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Exhibit 10.21
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DEVELOPMENT AND LICENSE
AGREEMENT
BETWEEN
CIMA LABS INC.
AND
AMERICAN HOME PRODUCTS CORPORATION
ACTING THROUGH ITS DIVISION
ESI LEDERLE
FOR
[...***...]
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DEVELOPMENT AND LICENSE AGREEMENT
THIS AGREEMENT is signed this 14th day of January 2000 between CIMA
LABS INC., a corporation organized and existing under the laws of the State of
Delaware with offices located at 1000 Valley View Road, Eden Prairie, Minnesota
55344 (hereafter, together with its Affiliates, referred to as ("CIMA"), and
American Home Products Corporation (acting through its division, ESI Lederle), a
corporation organized and existing under the laws of the State of Delaware with
offices located at 130 N. Radnor-Chester Road, St. Davids, Pennsylvania 19087
("ESI").
ARTICLE I
DEFINITIONS
1.1 [...***...]
1.2 ADVERSE EXPERIENCE means the definition in the current 21 CFR "
Sections 312.32 and 314.80, as in effect from time to time.
1.3 AFFILIATE means (i) any Person which at the time of determination
is directly or indirectly controlled by any party hereto; (ii) any Person which
at the time of determination directly or indirectly controls any party hereto;
or (iii) any Person which is under the direct or
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indirect control of any such Person as described in subparagraphs (i) or (ii).
Control in this Section means ownership of greater than fifty percent (50%) of
the voting stock or other voting interests in the Person in question.
[...***...]
1.4 AGENCY means any governmental regulatory authority responsible for
granting approvals, including Pricing Approvals, for the sale of the Product in
a country in the Territory.
1.5 [...***...]
1.6 CIMA PATENTS shall mean those Patents and Patent applications owned
or Controlled by CIMA during the Term of this Agreement that claim the Product,
its manufacture or method of use, including the Patents and Patent applications
which are set forth on Exhibit A hereto.
1.7 COMMERCIALLY REASONABLE EFFORTS means efforts and resources
normally used by a party for a compound or product owned by it or to which it
has rights, which is of similar market potential at a similar stage in its
product life, taking into account the competitiveness of the marketplace, the
proprietary position of the compound or product, the regulatory structure
involved, the profitability of the applicable products, and other relevant
factors. It is anticipated that the level of efforts and resources may change at
different times during the product life cycle of a compound or product.
1.8 CONTROL OR CONTROLLED in the context of intellectual property
rights means rights to intellectual property sufficient to allow a grant of
rights to a party.
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1.9 DIRECT COST means the costs for those items specified in Exhibit B,
which costs are calculated in accordance with U.S. generally accepted accounting
principles consistently applied.
1.10 EFFECTIVE DATE means the date determined in Section 14.10.
1.11 FDA means the United States Food and Drug Administration, or any
successor thereto.
1.12 GOOD CLINICAL PRACTICE OR GCP means the then current standards for
clinical trials for pharmaceuticals, as set forth in the United States Federal
Food, Drug and Cosmetics Act and applicable regulations promulgated thereunder,
as amended from time to time, and such standards of good clinical practice as
are required by the European Union and other organizations and governmental
agencies in countries in which Product is intended to be sold, to the extent
such standards are not inconsistent with United States GCP.
1.13 GOOD LABORATORY PRACTICE OR GLP means the then current standards
for laboratory activities for pharmaceuticals, as set forth in the United States
Federal, Food, Drug and Cosmetics Act and applicable regulations promulgated
thereunder, as amended from time to time, and such standards of good laboratory
practice as are required by the European Union and other organizations and
governmental agencies in countries in which Product is intended to be sold, to
the extent such standards are not inconsistent with United States GLP.
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1.14 GOOD MANUFACTURING PRACTICE OR GMP means the current standards for
the manufacture of pharmaceuticals, as set forth in the United States Federal,
Food, Drug and Cosmetics Act and applicable regulations promulgated thereunder,
as amended from time to time, and such standards of good manufacturing practices
as are required by the European Union and other organizations and governmental
agencies in countries in which Product is intended to be sold, to the extent
such standards are not inconsistent with United States GMP.
1.15 [...***...]
1.16 HSR ACT means the Hart-Scott-Rodino Antitrust Improvements Act of
1976, as amended, and the rules and regulations promulgated thereunder.
1.17 LAUNCH DATE means the date of first commercial shipment of the
Product by ESI or its Affiliates or their respective subdistributors to Third
Parties in a country in the Territory.
1.18 MAJOR COUNTRY means any of the United States, Germany, or the
United Kingdom. The foregoing countries may also collectively be referred to as
Major Countries.
1.19 [...***...]
Such amounts shall be determined from the books and records of ESI, its
Affiliates and their respective sublicensees and subdistributors maintained in
accordance with U.S. generally accepted accounting principles consistently
applied, and such amounts shall be calculated using the same accounting
principles used for other ESI products.
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[...***...] Where (i) Product is sold by ESI, its Affiliates or its
sublicensees and subdistributors other than in an arms-length sale or as one of
a number of items without a separate invoiced price; or (ii) consideration for
Product shall include any non-cash element, the Net Sales applicable to any such
transaction shall be deemed to be ESI's average Net Sales for the applicable
quantity of to the Product at that time.
1.20 PATENTS means all patents and patent applications, and all
additions, divisions, continuations, continuations in-part, pipeline protection,
substitutions, reissues, extensions, registrations, patent term extensions,
supplementary protection certificates and renewals of any of the above.
1. 21 PERSON means an individual, a corporation, a partnership, an
association, a trust or other entity or organization, including a government or
political subdivision or an agency thereof.
1.22 PRICING APPROVAL means any approval for price or reimbursement as
may be necessary or appropriate as a prerequisite for marketing the Product in a
particular country of the Territory.
1.23 [...***...]
1.24 REGULATORY APPROVAL means the product license or marketing
approval necessary as a prerequisite for marketing the Product in a particular
country in the Territory.
1. 25 REGULATORY DOCUMENTS means all regulatory submissions, Regulatory
Approvals, and Pricing Approvals.
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1.26 SPECIFICATIONS means the specifications for the Product as set
forth in Exhibit C hereto, as may be amended from time to time by the parties in
the course of Product development and in accordance with the regulatory
submissions and/or Regulatory Approvals, or as otherwise required by regulatory
authorities.
1.27 SUPPLY AGREEMENT means the agreement for the exclusive supply of
Product by CIMA to ESI between the parties and effective on the Effective Date.
1.28 TECHNICAL INFORMATION means (a) techniques and data, including
ideas, inventions (including patentable inventions), practices, methods,
knowledge, know-how, trade secrets, skill, experience, documents, apparatus,
clinical and regulatory strategies, test data, including pharmacological,
toxicological and clinical test data, analytical and quality control data,
manufacturing, patent data or descriptions relating to Product, and (b) chemical
formulations, compositions of matter, product samples and assays relating to
Product.
1.29 TERM shall have the meaning set forth in Section 10.1.
1.30 TERRITORY means the world.
1.31 THIRD PARTY means any Person other than a party to this Agreement
or an Affiliate of a party to this Agreement
1.32 $ means United States dollars.
ARTICLE II
GRANT OF RIGHTS; EXCLUSIVITY
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2.1 GRANT OF RIGHTS During the Term of this Agreement, CIMA hereby
grants to ESI, an exclusive license under the CIMA Patents and Technical
Information, and CIMA's interest in Joint Patent Rights, to market, promote,
use, distribute, sell, have sold and to import and export Product within the
Territory, provided that CIMA grants only a non-exclusive license under
[...***...] and corresponding patents throughout the world. In addition to the
foregoing, ESI shall have an exclusive license under the CIMA Patents ad
Technical Information, and CIMA's interest in the Joint Patent Rights, to make
(and to have made) Product in the Territory subject to, and in accordance with,
the provisions of Sections 2.4,11.3(b) and the applicable provisions of the
Supply Agreement.
2.2 SUBLICENSE RIGHTS The rights granted to ESI hereunder includes the
right to sublicense all or part of such rights [...***...]; provided that (a)
the terms and conditions of such grant of sublicense rights (i) are consistent
with and do not violate the terms and conditions of this Agreement, and (ii)
provide ESI with the right and obligation to enforce such terms and conditions;
(b) ESI remains primarily liable and responsible for the performance of any such
Affiliates and Third Parties according to the terms of this Agreement; and (c)
if ESI grants a sublicense to a Third Party, then ESI shall promptly notify CIMA
of the identify of the Third Party; provided, however that any sublicense of the
rights contained in Section 2.4 hereof or Section 2.9 of the Supply Agreement
shall be subject to the prior written consent of CIMA, such consent not to be
unreasonably withheld or delayed.
2.3 [...***...]
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2.4 [...***...]
ARTICLE III
DEVELOPMENT ACTIVITIES
3.1 DEVELOPMENT AND REGISTRATION RESPONSIBILITIES FOR THE PRODUCT Each
party agrees to use its Commercially Reasonable Efforts to perform its
obligations to develop, [...***...], and register the Product to meet the
timetable set forth in Exhibit D. Each party shall comply with all applicable
GLP, GCP and GMP in the conduct of the development of the Product. CIMA shall
(a) be responsible for conducting the ongoing development work for Product; (b)
design and conduct all dosage form, formulation, process, and chemistry
manufacturing and control (CMC) and related technical studies on Product,
including preparation of dosage form CMC regulatory documents, and conduct
scale-up activities for the manufacture of Product. ESI shall be responsible for
and shall (a) conduct all pivotal biostudies, and (b) file, own and maintain all
submissions for Regulatory Approval and Regulatory Approvals of Product in the
Territory. CIMA shall be responsible for providing the CMC and related technical
components of such submissions, as jointly determined by the parties, and ESI
shall be responsible for formatting such documentation for, and submitting such
documentation to, the appropriate Agencies in the Territory. The ANDA shall be
filed with CIMA as approved manufacturer. The parties shall cooperate with, and
assist, each other in connection with their activities hereunder including
addressing regulatory questions, and preparing updates and supplements to
regulatory
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filings for Product in the Territory. ESI, however, shall be responsible for all
communications with the FDA and post-Regulatory Approval regulatory requirements
in the Territory, including pharmacovigilance and Adverse Drug Experience
reporting, unless otherwise agreed in advance in writing by the parties.
3.2 [...***...]
ARTICLE IV
DILIGENCE OBLIGATIONS
4.1 PERFORMANCE OBLIGATIONS
(a) ESI shall, subject to supply by CIMA of launch quantities of
Product, use Commercially Reasonable Efforts to launch Product as soon as
commercially reasonable in each Major Country, within three (3) months following
the later of Regulatory Approval or if applicable, Pricing Approval, provided
the pricing is approved within ESI's global pricing limits. The Product must
also be free of all other legal and regulatory encumbrances.
4.2 RECORD KEEPING Each party shall record, to the extent practical and
customary in the industry, all Technical Information relating to the Product
development in written form, which writing shall be signed, dated and witnessed,
consistent with standard practices of each party. All such written records of
the parties shall be maintained in a form sufficient to satisfy Regulatory
Agencies.
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4.3 ADVERSE DRUG EXPERIENCES To the extent either party receives any
information regarding Adverse Drug Experiences related to the use of the
Product, such party shall promptly provide the other party with such information
in accordance with the Adverse Event Reporting Procedures set forth in Exhibit E
hereto (as may be amended from time to time upon written agreement of the
parties).
ARTICLE V
ROYALTY PAYMENTS TO CIMA
5.1 [...***...]
5.2 [...***...]
5.3 INSPECTION OF RECORDS The parties shall maintain at their offices,
accurate and complete books and records consistent with sound business and
accounting this Agreement by the respective party to be determined. ESI and CIMA
shall permit an independent certified accountant (subject to obligations of
confidentiality) appointed by the other party and reasonably acceptable to ESI
or CIMA (as applicable), at the other party's expense, to examine such books and
records at all reasonable times for the sole purpose of (i) verifying ESI's or
CIMA's (as applicable) reports and accounting submitted to the other party
hereunder and (ii) determining the correctness of payments. In the event of any
underpayment of any payment by at least five percent (5%), the costs of such
inspection shall be borne by the party who made such underpayment and such
underpayment shall be
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forthwith paid by such party to the other party with interest at the rate
specified in Section 5.5.
5.4 PAYMENTS Each party shall make all payments due to the other party
hereunder in $ by wire transfer in immediately available funds to an account
designated by the payee party.
5.5 INTEREST The parties shall pay interest on any amounts overdue
under this Agreement at a rate equal to the $ prime or equivalent rate quoted by
Citibank N.A. or another mutually acceptable bank, as in effect during the
period from the date due until payment.
5.6 EXCHANGE RATES All royalty payments to be made pursuant to this
Agreement shall be made in $. Amounts based on Net Sales in currencies other
than $ shall be converted to $ at the ESI financial statement exchange rates
applied by ESI on a consistent basis in ESI's own financial accounting on the
date such payment is due.
5.7 CURRENCY BLOCKAGE Where payments are due hereunder for sales of
Product in a country where, by reason of currency regulations or taxes of any
kind, it is impossible or illegal for ESI to transfer payments to CIMA in that
country, such payments shall be deposited by ESI in whatever currency is
allowable for the benefit or credit of CIMA in an accredited bank in that
country that is reasonably acceptable to CIMA.
5.8 WITHHOLDINGS Any and all income or similar taxes imposed or levied
on account of the receipt of payments under this Agreement which are required to
be withheld shall be paid by ESI on behalf of CIMA and shall be paid to the
proper taxing authority.
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Proof of payment shall be secured, if available, and sent to CIMA by ESI as
evidence of such payment in such form as required by the tax authorities having
jurisdiction over ESI. Such taxes shall be deducted from the payments that would
otherwise be remittable by ESI. ESI shall take reasonable measures to assist
CIMA in obtaining credit for such taxes against CIMA's United States tax
liabilities.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1 REPRESENTATION AND WARRANTIES OF EACH PARTY Each of CIMA and ESI
hereby represents, warrants and covenants to the other party hereto as follows:
(a) it is a corporation or entity duly organized and validly existing
under
(b) the laws of the state or other jurisdiction of incorporation or
formation;
(c) the execution, delivery and performance of this Agreement by such
(d) party has been duly authorized by all requisite corporate action
and does not
(e) require any shareholder action or approval;
(f) it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder; and
(g) the execution, delivery and performance by such party of this
Agreement and its compliance with the terms and provisions hereof does not and
will not conflict with or result in a breach of any of the terms and provisions
of or constitute a default under (i) a loan agreement, guaranty, financing
agreement, agreement affecting a product or other
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agreement or instrument binding or affecting it or its property (ii) the
provisions of its charter or operative documents or bylaws; or (iii) any order,
writ, injunction or decree of any court or governmental authority entered
against it or by which any of its property is bound.
6.2 REPRESENTATIONS AND WARRANTIES OF CIMA In addition to the
representations and warranties made by CIMA under Section 6.1 above, CIMA hereby
further represents and warrants to ESI that:
(a) As of the Effective Date, the CIMA Patents are existing and, to the
best of its knowledge, are not invalid or unenforceable, in whole or in part;
(b) It has the full right, power and authority to grant all of the
right, title and interest in the licenses granted under Article II hereof;
(c) It has not, prior to the Effective Date, previously assigned,
transferred, conveyed or otherwise encumbered its right, title and interest in
Product, or the CIMA Patents, or CIMA Technical Information, with respect to
which ESI has been granted a license or other rights hereunder in the Territory,
provided that CIMA has granted, and may in the future grant, licenses to Third
Parties under such CIMA Patents and CIMA Technical Information which licenses do
not conflict with the rights granted to ESI under this Agreement;
(d) It is the sole and exclusive owner of the CIMA Patents and
Technical Information existing as of the Effective Date, all of which are free
and clear of any liens, charges and encumbrances, except as provided in Section
6.2(c), and no other person,
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corporate or other private entity, or governmental entity or subdivision
thereof, has or shall have any claim of ownership with respect to the CIMA
Patents or Technical Information in the Territory, [...***...]
(e) To the best of its knowledge the CIMA Patents and Technical
Information do not, as of the Effective Date, interfere or infringe on anyvalid
intellectual property rights owned or possessed by any Third Party in the
Territory, [...***...]
(f) As of the Effective Date, there are no claims, judgments or
settlements against or owed by CIMA or, to the best of its knowledge, pending or
threatened claims or litigation relating to the CIMA Patents or Technical
Information;
(g) During the Term of this Agreement it will use Commercially
Reasonable Efforts not to diminish the rights under the CIMA Patents and
Technical Information licensed to ESI hereunder, by not committing or permitting
any actions or omissions which would cause the breach of any agreements between
itself and Third Parties which provide for intellectual property rights
applicable to the development, manufacture, use or sale of Product, that it will
provide ESI promptly with notice of any such alleged breach, and that as of the
Effective Date, it is in compliance in all material respects with any agreements
with Third Parties relating to the CIMA Patents and Technical Information.
6.3 REPRESENTATION BY LEGAL COUNSEL Each party hereto represents that
it has been represented by legal counsel in connection with this Agreement and
acknowledges that it has participated in the drafting hereof. In interpreting
and applying the terms and provisions of this Agreement, the parties agree that
no presumption shall exist or be implied
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against the party which drafted such terms and provisions.
ARTICLE VII
INDEMNIFICATION
7.1 INDEMNIFICATION BY ESI Except as provided in Section 9.3, ESI shall
indemnify, defend and hold harmless CIMA and its Affiliates, and each of its and
their respective employees, officers, directors and agents (each a "CIMA
Indemnified Party") from and against any all liability, loss, damage, cost and
expense (including reasonable attorney's fees) (collectively, a "Liability")
which the CIMA Indemnified Party may incur, suffer or be required to pay
resulting from or arising in connection with (i) the breach by ESI of any
representation or warranty contained in this Agreement, or (ii) the manufacture,
promotion, distribution, use, testing, marketing, sale or other disposition of
Product by ESI, its Affiliates or sublicensees. Notwithstanding the foregoing,
ESI shall have no obligation under this Agreement to indemnify, defend or hold
harmless any CIMA Indemnified Party with respect to claims, demands, costs or
judgments which result from either (x) the failure of Product supplied by CIMA
or its Affiliates to comply with the Specifications or the applicable Regulatory
Approvals or (y) the willful misconduct or negligent acts or omissions of CIMA,
its Affiliates, or any of their respective employees, officers, directors or
agents.
7.2 INDEMNIFICATION BY CIMA Except as provided in Section 9.3, CIMA
shall indemnify, defend and hold harmless ESI and its Affiliates, and each of
its and their respective employees, officers, directors and agents (each, a "ESI
Indemnified Party") from
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and against any Liability which the ESI Indemnified Party may incur, suffer or
be required to pay resulting from or arising in connection with the breach by
CIMA of any representation or warranty contained in this Agreement.
Notwithstanding the foregoing, CIMA shall have no obligation under this
Agreement to indemnify, defend, or hold harmless any ESI Indemnified Party with
respect to claims, demands, costs or judgments which result from the failure of
Active Ingredient supplied by ESI or its Affiliates to comply with the
Specifications or the applicable Regulatory Approvals, or from the willful
misconduct or negligent acts or omissions of ESI, its Affiliates, or any of
their respective employees, officers, directors or agents.
7.3 CONDITIONS TO INDEMNIFICATION The obligations of the indemnifying
party under Sections 7.1 and 7.2 are conditioned upon delivery of written notice
to the indemnifying party of any potential Liability promptly after the
indemnified party becomes aware of such potential Liability, provided, however,
that the failure to give such notice promptly shall not impair a party's rights
to indemnification under this Article VII unless the delay in providing such
notice has a material adverse effect on the ability of the indemnifying party to
defend against such Liability. The indemnifying party shall have the right to
assume the defense of any suit or claim related to the Liability if it has
assumed responsibility for the suit or claim in writing; however, if in the
reasonable judgment of the indemnified party, such suit or claim involves an
issue or matter which could have a material adverse effect on the business
operations or assets of the indemnified party, the indemnified party may waive
its rights to indemnity under this Agreement and control the
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defense or settlement thereof, but in no event shall any such waiver be
construed as a waiver of any rights such party may have as against any Third
Party at law or in equity. If the indemnifying party defends the suit or claim,
the indemnified party may participate in (but not control) the defense thereof
at its sole cost and expense.
7.4 SETTLEMENTS Neither party may settle a claim of action related to a
Liability without the consent of the other party, if such settlement would
impose any monetary obligation on the other party or require the other party to
submit to an injunction or otherwise limit the other party's rights under this
Agreement. Any payment made by a party to settle any such claim or action shall
be at its own cost and expense except in the event that such payment was made
with the prior written consent of the indemnifying party, in which case such
payment will be subject to the indemnification obligations of the parties as set
forth in this Article VII.
7.5 INSURANCE Each party further agrees to obtain and maintain, during
the term of this Agreement, Comprehensive General Liability Insurance, including
Products Liability Insurance, with reputable and financially secure insurance
carriers to cover its indemnification obligations under Section 7.1 or 7.2, as
applicable, [...***...]
ARTICLE VIII
CONFIDENTIALITY
8.1 NONDISCLOSURE During the Term of this Agreement and for a period of
five (5) years thereafter, all proprietary and confidential business, technical,
scientific and/or
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regulatory information, including Technical Information, disclosed to the
receiving party or its Affiliates (herein collectively, the (Receiving Party) by
the other party or its Affiliates (herein collectively, the (Disclosing Party)
hereunder or under the existing Confidentiality Agreement between the parties
which is marked as confidential at the time of disclosure, or if disclosed or
obtained orally or visually (or otherwise in a non-written form), was described
or summarized in a writing or other tangible form and identified as confidential
and forwarded to the Receiving Party within thirty (30) days of such disclosure
(collectively, Confidential Information), shall be deemed to be confidential and
shall be treated as such by the Receiving Party and shall not be disclosed, in
whole or in part, by the Receiving Party to any other Person except as expressly
set forth herein, and shall be used only for the purposes of this Agreement.
Notwithstanding the foregoing these mutual obligations of confidentiality shall
not apply to any information to the extent that such information is:
(i) independently developed by such party as documented by prior
written records outside the scope and not in violation of this Agreement;
(ii) legally in the public domain at the time of its receipt or
thereafter legally becomes part of the public domain through no fault of the
recipient;
(iii) received without an obligation of confidentiality from a Third
Party having the right to disclose such information;
(iv) released from the restrictions of this Article VIII by the express
written consent of the Disclosing Party;
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(v) as may be required for securing Regulatory Approval, or as may be
required to be disclosed to an Agency or as otherwise required by a court order
or any law or regulation (including, as may be required in connection with any
filings made with the Securities and Exchange Commission or by the disclosure
policies of a major stock exchange in the Territory); provided, however, that at
the other party's request, the disclosing party shall request that the relevant
legal or regulatory authority, or major stock exchange, treat as confidential
any Confidential Information of either party included in any such disclosure and
generally use diligent efforts to seek confidential treatment where available.
8.2 SCOPE OF CONFIDENTIALITY CIMA and ESI agree to limit the disclosure
of any Technical Information and other Confidential Information received
hereunder to such Affiliates, officers and employees as are necessary to carry
out the provisions of this Agreement and who are likewise bound by provisions
equivalent to this Article VIII, except that, with CIMA's written consent, which
shall not be unreasonably withheld or delayed, ESI may disclose Confidential
Information of CIMA to consultants, to distributors, and to actual or potential
sublicencees and subdistributors, provided that they are likewise bound by
confidentiality provisions similar to, or more stringent than, those set forth
in this Article VIII. The parties shall take reasonable measures to assure that
no unauthorized use or disclosure is made by Persons to whom access to such
Confidential Information is granted. Unauthorized use or disclosure by any
person who has been given access to Confidential Information by a Receiving
Party hereunder shall be deemed to be unauthorized use or
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disclosure by such Receiving Party, and the Receiving Party shall be responsible
to the Disclosing Party hereunder.
ARTICLE IX
TECHNOLOGY AND DATA OWNERSHIP RIGHTS; INFRINGEMENT
9.1 OWNERSHIP OF DATA AND TECHNICAL INFORMATION
[...***...]
(B) Inventorship of any inventions acquired or developed in
connection with the development program shall be determined by reference to
United States patent laws pertaining to inventorship. Accordingly, (i) if an
invention is made in connection with the development program by one (1) or more
employees or consultants of each party, it shall be deemed to be a "Joint
Invention". If one or more claims included in an issued Patent or pending patent
application which is filed in a patent office in the Territory claim such Joint
Invention following rules shall govern ownership of such Patent or patent
application: [...***...] (c) any other Joint Inventions shall be jointly owned
by CIMA and ESI as Joint Patent Rights hereunder. If an invention is made in
connection with the development program solely by an employee or consultant of a
party, it shall be solely owned by such party, and any Patent filed claiming
such solely owned invention shall also be solely owned by such party. Each party
shall require its employees and consultants to disclose to it any inventions
relating to the Product in writing promptly after conception, and each party
shall, subsequent to any such disclosures to it by its employees or consultants,
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promptly disclose such inventions to the other party. Each party shall ensure
that its employees and consultants shall assign his/her interest in such
invention(s) to his/her respective party employer, as the case may be, and such
rights shall therefore vest in the respective party employer to whom the
inventor assigns his/her rights. [...***...] The parties shall mutually agree
upon how and where to file and prosecute any Joint Patent Rights, the
maintenance of any ensuing Joint Patent Rights covering such Joint Inventions,
and how to license, enforce, defend and protect any such Joint Patent Rights and
how to share the costs relating thereto.
9.2 INFRINGEMENT
(a) Each party shall promptly report in writing to the other party during
the term of this Agreement any known infringement or suspected infringement of
any of the CIMA Patents in the Territory by manufacture, use or sale of a
Product on a commercial scale in derogation of the rights granted to ESI
hereunder (hereinafter, a "Related Infringement") of which it becomes aware, and
shall provide the other party with all available evidence supporting said
infringement or suspected infringement.
(b) Except as provided in paragraph (d) below, CIMA shall have the right to
initiate an infringement or other appropriate suit anywhere in the Territory
against any Third Party who at any time has infringed, or is suspected of
infringing, any of the CIMA Patents. CIMA shall give ESI sufficient advance
notice of its intent to file any suit on account of a Related Infringement and
the reasons therefor, and shall provide ESI with an opportunity to make
suggestions and comments regarding such suit. CIMA shall keep ESI promptly
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informed, and shall from time to time consult with ESI regarding the status of
any such suit on account of a Related Infringement and shall provide ESI with
copies of all documents filed in, and all written communications relating to,
such suit.
(c) CIMA shall have the sole and exclusive right to select counsel for any
suit referred to in subsection (b) above and shall, except as provided below,
pay all expenses of the suit, including without limitation attorneys' fees and
court costs. ESI, in its sole discretion, may elect, within 60 days after the
commencement of such litigation on account of a Related Infringement, to
contribute to the costs incurred by CIMA in connection with such litigation and,
if it so elects, any damages, royalties, settlement fees or other consideration
received by CIMA as a result of such litigation shall be shared by CIMA and ESI
pro rata based on their respective sharing of the costs of such litigation
provided that such pro rata share shall not exceed fifty percent (50%) unless
CIMA has consented to a higher share in writing. In the event that ESI elects
not to contribute to the costs of such litigation, CIMA shall be entitled to
retain any damages, royalties, settlement fees or other consideration for
infringement resulting therefrom. If necessary, ESI shall join as a party to the
suit but shall be under no obligation to participate except to the extent that
such participation is required as the result of being a named party to the suit.
ESI shall offer reasonable assistance to CIMA therewith at no charge to CIMA
except for reimbursement of reasonable out-of-pocket expenses incurred in
rendering such assistance. ESI shall have the right to participate and be
represented in any such suit by its own counsel at its own expense. CIMA shall
not settle any such suit on terms which grant any license to any other
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party in derogation of the rights granted to ESI hereunder without obtaining the
prior written consent of ESI, which consent shall not be unreasonably withheld.
(d) In the event that CIMA elects not to initiate an infringement or other
appropriate suit pursuant to subsection (b) above on account of a Related
Infringement after reasonable efforts to abate such Related Infringement without
litigation have failed, but in no event later than ninety (90) days after ESI's
notice to CIMA under Section 9.3(a), CIMA shall promptly advise ESI of its
intent not to initiate such a suit, ESI shall have the right, at the expense of
ESI, of initiating an infringement or other appropriate suit against the party
or parties committing such Related Infringement. In exercising its rights
pursuant to this subsection (d), ESI have the sole and exclusive right to select
counsel and shall, except as provided below, pay all expenses of the suit
including without limitation attorneys' fees and court costs. CIMA, in its sole
discretion, may elect, within 60 days after the commencement of such litigation,
to contribute to the costs incurred by ESI in connection with such litigation,
and, if it so elects, any damages royalties, settlement fees or other
consideration received by ESI as a result of such litigation shall be shared by
ESI and CIMA pro rata based on their respective sharing of the costs of such
litigation provided that such pro rata share shall not exceed fifty percent
(50%) unless ESI has consented to a higher share in writing.
In the event that CIMA elects not to contribute to the costs of such
litigation, ESI shall be entitled to retain any damages, royalties, settlement
fees or other consideration for infringement resulting therefrom. If necessary,
CIMA shall join as a party to the suit but shall
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UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
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be under no obligation to participate except to the extent that such
participation is required as a result of being named a party to the suit. At
ESI's request, CIMA shall offer reasonable assistance to ESI in connection
therewith at no charge to ESI except for reimbursement of reasonable
out-of-pocket expenses incurred in rendering such assistance. CIMA shall have
the right to participate and be represented in any such suit by its own counsel
at its own expense.
9.3 CLAIMED INFRINGEMENT
(a) In the event that a Third Party at any time provides written notice of
a claim to, or brings an action, suit or proceeding against, either party or any
of their respective Affiliates, claiming infringement of its patent rights,
[...***...]
(b) If a Third Party at any time brings an action, suit or proceeding
against ESI and/or CIMA and/or their Affiliates, claiming infringement of its
patent rights, [...***...] ESI shall have the right to use counsel of its own
choice and shall control the defense of any such action, suit or proceeding. If
CIMA desires to have additional counsel of its own choice participate in the
defense, CIMA shall be solely responsible for the costs and expenses of its
counsel. ESI shall have the authority to settle any such action, suit or
proceeding with the prior written consent of CIMA, such consent not to be
unreasonably withheld or delayed. If ESI receives any payment(s) as part of the
settlement of any such threatened or actual action, suit or proceeding,
[...***...]
(c) If a Third Party at any time brings an action, suit or proceeding
against ESI and/or its Affiliates, claiming infringement of its patent rights,
based upon an assertion or
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UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
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claim arising out of the use, importation, distribution, [...***...], the
parties shall share equally responsibility for and any and all costs and
expenses associated with such legal actions including, without limitation,
damages, settlement payments, attorneys' fees and court costs. Each party shall
offer reasonable assistance to the other party in connection therewith at no
charge to the other party except for reimbursement of reasonable out-of-pocket
expenses incurred in rendering such assistance.
(d) This Section 9.3 states the entire responsibility of CIMA in the case
of any claimed infringement or violation of any Third Party's patent rights.
ARTICLE X
TERM AND TERMINATION
10.1 TERM This Agreement shall be effective as of the Effective Date, and,
unless sooner terminated by mutual agreement or pursuant to any other provision
of this Agreement, shall continue in full force and effect, on a
country-by-country basis, until the later to occur of (a) ten (10) years from
the Launch Date of Product in such country, or (b) expiration of the last to
expire of the CIMA Patents in each such country (the "Term").
10.2 TERMINATION FOR DEFAULT Each party may terminate this Agreement if the
other party commits a material breach of any material obligation under this
Agreement and fails to remedy such breach within sixty (60) days (or, in the
case of a late payment, ten (10) business days of notice of such breach), or
other longer period of time if mutually agreed; provided that if the defaulting
party initiates steps within the sixty (60) day notice period to
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UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
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remedy or cure the breach, unless the parties mutually agree otherwise, such
termination shall become effective only if the breach is not remedied within one
hundred and twenty (120) days after the initial notice from the non-defaulting
party. For purposes of clarification, unless otherwise mutually agreed by the
parties in writing, (a) in no event shall a defaulting party have longer than
one hundred twenty (120) days to remedy a material breach (other than a material
breach of a payment obligation) under this Section, and (b) in no event shall a
defaulting party have longer than ten (10) business days to remedy a material
breach of a payment obligation under this Section.
10.3 [...***...]
ARTICLE XI
EFFECT OF EXPIRATION AND TERMINATION
11.1 [...***...]
11.2 DEVELOPMENT COMMITMENTS In the event that CIMA terminates this
Agreement pursuant to Section 10.2 or ESI terminates this Agreement pursuant to
Section 10.3, all development commitments (internal and external) of CIMA
incurred or committed up through the effective date of such termination shall
become due and payable to CIMA by ESI on the effective date of such termination.
11.3 [...***...] In the event that no such assignment may legally be made
in any country in the Territory, [...***...]
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UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
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11.4 NO DAMAGES UPON EXPIRATION OR TERMINATION Except as otherwise set
forth in this Agreement, neither party shall be entitled to any compensation
whatsoever as a result of expiration or termination of this Agreement, but
without limiting either party's damages for any breach of this Agreement.
11.5 CONTINUING OBLIGATIONS Termination or expiration of this Agreement for
any reason shall be without prejudice to any obligations which shall have
accrued to the benefit of either party prior to such termination or expiration.
Upon termination or expiration of this Agreement, any payments owed to the other
party on or before the effective date of termination would be due within thirty
(30) days of the effective date of such termination or expiration. The following
provisions of this Agreement shall survive expiration or termination hereof
Article VIII, Section 9.1, Articles XI and XIV.
ARTICLE XII
TRADEMARKS
12.1 [...***...]
12.2 TRADEMARK OWNERSHIP AND USE
a.ESI recognizes CIMA's exclusive ownership of and title in and to the
MARKS, and shall not at any time do or permit to be done any act or thing which
would in any way impair the rights of CIMA in and to the MARKS or in any
trademark registration application therefor, and shall not at any time claim any
right of interest in or to the MARKS or the aforesaid trademark application
therefor.
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UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
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b. ESI agrees that during the term of the Agreement and after its
termination, however occurring, that ESI shall not:
(i) use the MARKS or any other mark confusingly similar thereto
in connection with any goods not covered by this Agreement which would
be likely to cause confusion between the parties; or
(ii) apply for or seek registration anywhere in the world, at any
time, for the MARKS or any other mark confusingly similar thereto; or
(iii) commit or do any act which might prejudice or adversely
affect the validity of the MARKS or CIMA's ownership thereof or dilute
or diminish the value of the MARKS to CIMA.
c. ESI shall use the MARKS only in a proper trademark sense and shall
identify the MARKS as a registered trademark of CIMA by including use of the
registered trademark symbol (R) or the symbol (TM) in association with the MARKS
as specified by CIMA.
d. ESI agrees that all goodwill resulting from its use of the MARKS
shall inure to the exclusive benefit of CIMA.
e. ESI shall assist CIMA in obtaining or maintaining registrations for
the MARKS by supplying specimens, other proofs of use and other information or
documents reasonably necessary to obtain or maintain registration of the MARKS
in all jurisdictions within the Territory.
12.3 [...***...]
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ARTICLE XIII
PRESS RELEASES AND PUBLICATIONS
13.1 PRESS RELEASES The parties agree to issue a joint press release,
in the form attached hereto as Exhibit F, upon the Effective Date. All other
press releases and public announcements related to this Agreement shall be
approved in advance in writing by the other party.
13.2 PUBLICATIONS The parties shall mutually agree upon publications
and the publication strategy with respect to work undertaken by the parties
relating to Product, and neither party shall publish any result or study
generated or developed under this Agreement except upon review by the other
party at least sixty (60) days prior to submission of an abstract or manuscript
for publication.
ARTICLE XIV
MISCELLANEOUS
14.1 FORCE MAJEURE Neither party shall be liable for delay or failure
to perform its obligations hereunder for so long as that failure or delay is the
result of an event beyond its control which it could not have avoided by the
exercise of reasonable diligence, (a force majeure event), provided that such
party uses commercially Reasonable Efforts to comply with the terms of this
Agreement as soon as practicable. A party asserting a force majeure event shall
notify the other party promptly, giving an indication of the likely extent and
duration thereof.
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14.2 ASSIGNMENT; SUCCESSORS AND ASSIGNS Neither party shall at any
time, without obtaining the prior written consent of the other party, assign or
transfer this Agreement to any Person. Notwithstanding the foregoing, each party
shall be permitted to assign this Agreement to its Affiliates or to perform this
Agreement, in whole or in part, through its Affiliates, provided that such party
shall be primarily liable and responsible for performance by such Affiliate
hereunder; and each party may also assign this Agreement to any successor by
merger or upon a sale of all or substantially all of the assets to which this
Agreement relates. This Agreement shall be binding upon and shall inure to the
benefit of the parties and their successors and permitted assigns.
14.3 NOTICES Any notices required or permitted to be given hereunder
shall be in writing and shall be delivered by air courier service (requiring
signature upon receipt) or sent by first class air mail, postage prepaid, or
telefax (confirmed by phone conversation with the recipient) to the addresses
set forth below. The parties may change the address at which notice is to be
given by giving notice to the other party as herein provided. All notices shall
be deemed effective upon receipt by the party to whom it is addressed.
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UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
200.83 AND 240.24B-2
If to CIMA: CIMA LABS, Inc.
10000 Valley View Road
Eden Prairie, Minnesota 55344
Attention: Dr. John Siebert
President and CEO
Telephone: (612) 947-8762
Telefax: (612) 947-8770
If to ESI: ESI Lederle With a copy to:
130 North Radnor-Chester Road American Home Products Corporation
St. Davids, Pennsylvania 19087 5 Giralda Farms
Madison, New Jersey 07940
Attention: President Attention:
Telephone: (610) 971-4550 Senior Vice President & General Counsel
Telefax: (610) 995-3394 Telephone: (973) 660-6040
Telefax: (973) 660-7050
14.4 GOVERNING LAW AND JURISDICTION This Agreement and its execution,
validity and interpretation shall be governed in all respects in accordance with
the laws of the State of Delaware, excluding conflicts of law rules.
14.5 SEVERABILITY In the event that any provision of this Agreement
shall be held to be unenforceable, invalid or in contravention of applicable
law, such provision shall be of no effect, and the parties shall negotiate in
good faith to replace such provision with a provision which effects to the
extent possible the original intent of such provision.
14.6 COMPLETE AGREEMENT; MODIFICATIONS This Agreement, together with
all Exhibits attached hereto, constitutes the entire Agreement between the
parties with respect to the present subject matter, all prior negotiations,
agreements and understandings being
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expressly canceled hereby. This Agreement may be amended only by a written
agreement embodying the full terms of the amendment signed by authorized
representatives of both parties.
14.7 NO AGENCY Neither party shall by virtue of this Agreement have any
power to bind the other to any obligation nor shall this Agreement create any
relationship of agency, partnership or joint venture.
14.8 NO WAIVER No term or condition of this Agreement shall be
considered waived unless reduced to writing and duly executed by an officer of
the waiving party. Any waiver by any party of a breach of any term or condition
of this Agreement will not be considered as a waiver of any subsequent breach of
this Agreement, of that term or condition or any other term or condition hereof.
14.9 COUNTERPARTS This Agreement may be executed in counterparts, each
of which together shall constitute one and the same Agreement.
14.10 [...***...]
14.11 COMPLIANCE ISSUES The parties acknowledge that the export of
technical data, materials or products is subject to the exporting party
receiving the necessary export licenses and that the parties cannot be
responsible for any delays attributable to export controls which are beyond the
reasonable control of either party. The parties agree that regardless of any
disclosure made by the party receiving an export of any ultimate destination of
any technical data, materials or products, the receiving party will not
re-export either directly or indirectly, any technical data, material or
products without first obtaining the
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applicable validated or general license from the United States Department of
Commerce, FDA and/or any other agency or department of the United States
Government as required.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first above written.
CIMA LABS INC. ESI LEDERLE
By: /s/ John M. Siebert By: /s/ Mike Dey
Name: John M Siebert Name: Mike Dey
Title: President and CEO Title: President
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