EXHIBIT 10.44
LICENSE AND SUPPLY AGREEMENT
dated as of August 20, 1997
between
EURAND AMERICA, INC.
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇
and
GLOBAL PHARMACEUTICAL CORPORATION
▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
for
Diffucaps(R) Pancreatin
Table of Contents
1. DEFINITIONS ..................................................... 4
2. GRANT OF LICENSE ................................................ 7
2.1 GRANT OF LICENSE .................................... 7
2.2 THE EXCLUSIVITY OF THE LICENSE ...................... 7
3. OWNERSHIP AND USE OF KNOW-HOW ................................... 7
3.1 OWNERSHIP ........................................... 7
4. SALE OF THE PRODUCT ............................................. 7
4.1 STANDARD OF MANUFACTURE ............................. 7
4.2 RIGHT OF REVIEW ..................................... 8
4.3 REPRESENTATIONS AND WARRANTIES ...................... 8
4.4 PURCHASE AND SALE ................................... 9
4.5 DELIVERY SCHEDULE ................................... 9
4.6 TITLE, RISK OF LOSS ................................. 10
5. PRICES .......................................................... 10
5.1. PRICES AND PRICE CHANGES ............................ 10
5.2 PAYMENT TERMS ....................................... 11
6. ROYALTIES ....................................................... 11
6.1 ROYALTIES ........................................... 11
6.2 TAXES ............................................... 12
6.3 CURRENCY ............................................ 12
2
7 TERM ............................................................ 12
7.1 BASIC TERM .......................................... 12
7.2 EARLY TERMINATION BY REASON OF PATENT LITIGATION .... 13
8.. EVENTS OF DEFAULT, REMEDIES AND EFFECTS OF DEFAULT .............. 14
8.1 EVENTS OF DEFAULT ................................... 14
8.2 REMEDIES FOR BREACH ................................. 14
9. INDEMNIFICATION ................................................. 14
9.1 INDEMNIFICATION OF GLOBAL ........................... 14
9.2 INDEMNIFICATION OF EURAND ........................... 15
9.3 NOTICE AND LEGAL DEFENSE ............................ 15
10. MISCELLANEOUS ................................................... 16
10.1 ASSIGNMENT .......................................... 16
10.2 CONFIDENTIALITY ..................................... 16
10.3 EXCHANGE OF INFORMATION ............................. 17
10.4 FORCE MAJEURE ....................................... 18
10.5 AMENDMENTS .......................................... 18
10.6 NO IMPLIED WAIVER ................................... 18
10.7 CHOICE OF LAW ....................................... 18
10.8 NOTICES ............................................. 18
10.9 EXECUTION OF ADDITIONAL ............................. 19
10.10 SEVERABILITY ........................................ 19
10.11 CAPTIONS ............................................ 19
10.12 COUNTERPARTS ........................................ 19
10.13 MINIMUM ANNUAL PURCHASES ............................ 19
3
THIS LICENSE AND SUPPLY AGREEMENT, dated as of August 20, 1997 (the
"Effective Date"), between EURAND AMERICA, INC., a corporation
organized under the laws of Nevada, with its principal offices at ▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇ ("EURAND"), and GLOBAL
PHARMACEUTICAL CORPORATION, a corporation organized under the laws of
the State of Delaware, with its principal offices at ▇▇▇▇▇▇ &
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇ ("GLOBAL");
WITNESSETH THAT:
WHEREAS, EURAND is the owner of original processes and know-how for the
manufacture of sustained release pharmaceutical substances;
WHEREAS, EURAND and GLOBAL entered into a Confidentiality Agreement
(the "Confidentiality Agreement"), pursuant to which the parties exchanged
confidential information relating Lo this Proposed cooperative effort;
WHEREAS, GLOBAL desires to receive a license to market and sell
products containing sustained release products as developed and manufactured by
EURAND and EURAND is willing to grant such a license on the terms and conditions
set forth hereinafter;
NOW, THEREFORE, in consideration of the agreements and covenants
hereinafter set forth and intending to be legally bound hereby, the parties
hereto covenant and agree as follows:
1. DEFINITIONS
1.1 "Active Ingredient" means the mixture of lipases, proteases
and amylases set forth in Exhibit B.
1.2 "Affiliate" means, with reference to any Person, any other
Person directly or indirectly, controlling, controlled or
under common control with such Person, and "control" means
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the power to direct the management and policies of a Person,
whether through the ownership of voting securities, by
contract or otherwise.
1.3 "Applicable Laws" means all laws, treaties, ordinances,
judgments, decrees. directives, injunctions, orders of any
court, arbitrator or governmental agency or authority, rules,
regulations, interpretations, authorizations and Applicable
Permits of any international, national, regional, local or
other governmental body, agency, authority, court or person,
on having jurisdiction over or related to the registration,
manufacture and sale of the Product, as may be in effect from
time to time.
1.4 "Applicable Permits" means any waiver, exemption, variance,
permit, license or similar approval, including, without
limitation, product registrations by health or other
government entities, required to be obtained or maintained
under Applicable Laws in connection with the development
registration, manufacture and sale of the Product.
1.5 "Contract Year" means, for the first Contract Year, the period
ending twelve (12) months after the date first above written
and for the second and subsequent Contract Years, the twelve
(12) month period commencing on the day following the
anniversary of the end of the first and subsequent Contract
Years, respectively.
1.6 "FDA" shall mean the Food and Drug Administration in the
United States.
1.7 "Force Majeure" means any cause or causes which wholly or
partially prevent or delay the performance of obligations
arising under this Agreement and which are not reasonably
within the control of the non-performing party, including acts
of God, government regulations, labor disputes, floods, fires,
civil commotion, embargoes, quotas, shortage of labor or
materials or any delays in transportation or detention by
customs, health or other government authorities.
1.8 "Know-How" means proprietary know-how, trade secrets,
inventions, data, technology and other proprietary
information, which a party hereto has the lawful right to
disclose to
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the other party "Know-How" shall include, without limitation,
processes and analytical methodology used in development,
testing, analysis and manufacture and medical, clinical
toxicological testing as well as other scientific data.
1.9 "Finished Dosage Form" means the composition produced by
Global from the Product, labeled packaged and ready for sale
to wholesalers, current and/or potential customers.
1.10 "Product" means gastro-protected pancreatin compositions
containing the Active Ingredient and certain excipients, said
composition being produced by EURAND and meeting the
Specifications (as hereinafter defined). As used herein to
distinguish among the Products, the notations "Product A" and
"Product B" shall mean, respectively, those Products having
USP Lipase contents of 4,500 and 10,000, all of which are
included in the definition of Products.
1.11 "Product Formulation" means the developed formulation required
to convert the Active Ingredient into Product.
1.12 "Net Royalties" means royalties due on Net Sales.
1.13 "Net Sales" means the aggregate invoiced sales of the Finished
Dosage Form by GLOBAL less returns (excluding recalls and
which shall not to exceed 7%), discounts, rebates, and
shipping charges, as well as duties, customs or other
governmental charges.
1.14 "Person" means any individual, partnership, association, joint
venture or corporation.
1.55 "Specifications" means the specifications for the Products set
forth in Exhibit B.
1.16 "Territory" means the United States of America, its
territories and possessions.
1.17 "Act'," shall mean the Federal Food, Drug and Cosmetic Act, as
amended from time to time.
1.18 `cGMP' shall mean current Good Manufacturing Practices as
defined in regulations promulgated by the FDA under the Act.
1.19 "Effective Date" shall mean the date set forth in line 1 of
page 4 hereof.
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2. GRANT OF LICENSE
2.1 Grant of (license. Subject to the terms set forth herein and
in consideration for the payments set forth in Article 8.1
hereof, EURAND hereby grants to GLOBAL an exclusive
royalty-bearing license within the Territory to use, offer for
sale and sell the Products. Global acknowledges that its
license hereunder as it relates to Product A is a
semi-exclusive license subject to a previous license granted
to Scandipharm for the territory.
2.2 Exclusivity. The exclusivity of the license granted pursuant
to Paragraph 2.1 may be converted to non-exclusive by
operation of Paragraph 10.13.
2.3 Competing Dosage Forms. The license granted under Paragraph
2.1 hereof shall automatically convert to non-exclusive
throughout the Territory should GLOBAL market another product
containing pancreatic enzymes in a dosage form similar or
identical to the Product, except for products supplied to
Global by Eurand or products containing pancreatic enzymes in
combination with other active ingredients.
3. OWNERSHIP AND USE OF KNOW-HOW
3.1 Ownership. Know-How related to the Active Ingredient, the
Products and/or their production (including modifications or
improvements thereto) is the property of EURAND. Know-How
owned prior to the date hereof by either party Shall continue
to be owned exclusively by such party.
4. SALE OF THE PRODUCT
4,1 Standard of Manufacture. EURAND shall supply GLOBAL with
Product meeting the Specifications. All Product supplied by
EURAND to GLOBAL hereunder Shall be produced in accordance
with cGMP and shall not be adulterated or misbranded within
the
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meaning of the Act. Each shipment of Product from EURAND to
GLOBAL shall be sampled and analyzed by EURAND to determine if
the shipment meets the Specifications. EURAND shall deliver to
GLOBAL with each shipment of the Product a certificate of
analysis stating that the Product meets the Specifications.
EURAND shall maintain all batch records relating to the
manufacture of the Product. GLOBAL may audit such batch
records upon the provision of reasonable notice to EURAND
4.2 Right of Review, GLOBAL may conduct its own analyses on each
shipment of the Product received pursuant to this Agreement.
GLOBAL shall notify EURAND within sixty (60) days after
delivery of the Product if the same does not meet the
Specifications or is adulterated or misbranded within the
meaning of the Act. Any dispute arising between EURAND and
GLOBAL concerning the conformity of any shipment of Product
which cannot be settled between the two parties, shall be
submitted to an independent expert. Said independent expert
shall be mutually agreed by the parties. In the event that
such agreement cannot be reached, each party will
independently select an independent expert and such two (2)
independent experts shall select a third independent expert
who will than determine if the product meets the
specifications or is in misbranded or adulterated within the
meaning of the act. The decision of said expert shall be
binding on EURAND and GL0BAL. The charges, including the fees
and expenses of the expert, relating to any dispute described
in this paragraph shall be paid by EURAND if the expert
declares the delivery not to be in conformity or by GLOBAL if
the expert declares the delivery to be in conformity. GLOBAL
is responsible for release of Finished Dosage Form for sale.
4.3 Representations and Warranties.
(a) Each party represents and warrants to the other that
it is authorized to enter into and to perform its
obligations under this Agreement.
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(b) Each party represents and warrants to the other that
tile rights granted by it hereunder and its
obligations created under this Agreement do not
conflict in any manner with any rights previously
granted by it or any of its previous obligations.
(c) EURAND represents that:
(i) the Product delivered pursuant to this
Agreement shall meet the Specifications and
shall not be adulterated or misbranded
within the meaning of the Act;
(ii) it will comply with all Applicable Laws in
the United States (or any other country of
Product manufacture) in the production of
the Product;
(iii) the use. manufacture, distribution and/or
sale of the Product, Product Formulation
and/or Active Ingredient in any portion of
the Territory does not violate or infringe
in any respect and it has no knowledge of
any pending or threatened claim or legal
action asserting that the use, manufacture,
distribution or sale of the Product in the
Territory constitutes an infringement of
extant patents, trade Secrets trademarks, or
other extant industrial or intellectual
property rights of any third party, and
(iv) there is no pending or threatened claim or
legal action concerning adulteration or
misbranding of the Product in the Territory.
EURAND expressly disclaims all other warranties whether express or
implied with respect to the Product, whether as to merchantability, fitness for
a particular purpose or any other matter.
4.4 Purchase and Sale. Subject to the provisions of Article 2,
EURAND shall sell and deliver to GLOBAL, and GLOBAL shall
exclusively purchase EURAND's product and accept, GLOBAL's
total requirements of Product for the Territory as ordered
pursuant to Paragraph 4.5 below.
4.5 Delivery Schedule. Commencing on the effective date of this
Agreement, GLOBAL shall establish a four (4) calendar quarter
forecast covering its estimated requirements, based
9
on manufacturing batch sizes and multiples thereof, and the
desired delivery dates of the Product. No later than September
3O and March 31 of each calendar year during the term of
this Agreement, GLOBAL shall provide EURAND with a good faith
estimate of the amount and timing of the Product to be
delivered to GLOBAL during the four (4) quarters commencing
die following January 1 and July 1, respectively. GLOBAL shall
place its firm orders at least twelve (12) weeks prior to the
desired date of shipment. EURAND shall not be obligated to
fill orders exceeding the immediately preceding forecast by
more than thirty percent (30%) but shall make commercially
reasonable efforts to do so.
4.6 Title, Risk of Loss. Risk of loss with respect to the Product
shall pass from EURAND to GLOBAL upon delivery to GLOBAL's
carrier at EURAND's manufacturing plant. Title to the Product
shall pass to GLOBAL upon receipt of payment for said Product.
5 PRICES
5.1 Prices and Price Changes.
(a) EURAND shall sell. and GLOBAL shall buy, the Products
at the initial prices set out in Exhibit A.
(b) EURAND shall be entitled to adjust the price set
forth in Article 5.1(a) to reflect changes in its
manufacturing costs. Such adjustments may be made no
more than once per calendar year in accordance with
its manufacturing costs. EURAND shall notify GLOBAL
of the revised price of the Product during the last
quarter of each calendar year during the term of the
Agreement. The revised price sha11 be applied to any
delivery of Product made during the following
calendar year. In addition. the price applicable
during any calendar year may be adjusted by EURAND as
soon as is practicable after thirty (30) days written
notice to GLOBAL, to cover one hundred percent
(1.00%) of any additional cost or expense of
manufacturing
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Product, to the extent that a change in manufacturing
technique is requested by GLOBAL or required by a
change in Applicable Laws (including a change in
cGMP), or due to an increase in the cost of raw
materials.
5.2 Payment Terms. EURAND shall send to GLOBAL an invoice showing
the amount due under Section 5.1 with each shipment. GLOBAL
shall pay EURAND the amount due thirty (30) days from the date
of invoice. GLOBAL shall have the right, however, to set off
against invoices received for Product to the extent that
Product previously received and paid for by GLOBAL is properly
rejected in accordance with Paragraph 4.2 hereof
6. ROYALTIES
6.1 Royalties.
(a) GLOBAL shall pay EURAND a Net Royalty of five percent
(5%) of the Net Sales of the Finished Dosage Form
sold by GLOBAL in the Territory during the term of
this Agreement beginning January 1, 1998. No later
than thirty (30) days after the end of each calendar
quarter, GLOBAL shall report to EURAND the Net Sales
of the Products and the Net Royalties due during each
calendar quarter in the Territory 'in the previous
calendar quarter. The payment by GLOBAL to EURAND
shall be in US, Dollars and shall be made within
forty-five (45) days after the end of each calendar
quarter. Payments shall be made by such means to
assure that the funds of such payment are immediately
available to EURAND at the end of such forty-five
(45) period. GLOBAL shall keep true and accurate
books of account and shall keep and maintain all
records and documents necessary for EURAND to
ascertain the Net Royalties due under this Agreement,
(b) Upon the provision of reasonable notice, EURAND shall
have the right to designate a firm of certified
public accountants to inspect GLOBAL's books of
account, records,
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documents and instruments and to make copies thereof,
at any time during GLOBAL's regular business hours
during the term of this Agreement and for a period of
two (2) years immediately after termination of this
Agreement, to ascertain the accuracy of such report.
The cxpense of such audit shall be EURAND's unless
the audit shall demonstrate a discrepancy greater
than five (5%) between Net Royalties reported and
paid and those which were actually due, in which
event the expenses of audit shall be borne by GLOBAL.
Such audits shall not be conducted more frequently
then once per calendar year.
6.2 Taxes. All taxes, assessments, fees and other charges, if any,
levied under the laws or regulations with respect to payments
due to EURAND hereunder shall be for the account of EURAND,
and if required to be withheld from payments to EURAND, shall
be deducted by GLOBAL, from such payments to EURAND. Receipts,
if available, for all such withholdings shall be provided to
EURAND. GLOBAL shall be responsible for establishing its right
to claim any exemption to such charges or to its withholding,
shall keep EURAND advised in writing of the basis and status
of all such exemption claims, and except to the extent such
exemption claim is based upon the false, inaccurate or
misleading information furnished by or on behalf of Eurand
shall be liable for any penalty, interest or other assessment
against EURAND arising solely from such failure to pay or
withhold such charges in reliance on any such exemption
claim.
6.3 Currency. All payments to be paid to EURAND hereunder shall be
computed and made in United States Dollars.
7. TERM
7.1 Basic Term. Unless modified by the operation of Article 7.2
hereof, this Agreement shall be effective from the date first
above written and shall continue for an initial period
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of ten (10) years. Thereafter, this Agreement shall
automatically renew itself and thereby continue in force for
consecutive periods of two (2) years, provided that this
Agreement may be terminated by either party upon provision of
one (1) year's prior written notice delivered to the other
party at any time during the initial term or the subsequent
two (2) year terms.
7.2 Early Termination by Reason of Patent Litigation.
Notwithstanding Section 7.1 hereof, in the event that either
parry to this Agreement is named in a third-party patent
litigation related to the subject matter of this Agreement and
that seeks an award of damages or an injunction, either parry
shall have the right at any time thereafter to terminate this
Agreement upon sixty (60) days prior written notice without
further obligation to the other except for obligations
incurred prior to the time of such notice.
So long as the license granted pursuant to Article 2
hereof is exclusive, prior to early termination of this
Agreement, the parties agree to seek an opinion from an
independent patent counsel acceptable to both parties. If such
patent counsel determines their the Product and/or Finished
Dosage Form cannot be made, used, marketed and/or in the
Territory under the rights possessed by the parties without
infringing the rights of such third party, the parties shall
jointly or independently endeavor to secure a license from the
third party on terms acceptable to both parties. If such
license cannot reasonably be secured, either party may
terminate the Agreement as provided immediately above.
7.3 Sale of Finished Dosage Form. Following Termination. Unless
termination of the Agreement occurred due to a breach by
GLOBAL, GLOBAL may sell its inventory of Finished Dosage Form
existing as of the date of such termination for a period of up
to
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six (6) months. Such termination shall not relieve GLOBAL of
its royalty obligations on such sales.
8. EVENTS OF DEFAULT, REMEDIES AND EFFECTS OF DEFAULT
8.1 Events of Default. An event of default under this Agreement
shall be deemed to exist upon the occurrence of any one or
more of the following events.
(a) failure by either party hereto to perform fully any
material provision of this Agreement and such failure
continues (i) for a period of sixty (60) days after
notice of such nonperformance or (ii) if the
non-performing Party shall commence within such sixty
(60) days and shall thereafter proceed with all due
diligence to cure such failure, such Failure is not
cured within such longer period (not to exceed sixty
[60] days) as shall be reasonably necessary for such
party to cure the same with all due diligence; or
(b) failure of GLOBAL to pay any amount due to EURAND,
failure continues for a period of thirty (30) days
after written notice of such non-payment; unless,
however, such nonpayment is due to a good faith
dispute concerning the amount owed.
8.2 Remedies for Breach Termination, Upon the occurrence and
during the continuation of any event of default thereunder,
the party not in default may terminate this Agreement in whole
or only with regard to the provision which has given rise to
the event of default and pursue any other remedies provided
under this Agreement or available at law.
9. INDEMNIFICATION
9.1 Indemnification of GLOBAL. EURAND shall indemnify and hold
GLOBAL harmless from and against all damages, losses,
expenses, claims, demands, suits, penalties, judgments or
administrative and judicial orders and liabilities (including
reasonable
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counsel fees and expenses) incurred, assessed or sustained by
GLOBAL, its officers, directors, employees and agents with
respect to or involving or arising out of a breach of EURAND'S
warranties in Section 4.3 hereof by EURAND and/or the
manufacturing of the Product regardless of whether the claim
is based in contractor strict liability, warranty or any other
legal theory.
9,2 Indemnification of EURAND. GLOBAL shall indemnify and hold
EURAND harmless from and against all damages, losses,
expenses, claims, demands, suits, penalties, judgments or
administrative and judicial orders and liabilities (including
reasonable counsel fees and expenses) incurred, assessed or
sustained by EURAND, its officers, directors, employees, and
agents regardless of whether the claim is based in contract,
strict, liability, warranty or any other legal theory (i) not
covered by EURAND's indemnification under 9.1 hereof and/or
(ii) with respect to or involving or arising out of a breach
of warranties in Section 4.3 hereof by GLOBAL.
9.3 Notice and Legal Defense. Promptly after receipt by a party
hereunder of any claim Or notice of the commencement of any
action, administrative or legal proceeding, or investigation
as to which the indemnity provided for in Paragraph 9.1 and
9.2 hereof may apply, the party seeking indemnification shall
notify the indemnifying party of such fact; provided that the
failure to so notify shall not release an indemnifying party
or its obligation hereunder unless such failure shall be
materially detrimental to tire defense of any such action,
proceeding an investigation. The indemnifying party shall
assume the defense thereof; provided, however, that if the
defendants in any such action include both the party seeking
indemnification and the indemnifying party and the party
seeking indemnification shall reasonably concluded that there
may be legal defenses available to it which are different from
or additional to, or inconsistent with, those available to the
indemnifying party, the party seeking indemnification shall
have the right to select
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separate counsel to participate in the defense of such action
on behalf of such party seeking indemnification, at the
indemnifying party's expense.
10. MISCELLANEOUS
10.1 Assignment. Neither this Agreement nor any interest herein may
be assigned, in whole or in part. by either party hereto
without the prior written consent of the other party hereto,
provided, that either party shall leave the right to assign
all or part of its rights, interest and obligations to an
Affiliate, a successor to a controlling or majority share of
such party, or to a successor to substantially all the
business to which this Agreement relates. Subject to the
foregoing, this Agreement shall be binding upon and inure to
the benefit of the parties hereto and their respective
permitted successors and assigns.
10.2 Confidentiality.
(a) Any and all information provided by one party to the
other pursuant to this Agreement or the
Confidentiality Agreement shall be deemed to be
confidential information ("Confidential
Information"). The obligations of Confidentiality
present in this Agreement supersede those contained
in the Confidentiality Agreement. Each party will
hold Confidential Information in complete confidence
and will not, without the prior written consent of
the other, use or disclose it in whole or in part to
any person other than for the purposes set forth in
this Agreement for a period ending five (5) years
following expiration of this Agreement. Each party
will be entitled to disclose any such Confidential
Information to such of its professional advisers,
directors, officers and senior employees who are
directly concerned with this Agreement and its
implementation and whose knowledge of such
information is necessary for these purposes. Each
party will use its reasonable efforts to ensure that
each individual to whom such a
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disclosure is made adheres to the terms of this
undertaking as if he or she were a party hereto,
including without limitation, having such individuals
execute similar agreements.
(b) As used herein, the term Confidential Information
shall not include information:
(1) which at the time of disclosure to the other
is in the public domain;
(ii) which, after disclosure, becomes generally
available to third parties from a source
other than the discloser; provided that such
source is not bound by a confidentiality or
other similar agreement with the discloser
or by any other legal, contractual or
fiduciary obligation which prohibits the
disclosure of such Confidential
Information,
(iii) which was lawfully in possession of the
recipient prior to disclosure, as evidenced
by written records and which was not
acquired directly or indirectly from the
discloser; or
(iv) which the recipient is required to disclose
or, after consultation with legal counsel,
determines it prudent to be disclosed to the
extent required under the laws, guidelines,
or regulations or pursuant to any request by
any governmental agency lawfully requesting
the same, or to any court of competent
jurisdiction acting pursuant to its powers.
10.3 Exchange of Information. GLOBAL and EURAND will periodically
inform each other about any useful marketing information
concerning the sales of the Product in the Territory. Each
party will timely report to the other any information
concerning any side effect, injury, toxicity or sensitivity
reaction associated with clinical uses, studies,
investigations or test of the Active Ingredient, Product,
Product Formulation or Finished Dosage Form. In reporting such
incidents, the reporting party will use reasonable efforts
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to indicate whether. in its judgment, any of them are
unexpected or unusual in type, incidence or severity.
10.4 Force Majeure. Each of the parties shall be excused from the
performance or delay in performance of its obligations under
this Agreement in the event such performance is prevented by
Force Majeure and such performance shall be excused as long as
the condition constituting such Force Majeure continues plus
an additional thirty (30) days after termination of such
condition; provided, that the non-performing party shall
provide prompt notice to the other party of the particulars of
the occurrence constituting Force Majeure and of its cessation
and shall make diligent efforts to mitigate the adverse
consequences of such nonperformance or delays in performance,
10.5 Amendments. No amendment or modification of the terms of this
Agreement shall be binding on either party unless reduced to
writing and signed by both parties.
10.6 No Implied Waiver. Failure by either party hereto on one or
more occasions to avail itself of a right conferred by this
Agreement shall in no event be construed as a waiver of such
party's right to enforce said right in the future.
10.7 Choice of Law. This Agreement and all rights and obligations
hereunder, including matters of construction, validity and
performance, shall be governed by and construed in accordance
with New Jersey law without giving effect to its conflict of
laws principles.
10.8 Notices. Any notice and other communication required or
permitted to be given hereunder shall be in writing and shall
be deemed given when delivered personally, telecopied or
received by registered mail, return receipt requested, to the
parties at the following addresses:
If to EURAND, to:
EURAND AMERICA, INC.
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇
Attn: VP Business Development
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Fax: (▇▇▇) ▇▇▇-▇▇▇▇
If to GLOBAL, to:
GLOBAL PHARMACEUTICAL CO.
▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attn: ▇▇. ▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇
President and CEO
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
With copy to:
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Esq.
▇▇▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
10.9 Execution of Additional Documents. Each party hereto agrees to
execute such further papers or agreements as may be reasonably
necessary or desirable to effect the purpose of this Agreement
and carry out its provisions.
10.10 Severability. In the event that any provision of this
Agreement shall be held invalid or unenforceable by any court
of competent jurisdiction, such Holding shall not invalidate
or render unenforceable any other provision hereof.
10.11 Captions. The article and section captions in this Agreement
have been inserted as a matter of convenience and are not part
of this Agreement,
10.12 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original of
this Agreement and all of which together shall constitute one
and the same instrument.
10.13 Minimum Annual Purchases. In order for GLOBAL to retain
exclusivity under the license granted pursuant to Article 2.1,
the Minimum Annual Purchases for each of said Products are set
forth immediately below. GLOBAL shall purchase from EURAND
during each Contract Year minimum amounts of Products as
follows:
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Purchasing Period Product A Product B
------------------ --------- ---------
1 Effective Date to December 31, 1998 22,000,000 cps. 4,000,000 cps.
2 January 1, 1999 to December 31, 1999 20,000,000 cps. 5,000,000 cps.
3 and thereafter 24,000,000 cps. 6,000,000 cps.
When the new 10,000 spheronized, encapsulated Product is available for
commercial sale, purchasing minimums for Product B will no longer be in effect.
On the Effective Date, GLOBAL shall place firm orders for 4.4 million capsules
of The Product A. Should the purchases made by GLOBAL for any of said Products
fail to reach the applicable Minimum Annual Purchase amount for that Product,
Eurand, as its sole remedy hereunder, may convert the rights granted to GLOBAL
pursuant to Articles 2.1 to non-exclusive.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the day and year first
above written.
EURAND AMERICA, INC GLOBAL PHARMACEUTICAL
/s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ /s/ ▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇
------------------------ ------------------------
▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇. ▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇
Title: Managing Director Title: President and CEO
20th Aug. '97 20th Aug. '97
20
EXHIBIT A: 1997 PRICES (initial)
Product A
---------
$63,95 per 1000 capsules FOB Vandalia
Product B
---------
$121.40 per 1000 capsules FOB Vandalia
21
EXHIBIT B: ACTIVE INGREDIENT AND PRODUCT SPECIFICATION'S
Dosage form: Pancrelipase Delayed-release Capsules
Product Strengths (label):
Product A Product B
--------- --------
Lipase 4,500 USP units 101,000 USP units
Amylase 20,000 USP units 30,000 USP units
Protease 25,000 USP units 30,000 USP units
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EXHIBIT C - MANUFACTURING COSTS
"Manufacturing cost " means the fully allocated manufacturing cost of Product
determined in accordance with U.S, generally accepted accounting principles
(GAAP) which includes and is 1imited to:
1. direct labor (salaries, wages and employee benefits);
2. direct materials;
3. operating costs of building and equipment used only in connection with
the manufacture of the Product;
4. allocated depreciation and repairs and maintenance incurred in
connection with the manufacture of Product;
5. quality and in process control incurred in connection with the
manufacture of Product
6. an allocation of overhead costs incurred in connection with the
manufacturing of Product including: raw material supply and
manufacturing administration and management; simply and material
management, storage and handling; and manufacturing and employee
training;
7. royalties paid to third parties; and
8. no charges for idle capacity or underutilized facilities shall be
included in the manufacturing cost.
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