Exhibit 10.13
EXCLUSIVE DISTRIBUTION AND SUPPLY AGREEMENT
This Exclusive Distribution and Supply Agreement (the "Agreement") is
made as of this 13th day of December, 2000 (the "Effective Date"), by and
between Xxxxxx-Xxxxx Laboratories, Inc., a corporation organized under the laws
of the State of Minnesota with a place of business at 00000 00xx Xxxxxx Xxxxx,
Xxxxxxxxxxx, Xxxxxxxxx 00000 (hereinafter referred to as "Xxxxxx-Xxxxx") and
Eon Labs Manufacturing, Inc., a corporation organized under the laws of the
State of Delaware, with a place of business at 000-00 Xxxxx Xxxxxxx Xxxxxx,
Xxxxxxxxx, Xxx Xxxx 00000 (hereinafter referred to as "Eon").
BACKGROUND. Eon has secured and obtained regulatory approval from the
FDA (as defined below) for the Product (as defined below). Eon desires to grant
to Xxxxxx-Xxxxx exclusive rights to distribute the Product in the Territory (as
defined below) and to supply (directly or through a contract manufacturer) to
Xxxxxx-Xxxxx its requirements for the Product in the Territory. Xxxxxx-Xxxxx
desires to obtain the rights and a secure supply of the Product which
Xxxxxx-Xxxxx will market, sell and distribute in the Territory by Xxxxxx-Xxxxx,
on an exclusive basis, under Xxxxxx-Xxxxx'x private label, bearing
Xxxxxx-Xxxxx'x logo and trademark and NDC number identified on Appendix 2.1. In
consideration of the mutual covenants hereinafter expressed, the parties agree
as follows:
1. DEFINITIONS. Capitalized terms appearing in this Agreement
(including the appendices to this Agreement) without definition shall have the
meaning given them in Appendix 1 attached hereto.
2. DISTRIBUTION RIGHTS, PRODUCT MANUFACTURE AND SUPPLY.
2.1 EXCLUSIVE GRANT. Subject to the provisions of Section 6.2.1, Eon
grants to Xxxxxx-Xxxxx the exclusive right to distribute (including the right to
appoint subdistributors and sales agents) and sell the Product in the
Territory. Xxxxxx-Xxxxx shall sell and distribute the Product in the Territory
under Xxxxxx-Xxxxx'x private label, bearing Xxxxxx-Xxxxx'x logo and trademark
identified on Appendix 2.1. Subject to the provisions of Section 6.2.1, during
the Term or any Renewal Term of this Agreement, Eon shall not, directly or
indirectly, sell the product in the territory, or authorize or permit any other
party to sell or distribute 400 mg amiodarone in the territory manufactured
under Eon's ANDA.
2.2 MANUFACTURE AND PURCHASE. Eon agrees to manufacture (or have
manufactured) and supply the Products for sale and distribution in the Territory
under Xxxxxx-Xxxxx'x private label, bearing Xxxxxx-Xxxxx'x logo and trademark
identified on Appendix 2.1, and Xxxxxx-Xxxxx agrees to purchase from Eon its
entire requirements for the Products during the Term or any Renewal Term of this
Agreement.
2.3 EON'S AUTHORITY TO GRANT RIGHTS. Eon represents and warrants that
it has the right, title and authority to grant to Xxxxxx-Xxxxx the rights
granted, and to undertake the commitments made, by Eon under this Agreement.
The commitments and obligations of Eon
under this Agreement do not violate any other agreement to which Eon is a party
or any rights granted by Eon to any third party. Eon will not provide any
consulting, research, analytical or developmental services to any third party
with respect to any aspect of any amiodarone product which may compete with the
Product.
3. TERM.
3.1 TERM. This Agreement will commence on the Effective Date set forth
in the first paragraph of this Agreement and will continue until the expiration
of the fifth (5th) Market Year, unless sooner terminated pursuant to the terms
of this Agreement (the "Term").
3.2 RENEWAL. The term of this Agreement will automatically renew for
successive renewal terms of three (3) Market Years each (each, a "Renewal
Term"), unless written notice of non-renewal is given by either party to the
other at least one year prior to expiration of the then current term;
PROVIDED, HOWEVER, without the prior written consent of Xxxxxx-Xxxxx, Eon may
not give written notice of non-renewal to Xxxxxx-Xxxxx unless Xxxxxx-Xxxxx is
then in material breach of this Agreement.
4. MANUFACTURING PROCEDURES.
4.1 CONTRACT MANUFACTURE. The parties acknowledge and agree that
manufacture of the Product may be undertaken on behalf of Eon by a contract
manufacturer (the "Contract Manufacturer"). Any Contract Manufacturer secured
by Eon will operate under a contract manufacture agreement (the "Contract
Manufacture Agreement"). Any Contract Manufacture Agreement shall give
Xxxxxx-Xxxxx all rights with respect to the manufacture of Product, SOPs and
facility of the Contract Manufacturer (including the right of inspection) as
Xxxxxx-Xxxxx is granted under this Agreement with respect to Eon.
4.2 MANUFACTURING PROCEDURES. Eon warrants that Eon (or any Contract
Manufacturer) has the requisite experience, knowledge and expertise, suitable
facility and qualified personnel, as well as the legal right, to perform its
obligations under this Agreement in a sound, safe, lawful and workmanlike
manner. In addition, Eon (or any Contract Manufacturer) will conform with the
terms of Appendix 4 attached hereto.
5. FORECASTS AND PURCHASE ORDERS.
5.1 FORECASTS Xxxxxx-Xxxxx will deliver to Eon, prior to the first
month of each Market Year, its Forecast for each Product for that Market Year.
This Forecast will be updated quarterly on a rolling 12-month basis. Eon will
use the Forecast for planning purposes only.
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5.2 PURCHASE ORDERS.
5.2.1 Products will be ordered by Xxxxxx-Xxxxx by the issuance of
separate, pre-numbered purchase orders. Eon will supply Xxxxxx-Xxxxx with its
estimated batch yield of Product to assist Xxxxxx-Xxxxx in ordering batch lot
quantities.
5.2.2 Xxxxxx-Xxxxx'x purchase orders will designate the desired
quantities of the particular Product, delivery dates and destinations and will
be submitted at least ninety (90) days prior to the shipment date specified. Eon
will fill and ship all orders of Products in accordance with Xxxxxx-Xxxxx'x
purchase orders provided that if such orders exceed the Forecast for such period
by more than twenty percent (20%), Eon shall not be required to fill
and ship such excess amount, but shall use commercially reasonable efforts to
do so. If any Xxxxxx-Xxxxx purchase order is not submitted at least ninety (90)
days prior to the requested delivery dates, Eon will still use commercially
reasonable efforts to meet Xxxxxx-Xxxxx'x requested delivery dates. Eon may not
produce Product more than sixty (60) days prior to the requested delivery
date.
5.2.3 All sales of Products by Eon to Xxxxxx-Xxxxx will be subject to
the provisions of this Agreement and will not be subject to the terms and
conditions contained in any purchase order of Xxxxxx-Xxxxx or confirmation of
Eon, except insofar as any such purchase order or confirmation establishes (a)
the quantity by Products to be sold, (b) the shipment dates for those Products,
and (c) the destinations to which those Products are to be shipped.
6. MILESTONE PAYMENTS, PRODUCT PURCHASE PRICE, ROYALTY PAYMENTS.
6.1 MILESTONE PAYMENTS. As consideration and reimbursement to Eon for
certain of its expenses in developing, testing and securing regulatory approval
for the commercial sale of the Product in the Territory, Xxxxxx-Xxxxx will pay
to Eon the following milestone payments:
(a) Within thirty (30) days following execution of this Agreement by
the parties, five hundred thousand dollars ($500,000);
(b) Within thirty (30) days following the First Commercialization
Date, two hundred fifty thousand dollars ($250,000); and
(c) Within thirty days following the first anniversary of the
Effective Date, an additional two hundred fifty thousand dollars ($250,000).
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6.2 ROYALTIES AND PAYMENT.
6.2.1 EARNED ROYALTY. From the First Commercialization Date,
Xxxxxx-Xxxxx will pay to Eon an Earned Royalty equal to the applicable Royalty
Percentage on Net Sales. Notwithstanding anything contained in this Agreement to
the contrary, in the event a third party is selling an amiodarone 400 mg product
in the Territory, the Royalty Percentage on which the Earned Royalty is computed
will thereafter be reduced to nine percent (9%). In addition, in such event,
Eon shall have the right to manufacture, distribute and market a generic form of
the Product in the Territory, in exchange for its agreement to pay to
Xxxxxx-Xxxxx an earned royalty of nine percent (9%) on its Net Sales in
the Territory (as such terms shall be similarly defined as in this Agreement)
during the Term or Renewal Term of this Agreement.
6.2.2 MINIMUM ROYALTY.
(a) Xxxxxx-Xxxxx shall pay to Eon each Market Year (or portion thereof)
during the Term and each Renewal Term a minimum royalty as follows (the "Minimum
Royalty"):
MARKET YEAR MINIMUM ROYALTY
----------- ---------------
1 $2,750,000
2 $3,500,000
3 $4,000,000
4 $4,000,000
5 and each Market $4,000,000
Year during any Renewal Term
If the Earned Royalty for such Market Year is less than the applicable Minimum
Royalty, then 90 days after the end of the last quarter of such Market Year,
Xxxxxx-Xxxxx shall pay to Eon the amount of the shortfall between the Minimum
Royalty and the Earned Royalty for such Market Year (the "Shortfall").
Notwithstanding anything contained in this Agreement to the contrary, in the
event a third party is selling an amiodarone 400 mg product in the Territory,
upon written notice given by Xxxxxx-Xxxxx to Eon, detailing the basis of
Xxxxxx-Xxxxx'x understanding of such third party sales, this Section 6.2.2 shall
become null and void (except as to Minimum Royalties accrued until the date of
such notice which Xxxxxx-Xxxxx shall still be obligated to pay, on a prorated
basis) and there shall thereafter be no Minimum Royalties.
(b) If there has been a Shortfall in any Market Year, then Xxxxxx-Xxxxx
may give written notice at any time after the end of the second Market Year of
its desire to renegotiate in good faith the Minimum Royalties for subsequent
Market Years commencing with the third Market Year. Upon such notice from
Xxxxxx-Xxxxx, Eon shall (within 30 days) give Xxxxxx-Xxxxx written notice
indicating either that it is willing to renegotiate the Minimum Royalties, or
that it does not wish to do so.
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(i) If Eon does not give timely written notice that Eon wishes to
renegotiate, Xxxxxx-Xxxxx may at any time after expiration of the 30-day notice
period, give Eon written notice of termination which will be effective 120 days
following the date of the notice of termination.
(ii) If Eon gives timely written notice that it is willing to
renegotiate, Xxxxxx-Xxxxx and Eon shall enter into good faith negotiations for a
period of ninety (90) days (commencing with the date of Eon's written notice).
If they are unable to reach agreement to adjust the Minimum Royalties during
that time period, then Xxxxxx-Xxxxx may at any time within ninety (90) days
after expiration of the 90-day negotiation period give Eon written notice of
termination which will be effective 120 days following the date of the notice of
termination.
(iii) It is understood that in the event of termination pursuant to
this Section 6.2.2(b), Xxxxxx-Xxxxx and Eon shall honor all purchase orders
placed prior to the date of termination.
6.2.3 PAYMENT AND REPORTING OF EARNED ROYALTIES. Earned Royalties will
be paid quarterly within 60 days after the end of each Market Year quarter
during the period for which any Earned Royalties may be due, and will be
accompanied by a written summary listing the Net Sales of Xxxxxx-Xxxxx during
that Market Year quarter on which Earned Royalties are due.
6.2.4 RECORDS AND INSPECTIONS. Xxxxxx-Xxxxx will maintain accurate
records containing sufficient data from which Earned Royalties due Eon under
this Agreement may be calculated. Xxxxxx-Xxxxx will maintain those records for
two (2) years after the end of the Market Year to which those records relate.
Xxxxxx-Xxxxx will, upon reasonable notice from Eon, permit examination of those
records by an independent firm of accountants selected by Eon and reasonably
acceptable to Xxxxxx-Xxxxx. The fees and expenses of such independent
accountants shall be paid by Eon, unless (a) the audit of any Market Year that
is closed evidences an underpayment of Earned Royalties for the closed Market
Year by more than five percent (5%), and (b) either Xxxxxx-Xxxxx does not
dispute such underpayment, or if Xxxxxx-Xxxxx disputes such underpayment,
the dispute is finally resolved (in accordance with the terms of this Agreement)
either by agreement of the parties or by a final and binding arbitration
decision under Section 15.6.2 confirming such underpayment. Eon may not conduct
more than one such audit during any Market Year, and any such audit may not
cover a period of more than two Market Years (in addition to any closed quarters
of the Market Year in which the audit is conducted). All records disclosed to
those accountants will be deemed to be confidential information of Xxxxxx-Xxxxx
subject to obligations of confidentiality and non-disclosure under this
Agreement. Eon's accountants may not disclose to Eon any information relating to
the business of Xxxxxx-Xxxxx, except as should properly be contained in any
Summary to Eon under Section 6.2.3 or to enable Eon to enforce its rights to
royalty payments or other payments due under this Section 6.
6.3 PRODUCT PURCHASE PRICE AND PAYMENT. Eon shall sell product to
Xxxxxx-Xxxxx at the prices and on the terms listed in Appendix 6.3 attached
hereto (the "Purchase Price"), packaged, labeled and delivered f.o.b. point of
shipment (Eon's loading dock). The
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parties acknowledge that, as shown on Appendix 6.3, the Purchase Price to be
paid to Eon will reflect the quantity of Products which are purchased by
Xxxxxx-Xxxxx during each Market Year. Payment of the Purchase Price for all
deliveries of conforming product and services will be made in U.S. dollars, in
full within thirty (30) days after Xxxxxx-Xxxxx'x receipt of the Product. If
payment is not received in accordance with this Section 6.3, Eon shall not be
obligated to deliver any further Product to Xxxxxx-Xxxxx until such payment has
been made.
7. SHIPMENT AND RISK OF LOSS. Eon will ship all Products to
Xxxxxx-Xxxxx, f.o.b. point of shipment (Eon's loading dock). The risk of loss of
or damage to any Product ordered by Xxxxxx-Xxxxx and shipped by Eon will pass
to Xxxxxx-Xxxxx upon Eon's tender of delivery to the carrier f.o.b. point of
shipment. Xxxxxx-Xxxxx will pay the cost of all freight and insurance for each
shipment.
8. OBLIGATIONS OF XXXXXX-XXXXX.
8.1. Conduct of Business. Xxxxxx-Xxxxx covenants and agrees with Eon
that:
8.1.1 It will use its commercially reasonable efforts to promote the
sale and distribution of the Product in the Territory in a manner consistent
with that employed by Xxxxxx-Xxxxx in the promotion of other products of
similar character, and shall use commercially reasonable efforts to facilitate
the initiation of the sale of the Product in the Territory.
8.1.2 It will (a) not conduct its business related to the sale and
promotion of the Product in a manner that knowingly, intentionally, willfully
and unfairly reflects unfavorably on the Product and the good name, goodwill and
reputation of Eon; (b) not make any misrepresentations with regard to Eon or the
Product; (c) not publish or employ or cooperate in the publication or employment
of any advertising material that misrepresents the Product; (d) not make
representations or warranties to customers or potential customers with respect
to the specifications, features or capabilities of the Product that are
inconsistent with the warranty set forth in Section 9.1 below.
8.1.3 It will comply with all applicable local, state or federal rules,
regulations, statutes and laws in promoting, marketing, storing, distributing
and selling the Product.
8.1.4 It will refrain from distributing and selling the Product outside
the Territory, unless previously authorized in writing by Eon on a case by case
basis.
8.1.5 It will promptly notify Eon of any adverse or unexpected reaction
or results or any charges, complaints or claims by customers or other persons
or any actual or potential government action relevant to the Product and the
parties will discuss with each other measures to be undertaken necessary to
resolve the problem. (Similarly, Eon agrees that it will promptly notify
Xxxxxx-Xxxxx of any adverse or unexpected reaction or results or any charges,
complaints or claims by customers or other persons or any actual or potential
government action relevant to the Product and the parties will discuss with each
other measures to be undertaken
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necessary to resolve the problem.)
8.1.6 Xxxxxx-Xxxxx agrees that it will maintain an active sales
organization (either directly or through an outside network of distributors,
sales agents and representatives, or both) with personnel capable of competently
dealing with the marketing of the Product throughout the territory.
8.2. NON-COMPETITION. During the Term and any Renewal Term and in any
case for a period of not less than five (5) years from the date of this
Agreement, neither party shall directly or indirectly develop, license,
manufacture, distribute, promote, offer or sell in the Territory any amiodarone
400 mg. tablets, capsules or product other than the Product (as contemplated
by this Agreement), without the other party's prior written consent, which may
be withheld for any reason in such party's sole discretion; PROVIDED,
HOWEVER, (a) in the event a party terminates this Agreement during the Term
pursuant to Section 14.1 (a) or (b), this Section 8.2 shall expire immediately
upon such termination as to the party giving notice (but not as to the
bankrupt, insolvent or breaching party) and (B) in the event Xxxxxx-Xxxxx
terminates the Agreement during the Term in accordance with Section 14.1(c),
this section 8.2 shall expire immediately upon such termination as to Eon (but
not as to Xxxxxx-Xxxxx).
9. PRODUCT WARRANTIES.
9.1 PRODUCT WARRANTIES. Eon warrants that all products sold by Eon
to Xxxxxx-Xxxxx pursuant to this Agreement will conform and perform in
accordance with the Specifications, will not be defective in materials or
workmanship at the time of manufacture and shipment, and will have been
manufactured, Labeled, Packaged, tested and shipped in compliance with the
applicable ANDA, CGMP and the Act. Without limitation, Eon warrants that the
Products delivered by Eon to Xxxxxx-Xxxxx shall be manufactured in an FDA
Registered Facility under CGMP, and (a) as of the date of shipment are not
adulterated or misbranded (within the meaning of the Act), and are not an
article which may not, under the provisions of Section 404, 505 or 513 of the
Act, be introduced in interstate commerce; and (b) at the time of delivery
shall be in good, usable and merchantable condition. THIS WARRANTY IS
EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, COVENANTS AND CONDITIONS
WHETHER WRITTEN, ORAL, EXPRESS OR IMPLIED BY STATUTE OR OTHERWISE (INCLUDING
WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE) AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART
OF EON. IN NO EVENT SHALL EON BE LIABLE TO XXXXXX-XXXXX FOR ANY SPECIAL,
INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING OUT OF ANY WARRANTY
CLAIM OR DEFECTIVE PRODUCT CLAIM, OTHER THAN IN CONNECTION WITH A THIRD PARTY
CLAIM FOR PERSONAL INJURY OR PROPERTY DAMAGE. AS WELL, IN NO EVENT SHALL
XXXXXX-XXXXX BE LIABLE TO EON FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR
INDIRECT DAMAGES ARISING OUT OF ANY WARRANTY CLAIM OR DEFECTIVE PRODUCT
CLAIM, OTHER THAN IN CONNECTION WITH A THIRD PARTY CLAIM FOR PERSONAL INJURY
OR PROPERTY DAMAGE.
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9.2 REGULATORY APPROVAL FOR THE PRODUCT.
9.2.1 Eon will maintain regulatory approval for the product in
accordance with the ANDA.
9.2.2 Eon represents and warrants that it has not received any
notification of, and has no knowledge that there is now pending or that there
have been any FDA regulatory orders to restrict or limit the use of the
Product. Eon has no knowledge of any adverse test results regarding the Product
that would render the Product, or application thereof (now existing or
anticipated) unsuitable or unsafe.
9.3 Expired Product.
9.3.1 Xxxxxx-Xxxxx shall be responsible for maintaining and managing
its inventory of Product, and no expired Product delivered by Eon in accordance
with this Agreement shall be returnable to Eon, except with Eon's prior written
approval.
9.3.2 All Product in Xxxxxx-Xxxxx'x possession that has expired shall
be destroyed by Xxxxxx-Xxxxx, at Xxxxxx-Xxxxx'x expense.
10. PRODUCT RECALLS. In the event (i) the FDA issues a request,
directive or order that any Product be recalled, or (ii) a court of competent
jurisdiction orders such a recall, or (iii) Eon reasonably determines, after
consultation with Xxxxxx-Xxxxx, that any Product should be recalled because the
Product does not conform to Specifications, or (iv) Xxxxxx-Xxxxx, after
consultation with Eon, reasonably determines that any product should be
recalled for any reason, the parties will take all appropriate corrective
actions reasonably requested by the other party or by the FDA. In the event
that any such recall results from the breach of Eon' warranties or obligations
under this Agreement, or Eon is otherwise responsible for the recall, Eon will
be responsible for all of the expenses of the recall. In the event that any such
recall results from the breach of Xxxxxx-Xxxxx'x warranties or obligations under
this Agreement, or Xxxxxx-Xxxxx is otherwise responsible for the recall,
Xxxxxx-Xxxxx will be responsible for all of the expenses of the recall. For the
purposes of this Agreement, the expenses of the recall will include, without
limitation, all expenses for notification of customers and the destruction or
return of the recalled Product, as well as all reasonable out-of-pocket costs
incurred by Eon and Xxxxxx-Xxxxx in connection with any corrective action taken
by Eon and Xxxxxx-Xxxxx. Xxxxxx-Xxxxx will conduct the recall process.
Xxxxxx-Xxxxx and Eon will fully cooperate with the other party to assist in the
recall process as reasonably necessary to complete the process.
11. FORCE MAJEURE. Each party shall be excused for any failure or delay
in performing any of its obligations under this Agreement, if such failure or
delay is caused by Force Majeure, provided that such party shall (a) promptly
notify the other party in writing of the occurrence or circumstance upon which
it intends to rely to excuse its performance, (b) immediately resume
performance after the cause of delay is removed, and (c) use all
commercially reasonable efforts to minimize the duration of such delay. In the
event of a Force
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Majeure affecting Eon's performance, Eon will allocate materials, personnel and
resources equitably and not give any preference to any particular customers
including to Eon itself. For purposes of this Agreement, "Force Majeure" shall
mean any act of God, accident, explosion, fire, storm, earthquake, flood,
drought, riot, embargo, civil commotion, war, act of war, act or order of any
Governmental Authority, inability to obtain or delay in the delivery of raw
materials, parts or completed merchandise by the supplier thereof, or any other
circurnstances or event beyond the reasonable control of the party relying upon
such circumstance or event.
12. CONFIDENTIAL INFORMATION: INTELLECTUAL PROPERTY RIGHTS
12.1 CONFIDENTIALITY. The parties are bound by and will comply with the
terms of that certain Confidentiality Agreement entered into by the parties
effective as of September 8, 2000 (the "Confidentiality Agreement") a copy of
which is attached hereto as Appendix 12.1. The terms and conditions of the
Confidentiality Agreement are hereby incorporated herein by reference, and the
terms of Confidentiality Agreement shall be binding upon the parties to the same
extent as if the terms and conditions thereof were set forth in this Agreement.
12.2 TRADEMARKS, TRADE NAMES, AND INTELLECTUAL PROPERTY.
12.2.1 Each party hereby acknowledges that it does not have, and
shall not acquire, any interest in any of the other party's trademarks or
trade names unless otherwise expressly agreed.
12.2.2 Each party agrees not to use any trade names or trademarks of
the other party, except as specifically authorized by the other party in
writing or under this Agreement both as to the names or marks which may be used
and as to the manner and prominence of use.
12.2.3 Xxxxxx-Xxxxx hereby grants to Eon a non-exclusive license to use
Xxxxxx-Xxxxx'x trade names and/or trademarks as specified by Xxxxxx-Xxxxx in
writing strictly for the purpose of such Labeling and Packaging and to use the
Xxxxxx-Xxxxx logo and trademark to manufacture (or have manufactured) and supply
the Product hereunder and, for the avoidance of doubt, no other license to, or
right in, any of Xxxxxx-Xxxxx'x trade names, trademarks or other intellectual
property rights is hereby granted to Eon. Each use of any trademark, trade name,
logo or other intellectual property rights belonging to Xxxxxx-Xxxxx that is
used on or in conjunction with the Product will inure to the benefit of
Xxxxxx-Xxxxx. If any such use vests in Eon any rights in any trademark, trade
name, logo or other intellectual property rights used by and belonging to
Xxxxxx-Xxxxx, Eon hereby transfers such right to Xxxxxx-Xxxxx or its designee
upon request of Xxxxxx-Xxxxx. Except as otherwise provided in this Agreement,
neither party will use in connection with the Product any trademark, trade
name or logo used by the other party, or any trademark, trade name or logo
confusingly similar therewith, during or after the Term or any Renewal Term of
this Agreement.
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13. INSURANCE. Each party will, at all times during the Term or any
Renewal Term of this Agreement, maintain in full force and effect, for the
benefit of itself and each other, comprehensive general liability insurance
policy which (i) is sufficient to adequately protect against the risks
associated with its ongoing business, including the risks which might
possibly arise in connection with the transactions contemplated by this
Agreement and in any event, will maintain product liability insurance in an
amount not less than five million United States dollars (US$5,000,000) for
each occurrence and in the aggregate, and (ii) provides that it cannot be
terminated or canceled without giving the other party thirty (30) days prior
written notice. Each party's product liability insurance policy will name the
other party as an additional insured. At the inception of this Agreement and
annually thereafter, each party shall furnish the other with a certificate of
insurance evidencing that such insurance coverage is in force.
14. TERMINATION
14.1 TERMINATION. This Agreement may be terminated: (a) by either
party, with termination effective immediately upon written notice to the
opposite party if the opposite party makes an assignment for the benefit of
its creditors, files a voluntary petition under federal or state bankruptcy
or insolvency laws, a receiver or custodian is appointed for that parties
business, or proceedings are instituted against that party under federal or
state bankruptcy or insolvency laws that have not been stayed or dismissed
within sixty (60) days; (b) in the event of a material breach of this
Agreement by either party, by the other party upon sixty (60) days (thirty
(30) days in the case of a payment default) written notice specifying the
nature of the breach, provided that such breach is not cured within that
sixty (60) (or thirty (30) days, as the case may be) day notice period; or
(c) by Xxxxxx-Xxxxx in accordance with Section 6.2.2(b).
14.2 SURVIVAL. Termination of this Agreement under Section 14 or due to
expiration and non-renewal of its term shall not relieve either party of
obligations under this Agreement or for liability for any breach of this
Agreement incurred print to or in connection with its termination, expiration or
non-renewal. The provisions of Sections 6, 9, 10, 11, 12 and 13 and any other
provision which by its terms is intended to survive the termination of this
Agreement will survive the termination, expiration or non-renewal of this
Agreement and remain in full force and effect thereafter. Xxxxxx-Xxxxx shall
have the right, in the event of termination pursuant to Section 14.1(c), to
distribute and sell the Product in its inventory at the date of termination (or
delivered by Eon after the date of termination) for a period of six (6) months
after the date of its last delivery of Product by Eon pursuant to this
Agreement.
15. GENERAL PROVISIONS
15.1 NOTICES. Any notice or other communication hereunder shall be in
writing and shall be deemed given when so delivered in person, by overnight
courier (with receipt confirmed), by facsimile transmission (with receipt
confirmed by telephone or by automatic transmission report) or upon receipt if
sent by certified mail, return receipt requested, as follows (or to such other
persons and/or addresses as may be specified in writing, by proper notice, to
the other party hereto) as set forth in Appendix 15.1 attached hereto.
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15.2 ENTIRE AGREEMENT: AMENDMENT. The parties hereto acknowledge that
this Agreement, together with all documents referred to in this Agreement and
all exhibits and schedules attached hereto; sets forth the entire agreement and
understanding of the parties and supersedes all prior written or oral agreements
or understandings with respect to the subject matter of this Agreement. No
modification of any of the terms of this Agreement, or any amendments thereto,
shall be deemed to be valid unless in writing and signed by the party against
whom enforcement is sought. No course of dealing or usage of trade shall be used
to modify the terms and conditions herein.
15.3 WAIVER. No waiver by either party of any default shall be
effective unless in writing, nor will any waiver operate as a waiver of any
other default or of the same default on a future occasion.
15.4 OBLIGATIONS TO THIRD PARTIES. Each party warrants and represents
that its undertaking under this Agreement do not violate any of its contractual
obligations, express or implied, undertaken with any third party.
15.5 ASSIGNMENT. This Agreement shall be binding upon and inure to the
benefit of the successors or permitted assigns of each of the parties and may
not be assigned or transferred by either party without the prior written
consent of the other, which consent will not be unreasonably withheld. Any
assignments, including but not limited to, sale, transfer, or license of brand
or Products, shall not release the original party hereto from their duties and
obligations under this Agreement.
15.6 GOVERNING LAW. The validity, interpretation and effect of this
Agreement shall be governed by and construed under the laws of the State of New
York, without regard to the principles or laws of any jurisdiction regarding
conflict of laws.
15.7 SEVERABILITY. If any provision hereof should be held invalid,
illegal or unenforceable in any respect in any jurisdiction, then, to the
fullest extent permitted by law, all other provisions hereof shall remain in
full force and effect in such jurisdiction and shall be liberally construed in
order to carry out the intentions of the parties hereto as nearly as may be
possible; PROVIDED, HOWEVER, that nothing herein shall be construed so as to
defeat the overall intention of the parties.
15.8. HEADINGS, INTERPRETATION. The headings used in this Agreement
are for convenience only and are not a part of this Agreement.
15.9 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,shall
constitute one and the same instrument.
15.10 INDEPENDENT CONTRACTOR. The parties agree that each is acting as
an independent contractor with respect to the other and nothing contained in
this Agreement is
11
intended, or is to be construed, to constitute Xxxxxx-Xxxxx and Eon as partners
or joint venturers or Xxxxxx-Xxxxx or Eon as an agent of the other. Neither
party hereto shall have any express or implied right or authority to assume or
create any obligations on behalf of or in the name of the other party or to bind
the other party to any contract, agreement or undertaking.
15.11 REMEDIES. The parties agree, that in addition to any other
relief afforded under the terms of this Agreement or by law, each party has
the right to enforce this Agreement by injunction issued against the other
party, it being understood that both damages and an injunction will be proper
modes of relief and are not to be considered as alternative remedies.
*****
(Continued on next page)
12
IN WITNESS WHEREOF, the parties hereto have each caused this
Agreement to be executed by their duly authorized officers as of the date
first above written.
XXXXXX-XXXXX LABORATORIES, INC. EON LABS MANUFACTURING, INC.
By: /s/ Xxxxxxx Everstab By: /s/ Xxxxx Xxxxx Xxxx
------------------------------------------ -------------------------
Its: /s/ Chairman and Chief Executive Officer Its: V.P. Sales and Marketing
----------------------------------------- -------------------------
13
APPENDIX 1
DEFINITIONS
"Act" means the U.S. Food, Drug and Cosmetic Act, as amended, and
regulations promulgated thereunder.
"Affiliate" shall mean (a) any corporation directly or indirectly
controlling, controlled by, or under common control with (to the extent of
fifty percent (50%) or more of is issued capital entitled to vote for the
election of directors) a Party or (b) any partnership, joint venture or other
entity directly or indirectly controlled by, controlling, or under common
control with (to the extent of fifty percent (50%) or more of voting power or
otherwise having power to control its general activities) a Party, but in each
case only for so long as such ownership or control shall continue.
"ANDA" means the Abbreviated New Drug Application for the commercial
sale of the Product in the United States that has been approved by the FDA.
"Contract Manufacture Agreement" has the meaning set forth in Section
4.1.
"Contract Manufacturer" has the meaning set forth in Section 4.1.
"Earned Royalty" means the royalties paid or payable to Eon under
Section 6.2.
"Effective Date" has the meaning set forth in the first paragraph of
this Agreement.
"FDA" means the United States Food and Drug Administration, or any
successor entity thereto.
"First Commercialization Date" means the first date Eon ships or has
shipped to Xxxxxx-Xxxxx (or its designees) an aggregate of 1,500,000 tablets of
conforming Product delivered in accordance with the terms of the Agreement.
"Force Majeure" has the meaning set forth in Section 10.1.
"Forecast" mess Xxxxxx-Xxxxx'x estimate of the number of Products that
it expects to order from Eon for each of the twelve (12) months following the
month in which such estimate is provided.
"Label," "Labeled," or "Labeling" means all labels and other written,
printed, or graphic matter upon: (i) Products or any container or wrapper
utilized with Product or (ii) any written material accompanying Product.
1
"Market Year" means each twelve (12) month period following the first
day of the month following the First Commercialization Date, and in each
successive anniversary of that date.
"Milestone Payments" has the meaning given in Section 6.1.
"Minimum Royalty" has the meaning given in Section 6.2.
"Net Sales" of the Product means the grass revenues received by
Xxxxxx-Xxxxx or its Affiliates from the sales of the Product, or the sublicense
of its rights with respect to the Product hereunder, by Xxxxxx-Xxxxx to a third
party, other than an Affiliate of Xxxxxx-Xxxxx, less (to the extent included in
the gross revenues) all (i) sales, value-added and other direct taxes and duties
actually paid; (ii) trade, quantity and cash discounts and rebates (including
governmental rebates) directly attributable to the sale of the Product actually
given or made; and (iii) insurance and transportation charges actually paid in
transporting the Product in final form to Xxxxxx-Xxxxx'x customers; (iv)
commissions paid to outside brokers, dealers, or distributors; (v) interest,
service, finance, or sales carrying charge paid by customers for extension of
credit on sales; and (vi) amounts refunded or credited for returned, damaged,
outdated, or defective goods, in each case in the ordinary course of
Xxxxxx-Xxxxx'x business, consistent with prior practice and the practice for
other pharmaceutical products sold by Xxxxxx-Xxxxx, not to exceed in respect of
items (i) through (vi) inclusive an aggregate of 18% of the gross
revenues received for the Product (provided that in each Market Year commencing
in the third Market Year, the parties shall review and negotiate in good faith a
reasonable increase in that percentage based upon changes in business and
practice in the pharmaceutical industry), all as determined in accordance with
generally accepted accounting principles, consistently applied. When
calculating Net Sales, goods placed in Xxxxxx-Xxxxx'x inventory (but not
inventory of a third party) or on consignment shall not be deemed sold until
invoiced to the customer. Xxxxxx-Xxxxx'x intracompany transfers or sales to
subsidiary or Affiliates shall not be regarded as sales for the purpose of this
Agreement. Sales shall be deemed to have been made when invoiced to a third
party purchaser by Xxxxxx-Xxxxx, its subsidiaries or Affiliates. If the Product
is distributed in combination or bundled with one or more other items or
products, the Net Sales from that unit shall be deemed to be the total amount
billed or otherwise recognized with respect to such bundle or combination
(subject to deductions as specified above) multiplied by A/(A+B) (defined
below), but in no event shall the deemed amount be less than the average Net
Sales of units of that Product sold separately in similar quantities in the
Territory in the previous three calendar months. "A" will be the suggested
retail price of the Product when sold separately and "B" will be the
sum of the suggested retail prices of the other items or products when each of
them are sold separately.
"Packaging" means all primary containers, cartons, shipping cases,
inserts or any other like material used in packaging, or accompanying Product.
"Product" means amiodarone 400 mg tablets. It is anticipated that the
Product will initially be available in 30,100 and 500 count bottles (which
shall be manufactured, packaged, labeled
2
and/or finished by Eon (or on behalf of Eon by a contract manufacturer) to meet
the Specifications (as hereinafter defined)).
"Purchase Price" has the meaning given in Section 6.2.
"Royalty Percentage" means a percentage of Net Sales equal in the
first three (3) Market Years to eighteen percent (18%) and in each subsequent
Market Year (including without limitation, any year in a Renewal Term)
equal to eighteen percent (18%) of the first fifty million dollars
($50,000,000) of Xxxxxx-Xxxxx'x Net Sales in that Market Year, and twenty-five
percent (25%) of Xxxxxx-Xxxxx'x Net Sales in that Market Year in excess of
the first fifty million dollars ($50,000,000).
"SOPs" has the meaning given in the definition of "Specifications"
immediately below, and "Eon SOPs" will mean the SOPs of Eon or its contract
manufacturer, as the case may be.
"Specifications" means the specifications for materials, packaging,
components, labeling, finished product and manufacturing controls for the
Products as submitted by Eon or covered under Eon' Standard Operating
Procedures (the "SOPs"), Validation Documentation, policies or covered under
any other materials identified and committed to in any applicable regulatory
application. The Specifications shall include, without limitation: (i)
material and component specifications (including approved suppliers and
distributors; physical, chemical and microbiological specifications, as
appropriate); (ii) labeling specifications (including approved suppliers and
distributors, physical attributes, art proofs); (iii) sampling requirements
(for physical, chemical, microbiological testing); (iv) manufacturing
requirements, including processing and equipment requirements; (v) in-process
control specifications; (vi) packaging requirements, including processing and
equipment requirements; (vii) finished product release requirements
(including testing methodology, equipment requirements, and release
specifications); and (viii) stability specifications (including testing
methodology, equipment requirements and testing specifications).
Specifications are established and may be amended from time to time by Eon.
All Specifications implemented must comply with FDA CGMP requirements and be
consistent with USP, NF and ICH requirements, as appropriate.
"Territory" means the United States, its territories and possessions.
3
APPENDIX 4
MANUFACTURING PROCEDURES
1. SPECIFICATIONS. Eon must, at its expense, manufacture (or have
manufactured) the Product in accordance with the Specifications and CGMP, and
the applicable ANDA.
2. QUALITY ASSURANCE INVESTIGATIONS. Eon is responsible for conducting
full quality assurance investigations per Eon SOP's for any Product found not to
conform with the Specifications and Product warranty of Eon. Eon must
immediately communicate to Xxxxxx-Xxxxx any quality issues or failures of audits
of the FDA that affect Xxxxxx-Xxxxx'x ability to obtain, promote or sell the
Products. Eon will furnish Xxxxxx-Xxxxx with copies of all investigation reports
relating to the Product if so requested.
3. ACCESS TO FACILITIES. Xxxxxx-Xxxxx will have access to the
facilities of Eon (or its Contract Manufacturer, as the case may be) at mutually
agreeable times for the sole purpose of auditing compliance with CGMP as defined
by the Act, and for overall compliance with the Act. Further, absent unusual
circumstances, such audits will be limited to one audit during each calendar
year and will be conducted by a reasonable number of employees of Xxxxxx-Xxxxx
who are subject to the same requirements of confidentiality as Xxxxxx-Xxxxx.
4. LABELING, PACKAGING AND PROMOTIONAL MATERIALS. Eon will furnish to
Xxxxxx-Xxxxx copies of Eon's draft Labeling and Packaging. Xxxxxx-Xxxxx will
revise that Labeling and Packaging to included Xxxxxx-Xxxxx'x logos and
trademarks. Xxxxxx-Xxxxx will prepare and submit to Eon, for its review and
approval, specifications and all artwork and copy, in camera ready form, for all
Packaging and Labeling. Eon will furnish Xxxxxx-Xxxxx a reasonable opportunity
to review and approve all specifications (including art proofs) for Product
Packaging and Labeling before their submission to the printer. The finished
Product delivered to Xxxxxx-Xxxxx shall be complete with all appropriate
Labeling, assembling and Packaging provided by Eon, as approved by
Xxxxxx-Xxxxx. Xxxxxx-Xxxxx will promptly submit its promotional materials for
the Product to Eon for submission by Eon to FDA on a timely basis prior to
initial dissemination of those promotional materials (in accordance with
applicable law and regulation).
5. REJECTED PRODUCTS.
5.1 Within thirty (30) days of receipt of Product, Xxxxxx-Xxxxx will
either accept or reject such Product. Acceptance will not relieve Eon of its
obligations under this Agreement, or otherwise hereunder, and will not affect
Xxxxxx-Xxxxx'x rights if any certification provided by Eon is false or
inaccurate. In the event of rejection, Xxxxxx-Xxxxx'x notice to Eon will specify
in reasonable detail how the Product lot failed to conform to the
Specifications. Eon will have an opportunity to investigate and reevaluate any
such Product. All Products will be submitted to inspection and evaluation in
accordance with Eon's SOPs to determine whether or not they meet the
1
Specifications. As to any Product which do not comply with the Specifications
and are rejected by Xxxxxx-Xxxxx ("Rejected Product"), Eon must, at its expense,
replace that Rejected Product promptly, but in all events within ninety (90)
days of Xxxxxx-Xxxxx'x notice of rejection. Eon will make arrangements with
Xxxxxx-Xxxxx for the return or disposal of all Rejected Product, at Eon's
expense.
5.2 Eon will bear all costs related to the manufacture and destruction
of any Rejected Product. Destruction of Rejected Product will be in accordance
with all applicable laws and regulations, and Eon will indemnify Xxxxxx-Xxxxx
for all claims, damages, costs and expenses, including reasonable attorney's
fees and court costs, incurred by Xxxxxx-Xxxxx relating to Eon's failure to
properly dispose of any Rejected Product.
6. PRODUCT DOCUMENTATION. Eon will test each lot of Product before
delivery to Xxxxxx-Xxxxx, and will provide to Xxxxxx-Xxxxx a Certificate
of Analysis which sets forth the items tested, specifications and test results
for each lot delivered, all in a manner which complies with the ANDA (as the
case may be for the Product), the Act and other applicable laws and regulatory
requirements. The appropriate Certificate of Analysis will accompany each
shipment of Product to Xxxxxx-Xxxxx. Eon will maintain all batch records in
accordance with applicable laws and regulatory requirements, and will make them
available to Xxxxxx-Xxxxx upon reasonable request for review and audit.
7. STABILITY TESTING AND VALIDATION. Eon must perform its standard
stability test program as committed to in the ANDA for the Product and as
defined in Eon's SOPs, the applicable FDA guidelines. Eon will provide
Xxxxxx-Xxxxx with a copy of its stability report, as it becomes available, for
each Product. Eon will within, three (3) business days, after an Out Of
Specification ("OOS") result in the stability testing for a Product, and prior
to re-testing for stability, notify Xxxxxx-Xxxxx of those results.
8. VALIDATION WORK OR ADDITIONAL TESTING. Eon will undertake all
validation work as may be required by the ANDA, CGMP, the Act or other
applicable law, Eon's SOPs, or as otherwise agreed upon by the parties.
9. FDA INSPECTION. Eon must advise Xxxxxx-Xxxxx immediately if Eon
receives notification that an authorized agent of the FDA or other governmental
agency intends to visit the manufacturing facility, if that visit is related
directly to the Product.
2
APPENDIX 6.3
PURCHASE PRICE
1. Subject to paragraph 2 below, the Purchase Price for Product shall
equal the cost of manufacture, including direct cost and allocable overhead,
consistent with customary commercial practice, which shall not exceed (f.o.b.
point of shipment at Eon's loading dock) $5.30 for 30 count bottles, $16.75 for
100 count bottles and $83.50 for 500 count bottles of the Product (the
"Maximum Purchase Price"). Eon shall, upon written request from Xxxxxx-Xxxxx
from time to time, but not more than once in any Market Year, promptly furnish
to Xxxxxx-Xxxxx written documentation maintained by Eon in the ordinary course
evidencing the cost of manufacture, including direct costs and allocable
overhead. Independent accountants selected by Xxxxxx-Xxxxx and reasonably
acceptable to Eon shall have the right to audit Eon (not more than once each
Market Year) to confirm the cost of manufacture). All records disclosed to
Xxxxxx-Xxxxx and its independent accountants in accordance with this Appendix
6.3 will be deemed to be confidential information of Eon subject to obligations
of confidentiality and non-disclosure under this Agreement. Xxxxxx-Xxxxx'x
accountants may not disclose to Xxxxxx-Xxxxx any information relating to the
business of Eon, except as should properly be contained in any summary to
Xxxxxx-Xxxxx under this Appendix 6.3 or to enable Xxxxxx-Xxxxx to enforce its
rights under this Appendix 6.3.
2. The parties agree that, except as otherwise provided in the
Agreement, the Maximum Purchase Price for the Product shall remain fixed
through the end of the first Market Year (except for increases (or decreases)
resulting from increases (or decreases) in the cost of components aggregating
more than twenty-five percent (25%)). Thereafter, in addition to any
other adjustments provided for in this Appendix 6.3, increases or decreases in
the Maximum Purchase Price may be made by mutual agreement of the parties on an
annual basis prior to the commencement of each Market Year (applicable to the
ensuing Market Year) (or in the case of increase or decrease of components, the
increase or decrease shall be effective immediately, upon receipt by
Xxxxxx-Xxxxx of written notice by Eon of such increase or decrease, for
purchase orders given by Xxxxxx-Xxxxx to Eon following Xxxxxx-Xxxxx'x receipt of
that written notice) based on any actual increase or decrease in the cost of
manufacturing (including without limitation, costs of components, labor and
overhead) in the last twelve (12) months, as evidenced by written documentation
maintained by EON and furnished to Xxxxxx-Xxxxx as reasonably requested by
Xxxxxx-Xxxxx; provided, however, that (except as provided below in this
paragraph) any increase will not exceed the sum of (1) the actual increase in
the cost of components, plus (2) an increase for labor costs and overhead
proportionate to the difference between (a) the United States Producer Price
Index for Industrial Commodities ("PPI") measured at the beginning of such
12-month period and (b) the PPI measured at the end of such 12-month period.
Notwithstanding anything in the immediately preceding sentence to the contrary,
if during this Agreement, there is a change in the manufacturing facility from
the facility where the Product is currently manufactured then, in that event
(and in no event more than once during this Agreement), the cost of labor and
overhead referenced in the preceding sentence may increase by an amount not to
exceed 30% from the labor and overhead costs for the preceding Market Year.
3
APPENDIX 12.1
XXXXXX-XXXXX LABORATORIES, INC.
MUTUAL SECRECY AGREEMENT
This Secrecy Agreement is made effective as of September 5, 2000 by
and between:
THE PARTIES
"USL" & AFFILIATES "NON-USL" & AFFILIATES
Xxxxxx-Xxxxx Laboratories, Inc. Eon Labs Manufacturing, Inc.
a Minnesota Corporation 227 15 N Conduit Avenue
00000 00xx Xxxxxx Xxxxx Xxxxxxxxx, XX 00000
Xxxxxxxxxxx, XX 00000
Telephone: 000-000-0000 Telephone: 000-000-0000
Fax: 000-000-0000 Fax: 000-000-0000
BACKGROUND
Both parties wish to discuss matters that may require each party to
disclose to the other party, in confidence, certain information that the
disclosing party wishes to maintain secret.
Each party is willing to receive the other's confidential information
and maintain it in confidence.
THE AGREEMENT
The parties, intending to be legally bound, have agreed as follows:
THE SUBJECT MATTER TO BE DISCLOSED
1. The information to be disclosed relates to (describe specifically):
Amiodarone manufacturing, sales and marketing plans.
--------------------------------------------------------------------------------
THE MUTUAL SECRECY OBLIGATIONS
2. The disclosing party shall xxxx all written disclosures of its
own confidential information as "CONFIDENTIAL" and the receiving party shall
xxxx as confidential any writings made by it that contain any of the
disclosing party's confidential information. In the event that confidential
information of either party is disclosed orally, and not reduced to writing
and communicated to the receiving party within thirty (30) days following
such oral disclosure, the burden or proof shall be on the disclosing party to
demonstrate the confidential nature and extent of such oral disclosures if it
wishes to enforce any obligation of secrecy.
3. The receiving party shall use the confidential information it
receives from the other party for the limited purpose of evaluating licensing
opportunity and shall not make any other use (commercial or otherwise) of this
information without the prior written consent of the disclosing party.
4. The receiving party shall not transfer any samples or disclose any
confidential information of the disclosing party to any person, firm or
organization other than in confidence to those of its employees and attorneys to
whom disclosures shall be necessary on a "need to know" basis.
5. At all times the receiving party shall protect the other party's
confidential information with at least the same degree of care it uses to
protect its own confidential information, such care to be of the type and
degree of care that would be used by a reasonable and prudent businessperson.
6. The secrecy obligations under Paragraphs 2 through 5 hereof shall
cease to apply after the earliest of the date on which the receiving party
provides the disclosing party with written evidence clearly establishing that
the information which has been treated by the disclosing party as confidential
information:
(a) has become known to the public in the U.S.A. by publication
or otherwise through no fault of the receiving party; or
(b) was known to the receiving party and its value appreciated
before it was obtained from the disclosing party; or
(c) has been disclosed to the receiving party free of any
obligation of confidentiality by a third party who has the
right to disclose the same and who did not derive the
information from the disclosing party; or
(d) as required to be disclosed by judicial authorities; or
(e) five (5) years from the effective date of this Agreement.
TERMINATION OF THE RELATIONSHIP
7. Either party can at any time cease to make further disclosures of
its confidential information, and either party can refuse to accept further
disclosures of confidential information from the other party. However, such
actions shall not relieve either party of its obligations with regard to any
prior disclosures of confidential information.
8. The parties each acknowledge that the confidential information which
they receive from the other is the property of the disclosing party, and the
receiving party has no claim of ownership to the confidential information of the
other party.
9. At the written request of the disclosing party, the receiving
party agrees to return to the disclosing party any samples and all documents
furnished by the disclosing party containing any confidential information
(regardless of form or author), and all copies thereof. In the event the
receiving party has included confidential information of the other party in
any of its own internally prepared documents, the receiving party shall not
be obligated to deliver those internal documents to the disclosing party, but
the receiving party shall collect and segregate all such internal documents
from its other files and shall certify in writing to the disclosing party
that such internal documents: (1) have collected and segregated; (2) will not
be duplicated; and (3) will be maintained confidential in accordance with
this Agreement or have been destroyed.
GENERAL CONDITION
10. Nothing contained herein shall be construed as granting either
party any right or license under any Letters Patent owned and/or controlled by
the other party.
11. This Agreement can be amended only in writing signed by both
parties to this Agreement.
12. This Agreement is made in the State of Minnesota and shall be
governed by the laws of the State of Minnesota (excluding its choice of
laws). All disputes arising out of or relating to this Agreement (including
any questions of fraud or questions concerning the validity or enforceability
of this Agreement) shall, unless earlier resolved by mutual agreement, be
finally settled by arbitration to be held in Minneapolis, Minnesota pursuant
to the then existing Commercial Rules of the American Arbitration
Association. The arbitration panel shall consist of three arbitrators. Each
party shall appoint one arbitrator from among its own management team within
thirty (30) days from the date of filing any demand for arbitration and the
third arbitrator (as well as any other vacancies on the panel) shall be
appointed by the American Arbitration Association. It is the parties desire
that all arbitration be speedily concluded with the hearing to take place and
the award to be made within ninety (90) days of the filing of any demand for
arbitration. Judgment upon the award of a majority of the arbitrators shall
be binding upon the parties hereto and may be entered in any court having
jurisdiction. Specific performance and injunctive relief may be ordered by
the award. Costs and attorney fees shall be paid as the Arbitrator's award
shall specify. As the sole exception to arbitration, each party shall have
the right to obtain injunctive relief, only, from any court having
jurisdiction so as to preserve that party's rights for resolution in any
pending or imminent arbitration proceedings, but no such injunction shall
prohibit or postpone such arbitration proceedings and the injunctions may be
modified or vacated as a result of the arbitration award.
XXXXXX-XXXXX LABORATORIES, INC. AUTHORIZED SIGNER (NON-USL)
By /s/ Xxxxxx X'Xxxxx /s/ F. Xxxxx Xxxx
----------------------------- --------------------------------------
Xxxxxx X'Xxxxx Signature
Vice President of Business
Development /s/ F. Xxxxx Xxxx
--------------------------------------
Typed Name
V.P. Sales and Marketing
--------------------------------------
Title
APPENDIX 15.1
NOTICE
If to Eon: Eon Labs Manufacturing, Inc.
Attention: Xxxxx Xxxxx Xxxx
000-00 Xxxxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxx 00000
Facsimile: (000) 000-0000
With copies to: Xxxx X. Xxxxxxx, Esq.
Xxxxxx Xxxx & Xxxxxx LLP
000 Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Facsimile: (000) 000-0000
If to Xxxxxx-Xxxxx: Xxxxxx-Xxxxx Laboratories, Inc.
Attention: Xxxx Xxxxxxxx
00000 00xx Xxxxxx Xxxxx
Xxxxxxxxxxx, XX 00000-0000
Facsimile: (000) 000-0000
With copies to: Xxxxxxxxx & Xxxxxx P.L.L.P.
0000 XXX Xxxxxx
Xxxxxxxxxxx, XX 00000
Attention: Xxxx X. Xxxxx
Facsimile: (000) 000-0000
1
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