EXHIBIT 10.2
AGREEMENT
---------
AGREEMENT entered into this 10th day of June 1994 by and between AKZO
PHARMA INTERNATIONAL B.V. and ORGANON INC. (hereinafter collectively referred to
as "AKZO"), and SCHEIN PHARMACEUTICAL, INC. and STERIS LABORATORIES, INC.
(hereinafter collectively referred to as "SCHEIN").
STATEMENT
---------
Akzo Pharma International B.V. and Organon Inc. are the owner and exclusive
licensee, respectively, of U.S. Patent No. 4,237,126 issued December 2, 1980
("the '126 patent") and U.S. Patent No. 4,297,351 ("the '351 patent") issued
October 27, 1981. By virtue of a terminal disclaimer in the '351 patent, both
patents expire on December 2, 1997. AKZO has FDA approval to market NORCURON(R)
(vecuronium, bromide) for injection. The aforesaid patents are listed in the FDA
Orange Book as patents which cover that approved product.
In April 1993, SCHEIN submitted ANDA 00-000 ("Xxx XXXX") to the Food and
Drug Administration under 21 USC (S) 355(j) seeking FDA approval to manufacture
and sell vecuronium bromide for injection in the United States prior to the
expiration of the '126 and '351 patents. The ANDA contained a certification by
SCHEIN asserting that the aforesaid patents were invalid and not infringed.
Simultaneous with the filing of The ANDA, as required by law, SCHEIN served AKZO
with a detailed statement of the facts
and law explaining its patent certification. Within forty-five (45) days after
receipt of the Patent Certification Notice, AKZO commenced an action against
SCHEIN in the United States District Court for the District of Arizona (Civil
Action No. CIV 93-1071 PHX EHC) for infringement of the '126 and '351 patents.
The '126 and '351 patents are presumed to be valid and enforceable as a
matter of law and the burden is on SCHEIN in the pending litigation to prove
otherwise by clear and convincing evidence. The cost and risk involved in patent
litigation coupled with the relatively short remaining patent life have led the
parties hereto to conclude that an amicable settlement of the controversy is the
most prudent course of action provided that any such settlement gives due regard
to both the presumptive validity of the patents and to the period of generic
exclusivity which SCHEIN would receive under 21 USC (S) 355(j)(4)(B)(iv) as a
result of a final judgment in its favor in the pending litigation. This
Agreement embodies the terms of that settlement.
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants
hereinafter contained the parties agree as follows:
1. As used in this Agreement:
"Affiliate" shall mean a company which is controlled by, controls or
is under common control with any party hereto, where control means ownership of
50% or more of stock or equity of the controlled company.
2
"PRODUCT" shall mean vecuronium bromide (for injection) in accordance
with The ANDA, regardless of dosage strength, or in accordance with any other
ANDA filed by SCHEIN or its Affiliates that employs vecuronium bromide
formulated with any pharmaceutically acceptable acid, as such acid is described
in the '126 patent or the '351 patent, for use as an injectable formulation.
"PROCESS" shall mean the manufacture of vecuronium bromide (for
injection) in accordance with The ANDA, regardless of dosage strength, or in
accordance with any other ANDA filed by SCHEIN or its Affiliates that employs
vecuronium bromide formulated with any pharmaceutically acceptable acid as
such acid is described in the '126 patent or the '351 patent.
2.(a) In the foregoing Civil Action No. CIV 93-1071 PHX EHC, the parties
agree to entry of the Consent judgment in the form attached as Exhibit A, or in
such other form acceptable to the parties and the Court and which enjoins SCHEIN
and its Affiliates from any manufacture, use or sale of PRODUCT, or performance
of PROCESS, before March 15, 1996, except as otherwise provided in this
Agreement.
(b) AKZO has no objection to the FDA giving SCHEIN the effective
approval date its ANDA would have been entitled to if no action for infringement
of the '126 and '351 patents had been commenced within the forty-five (45) day
period following service of the Patent Certification Notice. Nothing in this
provision alters the commencement date of the license of paragraph 4(a) of
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this Agreement or the injunction referred to in paragraph 4(a) of this
Agreement. AKZO will certify to the FDA the accuracy and effectiveness of this
Agreement and the license granted herein (a copy of which Agreement may be
provided to the FDA on a confidential basis), and will make all submissions
reasonably required by the FDA for the ANDA to receive the benefit of the
effective approval date described in this paragraph 2(b).
3. SCHEIN acknowledges that the '126 and '351 patents are valid and
enforceable and that the manufacture, use or sale of PRODUCT, or the performance
of PROCESS, for, by, or to SCHEIN or its Affiliates in the United States prior
to the expiration of the patents, except to the extent that such activities are
expressly permitted by this Agreement, would be acts of patent infringement
which would cause immediate irreparable harm and damage to AKZO such that they
would be entitled to a temporary restraining order and permanent injunction in
the United States District Court for the District of Arizona enjoining any such
activities by SCHEIN or its Affiliates prior to March 15, 1996, except to the
extent a date earlier than March 15, 1996 is otherwise permitted under the
terms of this Agreement.
4. (a) AKZO hereby grants to SCHEIN a license under the '126 patent and
the '351 patent to make, use and sell PRODUCT in the United States and to
perform PROCESS in the United States, subject to SCHEIN's fulfillment of all the
terms and conditions
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of this Agreement, including SCHEIN's obligations to pay royalties. The
aforesaid license shall commence on March 15, 1996 except to the extent a date
earlier than March 15, 1996 is otherwise permitted under the terms of this
Agreement. SCHEIN and its Affiliates are enjoined pursuant to Exhibit A from any
manufacture, use or sale of PRODUCT, or performance of PROCESS, before the
commencement date of the license under this Agreement, except as otherwise
provided in paragraph 4(c) of this Agreement. The license granted to SCHEIN
shall include the right to make and package PRODUCT two weeks prior to the
commencement date of the license provided that no PRODUCT is sold or shipped for
delivery to a customer prior,to the commencement date of the license.
(b) The license granted pursuant to paragraph 4(a) shall be an exclusive
license, except for the following reservations: (i) AKZO and its Affiliates
retain a license (which shall be a license that is nonassignable except as in
accordance with paragraph 16 and does not include a right to sublicense, except
as provided in paragraph 4(b)(ii) and except as required to have third parties
manufacture any products for AKZO and its Affiliates, or to perform any process
for AKZO and its Affiliates, that is covered by any claim of the '126 patent
and/or the '351 patent) to manufacture, have manufactured for AKZO and its
Affiliates, use and/or sell any products, or to perform any process, or to have
any process performed for AKZO and its Affiliates, that is covered by any claims
of the '126 patent and/or the '351 patent and (ii) AKZO retains the right to
grant licenses under the '351 patent and/or the '126 patent to
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any third party in connection with an action covered by paragraph 6(d), provided
that no such license under paragraph 4(b)(ii) shall be granted that commences
prior to the date provided in paragraph 6(d) of this Agreement. The license
granted to SCHEIN shall be a non-assignable license that does not include a
right to sublicense.
(c) The license granted pursuant to paragraph 4(a) of this Agreement
includes SCHEIN's right to engage in one or more of the following activities
prior to the commencement date of the license: (i) import raw materials prior to
the commencement date, and throughout the duration of the license, for testing
and research and development purposes, to satisfy FDA requirements, and for
PRODUCT manufacture as permitted by this Agreement; and (ii) conduct activities
(including without limitation manufacture of product exhibit batches) required
to obtain FDA approval. Nothing in this Agreement or Consent Judgment shall be
construed as preventing SCHEIN from engaging in any of the following activities:
(1) soliciting and entering into private labelling agreements for PRODUCT
beginning not more than three (3) months prior to the commencement date of the
license; (2) conducting activities required to obtain state formulary approvals
beginning not more than three (3) months prior to the commencement date of the
license; (3) engaging in pre-marketing promotional activities and soliciting
orders for PRODUCT beginning not more than eight (8) weeks prior to the
commencement date of the license, provided that no PRODUCT is sold or shipped
for delivery to a customer prior to the commencement date of the
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license; or (4) entering into agreements beginning not more than eight (8) weeks
prior to the commencement date of the license, to sell and deliver PRODUCT on
and after the commencement date of the license. The parties acknowledge that
SCHEIN may engage in any or all of the activities stated in this subparagraph
4(c), which shall be neither a breach of this Agreement nor a violation of the
Consent Judgment.
5. (a) SCHEIN agrees to pay to AKZO on all PRODUCT which SCHEIN or its
Affiliates sell prior to the expiration date of the '126 and '351 patents a
royalty on its Net Sales of such PRODUCT at the following rates: ***** *** ***
***** ******* ******* ** *** ***** *** ******* **** **** ***** **, **** *******
******* **, ****; **** ******* **** ** *** ***** *** ******* **** **** *******
**, **** ******* *** *, ****; *** *** *** ******** ******* ****** ** *** *****
*** ******* **** **** *** *, **** ******* ******** *, ****.
(b) "Net Sales" shall mean the total amount charged to third parties
by or on behalf of either SCHEIN or its Affiliates for PRODUCT, less only
charges for (i) taxes, (ii) freight and/or insurance that are separately
invoiced and paid by the third party for delivery, (iii) returns for credit, and
(iv) usual, customary and reasonable chargebacks, sales rebates or credits of
the type given in the normal course of business to particular classes of
customers to induce purchases of the PRODUCT for which the discount is given. In
calculating Net Sales, SCHEIN shall include a reasonable chargeback reserve for
estimated future
* redacted pursuant to confidential treatment request.
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claims to be made against current sales of PRODUCT. The chargeback provision
shall not exceed five (5) percent of the average monthly sales that are subject
to a chargeback during the licensed period. After each calendar year SCHEIN will
review the reserve amount against actual credits issued during the year on
chargeback claims of PRODUCT, and royalty payments shall be adjusted
accordingly. No other item shall be deducted in determining "Net Sales".
(c) In the event that AKZO shall grant a license to a business entity
that is not an Affiliate of AKZO to utilize the inventions of the '126 patent
and the '351 patent at a more favorable royalty rate than that specified in
paragraph 5(a), AKZO shall notify SCHEIN of the terms of such other license and
SCHEIN shall have the option of adopting such more favorable rate so long as
SCHEIN also adopts all the other terms and conditions of such other license;
provided any such other license shall commence on a date no earlier than that
permitted under paragraph 4(b)(ii) of the Agreement.
(d) The payments to be made by SCHEIN unless otherwise specified,
shall be made quarterly within thirty (30) days after each calendar quarter on
Net Sales of each PRODUCT made during the preceding calendar quarter. Such
payment shall be accompanied by a statement setting forth sufficient information
with respect to sales to enable AKZO to verify the basis for the payment being
made.
(e) SCHEIN shall at all times maintain accurate and complete
manufacturing and sales records with respect to all drug
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products for which payments are due in such a manner that the amount or payments
due and payable hereunder may be verified by independent auditors acceptable to
AKZO. AKZO may request such an audit but not more than once during any calendar
year during the term hereof and once within six (6) months after termination of
this Agreement. In the event the accountant determines an underpayment for the
period under audit, then SCHEIN shall pay the amount underpaid plus interest
pursuant to paragraph 5(f) hereof. In addition, if the underpayment is greater
than ten percent (10%), then SCHEIN shall also pay the reasonable cost of the
audit.
(f) SCHEIN shall pay interest to AKZO on any and all amounts of
royalties that are at any time over 30 days past due and payable to AKZO at an
annual rate equal to the prime rate, as published in "The Wall Street Journal"
for the day the royalties were due, from the date the royalties were due and
payable to the date paid.
(g) All payments made by SCHEIN to AKZO hereunder shall be made to
Organon Inc. at its address set forth in paragraph 15 or at such other address
as Organon Inc. shall specify by written notice.
6. (a) The license granted to SCHEIN pursuant to paragraph 4 hereof
shall become effective immediately in the event that a generic version of
NORCURON(R) is offered for sale in the United States by AKZO, or any Affiliate
of AKZO; and AKZO shall notify SCHEIN of its (or its Affiliate's) intention to
so
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offer a generic version for sale, no less than ninety (90) days prior to so
offering. For purposes of this Agreement, a "generic version" means any
vecuronium bromide product manufactured by, for or on behalf of AKZO or any
Affiliate of AKZO which does not bear the NORCURON(R) brand.
(b) If AKZO hereafter receives a Patent Certification Notice pursuant
to 21 USC (S) 355(j) which challenges the validity or enforceability of the '126
or '351 patents, AKZO shall provide SCHEIN with a copy of all documents
received as part of the Notice within ten (10) days after receipt thereof.
within forty-five (45) days after receipt of the Notice, AKZO shall inform
SCHEIN as to whether an action for infringement of the aforesaid patents has
been commenced against the party who served the Patent Certification Notice. If
no action is commenced within forty-five (45) days after receiving such a Patent
Certification Notice, the license granted under paragraph 4(a) shall commence on
the 45th day following the receipt of the Patent Certification Notice by AKZO.
AKZO represents to SCHEIN that it has not received, nor has knowledge of, any
Patent Certification Notice from any third party (other than SCHEIN), which
challenges the validity or enforceability of the '126 and/or the '351 patent.
(c) If following receipt of a Patent Certification Notice as
described in paragraph 6(b) an action for infringement of the '126 and '351
patents is commenced by AKZO within forty-five (45) days after receiving a
Patent Certification Notice which challenges the aforesaid patents, AKZO agrees
that
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it will provide SCHEIN with a copy of any trial court decision rendered in that
action. If the trial court's decision holds the aforesaid patents invalid, not
infringed or unenforceable then the license under paragraph 4(a) shall commence
on the date on which the trial court decision is rendered.
(d) If an action for infringement of the '126 and '351 patents is
commenced within forty-five (45) days after receiving a Patent Certification
Notice which challenges the aforesaid patents, AKZO agrees it will provide
SCHEIN with immediate written notice of any voluntary dismissal or settlement of
such litigation. Any license granted by AKZO in connection with such dismissal
or settlement shall commence no earlier than September 15, 1996, unless the
license granted to SCHEIN under paragraph 4(a) of this Agreement has theretofore
commenced pursuant to paragraph 6(a) or 6(b), in which event any license granted
by AKZO in connection with such dismissal or settlement shall commence no
earlier than 6 months following the commencement date of the license granted to
SCHEIN.
7. SCHEIN and its Affiliates agree that they will not file a Request for
Reexamination of the '126 patent or the '351 patent in the United States Patent
and Trademark office.
8. (a) If SCHEIN has not received FDA approval pursuant to The ANDA to
commence manufacture and sale of the PRODUCT which is rated AP to NORCURON(R) on
a date which is sufficiently prior to AKZO or its Affiliate offering for sale in
the United States
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prior to March 15, 1996 a generic version of NORCURON(R) to enable SCHEIN to
build the inventory needed to fulfill its customers' requirements for PRODUCT
beginning on the date of AKZO's or its Affiliate's first offering a generic
version of NOCURON(R), AKZO agrees that it shall sell PRODUCT to SCHEIN and
shall fulfill SCHEIN's requirements for such inventory in accordance with the
provisions of this paragraph 8, from the date of AKZO's or its Affiliate's first
offering a generic version of NORCURON(R) through the period of the license
granted under paragraph 4(a) of this Agreement, but ending when SCHEIN receives
FDA approval and begins commercial manufacture of PRODUCT.
(b) PRODUCT which AKZO shall supply to SCHEIN-under paragraph 8(a) of
this Agreement shall be packaged and labeled in the same manner as those
products would have been packaged and labeled by SCHEIN for sale to its
customers in accordance with its customary business practices in manufacturing
and selling generic versions of branded pharmaceutical products, provided that
such packaging and labeling are in conformance with AKZO's NORCURON(R) NDA and
provided further that AKZO will cooperate with SCHEIN by providing documentation
as reasonably requested by SCHEIN and which is necessary to identify the PRODUCT
as manufactured under AKZO's NORCURON(R) NDA. SCHEIN shall reimburse AKZO for
all out-of-pocket expenses incurred by AKZO respecting any label, package insert
or packaging change vis-a-vis the present FDA approved specifications under the
NORCURON(R) NDA required for AKZO to supply PRODUCT to SCHEIN under this
paragraph 8, provided all expenses in excess of $1,000 are
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approved in advance by SCHEIN. Reimbursement shall take place within 30 days
after each invoice for substantiated expenses is sent to SCHEIN for payment.
Promptly after AKZO gives notice to SCHEIN pursuant to paragraph 6(a) of this
Agreement, representatives of AKZO and SCHEIN shall confer for the purpose of
defining and initiating the steps which may be required to supplement
AKZO's NORCURON(R) NDA and/or The ANDA so that any FDA approval required for
AKZO to manufacture PRODUCT and any state formulary,approvals required for the
sale of PRODUCT by SCHEIN shall be obtained on a date which is sufficiently
prior to the date of AKZO's or its Affiliate's first offering for sale a generic
version of NORCURON(R). AKZO and SCHEIN representatives shall also confer after
AKZO gives notice to SCHEIN pursuant to paragraph 6(a) of this Agreement for the
purpose of establishing estimates of SCHEIN's potential requirements for
PRODUCT, to establish procedures for placing orders for PRODUCT, and to deal
with any other questions which should be resolved in order to assure that SCHEIN
receives its PRODUCT requirements in a timely fashion. Each lot of PRODUCT
delivered by AKZO under paragraph 8 of this Agreement shall be accompanied by a
certificate of analysis.
(c) The price SCHEIN is to pay AKZO for PRODUCT purchased under this
paragraph 8 shall be the lesser of (i) ****** ******* ***** of AKZO's then
current average selling price of NORCURON(R) and (ii) *** ***** AKZO's standard
cost of goods for PRODUCT (but in no event less than AKZO1s standard cost of
goods for PRODUCT). For so long as SCHEIN sells PRODUCT purchased from
* redacted pursuant to confidential treatment request.
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AKZO pursuant to paragraph 8 of this Agreement, SCHEIN shall not be required to
pay the royalty set forth in paragraph 5(a) of this Agreement.
(d) AKZO shall at all times maintain accurate and complete
manufacturing and sales records with respect to all PRODUCT sold to SCHEIN under
paragraph 8 for which payments are due in such a manner that the amount or
payments due and payable hereunder may be verified by independent auditors
acceptable to SCHEIN. SCHEIN may request such an audit but not more than once
during any calendar year during the term hereof and once within six (6) months
after termination of this Agreement. In the event the accountant determines an
overpayment for the period under audit, then AKZO shall pay the amount overpaid
plus interest pursuant to paragraph 8(e) hereof. In addition, if the overpayment
is greater than ten percent (10%), then AKZO shall also pay the reasonable cost
of the audit.
(e) SCHEIN shall pay interest to AKZO on any and all amounts of the
price for PRODUCT purchased under paragraph 8 that are at any time over 30.days
past due and payable to AKZO at an annual rate equal to the prime rate, as
published in "The Wall Street Journal" for the day the price for PRODUCT
purchased under paragraph 8 was due, from the date the price for PRODUCT
purchased under paragraph 8 was due and payable to the date paid.
(f) All payments made by SCHEIN to AKZO hereunder shall be made to
Organon Inc. at its address set forth in paragraph 15 or at such other address
as Organon Inc. shall specify by written notice.
14
(g) AKZO shall provide to SCHEIN information and data regarding the
PRODUCT sold to SCHEIN under paragraph 8 of this Agreement, in the possession or
control of AKZO or any of its Affiliates which is required by SCHEIN for use
before any state or federal regulatory body.
(h) AKZO warrants that the PRODUCT supplied by it under paragraph 8
of this Agreement (i) shall conform to all requirements of the NORCURON(R) NDA,
USP specifications and all applicable federal, state or local law or regulation,
and (ii) at the time of shipment or delivery to SCHEIN shall not be adulterated
or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, and
not an article which may not, under the provisions of the Act, be introduced
into interstate commerce. AKZO agrees to indemnify and hold SCHEIN and its
Affiliates harmless against any and all claims, liabilities, damages and costs,
including reasonable attorney fees and other costs of defense, arising directly
or indirectly from breach of any of the foregoing warranties, provided that
SCHEIN gives AKZO prompt notice of any such claims, liabilities, damages and
costs.
(i) Promptly after AKZO gives notice to SCHEIN pursuant to paragraph
6(a) of this Agreement, SCHEIN shall use all commercially reasonable efforts to
begin the commercial manufacture of PRODUCT as soon as possible following
approval of The ANDA.
9. Nothing in the Agreement shall be construed as an obligation on the
part of AKZO to furnish any manufacturing or
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technical information, except for certificates of analysis when AKZO is selling
PRODUCT to SCHEIN under paragraph 8 of this Agreement.
10. SCHEIN and AKZO agree to maintain the terms and conditions of this
Agreement confidential, and not to otherwise disclose the contents of this
Agreement or its terms, except as required by law or as contemplated by this
Agreement.
Neither SCHEIN nor AKZO will make any public announcement or issue any
press release regarding this Agreement or the relationship between SCHEIN and
AKZO as set forth herein without the prior written approval of the other
parties, except in connection with SCHEIN's promotion and sale of PRODUCT and
then only to the extent to indicate that SCHEIN has a license under the '126
patent and the '351 patent.
11. No obligation is created by this Agreement that shall require AKZO to
enforce the '126 patent and/or the '351 patent against others. AKZO retains the
sole right to enforce the '126 patent and/or the '351 patent.
12. (a) AKZO may terminate this Agreement thirty (30) business days after
written notice to SCHEIN of failure to pay royalties or any other required
payment under this Agreement which are due and payable, if SCHEIN has not cured
any such default during the notice period.
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(b) In the event of Termination of this Agreement, all monetary
consideration pursuant to paragraph 5 that has accrued but is unpaid shall
immediately become due and payable.
(c) AKZO's exercise of their termination right does not constitute
waiver of any other rights or remedies that AKZO may have against SCHEIN.
13. The failure of any Party to insist upon the strict performance by any
other Party of any provision of this Agreement, or to exercise any right or
remedy consequent upon a breach thereof, shall not constitute a waiver of such
breach or of such provision or any other provision of this Agreement. The
failure of any Party to exercise its rights to enforce any provision of this
Agreement shall not prevent such Party from fully exercising its rights or
enforcing any provision at another time.
14. This Agreement constitutes the entire agreement between the Parties
and contains all of the agreements between the Parties with respect to the
subject matter hereof. This Agreement supersedes any and all other agreements,
whether oral or in writing, between the Parties with respect to the subject
matter hereof. This Agreement may be amended or modified only by a written
Agreement signed by the parties.
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15. All notices or other communications provided for in this Agreement
shall be deemed sufficiently given when set forth in writing and sent by
certified or registered mail, return receipt requested, by overnight express
courier or by telefax or telex, followed by a written confirmation sent in
accordance with this paragraph, and shall be addressed as follows:
For Akzo: Akzo Pharma International B.V.
Wethouder van Xxxxxxxxxx 0
0000 XX Xxx
Xxx Xxxxxxxxxxx
Attention: Head of Legal Affairs
For Organon: Organon Inc.
000 Xx. Xxxxxxxx Xxxxxx
Xxxx Xxxxxx, XX 00000
Attention: Vice President and General Counsel
For Steris: Steris Laboratories Inc.
000 X. 00xx Xxxxxx
Xxxxxxx, XX 00000
Attention: Senior Vice President
and General Manager
For Schein: Schein Pharmaceutical Inc.
000 Xxxxxx Xxxxx
Xxxxxxx Xxxx, XX 00000
Attention: Chairman
Any party may change the address for the giving of Notices to it by appropriate
notice to the other Parties.
16. None of the rights, obligations, covenants, or license under this
Agreement shall be assignable in whole or in part by any party hereto without
the express prior written consent of the other party, except that AKZO may
assign this Agreement in whole or in part to another entity as part of any
change in the corporate structure,, identity or ownership of AKZO, including,
but not limited to, mergers, acquisitions, sales, etc.
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17. This Agreement is made under and shall be construed in accordance with
and governed by the laws of the State of New Jersey and the Court of Appeals for
the Federal Circuit. The United States District Court for the District of
Arizona shall have exclusive jurisdiction in all matters arising under this
Agreement, and the parties hereto expressly consent and submit to the personal
and subject matter jurisdiction of such Court.
18. This Agreement shall be executed by each Party in duplicate originals,
each of which shall be deemed an original, but both originals together shall
constitute only one and the same instrument.
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IN WITNESS WHEREOF, the parties hereto have caused this instrument to be
executed as of the day and year first above written.
AKZO PHARMA INTERNATIONAL B.V. SCHEIN PHARMACEUTICAL INC
By: [SIGNATURE ILLEGIBLE] By: [SIGNATURE ILLEGIBLE]
------------------------ ------------------------
Authorized officer Authorized officer
By: [SIGNATURE ILLEGIBLE]
------------------------
Authorized officer
ORGANON INC. STERIS LABORATORIES, INC.
By: [SIGNATURE ILLEGIBLE] By: [SIGNATURE ILLEGIBLE]
------------------------ ------------------------
Authorized officer Authorized officer
By: [SIGNATURE ILLEGIBLE]
------------------------
Authorized officer
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EXHIBIT A TO AGREEMENT
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
_____________________________________
AKZO PHARMA INTERNATIONAL B.V. and )
ORGANON INC., )
)
Plaintiffs, )
) Civil Action No.
V. ) CIV 93-1071 PHX EHC
)
STERIS LABORATORIES INC., )
SCHEIN PHARMACEUTICAL INC. ) CONSENT JUDGMENT
) PURSUANT TO RULE 54(a)
Defendants. ) ----------------------
_____________________________________
As a result of Akzo Pharma International B.V. and Organon Inc. (hereinafter
"Plaintiffs") and Steris Laboratories Inc. and Schein Pharmaceutical Inc.
(hereinafter "Defendants") having executed an Agreement dated June 10, 1994 (the
"AGREEMENT") wherein, inter alia, Defendants have acknowledged the validity and
enforceability of United States Patent No. 4,237,126 (hereinafter the "'126
Patent") and United States Patent No. 4,297,351 (hereinafter the "'351 Patent")
and their infringement of those patents, the parties consent to entry of the
following ORDER and JUDGMENT:
(1) Defendants are enjoined until March 15, 1996 from the manufacture, use
and/or sale of the PRODUCT as defined in the AGREEMENT and the use of the
PROCESS as defined in the AGREEMENT, except as otherwise provided in the
AGREEMENT;
(2) All counterclaims and defenses raised in this action by Defendants
are dismissed with prejudice, each party to bear its own attorney's fees and
costs;
(3) The AGREEMENT entered into between the parties, which has been filed
with this Court under seal, is adopted by the Court as part of this ORDER and
JUDGMENT;
(4) The '126 Patent and the '351 Patent are valid and enforceable, and
Defendants agree that they are precluded from challenging the validity and
enforceability of these patents, even in subsequent litigation involving the
same or new claims or the same or new causes of action;
(5) The unlicensed manufacture, use and/or sale of the PRODUCT as defined
in the AGREEMENT, and the unlicensed use of the PROCESS as defined in the
AGREEMENT, infringes the '126 Patent and the '351 Patent, and the filing of ANDA
74-334 infringes the '126 Patent and the '351 Patent, and Defendants agree that
they are precluded from challenging that such activities are an infringement of
these patents, even in subsequent litigation involving the same or new claims or
the same or new causes of action; and
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(6) This Court retains jurisdiction to enforce this ORDER and JUDGMENT and
the parties' AGREEMENT.
By:__________________________________
Attorney for Plaintiffs
Akzo Pharma International B.V. and
Organon Inc.
By:__________________________________
Attorney for Defendants
Steris Laboratories Inc. and
Schein Pharmaceutical Inc.
IT IS SO ORDERED:
DATED this_____ day of_____, 1994.
__________________________________
The Xxxxxxxxx Xxxx X. Xxxxxxx
United States District Judge
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