Document:

EX-4.4

 Exhibit 4.4 
  

 
  

CRINETICS PHARMACEUTICALS, INC. 
  

 
 INDENTURE

 Dated as of                     ,
20     
  
  

[                    ] 

Trustee 
  

 
  
  

 

 TABLE OF CONTENTS 

 

							
	 	  	 	  	Page	 
		
	 ARTICLE I. DEFINITIONS AND INCORPORATION BY REFERENCE

	  	 	1	 
	 Section 1.1.
	  	Definitions.	  	 	1	 
	 Section 1.2.
	  	Other Definitions.	  	 	4	 
	 Section 1.3.
	  	Incorporation by Reference of Trust Indenture Act.	  	 	5	 
	 Section 1.4.
	  	Rules of Construction.	  	 	5	 
		
	 ARTICLE II. THE SECURITIES 
	  	 	5	 
	 Section 2.1.
	  	Issuable in Series.	  	 	5	 
	 Section 2.2.
	  	Establishment of Terms of Series of Securities.	  	 	6	 
	 Section 2.3.
	  	Execution and Authentication.	  	 	8	 
	 Section 2.4.
	  	Registrar and Paying Agent.	  	 	9	 
	 Section 2.5.
	  	Paying Agent to Hold Money in Trust.	  	 	10	 
	 Section 2.6.
	  	Securityholder Lists.	  	 	10	 
	 Section 2.7.
	  	Transfer and Exchange.	  	 	10	 
	 Section 2.8.
	  	Mutilated, Destroyed, Lost and Stolen Securities.	  	 	11	 
	 Section 2.9.
	  	Outstanding Securities.	  	 	12	 
	 Section 2.10.
	  	Treasury Securities.	  	 	12	 
	 Section 2.11.
	  	Temporary Securities.	  	 	12	 
	 Section 2.12.
	  	Cancellation.	  	 	13	 
	 Section 2.13.
	  	Defaulted Interest.	  	 	13	 
	 Section 2.14.
	  	Global Securities.	  	 	13	 
	 Section 2.15.
	  	CUSIP Numbers.	  	 	15	 
		
	 ARTICLE III. REDEMPTION 
	  	 	15	 
	 Section 3.1.
	  	Notice to Trustee.	  	 	15	 
	 Section 3.2.
	  	Selection of Securities to be Redeemed.	  	 	15	 
	 Section 3.3.
	  	Notice of Redemption.	  	 	16	 
	 Section 3.4.
	  	Effect of Notice of Redemption.	  	 	16	 
	 Section 3.5.
	  	Deposit of Redemption Price.	  	 	17	 
	 Section 3.6.
	  	Securities Redeemed in Part.	  	 	17	 
		
	 ARTICLE IV. COVENANTS 
	  	 	17	 
	 Section 4.1.
	  	Payment of Principal and Interest.	  	 	17	 
	 Section 4.2.
	  	SEC Reports.	  	 	17	 
	 Section 4.3.
	  	Compliance Certificate.	  	 	18	 
	 Section 4.4.
	  	Stay, Extension and Usury Laws.	  	 	18	 
		
	 ARTICLE V. SUCCESSORS 
	  	 	18	 
	 Section 5.1.
	  	When Company May Merge, Etc.	  	 	18	 
	 Section 5.2.
	  	Successor Corporation Substituted.	  	 	19	 
		
	 ARTICLE VI. DEFAULTS AND REMEDIES 
	  	 	19	 
	 Section 6.1.
	  	Events of Default. 	  	 	19	 

  
 i 

							
	 	  	 	  	Page	 
	 Section 6.2.
	  	Acceleration of Maturity; Rescission and Annulment.	  	 	20	 
	 Section 6.3.
	  	Collection of Indebtedness and Suits for Enforcement by Trustee.	  	 	21	 
	 Section 6.4.
	  	Trustee May File Proofs of Claim.	  	 	22	 
	 Section 6.5.
	  	Trustee May Enforce Claims Without Possession of Securities.	  	 	22	 
	 Section 6.6.
	  	Application of Money Collected.	  	 	23	 
	 Section 6.7.
	  	Limitation on Suits.	  	 	23	 
	 Section 6.8.
	  	Unconditional Right of Holders to Receive Principal and Interest.	  	 	24	 
	 Section 6.9.
	  	Restoration of Rights and Remedies.	  	 	24	 
	 Section 6.10.
	  	Rights and Remedies Cumulative.	  	 	24	 
	 Section 6.11.
	  	Delay or Omission Not Waiver.	  	 	24	 
	 Section 6.12.
	  	Control by Holders.	  	 	24	 
	 Section 6.13.
	  	Waiver of Past Defaults.	  	 	25	 
	 Section 6.14.
	  	Undertaking for Costs.	  	 	25	 
		
	 ARTICLE VII. TRUSTEE 
	  	 	26	 
	 Section 7.1.
	  	Duties of Trustee.	  	 	26	 
	 Section 7.2.
	  	Rights of Trustee.	  	 	27	 
	 Section 7.3.
	  	Individual Rights of Trustee.	  	 	28	 
	 Section 7.4.
	  	Trustee’s Disclaimer.	  	 	28	 
	 Section 7.5.
	  	Notice of Defaults.	  	 	28	 
	 Section 7.6.
	  	Reports by Trustee to Holders.	  	 	29	 
	 Section 7.7.
	  	Compensation and Indemnity.	  	 	29	 
	 Section 7.8.
	  	Replacement of Trustee.	  	 	30	 
	 Section 7.9.
	  	Successor Trustee by Merger, Etc.	  	 	31	 
	 Section 7.10.
	  	Eligibility; Disqualification.	  	 	31	 
	 Section 7.11.
	  	Preferential Collection of Claims Against Company.	  	 	31	 
		
	 ARTICLE VIII. SATISFACTION AND DISCHARGE; DEFEASANCE

	  	 	31	 
	 Section 8.1.
	  	Satisfaction and Discharge of Indenture.	  	 	31	 
	 Section 8.2.
	  	Application of Trust Funds; Indemnification.	  	 	32	 
	 Section 8.3.
	  	Legal Defeasance of Securities of any Series.	  	 	33	 
	 Section 8.4.
	  	Covenant Defeasance.	  	 	34	 
	 Section 8.5.
	  	Repayment to Company.	  	 	35	 
	 Section 8.6.
	  	Reinstatement.	  	 	35	 
		
	 ARTICLE IX. AMENDMENTS AND WAIVERS 
	  	 	36	 
	 Section 9.1.
	  	Without Consent of Holders.	  	 	36	 
	 Section 9.2.
	  	With Consent of Holders.	  	 	37	 
	 Section 9.3.
	  	Limitations.	  	 	37	 
	 Section 9.4.
	  	Compliance with Trust Indenture Act.	  	 	38	 
	 Section 9.5.
	  	Revocation and Effect of Consents.	  	 	38	 
	 Section 9.6.
	  	Notation on or Exchange of Securities.	  	 	38	 
	 Section 9.7.
	  	Trustee Protected.	  	 	39	 
		
	 ARTICLE X. MISCELLANEOUS 
	  	 	39	 
	 Section 10.1.
	  	Trust Indenture Act Controls.	  	 	39	 
	 Section 10.2.
	  	Notices.	  	 	39	 

  
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	 	  	 	  	Page	 
	 Section 10.3.
	  	Communication by Holders with Other Holders.	  	 	40	 
	 Section 10.4.
	  	Certificate and Opinion as to Conditions Precedent.	  	 	40	 
	 Section 10.5.
	  	Statements Required in Certificate or Opinion.	  	 	41	 
	 Section 10.6.
	  	Rules by Trustee and Agents.	  	 	41	 
	 Section 10.7.
	  	Legal Holidays.	  	 	41	 
	 Section 10.8.
	  	No Recourse Against Others.	  	 	41	 
	 Section 10.9.
	  	Counterparts.	  	 	41	 
	 Section 10.10.
	  	Governing Law; Waiver of Jury Trial; Consent to Jurisdiction.	  	 	42	 
	 Section 10.11.
	  	No Adverse Interpretation of Other Agreements.	  	 	42	 
	 Section 10.12.
	  	Successors.	  	 	42	 
	 Section 10.13.
	  	Severability.	  	 	42	 
	 Section 10.14.
	  	Table of Contents, Headings, Etc.	  	 	43	 
	 Section 10.15.
	  	Securities in a Foreign Currency.	  	 	43	 
	 Section 10.16.
	  	Judgment Currency.	  	 	43	 
	 Section 10.17.
	  	Force Majeure.	  	 	44	 
	 Section 10.18.
	  	U.S.A. Patriot Act.	  	 	44	 
		
	 ARTICLE XI. SINKING FUNDS 
	  	 	44	 
	 Section 11.1.
	  	Applicability of Article.	  	 	44	 
	 Section 11.2.
	  	Satisfaction of Sinking Fund Payments with Securities.	  	 	45	 
	 Section 11.3.
	  	Redemption of Securities for Sinking Fund.	  	 	45	 

  
 iii 

 CRINETICS PHARMACEUTICALS, INC. 

Reconciliation and tie between Trust Indenture Act of 1939 and 

Indenture, dated as of                  
   , 20     
  

					
	§ 310(a)(1)	  		  	7.10
	(a)(2)	  		  	7.10
	(a)(3)	  		  	Not Applicable
	(a)(4)	  		  	Not Applicable
	(a)(5)	  		  	7.10
	(b)	  		  	7.10
	§ 311(a)	  		  	7.11
	(b)	  		  	7.11
	(c)	  		  	Not Applicable
	§ 312(a)	  		  	2.6
	(b)	  		  	10.3
	(c)	  		  	10.3
	§ 313(a)	  		  	7.6
	(b)(1)	  		  	7.6
	(b)(2)	  		  	7.6
	(c)(1)	  		  	7.6
	(d)	  		  	7.6
	§ 314(a)	  		  	4.2, 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
	§ 315(a)	  		  	7.1
	(b)	  		  	7.5
	(c)	  		  	7.1
	(d)	  		  	7.1
	(e)	  		  	6.14
	§ 316(a)	  		  	2.10
	(a)(1)(A)	  		  	6.12
	(a)(1)(B)	  		  	6.13
	(b)	  		  	6.8
	§ 317(a)(1)	  		  	6.3
	(a)(2)	  		  	6.4
	(b)	  		  	2.5
	§ 318(a)	  		  	10.1

  
 Note: This
reconciliation and tie shall not, for any purpose, be deemed to be part of the Indenture. 

  
 iv 

 Indenture dated as of
                    , 20     between Crinetics Pharmaceuticals, Inc., a company incorporated under the laws of Delaware
(“Company”), and [            ] (“Trustee”). 

Each party agrees as follows for the benefit of the other party and for the equal and ratable benefit of the Holders of the Securities issued
under this Indenture. 
 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 herein or 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
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 Notice Agent. 

“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 any day except a Saturday, Sunday or a legal holiday in The City of New York, New York (or in connection
with any payment, the place of payment) on which banking institutions are authorized or required by law, regulation or executive order to close. 

“Capital Stock” means any and all shares, interests, participations, rights or other equivalents (however designated) of
corporate stock. 
 “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 an Officer. 

 “Corporate Trust Office” means the office of the Trustee at which at any
particular time its corporate trust business related to this Indenture shall be principally administered. 
 “Default”
means any event which is, or after notice or passage of time or both would be, an Event of Default. 
 “Depositary” 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 Depositary for such Series by the Company, which Depositary shall be a clearing agency
registered under the Exchange Act; and if at any time there is more than one such person, “Depositary” as used with respect to the Securities of any Series shall mean the Depositary with respect to the Securities of such Series. 

“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” and
“$” means the currency of The United States of America. 
 “Exchange Act” means the Securities Exchange
Act of 1934, as amended. 
 “Foreign Currency” means any currency or currency unit issued by a government other than the
government of The United States of America. 
 “Foreign Government Obligations” means, with respect to Securities of any
Series that are denominated in a Foreign Currency, direct obligations of, or obligations guaranteed by, the government that issued or caused to be issued such currency for the payment of which obligations its full faith and credit is pledged and
which are not callable or redeemable at the option of the issuer thereof. 
 “GAAP” means accounting principles generally
accepted in the United States of America set forth in the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting
Standards Board or in such other statements by such other entity as have been approved by a significant segment of the accounting profession, which are in effect as of the date of determination. 

“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 Depositary for such Series or its nominee, and registered in the name of such Depositary or nominee. 

“Holder” or “Securityholder” means a person in whose name a Security is registered. 

  
 2 

 “Indenture” means this Indenture as amended or supplemented 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. 
 “Maturity,” when used with respect to any Security, means the date on which the principal of
such Security becomes due and payable as therein or herein provided, whether at the Stated Maturity or by declaration of acceleration, call for redemption or otherwise. 

“Officer” means the Chief Executive Officer, President, the Chief Financial Officer, the Treasurer or any Assistant
Treasurer, the Secretary or any Assistant Secretary, and any Vice President of the Company. 
 “Officer’s Certificate”
means a certificate signed by any 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. The opinion may contain customary limitations, conditions and exceptions. 

“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. 

“Responsible Officer” means any officer of the Trustee in its Corporate Trust Office having responsibility for administration
of this Indenture 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” means the debentures, notes or other debt instruments of the Company of any Series authenticated and delivered
under this Indenture. 
 “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. 
 “Stated Maturity” when used with
respect to any Security, means the date specified in such Security as the fixed date on which the principal of such Security or interest is due and payable. 

“Subsidiary” of any specified person means any corporation, association or other business entity of which more than 50% of
the total voting power of shares of Capital Stock entitled (without regard to the occurrence of any contingency) to vote in the election of directors, 

  
 3 

 
managers or trustees thereof is at the time owned or controlled, directly or indirectly, by such person or one or more of the other Subsidiaries of that person or a combination thereof. 

“TIA” means the Trust Indenture Act of 1939 (15 U.S. Code §§ 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. 

“U.S. Government Obligations” means securities which are direct obligations of, or guaranteed by, The United States of
America for the payment of which its full faith and credit is pledged and which are not callable or redeemable at the option of the issuer thereof, and shall also include a depositary receipt issued by a bank or trust company as custodian with
respect to any such U.S. Government Obligation or a specific payment of interest on or principal of any such U.S. Government Obligation held by such custodian for the account of the holder of a depository receipt, provided that (except as
required by law) such custodian is not authorized to make any deduction from the amount payable to the holder of such depositary receipt from any amount received by the custodian in respect of the U.S. Government Obligation evidenced by such
depositary receipt. 
 Section 1.2.    Other Definitions. 

 

					
	 TERM
	  	DEFINED IN
SECTION	 
	 “Bankruptcy Law”
	  	 	6.1	 
	 “Custodian”
	  	 	6.1	 
	 “Event of Default”
	  	 	6.1	 
	 “Judgment Currency”
	  	 	10.16	 
	 “Legal Holiday”
	  	 	10.7	 
	 “mandatory sinking fund payment”
	  	 	11.1	 
	 “New York Banking Day”
	  	 	10.16	 
	 “Notice Agent”
	  	 	2.4	 
	 “optional sinking fund payment”
	  	 	11.1	 
	 “Paying Agent”
	  	 	2.4	 
	 “Registrar”
	  	 	2.4	 
	 “Required Currency”
	  	 	10.16	 
	 “Specified Courts”
	  	 	10.10	 
	 “successor person”
	  	 	5.1	 

  
 4 

 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. 

“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 GAAP;

 (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. 

THE SECURITIES 
 
Section 2.1.    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 or determined in the manner provided in a Board Resolution, a
supplemental indenture or an Officer’s Certificate detailing the adoption of the terms thereof pursuant to authority granted under a Board 

  
 5 

 
Resolution. In the case of Securities of a Series to be issued from time to time, the Board Resolution, Officer’s Certificate or supplemental indenture detailing the adoption of the terms
thereof pursuant to authority granted under a Board Resolution 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
Subsection 2.2.1 and either as to such Securities within the Series or as to the Series generally in the case of Subsections 2.2.2 through 2.2.23) by or pursuant to a Board Resolution, and set forth or determined in the manner provided in a Board
Resolution, supplemental indenture hereto or Officer’s Certificate: 
 2.2.1.        the title
(which shall distinguish the Securities of that particular Series from the Securities of any other Series) and ranking (including the terms of any subordination provisions) of the Series; 

2.2.2.        the price or prices (expressed as a percentage of the principal amount thereof) at which
the Securities of the Series will be issued; 
 2.2.3.        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 2.7, 2.8, 2.11, 3.6 or 9.6); 
 2.2.4.        the date or dates on
which the principal of the Securities of the Series is payable; 
 2.2.5.        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; 
 2.2.6.        the place or places where the principal of and interest, if
any, on the Securities of the Series shall be payable, where the Securities of such Series may be surrendered for registration of transfer or exchange and where notices and demands to or upon the Company in respect of the Securities of such Series
and this Indenture may be delivered, and the method of such payment, if by wire transfer, mail or other means; 

2.2.7.        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; 

  
 6 

 2.2.8.        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 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; 

2.2.9.        the dates, if any, on which and the price or prices at which the Securities of the
Series will be repurchased by the Company at the option of the Holders thereof and other detailed terms and provisions of such repurchase obligations; 

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

2.2.12.        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; 

2.2.13.        the currency of denomination of the Securities of the Series, which may be Dollars or
any Foreign Currency, and if such currency of denomination is a composite currency, the agency or organization, if any, responsible for overseeing such composite currency; 

2.2.14.        the designation of the currency, currencies or currency units in which payment of the
principal of and interest, if any, on the Securities of the Series will be made; 

2.2.15.        if payments of principal of or interest, if any, on the Securities of the Series are to
be made in one or more currencies or currency units other than that or those in which such Securities are denominated, the manner in which the exchange rate with respect to such payments will be determined; 

2.2.16.        the manner in which the amounts of payment of principal of or interest, if any, on the
Securities of the Series will be determined, if such amounts may be determined by reference to an index based on a currency or currencies or by reference to a commodity, commodity index, stock exchange index or financial index; 

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

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

  
 7 

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

2.2.21.        the provisions, if any, relating to conversion or exchange of any Securities of such
Series, including if applicable, the conversion or exchange price, the conversion or exchange period, provisions as to whether conversion or exchange will be mandatory, at the option of the Holders thereof or at the option of the Company, the events
requiring an adjustment of the conversion price or exchange price and provisions affecting conversion or exchange if such Series of Securities are redeemed; 

2.2.22.        any other terms of the Series (which may supplement, modify or delete any provision of
this Indenture insofar as it applies to such Series), including any terms that may be required under applicable law or regulations or advisable in connection with the marketing of Securities of that Series; and 

2.2.23.        whether any of the Company’s direct or indirect Subsidiaries will guarantee the
Securities of that Series, including the terms of subordination, if any, of such guarantees. 
 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 hereto or Officer’s Certificate referred to above. 

Section 2.3.    Execution and Authentication. 

An Officer 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. 
 A Security shall not be valid until authenticated by the manual signature of the Trustee or an authenticating
agent. The signature shall be conclusive evidence that the Security has been authenticated under this Indenture. 
 The Trustee shall at any
time, and from time to time, authenticate Securities for original issue in the principal amount provided in the Board Resolution, supplemental indenture hereto or Officer’s Certificate, upon receipt by the Trustee of a Company Order. Each
Security shall be dated the date of its authentication. 
 The aggregate principal amount of Securities of any Series outstanding at any
time may not exceed any limit upon the maximum principal amount for such Series set forth in the Board Resolution, supplemental indenture hereto or Officer’s Certificate delivered pursuant to Section 2.2, except as provided in
Section 2.8. 

  
 8 

 Prior to the issuance of Securities of any Series, the Trustee shall have received and
(subject to Section 7.2) shall be fully protected in relying on: (a) the Board Resolution, supplemental indenture hereto or Officer’s Certificate establishing the form of the Securities of that Series or of Securities within that
Series and the terms of the Securities of that Series or of Securities within that Series, (b) an Officer’s Certificate complying with Section 10.4, and (c) an Opinion of Counsel complying with Section 10.4. 

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 be taken lawfully; or (b) if the Trustee in good faith by its board of directors or trustees, executive committee or a trust committee of directors and/or vice-presidents or a committee of
Responsible Officers 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 of
the Company. 
 Section 2.4.    Registrar and Paying Agent. 

The Company shall maintain, with respect to each Series of Securities, at the place or places specified with respect to such Series pursuant
to Section 2.2, 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 delivered (“Notice Agent”). The Registrar shall keep a register with respect
to each Series of Securities and to their transfer and exchange. 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 Notice Agent. If at any
time the Company shall fail to maintain any such required Registrar, Paying Agent or Notice 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; provided, however, that any appointment of the Trustee as the
Notice Agent shall exclude the appointment of the Trustee or any office of the Trustee as an agent to receive the service of legal process on the Company. 

The Company may also from time to time designate one or more co-registrars, additional paying agents
or additional notice 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 Notice 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 notice agent. The term “Registrar” includes any co-registrar; the term

  
 9 

 
“Paying Agent” includes any additional paying agent; and the term “Notice Agent” includes any additional notice agent. The Company or any of its Affiliates may
serve as Registrar or Paying Agent. 
 The Company hereby appoints the Trustee the initial Registrar, Paying Agent and Notice Agent for each
Series unless another Registrar, Paying Agent or Notice Agent, as the case may be, is appointed prior to the time Securities of that Series are first issued. 

Section 2.5.    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 in writing 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 of the Company) shall have no further liability for the money. If the Company or a Subsidiary of the Company 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. Upon any bankruptcy, reorganization or similar proceeding with respect to the Company, the Trustee shall serve as Paying
Agent for the Securities. 
 Section 2.6.    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 § 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 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 2.7.    Transfer and Exchange. 

Where Securities of a Series are presented to the Registrar or a co-registrar with a request to
register a transfer or to exchange them for an equal principal amount of Securities of the same Series, the Registrar shall register the transfer or make the exchange if its requirements for such transactions are met. To permit registrations of
transfers and exchanges, the Trustee shall authenticate Securities at the Registrar’s request. 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 2.11, 3.6 or
9.6). 
 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 

  
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business fifteen days immediately preceding the sending of a notice of redemption of Securities of that Series selected for redemption and ending at the close of business on the day such notice
is sent, 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 2.8.    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 bond as may be required by each of them to hold itself and any of its agents 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 receipt of a Company Order 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. 

Upon the issuance of any new Security under this Section, 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. 

  
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 Section 2.9.    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 2.8, 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 of the Company or an
Affiliate of the Company) 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. 
 The Company may purchase or otherwise acquire the Securities, whether by open market purchases, negotiated transactions or
otherwise. A Security does not cease to be outstanding because the Company or an Affiliate of the Company holds the Security (but see Section 2.10 below). 

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 2.10.    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 any Affiliate of the Company 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 a Responsible Officer of the Trustee knows are so owned shall be so disregarded. 

Section 2.11.    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 receipt of a Company Order 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. 

  
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Section 2.12.    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 the Trustee) and deliver a certificate of such cancellation to the Company upon written request of the Company. The Company may not issue new Securities to replace Securities that
it has paid or delivered to the Trustee for cancellation. 

Section 2.13.    Defaulted Interest. 

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 10 days before the special record
date, the Company shall send to the Trustee and to each Securityholder of the Series a notice that states the special 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 2.14.    Global Securities. 

2.14.1.        Terms of Securities. A Board Resolution, a supplemental indenture hereto or an
Officer’s 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 Depositary for such Global Security or Securities. 

2.14.2.        Transfer and Exchange. Notwithstanding any provisions to the contrary contained
in Section 2.7 of the Indenture and in addition thereto, any Global Security shall be exchangeable pursuant to Section 2.7 of the Indenture for Securities registered in the names of Holders other than the Depositary for such Security or
its nominee only if (i) such Depositary notifies the Company that it is unwilling or unable to continue as Depositary for such Global Security or if at any time such Depositary ceases to be a clearing agency registered under the Exchange Act,
and, in either case, the Company fails to appoint a successor Depositary registered as a clearing agency under the Exchange Act within 90 days of such event or (ii) the Company executes and delivers to the Trustee an Officer’s Certificate
to the effect that such Global Security shall be so exchangeable. Any Global Security that is exchangeable pursuant to the preceding sentence shall be exchangeable for Securities registered in such names as the Depositary 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 2.14.2, a Global Security may not be transferred except as a whole by the Depositary with respect to such Global Security to a nominee of such Depositary, by a nominee of such Depositary to such Depositary or another nominee of such
Depositary or by the Depositary or any such nominee to a successor Depositary or a nominee of such a successor Depositary. 

  
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 2.14.3.        Legends. 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 DEPOSITARY OR A NOMINEE OF THE DEPOSITARY. THIS SECURITY IS EXCHANGEABLE FOR SECURITIES REGISTERED IN THE NAME OF A PERSON OTHER THAN THE DEPOSITARY OR ITS NOMINEE ONLY IN
THE LIMITED CIRCUMSTANCES DESCRIBED IN THE INDENTURE, AND MAY NOT BE TRANSFERRED EXCEPT AS A WHOLE BY THE DEPOSITARY TO A NOMINEE OF THE DEPOSITARY, BY A NOMINEE OF THE DEPOSITARY TO THE DEPOSITARY OR ANOTHER NOMINEE OF THE DEPOSITARY OR BY THE
DEPOSITARY OR ANY SUCH NOMINEE TO A SUCCESSOR DEPOSITARY OR A NOMINEE OF SUCH A SUCCESSOR DEPOSITARY.” 
 In addition, so long as the
Depository Trust Company (“DTC”) is the Depositary, each Global Note registered in the name of DTC or its nominee shall bear a legend in substantially the following form: 

“UNLESS THIS GLOBAL NOTE IS PRESENTED BY AN AUTHORIZED REPRESENTATIVE OF THE DEPOSITORY TRUST COMPANY, A NEW YORK CORPORATION
(“DTC”), TO THE COMPANY OR ITS AGENT FOR REGISTRATION OF TRANSFER, EXCHANGE OR PAYMENT, AND ANY GLOBAL NOTE ISSUED IS REGISTERED IN THE NAME OF CEDE & CO. OR IN SUCH OTHER NAME AS IS REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF
DTC (AND ANY PAYMENT IS MADE TO CEDE & CO. OR TO SUCH OTHER ENTITY AS IS REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF DTC), ANY TRANSFER, PLEDGE OR OTHER USE HEREOF FOR VALUE OR OTHERWISE BY OR TO ANY PERSON IS WRONGFUL INASMUCH AS THE
REGISTERED OWNER HEREOF, CEDE & CO., HAS AN INTEREST HEREIN.” 

2.14.4.        Acts of Holders. The Depositary, 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. 

2.14.5.        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. 

2.14.6.        Consents, Declaration and Directions. 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 Depositary or by the applicable procedures of such Depositary
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. 

  
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 Section 2.15.    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 in writing of the
redemption date and the principal amount of Series of Securities to be redeemed. The Company shall give the notice at least 15 days before the redemption date, unless a shorter period is satisfactory 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 hereto or an Officer’s Certificate, if
less than all the Securities of a Series are to be redeemed, the Securities of the Series to be redeemed will be selected as follows: (a) if the Securities are in the form of Global Securities, in accordance with the procedures of the
Depositary, (b) if the Securities are listed on any national securities exchange, in compliance with the requirements of the principal national securities exchange, if any, on which the Securities are listed, or (c) if not otherwise
provided for under clause (a) or (b) in the manner that the Trustee deems fair and appropriate, including by lot or other method, unless otherwise required by law or applicable stock exchange requirements, subject, in the case of Global
Securities, to the applicable rules and procedures of the Depositary. The Securities to be redeemed shall be selected from Securities of the Series outstanding not previously called for redemption. Portions of the principal of Securities of the
Series that have denominations larger than $1,000 may be selected for redemption. Securities of the Series and portions of them it selected for redemption 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 2.2.10, the minimum principal denomination for each Series and the authorized 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. 

  
 15 

 Section 3.3.    Notice of
Redemption. 
 Unless otherwise indicated for a particular Series by Board Resolution, a supplemental indenture hereto or an
Officer’s Certificate, at least 15 days but not more than 60 days before a redemption date, the Company shall send or cause to be sent by first-class mail or electronically, in accordance with the procedures of the Depositary, a notice of
redemption to each Holder whose Securities are to be redeemed. 
 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)     if any Securities are being redeemed in part, the portion of the principal amount of such
Securities to be redeemed and that, after the redemption date and upon surrender of such Security, a new Security or Securities in principal amount equal to the unredeemed portion of the original Security shall be issued in the name of the Holder
thereof upon cancellation of the original Security; 
 (e)     that Securities of the Series called for
redemption must be surrendered to the Paying Agent to collect the redemption price; 
 (f)     that
interest on Securities of the Series called for redemption ceases to accrue on and after the redemption date unless the Company defaults in the deposit of the redemption price; 

(g)     the CUSIP number, if any; and 

(h)     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, provided, however, that the Company has delivered to the Trustee, at least 10 days (unless a shorter time shall be acceptable to the Trustee) prior to the notice date, an Officer’s Certificate requesting that the Trustee give such
notice and setting forth the information to be stated in such notice. 

Section 3.4.    Effect of Notice of Redemption. 

Once notice of redemption is sent 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. Except as otherwise provided in the supplemental indenture, Board Resolution or Officer’s Certificate for a Series, a notice of redemption may not be conditional. Upon

  
 16 

 
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 11:00 a.m., New York City time, on 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. On or before 11:00 a.m., New
York City time, on the applicable payment date, the Company shall deposit with the Paying Agent money sufficient to pay the principal of and interest, if any, on the Securities of each Series in accordance with the terms of such Securities and this
Indenture. 
 Section 4.2.    SEC Reports. 

To the extent any Securities of a Series are outstanding, 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 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 § 314(a). Reports, information and documents filed with the SEC via the EDGAR system will be deemed to be delivered to the Trustee
as of the time of such filing via EDGAR for purposes of this Section 4.2. 
 Delivery of reports, information and documents to the
Trustee under this Section 4.2 are for informational purposes only and the Trustee’s receipt of the foregoing shall not constitute constructive or actual notice of any information contained therein or determinable from information
contained therein, including the Company’s compliance with any of their covenants hereunder (as to which the Trustee is entitled to rely exclusively on Officer’s Certificates). 

  
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 Section 4.3.    Compliance
Certificate. 
 To the extent any Securities of a Series are outstanding, the Company shall deliver to the Trustee, within 120 days
after the end of each fiscal year of the Company, an Officer’s 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/her 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 the Officer may have knowledge). 

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. 
 ARTICLE V.

 SUCCESSORS 
 
Section 5.1.    When Company May Merge, Etc. 
 The Company shall not consolidate with or merge with or
into, or convey, transfer or lease all or substantially all of its properties and assets to, any person (a “successor person”) unless: 

(a)     the Company is the surviving corporation or the successor person (if other than the Company) is a
corporation organized and validly existing under the laws of any U.S. domestic jurisdiction and expressly assumes the Company’s obligations on the Securities and under this Indenture; and 

(b)     immediately after giving effect to the transaction, no Default or Event of Default, shall have
occurred and be continuing. 
 The Company shall deliver to the Trustee prior to the consummation of the proposed transaction an
Officer’s Certificate to the foregoing effect and an Opinion of Counsel stating that the proposed transaction and any supplemental indenture comply with this Indenture. 

  
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 Notwithstanding the above, any Subsidiary of the Company may consolidate with, merge into or
transfer all or part of its properties to the Company. Neither an Officer’s Certificate nor an Opinion of Counsel shall be required to be delivered in connection therewith. 

Section 5.2.    Successor Corporation Substituted. 

Upon any consolidation or merger, or any sale, lease, conveyance or other disposition of all or substantially all of the assets of the Company
in accordance with Section 5.1, the successor corporation formed by such consolidation or into or with which the Company is merged or to which such sale, lease, conveyance or other disposition 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 person has been named as the Company herein; provided, however, that the predecessor Company in the case of a sale,
conveyance or other disposition (other than a lease) shall be released 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,” wherever 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 Officer’s Certificate, it is provided that such Series shall not have the benefit of said Event
of Default: 
 (a)     default in 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 11:00 a.m., New York City time, on the 30th day of such period); or 
 (b)     default in the
payment of principal of any Security of that Series at its Maturity; or 
 (c)     default in the
performance or breach of any covenant or warranty of the Company in this Indenture (other than defaults pursuant to paragraphs (a) or (b) above or pursuant to a covenant or warranty that has been included in this Indenture solely for the
benefit of Series of Securities other than that Series), which default continues uncured for a period of 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; or

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

(i)    commences a voluntary case, 

  
 19 

 (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, 
 (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 

(e)     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 or for all or substantially all of its property, or 

(iii)    orders the liquidation of the Company, 

and the order or decree remains unstayed and in effect for 60 days; or 

(f)     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 Officer’s Certificate, in accordance with Section 2.2.18. 
 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. 
 The Company will provide the Trustee written notice of any Default or Event of Default within 30 days of becoming aware
of the occurrence of such Default or Event of Default, which notice will describe in reasonable detail the status of such Default or Event of Default and what action the Company is taking or proposes to take in respect thereof. 

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(d) or (e)) 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(d) or (e) shall occur, the principal amount (or specified amount) of and accrued and unpaid interest, if any, on all 

  
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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 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 all Events of Default with respect to Securities of that Series, other than the non-payment of the principal and interest, if any, 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. 
 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, if any, 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 and 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 compensation, reasonable 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

  
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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 compensation, reasonable 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
compensation, reasonable 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 compensation, reasonable 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. 

  
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 Section 6.6.    Application of
Money Collected. 
 Any money or property collected by the Trustee pursuant to this Article 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 or property 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 indemnity or security satisfactory to the
Trustee against the costs, expenses and liabilities which might be incurred by the Trustee 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, intended and expressly covenanted by the Holder of every Security with every other Holder and the Trustee 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 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, 

  
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except in the manner herein provided and for the equal and ratable benefit of all such Holders of the applicable Series. 

Section 6.8.    Unconditional Right of Holders to Receive Principal and
Interest. 
 Notwithstanding any other provision in this Indenture, the Holder of any Security shall have the right, which is absolute
and unconditional, to receive payment of the principal of and interest, if any, on such Security on the Maturity of such Security, including the Stated Maturity expressed in such Security (or, in the case of redemption, on the redemption date) and
to institute suit for the enforcement of any such payment, and such rights shall not be impaired without the consent of 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 2.8, 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, to the extent permitted
by law, 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 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, provided that 

  
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 (a)     such direction shall not be in conflict with any
rule of law or with this Indenture, 
 (b)     the Trustee may take any other action deemed proper by the
Trustee which is not inconsistent with such direction, 
 (c)     subject to the provisions of
Section 7.1, the Trustee shall have the right to decline to follow any such direction if the Trustee in good faith shall, by a Responsible Officer of the Trustee, determine that the proceeding so directed would involve the Trustee in personal
liability, and 
 (d)     prior to taking any action as directed under this Section 6.12, the
Trustee shall be entitled to indemnity satisfactory to it against the costs, expenses and liabilities which might be incurred by it in compliance with such request or direction. 

Section 6.13.    Waiver of Past Defaults. 

The Holders of not less than a majority in principal amount of the outstanding Securities of any Series may on behalf of the Holders of all
the Securities of such Series, by written notice to the Trustee and the Company, waive any past Default hereunder with respect to such Series and its consequences, except a Default in the payment of the principal of or interest on any Security of
such Series (provided, however, that the Holders of a majority in principal amount of the outstanding Securities of any Series may rescind an acceleration and its consequences, including any related payment default that resulted from such
acceleration). Upon any such waiver, such Default shall cease to exist, and any Event of Default arising therefrom shall be deemed to have been cured, for every purpose of this Indenture; but no such waiver shall extend to any subsequent or other
Default or impair any right consequent thereon. 
 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 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 Maturity of such Security, including the Stated Maturity expressed in such Security (or, in the case of redemption, on the redemption date). 

  
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 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 their exercise as a prudent person would exercise or use under the circumstances in the
conduct of such person’s 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. 
 (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 Officer’s Certificates or Opinions of Counsel furnished to the Trustee and conforming to the requirements of this Indenture; however, in
the case of any such Officer’s Certificates or Opinions of Counsel which by any provisions hereof are specifically required to be furnished to the Trustee, the Trustee shall examine such Officer’s Certificates and Opinions of Counsel to
determine whether or not they conform to the form 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 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 in accordance with Section 6.12. 

(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. 

  
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 (e)     The Trustee may refuse to perform any duty or
exercise any right or power unless it receives indemnity satisfactory to it against the costs, expenses and liabilities which might be incurred by it in performing such duty or exercising such right or power. 

(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 adequate indemnity against such risk is not assured to the Trustee in its satisfaction. 

(h)     The Paying Agent, the Registrar and any authenticating agent shall be entitled to the protections
and immunities as are set forth in paragraphs (e), (f) and (g) of this Section and in Section 7.2, each 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 (whether in its original or facsimile form) 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 Officer’s Certificate or an
Opinion of Counsel or both. The Trustee shall not be liable for any action it takes or omits to take in good faith in reliance on such Officer’s 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 Depositary shall be deemed an agent of the Trustee and the Trustee shall not be responsible for any act or omission by any Depositary. 

(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, provided that the Trustee’s conduct does not constitute willful misconduct or negligence. 

(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 without willful misconduct or negligence, 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 security or indemnity satisfactory to it against the costs, expenses and liabilities which might be incurred by it
in compliance with such request or direction. 

  
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 (g)     The Trustee shall not be bound to make any
investigation into the facts or matters stated in any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order, bond, debenture, note, other evidence of indebtedness or other paper or document, but
the Trustee, in its discretion, may make such further inquiry or investigation into such facts or matters as it may see fit. 

(h)     The Trustee shall not be deemed to have notice of any Default or Event of Default unless a
Responsible Officer of the Trustee has actual knowledge thereof or unless written notice of any event which is in fact such a default is received by the Trustee at the Corporate Trust Office of the Trustee, and such notice references the Securities
generally or the Securities of a particular Series and this Indenture. 
 (i)     In no event shall the
Trustee be liable to any person for special, punitive, indirect, consequential or incidental loss or damage of any kind whatsoever (including but not limited to lost profits), even if the Trustee has been advised of the likelihood of such loss or
damage. 
 (j)     The permissive right of the Trustee to take the actions permitted by this Indenture
shall not be construed as an obligation or duty to do so. 

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 of the Company 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. 

Section 7.4.    Trustee’s Disclaimer. 

The Trustee 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 in the Securities 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 send to each Securityholder of the Securities of that Series 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. 

  
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 Section 7.6.    Reports by
Trustee to Holders. 
 Within 60 days after each anniversary of the date of this Indenture, the Trustee shall transmit by mail to all
Securityholders, as their names and addresses appear on the register kept by the Registrar, a brief report dated as of such anniversary date, in accordance with, and to the extent required under, TIA § 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 national securities
exchange on which the Securities of that Series are listed. The Company shall promptly notify the Trustee in writing when Securities of any Series are listed on any national securities exchange. 

Section 7.7.    Compensation and Indemnity. 

The Company shall pay to the Trustee from time to time compensation for its services as the Company and the Trustee shall from time to time
agree upon in writing. 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 each of the Trustee and any predecessor Trustee (including for the cost of defending itself) against any cost, expense or liability, including taxes (other than taxes based upon, measured by or determined by the income of the Trustee)
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. Failure by the Trustee to
so notify the Company shall not relieve the Company of its obligations hereunder, unless and to the extent that the Company is materially prejudiced thereby. The Company shall defend the claim and the Trustee shall cooperate in the defense. The
Trustee may have one 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 will 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 incurred by the Trustee or by any officer, director, employee, shareholder or agent of the Trustee through willful misconduct or negligence. 

To secure the Company’s payment obligations in this Section, 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 of and interest on particular Securities of that Series. 

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

  
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 The provisions of this Section shall survive the termination of this Indenture. 

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. 
 The Trustee may resign with respect to the Securities of one or more Series by so
notifying the Company at least 30 days prior to the date of the proposed resignation. 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. 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 a bankrupt or an 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 a majority in principal amount of the Securities of the applicable Series may petition any court of competent jurisdiction for 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. 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
expenses and liabilities incurred by it for actions taken or omitted to be taken in accordance with its rights, powers and duties under this Indenture prior to such replacement. 

  
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 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, subject to Section 7.10. 

Section 7.10.    Eligibility; Disqualification. 

This Indenture shall always have a Trustee who satisfies the requirements of TIA § 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 § 310(b). 

Section 7.11.    Preferential Collection of Claims Against
Company. 
 The Trustee is subject to TIA § 311(a), excluding any creditor relationship listed in TIA § 311(b). A Trustee who
has resigned or been removed shall be subject to TIA § 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 be discharged with respect to the Securities of any Series and cease to be of further effect as to all
Securities of such Series (except as hereinafter provided in this Section 8.1), and the Trustee, at the expense of the Company, shall execute instruments acknowledging satisfaction and discharge of this Indenture, when 

(a)     either 

(i)    all Securities of such Series 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 of such Series not theretofore delivered to the Trustee for cancellation 

(1)    have become due and payable by reason of sending a notice of redemption or otherwise, or 

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

(3)    have been called for redemption or 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 

  
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 (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, shall have irrevocably deposited or caused to be deposited
with the Trustee as trust funds in trust an amount of money or U.S. Government Obligations, which amount shall be sufficient for the purpose of paying and discharging each installment of principal (including mandatory sinking fund or analogous
payments) of and interest on all the Securities of such Series on the dates such installments of principal or interest are due; 

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

(c)     the Company shall have delivered to the Trustee an Officer’s Certificate and an Opinion of
Counsel, each stating that all conditions precedent provided for relating to the satisfaction and discharge contemplated by this Section 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 2.4, 2.7, 2.8, 8.2 and 8.5 shall survive. 

Section 8.2.    Application of Trust Funds; Indemnification. 

(a)     Subject to the provisions of Section 8.5, all money and U.S. Government Obligations or Foreign
Government Obligations deposited with the Trustee pursuant to Section 8.1, 8.3 or 8.4 and all money received by the Trustee in respect of U.S. Government Obligations or Foreign Government Obligations deposited with the Trustee pursuant to
Section 8.1, 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 8.1, 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 U.S. Government Obligations or Foreign Government Obligations deposited pursuant to Sections 8.1, 8.3 or 8.4 or the interest and principal received in respect
of such 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 Order any U.S. Government Obligations or Foreign 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 or investment bank expressed in a written certification thereof delivered to the Trustee, are then in 

  
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excess of the amount thereof which then would have been required to be deposited for the purpose for which such U.S. Government Obligations or Foreign Government Obligations or money were
deposited or received. This provision shall not authorize the sale by the Trustee of any U.S. Government Obligations or Foreign 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 Section 2.2, 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 any Series on the 91st day after the date of the deposit referred to in subparagraph (d) 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, upon receipt of a Company Order, execute 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 (d) hereof, (i) payment of the principal of and each installment of principal of and interest on the outstanding Securities of such Series on the 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 2.4, 2.5, 2.7, 2.8, 7.7, 8.2, 8.3, 8.5 and 8.6; and 

(c)     the rights, powers, trusts and immunities of the Trustee hereunder and the Company’s
obligations in connection therewith; 
 provided that, the following conditions shall have been satisfied: 

(d)     the Company shall have irrevocably deposited or caused to be deposited (except as provided in
Section 8.2(c)) with the Trustee as trust funds specifically pledged as security for and dedicated solely to the benefit of the Holders of such Securities (i) in the case of Securities of such Series denominated in Dollars, cash in Dollars
and/or U.S. Government Obligations, or (ii) in the case of Securities of such Series denominated in a Foreign Currency (other than a composite currency), money and/or Foreign Government Obligations, which through the payment of interest and
principal in respect thereof in accordance with their terms, will provide (and without reinvestment and assuming no tax liability will be imposed on such Trustee), not later than one day before the due date of any payment of money, an amount in
cash, sufficient, in the opinion of a nationally recognized firm of independent public accountants or investment bank expressed in a written certification thereof delivered to the Trustee, to pay and discharge each installment of principal of and
interest, on and any mandatory sinking fund payments in respect of all the Securities of such Series on the dates such installments of principal or interest and such sinking fund payments are due; 

  
 33 

 (e)     such deposit will not result in a breach or
violation of, or constitute a default under, this Indenture or any other agreement or instrument to which the Company is a party or by which it is bound; 

(f)     no Default or Event of Default with respect to the Securities of such Series shall have occurred
and be continuing on the date of such deposit or during the period ending on the 91st day after such date; 

(g)     the Company shall have delivered to the Trustee an Officer’s Certificate and an Opinion of
Counsel to the effect that (i) the Company has received from, or there has been published by, the Internal Revenue Service a ruling, or (ii) since the date of execution of this Indenture, 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 shall confirm that, the Holders of the Securities of such Series will not recognize income, gain or loss for Federal income tax purposes as a result of such
deposit, defeasance and discharge and will be subject to Federal income tax on the same amount and in the same manner and at the same times as would have been the case if such deposit, defeasance and discharge had not occurred; 

(h)     the Company shall have delivered to the Trustee an Officer’s Certificate stating that the
deposit was not made by the Company with the intent of defeating, hindering, delaying or defrauding any other creditors of the Company; and 

(i)     the Company shall have delivered to the Trustee an Officer’s Certificate and an Opinion of
Counsel, each stating that all conditions precedent provided for relating to the defeasance contemplated by this Section have been complied with. 

Section 8.4.    Covenant Defeasance. 

Unless this Section 8.4 is otherwise specified pursuant to Section 2.2 to be inapplicable to Securities of any Series, the Company
may omit to comply with respect to the Securities of any Series with any term, provision or condition set forth under Sections 4.2, 4.3, 4.4 and 5.1 and, unless otherwise specified therein, any additional covenants specified in a supplemental
indenture for such Series of Securities or a Board Resolution or an Officer’s Certificate delivered pursuant to Section 2.2 (and the failure to comply with any such covenants shall not constitute a Default or Event of Default with respect
to such Series under Section 6.1) and the occurrence of any event specified in a supplemental indenture for such Series of Securities or a Board Resolution or an Officer’s Certificate delivered pursuant to Section 2.2 and designated
as an Event of Default shall not constitute a Default or Event of Default hereunder, with respect to the Securities of such Series, but, except as specified above, the remainder of this Indenture and such Securities will be unaffected thereby;
provided that the following conditions shall have been satisfied: 
 (a)     with reference to this
Section 8.4, the Company has irrevocably deposited or caused to be irrevocably deposited (except as provided in Section 8.2(c)) with the Trustee as trust funds in trust for the purpose of making the following payments specifically pledged
as security for, and dedicated solely to, the benefit of the Holders of 

  
 34 

 
such Securities (i) in the case of Securities of such Series denominated in Dollars, cash in Dollars and/or U.S. Government Obligations, or (ii) in the case of Securities of such Series
denominated in a Foreign Currency (other than a composite currency), money and/or Foreign Government Obligations, which through the payment of interest and principal in respect thereof in accordance with their terms, will provide (and without
reinvestment and assuming no tax liability will be imposed on such Trustee), not later than one day before the due date of any payment of money, an amount in cash, sufficient, in the opinion of a nationally recognized firm of independent certified
public accountants or investment bank expressed in a written certification thereof delivered to the Trustee, to pay and discharge each installment of principal (including mandatory sinking fund or analogous payments) of and interest on all the
Securities of such Series on the dates such installments of principal or interest are due; 
 (b)    
such deposit will not result in a breach or violation of, or constitute a default under, this Indenture or any other agreement or instrument to which the Company is a party or by which it is bound; 

(c)     no Default or Event of Default with respect to the Securities of such Series shall have occurred
and be continuing on the date of such deposit; 
 (d)     the Company shall have delivered to the Trustee
an Officers’ Certificate and an Opinion of Counsel to the effect that the Holders of the Securities of such Series will not recognize income, gain or loss for Federal income tax purposes as a result of such deposit and covenant defeasance and
will be subject to Federal income tax on the same amount and in the same manner and at the same times as would have been the case if such deposit and covenant defeasance had not occurred; 

(e)     The Company shall have delivered to the Trustee an Officer’s Certificate stating the deposit
was not made by the Company with the intent of defeating, hindering, delaying or defrauding any other creditors of the Company; and 

(f)     The Company shall have delivered to the Trustee an Officer’s Certificate and an Opinion of
Counsel, each stating that all conditions precedent herein provided for relating to the covenant defeasance contemplated by this Section have been complied with. 

Section 8.5.    Repayment to Company. 

Subject to applicable abandoned property law, 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. 
 Section 8.6.    Reinstatement. 

If the Trustee or the Paying Agent is unable to apply any money deposited with respect to Securities of any Series in accordance with
Section 8.1 by reason of any legal 

  
 35 

 
proceeding or by reason of any order or judgment of any court or governmental authority enjoining, restraining or otherwise prohibiting such application, the obligations of the Company under this
Indenture with respect to the Securities of such Series and under the Securities of such Series shall be revived and reinstated as though no deposit had occurred pursuant to Section 8.1 until such time as the Trustee or the Paying Agent is
permitted to apply all such money in accordance with Section 8.1; provided, however, that if the Company has made any payment of principal of or interest on or any Additional Amounts with respect to any Securities because of the
reinstatement of its obligations, the Company shall be subrogated to the rights of the Holders of such Securities to receive such payment from the money or U.S. Government Obligations held by the Trustee or Paying Agent after payment in full to the
Holders. 
 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 cure any ambiguity, defect or inconsistency; 
 (b)     to comply with Article V; 

(c)     to provide for uncertificated Securities in addition to or in place of certificated Securities;

 (d)     to add guarantees with respect to Securities of any Series or secure Securities of any Series;

 (e)     to surrender any of the Company’s rights or powers under this Indenture; 

(f)     to add covenants or events of default for the benefit of the holders of Securities of any Series;

 (g)     to comply with the applicable procedures of the applicable depositary; 

(h)     to make any change that does not adversely affect the rights of any Securityholder; 

(i)     to provide for the issuance of and establish the form and terms and conditions of Securities of any
Series as permitted by this Indenture; 
 (j)     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; or 

  
 36 

 (k)     to comply with requirements of the SEC in order
to effect or maintain the qualification of this Indenture under the TIA. 

Section 9.2.    With Consent of Holders. 

The Company and the Trustee may enter into a supplemental indenture with the written consent of the Holders of at least a majority in
principal amount of the outstanding Securities of each Series affected by such supplemental indenture (including consents obtained in connection with a tender offer or exchange offer for the Securities of such Series), for the purpose of adding any
provisions to or changing in any manner or eliminating any of the provisions of this Indenture or of any supplemental indenture or of modifying in any manner the rights of the Securityholders of each such Series. Except as provided in
Section 6.13, the Holders of at least a majority in principal amount of the outstanding Securities of any Series by notice to the Trustee (including consents obtained in connection with a tender offer or exchange offer for the Securities of
such Series) may waive compliance by the Company with any provision of this Indenture or the Securities with respect to such Series. 
 It
shall not be necessary for the consent of the Holders of Securities under this Section 9.2 to approve the particular form of any proposed supplemental indenture or waiver, but it shall be sufficient if such consent approves the substance
thereof. After a supplemental indenture or waiver under this section becomes effective, the Company shall send to the Holders of Securities affected thereby, a notice briefly describing the supplemental indenture or waiver. Any failure by the
Company to send such notice, or any defect therein, shall not, however, in any way impair or affect the validity of any such supplemental indenture or waiver. 

Section 9.3.    Limitations. 

Without the consent of each Securityholder affected, an amendment or waiver may not: 

(a)     reduce the principal amount of Securities whose Holders must consent to an amendment, supplement or
waiver; 
 (b)     reduce the rate of or extend the time for payment of interest (including default
interest) on any Security; 
 (c)     reduce the principal or change the Stated Maturity of any Security
or reduce the amount of, or postpone the date fixed for, the payment of any sinking fund or analogous obligation; 

(d)     reduce the principal amount of Discount Securities payable upon acceleration of the maturity
thereof; 
 (e)     waive a Default or Event of Default in the payment of the principal of or interest,
if any, on any Security (except a rescission of acceleration of the Securities of any Series by the Holders of at least a majority in principal amount of the outstanding Securities of such Series and a waiver of the payment default that resulted
from such acceleration); 

  
 37 

 (f)     make the principal of or interest, if any, on
any Security payable in any currency other than that stated in the Security; 
 (g)     make any change
in Sections 6.8, 6.13 or 9.3 (this sentence); or 
 (h)     waive a redemption payment with respect to
any Security, provided that such redemption is made at the Company’s option. 

Section 9.4.    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 9.5.    Revocation and Effect of
Consents. 
 Until an amendment is set forth in a supplemental indenture or a 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 of the supplemental indenture or the date the 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 (h) of Section 9.3. 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. 
 The Company may, but shall not be obligated to, fix a record date
for the purpose of determining the Holders entitled to give their consent or take any other action described above or required or permitted to be taken pursuant to this Indenture. If a record date is fixed, then notwithstanding the second
immediately preceding paragraph, those Persons who were Holders at such record date (or their duly designated proxies), and only those persons, shall be entitled to give such consent or to revoke any consent previously given or take any such action,
whether or not such Persons continue to be Holders after such record date. No such consent shall be valid or effective for more than 120 days after such record date. 

Section 9.6.    Notation on or Exchange of Securities. 

The Company or 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 receipt of a Company Order in accordance with Section 2.3 new Securities of that Series that reflect the amendment or waiver.

  
 38 

 Section 9.7.    Trustee
Protected. 
 In executing, or accepting the additional trusts created by, any supplemental indenture permitted by this Article 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 Officer’s Certificate or an Opinion of Counsel or both
complying with Section 10.4. The Trustee shall sign all supplemental indentures upon delivery of such an Officer’s Certificate or Opinion of Counsel or both, except that the Trustee need not sign any supplemental indenture that adversely
affects its rights, duties, liabilities or immunities under this Indenture. 
 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, or by a Holder to the Company or the Trustee, is duly given if in
writing and delivered in person or mailed by first-class mail (registered or certified, return receipt requested), facsimile transmission, email or overnight air courier guaranteeing next day delivery, to the
others’ address: 
 if to the Company: 

Crinetics Pharmaceuticals, Inc. 

10222 Barnes Canyon Road, Bldg. #2 

San Diego, CA 92121 
 Attention:
Chief Financial Officer 
 Telephone: (858) 450-6464 

with a copy to: 
 Latham & Watkins LLP

 12670 High Bluff Drive 

San Diego, CA 92130 
 Attention:
Cheston J. Larson 
 Telephone: (858) 523-5435 

if to the Trustee: 

[            ] 

  
 39 

 Attention: [            ] 

Telephone: [            ] 

with a copy to: 

[            ] 

Attention: [            ] 

Telephone: [            ] 

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 sent electronically or by first-class mail to his, her or its address shown on
the register kept by the Registrar, in accordance with the procedures of the Depositary. Failure to send 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 sent 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 sends a notice or communication to
Securityholders, it shall send a copy to the Trustee and each Agent at the same time. 
 Notwithstanding any other provision of this
Indenture or any Security, where this Indenture or any Security provides for notice of any event (including any notice of redemption) to a Holder of a Global Security (whether by mail or otherwise), such notice shall be sufficiently given to the
Depositary for such Security (or its designee) pursuant to the customary procedures of such Depositary. 

Section 10.3.    Communication by Holders with Other Holders. 

Securityholders of any Series may communicate pursuant to TIA § 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 § 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 Officer’s 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. 

  
 40 

 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 § 314(a)(4)) shall comply with the provisions of TIA § 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. 
 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 (past or present), 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. 

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. The exchange of copies of this Indenture and of signature pages by facsimile or PDF transmission shall constitute effective
execution and delivery of this Indenture as to the parties hereto and may 

  
 41 

 
be used in lieu of the original Indenture for all purposes. Signatures of the parties hereto transmitted by facsimile or PDF shall be deemed to be their original signatures for all purposes. 

Section 10.10.    Governing Law; Waiver of Jury Trial; Consent to
Jurisdiction. 
 THIS INDENTURE AND THE SECURITIES, INCLUDING ANY CLAIM OR CONTROVERSY ARISING OUT OF OR RELATING TO THE INDENTURE OR
THE SECURITIES, SHALL BE GOVERNED BY THE LAWS OF THE STATE OF NEW YORK. 
 THE COMPANY, THE TRUSTEE AND THE HOLDERS (BY THEIR
ACCEPTANCE OF THE SECURITIES) EACH HEREBY IRREVOCABLY WAIVE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS INDENTURE, THE NOTES OR THE TRANSACTIONS
CONTEMPLATED HEREBY OR THEREBY. 
 Any legal suit, action or proceeding arising out of or based upon this Indenture or the transactions
contemplated hereby may be instituted in the federal courts of the United States of America located in the City of New York or the courts of the State of New York in each case located in the City of New York (collectively, the “Specified
Courts”), and each party irrevocably submits to the non exclusive jurisdiction of such courts in any such suit, action or proceeding. Service of any process, summons, notice or document by mail (to the extent allowed under any applicable
statute or rule of court) to such party’s address set forth above shall be effective service of process for any suit, action or other proceeding brought in any such court. The Company, the Trustee and the Holders (by their acceptance of the
Securities) each hereby irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or other proceeding in the Specified Courts and irrevocably and unconditionally waive and agree not to plead or claim any such
suit, action or other proceeding has been brought in an inconvenient forum. 

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 of the Company. 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. 

  
 42 

 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. 

Section 10.15.    Securities in a Foreign Currency. 

Unless otherwise specified in a Board Resolution, a supplemental indenture hereto or an Officer’s Certificate delivered pursuant to
Section 2.2 of this Indenture with respect to a particular Series of Securities, whenever for purposes of this Indenture any action may be taken by the Holders of a specified percentage in aggregate principal amount of Securities of all Series
or all Series affected by a particular action at the time outstanding and, at such time, there are outstanding Securities of any Series which are denominated in more than one currency, then the principal amount of Securities of such Series which
shall be deemed to be outstanding for the purpose of taking such action shall be determined by converting any such other currency into a currency that is designated upon issuance of any particular Series of Securities. Unless otherwise specified in
a Board Resolution, a supplemental indenture hereto or an Officer’s Certificate delivered pursuant to Section 2.2 of this Indenture with respect to a particular Series of Securities, such conversion shall be at the spot rate for the
purchase of the designated currency as published in The Financial Times in the “Currency Rates” section (or, if The Financial Times is no longer published, or if such information is no longer available in The Financial Times, such source
as may be selected in good faith by the Company) on any date of determination. The provisions of this paragraph shall apply in determining the equivalent principal amount in respect of Securities of a Series denominated in currency other than
Dollars in connection with any action taken by Holders of Securities pursuant to the terms of this Indenture. 
 All decisions and
determinations provided for in the preceding paragraph shall, in the absence of manifest error, to the extent permitted by law, be conclusive for all purposes and irrevocably binding upon the Trustee and all Holders. 

Section 10.16.    Judgment Currency. 

The Company agrees, to the fullest extent that it may effectively do so under applicable law, that (a) if for the purpose of obtaining
judgment in any court it is necessary to convert the sum due in respect of the principal of or interest or other amount on the Securities of any Series (the “Required Currency”) into a currency in which a judgment will be rendered
(the “Judgment Currency”), the rate of exchange used shall be the rate at which in accordance with normal banking procedures the Trustee could purchase in The City of New York the Required Currency with the Judgment Currency on the
day on which final unappealable judgment is entered, unless such day is not a New York Banking Day, then the rate of exchange used shall be the rate at which in accordance with normal banking procedures the Trustee could purchase in The City of New
York the Required Currency with the Judgment Currency on the New York Banking Day preceding the day on which final unappealable judgment is entered and (b) its obligations under this Indenture to make payments in the Required Currency
(i) shall not be discharged or satisfied by any tender, any recovery pursuant to any judgment (whether or not 

  
 43 

 
entered in accordance with subsection (a)), in any currency other than the Required Currency, except to the extent that such tender or recovery shall result in the actual receipt, by the payee,
of the full amount of the Required Currency expressed to be payable in respect of such payments, (ii) shall be enforceable as an alternative or additional cause of action for the purpose of recovering in the Required Currency the amount, if
any, by which such actual receipt shall fall short of the full amount of the Required Currency so expressed to be payable, and (iii) shall not be affected by judgment being obtained for any other sum due under this Indenture. For purposes of
the foregoing, “New York Banking Day” means any day except a Saturday, Sunday or a legal holiday in The City of New York on which banking institutions are authorized or required by law, regulation or executive order to close. 

Section 10.17.    Force Majeure. 

In no event shall the Trustee be responsible or liable for any failure or delay in the performance of its obligations hereunder arising out of
or caused by, directly or indirectly, forces beyond its control, including, without limitation, strikes, work stoppages, accidents, acts of war or terrorism, civil or military disturbances, nuclear or natural catastrophes or acts of God, and
interruptions, loss or malfunctions of utilities, communications or computer (software and hardware) services, it being understood that the Trustee shall use reasonable best efforts which are consistent with accepted practices in the banking
industry to resume performance as soon as practicable under the circumstances. 

Section 10.18.    U.S.A. Patriot Act. 

The parties hereto acknowledge that in accordance with Section 326 of the U.S.A. Patriot Act, the Trustee is required to obtain, verify,
and record information that identifies each person or legal entity that establishes a relationship or opens an account with the Trustee. The parties to this Indenture agree that they will provide the Trustee with such information as it may request
in order for the Trustee to satisfy the requirements of the U.S.A. Patriot Act. 
 ARTICLE XI. 

SINKING FUNDS 
 
Section 11.1.    Applicability of Article. 
 The provisions of this Article shall be applicable to any
sinking fund for the retirement of the Securities of a Series if so provided by the terms of such Securities pursuant to Section 2.2 and 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. 

  
 44 

 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 credit Securities of such Series to which such sinking fund payment is applicable and which have been repurchased by the Company or 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 Officer’s 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 Officer’s 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 Officer’s 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, Officer’s Certificate or supplemental indenture in respect of a particular Series of Securities) before each such sinking fund payment date the Securities to be redeemed upon such sinking
fund payment date will be selected in the manner specified in Section 3.2 and the Company shall send or cause to be sent a notice of the redemption thereof to be given in the name of and at the expense of the Company in the manner provided in
and in accordance with 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. 

  
 45 

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

			
	CRINETICS PHARMACEUTICALS, INC.

 
			
		
	By:	 	  

 
			
		 	Name:
		 	Its:
	
	[            ], as Trustee

 
			
		
	By:	 	  

 
			
		 	Name:
		 	Its:Exhibit 10.1

 

CERTAIN INFORMATION IDENTIFIED WITH
THE MARK “(***)”, “(***%***)” AND “(***$***)” HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE SUCH
INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 

 

Execution Version

 

 

EXCLUSIVE
license AGREEMENT

 

by and between

 

OSI
pharmaCEUTICALS, llc

 

and

 

Aevi
Genomic Medicine, Inc.

 

July 15, 2019

 

     

     

    

  

EXCLUSIVE
LICENSE AGREEMENT

 

This Exclusive License
Agreement (this “Agreement”) is entered into as of July 15, 2019 (the “Effective Date”),
by and between OSI Pharmaceuticals, LLC, a limited liability company organized under the laws of the State of Delaware, having
an address of 1 Astellas Way, Northbrook, IL 60062 (“OSI”), and Aevi Genomic Medicine, a corporation organized
under the laws of the State of Delaware, having an address of 435 Devon Park Drive, Suite 715, Wayne, PA 19087 (“Licensee”).
OSI and Licensee may each be referred to herein individually as a “Party” and collectively as the “Parties.”

 

WHEREAS, OSI
wishes to grant to Licensee, and Licensee wishes to receive from OSI, an exclusive license under the OSI Product IP in the Field
in the Territory to develop, manufacture and commercialize Licensed Products.

 

NOW THEREFORE,
in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

 

		1.	DEFINITIONS

 

As used in this Agreement,
the following terms will have the meanings set forth below:

 

1.1.       “Affiliate”
means, with respect to any Person, any entity directly or indirectly controlled by, controlling, or under common control with,
such Person, but only for so long as such control continues. For purposes of this definition, “control” (including,
with correlative meanings, “controlled by”, “controlling” and “under common control with”)
means (a) possession, direct or indirect, of the power to direct or cause the direction of the management or policies of an entity
(whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial ownership of
more than fifty percent (50%) (or the maximum ownership interest permitted by Applicable Law) of the voting securities or other
ownership or general partnership interest (whether directly or pursuant to any option, warrant or other similar arrangement) or
other comparable equity interests of an entity; provided, however, that where an entity owns a majority of the voting
power necessary to elect a majority of the board of directors or other governing board of another entity, but is restricted from
electing such majority by contract or otherwise, such entity will not be considered to be in control of such other entity until
such time as such restrictions are no longer in effect.

 

1.2.       “Agreement”
has the meaning set forth in the Preamble.

 

1.3.       “Applicable
Law” means collectively all laws, regulations, ordinances, decrees, judicial and administrative orders (and any
license, franchise, permit, or similar right granted under any of the foregoing), and any policies and other requirements of any
applicable Governmental Authority that govern or otherwise apply to a Party’s activities in connection with this Agreement.

 

1.4.       “Bankruptcy
Code” means Section 101(35A) of Title 11 of the United States Code, as amended.

 

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1.5.       “Breaching
Party” has the meaning set forth in Section 8.6.

 

1.6.       “Business
Day” means a day other than a Saturday, Sunday or a day that is a statutory, bank or other public holiday in New
York, New York, USA.

 

1.7.       “Calendar
Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September
30 and December 31; provided that the first Calendar Quarter of the Term shall begin on the Effective Date and end on the
first to occur of March 31, June 30, September 30 and December 31 and the last Calendar Quarter shall end on the last day of the
Term.

 

1.8.       “Calendar
Year” means any twelve (12) month period beginning on January 1 and ending on the next subsequent December 31;
provided that the first Calendar Year of the Term shall begin on the Effective Date and end on December 31, 2019 and the
last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.

 

1.9.       “Change
of Control” means, with respect to a Party (a) the acquisition of beneficial ownership, directly or indirectly,
by any Person (other than such Party or an Affiliate of such Party, and other than by virtue of obtaining irrevocable proxies)
of securities or other voting interest of such Party representing a majority or more of the combined voting power of such Party’s
then outstanding securities or other voting interests, (b) any merger, reorganization, consolidation or business combination involving
such Party with a Third Party that results in the holders of beneficial ownership (other than by virtue of obtaining irrevocable
proxies) of the voting securities or other voting interests of such Party (or, if applicable, the ultimate parent of such Party)
immediately prior to such merger, reorganization, consolidation or business combination ceasing to hold beneficial ownership of
at least (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation
or business combination, (c) any sale, lease, exchange, contribution or other transfer (in one transaction or a series of related
transactions) of all or substantially all of the assets of such Party to which this Agreement relates, other than a sale or disposition
of such assets to an Affiliate of such Party or (d) the approval of any plan or proposal for the liquidation or dissolution of
such Party.

 

1.10.       “Clinical
Trial” means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a)
establish that a product is reasonably safe for continued testing, (b) investigate the safety and efficacy of a product for its
intended use and to define warnings, precautions and adverse reactions that may be associated with a product in the dosage range
to be prescribed or (c) support or maintain Regulatory Approval of such product or label expansion of such product.

 

1.11.       “Commercialization”
means any and all activities directed to the marketing, promotion, distribution, pricing, reimbursement, offering for sale, and
sale of a product and interacting with Regulatory Authorities following receipt of Regulatory Approval in the applicable country
or region for such product regarding the foregoing, but excluding activities directed to Manufacturing or Development. “Commercialize,”
“Commercializing,” and “Commercialized” will be construed accordingly.

 

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1.12.       “Commercially
Reasonable Efforts” means the utilization by Licensee of such reasonable and good faith efforts in the research,
development, pursuit of regulatory approvals for, Development, Manufacture and Commercialization of Licensed Product as, in each
case, are consistent with the efforts pharmaceutical companies typically devote to exploitation of a product at a similar stage
in its product life as Licensed Product and having profit potential and strategic value comparable to that of such Licensed Product,
taking into account, without limitation, commercial, legal and regulatory factors, target product profiles, product labeling, the
regulatory environment and competitive market conditions in the therapeutic area, safety and efficacy of such Licensed Product,
the strength of its proprietary position and such other factors as Licensee may reasonably consider, all based on conditions then
prevailing.

 

1.13.       “Competing
Infringement” has the meaning set forth in Section 5.2.2.

 

1.14.       “Compound”
means all presentations of the molecule designated by OSI as ASP7486 (OSI-027) and having the molecular structure set forth in
Schedule 3.

 

1.15.       “Confidential
Information” means, with respect to each Party, all Know-How or other information, including proprietary information
and materials (whether or not patentable) regarding or embodying such Party’s technology, products, business information
or objectives, that is communicated by or on behalf of the Disclosing Party to the Receiving Party or its permitted recipients
before, on or after the Effective Date, including any such information that was disclosed by a Party or any of its Affiliates under
the Prior CDA. Confidential Information does not include any Know-How or other information that, to the extent shown by reasonable
documentary evidence, (a) was already known by the Receiving Party (other than under an obligation of confidentiality, including
to the Disclosing Party) at the time of disclosure by or on behalf of the Disclosing Party, (b) was generally available to the
public or otherwise part of the public domain at the time of its disclosure to the Receiving Party, (c) became generally available
to the public or otherwise part of the public domain after its disclosure to the Receiving Party, other than through any act or
omission of the Receiving Party in breach of its obligations to the Disclosing Party or any of its Affiliates, including under
the Prior CDA or under this Agreement, (d) was disclosed to the Receiving Party, other than under an obligation of confidentiality,
by a Third Party who had no obligation to the Disclosing Party or any of its Affiliates not to disclose such information to the
Receiving Party or (e) was independently discovered or developed by or on behalf of the Receiving Party without access to or the
use of any Confidential Information belonging to the Disclosing Party. The terms and conditions of this Agreement will be considered
Confidential Information of both Parties.

 

1.16.       “Control”
or “Controlled” means with respect to any Know-How, Patent or other intellectual property right (including any
data, information or material), the ability to grant a license, sublicense or other right to or under such Know-How, Patent or
other intellectual property right as provided for herein without (a) violating the terms of any agreement or other arrangement
with any Third Party, (b) incurring any payment obligation to a Third Party or (c) violating any Applicable Law.

 

1.17.       “Cover”
means, with respect to a given product and Patent, that a claim of such Patent would (and in the case of a pending claim, would
if issued), absent a license thereunder or ownership thereof, be infringed by the manufacture, use, sale or offer for sale of such
product.

 

    	 	3	 

     

    

 

1.18.       “Defense
Action” means (a) initiation by a Third Party of (i) a challenge to the validity, scope, or enforceability of
any OSI Product Patent, or (ii) an opposition proceeding against any OSI Product Patent, (b) initiation by Licensee of an opposition
against a Third Party, or (c) any allegation by a Third Party that the intellectual property owned by it is infringed, misappropriated,
or violated by the exploitation of any Licensed Product.

 

1.19.       “Development”
means all internal and external research, development, and regulatory activities related to products, including (a) research,
non-clinical testing, toxicology, testing and studies, non-clinical and preclinical activities, and Clinical Trials, and (b) preparation,
submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization
to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of a product, but excluding activities directed
to Manufacturing or Commercialization. Development will include development and regulatory activities for additional forms, formulations,
or indications for a product after receipt of Regulatory Approval of such product (including label expansion), including Clinical
Trials initiated following receipt of Regulatory Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval
that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved
formulation or indication (such as post-marketing studies and observational studies, if required by any Regulatory Authority in
any region in the Territory to support or maintain Regulatory Approval for a product in such region). “Develop,”
“Developing,” and “Developed” will be construed accordingly.

 

1.20.       “Development
Plan” means the written development plan attached hereto as Schedule 4.

 

1.21.       “Disclosing
Party” has the meaning set forth in Section 6.1.

 

1.22.       “Dollar”
means the U.S. dollar, and “$” will be interpreted accordingly.

 

1.23.       “Drug
Material” has the meaning set forth in Section 4.3.2.

 

1.24.       “Effective
Date” has the meaning set forth in the Preamble.

 

1.25.       “European
Union” or “EU” means, with respect to any given time, all countries who are members of the
European Union as of the Effective Date; provided that, notwithstanding anything to the contrary in this Agreement, the
United Kingdom will be deemed a part of the European Union for the purposes of this Agreement.

 

1.26.       “Existing
IND” has the meaning set forth in Section 2.4.1(b).

 

1.27.       “FD&C
Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated
thereunder.

 

1.28.       “FDA”
means the United States Food and Drug Administration or any successor agency thereto.

 

1.29.       “Field”
means the diagnosis, prevention, prophylaxis, treatment, cure, or palliative care of disease, disorder or condition in humans or
animals.

 

    	 	4	 

     

    

  

1.30.       “First
Commercial Sale” means, with respect to any Licensed Product in any country or region, the first sale of such
Licensed Product, by or on behalf of Licensee (including by any of its Affiliates or Sublicensees), in an arms-length transaction
to a Third Party (other than a Sublicensee) for distribution, use, or consumption in such country or region after receipt of Regulatory
Approval for such Licensed Product in such country or region. For the avoidance of doubt, “First Commercial Sale”
excludes any transfers of Licensed Product to Third Parties for testing purposes, any expanded access program, any compassionate
sales or use program (including named patient program or single patient program), or any indigent program; provided that, in each
case, such Licensed Product is provided at no charge and not sold in connection (e.g., as a bundle or another type of direct or
indirect bundling arrangement) with any other product of Licensee, its Affiliates or Sublicensees in which consideration is charged
for such Licensed Product.

 

1.31.       “GAAP”
means United States generally accepted accounting principles, consistently applied.

 

1.32.       “Governmental
Authority” means any federal, state, national, state, provincial, or local government, or political subdivision
thereof, or any multinational organization or any authority, agency, or commission entitled to exercise any administrative, executive,
judicial, legislative, police, regulatory or taxing authority or power, or any court or tribunal (or any department, bureau or
division thereof, or any governmental arbitrator or arbitral body). Governmental Authorities include all Regulatory Authorities.

 

1.33.       “IND”
means an Investigational New Drug application required pursuant to 21 C.F.R. Part 312 or any comparable filings outside of the
U.S. required to commence human clinical trials in such country or region, and all supplements or amendments that may be filed
with respect to the foregoing.

 

1.34.       “Indemnified
Party” has the meaning set forth in Section 9.4.

 

1.35.       “Indemnifying
Party” has the meaning set forth in Section 9.4.

 

1.36.       “Infringement”
has the meaning set forth in Section 5.2.2.

 

1.37.       “Initial
Signal Finding Study” has the meaning set forth in Section 4.1.3(a).

 

1.38.       “Initiating
Party” has the meaning set forth in Section 5.2.3.

 

1.39.       “Know-How”
means any proprietary information and materials, including records, discoveries, improvements, modifications, processes, techniques,
methods, assays, chemical or biological materials, designs, protocols, formulas, data (including physical data, chemical data,
toxicology data, animal data, raw data, clinical data, and analytical and quality control data), dosage regimens, control assays,
product specifications, marketing, pricing and distribution costs, inventions, algorithms, technology, forecasts, profiles, strategies,
plans, results in any form whatsoever, know-how and trade secrets (in each case, whether or not patentable or copyrightable).

 

1.40.       “Liability”
has the meaning set forth in Section 9.1.

 

    	 	5	 

     

    

  

1.41.       “Licensed
Product” means any pharmaceutical product comprised of or containing a Compound as an active pharmaceutical ingredient,
in all forms, presentations, formulations and dosage forms including all stereoisomers, diastereomers, optical stereoisomers, enantiomers,
hydrates and solvates, anhydrous and non-solvated forms, tautomeric forms, salts, crystalline forms, polymorphic forms, N-oxides,
or prodrugs thereof.

 

1.42.       “Licensee”
has the meaning set forth in the Preamble.

 

1.43.       “Licensee
Abandoned Patent” has the meaning set forth in Section 5.2.1.

 

1.44.       “Licensee
Indemnified Party” has the meaning set forth in Section 9.3.

 

1.45.       “Licensee
Product Technology” has the meaning set forth in Section 8.7.5.

 

1.46.       
“Manufacture” means activities directed to manufacturing,
processing, packaging, labeling, filling, finishing, assembly, quality assurance, quality control, testing, and release, shipping,
or storage of any product (or any components or process steps involving any product or any companion diagnostic), placebo, or comparator
agent, as the case may be, including process development, qualification, and validation, scale-up, pre-clinical, clinical, and
commercial manufacture and analytic development, product characterization, and stability testing, but excluding activities directed
to Development or Commercialization. “Manufacturing” and “Manufactured” will be construed
accordingly.

 

1.47.       “Milestone
Event” has the meaning set forth in Section 3.2.

 

1.48.       “Milestone
Payment” has the meaning set forth in Section 3.2.

 

1.49.       “NDA”
means a New Drug Application submitted to the FDA in the United States in accordance with the FD&C Act with respect to a pharmaceutical
product or any analogous application or submission with any Regulatory Authority outside of the United States.

 

1.50.       “Net
Sales” means, with respect to the sale of Licensed Product, the gross amounts invoiced by Licensee or any of its
Affiliates or Sublicensees to Third Parties for sales of such Licensed Product throughout the Territory, less the following deductions
actually incurred, allowed, paid, accrued or otherwise specifically allocated to the sale of Licensed Product by Licensee or any
of its Affiliates or Sublicensees using GAAP applied on a consistent basis:

 

1.50.1.       customary
trade, quantity, or cash discounts, chargebacks and rebates to the extent actually allowed and taken;

 

1.50.2.       amounts
repaid or credited by reason of rejection or return;

 

1.50.3.       customs
or excise duties, sales tax, consumption tax, value added tax, and other taxes (except income taxes) or duties relating to sales
of such Licensed Product that are not reimbursable; and

 

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1.50.4.       outbound
shipping or transportation costs prepaid or allowed and costs of insurance in transit (to the extent that Licensee, any of its
Affiliates or any of its Sublicensees bear such costs for such Licensed Product).

 

Net Sales shall not
include sales to Affiliates, Sublicensees or contractors engaged by Licensee to develop, promote, co-promote, market, sell or otherwise
distribute Licensed Product, solely to the extent that such Affiliate, Sublicensees or contractor purchasing the Licensed Product
resells such Licensed Product to a Third Party. However, subsequent sales of Licensed Product by such Licensee Affiliates, Sublicensees
or contractors to a Third Party shall be included in Net Sales when sold in the market. In no event shall any particular amount
identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of reductions).

 

In the event that
Licensed Product is sold as part of a financial bundle with other products or is included in financial package deals to customers,
the price of the Licensed Product to be included for the purpose of calculating Net Sales will be the average invoiced sales price
of Licensed Product sold separately in the preceding Calendar Quarter less the average discount of all products sold as part of
such bundle or package.

 

1.51.       “Non-Breaching
Party” has the meaning set forth in Section 8.6.

 

1.52.       “OSI”
has the meaning set forth in the Preamble.

 

1.53.       “OSI
Indemnified Party” has the meaning set forth in Section 9.1.

 

1.54.       “OSI
Product IP” means the OSI Product Patents and the OSI Product Know-How.

 

1.55.       “OSI
Product Know-How” means all Know-How (a) Controlled by OSI or any of its Affiliates as of the Effective Date,
(b) exclusively related to the Compound, and (c) necessary for the Development, Manufacture, use or Commercialization of the Compound
including all such Know-How listed on Schedule 1.

 

1.56.       “OSI
Product Patents” means the issued Patents set forth on Schedule 2.

 

1.57.       “OSI’s
Knowledge” means the actual knowledge as of the Effective Date, without
any inquiry or investigation, of Masato Kishida and Mayuko Miura.

 

1.58.       “Party”
or “Parties” has the meaning set forth in the Preamble.

 

1.59.       “Patent
Challenge” means any direct or indirect challenge to the validity, patentability, scope, construction, inventorship,
ownership, enforceability or non-infringement of any OSI Product Patent or otherwise opposing any OSI Product Patent through a
legal or administrative proceeding.

 

    	 	7	 

     

    

  

1.60.       “Patents”
means (a) all patents and patent applications in any country or region, (b) all patent applications filed either from such
patents or patent applications or from an application claiming priority from any of these, including divisionals, continuations,
continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all patents that
have issued or in the future issue from the foregoing patent applications, and (d) any and all substitutions, renewals, registrations,
confirmations, extensions, or restorations, including revalidations, reissues, and re-examinations (including any supplementary
protection certificates and the like) of the foregoing patents or patent applications.

 

1.61.       “Person”
means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization,
including a government or political subdivision or department or agency of a government.

 

1.62.       “Prior
CDA” means that certain Mutual Confidential Disclosure Agreement dated as of March 14, 2018, by and between Licensee
and OSI.

 

1.63.       “Receiving
Party” has the meaning set forth in Section 6.1.

 

1.64.       “Regulatory
Approval” means, with respect to a particular country or other regulatory jurisdiction, any approval of an NDA,
marketing application or other approval, product, or establishment license, registration, or authorization of any Regulatory Authority
necessary for the commercial marketing or sale of a product in such country or other regulatory jurisdiction.

 

1.65.       “Regulatory
Authority” means any applicable Governmental Authority responsible for granting Regulatory Approvals for products
in a particular country or other regulatory jurisdiction and any corresponding national or regional regulatory authorities.

 

1.66.       “Regulatory
Documentation” means, with respect to any Licensed Product in any jurisdiction, any and all regulatory applications,
filings, approvals, and associated correspondence required to develop, manufacture, market, sell, and import such Licensed Product
in, or into, any jurisdiction, including, for clarity, all Regulatory Approvals necessary for the sale of such Licensed Product
in a given jurisdiction in accordance with all Applicable Laws.

 

1.67.       “Regulatory
Transfer” has the meaning set forth in Section 2.4.1.

 

1.68.       “Representatives”
means (a) with respect to Licensee, Licensee, its Affiliates, its Sublicensees and each of their respective officers, directors,
employees, consultants, contractors and agents and (b) with respect to OSI, OSI, its Affiliates and each of their respective officers,
directors, employees, consultants, contractors and agents.

 

1.69.       “Royalty
Payments” has the meaning set forth in Section 3.3.1.

 

1.70.       “Royalty
Term” means, on a country-by-country basis with respect to any particular Licensed Product in any particular country
in the Territory, the period beginning upon the date of the First Commercial Sale of such Licensed Product in such country and
ending on the later to occur of (a) the expiry of the last Valid Claim of an OSI Product Patent Covering such Licensed Product
in such country, (b) expiration of regulatory exclusivity in such country, and (c) ten (10) years from the First Commercial Sale
of such Licensed Product in such country.

 

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1.71.       “Senior
Officers” has the meaning set forth in Section 10.1.

 

1.72.       “Sublicense
Income” means consideration received by Licensee or an Affiliate from a Sublicensee or such Sublicensee’s
Affiliates (including upfront payments, sublicense maintenance fees, milestone payments, option fees and other sublicense revenue)
that is not a royalty based upon Net Sales of a Licensed Product. “Sublicense Income” excludes (a) payments received
from Sublicensees that are (i) made to fund the costs of the bona fide research or development of Licensed Products on or
after the effective date of the sublicense, or (ii) proceeds from equity investments by a Third Party to the extent at fair market
value and unrelated to the Licensed Products, and (b) any purchase price payments received by Licensee in connection with a Change
of Control of Licensee.

 

1.73.       “Sublicensee”
means any Person to whom Licensee grants or has granted, directly or indirectly (e.g. a sublicensee of a sublicensee of Licensee),
a permitted sublicense of rights licensed by OSI to Licensee under this Agreement.

 

1.74.       “Term”
has the meaning set forth in Section 8.1.

 

1.75.       “Territory”
means worldwide.

 

1.76.       “Third
Party” means any Person other than Licensee, OSI or their respective Affiliates.

 

1.77.       “Valid
Claim” means a claim of an issued and unexpired patent within the OSI Product Patents covering the composition,
manufacture, use, method of use, sale, offer for sale or import of a Licensed Product, which patent is owned or Controlled by OSI
and has not (a) expired or been canceled, (b) been declared invalid by an unreversed and unappealable decision of a court or other
appropriate body of competent jurisdiction, (c) been admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise
or (d) been abandoned.

 

1.78.       “Withholding
Tax” has the meaning set forth in Section 3.5.2.

 

		2.	LICENSE GRANTS AND TECHNOLOGY TRANSFER

 

2.1.       Exclusive
License to Licensee. Subject to the terms and conditions of this Agreement, OSI hereby grants to Licensee an exclusive, worldwide,
royalty-bearing, sublicensable (subject to the provisions of Section 2.2) license during the Term under OSI’s right,
title and interest in and to the OSI Product Patents and OSI Product Know-How, to Develop, have Developed, Manufacture, have Manufactured,
Commercialize and have Commercialized Licensed Products in the Field in the Territory.

 

2.2.       Licensee
Sublicensees. Licensee may grant sublicenses of the rights granted under Section 2.1 to any of its Affiliates
and Third Parties, provided that:

 

2.2.1.       no
such sublicense shall diminish Licensee’s duties or obligations under the Agreement, and Licensee shall remain liable and
responsible for such duties and obligations;

 

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2.2.2.       any
act or omission of a Sublicensee which would be a breach of this Agreement if performed by Licensee shall be deemed a breach by
Licensee of this Agreement;

 

2.2.3.       promptly
following OSI’s request, Licensee shall provide OSI with a fully executed copy of any sublicense agreement and any amendments
or other modifications thereto (which Licensee may redact as reasonably necessary to protect confidential or highly sensitive information)
promptly upon execution of such sublicense, amendment, or other modification (as applicable);

 

2.2.4.       each
sublicense shall be consistent with the terms of this Agreement (including confidentiality, non-disclosure, and non-use provisions
at least as restrictive or protective of the Parties as those set forth in this Agreement) and each Sublicensee shall undertake,
in the applicable sublicense, to perform its obligations under the sublicense in a manner consistent with, and to the extent applicable
to, the terms of this Agreement; and

 

2.2.5.       each
sublicense shall terminate automatically effective as of the earlier of (a) termination of this Agreement or (b) the termination
of the applicable sublicense agreement.

 

2.3.       No
Implied Rights. Except as expressly provided in this Agreement, neither Party will be deemed to have granted the other
Party (by implication, estoppel or otherwise) any right, title, license or other interest in or with respect to any Patents, Know-How
or other intellectual property rights or information owned or controlled by such Party.

 

2.4.       Assignment;
Data Transfer; Third Party Contractors.

 

2.4.1.       Regulatory
Documentation. 

 

(a)       Upon
the terms and subject to the conditions of this Agreement, OSI shall use reasonable efforts to, within thirty (30) days following
the Effective Date, transfer, convey and deliver to Licensee, all of OSI’s right, title, interest and obligations in or under
all Regulatory Documentation that are set forth on Schedule 5 to the extent exclusively related to Licensed Products (any
such transfer, conveyance and delivery, in whole or in part, a “Regulatory Transfer”).

 

(b)       Immediately
upon a Regulatory Transfer, Licensee shall hereby acquire and accept from OSI all right, title and interest to, and agree to perform
and discharge all obligations under, the Regulatory Documentation subject to such Regulatory Transfer. Following the last Regulatory
Transfer, OSI will submit to the FDA a letter to transfer the inactivated IND application for the Compound (the “Existing
IND”) to Licensee, and Licensee shall, within 24 hours following such submission by OSI to the FDA, submit its own letter
to the FDA confirming (a) that Licensee has received such Regulatory Documentation in connection with the Regulatory Transfer,
(b) that Licensee hereby acquires and accepts from OSI all right, title and interest to, and agree to perform and discharge all
obligations under, the Regulatory Documentation, and (c) the contact information for Licensee with respect to such inactivated
IND application, in each case ((a) through (c)), in accordance with this Section 2.4.1. Licensee shall reasonably cooperate
with OSI in performing the obligations set forth above in this Section 2.4.1 and, notwithstanding anything to the contrary
in this Agreement, OSI shall be relieved from any obligation under this Section 2.4.1 to the extent Licensee has not provided
such reasonable cooperation.

 

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2.4.2.       Data
Transfer. 

 

(a)       OSI
will use reasonable efforts to provide to Licensee copies of information included in the OSI Product Know-How and set forth on
Schedule 1 if and to the extent such OSI Product Know-How is requested by Licensee within the thirty (30) days following
the Effective Date and solely to the extent such OSI Product Know-How is in OSI’s possession as of the Effective Date; provided,
however, that such copies will not include (a) any documents protected by attorney-client privilege or that constitute attorney
work-product; or (b) any financial, accounting or tax records of OSI or its Affiliates. Without limiting any of the foregoing,
OSI shall have no obligation to provide any copies of OSI Product Know-How to Licensee under this Section 2.4.2 after such
30-day period following the Effective Date. OSI may make OSI Product Know-How delivered to Licensee under this Section 2.4.2
available in such reasonable form as OSI determines, including, if OSI so elects, in the form such OSI Product Know-How is maintained
by OSI.

 

(b)       In
addition to the data transfer contemplated above, for a period of one (1) year following the Effective Date, OSI shall, at no cost
to Licensee, provide reasonable support to Licensee to allow Licensee to answer questions posed by the FDA or other competent regulatory
authorities regarding the Existing IND to the extent that OSI has the relevant historical information; provided, however, that
such support shall not obligate OSI to (i) attend any in-person meetings with Licensee, the FDA or other Regulatory Authorities
or (ii) incur any material out of pocket costs or expenses.

 

2.4.3.       Third
Party Contractors. Upon Licensee’s reasonable request, OSI will use reasonable efforts to (a) identify any tangible embodiments
of data, reports and information to the extent such exclusively relates to the Compound and are held by Third Party contractors
or their Affiliates, and (b) to the extent permitted under Applicable Law and OSI’s contractual obligations with respect
to such Third Party contractors, execute and deliver one or more written instruments as may be reasonably requested by Licensee
to enable Licensee to communicate with such Third Party contractors in order to access such tangible embodiments. Any such data,
reports and information received by Licensee (i) will be deemed OSI’s Confidential Information under this Agreement, (ii)
to the extent Controlled by OSI or any of its Affiliates, will be deemed OSI Product Know-How under this Agreement and (iii) will
solely be used by Licensee for the Development, Manufacturing, Commercialization and other exploitation of Licensed Products in
the Field in the Territory. Notwithstanding any provision of this Agreement to the contrary, OSI will not have any obligation to
incur any payment or other obligation or to incur any out of pocket expenses in connection with the performance of its obligations
under this Section 2.4.3.

 

    	 	11	 

     

    

  

2.4.4.       No
Other Obligations. Except as expressly set forth in this Section 2.4, OSI shall have no other obligation with respect
to any other technology transfer, Manufacture or Manufacturing scale-up, and Licensee shall be solely responsible for all activities
associated therewith and all costs and expenses related thereto.

 

		3.	PAYMENTS.

 

3.1.       Upfront
Payment. Within five (5) Business Days following the Effective Date, Licensee will pay to OSI by wire transfer of immediately
available funds a payment of (***) Dollars (***$***).

 

3.2.       Milestone
Payments. No later than thirty (30) days after the earliest achievement by Licensee, its Affiliates or Sublicensees
of each milestone event set forth below for the first Licensed Product to achieve such event, Licensee will pay to OSI the corresponding
milestone payment set forth in Table 3.2 below (the milestone events set forth in Table 3.2, the “Milestone
Events” and the milestone payments set forth in Table 3.2, the “Milestone Payments”).

 

	
         Table 3.2 –
Milestone Payments

	 	Milestone Event	Milestone 

Payment
	(a)	 (***)	(***$***)
	(b)	 (***)1	(***$***)
	(c)	 (***)	(***$***)
	(d)	 (***)	(***$***)

 

3.3.       Royalty
Payments.

 

3.3.1.       Royalties.
Subject to the provisions of Section 3.3.2, Licensee will make royalty payments to OSI for all Licensed Products sold by
or on behalf of Licensee, its Affiliates or Sublicensees in the Territory during a Calendar Year, calculated by multiplying the
applicable royalty rate set forth below in Table 3.3.1 by the applicable increment of aggregate Net Sales of Licensed Products
sold in the Territory during such Calendar Year (the royalty payments due with respect to Net Sales of Licensed Products pursuant
to this Section 3.3.1, the “Royalty Payments”).

 

	
         Table 3.3.1 –
Royalty Payments

	Increment of Aggregate Calendar 

Year Net Sales of a Product	Applicable Royalty Rate
	Less than (***$***)	(***%***)
	Greater than or equal to (***$***)but less than (***$***)	(***%***)
	Greater than or equal to (***$***)	(***%***)

 

 

1 The
Parties acknowledge and agree that Licensee initially intends to study the Compound to achieve proof of concept in a signal finding
clinical study or Phase 1b/2a study (***).

 

    	 	12	 

     

    

 

3.3.2.       Royalty
Payments. Royalty payments will be payable on a Calendar Year basis as further set forth in Section 3.5.1.

 

3.4.       Sublicense
Income. In addition to and without limiting any obligation to pay Milestone Payments or Royalty Payments under this
Agreement, all Sublicense Income received by Licensee or any of its Affiliates will be deemed to be Net Sales of Licensee and Licensee
will pay royalty payments to OSI on such deemed Net Sales pursuant to Section 3.3.1. In the event that Licensee or any of
its Affiliates receives non-cash consideration in connection with a sublicense, Sublicense Income shall be calculated based on
the fair market value of such consideration at the time of the transaction, assuming an arm’s length transaction made in
the ordinary course of business. Any Sublicense Income that is paid to OSI and is derived from the achievement by Sublicensee of
a milestone event under such sublicense that is the same as a Milestone Event under this Agreement shall be creditable towards
the applicable Milestone Payment owed by Licensee to OSI with respect to such Milestone Event, solely to the extent such Milestone
Payment has not been otherwise paid by Licensee to OSI.

 

3.5.       Reports
and Payments.

 

3.5.1.       Royalty
Statements and Payments. Commencing with the Calendar Quarter during which the First Commercial Sale of a Licensed Product
is made anywhere in the Territory, within thirty (30) days following the end of each Calendar Quarter, Licensee will deliver to
OSI a report setting forth, for such Calendar Quarter, the following information: (a) the amount of gross sales and Net Sales of
each Licensed Product sold by Licensee and its Affiliates and Sublicensees in each country and a schedule describing, in reasonable
detail, the gross-to-net deductions used to determine such Net Sales of each such Licensed Products for such Calendar Quarter;
(b) a calculation of the Royalty Payment due on such Net Sales of each Licensed Product in each country; (c) the exchange rate
used for converting any Net Sales recorded in a currency other than Dollars; (d) any withholding taxes required to be made from
such Royalty Payments; and (e) the quantity and description of each Licensed Product sold by Licensee or its Affiliate or Sublicensees
in each country during such Calendar Quarter comprising such Net Sales. Notwithstanding the reporting obligation set forth above,
Royalty Payments shall only be due and shall be paid within thirty (30) days of the end of the applicable Calendar Year. All Royalty
Payments shall be paid in United States dollars.

 

    	 	13	 

     

    

  

3.5.2.       Taxes
and Withholding. Each Party shall be responsible for its own taxes, duties, levies, imposts, assessments, deductions, fees,
withholdings or similar charges imposed on or measured by net income or overall gross income (including branch profits), gross
receipts, capital, ability or right to do business, property, and franchise or similar taxes pursuant to applicable Law. If Licensee
is required to deduct or withhold from any payment due hereunder any taxes, duties, levies, imposts, assessments, deductions, fees,
and other similar charges by Applicable Law or any Governmental Authority (“Withholding Taxes”), then Licensee
shall pay such Withholding Taxes to the local applicable Governmental Authority and make the payment to OSI of the net amount due
after deduction or withholding of such taxes. Such Withholding Taxes shall be treated for all purposes of this Agreement as having
been paid to OSI hereunder. Licensee shall submit reasonable proof of payment of the Withholding Taxes within a reasonable period
of time after such Withholding Taxes are remitted to the Governmental Authority. The Parties shall reasonably cooperate to eliminate
or minimize any such Withholding Taxes. Licensee shall hold OSI harmless for any fees, penalties and interest that are imposed
on OSI arising out of Licensee’s failure to withhold and remit Withholding Taxes to Governmental Authorities in accordance
with this Section and Applicable Laws. The Parties will reasonably cooperate to provide sufficient documentation to enable OSI
to receive any credits available under Applicable Law.

 

3.5.3.       No
Refunds. Except as expressly provided herein, all payments by Licensee to OSI under this Agreement will be irrevocable, non-refundable,
and non-creditable.

 

3.5.4.       Currency;
Exchange Rate. All payments to be made by Licensee to OSI under this Agreement will be made in Dollars by electronic funds
transfer in immediately available funds to a bank account designated in writing by OSI. Conversion of Net Sales recorded in local
currencies will be converted to Dollars at the average of the applicable exchange rate set forth in The Wall Street Journal
or any successor thereto (or if the Wall Street Journal or its successor no longer publishes such rate, as reported in another
source mutually agreed by the Parties) over the applicable Calendar Year.

 

3.5.5.       Late
Payments. Any payments or portions thereof due hereunder that are not paid on the date such payments are due under this Agreement
will bear interest at a rate equal to the lesser of: (a) three (3) percentage points above the prime rate as published by The
Wall Street Journal or any successor thereto (or if the Wall Street Journal or its successor no longer quotes such rate,
as reported in another source mutually agreed by the Parties) on the first day of each Calendar Quarter in which such payments
are overdue; or (b) the maximum rate permitted by Applicable Law; in each case, calculated on the number of days such payment is
delinquent, compounded monthly. Payment of such interest by Licensee shall not limit, in any way, OSI’s right to exercise
any other remedies OSI may have as a consequence of any payment due but unpaid hereunder.

 

3.5.6.       Financial
Records and Audits.

 

(a)       Licensee
will maintain, and will cause its Affiliates and Sublicensees to maintain, complete and accurate records in sufficient detail to
permit OSI to confirm the accuracy of the amount of Royalty Payments and other amounts payable under this Agreement. Licensee will
maintain, and will cause its Affiliates and its Sublicensees to maintain, such records for the longer of (a) at least three (3)
years after the end of the Calendar Year in which they were generated or otherwise relevant and (b) as is required by Applicable
Law.

 

    	 	14	 

     

    

  

(b)       Licensee
will permit an independent certified public accounting firm of nationally recognized standing (such firm to be mutually agreed
upon by the Parties in good faith), to examine, at OSI’s sole expense and upon reasonable prior notice, the relevant books
and records of Licensee, its Affiliates and its Sublicensees as may be reasonably necessary to verify the amounts reported by Licensee
in accordance with Section 3.5.1 and all other amounts payable under this Agreement. An examination by OSI under this Section
3.5.6(b) will be subject to standard confidentiality obligations, will occur not more than once in any Calendar Year, not more
than once as to any Calendar Year or Calendar Quarter, and will be limited to the pertinent books and records for any Calendar
Year ending not more than three (3) years before the date of the request, except with respect to “for cause”
examinations due to OSI’s reasonable good faith belief that the payments made to OSI by Licensee in such Calendar Year have
not been made in accordance with the terms of this Agreement or a finding of an underpayment to OSI in the past twelve (12) months,
in which case more frequent or a repeat examinations by OSI will be permitted. The accounting firm will be provided access to such
books and records at Licensee’s, its Affiliates’ or its Sublicensees’ facility(ies) where such books and records
are normally kept and such examination will be conducted during Licensee’s normal business hours. Upon completion of the
audit, the accounting firm will provide both Licensee and OSI a written report disclosing any discrepancies in (i) the reports
submitted by Licensee or (ii) any amounts paid by Licensee under this Agreement, and, in each case, the specific details concerning
any discrepancies.

 

(c)       If
such accounting firm concludes that additional amounts were due to OSI, then Licensee will pay to OSI such additional amounts within
thirty (30) days of the date Licensee receives such accountant’s written report. Further, if the amount of such underpayments
exceeds more than five percent (5%) of the amounts that were properly payable to OSI, then Licensee will reimburse OSI for OSI’s
out-of-pocket costs in connection with the audit. If such accounting firm concludes that Licensee made payments to OSI under this
Agreement in excess of the amounts due under this Agreement, then OSI will refund such overpayments to Licensee, within thirty
(30) days of the date OSI receives such accountant’s report.

 

3.6.       No
Deductions or Offsets. Except as otherwise expressly set forth herein, there shall be no deduction or offset
from, nor shall Licensee have any right to hold back any payments owed to OSI under or in connection with this Agreement for any
reason (whether or not there is a dispute regarding payment or other rights or obligations under this Agreement).

 

		4.	DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION.

 

4.1.       Development.

 

4.1.1.       General
Responsibilities. Licensee will have sole responsibility for the Development of Licensed Products in the Field in the Territory,
and will bear all costs associated with such activities.

 

    	 	15	 

     

    

  

4.1.2.       Development
Plan. Licensee will use Commercially Reasonable Efforts to complete all activities and satisfy all objectives as set forth
in the Development Plan in accordance with the timeline set forth therein. Licensee may only amend the Development Plan in a manner
consistent with Licensee’s diligence obligations in Section 4.1.3 (the “Diligence Obligations”)
and upon written notice to OSI.

 

4.1.3.       Development
of Licensed Products. 

 

(a)       The
Parties acknowledge that as part of the Development Plan, Licensee will conduct one or more “signal finding studies”
of the Compound in one or more indications. Licensee shall keep OSI reasonably informed of the progress of each such study. For
the avoidance of doubt, the Parties acknowledge and agree that Licensee initially intends to study the Compound to achieve proof
of concept in a signal finding clinical study or Phase 1b/2a study (the “Initial Signal Finding Study”) and
that dosing in the Initial Signal Finding Study shall not constitute achievement of the milestone set forth in Section 3.2(b).

 

(b)       Licensee
will use Commercially Reasonable Efforts to Develop (and Manufacture for Development) and seek Regulatory Approval for Licensed
Products in the Field in the Territory.

 

4.1.4.       Development
Reports. On a Licensed Product-by-Licensed Product basis, within ten (10) Business Days of each anniversary of the Effective
Date until the First Commercial Sale of such Licensed Product in both the United States and the European Union, Licensee shall
provide OSI a detailed written report describing the Development activities performed, or caused to be performed, since the preceding
report, the Development activities in process, and the planned future Development activities expected to be initiated prior to
the next anniversary of the Effective Date, in each case by or on behalf of Licensee, its Affiliates and Sublicensees with respect
to such Licensed Product in the Field in the Territory.

 

4.2.       Regulatory
Matters.

 

4.2.1.       Regulatory
Reporting. Licensee or its Representatives will be responsible for making and filing all filings, reports and communications
with all Regulatory Authorities with respect to any Licensed Product in the Field in the Territory, including all reports required
to be filed in order to obtain or maintain any Regulatory Approvals granted for Licensed Products in the Field in the Territory.

 

4.2.2.       Regulatory
Approvals. Licensee or its Representatives will be responsible for preparing and filing applications, in its own name, for
Regulatory Approval for Licensed Products in the Field in the Territory, including communicating with any Regulatory Authority
both prior to and following Regulatory Approval.

  

    	 	16	 

     

    

 

4.2.3.       Pharmacovigilance
and Safety. A transfer of the global safety database from OSI to Licensee will
be completed within one hundred and twenty (120) calendar days following the Effective Date. Other than with respect to such transfer
of the global safety database (to the extent required), OSI shall have no ongoing pharmacovigilance obligations with respect to
the Compound and Licensed Products. Licensee shall assume all pharmacovigilance activities and obligations for the Compound and
Licensed Products immediately following the Effective Date.

 

4.3.       Manufacturing.

 

4.3.1.       Licensee
will have sole responsibility for all Manufacturing activities and associated costs and expenses for the Manufacture of the Compound
and all Licensed Products.

 

4.3.2.       Notwithstanding
Licensee’s obligation for all Manufacturing activities and associated costs and expenses to as set forth above, OSI shall,
within thirty days (30) of Licensee notifying OSI of the carrier it has selected and providing all necessary relevant shipping
information, deliver to Licensee 250g of non-clinical drug substance (the “Drug Material”) FCA (Incoterms 2010)
OSI’s place of shipment. Upon such delivery, all right, title, interest and risk of loss in and to such quantity of Drug
Material will vest in Licensee.

 

4.4.       Commercialization.

 

4.4.1.       General
Responsibilities. Licensee will have sole responsibility for the Commercialization of Licensed Products in the Field in the
Territory, and will bear all costs associated with such activities.

 

4.4.2.       Commercialization
of Licensed Products. Following receipt of Regulatory Approval for a Licensed Product in a given country in the Territory,
Licensee will use Commercially Reasonable Efforts to Commercialize (and Manufacture for Commercialization) such Licensed Product
in such country.

 

4.4.3.       Commercialization
Reports. On a Licensed Product-by-Licensed Product basis, following the First Commercial Sale of a Licensed Product in the
Territory, within the first Calendar Quarter of each Calendar Year thereafter, Licensee shall provide to OSI a detailed report
describing the Commercialization activities performed with respect to such Licensed Product, or caused to be performed, during
the prior Calendar Year, the Commercialization activities in process, and the planned future Commercialization activities expected
to be initiated during the then-current Calendar Year, in each case by or on behalf of Licensee, its Affiliates and Sublicensees
with respect to such Licensed Product in the Field in the Territory.

 

4.4.4.       Trademark.
Licensee and its Representatives shall have the sole right to select and own all trademarks associated with the Commercialization
of the Licensed Product in the Territory. Notwithstanding any provision in this Agreement to the contrary, Licensee will not use
any trademarks Controlled by OSI or any of its Affiliates (including OSI’s or its Affiliates’ corporate name) or register
or seek to register any trademark that is substantially the same as or deceptively or confusingly similar thereto without OSI’s
prior written consent.

 

    	 	17	 

     

    

  

		5.	INTELLECTUAL PROPERTY.

 

5.1.       Inventorship.
All determinations of inventorship under this Agreement will be made in accordance with U.S. patent law.

 

5.2.       Prosecution
and Enforcement of Patents.

 

5.2.1.       Prosecution.
Licensee shall have the right to prosecute and maintain the OSI Product Patents in the Territory in OSI’s name at Licensee’s
expense. In order to give effect to the foregoing, OSI shall grant and not revoke or terminate a customary power of attorney to
Licensee’s patent counsel during the Term to allow such counsel to interact directly with the United States Patent and Trademark
Office in respect of the OSI Product Patents. Licensee shall keep OSI reasonably informed as to all patent prosecution and maintenance
activities concerning the OSI Product Patents in the Territory and shall consult with OSI regarding the same. OSI shall be allowed
to review all documents prepared in connection with such prosecution and maintenance matters and shall have the right to provide
comments to Licensee. Licensee shall consider all such OSI comments in good faith and shall reasonably reflect such OSI comments
in the applicable documents. Notwithstanding anything to the contrary in this Section 5.2.1, Licensee shall not allow any
OSI Product Patent to lapse in the Territory without OSI’s express written permission. Should Licensee decide to abandon
any OSI Product Patent, and OSI does not provide written permission, such patent shall become a “Licensee Abandoned Patent”.
OSI shall have the right to prosecute and maintain any Licensee Abandoned Patent, and such Licensee Abandoned Patent shall no longer
be considered an OSI Product Patent. For the avoidance of doubt, Licensee shall have no rights in any Licensee Abandoned Patent,
even if required to enjoy the benefits of this Agreement.

 

5.2.2.       Enforcement.
Each Party will promptly notify the other Party in the event of any actual, potential or suspected infringement of the OSI Product
Patents by any Third Party (such infringement, an “Infringement”), including any Infringement that arises as
a result of the manufacture, sale, use or importation of a product that is competitive with a Licensed Product in the Territory
(a “Competing Infringement”). Licensee shall have the first right to prosecute any Competing Infringement of
the OSI Product Patents in the Territory at its sole expense and, subject to this Section 5.2.2, Licensee shall retain control
of the prosecution of such claim, suit or proceeding; provided that Licensee shall not, without the prior written consent
of OSI, enter into any compromise or settlement relating to such litigation without OSI’s prior written consent. Licensee
shall keep OSI updated as to the steps it intends to take to prosecute a Competing Infringement and shall otherwise provide OSI
with any information reasonably requested by OSI. OSI shall have the right to join as a party to such claim, suit or proceeding
in the Territory and participate with its own counsel at its own expense; provided that Licensee shall retain control of
the defense in such claim, suit, or proceeding. If Licensee does not take commercially reasonable steps to prosecute a Competing
Infringement (a) within ninety (90) days following the first notice provided above with respect to the Competing Infringement,
or (b) ten (10) Business Days before the time limit, if any, set forth in Applicable Law for filing of such actions, whichever
comes first, then OSI may then prosecute the Competing Infringement of an OSI Product Patent in the Territory at its own expense
and OSI shall retain control of such prosecution; provided that that OSI shall not, without the prior written consent of
Licensee, enter into any compromise or settlement relating to such litigation without Licensee’s prior written consent. For
clarity, OSI shall have the exclusive right to enforce OSI Product Patents for any Infringement that is not a Competing Infringement
and Licensee shall reasonably cooperate with OSI in any such action.

 

    	 	18	 

     

    

  

5.2.3.       Cooperation.
The Parties agree to cooperate fully in any Competing Infringement action pursuant to this Section 5.2, including by providing
reasonably requested records that may assist the enforcing Party with such Competing Infringement claim. If the Party having the
right to initiate a Competing Infringement action under Section 5.2.2 brings such an action (the “Initiating Party”),
then the non-Initiating Party shall, if necessary, either (at the Initiating Party’s discretion) furnish a power of attorney
solely for such purpose, join in, or be named as a necessary party to, such action, any such action to be taken at the Initiating
Party’s expense. The Initiating Party shall provide the non-Initiating Party with copies of all pleadings and other documents
filed with the court and shall consider reasonable input from the non-Initiating Party during the course of the proceedings.

 

5.2.4.       Recoveries.
Any recoveries resulting from an enforcement action to the extent allocable to a claim of Competing Infringement of an OSI Product
Patent in the Field in the Territory shall first be applied to reimburse each Party’s costs and expenses in connection therewith.
Any such recoveries in excess of such costs and expenses shall be allocated as follows: (a) if Licensee is the Initiating Party,
such excess recoveries shall be (***) in the Calendar Year in which Licensee actually collects such excess recoveries; and (b)
if OSI is the Initiating Party, (***) percent (***%***) of such excess recoveries to OSI and (***) percent (***%***) of such excess
recoveries to Licensee.

 

5.3.       Defense
Actions.

 

5.3.1.       General.
Each Party shall promptly notify the other Party in writing of any Defense Action of which it becomes aware. Licensee shall
have the first right to control the defense of any Defense Action, and to compromise, litigate, settle or otherwise dispose of
any such Defense Action, provided that (a) Licensee will keep OSI timely informed of the proceedings and filings, and provide
OSI with copies of all material communications pertaining to each Defense Action, and (b) Licensee shall not compromise, litigate,
settle or otherwise dispose of any such Defense Action without OSI’s prior written consent. OSI may participate in any such
claim, suit, or proceeding in the Territory with counsel of its choice at its own expense; provided that Licensee shall
retain control of the defense in such claim, suit, or proceeding. If Licensee elects not to defend or control the defense of any
OSI Product Patents in a Defense Action brought in the Territory, or otherwise fails to initiate and maintain the defense of any
such claim, suit, or proceeding, then OSI may conduct and control the defense of any such claim, suit, or proceeding of the OSI
Product Patents at its own expense.

 

    	 	19	 

     

    

  

5.3.2.       Each
Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection
with its activities set forth in this Section 5.3, including by being joined as a party plaintiff in such action or proceeding,
providing access to relevant documents and other evidence, and making its employees available at reasonable business hours. In
connection with any Defense Action, the Party controlling such Defense Action shall consider in good faith any comments from the
other Party and shall keep the other Party reasonably informed of any steps taken, and shall provide copies of all documents filed,
in connection with such Defense Action. In connection with the activities set forth in this Section 5.3, the controlling
Party shall consult with the other Party as to the strategy for the defense of the OSI Product Patents.

 

		6.	CONFIDENTIALITY.

 

6.1.       Confidentiality.
Except to the extent expressly authorized by this Agreement, the Parties agree that, during the Term and for five (5) years following
the end of the Term, each Party (the “Receiving Party”) receiving any Confidential Information of the other
Party (the “Disclosing Party”) hereunder will: (a) keep the Disclosing Party’s Confidential Information
confidential; (b) not disclose, or permit the disclosure of, the Disclosing Party’s Confidential Information; and (c) not
use, or permit to be used, the Disclosing Party’s Confidential Information for any purpose other than as expressly permitted
under the terms of this Agreement.

 

6.2.       Authorized
Disclosure. Notwithstanding the foregoing provisions of Section 6.1, each Party may disclose Confidential
Information belonging to the other Party to the extent such disclosure is necessary:

 

6.2.1.       to
Governmental Authorities (a) to obtain or maintain INDs or Regulatory Approvals for any Licensed Product within the Territory,
and (b) in order to respond to inquiries, requests or investigations relating to Licensed Products or this Agreement;

 

6.2.2.       in
connection with litigation directly related to a Licensed Product in the Field;

 

6.2.3.       responding
to an order of a court of competent jurisdiction or other Governmental Authority; provided that the Receiving Party will
first have given to the Disclosing Party notice and a reasonable opportunity to quash the order or obtain a protective order requiring
that the Confidential Information be held in confidence or used only for the purpose for which the order was issued; and provided
further that if such order is not quashed or a protective order is not obtained, the Confidential Information disclosed will
be limited to the information that is legally required to be disclosed;

 

6.2.4.       Licensee
may, on a need-to-know basis, disclose Confidential Information belonging to OSI (including the terms of the Agreement) to any
Sublicensee who has agreed in writing to non-disclosure and non-use provisions with respect to such Confidential Information that
are at least as restrictive as those set forth in this Article 6;

 

6.2.5.       to
comply with Applicable Law (including regulations promulgated by securities exchanges);

 

    	 	20	 

     

    

  

6.2.6.       disclosure
to its Affiliates, Sublicensees and Third Parties of a redacted copy of this Agreement, only on a need-to-know basis and solely
in connection with the performance by the Disclosing Party of its obligations or the exercise of its rights under this Agreement
(including with respect to Development, Manufacturing and Commercialization of Licensed Products), provided that each disclosee,
prior to any such disclosure, must be bound by obligations of confidentiality and non-use at least as protective as those set forth
in this Article 6; and

 

6.2.7.       in
the case of the terms of this Agreement (including a complete non-redacted copy), disclosure to the current or prospective lenders
to, acquirors of, investors in or strategic partners with such Party; provided that provided that each disclosee, prior
to any such disclosure, must be bound by obligations of confidentiality and non-use at least as protective as those set forth in
this Article 6.

 

6.3.       SEC
Filings and Other Disclosures. Either Party may disclose the terms of this Agreement and make any other public written
disclosure regarding the existence of, or performance under, this Agreement, to the extent required, in the reasonable opinion
of such Party’s legal counsel, to comply with (a) Applicable Law, including the rules and regulations promulgated by the
United States Securities and Exchange Commission or (b) any equivalent Governmental Authority, securities exchange or securities
regulator in any country in the Territory. Before disclosing this Agreement or any of the terms hereof pursuant to this Section
6.3, the Parties will consult with one another on the terms of this Agreement to be redacted in making any such disclosure,
with the Disclosing Party providing as much advance notice as is feasible under the circumstances, and giving consideration to
the comments of the other Party. Further, if a Party discloses this Agreement or any of the terms hereof in accordance with this
Section 6.3, such Party will, at its own expense, seek such confidential treatment of confidential portions of this Agreement
and such other terms, as may be reasonably requested by the other Party and limit its disclosure of such Confidential Information
to only that required to comply with applicable Law.

 

6.4.       Public
Announcements; Publications.

 

6.4.1.       Announcements.
Except with respect to the press release attached hereto as Schedule 6 and except as set forth in Section 6.3, neither
Party will make any press release or other public announcement regarding this Agreement without the prior written approval of the
other Party.

 

6.4.2.       Publications.
During the Term and subject to the terms of this Agreement, Licensee may make publications, presentations or public announcements
concerning its Development, Manufacture or Commercialization activities with respect to any Licensed Product in the Field. In no
event shall Licensee disclose any of OSI’s Confidential Information in any such publication or announcement without obtaining
OSI’s prior written consent to do so.

 

		7.	REPRESENTATIONS AND WARRANTIES.

 

7.1.       Mutual
Representations and Warranties. Each of OSI and Licensee hereby represents and warrants to the other Party that:

 

7.1.1.       it
is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization;

 

    	 	21	 

     

    

  

7.1.2.       the
execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite action under the
provisions of its charter, bylaws, LLC agreement and other organizational documents, and does not require any action or approval
by any of its shareholders, members or other holders of its voting securities or voting interests;

 

7.1.3.       it
has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder

 

7.1.4.       this
Agreement has been duly executed and is a legal, valid and binding obligation on such Party, enforceable against such Party in
accordance with its terms; and

 

7.1.5.       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 or default under any contractual or other obligation of such Party existing
as of the Effective Date.

 

7.2.       Representations
and Warranties of OSI. OSI hereby represents and warrants to Licensee that:

 

7.2.1.       OSI
has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the OSI Product Patents
in a manner that conflicts with any rights granted to Licensee under this Agreement, and OSI is under no obligation to make any
such transfers, conveyances or encumbrances;

 

7.2.2.       To
OSI’s Knowledge, no Third Party is infringing or misappropriating the OSI Product IP in the Field in the Territory; 

 

7.2.3.       OSI
has not received written notice, and to OSI’s Knowledge, no Third Party has alleged that: (a) the licenses granted under
the OSI Product IP to Licensee under this Agreement or the exploitation of the OSI Product IP violates, infringes, misappropriates
or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party or (b) any Third Party
has any right, title, or interest in, to, and under any OSI Product IP; and

 

7.2.4.       To
OSI’s Knowledge: there are no claims, judgments or settlements against or owed by OSI or pending or threatened claims or
litigation relating to the OSI Product IP.

 

7.3.       Mutual
Covenants. Each of OSI and Licensee hereby covenants to the other Party that, during the Term:

 

7.3.1.       it
will perform its obligations under this Agreement in compliance with Applicable Laws;

 

    	 	22	 

     

    

  

7.3.2.       it
will not be debarred or disqualified under the U.S. Federal Food, Drug and Cosmetic Act or comparable laws in any country or jurisdiction
other than the U.S. and, to its knowledge, does not, and will not during the Term knowingly, employ or use, directly or indirectly,
including through Affiliates or, in the case of Licensee, Sublicensees, the services of any person who is debarred or disqualified,
in connection with activities relating to any Compound or Licensed Product. In the event that either Party becomes aware of the
debarment or disqualification or threatened debarment or disqualification of any person providing services to such Party, directly
or indirectly, including through Affiliates or, in the case of Licensee, Sublicensees, which directly or indirectly relate to activities
contemplated by this Agreement, such Party shall promptly notify the other Party in writing and such Party shall cease employing,
contracting with, or retaining any such person to perform any such services; and

 

7.3.3.       such
Party and, to its knowledge, its and its Affiliates’ or, in the case of Licensee, its Sublicensees’ employees and contractors,
shall not, in connection with the performance of their respective obligations under this Agreement, directly or indirectly through
Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize
the giving of anything of value to a public official or entity or other person for purpose of obtaining or retaining business for
or with, or directing business to, any Person, including either Party (it being understood that, without any limitation to the
foregoing, such Party, and to its knowledge, its and its Affiliates’ or, in the case of Licensee, its Sublicensees’
employees and contractors, has not directly or indirectly promised, offered or provided any corrupt payment, gratuity, emolument,
bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or any other Person in
connection with the performance of such Party’s obligations under this Agreement, and shall not, directly or indirectly,
engage in any of the foregoing).

 

7.4.       Disclaimer.
EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTION 7.2, THE OSI PRODUCT IP AND DRUG MATERIAL PROVIDED BY OSI HEREUNDER ARE
PROVIDED “AS IS” AND, EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN SECTION 7.2, OSI MAKES NO REPRESENTATIONS
AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO ANY PATENTS OR KNOW-HOW, OSI PRODUCT IP, COMPOUNDS,
LICENSED PRODUCTS OR INVENTIONS HEREUNDER, INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY OF ANY PATENTS, TITLE, QUALITY, MERCHANTABILITY,
FITNESS FOR A PARTICULAR USE OR PURPOSE, PERFORMANCE, AND NONINFRINGEMENT OF ANY THIRD PARTY PATENTS OR OTHER INTELLECTUAL PROPERTY
RIGHTS.

 

		8.	TERM AND TERMINATION.

 

8.1.       Term.
The term of this Agreement will commence on the Effective Date and shall continue, on a country-by-country and Licensed Product-by-Licensed
Product basis (in the Territory), unless this Agreement is terminated earlier in accordance with this Article 8, (the “Term”).
Upon expiration of the Royalty Term for a given Licensed Product in a given country in the Territory, the license granted from
OSI to Licensee under Section 2.1 with respect to such Licensed Product in such country shall become a fully paid-up, royalty-free
license within such country; provided that (a) this Agreement has not otherwise been terminated prior to expiration of such
Royalty Term and (b) Licensee has paid to OSI all Royalty Payments that have accrued with respect to such Licensed Product in such
country prior to expiration of such Royalty Term.

 

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8.2.       Termination
for Convenience by Licensee. Upon at sixty (60) days’ prior written notice to OSI, Licensee may terminate this
Agreement in its entirety without cause.

 

8.3.       Termination
for Default or Breach.

 

8.3.1.       Non-Payment.
In the event that Licensee fails to pay any undisputed amounts due and payable to OSI, and fails to make such payments within (***)
after receiving written notice of such failure, OSI may terminate this Agreement in its entirety immediately upon written notice
to Licensee.

 

8.3.2.       Material
Breach. Except for a breach as described in Section 8.3.1, in the event either Party commits a material breach of its
obligations under this Agreement (including, for the avoidance of doubt, a breach of a party’s Diligence Obligations), and
fails to cure that breach within (***)after receiving notice thereof from the other Party, the non-breaching Party may terminate
this Agreement in its entirety immediately after the aforesaid (***)period by written notice to the breaching Party.

 

8.4.       Patent
Challenge. If Licensee or any of its Affiliates or Sublicensees (or any Affiliates of such Sublicensees), brings a Patent
Challenge, or assists in bringing a Patent Challenge (except (a) as required under a court order or subpoena or (b) as a defense
against a claim, action or proceeding asserted by OSI or its licensees against Licensee or any of its Affiliates or Sublicensees),
then OSI may immediately terminate this Agreement in its entirety.

 

8.5.       Insolvency.
Either Party may terminate this Agreement immediately upon written notice to the other Party, if the other Party (a) becomes
generally unable to pay, or fails to pay, its debts as they become due, (b) files, or has filed against it, a petition for voluntary
or involuntary bankruptcy or pursuant to any other insolvency law, (c) makes or seeks to make a general assignment for the benefit
of its creditors, or (d) applies for, or consents to, the appointment of a trustee, receiver or custodian for a substantial part
of its property or business.

 

8.6.       Termination
Disputes. If a Party gives notice of default, termination, or failure to pay any undisputed amounts under Section 8.3
(the “Non-Breaching Party”) and the other Party (the “Breaching Party”) disagrees with the
Non-Breaching Party’s assertion of default or right to terminate the Agreement, then the Agreement shall remain in full force
and effect until the dispute is finally resolved pursuant to the dispute resolution process set forth in Section 10.1. Any
cure period set forth in Section 8.3 shall be tolled upon the initiation of such dispute resolution process. If, as a result
of the dispute resolution process, it is determined pursuant to Section 10.1 that the Breaching Party committed a material
breach or default of this Agreement or a failure to pay any undisputed amounts under this Agreement, then the applicable cure period
shall resume, any undisputed amounts will accrue interest, as set forth in Section 3.5.5 from the original date in which
such amount was due, and if the Breaching Party does not cure such material breach or failure to pay such undisputed amount within
the remainder of the applicable cure period, then this Agreement will terminate effective as of the expiration of such cure period.
On the other hand, if as a result of the dispute resolution process, it is determined pursuant to Section 10.1 that the
Breaching Party did not commit a material breach or default of this Agreement or failure to pay any undisputed amounts under this
Agreement, then the Non-Breaching Party’s notice of default or termination will be rendered null and void, and the Agreement
will remain in full force and effect. This Agreement will remain in full force and effect during the pendency of any such dispute
resolution proceeding and the applicable cure period. Any such dispute resolution proceeding will not suspend any obligations of
either Party hereunder, and each Party will use reasonable efforts to mitigate any damage.

 

    	 	24	 

     

    

  

8.7.       Effects
of Termination.

 

8.7.1.       Survival.
The following sections, together with any sections that expressly survive, will survive expiration or termination of this Agreement
for any reason: Article 1 (Definitions); Section 2.4.4 (No Other Obligations); Section 3.5.1-3.5.2
and 3.5.4-3.5.5 (Reports and Payments) (solely with respect to payment obligations that have accrued prior to the
effective date of such expiration or termination); Section 3.5.3 (No Refunds); Section 3.5.6 (Financial Records and
Audits); Section 3.6 (No Deductions or Offsets); Section 5.1 (Inventorship); Section 6.1 (Confidentiality);
Section 6.2 (Authorized Disclosure); Section 6.3 (SEC Filings and Other Disclosures); Section 6.4.1 (Announcements);
Section 7.4 (Disclaimer); Section 8.7 (Effects of Termination); Article 9 (Limitation of Liability; Indemnification
and Insurance); Article 10 (Miscellaneous).

 

8.7.2.       Accrued
Rights. Expiration or termination of this Agreement for any reason will be without prejudice to any right which will have accrued
to the benefit of either Party prior to such termination, including damages arising from any breach under this Agreement. Expiration
or termination of this Agreement will not relieve either Party from any obligation which is expressly indicated to survive such
expiration or termination.

 

8.7.3.       Termination
of Licenses. Upon early termination of this Agreement for any reason, all rights and licenses granted to Licensee under the
terms of this Agreement will terminate; provided, however, that if Licensee terminates this Agreement in accordance
with Section 8.3.2, then Licensee and its Affiliates and Sublicensees may continue to distribute any inventory of Licensed
Product (to the extent existing in finished form or as work in progress as of the date that Licensee provides notice of termination
pursuant to Section 8.3.2) in the Field in the Territory, on a non-exclusive basis during the twelve (12) month period following
the effective date of termination for so long as Licensee makes all payments due in accordance with the terms and conditions set
forth in this Agreement, including the payment of royalties on any resulting Net Sales.

 

8.7.4.       Confidential
Information. Within thirty (30) days of the effective date of any early termination of this Agreement, each Party shall, at
the Disclosing Party’s option, either return or destroy all materials relating to or containing the other Party’s Confidential
Information, except to the extent such Confidential Information is necessary to perform surviving obligations or exercise surviving
rights. Notwithstanding the foregoing, the Receiving Party will be permitted to such copies of such data, files, records,
and other materials necessary for archival and legal compliance purposes, such copies to remain subject to Article 6 and
neither Party shall be required to delete Confidential Information of the Disclosing Party stored pursuant to such Party’s
automated electronic backup systems so long as it is destroyed in accordance with such Party’s document retention policy.

 

    	 	25	 

     

    

  

8.7.5.       Reversion.
In addition to the other applicable effects of termination set forth under this Agreement, upon termination of the Agreement by
(A) OSI pursuant to Section 8.3 in the event of an uncured material breach or non-payment by Licensee or pursuant to Section
8.5 in the event of Licensee’s insolvency or (B) Licensee pursuant to Section 8.2 for convenience, in each case
of clauses (A) and (B), upon OSI’s request:

 

(a)       Licensee
will and hereby does grant OSI an exclusive, royalty-free, fully paid-up, sublicensable (through multiple tiers), perpetual, irrevocable
license under all Patents and Know-How Controlled by Licensee or its Affiliates that (i) claim, Cover or are incorporated into
one or more Licensed Products or (ii) were otherwise used or practiced in the Development, Manufacture, Commercialization or exploitation
of the Licensed Products on or prior to the effective date of termination (collectively, the “Licensee Product Technology”)
to research, develop, make, have made, use, keep, sell, offer for sale, import, perform and practice and otherwise exploit any
pharmaceutical product comprised of or containing a Compound as an active pharmaceutical ingredient, in all forms, presentations,
formulations and dosage forms, in the Field in the Territory;

 

(b)       Licensee
will promptly transfer to OSI all tangible embodiments of the Know-How in the Licensee Product Technology, the costs of which transfer
will be borne by Licensee;

 

(c)       Licensee
will and hereby does transfer, convey and deliver to OSI, and OSI will and hereby does acquire from Licensee and agrees to perform
and discharge, all of Licensee’s right, title, interest and obligations in or under all Regulatory Documentation with respect
to Licensed Products. Licensee shall promptly submit to any applicable Regulatory Authorities all necessary documentation to transfer
and assign legal and record ownership of (i) all Regulatory Approvals for all Licensed Products and (ii) all submissions, documents
or other correspondence submitted to applicable Regulatory Authorities for Licensed Products in the Territory to OSI. Licensee
shall permit, and shall cause its Affiliates and Sublicensees to permit, OSI and its licensees to utilize, reference, cross reference,
incorporate in applications and filings, and otherwise have the benefit of all Regulatory Approvals of, or Clinical Trials or other
studies conducted on, and all filings made with Regulatory Authorities with respect to, all Licensed Products. Licensee hereby
grants to OSI, its Affiliates and its licensees a “Right of Reference,” as that term is defined in 21 C.F.R. §
314.3(b) (or any analogous Applicable Law recognized outside of the United States), to data (including any regulatory filings)
owned, possessed or otherwise Controlled by Licensee or its Affiliates as of the effective date of termination to the extent such
relates to the Compound or any Licensed Product in the Field in the Territory for the purposes of obtaining and maintaining Regulatory
Approval for Licensed Products in the Field in the Territory, and Licensee will provide a signed statement to this effect, if requested
by OSI, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous law outside of the United States);

 

    	 	26	 

     

    

  

(d)       the
Parties shall cooperate to transfer any ongoing Clinical Trials in the Territory (including any Clinical Trials initiated following
Regulatory Approval and any patient registry or other collection of patient data) in an orderly manner to OSI as promptly as reasonably
practicable following such termination or expiration, with each Party bearing its own costs in relation to such transfer. Prior
to the completion of such transfer, Licensee shall continue at its expense to conduct such Clinical Trials in a manner designed
to avoid any disruption of or delay in the completion of any such Clinical Trial;

 

(e)       To
the extent that, as of the effective date of termination of this Agreement, Licensee, its Affiliates or Sublicensees has existing
and ongoing contracts with Third Parties related to the Development, Manufacture or Commercialization of any Licensed Product(s),
at the written request of OSI, Licensee will use, and will cause its Affiliates and Sublicensees to use, good faith commercially
reasonable efforts to transfer such contracts and arrangements to OSI, including using good faith commercially reasonable efforts
to assign contracts and arrangements to OSI in part or facilitate separate arrangements with OSI if such contracts and arrangements
relate to more than solely the Licensed Product(s);

 

(f)       With
respect to quantities of Licensed Product not sold by Licensee under Section 8.7.3, at OSI’s written request, Licensee
shall deliver such quantities of the applicable Licensed Product(s) that Licensee or any of its Affiliates has in its respective
inventory or control (including inventory in its control on the premises of a Third Party subcontractor) as of the date of OSI’s
request and OSI shall reimburse Licensee at Licensee’s reasonable cost of goods for such Licensed Product(s);

 

(g)       Licensee
shall supply to OSI such reasonable quantities of Licensed Product(s) as OSI indicates in written forecasts and orders from time
to time, until the earlier of (i) such time as OSI has established an alternative, validated source of supply for such Licensed
Product(s) and (ii) the second anniversary of the effective date of termination of this Agreement. The costs to OSI for supply
of such Licensed Product(s) from Licensee shall be equal to Licensee’s reasonable cost of goods for such Licensed Product(s).
Notwithstanding anything to the contrary in this Agreement, if any such Licensed Product is manufactured for Licensee by a Third
Party contract manufacturer pursuant to a written contract, then Licensee may satisfy its obligations pursuant to this Section
8.7.5(g) with respect to such Licensed Product by assigning its rights and obligations under such contract (or the portion
of such contract pertaining to such Licensed Product) to OSI; and

 

    	 	27	 

     

    

  

(h)       Licensee
shall for one (1) year from the effective date of termination, at the written request and expense of OSI, provide OSI with such
assistance as is reasonably necessary to effectuate a smooth and orderly transition to OSI or its designee of any Development,
Manufacture and Commercialization activities relating to the applicable Licensed Product(s) so as to minimize the disruption of
such activities, provided, however, that Licensee shall not be obligated to initiate any new substantive activity,
distinct from any previously ongoing substantive activity, that would itself create any new obligations on the part of Licensee
that would continue following such termination. Further, upon OSI’s written request, for one (1) year from the effective
date of termination, Licensee shall make its personnel reasonably available to provide such technical assistance, as may reasonably
be requested to transfer all Manufacturing technology Controlled by Licensee or its Affiliates that is or had been used by or on
behalf of Licensee and its Affiliates in connection with the Manufacture of any Licensed Product. All activities under this Section
8.7.5(h) shall be at no cost to OSI except for reimbursement of Licensee’s direct out-of-pocket costs therefor; provided
that if this Agreement has been terminated by Licensee under Section 8.2 or by OSI under Section 8.3, 8.4
or 8.5, OSI will have no obligation to so reimburse Licensee.

 

		9.	LIMITATION OF LIABILITY, INDEMNIFICATION AND INSURANCE.

 

9.1.       Limitation
of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, NEITHER PARTY WILL BE LIABLE TO THE OTHER
PARTY HEREUNDER FOR ANY INDIRECT, PUNITIVE, SPECIAL OR CONSEQUENTIAL DAMAGES, OR FOR LOST PROFITS (WHETHER DIRECT OR INDIRECT),
EVEN IF SUCH PARTY HAS BEEN INFORMED OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES OR LOST PROFITS, PROVIDED, HOWEVER,
THAT THIS SECTION 9.1 SHALL NOT LIMIT OR RESTRICT (A) DAMAGES AVAILABLE TO A PARTY FOR BREACHES BY THE OTHER PARTY OF ITS
CONFIDENTIALITY AND NON-USE OBLIGATIONS SET FORTH IN ARTICLE 6, (B) DAMAGES AVAILABLE FOR WILLFUL MISCONDUCT OR GROSS NEGLIGENCE,
OR (C) THE INDEMNIFICATION OBLIGATIONS OF EITHER PARTY PURSUANT TO THIS ARTICLE 9.

 

9.2.       Indemnification
by Licensee. Licensee will indemnify, defend and hold harmless OSI and its Representatives (each, an “OSI Indemnified
Party”), and shall cause any and all Sublicensees to indemnify, defend and hold harmless the OSI Indemnified Parties,
from and against any and all claims, causes, or allegations (whether threatened or pending), judgments, expenses, damages, liabilities,
obligations, fees (including the reasonable fees of attorneys and other consulting or testifying professionals), costs and losses
(collectively, “Liabilities”) that the OSI Indemnified Party may be required to pay to one or more Third Parties
arising out of or related to: (a) the exercise of any rights granted to Licensee under this Agreement, including the Development,
Manufacture, Commercialization or other exploitation or use of any Compound or Licensed Product by, on behalf of, or under the
authority of, Licensee, any of its Affiliates, any of its Sublicensees or any of their respective Representatives (including Liabilities
arising out of or resulting from any theory of product liability concerning any Licensed Product Developed, Manufactured, Commercialized
or used by Licensee, any of its Affiliates, any of its Sublicensees or any of their respective Representatives pursuant to any
right or licensed granted under this Agreement); (b) the negligence, gross negligence or willful misconduct of Licensee or any
of its Representatives in performing under this Agreement or with respect to the Compound or Licensed Product; and (c) the breach
by Licensee of any representation, warranties, covenant or agreement made by Licensee under this Agreement, except, in each case
of clauses (a) through (c), to the extent caused by claims for which OSI is required to indemnify Licensee pursuant to Section
9.3.

 

    	 	28	 

     

    

  

9.3.       Indemnification
by OSI. OSI will indemnify, defend and hold harmless Licensee and its Representatives (each, a “Licensee Indemnified
Party”) from and against any and all Liabilities that the Licensee Indemnified Party may be required to pay to one or
more Third Parties arising out of or related to: (a) the breach by OSI or any of its Representatives any representation, warranties,
covenant or agreement made by OSI under this Agreement; or (b) the negligence, gross negligence or willful misconduct of OSI or
any of its Representatives in performing under this Agreement, except, in each case of clause (a) and (b) to the extent caused
by claims for which Licensee is required to indemnify OSI pursuant to Section 9.2.

 

9.4.       Procedure.
Each Party will notify the other Party in writing if it becomes aware of a claim for which indemnification may be sought hereunder.
In case any proceeding (including any governmental investigation) will be instituted involving any Party in respect of which indemnity
may be sought pursuant to this Article 9, such Party (the “Indemnified Party”) will give prompt written
notice of the indemnity claim to the other Party (the “Indemnifying Party”) and provide the Indemnifying Party
with a copy of any complaint, summons or other written or verbal notice that the Indemnified Party receives in connection with
any such claim. An Indemnified Party’s failure to deliver notice will relieve the Indemnifying Party of liability to the
Indemnified Party under this Article 9 only to the extent such delay is prejudicial to the Indemnifying Party’s ability
to defend such claim. Provided that the Indemnifying Party is not contesting the indemnity obligation, the Indemnified Party will
permit the Indemnifying Party to control any litigation relating to such claim and the disposition of such claim by negotiated
settlement or otherwise and any failure to contest prior to assuming control will be deemed to be an admission of the obligation
to indemnify. The Indemnifying Party will act reasonably and in good faith with respect to all matters relating to such claim and
will not settle or otherwise resolve such claim without the Indemnified Party’s prior written consent which will not be withheld,
delayed or conditioned unreasonably; provided, that such consent will not be required with respect to any settlement involving
only the payment of monetary awards for which the Indemnifying Party will be fully-responsible. The Indemnified Party will cooperate
with the Indemnifying Party in the Indemnifying Party’s defense of any claim for which indemnity is sought under this Agreement,
at the Indemnifying Party’s cost and expense.

 

9.5.       Insurance.
Licensee, at its own expense, shall maintain product liability and other appropriate insurance (or self-insure sufficiently to
provide materially the same level and type of protection) in an amount consistent with sound business practice and adequate in
light of its obligations under this Agreement during the Term. Licensee shall provide a certificate of insurance (or evidence of
self-insurance) evidencing such coverage to OSI upon request. Licensee’s insurance will not be construed to create a limit
of liability with respect to its indemnification obligations under this Article 9.

 

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		10.	MISCELLANEOUS.

 

10.1.       Disputes.
Upon the written request of either Party to the other Party, any claim, dispute, or controversy as to the breach, enforcement,
interpretation or validity of this Agreement (other than any dispute the resolution of which is within the express authority of
a Party hereunder), including any action or claim based on tort, contract, or statute, or concerning the interpretation, effect,
termination, validity, performance or breach of this Agreement, will be referred to (a) the Chief Executive Officer of Licensee
or his or her designee, and (b) the VP Business Development of OSI or his or her designee (collectively ((a) and (b)), the “Senior
Officers”) for resolution. In the event the Senior Officers are unable to resolve such dispute within 30 days after the
initial written request, then, either Party will have the right to pursue any and all remedies available at law or equity, consistent
with Section 10.11. The provisions of this Section 10.1 will survive for five (5) years from the date of termination
or expiration of this Agreement.

 

10.2.       Assignment.
Neither this Agreement nor any interest hereunder will be assignable by Licensee without the prior written consent of OSI, except
as follows: following the first anniversary of the Effective Date, (a) Licensee may assign its rights and obligations under this
Agreement in connection with the transfer or sale of all or substantially all of the business or assets of Licensee relating to
the Compound to a Third Party, whether by merger, consolidation, divesture, restructure, sale of stock, sale of assets or otherwise
and (b) Licensee may assign its rights and obligations under this Agreement to any of its Affiliates, provided that the
assignee will expressly agree to be bound by Licensee’s obligations under this Agreement and that Licensee will remain liable
for all of its rights and obligations under this Agreement. OSI may assign or transfer any of its rights or obligations under this
Agreement without Licensee’s prior written consent. Each Party will promptly notify the other Party of any assignment or
transfer under the provisions of this Section 10.1. This Agreement will be binding upon the successors and permitted assigns
of the Parties and the name of a Party appearing herein will be deemed to include the names of such Party’s successors and
permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this
Section 10.1 will be void.

 

10.3.       Further
Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts,
as may be necessary or appropriate in order to carry out the purposes and intent of the Agreement.

 

10.4.       Interpretation.
Except where the context expressly requires otherwise, (a) the use of any gender herein will be deemed to encompass references
to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa), (b) the words
“include”, “includes” and “including” will be deemed
to be followed by the phrase “without limitation”, (c) the word “will”
will be construed to have the same meaning and effect as the word “shall”, (d) any definition of
or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument
or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments,
supplements or modifications set forth herein), (e) any reference herein to any Person will be construed to include the Person’s
successors and assigns, (f) the words “herein”, “hereof” and “hereunder”,
and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof,
(g) all references herein to Sections, or Schedules will be construed to refer to Sections or Schedules of this Agreement, and
references to this Agreement include all Schedules hereto, (h) the word “notice” means notice in writing
(whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated
under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree,”
“consent” or “approve” or the like will require that such agreement, consent or
approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail
and instant messaging), (j) references to any specific law, rule or regulation, or article, section or other division thereof,
will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof,
and (k) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or.”

 

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10.5.       Notices.
Any notice to be given under this Agreement must be in writing and delivered either in person, by (a) air mail (postage prepaid)
requiring return receipt, (b) overnight courier, or (c) email or facsimile confirmed thereafter by any of the foregoing, to the
party to be notified at its address(es) given below, or at any address such party may designate by prior written notice to the
other in accordance with this Section 10.5. Notice shall be deemed sufficiently given for all purposes upon the earliest
of: (i) the date of actual receipt; (ii) if air mailed, five days after the date of postmark; (iii) if delivered by overnight courier,
the next day the overnight courier regularly makes deliveries; or (iv) if emailed or sent by facsimile, the date of confirmation
of receipt if during the recipient’s normal business hours, otherwise the next day.

 

All correspondence
to Licensee will be addressed as follows:

 

Aevi Genomic Medicine, Inc.

435 Devon Park Drive, Suite 715

Wayne, PA 19087

Attention: Chief Executive Officer

 

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

 

Pepper Hamilton LLP

3000 Two Logan Square

Eighteenth And Arch Streets

Philadelphia,  PA  19103-2799

Attention: Brian M. Katz

Facsimile: +1-215-981-4750

 

All correspondence to OSI will be addressed
as follows:

 

OSI Pharmaceuticals, LLC

1 Astellas Way

Northbrook, IL 60062, U.S.A.

Attention: President

Facsimile: +1-224-205-5909

    	 	31	 

     

    

 

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

 

Astellas US LLC

1 Astellas Way

Northbrook, IL 60062, U.S.A.

Attention: General Counsel

Facsimile: +1-224-205-5909

 

10.6.       Amendment.
No amendment, modification or supplement of any provision of this Agreement will be valid or effective unless made in writing and
signed by a duly authorized officer of each Party.

 

10.7.       Waiver
and Non-Exclusion of Remedies. No provision of this Agreement will be waived by any act, omission or knowledge of a
Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized
officer of the waiving Party. The waiver by either of the Parties of any breach of any provision hereof by the other Party will
not be construed to be a waiver of any succeeding breach of such provision or a waiver of the provision itself. The rights and
remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available
except as expressly set forth herein.

 

10.8.       Severability.
If any clause or portion thereof in this Agreement is for any reason held to be invalid, illegal or unenforceable, the same will
not affect any other portion of this Agreement, as it is the intent of the Parties that this Agreement will be construed in such
fashion as to maintain its existence, validity and enforceability to the greatest extent possible. In any such event, this Agreement
will be construed as if such clause of portion thereof had never been contained in this Agreement, and there will be deemed substituted
therefor such provision as will most nearly carry out the intent of the Parties as expressed in this Agreement to the fullest extent
permitted by Applicable Law.

 

10.9.       Nature
of Licenses.  All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to
be, for purposes of 11 U.S.C. § 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property”
as defined under 11 U.S.C. § 101(35A) of the Bankruptcy Code. The Parties agree that Licensee, as a licensee of such rights
under this Agreement, shall retain and may fully exercise all of its rights, including any right to enforce any exclusivity provision
of this Agreement, remedies, and elections under Applicable Law. To the fullest extent permitted by Applicable Law, the Parties
further agree that, in the event of the commencement of a bankruptcy proceeding by or against OSI under the Bankruptcy Code, Licensee
shall be entitled to all applicable rights under 11 U.S.C. § 365(n) of the Bankruptcy Code, including copies and access to,
as appropriate, any such intellectual property and all embodiments of such intellectual property upon written request therefor
by Licensee, and such, if not already in its possession, shall be promptly delivered to Licensee.

 

10.10.       Descriptive
Headings. The descriptive headings of this Agreement are for convenience only and will be of no force or effect in construing
or interpreting any of the provisions of this Agreement.

 

    	 	32	 

     

    

  

10.11.       Governing
Law; Jurisdiction and Service. This Agreement is governed by, and all disputes arising under or in connection with this
Agreement shall be resolved in accordance with, the laws of the State of New York, without regard to conflict of law principles
thereof. Each Party irrevocably submits to the exclusive jurisdiction of (a) the Supreme Court of the State of New York, New York
County, and (b) the United States District Court for the Southern District of New York, for the purposes of any suit, action, or
other proceeding arising out of this Agreement or out of any transaction contemplated hereby and the appeals courts therefrom.
Each Party agrees to commence any such action, suit, or proceeding either in the United States District Court for the Southern
District of New York or if such suit, action, or other proceeding may not be brought in such court for jurisdictional reasons,
in the Supreme Court of the State of New York, New York County. Each Party irrevocably and unconditionally waives any objection
to the laying of venue of any action, suit, or proceeding arising out of this Agreement or the transactions contemplated hereby
in (i) the Supreme Court of the State of New York, New York County or (ii) the United States District Court for the Southern District
of New York, and hereby and thereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such
court that any such action, suit, or proceeding brought in any such court has been brought in an inconvenient forum. Each Party
further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section
10.5 shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any
such court.

 

10.12.       Use
of Names. Neither Party shall, without the prior written consent of the other Party, use the name or any trademark or
trade name owned by the other Party, or owned by an affiliate or parent corporation of the other Party, in any publication, publicity,
advertising, or otherwise, except as expressly permitted by Article 6.

 

10.13.       Entire
Agreement. This Agreement constitutes and contains the complete, final and exclusive understanding and agreement of
the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral
or written, between the Parties respecting the subject matter hereof and thereof, including the Prior CDA, which is hereby terminated
effective as of the Effective Date.

 

10.14.       Independent
Contractors. Both Parties are independent contractors under this Agreement. Nothing herein contained will be deemed
to create an employment, agency, joint venture or partnership relationship between the Parties hereto or any of their agents or
employees, or any other legal arrangement that would impose liability upon one Party for the act or failure to act of the other
Party. Neither Party will have any express or implied power to enter into any contracts or commitments or to incur any liabilities
in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.

 

10.15.       Counterparts.
This Agreement may be executed in two (2) counterparts, each of which will be an original and both of which will constitute together
the same document. Counterparts may be signed and delivered by facsimile or digital (e.g., PDF) file, each of which will be binding
when received by the applicable Party.

 

10.16.       No
Third Party Rights or Obligations. No provision of this Agreement will be deemed or construed in any way to result in
the creation of any rights or obligation in any Person not a Party to this Agreement.

 

[Signature page follows.]

 

    	 	33	 

     

    

 

[Signature Page to Exclusive License
Agreement]

 

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

  

	
        OSI PHARMACEUTICALS, LLC

         
	 	AEVI GENOMIC MEDICINE, INC.
	By:	/s/ Percival Banetto-ko

	 	By:	/s/ Michael F. Cola
	
        Name: Percival Banetto-ko

        
	 	
        Name: Michael F. Cola

        

	Title: President	 	Title: Chief Executive Officer

 

     

     

    

 

SCHEDULE 1

 

OSI PRODUCT KNOW-HOW

 

Regulatory Documentation set forth on Schedule 5.

 

		1.	Program Overview

mgc1101266-cli-en-final-03_OSI.pdf

 

		2.	Intellectual_Property

Patent List.pdf

Recorded Assignment for US 11 599663.pdf

Recorded Assignments for US 60 737581 and 60 854264.PDF

 

		3.	Non-clinical

7486-me-1001-ncr-en-final-02.pdf

7486-me-1002-ncr-en-final-03.pdf

7486-me-1004-ncr-en-final-02.pdf

7486-ph-0001-ncr-en-final-02.pdf

7486-ph-001-ncr-en-final-02.pdf

7486-ph-002-ncr-en-final-02.pdf

7486-ph-003-ncr-en-final-02.pdf

7486-ph-004-ncr-en-final-02.pdf

A2007082-VR1 Validation Report and Amendments.pdf

A2007130-VR1 Validation Report and Amendments.pdf

A2007143 FINAL Report and Addendum (27-Oct-2008).pdf

A2008069-VR1 Validation Report and Amendments.pdf

I2008232 FINAL Report.pdf

M2007025 FINAL Report (22-May-2007).pdf

P2006349 FINAL Report.pdf

P2007006 FINAL AMENDED Report (09-Sep-2008).pdf

P2007006 FINAL Report (11-Aug-2008).pdf

P2007006 FINAL TK Subreport (25-Sep-2007).pdf

P2007041 FINAL Report (22-Oct-2008).pdf

P2007051 FINAL Report (19-Aug-2009).pdf

P2007074 FINAL Report (05-Sep-2008).pdf

R2006258 FINAL Biomarker Report (11-May-2007).pdf

R2006258 FINAL Report (31-Jan-2007).pdf

R2007007 FINAL Report (15-Oct-2007.pdf

R2007022 FINAL Report.pdf

R2007040 FINAL OSI Bioanalytical Report (14-Apr-2010).pdf

R2007040 FINAL Report (23-Oct-2009) and AMENDMENT (03-10-201.pdf

R2007042 FINAL Report.pdf

R2007043 FINAL Report (29-Oct-2008).pdf

R2007052 FINAL Report (22-Oct-2008).pdf

R2007053 FINAL Report (22-Oct-2008).pdf

R2007056 FINAL Report (27-Aug-2008).pdf

R2007110 FINAL Report.pdf

R2007131 (OP-0701) Live-phase Report.pdf

R2007131 FINAL Biomarker Report (15-Jan-2009).pdf

R2007131 FINAL Report.pdf

R2008231 AMENDED FINAL Report.pdf

R2008231, 260, 290, and 291 Live Phase Report (13-Oct-2008).pdf

R2008260 FINAL Report.pdf

R2008290 FINAL Report.pdf

 

     

     

    

  

R2008291 FINAL Report.pdf

R2009062 FINAL Report.pdf

R2010212 FINAL Report (27-Jan-2011).pdf

V2006283 Result Table.pdf

V2006350 (OSI-027).pdf

V2007054 FINAL Report (14-Aug-2008).pdf

V2007055 FINAL Report (28-Jul-2008).pdf

V2007061 FINAL Report (09-Aug-2006).pdf

V2007076 FINAL Report (18-Jul-2008).pdf

V2007150 FINAL Report.pdf

V2007151 FINAL Report.pdf

V2007156 FINAL Report.pdf

V2008189 FINAL Report (03-Oct-2008).pdf

V2009260 FINAL Report (13-Jan-2011).pdf

V2010151 FINAL Report.pdf

 

		4.	Clinical

7486-cl-0101-clr-en-final-02.pdf

 

		5.	Regulatory

ASP7486_IND103792_FDA Correspondence Index.pdf

IND (103,792)

3-2-p-1-description-and-composition.pdf_09ad3501801940de.pdf

32p41-capsule.pdf_09ad3501801940d7.pdf

32p41-contr-excip-specifications.pdf_09ad3501800f7891.pdf

3-2-p-4-1-specifications.pdf_09ad3501801940e5.pdf

3-2-p-4-2-analytical-procedures.pdf_09ad3501801940e6.pdf

32p42-contr-excip-analytical-proc.pdf_09ad3501800f7892.pdf

32p43-contr-excip-val-anal-proc.pdf_09ad3501800f7893.pdf

32p44-contr-excip-just-of-spec.pdf_09ad3501800f7894.pdf

3-2-p-4-5-excipients-human-animal.pdf_09ad3501801940e7.pdf

32P51-~1\3-2-p-5-1-specifications.pdf_09ad3501801940e9.pdf

3-2-p-5-2-analytical-procedure.pdf_09ad3501801940ea.pdf

32p52-contr-drug-prod-anal-proc.pdf_09ad3501800f7898.pdf

32p53-capsule.pdf_09ad3501801940da.pdf

3-2-p-5-4-batch-analyses.pdf_09ad3501801940ec.pdf

32p54-capsule.pdf_09ad3501801940db.pdf

32p54-contr-drug-prod-batch-anal.pdf_09ad3501800f789a.pdf

3-2-p-5-5-characterisation-impurities.pdf_09ad3501801940ed.pdf

32p55-contr-drug-prod-char-of-imp.pdf_09ad3501800f789b.pdf

32p56-contr-drug-prod-just-of-spec.pdf_09ad3501800f789c.pdf

3-2-p-5-6-justification-of-specification.pdf_09ad3501801940ee.pdf

3-2-p-7-container-closure-system.pdf_09ad3501801940f0.pdf

3-2-s-2-2-manuf-process-and-controls.pdf_09ad3501801940f4.pdf

3-2-s-2-3-control-of-materials.pdf_09ad3501801940f5.pdf

3-2-s-2-6-manuf-process-development.pdf_09ad3501801940f6.pdf

32s41-control-specification.pdf_09ad3501800f78af.pdf

3-2-s-4-1-specification.pdf_09ad3501801940f9.pdf

3-2-s-4-2-analytical-procedure.pdf_09ad3501801940fa.pdf

32s42-control-analytical-proc.pdf_09ad3501800f78b0.pdf

32s43-control-validation-anal-proc.pdf_09ad3501800f78b1.pdf

3-2-s-4-4-batch-analyses.pdf_09ad3501801940fc.pdf

32s44-control-batch-analys.pdf_09ad3501800f78b2.pdf

32s45-control-just-of-spec.pdf_09ad3501800f78b3.pdf

3-2-s-5-reference-standards.pdf_09ad3501801940fd.pdf

3-2-s-6-container-closure-system.pdf_09ad3501801940fe.pdf

 

     

     

    

 

7486-cl-0101-clp-en-am10-sam10-12.pdf_09ad3501801b56da.pdf

Correspondence\20081222\0000\index.xml_09ad3501800f7c2f.xml

Correspondence\20081222\0000\index-md5.txt_09ad3501800f7c2e.txt

Correspondence\20081222\0000\m1\us\12-22-2008-cover-letter.pdf_09ad3501800f7c06.pdf

Correspondence\20081222\0000\m1\us\12-22-2008-pre-ind-briefing-doc.pdf_09ad3501800f7c07.pdf

Correspondence\20081222\0000\m1\us\us-regional.xml_09ad3501800f7c08.xml

Correspondence\20081222\0000\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7c09.dtd

Correspondence\20081222\0000\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7c0a.dtd

Correspondence\20081222\0000\util\dtd\us-regional-v2-01.dtd_09ad3501800f7c0b.dtd

Correspondence\20081222\0000\util\style\ectd-2-0.xsl_09ad3501800f7c2a.xsl

Correspondence\20081222\0000\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7c2b.xsl

Correspondence\20081222\0000\util\style\us-regional.xsl_09ad3501800f7c2c.xsl

Correspondence\20081222\0000\util\style\valid-values.xml_09ad3501800f7c2d.xml

Correspondence\20090130\0001\index.xml_09ad3501800f7c44.xml

Correspondence\20090130\0001\index-md5.txt_09ad3501800f7c43.txt

Correspondence\20090130\0001\m1\us\cover-letter.pdf_09ad3501800f7c30.pdf

Correspondence\20090130\0001\m1\us\pre-ind-meeting-cancellation-letter.pdf_09ad3501800f7c31.pdf

Correspondence\20090130\0001\m1\us\us-regional.xml_09ad3501800f7c32.xml

Correspondence\20090130\0001\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7c33.dtd

Correspondence\20090130\0001\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7c3d.dtd

Correspondence\20090130\0001\util\dtd\us-regional-v2-01.dtd_09ad3501800f7c3e.dtd

Correspondence\20090130\0001\util\style\ectd-2-0.xsl_09ad3501800f7c3f.xsl

Correspondence\20090130\0001\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7c40.xsl

Correspondence\20090130\0001\util\style\us-regional.xsl_09ad3501800f7c41.xsl

Correspondence\20090130\0001\util\style\valid-values.xml_09ad3501800f7c42.xml

Correspondence\20120917.pdf_09ad35018018cf19.pdf

Correspondence\FlySheet_ASP7486_IND103792_CORRES.xls_09ad3501800f7c94.xls

Correspondence\Historical IND Correspondence\OSI-027—IND-103792-093010-041811-SN0018-SN0034—VOL02OF02.pdf_09ad350180125ea9.pdf

Correspondence\Historical IND Correspondence\OSI-027—IND-103792-100308-082010-SN0000-SN0016—VOL01OF02.pdf_09ad350180125eb4.pdf

protocol-101-incamend10.pdf_09ad3501801b56fd.pdf

protocol-101-v9-incamend8.pdf_09ad350180115a45.pdf

Serial\0002\index.xml_09ad3501800f790a.xml

Serial\0002\index-md5.txt_09ad3501800f7909.txt

Serial\0002\m1\us\11214-environ-analysis.pdf_09ad3501800f7807.pdf

Serial\0002\m1\us\1139-general-invest-plan.pdf_09ad3501800f7808.pdf

Serial\0002\m1\us\11442-invest-drug-labeling.pdf_09ad3501800f7809.pdf

Serial\0002\m1\us\1571.pdf_09ad3501800f780a.pdf

Serial\0002\m1\us\3674.pdf_09ad3501800f780b.pdf

Serial\0002\m1\us\cover-letter.pdf_09ad3501800f780c.pdf

Serial\0002\m1\us\fda-responses-to-pre-ind-questions.pdf_09ad3501800f780d.pdf

Serial\0002\m1\us\osi-027-ib.pdf_09ad3501800f7879.pdf

Serial\0002\m1\us\osi-027-ib-sum-changes.pdf_09ad3501800f780e.pdf

Serial\0002\m1\us\osi-acceptance-of-pre-ind-meeting-date.pdf_09ad3501800f787a.pdf

Serial\0002\m1\us\pre-ind-meeting-request.pdf_09ad3501800f787c.pdf

Serial\0002\m1\us\pre-ind-meeting-request-granted.pdf_09ad3501800f787b.pdf

Serial\0002\m1\us\us-regional.xml_09ad3501800f787d.xml

Serial\0002\m2\22-intro\22-intro-statement.pdf_09ad3501800f787e.pdf

Serial\0002\m2\23-qos\23-introduction.pdf_09ad3501800f787f.pdf

Serial\0002\m2\23-qos\23p-dpcmcsum.pdf_09ad3501800f7880.pdf

Serial\0002\m2\23-qos\23s-dscmcsum.pdf_09ad3501800f7881.pdf

Serial\0002\m2\24-nonclin-over\24-nonclinical-overview.pdf_09ad3501800f7882.pdf

Serial\0002\m2\25-clin-over\25-clinical-overview.pdf_09ad3501800f7883.pdf

Serial\0002\m2\26-nonclin-sum\261-nonclinical-introduction.pdf_09ad3501800f7884.pdf

Serial\0002\m2\26-nonclin-sum\262-263-nonclinical-pharm.pdf_09ad3501800f7885.pdf

 

     

     

    

  

Serial\0002\m2\26-nonclin-sum\264-265-nonclinical-pk.pdf_09ad3501800f7886.pdf

Serial\0002\m2\26-nonclin-sum\266-267-nonclinical-tox.pdf_09ad3501800f7887.pdf

Serial\0002\m2\27-clin-sum\27-clinical-summary.pdf_09ad3501800f7888.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p1-desc-comp\32p1-description-and-composition.pdf_09ad3501800f7889.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p2-pharm-dev\32p21-pharm-dev-comp-drug-product.pdf_09ad3501800f788a.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p2-pharm-dev\32p22-pharm-dev-drug-product.pdf_09ad3501800f788b.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p3-manuf\32p31-manuf-manufacturers.pdf_09ad3501800f788c.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p3-manuf\32p32-manuf-batch-formula.pdf_09ad3501800f788d.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p3-manuf\32p33-manuf-process-and-controls.pdf_09ad3501800f788e.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p3-manuf\32p34-manuf-control-critical-steps.pdf_09ad3501800f788f.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p3-manuf\32p35-manuf-process-evaluation.pdf_09ad3501800f7890.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p4-contr-excip\32p45-contr-excip-ex-of-hu-an-or.pdf_09ad3501800f7895.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p4-contr-excip\32p46-contr-excip-novel-excipients.pdf_09ad3501800f7896.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p5-contr-drug-prod\32p51-spec\32p51-contr-drug-prod-spec.pdf_09ad3501800f7897.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p5-contr-drug-prod\32p53-val-analyt-proc\32p53-val-analyt-proc.pdf_09ad3501800f7899.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p6-ref-stand\32p6-reference-standards.pdf_09ad3501800f789d.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p7-cont-closure-sys\32p7-container-closure-system.pdf_09ad3501800f789e.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p8-stab\32p81-stability-stability-summary.pdf_09ad3501800f789f.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p8-stab\32p82-stability-postapproval-stab.pdf_09ad3501800f78a0.pdf

Serial\0002\m3\32-body-data\32p-drug-prod\osi-027-capsule-5-mg—20-mg\32p8-stab\32p83-stability-stability-data.pdf_09ad3501800f78a1.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s1-gen-info\32s11-gen-info-nomenclature.pdf_09ad3501800f78a2.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s1-gen-info\32s12-gen-info-structure.pdf_09ad3501800f78a3.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s1-gen-info\32s13-gen-info-properties.pdf_09ad3501800f78a4.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s2-manuf\32s21-manuf-manufacturer.pdf_09ad3501800f78a5.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s2-manuf\32s22-manuf-process-and-controls.pdf_09ad3501800f78a6.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s2-manuf\32s23-manuf-control-of-materials.pdf_09ad3501800f78a7.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s2-manuf\32s24-manuf-control-critical-steps.pdf_09ad3501800f78a8.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s2-manuf\32s25-manuf-process-validation.pdf_09ad3501800f78a9.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s2-manuf\32s26-manuf-process-development.pdf_09ad3501800f78aa.pdf

 

     

     

    

  

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s3-charac\32s31-charac-elucidation-of-struct.pdf_09ad3501800f78ad.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s3-charac\32s32-charac-impurities.pdf_09ad3501800f78ae.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s5-ref-stand\32s5-reference-standards.pdf_09ad3501800f78b4.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s6-cont-closure-sys\32s6-container-closure-system.pdf_09ad3501800f78b5.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s7-stab\32s71-stability-summary.pdf_09ad3501800f78b6.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s7-stab\32s72-stability-postapproval-stab.pdf_09ad3501800f78b8.pdf

Serial\0002\m3\32-body-data\32s-drug-sub\osi-027rp-cambridge-major-laboratories-inc\32s7-stab\32s73-stability-data.pdf_09ad3501800f78b9.pdf

Serial\0002\m4\42-stud-rep\421-pharmacol\4211-prim-pd\v2007061\stf-v2007061.xml_09ad3501800f78ba.xml

Serial\0002\m4\42-stud-rep\421-pharmacol\4211-prim-pd\v2007061\v2007061.pdf_09ad3501800f78bb.pdf

Serial\0002\m4\42-stud-rep\421-pharmacol\4213-safety-pharmacol\p2007051\p2007051.pdf_09ad3501800f78bc.pdf

Serial\0002\m4\42-stud-rep\421-pharmacol\4213-safety-pharmacol\p2007051\stf-p2007051.xml_09ad3501800f78bd.xml

Serial\0002\m4\42-stud-rep\421-pharmacol\4213-safety-pharmacol\r2007052\r2007052.pdf_09ad3501800f78be.pdf

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Serial\0011\m1\us\invest-letter-2009003635.pdf_09ad3501800f7ad0.pdf

Serial\0011\m1\us\us-regional.xml_09ad3501800f7ad1.xml

Serial\0011\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch-2009003635.pdf_09ad3501800f7ad2.pdf

Serial\0011\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7ad3.xml

Serial\0011\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7ad4.dtd

Serial\0011\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7ad5.dtd

Serial\0011\util\dtd\us-regional-v2-01.dtd_09ad3501800f7ad6.dtd

Serial\0011\util\style\ectd-2-0.xsl_09ad3501800f7ad7.xsl

Serial\0011\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7ad8.xsl

Serial\0011\util\style\us-regional.xsl_09ad3501800f7ad9.xsl

Serial\0011\util\style\valid-values.xml_09ad3501800f7ada.xml

Serial\0012\index.xml_09ad3501800f7aec.xml

Serial\0012\index-md5.txt_09ad3501800f7aeb.txt

Serial\0012\m1\us\1571.pdf_09ad3501800f7add.pdf

Serial\0012\m1\us\3674.pdf_09ad3501800f7ade.pdf

Serial\0012\m1\us\cover-letter.pdf_09ad3501800f7adf.pdf

Serial\0012\m1\us\us-regional.xml_09ad3501800f7ae0.xml

Serial\0012\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\1572.pdf_09ad3501800f7ae1.pdf

Serial\0012\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\lorusso-cv.pdf_09ad3501800f7ae2.pdf

 

     

     

    

 

Serial\0012\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7ae3.xml

Serial\0012\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7ae4.dtd

Serial\0012\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7ae5.dtd

Serial\0012\util\dtd\us-regional-v2-01.dtd_09ad3501800f7ae6.dtd

Serial\0012\util\style\ectd-2-0.xsl_09ad3501800f7ae7.xsl

Serial\0012\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7ae8.xsl

Serial\0012\util\style\us-regional.xsl_09ad3501800f7ae9.xsl

Serial\0012\util\style\valid-values.xml_09ad3501800f7aea.xml

Serial\0013\index.xml_09ad3501800f7afb.xml

Serial\0013\index-md5.txt_09ad3501800f7afa.txt

Serial\0013\m1\us\1571.pdf_09ad3501800f7aed.pdf

Serial\0013\m1\us\cover-letter.pdf_09ad3501800f7aee.pdf

Serial\0013\m1\us\inv-letter.pdf_09ad3501800f7aef.pdf

Serial\0013\m1\us\us-regional.xml_09ad3501800f7af0.xml

Serial\0013\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7af1.pdf

Serial\0013\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7af2.xml

Serial\0013\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7af3.dtd

Serial\0013\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7af4.dtd

Serial\0013\util\dtd\us-regional-v2-01.dtd_09ad3501800f7af5.dtd

Serial\0013\util\style\ectd-2-0.xsl_09ad3501800f7af6.xsl

Serial\0013\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7af7.xsl

Serial\0013\util\style\us-regional.xsl_09ad3501800f7af8.xsl

Serial\0013\util\style\valid-values.xml_09ad3501800f7af9.xml

Serial\0014\index.xml_09ad3501800f7b0a.xml

Serial\0014\index-md5.txt_09ad3501800f7b09.txt

Serial\0014\m1\us\1571.pdf_09ad3501800f7afc.pdf

Serial\0014\m1\us\cover-letter.pdf_09ad3501800f7afd.pdf

Serial\0014\m1\us\inv-letter.pdf_09ad3501800f7afe.pdf

Serial\0014\m1\us\us-regional.xml_09ad3501800f7aff.xml

Serial\0014\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7b00.pdf

Serial\0014\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7b01.xml

Serial\0014\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7b02.dtd

Serial\0014\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7b03.dtd

Serial\0014\util\dtd\us-regional-v2-01.dtd_09ad3501800f7b04.dtd

Serial\0014\util\style\ectd-2-0.xsl_09ad3501800f7b05.xsl

Serial\0014\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7b06.xsl

Serial\0014\util\style\us-regional.xsl_09ad3501800f7b07.xsl

Serial\0014\util\style\valid-values.xml_09ad3501800f7b08.xml

Serial\0015\index.xml_09ad3501800f7b1a.xml

Serial\0015\index-md5.txt_09ad3501800f7b19.txt

Serial\0015\m1\us\1571.pdf_09ad3501800f7b0b.pdf

Serial\0015\m1\us\cover-letter.pdf_09ad3501800f7b0c.pdf

Serial\0015\m1\us\inv-letter.pdf_09ad3501800f7b0d.pdf

Serial\0015\m1\us\us-regional.xml_09ad3501800f7b0e.xml

Serial\0015\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7b0f.pdf

Serial\0015\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7b10.xml

Serial\0015\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7b11.dtd

Serial\0015\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7b12.dtd

Serial\0015\util\dtd\us-regional-v2-01.dtd_09ad3501800f7b13.dtd

 

     

     

    

  

Serial\0015\util\style\ectd-2-0.xsl_09ad3501800f7b14.xsl

Serial\0015\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7b16.xsl

Serial\0015\util\style\us-regional.xsl_09ad3501800f7b17.xsl

Serial\0015\util\style\valid-values.xml_09ad3501800f7b18.xml

Serial\0016\index.xml_09ad3501800f7aa0.xml

Serial\0016\index-md5.txt_09ad3501800f7a9f.txt

Serial\0016\m1\us\1571.pdf_09ad3501800f7a92.pdf

Serial\0016\m1\us\cover-letter.pdf_09ad3501800f7a93.pdf

Serial\0016\m1\us\inv-let.pdf_09ad3501800f7a94.pdf

Serial\0016\m1\us\us-regional.xml_09ad3501800f7a95.xml

Serial\0016\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7a96.pdf

Serial\0016\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7a97.xml

Serial\0016\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7a98.dtd

Serial\0016\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7a99.dtd

Serial\0016\util\dtd\us-regional-v2-01.dtd_09ad3501800f7a9a.dtd

Serial\0016\util\style\ectd-2-0.xsl_09ad3501800f7a9b.xsl

Serial\0016\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7a9c.xsl

Serial\0016\util\style\us-regional.xsl_09ad3501800f7a9d.xsl

Serial\0016\util\style\valid-values.xml_09ad3501800f7a9e.xml

Serial\0017\index.xml_09ad3501800f7aaf.xml

Serial\0017\index-md5.txt_09ad3501800f7aae.txt

Serial\0017\m1\us\1571.pdf_09ad3501800f7aa1.pdf

Serial\0017\m1\us\cover-letter.pdf_09ad3501800f7aa2.pdf

Serial\0017\m1\us\inv-letter.pdf_09ad3501800f7aa3.pdf

Serial\0017\m1\us\us-regional.xml_09ad3501800f7aa4.xml

Serial\0017\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7aa5.pdf

Serial\0017\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7aa6.xml

Serial\0017\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7aa7.dtd

Serial\0017\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7aa8.dtd

Serial\0017\util\dtd\us-regional-v2-01.dtd_09ad3501800f7aa9.dtd

Serial\0017\util\style\ectd-2-0.xsl_09ad3501800f7aaa.xsl

Serial\0017\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7aab.xsl

Serial\0017\util\style\us-regional.xsl_09ad3501800f7aac.xsl

Serial\0017\util\style\valid-values.xml_09ad3501800f7aad.xml

Serial\0018\index.xml_09ad3501800f7abe.xml

Serial\0018\index-md5.txt_09ad3501800f7abd.txt

Serial\0018\m1\us\1571.pdf_09ad3501800f7ab0.pdf

Serial\0018\m1\us\cover-letter.pdf_09ad3501800f7ab1.pdf

Serial\0018\m1\us\investigator-letter.pdf_09ad3501800f7ab2.pdf

Serial\0018\m1\us\us-regional.xml_09ad3501800f7ab3.xml

Serial\0018\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7ab4.pdf

Serial\0018\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7ab5.xml

Serial\0018\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7ab6.dtd

Serial\0018\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7ab7.dtd

Serial\0018\util\dtd\us-regional-v2-01.dtd_09ad3501800f7ab8.dtd

Serial\0018\util\style\ectd-2-0.xsl_09ad3501800f7ab9.xsl

Serial\0018\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7aba.xsl

Serial\0018\util\style\us-regional.xsl_09ad3501800f7abb.xsl

Serial\0018\util\style\valid-values.xml_09ad3501800f7abc.xml

Serial\0019\index.xml_09ad3501800f7acd.xml

     

     

    

 

 

Serial\0019\index-md5.txt_09ad3501800f7acc.txt

Serial\0019\m1\us\1571.pdf_09ad3501800f7abf.pdf

Serial\0019\m1\us\cover-letter.pdf_09ad3501800f7ac0.pdf

Serial\0019\m1\us\inv-letter.pdf_09ad3501800f7ac1.pdf

Serial\0019\m1\us\us-regional.xml_09ad3501800f7ac2.xml

Serial\0019\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7ac3.pdf

Serial\0019\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7ac4.xml

Serial\0019\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7ac5.dtd

Serial\0019\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7ac6.dtd

Serial\0019\util\dtd\us-regional-v2-01.dtd_09ad3501800f7ac7.dtd

Serial\0019\util\style\ectd-2-0.xsl_09ad3501800f7ac8.xsl

Serial\0019\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7ac9.xsl

Serial\0019\util\style\us-regional.xsl_09ad3501800f7aca.xsl

Serial\0019\util\style\valid-values.xml_09ad3501800f7acb.xml

Serial\0020\index.xml_09ad3501800f7b8a.xml

Serial\0020\index-md5.txt_09ad3501800f7b89.txt

Serial\0020\m1\us\1571.pdf_09ad3501800f7b7c.pdf

Serial\0020\m1\us\cover-letter.pdf_09ad3501800f7b7d.pdf

Serial\0020\m1\us\inv-ltr.pdf_09ad3501800f7b7e.pdf

Serial\0020\m1\us\us-regional.xml_09ad3501800f7b7f.xml

Serial\0020\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7b80.pdf

Serial\0020\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7b81.xml

Serial\0020\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7b82.dtd

Serial\0020\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7b83.dtd

Serial\0020\util\dtd\us-regional-v2-01.dtd_09ad3501800f7b84.dtd

Serial\0020\util\style\ectd-2-0.xsl_09ad3501800f7b85.xsl

Serial\0020\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7b86.xsl

Serial\0020\util\style\us-regional.xsl_09ad3501800f7b87.xsl

Serial\0020\util\style\valid-values.xml_09ad3501800f7b88.xml

Serial\0021\index.xml_09ad3501800f7ba1.xml

Serial\0021\index-md5.txt_09ad3501800f7ba0.txt

Serial\0021\m1\us\1-13-10-foreign-market-hist.pdf_09ad3501800f7b8c.pdf

Serial\0021\m1\us\1-13-1-sum-nonclin-stud.pdf_09ad3501800f7b8b.pdf

Serial\0021\m1\us\1-13-3-sum-saf-info.pdf_09ad3501800f7b8d.pdf

Serial\0021\m1\us\1-13-4-sum-label-chang.pdf_09ad3501800f7b8e.pdf

Serial\0021\m1\us\1-13-5-sum-man-changes.pdf_09ad3501800f7b8f.pdf

Serial\0021\m1\us\1-13-7-sum-other-sig-new-info.pdf_09ad3501800f7b90.pdf

Serial\0021\m1\us\1-13-8-ind-study-info.pdf_09ad3501800f7b91.pdf

Serial\0021\m1\us\1-13-9-gen-inv-plan.pdf_09ad3501800f7b92.pdf

Serial\0021\m1\us\1571.pdf_09ad3501800f7b93.pdf

Serial\0021\m1\us\3674.pdf_09ad3501800f7b94.pdf

Serial\0021\m1\us\cover-letter.pdf_09ad3501800f7b95.pdf

Serial\0021\m1\us\ib.pdf_09ad3501800f7b97.pdf

Serial\0021\m1\us\ib-sum-changes.pdf_09ad3501800f7b96.pdf

Serial\0021\m1\us\us-regional.xml_09ad3501800f7b98.xml

Serial\0021\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7b99.dtd

Serial\0021\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7b9a.dtd

Serial\0021\util\dtd\us-regional-v2-01.dtd_09ad3501800f7b9b.dtd

Serial\0021\util\style\ectd-2-0.xsl_09ad3501800f7b9c.xsl

Serial\0021\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7b9d.xsl

Serial\0021\util\style\us-regional.xsl_09ad3501800f7b9e.xsl

Serial\0021\util\style\valid-values.xml_09ad3501800f7b9f.xml

 

     

     

    

  

Serial\0022\index.xml_09ad3501800f7b5d.xml

Serial\0022\index-md5.txt_09ad3501800f7b5c.txt

Serial\0022\m1\us\1571.pdf_09ad3501800f7b1c.pdf

Serial\0022\m1\us\3674.pdf_09ad3501800f7b1d.pdf

Serial\0022\m1\us\cover-letter.pdf_09ad3501800f7b1e.pdf

Serial\0022\m1\us\us-regional.xml_09ad3501800f7b1f.xml

Serial\0022\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\osi-027-101-protocol-v6.pdf_09ad3501800f7b20.pdf

Serial\0022\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7b21.xml

Serial\0022\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7b22.dtd

Serial\0022\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7b23.dtd

Serial\0022\util\dtd\us-regional-v2-01.dtd_09ad3501800f7b24.dtd

Serial\0022\util\style\ectd-2-0.xsl_09ad3501800f7b58.xsl

Serial\0022\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7b59.xsl

Serial\0022\util\style\us-regional.xsl_09ad3501800f7b5a.xsl

Serial\0022\util\style\valid-values.xml_09ad3501800f7b5b.xml

Serial\0023\index.xml_09ad3501800f7b6c.xml

Serial\0023\index-md5.txt_09ad3501800f7b6b.txt

Serial\0023\m1\us\1571.pdf_09ad3501800f7b5e.pdf

Serial\0023\m1\us\cover-letter.pdf_09ad3501800f7b5f.pdf

Serial\0023\m1\us\inv-let.pdf_09ad3501800f7b60.pdf

Serial\0023\m1\us\us-regional.xml_09ad3501800f7b61.xml

Serial\0023\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7b62.pdf

Serial\0023\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7b63.xml

Serial\0023\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7b64.dtd

Serial\0023\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7b65.dtd

Serial\0023\util\dtd\us-regional-v2-01.dtd_09ad3501800f7b66.dtd

Serial\0023\util\style\ectd-2-0.xsl_09ad3501800f7b67.xsl

Serial\0023\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7b68.xsl

Serial\0023\util\style\us-regional.xsl_09ad3501800f7b69.xsl

Serial\0023\util\style\valid-values.xml_09ad3501800f7b6a.xml

Serial\0024\index.xml_09ad3501800f7b7b.xml

Serial\0024\index-md5.txt_09ad3501800f7b7a.txt

Serial\0024\m1\us\1571.pdf_09ad3501800f7b6d.pdf

Serial\0024\m1\us\cover-letter.pdf_09ad3501800f7b6e.pdf

Serial\0024\m1\us\inv-let.pdf_09ad3501800f7b6f.pdf

Serial\0024\m1\us\us-regional.xml_09ad3501800f7b70.xml

Serial\0024\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7b71.pdf

Serial\0024\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7b72.xml

Serial\0024\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7b73.dtd

Serial\0024\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7b74.dtd

Serial\0024\util\dtd\us-regional-v2-01.dtd_09ad3501800f7b75.dtd

Serial\0024\util\style\ectd-2-0.xsl_09ad3501800f7b76.xsl

Serial\0024\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7b77.xsl

Serial\0024\util\style\us-regional.xsl_09ad3501800f7b78.xsl

Serial\0024\util\style\valid-values.xml_09ad3501800f7b79.xml

Serial\0025\index.xml_09ad3501800f7c04.xml

Serial\0025\index-md5.txt_09ad3501800f7c03.txt

Serial\0025\m1\us\1571.pdf_09ad3501800f7bf8.pdf

Serial\0025\m1\us\cover-letter.pdf_09ad3501800f7bf9.pdf

Serial\0025\m1\us\ib-gfi.pdf_09ad3501800f7bfa.pdf

 

     

     

    

  

Serial\0025\m1\us\us-regional.xml_09ad3501800f7bfb.xml

Serial\0025\util\dtd\ich-ectd-3-2.dtd_09ad3501800f7bfc.dtd

Serial\0025\util\dtd\ich-stf-v2-2.dtd_09ad3501800f7bfd.dtd

Serial\0025\util\dtd\us-regional-v2-01.dtd_09ad3501800f7bfe.dtd

Serial\0025\util\style\ectd-2-0.xsl_09ad3501800f7bff.xsl

Serial\0025\util\style\ich-stf-stylesheet-2-2.xsl_09ad3501800f7c00.xsl

Serial\0025\util\style\us-regional.xsl_09ad3501800f7c01.xsl

Serial\0025\util\style\valid-values.xml_09ad3501800f7c02.xml

Serial\0026\index.xml_09ad3501800f7bd8.xml

Serial\0026\index-md5.txt_09ad3501800f7bd7.txt

Serial\0026\m1\us\1571.pdf_09ad3501800f7ba2.pdf

Serial\0026\m1\us\cover-letter.pdf_09ad3501800f7ba3.pdf

Serial\0026\m1\us\inv-letter.pdf_09ad3501800f7ba4.pdf

Serial\0026\m1\us\us-regional.xml_09ad3501800f7ba5.xml

Serial\0026\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\medwatch.pdf_09ad3501800f7ba6.pdf

Serial\0026\m5\53-clin-stud-rep\533-rep-human-pk-stud\5332-patient-pk-init-tol-stud-rep\osi-027-101\stf-osi-027-101.xml_09ad3501800f7ba7.xml

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2009003197 - 15-day report 02-Nov-09\Cover Letter MHRA SUSAR
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2009003635CIOMS.pdf_09ad350180153c4e.pdf

Acknowledgment_7th January 08.pdf_09ad350180153cc1.pdf

Annex 2 027-101 FAMHP Sub Amend Serial 003.doc_09ad350180153c86.doc

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annex-1.xml_09ad350180153c77.xml

annex-1.xml_09ad350180153c7b.xml

annex-1.xml_09ad350180153c8b.xml

 

     

     

    

  

annex-1.xml_09ad350180153d16.xml

annex-1.xml_09ad350180153d22.xml

annex-1.xml_09ad350180153d33.xml

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annex-2.pdf_09ad350180153d4b.pdf

ANNEX2~1.DOC_09ad350180153c67.doc

ANNEX2~1.DOC_09ad350180153c6e.doc

Application form signed PDF v1.0 31 Dec 07.pdf_09ad350180153c9e.pdf

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BE\OSI-027-101\20130118\qp-declaration.pdf_09ad3501801befd7.pdf

 

     

     

    

  

BE\OSI-027-101\20130319\annex-3.pdf_09ad3501801d780c.pdf

BE\OSI-027-101\20130319\covering-letter.pdf_09ad3501801d780d.pdf

BE\OSI-027-101\20130319\investigators-letter.pdf_09ad3501801d780e.pdf

Belgium CTA Tabs.doc_09ad350180153c6f.doc

Belgium CTA Tabs.doc_09ad350180153c87.doc

Belgium FAHMP 027-101 approval letter IMPd update Serial 004
23 Dec 09.pdf_09ad350180153b80.pdf

Clinical Information for MHRA discussion 05-Feb-09\MHALTR~1.PDF_09ad350180153cb1.pdf

Cover Letter 09-Apr-08.pdf_09ad350180153b7e.pdf

Cover letter 31 Dec 2007.pdf_09ad350180153ca0.pdf

Cover Letter FAMHP SUSAR 027-101 02-Nov-09.pdf_09ad350180153c46.pdf

Cover Letter FAMHP SUSAR 027-101 27-Oct-09.pdf_09ad350180153c41.pdf

Cover letter FAMHP SUSAR 26-Aug-09.doc_09ad350180153c5d.doc

Cover letter FAMHP SUSAR 26-Aug-09.pdf_09ad350180153c5e.pdf

Cover letter FAMHP SUSAR 27-Oct-09.doc_09ad350180153c42.doc

Cover Letter FAMHP SUSAR follow-up 13-Oct-09.doc_09ad350180153c60.doc

Cover Letter FAMHP SUSAR follow-up OSI-027-101 13-Oct-09.pdf_09ad350180153c61.pdf

Cover letter FAMHP SUSAR OSI-027-101 02-Nov-09.doc_09ad350180153c47.doc

Cover letter FAMHP SUSAR OSI-027-101 03-Dec-09.doc_09ad350180153c4b.doc

Cover letter FAMHP SUSAR OSI-027-101 14-Dec-09.doc_09ad350180153c4f.doc

COVERL~1.DOC_09ad350180153c68.doc

COVERL~1.DOC_09ad350180153c70.doc

cover-letter.pdf_09ad350180153c6c.pdf

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cover-letter.pdf_09ad350180153d36.pdf

cover-letter.pdf_09ad350180153d40.pdf

cover-letter.pdf_09ad350180153d4c.pdf

CTA Cover Label.doc_09ad350180153c88.doc

CTA Cover Label.doc_09ad350180153d3c.doc

ctatoc.pdf_09ad350180153ca1.pdf

Drug_Product_Shelf_Life_4 Mar 08.pdf_09ad350180153d55.pdf

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EudraCT receipt.pdf_09ad350180153ca2.pdf

Expedited Report (preclinical) 04-Sep-08\MHRA Expedited Safety
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Expedited Report (preclinical) 04-Sep-08\MHRA expedited safety
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FAMHP approval of initial CTA.pdf_09ad350180153b82.pdf

FAMHP approval of Subs. Amend Serial 001.doc_09ad350180153b83.doc

FAMHP email regarding amendment payment 11-Sep-08.pdf_09ad350180153b84.pdf

FAMHP Expedited Safety Report 04-Sep-08.doc_09ad350180153c52.doc

FAMHP expedited safety report 04-Sep-08.pdf_09ad350180153c53.pdf

FAMHPC~1.DOC_09ad350180153c89.doc

Final Word docs\Annex_2_001_4 Mar 08.doc_09ad350180153d51.doc

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FINALW~1\027-101 CTA Letter of Authorisation.doc_09ad350180153c66.doc

FlySheet_ASP7486_EU_SUBM.xls_09ad35018010c6c8.xls

 

     

     

    

  

gp-letter-changes-accepted.pdf_09ad350180153d25.pdf

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letter-of-authorization.pdf_09ad350180153c82.pdf

letter-of-authorization.pdf_09ad350180153d19.pdf

letter-of-authorization.pdf_09ad350180153d37.pdf

Ltr FAMHP SUSAR 16-Sep-08.pdf_09ad350180153c55.pdf

Ltr FAMHP SUSAR 17-Sep-08.doc_09ad350180153c56.doc

Ltr FAMHP SUSAR 21-Apr-09.doc_09ad350180153c59.doc

Ltr MHRA_Amendment 001_ 4 Mar 08.pdf_09ad350180153d56.pdf

MHA Ltr- 14.11.08-Notice of Acceptance of Amendment _Serial
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MHRA 07 July 09_Acknowledgement of Amend - Serial No.6.pdf_09ad350180153cc6.pdf

MHRA 07-Apr-08 approval of shelf life extension.pdf_09ad350180153cc7.pdf

MHRA 07-Aug-08 acknowledgment Serial 003.pdf_09ad350180153cc8.pdf

MHRA 07-Mar-08 acknowledgement of substantial amendment 001.pdf_09ad350180153cc9.pdf

MHRA 12-Mar-08 response to shelf life plan.pdf_09ad350180153cca.pdf

MHRA 17-Nov-08 approval of Sub Amend Serial 004.pdf_09ad350180153ccb.pdf

MHRA 24-April- 09 027 SUSAR acknowledgement 2009001108.pdf_09ad350180153ccc.pdf

MHRA 26-Mar-08 acknowledgement of substantial amendment 002.pdf_09ad350180153ccd.pdf

MHRA 28-Feb-08 acceptance of protocol amendment 1.pdf_09ad350180153cce.pdf

MHRA 29.06.09_Non substantial Amendment Notification - Expiration
period extension.pdf

MHRA 29.06.09_Non substantial Amendment Notification - Expiration
period extension.pdf_09ad350180153c3f.pdf

MHRA acknowledgement of 027 substantial amendment Serial 004.pdf_09ad350180153cd0.pdf

MHRA Letter 13.02.08.pdf_09ad350180153d29.pdf

MHRA Ltr - 07.08.08-Notification of Amend.pdf_09ad350180153cd1.pdf

MHRA Ltr_03.09.09_SUSAR Acknow.pdf_09ad350180153cd2.pdf

MHRA Ltr_16.12.09_SUSAR Acknow.pdf_09ad350180153cd3.pdf

MHRA Ltr_29.10.09_SUSAR Acknow.pdf_09ad350180153cd4.pdf

MHRA SA acceptance 5-01-2010 Serial 007.pdf_09ad350180153cd5.pdf

MHRA_005_19.06.09.pdf_09ad350180153cd6.pdf

MHRA_SUSAR Acknow_03.11.09.pdf_09ad350180153cd7.pdf

MHRACO~1.DOC_09ad350180153d3d.doc

MHRACO~1.DOC_09ad350180153d44.doc

OSI risk assessment of Pii\Attachment 1.pdf_09ad350180153cb4.pdf

OSI risk assessment of Pii\Attachment 2 - sent by e-mail.doc_09ad350180153cb5.doc

OSI risk assessment of Pii\Attachment 3.pdf_09ad350180153cb6.pdf

OSI risk assessment of Pii\Attachment 4.pdf_09ad350180153cb7.pdf

OSI risk assessment of Pii\risk assessment.pdf_09ad350180153cb8.pdf

OSI-027 2008002289 CIOMS.pdf_09ad350180153c63.pdf

OSI-027 IMPD DP Final 20-Dec-07.doc_09ad350180153d57.doc

OSI-027 IMPD DP Version 1.1 16-Jun-09.pdf_09ad350180153d5d.pdf

 

     

     

    

 

OSI-027 IMPD DP Version 1.1 Final 15-Jun-09.doc_09ad350180153d5e.doc

OSI-027 IMPD DS Final 17-Dec-07.doc_09ad350180153d58.doc

OSI-027 IMPD Nonclinical Final 20-Dec-07.doc_09ad350180153d59.doc

OSI-027 Investigator Letter 2009001108.pdf_09ad350180153c5a.pdf

OSI-027 Investigator Letter 2009002454.pdf_09ad350180153c5f.pdf

OSI-027 Investigator Letter CHF 2 Oct 2009_SMc.doc_09ad350180153c64.doc

OSI-027 Investigator Letter LVEF 12Sep_FINAL.pdf_09ad350180153c57.pdf

OSI-027 SUSAR cover letter BE 22-Apr-09.pdf_09ad350180153c5b.pdf

OSI-027-101 SUSAR Cover Letter FAMHP 03-Dec-09.pdf_09ad350180153c4d.pdf

OSI-027-101 SUSAR Cover Letter FAMHP 14-Dec-09.pdf_09ad350180153c51.pdf

osi-027-101-impd.pdf_09ad350180153c8e.pdf

osi-027-101-impd.pdf_09ad350180153d4d.pdf

osi-027-101-protocol.pdf_09ad350180153c91.pdf

osi-027-101-protocol-summary-v4.pdf_09ad350180153c8f.pdf

osi-027-101-protocol-summary-v4.pdf_09ad350180153d4e.pdf

osi-027-101-protocol-summary-v5.pdf_09ad350180153c90.pdf

osi-027-101-protocol-summary-v5.pdf_09ad350180153d4f.pdf

osi-027-101-protocol-v5.pdf_09ad350180153d50.pdf

osi-027-impd-dp.pdf_09ad350180153c83.pdf

osi-027-impd-dp.pdf_09ad350180153d38.pdf

PMayne EGodfrey conversation 14-Oct-08.pdf_09ad350180153cd8.pdf

Prot OSI-027-101 V2 02-08-08.pdf_09ad350180153d2a.pdf

Prot OSI-027-101 V2 Am Sum 02-08-08.pdf_09ad350180153d2b.pdf

qp-declaration.pdf_09ad350180153c84.pdf

qp-declaration.pdf_09ad350180153d39.pdf

Rejection of initial CTA\027-101 CTA Letter of Authorisation.doc_09ad350180153cba.doc

Rejection of initial CTA\OSI-027 CTA Letter of Authorization.pdf_09ad350180153cbc.pdf

Response to non-acceptance\12-Feb-08 response to non-acceptance.doc_09ad350180153cbd.doc

Response to non-acceptance\MHRA Letter 13.02.08.pdf_09ad350180153cbe.pdf

Response to non-acceptance\MHRA questions 04-Feb-08.pdf_09ad350180153cbf.pdf

Response to non-acceptance\Paragraph to be added to MHRA cover
letter.doc_09ad350180153cc0.doc

Section J checklist.pdf_09ad350180153ca3.pdf

SUPPLE~1\Batch release authorisation.pdf_09ad350180153c92.pdf

SUPPLE~1\IMPD Drug Product v1.0.pdf_09ad350180153c93.pdf

SUPPLE~1\IMPD Drug Substance v1.0.pdf_09ad350180153c94.pdf

SUPPLE~1\IMPD Non Clinical v1.0.pdf_09ad350180153c95.pdf

SUPPLE~1\Importers authorisation.pdf_09ad350180153c96.pdf

SUPPLE~1\Investigator Brochure 1st Edition.pdf_09ad350180153c97.pdf

SUPPLE~1\Labels v1.0.pdf_09ad350180153c98.pdf

SUPPLE~1\Protocol v1.0 14 Dec 07.pdf_09ad350180153c99.pdf

SUPPLE~1\QP declaration.pdf_09ad350180153c9a.pdf

SUPPLE~1\Summary of Protocol V1.0 14 Dec 07.pdf_09ad350180153c9b.pdf

SUPPLE~1\TSE Certificate Capsugel.pdf_09ad350180153c9c.pdf

SUPPLE~1\TSE Certificate OSI-027.pdf_09ad350180153c9d.pdf

SUSAR 15-day report 16-Sep-08\2008002289_CIOMS.pdf_09ad350180153cf4.pdf

SUSAR 15-day report 16-Sep-08\Ltr MHRA SUSAR 16-Sep-08.pdf_09ad350180153cf5.pdf

SUSAR 15-day report 16-Sep-08\Ltr MHRA SUSAR 17-Sep-08.doc_09ad350180153cf6.doc

SUSAR 15-day report 16-Sep-08\OSI-027 Investigator Letter LVEF
12Sep_FINAL.pdf_09ad350180153cf7.pdf

SUSAR 15-day report 22-Apr-09\2009001108 CIOMS I.pdf_09ad350180153cf8.pdf

SUSAR 15-day report 22-Apr-09\Ltr MHRA SUSAR 22-Apr-09.doc_09ad350180153cf9.doc

SUSAR 15-day report 22-Apr-09\OSI-027 Investigator Letter 2009001108.pdf_09ad350180153cfa.pdf

SUSAR 15-day report 22-Apr-09\OSI-027 SUSAR cover letter 22-Apr-09.pdf_09ad350180153cfb.pdf

SUSAR 15-day report 26-Aug-09\2009002454 CIOMS.pdf_09ad350180153cfc.pdf

SUSAR 15-day report 26-Aug-09\Cover Letter MHRA SUSAR 26-Aug-09.doc_09ad350180153cfd.doc

SUSAR 15-day report 26-Aug-09\Cover letter MHRA SUSAR 26-Aug-09.pdf_09ad350180153cfe.pdf

SUSAR 15-day report 26-Aug-09\OSI-027 Investigator Letter 2009002454.pdf_09ad350180153cff.pdf

 

     

     

    

 

 

SUSARF~1\Cover Letter MHRA SUSAR follow-up 13-Oct-09.doc_09ad350180153d00.doc

SUSARF~1\Cover Letter MHRA SUSAR follow-up 13-Oct-09.pdf_09ad350180153d04.pdf

SUSARF~1\Fax cover sheet SUSAR follow-up 13-Oct-09.pdf_09ad350180153d05.pdf

SUSARF~1\OSI Fax Cover SUSAR Follow-up 13-Oct-09.doc_09ad350180153d07.doc

SUSARF~1\OSI-027 2008002289 CIOMS.pdf_09ad350180153d08.pdf

SUSARF~1\OSI-027 Investigator Letter CHF 2 Oct 2009_SMc.doc_09ad350180153d09.doc

Telephone contact with MHRA 05-Feb-09.doc_09ad350180153cd9.doc

Telephone contact with MHRA 05-Feb-09.pdf_09ad350180153cda.pdf

Telephone contact with MHRA 06-Feb-09.doc_09ad350180153cdb.doc

Telephone contact with MHRA 06-Feb-09.pdf_09ad350180153cdc.pdf

Telephone contact with MHRA 25-Nov-08.doc_09ad350180153cdd.doc

Telephone contact with MHRA 25-Nov-08.pdf_09ad350180153cde.pdf

Telephone contact with MHRA 29-Jan-09.doc_09ad350180153cdf.doc

Telephone contact with MHRA 29-Jan-09.pdf_09ad350180153ce0.pdf

UK\Correspondence\20130123-MHRA-ack.pdf_09ad3501801cb3c0.pdf

UK\Correspondence\20130225-MHRA-non-accept.pdf_09ad3501801cdf56.pdf

UK\Correspondence\FlySheet_ASP7486_EU_CORRES.xls_09ad35018010c6cf.xls

UK\OSI-027-101\20080227.pdf_09ad350180125e4b.pdf

UK\OSI-027-101\20080409.pdf_09ad350180125e4c.pdf

UK\OSI-027-101\20080730.pdf_09ad350180125e4d.pdf

UK\OSI-027-101\20110516\annex-1.pdf_09ad35018010c6c9.pdf

UK\OSI-027-101\20110516\annex-1.xml_09ad35018010c6ca.xml

UK\OSI-027-101\20110516\annex-2.pdf_09ad35018010c6cb.pdf

UK\OSI-027-101\20110516\cover-letter.pdf_09ad35018010c6cc.pdf

UK\OSI-027-101\20110516\legal-representative-authorization.pdf_09ad35018010c6cd.pdf

UK\OSI-027-101\20110516\sponsor-change.pdf_09ad35018010c6ce.pdf

UK\OSI-027-101\20110621\1-2-covering-letter.pdf_09ad350180113e18.pdf

UK\OSI-027-101\20110621\1-3-application-form-annex-1.pdf_09ad350180113e19.pdf

UK\OSI-027-101\20110621\1-3-application-form-annex-1.xml_09ad350180113e1a.xml

UK\OSI-027-101\20110621\1-3-application-form-annex-2.pdf_09ad350180113e8f.pdf

UK\OSI-027-101\20110621\4-6-1-manufacturers-authorization.pdf_09ad350180113e90.pdf

UK\OSI-027-101\20110621\4-7-1-qp-declaration.pdf_09ad350180113e91.pdf

UK\OSI-027-101\20130118\1-2-covering-letter.pdf_09ad3501801bf004.pdf

UK\OSI-027-101\20130118\1-3-annex-2.pdf_09ad3501801bf005.pdf

UK\OSI-027-101\20130118\1-3-application-form.pdf_09ad3501801bf006.pdf

UK\OSI-027-101\20130118\1-3-application-form.xml_09ad3501801bf007.xml

UK\OSI-027-101\20130118\3-1-protocol-101-amend8.pdf_09ad3501801bf008.pdf

UK\OSI-027-101\20130118\3-1-protocol-7486-cl-0101-am9.pdf_09ad3501801bf009.pdf

UK\OSI-027-101\20130118\3-1-protocol-7486-cl-0101-clp-12-reissue-en-v11-02.pdf_09ad3501801bf00a.pdf

UK\OSI-027-101\20130118\3-1-protocol-7486-cl-0101-clp-en-am10-sam10-12.pdf_09ad3501801bf00b.pdf

UK\OSI-027-101\20130118\4-1-investigators-brochure.pdf_09ad3501801bf00c.pdf

UK\OSI-027-101\20130118\4-1-investigators-brochure-soc.pdf_09ad3501801bf00d.pdf

UK\OSI-027-101\20130118\4-6-1-manufacturers-authorisation.pdf_09ad3501801bf00e.pdf

UK\OSI-027-101\20130118\4-7-1-qp-declaration.pdf_09ad3501801bf00f.pdf

UK\OSI-027-101\20130118\impd\06-1-table-of-content.pdf_09ad3501801beffa.pdf

UK\OSI-027-101\20130118\impd\06-2-2-non-clinical.pdf_09ad3501801beffb.pdf

UK\OSI-027-101\20130118\impd\06-2-3-clinical.pdf_09ad3501801beffc.pdf

UK\OSI-027-101\20130118\impd\06-2-4-overall-risk-benefit-assessment.pdf_09ad3501801beffd.pdf

UK\OSI-027-101\20130118\impd\2-1-a-appendices.pdf_09ad3501801beffe.pdf

UK\OSI-027-101\20130118\impd\2-1-p-drug-product-cap.pdf_09ad3501801befff.pdf

UK\OSI-027-101\20130118\impd\2-1-p-drug-product-tab.pdf_09ad3501801bf000.pdf

UK\OSI-027-101\20130118\impd\2-1-s-drug-substance.pdf_09ad3501801bf001.pdf

UK\OSI-027-101\20130118\impd\OSI-027-IMPD-soc.pdf_09ad3501801bf002.pdf

UK\OSI-027-101\20130118\impd\Thumbs.db_09ad3501801bf003

UK\OSI-027-101\20130118\m1-3-1-label.pdf_09ad3501801bf010.pdf

UK\OSI-027-101\20130319\1-2-covering-letter.pdf_09ad3501801d7811.pdf

 

     

     

    

 

UK\OSI-027-101\20130319\annex-3.pdf_09ad3501801d780f.pdf

UK\OSI-027-101\20130319\investigators-letter.pdf_09ad3501801d7810.pdf

UK\OSI-027-101\Historical Submissions\OSI Archive - IMPD\Version
1.0\IMPD Drug Product v1.0.pdf_09ad350180153d5a.pdf

UK\OSI-027-101\Historical Submissions\OSI Archive - IMPD\Version
1.0\IMPD Drug Substance v1.0.pdf_09ad350180153d5b.pdf

UK\OSI-027-101\Historical Submissions\OSI Archive - IMPD\Version
1.0\IMPD Non Clinical v1.0.pdf_09ad350180153d5c.pdf

UK\OSI-027-101\Historical Submissions\OSI Archive - IMPD\Version
2.0\OSI-027 IMPD Version 2.0 final.doc_09ad350180153d5f.doc

UK\OSI-027-101\Historical Submissions\OSI Archive - IMPD\Version
2.0\OSI-027 IMPD Version 2.0 final.pdf_09ad350180153d60.pdf

UK\OSI-027-101\Historical Submissions\OSI Archive - IMPD\Version
2.0\TSE Certificate Capsugel.pdf_09ad350180153d61.pdf

UK\OSI-027-101\Historical Submissions\OSI Archive - IMPD\Version
2.0\TSE Certificate OSI-027.pdf_09ad350180153d62.pdf

 

		6.	CMC

TM-121 (1.0), Determination of Residual Solvents in OSI-027RP
Drug Substance by GC-HS.pdf

TM-123 (2.0), Assay and Related Substances in OSI-027RP G1Capsules.
5mg and 20mg .pdf

TM-125 (2.0), HPLC Method for Identity, Assay, Impurities of
OSI-027RP Drug Substance.pdf

TM-132 (2.0), Assay and Related Substances in OSI-027RP Tablets
(5mg, 20mg 100mg).pdf

OSI-027RP Residual Solvents Qualification Plan.pdf

MQR-TM-128-CA.00 (OSIP692940) 08-Nov-2011.pdf

MVR-LC-074-CK.01 Validation Report_027RP Assay and Related Substances
..pdf

Final signature page from MQR-LC-075 (tromethamine).pdf

21901000 IPC10 OSI-027AA Reaction Completion OSIP700068 to OSI-027AA.PDF

Approval letter for OSI-027AA 21901000 ICP10 Conversion 700068
to 027AA.pdf

OSI-027RP Micronized Bulk Monograph, Revision 03 effective Dec
2012.pdf

F-2484-019B-30perpack-OSP07-0019-1-Add 091108.pdf

F-2484-021-30perpack-OSP07-0020-1- 091108.pdf

INV08-0166 Pii 6M 4075 lot 13802.001A.pdf

LIR 08-0166 for failing assay at 6M 40-75.pdf

Pages from OSI-027RP 20mg Caps Batch Record 13803 001.pdf

Pages from OSI-027RP 5mg Caps Batch Record 13802 001.pdf

Pages from Pages from OSI-027RP BLend BR 13801 001.pdf

Interim Comparability Report milled vs unmilled Interim.pdf

07-2-OSI-027RP 100mg tab OS2T100MG1701 (bottles) 06M 4075.pdf

07-4-OSI-027RP 100mg tab OS2T100MG1701 (blisters) 06M 4075.pdf

01_Analytical\01_Analytical Development Reports\01_Drug Product\Notebook
VR1943 Final Assay _ REl Sub Report-.pdf

01_Analytical\01_Analytical Development Reports\01_Drug Product\VR
1944 Final Dissolution Validation Summary Report.pdf

01_Analytical\01_Analytical Development Reports\02_Drug Substance\AD12-013Rev1_Revised
AssayPurity Test Method for OSIP690520AA.pdf

01_Analytical\01_Analytical Development Reports\02_Drug Substance\MQR-TM454-CA.00
final.pdf

01_Analytical\01_Analytical Development Reports\02_Drug Substance\PR-07088
Specificity testing review.pdf

01_Analytical\01_Analytical Development Reports\02_Drug Substance\PR-07089
TM451 Res Solv Final Report.pdf

01_Analytical\01_Analytical Development Reports\02_Drug Substance\PR-07105
TM454 Validation Review.pdf

01_Analytical\01_Analytical Development Reports\02_Drug Substance\Specificity
development report TM454 OSi-027RP.pdf

01_Analytical\01_Analytical Development Reports\02_Drug Substance\TM454
Soln Stab Report 1108.00.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\1-1-OSI-027RP 5mg cap F-2484-019B 24M.pdf

 

     

     

    

 

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\1-1-OSI-027RP 5mg cap OSIC0050101 12M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\1-2-OSI-027RP 5mg cap F-2484-019B 6M acc.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\1-2-OSI-027RP 5mg cap OSIC0050101 06M acc.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\2-1-OSI-027RP 20mg cap F-2484-021 24M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\2-1-OSI-027RP 20mg cap OSIC0200101 12M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\2-2-OSI-027RP 20mg cap F-2484-021 6M acc.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\2-2-OSI-027RP 20mg cap OSIC0200101 06M acc.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\3-1-OSI-027RP 5mg cap 13802.001A 24M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\3-1-OSI-027RP 5mg cap C1639A001 12M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\3-2-OSI-027RP 5mg cap 13802.001A 15M int.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\3-2-OSI-027RP 5mg cap C1639A001 06M acc.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\3-3-OSI-027RP 5mg cap 13802.001A 6M acc retest.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\4-1-OSI-027RP 20mg cap 13803.001A 24M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\4-1-OSI-027RP 20mg cap, C1640A001 12M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\4-2-OSI-027RP 20mg cap 13803.001A 15M int.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\4-2-OSI-027RP 20mg cap, C1640A001 06M acc.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\4-3-OSI-027RP 20mg cap 13803.001A 6M acc retest.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\5-OSI-027RP 5mg cap 13802.002A 18M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\6-OSI-027RP 20mg cap 13803.002A 18M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\01_Drug
Product\OSI-027RP Capsules Expiry 36M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\02_Drug
Substance\1-1-OSI-027RP CML-W-243-07-OS3-R001 24M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\02_Drug
Substance\1-2-OSI-027RP CML-W-243-07-OS3-R001 6M acc.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\02_Drug
Substance\2-OSI-027RP CML-W-076-08-OS4 36M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\02_Drug
Substance\5-1-OSI-027RP 09100041 00M.pdf

01_Analytical\01_Analytical Development Reports\03_Stability\02_Drug
Substance\OSI-027RP API Retest date ext to 36M.pdf

01_Analytical\02_Characterization\7585-12-5_elucidationreport_052412.pdf

01_Analytical\02_Characterization\dimers.pdf

01_Analytical\02_Characterization\Micron Tech XRPD report 2007-0547-CC.pdf

01_Analytical\02_Characterization\TGA of OSI-027RP lot 975-18-1.pdf

01_Analytical\03_Impurities\7585-12-5_elucidationreport_052412.pdf

01_Analytical\03_Impurities\AD12-014_Structure Elucidation of
Impurities in OSI-027RP_DP.pdf

 

     

     

    

  

01_Analytical\03_Impurities\AD13-001_Related Substances of Historical
Batches of OSI-027RP Drug Substances.pdf

01_Analytical\04_Methods\01_Contractor Methods\01_AMRI versions\21900000
IPC10 OSIP700068 Reactor Drying.pdf

01_Analytical\04_Methods\01_Contractor Methods\01_AMRI versions\TM.2565
V2.pdf

01_Analytical\04_Methods\01_Contractor Methods\01_AMRI versions\TM.2587
V1. Pd and Ir in OSI-027.pdf

01_Analytical\04_Methods\01_Contractor Methods\01_AMRI versions\TM.2632
V2. Chloride in OSI-027AA.pdf

01_Analytical\04_Methods\01_Contractor Methods\01_AMRI versions\TM.53
v3.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-114
(1.0), Appearance of Solid Substances.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-120
(1.0), OSIP166874 in OSIP758725AA (monomethyl ester).pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-122
(1.0), Karl Fischer Determination of Water in OSI-027RP Capsules.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-124
(3.0), Dissolution of OSI-027RP Capsules by HPLC.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-126
(1.0), HPLC Method for Determination of Tromethamine in OSI-027RP.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-127
(3.0), HPLC Method for Assay and Purity of OSIP699678.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-128
(3.0), HPLC Method for Assay and Purity of OSIP692940.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-129
(1.0), Microbial Limits Test for OSI-027RP Capsules.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-130
(1.0), Particle Size Analysis of OSI-027RP by Laser Diffraction.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-131
(1.0), IP Analysis of the OSI-027 Synthetic Intermediates by HPLC.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-133
(3.0), Dissolution of OSI-027RP Tablets by HPLC.pdf

01_Analytical\04_Methods\01_Contractor Methods\02_Astellas\TM-171
(1.0), Microbial Limits Test for OSI-027RP Tablets.pdf

01_Analytical\04_Methods\01_Contractor Methods\03_CML\TM449.pdf

01_Analytical\04_Methods\01_Contractor Methods\03_CML\TM451
residual solvents.pdf

01_Analytical\04_Methods\01_Contractor Methods\03_CML\TM453.03
final.pdf

01_Analytical\04_Methods\01_Contractor Methods\03_CML\TM454.04.pdf

01_Analytical\04_Methods\01_Contractor Methods\03_CML\TM455
tromethamine HPLC.pdf

01_Analytical\04_Methods\01_Contractor Methods\04_Micron Methods\501.855
Rev 2 PSD for OSI-027RP.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\CTMLP2208_R7_OSI-027RP
Cap_ASRS.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\CTMLP2209_R4_OSI-027RP
Cap_Disso.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\CTMLP2620_R6_OSI-027RP
Tab_ASRS.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\CTMLP2621_R5_OSI-027RP
Tab_Disso.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\CTMLP2633_R3_OSI-027RP
Cap_ASRS + sign off.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\CTMLP2634_R2_OSI-027RP
Cap_Disso + sign off.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\MD
Summary_OSI-027RP AS RS Tab_R0.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\MM-1126
R0 OSI-027 capsule micro method.pdf

01_Analytical\04_Methods\01_Contractor Methods\05_Patheon Methods\MM-1482
Micro Verification for 20, 50, 100 mg tablets .pdf

01_Analytical\04_Methods\01_Contractor Methods\06_Pii methods\Dissolution
TM07-0243.pdf

 

     

     

    

  

01_Analytical\04_Methods\01_Contractor Methods\06_Pii methods\HPLC
Assay TM 07-0256.01.pdf

01_Analytical\04_Methods\01_Contractor Methods\06_Pii methods\HPLC
Impurities TM07-0242.pdf

01_Analytical\04_Methods\01_Contractor Methods\06_Pii methods\KF
method TM07-0244.pdf

01_Analytical\04_Methods\01_Contractor Methods\06_Pii methods\Micro
method.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\OP 200-992
OVI.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\OP-013667
v 2.0.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\OP-014429
v 1.0.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\OP-018259
v 1.0.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\OP-018260
v 1.0.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\PROC-GIL-OP-012410
(4.0).pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\PROC-MAD-OP-013663
v3.0 In Process Reaction Monitoring.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\PROC-MADOP-013665
v3.0 HPLC Purity analysis of OSI-027RP.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\PROC-MAD-OP-018177
v.4.0.pdf

01_Analytical\04_Methods\01_Contractor Methods\07_SAFC\PROC-MAD-OP-018178
v.3.0.pdf

01_Analytical\04_Methods\01_Contractor Methods\08_SAFC-Sheboygan\PROC-SHE-OP-015036.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\01_LC-074
(OSI-027RP)\MQP-LC-074-AM.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\01_LC-074
(OSI-027RP)\MQR-LC-074-AM Data Tables.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\01_LC-074
(OSI-027RP)\MQR-LC-074-AM Primary Lab Source Data.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\01_LC-074
(OSI-027RP)\MQR-LC-074-AM Source Data 07-Oct-2010.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\01_LC-074
(OSI-027RP)\MQR-LC-074-AM.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\01_LC-074
(OSI-027RP)\OOS-2010-0095.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\02_LC-075
(Tromethamine)\Data Tables for MQR-LC-075-AM (Tromethamine).pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\02_LC-075
(Tromethamine)\MQP-LC-075-AM (Tromethamine).pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\02_LC-075
(Tromethamine)\MQR-LC-075-AM _Tromethamine_.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\02_LC-075
(Tromethamine)\Source Data for MQR-LC-075-AM (Tromethamine).pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\03_LC-076
(OSIP699678)\Data Table MQP-LC-076-AM.00.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\03_LC-076
(OSIP699678)\MQP-LC-076-AM.00 Source Data.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\03_LC-076
(OSIP699678)\MQP-LC-076-AM.00.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\03_LC-076
(OSIP699678)\MQR-LC-076-AM.00.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\04_LC-081
(OSIP692940)\Data Table MQP-LC-081.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\04_LC-081
(OSIP692940)\MQP-LC-081-AM.00.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\04_LC-081
(OSIP692940)\MQP-LC-081-AM.01 (OSIP692940) Data Package.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\04_LC-081
(OSIP692940)\MQP-LC-081-AM.01.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\04_LC-081
(OSIP692940)\MQR-LC-081-AM (OSIP692940).pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\05_Palladium\MQP
for Palladium and Iridum in OSI-027RP - TM.2587.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\05_Palladium\Pd
and Ir Qualification Data Package.pdf

 

     

     

    

  

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\05_Palladium\TM.2587
Pd and Ir in OSI-027 OSIapproval.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\06_TM.2565
Residual Solvents in API\OSI-027 OVI Qualification Data Tables.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\06_TM.2565
Residual Solvents in API\OSI-027 OVI Qualification Raw Data.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\06_TM.2565
Residual Solvents in API\TM.2565 v 1 OSI Approval form.pdf

01_Analytical\04_Methods\02_Method Qualifications\01_AMRI\ANC01197R.01
Particle SIze Development Report.pdf

01_Analytical\04_Methods\02_Method Qualifications\02_Bridgings\MBP-TM454-LC074.01.pdf

01_Analytical\04_Methods\02_Method Qualifications\02_Bridgings\MBR-TM454-LC074
source data.pdf

01_Analytical\04_Methods\02_Method Qualifications\02_Bridgings\MBR-TM454-LC074.00
30-Nov-2010.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\01_MQR-TM454-CA\MQR-TM454-CA.00
08-Nov-07.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\02_MTR-LC-074\Catalent
method change request.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\02_MTR-LC-074\MTP-LC-074-CA.00.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\02_MTR-LC-074\MTR-ATP-LC-074.CA
Receiving Lab (CA) data.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\02_MTR-LC-074\MTR-LC-074-CA
(OSI-027RP) 30-Nov-2010.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\02_MTR-LC-074\MTR-LC-074-CA
Primary Lab (CK) data.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\03_TM-127
= LC-076 (OSIP699678)\Deviation Record (OLR-M0132).pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\03_TM-127
= LC-076 (OSIP699678)\MQP-TM-127-CA.00.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\03_TM-127
= LC-076 (OSIP699678)\MQR-TM-127-CA (OSIP699678) 08-Nov-11.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\03_TM-127
= LC-076 (OSIP699678)\RPT-A-OLR-M0132 MQ(OSIP699678) Rev 1.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\03_TM-127
= LC-076 (OSIP699678)\RPT-A-OLR-M0132 MQ(OSIP699678).pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\04_TM-128
= LC-081 (OSIP692940)\MQP-TM-128-CA.00.pdf

01_Analytical\04_Methods\02_Method Qualifications\03_Catalent\04_TM-128
= LC-081 (OSIP692940)\RPT-A-OLR-M0132 MQ(OSIP692940).pdf

01_Analytical\04_Methods\02_Method Qualifications\04_Cedar Knolls\MVP-LC-074-CK.01.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\PR-07081
TM451 Res Solv Protocol.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\PR-07082
TM455 Tromethamine Validation Protocol.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\PR-07084
TM454 Specificity Protocol.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\PR-07087
TM455 Tromethamine Validation Report.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\PR-07088
TM454 Specificity testing review.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\PR-07089
TM451 Res Solv Final Report.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\PR-07105
TM454 Validation Review.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\re
sol signature.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\Specificity
development report TM454 OSi-027RP.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\Specificity
protocol signature.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\TM454
Soln Stab Report 1108.00.pdf

01_Analytical\04_Methods\02_Method Qualifications\05_CML\tromethamine
protocol signature.pdf

01_Analytical\04_Methods\02_Method Qualifications\06_Micron\OSI-027RP
PSD MV Report June 2012 color.pdf

01_Analytical\04_Methods\02_Method Qualifications\06_Micron\OSI-027RP
PSD MV Report June 2012.pdf

 

     

     

    

  

01_Analytical\04_Methods\02_Method Qualifications\06_Micron\PSD
Method validaiton protocol OSI-027RP.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\CTMLP2208_R6_OSI-027RP
Cap_ASRS.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\CTMLP2209_R4_OSI-027RP
Cap_Disso.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\Method
Validation (PH1) for the Determ of Diss Rel of OSI-027RP by HPLC.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\MM-1482
Micro Verification for 20,50 and 100 mg tablets .PDF

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\MM-1482
Micro Verification for 20,50 and 100 mg tablets Rev 1.PDF

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\MV
Data Summary_OSI-027RP Cap_ASRS_phase II_20120411.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\MV
Data Summary_OSI-027RP Cap_Diss_phase II_20120412.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-027
micro validation report 02 19 09.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-027
Tablet Micro Verification Report DN signature page.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AP-092-0212-R0
027 cap 20 mg Disso Phase 2 protocol.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AP-093-0212-R0
027 cap 20 mg AS-RS Phase 2 protocol .pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AP-095-0312-R0
OSI-027RP Tablets Assay Protocol.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AP-096-0312-R0
OSI-027RP Tablets Dissolution Protocol.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AR-056-0309-RO
MV report OSI-027RP Capsule Dissolution Phase 1.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AR-056-0309-RO
MV report OSI-027RP Capsule Dissolution.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AR-057-0309-R0
MV Report OSI-027RP Capsules AS-RS Phase 1.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AR-057-0309-R0
MV Report OSI-027RP Capsules AS-RS.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AR-111-0512-R0
027 cap 20 mg AS-RS Phase 2 report.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AR-112-0512-R0
027 cap 20 mg Disso Phase 2 report.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AR-113-0712-R0
MV Report OSI-027RP Tablets Assay and RS.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\OSI-AR-114-0712-R0
MV Report OSI-027RP Tablets Dissolution.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\Validation
summary table CTMLP2620_R6_OSI-027RP Tab_ASRS.pdf

01_Analytical\04_Methods\02_Method Qualifications\07_Patheon\Validation
summary table CTMLP2621_R5_OSI-027RP Tab_Disso.pdf

01_Analytical\04_Methods\02_Method Qualifications\08_Pii\NB
VR1943 Final Assay - Rel Sub RPT.pdf

01_Analytical\04_Methods\02_Method Qualifications\08_Pii\VR
1944 Final Dissolution Validation Summary Report .pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\01_LC-074
OSI-027RP Assay RS\MQP-LC-074.SM.00 13-Sep-2010.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\01_LC-074
OSI-027RP Assay RS\MQP-LC-074-SM source data.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\01_LC-074
OSI-027RP Assay RS\MQR-LC-074-AM Primary Lab Source Data.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\01_LC-074
OSI-027RP Assay RS\MQR-LC-074-SM.pdf

 

     

     

    

 

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\02_LC-075
Tromethamine\MQP-LC-075-SM (tromethamine).pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\02_LC-075
Tromethamine\MQR-LC-075 Tromethamine Source Data.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\02_LC-075
Tromethamine\MQR-LC-075-SM.00 (Tromethamine).pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\03_LC-076
OSIP699678\Data Tables MQR-LC-076-SM.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\03_LC-076
OSIP699678\MQP-LC-076-SM source data.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\03_LC-076
OSIP699678\MQP-LC-076-SM.00 (OSIP699678).pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\03_LC-076
OSIP699678\MQR-LC-076-SM.00 (OSIP699678).pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\04_LC-081
OSIP692940\Data Tables MQR-LC-081-SM.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\04_LC-081
OSIP692940\MQP-LC-081-SM (OSIP692940).pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\04_LC-081
OSIP692940\MQR-LC-081-SM source data.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\04_LC-081
OSIP692940\MQR-LC-081-SM.00 (OSIP692940).pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\05_SAFC
OP-018259 (OVI)\PROC-MAD-OP-018259 Res Sovent in OSI-027RP.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\05_SAFC
OP-018259 (OVI)\QR-416 (OSI Residual Solvents).pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\05_SAFC
OP-018259 (OVI)\QR-426 (Residual Solvents).pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\05_SAFC
OP-018259 (OVI)\QR-426 Res sol in 027RP OSI approval.pdf

01_Analytical\04_Methods\02_Method Qualifications\09_SAFC-Madison\SGS
micro validation for SAFC Jan 10.pdf

01_Analytical\04_Methods\02_Method Qualifications\SGS micro
validation for OSI-027RP.pdf

01_Analytical\04_Methods\03_Method Validation\OSI-027RP PSD
MV Report June 2012 color.pdf

01_Analytical\04_Methods\03_Method Validation\OSI-AR-113-0712-R0
MV Report OSI-027RP Tablets Assay and RS.pdf

01_Analytical\04_Methods\03_Method Validation\OSI-AR-114-0712-R0
MV Report OSI-027RP Tablets Dissolution.pdf

01_Analytical\04_Methods\04_OSI versions\ATP-GC-011 (1.0) OSIP166874
diacid in OSIP758725AA by GC analysis.pdf

01_Analytical\04_Methods\04_OSI versions\ATP-GC-012 (1.0).pdf

01_Analytical\04_Methods\04_OSI versions\ATP-GM-065 (1.0) Karl
Fischer Determination of Water in OSI-027RP Capsules.pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-059 (4.0) OSI-027RP
Capsules Assay + Impurities.pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-060 (1.0) Dissolution
of OSI-027RP Capsules by HPLC.pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-074(1.0) HPLC
Method for Identity, Assay, and Impurities of OSI-027RP Drug Substance.pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-075 (2.0).pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-076 (1.0).pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-080 (1.0).pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-081 (1.0).pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-082 (2.0) In-Process
Reaction Monitoring.pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-085(1.0).pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-086(1.0).pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-087(1.0).pdf

01_Analytical\04_Methods\04_OSI versions\ATP-LC-088(1.0).pdf

 

     

     

    

  

01_Analytical\04_Methods\04_OSI versions\ATP-MM-008 (1.0) Microbial
Limits Testing of OSI-027RP Capsules.pdf

01_Analytical\05_Microbiology\SGS micro validation for OSI-027RP.pdf

01_Analytical\06_Microscopy\OS7 Recrystallization Update_01122011_v2.pdf

01_Analytical\07_Palladium\01_7235-001\ADP ARD1210003.pdf

01_Analytical\07_Palladium\02_7235-008\ADP ARD0211001 Signed.pdf

01_Analytical\07_Palladium\02_7235-008\ADRF AD11-0043.pdf

01_Analytical\07_Palladium\03_Palladium - Intertek\OSI-027RP
Palladium Analysis of Ref Std.pdf

01_Analytical\07_Palladium\OSI-027RP ICP-MS vs ICP-OES with
attachments.pdf

01_Analytical\07_Palladium\OSI-027RP ICP-MS vs ICP-OES.pdf

01_Analytical\07_Palladium\Pages from CCH2-13-01 (FP-087 Pd
by ICP-OES).pdf

01_Analytical\07_Palladium\Pages from CMLW-076-08-OS4 Analytical
release data.pdf

01_Analytical\07_Palladium\Pages from CMLW-243-07-OS3 final
analytical data from BR.pdf

01_Analytical\07_Palladium\Pages from CMLW-469-08-OS3 Analytical
release data.pdf

01_Analytical\07_Palladium\Pages from QTI REPORT Ref std Aug-09.pdf

01_Analytical\07_Palladium\WCAS Pd Ir result.pdf

01_Analytical\08_Specifications\SPEC-117 (3.0) OSIP692940 (SAFC-Madison).pdf

01_Analytical\08_Specifications\SPEC-118 (2.0), OSIP692940,
AMRI India.pdf

01_Analytical\08_Specifications\SPEC-119 (3.0) OSIP699678 (SAFC-Madison).pdf

01_Analytical\08_Specifications\SPEC-120 (3.0) OSIP699678 (Escientia).pdf

01_Analytical\08_Specifications\SPEC-121 (3.0) OSIP699678 (AMRI-India).pdf

01_Analytical\08_Specifications\SPEC-122 (2.0), OSI-027RP, SAFC
Madison.pdf

01_Analytical\08_Specifications\SPEC-123 (2.0), OSI-027RP, AMRI-RSL.pdf

01_Analytical\08_Specifications\SPEC-124 (3.0) OSI-027 Capsules
5mg (Patheon).pdf

01_Analytical\08_Specifications\SPEC-125 (3.0) OSI-027 Capsules,
20 mg (Patheon).pdf

01_Analytical\08_Specifications\SPEC-126 (2.0), OSIP692940 (Quality).pdf

01_Analytical\08_Specifications\SPEC-127 (3.0) OSIP699678 (Quality).pdf

01_Analytical\08_Specifications\SPEC-128 (2.0), OSI-027RP (Quality).pdf

01_Analytical\08_Specifications\SPEC-129 (3.0) OSI-027 Capsules
5mg.pdf

01_Analytical\08_Specifications\SPEC-130 (3.0) OSI-027 Capsules
20 mg.pdf

01_Analytical\08_Specifications\SPEC-131 (3.0) Micronized OSI-027RP
(AMRI-RSL).pdf

01_Analytical\08_Specifications\SPEC-132 (3.0) Micronized OSI-027RP
(SAFC-Madison).pdf

01_Analytical\08_Specifications\SPEC-133 (3.0) Micronized OSI-027RP
(Micron).pdf

01_Analytical\08_Specifications\SPEC-134 (3.0) Micronized OSI-027RP
(Quality).pdf

01_Analytical\08_Specifications\SPEC-135 (1.0) OSIP692940 (SAFC-Sheboygan).pdf

01_Analytical\08_Specifications\SPEC-136 (1.0) OSIP699678 (SAFC-Sheboygan).pdf

01_Analytical\08_Specifications\SPEC-182 (4.0) OSI-027RP Tablets,
20mg (QSP).pdf

01_Analytical\08_Specifications\SPEC-183 (4.0) OSI-027RP Tablets,
50mg (QSP).pdf

01_Analytical\08_Specifications\SPEC-184 (4.0) OSI-027RP Tablets,
100mg (QSP).pdf

01_Analytical\08_Specifications\SPEC-185 (4.0) OSI-027RP Tablets,
20mg (Patheon).pdf

01_Analytical\08_Specifications\SPEC-186 (4.0) OSI-027RP Tablets,
50mg (Patheon).pdf

01_Analytical\08_Specifications\SPEC-187 (4.0) OSI-027RP Tablets,
100mg (Patheon).pdf

02_Batch Analysis Tables\01_OSI-027AA\01_09100040 AMRI 1st GMP
campiagn\analytical results.pdf

02_Batch Analysis Tables\01_OSI-027AA\01_09100040 AMRI 1st GMP
campiagn\OSI-027AA 09100040 yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\02_CMLW-011_08-OS3\bmr
yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\02_CMLW-011_08-OS3\CMLW-011-08-OS3
IPC data.pdf

02_Batch Analysis Tables\01_OSI-027AA\02_CMLW-011_08-OS3\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\02_CMLW-011_08-OS3\traceability2.pdf

02_Batch Analysis Tables\01_OSI-027AA\03_CMLW-223_07-OS2\bmr
yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\03_CMLW-223_07-OS2\CMLW-223-07-OS2Analytical.pdf

02_Batch Analysis Tables\01_OSI-027AA\03_CMLW-223_07-OS2\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\03_CMLW-223_07-OS2\pre-sample
weight page.pdf

02_Batch Analysis Tables\01_OSI-027AA\03_CMLW-223_07-OS2\traceability.pdf

02_Batch Analysis Tables\01_OSI-027AA\03_CMLW-223_07-OS2\traceability2.pdf

02_Batch Analysis Tables\01_OSI-027AA\04_CMLW-230_07-OS2\bmr
yield page.pdf

 

     

     

    

  

02_Batch Analysis Tables\01_OSI-027AA\04_CMLW-230_07-OS2\CMLW-230-07-OS2Analytical.pdf

02_Batch Analysis Tables\01_OSI-027AA\04_CMLW-230_07-OS2\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\05_CMLW-232_07-OS2\bmr
yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\05_CMLW-232_07-OS2\CMLW-232-07-OS2Analytical.pdf

02_Batch Analysis Tables\01_OSI-027AA\05_CMLW-232_07-OS2\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\06_CMLW-423_08-OS2\ANALYTICAL_CMLW42308OS2.pdf

02_Batch Analysis Tables\01_OSI-027AA\06_CMLW-423_08-OS2\BATCH_RECORD
yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\06_CMLW-423_08-OS2\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\07_CMLW-424_08-OS2\ANALYTICAL_CMLW42408OS2.pdf

02_Batch Analysis Tables\01_OSI-027AA\07_CMLW-424_08-OS2\BATCH_RECORD
yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\07_CMLW-424_08-OS2\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\08_CMLW-466_09-OS2\BATCH_RECORD
yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\08_CMLW-466_09-OS2\CMLW-466-09-OS2
Analytical.pdf

02_Batch Analysis Tables\01_OSI-027AA\08_CMLW-466_09-OS2\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\09_CMLW-467_09-OS2\BATCH_RECORD
yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\09_CMLW-467_09-OS2\CMLW-467-09-OS2
Analytical.pdf

02_Batch Analysis Tables\01_OSI-027AA\09_CMLW-467_09-OS2\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\10_CMLW-475_09-OS2\BATCH_RECORD
yield page.pdf

02_Batch Analysis Tables\01_OSI-027AA\10_CMLW-475_09-OS2\CMLW-475-09-OS2
Analytical.pdf

02_Batch Analysis Tables\01_OSI-027AA\10_CMLW-475_09-OS2\Presample
Page.pdf

02_Batch Analysis Tables\01_OSI-027AA\11_OS7-001 batch SAFC\step
2 analytical release.pdf

02_Batch Analysis Tables\01_OSI-027AA\11_OS7-001 batch SAFC\step
2 bmr extract.pdf

02_Batch Analysis Tables\01_OSI-027AA\12_OS7-002 SAFC\analytical
step 2.9x OSI-027AA.pdf

02_Batch Analysis Tables\01_OSI-027AA\12_OS7-002 SAFC\Yield
OSI-027AA OS7-002.pdf

02_Batch Analysis Tables\01_OSI-027AA\CML OSI-027RP Campaign
Report Batch CMLW-469-08-OS3 OCT2008.pdf

02_Batch Analysis Tables\01_OSI-027AA\CML OSI-027RP GMP Campaign
Report Batch CMLW-501-09-OS3 AUG2009.pdf

02_Batch Analysis Tables\02_OSI-027RP\01_AMRI 09100041\09100041
OSI COA.pdf

02_Batch Analysis Tables\02_OSI-027RP\01_AMRI 09100041\09100041
yield pages.pdf

02_Batch Analysis Tables\02_OSI-027RP\02_AMRI 09120061\OSI-027
API lot 09120061 CoA.pdf

02_Batch Analysis Tables\02_OSI-027RP\02_AMRI 09120061\OSI-027RP
09120061 CofA.pdf

02_Batch Analysis Tables\02_OSI-027RP\03_AMRI-Micron 111364\111364
Micron MBR.pdf

02_Batch Analysis Tables\02_OSI-027RP\03_AMRI-Micron 111364\OSI-027RP
lot 111364 Final Astellas Release documentation.pdf

02_Batch Analysis Tables\02_OSI-027RP\04_AMRI-Micron 121439\OSI-027
API lot 121439 CoA.pdf

02_Batch Analysis Tables\02_OSI-027RP\05_CML 970-95-1\970-95-1
Data.PDF

02_Batch Analysis Tables\02_OSI-027RP\05_CML 970-95-1\OSI-027
Tox lot COA 970-95-1.pdf

02_Batch Analysis Tables\02_OSI-027RP\06_CMLW-011_08-OS3\CMLW-011-08-OS3
BPR yield pre samples.pdf

02_Batch Analysis Tables\02_OSI-027RP\06_CMLW-011_08-OS3\CMLW-011-08-OS3
BPR yield.pdf

02_Batch Analysis Tables\02_OSI-027RP\06_CMLW-011_08-OS3\CMLW-011-08-OS3
Release specs_.pdf

02_Batch Analysis Tables\02_OSI-027RP\06_CMLW-011_08-OS3\OOS2008-006
micro.pdf

02_Batch Analysis Tables\02_OSI-027RP\07_CMLW-076-08-OS4\CMLW-076-08-OS4
BPR yield pre samples.pdf

02_Batch Analysis Tables\02_OSI-027RP\07_CMLW-076-08-OS4\CMLW-076-08-OS4
BPR yield.pdf

02_Batch Analysis Tables\02_OSI-027RP\07_CMLW-076-08-OS4\CMLW-076-08-OS4
OSI COA.pdf

02_Batch Analysis Tables\02_OSI-027RP\07_CMLW-076-08-OS4\CMLW-076-08-OS4.pdf

02_Batch Analysis Tables\02_OSI-027RP\08_CMLW-243_07-OS3\CMLW-24307-OS3
yield before samples.pdf

02_Batch Analysis Tables\02_OSI-027RP\08_CMLW-243_07-OS3\CMLW-24307-OS3-2
yield.pdf

02_Batch Analysis Tables\02_OSI-027RP\08_CMLW-243_07-OS3\CMLW-243-07-OS3finalanalytical.pdf

02_Batch Analysis Tables\02_OSI-027RP\08_CMLW-243_07-OS3\COA
CMLW-243-07-OS3.pdf

02_Batch Analysis Tables\02_OSI-027RP\09_CMLW-469_08-0S3\CMLW-469_08-0S3.pdf

02_Batch Analysis Tables\02_OSI-027RP\09_CMLW-469_08-0S3\CMLW-469-08-OS3
OSI COA.pdf

02_Batch Analysis Tables\02_OSI-027RP\09_CMLW-469_08-0S3\CMLW46908OS3_yield
after samples.pdf

02_Batch Analysis Tables\02_OSI-027RP\09_CMLW-469_08-0S3\CMLW46908OS3_yield
pre-samples.pdf

02_Batch Analysis Tables\02_OSI-027RP\09_CMLW-469_08-0S3\QC_TEST_RECORD_CMLW46908OS3.pdf

 

     

     

    

  

02_Batch Analysis Tables\02_OSI-027RP\09_CMLW-469_08-0S3\RESIDUAL_SOLVENT_DATA_TM451.pdf

02_Batch Analysis Tables\02_OSI-027RP\09_CMLW-469_08-0S3\TM454_IMPURITIES_AND_ASSAY_ANALYTICAL_DATA_NEW.pdf

02_Batch Analysis Tables\02_OSI-027RP\09_CMLW-469_08-0S3\TROMETHAMINE_DATA_TM455.pdf

02_Batch Analysis Tables\02_OSI-027RP\10_CMLW-501_09-OS3\CMLW-501-09-OS3
Analytical.pdf

02_Batch Analysis Tables\02_OSI-027RP\10_CMLW-501_09-OS3\CMLW-501-09-OS3
CoA.pdf

02_Batch Analysis Tables\02_OSI-027RP\10_CMLW-501_09-OS3\CMLW-501-09-OS3
yield after samples.pdf

02_Batch Analysis Tables\02_OSI-027RP\10_CMLW-501_09-OS3\CMLW-501-09-OS3
yield pre-samples.pdf

02_Batch Analysis Tables\02_OSI-027RP\11_MDM-X-186-3 AMRI demo
batch\AMRI Summary of Results.pdf

02_Batch Analysis Tables\02_OSI-027RP\11_MDM-X-186-3 AMRI demo
batch\OSI-027RP Demo Critical Test Data.pdf

02_Batch Analysis Tables\02_OSI-027RP\12_SAFC 1012OS701\1012OS701
CofA.pdf

02_Batch Analysis Tables\02_OSI-027RP\12_SAFC 1012OS701\OS7-002
bmr final released amount.pdf

02_Batch Analysis Tables\02_OSI-027RP\12_SAFC 1012OS701\OS7-002
bmr samples.pdf

02_Batch Analysis Tables\02_OSI-027RP\13_SAFC 1102OS701\1102OS701
BMR weights.pdf

02_Batch Analysis Tables\02_OSI-027RP\13_SAFC 1102OS701\1102OS701
COA.pdf

02_Batch Analysis Tables\02_OSI-027RP\14_SAFC 1004391017\CofA
OS7 Lot_1004391017.pdf

02_Batch Analysis Tables\02_OSI-027RP\14_SAFC 1004391017\Data
OS7 Lot_1004391017.pdf

02_Batch Analysis Tables\02_OSI-027RP\14_SAFC 1004391017\Qual
run campaign summary report.pdf

02_Batch Analysis Tables\02_OSI-027RP\15_SAFC 1008391022\OS7
Lot_1008391022 CofA.pdf

02_Batch Analysis Tables\02_OSI-027RP\15_SAFC 1008391022\OS7
lot_1008391022 data.pdf

02_Batch Analysis Tables\02_OSI-027RP\15_SAFC 1008391022\SAFC
OS7-001 campaign report Jan 11.pdf

02_Batch Analysis Tables\02_OSI-027RP\16_SAFC-Micron 111363\111363
Micron MBR.pdf

02_Batch Analysis Tables\02_OSI-027RP\16_SAFC-Micron 111363\OSI-027RP
lot 111363 Final Astellas Release documentation.pdf

02_Batch Analysis Tables\03_OSIP692940\01_AMRI IN-APR-E-175\IN-APR-E-175.pdf

02_Batch Analysis Tables\03_OSIP692940\01_AMRI IN-APR-E-175\R12011590.pdf

02_Batch Analysis Tables\03_OSIP692940\02_AMRI IN-GMR-B-103\OSIP692940
COA for batch_-IN-GMR-B-103.pdf

02_Batch Analysis Tables\03_OSIP692940\02_AMRI IN-GMR-B-103\OSIP692940,
Lot _ R10008003 Release Data Package.pdf

02_Batch Analysis Tables\03_OSIP692940\03_CML 975-11-4 07-1107-68\CML
LOT 07-1107-68.pdf

02_Batch Analysis Tables\03_OSIP692940\03_CML 975-11-4 07-1107-68\CML
OSIP692940 Manufacturing Report JUL2007.pdf

02_Batch Analysis Tables\03_OSIP692940\04_CML 975-11-41 07-1107-69\CML
LOT 07-1107-69.pdf

02_Batch Analysis Tables\03_OSIP692940\04_CML 975-11-41 07-1107-69\CML
OSIP692940 Manufacturing Report JUL2007.pdf

02_Batch Analysis Tables\03_OSIP692940\05_CML 975-48-2 07-3008-53\CML
LOT 07-3008-53 retest.pdf

02_Batch Analysis Tables\03_OSIP692940\05_CML 975-48-2 07-3008-53\CML
Lot 07-3008-53.pdf

02_Batch Analysis Tables\03_OSIP692940\06_SAFC 08196CM\SAFC
LOT 08196CM Sheboygan data.pdf

02_Batch Analysis Tables\03_OSIP692940\07_SAFC 85596MK MI 12067\SAFC
LOT 85596MK Sheboygan data.pdf

02_Batch Analysis Tables\03_OSIP692940\07_SAFC 85596MK MI 12067\SAFC
MI 12067 Madison data.pdf

02_Batch Analysis Tables\03_OSIP692940\07_SAFC 85596MK MI 12067\SAFC
Q4689-4 OSIP692940 20kg Jun 10.pdf

02_Batch Analysis Tables\04_OSIP699678\01_AMRI IN-BRP-D-86\Analytical
Results for IN-BRP-D-86.pdf

02_Batch Analysis Tables\04_OSIP699678\01_AMRI IN-BRP-D-86\HRC
COA IN-BRP-D-86.pdf

02_Batch Analysis Tables\04_OSIP699678\01_AMRI IN-BRP-D-86\OSIP699678,
Lot _ R10008041 Release Data Package.pdf

02_Batch Analysis Tables\04_OSIP699678\02_AMRI IN-BRP-D-94\IN-BRP-D-94
analytical data.pdf

02_Batch Analysis Tables\04_OSIP699678\02_AMRI IN-BRP-D-94\IN-BRP-D-94
CoA.pdf

02_Batch Analysis Tables\04_OSIP699678\02_AMRI IN-BRP-D-94\R10008241
Release Data.pdf

02_Batch Analysis Tables\04_OSIP699678\03_CML 06-1509-67 975-93-1\CML
Lot 06-1509-67 Release Data.pdf

02_Batch Analysis Tables\04_OSIP699678\03_CML 06-1509-67 975-93-1\report1-1.pdf

02_Batch Analysis Tables\04_OSIP699678\04_CML 07-2607-62\batch
size from report.pdf

02_Batch Analysis Tables\04_OSIP699678\04_CML 07-2607-62\CML
Lot 07-2607-62 Release Data.pdf

 

     

     

    

  

02_Batch Analysis Tables\04_OSIP699678\05_CML 07-2707-63\CML
Lot 07-2707-63 Release Data.pdf

02_Batch Analysis Tables\04_OSIP699678\06_CML 08-0107-69\CML
Lot 08-0107-69 Release Data.pdf

02_Batch Analysis Tables\04_OSIP699678\07_CML 08-2808-52 975-66-3\CML
Lot 08-2808-52 Release Data.pdf

02_Batch Analysis Tables\04_OSIP699678\08_SAFC 34996PK MI 12605\34996PK
Sheboygan COA.pdf

02_Batch Analysis Tables\04_OSIP699678\08_SAFC 34996PK MI 12605\SAFC
Lot 20000195259 Release Data.pdf

02_Batch Analysis Tables\04_OSIP699678\08_SAFC 34996PK MI 12605\SAFC
lot_34996PK Sheboygan data.pdf

02_Batch Analysis Tables\04_OSIP699678\08_SAFC 34996PK MI 12605\SAFC
Q4692-4 OSIP690678 9kg Jun 10.pdf

02_Batch Analysis Tables\04_OSIP699678\09_SAFC 65096DM\AMRI
R12011609 sample disposition summary.pdf

02_Batch Analysis Tables\04_OSIP699678\09_SAFC 65096DM\COA Q46924
lot 65096DM.pdf

02_Batch Analysis Tables\04_OSIP699678\10_SAFC MI 13049\COA
Escientia Lot ELS016-0610-001.pdf

02_Batch Analysis Tables\04_OSIP699678\10_SAFC MI 13049\OSIP699678
MI_13049 release data packet.pdf

02_Batch Analysis Tables\05_OSIP700068\01_09100038 AMRI\09100038
Release Data.pdf

02_Batch Analysis Tables\05_OSIP700068\01_09100038 AMRI\OSIP700068
09100038 yield page.pdf

02_Batch Analysis Tables\05_OSIP700068\02_09120058 AMRI\09120058
Release.pdf

02_Batch Analysis Tables\05_OSIP700068\03_CMLW-195_07-OS1\CMLW-195-07-OS1
Analytical.pdf

02_Batch Analysis Tables\05_OSIP700068\03_CMLW-195_07-OS1\CMLW-195-07-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\03_CMLW-195_07-OS1\CMLW-195-07-OS1
yield pre-samples.pdf

02_Batch Analysis Tables\05_OSIP700068\04_CMLW-206_07-OS1\CMLW-206-07-OS1
Analytical.pdf

02_Batch Analysis Tables\05_OSIP700068\04_CMLW-206_07-OS1\CMLW-206-07-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\04_CMLW-206_07-OS1\CMLW-206-07-OS1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\05_CMLW-207_07-OS1\CMLW-207-07-OS1
Analytical.pdf

02_Batch Analysis Tables\05_OSIP700068\05_CMLW-207_07-OS1\CMLW-207-07-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\05_CMLW-207_07-OS1\CMLW-207-07-OS1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\06_CMLW-210_07-OS1\CMLW-210-07-OS1
Analytical.pdf

02_Batch Analysis Tables\05_OSIP700068\06_CMLW-210_07-OS1\CMLW-210-07-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\06_CMLW-210_07-OS1\CMLW-210-07-OS1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\07_CMLW-393_08-OS1\Analytical_CMLW39308OS1.pdf

02_Batch Analysis Tables\05_OSIP700068\07_CMLW-393_08-OS1\CMLW-393-08-O1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\07_CMLW-393_08-OS1\CMLW-393-08-O1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\08_CMLW-401_08-OS1\Analytical_CMLW40108OS1.pdf

02_Batch Analysis Tables\05_OSIP700068\08_CMLW-401_08-OS1\CMLW-401-08-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\08_CMLW-401_08-OS1\CMLW-401-08-OS1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\09_CMLW-414_09-OS1\CMLW-414-09-OS1
QC.pdf

02_Batch Analysis Tables\05_OSIP700068\09_CMLW-414_09-OS1\CMLW-414-09-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\09_CMLW-414_09-OS1\CMLW-414-09-OS1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\10_CMLW-418_08-OS1\Analytical_CMLW41808OS1.pdf

02_Batch Analysis Tables\05_OSIP700068\10_CMLW-418_08-OS1\CMLW-418-08-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\10_CMLW-418_08-OS1\CMLW-418-08-OS1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\11_CMLW-419_08-OS1\Analytical_CMLW41908OS1.pdf

02_Batch Analysis Tables\05_OSIP700068\11_CMLW-419_08-OS1\CMLW-419-08-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\11_CMLW-419_08-OS1\CMLW-419-08-OS1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\12_CMLW-423_09-OS1\CMLW-423-09-OS1
QC.pdf

02_Batch Analysis Tables\05_OSIP700068\12_CMLW-423_09-OS1\CMLW-423-09-OS1
yield after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\12_CMLW-423_09-OS1\CMLW-423-09-OS1
yield pre samples.pdf

02_Batch Analysis Tables\05_OSIP700068\13_CMLW-424_09-OS1\CMLW-424-09-OS1
QC.pdf

02_Batch Analysis Tables\05_OSIP700068\13_CMLW-424_09-OS1\yield
after samples.pdf

02_Batch Analysis Tables\05_OSIP700068\13_CMLW-424_09-OS1\yield
pre-samples.pdf

02_Batch Analysis Tables\05_OSIP700068\14_OS7-001 batch SAFC\step
1 analytical release.pdf

02_Batch Analysis Tables\05_OSIP700068\14_OS7-001 batch SAFC\step
1 bmr page with yield.pdf

02_Batch Analysis Tables\05_OSIP700068\15_OS7-002 SAFC\OS7-002
step 1 OSIP700068 release.pdf

02_Batch Analysis Tables\05_OSIP700068\15_OS7-002 SAFC\OS7-002
Yield calculation.JPG

03_Contractors\01_AMRI\_0912150857_001 TSCA form.pdf

03_Contractors\01_AMRI\01_2012 API batch documentation\699678
release data AMRI Rec R12011609.pdf

 

     

     

    

  

03_Contractors\01_AMRI\01_2012 API batch documentation\OSIP692940,
Lot R12011590 Notebook Pages.pdf

03_Contractors\01_AMRI\01_2012 API batch documentation\OSIP692940,
Lot R12011590 Release Data Package.pdf

03_Contractors\01_AMRI\01_2012 API batch documentation\OSIP699678,
Lot R12011609 Notebook Pages.pdf

03_Contractors\01_AMRI\01_2012 API batch documentation\OSIP699678,
Lot R12011609 Release Data Package.pdf

03_Contractors\01_AMRI\02_COAs\111364 COA Not for Human use
pg 3.pdf

03_Contractors\01_AMRI\02_COAs\111364 OSI COA Revised 15-Jun-2012.pdf

03_Contractors\01_AMRI\02_COAs\Lot 09100041 and 111364\111364
Micron Test results for milled 09100041.pdf

03_Contractors\01_AMRI\02_COAs\Lot 09100041 and 111364\111364
Pd and Ir memo.pdf

03_Contractors\01_AMRI\02_COAs\Lot 09100041 and 111364\111364
Pd and Ir Testing memo 14-Oct-2011 .pdf

03_Contractors\01_AMRI\02_COAs\Lot 09100041 and 111364\AMRI
Summary of Results, OSI-027RP, Lot 111364 .pdf

03_Contractors\01_AMRI\02_COAs\Lot 09100041 and 111364\OSI-027RP,
Lot 111364 Data Package.pdf

03_Contractors\01_AMRI\02_COAs\Lot 09100041 and 111364\OSI-027RP,
Lot 111364 Notebook Pages.pdf

03_Contractors\01_AMRI\02_COAs\OSI-027 API lot 09120061 CoA.pdf

03_Contractors\01_AMRI\02_COAs\OSI-027 API lot 09120061 release.pdf

03_Contractors\01_AMRI\02_COAs\OSI-027 API lot 121439 CoA.pdf

03_Contractors\01_AMRI\02_COAs\OSI-027 API lot 121439 release.pdf

03_Contractors\01_AMRI\02_COAs\OSI-027RP 09120061_CoA.pdf

03_Contractors\01_AMRI\02_COAs\OSI-027RP AMRI COA Lot 09100041.pdf

03_Contractors\01_AMRI\02_COAs\OSI-027RP Lot 111364 COA Not
for Human Use.pdf

03_Contractors\01_AMRI\02_COAs\OSI-027RP lot 111364 Final Astellas
Release documentation (COA, Micron Release shipment, COC).pdf

03_Contractors\01_AMRI\02_COAs\OSI-027RP MTI Lot121439 CofA[2].pdf

03_Contractors\01_AMRI\02_COAs\pg 1.pdf

03_Contractors\01_AMRI\02_COAs\pg 2.pdf

03_Contractors\01_AMRI\03_Monographs\01_Starting Materials Mongoraphs\11642000
OSIP692940 v1 effective.pdf

03_Contractors\01_AMRI\03_Monographs\01_Starting Materials Mongoraphs\11642020
OSIP699678 v2 effective .pdf

03_Contractors\01_AMRI\03_Monographs\01_Starting Materials Mongoraphs\Approval
letter for OSIP699678 monograph v2 18-Oct-2010.pdf

03_Contractors\01_AMRI\03_Monographs\01_Starting Materials Mongoraphs\Approval
letter for OSIP692940 monograph 21-Sep-2010pdf.pdf

03_Contractors\01_AMRI\03_Monographs\01_Starting Materials Mongoraphs\Approval
letter OSIP699678 monograph v3 26-Mar-2012.pdf

03_Contractors\01_AMRI\03_Monographs\01_Starting Materials Mongoraphs\OSIP692940
V2.pdf

03_Contractors\01_AMRI\03_Monographs\01_Starting Materials Mongoraphs\OSIP699678
Monograph v3- Effective Date 3_30_12.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\21900000
IPC10 OSIP700068 Reactor Drying.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\21900000
IPC20 OSIP700068 Reaction Conversion of OSIP699678 to OSIP760500.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\21900000
IPC30 OSIP700068 Reaction Conversion of OSIP760500 to OSIP700024.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\21900000
IPC40 OSIP700068 Dryer Monitoring for OSIP700024.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\21900000
IPC50 OSIP700068 Reaction Conversion of OSIP700024 to OSIP700068.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\21900000
IPC60 OSIP700068 Dryer Monitoring for OSIP700068.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\21900000
OSIP700068.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\Approval
letter for IPC10 OSIP700068 Reactor Drying.pdf

 

     

     

    

  

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\Approval
letter for OSIP700068 21900000 IPC60 OSIP700068.pdf

03_Contractors\01_AMRI\03_Monographs\02_Stage 1 Monographs\Stage
1 Effective Monographs.pdf

03_Contractors\01_AMRI\03_Monographs\03_Stage 2 Monographs (027AA)\21901000
IPC20 OSI-027AA Residual Chloride Content.pdf

03_Contractors\01_AMRI\03_Monographs\03_Stage 2 Monographs (027AA)\21901000
IPC30 OSI-027AA Dryer Monitoring for OSI-027AA.pdf

03_Contractors\01_AMRI\03_Monographs\03_Stage 2 Monographs (027AA)\21901000
OSI-027AA Intermediate.pdf

03_Contractors\01_AMRI\03_Monographs\03_Stage 2 Monographs (027AA)\Approval
letter for OSI-027AA 21901000 IPC 30 Dryer Monitoring.pdf

03_Contractors\01_AMRI\03_Monographs\03_Stage 2 Monographs (027AA)\Approval
Letter for OSI-027AA 21901000 IPC20 Residual Chloride.pdf

03_Contractors\01_AMRI\03_Monographs\03_Stage 2 Monographs (027AA)\Approval
letter for OSI-027AA Intermediate.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\21902000
IPC10 OSI-027RP OSI-027RP Dryer Monitoring 16-Dec-2010.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\21902070
v 1.0 OSI-027RP Micronized.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\21902070
v 2.0 OSI-027RP Micronized.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\Approval
letter for Bulk OSI-027RP.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\Approval
letter for IPC 10 OSI-027RP Dryer Monitoring.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\Approval
lettter for IPC10 OSI-027RP Dryer Monitoring V2 .pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\non-effective
21902000 IPC10 OSI-027RP OSI-027RP Dryer Monitoring.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\OSI-027RP
Bulk Monograph, Revision 02 Effective Dec 2012.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\OSI-027RP
Effective Monograph.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\OSI-027RP
IPC10 Dryer Monitoring V2.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\OSI-027RP
Micronized Monograph v2.pdf

03_Contractors\01_AMRI\03_Monographs\04_Stage 3 Monographs (027RP)\OSI-027RP
Monograph V2 Effective Feb. 27 2012.pdf

03_Contractors\01_AMRI\7400-34-01 jet milled in CK- partial
testing at AMRI.pdf

03_Contractors\01_AMRI\7400-67-01 2x jet milled in CK CofA.pdf

03_Contractors\01_AMRI\7400-67-01 XRPD and PSD with dry dispersion.pdf

03_Contractors\01_AMRI\AMRI Proposal 111221-154605, 10kg of
micronized OSI-027, Jan 16, 2012.pdf

03_Contractors\01_AMRI\BSE-TSE lot 09100041.pdf

03_Contractors\01_AMRI\Campaign Summary Report.pdf

03_Contractors\01_AMRI\MDM-AA-6 in MeOD from use test of SM
for Aug 2012 campaign.pdf

03_Contractors\01_AMRI\Method change control form Res solv +
method approval TM2565.pdf

03_Contractors\01_AMRI\OOS-2011-0005.pdf

03_Contractors\01_AMRI\OSI-027RP 09100041 MBR.pdf

03_Contractors\01_AMRI\OSI-027RP 1kg demo batch report AMRI.pdf

03_Contractors\01_AMRI\Patheon memo for GMP storage of OSI-027RP
AMRI Lot 09100041.pdf

03_Contractors\01_AMRI\PSD with TM2650.pdf

03_Contractors\01_AMRI\signature pages for Res Solvent method
change-CAPA closure.pdf

03_Contractors\02_Cambridge Major\01_Chromatograms\AR-M620N_20080110_171114
AA and RP IPC.pdf

03_Contractors\02_Cambridge Major\01_Chromatograms\AR-M620N_20080126_144926.pdf

03_Contractors\02_Cambridge Major\01_Chromatograms\Cis-Spike.pdf

03_Contractors\02_Cambridge Major\01_Chromatograms\OSI-027 sodium
salt spike.pdf

 

     

     

    

  

03_Contractors\02_Cambridge Major\02_COA\970-95-1 Data.pdf

03_Contractors\02_Cambridge Major\02_COA\CML COA 970-95-1 Rev
1.pdf

03_Contractors\02_Cambridge Major\02_COA\CML REF STD COA 975-18-1.pdf

03_Contractors\02_Cambridge Major\02_COA\GMP batch data\current\CMLW-076-08-OS4
OSI COA 5-Nov-08 update.pdf

03_Contractors\02_Cambridge Major\02_COA\GMP batch data\current\CMLW-243-07-OS3
11-Mar-2011.pdf

03_Contractors\02_Cambridge Major\02_COA\GMP batch data\current\CMLW-469-08-OS3
OSI COA 11-Mar-2011pdf.pdf

03_Contractors\02_Cambridge Major\02_COA\GMP batch data\current\CMLW-469-08-OS3
OSI COA re-issue Jan-2011.pdf

03_Contractors\02_Cambridge Major\02_COA\GMP batch data\current\CMLW-469-08-OS3
OSI COA re-issue Feb 2012.pdf

03_Contractors\02_Cambridge Major\02_COA\GMP batch data\current\CMLW-501-09-OS3
OSI COA 11-Mar-2011.pdf

03_Contractors\02_Cambridge Major\02_COA\GMP batch data\XRPD
- particle size 2007-0433-CC.pdf

03_Contractors\02_Cambridge Major\02_COA\OSI COA 970-95-1 Tox
lot.pdf

03_Contractors\02_Cambridge Major\02_COA\OSI REF STD NOR RS-
975-18-1.pdf

03_Contractors\02_Cambridge Major\02_COA\OSI-027AQ CML COA 970-60-1.pdf

03_Contractors\02_Cambridge Major\027 interim COA.pdf

03_Contractors\02_Cambridge Major\027 Ref std Characterization
signature.pdf

03_Contractors\02_Cambridge Major\03_Impurities in OSI-027 and
synthesis\Structures for diacid impurity .pdf

03_Contractors\02_Cambridge Major\04_investigations\CHANGE_CONTROL_FINAL_PG3.pdf

03_Contractors\02_Cambridge Major\04_investigations\CHANGE_CONTROL_FINAL_PG4.pdf

03_Contractors\02_Cambridge Major\04_investigations\CHANGE_CONTROL_PG_1.pdf

03_Contractors\02_Cambridge Major\04_investigations\CHANGE_CONTROL_PG2.pdf

03_Contractors\02_Cambridge Major\04_investigations\OOS2008-006
micro inv CMLW-076-08-OS4.pdf

03_Contractors\02_Cambridge Major\05_Pd\CCH2-13-01 (FP-087 Pd
by ICP-OES).pdf

03_Contractors\02_Cambridge Major\05_Pd\QTI REPORT Ref std Aug-09.pdf

03_Contractors\02_Cambridge Major\05_Pd\WCAS Pd Ir result.pdf

03_Contractors\02_Cambridge Major\API retest plan for CML.pdf

03_Contractors\02_Cambridge Major\BSE-TSE Letter - 11-06-08.pdf

03_Contractors\02_Cambridge Major\BSETSE, OSI-027RP- Rev 1-
Signed 19-Dec-08.pdf

03_Contractors\02_Cambridge Major\CML CC.pdf

03_Contractors\02_Cambridge Major\CML HPLC method CC approval.pdf

03_Contractors\02_Cambridge Major\KF at Prevalere.pdf

03_Contractors\02_Cambridge Major\lot 2 identification.pdf

03_Contractors\02_Cambridge Major\Micro Investigation report
from Geneva-CML.pdf

03_Contractors\02_Cambridge Major\OSI COA CMLW-243-07-OS3.pdf

03_Contractors\02_Cambridge Major\OSI-027 COA.pdf

03_Contractors\02_Cambridge Major\OSI-027 Solution Stability
Memo 25-May-07.pdf

03_Contractors\02_Cambridge Major\OSI-027RP NOR Tox lot.pdf

03_Contractors\02_Cambridge Major\OSI-027RP Ref Std Report 1107
00.pdf

03_Contractors\02_Cambridge Major\ref std approvals 027.pdf

03_Contractors\02_Cambridge Major\Residual Solvent Validation
Protocol-CML.pdf

03_Contractors\02_Cambridge Major\Specificity Testing.pdf

03_Contractors\02_Cambridge Major\Tromethamine Valdation Protocol
signature.pdf

03_Contractors\03_Micron Technologies\09100041 XRPD.pdf

03_Contractors\03_Micron Technologies\101295-SOW fully executed.pdf

03_Contractors\03_Micron Technologies\121439 Particle Size initial.pdf

03_Contractors\03_Micron Technologies\121439.pdf

03_Contractors\03_Micron Technologies\7400-34-01 COA.pdf

03_Contractors\03_Micron Technologies\7400-34-01 XRPD.pdf

03_Contractors\03_Micron Technologies\7400-67-01 CofA.pdf

03_Contractors\03_Micron Technologies\7400-67-01 XRPD .pdf

03_Contractors\03_Micron Technologies\Acquisition letter to
clients 3-21-13.pdf

03_Contractors\03_Micron Technologies\certs of release 111363
and 111364.pdf

 

     

     

    

  

03_Contractors\03_Micron Technologies\Micron External Submission
Form signed 4-Jun-2012.pdf

03_Contractors\03_Micron Technologies\OSI-027 Samples Memo to
Micron Technologies-Peter Nelson .pdf

03_Contractors\03_Micron Technologies\OSI-027RP Ref std RS-975-18-1
IR spectrumt.pdf

03_Contractors\03_Micron Technologies\PSD and XRPD of Lot CMLW
501 09 OS3.pdf

03_Contractors\03_Micron Technologies\PSD with TM2650.pdf

03_Contractors\03_Micron Technologies\RS-975-18-1 XRPD.pdf

03_Contractors\03_Micron Technologies\XRPD and PSD with dry
dispersion.pdf

03_Contractors\03_Micron Technologies\XRPD-Micron Tech Report
2007-0547.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\ARF for AMRI
API 16-Mar-2011.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\ARF for CML
API, revised Mar-2011pdf.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\ARF for SAFC
-Micron 22-Sep-2011.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\memo to release
OSI-027RP API's SAFC and AMRI milled.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\OSI-027RP
ADRF revision memo.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\ovi.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\Patheon ARF
for OSI-027 from CML.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\Patheon OSI-027Analytical
Release Form Dec 08.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\Residual
Solvent letter for AMRI OSI-027RP to Patheon.pdf

03_Contractors\04_Patheon\01_ARFs Res Solv letters\Residual
Solvent letter for SAFC-Madison OSI-027RP to Patheon.pdf

03_Contractors\04_Patheon\02_COAs\01_2 year exp Updated Capsule
COA\20mg C1640A001 24m.pdf

03_Contractors\04_Patheon\02_COAs\01_2 year exp Updated Capsule
COA\5mg C1639A001 24m.pdf

03_Contractors\04_Patheon\02_COAs\02_3 year exp updated Capsule
COA\CoA C1639A001 Dec 2011.pdf

03_Contractors\04_Patheon\02_COAs\02_3 year exp updated Capsule
COA\CoA C1640A001 Dec 2011.pdf

03_Contractors\04_Patheon\02_COAs\03_5 year exp Updated Capsule
COA\OSI-027 20mg caps lot C1640A001 CoA.pdf

03_Contractors\04_Patheon\02_COAs\03_5 year exp Updated Capsule
COA\OSI-027 20mg caps lot CFVH CoA.pdf

03_Contractors\04_Patheon\02_COAs\03_5 year exp Updated Capsule
COA\OSI-027 20mg caps lot HBVC CoA.pdf

03_Contractors\04_Patheon\02_COAs\03_5 year exp Updated Capsule
COA\OSI-027 5mg caps lot C1639A001 CoA.pdf

03_Contractors\04_Patheon\02_COAs\03_5 year exp Updated Capsule
COA\OSI-027 5mg caps lot CFVG CoA.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\BU_HBVB.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\BU_OSI-027RP
20 mg Capsules Lot HBVB.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\CoA_BP_HBVB(20mg)_Corrected.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
20mg Capsules Lot C1640001 CofA (Bulk Product).pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
20mg Capsules Lot C1640A001 CofA (Finished Product).pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
5mg Capsules Lot C1639001 CofA (Bulk Product).pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
5mg Capsules Lot C1639A001 CofA (Finished Product).pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
blend CFVC moisture.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
blend uniformity CFVC set 1.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
blend uniformity OSI2GCOM0201.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
Capsules 20mg Lot CFVF CFVH Patheon COA.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
Capsules 5mg Lot CFVD CFVG Patheon COA.pdf

03_Contractors\04_Patheon\02_COAs\04_Patheon Release Cap data\OSI-027RP
Capsules, 20mg CoA_BP_HBVB - FP_HBVC.pdf

 

     

     

    

  

03_Contractors\04_Patheon\02_COAs\05_Tablets\BU_OSI2T005MG0501Pre-Blend
0601Pre-Blend_5 10 18 min 120MG0101 0201 5MG0401 0501 0601.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\BU_OSI2T5MG0201
100MG0501 100MG0601 100MG0701-Corrected.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027 100mg lot
HSNX CoA 25 Mar 2013.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027 100mg lot
HSNX release.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027 20mg lot
HSNT CoA 25 Mar 2013.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027 20mg lot
HSNT release.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027 50mg lot
HSNV CoA 25 Mar 2013.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027 50mg lot
HSNV release.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP 100mg
Core Tablet Lot OSI2T100MG0801.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP 20mg
Core Tablet Lot OSI2T20MG0101.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP 5mg Core
Tablet Lot OSI2T5MG0301.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP blend
uniformity OSI2T100mg0801 set 2.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP blend
uniformity OSI2T5mg0301 set 2.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Ribbon
Dimension Envelope Density OSI2GCOM0201.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablet
Ribbon Dimension Density_OSI2T005MG0401 0501 0601 120MG0101 0201.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1301.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1401.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1501.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1601.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
Blend Uniformity lot OSI2T100MG0501.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
Blend Uniformity lot OSI2T100MG0601.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
Blend Uniformity lot OSI2T100MG0701.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
Blend Uniformity lot OSI2T100MG1301.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
Blend Uniformity lot OSI2T100MG1401.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
Blend Uniformity lot OSI2T100MG1501.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
Blend Uniformity lot OSI2T100MG1601.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\OSI-027RP Tablets,
Blend Uniformity lot OSI2T5MG0201.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\Patheon BP and
FP COAs\HSNV(50mg) HSNT(20mg) HSNX(100mg)_FP_CoA.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\Patheon BP and
FP COAs\OSI-027RP Tablets, 100mg HMCT.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\Patheon BP and
FP COAs\OSI-027RP Tablets, 20mg HMCK.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\Patheon BP and
FP COAs\OSI-027RP Tablets, 50mg HMCP.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\SPL-1208107-P 20
mg Feas CU.pdf

03_Contractors\04_Patheon\02_COAs\05_Tablets\SPL-1208108-P 50
mg Feas CU.pdf

03_Contractors\04_Patheon\02_COAs\OSI-027 Astellas QA release
HBVC 20 mg caps.pdf

03_Contractors\04_Patheon\02_COAs\OSI-027 CoA lot HBVC 20 mg
caps 18-Jun-2012.pdf

03_Contractors\04_Patheon\02_COAs\OSI-027RP 20 mg Capsules Lot
CFVH COA.pdf

03_Contractors\04_Patheon\02_COAs\OSI-027RP 5 mg Capsules Lot
CFVG COA.pdf

03_Contractors\04_Patheon\027 cap micro verification memo.pdf

03_Contractors\04_Patheon\027 tablet micro verification memo.pdf

03_Contractors\04_Patheon\03_Investigations\Attachment 1_Investigation
50717.pdf

03_Contractors\04_Patheon\03_Investigations\HMCT_UR_52444.pdf

03_Contractors\04_Patheon\04_Method Qual data-First Methods\027
Cleaning method.pdf

 

     

     

    

  

03_Contractors\04_Patheon\04_Method Qual data-First Methods\AS_RS
Method CTMLP-2208 R 1 AS-RS + MV summary data.pdf

03_Contractors\04_Patheon\04_Method Qual data-First Methods\Diss
Method CTMLP-2209 R 1 Dissolution + MV summary data.pdf

03_Contractors\04_Patheon\04_Method Qual data-First Methods\Diss
MV report.pdf

03_Contractors\04_Patheon\04_Method Qual data-First Methods\Final
signature for AS-RS MV Reprot.pdf

03_Contractors\04_Patheon\04_Method Qual data-First Methods\OSI
MV Protocol for Assay and RS of OSI-027RP Capsules 13-Jan-09.pdf

03_Contractors\04_Patheon\04_Method Qual data-First Methods\OSI
MV Protocol for Dissolution of OSI-027RP Capsules 13-Jan-09.pdf

03_Contractors\04_Patheon\04_Method Qual data-First Methods\OSI-AR-056-0309-RO
MV report OSI-027RP Capsule Dissolution Phase 1.pdf

03_Contractors\04_Patheon\04_Method Qual data-First Methods\OSI-AR-057-0309-R0
MV Report OSI-027RP Capsules AS-RS Phase 1.pdf

03_Contractors\04_Patheon\05_Specs\20 and 5 mg OSI-027 cap BP
specs rev 6-Jun-2012 .pdf

03_Contractors\04_Patheon\05_Specs\20mg cap Patheon BP spec.pdf

03_Contractors\04_Patheon\05_Specs\20mg cap Patheon FP spec.pdf

03_Contractors\04_Patheon\05_Specs\5mg cap Patheon BP spec.pdf

03_Contractors\04_Patheon\05_Specs\5mg cap Patheon FP spec.pdf

03_Contractors\04_Patheon\05_Specs\OSI_027RP 20 mg Capsules_BP.R1
OSI-SPEC-045-0109-R1.pdf

03_Contractors\04_Patheon\05_Specs\OSI_027RP 5 mg Capsules_BP.R1
OSI-SPEC-044-0109-R1.pdf

03_Contractors\04_Patheon\05_Specs\Tablets\BP_Spec_OSI-027RP
Tab_100mg_OSI-SPEC-107-0512-R0.pdf

03_Contractors\04_Patheon\05_Specs\Tablets\BP_Spec_OSI-027RP
Tab_20mg_OSI-SPEC-106-0512-R0.pdf

03_Contractors\04_Patheon\05_Specs\Tablets\BP_Spec_OSI-027RP
Tab_50mg_OSI-SPEC-105-0512-R0.pdf

03_Contractors\04_Patheon\05_Specs\Tablets\FP_Spec_OSI-027RP
Tab_100mg_OSI-SPEC-104-0512-R0.pdf

03_Contractors\04_Patheon\05_Specs\Tablets\FP_Spec_OSI-027RP
Tab_20mg_OSI-SPEC-103-0512-R0.pdf

03_Contractors\04_Patheon\05_Specs\Tablets\FP_Spec_OSI-027RP
Tab_50mg_OSI-SPEC-102-0512-R0.pdf

03_Contractors\04_Patheon\API release letter - 20090108103654965.pdf

03_Contractors\04_Patheon\CC to extend milled API to 9 months
Patheon doc 2012-OS-0568.pdf

03_Contractors\04_Patheon\Client Letter - OSI-027RP.pdf

03_Contractors\04_Patheon\CTMLP2209_R2_OSI-027RP Cap_Disso 29-Sep-2011
OSi approvalpdf.pdf

03_Contractors\04_Patheon\CTMLP2209_R2_OSI-027RP Cap_Disso.pdf

03_Contractors\04_Patheon\Data sheets for OSI-027 to Patheon.pdf

03_Contractors\04_Patheon\MA_005C OSI-027 Caps.pdf

03_Contractors\04_Patheon\Memo-OSI-027RP CRT.pdf

03_Contractors\04_Patheon\OOS Client Detailed Report- OOS 50717.pdf

03_Contractors\04_Patheon\OOS_52444_Client Report. + Att 1 +
OSI Sign off 23-Jul-2012pdf.pdf

03_Contractors\04_Patheon\OOS_52444_Client Report. + OSI Sign
off 23-Jul-2012pdf.pdf

03_Contractors\04_Patheon\res solvent letter OSI-027.pdf

03_Contractors\05_PII\01_Capsules\01_2007 Clinical Batches\027
release docs.pdf

03_Contractors\05_PII\01_Capsules\01_2007 Clinical Batches\13802.001A
Packaging Record.pdf

03_Contractors\05_PII\01_Capsules\01_2007 Clinical Batches\13803.001A
Packaging Record.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\01_2 year exp update
COAs\20mg 13803.001A 24m.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\01_2 year exp update
COAs\20mg 13803.002A 24m.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\01_2 year exp update
COAs\5mg 13802.001A 24m.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\01_2 year exp update
COAs\5mg 13802.002A 24m.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\02_3 year Exp update
COAs\CoA 13802.001A Oct 2010.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\02_3 year Exp update
COAs\CoA 13802.002A Mar 2011.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\02_3 year Exp update
COAs\CoA 13803.001A Oct 2010.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\02_3 year Exp update
COAs\CoA 13803.002A Mar 2011.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\027 cofa 13802-001A
and 13803-001A final 5-Mar-08.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\13802.002 rev1.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\13803.001 record.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\13803.002 rev 1.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\20080212093724706.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\COA 20 mg caps 13803.002A
2-Mar-09.pdf

 

     

     

    

  

03_Contractors\05_PII\01_Capsules\02_COAs\COA 5 mg caps 13802.002A
2-Mar-09.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\Cof A 20mg capsule
Lot 13803-001A Rev 2 30-Apr-08.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\Cof A 5mg capsule
Lot 13802-001A Rev 2 30-Apr-08.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\OSI COA 13802.001A
rev 14-Jul-08.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\OSI COA 13802-002A
5mg 14-Jul-08.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\OSI COA 13803.001A
rev 14-Jul-08 .pdf

03_Contractors\05_PII\01_Capsules\02_COAs\OSI COA 13803-002A
20mg CofA.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\OSI CofA 13803-001
and 13802-001.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\Pii CofA 13801.002
common blend.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\Pii CofA 13802.002
5mg.pdf

03_Contractors\05_PII\01_Capsules\02_COAs\Pii CofA 13803.002
20mg.pdf

03_Contractors\05_PII\01_Capsules\03_Specifications\OSI-027
Capsules 5mg 20mg Release Testing Specifications.pdf

03_Contractors\05_PII\01_Capsules\F-2484-019B-TR07-1915_DP.PDF

03_Contractors\05_PII\01_Capsules\F-2484-019B-TR07-1916_DP.PDF

03_Contractors\05_PII\01_Capsules\F-2484-021-TR07-1943_DP.PDF

03_Contractors\05_PII\01_Capsules\Feasibility 1 month satb data-except
dissol.pdf

03_Contractors\05_PII\01_Capsules\OSI-Data Summary.pdf

03_Contractors\05_PII\02_Data Disk\15-OSP.pdf

03_Contractors\05_PII\02_Data Disk\16-OSP.pdf

03_Contractors\05_PII\02_Data Disk\17-OSP.pdf

03_Contractors\05_PII\02_Data Disk\21 and 22-OSP.pdf

03_Contractors\05_PII\02_Data Disk\23-OSP.pdf

03_Contractors\05_PII\02_Data Disk\24-OSP.pdf

03_Contractors\05_PII\02_Data Disk\30-OSP.pdf

03_Contractors\05_PII\02_Data Disk\31-OSP.pdf

03_Contractors\05_PII\02_Data Disk\32,33-OSP.pdf

03_Contractors\05_PII\02_Data Disk\34,35,36-OSP.pdf

03_Contractors\05_PII\02_Data Disk\5-OSP.pdf

03_Contractors\05_PII\03_Dose solution method and validation
protocol and report\14OSP02- VP 1824.pdf

03_Contractors\05_PII\03_Dose solution method and validation
protocol and report\PII VP 1824 DN signature page.pdf

03_Contractors\05_PII\03_Dose solution method and validation
protocol and report\TM 07-0124.00.pdf

03_Contractors\05_PII\04_EMEA\080619 redacted response EMEA.pdf

03_Contractors\05_PII\04_EMEA\080915 Redacted EMEA report, 2008.pdf

03_Contractors\05_PII\04_EMEA\081008, redacted reply to EMEA.pdf

03_Contractors\05_PII\04_EMEA\EMEA Report 4 10 08.pdf

03_Contractors\05_PII\04_EMEA\OSI API_QP responsibilities.pdf

03_Contractors\05_PII\05_PII Investigations\DP 07_297.01.pdf

03_Contractors\05_PII\05_PII Investigations\DP 07_299.01.pdf

03_Contractors\05_PII\05_PII Investigations\PII CC 08-0294.pdf

03_Contractors\05_PII\05_PII Investigations\PII CC 08-0296.pdf

03_Contractors\05_PII\05_PII Investigations\PII CC 08-0297.pdf

03_Contractors\05_PII\05_PII Investigations\PII CC 08-0298.pdf

03_Contractors\05_PII\05_PII Investigations\STAB 07_298.01.pdf

03_Contractors\05_PII\05_PII Investigations\STAB 07_300.01.pdf

03_Contractors\05_PII\05_PII Investigations\TM 07_0243.01.pdf

03_Contractors\05_PII\11-Jun-07 PII Memo.pdf

03_Contractors\05_PII\14OSP02_Approval.pdf

03_Contractors\05_PII\14OSP02_ChangeOrder.pdf

03_Contractors\05_PII\14OSP06-signed.pdf

03_Contractors\05_PII\14OSP06-stability section.pdf

03_Contractors\05_PII\Clinical lots Content Uniformity Data.pdf

03_Contractors\05_PII\Dosing Formulation Preparations.pdf

03_Contractors\05_PII\OSI-027RP Preformulation Development Report_Work
Performed at Pii.pdf

03_Contractors\05_PII\PCRS reshipment 0703 doc, 20071204091158521.pdf

 

     

     

    

  

03_Contractors\05_PII\PII GMP statement for Clincial product
release.pdf

03_Contractors\05_PII\PII GMP statement.pdf

03_Contractors\05_PII\Pii_-QA letter to Kim Potter June-08.pdf

03_Contractors\06_SAFC\01_BSE-TSE\1102OS701 CoO BSE-TSE.pdf

03_Contractors\06_SAFC\02_COAs\111363 COA Revised 15-Jun-2012.pdf

03_Contractors\06_SAFC\02_COAs\OSI-027RP (SAFC) 1008391022.pdf

03_Contractors\06_SAFC\02_COAs\OSI-027RP (SAFC) 1102OS701.pdf

03_Contractors\06_SAFC\02_COAs\OSI-027RP (SAFC) 111363.pdf

03_Contractors\06_SAFC\02_COAs\OSI-027RP lot 111363 Final Astellas
Release documentation (COA, Micron Shipment release form, CoC) .pdf

03_Contractors\06_SAFC\03_Deviations\1010-607 for PROC-MAD-From-004805
changing batch to non-GMP.pdf

03_Contractors\06_SAFC\03_Deviations\2010-536 for BR-MAD-MBR-009113
v.1.0.pdf

03_Contractors\06_SAFC\03_Deviations\2011-187.pdf

03_Contractors\06_SAFC\03_Deviations\Deviation Approval 2011-187
storage condition and shelf-life.pdf

03_Contractors\06_SAFC\03_Deviations\OSI approval letter for
Dev 2011-187 -storage condition and shelf-life.pdf

03_Contractors\06_SAFC\04_Particle Size and Pd\Micron data on
388-54-1 and 388-56-2.pdf

03_Contractors\06_SAFC\04_Particle Size and Pd\OS7 Lot 1002388054
Particle size image analysis.pdf

03_Contractors\06_SAFC\04_Particle Size and Pd\SAFC non-GMP
batch 1008391022.pdf

03_Contractors\06_SAFC\04_Particle Size and Pd\SKMBT_C36010122208580
OS7-002.pdf

03_Contractors\06_SAFC\05_Pd analyses\AD10-0210 Pd Ir result
10-Dec-10.pdf

03_Contractors\06_SAFC\05_Pd analyses\AD10-0212 Pd Ir results
21-Dec-10 for OS7-002.pdf

03_Contractors\06_SAFC\05_Pd analyses\AD10-0212 Pd and Ir results
for OSI-027RP Lot OS7-002.pdf

03_Contractors\06_SAFC\05_Pd analyses\AD11-0043 Pd Ir OS7R-001
28-Feb-2011.pdf

03_Contractors\06_SAFC\06_SAFC Packaging\Madison\200-543 v2.0.pdf

03_Contractors\06_SAFC\06_SAFC Packaging\Madison\200-555 v3.0.pdf

03_Contractors\06_SAFC\07_Specifications (SAFC)\SPEC-MAD-FPS-009261
v2.0.pdf

03_Contractors\06_SAFC\07_Specifications (SAFC)\SPEC-MAD-RMS-009242
v. 5.0 (OSIP699678).pdf

03_Contractors\06_SAFC\07_Specifications (SAFC)\SPEC-MAD-RMS-009342
v3.0 (OSIP692940).pdf

03_Contractors\06_SAFC\1102OS701- Micronized OSI-027RP data
Lot 111363.pdf

03_Contractors\06_SAFC\111363.pdf

03_Contractors\06_SAFC\CofA OS7 Lot 1004391017.pdf

03_Contractors\06_SAFC\CofAv2 OS7 Lot 1002388054 (revised metals).pdf

03_Contractors\06_SAFC\Final signature Fianl Product Label PROC-MAD-OP-014429.pdf

03_Contractors\06_SAFC\IR from 1102OS701- Micronized OSI-027RP
data Lot 111363 release.pdf

03_Contractors\06_SAFC\IR of RS-975-18-1 OSI-027RP.pdf

03_Contractors\06_SAFC\OS7 Hazard Evaluation.pdf

03_Contractors\06_SAFC\OS7 Qual Run Report.pdf

03_Contractors\06_SAFC\OSI Approval FPS-009261v1.16.pdf

03_Contractors\06_SAFC\OSIP692940 HPLC scan by ATP-LC-076.pdf

03_Contractors\06_SAFC\Q46924 lot 34996PK. COApdf.pdf

03_Contractors\06_SAFC\Quality Agreement - SAFC 6-8-10 AAS.pdf

03_Contractors\06_SAFC\Quality Agreement - SAFC 6-8-10.pdf

03_Contractors\06_SAFC\Sheboygan Meeting Notes 11.19.09.pdf

03_Contractors\07_Xcelience\31Mar2010 meeting minutes.pdf

03_Contractors\07_Xcelience\OSI-027RP development report on
AA formation and method of detection.pdf

03_Contractors\07_Xcelience\QN09043 Rev 1.pdf

03_Contractors\07_Xcelience\qn09043 rev 2.pdf

03_Contractors\07_Xcelience\Telephone Conversation Log 22Mar2010.pdf

04_MSDS\OSI-027AA MSDS 44 5-31-2007.pdf

04_MSDS\OSI-027AQ MSDS 43 5-31-2007.pdf

04_MSDS\OSI-027RP Capsules MSDS 54 10-31-2008.pdf

04_MSDS\OSI-027RP MSDS 46 01-25-2010.pdf

04_MSDS\OSIP692940AA MSDS 75 7-30-2009.pdf

04_MSDS\OSIP692940AA MSDS 75 7-30-2009.pdf

04_MSDS\OSIP699678 MSDS 45 5-31-2007.pdf

04_MSDS\OSIP700024AA MSDS 84 3-1-2011.pdf

 

     

     

    

  

04_MSDS\OSIP700068AA MSDS 85 3-1-2011.pdf

05_Packaging\01_AMRI-India Starting Materials\Associated Bag
Invoice Y851366 for 4-mil bags 28-6-610.pdf

05_Packaging\01_AMRI-India Starting Materials\Associated bag
LDPE MSDS.pdf

05_Packaging\02_AMRI-RSL\3-mil LDPE bags (AMRI-RSL).pdf

05_Packaging\03_clinical\OSI-027 Capsule Subdispensing Memo_Final
090911.pdf

05_Packaging\04_Drums for Stability - Greif Bros\41560 Greif
drums.pdf

05_Packaging\05_Micron Technologies\PM030 - 15 Gallon Poly Liner
- Flat001.pdf

05_Packaging\06_Patheon\2011-PA-1535-Part 1.pdf

05_Packaging\06_Patheon\2012-PA-0147 - Part 1 cc.pdf

05_Packaging\06_Patheon\33mm CRC cap.pdf

05_Packaging\06_Patheon\OSI 027RP Tablets in Blisters for Stability
OSI-MIS-083-0811-R1.pdf

05_Packaging\06_Patheon\PVC white opaque 10-mil blister Klockner.pdf

05_Packaging\06_Patheon\Spec added 09-14-2011.pdf

05_Packaging\07_SAFC-Sheboygan Starting Material Bags\104-6-21.pdf

05_Packaging\07_SAFC-Sheboygan Starting Material Bags\Antistatic
agent info and MSDS used in pink bags from SAFC-Sheboygan.pdf

05_Packaging\07_SAFC-Sheboygan Starting Material Bags\Associated
Bag Invoice Y851365 for 4-mil bags pink 104-6-21.pdf

06_Pharm Dev\01_Batch Records\OSI-027RP Lab Notebook Scan (RC
trials - Oct 2110 P40 to 15).pdf

06_Pharm Dev\01_Batch Records\OSI-027RP Lab Notebook Scan (Roller
Compaction).pdf

06_Pharm Dev\01_Batch Records\OSI-027RP Lab Notebook Scan 8
- GCOM0201 20MG0201 50MG0101 100MG1701.pdf

06_Pharm Dev\01_Batch Records\OSI-027RP Lab Notebook Scan.pdf

06_Pharm Dev\01_Batch Records\OSI2T005MG0401 - Blending, RC,
Compression.txt.pdf

06_Pharm Dev\01_Batch Records\OSI2T005MG0401 0501 0601 OSI2T120MG0101
0201 - High Low Compression Profile.pdf

06_Pharm Dev\01_Batch Records\OSI2T005MG0401 0501 0601 OSI2T120MG0101
0201 - Ribbon Dimensions Density.pdf

06_Pharm Dev\01_Batch Records\OSI2T005MG0401, 0501, 0601, OSI2T120MG0101,
0201 - Coating.pdf

06_Pharm Dev\01_Batch Records\OSI2T005MG0501 - Blending, RC,
Compression.txt.pdf

06_Pharm Dev\01_Batch Records\OSI2T005MG0601 - Blending, RC,
Compression.txt.pdf

06_Pharm Dev\01_Batch Records\OSI2T100MG1301.pdf

06_Pharm Dev\01_Batch Records\OSI2T100MG1401.pdf

06_Pharm Dev\01_Batch Records\OSI2T100MG1501.pdf

06_Pharm Dev\01_Batch Records\OSI2T100MG1601.pdf

06_Pharm Dev\01_Batch Records\OSI2T120MG0101 - Blending, RC,
Compression.txt.pdf

06_Pharm Dev\01_Batch Records\OSI2T120MG0201 - Blending, RC,
Compression.txt.pdf

06_Pharm Dev\01_Batch Records\SHARP_PM_AREA_20110126_092453.pdf

06_Pharm Dev\02_BSE TSE\BSE TSE Free Statement - OSI Pharma
(OSI-027) Capsules - April 2012.pdf

06_Pharm Dev\03_Development Reports\OSI027RP PII Report 1675
OSI Formulation Feasibility Work.pdf

06_Pharm Dev\03_Development Reports\OSI027RP PII Report 2286
Preformulation Develop Work.pdf

06_Pharm Dev\03_Development Reports\PD027-13-001.00 OSI-027RP
Phase 1 Capsule Formulation Development.pdf

06_Pharm Dev\03_Development Reports\PD027-13-002.00 OSI-027RP
Capsule Process Development Work at Patheon.pdf

06_Pharm Dev\04_PK\Study R2012010 027 capsule-tablet pk.pdf

07_Process Research\01_API for PII (tromethamine salt from FD)\Batch
5986-15-2 OSI027RP CofA signed.pdf

07_Process Research\01_API for PII (tromethamine salt from FD)\Batch
Document 5893-50-1 CofA.pdf

07_Process Research\02_API Process Impurities\OSIP760157 dimer
control sample.pdf

07_Process Research\03_Batch Records\01_AMRI-Micron Lot 111364\111364
Micron MBR.pdf

07_Process Research\03_Batch Records\01_AMRI-Micron Lot 111364\OSI-027AA
09100040.pdf

07_Process Research\03_Batch Records\01_AMRI-Micron Lot 111364\OSI-027RP
09100041.pdf

07_Process Research\03_Batch Records\01_AMRI-Micron Lot 111364\OSIP700068
09100038.pdf

07_Process Research\03_Batch Records\02_AMRI-Micron Lot 121439\OSI027_MicronBatchRecord_121439.pdf

07_Process Research\03_Batch Records\02_AMRI-Micron Lot 121439\OSI-027AA
09120060_BR.pdf

07_Process Research\03_Batch Records\02_AMRI-Micron Lot 121439\OSI-027RP
09120061_BR.pdf

 

     

     

    

  

07_Process Research\03_Batch Records\02_AMRI-Micron Lot 121439\OSIP700068
09120058.pdf

07_Process Research\04_Chemistry\Structures and names for OSI-027
compounds.pdf

07_Process Research\05_Reports\01_Development Reports\OSI-027-REP-01.pdf

07_Process Research\05_Reports\01_Development Reports\OSI-027-REP-02.pdf

07_Process Research\05_Reports\01_Development Reports\OSI-027-REP-03.pdf

07_Process Research\05_Reports\01_Development Reports\OSI-027-REP-04.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\AMRI
OSI-027RP 1kg demo batch report AMRI.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\AMRI
OSI-027RP GMP Manufacturing Report 04-11-2011.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\AMRI
OSIP692940 Manufacturing Report Lot IN-GMR-B-103.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\AMRI
OSIP699678 Manufacturing Report Lot IN-BRP-D-86 and -94.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\AMRI
Use test of OSIP699678 and OSIP692940 Aug2012.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\CML
OSI-027AQ Development Report 200g MAR2007.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\CML
OSI-027RP Campaign Report Batch CMLW-469-08-OS3 OCT2008.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\CML
OSI-027RP GMP Campaign Report Batch CMLW-501-09-OS3 AUG2009.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\CML
OSIP692940 Manufacturing Report JUL2007.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\CML
OSIP692940 Manufacturing Report JUL2008.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\CML
Preparation of OSIP699677 JUN2007.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\SAFC
Madison OSI-027RP GMP Campaign Report Batch 1012OS701.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\SAFC
Madison OSI-027RP non-GMP campaign report Batch 1008391022.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\SAFC-Madison
OSI-027RP Process Development Report.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\SAFC-Madison
OSI-027RP Qualification Batch Report.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\SAFC-Sheboygan
OSIP692940 Campaign Report JUN2010.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\SAFC-Sheboygan
OSIP692940 Development Report.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\SAFC-Sheboygan
OSIP699678 campaign report JUN2010.pdf

07_Process Research\05_Reports\02_Manufacturing Reports\SAFC-Sheboygan
OSIP699678 Development Report.pdf

07_Process Research\06_Solid State - Salt Screen and Polymorph\OSI-027AQ\OSI-027AQ
Prelim Stability Study.pdf

07_Process Research\06_Solid State - Salt Screen and Polymorph\SSCI
polymorph and salt screen report.pdf

08_Reference Standard\01_Catalent Protocols\TTP-OLR-M0139.04.pdf

08_Reference Standard\01_Catalent Protocols\TTP-OLR-M0143.00.pdf

08_Reference Standard\02_Notifications of Retest\cis-OSI-027(OSIP700607)AM2.2.pdf

08_Reference Standard\02_Notifications of Retest\NOR OSI-027RPWRS2.3
Nov 2014.pdf

08_Reference Standard\02_Notifications of Retest\OSIP692940AAWRS1.4.pdf

08_Reference Standard\02_Notifications of Retest\OSIP699678AAWRS1.4.pdf

08_Reference Standard\02_Notifications of Retest\OSIP700024AAAM2.2.pdf

08_Reference Standard\02_Notifications of Retest\OSIP700068AAAM2.2.pdf

08_Reference Standard\03_Recertification Protocols\cis-OSI-027
Retest Protocol 2.0.pdf

08_Reference Standard\03_Recertification Protocols\OSI-027RP
Retest Protocol 2.1.pdf

08_Reference Standard\03_Recertification Protocols\OSIP692940
Retest Protocol 1.2.pdf

 

     

     

    

  

08_Reference Standard\03_Recertification Protocols\OSIP699678
Retest Protocol 1.2.pdf

08_Reference Standard\03_Recertification Protocols\OSIP700024AA
Retest Protocol 2.1.pdf

08_Reference Standard\03_Recertification Protocols\OSIP700068AA
Retest Protocol 2.1.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\AD11-0137 OSIP692940-1.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\AD11-0138 OSIP699678-1.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\cis-OSI-027 H1 NMR Spectrum - lot RS-6683-22-3.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSI-027RP IR spectrum - lot RS-111363.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSI-027RP IR Spectrum - lot RS-975-18-1.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSI-027RP IR spectrum lot RS-111363.JPG

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP692940 FTIR Spectrum - lot RS-08196CM.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP692940 H1 NMR - lot RS-08196CM.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP699678 H1 NMR Spectrum - lot RS-6986-2-1.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP699678 IR Spectrum - lot RS-6986-2-1.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700024 H1 NMR Spectrum + HPLC - lot RS-5846-21-03 Sep 2011.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700024 H1 NMR Spectrum + HPLC - lot RS-5846-21-03.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700024 IR Spectrum - lot RS-5846-21-03.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700024 IR spectrum lot RS-7202-23-3.JPG

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700024 NMR Spectra - lot RS-7202-23-3.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700068 H1 NMR Spectrum- lot RS-970-87-1.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700068 IR Spectrum lot RS-7331-5-4.JPG

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700068 IR Spectrum- lot RS-970-87-1.pdf

08_Reference Standard\03_Recertification Protocols\Reference
Scans\OSIP700068 NMR Spectra- lot RS-7331-5-4.pdf

08_Reference Standard\04_Retest Data\1H NMR for OSIP699678 ultrapure
ref std 7202-15-5.pdf

08_Reference Standard\04_Retest Data\OSI-027RPWRS2.2.pdf

08_Reference Standard\04_Retest Data\OSI-027RPWRS2.3.pdf

08_Reference Standard\04_Retest Data\OSIP692940AA 16-May-2013.pdf

08_Reference Standard\04_Retest Data\OSIP699678 ref std char
7202-15-5.pdf

08_Reference Standard\04_Retest Data\OSIP699678AA 20-May-2013.pdf

08_Reference Standard\04_Retest Data\OSIP700024AAAM2.2.pdf

08_Reference Standard\04_Retest Data\OSIP700068AAAM2.2.pdf

09_Safety\OHC OSI-027RP.pdf

09_Safety\OSI-027 PCCR.PDF

10_Stability\01_Investigations\INV08-0166 Pii 6month 40C-75RH
lot 13802.001A.pdf

10_Stability\01_Investigations\Pii investigation to missing
samples at time of transfer to Patheon.pdf

10_Stability\02_Photostability\AD12-008 Photostability of OSI-027RP.pdf

10_Stability\02_Photostability\post exposure image of TTP-OLR-M0134
- lot 111364.jpg

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-00Month-CML-W-243-07-OS3-R002.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-12Month-CML-W-243-07-OS3-R001.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-18Month-CML-W-243-07-OS3-R001.pdf

 

     

     

    

  

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-1Month-CML-W-243-07-OS3-R001.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-24Month-CML-W-243-07-OS3.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-36Month-CML-W-243-07-OS3.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-3Month-CML-W-243-07-OS3-R001.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-48Month-CML-W-243-07-OS3.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-60Month-CML-W-243-07-OS3.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-6Month-CML-W-243-07-OS3-R001.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\01_M0090\OLR-M0090-9Month-CML-W-243-07-OS3-R001.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-
Deviation PR 156230.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-00
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-03
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-06
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-09
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-12
Month DSC Investigation PR219811.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-12
Month-CML-W-076-08-OS4-R001.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-18
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-24
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-36
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-48
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\02_M0095\OLR-M0095-60
Month-CML-W-076-08-OS4.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\03_M0118\TTP-OLR-M0118-01Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\03_M0118\TTP-OLR-M0118-03Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\03_M0118\TTP-OLR-M0118-06Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\03_M0118\TTP-OLR-M0118-09Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\03_M0118\TTP-OLR-M0118-12Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\03_M0118\TTP-OLR-M0118-18Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\03_M0118\TTP-OLR-M0118-24Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\03_M0118\TTP-OLR-M0118-Initial-1008391022.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\OLR-M0129
00 Initial.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\OLR-M0129
01 month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\OLR-M0129
03 month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\OLR-M0129
06 month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\OLR-M0129
09 month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\TTP-OLR-M0129
12 Month 09100041.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\TTP-OLR-M0129
12 Month 1102OS701.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\TTP-OLR-M0129
18 Month 09100041.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\TTP-OLR-M0129
18 Month 1102OS701.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\TTP-OLR-M0129
24 Month 09100041.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\04_M0129\TTP-OLR-M0129
24 Month 1102OS701.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\M0131
TCR.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
00-Month OSI678.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
00-Month OSI940.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
01-Month Correspondence Record.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
01-Month OSI678.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
01-Month OSI940.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
01-Month OSI940-2.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
02-Month OSI678.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
02-Month OSI678-2.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
02-Month OSI678-3.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
02-Month OSI940.pdf

 

     

     

    

  

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
02-Month OSI940-2.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
02-Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
03-Month 8196CM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
03-Months 65096DM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
03-Months BRP-D-86.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
03-Months GMR-B-103.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
03-Months OSIP692940 08196CM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
03-Months OSIP692940 IN-GMR-B-103.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
03-Months OSIP699678 65096DM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
03-Months OSIP699678 IN-BRP-D-86.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
06-Months OSIP692940 08196CM.PDF

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
06-Months OSIP699678 65096DM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
06-Months OSIP699678 IN-BRP-D-86.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
09-Months OSIP692940 08196CM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
09-Months OSIP692940 IN-GMR-B-103.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
09-Months OSIP699678 65096DM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
09-Months OSIP699678 IN-BRP-D-86.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
12-Months OSIP692940 08196CM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
12-Months OSIP692940 IN-GMR-B-103.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
12-Months OSIP699678 65096DM.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\OLR-M0131
12-Months OSIP699678 IN-BRP-D-86.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\PR
341620.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\05_M0131\PR
345917.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\3M
data correction.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\DSC
for TTP-OLR-M0134 photo.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\DSC
OLR-M0134 6 month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\DSC
OLR-M0134 6M at 5°C - initial for new instrument.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\OLR-M0134
6M 40-75 XRPD.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\OLR-M0134
DSC 00 month versus 06 month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\OLR-M0134
In.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\RPT-A-OLR-M0134-00
Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\RPT-A-OLR-M0134-01
Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\RPT-A-OLR-M0134-03
Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\RPT-A-OLR-M0134-06
Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\RPT-A-OLR-M0134-09
Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\RPT-A-OLR-M0134-12
Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\RPT-A-OLR-M0134-18
Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\06_M0134\TTP-OLR-M0134
24 Month COAs.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\07_M0137\RPT-A-OLR-M0137
Cycle 0.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\07_M0137\RPT-A-OLR-M0137
Cycle 1.pdf

 

     

     

    

  

10_Stability\03_Stability Data\01_API\01_Catalent\07_M0137\RPT-A-OLR-M0137
Cycle 2-3.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\08_M0146\121439
Particle Size initial.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\08_M0146\BR
linkage to AMRI lot no.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\08_M0146\Date
of micronization and batch yield.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\08_M0146\OLR_M0146
9 Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\08_M0146\OLR-M0146
01M.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\08_M0146\OLR-M0146
3 Month.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\08_M0146\OLR-M0146
Initial.pdf

10_Stability\03_Stability Data\01_API\01_Catalent\08_M0146\OLR-M0146_
6 month_COA.PDF

10_Stability\03_Stability Data\01_API\02_CML DATA\OSI-027RP
TTP-OLR-M0090 CMLW-243-07-OS3 3M.pdf

10_Stability\03_Stability Data\01_API\02_CML DATA\OSI-027RP
TTP-OLR-M0090 CMLW-243-07-OS3 6M.pdf

10_Stability\03_Stability Data\01_API\02_CML DATA\OSI-027RP
TTP-OLR-M0090 CMLW-243-07-OS3 Initial.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap 13803.001A 1-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap 13803.001A 3-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap 13803.001A 6-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap 13803.001A 9-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap 13803.002A 3-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap OSP07-0020-1 F-2484-021 1-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap OSP07-0020-1 F-2484-021 3-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap OSP07-0020-1 F-2484-021 6-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
20mg cap OSP07-0020-1 F-2484-021 9-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap 13802.001A 1-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap 13802.001A 3-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap 13802.001A 6-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap 13802.001A 9-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap 13802.002A 3-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap OSP07-0019-1 F-2484-019B 1-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap OSP07-0019-1 F-2484-019B 3-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap OSP07-0019-1 F-2484-019B 6-Month.pdf

10_Stability\03_Stability Data\02_Capsules\01_OSI pdfs\OSI-027RP
5mg cap OSP07-0019-1 F-2484-019B 9-Month.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 100mg OSI2C100MG0101 00M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 100mg OSI2C100MG0101 01M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 100mg OSI2C100MG0101 02M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 100mg OSI2C100MG0101 03M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 100mg OSI2C100MG0101 06M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 5mg OSI2C5MG0201 00M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 5mg OSI2C5MG0201 01M.pdf

 

     

     

    

  

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 5mg OSI2C5MG0201 02M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 5mg OSI2C5MG0201 03M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\01_2nd
Generation\OSI-027RP Capsules, 5mg OSI2C5MG0201 06M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\02_OOS
Reports\OSI-SP-048-0109_M18_UR29141.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\02_OOS
Reports\OSI-SP-059-0409_M36_UR33193.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps 20 mg (HBVC) 12 month.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 00M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 01M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 03M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 03M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 06M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 06M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 09M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 12M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 18M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 24M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (C1640A001) 48M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (HBVC) 00M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (HBVC) Release.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 00M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 01M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 02M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 03M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 03M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 06M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 06M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 09M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 12M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 18M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 24M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20 mg (OSIC0200101) 48M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 200 mg (OSIC0200101) 60M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.001A) 15M int.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.001A) 15M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.001A) 18M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.001A) 24M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.001A) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.001A) 48M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.001A) 60M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.001A) 6M acc retest.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.002A) 11M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.002A) 12M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.002A) 18M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.002A) 36M.pdf

 

     

     

    

  

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.002A) 48M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (13803.002A) 60M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (F-2484-021) 17M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (F-2484-021) 24M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 20mg (F-2484-021) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 00M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 01M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 03M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 03M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 06M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 06M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 09M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 12M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 18M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 24M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (C1639A001) 48M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 00M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 01M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 02M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 03M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 03M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 06M acc.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 06M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 09M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 12M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 18M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 24M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 48M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5 mg (OSIC0050101) 60M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.001A) 15M int.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.001A) 15M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.001A) 18M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.001A) 24M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.001A) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.001A) 48M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.001A) 60M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.001A) 6M acc retest.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.002A) 11M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.002A) 12M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.002A) 18M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.002A) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.002A) 48M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (13802.002A) 60M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (F-2484-019B) 17M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (F-2484-019B) 24M.pdf

10_Stability\03_Stability Data\02_Capsules\02_Patheon Data\OSI-027RP
Caps, 5mg (F-2484-019B) 36M.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-1m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-1m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-1m-5c.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-1m-all disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-2m-4075 disso.pdf

 

     

     

    

  

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-2m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-3m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-3m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-3m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-3m-disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-6m-2560 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-6m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-6m-3065 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-6m-3065.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-6m-4075 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-6m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-6m-5 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-6m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-9m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-9m-3065.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\01_13802-001
- 5mg\13802.001A-30perpack-9m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\02_13802-002
- 5mg\13802 002A-30perpack-6m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\02_13802-002
- 5mg\13802 002A-30perpack-6m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\02_13802-002
- 5mg\13802.002A 3M-2560 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\02_13802-002
- 5mg\13802.002A CofA.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\02_13802-002
- 5mg\13802.002A initial disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\02_13802-002
- 5mg\13802.002A-30perpack-3m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001a-30perpack-1m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-1m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-1m-5c.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-1m-all disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-2m-4075 disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-2m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-3m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-3m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-3m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-3m-disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-6m-2560 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-6m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-6m-3065 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-6m-3065.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-6m-4075 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-6m-4075.pdf

 

     

     

    

  

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-6m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-6m-5c Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-9m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-9m-3065.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\03_13803-001
- 20mg\13803.001A-30perpack-9m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\04_13803-002
- 20mg\13803 002A-30perpack-6m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\04_13803-002
- 20mg\13803 002A-30perpack-6m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\04_13803-002
- 20mg\13803.002A initial disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\04_13803-002
- 20mg\13803.002A 3M@25-60 Disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\04_13803-002
- 20mg\13803.002A 3M@25-60.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\04_13803-002
- 20mg\13803.002A CofA.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\04_13803-002
- 20mg\13803.002A-30perpack-3m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B 3M Original S1 Dissolution data.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30package-2m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-12m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-12m-3065.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-12m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-1m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-1m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-1m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-1m-5_rev.1.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-1m-Freezer.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-2m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-3m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-3m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-3m-5c.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-6m-2560 disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-6m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-6m-4075 disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-6m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-6m-5 disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-6m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-7weeks-2560.pdf

 

     

     

    

  

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-7weeks-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-7weeks-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-9m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-30perpack-9m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-Initial.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-Initial_rev.1.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\05_F2484-019B
- 5mg\F-2484-019B-TR07-1915_DP_rev.1.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021 3M Original S1 Dissolution data.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-12m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-12m-3065.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-12m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-1m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-1m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-1m-5c.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-1m-Freezer.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-2m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-3m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-3m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-3m-5c.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-6m-2560 disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-6m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-6m-4075 disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-6m-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-6m-5 disso.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-6m-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-7weeks-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-7weeks-4075.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-7weeks-5.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-30perpack-9m-2560.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-Initial.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\06_F-2484-021
- 20mg\F-2484-021-Initial_rev.1.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\07_LIRs\INV08-0166
Pii 6M 4075 lot 13802.001A\13802.001A form to start 30-65.pdf

 

     

     

    

  

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\07_LIRs\INV08-0166
Pii 6M 4075 lot 13802.001A\Final Investigation documents.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\07_LIRs\INV08-0166
Pii 6M 4075 lot 13802.001A\OSI-027 bulk density.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\07_LIRs\INV08-0166
Pii 6M 4075 lot 13802.001A\TM 07-0256.01 May 2008.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\07_LIRs\LIR
08-0049 for wrong KF method at 2M.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\07_LIRs\LIR
08-0128 for wrong KF method at 6M.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\07_LIRs\OSI
QA Letter to Pii for LIR 08-0128 for wrong KF method at 6M.pdf

10_Stability\03_Stability Data\02_Capsules\03_Pii Data\Pii data
summary for IMPD.pdf

10_Stability\03_Stability Data\02_Capsules\Pages from OSI-027RP
Caps, 20mg (13803.002A) 48M for OOS investigation.pdf

10_Stability\03_Stability Data\02_Capsules\Pages from OSI-027RP
Caps, 5mg (13802.002A) 48M for OOS investigation.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100 mg OSI2T100MG1701 18M blisters.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100 mg OSI2T100MG1701 18M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg HSNX - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg HSNX 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg HSNX 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg HSNX 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg HSNX 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg HSNX 12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0501 - Initial.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0501 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0501 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0501 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0501 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0501 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0601 - 6M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0601 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0601 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0601 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0601 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0601 -Initial.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0701 - 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0701 - Initial.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0701 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0701 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0701 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0701 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0701 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0801 - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0801 - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0801 - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0801 - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG0801 - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 00M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 01M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 02M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 02W open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 03M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 03M.pdf

 

     

     

    

 

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - 12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - BLIS - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - BLIS - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - BLIS - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - BLIS - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - BLIS - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701 - BLIS - 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
100mg OSI2T100MG1701-BLIS-12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0101 - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0101 - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0101 - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0101 - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0101 - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0201 - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0201 - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0201 - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0201 - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
120mg OSI2T120MG0201 - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20 mg HSNT 12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20 mg OSI2T20MG0201 18M blisters.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20 mg OSI2T20MG0201 18M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg HSNT - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg HSNT - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg HSNT - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg HSNT - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg HSNT - 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0101 - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0101 - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0101 - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0101 - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0101 - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 00M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 01M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 02M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 02W open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 03M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - 12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - BLIS - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - BLIS - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - BLIS - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - BLIS - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - BLIS - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201 - BLIS - 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
20mg OSI2T20MG0201-BLIS-12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50 mg HSNV 12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50 mg OSI2T50MG0101 18M blisters.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50 mg OSI2T50MG0101 18M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg HSNV - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg HSNV - 01M.pdf

 

     

     

    

  

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg HSNV - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg HSNV - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg HSNV - 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 00M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 01M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 02M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 02W open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 03M open bottle.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - 12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - BLIS - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - BLIS - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - BLIS - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - BLIS - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - BLIS - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101 - BLIS - 09M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
50mg OSI2T50MG0101-BLIS-12M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0201 - Initial.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0201 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0201 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0201 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0201 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0201 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0301 - 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0301 - 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0301 - 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0301 - 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0301 - 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0401 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0401 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0401 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0401 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0401 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0501 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0501 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0501 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0501 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0501 06M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0601 00M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0601 01M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0601 02M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0601 03M.pdf

10_Stability\03_Stability Data\03_Tablets\OSI-027RP Tablets,
5mg OSI2T5MG0601 06M.pdf

10_Stability\03_Stability Data\03_Tablets\Product Information
for OSI-027RP-Capsules-Tablets_updated_2.pdf

10_Stability\03_Stability Data\03_Tablets\Product Information
for OSI-027RP-FeasibilityBatchInfo_1.pdf

10_Stability\04_Stability Protocols\01_API Comparability milled
vs unmilled\API Comparability milled vs unmilled OSI-027RP.pdf

10_Stability\04_Stability Protocols\01_API Comparability milled
vs unmilled\Comparability protocol OSI-027 micronization Rev.pdf

10_Stability\04_Stability Protocols\01_API Comparability milled
vs unmilled\Interim Comparability Report milled vs unmilled Interim.pdf

 

     

     

    

  

10_Stability\04_Stability Protocols\02_Catalent\OLR M0118.03
approved.PDF

10_Stability\04_Stability Protocols\02_Catalent\OLR M0129.04
approved.PDF

10_Stability\04_Stability Protocols\02_Catalent\OLR M0131.03
approved.PDF

10_Stability\04_Stability Protocols\02_Catalent\OLR M0134.04
approved.PDF

10_Stability\04_Stability Protocols\02_Catalent\TTP-OLR-M0090.08.pdf

10_Stability\04_Stability Protocols\02_Catalent\TTP-OLR-M0095.07.pdf

10_Stability\04_Stability Protocols\02_Catalent\TTP-OLR-M0137.00.pdf

10_Stability\04_Stability Protocols\02_Catalent\TTP-OLR-M0146.00.pdf

10_Stability\04_Stability Protocols\02_Catalent\TTP-OLR-M0149.03.pdf

10_Stability\04_Stability Protocols\03_Comparability Protocol
milled vs unmilled\Comparability protocol OSI-027 micronization.pdf

10_Stability\04_Stability Protocols\03_Comparability Protocol
milled vs unmilled\Revised Comparability protocol OSI-027 micronization.pdf

10_Stability\04_Stability Protocols\04_Patheon\batch details\C1639
and C1640.pdf

10_Stability\04_Stability Protocols\04_Patheon\batch details\OSI-SP-058-0409
Sample Destruction Auth.pdf

10_Stability\04_Stability Protocols\04_Patheon\batch details\OSI-SP-081-1210
Sample Disposition.pdf

10_Stability\04_Stability Protocols\04_Patheon\batch details\OSI-SP-099-0412
batch details.pdf

10_Stability\04_Stability Protocols\04_Patheon\batch details\OSI-SP-099-0412
batch info.pdf

10_Stability\04_Stability Protocols\04_Patheon\batch details\OSI-SP-115-0712-R0
Batch Information.pdf

10_Stability\04_Stability Protocols\04_Patheon\batch details\Repackaging
of OSI-027RP Tablets for Open Bottle Protocol OSI-SP-110-0512.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-041-1208-R1.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-048-0109-R2.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-058-0409-R1
Pii transfer - feasibilty lots.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-059-0409-R2.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-080-1110-R0-
OSI-027RP Prototype Tablets and Capsules.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-081-1210-R1
OSI-027RP Tablet Prototypes 5, 20 and 100 mg.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-087-1211-R0
Prototype OSI-027RP Tablets.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-091-0212-R2.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-099-0412-R0
OSI-027 Capsules CTM .pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-108-0512-R2.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-110-0512-R2.pdf

10_Stability\04_Stability Protocols\04_Patheon\OSI-SP-115-0712-R0.pdf

10_Stability\04_Stability Protocols\05_Pii\OSI letter to Pii
- stability terminations.pdf

10_Stability\04_Stability Protocols\05_Pii\OSP07-0019-1 Lot
F-2484-019B 5mg Capsules.pdf

10_Stability\04_Stability Protocols\05_Pii\OSP07-0020-1 Lot
F-2484-021 20mg Capsules.pdf

10_Stability\04_Stability Protocols\05_Pii\OSP07-0021-1 Lot
13803.001A 20mg Capsules.pdf

10_Stability\04_Stability Protocols\05_Pii\OSP07-0022-1 Lot
13802.001A 5mg Capsules.pdf

10_Stability\04_Stability Protocols\05_Pii\OSP08-0001-1 Lot
13802.002A 5mg Capsules.pdf

10_Stability\04_Stability Protocols\05_Pii\OSP08-0002-1 API
input.pdf

10_Stability\04_Stability Protocols\05_Pii\OSP08-0002-1 Lot
13803.002A 20mg Capsules.pdf

10_Stability\05_Stability Reports\01_027 api extension\API requirements
- client memo API transport LTR 19-Jan-2012 .pdf

10_Stability\05_Stability Reports\01_027 api extension\API Transportation
Patheon LTR 25-Oct-2011.PDF

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Micronized Retest date ext to 9M.pdf

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Retest (36M) to AMRI SAFC.pdf

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Retest 36M.pdf

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Retest 48M (CMLW-469-08-OS3 only).pdf

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Retest date ext to 12M.pdf

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Retest date ext to 24M.pdf

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Retest date ext to 36M.pdf

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Retest date ext to 48M (CMLW-469-08-OS3 only).pdf

 

     

     

    

 

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP
API Retest date ext to 9M.pdf

10_Stability\05_Stability Reports\01_027 api extension\OSI-027RP-006
API Re-evaluation 36M.pdf

10_Stability\05_Stability Reports\01_027 api extension\RE-Eval
date Justification form drug substance OSI027RP-001.pdf

10_Stability\05_Stability Reports\01_027 api extension\stability
extension form OSI-027RP-006 36-months.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules Expiry 60M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 12M Final.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 15M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 24M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 36M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 48M QA approval.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 48M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 48M_Updated Lot Numbers 01 Aug 2011.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 60M form.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 60M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules extension to 9M Final.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Capsules no change to 12M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Tablet extension to 18M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Tablet extension to 24M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP
Tablets Open Bottle summary.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP-003
Tablets expiry form 9M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP-004
Tablets expiry form 12M.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP-005
tablet re-eval justification 11 jan 2013.pdf

10_Stability\05_Stability Reports\02_027 dp extension\OSI-027RP-007
Tablets expiry form 24M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\1-1-OSI-027RP 5mg cap OSIC0050101 48M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\1-2-OSI-027RP 5mg cap OSIC0050101 06M acc.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\2-1-OSI-027RP 20mg cap OSIC0200101 48M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\2-2-OSI-027RP 20mg cap OSIC0200101 06M acc.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\3-1-OSI-027RP 5mg cap C1639A001 36M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\3-1-OSI-027RP 5mg cap C1639A001 48M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\3-2-OSI-027RP 5mg cap C1639A001 06M acc.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\4-1-OSI-027RP 20mg cap, C1640A001 36M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\4-1-OSI-027RP 20mg cap, C1640A001 48M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\4-2-OSI-027RP 20mg cap, C1640A001 06M acc.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\01_Capsules
- G1\5-1-OSI-027RP 20mg cap, HBVC 00M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\02_Capsules
- G2\1-OSI-027RP 5mg cap G2 OSI2C5MG0201 06M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\02_Capsules
- G2\2-OSI-027RP 100mg cap G2 OSI2C100MG0101 6M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\03_Tablets
- G1\1-OSI-027RP 5mg tab G1 OSI2T5MG0201 06M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\03_Tablets
- G1\2-OSI-027RP 100mg tab G1 OSI2T100MG0501 06M.pdf

 

     

     

    

  

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\03_Tablets
- G1\3-OSI-027RP 100mg tab G1 OSI2T100MG0601 06M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\03_Tablets
- G1\4-OSI-027RP 100mg tab G1 OSI2T100MG0701 06M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\01-1-OSI-027RP 5mg tab G2 OSI2T5MG0301 06M 25-60.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\01-2-OSI-027RP 5mg tab G2 OSI2T5MG0301 06M 30-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\01-3-OSI-027RP 5mg tab G2 OSI2T5MG0301 06M 40-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\02-1-OSI-027RP 20mg tab G2 OSI2T20MG0101 06M 25-60.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\02-2-OSI-027RP 20mg tab G2 OSI2T20MG0101 06M 30-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\02-3-OSI-027RP 20mg tab G2 OSI2T20MG0101 06M 40-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\03-1-OSI-027RP 100mg tab G2 OSI2T100MG0801 06M 25-60.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\03-2-OSI-027RP 100mg tab G2 OSI2T100MG0801 06M 30-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\03-3-OSI-027RP 100mg tab G2 OSI2T100MG0801 06M 40-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\04-1-OSI-027RP 5mg tab G2 OSI2T5MG0401 06M 40-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\05-1-OSI-027RP 5mg tab G2 OSI2T5MG0501 06M 40-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\06-1-OSI-027RP 5mg tab G2 OSI2T5MG0601 06M 40-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\07-1-OSI-027RP 120mg tab G2 OSI2T120MG0101 06M 40-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\04_Tablets
- G2\08-1-OSI-027RP 120mg tab G2 OSI2T120MG0201 06M 40-75.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\05-1-OSI-027RP 20mg tab OS2T20mg0201 (bottles) 12M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\05-2-OSI-027RP 20mg tab OS2T20mg0201 (bottles) 06M 4075.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\05-3-OSI-027RP 20mg tab OS2T20mg0201 (blisters) 06M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\05-3-OSI-027RP 20mg tab OS2T20mg0201 (blisters) 09M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\05-4-OSI-027RP 20mg tab OS2T20mg0201 (blisters) 06M 4075.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\05-5-OSI-027RP 20mg tab OS2T20mg0201 (open bottle) 03M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\06-1-OSI-027RP 50mg tab OS2T50mg0101 (bottles) 12M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\06-2-OSI-027RP 50mg tab OS2T50mg0101 (bottles) 06M 4075.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\06-3-OSI-027RP 50mg tabs OSI2T50mg0101 (blisters) 06M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\06-3-OSI-027RP 50mg tabs OSI2T50mg0101 (blisters) 09M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\06-4-OSI-027RP 50mg tab OS2T50mg0101 (blisters) 06M 4075.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\06-5-OSI-027RP 50mg tab OS2T50mg0101 (open bottle) 03M.pdf

 

     

     

    

 

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\07-1-OSI-027RP 100mg tab OS2T100MG1701 (bottles) 12M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\07-3-OSI-027RP 100mg tab OS2T100MG1701 (blisters) 06M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\07-3-OSI-027RP 100mg tab OS2T100MG1701 (blisters) 09M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\07-5-OSI-027RP 100mg tab OS2T100MG1701 (open bottle) 03M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\08-1-OSI-027RP 20mg tab HSNT (bottles) 09M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\08-2-OSI-027RP 20mg tab HSNT (bottles) 06M 4075.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\09-1-OSI-027RP 50mg tab HSNV (bottles) 09M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\09-2-OSI-027RP 50mg tab HSNV (bottles) 06M 4075.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\10-1-OSI-027RP 100mg tab HSNX (bottles) 09M.pdf

10_Stability\05_Stability Reports\03_Drug Product\01_Patheon\05_Tablets
(CTM)\10-2-OSI-027RP 100mg tabs HSNX (bottles) 06M 4075.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\027
docs for OOS 6 month 40C-75RH.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\1-1-OSI-027RP
5mg cap F-2484-019B 36M.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\1-2-OSI-027RP
5mg cap F-2484-019B 6M acc.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\2-1-OSI-027RP
20mg cap F-2484-021 36M.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\2-2-OSI-027RP
20mg cap F-2484-021 6M acc.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\3-1-OSI-027RP
5mg cap 13802.001A 60M.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\3-2-OSI-027RP
5mg cap 13802.001A 15M int.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\3-3-OSI-027RP
5mg cap 13802.001A 6M acc retest.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\4-1-OSI-027RP
20mg cap 13803.001A 60M.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\4-2-OSI-027RP
20mg cap 13803.001A 15M int.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\4-3-OSI-027RP
20mg cap 13803.001A 6M acc retest.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\5-OSI-027RP
5mg cap 13802.002A 60M.pdf

10_Stability\05_Stability Reports\03_Drug Product\02_Pii\6-OSI-027RP
20mg cap 13803.002A 60M.pdf

10_Stability\05_Stability Reports\04_Drug Substance\1-1-OSI-027RP
CML-W-243-07-OS3 60M.pdf

10_Stability\05_Stability Reports\04_Drug Substance\1-2-OSI-027RP
CML-W-243-07-OS3 6M acc.pdf

10_Stability\05_Stability Reports\04_Drug Substance\2-OSI-027RP
CML-W-076-08-OS4 60M.pdf

10_Stability\05_Stability Reports\04_Drug Substance\3-1-OSI-027RP
1008391022 24M.pdf

10_Stability\05_Stability Reports\04_Drug Substance\3-2-OSI-027RP
1008391022 6M Acc.pdf

10_Stability\05_Stability Reports\04_Drug Substance\4-1-OSI-027RP
1102OS701 24M 2560.pdf

10_Stability\05_Stability Reports\04_Drug Substance\4-2-OSI-027RP
1102OS701 06M ACC.pdf

10_Stability\05_Stability Reports\04_Drug Substance\5-1-OSI-027RP
09100041 24M 2560.pdf

10_Stability\05_Stability Reports\04_Drug Substance\5-2-OSI-027RP
09100041 06M ACC.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\1-1-OSI-027RP
111363 12M 2560.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\1-2-OSI-027RP
111363 03M 3065.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\1-3-OSI-027RP
111363 06M 4075.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\1-4-OSI-027RP
111363 Photostability.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\1-5-OSI-027RP
111363 Thermal Cycling C3.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\2-1-OSI-027RP
111364 12M 2560.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\2-2-OSI-027RP
111364 03M 3065.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\2-3-OSI-027RP
111364 06M 4075.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\2-4-OSI-027RP
111364 Photostability.pdf

10_Stability\05_Stability Reports\04_Drug Substance\Micronized\3-1-OSI-027RP
121439 00M 2560.pdf

10_Stability\05_Stability Reports\05_Starting Materials\1-1-OSIP699678
65096DM 12M 5C.pdf

10_Stability\05_Stability Reports\05_Starting Materials\1-2-OSIP699678
65096DM 12M 25-60.pdf

10_Stability\05_Stability Reports\05_Starting Materials\1-3-OSIP699678
65096DM 06M 40-75.pdf

10_Stability\05_Stability Reports\05_Starting Materials\2-1-OSIP699678
IN-BRP-D-86 12M 5C.pdf

 

     

     

    

 

10_Stability\05_Stability Reports\05_Starting Materials\2-2-OSIP699678
IN-BRP-D-86 12M 25-60.pdf

10_Stability\05_Stability Reports\05_Starting Materials\2-3-OSIP699678
IN-BRP-D-86 06M 40-75.pdf

10_Stability\05_Stability Reports\05_Starting Materials\3-1-OSIP692940
08196CM 12M 5C.pdf

10_Stability\05_Stability Reports\05_Starting Materials\3-2-OSIP692940
08196CM 12M 25-60.pdf

10_Stability\05_Stability Reports\05_Starting Materials\3-3-OSIP692940
08196CM 06M 40-75.pdf

10_Stability\05_Stability Reports\05_Starting Materials\4-1-OSIP692940
IN-GMR-B-103 12M 5C.pdf

10_Stability\05_Stability Reports\05_Starting Materials\4-2-OSIP692940
IN-GMR-B-103 12M 25-60.pdf

10_Stability\05_Stability Reports\05_Starting Materials\4-3-OSIP692940
IN-GMR-B-103 06M 40-75.pdf

11_Starting Material COAs\030212 Q46924 HPLC Data.pdf

11_Starting Material COAs\OSIP692940 AMRI batch IN-GMR-B-103.pdf

11_Starting Material COAs\OSIP692940 -Lot R10008003.pdf

11_Starting Material COAs\OSIP692940 SAFC batch 08196CM.pdf

11_Starting Material COAs\OSIP692940 SAFC batch 85596MK.pdf

11_Starting Material COAs\OSIP699678 AMRI batch IN-BRP-D-86.pdf

11_Starting Material COAs\OSIP699678 AMRI batch IN-BRP-D-94.pdf

11_Starting Material COAs\OSIP699678 -Lot R10008041.pdf

11_Starting Material COAs\OSIP699678 SAFC batch 34996PK.pdf

11_Starting Material COAs\OSIP699678 SAFC batch 65096DM.pdf

12_Toxicology\01_ADC\01_Protocols\OSI-027RP in DMSO 2067 Validation
Protocol.pdf

12_Toxicology\01_ADC\01_Protocols\OSI-027RP in DMSO Method Qual
Protocol Low dose Jan-2008.pdf

12_Toxicology\01_ADC\02_Reports\2067A-1 for AMS00107 after changes
requested by Study Director.pdf

12_Toxicology\01_ADC\02_Reports\2067L-1 Final Report for Qual
of OSI-027RP in DMSO dose solutions-low conc.pdf

12_Toxicology\01_ADC\02_Reports\ADMEQuant Final Report 2067A-2
for CAB00107.pdf

12_Toxicology\01_ADC\02_Reports\ADMEQUANT Final Report 2067L2
Addendum Devs.pdf

12_Toxicology\01_ADC\02_Reports\OSI-027RP in DMSO Method Qual
Mar 2008 - ADMEQuant.pdf

12_Toxicology\02_protocols\R2007056 MNT amendment 1.pdf

12_Toxicology\02_protocols\R2007056 MNT final protocol.pdf

12_Toxicology\03_Tox Reports\01_Explanatory Memos\Memo for P2007051
Dose Solution Analysis Subreport XSP07-008 final.pdf

12_Toxicology\03_Tox Reports\01_Explanatory Memos\Memo for R2007052
Dose Solution Analysis Subreport XSP07-009 final.pdf

12_Toxicology\03_Tox Reports\01_Explanatory Memos\Memo for R2007053
Dose Solution Analysis Subreport XSP07-010 final.pdf

12_Toxicology\03_Tox Reports\01_Explanatory Memos\Memo for V2007076
Dose Solution Analysis Subreport Chantest 070507.PTJ final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Memo for ChanTest
16-Jul-08.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Memo XSP07-008
frozen stability.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Memo XSP07-009
frozen stability.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Memo XSP07-010
frozen stability.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\P2007041 Dose
Solution Analysis Subreport SNBL.040.08 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\P2007051 Dose
Solution Analysis Subreport XSP07-008 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\P2007074 Dose
Solution Analysis Subreport SNBL.040.09 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\R2007040 Dose
Solution Analysis Subreport PCRS-OSI-0703 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\R2007043 Dose
Solution Analysis Subreport PCRS-OSI-0704 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\R2007052 Dose
Solution Analysis Subreport XSP07-009 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\R2007053 Dose
Solution Analysis Subreport XSP07-010 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\R2007056 Dose
Solution Analysis Subreport MNA00407 final.pdf

 

     

     

    

  

12_Toxicology\03_Tox Reports\02_final tox reports\V2007076 Dose
Solution Analysis Subreport Chantest 070507.PTJ final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan P2007041 SNBL.040.08 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan P2007051 XSP07-008.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan P2007074 SNBL.040.09 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan R2007040 PCRS-OSI-0703 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan R2007043 PCRS-OSI-0704 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan R2007052 XSP07-009 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan R2007053 XSP07-010 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan R2007056 MNA00407 final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\Signature Scan V2007076 070507.PTJ final.pdf

12_Toxicology\03_Tox Reports\02_final tox reports\Tox Rpt Sig
Pages\wrong header Signature Scan P2007051 XSP07-008 final.pdf

12_Toxicology\03_Tox Reports\03_tox gmp letters\P2007041 SNBL.040.08
GMP Letter.jpg

12_Toxicology\03_Tox Reports\03_tox gmp letters\P2007051 XSP07-008
GMP Letter.jpg

12_Toxicology\03_Tox Reports\03_tox gmp letters\P2007074 SNBL.040.09
GMP Letter.jpg

12_Toxicology\03_Tox Reports\03_tox gmp letters\R2007040 PCRS-OSI-0703
GMP Letter.jpg

12_Toxicology\03_Tox Reports\03_tox gmp letters\R2007043 PCRS-OSI-0704
GMP Letter.jpg

12_Toxicology\03_Tox Reports\03_tox gmp letters\R2007052 XSP07-009
GMP Letter.jpg

12_Toxicology\03_Tox Reports\03_tox gmp letters\R2007053 XSP07-010
GMP Letter.jpg

12_Toxicology\03_Tox Reports\03_tox gmp letters\R2007056 MNA00407
GMP Letter.jpg

12_Toxicology\03_Tox Reports\03_tox gmp letters\tox gmp letters.pdf

12_Toxicology\03_Tox Reports\03_tox gmp letters\V2007076 070507.PTJ
GMP Letter.jpg

12_Toxicology\03_Tox Reports\Chantest Sample - Pii Analysis
Tox Solution Summary.pdf

12_Toxicology\03_Tox Reports\Chantest Sample - Pii Analysis
Tox Solution Summary Table.pdf

12_Toxicology\03_Tox Reports\Pii Tox Solution Analysis Summary.pdf

12_Toxicology\03_Tox Reports\V2007076 amendment 1.pdf

 

     

     

    

 

SCHEDULE 2

 

OSI PRODUCT PATENTS

 

(***)

 

(***)

(***)

(***)

(***)

(***)

 

     

     

    

SCHEDULE 3

 

COMPOUND STRUCTURE

 

(***)

 

     

     

    

  

SCHEDULE 4

 

DEVELOPMENT PLAN

 

Aevi plans to expeditiously develop OSI-027
for lymphatic malformations including but not limited to generalized lymphatic anomaly (GLA), Kaposiform lymphatic anomaly (KLA),
Gorham Stoudt Disease and lymphatic anomaly unspecified.  These diseases are congenital, rare & orphan, life threatening
and require systemic treatment.

 

Our first priority is to develop OSI-027
for lymphatic malformations, but we would like to consider development of a topical formulation for congenital venous malformations
at some point in the future.  The reason for this prioritization is that, as noted, lymphatic malformations are life-threatening,
rare and without current approved therapies.  There is the possibility for breakthrough designation in the USA. 

 

While we will initially prioritize development
in the USA, we recognize that these conditions occur worldwide, and we will seek to develop and make them available globally to
the extent possible.

 

We will need a new IND for Lymphatic Malformations
with the Office of Hematology and Oncology Products.  Aevi will seek FDA input and advice prior to filing the IND.  We
can reference the previous IND filed by OSI.  Likewise, we will seek advice from the EMA prior to further development in Europe. 
We will seek a partner for Japanese development and commercialization.

 

We will pursue orphan drug designation
in both USA and Europe based on evolving clinical data.  We will also attempt to develop biomarkers for patient selection
and precision dosing to ensure optimal use of the product, especially in lymphatic anomalies.

 

The following provides an outline of the
proposed development program:

 

		•	Synthesize new GMP batch, requalify API if available

		•	Create oral formulation, and explore feasibility of topical formulation

		•	Request pre-IND meeting from FDA

		•	Conduct long-term preclinical studies to support registration

		•	Finalize protocol design for PK/PD proof-of-concept study

		•	File IND for lymphatic malformations

		•	Conduct PK/PD proof-of-concept study (probably limited to 4 weeks) in US

		•	Conduct biomarker works in parallel

		•	Obtain scientific advice from EMA

		•	If positive, file orphan drug designation, breakthrough status, and PRV eligibility; and agree
to pivotal design with FDA

		•	Conduct pivotal trial

		•	File NDA and MAA

     

     

    

  

 

The proposed development plan is built
upon the following assumptions:

		•	API clinical supplies available for requalification

		–	If clinical supplies not available, GMP API development will add 6-month delay

		•	Juvenile Tox Study required prior to pediatric dosing; study will define an appropriate dose with
good risk/benefit profile

		•	Non clinical studies including Human ADME, Carc Tox, Chronic Tox, and Developmental Tox will be
executed in parallel with clinical program

		•	PK/PD Dose Ranging study in adults will begin with open IND

		–	DDI Study in adults will be conducted in parallel with PK/PD Dose Ranging

		•	Ph 2/3 KLA/GM OL Basket Study to follow PK/PD Study and Juvi Tox

		–	POC on KLA indication can be reached with ~10 patients and will support NDA

		•	FDA will grant Orphan designation and Breakthrough designation for both KLA and LM

		•	One PRV will be granted for either KLA or LM

 

     

     

    

 

SCHEDULE 5 

 

REGULATORY DOCUMENTATION

 

(***)

 

     

     

    

 

SCHEDULE 6

PRESS RELEASE

 

Aevi
Genomic Medicine Enters into Worldwide License Agreement with Astellas to develop and commercialize a novel second generation
mTORC1/2 inhibitor

 

Entering Phase 2 clinical trials for
the treatment of Lymphatic Malformations which include a number of rare and orphan diseases.

 

July XX,
2019 — Aevi Genomic Medicine, Inc. (NASDAQ: GNMX, “Aevi”) today announced it has entered into an exclusive license
agreement with OSI Pharmaceuticals, LLC, an indirect wholly-owned subsidiary of Astellas Pharma Inc. (“Astellas”) for
the worldwide development and commercialization of Astellas’ second generation mTORC1/2 inhibitor, ASP7486 (OSI-027). Aevi’s
initial focus of study with ASP7486 will be for congenital Lymphatic Malformations, which includes a number of rare and orphan
diseases. The mTORC1/2 pathway is believed to be involved in greater than 80% of patients with congenital Lymphatic Malformations.

 

Under the terms of the license agreement,
Aevi will pay Astellas an up-front license fee of $500,000 and Astellas will be eligible to receive milestones payments based upon
the achievement of specified development and regulatory milestones. Upon commercialization, Astellas will be entitled to a tiered,
single-digit royalty on worldwide annual net sales. Aevi will be responsible for all clinical development, manufacturing, and commercialization
activities and costs.

 

Lymphatic Malformations are rare congenital
and potentially life-threatening diseases of the lymphatic system. Some of the diseases involved are Generalized Lymphatic Anomaly
(GLA), Kaposiform lymphangiomatosis (KLA), and Gorham-Stoudt disease (GSD). Most lymphatic
malformations are evident at birth or within the first two years of age. The exact prevalence of lymphatic malformations in the
general population is unknown, but is thought to be approximately 1 in every 4000 live births. There may be as many as 30,000 to
60,000 Americans living with congenital lymphatic malformations. In some cases, the disease may be familial and have a recognizable
genetic cause. In most cases it appears to be sporadic, although genetic mutations are often present.

 

There are currently no approved drug therapies
for these conditions. ASP7486 represents a new targeted therapy that may address the underlying cause in the majority of these
patients.

 

"We are delighted to enter into this
agreement with a world class company like Astellas," said Mike Cola, Chief Executive Officer Aevi. "We believe that the
mTOR pathway is a promising novel target with clinical proof of concept that may benefit many children and adults with these potentially
devastating diseases. Entry into this license agreement highlights the broad potential of our unique R&D capabilities and further
supports Aevi’s strategy to rapidly bring novel and life altering therapies to children and adults suffering from rare and
life-threatening orphan diseases.

 

     

     

    

  

About Aevi Genomic Medicine, Inc.

Aevi Genomic Medicine, Inc. is dedicated
to unlocking the potential of genomic medicine to translate genetic discoveries into novel therapies. Driven by a commitment to
patients with pediatric onset life-altering diseases, the company’s research and development efforts leverage an internal
genomics platform and an ongoing collaboration with the Center for Applied Genomics (CAG) at The Children’s Hospital of Philadelphia
(CHOP).

 

Forward-looking Statements

This release contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that
term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of
historical fact, including (without limitation) those regarding the Company's financial position, its development and business
strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such
forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified
by their use of the terms and phrases such as "estimate," "project," "intend," "forecast,"
"anticipate," "plan," "planning, "expect," "believe," "will," "will
likely," "should," "could," "would," "may" or the negative of such terms and other
comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties.
Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results
may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed
on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking
to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's
expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As
a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

 

CONTACT: 

Aevi Genomic Medicine, Inc.

Mike Cola

Mike.cola@aevigenomics.com

 

Westwicke Partners

Chris Brinzey

+1-339-970-2843

Chris.brinzey@westwicke.com

 

MEDIA INQUIRIES:

FTI Consulting

Irma Gomez-Dib

+1-212-850-5761

+1-415-706-9155

irma.gomez-dib@fticonsulting.com

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