EXHIBIT 10.12
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR
CONFIDENTIAL TREATMENT.
LICENSE AGREEMENT
THIS LICENSE AGREEMENT is made as of the 31st day of May, 2001 by and
between BENTLEY PHARMACEUTICALS, INC., a Delaware corporation, with offices at
00 Xxxxxxxxx Xxxx, 0xx Xxxxx, Xxxxx Xxxxxxx, Xxx Xxxxxxxxx 03862-2403
(hereinafter, "BENTLEY" or "Licensor"), and AUXILIUM A2, INC., a Delaware
corporation having a principal place of business at 000 X. Xxxxxxxxxx Xxxx,
Xxxxx X-0, Xxxx Xxxxxxxx, Xxxxxxxxxxxx 00000 (hereinafter, "AUXILIUM" or"
Licensee"). BENTLEY and AUXILIUM may be referred to as a "Party" or,
collectively, as "Parties."
RECITALS
WHEREAS AUXILIUM is engaged in the research, development, manufacture, marketing
and sale of pharmaceutical products;
WHEREAS BENTLEY is engaged in the development of pharmaceutical formulations and
drug delivery systems and has developed certain formulations which contain a
therapeutic drug and drug delivery systems included under BENTLEY Patents and
BENTLEY Technology;
WHEREAS under a Research Services Agreement of even date herewith (the "Research
Agreement") BENTLEY will prepare and test certain formulations which contain the
therapeutic drug dihydrotestosterone and CPE-215 (hereinafter, the "Compound")
under BENTLEY Patents and BENTLEY Technology;
WHEREAS AUXILIUM wishes to obtain a license under BENTLEY Patents and BENTLEY
Technology to undertake development of products containing the Compound which
meet criteria set forth in the Research Agreement for commercialization in the
Territory; and
WHEREAS BENTLEY is willing to grant such a license under certain terms and
conditions.
NOW, THEREFORE, in consideration of the premises and mutual covenants contained
herein, and INTENDING TO BE LEGALLY BOUND HEREBY, the Parties agree as follows:
ARTICLE I
DEFINITIONS
1.1 The following terms, as used herein, shall have the following meanings:
"Act" shall mean the United States Federal Food Drug and Cosmetic Act and
applicable regulations.
"Affiliate" means, when used with reference to a Party, any person directly
or indirectly Controlling, Controlled by or under common Control with a Party.
"Bankruptcy Event" means the person in question becomes insolvent, or
voluntary or involuntary proceedings by or against such person are instituted in
bankruptcy or under any insolvency law, or a receiver or custodian is appointed
for such person, or proceedings are instituted by or against such person for
corporate reorganization or the dissolution of such person, which proceedings,
if involuntary, shall not have been dismissed within one hundred eighty days
after the date or filing, or such person makes an assignment for the benefit of
creditors, or substantially all of the assets of such person are seized or
attached and not released within one hundred eighty days thereafter.
"BENTLEY Know-How" shall mean any and all present and future information
and any materials, including, without limitation, formulations, processes,
techniques, formulas, biological, chemical, assay control and manufacturing
data, methods, software, equipment designs, know-how, and trade secrets,
patentable or otherwise, tangible or intangible, that are owned or controlled by
Licensor that relate to the preparation, purification, characterization,
stabilization, processing, and formulation and/or use of a dihydrotestosterone
formulation containing CPE-215.
"BENTLEY Patents" shall mean United States Patent No. 5,023,252 and any and
all continuations, continuations-in-part, additions, divisions, renewals,
extensions, re-examinations and reissues thereof and any and all foreign
counterparts of the foregoing as set forth in Schedule A hereto and any other
Bentley U.S. or foreign patent application which is filed hereafter and which
includes a claim that covers a dihydrotestosterone formulation which contains
CPE-215 and/or the preparation and/or use thereof and any U.S. or foreign patent
issuing therefrom and any renewal, extension, re-examination or reissue thereof.
"BENTLEY Technology" means BENTLEY Know-How and Improvements.
"Calendar Quarter" means each three-month period, or any portion thereof,
beginning on January 1, April 1, July 1 and October 1.
"Combination Products" means any and all pharmaceutical compositions which
contain: (A) dihydrotestosterone as an active ingredient in combination with any
other products; and (B) the Compound; and which fall within the scope of any
composition, method, or article claim of the BENTLEY Patents.
"Compound" is defined above in the Recitals.
"Confidential Information" means (i) BENTLEY Technology, (ii) any other
information or material in tangible form that is confidential or proprietary to
the furnishing Party at the time it is delivered to the receiving Party, (iii)
proprietary information of the furnishing party, (iv) information that is
furnished orally if the furnishing party identifies such information as
confidential or proprietary when it is disclosed, and (v) patent applications
not yet in the public domain.
"Control", "Controlling," and "Controlled by" mean the direct or indirect
ownership of over 50% of the outstanding voting securities of an entity, or the
right to receive over 50% of the profits or earnings of a person, or the right
to control the policy decisions of a person.
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"Effective Date" means the date of receipt by BENTLEY of written notice
from AUXILIUM pursuant to Section 5.1 of the Research Agreement that it wishes
to proceed with development of Product.
"Improvement" shall mean any formulations and/or any enhancement or other
desirable change to the technical/pharmacological characteristics of
formulations of Product, whether patentable or not, which is useful for
commercializing Product developed by BENTLEY during the term of this Agreement
which may take the form of, without limitation, new or improved methods of
administration, manufacture, improved shelf life or packaging.
"IND" shall mean an Investigational New Drug Exemption application filed
under the Act, or comparable filing in any major market in the Territory the
approval of which permits clinical investigation of Product in humans.
"NDA" means a New Drug Application submitted under the Act to permit
commercial sale of Product in the United States or a comparable marketing
license in another major market in the Territory.
"Net Sales Price" means the gross amount charged by Licensee for the sale
of a Product, net of returns and credits for rejected goods, and after deducting
(i) trade and quantity discounts actually allowed, (ii) sales, use or value
added taxes, the legal obligation of which is on Licensee, and (iii) freight
allowances, insurance and customs duties, to the extent any of the foregoing are
identified on the invoice for the product. If a product is sold for
consideration other than solely cash, the fair market value of such other
consideration shall be included in the Net Sales Price. If a Product is sold in
a package or kit containing another product which is not a Product, the Net
Sales price for purposes of calculating the royalty under Section 3.2 hereof
shall be calculated by multiplying the Net Sales Price of the combination
product by the fraction of A/A+B, where "A" is the Net Sales Price of Product
when sold separately "B" is the Net Sales Price of the other product or products
when sold separately. If either the Product or the other product is not sold
separately, the Net Sales Price of the Product shall be negotiated in good faith
by the Parties.
"Person" or "Persons" means any corporation, partnership, joint venture or
natural person.
"Products" means any and all pharmaceutical compositions which contain (A)
dihydrotestosterone as the single active drug ingredient; and (B) the Compound;
and which fall within the scope of any composition, method or article claim of
the BENTLEY Patents.
"Sale" or any variation thereof means the sale, assignment, lease or other
disposition of a Product by Licensee to a non-Affiliate. A Product shall be
deemed to have been sold for purposes of calculating royalties under Article III
hereof upon the first to occur of the following: (i) the transfer of title in
the Product from Licensee to a non-Affiliate; or (ii) shipment of the Product
from the manufacturing facilities of Licensee to a non-Affiliate.
"Territory" shall mean all countries and territories of the world.
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"Use Patents" shall mean any patent granted in the Territory for the use of
the Product in a specific therapeutic indication.
ARTICLE II
GRANT OF LICENSE
2.1 Grant of License. Subject to the terms and conditions contained in this
Agreement, the Licensor hereby grants to Licensee a sole and exclusive,
worldwide, royalty-bearing license under BENTLEY Patents and BENTLEY Technology
with the right to sublicense to make, have made, use and sell Products in the
Territory pursuant to the terms and conditions of this License Agreement. In
addition, Licensee shall have the exclusive right to enter into another License
Agreement with BENTLEY to acquire rights in BENTLEY Patents and BENTLEY
Technology for the development of Combination Products, such right to expire
upon the termination of this Agreement. Licensor and Licensee agree to negotiate
the terms of such License Agreement in good faith.
2.2 Disclosure of BENTLEY Know-How. Promptly following the Effective Date
BENTLEY shall make available to Licensee any and all BENTLEY Know How not
disclosed under the Research Agreement to enable Licensee to develop Products.
ARTICLE III
PAYMENTS IN CONSIDERATION FOR LICENSE
3.1 Payments. In partial consideration for the license rights granted
hereunder, Licensee shall make the following non-refundable payments to Licensor
within ten (10) days after the following achievement in the development of the
first Product: *
3.2 Royalties. In further consideration for the license rights granted
under this Agreement Licensee shall also pay to Licensor the following royalty
amounts on annual Net Sales of Products in those countries in the Territory in
which
(a) there is an enforceable BENTLEY Patent at the time of sale:
* Million of Annual Net Sales * %
* Million of Annual Net Sales * %
Net Sales over the * Million of Annual Net Sales * %
(b) there is no enforceable BENTLEY Patent in the country when there
is an enforceable BENTLEY Patent in another country at the time of sale:
All Annual Net Sales over * Million * %
* Confidential information has been omitted and filed confidentially with the
Securities and Exchange Commission.
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(c) there is no enforceable BENTLEY Patent in any country at the time
of sale:
All Annual Net Sales over * Million * %
3.3 Royalty Payments. Royalties under this Agreement shall be paid within ninety
(90) days in the case of no sublicense, and one hundred twenty (120) days, in
the case of royalties received from a sublicensee, following the last day of the
Calendar Quarter in which the royalties and other amounts accrue. The last such
payment shall be made within ninety (90) days after termination of this
Agreement. Payments shall be deemed paid as of the day on which they are
received by Licensor in the manner designated by Section 3.4. Licensor and
Licensee agree to negotiate in good faith any future implication on royalties
caused by withholding taxes.
3.4 Currency, Place of Payment, Interest.
(a) All dollar amounts referred to in this Agreement shall be
expressed in United States dollars. All payments to the Licensor under this
Agreement shall be made in United States dollars, as directed by the Licensor,
by wire transfer to the Licensor or in such other manner as the Licensor may
designate from time to time.
(b) If Licensee receives revenues from sales of Products in a currency
other than United States dollars, royalties shall be converted into United
States dollars at a quarterly conversion rate for each foreign currency
calculated as the daily average of the noon buying rate in New York City for
cable transfers in foreign currencies as certified for customs purposes by the
Federal Reserve Bank in New York. These exchange rates are published at
xxx.xxxxxxxxxxxxxx.xxx/xxxxxxxx/X00/xxxx.
(c) Amounts that are not paid when due shall accrue interest from the
due date until paid, at an annual rate equal to the Prime Rate plus 1% as
published at xxx.xxxxxxxxxxxxxx.xxx/xxxxxxxx/X00/xxxxxx under the caption "Bank
Prime Loan." Historical rates are published at
xxx.xxxxxxxxxxxxxx.xxx/xxxxxxxx/X00/xxxx.xxx.
* Confidential information has been omitted and filed confidentially with the
Securities and Exchange Commission.
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3.5 Records. Licensee will maintain complete and accurate books and records
which enable the royalties payable hereunder to be verified. The records for
each Calendar Quarter shall be maintained for three years. Upon reasonable prior
notice to Licensee, the Licensor and its accountants shall have access to the
books and records of Licensee necessary to enable Licensor to verify the
royalties paid hereunder. Such access shall be available during normal business
hours from time to time during the term of this Agreement, and, during the
period from expiration or termination of this Agreement until three years after
such date, not more often than once each calendar year. If it is ultimately
determined that Licensee has underpaid royalties by 10% or more, Licensee will
pay the costs and expenses of the Licensor's accountant in connection with its
review or audit of the sales records of the Product, together with any interest
as provided in Section 3.4 (c) above.
3.6 Co-Marketing. In the event Licensee enters into a co-marketing or
sub-license arrangement with a third party, the royalty payments due to Licensor
will be calculated using Net Sales of Product of Licensee and Net Sales of
Product of Licensee's co-marketing partner combined.
ARTICLE IV
CERTAIN OBLIGATIONS OF LICENSEE
4.1 Government Approvals. Licensee will be responsible for obtaining, at its
cost and expense, all governmental approvals required for marketing and sale of
Products in the Territory.
4.2 Licensee Efforts.
(a) Licensee shall use its reasonable best efforts to develop for
commercial sale and to market Products in the Territory, and to continue to
market Products as long as commercially viable, all in a manner consistent with
sound and reasonable business practices. For purposes of this Agreement
reasonable best efforts in the case of Product development in any major market
shall mean at least that diligence required on the part of an NDA applicant in
undertaking the development of a drug product to qualify for the maximum patent
term extension under the Act.
(b) Licensee shall notify Licensor within thirty (30) days after the
first commercial sale of a Product and of any formal written notice from the FDA
or other equivalent regulatory authority ("Regulator") in which CPE-215 is the
Regulator's primary focus, apart from the use of CPE-215 in the Licensee's
Product.
ARTICLE V
WARRANTIES AND REPRESENTATIONS
5.1 Mutual Representations. Each of the Parties hereto represents, warrants and
covenants:
(i) It is a corporation or entity duly organized and validly existing under the
laws of the state or other jurisdiction of its incorporation or formation.
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(ii) The execution, delivery and performance of this Agreement by such Party has
been duly authorized by all requisite corporate action.
(iii) It has the power and authority to execute and deliver this Agreement and
perform its obligations hereunder.
(iv) The execution, delivery and performance by such Party of this Agreement
does not and will not conflict with or result in breach of the terms and
provisions of any other agreement or constitute a default under (a) a loan
agreement, guaranty, financing agreement, affecting a product or other agreement
or instrument binding or affecting it or its property; (b) the provisions of its
charter or operative documents or bylaws; or (c) any order, writ, injunction or
decree of any court or governmental authority entered against it or by which any
of its property is bound.
(v) The execution, delivery and performance of this Agreement by such Party does
not require the consent, approval or authorization of, or notice, declaration,
filing or registration with, any governmental or regulatory authority in the
Territory and the execution, delivery and performance of this Agreement does not
violate any law, rule or regulation applicable to such Party.
(vi) This Agreement has been duly authorized, executed and delivered and
constitutes such Party's legal, valid, and binding obligation enforceable
against it in accordance with its terms subject, as to enforcement, to
bankruptcy, insolvency, reorganization and other laws of general applicability
relating to or affecting creditors' rights and to the availability of particular
remedies under general equity principles.
(vii) It shall comply with all applicable laws and regulations relating to its
activities under this Agreement.
(viii) Each warrants that it is not debarred and has not and will not use in any
capacity the services of any person debarred under subsections 306 (a) and (b),
of the Generic Drug Enforcement Act of 1992. If at any time during the term of
this Agreement this warranty is no longer accurate, the affected party shall
immediately notify the other.
5.2 BENTLEY Warranties
(i) BENTLEY Patents. BENTLEY represents and warrants that: (a) BENTLEY is the
owner of all right, title and interest in and to the BENTLEY Technology and
BENTLEY Patents; and (b) BENTLEY has not received any written notice that the
Technology or Patents infringes the proprietary rights of any third party nor is
the Licensor in any other way aware of any infringement of third party
proprietary rights; (d) there are no claims, judgments or settlements against or
owed by BENTLEY, or pending or threatened claims, or litigation, relating to
BENTLEY Patents.
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ARTICLE VI
INSURANCE
6.1 Insurance Requirements for Licensee. Prior to commencing work with Product
in human clinical trials under this Agreement and during the entire term of this
Agreement and for a period of three (3) years thereafter, AUXILIUM, at its sole
expense, shall maintain in full force and effect with an insurance company or
companies having an A. M. Best Rating of "A-: Class VII" or better and supply a
Certificate of Insurance to BENTLEY evidencing Product Liability insurance
(including coverage for human clinical trials and contractual liability)
coverage in the amount of one million dollars ($1,000,000) per each occurrence
and in the general aggregate, respectively, during the clinical trial phase and
prior to commercialization of the Products and three million dollars
($3,000,000) per each occurrence and in the general aggregate, respectively,
once the Products are commercialized. Endorsement shall be furnished reflecting
the inclusion of BENTLEY, its officers, directors and employees as additional
insured. The policy providing the above insurance shall be endorsed to contain
the following undertaking: "It is agreed that this insurance will not be
cancelled, materially changed or non-renewed without at least thirty (30) days
notice to BENTLEY, by certified mail-Return Receipt Requested." Any type of
insurance or increase in liability limits not described in the foregoing which
AUXILIUM requires for its own protection shall be its own responsibility and at
its sole expense. The minimum insurance amounts specified herein shall not be
deemed a limitation on AUXILIUM'S indemnification liability under this Agreement
6.2 Insurance Requirements for Licensor. Prior to commencing work with Product
in human clinical trials under this Agreement and during the entire term of this
Agreement and for a period of three (3) years thereafter, BENTLEY, at its sole
expense shall maintain in full force and effect with an insurance company or
companies having A. M. Best Rating of an "A-: Class VII" or better and supply a
Certificate of Insurance to AUXILIUM evidencing Product Liability insurance
(including coverage for human clinical trials and contractual liability)
coverage in the amount of one million dollars ($1,000,000) per each occurrence
and in the general aggregate, respectively, during the clinical trial phase and
prior to commercialization of the Products and three million dollars
($3,000,000) per each occurrence and in the general aggregate, respectively,
once the Products are commercialized. The policy providing the above insurance
shall be endorsed to contain the following undertaking: "It is agreed that this
insurance will not be cancelled, materially changed or non-renewed without at
least thirty (30) days notice to AUXILIUM, by certified mail-"Return Receipt
Requested". Any type of insurance or increase in liability limits not described
in the foregoing which BENTLEY requires for its own protection shall be its own
responsibility and at its sole expense.
ARTICLE VII
INDEMNIFICATION
7.1 Indemnification by BENTLEY. BENTLEY will indemnify and hold AUXILIUM, its
directors, officers, employees and agents harmless against any and all
liability, damage, loss, cost or expense (including reasonable attorney's fees)
resulting from any third party claims made or suits brought against AUXILIUM
which arise from an act or failure to act by BENTLEY or BENTLEY'S breach of its
representations, warranties or agreements contained herein.
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7.2 Indemnification by AUXILIUM. AUXILIUM will indemnify and hold BENTLEY, its
directors, officers, employees and agents harmless against any and all
liability, damage, loss, cost or expense (including reasonable attorney's fees)
resulting from any third party claims made or suits brought against BENTLEY
which arise from the breach of any of AUXILIUM'S representations, warranties or
agreements contained herein, or which arise out of the development, manufacture,
promotion, distribution, use, testing or sale, distribution or other disposition
of Product, including, without limitation, any claims, express, implied or
statutory, made as to the efficacy, safety or use to be made of Product, and
claims made by reason of any Product labeling or any packaging containing
Product. This indemnification obligation shall not apply where the basis for the
claim is the negligence or willful malfeasance of BENTLEY.
7.3 Limitations on Indemnification Obligations. BENTLEY AND AUXILIUM EACH AGREE
THAT IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR INDIRECT,
INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM A DEFAULT OR BREACH
OF THIS AGREEMENT.
7.4 Procedures. The indemnified Party shall notify the indemnifying Party of any
claim or action giving rise to a liability within fifteen (l5) days after
receipt of knowledge of the claim. If notice is not given within fifteen (15)
days, the indemnifying Party shall maintain its obligation to indemnify unless
such failure to timely notify has a material, adverse effect on the outcome of
the claim. The indemnifying Party shall control the defense or settlement of the
claim. However, the indemnifying Party shall not settle or compromise any such
claim or action in a manner that imposes any restrictions or obligations on the
indemnified Party without the indemnified Party's written consent. The
indemnified Party shall cooperate reasonably, assist and give all necessary
authority and reasonably required information.
ARTICLE VIII
INTELLECTUAL PROPERTY
8.1 Intellectual Property Rights. The inventorship of inventions
developed under this Agreement and relating to Products ("Inventions") shall be
determined in accordance with U.S. Law. Inventions made solely by employees of
BENTLEY or owned by BENTLEY ("BENTLEY Inventions") shall be the exclusive
property of BENTLEY. Inventions made solely by employees of AUXILIUM ("AUXILIUM
Inventions") shall be the exclusive property of AUXILIUM, except that AUXILIUM
Inventions that relate to the use of Products shall be the joint property of
AUXILIUM and BENTLEY, each with an undivided one-half interest. Inventions other
than BENTLEY Inventions and AUXILIUM Inventions shall belong jointly to BENTLEY
and AUXILIUM, each with an undivided one-half interest.
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ARTICLE IX
PATENTS, TRADEMARKS AND INFRINGEMENT
9.1 Prosecution of Patents.
(a) The Licensor shall be solely responsible for preparing,
prosecuting and maintaining the BENTLEY Patents.
(b) Each Party shall cooperate with the other Party to execute all
required papers and instruments and to make all required oaths and declarations
as may be necessary in the preparation and prosecution of all such patents and
other applications and protections referred to in this Section 9.1.
9.2 Ownership. Subject to Section 4.4, the Licensor shall retain all right,
title and interest in and to the BENTLEY Patents and any patents, copyrights and
other protections related thereto, regardless of which party prepares,
prosecutes or maintains the patents, copyrights or other protections related to
the BENTLEY Technology, subject to the express license granted to Licensee under
this Agreement.
(a) In the event of Licensor wishing to abandon any BENTLEY Patents,
Licensor will offer to assign to Licensee, free of charge, any such Patent prior
to effectuating the abandonment. Licensee will bear the costs connected to any
assignment hereunder. In the event that any of the BENTLEY Patents is assigned
to AUXILIUM and AUXILIUM decides thereafter to abandon the assigned Patent,
AUXILIUM agrees that, at the request of BENTLEY, it will offer to assign the
assigned Patent to a third party licensee that is licensed by BENTLY under the
assigned Patent as such third party licensee is identified by BENTLEY to
AUXILIUM.
9.3 Trademarks. Licensee shall have the right, in its sole discretion and at its
own expense, to select and register such trademarks as it wishes to employ in
connection with the sale of the Products throughout the Territory and Licensee
shall have legal and equitable ownership of the entire right, title and interest
in and to the trademarks and registrations Licensee elects to use. Licensee will
acknowledge BENTLEY'S CPE-215 by adding "CPE-215(TM), BENTLEY" to its listing of
ingredients wherever such listing is appropriate or used by Licensee. It is
hereby expressly agreed that this Section 9.3 shall survive the expiration or
termination of this Agreement.
9.4 Infringement of Patents. If either Party has knowledge of any infringement
of BENTLEY Patents or BENTLEY Technology, the Party having such knowledge shall
promptly inform the other of such infringement. The Parties shall thereafter
discuss what action should be taken, including whether any legal proceeding
should be instituted. If the Parties mutually agree on the course of action to
be taken in respect of any such infringement, they shall jointly select counsel
and equally share any expenses. Any settlement or recovery shall be shared
equally by the Parties. If either party determines to take action, but the other
Party does not desire to do so, the first Party may take action at its own
expense and through counsel of its own choice, and any settlement or recovery
shall in such case belong solely to the Party taking action.
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9.5 If one party institutes and carries on a legal proceeding to enforce a
BENTLEY Patent against an alleged infringing party, the other Party shall fully
cooperate with and supply all assistance reasonably requested by the Party
instituting and carrying or such proceeding.
ARTICLE X
CONFIDENTIALITY
10.1 Confidentiality
(a) Licensee and Licensor shall maintain in confidence and shall not
disclose to any third party the Confidential Information received pursuant to
this Agreement, without the prior written consent of the other Party except that
the Confidential Information may be disclosed only to those third parties (x)
who have a need to know the information in connection with the exercise of
rights and obligations under this Agreement and who agree in writing to keep the
information confidential to the same extent as is required of each Party under
this Section 10.1, or (y) to whom the Party is legally obligated to disclose the
Information. The foregoing obligation shall not apply to:
(i) information that is known to the other Party or independently
developed by the other Party prior to the time of disclosure, in each case, to
the extent evidenced by written records promptly disclosed to the other Party
upon receipt of the Confidential Information; or
(ii) information that becomes patented, published or otherwise part of
the public domain as a result of acts by a Party or a third person obtaining
such information lawfully as a matter of right; or
(iii) information that becomes patented, published or otherwise part
of the public domain as a result of acts by the Licensor or a third person
obtaining such information lawfully as a matter of right; or
(iv) information that is required by any law, rule, regulation, order,
decision, decree, or subpoena or other judicial, administrative or legal process
to be disclosed, provided, however that each Party, as applicable, gives the
other prompt written notice of such request/order to permit the other party to
seek a protective order or other similar order with respect to such Confidential
Information and thereafter discloses only the minimum Confidential Information
required to be disclosed in order to comply.
(b) Each Party will take all reasonable steps to protect the
Confidential Information of the other Party with the same degree of care it uses
to protect its own confidential proprietary information. Without limiting the
foregoing, each party shall ensure that all of its employees having access to
the Confidential Information of the other Party are obligated in writing to keep
such information confidential to the same extent as is required of each Party
under this Section 10.1.
10.2 Injunctive Relief. Because damages at law may be an inadequate remedy for
breach of any of the covenants, promises and agreements contained in Section
10.1 hereof, both the Licensor and Licensee shall be entitled to injunctive
relief in any state or federal court located within the District of Delaware,
including specific performance or an order enjoining the breaching Party from
any
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threatened or actual breach of such covenants, promises or agreements. Each of
the Licensee and the Licensor hereby waives any objection it may have to the
personal jurisdiction or venue of any such court with respect to any such
action. The rights set forth in this Section 10.2 shall be in addition to any
other rights which the Licensor and Licensee may have at law or in equity.
10.3 This Article X shall survive the expiration or termination of this
Agreement.
ARTICLE XI
TERM AND TERMINATION
11.1 Term. This Agreement and the licenses granted herein shall commence on the
Effective Date and shall continue in effect in perpetuity subject to earlier
termination under Section 11.2 hereof.
11.2 Termination by the Licensor or Licensee.
(a) Upon the occurrence of any of the events set forth below ("Events
of Default"), the Licensor shall have the right to terminate this Agreement by
giving written notice of termination, such termination effective with the giving
of such notice:
(i) In the event of nonpayment of any material amount payable to the
Licensor after completion of an audit provided for under Section 3.5 hereof,
which nonpayment is continuing thirty (30) calendar days after the Licensor
gives Licensee written notice of such non-payment.
(ii) In the event that Licensee fails to initiate clinical trials
within two (2) years of availability of final formulation in quantities adequate
for clinical testing and associated documentation for clinical trials, unless
such failure is outside of the control of Licensee.
(iii) In the event that Licensee does not submit an application for
marketing approval in a major market within a five (5) year period after the
Effective Date unless such failure to submit is outside of the control of
Licensee.
(iv) In the event that Licensee does not launch Product in a major
market within six (6) months after marketing approval.
(v) In the event that Licensee becomes subject to a Bankruptcy Event
provided, however, that so long as Licensor continues to receive royalty
payments from Licensee under this Agreement, such Bankruptcy Event shall not be
a basis for termination of this Agreement by Licensor.
(b) Upon the occurrence of any of the events set forth below ("Events
of Default"), Licensee shall have the right to terminate this Agreement by
giving written notice of termination, such termination effective with the giving
of such notice:
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(i) breach by Licensor of any covenant or any representation or
warranty contained in this Agreement that is continuing thirty (30) calendar
days after Licensee gives written notice of such breach;
(ii) Licensor fails to comply with the terms of the license granted
hereunder and such noncompliance is continuing thirty (30) calendar days after
Licensee gives notice of such noncompliance;
(iii) Licensor becomes subject to a Bankruptcy Event; or
(iv) the dissolution or cessation of operations by Licensor.
(d) No exercise by the Licensor or Licensee of any right of
termination shall constitute a waiver of any right of the Licensor or Licensee
for recovery of any monies then due to it hereunder or any other right or remedy
the Licensor or Licensee may have at law or under this Agreement.
ARTICLE XII
FORCE MAJEURE
12.1 Either Party shall be relieved of its obligations under this Agreement to
the extent that fulfillment of such obligations shall be prevented by strikes,
embargoes, riots, fires, floods, war, hurricanes, windstorms, acts or defaults
of common carriers, governmental laws, acts or regulations, shortages of
materials or any other occurrence, whether or not similar to the foregoing,
beyond the reasonable control of the Party affected thereby.
12.2 If either Party is prevented from fulfilling its obligations under this
Agreement by reason of a circumstance covered by this Article 12, the Party
unable to fulfil its obligations shall, upon the occurrence of any such
circumstances, promptly notify the other Party upon the cessation of such
circumstance and of the likely duration thereof, and shall promptly notify the
other party upon the cessation of such circumstance.
ARTICLE XIII
ADDITIONAL PROVISIONS
13.1 Arbitration.
(a) All disputes arising between the Licensor and Licensee under this
Agreement shall be settled by arbitration conducted in accordance with the Rules
of the American Arbitration Association. The Parties shall cooperate with each
other in causing the arbitration to be held in as efficient and expeditious a
manner as practicable.
(b) Licensee and Licensor each irrevocably and unconditionally
consents to the jurisdiction of any such proceeding and waives any objection
that it may have to personal jurisdiction or the laying of venue of any such
proceeding.
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13.2 Assignment. No rights hereunder may be assigned by the Licensee, directly
or by merger or other operation of law, except assignment to an Affiliate,
without the express written consent of the other Party, such consent not to be
unreasonably withheld; provided, however, without such consent, either Party may
assign this Agreement in connection with the sale of all or substantially all of
its assets or business or its merger or consolidation with another company. Any
prohibited assignment of this Agreement or the rights hereunder shall be null
and void. No assignment shall relieve Licensee or Licensor of responsibility for
the performance of any accrued obligations which they have prior to such
assignment. This Agreement shall inure to the benefit of permitted assigns.
13.3 No Waiver. A waiver by either Party of a breach or violation of any
provision of this Agreement will not constitute or be construed as a waiver of
any subsequent breach or violation of that provision or as a waiver of any
breach or violation of any other provision of this Agreement.
13.4 Independent Contractor. Nothing herein shall be deemed to establish a
relationship of principal and agent between the Licensor and Licensee, nor any
of their agents or employees for any purpose whatsoever. This Agreement shall
not be construed as constituting the Licensor and Licensee as partners, or as
creating any other form of legal association or arrangement which could impose
liability upon one Party for the act of the other Party.
13.5 Notices. Any notice under this Agreement shall be sufficiently given if
sent in writing by overnight courier, prepaid, first class, certified or
registered mail, return receipt requested, addressed as follows:
If to the Licensor, to:
BENTLEY PHARMACEUTICALS, Inc.
00 Xxxxxxxxx Xxxx, 0xx Xxxxx
Xxxxx Xxxxxxx, XX 00000-0000
Attention: President
If to the Licensee, to:
AUXILIUM A(2), Inc.
000 X. Xxxxxxxxxx Xxxx
Xxxxx X-0, Xxxxxxxx Office Center
Xxxxxxxxxx, XX 00000
Attention: President
Copy to General Counsel
or to such other addresses as may be designated from time to time by notice
given in accordance with the terms of this Section.
13.6 Severability. Any of the provisions of this Agreement which are determined
to be invalid or unenforceable in any jurisdiction shall be ineffective to the
extent of such invalidity or unenforceability in such jurisdiction, without
rendering invalid or unenforceable the remaining
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provisions hereof or affecting the validity or unenforceability of any of the
terms of this Agreement in any other jurisdiction.
13.7 Headings and Titles. Any headings and titles used in this Agreement are for
convenience or reference only and shall not affect its construction or
interpretation.
13.8 No Third Party Benefits. Nothing in this Agreement, express or implied, is
intended to confer on any person other than the Parties hereto or their
permitted assigns, any benefits, rights or remedies.
13.9 Governing Law. This Agreement shall be construed, governed, interpreted and
applied in accordance with the laws of the State of Delaware, without giving
effect to conflict of law provisions.
13.10 Counterparts. This Agreement shall become binding when any one or more
counterparts hereof, individually or taken together, shall bear the signatures
of each of the parties hereto. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original as against the party
whose signature appears thereon, but all of which taken together shall
constitute but one and the same instrument.
13.11 Entire Agreement. This Agreement is the entire agreement between the
parties regarding the subject matter herein, and supercedes all prior existing
understandings between the Parties relating to the subject matter hereof. This
Agreement may not be modified except in writing signed by both Parties.
13.12 Press Releases. The Parties will not disclose, via any press release or
public announcement, the existence of this Agreement or the Research Agreement
until the Effective Date.
IN WITNESS WHEREOF, the parties hereto have duly executed this License
Agreement as of the date first above written.
BENTLEY PHARMACEUTICALS, INC. AUXILIUM A(2), Inc.
By: /s/ XXXXXX XXXXXXX By: /s/ XXXXXXXXX X. XXXXXXX
------------------ ------------------------
Xxxxxx Xxxxxxx Xxxxxxxxx X. Xxxxxxx
Vice President & General Counsel Chief Executive Officer
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SCHEDULE A/APPENDIX A
BENTLEY PATENTS
COUNTRY PATENT NO. GRANT DATE EXPIRATION DATE
------- ---------- ---------- ---------------
Belgium 248,885 Aug. 5, 1992 Nov. 28, 0000
Xxxxxx 1,312,281 Jan. 5, 1993 Jan. 05, 0000
Xxxxxxx 167,343 Oct. 18, 1993 Nov. 28, 0000
Xxxxxx 248,885 Aug. 5, 1992 Nov. 28, 0000
Xxxxxxx P3,690,626.3 May 15, 1997 Nov. 28, 2006
Great Britain 2,192,134 Apr. 25, 1990 Nov. 28, 0000
Xxxxx 248,885 Aug. 5, 1992 Nov. 28, 0000
Xxxxx 2,583,777 Nov. 21, 1996 Nov. 28, 2006
Korea 84,759 Nov. 29, 1994 Nov. 28, 2006
Luxembourg WO 873,473 Nov. 11, 1987 Nov. 28, 0000
Xxxxxxxxxxx 666,813 Aug. 31, 0000 Xxx. 00, 0000
Xxxxxx Xxxxxx 5,023,252 June 11, 1991 Jun. 11, 2008
Other patents are filed as provisional applications or are in the preparation or
developmental stages and will be amended, if applicable, to this Agreement.
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