Exhibit 10.15
29 OCT 1990:1
***
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DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
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SCHERING CORPORATION
AND
ENZON, INC.
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*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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INDEX
Page
----
Article 1 : Definitions 2
Article 2 : Development Program 8
Article 3 : Manufacture of Commercial Quantities of Agreement
Product; Know-How Transfer 13
Article 4 : Exclusive License 18
Article 5 : Patent Rights 20
Article 6 : Payments 23
Article 7 : Royalty Terms 24
Article 8 : Royalty Payment Terms 28
Article 9 : Term and Termination 31
Article 10 : Representations and Warranties; Indemnification 33
Article 11 : Confidentiality 38
Article 12 : Governing Law 41
Article 13 : Assignment or Delegation 42
Article 14 : Force Majeure 43
Article 15 : Independent Contractor; Publicity 44
Article 16 : No Inconsistent Obligations 45
Article 17 : Severability; Survival 45
Article 18 : Captions 46
Article 19 : Waiver 46
Article 20 : Notice 47
Article 21 : Entire Agreement 47
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SCHEDULES
Schedule A-1 - Specifications for Agreement Substance
A-2 - Specifications for Bulk Concentrate
A-3 - Specifications for Agreement Product
Schedule B - Development Program
Schedule C - Patent Rights
Schedule D - Criteria for Efficacy in Pilot Study
Schedule E - Supply Agreement
Schedule F - Press Release
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DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
This agreement is made and effective as of November 14, 1990 by and between
ENZON, Inc.
00 Xxxxxxxx Xxxx
Xxxxx Xxxxxxxxxx, XX 00000-0000, a Delaware corporation,
hereinafter referred to as "ENZON",
and
SCHERING Corporation
0000 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000, a New Jersey corporation,
hereinafter referred to as SCHERING:
WHEREAS, SCHERING markets a proprietary pharmaceutical alpha interferon product
(hereinafter "Intron A") in various finished pharmaceutical dosage forms; and
WHEREAS, ENZON has developed a technology for coupling polyethylene glycol
("PEG") with polypeptides to create longer-acting therapeutic products; and
WHEREAS, SCHERING and ENZON have performed preliminary in vitro testing of a
compound made from Intron A and PEG and now desire, subject to the terms of this
Agreement, to further develop, test, conduct clinical trials of, and market the
resulting product; and
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WHEREAS the parties desire to enter into an agreement whereby ENZON shall
develop, under the terms of this Agreement, a longer-acting product in which
PEG is coupled with Intron A, develop scale-up and manufacturing procedures, and
manufacture such product for SCHERING, consistent with all applicable Good
Manufacturing Practices ("GMP's") and SCHERING shall, subject to the terms and
conditions of this Agreement, test, clinically develop and market worldwide, the
resulting Agreement Product as hereinafter defined;
NOW, THEREFORE, in consideration of the mutual premises and covenants set forth
below, the parties agree as follows:
Article 1 - Definitions
1.1 "Affiliate" shall mean any corporation or business entity controlled by,
controlling, or under common control with the respective party. For this purpose
"control" shall mean the direct or indirect beneficial ownership of at least
fifty percent (50%) of the voting stock of, or at least fifty percent (50%)
interest in the income of, such corporation or other business entity.
1.2 "Agreement Product" shall mean any pharmaceutical product in which Agreement
Substance as an active ingredient is coupled with PEG. The specifications for
the Agreement Product to be developed by SCHERING under this Agreement, in its
diluted form, will be set forth in Schedule A-3 hereto, which may be amended
from time-
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to-time, as mutually agreed by the parties hereto, or as needed to conform with
the IND (hereinafter defined) for Agreement Product. Agreement Product shall be
supplied to SCHERING by ENZON in the form of Bulk Concentrate, as hereinafter
defined.
1.3 "Agreement Substance" shall mean alpha interferon, including, without
limitation, the alpha interferon the specifications for which are set forth in
Schedule A-1 attached hereto (Specifications for Agreement Substance).
1.4 "Bulk Concentrate" shall mean Agreement Product in bulk concentrated form
meeting the criteria set forth in Schedule A-2 hereof. (Specifications for Bulk
Concentrate).
1.5 "Development Program" shall mean all development work undertaken by the
parties hereto with respect to Agreement Substance or Agreement Product,
relating to the development program for Agreement Product (Schedule B) hereto,
including the applicable objectives, protocols and timetables, by phases and
cumulatively, as well as any modifications to the development program set forth
[in Schedule B hereto made by Schering] in Schedule B hereto requested by either
party and accepted by the other party in writing, which acceptance shall not be
unreasonably withheld.
1.6 "FDA" shall mean the United States Food and Drug Administration or any
successor agency thereof, as well as any
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foreign equivalent thereof, including, where applicable, price-approval
authorities.
1.7 "FDA Approval" shall mean written notification of the approval (without
qualification which would materially adversely affect SCHERING's ability to
market Agreement Product) from the FDA of a PLA for Agreement Product for which
SCHERING seeks such approval, which allows SCHERING to commercially sell
Agreement Product.
1.8 (a) "Know-How" shall mean all confidential scientific, medical, and
technical data, instructions, processes, formulae, unpatented
inventions, expert opinion and information, whether written or
otherwise, necessary (as set forth in the PLA for Agreement Product)
for the development, manufacture, use or sale of Agreement
Substance, Bulk Concentrate or Agreement Product. Know-How shall
include, without limitation, all biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and
analytical, research, testing, safety, quality control,
manufacturing, marketing, test and clinical data and information
necessary (as set forth in the PLA for Agreement Product) for the
manufacture, use or sale of Agreement Substance, Bulk Concentrate or
Agreement Product. For purposes
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of this Agreement, Know-How shall not include any Know-How (as
defined in this Article 1.8(a)) which SCHERING can clearly
demonstrate was developed by SCHERING or its Affiliates without the
aid, application or use of any ENZON Existing or Development
Know-How (as hereinafter defined) or the participation of any
SCHERING employee or consultant who has knowledge of the contents of
such ENZON Existing or Development Know-How ("SCHERING Independent
Know-How"). Know-How also shall not include any information, data,
test result, study result, trial result, expert opinion or analysis
related to the pharmacology, toxicology, pharmacokinetics, clinical
trials or manufacturing steps to be taken by SCHERING, covered under
SCHERING'S PLA (hereinafter referred to as "SCHERING Information").
Know-How as defined in this subparagraph (a) is divided into the
three categories described below, and the two subcategories
described in Articles 4.1 and 4.2 hereof.
(b) "ENZON Existing Know-How" shall mean all Know-How owned or
controlled by ENZON or its Affiliates on or before April 3, 1990.
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(c) "SCHERING Existing Know-How" shall mean all Know-How owned or
controlled by SCHERING or its Affiliates on or before April 3, 1990.
(d) "Development Know-How" shall mean all Know-How developed by or on
behalf of either or both parties and/or their Affiliates under this
Agreement.
1.9 "IND" shall mean an Investigational New Drug Application or its foreign
equivalent, as required to be filed with the FDA.
1.10 "Net Sales" shall mean the proceeds actually received from sales of
Agreement Product in any country in the Territory by SCHERING or any of its
Affiliates or sublicensees to independent third party customers in bona fide,
arm's-length transactions, less:
(a) actual allowances for returns, damages or otherwise, and discounts,
rebates and allowances to customers, including cash, credit or free
goods allowances; and
(b) freight or other transportation charges, including insurance,
actually allowed or paid on account of the delivery of Agreement
Product to purchasers thereof; and
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(c) taxes (except income taxes) or duties paid, absorbed or otherwise
imposed on the sale, including, without limitation, value added
taxes.
1.11 "Patent Rights" shall mean: (a) all claims of any patent applications and
issued patents arising under this Agreement; and (b) any and all reissues,
extensions (or other governmental actions which provide exclusive rights to the
patent holder in the patented subject matter beyond the original patent
expiration date), substitutions, confirmations, registrations, revalidations,
additions, continuations, continuations-in-part or divisions of or to any of
the foregoing which are hereafter granted in the Territory. For purposes of this
Agreement, Patent Rights shall not include: (1) any patentable invention related
to the SCHERING Information, or (2) any patentable invention which SCHERING can
clearly demonstrate was invented or developed by SCHERING or its Affiliates,
without the aid, application or use of any ENZON Know-How (as hereinafter
defined) or the participation of any SCHERING employee or consultant who has
knowledge of the contents of the ENZON Know-How ("SCHERING Independent Patent
Rights"). The parties shall list Patent Rights as they arise in Schedule C
hereto, which shall be updated by the parties periodically to reflect changes in
the status of the Patent Rights.
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1.12 "PLA" shall mean a Product License Application, or its foreign equivalent,
as required to be filed with the FDA to obtain approval to sell the Agreement
Product.
1.13 "Territory" shall mean all countries of the world.
1.14 "Valid Claim" shall mean any claim contained in any pending patent
application or issued patent included within the Patent Rights, which has not
been abandoned or declared invalid in a non-appealable order, as the case may
be, and which would be infringed by the manufacture, use or sale of Agreement
Product in the absence of the licenses granted hereunder.
Article 2 - Development Program
2.1 The parties have agreed upon, and set forth in Schedules A-2 and A-3 hereof,
specifications and criteria for Bulk Concentrate and Agreement Product.
2.2 The parties have executed a Letter of Agreement dated April 3, 1990, wherein
ENZON agreed, inter alia, to provide SCHERING with a *** sample batch and
a *** production batch of Agreement Product in exchange for certain
payments.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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2.3 The parties have agreed upon, and set forth in Schedule B hereto, a
Development Program for Agreement Product. ENZON and SCHERING shall use diligent
efforts to carry out their designated responsibilities under the Development
Program in a timely fashion, except in those cases where a party has obtained
the prior written approval of the other to modify a portion of the Development
Program. The Development Program shall be reviewed from time-to-time as shall
be agreed by the parties hereto, and the terms thereof may only be changed as
mutually agreed in writing by the parties hereto or as suggested by the FDA
(with SCHERING's concurrence), or as ordered by the FDA. ENZON's obligations
under the Development Program are subject to its receipt of Agreement Substance
from SCHERING in a timely manner.
2.4 All trials for Agreement Product specified in the Development Program,
including any toxicological, pre-clinical or clinical trials that may be
required for drug registrations and approvals in the Territory, shall be the
responsibility of SCHERING. SCHERING shall use diligent efforts to obtain such
approvals and shall bear all costs of such trials; provided, however, that the
manufacture and supply of Agreement Product used in the trials referenced in the
Development Program shall be the responsibility of ENZON, but at SCHERING's sole
cost and expense, as set forth in Article 3.1 hereof, and subject to the
provisions of Article 2.8 and the other provisions of Article 3 hereof.
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2.5 Except as expressly provided otherwise herein, ENZON shall be solely
responsible for all direct and indirect costs and expenses of its employees,
agents, consultants, or subcontractors and for materials, plant and equipment
which ENZON employs or utilizes in carrying out its designated responsibilities
under the Development Program or in manufacturing Agreement Product for any
purpose hereunder.
2.6 The parties hereto shall keep each other informed of their progress with
respect to their respective responsibilities under the Development Program by
means of a quarterly written summary report in a form to be agreed upon by the
parties hereto. In addition, SCHERING will have access to ENZON's facilities to
observe progress of the Development Program, to the extent reasonably necessary
to successfully complete the Development Program, upon reasonable advance
notice. Each party hereto shall provide the other party with copies of all
Know-How in such other party's possession reasonably required in order to
enable SCHERING to obtain FDA Approval, including, without limitation, the
obligations of Article 2 hereof. Whenever reasonably feasible, such copies may
be given directly to the FDA rather than to the other party when in connection
with obtaining the FDA approval. ENZON shall, at SCHERING's reasonable request,
take all reasonable steps necessary to allow SCHERING to reference ENZON's Drug
Master File for Agreement Product; provided, however, that SCHERING shall not
have the right to have access to, view or have copies of
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ENZON's Drug Master File for Agreement Product. The right of reference and to
receive Know-How provided in this Article 2.6 shall not entitle SCHERING to use
or receive ENZON's Know-How for manufacturing the Agreement Product, except as
expressly permitted hereunder.
2.7 ENZON and SCHERING shall each designate one (1) senior development employee
as technical liaison to handle all technical matters and communications relating
to the Development Program.
2.8 SCHERING has provided ENZON with certain Know-How relating to the Agreement
Substance and shall provide ENZON with any additional Know-How in SCHERING's
possession as SCHERING and ENZON shall reasonably agree is required in
connection with ENZON's obligations under the Development Program.
2.9 SCHERING shall supply to ENZON in a timely fashion, at no cost, quantities
of Agreement Substance necessary to make the Agreement Product called for in the
Development Program and to manufacture Agreement Product as required under
Article 2.4 hereof. ENZON agrees to advise SCHERING, at least sixty (60) days in
advance of the requested delivery thereof, of its requirements for the Agreement
Substance.
2.10 SCHERING shall use its best efforts (comparable to efforts it uses with
other products of similar status) to file the
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foreign equivalent of a Product License Application for Agreement Product in at
least three (3) of the following countries: France, West Germany, Italy, Spain,
United Kingdom, Japan and Canada, within twelve (12) months after the submission
of the initial PLA in the United States of America for Agreement Product, and
similarly file in the remaining countries set forth in this Article 2.10 within
twenty-four (24) months after such submission.
2.11 ENZON shall deliver to SCHERING in a timely fashion sufficient Agreement
Product for SCHERING to carry out the activities contemplated by Article 2.4
hereof.
2.12 ***
2.13 During the term of this Agreement, anything to the contrary contained
herein notwithstanding, ENZON shall not develop any product containing PEG and
alpha interferon for itself or with or for any third party, nor shall it enter
into discussions or negotiations with any such third party concerning any
product containing PEG and alpha interferon.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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Article 3 - Manufacture of Commercial Quantities of Agreement Product; Know-How
Transfer
3.1 SCHERING shall notify ENZON, no later than the date of the first PLA filing,
that it intends to introduce Agreement Product into commerce. Upon such
notification, ENZON shall commence preparing to supply commercial quantities of
Agreement Product to SCHERING under a supply agreement (the "Supply Agreement")
executed by the parties concurrently with this Agreement and attached hereto as
Schedule E. SCHERING shall pay ENZON for Agreement Product to be supplied to
SCHERING for the Development Program and for commercial sales at the price
established pursuant to the terms of the Supply Agreement.
3.2 The provisions of Article 14 (Force Majeure) of this Agreement and Article
XIV (Force Majeure) of the Supply Agreement notwithstanding:
(a) The parties recognize the importance of an uninterrupted supply of
commercial quantities of Agreement Product to SCHERING under the
terms and conditions of the Supply Agreement. As soon as it shall
become apparent to ENZON that circumstances resulting in any failure
or delay in delivery hereunder, beyond the time period for timely
delivery set forth in Article III.D. of the Supply
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Agreement, will continue for more than sixty (60) days, ENZON shall
promptly notify SCHERING, in writing, of that fact and shall consult
with SCHERING as to the best practical method for assuring SCHERING
a source of supply of Agreement Product during the continuance of
such circumstances. Provided such failure or delay is not caused by
SCHERING's failure to deliver Agreement Substance in a timely manner
to ENZON or otherwise by SCHERING's breach of this Agreement, ENZON
shall provide SCHERING with all reasonable technical and other
assistance in this regard ("Manufacturing Assistance") including
disclosure of only such Know-How as may be reasonably necessary (as
set forth in the PLA for Agreement Product) for manufacturing or
quality control of Agreement Product. Manufacturing Assistance shall
include, without limitation: (1) designation by ENZON of a
third-party manufacturer acceptable to SCHERING, or (2) assisting
SCHERING or any of its Affiliates to manufacture its own
requirements of Agreement Product; such assistance by ENZON shall
continue only for so long as such circumstances continue. The
decision as to whether SCHERING or any of its Affiliates, or a third
party source, shall be designated to supply Agreement Product during
the
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time ENZON cannot do so directly, shall be made jointly by the
parties, taking into account the best interest of both the parties,
including factors such as (without limitation) cost, time required
to initiate production of commercial quantities, protection of
intellectual property rights, avoiding benefitting competitors,
regulatory requirements, quality control, etc.
(b) (1) ENZON shall be required to allow any manufacturing program for
Agreement Product initiated under this Article 3.2 to continue after
ENZON regains its ability to supply Agreement Product to SCHERING
hereunder only for so long as may be reasonably necessary for
SCHERING and/or any of its Affiliates to fully amortize any
incremental capital expenses it may have reasonably incurred under
such manufacturing program, using generally accepted accounting
principles normally used by SCHERING in keeping its own books and
records. Third-party sources designated by ENZON shall be acceptable
in view of the then-current health regulations.
(2) If the failure or delay first mentioned in Article 3.2(a) above
is the fault of ENZON and
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within its control, any additional cost of Agreement Product under
such manufacturing program, whether performed by SCHERING or any of
its Affiliates or any such third-party source, over the cost agreed
to by SCHERING in the Supply Agreement, will be borne by ENZON;
provided ENZON was afforded the opportunity to mitigate or reduce
such cost prior to it being incurred by SCHERING and/or any of its
Affiliates.
(c) ENZON shall have the option, in its sole discretion, to delete
Article 3.2 from this Agreement. If ENZON exercises this option and
so advises SCHERING in writing (the "Option Notice") as far in
advance as possible, taking into account the current inventory of
Agreement Product and the time required for SCHERING to arrange for
another source of Agreement Product, but in no case less than nine
(9) months (or such shorter period as may be mutually agreed upon by
the parties hereto) in advance of the effective date of the Option
Notice, then Article 3.2 shall be deleted and have no further
effect, as of the effective date of the Option Notice; provided,
however, that ENZON's obligation to provide Manufacturing Assistance
to SCHERING and the provisions of Article 3.2(c)(1) through (4)
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inclusive shall survive such deletion and continue until SCHERING
shall reasonably be capable of manufacturing Agreement Product (in
the manner set forth in the PLA for Agreement Product). In such
case, as of the effective date of such notice: (1) ENZON shall have
no right or obligation to thereafter supply Agreement Product to
SCHERING under this Agreement or the Supply Agreement, (2) ENZON
shall grant to SCHERING a paid-up license in the Territory, at no
additional cost to SCHERING, for the term of this Agreement, of all
Know-How necessary (as set forth in the PLA for Agreement Product)
and Patent Rights for manufacturing Agreement Product, (3) SCHERING
will have no further obligations to purchase Agreement Product from
ENZON, and (4) SCHERING shall waive and give up any right or claim
to damages or recoupment of expenses or costs which are based on
ENZON's failure or delay in supplying Agreement Product and which
arose under this Article 3.2; provided, however, ENZON shall
continue to be responsible, as set forth in 3.2(b)(1), for any
additional cost of Agreement Product manufactured during the nine
(9) month period between the date the Option Notice is given and the
effective date of the Option Notice. In any event, SCHERING shall be
required to pay ENZON
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royalties on Net Sales under Article 7 hereof in connection with all
Agreement Product manufactured under this Agreement.
Article 4 - Ownership of Intellectual Property; Exclusive Licenses
4.1 ENZON shall own the entire right, title and interest in and to the
Development Know-How related to Agreement Product and/or PEG, whether created
by SCHERING, by ENZON or jointly by the parties ("ENZON Development Know-How").
4.2 SCHERING shall own the entire right, title and interest in and to the
Development Know-How covering and related to Agreement Substance, whether
created by SCHERING, by ENZON or jointly by the parties ("SCHERING Development
Know-How").
4.3 ENZON shall own the entire right, title and interest in and to all Patent
Rights related to Agreement Product and/or PEG, whether invented by SCHERING, by
ENZON, or jointly by the parties hereto ("ENZON Patent Rights").
4.4 SCHERING shall own the entire right, title and interest in and to all Patent
Rights related to Agreement Substance, whether invented by ENZON, by SCHERING,
or jointly by the parties hereto (the "SCHERING Patent Rights").
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4.5 For all other Development Know-How and Patent Rights, the party that
invented or created same shall own the entire right, title and interest therein,
if the other party is not a joint inventor or creator thereof. If the parties
jointly invented or created same, they shall be joint owners thereof.
4.6 SCHERING shall own all right, title and interest in and to all SCHERING
Information.
4.7 Subject to the other terms of this Agreement, ENZON hereby grants to
SCHERING and SCHERING hereby accepts, exclusive licenses, exclusive even as to
ENZON, under the ENZON Patent Rights the ENZON Existing Know-How and the ENZON
Development Know-How, during the term of this Agreement: (1) to use and sell
Agreement Product in the Territory, with the right to sub1icense SCHERING's
Affiliates or third parties and (2) to make and have made Agreement Product,
with the right to sublicense SCHERING's affiliates, under the conditions stated
in Article 3.2 hereof.
4.8 Subject to the other terms of this Agreement and for the sole purpose of
ENZON's development and manufacture of Agreement Product for SCHERING, SCHERING
hereby grants ENZON the right, under the SCHERING Information, the SCHERING
Patent Rights, the SCHERING Existing Know-How, the SCHERING Development
Know-How, and the RC License (as hereinafter defined) during the term of this
Agreement, to use Agreement Substance in the development and manufacture of
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Agreement Product and to manufacture Agreement Product, except under the
condition referred to in Article 3.2(a)(2) hereof.
4.9 Upon expiration of this Agreement as provided in Article 9.1 hereof, either
in its entirety or with respect to any country in the Territory, ENZON shall
disclose to SCHERING and SCHERING and its Affiliates may use, either in the
Territory or in any such country, without any further payment, for any purpose
whatsoever related to Agreement Product (but not for any other purpose or other
product), all ENZON Patent Rights, ENZON Existing Know-How, and ENZON
Development Know-How.
4.10 No license or right of any sort shall arise under this Agreement, whether
by implication or estoppel, with respect to U.S. Patent 4,179,337 and its
foreign counterparts, nor to any patent or patent right with respect to
Agreement Substance, except as specifically set forth herein.
Article 5 - Patent Rights
5.1 With respect to Patent Rights, it is agreed:
5.1.1 ENZON shall diligently prosecute, maintain and defend all
patent applications and issued patents included within the ENZON
Patent Rights. All costs for patent filing, prosecution, and
maintenance of such
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Patent Rights shall be borne by ENZON. If ENZON chooses not to
defend such Patent Rights in any country against any third party,
then SCHERING may defend such Patent Rights in such country with
respect to such third party, at SCHERING's sole cost, and SCHERING
will retain for its own benefit any judgment therefrom. If such
defense is successful, SCHERING may thereafter deduct its reasonable
expenses (including attorney's fees) related to such defense (net of
any judgment monies received by SCHERING) from future royalties due
in such country under Article 7 hereof.
5.1.2 ENZON shall notify SCHERING immediately (i) whenever it files
a patent application related to the ENZON Patent Rights in any
country; and (2) whenever it is considering discontinuance of the
prosecution or maintenance of such a patent application. If ENZON
shall fail to file a patent application related to the ENZON Patent
Rights in any country it shall so notify SCHERING immediately in
writing, and if ENZON does not initiate the filing process within
ninety (90) days after written request to do so from SCHERING, or if
ENZON does not continue prosecution or maintenance of such a patent
application related to the ENZON Patent Rights which it has
initiated pursuant to Article 5.1.2 above within ninety (90) days
after written notice from SCHERING,
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SCHERING shall have the option to file or continue prosecution in
its own name and at SCHERING's cost. In either such case ENZON shall
do all acts necessary to assign and vest title to and transfer
control of such patent application in that country in a timely
fashion to SCHERING for no additional consideration.
5.1.3 Each party hereto shall notify the other party hereto of its
knowledge of any infringement of the Patent Rights within sixty (60)
days after becoming aware of such infringement.
5.1.4 With respect to SCHERING Independent Patent Rights, it is
agreed that SCHERING shall, no later than the date of filing of the
first patent application for any patentable invention included in
the SCHERING Independent Patent Rights, provide to ENZON on a
non-confidential basis a statement of the subject matter of such
patent application, using good-faith efforts to make such statement
as complete as possible without divulging any confidential or
proprietary information, it being understood that SCHERING shall not
be required to divulge any confidential or proprietary information
in such statement. Thereafter, ENZON may request, and SCHERING shall
provide, within twenty (20) days after ENZON's request, (under
appropriate conditions of confidentiality
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imposing restrictions on ENZON similar to those SCHERING requires
for its other confidential information) a copy of the contents of
such patent application.
Article 6 - Payments
6.1 Subject to the terms of this Agreement, SCHERING agrees to make the
following payments to ENZON in U.S. Dollars as indicated:
(a) One hundred and fifty thousand dollars ($150,000) within fifteen
(15) days after the date of execution by the last of the parties to
sign this Agreement.
(b) Four hundred fifty thousand dollars ($450,000) within fifteen (15)
days after SCHERING's filing of the first IND in the United States
of America for Agreement Product.
(c) Two million five hundred thousand dollars ($2,500,000) within
fifteen (15) days after confirmation of SCHERING's successful
completion ("Successful Completion") of the initial clinical trial
demonstrating that Agreement Product meets the criteria set forth in
Schedule D attached hereto (Criteria for Efficacy in Pilot Study).
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(d) One million dollars ($1,000,000) within fifteen (15) days after
SCHERING's submission of the first PLA for Agreement Product in the
United States of America.
(e) Two million dollars ($2,000,000) within fifteen (15) days after
receipt of the first FDA Approval to occur in the United States of
America.
(f) None of the foregoing payments shall be payable to ENZON more than
once under any circumstance.
6.2 If, upon completion of the clinical trial described in Article 6.1(c)
hereof, Agreement Product does not meet the applicable criteria set forth in
Schedule D, and SCHERING decides at that time to terminate this Agreement as
permitted by Article 9.2(b) hereof, ENZON shall promptly refund *** to SCHERING.
Article 7 - Royalty Terms
7.1 Subject to Article 7.2 below, SCHERING shall pay or cause to be paid
royalties to ENZON on Net Sales as follows:
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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(a) For as long as SCHERING pays a royalty, under the license agreement
dated December 3, 1987, between SCHERING and Research Corporation,
in connection with SCHERING's sale of an Agreement Product in any
country in the Territory, SCHERING shall pay ENZON a royalty in such
country of *** SCHERING shall provide to ENZON reasonable evidence
of such payments to Research Corporation at ENZON's request.
(b) In each calendar year during the term of this Agreement, in
connection with SCHERING's sales of Agreement Product which do not
require payment of a royalty under Article 7.1(a) above, if
Competition, as defined in Article 7.1(d) below, exists in any such
country, SCHERING shall pay ENZON a royalty *** for so long as the
sum of Net Sales in all countries in the Territory during such
calendar year *** and *** after the sum of Net Sales in all
countries in the Territory during such calendar year ***
(c) In each calendar year during the term of this Agreement, in
connection with SCHERING's sales of
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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Agreement Product which do not require payment of a royalty under
Article 7.1(a) above, if Competition does not exist in any such
country, SCHERING shall pay ENZON a royalty of *** for so long as
the sum of Net Sales in all countries in the Territory during such
calendar year does not ***, and *** after the sum of Net Sales in
all countries in the Territory during such calendar year ***
(d) For purposes of this Article 7, "Competition" shall mean sales by a
party or parties, other than SCHERING, its Affiliates, licensees,
distributors or agents, in any country of the Territory, of a
competitive product which contains alpha interferon (as a
significant active ingredient) coupled with PEG to produce a
longer-lasting product, ***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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or countries, there exists no effective patent or know-how
protection) and: (1) the sales of such competitive product made by
any one party equal *** or, (2) the sales of such competitive
product by two or more parties equal, with respect to each such
party, *** but, considering the sales of such competitive product
made by all such parties in the aggregate, equal ***
7.2 If SCHERING shall hereafter be required, in respect of its sale of Agreement
Product, to pay royalties (hereinafter "Third-Party Royalties") to any third
party whose patents may be infringed by such sales, SCHERING, in order to
reimburse itself for any such Third-Party Royalties, may deduct from royalties
due ENZON hereunder the net amount of any such Third-Party Royalties paid, but
in no event shall royalty due ENZON for any calendar quarter with respect to
Agreement Product be thereby reduced by reason of the provisions of this Article
7.2 to less than one-half of the royalty which would otherwise be due under the
other provisions of this Article 7. This Article 7.2 shall only apply if such
infringement is based on PEG coupled with Agreement Substance, and shall not
apply or be effective in connection with an infringement
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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related to Agreement Substance alone. ***
Article 8 - Royalty Payment Terms
8.1 Royalties payable hereunder with respect to Net Sales shall be paid
quarterly within sixty (60) days after the close of the calendar quarter during
which proceeds from such Net Sales were received. All royalty payments shall be
accompanied by SCHERING's statement of Net Sales, together with SCHERING's
royalty calculations.
8.2 Royalties shall be payable in and remitted in United States dollars, by
SCHERING or its appropriate Affiliate. If Net Sales are invoiced in other than
U.S. dollars, such Net Sales shall be converted to U.S. dollars in accordance
with generally accepted accounting principles (as employed by SCHERING in
translating its published financial results for SEC reporting purposes) at the
closing rates of exchange in effect on the last SCHERING business day of the
month prior to the month in which the invoice was issued. If, due to
restrictions or prohibitions imposed by national or international authority,
SCHERING is unable to make the conversions as aforesaid or SCHERING or
SCHERING's affiliates are
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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unable to make any such royalty payment, the parties shall consult with a view
to finding a prompt and acceptable solution and SCHERING will, from time to
time, deal with such monies as ENZON may lawfully direct. The parties shall use
diligent efforts to cause such royalties to be paid, without reduction, and in
any event SCHERING's ultimate obligation for such payments shall not be
eliminated.
8.3 If the royalties set forth herein are higher than the maximum royalties
permitted by the law or regulations in any country in the Territory, the royalty
payable for sales in such country shall be equal to the maximum permitted
royalty under such law or regulations. In such case, the parties shall take
whatever actions are legally permissible to pay the entire amount of such
royalty above the permitted amount to ENZON, such as by an increase in the
period of time during which royalties shall be paid by SCHERING hereunder.
8.4 If any taxes, withholding or otherwise, are levied by any taxing authority
in connection with accrual or payment of any royalties payable under this
Agreement, SCHERING or its Affiliate shall have the right to pay such taxes to
the local tax authorities on behalf of ENZON and the payment to ENZON of the net
amount due after reduction by the amount of such taxes, together with evidence
of payment of such taxes, shall fully satisfy SCHERING's royalty
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obligations under this Agreement. SCHERING shall give ENZON reasonable notice of
any such payment.
8.5 Royalties shall be due hereunder and calculated only on the final sale of
Agreement Product by SCHERING or any SCHERING Affiliate or SCHERING sublicensee
to independent third parties in arm's-length transactions. No multiple royalties
shall be payable upon account of the sale of Agreement Product, regardless of
whether more than one patent exists within the Patent Rights in any country or
countries in the Territory.
8.6 SCHERING shall keep complete and adequate records with respect to the sale
of Agreement Product and royalties payable hereunder. ENZON shall have the right
to have such records of SCHERING inspected and examined, at ENZON's expense, for
the purpose of determining correctness of royalty payments made hereunder. Such
inspection and examination shall be made by an independent certified public
accountant to whom SCHERING shall have no reasonable objection. Such accountant
shall not disclose to ENZON any information other than that necessary to verify
the accuracy of reports and payments made pursuant to this Agreement. It is
understood that such examination with respect to any quarterly accounting period
hereunder shall take place not later than two (2) years following the expiration
of the said period. No more than one examination per year shall take place.
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8.7 If, in order to facilitate direct royalty payments by a SCHERING Affiliate,
it is desirable that a separate license agreement be entered into between ENZON
and such Affiliate, ENZON agrees to grant such license directly to such
Affiliate by means of an agreement which shall be consistent with the provisions
of this Agreement.
Article 9 - Term and Termination
9.1 This Agreement shall be made effective on the date first written above and
shall continue in effect, unless terminated earlier as expressly provided
herein, for a term which shall expire, on a country-by-country basis, upon the
longer of (a) the life in each such country of the last to expire of the ENZON
Patent Rights for which a Valid Claim exists, including any patent extension (or
any other governmental action which has the effect of extending the period of
market exclusivity of the patent owner) which is permitted by law and obtained,
or (b) fifteen (15) years from the date on which Agreement Product is first
approved for commercial marketing in each such country ("Term").
9.2 SCHERING shall have the right to terminate this Agreement at any time,
either in its entirety or on a country-by-country basis:
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(a) after sixty (60) days' written notice to ENZON, if ENZON has not
cured the cause of such right to terminate if based upon this
Article 9.2(a), if the Agreement Product resulting from the
Development Program shall fail to meet the specifications and
criteria set forth in Schedule A-3;
(b) after the completion of the clinical trial set forth in Article
6.1(c) hereof; provided, however, that if Successful Completion, as
defined in Article 6.1(c) hereof shall have taken place, SCHERING's
right to terminate under this Article 9.2(b) shall be contingent
upon SCHERING's having made the payment set forth in Article 6.1(C)
hereof.
In the event of any termination by SCHERING hereunder, SCHERING shall be
required to make only those payments hereunder which have accrued and are due
and owing prior to the effective date of such termination.
9.3 Upon the failure of either party hereto to comply with any of its respective
material obligations contained herein, the other party shall be entitled,
without prejudice to any other rights conferred on it herein, to terminate this
Agreement upon not less than sixty (60) days notice of such default given to the
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defaulting party, provided that the party in defau1t has failed to cure such
default within such sixty (60) day period.
9.4 If either party hereto shall become insolvent or shall make an assignment
for the benefit of creditors, or proceedings in voluntary or involuntary
bankruptcy shall be instituted in behalf of or against such party, or a receiver
or trustee of such party's property shall be appointed, the other party hereto
may, without other action or notice, forthwith terminate this Agreement.
9.5 Except as otherwise provided herein, in the event of termination under
Articles 9.2, 9.3 or 9.4, each party shall return to the other party, and no
longer use for any reason or purpose, all the Know-How belonging solely to the
other party.
Article 10 - Representations and Warranties; Indemnification
10.1 ENZON hereby represents and warrants that it has sole, full and complete
right, title and interest in all Patent Rights and ENZON Existing Know-How.
ENZON further represents and warrants that, to the best of its knowledge as of
the effective date of this Agreement, the manufacture, use or sale of Agreement
Product by ENZON will not infringe any third party's patent rights related to
Agreement Product or PEG. ENZON shall fully indemnify, defend and hold SCHERING
harmless for all direct damages and expenses, including reasonable attorney's
fees, (but not for consequential
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damages such as lost or reduced profits, royalties, or similar items) which may
be incurred by SCHERING for any breach of the warranties contained in this
Article 10.1, but not if such infringement is related to the Agreement
Substance.
10.2 Each party hereto represents and warrants that it has the right to enter
into this Agreement and has no obligation, or knows of no obstacle, which would
prevent either party from carrying out its obligations and responsibilities
thereunder, including manufacture, commercialization and/or sale of Agreement
Product on a world-wide basis.
10.3 SCHERING represents and warrants that the use by ENZON of Agreement
Substance supplied by Schering to ENZON only in connection with ENZON's
activities under this Agreement and the Supply Agreement will not infringe the
patent rights and/or know-how rights of any third party with respect to
Agreement Substance. SCHERING further represents and warrants that, to the best
of its knowledge as of the effective date of this Agreement, it has: (a) the
right to make, have made, use and sell: (1) alpha interferon, and (2) under a
license agreement with Research Corporation dated December 3, 1987, in
connection with U.S. Patent 4,179,337 and its foreign counterparts (the "RC
License"), products combining PEG and alpha interferon; and (b) the right to
make the grants to ENZON contained in Article 4.8 hereof. SCHERING shall fully
indemnify, defend and hold ENZON harmless for all direct damages and expenses,
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including reasonable attorney's fees, (but not for consequential damages such as
lost or reduced profits, royalties, or similar items) which may be incurred by
ENZON for any breach of the warranties contained in this Article 10.3.
10.4 SCHERING shall indemnify, defend and hold ENZON harmless from and against
any and all claims, including reasonable attorney's fees, for loss, damages, or
injury to persons or property by whomsoever raised, arising out of SCHERING's
negligence in manufacturing, marketing, distribution and sale of Agreement
Substance or Agreement Product.
10.5 In addition to the warranty set forth in Article 10.1 above, ENZON shall
indemnify, defend and hold SCHERING harmless from and against any and all
claims, including reasonable attorney's fees, for loss, damages, or injury to
persons or property by whomsoever raised, arising out of ENZON's negligence in
the development, testing or manufacture of Agreement Substance or Agreement
Product.
10.6 The coverage of Articles 10.4 and 10.5 above shall not be deemed to extend
to the infringement of any patent right.
10.7 (a) ENZON shall provide to SCHERING, no later than thirty (30) days
after the date first written above, a certificate of insurance
evidencing liability
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insurance, including products liability and contractual liability
insurance, covering ENZON's obligations under this Agreement, and
satisfactory to SCHERING, in the amount of one million dollars
($1,000,000). Such insurance shall be kept valid and in full force
by ENZON until the initiation of Phase III clinical trials of
Agreement Product by SCHERING hereunder, and ENZON shall provide
SCHERING with certificates of renewal or re-issuance as they become
available.
(b) ENZON shall provide to SCHERING, no later than thirty (30) days
after the initiation of Phase III clinical trials of Agreement
Product by SCHERING hereunder, a certificate of insurance evidencing
liability insurance, including products liability and contractual
liability insurance, covering ENZON's obligations under this
Agreement, and satisfactory to SCHERING, in the amount of five
million dollars ($5,000,000), hereinafter the "Face Amount". Such
insurance shall be kept valid and in full force by ENZON during the
term of this Agreement, and ENZON shall provide SCHERING with
certificates of renewal or re-issuance as they become available;
provided, however, that during any period in which the cost to ENZON
of the insurance
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required under this Article 10.7(b) reasonably shall be greater than
one hundred fifty percent (150%) of the adjusted cost ("Adjusted
Cost") to ENZON of such insurance during the first full year such
insurance was in effect, the Face Amount shall be reduced to an
amount which ENZON reasonably can purchase for a sum equal to one
hundred fifty percent (150%) of the Adjusted Cost. The Adjusted Cost
in each year shall be determined by applying to the prior year's
Adjusted Cost (or for the second year such insurance shall be in
effect, the prior year's actual cost) the percentage increase or
decrease in the U.S. gross national product shown in the final
annual Implicit Price Deflator for Gross National Product table
produced for the prior calendar year by the Bureau of Economic
Analysis of the U.S. Department of Commerce (or any successor agency
thereof).
(c) Failure to demonstrate such proof of valid, in-force, insurance
coverage, or failure to maintain such coverage, shall be grounds for
immediate termination of this Agreement by SCHERING.
10.8 The aforesaid obligations of the indemnifying party shall be subject to the
indemnified party fulfilling the following obligations:
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(a) The indemnified party shall bring any claim, action, damage,
expense, etc. to the attention of the indemnifying party as soon as
reasonably possible;
(b) The indemnified party shall fully cooperate with the indemnifying
party in the defense of any claims, actions, etc., which defense
shall be controlled by the indemnifying party (provided, however,
that the indemnified party shall be entitled to counsel at its own
expense) ;
(c) The indemnified party shall not, except at its own cost, voluntarily
make any payment or incur any expense with respect to any claim or
suit without the prior written consent of the indemnifying party,
which such party shall not be required to give.
Article 11 - Confidentiality
11.1 Both ENZON and SCHERING recognize that Know-How disclosed by each party to
each other, including ENZON Existing Know-How, ENZON Development Know-How,
SCHERING Existing Know-How, SCHERING Development Know-How, and any
jointly-owned Development Know-How, is of proprietary value to and is to be
considered highly confidential and shall be treated by the parties during the
term of this
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Agreement (or any extension thereof) and for a period of five (5) years after
the expiration or any termination thereof in the following manner:
(a) SCHERING agrees to keep confidential and not to disclose to others,
without the express written permission of ENZON, ENZON Existing
Know-How, ENZON Development Know-How, and any jointly-owned
Development Know-How.
(b) ENZON agrees to keep confidential and not to disclose to others,
without the express written permission of SCHERING, SCHERING
Existing Know-How, SCHERING Development Know-How, and any
jointly-owned Development Know-How.
11.2 Neither party shall be prevented from disclosing any Know-How which:
(a) can be demonstrated by written records to have been known to the
recipient at the time of receipt, or
(b) was subsequently otherwise legally acquired by such party from a
third party having an independent right to disclose the Confidential
Information, or
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(c) which was at the time of disclosure, is now or later becomes
publicly known without breach of this Agreement by either party, or
(d) which is required to be disclosed by law, regulation, or act of any
governmental agency.
11.3 Anything to the contrary in Article 11.1. above notwithstanding, SCHERING
and its Affiliates shall be permitted to disclose Know-How to:
(a) regulatory agencies in support of applications to market Agreement
Product;
(b) clinicians or others in connection with research related to such
applications, or to the preparation or filing of such applications,
provided, however, that SCHERING shall use diligent efforts to
secure signed confidentiality agreements prior to any disclosure
under this Article 11.3(b); and
(c) distributors as reasonably necessary for purposes of obtaining
approval to market Agreement Product or to market or promote
Agreement Product, provided, however, that SCHERING shall use
diligent efforts to
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secure signed confidentiality agreements prior to any disclosure
under this Article 11.3(c).
11.4 Upon the expiration or any termination of (but not during) this Agreement
except termination for cause by SCHERING under the terms of Articles 9.3 and 9.4
hereof), ENZON shall have the right to disclose to potential licensees, under
appropriate confidentiality restrictions similar to those ENZON normally uses
for the disclosure of its own valuable proprietary information, summaries of the
SCHERING Information (but not the underlying data or the tests or analyses
themselves). These disclosures, however, may not contain any proprietary
information pertaining to Agreement Substance.
11.5 During the term of this Agreement, SCHERING and its Affiliates may use
ENZON Patent Rights, ENZON Existing Know-How, and ENZON Development Know-How for
any purpose whatsoever related to Agreement Product (but not for any other
purpose or other product) only pursuant to Article 4.7 hereof. This clause 11.5
shall not be deemed to impose any requirement for ENZON to disclose Know-How
except as otherwise expressly provided in this Agreement.
Article 12 - Governing Law
This Agreement shall be governed by and interpreted in accordance with the
substantive law of the State of New Jersey, without regard to its choice of law
principles.
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Article 13 - Assignment or Delegation
13.1 Except as provided in Article 13.2 below, neither party may without written
approval of the other:
(a) assign this Agreement or transfer its interest or any part thereof
under this Agreement to any third party, or
(b) designate and cause any third party to perform all or part of its
activities hereunder, or to have the benefit of all or part of
its rights hereunder, except that ENZON may continue to have that
portion of its manufacturing operation which is being performed by
other parties as of the date of this Agreement continue to be so
performed.
13.2 Either party hereto may assign this Agreement, without the other party's
consent, to a third party in a transaction in which all the assets of the
assigning party relating to Agreement Product are sold or assigned; provided
such third party was not selling a product competitive to the Agreement prior to
such assignment.
In the event of any such permitted assignment, transfer or designation, the
assignee, transferee or designee shall assume and be bound by the provisions of
this Agreement.
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Article 14 - Force Majeure
14.1 Except as otherwise provided in Article 3.2 hereof, neither party hereto
shall be liable in damages for, nor shall this Agreement be terminable or
cancellable by reason of, any delay or default in such party's performance
hereunder if such default or delay is caused by events beyond such party's
reasonable control, including, but not limited to, acts of God, regulation or
law or other action or failure to act of any government or agency thereof
(including, without limitation, any action or inaction of the FDA), war or
insurrection, civil commotion, destruction of production facilities or materials
by earthquake, fire, flood or storm, labor disturbances, epidemic, or failure of
suppliers (including each of SCHERING and ENZON with respect to their obligation
to supply the other), public utilities or common carriers; provided however,
that the party seeking relief hereunder shall immediately notify the other party
of such cause(s) beyond such party's reasonable control.
14.2 Each party shall endeavor to resume its performance hereunder as quickly as
possible if such performance is delayed or interrupted as set forth in Article
14.1 above.
Article 15 - Independent Contractor; Publicity
15.1 It is understood that both parties hereto are independent contractors and
engage in the operation of their own respective
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businesses and neither party hereto is to be considered the agent of the other
party for any purpose whatsoever. Each party shall be fully responsible for its
own employees and consultants, and the employees of one party shall not be
deemed to be employees of the other party for any purpose whatsoever.
15.2 Both parties agree not to use or refer to, without the other party's
written permission, which shall not be unreasonably withheld, the other's name
or agreements with the other party, or the terms of this Agreement, in any
public statement, whether oral or written, including, but not limited to,
communications with the media, or prospectuses; provided, however, that either
party may, without the consent of the other party, make whatsoever disclosure is
required by law, and particularly by the Securities and Exchange Act of 1934, as
amended, the regulations promulgated thereunder, and any applicable NASDAQ
rule. The parties agree that the press release attached hereto as Schedule F may
be made public.
15.3 Except as allowed under Article 15.2 above, ENZON shall not, without the
written permission of SCHERING's Vice-President, Business Development, publish
or report any information related to Agreement Substance or Agreement Product,
such approval shall not unreasonably be withheld, and shall be deemed to have
been given unless notice in writing to the contrary has been given to ENZON
within sixty (60) days from receipt by SCHERING of a request to approve such
publication or report.
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Article 16 - No Inconsistent Obligations
Each party hereto represents and warrants that it has no obligations or
commitments inconsistent with this Agreement and that it knows of no reason the
Development Program may not proceed as set forth in Schedule B hereto.
Article 17 - Severability; Survival
(a) Should any part of this Agreement be held unenforceable or in
conflict with the applicable laws or regulations of any
jurisdiction, the invalid or unenforceable part or provision shall
be replaced with a provision which accomplishes, to the extent
possible, the original business purpose of such invalid or
unenforceable part or provision in a valid and enforceable manner,
and the remainder of this Agreement shall remain binding upon the
parties hereto.
(b) The terms of this Agreement which by their intent or meaning have
validity beyond the term of this Agreement shall survive the
termination or expiration of this Agreement.
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Article 18 - Captions
18.1 The captions of this Agreement are solely for the convenience of reference
and shall not affect its interpretation.
18.2 Schedules X-0, X-0, X-0, X, X, X, X and F are attached to and made a part
of this Agreement.
Article 19 - Waiver
The failure of either party at any time to times or enforce or require
performance of any provision of this Agreement shall in no way operate as a
waiver or affect the right of such party at a later time to enforce the same. No
waiver by either party of any condition or the breach of any term or agreement
contained in this Agreement, whether by conduct or otherwise, in any one or more
instances, shall be deemed to be or shall be construed as a further or
continuing waiver of any such condition or breach, or a waiver of any other
condition or of any other breach of any other term contained in this Agreement.
Article 20 - Notice
Any notice, payment, report or other correspondence (hereinafter collectively
referred to as "Correspondence") required or permitted to be given hereunder
shall be sent by certified mail, by telefax
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or delivered by hand to the party to whom such Correspondence is required or
permitted to be given hereunder. Any such Correspondence shall be deemed to be
received upon receipt as evidenced by the written and dated receipt signed by
the receiving party or its agent or employee, or as evidenced by telefax
records.
All Correspondence to ENZON shall be addressed as follows:
Enzon, Inc.
00 Xxxxxxxx Xxxx
Xxxxx Xxxxxxxxxx, XX 00000-0000
Attention: Vice President, Corporate Development
with a copy to: General Counsel, Law Department
All Correspondence to SCHERING shall be addressed as follows:
Schering Corporation
0000 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Attention: Vice President, Business Development
with a copy to: Legal Director, Research and Licensing
Any entity may change the address to which correspondence to it is to be
addressed by notification as provided herein.
Article 21 - Entire Agreement
This Agreement, including Schedules A through F attached hereto, and the Letter
Agreement between the parties dated April 3, 1990, (the "Letter Agreement")
represent the entire understanding between the parties with respect to the
subject matter hereof, and supersede all other prior agreements, negotiations,
understandings, representations, statements and writings between the parties
relating thereto. No modification, alteration, waiver or change in
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any of the terms of this Agreement shall be valid or binding upon the parties
hereto unless made in writing and duly executed by each of the parties hereto.
In the event of any conflict between this Agreement and the Letter Agreement,
this Agreement shall control.
IN WITNESS WHEREOF, this Agreement has been executed by the parties to be
effective as of the day and year first written above.
--------------
APPROVED AS TO
LEGAL FORM
[INITIALS]
--------------
ENZON, INC. SCHERING CORPORATION
By: /s/ Xxxxxxx By: /s/ Xxxxxx X.
--------------------------- ---------------------------------
Title: President and CEO Title: President, Pharmaceuticals
------------------------ -------------------------------
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APPENDIX I
Initial Specifications for Agreement Substance
TEST SPECIFICATION
---- -------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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APPENDIX II
Additional Specifications for Agreement Substance
TEST SPECIFICATIONS
---- --------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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SCHEDULE A-1
SPECIFICATIONS FOR AGREEMENT SUBSTANCE
(SCM 30500 Drug Substance in Solution)
TEST SPECIFICATION
---- -------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
10/19/90
E-99
SCHEDULE A-2
SPECIFICATIONS FOR BULK CONCENTRATE
(PEG-SCH 30500 in Solution)
TEST SPECIFICATION
---- -------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
10/19/90
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SCHEDULE A-3
SPECIFICATIONS FOR AGREEMENT PRODUCT
(Modified PEG-Intron A Solution, 50x10^6 IU/ml.)
TEST SPECIFICATION
---- -------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
10/19/90
E-101
SCHEDULE B
SCH 30500--PEG INJECTION
DEVELOPMENT PLAN
START/
COMPLETION
ACTIVITY TARGET RESPONSIBILITY
------------------------------------- ----------- --------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
10/10/90
E-102
-2-
START/
COMPLETION
ACTIVITY TARGET RESPONSIBILITY
------------------------------------- ----------- --------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-103
-3-
START/
COMPLETION
ACTIVITY TARGET RESPONSIBILITY
------------------------------------- ----------- --------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-104
PROJECTED NDA TIMELINE
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-105
SCHEDULE C
PATENT RIGHTS
(To be updated by the parties as required under Article 1.11.]
10/25/90:1
E-106
SCHEDULE D
CRITERIA FOR DEMONSTRATING EFFICACY
IN A PILOT CLINICAL STUDY
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
10/10/90
E-107
SCHEDULE E
SUPPLY AGREEMENT
[omitted no longer in effect]
E-108
Amendment No. 1 December 10, 1991
FILE COPY
SCHERING CORPORATION J.M.K. SEP 23 0000
XXXXXXXXX XXXX XXXX [LOGO] KENILWORTH, N.J 07033
CABLES: SCHERING KENILWORTH
TELEX: 138315
138280
TELEPHONE: (000) 000-0XXX
September 16, 1991
Enzon, Inc.
00 Xxxxxxxx Xxxx
Xxxxx Xxxxxxxxxx, XX 00000-0000
ATTN: Xxxxx Xxxx
Dear Xx. Xxxx:
Pursuant to Article 1.5 of our Development, License and Supply Agreement
(the "Agreement"), dated November 14, 1990, this will confirm our agreement to
amend the Development Plan, as defined in the Agreement, in accord with the
attached memo from X. Xxxxx, dated April 29, 1991, and with the amended Schedule
B to the Agreement, both of which are attached hereto.
Please indicate your acceptance of the foregoing by signing one copy of
this letter as indicated below and returning it to us for our files.
Very Truly yours,
SCHERING CORPORATION ---------------
APPROVED AS TO
LEGAL FORM
By: /s/ Xxxxxxx X. Xxxxxxx
-------------------------- [INITIALS]
Xxxxxxx X. Xxxxxxx LAW DEPT
Vice President ----------------
Business Development
Accepted and Agreed:
ENZON, INC.
By /s/ Xxxxx X. Xxxx Xxxxx X. Xxxx
----------------------------------------
Title Vice President Corporate Development
Date 12/10/91
C/ADAG2691
cc: Xxxx Xxxxxx, Esq. (Enzon)
Xxxxx Cast
Xxx Xxxxxx
E-109
[LOGO] Schering-Plough Memo
Meeting Attendees Date: April 29, 1991
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-110
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
/s/ Xxxxxxx X. Xxxxx
-----------------------------
MAZ/nf Mtg(2)
Attachment
E-111
ATTACHMENT VII
SCHEDULE B
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-112
-2-
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-113
-3-
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-114
Amendment No. 2 October 30, 1992
[Amendment No. 2 is no longer in effect and therefore is not included in this
filing]
E-115
Amendment No. 3 March 1993
[Amendment No. 3 is no longer in effect and therefore is not included in this
filing]
E-116
Amendment No. 4 June 30, 1995
[LOGO] ENZON, Inc.
=========================================================================
June 30, 1995
Schering Corporation
0000 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Gentlemen:
This letter sets forth the terms and conditions under which Schering
Corporation (hereinafter called "SCHERING") and Enzon, Inc. (hereinafter called
"ENZON") agree to further amend their Development, License and Supply Agreement
dated November 14, 1990 (hereinafter the "Agreement"). Except as stated
otherwise in this letter amendment, capitalized words used herein shall have the
same meaning as those defined in the Agreement. A "Stock Purchase Agreement"
between the parties is effective concurrently with this letter amendment. This
letter amendment is effective June 30, 1995.
The Agreement shall be amended as follows:
Amendment 1
Under the March 2, 1993 letter amendment to the Agreement, paragraph 6, SCHERING
decided to continue development of an "Optimal Formulation" and ENZON provided
SCHERING with several batches of such Optimal Formulation. Additionally,
SCHERING elected to similarly pursue a second "Optimal Formulation" through the
filing of an IND. No additional payment is due ENZON pursuant to Article 6.1(b)
of the Agreement in connection with the second Optimal Formulation and all
payments required under the March 2, 1993 letter amendment to the Agreement have
been made by SCHERING.
================================================================================
00 Xxxxxxxxxxx Xxxx Xxxxxxxxxx, XX 00000-0000 (000) 000-0000
FAX: (000) 000-0000
E-117
Amendment 2
Schedules A-1, A-2, B, C, and D, which were attached to the Agreement and part
thereof on November 14, 1990, are hereby deleted and replaced by the new
schedules of that same designation, which are attached to this letter amendment.
Schedule A-3 is deleted and when SCHERING develops new and final specifications
they will be put into the Agreement as a new Schedule A-3. Further, new
Schedules G and H are attached to and made a part of this letter amendment. All
references below to Schedules, and future interpretation of this letter
amendment and the Agreement, shall be made with respect to these new Schedules.
Amendment 3
In Article 1.2, delete -- ENZON -- and -- are -- in the fourth line and replace
them, respectively, with -- SCHERING -- and -- will be --. Add at the end of
Article 1.4, -- SCHERING may amend the specifications in Schedule A-2 after the
effective date of this letter amendment if in its reasonable judgment it is
necessary to do so. ENZON shall not be responsible for such specifications as
amended unless it chooses to supply Bulk Concentrate pursuant to Article
3.1, --.
Amendment 4
In Article 1.5, strike the last three lines and insert -- in Schedule B hereto
made by SCHERING -- .
Amendment 5
In Article 2.3, delete -- ENZON and -- in the second line and delete the last
sentence in this Article. Further, insert therein
2
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-- Neither party will unreasonably withhold consent to changes in the
Development Program --.
Amendment 6
In Article 2.4, strike the last six lines and insert -- approvals and bear all
costs of such trials, including the manufacture and supply of Agreement Product
used in the trials referenced in the Development Program --.
Amendment 7
Delete Article 2.6 and insert the following:
"The parties hereto shall keep each other informed of their activities
hereunder and the status of the Development Program by means of a
quarterly written summary report, a form to be agreed upon by such
parties. ENZON shall, at SCHERING'S reasonable request, take all
reasonable steps necessary to allow SCHERING to reference ENZON'S drug
master file for Agreement Product, which exists as of the effective date
of this letter amendment, but have no obligation to hereafter add to or
modify it, except any obligation which may arise from the exercise by
ENZON of it's option rights to supply SCHERING'S United States
requirements for Bulk Concentrate under Article 3.1."
Amendment 8
In Article 2.8 strike the last three lines and insert -- any additional Know-How
in SCHERING'S possession as SCHERING shall determine is required under the
Development Program --.
3
E-119
Amendment 9
Delete the present Article 2.9. Insert therein -- SCHERING shall supply to ENZON
in a timely fashion, at no cost, quantities of Agreement Substance necessary to
make the Bulk Concentrate called for under Article 3.1.--
Amendment 10
Delete Article 2.11.
Amendment 11
***
Amendment 12
Delete Articles 3.1 and 3.2 and insert the following:
"3.1 SCHERING shall notify ENZON when it receives FDA approval for
Agreement Product no later than ten (10) days after such receipt. During
the two year period after the date of such FDA approval, ENZON shall have
the exclusive option, even as to SCHERING, to elect to manufacture for
SCHERING and its Affiliates and their sublicensees all of their
requirements for Bulk Concentrate to be sold in the U.S. during the Term
of this Agreement. If ENZON elects to supply such Bulk Concentrate, ENZON
shall supply, and SCHERING shall purchase, such Bulk Concentrate under the
terms and conditions of the "Supply Agreement" attached as Schedule
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
4
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E to the Agreement. ENZON shall not have to supply, and SCHERING shall not
have to accept, Bulk Concentrate before seven months have expired since
the giving of such notice."
"3.2(a) In consideration of the payments made by SCHERING to ENZON under
the June 30, 1995 letter amendment, ENZON shall promptly transfer after
June 30, 1995 previously undisclosed Know-How, owned and controlled by
ENZON as of June 30, 1995, which is necessary to acquire polyethylene
glycol("PEG") from third party vendors for conversion to Bulk Concentrate
and to manufacture Bulk Concentrate, and to obtain regulatory approvals to
manufacture Bulk Concentrate and Agreement Product and to market Agreement
Product. This transfer is being made by ENZON for the sole purpose of
SCHERING developing, and obtaining FDA approval to manufacture, market and
sell the Bulk Concentrate and Agreement Product. SCHERING shall use such
Know-How only as necessary for such purposes. It is the intention of the
parties that such Know-How not in any way be used for or relied on by
SCHERING to independently develop its own technology for combining PEG
with polypeptide. Further to the obligations specified in Article 11,
SCHERING will not disclose such ENZON Know-How to any party other then a
SCHERING Affiliate, a government authority required to approve the
registration or sale of Agreement Product, or a vendor producing PEG for
SCHERING provided such vendor has an obligation of confidentiality to
SCHERING in connection
5
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therewith. Further, SCHERING shall only disclose or allow access of such
ENZON Know-How to only those persons described above in this Article
3.2(a) who need such knowledge or access, as strictly interpreted, in
connection with the above stated purposes. As stated in Article 1.8(a) in
connection with SCHERING Independent Know-How, in the event SCHERING shall
develop any idea, invention or technology for combining PEG or any other
polyalkyleneoxide with any polypeptide, chemical or other compound the
presumption shall be that such development occurred, was based on and
originated out of such ENZON Know-How, unless SCHERING can reasonably
clearly demonstrate that it was developed by SCHERING or its Affiliates
without the aid, application, or use of such ENZON Know-How or the
participation of any SCHERING employee or consultant who had knowledge of
such Know-How. Further the second last sentence in Article 1.8(a)
relating to "SCHERING Information", shall be modified and interpreted to
exclude such ENZ0N Know-How or steps taken by SCHERING based on such
ENZON Know-How."
"3.2(b) ENZON shall transfer to SCHERING the Know-How referred to in
Article 3.2(a) promptly after June 30, 1995, generally in accordance with
the time table set forth in new Schedule G attached to and made a part of
the June 30, 1995 letter amendment. It is the intention of the parties
that ENZON provide to SCHERING, for example, but not by way of limitation
on SCHERING, the "recipe" for making and testing the Agreement Product,
6
E-122
but not ENZON's thought processes, theories, or reasons that led to such
recipe. Further, as an example only, ENZON shall provide SCHERING with its
standard operating procedures, batch records and raw material in-process,
final release assay protocols and available assay validations used in
connection with Agreement Product. However, ENZON shall not transfer to
SCHERING any of the information or documentation that led to ENZON's
selection or arrangement of the steps or information in these items.
Notwithstanding the remainder of this Article 3.2(b), such Know-How
shall include all elements of ENZON'S thought processes, theories or
reasons or previously referred to steps or information which ENZON relied
on in the manufacture of Bulk Concentrate. The foregoing limitations on
ENZON'S disclosure of such Know-How to SCHERING shall not apply to any of
such Know-How which is necessary to be disclosed to a government agency
for approval by that agency to manufacture Bulk Concentrate and / or sell
Agreement Product, provided such disclosure is done under confidentiality.
"3.2(c) Schedule G, entitled "Information Needed and Activities To Be
Completed For Transfer Of Know-How", lists particular information and
documents which ENZON shall transfer to SCHERING relating to the Know-How
described in Article 3.2 (a), but is not all inclusive of such Know-How.
In connection with the transfer of such Know-How to SCHERING under Article
3.2(b) ENZON will also provide to SCHERING and its Affiliates, and their
7
E-123
designees with regard to PEG and manufacture of Bulk Concentrate meeting
specifications included in Schedule A-2 as of June 30, 1995, reasonable
technical assistance in utilizing such Know-How. SCHERING shall pay
ENZON's reasonably documented out of pocket expenses for such assistance.
Further, upon completion or transfer of such information and documents and
of the activities specified in Schedule G, SCHERING shall make the One
Million Dollar($1,000,000) payment to ENZON described in "Amendment 15"
of the June 30, 1995 letter amendment."
Amendment 13
In Article 4.7, in the third line, delete -- licenses -- and insert -- license
--. Further, delete the last five lines and insert -- during the Term of this
Agreement, to make, have made, use and sell Bulk Concentrate and Agreement
Product in the Territory. This license shall include the right to sublicense
SCHERING'S Affiliates, with respect to making and having made the Bulk
Concentrate and Agreement Product, third party vendors with respect to the
manufacture of conforming PEG and its Affiliates or third parties, with respect
to using and selling Agreement Product. Notwithstanding the exclusive license
granted under the previous sentence, ENZON shall retain the right to manufacture
and supply Agreement Product to SCHERING under the terms and conditions covered
under Article 3.1, if ENZON exercises its option under that Article --.
Amendment 14
In Article 4.8, delete the first two lines on page 20 and insert --
8
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Bulk Concentrate and to manufacture Bulk Concentrate, under the terms and
conditions specified in Article 3.1 -- . In Article 4.9, in the sixth line, add
-- Bulk Concentrate or -- before the words -- Agreement Product --.
Amendment 15
In addition to the batches of Bulk Concentrate covered under the March 2, 1993
amendment to the Agreement sold to SCHERING, ENZON has delivered eleven (11)
batches of such Bulk Concentrate to SCHERING for total of eight hundred
eighty-five thousand dollars ($885,000), which SCHERING has paid to ENZON. In
addition to the payments called for under Article 6.1(a) - (f), SCHERING shall
also pay ENZON two million dollars ($2,000,000) within twenty(20) days after the
effective date of this letter amendment and a further additional one million
dollars ($1,000,000) on the completion of the transfer of Know-How from ENZON to
SCHERING covered under Article 3.2(c) of this letter amendment.
Amendment 16
Delete the Article 6.1 (C) and add the following
"(c) One million dollars ($1,000,000) within ten days after dosing the
first patient enrolled in the Phase 2 Clinical Trial, as that phase is described
in the Development Program (as per Schedule D(a)) and one million five hundred
thousand dollars ($1,500,000) within ten days after SCHERING's initiation of
large scale clinical trials as described in Schedule D(b)."
Amendment 17
In Article 9.2(a), in the third line, after --, -- delete the
9
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ba1ance of Article 9.2(a) and insert the following:
"if any of the requirements specified in new Schedule H attached hereto
and made a part of the June 30, 1995 letter amendment are not met or."
Delete Article 9.2 (b) and insert the following:
" after completion of the initial clinical trial demonstrating that
Agreement Product meets the criteria set forth in Schedule D attached
hereto; provided, however, that if such successful completion shall have
taken place, SCHERING'S right to terminate under this Article 9.2 (b)
shall be contingent upon SCHERING'S having made to ENZON the total
payments of *** set forth in Article 6.1(c)."
Amendment 18
In Article 10 add the following new representations and warranties:
"10.9 As of June 30, 1995, ENZON and it's subsidiaries are each a
corporation duly organized and existing in good standing under the laws of
the jurisdiction of their incorporation, except, in the case of such
subsidiaries, as would not have a Material Adverse Effect(as defined
below), and has the requisite corporate power to own its properties and
carry on its business as now being conducted. ENZON and it's subsidiaries
are each duly qualified to do business and in good standing in every
jurisdiction in which the nature of the business conducted or property
owned by them makes such
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
10
E-126
qualification necessary and where the fai1ure so to qualify would have a
Material Adverse Effect. "Material Adverse Effect" means any material
adverse effect on the operation, properties or financial condition of
ENZON and it's subsidiaries taken as a whole."
"10.10 As of June 30, 1995 ENZON has the requisite corporate power and
authority to enter into and perform its obligations under the 1995 letter
amendment, the execution and delivery of the June 30, 1995 letter
amendment by ENZON and the consummation by it of the transaction
contemplated herein have been duly authorized by ENZON's Board of
Directors and no further consent or authorization of ENZON's Board of
Directors or stockholders is required. The June 30, 1995 letter amendment
has been duly executed and delivered by ENZ0N, and constitutes a valid and
binding obligation of ENZON enforceable against ENZON in accordance with
it's terms, except as such enforceability may be limited by applicable
bankruptcy, insolvency, or reorganization, moratorium, liquidation, or
similar laws relating to, or effecting generally the enforcement of
creditor's rights and remedies or by other equitable principles of general
application."
"10.11 ENZON represents and warrants that the representations and
warranties provided in Article 10.1 and 10.2 of the Agreement shall also
apply and be binding on ENZON with respect to such Know-How transfer to
SCHERING under Article 3.2(b) above and to SCHERING's or
11
E-127
it's Affiliates as manufacture of Bulk Concentrate or Agreement Product
based on the use of such Know-How."
"10.12 As of June 30, 1995, ENZON represents and warrants that there is no
judicial or administrative action or other proceeding pending or, to the
best of it's knowledge, threatened, nor to the best of it's knowledge is
there any governmental investigation pending or threatened that questions
the validity of any of the transactions contemplated under the June 30,
1995 letter amendment."
"10.13 Enzon represents and warrants that with respect to the manufacture
of "M-PEG", "SC-PEG", and Bulk Concentrate ENZON will provide to SCHERING
all of such Know-How referred to in Article 3.2(a), and the reasonable
technical assistance in manufacturing Bulk Concentrate based on such
Know-How referred to in Article 3.2(b), and that such transfer would
enable a party skilled in the art of manufacture of substances similar to
Bulk Concentrate to be able to reproduce Bulk Concentrate meeting the
specifications of Schedule A-2 as they exist on the effective date of the
June 30, 1995 letter amendment in connection with an eight gram batch
thereof."
Amendment 19
In Article 11.5., the fourth and fifth lines, delete -- (but not for any other
purpose or other product) -- and insert -- (but not in contravention of
SCHERING'S obligations or the prohibitions
12
E-128
covered under Article 3.2) --.
[Amendment 20, 21 and 22 relate to the Supply Agreement between Enzon, Inc. and
Schering Corporation which is no longer in effect, therefore, these Amendments
are not included in this filing]
Amendment 23
13
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In Article VI of the Supply Agreement, delete the last sentence and insert -- in
that case SCHERING shall be free to cancel such purchase order, in addition to
exercising any other legal remedies which SCHERING may have under the Agreement.
Further, in connection with ENZON's breach of it's obligations under this Supply
Agreement, Article 9.3 and Article 14 of the Agreement as they relate to
SCHERING'S right to terminate the Supply Agreement shall be incorporated by
reference into this Supply Agreement --.
Amendment 24
All rights and licenses granted under or pursuant to the Agreement by
ENZON to SCHERING are, for all purposes of Section 365(n) of Title 11 of the
U.S. Code ("Title 11"), licenses of rights to intellectual property as defined
in Title 11. ENZON agreed during the Term to create and maintain current copies
or, if not amenable to copying, detailed descriptions or other appropriate
embodiments, to the extent feasible, of all such intellectual property. If a
case is commenced by or against ENZON under Title 11, then, unless and until
this Agreement is rejected as provided in Title 11, ENZON (in any capacity,
including debtor-in-possession) and its successors and assigns (including,
without limitation, a Title 11 Trustee) shall, as SCHERING may elect in a
written request, immediately upon such request (i) perform all of the
obligations provided in the Agreement to be performed by ENZON including, where
applicable and without limitation, providing to SCHERING portions of such
intellectual property (including embodiments thereof) held by ENZON and such
successors and assigns or otherwise available to them or (ii) provide to
SCHERING all such intellectual property (including all, embodiments thereof)
held by ENZON and such successors and assigns or otherwise
14
E-130
available to them. If a Title 11 case is commenced by or against ENZON, this
Agreement is rejected as provided in Title 11 and SCHERING elects to retain its
rights hereunder as provided in Title 11, then ENZON (in any capacity, including
debtor-in-possession) and its successors and assigns (including, without
limitation, a Title 11 Trustee) shall provide to SCHERING all such intellectual
property (including all embodiments thereof) held by ENZON and such successors
and assigns or otherwise available to them immediately upon SCHERING's written
request therefor. Whenever ENZON or any of its successors or assigns provides
to SCHERING any of the intellectual property licensed hereunder (or any
embodiment thereof) pursuant to this paragraph, SCHERING shall have the right to
perform the obligation of ENZON hereunder with respect to such intellectual
property, but neither such provision nor such performance by SCHERING shall
release ENZON from any such obligation or liability for failing to perform it.
All rights, powers and remedies of SCHERING provided herein are in addition to
and not in substitution for any and all other rights, powers and remedies now or
hereafter existing at law or in equity (including, without limitation, Title 11)
in the event of the commencement of a Title 11 case by or against ENZON.
SCHERING, in addition to the rights, powers and remedies expressly provided
herein, shall be entitled to exercise all other such rights and powers and
resort to all other such remedies as may now or hereafter exist at law or in
equity (including, without limitation, Title 11) in such event. The parties
agree that they intend the foregoing SCHERING's rights to extend to the maximum
extent permitted by law, including without limitation for purposes of Title 11,
(i) the right of access to any intellectual property (including all embodiments
thereof) of ENZON, or any third party with whom ENZON contracts to perform an
15
E-131
obligation of ENZON under the Agreement, and in the case of the third party,
which is necessary for the development, registration and manufacture of Bulk
Concentrate and Agreement Product and (ii) the right to contract directly with
any third party as described in (i) in the sentence to complete the contracted
work.
Except as expressly set forth above, all other non-conflicting terms and
conditions of the Agreement shall remain in full force and effect.
Please indicate your acceptance of the foregoing by signing the enclosed copy of
this letter amendment and returning it to us.
Very truly yours,
ENZON, INC.
By: /s/
---------------------------
Title: President and Chief Executive Officer
ACCEPTED:
SCHERING CORPORAITON ------------
LEGAL REVIEW
By: /s/ Xxxxx Xxxxxxx
--------------------------- [INITIALS]
------------
Title: Vice President
------------------------------------
JAC/cam
00
X-000
XXXXXXXX X-0
TEST SPECIFICATION
---- -------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-133
SCHEDULE A-2
TEST(1) SPECIFICATION
------- -------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-134
SCHEDULE B
Activity Start/Completion Target Responsibility
-------- ----------------------- --------------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-135
SCHEDULE C
PATENT RIGHTS
DATE DATE
TITLE INVENTOR COUNTRY FILED SERIAL NO. PATENT NO. ISSUED
----- -------- ------- ----- ---------- ---------- ------
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-136
SCHEDULE D
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-137
SCHEDULE G
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-138
SCHEDULE H
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-139
Amendment No. 5 June 24, 1999
AMENDMENT AGREEMENT
This "Amendment Agreement" effective as of the last date on the signature
page hereof, by and between Enzon, Inc. ("ENZON") and Schering Corporation
("SCHERING") amends and supplements that certain Development, License and
Supply Agreement between ENZON and SCHERING dated November 14, 1990, as amended
by: the Letter Amendment effective June 30, 1995, and the amendment letters of
March 2, 1993, October 30, 1992 and December 10, 1991 (collectively, the
"Agreement").
WHEREAS, ENZON has developed technology relating to branched chain PEG and
holds patent rights relating thereto, the U-PEG Patent Rights (as defined
below); and
WHEREAS, SCHERING desires to obtain a license under the U-PEG Patent
Rights; and
WHEREAS, the parties further desire to modify certain provisions of the
Agreement relating to the manufacture of Agreement Product, payment of royalties
on sales of Agreement Product, and rights under Patent Rights and to use
Know-How;
NOW THEREFOR, The parties hereby agree to further amend the Agreement as
follows:
Except as expressly defined herein, all capitalized terms shall have the
meanings set forth in the Agreement, as amended.
1. Add the following new provisions to Article 1:
"1.15 "U-PEG Patent Rights" shall mean United States patent number ***
together with its foreign counterparts and any reissues, re-examinations,
extensions, substitutions, confirmations, registrations, revalidations,
additions, continuations, continuations-in-part and divisions of any of
the foregoing. U-PEG Patent Rights shall not be included in Patent Rights
under the Agreement.
1.16 "Roche Patent Rights" shall mean United States patent which may be
infringed by Agreement Product, together with its foreign counterparts and
any reissues, re-examinations, extensions, substitutions, confirmations,
registrations, revalidations, additions, continuations,
continuations-in-part and divisions of any of the foregoing, which are
owned or controlled by X. Xxxxxxxx Xx Xxxxx Ltd. or its Affiliates
(collectively "Roche").
1.17 "Licensed ENZON Patent Rights" shall mean any ENZON Patent Rights
invented by SCHERING, or jointly by SCHERING and ENZON, and owned and/or
assigned to ENZON pursuant to Section 4.3 of the Agreement."
2. Delete Articles 2.9, 3.1 and the Supply Agreement set forth in Schedule E
in their entirety.
3. Delete Article 1.4 and insert in its place the following:
"1.4 "Bulk Concentrate" shall mean Agreement Product in bulk concentrated
form meeting the criteria set forth in Schedule A-2 hereof.
(Specifications for Bulk Concentrate). SCHERING may amend the
specifications in Schedule A-2 if in its reasonable judgment it is
necessary to do so. ENZON shall not be responsible for such specifications
as amended."
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-140
4. Delete Article 2.6 and insert in its place the following:
"2.6 The parties hereto shall keep each other informed of their activities
hereunder and the status of the Development Program by means of a
quarterly written summary report in a form to be agreed upon by such
parties. ENZON shall, at SCHERING's reasonable request, take all
reasonable steps necessary to allow SCHERING to reference ENZON's drug
master file for Agreement Product, which exists as of June 30, 1995, but
have no obligation to hereafter add to or modify it."
5. Delete Article 4.7 and insert in its place the following:
"4.7 Subject to the other terms of this Agreement, ENZON hereby grants to
SCHERING and SCHERING hereby accepts, an exclusive license, exclusive even
as to ENZON, under the ENZON Patent Rights, the ENZON Existing Know-How
and the ENZON Development Know-How, during the term of this Agreement, to
make, have made, use, import, export, offer for sale and sell Bulk
Concentrate and Agreement Product in the Territory. This license shall
include the right to sublicense: (i) SCHERING's Affiliates with respect to
making and having made the Bulk Concentrate and Agreement Product, (ii)
third party vendors with respect to the manufacture of conforming PEG, and
(iii) its Affiliates or third parties with respect to using importing,
exporting, offering for sale and selling Agreement Product."
6. Delete Article 4.8 and insert in its place the following:
"4.8 Subject to the other terms of this Agreement and for the sole purpose
of ENZON's development and manufacture of Agreement Product for SCHERING,
SCHERING hereby grants ENZON the right, under the SCHERING Information,
the SCHERING Patent Rights, the SCHERING Existing Know-How, the SCHERING
Development Know-How, and the RC License (as hereinafter defined) during
the term of this Agreement, to use Agreement Substance in the development
of Bulk Concentrate and Agreement Product for SCHERING."
7. Add the following new provision to Article 4:
"4.11 ENZON hereby grants to SCHERING and SCHERING hereby accepts a
non-exclusive license in the Territory under the U-PEG Patent Rights
during the term of this Agreement to make, have made, use, import, export,
offer for sale and sell pharmaceutical products in which alpha interferon
as an active ingredient is coupled with PEG. The licenses granted to
SCHERING under this Section 4.11 shall include the right to grant
sublicenses to SCHERING's Affiliates and/or to any third party.
4.12 ENZON hereby grants to SCHERING and its Affiliates, and SCHERING and
its Affiliates hereby accept, a non-exclusive license in the Territory
under the Licensed ENZON Patent Rights for all purposes during the term of
this Agreement. The license granted under this Section 4.12 includes,
without limitation, the right to make, have made, use, import, export,
offer for sale and sell pharmaceutical products comprising one or more
active ingredients coupled with PEG, and the limited right to grant
sublicenses to (i) third party contractors in connection with the
discovery, development and commercialization of such products by or on
behalf of SCHERING or its Affiliates, and/or (ii) SCHERING's, or its
Affiliates', third party licensees and/or distributors of such products."
E-141
8. It is the intent of the parties that ENZON shall be primarily responsible for
the prosecution, maintenance and defense of the U-PEG Patent Rights, at ENZON's
expense, and that the provisions of Article 5 of the Agreement which govern the
performance of such activities with regard to ENZON Patent Rights will also
control with respect to the U-PEG Patent Rights.
9. Delete Article 7.1(b) and insert in its place the following:
"(b) In each calendar year during the term of this Agreement, in
connection with SCHERING's sales of Agreement Product which do not
require payment of a royalty under Article 7-1(a) above, if
Competition (as defined in Article 7.1(d) below) exists in any such
country, SCHERING shall pay ENZON a royalty of ***."
10. Delete Article 7.1(c) and insert in its place the following:
"(c) In each calendar year during the term of this Agreement, in
connection with SCHERING's sales of Agreement Product which do not
require payment of a royalty under Article 7.1(a) above, if
Competition does not exist in any such country, SCHERING shall pay
ENZON a royalty of ***."
11. Delete Article 7.1(d) and insert in its place the following:
"(d) For purposes of this Article 7, "Competition" shall mean sales by a
party or parties (other than Roche, or SCHERING and its Affiliates,
or the licensees, distributors or agents of any of the foregoing) in
any country of the Territory, of a competitive product which
contains alpha interferon (as a significant active ingredient)
coupled with PEG to produce a longer-lasting product, with respect
to which product claims are made which are substantially similar to
those of Agreement Product, and the promotion, marketing or sale of
such competitive product does not infringe any of the Patent Rights
or Know-How exclusively licensed to SCHERING hereunder (or for
which, because of weak or ineffective intellectual property law in a
country or countries, there exists no effective patent of know-how
protection) and: (1) the sales of such competitive product made by
any one party equal *** or, (2) the sales of such competitive
product by two or more parties equal, with respect to such party,
*** but, considering the sales of such competitive product made by
all such parties in the aggregate, equal ***."
12. Add new Articles 7.3 and 7.4 as follows:
"7.3 Notwithstanding the terms of Article 7.2, SCHERING will not be
entitled to deduct any amount paid as Third-Party Royalties to X. Xxxxxxxx
Xx Xxxxx Ltd. or its Affiliates ("Roche") as a result of any Roche Patent
Rights which may be infringed by SCHERING's sales of Agreement Product.
SCHERING shall have the right, in its sole discretion, to negotiate the
settlement of any claim or action related to the infringement of
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-142
any Roche Patent Rights. SCHERING will allow ENZON to participate in such
negotiations.
7.4 ***
13. Add the following new provision to the end of Article 8.1:
"SCHERING's obligation to pay royalties on sales of Agreement Product
shall expire, unless terminated earlier as expressly provided in Article
9, on a country-by-country basis upon the longer of(a) the life in each
country of the last to expire of the ENZON Patent Rights for which a Valid
Claim exists, including any patent extension (or other governmental action
which has the effect of extending the period of market exclusivity of the
patent owner) which is permitted by law and obtained, or (b) fifteen (15)
years from the date on which Agreement Product is first approved for
commercial marketing in each such country."
l4. Delete Article 9.1 and insert in its place the following:
"9.1 This Agreement shall be made effective on the date first written
above and shall continue in effect, unless terminated earlier as expressly
provided herein, for a term which shall expire, on a country-by-country
basis, upon the longer of (a) the duration of SCHERING's obligation to pay
royalties in each country, as set forth Article 8.1, or (b) the life in
each country of the last to expire of the U-PEG Patent Rights and/or
Licensed ENZON Patent Rights, including any patent extension (or other
governmental action which has the effect of extending the period of market
exclusivity of the patent owner) which is permitted by law and obtained
("Term")."
15. In Article 10.3, in lines three and four, delete the term -- and the
Supply Agreement --.
16. Delete Article 10.7 and insert in its place the following:
"10.7 During the term of this Agreement Enzon shall maintain an adequate
insurance program for liability insurance, including products liability
and contractual liability insurance, to cover its obligations under this
Agreement."
17. It is the intent of the parties that during and after the term of the
Agreement SCHERING shall have the right to utilize any Development Know-How
developed by SCHERING, either alone or jointly with ENZON, as well as any
Licensed ENZON Patent Rights, SCHERING Independent Know-How and SCHERING
Existing Know-How, to independently develop and commercialize products in which
one or more active ingredients, whether proteins (other than Agreement
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-143
Substance) or other compounds, are coupled with PEG ("Other Products"). The
parties acknowledge and agree (i) that any and all Other Products are outside
the scope of the Agreement, (ii) that nothing contained in the Agreement or this
Amendment Agreement shall be construed, either expressly, by estoppel or
otherwise, as granting or otherwise providing to ENZON any license or other
rights in or to such Other Products, and (iii) that ENZON will not be entitled
to any milestone payments or royalties under the Agreement or this Amendment
Agreement with respect thereto. In order to give effect to the intent of the
parties the Agreement is hereby amended as follows:
(a) Delete Article 2.12 and insert in its place the following:
"2.12 Nothing herein shall be construed to prevent SCHERING from
independently developing its own technology for combining PEG with
polypeptides and other compounds for any use whatsoever."
(b) Delete Article 3.2(a) and insert in its place the following:
"3.2(a) In consideration of the payments made by SCHERING to ENZON
under the June 30, 1995 letter agreement, ENZON has transferred to
SCHERING Know-How, owned and controlled by ENZON as of June 30,
1995, which is necessary to acquire PEG from third party vendors for
conversion to Bulk Concentrate and to manufacture Bulk Concentrate,
and to obtain regulatory approvals to manufacture Bulk Concentrate
and Agreement Product, and to market Agreement Product. Further to
its obligations specified in Article 11, SCHERING will not disclose
such ENZON Know-How to any party other than a SCHERING Affiliate, a
government authority required to approve the registration or sale of
Agreement Product or other products developed by SCHERING, or a
vendor producing PEG for SCHERING provided such vendor has an
obligation of confidentiality to SCHERING in connection therewith.
Further, SCHERING shall only disclose or allow access of such ENZON
Know-How to only those persons described in this Article 3.2(a) who
need such knowledge or access, as strictly interpreted, in
connection with the above stated purposes.
18. Add the following new representations and warranties to Article 10:
"10.14 ENZON represents and warrants (a) that it has the sole, full and
complete right, title and interest in the U-PEG Patent Rights, (b) that it
has the full right, power and authority to grant the licenses and other
rights granted to SCHERING under this Amendment Agreement, and (c) that as
of the effective date of this Amendment Agreement there are no claims,
judgments or settlements against or owed by ENZON relating to the U-PEG
Patent Rights, and to the best of ENZON's knowledge there are no pending
or threatened claims or litigation, relating to the U-PEG Patent Rights
which have not been disclosed by ENZON to SCHERING, except Civil Action
98-5597 commenced by ENZON against Shearwater Polymers, Inc. in the State
of Alabama.
10.15 Each of SCHERING and ENZON represents and warrants that it has the
right to enter into this Amendment Agreement and has no obligation, or
knows of no obstacle, which would prevent it from carrying out its
obligations and responsibilities hereunder.
10.16 ENZON represents and warrants that the representations and
warranties set forth in Article 10.9 remain true and in full force and
effect as of the effective date of this Amendment Agreement.
E-144
10.17 ENZON represents and warrants that as of the effective date of this
Amendment Agreement it has the requisite corporate power and authority to
enter into and perform its obligations hereunder, that the execution and
delivery of this Amendment Agreement by ENZON and the consummation of the
transactions contemplated hereunder have been duly authorized by ENZON's
Board of Directors and no further consent or authorization of ENZON's
Board of Directors or stockholders is required. This Amendment Agreement
has been duly executed and delivered by ENZON and constitutes a valid and
binding obligation of ENZON, enforceable against ENZON in accordance with
its terms, except as such enforceability may be limited by applicable
bankruptcy, insolvency, or reorganization, moratorium, liquidation, or
similar laws relating to, or affecting generally the enforcement of
creditor's rights and remedies or by other equitable principles of general
application.
10.18 ENZON represents and warrants (a) that to the best of ENZON's
knowledge based on diligent inquiry, as of the effective date of this
Amendment Agreement the U-PEG Patent Rights are free and clear of any
liens, charges or encumbrances, and no other person, corporate or private
entity, or governmental entity or subdivision thereof, has or shall have
any claim of ownership with respect to such U-PEG Patent Rights, (b) that
during the Term of the Agreement ENZON will use reasonable diligent
efforts not to diminish the rights under the U-PEG Patent Rights granted
to SCHERING hereunder, including without limitation, by not committing or
permitting any actions or omissions which would cause the breach of any
third party agreements relating to the U-PEG Patent Rights, that it will
provide SCHERING promptly with notice of any such alleged breach, and that
as of the effective date of this Amendment Agreement, ENZON is in
compliance in all material respects with all such third party agreements,
if any."
19. The parties acknowledge and agree that the licenses under the U-PEG Patent
Rights granted to SCHERING under this Amendment Agreement are licenses of
rights to intellectual property and are subject to the provisions set forth in
Amendment 24 of the Letter of Agreement dated June 30, 1995.
Except as expressly amended and supplemented hereby, all other terms of
the Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment
Agreement to be executed in duplicate by their duly authorized representatives.
------------
LEGAL REVIEW
[INITIALS]
------------
ENZON, INC. SCHERING CORPORATION
BY: /s/ Xxxx X. Xxxxxx BY: /s/ Xxxxx Xxxxxxx, Ph.D.
------------------------------ -----------------------------------
NAME: Xxxx X. Xxxxxx NAME: Xxxxx Xxxxxxx, Ph.D.
---------------------------- ---------------------------------
TITLE: VP - Admin & Gen. Counsel TITLE: Vice President
--------------------------- --------------------------------
DATE: 6/24/99 DATE: 23 June 1999
---------------------------- ---------------------------------
E-145
Amendment No. 6 September 13, 1999
AMENDMENT
This "Amendment" effective as of the last date on the signature page
hereof, by and between Enzon, Inc. ("ENZON") and Schering Corporation
("SCHERING") amends and supplements that certain Development, License and Supply
Agreement between ENZON and SCHERING dated November 14, 1990, as amended by:
the Amendment Agreement effective June 24, 1999, the Letter Amendment effective
June 30, l995, and the amendment letters of March 2, 1993, October 30, 1992 and
December 10, 1991 (collectively, the "Agreement").
WHEREAS, the parties desire to clarify the scope of certain provisions of
the Agreement relating to (i) non-competition restrictions imposed on ENZON,
(ii) ENZON's rights under ENZON Patent Rights to which SCHERING may acquire
title under the terms of the Agreement, and (iii) assignment or change of
control;
NOW THEREFOR, The parties hereby agree to further amend the Agreement as
follows:
Except as expressly defined herein, all capitalized terms shall have the
meanings set forth in the Agreement, as amended.
1. Delete Article 2.13 and insert in its place the following:
"2.13 During the term of this Agreement, anything to the contrary
contained herein notwithstanding, ENZON and its Affiliates shall not
develop any product containing PEG and alpha interferon for itself or with
or for any third party, nor shall it or its Affiliates enter into
discussions or negotiations with any third party concerning any product
containing PEG and alpha interferon."
2. Delete Article 5.1.2 and insert in its place the following:
"5.1.2 ENZON shall notify SCHERING immediately (1) whenever it files a
patent application related to the ENZON Patent Rights in any country; and
(2) whenever it is considering discontinuance of the prosecution or
maintenance of such a patent application. If ENZON shall fail to file a
patent application related to the ENZON Patent Rights in any country it
shall notify SCHERING immediately in writing, and (a) if ENZON does not
initiate the filing process within ninety (90) days after written request
to do so from SCHERING, or (b) if ENZON does not continue prosecution or
maintenance of such a patent application related to the ENZON Patent
Rights which it has initiated pursuant to the Article 5.1.1 above within
ninety (90) days after written notice from SCHERING, SCHERING shall have
the option to file or continue prosecution in its own name and at
SCHERING's cost. In either such case (a) or (b), ENZON shall do all acts
necessary to assign and vest title to and transfer control of such patent
application in that country in a timely fashion to SCHERING for no
additional consideration. SCHERING hereby covenants that during the term
of this Agreement SCHERING and its Affiliates shall not file or initiate
any suit or other legal action or proceedings against ENZON with respect
to any products, with the exception of products containing both PEG and
alpha interferon, for infringement of any patents acquired, or obtained by
SCHERING from patent applications filed and/or prosecuted by SCHERING,
under this Section 5 1.2 in the
E-146
Territory, The covenant not to xxx set forth in this Section 5.1.2 is
personal to ENZON and shall not be transferred or assigned to any third
party."
3. Delete Article 13.2 and insert in its place the following:
"13.2 Either party hereto may assign this Agreement, without the other
party's consent, to a third party in a transaction in which all the assets
of the assigning party relating to Agreement Product are sold or assigned;
provided such third party was not selling (directly or through an
Affiliate) a product competitive to the Agreement Product prior to such
assignment.
In the event of any such permitted assignment, transfer or designation,
the assignee, transferee or designee shall assume and be bound by the
provisions of this Agreement."
4. Add new Article 13.3 as follows:
"13.3 In the event that any assignment pursuant to Section 13.1 or 13.2
causes ENZON's rights and obligations hereunder to pass to any third party
which itself or through an Affiliate is developing, manufacturing,
marketing, distributing or selling a product competitive to the Agreement
Product, then SCHERING's obligation under Section 2.6 to keep ENZON
informed and provide quarterly reports with respect to the Development
Program shall immediately terminate."
Except as expressly amended and supplemented hereby, all other terms of
the Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be
executed in duplicate by their duly authorized representatives.
------------
LEGAL REVIEW
[INITIALS]
------------
ENZON, INC. SCHERING CORPORATION
BY: /s/ Xxxx Xxxxxx BY: /s/ Xxxxx Xxxxxxx, Ph.D.
------------------------------ -----------------------------------
NAME: Xxxx Xxxxxx NAME: Xxxxx Xxxxxxx, Ph.D.
---------------------------- ---------------------------------
TITLE: VP - Admin & GC TITLE: Vice President
--------------------------- --------------------------------
DATE: 9/13/99 DATE: 8 September 1999
---------------------------- ---------------------------------
E-147
Amendment No. 7
AMENDMENT
WHEREAS, Schering Corporation ("Schering") and Enzon, Inc. ("Enzon")
are parties to that certain Development, License and Supply Agreement having an
effective date of November 14, 1999, as amended (the "Agreement"),
WHEREAS, Schering's parent company is a party to Xxxxxxx-XxXxxxx
Inc. v. Schering-Plough Corp., Civil Action No. 00-79 (JAG) pending in the U.S.
District Court for the District of New Jersey (the "Roche v. Schering case"),
WHEREAS, Enzon commenced on September 5, 2000 a suit for patent
infringement against Xxxxxxx-Xx Xxxxx Inc. and Roche Laboratories Inc. in
Federal court in New Jersey (the "Enzon x. Xxxxx" case), and
WHEREAS, Schering and Enzon wish to clarify the effect of the
Agreement, including paragraph 2.13 thereof, on (i) the grant of a license or
sublicense under the U-PEG Patent Rights (as defined in the Agreement) to
Xxxxxxx-XxXxxxx Inc., Xxxxx Laboratories Inc., or their parents, subsidiaries,
affiliates, successors, assigns or third parties acting on their behalf
(collectively, "Roche"); and (ii) the settlement of Roche v. Schering.
THEREFORE, the Agreement is hereby amended as follows:
1. Schering shall have sole authority to negotiate and settle (i) Roche
v. Schering; and (ii) the Enzon x. Xxxxx and/or related cases ("the
Cases") (including the right to assume control of the Cases in the
event Enzon decides to discontinue such cases for any reason) or
license Roche under the U-PEG Patent Rights in the field of
pegylated alpha interferon; and Enzon shall not settle the Cases
with or license Roche or directly or
CONFIDENTIAL
E-148
impliedly a third party to enable Roche to make, use, sell, offer to
sell or import pegylated alpha interferon products under the U-PEG
Patent Rights without Schering's written consent (except as provided
below).
2. If a settlement between Schering and Roche results in withdrawal of
PEG-INTRON from the United States market, then Enzon shall have the
right to negotiate and settle the Cases with Roche under terms as
Enzon sees fit, including the grant of a license to Roche under the
U-PEG Patent Rights.
3. Schering shall not sublicense Roche under the U-PEG Patent Rights
except as part of a settlement that (i) licenses or releases
Schering under Roche's U.S. patent(s) covering PEG-INTRON; and (ii)
releases Enzon from any counterclaims or demands asserted against
Enzon by Roche (on behalf of Roche and not on behalf of a third
party) relating to the U-PEG patents or in the field of pegylated
alpha interferon products.
4. If Schering grants a sublicense under the U-PEG Patent Rights to
Roche to settle the Roche v. Schering or Enzon x. Xxxxx or related
cases that results in royalties or royalty equivalents from Roche to
Schering in connection with a license to Roche under the U-PEG
patent rights, such royalties and royalty equivalents that exceed
the value of any royalties or royalty equivalents paid by Schering
to Roche under a license to Schering under the Roche patents
relating to urethane linked pegylated interferon shall be divided
equally between Schering and Enzon. A license under the Roche
patents for Schering to market PEG-INTRON shall not be considered
royalty or royalty equivalents to Schering and is not subject to
division with Enzon hereunder. In the event of a dispute between
Schering and Enzon regarding whether Schering has received royalties
or royalty equivalents from Roche that exceed the value of any
E-149
royalties or royalty equivalents paid by Schering to Roche, such
dispute shall be resolved pursuant to the arbitration provision in
the Agreement.
5. This Amendment contains the entire agreement of the parties
concerning the subject matter set forth herein. Except as expressly
amended by this Amendment, all terms of the Agreement and all
previous amendments shall remain in full force and effect.
IN WITNESS WHEREOF, the parties have caused this Amendment to be
executed in duplicate by their duly authorized representatives.
ENZON, INC. SCHERING CORPORATION
By: By: /s/
------------------------------ -----------------------------------
Authorized Representative Authorized Representative
Date: Date:
---------------------------- ---------------------------------
E-150
Amendment No. 8 August 10, 2001
AMENDMENT
This "Amendment" effective as of the last date on the signature page
hereof, by and between Enzon, Inc. ("ENZON") and Schering Corporation
("SCHERING") amends and supplements that certain Development, License and Supply
Agreement between ENZON and SCHERING dated November 14, 1990, as amended (the
"Agreement").
WHEREAS, the parties desire to clarify the scope of certain provisions of
the Agreement relating to SCHERING's rights under the ENZON Patent Rights and
the Licensed ENZON Patent Rights;
NOW THEREFORE, the parties hereby agree to further amend the Agreement as
follows:
Except as expressly defined herein, all capitalized terms shall have the
meanings set forth in the Agreement, as amended.
1. Amend Article 1.2 of the Agreement by adding the following new provision
to the end of the first sentence of that Article:
", whether or not developed by SCHERING under this Agreement."
2. Add the following new provision to the end of Article 2.13:
"The parties acknowledge and agree that nothing in this Article 2.13 shall
be construed as preventing Enzon from acquiring, through merger,
acquisition or other similar transaction, all or substantially all of the
business and assets of Shearwater Polymers, Inc. ("Shearwater") or from
entering into discussions or negotiations with Shearwater with regard to
such an acquisition."
3. Amend Article 2 of the Agreement by adding the following new provisions:
"2.14 During the term of this Agreement and subject to receipt of the
necessary regulatory approvals, SCHERING shall use commercially
reasonable efforts to market, promote, distribute and sell an Agreement
Product developed by SCHERING or its Affiliates under this Agreement in
the United States, United Kingdom, France, Germany, Italy and Spain and in
any other countries where in SCHERING's opinion it is commercially viable
to do so. Such commercially reasonable efforts shall be consistent with
the usual practice followed by SCHERING in pursuing the commercialization
and marketing of its other pharmaceutical products of similar potential,
value and status. The parties acknowledge and agree that all business
decisions relating to the commercialization of the Agreement Product,
including, without limitation, decisions relating to registration, design,
manufacture, sale, commercialization, pricing, distribution, marketing and
promotion of
E-151
No. 8
Agreement Products, shall be within the sole discretion of SCHERING
exercised in good faith.
2.15 SCHERING's obligations with respect to commercialization of Agreement
Product under Article 2.14 are expressly conditioned upon the continuing
absence of any adverse condition or event which warrants a delay in
commercialization of the Agreement Product, including, but not limited to,
an adverse condition or event relating to the safety or efficacy of the
Agreement Product, or unfavorable labeling, pricing or pricing
reimbursement approvals, or lack of regulatory approval, and such
obligations shall be delayed or suspended so long as in SCHERING's
reasonable opinion any such condition or event exists."
4. Amend Article 4 of the Agreement by adding the following new provision:
"4.13 The rights granted to SCHERING under the ENZON Patent Rights in
Article 4.7 and the Licensed ENZON Patent Rights in Article 4.12 shall, to
the extent not previously granted, additionally include the right to grant
a royalty bearing, non-transferable, non-exclusive sublicense, with no
right to grant sublicenses to others, to Xxxxxxxx-XxXxxxx Inc., X.
Xxxxxxxx-XxXxxxx Ltd. and their respective Affiliates (collectively,
"Roche") in the Territory (as such term is defined in the Settlement and
License Agreement by and between SCHERING and Roche, dated as of August
10, 2001 (the "Settlement Agreement") to Commercialize Licensed Roche
Product under the Enzon Patent Rights (as such terms are defined in the
Settlement Agreement)."
5. Delete Article 7.1(b) in its entirety and insert in its place the
following:
(b) In each calendar year during the term of this Agreement, in
connection with Net Sales of Agreement Product which do not
require payment of a royalty under Article 7.1(a) above, if
Competition (as defined in Article 7.1(d) below) exists in any
such country, SCHERING shall pay ENZON a royalty of ***.
6. Delete Article 7.1(c) in its entirety and insert in its place the
following:
(c) In each calendar year during the term of this Agreement, in
connection with Net Sales of Agreement Product which do not
require payment of a royalty under Article 7.1(a) above, if
Competition does not exist in any such country, SCHERING shall
pay ENZON a royalty of ***.
7. Amend Article 7.1 of the Agreement by adding the following new provision:
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
E-152
(c) The parties understand and agree that, except as expressly set
forth in section 4 of the Amendment to the Agreement dated
September 22, 2000, nothing in this Agreement shall give rise
to any right by ENZON to receive or claim entitlement to any
royalty payments from SCHERING and its Affiliates, nor shall
SCHERING or its Affiliates have any obligation to make any
royalty payments to ENZON or its Affiliates, under this
Agreement in connection with any sublicense or other rights
granted by SCHERING in the Territory to Roche under the
Settlement Agreement and/or the commercialization of Agreement
Products by Roche pursuant to such sublicense under the
Settlement Agreement (including, without limitation, the
manufacture of Agreement Products on behalf of Roche by
Shearwater and its Affiliates), provided that royalties on
Agreement Product sold by SCHERING or its Affiliates will
become payable at such time, if any, as Roche becomes an
Affiliate of SCHERING. It is understood and agreed that the
provisions of the immediately preceding sentence shall apply
on a country-by-country basis only for so long as such
sublicense granted by SCHERING to Roche under the Settlement
Agreement remains in effect."
8. Delete Article 9.2(b) in its entirety.
9. Amend Article 13 of the Agreement by adding the following new provision:
"l3.4 Nothing in this Agreement shall preclude Roche from becoming an
Affiliate of SCHERING if Roche should otherwise come within the definition
of Affiliate set forth in Article 1.1 of the Agreement.
Except as expressly amended and supplemented hereby, all other terms of
the Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be
executed in duplicate by their duly authorized representatives.
ENZON, INC. SCHERING CORPORATION
BY: /s/ Xxxxxx Xxxxxxx BY:
------------------------------ -----------------------------------
NAME: Xxxxxx Xxxxxxx NAME: Xxxxx Xxxxxxx, Ph.D.
---------------------------- ---------------------------------
TITLE: President and CEO TITLE: Vice President
--------------------------- --------------------------------
DATE: August 10, 2001 DATE:
---------------------------- ---------------------------------
E-153
(e) The parties understand and agree that, except as expressly set
forth in section 4 of the Amendment to the Agreement dated
September 22, 2000, nothing in this Agreement shall give rise
to any right by ENZON to receive or claim entitlement to any
royalty payments from SCHERING and its Affiliates, nor shall
SCHERING or its Affiliates have any obligation to make any
royalty payments to ENZON or its Affiliates, under this
Agreement in connection with any sublicense or other rights
granted by SCHERING in the Territory to Roche under the
Settlement Agreement and/or the commercialization of Agreement
Products by Roche pursuant to such sublicense under the
Settlement Agreement (including, without limitation, the
manufacture of Agreement Products on behalf of Roche by
Shearwater and its Affiliates), provided that royalties on
Agreement Product sold by SCHERING or its Affiliates will
become payable at such time, if any, as Roche becomes an
Affiliate of SCHERING. It is understood and agreed that the
provisions of the immediately preceding sentence shall apply
on a country-by-country basis only for so long as such
sublicense granted by SCHERING to Roche under the Settlement
Agreement remains in effect."
8. Delete Article 9.2(b) in its entirety.
9. Amend Article 13 of the Agreement by adding the following new provision:
"13.4 Nothing in this Agreement shall preclude Roche from becoming an
Affiliate of SCHERING if Roche should otherwise come within the definition
of Affiliate set forth in Article 1.1 of the Agreement.
Except as expressly amended arid supplemented hereby, all other terms of
the Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be
executed in duplicate by their duly authorized representatives.
------------
LEGAL REVIEW
[INITIALS]
------------
ENZON, INC. SCHERING CORPORATION
BY: BY: /s/ Xxxxx Xxxxxxx, Ph.D.
------------------------------ -----------------------------------
NAME: NAME: Xxxxx Xxxxxxx, Ph.D.
---------------------------- ---------------------------------
TITLE: TITLE: Vice President
--------------------------- --------------------------------
DATE: DATE: 10 August 2001
---------------------------- ---------------------------------
E-154
