EXHIBIT 10.16
SUPPLY AGREEMENT FOR BULK NARCOTICS RAW MATERIALS
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MALLINCKRODT INC., St. Louis, Missouri ("SELLER") agrees to sell to ENDO
PHARMACEUTICALS, INC., Chadds Ford, Pennsylvania ("BUYER"), and BUYER agrees to
buy from SELLER, products as listed in Attachment "A" in bulk under the terms
and conditions of this Agreement.
1. DEFINITIONS
A. "Affiliate" means any business entity which, directly or indirectly,
is controlled by BUYER or SELLER, as the case may be.
B. "BUYER" shall mean and include all of the subsidiaries and Affiliates
of BUYER, wherever located and however denominated.
C. "Confidential and Proprietary Information" means information relating
to the manufacture of the PRODUCTS and the marketing of them in final
dosage forms for all indications.
D. "Effective Date" means July 1, 1998.
E. "PRODUCTS" means narcotic active drug substances or raw materials as
listed in Attachment "A" in bulk as further defined in the Product
specifications set forth in Attachment "B" to this Agreement.
2. UNDERTAKING/QUANTITY
In each year during the term of this Agreement (beginning with the year
commencing July 1, 2003 and ending June 30, 2013), SELLER will manufacture and
supply to BUYER up to one hundred percent (100%) of BUYER's annual requirement
of PRODUCTS as follows:
A. BUYER will purchase from SELLER no less than seventy-five percent (75%)
of BUYER's annual requirements of each of *** and any additional
products which BUYER and SELLER agree to designate as PRODUCTS (as
discussed in Article 2.E. below).
B. BUYER will purchase from SELLER no less than ninety-five percent (95%)
of BUYER's annual requirements of ***.
C. *** shall become a PRODUCT under this Agreement only after
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 ***.
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BUYER has completed qualification of SELLER's PRODUCT for BUYER's
finished products and SELLER is able to routinely manufacture this
PRODUCT according to an approved Drug Master File and according to
BUYER's specifications as set forth in Attachment "B".
D. SELLER and BUYER may add additional PRODUCTS to this Agreement by
mutual written consent. Unless otherwise agreed, the provisions of
Article 2.A. above shall apply to all such additional PRODUCTS.
Either party may initiate the addition of other PRODUCTS.
E. Purchase requirements shall be determined by reference to BUYER's
requirements as measured by weight.
3. PRICE
A. The price for PRODUCTS will be as set forth in Attachment "A",
attached hereto and forming a part hereof.
B. If during the term of this Agreement SELLER sells or offers for sale
to any independent third party PRODUCT (other than samples of 2 kg or
less for research purposes) at prices lower than the then effective
prices hereunder, for the same or lesser volumes, SELLER shall make
such lower prices available to BUYER as soon as and for so long as the
lower prices continue to be offered by SELLER to any third party.
SELLER has an affirmative obligation to inform BUYER of sales or
offers to sell to any third party at prices below the prices then
effective under this Agreement.
C. If during the term of this Agreement any government of a country in
which BUYER sells a dosage form of PRODUCT establishes a maximum price
for any such dosage form, SELLER and BUYER shall meet to discuss a
mutually acceptable solution to BUYER's market needs on the basis of
documented evidence. In addition, the parties agree that should
unanticipated or changed commercial or regulatory conditions cause
either or both parties to experience economic hardship in connection
with the performance of its or their obligations under the terms of
this Agreement, the parties will meet and negotiate in good faith an
equitable resolution of that hardship.
D. Notwithstanding anything herein to the contrary, BUYER shall not be
required to pay a purchase price for any PRODUCT which is greater than
*** of Seller's book price (i.e.,
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*** of the price set forth in SELLER's published price list as of the
date the corresponding purchase order is received).
4. TERM
This Agreement shall commence on July 1, 1998, shall continue in effect
until June 30, 2013, and shall be automatically renewed thereafter for
successive one (1) year periods unless either party shall provide written notice
to the other party of its intent to terminate at least two (2) years prior to
the end of the term which such notice indicates shall be the final term of this
Agreement.
5. FORECASTS/INVENTORY
A. On ***, BUYER shall provide SELLER with a firm order for *** and ***,
to be delivered by SELLER to BUYER within the *** period following
submittal of such order. Thereafter, on every *** and *** during the
term of this Agreement, BUYER shall provide SELLER with a firm order
for deliveries of PRODUCTS within the *** period beginning *** after
submittal of such order. The intent of this provision is to ensure that
SELLER, upon receipt of each firm order, shall have firm orders from
BUYER which collectively identify BUYER's purchases of such PRODUCTS
for delivery during the *** period following submittal of such order.
In addition, at the time each such firm order is submitted, BUYER shall
also submit to SELLER a forecast (for planning purposes only) of
BUYER's purchases hereunder which are to be delivered by SELLER to
BUYER within the *** period following such submittal. The first ***
of such forecast should correspond to the purchases to be delivered to
BUYER during such period under the firm orders which BUYER shall have
submitted to SELLER. Firm orders and forecasts due from BUYER on a date
falling on a weekend or holiday will be deemed timely submitted if
delivered on the next business day following the due date.
B. Beginning on *** and every *** thereafter during the term
hereof, BUYER shall provide SELLER with a firm order for ***. Such firm
order shall be for PRODUCTS which are to be delivered by SELLER to
BUYER within the three-month period beginning with receipt of such
order. At the
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same time, BUYER shall deliver to SELLER a forecast (for planning
purposes only) of BUYER's purchases hereunder to be delivered within
the *** period following submittal of such forecast. The first *** of
such forecast shall correspond to the purchases to be delivered to
BUYER during such period under the firm order which BUYER shall have
submitted to SELLER.
C. In the event any forecast of BUYER is more than *** the previous
forecast and such forecasted amount is in excess of SELLER's production
capacity, BUYER and SELLER shall discuss and agree upon a mutually
acceptable delivery schedule for PRODUCTS to permit SELLER to meet
BUYER's requirements in a timely manner if possible. SELLER will make
all reasonable efforts to deliver PRODUCTS at the times and in the
quantities requested by BUYER.
D. BUYER must take delivery on the scheduled delivery date (as set forth
in the firm order) of all PRODUCTS ordered pursuant to a firm order. By
providing written notice to SELLER not less than *** days prior to the
scheduled delivery date, BUYER may increase or decrease its firm order
quantities of PRODUCTS (excluding ***) by as much as ***. SELLER's
written approval shall be required if BUYER wishes to increase or
decrease quantities under any of the following conditions: (i) any
change with respect to orders for *** and ***, (ii) a change of *** or
less with respect to orders for any other PRODUCT if BUYER's quantity
change request is not timely made, and (iii) any change exceeding ***.
BUYER can alter scheduled delivery dates only with SELLER's prior
approval. SELLER can adjust its shipping quantities only with BUYER's
prior approval. Purchase change orders will be issued and executed as
appropriate in connection with such quantity and schedule changes.
6. SHIPMENT
SELLER shall ship PRODUCTS in accordance with BUYER's packaging and labeling
requirements and in accordance with BUYER's firm orders FOB destination ***, or
other location of BUYER specified by BUYER. If the delivery point is other than
***, BUYER will notify SELLER at least thirty (30) days in advance of scheduled
delivery date. BUYER shall reimburse SELLER for any additional freight, taxes,
duties or other expenses due to shipment to any location outside the United
States (other than ***).
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7. PAYMENT TERMS
SELLER shall invoice BUYER upon shipment for PRODUCTS delivered hereunder.
BUYER shall make payment net *** days from receipt of ordered PRODUCTS and
correct invoice.
8. CONFIDENTIAL AND PROPRIETARY INFORMATION
The treatment of Confidential and Proprietary Information (including the
fact that this Agreement exists) previously exchanged by the parties and to be
exchanged during the term of this Agreement shall be governed by the terms of
the Confidentiality Agreement attached hereto as Attachment C and made a part
hereof.
9. ANALYSIS AND INSPECTION
A. Promptly upon receipt, SELLER will analyze each lot of PRODUCTS for
compliance with specifications. SELLER will send *** prior to or along
with shipment of each lot of PRODUCTS. If any other documentation is
reasonably necessary for BUYER to perform a quality assurance analysis
of the PRODUCTS, BUYER and/or BUYER's duly designated agent will
request that documentation in writing and SELLER will provide it, if it
is reasonably available.
B. BUYER and/or BUYER's duly designated agent will inspect all shipments
upon their receipt and will report any reasonably discernible defects
in the PRODUCTS to SELLER within *** days of receipt of the PRODUCTS
and related records. Any defects not reasonably discernible will be
reported to SELLER by BUYER and/or BUYER's duly designated agent within
*** days of BUYER's and/or BUYER's duly designated agent's discovery of
same. If any PRODUCT does not meet the specifications and warranties in
this Agreement or is otherwise defective and is reported to SELLER by
BUYER and/or BUYER's duly designated agent within the applicable time
period set forth above, BUYER may reject the PRODUCT and return it to
SELLER or destroy it as directed by SELLER. BUYER will not be liable
for payment for rejected PRODUCTS. SELLER will not be liable for any
consequential or other damages related to any non-conforming PRODUCTS
rejected by BUYER.
C. If BUYER and/or BUYER's duly designated agent notifies SELLER in
writing that
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PRODUCTS do not meet specifications and warranties as determined by
BUYER's and/or BUYER's duly designated agent's testing and inspection
of the PRODUCTS, and if SELLER agrees, SELLER's liability and BUYER's
remedy in such circumstances will be limited as set forth in Article 15
below.
D. In the event of any disagreement between SELLER and BUYER relating to
any PRODUCT alleged not to conform to specifications, the parties will
confer to determine the appropriate and mutually agreeable plan to
resolve the disagreement, which may include the use of an independent
analyst, agreeable to both parties. If an independent analyst is called
upon by the parties to test the PRODUCT in question, the findings of
such analyst shall be binding upon both parties. Such analyst shall not
divulge his findings to any person other than the parties hereto. The
expenses incurred in this independent analysis shall be equally shared
between the parties hereto. If it is determined as a result of such
analysis that any PRODUCTS do not meet applicable specifications and
warranties, SELLER's liability and BUYER's remedy therefor will be
limited as set forth in Article 15 below.
E. Without limiting Mallinckrodt's discretion in other situations, the
parties agree that Mallinckrodt shall be entitled, in its absolute
discretion, to refuse to agree to a specification change because ***.
10. FORCE MAJEURE
A. Either party shall be excused from nonperformance or delay in
performance, and the time of any performance will be extended to the
extent reasonably necessary under the circumstances, to the extent that
such nonperformance or delay in performance is caused by circumstances
beyond the reasonable control of the party affected ("Force Majeure").
Without limitation, the term "Force Majeure" shall include promulgation
of international or U.S. governmental regulations, including under the
U.S. Federal Food, Drug and Cosmetic Act, which make it impractical for
BUYER to use any PRODUCT. The affected party shall promptly notify the
other party of the Force Majeure circumstances and their probable
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duration. If the Force Majeure lasts for more than nine (9) months, the
notified party may immediately thereafter terminate this Agreement by
written notice (but only as it applies to the PRODUCT(S) affected by
the Force Majeure).
B. A party whose performance has been excused in accordance with paragraph
"A" immediately above will perform such obligations as soon as is
reasonably practicable after the termination or cessation of the Force
Majeure, unless this Agreement has already been terminated with respect
to the PRODUCT(S) affected by the Force Majeure.
11. MANUFACTURING STANDARDS
A. SELLER will manufacture PRODUCTS in compliance with current Good
Manufacturing Practices (cGMP), according to its "Standard Operating
Procedures" for each PRODUCT and FDA Guidelines as applied to bulk
pharmaceutical chemicals as regulated by the U.S. Food and Drug
Administration (FDA).
B. SELLER will complete concurrent validation of its chemical processes
methods and equipment used in the manufacture, packaging, storage,
testing and release of PRODUCTS in conformance with all current FDA
regulations as applicable to Products, and review such validation
annually and through effective change control procedures assure that
the validation is kept current.
C. SELLER will retain under proper storage conditions such samples of
PRODUCTS as are required to comply with the stability sections of its
Drug Master Files ("DMF"), but not less than the amount needed to
perform two complete sets of testing. (BUYER shall require copies of
all test specifications and methods as well as analytical methods
validation documentation for BUYER's files). Analysis of stability
samples must be completed within *** days of the sample pull
date.
D. SELLER will maintain its DMF in compliance with FDA regulations and
update its DMF to cite any additional references thereto in any
amendments that may be made to BUYER's New Drug Application ("NDA"),
abbreviated New Drug Application ("ANDA") or accompanying supplements.
E. SELLER will manufacture PRODUCT according to the filed DMF. SELLER will
notify BUYER of any and all pertinent changes in its production,
testing or packaging procedures in the DMF-documented process as
required by FDA "Guidelines for Drug Master Files"
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Section VII A and the parties agree to discuss in good faith the impact
of such changes on both the BUYER and the SELLER. Written notification
from SELLER to BUYER of such changes shall be given not less than ***
prior to the intended change implementation. If requested by BUYER,
SELLER shall provide BUYER with a sample of PRODUCT produced using the
proposed manufacturing change. SELLER shall provide BUYER with
sufficient information to allow BUYER to assess the effect any changes
might have on quality, safety or regulatory compliance; provided,
however, that SELLER shall not be required to divulge any proprietary
information to BUYER. ***.
F. BUYER shall be able to propose changes in specifications of PRODUCTS
which BUYER desires for end-use performance of existing or new dosage
forms containing PRODUCTS and, such changes shall be implemented only
if SELLER agrees and so long as such change can be made within SELLER's
then current DMF. ***.
If changes in either or both parties' manufacturing, specifications,
testing or packaging are required as the result of governmental action
or edict, each party will, in general, cover its own expenses for such
changes. However, in the event that any such changes affects one party
significantly more than the other, the parties agree to negotiate in
good faith to more equitably balance the hardship between the parties
(see Article 3.C.).
G. Records which include the information relating to the manufacturing,
packaging and quality operation for each lot of PRODUCTS will be
prepared by SELLER at the time such operations occur. The records will
include, but not be limited to: mixing and filling records, container
and component traceability records, equipment usage records, in-process
and final laboratory testing results, in-process and final PRODUCT
physical inspection results, yield reconciliation for PRODUCTS,
labeling and packaging records, and records relating to deviations from
procedure as well as SELLER's investigations and corrective
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actions regarding same.
H. SELLER will conduct stability studies as necessary to support the DMF
for PRODUCTS. A minimum of *** per year, or if a PRODUCT is produced
less frequently than once per year, each production lot, shall be
stored at the labeled storage condition and tested as described in the
SELLER's stability protocol filed in the SELLER's PRODUCT Drug Master
File.
I. SELLER will retain records and documents for periods meeting all
applicable regulations of the FDA and other regulatory agencies.
J. In case of an out of specification result, or if assay values fall out
of established stability alert limits, SELLER will inform BUYER
promptly and SELLER will conduct an investigation and perform
corrective action as required by cGMP's. Reports shall become part of
SELLER's batch records for the FDA.
K. SELLER will assure that *** PRODUCTS or PRODUCTS containing *** will
not be received, stored, handled, dispensed, manufactured or packaged
in the same facility(ies) or in facilities that share a common heating,
ventilation and air conditioning systems or utilize the same equipment
in the manufacture or handling of the components, raw materials or
packaging as PRODUCTS.
12. AUDITS
A. SELLER will promptly inform BUYER of any audits and inspections by any
governmental agency relating to its PRODUCT process and provide copies
to BUYER of inspection observation reports (483s) and SELLER's
responses that may affect the PRODUCT process adversely.
B. SELLER will permit the duly authorized representative of BUYER to visit
and conduct GMP inspections of the production and testing facilities
for PRODUCTS during normal business hours and shall reasonably
cooperate with such inspections; provided, however, that BUYER shall
first give SELLER reasonable notice of any such intended visit and
shall execute a confidentiality agreement reasonably satisfactory to
SELLER.
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13. COMPLAINTS, XXXX'X & RECALLS
A. BUYER will correspond with complainants on all complaints associated
with finished products made from PRODUCTS. SELLER will assist BUYER in
investigating such complaints by analyzing PRODUCTS to determine if
they meet applicable specifications and the manufacturing standards
referred to in Article 11 above.
B. BUYER will file any Adverse Drug Experience Reports (XXXX'x) required
under 21 CFR 314.80 and foreign laws or regulations for PRODUCTS.
SELLER will notify BUYER by fax of all PRODUCT complaints and Adverse
Drug Experiences ("ADE's") received within two (2) days of receipt,
including but not limited to serious or unexpected ADE's and PRODUCT
complaints which may require an FDA Field Alert Report as specified
under 21 CFR 314.81. Such notice to BUYER will be sent to:
Endo Pharmaceuticals, Inc.
Fax number (000) 000-0000
C. If BUYER should decide or be required to initiate a PRODUCT recall,
withdrawal or field correction because of (i) supply by SELLER of
PRODUCT that does not conform to the warranties in this agreement or
(ii) the negligent or intentional wrongful act or omission of SELLER,
BUYER will notify SELLER and provide SELLER a copy of its recall letter
prior to initiation of the recall. SELLER will assist BUYER in the
investigation to determine the cause and extent of the problem. All FDA
or foreign regulatory authority contacts and coordination of any recall
activities will be accomplished by cooperation of BUYER and SELLER;
SELLER shall coordinate recall of PRODUCTS and BUYER shall coordinate
recall of its finished products.
D. If any PRODUCT or PRODUCT in dosage form is recalled solely as a result
of (i) supply by SELLER of PRODUCT that does not conform to the
warranties in this Agreement or (ii) the negligent or intentional
wrongful act or omission of SELLER, then SELLER will bear all costs and
expenses of such recall. If any PRODUCT in dosage form is recalled as a
result of (a) handling or storage of PRODUCT by BUYER or manufacture of
dosage form by BUYER or (b) the negligent or intentional wrongful act
or omission of BUYER, then BUYER will bear all costs and expenses of
such recall. If each party contributes to the cause of a recall, the
cost will be shared in proportion to each party's contribution.
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E. For all PRODUCTS supplied to BUYER by SELLER under this Agreement,
SELLER will maintain complete and accurate records for such periods
after the date of manufacture as may be required by applicable law or
regulation, but not less than three (3) years.
F. BUYER will inform SELLER of any and all regulatory issues that may
affect SELLER's manufacture of PRODUCTS or the marketability of the
dosage forms promptly after learning of such issues.
14. ADDITIONAL REPRESENTATION AND WARRANTIES
A. Provided that PRODUCTS are stored according to labeling approved by the
FDA, SELLER warrants that PRODUCTS delivered to BUYER, from date of
delivery to date of expiration (as specified on such labeling), (i)
will not be adulterated, misbranded, or otherwise prohibited from sale
within the meaning of the Federal Food, Drug and Cosmetic Act ("the
Act") or any state or local law, (ii) will be free from defects in
materials and bulk manufacture, and (iii) will conform to the PRODUCTS
specifications set forth in Attachment B.
B. Each of BUYER and SELLER warrants that it will not cause any individual
or firm debarred by the FDA to participate in the performance,
supervision, management or review of the PRODUCTS.
C. Each of BUYER and SELLER will abide by the policy of the United States
regarding maximum opportunity for small business concerns owned and
controlled by socially and economically disadvantaged individuals.
D. Each of BUYER and SELLER warrants that it will comply with all
applicable laws, rules, orders and regulations covering services
specified herein, including but not limited to Executive Order 111246
(and the rules and regulations promulgated thereunder), the Fair Labor
Standards Act of 1938, as amended, the Rehabilitation Act of 1973 and
the Vietnam Era Veterans Readjustment Act of 1974.
E. Each of BUYER and SELLER warrants that it will comply with all federal,
state and local statutes, regulations and governmental orders and
actions applicable to or related to the use, possession, handling,
transportation, sale or disposal of PRODUCTS. It is understood that
BUYER alone accepts full responsibility for such compliance relative to
the use, possession, transportation, sale or disposal of any of its
dosage forms, and SELLER shall
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have absolutely no responsibility or liability therefor.
F. THE WARRANTIES OF SELLER SET FORTH SPECIFICALLY IN THIS AGREEMENT ARE
EXCLUSIVE AND ARE IN LIEU OF ANY AND ALL OTHER WARRANTIES AND/OR
REPRESENTATIONS, WHETHER EXPRESS OR IMPLIED, ARISING BY OPERATION OF
LAW, TRADE USAGE OR CUSTOM OR OTHERWISE. SELLER EXPRESSLY DISCLAIMS ANY
AND ALL EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY AND/OR FITNESS
FOR A PARTICULAR PURPOSE OR USE, EVEN IF ADVISED OF THE POSSIBILITY OF
CLAIMS BASED ON SUCH WARRANTIES.
15. LIMITATION OF LIABILITY BETWEEN SELLER AND BUYER
Promptly upon receipt of each shipment of PRODUCTS, BUYER shall examine
such shipment for damage, defect, or shortage. All claims by BUYER, including
any claims for allegedly defective material, shortage, negligence, or any other
cause whatsoever ("defective performance") shall be deemed waived unless made in
writing and received by the other party within the applicable time period set
forth in Article 9B above. Failure by BUYER to give notice of any claim for any
defective performance within the applicable time period hereunder shall be an
unconditional waiver of such claim. Except for personal injury or property
damage as set forth below, BUYER's exclusive remedy for any defective
performance hereunder for any and all losses and damages resulting from any
cause whatsoever including, without limitation, alleged breach of warranty or
negligence, shall not exceed the purchase price of the PRODUCTS in respect of
which such claim is made, or on mutual agreement of BUYER and SELLER, in
appropriate circumstances, replacement of such PRODUCTS. SELLER shall not be
liable for personal injury or property damage resulting from the handling,
possession, use, or resale of the PRODUCTS by BUYER, whether alone or in
connection with any other product, except to the extent it is shown that such
personal injury or property damage was caused by the failure of the PRODUCT to
meet the manufacturing standards and warranties which are those and only those
explicitly set forth in this Agreement at the time of delivery to BUYER. In no
event shall either party be liable for incidental or consequential damages of
any nature.
16. INDEMNIFICATION
Subject to Article 15 of this Agreement:
A. SELLER will defend, indemnify and hold harmless BUYER, its officers,
agents, parent
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companies, partners 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 relating to
PRODUCTS, which results solely from the negligence or willful
misconduct of SELLER.
B. BUYER will defend, indemnify and hold harmless SELLER, its officers,
agents, partners 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 relating to
PRODUCTS, which results solely from the negligence or willful
misconduct of BUYER.
C. In the event that negligence or willful misconduct of both SELLER and
BUYER contribute to any such loss, damage, claim, injury, cost or
expense, SELLER and BUYER will each defend, indemnify and hold harmless
the other with respect to that portion of the loss, damage, claim,
injury, cost or expense attributable to its negligence or willful
misconduct.
17. TERMINATION
A. Either party may terminate this Agreement at any time by delivering
written notice of termination if the other party breaches a material
term of the Agreement and fails to substantially remedy the breach
within *** days after receiving written notice of the breach, or in the
case of a breach involving non-payment of any sums due hereunder fails
completely to remedy such breach within *** days after receiving
written notice thereof. The effective date of termination shall be
specified in such termination notice. Termination may be immediate if
it is clear that the breach cannot reasonably be cured.
B. Either party may terminate this Agreement immediately in its entirety
if the other party files a petition of bankruptcy, is adjudged
bankrupt, takes advantage of any insolvency act, or executes a xxxx of
sale, deed of trust, or assignment for the benefit of creditors.
C. The rights and obligations contained in articles of this Agreement
covering warranties, indemnification and confidentiality will survive
termination of this Agreement, as will any rights to payment or other
rights or obligations that have accrued under this Agreement prior to
termination. Termination will not affect a party's liability by reason
of any act, default, or occurrence prior to termination.
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18. APPLICABLE LAW
This Agreement shall be construed, and the respective rights of BUYER and
SELLER shall be determined, in accordance with the laws of the state of
Delaware.
19. NOTICE
Except as set forth in Article 13.B., any notices hereunder shall be
delivered in writing addressed as follows:
If to BUYER:
Xx. Xxxxx X. Xxxxx, President and CEO
Endo Pharmaceuticals, Inc.
000 Xxxxxxxxxx Xxxx Xxxxxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxxxxxx 00000
with copy to:
Xxxxxx X. Xxxxxxxx, Senior Vice President Business Development
Endo Pharmaceuticals, Inc.
000 Xxxxxxxxxx Xxxx Xxxxxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxxxxxx 00000
If to SELLER:
Xxxxxxx X. Xxxxxxx
President, Pharmaceuticals Group
Mallinckrodt Inc.
000 XxXxxxxxx Xxxxxxxxx
X.X. Xxx 0000
Xx. Xxxxx, Xxxxxxxx 00000
with copy to:
C. Xxxxxxx Xxxxxx
Staff Vice President, Legal
Mallinckrodt Inc.
000 XxXxxxxxx Xxxxxxxxx
X.X. Xxx 0000
Xx. Xxxxx, Xxxxxxxx 00000
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20. PARTIES BOUND
This Agreement shall be binding upon and inure to the benefit of the
parties hereto and their successors and assigns; provided, however that neither
party shall assign any of its rights or obligations hereunder without the prior
written consent of the other party, except as an incident to the merger,
consolidation, reorganization, or acquisition of actual voting control or
substantially all of the assets of the assigning party.
21. ALLOCATION/ALTERNATE MANUFACTURE
If at any xxxx XXXXXX is unable for any reason, including without
limitation Force Majeure, to supply BUYER with its requirements of PRODUCTS in
such quantities as SELLER is obligated to supply under this Agreement, then
SELLER shall promptly notify BUYER. In such event, SELLER shall allocate between
BUYER, SELLER's other customers and SELLER (including Affiliates of SELLER) its
entire supply of PRODUCTS in a fair and equitable manner. In the event of a
PRODUCT shortage, SELLER and BUYER together shall use their best efforts to
develop and implement a mutually acceptable plan to help BUYER either
manufacture or obtain PRODUCTS from third parties during the period of
allocation.
22. ENTIRE AGREEMENT
This Agreement constitutes the entire agreement between the parties hereto
concerning this subject matter and supersedes all previous and/or
contemporaneous agreements, whether written or oral. This Agreement may not be
modified orally, and no modifications or any claimed waiver of any of the
provisions hereof shall be binding unless in writing and signed by the party
against whom enforcement of such modification or waiver is sought. Any printed
provisions on any forms used by either party in connection with shipments
hereunder (e.g., purchase orders, acknowledgments, invoices) shall be of no
effect whatsoever despite any provision on the form to the contrary, unless such
provisions specifically refer to, and purport to modify, this Agreement and such
------------
writing is signed by both parties hereto. In the event of a conflict between
the terms set forth in the body of this Agreement and those set forth in any
Attachment hereto, the terms set forth in the body of this Agreement shall
control.
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23. WAIVER
The waiver by either party hereto of a breach of any provision of this
Agreement shall not operate or be construed as a waiver of any other breach,
whether or not related to the same provision and whether prior or subsequent to
such waived breach.
24. EXCLUSIVE REMEDY
Each of the remedies set forth herein constitute the exclusive remedy of
the appropriate party with respect to the breach or occurrence to which the
remedy relates in accordance with the terms hereof.
25. OTHER ACTIVITIES
Each party to this Agreement understands that the other party may be
interested, directly or indirectly, in various activities or undertakings which
may be competitive with the business activities of the first-mentioned party.
Each party agrees that its determination to enter into this Agreement shall be
without prejudice to the rights of the other party to pursue such interests or
engage in any such activities or undertakings.
26. COUNTERPARTS
This Agreement may be executed in one or more identical counterparts, each
of which shall be deemed an original but all of which together shall constitute
one and the same instrument.
27. NO CURRENT BREACHES OR CLAIMS
This Agreement is effective with respect to firm orders received on and
after July 1, 2003. Each of BUYER and SELLER represents that, to its knowledge,
the other party hereto is, as of the date this Agreement is executed, in full
compliance with the terms and conditions of this Agreement.
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IN WITNESS WHEREOF, SELLER and BUYER have executed this as of the dates
indicated below.
MALLINCKRODT INC.
By: /s/ Xxxxxxx X. Xxxxxxx
__________________________________________
Name: Xxxxxxx X. Xxxxxxx
Title: President, Pharmaceuticals Group
ENDO PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxx
__________________________________________
Name: Xxxxx X. Xxxxx
Title: President and CEO
17
ATTACHMENT "A"
PRODUCT LISTING AND PRICING SCHEDULE
***
18
ATTACHMENT B
SPECIFICATIONS
***
19
ATTACHMENT "C"
CONFIDENTIALITY AGREEMENT
This Agreement is made this 14th day of July, 1998 between Endo Pharmaceuticals
Inc. located at 000 Xxxxxxxxxx Xxxx Xxxxxxx Xxxx, Xxxxxx Xxxx, Xxxxxxxxxxxx
00000 and Mallinckrodt Inc. located at 000 XxXxxxxxx Xxxxxxxxx, Xx. Xxxxx,
Xxxxxxxx 00000.
WHEREAS, the parties hereto, wish to discuss a mutually beneficial relationship,
and in so doing, may disclose to each other in oral and written form or in other
medium, certain confidential and proprietary information relating to their
respective technologies, services, products and product development plans and
ideas.
NOW THEREFORE, the parties hereto, intending to be legally bound, agree as
follows:
1. For purposes of this Agreement, "Confidential Information" shall mean all
non-public and proprietary information which has been or will be disclosed
by one party to the other that is set forth orally or in writing, or
contained in some other tangible form.
2. The parties hereby agree to hold in strictest confidence any and all
Confidential Information disclosed by one party to the other under the terms
of this Agreement. The parties hereby agree that the following shall not be
considered Confidential Information subject to this Agreement:
(a) information which at the time of disclosure, is in the public domain;
(b) information which, after disclosure becomes part of the public domain
by publicating or otherwise, provided that such publication is not in
violation of this Agreement or any other confidentiality agreement;
(c) information that the receiving party can establish in writing was
already known to it or was in its possession at the time of disclosure
and was not acquired, directly or indirectly, from the disclosing
party;
(d) information that the receiving party lawfully received from a third
party, provided however, that such third party was not obligated to
hold such information in confidence;
(e) information that the receiving party is compelled to disclose by a
court or other tribunal of competent jurisdiction, provided however,
that in such case the receiving party shall immediately give notice to
the providing party so that the providing party may seek a protective
order or other remedy from said court or tribunal. In any event, the
receiving party shall disclose only that portion of the Confidential
Information that, in the opinion of its 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;
(f) information that was developed by employees of the receiving party who
did not have access to the other party's Confidential Information.
3. The receiving party shall not use nor disclose to any third party
Confidential Information for any purpose other than for the purposes set
forth in this Agreement.
4. The receiving party will not disclose any such Confidential Information to
any person other than to its employees and officers that have a need to know
such information to effectuate the purpose of this Agreement and that such
employees and officers shall be informed of this Confidentiality Agreement
and shall in writing, be bound by its terms.
5. Upon written request of the disclosing party, the receiving party shall
return promptly to the disclosing party all Confidential Information
furnished to it, including any copies thereof and notes or extracts based
thereon; and until this Agreement is terminated or becomes inoperative,
20
Confidentiality Agreement
shall keep confidential and not use in any way detrimental to the
disclosing party any analyses, compilations, studies or other documents
which reflect any of the Confidential Information.
6. Each party agrees that for a period of three (3) years from the date of
this Agreement that it will not use information gained in the course of
the above evaluation (including the identity of specific employees) to
solicit the employment of any employee of the other party. This
paragraph shall not prohibit the solicitation of employees in the
ordinary course of business through general advertisements or placement
agencies that are not directed to specific individuals or companies.
Still further, this paragraph shall have no effect on hiring conducted
by employees who are not aware of the terms of this Agreement. Provided
however, that the parties hereto will notify all appropriate members of
its respective staff, involved with the performance of this Agreement,
of the terms of this Paragraph 6.
7. Title to, and all rights emanating from the ownership of, all
Confidential Information disclosed under this Agreement shall remain
vested in the disclosing party. Nothing herein shall be construed as
granting any license or option, in favor of the receiving party, in such
Confidential Information under any parent, copyright and/or any other
rights now or hereafter held by the disclosing party in or as a result
of such Confidential Information other than as specifically agreed upon
by the parties.
8. confidential Information shall remain subject to this Agreement for a
period of five (5) years from the date first above written, unless
sooner terminated by written mutual agreement of the parties.
9. The execution and performance of this Agreement does not obligate the
parties to enter into any other agreement or to perform any obligations
other than as specified herein.
10. The receiving party agrees that the disclosure of Confidential
Information to any third party without the express written consent of
the disclosing party will cause irreparable harm to the disclosing
party, and that any breach or threatened breach of this Agreement by the
receiving party will entitle the disclosing party to injunctive relief,
in addition to any other legal remedies available to it, in any court of
competent jurisdiction.
11. The parties hereby agree that this Agreement represents the entire
agreement between the parties with respect to the subject matter hereof
and supersedes all prior and/or counterporaneous agreements and
understandings between the parties with relation to this subject matter,
whether written, oral, visual, audio or in any other medium whatsoever.
This Agreement shall be governed by the laws of the Commonwealth of
Pennsylvania without reference to its conflict of laws rules.
ENDO PHARMACEUTICALS INC. MALLINCKRODT INC.
By: /s/ Xxxxxx X. Xxxxxxxx By: /s/ Xxxxxxx X. Milesovich
------------------------------ ------------------------------
Xxxxxx X. Xxxxxxxx Name: Xxxxxxx X. Milesovich
Senior Vice President Title: Vice President
Business Development
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