Document:

QuickLinks
 -- Click here to rapidly navigate through this document

 
 

Exhibit 10.26    
    

SUPPLY AGREEMENT

  

dated as of December 16, 2004

  

between

  

WYETH,

   

acting through its Wyeth Consumer Healthcare Division

   

and

   

ARMSTRONG PHARMACEUTICALS, INC.

  

For Turnkey Manufacture and Supply of Primatene Mist  

          

  

  

    

Confidential
treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as
[***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

  

 
 

TABLE OF CONTENTS    
    

	1.	 	DEFINITIONS	 	1
	

2.	
 	

TECHNOLOGY TRANSFER FOR MANUFACTURE UNDER WYETH'S NDA	
 	

5
	

3.	
 	

EVALUATION AND CHOICE OF METHOD OF MANUFACTURE	
 	

7
	

4.	
 	

SUPPLY	
 	

9
	

5.	
 	

COMPLIANCE, QUALITY AND ENVIRONMENTAL	
 	

11
	

6.	
 	

MANUFACTURING CHANGES	
 	

14
	

7.	
 	

PRICE AND PAYMENT	
 	

15
	

8.	
 	

REPRESENTATIONS AND WARRANTIES	
 	

17
	

9.	
 	

INDEMNIFICATION AND INSURANCE	
 	

19
	

10.	
 	

TERM AND TERMINATION	
 	

21
	

11.	
 	

WYETH EQUIPMENT	
 	

22
	

12.	
 	

CONFIDENTIALITY	
 	

23
	

13.	
 	

FORCE MAJEURE	
 	

23
	

14.	
 	

INTELLECTUAL PROPERTY	
 	

24
	

15.	
 	

NOTICES	
 	

24
	

16.	
 	

GENERAL	
 	

25

i

        THIS SUPPLY AGREEMENT is made and entered into as of this 16th day of December 2004 (the "Effective Date"), between
WYETH, a corporation organized and existing under the laws of Delaware, acting through its Wyeth Consumer Healthcare Division, and having an address at Five Giralda Farms, Madison, New Jersey 07940
("WYETH") and ARMSTRONG PHARMACEUTICALS, INC., a corporation organized and existing under the laws of Delaware and having an address at 423 LaGrange Street, West Roxbury, Massachusetts 02132
("ARMSTRONG"). 

RECITALS  

        WHEREAS, ARMSTRONG is experienced in the manufacture of metered dose inhalers ("MDIs"); 

        WHEREAS, WYETH markets and sells MDIs containing epinephrine as the active ingredient and CFCs as the propellant under the brand name of
Primatene Mist®; 

        WHEREAS, WYETH desires to have ARMSTRONG provide turnkey production of WYETH's Primatene Mist® product, including primary and
secondary packaging and release of finished product to WYETH, and ARMSTRONG has agreed to provide such services on the terms and subject to the conditions set forth herein. 

        NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for good and valuable consideration the
receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows: 

1.     DEFINITIONS  

        1.1    Definitions.    

        As
used in this Agreement, the following capitalized terms have the meanings indicated below: 

        1.1.1 "Affiliate"
means, in the case of either Party, any corporation, joint venture, or other business entity, which directly or indirectly controls, is controlled by, or
is under common control with that Party. "Control," as used in Sections 1.1.1 and 10.6, means having the power to direct, or cause the direction of, the management and policies of an entity, whether
through ownership of voting securities, by contract or otherwise. Notwithstanding the foregoing, for purposes of this Agreement, the term "Affiliate" does not include entities in which a Party or its
Affiliates owns a majority of the ordinary voting power to elect a majority of the board of directors but is restricted from electing such majority by contract or otherwise, until such time as such
restrictions are no longer in effect. 

        1.1.2 "Approved
CFCs" means CFC 12 (dichlorodifluoromethane) and CFC 114 (dichlorotetrafluoromethane) that meet the specifications for such materials set forth in the
Specifications. 

        1.1.3 "ARMSTRONG"
has the meaning set forth in the Preamble. 

        1.1.4 "ARMSTRONG's
ANDA" means Abbreviated New Drug Application number 87-907 for the manufacture and sale of an MDI with epinephrine as the active ingredient
and CFCs as the propellant, as the same may be amended from time to time. 

        1.1.5 "ARMSTRONG's
Technical Information" means ARMSTRONG's ANDA and other Technical Information owned and controlled by ARMSTRONG and disclosed to or otherwise used by
WYETH hereunder. 

        1.1.6 "Batch"
means the mass or volume of Product obtained from a validated Manufacturing run. 

        1.1.7 "Certificate
of Analysis" means the document listing the results of the release tests conducted using approved Methods of Analysis for a specific Batch of Product in a
form agreed to 

 

by
the Parties in writing. The Certificate of Analysis will include, without limitation, Specifications, test method's identification, manufacturing date, re-test date and Product
Lot/Batch number. 

        1.1.8 "Confidential
Information" means all information, data, trade secrets and know-how, including without limitation about technical, business and financial
matters (including costs, profits, plans for future development, documentation, method of operation and marketing concepts) that is disclosed by or on behalf of a Party hereto to the other Party
hereto as a result of the working relationship between the Parties pursuant to this Agreement. For the avoidance of doubt, in the case of WYETH, its Confidential Information shall include WYETH's
Technical Information and WYETH's NDA and in the case of ARMSTRONG, its Confidential Information shall include ARMSTRONG's Technical Information and ARMSTRONG's ANDA. 

        1.1.9 "Contract
Year" means each consecutive twelve (12) month period during the Term, the first of which shall commence on the first day of the month following the
date of the shipment by ARMSTRONG to WYETH of the first commercial Batch of the Product and end on the first anniversary thereof. 

        1.1.10 "Effective
Date" has the meaning set forth in the Preamble. 

        1.1.11 "Facility"
means ARMSTRONG's facility located at 423 LaGrange Street, West Roxbury, Massachusetts 02132, and at 10 Dan Road, Canton, Massachusetts 02021, or any other
facility approved in writing by WYETH for the Manufacture of Product. 

        1.1.12 "FDA"
means the United States Food and Drug Administration or any successor entity thereto. 

        1.1.13 "FD&C
Act" means the Federal Food, Drug and Cosmetic Act, as the same may be amended or supplemented from time to time. 

        1.1.14 "Force
Majeure Event" has the meaning set forth in Article 13. 

        1.1.15 "Good
Laboratory Practices" or "GLPs" means the then current standards for non-clinical laboratories set forth in 21 CFR Part 58, as amended from
time to time. 

        1.1.16 "Good
Manufacturing Practice" or "GMP" means the then current standards for the manufacture of Active Pharmaceutical Ingredient ("API") as set forth in 21 CFR Parts
210 and 211, as amended from time to time; and any relevant good manufacturing practices set forth in the FD&C Act and applicable regulations promulgated thereunder. 

        1.1.17 "Improvements"
has the meaning set forth in Section 2.5. 

        1.1.18 "Indemnified
Party" has the meaning set forth in Section 9.1.3. 

        1.1.19 "Indemnifying
Party" has the meaning set forth in Section 9.1.3. 

        1.1.20 "Initial
Term" means the period beginning on the first day of the first Contract Year and ending at the end of the fourth Contract Year. 

        1.1.21 "Labor"
means the direct labor and benefit expense of ARMSTRONG's employees involved in the Manufacture of a unit of Product, determined in accordance with U.S.
generally accepted accounting principles consistently applied. 

        1.1.22 "Lot"
means a Batch identified with a unique identifying number and designated as such. 

        1.1.23 "Manufacture,"
"Manufactured" or "Manufacturing" means all activities involved in the production of the Product, including, without limitation, the purchase of
Materials, the preparation, formulation, filling, packaging (primary and secondary), component assembly, 

2

 

finishing,
testing, analysis, labeling, storage and release of the Product and the handling, storage and disposal of any residues or wastes generated thereby. 

        1.1.24 "Materials"
means all materials, including, without limitation, all raw materials, ingredients, components, packaging supplies and labels, required for the
Manufacture of Product. For purposes of clarity, Materials include Approved CFCs. 

        1.1.25 "Methods
of Analysis" means (a) if WYETH elects to proceed with Option A, the methods of analysis for the Product set forth in WYETH's NDA or (b) if
WYETH elects to proceed with Option B, the methods of analysis for the Product set forth in ARMSTRONG's ANDA and the additional Methods of Analysis set forth in Exhibit A attached hereto; in
either case as the same may be amended from time to time in accordance with Article 6. 

        1.1.26 "MDI"
means a metered dose inhaler. 

        1.1.27 "Option
A" means the Manufacture of the Product pursuant to WYETH's NDA. 

        1.1.28 "Option
B" means Manufacture of the Product pursuant to ARMSTRONG's ANDA. 

        1.1.29 "Overhead"
means the charges for direct overhead per unit of Product determined in accordance with U.S. generally accepted accounting principles consistently applied. 

        1.1.30 "Party"
or "Parties" means either WYETH, ARMSTRONG or both, as the context requires. 

        1.1.31 "Person"
means any natural person, corporation, general partnership, limited partnership, limited liability company, limited liability partnership proprietorship,
other business organization, trust, union, association or governmental authority. 

        1.1.32 "Product"
means an MDI containing epinephrine as the active ingredient and Approved CFCs as a propellant, which meets the Specifications. 

        1.1.33 "Recall"
means any action by any Party to recover title to or possession of Product sold or shipped to Third Parties or any action to prevent or interrupt the sale or
shipment by a Party of the Product to Third Parties that would have been subject to recall if it had been sold or shipped. 

        1.1.34 "Registration
Work" has the meaning set forth in Section 5.9. 

        1.1.35 "Regulatory
Approval" means all consents, permits, approvals, licenses, authorizations, qualifications, notices or orders that are issued or granted by Regulatory
Authorities which are required for the Manufacture, marketing, promotion, pricing and sale of the Product in the Territory. For the sake of clarity, Regulatory Approval includes ARMSTRONG's ANDA if
WYETH elects to proceed with Option B or WYETH's NDA if WYETH elects to proceed with Option A. 

        1.1.36 "Regulatory
Authority" or "Regulatory Authorities" means any domestic or foreign, federal, national, regional, state, county, city, municipal, local or other
administrative, legislative regulatory or other governmental authority, agency, department, bureau, commission, council or involved in the granting of Regulatory Approval for the Product in the
Territory. 

        1.1.37 "Regulatory
Requirements" means any and all legal and regulatory standards, procedures, protocols, guidelines or requests of any Regulatory Authority having
jurisdiction over the Product or the Manufacture thereof. 

        1.1.38 "Renewal
Term" means each one (1) year period commencing on the expiration of the Initial Term or the immediately preceding Renewal Term, until this Agreement
is terminated pursuant to Article 10. 

        1.1.39 "Rolling
Forecast" has the meaning set forth in Section 4.1(b). 

3

 

        1.1.40 "Seizure"
means any action by FDA or any other Regulatory Authority to detain or destroy the Product or prevent the release of the Product. 

        1.1.41 "Specifications"
means (a) if WYETH elects to proceed with Option A, the specifications set forth in WYETH's NDA, or (b) if WYETH elects to proceed with
Option B, the specifications set forth in ARMSTRONG's ANDA and the additional specifications set forth in Exhibit A attached hereto; in either case as the same may be amended from time to time
in accordance with Article 6. 

        1.1.42 "Technical
Information" means all information, data and know-how (whether or not patented or patentable) relating to the Manufacture of Product,
including, without limitation, all formulas, processes, specifications, test methods, methods of analysis, process validation procedures and the results thereof. 

        1.1.43 "Technology
Transfer Activities" means the work required to transfer the process and technology to Manufacture the Product under WYETH's NDA from WYETH's current
manufacturer to the Facilities, including, without limitation, the work specified in the Technology Transfer Plan. 

        1.1.44 "Technology
Transfer Plan" means the technology transfer plan to transfer the process and technology to Manufacture the Product under WYETH's NDA from WYETH's current
manufacturer to the Facilities, a copy of which is attached hereto as Exhibit C, as the same may be amended from time to time by notice in writing from WYETH to ARMSTRONG. 

        1.1.45 "Term"
means the Initial Term and all Renewal Terms, if any. 

        1.1.46 "Territory"
means the United States and its territories (including Puerto Rico) and possessions and the Caribbean. 

        1.1.47 "Third
Party" means any Person other than WYETH, ARMSTRONG and their respective Affiliates. 

        1.1.48 "Trademark"
means any trademark, tradename, tradedress, slogan, logo, copyright or similar item selected by WYETH for use in connection with the Product. 

        1.1.49 "WYETH"
has the meaning set forth in the Preamble. 

        1.1.50 "WYETH
Equipment" has the meaning set forth in Section 3.3(a). 

        1.1.51 "WYETH
Materials" means Approved CFCs delivered to ARMSTRONG for Manufacture of Products under Option A. 

        1.1.52 "WYETH's
NDA" means New Drug Application number 16-126 for the manufacture and sale of an MDI with epinephrine as the active ingredient and CFCs as the
propellant, as the same may be amended from time to time. 

        1.1.53 "WYETH
Requirements" mean any and all standards, procedures, protocols, guidelines or requests provided in writing to ARMSTRONG by WYETH regarding the quality,
regulatory compliance or otherwise for the Product that are different than or require a higher level of performance than the Regulatory Requirements. For the avoidance of doubt, WYETH Requirements
with respect to any particular activity hereunder shall only include those requirements provided in writing to ARMSTRONG prior to the date that such activity is completed. 

        1.1.54 "WYETH's
Technical Information" means WYETH's NDA and other Technical Information owned and controlled by WYETH and disclosed to or otherwise used by ARMSTRONG
hereunder. 

4

 

        1.2    Construction of Certain Terms and Phrases.    

        Unless
the context of this Agreement otherwise requires, (i) words of any gender include each other gender; (ii) words using the singular or plural number also include the
plural or singular number, respectively; (iii) the terms "hereof," "herein," "hereby" and derivative or similar words refer to this entire Agreement; (iv) the terms "Article" or
"Section" refer to the specified Article or Section of this Agreement; and (v) Article and Section headings shall not affect the meaning or construction of any provision of this Agreement. 

2.     TECHNOLOGY TRANSFER FOR MANUFACTURE UNDER WYETH'S NDA.  

        2.1    Technology Transfer.    

        Upon
the written request of WYETH, ARMSTRONG shall perform the Technology Transfer Activities specified in WYETH's request in accordance with the Technology Transfer Plan. The purchase
orders attached hereto as Exhibit D, which were issued to ARMSTRONG prior to the Effective Date, constitute a written request by WYETH to perform the Technology Transfer Activities set forth
therein. All other terms and conditions of such purchase orders are superseded by this Agreement. ARMSTRONG shall provide all resources necessary to perform the Technology Transfer Activities, except
when the Technology Transfer Plan specifically states that WYETH shall be responsible for providing materials or other resources. Consistent with the Technology Transfer Plan, each Party shall
designate a project manager who will be responsible for communicating all information concerning the Technology Transfer Activities to the other Party and shall have responsibility for providing
guidance and expertise with respect to the Technology Transfer Plan from WYETH to ARMSTRONG. 

        2.2    Termination of Technology Transfer Activities.    

        WYETH
may, at any time, by notice in writing to ARMSTRONG cancel the Technology Transfer Plan in whole or in part, or any individual Technology Transfer Activity. If WYETH delivers to
ARMSTRONG a notice that it has elected to proceed with Option B, then such notice shall be deemed to be a notice in writing from WYETH to ARMSTRONG terminating the Technology Transfer Plan in its
entirety. If upon receipt of notice of termination ARMSTRONG has not commenced the Technology Transfer Activities specified in such notice, then ARMSTRONG shall not do so. If ARMSTRONG has commenced
any of such Technology Transfer Activities, then ARMSTRONG shall terminate all activities with respect thereto and shall charge WYETH only for the work performed through the date of termination and
the documented reasonable costs associated with terminating such Technology Transfer Activity, not to exceed in the aggregate the fees specified in the Technology Transfer Plan for the performance of
the Technology Transfer Activity. 

        2.3    Payment for Technology Transfer Activities.    

        ARMSTRONG
shall invoice WYETH for Technology Transfer Activities requested by WYETH no more often per month than the number of requests ARMSTRONG receives per month from WYETH to
commence a specific Technology Transfer Activity. The costs of the Technology Transfer Activities shall be consistent with the costs set forth in Exhibit C, unless WYETH requests additional
work in writing to ARMSTRONG. For all Technology Transfer Activities ordered by WYETH on or after November 1, 2004, WYETH shall pay ARMSTRONG [***] of the estimated
costs of such Technology Transfer Activities within thirty (30) days of receipt of ARMSTRONG's invoice. ARMSTRONG shall not be obligated to commence any specific Technology Transfer Activity
before receiving such [***] of the estimated cost thereof. However, once ARMSTRONG has received such payment, it shall promptly 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

5

 

commence
a Technology Transfer Activity. WYETH shall pay any remaining amounts due for such work within thirty (30) days of satisfactory completion of the specific Technology Transfer
Activities by ARMSTRONG. Satisfactory completion in this context means that the Technology Transfer Activities have been completed consistently with the Technology Transfer Plan, Regulatory
Requirements and applicable WYETH Requirements. If WYETH determines that any Technology Transfer Activity does not meet the applicable requirements, it shall notify ARMSTRONG in writing of any
deficiencies and ARMSTRONG shall have thirty (30) days to correct such deficiencies. WYETH will pay
ARMSTRONG for only the portion of the Technology Transfer Activity that is satisfactory until any noted deficiencies are corrected, at which time WYETH shall pay any remaining costs of the work. 

        2.4    Quality and Compliance.    

        (a)   ARMSTRONG
shall comply with all current good clinical practices, Good Laboratory Practices and Good Manufacturing Practices in the conduct of the Technology Transfer
Activities. 

        (b)   ARMSTRONG
agrees to conduct all Technology Transfer Activities in a skillful, professional, safe and prudent manner, in accordance with the applicable WYETH
Requirements, applicable Regulatory Requirements and applicable laws (including without limitation the Federal Food Drug and Cosmetic Act or specific country requirements, as applicable) and in
compliance with all applicable provisions of this Agreement. ARMSTRONG shall maintain the necessary expertise, personnel and equipment to safely and lawfully perform the services described hereunder.
ARMSTRONG shall ensure the services performed are free from defects in performance and representatives who perform such services shall be properly trained and qualified to perform the tasks to which
they are assigned. To the extent that in performing any Technology Transfer Activity WYETH requests that ARMSTRONG meet standards that are higher than both (i) the standards that ARMSTRONG is
currently meeting and (ii) the standards required by applicable law, then ARMSTRONG shall provide WYETH with a timeline and a cost estimate for meeting such higher standards and, if WYETH
agrees to pay such costs, ARMSTRONG shall undertake the activities necessary to meet such higher standards in accordance with the agreed upon timeline. 

        2.5    Grant of License.    

        (a)   WYETH
hereby grants to ARMSTRONG a personal, limited, non-exclusive, non-transferable, non-assignable, royalty free license to use
WYETH's Technical Information solely for the purpose of Manufacturing the Product for WYETH pursuant to WYETH's NDA and for no other entity. Any improvements, adaptations or enhancements made to
WYETH's Technical Information ("Improvements") by ARMSTRONG will be deemed WYETH's Technical Information and the license granted to ARMSTRONG hereunder shall be deemed to include such Improvements.
ARMSTRONG shall execute all assignments and other documents as may be requested by WYETH to evidence and perfect WYETH's ownership of and/or right to use of the Improvements and the intellectual
property rights therein at WYETH's expense. The foregoing license shall terminate on the earlier to occur of WYETH's notice in writing to ARMSTRONG that it is terminating the Technology Transfer Plan
and the termination of this Agreement. Upon termination of the foregoing license, ARMSTRONG shall return all of WYETH's Technical Information to WYETH. 

        (b)   The
license granted in Section 2.5(a) shall not be construed (i) to effect any sale of WYETH Technical Information or (ii) except as expressly provided in
Section 2.5(a), to grant ARMSTRONG any rights in or to the use of the Technical Information by implication or otherwise. 

        (c)   If
WYETH elects to proceed with Option B, during the Term ARMSTRONG shall be deemed to grant WYETH personal, limited, non-transferable,
non-exclusive, non-assignable, 

6

 

royalty-free
license to use ARMSTRONG's Technical Information solely for the purpose of selling Product Manufactured under ARMSTRONG's ANDA. 

3.     EVALUATION AND CHOICE OF METHOD OF MANUFACTURE  

        3.1    Evaluation of Manufacture Under ARMSTRONG's ANDA.    

        (a)   ARMSTRONG
shall provide to WYETH, to the extent in its possession or otherwise reasonably available, all information requested or otherwise necessary for WYETH to
evaluate and assess ARMSTRONG's ANDA and ARMSTRONG's capabilities to Manufacture a Product under ARMSTRONG's ANDA that meets all Regulatory Requirements and WYETH Requirements. All information
requested by WYETH for purposes of evaluating ARMSTRONG's ANDA shall promptly be provided to WYETH. 

        (b)   As
of the Effective Date, ARMSTRONG has provided to WYETH samples of Product Manufactured pursuant to ARMSTRONG's ANDA so that WYETH may evaluate the quality,
composition, stability, components and other features of the Product from 2000 - 2002. ARMSTRONG has also provided summaries of the history of consumer complaints relating to
the Product. ARMSTRONG shall also provide to WYETH any and all procedures, protocols, testing or sampling of Product and quality assurance and quality control procedures and standards, and quality
control reports by which ARMSTRONG intends to Manufacture and release the Product pursuant to ARMSTRONG's ANDA. 

        3.2    Choice of Manufacture Method.    

        (a)   WYETH
shall have the right by notice in writing to ARMSTRONG to elect to proceed with Option A or Option B with respect to the Manufacture of Product hereunder. WYETH
shall notify ARMSTRONG, in writing, whether it elects to proceed with Option A or Option B. 

        (b)   Notice
to ARMSTRONG of WYETH's election to proceed with Option B shall serve as notice of termination of the Technology Transfer Plan in its entirety pursuant to
Section 2.2 above. 

        3.3    Pre-Manufacture Work by ARMSTRONG.    

        (a)    Option A Equipment and Corrective Measures.    If WYETH elects to proceed with Option A, then prior to
initiating validation or stability Batches for the Product, ARMSTRONG shall purchase, install and validate the equipment listed at Exhibit E and shall undertake all corrective measures
identified by WYETH including without limitation the corrective measures set forth in Exhibit E. Such work shall be completed consistently with all applicable Regulatory Requirements and WYETH
Requirements and in accordance with the timelines set forth by WYETH. WYETH shall pay the costs for such equipment consistently with the schedule and amounts set forth in Exhibit E. Any
equipment purchased by ARMSTRONG pursuant to this Section 3.3(a) shall be owned by WYETH (hereinafter referred to as "WYETH Equipment" or "Equipment"), and ARMSTRONG shall maintain such
Equipment consistent with the requirements of Section 11 below. 

        (b)    Option B Equipment and Pre-launch Activities.    

	(i)
	ARMSTRONG
shall purchase, install and validate the equipment and to undertake the corrective measures set forth in Exhibit E, and execute scale up and
pre-launch activities for work needed to upgrade and modify the Facilities to meet Regulatory Requirements for Manufacture of the Product under ARMSTRONG's ANDA and to prepare for
commercial production and release of the Product under ARMSTRONG's ANDA, which pre-launch activities include without limitation the activities set forth on Exhibit F. Such
scale-up, pre-launch activities, and any other work necessary to meet Regulatory Requirements for Manufacture and release of the Product, shall be undertaken 

7

 

consistently
with applicable Regulatory Approvals and Regulatory Requirements. All such work and equipment shall be paid for by ARMSTRONG. 

	(ii)
	If
WYETH elects to proceed with Option B, ARMSTRONG must complete pursuant to Subsection (b)(i) above. However, if WYETH elects to proceed with Option B after
[***] and if ARMSTRONG has commenced and substantially completed any of the activities set forth in subparagraph (b)(i) above and such work is not satisfactory to WYETH,
then WYETH may request in writing that ARMSTRONG undertake additional work to prepare for commercial production and release of the Product for WYETH. If WYETH requests that ARMSTRONG rerun stability
and validation batches or related testing, ARMSTRONG will perform such work and WYETH shall pay ARMSTRONG [***] for such work. If WYETH requests any additional testing or
processing, ARMSTRONG shall perform such work and WYETH shall pay ARMSTRONG at its usual and customary rate for professional services for such additional work, not to exceed
[***] per hour for such work.

	(iii)
	If
WYETH elects to proceed with Option B, ARMSTRONG shall amend ARMSTRONG's ANDA to provide for a [***]. ARMSTRONG shall purchase such
[***] manufactured from the Third Party manufacturer selected by WYETH. WYETH shall arrange for the design of such [***] and purchase and pay the mold
needed to manufacture the [***]. 

        (c)    Water System.    Regardless of whether Option A or Option B is chosen by WYETH for Manufacture of the Product,
ARMSTRONG shall purchase, install and validate a new water system suitable for the Manufacture of Product and meeting all Regulatory Requirements and WYETH Requirements and the criteria set forth in
Exhibit G. Such water system shall be purchased and installed at ARMSTRONG's cost and expense and at no cost to WYETH and shall be owned by ARMSTRONG. 

        3.4    Payment for Pre-Manufacture Work by ARMSTRONG.    

        (a)   WYETH
shall pay ARMSTRONG Five Hundred Thousand Dollars ($500,000) within fifteen (15) business days of the Effective Date(provided
that if the Effective Date is prior to December 17, 2004, then WYETH agrees to use reasonable efforts to pay such amount prior to December 31, 2004). This payment
shall be credited as follows: 

	(i)
	If
WYETH elects to proceed with Option B, then the entire amount shall be attributed to the total amount owed to ARMSTRONG by WYETH for Option B pursuant to
Section 3.4(b) below; or

	(ii)
	If
WYETH elects to proceed under Option A, then the entire amount shall be applied against any amounts otherwise owed by WYETH to ARMSTRONG under this Agreement for the
Technology Transfer Activities and premanufacture work pursuant to Section 3.3(a). 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

8

 

        (b)   If
WYETH elects to proceed with Option B, then WYETH agrees to pay ARMSTRONG a total of One Million Two Hundred Thousand Dollars ($1,200,000). In addition to the amounts
set forth in Section 3.4(a) above, payment for Option B shall be as follows: 

	(i)
	Five
Hundred Thousand Dollars ($500,000) (a) within fifteen (15) business days of WYETH's written notice to ARMSTRONG of its choice to proceed with Option
B, or (b) thirty (30) days after the Effective Date, whichever is later (provided that if WYETH elects to proceed with Option B prior to
December 23, 2004, then WYETH agrees to use reasonable efforts to pay such amount prior to December 31, 2004).

	(ii)
	Two
Hundred Thousand Dollars ($200,000) within thirty (30) days after receipt by WYETH of first commercial Batch of Product meeting all applicable Regulatory
Requirements and WYETH Requirements, Regulatory Approvals and the shelf-life standards set forth in Section 4.3. 

        (c)   Except
as set forth in this Section 3.4 and Section 3.3(b)(ii) and (iii), WYETH shall not be obligated to pay any additional amounts in respect of
Option B. Amounts paid pursuant to Sections 3.4 (a) and 3.4 (b) shall be non-refundable. 

4.     SUPPLY  

        4.1    Manufacture and Forecasts.    

        (a)   ARMSTRONG
shall Manufacture the Product consistently with the terms of this Agreement, applicable law, Regulatory Requirements and WYETH Requirements under the
applicable Regulatory Approvals. Except as set forth in Sections 4.1(b) and 4.4, WYETH shall order from ARMSTRONG its purchase requirements of Product during the Term. All orders by WYETH shall be in
whole multiples of full Batches. 

        (b)   Commencing
ninety (90) days before the first commercial Batch of Product is required by WYETH, WYETH shall submit to ARMSTRONG a forecast of Product that WYETH
anticipates ordering from ARMSTRONG during the following twelve (12) month period and WYETH shall update such forecast on a rolling twelve (12) month basis at the beginning of every
month thereafter (each a "Rolling Forecast") during the Term. WYETH shall place purchase orders for at least the quantity of Product specified in the first two (2) months of each such Rolling
Forecast and the remaining ten (10) months shall be a non-binding good faith estimate. Except as set forth in the immediately preceding sentence with respect to amounts specified in
the first two (2) months of a Rolling Forecast, WYETH shall not be required to order any fixed minimum quantity Product or any quantity of Product, notwithstanding any forecast or prior course
of dealing. ARMSTRONG acknowledges that WYETH has an agreement with another contract manufacturer (the "Other Contract Manufacturer"), pursuant to which WYETH is obligated to purchase Primatene Mist
product made by such other contract Manufacturer under WYETH's NDA. ARMSTRONG agrees that such purchases from such Other Contract Manufacturer shall not constitute a violation of this Agreement and
WYETH shall be relieved of its obligation to purchase its requirements of Product to the extent necessary to comply with such other agreement. 

        (c)   ARMSTRONG
shall Manufacture and deliver Product to WYETH in such quantities and at such times as ordered by WYETH pursuant to section 4.1(b) above. During the
Term, ARMSTRONG shall maintain the resources necessary to Manufacture Product and shall provide, at its own expense, all Materials and labor necessary to do so. 

9

  

        (d)   ARMSTRONG
shall deliver full Batches of the Product to WYETH under ARMSTRONG's ANDA and shall not share bulk or finished Product Batches supplied to WYETH with any Third
Party. 

        4.2    Orders and Delivery.    

        WYETH
shall place its firm orders for Product with ARMSTRONG by submitting a purchase order which sets forth (i) the quantity of Product ordered for delivery; and (ii) the
delivery date for that order. Any such order which is in accordance with the forecast set forth in Section 4.1(b) shall be deemed to be accepted by ARMSTRONG. For all other orders placed by
WYETH, unless ARMSTRONG notifies WYETH in writing within fifteen (15) days of receipt of a purchase order that it is unable to deliver Product in accordance with such purchase order, ARMSTRONG
shall be deemed to have accepted such purchase order as a binding order. If ARMSTRONG notifies WYETH that it is unable to fill such purchase order, it shall indicate the portion of such purchase order
ARMSTRONG cannot supply by the requested delivery date and specify alternate delivery dates. WYETH may cancel or modify any firm purchase order (in whole or in part) at any time prior to the delivery
for any quantity of Product that ARMSTRONG has not completed Manufacturing pursuant to such purchase order at the time that notice of cancellation is received by ARMSTRONG;  provided that if ARMSTRONG
has commenced but not completed the Manufacture of Product pursuant to such firm purchase order, WYETH shall reimburse
ARMSTRONG for [***] of the Material and Labor costs in respect of any works-in-progress pursuant to such cancelled or modified purchase order (or part
thereof) at the time notice of cancellation or modification is received by ARMSTRONG; and provided,  further, that WYETH shall reimburse ARMSTRONG for the cost of any other Material purchased by ARMSTRONG
to fill a cancelled or modified purchase order (or part thereof) that are unique to the Product and cannot within a reasonable period of time otherwise be used in ARMSTRONG's operations. All Product
shall be delivered F.O.B. ARMSTRONG's Facility in accordance with WYETH's instructions and title, possession and risk of loss shall pass to WYETH upon delivery of Product to WYETH's designated carrier
at ARMSTRONG's loading dock. In the event that the Product are not delivered F.O.B. ARMSTRONG's Facility on the date specified in the applicable purchase order, ARMSTRONG shall be responsible for any
reasonable costs incurred by WYETH as a result of such delay, including, without limitation, any additional costs charged by WYETH's designated carrier. 

        4.3    Shelf Life.    

        ARMSTRONG
shall schedule its Manufacturing operations so that all Product delivered has the maximum shelf life possible. No Product shall be shipped with a shelf-life less
than the greater of [***]. If ARMSTRONG delivers Product whose shelf life does
not conform to the requirements set forth in this Section 4.3, ARMSTRONG shall promptly, at its sole expense, replace the non-conforming Product. 

        4.4    Alternative Supply.    

        Notwithstanding
any provision herein to the contrary, WYETH may manufacture Products itself and/or qualify an alternative supplier of Products. WYETH shall be relieved of its obligation
to order its purchase requirements of Product from ARMSTRONG (i) with respect to any Product manufactured in connection with qualifying an alternative supplier; or (ii) if ARMSTRONG, for
any 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

10

 

reason,
is unable, anticipates that it will be unable or is unwilling to supply Product meeting WYETH's forecasted requirements for any period of time until such ability or willingness to supply
resumes; provided that WYETH shall continue to be relieved of its obligation to order its purchase requirements of Product from ARMSTRONG to the extent
necessary to fulfill any contractual commitment entered into during such period and to the extent that it has accumulated an inventory of Product during such period. 

5.     COMPLIANCE, QUALITY AND ENVIRONMENTAL  

        5.1    Compliance with Law.    

        ARMSTRONG
shall conduct its Manufacturing operations hereunder in a safe and prudent manner, in compliance with all applicable Regulatory Approvals, GMPs and all applicable laws and
regulations
(including, but not limited to, those dealing with occupational safety and health, those dealing with public safety and health, those dealing with protecting the environment, and those dealing with
disposal of wastes) in the Territory, and in compliance with all applicable provisions of this Agreement. ARMSTRONG shall obtain and maintain all necessary Regulatory Approvals for activities
contemplated by this Agreement and shall permit the inspection of its premises by Regulatory Authorities or WYETH and, at no additional cost to WYETH, shall supply all documentation and information
requested by WYETH to obtain or maintain Regulatory Approval of the Product. 

        5.2    Manufacturing Quality.    

        (a)   Except
for Approved CFCs supplied by WYETH for Manufacture under Option A, ARMSTRONG shall obtain all Materials from WYETH approved suppliers and shall pay such
suppliers on a timely and current basis. All Product shall be Manufactured by ARMSTRONG at the Facility using Materials and processing aids free of animal derived materials. ARMSTRONG shall meet all
applicable Regulatory Requirements and WYETH Requirements for the Manufacture of the Product, including but not limited to, the requirements set forth in the agreed upon Quality Agreement. On the
Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its
respective obligations under the Quality Agreement in accordance with such agreement. 

        (b)   ARMSTRONG
shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable Specifications therefor.
ARMSTRONG shall take all necessary steps to prevent contamination and cross contamination of Product. Product shall be unadulterated and free from contamination, diluents and foreign matter in any
amount. ARMSTRONG shall perform the quality control tests with respect to Product in accordance with the Specifications using the Methods of Analysis, the cost of the same to be included in the price
hereinafter specified. ARMSTRONG shall promptly, upon completion of such tests, deliver to WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of
Product. Upon request, ARMSTRONG shall deliver a representative sample from each Batch of Product to WYETH's designated representative by the date and in the manner specified by such representative.
ARMSTRONG shall pay the costs of shipping such samples to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, ARMSTRONG shall invoice WYETH for shipping
costs. 

        5.3    Purchase of Approved CFCs.    

        (a)   ARMSTRONG
shall use only Approved CFCs in the Manufacture of the Product, and shall maintain adequate volumes of such CFCs to Manufacture the number of units requested
by WYETH. ARMSTRONG shall obtain and maintain any necessary Regulatory Approvals for use and storage of Approved CFCs, including but not limited to maintaining all programs, procedures 

11

 

and
work required by Regulatory Authorities and/or necessary to comply with 40 CFR Part 82 and 21 CFR Part 2.125. Without limiting the generality of the foregoing, ARMSTRONG agrees to
undertake activities to comply with regulations to permit continuing Manufacture of Product with Approved CFCs, including maintaining the essential use exemption for epinephrine, according to 21 CFR
2.125 as described in Exhibit M attached hereto. To satisfy the specific requirement of Section 2(a) of Exhibit M, ARMSTRONG agrees to maintain a program to develop a
non-ozone depleting substance ("ODS") version of an over-the-counter epinephrine product, to either demonstrate substantial technical barriers to formulating
without ODSs exist, or that a non-ODS product can be developed. 

        (b)   If
WYETH elects to proceed with Option A, WYETH shall deliver to the Facility sufficient quantities of WYETH Materials necessary to Manufacture Products in accordance
with its firm purchase orders hereunder. ARMSTRONG shall receive, store and inventory WYETH Materials pending Manufacture of Products. ARMSTRONG shall furnish WYETH, in such form as WYETH shall
specify, with a monthly inventory and production report indicating quantities of WYETH Materials and Products on hand at the beginning of the month, received or produced during the month, used or
shipped during the month, and on hand at the end of each such month. Average allowable production loss of WYETH Materials shall be no greater than [***] per Batch. ARMSTRONG
shall be liable for any loss or damage to WYETH Materials delivered to it hereunder in excess of such average allowable production loss. 

        (c)   [***]
the [***], if [***] to have the
[***], and if [***] has [***] or [***] and [***] to
[***], then [***] to [***] at the [***] 

        (d)   Except
as set forth in Section 5.10, title to WYETH Materials shall remain in WYETH. ARMSTRONG shall not use any WYETH Materials furnished to it hereunder for any
purpose other than to Manufacture Products for WYETH hereunder. At all times, while WYETH Materials are in ARMSTRONG's possession or control, ARMSTRONG shall ensure that the WYETH Materials do not
become subject to any lien, charge, encumbrance or security interest. 

        5.4    Testing by WYETH.    

        WYETH
may test the Product samples in accordance with the Specifications using the Methods of Analysis. If the analysis of any Product performed by or for WYETH differs from ARMSTRONG's
analysis of the same Batch, WYETH shall advise ARMSTRONG within sixty (60) days of the analysis and ARMSTRONG and WYETH agree to consult with each other in order to explain and resolve the
discrepancy between each other's determination. If, after good faith attempt by the Parties to do so, such consultation does not resolve the discrepancy, an independent, reputable laboratory
designated by WYETH and reasonably acceptable to ARMSTRONG (such acceptance not to be unreasonably withheld or delayed) shall repeat the applicable Methods of Analysis on representative samples from
such Batch provided by or for WYETH. The costs of the independent laboratory referred to above shall be borne by (i) WYETH if such laboratory determines that the Product conforms to the
Specifications or (ii) ARMSTRONG if such laboratory 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

12

 

determines
that the Product does not conform to the Specifications. If so requested by WYETH in writing, ARMSTRONG shall promptly send a new Batch of Product (of similar quantity as to the amount of
such Product being analyzed as set forth above) to WYETH. WYETH shall not be obligated to pay for any Product that such laboratory determines that does not conform to the Specifications. ARMSTRONG, at
its election, may reimburse WYETH the costs of the failed Batch or may choose not to invoice WYETH for the replacement Batch. Regardless of the option chosen by ARMSTRONG, ARMSTRONG shall pay all
transportation costs for any replacement Batch. 

        5.5    Samples and Record Retention.    

        At
its expense, ARMSTRONG shall retain records and retention samples of each Batch of Product for at least twelve (12) months after the expiration date of that Batch and shall
make the same available to WYETH upon request. Retention samples shall only be destroyed after the required holding period and then only after sixty (60) days prior written notice to WYETH. If
WYETH requests in writing a longer retention period, then ARMSTRONG shall notify WYETH of the cost of retaining samples for such longer period. If WYETH agrees to reimburse ARMSTRONG for such costs,
ARMSTRONG shall retain such samples for such longer period. During and after the Term of this Agreement ARMSTRONG shall assist WYETH with respect to any complaint, issue or investigation relating to
Product. 

        5.6    Inspection.    

        WYETH
shall give ARMSTRONG at least seven (7) days advance written notice of an inspection by WYETH. In the case of an extraordinary circumstance (i.e., Recall, Seizure, Force
Majeure Event or other regulatory event), WYETH shall not be required to give ARMSTRONG such seven (7) days notice. ARMSTRONG shall give access
to representatives of WYETH, at all reasonable times during regular business hours, to the Facility and any other facility in which Product is Manufactured, tested and/or stored, and to all
Manufacturing records with respect to Product, for the purpose of inspection with respect to the Product. WYETH shall have the right while at any such Facility to inspect and copy ARMSTRONG's records
and Regulatory Approvals to evaluate work practices and compliance with all applicable FDA and other Regulatory Authority laws and regulations, occupational health and safety, and environmental laws
and regulations, GMP and warehousing practices and procedures with respect to the Product. Notwithstanding any inspection performed by WYETH, ARMSTRONG shall remain solely responsible for operating
its Facilities and for complying with its obligations under this Agreement. Neither the rights granted to WYETH pursuant to this Section 5.6, nor any inspection performance by WYETH, shall
impose any liability on WYETH. 

        5.7    Adverse Drug Experience Reporting.    

        If
WYETH elects to proceed with Option A, the Parties shall comply with the adverse drug experience reporting requirements set forth in Exhibit H attached hereto. If WYETH elects
to proceed with Option B, then the Parties shall comply with the adverse drug experience reporting requirements set forth in Exhibit I attached hereto. 

        5.8    Recalls and Seizure.    

        Each
Party shall keep the other Party promptly and fully informed of any notification or other information whether received directly or indirectly which might result in the Recall or
Seizure of the Product. If either Party determines that it is necessary to Recall the Product it shall immediately notify the other Party. Prior to commencing any Recall, the Parties shall review with
one another the manner in which the Recall is to be carried out and any instructions or suggestions of the applicable Regulatory Authorities. ARMSTRONG and WYETH shall effect the Recall in the manner
agreed upon between the Parties in as expeditious a manner as possible and in such a way as to cause the least disruption to the sales of the Product and to preserve the goodwill and reputation
associated with the Product. In any such situation, WYETH shall have the right to make all final decisions regarding such Recall if, in 

13

 

WYETH's
sole discretion, such situation has the potential to adversely affect or impact WYETH's ability to sell the Primatene Mist® product. 

        5.9    Support for Registration or Approval of Product outside of the Territory.    

        If
requested by WYETH in writing, ARMSTRONG shall provide stability Batches and validation Batches of the Product, engage in various development activities pre- and
post-approval inspections, perform various tests and assist WYETH in registration and approval activities for the Product outside of the Territory ("Registration Work"). For registration
of Product developed for a particular country or area outside of Territory, where such registration is undertaken at WYETH's request and solely to benefit WYETH, WYETH shall compensate ARMSTRONG for
such Registration Work at ARMSTRONG's customary charge for professional services, provided that such costs are approved by WYETH in writing prior to the initiation of the work. Any modifications or
changes to the Specifications required because of registration of the Product in additional countries within the Territory shall be incorporated into this Agreement by amendment as necessary. 

        5.10    Environmental, Occupational Health and Safety.    

        ARMSTRONG
shall report to WYETH as soon as possible after any of the following incidents related to the Manufacturing operations hereunder occurs: 

	(i)
	fatalities
and/or significant injuries or occupational illness;

	(ii)
	property
damage in excess of $50,000;

	(iii)
	inspections
by any environmental protection agency or occupational health and safety agency; or

	(iv)
	requests
for information, notices of violations or other significant governmental and safety agency communications relating to environmental, occupational health and
safety compliance. 

        As
of the Effective Date, for hazardous waste generated by the Manufacturing operations, ARMSTRONG shall only use those waste haulers, brokers and disposal sites for which it has
notified WYETH in writing and WYETH has accepted. If ARMSTRONG desires to change such waste
haulers, brokers or disposal sites after the Effective Date, it shall notify WYETH in writing thirty (30) days before it changes any waste haulers, brokers or disposal sites which were in place
at the time of the Effective Date. During the thirty (30) day notice period, WYETH shall have the opportunity to object, and shall notify ARMSTRONG in writing of its objection. ARMSTRONG shall
have thirty (30) days to select a new waste hauler, broker or disposal site of which WYETH approves. If the Parties cannot agree on an alternate, WYETH shall have the right to terminate this
Agreement upon ninety (90) days written notice to ARMSTRONG. ARMSTRONG shall have title to and be responsible for disposing in an environmentally safe manner all residue and waste resulting
from the Manufacturing operations performed hereunder. ARMSTRONG shall not use WYETH trademarks or trade dress to identify any waste materials or residues. 

6.     MANUFACTURING CHANGES  

        6.1    Voluntary Changes.    

        ARMSTRONG
shall not make any changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis,
components or source of the components, without requesting such change in writing and obtaining the prior written consent of WYETH. If WYETH requests in writing a change in the Manufacturing process,
the Manufacturing equipment, the Specifications, the Materials, the source of Materials or the Methods of Analysis with respect to the Product that is not a result of a requirement of FDA or any 

14

 

other
Regulatory Authority, ARMSTRONG shall use all reasonable efforts to make or accept such change. The requesting Party shall provide the other Party with a detailed written report of all proposed
changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis, components or source of components, as
applicable. In the event that any changes proposed by WYETH result in an increase in the cost of production of Product by ARMSTRONG, ARMSTRONG shall notify WYETH of any adjustment to its charges and
WYETH shall determine, in its sole discretion, whether to accept such increase or to withdraw the proposed change. In the event that any changes proposed by WYETH result in a decrease in the cost of
production of Product by ARMSTRONG, ARMSTRONG shall adjust its charges to WYETH accordingly and WYETH shall pay the decreased price. All changes proposed by ARMSTRONG shall be paid for by ARMSTRONG. 

        6.2    Required Changes.    

        If
FDA or any other Regulatory Authority requests or requires, or takes any action that requires, any change in the Manufacturing process, the Manufacturing equipment, the
Specifications, the Materials, the source of Materials or Methods of Analysis, the components or the source of the components with respect to the Product, the Parties shall meet and discuss an
implementation plan for such change and use all commercially reasonable efforts to accommodate such change to meet the FDA's or such other Regulatory Authority's requirements. Each Party will bear its
respective costs associated with, or incurred as a result of, such change. Each Party agrees to promptly forward to the other copies of any written communication received by such Party from the FDA or
any other Regulatory Authority that may affect the Manufacture or supply of the Product as contemplated herein. 

7.     PRICE AND PAYMENT  

        7.1    Price.    

        (a)   Price per unit for Manufacture under WYETH's NDA.    If WYETH elects to proceed with Option A, ARMSTRONG shall
invoice WYETH for Product at the prices set forth in Exhibit J attached hereto for Product delivered to WYETH hereunder. The price per unit set forth in Exhibit J for Product
Manufactured under Option A specifically excludes the costs of Approved CFCs, which will be paid for by WYETH. The prices set forth in Exhibit J shall not be increased by ARMSTRONG except
pursuant to the price adjustment formulas set forth below in Sections 7.2 and 7.3. The price for Product includes all of the costs of Manufacture of the Product and delivery FOB to WYETH's carrier at
the Facility. 

        (b)   Price per unit for Manufacture under ARMSTRONG's ANDA.    If WYETH elects to proceed with Option B, ARMSTRONG
shall invoice WYETH for Product delivered to WYETH hereunder at the prices set forth in Exhibit K attached hereto. The price per unit set forth in Exhibit K for Product Manufactured
under Option B specifically includes the costs of Approved CFCs which will be paid for by ARMSTRONG. The prices set forth in Exhibit K shall not be increased by ARMSTRONG except pursuant to the
price adjustment formulas set forth below in Sections 7.2 and 7.3. The price for Product includes all of the costs of Manufacture of the Product and delivery FOB to WYETH's carrier at the Facility. 

        7.2    Materials Cost Price Adjustments.    

        Commencing
with the start of the second Contract Year, ARMSTRONG may propose an adjustment to the prices to reflect documented changes in the acquisition cost of Materials to ARMSTRONG
per unit of Product at the beginning of the Contract Year in question as compared to the acquisition cost of such Materials per unit of Product at the beginning of the immediately preceding Contract
Year (the Material cost to be used for purposes of this comparison for the first price adjustment pursuant to this Section 7.2 shall be those set forth in Exhibits J and K hereto); 

15

 

 provided that, ARMSTRONG gives WYETH not less than ninety (90) days' prior written notice of any proposed price increase and that ARMSTRONG may not increase the price
more than once during any Contract Year; and provided, further,  that any proposed price increase per unit of
Product shall not exceed [***] above the acquisition cost of Materials at the
beginning of the immediately preceding Contract Year, except that if the acquisition cost of Materials increase by more than [***] above the acquisition cost of Materials at
the beginning of the immediately preceding Contract Year, then the Parties shall meet and negotiate in good faith a price adjustment to account for such Material costs above such
[***]. If WYETH does not accept ARMSTRONG's proposed price increases, the Parties shall negotiate in good faith. If the Parties conclude their negotiations and agree upon
Product prices, such agreed upon price increases shall be effective as of the expiration of such ninety (90) day notice period. In the event that the Parties are unable to agree during the
negotiations described above, the Agreement may be terminated effective six (6) months after the expiration of such ninety (90) day notice period upon written notice of one Party to the
other. Until the date of such termination, ARMSTRONG shall supply WYETH such Products at the prices then in effect without such price increase. ARMSTRONG agrees to use all reasonable efforts to keep
Material costs as low as possible and that WYETH can make such suggestions to ARMSTRONG to lower the cost of Materials, which ARMSTRONG agrees to take into account. ARMSTRONG further agrees to
actively work with WYETH to select vendors who provide quality Materials at competitive prices. 

        7.3    Labor and Overhead Cost Adjustments.    

        (a)   At
the start of the second Contract Year, the fourth Contract Year and each Contract Year thereafter, ARMSTRONG may propose an adjustment to the prices to reflect
documented changes in the costs of Labor and Overhead, respectively, per unit of Product at the beginning of the Contract Year in question as compared to the acquisition cost of such Labor or Overhead
per unit of Product at the beginning of the immediately preceding Contract Year (the Labor and Overhead costs to be used for purposes of this comparison for the first price adjustment are those set
forth in Exhibits J and K attached hereto); provided that, ARMSTRONG gives WYETH not less than ninety (90) days' prior written notice of any
proposed price increase and that ARMSTRONG may not increase the price more than once during any Contract Year; and provided,  further, thatany proposed price increase per unit of Product shall not exceed
[***] above the respective Labor or Overhead costs at the beginning of the previous Contract Year. If WYETH does not accept ARMSTRONG's proposed price increases, the Parties
shall negotiate in good faith. If the Parties conclude their negotiations and agree upon Product prices, such agreed upon price increases shall be effective as of the expiration of such ninety
(90) day notice period. In the event that the Parties are unable to agree during the negotiations described above, the Agreement may be terminated effective six (6) months after the
expiration of such ninety (90) day notice period upon written notice of one Party to the other.
Until the date of such termination, ARMSTRONG shall supply WYETH such Products at the prices then in effect without such price increase. 

        (b)   Any
downward changes to cost of Materials, Labor or Overhead shall also accrue to the benefit of WYETH in the calculations set forth above and the unit price will be
modified accordingly. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

16

   
        7.4    Continuous Improvement Price Adjustment.    

        Continuous
improvement initiatives, mutually agreeable to the Parties shall be established to provide for continuous cost reductions during the Term hereof. Continuous improvement teams
consisting of equal representation from each Party shall use reasonable efforts to work to identify and implement cost savings. Any documented savings shall be allocated to the Parties in proportion
to the level of contribution by each Party to realize the savings. Any cost savings allocated to WYETH shall be in the form of reduced purchase price. 

        7.5    Most Favored Nations Price Adjustment.    

        Notwithstanding
any provision herein to the contrary, if ARMSTRONG has made or makes sales of the Product to any Person at a price lower
than the price then in effect hereunder for such Product, such lower price shall be made available to WYETH hereunder, with respect to WYETH's inventory of Product as well as future purchases of
Product, for so long as ARMSTRONG continues to make sales to such Person at such lower price (provided that if WYETH is still purchasing Primatene Mist
product from the Other Contract Manufacturer after January 1, 2006, then ARMSTRONG shall have the right to suspend the most favored nations pricing provisions of this Section 7.5 until
such time as WYETH notifies ARMSTRONG in writing that it is no longer purchasing Primatene Mist product from the Other Contract Manufacturer). 

        7.6    Payment.    

        Except
for invoices for Technology Transfer Activities which will be paid pursuant to Section 2.3 above, WYETH shall pay invoices for Product delivered hereunder not later than
thirty (30) days after the later of receipt of Product covered by such invoice and receipt of such invoice; provided that WYETH shall not be
required to pay any invoice which is in dispute. 

        7.7    Taxes and Other Charges.    

        All
Product prices are inclusive of taxes. 

        7.8    Audit Rights.    

        WYETH
shall have the right, at its own expense, to access the books and records of ARMSTRONG and its Affiliates as may be reasonably necessary to verify the accuracy of any proposed
increases for Overhead, Material costs and/or Labor costs referred to in Section 7.2 and 7.3 and of the pricing referred to in Section 7.5. Such access shall be conducted after thirty
(30) days' prior written notice to ARMSTRONG and during ordinary business hours and shall not be more frequent than once per Contract Year or in respect of any Contract Year ending not more
than thirty-six (36) months prior to the date of such notice. If WYETH's report shows any overpayment by WYETH, ARMSTRONG shall remit to WYETH within thirty (30) days after
WYETH's receipt of such report, (i) the amount of such overpayment, (ii) interest on such overpayment at the prime rate from the date payment was first due until the date of payment of
such overpayment, and (iii) if such overpayment exceeds five percent (5%) of the total amount owed for the period then being audited, the reasonable fees and expenses of any independent
accountant performing the audit on behalf of WYETH.

8.     REPRESENTATIONS AND WARRANTIES  

        8.1    Representation and Warranties of Each Party.    

        Each
of WYETH and ARMSTRONG hereby represents, warrants and covenants to the other Party hereto as follows: 

        8.1.1
it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of incorporation or formation; 

17

 

        8.1.2
the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and do not require any shareholder action or
approval; 

        8.1.3
it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder; 

        8.1.4
the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a
breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument
binding or affecting it or its property; (ii) the provisions of its charter or operative documents or by laws; or (iii) any order, writ, injunction or decree of any court or governmental
authority entered against it or by which any of its property is bound; and 

        8.1.5
it shall comply with all applicable laws and regulations relating to its activities under this Agreement. 

        8.2    Representations and Warranties of ARMSTRONG.    

        8.2.1
ARMSTRONG hereby represents, warrants and covenants to WYETH with respect to each delivery of Product that: 

        8.2.1.1
the Product (i) has been Manufactured, stored and shipped in strict accordance with GMPs, all applicable laws, rules, regulations or requirements and all applicable
Regulatory Approvals in effect at the time of Manufacture; (ii) conforms to the Specifications and the Quality Agreement, and is free from defects and is merchantable; and (iii) is not
adulterated or misbranded. 

        8.2.1.3
ARMSTRONG has good and marketable title to the Product and the Product is free from all liens, charges, encumbrances and security interests; 

        8.2.1.4
the Manufacture of the Product does not infringe any intellectual property rights of any Third Party (except to the extent that ARMSTRONG is using WYETH's Technical Information
in the Manufacture of the Product to which ARMSTRONG does not make any representation or warranty); 

        8.2.1.5
ARMSTRONG did not use in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USC §335a(k)(l) and further it did not use
any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Product or any service rendered to WYETH; and 

        8.2.1.6
ARMSTRONG shall at its option either (i) promptly replace, at its sole cost and expense, any Product that fails to comply with the requirements of this
Section 8.2.1 or (ii) promptly reimburse
WYETH for the amount paid in respect of Product that fails to comply with the requirements of this Section 8.2.1. 

        8.2.2
ARMSTRONG hereby further represents, warrants and covenants to WYETH that: 

        8.2.2.1
ARMSTRONG is the owner of ANDA # 87-907 and such ANDA approved by FDA for the manufacture and release of the Product for commercial use; 

        8.2.2.2
ARMSTRONG has completed all corrective actions identified by WYETH during its due diligence, compliance audits and environmental audits to WYETH's satisfaction; 

        8.2.2.3
ARMSTRONG possesses all necessary Regulatory Approvals in the Territory with respect to the Manufacture of the Product hereunder; 

18

 

        8.2.2.4
ARMSTRONG has secured and shall maintain a supply of Approved CFCs adequate for Manufacture of the Product consistently with the terms of this Agreement, and it has all
Regulatory Approvals, equipment and facilities necessary for storage and use of such Approved CFCs consistently with such Regulatory Approvals, applicable law and the terms of this Agreement; and 

        8.2.2.5
as of the Effective Date, ARMSTRONG has never attempted to obtain any Regulatory approvals from any Regulatory Authority outside of the Territory. 

        8.3    Representation and Warranties by WYETH    

        WYETH
herby represents, warrants and covenants to ARMSTRONG that: 

        8.3.1
WYETH is the owner of NDA # 16-126 and such NDA is approved by FDA for the Manufacture and release of the Product for commercial use; and 

        8.3.2
the use of the WYETH Technical Information in the Manufacture of the Product does not infringe any intellectual property rights of any Third Party. 

        8.4    Representation by Legal Counsel.    

        Each
Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In
interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions. 

9.     INDEMNIFICATION AND INSURANCE  

        9.1   Indemnification.

        9.1.1
ARMSTRONG shall defend, indemnify and hold harmless WYETH, its Affiliates, directors, officers, employees and agents from and against all damages, losses, liabilities, expenses,
claims, demands, suits, penalties or judgments or administrative or judicial orders (including reasonable attorneys' fees and expenses) incurred, assessed or sustained by or against WYETH, its
Affiliates, directors, officers, employees or agents with respect to or arising out of (i) the negligent acts or omissions of ARMSTRONG; (ii) any breach by ARMSTRONG of this Agreement or
its representations, warranties or covenants hereunder; (iii) any Recall or Seizure attributable to ARMSTRONG's performance (including without limitation amounts WYETH may pay or credit to its
customers for Product so Recalled or Seized); (iv) the Manufacture of the Product by ARMSTRONG; (v) any allegation that the Manufacture, importation, sale, offer for sale or use of any
Product infringes any patent or other proprietary or protected right, except to the extent that any such allegation relates to the WYETH's Technical Information; (vi) any enforcement or other
action by any Regulatory Authority relating to the Manufacture of the Product, the pricing of the Product by ARMSTRONG to WYETH or sale of the Product by ARMSTRONG to WYETH; (vii) the use of
the WYETH Equipment; or (viii) ARMSTRONG's failure to comply with any applicable law, regulation or order (including environmental laws, regulations and orders). The provisions of this Section
shall survive the termination or expiration of this Agreement. 

        9.1.2
WYETH shall defend, indemnify and hold harmless ARMSTRONG, its Affiliates, directors, officers, employees and agents from and against all damages, losses, liabilities, expenses,
claims, demands, suits, penalties or judgments or administrative or judicial orders (including reasonable attorneys' fees and expenses) incurred, assessed or sustained by or against ARMSTRONG, its
Affiliates, directors, officers, employees or agents with respect to or arising out of (i) the negligent acts or omissions of WYETH; (ii) any breach by WYETH of its representations,
warranties or covenants hereunder; (iii) solely with respect to Manufacture of the Product under WYETH's NDA, any allegation that the WYETH's Technical Information infringes 

19

 

any
patent or other proprietary or protected right of any Third Party; or (iv) any breach by WYETH of this Agreement resulting in an enforcement or other action by any Regulatory Authority. The
provisions of this Section shall survive the termination or expiration of this Agreement. 

        9.1.3
Each Party and its Affiliates, directors, officers, employees or agents (an "Indemnified Party") shall promptly notify the other Party (the "Indemnifying Party"), in writing, of
any claim asserted or threatened against such Indemnified Party for which such Indemnified Party is entitled to indemnification hereunder from the Indemnifying Party. With respect to any such claim
the Indemnified Party shall, at no out-of-pocket expense to it, reasonably cooperate with and provide such reasonable assistance to such Indemnifying Party as such Indemnifying
Party may reasonably request. Such reasonable assistance may include, without limitation, providing copies of all relevant correspondence and other materials that the Indemnifying Party may reasonably
request. The obligations of an Indemnifying Party under Sections 9.1.1 and 9.1.2 are conditioned upon the delivery of written notice to the Indemnifying Party of any asserted or threatened claim
promptly after the Indemnified Party becomes aware of such claim; provided that the failure of the Indemnified Party to give such notice or any delay
thereof shall not affect the Indemnified Party's right to indemnification hereunder, except to the extent that such failure or delay impairs the Indemnifying Party's ability to defend or contest any
such claim. The Indemnifying Party shall have the right to assume the defense of any suit or claim for which indemnification is sought with counsel reasonably acceptable to the Indemnified Party. If
the Indemnifying Party defends the suit or claim, the Indemnified Party may participate in the defense thereof at its sole cost and expense. An Indemnifying Party may not settle a suit or claim
without the consent of the Indemnified Party if (i) such settlement would impose any monetary obligation on the Indemnified Party for which indemnification is not provided hereunder,
(ii) or require the Indemnified Party to submit to an injunction or otherwise limit the Indemnified Party's rights under this Agreement, or (iii) does not include a release of the
Indemnified Party from all liability arising out of such suit or claim. Any payment made by an Indemnifying Party to settle any such suit or claim shall be at its own cost and expense. 

        9.2    Insurance.    

        ARMSTRONG
shall maintain the following kinds of insurance with the minimum limits set forth below. 

	Kind of Insurance
	 	Minimum Limits

	Commercial General Liability, including Contractual, Completed Operations and Product Liability	 	$2,000,000 Per Occurrence $5,000,000 Aggregate
	

Workers Compensation	
 	

Statutory with Employer's Liability of not less than $1,000,000 Per Accident/Disease
	

Automobile Bodily Injury Liability (including hired automobile and non-ownership Liability)	
 	

$1,000,000 Each Accident Combined Single Limit

        Upon
request, ARMSTRONG shall furnish insurance certificates as directed by WYETH, satisfactory in form and substance to WYETH, showing the above coverages, and providing for at least
thirty (30) days' prior written notice to WYETH by the insurance company of cancellation or modification. WYETH shall be named as an additional insured on the ARMSTRONG's policies. Coverage
shall be procured with carriers having an A.M. Best rating of A-VII or better. 

20

 

10.   TERM AND TERMINATION  

        10.1   Term.

        This
Agreement shall commence on the Effective Date and continue, unless sooner terminated as set forth below in this Article 10, or in Article 13 for the duration of the
Initial Term. After the Initial Term, this Agreement shall continue for successive Renewal Terms unless either (a) WYETH shall have given written notice of termination to ARMSTRONG not less
than six (6) months prior to the expiration of the Initial Term or the then current Renewal Term, or (b) ARMSTRONG shall have given written
notice of termination to WYETH not less than twenty-four (24) months prior to the expiration of the Initial Term or the then current Renewal Term. 

        10.2   Termination Without Cause.

        WYETH
may terminate this Agreement by giving six (6) months written notice to ARMSTRONG (a) at any time prior to commencement of the first Contract Year; or (b) at
any time if WYETH, in its sole discretion, determines to cease marketing the Product. Such termination shall not give rise to the payment of any penalty, damages or indemnity by WYETH. 

        10.3   Termination for Regulatory Action or Claim of
Infringement.

        WYETH
may terminate this Agreement immediately upon written notice to ARMSTRONG, if (a) the FDA or any other Regulatory Authority takes any action, or makes a public statement or
other determination, the result of which is to prohibit, inhibit or restrict the Manufacture, storage, importation, sale, offer for sale or use of the Product either generally or specifically by
ARMSTRONG, or (b) any claim is made that the Manufacture, storage, importation, sale, offer for sale or use of the Product, infringes any patent or other proprietary or protected right of any
Third Party. Such termination shall not give rise to the payment of any penalty, damages or indemnity by WYETH. 

        10.4   Termination for Breach.

        If
either Party shall at any time fail to discharge any of its obligations hereunder and shall fail to correct such default within thirty (30) days after the other Party shall
have given written notice to it thereof, the aggrieved Party shall be entitled to notify the other Party that it intends to terminate this Agreement unless such default is corrected and may so
terminate ten (10) days after the end of such thirty (30) day period if such default is continuing; provided that if such default by the
other Party shall be a recurring default and the other Party does not reasonably satisfy the Aggrieved Party that such defaults shall cease to occur the Aggrieved Party shall be entitled to terminate
this agreement upon the occurrence of such default and the other Party shall not be entitled to correct such default. Such termination shall not give rise to the payment of any penalty, damages or
indemnity by the terminating Party. 

        10.5   Termination for Bankruptcy.

        If
either Party by voluntary or involuntary action goes into liquidation, dissolves or files a petition for bankruptcy or suspension of payments, is adjudicated bankrupt, has a receiver
or trustee appointed for its property or estate, becomes insolvent or makes an assignment for the benefit of creditors, the other Party shall be entitled by notice in writing to such Party to
terminate this Agreement forthwith. Such termination shall not give rise to the payment of any penalty, damages or indemnity by the terminating Party. 

21

 

        10.6   Termination Upon Change in Control.

        If
a significant part of ARMSTRONG's assets or the voting shares of ARMSTRONG shall, directly or indirectly, become vested in or subject to the direction and Control of a Person other
than the Persons in which it is vested on the Effective Date, or it becomes reasonably foreseeable that such changes shall occur ARMSTRONG shall so notify WYETH, and in such event, WYETH may terminate
this Agreement by giving ARMSTRONG written notice within sixty (60) days of WYETH's receipt of ARMSTRONG's notice. Such termination shall not give rise to the payment of any penalty, damages or
indemnity by WYETH. 

        10.7   Effect of Termination.

        Termination
or expiration of this Agreement, in whole or in part, shall be without prejudice to the right of either Party to receive all payments accrued and unpaid at the effective date
of such termination or expiration, without prejudice to the remedy of either Party in respect to any previous breach of any of the representations, warranties or covenants herein contained and without
prejudice to any other provisions hereof which expressly or necessarily call for performance after such termination or expiration. 

        10.8   WYETH's Rights on Termination.

        Upon
termination or expiration of this Agreement for any reason, (i) at WYETH's request, ARMSTRONG shall supply WYETH with its inventory of Materials, Product and/or
works-in-progress for the Manufacture, packaging and labeling of Product and WYETH shall pay ARMSTRONG, a prorated portion of the price for such Product for work in progress
commenced against firm orders by WYETH and the cost of Materials unless ARMSTRONG elects to sell such Product or materials to a Third Party; (ii) at WYETH's request all WYETH's Technical
Information shall be returned to WYETH; (iii) at WYETH's request, ARMSTRONG shall return to WYETH all retention samples of Product Manufactured pursuant to WYETH's NDA. For Product Manufactured
pursuant to ARMSTRONG's ANDA, ARMSTRONG shall grant WYETH access to such retention samples, without charge, for the period of time the samples are retained by ARMSTRONG; and (iv) all WYETH
Materials shall be returned to WYETH. 

        10.9   Survival.

        The
following provisions shall survive the expiration or termination of this Agreement: Sections 5.5, 5.7, 5.8, 5.10, 7.8, 9.1, 10.8 and Articles 8, 11, 12 and 14. 

11.   WYETH EQUIPMENT  

        11.1   Ownership and Use.

        If
WYETH elects to proceed with Option A and ARMSTRONG purchases the WYETH Equipment pursuant to Section 3.3(a) above, during the Term, ARMSTRONG shall have the right to possess
and use the Equipment in accordance with, and subject to, this Article 11. The Equipment shall be owned by WYETH and ARMSTRONG shall sign and deliver to WYETH any document that WYETH
requests to evidence WYETH's ownership of the Equipment and place a placard indicating that it is the property of WYETH. 

        11.2   Installation and Maintenance.

        ARMSTRONG,
at its cost and expense, shall install the Equipment in the Facility and shall provide all auxiliary equipment and other items necessary to operate such Equipment. ARMSTRONG
shall not remove the Equipment from the Facility without WYETH's prior written consent. 

22

 

ARMSTRONG,
at its expense, shall keep the Equipment in good repair and free from all liens, charges, encumbrances and security interests, and shall furnish all maintenance, parts and repairs for the
Equipment. ARMSTRONG shall maintain the Equipment in good and proper working order, and in compliance with applicable GMPs. ARMSTRONG understands and agrees that WYETH makes no representation or
warranty of any kind, express or implied, whether of merchantability or fitness or against infringement or otherwise, with respect to the Equipment. 

        11.3   Risk of Loss.

        ARMSTRONG
shall bear the entire risk of loss, theft, damage or destruction of the Equipment from any cause whatsoever. In the event that the Equipment is stolen, damaged or destroyed
from any cause whatsoever, ARMSTRONG shall be responsible for paying WYETH an amount equal to the replacement value thereof. 

        11.4   Return. 

        Upon
the expiration or termination of this Agreement, ARMSTRONG shall deliver the Equipment to WYETH in accordance with WYETH's instructions and at WYETH's expense. If ARMSTRONG does not
comply within ten (10) days after receipt of such instruction, then upon five (5) business days written notice to ARMSTRONG, WYETH shall have the right to enter the Facility during
business hours (or
any other site where the Equipment is then located) and remove the Equipment without any payment or liability to ARMSTRONG whatsoever. 

12.   CONFIDENTIALITY  

        12.1   Confidentiality. 

        The
parties shall use and disclose Confidential Information consistently with the terms of that certain Non-Disclosure Agreement, dated December 10, 2003, and attached
hereto as Exhibit L. 

        12.2   Publicity. 

        All
publicity, press releases and other announcements relating to this Agreement or the transactions contemplated hereby shall be reviewed in advance by, and shall be subject to the
approval of, both Parties. 

13.   FORCE MAJEURE  

        If
the production, delivery, acceptance or use of Product specified for delivery under this Agreement or if the performance of any other obligation hereunder is prevented, restricted or
interfered with by reason of fires, accidents, explosions, earthquakes, floods, breakdown of plant, embargoes, government ordinances or requirements, civil or military authorities, acts of God or of
the public enemy, or other similar causes beyond the reasonable control of the Party whose performance is affected (any of the foregoing a "Force Majeure Event"), then the Party affected, upon giving
prompt written notice to the other Party, shall be excused from such performance on a day-for-day basis to the extent of such prevention, restriction, or interference (and the
other Party shall likewise be excused from performance of its obligations on a day-for-day basis to the extent such Party's obligations relate to the performance so prevented,
restricted or interfered with); provided that the Party so affected shall use all commercially reasonable efforts to avoid or remove such causes of
non-performance and both Parties shall proceed to perform their obligations with dispatch whenever such causes are removed or cease. If such Force Majeure Event continues for a period of
ninety (90) consecutive days or more and as a result either Party has been unable to perform its obligations under this Agreement for such ninety (90) day period, the other Party may
terminate this Agreement effective immediately, upon delivery of a notice of termination in writing, provided that such event of Force Majeure Event is
continuing. If as 

23

 

a
result of any Force Majeure Event above, ARMSTRONG is unable to fully supply WYETH's orders hereunder, ARMSTRONG shall allocate all available quantities of Materials and Product to WYETH in the
ratio that the quantities ordered by WYETH in the twelve (12) month period immediately preceding such Force Majeure Event bears to ARMSTRONG's requirements for its own use and for supply to
Third Parties for that same period; provided that if this Agreement has not been in effect for a full twelve (12) month period, then such shorter
period shall be used in lieu of a twelve (12) month period. 

14.   INTELLECTUAL PROPERTY  

        14.1   Trademarks.

        WYETH
may advertise, promote, market and sell the Product under any of its Trademarks, whether registered or unregistered, in its sole discretion. ARMSTRONG shall have no right, title or
interest in or to any such Trademark. So long as WYETH or any Affiliate of WYETH shall have any interest in any such Trademark, whether registered or unregistered, whether as proprietor, owner, or
licensee in any country of the world, ARMSTRONG shall not adopt, use, apply for registration, register or own such Trademark, or any such mark confusingly similar thereto in any country of the world,
or take any action which, in WYETH's sole opinion, weakens or undermines WYETH's proprietary rights. 

        14.2   Technical Information.

        All
WYETH Technical Information is the sole and exclusive property of WYETH. Nothing herein, either express or implied, shall be deemed to grant ARMSTRONG any rights or license in or to
the WYETH Technical Information, except to the extent necessary to perform its obligations hereunder. 

15.   NOTICES  

        15.1   Ordinary Notices.

        Correspondence,
reports, documentation, and any other communication in writing between the Parties in the course of ordinary implementation of this Agreement shall be delivered by hand,
sent by facsimile or by overnight courier to the employee or representative of the other Party who is designated by such other Party to receive such written communication at the address or facsimile
numbers specified by such employee or representative. 

        15.2   Extraordinary Notices.

        Extraordinary
notices and communications (including without limitation, notices of termination, Force Majeure Event, material breach, change of address, requests for disclosure of
Confidential Information, claims or indemnification) shall be in writing and shall be delivered by hand, sent by facsimile or by overnight courier (and shall be deemed to have been properly served to
the addressee upon receipt of such written communication) to the address set forth in Section 15.3 or such other address as notified in writing by such Party to the other Party. 

24

 

        15.3   Addresses.

        If
to WYETH: 

Wyeth
Consumer Healthcare, a division of Wyeth

Five Giralda Farms

Madison, New Jersey 07940

Attention: Associate Director of Contract Manufacturing

Facsimile No.: 973-660-7325 

        With
a copy to: 

Wyeth

Five Giralda Farms

Madison, New Jersey 07940

Attention: General Counsel

Facsimile No.: 973-660-7050 

If
to ARMSTRONG: 

Armstrong
Pharmaceuticals, Inc.

c/o Amphastar Pharmaceuticals, Inc.

11570 Sixth Street

Rancho Cucamonga, California 91730

Attention: Chief Financial Officer

Facsimile No.: 909-980-6139 

16.   GENERAL  

        16.1   Governing Law.

        This
Agreement shall be construed in accordance with and governed by the law of the State of New York, without giving effect to its conflict of laws provisions. 

        16.2   Equal Opportunity Clause.

        The
Equal Opportunity Clause required by Executive Orders 11246, as amended (41-CFR 60-1.4) and 11375, the Employment Assistance to Veterans Clause required by
Executive Order 11701 (41 CFR 60-250.4), the Vietnam Era Veteran Readjustment Act of 1972, the Employment of the Handicapped Clause required by the Rehabilitation Act of 1973 (41 CFR
60-741.4) and the Americans with Disabilities Act of 1991 are part of this Agreement and binding upon ARMSTRONG unless exempted by rules, regulations or orders of the Secretary of Labor.
ARMSTRONG agrees that the applicable clause with regard to the utilization of minority contractors set forth at 41 CFR 1-1.303 and the applicable clause with regard to the Utilization of
Small Business Concerns and Small Business Concerns Owned and Controlled by Socially and Economically Disadvantaged Individuals set forth at 41 CFR 1-1.13 are incorporated herein by
reference, as applicable. ARMSTRONG agrees to provide information and documentation with respect to the foregoing to WYETH upon request. 

        16.3   Assignment.

        This
Agreement shall not be assignable or transferable by either Party hereto without the prior written consent of the other Party, except that one Party may assign this Agreement
without the other Party's consent to the successor or the transferee of all, or substantially all, of the Product, assets or business to which this Agreement relates or to one of its Affiliates.
ARMSTRONG shall not subcontract any of its work hereunder without WYETH's prior written consent and any such consent 

25

 

given
by WYETH shall not release ARMSTRONG from its obligations hereunder. Any attempted assignment in violation of this Section 16.3 shall be null and void, without any force or effect. 

        16.4   Entire Agreement.

        This
Agreement and all Exhibits attached hereto (as the same may be amended from time to time by the written agreement of the Parties) constitute the entire agreement between the Parties
with respect to the subject matter hereof and supersedes all other documents, agreements, verbal consents, arrangements and understandings between the Parties with respect to the subject matter
hereof. This Agreement shall not be amended orally, but only by an agreement in writing, signed by both Parties that states that it is an amendment to this Agreement. 

        16.5   Severability.

        If
any term of this Agreement shall be found to be invalid, illegal or unenforceable, it is the intention of the parties that the remainder of this Agreement shall not be affected
thereby; provided that neither Party's rights under this Agreement are materially adversely affected. It is further the intention of the parties that in
lieu of each such provision which is invalid, illegal or unenforceable, there be substituted or added as part of this Agreement a provision which shall be as similar as possible in the economic and
business objectives intended by the Parties to such invalid, illegal or unenforceable provision, but which shall be valid, legal and enforceable. In the event that either Party's rights are materially
adversely affected as a result of a change in this Agreement as contemplated by this Section, such Party may terminate this Agreement by notice in writing to the other Party given no later than sixty
(60) days after such change. 

        16.6   Independent Contractor.

        ARMSTRONG
shall act as an independent contractor and neither Party shall have any authority to represent or bind the other Party in any way. 

        16.7   No Waiver.

        Any
waiver by one Party of any right of such Party or obligation of the other Party must be in writing and shall not operate as a waiver of any subsequent right or obligation. 

        16.8   Counterparts.

        This
Agreement may be executed in two or more counterparts (including by facsimile transmission), each of which when so executed and delivered shall be an original, but all of which
together shall constitute one and the same instrument. 

26

 

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

	 	 	WYETH, acting through its

Wyeth Consumer Healthcare Division
	

 	
 	

By:	
 	

/s/  LARRY G. SANDERS      
 Name: Larry G. Sanders

Title: Senior Vice President, Global Finance
	

 	
 	
ARMSTRONG PHARMACEUTICALS, INC.
	

 	
 	

By:	
 	

/s/  DAVID NASSIF      
 Name: David Nassif

Title: Chief Financial Officer

27

   EXHIBIT A  

Additional Product Specifications and Methods of Analysis

(Qualified Armstrong or USP Method)  

 [***]  

[***] Certain information comprising 2 pages has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions. 

28

   EXHIBIT B  

Form of Quality Agreement  

CONTRACT MANUFACTURING  

 QUALITY AGREEMENT  

by and between 

	Supplier Name:	 	Armstrong Pharmaceuticals Inc
	Address:	 	423 LaGrange Street, West Roxbury, MA 02132
	
("Supplier")
	

and
	Sponsor Name:	 	Wyeth, acting by and through its Wyeth Consumer Healthcare
	Address:	 	5 Giralda Farms, Madison, NJ 07940
	
("Wyeth")
	

for
	
Epinephrine MDI with CFC as propellant
	
("Product")

29

   Contents  

	 	 	Approval Page
	1.	 	Effective Date
	2.	 	Scope
	3.	 	Other Agreements
	4.	 	Amendments to Quality Agreement
	5.	 	Term of Quality Agreement
	6.	 	Use of Third Parties
	7.	 	Survival Clause
	8.	 	Assignment
	9.	 	Resolution of Quality Issues
	10.	 	Debarment
	11.	 	Choice of Law: Jurisdiction/Miscellaneous
	12.	 	Quality Responsibilities Table

	 	 	A.	 	Compliance Requirements
	 	 	B.	 	Right to Audit
	 	 	C.	 	Regulatory Inspections and Exchanges
	 	 	D.	 	Regulatory Documentation
	 	 	E.	 	Animal Derived Materials
	 	 	F.	 	Buildings and Facilities
	 	 	G.	 	Personnel and Training
	 	 	H.	 	Sub-Contracting and Testing
	 	 	I.	 	Change Control
	 	 	J.	 	Validation/Qualification
	 	 	K.	 	Preventative Maintenance and Calibration
	 	 	L.	 	Investigations
	 	 	M.	 	Documentation and Records
	 	 	N.	 	Annual Product Reviews
	 	 	O.	 	Annual Product Report (if applicable)
	 	 	P.	 	Production and In-Process Controls, Packaging and Labeling
	 	 	Q.	 	Process Equipment
	 	 	R.	 	Reprocess
	 	 	S.	 	Rework
	 	 	T.	 	Laboratory Controls
	 	 	U.	 	Retest
	 	 	V.	 	Stability (if applicable to service being provided)
	 	 	W.	 	Storage and Distribution
	 	 	X.	 	Control, Disposal and Destruction of Production Materials
	 	 	Y.	 	Complaints
	 	 	Z.	 	Field Alerts, Biological Product Deviation Reports and Recalls

 Appendices:  

        Appendix 1:    (Definition of Product)  

        Appendix 2:    (Contacts and Responsibilities)  

30

   Contract Manufacturing  

 Quality Agreement  

by and between 

	Supplier Name:	 	Armstrong Pharmaceuticals Inc
	Address:	 	423 LaGrange Street, West Roxbury, MA 02132
	
("Supplier")
	

and
	Sponsor Name:	 	Wyeth, acting by and through its Wyeth Consumer Healthcare Pharmaceuticals Division
	Address:	 	5 Giralda Farms, Madison, NJ 07940
	
("Wyeth")

for

Epinephrine MDI with CFC as propellant  

Supplier and Wyeth wish to define the individual responsibilities of the parties as to the quality aspects of manufacturing and release of Product to ensure compliance with the
approved Product application and/or Wyeth requirements. 

In
order to do so, this Contract Manufacturing Quality Agreement ("Quality Agreement") takes the form, in part, of a detailed listing of activities associated with pharmaceutical manufacture, supply,
production, analysis, and release of Product. Unless otherwise indicated, Responsibility for each activity is assigned to either Wyeth, Supplier, or is assigned to both Supplier and Wyeth. 

IN CONSIDERATION of the parties' agreement to perform the activities provided in this Quality Agreement and for other valuable consideration the receipt
and sufficiency of which is hereby acknowledged, and intending to be legally bound, Supplier and Wyeth agree as provided in this Quality Agreement as follows: 

	WYETH Consumer Healthcare	 	Armstrong Pharmaceuticals, Inc.
	

 Signature	
 	

 Signature
	

 Name	
 	

 Name
	

 Title	
 	

 Title
	
Signed the            day of            in the year 2004.	
 	

Signed the            day of            in the year 2004.
	 	 	 

31

 

	

WYETH Consumer Healthcare	
 	

Armstrong Pharmaceuticals, Inc.
	

 Signature	
 	

 Signature
	

 Name	
 	

 Name
	

 Title	
 	

 Title
	
Signed the            day of            in the year 2004.	
 	

Signed the            day of            in the year 2004.

32

   1.     Effective Date  

The
Effective Date of this Quality Agreement shall be the date of last signature (the "Effective Date"). 

The
Effective Date for this Quality Agreement is the    day of the month of                        in the year
20    . 

2.     Scope  

This
Quality Agreement outlines the responsibilities of Supplier and Wyeth with respect to the quality assurance of the Product manufactured and/or supplied by Supplier for Wyeth, as defined in  Appendix 1 (Definition of Product)(the "Product"). 

3.     Other Agreements  

This
Quality Agreement is in addition to all other agreements between the parties, if any, (the "Primary Agreement") regarding the subject matter hereof. If there are any direct conflicts between the
terms of this Quality Agreement and the Primary Agreement, the provisions in the Primary Agreement shall govern and control. 

4.     Amendments to Quality Agreement  

This
Quality Agreement may be amended by the written consent of both parties. 

The
parties agree to amend terms of this Quality Agreement that must be amended in order that the Product continue to meet regulatory requirements of applicable regulatory agencies, as may exist from
time to time. 

If
an amendment to this Quality Agreement is proposed, the proposing party will circulate the proposed amendment to the appropriate contact person at Supplier and Wyeth for review and internal
approval. The appropriate contact person at Supplier and Wyeth is listed in Appendix 2 (Contacts and Responsibilities). 

5.     Term of Quality Agreement  

This
Quality Agreement shall commence on the Effective Date and shall remain in effect for as long as the Supplier supplies Product to Wyeth unless the Quality Agreement is terminated earlier in
accordance with the terms of this Quality Agreement. 

Either
party may terminate this Quality Agreement upon thirty (30) days written notice to the other party. 

6.     Use of Third-Parties  

Supplier
shall not use in any capacity the services of any third-party to manufacture, supply, package, label, inspect, test, release, handle and/or process Product for Wyeth unless Wyeth provides
prior written consent to Supplier for such. Before Wyeth grants any such written consent, Wyeth may require that Supplier enter into a written agreement with the third-party (the "Third-Party
Agreement") to the satisfaction of Wyeth. This Third-Party Agreement shall define the respective quality responsibilities of Supplier and the third-party and shall provide for confidentiality and
non-disclosure of all Wyeth confidential information requiring at least the same degree of protection for Wyeth's confidential information as the obligations of confidentiality and
non-disclosure that exist between Supplier and Wyeth. The Third-Party Agreement must be consented to by Wyeth in writing prior to its execution by Supplier and the third-party. 

33

 

Supplier
shall retain all obligations to Wyeth under this Quality Agreement, whether or not a third-party manufactures, supplies, packages, labels, inspects, tests, releases, handles and/or processes
the Product for Supplier. 

7.     Survival Clause  

All
regulatory obligations contained herein that are required of either party or both parties by an applicable regulatory authority shall survive termination of this Quality Agreement. 

8.     Assignment  

Supplier
shall not assign any or all of its rights or obligations under this Quality Agreement without Wyeth's prior written consent. Wyeth's consent shall not be required in connection with a merger,
consolidation, or a sale of all or substantially all of Supplier's assets or the subject matter of this Quality Agreement to another party (an "Assignment Transaction"). In the event of an Assignment
Transaction, Supplier shall provide written notice to Wyeth to the appropriate contact person indicated in Appendix 2. Wyeth shall have the right
to assign any or all of its rights or obligations under this Quality Agreement without the consent of Supplier. In the event of an assignment, the assigning party shall continue to be bound by all
pre-existing obligations under this Quality Agreement including all obligations of confidentiality and non-disclosure. 

9.     Resolution of Quality Issues  

Quality
related disagreements between Supplier and Wyeth that are not resolved in the normal course of business shall be brought to the attention to the appropriate contact person for notices at the
Supplier and Wyeth, in writing, as listed in Appendix 2(Contacts and Responsibilities). If both parties agree that a resolution of the
disagreement is reasonably possible, then both Supplier and Wyeth shall agree to work jointly to develop a strategy for such resolution. Supplier and Wyeth further agree to record such resolution in
writing. 

11.   Debarment  

Supplier
warrants and represents that it is not debarred under the Generic Drug Enforcement Act of 1992, 21 U.S.C. 335[a] (the "Generic Drug Enforcement Act"), and that it has
not been convicted of a crime for which it could be debarred under the Generic Drug Enforcement Act. In connection with the Product, the Supplier further warrants and represents, in that it shall not
use in any capacity the services of any person debarred under the Generic Drug Enforcement Act, or convicted of a crime for which a person can be debarred under the Generic Drug Enforcement Act. 

12.   Choice of Law: Jurisdiction/Miscellaneous  

This
Quality Agreement shall be construed and the relationship between the parties determined in accordance with the laws in the State of New Jersey, United States of America, without regard to the
conflicts of law principals thereof. Any and all disputes between the parties arising out of or related to this Quality Agreement shall be heard in the state and federal courts located in the State of
New Jersey, and the parties hereby consent and submit to the jurisdiction of such courts. 

All
appendices to this Quality Agreement are attached hereto and incorporated herein by reference. In this Quality Agreement, unless the contrary intention appears: (a) the words "including"
and "include" mean "including, but not limited to";(b) the singular includes the plural and vice versa; (c) a reference to a person or entity (including Supplier or Wyeth) includes a reference
to the person's executors, administrators, successors, substitutes and assigns; and (f) headings are for reference only and do not form part of this contract. 

34

   13.   Quality Responsibilities Table  

 Table Key: N = Not Applicable  

	§
	 	Responsibilities
	 	No Wyeth Supplier

	A.	 	Compliance Requirements	 	 	 	 	 	 
	1.01	 	Follow applicable regulations and current Good Manufacturing Practices, as well as locally imposed requirements.	 	 	 	X	 	X
	1.02	 	Manufacture, package, ship, store and test the Product and materials in an environment meeting the applicable GMP regulations, which is designed, constructed and maintained in a manner that a) permits the operation
therein to be performed under clean, sanitary and orderly conditions; b) permits the effective cleaning of all surfaces; and c) prevents the contamination of the Product and the addition of extraneous material to the Product.	 	 	 	 	 	X
	1.03	 	Manufacture the Product in adherence to applicable Board of Health submissions (such as Drug Master File, Device Master File, Product Applications).	 	 	 	 	 	X
	1.04	 	Maintain a valid manufacturing license covering manufacture of the Product.	 	 	 	 	 	X
	1.05	 	Operate in compliance with applicable environmental, occupational health and safety laws and regulations.	 	 	 	 	 	X
	1.06	 	Refrain from activity that could adversely affect quality of the Product.	 	 	 	X	 	X
	1.07	 	Notify Wyeth of requests for information, notices of violations or other communication from a government agency relating to environmental, occupational health and safety compliance that impact the Product.	 	 	 	 	 	X
	1.08	 	Have management controls in place to track and trend investigations and commitments.	 	 	 	 	 	X
	1.09	 	Maintain a quality unit that is independent of production that fulfills both quality assurance and quality control responsibilities.	 	 	 	 	 	X
	1.10	 	Disposition of Product by quality unit or Qualified Person (QP).	 	 	 	X	 	X
	1.11	 	Involve the quality unit in all Good Manufacturing Practices related matters.	 	 	 	 	 	X
	1.12	 	Notify Wyeth of key organizational and/or key personnel changes.	 	 	 	 	 	X
	1.13	 	Maintain internal Good Manufacturing Practices audit program.	 	 	 	 	 	X
	B.	 	Right to Audit	 	 	 	 	 	 
	2.01	 	Have the right to audit Supplier's facilities and systems, as they relate to the manufacture of Product, at mutually agreed upon times. Wyeth retains the right to conduct "for cause" audits as necessary.	 	 	 	X	 	 
	2.02	 	Schedule visits and/or requests for Product specific documents for review to assure continued adherence to the agreed upon manufacturing process, applicable current Good Manufacturing Practices and other applicable
requirements.	 	 	 	X	 	 
	2.03	 	Issue Supplier a confidential audit report summarizing audit observations.	 	 	 	X	 	 
	2.04	 	Issue responses to all observations in writing to Wyeth within thirty (30) days of receipt. Responses are to include timelines and plans for closure of all commitments.	 	 	 	 	 	X
	C	 	Regulatory Inspections and Exchanges	 	 	 	 	 	 
	3.01	 	Coordinate the activities necessary to ensure readiness prior to regulatory agency pre-approval inspections and maintain inspection readiness for all inspections.	 	 	 	X	 	X
	 	 	 	 	 	 	 	 	 

35

 

	3.02	 	Notify Wyeth within twenty-four (24) hours of any pending or ongoing regulatory authority inspection or communication related to the Product or the facilities used to produce, test or warehouse the Product. In the event
that the inspection is specific only to Product, Supplier shall permit a representative of Wyeth to be present during any such inspection.	 	 	 	 	 	X
	3.03	 	Provide copies to Wyeth by facsimile copy or electronically within seventy-two (72) hours of correspondences to and received from regulatory authorities (Boards of Health) related to Wyeth Product and related operations
performed by the Supplier.	 	 	 	 	 	X
	3.04	 	Provide a copy of the regulatory inspection report, deficiency letter, or regulatory compliance observations, response and related correspondence to Wyeth edited to exclude Supplier proprietary information within three
(3) days of receipt. Allow Wyeth to review and comment on the response, relevant to Product supplied to Wyeth, prior to submission of the response to the regulatory authority.	 	 	 	X	 	X
	3.05	 	Notify Supplier of any regulatory compliance observation received by Wyeth that pertains to operations performed by the Supplier and requires Supplier information.	 	 	 	X	 	 
	3.06	 	Provide requested information to Wyeth within ten (10) days of notification or as required to meet regulatory obligations.	 	 	 	 	 	X
	3.07	 	Provide Supplier with advance written notification of new or supplemental regulatory submission/application that impact the operations performed by the Supplier.	 	 	 	X	 	 
	D.	 	Regulatory Documentation	 	 	 	 	 	 
	4.01	 	Provide all necessary Letters of Authorization to Wyeth to permit reference to the Supplier's Drug Master File or Device Master File in the registration of the Product.	 	 	 	 	 	X
	4.02	 	Maintain the Drug Master File, Device Master File or regulatory applications, as applicable, in accordance with the regulations of the applicable regulatory authority.	 	 	 	 	 	X
	4.03	 	Notify Wyeth of any Drug Master File, Device Master File or regulatory application change as applicable before submitting the change to authority and prior to implementation.	 	 	 	 	 	X
	4.04	 	Upon request provide assistance in the preparation and review pertinent sections of new or supplemental regulatory applications where Wyeth owns the Product registration and submit comments to the proposed application to
Wyeth.	 	 	 	 	 	X
	4.05	 	Provide sections of Product registration relevant to manufacture of Product.	 	 	 	X	 	 
	E.	 	Animal Derived Materials	 	 	 	 	 	 
	5.01	 	Complete Wyeth's Materials Sourcing Questionnaire for raw materials and components.	 	 	 	 	 	X
	5.02	 	Have a program aligned with Wyeth requirements to evaluate and control the risk of Transmissible Spongiform Encephalopathy for raw materials and components.	 	 	 	 	 	X
	5.03	 	Supplier shall not use any animal derived materials without the prior notification of and approval by Wyeth. The foregoing restriction includes any animal derived materials used in the Product manufacturing process
including: (i) those used as machine lubricants and/or oils, and; (ii) any animal derived materials that have contact with Product.	 	 	 	 	 	X
	 	 	 	 	 	 	 	 	 

36

 

	5.04	 	Maintain appropriate records for each lot of animal derived material to ensure traceability. Where required by local regulations, the location where animals lived or were slaughtered (if applicable) must be
documented.	 	 	 	 	 	X
	F.	 	Buildings and Facilities	 	 	 	 	 	 
	6.01	 	Buildings and facilities used in the manufacture of the Product shall be designed, constructed and maintained to facilitate cleaning, maintenance and operations and to assure orderly placement of equipment and materials
to prevent mix-up and contamination as appropriate to the type and stage of manufacture.	 	 	 	 	 	X
	6.02	 	Ventilation systems will be designed and maintained to minimize the risk of contamination.	 	 	 	 	 	X
	6.03	 	Dispose of sewage, refuse and other waste of in a safe and timely manner following applicable environmental health and safety regulations.	 	 	 	 	 	X
	6.04	 	Maintain a set of current drawings for critical utilities including water, electricity, compressed gasses and air handling.	 	 	 	 	 	X
	6.05	 	Maintain and document an adequate pest control program.	 	 	 	 	 	X
	G.	 	Personnel and Training	 	 	 	 	 	 
	7.01	 	Provide sufficient training to meet obligations of this Quality Agreement.	 	 	 	 	 	X
	7.02	 	Provide adequate number of personnel qualified by appropriate training and experience to perform and supervise the manufacture, testing, packaging and disposition of the Product.	 	 	 	 	 	X
	7.03	 	Assure training is regularly conducted, assessed and documented by qualified individuals.	 	 	 	 	 	X
	7.04	 	Have written job descriptions for positions responsible for performing Good Manufacturing Practices related activities.	 	 	 	 	 	X
	7.05	 	Assure that non-employees, including consultants, advising on the manufacture and control of the Product have sufficient education, training, and experience to advise on the subject for which they are retained.
Non-employees will be supervised as required and trained in Good Manufacturing Practices.	 	 	 	 	 	X
	H.	 	Sub-Contracting and Testing	 	 	 	 	 	 
	8.01	 	If Supplier sub-contracts any laboratory testing or manufacturing work (or like) to a third-party contract laboratory or third- party manufacturer (or the like) (a "Sub-Contractor"), Supplier shall require that such
Sub-Contractor shall operate in compliance with current Good Manufacturing Practices, compendia requirements and any other applicable regulations.	 	 	 	 	 	X
	8.02	 	Not engage any Sub-Contractor without the prior written consent of Wyeth.	 	 	 	 	 	X
	8.03	 	Maintain Sub-Contactor as qualified following approved procedures according to a schedule.	 	 	 	 	 	X
	8.04	 	If Supplier engages a Sub-Contractor, Supplier shall cause Sub-Contractor to grant access to Wyeth (or Wyeth's assignee) and/or any applicable regulatory authority for purposes of any Wyeth and/or regulatory authority
audits on the same terms and conditions as such access is granted to Wyeth and/or any applicable regulatory authority by Supplier under the terms of this Quality Agreement (including Section 2, Right to Audit and Section 3 Regulatory Inspections and
Exchanges as provided herein above) and/or the terms and conditions of any other applicable agreement between Supplier and Wyeth.	 	 	 	 	 	X
	 	 	 	 	 	 	 	 	 

37

 

	I.	 	Change Control	 	 	 	 	 	 
	9.01	 	Have approved written procedures for control of changes impacting the Product including but not limited to manufacturing components or process, packaging materials, labeling, computer hardware/software, Product
specifications, and test methods. Include in written procedures the process and criteria for customer notification and approval, follow up and closure of changes.	 	 	 	 	 	X
	9.02	 	Notify Wyeth of all changes to facility, process, test methods, quality systems and specifications that impact Product identity, strength, safety, potency, purity, stability regulatory status or validation/qualification.
Allow time for Wyeth to comment and approve or reject changes prior to implementation. In the case of emergency changes, Supplier shall follow the procedures defined in Section 12 (Investigations).	 	 	 	 	 	X
	9.03	 	Provide copies of change control documentation such as supporting data, validation/qualification reports and change control forms for changes impacting Product as requested by Wyeth.	 	 	 	 	 	X
	9.04	 	Have changes reviewed and approved by the Supplier's quality unit.	 	 	 	 	 	X
	9.05	 	Supplier and Wyeth shall establish a strategy to secure regulatory approvals as necessary, and shall mutually agree on an implementation timeline.	 	 	 	X	 	X
	J.	 	Validation/Qualification	 	 	 	 	 	 
	10.01	 	Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved
by the quality unit.	 	 	 	 	 	X
	10.02	 	Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents to Wyeth upon request.	 	 	 	 	 	X
	10.03	 	Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance
Qualification (PQ)).	 	 	 	 	 	X
	10.04	 	Validate/qualify computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product. Procedures must be in place to assure the integrity, archival, retrieval and
destruction of the electronic data that comply with applicable regulations.	 	 	 	 	 	X
	10.05	 	Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified.	 	 	 	 	 	X
	10.06	 	Develop and execute a plan for process and method validation/qualification including definition of roles and responsibilities between Supplier and Wyeth for performing technology transfers.	 	 	 	X	 	X
	 	 	 	 	 	 	 	 	 

38

 

	10.07	 	Where method validation is performed by Supplier:	 	 	 	 	 	 
	 	 	• Supplier shall write method validation protocol,	 	 	 	 	 	X
	 	 	• Supplier and Wyeth shall review and approve method validation protocol,	 	 	 	X	 	X
	 	 	• Supplier shall execute method validation protocol,	 	 	 	 	 	X
	 	 	• Supplier shall write method validation report, and	 	 	 	 	 	X
	 	 	• Supplier and Wyeth shall review and approve method validation report.	 	 	 	X	 	X
	10.08	 	For process validation:	 	 	 	 	 	 
	 	 	• Supplier shall write process validation protocol,	 	 	 	 	 	X
	 	 	• Supplier and Wyeth shall review and approve process validation protocol,	 	 	 	X	 	X
	 	 	• Supplier shall execute process validation protocol,	 	 	 	 	 	X
	 	 	• Supplier shall write process validation report, and	 	 	 	 	 	X
	 	 	• Supplier and Wyeth shall review and approved validation reports.	 	 	 	X	 	X
	10.09	 	Validate/qualify all manufacturing processes, product formulation, mixing operations and hold times for the formulation process unless otherwise agreed by Wyeth.	 	 	 	 	 	X
	10.10	 	Qualify time limitations for each phase of production.	 	 	 	 	 	X
	10.11	 	Evaluate protocol deviations encountered during validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies.	 	 	 	 	 	X
	10.12	 	Evaluate validated/qualified systems and processes periodically to verify they are still operating in a valid manner.	 	 	 	 	 	X
	K	 	Preventative Maintenance and Calibration	 	 	 	 	 	 
	11.01	 	Maintain calibration and preventive maintenance procedures and schedules for equipment/instruments using in the manufacture, packaging, testing and validation/qualification of the Product. Include calibration tagging
where appropriate.	 	 	 	 	 	X
	11.02	 	Document and review (including calibration performed by Sub-Contractor) manufacturing and laboratory equipment/instrumentation calibration data and provide to Wyeth upon request.	 	 	 	 	 	X
	L	 	Investigations	 	 	 	 	 	 
	12.01	 	Have appropriate procedures for the identification, investigation, reporting, tracking, trending and closure of deviations. Deviations include but are not limited to known lab errors, atypical results and
Out-of-Specification results that occur during the manufacture and testing of the Product, including stability testing (as applicable).	 	 	 	 	 	X
	12.02	 	Document and notify Wyeth of any deviation affecting the quality of the Product or any deviation outside of Product registration, if applicable:

    (i) within three (3) days, and

    (ii) prior to release of product.	 	 	 	 	 	X
	12.03	 	Notify Wyeth within twenty-four (24) hours of first knowledge of all Out-of-Specification results generated during stability testing of Product.	 	 	 	 	 	X
	12.04	 	Provide investigation documentation to Wyeth upon request.	 	 	 	 	 	X
	12.05	 	Assist Supplier in investigations when Wyeth deems appropriate.	 	 	 	X	 	 
	12.06	 	Complete investigations within thirty (30) days of commencement. Supplier shall not extend any investigation beyond the original thirty (30) day period without the written consent of Wyeth.	 	 	 	X	 	X
	12.07	 	Complete corrective action commitments resulting from investigation closure within the planned timeframe.	 	 	 	 	 	X
	 	 	 	 	 	 	 	 	 

39

 

	M	 	Documentation and Records	 	 	 	 	 	 
	13.01	 	Document all required process and testing steps at the time such process or testing step is executed.	 	 	 	 	 	X
	13.02	 	Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. System should address revising documents based on requested document changes provided by
Wyeth (such as test methods and specifications).	 	 	 	X	 	X
	13.03	 	Supplier's quality unit must review and approval all Good Manufacturing Practices records.	 	 	 	 	 	X
	13.04	 	Retain, archive and destroy all Good Manufacturing Practices documents and data pertaining to Services performed for Wyeth in accordance with Wyeth and regulatory requirements as defined below:

• keep all original analytical records including test results, records, charts, computer reports and graphs for a period of 5 years,

• keep all validation and technical transfer documents in connection with Service performed for Wyeth indefinitely,

• keep original investigation and out of specification report documentation in connections with Services performed for Wyeth for five years, and

• notify Wyeth prior to destruction of records and,

• Insure that original records are protected from fire and water damage in a limited access area.	 	 	 	 	 	X
	13.05	 	Review and approve Master Batch Records.	 	 	 	X	 	X
	13.06	 	Have all executed batch related records reviewed and approved by Supplier's quality unit prior to batch release. Assure records have a unique identification number.	 	 	 	 	 	X
	 	 	 	 	 	 	 	 	 

40

 

	13.07	 	For laboratory control records, include complete data derived from all tests conducted to ensure compliance with specifications. These records will contain the date and the signature of a second qualified person showing
review and verification of the records.	 	 	 	 	 	X
	13.08	 	Provide copies of documents or records to Wyeth upon request.	 	 	 	 	 	X
	13.09	 	Maintain a document control system for specifications, including: raw materials, Product labeling, packaging materials and other materials that would likely affect Product quality.	 	 	 	 	 	X
	13.10	 	Maintain a document control system for Standard Operating Procedures.	 	 	 	 	 	X
	13.11	 	Maintain a document control system for specifications of reagents, solutions and laboratory standards, as appropriate.	 	 	 	 	 	X
	13.12	 	Provide a complete Certificate of Analysis for the Product, containing at minimum the following information:

• Wyeth Product number,

• Supplier Product number, (if applicable)

• Supplier lot number,

• Name of Product,

• Name of the test,

• Test method,

• Specification limit,

• Expiration date (if applicable)

• Test result (as a numerical value, unless designated Pass/Fail in the specification limit), including re-test results if required,

• Quality Assurance approval and date,

• Manufacturing site (name and address), and Manufacturing date.	 	 	 	 	 	X
	13.13	 	Provide a document certifying Product was manufactured in a current Good Manufacturing Practices compliant facility and was tested in accordance with and meets specifications.	 	 	 	 	 	X
	N	 	Annual Product Reviews	 	 	 	 	 	 
	14.01	 	Have procedures to conduct and document annual product reviews on a scheduled basis as agreed to by Wyeth.	 	 	 	 	 	X
	14.02	 	Prepare Annual Product Review that includes at a minimum;

• Documentation of trends,

• Corrective action (if any),

• Date of review,

• Signatures/title of the reviewers,

• Product identification,

• Review period,

• Batch records (including reworks),

• Applicable change control records,

• Returned or salvage Product records,

• Product investigation records,

• Non-conforming materials' reports, and

• Batch record deviations.	 	 	 	 	 	X
	14.03	 	Provide copies of Annual Product Review to Wyeth	 	 	 	 	 	X
	O	 	Annual Product Report (if applicable)	 	 	 	 	 	 
	15.01	 	Provide data to Wyeth necessary for the submission of Annual Product Reports by a mutually agreed upon date.	 	 	 	 	 	X
	15.02	 	Submit data in a mutually agreed to format.	 	 	 	 	 	X
	 	 	 	 	 	 	 	 	 

41

 

	P	 	Production and In Process Controls, Packaging and Labeling	 	 	 	 	 	 
	16.01	 	Have approved written procedures in place for qualification (including audits) of suppliers that provide GMP-materials and services.	 	 	 	 	 	X
	16.02	 	Make no changes in the sourcing of production materials (raw materials, packaging materials, processing aids) from the approved supplier list without prior written consent from Wyeth.	 	 	 	 	 	X
	16.03	 	Implement and document specifications for raw materials, packaging materials, and Product labeling and processing aids that would likely affect Product quality pursuant to specification documentation provided by
Wyeth.	 	 	 	 	 	X
	16.04	 	Have approved written procedures for all required in-process sampling and testing.	 	 	 	 	 	X
	16.05	 	Procure, test (as required), and disposition raw materials, components, packaging and labeling used in manufacture and packaging of Product.	 	 	 	 	 	X
	16.06	 	Document actual yields for the Product, and evaluate actual yields versus theoretical or Wyeth in-process yield control limits.	 	 	 	 	 	X
	16.07	 	Notify Wyeth in the event that there is a change in product category manufactured in the same facility and equipment as Wyeth's Product (such as hazardous, deleterious, potent, sensitizing materials, for example:
Penicillin).	 	 	 	 	 	X
	16.08	 	Provide Product expiration period to Supplier for assigning Product expiry dates.	 	 	 	X	 	 
	16.09	 	Have appropriate automatic inspection devices in place to assure the correct product is packaged, the correct labeling is utilized, and any inline marking is completely and accurately located.	 	 	 	 	 	X
	16.10	 	Include in shipper label:

• name and address of the manufacturer,

• unique identifying code,

• batch number,

• quantity of contents,

• storage and special transport conditions,

• manufacturing date,

• expiry date, and

• any special requirements (if applicable).	 	 	 	 	 	X
	16.11	 	Develop all labeling in accordance with applicable regulation (including for the country intended for distribution) and Product license.	 	 	 	X	 	X
	16.12	 	Develop all Product labeling including translations into languages other than standard (US) American English.	 	 	 	X	 	X
	16.13	 	Have all Product labeling (including any translations) approved by Wyeth prior to use.	 	 	 	 	 	X
	16.14	 	Include a representative label in the batch record.	 	 	 	 	 	X
	16.15	 	Establish and maintain a program for environmental monitoring including tracking and trending processes.	 	 	 	 	 	X
	16.16	 	Retain reserve samples of raw materials, packaging materials and Product label, intermediates (if applicable) and final Product in accordance with Supplier's written procedures.	 	 	 	 	 	X
	 	 	 	 	 	 	 	 	 

42

 

	Q	 	Process Equipment	 	 	 	 	 	 
	17.01	 	Process equipment must be uniquely identified, status tagged and managed with an equipment history log or equivalent system. Process lines will be appropriately identified.	 	 	 	 	 	X
	17.02	 	Use appropriate food grade machine lubricants and oils that contain no animal derived materials.	 	 	 	 	 	X
	17.03	 	Maintain a current set of "as-built" drawings for equipment and facilities.	 	 	 	 	 	X
	R	 	Reprocess	 	 	 	 	 	 
	18.01	 	Approve or disapprove all reprocessing steps. Document approval in specific reprocessing protocols or special batch record instructions. Reprocessing is defined as a repetition of a step (for example, redrying, remilling)
using the same equipment and techniques as specified in the original procedure. In addition, an extension of an approved process step is also regarded as reprocessing.	 	 	 	X	 	X
	18.02	 	Perform reprocessing only where specified in protocol or specific batch record instructions approved by Wyeth.	 	 	 	 	 	X
	S	 	Rework	 	 	 	 	 	 
	19.01	 	Have a protocol or procedure that has been approved by both Wyeth and the Supplier for Product requiring rework describing the rationale and justification for the rework processes. Rework is a manufacturing step involving
a technique or technology that is not part of the approved process sequence.	 	 	 	X	 	X
	19.02	 	Approve or disapprove Product requiring rework.	 	 	 	X	 	 
	T	 	Laboratory Controls	 	 	 	 	 	 
	20.01	 	Have written procedures for sample management, identification, testing, disposition and recording, approval, tracking, storage, retention and disposal of laboratory data.	 	 	 	 	 	X
	20.02	 	Hold samples and dispose of as required by specifications and procedures.	 	 	 	 	 	X
	20.03	 	Destroy samples and sample packaging in a secure and legal manner that prevents unauthorized use or diversion in accordance with Suppliers procedures. Maintain destruction records.	 	 	 	 	 	X
	20.04	 	Have approved written procedures and document the preparation and use of reference standards, reference materials, reagents, and solutions including qualification/requalification of use period.	 	 	 	 	 	X
	20.05	 	Mutually agree on source, grade and characterization of reference standards/materials.	 	 	 	X	 	X
	20.06	 	Have appropriate specifications and test procedures for the Product, which are consistent with the applicable, approved filing and/or compendia monograph.	 	 	 	X	 	X
	20.07	 	Test Product in accordance with qualified or validated methods as appropriate and with specifications using calibrated, qualified equipment.	 	 	 	 	 	X
	20.08	 	Verify compendia test methods (i.e. USP, EP, BP, JP). Supply a certificate of equivalency or verification report to Wyeth, if applicable. Follow approved change to test procedures for changing test methods.	 	 	 	 	 	X
	20.09	 	Transfer all test methods validated by Wyeth according to protocols approved by Supplier and Wyeth.	 	 	 	X	 	X
	20.10	 	Ensure method transfers have been completed and approved prior to the generation of any GMP test data.	 	 	 	 	 	X
	 	 	 	 	 	 	 	 	 

43

 

	U.	 	Retest	 	 	 	 	 	 
	21.01	 	Have prior written consent from Wyeth's Quality Assurance Unit for retesting the product (excluding routine stability testing).	 	 	 	 	 	X
	21.02	 	Perform retesting in accordance with approved protocols or procedures.	 	 	 	 	 	X
	V.	 	Stability (if applicable to service being provided)	 	 	 	 	 	 
	22.01	 	Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures.	 	 	 	 	 	X
	22.02	 	Store stability samples in market containers under International Conference on Harmonization storage conditions.	 	 	 	 	 	X
	22.03	 	Write and review stability protocol and reports.	 	 	 	 	 	X
	22.04	 	Approve stability protocols prior to executing stability studies.	 	 	 	X	 	X
	22.05	 	Execute stability studies.	 	 	 	 	 	X
	22.06	 	Approve stability reports.	 	 	 	X	 	X
	22.07	 	Provide approved stability protocols and stability reports to Wyeth upon request.	 	 	 	 	 	X
	22.08	 	Assign and approve appropriateness of storage conditions and retest or expiry date base on stability data.	 	 	 	X	 	X
	22.09	 	Place the first three commercial production batches and at least one batch per year on stability or as required by applicable regulatory agencies.	 	 	 	X	 	X
	22.10	 	Perform stability testing of reworked/reprocessed batches or those associated with investigations or revalidations/requalifications as required by Wyeth.	 	 	 	 	 	X
	W.	 	Storage and Distribution	 	 	 	 	 	 
	23.01	 	Validate/qualify and maintain storage facilities appropriate for conditions specified on the Product label. Maintain records of any critical parameters.	 	 	 	 	 	X
	23.02	 	Establish and maintain an environmental monitoring program including trending activities to assure adherence to specified Product, raw material, packaging material and component storage conditions (such as temperature and
humidity).	 	 	 	 	 	X
	23.03	 	Have validated/qualified systems for controlling quarantined, rejected or recalled materials and segregate rejected or recalled materials.	 	 	 	 	 	X
	23.04	 	Provide Product Material Safety Data Sheet or equivalent.	 	 	 	 	 	X
	23.05	 	Ship Product in accordance with Wyeth qualified transportation requirements.	 	 	 	 	 	X
	23.06	 	In the event of an environmental excursion affecting Product, notify Wyeth within three (3) business days and make subsequent investigation available to Wyeth upon request.	 	 	 	 	 	X
	23.07	 	Have a system in place for assuring unreleased Product is not shipped unless authorized by Wyeth quality unit.	 	 	 	X	 	X
	X.	 	Control, Disposal and Destruction of Production Materials	 	 	 	 	 	 
	24.01	 	Have a procedure for the access, control, reconciliation, disposition, disposal, and destruction of production materials proprietary to Wyeth or bearing Wyeth proprietary information used in the Product manufacture,
packaging and labeling that include but is not limited to:

• Active Pharmaceutical Ingredient

• Tooling, dies, printing rolls, plates and associated drawings used in the manufacturing of Product.

• Wyeth printed components and materials used to print such component, including but not limited to: printed components, containers, closures, tools, dies, plates, drawings and artwork including all electronic files.	 	 	 	 	 	X
	24.02	 	Dispose and destroy production materials in a secure and legal manner that prevents unauthorized use or diversion in compliance with environment regulations. Maintain destruction records.	 	 	 	 	 	X
	 	 	 	 	 	 	 	 	 

44

 

	Y.	 	Complaints	 	 	 	 	 	 
	25.01	 	Have written procedures in place to document, investigate and manage all product quality related complaints.	 	 	 	X	 	X
	25.02	 	Where Wyeth is the Product registration holder or where Product manufactured for Wyeth is an Over the Counter Pharmaceutical, Dietary Supplement or Infant Nutritional;	 	 	 	 	 	 
	 	 	• Supplier shall notify Wyeth within 24 hours of Product complaints received by Supplier that impact quality, purity, safety and effectiveness of distributed Product that are likely to result in a field alert, BPDR
and/or recall,	 	 	 	 	 	X
	 	 	• Wyeth shall conduct and complete complaint investigation,	 	 	 	X	 	 
	 	 	• Supplier shall assist in investigations of Product related complaints, as requested by Wyeth and report progress of investigation to Wyeth within 10 days,	 	 	 	 	 	X
	 	 	• Wyeth shall retain complaint investigation records and evaluate trends and severity, and	 	 	 	X	 	 
	 	 	• Supplier shall implement corrective actions associated with manufacture of Product.	 	 	 	 	 	X
	25.03	 	Where the Supplier is the Product registration holder;	 	 	 	 	 	 
	 	 	• Wyeth shall notify Supplier within 24 hours of Product complaints that impact quality, purity, safety and effectiveness of distributed product that are likely to result in a field alert, BPDR and/or recall,
	 	 	 	X	 	 
	 	 	• Supplier shall conduct and complete complaint investigation,	 	 	 	 	 	X
	 	 	• Wyeth shall assist in investigations of Product related complaints, as requested by Wyeth and report progress of investigation to Supplier within 10 days,	 	 	 	X	 	 
	 	 	• Supplier shall retain complaint investigation records and evaluate trends and severity, and	 	 	 	 	 	X
	 	 	• Supplier shall implement corrective actions as necessary.	 	 	 	 	 	X
	25.04	 	[NOTE TO AUTHOR: Where the business arrangement is other than defined in sections 25.02 and 25.03, (for example; some co-marketing and co-promotion arrangements), the author shall consult Legal to further define the
responsibilities for Complaints.	 	 	 	N	 	A
	25.05	 	NOTE TO AUTHOR: Contact by Global Safety, Surveillance & Epidemiology (GSSE) Contractual Agreements department who shall provide adverse experience language upon request. This may include an additional appendix
to this Quality Agreement. Attached to the Supply Agreement	 	 	 	N	 	A
	 	 	 	 	 	 	 	 	 

45

 

	Z.	 	Field Alerts, Biological Product Deviation Reports and Recalls	 	 	 	 	 	 
	26.01	 	Where Wyeth is the Product registration holder or where Product manufactured for Wyeth is an Over the Counter Pharmaceutical, Dietary Supplement or Infant Nutritional;	 	 	 	 	 	 
	 	 	• Wyeth shall have approved procedures for issuing field alerts, biological product deviation reports (as applicable) and recall that address the decision making process, correspondence with regulatory agencies
management of recalls, and reconciliation of returned Product,	 	 	 	X	 	 
	 	 	• Wyeth shall facilitate the process for determining the need to issue field alerts, biological product deviation reports or recalls,	 	 	 	X	 	 
	 	 	• Supplier shall participate in the investigation to make the decision to issue field alerts, biological product deviation reports or recalls,	 	 	 	 	 	X
	 	 	• Supplier shall review correspondence for submission to regulatory agency, as requested by Wyeth,	 	 	 	 	 	X
	 	 	• Wyeth shall issue correspondence to regulatory agencies, and	 	 	 	X	 	 
	 	 	• Wyeth shall manage recall and reconciliation of returned Product.	 	 	 	X	 	 
	26.02	 	Where the Supplier is the Product registration holder:	 	 	 	 	 	 
	 	 	• Supplier shall have approved procedures for issuing field alerts, biological product deviation reports (as applicable) and recall that address the decision making process, correspondence with regulatory agencies
management of recalls, and reconciliation of returned Product,	 	 	 	 	 	X
	 	 	• Supplier shall facilitate the process for determining the need to issue field alerts, biological product deviation reports or recalls,	 	 	 	 	 	X
	 	 	• Wyeth shall participate in the investigation to make the decision to issue field alerts, biological product deviation reports or recalls,	 	 	 	X	 	 
	 	 	• Supplier and Wyeth shall make final decision to issue field alerts, Biological Product Deviation Reports or recalls,	 	 	 	Nk	 	X
	 	 	• Supplier shall review correspondence for submission to regulatory agency, as requested by Wyeth,	 	 	 	 	 	X
	 	 	• Supplier shall issue correspondence to regulatory agencies, and	 	 	 	 	 	X
	 	 	• Wyeth shall manage recall and reconciliation of returned Product.	 	 	 	X	 	 
	26.03	 	Purposely left blank	 	 	 	 	 	 

46

   APPENDIX 1: (Definition of Product)  

"Product" shall mean the following:  

A Metered Dose Inhaler containing epinephrine as the active ingredient and Approved CFCs as propellant, which meets the
Specifications.

47

   APPENDIX 2: (Contacts and Responsibilities)  

	 
	 	Supplier
	 	Wyeth

	 	 	Quality Assurance	 	Quality Assurance
	

	

Name	
 	

 	
 	

 
	

	

Title	
 	

 	
 	

 
	

	

Phone/Fax	
 	

 	
 	

 
	

	

Address

(mail/delivery)	
 	

 	
 	

 
	

	

Electronic	
 	

 	
 	

 
	

	

 	
 	

Quality Assurance	
 	

Quality Assurance
	

	

Name	
 	

 	
 	

 
	

	

Title	
 	

 	
 	

 
	

	

Phone/Fax	
 	

 	
 	

 
	

	

Address

(mail/delivery)	
 	

 	
 	

 
	

	

Electronic	
 	

 	
 	

 
	

	

 	
 	

Account Manager	
 	

Commodity Manager
	

	

Name	
 	

 	
 	

 
	

	

Title	
 	

 	
 	

 
	

	

Phone/Fax	
 	

 	
 	

 
	

	

Address

(mail/delivery)	
 	

 	
 	

 
	

	

Electronic	
 	

 	
 	

 
	

48

 
APPENDIX 2: Page 2 (Contacts and Responsibilities)  

        The Contact Person for Notices should be the Head of the Quality Division or equivalent in each company.

Contact Person for Notices  

(including Notices of Amendment, Assignment,

Termination, Resolution of Quality Issues)  

	 
	 	 
	 	 

	 	 	Supplier	 	Wyeth
	

	

Name	
 	

 	
 	

 
	

	

Title	
 	

 	
 	

 
	

	

Phone/Fax	
 	

 	
 	

 
	

	

Address

(mail/delivery)	
 	

 	
 	

 
	

	
With a Copy to:	
 	

 	
 	

 
	

 	
 	
Supplier	
 	

Wyeth
	

	

Name	
 	

 	
 	

 
	

	

Title	
 	

 	
 	

 
	

	

Phone/Fax	
 	

 	
 	

 
	

	

Address

(mail/delivery)	
 	

 	
 	

 
	

	

Electronic	
 	

 	
 	

 
	

49

   EXHIBIT C  

Technology Transfer Plan for Primatene Mist ® and Costs  

[***]  

[***] Certain information comprising 10 pages has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions. 

50

   EXHIBIT D  

Issued Purchase Orders  

51

 

  

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

52

 

  

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

53

   EXHIBIT E  

List of Equipment and Corrective Measures for Manufacture  

[***]  

[***] Certain information comprising 2 pages has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions. 

54

   EXHIBIT F  

Pre-launch Activities for Manufacture

under ARMSTRONG's ANDA  

[***]  

[***] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. 

55

   EXHIBIT G  

Criteria for Water System  

Purified Water USP System  

	A.
	Armstrong
Pharmaceuticals will install a Purified Water USP System to meet the quality specifications set forth by Wyeth in a memo dated June 2, 2004 from Mark Knappe of Wyeth
to Ed Shaughnessy of Armstrong Pharmaceuticals.

	B.
	If
the water system to be installed by Armstrong Pharmaceuticals is not completed (i.e. validated) prior to manufacture of process capability batches, stability batches, or process
validation batches, Armstrong Pharmaceuticals will use Water for Injection (WFI) water sourced from a third party for compounding those batches.

	C.
	Wyeth
will have an opportunity to review prior to Armstrong Pharmaceuticals final approval the following Documents as they are generated for the Purified Water USP Systems:

	a.
	Design
Specifications and Requirements for System

	b.
	Piping
and Instrumentation Diagram(s) PIDs for System

	c.
	Standard
Operating Procedures (SOPs) for Operation, Cleaning and Maintenance of the System

	d.
	Preventative
Maintenance Schedule for the System

	e.
	Installation
and Operation Qualification Validation Protocols and Final Reports

	f.
	Performance
Qualification Validation Protocols and Final Reports

	D.
	Armstrong
Pharmaceuticals will provide Wyeth with periodic project updates on the design, installation, and validation of the Purified Water USP System to the WCH Project Management
contact for the project.

	E.
	After
completion of validation of the Purified Water USP System, Armstrong Pharmaceuticals will make available, at the request of Wyeth, the following data and information:

	a.
	Routine
Monitoring Data (test results) on water quality

	b.
	Investigation
Reports on water quality failures (out of specification results)

	c.
	Annual
review of the water system performance

	F.
	Water
System shall be installed and validated by no later than December 31, 2004. 

56

   EXHIBIT H  

Adverse Experience Reporting Procedures—WYETH's NDA  

The
Parties agree to comply with any and all governmental laws, regulations and orders that are applicable now and in the future in connection with adverse experience collection and reporting on the
Product. 

WYETH
shall be solely responsible for all pharmacovigilance activities regarding Product manufactured by ARMSTRONG for WYETH, including but not limited to: adverse experience or adverse drug reaction
reporting including literature review and associated reporting; AE/ADR follow-up reporting; preparation and submission of all safety reports to the FDA as required per US Code of Federal
Regulations (CFR), title 21 § 314.80; maintaining the safety database; all interactions with health authorities; periodic submissions; labeling modifications; safety monitoring and
detection and safety measures (eg, Dear Doctor Letter, restriction on distribution). 

Definitions.    The following definitions have been drafted in accordance with United States Code of Federal Regulations (CFR), title 21 as
stated now and in the future and apply to this Agreement. 

	(a)
	An
adverse experience (AE) is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a person
administered the Product or in a clinical study. The event or experience does not need to be causally related to the Product or clinical study. An AE includes, but is not limited to:

	•
	Any
clinically significant worsening of a pre-existing condition;

	•
	An
AE occurring from Product overdose (ie, a dose higher than that prescribed by a healthcare professional for clinical reasons, or a dose higher than that described on the
Product label) whether accidental or intentional;

	•
	An
AE occurring from abuse (eg, use for non-clinical reasons) of the Product;

	•
	An
AE occurring from discontinuation of the Product (Product withdrawal; and

	•
	Any
failure of expected pharmacological action.

	(b)
	Adverse
drug reaction (ADR) is defined as: 

In
the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: 

"All
noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions." 

The
phrase "responses to medicinal products" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, (ie, the relationship cannot be
ruled out). 

Regarding
marketed medicinal products: 

An
ADR is a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, therapy of disease, or for modification of physiological
function. 

	(c)
	Certain
information, while not meeting the above definition of an AE, shall nonetheless be exchanged. This information, hereinafter referred to as "Other Information Reportable to
WYETH", includes:

	•
	Abuse
(eg, use for non-clinical reasons) with or without an AE; 

57

 

	•
	Inadvertent
or accidental exposure, with or without an AE;

	•
	An
unexpected therapeutic or clinical benefit from use of the product;

	•
	A
case involving a pregnancy exposure to the product;

	•
	Overdose
with or without an AE;

	•
	Medication
errors without an AE;

	•
	Any
failure of expected pharmacological action; or

	•
	AEs
of special interest as designated by Wyeth or regulatory authority. 

Exchange.    To the extent ARMSTRONG becomes aware of or receives any information, including follow-up, regarding an AE/ADR or
Other Information Reportable to WYETH associated with the use of the Product manufactured by ARMSTRONG for WYETH, ARMSTRONG shall promptly provide WYETH with such information within  five (5) calendar days of the date received by ARMSTRONG. If there is any doubt whether the AE/ADR came from Product manufactured by ARMSTRONG
for WYETH, ARMSTRONG shall treat the AE/ADR as such and forward the AE/ADR to WYETH. 

AE/ADR
information and Other Information Reportable to WYETH received by ARMSTRONG shall be transmitted by: 

	a.
	Facsimile:
610-989-5544 or

	b.
	Overnight
courier to: 

Global
Safety Surveillance & Epidemiology

Wyeth Research

GSSE Triage Unit

Dock E

500 Arcola Road

Collegeville, PA 19426 

For
purposes of case reconciliation, ARMSTRONG shall send a list of all AE/ADR information regarding the Product manufactured by ARMSTRONG for WYETH with local tracking numbers transmitted over the
previous month to WYETH. Reconciliation of the prior month shall be completed by the end of the following month. If discrepancies are noted, either by reconciliation or other means, the responsible
individuals at ARMSTRONG and WYETH shall handle the matter on a case-by-case basis until satisfactory resolution. 

The
Parties agree to meet after the effective date to establish a detailed Safety Agreement, if necessary, outlining the responsibilities of each Party in connection with collecting and reporting
adverse events as well as Literature Reports, Follow-up Reports, Reconciliation, US Periodic Reports, Periodic Safety Update Reports, Product Labeling Activities, and Pharmacovigilance
related to the Products which will supersede this Exhibit H. 

58

   EXHIBIT I  

Adverse Experience Reporting Procedures ARMSTRONG's ANDA  

The
Parties agree to comply with any and all governmental laws, regulations and orders that are applicable now and in the future in connection with adverse experience collection and reporting on the
Product. 

ARMSTRONG
shall be solely responsible for all pharmacovigilance activities regarding the Product manufactured by ARMSTRONG for ARMSTRONG including but not limited to: adverse experience or adverse
drug reaction reporting including literature review and associated reporting; AE/ADR follow-up reporting; preparation and submission of all safety reports to the FDA as required per US
Code of Federal Regulations (CFR), title 21 § 314.80; maintaining the safety database for Product manufactured by ARMSTRONG for ARMSTRONG; all interactions with health authorities;
periodic submissions; labeling modifications; safety monitoring and detection and safety measures (eg, Dear Doctor Letter, restriction on distribution). 

WYETH
shall be solely responsible for all pharmacovigilance activities regarding the Product manufactured by ARMSTRONG for WYETH including but not limited to: adverse experience or adverse drug
reaction reporting including literature review and associated reporting; AE/ADR follow-up reporting; preparation and submission of all safety reports to the FDA as required per US Code of
Federal Regulations (CFR), title 21 § 314.80; maintaining the safety database for Product manufactured by ARMSTRONG for WYETH; all interactions with health authorities; periodic
submissions; labeling modifications; safety monitoring and detection and safety measures (eg, Dear Doctor Letter, restriction on distribution). 

Definitions.    The following definitions have been drafted in accordance with United States Code of Federal Regulations (CFR), title 21 as
stated now and in the future and apply to this Agreement. 

	(a)
	An
adverse experience (AE) is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a person
administered the Product or in a clinical study. The event or experience does not need to be causally related to the Product or clinical study. An AE includes, but is not limited to:

	•
	Any
clinically significant worsening of a pre-existing condition;

	•
	An
AE occurring from Product overdose (ie, a dose higher than that prescribed by a healthcare professional for clinical reasons, or a dose higher than that described on the
Product label) whether accidental or intentional;

	•
	An
AE occurring from abuse (eg, use for non-clinical reasons) of the Product;

	•
	An
AE occurring from discontinuation of the Product (Product withdrawal; and

	•
	Any
failure of expected pharmacological action.

	(b)
	Adverse
drug reaction (ADR) is defined as: 

In
the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: 

"All
noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions." 

The
phrase "responses to medicinal products" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, (ie, the relationship cannot be
ruled out). 

59

 

Regarding
marketed medicinal products: 

An
ADR is a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, therapy of disease, or for modification of physiological
function. 

	(c)
	Certain
information, while not meeting the above definition of an AE, shall nonetheless be exchanged. This information, hereinafter referred to as "Other Information Reportable to
Other Party", includes:

	•
	Abuse
(eg, use for non-clinical reasons) with or without an AE;

	•
	Inadvertent
or accidental exposure, with or without an AE;

	•
	An
unexpected therapeutic or clinical benefit from use of the product;

	•
	A
case involving a pregnancy exposure to the product;

	•
	Overdose
with or without an AE;

	•
	Medication
errors without an AE;

	•
	Any
failure of expected pharmacological action; or

	•
	AEs
of special interest as designated by either Party or regulatory authority. 

Exchange.    To the extent WYETH becomes aware of or receives any information, including follow-up regarding an AE/ADR or Other
Information Reportable to Other Party associated with the use of the Product manufactured by ARMSTRONG for ARMSTRONG, WYETH shall promptly provide ARMSTRONG with the source information  within five (5) calendar
days of the date received by WYETH. If there is any doubt whether the AE/ADR came from Product manufactured by ARMSTRONG
for ARMSTRONG, WYETH shall treat the AE/ADR as such and forward the AE/ADR to ARMSTRONG. 

AE/ADR
information and Other Information Reportable to Other Party received by WYETH shall be transmitted by: 

	(a)
	Facsimile:    or

	(b)
	Overnight
courier to: 

To
the extent ARMSTRONG becomes aware of or receives any information, including follow-up regarding an AE/ADR or Other Information Reportable to Other Party associated with the use of the
Product manufactured by ARMSTRONG for WYETH, ARMSTRONG shall promptly provide WYETH with the source information within five (5) calendar days of
the date received by ARMSTRONG. If there is any doubt whether the AE/ADR came from Product manufactured by ARMSTRONG for WYETH, ARMSTRONG shall treat the AE/ADR as such and forward the AE/ADR to
WYETH. 

AE/ADR
information and Other Information Reportable to Other Party received by ARMSTRONG shall be transmitted by: 

	(a)
	Facsimile:
610-989-5544 or

	(b)
	Overnight
courier to: 

Global
Safety Surveillance & Epidemiology

Wyeth Research

GSSE Triage Unit

Dock E

60

 

500
Arcola Road

Collegeville, PA 19426 

For
purposes of case reconciliation, the Parties shall send a list of all AE/ADR information regarding the Product with local tracking numbers transmitted over the previous month to other Party.
Reconciliation of the prior month shall be completed by the end of the following month. If discrepancies are noted, either by reconciliation or other means, the responsible individuals at ARMSTRONG
and WYETH shall handle the matter on a case-by-case basis until satisfactory resolution. 

Periodic Report.    The Parties, in accordance with the CFR, shall produce the US PR for their respective Product. 

Health Authority or Ad Hoc Queries.    The Parties shall be responsible for responding to all safety queries from regulatory health
authorities (or agencies acting on the health authorities' behalf) as well as any ad hoc request for a safety query,directed to that Party's Product. The Parties agrees to provide the other Party with
any data relevant to a specific query. This information shall be provided as soon as reasonable given the context of the response deadline imposed by the regulatory authority or, if not explicitly
stated, the expectations for the response deadline interpreted by the Party who received the request. Each Party agrees to copy the other Party on their respective response. 

Signal Detection.    Each Party shall promptly review all information concerning safety of the Product that it has obtained from any source,
foreign or domestic, including data derived from clinical trials, epidemiologic studies, and commercial marketing experience reports as part of the scientific literature and from unpublished
scientific papers. Of the said information concerning the safety of the Product, if
a detected signal has impact on the established safety profile of the Product and new significant risk factors are identified, each Party shall expeditiously communicate the information to the other
Party and prior to any specific safety measures. 

Specific Safety Measures.    The Parties shall advise each other of any actions, relating to safety of the Product, that were taken by either
the ANDA Holder, Distributor or by regulatory health authority (eg, restriction in distribution) as soon as possible but in no event later than one (1) business day. If a specific safety action
is needed, WYETH and ARMSTRONG shall coordinate to address any action taken. 

The
Parties agree to meet after the effective date to establish a detailed Safety Agreement outlining the responsibilities of each Party in connection with collecting and reporting adverse events as
well as Literature Reports, Follow-up Reports, Reconciliation, US Periodic Reports, Periodic Safety Update Reports, Product Labeling Activities, and Pharmacovigilance related to the
Products which will supersede this Exhibit I. 

61

   EXHIBIT J  

Price Per Unit For Manufacture Under WYETH's NDA  

	Unit Volumes per Contract Year
 
	 	15ml Complete
	 	15ml Refill
	 	22.5ml Refill

	Less than [***]	 	[***]	 	[***]	 	[***]
	

[***] to [***] units	
 	

[***]	
 	

[***]	
 	

[***]
	

Greater than [***] units up to [***] units	
 	

[***]	
 	

[***]	
 	

[***]
	

Greater than [***] units	
 	

[***]	
 	

[***]	
 	

[***]

	*
	If
Wyeth elects to proceed with Option A, Armstrong will provide the costing detail (in a similar format to exhibit K) within 30 days to support the above pricing. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

62

   EXHIBIT K  

Price Per Unit For Manufacture Under ARMSTRONG's ANDA  

	Unit Volumes per Contract Year
 
	 	15ml Complete
	 	15ml Refill
	 	22.5ml Refill

	Less than [***] units	 	[***]	 	[***]	 	[***]
	

[***] units or greater	
 	

[***]	
 	

[***]	
 	

[***]

        Cost breakout attached. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

63

 

Product Cost Model (15 MI Complete)  

	Contract Manufacturer:	 	Armstrong Pharmaceuticals, Inc.	 	SKU No.:	 	 	 	 	 	 	 
	Site:	 	423 LaGrange St. W. Roxbury MA, 02132	 	Product Description:	 	Epinephrine Mist	 	 	 	 	 	 	 
	

	Effective Date	 	[***]	 	Pricing	 	 	 	 	Yield	 	 	 	[***]
	

	
Raw Material	
 	

Item #	
 	

Supplier, Site	
 	
 	

cost/kg	
 	

kg/batch	
 	

[***]	
 	
 	

cost/unit	
 	

Manufacturing & Packaging	
 	

 
	

	

Epinephrine	
 	

 	
 	

[***]	
 	
$	

[***]	
 	

[***]	
 	

 	
 	
$	

[***]	
 	

 	
 	

 
	CFC 12	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Hours/shift	 	 
	CFC 114	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Labor	 	 
	Ascorbic Acid	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Overhead $/shift	 	 
	Ethanol	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Output/shift	 	 
	Hydrochloric Acid	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	$ per Labor Hour	 	 
	Nitric Acid	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	 	 	 
	Water	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Cost per unit	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	RM Cost per unit	 	$	[***]	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 	 	 	Cost per unit	 	 
	 	 	 	 	 	 	 	 	 	 	 	Units/sku	 	 	 	 	Secondary Packaging	 	 
	 	 	 	 	 	 	 	 	 	 	 	Total RM Cost per SKU	 	 	 	 	(if not included above)	 	 
	

	Packaging Materials	 	Item #	 	Supplier, Site	 	 	cost/unit	 	units	 	[***]	 	 	cost/unit	 	Hours/shift	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Labor	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	[***]	 	$	[***]	 	Overhead $/shift	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Output/shift	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	$ per Labor Hour	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	 	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Cost per unit (1)	 	[***]
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	 	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Testing	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Raw Materials	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Pkg Materials	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	In-Process	 	 
	 	 	 	 	 	 	 	 	 	 	 	Cost per sku	 	$	[***]	 	Finished Goods	 	 
	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 	 	 	 	 	 
	
Note:	
 	

 	
 	

 	
 	
 	

 	
 	

 	
 	
Total pkg Matl Cost per SKU	
 	
 	

 	
 	
Cost per unit	
 	

[***]
	[***]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Total Cost per unit	 	[***]
	

 	
 	

 	
 	

 	
 	
 	

 	
 	

 	
 	

 	
 	
 	

 	
 	
Mark Up	
 	

[***]
	

 	
 	

 	
 	

 	
 	
 	

 	
 	

 	
 	

 	
 	
 	

 	
 	
Selling Price to WCH	
 	

[***]

[***] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions. 

64

 

Product Cost Model (15 MI Refill)  

	Contract Manufacturer:	 	Armstrong Pharmaceuticals, Inc.	 	SKU No.:	 	 	 	 	 	 	 
	Site:	 	423 LaGrange St. W. Roxbury MA, 02132	 	Product Description:	 	Epinephrine Mist	 	 	 	 	 	 	 
	

	Effective Date	 	[***]	 	Pricing	 	 	 	 	Yield	 	 	 	[***]
	

	
Raw Material	
 	

Item #	
 	

Supplier, Site	
 	
 	

cost/kg	
 	

kg/batch	
 	

[***]	
 	
 	

cost/unit	
 	

Manufacturing & Packaging	
 	

 
	

	

Epinephrine	
 	

 	
 	

[***]	
 	
$	

[***]	
 	

[***]	
 	

 	
 	
$	

[***]	
 	

 	
 	

 
	CFC 12	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Hours/shift	 	 
	CFC 114	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Labor	 	 
	Ascorbic Acid	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Overhead $/shift	 	 
	Ethanol	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Output/shift	 	 
	Hydrochloric Acid	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	$ per Labor Hour	 	 
	Nitric Acid	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	 	 	 
	Water	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Cost per unit	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	RM Cost per unit	 	$	[***]	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 	 	 	Cost per unit	 	 
	 	 	 	 	 	 	 	 	 	 	 	Units/sku	 	 	 	 	Secondary Packaging	 	 
	 	 	 	 	 	 	 	 	 	 	 	Total RM Cost per SKU	 	 	 	 	(if not included above)	 	 
	

	Packaging Materials	 	Item #	 	Supplier, Site	 	 	cost/unit	 	units	 	[***]	 	 	cost/unit	 	Hours/shift	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Labor	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	[***]	 	$	[***]	 	Overhead $/shift	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Output/shift	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	$ per Labor Hour	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	 	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Cost per unit (1)	 	[***]
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	 	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Testing	 	 
	[***]	 	 	 	[***]	 	$	[***]	 	[***]	 	 	 	$	[***]	 	Raw Materials	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Pkg Materials	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	In-Process	 	 
	 	 	 	 	 	 	 	 	 	 	 	Cost per sku	 	$	[***]	 	Finished Goods	 	 
	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 	 	 	 	 	 
	
Note:	
 	

 	
 	

 	
 	
 	

 	
 	

 	
 	
Total pkg Matl Cost per SKU	
 	
 	

 	
 	
Cost per unit	
 	

[***]
	[***]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Total Cost per unit	 	[***]
	

 	
 	

 	
 	

 	
 	
 	

 	
 	

 	
 	

 	
 	
 	

 	
 	
Mark Up	
 	

[***]
	

 	
 	

 	
 	

 	
 	
 	

 	
 	

 	
 	

 	
 	
 	

 	
 	
Selling Price to WCH	
 	

[***]

[***] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions. 

65

   EXHIBIT L  

NON-DISCLOSURE AGREEMENT  

66

 

[LOGO of Wyeth]  

        December 10,
2003 

Armstrong
Pharmaceuticals, Inc.

423 LaGrange Street

West Roxbury, Massachusetts 02132 

Re:
Confidentiality Agreement

Ladies
and Gentlemen: 

In
the course of discussions between Wyeth, acting through its Wyeth Consumer Healthcare Division (hereinafter referred to as "WCH") and Armstrong Pharmaceuticals, Inc. (hereinafter referred to
as "Armstrong") relating to the possible manufacture of Primatene Mist, the possible development of a new formulation for Primatene Mist and Dristan Mist, WCH may disclose to Armstrong certain
information, materials and/or data related to these products and WCH's marketing plans and/or business generally (hereinafter referred to as "WCH Information") and Armstrong may disclose to WCH
information relating to its manufacturing process (hereinafter referred to as "Armstrong Information"). 

        The
term "Information" shall refer to WCH Information, Armstrong Information, or both, as the context shall dictate, Each party represents that it has the right to disclose its
Information to the other. It is acknowledged that WCH Information and/or Armstrong Information may be disclosed not only in writing or other tangible form but also through discussions between our
respective representatives, demonstrations, observations and other intangible methods. 

        WCH
is prepared to disclose WCH Information to Armstrong and to accept the disclosure of Armstrong Information, and Armstrong is prepared to disclose Armstrong Information to WCH and to
accept the disclosure of WCH Information, on the following terms and conditions: 

        1.     Each
receiving party agrees, during the term of this Agreement and for the period ending five (5) years thereafter, not to disclose to any third party, or to use
other than for the purpose hereinabove set forth, any of the disclosing party's Information; provided that these restrictions on disclosure and use
shall not apply to any Information which: 

	(a)
	at,
prior or subsequent to the time of such disclosure is independently known to the receiving party without obligation of secrecy to a third party;

	(b)
	at,
prior or subsequent to the time of disclosure, becomes part of the public knowledge through no breach hereof by the receiving party;

	(c)
	subsequent
to the time of such disclosure is the subject of another agreement between the parties hereto which permits use and/or disclosure; or

	(d)
	is
required by law or judicial process to be disclosed 

        2.     Each
party represents that the foregoing obligations and commitments on its part shall be binding upon each of its individual employees who shall have access to any of
the Information of the other party and that, unless it has done so already, each party shall do all things necessary in order to bind each such employee in writing. Each party shall, within its
organization, limit access to such Information on a "need-to-know" basis. 

        3.     Upon
the written request of the disclosing party, the receiving party shall return all the Information of the disclosing party, or destroy such Information at the option
of the disclosing party; provided that one (1) copy of such Information may be retained by the receiving party, solely for the purpose of
monitoring its ongoing obligations hereunder. 

67

 

        4.     Nothing
herein shall be considered as granting to either party hereto by implication, estoppel or otherwise, any right, title or interest in, or any license, immunity or
other right under, any patent, or any of the Information of the other party, or as requiring either party to enter into any further agreements relating to this matter. 

        5.     The
term of this Agreement shall expire one (1) year from the above date, unless extended by mutual written agreement, but the obligations imposed hereunder in
Paragraphs 1, 3 and 4 shall survive such expiration. 

        6.     This
Agreement constitutes the entire agreement of the parties with respect to the subject matter hereof and shall not be amended orally, but only by an agreement in
writing, signed by both parties that states that it is an amendment to this Agreement. 

        7.     Any
notice expressly provided for under this Agreement shall be in writing, shall be given either manually or by mail, and shall be deemed sufficiently given if and when
received by the party to be notified at its address first set forth above, or if and when mailed by certified or registered mail, postage prepaid, addressed to such party at such address. Either party
may, by notice in writing to the other, change its address for receiving such notices. 

        8.     This
Agreement shall be construed in accordance with and governed by the law of the State of New Jersey, without giving effect to any conflict of laws provisions. 

        If
the foregoing is acceptable to you, please so indicate by signing and returning to WCH this Agreement which is being presented to you in duplicate. In due course, WCH will return a
fully executed copy hereof to Armstrong binding upon both parties effective as of the date first hereinabove written. 

	 	 	Very truly yours,
	 	 	 	 
	 	 	WYETH, acting through its

Wyeth Consumer Healthcare Division
	 	 	 	 
	 	 	By:	/s/  ME MOLLOY      
 Name: Me Molloy

Title: Vice President

	ACKNOWLEDGED, ACCEPTED

AND AGREED TO:	 	 
	 	 	 	 
	ARMSTRONG PHARMACEUTICALS, INC.	 	 
	 	 	 	 
	By:	/s/  DAVID W. NASSIF      
 Name: David W. Nassif

Title: CFO	 	 

68

   EXHIBIT M  

21 CFR 2.125  

        Pursuant to 21 CFR 2.125(g), FDA may, on its own initiative or in response to a petition filed by any person requesting them to do so, initiate
notice-and-comment rulemaking to remove an essential use of a metered-dose inhaler product containing epinephrine. To remove an essential use from the list,
compelling evidence of any one of the following criteria must be submitted: 

	1.
	The
product is no longer being marketed or

	2.
	After
January 1, 2005, FDA determines after consultation with an advisory committee and after an open public meeting that the product using an ODS no longer meets  all the following criteria:

	a.
	Substantial
technical barriers exist to formulating the product without ODSs;

	b.
	The
product provides an unavailable important public health benefit; and

	c.
	Use
of the product does not release cumulatively significant amounts of ODSs into the atmosphere or the release is warranted in view of the unavailable important public health benefit  or

	3.
	For
an active moiety marketed as an ODS product with one NDA, at least one equivalent non-ODS product with the same active moiety is being marketed, supplies of the
non-ODS product are sufficient to meet patient need, adequate U.S. postmarketing use data are available for the non-ODS product, and patients who medically required the ODS
product are adequately served by the equivalent non-ODS product and other available products or

	4.
	For
an active moiety marketed as an ODS product with two or more NDAs, at least two equivalent non-ODS products with the same active moiety are being marketed, supplies of
the non-ODS products are sufficient to meet patient need, adequate U.S. postmarketing use data are available for the non-ODS products, and patients who medically required the
ODS product are adequately served by the equivalent non-ODS products and other available products.) 

69

QuickLinks

Exhibit 10.26

TABLE OF CONTENTSQuickLinks
 -- Click here to rapidly navigate through this document

EXECUTION COPY  

  
 

    Exhibit 10.28    
    

 
 

DISTRIBUTION AGREEMENT    
    

        DISTRIBUTION AGREEMENT, dated as of May 2, 2005, by and between Amphastar Pharmaceuticals, Inc., a Delaware corporation ("Seller") and Andrx
Pharmaceuticals, Inc., a Florida corporation ("Purchaser"). 

        WHEREAS,
Seller desires to appoint Purchaser as Seller's exclusive distributor of the Product to Purchaser Customers in the Territory and Purchaser desires to accept such appointment,
all pursuant to the terms of this Agreement. 

        NOW,
THEREFORE, in consideration of the mutual promises, covesnants and agreements hereinafter set forth, the parties hereto agree as follows: 

ARTICLE 1  

 DEFINITIONS  

        As used throughout this Agreement and any exhibits, schedules and attachments hereto, each of the following terms shall have the respective meaning set forth
below: 

        1.1    "Act" means the Federal Food, Drug, and Cosmetic Act, as amended. 

        1.2    "Adverse Event" means any adverse event associated with the use of the Product in humans, whether or not considered
drug-related, including an adverse event occurring in the course of the use of the Product in professional practice, in studies, in investigations or in tests or an adverse event occurring
from Product overdose (whether accidental or intentional), from Product abuse, or from Product withdrawal, as well as any toxicity, sensitivity, failure of expected pharmacological action, or
laboratory abnormality that is, or is thought by the reporter thereof to be, serious or associated with relevant clinical signs or symptoms. 

        1.3    "Adverse Resolution" means any resolution of the Lawsuit, whether by settlement, summary judgment or trial court decision
in the U.S. District Court, or as a result of any appeal, subsequent review or reconsideration of such summary judgment or trial court decision, that prevents, enjoins, materially restricts or imposes
royalties on sales of or otherwise makes commercially unreasonable the manufacture, use, sale or offer to sell of the Product to Purchaser Customers in the Territory. 

        1.4    "Affiliate" of a party means any Person directly or indirectly controlled by, controlling or under common control with
such party. "Control" means the legal power to direct or cause the direction of the general management or policies of a Person through more than fifty percent (50%) of the ownership of voting
securities, by contract or by other means. 

        1.5    "ANDA" means an Abbreviated New Drug Application filed with the FDA and any amendments or supplements thereto. 

        1.6    "Anda" shall have the meaning given in Section 2.2. 

        1.7    "Applicable Laws" means all applicable laws, rules, and regulations that apply to the development, manufacture, supply,
marketing, sale or distribution of the Product in the Territory, or the performance of either party's obligations under this Agreement, including the Act, cGMP and other current regulations
promulgated by the FDA or any other governmental agency. 

        1.8    "At-Risk Launch" shall have the meaning given in Section 2.3. 

        1.9    "At-Risk Launch Notice" shall have the meaning given in Section 2.3. 

Confidential
treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as
[***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

        1.10    "Authorized Generic Product" means a therapeutically equivalent, bioequivalent and legally substitutable generic version
of the brand-name product Lovenox® (including the brand name product sold as a generic) that is sold and distributed in the Territory by any one or more of Aventis Pharma S.A.,
Aventis Pharmaceuticals, Inc., their respective Affiliates, successors or assigns and/or licensees of any of the foregoing. 

        1.11    "Bankruptcy Code" shall have the meaning given in Section 8.2. 

        1.12    "cGMP" means the current Good Manufacturing Practices regulations of the FDA (as in effect from time to time) in 21
C.F.R. pts. 210 and 211. 

        1.13    "Commercially Reasonable Efforts" means, with respect to each party, efforts and resources normally used by such party
to, in the case of Seller, develop, manufacture, package and supply or, in the case of Purchaser, market, sell and distribute, a generic pharmaceutical product owned by it or to which it has rights,
which is of similar overall market potential at a similar stage in its product lifecycle, taking into account, inter alia, the competitiveness of the marketplace, the proprietary position of the
product, the profitability of the product and other relevant factors. The parties acknowledge that the level of effort and resources may change at different times during the product life cycle of the
Product. 

        1.14    "Compensatory Payments" shall have the meaning given in Section 2.3. 

        1.15    "Competitive Product" means, other than the Product or an Authorized Generic Product, a therapeutically equivalent,
bioequivalent and legally substitutable generic version of the brand-name product Lovenox®, which generic version is in the same dosage and delivery form, has the same active
ingredient and the same strength and is for the same indication as the Product, that is sold and distributed in commercial quantities in the Territory by any Person, other than Purchaser or its
Affiliates, licensees or assigns. 

        1.16    "Confidential Information" shall have the meaning given in Article 14. 

        1.17    "Damages" shall have the meaning given in Section 17.1. 

        1.18    "Effective Date" means the date of this Agreement. 

        1.19    "Favorable Resolution" means a resolution of the Lawsuit, whether by settlement, summary judgment, trial court decision
in the U.S. District Court, or otherwise, that does not prevent, enjoin, materially restrict or impose royalties on sales of or otherwise make commercially unreasonable the manufacture, use, sale or
offer to sell of the Product to Purchaser Customers in the Territory, in each case irrespective of any rights of appeal, subsequent review or reconsideration of the resolution or of the outcome of
such appeal, review or reconsideration. 

        1.20    "FDA" means the U.S. Food and Drug Administration, and any successor or replacement agency thereto. 

        1.21    "Final Favorable Resolution" means a Favorable Resolution that is not subject to any rights of appeal, subsequent review
or reconsideration by the applicable governmental authority having competent jurisdiction over the Lawsuit. 

        1.22    "First Commercial Sale" means, as the context requires, the first date on which Purchaser sells (i.e., the date of
shipment) the Product in commercial quantities to a third party, or the first date on which Seller sells (i.e., the date of shipment) the Product in commercial quantities to a third party pursuant to
a Seller Launch. 

        1.23    "Forecast" shall have the meaning given in Section 5.2. 

        1.24    "Force Majeure Event" shall have the meaning given in Article 12. 

        1.25    "GAAP" means U.S. generally accepted accounting principles. 

        1.26    "Gross Profit" means Net Sales of Purchaser from sales of Product during a calendar quarter less the aggregate Transfer
Price paid for such Product. In the event for any calendar quarter the above calculation results in a negative number, "Gross Profit" shall be deemed zero for such calendar quarter. 

2

 

        1.27    "Gross Profit Split" shall have the meaning given in Section 4.2. 

        1.28    "Initial Purchase Order" shall have the meaning given in Section 5.1. 

        1.29    "Label", "Labeled" or "Labeling" means all labels and other written, printed or graphic matter upon (i) any
packaging, container or wrapper used with the Product, or (ii) any written material accompanying the Product, including package inserts; or, as the context requires, the act of applying and/or
using the same. 

        1.30    "Labor Costs" shall have the meaning given in Section 4.1 

        1.31    "Lawsuit" means (i) the lawsuit captioned Aventis Pharma S.A. and Aventis Pharmaceuticals, Inc. v.
Amphastar Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. under Case No. 03-CV-887 RT (SGLx) in the U.S. District Court in the Central District of
California Eastern Division and (ii) any related or subsequent U.S. trial court action pertaining to the same subject matter as the lawsuit described in clause (i) above, brought by
Aventis Pharma S.A. and Aventis Pharmaceuticals, Inc. against Seller prior to Seller delivering a Launch Notice, seeking to obtain a Adverse Resolution. 

        1.32    "Launch Notice" shall have the meaning given in Section 2.3. 

        1.33    "Launch Quantities" shall have the meaning given in Section 5.1. 

        1.34    "Maximum Compensatory Payments" shall have the meaning given in Section 2.3. 

        1.35    "Maximum Annual Product Units" shall have the meaning given in Section 5.6. 

        1.36    "Minimum Annual Product Units" shall have the meaning given in Section 8.4. 

        1.37    "Net Sales" means, with respect to the Product, the gross revenues derived from the sale of the Product by Purchaser or,
with respect to the determination of the Compensatory Payments, by Seller, and their respective Affiliates, licensees and assignees to independent third parties, minus normal and customary
(i) early pay incentives (i.e., cash discounts), (ii) trade discounts, quantity discounts, trade rebates, chargebacks, governmental rebates, such as Medicaid, retroactive price
adjustments (i.e., shelf stock adjustments) and cash incentive payments, (i.e., slotting allowances), (iii) Product returns, (iv) freight (inbound and outbound), (v) marketing
allowances, (vi) bad debt allowance which shall be deemed to be [***] of Net Sales for the first twelve months after First Commercial Sale and
[***] of Net Sales for periods thereafter and (vii) other normal and customary deductions utilized to calculate net sales, in each case to the extent applicable to the
sale of such Product. Marketing allowances shall (i) in the case of sales by Purchaser, be the actual marketing expenses but not in excess of [***] of the applicable Net
Sales and (ii) in the case of sales by Anda, be deemed to be [***] of the applicable Anda Net Sales of Product. The elements of Net Sales as described above shall be
determined in accordance with GAAP, applied on a basis consistent with the annual audited financial statements of Purchaser's parent corporation or Seller, as the context requires. 

        1.38    "Non-At-Risk Launch" shall have the meaning given in Section 2.3. 

        1.39    "Overdue Interest Amount" means the prime rate of interest quoted as such in The Wall Street Journal on the first
business day of each month during which an amount is overdue under this Agreement, plus 5%, calculated on an annual basis, not to exceed the maximum rate permitted by Applicable Law. 

        1.40    "Packaging" means all primary and/or bulk (as applicable) containers, Labels, shipping cases or any other like matter
used in packaging or accompanying the Product; or as the context requires, the act of applying and/or using the same. 

        1.41    "Person" means an individual, corporation, partnership, limited liability company or other entity. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

3

 

        1.42    "Product" means Seller's generic version of the enoxaparin sodium injectable product, in 30 mg, 40 mg, 60 mg, 80 mg, 100
mg, 120 mg, and/or 150 mg strengths, to the extent approved under ANDA 76-684, that is therapeutically equivalent and bioequivalent to, and legally substitutable for, the
brand-name product Lovenox®. 

        1.43    "Product Liability Claims" means any claim, action or proceeding based on personal injury, death or other similar
adverse effect to humans caused by (or alleged to be caused by) use of the Product. 

        1.44    "Product Warranty" shall have the meaning given in Section 16.1. 

        1.45    "Purchase Orders" shall have the meaning given in Section 5.3. 

        1.46    "Purchaser Customers" means, in each case to the extent located in the Territory, (a) chain retail pharmacies and
stores, (b) independent retail pharmacies, (c) grocery and food stores, (d) mail order pharmacies, (e) certain other types of customers not included within items (a)-(d)
that are pre-approved in writing by Seller pursuant to an amendment to this Agreement, and (f) drug wholesalers (solely to the extent allocated for resale to customers included in
items (a)-(e) above). Notwithstanding anything herein to the contrary, Seller expressly retains all rights to all current and future customers and markets for the Product, other than the customers
expressly included in items (a)-(f) above; and, without limiting the foregoing and by way of clarification, Seller's retained rights shall expressly include
the right to sell Product to drug wholesalers so long as Seller does not supply, sell or distribute Product to drug wholesalers for resale to any customer included in items (a)-(e) above. 

        1.47    "Purchaser Recall" shall have the meaning given in Section 11.3.2. 

        1.48    "Purchaser Trademarks" shall have the meaning given in Section 6.3. 

        1.49    "Raw Material Costs" shall have the meaning given in Section 4.1. 

        1.50    "Seller Launch" shall have the meaning given in Section 2.3. 

        1.51    "Specifications" means the specifications for the composition, manufacture, Packaging and/or quality control of the
Product as described in the ANDA for the Product, as the same may be supplemented from time to time as expressly provided in this Agreement. 

        1.52    "Territory" means the United States of America and its territories, including the Commonwealth of Puerto Rico. 

        1.53    "Third Party Infringement Claim" shall have the meaning given in Section 17.4. 

        1.54    "Transfer Price" shall have the meaning given in Section 4.1. 

        1.55    "Unit Price" shall have the meaning given in Section 4.1. 

ARTICLE 2  

 APPOINTMENT; SUPPLY AND PURCHASE OF PRODUCT  

        2.1    Appointment; Agreement to Supply; Development.

        2.1.1    Subject to the terms and conditions of this Agreement, Seller hereby appoints Purchaser as its exclusive distributor of
the Product for sale and distribution to Purchaser Customers in the Territory, and Purchaser hereby accepts such appointment. Subject to the terms of this Agreement, Seller shall use its Commercially
Reasonable Efforts to manufacture and supply to Purchaser its requirements of the Product for sale and distribution to Purchaser Customers in the Territory in accordance with Purchaser's Purchase
Orders as provided herein. Seller shall not, and shall cause its Affiliates not to, manufacture or supply the Product to Purchaser Customers in the Territory. Notwithstanding anything herein to the
contrary, the parties acknowledge and agree that Seller retains all rights to develop, manufacture, supply, sell, distribute, market, promote and otherwise commercialize, directly or through Seller's
Affiliates or third parties, Product to customers other than Purchaser Customers in the Territory; and without limiting the foregoing and by way of clarification, Seller's retained rights shall
expressly include the right to sell Product to drug wholesalers or any other Persons so long as Seller shall not supply, sell 

4

 

or
distribute Product to drug wholesalers or any other Person for resale to any customer included in items (a)-(e) of Section 1.46. 

        2.1.2    Seller hereby represents that it has filed with the FDA ANDA, File No. 76-684, for the Product.
Seller shall, at its expense, use Commercially Reasonable Efforts to prosecute the ANDA and to obtain approval from the FDA of the ANDA. Seller shall promptly upon its receipt of same deliver to
Purchaser written notice certifying that Seller has received final FDA approval of the Product's ANDA. The ANDA and all other regulatory approvals related to the manufacture and supply of the Product
shall be in Seller's name and owned exclusively by Seller. In addition, Seller shall, at its expense, use Commercially Reasonable Efforts to obtain a Favorable Resolution to enable FDA approval of the
Product's ANDA and the launch of the Product in the Territory. Notwithstanding the foregoing, nothing herein shall constitute a guarantee or warranty from Seller that the ANDA for the Product will be
approved by the FDA, or, if the Product ANDA is approved, any market exclusivity will be awarded, or any other regulatory approvals will be obtained by Seller or that a Favorable Resolution will be
obtained. Nothing herein shall limit Purchaser's right to terminate this Agreement pursuant to its terms. 

        2.2    Agreement to Purchase.

        2.2.1    Subject to the terms of this Agreement, Purchaser shall purchase exclusively from Seller all of Purchaser's
requirements for the Product for marketing, sale and distribution to Purchaser Customers in the Territory. Purchaser shall use Commercially Reasonable Efforts to market, sell and distribute the
Product throughout the Territory to Purchaser Customers. Subject to the foregoing, Purchaser does not make any guaranty or warranty as to any minimum level of Gross Profits or Net Sales. Nothing
herein shall limit each party's right to terminate this Agreement pursuant to its terms, including Section 8.4. Unless otherwise consented to in writing by Seller, Purchaser shall not offer the
Product as a loss leader, whether alone or in connection with any other product or sell the Product in combination or otherwise bundle the Product with other products in any fashion which decreases
the revenue that would otherwise be attributable to the Product had it not been sold as a loss leader or in combination or otherwise bundled. Subject to the foregoing and Purchaser performing its
obligations hereunder (including its obligation to use Commercially Reasonably Efforts to sell and distribute the Product), launch timing, pricing, marketing, sale and distribution and related
strategy for the Product for sale and distribution to Purchaser Customers in the Territory shall be the sole responsibility of, and shall be solely controlled by, Purchaser. 

        2.2.2    Purchaser shall, and shall cause its Affiliates to, sell and distribute the Product only to Purchaser Customers in the
Territory and only in accordance with Applicable Law and the Product's ANDA. Purchaser
shall reasonably cooperate with Seller in investigating and tracing any sales of the Product outside of the Territory or to any Persons in the Territory other than Purchaser Customers originating from
sales by Purchaser hereunder. Seller shall not, and shall cause its Affiliates not to, sell and distribute the Product to Purchaser Customers in the Territory (provided that, by way of clarification,
Seller may sell Product to drug wholesalers or any other Persons so long as Seller shall not supply, sell or distribute Product to drug wholesalers or any other Persons for resale to any customer
included in items (a)-(e) of Section 1.46). Seller shall reasonably cooperate with Purchaser in investigating and tracing any sales of the Product to any Purchaser Customers originating from
sales by Seller hereunder. 

        2.2.3    During the term of this Agreement and, if this Agreement is terminated by Purchaser pursuant to Section 8.4, for
a period of 12 months after such termination, neither Purchaser nor its Affiliates shall sell or distribute in the Territory any product that is or purports to be a generic equivalent (i.e.
bioquivalent and legally substitutable) of the Lovenox® brand product, other than the Product supplied by Seller hereunder. [***] 

        2.3    Commercial Launch of the Product. 

        2.3.1    Notice of Launch.    At any time after Seller receives both
(i) a Favorable Resolution (which may, but is not required to be, a Final Favorable Resolution) and (ii) FDA approval of the Product's ANDA and confirmation from the FDA that Seller has
been awarded 180 days of "first to file" market exclusivity in accordance with Section 505(j)(5)(B)(iv) of the Act, Seller shall be entitled to deliver to Purchaser a written
notice setting forth Seller's intention to commence the commercial sale of the 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

5

 

Product
in the Territory. Such written notice shall be referred to herein as an "At-Risk Launch Notice," unless based on a Final Favorable Resolution, in which case such written notice
shall be referred to herein as a "Non-At-Risk Launch Notice." As used herein, a "Launch Notice" may refer generally to an At-Risk Launch Notice and/or a
Non-At-Risk Launch Notice. Notwithstanding the foregoing, in the event that Seller receives FDA approval of the Product's ANDA, but Seller is not awarded 180 days "first
to file" market exclusivity and/or has not received a Favorable Resolution, Seller, at its option, may notify Purchaser of Seller's desire to commence the commercial sale of the Product in the
Territory. In such event, Seller and Purchaser shall negotiate in good faith the terms and conditions of any Product launch to Purchaser Customers in the Territory; provided that, by way of
clarification, nothing herein shall prevent (i) Seller from selling and distributing such Product in the Territory so long as Seller does not sell or distribute such Product to Purchaser
Customers (provided that, by way of clarification, Seller may sell Product to drug wholesalers or any other Persons so long as Seller shall not supply, sell or distribute Product to drug wholesalers
or any other Persons for resale to any customer included in items (a)-(e) of Section 1.46) or (ii) Purchaser from terminating this Agreement pursuant to its terms. 

        2.3.2    At-Risk Launch.    In the event that Purchaser
receives an At-Risk Launch Notice, Purchaser shall notify Seller in writing within 10 days of Purchaser's receipt thereof whether or not Purchaser agrees to launch the commercial
sale of the Product to Purchaser Customers in the Territory as contemplated herein based on such At-Risk Launch Notice (an "At-Risk Launch"). In the event that Purchaser
notifies Seller that it has determined to engage in an At-Risk Launch, Purchaser shall proceed according to the provisions of Section 2.3.3 below. In the event that Purchaser
notifies Seller that it has determined to not engage in an At-Risk Launch, Seller shall have 10 days from receipt of Purchaser's notice to notify Purchaser in writing whether or not
Seller has determined to engage in an At-Risk Launch without Purchaser acting as Seller's distributor of the Product to the Purchaser Customers in the Territory (a "Seller Launch"). In the
event that Seller notifies Purchaser that it has determined to so engage in a Seller Launch, subject to Sections 2.3.4 and 2.3.5 below, this Agreement (including any rights of Purchaser to sell and
distribute the Product in the Territory) shall automatically and immediately terminate as of the date of such Seller's notice to Purchaser. In the event that Seller notifies Purchaser that it has
determined to not engage in a Seller Launch, this Agreement shall continue in full force and effect and Seller may at any time thereafter submit a new Launch Notice, at which time the parties shall,
among other things, again proceed in accordance with the provisions of this Section 2.3. 

        2.3.3    Obligation to Launch.    In the event that Seller delivers to
Purchaser a Non-At-Risk Launch Notice or Purchaser notifies Seller that Purchaser has determined to engage in an At-Risk Launch, Purchaser shall (i) pay the
milestone payment set forth in Section 3.1(b) below in accordance with the provisions thereof, and (ii) subject to the terms of this Agreement, Purchaser shall use Commercially
Reasonable Efforts to commence with Purchaser's First Commercial Sale as soon as commercially practicable thereafter, but in no event later than 5 business days following Purchaser's receipt of Launch
Quantities. 

        2.3.4    Payment of Compensatory Payments upon a Seller
Launch.    Subject to Section 2.3.5 below, in the event that Seller engages in a Seller Launch, Seller shall pay to Purchaser payments (the "Compensatory
Payments"), up to the aggregate amount of [***] (the "Maximum Compensatory Payments"), equal to: 

        (a)   during the first six full calendar months following Seller's First Commercial Sale pursuant to the Seller Launch, the
greater of (i) [***] of Seller's Net Sales of Product sold in the Territory and (ii) [***]; 

        (b)   during the second six full calendar months following Seller's First Commercial Sale pursuant to the Seller Launch, the
greater of (i) [***] of Seller's Net Sales for Product sold in the Territory and (ii) [***]; and 

        (c)   [***] of Seller's Net Sales of Product sold in the Territory during each calendar quarter after
the first twelve full calendar months after Seller's First Commercial Sale pursuant to the Seller Launch. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

6

 

        2.3.5    The Compensatory Payments shall be paid within 30 days of the end of each calendar quarter following Seller's
First Commercial Sale pursuant to the Seller Launch. Each Compensatory Payments payment shall include a report setting forth in reasonable detail the amount of and the basis for such payment,
including a calculation of Seller's Net Sales (including itemizing all deductions to gross sales) for such quarterly period. With respect to any payment due as a result of the
[***] minimum Compensatory Payments amounts set forth in Sections 2.3.4(a) and (b) above, such payment shall be made within 30 days of the end of the calendar
quarter that contains the sixth month of the applicable six month period for which the [***] minimum Compensatory Payments amount accrued. Any payments not made within the
specified period of time for payment shall incur an interest charge at the rate of the Overdue Interest Amount on such overdue amounts, excluding any amounts that are subject to a bona fide dispute
between the parties. 

        2.3.6    Subsequent Suspension of a Seller
Launch.    In the event that, within 30 days of Seller's First Commercial Sale pursuant to a Seller Launch, Seller either voluntarily or as a result of an
order of the FDA or any court having competent jurisdiction ceases to sell in and withdraws the Product from the market in the Territory, Seller's obligation to pay the Compensatory Payments pursuant
to such Seller Launch shall immediately terminate as of the date of such withdrawal and this Agreement shall be automatically and immediately reinstated and be in full force and effect on and after
the date of such withdrawal pursuant to its terms. Without limiting the generality of the preceding sentence, in the event that, at any time after such withdrawal of the Product, Seller determines to
engage in a new commercial launch of the Product in the Territory, Seller shall provide to Purchaser a Launch Notice pursuant to Section 2.3.1 above and the remaining provisions of this
Section 2.3 shall again apply to such new Launch Notice. In the event that Seller after such withdrawal of the Product delivers to Purchaser a Non-At-Risk Launch Notice
or Purchaser notifies Seller that it will engage in an At-Risk Launch in accordance with Section 2.3.2 above following receipt of an At-Risk Launch Notice, in addition
to the payment of the milestone payment under Section 3.1(b) required in connection therewith, Purchaser shall refund to Seller any amount of the Compensatory Payments previously paid to Seller
within 10 days of receipt by Purchaser of such Non-At-Risk Launch Notice or receipt by Seller of Purchaser's notice of intention to engage in an At-Risk
Launch. In the event that Purchaser determines to not engage in such subsequent At-Risk Launch and Seller commences a subsequent Seller Launch, (i) each of the
[***] minimum Compensatory Payments amounts under Sections 2.3.4(a) and (b) shall be reduced to an amount equal to [***] multiplied by a
fraction, the numerator of which is the number of months of Product sales under all previous Seller Launches pursuant to which Seller paid Compensatory Payments and the denominator of which is six and
(ii) the Maximum Compensatory Payments shall be reduced by the amount all Compensatory Payments previously paid to Purchaser. 

        2.4    Termination of Agreement Relating to Commercial Launch.

        2.4.1    In addition to Purchaser's termination rights set forth elsewhere herein, Purchaser shall be entitled to terminate this
Agreement as set forth in this Section 2.4.1: 

        (a)   Purchaser may terminate this Agreement after June 30, 2006, upon 30 days prior written notice to Seller, if
Seller shall not have obtained a Favorable Resolution on or prior to June 30, 2006, so long as such termination notice is received by Seller on or before July 15, 2006. 

        (b)   Provided that Purchaser shall not have notified Seller that it will engage in an At-Risk Launch prior
thereto, Purchaser may terminate this Agreement after June 30, 2006, upon 30 days prior written notice to Seller, if after June 30, 2006 an Adverse Resolution then exists, so long
as such termination notice is received by Seller within 15 days after the later of June 30, 2006 or the date Purchaser is notified of such Adverse Resolution. Seller shall provide
written notice to Purchaser within 10 days of any Adverse Resolution. For purposes of clarification, Purchaser's right to terminate this Agreement under this Section 2.4.1(b) shall not
apply after Seller's delivery to Purchaser of a Launch Notice, unless such Launch Notice is an At-Risk Launch Notice, and then only in the event that this Agreement remains in effect
pursuant to Seller's determination to not engage in a Seller Launch under Section 2.3.2 or this Agreement is reinstated following a Product withdrawal pursuant to Section 2.3.6. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

7

 

        (c)   Purchaser may terminate this Agreement after June 30, 2007, upon 30 days prior written notice to Seller, if
Seller shall not have delivered to Purchaser a Launch Notice on or before June 30, 2007, so long as such termination notice is received by Seller on or before July 15, 2007. 

        2.4.2    Notwithstanding anything herein to the contrary, Purchaser's sole remedy, whether in contract, tort or otherwise, for
any failure by Seller to use Commercially Reasonable Efforts to obtain ANDA approval of the Product or any market exclusivity with respect thereto and/or any additional regulatory approvals necessary
for the manufacture and supply of the Product and/or to obtain a Favorable Resolution shall be the termination of this Agreement as provided in this Section 2.4 and the right to any refund of
the milestone payment under Section 3.2. 

        2.4.3    This Agreement may be terminated by Seller upon 5 days written notice to Purchaser, if Purchaser shall have not
effected Purchaser's First Commercial Sale within 5 business days following Purchaser's receipt of Launch Quantities in accordance with Section 2.3.3. 

        2.5    Sales to Wholesalers. Subject to the terms and conditions of this Agreement, Purchaser shall have exclusive rights to
sell Product to drug wholesalers or any other Persons for resale and distribution to the customers in the Territory identified in items (a)-(e) of Section 1.46. Seller retains all rights to all
other current and future customers and markets for the Product, including the right to sell Product to drug wholesalers or any other Persons so long as Seller does not supply, sell or distribute
Product to drug wholesalers or any other Persons for resale to any customer included in items (a)-(e) of Section 1.46. As
permitted by Applicable Law, Purchaser and Seller shall cooperate in creating arrangements with their respective drug wholesalers and other customers necessary to implement the foregoing. From time to
time upon request, each party shall provide the other with reasonable access to all information in its possession and control (or which is reasonably obtainable) to confirm the ultimate customer of
the Products sold by it to drug wholesalers or other Persons. To the extent Seller sells any Products to drug wholesalers or other Persons that are ultimately purchased by any customer included in
items (a)-(e) of Section 1.46, Seller shall pay Purchaser its portion of the Gross Profits (i.e., Seller's Net Sales less the imputed Transfer Price of the Product times Purchaser's then
applicable portion of the Gross Profit Split) attributable to such sales by Seller plus the Overdue Interest Amount on the amount due from the date of the sale to the date of payment. To the extent
Purchaser sells any Product to drug wholesalers or other Persons that are ultimately purchased by any customer not included in items (a)-(e) of Section 1.46, then Purchaser shall pay to Seller
all of the Gross Profit attributable to such sales by Purchaser plus the Overdue Interest Amount on the amount due from the date of the sale to the date of payment. The above described Gross Profit
reimbursement shall be each party's exclusive remedy for any inadvertent and unintentional breach by the other party of its obligations under this Section 2.5. In addition, without limiting
either party's indemnification obligations under Article 17, if either party intentionally breaches this Section 2.5, the party in breach shall indemnify the other party pursuant to
Article 17 for all Damages caused thereby. 

        2.6    Information. Seller shall provide Purchaser with copies of all material study results and other written communications
that Seller submits to the FDA in connection with its attempt to obtain approval of the Product's ANDA or otherwise relating to the Product as soon as reasonably practicable after Seller's receipt or
submission thereof. At Purchaser's request from time to time during normal business hours and upon reasonable notice, Seller shall also provide Purchaser reasonable access to any other study results
and other written communications that Seller submits to the FDA in connection with its attempt to obtain approval of the Product's ANDA or otherwise relating to the Product in Seller's possession. In
addition, Seller shall provide Purchaser with copies of all material pleadings, motions, briefs and other written communications relating to the Lawsuit as soon as reasonably practicable after
Seller's receipt or submission thereof. At Purchaser's request from time to time during normal business hours and upon reasonable notice, Seller shall provide Purchaser with reasonable access to any
other pleadings, motions, briefs and other written communications relating to the Lawsuit in Seller's possession. The obligations of Seller provided above shall be subject to Applicable Law (including
compliance with any protective order or other court or governmental agency order or requirement), maintaining applicable privileges and the terms of any confidentiality obligations of Seller owned to
third parties. 

8

 

ARTICLE 3  

 MILESTONES AND PAYMENTS  

        3.1    Milestones and Payments. In consideration of Seller's grant of the exclusive distribution rights hereunder to Purchaser,
Purchaser shall pay Seller the following amounts upon completion of the applicable milestone: 

	Milestone:
 
	 	Amount of Payment Due:

	    (a)    The Effective Date of this Agreement	 	$	4,500,000
	

    (b)    Within 10 days of both (x) either (i) Purchaser's receipt of a Non-At-Risk Launch Notice under Section 2.3.1 above or (ii) Purchaser's written notice to Seller that Purchaser will engage in an
At-Risk Launch under Section 2.3.2 above and (y) delivery to Purchaser of the Launch Quantities.	
 	
$	

5,500,000
	

    TOTAL:	
 	
$	

10,000,000

        3.2    Payment Terms; Refund.

        3.2.1    Any payments not made within the specified period of time for payment shall incur an interest charge at the rate of the
Overdue Interest Amount on such overdue amounts, excluding any amounts that are subject to a bona fide dispute between the parties. All payments shall
be made in U.S. dollars through electronic transfer of funds or other wire transfers. 

        3.2.2    Except as expressly set forth in this Section 3.2.2, no milestone payment shall be refundable in whole or in
part under any circumstance, including a termination of this Agreement pursuant to Seller engaging in a Seller Launch under Section 2.3.2. The $4,500,000 milestone payment paid to Seller under
Section 3.1(a) above shall be refunded by Seller to Purchaser in the event this Agreement is terminated pursuant to Section 2.4.1 above; provided, however, in the event that this
Agreement is terminated pursuant to Section 2.4.1 at any time after Seller shall have paid Compensatory Payments to Purchaser, the amount of such Compensatory Payments shall be deducted from
such refund of the milestone payment and any amount of such Compensatory Payments in excess of the amount of the milestone payment shall be refunded to Seller within 30 days of such
termination. All such refunds shall be made by Seller within 30 days after the applicable termination date; provided that, such amount remaining outstanding shall bear simple interest at the
rate of the Overdue Interest Amount commencing on the date such amount is due and payable (i.e., 30 days after the applicable termination date) until paid in full; and provided further that, if
Seller does not have at the time the available funds to repay Purchaser such amount, such amount shall be repaid no later than one year from the applicable termination date. If payment is not made
within 30 days of termination, upon request of Purchaser, Seller shall (as soon as reasonably practicable) provide Purchaser with reasonable security for repayment of any milestone payments not
paid when due, including potentially, assignment of product revenues or a lien on other assets. 

9

 
ARTICLE 4  

 PRICING  

        4.1    Transfer Price.

        4.1.1    The transfer price ("Transfer Price") payable by Purchaser for Product delivered by Seller shall be a payment equal to
the product of (a) the number of units of Product delivered by Seller to Purchaser pursuant to the applicable Purchase Order (including the Initial Purchase Order), multiplied by (b) 
[***] unit, regardless of dosage strength (the "Unit Price"). Notwithstanding the foregoing, on and after the [***] of the First Commercial Sale, Seller
may increase the Unit Price during each twelve month period (which begins on an anniversary of the First Commercial Sale), effective upon 30 days prior written notice to Purchaser (or upon the
later resolution of any disputed price increase, except if such dispute is resolved in Seller's favor in which case the Unit Price increase shall be effective 30 days from Seller's original
notice thereof to Purchaser), by (i) the actual per unit increase in Seller's raw materials costs (the "Raw Material Costs") for the Product (including the costs of plunger rods, needle stick
prevention devices, syringes, Packaging and other ingredients and materials used to manufacture and process the Product) over the 12 month period preceding the date of Seller's notice of such
price increase not to exceed (subject to Section 4.1.2) [***] of the amount of Seller's Raw Material Costs as at the beginning of the 12-month period
immediately prior to such price increase and (ii) the actual per unit increase in Seller's direct labor costs ("Labor Costs") for the Product over the prior 12 month period preceding the
date of Seller's notice of such price increase not to exceed (subject to Section 4.1.2) [***] of the amount of the Seller's Labor Costs as at the beginning of the
12-month period immediately prior to such price increase. Seller shall provide Purchaser with reasonable documentation evidencing the applicable increases in Seller's Raw Material Costs
and Labor Costs with Seller's notice of the price increase. Purchaser may dispute in good faith any increase to the Unit Price pursuant to this Section 4.1.1 by written notice to Seller within
10 days of Purchaser's receipt of Seller's notice thereof. If the dispute is not resolved within 30 days of Purchaser's dispute notice to Seller, then Purchaser may elect to seek
resolution of the dispute pursuant to the provisions of Section 4.5 by providing written notice to Seller of such election. If Purchaser does not provide Seller such written notice within
10 days after the aforementioned 30 day period, then the dispute shall be deemed resolved in Seller's favor. 

        4.1.2    At the written request of Seller on and after the [***] of the First Commercial Sale, the
parties shall discuss increases in the Unit Price in excess of the respective [***] limitations provided in Section 4.1.1 to the extent such increases are due to
increases in Raw Material Costs and/or Labor Costs attributable to changes required by Applicable Law or governmental authority, including FDA, as provided in Section 6.2.1. Any such request
for an increase in the Unit Price in excess of the respective [***] limitations provided in Section 4.1.1 shall be reasonably considered in good faith by Purchaser but
shall not be implemented without Purchaser's written consent (which shall not be unreasonably withheld, delayed or conditioned). In the event Seller's Raw Material Costs and/or Labor Costs increase by
[***] or more during any twelve month period as a result of changes required by Applicable Law or governmental authority, including FDA, as provided in Section 6.2.1
(based on reasonable documentation) and Purchaser does not consent to a corresponding increase as requested by Seller in the Unit Price in excess of the respective [***]
limitations (as the case may be) provided in Section 4.1.1 within [***] of the date of Seller's written request for such increase, then Seller shall (by written notice
within [***] of the date of Seller's written
request for such increase) have the right to terminate this Agreement upon [***] written notice to Purchaser. 

        4.2    Gross Profit Split.

        4.2.1    Purchaser shall pay to Seller, as additional consideration for Seller's supply of Product hereunder to Purchaser, the
following portion of Gross Profit (the "Gross Profit Split"): 

        (a)   60% percent of the Gross Profit for so long as there are [***] Competitive Products; 

        (b)   55% percent of the Gross Profit for so long as there is (i) [***] Competitive Product
being sold and distributed to Purchaser Customers in the Territory or (ii) [***] Competitive Product being sold and distributed to customers in the Territory other than
Purchaser Customers and as a result of the sale and distribution of such Competitive Product, Purchaser's Net Sales for the last completed calendar quarter are more than [***]
less than Purchaser's Net Sales for the calendar quarter immediately preceding the last completed calendar quarter; and 

        (c)   50% percent of the Gross Profit for so long as there are (i) [***]or more Competitive
Products being sold and distributed to Purchaser Customers in the Territory or (ii) [***] or more Competitive Products being sold and distributed to customers in the
Territory other than Purchaser Customers and as a result of the sale and distribution of such Competitive Products, Purchaser's Net Sales for the last completed calendar quarter are more than
[***] less than Purchaser's Net Sales for the calendar quarter immediately preceding the last completed calendar quarter. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

10

 

        4.2.2    Seller's Gross Profit Split shall be calculated and paid to Seller quarterly, within 30 days after quarter end.
Any adjustment to the Gross Profit Split as required from time to time due to an increase or decrease in the number of Competitive Products or Purchaser's Net Sales shall be effective upon the day of
the calendar month in which the change of number of Competitive Product(s) occurred in the case of Section 4.2.1(b)(i) and (c)(i) above and upon the first day of the immediately
succeeding calendar month after the calendar month in which the change in Purchaser's Net Sales triggered an adjustment to the Gross Profit Split in the case of Section 4.2.1(b)(ii) or
(c)(ii) above. Notwithstanding anything herein to the contrary and by
way of clarification, any adjustment to the Gross Profit Split resulting from a change in the number of Competitive Products or Net Sales shall change only the Gross Profit Split of Product having the
same dosage strength as that of the relevant Competitive Product(s) then being sold and distributed in the Territory. Each party shall provide the other party prompt written notice of any adjustment
to the Gross Profit Split which the notifying party believes is warranted as a result of a change in the number of Competitive Products or Purchaser's Net Sales. With such notice, the notifying party
shall provide an explanation to the other party as to the reasons why such adjustment is warranted and shall provide the other party any documentation in notifying party's possession or control which
supports the notifying party's basis for such adjustment. 

        4.3    Shipping Terms. The prices charged by Seller to Purchaser shall be FCA (Incoterms 2000), Seller's designated
manufacturing facility. 

        4.4    Payment Terms.

        4.4.1    The Transfer Price for the Product shall be paid within 30 days of the date of the applicable invoice for such
Product. 

        4.4.2    The Gross Profit Split shall be paid within 30 days of the end of each calendar quarter, with a report setting
forth in reasonable detail the amount of and the basis for such payment, including a calculation of Purchaser's Net Sales (including itemizing all deductions to gross sales), Gross Profit and the
Gross Profit Split (as applicable on a dosage strength basis) for such quarterly period [***]. 

        4.4.3    Any payments not made within the specified period of time for payment shall incur an interest charge at the rate of the
Overdue Interest Amount on such overdue amounts, excluding any amounts that are subject to a bona fide dispute between the parties. In addition, Seller
may withhold shipment of Product to Purchaser if Purchaser has failed to make any payment required under this Agreement (except for any amounts that are subject to a bona
fide dispute) after the due date for such payment. All payments shall be made in U.S. dollars through electronic transfer of funds or other wire transfers. 

        4.5    Audit Rights. Purchaser with respect to Section 2.2.3 and this Article 4 and Seller with respect to
Sections 2.3.4 and 4.1 shall keep complete and accurate books and records for purposes of documenting the amount and calculations of, as applicable, Net Sales [***], Gross
Profit, Gross Profit Split, the Compensatory Payments and, to the extent it is a basis for an increase in the Transfer Price pursuant to Section 4.1, increases in Raw Material Costs and Labor
Costs. Said books of account shall be kept at Purchaser's or Seller's principal place of business, as applicable. Upon reasonable notice, each Purchaser or Seller, as applicable, at its expense, shall
have the right to have an independent public accounting firm (reasonably acceptable to the other party) obtain access to the other party's financial records, during reasonable business hours, solely
for the purpose of verifying such party's payments hereunder; provided, however, that this right may not be exercised more than once in any calendar year (unless a prior audit by the audited party in
such calendar year reveals a discrepancy of the greater of 5% of the payment(s) audited or $25,000 in any calendar quarter and then the auditing party may exercise its audit right no more than twice
during such calendar year). The accountants engaged by the auditing party shall report to the auditing party only information of the audited party related to the accuracy of the audited party's
calculations then being audited. The findings of the accountants engaged by the auditing party shall be final and binding upon the parties hereto, and the payments attributable to any particular
period may only be audited once for such period. Any underpayment or overpayment of the amount due hereunder due to a miscalculation of such amount shall be paid within 30 days after the
delivery of a written accountants'
report to each party. In the event any such audit reveals a shortfall greater than 5% of the payment(s) audited or $25,000 in any calendar quarter, then the reasonable costs of the accountants engaged
by the auditing party to perform such audit shall be reimbursed by the audited party. Any underpayment or overpayment amount paid pursuant to this Section 4.5 shall accrue interest on such
amount from the original due date at the Overdue Interest Amount. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

11

 
ARTICLE 5  

 LAUNCH QUANTITIES, FORECASTS, ORDERS  

        5.1    Initial Purchase Order; Launch Quantities. Within 5 days following receipt of a
Non-At-Risk Launch Notice by Purchaser or delivery to Seller of Purchaser's notice that it will engage in an At-Risk Launch, Purchaser shall deliver to Seller an
initial binding order (the "Initial Purchase Order") for the quantity of Product required for Purchaser's commercial launch of the Product consistent with Purchaser's then current Forecast; provided
that, such quantity shall not exceed (without the prior written consent of Seller, which may be withheld in its sole discretion) [***] units of Product if the First Commercial
Sale occurs in calendar year 2005 or [***] of the then existing Maximum Annual Product Units if the First Commercial Sale occurs in any calendar year after 2005 (the "Launch
Quantities"). Subject to the terms of this Agreement, Seller shall use Commercially Reasonable Efforts to supply the Product to Purchaser in the Launch Quantities by no later than the delivery dates
indicated in the Initial Purchase Order, which delivery dates shall be no sooner than 90 days after the date of the Initial Purchase Order unless Seller consents thereto. Seller shall
thereafter use Commercially Reasonable Efforts to supply to Purchaser such additional quantities of the Product as ordered by Purchaser hereunder pursuant to Section 5.3. 

        5.2    Forecasts. Beginning at least 6 months prior to the anticipated date of FDA approval of the Product's ANDA and at
least 90 days prior to each calendar quarter thereafter, Purchaser shall provide to Seller a rolling 12-month forecast (each a "Forecast") of the quantities of the Product to be
purchased by Purchaser on a monthly basis. Without limiting the foregoing, in addition to the above Product quantities, each Forecast delivered by Purchaser prior to its First Commercial Sale shall
include the Launch Quantities. Forecasts shall be in good faith and non-binding, provided, however, that (a) on and after Purchaser's delivery of its Initial Purchase Order to
Seller, the first three months of each Forecast shall be binding on Purchaser, and shall constitute Purchaser's firm order for the quantity of Product set forth in such Forecast; and
(b) forecasted quantities of the Product for the fourth, fifth and sixth months forecasted
thereunder shall not increase by more than 25% from the quantities forecasted for such months in the preceding Forecast without Seller's prior written consent (not to be unreasonably withheld or
delayed). 

        5.3    Orders. Except for the Initial Purchaser Order, Purchaser shall deliver to Seller purchase orders ("Purchase Orders") for
the Product no later than 90 days before the date that the Products for such Purchase Order are required to be delivered to Purchaser and provided such Purchase Orders are for the binding
portion (i.e., the first three months) of the then current Forecast in accordance with Section 5.2, Seller shall accept such Purchase Orders. Subject to Section 5.6, Seller shall use
Commercially Reasonable Efforts to satisfy Purchase Orders for amounts in excess of those forecasted for the binding portion of the then current Forecast pursuant to Section 5.2; provided that
in no event shall Seller be required to add to its existing manufacturing capacity of its facility(ies) for the Product in order to satisfy Purchaser's Purchase Orders. Each such Purchase Order shall
be firm and shall specify the quantity of the Product ordered, the date on which such Product shall be delivered and the delivery address. Product shall be ordered by Purchaser in no less than full
batch increments. 

        5.4    Shipping Reports. On or promptly after the date of each shipment of Product, Seller shall submit to Purchaser, via
facsimile, a packing slip containing the ship date, trailer number, contents and quantities of each shipment and invoice for the Transfer Price. 

        5.5    Standard Forms; Conflicts. In ordering and delivering the Product pursuant hereto, Seller and Purchaser may use their
standard forms (including Purchase Orders, invoices, sales acknowledgments, etc.), but nothing in those forms shall be construed to modify, amend or supplement the terms of this Agreement and, in case
of any conflict herewith, the terms of this Agreement shall control, and any additional or modified terms contained in any such Purchase Order or other form shall be null and void and shall not be
binding upon the receiving party. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

12

 

        5.6    Capacity Allocation.

        5.6.1    Notwithstanding anything herein to the contrary or anything to the contrary in any Purchase Order or Forecast, Seller
shall not be obligated to supply Purchaser (regardless of amounts ordered by Purchaser), more than the then applicable Maximum Annual Product Units during a twelve month period. Without limiting the
foregoing, any Purchase Order or Forecast submitted by Purchaser hereunder for more than the then applicable Maximum Annual Product Units shall, to the extent of the excess, be deemed rejected by
Seller, unless expressly accepted by Seller in writing. As used herein, the term "Maximum Annual Product Units" shall mean for the period ending twelve full calendar months from the First Commercial
Sale and for each twelve month period thereafter, [***] of the total units of branded and
generic Lovenox® product (including the brand name product, the Product, any Authorized Generic Product and any Competitive Product) sold for distribution into the Territory for the
immediately preceding calendar year as reported by IMS Health (or such other nationally recognized data compilation source as mutually agreed); provided that, if the First Commercial Sale occurs
during calendar year 2005, then the Maximum Annual Product Units for the period ending twelve full calendar months from the First Commercial Sale shall be deemed to be [***] of
Product. For each twelve month period beginning after the First Commercial Sale (other than as provided above if the First Commercial Sale occurs in calendar year 2005), the Maximum Annual Product
Units shall be established as soon as data from IMS Health (or such other nationally recognized source as mutually agreed) for the immediately preceding calendar year becomes available to the parties
and once the Maximum Annual Product Units for the then current twelve month period is established, it shall be effective retroactively to the beginning of and shall be fixed through such twelve month
period. Without limiting the foregoing, but by way of example: If the First Commercial Sale occurs on September 1, 2005, then the Maximum Annual Product Units for the twelve month period ending
with August 31, 2006 would be [***] units of Product. As a result, Purchaser would have no right to order or purchase, and Seller would have no obligation to supply,
more than [***] units of Product during the twelve month period ending August 31, 2006. Assuming that [***] total units of branded and generic
Lovenox® product were sold for distribution into the Territory for the 2005 calendar year as reported by IMS Health, then the newly established Maximum Annual Product Units for the twelve
month period ending August 31, 2007 would be [***] units of Product (i.e., [***] units). As a result, Purchaser would have no right to order or
purchase, and Seller would have no obligation to supply, more than [***] units of Product during the twelve month period ending August 31, 2007. The foregoing process
would be repeated once each twelve month period thereafter to establish the Maximum Annual Product Units for the then current twelve month period. At Purchaser's request from time to time, the parties
shall discuss increasing the then existing Maximum Annual Product Units based on then existing market conditions, Seller's manufacturing capacity and other relevant factors. Seller shall reasonably
consider Purchaser's request and its reasons for an increase in the then existing Maximum Annual Product Units; provided that, Seller shall have no obligation to agree to (and may reject in Seller's
sole discretion and without liability) any increase requested by Purchaser in the then existing Maximum Annual Product Units. 

        5.6.2    In the event that Seller's inability (including any inability as a result of a Force Majeure Event) to satisfy any
Purchase Order accepted pursuant to Section 5.3, in whole or in part, is due to a shortage of production capacity or raw materials, then, subject to the terms and conditions of this Agreement,
including Section 5.6.1 above, Seller shall give priority to Purchaser's Purchase Orders, and satisfy deliveries of amounts ordered consistent with Section 5.3 prior to fulfilling order
for Product of any other Person, for up to (i) [***] units of Product to be delivered to Purchaser pursuant to its Purchase Orders for the period ending six full
calendar months after the First Commercial Sale and (ii) [***] units of Product to be delivered to Purchaser pursuant to its Purchase Orders during each six month period
thereafter and for any Product to be delivered to Purchaser pursuant to its Purchase Orders during such six month period in excess of the foregoing [***] unit amount,
[***] of Seller's units of its finished inventory of Product produced during the applicable period in excess of [***] units shall be allocated to
fulfill any such remaining outstanding Purchase Orders. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

13

   ARTICLE 6  

 SPECIFICATIONS  

        6.1    Specifications. The Specifications for the Product will be as described in the ANDA that is approved by FDA for the
Product. The Specifications for the Product shall not be changed except as expressly permitted under this Agreement. 

        6.2    Change Management.

        6.2.1    Required Changes.    With respect to any changes to the
Specifications or to any process involved in the manufacture, Packaging, Labeling, storage, transportation, delivery or testing of the Product that are required by Applicable Laws or by mandate of an
applicable government authority (including the FDA), the parties shall reasonably cooperate in making such changes promptly, and Seller shall, subject to Section 4.1 and unless otherwise
mutually agreed to in writing by the parties, bear the costs of implementing such changes, including the cost of scrapping materials (including raw materials, in-process materials,
inventory and packaging material) associated with such changes. 

        6.2.2    Discretionary Changes.    With respect to changes to the
Specifications or to any process involved in the manufacture, Packaging, Labeling, storage, transportation, delivery or testing of the Product that are not required by Applicable Laws or by mandate of
an applicable government authority (including the FDA), the parties shall cooperate in good faith to reach a mutually agreeable solution with regard to such changes, but Seller shall not be obligated
to make any such changes requested by Purchaser except as expressly provided in Section 6.2.3. Seller reserves the right to make such changes unilaterally;  provided, however, that Seller will
consult with Purchaser prior to making such changes; and provided further that, Seller shall obtain Purchaser's
prior written consent (which will not be unreasonably withheld or delayed) for any changes that would materially affect storage or transportation of the Product after delivery to Purchaser. The cost
of making a discretionary change shall be borne solely by the party initiating the change or as otherwise mutually agreed to in writing by the parties. In the event any such changes initiated by
Purchaser increase Seller's costs of manufacturing and supplying the Product to Purchaser, at Seller's request, the parties shall discuss and agree in good faith to an equitable adjustment of the Unit
Price to account for such increase in costs. 

        6.2.3    Product Labeling.    The Products supplied to Purchaser will
include Purchaser's NDC number and be packaged in labeling and artwork approved by Purchaser to indicate Purchaser as a distributor of the Product. In order for Purchaser to include in the Product
Label Purchaser Trademarks or similar changes indicating Purchaser as a distributor of the Product; (a) upon Purchaser's request, Seller shall provide Purchaser with the Label artwork and text
in electronic format, (b) Purchaser may update such artwork and text to include Purchaser Trademarks and such other similar changes as desired by Purchaser to indicate Purchaser as a
distributor of the Product, and (c) Purchaser's costs in connection with the foregoing shall be at its sole expense. Thereafter, Seller shall make all necessary arrangements, at its expense
(except as provided in Section 6.2.1 above), to have changed Labels or Labeling printed and shall provide printer's proofs to Purchaser for Purchaser's review. Purchaser shall, within two
(2) weeks of receipt of said printer's proofs, provide written notice to Seller of Purchaser's approval of such proofs in the form submitted by Seller (which approval shall not be unreasonably
conditioned, withheld or delayed) or with such corrections thereto (in Purchaser's reasonable judgment) as included in Purchaser's notice. Thereafter, Seller shall incorporate in such Labels and
Labeling Purchaser's requested corrections thereto, if any, and shall supply Purchaser with examples of such Product Labels and Labeling for Purchaser's regulatory filings;  provided, however, that, if Seller shall not agree with Purchaser's requested corrections, Purchaser and
Seller shall consult in good faith to reach a resolution mutually agreeable to Purchaser and Seller. 

        6.3    Trademarks. All trademarks, tradenames and packaging graphics used by Purchaser in connection with its sale and
distribution of the Product to Purchaser Customers in the Territory (collectively, the "Purchaser Trademarks") shall be chosen by Purchaser in its sole discretion, subject to the terms and conditions
of this Agreement. Purchaser shall be responsible for any and all liabilities which may arise from Purchaser's use of the Purchaser Trademarks (including any allegations of intellectual property
infringement related thereto and any liabilities related to prescription errors related to such trademark usage). Unless consented to in writing by Seller, Purchaser shall not use any trademark,
tradename, company name, or copyright of Seller in connection with the distribution, marketing or sale of the Product. 

14

 

        6.4    Certificate of Analysis. Each shipment of the Product to Purchaser shall be accompanied by a certificate of analysis
prepared by an authorized representative of Seller certifying that the Product in the shipment has been tested in accordance with the ANDA for such Product, meets the Specifications and was
manufactured in material compliance with cGMP (for the avoidance of doubt any non-compliance that would affect Purchaser's sale or distribution of the Product hereunder shall be considered
material). Seller shall deliver such certificate of analysis by facsimile or overnight delivery to Purchaser's distribution facility as designated by Purchaser. 

        6.5    Expiry Dating. Except as otherwise agreed to in writing by Purchaser, all Product shipped to Purchaser, on the date of
shipment by Seller, shall have a shelf-life of at least the approved dating of the Product (per the Product's ANDA) [***]. 

        6.6    Stability Testing. Seller shall maintain a stability testing program for the Product and provide Purchaser with an annual
product review thereon. At least one batch per year of Product shall be included in the stability program. 

        6.7    Annual Report. At Seller's written request, Purchaser will supply distribution information and other information
reasonably requested by Seller, for the purposes of inclusion into Seller's Annual Report to FDA. 

ARTICLE 7  

 TERM  

        7.1    Term. Subject to Article 8, the term of this Agreement shall
commence on the Effective Date and remain in effect for a period of 7 years from the date of Purchaser's First Commercial Sale. Notwithstanding the foregoing, Purchaser shall have the option to
renew this Agreement for an additional term of 3 years from the date of the expiration of the initial term by providing Seller Purchaser's irrevocable written notice thereof 12 months
prior to the end of the initial term. 

ARTICLE 8  

 TERMINATION  

        8.1    Breach. This Agreement may be terminated, prior to the expiration of its term, by either party by giving written notice
of its intent to terminate and stating the grounds therefor if the other party shall have materially breached or materially failed in the observance or performance of any representation, warranty,
guarantee, covenant or obligation under this Agreement. The party receiving the default notice shall have 30 days from the date of receipt thereof to cure the breach or failure, except in the
case of a breach of an obligation to pay money, in which case such cure period shall be 10 days; provided,  however, that nonpayment in connection with
a good faith dispute of the amount in dispute shall not be considered a breach hereof so long as once such
dispute is resolved, payment of any amounts owing is made within 5 days of such resolution. If a breach (other than a breach of an obligation to pay money) is not curable within such
30 day period, then the non-performing party shall have an additional 30 days within which to cure such breach so long as the non-performing party is diligently
working towards a remedy for such breach. In the event such breach or failure is cured in accordance with the provisions of this Section 8.1, the default notice shall become of no effect. In
the event such breach or failure is not cured in accordance with the provisions of this Section 8.1, then this Agreement shall terminate immediately upon written notice to the defaulting party. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

15

 

        8.2    Insolvency, Etc. This Agreement may be terminated, prior to the expiration of its term, immediately upon written notice
by either party: (a) in the event that the other party hereto shall (i) apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trustee or
liquidator of itself or of all or a substantial part of its property, (ii) make a general assignment for the benefit of its creditors, (iii) commence a voluntary case under the United
States Bankruptcy Code, as now or hereafter in effect (the "Bankruptcy Code"), (iv) file a petition seeking to take advantage of any law relating to bankruptcy, insolvency,
reorganization, winding-up, or composition or readjustment of debts, (v) fail to controvert in a timely and appropriate manner, or acquiesce in writing to, any petition filed
against it in any involuntary case under the Bankruptcy Code, or (vi) take any corporate action for the purpose of effecting any of the foregoing; or (b) if a proceeding or case shall be
commenced against the other party hereto in any court of competent jurisdiction, seeking (i) its liquidation, reorganization, dissolution or winding-up, or the composition or
readjustment of its debts, (ii) the appointment of a trustee, receiver, custodian, liquidator or the like of the party or of all or any substantial part of its assets, or (iii) similar
relief under any law relating to bankruptcy, insolvency, reorganization winding-up or composition or readjustment of debts, or an order, judgment or decree approving any of the foregoing
shall be entered and continue unstayed for a period of 60 days; or an order for relief against the other party hereto shall be entered in an involuntary case under the Bankruptcy Code. 

        8.3    Termination Relating to Commercial Launch; Force Majeure, No Increase in Unit Price.

        8.3.1    This Agreement shall terminate in accordance with Section 2.3.2. 

        8.3.2    Purchaser or Seller, as the case may be, may terminate this Agreement as provided for under Section 2.4. 

        8.3.3    Purchaser or Seller, as the case may be, may terminate this Agreement as provided for under Article 12. 

        8.3.4    Seller may terminate this Agreement as provided in Section 4.1.2. 

        8.4    Termination Due to Changed Circumstances. On and after Purchaser's First Commercial Sale, Purchaser or Seller may
terminate this Agreement upon 90 days prior written notice to the other party if Purchaser purchases less than the Minimum Annual Product Units during any rolling twelve month period beginning
after the First Commercial Sale so long as such termination notice is provided to the non-terminating party within 90 days of the end of the twelve month period to which the
termination is based. Notwithstanding the foregoing (unless Purchaser has not ordered at least the Minimum Annual Product Units), Seller's right to terminate this Agreement pursuant to this
Section 8.4 is conditioned upon Seller fulfilling all of Purchaser's Purchase Orders for Product on a timely basis during the twelve month period upon which Seller's exercise of its termination
rights under this Section 8.4 is based. As used herein, the term "Minimum Annual Product Units" shall mean [***] units of Product during any twelve month period
beginning after the First Commercial Sale there are no Authorized Generic Product or Competitive Product being sold and distributed in the Territory and [***] units of Product
during any twelve month period beginning after the
First Commercial Sale in which there are one or more Authorized Generic Products or Competitive Products being sold and distributed in the Territory (which adjustment shall be effective upon the date
of market entry of such Authorized Generic Product or Competitive Product); provided that, in the event of any adjustment to Minimum Annual Product Units during any rolling twelve month period, the
Minimum Annual Product Units existing immediately prior to and after such adjustment shall be prorated as of the effective date of such adjustment for the purpose of calculating the Minimum Annual
Product Units for such twelve month period. 

        8.5    Termination Due to Third Party Infringement Claim. On and after Purchaser's First Commercial Sale, Purchaser may
terminate this Agreement upon 30 days prior written notice to Seller in the event a Third Party Infringement Claim (other than with respect to the use of Purchaser Trademark) is made against
Purchaser or its Affiliates so long as such termination notice is provided to Seller within 15 days of Purchaser receiving written notice of such Third Party Infringement Claim. 

        8.6    Supply Obligations Upon Termination. Upon expiration of this Agreement or any termination of this Agreement after
Purchaser's First Commercial Sale, Seller shall supply and ship, and Purchaser shall purchase from Seller in accordance with the terms and conditions of this Agreement and shall be entitled to
distribute to Purchaser Customers in the Territory, any and all amounts of Products ordered by Purchaser pursuant to Section 5.3 hereof prior to the effective date of such expiration or
termination. 

[***]
Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. 

16

 

        8.7    Effect of Termination. Expiration or termination of this Agreement for any reason shall not release either party hereto
from any liability that at such time had already accrued, or that thereafter accrues from a breach or default, prior to the effective date of such expiration or termination, nor affect in any way the
survival of any other right, duty or obligation of either party hereto which is expressly stated elsewhere in this Agreement to survive such expiration or termination. In addition, termination or
expiration of this Agreement shall in no event release Purchaser from its payment obligations under Article 4, including Purchaser's obligation to pay Seller the Gross Profit Split with respect
to sales of Product whether or not such Product is sold before or after the date of such termination or expiration. Except as expressly provided in Section 3.2.2, no payments to Seller made
pursuant to Article 3 shall be refundable in whole or in part, whether upon termination or expiration of this Agreement or otherwise. Except as otherwise provided herein, either party may
pursue any remedy available in law or in equity with respect to any breach of this Agreement. Sections 2.2.3, 2.3.4 (but only in the event of a termination pursuant to Section 2.3.2), 2.3.5
(but only in the event of a termination pursuant to Section 2.3.2), 2.3.6, 3.2.2, 4.5, 6.7, 8.6, 8.7, Article 13, Article 14, Article 16, Article 17 and, as
applicable, Article 11 and Article 18 hereof shall survive the expiration or termination of this Agreement in accordance with the respective terms thereof. 

ARTICLE 9  

 WAREHOUSING; SHIPMENT  

        9.1    Delivery. Seller shall not be responsible for warehousing finished goods for Purchaser. Purchaser is responsible for any
delivery charges FCA (Incoterms 2000), Seller's designated manufacturing site. All shipments shall be accompanied by a packing slip that describes the articles, states the Purchase Order number and
shows the shipment's destination. Seller shall use Commercially Reasonable Efforts to deliver Product in accordance with the delivery schedule set forth in the Initial Purchase Order or the Purchase
Orders provided in compliance with Section 5.3 hereof. 

        9.2    Shipment. The risk of loss with respect to Product shall be in accordance with FCA (Incoterms 2000), Seller's designated
manufacturing site. Purchaser shall notify Seller within 24 hours of discovery of any lost or stolen goods to facilitate Seller's notification of the FDA. 

ARTICLE 10  

 DEFECTIVE PRODUCT/INSPECTIONS/TESTING  

        10.1    Disposition of Defective Product. Purchaser shall use Commercially Reasonable Efforts, within 20 days after
receipt of any shipment of Product, to notify Seller in writing of the existence and nature of any non-compliance with the Product Warranty observable from a visual inspection. If such
notice is not provided within such 20 day period, then all such Product shall be deemed to be accepted by Purchaser; provided, however, that, any such acceptance or deemed acceptance shall not
adversely affect any applicable Product Warranty or rights to indemnification. If Purchaser notifies Seller of defective Product, then Seller shall have a reasonable opportunity to inspect such
defective Product and provide Purchaser with detailed written instructions to return or dispose of such defective Product at Seller's expense. Whether or not Seller agrees with Purchaser's basis of
rejection, Seller shall, at Purchaser's request, use Commercially Reasonable Efforts to promptly replace the rejected Product. Purchaser shall pay the Transfer Price, and, to the extent Purchaser's
Net Sales derive from the sale of such Product, the applicable Gross Profit Split, for any Product shipped by Seller that replaces Product rejected by Purchaser hereunder. In accordance with
Section 10.2 below, Purchaser shall not be obligated to pay for any properly rejected Product and any such payment shall be promptly returned to Purchaser if Seller agrees with Purchaser's
notice of non-compliance with respect to such rejected Product or such rejected Product is deemed by the independent third-party laboratory to be not in compliance with the Product
Warranty. Purchaser shall not destroy, return or otherwise dispose of the rejected Product until written notification is received from Seller. 

        10.2    Independent Testing. If Seller disagrees with Purchaser's notice of non-compliance as to Product testing
Specifications of the Product to the Product Warranty, the Product shall be submitted to an independent third-party laboratory, mutually and reasonably acceptable to both parties, for analytical
testing to determine the extent of the Product's compliance or non-compliance to the Product Warranty. All costs associated with such third-party laboratory testing shall be at Purchaser's
expense, and Purchaser shall be required to pay the Transfer Price and, in the event Purchaser's Net Sales derive from the sale of such 

17

 

Product,
the applicable Gross Profit Split, for all rejected Product (irrespective of whether Seller has replaced such Product), unless Seller agrees with Purchaser's notice of
non-compliance or the tested Product is deemed by such third-party laboratory to be not in compliance with the Product Warranty, in which case all such costs associated with such
third-party laboratory testing, including reimbursement of freight and disposition costs, shall be promptly reimbursed by Seller to Purchaser and Purchaser shall not be obligated to pay for such
rejected Product and any such payment shall be promptly returned to Purchaser. 

        10.3    Short-Shipment. Purchaser shall notify Seller within 30 days of receipt of any short-shipment claim with respect
to the Product and Seller shall use Commercially Reasonable Efforts to promptly address such claim to Purchaser's reasonable satisfaction. 

ARTICLE 11  

 REGULATORY MATTERS  

        11.1    Adverse Event Reporting; Product Complaints. Purchaser shall have the responsibility in the Territory for complying with
all regulatory filings, reporting requirements and other matters which relate solely to Purchaser acting as a distributor of the Product to Purchaser Customers in the Territory and Seller shall
cooperate with Purchaser as reasonably necessary to accomplish the foregoing. All other regulatory reporting matters (including investigating, evaluating and reporting Adverse Events and other Product
complaints) shall be Seller's responsibility. In this regard, Seller shall be responsible for all reporting to regulatory authorities of all Adverse Events associated with the use of Product.
Purchaser shall notify Seller of any report of an Adverse Event concerning the Product within five (5) calendar days of receipt of the report and provide Seller with information as required by
Applicable Laws or as reasonably requested by Seller. Purchaser shall cooperate with Seller as necessary to report such Adverse Event when so required under Applicable Laws. Purchaser shall also
notify Seller within 10 days of any complaints related to the Product of which it becomes aware regarding problems with the Product other than those associated with Adverse Events, and Seller
shall meet and confer periodically with Purchaser with respect to Seller's responses to such complaints and whether any remedial actions by Purchaser are indicated as necessary or appropriate by the
pattern of complaints, which actions shall be at the expense of the party to the extent its improper acts or omissions caused such complaints. 

        11.2    FDA Communications. Purchaser and Seller agree to promptly notify the other party in the event they receive any
communication or notice from the FDA with respect to the Product or an inspection of the facility where the Product is manufactured, Packaged or stored, and each party shall promptly provide a copy
of such communications to the extent applicable to the Product to the other. The parties shall cooperate in good faith in responding to any such FDA inquiry or in making any report to the FDA with
respect to the Product, but in all cases Seller shall have final authority for regulatory decisions concerning the Product and responsibility for all communications with the FDA. 

        11.3    Recalls.

        11.3.1    In the event of any recall or seizure of any Product, other than a Purchaser Recall (as defined below) Seller shall,
at the written election of Purchaser and at Seller's sole cost, either: 

        (a)   undertake Commercially Reasonable Efforts to replace the amount of Product recalled or seized; or 

        (b)   give credit to Purchaser against outstanding receivables due from Purchaser in an amount equal to the amount paid by
Purchaser for the Product (including any Gross Profit Split paid to Seller on such Product) so recalled or seized or otherwise owing by Purchaser hereunder; 

plus
reimburse (or, at the written election of Purchaser, credit) Purchaser for the aggregate and reasonable transportation costs, taxes, freight insurance, handling and reasonable and verifiable
out-of-pocket costs incurred by Purchaser in respect of such recalled or seized Product. 

        11.3.2    In the event of any recall or seizure of any Product occurring primarily as a result of any breach of this Agreement
by, or negligent acts of omissions or intentional misconduct of, Purchaser or its Affiliates (a "Purchaser Recall"), (i) if such Purchaser Recall is classified by FDA as a Class I
recall, Seller shall be responsible (as between Purchaser and Seller) for such recalled or seized Product and shall bear all costs of such recall or seizure, (ii) if such Purchaser Recall is
classified by FDA as a 

18

 

Class II
recall, Seller shall be responsible (as between Purchaser and Seller) for such recalled or seized Product and the parties shall share equally all costs of such recall or seizure and
(iii) if such Purchaser Recall is classified by FDA as a Class III recall, Purchaser shall be responsible (as between Purchaser and Seller) for such recalled or seized Product and shall
bear all costs of such recall or seizure, including reimbursement of Seller of any reasonable and verifiable out-of-pocket costs incurred by Seller related to the recall or
seizure of such Product. Purchaser's costs with respect to any Purchaser Recall as set forth above shall not be deducted in connection with the calculation of Purchaser's Net Sales or Gross Profit
hereunder. 

        11.3.3    For purposes of this Section 11.3, "recall" shall mean (i) any action by Seller, Purchaser, any
Affiliate of either to recover title to or possession of any Product sold or shipped and/or (ii) any decision by Purchaser not to sell or ship Product to third parties which would have been
subject to recall or seizure if it had been sold or shipped, in each case taken in the good faith belief that such action was appropriate or required under the circumstances. For purposes of this
Section 11.3, "seizure" shall mean any action by any government agency to detain or destroy any Product. Notwithstanding anything to the contrary in this
Section 11.3, Seller shall have final authority with respect to any recall of the Product and neither Purchaser nor its Affiliates shall initiate any recall of the Product without Seller's
prior written approval (such approval not to be unreasonably conditioned, withheld or delayed). 

        11.3.4    Seller and Purchaser shall keep the other fully informed of any notification or other information, whether received
directly or indirectly, that might affect the marketability, safety or effectiveness of the Product, or which might result in liability issues or otherwise necessitate action on the part of either
party, or which might result in recall or seizure of any Product. Purchaser shall maintain records of all sales of Product and customers reasonably sufficient to adequately administer a recall or
seizure for the longer of three years after termination or expiration of this Agreement or the period required by Applicable Law. Seller will be responsible for assuring that such recall is
closed-out with the FDA, unless the FDA shall otherwise require. 

        11.4    Inspections.

        11.4.1    Seller shall use Commercially Reasonable Efforts to maintain and operate the manufacturing facility designated in the
ANDA, and to implement such quality control procedures, so as to cause Seller to be able to perform its obligations hereunder. Upon Purchaser's written request and at its expense, Seller shall permit
quality assurance representatives of Purchaser (reasonably acceptable to Seller) to inspect such manufacturing facility, at all times accompanied by a representative of Seller, upon reasonable notice,
during normal business hours and on a confidential basis. Such inspection shall be limited to an assessment of such facility's compliance with cGMP and other quality assurance standards as such relate
to the manufacture of the Product. Seller shall also permit Purchaser reasonable periodic visits to discuss and review manufacturing and supply issues with management of Seller. 

        11.4.2    In the event Seller's manufacturing, Packaging, testing or storage facility producing the Product hereunder is
inspected by representatives of any federal, state, or local agency in connection with Seller's manufacture, Packaging, testing or storage of Product, then Seller shall notify the Purchaser promptly
upon learning of such inspection, and shall, within 10 days of such notice, supply Purchaser with copies of any correspondence or portions of correspondence which relate to the Product in
Seller's possession. If Seller is informed that a representative of any federal, state, or local agency will be conducting an audit of Seller's manufacturing facility and such audit specifically
relates to the Product, then Seller will, to the extent reasonably practicable, provide advance notice to Purchaser to permit Purchaser to observe and attend such audit. In the event Seller receives
any regulatory letter or comments from any federal, state, or local agency in connection with its manufacture, Packaging, testing or storage of the Product requiring a response or action by Seller,
including receipt of a Form 483 (Inspectional Observations) or a "Warning Letter," Seller shall promptly following Seller's receipt thereof, provide Purchaser with a copy of such communication
which relate to the Product. At Seller's request, Purchaser will provide Seller with any and all data or information reasonably required to prepare a response to such communication. Seller shall
consult Purchaser with respect to any response relating to the Product; provided, however, that, as between Seller and Purchaser, Seller shall make the final determination as to any such response
submitted to the regulatory authorities. Seller shall promptly 

19

 

provide
Purchaser with a copy of any final response which relate to the Product after its submission to the regulatory authority. 

        11.4.3    Purchaser shall use Commercially Reasonable Efforts to maintain and operate any facility of Purchaser at which the
Product is stored or distributed in compliance with cGMP and other quality assurance standards as such relate to the Product. Upon Seller's written request and at its expense, Purchaser shall permit
quality assurance representatives of Seller (reasonably acceptable to Purchaser) to inspect any facility of Purchaser at which the Product is stored or distributed. Such inspection shall be limited to
an assessment of such facility's compliance with cGMP and other quality assurance standards as such relate to the Product. In the event Purchaser is inspected or receives a regulatory letter or
comments from any federal agency in connection with its sale or distribution of the Product, Purchaser shall notify Seller promptly upon learning of such inspection and/or provide Seller copies of
such correspondence upon receiving such documentation. Seller shall have the right to, and at Purchaser's written request shall, participate in that portion of such inspection relating to the Product.
Regardless of whether Seller does participate as described above, Seller and Purchaser shall consult with respect to the response relating to the Product. Seller will provide Purchaser at Purchaser's
request with all data or information reasonably required to prepare a response relating to the Product, and Purchaser will promptly provide Seller with a copy of any final response submitted to the
regulatory authority. 

        11.4.4    Seller will notify Purchaser within one day of any finished Product lot that results in a positive sterility test out
of specification (OOS) condition, whether or not that lot was released or distributed, whether or not the positive sterility result was subsequently investigated and attributed to an assignable cause.
In addition, Seller will notify Purchaser within one day of any stability test for the Product that results in an OOS condition relating to the Product Specifications, whether or not the OOS condition
was subsequently investigated and attributed to an assignable cause. To the extent it is not reasonably practicable for Seller to provide notice within the one day period required by this Section,
Seller will not be deemed to be in breach of this Agreement if it provides the required notice as soon as it is reasonably practicable. Seller will also provide quarterly reports to Purchaser of the
number of lots of Product made and the number of lot failures during the preceding quarter and shall reasonably respond to any information requests relating thereto. 

        11.5    Sales and Marketing Activities. Purchaser shall be responsible for establishing a formal written program in compliance
with the California Comprehensive Compliance Program pursuant to California Health and Safety Code Sections 119400 et. seq., on or before July 1, 2005, for all applicable activities of
Purchaser and its Affiliates related to the Product which are subject to this code section. Upon request of Seller, Purchaser shall provide Seller with reasonable evidence of its compliance with this
Section 11.5. 

        11.6    Cooperation. Seller shall provide reasonable assistance to Purchaser in its preparation and filing with appropriate
regulatory agencies (both federal and state agencies related to reimbursement and health care insurance) of filings required for the marketing, and distribution of the Product to Purchaser Customers
in the Territory by Purchaser. Seller and Purchaser shall cooperate in good faith to develop such necessary regulatory strategies which may be required for purposes of this Agreement, and to allow the
Product to be listed on applicable formularies and other drug listings as reasonably requested by Purchaser, and making any applicable filings or registrations to allow the Product to be included on
such formularies or listings, including Medicare and Medicaid. 

ARTICLE 12

FORCE MAJEURE  

        12.1    Force Majeure. If either party is prevented from performing any of its obligations hereunder (except for any monetary
payments due hereunder) due directly or indirectly to fire; flood; accident; explosion; equipment or machinery breakdown; sabotage; strike; or any labor disturbance; civil commotions; riots'
invasions; wars (present or future); acts, restraints, requisitions, regulations, or directions or orders of any governmental entity; compliance with any request of any governmental entity; compliance
with any request for material represented to be for purposes of (directly or indirectly) producing articles for national defense or national defense facilities; shortage of labor, fuel, power or raw
materials; inability to obtain raw materials or supplies; failures of normal sources of supplies; inability to obtain or delays of transportation facilities; any act of God; any act of the other party
or other causes (whether similar or dissimilar to the foregoing); in each case so long as such cause is beyond the reasonable control of such party (a "Force 

20

 

Majeure
Event"), such non-performing party shall not be liable for breach of this Agreement with respect to such non-performance if and to the extent any such
non-performance is due to a Force Majeure Event. Such non-performance will be excused for as long as such event shall be continuing; provided that, the
non-performing party gives immediate written notice to the other party of the Force Majeure Event. Such non-performing party shall exercise all reasonable efforts to eliminate
the Force Majeure Event and to resume performance of its affected obligations as soon as practicable. In the event that, as a result of such Force Majeure Event, a party does not perform all of its
obligations hereunder for any period aggregating 120 days within any 360-day period, the other party may terminate this Agreement on 30 days prior written notice to the
non-performing party. 

ARTICLE 13  

 INSURANCE  

        13.1    Insurance. Each party agrees to procure and maintain in full force and effect during the term of this Agreement and
continuing for a period of not less than 36 months following the termination or expiration hereof, at its sole cost and expense, product liability insurance in amounts of not less than
$2,000,000 per incident and $5,000,000 annual aggregate (provided that within 60 days after Purchaser's payment of the amount to Seller under Section 3.1(b), the annual aggregate shall
be increased to $10,000,000) which insurance shall be written on a "claims made" basis policy form with a reputable insurance carrier and name the other party as an additional insured. Each party
shall, on request, provide to the other party a copy of a certificate of coverage or other written evidence reasonably satisfactory to such requesting party of such insurance coverage. Either party
may substitute a program of self-insurance for all or part of the third party insurance required hereunder if reasonably satisfactory to the other party. 

ARTICLE 14  

 CONFIDENTIALITY  

        14.1    Confidentiality. As used herein, "Confidential Information" shall include all confidential or proprietary information
given to one party by the other party, or otherwise acquired by such party in its performance of this Agreement, relating to such other party or any of its Affiliates, including information regarding
any of the products of such other party or any of its Affiliates, information regarding its advertising, distribution, marketing or strategic plans or information regarding its costs, productivity or
technological advances, specifications, data, know-how, formulations, product concepts, sample materials, manufacturing processes and other manufacturing information, business and
technical information, pricing and other deal terms, whether in written form or disclosed orally, visually and/or in another tangible form. Neither party shall use, exploit or disclose to third
parties any Confidential Information of the other and each party shall insure that its and its Affiliates' employees, officers, representatives and agents shall not use or disclose to third parties
any Confidential Information and upon the termination of this Agreement shall return to the other or destroy all Confidential Information in written form. Confidential Information shall not include
information that (i) was lawfully already known to receiving party at the time of its receipt thereof, (ii) is disclosed to receiving party after its receipt thereof by a third party who
has a right to make such disclosure without violating any obligation of confidentiality, (iii) is or becomes generally available to the public through no fault of receiving party or
(iv) is independently developed by the receiving party as demonstrated by such party pursuant to contemporaneous written records. The obligations of confidentiality set out above shall survive
termination or expiration of this Agreement for a period of 10 years. Notwithstanding the foregoing, in the event that a party is required under Applicable Law, the rules or regulations of any
stock exchange or listing body upon which the stock of a party or a party's parent corporation may then be traded, or by governmental agency or court of competent jurisdiction to disclose the
Confidential Information of the other party, such party shall promptly notify the other party in writing of all details of the required disclosure and permit the other party a reasonable opportunity
to intervene to oppose, limit or condition such disclosure prior to making such disclosure, and such party shall make any such disclosure ultimately required in the most restrictive fashion, in its
reasonable judgment, consistent with the applicable requirement requiring such disclosure. 

21

 
ARTICLE 15  

 PUBLIC ANNOUNCEMENTS; ETC.  

        15.1    Public Announcements. No public announcement, news release, statement, publication, or presentation relating to the
existence of this Agreement, the subject matter hereof, or either party's performance hereunder will be made without the other party's prior written approval, which approval shall not be unreasonably
conditioned, withheld or delayed. Notwithstanding the foregoing, and subject to the provisions
of Article 14 with respect to Confidential Information, either party may make any public disclosure relating to the existence of this Agreement, the subject matter hereof and its terms, or
either party's performance hereunder that is deemed necessary, in the reasonable judgment of a party, to comply with Applicable Laws or with the rules or regulations of any stock exchange or listing
body upon which the securities of a party or a party's parent corporation may then or are intended to be traded or of any governmental agency (e.g., the Securities and Exchange Commission) which
regulates such securities (including the filing of a copy of this Agreement with such governmental agency); provided that, the party making such disclosure shall provide the non-disclosing
party with a copy of the intended disclosure reasonably, and to the extent practicable, prior to public dissemination. 

        15.2    No Use of Other Party's Name. Neither party shall use the name of the other party or any of its Affiliates for
advertising, promotional or other purposes without the prior written consent of the other party. 

ARTICLE 16  

 REPRESENTATIONS AND WARRANTIES  

        16.1    Product Warranty.

        16.1.1    Seller represents and warrants to Purchaser that all Product supplied in connection with this Agreement shall:
(i) be manufactured, packaged, tested, stored and handled in compliance in all material respects with cGMP and all other Applicable Laws (for the avoidance of doubt any
non-compliance that would affect Purchaser's sale or distribution of the Product hereunder shall be considered material); and (ii) meet the Specifications and the Product's ANDA and
not be adulterated or misbranded within the meaning of the Act (each of clauses (i) and (ii) being referred to collectively herein as the "Product Warranty"). The foregoing Product
Warranty shall not apply to the extent that the failure of any such Product to meet the requirements of this Section 16.1.1 is caused by the negligent acts or omissions or intentional
misconduct of Purchaser, its Affiliates, wholesalers or other customers (including modification or misuse or improper storage or transportation of the Product after shipment to Purchaser, whether by
Purchaser, its Affiliates or any other Person). 

        16.1.2    EXCEPT AS EXPRESSLY PROVIDED IN SECTION 16.1.1 ABOVE, SELLER MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE
PRODUCT OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE PRODUCT IS FREE FROM THE RIGHTFUL CLAIM OF ANY
THIRD PARTY, BY WAY OF INFRINGEMENT OR THE LIKE. 

        16.2    Warranties with Regard to Status.

        16.2.1    Purchaser hereby represents and warrants to Seller that neither it nor any of its Affiliates is prohibited under any
Applicable Laws from selling and distributing the Product (assuming that the ANDA for the
Product is approved by FDA) within the Territory and that neither Purchaser nor any of its Affiliates is a person that is listed by a United States federal agency as debarred, suspended, proposed for
debarment or otherwise ineligible for federal programs in the Territory. 

        16.2.2    Seller hereby represents and warrants to Purchaser that neither it nor any of its Affiliates is prohibited under any
Applicable Laws from manufacturing, selling and distributing the Product (assuming that the ANDA for the Product is approved by FDA) within the Territory and that neither Seller nor any of its
Affiliates is a person that is listed by a United States federal agency as debarred, suspended, proposed for debarment or otherwise ineligible for federal programs in the Territory. 

22

 

        16.3    Purchaser Warranties. Purchaser hereby represents warrants and covenants that: 

        (a)   Purchaser Trademarks may be lawfully used as directed by Purchaser; 

        (b)   the Product Label, if Labeled in accordance with specifications provided by Purchaser, will comply with the ANDA for the
Product and Applicable Laws; and, 

        (c)   neither Purchaser nor its Affiliates has filed with the FDA an ANDA for a generic equivalent to Lovenox®. 

        16.4    Execution and Performance of Agreement. Each of Seller and Purchaser represents and warrants to the other that it has
full right, power and authority to enter into and perform its obligations under this Agreement. Each of Seller and Purchaser further represents and warrants to the other that the performance of its
obligations under this Agreement will not result in a violation or breach of, and will not conflict with or constitute a default under any agreement, contract, commitment or obligation to which such
party or any of its Affiliates is a party or by which it is otherwise bound or any Applicable Law. 

        16.5    LIMITATION ON LIABILITY OF PARTIES. EXCEPT WITH RESPECT TO (A) A CLAIM FOR BREACH UNDER ARTICLE 14 ABOVE,
(B) A CLAIM FOR WILLFUL MISCONDUCT OR FRAUD AND (C) AMOUNTS PAYABLE TO A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION PURSUANT TO ARTICLE 17 BELOW, IN NO EVENT SHALL EITHER PARTY BE
LIABLE TO THE OTHER PARTY FOR LOSS OF PROFITS OR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES RESULTING FROM THIS AGREEMENT. 

ARTICLE 17  

 INDEMNIFICATION  

        17.1    Indemnification by Seller. Seller shall indemnify, defend and hold harmless Purchaser (and its Affiliates) from and
against any and all damages, liabilities, claims, costs, charges, judgments and expenses (including reasonable attorneys' fees) (collectively "Damages") that may be sustained, suffered or incurred by
Purchaser (or its Affiliates) arising from or relating to any claim, action or proceeding made or brought by a third party against the Purchaser (or its Affiliates) to the extent arising from
(a) the actual or alleged breach by Seller of any warranty, representation, covenant or agreement made by Seller in this Agreement; (b) negligent acts or omissions or intentional
misconduct of Seller or its Affiliates; (c) any Product recall or seizure (other than a Purchaser Recall to the extent provided under Section 11.3.2); or (d) any Product Liability
Claims (other than as provided in Section 17.2(d) below); provided, however, that in each such case above, Seller shall not be liable to Purchaser hereunder to the extent such Damages arise
from the negligent acts or omissions or intentional misconduct of Purchaser or its Affiliates, wholesalers or other customers (including modification or misuse or improper storage or transportation of
the Product after shipment to Purchaser, whether by Purchaser, its Affiliates or any other Person) or such other actions or inactions for which Purchaser is obligated to indemnify Seller under
Section 17.2 below. 

        17.2    Indemnification by Purchaser. Purchaser shall indemnify, defend and hold harmless Seller (and its Affiliates) from and
against any and all Damages, that may be sustained, suffered or incurred by Seller (or its Affiliates) arising from or relating to any claim, action or proceeding made or brought by a third party
against the Seller (or its Affiliates) to the extent arising from (a) the actual or alleged breach by Purchaser of any warranty, representation, covenant or agreement made by Purchaser in this
Agreement; (b) improper Product marketing, sales or distribution activities of Purchaser or its Affiliates, including any commercial arrangements entered into by Purchaser with its customers or
other third parties; (c) negligent acts or omissions or intentional misconduct of Purchaser or its Affiliates (including modification or misuse or improper storage or transportation of the
Product by Purchaser, its Affiliates or other Person acting on behalf of Purchaser or its Affiliates, excluding wholesalers and customers); (d) any Product Liability Claims to the extent
arising from Purchaser's breach hereof or the negligent acts or omissions or intentional misconduct of Purchaser and its Affiliates (including modification or misuse or improper storage or
transportation of the Product by Purchaser, its Affiliates or other Person acting on behalf of Purchaser or its Affiliates, excluding wholesalers and customers); or (e) any Purchaser Recall
(except as otherwise provided in Section 11.3.2); provided, however, that, in each such case above, Purchaser shall not be liable to Seller hereunder to the extent such Damages arise from the
negligent acts or omissions or intentional misconduct 

23

 

of
Seller or its Affiliates or such other actions or inactions for which Seller is obligated to indemnify Purchaser under Section 17.1 above. 

        17.3    Claims. Each indemnified party agrees to give the indemnifying party prompt written notice of any matter upon which such
indemnified party intends to base a claim for indemnification under this Article 17; provided, however, that failure to give such prompt notification shall not affect the indemnification
provided hereunder except to the extent the indemnifying party shall have been actually materially prejudiced as a result of such failure. The indemnified party shall permit, and shall cause its
employees and agents to permit,
the indemnifying party to defend or settle any such action, claim or liability and agrees to the complete control of such defense or settlement by the indemnifying party; provided, however, that such
settlement does not impose any obligation or burden on the indemnified party without the prior written consent of the indemnified party. No such action, claim or liability shall be settled by the
indemnified party without the prior written consent of the indemnifying party (which consent shall not be unreasonably conditioned, withheld or delayed) and the indemnifying party shall not be
responsible for any fees or other costs incurred other than as provided in this Article 17. The indemnified party, its employees, agents and affiliates shall cooperate reasonably with the
indemnifying party and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification at the sole expense of the indemnifying party. The
indemnified party shall have the right, but not the obligation, to be represented by counsel of its own selection and at its own expense. Notwithstanding Sections 17.1 and 17.2 above, and by way of
clarification, neither party shall be obligated to indemnify the other party hereunder for modification or misuse or improper storage or transportation of the Product by wholesalers or the customers
of either party. 

        17.4    Third Party Infringement Claims. In the event any claim or action for infringement of any patent, trademark, or other
intellectual property right shall be made or brought by a third party against Seller, Purchaser or any of their respective Affiliates because of, or in anticipation of, the manufacture and supply of
Product by Seller to Purchaser hereunder, or the marketing, sale or distribution of such Product to Purchaser Customers in the Territory by Purchaser hereunder (a "Third Party Infringement Claim"),
the party first receiving such notice of the Third Party Infringement Claim shall promptly notify the other party. With respect to the Third Party Infringement Claim, Seller and Purchaser each hereby
agrees that all Damages arising from or related to the Third Party Infringement Claim (including any legal fees and associated costs incurred in defending the Third Party Infringement Claim and any
fees, royalties or other amounts paid in settlement or upon judgment) shall be shared as follows: 

        (a)   Except as provided in clause (b) below, Seller shall be 100% responsible for all Damages arising from any Third
Party Infringement Claim, including any fees, royalties or other amounts agreed to be paid in settlement or upon judgment of the Lawsuit or otherwise; and 

        (b)   Purchaser shall be 100% responsible for all Damages arising from any Third Party Infringement Claim with respect to the
use of Purchaser Trademarks. 

Each
party agrees to indemnify the other party to ensure that Damages arising from any Third Party Infringement Claim are allocated in accordance with clauses (a) and (b) above. Unless
otherwise agreed to by the parties, Seller shall control the defense any Third Party Infringement Claim described in clause (a) above and Purchaser shall control the defense of any Third Party
Infringement Claim described in clause (b) above. The party controlling the defense of any Third Party Infringement Claim shall have the sole right to defend or settle any such Third Party
Infringement Claim; provided, however, that such settlement does not impose any obligation or burden on the other party without the prior written consent of the other party (which consent shall not be
unreasonably withheld). The party controlling the defense of any Third Party Infringement Claim shall keep the other party, at its request, materially informed of the status and progress of the
defense of the Third Party Infringement Claim. No Third Party Infringement Claim shall be settled by the party who is not controlling the defense of such Third Party Infringement Claim without the
prior written consent of the party controlling such defense. The non-controlling party, its employees, agents and Affiliates shall reasonably cooperate with the party (and its legal
representatives) controlling the defense of any Third Party Infringement Claim in the investigation and defense of such Third Party Infringement Claim. Notwithstanding the above, and by way of
clarification, neither party shall be obligated to indemnify the other party hereunder for modification or misuse of the Product by the other party or by wholesalers or the customers of either party.
The provisions of this Section 17.4 shall be notwithstanding any conflicting provisions set forth in this Agreement, including Sections 17.1, 17.2 and 17.3. 

24

 

        17.5    No Right of Offset. Purchaser shall have no right to set off or retain any amounts otherwise payable to Seller under
Articles 3 or 4 of this Agreement, including any amounts payable to satisfy any indemnification claims Purchaser may have hereunder. 

ARTICLE 18  

 MISCELLANEOUS  

        18.1    Governing Law. This Agreement and all acts and transactions pursuant hereto and the rights and obligations of the
parties hereto shall be governed, construed and interpreted in accordance with the laws of the State of New York, without reference to rules of conflicts or choice of laws. 

        18.2    Relationship of the Parties. The relationship of Purchaser and Seller established by this Agreement is that of
independent contractors, and nothing contained herein shall be construed to (i) give either party any right or authority to create or assume any obligation of any kind on behalf of the other or
(ii) constitute the parties as partners, joint venturers, co-owners or otherwise as participants in a joint or common undertaking. 

        18.3    Third Party Rights. Nothing in this Agreement shall be deemed to create any third party beneficiary rights in or on
behalf of any other person. 

        18.4    Entire Agreement. It is the mutual desire and intent of the parties to provide certainty as to their respective future
rights and remedies against each other by defining the extent of their mutual undertakings as provided herein. The parties have in this Agreement incorporated all representations, warranties,
covenants, commitments and understandings on which they have relied in entering into this Agreement, and, except as provided for herein, neither party makes any covenant or other commitment to the
other concerning its future action. Accordingly, this Agreement (i) constitutes the entire agreement and understanding between the parties with respect to the subject matter hereof and there
are no promises, representations, conditions, provisions or terms related thereto other than those set forth in this Agreement and (ii) supersedes all previous understandings, agreements and
representations between the parties, written or oral. No modification, change or amendment to this Agreement shall be effective unless in writing signed by each of the parties hereto. 

        18.5    Interpretation. Unless the context of this Agreement otherwise requires, (i) words of any gender include each
other gender; (ii) words using the singular or plural number also include the plural or singular number, respectively; (iii) the terms "hereof," "herein," "hereby," and derivative or
similar words refer to this entire Agreement; (iv) the terms "Article" and "Section" refer to the specified Article and Section of this Agreement, and (v) the terms "include,"
"includes," or "including" shall be deemed to be followed by the words "without limitation" unless otherwise indicated. Whenever this Agreement refers to a number of days, unless otherwise specified,
such number shall refer to calendar days. The headings in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. 

        18.6    Notices. All notices and other communications hereunder shall be in writing. All notices hereunder of an indemnity
claim, a Force Majeure Event, default or breach hereunder, or, if applicable, termination or renewal of the term hereof, or any other notice of any event or development material to this Agreement
taken as a whole, shall be delivered personally, or sent by national overnight delivery service or postage pre-paid registered or certified U.S. mail, or facsimile, and shall be deemed
given: when delivered, if by personal delivery or overnight delivery service; five business days after deposit in the U.S. mail, if mailed; or upon receipt of electronic confirmation of transmission,
if sent by facsimile and followed on the same day by deposit in the U.S. mail. Notice shall be addressed: 

        If
to Seller: 

Amphastar
Pharmaceuticals, Inc.

11570 Sixth Street

Rancho Cucamonga, California 91730

Attention: Chief Financial Officer

Telephone: (909) 980-9484

Fax: (909) 980-8296 

25

 

        If
to Purchaser: 

Andrx
Pharmaceuticals, Inc.

8151 Peters Road, Fourth Floor

Plantation, Florida 33324

Attention Lawrence Rosenthal, President

Telephone: (954) 382-7608

Fax: (954) 382-7716 

        With
a copy (which shall not constitute notice) to: 

Andrx
Corporation

8151 Peters Road, Fourth Floor

Plantation, Florida 33324

Attention: Scott Lodin, Esq.,

                  Executive Vice President and General Counsel

Telephone: (954) 382-7614

Fax: (954) 382-7744 

or
to such other place as either party may designate by written notice to the other in accordance with the terms of this Section 18.6. 

        18.7    No Waiver. The failure of either party to enforce at any time for any period any provision hereof shall not be construed
to be a waiver of such provision or of the right of such party thereafter to enforce each such provision, nor shall any single or partial exercise of any right or remedy hereunder preclude any other
or further exercise thereof or the exercise of any other right or remedy. Subject to any express provisions to the contrary contained herein, the remedies provided herein are cumulative and not
exclusive of any remedies provided at law. 

        18.8    Assignment. This Agreement may not be assigned or delegated by either party without the prior written consent of the
other, except that either party may assign or delegate its rights and/or obligations hereunder to any of its Affiliates, to a successor to all of its business, or to a successor to that portion of its
business which relates to the Product. Subject to the foregoing and the other terms of this Agreement, this Agreement shall bind and inure to the benefit of the parties hereto and their respective
successors and permitted assigns. 

        18.9    Severability. In the event that any one or more of the terms or provisions (or any part thereof) contained in this
Agreement or in any other instrument referred to herein, shall, for any reason, be held to be invalid, illegal or unenforceable in any respect pursuant to a final, non-appealable decision,
then to the maximum extent permitted by law, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or any other such instrument. Any term or
provision of this Agreement that is so held to be invalid, illegal or unenforceable in any jurisdiction shall, to the extent the economic benefits conferred by this Agreement to both parties remain
substantially unimpaired, not affect the validity, legality or enforceability of any of the terms or provisions of this Agreement in any other jurisdiction. 

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

        18.11    Expenses. Each party shall pay all of its own fees and expenses (including all legal, accounting and other advisory
fees) incurred in connection with the negotiation and execution of this Agreement and the arrangements contemplated hereby. 

[SIGNATURE PAGE FOLLOWS]

26

 

        IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized respective representatives as of the day and year first above written. 

	

 	
 	

AMPHASTAR PHARMACEUTICALS, INC.
	

 	
 	

By:	
 	

/s/  DAVID W. NASSIF      

	

 	
 	

Name:	
 	

David W. Nassif

	

 	
 	

Title:	
 	

CFO and Senior Vice President of Global Licensing

	

 	
 	

ANDRX PHARMACEUTICALS, INC.
	

 	
 	

By:	
 	

/s/  LAWRENCE J. ROSENTHAL      

	

 	
 	

Name:	
 	

Lawrence J. Rosenthal

	 	 	Title:	 	President

27

QuickLinks

Exhibit 10.28

DISTRIBUTION AGREEMENT

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00092-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00092-of-00352.parquet"}]]