EXHIBIT 10.14
SUPPLY AND MANUFACTURING AGREEMENT
Between
TEIKOKU SEIYAKU CO., LTD./TEIKOKU PHARMA USA, INC.
And
ENDO PHARMACEUTICALS INC.
The confidential portions of this exhibit have been filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request
in accordance with Rule 406 of the Securities Act of 1933.
REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***.
TEIKOKU-ENDO
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This Supply and Manufacturing Agreement, is effective as of the 23rd day of
November 1998, between Teikoku Seiyaku Co., Ltd., a Japanese corporation
(TEIKOKU JAPAN) and its U.S. subsidiary, Teikoku Pharma USA, Inc. (TEIKOKU USA)
having their respective principal office at 567 Sanbonmatsu, Ochio-cho,
Ohkawagun, ▇▇▇▇▇▇ ▇▇▇-▇▇, ▇▇▇▇▇ and Suite 101, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇
▇▇▇▇▇-▇▇▇▇ (collectively hereinafter referred to as "TEIKOKU"), and Endo
Pharmaceuticals Inc., a Delaware corporation, having its principal office at ▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇ ("ENDO").
WHEREAS, ENDO has entered into an Sole and Exclusive License Agreement of even
date with Hind Health Care, Inc. (HIND), pursuant to which ENDO has obtained a
sole and exclusive license to all of HIND's Intellectual Property with regards
to a topical formulation of lidocaine for the treatment of post-herpetic
neuralgia, other forms of neuralgia and other neuropathy (Product);
WHEREAS, HIND and TEIKOKU have represented to ENDO that under a separate
agreement between them, TEIKOKU USA will become the owner of the NDA for the
Product upon the issuance of such NDA by the FDA and is listed in the NDA as the
sole manufacturer of the Product;
WHEREAS, TEIKOKU JAPAN has represented to ENDO that it has and will make
available suitable facilities, equipment, and sufficiently trained and qualified
employees at its facilities to manufacture and supply ENDO with the Product; and
WHEREAS, ENDO upon reliance on these various representations by HIND and TEIKOKU
desires to avail itself of the services of TEIKOKU and TEIKOKU is willing to
provide its services to manufacture and supply the Product to ENDO under the
terms and conditions set forth below;
NOW, THEREFORE, in consideration of the covenants and obligations hereinafter
set forth and intending to be legally bound, the parties hereby agree as
follows:
1. DEFINITIONS
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1.1 "Adverse Reaction" means all data concerning any serious or unexpected
adverse effects, side-effects, and contraindications of the Product which
may come to the attention of either of the parties, and which, in the
reasonable judgment of such party is of such a nature and magnitude that it
is required under the laws of the United States or Japan to be collected,
maintained, and reported to a Competent Regulatory Authority.
1.2 "Affiliate" means any entity controlling, controlled by or under common
control of either ENDO or TEIKOKU JAPAN. For purposes hereof, "control"
shall mean ownership, directly or indirectly, of more than fifty percent
(50%) of the securities having the right to vote for the election of
directors, in the case of a corporation, and more than fifty percent (50%)
of the beneficial interest in the capital, in the case of a business entity
other than a corporation.
1.3 "Best Efforts" means those efforts which would be made by a reasonably
prudent business person acting in good faith, in the exercise of reasonable
commercial judgment and in a manner consistent with those efforts a party
devotes to a pharmaceutical product resulting from its own research efforts
and having similar market potential.
1.4 "Commercial Package" means a sealed carton which contains six (6) Envelopes
and shall constitute the final finished package configuration ready for
importation to the United States for commercial sale by ENDO in the United
States as modified from time to time by mutual consent of the parties.
1.5 "Competent Regulatory Authority" means the FDA in the United States, the
MOHW in Japan, or any other government agency responsible for the issuance
of any authorizations, registrations, licenses, or approvals for
pharmaceutical products to be manufactured in and exported from Japan and
imported into the United States for commercial sale in the United States.
1.6 "Envelope" means a hermetically sealed, resealable, four (4) colors (white,
being considered a color) pre-printed envelop which contains five (5)
Products.
1.7 "FDA" means the United States Food and Drug Administration.
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1.8 "Good Manufacturing Practices" means those practices in the manufacture of
pharmaceutical products which are recognized as good manufacturing
practices by the FDA in accordance with FDA guidelines, other
administrative interpretations, and rulings in connection therewith,
including but not limited to those regulations cited in 21 CFR parts 210
and 211.
1.9 "Intellectual Property Rights" means the Patents and Know-How listed in
Exhibit A which are necessary or useful for the manufacture, export, and
import of the Product.
1.10 "Know-how" means all information and data, regardless of form, which is
necessary or useful for the manufacture, export, and import of the Product
including, but not limited to, the chemical composition, manufacturing
processes, procedures, methods, analytical tests, and quality control
information for the Product.
1.11 "Label" means any written, printed, or graphic matter upon the Product, the
Envelope, the Commercial Package, or the Sample.
1.12 "Manufacture" means the making, finishing, packaging, and/or labeling of
the Product and the Commercial Package.
1.13 "NDA" means the new drug application covering the Product on file with the
FDA, as amended from time to time.
1.14 "Patent" means the United States patents and patent applications listed in
Exhibit A owned in whole or in part or licensed or assigned to TEIKOKU and
all reissues, extensions, substitutions, confirmations, registrations,
revalidations, additions, continuations, continuations-in-part, and
divisions thereof.
1.15 "MOHW" means the Japanese Ministry of Health and Welfare.
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1.16 "Product" means the transdermal (Patch) delivery system, which consists of
a topical formulation of Lidocaine, designated as formula number KN48.
1.17 "Product Launch" means the first commercial sale of the Product by ENDO for
resale or use to an unaffiliated third party in the Territory.
1.18 "Related Agreement" means the Sole and Exclusive License Agreement entered
into by Hind Health Care, Inc. and ENDO of even date herewith and attached
hereto as Exhibit B and made a part hereof.
1.19 "Sample" means two (2) Products in an Envelop which is not intended to be
sold for commercial value by ENDO in the Territory.
1.20 "Submission Package" means all pre-clinical, laboratory, clinical,
biocompatibility and other testing data, labeling, processing, material and
packaging specifications, and supplements or amendments to the foregoing;
and all other information in the possession of and used by TEIKOKU and HIND
for submitting, obtaining, and maintaining approval of a NDA in accordance
with the requirements of the Food Drug & Cosmetic Act, as amended, from
time to time.
1.21 "Territory" means the United States, its territories, commonwealths, and
possessions.
1.22 "Yen" means the legal currency and tender of Japan.
Except as otherwise defined above, all capitalized terms used in this Agreement
shall have the respective meanings attached to them as set forth in the Related
Agreement.
2. OBLIGATIONS OF THE PARTIES
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2.1 MANUFACTURING
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(1) TEIKOKU-During the term of this Agreement, TEIKOKU JAPAN shall be
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responsible for the following activities in connection with the manufacture
of the Product:
(1) TEIKOKU JAPAN shall use its Best Efforts to Manufacture the
Product in compliance with current Good Manufacturing Practices
("GMP") as applied to final finished pharmaceutical products as
regulated by the FDA, in accordance with all TEIKOKU JAPAN'S
standard operating procedures, and in accordance with ENDO's
quality control requirements. A list of TEIKOKU JAPAN's standard
operating procedures for the manufacture of the Product and
ENDO's quality control requirements are attached hereto as
Exhibits C and D, respectively.
(2) TEIKOKU JAPAN shall validate its pharmaceutical manufacturing
processes, tests, and methods as well as associated facilities,
equipment and systems, keep such processes, tests, methods,
facilities, equipment, and systems current, and make results of
validation and annual reviews of such processes, tests, methods,
facilities, equipment, and systems available to ENDO within sixty
(60) calendar days of Endo's reasonable request for such
information;
(3) TEIKOKU shall retain such samples of the Product as are required
and specified to comply with the general retention requirements
as set forth in GMPs, perform stability testing as described and
required to conform with the Product stability protocol and
report any confirmed out-of-specification test results to ENDO
within ten (10) business days, and make Product stability reports
and findings available for inspection by ENDO within ten (10)
business days of ENDO's reasonable request for such information;
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(4) The parties agree that any changes in TEIKOKU JAPAN's testing or
packaging procedures for the Product outside the approved
documented process will require prior written mutual consent of
the parties. Should ENDO request a change (or changes) in
specifications, manufacturing process, materials, analytical
testing methods mandated by the FDA or any other Competent
Regulatory Authority, or request a change not mandated by the
FDA, TEIKOKU JAPAN, in conformity with regulations governing such
change, shall make every reason able effort to accommodate such a
change (or changes), but all reasonable cost incidental to such a
change that was not man dated by the FDA or any other Competent
Regulatory Authority shall be borne by ENDO;
(5) TEIKOKU JAPAN shall maintain its manufacturing facility in
compliance with FDA regulations and update all required
documentation in cooperation with ENDO in the event of any
amendments that may be made to the NDA.
(6) TEIKOKU JAPAN shall investigate all abnormalities in processing
of the Product and share all investigation reports with ENDO
(7) TEIKOKU shall participate and cooperate with ENDO representatives
who may audit TEIKOKU's facilities and records related to the
manufacture of the Product and implement the recommendations, if
any, made by ENDO as a result of such audit, as may be required
to comply with this Agreement. TEIKOKU will provide ENDO with a
written action planned for the implementation of such
recommendations or the actions already taken by TEIKOKU with
regard to such recommendations;
(8) Assure that penicillin, cephalosporin or penicillin and
cephalosporin-containing products will not be received, stored,
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handled, dispensed, Manufactured or packaged in the same
facility(ies) or in facilities that share common Heating,
Ventilation and Air Conditioning systems or utilize the same
equipment in the manufacture or handling of the components, raw
materials or packaging of the Product;
(9) retain all records of the processing and manufacture of the
Product in accordance with the applicable regulatory
requirements.
(2) During the term of this Agreement, ENDO shall be responsible for the
following activities in connection with the manufacture of the Product:
(1) ENDO shall periodically audit, at reasonable intervals, TEIKOKU
JAPAN's facilities and the Product and Commercial Package-
related regulatory records upon the provision of advance notice
to TEIKOKU JAPAN. ENDO shall promptly provide TEIKOKU a copy of
ENDO's audit report and/or any observations ENDO may have as a
result of its audit.
2.2 SUPPLY OF THE PRODUCT
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(1) TEIKOKU USA hereby grants to ENDO a Sole and Exclusive license under
the NDA to use, market and sell Product purchased by ENDO from TEIKOKU USA.
(2) Quantities.
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(1) ENDO Product Requirements. TEIKOKU USA shall supply and sell to
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ENDO and ENDO agrees to purchase, one hundred percent (100%) of
ENDO's requirements for Commercial quantities and Samples of the
Product for the Territory in accordance with this Agreement and
the terms, if any, set forth in ENDO's purchase orders. If a
conflict between ENDO's
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purchase order and the terms of this Agreement exists or
develops, the terms of this Agreement shall prevail.
(2) Annual Minimum Orders. ENDO shall purchase from TEIKOKU USA and
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TEIKOKU USA shall supply annual minimum orders in the amount set
forth in Exhibit E attached hereto and made a part hereof, as
amended from time to time through mutual consent of the parties.
(3) Product Estimates. Within thirty (30) days of execution of this
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Agreement, ENDO shall provide TEIKOKU USA an estimate of its
requirements for the Product by month for the calendar year 1999.
Thereafter, ninety (90) days prior to the beginning of each
calendar quarter, ENDO shall provide to TEIKOKU USA an estimate
of its requirements for the Product by month for the upcoming
four (4) calendar quarters. These estimates for the Product
shall be estimates only and shall not constitute binding
commitments for the Product.
(4) Product Firm Orders. At least one hundred fifty (150) days prior
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to the beginning of a calendar quarter, ENDO will provide
TEIKOKU with a firm order for the Product for said calendar
quarter ("Firm Order"). Firm Orders for the Product for the
applicable calendar quarter may not be less than 75% nor greater
than 135% of the estimates for such calendar quarter provided in
Paragraph 2.2(b) above. TEIKOKU shall be required to supply to
ENDO such Firm Orders of Product for the applicable calendar
quarter.
(5) Material Change in Product and/or Label. Notwithstanding
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Paragraph 2.2(iii) above, in the event that ENDO requires TEIKOKU
to materially change the Commercial Package Label, at least one
hundred and fifty (150) days prior to the beginning of a calendar
quarter, ENDO will provide TEIKOKU with a Firm Order for the
Product with the revised
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Label for said calendar quarter. Firm Orders for the Product with
the revised Label for the applicable calendar quarter may not be
less than 75% nor greater than 135% of the estimates for such
calendar quarter provided in Paragraph 2.2(ii) above. TEIKOKU
shall use its best commercial efforts to supply to ENDO such Firm
Orders of Product for the applicable calendar quarter.
The parties shall work together in good faith to ensure the
fastest implementation of the manufacture and delivery of any
material change required to the Product.
(6) Minimum Shelf Life. TEIKOKU hereby warrants that at the time of
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delivery of Product to ENDO under this Agreement, such Product
shall have a minimum of eighty percent (80%) of its shelf life
still available.
2.3 REGULATORY MATTERS
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(1) FDA Communications. Upon being contacted by the FDA for any regulatory
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purpose related to the Product or the NDA for the Product, TEIKOKU
shall immediately notify ENDO. ENDO shall be responsible for providing
all responses directly to the FDA regarding inquiries related to the
marketing, promotion, and/or sale of the Product, including any
amendments or supplements to the NDA for the Product relating to its
marketing, promotion and/or sale within the Territory and ENDO shall
copy TEIKOKU USA with all such responses. TEIKOKU shall be responsible
for providing all responses directly to the FDA regarding inquiries
related to the manufacture, export, or import of the Product and
TEIKOKU USA shall copy ENDO with all such responses.
(2) Regulatory Approvals.
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(1) Submission Package. TEIKOKU USA shall submit all applications,
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including any Submission Packages, to obtain the
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necessary authorizations, licenses, registrations, or approvals
to manufacture, export, and import the Product for sale in the
Territory.
(2) Expenses. TEIKOKU shall bear all its own costs and expenses to
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obtain any necessary authorizations, licenses, registrations, or
approvals to manufacture, export, and import the Product for sale
in the Territory.
(3) Adverse Drug Reactions/Product Complaints
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(1) Adverse Reaction or Product Complaint: Each party hereto hereby
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agrees to notify the other parties by facsimile with a follow up
hard copy, within twenty-four hours (24) of receipt of any
adverse reaction or complaint reported to it or its agent
resulting from the use of the Product.
(2) FDA Reporting.
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(1) Adverse Reactions and Field Alerts: TEIKOKU USA will be
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responsible for completion and submission to the FDA of any
Form FDA 3500a with respect to an adverse reaction involving
the Product or any complaint that would require a field
alert, as and when appropriate, unless such request is made
directly to ENDO or ENDO is under any statutory or
regulatory obligation to make such or similar report or
filing. Each party will forward to the other a copy of each
completed Form FDA 3500a or similar report or filing with
respect to the Product at least forty-eight (48) hours prior
to filing such a report with the FDA.
(2) Periodic Adverse Experiences Reports and Annual Reports:
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TEIKOKU USA will be responsible for completion of the
periodic ADE (Adverse Drug Experiences)
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reports and annual reports required by the FDA with
respect to the Product. TEIKOKU USA will forward to ENDO a
copy of each such report dealing with the Product at least
forty-eight (48) hours before filing such with the FDA.
(3) Recalls. TEIKOKU shall inform ENDO of any withdrawal,
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recall actions or FDA audit of its manufacturing facilities
and the Product process and provide copies to ENDO of all
inspection observations reports (483s) and any other FDA or
other Competent Regulatory Authority communications and
TEIKOKU's responses to such communications which may affect
the manufacture, export, or import of the Product or
TEIKOKU's facility's compliance with GMPs;
2.4 PAYMENTS
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(1) ENDO agrees to pay to TEIKOKU USA the prices set forth in Exhibit E
attached hereto and made a part hereof with regards to Products supplied to
ENDO by TEIKOKU under this Agreement.
(2) Payments due from ENDO hereunder to TEIKOKU USA shall be made via a
Letter of Credit, issued from a reputable bank on terms that are
reasonably acceptable to TEIKOKU USA and shall be paid thirty (30) days
after receipt by the issuing bank of all documents necessary for payment
under the Letter of Credit, provided that ENDO shall promptly deliver to
TEIKOKU USA all documents required to be delivered by ENDO under the Letter
of Credit.
2.5 PRODUCT SHIPMENTS
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TEIKOKU JAPAN shall properly prepare and package the Product and the Commercial
Package so that it may be lawfully and safely shipped to points designated by
ENDO in the Territory. Further, to the extent requested by ENDO or as required
by
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applicable law or custom, for each shipment of Product, TEIKOKU shall prepare
and execute all necessary or applicable shipping documents; including a
Certificate of Analysis for each lot and include such documents with each
shipment. Terms of shipment will be FOB delivered to ENDO's Atlanta, Georgia
Distribution Center site, duty paid, or such other site as may be mutually
agreed upon by the parties hereto. ENDO shall inspect all such shipments upon
their receipt and shall report any readily discernible defects to TEIKOKU USA
within sixty (60) days of receipt of the shipment of Product. ENDO will report
any defects not readily discernible to TEIKOKU USA within thirty (30) days of
ENDO's discovery of same. ENDO shall not be deemed to have finally accepted the
Product shipment until completion of ENDO's review of all relevant documentation
related to the shipment of the Product and/or retesting of the Product.
3. OPTION TO QUALIFY AN ADDITIONAL MANUFACTURING SITE
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During the term of this Agreement, in the event ENDO's purchase of Product from
TEIKOKU equals *** or greater Envelopes in *** consecutive calendar years
commencing from the Launch of the Product by ENDO, TEIKOKU shall use its best
commercial efforts, at ENDO's request, to qualify in the shortest possible time,
a second fully operational, FDA-approved, manufacturing facility at a different
factory site in Japan to manufacture one hundred (100%) percent of ENDO's annual
requirements for the Product in the Territory. Such facility shall comply with
GMP requirements and all other applicable FDA regulations governing the
manufacture and importation of the Product into the Territory, provided that
ENDO shall pay fifty percent of TEIKOKU's reasonable cost to create and/or
qualify such second manufacturing facility and such payment by ENDO shall, in no
event, exceed ***.
4. ADDITIONAL TERRITORIES
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4.1 In the event ENDO exercises its option for a license to market, promote,
and sell the Product in *** and *** under the Related Agreement, TEIKOKU
hereby agrees to supply and ENDO hereby agrees to purchase, one hundred
(100%) of ENDO's annual requirements for the Product for commercial sale of
the Product in *** and *** on commercial terms
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substantially similar to the terms contained in this Agreement, which terms
shall be mutually agreed to by the parties.
4.2 In the event ENDO exercises its option for a license to market, promote,
and sell the Product in *** and *** under the Related Agreement, TEIKOKU
shall provide reasonable assistance to ENDO, at ENDO's expense, to obtain
all necessary authorizations, licenses, registrations, or approvals for
ENDO to market, promote, sell, and distribute the Product in *** and ***.
5. WARRANTIES AND REPRESENTATIONS
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5.1 Legal Authority. Each party represents and warrants to the other that it
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has the legal power, authority and right to enter into this Agreement and
to perform its respective obligations set forth herein.
5.2 No Conflicts. Each party represents and warrants that as of the date of
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this Agreement it is not a party to any agreement or arrangement with any
third party or under any obligation or restrictions, which in any way
limits or conflicts with its ability to fulfill any of its obligations
under this Agreement.
5.3 Third Party Claims. TEIKOKU warrants to ENDO that there are no third party
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claims that would challenge or impair the license of the rights granted to
ENDO herein, including without limitation, any claims based upon patents,
copyrights, trademarks, or trade secret laws of the Territory.
5.4 Submission Package. TEIKOKU hereby warrants and represents to ENDO that
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the TEIKOKU's section of the Submission Package (CMC Section) for the
Product and all information contained therein, as of the effective date of
this Agreement, are true and correct and that TEIKOKU is unaware of any
fact that would render such information inaccurate or untrue.
5.5 Survival. The foregoing representations and warranties shall survive the
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execution, delivery, and performance of this Agreement, notwithstanding any
due diligence investigation by or on behalf of either party.
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6. TERM
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This Agreement shall begin on the day written above and shall expire upon
expiration of the Related Agreement.
7. TERMINATION
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This Agreement may be terminated by either TEIKOKU or ENDO for the following
reasons:
(a) Material Breach. Either party may terminate this Agreement in the
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case of a material breach by one of the other parties which is not cured
within forty five (45) days after written notice of the breach by the
terminating party
(b) Bankruptcy. Either party may terminate this Agreement immediately in
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its entirety if the other party is declared insolvent by a court of
competent jurisdiction, files a petition of bankruptcy, is adjudged
bankrupt, takes advantage of any insolvency act, is in receivership, or
executes a ▇▇▇▇ of sale, deed of trust, or assignment for the benefit of
creditors.
(c) ENDO may terminate this Agreement immediately upon termination of the
Related Agreement.
8. EFFECT OF TERMINATION
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Upon termination of this Agreement by ENDO in accordance with Paragraph 7(a)
above, ENDO shall have the right to make or have made the Product for commercial
sale in the Territory. TEIKOKU shall be required to negotiate in good faith, a
reasonable royalty-bearing sublicensable license to TEIKOKU's Intellectual
Property Rights to make and have made the Product solely in the Territory.
9. EFFECT OF TERMINATION ON OTHER OBLIGATIONS
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Termination of this Agreement shall have no effect on, or relieve any party from
the obligation to make any payment or perform any actions arising prior to the
effective date of termination. Further, any rights and obligations of the
parties, which by their intent are meant to survive the termination or
expiration of this Agreement, shall survive the expiration or termination of
this Agreement.
10. INDEMNIFICATION
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10.1 TEIKOKU shall indemnify, defend, and hold harmless ENDO, its officers,
agents, Affiliates, subsidiaries, parent companies, and employees, from and
against any and all loss, damage, claim, injury, cost or expenses,
including reasonable attorneys' fees and expenses of litigation, in
connection with any illness or personal injury, including death, or
property damage, that arises out of or is attributable to: (1) any
negligent act or willful misconduct of TEIKOKU with respect to the
manufacture, supply, export, or import of the Product in the Territory; (2)
latent defects in the Product or any component of the Product; or (3)
TEIKOKU's breach of the terms of this Agreement, provided, however, TEIKOKU
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shall not be obligated to indemnify ENDO to the extent that any loss,
damage, claim, injury, cost or expense arises out of ENDO's negligence,
willful misconduct or breach of this Agreement.
10.2 TEIKOKU USA shall defend, indemnify and hold harmless ENDO and its
officers, agents, affiliates, subsidiaries, parent companies, and
employees, from and against any and all loss, claim, injury, damage, cost
or expense, including reasonable attorneys' fees and expenses of
litigation, in connection with any claimed infringement of any third party
patent rights under the patent laws of Japan and the United States with
respect to the manufacture, supply, export, and import of the Product
hereunder.
10.3 ENDO shall indemnify, defend, and hold harmless TEIKOKU, its officers,
agents, Affiliates, subsidiaries, parent companies, and employees, from and
against any and all loss, damage, claim, injury, cost or expense, including
reasonable attorneys' fees and expenses of litigation, in connection with
any illness or personal injury, including death, or property damage, that
arises out of: (1) any use, marketing, promotion, sale, or distribution of
the Product in
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the Territory; (2) the negligence or willful misconduct of ENDO; or (3)
breach of the terms of this Agreement by ENDO, provided, however, ENDO
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shall not be obligated to indemnify TEIKOKU to the extent that any loss,
damage, claim, injury, cost or expense arises out of TEIKOKU 's negligence,
willful misconduct, latent Product defects, or breach of this Agreement.
11. CONFIDENTIALITY
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11.1 All information disclosed by one party to the other under this Agreement
shall be deemed to be confidential information ("Confidential
Information"). The parties hereby agree to hold in strictest confidence any
and all Confidential Information disclosed by one party to the other under
this Agreement or obtained by either party as a result of performing its
obligations under this Agreement. The parties hereby agree that the
following shall not be considered Confidential Information subject to this
Agreement:
(1) information which at the time of disclosure by one party to the other
is in the public domain;
(2) information which, after disclosure by one party to the other becomes
part of the public domain by publication or otherwise, provided that such
publication is not in violation of this Agreement or any other
confidentiality agreement;
(3) information, which the receiving party can establish in writing, was
already known to it or was in its possession at the time of disclosure by
the other party and was not acquired, directly or indirectly, from the
disclosing party.
(4) information, which the receiving party lawfully receives from a third
party, provided, however, that such third party was not obligated to hold
such information in confidence.
(5) information which the receiving party is compelled to disclose by a
court or other tribunal of competent jurisdiction, or the FDA, provided
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however, that in such case the receiving party shall immediately give
notice to the disclosing party to enable the disclosing party to exercise
its legal rights to prevent and/or limit such disclosure. In any event,
the receiving party shall disclose only that portion of the Confidential
Information that, in the opinion of the disclosing party's legal counsel,
is legally required to be disclosed and will exercise reasonable efforts to
ensure that any such information so disclosed will be accorded confidential
treatment by said court or tribunal.
11.2 The receiving party shall not use Confidential Information for any purpose
other than for the purposes set forth in this Agreement.
11.3 The receiving party will not disclose Confidential Information to any
person other than to its employees, officers, agents, and consultants that
have a need to know such information to effectuate the purpose of this
Agreement and that such employees, officers, agents, and consultants shall
be informed of this Confidentiality Agreement and shall, in writing, be
bound by its terms. All Confidential Information will contain a statement
indicating that the information is confidential and should not be disclosed
to unauthorized individuals.
11.4 Upon written request from the disclosing party or termination of this
Agreement, whichever comes sooner, the receiving party shall either
promptly return to the disclosing party all Confidential Information
provided to the receiving party pursuant to this Agreement including any
copies thereof and notes or extracts based thereon or certify to the
disclosing party that all such Confidential Information have been duly
destroyed; except the receiving party may keep one (1) copy for archival
purposes and until this Agreement is terminated or becomes inoperative,
shall keep confidential and not use in any way detrimental to the
disclosing party any analyses, compilation, studies or other documents
which reflect any of the Confidential Information.
12. APPLICABLE LAW
--------------
TEIKOKU-ENDO
SUPPLY & MANUFACTURING AGREEMENT
PAGE 19
The laws of the Commonwealth of Pennsylvania, U.S.A., shall govern the
construction of this Agreement, not taking into consideration its conflicts of
laws provisions.
13. FORCE MAJEURE
-------------
No party shall be liable for a delay in performance or failure to perform an
obligation under this Agreement if such delay or failure is due to an act of God
or any other occurrence beyond the control of the party, including but not
limited to fire, explosion, disease, war, invasion, government acts, weather or
civic unrest, or strikes, provided, however, that the party who is unable to
perform its obligations under this Agreement due to such occurrence resumes its
performance as soon as possible following the end of the occurrence causing
delay or failure. If for any reason, including Force Majeure, TEIKOKU's
capability to manufacture and deliver the Product under this Agreement is
impaired, TEIKOKU will give ENDO first preference in allocation of available
supply of Product. In the event that a party claims non performance of its
obligations under this Agreement as a result of this Paragraph, the other party
shall have the right to terminate this Agreement if the force majeure that is
claimed results in non performance by the claiming party that last more than
ninety (90) days.
14. RECORDS AND INSPECTION
----------------------
TEIKOKU shall permit the duly authorized representatives of ENDO to visit and
inspect the Manufacturing (including waste handling and disposal), processing
testing, packing, and shipping facilities for the Product during normal business
hours provided, however, that ENDO shall first provide TEIKOKU with reasonable
notice of any such intended visit. Further, ENDO shall, after providing the
same amount of prior notice to TEIKOKU, be provided with access to audit any and
all documents and records related directly with (1) TEIKOKU's manufacture and
supply of the Product, and (2) TEIKOKU's performance under this Agreement with
respect to the manufacture and supply of the Product. Further, TEIKOKU shall
permit representatives of the FDA or their agents to visit and inspect any and
all facilities used in the manufacturing, testing, processing, packaging, or
shipping of the Product. This permission for both the FDA and ENDO shall
include access to audit any and all documents and records relating to TEIKOKU's
performance under this Agreement.
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SUPPLY & MANUFACTURING AGREEMENT
PAGE 20
15. RETENTION OF RECORDS
--------------------
Whenever applicable, all documentation, records, raw data, and specimens
pertaining to this Agreement will be held for the length of time specified by
the FDA GMP regulations.
16. ARBITRATION
-----------
16.1 All disputes over the meaning and interpretation of this Agreement shall be
resolved by conciliation and non-binding mediation and if such mediation is
unsuccessful then such disputes shall be finally settled by a single
Arbitrator selected by TEIKOKU and ENDO. If TEIKOKU and ENDO cannot agree
on a single Arbitrator, then disputes shall be resolved by an Arbitration
Panel comprising one arbitrator appointed by TEIKOKU and one arbitrator
appointed by ENDO, and a Chairman of the Arbitration Panel appointed by the
first two arbitrators. Any such arbitration proceeding shall be conducted
in accordance with AAA rules; shall be held in the Commonwealth of
Pennsylvania, unless otherwise agreed by the parties; and judgment upon the
arbitration award may be entered in any court having jurisdiction.
16.2 In order to initiate procedures for dispute resolution by conciliation,
mediation and arbitration either party may give written notice to the
other of intention to resolve a dispute, and absent satisfactory
resolution, then to arbitrate. Such notice shall contain a statement
setting forth the nature of the dispute and the resolution sought. If,
within thirty (30) days of such notice a resolution by conciliation between
the parties themselves or by mediation has not been achieved to the
satisfaction of both parties, and if within sixty (60) days from said
written notice an Arbitrator or Arbitration Panel has not been appointed
with an arbitration schedule satisfactory to both parties, then either
party may proceed with judicial remedies.
16.3 Notwithstanding the above, TEIKOKU reserves the right and power to proceed
with direct judicial remedies against ENDO without conciliation, mediation
or arbitration for material breach of the payments due on Products
TEIKOKU-ENDO
SUPPLY & MANUFACTURING AGREEMENT
PAGE 21
supplied to ENDO by TEIKOKU under this Agreement after giving written
notice of such breach to ENDO followed by an opportunity period of forty
five (45) days in which to cure such breach. In collecting overdue payments
TEIKOKU may use all judicial remedies available.
17. NOTICES
-------
All notices required under this Agreement shall be in writing and shall be
effective if delivered to the party entitled to receive the same by hand or when
received by the addressee if such notice is deposited in the United States or
Japanese Mail addressed to such party at the address set forth below.
If to TEIKOKU:
--------------
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
President & CEO
Teikoku Pharma USA, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇,
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Tel: ▇▇▇-▇▇▇-▇▇▇▇
Fax: ▇▇▇-▇▇▇-▇▇▇▇
With a copy to:
▇▇▇▇▇ ▇▇▇▇▇
Manager, International Division,
Teikoku Seiyaku Co., Ltd.
567 Sanbonmatsu, ▇▇▇▇-▇▇▇,
Ohkawa-gun, ▇▇▇▇▇▇ ▇▇▇-▇▇,
▇▇▇▇▇
Tel: ▇▇▇-▇▇-▇▇▇-▇▇-▇▇▇▇
Fax: ▇▇▇-▇▇-▇▇▇-▇▇-▇▇▇▇
and if to ENDO:
TEIKOKU-ENDO
SUPPLY & MANUFACTURING AGREEMENT
PAGE 22
▇▇▇▇▇ ▇. ▇▇▇▇▇
President & CEO
Endo Pharmaceuticals Inc.
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
With a copy to:
Osagie 0. Imasogie
Senior Vice President, Business Development
Endo Pharmaceuticals Inc.
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
18. ASSIGNMENT
----------
This Agreement shall be binding upon and inure to the benefit of the parties
hereto and their respective successors and assigns, provided that neither party
shall assign this Agreement or any rights herein without the other party's
consent, except that ENDO may assign this Agreement to its successor in business
and/or parent entity.
19. HEADINGS
--------
All headings of the clauses of this Agreement are inserted for convenience only
and shall not affect any construction or interpretations of this Agreement.
20. PRESERVATION OF RIGHTS
----------------------
The waiver of a default of any clause of this Agreement shall not be construed
as a waiver of either subsequent or continuing default.
TEIKOKU-ENDO
SUPPLY & MANUFACTURING AGREEMENT
PAGE 23
21. SEVERABILITY
------------
In the event that any clause of this Agreement shall be found to be void or
unenforceable, such findings shall not be construed to render any other clause
of this Agreement either void or unenforceable, and other clauses shall remain
in full force and effect unless the clause(s) which is/are invalid or
unenforceable shall substantially affect the rights or obligations granted to or
undertaken by either party.
22. AUTHORITY
---------
The parties hereby represent that they have full power and authority to enter
into and perform the Agreement and the parties do not know of any contract,
agreements, promises or undertakings which would prevent a full execution and
performance of this Agreement.
23. ENTIRETY
--------
This Agreement, together with its attached Exhibits, constitute the entire
agreement between TEIKOKU and ENDO with respect to the subject matter hereof and
supersedes all prior and/or contemporaneous agreements and understandings,
whether oral, written or in any other medium, that might exist between the
parties with relation to the subject matter hereof. No modification to any
provision of this Agreement shall be binding unless in writing and signed by
both TEIKOKU and ENDO. No waiver of any rights under this Agreement, will be
effective unless in writing signed by the party to be charged. All of the terms
and provisions of this Agreement shall be binding upon and inure to the benefit
of and be enforceable by the respective successors and permitted assigns of the
parties hereto.
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PAGE 24
IN WITNESS WHEREOF, the parties hereto have caused this instrument to be
executed in duplicate as of the day and year first above written by their duly
authorized officers as set forth below.
TEIKOKU SEIKAYU CO., LTD. ENDO PHARMACEUTICALS INC.
By: /s/ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇
----------------------- -----------------------
Name: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇. ▇▇▇▇▇
President & CEO
Title: President & CEO
_____________________
TEIKOKU PHARMA USA, INC.
By: /s/ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
-----------------------
Name: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Title: President & CEO
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EXHIBIT A
LIST OF TEIKOKU PATENTS, PATENT
-------------------------------
APPLICATIONS AND KNOW-HOW
-------------------------
USPTO APPLICATION NO. TITLE
-------------------- -----
08/258378 COMPOSITION OF MATTER, SPECIFIC TO PATCH FORMULATION FOR PRODUCT
AND ANY RELATED FORMULATIONS.
TEIKOKU-ENDO
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PAGE 26
EXHIBIT B
COPY OF THE SOLE AND EXCLUSIVE LICENSE AGREEMENT
------------------------------------------------
BETWEEN HIND HEALTH CARE, INC.
------------------------------
AND ENDO PHARMACEUTICALS INC.
----------------------------
TEIKOKU-ENDO
SUPPLY & MANUFACTURING AGREEMENT
PAGE 27
EXHIBIT C
ENDO'S STANDARD QUALITY CONTROL REQUIREMENTS
--------------------------------------------
FOR THIRD PARTY CONTRACTORS/SUPPLIERS
-------------------------------------
PURPOSE: This document serves as the basis for Contractor-specific Quality
-------
requirements which form the basis of the contractor management process.
1.0 GUIDING PRINCIPLES
Regarding the working relationship between quality control departments of
Contractor and Endo for Endo marketed products:
1.1 Unless otherwise specified, Endo refers to the Endo quality control
department or its designee ("Endo Quality") and the Contractor's quality
control department ("Contractor Quality").
1.2 Endo has the responsibility to provide sufficient information to Contractor
so that Contractor can ensure that the Product meets Endo quality control
specifications.
1.3 Contractor is responsible for ensuring that the Product meets Endo quality
control specifications for the duration of the Product shelf life.
2.0 MAINTENANCE OF COMPLIANCE BETWEEN THE PRODUCT REGISTRATION AND PRODUCT
MANUFACTURING PROCESS
2.1 Technical Changes
-----------------
(2.1) Contractor will supply to Endo a copy of the following:
. current manufacturing formula
. in-process test specifications and methods
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. stability test specifications and methods
. release test specifications and methods
. sources of all ingredients, specifications
Any revisions to such specifications and methods shall be provided to
Endo at the time such revisions are made.
(2.1.2) Where Endo holds the Product registration: All Contractor-proposed
product process changes will be communicated to Endo for initial review and
approval of the plan for change. This will enable Endo to assess if any
changes to the Product registration need to be made. In addition,
notification of the proposed Contractor process changes will allow Endo to
maintain adequate control over the quality components of the product
marketing authorization filed by Endo with the applicable regulatory
agencies.
(2.1.3) Endo will notify the Contractor of any process changes it wishes
to make to the Product Registration to enable the Contractor to keep the
process in line with such registration.
(2.1.4) Where required, following validation of a process change by
Contractor, Contractor will supply a copy of the related validation
protocol and report to Endo and associated stability data, as it becomes
available.
(2.1.5) Contractor is responsible for maintaining a system to implement
any compendial changes.
2.2 Labeling/Packaging Material Changes
-----------------------------------
(2.2.1) Endo may initiate changes in the product labeling or packaging
material. Endo will also review and approve any Contractor-proposed
changes. This includes a change in the supplier of any labeling or
packaging material.
(2.2.2) The Contractor shall provide Endo with a sample and new ▇▇▇▇ of
Materials prior to implementation of any change in labeling or packaging
materials.
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2.3 Other Changes
-------------
The Contractor will communicate any proposed changes in storage or shipping of
Product to Endo for review and approval prior to implementation of such changes.
The Contractor will also inform Endo of any planned changes in facilities or
equipment.
3.0 BATCH RELEASE
3.1 Batch review and release will be the responsibility of a Contractor
Qualified Person, who will act in accordance with Contractor's policies,
which must be in compliance with Product registration.
3.2 For each batch released by the Contractor for sale by Endo, the Contractor
will send to Endo a "Certificate of Conformance." The "Certificate of
Conformance" will include a statement that the batch has been manufactured
according to cGMPs and the specifications as approved by the applicable
regulatory authorities, and is released for sale or supply. In addition,
it will include the following:
.. Name, lot number and expiry date of the Finished Product.
.. Where applicable, date of manufacture of the Bulk Dosage form and lot
number if different.
.. Total amount of packages released.
Further, the agreed upon batch documentation will be sent according to timelines
to be agreed upon by Endo and the Contractor. At a minimum, the Certificate of
Analysis will be attached.
Final Product acceptance by Endo may be dependent upon this review and/or
retesting.
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3.3 The Contractor must have a formal retest policy and procedure in place that
is in accordance with applicable regulations.
3.4 The Contractor will notify Endo immediately in the event of any deviations
during manufacture and when any test reveals contamination, or degradation
in any batch of Product and file any reports required by regulations.
4.0 BATCH DOCUMENTATION
4.1 Originals of all batch documents will be retained by the Contractor
according to Regulatory and Company requirements.
4.2 In the case of a request from Endo, the Contractor agrees to provide a copy
of any of the following batch documents for supplied Products to Endo by
facsimile or courier within 24 hours:
.. Analytical and Microbiological Test Results (finished Product and
In-Process)
.. Deviation Reports
.. Inspection Records
.. Investigation Reports
.. Label Room Samples
.. Labeling Component Destruction Record
.. Line Clearances
.. Packaging Samples
.. Reconciliation Sheets
.. Coded Material
.. Packaging
.. Yield
.. Rejects Record
.. Temperature and Humidity Charts
.. Weighing Records of Active Drug Substances and Excipients
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5.0 RETENTION SAMPLES
5.1 Unless Endo agrees to maintain retention samples, the Contractor shall
retain under proper storage conditions such samples of Products as required
to comply with retention sample requirements and/or registration
commitments but in no case less than that amount needed to perform two
complete sets of finished Product testing. Testing of retention samples may
be initiated by Endo. Retention samples cannot be tested by Contractor
without the express consent of Endo.
6.0 STABILITY
6.1 The Contractor must have systems in place to insure that Product released
will meet all criteria throughout its shelf life.
6.2 For each Product for which the Contractor is responsible for performing
stability, Endo requires that a minimum of one Production lot per year per
Product put up, have representative samples withheld for stability testing
unless a reduced stability program is agreed to by both parties. Samples
shall be stored and tested at appropriate intervals, as described in an
approved stability protocol. Endo will approve stability protocols for
Products for which Endo holds the registration and technology. Any changes
in approved protocols must be reviewed and approved by Endo.
6.3 If a confirmed result indicates the Product has failed to remain within
specifications, the Contractor is required to notify Endo immediately.
Notification will include discussion of problems, data available, and path
forward. In addition, a copy of the investigation report or information on
corrective action(s) should be sent to Endo as soon as they become
available.
6.4 As part of the annual Product review, the Contractor will provide to Endo a
summary stability report on each Product. The report should contain
cumulative tabular result information on all active studies. The Contractor
is expected to analyze the data and provide a written summary attesting to
the ongoing acceptability of the Product.
TEIKOKU-ENDO
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6.5 Alert limits will be established. The Contractor is required to notify
Endo of any confirmed out of alert results within three (3) business days
and provide the data to Endo.
6.6 In all cases, the Contractor must investigate any confirmed out of limit
result and forward a copy of the completed investigation report to Endo
within thirty (30) business days.
6.7 The Contractor must have a formal stability retest policy and procedure in
place that is in accordance with applicable regulations.
6.8 In the event that the Agreement between Contractor and Endo is terminated,
the Contractor will continue to provide Endo with stability data supporting
the acceptability of the Product until all Product distributed by Endo has
reached the end of its shelf life.
7.0 COMPLAINTS
7.1 Product complaint reports received by Endo from its customers will be
summarized and sent by facsimile to the Contractor. Product complaint
reports received by the Contractor will be summarized and sent within one
(1) business day by facsimile to Endo. Product complaint reports which may
require reporting to appropriate government agencies will be promptly
communicated and the agreed upon party will notify authorities of such
reports within three (3) working days following receipt.
7.2 The Contractor will investigate all Product complaints associated with
Contractor-provided services and provide Endo with a written report within
thirty (30) days after receipt of the complaint. If Endo deems it
necessary, Endo may further investigate, with the cooperation of
Contractor, such complaints. Endo will provide a written response to the
complainant, with a copy to the Contractor, when applicable.
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8.0 RECALL
8.1 In the event that either party has reason to believe that any one or more
lots of Product or any Product component should be recalled or withdrawn
from distribution, such party shall immediately inform the other in writing
prior to taking any such action.
8.2 Endo and the Contractor will consult to determine whether or not a recall
of a Product is required and the process to be followed to execute such
recall.
8.3 Both parties must forward to the other party a copy of any regulatory field
alerts prior to sending an alert to the appropriate regulatory authorities.
9.0 ANNUAL PRODUCT REVIEW
9.1 Each year the Contractor will provide for each Product supplied to Endo an
Annual Product Review, or if otherwise agreed by Endo and Contractor,
sufficient information to support Endo's Annual Product Review.
9.2 When the Contractor agrees to provide an Annual Product Review, the Annual
Product Review will contain:
For all batches manufactured:
.. Total number of batches manufactured
.. Total number of batches packaged
.. Number of batches reworked
.. Number of batches rejected
.. Number of batches recalled
.. A review and summary of customer complaints
.. A listing and discussion of recalls
.. A listing and review of changes
.. A listing and review of stability data
.. Results of visual inspection of retained samples
TEIKOKU-ENDO
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For batches supplied to Endo:
.. A listing of Product batches supplied by batch number and date delivered
to Endo
.. A review and summary of analytical results for those batches including any
retest results and investigations
.. A listing and review of process deviations/investigations
.. Discussion, evaluation and conclusions
9.3 Endo will review and approve the Annual Product Review for Products for
which Endo holds the registration and owns the technology.
10.0 AUDITS
10.1 Endo will schedule periodic audits of the Contractor's facilities. If
requested, the Contractor shall grant access for additional Product
specific audits by Endo.
10.2 Endo shall have the right to visit the Contractor's plant where Products
are manufactured on any business day upon reasonable prior notice to the
Contractor. During any such visit, Endo shall have the right to audit the
Contractor's manufacturing and quality control procedures, records, and
facilities as well as registrations, supplements, and regulatory
correspondence to ensure that the Contractor complies with the Product
registration and with current Good Manufacturing Practice regulations or
other procedures required by Endo. The Contractor shall take a course of
action and resolution acceptable to Endo in the event that Endo finds any
contractual or regulatory deficiencies during such audit.
TEIKOKU-ENDO
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11.0 INSPECTIONS/LEGAL ACTIONS
11.1 Upon receipt, the Contractor shall provide Endo with copies of inspection
reports, and/or legal actions (and access to copies of all notices,
correspondence, and telephone contact reports) with or by governmental
agencies relating to its manufacturing facilities or any Product
manufactured or tested by the Contractor on behalf of Endo unless otherwise
agreed to by the parties.
12.0 SUPPLIER QUALIFICATION
When the Contractor agrees to provide materials supplied by other vendors, the
Contractor must maintain a formal supplier qualification and management program.
Selection, qualification, and management of sub-Contractors are the
responsibility of the Contractor in these instances, unless otherwise agreed
upon.
13.0 TRAINING
Each person engaged in the manufacturing, processing, packing, testing or
holding of a drug Product shall have education, training, and experience, or any
combination thereof, to enable that person to perform the assigned functions.
Training shall be in the particular operations that the employee performs and in
current applicable manufacturing regulations as they relate to the employee's
functions. Training in applicable manufacturing regulations shall be conducted
by qualified individuals on a continuing basis and with sufficient frequency to
assure that employees remain familiar with requirements applicable to them.
This training must be documented in a training record for each employee.
Where applicable, Endo will provide the Contractor with Product specific
training as part of any technology transfer process.
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14.0 VALIDATION
14.1 The Contractor must maintain a formal validation program for:
.. Validation planning
.. Facilities
.. Equipment
.. Methods
.. Cleaning
.. Process
.. Processes controlled by Contractors Computer system
Validation may be prospective, concurrent or retrospective but in all cases,
critical parameters and acceptance criteria must be documented.
Product related validation protocols must be reviewed and approved by Endo prior
to execution.
Where applicable, Endo may require process or test method qualification as part
of any technology transfer process.
TEIKOKU-ENDO
SUPPLY & MANUFACTURING AGREEMENT
PAGE 37
EXHIBIT D
TEIKOKU STANDARD OPERATING PROCEDURES WITH REGARDS TO THE PRODUCT
TEIKOKU-ENDO
SUPPLY & MANUFACTURING AGREEMENT
PAGE 38
EXHIBIT E
PRICE AND TERMS FOR COMMERCIAL QUANTITIES
-----------------------------------------
OF PRODUCT AND PRODUCT SAMPLES
------------------------------
1. Price for the Product
Annual Quantity of Envelopes Unit Cost per Commercial Package Envelope,
---------------------------- CIF,ENDO's Distribution Center, USA.
-------------------------------------------
*** ***
a) All Sample Packages shall be sold to ENDO for *** per Envelope for up to
*** units of Samples.
b) The above Unit Costs per Envelope shall be guaranteed up to and including the
third anniversary date of the product Launch in the United States. "Product
Launch" shall mean the first commercial sale of the Product by ENDO for resale
or use to an unaffiliated third party in the Territory.
c) Commencing on the fourth anniversary date of the Product Launch in the
United States and thereafter, the Unit Cost per Envelope shall be adjusted
annually in an amount equal to the percentage change in the rate of inflation
from the previous calendar year to the next calendar year, as measured by the
Japanese Consumer Price Index, such adjustments may result in an increase or
decrease in the Unit Cost per Envelope in accordance with such annual inflation
rate, provide, however, that in no event during the term of this Agreement,
shall this Paragraph result in ENDO paying
TEIKOKU-ENDO
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PAGE 39
more than a cumulative total of *** (***%) for an Envelope over the Envelope
prices set forth above. In the event that the cumulative inflation rate in Japan
during the term of this Agreement, exceeds ***%, the parties will meet to
reasonably discuss the price for the Product.
The parties hereby agree that for purposes of this Agreement, the Yen shall be
valued to the US Dollar in a range of ***-***-Yen to $1.00 USD (the Yen Range).
Commencing from January 1, 2000, in the event that the value of the Yen falls
outside the Yen Range, the parties shall share equally the benefit and liability
of such Yen fluctuation. The parties shall reconcile their exchange
transactions at the end of each calendar quarter.
d) Annual Minimum Orders. ENDO shall purchase the following minimum orders of
Product, on an annual basis, commencing with the first twelve (12) months after
the Product Launch:
Year 1 - *** envelopes
Year 2 - *** envelopes
Year 3 - *** envelopes
2. Package Size
------------
a) Commercial Package. Each Envelope shall contain five (5) patches (10 X 14
------------------
cm). Each Commercial Package shall contain six (6) Envelopes. Any changes to
the package size and the allocation, if any, of any associated expenses shall
be agreed to by the parties prior to such package size change.
b) Samples. Each Sample Package shall contain two (2) Patches in an
Envelopes.
3. Shipping Units
--------------
The Product shall be shipped to ENDO's designated Distribution Center in a 40
foot reefer container which will include 90,000 Envelopes + 10%.
-