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EXHIBIT 10.12
CONFIDENTIAL TREATMENT REQUEST
Confidential Portions Of This Agreement Which Have Been Redacted Are
Marked With Brackets ("[***]"). The Omitted Material Has Been Filed Separately
With The Securities And Exchange Commission.
MANUFACTURING AND SUPPLY AGREEMENT
THIS MANUFACTURING AND SUPPLY AGREEMEENT (the "Agreement") is made and
entered into this 23rd day of April, 1999 (the "Effective Date"), by and
between HORIZON PHARMACEUTICAL CORPORATION ("Horizon") and MIKART, INC.
("Mikart"). Mikart is a Georgia corporation with its principal place of
business at 0000 Xxxxxxxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxx 00000. Horizon is a
Delaware corporation with its principal place of business at 000 Xxxxxxx
Xxxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxx 00000.
BACKGROUND:
Subject to the terms and conditions contained in this Agreement,
Horizon desires to engage Mikart to manufacture the "Products" (as hereinafter
defined) for commercial distribution by Horizon, and Mikart desires to accept
such appointment.
NOW, THEREFORE, FOR AND IN CONSIDERATION of the premise, Ten Dollars
($10.00) in hand paid, the mutual promises, covenants and agreements contained
herein, and other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the parties hereto hereby agree as follows:
ARTICLE 1
DEFINITIONS
The following words, terms and phrases, when used herein, shall have
the following respective meanings:
1.1 "Batch" shall mean either: (a) the quantity of [***] tablets
of the Product to be marketed and sold as "Robinul;" or (b) the quantity of
[***] tablets of the Product to be marketed and sold as "Robinul Forte."
1.2 "Contract Year" shall mean a twelve (12) consecutive month
period after the Qualification Date and during the term of this Agreement. The
first Contract Year shall commence as of the Qualification Date, and subsequent
Contract Years shall commence on each anniversary of the Qualification Date.
1.3 "FDA" shall mean the United States Food and Drug
Administration or any successor agency thereof.
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1.4 "Health Registrations" shall mean the NDA issued by the FDA
with respect to the Products and any other governmental or regulatory consents,
registrations, approvals or permits necessary to sell or manufacture the
Products in the Territory.
1.5 "Products" shall mean Glycopyrrolate 1 mg U.S.P. tablets
(regardless of how packaged), which Product shall be marketed and sold by
Horizon as "Robinul," and Glycopyrrolate 2 mg U.S.P. tablets (regardless of how
packaged), which Product shall be marketed and sold by Horizon as "Robinul
Forte."
1.6 "Qualification Date" shall mean the date on which Mikart
satisfactorily completes its validation and testing pursuant to Article 2 of
this Agreement such that it becomes authorized to begin manufacturing the
Products under the Health Registrations in accordance with the terms of this
Agreement.
1.7 "Specifications" shall mean the specifications for the
manufacturing, packaging and labeling of the Products described on Exhibit A
attached hereto and incorporated herein by reference.
1.8 "Territory" shall mean the United States of America and its
territories and such other locations as may be designated by the parties hereto
pursuant to Section 2.6.
ARTICLE 2
VALIDATION AND TESTING
2.1 GENERAL. Mikart shall become authorized to manufacture and
package the Products under the Health Registrations as contemplated by Section
2.3. To accomplish the same, it is the current intention of Mikart and Horizon
to effect a transfer according to the SUPAC Guidelines; provided, however, if
such a transfer cannot be accomplished, Mikart shall (with Horizon paying
Mikart's reasonable out-of-pocket expenses therefor) develop an alternative
manufacturing process and prepare and file on behalf of Horizon with the FDA
and any other applicable agency or authority supplements to the Health
Registrations which, when and if approved, would permit Mikart to manufacture
the Products pursuant to this Agreement. In any event, Mikart will use all
reasonable efforts to become authorized to manufacture the Products as soon as
reasonably practicable after the Effective Date.
2.2 RIBBON BLENDER. Within sixty (60) days after the Effective
Date, Mikart will lease (for a period of five (5) years with monthly rental
payments in the amount of $405.00) and have installed a ribbon blender with a
minimum working capacity of thirty (30) cubic feet (the "Blender") for use in
manufacturing the Products. On or before the fifth (5th) day of such month
during the term of such lease, Horizon shall pay to Mikart an amount equal to
$405.00, and Horizon shall have the right, at its sole expense, to require
Mikart to purchase the Blender on Horizon's behalf.
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[***] - CONFIDENTIAL TREATMENT REQUESTED
2.3 VALIDATION. After its receipt of the Blender, Mikart shall
begin analytical methods development validation and process and cleaning
validation with respect to the Products. All of Mikart's costs incurred in
connection therewith (up to a maximum aggregate amount of [$***]) shall be
billed to and paid by Horizon on a quarterly basis (but based on a three (3)
year amortization schedule).
2.4 TESTING. Upon its successful completion of the validations
described in Section 2.3, Mikart will conduct stability testing on the Products
as required by federal law. All of Mikart's costs incurred in connection
therewith shall be periodically billed to and paid by Horizon on a quarterly
basis (but based on a three (3) year amortization schedule).
2.5 HEALTH REGISTRATIONS. Horizon shall maintain the Health
Registrations in full force and effect at all times during the term of this
Agreement; provided, however, upon the reasonable request of Horizon, Mikart
shall assist Horizon in connection therewith; provided further in exchange
therefor Horizon will pay Mikart its standard fees therefor. Mikart hereby
acknowledges and agrees that the Health Registrations are owned by, in the name
of and for the benefit of Horizon and that Mikart has no rights in or to any of
the Health Registrations, except to the extent it is expressly authorized to
manufacture the Products for Horizon pursuant to this Agreement.
2.6 ADDITIONAL LOCATIONS. In the event Horizon desires to market,
distribute or sell the Products in any location not set forth in Section 1.8
(or previously designated pursuant to this Section 2.6), then Mikart shall, at
Horizon's request, cooperate in good faith with Horizon to obtain any Health
Registrations necessary or appropriate therefor (and Horizon shall pay all of
Mikart's reasonable out-of-pocket expenses therefor); provided, however,
Horizon shall not market, distribute or sell any Products in such locations
unless and until Mikart obtains such Health Registrations.
ARTICLE 3
MANUFACTURE
3.1 EXCLUSIVITY. Subject to the terms and conditions contained
herein, Mikart shall manufacture, package and sell the Products exclusively to
Horizon from and after the Qualification Date and throughout the remainder of
the term of this Agreement (the "Manufacturing Period"), and Horizon shall
purchase exclusively from Mikart all of Horizon's requirements of the Products
during the Manufacturing Period. Except as otherwise permitted hereby, Mikart
agrees not to manufacture, package or sell to any other person or entity during
the term of this Agreement in any unit size or strength any other product which
contains the active ingredient Glycopyrrolate and either (a) contains no other
active ingredient, or (b) is approved for an indication for which the Products
are or become approved. Horizon hereby agrees that, in the event it desires to
sell, market or distribute any other product which contains the active
ingredient Glycopyrrolate during the term of this Agreement, it will negotiate
exclusively with Mikart regarding the manufacture thereof (which would be on
commercial terms other than price substantially similar to those contained
herein) for a period of at least ninety (90) days prior to negotiating therefor
with any other person or entity.
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3.2 LIMITED WARRANTIES. Mikart hereby represents and warrants to
Horizon that the Products manufactured and sold to Horizon hereunder shall
conform to the Specifications and shall be free of all defects in materials and
workmanship. The Products, when manufactured, packaged and sold to Horizon
shall comply with all applicable federal, state and local laws, rules and
regulations in the Territory, including without limitation the current Good
Manufacturing Practices as published and amended from time to time by the FDA,
and Mikart's manufacturing and storage facilities shall comply with all
applicable federal state and local laws, rules and regulations in the
Territory. EXCEPT AS SET FORTH IN THIS SECTION 3.2, MILKART MAKES NO OTHER
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE PRODUCTS
MANUFACTURED BY IT HEREUNDER AND SPECIFICALLY DISCLAIMS ALL SUCH OTHER
REPRESENTATIONS AND WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. With
respect to each batch of a Product manufactured hereunder, this Section 3.2
shall remain effective until the expiration date noted on such Product.
3.3 QUALITY CONTROL.
(a) Mikart will perform quality control testing on the
Products in accordance with normal industry standards to determine
whether such Products conform to the Specifications. Contemporaneously
with each shipment of Product hereunder, Mikart will provide Horizon
with a certificate of analysis with respect to such Product. In
addition, Mikart will perform, at Horizon's expense, any and all other
testing relating to the Products which is reasonably requested by
Horizon and promptly provide Horizon with the results thereof;
provided, however, Horizon shall not be responsible for the expenses
associated with any such testing which shows that such Product does
not meet the Specifications.
(b) In addition, Mikart shall be responsible for conducting
an ongoing stability program for the Products as required by federal
law. Mikart shall provide the results of such testing to Horizon in a
timely manner as this data is generated or received by Mikart.
Mikart's cost therefor shall be billed to and paid by Horizon on a
quarterly basis (but based on a three (3) year amortization schedule).
(c) Mikart will, upon the reasonable request of Horizon,
assay any Product returned to Horizon by a third party purchaser.
Horizon shall reimburse Mikart for the costs of any such assay unless
the results thereof prove the cause of return is as a result of
Mikart's negligence or willful misconduct or the failure of such
Product to comply with the limited warranties contained in Section 3.2
hereof.
(d) In the event that any Batch is subject to a recall,
Horizon, at its expense, shall conduct the recall, except that Mikart
shall reimburse Horizon for the costs of such recall (including
reimbursing Horizon for the Product at the invoice prices paid by
Horizon therefor) in the Territory to the extent such recall results
from the manufacture, packaging or storage of such Product by Mikart.
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(e) Each party hereto shall promptly notify the other of any
recall of either Product which has been directed by it or by any
governmental or regulatory entity or agency for any reason whatsoever.
Such notice shall identify the reason for the recall and all relevant
details thereof.
(f) Each party hereto shall promptly deliver to the other a
copy of all notices received by it from the FDA during the term of
this Agreement relating to the manufacture, packaging, storage or sale
of the Products.
(g) Upon the reasonable advance request of Horizon, Mikart
shall permit a representative of Horizon to inspect its facilities
where the Products are manufactured, packaged and stored, provided
such representative first executes a copy of Mikart's standard visitor
confidentiality agreement.
3.4 PACKAGING MATERIALS. Mikart shall order from time to time, at
Horizon's request and expense, labels, package inserts and other packaging
materials in sufficient quantities to permit the packaging of the Products
ordered by Horizon from time to time hereunder.
3.5 TRADEMARKS. Mikart acknowledges that the trademarks "Robinul"
and "Robinul Forte" (the "Trademarks") are registered trademarks licensed to
Horizon. Mikart further agrees not to use either of such trademarks except as
specifically authorized by Horizon under this Agreement in connection with the
manufacture, packaging and sale of the Products to Horizon.
ARTICLE 4
ORDERS AND SALES
4.1 FORECASTS. Commencing on the Qualification Date, and
thereafter at least thirty (30) days prior to the commencement of each calendar
quarter, Horizon shall provide Mikart with a non-binding, rolling twelve (12)
month forecast of its requirements for the Products.
4.2 PURCHASE ORDERS. Horizon shall place its orders for the
Products no later than ninety (90) days prior to the requested delivery date
using separately numbered, written purchase orders. Each purchase order must be
for one or more full Batches (provided Horizon shall have the right to specify
the size packaging requirements of each order from among 100 tablet bottles and
any other package sizes agreed to by the parties hereto). Purchase orders shall
be transmitted to Mikart via U.S. mail, private courier, or facsimile
transmission. Each purchase order shall include complete and accurate
information with respect to the requested Product, quantity, sizes, shipment
dates, shipment method and delivery destination. Subject to this Section 4.2,
Mikart will ship Product within five (5) days after the requested shipment date
in the corresponding purchase order. Mikart shall promptly notify Horizon upon
its receipt of any purchase orders containing shipment dates which need to be
rescheduled, and Mikart and Horizon shall work together in good faith to
schedule a new shipment date for such order (which shall not be later than
thirty (30) days after the date requested by Horizon). In addition, Horizon may
postpone a requested shipment date by providing Mikart at least sixty (60) days
prior written notice thereof.
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[***] - CONFIDENTIAL TREATMENT REQUESTED
4.3 MINIMUM PURCHASE. During each Contract Year, Horizon shall
purchase from Mikart the following minimum number of aggregate Batches of
Products:
Contract Year Minimum Batches
------------- ---------------
1 [***]
2 [***]
3 [***]
4 [***]
5 [***]
ARTICLE 5
PRICES, TERMS OF PAYMENT
5.1 PRICE. The prices to be paid for the Products by Horizon to
Mikart for shipments made during the first year after the Effective Date shall
be based on a Glycopyrrolate price of $12,000 per kilogram and are set forth
below; provided, however, in the event Mikart's price for Glycopyrrolate
changes in any material manner, the price of the Products shall be increased or
decreased (as the case may be) to reflect such change.
FOR ROBINUL: Size Price
100 tablet $[***]
FOR ROBINUL FORTE: Size Price
100 tablet $[***]
Notwithstanding anything else contained herein to the contrary, within thirty
(30) days after the end of any Contract Year in which Horizon purchases less
than [***] Batches, Horizon shall pay to Mikart an amount equal to the product
of (a) $[***] multiplied by (b) the difference between (i) [***] and (ii) the
number of Batches actually purchased by Horizon in such Contract Year.
5.2 PRICE ADJUSTMENTS. Mikart shall have the right to increase
the prices charged for the Products pursuant to Section 5.1 hereof one time
during each year after the Effective Date to reflect any increase in the costs
of goods and services necessary to manufacture the Product ("Total Product
Costs'); provided, however, in the event Mikart so increases such prices in any
such year and after the effective date thereof, Mikart's cost of raw materials
or components for manufacturing the Products ("Materials Cost") further
increases by more than five percent (5%) during such year, Mikart shall have
the right, by providing at least sixty (60) days written notice to Horizon to
further increase such prices in such year by a percentage amount equal to the
percentage increase in Total Product Costs that are attributable to the
percentage increase in Materials Cost in excess of five percent (5%); provided
further, that Mikart shall provide Horizon with documented evidence of any such
additional cost increases and shall use its reasonable efforts to prevent any
such cost increases from occurring. In addition, Mikart shall reduce its prices
charged hereunder to reflect any material decrease in the prices paid by it for
the active ingredient raw materials used to manufacture the Products.
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5.3 PAYMENT TERMS. Mikart shall invoice Horizon for the price of
the Products sold at the time of shipment, and Horizon shall pay each such
invoice within thirty (30) days after its receipt thereof.
5.4 EXCLUSIVITY. Horizon shall not purchase either Product from
any person or entity other than Mikart during the term hereof without the prior
written consent of Mikart, which consent must specifically state that Mikart is
consenting to waive its exclusive rights hereunder. However, in the event that
Mikart notifies Horizon in writing that it will not or cannot supply any
Products ordered by Horizon in accordance with the terms hereof, or in the
event that Mikart has failed to deliver any Products ordered by Horizon within
the period of time required under Section 4.2 (exclusive of any cure period
provided by Section 7.2(a)), then Horizon may purchase a product identical to
that of such Product in the quantity specified in the unfilled purchase order
from any available alternate source without fast obtaining the written consent
required above. In the event Horizon is permitted to purchase Product from any
person or entity other than Mikart in accordance with this Section 5.4, any
amounts so purchased by Horizon shall apply toward the minimum batch purchase
obligations set forth in Section 4.3 for such year, and, upon Horizon's
request, Mikart shall provide reasonable assistance to enable such other person
or entity to manufacture the Products under the Health Registrations (provided
Mikart shall not be required to pay any out-of-pocket costs or expenses in
connection therewith). In the event that said notice or failure occurs on two
or more occasions within a one hundred eighty (180) day period, this Section
5.4 shall no longer be of any force or effect and Horizon shall be relieved of
its obligations pursuant to Section 4.3 hereof. Nothing in this Section 5.4
shall be construed so as to limit or eliminate any other remedies available to
Horizon in the event of a breach of Mikart's obligations under this Agreement,
including its obligation to manufacture, package and deliver the Products
ordered by Horizon.
ARTICLE 6
SHIPPING DEFECTS, RETURNS
6.1 SHIPPING. Mikart will ship all Products ordered hereunder to
Horizon f.o.b. Mikart's manufacturing facility, at which point the risk of loss
for such Products will pass to Horizon. Title to such Products shall pass to
Horizon only upon Mikart's receipt of payment in full therefor. Mikart shall
ship the Products to the location designated by Horizon on its purchase order.
The parties agree that the method and route of shipment are at Mikart's
discretion unless Horizon furnishes Mikart explicit instructions with the
purchase order. Horizon agrees to pay all costs of shipping and any costs of
freight insurance obtained by Mikart at the request of Horizon. Mikart agrees
to provide reasonable support to assist Horizon in pursuing any claims it may
have against carriers.
6.2 NOTIFICATION OF DEFECTS. Horizon shall notify Mikart in
writing as soon as reasonably practicable after delivery to Horizon of any
non-conforming Product containing obvious defects in such Product discoverable
without affecting the integrity of such Product's packaging (but in any event
within twenty (20) days after delivery) and within thirty (30) days of the
earlier of its discovery or its notification by a third party of any latent
defects. Horizon shall be responsible for its costs to inspect all Products.
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6.3 RETURNS. Mikart shall accept for return and replacement or
credit (at invoiced cost) any Product sold to Horizon under this Agreement
which does not conform with the warranties set forth herein and for which
proper notice has been given in accordance with Section 6.2, provided Horizon
obtains prior shipping authorization from Mikart. All returns of Products with
obvious defects must be in the original manufactured condition. Mikart will pay
reasonable return freight and shipping charges, but Horizon shall assume the
risk of loss in transit associated with such returns.
ARTICLE 7
TERM AND TERMINATION
7.1 TERM. Unless earlier terminated in accordance with the
provisions hereof, the term of this Agreement shall commence on the Effective
Date and shall thereafter continue in effect until the fifth (5th) anniversary
of the Qualification Date (the "Initial Term"). At the end of the Initial Term
and each subsequent "Renewal Term" (as hereinafter defined), the term of this
Agreement shall be automatically renewed and extended for a one (1) year period
(a "Renewal Term'), unless either party delivers a written termination notice
to the other party at least six (6) months prior to the end of the Initial Term
or the then current Renewal Term, as the case may be.
7.2 TERMINATION. Either party may terminate this Agreement on
written notice to the other party, effective immediately if:
(a) the other party commits a material breach of any of its
obligations hereunder which is not cured within sixty (60) days of
written notice from the other party specifying the breach;
(b) the other party is dissolved or liquidated, files or has
filed against it a petition under any bankruptcy or insolvency law,
makes an assignment to the benefit of its creditors, has a receiver
appointed for all or substantially all of its property, or has a
petition under any bankruptcy or insolvency law filed against it which
is not dismissed within sixty (60) days; or
(c) the Qualification Date has not occurred within two (2)
years after the Effective Date.
Such right of termination shall be in addition to any other remedy a
non-defaulting party may have at law or in equity due to the other party's
breach of is obligations hereunder.
7.3 POST-TERMINATION RESTRICTIONS. Upon any expiration or
termination of this Agreement (other than by Horizon pursuant to Section 7.2),
Horizon shall grant Mikart at least sixty (60) days to produce all open orders
in house in accordance with the conditions of the open orders and this
Agreement. In the event Horizon terminates this Agreement pursuant to Section
7.2: (a) Mikart shall not manufacture, package or sell to any other person or
entity for a period of two (2) years thereafter any product Mikart is
prohibited from making during the term of this Agreement pursuant to Section
3.1; and (b) upon the request of Horizon, Mikart will provide Horizon with
reasonable assistance in locating or establishing a new manufacturer for the
Products.
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7.4 CHANGED CIRCUMSTANCES. In the event that the market for the
Products materially changes or either party, in good faith, believes that a
material change in such party's circumstances beyond their control has occurred
which materially affects its ability to perform its obligations pursuant to
this Agreement, the parties hereto shall, in good faith, negotiate towards
mutually acceptable revisions to this Agreement to address the impact of such
material changes; provided, however, the terms of this Agreement shall continue
in full force and effect unless and until the parties hereto agree otherwise.
7.5 FORCE MAJEURE.
(a) The failure of either of the parties hereto to perform
any obligation under this Agreement solely by reason of any cause
beyond its control (and due to no fault of its own), including,
without limitation, acts of God, acts of government, riots, wars,
strikes and accidents in transportation, shall not be deemed to be a
breach of this Agreement; provided, however, that the party so
prevented from complying herewith shall continue to take all actions
within its power, including payment of outstanding invoices, to comply
as fully as possible herewith.
(b) If, due to force majeure, Mikart is prevented or expected
to be prevented from supplying Horizon with the Products for a period
exceeding one hundred twenty (120) days, then Horizon shall have the
right to terminate this Agreement with immediate effect and upon the
request of Horizon at Horizon's expense Mikart will provide reasonable
assistance in establishing or locating a new manufacturer for the
Products. Likewise, should Horizon be unable to purchase the Products
for a period exceeding one hundred twenty (120) days, then Mikart
shall have the right to terminate this Agreement, provided Horizon
shall remain obligated to pay to Mikart any amounts owed hereunder.
7.6 SPECIAL TERMINATION. Notwithstanding anything else contained
herein to the contrary, but subject to Section 7.5, in the event Horizon fails
in any Contract Year to meet its minimum Batch purchase requirements set forth
in Section 4.3 hereof for any reason other than a breach of this Agreement by
Mikart, then Mikart shall have the right to terminate this Agreement effective
immediately by delivering written notice thereof to Horizon; provided, however,
Horizon may apply purchases in excess of the minimum Batch purchases in any
Contract Year to meet such requirements in subsequent Contract Years.
7.7 POST-TERMINATION OBLIGATIONS. Notwithstanding anything else
contained herein to the contrary, following any termination or expiration of
this Agreement:
(a) Mikart, at its option, shall either deliver the Blender
to Horizon (in which case Horizon shall assume all of Mikart's
remaining obligations under its lease therefor) or pay to Horizon
amount in cash equal to the then-current net book value of the
Blender;
(b) Horizon shall purchase from Mikart (at Mikart's cost
therefor) all of Mikart's remaining inventory of the active ingredient
in the Products (but only to the extent necessary to manufacture the
Products equal to Horizon's forecast for the subsequent four (4) month
period); and
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(c) Subject to Section 7.3 hereof, Mikart shall have not
further rights to use any of the Health Registrations.
ARTICLE 8
INDEMNIFICATION AND INSURANCE
8.1 INDEMNIFICATION. Mikart hereby indemnifies and agrees to
defend and hold Horizon harmless from and against losses, claims, damages,
liabilities, costs and expenses (including, without limitation, attorneys' fees
and court costs) incurred by Horizon as a result of any breach of this
Agreement by Mikart or the manufacture, package or storage of any Products by
Mikart. Horizon hereby indemnifies and agrees to defend and hold Mikart
harmless from and against losses, claims, damages, liabilities, costs and
expenses (including, without limitation, attorneys' fees and court costs)
incurred by Mikart as a result of any breach of this Agreement by Horizon, the
storage, sale or distribution of the Products, or any failure by Horizon to
provide any instructions regarding the proper use of the Products to any user
thereof.
8.2 INSURANCE. Each party hereto shall maintain with a
financially sound and reputable insurer throughout the term of this Agreement
comprehensive general liability insurance, including, without limitation,
product liability insurance with liability limits of at least $5,000,000 per
occurrence and in the aggregate. Each party hereto shall also name the other
party as an additional insured party on its policy and provide the other party
with such evidence thereof as is reasonably requested by the other party from
time to time.
ARTICLE 9
WARRANTIES AND REPRESENTATIONS OF THE PARTIES
9.1 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF MIKART. Mikart
hereby additionally represents and warrants to Horizon the following:
(a) Mikart is a corporation duly organized and existing in
good standing under the laws of the State of Georgia;
(b) There are no material adverse claims pending or, to the
best of Mikart's knowledge, threatened against Mikart by any entity
with respect to the Products;
(c) Mikart is neither a party to nor otherwise bound by any
agreement or instrument which prohibits or prevents it from performing
its obligations under this Agreement; and
(d) Mikart's manufacturing, packaging and storage facilities
comply in all material respects with all applicable federal, state and
local laws, rules and regulations in the Territory.
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(e) Mikart is using a combination of internal and external
resources to assess and make any necessary changes to its information
technology systems to ensure that they will function without error in
connection with the date January 1, 2000. Mikart has communicated with
(and will continue to communicate with) its suppliers and others with
whom it does business to monitor and evaluate such "Year 2000"
conversion.
Nonetheless, Mikart does not expect such conversion to have a material adverse
effect on its ability to perform its obligations under this Agreement.
9.2 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF HORIZON.
Horizon hereby additionally represents and warrants to Mikart the following:
(a) Horizon is a corporation duly organized and existing
under the laws of the State of Delaware;
(b) There are no material adverse claims pending or, to the
best of Horizon's knowledge, threatened against Horizon by any entity
with respect to any of its products or business;
(c) Horizon is neither a party to nor otherwise bound by any
agreement or instrument which prohibits or prevents it from performing
its obligations under this Agreement; and
(d) Horizon owns all of the Health Registrations and holds a
valid license to use the Trademarks and has the full power and
authority to grant to Mikart the right to manufacture and purchase the
Products under the Health Regulations and to use the Trademarks in
connection therewith, all in accordance herewith.
ARTICLE 10
CONFIDENTIALITY AND NONSOLICITATION OF PERSONNEL
10.1 CONFIDENTIALITY. Each party hereto acknowledges that it has
been and will be exposed to certain "Confidential Information" and "Trade
Secrets" (both as hereinafter defined) of the other party in connection with
the transactions contemplated by this Agreement and that its unauthorized use
or disclosure of such information or data could cause immediate and irreparable
harm to such other party. Accordingly, except to the extent that it is
necessary to use such information or data to perform its obligations under this
Agreement, neither party shall, without the express prior written consent of
the other party, redistribute, market, publish, disclose or divulge to any
person or entity, or use or modify for use, directly or indirectly, in any way
for any person or entity: (a) any of the other party's Confidential Information
during the term of this Agreement and for a period of three (3) years after any
expiration or termination of this Agreement; and (b) any of the other party's
Trade Secrets at any time during which such information constitutes a trade
secret under applicable law. For purposes hereof, "Confidential Information"
shall mean all competitively sensitive, non-public information (other than
"Trade Secrets") of or about a party which is not generally known by or
available to such party's competitors, and "Trade Secrets" shall mean "Trade
Secrets" as defined under applicable law.
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10.2 NONSOLICITATION OF PERSONNEL. Neither party hereto shall,
without the prior written consent to the other party, either directly or
indirectly, alone or in conjunction with any other person or entity, solicit or
attempt to solicit any "key or material" employee, consultant, contractor or
personnel of such other party in the State of Georgia to terminate, alter or
lessen his or her affiliation with such other party at any time during the term
of this Agreement and for a period of one (1) year thereafter.
ARTICLE 11
ARBITRATION OF DISPUTES
All disputes arising out of or in connection with the interpretation,
application or enforcement of this Agreement shall be settled by final and
binding arbitration. Such arbitration shall be conducted in Atlanta, Georgia,
pursuant to the commercial arbitration rules of the American Arbitration
Association in effect at the time the arbitration is commenced. The decision of
the arbitrators, which may include interest, shall be final and binding on the
parties hereto and may be entered and enforced in any court of competent
jurisdiction by any party. The arbitration shall be pursued and brought to
conclusion as rapidly as possible. The prevailing party in the arbitration
proceeding shall be awarded reasonable attorneys' fees, expert witness costs
and expenses, and all other costs and expenses incurred in connection with such
proceeding, unless the arbitrators shall for good cause determine otherwise.
ARTICLE 12
NOTICES
12.1 DELIVERY. All notices, consents, requests and other
communications hereunder shall be in writing and shall be sent by hand
delivery, by certified or registered mail (return-receipt requested), or by a
recognized national overnight courier service as set forth below:
If to Mikart: Mikart, Inc.
0000 Xxxxxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxx 00000
Attention: Xxxxxx X. Xxxxxxx
If to Horizon: Horizon Pharmaceutical Corporation
000 Xxxxxxx Xxxxxxx
Xxxxx 000
Xxxxxxx, Xxxxxxx 00000
Attention: Xxxxx Xxxxx
12.2 EFFECTIVE TIME. Notices delivered pursuant hereto shall be
deemed given: (a) at the time delivered, if personally delivered; (b) at the
time received, if mailed; and (c) one (1) business day after timely delivery to
the courier, if by overnight courier service.
12.3 CHANGES. Either party hereto may change the address to which
notice is to be sent by written notice to the other party in accordance with
the provisions of this Article 12.
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ARTICLE 13
MISCELLANEOUS
13.1 SEVERABILITY. If any provision of this Agreement is held to
be invalid, illegal or unenforceable, the validity, legality and enforceability
of the remaining provisions shall not in any way be affected or impaired, and
the parties shall use their best efforts to substitute a valid, legal and
enforceable provision, which, insofar as practical, implements the purpose of
this Agreement.
13.2 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall be deemed one and the same instrument.
13.3 GOVERNING LAW. This Agreement shall be governed by, and any
matter or dispute arising out of this Agreement shall be determined by, the
laws of the State of Georgia.
13.4 HEADINGS: GENDER. "Article," "Section" and other headings
contained in this Agreement are for reference purposes only and shall not
affect in any way the meaning or interpretation of this Agreement. All personal
pronouns used in this Agreement shall include the other genders, whether used
in the masculine, feminine or neuter gender, and the singular shall include the
plural and vice versa, whenever and as often as may be appropriate.
13.5 ENTIRE AGREEMENT. This Agreement represents the entire
agreement of the parties with respect to its subject matter. Any and all prior
discussions or agreements with respect hereto are merged into and superseded by
the terms of this Agreement. This Agreement may be modified or amended only in
writing signed by both parties which expressly refers to this Agreement and
states an intention to modify or amend it. No such amendment or modification
shall be effected by use of any purchase order, acknowledgment, invoice or
other form of either party and in the event of conflict between the terms of
this Agreement and any such form, the terms of this Agreement shall control.
13.6 NOTICES. Any notice or payment required or permitted hereunder
shall be in writing and sent by certified mail, overnight express, or
personally delivered, addressed to the party to receive the notice as set out
below.
13.7 NO ASSIGNMENT. Neither party hereto may assign this Agreement,
in whole or in part, without the prior written consent of the other party
(which consent shall not be unreasonably withheld or delayed), and any
attempted assignment not in accordance herewith shall be null and void and of
no force or effect.
13.8 BINDING EFFECT. This Agreement shall be binding upon and shall
inure to the benefit of the parties hereto and their respective successors,
heirs, representatives and permitted assigns.
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13.9 INTERPRETATION. This Agreement was fully negotiated by both
parties hereto and shall not be construed more strongly against either party
hereto regardless of which party is responsible for its preparation.
13.10 NO CONSEQUENTIAL DAMAGES. Neither party to this Agreement
shall have any liability to the other party for any consequential or indirect
damages arising out of any breach of this Agreement, including, without
limitation, loss of profit, loss of use or business stoppage.
13.11 FURTHER ASSURANCES. Upon the reasonable request of the other
party, each party hereto agrees to take any and all actions necessary or
appropriate to give effect to the terms set forth in this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused their duly
authorized representatives to execute this Agreement as of the day and year
first above written.
"Mikart"
MIKART, INC.
By:
---------------------------------
Xxxxxx X. Xxxxxxx, President
"Horizon"
HORIZON PHARMACEUTICAL
CORPORATION
By:
---------------------------------
Xxxxx Xxxxx, President
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EXHIBIT A: PRODUCT SPECIFICATIONS
ROBINUL(R) TABLETS (GLYCOPYRROLATE 1 MG)
Description: White, round, flat beveled tablet debossed with "HPC 200"
on one side and bisect on other side.
Assay: 93 - 107% of label claim
Content Uniformity: USP limits
ROBINUL(R) FORTE TABLETS (GLYCOPYRROLATE 2 MG)
Description: White, round, flat beveled tablet debossed with "HORIZON"
and "205" with bisect on one side and no debossing on other side.
Assay: 93 - 107% of label claim
Content Uniformity: USP limits
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