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Exhibit 10.5    
    

SECURITY AGREEMENT  

        THIS
AGREEMENT, dated June 26, 2003, is by and between AMPHASTAR PHARMACEUTICALS, INC., a California corporation ("Debtor"), and
ORGANON USA INC., a New Jersey corporation ("Secured Party"). 

        WHEREAS,
pursuant to an Asset Sale Agreement dated June    , 2003, between Debtor and Secured Party (the "Sale Agreement"), Debtor has purchased from Secured Party, the United
States Trademark CORTROSYN, U.S. Trademark Registration No. 779,366 (the "Trademark") and the New Drug Application, U.S. NDA No. 16-750 (the "NDA"); and 

        WHEREAS,
to induce Secured Party to enter into the Sale Agreement, Debtor has agreed to grant to Secured Party certain collateral security as set forth herein; 

        NOW,
THEREFORE, in consideration of the premises and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Debtor and Secured Party
hereby agree as follows: 

        1.    GRANT OF SECURITY INTEREST    

        As
collateral security for the prompt performance, observance and indefeasible payment in full of all of the Obligations (as hereinafter defined), Debtor hereby grants to Secured Party a
continuing security interest in and a general lien upon the following (being collectively referred to herein as the "Collateral"): (a) all of Debtor's now existing or hereafter acquired right,
title, and interest in and to the Trademark and the NDA; (b) all income, fees, royalties and other payments at any time due or payable with respect thereto, including, without limitation,
payments under all licenses at any time entered into in connection with the Trademark and NDA therewith; (c) all reissues, extensions, continuations, renewals, supplements or amendments to the
Trademark or the NDA; (d) the right to sue for past, present and future infringements of the Trademark; and (e) all proceeds of any of the foregoing. 

        2.    OBLIGATIONS SECURED    

        The
security interest, lien and other interests granted to Secured Party pursuant to this Agreement shall secure the prompt performance, observance and payment in full of any and all
obligations, liabilities and indebtedness of every kind, nature and description owing by Debtor to Secured Party arising under this Agreement or the Sale Agreement, whether now existing or hereafter
arising, whether arising after the commencement of any case with respect to Debtor under the United States Bankruptcy Code or any similar statute (including, without limitation, the payment of
interest and other amounts which would accrue and become due but for the commencement of such case), all of the foregoing being collectively referred to herein as the "Obligations". 

        3.    REPRESENTATIONS. WARRANTIES AND COVENANTS    

        Debtor
hereby represents, warrants and covenants with and to Secured Party the following (all of such representations, warranties and covenants being continuing so long as any of the
Obligations are outstanding): 

        (a)   Debtor
shall pay and perform all of the Obligations according to their terms, 

        (b)   Debtor
has the right and power to grant the security interest granted hereunder. Debtor shall, at Debtor's expense, perform all acts and execute all documents necessary
to maintain the existence of the Trademark as a registered trademark and to maintain the existence of all of the Collateral as valid and subsisting, including, without limitation, the filing of any
renewal affidavits 

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and
applications. The Collateral is not subject to any liens, claims, mortgages, assignments, security interests or encumbrances of any nature whatsoever, except the security interests granted
hereunder. 

        (c)   Debtor
shall not assign, sell, mortgage, lease, transfer, pledge, hypothecate, grant a security interest in or lien upon, encumber, grant an exclusive or
non-exclusive license relating to the Collateral, or otherwise dispose of any of the Collateral, in each case without the prior written consent of Secured Party. Notwithstanding the
foregoing, Debtor may grant a subordinate security interest in the Collateral to a third party in connection with a financing without the consent of the Secured Party; provided that the third party
enters into an inter-creditor agreement acceptable to the Secured Party. 

        (d)   Debtor
shall, at Debtor's expense, promptly perform all acts and execute all documents requested at any time by Secured Party to evidence, perfect, maintain, record or
enforce the security interest in the Collateral granted hereunder or to otherwise further the provisions of this Agreement. Debtor hereby authorizes Secured Party to authenticate in the name of Debtor
and file one or more financing statements (or similar documents) with respect to the Collateral. Debtor further authorizes Secured Party to have this Agreement or any other similar security agreement
filed with the U.S. Patent and Trademark Office (the "PTO") or any other appropriate federal, state or government office. 

        (e)   Debtor
shall, concurrently with the execution and delivery of this Agreement, execute and deliver to Secured Party five (5) originals of a Special Power of
Attorney in the form of Annex A annexed hereto for the implementation of the sale or other disposition of the Collateral pursuant to Secured Party's
exercise of the rights and remedies granted to Secured Party hereunder; provided, however, Secured Party
hereby agrees that it will not exercise its rights under such Special Power of Attorney unless an Event of Default (defined below) has occurred and is continuing. 

        (f)    Secured
Party may, in its reasonable discretion, pay any amount or do any act which Debtor fails to pay or do as required hereunder or as requested by Secured Party to
preserve, defend, protect, maintain, record or enforce the Collateral or the security interest granted hereunder, including, but not limited to, all filing or recording fees, court costs, collection
charges, attorneys' fees and legal expenses. Debtor shall be liable to Secured Party for any such payment, which liability shall be part of the Obligations secured hereby. 

        (g)   Debtor
shall not do any act, nor omit to do any act, whereby the Trademark may become abandoned, invalidated, unenforceable, avoided, or avoidable, except for any such
act or omission that, individually or in the aggregate, shall not have resulted in, and could not reasonably be expected to result in, a material adverse effect on the Collateral. Debtor shall notify
Secured Party immediately if it knows or has reason to know of any reason why any application, registration, or recording with respect to the Trademark may become abandoned, canceled, invalidated,
avoided or avoidable. 

        (h)   Debtor
shall render any assistance, as Secured Party shall determine is necessary or advisable, to Secured Party in any proceeding before the United States Patent and
Trademark Office, any federal or state court, or any similar office or agency in the United States, any State thereof or any political subdivision thereof, to maintain the application and registration
of the Trademark as Debtor's exclusive property and to protect Secured Party's interest therein, including, without limitation, filing of renewals, affidavits of use, affidavits of incontestability
and opposition, and cancellation proceedings. 

        (i)    Debtor
shall promptly notify Secured Party if Debtor learns of any use by any person of any term or design which infringes on the Trademark or is likely to cause
confusion with the Trademark. If requested by Secured Party, Debtor, at Debtor's expense, shall join with Secured 

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Party
in such action as Secured Party, in Secured Party's discretion, may deem advisable for the protection of Secured Party's interest in and to the Trademark. 

        (j)    Debtor
shall maintain the validity of the NDA, shall file all reports required in connection with the NDA, and shall comply with the requirements in the NDA. 

        4.    EVENTS OF DEFAULT: ACCELERATION    

        All
Obligations shall become immediately due and payable upon demand, at the option of Secured Party, upon the occurrence of any breach of clause 4.1 (b) or 4.1
(c) of the Sale Agreement (each an "Event of Default" hereunder). 

        5.    RIGHTS AND REMEDIES    

        At
any time an Event of Default exists or has occurred and is continuing, in addition to all other rights and remedies of Secured Party, whether provided under this Agreement, applicable
law or otherwise, Secured Party shall have the following rights and remedies: 

        (a)   Secured
Party may require that neither Debtor nor any affiliate or subsidiary of Debtor make use of the Trademark or the NDA for any purpose whatsoever. Secured Party
may make use of the Trademark and the NDA for the manufacture and sale of goods, completion of work-in-process or rendering of services. 

        (b)   Secured
Party may grant such license or licenses relating to the Collateral for such term or terms, on such conditions, and in such manner, as Secured Party shall in its
discretion deem appropriate. Such license or licenses may be general, special or otherwise, and may be granted on an exclusive or non-exclusive basis throughout all or any part of the
United States. 

        (c)   Secured
Party may assign, sell or otherwise dispose of the Collateral or any part thereof, either with or without special conditions or stipulations except that if
notice to Debtor of intended disposition of Collateral is required by law, the giving often (10) days' prior written notice to Debtor of any proposed disposition shall be deemed reasonable
notice thereof and Debtor waives any other notice with respect thereto. Secured Party may buy the Collateral or any part thereof, and Secured Party may execute assurances and perform all other acts
which Secured Party may, in its discretion, deem appropriate or proper to complete such disposition. In any such event, Debtor shall be liable for any deficiency. 

        (d)   In
addition to the foregoing, in order to implement the disposition of any of the Col1ateral pursuant to the terms hereof, Secured Party may at any time execute and
deliver on behalf of Debtor, pursuant to the authority granted in the Power of Attorney described in Section 3(a) hereof, one or more instruments of assignment of the Trademark and the NDA (or
any application, registration, or recording relating thereto), in form suitable for filing, recording, or registration. Debtor agrees to pay Secured Party on demand all costs incurred in any such
transfer of the Collateral, including, but not limited to, any taxes, fees, and attorneys' fees and legal expenses. Debtor agrees that Secured Party has no obligation to preserve rights to the
Trademark or the NDA. 

        (e)   Secured
Party may first apply the proceeds actually received from any such license or disposition of any of the Collateral to the costs and expenses thereof, including,
without limitation, attorneys' fees and all legal, travel and other expenses which may be incurred by Secured Party. Thereafter, Secured Party may apply any remaining proceeds in accordance with the
Sale Agreement. Debtor shall remain liable to Secured Party for any of the Obligations remaining unpaid after the application of such proceeds, and Debtor shall pay Secured Party on demand any such
unpaid amount. 

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        (f)    Nothing
contained herein shall be construed as requiring Secured Party to take any such action at any time. All of Secured Party's rights and remedies, whether provided
under this Agreement, applicable law or otherwise, shall be cumulative and none is exclusive. Such rights and remedies may be enforced alternatively, successively or concurrently. 

        6.    TERMINATION OF SECURITY INTEREST    

        Upon
the satisfaction of the Obligations, the Secured Party shall immediately perform at its cost and expense the following acts to terminate the security interest granted hereunder: 

        (a)   Provide
written notice of the termination of the security interest to Debtor and return the original of this agreement to Debtor; 

        (b)   Return
the five (5) originals of the Special Power of Attorney to Debtor; 

        (c)   Provide
written notice of the termination of the inter-creditor agreement; 

        (d)   File
the appropriate documents with all state and federal agencies, including the PTO, terminating all previously filed agreements, documents and instruments evidencing
the security interest; and 

        (e)   Perform
all other reasonable acts requested by Debtor or the third party to the inter-creditor agreement in furtherance of this paragraph. 

        7.    GOVERNING LAW    

        The
validity, interpretation and enforcement of this Agreement shall be governed by the internal laws of the State of New Jersey but excluding any principles of conflicts of law. 

        8.    MISCELLANEOUS    

        (a)   All
notices, requests and demands hereunder shall be in writing and deemed to have been given or made: if delivered in person, immediately upon delivery; if by telex,
telegram or facsimile transmission, immediately upon sending and upon confirmation of receipt; if by nationally recognized overnight courier service with instructions to deliver the next business day,
one (1) business day after sending; and if by certified mail, return receipt requested, five (5) days after mailing. All notices, requests and demands upon the parties are to be given to
the following addresses (or to such other address as any party may designate by notice in accordance with this Section): 

	If to Debtor:	 	Amphastar Pharmaceuticals, Inc.

11570 Sixth Street

Rancho Cucamonga, CA 91730

Facsimile: 909-980-6139

Attention: Chief Financial Officer
	

If to the Secured Party:	
 	

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 J. Osinski, Vice President and General Counsel

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        (b)   All
references to the plural herein shall also mean the singular and to the singular shall also mean the plural. The words "hereof," "herein," "hereunder," "this
Agreement" and words of similar import when used in this Agreement shall refer to this Agreement as a whole and not any particular provision of this Agreement and as this Agreement now exists or may
hereafter be amended, modified, supplemented, extended, renewed, restated or replaced. 

        (c)   This
Agreement shall be binding upon Debtor and its successors and assigns, and shall inure to the benefit of and be enforceable by Secured Party and its successors and
assigns. 

        (d)   If
any provision of this Agreement is held to be invalid or unenforceable, such invalidity or unenforceability shall not invalidate this Agreement as a whole, but this
Agreement shall be construed as though it did not contain the particular provision held to be invalid or unenforceable and the rights and obligations of the parties shall be construed and enforced
only to such extent as shall be permitted by applicable law. 

        (e)   Neither
this Agreement nor any provision hereof shall be amended, modified, waived or discharged orally or by course of conduct, but only by a written agreement signed
by an authorized officer of Secured Party. A waiver by Secured Party of any right, power or remedy on anyone occasion shall not be construed as a bar to or waiver of any such right, power or remedy
which Secured Party would otherwise have on any future occasion, whether similar in kind or otherwise. 

        IN
WITNESS WHEREOF, Debtor and Secured Party have executed this Agreement as of the day and year first above written. 

	 	 	AMPHASTAR PHARMACEUTICALS, INC.
	

 	
 	

 	

 
	 	 	By:	/s/  DAVID W. NASSIF      

	 	 	Name:	David W. Nassif
	 	 	Title:	Chief Financial Officer and Senior Vice President of Global Licensing
	

 	
 	

 	

 
	 	 	ORGANON USA INC.
	

 	
 	

 	

 
	 	 	By:	/s/  PATRICK J. OSINSKI      

	 	 	 	Name: Patrick J. Osinski
	 	 	 	Title: Vice President
	

 	
 	

By:	

/s/  HUIB COSTERMANS      

	 	 	 	Name: Huib Costermans
	 	 	 	Title: Vice President

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	STATE OF NEW JERSEY	)	 
	 	)	ss.:
	COUNTY OF ESSEX	)	 

        On
this 26 day of June, 2003, before me personally came David W. Nassif, to me known, who being duly sworn, did depose and say, that he is the Chief Financial Officer and Senior Vice
President of Global Licensing of AMPHASTAR PHARMACEUTICALS, INC., the corporation described in and which executed the foregoing instrument; and that he signed his name thereto by order of the
Board of Directors of said corporation. 

	 	 	/s/  JOYCE A. VENEZIA      
 Joyce A. Venezia

Notary Public

	 	 	 	JOYCE A. VENEZIA Notary Public

State of New Jersey No. 2187917
	STATE OF NEW JERSEY	)	 	Qualified in Essex County
	 	)	ss.:	Commission Expires April 4, 2006
	COUNTY OF ESSEX	)	 	 

        On
this 26 day of June, 2003, before me personally came Patrick J. Osinski, to me known, who being duly sworn, did depose and say, that he is the Vice President of ORGANON
USA INC., the corporation described in and which executed the foregoing instrument; and that he signed his name thereto by order of the Board of Directors of said corporation. 

	 	 	/s/  JOYCE A. VENEZIA      
 Joyce A. Venezia

Notary Public

	 	 	 	JOYCE A. VENEZIA

Notary Public State of New Jersey
	STATE OF NEW JERSEY	)	 	No. 2187917
	 	)	ss.:	Qualified in Essex County
	COUNTY OF ESSEX	)	 	Commission Expires April 4, 2006

        On
this 26 day of June, 2003, before me personally came Huib Costermans, to me known, who being duly sworn, did depose and say, that he is the Vice President of ORGANON USA INC.,
the corporation described in and which executed the foregoing instrument; and that he signed his name thereto by order of the Board of Directors of said corporation. 

	JOYCE A. VENEZIA

Notary Public State of New Jersey

No. 2187917

Qualified in Essex County

Commission Expires April 4, 2006	 	/s/  JOYCE A. VENEZIA      
 Joyce A. Venezia

Notary Public

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ANNEX A

TO

SECURITY AGREEMENT  

 SPECIAL POWER OF ATTORNEY  

	STATE OF	 	)	 
	 	
	)	 
	 	 	)	ss.:
	COUNTY OF	 	)	 
	 	
	)	 

        KNOW
ALL MEN BY THESE PRESENTS, that AMPHAST AR PHARMACEUTICALS, INC., a California corporation ("Debtor"), hereby appoints and constitutes ORGANON USA INC., A New Jersey
corporation "Secured Party"), and each of its officers, its true and lawful attorney, with full power of substitution and with full power and authority to perform the following acts on behalf of
Debtor: 

        1.     Execution
and delivery of any and all agreements, documents, instrument of assignment or other papers which Secured Party, in its discretion, deems necessary or advisable
for the purpose of assigning, selling, or otherwise disposing of all right, title, and interest of Debtor in and to the Trademark and NDA (as defined in the Security Agreement referred to below) and
all registrations, recordings, reissues, extensions, and renewals thereof; or for the purpose of recording, registering and filing of, or accomplishing any other formality with respect to the
foregoing. 

        2.     Execution
and delivery of any and all documents, statements, certificates or other papers which Secured Party, in its discretion, deems necessary or advisable to further
the purposes described in paragraph 1 hereof. 

        This
Power of Attorney is made pursuant to a Security Agreement, dated of even date herewith, between Debtor and Secured Party (the "Security Agreement") and is subject to the terms and
provisions thereof. This Power of Attorney, being coupled with an interest, is irrevocable until all "Obligations", as such term is defined in the Security Agreement, are indefeasibly paid in full and
the Security Agreement is terminated in writing by Secured Party. 

Dated:
June    , 2003 

	 	 	AMPHASTAR PHARMACEUTICALS, INC.
	

 	
 	
By:	
 	

 
	 	 	 	 	

	 	 	 	 	Name:	 
	 	 	 	 	Title:	 

	 	 	)	 
	 	 	)	ss.:
	 	 	)	 
	    	 	 	 
	STATE OF	 	 	 
	 	
	 	 
	COUNTY OF	 	 	 
	 	
	 	 

        On
this    day of            , 2003, before me personally
came                        , to me known, who being duly sworn, did depose and say, that he is
the                        of
AMPHASTAR 

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PHARMACEUTICALS, INC.,
the corporation described in and which executed the foregoing instrument; and that he signed his name thereto by order of the Board of Directors of said corporation. 

	 	
 Notary Public

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Exhibit 10.6    
    

TOLL MANUFACTURING AGREEMENT  

        THIS AGREEMENT effective this 26 day of June, 2003 (hereinafter referred to as the "effective date") by and between Amphastar Pharmaceuticals, Inc., a
corporation organized under the law of the State of California, having its principal office at 11570 Sixth St., Rancho Cucamonga, CA 91730 (hereinafter "AMPHASTAR"), and ORGANON USA INC., a
corporation organized under that laws of New Jersey, having its principal office at 375 Mt. Pleasant Avenue, West Orange, New Jersey 07052 (hereinafter "ORGANON"). 

WITNESSETH: 

        WHEREAS,
AMPHASTAR will be commercially marketing the pharmaceutical compound Cortrosyn® for Injection (vials only) in the USA; 

        WHEREAS,
ORGANON has the necessary facilities, equipment, personnel, and professional experience to Gonvert bulk quantities of cosyntropin into finished vials of Cortrosyn®
for sale in the USA; and 

        WHEREAS,
AMPHASTAR is interested in retaining and ORGANON is interested in being retained by AMPHAST AR, as a manufacturer of vials of Cortrosyn® for sale in the USA. 

        NOW,
THEREFORE, ORGANON and AMPHASTAR agree as follows: 

ARTICLE 1—DEFINITIONS  

        1.1   "FDA"
means the United States Food and Drug Administration. 

        1.2   "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. 

        1.3   "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. 

        1.4   "Asset
Sale Agreement" means the Asset Sale Agreement dated the date of this Agreement between AMPHASTAR and ORGANON. 

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

        1.6   "Quality
Agreement" means the Quality Agreement dated the date of this Agreement between AMPHASTAR and ORGANON. 

        1.7   "Security
Agreement" means the Security Agreement dated the date of this Agreement between AMPHASTAR and ORGANON. 

ARTICLE 2—DESCRIPTION OF WORK  

        2.1   ORGANON
will manufacture for and supply to AMPHAST AR quantities of PRODUCT that conform in all respects to PRODUCT as specified in certain sections of the NDA attached
hereto as Exhibit A, the Quality Agreement and the master batch 2 record. AMPHASTAR agrees to obtain ORGANON'S written consent, which may not be unreasonably withheld or delayed, prior to the
submission to the FDA of any modifications to the NDA affecting the manufacture and/or packaging of 

1

 

the
PRODUCT. AMPHASTAR agrees to discuss any proposed modifications with ORGANON before seeking approval by FDA of a modification. Unless ordered by FDA, any such modification must be within ORGANON's
capability. If such modifications would affect the cost of producing finished PRODUCT and/or would require an investment in fixed assets, the financial consequences would be borne by AMPHASTAR.
AMPHASTAR acknowledges that its Product rights are limited to the United States. Pursuant to the NDA, AMPHASTAR agrees to sell PRODUCT only in the USA. 

        2.2   As
part of its services hereunder (and included in the Initial Price and Price defined in 3.1 hereunder,), AMPHASTAR wants ORGANON to supply, or to have supplied to it
all raw materials including API, glass vials, stoppers, vial labels, package inserts, carton labels and cartons necessary to manufacture PRODUCT in the quantities specified in this Agreement. 

        2.3   ORGANON
agrees to manufacture for and supply to AMPHAST AR, and AMPHASTAR agrees to purchase from ORGANON, "PRODUCT in batches of 70,000 vials, packaged in cartons of 10
labeled vials per carton with a package insert. At least sixty (60) days before each calendar year, AMPHASTAR will give ORGANON an annual forecast for PRODUCT to be manufactured in the
following calendar year. AMPHASTAR will give ORGANON a quarterly projection for PRODUCT to be manufactured during the upcoming quarter at least ninety (90) days before each calendar quarter.
Such projections shall include delivery dates. AMPHASTAR will provide ORGANON a firm purchase order no less than ninety (90) days prior to the delivery date of PRODUCT to AMPHASTAR. In the
event AMPHASTAR wishes to have more than one batch (70,000 units) of PRODUCT manufactured and supplied by ORGANON in any thirty (30) day period, AMPHAST AR shall give ORGANON a purchase order
for such PRODUCT at least ninety (90) days prior to the first delivery date in said purchase order. However, in no event shall ORGANON be obligated to manufacture, supply and deliver to
AMPHASTAR more than 2 batches (140,000 units) of PRODUCT, in any thirty (30) day period. 

        2.4   Notwithstanding
anything herein to the contrary, ORGANON retains all rights to manufacture, use and sell PRODUCT for sale outside the USA by its affiliates in those
countries where "Cortrosyn" product is currently approved. ORGANON may use "Cortrosyn" in connection with such sales. ORGANON agrees to use best efforts to ensure that no such sales by its foreign
affiliates involve re-sales into the United States. 

ARTICLE 3—PRICE AND PAYMENT  

        3.1   The
price to be paid by AMPHASTAR to ORGANON for quantities of PRODUCT manufactured by ORGANON and supplied to AMPHAST AR according to this Agreement will be $2.70 per
vial or $27.00 per carton of 10 vials (inclusive of all labels and package inserts) (hereinafter "Initial Price") during the first year of this Agreement. Thereafter, the Initial Price will be subject
to an upward adjustment on an annual basis of five percent (5%) during the term of this Agreement (the "Price"). 

        3.2   Stability Studies and Validation.

        ORGANON
shall perform stability studies on PRODUCT in accordance with ORGANON's commitments to the FDA, the cost of which shall be included in the Initial Price and the Price. ORGANON
will also perform validation studies of processes involving PRODUCT, consistent with the FDA's current Good Manufacturing Practices ("cGMPs"). AMPHASTAR will pay for PRODUCT made for these validation
studies at $2.70 per vial. 

        3.3   ORGANON
will issue invoices for the PRODUCT shipped F.O.B. ORGANON's plant, Allentown, Pennsylvania, to AMPHASTAR or pursuant to its instructions during the previous
month. 

        3.4   The
payment of each invoice is to be made to ORGANON by AMPHAST AR within thirty (30) days after the date of said invoice. It is agreed that ORGANON will not date
or mail any invoice 

2

 

to
AMPHAST AR prior to actual shipment of PRODUCT covered by said invoice. Further, ORGANON will not ship a lot to AMPHAST AR until the release procedures described in the Quality Agreement have been
met. Any amount not paid in such 30-day period shall thereafter bear interest at the rate of ten percent (10%) per annum. It is agreed that ORGANON will invoice AMPHAST AR for any
validation batches at the initiation of such work. 

        3.5   The
payment of each invoice is to be made to ORGANON by AMPHASTAR within thirty (30) days after the date of said invoice. Any amount not paid in such
30-day period shall thereafter bear interest at the rate of ten percent (10%) per annum. 

ARTICLE 4—QUALITY AND REGULATORY MATTERS  

        4.1   ORGANON
will maintain in-process quality control procedures in accordance with FDA cGMPs and will otherwise comply in all respects with the Quality
Agreement. 

        4.2   AMPHAST
AR shall have the right, but not the obligation, to inspect ORGANON's quality control procedures and records and to obtain specimens of PRODUCT from ORGANON's
production for analysis to confirm quality. Any AMPHASTAR employees who inspect ORGANON's facilities shall abide by all of ORGANON's policies, procedures and rules and shall enter into an appropriate
confidentiality agreement. AMPHAST AR shall assume all risk of loss and indemnify and hold ORGANON harmless from all liability and expenses (including legal fees and expenses) directly and proximately
resulting from their presence at ORGANON's facilities. Section 12.4 of the Asset Sale Agreement shall apply to such indemnification. 

        4.3   ORGANON
shall be responsible for all communications with any governmental entity relating to its manufacturing and packaging activities, including facility inspections,
and AMPHASTAR shall be responsible for all communications with any governmental entity concerning the marketing, sale and distribution of the PRODUCT in the United States. Notwithstanding the
foregoing, communications concerning the NDA shall be submitted by AMPHASTAR as owner of the NDA. 

        4.4   ORGANON
will, at its sole expense, comply with all laws applicable to production, packaging, testing, storage, shipment and recordkeeping by ORGANON of the PRODUCT and
its performance of its obligations hereunder, including all applicable laws or requirements under any applicable product registrations or manufacturing facility registrations. As long as ORGANON
manufactures PRODUCT for AMPHAST AR, it will pay any fees necessary to obtain and maintain manufacturing facility registrations and any other licenses, registrations, permits, exemptions, allowances,
authorizations, or approvals from a government entity which are applicable to its facilities used to manufacture and package the PRODUCT. 

ARTICLE 5—REPRESENTATIONS; INDEMNIFICATIONS; DAMAGES  

        5.1   ORGANON
represents that PRODUCT manufactured for and supplied to AMPHASTAR hereunder will comply in all respects with the specifications and product definition.
Additionally, the PRODUCT shall be free from defects in material, manufacturing and workmanship when delivered by ORGANON to the common carrier; provided that ORGANON makes no representation with
respect to any defects or nonconformity that cannot be readily tested or seen. 

        5.2   In
connection with this Agreement and transactions pursuant hereto, AMPHASTAR shall indemnify and hold ORGANON and its stockholders, directors, officers, employees,
representatives and agents harmless pursuant to Sections 12.3 and 12.4 of the Asset Sale Agreement. 

        5.3   In
connection with this Agreement and transactions pursuant hereto, ORGANON shall indemnify and hold AMPHASTAR and its stockholders, directors, officers, employees,
representatives and agents harmless pursuant to Sections 12.2 and 12.4 of the Asset Sale Agreement. 

3

 

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

        5.5   EXCEPT AS EXPRESSLY STATED HEREIN, ORGANON MAKES NO REPRESENTATIONS OR WARRANTIES. OF ANY KIND, EITHER EXPRESS OR IMPLIED, RELATED TO THE PRODUCT
INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

        5.6   Both
parties agree to maintain property, general liability and products liability insurance policies with minimum coverages of $5,000,000 per occurrence and in the
aggregate and to produce proof of such coverage immediately upon request of the other party. 

ARTICLE 6—TERM  

        6.1   This
Agreement shall commence on the.effective date and shall continue in effect for three (3) years from the effective date, unless terminated earlier pursuant
to Section 18.2 or at AMPHASTAR's election on six months' written notice to ORGANON. 

        6.2   Termination
of this Agreement shall not affect in any way whatsoever the parties' obligations set forth in Article 13 or Sections 5.2 and 5.3. 

        6.3   Upon
termination, AMPHAST AR, shall have the right to purchase all or some of the raw materials, glass vials, stoppers, vial labels, package inserts, carton labels and
cartons held pursuant to this Agreement, at cost. 

        6.4   In
advance of termination upon request of AMPHAST AR, ORGANON shall provide reasonable assistance to AMPHAST AR in the transfer of the manufacturing process for the
PRODUCT. 

ARTICLE 7—NOTICES  

        No notice, consent, acceptance, approval, waiver, or claim shall be valid or validly made or given unless in writing and hand-delivered or sent by
registered mail to the addresses of the parties as hereinafter set forth: 

	 	 	ORGANON USA INC.

375 Mt. Pleasant Avenue

West Orange, NJ 07052

Attention: Michael Novinski, President

with a copy addressed to Patrick J. Osinski,

Vice President and General Counsel
	

 	
 	

AMPHASTAR, PHARMACEUTICALS, INC.

11570 Sixth Street

Rancho Cucamonga, CA 91730

Attention: Chief Financial Officer

ARTICLE 8—WAIVER  

        Exercise by any party of any of its rights under this Agreement shall not be deemed to limit any other right or remedy that such party may have in law or equity.
The failure of either party at any time to require performance by the other party of any provision hereof shall in no way affect the full right to require such performance at any time thereafter; nor
shall the waiver by either party of a breach of 

4

 

any
provision hereof be taken or held to be a waiver of any prior or succeeding breach of such provision or as a waiver of the provision itself. 

ARTICLE 9—ASSIGNMENT OF AGREEMENT  

        Neither this Agreement nor any rights or obligations hereunder may be assigned by AMPHASTAR or ORGANON, either in whole or in part, without the prior written
consent of the other party which shall not be unreasonably withheld; provided, however, either party may make said assignment to an affiliate of that party, without releasing the assigning party of
any obligations under this Agreement. Further, either party may assign its rights and obligations to a successor (whether by merger, consolidation, reorganization or other similar event) or a
purchaser of all or substantially all of its assets without the consent of the other party or to a party who has a security interest in the Trademark or the NDA~ An attempt by either party to assign
the rights or obligations of this Agreement in violation of this Article shall give the other party the right to terminate this Agreement except for the provisions of Article 13 and
Sections 5.2 and 5.3 which shall remain in full force and effect, in addition to any other right, remedy, or claim which such party may have because of the other's failure to comply with this
Article. 

5

   ARTICLE 10—APPLICABLE LAW  

        The validity, interpretation, and performance of this Agreement, its Exhibit, and each of its provisions, shall be determined and governed by the laws of the
State of New Jersey. 

ARTICLE 11—SEVERABILITY  

        If any provision of this Agreement is found by a court of competent jurisdiction to be contrary to, or inconsistent with, any applicable law, regulation or
executive order, then the parties hereto shall negotiate in good faith in an attempt to agree upon a revised provision which departs from the original provision to the minimum extent necessary to
bring it into compliance with any such law, regulation or order. In the event that the parties cannot agree to a revised provision, the other provisions of this Agreement shall not be affected and
this Agreement shall remain in full force and effect and shall be construed in all respects as if such invalid provision were omitted. 

ARTICLE 12—FORCE MAJEURE  

        12.1 Neither
party shall be responsible or liable for failure to perform any part of this Agreement, or for any delay in the performance of any part of this Agreement,
directly or indirectly resulting from any foreign or dC1mestic embargoes, Acts of God, fires, floods, explosions, sabotage, riots, strikes or other labor disruptions, orders of governmental
authorities, shortages of labor, fuel, power or raw material, unavailability of equipment or supplies, unavailability or delays in transportation, or any other event (similar or dissimilar to the
foregoing) beyond the reasonable control of the party affected thereby. 

        In
the event that ORGANON is unable to meet the production commitments specified in this Agreement for a period greater than ninety (90) consecutive days ("Production Failure"),
then, ORGANON with the cooperation of AMPHASTAR will choose another company to make PRODUCT (which may be AMPHASTAR) and will release all production processes, procedures, information, and
other data to a company chosen by mutual agreement of the parties in order to allow that company to manufacture the PRODUCT subject to this Agreement (including adhering to the Initial Price or the
Price, as the case maybe). The company so chosen shall agree to be bound by the requirements of Article 13 as if such company were a party to this Agreement. In such case(s), ORGANON agrees to
furnish at least one (1) appropriately qualified employee, at ORGANON's cost and expense, as technical assistant, to be present during the manufacture of PRODUCT. The commitment contained in
this Section shall expire forty-five (45) days after ORGANON has again started producing the PRODUCT for AMPHAST AR under this Agreement. Also in the case of a. Production Failure,
AMPHASTAR'S liability to make any remaining payments to ORGANON under the Asset Sale Agreement shall be excused until re-supply of the PRODUCT has begun from the other company. ()f ORGANON
whichever comes first and a period of time has elapsed equal to the period of time in which no PRODUCT was being made. 

ARTICLE 13—CONFIDENTIALITY  

        13.1 Except
as provided in Section 13.3 and as required by law, all information made available under this Agreement on behalf of either party including, but not
limited to, all information contained in the Exhibit to this Agreement shall be kept confidential by the other party and shall not be disclosed by such other party other than to directors, officers,
employees, and its consultants who have a need to know such information and who have first agreed to maintain such information in confidence and not to use same (except as provided by this Agreement). 

        13.2 ORGANON
and AMPHASTAR shall take all such steps as are reasonably necessary to insure that their directors, officers, and employees, and those of their consultants, to
whom they disclose any 

6

 

confidential
information of the other party, will not disclose the same to any unauthorized person or use said information in any way except as provided by this Agreement. 

        13.3 The
provisions of this Article shall not apply to information which: 

        a)    was
already known by the receiving party at the time of its receipt, as evidenced by written records kept in the ordinary course of business; 

        b)    was
in the public domain at the time of its receipt, or entered the public domain thereafter through no fault of either party; 

        c)     is
subsequently obtained from a third person who is lawfully in possession of such information, and not in violation of any contractual, legal, or fiduciary obligation to
ORGANON or AMPHASTAR as the case may be; or 

        d)    is
independently (without knowledge of or reference to information about PRODUCT) developed by another as evidenced by written records kept in the ordinary course of
business. 

        13.4 The
provisions of this Article shall remain in force during the period of this Agreement and for all time after the termination thereof. Upon the termination of this
Agreement for any reason, each party shall either destroy or return to the other party all copies of any writings subject to this Article except that one copy may be retained for record purposes only
for reference in the event of a dispute concerning this Agreement or for compliance with governmental regulations. 

ARTICLE 14—TITLE TO GOODS  

        Title to and risk of loss of the finished PRODUCT, and all other items relating to the manufacture of PRODUCT, while in the possession of ORGANON is in ORGANON at
all times. AMPHASTAR shall obtain full coverage insurance covering its interest in such goods while in transit. 

ARTICLE 15—ENTIRE AGREEMENT  

        This Agreement including the Exhibit hereto and amendments thereto and AMPHASTAR's subsequent purchase orders and the Asset Sale Agreement, Quality Agreement, and
Security Agreement, to which ORGANON and AMPHASTAR are parties, dated the date of this Agreement, constitute the entire agreement between the parties with respect to the subject matter hereof and
supersede any and all prior oral or written agreements, commitments, or understandings with respect to the matters provided for herein. Except for Exhibit A hereto which may be amended or
modified according to Section 2.1 from time to time and AMPHASTAR's purchase orders, 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. 

ARTICLE 16—HEADINGS  

        Article headings used herein are not to be deemed or construed to be part of this Agreement, but are for convenience only and shall not limit or be deemed or
construed in any way to affect or limit the meaning of this Agreement. 

ARTICLE 17—FURTHER ASSURANCES  

        Each party hereto agrees to execute and deliver such further papers or agreements as may be necessary or desirable to effectuate the purpose of this Agreement and
carry out its provisions, including, but not limited to, papers or agreements that would facilitate AMPHASTAR's relationship with Diosynth or its affiliates in the manufacturing of the Active
Pharmaceutical Ingredient. 

7

 

ARTICLE 18—DEFAULT  

        18.1 Each
of the following shall constitute an Event of Default under this Agreement: 

        a)    The
failure of either party to perform its obligations under this Agreement, and the continuation of such failure after the non-defaulting party gives notice
to the defaulting party of such default and describes the default with reasonable particularity, if the defaulting party fails to cure such default within the "applicable cure period." The "applicable
cure period" will be as follows: 

        (A)  in
the case of non-payment of money, ten (10) days after the giving of such notice; and 

        (B)  for
all other defaults, thirty (30) days after the giving of such notice, except that if such other default is curable but the cure requires action by the
defaulting party, which, by its nature, cannot be
accomplished within such 30-day period, then the cure period shall be extended for such additional period—but only up to an additional ninety (90) days in any
event—as may be reasonably required to allow the defaulting party to fully accomplish the cure, but such extension shall only be made available if the defaulting party has started to take
appropriate action to accomplish such cure immediately after receiving notice of the default and if the defaulting party diligently continues taking such appropriate action until the cure is fully
accomplished. 

        b)    The
entry of an "Order for Relief' naming a party as a "Debtor" under Title 11 of the United States Code or upon the entry of a decree or order by a court having
competent jurisdiction in respect to any petition filed or action respecting a party directly involved in a reorganization, arrangement, creditors' composition, readjustment, liquidation, dissolution,
bankruptcy, or similar relief under any other present or future United States or other statute, law or regulation, whether or not resulting in the appointment of a receiver, liquidator, assignee,
trustee, custodian, sequestrator, or other similar official, and any such decree or order is in effect for a period of thirty (30) consecutive days. 

        c)     The
making by a party of an assignment for the benefit of creditors, or the admission by such party in writing of its inability to pay its debts generally as they become
due, or the taking of action by a party in furtherance of any such action. 

        d)    The
failure of AMPHASTAR to make any payment when due in the Asset Sale Agreement. 

        18.2 Upon
the occurrence of an Event of Default, the non-defaulting party shall have the right to terminate this Agreement upon notice to the defaulting party.
In addition, any default by either party under this Agreement shall entitle the non-defaulting party to all other remedies available at law or in equity. 

        18.3 Termination
of this Agreement pursuant to this Section will not relieve either party from any obligations in this Agreement which survive termination. 

ARTICLE 19—DISPUTE RESOLUTION  

        19.1 Any
dispute or claim arising out of or relating to this Agreement, including disputes or claims, arising out of or relating to the parties' decision to enter into this
Agreement, shall be settled by arbitration in accordance with the commercial arbitration rules of the American Arbitration Association, and judgment upon the award rendered in the arbitration
proceeding may be entered in any court of competent jurisdiction. Notwithstanding the preceding sentence, either party, solely for the purpose of seeking injunctive relief, may submit to any court of
competent jurisdiction, without first 

8

 

resorting
to arbitration, any claim arising out of the other party's failure to comply with any confidentiality obligations. 

        19.2 The
arbitration shall be conducted in Roseland, NJ by a panel of three arbitrators, one appointed by each party and the third appointed by the first two arbitrators. If
the first two arbitrators cannot agree on the third arbitrator, then each party shall nominate a proposed third arbitrator, and the third shall be selected from the two nominees by a coin flip. 

        19.3 The
arbitrators shall apply substantive legal principles equivalent to those applicable under the laws of New Jersey (without regard to its principles of conflicts of
laws), except that the interpretation and enforcement of this Article shall be governed by the Federal Arbitration Act. The parties shall seek to agree on the discovery and hearing procedures as well
as time limits such that the arbitrators shall issue their decision in the dispute no later than six months after the selection of the third arbitrator. Failing such agreement between the parties, the
arbitrators will provide for such procedures and will commit to resolution of the dispute within six months after selection of the third arbitrator. 

        19.4 The
arbitrators shall be bound by the express terms of this Agreement and may not amend or modify such terms. Any award rendered by the arbitrators shall be consistent
with the terms of this Agreement. 

        19.5 The
arbitrators may grant any remedy or relief that the arbitrators deem just and equitable, including injunctive relief and specific performance. The arbitrators shall
not award either party punitive damages, and the parties shall be deemed to have waived any right to such damages. The arbitrators shall issue written findings of fact and conclusions of law. 

        19.6 The
arbitration proceedings shall be confidential, and the arbitrators shall issue appropriate protective orders to safeguard both parties' confidential information. 

        19.7 Both
parties hereby irrevocably consent to the exercise of jurisdiction by the arbitral panel in Roseland, NJ. Both parties waive personal service of any summons,
complaint and other process, and agree that service may be made by registered mail to their addresses for notices set forth in this Agreement. 

9

 

        IN
WITNESS WHEREOF, the parties have hereto set their hands and seals: 

	

ORGANON USA INC.	
 	

AMPHASTAR PHARMACEUTICALS, INC.
	

By:	
 	

/s/  PATRICK J. OSINSKI      
	
 	

By:	
 	

/s/  DAVID W. NASSIF      

	

Name:	
 	

Patrick J. Osinski
	
 	

Name:	
 	

David W. Nassif

	

Title:	
 	

Vice President
	
 	

Title:	
 	

Chief Financial Officer and Senior Vice President of Global Licensing

	

By:	
 	

/s/  HUIB COSTERMANS      
	
 	

 	
 	

 
	

Name:	
 	

Huib Costermans
	
 	

 	
 	

 
	

Title:	
 	

Vice President
	
 	

 	
 	

 

10

 
TOLL MANUFACTURING AGREEMENT

EXHIBIT A  

 APPROVED SPECIFICATIONS*  

	—
	Supplement
S-002, Supplemental NDA for revised manufacturing procedure and updated manufacwring and controls section of the NDA 16-750

	—
	Supplement
S-013; Supplemental NDA for change in the specification of the UV absorbance ratio of the drug substance

	—
	Supplement
S-017, Supplemental NDA CBE-30 for a change in the in process specific gravity specification

	—
	Supplement
S-018, Supplemental NDA for labeling changes to market product without diluent
        

        

        

        

	*
	Part
of Regulatory Documentation File (see 1.1.18 of Asset Sale Agreement) to be delivered to Purchaser pursuant to Section 3.3 Deliverables. 

11

QuickLinks

Exhibit 10.6

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