exv10w15w2






EXHIBIT 10.15.2




     XXXXX INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED.
ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.



Amendment No. 4 to

Licensing, Contract Manufacturing and Supply Agreement between

Schering Corporation

and

Impax Laboratories, Inc.




     This Amendment No. 4, effective as of the last date of signature appearing below (the
“Effective Date”), is entered into by and between Schering Corporation (hereinafter called
“Schering”) and Impax Laboratories, Inc. (hereinafter called “Impax”).



PURPOSE 




     WHEREAS, Schering and Impax are the parties to the Licensing, Contract Manufacturing and
Supply Agreement with an effective date of June 18, 2002, as subsequently amended by Amendment No.
1, dated November 22, 2002, Amendment No. 2, dated December 4, 2002, and Amendment No. 3, dated
July 15, 2004 (the “License Agreement”); and



     WHEREAS, Schering and Impax desire, in accordance with Section 16.7 of the License Agreement,
to amend certain aspects and provisions of the License Agreement related to the Pricing and Supply
of the Product and the license granted by Impax to Schering, as set forth below.



     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
have the meaning as defined in the License Agreement.
	 
	 	2.	 	Section 2.1(e) is amended to read in its entirety, as follows:






     (e) In consideration of the license rights granted pursuant to
Section 2.1(d), Schering agrees to pay Impax a total of $XXXXX per
XXXXX tablets of Product produced by Schering, or a Third Party
engaged by Schering to Manufacture the Product, and sold by
Schering, net of any and all returns (the “Royalty Amount”) during
the course of the twenty-four (24) months following the Manufacture
by Schering, its Affiliate or a Third Party



 









 







Manufacturer of the first commercial batch of Product following
the date of the completion of the Technology Transfer (as
hereinafter defined). Schering shall pay the Royalty Amount to Impax
on a quarterly basis within forty-five (45) days of the close of the
preceding calendar quarter. Upon payment of the Royalty Amount and
notwithstanding any other provision in the License Agreement to the
contrary, Schering shall not be obligated to make any further
payments for the license rights granted to it by Impax pursuant to
Section 2.1(d) herein.




	 	3.	 	Section 3.1, Supply of Product, is amended to read in its entirety as
follows:






     Subject to the terms and conditions of the License Agreement,
as amended, Impax shall Manufacture and supply Schering, and
Schering shall purchase from Impax, the Product in accordance with
Impax’s ANDA and in amounts to be determined by Schering in its sole
discretion (but no less than batch quantities).




	 	4.	 	Section 3.3, Good Faith Forecasts, and Section 3.4, Purchase
Orders, are deleted in their entirety.
	 
	 	5.	 	Section 3.7, Alternative Supply, is amended to read in its entirety, as
follows:






     Promptly following the execution of this Amendment No. 4, Impax
agrees to fully cooperate with Schering, at Schering’s request and
expense (except as set forth in the second paragraph of paragraph
(b) of this Section 3.7), to establish a facility for the
Manufacture of the Product at one of Schering’s, its Affiliates’ or
a Third Parties’ manufacturing sites and Impax shall promptly
initiate a complete technology transfer of the manufacturing
process, procedures and standards used by Impax to Manufacture the
Product (the “Technology Transfer”), so as to enable such facility
to Manufacture the Product in accordance with the applicable Health
Registrations for the Product. Impax and Schering shall use diligent
efforts to ensure that the Technology Transfer is completed as soon
as reasonably practicable, but by no later than March 1, 2009. The
license rights granted to Schering pursuant to Section 2.1(d) in
exchange for the Royalty Amount set forth in Section 2.1(e) shall
take effect upon the execution of this Amendment No. 4.




     In order to accomplish the Technology Transfer as efficiently
and as timely as possible, Impax shall provide the following
assistance to Schering (and such other assistance as requested by
Schering, subject to Impax’s agreement with respect to such
additional services):



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     (a) During the term of this Agreement, Schering shall be
permitted to conduct up to four (4) site visits at Impax’s
Manufacturing facilities of no longer than three (3) days’ duration
per visit and limited to no more than four (4) employees or agents
of Schering for technical discussions, to view Impax’s Manufacturing
process and to review and verify equipment capabilities.




     (b) No more than ten (10) times during the term of this
Agreement Schering may request Impax to provide its personnel at
Schering’s facilities for process development or technical services,
including product development, stability batch manufacturing and
technical transfer demonstration of batch capability, each site
visit to be no longer than three (3) days’ duration.




     Impax and Schering shall be responsible for their own domestic
travel expenses related to the foregoing site visits.




	 	6.	 	Section 3.8, Capacity, is amended to read in its entirety, as follows:






3.8 Impax Performance Obligation. To facilitate the
Manufacture and delivery of Products, beginning August 1, 2006 and
each month thereafter, Schering shall provide Impax with firm
purchase orders for the subsequent six (6) months on a rolling
six-month basis and the desired delivery dates for the Products so
ordered so as to enable Impax to plan and prioritize Schering’s
purchase orders to maximize the delivery of Products in order to
meet requested and agreed upon Schering delivery dates. Impax will
use its Commercially Reasonable Efforts to maintain the
Manufacturing priority and capacity required for Schering’s firm
purchase orders in order to meet agreed upon monthly delivery
quantities. The rolling six month firm purchase order schedule is
intended to provide both Impax and Schering with sufficient
notification of scheduling issues and changes as far out on the
horizon as possible. If Impax confirms that it is unable to meet
Schering’s purchase order quantity and delivery dates, the parties
agree to negotiate revised delivery dates.




	 	7.	 	Article III, Supplied Product, is hereby amended by adding the
following Section 3.9:






3.9 Optional Territory. Within twenty-four (24) months from
the date of execution of this Amendment, Schering shall have the
right to add Canada as an additional country in the Territory by
delivering notice thereof to Impax, provided that Impax shall not be
required to deliver to Schering and its Affiliates an aggregate of
more than XXXXX tablets of Products in any calendar year of this



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Agreement. The Price for the Products to be delivered to Schering’s
Canadian subsidiary shall be as set forth in Section 6.1. In all
other respects, the terms and provisions of this Agreement shall
govern the Manufacture and sale of Products to Schering’s Canadian
subsidiary.




	 	8.	 	Section 4.2, Cost Reductions (identified incorrectly as Section 7.2 in
Amendment No. 3), is hereby deleted in its entirety.
	 
	 	9.	 	Section 5.4, Delay and Failure to Supply, is hereby deleted in its
entirety.
	 
	 	10.	 	Section 6.1, Price, is hereby amended to read in its entirety, as
follows:






6.1 Price. Subject to the other provisions of this Section
6.1, the Price for the Product shall be as follows:




     (a) Beginning July 1, 2006, and through and including September
30, 2006, the Price shall be $XXXXX per XXXXX tablets;




     (b) Beginning October 1, 2006, through and including December
31, 2006, the Price shall be $XXXXX per XXXXX tablets; and




     (c) Beginning January 1, 2007, through and including June 30,
2007, the Price shall be $XXXXX per XXXXX tablets.




     The Price shall be paid in United States dollars within thirty
(30) days from the date of receipt of invoice therefor for the
Product received by Schering.




     The Price of Product ordered for delivery in calendar year 2007
in excess of XXXXX tablets shall be $XXXXX per XXXXX tablets in
excess of XXXXX tablets, plus the Cost Increases referred to below.




     If Impax successfully releases and ships batches to Anderson
during the months of July through December, 2006, according to the
schedule set forth below, within forty-five (45) days after the end
of each applicable month Schering shall pay to Impax the additional
sum of $XXXXX for each month that Impax successfully releases and
ships such scheduled batches to Anderson; provided,
however, that if there is a shortage in any month, Impax may
make up the shortage in the subsequent month in order to be paid the
$XXXXX amount for the short month.



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	 	 	 	 	No. Of Batches
	 	 	No. Of Batches	 	Required To Be Shipped
	 	 	Required To Be	 	By The End Of The
	2006 Month	 	Shipped	 	 Month
	June
	 	XXXXX
	 	XXXXX
	July
	 	XXXXX
	 	XXXXX
	August
	 	XXXXX
	 	XXXXX
	September
	 	XXXXX
	 	XXXXX
	October
	 	XXXXX
	 	XXXXX
	November
	 	XXXXX
	 	XXXXX
	December
	 	XXXXX
	 	XXXXX







     Prior to April 1, 2007, Impax shall provide to Schering
documentation supporting any increases since July 1, 2006 in the
cost of Raw Materials and Packaging Components and any other
increases in the cost of Manufacturing including labor, QC and QA
(collectively “Cost Increases”), and unless Schering objects to the
Cost Increases, the Price for the Product for the period July 1,
2007 through and including December 31, 2007, shall be $XXXXX per
XXXXX tablets plus the amount of the agreed upon Cost Increases (the
“2007 Price”). If the agreed upon Cost Increase is more than five
percent (5%) of $XXXXX, the Royalty Amount shall be reduced by the
amount by which the agreed upon Cost Increase exceeds $XXXXX.




     Prior to October 1, 2007, Impax shall provide to Schering
documentation supporting any Cost Increases since April 1, 2007, and
unless Schering objects to the Cost Increases, the Price for the
Product for the period January 1, 2008 through and including
December 31, 2008, shall be the 2007 Price plus the amount of the
agreed upon Cost Increases (the “2008 Price”). If the 2008 Price
exceeds the 2007 Price by more than five percent (5%), the Royalty
Amount shall be reduced by the amount of such excess.




     In the event that Impax supplies Product to Schering after
December 31, 2008, prior to October 1, 2008 Impax shall provide
Schering documentation supporting any Cost Increases since October
1, 2007 and unless Schering objects to the Cost Increases, the Price
for the Product shall be the 2008 Price plus the amount of the
agreed upon Cost Increases (the “2009 Price”). If the 2009 Price
exceeds the 2007 Price by more than ten percent (10%), the Royalty
Amount shall be reduced by the amount of such excess, and the amount
of any Royalty Amount reduction referred to in the preceding
paragraph shall not apply. If the 2009 Price does not exceed the
2007 Price by more than ten percent (10%), the Royalty Amount shall
be reduced only by the amount of any Royalty Amount reduction
referred to in the preceding paragraph.



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     If Schering shall object to a Cost Increase, it must so notify
Impax within thirty (30) days of receipt of Impax’s documentation
supporting the Cost Increase. If the parties are unable to agree
upon the Cost Increase within ten (10) days after Schering’s
objection, the parties will retain a mutually acceptable, nationally
recognized independent certified public accounting firm, which may
not be any of the parties’ primary outside accountants, to review
the relevant books and records and to submit to the parties its
written determination as to the amount of the Cost Increases and the
basis for its determination. The Cost Increase so determined shall
be retroactive to July 1, 2007, or January 1, 2008, or January 1,
2009, as the case may be. The determination by the independent
accounting firm will be binding on the parties absent manifest
error.




	 	11.	 	Section 8.4, Retention of Samples, is amended by adding the following
paragraph:






     Product supplied by Impax shall have a shelf life of at least
(a) thirty (30) months from the date of Manufacture for all Products
shipped during the period January 1, 2007 through June 30, 2007 and
(b) thirty-six (36) months from the date of Manufacture for all
Products shipped beginning July 1, 2007, unless Impax notifies
Schering that there are issues regarding stability results.




	 	12.	 	Section 11.2, Termination by Schering, is amended to read in its
entirety, as follows:






	 	11.2	 	Termination by Schering or Impax.






     (a) Schering shall have the right to terminate this Agreement
upon ninety (90) days’ prior notice to Impax if:




          (i) Impax is subject to any Regulatory Authority warning letter
or sanction which materially effects Impax’s ability to Manufacture
the Product and which is not being actively contested by Impax;




          (ii) there is a change in control of Impax. For purposes of
this provision, a “change in control” shall mean the acquisition of
direct or indirect ownership of over fifty percent (50%) of the
outstanding voting securities of Impax, or actual control over the
management, business and affairs of Impax, by a non-Affiliate
thereof; or




          (iii) Impax files a petition in bankruptcy, or enters into an
arrangement with its creditors, or applies for or consents to the
appointment of a receiver or trustee, or makes an assignment



6









 







for the benefit of creditors, or suffers or permits the entry
of an order adjudicating it to be bankrupt or insolvent. In the
event this Agreement is terminated under this Section 11.2(iii), all
rights and licenses granted pursuant to Section 10.2 of this
Agreement by Impax to Schering are, and shall otherwise be deemed to
be, for purposes of Section 365(n) of the Bankruptcy Code, licenses
of rights to “intellectual property” as defined under Section
101(52) of the Bankruptcy Code. The parties agree that Schering, as
a licensee of such rights under this Agreement, shall retain and may
fully exercise all of its rights and elections under the Bankruptcy
Code. The parties further agree that, in the event of the
commencement of a bankruptcy proceeding by or against Impax under
the Bankruptcy Code, Schering shall be entitled to a complete
duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual
property upon written request therefor by Schering. Such
intellectual property and all embodiments thereof shall be promptly
delivered to Schering (i) upon any such commencement of a bankruptcy
proceeding upon written request therefor by Schering, unless Impax
elects to continue to perform all of its obligations under this
Agreement or (ii) if not delivered under (i) above, upon the
rejection of this Agreement by or on behalf of Impax upon written
request therefor by Schering.




     (b) Schering shall have the right to terminate this Agreement
for any or no reason upon six (6) months’ prior notice to Impax
given at any time from and after July 1, 2008.




     (c) Impax shall have the right to terminate this Agreement upon
six (6) months’ prior notice to Schering given on the earlier of (i)
the date of completion of the Technology Transfer or (ii) on or
after July 1, 2008 for any or no reason.




     (d) In the event that no notice of termination is given by
either party prior to July 1, 2008, this Agreement shall be
automatically extended for an additional one (1) year term.




     (e) In the event Impax shall notify Schering of its intention
to terminate this Agreement pursuant to Section 11.2(c)(ii) and the
Technology Transfer has not been completed so as to enable Schering
or a Third Party to Manufacture the Product, the term of this
Agreement shall be extended for an additional period of three (3)
months beyond the termination date set forth in Impax’s notice of
termination. If Schering believes that the Technology Transfer
cannot be completed by March 1, 2009, and the failure to complete
the Technology Transfer is not due to an act or failure to act on
the part of Schering, Schering shall so notify Impax and the parties



7









 







shall then engage in good faith negotiations to modify and
extend the term of this Agreement so as to enable a continuity of
supply of the Product to Schering, which modification will include
increases in the price of the Product, it being understood that
notwithstanding the forgoing Impax is under no obligation to extend
the term of this Agreement beyond March 1, 2009.




	 	13.	 	Clause (b) of Section 13.2 is amended to read in its entirety, as follows:
	 
	 	 	 	the manufacture, marketing, packaging, storage, shipment, and sale
of Product in the Territory by Schering in each case, except to the
extent caused by the negligence or intentional misconduct of Impax.
	 
	 	14.	 	Except for use by Schering of the confidential information of Impax relative to
the license rights granted to Schering and the Technology Transfer hereunder, and
notwithstanding the provisions of the Secrecy Agreement entered into between Schering
and Impax on January 7, 2002 (the “Secrecy Agreement”) and the License Agreement to the
contrary, the confidentiality provisions of the Secrecy Agreement and License Agreement
shall survive the termination of the License Agreement for a period of ten (10) years.
	 
	 	15.	 	All other terms and conditions of the License Agreement are hereby confirmed
and shall remain in full force and effect. In the event of any conflict with the
provisions of this Amendment No. 4 and any of the provisions of the License Agreement,
the provisions of this Amendment No. 4 shall control.





	 	 	 	 	 
	 	SCHERING CORPORATION

 	 
	 	By:  	/s/ Richard J. Appledoorn
 	 
	 	 	Name:  	Richard J. Appledoorn 	 
	 	 	Title:  	General Manager
	 
	 	 	Date:  	December 15, 2006 	 
	 
	 	IMPAX LABORATORIES, INC.

 	 
	 	By:  	/s/ David S. Doll
 	 
	 	 	Name:  	David S. Doll 	 
	 	 	Title:  	Executive Vice President, Commercial
Operations
	 
	 	 	Date:  	December 13, 2006 	 
	 




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