Exhibit 10.22
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (the "Agreement") is entered into as of January 4,
2002, by and between AKORN, INC. a Louisiana corporation with its principal
offices at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxxxx 00000 ("AKORN") and
NOVADAQ TECHNOLOGIES, INC., a Canadian corporation with its principal place of
business at 000 Xxx Xxxx Xxxx, Xxxxx 000, Xxxxxxx, Xxxxxx X0X 0X0 ("NOVADAQ").
AKORN and NOVADAQ may each be referred to herein individually as a "Party" and
collectively as the "Parties."
In consideration of the mutual premises, covenants and conditions contained in
this Agreement, the Parties agree as follows:
1. DEFINITIONS
As used in this Agreement, the following terms shall have the following
respective meanings:
"ACCEPTABLE PRODUCT" shall have the meaning set forth in Section 5.1
hereof.
"AFFILIATE" shall mean, in the case of either Party, any corporation,
joint venture, or other business entity, which directly or indirectly
controls, is controlled by, or is under common control with that Party.
"Control", as used in this definition, shall mean having the power to
direct, or cause the direction of, the management and policies of an
entity, whether through ownership of voting securities, by contract or
otherwise. Notwithstanding the foregoing, for purposes of this Agreement,
the term "Affiliate" shall not include subsidiaries in which a Party or
its Affiliates owns a majority of the ordinary voting power to elect a
majority of the board of directors but is restricted from electing such
majority by contract or otherwise, until such time as such restrictions
are no longer in effect.
"AKORN KNOW-HOW" shall mean all proprietary technical and clinical
information, data and know-how relating to the manufacture of the Product,
whether or not patentable, owned or controlled, as of the Effective Date
or acquired during the term of this Agreement, by AKORN or its Affiliates.
AKORN Know-How shall include, without limitation, all processes, formulas,
discoveries and inventions whether relating to biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and analytical
safety or quality control data. The term "AKORN Know-How", however, shall
not include (i) any know-how, processes, information and data which is, as
of the Effective Date or later becomes, generally available to the public
or (ii) any general manufacturing know-how not specific to the Product.
"CALENDAR QUARTER" shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30 or
December 31, for so long as this Agreement is in effect.
"CERTIFICATE OF ANALYSIS" shall mean the certificate for each batch of
Product delivered hereunder in the form contemplated by Section 3.1 of
this Agreement.
"cGMP" shall mean current good manufacturing practices of the FDA,
including compliance with the FD&C Act, 21 C.F.R. parts 210 and 211 and
all applicable FDA rules, regulations, policies and guidelines in effect
at a given time.
"COMMERCIALLY REASONABLE EFFORTS" shall mean efforts and resources
normally used by a Party for a compound or product owned by it or to which
it has rights, which is of similar market potential at a similar stage in
its product life, taking into account the competitiveness of the
marketplace, the proprietary position of the compound or product, the
regulatory structure involved, the profitability of the applicable
products, and other relevant factors.
"DOLLARS" AND "$" shall mean lawful money of the United States unless
otherwise indicated.
"EFFECTIVE DATE" shall mean January 4, 2002.
"FDA" shall mean the United States Food and Drug Administration, and any
successor thereto.
"FD&C ACT" shall mean the United States Federal Food, Drug and Cosmetic
Act, as amended.
"HPB" shall mean the Health Protection Branch of Health Canada or any
successor or replacement entities thereof.
"GOVERNMENTAL BODY" shall mean (i) any domestic or foreign national,
federal, provincial, state, municipal or other government or body, (ii)
any international or multilateral body, (iii) any subdivision, ministry,
department, secretariat, bureau, agency, commission, board,
instrumentality or authority of any of the foregoing governments or
bodies, (iv) any quasi-governmental or private body exercising any
regulatory, expropriation or taxing authority under or for the account of
any of the foregoing governments or bodies, or (v) any domestic, foreign,
international, multilateral, or multinational judicial, quasi-judicial,
arbitration or administrative court, grand jury, tribunal, commission,
board or panel or other regulatory or governmental authority.
"ICG" shall mean indocyanine green complying with the specifications of
U.S. Pharmacopoeia 24 and FDA approved NDA.
"INDICATIONS" means NOVADAQ's use of ICG-C for angiography of arteries,
carotid arteries, intracranial vasculature, AV fistulas and the peripheral
vasculature, for the diagnosis and treatment of age-related macular
degeneration utilizing U.S. Patents #5,279,298 and #5,394,199 and all
corresponding foreign patents that are licensed by NOVADAQ from Xxxxx
Xxxxxxx University, or any other patents and technologies derived from the
foregoing patents, outside of the United States ("AMD"), and for such
other applications as may be mutually agreed to by the Parties.
"MATERIAL BREACH" means, in the case of AKORN, a breach of subsections
3(i), 3(ii), 3(iii) or 3(iv) of the Settlement and Mutual Release or any
failure by AKORN to supply, either directly or through Third Parties,
ICG-C in accordance with the terms and conditions of this Agreement,
including the specifications, where such failure shall continue for three
months and shall not be the result of a Material Breach of this Agreement
by NOVADAQ, or an event of force majeure as described in Section 12.1. In
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the case of NOVADAQ, "Material Breach" means the failure to make payment
or a series of payments of a minimum value of $50,000 or more, subject to
the terms of paragraph 12.9 hereof;
"PERMITTED MANUFACTURERS" shall have the meaning set forth in Section 2.2
hereof.
"PRODUCT" or "ICG-C" shall mean a human pharmaceutical product, of which
ICG is the sole active ingredient, and which conforms to the
Specifications and which is used in accordance with, or for the purposes
of, the Regulatory Approvals.
"REGULATORY APPROVALS" shall mean all (i) authorizations by the
appropriate Regulatory Authorities which are required for the marketing,
promotion, pricing and sale of the Product in the Territory, and (ii) new
drug applications ("NDAs") for the use of the Product in the Territory, as
applicable, for the Indications.
"REGULATORY AUTHORITY" shall mean any national, supra-national, regional,
state or local regulatory agency, department, bureau, commission, council
or other governmental entity in the Territory involved in the granting of
Regulatory Approval for the Product, including, without limitation, the
FDA and the HPB.
"SETTLEMENT AND MUTUAL RELEASE" shall mean the Settlement and Mutual
Release between AKORN and NOVADAQ dated January 4, 2002.
"SPECIFICATIONS" shall mean the specifications for or concerning the
manufacturing, testing, packaging and shipping of the Product as set forth
in the Schedule A hereto, or as may be agreed upon by the Parties in
writing from time to time.
"STORAGE PROTOCOL" shall mean that procedure and protocol prepared by
AKORN for the storage of Product, as such procedures and protocols shall
be amended from time to time.
"TERM" shall have the meaning set forth in Section 10.1 hereof.
"TERRITORY" shall mean the world, except in the case of NOVADAQ's Use for
the treatment of AMD, "Territory" shall mean the world excluding the
United States of America.
"THIRD PARTY(IES)" shall mean any person(s) or party(ies) other than
AKORN, NOVADAQ or their respective Affiliates.
2. SUPPLY OF PRODUCT
2.1 OBLIGATION TO SUPPLY. Subject to the provisions of this Agreement,
after the Effective Date and during the Term of this Agreement,
AKORN shall manufacture, or contract with Third Parties to have
manufactured, exclusively for and supply to NOVADAQ, Product for use
by NOVADAQ, its Affiliates or its permitted sub-licensees in the
Territory, and NOVADAQ shall exclusively purchase from AKORN its
entire requirements of Product for use in the Territory, in each
case for the Indications now or hereafter subject to this Agreement.
Prior to the Effective Date, AKORN shall supply NOVADAQ's
requirements for ICG-C for all clinical and pre-clinical trials on
the same terms as provided herein. All Product supplied under this
Agreement is to be supplied in finished form, as specified in
NOVADAQ's purchase orders placed with AKORN pursuant to
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Section 2.4 below. AKORN acknowledges NOVADAQ's ownership of all
rights in and to the Product and agrees not to sell or supply
Product to any Third Party without the express written consent of
NOVADAQ.
2.2 SUBCONTRACTING. For Product intended by NOVADAQ for sale in the
U.S., AKORN may subcontract or assign any part of its manufacturing
and supply obligations hereunder to any facility approved by FDA for
the manufacture of the Product, provided, however, that AKORN shall
notify NOVADAQ prior to transferring any manufacturing and supply
obligations to a subcontractor or assignee other than SP
Pharmaceutical, Inc. 0000 Xxxxxx Xxxx Xxxx, Xxxxxxxxxxx, XX 00000 or
Sigma-Xxxxxxx Fine Chemicals 0000 Xxxxxx Xx., Xx. Xxxxx, XX 00000.
For Product intended by NOVADAQ for sale outside the U.S., AKORN may
subcontract or assign any part of its manufacturing and supply
obligations hereunder to any facility approved by the relevant
Regulatory Authority for the manufacture of the Product. AKORN shall
provide NOVADAQ documentation demonstrating that any subcontractor's
or assignee's facility has been approved by the FDA (for Product
intended for sale in the U.S.) or the relevant Regulatory Authority
(for Product intended for sale outside the U.S.) for the manufacture
of the Product.
2.3 FORECASTS.
2.3.1 ROLLING FORECASTS. Throughout the term of this Agreement,
NOVADAQ shall provide AKORN with a rolling one (1) year
forecast (the "Forecast") of its expected purchases of the
Product, the mechanism for which shall be as follows:
(a) On or before the Effective Date, NOVADAQ shall have
provided AKORN with a written forecast of its expected
purchases of the Product for the period extending three
(3) Calendar Quarters beyond the Calendar Quarter
containing the Effective Date.
(b) Beginning on the date of the first Calendar Quarter
following the Effective Date and then on or prior to the
first day of each subsequent Calendar Quarter, NOVADAQ
shall provide AKORN with an update to its previously
submitted Forecast of its expected purchases of the
Product. Such update shall consist of a repetition of
the previously forecasted three (3) Calendar Quarters
along with a newly introduced forecast for the Calendar
Quarter subsequent to the last Calendar Quarter
previously forecasted.
2.3.2 AKORN shall provide sixty (60) days written notice to NOVADAQ
in the event AKORN determines that it cannot fill an order or
meet a forecast. In the event that AKORN is unable to provide
NOVADAQ with its requirement for ICG-C, NOVADAQ may obtain the
required quantity from an alternative source, but subject to
the Termination provisions
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hereof, only until such time as AKORN is able to again provide
the required quantity. The inability of AKORN to supply
amounts or fill orders exceeding the forecast in any quarter
by more than 100% shall not be considered a default or breach
of this Agreement.
2.4 SUBMISSION OF PURCHASE ORDERS. From time to time, NOVADAQ shall
place orders with AKORN, in a format agreed upon by the Parties, for
the purchase of Product, specifying the quantities of the Product
desired and the place(s) to which and the manner and dates by which
delivery is to be made; said delivery dates to be no earlier than
one hundred twenty (120) calendar days after the purchase order
date. All purchase orders shall be sent on forms previously reviewed
by and jointly approved by the Parties and shall be delivered by
NOVADAQ to the following address or as otherwise instructed by
AKORN.
Akorn, Inc.
0000 Xxxxxxxxx Xx.
Xxxxxxx Xxxxx, Xxxxxxxx
Attn: Director of Materials Management
Fax: (000) 000-0000
Purchase orders made in accordance with the provisions of this
Article 2 shall be deemed to be accepted by AKORN if AKORN has not
rejected said purchase orders within ten (10) business days of
receipt of the same. To the extent the terms of any purchase order
or acknowledgment thereof are inconsistent with the terms of this
Agreement, the terms of this Agreement shall prevail.
2.5 DELIVERY. AKORN shall execute all accepted purchase orders
consistent with this Agreement by delivery F.O.B. to NOVADAQ's
designated carrier at AKORN's distribution facility of all ordered
quantities of the Product no later than the delivery dates provided
in NOVADAQ's purchase orders. Title and risk of loss will pass to
NOVADAQ when each order of Product is delivered to NOVADAQ's
designated carrier at AKORN's distribution facility.
2.6 LABELING. Within thirty (30) days after the Effective Date, NOVADAQ,
at its own expense, will provide AKORN with NOVADAQ's labeling for
the Product bearing NOVADAQ's corporate name and trade dress. AKORN,
at NOVADAQ's expense, will print, either directly or through a Third
Party, labels and other printed material to be included as part of
the finished Product. Product manufactured by or for AKORN after
AKORN's receipt of any new or altered labeling for the Product,
shall bear such new labeling, provided, however, that AKORN shall
have no responsibility with respect to the content of such labeling,
provided the content of the labeling printed by AKORN is the same as
the content or specification of the labeling provided by NOVADAQ.
NOVADAQ shall reimburse AKORN for all reasonable costs incurred by
AKORN in making any modifications to the labeling, branding or
imprinting, packaging and/or manufacturing processes to accommodate
NOVADAQ's labeling or to
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accommodate any other changes requested by NOVADAQ. Such
reimbursement shall be made pursuant to invoices submitted by AKORN
to NOVADAQ, which invoices shall be payable within thirty (30) days
after NOVADAQ's receipt thereof.
3. MANUFACTURE OF PRODUCTS
3.1 MANUFACTURE OF PRODUCT; CERTIFICATE OF ANALYSIS. AKORN shall, or
shall cause any Third Party manufacturer contracted by AKORN to
manufacture the Product to, manufacture the Product in compliance
with applicable current good manufacturing practices as described in
21 C.F.R. parts 210 and 211 for ICG-C used in the United States and
any equivalent provisions enforced by applicable Regulatory
Authorities for ICG-C used in countries outside the United States.
All Product supplied by AKORN to NOVADAQ shall materially conform to
the Specifications. AKORN shall perform, or cause to be performed,
release testing of each batch of Product, in a manner consistent
with testing methods agreed upon by the Parties, and AKORN shall
provide to NOVADAQ a Certificate of Analysis with each shipment of
the Product to NOVADAQ or its designated recipient stating that the
Product materially conforms to the Specifications. The Certificate
of Analysis shall be in a format agreed upon by the Parties.
3.2 COMPLIANCE WITH LAWS AND REGULATIONS. While the Product is in its
possession or under its, or its sub-contractor's control, AKORN
shall comply, or ensure that its subcontractors comply, with all
applicable federal, state and local statutory and regulatory
requirements regarding the manufacture, if applicable, packaging,
handling transportation and storage of the Product.
3.3 MANUFACTURING DIFFICULTIES. AKORN shall notify NOVADAQ (within 10
working days) upon any occasion in which AKORN, or any Third Party
with whom AKORN has contracted for the manufacture of the Product,
experiences any manufacturing problems in producing the Product
which AKORN reasonably believes may delay shipment of the Product to
NOVADAQ. Subject to the provisions of Section 12.1, AKORN shall use
Commercially Reasonable Efforts to resolve those problems and shall
keep NOVADAQ fully informed of the status of those efforts. If
delays are reasonably expected to (or do) cause AKORN to be unable
to supply Product in accordance with NOVADAQ'S purchase order, then
NOVADAQ may obtain ICG-C from an alternative source until the supply
problems are resolved by AKORN.
4. PURCHASE PRICE; TERMS OF PAYMENT.
4.1 PRICE. NOVADAQ shall purchase from AKORN and AKORN shall sell to
NOVADAQ Product at a purchase price which shall, at all times,
equals AKORN's best wholesale price for ICG for the calendar month
immediately preceding the date of shipment of a Purchase Order,
adjusted, however, to reflect any volume discounts resulting from
increases in the amount of Product ordered
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by NOVADAQ for the Calendar Year in which such Purchase Order is
received and which are then being offered by AKORN to other Third
Party purchasers of ICG products.
4.2 FREIGHT, INSURANCE AND TAXES. NOVADAQ shall pay all actual freight,
insurance and government sales tax imposed on purchasers for resale,
and duties and other fees (except tax on income to AKORN) incurred
in connection with the sale and shipment of the Product to NOVADAQ.
4.3 PAYMENT. Payments to AKORN for the purchase price of delivered
Product (as well as any other payment due from NOVADAQ to AKORN
under this Agreement) shall be made by NOVADAQ within thirty (30)
days after the date of shipment, except as to Product orders which
are rejected by NOVADAQ in accordance with the procedures contained
in Section 5, or which the Parties dispute constitute Acceptable
Product. In the event Product is rejected by NOVADAQ, but is
determined to be Acceptable Product pursuant to Section 5.2 hereof,
the payment for such Product shall be due and payable within ten
(10) days after the determination with respect to such Product is
made in accordance with Section 5.2 hereof.
4.4 MAINTENANCE OF RECORDS; AUDITS. AKORN shall keep complete records of
its average wholesale cost for ICG product sales and, upon request
of NOVADAQ, shall permit an independent certified public accountant
selected by NOVADAQ, that has first executed an appropriate
confidentiality agreement with AKORN and is reasonably acceptable to
AKORN, to inspect and review AKORN's records during normal business
hours and upon reasonable prior notice, but, in any event, no more
than once per year, in order to verify or determine AKORN's average
wholesale cost of ICG products. The independent certified public
accountant selected by NOVADAQ may not disclose to NOVADAQ specific
sales prices charged to any individual Third Party, but only whether
or not the average wholesale price for ICG products as reported by
AKORN is correct. NOVADAQ shall bear the costs and fees associated
with such inspections and reviews unless it is determined by the
independent certified public accountant that the average wholesale
price was incorrect (in excess of five percent (5%)) in which case
AKORN shall bear the costs and fees of such audit. AKORN shall
promptly refund to NOVADAQ any overpayments made by NOVADAQ because
of such unsupported pricing.
5. INSPECTION OF PRODUCT.
5.1 INSPECTION; REJECTION OF PRODUCT. NOVADAQ shall analyze
representative samples of each lot of Product delivered to NOVADAQ
for purposes of determining whether the same meets the
Specifications ("Acceptable Product") and, if performed, will do so
within sixty (60) days from the date of delivery of the Product to
NOVADAQ's carrier. NOVADAQ shall notify AKORN in writing within said
sixty (60) days of any Product lot, or portion thereof, which
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NOVADAQ is rejecting because NOVADAQ believes such Product is not
Acceptable Product. If NOVADAQ fails to so notify AKORN that it is
rejecting a lot of Product, or portion thereof, within such sixty
(60) day period, such lot of Product, or portion thereof, shall be
deemed to be Acceptable Product. Payment terms will still remain net
thirty days (30). Any Product which is properly rejected in
accordance with the procedures set forth in this Section 5 for which
NOVADAQ has already paid shall be replaced in accordance with
Section 5.3
5.2 THIRD PARTY ANALYSIS. If AKORN, after good faith consultation with
NOVADAQ, disputes any finding by NOVADAQ that Product is not
Acceptable Product, representative samples of the Product shall be
forwarded for analysis to a suitably qualified independent Third
Party jointly selected by AKORN and NOVADAQ, in their reasonable
discretion, which analysis shall be performed in compliance with
applicable FDA regulations for retesting of pharmaceutical products.
The findings of such Third Party regarding whether the Product was
Acceptable Product shall be binding upon the Parties. The cost of
such analysis by such Third Party shall be borne by the Party whose
findings differed from those generated by such Third Party
laboratory.
5.3 REPLACEMENT OF PRODUCT. AKORN shall replace any Product order, or
portion thereof, which is not Acceptable Product (unless such
non-conformance is due to any negligent or wrongful act or omission
by NOVADAQ or its agents or sub contractors), at AKORN's cost and
expense, including shipping costs.
5.4 DISPOSITION OF REJECTED PRODUCT. AKORN shall instruct NOVADAQ as to
the disposition of any Product order or portion thereof determined
not to be Acceptable Product. At the sole option of AKORN, said
Product may be returned to AKORN, at AKORN's expense including
shipping costs, or destroyed in an environmentally acceptable
manner, again at AKORN's expense.
6. INSPECTION AND ACCESS TO FACILITY AND RECORDS.
6.1 INSPECTION BY REGULATORY AUTHORITIES. Upon the request of the FDA or
other Regulatory Authority, such authority shall have access to
observe and inspect AKORN's or its Third Party manufacturers'
facilities and procedures used for the manufacture, testing or
warehousing of the Product and to audit such facilities for
compliance with cGMP and/or other applicable regulatory standards.
6.2 NOTIFICATION OF INQUIRIES. AKORN shall notify NOVADAQ as soon as
possible, and in any event, within ten (10) days, of any written or
oral inquiries, notifications or inspection activity by the FDA or
other Regulatory Authority in regard to or affecting the Product.
AKORN shall furnish to NOVADAQ (i) within ten (10) business days
after receipt, any report or correspondence issued by the FDA or
other Governmental Authority in connection with such visit or
inquiry, including, but not limited to, any FDA Form 483 (List of
Inspectional Observations), Establishment Inspection Report or
applicable portions of any
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FDA Warning Letters which pertain to the Product in the Territory
and (ii) not later than ten (10) business days after to the time it
provides to the FDA or other Regulatory Authority, copies of
proposed responses or explanations relating to items set forth above
(each, a "Proposed Response"), in each case redacted of trade
secrets or other confidential or proprietary information that is
unrelated to the obligations under this Agreement or are unrelated
to the Product. After the filing of a response with the FDA or other
Regulatory Authority, AKORN will notify NOVADAQ of any further
contacts with such agency relating to the subject matter of the
response.
7. WARRANTIES AND INDEMNITIES.
7.1 REPRESENTATIONS AND WARRANTIES OF EACH PARTY. As of the Effective
Date, each of NOVADAQ and AKORN hereby represents, warrants and
covenants to the other Party hereto as follows:
(a) It is a corporation duly organized and validly existing
under the laws of the state, province or other
jurisdiction of its incorporation or formation;
(b) The execution, delivery and performance of this
Agreement by such Party has been duly authorized by all
requisite corporate action and does not require any
shareholder action or approval;
(c) It has the power and authority to execute and deliver
this Agreement and to perform its obligations hereunder;
(d) The execution, delivery and performance by such Party of
this Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with or
result in a breach of any of the terms and provisions of
or constitute a default under (i) a loan agreement,
guaranty, financing agreement, agreement affecting a
product or other agreement or instrument binding or
affecting it or its property; (ii) the provisions of its
charter or operative documents or bylaws; or (iii) any
order, writ, injunction or decree of any court or
governmental authority entered against it or by which
any of its property is bound; and
(e) It shall at all times comply with all applicable
material laws and regulations relating to its activities
under this Agreement.
7.2 SETTLEMENT AND MUTUAL RELEASE. The Parties acknowledge the
Settlement and Mutual Release and confirm and agree that all of the
terms and conditions thereof shall be incorporated in this Agreement
to the extent applicable.
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7.3 PRODUCT WARRANTY. In addition to the representations and warranties
made by AKORN in Section 7.1 hereof, AKORN represents and warrants
to NOVADAQ that all Product supplied hereunder will conform to the
Specifications.
7.4 DISCLAIMER OF ALL OTHER WARRANTIES. EXCEPT FOR THE WARRANTIES
EXPRESSLY MADE BY AKORN IN SECTIONS 7.1 AND 7.3 HEREOF, AKORN MAKES
NO OTHER REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED
(WHETHER WRITTEN OR ORAL), INCLUDING, WITHOUT LIMITATION ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR ANY WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCTS OR AKORN'S
OBLIGATIONS HEREUNDER. IN ADDITION, BECAUSE AKORN WILL HAVE NO
CONTROL OVER (A) ANY OTHER PRODUCT OR PROCEDURE OF WHICH THE PRODUCT
IS A COMPONENT OR IN WHICH THE PRODUCT IS USED, (B) THE CONDITIONS
UNDER WHICH THE PRODUCT OR ANY OTHER PRODUCT OR PROCEDURE OF WHICH
THE PRODUCT IS A COMPONENT OR IS USED, (C) THE DIAGNOSIS OF THE
PATIENTS, OR (D) THE METHODS OF ADMINISTERING OR HANDLING THE
PRODUCT OR ANY OTHER PRODUCT OR PROCEDURE OF WHICH THE PRODUCT IS A
COMPONENT OR IS USED AFTER THE PRODUCT LEAVES AKORN'S POSSESSION,
AKORN DOES NOT WARRANT EITHER A GOOD EFFECT OR AGAINST AN ILL EFFECT
FOLLOWING THE USE OF THE PRODUCT OR ANY OTHER PRODUCT OR PROCEDURE
OF WHICH THE PRODUCT IS A COMPONENT OR IS USED. AKORN EXPRESSLY
DISCLAIMS ANY WARRANTY UNDER SECTION 2-312(3) OF THE UNIFORM
COMMERCIAL CODE.
7.5 INDEMNIFICATION BY AKORN. AKORN shall indemnify, defend and hold
harmless NOVADAQ, its Affiliates and each of its and their
respective officers, directors, shareholders, employees, agents and
representatives (each a "NOVADAQ Indemnified Party") from any
claims, losses, liabilities, costs, expenses (including reasonable
attorney's fees) and damages to Third Parties, including any related
to property or personal injury (each a "Liability"), which any
NOVADAQ Indemnified Party may incur, suffer or be required to pay
resulting from or arising in connection with (a) the breach by AKORN
of any representation or warranty contained in this Agreement; (b)
any violation by AKORN or any Third Party manufacturer of any
applicable federal, state or local regulation, statute or order in
the manufacture, packaging, storage or shipping of Products arising
out of AKORN's duties under this Agreement which is not attributable
to printed materials provided by NOVADAQ; or (c) any negligent act
or omission by AKORN or its Affiliates in carrying out its
obligations under this Agreement. Notwithstanding the foregoing,
AKORN shall have no obligation to defend, indemnify or hold harmless
any NOVADAQ Indemnified Party for any Liability that results from
the negligence or intentional misconduct of NOVADAQ, its Affiliates,
or any of its permitted sub-licensees or any of their respective
officers, directors, employees, agents, consultants or
representatives.
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7.6 INDEMNIFICATION BY NOVADAQ. NOVADAQ shall indemnify, defend and hold
harmless AKORN and its Affiliates and subcontractors, and each of
its and their respective employees, officers, directors and agents
(each an "AKORN Indemnified Party") from and against any Liability
which any AKORN Indemnified Party may incur, suffer or be required
to pay resulting from or arising in connection with (a) the breach
by NOVADAQ of any representation or warranty contained in this
Agreement; (b) materials, including, but not limited to labeling, or
promotional claims supplied or made by NOVADAQ, or (c) the use,
packaging, promotion, distribution, testing, use, marketing, sale or
other disposition of Product by NOVADAQ, its Affiliates, its
permitted sub-licensees or their respective subcontractors.
Notwithstanding the foregoing, NOVADAQ shall have no obligation to
indemnify, defend, or hold harmless any AKORN Indemnified Party for
any Liability that results from the intentional misconduct or
negligence of AKORN, its Affiliates, its permitted subcontractors or
any of their respective employees, officers, directors or agents,
consultants or representatives.
7.7 CONDITIONS TO INDEMNIFICATION. The obligations of the indemnifying
Party under Sections 7.4 and 7.5 are conditioned upon the delivery
of written notice to the indemnifying Party of any potential
Liability promptly after the indemnified Party becomes aware of such
potential Liability. The indemnifying Party shall have the right to
assume the defense of any suit or claim related to the Liability if
it has assumed responsibility for the suit or claim in writing;
provided, however, if in the reasonable judgment of the indemnified
Party, such suit or claim involves an issue or matter which could
have a materially adverse effect on the business operations or
assets of the indemnified Party, the indemnified Party may waive its
rights to indemnity under this Agreement and control the defense or
settlement thereof, but in no event shall any such waiver be
construed as a waiver of any indemnification rights such Party may
have at law or in equity. If the indemnifying Party defends the suit
or claim, the indemnified Party may participate in (but not control)
the defense thereof at its sole cost and expense. Any
indemnification payable to an indemnified Party shall be net of
taxes, insurance or payment received by the indemnified Party from
any Third Party.
7.8 LIMITATION OF LIABILITY. WITH RESPECT TO ANY CLAIM BY ONE PARTY
AGAINST THE OTHER ARISING OUT OF THE PERFORMANCE OR FAILURE OF
PERFORMANCE OF THE OTHER PARTY UNDER THIS AGREEMENT WHERE THE
INABILITY OR FAILURE TO PERFORM IS FOR REASONS BEYOND THE REASONABLE
CONTROL OF SUCH PARTY, THE PARTIES EXPRESSLY AGREE THAT THE
LIABILITY OF SUCH PARTY TO THE OTHER PARTY FOR SUCH BREACH SHALL BE
LIMITED UNDER THIS AGREEMENT OR OTHERWISE AT LAW OR EQUITY TO DIRECT
DAMAGES ONLY AND IN NO EVENT SHALL A PARTY BE LIABLE FOR INCIDENTAL,
PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES OR LOST PROFITS.
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7.9 SETTLEMENTS. Neither Party may settle a claim nor action related to
a Liability without the consent of the other Party, if such
settlement would impose any monetary obligation on the other Party,
constitute or admission by the other Party, expose the other Party
to any additional liability or prosecution, require the other Party
to submit to an injunction or otherwise limit the other Party's
rights under this Agreement. Except as otherwise expressly set forth
in this Article 7, any payment made by a Party to settle any such
claim or action shall be at its own cost and expense.
7.10 INSURANCE. AKORN and NOVADAQ shall obtain and maintain at all times
during the term of this Agreement commercial general liability
insurance, including products liability, with limits which are
commercially reasonable for similarly situated companies and each
agrees to provide the other with a Certificate of Insurance
evidencing this coverage within thirty (30) days of the Effective
Date.
8. RECALLS
8.1 PRODUCT RECALLS. In the event of an actual or threatened recall of
the Product required or recommended by a Governmental Authority of
competent jurisdiction within the Territory or if recall of any
Product is (i) reasonably deemed advisable by AKORN or by NOVADAQ,
or (ii) jointly deemed advisable by AKORN and NOVADAQ, such recall
shall be promptly implemented and administered by NOVADAQ in a
manner which is appropriate and reasonable under the circumstances
and in conformity with accepted trade practices. In the event that a
recall is caused due to the negligent acts or omissions of AKORN,
its Affiliates or subcontractors, or by the fact that the Product
supplied by AKORN to NOVADAQ does not conform to the Specifications,
the cost, including NOVADAQ's reasonable out-of-pocket expenses, of
any such recall shall be borne by AKORN. NOVADAQ shall pay all
costs, including AKORN's reasonable out-of-pocket expenses,
associated with a recall for any other reason, including, without
limitation, recalls (i) caused by actions of Third Parties occurring
after such Product is sold to NOVADAQ, or (ii) due to packaging or
label defects for which NOVADAQ has responsibility, or (iii) due to
any other breach by NOVADAQ of this Agreement.
8.2 NOTICE OF EVENTS THAT MAY LEAD TO PRODUCT RECALL. Each Party shall
keep the other fully and promptly informed of any notification,
event or other information, whether received directly or indirectly,
which might affect the marketability, safety or effectiveness of the
Product or might result in a recall of Product by the HPB, FDA or
other Governmental Body.
8.3 RECALL DUE TO BREACH BY AKORN. In the event of any recall for which
AKORN would be responsible for the costs in accordance with Section
8.1 hereof, AKORN shall, at the election of NOVADAQ either:
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(a) Supply Product, without charge to NOVADAQ, in an amount
sufficient to replace the amounts of Product recalled,
or
(b) Refund to NOVADAQ the amount paid or give credit to
NOVADAQ against outstanding receivables due from NOVADAQ
for the price of Product to be delivered to NOVADAQ in
the future, in amounts equal to the price paid by
NOVADAQ to AKORN for Product so recalled plus the
reasonable transportation costs incurred by NOVADAQ and
not recovered by NOVADAQ in respect of such recalled
Product.
8.4 DEFINITION OF RECALL. For Purposes of the Article 8, "recall" shall
mean any action by NOVADAQ and its Affiliates, or AKORN and its
Affiliates, to recover title or possession or halt distribution,
prescription or consumption of Product sold or shipped to Third
Parties.
8.5 SURVIVAL OF OBLIGATIONS. The provisions and obligations of this
Article 8 shall survive any termination of this Agreement.
9. NON-COMPETITION AND PERMITTED USE
9.1 CONTINUING MANUFACTURE AND SALE OF OTHER ICG PRODUCTS. NOVADAQ
acknowledges that AKORN and its Affiliates have sold and will
continue to sell other products containing ICG prior to and
subsequent to the execution of this Agreement. The Parties agree
that this Agreement shall not be construed to limit the right of
AKORN and its Affiliates to manufacture, have manufactured and sell
other products containing ICG to Third Parties subject to AKORN's
obligations of confidentiality and non-use under this Agreement.
9.2 RESTRICTIVE COVENANTS. Each Party hereby covenants and agrees with
the other that for so long as this Agreement is in effect and for a
period (the "Restricted Period") of five (5) years thereafter,
neither Party shall, without the prior written consent of the other
Party, which consent shall be within the sole and exclusive
discretion of the other Party, either directly or indirectly, on its
own account or as a consultant, agent, partner, joint venturer,
owner, or shareholder of any other person (other than AKORN's status
as a shareholder of NOVADAQ), entity, or in any other capacity, in
any way:
9.2.1 Carry on, be engaged in or have any financial interest in any
business which is in competition with the business of the
other Party. For purposes of this Section 9.2, a business
shall be deemed to be in competition with AKORN if it involves
products which were at the relevant time or at the time of
termination, being marketed in the Territory or which at such
time were under study by AKORN and expected to be marketed in
the Territory within six (6) months of such date for
ophthalmic uses. For purposes of this Section 9.2, a business
shall be deemed to be in competition with
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NOVADAQ if it involves products which were, at the relevant
time or at the time of termination, being marketed in the
Territory by NOVADAQ or which at such time were under study by
NOVADAQ and expected to be marketed in the Territory within
six (6) months of such date of termination, in either case for
any of the Indications only.
9.2.2 Solicit for the business of the other Party (as defined in
paragraph 9.2.1) any then current customer or client of the
other Party or any affiliate of the other Party or, after
termination, anyone who was a customer or client at any time
during the twelve (12) month period immediately preceding
termination.
9.2.3 Solicit, employ or engage any person who is then an employee
of the other Party or any affiliate of the other Party or was
an employee of the other Party or, after termination, any
affiliate of the other Party at any time during the twelve
(12) month period immediately preceding termination.
10. TERM AND TERMINATION.
10.1 TERM. This Agreement shall become effective upon the Effective Date
and, unless earlier terminated as provided below, shall remain in
full force and effect for a period ending on the seventh (7th)
anniversary of the Effective Date (the "Initial Term"). Thereafter,
this Agreement shall automatically renew for successive five (5)
year terms (each a "Renewal Term" and together with the Initial
Term, the "Term") unless, at least 180 days prior to any such
Renewal Term, either Party shall have notified the other of its
intention not to renew this Agreement. Upon expiration or
termination of this Agreement for any reason, all unpaid amounts due
pursuant to this Agreement, including, but not limited to, Section
4.3, shall become immediately due and payable.
10.2 TERMINATION
(a) This Agreement shall terminate upon the mutual written
agreement of the Parties.
(b) If either Party breaches or defaults in the performance
or observance of any of the material provisions of this
Agreement, and such breach or default is not cured
within 60 days after the giving of notice by the
non-defaulting Party specifying such breach or default,
the non-defaulting Party shall have the right to
terminate this Agreement, effective immediately upon
notice to the defaulting Party.
(c) Either Party shall have the right to terminate this
Agreement upon 30 days' notice to the other Party, if
that other Party becomes involved in financial
difficulties as evidenced:
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(i) by that other Party's commencement of a voluntary
case under any applicable bankruptcy code or
statue, or by its authorizing, by appropriate
proceedings, the commencement of such voluntary
case; or
(ii) by its failing to receive dismissal of any
involuntary case under any applicable bankruptcy
code or statute within 90 days after initiation of
such action or petition; or
(iii) by its seeking relief as a debtor under any
applicable law of any jurisdiction relating to the
liquidation or reorganization of debtors or to the
modification or alteration of the rights of
creditors, or by consenting to or acquiescing in
such relief; or
(iv) by the entry of an order by a court of competent
jurisdiction finding it to be bankrupt or
insolvent, or ordering or approving its
liquidation, reorganization or any modification or
alteration of the rights of its creditors or
assuming custody of, or appointing a receiver or
other custodian for, all or a substantial part of
its property or assets; or
(v) by its making an assignment for the benefit of, or
entering into an agreement with, its creditors, or
appointing or consenting to the appointment of a
receiver or other custodian for all or a
substantial part of its property or by the
appointment of such a receiver by a Third Party,
which appointment is not revoked by a Court of
competent jurisdiction within sixty (60) days of
its occurrence.
(d) The failure by a Party to exercise its right to
terminate this Agreement pursuant to Section 9.2. in the
event of any occurrence giving rise thereto shall not
constitute waiver of the right in the event of any
subsequent occurrence.
10.3 EFFECT OF TERMINATION.
(a) Unless otherwise agreed to between the Parties, all
Product on hand as of the effective date of expiration
or termination of this Agreement will be treated as
follows as soon as practicable:
(i) Product manufactured and packaged pursuant to
purchase orders previously received from NOVADAQ,
will be delivered by AKORN to NOVADAQ, whereupon
15
NOVADAQ will pay AKORN therefore in accordance
with the terms hereof; and
(ii) Work in progress commenced by AKORN in accordance
with a Binding Quarterly Forecast will, at the
option of NOVADAQ (but at the option of AKORN in
the case of termination hereof by AKORN under
Section 10.2(b)), (A) cease, and such work in
progress will remain with AKORN (in which case
NOVADAQ will pay AKORN an amount equal to AKORN's
actual costs incurred in connection with the
performance and cessation of such work less the
cost to AKORN of materials that can be returned by
AKORN or used by AKORN in later batches of other
products manufactured by AKORN as reasonably
determined by AKORN) or (B) be completed by AKORN
and delivered to NOVADAQ whereupon NOVADAQ will
pay AKORN therefore in accordance with the terms
hereof.
(b) In the event that NOVADAQ terminates this Agreement
either pursuant to Section 10.2.(b) because of a
Material Breach, or pursuant to 10.2.(c), then, in
either event, NOVADAQ shall thereafter be permitted to
order all further supply of Product directly from any
Third Party which is at the time of termination a
Permitted Manufacturer or other qualified supplier.
AKORN will license to NOVADAQ, within 60 (sixty) days of
the date of this Agreement, for the Indications, all
required Know-How necessary to manufacture the Product
which license shall become effective only in the event
that NOVADAQ terminates this Agreement either pursuant
to Section 10.2(b) because of a Material Breach or
pursuant to 10.2(c).
10.4 ACCRUED OBLIGATIONS. Termination of this Agreement for any cause
shall not release either Party from any obligation or liability
incurred prior to or upon termination hereof or which subsequently
arises under Section 10.6.
10.5 NO WAIVER. The failure on the part of either Party to exercise or
enforce any right conferred upon it hereunder shall not be deemed to
be a waiver of any such right nor operate to bar the exercise or
enforcement thereof at any time thereafter.
10.6 SURVIVAL. Subject to Section 10.3 hereof, the following provisions
shall survive expiration or termination of this Agreement: Sections
4.4, 5.3, 5.4, 9.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, and 12.9 and
Articles 7, 8 and 11.
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11. CONFIDENTIALITY.
11.1 NONDISCLOSURE OBLIGATION. Each of NOVADAQ and AKORN agree to use any
information received by it from the other Party (the "Information")
only in accordance with this Agreement and not to disclose
Information to any Third Party, without the prior written consent of
the other Party, for a period of five (5) years from the termination
or expiration of this Agreement. These obligations shall not apply
to Information that:
(a) Is known by the receiving Party at the time of its
receipt, and not through a prior disclosure by the
disclosing Party, as documented by the receiving Party's
business records;
(b) Is at the time of disclosure or thereafter becomes
published or otherwise part of the public domain without
breach of this Agreement by the receiving Party;
(c) Is subsequently disclosed to the receiving Party by a
Third Party who has the right to make such disclosure;
(d) Is developed by the receiving Party independently of the
Information received from the disclosing Party and such
independent development can be documented by the
receiving Party; or
(e) Is required by law, regulation, rule, act or order of
any governmental authority or agency to be disclosed by
a Party, provided that notice is promptly delivered to
the other Party in order to provide an opportunity to
seek a protective order or other similar order with
respect to such Information and thereafter the
disclosing Party discloses to the requesting entity only
the minimum Information required to be disclosed in
order to comply with the request, whether or not a
protective order or other similar order is obtained by
the other Party.
11.2 PERMITTED DISCLOSURES. Information may be disclosed to employees,
agents, consultants, sub-licensees or suppliers or Third Party
manufacturers of the recipient Party or its Affiliates, but only to
the extent required to accomplish the purposes of this Agreement and
only if the recipient Party obtains prior agreement from its
employees, agents, consultants, sub-licensees, suppliers or Third
Party manufacturers to whom disclosure is to be made to hold in
confidence and not make use of such Information for any purpose
other than those permitted by this Agreement. Each Party will use at
least the same standard of care as it uses to protect proprietary or
confidential information of its own to ensure that such employees,
agents, consultants, sub-licensees, suppliers or Third Party
manufacturers do not disclose or make any unauthorized use of the
Information.
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11.3 DISCLOSURE OF AGREEMENT. Neither NOVADAQ nor AKORN shall release to
any Third Party or publish in any way any non-public information
with respect to the terms of this Agreement or concerning their
cooperation without the prior written consent of the other, which
consent will not be unreasonably withheld or delayed, provided,
however, that either Party may disclose the terms of this Agreement
to the extent required to comply with applicable laws, including,
without limitation the rules and regulations promulgated by the
United States Securities and Exchange Commission, provided, however,
that prior to making any such disclosure, the Party intending to so
disclose the terms of this Agreement shall (i) provide the
non-disclosing Party with written notice of the proposed disclosure
and a opportunity to review and comment on the intended disclosure
which is reasonable under the circumstances and (ii) shall seek
confidential treatment for as much of the disclosure as is
reasonable under the circumstances, including, without limitation,
seeking confidential treatment of any information as may be
requested by the other Party. Notwithstanding any other provision of
this Agreement, each Party may disclose the terms of this Agreement
to lenders, investment bankers and other financial institutions of
its choice solely for purposes of financing the business operations
of such Party, if the disclosing Party uses reasonable efforts to
obtain a signed confidentiality agreement with such financial
institution with respect to such information on terms substantially
similar to those contained in this Article 11.
11.4 PUBLICITY. Subject to Section 11.3, all publicity, press releases
and other announcements relating to this Agreement or the
transactions contemplated hereby shall be reviewed in advance by,
and shall be subject to the approval of, both Parties. The Party
responding to a request for such approval shall respond to the other
Party in writing within five (5) days of such request.
12. MISCELLANEOUS.
12.1 FORCE MAJEURE. Except for the obligation to make payment when due,
each Party shall be excused from liability for the failure or delay
in performance of any obligation under this Agreement by reason of
any event beyond such Party's reasonable control including but not
limited to Acts of God, fire, flood, explosion, earthquake, or other
natural forces, war, civil unrest, accident, destruction or other
casualty, any act, inaction or delay of any government or government
agency, or any other event similar to those enumerated above. Such
excuse from liability shall be effective only to the extent and
duration of the event(s) causing the failure or delay in performance
and provided that the Party has not caused such event(s) to occur.
Notice of a Party's failure or delay in performance due to force
majeure must be given to the other party within Ten (10) days after
its occurrence. All delivery dates in this Agreement that have been
affected by force majeure shall be suspended for the duration of
such force majeure.
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12.2 ASSIGNMENT
(a) ASSIGNMENT BY NOVADAQ. NOVADAQ may assign any or all of
its rights or obligations under this Agreement in the
Territory to any of its Affiliates, for so long as they
remain Affiliates. In addition, NOVADAQ may assign any
or all of its rights or obligations under this Agreement
in the Territory in conjunction with a merger or
acquisition of NOVADAQ. NOVADAQ may not otherwise assign
any of its rights or obligations under this Agreement
without AKORN's prior written consent, which consent
shall not be unreasonably withheld. AKORN shall respond
to such requests by NOVADAQ for assignment within thirty
(30) days from such request. Any permitted assignment
shall not relieve NOVADAQ of its responsibilities for
performance of its obligations under this Agreement.
(b) ASSIGNMENT BY AKORN. AKORN may assign any or all of its
rights or obligations under this Agreement to any of its
Affiliates. AKORN may also assign any or all of its
rights or obligations under this Agreement in
conjunction with a merger or acquisition of AKORN. In
addition, AKORN may assign all or part of its
obligations to a Third Party manufacturer after
receiving NOVADAQ's prior written consent, (other than
to a Permitted Manufacturer for which consent shall not
be required) which consent shall not be unreasonably
withheld or delayed. Any permitted assignment shall not
relieve AKORN of its responsibilities for performance of
its obligations under this Agreement.
(c) BINDING NATURE OF ASSIGNMENT. This Agreement shall be
binding upon and inure to the benefit of the successors
and permitted assigns of the Parties. Any assignment not
in accordance with this Section 12.2 shall be void.
12.3 NO WAIVER. The failure of either Party to require performance by the
other Party of any of that other Party's obligations hereunder shall
in no manner affect the right of such Party to enforce the same at a
later time. No waiver by any Party hereto of any condition, or of
the breach of any provision, term, representation or warranty
contained in this Agreement, whether by conduct or otherwise, in any
one or more instances, shall be deemed to be or construed as a
further or continuing waiver of any such condition or breach, or of
any other condition or of the breach of any other provision, term,
representation or warranty hereof.
12.4 SEVERABILITY. If a court or other tribunal of competent jurisdiction
should hold any term or provision of this Agreement to be excessive,
or invalid, void or unenforceable, the offending term or provision
shall be deleted or revised to the
19
extent necessary to be enforceable, and, if possible, replaced by a
term or provision which, so far as practicable achieves the
legitimate aims of the Parties.
12.5 RELATIONSHIP BETWEEN THE PARTIES. Both Parties are independent
contractors under this Agreement. Nothing herein contained shall be
deemed to create an employment, agency, joint venture or partnership
relationship between the Parties hereto or any of their agents or
employees, or any other legal arrangement that would impose
liability upon one Party for the act or failure to act of the other
Party. Neither Party shall have any express or implied power to
enter into any contracts or commitments or to incur any liabilities
in the name of, or on behalf of, the other Party, or to bind the
other Party in any respect whatsoever.
12.6 CORRESPONDENCE AND NOTICES.
(a) Ordinary Notices. Correspondence, reports,
documentation, and any other communication in writing
between the Parties in the course of ordinary
implementation of this Agreement shall be delivered by
hand, sent by facsimile, overnight courier or by airmail
to the employee or representative of the other Party who
is designated by such other Party to receive such
written communication.
(b) Extraordinary Notices. Extraordinary notices and
communications (including, without limitation, notices
of termination, force majeure, material breach, change
of address) shall be in writing and sent by prepaid
registered or certified mail, overnight courier or by
facsimile confirmed by prepaid registered or certified
mail letter, and shall be deemed to have been properly
served to the addressee three days after mailing by
registered or certified mail, the next day if sent by
overnight courier and upon receipt if sent by facsimile.
(c) Addresses. In the case of NOVADAQ, the proper address
for communications and for all payments shall be:
Novadaq Technologies, Inc.
000 Xxx Xxxx Xxxx, Xxxxx 000
Xxxxxxx, Xxxxxxx X0X 0X0
Attn: Chief Financial Officer
Fax: (000) 000-0000
and in the case of AKORN, the proper address for communications and
for all payments shall be:
Akorn, Inc.
0000 Xxxxxxxxx Xxxxx
Xxxxxxx Xxxxx, Xxxxxxxx 00000
Attn: Chief Financial Officer
Fax: (000) 000-0000
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12.7 CHOICE OF LAW. This Agreement is subject to and governed by the laws
of the State of Illinois, excluding its conflict of laws provisions.
12.8 ENTIRE AGREEMENT; AMENDMENT. This Agreement sets forth the complete,
final and exclusive agreement between the Parties with respect to
the subject matter hereto and supersedes and terminates all prior
and contemporaneous agreements and understandings between the
Parties, whether oral or in writing. No subsequent alteration,
amendment, change, waiver or addition to this Agreement shall be
binding upon the Parties unless reduced to writing and signed by an
authorized officer of each Party. No understanding, agreement,
representation or promise, not explicitly set forth herein, other
than the Settlement and Mutual Release executed by the Parties on
the date hereof, has been relied on by either Party in deciding to
execute this Agreement as set forth herein.
12.9 ARBITRATION. The Parties shall attempt in good faith to promptly
resolve any controversy, claim or dispute arising between them. In
the event that the Parties are unable to resolve any such
controversy, claim or dispute within 30 days, then any such
controversy, claim or dispute between the Parties, directly or
indirectly, concerning this Agreement or the breach hereof, or the
subject matter hereof, shall be finally settled by binding
arbitration in accordance with the Rules of Conciliation and
Arbitration of the International Chamber of Commerce. Prior to
initiating such arbitration proceedings the Parties shall attempt to
resolve the dispute by good faith negotiations between themselves.
The situs of the arbitration proceedings shall be the City of
Xxxxxxx, Xxxxxxx, Xxxxxx, if the arbitration was requested or
initiated by NOVADAQ, and in the City of Chicago, Illinois, U.S.A.,
if the arbitration was requested or initiated by Akorn, and judgment
upon the award rendered may be entered in any court having a
jurisdiction hereof. In deciding the dispute the arbitrator(s) shall
apply first the plain meaning of this Agreement, but in matters not
fairly provided for in this Agreement, shall apply the substantive
law of the State of Illinois. All pleadings, evidence, testimony, or
other submissions to the arbitrator(s) shall be in the English
language as shall be the judgment of the arbitrator(s). Pending
resolution of any such arbitration, any Party may deposit with its
solicitors or another mutually agreeable party an amount equal to
50% of any monetary amount in dispute or such other amount as may be
directed by the arbitrator(s) upon preliminary application.
12.10 HEADINGS. The headings and captions used in this Agreement are
solely for the convenience of reference and shall not affect its
interpretation.
12.11 COUNTERPARTS. This Agreement may be executed in one or more
counterparts each of which shall be an original and all of which
shall constitute together the same document.
12.12 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all other acts, as may
be necessary or appropriate in
21
order to carry out the purposes and intent of this Agreement
including, without limitation, any filings with any antitrust agency
which may be required.
IN WITNESS WHEREOF, this Agreement has been executed by the duly
authorized representatives of the Parties as of the date set forth below.
AKORN, INC. NOVADAQ TECHNOLOGIES, INC.
By:______________________________ By:______________________________
Name:____________________________ Name:____________________________
Title:___________________________ Title:___________________________
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SCHEDULE A
SPECIFICATIONS
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