exv10w14w1




EXHIBIT 10.14.1




AMENDMENT TO THE

DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT

BETWEEN

WYETH, ACTING THROUGH ITS WYETH CONSUMER HEALTHCARE DIVISION,

AND

IMPAX LABORATORIES, INC.



This Amendment, effective as of the last date of signature appearing below (the “Effective Date”),
to the Development, License and Supply Agreement, dated as of June 1, 2002 and amended by letters
dated November 19, 2002, April 23, 2003 and May 15, 2003, for Loratadine/Pseudoephedrine
Combination Tablets (the “Agreement”) is entered into by and between Wyeth, acting through its
Wyeth Consumer Healthcare Division (hereinafter called “WCH”), and Impax Laboratories, Inc.
(hereinafter called “Impax”).




PURPOSE



WHEREAS, under the Agreement, Impax has agreed to supply Wyeth with D-24 Product (as defined in the
Agreement);



WHEREAS, Impax’s ANDA No. 75-989 seeking FDA approval of D-24 Product was submitted on September
14, 2000 and was accepted for filing by the FDA on September 18, 2000;



WHEREAS, on January 2, 2001, Schering Corporation (“Schering”) commenced an action against Impax in
the United States District Court for the District of New Jersey captioned Schering Corporation v.
Impax Laboratories, Inc., Civil Action No. 01-0009 (JWB) (GDH) (the “Action”), alleging that Impax
infringed and is infringing Schering’s U.S. Patent Nos. 5,314,697 and 4,659,716 through its filing
of ANDA No. 75-989;



WHEREAS, in the Action, Impax answered that it did not infringe Schering’s patents and that those
patents were invalid, and sought a declaration that the D-24 Product did not and would not infringe
Schering’s patents and that those patents were invalid;



WHEREAS, on August 8, 2002, the district court handling the Action entered an order granting
Defendants’ Motion for Summary Judgment with respect to U.S. Patent No. 4,659,716 and ruled that
claims 1 and 3 of that patent were invalid. On August 1, 2003, a panel of the U.S. Court of Appeals
for the Federal Circuit affirmed the lower court’s order concerning U.S. Patent No. 4,659,716. On
August 15, 2003, Schering filed a petition for rehearing and rehearing en banc of that panel
decision which was denied in November 2003;



WHEREAS, Impax and Schering have settled the remaining claims in the Action on mutually agreeable
terms without admission of liability by either, on the terms and subject to the conditions set
forth in the Settlement and License Agreement, dated October 24, 2003, between Impax and Schering
(the “Settlement Agreement”);




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WHEREAS, pursuant to the Settlement Agreement Schering granted Impax the right under the Patent (as
such term is defined in the Settlement Agreement) to have up to two Impax Entities (as such term is
defined in the Settlement Agreement) offer to sell, sell, import, package, and/or distribute Impax
Product (as such term is defined in the Settlement Agreement) manufactured by Impax or an Impax
Affiliate (as such term is defined in the Settlement Agreement); and



WHEREAS, Impax desires to convert the exclusive license granted under the Agreement with respect to
the D-24 Product in the United States, its territories and possessions, to a semi-exclusive license
allowing Impax to authorize one other Impax Entity to offer to sell, sell, import, package, and/or
distribute Impax Product and WCH is willing to agree to such amendment on the terms and subject to
the conditions set forth herein.



NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained
herein and intending to be legally bound hereby, the parties hereby agree as follows:



1. Unless otherwise expressly defined herein, all capitalized terms used herein shall have the same
meaning as defined in the Agreement.



2. Section 1.1 of the Agreement is hereby amended to add the following new definitions:



“1.1.61 ‘Settlement Agreement’ means that certain Settlement Agreement, dated as of October 24,
2003, between IMPAX and Schering Corporation relating to the D-24 Product and the settlement of the
claims raised in Schering Corp. v. Impax Laboratories, Inc., Civil Action No. 01-0520 (D.N.J.).”



“1.1.62 ‘Impax Entity’ has the meaning set forth in the Settlement Agreement.”



“1.1.63 ‘Impax Product’ has the meaning set forth in the Settlement Agreement.”






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3. Section 2.1.1 of the Agreement is amended to read in its entirety as follows:



“2.1.1 IMPAX hereby grants to WCH an exclusive license within the Exclusive Territory and a
semi-exclusive license within the Semi-Exclusive Territory, both with the right to grant
sublicenses, under the IMPAX Patents and IMPAX’s Technical Information and Regulatory Documents, to
market, promote, use, distribute, sell, have sold, import and export Products for the OTC Field
during the Term of this Agreement. WCH shall notify IMPAX in writing prior to having the name of
any Third Party on a Product label. IMPAX hereby agrees that WCH is an Impax Entity within the
meaning of Section 2.1 of the Settlement Agreement, and that WCH may, while acting as an Impax
Entity, offer to sell, sell, import, package and/or distribute the D-24 Product (the “Rights”). WCH
understands that the Settlement Agreement does not authorize WCH, as an Impax Entity, to
manufacture or have manufactured the D-24 Product or to sublicense the Rights. Notwithstanding the
exclusive license set forth above, IMPAX shall be permitted to Manufacture and sell (i) the D-12
Product to Schering Corporation in the United States, its territories and possessions and
(ii) the D-24 Product to one other Impax Entity who is authorized only to offer to sell, sell,
package, and/or distribute D-24 Product in the United States, its territories and possessions in
compliance with the Settlement Agreement.”



4. Section 2.3 of the Agreement is amended to read in its entirety as follows:



“During the Term, IMPAX and its Affiliates shall only sell Product for the OTC Field in the
Exclusive Territory to WCH and shall not market, promote, use, distribute, sell, have sold, import,
export, make or have made either a twelve-hour or twenty-four hour, extended release Loratadine and
Pseudoephedrine combination product (other than the Products) which is, in dosage strength,
identical to either Product (a “Competing Product”) to a Third Party for the OTC Field in the
Exclusive Territory. Notwithstanding the foregoing, IMPAX shall be permitted (i) to Manufacture and
sell D-12 Product to Schering Corporation in the United States, its territories and possessions;
(ii) to Manufacture and sell D-24 Product to one other Impax Entity authorized to offer to sell,
import, package, and/or distribute D-24 Product in the United States, its territories and
possessions in compliance with the Settlement Agreement; and (iii) to market, promote, use,
distribute, sell, have sold, import, export, make or have made a Competing Product that IMPAX or
its Affiliate acquires through an acquisition, divestiture, merger, joint venture or other business
combination, provided that such Competing Product did not account for more than seventy percent
(70%) of the sales of the business acquired by IMPAX or its Affiliate in such transaction during
the twelve (12) month period immediately preceding the consummation of such transaction.”






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5. The last sentence of Section 4.2 is hereby amended in its entirety to read as follow:



“IMPAX shall use Commercially Reasonable Efforts to allocate capacity at the Facility to WCH so
that it can supply WCH with (i) three million (3,000,000) tablets of D-12 Product per calendar
month and (ii) up to three million (3,000,000) tablets per month of WCH’s forecasted requirements
of the D-24 Product on a priority basis over the other Impax Entity.”



6. Section 6.3 of the Agreement is hereby amended by adding new subsection 6.3.6 as follows:



“6.3.6 If WCH receives an offer for supply of D-24 Product at a price lower than the price for D-24
Product then in effect hereunder and WCH informs IMPAX of such offer, within thirty (30) days
thereafter either (i) IMPAX shall agree to meet such lower price for a quantity of D-24 Product
equal to the quantity offered by such other supplier or
(ii) WCH shall be free to source D-24 Product from such other supplier and in such latter event the
quantity of D-24 Product that WCH is obligated to purchase hereunder pursuant to Section 4.1 of
this Agreement shall be commensurately reduced and WCH shall- be relieved of its non-compete
obligation pursuant to Section 2.4 of this Agreement to the same extent.”



7. Subsections (iii), (v), (vii), (ix) and (xi) of Sections 6.1 of the Agreement are hereby amended
to read in their entirety as follows:




	 	 	 	 	 
	“(iii)

	 	Placement on: stability of a D-24 Product
pilot batch in WCH’s consumer blister
packaging
	 	$37,963”
	 
	 	 	 	 
	“(v)

	 	Filing with FDA an ANDA
supplement/amendment for D-24 Product to
support 24 month expiry based on stability
studies and WCH’s consumer blister
packaging
	 	$50,617”
	 
	 	 	 	 
	“(vii)

	 	WCH’s acceptance of successful scale-up
and validation (based on WCH’s approval of
final validation report) of D-24 Product
	 	$75,926”
	 
	 	 	 	 
	“(ix)

	 	The latter to occur of (a) January 1, 2003
or (b) final D-24 Product ANDA approval by
FDA with WCH’s consumer labeling and
blister packaging
	 	$227,778”
	 
	 	 	 	 
	“(xi)

	 	The latter to occur of (a) January 1, 2003
or (b) Launch of the D-24 Product by WCH
in the United States
	 	$632,716”





8. Section 7.2.1(1) of the Agreement is amended to add thereto a new subsection (f) that reads as
follows:






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“;and (f) in the case of D-24 Product, constitute Impax Products within the meaning of the
Settlement Agreement.”



9. Paragraph II of Section 9.3.2 of the Agreement is amended to read in its entirety as follows:



“II. D-24 Product



If on or before the date on which notice of termination is given for the D-24 Product, the event
described in Section 6.1(ix) has not occurred $227,778



or



If on or before the date on which notice of termination is given for the D-24 Product, the event
described in Section 6.1(ix) has occurred but the event described in Section 6.1(xi) has not
occurred $341,667



or



If on or before the date on which notice of termination is given for the D-24 Product, the event
described in Section 6.1(xi) has occurred Zero”



10. All other terms and conditions of the Agreement are hereby confirmed and shall remain in full
force and effect. In the event of any conflict with the provisions of this Amendment and any of the
provisions of the Agreement, the provisions of this Amendment shall control.




[SIGNATURES APPEAR ON THE FOLLOWING PAGE]






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IN WITNESS WHEREOF, the undersigned have executed this Amendment.



WYETH, acting through its Wyeth Consumer Healthcare Division




	 	 	 	 	 
	 	 	 
	 	By:  	/s/ Gregory E. Bobyock
 	 
	 	 	Name:  	Gregory E. Bobyock 	 
	  	 	Title:  	Vice President


Global Business Development
	 
	 	 	Date:  	June 29, 2004 	 
	 
	 	 	IMPAX LABORATORIES, INC.

 	 
	 	By:  	/s/ David S. Doll
 	 
	 	 	Name:  	David S. Doll 	 
	 	 	Title:  	Sr. Vice President, Sales & Mktg
	 
	 	 	Date:  	July 9, 2004 	 
	 




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