EXHIBIT 10.2
DEVELOPMENT AND LICENSE AGREEMENT
BETWEEN
CIMA LABS INC.
AND
WYETH
ACTING THROUGH ITS
WYETH CONSUMER HEALTHCARE DIVISION
FOR
NON-PRESCRIPTION RAPID DISSOLVING LORATADINE TABLETS
TABLE OF CONTENTS
ARTICLE I DEFINITIONS........................................................ 1
ARTICLE II GRANT OF RIGHTS; EXCLUSIVITY...................................... 5
ARTICLE III DEVELOPMENT ACTIVITIES........................................... 6
ARTICLE IV DILIGENCE OBLIGATIONS............................................. 7
ARTICLE V ROYALTY PAYMENTS TO CIMA........................................... 8
ARTICLE VI REPRESENTATIONS AND WARRANTIES.................................... 9
ARTICLE VII INDEMNIFICATION.................................................. 11
ARTICLE VIII CONFIDENTIALITY................................................. 12
ARTICLE IX TECHNOLOGY AND DATA OWNERSHIP RIGHTS; INFRINGEMENT................ 14
ARTICLE X TERM AND TERMINATION............................................... 17
ARTICLE XI EFFECT OF EXPIRATION AND TERMINATION.............................. 18
ARTICLE XII TRADEMARKS....................................................... 19
ARTICLE XIII PRESS RELEASES AND PUBLICATIONS................................. 20
ARTICLE XIV MISCELLANEOUS.................................................... 21
EXHIBIT A - CIMA PATENTS
EXHIBIT B - ADVERSE EXPERIENCE REPORTING PROCEDURES
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DEVELOPMENT AND LICENSE AGREEMENT
THIS AGREEMENT dated the 18th day of June 2002 between CIMA LABS INC.,
a corporation organized and existing under the laws of the State of Delaware
with offices located at 00000 Xxxxxx Xxxx Xxxx, Xxxx Xxxxxxx, Xxxxxxxxx 00000
(hereafter, together with its Affiliates, referred to as "CIMA"), and WYETH
(formerly known as American Home Products Corporation), acting through its Wyeth
Consumer Healthcare Division, a corporation organized and existing under the
laws of the State of Delaware with offices located at Five Xxxxxxx Xxxxx,
Xxxxxxx, Xxx Xxxxxx 00000 ("WCH").
W I T N E S S E T H
WHEREAS, CIMA and Wyeth, acting through its ESI Lederle Division
("ESI"), entered into a Development and License Agreement, dated January 14,
2000 (the "Original Development and License Agreement"); and
WHEREAS, CIMA and WCH wish to amend the Original Development and
License Agreement to remove the OTC Field (as defined herein) and to enter into
this Development and License Agreement which relates only to the OTC Field, all
on the terms and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the representations, warranties and
covenants set forth herein, the parties hereto agree as follows:
ARTICLE I
DEFINITIONS
1.1 "ACTIVE INGREDIENT" means ethyl 4-(8-chloro-5,
6-dihydro-11H-benzo [5,6] cyclohepta [1,2-b] pyridin-11-ylid-ene)-1
piperidinecarboxylate, known as loratadine.
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 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 Regulatory Approvals and/or
Pricing Approvals, for the sale of the Product in the OTC Field in a country in
the Territory.
1.5 "ANDA" means an Abbreviated New Drug Application, as defined
in the United States Federal Food, Drug and Cosmetic Act, as amended, and
applicable FDA rules and regulations.
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, the DuraSolv(TM) technology
or the OraSolv(R) technology, 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 effort and resources may change at
different times during the product life cycle of a compound or product.
1.8 "COMPETING PRODUCT" means a rapid dissolving solid dosage form
product containing 10 mg of Active Ingredient as the only active ingredient
(other than the Product) that competes with the Product in the OTC Field in the
Territory.
1.9 "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.
1.10 "EFFECTIVE DATE" means January 14, 2000.
1.11 "FDA" means the United States Food and Drug Administration, or
any successor thereto.
1.12 "FTO STATUS" means that (i) final Regulatory Approval (which
includes without limitation WCH's consumer labeling and packaging) and, if
applicable, Pricing Approval to market the Product have been obtained, (ii) all
legal claims, actions, proceedings and appeals with respect to the Product have
been finally resolved in WCH's and in CIMA'S favor, and (iii) all relevant
patents have expired, been declared invalid or determined by WCH not to be
infringed by the Product.
1.13 "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 Cosmetic 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.
1.14 "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 Cosmetic Act and applicable regulations
promulgated thereunder, as amended from time to time,
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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.
1.15 "GOOD MANUFACTURING PRACTICE" or "GMP" means the then current
standards for the manufacture of pharmaceuticals, as set forth in the United
States Federal Food, Drug and Cosmetic 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.
1.16 "JOINT PATENT RIGHTS" has the meaning set forth in Section
9.1(b).
1.17 "LAUNCH DATE" means the date of first commercial shipment of
the Product in the OTC Field by WCH or its Affiliates or their respective
subdistributors to Third Parties in a country in the Territory.
1.18 "MARKET" means each country (i.e., United States, United
Kingdom, France, etc.) within the Territory that requires Regulatory Approval
for the sale of Product within that country.
1.19 "NDA" means a New Drug Application, as defined in the United
States Federal Food, Drug and Cosmetic Act, as amended, and applicable FDA rules
and regulations.
1.20 "NET SALES" means the gross invoice price for Product sold by
WCH or its Affiliates or sublicensees or subcontractors to a Third Party
customer less the reasonable and customary accrual-basis deductions from such
gross amounts for: (i) normal and customary trade, cash and other discounts,
allowances and credits actually allowed and taken directly with respect to sales
of Product; (ii) credits or allowances actually granted for damaged goods,
returns or rejections of Product; (iii) sales or similar taxes (including duties
or other governmental charges levied on, absorbed or otherwise imposed directly
on the sales of Product, including, without limitation, value added taxes or
other governmental charges otherwise measured by the billing amount) which are
included in billing amount, and excluding any taxes imposed on or measured by
the net income or profits of the selling party; (iv) uncollectable accounts; (v)
charge back payments and rebates granted to managed health care organizations or
to federal, state and local governments, their agencies and purchasers and
reimbursers or to trade customers, including but not limited to, wholesalers and
chain and pharmacy buying groups; and (vi) rebates (or equivalents thereof) that
are granted to or charged by national, state, provincial or local governmental
authorities in countries other than the United States. Such amounts shall be
determined from the books and records of WCH, 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 WCH
products. Sales between or among WCH, its Affiliates and its sublicensees and
subdistributors shall be excluded from the computation of Net Sales if such
Affiliates or sublicensees and subdistributors are not end-users, but Net Sales
shall include the subsequent final sales to Third Parties by any such Affiliates
or sublicensees or subdistributors. Where (i)
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Product is sold by WCH, 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 WCH's average Net Sales for the applicable quantity of the Product
at that time.
1.21 "OTC FIELD" means the area of non-prescription (i.e., not
requiring, by law or regulation, a prescription from a medical doctor) and/or
over-the-counter sales for all human pharmaceutical uses.
1.22 "PATENTS" means all patents and patent applications, and all
additions, divisions, continuations, continuations in-part, pipeline protection,
substitutions, reissues, reexamination certificates, extensions, registrations,
patent term extensions, supplementary protection certificates and renewals of
any of the above.
1.23 "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.
1.24 "PRICING APPROVAL" means any approval for price or
reimbursement as may be necessary or appropriate as a prerequisite for marketing
the Product in the OTC Field in a particular country of the Territory.
1.25 "PRODUCT" means rapid dissolving tablets containing 10
milligrams Active Ingredient meeting the Specifications. The Product shall be
pharmaceutically equivalent and bioequivalent to CLARITIN(R) REDITABS containing
10 milligrams Active Ingredient.
1.26 "REGULATORY APPROVAL" means the product license or marketing
approval necessary as a prerequisite for marketing the Product in the OTC Field
in a particular country in the Territory.
1.27 "REGULATORY DOCUMENTS" means all regulatory submissions,
Regulatory Approvals and Pricing Approvals.
1.28 "SPECIFICATIONS" means the specifications for the Product as
set forth in ANDA 75-822 and NDA 21-375, 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
any Agency.
1.29 "SUPPLY AGREEMENT" means the Supply Agreement for the
exclusive supply of Product by CIMA to WCH for the OTC Field between the parties
signed contemporaneously with this Agreement.
1.30 "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,
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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.
1.31 "TERM" has the meaning set forth in Section 10.1.
1.32 "TERRITORY" means the world.
1.33 "THIRD PARTY" means any Person other than a party to this
Agreement or an Affiliate of a party to this Agreement.
1.34 "$" means United States dollars.
ARTICLE II
GRANT OF RIGHTS; EXCLUSIVITY
2.1 GRANT OF RIGHTS. During the Term of this Agreement and
thereafter as provided in Section 11.3(b), CIMA hereby grants to WCH, 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 for the OTC Field within the Territory,
provided that CIMA grants only a non-exclusive license under U.S. Patent No.
5,225,197 and corresponding patents throughout the world. In addition to the
foregoing, WCH shall have an exclusive license under the CIMA Patents and
Technical Information, and CIMA's interest in the Joint Patent Rights, to make
(and to have made) Product for the OTC Field in the Territory subject to, and in
accordance with, the provisions of Section 11.3(b) and the applicable provisions
of the Supply Agreement.
2.2 SUBLICENSE RIGHTS. The rights granted to WCH hereunder include
the right to sublicense all or part of such rights to WCH Affiliates and/or
Third Parties in all or part of the Territory; 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 WCH with
the right and obligation to enforce such terms and conditions; (b) WCH 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 WCH grants a
sublicense to a Third Party, then WCH shall promptly notify CIMA of the identity
of the Third Party; provided, however, that any sublicense of the rights
contained in 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 EXCLUSIVITY. During the Term of this Agreement, with respect
to countries not subject to European Union ("EU") competition law, neither party
shall manufacture, license, distribute or sell any Competing Product for the OTC
Field in the Territory. With respect to countries of the Territory subject to EU
competition law, during the Term of this Agreement, neither party shall
manufacture or distribute any Competing Product for the OTC Field in the
Territory. Notwithstanding anything contained in this Section 2.3, nothing
contained herein shall prevent WCH or any Affiliate of WCH from acquiring an
interest in a business (the "Acquired Business") which is developing, has
developed or is selling any Competing Product for the OTC
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Field in the Territory (the "Competing Operations") where the annual revenues of
the Competing Operations do not exceed twenty percent (20%) of the aggregate
annual revenues of the Acquired Business.
2.4 RIGHT OF FIRST REFUSAL. If during the Term CIMA determines to
develop any other product containing Active Ingredient, CIMA shall notify WCH,
in writing. WCH may elect, by written notice provided to CIMA within sixty (60)
days after receipt of CIMA's notice, to negotiate an agreement with CIMA under
which WCH would obtain exclusive rights to such product for the OTC Field. In
the event WCH elects to negotiate such an agreement, the parties shall use their
Commercially Reasonable Efforts to negotiate, in good faith, such an agreement
within ninety (90) days (or such longer period of time as the parties may
mutually agree upon in writing) after WCH has provided CIMA with such written
notice. If the parties have not signed a definitive agreement prior to the end
of such ninety (90) day period (or such longer period of time as the parties may
mutually agree upon in writing), CIMA shall be free to enter into an agreement
with any third party with respect to such product.
ARTICLE III
DEVELOPMENT ACTIVITIES
3.1 DEVELOPMENT AND REGISTRATION RESPONSIBILITIES FOR THE PRODUCT.
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 (c) conduct scale-up activities for the manufacture
and registration of Product in the United States. WCH shall be responsible for
and shall file, own and maintain all submissions for Regulatory Approval and
Regulatory Approvals of Product for the OTC Field in the United States. CIMA
shall be responsible for providing the CMC and related technical components of
such submissions for registration within the United States, as jointly
determined by the parties, and WCH shall be responsible for formatting such
documentation for, and submitting such documentation to, the appropriate
Agencies in the United States. The applications for Regulatory Approval 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 filings for Product for the OTC Field in the United States. WCH,
however, shall be responsible for all communications with the FDA and
post-Regulatory Approval regulatory requirements for Product for the OTC Field
in the United States, including pharmacovigilance and Adverse Drug Experience
reporting, unless otherwise agreed in advance in writing by the parties.
3.2 FUNDING OF PRODUCT DEVELOPMENT. WCH shall pay to CIMA, within
thirty (30) days of receipt of CIMA's invoice, development costs on successful
completion of the development activities for the Product agreed to be performed
by the parties and in amounts not to exceed the budgeted amounts agreed to by
the parties therefor. It is understood that any development activities for which
CIMA has been reimbursed by WCH and/or ESI prior to June 18, 2002 shall not be
subsequently invoiced to WCH hereunder.
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3.3 APPROVAL SUPPORT FOR TERRITORIES OUTSIDE THE UNITED STATES.
CIMA shall produce stability batches and validation batches of the Product,
engage in various development activities and perform various tests as reasonably
necessary to support WCH's registrations outside the United States, including
without limitation being prepared for the pre-approval inspections by
appropriate regulatory authorities and performing the other activities in
support of such registrations. WCH shall compensate CIMA for such activities
based on CIMA's usual and customary charge for such activities.
ARTICLE IV
DILIGENCE OBLIGATIONS
4.1 PERFORMANCE OBLIGATIONS. WCH shall, subject to supply by CIMA
of launch quantities of Product, use Commercially Reasonable Efforts to launch
Product in the United States in the OTC Field within three (3) months following
the Product having FTO Status for the OTC Field in the United States. If CIMA
believes that the Product should be launched outside of the United States, CIMA
agrees to give written notice to WCH of the Market in the OTC Field where CIMA
desires to have the Product launched and WCH will advise CIMA within ninety (90)
days after receipt of such notice whether it desires to launch the Product in
the Market. If WCH gives CIMA notice that it desires to launch a Product in the
OTC Field in a Market, WCH shall, subject to supply by CIMA of launch quantities
of Product, use Commercially Reasonable Efforts to launch Product in such Market
in the OTC Field within five (5) months following the Product having FTO Status
for the OTC Field in such Market. In the event WCH gives CIMA notice that it
does not desire to launch the Product in a Market or fails to launch Product in
the OTC Field in a Market as required by this Section 4.1, CIMA shall have, as
its sole and exclusive remedy, the right upon written notice to WCH to convert
the exclusive licenses granted hereunder with respect to CIMA Patents and
Technical Information in such Market to non-exclusive unless within thirty (30)
days after such written notice WCH launches Product in the OTC Field in such
Market.
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.
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 B
hereto (as may be amended from time to time upon written agreement of the
parties).
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ARTICLE V
ROYALTY PAYMENTS TO CIMA
5.1 ROYALTIES PAYABLE BY WCH.
(a) Following the Launch Date of Product in the OTC Field
in any country in the Territory, WCH shall pay to CIMA, on a quarterly basis, a
royalty of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] on Net Sales of the
Product in the OTC Field during the previous quarter.
(b) WCH shall either (i) pay to CIMA quarterly royalties
on Net Sales of Product sold by any Third Party sublicensee, or (ii) provide in
such sublicense that such sublicensee shall pay to WCH quarterly royalties on
Net Sales of Product sold by such sublicensee, in either case at the royalty
rate set forth in Section 5.1(a), and provided that in either case, WCH shall
remain liable for the timely payment of all such quarterly royalties.
5.2 ROYALTY REPORTS. During the Term of this Agreement following
the Launch Date of Product in any country, WCH shall, within forty-five (45)
days after each calendar quarter for sales of Product in the OTC Field in the
United States and within sixty (60) days after each calendar quarter for sales
of Product in the OTC Field outside the United States, furnish to CIMA a written
quarterly report showing (i) the gross sales of Product in the OTC Field sold by
WCH and its Affiliates and sublicensees during the reporting period and the
calculation of Net Sales from such gross sales; (ii) the royalties and other
payments which shall have accrued hereunder in respect of such sales; (iii)
withholding taxes, if any, required by law to be deducted in respect of such
royalty payments; (iv) the Launch Date(s) of Product in the OTC Field in any
country(ies) during the reporting period; and (v) the exchange rates used in
determining the amount of payment hereunder. Payments accrued in such quarter
shall be paid to CIMA no later than the respective time periods for the United
States (45 days) and other countries (60 days) for submission of royalty reports
after each calendar quarter for sales of Product in a country. In addition, WCH
shall provide CIMA with a non-binding estimate of its annual Net Sales of
Product by quarter ninety (90) days prior to the Launch Date of Product in the
OTC Field. Thereafter, prior to September 30th in any year following the Launch
of Product, WCH shall provide CIMA with non-binding estimates of its annual Net
Sales of Product by quarter for the following year.
5.3 INSPECTION OF RECORDS. The parties shall maintain at their
offices, accurate and complete books and records consistent with sound business
and accounting practices and in such form and in such detail as to enable the
amount of payments payable under this Agreement by the respective party to be
determined. WCH and CIMA shall permit an independent certified accountant
(subject to obligations of confidentiality) appointed by the other party and
reasonably acceptable to WCH 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 WCH'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
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underpayment and such underpayment shall be forthwith paid by such party to the
other party with a penalty at the rate specified in Section 5.5 from the date
such payment was originally due until payment.
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 LATE PAYMENTS. The parties shall pay a penalty on unpaid
amounts overdue by more than thirty (30) calendar days at a rate equal to one
and one-half percent (1.5%) per month for each month a payment is past due. Such
penalty shall not exceed eighteen percent (18%) per year.
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 WCH financial statement exchange
rate applied by WCH on a consistent basis in WCH's own financial accounting on
the date such payment is due, in accordance with U.S. generally accepted
accounting principles, consistently applied.
5.7 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 WCH on behalf of CIMA and shall be paid
to the proper taxing authority. Proof of payment shall be secured, if available,
and sent to CIMA by WCH as evidence of such payment in such form as required by
the tax authorities having jurisdiction over WCH. Such taxes shall be deducted
from the payments that would otherwise be remittable by WCH. WCH shall take
reasonable measures including providing evidence of payment to assist CIMA in
obtaining credit for such taxes against CIMA's United States tax liabilities.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1 REPRESENTATIONS AND WARRANTIES OF EACH PARTY. Each of CIMA and
WCH hereby represents and warrants to the other party hereto as follows:
(a) it is a corporation or entity duly organized and
validly existing under the laws of the state or other
jurisdiction of incorporation or formation;
(b) the execution, delivery and performance of this
Agreement by such party has been duly authorized by
all requisite corporate action and does not require
any shareholder action or approval;
(c) it has the power and authority to execute and deliver
this Agreement and to perform its obligations
hereunder; and
(d) 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
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or constitute a default under (i) a loan agreement,
guaranty, financing agreement, agreement affecting a
product or other 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 WCH 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 Technical Information, with
respect to which WCH has been granted a license or
other rights hereunder in the OTC Field in the
Territory, provided that CIMA has granted, and may in
the future grant, licenses to Third Parties under
such CIMA Patents and Technical Information which
licenses do not conflict with the rights granted to
WCH 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,
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, provided
that CIMA has only a non-exclusive license under U.S.
Patent No. 5,225,197 and its corresponding foreign
counterparts;
(e) to the best of its knowledge the CIMA Patents and
Technical Information do not, as of the Effective
Date, interfere or infringe on any valid intellectual
property rights owned or possessed by any Third Party
in the Territory, provided that whereas WCH is aware
of the possibility of interference between one or
more of the CIMA Patents and United States Patent
5,464,632 (the "632 Patent"), and WCH is aware of
patents corresponding to said 632 Patent in other
jurisdictions, no such representation is made with
respect to said 632 Patent or with respect to any
corresponding patent;
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(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 WCH 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 WCH 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 against the party
which drafted such terms and provisions.
ARTICLE VII
INDEMNIFICATION
7.1 INDEMNIFICATION BY WCH. Except as provided in Section 9.3, WCH
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 and 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 WCH of any
representation, warranty or covenant contained in this Agreement, or (ii) the
manufacture, promotion, distribution, use, testing, marketing, sale or other
disposition of Product by WCH, its Affiliates or sublicensees. Notwithstanding
the foregoing, WCH 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 WCH and its Affiliates, and each
of its and their respective employees, officers, directors and agents (each, an
"WCH Indemnified Party") from and against any Liability which the WCH
Indemnified Party may incur, suffer or be required to pay resulting from or
arising in connection with the breach by CIMA of any representation, warranty or
covenant contained in this Agreement. Notwithstanding the foregoing, CIMA shall
have no
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obligation under this Agreement to indemnify, defend, or hold harmless any WCH
Indemnified Party with respect to claims, demands, costs or judgments which
result from the willful misconduct or negligent acts or omissions of WCH, 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 materially 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
defense or settlement thereof, but in no event shall any such waiver be
construed as a waiver of any rights such party may have 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 or 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. CIMA shall carry in full force and effect product
liability insurance in respect of Product in the amount of One Million Dollars
($1,000,000) per occurrence and in the aggregate and policies of Ten Million
Dollars ($10,000,000) of excess coverage in the aggregate. WCH shall obtain and
carry in full force and effect product liability insurance, or be self insured,
in respect of Product in the amount of One Million Dollars ($1,000,000) per
occurrence and in the aggregate and policies of Ten Million Dollars
($10,000,000) of excess coverage in the aggregate.
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 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
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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; or
(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 WCH 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, WCH may disclose
Confidential Information of CIMA to consultants, to distributors, and to actual
or potential sublicensees 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 disclosure by such
Receiving Party, and the Receiving Party shall be responsible to the Disclosing
Party hereunder.
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ARTICLE IX
TECHNOLOGY AND DATA OWNERSHIP RIGHTS; INFRINGEMENT
9.1 OWNERSHIP OF DATA AND TECHNICAL INFORMATION.
(a) CIMA shall solely own all formulation, system design,
CMC and manufacturing process data and documents that arise out of the
development program ("CIMA Data"), and WCH shall execute such documents and take
such actions as are necessary to implement the foregoing. WCH shall solely own
all clinical data and documents arising from the development program for Product
funded by WCH ("WCH Data"), and CIMA shall execute such documents and take such
actions as are necessary to implement the foregoing. WCH agrees to disclose to
CIMA, on an ongoing basis, in writing, all WCH Data, provided that CIMA shall
not be permitted to use such WCH Data except for internal research purposes, and
further provided that CIMA shall not disclose such WCH Data to any Third Party.
(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, 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, the following rules shall govern ownership of such Patent or patent
application: (i) Joint Inventions which relate specifically to loratadine and/or
administration of loratadine shall be the sole property of WCH; (ii) Joint
Inventions which relate to rapidly-dissolving dosage forms shall be the sole
property of CIMA but shall be included in the CIMA Patents and shall be subject
to the license granted hereunder; and (iii) any other Joint Inventions shall be
jointly owned by CIMA and WCH as joint patent rights hereunder ("Joint Patent
Rights"). 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, 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. CIMA shall use Commercially Reasonable Efforts to obtain and maintain
CIMA Patents for the CIMA DuraSolv(TM) technologies in the United States,
Germany and the United Kingdom. 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, and how to license, enforce, defend and protect any
such Joint Patent Rights and how to share the costs relating thereto.
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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 WCH 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 WCH sufficient
advance notice of its intent to file any suit on account of a Related
Infringement and the reasons therefor, and shall provide WCH with an opportunity
to make suggestions and comments regarding such suit. CIMA shall keep WCH
promptly informed, and shall from time to time consult with WCH regarding the
status of any such suit on account of a Related Infringement and shall provide
WCH 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. WCH, in its sole discretion, may elect, within
sixty (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 WCH 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 WCH 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, WCH
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. WCH 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. WCH 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 party in derogation of the rights granted to WCH hereunder
without obtaining the prior written consent of WCH, 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 xxxxx such Related
Infringement without litigation have failed, but in no event later than ninety
(90) days after WCH's notice to CIMA under Section 9.2(a), CIMA shall promptly
advise WCH of its intent not to initiate such a suit, WCH shall have the right,
at the expense of WCH, 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
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(d), WCH shall 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 sixty (60) days after the commencement of such litigation, to
contribute to the costs incurred by WCH in connection with such litigation, and,
if it so elects, any damages, royalties, settlement fees or other consideration
received by WCH as a result of such litigation shall be shared by WCH 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
WCH has consented to a higher share in writing.
In the event that CIMA elects not to contribute to the costs
of such litigation, WCH 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 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 WCH's request, CIMA
shall offer reasonable assistance to WCH in connection therewith at no charge to
WCH except for reimbursement of reasonable out-of-pocket expenses incurred and a
reasonable allocation of salary and wages based on time spent by CIMA employees
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, based upon an assertion or claim arising out of the filing of an
NDA in the OTC Field by WCH for Product, or the use, manufacture, distribution
or sale of Product in the OTC Field, such party shall promptly notify the other
party of the claim or the commencement of such action, suit or proceeding,
enclosing a copy of the claim and/or all papers served.
(b) If a Third Party at any time brings an action, suit or
proceeding against WCH and/or CIMA and/or their Affiliates, claiming
infringement of its patent rights (i) based upon the filing of an NDA in the OTC
Field by WCH for Product in the Territory or (ii) based on U.S. Patent No.
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] (provided that CIMA has complied with
its obligations under Section 2.8(a) of the Supply Agreement), WCH shall be
responsible for the defense costs and expenses, including attorney's fees
thereof. WCH 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. WCH 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 WCH receives any payment(s) as part of the settlement of any such
threatened or actual action, suit or proceeding, then after deduction of WCH's
costs and expenses, including attorney's fees, the balance (if any) of such
payment(s) shall be split eighty percent (80%) to WCH and twenty percent (20%)
to CIMA.
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(c) Except as expressly provided in Section 9.3(b), if a
Third Party at any time brings an action, suit or proceeding against WCH and/or
its Affiliates, claiming infringement of its patent rights (i) based upon an
assertion or claim arising out of the manufacture of Product or (ii) based on an
assertion that the Product infringes U.S. Patent No. [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] (provided that CIMA failed to comply with its obligations
pursuant to Section 2.8(a) of the Supply Agreement), CIMA shall be responsible
for and indemnify and hold harmless WCH for any and all costs and expenses
associated with such legal actions including, without limitation, damages,
settlement payments, attorneys' fees and court costs. WCH shall offer reasonable
assistant to CIMA 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) Except as expressly provided in Sections 9.3(b) or
9.3(c), if a Third Party at any time brings an action, suit or proceeding
against WCH and/or its Affiliates, claiming infringement of its patent rights,
based upon an assertion or claim arising out of the use, importation,
distribution, offer for sale or sale of Product for the OTC Field in the
Territory, the parties shall share equally responsibility for 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.
(e) This Section 9.3 states the entire responsibility of
the parties to each other 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 after receipt of notice in writing from such party, 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 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, in no event shall a defaulting party have longer than one hundred
twenty (120) days to remedy a material breach under this Section.
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10.3 TERMINATION BY WCH. WCH shall have the right, in its sole
discretion, to terminate this Agreement at any time upon six (6) months' prior
written notice to CIMA.
ARTICLE XI
EFFECT OF EXPIRATION AND TERMINATION
11.1 EXPIRATION. Upon expiration (but not termination) of this
Agreement, WCH shall have the fully paid-up, royalty free, perpetual,
irrevocable, non-exclusive right, itself and/or through its Affiliates, to make,
have made, promote, market, distribute, sell, have sold, import and export
Product for the OTC Field pursuant to the Regulatory Documents and Technical
Information (including manufacturing know-how).
11.2 DEVELOPMENT COMMITMENTS. In the event that CIMA terminates
this Agreement pursuant to Section 10.2 or WCH 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 WCH on the effective date of such
termination.
11.3 TRANSFER OF DOCUMENTS.
(a) In the event that CIMA terminates this Agreement
pursuant to Section 10.2 or WCH terminates this Agreement pursuant to Section
10.3, (i) WCH promptly but no later than within forty-five (45) days of such
termination, shall assign and transfer to CIMA all WCH Data as relates to
Product and (ii) WCH shall, within sixty (60) days of a request by CIMA, execute
all documents necessary to assign to CIMA and/or its Affiliates all Regulatory
Documents in the countries in the Territory where the Agreement has been
terminated which relate to Product for the OTC Field. In the event that no such
assignment may legally be made in any country in the Territory, WCH shall
continue to maintain such Regulatory Documents and provide to CIMA and/or CIMA's
Affiliates and/or their designees continuing access and/or the right to
cross-reference all such Regulatory Documents. Upon CIMA's request, WCH shall
within the same period deliver to CIMA or its designees full copies (both paper
and electronic, where available) of any Regulatory Documents in WCH's or its
Affiliates' possession or control. In such event, CIMA shall pay to WCH
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] of CIMA's gross profit (including
payments to CIMA by the Third Parties) on Product for the OTC Field in the
Territory, payable quarterly with supporting documentation, sold by CIMA or a
Third Party marketing partner up to the total of WCH's out-of-pocket costs for
Product development, consisting of raw materials, biostudy costs, and amounts
paid under Section 3.2 or by ESI pursuant to the Original Development and
License Agreement for product development costs.
(b) In the event that WCH terminates this Agreement
pursuant to Section 10.2, CIMA shall grant to WCH the exclusive right to, and
shall use Commercially Reasonable Efforts to transfer to WCH, the CIMA Data and
manufacturing know-how used by CIMA that is reasonably necessary to enable WCH
to develop and register Product in the OTC Field in the Territory, and to enable
WCH either itself or through a contract manufacturer to manufacture
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Product. WCH shall pay CIMA, on a country-by-country basis, a royalty on Product
for the OTC Field sold by WCH thereafter equal to [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] of WCH's Net Sales during the Term.
(c) After the Term WCH shall have a fully paid-up,
irrevocable, non-exclusive right in the Territory to use the data and documents
and other Technical Information arising out of the development program for
Product in the OTC Field that are owned by CIMA (including any and all Technical
Information relating primarily to the manufacture of the Product, including all
manufacturing know-how) and CIMA shall use Commercially Reasonable Efforts to
transfer to WCH the manufacturing know-how that is reasonably necessary to
enable WCH to make and have made Product for the OTC Field.
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 shall 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 VII, VIII, Section 9.1, Section 9.3, Articles XI and
XIV.
ARTICLE XII
TRADEMARKS
12.1 USE OF CIMA'S TRADEMARK BY WCH. WCH shall market the Product
in the OTC Field under its own tradename. However, WCH may refer to CIMA's
DuraSolv(TM) trademarks (the "Marks") as applicable on the package, internal
leaflet and promotional material of the Product by printing "Produced with CIMA
DuraSolv(TM) technology" or word DuraSolv(TM). For this purpose CIMA grants to
WCH and its Affiliates a non-exclusive license to use CIMA's DuraSolv(TM)
trademarks during the Term. Prior to printing, WCH (or an Affiliate) shall send
CIMA a sample of the packaging, internal leaflet and related promotional
material for CIMA's prior approval of WCH's use of the Marks.
12.2 TRADEMARK OWNERSHIP AND USE.
(a) WCH 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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(b) WCH agrees that during the term of the Agreement and
after its termination, however occurring, that WCH shall not:
(i) use the Marks or any other xxxx 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
xxxx 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) WCH 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) WCH agrees that all goodwill resulting from its use of
the Marks shall inure to the exclusive benefit of CIMA.
(e) WCH 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 QUALITY CONTROL. WCH agrees that, to the extent the Product
is manufactured by a party other than CIMA pursuant to this Agreement, the
Product shall be manufactured in accordance with the Specifications. CIMA shall
have the right to inspect the Products sold in connection with the Marks so that
CIMA can determine that the Products meet the Specifications. If the quality of
any Products is determined not to meet the Specifications, then WCH shall not
use any of the Marks in connection with such Products and WCH shall, at its
option, either (i) destroy such Products or (ii) repackage such Products to
eliminate use of the Marks.
ARTICLE XIII
PRESS RELEASES AND PUBLICATIONS
13.1 PRESS RELEASES. All 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.
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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.
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 or
business 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 in the English language 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.
If to CIMA:
CIMA LABS, Inc.
00000 Xxxxxx Xxxx Xxxx
Xxxx Xxxxxxx, Xxxxxxxxx 00000
Attention: President and CEO
Telephone: 000-000-0000
Telefax: 000-000-0000
If to WCH:
Wyeth Consumer Healthcare
Five Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
Attention: President
Telephone: 000-000-0000
Telefax: 000-000-0000
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With a copy to:
Wyeth
0 Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
Attention: General Counsel
Telephone: 000-000-0000
Telefax: 000-000-0000
14.4 GOVERNING LAW. This Agreement and its execution, validity and
interpretation shall be governed in all respects in accordance with the laws of
the State of New York, 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 the Supply Agreement and all Exhibits attached hereto and thereto,
constitutes the entire agreement between the parties with respect to the present
subject matter, all prior negotiations, agreements and understandings being
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 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 applicable validated or general license
from the
-22-
United States Department of Commerce, FDA and/or any other agency or department
of the United States Government as required.
14.11 AMENDMENT OF THE ORIGINAL DEVELOPMENT AND LICENSE AGREEMENT.
The parties agree that, with effect from the Effective Date, the Original
Development and License Agreement is hereby amended to exclude the OTC Field
from its scope and that this Agreement and the Supply Agreement constitutes the
entire agreement between the parties with respect to the subject matter hereof
and thereof for the OTC Field.
-23-
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first above written.
CIMA LABS INC.
By: /s/ Xxxx Xxxxx
-----------------------------------------
Name: Xxxx Xxxxx
Title: Chief Operating Officer
WYETH,
acting through its Wyeth Consumer Healthcare Division
By: /s/ Xxxxxxx X. Xxxxxxx
------------------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Vice President, Global Business Development
-24-
EXHIBIT A
CIMA PATENTS
1. United States Patent No. 5,178,878
2. United States Patent No. 5,225,197
3. United States Patent No. 6,024,981
4. All foreign counterparts to the above listed patents and patent
applications
EXHIBIT B
ADVERSE EXPERIENCE REPORTING PROCEDURES
The parties hereby agree that the following terms will govern
disclosures of each party to the other with respect to adverse event reporting
relating to Product as clinically tested or marketed by or on behalf of either
party.
1. DEFINITIONS.
1.1 ADVERSE EXPERIENCE OR EVENT (AE): An AE is defined by WCH as
any untoward, undesired, or unplanned event in the form of
signs, symptoms, disease, or laboratory or physiological
observations occurring in a human being in a temporal
relationship to use of an WCH product regardless of causal
relationship. This includes:
- any clinically significant worsening of a pre-existing
condition;
- an AE occurring from overdose (i.e., a dose higher than
that prescribed by a health care professional for clinical
reasons) of an WCH product, whether accidental or
intentional;
- an AE occurring from abuse (i.e., use for non-clinical
reasons) of an WCH product;
- an AE that has been associated with the discontinuation of
the use of an WCH product;
- any failure of expected pharmacological action (for
spontaneous reports).
If there is any doubt whether the information constitutes an
AE, the information will be treated as an AE.
1.2 SERIOUS AE: A serious AE is defined by WCH as an AE occurring
at any dose that: results in death; is life-threatening (see
below); requires inpatient hospitalization or prolongation of
an existing hospitalization; results in a persistent or
significant disability or incapacity (see below); results in
cancer; results in a congenital anomaly or birth defect.
Additionally, IMPORTANT MEDICAL EVENTS that may not result in
death, be life-threatening, or require hospitalization may be
considered a serious AE when, based upon appropriate medical
judgment, they may jeopardize the patient or subject and may
require medical or surgical intervention to prevent one of the
outcomes listed in this definition. Examples of such medical
events include allergic bronchospasm requiring intensive
treatment in an emergency room or at home; blood dyscrasias or
convulsions that do not result in hospitalization; or the
development of drug dependency or abuse.
1.2.1 Life-threatening refers to immediate risk of death as
the event occurred. A life-threatening experience
does not include an experience that, had it occurred
in a more severe form, might have caused death but as
it actually occurred did not create an immediate risk
of death. For example, hepatitis that resolved
without evidence of hepatic failure would not be
considered life-threatening even though hepatitis of
a more severe nature can be fatal. Similarly, an
allergic reaction resulting in angioedema of the face
would not be life-threatening, even though angioedema
of the larynx, allergic bronchospasm, or anaphylaxis
can be fatal.
1.2.2 Disability is defined as a substantial disruption in
a person's ability to conduct normal life functions.
1.2.3 For studies, all pregnancies and all overdoses will
be reported to GSSE in the same time frame as serious
AEs.
1.2.4 A serious AE obtained from tests in laboratory
animals includes any experience suggesting a
significant risk for human subjects, including any
findings of mutagenicity, teratogenicity, or
carcinogenicity.
1.2.5 If there is any doubt whether the information
constitutes a serious AE, the information will be
treated as a serious AE.
1.3 NON-SERIOUS AE: is any AE which does not meet the criteria for
a serious AE.
1.4 UNEXPECTED AE: An unexpected AE is one that is not listed in
the current product labeling. The current product labeling is
either the package insert (for marketed WCH products) or the
current investigator's brochure (for investigational WCH
products).
An unexpected AE includes any event that may be
symptomatically and pathophysiologically related to an event
listed in the labeling, but differs from the labeled event
because of greater severity or specificity. For example,
hepatic necrosis would be unexpected (by virtue of greater
severity) if the product labeling referred only to elevated
hepatic enzymes or hepatitis. Similarly, cerebral
thromboembolism and cerebral vasculitis would be unexpected
(by virtue of greater specificity) if the labeling only listed
cerebral vascular accidents.
1.5 PRODUCT (DRUG, VACCINE, BIOLOGICAL, DEVICE)-RELATED: For the
purposes of regulatory reporting for investigational products,
an AE will be considered "product-related" (i.e.,
drug-related, vaccine-related, etc.) for studies if either the
investigator, the Medical Monitor, the CR&D Clinical Project
Team Medical Monitor (or designee), or the Local Monitor (if
applicable) assesses the AE(s) as possibly, probably, or
definitely related.
-B-2-
1. An AE will be considered "not product-related" for
studies if the investigator AND the medical
monitor(s) AND the local monitor (if applicable)
assess the AE(s) as probably not related or
definitely not related, or "relationship remote."
2. Whenever the investigator's or monitor's assessment
is unknown or unclear, the AE(s) will be treated as
product-related for the purposes of reporting to
regulatory authorities.
1.6 PROTOCOL-RELATED: AEs from studies that are not
product-related may nevertheless be considered by the
investigator OR the medical monitor(s) OR the local monitor
(if applicable) to be protocol-related. For purposes of
reporting to GSSE and regulatory authorities, these will be
reported in the same manner as product-related events.
1.7 ANDA HOLDER is defined as: An "Applicant" for regulatory
approval of a Product in any regulatory jurisdiction,
including a holder of a foreign equivalent thereto.
1.8 Capitalized terms not defined in this Exhibit shall have the
meaning assigned thereto in the Agreement.
2. With respect to the Product or Active Ingredient, the Parties agree as
follows:
a. All initial reports and any follow-up information (oral or
written) for any and all Serious AEs as defined above, (other
than with respect to animal studies) which become known to
either party (other than from disclosure by or on behalf of
the other party) must be communicated by telephone, telefax or
electronically directly to the other party and/or the ANDA
Holder, ("Holder") within forty-eight (48) hours of receipt of
the information. Written confirmation of the Serious AE
received by such party should be sent to the other party
and/or the Holder as soon as it becomes available, but in any
event within forty-eight (48) hours of initial report of the
Serious AE by such party.
b. Both parties shall exchange Medwatch and/or CIOMs forms and
other health authority reports within forty-eight (48) hours
of submission to any Regulatory Authority.
c. All initial reports and follow-up information received for all
Non-Serious AEs for marketed Product which become known to a
party (other than from disclosure by or on behalf of the other
party) must be communicated in writing, by telefax or
electronically to the other party within ten (10) days, on
Medwatch or CIOMs forms (where possible).
d. Each party shall coordinate and cooperate with the other
whenever practicable to prepare a single written report
regarding all Serious and/or Non-Serious AEs,
-B-3-
provided, however, that neither party shall be obligated to
delay reporting of any AE in violation of applicable law or
regulations regarding the reporting of AEs.
3. The parties further agree that:
a. A written report be forwarded to the other party within
forty-eight (48) hours of a receipt by the party making the
report, for AEs for animal studies which suggest a potential
significant risk for humans;
b. Each party will give the other party a report via a print-out
or computer disk of all AEs reported to it and its Affiliates
relating to the Product or Active Ingredient within the last
year, within thirty (30) days of receipt of a request from the
other party but not more often than four (4) times a year;
c. If either party wishes access to AE Reports of the other party
relating to the Product or Active Ingredient, upon request of
that party, the other party shall make available its AE
records relating to the Product or Active Ingredient
(including computer disks) for viewing and copying by the
other party. The parties may discuss the transfer of AE
Reports by computer disk.
d. Disclosure of information hereunder by a party to the other
party shall continue as long as either party and/or its
Affiliates or designees continue to clinically test or market
Product or Active Ingredient.
4. Each party shall diligently undertake the following further obligations
where both parties are or will be performing clinical trials with
respect to the Product or Active Ingredient:
a. Upon the Effective Date, each party shall identify individuals
who shall be responsible for identifying all AE reporting
requirements in all countries of the Territory as set forth in
the Agreement, and any amendments thereto;
b. To immediately consult with the other party, with respect to
the investigation and handling of any serious AE disclosed to
it by the other party or by a Third Party and to allow the
other party to review the Serious AE and to participate in the
follow-up investigation;
c. To immediately advise the other party of any Product and/or
Active Ingredient safety communication received from a health
authority and consult with the other party with respect to any
Product and/or Active Ingredient warning, labeling change or
change to an investigators' brochure involving safety issues
proposed by the other party, including, but not limited to the
safety issues agreed to by the parties;
d. To diligently handle in a timely manner the follow-up
investigation and resolution of each AE reported to it;
-B-4-
e. To provide the other party mutually agreed upon audit rights
of its AE reporting system and documentation, upon prior
notice, during normal business hours, at the expense of the
auditing party and under the confidentiality obligations set
forth in the Agreement;
f. To meet in a timely fashion from time to time as may be
reasonably required to implement the adverse event reporting
and consultation procedures described in this Exhibit B,
including identification of those individuals in each party's
Drug Safety group who will be responsible for reporting to and
receiving AE information from the other party, and the
development of a written standard operating procedure with
respect to adverse event reporting responsibilities, including
reporting responsibilities to investigators;
g. Where possible, to transmit all data electronically;
h. To report to each other any addenda, revisions or changes to
the Agreement (e.g., change in territories, local regulations,
addition of new licensors/licensees to the Agreement, etc.)
which might alter the adverse event reporting responsibilities
hereunder;
i. To utilize English as the language of communication and data
exchange between the parties;
j. To develop a system of exchange of documents and information
in the event that the Agreement involves more than two
parties;
k. To work together to develop an electronic system to transmit
AE data.
5. The parties may meet after the Effective Date of the Agreement to
establish a separate agreement for adverse event exchange which will
supersede this Exhibit B.
-B-5-
