EXHIBIT 10.15
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AMENDED AND RESTATED
LICENSE AGREEMENT
between
U.S. BIOSCIENCE, INC.
and
SCHERICO, LTD.
DATED MAY 10, 1994
(AS AMENDED AND RESTATED AS OF NOVEMBER 6, 1997)
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TABLE OF CONTENTS
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PAGE
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Recitals.................................................. 1
ARTICLE 1 Definitions............................................... 2
ARTICLE 2 Rights Granted............................................ 7
ARTICLE 3 Obligations of the Parties................................ 14
ARTICLE 4 Up-Front Payment/Royalty/Consulting Fee................... 20
ARTICLE 5 Promotion and Marketing................................... 23
ARTICLE 6 Confidentiality........................................... 24
ARTICLE 7 Additional Documents...................................... 26
ARTICLE 8 Indemnity/Insurance....................................... 26
ARTICLE 9 Breach/Remedies........................................... 28
ARTICLE 10 Recalls/Adverse Reactions................................. 29
ARTICLE 11 Licensor's Representations................................ 33
ARTICLE 12 Term/Termination.......................................... 33
ARTICLE 13 Post-Termination Obligations.............................. 36
ARTICLE 14 Independence of Parties................................... 38
ARTICLE 15 Non-Waiver................................................ 39
ARTICLE 16 Assignment................................................ 38
ARTICLE 17 Severability.............................................. 40
ARTICLE 18 Governing Law-Arbitration................................. 40
ARTICLE 19 Notices................................................... 41
ARTICLE 20 Amendment................................................. 42
ARTICLE 21 Government Approvals...................................... 42
ARTICLE 22 Consents and Approvals.................................... 43
ARTICLE 23 Press Releases/Announcements.............................. 43
INDEX OF ANNEXES
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ANNEX I Patent Rights
ANNEX II Territory
INDEX OF EXHIBITS
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Exhibit 1.13 Product Specification
Exhibit 2.3 Fully Absorbed Cost
AMENDED AND RESTATED
LICENSE AGREEMENT
-----------------
Agreement made the 10th day of May, 1994 (the "Effective Date") between
U.S. BIOSCIENCE, INC., a company organized and existing under the laws of the
State of Delaware, with offices at One Tower Bridge, 000 Xxxxx Xxxxxx, 0xx
Xxxxx, Xxxx Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 (hereafter "LICENSOR"), and
SCHERICO, LTD., a company organized and existing under the laws of Switzerland,
with offices at 0000 Xxxxxxxxx Xxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 acting on
its own behalf and on behalf of its Affiliates (as hereafter defined)
(collectively "LICENSEE"), as amended and restated as of November 6, 1997.
WITNESSETH
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WHEREAS, LICENSOR has rights relating to a pharmaceutical product known as
Ethyol(R) (amifostine) which is being developed by Licensor for use in reducing
toxicities of chemotherapeutic cancer treatments and as a radioprotective agent;
and
WHEREAS, LICENSOR has rights relating to a pharmaceutical product known as
NeuTrexin(R) (trimetrexate glucuronate for injection) which is being developed
by Licensor for use in treating Pneumocystis carinii pneumonia ("PCP") and as an
anti-cancer agent; and
WHEREAS, LICENSOR and LICENSEE on February 14, 1992 entered into a License
Agreement (the "South American Agreement") that grants LICENSEE the right to
market Ethyol in certain countries
in South America and Asia and certain rights relating to Option Products (as
defined in the South American Agreement); and
WHEREAS, LICENSOR wishes to have LICENSEE develop and market Ethyol and
NeuTrexin in certain additional territories, upon the terms and conditions
specified herein.
NOW, THEREFORE, in consideration of the mutual covenants and undertakings
hereafter set forth, the parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
-----------
As used in this Agreement, the following terms shall have the following
meanings:
1.1 "Affiliate/s" of the relevant party hereto means any corporation or
other business entity (currently existing or later established during the term
of this Agreement) controlling, controlled by or under common control with such
party. For purposes hereof, the term "control" (including the terms
"controlling", "controlled by" and "under common control with") means the
possession, direct or indirect, of the power to direct or cause the direction of
the management policies of a person or entity (whether incorporated, not
incorporated or a partnership) through the ownership of voting securities or
voting rights by contract or otherwise.
1.2 "Cost-of-Goods" means the cost to LICENSEE or its designees of a
Product supplied by LICENSOR pursuant to Article 2.3 hereof.
2
1.3 "Force Majeure" means acts or actions beyond the reasonable control of
the parties, including but not limited to strikes or other labor disputes,
riots, lockouts, civil commotions, war, actions or inactions of government,
fire, acts of God, flood, embargo, or any other cause or unforeseeable
supervening event of whatsoever nature (including shortages of labor and
materials).
1.4 "Fully Absorbed Cost" has the meaning set forth on EXHIBIT 2.3 hereto.
1.5 "Gross Margin" means the amount remaining after deducting from Net
Sales the Cost-of-Goods and the royalty and consulting fee payable to LICENSOR
under Article 4.1.C hereof.
1.6 "Health Registration Dossier" means a regulatory dossier prepared for
a Product (in the case of the Product Ethyol, claiming protection against
hematological toxicities associated with the use of alkylating agent(s),
including cyclophosphamide) for filing with the Committee for Proprietary
Medicinal Products, the United States Food and Drug Administration, the Canadian
Health Protection Board, or any other country mutually acceptable to LICENSOR
and LICENSEE.
1.7 "Improvement/s" shall mean with respect to a Product, any improvement
in (i) existing pharmaceutical and any new pharmaceutical formulations and
presentations; (ii) mode of delivery or new delivery system(s); (iii) additional
indications; (iv) new dosage; (v) changes in manufacturing procedure/production
monograph; or (vi) shelf-life extension.
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Over-the-counter versions of a Product and related improvements as defined in
items (i) through (vi) shall also be deemed to be "Improvements" for purposes of
this Agreement.
1.8 "Know-How" with respect to a Product and/or Improvements shall include
but shall not be limited to all confidential and proprietary processes,
specifications, formulae, techniques, practices and technical data relating to
formulation and packaging; existing analytical and clinical data, studies and
procedures; existing directions and specifications for the proper
transformation, compressing, packaging, storing, handling and transporting and
the methods and procedures of testing production batches.
1.9 "Minimum Chemoprotective Labelling" means the following labelling of
the Product Ethyol: protection against hematological toxicities associated with
the use of cyclophosphamide without protection against the associated tumor and
without any restriction limiting use of the Product Ethyol to ovarian cancer.
1.10 "Net Sales" means the gross invoiced value charged by LICENSEE or its
designees (e.g., Affiliates, sub-licensees, distributors) for Products in the
Territory to independent third parties less sales and similar taxes; returns;
allowances; duties; freight and shipping insurance charges; ordinary trade,
quantity and cash discounts; and government mandated rebates. Any sale of a
Product between or among LICENSEE and its Affiliates, sub-licensees or
distributors for resale, shall be
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excluded from the computation of Net Sales, but Net Sales shall include any
subsequent sale to an independent third party by LICENSEE, or by any of
LICENSEE's Affiliates, sublicensees or distributors. Net Sales shall include
commercial use by LICENSEE or its designees (i.e., Affiliate, sub-licensees,
distributors) and shall be calculated at the fair value of the commercial use by
LICENSEE or such designee. For purposes of determining whether LICENSEE has the
right to manufacture a Product pursuant to Section 2.1 hereof, duties; freight;
and shipping insurance shall not be deducted in calculating Net Sales.
1.11 "Patent Rights" means rights under the patents and patent applications
listed in ANNEX I hereto and to any foreign counterparts thereof in the
Territory in which LICENSOR or any of its Affiliates has any right, title,
interest, or control, or hereafter obtains such, to the extent of LICENSOR's
interest therein (and to the extent acquired from third parties, which LICENSOR
shall have the right to license for purposes of this Agreement), including,
without limitation, any and all reissues, extensions (or other governmental
actions in respect of such patents or patent applications 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. Patent
Rights shall include all Patent Rights to Improvements in the Territory
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and any and all patent applications, issued patents, foreign counterparts, and
the like (including, without limitation, any and all reissues, extensions (or
other governmental actions in respect of such patents or patent applications
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 and which claim Improvements to a Product.
From time to time hereunder, LICENSOR shall update ANNEX I.
1.12 "Product" means any product containing as its sole active ingredient
Ethyol(R) (amifostine) or NeuTrexin(R) (trimetrexate glucuronate for injection)
and any Improvements thereto, as further described in the Product
Specifications. The term "Product" also shall include any pharmaceutical
product containing Ethyol(R) (amifostine) or NeuTrexin(R) (trimetrexate
glucuronate for injection) in combination with another active ingredient,
including combination packages containing separate active ingredients, in each
case, subject to the agreement of the parties in writing as to the method for
allocating to Net Sales the Product portion of the combination and any other
terms and conditions applicable to such combination product under this
Agreement. The terms "Product Ethyol" and "Product NeuTrexin" are used in this
Agreement to identify a Product with specificity.
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1.13 "Product Specifications" means the general specifications for a
Product set forth as EXHIBIT 1.13 hereto, as such may be modified to reflect an
Improvement. The Product Specifications also shall be reasonably supplemented
and/or modified from time to time to the extent required by any regulatory
authority in the Territory with respect to obtaining or maintaining a Regulatory
Approval, and may otherwise be modified only by the written agreement of
LICENSEE and LICENSOR. The Product Specifications and any supplements or
modifications thereto shall be documented in such reasonable level of detail as
is customary in the pharmaceutical industry.
1.14 "Territory" means the countries listed on ANNEX II attached hereto and
made a part hereof, as such may be expanded in accordance with Article 2.9
hereof or reduced pursuant to Article 12.4 hereof.
1.15 "Trademark" means the trademark Ethyol(R) or the trademark
NeuTrexin(R) and "Trademarks" means the trademarks Ethyol(R) and NeuTrexin(R),
or, if for any reason either such name is not available or otherwise appropriate
in a particular country, any substitute or additional trademarks selected by
LICENSEE, after consultation with LICENSOR, to promote, market and sell a
Product in a country in the Territory.
ARTICLE 2
RIGHTS GRANTED
--------------
2.1 LICENSOR hereby grants to LICENSEE the exclusive right to utilize
such rights as are held by LICENSOR to develop, use,
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promote, market and sell (directly or indirectly) each Product in the Territory
pursuant to the Know-How, Patents and Improvements. LICENSEE shall have the
right to manufacture a Product in bulk or finished form if LICENSEE's Gross
Margin on such Product is less than 71% during any consecutive twelve (12) month
period; in such event, LICENSEE shall have the right, but not the obligation,
for the balance of the term of this Agreement, to manufacture (or have
manufactured) such Product in accordance with this Agreement, directly or
indirectly through LICENSEE's Affiliates anywhere in the world for sale in the
Territory, or through third parties to be previously approved by LICENSOR in
writing, which approval shall not be unreasonably withheld. Insofar as permitted
as of the Effective Date under any existing license agreements held by LICENSOR
or its Affiliates, LICENSEE shall have the right to sub-license its rights under
this Agreement to any third party/ies in the Territory, subject to LICENSOR's
written approval, which approval shall not be unreasonably withheld. During the
period that LICENSOR is manufacturing a Product for LICENSEE hereunder, if
LICENSEE's Gross Margin on such Product is less than 71% during any consecutive
three (3) month period, LICENSEE shall so advise LICENSOR and shall provide to
LICENSOR reasonable documentation supporting its position that its Gross Margin
on such Product is less than 71%.
2.2 LICENSOR agrees and shall cause its Affiliates to agree not to grant
any rights to a Product in the Territory to any third party other than LICENSEE,
except that LICENSOR may
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manufacture or cause a third party to manufacture either or both Products inside
the Territory.
2.3 Except as provided in Article 2.1 and until such time, if ever, that
LICENSEE manufactures a Product as provided in Article 2.1, LICENSOR shall
supply (either directly or through a third party manufacturer) LICENSEE's
requirements of such Product in accordance with a Supply Agreement to be entered
into by the parties on reasonable terms, which are normal and customary in the
pharmaceutical industry. Under any such supply agreement LICENSOR shall warrant
that the Product that is the subject of such agreement when sold by LICENSOR to
LICENSEE for the Territory will meet the Product Specifications for such
Product. The price of a Product to LICENSEE shall be LICENSOR's or its
Affiliates' Fully Absorbed Cost plus twelve percent (12%) or "invoiced cost".
The term "invoiced cost" shall mean that price at which LICENSOR or its
Affiliate(s) purchase a Product in finished form from independent third parties;
provided however that "invoiced cost" shall not exceed LICENSOR's then current
Fully Absorbed Cost. In the event that the price at which LICENSOR purchases a
Product in finished form from an independent third party is more than LICENSOR's
then current Fully Absorbed Cost, LICENSOR shall have the right to discontinue
supply of such Product for LICENSEE, subject to LICENSOR's obligation to
continue supply of such Product for LICENSEE for a reasonable period of time to
allow LICENSEE to qualify a manufacturing facility to manufacture such Product.
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If LICENSOR's ability to supply LICENSEE's requirements of a Product should
be impaired for any reason, including Force Majeure, LICENSOR shall promptly
provide written notice to LICENSEE of this fact and the parties shall meet in
good faith to discuss an appropriate solution.
2.4 As soon as it is reasonably feasible, but no later than the date of
health registration filing under a New Drug Application or its foreign
equivalent, of a Product utilizing any Improvements in the United States, Japan,
or in any country which is now or later becomes a member of the European
Community, LICENSOR agrees to disclose to LICENSEE, to the extent it shall have
the right to do so during the term of this Agreement or any extensions thereof,
all Improvements to such Product for the Territory. Such Improvements will be
made available on an exclusive and royalty-free basis, and at no charge
whatsoever to LICENSEE other than the royalty and consulting fee set forth in
Article 4.1 C. payable on account of the sale of the Product incorporating such
Improvement(s).
2.5 Subject to the provisions of Section 3.13 of this Agreement, as
soon as it is reasonably feasible, but no later than the date of health
registration filing of a Product by LICENSEE in the Territory utilizing any
Improvements (other than Improvements provided by LICENSOR), LICENSEE agrees to
disclose to LICENSOR, to the extent it shall have the right to do so during the
term of this Agreement or any extensions thereof, all Improvements to such
Product.
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2.6 LICENSOR agrees that it, through its Chief Executive Officer and/or
other executives and/or other qualified professionals of LICENSOR reasonably
acceptable to LICENSEE, shall act as consultant to LICENSEE (such persons being
collectively referred to as "Consultants"). As requested by LICENSEE,
Consultants will provide support to LICENSEE and its Affiliates as is reasonable
and appropriate, which support may include but shall not be limited to (i)
assisting in the development of clinical development plans, (ii) meeting with
investigators and other thought leaders and (iii) meeting with regulatory
officials in the Territory. All salaries of Consultants shall be paid by
LICENSOR and any and all reasonable travel and out-of-pocket expenses incurred
by Consultants shall be shared equally by LICENSOR and LICENSEE.
2.7 LICENSEE shall promote, market and sell each Product in the
Territory under the corresponding Trademark(s). Unless prohibited by local law,
all finished dosage form containers and labelling material for a Product shall
provide that such Product is manufactured by and is being sold under license
from "U.S. Bioscience, Inc." If a Product is not being manufactured by
LICENSOR, all finished dosage form containers and labelling material for such
Product shall provide that such Product is under license from "U.S. Bioscience,
Inc." LICENSEE shall appropriately identify, in compliance with local laws,
each Product being commercialized in the Territory with any Patent numbers or
appropriate patent legend applicable to such Product.
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LICENSOR shall apply for and diligently prosecute a trademark registration for
the Trademarks in South Africa, Australia and New Zealand. LICENSOR shall renew
and maintain the Trademark(s) filed in its name at its cost and expense, and
shall defend such Trademark(s) in accordance with Section 3.11 hereof. In the
event that LICENSEE makes a determination that a trademark registration should
be filed for a Trademark in any other country in the Territory, LICENSEE shall
so advise LICENSOR in writing. Within fifteen (15) business days of such
notification, LICENSOR shall advise LICENSEE in writing as to whether LICENSOR
will make such filing in its own name and at its own expense. In the event
LICENSOR determines that LICENSOR will not make such filing, LICENSEE agrees to
file or cause to be filed an application in such country in the Territory for
the Trademark and to diligently prosecute such application. Any such filings
shall be in LICENSEE's name and at LICENSEE's cost and expense. LICENSEE shall
renew and maintain the Trademark(s) filed in its name at its own cost and
expense, and shall defend such Trademark(s) in accordance with Section 3.11
hereof. LICENSOR hereby grants to LICENSEE the right to become a Registered User
or recorded licensee of the Trademarks, if required by the laws of the
Territory. In those countries in the Territory wherein LICENSOR is the
registered Trademark owner, LICENSOR hereby grants LICENSEE an exclusive,
royalty-free license to use the Trademarks in any country in the Territory in
connection with the exercise of the rights granted herein. Any Trademarks filed
in LICENSEE's
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name hereunder shall be transferred to LICENSOR upon expiration or termination
of this Agreement, in accordance with Article 13.2 hereof. Other than the rights
expressly granted under this Agreement, LICENSEE shall have no other rights to
use the Trademarks.
2.8 If LICENSOR in its sole discretion decides to use a third party (third
party does not include an Affiliate of LICENSOR) to develop or commercialize any
other of its pharmaceutical products in the Territory, whether under license,
distribution agreement or otherwise, LICENSOR shall notify LICENSEE in writing
of its decision. If LICENSEE wishes to make an offer for the right to
commercialize such other product, it shall notify LICENSOR of LICENSEE's
interest, in writing, within ten (10) business days after receiving LICENSOR's
notice. If LICENSEE so elects, LICENSEE and LICENSOR shall negotiate in good
faith to reach mutually agreeable terms with respect to such product. If an
agreement is not reached within eighty (80) days after LICENSEE's election to
make an offer, LICENSOR shall be free to negotiate and enter into a transaction
with other third parties.
2.9 LICENSEE shall have the right to expand the Territory to include the
country of Egypt upon the lapse of preexisting rights to commercialize the
Products that have been granted by LICENSOR to RAMCO PHARM. LICENSOR shall
notify LICENSEE if the right to commercialize Ethyol in Egypt becomes available,
and LICENSEE shall thereafter have thirty (30) days in which to elect
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to include Egypt within the Territory under the terms of this Agreement. In
addition, LICENSEE shall have the right to expand the Territory to include the
country of Lebanon, which right shall be exercisable by notice to such effect
delivered by LICENSEE to LICENSOR not later than December 31, 1997.
ARTICLE 3
OBLIGATIONS OF THE PARTIES
--------------------------
3.1 LICENSEE agrees that if it undertakes to manufacture a Product under
Article 2.1 hereof, it shall do so in compliance with Good Manufacturing
Practices and pursuant to specifications contained in the Know-How as long as
such specifications are acceptable to local authorities in the Territory. In
discharging its obligations hereunder, LICENSEE agrees to observe all applicable
laws and regulations, and shall obtain all necessary licenses, permits and
authorizations to market each Product in the Territory.
3.2 LICENSEE shall use the Know-How and Patents only in connection with
the development, manufacture, use, packaging, promotion, marketing and sale of
the Products in the Territory and only to the extent permitted under this
Agreement.
3.3 LICENSEE agrees to use its diligent efforts to file or cause to be
filed in each country in the Territory, in its own name or in the name of any of
its Affiliates, an application for the health registration of each Product and
any applications for pricing and reimbursement approvals required to market each
Product, and to use its commercially reasonable diligent efforts
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to achieve the broadest indication for each Product approval based on the Health
Registration Dossier for such Product supplied by LICENSOR hereunder,
substantially consistent with the final recommendation of the European Union's
Committee for Proprietary Medicinal Products and/or the United States Food and
Drug Administration, all at LICENSEE's cost and expense. LICENSEE shall
diligently seek to obtain all such approvals and authorizations.
3.4 For the purposes set forth under Article 3.3 and subject to the
provisions of Article 6 hereof, LICENSOR agrees to make available or cause to
make available to LICENSEE all LICENSOR health registration data (including,
without limitation certificates of free sale or their equivalent) and all
applicable scientific data available to LICENSOR in any country in the world;
provided however that data which is the property of a third party will only be
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provided to LICENSEE if LICENSOR has the right to do so or to the extent that
such third party has consented to providing such data to LICENSEE, and/or to
grant rights of reference to all of such data so as to enable LICENSEE (or its
Affiliates) to secure regulatory approval and manufacture, use, promote, market
and sell the Products in the Territory and only to the extent permitted under
this Agreement. To the extent that it is contractually permitted, LICENSOR shall
also share or cause to be shared with LICENSEE all data available in any country
in the world to LICENSOR or its Affiliates from any third party which data the
parties mutually agree shall be
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useful to secure health registration approval for a Product in the Territory.
3.5 LICENSOR and LICENSEE agree to consult each other to enable LICENSEE
to file an application for the health registration of each Product containing a
dossier meeting all regulatory requirements in each country of the Territory.
3.6 LICENSEE shall conduct or cause to be conducted such local clinical
trials as LICENSEE reasonably deems necessary and shall bear the costs for same,
including all costs associated with any pricing/marketing approvals. All data
generated by LICENSEE related to a Product shall be made available to LICENSOR
free of charge for use outside the Territory only in connection with the
Product. Subject to the provisions of Article 6 hereof, LICENSOR shall have the
right to disclose said data to LICENSOR's sub-licensees and/or consultants for
use outside the Territory as long as LICENSOR secures from such sub-licensees
and/or consultants in writing the obligation to disclose to LICENSEE all data
related to such Product generated by them for LICENSEE's use in the Territory.
3.7 Should LICENSEE decide, consistent with the provisions of Article
3.3, not to file or cause to be filed an application for health registration or
not to market after receipt of health registration approval of a Product in any
country or countries in the Territory, LICENSEE shall promptly communicate so in
writing to LICENSOR, and LICENSEE shall thereafter have no further obligation to
commercialize such Product in such country or
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countries. LICENSOR shall then have the right to license such Product in the
country(ies) in question to a third party licensee. Such right shall be in
addition to any rights LICENSOR may have under Article 12.4 hereof.
3.8 LICENSEE agrees to submit to LICENSOR:
(1) An accounting of all sales of each Product by units and sales
(in U.S. Dollars), on a calendar quarter basis, within sixty (60) days
after the close of each calendar quarter. Such accounting shall show gross
sales and Net Sales on a country-by-country and Product-by-Product basis;
(2) From time to time, and to the extent LICENSEE is able, any other
reports which LICENSOR may reasonably require.
3.9 LICENSEE shall use each of the Trademark(s) solely in the packaging,
promotion, marketing and sale of the respective Product in the Territory.
3.10 If LICENSEE undertakes the manufacture of a Product pursuant to
Article 2.1 hereof, LICENSEE agrees that upon prior written notice of at least
five (5) business days, LICENSOR or its designee shall have the right, at all
reasonable times, to inspect the Product manufactured by or for LICENSEE at the
manufacturing sites as well as the methods of manufacturing and packaging.
LICENSOR shall also have the right, upon giving the above referred written
notice, to perform audits from time to
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time at all reasonable times in order to verify LICENSEE's compliance with Good
Manufacturing Practices.
3.11 LICENSEE agrees not to acquire and not to claim any right, title or
interest in the Know-How and/or Patent Rights as a result of or pursuant to this
Agreement, except for those Improvements developed by LICENSEE. The parties
agree to immediately notify each other in writing of any infringement of the
Patent Rights or the Trademarks or claims that the Patent Rights or the
Trademarks may infringe, which may come to their attention, and agree to join
each other, if requested by the owner of the Patent Rights or the Trademarks in
question and at the owner's expense, in taking action against the infringement
or otherwise for the protection or the defense of such Patent Rights or
Trademark(s). In the event LICENSOR does not wish to take the necessary action
to defend or to protect the Patent Rights or the Trademarks or to prosecute any
infringement of the Patent Rights or the Trademark(s), LICENSEE shall have the
right, but not the obligation, to do so at LICENSEE's expense, and in such case,
any proceeds resulting from such action shall be the exclusive property of
LICENSEE. Under this Agreement, the LICENSOR shall have no obligation to
maintain the Patent Rights in the Territory. In the event that LICENSOR elects
not to maintain any of the Patent Rights, LICENSOR shall so advise LICENSEE in a
timely manner to enable LICENSEE to take appropriate action, at its expense, to
maintain the particular patent involved or to continue prosecution of the
particular patent application. The
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LICENSOR shall remain the owner of all of the Patent Rights even if LICENSEE
elects to maintain any Patent Rights under this provision.
3.12 If LICENSEE undertakes the manufacture of a Product pursuant to
Article 2.1 hereof, LICENSEE agrees to conduct such quality control tests and to
implement such quality control procedures as the parties shall mutually agree.
In such event, LICENSOR agrees to provide to LICENSEE, its Affiliates and/or
designees, at LICENSOR's cost and expense, all reasonable technical assistance
which LICENSEE may require in connection with the application of the Know-How to
the manufacture of such Product.
3.13 To the extent LICENSEE shall have the right to do so, any
Improvements developed by LICENSEE or its designees (e.g., Affiliates, sub-
licensees or distributors) during the life of this Agreement shall be licensed
to LICENSOR on a perpetual, exclusive and royalty-free basis: (i) for use in
connection with the Products outside the Territory; (ii) for use in connection
with the Products in the Territory upon termination or expiration of this
Agreement; and (iii) for use in connection with the Products in any country in
the Territory upon termination of this Agreement with respect to such country.
LICENSOR shall have the right to grant royalty-free sublicenses of the foregoing
licenses in the event LICENSOR has obtained from its sub-licensees in writing an
exclusive and royalty-free grant-back license of sub-licensees' Improvements for
use in the Territory exclusively by
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LICENSEE or its designees or with the written consent of LICENSEE which consent
shall not be unreasonably withheld.
3.14 LICENSEE shall not actively promote or advertise either of the
Products outside the Territory and shall not establish a branch or distribution
depot for the sale of either of the Products outside the Territory, except as
otherwise authorized in writing by LICENSOR.
LICENSEE shall use its diligent efforts subject to all laws and regulations
applicable to LICENSEE to cause its sub-licensees and/or distributors to
undertake to comply with LICENSEE's obligations under this Article 3.14 and
shall take the necessary action to enforce said undertakings, and if necessary
upon mutual written agreement of LICENSOR and LICENSEE, to discontinue supply of
any Product to the sub-licensees and/or distributors who have breached this
undertaking.
ARTICLE 4
UP-FRONT PAYMENT/ROYALTY/CONSULTING FEE
---------------------------------------
4.1 In consideration of the rights granted under this Agreement,
LICENSEE shall pay or cause to be paid to LICENSOR:
A. on the date of execution of this Agreement, the amount of
United States Dollars One Hundred Thousand (U.S. $100,000.00) (the "Up-
front Payment"). The Up-front Payment shall be fully credited against the
royalties to be paid by LICENSEE under Article 4.1 C. (i) below and as set
forth under Article 4.1 D. below.
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B. upon the occurrence of the events set forth below, the
corresponding milestone payment (the "Milestone Payments") which shall not
be credited against the royalties to be paid by LICENSEE under Article 4.1
C. below:
Milestone Payment (in
--------- United
States Dollars)
------------------
Receipt by LICENSEE of marketing $200,000
approval (excluding any pricing and
reimbursement approvals) of the
Product Ethyol in Australia with
Minimum Chemoprotective Labelling
Receipt by LICENSEE of marketing $100,000
approval (excluding any pricing and
reimbursement approvals) of the
Product Ethyol in South Africa with
Minimum Chemoprotective Labelling
provided however, that if Product Ethyol approval is achieved without Minimum
----------------
Chemoprotective Labelling in Australia, in order to retain its rights hereunder
with respect to Australia, LICENSEE shall be required to pay to LICENSOR a
milestone payment of United States Dollars One Hundred Thousand ($100,000); and
if the Product Ethyol approval is achieved without Minimum Chemoprotective
Labelling in South Africa, in order to retain its rights hereunder with respect
to South Africa, LICENSEE shall be required to pay to LICENSOR a milestone
payment of United States Dollars Fifty Thousand ($50,000). If LICENSEE elects
not to make a Milestone payment which has become due, LICENSEE's rights with
respect to the country to which the Milestone payment relates shall terminate.
C. subject to the provisions of Article 4.1 D., the following
royalty and consulting fee during each calendar year during the term of
this Agreement:
(i) a royalty of 6% of the Net Sales; and
(ii) a fee for the consulting services rendered pursuant to
Article 2.6 hereof, equal to 6% of the Net Sales.
21
D. It is agreed the Up-front Payment shall be credited against
payments due from LICENSEE pursuant to Section 4.1 C.(i) until the credit
due for the Up-front Payment has been fully exhausted, at which time
LICENSEE shall pay to LICENSOR such royalty in accordance with the terms of
this Agreement.
4.2 Except as otherwise provided in this Article 4, all payments due to
LICENSOR pursuant to Article 4.1 C. above, shall be in United States Dollars (or
in local currency as notified in writing from time to time by LICENSOR) paid
within sixty (60) days of the end of each calendar quarter. Such payments shall
be by wire transfer in immediately available funds to such bank and account as
LICENSOR shall notify LICENSEE, in writing, from time to time hereunder.
LICENSEE shall use diligent efforts in taking any and all action which may be
required under the laws, rules, regulations and the like in the Territory,
including but not limited to timely application to the appropriate authorities,
to ensure that payment shall be made within the time stipulated herein.
LICENSEE shall bear all expenses in connection with obtaining such
authorizations.
4.3 The royalty and consulting fee in Article 4.1 C. shall be calculated
on a quarterly basis. Where applicable, the exchange rate shall be the spot
rate of exchange for the sale of United States Dollars at close of business
prevailing at Citibank, New York on the last business day of each quarter.
22
4.4 LICENSEE agrees to maintain at its principal offices or at those of
its Affiliates accurate and complete books and records of its gross sales and
Net Sales of each Product, and related expenses, consistent with sound business
and accounting practices and in such form and in such detail as to enable the
amount payable hereunder by LICENSEE to LICENSOR to be determined. LICENSEE
shall permit LICENSOR or its designee or any independent certified accountant
appointed by LICENSOR and reasonably acceptable to LICENSEE, at LICENSOR's
expense, to examine such books and records at all reasonable times for the
purpose of (i) verifying LICENSEE's reports and accounting submitted to LICENSOR
hereunder and (ii) determining the correctness of the payments made by LICENSEE
hereunder; provided however, that such examinations shall take place not more
-----------------
often than once per calendar year.
ARTICLE 5
PROMOTION AND MARKETING
-----------------------
5.1 LICENSEE shall use its diligent efforts to promote, market and sell
(or to cause to be promoted, marketed and sold) each Product throughout the
Territory at its own expense. Such efforts will be commensurate with those
efforts LICENSEE utilizes on behalf of its own products of similar commercial
potential.
5.2 As may reasonably be required by LICENSEE, LICENSOR shall supply
LICENSEE or its designee free of charge, if LICENSOR's contractual rights allow
for it, LICENSOR's or LICENSOR's sub-licensees' released specimens of such
samples,
23
displays, sales promotion material and literature available to LICENSOR or
LICENSOR's sub-licensees outside the Territory.
5.3 LICENSOR agrees to provide LICENSEE, at LICENSOR's Fully Absorbed
Cost, such reasonable quantities of each Product as may be required for clinical
trials in the Territory.
5.4 Prior to LICENSEE's launching of each Product, the parties shall
agree on the uses for which LICENSEE shall promote (or cause to promote) such
Product. Any other additional uses or deletions/changes to the agreed upon uses,
shall be mutually agreed by the parties in writing.
5.5 In their activities contemplated by this Agreement, LICENSEE and its
Affiliates shall comply with all applicable laws and regulations, including
without limitation, laws and regulations of the countries in the Territory.
LICENSEE shall cause its designees (e.g. Affiliates, sub-licensees and
distributors) to comply with all applicable laws and regulations, including
without limitation, laws and regulations of the countries in the Territory.
ARTICLE 6
CONFIDENTIALITY
---------------
6.1 Subject to the provisions of Article 6.3 and except as otherwise
provided under this Agreement, any and all confidential information given by
either party to the other under this Agreement shall not be disclosed to any
third party and shall not be used for purposes other than the fulfillment of
obligations under this Agreement.
24
6.2 The following information is excluded from the provisions of Article
6.1:
a) information which, at the time of disclosure, is in the public
domain;
b) information which, after disclosure, becomes part of the public
domain by publication or otherwise, except by breach of this Agreement;
c) information which a party can establish by competent proof was
in its possession at the time of disclosure and was not acquired, directly
or indirectly, from the other party or acquired from any third party
subject to any obligation of confidentiality to the disclosing party;
d) information which is required by law, administrative or judicial
order to be disclosed, provided that such disclosure is subject to all
applicable governmental or judicial protection available for like material
and the party relying on this exception notifies the other party in writing
in advance of such intended disclosure, promptly after the notifying party
becomes aware of the disclosure requirement; or
e) information which is independently developed by the receiving
party without the aid, application or use of information disclosed by the
other party.
6.3 The parties agree to disclose or make available any confidential
information received under this Agreement only to
25
those of their employees, agents, sublicensees and consultants to whom it shall
be reasonably necessary in order to facilitate their performance hereunder and
only after they have undertaken to comply with all of the confidentiality
obligations hereunder.
6.4 The provisions of this Article 6 shall survive the expiration or
termination of this Agreement for a period of five (5) years.
ARTICLE 7
ADDITIONAL DOCUMENTS
--------------------
7.1 Where required by law, LICENSEE and LICENSOR agree to execute or
cause to be executed, at LICENSEE's cost and expense, all documents, including
but not limited to documents related to the Trademark(s), local license
agreements and local technical service agreements in order to allow the parties
to perform all of their obligations and exercise their respective rights under
this Agreement.
ARTICLE 8
INDEMNITY/INSURANCE
-------------------
8.1 LICENSOR hereby agrees to indemnify, save, defend and hold
LICENSEE and its directors, officers and employees (a "LICENSEE Indemnified
Party") harmless from and against any and all suits, claims, actions, demands,
liabilities, expenses (including legal fees) and/or losses resulting from (i)
the breach by LICENSOR of any covenant, representation or warranty contained in
this Agreement, (ii) any negligent act or omission of LICENSOR (or any Affiliate
thereof) in the manufacture of a
26
Product or any other activity conducted by LICENSOR under this Agreement, (iii)
the failure of a Product manufactured by LICENSOR for the Territory to meet the
Product Specifications for such Product, or (iv) the successful enforcement by a
LICENSEE Indemnified Party of any of the foregoing.
8.2 LICENSEE hereby agrees to indemnify, save, defend and hold LICENSOR
and its directors, officers and employees (a "LICENSOR Indemnified Party")
harmless from and against any and all suits, claims, actions, demands,
liabilities, expenses (including legal fees) and/or losses resulting from (i)
the breach by LICENSEE of any covenant, representation or warranty contained in
this Agreement, (ii) the negligent promotion, handling, storage, disposal,
marketing and/or sale of a Product or any other activity conducted by LICENSEE
under this Agreement, or (iii) the successful enforcement by a LICENSOR
Indemnified Party of any of the foregoing.
8.3 Each party shall, during the term of this Agreement, maintain
commercially reasonable amounts of insurance (but not less than $5,000,000) from
a reputable insurance carrier (or, in the case of LICENSEE, maintain a self-
insurance program) for liability insurance, including products liability and
contractual liability insurance adequately covering such party's obligations
under this Agreement. If during the term of this Agreement LICENSOR
demonstrates that it has sufficient financial resources to adopt a self-
insurance program for such insurance requirements, LICENSEE shall not
unreasonably withhold its
27
consent to the adoption by LICENSOR of such a program. Each party shall provide
the other party with evidence of such insurance or self-insurance program, upon
request.
8.4 The respective indemnification obligations of the parties hereto in
this Article 8 shall survive the termination or expiration of this Agreement for
ten years.
ARTICLE 9
BREACH/REMEDIES
---------------
9.1 In addition to the termination rights granted under Article 12.2,
any material breach by a party hereto of its obligations or representations
hereunder shall grant the other party the right to seek all remedies available
under applicable law including but not limited to compensation for all losses
and damages suffered by the non-breaching party, costs and expenses (including
attorneys' fees). With respect to any claim by one party against the other
arising out of the performance or failure of performance of the other party
under this Agreement, the parties expressly agree that the liability of such
party to the other party for such breach shall be limited under this Agreement
or otherwise at law or equity to direct damages only and in no event shall a
party be liable for, indirect, incidental or consequential damages, including
without limitation, lost profits.
28
ARTICLE 10
RECALLS/ADVERSE REACTIONS
-------------------------
10.1 In the event that any governmental agency or authority issues a
recall or takes similar action in connection with any quantity of either Product
in the Territory, LICENSEE shall advise LICENSOR immediately in writing, and
LICENSOR and LICENSEE shall agree on an appropriate course of action. LICENSOR
shall bear all expenses of any recall unilaterally requested by it and not
concurred in by LICENSEE acting reasonably, or of any recalls caused by
LICENSOR's gross negligence or misconduct. LICENSEE shall bear all expenses of
any recall unilaterally requested by it and not concurred in by LICENSOR acting
reasonably, or of any recall caused by LICENSEE's gross negligence or
misconduct. The expenses of all other recalls shall be equally shared between
LICENSOR and LICENSEE. For the purposes of this Agreement, expenses of recall
to be borne by the parties hereunder include, without limitation, the expenses
of notification and destruction or return of the recalled Product but not the
expenses or service fees associated with personnel time, which shall be borne by
the party incurring the same.
10.2 The parties hereby agree that the following terms will govern
disclosures of each party to the other with respect to adverse event reporting
relating to each Product:
A. An Adverse event ("AE") is defined as:
1. any experience which is adverse, including what are commonly
described as adverse or undesirable experiences, adverse
29
events, adverse reactions, side effects, or death due to any cause associated
with, or observed in conjunction with the use of a drug, biological product, or
device in humans, whether or not considered related to the use of the Product:
(i) occurring in the course of the use of the Product,
(ii) associated with, or observed in conjunction with Product
overdose, whether accidental or intentional,
(iii) associated with, or observed in conjunction with Product
abuse, and/or
(iv) associated with, or observed in conjunction with Product
withdrawal.
2. any significant failure of expected pharmacological or biological
therapeutic action (with the exception of in clinical trials).
B. Serious or Non-Serious is defined as:
1. A serious AE is one that is life threatening or fatal, permanently
disabling, requires in-patient hospitalization or prolonged hospitalization, or
is a congenital anomaly, cancer or overdose. In addition, end organ toxicity,
including hematological, renal, hepatic, and central nervous system AEs, may be
considered serious. In laboratory tests in animals, a serious AE includes any
experience suggesting significant risk for human subjects.
30
2. A non-serious AE is any AE which does not meet the criteria for a
serious AE.
C. Life-threatening is defined as: the patient is at immediate risk of
death from the AE as it occurs.
D. End-Organ Toxicity is defined as: A medically significant event or lab
value change in which a patient may not necessarily be hospitalized or disabled,
but is clinically significant enough to warrant monitoring (e.g. seizures, blood
dyscrasias).
E. Expected or unexpected is defined as:
1. Expected AE - An AE which is listed in the Investigator's Brochure
for clinical trials, included in local labelling (e.g., Summary of Product
Characteristics) for Marketed Drugs, or in countries with no local labelling, in
the Corporate Standard Prescribing Document.
2. Unexpected AE - An AE that does not meet the criteria for an
expected AE or an AE which is listed but differs from that event in terms of
severity or specificity.
F. Associated with or related to the use of the drug is defined as: A
reasonable possibility exists that the AE was caused by the Product.
G. Un-associated or unrelated to the use of the Product is defined as one
that does not meet the criteria for associated or related to the use of the
Product.
10.3 All initial reports and follow-ups (oral or written) for any and all
serious and unexpected AEs (other than with
31
respect to animal studies) which become known to a party (other than from
disclosure by or on behalf of the other party) must be communicated by telephone
or telefax to the other party within twenty four (24) hours upon receipt of the
information by the disclosing party with written confirmation to follow as soon
as it becomes available, but in no event later than three days after initial
communication of the AE.
10.4 For AEs from animal studies which suggest a potential significant
risk for humans, a written report must be forwarded to the other party as soon
as the results are received by the party making the report.
10.5 Within thirty (30) days of receipt of a request from the other party,
but not more often than as required by any regulatory agency, each party will
give the other party a print out or computer disk of all AEs reported to it and
its Affiliates relating to either Product within the last year.
10.6 If either party wishes access to AE reports of the other party
relating to a Product, upon request of that party the other party shall make
available its records (including computer disks) for viewing and copying by the
other party.
10.7 Disclosure of information hereunder by a party to the other party
shall continue as so long as either party and/or its Affiliates or designees
continue to clinically test or market a Product. LICENSEE's obligations
regarding AE reporting relate to territories in the world that are the subject
of a license or
32
other commercial relationship for Product between LICENSOR and LICENSEE.
10.8 LICENSEE shall make timely submissions of safety reports to
regulatory authorities in the countries in the Territory as required by local
law. LICENSEE shall notify investigators of safety reports as required by local
law. LICENSEE shall notify LICENSOR of any such reports.
ARTICLE 11
LICENSOR'S REPRESENTATIONS
--------------------------
11.1 By entering into this Agreement, LICENSOR represents that, subject
to obtaining the X-X Consent (as defined in Section 22.1), neither this
Agreement nor the transactions contemplated hereunder conflict with or violate
or will conflict with or violate the terms of any existing oral or written
commitment, obligation, arrangement, understanding or contract to which LICENSOR
or any of its principals is a party or by which any of them or the Products are
bound, or would require LICENSEE to make to any third party any payment of
royalty, or any compensation whatsoever as a result hereof.
ARTICLE 12
TERM/TERMINATION.
-----------------
12.1 Subject to the other provisions of this Agreement and of this Article
12, this Agreement shall be effective, for each country of the Territory, as of
the Effective Date and year first above written and shall be in full force and
effect with respect to the Products for a period of fifteen (15) years from the
date
33
of first commercial sale of the first Product in such country, provided,
however, that the term of this Agreement shall be extended for one additional
year, on a country by country basis, for each country in which (i) the first
commercial sale of the second Product in such country shall have been made more
than one year after the first commercial sale of the first Product in such
country and (ii) LICENSOR shall have met all of its obligations under Section
12.4 with respect to both Products.
12.2 Either party shall have the right to terminate this Agreement by
giving to the other not less than ninety (90) days' prior written notice in the
event that the other shall, at any time, commit a material breach of any of its
obligations hereunder (other than a material breach which would give rise to a
right of LICENSOR to terminate this Agreement in whole or in part under Section
12.4 hereof) and fail to cure such material breach during the period of said
notice.
12.3 This Agreement may be terminated without further notice by either
party if the other should become insolvent or should make or seek to make an
arrangement with or an assignment for the benefit of creditors; or if
proceedings in voluntary or involuntary liquidation or pursuant to any other
insolvency law shall be instituted by, on behalf of or against the other party
or if a receiver or trustee of the other party' s property shall be appointed.
12.4 This Agreement may be terminated upon written notice by LICENSOR to
LICENSEE as to a particular country or countries
34
with respect to a particular Product or Products if LICENSEE has failed to file
an application for marketing approval of such Product in such country within one
year from the receipt by LICENSEE of a Health Registration Dossier; if however,
the applicable regulatory authority in a country requires, as to a Product,
proof of regulatory approval or of a free sale certificate (or its equivalent)
from some other jurisdiction or requires that LICENSEE conduct additional
clinical trials or imposes any additional regulatory requirement, LICENSOR's
rights to terminate as to such Product provided in this sentence shall not arise
until one year from LICENSEE's receipt of proof of such regulatory approval or
of such free sale certificate (or its equivalent), completion of such additional
clinical trials or fulfillment of such additional requirement. LICENSEE shall
use diligent efforts to achieve approvals for each Product in each country in
the Territory. If LICENSEE is required to conduct additional clinical trials in
a country in the Territory prior to filing for marketing approval of a Product,
LICENSEE shall use diligent efforts to conduct such trial(s), provided the
conduct of such trials is commercially reasonable. If the conduct of such trials
is not commercially reasonable and LICENSEE has not achieved Net Sales with
respect to a Product in such country as required hereunder, LICENSOR shall have
the right to terminate LICENSEE's rights with respect to such Product in such
country. Subject to suspension of performance hereunder for any period during
which Force Majeure requires suspension of performance,
35
this Agreement shall expire as to any country with respect to a Product if Net
Sales of such Product are not made in such country by the earlier of: three (3)
years from the date on which LICENSEE received a Health Registration Dossier
from LICENSOR for such Product or six months from the date on which such Product
may first be sold legally and pricing and/or reimbursement approvals have been
received by LICENSEE in such country in the Territory.
12.5 This Agreement may be terminated by LICENSEE with respect to a
Product in one or more countries in the Territory upon 90 days written notice to
LICENSOR.
ARTICLE 13
POST-TERMINATION OBLIGATIONS
----------------------------
13.1 Upon a partial or full termination of this Agreement for any reason
whatsoever or upon expiration of the same, LICENSOR shall, at its option, either
(i) grant LICENSEE the right to fully exhaust or cause to be exhausted all
stocks of each Product on hand on the date of termination or expiration in each
country of the Territory as to which the termination or expiration applies, as
well as the right to use any stocks of packaging materials, excipients and
labels (hereafter "Materials") on hand in the manufacture of such Products or
(ii) re-purchase such stocks of each such Product and Materials at a price to be
mutually agreed by the parties.
13.2 Subject to the provisions of this Article 13.2 and the rights which
may be granted to LICENSEE pursuant to Article 13.1
36
(i), upon the expiration or full or partial termination of this Agreement,
LICENSEE and its Affiliates (i) shall not themselves, or in association with any
other person or entity, use the Trademarks relating to any terminated Product in
any country of the Territory as to which the termination or expiration applies,
and (ii) shall not register in any terminated country in the Territory any
trademark which is confusingly similar to the Trademarks relating to any such
terminated Product, and (iii) shall transfer and assign to LICENSOR, without
charge, all of their rights, title and interest in such Trademarks in each such
country in the Territory and shall execute all such instruments and agreements
as shall be necessary or appropriate to effectuate the transfer of ownership to
LICENSOR in and to such Trademarks and to cancel any applicable recorded
licenses or Registered User Agreements for such Trademarks; it is agreed that
this covenant shall survive the termination or expiration of this Agreement, for
so long as LICENSOR has valid enforceable rights to the Trademarks in the
Territory.
13.3 Upon the expiration or a partial or full termination of this
Agreement, LICENSEE and its Affiliates (i) shall transfer and assign to
LICENSOR, all registrations and permits or similar documentation necessary for
the sale of each Product in each country of the Territory as to which the
expiration or termination applies, including without limitation, health
registrations (applications and approvals), pricing and/or reimbursement
approvals and permits; (reasonable out-of-pocket
37
costs of such transfer and assignments shall be borne by LICENSOR); (ii) in the
event LICENSEE is manufacturing a Product hereunder as to which the expiration
or termination applies, LICENSEE shall cooperate with LICENSOR to achieve an
orderly transition of the manufacturing process and ensure supply of such
Product in the Territory; (iii) shall provide LICENSOR with samples of
promotional materials used for each Product in each country in the Territory as
to which the expiration or termination applies; (iv) shall provide LICENSOR with
customer lists developed for marketing each Product in each country in the
Territory as to which the expiration or termination applies; and (v) shall
perform such other actions and shall execute, acknowledge and deliver all such
assignments, transfers, consents and other documents as may be reasonably
necessary to effectuate an orderly transfer to LICENSOR of all rights necessary
to commercialize the Products in each country in the Territory as to which the
expiration or termination applies (reasonable out-of-pocket costs of such
assistance shall be borne by LICENSOR).
13.4 Upon any termination or expiration of this Agreement, LICENSEE shall
submit payment to LICENSOR for any earned but unpaid royalties or milestones.
ARTICLE 14
INDEPENDENCE OF PARTIES
-----------------------
14.1 It is agreed that the parties hereto are independent contractors and
engage in the operation of their own respective businesses. Neither of the
parties hereto shall be considered
38
the agent of the other nor shall it have authority to enter into any contract or
assume any obligation for the other party or make any warranties or
representations on behalf of the other party. Moreover, nothing in this
Agreement shall be construed to establish a relationship of co-partners or joint
venturers between the parties.
ARTICLE 15
NON-WAIVER
----------
15.1 Either party's failure, at any time, to exercise or enforce any
right conferred upon it hereunder, shall not be deemed to be a waiver of any
such right or operate to bar the exercise or performance thereof at any time or
times thereafter, nor shall its waiver of any right hereunder at any given time,
including rights to any payment, be deemed a waiver thereof for any other time.
ARTICLE 16
ASSIGNMENT
----------
16.1 Subject to the provisions of this Article 16, neither this Agreement
nor any of the rights or obligations hereunder shall be assigned by either party
by judicial process or otherwise, to any person, firm, company or corporation
without the prior written consent of the other party, except that LICENSOR shall
have the right to assign this Agreement in the event (i) LICENSOR is absorbed by
merger into a third party other than into any of its Affiliates, or (ii)
LICENSOR sells, transfers and assigns all of its assets including all its
rights,
39
title and interest to the Product to any third party other than any of
LICENSOR's Affiliates, or (iii) there is a change in the stock ownership of
LICENSOR so that such ownership falls under the "control" of a third party other
than any of LICENSOR's Affiliates. For the purposes hereof, the term "control"
shall have the same meaning as that set forth in Article 1.1.
16.2 LICENSEE and LICENSOR shall have the right to assign this Agreement
to any of their respective Affiliates.
ARTICLE 17
SEVERABILITY
------------
17.1 If any provision of this Agreement shall be deemed ineffective or
invalid, the remaining provisions hereof shall not be affected thereby and shall
continue to be in full force and effect.
ARTICLE 18
GOVERNING LAW/ARBITRATION.
--------------------------
18.1 In the event that any controversy or claim shall arise under, out of,
or in connection with, or relating to this Agreement or the breach thereof, the
party initiating such controversy or making such claim shall provide to the
other party a written notice containing a brief and concise statement of the
initiating party's claims, together with relevant facts supporting them. During
a period of thirty (30) days, or such longer period as may be mutually agreed
upon in writing by the parties, following the date of said notice, the parties
shall make good faith efforts to settle the dispute. Such efforts will
40
include, but shall not be limited to, full presentation of both parties' claims
and responses, with or without the assistance of counsel, before the President
of Schering-Plough International, Inc. and the President of LICENSOR. If the
parties are unable to reach accord using the procedures set forth in this
Section, either party may initiate arbitration proceedings in accordance with
Section 18.2 hereof by so serving notice on the other party.
18.2 This Agreement shall be governed by and construed in accordance with
the laws of the State of New York. Any disputes between the parties arising in
connection with this Agreement shall be settled through arbitration to be held
in New York under the rules of the American Arbitration Association. Any
arbitration award shall be final and binding on the parties. The documented
costs and expenses arising from arbitration shall be borne by the losing party.
ARTICLE 19
NOTICES
-------
19.1 Any notices required or permitted to be given hereunder, shall be in
writing and shall be sent by telefax and reconfirmed within forty-eight (48)
hours by prepaid registered air mail (return receipt requested) or recognized
courier service to the following addresses or to such other addresses as the
parties may communicate to each other as per the provisions herein. All notices
shall be deemed served five (5) days after telefax transmission.
41
To LICENSOR: U.S. BIOSCIENCE, INC.
One Tower Bridge
000 Xxxxx Xxxxxx, 0xx Xxxxx
Xxxx Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Attn.: President
Telefax: (000) 000-0000
Copy to: U.S. BIOSCIENCE, INC.
One Tower Bridge
000 Xxxxx Xxxxxx, 0xx Xxxxx
Xxxx Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Attn.: General Counsel
Telefax: (000)000-0000
To LICENSEE: SCHERICO, LTD.
0000 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Attn.: President,
Schering-Plough International, Inc.
Telefax: (000) 000-0000
Copy to: SCHERING-PLOUGH CORPORATION, INC.
Law Department
0000 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Attn.: Senior Legal Director, Licensing
Telefax: (000) 000-0000
ARTICLE 20
AMENDMENT
---------
20.1 No amendment, change, modification or alteration of the terms and
conditions of this Agreement shall be binding upon LICENSOR or LICENSEE unless
in writing and signed by a duly authorized officer of the party to be charged.
ARTICLE 21
GOVERNMENT APPROVALS
--------------------
42
21.1 This Agreement and all obligations herein shall be subject to and
conditioned upon the receipt of any and all required approvals from the
applicable governmental authorities of the Territory or any agency,
instrumentality or subdivision thereof. All registration fees and/or stamp
duties in connection with the registration of this Agreement shall be paid by
LICENSEE.
ARTICLE 22
CONSENTS AND APPROVALS
----------------------
22.1 The parties hereto represent that they have obtained all required
consents and approvals, including but not limited to their own corporate and
third parties' required approval (if any) to enter into this Agreement,
provided, however, that the consent of Xxxxxx-Xxxxxxx Company (the "X-X
Consent") is required in connection with the addition of the Product NeuTrexin
to this Agreement and is being sought by the parties contemporaneously with the
amendment and restatement of this Agreement effected as of November 6, 1997.
ARTICLE 23
PRESS RELEASES/ANNOUNCEMENTS
----------------------------
23.1 All press releases, or other written or verbal public announcements
relating to this Agreement and the transactions hereunder, and the method of
release for publication thereof will be subject to the written approval of the
parties hereto, which approval shall not be unreasonably withheld. Nothing in
the foregoing shall prohibit a party from making such disclosures to
43
the extent deemed necessary under applicable federal or state securities laws;
in such event, however, the disclosing party shall use good faith efforts to
consult with the other party prior to such disclosure.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
as of the date first above written.
U.S. BIOSCIENCE, INC. SCHERICO, LTD.
By: /s/C. Xxxx Xxxxxx By: /s/ Xxxx-Xxxx Xxxxxx
-------------------------- ----------------------------
As its: President & COO As its: President
---------------------- ------------------------
44
ANNEX I
-------
Patent Rights
CRYSTALLINE AMIFOSTINE COMPOSITIONS AND METHODS FOR THE PREPARATION AND USE OF
SAME
App. # App. Date
------ ---------
South Africa 93/5532 July 30, 1993
PCT Designated States
---------------------
Australia PCT/US93/07222 July 20, 0000
Xxxxxxx (not filed)
Bulgaria
Czech Republic
Hungary
Kazakhstan
Mongolia
New Zealand
O.A.P.I. (all)
Poland
Romania
Russian Federation
Slovak Republic (not filed)
Ukraine (not filed)
WATER-SOLUBLE SALTS OF 2,4-DIAMINO-5-METHYL-6-((3,4,5-
TRIMETHOZYANILINO)METHYL)QUINAZOLINE, COMPOSITIONS CONTAINING SUCH SALTS AND THE
PRODUCTION OF SUCH SALTS
Patent No. P10/1987, granted on November 1, 1987 by the Zanzibar government
(Zanzibar)
45
ANNEX II
--------
Territory
---------
Eastern Europe
- Bulgaria
- Czech Republic
- Hungary
- Poland
- Romania
- Slovakia
- As to the Product Ethyol, any country within the USSR immediately prior
to its dissolution on December 25, 1991
- As to the Product NeuTrexin, any country within the USSR immediately
prior to its dissolution on December 25, 1991 except: Azerbaijan,
Kazakistan (Kazakhstan), Kyrgyzstan, Turkmenstan and Uzbekistan
- Any country within the territory of the former Yugoslavia, including
without limitation:
Bosnia-Herzegovina
Croatia
Serbia
Slovenia
Macedonia
Montenegro
Australia
Iran
Iraq
New Zealand
South Africa, including the following homelands and former homelands:
Bophuthatswana
Lesotho
Swaziland
Transkei
Venda
Botswana
Namibia
Zimbabwe
Algeria
Cameroon (OAPI)
Ivory Coast (OAPI)
Malawi
Morocco
Senegal (OAPI)
Tanzania
Tunisia
Zambia
46
EXHIBIT 1.13
RELEASE SPECIFICATIONS FOR THE PRODUCTS
47
EXHIBIT 2.3
Fully Absorbed Cost shall be calculated in accordance with applicable Generally
Accepted Accounting Principles ("GAAP"), is defined as:
Included:
---------
1. Direct raw materials, actives (including intermediates), excipients and
labelling and packaging materials (vials etc.).
2. Direct labor costs.
3. Costs for quality control and stability testing.
4. Indirect labor costs, production supplies and chemicals, and general
factory overhead. These costs should be allocated to Product based upon
methodology in current practice within the manufacturing site which will
generally be in accordance with GAAP. Such allocation may be based upon
direct labor hours, machine hours or such other methodology as the
companies may agree in advance in writing.
Excluded
--------
1. Idle and excess capacity.
2. Manufacturing start-up costs.
3. Costs of research batches which are part of Product development (unless
such batches are used by Licensee for product development or research
activities within the Territory).
48
