Document:

exv10w15w1

EXHIBIT 10.15.1

     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. 3

TO

LICENSING, CONTRACT MANUFACTURING AND SUPPLY AGREEMENT

BETWEEN

SCHERING CORPORATION

AND

IMPAX LABORATORIES, INC.

     This Amendment No. 3, effective as of the last date of signature appearing below (the
“Effective Date”), is entered into by and between Schering Corporation, (hereafter called
“Schering”), and Impax Laboratories, Inc., (hereafter 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, and Amendment No. 2 dated December 4, 2002 (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, the License granted by Impax to Schering and the responsibility for reporting Adverse
Event information 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 1.17 is amended to read in its entirety as follows:

     The term “Initial Term” shall mean the period of time beginning on the Effective Date
of the License Agreement and ending February 28, 2008.

     3. Section 1.29 is amended to read in its entirety as follows:

 

 

     The term “Price” shall mean the Price set forth in Section 6.1 hereof.

     4. Section 1.32 is amended to read in its entirety as follows:

     The term “Supply Failure” shall mean Impax’s failure to Manufacture and deliver to
Schering on more than one occasion at least 95% of the amount of Product ordered by Schering
pursuant to the forecasts referred to in Section 3.3, for one calendar month by the delivery
date set forth in Schering’s purchase order.

     5. Section 2.1, License Fee, is amended by adding the following new Sections 2.1(d),
(e) and(f):

     (d) In consideration of the Royalty Amount set forth in Section 2.1(e) below, Impax hereby
grants to Schering, effective upon the earlier of: (a) the
delivery by Impax of the 480 million tablets,
as provided in Section 3.1 (as such amount may be adjusted in accordance with Section 5.4(a)), or
(b) approval by FDA to allow Schering or its designated party to manufacture the Product under
Impax’s ANDA or (c) such other date as otherwise agreed to by the parties, a non-exclusive,
transferable, assignable, irrevocable, non-expiring license under Impax’s ANDA, Know-How, and other
intellectual property as they relate to the Product and the other rights granted to Schering under
the Agreement, including, but not limited to rights to manufacture, market, and distribute the
Product. So long as Impax is supplying the Product to another customer, Impax shall not withdraw
the ANDA, and shall be obligated to, and shall perform at its own expense, all acts necessary to
maintain the ANDA in full force and effect, it being understood that Schering shall continue to
furnish Impax with the information required for those portions of the ANDA specific to Schering.
Within thirty (30) days after written notification from Impax that Impax is no longer required to
maintain the ANDA for its other customer, Schering shall notify Impax if it desires Impax to
continue to maintain the ANDA and Impax shall, until otherwise notified by Schering, perform, at
Schering’s expense, all acts necessary to maintain the ANDA in full force and effect. In such event
and at Schering’s request, the parties shall enter into good faith negotiations regarding the
transfer of the ANDA to Schering, and Schering shall have the right of first refusal in connection
with any transfer or other disposition of the Impax ANDA, other than a transfer or other
disposition to an Affiliate of Impax. In the alternative, Schering may choose to file for its own
ANDA using Impax Know-How, in which case Impax shall be obligated to maintain at Schering’s
expense, the Impax ANDA for the Product until Schering receives FDA approval for Schering’s ANDA.
In any event, the amount, if any, that Impax may charge to Schering for maintaining the Impax ANDA
pursuant to this Section 2.1(d) shall be limited to the reasonable, actual, documented costs
incurred by Impax for maintaining the ANDA. Invoices for any such amount charged to Schering shall
be sent by Impax on an annual basis, and shall be accompanied by a detailed statement itemizing the
costs. Such invoices shall be paid by Schering within 30 days of receipt. Impax shall keep records
sufficient in detail to enable Schering to verify the amounts charged. Schering shall have the
right, at its discretion and expense, to inspect, during ordinary business hours of Impax, records
as may be necessary to verify the amounts charged by Impax pursuant to this Section 2.1(d). Without
limiting the generality of the foregoing, Impax shall, subject to the provisions of Section 7.6, be
responsible for filing any and all ADE (as herein defined) reports.

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     (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 and sold by it,
net of any and all returns (the “Royalty Amount”), during the course of the 24 months following the
date of the completion of the Technology Transfer (as hereinafter defined), provided that Impax is
no longer obligated to supply the Product to Schering, or if so obligated, the date on which Impax
has delivered to Schering a total of 480 million tablets (subject to any adjustment in accordance with
Section 5.4 (a))of the Product and is no longer required to deliver any additional Product to
Schering. Schering shall pay the Royalty Amount to Impax on a quarterly basis within 45 days of the
close of the preceding calendar quarter. Upon payment of this 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.

     (f) Payments due under Section 2.1(e) shall be accompanied by a statement detailing the number
of tablets manufactured by Schering and sold by it, net of any and all returns, and the calculation
of the payment owed to Impax. Schering shall keep records in sufficient detail to enable Impax to
verify the calculation of the payment. Impax has the right, at its discretion and expense, but no
more frequently than one (1) time per calendar year, to inspect, during ordinary business hours of
Schering, records as may be necessary to verify Schering’s calculation of any payment due under
Section 2.1(e).

     6. 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 to 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 size quantities); provided that, and subject to Section 5.4(a), Impax shall
Manufacture and supply to Schering, and Schering shall purchase from
Impax, a minimum total of 480 million tablets of the Product during the period beginning March 1, 2004 and ending February 28,
2008; provided further, however, that in the event that FDA or any other Regulatory Authority shall
take any action, the effect of which is to prevent or prohibit Schering from marketing and
distributing the Product, Schering shall be relieved of its obligation to purchase any minimum
quantity of the Product.

     During
calendar year 2004, Impax agrees to manufacture and deliver to
Schering 20 million tablets
of the Product per calendar month for each of the calendar months of March, April, May, June, July
and August; provided, however, that Impax may deliver the
20 million tablets due for the month of April,
2004 to Schering by May 10, 2004. Impax shall thereafter be
obligated to produce up to 200 million tablets of the Product for any remaining calendar year of the Initial Term. Impax shall deliver
Schering’s requirements of the Product as per Schering’s delivery dates on Schering’s Purchase
Orders. Impax represents and warrants that it has and will maintain the capacity to Manufacture up
to 20 million tablets per month for the duration of the Initial Term, and further represents and
warrants that it will Manufacture and deliver to Schering at least
16.667 million tablets in any given
month, subject to receipt of forecasts and purchase orders in accordance with Sections 3.3 and 3.4
of the Agreement. Notwithstanding the foregoing, Impax will use its Commercially Reasonable
efforts, during the Initial Term, to supply Schering with more than
16.667 million tablets, up to 20 million tablets, in any given calendar month, subject to

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receipt of forecasts and purchase orders. Nothing herein shall be construed as restricting or
limiting Schering’s right to manufacture the Product at Schering’s or its Affiliate’s facilities
for use and/or sale.

     7. Section 3.7, Alternative Supply, is amended to read in its entirety as follow:

     Impax agrees to fully cooperate with Schering, at Schering’s request and expense, to establish
a back-up facility for the manufacture of the Product at one of Schering’s, its Affiliate’s or
Third Party’s manufacturing sites. Upon such request, 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 the back-up 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.

     8. Section 7.2, Cost Reductions, is hereby deleted in its entirety.

     9. Section 5.4(a), Delay and Failure to Supply, is amended to read in its entirety as
follows:

     (a) In the event that Impax shall have reason to believe that it will be unable to supply
Schering in a timely manner with the full quantity of the Product forecasted to be ordered or
actually ordered by Schering, Impax shall promptly (and in any event within five (5) business days)
notify Schering thereof. If Impax shall so notify Schering, or if Impax shall fail to provide
Schering with adequate assurances of timely performance upon Schering’s request therefore
(regardless of whether past performance has complied herewith or not), Schering and Impax shall
promptly meet to discuss how to thereafter supply the Product in a timely manner.

If at any time Schering determines in its reasonable judgment that there will be a Supply Failure,
or that there is a Supply Failure, then Schering or an Affiliate of Schering may (but shall not be
obligated to) Manufacture such quantity of the Product or its equivalent that Impax is unable to
produce or has failed to deliver or, Schering or its Affiliate may enter into a Supply Agreement
with a Third Party to manufacture such quantity of the Product or its equivalent that Impax is
unable to produce and deliver (taking into account minimum batch sizes and pricing efficiencies of
such supplier), upon such terms and conditions as Schering shall determine in its sole discretion.
If the Cure Price for the Supply Failure is in excess of the Price, Schering shall invoice Impax
for an amount equal to the excess of the Cure Price over the Price and provide reasonable
documentation evidencing the Cure Price to Impax with such invoice. Impax shall pay such invoice
within 30 days and such payment obligation shall constitute Impax’s sole and exclusive liability
for claims under this Section 5.4(a) where Schering elects to either Manufacture the Product itself
or enter into an agreement with a Third Party to do so.

Notwithstanding the foregoing, with regard to any supply agreement or the Manufacture of the
Product by Schering or an Affiliate of Schering, Impax shall pay the Cure Price in excess of the
Price for the longer of three (3) months from the date of a Supply Failure or the date that Impax
advises Schering that it is able to resume deliveries of the Product in the amounts referred to in
Section 3.1.

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In the event a Supply Failure occurs in any given month (“Short Month”), and Schering elects not to
Manufacture the Product or to enter into an agreement with a Third Party to do so, then

(i) In addition to delivering the full quantity of Schering’s order for the immediately following
month, Impax shall also deliver to Schering the amount of any shortage from the Short Month (“Cure
Amount”) in the immediately following calendar month (“Cure Month”), unless otherwise directed by
Schering. Subject to subparagraph (ii) below, pricing for all Product delivered during any Short
Month and any Cure Month shall be $69.65 per 1000 tablets of the Product.

(ii) Should Impax fail to deliver any given full Cure Amount, then pricing shall be at the price of
$ 60 per 1000 tablets (the “Amended Cure Price”), which Amended Cure Price shall remain in
effect for a minimum of the next three months (the “Minimum Cure Period”) and in any event, until
the full Cure Amount(s) and all amounts required pursuant to Schering’s regular orders have been
delivered. Upon delivery of all Schering’s requirements pursuant to its regular orders and the full
Cure Amount(s), or the expiration of the Minimum Cure Period, whichever is later, the price to be
paid by Schering for Product ordered and delivered thereafter shall revert back to $ 69.65 per
1000 tablets.

(iii) In addition to, and notwithstanding the foregoing cure obligations of Impax, Schering shall
be relieved from the minimum purchase obligation established pursuant to the Amended Section 3.1
set forth above. Subject to the provisions of Section 3.1, Impax shall nevertheless be required for
the remainder of the Initial Term to Manufacture and supply to Schering, and Schering shall
purchase from Impax, the Product, in amounts to be determined by Schering in its sole discretion
(but no less than current batch size quantities), at the price set forth in subparagraph
5.4(a)(ii), above, as applicable.

     10. Section 6.1, Price, is hereby amended to read in its entirety as follows:

     Beginning March 1, 2004, and subject to Section 5.4(a), the Price to be paid by Schering to
Impax for the Product during the Initial Term shall be $ 69.65 per 1000 tablets, and shall be made
in United States dollars within 30 days from date of receipt of invoice therefore for Product
received by Schering. After February 28, 2008, the Price to be paid by Schering to Impax for the
Product may be increased for any increase in the United States Consumer Price Index for material,
labor and overhead costs during the immediate preceding year, but in no event shall such cost
increase be more than a total of three percent (3%) for such year over the Price at the end of the
immediate preceding year.

     11. Section 7.6 of the Agreement, Adverse Events, is hereby amended to read in its
entirety as follows:

     Commencing no later than February 1, 2005, Impax shall be responsible for, and shall bear the
expense of collecting and reporting to FDA in accordance with the applicable laws and regulations,
all Adverse Drug Experiences (ADEs) regarding the Product; until such date, Impax shall only be
responsible for reporting to FDA all ADEs. In the event Schering shall receive an ADE for the
Product, Schering shall notify Impax within five (5) business days if the ADE is

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serious or unexpected, and on a quarterly basis with respect to any non-serious or expected
ADEs.

     12. Section 8.4, Retention of Samples, is hereby amended by adding the following Section
8.4(a):

     Until such time as Schering or its designated party receives approval by FDA to manufacture
the Product under Impax’s ANDA, Impax shall be responsible for, and shall bear the expense of,
conducting all ongoing stability requirements in accordance with applicable laws and regulations
and all applicable Schering requirements for all presentations of the Product marketed by Schering.
Notwithstanding the foregoing, Impax shall only be required to bear the expense of the conduct of
on-going stability testing for the initial three (3) batches of Product heretofore manufactured for
Schering and for one (1) batch of Product manufactured during each year of the Initial Term. If
Schering shall require the conduct of additional stability testing, Schering shall pay to Impax the
sum of $ XXXXX for each batch tested.

     13. 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. 3 and any of the provisions of the License Agreement, the provision of this Amendment No. 3
shall control.

	 	 	 	 	 	 	 	 	 
	SCHERING CORPORATION	 	 	 	IMPAX LABORATORIES, INC.
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Jerry Martino
	 	 	 	By:
	 	/s/ David S. Doll
	 

	 	 
	 	 	 	 	 	 
	 

	 	Jerry Martino
	 	 	 	 	 	David S. Doll
	 

	 	Vice President
	 	 	 	 	 	Sr. Vice President
	 

	 	 	 	 	 	 	 	Sales and Marketing
	 
	 	 	 	 	 	 	 	 
	Date:

	 	7/19/04
	 	 	 	Date:
	 	7/23/04

6exv10w15w2

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
	 	32
	 	Batch Carry-Over
	July
	 	19
	 	51
	August
	 	19
	 	70
	September
	 	19
	 	89
	October
	 	19
	 	109
	November
	 	19
	 	127
	December
	 	19
	 	146

     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 	 
	 

8

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