDA" shall mean the U.S. Food and Drug Administration; 

 

        1.1.6 "Internet Names" shall mean the web addresses and domain names held in Seller's name in each case as set forth in
Schedule 3.3, and the applications and registrations therefor, if any; 

        1.1.7 "knowledge" of the Seller shall mean the actual conscious awareness of the management of the Seller; 

        1.1.8 "Trademark" shall have the meaning ascribed to this term in Subsection 3.3.1; 

        1.1.9 "Marketing Materials" shall mean all marketing materials, marketing research data, customer and sales information,
product literature, promotional materials and data, advertising and display materials and all training materials in whatever medium (e.g., audio, visual or print) held in Seller's name and exclusively
related to the Product or the Purchased Assets as of the Closing, if any; 

        1.1.10 "New Drug Application" or "NDA" shall mean the application (U.S. NDA
Number 16-750) for the Product prepared pursuant to applicable FDA regulations for filing with the FDA for authorization to market the Product within the United States, including all
additions, supplements, extensions and modifications thereto; 

        1.1.11 "Product" shall mean the Cortrosyn® injection, which contains Active Pharmaceutical Ingredient, for the
indication as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency in finished dosage form without diluent, which is the subject of the NDA; 

        1.1.12 "Product Inventories" shall have the meaning ascribed to this term in Section 3.2; 

        1.1.13 "Product Rights" shall have the meaning ascribed to this term in Section 3.1; 

        1.1.14 "Purchased Assets" shall have the meaning ascribed to this term in Article 3; 

        1.1.15 "Quality Agreement" means the Quality Agreement between the parties in the form of Exhibit B. 

        1.1.16 "Purchase Price" means the amount payable by the Purchaser to the Seller for the Purchased Assets, as set out in
Article 4; 

        1.1.17 "Regulatory Documentation" shall mean all (a) regulatory filings and supporting documents, chemistry and
manufacturing and controls data and documentation, preclinical and clinical studies and tests; (b) records maintained under record keeping or reporting requirements of the FDA or any other
governmental entity including without limitation the drug master file and Investigational New Drug application; and (c) the complete complaint, adverse event and medical inquiry filings with
respect to the Product; in each case held in the Seller's name and in each case exclusively related to the Product or the Purchased Assets; 

        1.1.18 "Regulatory Approvals" means, as they relate exclusively to the Product, and to the extent owned by Seller in the
Territory; the NDA; 

        1.1.19 "Required Notices" shall have the meaning ascribed to this term in Section 10.1; 

        1.1.20 "Security Agreement" means the Security Agreement between the parties in the form of Exhibit C; 

        1.1.21 "Technical Information" means all information, data, drawings, formulas, inventions, improvements, copyrights and
know-how, whether considered as trade secrets or not, related to the Product or the Purchased Assets, including, without limitation, complete manufacturing information, including, but not
limited to, information on components used for manufacturing with product numbers and suppliers, marketing, testing and customer information, copies of existing master production work orders, master
packaging work orders, manufacturing batch records up to 

2

 

and
including the last three production batches of the Product, stability data establishing current expiration dates for the Product, and current analytical test methods; 

        1.1.22 "Territory" means the United States of America and its respective territories and possessions; and 

        1.1.23 "Toll Agreement" means the Toll Manufacturing Agreement between the parties in the form of Exhibit D. 

        1.2    Schedules    

        The
schedules which are attached to this Agreement are incorporated into this Agreement by reference and are deemed to be part hereof: 

	Schedule
 
	 	Description

	3.2	 	Description of Product
	3.3	 	Inventories Internet Names
	11.1	 	Required Notices

        1.3    Applicable Currency    

        Except
as otherwise stated herein, all amounts payable under this Agreement shall be in U.S. dollars. 

        1.4    Applicable Law    

        This
Agreement shall in all respects be governed by and construed in accordance with the laws of the State of New Jersey and the federal laws of the United States applicable therein
without regard to the principles of conflict of laws. 

        1.5    Interpretation not Affected by Headings or Party Drafting    

        The
division of this Agreement into articles, sections and subsections and the insertion of headings are for convenience of reference only and shall not affect the construction or
interpretation of this Agreement. The terms "this Agreement", "hereof', "herein", "hereunder" and similar expressions refer to this Agreement and the schedules hereto and not to any particular
article, section or subsection or other portion hereof. Each party acknowledges that it and its legal counsel have reviewed and participated in settling the terms of this Agreement, and the parties
hereby agree that any rule of construction to the effect that any ambiguity is to be resolved against the drafting party shall not be applicable in the interpretation of this Agreement. 

        1.6    Number and Gender    

        In
this Agreement, unless there is something in the subject matter or context inconsistent therewith, (i) words in the singular number include the plural and such words shall be
construed as if the plural had been used, (ii) words in the plural include the singular and such words shall be construed as if the singular had been used, and (iii) words importing the
use of any gender shall include all genders where the context or party referred to so requires, and the rest of the sentence shall be construed as if the necessary grammatical and terminological
changes had been made. 

        1.7    Severability    

        If
any provision of this Agreement shall for any reason be held to be excessively broad as to duration, scope, activity, subject matter or otherwise, such provision shall be construed by
limiting and reducing it so as to be enforceable to the extent compatible with any applicable laws. If, notwithstanding the foregoing, any provision of this Agreement shall for any reason be held to
be invalid, illegal or unenforceable in any respect, then such invalid, illegal or unenforceable provision shall be severable and severed from this Agreement and the other provisions of this Agreement
shall 

3

 

remain
in effect and be construed as if such invalid, illegal or unenforceable provision had never been contained herein. 

2.    PURCHASE OF ASSETS AND EXCLUSION OF LIABILITIES    

        2.1    Purchase of Assets    

        The
Seller intends to sell and the Purchaser intends to purchase the Purchased Assets. All the Purchased Assets shall be purchased in accordance with the terms and conditions set out in
this Agreement. 

        2.2    Exclusion of Liabilities    

        Except
as specifically set forth in this Agreement, the Purchaser shall not assume any liabilities of the Seller, its affiliates, licensees, distributors or agents or of any other person
in connection with the Purchased Assets or the Product or both. For more certainty, it is agreed that the Purchaser will have no liability for any of the following obligations or liabilities, whether
liquidated or unliquidated, or known or unknown, whether arising out of occurrences prior to, at or after the date hereof: (i) all liabilities existing up to the Closing Date, in respect of all
indebtedness of the Seller or its affiliates related to the Product to all persons; (ii) all product liability claims, and liabilities for warranty or product return claims relating to the
Product or any similar claims to the foregoing, sold by the Seller, its affiliates, licensees, distributors or agents prior to the Closing Date (except as stated in Article 6); (iii) any
liabilities relating to the failure of Seller or its affiliates to manufacture, test, label, package, store, handle or ship the Product in accordance with written specifications set forth in the NDA,
cGMP, any other applicable laws or regulations prior to the Closing Date (except as stated in Article 6); (iv) any liability to or in respect of any employees or former employees of
Seller or its affiliates under any agreement or plan; (v) any liability of Seller or its affiliates in respect of any tax; and (vi) any existing or future environmental claim against
Seller or its affiliates. 

3.    PURCHASED ASSETS: DELIVERABLES    

        On
the terms and subject to the conditions set forth in this Agreement, at the Closing the Seller shall sell and transfer to the Purchaser, and the Purchaser shall purchase from the
Seller all of the following (which are referred to in this Agreement as the "Purchased Assets"): 

        (i)    the
Product Rights, as described in Section 3.1 hereof; and 

        (ii)   the
Product Inventories as described in Section 3.2 hereof. 

        3.1    The Product Rights    

        The
following rights shall be purchased by the Purchaser from the Seller and shall collectively be referred to as the "Product Rights": 

        3.1.1 the
United States Trademark CORTROSYN, U.S. Trademark Registration No. 779,366 (herein referred to as the "Trademark"); 

        3.1.2 all
of Seller's rights in and to the NDA as defined in Section 1.1.10 along with a copy of the most recent master batch record for the Product; 

        3.1.3 all
of Seller's rights in and to the Internet Names; 

        3.1.4 copies
of Books and Records, Marketing Materials, Technical Information and Regulatory Documentation certified true and complete. 

        3.2    Product Inventories    

        The
Purchaser shall purchase the Product Inventories held by or for the Seller on the Closing Date as described in Schedule 3.2.

4

 

        3.3    Deliverables    

        At
the Closing, Seller shall deliver or cause to be delivered in each case executed by Seller, the Security Agreement, the Bill of Sale, the Toll Agreement, the Assignment of Trademark,
the Assignment of Internet Names, the Quality Agreement and the NDA transfer form. To the extent any of the foregoing require execution by Purchaser, then they shall also be deliverables of the
Purchaser. 

        In
addition, no later than 5 working days after the Closing, the Seller shall deliver or cause to be delivered to Purchaser at its executive offices noted below copies of the Books and
Records, Marketing Materials, Technical Information and Regulatory Documentation. 

        3.4    Risk of Loss    

        Until
delivered to the Buyer on or after the Closing, any loss of or damage to the Purchased Assets from fire, casualty or any other occurrence shall be the sole responsibility of
Seller. 

4.    PURCHASE PRICE AND PAYMENT FOR PURCHASED ASSETS    

        4.1    Price of Product Rights    

        The
Purchaser shall pay to the Seller for the purchase of the Product Rights $28,000,000.00 payable by bank wire transfer as follows: 

        (a)   $16 million
at the Closing; 

        (b)   $6 million
on the first anniversary of the Closing Date; and 

        (c)   $6 million
the second anniversary of the Closing Date. 

Seller's
wire transfer instructions are as follows: 

Account
name: Akzo Nobel Inc. 

Account
number: 8090492730 

ABA
Number: 021000018 

Bank
Name: The Bank of New York 

Bank
Address: New York, NY 

Reference:
Organon USA Inc. 

        The
payments provided for in clauses 4.1(b) and 4.l(c) will be secured as provided in the Security Agreement. Any amount not paid when due shall thereafter bear interest at the rate of
10% per annum. 

        4.2    Price of Product Inventory    

        Pursuant
to section 3.2, the Purchaser shall pay to the Seller for the purchase of the Seller's Product Inventories the price specified in  Schedule 3.2, payable at Closing by bank wire transfer
according to the wire transfer instructions set forth in Section 4.1. 

        4.3    Taxes and Purchase Price Allocation    

        4.3.1 The
Purchaser shall bear and pay, and shall reimburse the Seller for any federal, state and local sales taxes, use taxes, transfer taxes, documentary charges,
recording fees, filing fees or similar taxes, charges, fees or expenses that may become payable in connection with the sale of the Purchased Assets to the Purchaser. 

        4.3.2 The
parties shall mutually agree in writing on the allocation of the purchase price for income tax purposes within 90 days of the date hereof, which allocation
in all events shall comply with 

5

 

applicable
requirements of the Internal Revenue Code and any regulations promulgated thereunder. The agreed upon allocation will be conclusive and binding upon the parties for tax purposes, and
neither party, nor its affiliates, agents, or representatives, shall make any statement or declaration to any taxing authority, on any tax return, or in any tax proceeding that is inconsistent with
the allocation, unless otherwise required by law. Each party shall promptly provide the other party with any additional information required to complete US Internal Revenue Service Form 8594. 

5.    MANUFACTURING OF PRODUCT AND SUPPLY OF ACTIVE PHARMACEUTICAL INGREDIENT BY THE SELLER AFTER THE CLOSING
DATE    

        5.1    Licenses    

        The
Purchaser hereby grants the Seller a royalty free, non-assignable, non-exclusive license to use the NDA in connection with the manufacture of the Product
exclusively for the Purchaser and its affiliates and any other party designated by the Purchaser in writing (but to no other party), effective on and after the Closing Date in accordance with the Toll
Agreement. The Purchaser hereby further grants Diosynth Inc. and its affiliates a royalty free, non-assignable, non-exclusive license to use the NDA solely in connection
with the supplying exclusively to the Purchaser and its affiliates and any other party designated by the Purchaser in writing (but to no other party) of the active pharmaceutical ingredient, effective
on and after the Closing Date. 

        5.2    Manufacturing: Price    

        Subject
to the Toll Agreement, the Seller shall manufacture the Product after the Closing and shall be responsible for testing the stability of the Product manufactured by the Seller.
The Seller's obligation to manufacture the Product shall terminate on the third anniversary of the Closing Date; provided that such obligation may be terminated upon six months' written notice from
the Purchaser to the Seller. The Seller shall sell the Product to the Purchaser at the price of $2.70 per each vial, subject to adjustment as provided in section 3.1 of the Toll Agreement. 

        Notwithstanding anything herein to the contrary, the Seller retains all rights to manufacture (including, but not limited to the use of the manufacturing process
and testing methods set forth in the NDA), use and sell Product for sale outside the Territory by its affiliates, and to use "Cortrosyn" in connection with such sales, provided in each such case the
Product is approved in each such country on the date hereof.

        For avoidance of doubt, the Seller shall not sell any Product to any party (other than the Purchaser, its affiliates and designees) in the Territory or to any
party outside the Territory for sale, distribution, or delivery into the Territory nor manufacture the Product for any party other than the Purchaser, its affiliates or designees, for sale of the
PRODUCT in the Territory.

        5.3    Supply of Active Pharmaceutical Ingredient    

        The
Seller will cause Diosynth Inc. or its affiliates to supply to the Purchaser and its affiliates and any other party designated by the Purchaser in writing (but to no other
person) the Active Pharmaceutical Ingredient for the manufacture and sale of Product in the Territory until the fifth anniversary of the Closing Date at a price equal to $180.00 per gram. At Closing,
Purchaser shall provide a firm purchase order for Active Pharmaceutical Ingredient for each of the first 3 years after the Closing Date. In the event Purchaser does not order sufficient Product
from Seller under the Toll Agreement to use all such Active Pharmaceutical Ingredient, Purchaser shall purchase such remaining Active Pharmaceutical Ingredient from seller on the third anniversary of
the Toll Agreement at the above price. On the second anniversary of the Closing Date, Purchaser shall give a firm order for Active Pharmaceutical Ingredient for years 4 and 5. 

6

 

6.    RETURNS. RECALLS AND REBATES    

        6.1    Returns    

        Effective
as of the Closing Date, the Purchaser agrees to accept all returns of the Product, including Product sold by the Seller to customers prior to the Closing Date, and all
responsibilities associated therewith, except for any receivables, payables or credits related to returned Product that were sold or distributed by the Seller before the Closing Date. The Purchaser
shall not assume any responsibility with regard to receivables, payables or credits unless they relate to returned Product ordered from and sold by the Purchaser on or after the Closing Date, other
than to provide notice to the Seller of any such returns, including any correspondence or requests relating to the returns, and any request for reimbursement, payment or credit, as the case may be.
Following the Closing, the parties will jointly issue a letter to customers for the Product, advising such customers of each party's respective responsibilities in connection with returns and credits.
At no time before or after the Closing will the Seller actively solicit customers to return Product absent any safety or efficacy issues. 

        6.2    Recalls    

        In
the event of a Product recall, the Purchaser shall be responsible for recovering Product distributed by it. The Seller shall reimburse the Purchaser for the Purchaser's reasonable
out-of-pocket expenses, upon presentation to the Seller by the Purchaser of appropriate documentation therefor, for such recovery in connection with sales of the Product
constituting part of the Purchased Assets. The Purchaser shall be entitled to return to the Seller such Product constituting part of the Purchased Assets for a refund from the Seller equal to the
price paid by the Purchaser for such Product. If the Purchaser becomes aware of the need for a recall of the Product sold by the Seller to the Purchaser, the Purchaser shall notify the Seller not less
than three days thereafter and shall consult with the Seller concerning such recall, but the Purchaser shall not initiate any recall without the Seller's prior written consent, except as required by
law. 

        6.3    Rebates; Chargebacks    

        Seller
agrees to be responsible for all rebates and chargebacks which arose or accrued due to the sale of the Product which occurred on or prior to the Closing Date. 

7.    COSTS AND EXPENSES OF THE TRANSACTION    

        Except
as otherwise provided herein, each party shall pay its own expenses incurred in connection with the authorization, preparation, execution and performance of this Agreement,
including, without limitation, all fees and expenses of its legal counsel, employees, agents and representatives. 

8.    REPRESENTATIONS AND WARRANTIES OF THE SELLER    

        As
of the Closing Date, the Seller hereby represents and warrants as follows and hereby acknowledges and confirms that the Purchaser is relying on such representations and warranties in
connection with its entering into this Agreement: 

        8.1   the Seller is a corporation duly organized, validly existing and in good standing under the laws of the State of New
Jersey; Seller is duly authorized to conduct its business and is in good standing in each jurisdiction where such qualification is required except for any jurisdiction where failure to so qualify
would not have a material adverse effect upon the Seller; Seller has the full power and authority and holds all permits and authorizations to manufacture, market and sell the Product, to own and use
the assets and properties owned by it, including the Purchased Assets, except where the failure to have such power and authority or to hold such permits and authorizations would not have a material
adverse effect on Seller or the Purchased Assets; 

        8.2   the execution and delivery of this Agreement by the Seller and the observance and performance of the terms of this
Agreement on the part of the Seller, including the execution and 

7

 

delivery
of the related agreements, assignments, instruments and documents, have been duly authorized by all necessary corporate action of the Seller, and do not constitute a violation of applicable
laws or a violation or a breach of the Seller's charter documents or by-laws, or any order, writ, injunction, decree, rule or by-law or regulation applicable to it, nor do they
constitute a default (or would with the passage of time or the giving of notice or both constitute a default) under any contract or instrument to which the Seller is a party or by which the Seller is
bound. The Required Notices are the only consents or approvals required in connection with the sale of the Purchased Assets by the Seller to the Purchaser asset forth herein. This Agreement and all
other related agreements, assignments and instruments executed by Seller hereunder, shall when executed by Purchaser, be valid and binding obligations of Seller enforceable against Seller in
accordance with their terms except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditor's
rights generally, and (b) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies; 

        8.3   the Seller is not a party to or bound by any mortgage, lien, deed of trust, or any material lease, agreement or
instrument, or any order, judgment or decree which requires the consent of another to the execution of this Agreement, to transfer the Purchased Assets or fully give effect to any of the transactions
referred to in or contemplated by this Agreement; 

        8.4   the Seller is the owner of all Purchased Assets, with good and marketable title thereto, free of any claim, lien,
security interest, charge, mortgage, option, privilege, pledge, trust or deemed trust (whether contractual, statutory or otherwise arising) or any encumbrance; 

        8.5   Seller has not received notice of any suits, actions or legal, administrative, arbitration or other proceedings or,
governmental investigations pending, or to the Seller's knowledge threatened, affecting the Purchased Assets or the right to manufacture, market, distribute, offer to sell or sell the Product in the
Territory and, to the Seller's knowledge, no such suits, actions or legal, administrative, arbitration or other proceedings or governmental investigations affecting the Purchased Assets or the right
to sell the Product have been threatened against the Seller; 

        8.6   the NDA is in full force and effect and, to the Seller's knowledge, has been duly and validly issued. Seller has not
received notice of any proceeding by any governmental or regulatory authority pending, nor, to the Seller's knowledge, is any governmental or regulatory authority threatening a Product recall, market
withdrawal, or the revocation or suspension of the NDA. Except as set forth herein or in correspondence between the parties dated the date hereof, all required notices, supplemental applications, and
annual or other reports, including adverse experience reports, with respect to the NDA which are required to maintain the NDA in good standing have been filed with the FDA and the copies of such
documents delivered to the Purchaser at closing are true and correct; 

        8.7   to the Seller's knowledge, as of the Closing Date, the production, manufacture and sale of the Product in the Territory
does not, to the knowledge of the Seller, infringe any third party's intellectual property rights, and the Seller has not received any notice, complaint, threat or claim concerning the Product
alleging infringement of any patent or trademark, of any other person; 

        8.8   the Seller has not allowed or acquiesced in the use of the Trademark in the Territory by any other person. To the best of
Seller's knowledge, the Trademark is distinctive and is not confusing with any other trade mark or trade name. The Seller has taken all commercially reasonable steps to vigilantly protect the
distinctiveness of the Trademark. The U.S. trademark registration is valid, in good standing and is not the subject of any expungement proceedings. To Seller's knowledge, the use of the Trademark does
not constitute infringement of any person's common law or statutory trade mark rights and the Seller is not aware of any infringement or passing off relating to the Trademark. 

8

 

        8.9   the Seller is not a party to or bound by any executory agreement, contract or commitment, whether written or oral,
relating to the sale of the Product, which is not referred to in this Agreement or any Schedule hereto and of which the Purchaser was not remitted complete and correct copies (including all
amendments) before the Closing Date; 

        8.10 no representation or warranty made by the Seller in this Agreement contains any untrue statement of a material fact or
omits to state any material fact necessary to make any such representation or warranty not misleading to a prospective purchaser seeking full information as to the Seller, the Product and the
Purchased Assets; 

        8.11 EXCEPT AS EXPRESSLY STATED HEREIN, THE SELLER MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, RELATED TO THE ACTIVE PHARMACEUTICAL INGREDIENT OR PRODUCT INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. THE
PURCHASER ACKNOWLEDGES THAT THE ACTIVE PHARMACEUTICAL INGREDIENT AND, PRODUCT INVENTORY ARE SOLD ON AN AS-IS, WHERE-IS BASIS.

9.    REPRESENTATIONS AND WARRANTIES OF THE PURCHASER    

        As
of the Closing Date, the Purchaser hereby represents and warrants as follows and hereby acknowledges and confirms that the Seller is relying on such representations and warranties in
connection with the entering into this Agreement: 

        9.1   the Purchaser is a corporation duly organized, validly existing and in good standing under the laws of California; is
duly authorized to conduct its business and is in good standing in each jurisdiction where such qualification is required except for any jurisdiction where failure to so qualify would not have a
material adverse effect upon the Purchaser; Purchaser has the full power and authority, and holds all permits and authorizations, to carry on its business and to own and use the assets and properties
owned by it, except where the failure to have such power and authority or to hold such permits and authorizations would not have a material adverse effect on Purchaser; 

        9.2   the execution and delivery of this Agreement by the Purchaser and the observance and performance of the terms of this
Agreement on the part of the Purchaser, including the execution and delivery of the related agreements, assignments, instruments and documents, have been duly authorized by all necessary corporate
action of the Purchaser except where failure to obtain such authorization is not material, and do not constitute a violation of applicable laws or a violation or a breach of the Purchaser's charter
documents or by-laws, or any order, writ, injunction, decree, rule, by-law or regulation applicable to it, nor do they constitute a default (or would with the passage of time
or the giving of notice or both constitute a default) under any contract or instrument to which the Purchaser is a party or by which the Purchaser is bound. This Agreement and all other related
agreements, assignments and instruments executed by Purchaser hereunder, shall when executed by Seller, be valid and binding obligations of Purchaser enforceable against Purchaser in accordance with
their terms except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditor's rights generally,
and (b) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies; 

        9.3   the Purchaser is not a party to or bound by any mortgage, lien, deed of trust, or any material lease, agreement or
instrument, or any order, judgment or decree which requires the consent of another to the execution of this Agreement or fully give effect to any of the transactions referred to in or contemplated by
this Agreement; and 

9

 

        9.4   there are no suits, actions or legal, administrative, arbitration or other proceedings or, to the Purchaser's knowledge,
governmental investigations affecting this Agreement and, to the Purchaser's knowledge, no such suits, actions or legal, administrative, arbitration or other proceedings or governmental investigations
have been threatened against the Purchaser. 

10.    COVENANTS OF THE PARTIES    

        10.1 Notwithstanding anything to the contrary contained in this Agreement, the Seller shall retain and remain solely
responsible for all risks, liabilities and costs related to the Product manufactured and sold by the Seller prior to the Closing Date or based solely on a defective manufacture of Product by the
Seller or defect in the Active Pharmaceutical Ingredient supplied by Diosynth or its affiliates pursuant to Article 5 and the Toll Agreement, or the manufacture, marketing, offer for sale or
sale of the Product outside of the Territory or the use of Cortrosyn outside of the Territory, and shall indemnify the Purchaser as provided for in article 12. 

10

   
        10.2     Notwithstanding anything to the contrary contained in this Agreement but subject to Section 10.1,
the Purchaser shall retain and remain solely responsible for all risks, liabilities and costs related to the Product or Active Pharmaceutical Ingredient, including, but not limited to, those arising
from or relating to the manufacturing, use, distribution, marketing, promotion, offer for sale, or sale of the Product or Active Pharmaceutical Ingredient by the Purchaser on and after the Closing
Date, and shall indemnify the Seller as provided for in article 12 except that the Seller shall assume such risks based solely on a defective manufacturing process of Product by the Seller
pursuant to Article 5. 

        10.3     The Seller agrees that, on and after the Closing Date, it will neither disclose the Technical Information
to any person other than the Purchaser nor utilize the Technical Information for its own purposes, except in manufacturing pursuant to article 5 and except as set forth in Section 11.5
relating to Ongoing Stability Studies. The Seller shall keep and use reasonable efforts to require its personnel to keep confidential all confidential information transferred herein and the Technical
Information, according to guidelines substantially similar to those used to protect its own confidential information, including, without limitation, written material, drawings, data (whether on paper,
electronic support or any other support), records or reports regarding the Purchased Assets. 

        Such
restriction shall not apply to any information (i) which is in or comes into the public domain through no fault of the Seller, (ii) which was in the possession of the
Purchaser before the commencement of negotiations leading to this Agreement, as evidenced by such party's written records, (iii) which, at any time, lawfully comes into the possession of the
Purchaser from third parties that have a right to disclose such information or (iv) which is required to be disclosed by law. 

        The
Purchaser acknowledges and agrees that the above restriction on confidential information shall in no way limit or restrict the Seller's right to in any way use any confidential
information that is (i) incorporated into, embodied in or used in connection with current or future products or processes of the Seller or its affiliates, other than the Product, or
(ii) used in the research, development, registration, promotion, testing, marketing, distribution or sale of products or processes of the Seller or its affiliates, other than the Product. 

        10.4     The Seller agrees that it shall not (i) directly or indirectly, at any time after the Closing Date,
in any manner, question the rights of the Purchaser under the Trademark, or (ii) use or register, or authorize at any time the use of registration, of any trademark or trade name identical with
or confusingly similar to the Trademark in the Territory. 

        10.5     The Seller shall cooperate in changing the labeling on the Product to the Purchaser's label promptly after
the Closing Date. If practicable, batches of the Product shall be unlabelled prior to the Closing Date, to facilitate using the Purchaser's label on the Closing Date and thereafter. 

        10.6     The Seller shall, at any time before and after the Closing Date and upon reasonable request, provide the
Purchaser and its representatives with such additional information or documentation, except for auditors' reports, concerning the Product as may be reasonably necessary for inclusion by the Purchaser
in any necessary filing or submission to any governmental agency in order to continue the commercial exploitation of the Purchased Assets. 

        10.7     Except as contemplated herein and in the Toll Agreement, Seller agrees that for a period commencing at
Closing and ending seven (7) years later, neither it nor any of its affiliates (including Diosynth) shall develop, manufacture, market, distribute or sell a product, either for prescription or
over-the-counter sale, containing the Active Pharmaceutical Ingredient, for use in diagnosing primary or secondary adrenocortical insufficiency in the Territory. 

11

 

11.    CERTAIN ACTIONS SUBSEQUENT TO THE CLOSING DATE    

        The
parties agree to take the following actions subsequent to the Closing Date: 

        11.1    Regulatory Affairs    

        As
of the Closing Date, the Purchaser shall assume the responsibility for maintaining the registrations of the Products in the Territory at its own cost. The Seller shall assist the
Purchaser in the transfer of all applicable Regulatory Approvals. To that effect, the Seller shall send to the FDA and other persons, as required, any required notice relative to the transfer of
ownership of the Purchased Assets; such required notices are set forth on Schedule 11.1 (the "Required Notices"). The Seller shall thereafter
provide all information and make all further filings as may be reasonably requested by the Purchaser in order for the Purchaser to confirm and perfect the ownership of the Purchaser in and to the
Purchased Assets. 

        11.2    Customer Complaints    

        Customer
complaints for Product sold or distributed by the Seller prior to the Closing Date shall be handled by the Seller, including notification of regulatory authorities where
required, with a copy to the Purchaser. Customer complaint for Product sold or distributed on and after the Closing Date shall be the exclusive responsibility of the Purchaser. 

        11.3    Third Party Claims    

        Third
party claims related to the Product manufactured, sold or distributed by the Seller or its affiliates, distributors, licensees or agents prior to the Closing Date or related to the
Product manufactured, sold or distributed by the Seller or its affiliates, distributors, licensees or agents outside of the Territory or solely based on a defective manufacturing process of Product by
Seller or defect in the Active Pharmaceutical Ingredient supplied by Diosynth or its affiliates pursuant to Article 5 and the Toll Agreement shall be the responsibility of the Seller and the
Seller shall indemnify, defend and hold the Purchaser and its affiliates harmless from and against any liability related thereto to the extent set forth in article 12. Any third party claims
related to the Purchased Assets or Product arising on and after the Closing Date other than liability based solely on a defective manufacturing process of Product by Seller or defect in the Active
Pharmaceutical Ingredient supplied by Diosynth or its affiliates pursuant to Article 5 and the Toll Agreement shall be the exclusive responsibility of the Purchaser, and the Purchaser shall
indemnify, defend and hold the Seller harmless from and against any liability related thereto as set forth in article 12. 

        11.4    Adverse Drug Experiences    

        Any
new adverse drug experiences reported to the Seller on or after the Closing Date for Product distributed or sold by the Seller prior to the Closing Date or manufactured pursuant to
Article 5 shall promptly be communicated by the Seller to the Purchaser. The Purchaser will be responsible for any reporting to any governmental authorities of any new adverse drug experiences
reported to the Seller and communicated by the Seller to the Purchaser for Product distributed or sold prior to the Closing Date. Any adverse drug experiences related to Product distributed or sold on
and after the Closing Date other than relating solely to a defective manufacturing process of the Product by the Seller or defect in the Active Pharmaceutical Ingredient supplied by Diosynth or its
affiliates pursuant to Article 5 and the Toll Agreement, which shall be the exclusive responsibility of Seller, shall be the exclusive responsibility of the Purchaser. 

        11.5    Further Assurances and Ongoing Stability Studies    

        Each
party shall cooperate with the other, and execute and deliver, or cause to be executed and delivered, all such other instruments, including instruments of conveyance, assignment and
transfer, and take all such other actions as such party may be reasonably requested to take by the other party from 

12

 

time
to time, consistent with the terms of this Agreement, in order to implement the provisions and purposes of this Agreement and vest in the Purchaser all right, title and interest in and to the
Purchased Assets. 

        The
parties acknowledge that the Seller has made commitments to the FDA to continue ongoing stability studies for the Product manufactured prior to the Closing Date and that these
commitments will continue for Product manufactured pursuant to Section 5.2. The Seller will continue these ongoing stability studies in accordance with its commitments to the FDA and will
report the findings to the Purchaser, which agrees to report the findings to any governmental authorites in accordance with applicable law. In order to continue these ongoing stability studies, the
Seller will maintain and use the stability samples of the Product which are currently being kept by the Seller for its stability program and will keep copies of the stability reports previously
reported to the FDA. In addition, the Seller will be able to withdraw and maintain stability samples for Product manufactured pursuant to Section 5.2. 

12.    SURVIVAL: INDEMNITIES: DAMAGES    

        12.1    Survival    

        The
representations and warranties in articles 8 and 9 shall survive the sale of the Purchased Assets and, notwithstanding the completion of such sale and notwithstanding any
investigations made by or on behalf of the parties, shall continue to have full force and effect for two years following the Closing Date, except Sections 8.1, 8.2, 8.3 and 8.4 which shall survive
indefinitely subject to applicable statutes. 

        12.2    Indemnification by Seller    The Seller shall indemnify and hold harmless the Purchaser and its stockholders,
directors, officers, employees, representatives and agents from and against any loss or damage of any kind suffered as a result of third party claims (i) arising from or based on the
manufacturing, use, distribution, marketing, promotion, offer for sale, or sale of any of the Product prior to the Closing Date or the Product outside of the Territory or based solely on a defective
manufacturing process of the Product by the Seller or defect in the Active Pharmaceutical Ingredient supplied by Diosynth or its affiliates pursuant to article 5 and the Toll Agreement (save
for any claim arising out of the intentional fault or negligence of the Purchaser); (ii) resulting from the Seller's breach of any representation, warranty or agreement made by the Seller in
this Agreement including, without limiting the generality of the foregoing, all costs, expenses and reasonable legal and accounting fees in connection with any such loss or damage and in connection
with any claim under this section 12.2. 

        12.3    Indemnification by Purchaser    

        The
Purchaser shall indemnify and hold harmless the Seller and its stockholders, directors, officers, employees, representatives and agents from and any loss or damage of any kind
suffered as a result of any third party claims (i) (other than any claim arising out of the intentional fault or negligence of the Seller) arising from or based on the manufacturing, use,
distribution, marketing, promotion, offer for sale, or sale of any of the Purchased Assets or the Product in the Territory on and after the Closing Date, except for claims relating solely to a
defective manufacturing process of the Product by the Seller or defect in the Active Pharmaceutical Ingredient supplied by Diosynth or its affiliates pursuant to article 5 and the Toll
Agreement; or (ii) resulting from the Purchaser's breach of any representation, warranty or agreement made by the Purchaser in this Agreement, including, without limiting the generality of the
foregoing, all costs, expenses and reasonable legal and accounting fees in connection with any such loss or damage and in connection with any claim under this section 12.3. 

        12.4    Notice and Defense of Claims    

        As
a condition to the indemnification in this article 12, any party seeking indemnification shall give prompt and, to the extent of known facts and circumstances, complete written
notice to the 

13

 

indemnifying
party of the facts and circumstances giving rise to the claim; provided that the failure to give timely notice to the indemnifying party shall not release the indemnifying party from any
liability to the indemnified party unless the ability of the indemnifying party to defend against such claim is materially and adversely affected thereby. In connection with any claim of a party
giving rise to indemnification hereunder, the indemnifying party, at its sole cost and expense, may, upon written notice to the indemnified party, assume and control the defense and disposition of any
such claim or related legal proceeding. If the indemnifying party assumes the defense of any such claim or legal proceeding, the indemnifying party shall select counsel to conduct the defense of such
claim or legal proceeding and at its sole cost and expense shall take all steps which it believes are appropriate in the defense or settlement thereof. The indemnified party shall be entitled to
participate in (but not control) the defense of any such claim with its own counsel and at its own expense, but shall not payor settle any such claim. The indemnified party shall cooperate with the
indemnifying party in the indemnifying party's defense of any such matter, including providing reasonable access at no cost to the indemnified party's employees, agents, records and facilities. The
indemnifying party shall not settle any claim the defense of which it controls unless the settlement is solely for money damages, or the indemnifying party obtains the prior written consent of the
indemnified party, which may not be unreasonably withheld. If the indemnifying party does not assume the defense of any such claim or proceeding resulting therefrom in accordance with the terms
hereof, the indemnified party may defend such claim or proceeding in a reasonable manner, including settling such claim or proceeding on such terms as the indemnified party may deem appropriate after
giving ten days' notice of the same to the indemnifying party and obtaining the consent of the indemnifying party, which may not be unreasonably withheld. 

        12.5    Limitation of Damages    

        In
no event, except in the case of third party claims, shall the Seller or the Purchaser be liable to the other for special, indirect, incidental or consequential damages (including,
without limitation, loss of profits) suffered by either the Seller or the Purchaser. 

13.    GENERAL CONTRACT PROVISIONS    

        13.1    Force Majeure    

        If
the performance of any part of this Agreement by either party (other than the obligation to pay money) is prevented, restricted, interfered with or delayed by reason of any cause
beyond the reasonable control of the party liable to perform, such as from fire, strike, delays in delivery of, or the unavailability of supplies or sources of energy, labor difficulties, act or
omission of any governmental authority, compliance with governmental regulations, insurrection or riot, embargo, delays or shortages in transportation or inability to obtain necessary materials,
supplies or labor, the party so affected shall, upon giving written notice to the other party, be excused from such performance to the extent of such prevention, restriction, interference or delay,
provided that the affected party shall continue to use its reasonable best efforts to avoid or remove such causes of nonperformance and shall continue performance with the utmost dispatch whenever
such causes are removed. If such cause is preventing the manufacture of either API or finished Product by Seller for Purchaser and is not removed within 90 days of its inception, then Purchaser
shall have the right to terminate the Seller's right to manufacture the finished Product immediately by written notice to that effect delivered to Seller. 

        13.2    Notices    

        All
notices in connection with this Agreement shall be in writing and either hand-delivered, mailed by registered or certified mail, postage prepaid, or sent by telecopier.
Any such notice shall be deemed to have been received on the date of the hand-delivery, if delivered by hand, on the fifth business day following the date of mailing if sent by registered
or certified mail or on the date shown on the 

14

 

telecopier
report slip if sent by telecopier. The mu:ties'respective addresses for the purpose of receiving such notices are as follows: 

	If to the Purchaser:	 	Amphastar Pharmaceuticals, Inc.

11570 Sixth Street

Rancho Cucamonga, CA 91730

Facsimile: 909-980-6139

Attention: Chief Financial Officer
	

If to the Seller:	
 	

Organon USA Inc.

375 Mt. Pleasant Ave.

West Orange, NJ 07052

Facsimile: 973-422-7287

Attention: Michael V. Novinski, President
	

With a copy to:	
 	

Organon USA Inc.

375 Mt. Pleasant Ave.

West Orange, NJ 07052

Attention: Patrick 1. Osinski, Vice President

and General Counsel

Facsimile: 973-325-4514

        Either
of the foregoing parties may, at any time, give notice of any change of address to the other and the address specified therein shall be such party's address for the purpose of
receiving notices. 

        13.3    No Broker    

        It
is understood and agreed that no broker, agent or other intermediary acted for either party in connection with the transactions contemplated herein and each party agrees to indemnify
and save harmless the other from and against any claims whatsoever for any commission or other remuneration payable or alleged to be payable to any broker, agent or other intermediary who purports to
act or have acted for the party in question. 

        13.4    Independent Contractors    

        This
is an Agreement between independent contractors and neither is the agent nor employee of the other for any purpose whatsoever. The parties do not intend to create a partnership or
joint venture
between themselves. Neither party shall have the right to bind the other to any agreement with a person or to incur any obligation or liability on behalf of the other party. 

        13.5    Counterparts    

        This
Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. 

        13.6    Assignment: No Third Party Beneficiaries    

        This
Agreement shall bind and inure to the benefit of the parties named herein and their respective successors and permitted assigns. No party may assign any rights, benefits, duties or
obligations under this Agreement without the prior written consent of the other party, except that (a) either party may assign its rights and obligations hereunder to an affiliate or to the
transferee or successor of substantiality all of its assets or securities in the event of a change of control without the prior consent of the other party; provided that in the case of an assignment
to an affiliate, the assigning party shall remain responsible for all of its obligations and agreements set forth herein, notwithstanding such assignment and, (b) the Purchaser may assign the
Agreement to a third party as security without 

15

 

the
consent of the Seller. No third party shall be entitled to enforce any provision hereof and no third party is intended to benefit from this Agreement. 

        13.7    Entire Agreement    

        This
Agreement, the Toll Manufacturing Agreement, the Quality Agreement and the Security Agreement shall constitute the entire agreement between the parties with respect to all of the
matters herein and shall supersede all prior oral or written agreements, understandings or arrangements between them. No amendment, modification, or discharge of this Agreement and/or waiver hereunder
shall be valid or binding unless set forth in writing and duly executed by an officer or authorized representative of the party against whom enforcement of the amendment, modification, discharge, or
waiver is sought. 

        IN
WITNESS WHEREOF, this Agreement has been executed on behalf of the parties by the following duly authorized representatives of the parties as ofthe date set forth above. 

	ORGANON USA INC.	 	AMPHASTAR PHARMACEUTICALS, INC.
	

By:	
 	

    
	
 	

By:	
 	

/s/

	Name: Patrick J. Osinski	 	Name: David W. Nassif
	Title: Vice President	 	Title: Chief Financial Officer and Senior Vice President of Blobal Licensing
	

By:	
 	

 	
 	

 	
 	

 
	 	 	
	 	 	 	 
	Name: Huib Costermans	 	 	 	 
	Title: Vice President

	 	 	 	 

16

 
SCHEDULE 3.2  

 Product Inventories  

        6,797 cartons of Product at $27.00 per carton 

17

 
SCHEDULE 3.3  

CORTROSYN.COM  

CORTROSYN.US  

18

 
SCHEDULE 11.1  

 Required Notices  

        Letter
to FDA 

19

 
EXHIBIT A  

BILL OF SALE  

June 26,
2003 

        For
$1 and other valuable consideration, receipt of which is hereby acknowledged, Organon USA Inc. hereby sells all of its rights, title and interest in the following assets to
Amphastar Pharmaceuticals, Inc.: 

	(a)
	New
Drug Application 16-750

	(b)
	U.S.
Trademark #779,399 for Cortrosyn®

	(c)
	The
internet names www.cortrosyn.com and www.cortrosyn.us

(d) 6,797 cartons of Cortrosyn® containing 10 vials per carton 

        In
witness whereof, a duly authorized officer of Organon has executed this Bill of Sale effective as of the date written above. 

	ORGANON USA INC.	 	 	 	 
	

By:	
 	

 	
 	

 	
 	

 
	 	 	Patrick J. Osinski

Vice President	 	 	 	 
	

By:	
 	

 	
 	

 	
 	

 
	 	 	Huib Costermans

Vice President	 	 	 	 

20

QuickLinks

Exhibit 10.4

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