DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT dated as of June 18, 2002 between WYETH acting through its Wyeth Consumer Healthcare Division and IMPAX LABORATORIES, INC. for Loratadine/Pseudoephedrine Combination Tablets
EXHIBIT 10.14
XXXXX INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED.
ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
dated as of June 18, 2002
between
WYETH
acting through its Wyeth Consumer Healthcare Division
and
IMPAX LABORATORIES, INC.
for
Loratadine/Pseudoephedrine Combination Tablets
TABLE OF CONTENTS
ARTICLE I DEFINITIONS |
1 | |||
ARTICLE II GRANT OF RIGHTS; EXCLUSIVITY |
7 | |||
ARTICLE III DEVELOPMENT ACTIVITIES AND PATENT LITIGATION |
9 | |||
ARTICLE IV SUPPLY |
13 | |||
ARTICLE V COMPLIANCE, QUALITY AND ENVIRONMENTAL |
14 | |||
ARTICLE VI LICENSE PAYMENTS, ROYALTIES, AND SUPPLY PRICE |
18 | |||
ARTICLE VII REPRESENTATIONS AND WARRANTIES |
22 | |||
ARTICLE VIII INDEMNIFICATION AND INSURANCE |
25 | |||
ARTICLE IX TERM AND TERMINATION |
27 | |||
ARTICLE X CONFIDENTIALITY |
33 | |||
ARTICLE XI TRADEMARKS; INFRINGEMENT OF IMPAX PATENTS |
35 | |||
ARTICLE XII FORCE MAJEURE |
36 | |||
ARTICLE XIII NOTICES |
37 | |||
ARTICLE XIV MISCELLANEOUS |
38 | |||
EXHIBIT A |
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Impax Patents |
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EXHIBIT B |
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Pricing and Direct Manufacturing Costs |
||||
EXHIBIT C |
||||
Quality Agreement |
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EXHIBIT D |
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Adverse Experience Reporting Procedures |
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THIS DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT is made and entered into as of this
1st day of June 2002, between WYETH, a corporation organized and existing under the laws
of Delaware, acting through its Wyeth Consumer Healthcare Division and having an address at Five
▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ (“WCH”) and IMPAX LABORATORIES, INC., a corporation
organized and existing under the laws of Delaware and having an address at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (“IMPAX”).
RECITALS
WHEREAS, IMPAX has developed two loratadine/pseudoephedrine combination products and has filed
an Abbreviated New Drug Application for each such product with the United States Food and Drug
Administration;
WHEREAS, WCH wishes to license IMPAX’s patents and technical information with respect to such
loratadine/pseudoephedrine combination products and to have IMPAX supply WCH with such products for
sale as over-the-counter drugs; and
WHEREAS, IMPAX is experienced in the manufacture of pharmaceutical products and is willing to
grant such license and supply WCH with such products, all on the terms and subject to the
conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and
for good and valuable consideration the receipt and sufficiency of which are hereby acknowledged,
the parties hereto hereby agree as follows:
ARTICLE I
DEFINITIONS
DEFINITIONS
1.1 Definitions. As used in this Agreement, the following capitalized terms have the
meanings indicated below:
1.1.1 “Affiliate” means, in the case of either Party, any corporation, joint venture, or other
business entity which directly or indirectly controls, is controlled by, or is under common control
with that Party. “Control,” as used in this Section 1.1.1, means having the power to direct, or
cause the direction of, the management and policies of an entity, whether through ownership of
voting securities, by contract or otherwise. Notwithstanding the foregoing, for purposes of this
Agreement, the term “Affiliate” does not include entities in which a Party or its Affiliates owns a
majority of the ordinary voting power to elect a majority of the board of directors but is
restricted from electing such majority by contract or otherwise, until such time as such
restrictions are no longer in effect.
1.1.2 “ANDA” means an Abbreviated New Drug Application, as defined in the FD&C Act and
applicable FDA rules and regulations.
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1.1.3 “Batch” means a Manufacturing run of Product which yields approximately one million two
hundred thousand (1,200,000) tablets of Product, as the same may be amended from time to time by
the mutual written agreement of the Parties.
1.1.4 “Certificate of Analysis” means the document identifying the results of the Methods of
Analysis for a specific Batch of Product in the form agreed to by the Parties.
1.1.5 “CMC” has the meaning set forth in Section 3.1.1(ii).
1.1.6 “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.
1.1.7 “Competing Product” has the meaning set forth in Section 2.3.
1.1.8 “Confidential Information” means either WCH Confidential Information, IMPAX Confidential
Information or both, as the context requires.
1.1.9 “Contract Year” means the period from the Effective Date through May 31, 2003 and each
consecutive twelve (12) month period thereafter during the Term.
1.1.10 “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.
1.1.11 “Direct Development Cost” means (a) costs directly attributable to an activity (i.e.,
those costs which vary with such activity), including, but not limited to, direct labor and benefit
expenses for such activity and consumable bulk and other materials, as determined in accordance
with United States generally accepted cost accounting practices consistently applied, plus (b)
fixed overhead costs allocable to the activity, including, but not limited to, direct benefit and
labor expenses for technical services and support services, depreciation, maintenance and repairs
and insurance costs associated with such activity, as determined in accordance with United States
generally accepted cost accounting practices consistently applied. In no event shall any costs
included in Direct Manufacturing Costs be included in Direct Development Costs.
1.1.12 “Direct Manufacturing Cost” means (a) costs directly attributable to Manufacturing,
quality assurance and quality control related to a unit of Product on a per tablet basis,
including, but not limited to, direct labor and benefit expenses for Manufacturing, and consumable
bulk and other product materials, as determined in accordance with United States generally accepted
cost accounting practices consistently applied, plus (b) fixed Manufacturing overhead costs
allocable to the Product based on the actual percentage utilization (including start-up
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and shut-down time) of the capacity of the manufacturing facility, including, but not limited to,
direct benefit and labor expenses for technical services and support services, depreciation, maintenance
and repairs and insurance costs associated with such utilization of the manufacturing facility, as determined in accordance with
United States generally accepted cost accounting practices consistently applied. In no event shall
charges for (i) idle capacity or underutilized facilities or (ii) any Direct Development Costs be
included in Direct Manufacturing Costs.
1.1.13 “D-12 Product” means a twelve (12) hour extended release tablet containing 5 mg
Loratadine and 120 mg Pseudoephedrine meeting the Specifications therefor.
1.1.14 “D-24 Product” means a twenty-four (24) hour extended release tablet containing 10 mg
Loratadine and 240 mg Pseudoephedrine meeting the Specifications therefor.
1.1.15 “Effective Date” means the date determined pursuant to Section 14.10.
1.1.16 “Exclusive Territory” means the world, except the countries of China (including Hong
Kong), Taiwan, Singapore, Malaysia, The Philippines, Indonesia, Myanmar, Brunei, Cambodia, Vietnam,
Thailand, Laos and the Semi-Exclusive Territory.
1.1.17 “Facility” means IMPAX’s facilities located at Hayward, California or any other
facility located in the United States approved in writing by WCH for the Manufacture of Product,
such approval not to be unreasonably withheld or delayed.
1.1.18 “FDA” means the United States Food and Drug Administration or any successor entity
thereto.
1.1.19 “FD&C Act” means the Federal Food, Drug and Cosmetic Act, as the same may be amended or
supplemented from time to time.
1.1.20 “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
Product have been obtained, (ii) all legal claims, actions, proceedings and appeals with respect to
a Product, including without limitation the Patent Litigations, have been finally resolved in WCH’s
and in IMPAX’s favor or discontinued, and (iii) all relevant patents have expired, been declared
invalid or determined by WCH not to be infringed by a Product.
1.1.21 “Good Clinical Practice” or “GCP” means the then current standards for clinical trials
for pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated
thereunder, as amended from time to time, and such standards of good clinical practice as are
required by the laws and regulations of the European Union and other Regulatory Authorities in
countries in which Products are intended to be sold, to the extent such standards are not
inconsistent with GCP under the FD&C Act.
1.1.22 “Good Laboratory Practice” or “GLP” means the then current standards for laboratory
activities for pharmaceuticals, as set forth in the FD&C Act and applicable
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regulations promulgated thereunder, as amended from time to time, and such standards of good laboratory practice as are required by the laws and regulations of the European Union and other
Regulatory Authorities in countries in which Products are intended to be sold, to the extent such
standards are not inconsistent with GLP under the FD&C Act.
1.1.23 “Good Manufacturing Practice” or “GMP” means the then current standards for the
manufacture of pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated
thereunder, as amended from time to time, and such standards of good manufacturing practice as are
required by the applicable laws and regulations of the European Union and other Regulatory
Authorities in countries in which Products are intended to be sold, to the extent such standards
are not inconsistent with GMP under the FD&C Act.
1.1.24 “Identity Criteria” means the polymorph identity criteria for Loratadine and Product provided in writing by
WCH to IMPAX, as the same may be amended from time to time by the mutual written agreement of the
Parties.
1.1.25 “Identity Tests” means the infrared spectroscopy, X-ray and other defraction tests
(as analyzed by PLS or other similar analytical technique) provided in writing by WCH to IMPAX, as the same may
be amended from time to time by the mutual written agreement of the Parties.
1.1.26 “IMPAX Confidential Information” means all Technical Information pertaining to IMPAX’s
business or its Manufacturing operations disclosed by IMPAX to WCH hereunder. It is understood and
agreed that nothing in this Agreement shall require IMPAX to disclose to WCH any of Schering
Corporation’s confidential information or any other confidential information or documentation that
pertains solely to Schering Corporation and IMPAX hereby agrees not to disclose any such
information to WCH.
1.1.27 “IMPAX Patents” shall mean those Patents owned or Controlled by IMPAX during the Term
that claim a Product, its manufacture or method of use, including the Patents which are set forth
on Exhibit A hereto.
1.1.28 “Indemnified Party” has the meaning set forth in Section 8.1.3.
1.1.29 “Indemnifying Party” has the meaning set forth in Section 8.1.3.
1.1.30 “Launch” means the date on which Product in the OTC Field is sold by WCH or one of its
Affiliates for the first time to a Third Party for commercial distribution in a particular country
in the Territory.
1.1.31 “Loratadine” means pharmaceutical active ingredient with the following chemical
composition: ethyl 4-(8-chloro-5, 6-dihydro-11H-benzo [5,6] cyclohepta [1,2-b]
pyridin-11-ylid-ene)-1 piperidinecarboxylate.
1.1.32 “Manufacture,” “Manufactured” or “Manufacturing” means all activities involved in the
production of Products to be supplied to WCH or its Affiliates hereunder, including,
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without
limitation, the preparation, formulation, finishing, testing, packaging, storage and labeling of
Products and the handling, storage and disposal of any residues or wastes generated thereby.
1.1.33 “Materials” means all materials, including, without limitation, all raw materials,
ingredients, packaging supplies and labels, required for the Manufacture of Products.
1.1.34 “Methods of Analysis” means the regulatory analytical test methods for the D-12 Product
set forth in ANDA 76-050 and for the D-24 Product set forth in ANDA 75-989, as the same may be
amended from time to time in accordance with the provisions of Section 5.3.
1.1.35 “NDA” means a New Drug Application, as defined in the FD&C Act, and applicable FDA
rules and regulations.
1.1.36 “Net Sales” means the gross invoice price for Product sold by WCH or its Affiliates (or
sublicensees pursuant to Section 2.1.2) 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; (iv) uncollectible 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. Such amounts shall be determined from the books and records of WCH, its Affiliates
and their respective sublicensees pursuant to Section 2.1.2 maintained in accordance with U.S.
generally accepted accounting principles consistently applied. Sales between or among WCH, its
Affiliates and its sublicensees pursuant to Section 2.1.2 shall be excluded from the computation of
Net Sales if such Affiliates or sublicensees are not end-users, but Net Sales shall include the
subsequent final sales to Third Parties by any such Affiliates or sublicensees.
1.1.37 “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.
1.1.38 “Party” means WCH or IMPAX or both, as the context requires.
1.1.39 “Patent Litigations” has the meaning set forth in Section 3.2.
1.1.40 “Patents” means all patents and patent applications, and all additions, divisions,
continuations, continuations in-part, pipeline protection, substitutions, reissues,
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reexamination
certificates, extensions, registrations, patent term extensions, supplementary protection
certificates and renewals of any of the above.
1.1.41 “Person” means any natural person, corporation, general partnership, limited
partnership, proprietorship, other business organization, trust, union, association or governmental
authority.
1.1.42 “PPI Adjustment” has the meaning set forth in Section 6.3.2.
1.1.43 “Pricing Approval” means any approval for price or reimbursement as may be necessary or
appropriate as a prerequisite for marketing any Product in the OTC Field in a particular country of
the Territory.
1.1.44 “Product” means D-12 Product or D-24 Product or both, as the context requires.
1.1.45 “Pseudoephedrine” means the pharmaceutical active ingredient known as pseudoephedrine
sulfate, USP.
1.1.46 “Recall” means any action by any Party to recover title to or possession of Product
sold or shipped to Third Parties or the failure by a Party to sell or ship Product to Third Parties
that would have been subject to recall if it had been sold or shipped.
1.1.47 “Regulatory Approval” means all authorizations by the competent Regulatory Authorities
which are required for the manufacture, marketing, promotion, pricing, sale and use of a Product in
a given country or regulatory jurisdiction in the Territory.
1.1.48 “Regulatory Authority” means any national, supra-national, regional, state or local
regulatory agency, department, bureau, commission, council or other governmental entity involved in
the granting of Regulatory Approval and/or Pricing Approval for Products in a country in the
Territory.
1.1.49 “Regulatory Documents” means all regulatory submissions, correspondence, and written
descriptions and written accounts of conversations, with Regulatory Authorities, Regulatory
Approvals and Pricing Approvals.
1.1.50 “Related Infringement” has the meaning set forth in Section 11.2.1.
1.1.51 “Rolling Forecast” has the meaning set forth in Section 4.2.
1.1.52 “Seizure” means any action by FDA or any other Regulatory Authority to detain or
destroy Product or prevent the release of Product.
1.1.53 “Semi-Exclusive Territory” means the countries of Japan and Korea; “semi-exclusive
license” means that IMPAX may either Manufacture and sell Products for the OTC Field
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in its own
name in each country in the Semi-Exclusive Territory or license one (1) other Person (other that
WCH) in each country of the Semi-Exclusive Territory to make, have made, market, promote, use,
distribute, sell, have sold, import and export Products for the OTC Field.
1.1.54 “Specifications” means the specifications for the D-12 Product set forth in ANDA 76-050
and for the D-24 Product set forth in ANDA 75-989, as the same may be amended from time to time in
accordance with the provisions of Section 5.3.
1.1.55 “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, studies, test data, including
pharmacological, toxicological and clinical test data (including bioequivalence studies), chemistry
manufacturing and control data, analytical and quality control data, manufacturing, patent data or
descriptions relating to any Product, and (b) chemical formulations, compositions of matter,
product samples and assays relating to any Product.
1.1.56 “Term” has the meaning set forth in Section 9.1.
1.1.57 “Territory” shall mean both the Exclusive and Semi-Exclusive Territory.
1.1.58 “Third Party” means any Person other than WCH, IMPAX and their respective Affiliates.
1.1.59 “WCH Confidential Information” means all Technical Information and all information and
data pertaining to WCH’s business or products disclosed by WCH to IMPAX hereunder, including,
without limitation, marketing and sales plans, artwork, formats, logos, drawings, customer lists
and operating procedures and all ordering and sales information.
1.1.60 “$” means United States dollars.
1.2 Construction of Certain Terms and Phrases. Unless the context of this Agreement
otherwise requires, (i) words of any gender include each other gender; (ii) words using the
singular or plural number also include the plural or singular number, respectively; (ii) the terms
“hereof,” “herein,” “hereby” and derivative or similar words refer to this entire Agreement; (iv)
the terms “Article” or “Section” refer to the specified Article or Section of this Agreement; and
(v) Article and Section headings shall not affect the meaning or construction of any provision of
this Agreement.
ARTICLE II
GRANT OF RIGHTS; EXCLUSIVITY
GRANT OF RIGHTS; EXCLUSIVITY
2.1 Grant of License.
2.1.1 IMPAX hereby grants to WCH an exclusive license within the Exclusive Territory and a
semi-exclusive license within the Semi-Exclusive Territory, both with the right to
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grant
sublicenses, under the IMPAX Patents and IMPAX’s Technical Information and Regulatory Documents, to
market, promote, use, distribute, sell, have sold, import and export Products for the OTC Field
during the Term of this Agreement. WCH shall notify IMPAX in writing prior to having the name of
any Third Party on a Product label. Notwithstanding the exclusive license set
forth above, IMPAX shall be permitted to Manufacture and sell the D-12 Product to Schering
Corporation in the United States, its territories and possessions.
2.1.2 IMPAX hereby grants WCH an exclusive license within the Exclusive Territory and a
semi-exclusive license within the Semi-Exclusive Territory, both with the right to grant
sublicenses, under the IMPAX Patents and IMPAX’s Technical Information and Regulatory Documents, to
make and have made Products for the OTC Field during the Term under the circumstances described in
Section 2.2. IMPAX shall provide WCH with a hard copy of IMPAX’s Technical Information, ANDA
76-050, ANDA 75-989 and Regulatory Documents relating to the Products and WCH shall have the right
to file such Technical Information, ANDAs and Regulatory Documents with Regulatory Authorities, and
reference the same in WCH’s applications for Regulatory Approval, as necessary or advisable to
obtain Regulatory Approval of Products. Upon WCH’s request, IMPAX agrees to execute such further
documents requested by WCH evidencing WCH’s rights hereunder. The right to grant sublicenses of
the rights granted under this Section 2.1.2 to Affiliates and Third Parties shall be upon IMPAX’s
prior written consent, which shall not be unreasonably withheld or delayed; provided
however that any sublicensee under this Section 2.1.2 must agree in writing to be bound by
WCH’s obligations under this Agreement including but not limited to Article X and Section 6.2.
Notwithstanding the exclusive license set forth above, IMPAX shall be permitted to grant Schering
Corporation a license under the IMPAX Patents and IMPAX’s Technical Information and Regulatory
Documents to make and have made the D-12 Product in the United States, its territories and
possessions.
2.2 Right to Manufacture. WCH shall have the right to manufacture Products pursuant
to the license set forth in Section 2.1.2 at any time after (i) the fifth anniversary of the Launch
of a Product in the United States by WCH upon six (6) months’ prior written notice to IMPAX or (ii)
IMPAX notifies WCH pursuant to the last sentence of Section 5.3.2 that a change required by the FDA
or other Regulatory Authority creates an unreasonable burden on IMPAX or results in the continuing
compliance by IMPAX with this Agreement uneconomical, so long as WCH is not in breach of this
Agreement as of the date such notice is delivered. In such event, IMPAX shall furnish to WCH or
its designee, on a non-exclusive basis, all Technical Information relating to the Manufacture of
Products, including all manufacturing know-how, that is reasonably necessary to enable WCH to make
and have made Products and provide all technical assistance, at WCH’s cost, reasonably requested by
WCH.
2.3 Exclusivity. During the Term, IMPAX and its Affiliates shall only sell Product
for the OTC Field in the Exclusive Territory to WCH and shall not market, promote, use, distribute,
sell, have sold, import, export, make or have made either a twelve-hour or twenty-four hour,
extended release Loratadine and Pseudoephedrine combination product (other than the Products) which
is, in dosage strength, identical to either Product (a “Competing Product”) to a Third Party for
the OTC Field in the Exclusive Territory. Notwithstanding the foregoing,
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IMPAX shall be permitted (i) to Manufacture and sell D-12 Product to Schering Corporation in the United States, its
territories and possessions; and (ii) to market, promote, use, distribute, sell, have sold, import,
export, make or have made a Competing Product that IMPAX or its Affiliate acquires through an
acquisition, divestiture, merger, joint venture or other business combination, provided
that such Competing Product did not account for more than seventy percent (70%) of the sales of the business
acquired by IMPAX or its Affiliate in such transaction during the twelve (12) month period
immediately preceding the consummation of such transaction.
2.4 Non-Compete. During the Term, neither WCH nor its Affiliates shall market,
promote, use, distribute, sell, have sold, import, export, make or have made a Competing Product
for the OTC Field in the Territory. Notwithstanding the foregoing, WCH and its Affiliates shall be
permitted to market, promote, use, distribute, sell, have sold, import, export, make or have made a
Competing Product acquired by WCH or its Affiliates through an acquisition, divestiture, merger,
joint venture or other business combination, provided that such Competing Product
did not account for more than seventy percent (70%) of the sales of the business acquired by WCH or
its Affiliate in such transaction during the twelve (12) month period immediately preceding the
consummation of such transaction.
2.5 IMPAX Patents. IMPAX shall be responsible, at its cost and expense, for
prosecuting to issuance all patent applications within the IMPAX Patents, for filing and
prosecuting all patent reissues and re-examinations, for applying for and obtaining any available
patent term extensions and supplementary protection certificates, and for paying all maintenance
fees, on a large-entity basis, on all patent applications and patents which constitute IMPAX
Patents under this Agreement.
2.6 Reservation of Rights. All rights under the IMPAX Patents, IMPAX’s Technical
Information, IMPAX Confidential Information and IMPAX’s Regulatory Documents not expressly granted
herein to WCH are reserved to IMPAX.
ARTICLE III
DEVELOPMENT ACTIVITIES AND PATENT LITIGATION
DEVELOPMENT ACTIVITIES AND PATENT LITIGATION
3.1 Development and Registration Responsibilities.
3.1.1 Prior to the Effective Date IMPAX has performed the following development and
registration activities:
| (i) | designed, conducted and met all bioequivalency test requirements for Regulatory Approval by FDA in accordance with FDA guidance documents; | ||
| (ii) | designed and conducted all dosage form, formulation, process, and chemistry manufacturing and control (“CMC”) and related technical studies on Products, including preparation of dosage form CMC |
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| regulatory documents required for FDA review and approval of the Products; and |
| (iii) | FDA acceptance for filing of ANDA No. 76-050 and ANDA No. 75-989 with FDA seeking approval of the D-12 Product and D-24 Product, respectively, as generic prescription drugs and is prepared for FDA’s pre-approved inspection. |
3.1.2 At WCH’s request, IMPAX shall supplement and/or amend ANDA No. 76-050 and ANDA No.
75-989 to include WCH’s consumer labeling and packaging and any other documentation necessary or
advisable to support WCH’s consumer labeling and packaging for the OTC Field for the Products.
IMPAX shall, at its expense, (i) complete the construction, installation, commissioning, IQ, OQ and
PQ of all Facilities and all equipment necessary for Manufacture of Products and (ii) conduct all
scale up and validation activities for FDA approval of Products.
3.1.3 IMPAX shall own and maintain ANDA No. 76-050 and ANDA No. 75-989 and shall use its
Commercially Reasonable Efforts to pursue, and at its expense perform any additional development
activities to obtain, final FDA approval of these ANDAs for the OTC Field. WCH may submit
applications for Regulatory Approval for Products in the Territory as it deems advisable (including
NDAs); provided that WCH shall not be required to make any such submissions for
Regulatory Approval unless it determines to do so in its sole discretion. Except for ANDA No.
76-050 and ANDA No. 75-989, WCH shall file, own and maintain all other submissions for Regulatory
Approval and Pricing Approval of Products for the OTC Field in the Exclusive Territory. IMPAX
shall be responsible for providing the CMC and related technical components of such submissions, as
jointly determined by the Parties. Upon WCH’s request and at WCH’s cost, IMPAX shall use
Commercially Reasonable Efforts to provide additional registration batches (including stability and
analytical testing) and required documentation to support any NDA that WCH may submit in the United
States. WCH shall bear the full cost of any additional studies required for Regulatory Approval of
the Products outside of the United States. To the extent that IMPAX undertakes any additional
development work which is not required for FDA approval of a Product, at WCH’s written request, to
support Regulatory Approval in the Territory outside the United States, WCH shall reimburse IMPAX
for the Direct Development Cost thereof.
3.1.4 The Parties shall cooperate with, and assist, each other in connection with their
activities hereunder including without limitation the protocol for scale up and validation and
addressing regulatory questions, and preparing updates and supplements to regulatory filings for
Product for the OTC Field in the Territory. IMPAX shall be responsible for all communications with
FDA regarding ANDA No. 76-050 and ANDA No. 75-989. WCH shall be responsible for all communications
with the FDA and other Regulatory Authorities regarding applications for Regulatory Approval
submitted by WCH and post-Regulatory Approval regulatory requirements for Product marketed by WCH
for the OTC Field in the Territory, including pharmacovigilance and Adverse Drug Experience
reporting, unless otherwise agreed in advance in writing by the Parties.
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3.1.5 Each Party represents that it has complied and shall comply with all applicable GLP, GCP
and GMP in the conduct of the development activity performed by it for the Products.
3.1.6 Upon WCH’s request, IMPAX shall use Commercially Reasonable Efforts to eliminate animal
derived materials from the Products and WCH shall reimburse IMPAX for the actual costs incurred by
IMPAX (provided that such are approved in writing by WCH prior to being incurred by
IMPAX) in connection therewith.
3.2 Patent Litigations. Schering Corporation (“Schering”) has instituted lawsuits
against IMPAX for patent infringement with respect to the D-12 Product and the D-24 Product. In
Schering Corp. v. IMPAX Laboratories, Inc., Civil Action No. 01-0520 (D.N.J.), Schering has charged
infringement of U.S. Patent 4,659,716 (the “‘716 patent”) with respect to the D-12 Product. In
Schering Corp. v. IMPAX Laboratories, Inc., Civil Action No. 01-0009 (D.N.J.), Schering has charged
infringement of both the ‘716 patent and U.S. Patent 5,314,697 (the “‘697 patent”) with respect to
the D-24 Product (collectively, Civil Action No. 01-0520 (D.N.J.) and Civil Action No. 01-0009
(D.N.J.), are referred to herein as the “Patent Litigations”). Schering has also alleged in both
actions that it may be necessary in the future to expand the actions to include claims for
infringement of U.S. Patent 4,863,931 (the “‘931 patent”). Both of these cases have been
consolidated, for pretrial purposes, with other patent infringement actions that Schering has filed
against other defendants, with this consolidated action identified as Schering Corp. v. Geneva
Pharmaceuticals, Inc., Civil Action Nos. 98-1259 (JAG)(GDH); 99-2237 (JAG)(GDH); 00-0255
(JAG)(GDH); 99-2820 (JAG)(GDH); 00-1439 (JAG)(GDH); 00-1657 (JAG)(GDH); 00-2944 (JAG)(GDH); 01-0009
(JAG)(GDH); 01-0279 (JAG)(GDH); 01-0520 (JAG)(GDH); and 02-0328 (JAG)(GDH). IMPAX agrees to
diligently defend the allegations against it in the Patent Litigations and to use all reasonable
efforts to have the ‘716 and ‘697 patents (and also the ‘931 patent, to the extent any claims are
made in the future of infringement of the ‘931 patent) declared invalid, unenforceable and/or not
infringed by the D-12 Product and D-24 Product, including, but not limited to, by defending all
appeals by Schering, and by filing and diligently prosecuting all reasonable appeals of any ruling
or decision adverse to IMPAX. WCH agrees to reasonably cooperate with IMPAX in the conduct of the
Patent Litigations and other proceedings involving WCH. All liabilities, damages attorneys fees
and other costs and expenses incurred in connection with defending the Patent Litigations
(including any claim of infringement of the ‘931 patent) and defending and prosecuting all related
appeals shall be borne by IMPAX. IMPAX shall keep WCH promptly informed of any material
developments and shall from time to time consult with WCH regarding the status of the Patent
Litigations and shall provide WCH with copies of all documents, not containing Schering’s
confidential information, which are filed in, and all unprivileged written communications relating
to the Patent Litigations. Notwithstanding anything to the contrary in this Agreement but subject
to the next sentence, IMPAX shall have no obligation to supply either Product to WCH prior to the
earlier of (i) a United States District Court decision that claims 1 and 3 of the ‘716 Patent are
either invalid, unenforceable or not infringed by such Product or (ii) October 21, 2004 and IMPAX
shall have no obligation to supply the D-24 Product to WCH prior to the earlier of (i) a United
States District Court decision that the ‘697 Patent is either invalid, unenforceable or not
infringed by
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the D-24 Product or (ii) April 23, 2013, unless after July 25, 2003 WCH provides IMPAX
with an
indemnity agreement acceptable to IMPAX for any damages assessed against IMPAX for infringement of
such Patent prior to the occurrence of the first of such events, such acceptance by IMPAX not to be
unreasonably withheld or delayed. The foregoing shall not relieve IMPAX of its obligation to supply
WCH with Product solely for uses reasonably related to the development and submission of
information under the FD&C Act.
3.3 Joint Defense Agreement. Promptly following the Effective Date, the Parties shall
enter into a joint defense agreement mutually acceptable to both Parties containing customary terms
and conditions for the purpose of, among other things, preserving confidentiality and any
applicable privilege attaching to information and data exchanged by the Parties and pursuant to
this Agreement. IMPAX agrees to provide to WCH pursuant to the joint defense agreement a copy of
the written opinion of IMPAX’s outside counsel, with copies of all documents referenced in said
opinion, regarding the validity or invalidity of Schering Corporation’s U.S. Patent 6,335,347.
3.4 Product Launch. WCH shall not be required to Launch Products in any country
unless it determines, in its sole discretion, to do so. If WCH does not, subject to supply by
IMPAX of launch quantities of such Product pursuant to the forecasts set forth in Section 4.2, use
Commercially Reasonable Efforts to Launch a Product in the OTC Field (i) in the United States
within three (3) months, or (ii) in the another country in the Territory within five (5) months,
following such Product having FTO Status for the OTC Field in such country, then IMPAX, at its
option and as its sole and exclusive remedy, may, upon written notice to WCH, convert the licenses
granted hereunder in such country for such Product under the IMPAX Patents and Technical
Information to non-exclusive licenses (and thereby remove the restrictions placed on IMPAX in
Section 2.3 for such Product in such country) unless within thirty (30) days after such written
notice WCH Launches Product in the OTC Field in such country. Following the Launch of a Product in
any country of the Territory, WCH shall use Commercially Reasonable Efforts to market such Product
in such country; provided that nothing shall require WCH to continue marketing a
Product in a country if WCH determines, in its sole judgment, that such Product may be subject to a
regulatory or other legal action or infringe any intellectual property right of any Third Party in
such country. WCH shall promptly notify IMPAX in writing of such discontinuance. If within thirty
(30) days after receipt of IMPAX’s written request, WCH does not resume marketing such Product in
such country, then IMPAX, at its option and as its sole and exclusive remedy, may, upon written
notice to WCH, convert the licenses granted hereunder in such country for such Product under the
IMPAX Patents and Technical Information to non-exclusive licenses
(and thereby remove the
restrictions placed on IMPAX in Section 2.3 for such Product in such country). If at anytime after
Launch of a Product in a country, IMPAX reasonably believes that WCH is not using Commercially
Reasonable Efforts to market such Product in such country, then IMPAX shall notify WCH and if WCH
does not begin to use Commercially Reasonable Efforts to market such Product within such country
within thirty (30) days after such written notice, then IMPAX, at its option and as its sole and
exclusive remedy, may, upon written notice to WCH, convert the licenses granted hereunder in such
country for such Product under the IMPAX Patents and Technical Information to non-exclusive
licenses
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(and thereby remove the restrictions placed on IMPAX in Section 2.3 for such Product in
such country).
ARTICLE IV
SUPPLY
SUPPLY
4.1 Supply. During the Term, WCH shall order from IMPAX, subject to WCH’s right to
Manufacture Products set forth in Section 2.2, WCH’s requirements of Products for the OTC Field in
the Territory and IMPAX shall Manufacture and deliver Products to WCH, subject to (i) WCH having
complied with its obligation to provide Rolling Forecasts pursuant to Section 4.2 and (ii) IMPAX’s
ability to source active ingredient (provided that IMPAX has used Commercially Reasonable Efforts
to do so) in the event that such ability is impaired by WCH’s refusal to approve, or withdrawal of
approval for, a supplier of active ingredient, in such quantities, in such packaging and at such
times as ordered by WCH. IMPAX shall maintain the resources necessary to Manufacture Products at
the Facility and shall provide, at its own expense, all equipment, Materials and labor necessary to
do so. If IMPAX’s Manufacturing obligations for all products that use the same equipment and
resources at the Facility as the Products exceed eighty five percent (85%) of its total capacity
for such equipment and resources at the Facility for more than thirty (30) consecutive days, IMPAX
shall notify WCH in writing and, upon WCH’s request, IMPAX shall use Commercially Reasonable
Efforts to increase its Manufacturing capacity at the Facility to maintain a better that eighty
five percent (85%) ratio. If any batch of Loratadine or Product fails to meet the Identity
Criteria based on the Identity Testing performed pursuant to Section 5.2, the Parties shall be
relieved of their respective obligations to supply and accept delivery of Product relating to said
failed batch.
4.2. Forecasts. At least four and one-half (41/2) months prior to the anticipated
Launch date (provided that the anticipated Launch date shall be at least four and
one-half (41/2) months after the date on which WCH provides IMPAX with the Identity Criteria or
notifies IMPAX in writing that none are required) in each country of the Territory, WCH shall
submit to IMPAX a forecast of the quantity of Product that WCH anticipates ordering from IMPAX for
such country during the twelve (12) month period (broken down by Product and by month) following
Launch and every month thereafter at least three (3) months prior to the beginning of the period
covered by the forecast WCH shall update such forecast on a rolling twelve (12) months basis (each,
a “Rolling Forecast”). WCH shall place purchase orders pursuant to Section 4.3 for at least the
quantity of Product specified in the first three (3) months of each such Rolling Forecast and the
remaining nine (9) months shall be a non-binding estimate prepared by WCH using Commercially
Reasonable Efforts. Except as set forth in the immediately preceding sentence, WCH shall not be
required to order any fixed minimum quantity of Product, notwithstanding any forecast or prior
course of dealing. If WCH fails to give IMPAX Rolling Forecasts as specified above after notice by
IMPAX of such failure the prior three (3) months Rolling Forecast shall apply. IMPAX shall use
Commercially Reasonable Efforts to allocate capacity at the Facility to WCH so that it can supply
WCH with three million (3,000,000) tablets of D-12 Product per calendar month and
one million five hundred thousand (1,500,000) tablets of the D-24 Product per
calendar month.
4.3 Orders and Delivery. WCH shall place its firm orders for Products with IMPAX by
submitting a purchase order which sets forth (i) the quantity of Product ordered for delivery; and
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(ii) the delivery date for that order. Unless IMPAX notifies WCH in writing within fifteen (15)
days of receipt of a purchase order that it is unable to deliver Products in accordance with such
purchase order, IMPAX shall be deemed to have accepted such purchase order as a binding order. If
IMPAX notifies WCH that it is unable to fill such purchase order, it shall indicate the portion of
such purchase order IMPAX cannot supply by the requested delivery date and specify alternate
delivery dates. WCH may cancel any firm purchase order (in whole or in part) at any time prior to
the delivery for any quantity of Product; provided that, except in the event that
this Agreement is being terminated by WCH pursuant to Section 9.2, 9.3.3 or 9.3.4 or by IMPAX
pursuant to Section 5.3.2 or 9.2.3, (i) if IMPAX has completed the Manufacture of Products pursuant
to such firm purchase order, WCH shall pay the price therefor and (ii) if IMPAX has commenced but
not completed the Manufacture of Product pursuant to such firm purchase order, WCH shall reimburse
IMPAX for Material and labor costs in respect of any works-in-progress or Materials orders pursuant
to such cancelled purchase order (or part thereof) at the time notice of cancellation is received
by IMPAX. All Products shall be delivered F.O.B. the Facility in accordance with WCH’s
instructions. Time is of the essence for all deliveries of Products.
4.4 Manufacturing Date. IMPAX shall schedule its Manufacturing operations so that all
Products delivered have the maximum shelf life reasonably possible and in any event no Product
delivered hereunder shall have less than expiry less two (2) months of shelf life (unless a longer
period of time is agreed to by the Parties), based on the dating included on such Products’
packaging, remaining at the time of delivery.
4.5 Inconsistent Terms and Conditions. The terms and conditions of any invoice,
acknowledgement or similar document provided by IMPAX for Products, or any terms and conditions of
purchase orders provided by WCH for Products, which are inconsistent with or in addition to the
terms of this Agreement, shall be null and void.
ARTICLE V
COMPLIANCE, QUALITY AND ENVIRONMENTAL
COMPLIANCE, QUALITY AND ENVIRONMENTAL
5.1 Compliance with Law. IMPAX and, if WCH is Manufacturing Product pursuant to
Section 2.2, WCH shall conduct its Manufacturing operations hereunder in a safe and prudent manner,
in compliance with all applicable laws and regulations (including, but not limited to, those
dealing with occupational safety and health, those dealing with public safety and health, those
dealing with protecting the environment, and those dealing with disposal of wastes), and in
compliance with all applicable provisions of this Agreement. IMPAX and, if WCH is Manufacturing
Product pursuant to Section 2.2, WCH shall obtain all necessary registrations and permits
pertaining to activities contemplated by this Agreement. To the extent necessary for the
Regulatory Approval of Products, IMPAX and, if WCH is Manufacturing Product pursuant to Section
2.2, WCH shall permit the inspection of its premises by Regulatory Authorities and shall supply all
documentation and information to obtain or maintain Regulatory Approval of Products.
5.2 Manufacturing Quality. IMPAX shall obtain all Materials from WCH approved
suppliers. All Products shall be Manufactured at the Facility and in accordance with GMPs. IMPAX
shall sample and analyze all Materials upon receipt to ensure that such Materials are
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free of
defects and meet the applicable specifications therefor. Until WCH notifies IMPAX in writing that
such practice may be suspended or discontinued, IMPAX shall provide samples from each
batch of Loratadine to be used in the Manufacture of any Product and samples from each Batch of
Product to SSCI, Inc. (or such other contract laboratory specified by WCH) to perform the Identity
Testing to ensure that such Loratadine and Product, as the case may be, meet the Identity Criteria.
IMPAX shall promptly provide WCH with the results of such Identity Tests. SSCI, Inc. (or such other
laboratory specified by WCH) shall ▇▇▇▇ WCH directly for such services, and such amounts shall not
be included in Direct Manufacturing Cost. IMPAX shall not use any Loratadine in the Manufacture of
Product that does not meet the Identity Criteria and shall not ship any Product to WCH that does
not meet the Identity Criteria. IMPAX shall take all necessary steps to prevent contamination and
cross contamination of Products. Products shall be unadulterated (within the meaning of the FD&C
Act) and free from contamination, diluents and foreign matter in any amount. IMPAX shall perform
the quality control tests with respect to Products in accordance with the Methods of Analysis, the
cost of the same to be included in the price hereinafter specified. IMPAX shall promptly, upon
completion of such tests, deliver to WCH a copy of the record of such tests performed on, and a
Certificate of Analysis for, each Batch of Product. At WCH’s request, IMPAX shall deliver a
representative sample (in the same amount as the sample that IMPAX retains for its own purposes)
from each Batch of Product to WCH’s designated representative. On the Effective Date or promptly
thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially
in the form of Exhibit C. Each Party agrees to perform its respective obligations under
the Quality Agreement in accordance with such agreement.
5.3 Manufacturing Changes.
5.3.1 IMPAX shall not make any changes to the Manufacturing process, the Manufacturing
equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis
without the prior written consent of WCH, which consent shall not be unreasonably withheld. If
either Party requests in writing a change in the Manufacturing process, the Manufacturing
equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with
respect to any Product that is not the result of a requirement of FDA or any other Regulatory
Authority, the other Party shall use Commercially Reasonable Efforts to make or accept such change,
as the case may be. The requesting Party shall provide the other Party with a detailed written
report of all proposed changes to the Manufacturing process, the Manufacturing equipment, the
Specifications, the Materials, the sources of Materials or the Methods of Analysis.
5.3.2 If FDA or any other Regulatory Authority requests or requires any change in the
Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source
of Materials or Methods of Analysis with respect to any Product the Parties shall meet and discuss
an implementation plan for such change and use all Commercially Reasonable Efforts to accommodate
such change to meet the FDA’s or such other Regulatory Authority’s requirements. Each Party will
bear its respective costs associated with, or incurred as a result of, such change. Each Party
agrees to promptly forward to the other copies of any written communication received by such Party
from the FDA or any other Regulatory Authority that
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may affect the Manufacture or supply of any
Product as contemplated herein. Notwithstanding the foregoing, if after Launch of the D-12 Product
IMPAX determines, in the exercise of its
reasonable judgment, that a change required by the FDA or other Regulatory Authority creates an
unreasonable burden on IMPAX or results in the continuing compliance by IMPAX with this Agreement
uneconomical and if, upon IMPAX’s request, WCH does not agree (i) to pay the incremental cost of
complying with the changes required by FDA or such other Regulatory Authority (which costs shall
not be included in Direct Manufacturing Costs hereunder to the extent paid by WCH), or (ii) to
exercise its right to Manufacture pursuant to Section 2.2, then IMPAX may by notice in writing to
WCH, given no later than thirty (30) days after such refusal by WCH, terminate this Agreement.
5.4 Testing by WCH. WCH may test the Product samples in accordance with the
applicable Methods of Analysis. If the analysis of any Product performed by or for WCH differs
from IMPAX’s analysis of the same Batch, WCH shall advise IMPAX and IMPAX and WCH agree to consult
with each other in order to explain and resolve the discrepancy between each other’s determination.
If, after a good faith attempt by the Parties to do so, such consultation does not resolve the
discrepancy, an independent, reputable laboratory designated by WCH and reasonably acceptable to
IMPAX (such acceptance not to be unreasonably withheld or delayed) shall repeat the applicable
Methods of Analysis on representative samples from such Batch provided by or for WCH. The costs of
the independent laboratory referred to above shall be borne by (i) WCH if such laboratory
determines that the Product conforms to the Specifications or (ii) IMPAX if such laboratory
determines that the Product does not conform to the Specifications. If so requested by WCH in
writing, IMPAX shall promptly send a new Batch of Product (of similar quantity as to the amount of
such Product being analyzed as set forth above) to WCH. WCH shall not be obligated to pay for any
Product (and if WCH has paid for such Product IMPAX shall promptly reimburse WCH) that such
laboratory determines that does not conform to the Specifications, but shall be obligated to pay
for any new Batch of Product which conforms to the Specifications that is sent as specified above,
except that IMPAX shall pay all transportation costs for such replacement Batch. If WCH shall
reject any Batch of Product, IMPAX’s only obligation and liability to WCH shall be to replace the
rejected Batch of Product.
5.5 Samples and Record Retention. IMPAX shall retain records and retention samples of
each Batch of Product for at least thirty-six (36) months after the expiration date of that Batch
and shall make the same available to WCH upon request. Retention samples shall only be destroyed
after the required holding period and then only after notice to WCH. During and after the Term,
IMPAX shall assist WCH with respect to any complaint, issue or investigation relating to Product.
5.6 Inspection.
5.6.1 IMPAX shall give access to representatives of WCH, at all reasonable times and upon
reasonable notice during regular business hours, to the Facility and any other facility in which
Products are Manufactured, tested and/or stored, and to all Manufacturing records with respect to
Products for the purpose of inspection. WCH shall have the right while at any such Facility to
inspect IMPAX’s records, permits, and licenses to evaluate work practices and compliance with all
applicable FDA and other Regulatory Authority laws and regulations,
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occupational health and safety,
and environmental laws and regulations, controlled substances laws
and regulations, GMP and warehousing practices and procedures. Upon WCH’s request, IMPAX shall
provide copies of Batch records, quality control, quality assurance and validation documents
reasonably relating to the Product. Notwithstanding any inspection performed by WCH, IMPAX shall
remain solely responsible for operating its Facilities and for complying with its obligations under
this Agreement. Neither the rights granted to WCH pursuant to this Section 5.6.1, nor any
inspection performance by WCH, shall impose any liability on WCH, except in the case of gross
negligence or willful misconduct on the part of WCH.
5.6.2 At any time during which WCH is Manufacturing Product pursuant to Section 2.2, WCH shall
give access to representatives of IMPAX, at all reasonable times and upon reasonable notice during
regular business hours, to the facility in which Products are Manufactured, tested and/or stored,
and to all Manufacturing records with respect to Products, for the purpose of inspection. IMPAX
shall have the right while at any such facility to inspect WCH’s records, permits, and licenses to
evaluate work practices and compliance with all applicable FDA and other Regulatory Authority laws
and regulations, occupational health and safety, and environmental laws and regulations, controlled
substances laws and regulations, GMP and warehousing practices and procedures. Upon IMPAX’s
request, WCH shall provide copies of Batch records, quality control, quality assurance and
validation documents reasonably related to the Product. Notwithstanding any inspection performed
by IMPAX, WCH shall remain solely responsible for operating its facilities and for complying with
its obligations under this Agreement. Neither the rights granted to IMPAX pursuant to this Section
5.6.2, nor any inspection performance by IMPAX, shall impose any liability on IMPAX, except in the
case of gross negligence or willful misconduct on the part of IMPAX.
5.7 Adverse Drug Experience Reporting. Each Party shall fully, accurately and
promptly provide to the other Party with all data known to it at any time during the term of this
Agreement or thereafter, which data indicate that any Product marketed by WCH is or may be unsafe,
lacks utility, or otherwise does not meet Specifications in accordance with the Adverse Event
Reporting Procedures set forth in Exhibit D attached hereto (as the same may be amended
from time to time by notice in writing from WCH to IMPAX). WCH shall determine whether such
information is required to be reported and report the same as required, to FDA and any other
Regulatory Authority.
5.8 Recalls and Seizure. Each Party shall keep the other Party promptly and fully
informed of any notification or other information whether received directly or indirectly which
might result in the Recall or Seizure of Product. If either Party determines that it is necessary
to Recall any Product, it shall immediately notify the other Party. Prior to commencing any
Recall, the Parties shall review with one another the manner in which the Recall is to be carried
out and any instructions or suggestions of the applicable Regulatory Authorities. IMPAX and WCH
shall effect the Recall in the manner agreed upon between the Parties in as expeditious a manner as
possible and in such a way as to cause the least disruption to the sales of any Products and to
preserve the goodwill and reputation associated with the Products and each Party. In any such
situation, WCH shall have the right to make all final decisions regarding such Recall of the
Products marketed by WCH.
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5.9 Environmental, Occupational Health and Safety. IMPAX shall report to WCH, and, if
WCH is Manufacturing Product pursuant to Section 2.2, WCH shall report to IMPAX, as soon as
possible after any of the following incidents related to the Manufacturing operations hereunder
occurs:
| (i) | significant injuries or occupational illness; | ||
| (ii) | property damage in excess of $50,000; | ||
| (iii) | inspections by any environmental protection agency or occupational health and safety agency; or | ||
| (iv) | requests for information, notices of violations or other significant governmental and safety agency communications relating to environmental, occupational health and safety compliance. |
IMPAX shall only use waste haulers, brokers and disposal sites which WCH has approved in
writing for hazardous waste generated by the Manufacturing operations, such approval not to be
unreasonably withheld or delayed. IMPAX shall have title to and be responsible for disposing in an
environmentally safe manner all residue and waste resulting from the Manufacturing operations
performed by it hereunder. IMPAX shall not use WCH trademarks or trade dress to identify any waste
materials or residues.
At any time during which WCH is Manufacturing Product pursuant to Section 2.2, WCH shall only
use waste haulers, brokers and disposal sites which IMPAX has approved in writing for hazardous
waste generated by the Manufacturing operations, such approval not to be unreasonably withheld or
delayed. WCH shall have title to and be responsible for disposing in an environmentally safe
manner all residue and waste resulting from the Manufacturing operations performed by it hereunder.
ARTICLE VI
LICENSE PAYMENTS, ROYALTIES, AND SUPPLY PRICE
LICENSE PAYMENTS, ROYALTIES, AND SUPPLY PRICE
6.1 License Payments. Subject to Section 9.3.3, WCH shall make the following
non-refundable license payments to IMPAX which shall be due and payable one (1) time only and
within thirty (30) days after the occurrence of the corresponding event set forth below
(provided that with respect to the Product to which the event relates all prior
events in the list involving such Product have occurred; and provided further
that this Agreement is in effect with respect to the Product to which the event relates at
the time of the occurrence of such event and that notice of termination shall not have been
given pursuant to Section 9.3.2 with respect to the Product to which the event relates prior to the
occurrence of such event):
| Event | Payment | |||||
(i)
|
The Effective Date of this Agreement | $ | 350,000 | |||
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| Event | Payment | |||||
(ii)
|
Placement on stability of a D-12 Product pilot batch in WCH’s consumer blister packaging | $ | 75,000 | |||
(iii)
|
Placement on stability of a D-24 Product pilot batch in WCH’s consumer blister packaging | $ | 75,000 | |||
(iv)
|
Filing with FDA an ANDA supplement/amendment for D-12 Product to support 24 month expiry based on stability studies in WCH’s consumer blister packaging | $ | 100,000 | |||
(v)
|
Filing with FDA an ANDA supplement/amendment for D-24 Product to support 24 month expiry based on stability studies in WCH’s consumer blister packaging | $ | 100,000 | |||
(vi)
|
WCH’s acceptance of successful scale-up and validation (based on WCH’s approval of final validation report) of D-12 Product | $ | 150,000 | |||
(vii)
|
WCH’s acceptance of successful scale-up and validation (based on WCH’s approval of final validation report) of D-24 Product | $ | 150,000 | |||
(viii)
|
The later to occur of (a) January 1, 2003 or (b) final D-12 Product ANDA approval by FDA with WCH’s consumer labeling and blister packaging | $ | 450,000 | |||
(ix)
|
The later to occur of (a) January 1, 2003 or (b) final D-24 Product ANDA approval by FDA with WCH’s consumer labeling and blister packaging | $ | 450,000 | |||
(x)
|
The later to occur of (a) January 1, 2003 or (b) Launch of the D-12 Product by WCH in the United States | $ | 1,250,000 | |||
(xi)
|
The later to occur of (a) January 1, 2003 or (b) Launch of the D-24 Product by WCH in the United States | $ | 1,250,000 | |||
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6.2 Royalties.
6.2.1 During the Term following the date of Launch of each Product in a country of the
Territory through the later of five (5) years from Launch in such country and the expiration of the
last to expire issued IMPAX Patent in such country, if any, WCH shall pay to IMPAX, on a quarterly
basis, a royalty of XXXXX percent (XXXXX%) on Net Sales of such Product (whether or not
Manufactured by IMPAX, WCH pursuant to Section 2.2 or WCH’s sublicensees pursuant to Section 2.1.2)
sold for the OTC Field on a country-by-country basis in the Territory during the previous quarter.
6.2.2 During any period and for each country that royalties are due and payable pursuant to
Section 6.2.1, WCH shall, within thirty (30) days after each calendar quarter for sales of Product
for the OTC Field in the United States and within sixty (60) days after each calendar quarter for
sales of Product for the OTC Field within the Territory outside the United States, furnish to IMPAX
a written quarterly report showing (i) the Net Sales of Product for the OTC Field sold by WCH and
its Affiliates and sublicensees pursuant to Section 2.1.2 during the reporting period in such
country; (ii) the royalties which shall have accrued hereunder in respect of such sales in such
country; (iii) withholding taxes, if any, required by law to be deducted in respect of such royalty
payments; and (iv) the exchange rates used in determining the amount of payment hereunder.
6.2.3 Payments accrued in each quarter shall be paid to IMPAX no later than thirty (30) days
after the end of such quarter for the United States and no later than sixty (60) days after the end
of such quarter for all other countries. Any amounts not paid within thirty (30) days after the
due date thereof shall bear interest at the rate equal to eighteen percent (18%) per annum.
6.2.4 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.
6.3 Supply Price.
6.3.1 IMPAX shall invoice WCH for the prices set forth in Exhibit B attached hereto,
subject to adjustment as set forth in Sections 6.3.2, 6.3.3 and 6.3.4, for all Products delivered
to WCH hereunder. All prices are inclusive of taxes, shipping costs to the point of delivery,
customs duties and other charges.
6.3.2 The Direct Manufacturing Cost, and the quality control, Materials, labor and overhead
components thereof, as of June 1, 2002 which formed the basis of the price for each Product are set
forth on Exhibit B attached hereto. IMPAX shall use Commercially Reasonable
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Efforts to minimize the Direct Manufacturing Cost of each Product. Commencing with June 1, 2003
and each December 1st and June 1st thereafter (in each case, an “Adjustment
Date”), IMPAX may propose an adjustment to the prices to reflect documented changes in Direct
Manufacturing Cost per unit of Product on such June 1st or December 1st, as
the case may be, as compared to the Direct Manufacturing Cost per unit of Product on June 1, 2002
for the first adjustment and thereafter on the immediately preceding June 1st or
December 1st, as the case may be, (without regard to intervening fluctuations);
provided that IMPAX gives WCH not less than ninety (90) days’ prior written notice
of any proposed price increase and that IMPAX may not increase the price of a Product more than
once during any Contract Year; and provided, further, that any such
increase shall not exceed the relevant PPI Adjustment. If WCH does not accept IMPAX’s proposed
price increases, the Parties shall negotiate in good faith. If the Parties conclude their
negotiations and agree upon Product prices, such agreed upon price increases shall be effective as
of the expiration of such ninety (90) day notice period. In the event that the Parties are unable
to agree during the negotiations described above, this Agreement shall be automatically terminated
effective six (6) months after the expiration of such ninety (90) day notice period. Until the
date of such termination, IMPAX shall supply WCH such Products at the prices then in effect without
such price increase. “PPI Adjustment” means the amount calculated in accordance with the following
formula:
DMC x PPI – BPPI
BPPI
Where, DMC |
= | Direct Manufacturing Cost on June 1, 2002 for the first adjustment and thereafter on the Adjustment Date immediately preceding the Adjustment Date in question; | ||
BPPI
|
= | the Bureau of Labor Statistics Producer’s Price Index for Pharmaceutical Preparations (Code 2834) on June 1, 2002 for the first adjustment and thereafter on the Adjustment Date immediately preceding the Adjustment Date in question; and | ||
PPI
|
= | the Bureau of Labor Statistics Producer’s Price Index for Pharmaceutical Preparations (Code 2834) on the Adjustment Date in question. |
6.3.3 Continuous improvement initiatives, mutually agreeable to the Parties shall be
established to provide for continuous cost reductions during the Term of this Agreement. Continuous
improvement teams consisting of equal representation from each Party shall use reasonable efforts
to work to identify and implement cost savings at a targeted rate of five percent (5%) of WCH’s
purchase price per Contract Year, but the foregoing shall not constitute a guarantee by IMPAX of
any cost reductions. Any documented savings shall be allocated to the Parties in proportion to the
level of contribution by each Party to realize the savings. Any cost savings allocated to WCH
shall be in the form of reduced purchase price.
6.3.4 Notwithstanding any provision herein to the contrary, if at any time IMPAX makes sales
of any Product to any person in any country of the Territory at a price lower than the price then
in effect hereunder for such Product, such lower price shall be made available
to WCH hereunder, with respect to WCH’s inventory of Product in such country as well as future
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purchases of Product for resale in such country, for so long as IMPAX continues to make sales to
such person at such lower price.
6.3.5 WCH shall pay invoices for Products delivered hereunder in $ not later than thirty (30)
days after the later of receipt of Products covered by such invoice and receipt of such invoice.
In addition to its other rights and remedies, IMPAX shall have the right to assess interest on
amounts past due by more than fifteen (15) days at the rate of one and one-half percent (11/2%) per
month, or the highest rate permissible by law, if lower.
6.4 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 IMPAX and shall be paid to the proper taxing authority. Proof of payment shall be
secured, if available, and sent to IMPAX 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.
6.5 Audit Rights. WCH shall have the right, at its own expense, through its
independent certified public accountant (reasonably acceptable to IMPAX) to access the books and
records of IMPAX and its Affiliates, as may be reasonably necessary, to verify the accuracy of
IMPAX’s Direct Development Costs and Direct Manufacturing Costs. IMPAX shall have the right, at
its own expense, through its independent certified public accountant (reasonably acceptable to WCH)
to access the books and records of WCH and its Affiliates, as may be reasonably necessary, to
verify the accuracy of WCH’s Net Sales. Such access shall be conducted after thirty (30) days’
prior written notice to the Party being audited and during ordinary business hours and shall not be
more frequent than once per Contract Year or in respect of any Contract Year ending more than
thirty-six (36) months prior to the date of such notice. If such independent certified public
accountant’s report shows any overpayment or underpayment by a Party, the other Party shall remit
to such Party within thirty (30) days after such Party’s receipt of such report, (i) the amount of
such overpayment or underpayment, as the case may be, (ii) interest on such overpayment or
underpayment, as the case may be, at the prime rate quoted by Chase Manhattan Bank N.A. from the
date payment was first due until the date of payment of such overpayment or underpayment, as the
case may be, and (iii) if such overpayment or underpayment, as the case may be, exceeds five
percent (5%) of the total amount owed for the period then being audited, the reasonable fees and
expenses of any independent accountant performing the audit on behalf of such Party.
ARTICLE VII
REPRESENTATIONS AND WARRANTIES
REPRESENTATIONS AND WARRANTIES
7.1 Representation and Warranties of Each Party. Each of WCH and IMPAX hereby
represents and warrants to the other Party hereto as follows:
7.1.1 it is a corporation or entity duly organized and validly existing under the laws of the
state or other jurisdiction of incorporation or formation;
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7.1.2 the execution, delivery and performance of this Agreement by such Party has been duly
authorized by all requisite corporate action and do not require any shareholder action or approval;
7.1.3 it has the power and authority to execute and deliver this Agreement and to perform its
obligations hereunder;
7.1.4 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) any other contract
entered into by such Party; (ii) a loan agreement, guaranty, financing agreement, agreement
affecting a product or other agreement or instrument binding or affecting it or its property; (iii)
the provisions of its charter or operative documents or by laws; or (iv) any order, writ,
injunction or decree of any court or governmental authority entered against it or by which any of
its property is bound; and
7.1.5 is in compliance with all applicable laws and regulations relating to its activities
under this Agreement.
7.2 Representations and Warranties of IMPAX.
7.2.1 IMPAX hereby represents and warrants to WCH with respect to each delivery of Products
that:
| (i) | the Products (a) have been Manufactured in the United States; (b) have been Manufactured, stored and shipped in accordance with GMPs and all applicable laws, rules, regulations or requirements in effect at the time of Manufacture; (c) conform to the Specifications, are free from defects and are merchantable; (d) at the point of shipment to WCH or WCH’s designee are not adulterated or misbranded; and (e) have been shipped and stored in accordance with approved procedures agreed between WCH and IMPAX; | ||
| (ii) | the D-12 Products and D-24 Products are pharmaceutically equivalent and bioequivalent to CLARITIN-D® 12-hour Extended Release Tablets and CLARITIN-D® 24-hour Extended Release Tablets, respectively; | ||
| (iii) | IMPAX has good and marketable title to all Products and Products are free from all liens, charges, encumbrances and security interests; | ||
| (iv) | to the knowledge of IMPAX, (A) as of the Effective Date and (B) thereafter, except as disclosed in writing by IMPAX to WCH, the Manufacture, use, importation, offer for sale and sale of Products do not infringe any intellectual property rights of any Third Party, |
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| including but not limited to U.S. Patents 4,659,716; 4,863,931; 6,335,347; and 5,314,697 and any foreign counterparts thereof; |
| (v) | the Facilities conform in all respects to applicable law governing such Facilities; and | ||
| (vi) | neither IMPAX nor its Affiliates used in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(l) and further it did not use any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Products or any service rendered to WCH. |
7.2.2 IMPAX hereby represents and warrants with respect to the IMPAX Patents and Technical
Information:
| (i) | IMPAX has no knowledge that the IMPAX Patents (a) are not valid and enforceable; or (b) are dominated or the practice of then claimed subject matter infringes the intellectual property rights of any Third Party in the Territory as of the Effective Date; | ||
| (ii) | IMPAX has the full right, power and authority to grant the licenses set forth in Sections 2.1 and 2.2; | ||
| (iii) | IMPAX has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Products, the IMPAX Patents or the Technical Information in the OTC Field in the Exclusive Territory; and | ||
| (iv) | IMPAX is the sole and exclusive owner of the IMPAX Patents and Technical Information free and clear of all liens, charges, encumbrances and security interests. |
7.3 Representations and Warranties of WCH.
7.3.1 WCH hereby represents and warrants to IMPAX that with respect to any Product that WCH or
one of its Affiliates Manufactures pursuant to Section 2.2:
| (i) | such Products (a) have been Manufactured, stored and shipped in accordance with GMPs and all applicable laws, rules, regulations or requirements in effect at the time of Manufacture; (b) conform to the Specifications, are free from defects and are merchantable; (c) are not adulterated or misbranded; and (d) have been shipped and stored in accordance with approved procedures agreed between WCH and IMPAX; |
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| (ii) | WCH’s and/or its Affiliates’ manufacturing facilities for such Products conform in all respects to applicable law governing such facilities; and | ||
| (iii) | neither WCH nor its Affiliates used in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(l) and further it did not use any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Products. |
7.3.2 WCH hereby represents and warrants to IMPAX that all Products which WCH shall market,
store, sell, distribute, import and export under this Agreement shall have been marketed, stored,
sold, distributed, imported and exported in accordance with applicable law.
7.4 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.
7.5 No Further Warranties. EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, CONCERNING THE
PRODUCTS OR THE MERCHANTABILITY OR FITNESS THEREOF FOR ANY PURPOSE.
ARTICLE VIII
INDEMNIFICATION AND INSURANCE
INDEMNIFICATION AND INSURANCE
8.1 Indemnification.
8.1.1 IMPAX shall indemnify, defend and hold harmless WCH, its Affiliates and their respective
directors, officers, employees and agents from and against all damages, losses, liabilities,
expenses, claims, demands, suits, penalties or judgments or administrative or judicial orders
(including reasonable attorneys’ fees and expenses) (“Costs”) incurred, assessed or sustained by or
against WCH, its directors, officers, employees or agents with respect to or arising out of (i) the
negligent or willful acts or omissions or strict liability of IMPAX; (ii) any breach by IMPAX of
its representations, warranties or covenants hereunder; (iii) any Recall or Seizure attributable to
IMPAX’s performance; (iv) any allegation that the Manufacture, importation, sale, offer for sale or
use of any Product in the United States infringes any Patent or other proprietary or protected
right, other than trademark rights; or (v) IMPAX’s failure to comply with any applicable law,
regulation or order (including but not limited to environmental laws, regulations and orders, and
laws and orders relating to the Manufacture, storage, sale, import and export of Products).
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8.1.2 WCH shall indemnify, defend and hold harmless IMPAX, its Affiliates and their respective
directors, officers, employees and agents from and against all damages, losses, liabilities,
expenses, claims, demands, suits, penalties or judgments or administrative or judicial orders
(including reasonable attorneys’ fees and expenses) incurred, assessed or sustained by or against
IMPAX, its directors, officers, employees or agents with respect to or arising out of (i) the
negligent or willful acts or omissions or strict liability of WCH; or (ii) any breach by WCH of its
representations, warranties or covenants hereunder; or (iii) any Recall or Seizure attributable to
WCH’s performance; (iv) any allegation that the importation, sale, offer for sale or use of any
Product by WCH in any country in the Exclusive Territory outside the United States infringes any
Patent or other proprietary or protected right; or (v) WCH’s failure to comply with any applicable
law, regulation or order (including but not limited to environmental laws, regulations and orders,
and laws and orders related to the Manufacture (if WCH is Manufacturing Product pursuant to Section
2.2), storage, marketing, distribution, sale, import and export of the Products).
8.1.3 Each Party and its Affiliates and their respective directors, officers, employees or
agents (an “Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”),
in writing, of any claim asserted or threatened against such Indemnified Party for which such
Indemnified Party is entitled to indemnification hereunder from the Indemnifying Party. With
respect to any such claim the Indemnified Party shall, at no out-of-pocket expense to it,
reasonably cooperate with and provide such reasonable assistance to such Indemnifying Party as such
Indemnifying Party may reasonably request. Such reasonable assistance may include, without
limitation, providing copies of all relevant correspondence and other materials that the
Indemnifying Party may reasonably request. The obligations of an Indemnifying Party under Sections
8.1.1 and 8.1.2 are conditioned upon the delivery of written notice to the Indemnifying Party of
any asserted or threatened claim promptly after the Indemnified Party becomes aware of such claim;
provided, that the failure of the Indemnified Party to give such notice or any
delay thereof shall not affect the Indemnified Party’s right to indemnification hereunder, except
to the extent that such failure or delay impairs the Indemnifying Party’s ability to defend or
contest any such claim. The Indemnifying Party shall have the right to assume the defense of any
suit or claim for which indemnification is sought. 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. An Indemnifying Party may not settle a suit or claim, without the consent of the
Indemnified Party, if such settlement would impose any monetary obligation on the Indemnified Party
for which indemnification is not provided hereunder or require the Indemnified Party to submit to
an injunction or otherwise limit the Indemnified Party’s rights under this Agreement. Any payment
made by an Indemnifying Party to settle any such suit or claim shall be at its own cost and
expense.
8.1.4 With respect to any claim by one Party against the other Party arising out of the
performance or failure of performance of the other Party under this Agreement, the Parties
expressly agree that the liability of such Party to the other Party for such breach shall be
limited under this Agreement or otherwise at law or equity to direct damages only and in no event
shall a Party be liable for lost profits, punitive, exemplary or consequential damages;
provided, however, that such limitation shall not apply with respect to the
obligations of either Party to
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indemnify the other under Sections 8.1.1 or 8.1.2 hereof in connection with a liability to a Third
Party.
8.2 Insurance. Each Party shall maintain the following kinds of insurance with the
minimum limits set forth below.
| Kind of Insurance | Minimum Limits | |
Commercial General Liability, including
Contractual, Completed Operations and
Products Liability
|
$2,000,000 Per Occurrence $5,000,000 Aggregate |
|
Workers Compensation
|
Statutory with Employer’s Liability of not less than $1,000,000 Per Accident/Disease | |
Automobile Bodily Injury Liability
(including hired automobile and
non-ownership Liability)
|
$1,000,000 Each Accident Combined Single Limit |
WCH may be self insured for such amounts. Upon request, IMPAX shall furnish insurance
certificates as directed by WCH, satisfactory in form and substance to WCH, showing the above
coverages, and providing for at least ten (10) days’ prior written notice to WCH by the insurance
company of cancellation or modification. WCH shall be named as an additional insured on the
IMPAX’s policies. Coverage shall be procured with carriers having an A.M. Best rating of A-VII or
better.
ARTICLE IX
TERM AND TERMINATION
TERM AND TERMINATION
9.1 Term. This Agreement shall commence on the Effective Date and continue, unless
sooner terminated as set forth below in this Article IX or in Article XII or Sections 5.3.2, 6.3.2
or 14.10, until the later to occur of (i) the fifth anniversary of the Launch date of a Product in
the United States or (ii) the date of the expiration of the last to expire of the IMPAX Patents
(the “Term”).
9.2 Termination by Either Party.
9.2.1 If either Party shall materially breach any of its obligations hereunder and shall fail
to correct such breach within thirty (30) days after the other Party shall have given notice to it
thereof, the aggrieved Party shall be entitled to notify the other Party that it intends to
terminate this Agreement unless such breach is corrected and may so terminate ten (10) days after
the end of such thirty (30) day period if such breach is continuing, unless, to the extent the
breach can be cured, the time period of thirty (30) days is not sufficient to cure such breach in
which event the Party in breach shall have such additional time as shall be reasonably necessary to
cure such breach, but in
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no event to exceed six (6) months. Such termination shall not give rise to the payment of any
penalty, damages or indemnity by the terminating Party.
9.2.2 If either Party by voluntary or involuntary action goes into liquidation, dissolves or
files a petition for bankruptcy or suspension of payments, is adjudicated bankrupt, has a receiver
or trustee appointed for its property or estate, becomes insolvent or makes an assignment for the
benefit of creditors, the other Party shall be entitled by notice in writing to such Party to
terminate this Agreement forthwith. Such termination shall not give rise to the payment of any
penalty, damages or indemnity by the terminating Party.
9.2.3 If, upon the decision of a court of competent jurisdiction from which either no appeal
can be taken or the time for an appeal has expired without an appeal having been filed, a claim is
upheld that the Manufacture, storage, importation, sale, offer to sell or use of the Product, or
Products, respectively, infringes any Patent or other proprietary or protected right (other than
trademark rights) of a Third Party, then either Party shall have the right to immediately terminate
this Agreement, upon written notice to the other Party, as to the country or other geographic area,
and Product, or Products, respectively, covered by the Patent or other proprietary or protected
right. Upon any such termination by WCH, WCH shall have no further rights to such Product or
Products in that country or geographic area.
9.3 Termination by WCH.
9.3.1 WCH may terminate this Agreement upon ten (10) days’ written notice to IMPAX either in
its entirety, or with respect to the Product to which the event relates, if any of the following
events does not occur by the date set forth opposite such event:
| Event | Date | |||
(i)
|
Successful completion of scale-up and validation (based on WCH’s approval of final validation report) for the D-12 Product | The later of (i) November 30, 2002 or (ii) ninety (90) days from the date on which WCH provides IMPAX with the Identity Criteria for the D-12 Product or notifies IMPAX in writing that none are required | ||
(ii)
|
Successful completion of scale-up and validation (based on WCH’s approval of final validation report) for the D-24 Product | The later of (i) June 30, 2003 or (ii) ninety (90) days from the date on which WCH provides IMPAX with the Identity Criteria for the D-24 Product or notifies IMPAX in writing that none are required | ||
(iii)
|
Final ANDA approval (which | August 30, 2003 | ||
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| Event | Date | |||
| includes without limitation WCH’s consumer labeling and blister packaging) of D-12 Product by FDA | ||||
(iv)
|
Final ANDA approval (which includes without limitation WCH’s consumer labeling and blister packaging) of D-24 Product by FDA | March 31, 2004 | ||
(v)
|
Failure to deliver at least seventy-five percent (75%) of the Launch quantities of D-12 Product consistent with the forecasts required by Section 4.2 | Four and one-half (41/2) months after the later of (i) receipt of WCH’s purchase order therefor or (ii) the date on which WCH provides IMPAX with the Identity Criteria for the D-12 Product or notifies IMPAX in writing that none are required | ||
(vi)
|
Failure to deliver at least seventy-five percent (75%) of the Launch quantities of D-24 Product consistent with the forecasts required by Section 4.2 | Four and one-half (41/2) months after the later of (i) receipt of WCH’s purchase order therefor or (ii) the date on which WCH provides IMPAX with the Identity Criteria for the D-24 Product or notifies IMPAX in writing that none are required | ||
Such termination shall not give rise to the payment of any penalty, damages or indemnity by either
Party and WCH shall have no further rights under Sections 2.1 and 2.2, except where the event is a
failure to deliver Launch quantities of the D-12 and D-24 Product in which case the provisions of
Section 9.5.1 shall apply.
9.3.2 WCH may terminate this Agreement either in its entirety or with respect to any Product
upon three (3) months’ written notice to IMPAX. If WCH terminates this Agreement pursuant to this
Section 9.3.2, then WCH shall make the following payments with respect to the Product so
terminated:
| Event | Payment | |||
I. D-12 Product |
||||
If on or before the date on which notice of
termination is given for the D-12 Product the event
described in |
||||
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| Event | Payment | |||
Section 6.1(viii) has not occurred |
$ | 450,000 | ||
| or | ||||
If on or before the date on which notice of
termination is given for the D-12 Product the event
described in Section 6.1(viii) has occurred but the
event described in Section 6.1(x) has not occurred |
$ | 675,000 | ||
| or | ||||
If on or before the date on which notice of
termination is given for the D-12 Product the event
described in Section 6.1(x) has occurred |
Zero | |||
II. D-24 Product |
||||
If on or before the date on which notice of
termination is given for the D-24 Product the event
described in Section 6.1(ix) has not occurred |
$ | 450,000 | ||
| or | ||||
If on or before the date on which notice of
termination is given for the D-24 Product the event
described in Section 6.1(ix) has occurred but the
event described in Section 6.1(xi) has not occurred |
$ | 675,000 | ||
| or | ||||
If on or before the date on which notice of
termination is given for the D-24 Product the event
described in Section 6.1(xi) has occurred |
Zero | |||
It is understood and agreed that the amounts set forth above are in lieu of and not in addition to
the license payments for the corresponding event set forth in Section 6.1 and that, effective upon
termination, WCH’s obligation to make future license payments with respect to any terminated
Product shall be canceled. Except as specifically set forth above, such termination shall not give
rise to the payment of any penalty, damages or indemnification by either Party and WCH shall have
no further rights to the Product or Products to which such termination applies.
9.3.3 In addition to, and not in limitation on, WCH’s rights under Section 9.2.3, WCH may
terminate this Agreement in its entirety or with respect to any Product immediately (i) if FDA
takes any action (provided that with respect to such action either (a) no appeal
can be taken or the time for an appeal has expired without an appeal having been filed or an appeal
has been filed and FDA’s action has been upheld or (b) such action is a final regulatory action),
the result of which is to prohibit the Manufacture, storage, importation, sale, offer for sale or
use of the Products or a Product, respectively; (ii) if the Loratadine to be used by IMPAX to
Manufacture Product does not meet the Identity Criteria upon completion of the initial analysis by
SSCI, Inc. (or such other contract laboratory specified by WCH); provided that such
notice of termination is given by WCH in this subparagraph (ii) by no later than March 31, 2003;
(iii) if the Loratadine to be used by IMPAX to Manufacture Product is not determined upon testing
by WCH to be outside the scope of PCT patent application (WO 02/05816 AI) or any Patent that issues based thereon; or (iv) if a
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decision is rendered in favor of Schering in any of the Patent Litigations either by a United
States District Court and the time for an appeal has expired without an appeal having been filed,
or by the United States Court of Appeals for the Federal Circuit and the time for an appeal has
expired without an appeal having been filed, or by the United States Supreme Court. Notwithstanding
the foregoing, (a) if a United States District Court renders a decision in favor of Schering with
respect to the ‘716 Patent, then WCH’s obligation to make any further payments under Section 6.1
shall be suspended until such time as the decision in favor of Schering is reversed and a final
decision from which no appeal can be taken is entered in IMPAX’s favor in such case; and (b) if a
United States District Court renders a decision in favor of Schering with respect to the ‘697
Patent, then WCH’s obligation to make any further payments under Section 6.1 with respect to the
D-24 Product shall be suspended until such time as the decision in favor of Schering is reversed
and a final decision from which no appeal can be taken is entered in IMPAX’s favor in such case.
Such termination shall not give rise to the payment of any penalty, damages or indemnity by WCH and
WCH shall have no further rights to such Product so terminated.
9.3.4 In addition to, and not in limitation on, WCH’s rights under Section 9.2.3, WCH may
terminate this Agreement with respect to any Product in a country (other than the United States
which is provided for in Section 9.3.3) in which a Regulatory Authority has taken any action (with
respect to such action either (a) no appeal can be taken, or the time for an appeal has expired
without an appeal having been filed or an appeal has been filed and such Regulatory Authorities’
action has been upheld or (b) such action is a final regulatory action), the result of which is to
prohibit the Manufacture, storage, importation, sale, offer for sale or use of the Products or a
Product respectively, or an action is commenced alleging that the Manufacture, storage,
importation, sale, offer for sale or use of the Products or a Product, respectively, infringe any
Patent or other proprietary or protected right of any Third Party in such country. Such
termination shall not give rise to the payment of any penalty, damages or indemnity by WCH and WCH
shall have no further rights to such country so terminated.
9.4 Termination by IMPAX.
9.4.1 If IMPAX requests in writing that WCH file an application for Regulatory Approval for a
Product in the OTC Field in a particular country in the Exclusive or Semi-Exclusive Territory
(other than the United States) and if WCH does not commence using Commercially Reasonable Efforts
to submit such an application within six (6) months, then IMPAX, at its option and as its sole and
exclusive remedy, may terminate this Agreement with respect to such Product in such country
(thereby modifying the Exclusive or Semi-Exclusive Territory to exclude such Product in such
country) by providing six (6) months’ written notice to WCH, and WCH shall have no further rights
to such Product in such country. Such modification shall not give rise to the payment of any
penalty, damages or indemnification by either Party.
9.4.2 If WCH fails to use Commercially Reasonable Efforts to Launch a Product in a country of
the Exclusive or Semi-Exclusive Territory within one (1) year after having obtained FTO Status for
such Product in the OTC Field in such country, IMPAX, at its option and as its sole and exclusive
remedy, may terminate this Agreement with respect to such Product in such country
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(thereby modifying the Exclusive or Semi-Exclusive Territory to exclude such Product in such country) by
providing six (6) months’ written notice to WCH. Such modification shall not give rise
to the payment of any penalty, damages or indemnification by either Party and WCH shall have no
further rights to such Product in such country.
9.5 Effect of Expiration or Termination.
9.5.1 Upon expiration of this Agreement pursuant to Section 9.1 (i) or (ii) or termination by
WCH pursuant to Section 9.2.2, 9.3.1(v) or 9.3.1(vi) or termination by IMPAX pursuant to 9.2.3
(provided that in the case of termination by IMPAX pursuant to Section 9.2.3 only,
(i) upon IMPAX’s written request prior to termination by IMPAX, WCH shall cooperate with IMPAX in
attempting to identify a means to address or avoid the subject infringement, (ii) the license set
forth below is limited to the countries or geographic area to which such termination applies and
(iii) WCH provides IMPAX with an indemnity agreement acceptable to IMPAX for any damages assessed
against IMPAX, arising out of WCH’s exercise of the license set forth below, for infringement of
such Patent or other proprietary or protected right, such acceptance not to be unreasonably
withheld or delayed), WCH shall have the fully paid-up, royalty free, perpetual, irrevocable
(except that such license may be terminated pursuant to the proviso set forth below), non-exclusive
license, with the right to grant sublicenses, to make, have made, market, promote, use, distribute,
sell, have sold, import and export Products for the OTC Field within the Territory pursuant to the
Regulatory Documents, the IMPAX Patents and IMPAX’s Technical Information (including manufacturing
know-how); provided that if WCH breaches the terms of the license set forth in this
Section 9.5.1 and fails to correct such breach within ten (10) days after notice in writing from
IMPAX, IMPAX may terminate this license if such breach is continuing by notice in writing given at
the end of such ten (10) day period.
9.5.2 Upon termination of this Agreement by WCH for an uncured material breach of this
Agreement pursuant to Section 9.2.1, WCH shall have a fully paid up, royalty free, perpetual,
irrevocable (except that such license may be terminated pursuant to the proviso set forth below),
non-exclusive license, with the right to grant sublicenses, to make, have made, market, promote,
use, distribute, sell, have sold, import and export Products for the OTC Field within the Territory
pursuant to the Regulatory Documents, the IMPAX Patents and IMPAX’s Technical Information
(including manufacturing know-how); provided that if WCH breaches the terms of the
license set forth in this Section 9.5.2 and fails to correct such breach within ten (10) days after
notice in writing from IMPAX, IMPAX may terminate this license if such breach is continuing by
notice in writing given at the end of such ten (10) day period.
9.5.3 In the event that WCH terminates this Agreement under the circumstances described in
Section 9.5.1 or 9.5.2, (i) IMPAX shall promptly but no later than within thirty (30) days after
receipt of notice of such termination, furnish to WCH, on a non-exclusive basis, all of IMPAX’s
Technical Information (including manufacturing know-how) as relates to Product for the OTC Field in
the Territory and (ii) IMPAX shall, within thirty (30) days of a request by WCH, furnish to WCH
and/or its Affiliates all Regulatory Documents which relate to Product for the OTC Field in the
Territory. Upon WCH’s request, IMPAX shall within the same period deliver to WCH or its designees
full copies, at WCH’s expense, (both paper and electronic,
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where available) of any Regulatory
Documents in IMPAX’s or its Affiliates’ possession or control and provide all technical assistance,
at WCH’s cost, reasonably requested by WCH. IMPAX agrees to promptly execute and deliver any additional documents and instruments, and perform
any additional acts, that may be reasonably necessary to effect this right.
9.5.4 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.
9.5.5 Termination or expiration of this Agreement, in whole or in part, shall be without
prejudice to the right of either Party to receive all payments accrued and unpaid at the effective
date of such termination or expiration, without prejudice to the remedy of either Party in respect
to any previous breach of any of the representations, warranties or covenants herein contained and
without prejudice to any other provisions hereof which expressly or necessarily call for
performance after such termination or expiration.
9.5.6 The following provisions shall survive the expiration or termination of this Agreement:
Section 9.5 and Articles I, VII, VIII, X and XIV, in each case for the time periods and subject to
the limitations set forth therein.
ARTICLE X
CONFIDENTIALITY
CONFIDENTIALITY
10.1 Nondisclosure Obligation. Each of IMPAX and WCH shall use only in connection
with the Manufacture of Product or otherwise in accordance with this Agreement and shall not
disclose to any Third Party the Confidential Information received by it from the other Party
pursuant to this Agreement, without the prior written consent of the other Party. The foregoing
obligations shall survive for a period of five (5) years after the termination or expiration of
this Agreement. These obligations shall not apply to Confidential Information that:
| (i) | is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by business records; |
| (ii) | is at the time of disclosure or thereafter becomes published or otherwise part of the public domain without breach of this Agreement by the receiving Party; |
| (iii) | is subsequently disclosed to the receiving Party by a Third Party who has the right to make such disclosure; |
| (iv) | is developed by the receiving Party independently of the Confidential Information received from the disclosing Party and such independent development can be documented by the receiving Party; or |
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| (v) | is required by law, regulation, rule, act or order of any governmental authority or agency to be disclosed by a Party, provided that notice is promptly delivered to the other Party in order to provide an opportunity to seek a protective order or other similar order with respect to such Confidential Information and thereafter the disclosing Party discloses to the requesting entity only the minimum Confidential Information required to be disclosed in order to comply with the request, whether or not a protective order or other similar order is obtained by the other Party. |
10.2 Permitted Disclosures. Each Party may disclose the other Party’s Confidential
Information to its employees and Affiliates on a need-to-know basis and to its agents, counsel or
consultants to the extent required to accomplish the purposes of this Agreement; provided
that the recipient Party obtains prior agreement from such agents and consultants to whom
disclosure is to be made to hold in confidence and not make use of such Confidential Information
for any purpose other than those permitted by this Agreement. WCH may disclose IMPAX Confidential
Information in connection with seeking Regulatory Approval of Products. Each Party will use at
least the same standard of care as it uses to protect proprietary or confidential information of
its own to ensure that such employees, agents, consultants, and Affiliates do not disclose or make
any unauthorized use of the other Party’s Confidential Information, but in no event less than a
reasonable degree of care.
10.3 Disclosure of Agreement. Neither IMPAX nor WCH shall release to any Third Party
or publish in any way any non-public information with respect to the terms of this Agreement
without the prior written consent of the other Party, which consent shall not be unreasonably
withheld or delayed, provided that, either Party may disclose the terms of this
Agreement
| (i) | to the extent required to comply with applicable laws, including, without limitation the rules and regulations promulgated by the United States Securities and Exchange Commission; provided, further, that prior to making any such disclosure, the Party intending to so disclose the terms of this Agreement shall (a) provide the nondisclosing Party with written notice of the proposed disclosure and an opportunity to review and comment on the intended disclosure which is reasonable under the circumstances and (b) shall seek confidential treatment for as much of the disclosure as is reasonable under the circumstances, including, without limitation, seeking confidential treatment of any information as may be requested by the other Party; or |
| (ii) | to one or more Third Parties and/or their advisors in connection with a proposed spin-off, joint venture, divestiture, merger or other similar transaction involving all, or substantially all, of the assets or business of the disclosing Party to which this Agreement relates or to lenders, investment bankers and other financial institutions of its choice solely for purposes of financing the business operations of such Party; provided, |
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| further, that either (a) upon the written consent of the other Party or (b) if the disclosing Party uses reasonable efforts to obtain a signed confidentiality agreement with such Third Parties with respect to such information on terms no less restrictive than those contained in this Article X. |
10.4 Publicity. Subject to Section 10.3, all publicity, press releases and other
announcements relating to this Agreement or the transactions contemplated hereby shall be reviewed
in advance by, and shall be subject to the approval of, both Parties.
ARTICLE XI
TRADEMARKS; INFRINGEMENT OF IMPAX PATENTS
TRADEMARKS; INFRINGEMENT OF IMPAX PATENTS
11.1 Trademarks. WCH may advertise, promote, market and sell Products under any
trademarks, copyrights, tradenames or logos, whether registered or unregistered, selected by WCH in
its sole discretion. IMPAX shall have no right, title or interest in or to any such trademark,
copyright, tradename or logo. So long as WCH or any Affiliate of WCH shall have any interest in
any such trademark, copyright, tradename, or logo, whether registered or unregistered, whether as
proprietor, owner, or licensee in any country of the world, IMPAX shall not adopt, use, apply for
registration, register or own such trademark, copyright, tradename, or logo, or any such item
confusingly similar thereto in any country of the world, or take any action which, in WCH’s sole
opinion, weakens or undermines WCH’s proprietary rights.
11.2 Infringement of IMPAX Patents.
11.2.1 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 IMPAX 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.
11.2.2 Except as provided in Section 11.2.4, IMPAX 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 IMPAX Patents. IMPAX 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. IMPAX 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.
11.2.3 IMPAX shall have the sole and exclusive right to select counsel for any suit referred
to in Section 11.2.2 and shall, except as provided below, pay all expenses of the suit, including
without limitation attorneys’ fees and court costs. In the event that WCH elects
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not to contribute
to the costs of such litigation, IMPAX 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 IMPAX therewith at no charge to IMPAX 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. IMPAX 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.
11.2.4 In the event that IMPAX elects not to initiate an infringement or other appropriate
suit pursuant to Section 11.2.2 above on account of a Related Infringement after reasonable efforts
to ▇▇▇▇▇ such Related Infringement without litigation have failed, but in no event later than one
hundred and twenty (120) days after WCH’s notice to IMPAX under Section 11.2.1, IMPAX 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 Section
11.2.4, WCH 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.
IMPAX, 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 IMPAX 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 IMPAX 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, IMPAX 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, IMPAX shall offer reasonable assistance to WCH in
connection therewith at no charge to WCH except for reimbursement of reasonable out-of-pocket
expenses incurred in rendering such assistance. IMPAX shall have the right to participate and be
represented in any such suit by its own counsel at its own expense.
ARTICLE XII
FORCE MAJEURE
FORCE MAJEURE
12.1 Force Majeure. If the production, delivery, acceptance, or use of Products
specified for delivery under this Agreement, or the performance of any other obligation of one of
the Parties hereunder is prevented, restricted or interfered with by reason of any cause or event
beyond the reasonable control of such Party and without the fault or negligence of such Party, the
Party so affected, upon prompt notice to the other Party (including a statement of impact), shall
be excused from performing such obligation during the continuance of such event. If such event
continues for a period of ninety (90) consecutive days or more the other Party may terminate this
Agreement by
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notice in writing provided that such event of force majeure is
continuing. If as a result or any of the force majeure events described above, IMPAX is unable to
fully supply WCH’s orders hereunder, IMPAX shall allocate all available quantities of Materials and
Products to WCH in the ratio that the quantities ordered by WCH in twelve (12) month period
immediately preceding such force majeure event bears to IMPAX’s requirements for it own use and for
supply to Third Parties for that same
period; provided that if this Agreement has not been in effect for a full twelve
(12) month period, then such shorter period shall be used in lieu of a twelve (12) month period.
ARTICLE XIII
NOTICES
NOTICES
13.1 Ordinary Notices. Correspondence, reports, documentation, and any other
communication in writing between the Parties in the course of ordinary implementation of this
Agreement shall be delivered by hand, sent by facsimile or overnight courier to the employee or
representative of the other Party who is designated by such other Party to receive such written
communication at the address or facsimile numbers specified by such employee or representative.
13.2 Extraordinary Notices. Extraordinary notices and communications (including
without limitation, notices of termination, force majeure, material breach, change of address,
requests for disclosure of Confidential Information, claims or indemnification) shall be in writing
and sent to each Party by prepaid registered or certified airmail, or by facsimile confirmed by
prepaid registered or certified airmail letter (and shall be deemed to have been properly served to
the addressee upon receipt of such written communication) to the address set forth in Section 13.3
or such other address as notified in writing by such Party to the other Party.
13.3 Addresses.
If to WCH:
Wyeth Consumer Healthcare
Five Giralda Farms
Madison, New Jersey 07940
Attention: President
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
Five Giralda Farms
Madison, New Jersey 07940
Attention: President
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
With a copy to:
Wyeth
Five Giralda Farms
Madison, New Jersey 07940
Attention: General Counsel
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
Five Giralda Farms
Madison, New Jersey 07940
Attention: General Counsel
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
If to IMPAX:
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Impax Laboratories, Inc.
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Co-Chief Executive Officer
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Co-Chief Executive Officer
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
With a copy to:
▇▇▇ ▇▇▇▇▇▇▇, Esq.
Blank, Rome, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇ LLP
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
Blank, Rome, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇ LLP
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Facsimile No.: ▇▇▇-▇▇▇-▇▇▇▇
ARTICLE XIV
MISCELLANEOUS
MISCELLANEOUS
14.1 Governing Law. This Agreement shall be construed in accordance with and governed
by the law of the State of New York, without giving effect to its conflict of laws provisions.
14.2 Equal Opportunity Clause. The Equal Opportunity Clause required by Executive
Orders 11246, as amended (41-CFR 60-1.4) and 11375, the Employment Assistance to Veterans Clause
required by Executive Order 11701 (41 CFR 60-250.4), the Vietnam Era Veteran Readjustment Act of
1972, the Employment of the Handicapped Clause required by the Rehabilitation Act of 1973 (41 CFR
60-741.4) and the Americans with Disabilities Act of 1991 are part of this Agreement and binding
upon each Party unless exempted by rules, regulations or orders of the Secretary of Labor. IMPAX
agrees that the applicable clause with regard to the utilization of minority contractors set forth
at 41 CFR 1-1.303 and the applicable clause with regard to the Utilization of Small Business
Concerns and Small Business Concerns Owned and Controlled by Socially and Economically
Disadvantaged Individuals set forth at 41 CFR 1-1.13 are incorporated herein by reference, as
applicable. IMPAX agrees to provide information and documentation with respect to the foregoing to
WCH upon request.
14.3 Assignment. This Agreement shall not be assignable or transferable by either
Party hereto without the prior written consent of the other Party, except that either Party may
assign this Agreement without the other Party’s consent to the successor or the transferee of all,
or substantially all, of the Products, assets or business to which this Agreement relates or to one
of its Affiliates; provided that if IMPAX is the assigning Party, IMPAX also
transfers the Facility to such assignee. IMPAX shall not subcontract any of its work hereunder
without WCH’s prior written consent and any such consent given by WCH shall not release IMPAX from
its obligations hereunder. WCH’s sublicensing of its obligations under this Agreement shall not
release WCH from its obligations hereunder. This Agreement shall be binding upon and shall inure
to the benefit of the Parties and their successors and permitted assigns.
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14.4 Entire Agreement. This Agreement and all Exhibits attached hereto (as the same
may be amended from time to time by the written agreement of the Parties) constitute the entire
agreement between the Parties with respect to the subject matter hereof and supersedes all other
documents, agreements, verbal consents, arrangements and understandings between the Parties with
respect to the subject matter hereof. This Agreement shall not be amended orally, but only by an
agreement in writing, signed by both Parties that states that it is an amendment to this Agreement.
14.5 Severability. If any term of this Agreement shall be found to be invalid,
illegal or unenforceable, it is the intention of the parties that the remainder of this Agreement
shall not be affected thereby; provided that neither Party’s rights under this
Agreement are materially adversely affected.
14.6 Independent Contractor. IMPAX shall act as an independent contractor and neither
Party shall have any authority to represent or bind the other Party in any way.
14.7 No Waiver. Any waiver by one Party of any right or such Party or obligation of
the other Party must be in writing signed by the Party waiving such right or performance of such
obligation and shall not operate as a waiver of any subsequent right or obligation.
14.8 Counterparts. This Agreement may be executed in two or more counterparts, each
of which shall be an original and all of which together shall constitute one and the same
Agreement.
14.9 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 and any such delay shall not constitute a force
majeure event or constitute a breach of this Agreement. 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 United States Department of Commerce, FDA and/or any other agency or department of
the United States Government as required.
14.10 HSR Filing. To the extent necessary, each of IMPAX and WCH shall file as soon
as practicable after the date this Agreement was signed by each of the Parties, with the Federal
Trade Commission (the “FTC”) and the Antitrust Division of the United States Department of Justice
(the “Antitrust Division”) the notification and report form (the “Report”) required under the
▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Antitrust Improvements Act of 1976, as amended, and the rules and regulations
promulgated thereunder (“HSR Act”) with respect to the transactions as contemplated hereby and
shall reasonably cooperate with the other Party to the extent necessary to assist the other Party
in the preparation of its Report and to proceed to obtain necessary approvals under the HSR Act,
including but not limited to the expiration or earlier termination of any and all applicable
waiting periods required by the HSR Act. Each Party shall bear its own expenses, including,
without limitation, legal fees, incurred in connection with preparing such
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filings. If a Report is
filed by the Parties under the HSR Act, then the Effective Date shall be the date upon which the
necessary approvals have been obtained under the HSR Act or that the notice and waiting period
under the HSR Act has expired or been terminated.
If the Parties determine that no Report is required to be filed under the HSR Act, the
Effective Date shall be the date first written above.
In the event that a Report is required to be filed under the HSR Act, either Party may, prior
to the Effective Date, terminate this Agreement by written notice to the other Party, if, within
one hundred twenty (120) days after this Agreement is signed by each of the Parties, approval of
the transactions contemplated by this Agreement under the HSR Act has not been obtained or the
notice and waiting period, as may be extended by the FTC, under the HSR Act has not expired without
adverse action regarding this Agreement or the transactions contemplated hereby. If this Agreement
is terminated pursuant to this Section 14.10, then, notwithstanding any provision in this Agreement
to the contrary, neither Party shall have any further obligation to the other Party with respect to
the subject matter of this Agreement except for the obligations set forth in Article X hereof,
which obligations shall survive any termination of this Agreement.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
| WYETH, acting through its Wyeth Consumer Healthcare Division |
||||
| By: | /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ | |||
| Name: | ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ | |||
| Title: | Vice President of Global Business Development | |||
| IMPAX LABORATORIES, INC. |
||||
| By: | /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ | |||
| Name: | ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ | |||
| Title: | Co-Chief Executive Officer | |||
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