Document:

Exhibit

Exhibit 10.31.1

AMENDMENT NO. 1 TO LICENSE AND SUPPLY AGREEMENT

This Amendment No. 1 to that certain License and Supply Agreement (this “Amendment”) is entered into as of March 28, 2008, by and among Novartis AG, Novartis Consumer Health, Inc. (collectively, “Novartis”) and Endo Pharmaceuticals Inc. (“Endo”).

WHEREAS, the Parties entered into a License and Supply Agreement on March 4, 2008 (the “License Agreement”); and

WHEREAS, the terms and conditions in the License Agreement continue to be in full force and effect between the Parties except as modified as set forth below; 

NOW THEREFORE, in consideration of the premises and covenants herein contained the Parties agree as follows:

		
	1.
	The Terms used but not defined herein shall have the meanings set forth in the License Agreement.

		
	2.
	Exclusive Negotiating Period for Line Extensions.  Novartis hereby agrees that the ninety (90) day exclusive negotiation period for a license to Line Extensions referred to in Section 10.1(b) of the License Agreement will not commence until the delivery to Endo of both Novartis’ proposal relating thereto and information reasonably necessary for Endo to evaluate such opportunity.

		
	3.
	Manufacture and Supply.

(a) The Parties hereby agree that, effective as of the Execution Date, Novartis AG shall be substituted for Novartis as a party to Sections 5.1-5.11 of the License Agreement.
(b) During the period from the Execution Date through March 31, 2008 (“Q1 2008”), all purchases of Licensed Product under Section 5 of the License Agreement shall be made by Endo, and for all periods thereafter during the Term of the License Agreement until the Parties otherwise agree, all purchases of Licensed Product under Section 5 of the License Agreement shall be made by Endo Pharma Ireland Limited or another subsidiary identified by Endo to Novartis in writing (any such party, “Endo Sub”).  For purposes thereof, Endo Sub is hereby made a party to Section 5 of the License Agreement and shall have all the rights and obligations of Endo with respect thereto.
(c) Upon execution of this Amendment, Endo shall issue purchase orders for the Licensed Product listed on Annex A to this Amendment.  Upon Novartis’s acceptance and invoicing of such purchase orders and only if such acceptance and invoicing occurs prior to March 31, 2008, all ownership, title and risk of loss of such Licensed Product shall belong to Endo prior to March 31, 2008, it being understood that 

1

Exhibit 10.31.1

Novartis attributes sales to a reporting period under the Medicaid Drug Rebate Program, as codified at 42 U.S.C. § 1396r-8, based on the invoice date of the sale.

(d) The Parties hereby agree that Section 5.4(a) and (e) of the License Agreement shall not apply until July 1, 2008 and that Section 5.13 of the License Agreement shall not apply until October 31, 2008. 

		
	4.
	Price Reporting and Related Government Contracting.

(a) For Q1 2008, with respect to the Licensed Product Novartis shall be solely responsible for (1) calculating and reporting prices for Licensed Product under the Medicaid Drug Rebate Program, as codified at 42 U.S.C. § 1396r-8, including making all decisions with respect thereto, in its discretion, and (2) providing any related certifications to applicable Government Authorities, and (3) reporting and compliance with all state law requirements regarding price disclosure and reporting.  Novartis shall inform Endo of all decisions and actions taken pursuant to the prior sentence prior to taking such decisions and/or actions.  For Q2 2008 and all periods thereafter during the Term of the License Agreement, with respect to the Licensed Product Endo shall be solely responsible for (1) calculating and reporting prices for Licensed Product under the Medicaid Drug Rebate Program, including making all decisions with respect thereto, in its discretion, and (2) providing any related certifications to applicable Government Authorities, and (3) reporting and compliance with all state law requirements regarding price disclosure and reporting.  Endo’s responsibilities as of Q2 2008 shall apply to Licensed Product without regard to whether Licensed Product bears the National Drug Code of Novartis or Endo.  Neither Party shall have any responsibility or liability for decisions made or actions taken by the other Party under this paragraph.  The Parties shall discuss whether to jointly submit a letter to the U.S. Centers for Medicare and Medicaid Services outlining the Parties’ approach to the calculation and reporting of prices under the Medicaid Drug Rebate Program as to Licensed Product and allocation of responsibility set forth herein and if agreed by the Parties, shall submit such letter no later than June 30, 2008; it being understood that no Party shall submit a letter or other correspondence to the U.S. Centers for Medicare and Medicaid Services or similar Governmental Authority regarding the Licensed Product without the prior written consent of the other.  Each Party shall supply to the other Party with any information reasonably requested by the other Party that the other Party needs to perform its responsibilities under this paragraph.

(b) CMS DDR Price Reporting.  The applicable Novartis representative will be responsible for establishing within the Centers for Medicare & Medicaid Services (“CMS”) database the Licensed Product bearing the Novartis labeler code 0067.  Effective with the April 2008 monthly Average Manufacturer’s Price (“AMP”) filing and thereafter, Novartis will transfer reporting responsibility to the applicable Endo representative via the CMS Drug Data Reporting (“DDR”) system for the Licensed Product.  Endo will be responsible for establishing within the CMS DDR the Licensed Product bearing an Endo labeler code.

2

Exhibit 10.31.1

(c) Public Health Service (PHS).  Endo shall have responsibility for all aspects of PHS contract pricing for the Licensed Product. 

(d) Federal Supply Schedule (FSS).  Endo shall have responsibility for all aspects of FSS pricing and non-Federal Average Manufacturer Price reporting for the Licensed Product.  Immediately following execution of this Amendment (and no event later than three days following), Novartis will provide to Endo all correspondence related to the Licensed Product occurring between Novartis and any of its affiliates and the Veterans Administration office (VA).

(e) Pricing Compendia.  Endo will be responsible for notifying the various pricing Compendia of the availability of Licensed Product and the Wholesale Acquisition Cost (“WAC”) pricing as established by Endo for the Licensed Product.  The applicable Novartis representative will be included in such notification and will communicate to the Compendia as necessary in order to grant Endo the exclusive right to report and update the information for the Licensed Product.

(f) The provisions of Sections 2.2, 15.1 and 20 of the License Agreement shall apply to this Amendment.  For the purposes of this paragraph (f), the provisions of this Amendment shall be considered covenants and agreements of, or representations and warranties made by, the Parties in the License Agreement. 

(g) Information provided by one Party to the other Party under this paragraph 3 shall constitute “Confidential Information,” as defined in section 1.26 of the License Agreement and the provisions of Section 14 of the License Agreement shall apply to each Party’s treatment of that information.

(h) Notwithstanding Endo’s assumption of all responsibilities relating to calculation and reporting of prices for Licensed Product under the Medicaid Drug Rebate Program effective April 1, 2008, Novartis shall retain the responsibility for processing and paying rebate claims relating to Licensed Product bearing the Novartis labeler code 0067 submitted by the States under the Medicaid Drug Rebate Program for all periods during the Term of the License Agreement.  On a quarterly basis Endo shall reimburse Novartis for Medicaid rebate claims paid by Novartis relating to Licensed Product.  Endo shall pay Novartis within sixty (60) days of Endo’s receipt of an itemization of these Medicaid claims and supporting documentation, including utilization reports.  Novartis shall be solely responsible for any interest incurred as a result of late payments to the States.  Endo shall have the right to initiate a dispute with a State for reasonable cause, and Novartis shall cooperate with any such actions taken by Endo.  

IN WITNESS WHEREOF, NOVARTIS AG, NOVARTIS and ENDO have caused this Amendment to be executed by their duly authorized representatives as of the day and year first above written.

3

Exhibit 10.31.1

	
				
	ENDO PHARMACEUTICALS INC.

	 
	 
	 
	 

	 
	 
	 
	 

	By:
	/s/
	CHARLES A. ROWLAND, JR.
	 

	Name:
	Charles A. Rowland, Jr.
	 

	Title:
	EVP, CFO & Treasurer
	 

	 
	 
	 
	 

	 
	 
	 
	 

	NOVARTIS AG

	 
	 
	 
	 

	 
	 
	 
	 

	By:
	/s/
	PAUL DAVID BURNS
	 

	Name:
	Paul David Burns 
	 

	Title:
	Authorized Signatory 
	 

	 
	 
	 
	 

	 
	 
	 
	 

	By:
	/s/
	PETER RUPPRECHT
	 

	Name:
	Peter Rupprecht
	 

	Title:
	Authorized Signatory 
	 

	 
	 
	 
	 

	 
	 
	 
	 

	NOVARTIS CONSUMER HEALTH, INC.

	 
	 
	 
	 

	 
	 
	 
	 

	By:
	/s/
	JOHN COWLES
	 

	Name:
	John Cowles
	 

	Title:
	SVP, GM NCH OTC
	 

4Exhibit

Exhibit 10.31.2

AMENDMENT NO. 2 TO LICENSE AND SUPPLY AGREEMENT
This Amendment No. 2 to License and Supply Agreement (this “Amendment”) is entered into with effect as of December 31, 2012 (“Amendment Effective Date”), by and among Endo Pharmaceuticals Inc., a Delaware corporation having a principal place of business at 100 Endo Drive, Chadds Ford, Pennsylvania 19317 (“Endo”), Novartis Consumer Health, Inc., a Delaware corporation having a principal place of business at 200 Kimball Drive, Parsippany, New Jersey 07054 (“Novartis”), and Novartis AG, a Swiss corporation having a principal place of business in Basel, Switzerland (“Novartis AG”).  Each of Novartis AG, Novartis and Endo is referred to herein individually as a “Party” and collectively as the “Parties.”
WHEREAS, the Parties entered into a License and Supply Agreement, dated March 4, 2008, which was amended by that certain Amendment No. 1 to License and Supply Agreement, dated March 28, 2008 (as amended, the “License and Supply Agreement”); 
WHEREAS, the Parties desire to amend the License and Supply Agreement as provided herein; 
WHEREAS, the terms and conditions in the License and Supply Agreement continue to be in full force and effect between the Parties except as modified as set forth below; 
NOW THEREFORE, in consideration of the premises and covenants herein contained the Parties agree as follows:
1.Defined Terms.  Capitalized terms used but not defined herein shall have the meanings set forth in the License and Supply Agreement.    All amendments set forth herein shall become effective prospectively from and after the Amendment Effective Date, unless otherwise expressly provided herein.

2.Amendment to Section 4.4(b).  The table in Section 4.4(b) of the License and Supply Agreement shall be amended and restated to read as follows:  
	
			
	Agreement Year
	Details
	Portion of Details
Required to be Primary
Details

	Year 1
	650,000
	650,000

	Year 2
	650,000
	520,000

	Year 3
	650,000
	520,000

	Year 4
	650,000
	455,000

	Year 5
	390,000
	273,000

	Each Renewal Term
	390,000
	195,000

3.Amendment to Section 4.9.  The table in Section 4.9 of the License and Supply Agreement shall be amended and restated to read as set forth below.  The following sentence shall be added to 

Exhibit 10.31.2

the end of Section 4.9 of the License and Supply Agreement:  “Notwithstanding anything herein to the contrary, in Agreement Year 5 and each Renewal Term thereafter until NOVARTIS notifies ENDO in writing of its abandonment of the OTC Equivalent Product registration application, ENDO’s annual minimum expenditures of A&P Expenses as set forth in Column 5 of the table in this Section 4.9 shall be reduced by twenty percent (20%) from the levels set forth in Column 5.”  
	
					
	Minimum A&P Expenses Requirements

	Column 1
	Column 2
	Column 3
	Column 4
	Column 5

	Agreement
Year 1
	Agreement
Year 2
	Agreement
Year 3
	Agreement
Year 4
	Agreement
Year 5 and Renewal Terms

	$15,000,000
	$20,000,000
	15% of prior Agreement
Year’s Net Sales but not to exceed $30,000,000
	13% of prior Agreement Year’s Net Sales but not to exceed $30,000,000
	4.8% of prior Agreement
Year’s Net Sales
but not to exceed
$30,000,000

4.Amendment to Section 5.9(b).  The following sentence shall be added to the end of Section 5.9(b)(i) of the License and Supply Agreement:  
“Notwithstanding anything herein to the contrary, effective January 1, 2013, the price for Licensed Product shall be reduced by five percent (5%), which shall translate into a reduction of $.24/unit for the 100g tube (currently priced at $4.82/unit) and a reduction of $.06/unit on the 20g tube (currently priced at $1.20/unit); it being understood that this price reduction shall remain in effect throughout the Term of this Agreement.  In the event of any future price increases, the foregoing amounts ($.24/unit for 100g tube and $.06/unit for 20g tube) shall be deducted from the total price otherwise permitted to be charged under the current License and Supply Agreement.”
5.Amendment to Section 9.1.  The last three sentences of Section 9.1 of the License and Supply Agreement are hereby amended and restated to read as follows:
“ENDO shall cooperate fully with NOVARTIS in connection with an OTC Switch, including, providing any materials reasonably required by NOVARTIS to support the OTC Switch.  Notwithstanding the foregoing, NOVARTIS shall not Launch an OTC Equivalent Product prior to April 1, 2014, and NOVARTIS shall not take any action that results in the loss of Rx Product status for the Licensed Product prior to such time. NOVARTIS shall notify ENDO when it submits a filing to the FDA in respect of an OTC Equivalent Product.”
6.Amendment to Section 17.1(a).  The following clause shall be added to the end of the last sentence in Section 17.1(a) of the License and Supply Agreement:  “; provided that notwithstanding the foregoing, in no event shall the NOVARTIS Parties provide notice of non-renewal prior to January 1, 2016.”  For the avoidance of doubt, nothing in this Amendment shall amend or restate, 

Exhibit 10.31.2

or be deemed to amend or restate, any provision of Section 17.2 or Section 17.3 of the License and Supply Agreement or limit the rights of a NOVARTIS Party to terminate the License and Supply Agreement pursuant to Section 17.2 or Section 17.3 of the License and Supply Agreement. 
7.Conflict.  This Amendment will govern if it conflicts with any provision of the License and Supply Agreement. 
8.Effectiveness of the Agreement.  The Parties acknowledge and agree that this Amendment constitutes a valid and binding amendment to the License and Supply Agreement for purposes of Section 20.6 of the License and Supply Agreement.  For the avoidance of doubt, nothing in this Amendment shall be deemed to amend, modify, delete or extend the disclaimers of warranties in Section 13.4 of the License and Supply Agreement or limitations of damages in Section 20.16 of the License and Supple Agreement, which disclaimers and limitations shall apply to this Amendment as if set forth in full herein.  This Amendment may be executed in several counterparts, each of which shall be deemed an original and all of which taken together shall constitute a single instrument.  Except as set forth in this Amendment, there are no other amendments to the License and Supply Agreement and the License and Supply Agreement remains in full force and effect as amended as of the Amendment Effective Date.
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Exhibit 10.31.2

IN WITNESS WHEREOF, this Amendment No. 2 to License and Supply Agreement has been executed by the authorized officers of the Parties hereto with effect as of the Amendment Effective Date. 
	
							
	ENDO PHARMACEUTICALS INC.
	 
	 
	 

	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	 

	By:
	/s/
	David P. Holveck
	 
	 
	 
	 

	Name:
	David P. Holveck
	 
	 
	 
	 

	Title:
	President & Chief Executive Officer
	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	 

	NOVARTIS AG
	NOVARTIS CONSUMER HEALTH, INC.

	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	 

	By:
	/s/
	Felix R. Ehrat
	 
	By:
	/s/
	Greg Tole

	Name:
	Felix R. Ehrat
	 
	Name:
	Greg Tole

	Title:
	Group General Counsel
	 
	Title:
	General Counsel, OTC

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