Exhibit 10.5b
LABORATOIRE ▇. ▇▇▇▇▇ - CEPHALON
LICENSE AGREEMENT - OUTLINE
Parties
Background
ARTICLE I - Definitions
1. Territory
2. Patents - Appendix A
3. Licensed Product
4. Combination Product
5. Improvements
6. Net Sales
7. Technical Information
8. Exclusive License
9. Compound
ARTICLE II - Grant of License
ARTICLE III - Registration of Licensed Product
1. Technical Information Furnished by ▇▇▇▇▇
2.a Reports on Licensed Product
2.b Notification concerning adverse reactions
2.c Notification concerning governmental actions
2.d Recalls and withdrawals
3.a ▇▇▇▇▇ Assistance on Applications for Approval to Market
CEPHALON to carry on local trials and regulatory filings at
its expenses
3.b Estimated Time Frame for CEPHALON to obtain Market Approval
3.c ▇▇▇▇▇ Right to terminate if Market Approval Not Obtained
Within Estimated Time Frame or on Failure to File IND
3.d Termination on failure to Market Within Reasonable Time
after Receiving Approval
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ARTICLE IV - Confidentiality
1. Confidential Technical Information
2. Reasonable Security Measures
3. ▇▇▇▇▇ Obligation to Hold CEPHALON Reports Confidential
4. Technical Information Identified as Confidential
ARTICLE V - Fees, Royalties and Royalty Payment Terms
l.a License Fee
l.b Royalty Rate on Net Sales of Licensed Product
2. Royalty Payable on Net Sales of Licensed Product for
________ from Marketing in Territory
3. Combination Product Royalty
4. Royalty Payment and Statement
5. No Multiple Royalties
6. No Royalties on Sales Between CEPHALON and sublicensees
7. Taxes on Royalty Payments
8. Sublicensee Payment on Behalf of CEPHALON
9. Records and Audit
ARTICLE VI - Duration and Termination
1. Duration
2. Termination for Breach
3. Survival of Obligations
4. Return of Confidential Information
ARTICLE VII - Patents and Improvements
1. ▇▇▇▇▇ Obligation to Maintain and Prosecute Patents
2. Third Party Infringement of Licensed Patents
3. Defense of Patent Infringement Claims
4. Unlicensed Competition - Royalty Relief
5. Infringement of Third Party Patents - Royalty Credit
6. Improvements
7. Patent term extensions
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* The confidential material contained herein has been
- omitted and has been separately filed with the Commission.-
ARTICLE VIII - Representations, Warranties and Indemnification
1. ▇▇▇▇▇ Representations and Warranties
2. CEPHALON Representations and Warranties
3.a ▇▇▇▇▇ Indemnification
3.b CEPHALON Indemnification
3.c Conditions to Indemnification
ARTICLE IX - Miscellaneous Provisions
1. Successors and Assigns
2. Governing Law
3. Modification or waiver
4. Notices
5. Supply of Compound
6. Force Majeure
7. Counterparts
8. Entire Agreement
9. Severability
ARTICLE X - Arbitration
Execution
APPENDIX A - PATENTS
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LICENSE AGREEMENT
AGREEMENT made this _____ day of January, 1993, by and between LABORATOIRE ▇.
▇▇▇▇▇, a French corporation (hereinafter called "▇▇▇▇▇") - ▇▇, ▇▇▇▇▇▇ ▇▇
▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇ - ▇▇▇▇▇ ▇▇▇▇▇▇▇-▇▇▇▇▇▇ - ▇▇▇▇▇▇ and CEPHALON, INC., a
Delaware corporation (hereinafter called "CEPHALON"), ▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇,
▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇.▇.▇.
WITNESSETH:
WHEREAS, ▇▇▇▇▇ has discovered and developed an original compound, modafinil
(INN) for which it owns patent rights in the U.S.A., such compound being useful
in the field of the central nervous system; and
WHEREAS, CEPHALON is interested in acquiring a license from ▇▇▇▇▇ in order to
develop, promote and market in the U.S.A. and Mexico products containing
modafinil as an active ingredient; and
WHEREAS, ▇▇▇▇▇ is agreeable to grant CEPHALON a license under terms and
conditions hereinafter set forth.
NOW, THEREFORE, the parties, in consideration of their respective covenants
contained herein, agree as follows:
ARTICLE I - DEFINITIONS
For purposes of this Agreement the following words and phrases shall have the
following meanings:
1. "Territory" shall mean the territory of U.S.A., its territories and
possessions, and Mexico.
2. "Patents" shall mean (i) patents and patent applications now or hereafter
owned or controlled by ▇▇▇▇▇ in the Territory, including but not limited to
those patents listed on Appendix A attached hereto, which cover the
Compound or a Licensed Product, or its method of manufacture or use, and
(ii) any continuation, continuation in part, divisional or reissue patent
application or patent of addition, or patent filed thereon and any
extension thereof and any patents issuing therefrom.
3. "Licensed Product" shall mean any pharmaceutical specialty (whether sold by
prescription, over-the-counter, or otherwise) containing the Compound.
4. "Combination Product" shall mean any Licensed Product containing the
Compound and one or more other pharmacologically active ingredients.
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5. "Improvements" shall mean compositions and processes pertaining directly to
the Licensed Product, and new techniques of using, applying or
administering the Licensed Product.
6. "Net Sales" shall mean the gross sales proceeds derived by CEPHALON and/or
its sublicensees from the sale of the Licensed Product in the Territory
while this Agreement is in effect, after deducting normal and customary
cash and trade discounts, returns, allowances, transportation and insurance
charges or allowances, if shown on the invoice for the sale, and sales,
excise, turnover or similar taxes, if any, paid or allowed by CEPHALON,
and/or its sublicensees directly in respect of such sales.
7. "Technical Information" shall mean all information, inventions, or
Improvements relating to the Licensed Product now or hereafter owned or
controlled by ▇▇▇▇▇, including but not limited to, chemical, biological,
physical, pharmacological and toxicological data, animal and clinical
studies, data and know-how concerning the manufacturing of Licensed
Product from the Compound including but not limited to manufacturing
processes and procedures.
8. "Exclusive License" shall mean that the right to develop, make, have made
for it, use and sell the Licensed Product from the Compound in the
Territory is granted to CEPHALON solely and exclusively (even as to ▇▇▇▇▇
and its affiliates).
9. "Compound" shall mean modafinil and/or any other similar compound, isomer
or salt thereof.
10. "Cephalon" shall mean Cephalon, Inc. and any entity controlled by Cephalon,
including any subsidiary or other entity as to which Cephalon owns at least
50% of the voting stock or the right to receive at least 50% of the
profits.
ARTICLE II - GRANT OF LICENSE
▇▇▇▇▇ hereby grants to CEPHALON an Exclusive License, including the exclusive
right to practice under Patents and Technical Information, to make or have made
for it the Licensed Products and/or Combination Products from the Compound, and
to use and sell Licensed Products throughout the Territory. The license granted
hereunder does not include the right to make or have made the Compound, except
that the license hereunder shall automatically be expanded to include such right
to the extent provided in paragraphs 11 or 13 of the Supply Agreement.
CEPHALON shall have the right to grant sublicenses as long as CEPHALON is
licensed hereunder, subject to the prior approval of
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▇▇▇▇▇, which shall not be unreasonably withheld. CEPHALON shall require its
sublicensees to abide by CEPHALON's obligations under this Agreement, and shall
be liable to ▇▇▇▇▇ for the thorough application by its sublicensees of such
obligations. CEPHALON shall forward to ▇▇▇▇▇ a copy of each such sublicense
within thirty (30) days after execution thereof.
ARTICLE III - REGISTRATION OF LICENSED PRODUCT
1. Upon execution of this Agreement and on a continuing basis, ▇▇▇▇▇ shall
promptly furnish to CEPHALON all available Technical Information. ▇▇▇▇▇
will ensure that any new preclinical or clinical data included in the
Technical Information received or generated after execution of this
Agreement is provided to CEPHALON promptly in order that it may be
included, if necessary, in the Investigational New Drug Exemption (IND) or
New Drug Approval (NDA) application. ▇▇▇▇▇ agrees to execute such documents
as CEPHALON may reasonably request in connection with such IND or NDA
applications.
2.a. During the term of this Agreement ▇▇▇▇▇ and CEPHALON also shall transmit
to each other reports regarding the development of the Licensed Product, at
least semi-annually.
2.b. During the term of this Agreement ▇▇▇▇▇ and CEPHALON agree to notify the
other party immediately, in English, of any information known to it
concerning any serious or unexpected side effect, injury, toxicity, or
sensitivity reaction, or any unexpected incidents, and the severity
thereof, associated with the clinical uses, studies, investigations, tests
and marketing of a Licensed Product or any product of ▇▇▇▇▇ or a licensee
of ▇▇▇▇▇ that contains the Compound, whether or not determined to be
attributable to the Compound. "Serious", as used in this paragraph, refers
to an experience which is life-threatening or results in death, permanent
or substantial disability, inpatient hospitalization, or prolongation of
hospitalization, or produces a congenital anomaly or cancer, or is the
result of an overdose. "Unexpected", is one that is not listed in the
current labeling for the Licensed Product and includes an event that may be
symptomatically and pathophysiologically related to an event listed in the
labeling but differs from the event because of increased frequency, greater
severity or specificity. Each party shall cooperate with the other to
resolve complaints received by the other party with respect to any Licensed
Products.
2.c. During the term of this Agreement, each party further agrees to immediately
notify the other party, in English, about any information such party
received (including information received from a licensee or a sublicensee
that is known to
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such party) regarding any threatened or pending action by a governmental
agency which may affect the safety and efficacy claims of a Licensed
Product or the continued testing or marketing of the Licensed Product. Upon
receipt of any such information, ▇▇▇▇▇ shall consult with CEPHALON in an
effort to arrive at a mutually acceptable procedure for taking appropriate
action; provided, however, that nothing contained herein shall be construed
as restricting either party's right to make a timely report of such matter
to any government agency or take other action that it deems to be
appropriate or required by applicable law or regulation.
2.d. In the event (i) any governmental or regulatory authority issues a request,
directive, or order that any Licensed Product be recalled or withdrawn from
the Territory, or (ii) a court of competent jurisdiction in a final,
nonappealable judgment orders a recall or withdrawal of any Licensed
Product from the Territory, or (iii) ▇▇▇▇▇ and CEPHALON agree that a
Licensed Product should be recalled or withdrawn from the Territory, the
parties shall take all appropriate corrective actions to effect the recall
or withdrawal. The costs and expenses of notification and destruction or
return of the recalled or withdrawn Product shall be borne by ▇▇▇▇▇ in the
Territory, if the recall or withdrawal resulted from a failure by ▇▇▇▇▇ to
comply with the manufacturing specifications or other breach by ▇▇▇▇▇
under this Agreement or the Supply Agreement. In all other cases, CEPHALON
shall pay the costs of recall or withdrawal of the Licensed Product in the
Territory.
3.▇. ▇▇▇▇▇ shall cooperate with CEPHALON and render assistance in connection
with the filing of applications with any governmental authority or agency
in the Territory which may be required for CEPHALON to obtain approval to
market the Licensed Product in the Territory. Further, ▇▇▇▇▇ agrees to
deliver a letter of authorization or other documentation to any
governmental authority or agency in the Territory to enable CEPHALON to
file, refer to or incorporate by reference all of ▇▇▇▇▇'▇ Technical
Information including data on file with any such agency or authority
concerning the Licensed Product in a Drug Master File or otherwise. In the
event ▇▇▇▇▇ supplements or modifies any such Drug Master File, ▇▇▇▇▇ agrees
to notify CEPHALON promptly that supplements or modifications have been
made.
3.b. CEPHALON shall use all reasonable efforts, consistent with full and
complete laboratory and clinical evaluations and standards for new drug
product development, applicable in the Territory, to obtain all approvals
which may be required to permit the sale of the Licensed Product in the
Territory. To that end, CEPHALON shall conduct, at its own expense, all
necessary trials in the Territory and proceed to regulatory
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filings for all current and future indications of the Licensed Products.
CEPHALON will endeavor to obtain such approvals in the Territory as
expeditiously as possible. Within six (6) months from the date of this
Agreement, CEPHALON will endeavor to file an application for
Investigational New Drug Application ("IND") with the U.S. Food and Drug
Administration (the "FDA") with respect to a Licensed Product. In addition,
CEPHALON will endeavor to file a New Drug Application ("NDA") with the FDA
within two (2) years from the date CEPHALON files the IND for such Licensed
Product, provided that CEPHALON shall not be deemed to be in breach of
these obligations if the FDA requires CEPHALON to submit any additional
preclinical data other than the data furnished by ▇▇▇▇▇ to CEPHALON
immediately following the execution of this Agreement, or for any other
reason outside of CEPHALON's control.
CEPHALON and ▇▇▇▇▇ shall negotiate in good faith to determine the structure
of any multi-country trials to be initiated in connection with future
indications of a Licensed Product, as well as the appropriate share of
costs to be funded by CEPHALON, taking into account the relative benefits
of the indication to each party.
3.c. If CEPHALON fails to make all reasonable efforts to file an IND or NDA for
a Licensed Product within the time periods specified and as provided in
paragraph 3.b above, then ▇▇▇▇▇ may as its sole remedy terminate this
Agreement in accordance with Article VI, paragraph 2. The time periods
specified in paragraph 2 of Article VI may be extended upon the mutual
consent of the parties.
3.d. If CEPHALON fails to market the Licensed Product within three (3) months of
the effective date of approval of an application including price
reimbursement approval (and assuming receipt from ▇▇▇▇▇ of Compound under
the Supply Agreement), to permit such sale, upon sixty (60) days notice,
▇▇▇▇▇ may as its sole remedy, terminate CEPHALON's Exclusive License in the
Territory, and upon ▇▇▇▇▇'▇ request (and to the extent permitted by law),
CEPHALON will thereupon transfer its rights and approvals concerning the
Licensed Product in the Territory to ▇▇▇▇▇ or its designated assignee.
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ARTICLE IV - CONFIDENTIALITY
1. During the term that this Agreement is in effect and after its termination
or expiration, CEPHALON shall keep the Technical Information it receives
from ▇▇▇▇▇ concerning the Licensed Product confidential and shall not use
or disclose it to others except:
(i) for carrying out the purpose of this Agreement; or
(ii) for furnishing data to governmental agencies as required; or
(iii) except to the extent that such information is:
(a) in the literature or generally known to the public prior to the
date of disclosure by ▇▇▇▇▇ to CEPHALON or becomes a part of the
literature or generally known to the public after the disclosure
through no fault of CEPHALON;
(b) known to CEPHALON prior to the date of disclosure by ▇▇▇▇▇;
(c) disclosed to CEPHALON by a third party legally entitled to
disclose such information to CEPHALON; or
(d) disclosed to third party consultants or agents who are necessary
or desirable for evaluation, registration and marketing of the
Licensed Product, if such third parties agree to keep the
information confidential to the same extent required by this
Agreement.
In addition, ▇▇▇▇▇ and CEPHALON agree that they will not disclose to any
third party the content, terms and conditions of this Agreement, except as
may be required by the U.S. securities and other applicable laws and except
as set forth above in this paragraph l(iii)(a).
2. ▇▇▇▇▇ and CEPHALON shall take all reasonable steps to eliminate the risk of
disclosure of each other's confidential information, including, without
limitation, ensuring that only employees with a need to know the
confidential information have access thereto and that such employees shall
sign or shall have signed confidentiality agreements to treat the
information confidentially.
3. During the term of this Agreement ▇▇▇▇▇ agrees to be reciprocally bound by
the above confidentiality as to any reports, data or other information
furnished to it by
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CEPHALON under this Agreement, provided ▇▇▇▇▇ and its licensees may use any
information contained in such reports as required to secure regulatory
approval to market the Licensed Product in any country not included in the
Territory. After the expiration or termination of this Agreement ▇▇▇▇▇
agrees to be reciprocally bound by the above confidentiality obligations
with respect to any business or financial information of CEPHALON furnished
by CEPHALON.
4. All documents containing Technical Information and furnished by ▇▇▇▇▇ to
CEPHALON shall be identified prominently as "CONFIDENTIAL".
ARTICLE V - FEE, ROYALTIES AND PAYMENT TERMS
1. For and in consideration of the license granted herein CEPHALON shall pay
to ▇▇▇▇▇ the following license fees and royalties:
a. CEPHALON shall pay to ▇▇▇▇▇ the following license fees:
- one million US dollars (USD 1.0 million) upon signature of this
Agreement,
- one million US dollars (USD 1.0 million) - First Anniversary of
the date of this Agreement,
- one million US dollars (USD 1.0 million) - Second Anniversary,
- One million US dollars (USD 1.0 million) - Third Anniversary,
- Two million US dollars (USD 2.0 million) - upon the first U.S.
FDA approval of a Licensed Product.
b. In addition, CEPHALON shall pay to ▇▇▇▇▇ a royalty on Net Sales of
Licensed Products by CEPHALON and/or its sublicensees, calculated at
the rate of five per cent (5%) during the first three years from the
date of first commercial sale of the first Licensed Product in the
Territory, and seven per cent (7%) thereafter.
2. Royalties shall be payable on Net Sales of Licensed Product in the
Territory for a period of fifteen (15) years from the date of the first
commercial sale of the first Licensed Product in the Territory. Thereafter,
CEPHALON's license
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granted under Article II hereof shall be fully paid-up and irrevocable as
to all Licensed Products.
3. Net Sales for each Combination Product shall be determined by multiplying
the Net Sales of such Combination Product by a fraction; the numerator of
the fraction shall be the cost to CEPHALON of the active substance supplied
by ▇▇▇▇▇, and the denominator shall be the total cost to CEPHALON of all
active ingredients contained in such Combination Product but in no event
shall the royalty be decreased to less than one-half (1/2) of the amount
obtained in applying the royalty rate under l.b above to the Net Sales of
the Combination Product. Costs shall be determined according to CEPHALON's
accounting methods for determining the cost of its pharmaceutical products.
4. Royalty payments shall be made in US Dollars within sixty (60) days after
the last day of June and December for royalties accruing on sales during
the six (6) preceding calendar months. Each royalty payment shall be
accompanied by a statement which shall set forth the gross sales, the
detail of deductions according to article 1.b, Net Sales, the royalty rate
and royalties payable in US Dollars. If CEPHALON receives Net Sales in a
currency other than US Dollars, royalties shall be calculated by using the
rate for converting such currency into US Dollars quoted as the New York
foreign exchange selling rate on the last business day of the royalty
period.
5. Only one royalty shall be payable for a Licensed Product, regardless of the
number of Patents that may apply to the Licensed Product or its
manufacture, use or sale.
6. No royalties shall be payable on sales between CEPHALON and its
sublicensees.
7. All taxes assessed, imposed on or required to be withheld from royalty
payments due ▇▇▇▇▇, will be deducted from the sums due, as far as such
amounts can be deducted from ▇▇▇▇▇'▇ taxes in France. Tax receipts will be
received by CEPHALON evidencing such payments which receipts will be
forwarded to ▇▇▇▇▇.
8. Any sublicensee of CEPHALON may, at CEPHALON's sole discretion pay in US
Dollars on behalf of CEPHALON any obligation of CEPHALON under this
Agreement and such payment shall be received by ▇▇▇▇▇ in lieu of payment by
CEPHALON with the same effect as if payment had been tendered by CEPHALON
in satisfaction of such obligation under this Agreement.
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9. CEPHALON shall, and shall require its sublicensees to, keep and maintain
records of sales made pursuant to the license and/or sublicenses granted
hereunder. Such records shall be open to inspection at any reasonable time
and upon reasonable notice (but not more than once each calendar year)
within three (3) years after the royalty period to which such records
relate, by an independent certified public accountant selected by ▇▇▇▇▇,
retained at ▇▇▇▇▇'▇ expense and approved by CEPHALON, such approval not to
be unreasonably withheld. Such accountant shall have the right to examine
the records kept pursuant to this Agreement only to verify the royalty
payments to be made by CEPHALON to ▇▇▇▇▇ hereunder. Such accountant shall
keep confidential all information it receives in the course of such
inspection and may report the findings of said examination of records to
▇▇▇▇▇ and to CEPHALON only insofar as it is necessary to evidence any
mistake or impropriety on the part of CEPHALON and/or its sublicensees.
ARTICLE VI - DURATION AND TERMINATION
1. Unless sooner terminated under paragraph 2 below, this Agreement shall
expire fifteen (15) years after the first commercial sale of the first
Licensed Product in the Territory, or upon the expiration of the
last-to-expire Patent licensed hereunder, whichever is later. CEPHALON's
fully paid-up and irrevocable license to Technical Information shall
survive such expiration in accordance with Article V, paragraph 2.
2. CEPHALON may terminate this Agreement at any time upon thirty (30) days
notice in writing to ▇▇▇▇▇, and ▇▇▇▇▇ may terminate this Agreement pursuant
to Article III, paragraphs 3.c. and 3.d. In addition, if either party
hereto shall fail to comply in any material respect with any of its
obligations under this Agreement and shall fail to remedy any such breach
within ninety (90) days after receipt of written notice thereof from the
other party, the party not in default shall have the right to terminate
this Agreement by giving written notice of termination. Notwithstanding the
foregoing, if CEPHALON shall have breached an obligation under Article 3
only in respect of one jurisdiction within the Territory, ▇▇▇▇▇ may
terminate this Agreement only with respect to such jurisdiction. In such
event, the definition of "Territory" shall automatically be amended to
delete such jurisdiction from and after such termination date.
3. The expiration or termination of this Agreement or any license granted
hereunder for any reason by either party shall not relieve the parties of
any obligation accruing prior to such expiration or termination.
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4. Upon termination of this Agreement under paragraph 2, CEPHALON shall (i)
stop using Technical Information and return to ▇▇▇▇▇ all documents in its
possession containing same, except to the extent retention of clinical data
or other Technical Information is required by applicable law, (ii) as soon
as practicable sell any remaining inventory of Licensed Products (subject
to its obligation to pay ▇▇▇▇▇ a royalty thereon), and (iii) if requested
by ▇▇▇▇▇, transfer to ▇▇▇▇▇ or any company designated by ▇▇▇▇▇ the product
registrations for Licensed Products in the Territory, to the extent
permitted by applicable law and at ▇▇▇▇▇'▇ expense. ▇▇▇▇▇ shall likewise
cease using any business or financial information related to CEPHALON and
shall return to CEPHALON all documents in its possession containing same.
5. The provisions of Article IV will survive the expiration or termination of
this Agreement, in accordance with their terms.
ARTICLE VII - PATENTS
1. ▇▇▇▇▇ shall maintain the Patents in the Territory and will prosecute any
patent applications included in the Patents. ▇▇▇▇▇ will keep CEPHALON fully
advised of the status of all Patents, will take all reasonable efforts to
send CEPHALON in advance drafts of any filing in the Territory related to
the Patents as well as copies of the filewrapper, and will consider the
suggestions of CEPHALON and its patent counsel with respect to the
prosecution and maintenance of the Patents. If ▇▇▇▇▇ fails to prosecute the
patent application or to maintain the Patents as required by this
Agreement, CEPHALON shall have the right to take over and prosecute any
such application or maintain any such Patents in ▇▇▇▇▇'▇ name.
2. In the event any of the licensed Patents are infringed in the Territory,
▇▇▇▇▇ agrees to immediately commence appropriate legal action to stop such
infringement at its sole expense, and CEPHALON shall assist it to do so, at
CEPHALON's expense. If ▇▇▇▇▇ fails to initiate such action within ninety
(90) days after being notified by CEPHALON of the infringement, CEPHALON
shall have the right to begin such action at its own expense at CEPHALON's
option, in the name of ▇▇▇▇▇, and the latter agrees to give CEPHALON its
complete cooperation, at ▇▇▇▇▇'▇ expense. Any damages or awards resulting
from the prosecution of such claim shall be applied first, to reimburse the
prosecuting party for its costs and expenses and any balance shall be
shared by the parties in proportion to their economic losses from such
infringement.
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3. Each party shall promptly notify the other party of any claim asserting
that the use of Compound in connection with a Licensed Product infringes
the proprietary rights of another person. ▇▇▇▇▇ shall defend any such claim
unless it determines, in its sole discretion, that it is not in its
interests to do so. If ▇▇▇▇▇ elects to defend a claim, the defense shall be
at ▇▇▇▇▇'▇ costs and expense, but CEPHALON may be represented by counsel in
an advisory capacity, at CEPHALON's expense. If ▇▇▇▇▇ does not elect to
defend such claim within 120 days after receiving notice (from CEPHALON or
otherwise) of such claim, CEPHALON may, but is not required to, defend such
claim. Any such defense shall be at the expense of CEPHALON (including
attorneys' fees), but CEPHALON shall keep ▇▇▇▇▇ informed of the status of
any such defense, and any damages or awards that are awarded to CEPHALON
resulting from the defense of such claim shall be the sole property of
CEPHALON. Either party assuming the defense of such claim may join the
other party as a defendant if necessary to defend such claim, but shall
indemnify and hold harmless the party so joined against attorneys' fees,
court costs or damages resulting from the use of such party's name in the
action.
4. If Licensed Product is sold by a third party or parties (whether unlicensed
or under a compulsory license) on a substantial commercial basis in a
country in the Territory during the period in which such sales continue,
the royalty payable on Net Sales in such country in the Territory during
the period in which such sales continue, the royalty payable on Net Sales
in the Territory shall be reduced to 2.5%. For purposes of this provision
"substantial commercial basis" shall mean forty per cent (40%) of unit
sales of Licensed Product in such country in the Territory for the
immediately preceding six calendar months.
5. In the event that CEPHALON or its affiliates are required during the term
of this Agreement to pay royalties to a third party for patents, or patent
applications owned or controlled by said third party covering the Licensed
Product, its method of use or production, such royalties shall be
creditable against any earned royalties payable under this Agreement in the
applicable country in the Territory but in no event shall the royalties due
▇▇▇▇▇ be reduced to less than one-half (1/2) of the royalties otherwise
payable to ▇▇▇▇▇ under the terms of this Agreement in such country in the
Territory.
6. CEPHALON and ▇▇▇▇▇ will advise each other periodically of any Improvements
made by either party patentable or not, and CEPHALON and ▇▇▇▇▇ agree to
grant the other party authorization to use such Improvements at no cost on
a nonexclusive basis. The licensees or sublicensees of a
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party shall be authorized to use an Improvement of the other party in their
respective territory or territories (but not in the territory of the party
who made the Improvement) if the licensee or sublicensee has agreed (as of
the date of this Agreement) to reciprocity with respect to its own
improvements related to Licensed Products, including the Compound.
7. CEPHALON and ▇▇▇▇▇ will cooperate to the extent required to obtain an
extension of the term of the Patents under the U.S. Drug Price Competition
and Patent Term Restoration Act.
ARTICLE VIII - REPRESENTATIONS & WARRANTIES; INDEMNIFICATION
1. ▇▇▇▇▇ represents and warrants to CEPHALON that: (a) the manufacture,
marketing, sale and use of the Licensed Products in the Territory do not,
to ▇▇▇▇▇'▇ knowledge, conflict with or infringe any intellectual property
rights of another and there is no pending or threatened claim or litigation
against ▇▇▇▇▇ with respect to the Patents or their use in connection with a
Licensed Product; (b) all of the Patents and Technical Information are
owned by ▇▇▇▇▇, free and clear of all liens or encumbrances, and no
interest in any of the Patents or Technical Information has been granted or
licensed to any third party in the Territory; (c) this Agreement, when
executed and delivered by ▇▇▇▇▇, will be the legal, valid and binding
obligation of ▇▇▇▇▇, enforceable against ▇▇▇▇▇ in accordance with its
terms; (d) ▇▇▇▇▇ has the authority to grant in the Territory the licenses
granted to CEPHALON of the scope set forth herein.
2. CEPHALON represents and warrants to ▇▇▇▇▇ that: (a) it is a corporation
duly organized, validly existing and in good standing under the laws of the
State of Delaware; (b) CEPHALON has full right and authority to enter into
this Agreement as herein described and is not a party to any agreement,
indenture or other instrument and has no by-law or charter provision and
knows of no law or regulation which would prohibit it from entering into
this Agreement; and (c) this Agreement has been duly authorized and when
executed and delivered will become a valid and binding contract of CEPHALON
enforceable against CEPHALON in accordance with its terms.
3.▇. ▇▇▇▇▇ will indemnify and hold harmless CEPHALON and its affiliates,
employees, officers, directors, and agents (a "CEPHALON Indemnified Party")
from and against any and all liability, loss, damages, costs or expenses
(including reasonable attorneys' fees) which the CEPHALON Indemnified Party
may incur, suffer or be required to pay that results from the breach by
▇▇▇▇▇ of its obligations hereunder or any
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of its representations or warranties contained in this Agreement.
3.b. CEPHALON will indemnify and hold harmless ▇▇▇▇▇ and its affiliates,
employees, officers, directors, and agents (an "▇▇▇▇▇ Indemnified Party")
from and against any and all liability, loss, damages, costs, or expenses
(including reasonable attorneys' fees) which the ▇▇▇▇▇ Indemnified Party
may incur, suffer or be required to pay resulting from or arising in
connection with any breach by CEPHALON of its obligations hereunder or any
of its representations or warranties contained in this Agreement.
3.c. The obligations of the indemnifying party under paragraphs 3.a. and 3.b.
above are conditioned upon the prompt notification to the indemnifying
party of any of the aforementioned suits or claims in writing within thirty
(30) days after receipt by the party's general counsel's office of notice
by the indemnified party of such suit or claim. The indemnifying party
shall have the right and obligation to defend any such suit or claim. The
indemnified party may participate in the defense of such suit or claim at
its sole cost and expense. This provision for indemnification shall be void
and there shall be no liability against a party as to any suit or claim for
which settlement or compromise or an offer of settlement or compromise is
made without the prior consent of the indemnifying party.
ARTICLE IX - MISCELLANEOUS PROVISIONS
1. Successors and Assigns
This Agreement shall be binding upon and inure to the benefit of the
successors and assigns of the parties hereto. This Agreement cannot be
assigned by any of the parties hereto without the prior approval of the
other party in writing; provided, however, that either party may, without
such consent, assign this Agreement in connection with the transfer or sale
of all or substantially all of its business or in the event of its merger
or consolidation with another company. Any purported assignment in
violation of the preceding sentence shall be void. Any permitted assignee
shall assume all obligations of its assignor under this Agreement. No
assignment shall relieve either party of responsibility for the performance
of any accrued obligation which such party then has hereunder.
Notwithstanding the foregoing, if prior to FDA approval of the initial
Licensed Product, CEPHALON (i) sells 60% or more of its tangible assets, or
(ii) participates in or becomes subject to a merger in which it is not the
surviving entity, the transaction may proceed without the consent of ▇▇▇▇▇
but, within ninety (90) days after such event, the parties
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(in the case of CEPHALON, any successor to CEPHALON) shall meet to review
the development and commercialization plans for the Licensed Product of the
successor entity. If the successor to CEPHALON does not wish to continue
aggressively the development and commercialization plans for the Licensed
Products on the same schedule as CEPHALON, it shall, upon request of ▇▇▇▇▇,
sublicense its rights under this Agreement (subject to the approval of
▇▇▇▇▇ in accordance with Article II), for a sublicense fee of no more than
l.5X CEPHALON's investment in the development of Licensed Products to the
date of such sublicensing in addition to any amounts due to ▇▇▇▇▇
hereunder.
2. Governing Law
This Agreement shall be governed by and construed in accordance with the
laws of France.
3. Modification or Waiver
No modification or waiver of any of the provisions of this Agreement shall
be valid unless in writing signed by the parties hereto or signed by the
party against whom enforcement of such modification or waiver is sought.
4. Notices
Notice hereunder shall be deemed sufficient if given by registered air
mail, postage prepaid, and addressed to the party to receive such notice at
the address given above, or at such other address as may hereafter be
designated by notice in writing.
5. Supply of Compound for Clinical Purposes
To enable CEPHALON to carry out its pharmacological, toxicological and
clinical experimentation for the Licensed Product, ▇▇▇▇▇ shall furnish
CEPHALON with reasonable quantities of the Compound used in the Licensed
Product. The terms and conditions of the supply and purchase of such
Compound are set forth in the Supply Agreement of even date herewith
between ▇▇▇▇▇ and CEPHALON, except that the Compound shall be provided free
of charge to CEPHALON.
6. Force Majeure
Neither party shall be liable to the other party for any delay in
performance or nonperformance of any of its obligations hereunder caused by
any act of God, explosion, fire, war, labor disputes, order or decree of
any court or governmental authority, or other unforeseeable cause wholly
beyond the control and without the negligence of such party provided the
party so affected promptly notifies the other party and uses its best
efforts to remove such cause as soon as reasonably practical. CEPHALON's
Exclusive License in the Territory shall not be subject to termination by
▇▇▇▇▇
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where CEPHALON's failure to perform is due to any of the foregoing causes.
7. Counterparts; Effectiveness
This Agreement shall become binding when any one or more counterparts
hereof, individually or taken together, shall bear the signatures of ▇▇▇▇▇
and CEPHALON. This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original as against any party whose
signature appears thereon, but all of which together shall constitute one
and the same instrument.
8. Entire Agreement
This Agreement, together with the Supply Agreement and the Trademark
Agreement, contain all of the covenants, terms and undertakings of the
parties with respect to the particular subject matter hereof and all prior
agreements among the parties relating to the subject matter hereof, whether
written or oral, are merged herein and shall be of no force and effect.
This Agreement cannot be changed, modified or discharged except by an
instrument in writing signed by both parties hereto.
9. Severability
If any provision of this Agreement or application thereof to anyone or
under any circumstances is adjudicated to be invalid or unenforceable, such
invalidity or unenforceability shall not affect any other provisions or
applications of this Agreement which can be given effect without the
invalid or unenforceable provision or application.
ARTICLE X - ARBITRATION
Any difference between the parties hereto concerning the interpretation or
application of this Agreement which could not be resolved amicably shall be
finally settled in accordance with the Rules of Conciliation and Arbitration of
the International Chamber of Commerce by three arbitrators designated in
accordance with said Rules. This Agreement shall be construed, and the rights of
the parties determined, in accordance with the French laws. Judgment upon the
award rendered may be entered in any court having jurisdiction thereof. The
place of arbitration will be Geneva.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate
as of the day and year first written above.
LABORATOIRE ▇. ▇▇▇▇▇ CEPHALON, INC.
By: /s/ ▇.▇.▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇.
--------------------------- ---------------------------
Name: ▇.▇.▇▇▇▇▇ Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇.
Title: Chief Executive Officer Title: President & CEO
Date: 1/20/93 Date: Jan 20th 1993
ATTEST ATTEST
By: [ILLEGIBLE] By: /s/ ▇▇▇▇ ▇▇▇▇
--------------------------- ----------------------------
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