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EXHIBIT 10.20
MANUFACTURE AND SUPPLY
AGREEMENT
BETWEEN XXXXXXX LABORATORIES INC.
MERIDIAN CENTER II, 0 XXXXXXXXXX XXX XXXX
XXXXXXXXX, XXX XXXXXX, 00000
AND KING PHARMACEUTICALS, INC.
000 XXXXX XXXXXX
XXXXXXX, XX 00000
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MANUFACTURE AND SUPPLY AGREEMENT
KPI AND XXXXXXX LABORATORIES, INC.
TABLE OF CONTENTS
1.0 - GENERAL DEFINITIONS......................................................................................2
2.0 - SCOPE OF WORK............................................................................................3
3.0 - DEVELOPMENTAL WORK AND STABILITY TESTING.................................................................4
4.0 - FINANCIAL PROVISIONS.....................................................................................4
5.0 - TERM AND TERMINATION.....................................................................................5
6.0 - REQUIRED DOCUMENTS.......................................................................................7
7.0 - MANUFACTURE AND SUPPLY ARRANGEMENTS......................................................................8
8.0 - TITLE AND RISK OF LOSS..................................................................................10
9.0 - ANALYTICAL CERTIFICATION AND REGULATORY COMPLIANCE......................................................10
10.0 - REJECTED SHIPMENTS......................................................................................10
11.0 - PRODUCT COMPLAINTS/ADVERSE REACTION REPORTS.............................................................12
12.0 - PRODUCT RECALLS.........................................................................................13
13.0 - COMPLIANCE WITH LAWS....................................................................................14
14.0 - KPI WARRANTY............................................................................................14
15.0 - lNDEMNIFICATION.........................................................................................15
16.0 - XXXXXXX' WARRANTIES.....................................................................................16
17.0 - DEFAULT.................................................................................................16
18.0 - DISPOSITION OF PROPERTY UPON TERMINATION................................................................17
19.0 - INDEPENDENT CONTRACTOR..................................................................................17
20.0 - FORCE MAJEURE...........................................................................................18
21.0 - CONFIDENTIALITY.........................................................................................18
22.0 - GENERAL PROVISIONS......................................................................................20
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MANUFACTURE AND SUPPLY AGREEMENT
THIS AGREEMENT, is made this 5th day of October, 1995 (the "Effective
Date") by and between XXXXXXX LABORATORIES INC., a New Jersey corporation with
offices at Meridian Center II, 0 Xxxxxxxxxx Xxx Xxxx, Xxxxxxxxx, Xxx Xxxxxx,
00000 ("XXXXXXX") and KING PHARMACEUTICALS, INC., a Tennessee corporation with
offices at 000 Xxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxx 00000 ("KPI"); individually KPI
or XXXXXXX may be referred to as a "Party" and collectively as the "Parties."
WITNESSETH:
WHEREAS, XXXXXXX desires KPI to undertake the manufacture of Nucofed(R)
in syrup and capsule presentations and Tigan(R) in capsule, suppository,
ampoule, vial, and syringe presentations and to purchase same from KPI and KPI
desires to manufacture and sell same to XXXXXXX;
NOW, THEREFORE, in consideration of the covenants and conditions set
forth herein, the Parties agree as follows:
1.0 - GENERAL DEFINITIONS
1.1 "AGREEMENT" shall mean this document and all attachments, exhibits,
schedules, and addenda.
1.2 "PRODUCT" OR "PRODUCTS" shall mean those products in the strengths and
presentations listed in Exhibit A, attached hereto and incorporated herein by
reference.
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1.3 "ACT" means the United States Food, Drug, and Cosmetic Act, as amended.
1.4 "FDA" shall mean the U. S. Food and Drug Administration.
1.5 "SPECIFICATIONS" shall mean the confidential specifications for the
manufacture of Products set forth in Schedule B, attached hereto and
incorporated herein by reference, and which may be modified in writing by mutual
agreement of the Parties from time to time and with any necessary FDA approval
as appropriate.
1.6 "TRANSFER PRICE" shall mean the price charged to XXXXXXX by KPI for the
Products, said price being described in Schedule C attached hereto and made a
part hereof, subject; however, to price adjustments as provided for in this
Agreement and in Schedule C itself.
1.7 "PRODUCTION YEAR" shall mean each period of one calendar year from January
1st through December 31st during the term of this Agreement, provided that the
initial "Production Year" for this Agreement shall commence on the Effective
Date of this Agreement and shall terminate on December 31, 1995.
2.0 - SCOPE OF WORK
Subject to the terms and conditions of this Agreement, XXXXXXX agrees to
purchase all of its requirements for the Products from KPI and KPI agrees to
manufacture and supply to XXXXXXX' Product, conforming to the Specifications, in
the quantities ordered by XXXXXXX, subject to the provisions of Section 7 of
this Agreement and all other provisions and conditions of this Agreement. KPI
shall be responsible for conducting a stability program concerning the Products,
said program to be carried out in the manner outlined in Exhibit D, attached
hereto and made a part hereof, and at the cost set forth in Section 3.0 herein.
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3.0 - DEVELOPMENTAL WORK AND STABILITY TESTING
This Agreement contemplates no development work. Any arrangement for
development work will be negotiated by the Parties and memorialized in a
separate agreement. KPI shall make use of its facilities in conducting the
stability program set out in Exhibit X. XXXXXXX shall pay KPI for such stability
work at KPI's then prevailing rates, as such rates are from time to time
established by KPI, but which shall not be less than $60.00 per hour (or any
part thereof) per laboratory technician or support person.
4.0 - FINANCIAL PROVISIONS
4.1 TRANSFER PRICE. Subject to the provisions of Subsection 4.2, KPI shall
manufacture and sell Product to XXXXXXX at the scheduled Transfer Price, further
subject to any price adjustments described in Subsection 4.3. Said Transfer
Price is conditioned upon, and assumes delivery, F.O.B. KING Pharmaceuticals,
Inc., Bristol, Tennessee.
4.2 PAYMENT. The balance of any invoice shall be due KPI within thirty (30) days
of the date of the invoice, said invoice to be issued by KPI upon shipment of
the Product to XXXXXXX. Late payment of undisputed invoiced amounts will incur
interest charges at the rate of one and one-half percent (1.5%) per month
beginning on the first day of the month in which the original payment was due
for the period from the due date until the date payment is made.
4.3 INCREASES TO TRANSFER PRICES. The term Transfer Price shall be subject to
increase according to the following mechanisms at KPI's sole discretion:
4.3.1 RAW MATERIAL/REGULATORY COST INCREASES. KPI shall have the
unconditional right to increase the Transfer Prices for Products up to five
percent (5%) per Production Year without documentation of cost increases to
XXXXXXX. If KPI's documented year-over-year raw
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materials' costs increase more than five percent (5%), then KPI shall also have
the additional right to increase the Transfer Price by a corresponding amount
provided; however, KPI shall provide written proof of same to XXXXXXX. If new or
additional U.S. Governmental regulations or state regulations increase KPI's
regulatory costs, then the Parties agree to negotiate in good faith additional
price increases.
4.3.2 COST OF LIVING INCREASES. In addition to the adjustments to the
Transfer Prices outlined in Subsection 4.3.1, KPI shall have the unconditional
right to increase the Transfer Prices for Products by percentages equal to
increases in the Cost of Living as evidenced by the Consumer Price Index as
published quarterly by the United States Government.
5.0 - TERM AND TERMINATION
5.1 TERM. This Agreement shall commence on the Effective Date (but shall also
apply to XXXXXXX' purchase order #2666 dated October 5, 1995) and shall
continue until 11:59 p.m. on December 31, 2000 or unless sooner terminated or
extended as hereinafter provided. Notwithstanding the foregoing, this Agreement
shall be automatically renewed for additional two (2) year periods unless either
party shall notify the other of its intention not to renew the Agreement at
least two (2) years prior to the expiration of the initial term of this
Agreement or of any renewal or renewals thereof.
5.2 TERMINATION. Prior to the expiration of the initial or any renewal term,
this Agreement may be terminated as below provided upon the occurrence of any of
the following events:
5.2.1 MATERIAL BREACH. Such termination shall be effective sixty (60)
days written notice is delivered by either Party to the other Party in the event
that the other Party
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breaches any material provision of this Agreement, and such other Party fails to
remedy such material breach prior to expiration of the sixty (60) day notice
period.
5.2.2 INSOLVENCY. Such termination shall be immediately effective upon
written notice delivered by either Party to the other upon the insolvency,
bankruptcy or any other reorganization of the other Party under the Bankruptcy
Code.
5.2.3 REPEATEDLY LATE PAYMENTS. Such termination shall be effective
sixty (60) days after written notice of a history or continuing series of late
uncontested payments or failure to pay interest due on late payments. In this
context, any three instances of late payments, late interest payments, or any
combination of the two in any Production Year shall be considered a "history or
continuing series."
5.2.4 FAILURE TO PROVIDE PROJECTIONS. Such termination at KPI's option
shall be immediately effective upon two or more failures of XXXXXXX during any
Production Year or renewal term hereof to supply projections or forecasts within
the established time.
5.2.5 FDA ACTION. Such termination shall be immediately effective in
the event of action by the FDA or any federal, state or local regulatory agency,
board, or group removing or recalling Product or materially interrupting with
the continuous manufacturing, packaging, or shipping of the Product, through no
fault of KPI.
5.2.6 NO PURCHASES. As to any of the Products listed in Schedule A, if
XXXXXXX should fail to order a minimum of one (1) batch per Production Year with
the exception of the first Production Year, then the Agreement shall become void
only as to those Products not ordered.
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5.2.7 MUTUAL CONSENT. Such termination shall be immediately effective
upon the written consent of the Parties; or
5.2.8 OTHERWISE PROVIDED. As may be otherwise provided or permitted
under this Agreement.
5.3 SURVIVAL PROVISIONS. Termination under Subsection 5.2 shall not relieve
either Party of any obligations or liabilities incurred by such Party prior to
or in connection with termination. The provisions of Sections 11.0, 12.0, 13.0,
15.0, 16.0 and 21.0 shall survive the termination or cancellation of this
Agreement for any reason.
6.0 - REQUIRED DOCUMENTS
6.1 REGULATORY FILINGS. It will be the primary obligation of XXXXXXX to prepare
and file any and all documents required by regulatory agencies to allow KPI to
lawfully produce the Product and XXXXXXX to lawfully use or sell the Product;
however King agrees to cooperate in such preparation and filing and to supply
whatever information and documentation may be necessary or advisable in
connection with any such regulatory filings. Any requests by XXXXXXX for or that
results in duplication or copies of work previously submitted to XXXXXXX by KPI
will be charged to XXXXXXX at the then prevailing rate for stability work.
Notwithstanding the foregoing, regulatory approval and administration of the
Product shall be the sole responsibility of XXXXXXX.
6.2 PRODUCTION AND CONTROL DOCUMENTS. XXXXXXX will provide KPI with copies of
all information necessary to manufacture, package and ship the Product
including, but not limited to, all information described in the Schedules,
analytical methods, other control procedures and
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relevant material safety data sheets to the extent that any such information is
not in KPI's possession.
6.3 APPLICABILITY OF THE CONFIDENTIALITY PROVISIONS. Any exchange of information
by the parties required by Subsections 6.1 and 6.2 above shall be governed by
and subject to the provisions of Section 21.0 of this Agreement.
7.0 - MANUFACTURE AND SUPPLY ARRANGEMENTS
7.1 FORECASTS AND REQUIREMENT ESTIMATES. Within thirty (30) days of the
Effective Date of this Agreement, XXXXXXX shall furnish KPI with an estimate of
its annual requirements of the Products from KPI, calculated on a month to month
basis. This annual forecast shall be updated only once per quarter year by
XXXXXXX and shall be updated on or before sixty (60) calendar days prior to the
start of each subsequent calendar quarter. Each current or first quarter of the
rolling annual forecast shall constitute a binding purchase order by XXXXXXX;
provided however, that KPI shall have the opportunity to comment upon all
forecasts and quarterly updates and, within ten (10) business days after receipt
of such Product forecast, shall advise XXXXXXX whether a forecast unreasonably
exceeds KPI's anticipated capacity or other concerns KPI may have about the
forecast. For any given calendar quarter, KPI shall be obligated to provide no
less that ninety percent (90%) and no more than one hundred ten percent (110%)
of the Product forecast for the quarter immediately preceding the then current
quarter. The obligations of the Parties otherwise are governed by the terms and
conditions of this Agreement and none of the general terms and conditions of any
XXXXXXX purchase order form or any KPI
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acknowledgment shall be controlling. XXXXXXX acknowledges the materiality of the
forecasts to this Agreement and their importance to KPI's production planning.
7.2 DELIVERY OF PRODUCT. KPI shall deliver the Products to the carrier approved
by XXXXXXX FOB KPI's facility in Bristol, Tennessee.
7.3 ARTWORK AND COPY. XXXXXXX shall be responsible for all artwork and copy
relating to the final packaging and labeling of the Product. XXXXXXX shall also
be responsible for compliance with all federal, state and local laws and
regulations concerning the content of packaging and labeling, and for obtaining
any necessary regulatory approvals of printed materials, artwork and copy.
7.4 INSPECTIONS. Upon ten (10) calendar days' written notice, XXXXXXX shall have
the right to inspect, no more than once a calendar year, during normal business
hours, all records and facilities associated with the manufacture, processing
and packaging of Product, as well as with the receipt, storage and issuance of
components and ingredients thereof.
7.5 REPORTS AND RECORDS. KPI agrees to maintain and to preserve throughout the
term of this Agreement, and for a period of three (3) years following
termination of this Agreement, or for such longer period as may be required by
applicable law or regulation, all books, records and other documents relating to
KPI's performance of manufacturing services pursuant to this Agreement. During
such period(s), XXXXXXX shall have the right, upon ten (10) days' written notice
and within normal business hours, to examine and copy, any such records.
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8.0 - TITLE AND RISK OF LOSS
Title to and risk of loss of and Products shall remain with XXXXXXX.
KPI shall not sell, pledge, hypothecate, dispose of, or otherwise transfer any
interest in the Products except as otherwise provided in this Agreement. KPI
shall provide safe and secure storage conditions for the Products while they are
at KPI's location.
9.0 - ANALYTICAL CERTIFICATION AND REGULATORY COMPLIANCE
9.1 CERTIFICATE OF ANALYSIS. Before delivery to XXXXXXX, each lot of Product
shall be tested by KPI in accordance with the Specifications. The items tested,
general specifications and test results shall be set forth in a Certificate of
Analysis for each lot delivered. These certificates shall confirm that the
Product lot test results met the acceptance criteria established for the
Products.
9.2 REGULATORY COMPLIANCE. KPI shall advise XXXXXXX immediately if an authorized
agent of any governmental agency visits KPI's manufacturing facility and
requires changes to be made in the method of manufacture or packaging of the
Product. In such event, KPI shall not implement any such change without
obtaining prior written approval from XXXXXXX, which approval shall not be
unreasonably withheld, always subject to any necessary regulatory approvals.
Copies of documents left by authorized agents of governmental agencies (Form
FDA 483) that directly relate to the Product shall be furnished to XXXXXXX in a
timely manner.
10.0 - REJECTED SHIPMENTS
10.1 PRODUCT FAILS TO MEET SPECIFICATIONS. Within fifteen (15) days after its
receipt of each shipment of Product and the related Certificate of Analysis,
XXXXXXX shall notify KPI in writing if XXXXXXX chooses to reject the shipment,
otherwise the shipment shall be deemed
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accepted by XXXXXXX. Any notification of rejection shall state with specificity
the basis for rejection, and shall state whether XXXXXXX requests the rejected
shipment to be replaced with a new shipment of Product. A replacement shipment
of Product so requested by XXXXXXX shall be made by KPI as soon as practicable
using reasonable efforts (but no later than sixty (60) days after KPI receives
such notification), or as soon thereafter as the necessary materials and
components are made available to KPI for the manufacture of replacement Product.
Such replacement Product shall be invoiced by KPI and paid for by XXXXXXX at the
same price as invoiced for the rejected shipment of Product.
10.2 NO OBLIGATION TO PAY. XXXXXXX shall not be obligated to pay for any
rejected shipment of Product which fails to meet Specifications for the
Products, but XXXXXXX shall be obligated to pay in full for any rejected
shipment of Product which does meet said Specifications. In the event XXXXXXX
states in its Notice of Rejection that such rejection is based on the Product
failing to meet the appropriate specifications, KPI shall have twenty (20) days
within which to notify XXXXXXX in writing of KPI's objection thereto, and the
parties shall, within ten (10) days after KPI sends its objection to XXXXXXX,
submit the issue to an independent laboratory in accordance with Subsection 10.3
below.
10.3 CONFLICTING TEST RESULTS. In the event of a conflict between the test
results of KPI and the test results of XXXXXXX with respect to any shipment of
Product by KPI, an effort will be made to reconcile the test results. If the
parties fail to reconcile such results within (10) days after KPI sends it
notice of objection pursuant to Section 10.2, an adequate sample of the rejected
Product shall be submitted by KPI to an independent laboratory acceptable to
both Parties for
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testing against the Specifications for the Products using the procedures
described in those Specifications. The test results obtained by such laboratory
shall be final and controlling, and the fees and expenses of the laboratory
shall be borne entirely by the Party against whom such laboratory findings are
made. If the laboratory's findings are in favor of KPI, XXXXXXX shall
immediately pay KPI the price invoiced for the rejected Product together with
any interest or late payment charges that would have otherwise accrued.
10.4 RETURN OF REJECTED SHIPMENTS. KPI shall make arrangements with XXXXXXX for
the disposal of any shipment of Product rightfully and timely rejected by
XXXXXXX pursuant to this Section 10. The disposal costs for any rejected
shipment of Product shall be paid by KPI unless the independent laboratory
determination pursuant to Section 10.3 demonstrates that such rejected shipment
of Product conforms to the appropriate Specifications, in which case any such
disposal costs shall be for the account of XXXXXXX.
11.0 - PRODUCT COMPLAINTS/ADVERSE REACTION REPORTS
11.1 KPI TO NOTIFY XXXXXXX. KPI shall notify XXXXXXX in writing within two (2)
working days of obtaining any information or knowledge concerning any visit or
inspection of KPI by the FDA regarding Products or KPI's manufacturing processes
related to the Products and any serious or unexpected side effect, injury,
toxicity, or sensitivity reaction, any unexpected incidents, or any adverse drug
experience reports and the severity thereof associated with Product whether or
not determined to be related to use of Products. Such notice to XXXXXXX shall be
sent by fax, to the attention of the Director of Xxxxxxx' Regulatory Affairs
department, or his designate, at the current fax number of (000) 000-0000. KPI
shall also notify XXXXXXX in
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writing in a timely manner of any other adverse experience whether or not
considered related to Products.
11.2 PRODUCT COMPLAINTS. Product complaint reports received by XXXXXXX will be
summarized and sent to KPI by fax, to the Medical Affairs Department, to the
attention of Xx. Xxxxx Xxxxxxxx at the current fax number (000) 000-0000 with an
original sent on the same day by U.S. Mail as provided in section 22.1. Product
complaint reports which may meet FDA Field-alert Report criteria codified at 21
CFR 314.82 (B) (1) will be communicated to XXXXXXX in a timely fashion. XXXXXXX
will investigate all Product complaints associated with distribution or handling
and provide a written summary to KPI and a written response to the complainant,
with a copy to KPI as provided in Section 22.1. KPI will investigate all
Products complaints associated only with active or inactive ingredients,
container/closure systems, or general product quality.
12.0 - PRODUCT RECALLS
In the event a governmental entity issues a request, directive or order
that the Product be recalled, or a court of competent jurisdiction orders such a
recall, or XXXXXXX voluntarily elects to recall the Product, the Parties shall
take all appropriate recall actions. If such recall results from the breach of
KPI's warranties under this Agreement, defective manufacture or packaging, or
other breach or fault of KPI, KPI shall be responsible for the expenses of the
recall. However, in the event the recall occurs for any other reason, including
without limitation, misrepresentation, misbranding, or XXXXXXX negligence or
willful action, or other breach or fault of XXXXXXX, XXXXXXX shall be
responsible for all expenses of recall. For the purposes
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of this Agreement, the "expenses of recall" shall mean the expenses associated
with customer notification, product return, replacement or destruction, and any
other charges incurred in order to comply with recall procedures.
13.0 COMPLIANCE WITH LAWS
13.1 PERMITS. KPI represents that it holds and, during this Agreement, will
maintain all required licenses, permits and similar governmental authorizations
(collectively, the "Permits") required for its performance under this Agreement.
13.2 ADDITIONAL AGREEMENTS. KPI agrees to, and shall comply with, the following:
(a) Comply with all federal, state and local laws and regulations
applicable to its performance under this Agreement, including, the delivery of
Products to XXXXXXX; and
(b) Cooperate in the preparation of documents required by regulatory
agencies to permit performance under this Agreement. Notwithstanding the
foregoing, regulatory approval of any Products shall be the sole responsibility
of XXXXXXX provided; however, any work done by KPI, but not required by such
regulatory agencies to be done by KPI, to assist XXXXXXX in such matters (or to
assist XXXXXXX with the transfer of TIGAN(R) products to its ownership) shall be
billed to XXXXXXX by KPI at the rate then prevailing for stability work.
14.0 KPI WARRANTY
KPI warrants that the Product will be manufactured in conformity with
the Specifications for Products. KING MAKES NO OTHER WARRANTIES, EXPRESS OR
IMPLIED, WITH RESPECT TO PRODUCTS. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED.
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15.0 - INDEMNIFICATION
15.1 INDEMNIFICATION BY XXXXXXX. XXXXXXX shall indemnify, defend and hold KPI
harmless from and against any and all liabilities, damages, losses, costs or
expenses (including reasonable attorneys' fees), resulting from any third Party
claims made or suits brought against KPI which arise out of the handling,
storage, promotion, marketing, distribution, use or sale of the Products,
including without limitation, any claims (express, implied or statutory),
involving the efficacy, safety, or use to be made of the Products, or which
otherwise arise out of the negligence or willful misconduct of XXXXXXX or its
material breach of this Agreement, except to the extent such liability, damage,
loss, cost or expense (including reasonable attorneys' fees) results from the
breach of KPI's warranties under Section 13.0 hereof or KPI's negligence or
willful misconduct.
15.2 INDEMNIFICATION BY KPI. KPI shall indemnify, defend and hold XXXXXXX
harmless from and against any and all claims, liabilities, damages, losses,
costs or expenses (including reasonable attorney fees), resulting from any third
party claims or suits brought against XXXXXXX which arise out of KPI's
negligence or willful misconduct in its manufacture, packaging or handling of
the Product or its material breach of this Agreement, except to the extent such
liability, damage, loss, cost or expense (including reasonable attorneys fees)
results from the manufacture or packaging of Product in accordance with the
Specifications or by reason of XXXXXXX' negligence or willful misconduct.
Notwithstanding the foregoing, KPI shall not be liable for any lost profits to
XXXXXXX arising from XXXXXXX' failure to make sales of the Product due to the
failure of KPI to supply Product.
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15.3 CONDITIONS IMPOSED UPON INDEMNITY. If either Party proposes to seek
indemnification from the other under this subsection, it shall notify the other
Party in writing within thirty (30) days of receipt of the notice of any claim
or suit and shall cooperate fully with the other Party in the defense of all
such claims or suits. The indemnifying Party shall have control of any suit, and
no settlement or compromise shall be made or binding on the indemnifying Party
without its prior written consent.
16.0 - XXXXXXX' WARRANTIES
XXXXXXX warrants to KPI that the sales of the Products shall not
infringe any patent, trade secret or other proprietary rights and that
manufacture of the Product according to Specifications furnished by XXXXXXX to
KPI represents compliance with applicable regulatory-approved documents. XXXXXXX
shall indemnify, defend and hold KPI harmless from and against any and all
judgments, liabilities, damages, losses, costs or other expenses (including
reasonable attorney fees) arising from claims that any Product infringes patent
or other proprietary rights of a third party or that any Product manufactured
according to said Specifications are not in compliance with applicable
regulatory-approved documents.
17.0 - DEFAULT
If either Party hereto shall fail to perform or fulfill, at the time
and in the manner herein provided, any obligation or condition required to be
performed or fulfilled by such Party, and (a) if such Party fails to remedy any
such default (other than a default in a monetary payment) within sixty (60) days
of written notice theretofore given to it by the other Party, or (b) if such
failure consists of a default in a monetary payment which is not in dispute and
the defaulting Party fails
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to make such payment within thirty (30) days written of notice given to it by
the other Party, or (c) if either Party files a bankruptcy petition or initiates
a similar proceeding under state or federal law, or is insolvent, or (d) if
either Party, following the other Party's written request therefor, fails to
provide adequate written assurances of its intent and ability to discharge its
obligations timely and fully under this Agreement, such other Party thereafter
shall have the immediate right to terminate this Agreement upon written notice
of a default termination. Nothing contained in this Section 17 shall be
construed to exclude any other remedy for legal or equitable relief otherwise
provided, all rights and remedies being cumulative.
18.0 - DISPOSITION OF PROPERTY UPON TERMINATION
Upon termination of this Agreement, KPI, at the request of XXXXXXX,
shall permit any Product then held by KPI to remain at KPI's facility, without
cost or charge to XXXXXXX, for a period not exceeding thirty (30) days after
termination, in order for XXXXXXX to dispose or arrange for the disposition of
such property.
19.0 - INDEPENDENT CONTRACTOR
XXXXXXX neither assumes nor authorizes any representative or other
person to assume for it any obligation or liability other than such as is
expressly set forth herein. KPI shall be an independent contractor with respect
to the services to be performed hereunder. Neither KPI nor its employees shall
be deemed servants, joint ventures, partners, employees or agents of XXXXXXX.
Both KPI and XXXXXXX acknowledge that this Agreement does not constitute a
partnership, joint venture, cooperative effort, or any relationship between the
parties other than as independent contractors.
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20.0 - FORCE MAJEURE
Delay in or failure of performance by either Party hereto shall be
excused if and to the extent that such delay or failure is caused by an
occurrence beyond the reasonable control of the Party affected, including, but
not limited to, the availability of raw materials, acts of God, compliance with
orders of any governmental authority whether valid or invalid, acts of war,
rebellion, fires, floods, explosions, storms, riots, strikes or any similar
cause (i.e., "Force Majeure"). Upon the happening of an event constituting Force
Majeure, the Party affected thereby shall be excused from performance during its
continuance. Such Party shall promptly notify the other in writing of the
happening of the event and of the time during which it is anticipated such event
will affect the notifying Party's ability to perform its obligations under this
Agreement. The Party invoking the terms of this Section 20.0 shall use its
reasonable efforts to correct or ameliorate conditions giving rise to any delay
or failure of performance, but the settlement of any strike or labor dispute
will be entirely within the discretion of the affected Party.
21.0 - CONFIDENTIALITY
During the term of this Agreement it may be necessary for one Party to
disclose to the other certain confidential information including, but not
limited to, Product information, manufacturing information, testing methods,
forecasts, marketing plans, proposals, improvements, quality assurance
requirements, and the like (hereinafter "Confidential Information"). For a
period of two (2) years after the termination or expiration of this Agreement
with respect to the Products (including any extension hereof), the Party
receiving any such Confidential Information from the disclosing Party hereunder
shall exercise due care at all times
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22.0 - GENERAL PROVISIONS
22.1 NOTICES. Any notices permitted or required by this Agreement shall be
sent by telex or telecopy, or by certified or registered mail return receipt
requested and shall be effective when received if sent and addressed as follows,
or to such other address as may be designated by a Party in writing:
If to KPI: Xxxxxxxxx X. Xxxxxxx, Executive Vice President/General Manager
KPI Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxx 00000
with a copy to: Xxxx X. X. Xxxxxxx, Corporate Counsel
KPI Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxx 00000
If to XXXXXXX Attn: Xxxxxx Xxxxxxx
XXXXXXX LABORATORIES INC
Meridian Center II, 0 Xxxxxxxxxx Xxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx, 00000
with copy to: Xxxxxxx X. Xxxxxx
XXXXXXX LABORATORIES INC.
Meridian Center II, 0 Xxxxxxxxxx Xxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx, 00000
22.2 ENTIRE AGREEMENT. The Parties hereto acknowledge that this Agreement
sets forth the entire agreement and understanding of the Parties and supersedes
all prior written or oral agreements or understandings with respect to the
Products and the subject matter hereof, including specifically any rights or
obligations of the Parties arising out of or in any way connected to or stemming
from that certain manufacture and supply agreement, dated April 20, 1990,
between Xxxxxxx, Inc. and RSR Laboratories, Inc. (KPI being a successor in
interest to RSR Laboratories, Inc. under that agreement and Xxxxxxx being a
successor in interest, in part, to
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to prevent the unauthorized disclosure or use of Confidential Information
relating to said Product. This obligation shall not apply to:
(a) information which is known to the receiving Party prior to disclosure,
information known from or through prior agreements, or information independently
developed by the receiving Party, as evidenced by such Party's written records;
(b) information disclosed to the receiving Party hereunder in a
non-confidential manner by a third party who has a right to make a disclosure
and does not have an obligation of confidentiality to the disclosing Party
hereunder with respect to this disclosure;
(c) information which is or becomes (through no breach or fault of the
receiving Party) patented, published or otherwise part of the public domain; and
(d) information which is required to be disclosed under penalty of law;
provided, however, that the receiving Party has taken all steps available under
law (but not the institution of legal action) to protect this information and
notifies the disclosing Party hereunder of its obligation to make the disclosure
sufficiently prior to the time such disclosure is made to allow the disclosing
Party to seek a protective order.
All copies of Confidential Information disclosed in writing by one Party to
the other shall be returned to the disclosing Party within thirty (30) days of
the termination of this Agreement; however, the return of said copies does not
relieve the parties of their continuing obligation under this Agreement to
maintain the confidentiality of this information.
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the rights and obligations of Xxxxxxx, Inc. in the same agreement). No
modification of any of the terms of this Agreement, or any amendments thereto,
shall be deemed to be valid unless in writing and signed by the Party against
whom enforcement is sought. No course of dealing or usage of trade shall be used
to modify the terms and conditions herein.
22.3 WAIVER. No waiver by either Party of any default shall be effective
unless in writing, nor shall any such waiver operate as a waiver of any other
default or of the same default on a future occasion.
22.4 OBLIGATIONS TO THIRD PARTIES. Each Party warrants and represents that
the proceeding herein is not inconsistent with any contractual obligations,
expressed or implied, undertaken with any third party.
22.5 ASSIGNMENT. This Agreement shall be binding upon and inure to the
benefit of the successors or permitted assigns of each of the Parties and may
not be assigned by either Party without the prior written consent of the other,
which consent shall not be unreasonably withheld. An attempted assignment,
without such consent, shall be void.
22.6 GOVERNING LAW. The validity, interpretation and effect of this
Agreement shall be governed by and construed under the laws of the State of
Tennessee and any action brought by either Party shall be maintained exclusively
in courts sitting within the State of Tennessee.
22.7 SEVERABILITY. In the event that any provision of this Agreement shall
violate any applicable statute, regulation, ordinance or rule of law in any
jurisdiction in which it is used, or is otherwise unenforceable, that provision
shall be ineffective to the extent of the violation without invalidating any
other provision hereof.
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22.8 HEADINGS. The headings used in this Agreement are for convenience only
and are not a part of this Agreement.
22.9 COUNTERPARTS. This Agreement may be executed in counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same original.
22.10 SCHEDULES. The Exhibits attached hereto are made a part of this
Agreement as if fully set forth herein.
22.11 CONSTRUCTION OF VARIOUS WORDS AND PHRASES. The word "hereby",
"hereunder", and similar words refer to this entire Agreement and not merely to
the sections, subsections, or paragraphs wherein such words may appear.
"Including," "includes," and "include" and similar terms shall mean "including
without limitation," "includes without limitation," and "include without
limitation."
22.12 PLURALS, GENDERS, AND PERSONS. In this Agreement, words importing the
singular number only shall include the plural and vice versa; words importing a
specification of gender shall include the other gender; and, references to
persons shall include corporations, other business entities, and one or more
persons, their heirs, executors, administrators or assigns, as the case may be.
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IN WITNESS WHEREOF, the Parties hereto have each caused this Agreement
to be executed by their duly authorized representatives to be effective on the
Effective Date.
XXXXXXX LABORATORIES INC. KING PHARMACEUTICALS, INC.
By:/s/ Xxxxxxx X. Xxxxxx By:/s/ Xxxx X. Xxxxxxx
--------------------- -------------------------
Name: Xxxxxxx X. Xxxxxx Name: Xxxx X. Xxxxxxx
------------------- -----------------------
Title: Vice President Title: President
------------------ ----------------------
Date: Nov. 30, 1995 Date: Nov. 27, 1995
------------------- -----------------------
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ADDENDUM
TO
MANUFACTURE AND SUPPLY AGREEMENT
BETWEEN
XXXXXXX LABORATORIES, INC.
AND
KING PHARMACEUTICALS, INC.
WHEREAS, XXXXXXX LABORATORIES, INC. ("XXXXXXX") and KING
PHARMACEUTICALS, INC. ("KPI") entered into and executed a Manufacture and Supply
Agreement (the "Agreement") with an effective Date of (as the term "Effective
Date" is defined in the Agreement) of October 5, 1995, and
WHEREAS, the Agreement between XXXXXXX and KPI provides for the
manufacture of certain Products (as the term "Products" is defined in the
Agreement) by KPI for XXXXXXX at agreed upon Transfer Prices (as the term
"Transfer Price" is defined in the Agreement); and
WHEREAS, XXXXXXX and KPI now desire to add Tigan Suppositories 200 mg
in a sample presentation package of two and Tigan Pediatric Suppositories in a
sample presentation package of two to the definition of Products (as shown in
Exhibit A to the Agreement) with Transfer Prices of $0.85 for the Tigan 200 mg.
Suppository in a package of two (2) and $0.76 for the Tigan Pediatric
Suppository in a package of two (2);
NOW, THEREFORE, the Parties mutually agree:
1. The definition of Products in the Agreement and Exhibit A ("Products")
to the Agreement are amended to include the following:
PRODUCT NAME UNIT SIZE
------------ ---------
TIGAN Suppositories 200 mg 2 Suppositories/pkg.
TIGAN Pediatric Suppositories 2 Suppositories/pkg.
2. The definition of Transfer Prices in the Agreement and Exhibit C
("Transfer Prices") to the Agreement are amended to include the
following:
PRODUCT & UNIT SIZE PRICE\UNIT
------------------- ----------
TIGAN Suppositories 200 mg PKG of 2's $0.85
TIGAN Pediatric Suppositories PKG of 2's $0.76
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3. The Transfer Prices for the Tigan Suppositories 200 mg PKG of 2's and
the Tigan Pediatric Suppositories PKG of 2's are subject to price
revision of Section 4.3 of the Agreement as are all base Transfer
Prices.
4. All other terms, provisions, requirements, and conditions of the
Agreement not otherwise amended hereby remain in full force and effect.
IN WITNESS WHEREOF, the Parties hereto have each caused this Addendum
to be executed by their duly authorized representatives to be effective on the
date of signature by the last to sign of either XXXXXXX or KPI.
XXXXXXX LABORATORIES, INC. KING PHARMACEUTICALS, INC.
By:/s/ Xxxxxxx X. Xxxxxx By:/s/ Xxxx X. Xxxxxxx
--------------------- -------------------------
Name: Xxxxxxx X. Xxxxxx Name: Xxxx X. Xxxxxxx
------------------- -----------------------
Title: Vice President Title: President
------------------ ----------------------
Date: April 4, 1996 Date: March 29, 1996
------------------- -----------------------
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ASSIGNMENT AND ASSUMPTION OF CONTRACT AGREEMENT
This Assignment of Contract is made and entered into this 3rd day of
October, 1996, by and between Monarch Pharmaceuticals, Inc. ("Monarch"), a
Tennessee corporation, and King Pharmaceuticals, Inc. ("King"), a Tennessee
corporation, collectively Monarch and King are from time to time referred to as
"the Parties."
WHEREAS, Monarch has entered into a certain Asset Purchase Agreement
dated October 2, 1996 ("Asset Purchase Agreement") with Xxxxxxx Laboratories,
Inc. ("Xxxxxxx"), a New Jersey corporation, for the purchase of, among other
things, the Nucofed(R) product line, as the phrase "Nucofed(R) product line" is
defined in said Asset Purchase Agreement;
WHEREAS, pursuant to the Asset Purchase Agreement Xxxxxxx has assigned
and transferred to Monarch its rights and obligations with respect to the
manufacture of the Nucofed(R) products under a certain Manufacture and Supply
Agreement dated October 5, 1995 and as effectively amended on April 4, 1996 (the
"Manufacturing Agreement") entered into by Xxxxxxx and King;
WHEREAS, pursuant to the Asset Purchase Agreement Monarch has agreed to
assume all of the rights, interests and (except as set forth in the Asset
Purchase Agreement) obligations of Xxxxxxx related to the Nucofed(R) products
under the Manufacture and Supply Agreement; and
EXECUTION COPY
1
28
WHEREAS, King desires to consent to the assignment to Monarch of the
rights, interests, and obligations of Xxxxxxx under the Manufacture and Supply
Agreement as regards the Nucofed(R) products under the Manufacture and Supply
Agreement:
NOW THEREFORE, for valuable and good consideration, the receipt of
which is hereby acknowledged, Monarch, effective October 2, 1996, enters into
this Assignment and Assumption of Contract Agreement (the "Agreement") and
hereby assumes and agrees to pay, perform and discharge effective October 2,
1996 all of the obligations and liabilities of Xxxxxxx with respect to the
Nucofed(R) products under the Manufacture and Supply Agreement, to the extent
that they remain unperformed or unfulfilled on, or by their terms continue in
effect after, October 2, 1996.
By its execution of this Agreement, King hereby accepts: (i) Xxxxxxx'
assignment to Monarch of all of Xxxxxxx' rights with respect to the Nucofed(R)
products under the Manufacture and Supply Agreement and (ii) Monarch's
assumption of all of Xxxxxxx' obligations and liabilities with respect to the
Nucofed(R) products under the Manufacture and Supply Agreement a copy of which
is attached hereto and incorporated herein by reference as if fully set forth
verbatim herein.
Each of Monarch and King for itself, its successors and assigns, hereby
covenants and agrees that, at any time and from time to time upon the request of
the other, it will, at
EXECUTION COPY
2
29
its expense, do, execute, acknowledge and deliver or cause to be done, executed,
acknowledged and delivered, all such further acts, deeds or instruments, as may
be reasonably requested by the other, in order to effect the assignment of
rights and the assumption of obligations and liabilities pursuant hereto.
King hereby represents and warrants that Xxxxxxx is not in default of
any of its obligations under the Manufacture and Supply Agreement with respect
to the Nucofed(R) products under said Manufacture and Supply Agreement nor has
it waived by any action or inaction any of its rights under the Manufacture and
Supply Agreement. King further represents and warrants that King itself is not
in default of any of its obligations under the Manufacture and Supply Agreement
and that it will continue to honor its obligations thereunder with respect to
the Nucofed(R) products for the balance of the term of the Manufacture and
Supply Agreement or any sooner termination thereof.
It is specifically understood that Monarch is not hereby, and shall not
in any event be deemed to have assumed, undertaken or incurred any liability or
responsibility whatsoever for any obligation, liability or duty pursuant to the
Manufacture and Supply Agreement to the extent any such obligation, liability or
duty arises out of or relates to any performance (or failure to perform)
required or undertaken pursuant to the terms of the Manufacture and Supply
Agreement prior to October 2, 1996, or which otherwise relate to actions or
omissions of Xxxxxxx prior to October 2, 1996.
EXECUTION COPY
3
30
Anything herein or in the Asset Purchase Agreement to the contrary
notwithstanding, this Agreement and the Asset Purchase Agreement shall not
constitute an agreement to assign, transfer, or novate any contract, order,
commitment, license, or right if any such attempted assignment, transfer or
novation without the consent of the other party would constitute a breach
thereof or in any material way impair the rights of Xxxxxxx or Monarch (as
assignee) thereunder, unless and until such consent is obtained.
IN WITNESS WHEREOF, the parties have executed this Agreement this 3rd
day of October, 1996.
MONARCH PHARMACEUTICALS, INC.
By:/s/ Xxxxxx X. Xxxxxxx
-----------------------------------------
Its: President
----------------------------------------
KING PHARMACEUTICALS, INC.
By:/s/ Xxxxxxxxx X. Xxxxxxx
-----------------------------------------
Its: President
----------------------------------------
EXECUTION COPY
4
31
STATE OF TENNESSEE
COUNTY OF XXXXXXXX
The foregoing Assignment and Assumption of Contracts Agreement was
executed and acknowledged before me this 3rd day of October, 1996 by Xxxxxx X.
Xxxxxxx, personally known to me to be the President of Monarch Pharmaceuticals,
Inc., a Tennessee corporation, on behalf of said corporation.
----------------------------------------
Notary Public
My commission expires: January 24, 1999
EXECUTION COPY
5
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STATE OF TENNESSEE
COUNTY OF XXXXXXXX
The foregoing Assignment and Assumption of Contracts Agreement was executed
and acknowledged before me this 3rd day of October, 1996 by Xxxxxxxxx X.
Xxxxxxx, personally known to me to be the President of King Pharmaceuticals,
Inc., a Tennessee corporation, on behalf of said corporation.
----------------------------------------
Notary Public
My commission expires: January 24, 1999
EXECUTION COPY
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SECOND ADDENDUM TO
MANUFACTURE AND SUPPLY AGREEMENT
BETWEEN
XXXXXXX LABORATORIES, INC.
AND
KING PHARMACEUTICALS, INC.
WHEREAS, XXXXXXX LABORATORIES, INC. ("XXXXXXX") and KING
PHARMACEUTICALS, INC. ("KPI") entered into and executed a Manufacture and Supply
Agreement (the "Agreement") with an effective Date of (as the term "Effective
Date" is defined in the Agreement) of October 5, 1995, and
WHEREAS, the Agreement between XXXXXXX and KPI provides for the
manufacture of certain Products (as the term "Products" is defined in the
Agreement) by KPI for XXXXXXX, and
WHEREAS, the definition of Products in the Agreement included, among
other things, the Nucofed(R) products, and
WHEREAS, XXXXXXX and KPI subsequently amended the Agreement by
executing an Addendum effective August 4, 1996 (the "Addendum") to the
Agreement, and
WHEREAS, effective October 2, 1996, XXXXXXX sold to MONARCH
PHARMACEUTICALS, INC. ("MPI") the Nucofed(R) product line, as the term
"Nucofed(R) product line" is defined in the Asset Purchase agreement dated
October 2, 1996 entered into and executed by XXXXXXX and MPI, and
WHEREAS, KPI has consented to the assignment and assumption to and by
MPI of XXXXXXX' rights, obligations, and interests under the Agreement relative
to the Nucofed(R) product line and MPI has assumed such rights, obligations, and
interests, and
WHEREAS, XXXXXXX and KPI now desire to remove from the Agreement and
the Addendum, effective October 2, 1996, any obligation of XXXXXXX to purchase
from KPI any Nucofed(R) product under the Agreement or the Addendum;
NOW, THEREFORE, XXXXXXX and KPI (collectively, the "Parties") mutually
agree:
1. Effective October 2, 1996, the definition of "Products" under the
Agreement is amended to exclude all of the Nucofed(R) products.
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2. Any obligation, responsibility, liability, or charge of XXXXXXX
arising on or before October 2, 1996 with respect to the Products, including the
Nucofed(R) product line, shall remain the obligation, responsibility, liability
of charge of XXXXXXX under the terms and provisions of the Agreement or the
Addendum.
3. All other terms, provisions, requirements and conditions of the
Agreement an Addendum not otherwise amended hereby, including obligations of
Xxxxxxx, arising on or before October 2, 1996, remain in full force and effect.
IN WITNESS WHEREOF, the Parties hereto have each caused this Addendum
to be executed by their duly authorized representatives to be effective on the
date set forth above.
XXXXXXX LABORATORIES INC. KING PHARMACEUTICALS, INC.
By:/s/ Xxxxxxx X. Xxxxxx By:/s/ Xxxx Xxxxxxx
------------------------ -------------------------
Name: Xxxxxxx X. Xxxxxx Name: Xxxx Xxxxxxx
---------------------- -----------------------
Title: VP & General Counsel Title: VP & General Counsel
--------------------- ----------------------
Date: 1/16/97 Date: 01/07/97
---------------------- -----------------------
