Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXHIBIT 10.1
LEVULAN(R) WHOLESALE AGREEMENT
Agreement ("Agreement") is entered into this 1st day of September, 2002 (the
"Effective Date") by and between DUSA Pharmaceuticals, Inc., a New Jersey
Corporation ("DUSA") with offices at 00 Xxxxx Xxxxx, Xxxxxxxxxx, Xx. 00000, and
Xxxxx Medical Corp., a Delaware corporation ("Xxxxx") with offices at 000 Xxxx
Xxxxxx Xxxxx, Xxx Xxxxxxx, XX. 00000.
WHEREAS, Xxxxx is in the business of providing specialized wholesale
services with respect to dermatology products and fulfilling orders of
dermatology products directly to licensed dermatologists, physicians and
qualified medical institutions; and
WHEREAS DUSA wishes to utilize the services of Xxxxx for the purpose of
collecting and fulfilling orders of the product Levulan(R) in the Territory (as
defined below) under the terms and conditions hereof:
NOW, THEREFORE, in consideration of mutual covenants, agreements and
conditions set forth herein, the parties hereby agree as follows:
1. DEFINITIONS
A. "Product" shall mean Levulan(R)20% topical solution as packaged in
DUSA's proprietary applicator, the Kerastick(R).
B. "Territory" shall mean all states of the United States of America,
including its possessions and territories.
C. "Trade" shall mean all licensed dermatologists, physicians and qualified
medical institutions in the Territory.
D. "Unit of Product" shall mean a package, [C.I.] containing [C.I.]
Kerastick(R)[C.I.].
2. SERVICES
A. Wholesaler: DUSA hereby appoints Xxxxx as its exclusive authorized
wholesaler, to fill and ship orders of the Product to the Trade
within the Territory pursuant to the terms of this Agreement.
B. Acceptance: Xxxxx hereby agrees to act as DUSA's exclusive wholesaler
for the Product in the Territory pursuant to the terms of this Agreement.
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
3. TERM AND TERMINATION
A. This Agreement shall commence on the Effective Date hereof and shall
remain in effect until August 31st, 2003, unless earlier terminated at any time
for any reason by either party upon [C.I.] prior written notice to the other
party. This Agreement shall be automatically renewed for additional one-year
terms at the end of each one-year term, unless either party notifies the other
party at least [C.I.] prior to the expiration of any one-year term, that it does
not intend to renew this Agreement upon expiration. The initial term and any
renewal term are collectively referred to as the "Term". [C.I.]
B. Either party may terminate this Agreement on [C.I.] prior written notice
in the event the other party shall have materially breached any of its
obligations hereunder and such breach shall have continued without cure during
such [C.I.] period.
4. RESPONSIBILITIES OF THE PARTIES
X. Xxxxx shall obtain, and shall maintain in good standing, all required
federal, state and local permits and licenses necessary or advisable for the
wholesaling of the Product in the Territory. Xxxxx shall comply with U.S. Food
and Drug Administration rules and regulations, during the Term, from time to
time, including all applicable GMP's and other federal, state and local laws,
rules and regulations in force in the Territory, including those covering the
sale of, and the payment for, the Product.
X. Xxxxx agrees to provide DUSA with routine Product sales and inventory
reports, by electronic means on a monthly basis. The content and reporting
formats will be mutually agreed upon by the parties within thirty (30) days of
the execution of this Agreement. Xxxxx shall not perform any marketing or
promotional activities with respect to the Product without the express written
consent of DUSA. However, the parties agree that Xxxxx shall include a listing
of the Product in Xxxxx'x catalog and/or current supplement.
C. Assuming DUSA has met its obligations to Xxxxx under Paragraph 6 below,
Xxxxx agrees to fill its customer orders promptly, and acknowledges that its
usual and customary policy is to ship goods within twenty-four (24) hours of
receipt of an order.
X. Xxxxx will ship "Units of Product" to DUSA's customers only in DUSA
approved, validated shipping configurations. DUSA will supply Xxxxx with
packaging specifications for said packaging under separate cover within one
month from the execution of this Agreement. Until such time that DUSA provides
Xxxxx with packaging specifications, Xxxxx will continue to ship "Units of
Product" to DUSA's customers according to the industry's shipping practices for
Product of this type. DUSA and Xxxxx will [C.I.]
2
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
packaging costs that result from packaging specification changes recommended by
DUSA, as compared to Xxxxx'x current packaging costs for the Product.
5. SALE PRICE
The initial sale price to Xxxxx of the Product shall be [C.I.] per Unit of
Product. Xxxxx shall be responsible for the collection and remittance of all
applicable federal, state and local taxes associated with the purchase from DUSA
and subsequent resale of the Product. Xxxxx shall not resell Product for an
amount greater than [C.I.] of the price paid by Xxxxx to DUSA, (E.g. [C.I.] per
Unit of Product based on a [C.I.] purchase price), inclusive of all delivery
charges, fees and the like. DUSA reserves the right to change the "Unit of
Product" price from time to time, by providing thirty (30) days written notice
to Xxxxx of said changes.
6. ORDERS: SUPPLY
Xxxxx shall order from DUSA such quantities of the Product as are necessary
to fulfill its obligations of filling orders it accepts for Products to the
Trade in the Territory. DUSA will ship such quantities of the Product, FOB
Xxxxx. Xxxxx shall place orders of Product in multiples of [C.I.] Units of
Product. Xxxxx shall place orders on a weekly basis or such other periodic basis
as mutually agreed upon by the parties. DUSA shall use commercially reasonable
efforts to promptly fill Xxxxx'x orders, taking into account the availability of
DUSA's supply of Product and the market demand for Product.
7. PAYMENT TERMS
Xxxxx shall pay DUSA for all Unit of Product within thirty-one (31) days of
the date of invoice and Xxxxx shall be entitled to [C.I.] for all payments made
within ten (10) days of the date of invoice. All payments will be made by
electronic means, preferably "ACH", Automated Clearing House. Overdue payments
will be subject to finance charges computed at the lower of one and one half
percent (1.5%) per month or the maximum amount permitted by law. Payment is
considered made once received by DUSA.
8. CONFIDENTIAL INFORMATION
During the Term of this Agreement, and for a period of five (5) years from
the date of termination, or expiration hereof, Xxxxx and XXXX agree to hold in
strict confidence, and shall use all reasonable efforts to maintain the secrecy
of any and all information disclosed by one to the other and either identified
in writing as confidential which shall include the terms of this Agreement, or
if disclosed orally is indicated orally to be confidential or proprietary by the
party disclosing such information at the time of such disclosure and is
confirmed in writing as confidential or proprietary by the disclosing party
within a reasonable time after such disclosure (collectively "Confidential
Information"), and shall not disclose any such Confidential Information to a
third party without the express, written consent of the disclosing
3
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
party, with the exception of the following: (i) information which, at the time
of disclosure, is in the public domain; (ii) information which, after
disclosure, becomes part of the public domain by publication or otherwise, other
than by breach of this Agreement by the receiving party; (iii) information that
the receiving party can establish by competent proof was in its possession at
the time of disclosure and was not acquired, directly or indirectly, from the
disclosing party; (iv) information that the receiving party obtains from a third
party; provided, however, that such information was not obtained by said third
party, directly or indirectly, from the disclosing party under an obligation of
confidentiality known to the receiving party toward the disclosing party; (v)
information disclosed by the receiving party pursuant to court order or as
otherwise required by law, after giving the disclosing party prior written
notice of such required disclosure and after assisting the disclosing party in
its reasonable efforts to prevent or limit such disclosure; and (vi) information
that the receiving party can establish by competent proof was independently
developed by persons in its employ or otherwise who had no contact with and were
not aware of the content of the Confidential Information.
A. The receiving party shall not use the Confidential Information for any
purpose other than in connection with exercising its rights and fulfilling its
obligations hereunder. The receiving party will not disclose any such
Confidential Information to any person other than its officers or employees, and
only then if they have a clear need to know such Confidential Information in
connection with the performance of their professional responsibilities.
B. The receiving party shall take all reasonable steps, including but not
limited to those steps taken to protect its own information, data or other
tangible or intangible property that it regards as proprietary or confidential
to insure that the Confidential Information is not disclosed or duplicated for
the use of any third party, and shall take all reasonable steps to prevent its
officers and employees, or any others having access to the Confidential
Information, from disclosing or making unauthorized use of any Confidential
information, or from committing any acts or making any omissions that may result
in a violation of this Agreement.
C. Title to and all rights emanating from the ownership of all Confidential
Information disclosed under this Agreement shall remain vested in the disclosing
party. Upon written request of the disclosing party, the receiving party shall
return promptly to the disclosing party all written materials and documents, as
well as any computer software or other tangible media that contains Confidential
Information, which was made available or supplied by the disclosing party to the
receiving party, together with any copies thereof.
D. The receiving party agrees that the disclosure of Confidential
Information without the express written consent of the disclosing party will
cause irreparable harm to the disclosing party, and that any breach or
threatened breach of this Agreement by the receiving party will entitle the
disclosing party to injunctive relief, in addition to any other legal remedies
available to it, in any court of competent jurisdiction.
4
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
9. WARRANTY
X. XXXX warrants that each Product supplied hereunder is free from
defects in material and workmanship at the time of delivery and
conforms to DUSA's then current technical specifications or other
descriptive materials supplied by DUSA for the Product, and is not
adulterated or misbranded within the meaning of the U.S. Food, Drug
and Cosmetic Act, 21 U.S.C. Sec. 201 et seq.
X. XXXX MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, WITH RESPECT TO THE
PRODUCT, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE.
X. XXXX sales to Xxxxx will be considered final except that Xxxxx can
return product for full credit [C.I.] prior to and up to [C.I.] after
the expiration date.
D. Any "Units of Product" that require return to DUSA will require a
Returned Goods Authorization number supplied by DUSA Customer Service.
E. Returns will be sent FOB "Xxxxx ship point" and will be subject to
inspection and acceptance.
10. INDEMNIFICATION
X. XXXX shall indemnify and hold Xxxxx, its parent companies, affiliates
and subsidiaries, and the officers, directors and employees of each of them,
harmless from any and all claims of liability, including claims of liability and
liability for death or personal injury, and costs, losses and expenses,
including reasonable attorney's fees, that stem from any Product that was
damaged or defective at the time of delivery to Xxxxx, or resulting from the
negligence or recklessness or willful misconduct of DUSA.
X. Xxxxx shall indemnify and hold DUSA, its parent companies, affiliates
and subsidiaries, and the officers, directors and employees of each of them,
harmless from any and all claims of liability, including claims of liability and
liability for death or personal injury, and costs, losses and expenses,
including reasonable attorney's fees, that stem from Xxxxx'x obligations to
comply with all applicable laws, rules and regulations pertaining to the Product
or resulting from the negligence, recklessness or willful misconduct of Xxxxx.
C. In the event that the negligence, recklessness or willful misconduct of
each of DUSA and Xxxxx contributes materially to any such liability, cost, loss
or expense stemming from any Product supplied or distributed and sold hereunder,
then DUSA and Xxxxx each shall be responsible for that portion of said
liability, cost, loss or expenses to which such negligence, recklessness or
willful misconduct contributed.
D. In the event that one party receives notice of a claim, lawsuit, or
liability for which it is entitled to indemnification by the other party, the
party receiving the notice shall give prompt notification to the indemnifying
party. The party being indemnified shall cooperate fully with the indemnifying
party throughout the pendency of the claim, lawsuit or liability and the
indemnifying party shall have complete control over the conduct with legal
counsel reasonably acceptable to the indemnified party and disposition of the
claim, lawsuit or liability. An indemnified party may obtain separate legal
representation at its own cost.
5
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
The indemnifying party shall not enter into any settlement or agreement binding
upon or imposing liability on the indemnified party without the prior written
consent of the indemnified party which consent shall not be unreasonably
withheld.
11. MISCELLANEOUS
A. Headings: The headings and captions used herein are for the convenience
of the parties only and are not to be construed to define, limit or affect the
construction or interpretation hereof.
B. Severability: In the event that any provision of this Agreement is found
to be invalid or unenforceable, then the offending provision shall not render
any other provision of this Agreement invalid or unenforceable, and all other
provisions shall remain in full force and effect and shall be enforceable,
unless the provisions which have been found to be invalid or unenforceable shall
substantially affect the rights or obligations granted or undertaken by either
party.
C. Entire Agreement: This Agreement contains the entire agreement of the
parties regarding the subject matter hereof and supersedes all prior agreements,
understandings or conditions (whether oral or written) regarding the same. This
Agreement may not be changed, modified, amended or supplemented except by a
written instrument signed by both parties.
D. Assignability: This Agreement and the rights hereunder may not be
assigned or transferred by either party without the prior written consent of the
other party hereto, provided that such consent is not unreasonably withheld;
provided further that this Agreement may be assigned without such consent in the
event DUSA merges, consolidates or sells substantially all of its assets or
transfers voting control of its common stock. In the event that this Agreement
is properly assigned, it shall be binding upon and inure to the benefit of the
parties and their respective successors and assigns.
E. Limitations on [C.I.] Responsibilities: Notwithstanding anything
contained in this Agreement to the contrary, [C.I.] shall have no obligation for
[C.I.] arising from: (1) [C.I.] with products not supplied or approved in
writing by [C.I.] where [C.I.] would not have occurred but for [C.I.] (2) the
[C.I.], where [C.I.] would not have occurred but for [C.I.] (3) the [C.I.] for
which it was not [C.I.] where [C.I.] would not have occurred but for [C.I.] or
(4) a claim based on [C.I.] or any persons, companies or other business entities
controlling, controlled by or under common control [C.I.].
F. Further Assurances: Each party hereto agrees to execute, acknowledge and
deliver such further instruments, and take such other actions, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
6
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
G. Notices and Reports: All notices, consents or approvals required by this
Agreement shall be in writing and sent by certified or registered first-class
mail, postage prepaid or by overnight courier, facsimile or cable (confirmed by
such certified or registered mail) to the parties at the following addresses or
such other addresses as may be designated in writing by the respective parties.
If to DUSA:
DUSA Pharmaceuticals, Inc.
00 Xxxxx Xxxxx
Xxxxxxxxxx, XX 00000
Attn: Xxxx Xxxxxx
With a copy to:
Xxxxxxx X. Xxxxxxx, Esq.
Xxxx Xxxxx LLP
000 Xxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
If to Xxxxx:
Xxxxx Medical Corp.
000 Xxxx Xxxxxx Xxxxx
Xxx Xxxxxxx, XX 00000
Attn: Xxxx Xxxxxx
Notices shall be deemed effective on the date of receipt.
H. Relationships of the Parties: Both parties are independent contractors
under this Agreement. Nothing contained in this Agreement is to be construed so
as to constitute DUSA and Xxxxx as partners, joint venturers or agents with
respect to this Agreement. 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 with any third party. This Agreement does not create a
partnership for United States federal income tax purposes (as defined in Section
761 of the United States Internal Revenue Code), for any United States state,
possession, territory or local jurisdiction. Therefore, there is no requirement
to file Form 1065. United States Partnership Return of Income or any similar
United States state, possession, territory or local income tax return.
I. Audit: DUSA shall have the right to audit Xxxxx for cGMP compliance as
often as is necessary to assure it. Any noncompliance discovered as a result of
said audit(s) would be considered breach under the terms of this Agreement.
Additionally, DUSA shall have the right to audit Xxxxx'x books and records to
determine compliance with the terms of the resale provisions set forth in
Section 5 of this Agreement. DUSA may exercise the right to audit Xxxxx'x books
and records only once per contract year. In either event, if DUSA elects to
7
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
conduct such an audit, the audit shall be conducted at Xxxxx'x place of business
upon reasonable notice and at DUSA's expense.
J. Waiver: The waiver by either party of a breach of any provisions
contained herein shall be effective only if made in writing and shall in no way
be construed as a waiver of any succeeding breach of such provision or the
waiver of the provision itself.
K. Applicable Law: This Agreement shall be governed by and construed in
accordance with the laws of the State of Connecticut, without regard to the
conflicts of law provisions thereof.
L. Force Majeure: A party shall not be liable for nonperformance or delay
in performance (other than of obligations regarding any payments or of
confidentiality) caused by any event reasonably beyond the control of such party
including, without limitation, wars, hostilities, revolutions, riots, civil
disturbances, national emergencies, strikes, lockouts, unavailability of
supplies, epidemics, fires, floods, earthquakes, other forces of nature,
explosions, embargoes, or any other Acts of God, or any laws, proclamations,
regulations, ordinances, or other acts or order of any court, government or
governmental agency, and the inability of such party to obtain material or
Product from its suppliers or to obtain equipment or transportation, for the
time during which such conditions continued, and for a reasonable time
thereafter. Purchases and deliveries of the Product under this Agreement may at
either party's option be suspended, in whole or in part, during the period of
the continuance of such cause or event. Any occurrence of force majeure shall
immediately be reported to the other party in writing.
M. The provisions of Sections 1, 8, 9, 10 and 11 shall survive for a period
of (5) years from the date of termination or expiration of this Agreement.
N. Counterparts: This Agreement may be executed in multiple counterparts,
each of which shall be considered and shall have the force and effect of an
original.
IN WITNESS WHEREOF, by their duly authorized representatives, the parties
have executed this Agreement as of the day and year first above written.
XXXXX MEDICAL CORP. DUSA PHARMACEUTICALS, INC.
By: /s/ Xxxx Xxxxxx By: /s/ Xxxx X. Xxxxxx
--------------------------- --------------------------
Name: Xxxx Xxxxxx Name: Xxxx X. Xxxxxx
------------------------- -------------------
Title: Director, Vendor Relations Title: VP Operations
-------------------------- -------------------
8
