Supply Agreement - Pharmaceutical Group of Mallinckrodt Inc. and DrugAbuse Sciences Inc.
DRUGABUSE SCIENCES, INC. SUPPLY AGREEMENT
This Supply Agreement is made and entered into effective on and as of
June 9, 2000 by and between the Pharmaceutical Group of Mallinckrodt Inc.
("Mallinckrodt") and DrugAbuse Sciences ("DAS").
WHEREAS, DAS has need of a certain compound known as Naltrexone Base
Anhydrous (hereinafter "Product") and is desirous of having Product
manufactured and supplied by Mallinckrodt on the conditions set forth herein;
and
WHEREAS, Mallinckrodt currently manufactures and markets Product and is
capable and desirous of undertaking the supply of Product for DAS in accordance
with the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the promises, covenants and
representations of the parties set forth herein, and other good and sufficient
consideration receipt of which is hereby acknowledged, DAS and Mallinckrodt
agree as follows:
1. SUPPLY OF PRODUCT.
(a) For the consideration provided herein and in accordance
with all terms, conditions, representations and warranties
set forth herein, and for the term hereof, Mallinckrodt
will provide DAS with such amounts of Product as DAS shall
request. DAS agrees that it shall purchase at least
[******] of its requirements for Product from Mallinckrodt
hereunder during every Contract Year during the term of
this Agreement. For purposes of the preceding sentence
"Contract Year" shall mean (i) for the first year of this
Agreement, the period beginning on June 9, 2000 and ending
on June 30, 2001, and (ii) for each year thereafter during
the term of this Agreement, the twelve (12) month period
beginning on July 1 and ending on June 30. All Product
supplied hereunder shall be manufactured by Mallinckrodt
strictly in accordance with the Specifications (defined
below) and current Good Manufacturing Practices ("cGMP")
as determined by the United States Food and Drug
Administration ("FDA") using the manufacturing process
described in Mallinckrodt's Drug Master File. If and as
applicable, Mallinckrodt shall comply with the cGMP of
those countries outside the United States represented on
Exhibit B.
(b) The specifications for Product (including, without
limitation, specifications for all components and raw
materials, whether active or inactive) are described on
Exhibit A attached hereto ("Specifications").
(c) Notwithstanding anything to the contrary herein and if,
for any Contract Year after the first Contract Year of
this Agreement, Mallinckrodt is unable to supply DAS with
such quantities of Product as DAS shall order hereunder,
the minimum amount of Product that Mallinckrodt shall be
obligated to supply to DAS in any given Contract Year
thereafter, shall be that amount of Product ordered by DAS
in any such subsequent Contract Year which represents the
[******] sold by Mallinckrodt to all unaffiliated parties
and to other Mallinckrodt business
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
units in such subsequent Contract Year as the [******] in the
immediately previous Contract Year bears to the [******] of all
forms of [******] to all [******] and to [******] business
units in such immediately previous Contract Year.
2. RAW MATERIALS.
Subject to the provisions of Section 4 below, all raw materials and
other resources required in connection with the production of Product
to be supplied hereunder shall be provided by Mallinckrodt [******].
3. QUALITY CONTROL.
(a) Mallinckrodt will take all steps reasonably necessary to ensure
that it has the facilities, equipment, instrumentation, resources
and trained personnel to provide all raw materials, in-process and
product assays, analysis and other testing (including preparing,
submitting and maintaining a foreign Drug Master File for Product
if required by DAS), as compliance with cGMP standards, other FDA
standards, or the standards of the regulatory agencies of European
countries listed in Exhibit B may require in connection with
Mallinckrodt's supply of Product. Mallinckrodt shall provide a
complete certificate of analysis for each lot of Product supplied
hereunder at the time of shipment.
(b) Mallinckrodt shall maintain complete and accurate documentation of
all validation data, stability testing data, batch records,
quality control and laboratory testing and any other data required
under cGMP or other FDA requirements or the requirements of the
regulatory agencies of European countries listed in Exhibit B in
connection with the supply of Product hereunder.
(c) Mallinckrodt warrants that it will not engage in any act which
causes any packaged and labeled Product produced by Mallinckrodt
to become adulterated or misbranded, and agrees that such Product
will not be adulterated or misbranded, within the meaning of the
federal Food, Drug and Cosmetic Act, as amended, when Product is
delivered to DAS.
(d) Mallinckrodt agrees to inform DAS of any significant changes
related to the Product Drug Master File ("DMF") that would
required a NDA supplement from DAS, and Mallinckrodt agrees to
continue to supply unmodified Product to DAS as ordered under the
terms of and subject to the conditions and limitations of this
Agreement for a maximum of two (2) years after DAS is informed in
writing of the new DMF change filing with all applicable
regulatory agencies.
4. COMPENSATION SERVICES PERFORMED BY MALLINCKRODT.
(a) For each kilogram of Product supplied hereunder produced in
accordance with the requirements hereof, DAS shall pay
Mallinckrodt, for Product to
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
be produced and delivered in any particular Contract Year during
the term hereof; as follows (the "Product Price"):
(i) [******]
(ii) [******] and
(iii) [******]; for the sake of clarity, this means that if, for
example, [******]
The Product Price set forth in the immediately preceding
sentence shall be firm through the first Contract Year ending
on June 30, 2001, the date of June 30 (since it is the end of
every Contract Year during the term hereof) being hereinafter
referred to as the "Adjustment Date." From and after the
Adjustment Date, the Product Price shall be adjusted upward or
downward (as the case may be) to reflect actual increases or
decreases in the cost to Mallinckrodt of all raw materials,
directly associated regulatory compliance costs and all
directly allocated labor (all of which costs are hereinafter
referred to at "Product Costs"), in accordance with the
following procedures; provided, however, that if the Product
Price increases in any year by more than [******] Mallinckrodt
agrees that DAS can hire, at its own expense, an independent
third party to audit Mallinckrodt's books and records to
determine whether Mallinckrodt's increase in the Product Price
complies with the terms of this Agreement. Within [******]
prior to the end of each Contract Year hereunder during the
term hereof, Mallinckrodt will notify DAS in writing of the
amount by which its Product Costs hereunder have increased or
decreased during the immediately preceding Contract Year period
and the adjusted Product Price to be charged for the Contract
Year [******] just commenced as a consequence of such increases
or decreases ("Annual Adjustment Notice"). The amount of any
increase or decrease in the Product Price as set forth in any
Annual Adjustment Notice shall be effective for all Product
invoiced by Mallinckrodt to DAS in accordance herewith during
the Contract Year for which such Annual Adjustment Notice is
issued.
(b) At the time of shipment by Mallinckrodt to DAS of any lot of
Product hereunder, Mallinckrodt shall submit to DAS an invoice
setting forth the total amount of Product being shipped to DAS and
the amount due to Mallinckrodt under subscate of analysis and a
certification that the Product for which DAS is being billed has
been produced fully in conformance with applicable Specifications,
cGMP and the requirements hereof. Any such invoice shall be
payable by DAS in United States dollars [******].
5. FORECASTS, ORDER PLACEMENT AND DELIVERY.
(a) Three (3) months prior to anticipated manufacture of Product,
Mallinckrodt will notify DAS in writing of the anticipated
manufacture date. No less than [******] prior to the
anticipated manufacture date that has been provided by
Mallinckrodt to DAS in accordance with the preceding sentence,
[******] (in accordance with the requirements and procedures
hereof) all Product required by DAS for the [******] following
such anticipated manufacture date. DAS may specify that Product
shall be delivered monthly along with the amounts to be so
delivered, or according to any reasonable alternative schedule,
and Mallinckrodt shall deliver Product according to such
schedule and in the quantities specified.
(b) Product shall be ordered by DAS only in writing. Mallinckrodt will
not accept verbal orders of any kind for the production of
Product. Any written work order will contain the following
information: (i) the precise quantity of Product desired and
required delivery dates (consistent with subsection (a) set forth
immediately above), (ii) the anticipated shipping destination for
Product and (iii) such other information as DAS wishes to
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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provide or that Mallinckrodt might find necessary or useful in
completing a specific work order.
(c) Product shall be delivered F.O.B. North American shipping
destination (with the specific destination to be determined by
DAS), freight prepaid by Mallinckrodt, no earlier than three (3)
days prior to the requested delivery date, and no later than the
delivery date. Mallinckrodt will be responsible to make such
arrangements regarding the shipping of Product to designated
destinations as DAS shall reasonably request.
6. ACCEPTANCE AND REJECTIONS AND RECALLS.
(a) If DAS reasonably determines that any Product is defective in
material or workmanship, not in conformance with applicable
Specifications, is adulterated or misbranded, or is otherwise not
in conformity with this Supply Agreement (Product meeting any or
all of such circumstances hereinafter referred to as a "Defective
Product"), then (DAS), in addition to any other rights it may have
under this Supply Agreement, may reject and return any such
Products to Mallinckrodt. At the time of any such rejection, DAS
shall provide Mallinckrodt with a written notice describing in
detail the circumstances surrounding the rejection and DAS'
reasons therefor. If DAS rejects any such Products it will, at
Mallinckrodt's option, either return them to Mallinckrodt or
destroy or dispose of them in the least expensive and most
environmentally sound manner. In any event, Mallinckrodt shall be
responsible for the costs of any such return, destruction or
disposal. It is understood that DAS' sole remedies hereunder in
the event of a Defective Product it has rejected will either be
(i) the replacement by Mallinckrodt of rejected Products that have
either been returned or destroyed with Products that are not
Defective Products or (ii) a full refund of any amount paid
hereunder by DAS for such Defective Products, including all
reasonable transportation and testing costs.
(b) Any Product received by DAS from Mallinckrodt that has not been
rejected by DAS within sixty (60) days after receipt shall be
deemed to have been accepted, except where such Product contains a
nonconformity that was not discovered by DAS after reasonable
inspection, in which case DAS shall have an additional sixty (60)
days after it discovers such nonconformity within which to reject
such Product according to the procedures set forth in Section 6(a)
above.
(c) If DAS reasonably decides to or is required to initiate a product
recall, withdrawal or field correction with respect to, or if
there is any governmental seizure of, its products containing any
Product supplied hereunder which action is due, in whole or in
part, to (i) a failure of any of the Product manufactured by
Mallinckrodt hereunder to conform to applicable Specifications
(including, without limitation, it being
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adulterated or misbranded), or any warranty or other requirement
set forth in this Supply Agreement, (ii) the failure by
Mallinckrodt to comply in all material respects with any
applicable law, rule, regulation, standard, court order or decree
or (iii) the negligent or intentional wrongful act or omission of
Mallinckrodt in connection with the production of Product
hereunder, DAS will notify Mallinckrodt promptly of the details
regarding such action, including providing copies of all relevant
documentation concerning such action. Mallinckrodt will fully
cooperate with and use diligent efforts to assist DAS in
investigating any such situation. All regulatory contacts that are
made and all activities concerning seizure, recall, withdrawal or
field correction will be coordinated by DAS and Mallinckrodt. The
costs of the same shall be apportioned as set forth below.
(d) If any such recall, withdrawal, field correction or seizure occurs
due solely to (i) a failure of any Product sold by Mallinckrodt
hereunder to conform to applicable Specifications (including,
without limitation, it being adulterated or misbranded) or any
warranty or other requirement set forth in this Supply Agreement,
(ii) the failure by Mallinckrodt to comply in all material
respects with any applicable law, rule, regulation, standard,
court order or decree or (iii) the negligent or intentional
wrongful act or omission of Mallinckrodt in connection with the
production of Product hereunder, then Mallinckrodt shall bear the
full cost and expense of any such seizure, recall, withdrawal or
field correction. If any such recall, withdrawal, field correction
or seizure occurs due solely to (i) any pharmaceutical product
manufactured, sold or distributed by DAS that contains Product
failing to conform to its applicable specifications (including,
without limitation, it being adulterated or misbranded) or
otherwise being defective, (ii) the failure of DAS to comply in
all material respects with any applicable law, rule, regulation,
standard, court order or decree or (iii) the negligent or
intentional wrongful act or omission of DAS, then DAS shall bear
the full cost and expense of any such seizure, recall, withdrawal
or field correction, If both Mallinckrodt and DAS contribute to
the cause of a seizure, recall, withdrawal or field correction,
the cost and expenses thereof will be shared in proportion to each
party's contribution to the problem.
7. REGULATORY COMPLIANCE.
(a) Mallinckrodt will comply in all material respects with all
federal, state and local laws, regulations and standards
applicable to production by Mallinckrodt and its performance of
its obligations hereunder, and will also use best efforts to
comply with any applicable laws, regulations and standards of
those European countries set forth on Exhibit B.
(b) Mallinckrodt will promptly furnish DAS with pertinent portions of
all FDA (or other applicable regulatory authority) inspection
reports and
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related correspondence directly related to and affecting its
performance hereunder as and when such reports and correspondence
become available to Mallinckrodt.
(c) Mallinckrodt will notify DAS immediately upon receipt of, and
promptly provide DAS a copy of, the relevant portions of any
warning (including any FDA Form 483), citation, notice,
indictment, claim, lawsuit or proceeding issued or instituted by
any federal, foreign, state or local governmental entity or agency
against Mallinckrodt or any of its affiliates or of any revocation
of any license or permit issued to Mallinckrodt or any of its
affiliates, to the extent that any such occurrence relates to
Mallinckrodt's performance hereunder.
8. CERTAIN REPRESENTATIONS AND WARRANTIES OF MALLINCKRODT.
(a) Mallinckrodt represents and warrants that all Product sold
hereunder will (i) be produced in full compliance with cGMPs
applicable to the Product, and (ii) will meet all Specifications,
and (iii) will have a minimum shelf-life of twenty-four (24)
months after the date of delivery to DAS (i.e., that Product
during the entire shelf-life will comply with the Specifications).
Upon request from DAS, Mallinckrodt will provide to DAS all data
it has collected concerning the shelf-life of the Product beyond
the twenty-four (24) month period referenced above.
(b) Mallinckrodt represents and warrants that there is no claim, suit,
proceeding or investigation pending or, to the knowledge of
Mallinckrodt, threatened against Mallinckrodt or any of its
affiliates which might prevent or interfere with Mallinckrodt's
performance under this Supply Agreement.
(c) Mallinckrodt represents and warrants to DAS that Product sold
hereunder by Mallinckrodt will not be:
(i) in violation of Sections 5 or 12 of the Federal Trade
Commission Act or improperly labeled under applicable
Federal Trade Commission Trade Practice Rules, or other
similar European laws (for the countries set forth on
Exhibit B), as and to the extent applicable hereunder,
(ii) adulterated or misbranded within the meaning of the federal
Food, Drug and Cosmetic Act, as amended, within the meaning
of any regulations of any Regulatory Agency of European
countries listed in Exhibit B or any state or municipal law
in which the definition of adulteration and misbranding are
substantially identical to those contained in the United
States Federal Food, Drug and Cosmetic Act, or articles
which may not under the provisions of Sections 404 or 505 of
said Act be introduced into interstate commerce or which
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may not under similar provisions of any foreign, state or
municipal law be introduced into commerce,
(iii) manufactured or sold in violation of the federal Controlled
Substances Act, as amended, or any substantially similar
legislation of applicable European country (for the
countries set forth on Exhibit B) or state law,
(iv) manufactured or sold in violation of any of the provisions
of the Fair Labor Standards Act of 1938, as amended,
(v) manufactured or sold in violation of The Occupational Safety
and Health Act of 1970, as amended,
(vi) manufactured in violation of any applicable federal, state
or local environmental law or regulation, or
(vii) manufactured in violation of any agreement (commercial or
otherwise), judgment, order or decree to which Mallinckrodt
is a party.
(d) Mallinckrodt certifies that neither it nor any of its affiliates
nor any member of their staff has been disqualified or debarred by
the FDA, or any other domestic regulatory authority, or any other
applicable regulatory agency of any of the European countries set
forth in Exhibit B for any purpose.
(e) Mallinckrodt warrants and represents that neither it nor any of
its affiliates nor any member of their staff have been charged
with or convicted under federal law, or other applicable laws of
the European countries set forth in Exhibit B, for conduct
relating to the development or approval, or otherwise relating to
the regulation of any drug product under the Generic Drug
Enforcement Act of 1992 or any other relevant statute, law or
regulation.
(f) Mallinckrodt hereby represents and warrants that: Mallinckrodt has
all rights and licenses necessary to manufacture and sell the
Product to DAS.
(g) EXCEPT AS SET FORTH ABOVE IN THIS SECTION 8, MALLINCKRODT MAKES NO
OTHER WARRANTY OR REPRESENTATION, EXPRESS OR IMPLIED, CONCERNING
ITS PERFORMANCE HEREUNDER, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT
TO "PRODUCT." UNDER NO CIRCUMSTANCES WILL MALLINCKRODT BE LIABLE
HEREUNDER FOR CONSEQUENTIAL, INDIRECT, EXEMPLARY OR SPECIAL
DAMAGES OF ANY KIND (INCLUDING, WITHOUT LIMITATION, LOST PROFITS),
WHETHER OR NOT IN ANY PARTICULAR
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CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CIRCUMSTANCE SUCH DAMAGES ARE FORESEEABLE AND WHETHER OR NOT
MALLINCKRODT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
9. FACILITY ACCESS.
DAS, through its employees, consultants or other representatives will
have the right during normal business hours and at a time mutually
agreed to inspect Mallinckrodt's manufacturing operations to determine
whether or not Mallinckrodt is complying in all respects with its
obligations hereunder. DAS warrants that all such inspections and
audits shall be carried out in a manner calculated not to unreasonably
interfere with Mallinckrodt's conduct of business and to insure the
continued confidentiality of Mallinckrodt's business and technical
information. Further, DAS agrees to comply with all of Mallinckrodt's
safety and security requirements during any visits to the Mallinckrodt
facilities. Following an inspection which will in any way affect the
production of Product for supply to DAS by the FDA or any other
European Community authority (as set forth on Exhibit B), Mallinckrodt
will notify DAS in writing of any material issues that may be pertinent
to the supply of Product to DAS. The parties agree to cooperate in good
faith and engage in an active dialogue in an effort to resolve any
issues resulting from any such inspections.
10. FORCE MAJEURE.
Neither party to this Supply Agreement shall be liable for or be in
breach of any provision hereof for any failure or delay on its part to
perform any obligation (other then the obligation to make payments when
due) under any provision of this Supply Agreement because of an event
of "force majeure," including, but not limited to, any act of God,
fire, flood, explosion, unusually severe weather, war, insurrection,
riot, sabotage, labor unrest, strikes or work stoppages or any other
cause whatsoever, whether similar or dissimilar to those enumerated
herein, beyond any reasonable possibility of control of such party, if
and only if the party affected shall have used all reasonable efforts
under the circumstances to avoid such occurrence and to remedy it
promptly if it shall have occurred. If an event of force majeure
causes a failure or delay in performance hereunder by Mallinckrodt
for more than one hundred eighty (180) continuous days, DAS, at its
option, may (i) terminate this Supply Agreement effective upon
written notice to Mallinckrodt or (ii) may extend the delivery or
performance period by the amount of time during which such delivery
or performance was omitted or delayed.
11. RELATIONSHIP OF PARTIES.
For all purposes hereof, Mallinckrodt shall be deemed to be an
independent contractor and this Supply Agreement shall not create an
agency, partnership, joint venture, or employer/employee relationship
between DAS and Mallinckrodt, and nothing hereunder shall be deemed to
authorize either party hereto to act for, represent or bind the other
or any of its affiliates except as expressly provided in this Supply
Agreement.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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12. CONFIDENTIALITY.
(a) DAS and Mallinckrodt shall maintain in confidence and not use or
disclose to any third party, except as is specifically
contemplated herein or is otherwise necessary to perform their
respective obligations under this Supply Agreement, and then only
on a confidential basis satisfactory to both parties, any
information, including without limitation business and technical
information, experience or data regarding any facility, programs,
laboratories, processes, products, costs, equipment operation or
customers, relating to the manufacture or sale of Product
hereunder. The foregoing obligations of confidentiality and
non-use shall survive the termination or expiration of this Supply
Agreement for a period of five (5) years. Nothing herein shall
prevent either party from disclosing any information required by
statute or governmental regulations to be disclosed in a judicial
or administrative proceeding, after the disclosing party has been
given a reasonable opportunity, to the extent possible, to pursue
all legal remedies for maintaining such information in confidence,
or from using information which (i) has been published or has
become part of the public domain other than by acts, omissions or
fault of such party, (ii) was lawfully received by such party from
a third party free of any obligation of confidence to such third
party, (iii) or a party can demonstrate from its records was
already in its possession prior to receipt thereof, directly or
indirectly, from the other party. The party asserting the
applicability of one of the exclusions from the obligation of
confidentiality set forth in the immediately preceding sentence
shall have the burden of proving the applicability of any such
exclusion in any particular circumstance.
(b) Each party acknowledges that any breach by it of the
confidentiality obligations set forth in this Section 12 would
cause the other party irreparable harm for which compensation by
monetary damages would be inadequate and, therefore, the party
that has been harmed by any such breach shall have the right to an
injunction or decree for specific performance, in addition to any
other rights and remedies such party may have at law or in equity.
(c) Upon any termination of this Agreement, each recipient party will
promptly return or destroy, at the discretion of the disclosing
party, any confidential information of the disclosing party.
13. INDEMNIFICATION.
(a) Subject to the provisions of Section 8(g) hereof, Mallinckrodt (on
behalf of itself and its affiliates) hereby agrees to indemnify,
defend and hold harmless DAS and its affiliates from and against
any and all demands, claims, actions, causes of action,
assessments, losses, damages, injuries, liabilities, costs and
expenses, including without limitation, interest, penalties and
reasonable attorneys' fees and expenses (collectively
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CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
"Damages") asserted against, resulting to, imposed upon or
incurred by DAS or its affiliates, directly or indirectly related
to, arising out of or resulting from:
(i) any breach or failure of any of the representations,
warranties and covenants of Mallinckrodt contained herein,
including (without limitation) any breach or failure by
Mallinckrodt to perform any obligations contained herein,
and
(ii) any failure of Mallinckrodt to observe or comply in all
material respects with any laws, rules or regulations for
which and to the extent Mallinckrodt has promised compliance
hereunder.
(b) DAS hereby agrees to indemnify, defend and hold harmless
Mallinckrodt and any of its affiliates from and against any and
all Damages asserted against, resulting to, imposed upon or
incurred by Mallinckrodt, directly or indirectly related to,
arising out of or resulting from:
(i) any breach or failure of any of the representations,
warranties and covenants of DAS contained herein,
(ii) any failure of DAS to observe or comply in all material
respects with any laws, rules or regulations directly
related to DAS' performance hereunder, and
(iii) DAS' or DAS' agents', distributors' or customers' use,
processing, transportation possession, disposal or sale of
any dosage Product manufactured by DAS, and whether used
alone or in combination with any other material.
(c) In the event of any claim being made against a party (the
"Indemnified Party"), which triggers the indemnity obligations of
the other party (the "Indemnifying Party") as set forth above,
such indemnification shall be conditioned on compliance with the
procedure outlined below. Provided that prompt notice is given of
any claim or suit, the Indemnifying Party shall have the right to
defend, contest, or otherwise protect against any such claim or
suit, including by way of settlement and release, at its own
expense and cost. The Indemnifying Party shall be entitled to sole
control of the defense and settlement of any such claim or suit,
and the Indemnified Party shall cooperate and provide such
assistance as the Indemnifying Party may reasonably request in
connection with the defense of the matter subject to
indemnification.
14. TERM AND TERMINATION.
(a) Unless sooner terminated in accordance herewith, the initial
term of this Supply Agreement shall be for a period commencing
on June 9, 2000 and ending June 30, 2005, and shall
automatically be renewed for additional one (1) year terms
thereafter unless either party shall give written notice to the
other, at least six (6) months prior to the end of the initial
term or any renewal term, that it does not wish the Supply
Agreement to be renewed for an additional one (1) year period.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(b) In addition to any other right of termination specifically
provided for hereunder, this Supply Agreement may be terminated by
either party for cause upon written notice to the other. For
purposes of the preceding sentence, "cause" shall mean (without
limitation):
(i) any material breach of this Agreement by a party which shall
go uncorrected for a period of thirty (30) days after
written notice of such breach has been given to the
defaulting party,
(ii) the institution by a party of voluntary proceedings in
bankruptcy or under any insolvency law or law for the relief
of debtors,
(iii) the making by a party of an assignment for the benefit of
creditors or any dissolution or liquidation,
(iv) the filing of an involuntary petition under any bankruptcy
or insolvency law against a party, unless such petition is
dismissed or set aside within sixty (60) days from the of
its filing, or
(v) the appointment of a receiver or trustee for the assets or
business of a party, unless such appointment is dismissed or
set aside within sixty (60) days from the date of such
appointment.
(c) The representations and warranties of the parties hereunder,
covenants which by their terms have effect after the termination
or expiration hereof, and the parties' indemnification and
confidentiality obligations shall survive termination or
expiration of this Supply Agreement.
(d) In the event of any termination or expiration of this Supply
Agreement, for any reason, Mallinckrodt shall (i) notwithstanding
the effective date of any termination or the expiration, as the
case may be, complete any orders for Product that were made by DAS
and accepted by Mallinckrodt prior to such date, and DAS shall pay
Mallinckrodt for any Product produced in accordance with such
orders at the then applicable Product Price in effect on the
effective date of termination hereunder or expiration (as the case
may be). No less than thirty (30) days prior to the effective
date of termination or expiration (as the case may be), DAS
shall have the option to place an estimated order (+/- 20%) for
all Product required for the twelve (12) month period following
the effective date of termination or expiration (as the case
may be) to be shipped according to Section 5c; provided that,
Mallinckrodt shall not be required to accept all or any portion
of such orders in the event this agreement has been terminated
by Mallinckrodt pursuant to Section 14(b).
15. REMEDIES CUMULATIVE.
The remedies provided in this Supply Agreement shall be cumulative and
shall not preclude assertion by any party hereto of any other rights
(whether legal or equitable in nature) or the seeking of any other
remedies against party other party hereto.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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16. BINDING EFFECT AND ASSIGNMENT.
This Supply Agreement shall inure to the benefit of and be binding upon
the parties hereto, their successors and assigns; provided, however,
that neither party shall, without the prior written consent of the
other party, assign or transfer any of its rights, benefits,
obligations, or other interest under this Supply Agreement to any other
party, except that, without seeking consent of the other party, either
party may assign this Supply Agreement to any entity or person it
controls, it is controlled by or is under common control with, or to
any entity or person that acquires all or substantially all of its
stock, assets or business or acquires that portion of its business to
which this Supply Agreement relates, whether by merger, acquisition,
sale or otherwise.
17. NOTICE.
All notices, consents, approvals or other notifications required to be
sent by one party to the other party hereunder shall be in writing and
shall be deemed served upon the other party if delivered by hand or
sent by United States registered or certified mail, postage prepaid,
with return receipt requested, or by facsimile, or air courier,
addressed to such other party at the address set out below, or the last
address of such party as shall have been communicated to the other
party. If a party changes its address, written notice shall be given
promptly to the other party of the new address. Notice shall be deemed
given on the day it is sent (in the case of delivery by method other
than hand delivery) or the date of delivery (in the case of delivery by
hand) in accordance with the provisions of this paragraph. The
addresses for notices are as follows:
If to Mallinckrodt:
Mallinckrodt Inc.
c/o Pharmaceuticals Group
675 McDonnell Boulevard
Hazelwood, Missouri 63042
Attn: Pat E. Cunningham
Vice President Pharmaceuticals Group
with a copy to:
Mallinckrodt Inc.
675 McDonnell Boulevard
Hazelwood, Missouri 63042
Attn: C. Stephen Kriegh
Staff Vice President
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If to DAS:
DrugAbuse Sciences
330 Distel Circle, Suite 150
Los Altos, CA 94022
Attn: Philippe Pouletty,
Chairman and Chief Executive Officer
Telephone: (650) 417-2300
Fax: (650) 417-2400
18. GOVERNING LAW AND JURISDICTION.
This Agreement shall be governed by and construed in accordance with
the substantive and procedural laws (as opposed to the conflicts of law
provisions) of the State of New York.
19. WAIVER.
The failure by any party to exercise any of its rights hereunder or to
enforce any of the terms or conditions of this Supply Agreement on any
occasion shall not constitute or be deemed a waiver of that party's
rights thereafter to exercise any rights hereunder or to enforce each
and every term and condition of this Supply Agreement.
20. MODIFICATIONS.
This Supply Agreement may not be amended or modified except by a
writing specifically referring to this Supply Agreement and executed by
duly authorized representatives of both parties. The obligations of the
parties are governed by the terms and conditions of this Supply
Agreement and none of the general terms and conditions of any DAS
purchase order or any Mallinckrodt acknowledgment or any substantially
similar documents of either party will in any case be controlling or
supersede the provisions hereof.
21. SEVERABILITY.
A determination that any portion of this Supply Agreement is
unenforceable or invalid shall not affect the enforceability or
validity of any of the remaining portions hereof or of this Supply
Agreement as a whole. In the event that any part of any of the
covenants, sections or provisions herein may be determined by a court
of law or equity to be overly broad or against applicable precedent or
public policy, thereby making such covenants, sections or provisions
invalid or unenforceable, the parties shall attempt to reach agreement
with respect to a valid and enforceable substitute for the deleted
provisions, which shall be as close in its intent and effect as
possible to the deleted portions.
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22. HEADINGS.
The parties agree that the section and article headings are inserted
only for ease of reference, shall not be construed as part of this
Supply Agreement, and shall have no effect upon the construction or
interpretation of any part hereof.
23. COUNTERPARTS.
This Supply Agreement may be executed in several counterparts, and each
executed counterpart shall be considered an original of this Supply
Agreement.
24. ENTIRE AGREEMENT.
This Supply Agreement represents the entire agreement and understanding
of the parties hereto with respect to its subject matter and supersedes
any and all prior agreements, understanding or discussions, whether
written or oral, between the parties.
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IN WITNESS WHEREOF, the parties hereto have caused this Supply
Agreement to be executed as of the day and year first above written.
MALLINCKRODT INC.
DRUGABUSE SCIENCES, INC. Pharmaceuticals Group
By: /s/ Philippe Pouletty By: /s/ Pat E. Cunningham
---------------------------------- ---------------------------------
Name Printed: Philippe Pouletty, M.D. Pat E. Cunningham
Title Printed: Chairman and CEO Vice President, Pharmaceuticals Group
Date: June 8, 2000 Date: June 8, 2000
<PAGE>
EXHIBIT A
PRODUCT SPECIFICATIONS
NALTREXONE BASE ANHYDROUS
ITEM CODE: [******]
FORMULA: [******]
CAS REGISTRY No.: [******]
MOLECLLNIZ WEIGHT: [******]
APPEARANCE: [******]
IDENTIFICATION: [******]
WATER CONTENT: [******]
TITRATION ASSAY: [******]
HEAVY METALS: [******]
RELATED SUBSTANCES: [******]
[******] [******] [******] [******]
[******]
HPLC ASSAY: [******]
BIO-BURDEN/ENDOTOXIN LIMITS:
DrugAbuse Sciences as part of our
scale up and R&D efforts will be
determining [******]. These limits
will be based on the process and
agreed upon by the parties at a
later date.
<PAGE>
EXHIBIT B
EUROPEAN COUNTRIES
France
Germany
Italy
Netherlands
Norway
Portugal
Spain
Sweden
Switzerland
United Kingdom