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EXHIBIT 4.9    
    

FORM OF SUBORDINATED DEBT

SECURITIES INDENTURE  

       

SUPERIOR ESSEX INC.  

INDENTURE  

 DATED AS OF                            , 200    

      

THE BANK OF NEW YORK TRUST COMPANY, N.A.  

 TRUSTEE  

       

SUBORDINATED
DEBT SECURITIES 

  

 
 

TABLE OF CONTENTS    
    

	ARTICLE I.    DEFINITIONS AND INCORPORATION BY REFERENCE	 	1
	 	Section 1.1.	 	Definitions	 	1
	 	Section 1.2.	 	Definitions	 	4
	 	Section 1.3.	 	Incorporation by Reference of Trust Indenture Act	 	4
	ARTICLE II.    SECURITIES	 	5
	 	Section 2.1.	 	Amount Unlimited; Issuable in Series	 	5
	 	Section 2.2.	 	Establishment of Terms of Series of Securities	 	5
	 	Section 2.3.	 	Authentication and Delivery of Securities	 	7
	 	Section 2.4.	 	Execution of Securities; Trustee's Certificate of Authentication; Form of Securities	 	8
	 	Section 2.5.	 	Registrar and Paying Agent	 	9
	 	Section 2.6.	 	Paying Agent to Hold Money in Trust	 	9
	 	Section 2.7.	 	Securityholder Lists	 	9
	 	Section 2.8.	 	Transfer and Exchange	 	10
	 	Section 2.9.	 	Mutilated, Destroyed, Lost and Stolen Securities	 	10
	 	Section 2.10.	 	Outstanding Securities	 	11
	 	Section 2.11.	 	Treasury Securities	 	11
	 	Section 2.12.	 	Temporary Securities	 	11
	 	Section 2.13.	 	Cancellation	 	12
	 	Section 2.14.	 	Defaulted Interest	 	12
	 	Section 2.15.	 	Global Securities	 	12
	 	Section 2.16.	 	CUSIP Numbers	 	13
	ARTICLE III.    REDEMPTION	 	13
	 	Section 3.1.	 	Notice to Trustee	 	13
	 	Section 3.2.	 	Selection of Securities to be Redeemed	 	13
	 	Section 3.3.	 	Notice of Redemption	 	14
	 	Section 3.4.	 	Effect of Notice of Redemption	 	14
	 	Section 3.5.	 	Deposit of Redemption Price	 	14
	 	Section 3.6.	 	Securities Redeemed in Part	 	14
	ARTICLE IV.    COVENANTS	 	14
	 	Section 4.1.	 	Payment of Principal and Interest	 	14
	 	Section 4.2.	 	SEC Reports	 	14
	 	Section 4.3.	 	Compliance Certificate	 	15
	 	Section 4.4.	 	Stay, Extension and Usury Laws	 	15
	 	Section 4.5.	 	Corporate Existence	 	15
	ARTICLE V.    SUCCESSORS	 	15
	 	Section 5.1.	 	When Company May Merge, Etc	 	15
	 	Section 5.2.	 	Successor Corporation Substituted	 	16
	ARTICLE VI.    DEFAULTS AND REMEDIES	 	16
	 	Section 6.1.	 	Events of Default	 	16
	 	Section 6.2.	 	Acceleration of Maturity; Rescission and Annulment	 	17
	 	Section 6.3.	 	Collection of Indebtedness and Suits for Enforcement by Trustee	 	18
	 	Section 6.4.	 	Trustee May File Proofs of Claim	 	18
	 	Section 6.5.	 	Trustee May Enforce Claims Without Possession of Securities	 	19
	 	Section 6.6.	 	Application of Money Collected	 	19
	 	Section 6.7.	 	Limitation on Suits	 	19
	 	Section 6.8.	 	Unconditional Right of Holders to Receive Principal and Interest	 	20
	 	Section 6.9.	 	Restoration of Rights and Remedies	 	20
	 	Section 6.10.	 	Rights and Remedies Cumulative	 	20
	 	 	 	 	 

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	 	Section 6.11.	 	Delay or Omission Not Waiver	 	20
	 	Section 6.12.	 	Control by Holders	 	20
	 	Section 6.13.	 	Waiver of Past Defaults	 	20
	 	Section 6.14.	 	Undertaking for Costs	 	21
	ARTICLE VII.    TRUSTEE	 	21
	 	Section 7.1.	 	Duties of Trustee	 	21
	 	Section 7.2.	 	Rights of Trustee	 	22
	 	Section 7.3.	 	Individual Rights of Trustee	 	22
	 	Section 7.4.	 	Trustee's Disclaimer	 	23
	 	Section 7.5.	 	Notice of Defaults	 	23
	 	Section 7.6.	 	Reports by Trustee to Holders	 	23
	 	Section 7.7.	 	Compensation and Indemnity	 	23
	 	Section 7.8.	 	Replacement of Trustee	 	24
	 	Section 7.9.	 	Successor Trustee by Merger, Etc	 	24
	 	Section 7.10.	 	Eligibility; Disqualification	 	25
	 	Section 7.11.	 	Preferential Collection of Claims Against Company	 	25
	ARTICLE VIII.    SATISFACTION AND DISCHARGE; DEFEASANCE	 	25
	 	Section 8.1.	 	Satisfaction and Discharge of Indenture	 	25
	 	Section 8.2.	 	Application of Trust Funds; Indemnification	 	26
	 	Section 8.3.	 	Legal Defeasance of Securities of any Series	 	26
	 	Section 8.4.	 	Covenant Defeasance	 	27
	 	Section 8.5.	 	Repayment to Company	 	27
	ARTICLE IX.    AMENDMENTS AND WAIVERS	 	27
	 	Section 9.1.	 	Without Consent of Holders	 	27
	 	Section 9.2.	 	With Consent of Holders	 	28
	 	Section 9.3.	 	Compliance with Trust Indenture Act	 	29
	 	Section 9.4.	 	Revocation and Effect of Consents	 	29
	 	Section 9.5.	 	Notation on or Exchange of Securities	 	29
	 	Section 9.6.	 	Trustee Protected	 	29
	ARTICLE X.    MISCELLANEOUS	 	30
	 	Section 10.1.	 	Trust Indenture Act Controls	 	30
	 	Section 10.2.	 	Notices	 	30
	 	Section 10.3.	 	Communication by Holders with Other Holders	 	31
	 	Section 10.4.	 	Certificate and Opinion as to Conditions Precedent	 	31
	 	Section 10.5.	 	Statements Required in Certificate or Opinion	 	31
	 	Section 10.6.	 	Rules by Trustee and Agents	 	31
	 	Section 10.7.	 	Legal Holidays	 	31
	 	Section 10.8.	 	No Recourse Against Others	 	31
	 	Section 10.9.	 	Counterparts	 	32
	 	Section 10.11.	 	No Adverse Interpretation of Other Agreements	 	32
	 	Section 10.12.	 	Successors	 	32
	 	Section 10.13.	 	Severability	 	32
	 	Section 10.14.	 	Table of Contents, Headings, Etc	 	32
	ARTICLE XI.    SINKING FUNDS	 	32
	 	Section 11.1.	 	Applicability of Article	 	32
	 	Section 11.2.	 	Satisfaction of Sinking Fund Payments with Securities	 	32
	 	Section 11.3.	 	Redemption of Securities for Sinking Fund	 	33
	ARTICLE XII.    SUBORDINATION OF SECURITIES	 	33
	 	Section 12.1.	 	Agreement of Subordination.	 	33
	 	Section 12.2.	 	Payments to Holders.	 	34
	 	Section 12.3.	 	Subrogation of Securities	 	36
	 	 	 	 	 

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	 	Section 12.4.	 	Authorization to Effect Subordination	 	36
	 	Section 12.5.	 	Notice to Trustee	 	37
	 	Section 12.6.	 	Trustee's Relation to Senior Indebtedness	 	37
	 	Section 12.7.	 	No Impairment of Subordination	 	38
	 	Section 12.8.	 	Article Applicable to Paying Agents	 	38
	 	Section 12.9.	 	Senior Indebtedness Entitled to Rely	 	38
	ARTICLE XIII.    GUARANTEES	 	38
	 	Section 13.1.	 	Unconditional Guarantee	 	38
	 	Section 13.2.	 	Limitation of Subsidiary Guarantor's Liability	 	39
	 	Section 13.3.	 	Contribution	 	39
	 	Section 13.4.	 	Execution and Delivery of Subsidiary Guarantees	 	39
	 	Section 13.5.	 	Addition of Subsidiary Guarantors	 	40
	 	Section 13.6.	 	Severability	 	40

iii

 
SUPERIOR ESSEX INC.  

Reconciliation
and tie between the Trust Indenture Act of 1939 and

Indenture, dated as of                            , 200    . 

	Section 310	 	(a)(1)	 	7.10
	 	 	(a)(2)	 	7.10
	 	 	(a)(3)	 	Not Applicable
	 	 	(a)(4)	 	Not Applicable
	 	 	(a)(5)	 	7.10
	 	 	(b)	 	7.10
	 	 	(c)	 	Not Applicable
	Section 311	 	(a)	 	7.11
	 	 	(b)	 	7.11
	 	 	(c)	 	Not Applicable
	Section 312	 	(a)	 	2.7
	 	 	(b)	 	10.3
	 	 	(c)	 	10.3
	Section 313	 	(a)	 	7.6
	 	 	(b)(1)	 	7.6
	 	 	(b)(2)	 	7.6
	 	 	(c)(1)	 	7.6
	 	 	(d)	 	7.6
	Section 314	 	(a)	 	4.2, 10.2, 10.5
	 	 	(b)	 	Not Applicable
	 	 	(c)(1)	 	10.4
	 	 	(c)(2)	 	10.4
	 	 	(c)(3)	 	Not Applicable
	 	 	(d)	 	Not Applicable
	 	 	(e)	 	10.5
	 	 	(f)	 	Not Applicable
	Section 315	 	(a)	 	7.1
	 	 	(b)	 	7.5
	 	 	(c)	 	7.1
	 	 	(d)	 	7.1
	 	 	(e)	 	6.14
	Section 316	 	(a)	 	2.10
	 	 	(a)(1)(A)	 	6.12
	 	 	(a)(1)(B)	 	6.13
	 	 	(a)(2)	 	Not Applicable
	 	 	(b)	 	6.8
	Section 317	 	(a)(1)	 	6.3
	 	 	(a)(2)	 	6.4
	 	 	(b)	 	2.6
	Section 318	 	(a)	 	10.1

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INDENTURE  

        Indenture dated as
of                            , 200            ,
between Superior Essex Inc., a Delaware corporation (the "Company"), and The Bank
of New York Trust Company, N.A., a national banking association ("Trustee"). 

WITNESSETH  

        WHEREAS, the Company has duly authorized the issuance, execution and delivery, from time to time, of its unsecured debentures, notes or other evidences of
indebtedness (hereinafter referred to as the "Securities"), without limit as to principal amount, issuable in one or more Series (as hereinafter defined), the amount and terms of each such Series to
be determined as hereinafter provided; and, to provide the terms and conditions upon which the Securities are to be authenticated, issued and delivered, the Company has duly authorized the execution
of this Indenture; 

        WHEREAS,
all things necessary to make this Indenture a valid indenture and agreement according to its terms have been done; 

        NOW,
THEREFORE: 

        In
consideration of the premises and the purchases of the Securities by the holders thereof, the Company and the Trustee mutually covenant and agree for the equal and proportionate
benefit of the respective holders from time to time of the Securities as follows: 

ARTICLE I.

DEFINITIONS AND INCORPORATION BY REFERENCE  

        Section 1.1.    Definitions. 

        "Additional
Amounts" means any additional amounts which are required hereby or by any Security, under circumstances specified herein or therein, to be paid by the Company in respect of
certain taxes imposed on Holders specified therein and which are owing to such Holders. 

        "Affiliate"
of any specified person means any other person directly or indirectly controlling or controlled by or under direct or indirect common control with such specified person. For
the purposes of this definition, "control" (including, with correlative meanings, the terms "controlled by" and "under common control with"), as used with respect to any person, shall mean the
possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such person, whether through the ownership of voting securities or by agreement or
otherwise. 

        "Agent"
means any Registrar, Paying Agent or Service Agent. 

        "Authorized
Newspaper" means a newspaper in an official language of the country of publication customarily published at least once a day for at least five days in each calendar week and
of general circulation in the place in connection with which the term is used. If it shall be impractical in the opinion of the Trustee to make any publication of any notice required hereby in an
Authorized Newspaper, any publication or other notice in lieu thereof that is made or given by the Trustee shall constitute a sufficient publication of such notice. 

        "Bearer"
means anyone in possession from time to time of a Bearer Security. 

        "Bearer
Security" means any Security, including any interest coupon appertaining thereto, that does not provide for the identification of the Holder thereof. 

        "Board
of Directors" means the Board of Directors of the Company or any duly authorized committee thereof. 

        "Board
Resolution" means a copy of a resolution certified by the Secretary or an Assistant Secretary of the Company to have been adopted by the Board of Directors or pursuant to
authorization by the Board of Directors and to be in full force and effect on the date of the certificate and delivered to the Trustee. 

 

        "Business
Day" means, unless otherwise provided by Board Resolution, Officers' Certificate or supplemental indenture hereto for a particular Series, any day except a Saturday, Sunday or
a legal holiday in the City of New York or Atlanta, Georgia on which banking institutions are authorized or required by law, regulation or executive order to close. 

        "Company"
means the party named as such above until a successor replaces it and thereafter means the successor. 

        "Company
Order" means a written order signed in the name of the Company by two Officers, one of whom must be the Company's chief executive officer, chief financial officer or principal
accounting officer. 

        "Company
Request" means a written request signed in the name of the Company by its Chairman of the Board, a President or a Vice President, and by either its Treasurer, an Assistant
Treasurer, its Secretary or an Assistant Secretary, and delivered to the Trustee. 

        "Corporate
Trust Office" means the office of the Trustee located in Atlanta, Georgia, or such other office as may be designated by the Trustee to the Company in writing. 

        "Debt"
of any person as of any date means, without duplication, all obligations of such person in respect of borrowed money, including all interest, fees and expenses owed in respect
thereto (whether or not the recourse of the lender is to the whole of the assets of such person or only to a portion thereof), or evidenced by bonds, notes, debentures or similar instruments. 

        "Default"
means any event which is, or after notice or passage of time would be, an Event of Default. 

        "Depository"
means, with respect to the Securities of any Series issuable or issued in whole or in part in the form of one or more Global Securities, the person designated as Depository
for such Series by the Company, which Depository shall be a clearing agency registered under the Exchange Act; and if at any time there is more than one such person, "Depository" as used with respect
to the Securities of any Series shall mean the Depository with respect to the Securities of such Series. 

        "Designated
Senior Indebtedness" means any of the Company's senior indebtedness that expressly provides that it is "designated senior indebtedness" for purposes of this Indenture
(provided that the instrument, agreement or other document creating or evidencing such Senior Indebtedness may place limitations and conditions on the right of such Senior Indebtedness to exercise the
rights of Designated Senior Indebtedness). 

        "Discount
Security" means any Security that provides for an amount less than the stated principal amount thereof to be due and payable upon declaration of acceleration of the maturity
thereof pursuant to Section 6.2. 

        "Dollars"
means the currency of the United States of America. 

        "Exchange
Act" means the Securities Exchange Act of 1934, as amended. 

        "Global
Security" or "Global Securities" means a Security or Securities, as the case may be, in the form established pursuant to Section 2.2 evidencing all or part of a Series of
Securities, issued to the Depository for such Series or its nominee, and registered in the name of such Depository or nominee. 

        "Holder"
or "Securityholder" means a person in whose name a Security is registered or the holder of a Bearer Security. 

        "Indenture"
means this Indenture as amended from time to time and shall include the form and terms of particular Series of Securities established as contemplated hereunder. 

        "interest"
with respect to any Discount Security which by its terms bears interest only after Maturity, means interest payable after Maturity. 

2

 

        "Maturity,"
when used with respect to any Security or installment of principal thereof, means the date on which the principal of such Security or such installment of principal becomes
due and payable as therein or herein provided, whether at the Stated Maturity or by declaration of acceleration, call for redemption, notice of option to elect repayment or otherwise. 

        "Officer"
means the Chairman of the Board, any President, any Vice-President, the Treasurer, the Secretary, any Assistant Treasurer or any Assistant Secretary of the Company. 

        "Officers'
Certificate" means a certificate signed by two Officers, one of whom must be the Company's principal executive officer, principal financial officer or principal accounting
officer. 

        "Opinion
of Counsel" means a written opinion of legal counsel who is acceptable to the Trustee. The counsel may be an employee of or counsel to the Company. 

        "person"
means any individual, corporation, partnership, joint venture, association, limited liability company, joint-stock company, trust, unincorporated organization or government or
any agency or political subdivision thereof. 

        "principal"
of a Security means the principal of the Security plus, when appropriate, the premium, if any, on, and any Additional Amounts in respect of, the Security. 

        "Representative"
means the (a) indenture trustee or other trustee, agent or representative for any Senior Indebtedness or (b) with respect to any Senior Indebtedness that
does not have any such trustee, agent or other representative, (i) in the case of such Senior Indebtedness issued pursuant to an agreement providing for voting arrangements as among the holders
or owners of such Senior Indebtedness, any holder or owner of such Senior Indebtedness acting with the consent of the required persons necessary to bind such holders or owners of such Senior
Indebtedness and (ii) in the case of all other such Senior Indebtedness, the holder or owner of such Senior Indebtedness. 

        "Responsible
Officer" means any officer of the Trustee in its Corporate Trust Office and also means, with respect to a particular corporate trust matter, any other officer to whom any
corporate trust matter is referred because of his or her knowledge of and familiarity with a particular subject. 

        "SEC"
means the Securities and Exchange Commission. 

        "Securities"
has the meaning given such item in the preamble hereto. 

        "Securities
Act" means the Securities Act of 1933, as amended. 

        "Senior
Indebtedness" means the principal, premium, if any, interest, including any interest accruing after bankruptcy, and other amounts due on any of our current or future Debt,
whether created, incurred, assumed, guaranteed or in effect guaranteed by us, including any deferrals, renewals, extensions, refundings, amendments, modifications or supplements to the above. However,
Senior Indebtedness does not include: (i) any Debt that expressly provides that it shall not be senior in right of
payment to the Securities or expressly provides that it is on the same basis or junior to the Securities; (ii) any Debt by us to any of our majority-owned subsidiaries; and (iii) the
Securities. 

        "Series"
or "Series of Securities" means each series of debentures, notes or other debt instruments of the Company created pursuant to Sections 2.1 and 2.2 hereof. 

        "Significant
Subsidiary" means (i) any direct or indirect Subsidiary of the Company that would be a "significant subsidiary" as defined in Article 1,
Rule 1-02 of Regulation S-X, promulgated pursuant to the Securities Act, as such regulation is in effect on the date hereof, or (ii) any group of direct or
indirect Subsidiaries of the Company that, taken together as a group, would be a "significant subsidiary" as defined in Article 1, Rule 1-02 of
Regulation S-X, promulgated pursuant to the Securities Act, as such regulation is in effect on the date hereof. 

3

 

        "Stated
Maturity," when used with respect to any Security or any installment of principal thereof or interest thereon, means the date specified in such Security as the fixed date on
which the principal of such Security or such installment of principal or interest is due and payable. 

        "Subsidiary"
of any specified person means any corporation of which at least a majority of the outstanding stock having by the terms thereof ordinary voting power for the election of
directors of such corporation (irrespective of whether or not at the time stock of any other class or classes of such corporation shall have or might have voting power by reason of the happening of
any contingency) is at the time directly or indirectly owned by such person, or by one or more other Subsidiaries, or by such person and one or more other Subsidiaries. 

        "Subsidiary
Guarantee" means a guarantee by any Subsidiary Guarantor of the Company's payment obligations under the Securities. 

        "Subsidiary
Guarantor" means (i) each Subsidiary of the Company executing this Indenture, (ii) each Subsidiary of the Company that executes a supplemental indenture and
becomes a guarantor of the Company's payment obligations under the Securities pursuant to Section 13.5, and (iii) any Subsidiary of the Company that is a successor corporation of any
Subsidiary of the Company referred to in clauses (i) and (ii). 

        "TIA"
means the Trust Indenture Act of 1939 (15 U.S. Code Sections 77aaa-77bbbb) as in effect on the date of this Indenture; provided, however, that in the event the Trust
Indenture Act of 1939 is amended after such date, "TIA" means, to the extent required by any such amendment, the Trust Indenture Act as so amended. 

        "Trustee"
means the person named as the "Trustee" in the first paragraph of this instrument until a successor Trustee shall have become such pursuant to the applicable provisions of this
Indenture, and thereafter "Trustee" shall mean or include each person who is then a Trustee hereunder, and if at any time there is more than one such person, "Trustee" as used with respect to the
Securities of any Series shall mean the Trustee with respect to Securities of that Series. 

        Section 1.2.    Definitions.

	TERM
 
	 	DEFINED IN

SECTION

	"Bankruptcy Law"	 	6.1
	"Custodian"	 	6.1
	"Government Obligations"	 	8.3
	"Legal Holiday"	 	10.7
	"mandatory sinking fund payment"	 	11.1
	"optional sinking fund payment"	 	11.1
	"Paying Agent"	 	2.5
	"Registrar"	 	2.5
	"Service Agent"	 	2.5
	"successor person"	 	5.1

        Section 1.3.    Incorporation
by Reference of Trust Indenture Act. 

        Whenever
this Indenture refers to a provision of the TIA, the provision is incorporated by reference in and made a part of this Indenture. The following TIA terms used in this Indenture
have the following meanings: 

        "Commission"
means the SEC. 

        "indenture
securities" means the Securities. 

        "indenture
security holder" means a Securityholder. 

4

 

        "indenture
to be qualified" means this Indenture. 

        "indenture
trustee" or "institutional trustee" means the Trustee. 

        "obligor"
on the indenture securities means the Company and any successor obligor upon the Securities. 

        All
other terms used in this Indenture that are defined by the TIA, defined by TIA reference to another statute or defined by SEC rule under the TIA and not otherwise defined herein are
used herein as so defined. 

        Section 1.4.    Rules
of Construction. 

        Unless
the context otherwise requires: 

         (a)  a
term has the meaning assigned to it; 

         (b)  an
accounting term not otherwise defined has the meaning assigned to it in accordance with generally accepted accounting principles; 

         (c)  "or"
is not exclusive; 

         (d)  words
in the singular include the plural, and in the plural include the singular; and 

         (e)  provisions
apply to successive events and transactions. 

ARTICLE II.

SECURITIES  

        Section 2.1.    Amount Unlimited; Issuable in Series. 

        The
aggregate principal amount of Securities that may be authenticated and delivered under this Indenture is unlimited. The Securities may be issued in one or more Series. All Securities
of a Series shall be identical except as may be set forth in a Board Resolution, a supplemental indenture or an Officers' Certificate detailing the adoption of the terms thereof pursuant to the
authority granted under a Board Resolution. In the case of Securities of a Series to be issued from time to time, the Board Resolution, Officers' Certificate or supplemental indenture may provide for
the method by which specified terms (such as interest rate, maturity date, record date or date from which interest shall accrue) are to be determined. Securities may differ between Series in respect
of any matters, provided that all Series of Securities shall be equally and ratably entitled to the benefits of the Indenture. 

        Section 2.2.    Establishment
of Terms of Series of Securities. 

        At
or prior to the issuance of any Securities within a Series, the following shall be established (as to the Series generally, in the case of subparagraph 2.2.1 and either as to such
Securities within the Series or as to the Series generally in the case of subparagraphs 2.2.2 through 2.2.22) by a Board Resolution, a supplemental indenture or an Officers' Certificate pursuant to
authority granted under a Board Resolution: 

        2.2.1.    the
title of the Series (which shall distinguish the Securities of that particular Series from the Securities of any other Series); 

        2.2.2.    any
limit upon the aggregate principal amount of the Securities of the Series which may be authenticated and delivered under this Indenture (except for Securities
authenticated and delivered upon registration of transfer of, or in exchange for, or in lieu of, other Securities of the Series pursuant to Section 2.8, 2.9, 2.10, 3.6 or 9.5); 

        2.2.3.    the
forms of the Securities of the Series in bearer or fully-registered form, whether any Securities of the Series may be represented initially by a Security in
temporary or permanent global form and, if so, the initial Depository with respect to any such temporary or permanent global Security and, as applicable, whether and the circumstances under which
beneficial owners of interests in any such temporary or permanent global Security may exchange such interests for Securities of such Series and of like tenor of any authorized form and denomination,
and any other terms required for the establishment of a Series of Securities in bearer form, including, but not limited to, tax compliance procedures; 

5

   
        2.2.4.    the price or prices (expressed as a percentage of the principal amount thereof) at which the Securities of the Series will be issued; 

        2.2.5.    the
person to whom any interest on any Security of the Series issued in fully-registered form shall be payable, if other than the person in whose name that Security
is registered at the close of business on the regular record date for such interest, and the manner in which, the person to whom, any interest on any Security of the Series issued in bearer form shall
be payable, if otherwise than upon presentation and surrender of the coupons appertaining thereto as they severally mature, and the extent to which, or the manner in which (including any certification
requirement and other terms and conditions under which), any interest payable on a temporary or permanent global Security on an interest payment date will be paid if other than as described herein; 

        2.2.6.    the
date or dates on which the principal of the Securities of the Series is payable or the method or methods, if any, used to determine those dates; 

        2.2.7.    the
rate or rates (which may be fixed or variable) per annum or, if applicable, the method used to determine such rate or rates (including, but not limited to, any
commodity, commodity index, stock exchange index or financial index) at which the Securities of the Series shall bear interest, if any, the date or dates from which such interest, if any, shall
accrue, the date or dates on which such interest, if any, shall commence and be payable and any regular record date for the interest payable on any interest payment date; 

        2.2.8.    the
place or places where and the manner in which the principal of and interest, if any, on the Securities of the Series shall be payable, any Securities of the
Series issued as Registered Securities may be surrendered for registration of transfer, Securities of the Series may be surrendered for exchange and notices and demands to or upon the Company in
respect of the Securities of the Series and this Indenture may be served; 

        2.2.9.    if
applicable, the period or periods within which, the price or prices at which and the terms and conditions upon which the Securities of the Series may be redeemed,
in whole or in part, at the option of the Company; 

        2.2.10.    the
obligation, if any, of the Company to redeem or purchase the Securities of the Series pursuant to any sinking fund or analogous provisions or at the option of a
Holder thereof, the
conditions, if any, giving rise to such obligation, and the period or periods within which, the price or prices at which and the terms and conditions upon which Securities of the Series shall be
redeemed or purchased, in whole or in part, pursuant to such obligation, and, if applicable, any provisions for the remarketing of such Securities; 

        2.2.11.    if
other than denominations of $1,000 and any integral multiple thereof, the denominations in which the Securities of the Series shall be issuable; 

        2.2.12.    the
currency or currencies, including composite currencies, in which payment of the principal of or interest on the Securities of the Series shall be payable if
other than the currency of the United States, and if so, whether the Securities of the Series may be satisfied and discharged other than as provided in Article VIII; 

        2.2.13    if
the amount of payments of principal of or interest on the Securities of the Series is to be determined with reference to an index, formula or other method, or
based on a coin or currency other than that in which the Securities of the Series are stated to be payable, the manner in which such amounts shall be determined and the calculation agent, if any, with
respect thereto; 

        2.2.14.    if
other than the principal amount thereof, the portion of the principal amount of the Securities of the Series that shall be payable upon declaration of
acceleration of the maturity thereof pursuant to Section 6.2; 

6

 

        2.2.15.    if
the Holders of Securities of the Series may convert or exchange the Securities into or for securities of the Company or other property, the period or periods
within which, the rate or rates at which and the terms and conditions upon which Securities of the Series may be converted or exchanged, in whole or in part; 

        2.2.16.    any
terms applicable to Discount Securities of the Series, if any, including the issue price thereof and the rate or rates at which the original issue discount will
accrue; 

        2.2.17.    whether
the Securities of the Series, in whole or any specified part, shall not be defeasible pursuant to Section 8.3 or Section 8.4 or both such
Sections and, if other than by an Officer's Certificate, the manner in which any election by the Company to defease such Securities shall be evidenced; 

        2.2.18.    the
provisions, if any, relating to any security provided for the Securities of the Series; 

        2.2.19.    any
addition to or change in the Events of Default which applies to any Securities of the Series and any change in the right of the Trustee or the requisite Holders
of such Securities to declare the principal amount thereof due and payable pursuant to Section 6.2; 

        2.2.20.    any
addition to or change in the covenants set forth in Articles IV or V which applies to Securities of the Series; 

        2.2.21.    any
other terms of the Securities of the Series (which terms shall not be inconsistent with the provisions of this Indenture, except as permitted by
Section 9.1, but which may modify or delete any provision of this Indenture insofar as it applies to such Series); and 

        2.2.22.    any
depositories, interest rate calculation agents, exchange rate calculation agents or other agents with respect to Securities of such Series if other than those
appointed herein. 

        All
Securities of any one Series need not be issued at the same time and may be issued from time to time, consistent with the terms of this Indenture, if so provided by or pursuant to
the Board Resolution, supplemental indenture or Officers' Certificate referred to above, and the authorized principal amount of any Series may not be increased to provide for issuances of additional
Securities of such Series, unless otherwise provided in such Board Resolution, supplemental indenture or Officers' Certificate. 

        Section 2.3.    Authentication
and Delivery of Securities. 

        At
any time and from time to time after the execution and delivery of this Indenture, the Company may deliver any Series of Securities executed by the Company to the Trustee for
authentication by it, and the Trustee shall thereupon authenticate and deliver said Securities to or upon a Company Order, without any further corporate action by the Company. If the form or terms of
such Series of Securities have been established in or pursuant to one or more Board Resolutions or a supplemental indenture as permitted by this Section 2.3 and Section 2.2, in
authenticating such Securities and accepting the additional responsibilities under this Indenture in relation to such Securities, the Trustee shall be entitled to receive, and (subject to
Section 7.1) shall be fully protected in relying upon: 

         (1)  each
Board Resolution relating to such Series of Securities; 

         (2)  an
executed supplemental indenture, if any, relating to such series of Securities; 

         (3)  an
Officers' Certificate setting forth the form and terms of the Securities, stating that the form and terms of the Securities have been established pursuant to
Section 2.2 and subparagraph 2.4.3 and comply with this Indenture, and covering such other matters as the Trustee may reasonably request; 

7

 

         (4)  an
Opinion of Counsel to the effect that: 

         (a)  if
the form of such Securities has been established by or pursuant to resolutions of the Board of Directors of the Company as permitted by subparagraph 2.4.3 that such
form has been established in conformity with the provisions of this Indenture; 

         (b)  if
the terms of such Securities have been established by or pursuant to Board Resolutions as permitted by Section 2.1, that such terms have been established in
conformity with the provisions of this Indenture; 

         (c)  that
such Securities, when authenticated and delivered by the Trustee and executed and issued by the Company in the manner and subject to any conditions specified in
such Opinion of Counsel, will be valid and binding obligations of the Company, except as any rights thereunder may be limited by bankruptcy, insolvency and other similar laws affecting the enforcement
of creditor's rights generally and by general equity principles; 

         (d)  that
all laws and requirements in respect of the execution and delivery by the Company of such Securities have been complied with and that authentication and delivery of
the Securities by the Trustee will not violate the terms of this Indenture; and 

         (e)  covering
such other matters as the Trustee may reasonably request. 

        Each
Registered Security shall be dated the date of its authentication. Any Series of Bearer Securities shall be dated as provided in the Board Resolution or the provisions of the
supplemental indenture creating such Series. 

        Section 2.4.    Execution
of Securities; Trustee's Certificate of Authentication; Form of Securities. 

        2.4.1.    Two
Officers shall sign the Securities for the Company by manual or facsimile signature. If an Officer whose signature is on a Security no longer holds that office at
the time the Security is authenticated, the Security shall nevertheless be valid. 

        2.4.2.    Only
such Securities bearing a certificate of authentication executed by the Trustee by the manual signature of one of its Responsible Officers, shall be entitled to
the benefits of this Indenture or be valid or obligatory for any purpose. Such certificate by the Trustee upon any Security executed by the Company shall be conclusive evidence that the Security so
authenticated has been duly authenticated and delivered hereunder and that the Holder is entitled to the benefits of this Indenture. 

        The
Trustee shall have the right to decline to authenticate and deliver any Securities of such Series: (a) if the Trustee, being advised by counsel, determines that such action
may not lawfully be taken; or (b) if the Trustee in good faith shall determine that such action would expose the Trustee to personal liability to Holders of any then outstanding Series of
Securities. 

        The
Trustee may appoint an authenticating agent acceptable to the Company to authenticate Securities. An authenticating agent may authenticate Securities whenever the Trustee may do so.
Each reference in this Indenture to authentication by the Trustee includes authentication by such agent. An authenticating agent has the same rights as an Agent to deal with the Company or an
Affiliate. 

        2.4.3.    The
Securities of each series shall be substantially of the tenor and purport as shall be authorized by a Board Resolution or in an indenture or indentures
supplemental hereto, in each case with such appropriate insertions, omissions, substitutions and other variations as are required or permitted by this Indenture, and may have such letters, numbers or
other marks of identification or designation and such legends or endorsements thereon as the Board of Directors of the Company may deem appropriate and as are not inconsistent with the provisions of
this Indenture, or as may be required to comply with any law or with any rule or regulation made pursuant thereto or with any rule or regulation of any stock exchange on which the Securities may be
listed, or to conform to usage. 

8

 

        The
definitive Securities may be printed, lithographed or fully or partly engraved or produced in any other manner, all as determined by the officers executing such Securities, as
evidenced by their executions thereof. 

        Section 2.5.    Registrar
and Paying Agent. 

        The
Company shall maintain, with respect to each Series of Securities, an office or agency where Securities of such Series may be presented or surrendered for payment ("Paying Agent"),
where Securities of such Series may be surrendered for registration of transfer or exchange ("Registrar") and where notices and demands to or upon the Company in respect of the Securities of such
Series and this Indenture may be served ("Service Agent"). The Registrar shall keep a register with respect to each Series of Securities and to their transfer and exchange. 

        The
Corporate Trust Office of the Trustee shall be such office or agency for all of the aforesaid purposes unless the Company shall maintain some other office or agency for such purposes
and The Company will give prompt written notice to the Trustee of the name and address, and any change in the name or address, of each Registrar, Paying Agent or Service Agent. If at any time the
Company shall fail to maintain any such required Registrar, Paying Agent or Service Agent or shall fail to furnish the Trustee with the name and address thereof, such presentations, surrenders,
notices and demands may be made or served at the Corporate Trust Office of the Trustee, and the Company hereby appoints the Trustee as its agent to receive all such presentations, surrenders, notices
and demands. 

        The
Company may also from time to time designate one or more co-registrars, additional paying agents or additional service agents and may from time to time rescind such
designations; provided, however, that no such designation or rescission shall in any manner relieve the Company of its obligations to maintain a Registrar, Paying Agent and Service Agent in each place
so specified pursuant to Section 2.2 for Securities of any Series for such purposes. The Company will give prompt written notice to the Trustee of any such designation or rescission and of any
change in the name or address of any such co-registrar, additional paying agent or additional service agent. The term "Registrar" includes any co-registrar; the term "Paying
Agent" includes any additional paying agent; and the term "Service Agent" includes any additional service agent. 

        The
Company hereby appoints the Trustee the initial Registrar, Paying Agent and Service Agent for each Series unless another Registrar, Paying Agent or Service Agent, as the case may be,
is appointed prior to the time Securities of that Series are first issued. 

        Section 2.6.    Paying
Agent to Hold Money in Trust. 

        The
Company shall require each Paying Agent other than the Trustee to agree in writing that the Paying Agent will hold in trust, for the benefit of Securityholders of any Series of
Securities, or the Trustee, all money held by the Paying Agent for the payment of principal of or interest on the Series of Securities, and will notify the Trustee of any default by the Company in
making any such payment. While any such default continues, the Trustee may require a Paying Agent to pay all money held by it to the Trustee. The Company at any time may require a Paying Agent to pay
all money held by it to the Trustee. Upon payment over to the Trustee, the Paying Agent (if other than the Company or a
Subsidiary) shall have no further liability for the money. If the Company or a Subsidiary acts as Paying Agent, it shall segregate and hold in a separate trust fund for the benefit of Securityholders
of any Series of Securities all money held by it as Paying Agent. 

        Section 2.7.    Securityholder
Lists. 

        The
Trustee shall preserve in as current a form as is reasonably practicable the most recent list available to it of the names and addresses of Securityholders of each Series of
Securities and shall otherwise comply with TIA Section 312(a). If the Trustee is not the Registrar, the Company shall furnish to the Trustee at least ten days before each interest payment date
and at such other times as 

9

 

the
Trustee may request in writing a list, in such form and as of such date as the Trustee may reasonably require, of the names and addresses of Securityholders of each Series of Securities. 

        Section 2.8.    Transfer
and Exchange. 

        Upon
surrender for registration of transfer of any Security at the office or agency of the Company designated for such purposes, the Company shall execute, and the Trustee shall
authenticate and deliver, in the name of the designated transferee or transferees, one or more new Securities of any authorized denomination or denominations of a like aggregate principal amount and
tenor. No service charge shall be made for any registration of transfer or exchange (except as otherwise expressly permitted herein), but the Company may require payment of a sum sufficient to cover
any transfer tax or similar governmental charge payable in connection therewith (other than any such transfer tax or similar governmental charge payable upon exchanges pursuant to Sections 2.12, 3.6
or 9.5). 

        At
the option of the Holder, Registered Securities of any Series may be exchanged for other Registered Securities of the same Series of any authorized denomination or denominations, of a
like aggregate principal amount and tenor, upon surrender of the Securities to be exchanged at such office or agency. Whenever any Securities are so surrendered for exchange, the Company shall
execute, and the Trustee shall authenticate and deliver, the Securities which the Holder making the exchange is entitled to receive. Bearer Securities may not be issued in exchange for Registered
Securities. 

        All
Securities issued upon any registration of transfer or exchange of Securities shall be the valid obligations of the Company, evidencing the same debt, and entitled to the same
benefits under this Indenture, as the Securities surrendered upon such registration of transfer or exchange. 

        Every
Registered Security presented or surrendered for registration of transfer or exchange shall be duly endorsed, or be accompanied by a written instrument of transfer in form
satisfactory to the Company and the Registrar duly executed, by the Holder thereof or his attorney duly authorized in writing. 

        Neither
the Company nor the Registrar shall be required (a) to issue, register the transfer of, or exchange Securities of any Series for the period beginning at the opening of
business 15 days immediately preceding the mailing of a notice of redemption of Securities of that Series selected for redemption and ending at the close of business on the day of such mailing,
or (b) to register the transfer of or exchange Securities of any Series selected, called or being called for redemption as a whole or the portion being redeemed of any such Securities selected,
called or being called for redemption in part. 

        Section 2.9.    Mutilated,
Destroyed, Lost and Stolen Securities. 

        If
any mutilated Security is surrendered to the Trustee, the Company shall execute and the Trustee shall authenticate and deliver in exchange therefor a new Security of the same Series
and of like tenor and principal amount and bearing a number not contemporaneously outstanding. 

        If
there shall be delivered to the Company and the Trustee (i) evidence to their satisfaction of the destruction, loss or theft of any Security and (ii) such security or
indemnity as may be required by them to save each of them and any agent of either of them harmless, then, in the absence of notice to the Company or the Trustee that such Security has been acquired by
a bona fide purchaser, the Company shall execute and upon its request the Trustee shall authenticate and make available for delivery, in lieu of any such destroyed, lost or stolen Security, a new
Security of the same Series and of like tenor and principal amount and bearing a number not contemporaneously outstanding. 

        In
case any such mutilated, destroyed, lost or stolen Security has become or is about to become due and payable, the Company in its discretion may, instead of issuing a new Security, pay
such Security. 

10

 

        Upon
the issuance of any new Security under this Section 2.9, the Company may require the payment of a sum sufficient to cover any tax or other governmental charge that may be
imposed in relation thereto and any other expenses (including the fees and expenses of the Trustee) connected therewith. 

        Every
new Security of any Series issued pursuant to this Section in lieu of any destroyed, lost or stolen Security shall constitute an original additional contractual obligation of the
Company, whether or not the destroyed, lost or stolen Security shall be at any time enforceable by anyone, and shall be entitled to all the benefits of this Indenture equally and proportionately with
any and all other Securities of that Series duly issued hereunder. 

        The
provisions of this Section are exclusive and shall preclude (to the extent lawful) all other rights and remedies with respect to the replacement or payment of mutilated, destroyed,
lost or stolen Securities. 

        Section 2.10.    Outstanding
Securities. 

        The
Securities outstanding at any time are all the Securities authenticated by the Trustee except for those canceled by it, those delivered to it for cancellation, those reductions in
the interest on a Global Security effected by the Trustee in accordance with the provisions hereof and those described in this Section as not outstanding. 

        If
a Security is replaced pursuant to Section 2.9, it ceases to be outstanding until the Trustee receives proof satisfactory to it that the replaced Security is held by a bona
fide purchaser. 

        If
the Paying Agent (other than the Company, a Subsidiary or an Affiliate of any thereof) holds on the Maturity of Securities of a Series money sufficient to pay such Securities payable
on that date, then on and after that date such Securities of the Series cease to be outstanding and interest on them ceases to accrue. 

        A
Security does not cease to be outstanding because the Company or an Affiliate holds the Security. 

        In
determining whether the Holders of the requisite principal amount of outstanding Securities have given any request, demand, authorization, direction, notice, consent or waiver
hereunder, the principal amount of a Discount Security that shall be deemed to be outstanding for such purposes shall be the amount of the principal thereof that would be due and payable as of the
date of such determination upon a declaration of acceleration of the Maturity thereof pursuant to Section 6.2. 

        Section 2.11.    Treasury
Securities. 

        In
determining whether the Holders of the required principal amount of Securities of a Series have concurred in any request, demand, authorization, direction, notice, consent or waiver,
Securities of a
Series owned by the Company or an Affiliate shall be disregarded, except that for the purposes of determining whether the Trustee shall be protected in relying on any such request, demand,
authorization, direction, notice, consent or waiver only Securities of a Series that the Trustee knows are so owned shall be so disregarded. 

        Section 2.12.    Temporary
Securities. 

        Until
definitive Securities are ready for delivery, the Company may prepare and the Trustee shall authenticate temporary Securities upon a Company Order. Temporary Securities shall be
substantially in the form of definitive Securities but may have variations that the Company considers appropriate for temporary Securities. Without unreasonable delay, the Company shall prepare and
the Trustee upon request shall authenticate definitive Securities of the same Series and date of maturity in exchange for temporary Securities. Until so exchanged, temporary Securities shall have the
same rights under this Indenture as the definitive Securities. 

11

   
        Section 2.13.    Cancellation. 

        The
Company at any time may deliver Securities to the Trustee for cancellation. The Registrar and the Paying Agent shall forward to the Trustee any Securities surrendered to them for
registration of transfer, exchange or payment. The Trustee shall cancel all Securities surrendered for transfer, exchange, payment, replacement or cancellation and shall destroy such canceled
Securities (subject to the record retention requirement of the Exchange Act) and deliver a certificate of such destruction to the Company, unless the Company otherwise directs. The Company may not
issue new Securities to replace Securities that it has paid or delivered to the Trustee for cancellation. 

        Section 2.14.    Defaulted
Interest. 

        Unless
the terms of a Series of Securities adopted pursuant to Section 2.2 shall provide otherwise, if the Company defaults in a payment of interest on a Series of Securities, it
shall pay the defaulted interest, plus, to the extent permitted by law, any interest payable on the defaulted interest, to the persons who are Securityholders of the Series on a subsequent special
record date. The Company shall fix the record date and payment date. At least 30 days before the record date, the Company shall mail to the Trustee and to each Securityholder of the
Series a notice that states the record date, the payment date and the amount of interest to be paid. The Company may pay defaulted interest in any other lawful manner. 

        Section 2.15.    Global
Securities. 

        2.15.1.    Terms
of Securities. A Board Resolution, a supplemental indenture hereto or an Officers' Certificate shall establish whether the Securities of a Series shall be
issued in whole or in part in the form of one or more Global Securities and the Depository for such Global Security or Securities. 

        2.15.2.    Transfer
and Exchange. Notwithstanding any provisions to the contrary contained in Section 2.8 of the Indenture and in addition thereto, any Global Security
shall be exchangeable pursuant to Section 2.8 of the Indenture for Securities registered in the names of Holders other than the Depository for such Security or its nominee only if
(i) such Depository notifies the Company that it is unwilling or unable to continue as Depository for such Global Security or if at any time such Depository ceases to be a clearing agency
registered under the Exchange Act, and, in either case, the Company fails to appoint a successor Depository within 90 days of such event, (ii) the Company executes and delivers to the
Trustee an Officers' Certificate to the effect that such Global Security shall be so exchangeable or (iii) an Event
of Default with respect to the Securities represented by such Global Security shall have happened and be continuing. Any Global Security that is exchangeable pursuant to the preceding sentence shall
be exchangeable for Securities registered in such names as the Depository shall direct in writing in an aggregate principal amount equal to the principal amount of the Global Security with like tenor
and terms. 

        Except
as provided in this Section 2.15.2, a Global Security may not be transferred except as a whole by the Depository with respect to such Global Security to a nominee of such
Depository, by a nominee of such Depository to such Depository or another nominee of such Depository or by the Depository or any such nominee to a successor Depository or a nominee of such a successor
Depository. 

        2.15.3.    Legend.
Any Global Security issued hereunder shall bear a legend in substantially the following form: 

        "This
Security is a Global Security within the meaning of the Indenture hereinafter referred to and is registered in the name of the Depository or a nominee of the Depository. This
Security is exchangeable for Securities registered in the name of a person other than the Depository or its nominee only in the limited circumstances described in the Indenture, and may not be
transferred except as a whole by the Depository to a nominee of the Depository, by a nominee of the Depository 

12

 

to
the Depository or another nominee of the Depository or by the Depository or any such nominee to a successor Depository or a nominee of such a successor Depository." 

        2.15.4.    Acts
of Holders. The Depository, as a Holder, may appoint agents and otherwise authorize participants to give or take any request, demand, authorization, direction,
notice, consent, waiver or other action which a Holder is entitled to give or take under the Indenture. 

        2.15.5.    Payments.
Notwithstanding the other provisions of this Indenture, unless otherwise specified as contemplated by Section 2.2, payment of the principal of and
interest, if any, on any Global Security shall be made to the Holder thereof. 

        2.15.6.    Consents,
Declaration and Directions. Except as provided in subparagraph 2.15.5, the Company, the Trustee and any Agent shall treat a person as the Holder of such
principal amount of outstanding Securities of such Series represented by a Global Security as shall be specified in a written statement of the Depository with respect to such Global Security, for
purposes of obtaining any consents, declarations, waivers or directions required to be given by the Holders pursuant to this Indenture. 

        Section 2.16.    CUSIP
Numbers. 

        The
Company in issuing the Securities may use "CUSIP" numbers (if then generally in use), and, if so, the Trustee shall use "CUSIP" numbers in notices of redemption as a convenience to
Holders; provided that any such notice may state that no representation is made as to the correctness of such numbers either as printed on the Securities or as contained in any notice of a redemption
and that reliance may be placed only on the other elements of identification printed on the Securities, and any such redemption shall not be affected by any defect in or omission of such numbers. 

ARTICLE III.

REDEMPTION  

        Section 3.1.    Notice to Trustee. 

        The
Company may, with respect to any Series of Securities, reserve the right to redeem and pay the Series of Securities or may covenant to redeem and pay the Series of Securities or any
part thereof prior to the Stated Maturity thereof at such time and on such terms as provided for in such Securities. If a Series of Securities is redeemable and the Company wants or is obligated to
redeem prior to the Stated Maturity thereof all or part of the Series of Securities pursuant to the terms of such Securities, it shall notify the Trustee of the redemption date and the principal
amount of Series of Securities to be redeemed. The Company shall give the notice at least 45 days before the redemption date (or such shorter notice as may be acceptable to the Trustee). 

        Section 3.2.    Selection
of Securities to be Redeemed. 

        Unless
otherwise indicated for a particular Series by a Board Resolution, a supplemental indenture or an Officers' Certificate, if less than all the Securities of a Series are to be
redeemed, the Trustee shall select the Securities of the Series to be redeemed by lot or in any other manner that the Trustee deems fair and appropriate. The Trustee shall make the selection from
Securities of the Series outstanding not previously called for redemption. The Trustee may select for redemption portions of the principal of Securities of the Series that have denominations larger
than $1,000. Securities of the Series and portions of them it selects shall be in amounts of $1,000 or whole multiples of $1,000 or, with respect to Securities of any Series issuable in other
denominations pursuant to Section 2.2.11, the minimum principal denomination for each Series and integral multiples thereof. Provisions of this Indenture that apply to Securities of a Series
called for redemption also apply to portions of Securities of that Series called for redemption. 

13

 

        Section 3.3.    Notice
of Redemption. 

        Unless
otherwise indicated for a particular Series by Board Resolution, a supplemental indenture hereto or an Officers' Certificate, at least 30 days but not more than
60 days before a redemption date, the Company shall mail a notice of redemption by first-class mail to each Holder whose Securities are to be redeemed and if any Bearer Securities are
outstanding, publish on one occasion a notice in an Authorized Newspaper. 

        The
notice shall identify the Securities of the Series to be redeemed and shall state: 

         (a)  the
redemption date; 

         (b)  the
redemption price; 

         (c)  the
name and address of the Paying Agent; 

         (d)  that
Securities of the Series called for redemption must be surrendered to the Paying Agent to collect the redemption price; 

         (e)  that
interest on Securities of the Series called for redemption ceases to accrue on and after the redemption date; and 

          (f)  any
other information as may be required by the terms of the particular Series or the Securities of a Series being redeemed. 

        At
the Company's request, the Trustee shall give the notice of redemption in the Company's name and at its expense. 

        Section 3.4.    Effect
of Notice of Redemption. 

        Once
notice of redemption is mailed or published as provided in Section 3.3, Securities of a Series called for redemption become due and payable on the redemption date and at the
redemption price. A notice of redemption may not be conditional. Upon surrender to the Paying Agent, such Securities shall be paid at the redemption price plus accrued interest to the redemption date. 

        Section 3.5.    Deposit
of Redemption Price. 

        On
or before the redemption date, the Company shall deposit with the Paying Agent money sufficient to pay the redemption price of and accrued interest, if any, on all Securities to be
redeemed on that date. 

        Section 3.6.    Securities
Redeemed in Part. 

        Upon
surrender of a Security that is redeemed in part, the Trustee shall authenticate for the Holder a new Security of the same Series and the same maturity equal in principal amount to
the unredeemed portion of the Security surrendered. 

ARTICLE IV.

COVENANTS  

        Section 4.1.    Payment of Principal and Interest. 

        The
Company covenants and agrees for the benefit of the Holders of each Series of Securities that it will duly and punctually pay the principal of and interest, if any, on the Securities
of that Series in accordance with the terms of such Securities and this Indenture. 

        Section 4.2.    SEC
Reports. 

        The
Company shall deliver to the Trustee within 15 days after it files them with the SEC, copies of the annual reports and of the information, documents, and other reports (or
copies of such portions of 

14

 

any
of the foregoing as the SEC may by rules and regulations prescribe) which the Company is required to file with the SEC pursuant to Section 13 or 15(d) of the Exchange Act. The Company also
shall comply with the other provisions of TIA Section 314(a). 

        Section 4.3.    Compliance
Certificate. 

        The
Company shall deliver to the Trustee, within 120 days after the end of each fiscal year of the Company, an Officers' Certificate stating that a review of the activities of the
Company and its Subsidiaries during the preceding fiscal year has been made under the supervision of the signing Officers with a view to determining whether the Company has kept, observed, performed
and fulfilled its obligations under this Indenture, and further stating, as to each such Officer signing such certificate, that to the best of his knowledge the Company has kept, observed, performed
and fulfilled each and every covenant contained in this Indenture and is not in default in the performance or observance of any of the terms, provisions and conditions hereof (or, if a Default or
Event of Default shall have occurred, describing all such Defaults or Events of Default of which he may have knowledge). 

        The
Company will, so long as any of the Securities are outstanding, deliver to the Trustee, forthwith upon becoming aware of any Default or Event of Default, an Officers' Certificate
specifying such Default or Event of Default and what action the Company is taking or proposes to take with respect thereto. 

        Section 4.4.    Stay,
Extension and Usury Laws. 

        The
Company covenants (to the extent that it may lawfully do so) that it will not at any time insist upon, plead, or in any manner whatsoever claim or take the benefit or advantage of,
any stay, extension or usury law wherever enacted, now or at any time hereafter in force, which may affect the covenants or the performance of this Indenture or the Securities; and the Company (to the
extent it may lawfully do so) hereby expressly waives all benefit or advantage of any such law and covenants that it will not, by resort to any such law, hinder, delay or impede the execution of any
power herein granted to the Trustee, but will suffer and permit the execution of every such power as though no such law has been enacted. 

        Section 4.5.    Corporate
Existence. 

        Subject
to Article V, the Company will do or cause to be done all things necessary to preserve and keep in full force and effect its corporate existence and the corporate,
partnership or other existence of each Significant Subsidiary in accordance with the respective organizational documents of each Significant Subsidiary and the rights (charter and statutory), licenses
and franchises of the Company and its Significant Subsidiaries; provided, however, that the Company shall not be required to preserve any such right, license or franchise, or the corporate,
partnership or other existence of any Significant Subsidiary, if the Board of Directors shall determine that the preservation thereof is no longer desirable in the conduct of the business of the
Company and its Subsidiaries taken as a whole and that the loss thereof is not adverse in any material respect to the Holders. 

ARTICLE V.

SUCCESSORS  

        Section 5.1.    When Company May Merge, Etc. 

        The
Company shall not consolidate with or merge with or into any other person or convey, transfer or lease its properties and assets substantially as an entirety to any person, unless: 

         (a)  either
(1) the Company shall be the continuing corporation or (2) the person (if other than the Company) formed by such consolidation or into which the
Company is merged or the person which acquires by conveyance, transfer or lease the properties and assets of the Company substantially as an entirety (i) shall be a corporation, partnership,
limited liability company, trust or other entity organized 

15

 

and
validly existing under the laws of the United States or any state thereof or the District of Columbia and (ii) shall expressly assume, by an indenture supplemental hereto, executed and
delivered to the Trustee, in form satisfactory to the Trustee, all of the obligations of the Company under the Securities and this Indenture; 

         (b)  immediately
after giving effect to the transaction, no Default or Event of Default shall have occurred and be continuing; and 

         (c)  the
Company shall have delivered to the Trustee an Officer's Certificate and an Opinion of Counsel, each stating that such consolidation, merger, conveyance, transfer or
lease and, if a supplemental indenture is required in connection with such transaction, such supplemental indenture, comply with this Article and that all conditions precedent herein provided for
relating to such transaction have been satisfied. 

        Section 5.2.    Successor
Corporation Substituted. 

        Upon
any consolidation or merger, or any sale, lease, conveyance or other disposition of the properties and assets substantially as an entirety of the Company in accordance with
Section 5.1, the successor person formed by any such consolidation or into which the Company is merged or the successor person to which such conveyance, transfer or lease is made shall succeed
to, and be substituted for, and may exercise every right and power of the Company under this Indenture with the same effect as if such successor had been named as the Company herein; and thereafter,
except in the case of a lease of its properties and assets substantially as an entirety, the Company shall be discharged from all obligations and covenants under this Indenture and the Securities. 

ARTICLE VI.

DEFAULTS AND REMEDIES  

        Section 6.1.    Events of Default. 

        "Event
of Default," whenever used herein with respect to Securities of any Series, means any one of the following events, unless in the establishing Board Resolution, supplemental
indenture or Officers' Certificate it is provided that such Series shall not have the benefit of said Event of Default: 

         (a)  the
Company defaults in (i) the payment of the principal of any Security of such Series at its Maturity or (ii) the payment of any interest on any Security
of that Series when it becomes due and payable, and continuance of such default for a period of 30 days (unless the entire amount of such payment is deposited by the Company with the Trustee or
with a Paying Agent prior to the expiration of such period of 30 days); 

         (b)  the
Company fails to comply with any of its agreements in the Securities or this Indenture (other than those referred to in clause (a) above and other than a
covenant or warranty a default in whose performance or whose breach is elsewhere in this Section specifically deal with or which has been expressly included in this Indenture solely for the benefit of
a Series of Securities other than such Series) and such failure continues for 60 days after there has been given, by registered or certified mail, to the Company by the Trustee or to the
Company and the Trustee by the Holders of at least 25% in principal amount of the outstanding Securities of that Series a written notice specifying such default or breach and requiring it to be
remedied and stating that such notice is a "Notice of Default" hereunder; 

         (c)  the
Company pursuant to or within the meaning of any Bankruptcy Law: 

          (i)  commences
a voluntary case, 

         (ii)  consents
to the entry of an order for relief against it in an involuntary case, 

        (iii)  consents
to the appointment of a Custodian of it or for all or substantially all of its property, 

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        (iv)  makes
a general assignment for the benefit of its creditors, or 

         (v)  generally
is unable to pay its debts as the same become due; or 

         (d)  a
court of competent jurisdiction enters an order or decree under any Bankruptcy Law that: 

          (i)  is
for relief against the Company in an involuntary case, 

         (ii)  appoints
a Custodian of the Company for all or substantially all of its property, or 

        (iii)  orders
the liquidation of the Company or any of its Significant Subsidiaries, and the order or decree remains unstayed and in effect for 60 days; or 

         (e)  any
other Event of Default provided with respect to Securities of that Series, which is specified in a Board Resolution, a supplemental indenture hereto or an Officers'
Certificate, in accordance with Section 2.2 hereof. 

        The
term "Bankruptcy Law" means Title 11, U.S. Code or any similar Federal or state law for the relief of debtors. The term "Custodian" means any receiver, trustee, assignee, liquidator
or similar official under any Bankruptcy Law. 

        Section 6.2.    Acceleration
of Maturity; Rescission and Annulment. 

        If
an Event of Default with respect to Securities of any Series at the time outstanding occurs and is continuing (other than an Event of Default referred to in Section 6.1(c) or
(d)) then in every such case the Trustee or the Holders of not less than 25% in principal amount of the outstanding Securities of that Series may declare the principal amount (or, if any Securities of
that Series are Discount Securities, such portion of the principal amount as may be specified in the terms of such Securities) of and accrued and unpaid interest, if any, on all of the Securities of
that Series to be due and payable immediately, by a notice in writing to the Company (and to the Trustee if given by Holders), and upon any such declaration such principal amount (or specified amount)
and accrued and unpaid interest, if any, shall become immediately due and payable. If an Event of Default specified in Section 6.1(c) or (d) shall occur, the principal amount (or
specified amount) of and accrued and unpaid interest, if any, on all outstanding Securities shall ipso facto become and be immediately due and payable without any declaration or other act on the part
of the Trustee or any Holder. 

        At
any time after such a declaration of acceleration with respect to any Series has been made and before a judgment or decree for payment of the money due has been obtained by the
Trustee as hereinafter in this Article VI provided, the Holders of a majority in principal amount of the outstanding Securities of that Series, by written notice to the Company and the Trustee,
may rescind and annul such declaration and its consequences if: 

         (a)  the
Company has paid or deposited with the Trustee a sum sufficient to pay: 

          (i)  all
overdue interest, if any, on all Securities of that Series, 

         (ii)  the
principal of any Securities of that Series which have become due otherwise than by such declaration of acceleration and interest thereon at the rate or rates
prescribed therefor in such Securities, 

        (iii)  to
the extent that payment of such interest is lawful, interest upon any overdue principal and overdue interest at the rate or rates prescribed therefor in such
Securities, and 

        (iv)  all
sums paid or advanced by the Trustee hereunder and the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel; and 

         (b)  all
Events of Default with respect to Securities of that Series, other than the non-payment of the principal of Securities of that Series which have become
due solely by such declaration of acceleration, have been cured or waived as provided in Section 6.13. 

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        No
such rescission shall affect any subsequent Default or impair any right consequent thereon. 

        Section 6.3.    Collection
of Indebtedness and Suits for Enforcement by Trustee. 

        The
Company covenants that if 

         (a)  default
is made in the payment of any interest on any Security when such interest becomes due and payable and such default continues for a period of 30 days, or 

         (b)  default
is made in the payment of principal of any Security at the Maturity thereof, or 

         (c)  default
is made in the deposit of any sinking fund payment when and as due by the terms of a Security, 

then,
the Company will, upon demand of the Trustee, pay to it, for the benefit of the Holders of such Securities, the whole amount then due and payable on such Securities for principal and interest
and, to the extent that payment of such interest shall be legally enforceable, interest on any overdue principal or any overdue interest, at the rate or rates prescribed therefor in such Securities,
and, in addition thereto, such further amount as shall be sufficient to cover the costs and expenses of collection, including the reasonable compensation, expenses, disbursements and advances of the
Trustee, its agents and counsel. 

        If
the Company fails to pay such amounts forthwith upon such demand, the Trustee, in its own name and as trustee of an express trust, may institute a judicial proceeding for the
collection of the sums so due and unpaid, may prosecute such proceeding to judgment or final decree and may enforce the same against the Company or any other obligor upon such Securities and collect
the moneys adjudged or deemed to be payable in the manner provided by law out of the property of the Company or any other obligor upon such Securities, wherever situated. 

        If
an Event of Default with respect to any Securities of any Series occurs and is continuing, the Trustee may in its discretion proceed to protect and enforce its rights and the rights
of the Holders of Securities of such Series by such appropriate judicial proceedings as the Trustee shall deem most effectual to protect and enforce any such rights, whether for the specific
enforcement of any covenant or agreement in this Indenture or in aid of the exercise of any power granted herein, or to enforce any other proper remedy. 

        Section 6.4.    Trustee
May File Proofs of Claim. 

        In
case of the pendency of any receivership, insolvency, liquidation, bankruptcy, reorganization, arrangement, adjustment, composition or other judicial proceeding relative to the
Company or any other obligor upon the Securities or the property of the Company or of such other obligor or their creditors, the Trustee (irrespective of whether the principal of the Securities shall
then be due and payable as therein expressed or by declaration or otherwise and irrespective of whether the Trustee shall have made any demand on the Company for the payment of overdue principal or
interest) shall be entitled and empowered, by intervention in such proceeding or otherwise, 

         (a)  to
file and prove a claim for the whole amount of principal and interest owing and unpaid in respect of the Securities and to file such other papers or documents as may
be necessary or advisable in order to have the claims of the Trustee (including any claim for the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel)
and of the Holders allowed in such judicial proceeding, and 

         (b)  to
collect and receive any moneys or other property payable or deliverable on any such claims and to distribute the same, and any custodian, receiver, assignee, trustee,
liquidator, sequestrator or other similar official in any such judicial proceeding is hereby authorized by each Holder to make such payments to the Trustee and, in the event that the Trustee shall
consent to the making of such payments directly to the Holders, to pay to the Trustee any amount due it for the reasonable 

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compensation,
expenses, disbursements and advances of the Trustee, its agents and counsel, and any other amounts due the Trustee under Section 7.7. 

        Nothing
herein contained shall be deemed to authorize the Trustee to authorize or consent to or accept or adopt on behalf of any Holder any plan of reorganization, arrangement,
adjustment or composition affecting the Securities or the rights of any Holder thereof or to authorize the Trustee to vote in respect of the claim of any Holder in any such proceeding. 

        Section 6.5.    Trustee
May Enforce Claims Without Possession of Securities. 

        All
rights of action and claims under this Indenture or the Securities may be prosecuted and enforced by the Trustee without the possession of any of the Securities or the production
thereof in any proceeding relating thereto, and any such proceeding instituted by the Trustee shall be brought in its own name as trustee of an express trust, and any recovery of judgment shall, after
provision for the payment of the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel, be for the ratable benefit of the Holders of the Securities in
respect of which such judgment has been recovered. 

        Section 6.6.    Application
of Money Collected. 

        Any
money collected by the Trustee pursuant to this Article VI shall be applied in the following order, at the date or dates fixed by the Trustee and, in case of the distribution
of such money on account of principal or interest, upon presentation of the Securities and the notation thereon of the payment if only partially paid and upon surrender thereof if fully paid: 

        First:
To the payment of all amounts due the Trustee under Section 7.7; and 

        Second:
To the payment of the amounts then due and unpaid for principal of and interest on the Securities in respect of which or for the benefit of which such money has been collected,
ratably, without preference or priority of any kind, according to the amounts due and payable on such Securities for principal and interest, respectively; and 

        Third:
To the Company. 

        Section 6.7.    Limitation
on Suits. 

        No
Holder of any Security of any Series shall have any right to institute any proceeding, judicial or otherwise, with respect to this Indenture, or for the appointment of a receiver or
trustee, or for any other remedy hereunder, unless 

         (a)  such
Holder has previously given written notice to the Trustee of a continuing Event of Default with respect to the Securities of that Series; 

         (b)  the
Holders of not less than 25% in principal amount of the outstanding Securities of that Series shall have made written request to the Trustee to institute proceedings
in respect of such Event of Default in its own name as Trustee hereunder; 

         (c)  such
Holder or Holders have offered to the Trustee reasonable indemnity against the costs, expenses and liabilities to be incurred in compliance with such request; 

         (d)  the
Trustee for 60 days after its receipt of such notice, request and offer of indemnity has failed to institute any such proceeding; and 

         (e)  no
direction inconsistent with such written request has been given to the Trustee during such 60-day period by the Holders of a majority in principal amount
of the outstanding Securities of that Series; 

it
being understood and intended that no one or more of such Holders shall have any right in any manner whatever by virtue of, or by availing of, any provision of this Indenture to affect, disturb or 

19

 

prejudice
the rights of any other of such Holders, or to obtain or to seek to obtain priority or preference over any other of such Holders or to enforce any right under this Indenture, except in the
manner herein provided and for the equal and ratable benefit of all such Holders. 

        Section 6.8.    Unconditional
Right of Holders to Receive Principal and Interest. 

        Notwithstanding
any other provision in this Indenture, the right, which is absolute and unconditional, of any Holder of any Security to receive payment of the principal of and interest
on such Security on the Stated Maturity or Maturities expressed in such Security (or in the case of redemption, on the redemption date) held by such Holder, on or after the respective due dates
expressed in the Securities or any redemption date, or to bring suit for the enforcement of any such payment on or after the respective dates, shall not be impaired or affected adversely without the
consent of each such Holder. 

        Section 6.9.    Restoration
of Rights and Remedies. 

        If
the Trustee or any Holder has instituted any proceeding to enforce any right or remedy under this Indenture and such proceeding has been discontinued or abandoned for any reason, or
has been determined adversely to the Trustee or to such Holder, then and in every such case, subject to any determination in such proceeding, the Company, the Trustee and the Holders shall be restored
severally and respectively to their former positions hereunder and thereafter all rights and remedies of the Trustee and the Holders shall continue as though no such proceeding had been instituted. 

        Section 6.10.    Rights
and Remedies Cumulative. 

        Except
as otherwise provided with respect to the replacement or payment of mutilated, destroyed, lost or stolen Securities in Section 2.9, no right or remedy herein conferred upon
or reserved to the Trustee or to the Holders is intended to be exclusive of any other right or remedy, and every right and remedy shall, to the extent permitted by law, be cumulative and in addition
to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not
prevent the concurrent assertion or employment of any other appropriate right or remedy. 

        Section 6.11.    Delay
or Omission Not Waiver. 

        No
delay or omission of the Trustee or of any Holder of any Securities to exercise any right or remedy accruing upon any Event of Default shall impair any such right or remedy or
constitute a waiver of any such Event of Default or an acquiescence therein. Every right and remedy given by this Article VI or by law to the Trustee or to the Holders may be exercised from
time to time, and as often as may be deemed expedient, by the Trustee or by the Holders, as the case may be. 

        Section 6.12.    Control
by Holders. 

        The
Holders of a majority in principal amount of the outstanding Securities of any Series shall have the right to direct the time, method and place of conducting any proceeding for any
remedy available to the Trustee, or exercising any trust or power conferred on the Trustee, with respect to the Securities of such Series. However, the Trustee may refuse to follow any direction that
conflicts with law or this Indenture or that the Trustee determines in good faith is unduly prejudicial to the rights of other Holders or would involve the Trustee in personal liability. 

        Section 6.13.    Waiver
of Past Defaults. 

        The
Holders of a majority in aggregate principal amount of the outstanding Securities of any Series, by notice to the Trustee (and without notice to any other Holder), may on behalf of
the Holders of all of the Securities of such Series waive an existing Default with respect to such Series and its consequences except that the consent of the Holders of 100% of the Securities of such
Series shall be required to waive (a) an Event of Default described in Section 6.1(a) with respect to such Series or 

20

 

(b) a
Default in respect of a provision that under Section 9.2 cannot be amended without the consent of the Holder of each outstanding Security of the Series affected. When a Default is
waived, it is deemed cured, but no such waiver shall extend to any subsequent or other Default or impair any consequent right. 

        Section 6.14.    Undertaking
for Costs. 

        All
parties to this Indenture agree, and each Holder of any Security by his acceptance thereof shall be deemed to have agreed, that any court may in its discretion require, in any suit
for the enforcement of any right or remedy under this Indenture, or in any suit against the Trustee for any action taken, suffered or omitted by it as Trustee, the filing by any party litigant in such
suit of an undertaking to pay the costs of such suit, and that such court may in its discretion assess reasonable costs, including reasonable attorneys' fees, against any party litigant in such suit,
having due regard to the merits and good faith of the claims or defenses made by such party litigant; but the provisions of this Section 6.14 shall not apply to any suit instituted by the
Company, to any suit instituted by the Trustee, to any suit instituted by any Holder, or group of Holders, holding in the aggregate more than 10% in principal amount of the outstanding Securities of
any Series, or to any suit instituted by any Holder for the enforcement of the payment of the principal of or interest on any Security on or after the Stated Maturity or Stated Maturities expressed in
such Security (or, in the case of redemption, on the redemption date). 

ARTICLE VII.

TRUSTEE  

        Section 7.1.    Duties of Trustee. 

         (a)  If
an Event of Default has occurred and is continuing, the Trustee shall exercise the rights and powers vested in it by this Indenture and use the same degree of care
and skill in its exercise as a prudent man would exercise or use under the circumstances in the conduct of his own affairs. 

         (b)  Except
during the continuance of an Event of Default: 

          (i)  The
Trustee need perform only those duties that are specifically set forth in this Indenture and no others. The permissive right of the Trustee to take or refrain from
taking any action hereunder shall not be construed as a duty. 

         (ii)  In
the absence of bad faith on its part, the Trustee may conclusively rely, as to the truth of the statements and the correctness of the opinions expressed therein,
upon Officers' Certificates or Opinions of Counsel furnished to the Trustee and conforming to the requirements of this Indenture; however, in the case of any such Officers' Certificates or Opinions of
Counsel which by any provisions hereof are specifically required to be furnished to the Trustee, the Trustee shall examine such Officers' Certificates and Opinions of Counsel to determine whether or
not they conform to the requirements of this Indenture. 

         (c)  The
Trustee may not be relieved from liability for its own negligent action, its own negligent failure to act or its own willful misconduct, except that: 

          (i)  This
paragraph does not limit the effect of paragraph (b) of this Section. 

         (ii)  The
Trustee shall not be liable for any error of judgment made in good faith by a Responsible Officer, unless it is proved that the Trustee was negligent in
ascertaining the pertinent facts. 

        (iii)  The
Trustee shall not be liable with respect to any action taken, suffered or omitted to be taken by it with respect to Securities of any Series in good faith in
accordance with the direction of the Holders of a majority in principal amount of the outstanding Securities of such Series relating 

21

 

to
the time, method and place of conducting any proceeding for any remedy available to the Trustee, or exercising any trust or power conferred upon the Trustee, under this Indenture with respect to
the Securities of such Series. 

         (d)  Every
provision of this Indenture that in any way relates to the Trustee is subject to paragraph (a), (b) and (c) of this Section 7.1. 

         (e)  The
Trustee may refuse to perform any duty or exercise any right or power unless it receives indemnity satisfactory to it against any loss, liability or expense. 

          (f)  The
Trustee shall not be liable for interest on any money received by it except as the Trustee may agree in writing with the Company. Money held in trust by the Trustee
need not be segregated from other funds except to the extent required by law. 

         (g)  No
provision of this Indenture shall require the Trustee to risk its own funds or otherwise incur any financial liability in the performance of any of its duties, or in
the exercise of any of its rights or powers, if it shall have reasonable grounds for believing that repayment of such funds or adequate indemnity against such risk is not reasonably assured to it. 

         (h)  The
Paying Agent, the Registrar and any authenticating agent shall be entitled to the protections, immunities and standard of care as are set forth in paragraphs (a),
(b) and (c) of this Section with respect to the Trustee. 

        Section 7.2.    Rights
of Trustee. 

         (a)  The
Trustee may rely on and shall be protected in acting or refraining from acting upon any document believed by it to be genuine and to have been signed or presented by
the proper person. The Trustee need not investigate any fact or matter stated in the document. 

         (b)  Before
the Trustee acts or refrains from acting, it may require an Officers' Certificate or an Opinion of Counsel. The Trustee shall not be liable for any action it
takes or omits to take in good faith in reliance on such Officers' Certificate or Opinion of Counsel. 

         (c)  The
Trustee may act through agents and shall not be responsible for the misconduct or negligence of any agent appointed with due care. No Depository shall be deemed an
agent of the Trustee and the Trustee shall not be responsible for any act or omission by any Depository. 

         (d)  The
Trustee shall not be liable for any action it takes or omits to take in good faith which it believes to be authorized or within its rights or powers. 

         (e)  The
Trustee may consult with counsel and the advice of such counsel or any Opinion of Counsel shall be full and complete authorization and protection in respect of any
action taken, suffered or omitted by it hereunder in good faith and in reliance thereon. 

          (f)  The
Trustee shall be under no obligation to exercise any of the rights or powers vested in it by this Indenture at the request or direction of any of the Holders of
Securities unless such Holders shall have offered to the Trustee reasonable security or indemnity against the costs, expenses and liabilities which might be incurred by it in compliance with such
request or direction. 

        Section 7.3.    Individual
Rights of Trustee. 

        The
Trustee in its individual or any other capacity may become the owner or pledgee of Securities and may otherwise deal with the Company or an Affiliate with the same rights it would
have if it were not Trustee. Any Agent may do the same with like rights. The Trustee is also subject to Sections 7.10 and 7.11. 

22

   
        Section 7.4.    Trustee's Disclaimer. 

        The
Trustee shall not be responsible for and makes no representation as to the validity or adequacy of this Indenture or the Securities, it shall not be accountable for the Company's use
of the proceeds from the Securities, and it shall not be responsible for any statement or recital herein or any statement in the Securities or any other document in connection with the sale of the
Securities or pursuant to this Indenture other than its authentication. 

        Section 7.5.    Notice
of Defaults. 

        If
a Default or Event of Default occurs and is continuing with respect to the Securities of any Series and if it is known to a Responsible Officer of the Trustee, the Trustee shall mail
to each Securityholder of the Securities of that Series and, if any Bearer Securities are outstanding, publish on one occasion in an Authorized Newspaper, notice of a Default or Event of Default
within 90 days after it occurs or, if later, after a Responsible Officer of the Trustee has knowledge of such Default or Event of Default. Except in the case of a Default or Event of Default in
payment of principal of or interest on any Security of any Series, the Trustee may withhold the notice if and so long as its corporate trust committee or a committee of its Responsible Officers in
good faith determines that withholding the notice is in the interests of Securityholders of that Series. 

        Section 7.6.    Reports
by Trustee to Holders. 

        Within
60 days after [date] in each year, the Trustee shall transmit by mail to all Securityholders, as their names and addresses appear on the register
kept by the Registrar and, if any Bearer Securities are outstanding, publish in an Authorized Newspaper, a brief report dated as of such [date], in accordance with, and to the
extent required under, TIA Section 313. 

        A
copy of each report at the time of its mailing to Securityholders of any Series shall be filed with the SEC and each stock exchange on which the Securities of that Series are listed.
The Company shall promptly notify the Trustee when Securities of any Series are listed on any stock exchange. 

        Section 7.7.    Compensation
and Indemnity. 

        The
Company shall pay to the Trustee from time to time reasonable compensation for its services. The Trustee's compensation shall not be limited by any law on compensation of a trustee
of an express trust. The Company shall reimburse the Trustee upon request for all reasonable out-of-pocket expenses incurred by it. Such expenses shall include the reasonable
compensation and expenses of the Trustee's agents and counsel. 

        The
Company shall indemnify the Trustee (including the cost of defending itself) against any loss, liability or expense incurred by it except as set forth in the next paragraph in the
performance of its duties under this Indenture as Trustee or Agent. The Trustee shall notify the Company promptly of any claim for which it may seek indemnity. The Company shall defend the claim and
the Trustee shall cooperate in the defense. The Trustee may have separate counsel and the Company shall pay the reasonable fees and expenses of such counsel. The Company need not pay for any
settlement made without its consent, which consent shall not be unreasonably withheld. This indemnification shall apply to officers, directors, employees, shareholders and agents of the Trustee. 

        The
Company need not reimburse any expense or indemnify against any loss or liability determined by a court to have been incurred by the Trustee or by any officer, director, employee,
shareholder or agent of the Trustee through negligence or bad faith. 

        To
secure the Company's payment obligations in this Section 7.7, the Trustee shall have a lien prior to the Securities of any Series on all money or property held or collected by
the Trustee, except that held in trust to pay principal and interest on particular Securities of that Series. 

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        When
the Trustee incurs expenses or renders services after an Event of Default specified in Section 6.1(e) or (f) occurs, the expenses and the compensation for the services
are intended to constitute expenses of administration under any Bankruptcy Law. 

        Section 7.8.    Replacement
of Trustee. 

        A
resignation or removal of the Trustee and appointment of a successor Trustee shall become effective only upon the successor Trustee's acceptance of appointment as provided in this
Section 7.8. 

        The
Trustee may resign with respect to the Securities of one or more Series by so notifying the Company. The Holders of a majority in principal amount of the Securities of any Series may
remove the Trustee with respect to that Series by so notifying the Trustee and the Company in writing. The Company may remove the Trustee with respect to Securities of one or more Series if: 

         (a)  the
Trustee fails to comply with Section 7.10; 

         (b)  the
Trustee is adjudged bankrupt or insolvent or an order for relief is entered with respect to the Trustee under any Bankruptcy Law; 

         (c)  a
Custodian or public officer takes charge of the Trustee or its property; or 

         (d)  the
Trustee becomes incapable of acting. 

        If
the Trustee resigns or is removed or if a vacancy exists in the office of Trustee for any reason, the Company shall promptly appoint a successor Trustee. Within one year after the
successor Trustee takes office, the Holders of a majority in principal amount of the then outstanding Securities may appoint a successor Trustee to replace the successor Trustee appointed by the
Company. 

        If
a successor Trustee with respect to the Securities of any one or more Series does not take office within 60 days after the retiring Trustee resigns or is removed, the retiring
Trustee, the Company or the Holders of at least 10% in principal amount of the Securities of the applicable Series may petition any court of competent jurisdiction for the appointment of a successor
Trustee. 

        If
the Trustee with respect to the Securities of any one or more Series fails to comply with Section 7.10, any Securityholder of the applicable Series may petition any court of
competent jurisdiction for the removal of the Trustee and the appointment of a successor Trustee. 

        A
successor Trustee shall deliver a written acceptance of its appointment to the retiring Trustee and to the Company. Immediately after that, the retiring Trustee shall transfer all
property held by it as Trustee to the successor Trustee subject to the lien provided for in Section 7.7, the resignation or removal of the retiring Trustee shall become effective, and the
successor Trustee shall have all the rights, powers and duties of the Trustee with respect to each Series of Securities for which it is acting as Trustee under this Indenture. A successor Trustee
shall mail a notice of its succession to each Securityholder of each such Series and, if any Bearer Securities are outstanding, publish such notice on one occasion in an Authorized Newspaper.
Notwithstanding replacement of the Trustee pursuant to this Section 7.8, the Company's obligations under Section 7.7 hereof shall continue for the benefit of the
retiring trustee with respect to reasonable expenses and liabilities incurred by it prior to such replacement. 

        Section 7.9.    Successor
Trustee by Merger, Etc. 

        If
the Trustee consolidates with, merges or converts into, or transfers all or substantially all of its corporate trust business to, another corporation, the successor corporation
without any further act shall be the successor Trustee. 

24

 

        Section 7.10.    Eligibility;
Disqualification. 

        This
Indenture shall always have a Trustee who satisfies the requirements of TIA Section 310(a)(1), (2) and (5). The Trustee shall always have a combined capital and
surplus of at least $25,000,000 as set forth in its most recent published annual report of condition. The Trustee shall comply with TIA Section 310(b). 

        Section 7.11.    Preferential
Collection of Claims Against Company. 

        The
Trustee is subject to TIA Section 311(a), excluding any creditor relationship listed in TIA Section 311(b). A Trustee who has resigned or been removed shall be subject
to TIA Section 311(a) to the extent indicated. 

ARTICLE VIII.

SATISFACTION AND DISCHARGE; DEFEASANCE  

        Section 8.1.    Satisfaction and Discharge of Indenture. 

        This
Indenture shall upon Company Order cease to be of further effect (except as hereinafter provided in this Section 8.1), and the Trustee, at the expense of the Company, shall
execute proper instruments acknowledging satisfaction and discharge of this Indenture, when 

         (a)  either

          (i)  all
Securities theretofore authenticated and delivered (other than Securities that have been destroyed, lost or stolen and that have been replaced or paid) have been
delivered to the Trustee for cancellation; or 

         (ii)  all
such Securities not theretofore delivered to the Trustee for cancellation pursuant to (i) above 

         (1)  have
become due and payable, or 

         (2)  will
become due and payable at their Stated Maturity within one year, or 

         (3)  are
to be called for redemption within one year under arrangements satisfactory to the Trustee for the giving of notice of redemption by the Trustee in the name, and at
the expense, of the Company, or 

         (4)  are
deemed paid and discharged pursuant to Section 8.3, as applicable; 

and
the Company, in the case of (1), (2) or (3) above, has deposited or caused to be deposited with the Trustee in trust an amount, without reinvestment, which is sufficient for the
purpose of paying and discharging the entire indebtedness on such Securities not theretofore delivered to the Trustee for cancellation, for principal and interest to the date of such deposit (in the
case of Securities which have become due and payable on or prior to the date of such deposit) or to the Stated Maturity or redemption date, as the case may be; 

         (b)  the
Company has paid or caused to be paid all other sums payable hereunder by the Company; and 

         (c)  the
Company has delivered to the Trustee an Officers' Certificate and an Opinion of Counsel, each stating that all conditions precedent herein provided for relating to
the satisfaction and discharge of this Indenture have been complied with. 

        Notwithstanding
the satisfaction and discharge of this Indenture, the obligations of the Company to the Trustee under Section 7.7, and, if money shall have been deposited with the
Trustee pursuant to clause (a) of this Section, the provisions of Sections 2.5, 2.8, 2.9, 8.1, 8.2 and 8.5 shall survive. 

25

 

        Section 8.2.    Application
of Trust Funds; Indemnification. 

         (a)  Subject
to the provisions of Section 8.5, all money deposited with the Trustee pursuant to Section 8.1, all money and Government Obligations deposited with
the Trustee pursuant to Section 8.3 or 8.4 and all money received by the Trustee in respect of Government Obligations deposited with the Trustee pursuant to Section 8.3 or 8.4, shall be
held in trust and applied by it, in accordance with the provisions of the Securities and this Indenture, to the payment, either directly or through any Paying Agent (including the Company acting as
its own Paying Agent) as the Trustee may determine, to the persons entitled thereto, of the principal and interest for whose payment such money has been deposited with or received by the Trustee or to
make mandatory sinking fund payments or analogous payments as contemplated by Sections 8.3 or 8.4. 

         (b)  The
Company shall pay and shall indemnify the Trustee against any tax, fee or other charge imposed on or assessed against Government Obligations deposited pursuant to
Sections 8.3 or 8.4 or the interest and principal received in respect of such Government Obligations other than any payable by or on behalf of Holders. 

         (c)  The
Trustee shall deliver or pay to the Company from time to time upon Company Request any Government Obligations or money held by it as provided in Sections 8.3 or 8.4
which, in the opinion of a nationally recognized firm of independent certified public accountants expressed in a written certification thereof delivered to the Trustee, are then in excess of the
amount thereof which then would have been required to be deposited for the purpose for which such Government Obligations or money were deposited or received. This provision shall not authorize the
sale by the Trustee of any Government Obligations held under this Indenture. 

        Section 8.3.    Legal
Defeasance of Securities of any Series. 

        Unless
this Section 8.3 is otherwise specified, pursuant to subparagraph 2.2.17, to be inapplicable to Securities of any Series, the Company shall be deemed to have paid and
discharged the entire indebtedness on all the outstanding Securities of such Series on the date of the deposit referred to in subparagraph (c)(1) hereof, and the provisions of this Indenture, as it
relates to such outstanding
Securities of such Series, shall no longer be in effect (and the Trustee, at the expense of the Company, shall, at Company Request, execute proper instruments acknowledging the same), except as to: 

         (a)  the
rights of Holders of Securities of such Series to receive, from the trust funds described in subparagraph (c)(1) hereof, (i) payment of the principal of and
each installment of principal of and interest on the outstanding Securities of such Series on the Stated Maturity of such principal or installment of principal or interest and (ii) the benefit
of any mandatory sinking fund payments applicable to the Securities of such Series on the day on which such payments are due and payable in accordance with the terms of this Indenture and the
Securities of such Series; 

         (b)  the
provisions of Sections 2.5, 2.8, 2.9, 8.2, 8.3 and 8.5; and 

         (c)  the
rights, powers, trust and immunities of the Trustee hereunder; 

provided
that, the following conditions shall have been satisfied: 

         (1)  The
Company shall have irrevocably deposited with the Trustee, in trust, (i) sufficient funds in the currency or currency unit in which the Securities of such
Series are denominated to pay, without reinvestment, the principal of and interest to Stated Maturity (or redemption) on, the Securities of such Series, or (ii) such amount of direct
obligations of, or obligations the principal of and interest on which are fully guaranteed by, the government which issued the currency in which the Securities of such series are denominated
("Government Obligations"), and which are not subject to prepayment, redemption or call, as will, together with the predetermined and certain income to accrue thereon without consideration of any
reinvestment thereof, be sufficient to pay when due the principal of, and interest to Stated Maturity (or redemption) on, the Securities of such Series. 

26

 

         (2)  The
Company shall (i) have delivered an Opinion of Counsel that the Company has met all of the conditions precedent to such defeasance and that the Holders of the
Securities of such Series will not recognize income, gain or loss for United States Federal income tax purposes as a result of such defeasance, and will be subject to tax in the same manner as if no
defeasance and discharge or covenant defeasance, as the case may be, had occurred or (ii) the Company shall have delivered to the Trustee an Opinion of Counsel to the effect that (A) the
Company has received from, or there has been published by, the Internal Revenue Service a ruling or (B) since the date this Indenture was first executed, there has been a change in the
applicable federal income tax law, in either case to the effect that, and based thereon such Opinion of Counsel in the United States shall confirm that, the holders of outstanding Securities of that
particular Series will not recognize income, gain or loss for federal income tax purposes as a result of such defeasance. 

        Section 8.4.    Covenant
Defeasance. 

        Unless
this Section 8.4 is otherwise specified pursuant to subparagraph 2.2.17 to be inapplicable to Securities of any Series, on the date of the deposit referred to in
subparagraph (a) hereof, the Company may omit to comply with any term, provision or condition set forth under Sections 4.2, 4.3, 4.4, 4.5 and 5.1 as well as any additional covenants contained
in a supplemental indenture hereto for a particular Series of Securities or a Board Resolution or an Officers' Certificate delivered pursuant to Section 2.2.21 (and the failure to comply with
any such covenants shall not constitute a Default or Event of Default under Section 6.1) and the occurrence of any event described in clause (e) of Section 6.1 shall not
constitute a Default or Event of Default hereunder, with respect to the Securities of such Series, provided that the following conditions shall have been satisfied: 

         (a)  The
Company shall have irrevocably deposited with the Trustee, in trust, (i) sufficient funds in the currency or currency unit in which the Securities of such
Series are denominated to pay the principal of and interest to Stated Maturity (or redemption) on, the Securities of such Series, or (ii) such amount of Government Obligations, which are not
subject to prepayment, redemption or call, as will, together with the predetermined and certain income to accrue thereon without consideration of any reinvestment thereof, be sufficient to pay when
due the principal of, and interest to Stated Maturity (or redemption) on, the Securities of such Series. 

         (b)  The
Company shall have delivered an Opinion of Counsel that the Company has met all of the conditions precedent to such defeasance and that the Holders of the Securities
of such series will not recognize income, gain or loss for United States Federal income tax purposes as a result of such defeasance, and will be subject to tax in the same manner as if no defeasance
and discharge or covenant defeasance, as the case may be, had occurred. 

        Section 8.5.    Repayment
to Company. 

        The
Trustee and the Paying Agent shall pay to the Company upon request any money held by them for the payment of principal and interest that remains unclaimed for two years. After that,
Securityholders entitled to the money must look to the Company for payment as general creditors unless an applicable abandoned property law designates another person. 

ARTICLE IX.

AMENDMENTS AND WAIVERS  

        Section 9.1.    Without Consent of Holders. 

        The
Company and the Trustee may amend or supplement this Indenture or the Securities of one or more Series without the consent of any Securityholder: 

         (a)  to
evidence the succession of another corporation to the Company and the assumption by any such successor of the covenants of the Company herein and in the Securities; 

27

 

         (b)  to
add to the covenants, agreements and obligations of the Company for the benefit of the Holders of all of the Securities or any Series thereof, or to surrender any
right or power herein conferred upon the Company; 

         (c)  to
establish the forms or terms of Securities of any Series; 

         (d)  to
evidence and provide for the acceptance of appointment hereunder by a successor Trustee with respect to the Securities of one or more series and to add to or change
any of the provisions of this Indenture as shall be necessary to provide for or facilitate the administration of the trusts hereunder by more than one Trustee, pursuant to the requirements of
Section 7.8; 

         (e)  to
cure any ambiguity, defect or inconsistency; 

          (f)  to
add to, change or eliminate any of the provisions of this Indenture (which addition, change or elimination may apply to one or more Series of Securities), provided
that any such addition, change or elimination shall neither (i) apply to any Security of any Series created prior to the execution of such supplemental indenture and entitled to the benefit of
such provision nor (ii) modify the rights of the Holder of any such Security with respect to such provision; 

         (g)  to
secure the Securities; or 

         (h)  to
make any other change that does not adversely affect the rights of any Securityholder in any material respect. 

        Section 9.2.    With
Consent of Holders. 

        With
the written consent of the Holders of at least a majority in aggregate principal amount of the outstanding Securities of each Series affected by such supplemental indenture, the
Company and the Trustee may amend this Indenture or the Securities of any Series or may enter into an indenture or indentures supplemental hereto for the purpose of adding any provisions to or
changing in any manner or eliminating any of the provisions of this Indenture or of modifying in any manner the rights of the Holders of the Securities of such series and any related coupons under
this Indenture; provided, however, that no such amendment or supplemental indenture shall, without the consent of the Holder of each outstanding Security affected thereby: 

         (a)  change
the Stated Maturity of the principal of, or any installment of principal or interest on, any such Security or reduce the principal amount thereof or the rate of
interest thereon or any premium payable upon redemption thereof or reduce the amount of principal of any such Discount Security that would be due and payable upon a declaration of acceleration of
maturity thereof pursuant to Section 6.2, or change the coin or currency in which, any principal of, or any installment of interest on, any such Security is payable, or impair the right to
institute suit for the enforcement of any such payment on or after the Stated Maturity thereof (or, in the case of redemption, on or after the redemption date); 

         (b)  reduce
the percentage in principal amount of the outstanding Securities of any series, the consent of whose Holders is required for any such amendment or supplemental
indenture, or the consent of whose Holders is required for any waiver (of compliance with certain provisions of this Indenture or certain defaults hereunder and their consequences) with respect to the
Securities of such Series provided for in this Indenture; or 

         (c)  modify
any of the provisions of this Section, Section 6.4 or 6.7, except to increase the percentage of outstanding Securities of such Series required for such
actions to provide that certain other provisions of this Indenture cannot be modified or waived without the consent of the Holder of each outstanding Security affected thereby. 

        A
supplemental indenture which changes or eliminates any covenant or other provision of this Indenture which has expressly been included solely for the benefit of one or more particular
Series of 

28

 

Securities,
or which modifies the rights of the Holders of Securities of such Series with respect to such covenant or other provision, shall be deemed not to affect the rights under this Indenture of
the Holders of Securities of any other Series. 

        An
amendment may not make any change that adversely affects the rights under Article XII of any Holder of Senior Indebtedness then outstanding unless the requisite holders of such
Senior Indebtedness consent to such change pursuant to the terms of such Senior Indebtedness. 

        It
shall not be necessary for the consent of the Holders under this Section 9.2 to approve the particular form of any proposed amendment or supplemental indenture, but it shall be
sufficient if such consent approves the substance thereof. 

        After
an amendment or supplemental indenture under this Section 9.2 becomes effective, the Company shall mail to each Holder of the particular Securities affected thereby and, if
any Bearer Securities affected thereby are outstanding, publish on one occasion in an Authorized Newspaper, a notice briefly describing the amendment. Any failure by the Company to mail or publish
such notice, or any defect therein, shall not, however, in any way impair or affect the validity of any such amendment or supplemental indenture. 

        Section 9.3.    Compliance
with Trust Indenture Act. 

        Every
amendment to this Indenture or the Securities of one or more Series shall be set forth in a supplemental indenture hereto that complies with the TIA as then in effect. 

        Section 9.4.    Revocation
and Effect of Consents. 

        Until
an amendment or waiver becomes effective, a consent to it by a Holder of a Security is a continuing consent by the Holder and every subsequent Holder of a Security or portion of a
Security that evidences the same debt as the consenting Holder's Security, even if notation of the consent is not made on any Security. However, any such Holder or subsequent Holder may revoke the
consent as to his Security or portion of a Security if the Trustee receives the notice of revocation before the date the amendment or waiver becomes effective. 

        Any
amendment or waiver once effective shall bind every Securityholder of each Series affected by such amendment or waiver unless it is of the type described in any of clauses
(a) through (c) of Section 9.2. In that case, the amendment or waiver shall bind each Holder of a Security who has consented to it and every subsequent Holder of a Security or
portion of a Security that evidences the same debt as the consenting Holder's Security. 

        Section 9.5.    Notation
on or Exchange of Securities. 

        The
Trustee may place an appropriate notation about an amendment or waiver on any Security of any Series thereafter authenticated. The Company in exchange for Securities of that Series
may issue and the Trustee shall authenticate upon request new Securities of that Series that reflect the amendment or waiver. 

        Section 9.6.    Trustee
Protected. 

        In
executing, or accepting the additional trusts created by, any supplemental indenture permitted by this Article IX or the modifications thereby of the trusts created by this
Indenture, the Trustee shall be entitled to receive, and (subject to Section 7.1) shall be fully protected in relying upon, an Opinion of Counsel stating that the execution of such supplemental
indenture is authorized or permitted by this Indenture. The Trustee shall sign all supplemental indentures, except that the Trustee need not sign any supplemental indenture that adversely affects its
rights. 

29

 

ARTICLE X.

MISCELLANEOUS  

        Section 10.1.    Trust Indenture Act Controls. 

        If
any provision of this Indenture limits, qualifies, or conflicts with another provision which is required or deemed to be included in this Indenture by the TIA, such required or deemed
provision shall control. 

        Section 10.2.    Notices.

        Any
notice or communication by the Company or the Trustee to the other is duly given if in writing and delivered in person or mailed by first-class mail (registered or certified, return
receipt requested), telecopier or overnight air courier guaranteeing next day delivery, to the other's address: 

if
to the Company: 

Superior
Essex Inc.

150 Interstate North Parkway

Atlanta, Georgia 30339

Attention: Chief Financial Officer

Fax:            

if
to the Trustee: 

The
Bank of New York Trust Company, N.A.

100 Ashford Center North, Suite 520

Atlanta, Georgia 30338

Attention: Corporate Trust Department

Fax:            

        The
Company or the Trustee by notice to the other may designate additional or different addresses for subsequent notices or communications. 

        Any
notice or communication to a Securityholder shall be mailed by first-class mail, certified or registered, return receipt requested, or by overnight courier guaranteeing next day
delivery to his or her address shown on the register kept by the Registrar and, if any Bearer Securities are outstanding, published in an Authorized Newspaper. Failure to mail a notice or
communication to a Securityholder of any Series or any defect in it shall not affect its sufficiency with respect to other Securityholders of that or any other Series. 

        If
a notice or communication is mailed, personally delivered or published in the manner provided above, within the time prescribed, it is duly given, whether or not the Securityholder
receives it. 

        If
the Company mails a notice or communication to Securityholders, it shall mail a copy to the Trustee and each Agent at the same time. 

30

   
        Section 10.3.    Communication by Holders with Other Holders. 

        Securityholders
of any Series may communicate pursuant to TIA Section 312(b) with other Securityholders of that Series or any other Series with respect to their rights under this
Indenture or the Securities of that Series or all Series. The Company, the Trustee, the Registrar and anyone else shall have the protection of TIA Section 312(c). 

        Section 10.4.    Certificate
and Opinion as to Conditions Precedent. 

        Upon
any request or application by the Company to the Trustee to take any action under this Indenture, the Company shall furnish to the Trustee: 

         (a)  an
Officers' Certificate stating that, in the opinion of the signers, all conditions precedent, if any, provided for in this Indenture relating to the proposed action
have been complied with; and 

         (b)  an
Opinion of Counsel stating that, in the opinion of such counsel, all such conditions precedent have been complied with. 

        Section 10.5.    Statements
Required in Certificate or Opinion. 

        Each
certificate or opinion with respect to compliance with a condition or covenant provided for in this Indenture (other than a certificate provided pursuant to TIA
Section 314(a)(4)) shall comply with the provisions of TIA Section 314(e) and shall include: 

         (a)  a
statement that the person making such certificate or opinion has read such covenant or condition; 

         (b)  a
brief statement as to the nature and scope of the examination or investigation upon which the statements or opinions contained in such certificate or opinion are
based; 

         (c)  a
statement that, in the opinion of such person, he has made such examination or investigation as is necessary to enable him to express an informed opinion as to whether
or not such covenant or condition has been complied with; and 

         (d)  a
statement as to whether or not, in the opinion of such person, such condition or covenant has been complied with. 

        Section 10.6.    Rules
by Trustee and Agents. 

        The
Trustee may make reasonable rules for action by or a meeting of Securityholders of one or more Series. Any Agent may make reasonable rules and set reasonable requirements for its
functions. 

        Section 10.7.    Legal
Holidays. 

        Unless
otherwise provided by Board Resolution, Officers' Certificate or supplemental indenture for a particular Series, a "Legal Holiday" is any day that is not a Business Day. If a
payment date is a Legal Holiday at a place of payment, payment may be made at that place on the next succeeding day that is not a Legal Holiday, and no interest shall accrue for the intervening
period. 

        Section 10.8.    No
Recourse Against Others. 

        A
director, officer, employee or stockholder, as such, of the Company shall not have any liability for any obligations of the Company under the Securities or the Indenture or for any
claim based on, in respect of or by reason of such obligations or their creation. Each Securityholder by accepting a Security waives and releases all such liability. The waiver and release are part of
the consideration for the issue of the Securities. All Securities, including Global Securities, shall bear a legend in a form substantially setting forth the foregoing statements in this
Section 10.8. 

31

 

        Section 10.9.    Counterparts.

        This
Indenture may be executed in any number of counterparts and by the parties hereto in separate counterparts, each of which when so executed shall be deemed to be an original and all
of which taken together shall constitute one and the same agreement. 

        Section 10.10.    Governing
Laws. 

        THIS
INDENTURE AND THE SECURITIES SHALL BE GOVERNED BY THE LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED IN SUCH STATE, WITHOUT REGARD TO THE CONFLICT
OF LAWS PROVISIONS THEREOF. 

        Section 10.11.    No
Adverse Interpretation of Other Agreements. 

        This
Indenture may not be used to interpret another indenture, loan or debt agreement of the Company or a Subsidiary. Any such indenture, loan or debt agreement may not be used to
interpret this Indenture. 

        Section 10.12.    Successors.

        All
agreements of the Company in this Indenture and the Securities shall bind its successor. All agreements of the Trustee in this Indenture shall bind its successor. 

        Section 10.13.    Severability.

        In
case any provision in this Indenture or in the Securities shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not
in any way be affected or impaired thereby. 

        Section 10.14.    Table
of Contents, Headings, Etc. 

        The
Table of Contents, Cross Reference Table, and headings of the Articles and Sections of this Indenture have been inserted for convenience of reference only, are not to be considered a
part hereof, and shall in no way modify or restrict any of the terms or provisions hereof. 

ARTICLE XI.

SINKING FUNDS  

        Section 11.1.    Applicability of Article. 

        The
provisions of this Article XI shall be applicable to any sinking fund for the retirement of the Securities of a Series, except as otherwise permitted or required by any form
of Security of such Series issued pursuant to this Indenture. 

        The
minimum amount of any sinking fund payment provided for by the terms of the Securities of any Series is herein referred to as a "mandatory sinking fund payment" and any other amount
provided for by the terms of Securities of such Series is herein referred to as an "optional sinking fund payment." If provided for by the terms of Securities of any Series, the cash amount of any
sinking fund payment may be subject to reduction as provided in Section 11.2. Each sinking fund payment shall be applied to the redemption of Securities of any Series as provided for by the
terms of the Securities of such Series. 

        Section 11.2.    Satisfaction
of Sinking Fund Payments with Securities. 

        The
Company may, in satisfaction of all or any part of any sinking fund payment with respect to the Securities of any Series to be made pursuant to the terms of such Securities
(1) deliver outstanding Securities of such Series to which such sinking fund payment is applicable (other than any of such Securities previously called for mandatory sinking fund redemption)
and (2) apply as a credit Securities 

32

 

of
such Series to which such sinking fund payment is applicable and which have been redeemed either at the election of the Company pursuant to the terms of such Series of Securities (except pursuant
to any mandatory sinking fund) or through the application of permitted optional sinking fund payments or other optional redemptions pursuant to the terms of such Securities, provided that such
Securities have not been previously so credited. Such Securities shall be received by the Trustee, together with an Officers' Certificate with respect thereto, not later than 15 days prior to
the date on which the Trustee begins the process of selecting Securities for redemption, and shall be credited for such purpose by the Trustee at the price specified in such Securities for redemption
through operation of the sinking fund and the amount of such sinking fund payment shall be reduced accordingly. If as a result of the delivery or credit of Securities in lieu of cash payments pursuant
to this Section 11.2. The principal amount of Securities of such Series to be redeemed in order to exhaust the aforesaid cash payment shall be less than $100,000, the Trustee need not call
Securities of such Series for redemption, except upon receipt of a Company Order that such action be taken, and such cash payment shall be held by the Trustee or a Paying Agent and applied to the next
succeeding sinking fund payment, provided, however, that the Trustee or such Paying Agent shall from time to time upon receipt of a Company Order pay over and deliver to the Company any cash payment
so being held by the Trustee or such Paying Agent upon delivery by the Company to the Trustee of Securities of that Series purchased by the Company having an unpaid principal amount equal to the cash
payment required to be released to the Company. 

        Section 11.3.    Redemption
of Securities for Sinking Fund. 

        Not
less than 45 days (unless otherwise indicated in the Board Resolution, supplemental indenture hereto or Officers' Certificate in respect of a particular Series of Securities)
prior to each sinking fund payment date for any Series of Securities, the Company will deliver to the Trustee an Officers' Certificate specifying the amount of the next ensuing mandatory sinking fund
payment for that Series pursuant to the terms of that Series, the portion thereof, if any, which is to be satisfied by payment of cash and the portion thereof, if any, which is to be satisfied by
delivering and crediting of Securities of that Series pursuant to Section 11.2. and the optional amount, if any, to be added in cash to the next ensuing mandatory sinking fund payment, and the
Company shall thereupon be obligated to pay the amount therein specified. Not less than 30 days (unless otherwise indicated in the Board Resolution, Officers' Certificate or supplemental
indenture in respect of a particular Series of Securities) before each such sinking fund payment date the Trustee shall select the Securities to be redeemed upon such sinking fund payment date in the
manner specified in Section 3.2 and cause notice of the redemption thereof to be given in the name of and at the expense of the Company in the manner provided in Section 3.3. Such notice
having been duly given, the redemption of such Securities shall be made upon the terms and in the manner stated in Sections 3.4, 3.5 and 3.6. 

ARTICLE XII.

SUBORDINATION OF SECURITIES  

        Section 12.1.    Agreement of Subordination. 

        The
Company covenants and agrees, and each Holder of Securities issued hereunder by his or her acceptance thereof likewise covenants and agrees, that all Securities shall be issued
subject to the provisions of this Article XII; and each Person holding any Security, whether upon original issue or upon transfer, assignment or exchange thereof, accepts and agrees to be bound
by such provisions. 

        The
payment of the principal of, premium, if any, and interest on all Securities (including, but not limited to, the redemption price with respect to the Securities called for redemption
in accordance with Article 3 as provided in the Indenture) issued hereunder shall, to the extent and in the manner hereinafter set forth, be subordinated and subject in right of payment to the
prior payment in full of all Senior Indebtedness, whether outstanding at the date of this Indenture or thereafter incurred. 

33

 

        No
provision of this Article XII shall prevent the occurrence of any Default or Event of Default hereunder. 

        Section 12.2.    Payments
to Holders. 

        No
payment shall be made with respect to the principal of, or premium, if any, or interest on the Securities (including, but not limited to, the redemption price with respect to the
Securities to be called for redemption in accordance with Article III as provided in the Indenture), except payments and distributions made by the Trustee as permitted by the first or second
paragraph of Section 12.5, if: 

          (i)  a
default in the payment of principal, premium, interest or other obligations due on any Senior Indebtedness occurs and is continuing (or, in the case of Senior
Indebtedness for which there is a period of grace, in the event of such a default that continues beyond the period of grace, if any, specified in the instrument or lease evidencing such Senior
Indebtedness), unless and until such default shall have been cured or waived or shall have ceased to exist; or 

         (ii)  a
default, other than a payment default, on a Designated Senior Indebtedness occurs and is continuing that then permits holders of such Designated Senior Indebtedness
to accelerate its maturity and the Trustee receives a notice of the default (a "Payment Blockage Notice") from a Representative or the Company. 

        If
the Trustee receives any Payment Blockage Notice pursuant to clause (ii) above, no subsequent Payment Blockage Notice shall be effective for purposes of this
Section 12.1 unless and until (A) at least 365 days shall have elapsed since the initial effectiveness of the immediately prior Payment Blockage Notice, and (B) all
scheduled payments of principal, premium, if any, and interest on the Securities that have come due have been paid in full in cash. No nonpayment default that existed or was continuing on the date of
delivery of any Payment Blockage Notice to the Trustee shall be, or be made, the basis for a subsequent Payment Blockage Notice. 

        The
Company may and shall resume payments on and distributions in respect of the Securities upon the earlier of: 

         (1)  the
date upon which the default is cured or waived or ceases to exist, or 

         (2)  in
the case of a default referred to in clause (ii) above, 179 days after notice is received if the maturity of such Designated Senior Indebtedness has not
been accelerated, 

unless
this Article XII otherwise prohibits the payment or distribution at the time of such payment or distribution. 

        Upon
any payment by the Company, or distribution of assets of the Company of any kind or character, whether in cash, property or securities, to creditors upon any dissolution or
winding-up or liquidation or reorganization of the Company, whether voluntary or involuntary or in bankruptcy, insolvency, receivership or other proceedings, all amounts due or to become
due upon all Senior Indebtedness shall first be paid in full in cash or other payment satisfactory to the holders of such Senior Indebtedness, or payment thereof in accordance with its terms provided
for in cash or other payment satisfactory to the holders of such Senior Indebtedness, before any payment is made on account of the principal of, premium, if any, or interest on the Securities (except
payments made pursuant to Article VI from monies deposited with the Trustee pursuant thereto prior to commencement of proceedings for such dissolution, winding-up, liquidation or
reorganization); and upon any such dissolution or winding-up or liquidation or reorganization of the Company or bankruptcy, insolvency, receivership or other proceeding, any payment by the
Company, or distribution of assets of the Company of any kind or character, whether in cash, property or securities, to which the Holders of the Securities or the Trustee would be entitled, except for
the provision of this Article XII, shall (except as aforesaid) be paid by the Company or by any receiver, trustee in bankruptcy, liquidating trustee, agent or other Person making such payment
or distribution, or by the Holders of 

34

 

the
Securities or by the Trustee under this Indenture if received by them or it, directly to the holders of Senior Indebtedness (pro rata to such holders on the basis of the respective amounts of
Senior Indebtedness held by such holders, or as otherwise required by law or a court order) or their representative or representatives, or to the trustee or trustees under any indenture pursuant to
which any instruments evidencing any Senior Indebtedness may have been issued, as their respective interests may appear, to the extent necessary to pay all Senior Indebtedness in full, in cash or
other payment satisfactory to the holders of such Senior Indebtedness, after giving effect to any concurrent payment or distribution to or for the holders of Senior Indebtedness, before any payment or
distribution or provision therefor is made to the Holders of the Securities or to the Trustee. 

        For
purposes of this Article XII, the words, "cash, property or securities" shall not be deemed to include shares of stock of the Company as reorganized or readjusted, or
securities of the Company or any other corporation provided for by a plan of reorganization or readjustment, the payment of which is subordinated at least to the extent provided in this
Article XII with respect to the Securities to the payment of all Senior Indebtedness which may at the time be outstanding; provided that (i) the Senior Indebtedness is assumed by the new
corporation, if any, resulting from any reorganization or readjustment, and (ii) the rights of the holders of Senior Indebtedness (other than leases which are not assumed by the Company or the
new corporation, as the case may be) are not, without the consent of such holders, altered by such reorganization or readjustment. The consolidation of the Company with, or the merger of the Company
into, another corporation or the liquidation or dissolution of the Company following the conveyance or transfer of its property as an entirety, or substantially as an entirety, to another corporation
upon the terms and conditions provided for in Article V shall not be deemed a dissolution, winding-up, liquidation or reorganization for the purposes of this Section 12.2 if
such other corporation shall, as a part of such consolidation, merger, conveyance or transfer, comply with the conditions stated in Article V. 

        In
the event of the acceleration of the Securities because of an Event of Default, no payment or distribution shall be made to the Trustee or any Holder of Securities in respect of the
principal of,
premium, if any, or interest on the Securities (including, but not limited to, the redemption price with respect to the Securities called for redemption in accordance with Article III as
provided in the Indenture), except payments and distributions made by the Trustee as permitted by the first or second paragraph of Section 12.5, until all Senior Indebtedness has been paid in
full in cash or other payment satisfactory to the holders of Senior Indebtedness or such acceleration is rescinded in accordance with the terms of this Indenture. If payment of the Securities is
accelerated because of an Event of Default, the Company shall promptly notify holders of Senior Indebtedness of the acceleration. 

        In
the event that, notwithstanding the foregoing provisions, any payment or distribution of assets of the Company of any kind or character, whether in cash, property or securities
(including, without limitation, by way of setoff or otherwise), prohibited by the foregoing, shall be received by the Trustee or the Holders of the Securities before all Senior Indebtedness is paid in
full in cash or other payment satisfactory to the holders of such Senior Indebtedness, or provision is made for such payment thereof in accordance with its terms in cash or other payment satisfactory
to the holders of such Senior Indebtedness, such payment or distribution shall be held in trust for the benefit of and shall be paid over or delivered to the holders of Senior Indebtedness or their
representative or representatives, or to the trustee or trustees under any indenture pursuant to which any instruments evidencing any Senior Indebtedness may have been issued, as their respective
interests may appear, as calculated by the Company, for application to the payment of all Senior Indebtedness remaining unpaid to the extent necessary to pay all Senior Indebtedness in full in cash or
other payment satisfactory to the holders of such Senior Indebtedness, after giving effect to any concurrent payment or distribution to or for the holders of such Senior Indebtedness. 

35

   
        Nothing in this Section 12.2 shall apply to claims of, or payments to, the Trustee under or pursuant to Section 7.7. This Section 12.2 shall be subject to the
further provisions of Section 12.5. 

        Section 12.3.    Subrogation
of Securities. 

        Subject
to the payment in full of all Senior Indebtedness, the rights of the Holders of the Securities shall be subrogated to the extent of the payments or distributions made to the
holders of such Senior Indebtedness pursuant to the provisions of this Article XII (equally and ratably with the holders of all indebtedness of the Company which by its express terms is
subordinated to other indebtedness of the Company to substantially the same extent as the Securities are subordinated and is entitled to like rights of subrogation) to the rights of the holders of
Senior Indebtedness to receive payments or distributions of cash, property or securities of the Company applicable to the Senior Indebtedness until the principal, premium, if any, and interest on the
Securities shall be paid in full; and, for the purposes of such subrogation, no payments or distributions to the holders of the Senior Indebtedness of any cash, property or securities to which the
Holders of the Securities or the Trustee would be entitled except for the provisions of this Article XII, and no payment over pursuant to the provisions of this Article XII, to or for
the benefit of the holders of Senior Indebtedness by Holders of the Securities or the Trustee, shall, as between the Company, its creditors other than holders of Senior Indebtedness, and the Holders
of the Securities, be deemed to be a payment by the Company to or on account of the Senior Indebtedness; and no payments or distributions of cash, property or securities to or for the benefit of the
Holders of the Securities pursuant to the subrogation provisions of this Article XII, which would otherwise have been paid to the holders of Senior Indebtedness shall be deemed to be a payment
by the Company to or for the account of the Securities. It is understood that the provisions of this Article XII are and are intended solely for the purposes of defining the relative rights of
the Holders of the Securities, on the one hand, and the holders of the Senior Indebtedness, on the other hand. 

        Nothing
contained in this Article XII or elsewhere in this Indenture or in the Securities is intended to or shall impair, as among the Company, its creditors other than the
holders of Senior Indebtedness, and the Holders of the Securities, the obligation of the Company, which is absolute and unconditional, to pay to the Holders of the Securities the principal of (and
premium, if any) and interest on the Securities as and when the same shall become due and payable in accordance with their terms, or is intended to or shall affect the relative rights of the Holders
of the Securities and creditors of the Company other than the holders of the Senior Indebtedness, nor shall anything herein or therein prevent the Trustee or the Holder of any Security from exercising
all remedies otherwise permitted by applicable law upon default under this Indenture, subject to the rights, if any, under this Article XII of the holders of Senior Indebtedness in respect of
cash, property or securities of the Company received upon the exercise of any such remedy. 

        Upon
any payment or distribution of assets of the Company referred to in this Article XII, the Trustee, subject to the provisions of Section 7.1, and the Holders of the
Securities shall be entitled to rely upon any order or decree made by any court of competent jurisdiction in which such bankruptcy, dissolution, winding-up, liquidation or reorganization
proceedings are pending, or a certificate of the receiver, trustee in bankruptcy, liquidating trustee, agent or other person making such payment or distribution, delivered to the Trustee or to the
Holders of the Securities, for the purpose of ascertaining the persons entitled to participate in such distribution, the holders of the Senior Indebtedness and other indebtedness of the Company, the
amount thereof or payable thereon and all other facts pertinent thereto or to this Article XII. 

        Section 12.4.    Authorization
to Effect Subordination. 

        Each
Holder of a Security by the Holder's acceptance thereof authorizes and directs the Trustee on the Holder's behalf to take such action as may be necessary or appropriate to
effectuate the subordination as provided in this Article XII and appoints the Trustee to act as the Holder's 

36

 

attorney-in-fact
for any and all such purposes. If the Trustee does not file a proper proof of claim or proof of debt in the form required in any proceeding referred to
in Section 6.3 hereof at least 30 days before the expiration of the time to file such claim, the holders of any Senior Indebtedness or their representatives are hereby authorized to file
an appropriate claim for and on behalf of the Holders of the Securities. 

        Section 12.5.    Notice
to Trustee. 

        The
Company shall give prompt written notice in the form of an Officers' Certificate to a Responsible Officer of the Trustee and to any Paying Agent of any fact known to the Company
which would prohibit the making of any payment of monies to or by the Trustee or any Paying Agent in respect of the Securities pursuant to the provisions of this Article XII. Notwithstanding
the provisions of this Article XII or any other provision of this Indenture, the Trustee shall not be charged with knowledge of the existence of any facts which would prohibit the making of any
payment of monies to or by the Trustee in respect of the Securities pursuant to the provisions of this Article XII, unless and until a Responsible Officer of the Trustee shall have received
written notice thereof at the Corporate Trust Office from the Company (in the form of an Officers' Certificate) or a Representative or a holder or holders of Senior Indebtedness or from any trustee
thereof; and before the receipt of any such written notice, the Trustee, subject to the provisions of Section 7.1, shall be entitled in all respects to assume that no such facts exist; provided
that if on a date not fewer than two Business Days prior to the date upon which by the terms hereof any such monies may become payable for any purpose (including, without limitation, the payment of
the principal of, or premium, if any, or interest on any Security) the Trustee shall not have received, with respect to such monies, the notice provided for in this Section 12.5, then, anything
herein contained to the contrary notwithstanding, the Trustee shall have full power and authority to receive such monies and to apply the same to the purpose for which they were received,
and shall not be affected by any notice to the contrary which may be received by it on or after such prior date. 

        Notwithstanding
anything in this Article XII to the contrary, nothing shall prevent any payment by the Trustee to the Holders of monies deposited with it pursuant to
Section 8.1, and any such payment shall not be subject to the provisions of Section 12.1 or 12.2. 

        The
Trustee, subject to the provisions of Section 7.1, shall be entitled to rely on the delivery to it of a written notice by a Representative or a person representing himself to
be a holder of Senior Indebtedness (or a trustee on behalf of such holder) to establish that such notice has been given by a Representative or a holder of Senior Indebtedness or a trustee on behalf of
any such holder or holders. In the event that the Trustee determines in good faith that further evidence is required with respect to the right of any person as a holder of Senior Indebtedness to
participate in any payment or distribution pursuant to this Article XII, the Trustee may request such person to furnish evidence to the reasonable satisfaction of the Trustee as to the amount
of Senior Indebtedness held by such person, the extent to which such person is entitled to participate in such payment or distribution and any other facts pertinent to the rights of such person under
this Article XII, and if such evidence is not furnished the Trustee may defer any payment to such person pending judicial determination as to the right of such person to receive such payment. 

        Section 12.6.    Trustee's
Relation to Senior Indebtedness. 

        The
Trustee in its individual capacity shall be entitled to all the rights set forth in this Article XII in respect of any Senior Indebtedness at any time held by it, to the same
extent as any other holder of Senior Indebtedness, and nothing in Section 7.11 or elsewhere in this Indenture shall deprive the Trustee of any of its rights as such holder. 

        With
respect to the holders of Senior Indebtedness, the Trustee undertakes to perform or to observe only such of its covenants and obligations as are specifically set forth in this
Article XII, and 

37

 

no
implied covenants or obligations with respect to the holders of Senior Indebtedness shall be read into this Indenture against the Trustee. The Trustee shall not be deemed to owe any fiduciary duty
to the holders of Senior Indebtedness and, subject to the provisions of Section 7.1, the Trustee shall not be liable to any holder of Senior Indebtedness if it shall pay over or deliver to
Holders of Securities, the Company or any other person money or assets to which any holder of Senior Indebtedness shall be entitled by virtue of this Article XII or otherwise. 

        Section 12.7.    No
Impairment of Subordination. 

        No
right of any present or future holder of any Senior Indebtedness to enforce subordination as herein provided shall at any time in any way be prejudiced or impaired by any act or
failure to act on the part of the Company or by any act or failure to act, in good faith, by any such holder, or by any noncompliance by the Company with the terms, provisions and covenants of this
Indenture, regardless of any knowledge thereof which any such holder may have or otherwise be charged with. 

        Section 12.8.    Article
Applicable to Paying Agents. 

        If
at any time any Paying Agent other than the Trustee shall have been appointed by the Company and be then acting hereunder, the term "Trustee" as used in this Article XII shall
(unless the context otherwise requires) be construed as extending to and including such Paying Agent within its meaning as fully for all intents and purposes as if such Paying Agent were named in this
Article XII in addition to or in place of the Trustee; provided, however, that the first paragraph of Section 12.5 shall not apply to the Company or any Affiliate of the Company if it or
such Affiliate acts as Paying Agent. 

        Section 12.9.    Senior
Indebtedness Entitled to Rely. 

        The
holders of Senior Indebtedness (including, without limitation, Designated Senior Indebtedness) shall have the right to rely upon this Article XII, and no amendment or
modification of the provisions contained herein shall diminish the rights of such holders unless such holders shall have agreed in writing thereto. 

ARTICLE XIII.

GUARANTEES  

        Section 13.1.    Unconditional Guarantee. 

         (a)  Each
Subsidiary Guarantor hereby, jointly and severally, unconditionally guarantees to each Holder and to the Trustee the due and punctual payment of the principal of,
and interest on the Securities and all other amounts due and payable under this Indenture and the Securities by the Company whether at maturity, by acceleration, redemption, repurchase or otherwise,
including, without limitation, interest on the overdue principal of and interest on the Securities, to the extent lawful, all in accordance with the terms hereof and thereof; subject, however, to the
limitations set forth in this Article XIII. 

         (b)  Failing
payment when due of any amount so guaranteed for whatever reason, the Subsidiary Guarantors will be jointly and severally obligated to pay the same immediately.
Each Subsidiary Guarantor hereby agrees that its obligations hereunder shall be unconditional, irrespective of the validity, regularity or enforceability of the Securities or this Indenture, the
absence of any action to enforce the same, any waiver or consent by any Holder of the Securities with respect to any provisions hereof or thereof, the recovery of any judgment against the Company, any
action to enforce the same or any other circumstance which might otherwise constitute a legal or equitable discharge or defense of a guarantor. Each Subsidiary Guarantor hereby waives diligence,
presentment, demand of payments, filing of claims with a court in the event of insolvency or bankruptcy of the Company, any right to require a proceeding first against the Company, protest, notice and
all demands whatsoever and covenants that this Subsidiary Guarantee will not be discharged except by complete performance of the 

38

 

obligations
contained in the Securities, this Indenture and in the Subsidiary Guarantee. If any Holder or the Trustee is required by any court or otherwise to return to the Company, any Subsidiary
Guarantor, or any custodian, trustee, liquidator or other similar official acting in relation to the Company or any Subsidiary Guarantor, any amount paid by the Company or any Subsidiary Guarantor to
the Trustee or such Holder, the Subsidiary Guarantee, to the extent theretofore discharged, shall be reinstated in full force and effect. Each Subsidiary Guarantor agrees it shall not be entitled to
any right of subrogation in relation to the Holders in respect of any obligations guaranteed hereby until payment in full of all obligations guaranteed hereby. Each Subsidiary Guarantor further agrees
that, as between each Subsidiary Guarantor, on the one hand, and the Holders and the Trustee, on the other hand, (1) the maturity of the payment of principal of, interest, if any, and
additional interest, if any, with respect to the Securities guaranteed hereby may be accelerated as provided in Article VI for the purposes of the applicable Subsidiary Guarantee,
notwithstanding any stay, injunction or other prohibition preventing such acceleration in respect of the obligations guaranteed in this Indenture, and (2) in the event of any acceleration of
such obligations as provided in Article VI, such obligations (whether or not due and payable) shall forthwith become due and payable by each Subsidiary Guarantor for the purpose of the
applicable Subsidiary Guarantee. 

         (c)  A
director, officer, employee or stockholder, as such, of an Subsidiary Guarantor shall not have any liability for any obligations of such Subsidiary Guarantor under
this Indenture or for any claim based on, in respect of or by reason of such obligations or their creation. 

        Section 13.2.    Limitation
of Subsidiary Guarantor's Liability. 

        Each
Subsidiary Guarantor and by its acceptance hereof each Holder of Securities hereby confirms that it is the intention of all such parties that the guarantee by such Subsidiary
Guarantor pursuant to its Subsidiary Guarantee not constitute a fraudulent transfer or conveyance for purposes of any federal, state or foreign law. To effectuate the foregoing intention, the Holders
of Securities and each Subsidiary Guarantor hereby irrevocably agree that the obligations of each Subsidiary Guarantor under its Subsidiary Guarantee shall be limited to the maximum amount as will,
after giving effect to all other contingent and fixed liabilities of such Subsidiary Guarantor and after giving effect to any collections from or payments made by or on behalf of any other Subsidiary
Guarantor in respect of the obligations
of such other Subsidiary Guarantor under its Subsidiary Guarantee, result in the obligations of such Subsidiary Guarantor under the Subsidiary Guarantee not constituting a fraudulent conveyance or
fraudulent transfer under federal, state or foreign law. 

        Section 13.3.    Contribution.

        In
order to provide for just and equitable contribution among the Subsidiary Guarantors, the Subsidiary Guarantors agree, inter se, that in the event any payment or distribution is made
by any Subsidiary Guarantor (a "Funding Guarantor") under the Subsidiary Guarantee, such Funding Guarantor shall be entitled to a contribution from each other Subsidiary Guarantor for all payments,
damages and expenses incurred by the Funding Guarantor in discharging the Company's obligations with respect to the Securities or any other Subsidiary Guarantor's obligations with respect to the
Subsidiary Guarantee. 

        Section 13.4.    Execution
and Delivery of Subsidiary Guarantees. 

        Each
Subsidiary Guarantor hereby agrees that its execution and delivery of this Indenture or any supplemental indentures pursuant to Article IX shall evidence its Subsidiary
Guarantee set forth in Section 13.1 without the need for any further notation on the Securities. 

        Each
of the Subsidiary Guarantors hereby agrees that its Subsidiary Guarantee set forth in Section 13.1 shall remain in full force and effect notwithstanding any failure to
endorse on each Security a notation relating to such Subsidiary Guarantee. 

39

 

        If
an Officer of a Subsidiary Guarantor whose signature is on this Indenture or any supplemental indenture no longer holds that office at the time the Trustee authenticates such
Securities or at any time thereafter, such Subsidiary Guarantor's Subsidiary Guarantee shall be valid nevertheless. 

        The
delivery of any Security by the Trustee, after the authentication thereof hereunder, shall constitute due delivery of any Subsidiary Guarantee set forth in this Indenture on behalf
of the Subsidiary Guarantor. 

        Section 13.5    Addition
of Subsidiary Guarantors. 

        Any
Person that was not a Subsidiary Guarantor on the date hereof may become a Subsidiary Guarantor by executing and delivering to the Trustee (A) a supplemental indenture in form
and substance satisfactory to the Trustee, which subjects such Person to the provisions (including the representations and warranties) of this Indenture as a Subsidiary Guarantor and (B) an
Opinion of Counsel and Officer's Certificate to the effect that such supplemental indenture has been duly authorized and executed by such Person and constitutes the legal, valid, binding and
enforceable obligation of such Person (subject to customary exceptions concerning creditor's rights and equitable principles as may be acceptable to the Trustee in its discretion and provided that no
opinion need be rendered concerning the enforceability of the Subsidiary Guarantee). 

        Section 13.6.    Severability.

        In
case any provision of this Subsidiary Guarantee shall be invalid, illegal or unenforceable, that portion of such provision that is not invalid, illegal or unenforceable shall remain
in effect, and the validity, legality, and enforceability of the remaining provisions shall not in any way be affected or impaired thereby. 

40

 

        IN
WITNESS WHEREOF, the parties hereto have caused this Indenture to be duly executed as of the day and year first above written. 

	 	 	SUPERIOR ESSEX INC.
	

 	
 	

By:	
 	

    

	 	 	Title:	 	 
	

 	
 	

THE BANK OF NEW YORK TRUST COMPANY, N.A.
	

 	
 	

By:	
 	

    

	 	 	Title:	 	 
	

 	
 	

SUBSIDIARY GUARANTORS, AS APPLICABLE
	

 	
 	

41

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EXHIBIT 4.9

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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	
 	

6
	

3.	
 	

EVALUATION AND CHOICE OF METHOD OF MANUFACTURE	
 	

8
	

4.	
 	

SUPPLY	
 	

11
	

5.	
 	

COMPLIANCE, QUALITY AND ENVIRONMENTAL	
 	

13
	

6.	
 	

MANUFACTURING CHANGES	
 	

17
	

7.	
 	

PRICE AND PAYMENT	
 	

18
	

8.	
 	

REPRESENTATIONS AND WARRANTIES	
 	

20
	

9.	
 	

INDEMNIFICATION AND INSURANCE	
 	

22
	

10.	
 	

TERM AND TERMINATION	
 	

24
	

11.	
 	

WYETH EQUIPMENT	
 	

26
	

12.	
 	

CONFIDENTIALITY	
 	

27
	

13.	
 	

FORCE MAJEURE	
 	

28
	

14.	
 	

INTELLECTUAL PROPERTY	
 	

28
	

15.	
 	

NOTICES	
 	

29
	

16.	
 	

GENERAL	
 	

30

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 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. 

[***]
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

 

        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, 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 

6

 

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. 

7

  

        (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 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. 

[***]
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

 

        3.4    Payment for Pre-Manufacture Work by ARMSTRONG.    

        (a)   WYETH
shall pay ARMSTRONG Five Hundred Thousand Dollars ($500,000) within [***]. This payment shall be credited as follows: 

	(i)
	If
WYETH elects to proceed with Option B, then [***]; or

	(ii)
	If
WYETH elects to proceed under Option A, then [***]. 

        (b)   If
WYETH elects to proceed with Option B, then [***]. 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) [***].

	(ii)
	Two
Hundred Thousand Dollars ($200,000) [***]. 

        (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. 

        (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. 

[***]
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. 

9

 

        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 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. 

[***]
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

 

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 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 

11

 

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 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. 

[***]
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    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 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. 

13

 

        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 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. 

14

 

        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);  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. 

[***]
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

 

        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, that any 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. 

[***]
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

  

	(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. 

        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   [***]  

        [***] to the [***], if [***] or
[***] of the [***] at [***] the [***] in [***] for [***]
to [***], with respect to [***] of [***] as well as [***] of [***] for so long
as [***] to [***] at [***] the [***], then [***] shall have the
[***] the [***] of this Section 7.5 [***] that [***] the [***] 

        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; 

[***]
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. 

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 

19

 

Product
under WYETH's NDA, any allegation that the WYETH's Technical Information infringes 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	 	[***] Per Occurrence

[***] Aggregate
	

Workers Compensation	
 	

Statutory with Employer's Liability of not less than [***] Per Accident/Disease
	

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

[***] 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. 

[***]
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. 

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 

22

 

consent.
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 

23

 

writing,
provided that such event of Force Majeure Event is continuing. If as 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. 

        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 

24

 

        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 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 

25

 

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 CONTENTS

APPENDIX 1: (Definition of Product)

EXHIBIT C Technology Transfer Plan for Primatene Mist ® and Costs

EXHIBIT E List of Equipment and Corrective Measures for Manufacture

EXHIBIT F Pre-launch Activities for Manufacture under ARMSTRONG's ANDA

EXHIBIT G Criteria for Water System

EXHIBIT H Adverse Experience Reporting Procedures—WYETH's NDA

EXHIBIT I Adverse Experience Reporting Procedures ARMSTRONG's ANDA

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