Exhibit 10
CONFIDENTIAL TREATMENT REQUESTED
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 MANUFACTURNG AND SUPPLY AGREEMENT (the "Agreement" ) is made and
entered into this 21st day of January, 2001 (the "Effective Date"), by and
between FIRST 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 "Product" (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 "Approval Date" shall mean the date on which the FDA issues as approval
letter granting approval of an NDA or sNDA for the Product.
1.2 "Batch" shall mean [***] liters of the Product unless otherwise
specified by Horizon.
1.3 "cGMP" and "current Good Manufacturing Practices" shall mean the
regulatory standards and the principles and guidelines of good manufacturing
practice, as in effect from time to time, relating to the manufacture of
medicinal products including, but not limited to, standards for equipment,
facilities, production and quality control established by the applicable
governmental or regulatory authority.
1.4 "Completion Date" shall mean October 15, 2001.
1.5 "Contract Year" shall mean a twelve (12) consecutive month period after
the Approval Date and during the term of this Agreement. The first Contract Year
shall commence as of the Approval Date, and subsequent Contract Years shall
commence on each anniversary of the Approval Date.
1.6 "FDA" shall mean the United States Food and Drug Administration or any
successor agency thereof.
1.7 "Health Registrations" shall mean the NDA or sNDA to be approved by the
FDA with respect to the Product and any other governmental or regulatory
consents, registrations, approvals or permits necessary to sell or manufacture
the Product in the Territory.
1.8 "NDA Stability Batch" shall mean Product manufactured for the purpose
of generating stability and process validation data to be included in the NDA or
sNDA., and which is not intended for commercial sale.
1.9 "Product" shall mean Glycopyrrolate 1 mg per 5 mL (regardless of how
packaged).
1.10 "Specifications" shall mean the specifications for manufacturing,
packaging and labeling to be set forth in the NDA or sNDA for the Product.
1.11 "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 2.5.
ARTICLE 2
VALIDATION AND TESTING
2.1 General. Mikart shall become authorized to manufacture and package the
Product under the Health Registrations in specified containers containing the
amount of Product designated in Section 5.1 or otherwise requested by Horizon.
To accomplish the same, Mikart shall develop a manufacturing process and prepare
on behalf of Horizon for the FDA and any other applicable agency or authority
the chemistry, manufacturing and control portions of the Health Registrations
which, when and if approved, would permit Mikart to manufacture the Product
pursuant to this Agreement. No later than the Completion Date, Mikart shall have
completed all undertakings required of it hereunder which will be required in
the NDA or sNDA for the Product. Mikart's obligation to complete its
undertakings hereunder by the Completion Date is a material provision of this
Agreement.
2.2 Validation. No later than March.15, 2001, Mikart shall have completed
analytical methods validation with respect to the Product and shall have
prepared documentation pertaining to the same as is necessary for the Health
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Registrations. No later than the date that is forty-five (45) days after the
manufacture of the third (3rd) NDA Stability Hatch, Mikart shall have evaluated
the analytical data for the three NDA stability batches using its process
validation acceptance criteria.
2.3 Testing. Mikart will conduct stability testing on the Product as
required by federal law. Mikart shall charge Horizon $[***] per stability sample
tested (which testing shall include organopleptic, assay, preservative assay,
related substances and pH). Such charges shall be paid by Horizon within thirty
(30) days of receipt of an invoice therefor. No later than the Completion Date,
the then current stability summary forms shall have been completed by Mikart
which shall include the results of at least 6 (six) months of accelerated and
controlled room temperature stability testing, and be in a form sufficient for
filings for the Health Registrations.
2.4 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 Product for Horizon pursuant to this Agreement.
2.5 Additional Locations. In the event Horizon desires to market,
distribute or sell the Product in any location not set forth in Section 1.11 (or
previously designated pursuant to this Section 2.5), then Mikart shall, at
Horizon's request, cooperate in good faith with Horizon to enable Horizon to
obtain any Health Registrations necessary or appropriate therefor, and
manufacture the Product to be marketed, distributed and sold in such locations
(and Horizon shall pay all of Mikart's incremental reasonable out-of-pocket
expenses therefor); provided, however, Horizon shall not market, distribute or
sell any Product in such locations unless and until it obtains such Health
Registrations.
2.6 Proprietary Information. Mikart hereby agrees to make available to
Horizon all data (including any clinical data), formulas, methodologies,
packaging configurations and other propriety information, whether currently
existing or arising hereafter, exclusively associated with the Product,
including such items developed pursuant to the Product Development Agreement
between the parties having a Quote Date of October 13,1999 (the "Proprietary
Information"), that are necessary for Horizon to obtain an NDA or sNDA for the
Product. Mikart shall not use the Proprietary Information or disclose the
Proprietary Information in connection with the development of or efforts to
obtain approval for a product that is directly competitive to the Product.
ARTICLE 3
MANUFACTURE
3.1 Exclusivity. Subject to the terms and conditions contained herein,
throughout the term of this Agreement, Mikart shall manufacture, package and
sell the Product exclusively to Horizon and Horizon shall purchase exclusively
from Mikart all of Horizon's requirements of the Product subject to the terms
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and conditions of this Agreement. 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 is 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 Product is
or becomes approved. Horizon shall promptly notify Mikart in writing of any
indications for the Product for which Horizon anticipates seeking approval.
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.
3.2 Limited Warranties. Mikart hereby represents and warrants to Horizon
that the Product manufactured and sold to Horizon hereunder shall conform to the
Specifications and shall be free of all defects in materials and workmanship.
The Product, 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 AND SECTION 9.1, MIKART MAKES NO OTHER REPRESENTATIONS
OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE PRODUCT 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 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 Product in
accordance with normal industry standards to determine whether such Product
conforms 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 Product which
is reasonably requested by Horizon and promptly provide Horizon with the
results thereof; provided, however, Horizon shall not be responsible far
the expenses associated with any such testing which shows that such Product
does not meet the Specifications.
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(b) In addition, Mikart shall be responsible for conducting an ongoing
stability program for the Product as required by federal law. Mikart shall
provide the results of such testing to Horizon in a manner as this data is
generated or received by Mikart. Mikart shall charge Horizon $[***] per
stability sample tested (which testing shall include organoleptic, assay,
preservative assay, related substances and pH). Such charges shall be paid
by Horizon within thirty (30) days of receipt of an invoice therefor.
(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 incurred as a result of such recall (including
reimbursing Horizon for costs reasonably expended by Horizon to identify
the defect (e.g. testing) and 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; the
failure of the Product to meet the Specifications; or the failure of Mikart
to comply with cGMP. In any event, Mikart will cooperate as reasonably
required in Horizon's efforts.
(e) Each party hereto shall promptly notify the other of any recall of
the 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 Product.
(g) Upon the reasonable advance request of Horizon, Mikart shall
permit a representative of Horizon to inspect its facilities where the
Product is 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 Product ordered by Horizon
from time to time hereunder.
3.5 Trademark. Mikart acknowledges that Horizon will be the owner or
licensee of all the trademarks in connection with the Product, whether pending,
registered or pursuant to common law (the "Trademarks"). Mikart agrees not to
use the Trademarks except as specifically authorized by Horizon under this
Agreement in connection with the manufacture, packaging and sale of the Product.
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3.6 Active Pharmaceutical Ingredient. Only Horizon shall arrange or
contract with supplier(s) of Glycopyrrolate to supply Glycopyrro-late for the
manufacture of the Product. Mikart shall purchase such Glycopyrrolate from such
supplier(s) only pursuant to such contract or arrangement and on behalf of
Horizon.
ARTICLE 4
ORDERS AND SALES
4.1 Forecasts. Commencing at least one hundred and twenty (120) days prior
to the first date on which the Product is to be delivered by Mikart to Horizon
for commercial sale, 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
Product.
4.2 Purchase Orders. Horizon shall place its orders for the Product 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 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 quantity, sizes, shipment dates, shipment method and delivery destination
for the Product. Subject to this Section 4.2, Mikart will ship Product within
fourteen (14) 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.
4.3 Minimum Purchase. Horizon shall purchase from Mikart the following
minimum number of aggregate Batches of Product based on Batches being [***]
liters:
Period Minimum Batches
------ ---------------
Prior to and including Contract Year 1 [***]
Contract Year 2 [***]
Contract Year 3 [***]
Contract Year 4 [***]
Contract Year 5 [***]
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ARTICLE 5
PRICES, TERMS OF PAYMENT, EXCLUSIVITY
5.1 Price. The prices to be paid for the Product by Horizon to Mikart for
shipments made during the first year after the Effective Date shall be based on
a Glycopyrrolate price of $[***] 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 Product shall be increased or decreased (as the case
may be) to reflect such change.
1 oz bottle $[***]
4 oz bottle $[***]
16 oz bottle $[***]
5.2 Price Adjustments. Mikart shall have the right to increase the prices
charged for the Product 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 Product ("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 Product.
5.3 Payment Terms. Mikart shall invoice Horizon for the price of the
Product 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 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 Product
ordered by Horizon in accordance with the terms hereof, or in the event that
Mikart has failed to deliver any Product 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 the
Product in the quantity specified in the unfilled purchase order from any
available alternate source without first obtaining the written consent required
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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 Sections 4.3 and 3.1 for such year or for subsequent years pursuant
to Section 7.6 hereof, and, upon Horizon's request, Mikart shall provide
reasonable assistance to enable such other person or entity to manufacture the
Product 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 Product ordered by Horizon.
5.5 Back-up Manufacturer. Notwithstanding anything in this Agreement to the
contrary, Horizon may purchase three conforming exhibit batches of Product from
a manufacturer other than Mikart to enable such other manufacturer to become
qualified to manufacture the Product under the Health Registrations.
ARTICLE 6
SHIPPING DEFECTS, RETURNS
6.1 Shipping. Mikart will ship all Product ordered hereunder to Horizon
f.o.b. Mikart's manufacturing facility, at which point the risk of loss for such
Product will pass to Horizon. Title to such Product shall pass to Horizon only
upon Mikart's receipt of payment in full therefor. Mikart shall ship the Product
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 Product.
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 Product with obvious defects
must be in the original manufactured condition. Mikart will pay reasonable
return freight and shipping charges, but Horizon shill assume the risk of loss
in transit associated with such returns.
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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 earliest to occur of (a) the fifth
(5th) anniversary of the Approval Date (the "Initial Term") or the end of the
last Renewal Term (as hereinafter defined), as the case may be, or (b)
termination of this Agreement pursuant to Section 72. At the end of the Initial
Term and each subsequent "Renewal Term", 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;
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 its 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 or 7.5: (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 Product.
7.4 Changed Circumstances.
(a) In the event that the market for the Product 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
(including, without limitation, the failure to receive an approval of an
NDA or sNDA for the Product from the FDA within three (3) years of the
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Effective Date), 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.
(b) During the performance of its obligations hereunder, in the event
Mikart discovers a degradant in the Product; (i) Mikart shall promptly
notify Horizon of such fact and shall use its commercially reasonable
efforts to minimize or prevent any delays and increased expense
necessitated thereby; and (ii) the parties shall avail themselves of the
procedures described in Section 7.4(a) above.
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 Product 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 Product. Likewise,
should Horizon be unable to purchase the Product 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
period 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) Horizon shall purchase from Mikart (at Mikart's cost therefor) all
of Mikart's remaining inventory of the active ingredient in the Product
(but only to the extent necessary to manufacture Product equal to Horizon's
forecast for the subsequent four (4) month period); and
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(b) 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 Product 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 Product, or any failure by Horizon to provide any instructions regarding the
proper use of the Product 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 $3,000,000 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 that would
prohibit Mikart from performing its obligations under this Agreement;
(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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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 issued as of the
Effective Date and will be the owner or licensee of the Trademarks and has
the full power and authority to grant to Mikart the right to manufacture
and purchase the Product 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.
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
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affiliation with such other party at any time during the term of this Agreement
and for a period of [***] 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: Xxxxx X. XxXxxxxx
If to Horizon: First 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, provided however, that no consent shall be required in the event of an
assignment arising from a merger or acquisition of a party hereto.
13.8 Relationship of Parties. It is not the intent of the parties to form
any partnership or joint venture. Each party will, in relation to its
obligations hereunder, act as an independent contractor, and nothing in this
Agreement will be construed to give either party the power or authority to act
for, bind or commit the other party in any way whatsoever.
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13.9 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.
13.10 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.
13.11 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.
13.12 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" "Horizon"
MIKART, INC. FIRST HORIZON PHARMACEUTICAL
CORPORATION
By: /s/ Xxxxx X. XxXxxxxx By: /s/ Xxxxxx Xxxxxxxxxxxx
------------------------------- ------------------------------------
Xxxxx X. XxXxxxxx, President Title: EVP and CFO
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