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FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 14, 1999
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
NEW JERSEY 0-19777 22-3103129
(State or other (IRS Employer
jurisdiction of (Commission Identification
incorporation) File Number) Number)
25 UPTON DRIVE
WILMINGTON, MASSACHUSETTS 01887
(Address of principal executive offices, including ZIP code)
(978) 657-7500
(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS.
The Registrant reports that it has received notice from the United States
Food and Drug Administration (the "FDA") that the FDA has rescheduled an
advisory panel meeting to review the Registrant's New Drug Application ("NDA")
to November 5, 1999. The presentation, which was originally scheduled for
earlier this year, will be made to the Dermatologic and Ophthalmic Drugs
Advisory Committee of the FDA.
The Registrant received an "approvable" letter for its NDA from the FDA on
June 28, 1999 in which the agency raised no clinical issues of safety or
efficacy which needed to be addressed prior to approval. Final marketing
approval is dependent on two issues: compliance with FDA's regulations on Good
Manufacturing Practices by all of DUSA's manufacturers; and agreement with the
FDA on product labeling.
The Registrant has submitted revised labeling to the agency. The
Registrant is also aware that the agency has reinspected the third-party
manufacturer of the Registrant's bulk drug, Levulan(R), the Registrant's brand
of 5-aminolevulinic acid HCl. The Registrant is now awaiting the reinspection
report of the agency's Office of Compliance and response to the proposed revised
labeling.
The Registrant has also received an "approvable" letter for its clinical
trial light source, and will be submitting a PMA amendment to cover its
BLU-U(TM) commercial light source in the near future.
The Registrant also reported that it had concluded a Purchase and Supply
Agreement with the manufacturer of Registrant's Kerastick(TM) brand applicator
for sale in the United States and Canada. The agreement provides for a
commitment to supply all of the Registrant's orders for product, provided
Registrant orders at least a certain percentage of its total commercial
requirements for the territory in a calendar year from the supplier. Firm orders
must be based upon minimum percentages of quarterly rolling forecasts. Prices
for product are based upon quantities ordered and are subject to increases and
decreases depending upon various product cost and competitive market factors
during the five-year term of the agreement.
Registrant has agreed to discuss additional territories with the supplier.
However, if the parties cannot agree on reasonable terms, Registrant is free to
secure alternate sources of supply.
The five-year term may be extended for additional one (1) year periods and
may be terminated earlier by the manufacturer if product orders during a
specified year of the term do not reach certain minimum levels. Similarly,
Registrant may terminate earlier for various breaches of the agreement.
Finally, Registrant reported in a second release that it had initiated a
Phase II clinicial study using topical Levulan(R) (20% solution) photodynamic
therapy with blue
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light in the treatment of facial acne. As previously disclosed, this trial was
expected to be initiated before the end of the year.
Except for historical information, this report, including the exhibits, contains
certain forward-looking statements that involve known and unknown risk and
uncertainties, which may cause actual results to differ materially from any
future results, performance or achievements expressed or implied by the
statements made. These forward-looking statements relate to the FDA Advisory
Committee presentation, the filing of an amendment to its PMA, anticipated
communications from the FDA and discussions with potential marketing partners,
the Company's beliefs and expectations regarding the initiation and conduct of
clinical trials with various parameters and the interpretation of the results,
future research which may be conducted, the Company's intention to develop the
acne indication and commercial opportunities for an acne product. Such risks and
uncertainties include, but are not limited to, the results of future clinical
trials, the status of its patents and proprietary protection for this
indication, reliance on third parties to manufacture (in compliance with FDA
regulations), the uncertainties in the negotiations with potential marketing
partners, the availability of funds for ongoing operations, marketing activities
and further development activities and other risks detailed from time to time in
the Company's United States Securities and Exchange Commission (SEC) filings.
ITEM 7. FINANCIAL STATEMENTS AND OTHER EXHIBITS.
(c) Exhibits
[10.1] Purchase and Supply Agreement between Registrant and North
Safety Products, Inc. dated as of September 13, 1999 portions of
which have been omitted pursuant to a request for confidential
treatment pursuant to Rule 24b of the Securities Exchange Act of
1934.
[99.1] Press Release dated October 8, 1999 regarding FDA Panel
Meeting.
[99.2] Press Release dated October 8, 1999 regarding Acne
Clinical Trial.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
DUSA PHARMACEUTICALS, INC.
By: /s/ D. Geoffrey Shulman
-----------------------------
D. Geoffrey Shulman, MD, FRCPC
President and Chief Executive
Officer
Dated: October 14, 1999
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PURCHASE AND SUPPLY AGREEMENT
This Purchase and Supply Agreement (the "Agreement"), effective as of September
13, 1999 (the "Effective Date"), is made by and between DUSA Pharmaceuticals,
Inc., a New Jersey corporation, having executive offices at 181 University
Avenue, Suite 1208, Toronto, Ontario M5H 3M7, Canada ("DUSA"), and North Safety
Products, Inc., a Delaware corporation and unit of Norcross Safety Products
L.L.C., having offices at 2000 Plainfield Pike, Cranston, RI 02921 U.S.A.
("NSP").
BACKGROUND
A. DUSA has developed a certain formulation of aminolevulinic acid HCl (ALA)
known as Levulan(R) for topical delivery by means of an applicator known as the
Kerastick(R) Applicator.
B. DUSA has secured supply of ALA and desires to secure supply of the combined
ALA-applicator.
C. NSP has the capability and know-how necessary to supply such combined
ALA-applicator, all as set forth herein below.
NOW THEREFORE, for and in consideration of the covenants, conditions, and
undertakings hereinafter set forth, it is agreed by and between the parties as
follows:
ARTICLE I
DEFINITIONS
1.1 "Actual Price" shall mean the actual price per Product unit payable
with respect to Products ordered by DUSA hereunder, based on the actual number
of units ordered by DUSA in any particular calendar year as set forth in Section
2.4 below.
1.2 "Affiliate" shall mean any corporation or other entity which is
directly or indirectly controlling, controlled by or under the common control
with a party hereto. For purposes of this definition, "control" shall mean the
direct or indirect ownership of at least fifty percent (50%) of the outstanding
shares or other voting rights of the subject entity to elect directors, or if
not meeting the preceding, any entity owned or controlled by or owning or
controlling at the maximum control or ownership right permitted in the country
where such entity exists.
1.3 "Aminolevulinic Acid HCl" or "ALA" shall mean the pharmaceutical
composition 5-Aminolevulinic Acid, meeting the specifications set forth on
Exhibit A hereto.
1.4 "Applicator" shall mean the Kerastick applicator used to apply ALA for
treatment of actinic keratosis, as defined in the New Drug Application (NDA)
filed with the FDA for the Product or such other applicator as the parties may
agree in writing.
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1.5 "Approval" shall have the meaning as set forth in Section 7.1 below.
1.6 "Confidential Information" shall have the meaning as set forth in
Section 11.1 below.
1.7 "Control" shall mean possession by a party hereto of the ability to
grant a license or sublicense to particular subject matter as provided for
herein without violating the terms of any in-license agreement or similar
arrangements with any third party under which such subject matter was acquired
by such party to this Agreement.
1.8 "DUSA Technology" shall mean DUSA Patents and DUSA Technical
Information.
1.8.1 "DUSA Technical Information" shall mean confidential
information, tangible and intangible, and materials, including, but not limited
to: pharmaceutical, chemical and biochemical products; technical and
non-technical data and information and/or the results of tests, assays, methods
and processes; and designs, drawings, sketches, plans, diagrams, specifications
and/or other documents containing said information and data; in each case that
is possessed by DUSA as of the Effective Date or discovered, developed or
acquired by DUSA during the term of this Agreement, to the extent such relates
to the manufacture, use or sale of the Product and to the extent that DUSA owns
or Controls the same.
1.8.2 "DUSA Patents" shall mean all patents and all reissues,
renewals, re-examinations and extensions thereof, and patent applications
therefor, and any divisions or continuations, in whole or in part, thereof,
which claim the manufacture, use or sale of the Product and that are owned or
Controlled by DUSA during the term of this Agreement.
1.9 "FDA" shall mean the United States Food and Drug Administration.
1.10 "GMP" shall mean current Good Manufacturing Practices as defined in
the regulations promulgated by the FDA for the manufacturing, processing or
packaging of finished pharmaceuticals, and corresponding regulatory standards
required by other regulatory agencies in the Territory.
1.11 "HPB" shall mean the Canadian Health Protection Branch.
1.12 "Kerastick Trademark" shall mean the "Kerastick" trademark that DUSA
has registered in connection with the Product, or such other trademark that DUSA
registers for use with the Product in jurisdictions in which "Kerastick" is not
selected by DUSA for use.
1.13 "Levulan Trademark" shall mean the "Levulan" trademark that DUSA has
registered in connection with the Product, or such other trademark that DUSA
registers for use with the Product in jurisdictions in which "Levulan" is not
selected by DUSA for use.
1.14 "NSP Technology" shall mean NSP Patents and NSP Technical
Information.
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1.14.1 "NSP Technical Information" shall mean confidential
information, tangible and intangible, and materials, including, but not limited
to: pharmaceutical, chemical and biochemical products; technical and
non-technical data and information, and/or the results of tests, assays, methods
and processes; and designs, drawings, sketches, plans, diagrams, specifications
and/or other documents containing said information and data; in each case that
is possessed by NSP as of the Effective Date or discovered, developed or
acquired by NSP during the term of this Agreement, to the extent such relates to
the manufacture, use or sale of the Product and to the extent that NSP owns or
Controls the same. It is understood and agreed that NSP Technical Information
shall include standard operating procedures, validation protocols and assay
methods developed solely by NSP in the course of this Agreement.
1.14.2 "NSP Patents" shall mean all patents and all reissues,
renewals, re-examinations and extensions thereof, and patent applications
therefor, and any divisions or continuations, in whole or in part, thereof,
which claim the manufacture, use or sale of the Product and that are owned or
Controlled by NSP during the term of this Agreement.
1.14.3 "Product" shall mean a single ALA-Applicator combination
meeting the Specifications.
1.15 "Provisional Price" shall mean the price per Product unit paid to NSP
as set forth in Section 2.8.1 below, based on the Forecasted quantities as set
forth in Section 2.3 below.
1.16 "Specifications" shall mean the specifications set forth in Exhibit
B, as may be modified in accordance with Section 3.5 below.
1.17 "Territory" shall mean the United States and Canada.
ARTICLE II
SUPPLY
2.1 Product Supply. Subject to the terms and conditions of this Agreement,
NSP shall supply to DUSA quantities of the Products ordered by DUSA from time to
time during the term of this Agreement. Subject to Section 6.2 below, DUSA
agrees to order at least [c.i.] of its commercial requirements of Products
ordered for delivery in each calendar year during the term of this Agreement for
sale in the Territory. No more often than [c.i.], NSP shall have the right to
verify that DUSA has fulfilled the foregoing purchase obligations through an
independent third party accountant engaged by NSP, who shall be obligated not to
disclose any of DUSA's records to NSP. The parties recognize and acknowledge
that DUSA's business may be dependent on the supply of Products to DUSA by NSP
as specified hereunder.
2.2 ALA Supply. Notwithstanding anything herein to the contrary, it is
understood and agreed that NSP's obligation to supply Products hereunder is
subject to DUSA making available adequate quantities of ALA. Accordingly, DUSA
agrees to supply [c.i.] (directly or through a third
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party) quantities of ALA to NSP as NSP reasonably notifies DUSA that it will
require to fulfill its supply obligations hereunder. Without limiting the
foregoing and subject to DUSA making such quantities of ALA available, NSP shall
maintain an inventory of ALA on its premises equal to the greater of [c.i.] or
(ii) the amount necessary to produce [c.i.] of the Product forecasted pursuant
to Section 2.3 for the upcoming [c.i.] period.
2.2.1 Acceptance. Within [c.i.] of receipt of any shipment of ALA
supplied by or on behalf of DUSA hereunder, NSP shall inspect (or have
inspected) such ALA and perform the quality performance tests specified on
Exhibit C to ensure that such ALA meets the specifications set forth on Exhibit
A therefor. For avoidance of doubt, if NSP fails to so inspect and test any ALA
delivered to NSP hereunder within the time specified above, NSP shall bear the
risk such ALA fails to meet the specifications therefor. If any ALA delivered to
NSP hereunder fails to meet the specifications therefor, NSP shall immediately
notify DUSA in writing and provide DUSA with a sample of such nonconforming ALA.
2.2.2 Use. NSP shall use and store all ALA provided hereunder in
accordance with all reasonable written instructions provided by DUSA. NSP agrees
to use its best efforts to minimize the wastage of ALA involved in the
production of Product hereunder so as to maximize Product yields. Without
limiting the foregoing, NSP shall use all quantities of ALA provided hereunder
for the sole purpose of producing Products ordered by DUSA hereunder. In
addition, promptly after [c.i.] from the first order placed by DUSA under
Section 2.4 below, the parties agree to establish a minimum yield level for
ALA/Product based on the yield levels for such [c.i.] period (the "Minimum Yield
Level"), thereafter if the ALA/Product yields fall below the Minimum Yield Level
for any rolling [c.i.] period during the term of this Agreement, DUSA shall have
the right to credit the cost of the additional ALA used against amounts due to
NSP for Product pursuant to Section 2.5 below, provided there are no material
changes in the formulation or process of producing Products. Without limiting
the foregoing, in the event there are material changes to the formulation or
process of producing Products in accordance with Section 3.5 below, the parties
shall revise the Minimum Yield Levels to reflect such changes.
2.3 Forecasts. During the term of this Agreement, at least [c.i.] prior to
the start of each calendar quarter ("Q1"), DUSA shall provide NSP with a rolling
written forecast of the quantities of Products estimated to be required on a
[c.i.] basis during Q1 and the next three (3) quarters ("Q2", "Q3" and "Q4",
respectively).
2.4 Orders.
2.4.1 Orders. Together with each forecast provided under Section 2.3
above (the "Current Forecast"), DUSA shall place a firm order with NSP: (a) for
delivery in Q1 the quantity of Product forecasted for Q1 in the Current
Forecast, (b) for delivery in Q2 at least [c.i.] of the quantity of Product
forecasted for Q2 in the Current Forecast, and (c) for delivery in Q3 at least
[c.i.] of the quantity of Product forecasted for Q3 in the Current Forecast. In
other words, the quantity of Product forecasted for Q2 in the Current Forecast
shall not be reduced by more than [c.i.] as it rolls
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to Q1 in the next forecast, and the quantity of Product forecasted for Q3 in the
Current Forecast shall not be reduced by more than [c.i.] as it rolls to Q1. For
avoidance of doubt, it is understood that DUSA may order additional quantities
of Product for delivery hereunder in accordance with the lead times therefor and
subject to NSP's total capacity constraints. NSP shall accept such orders from
DUSA, subject to the remaining terms and conditions of this Agreement.
2.4.2 Form of Orders. DUSA's orders shall be made pursuant to a
written purchase order which is in a form mutually acceptable to the parties,
and shall provide for shipment in accordance with reasonable delivery schedules
and lead times as may be agreed upon from time to time by NSP and DUSA; provided
that the maximum lead time within the current quarter shall not exceed [c.i.]
unless otherwise mutually agreed, however, lead times for the initial order
hereunder shall be [c.i.]. ANY ADDITIONAL OR INCONSISTENT TERMS OR CONDITIONS OF
ANY PURCHASE ORDER, ACKNOWLEDGMENT OR SIMILAR STANDARDIZED FORM GIVEN OR
RECEIVED PURSUANT TO THIS AGREEMENT SHALL HAVE NO EFFECT AND SUCH TERMS AND
CONDITIONS ARE HEREBY EXCLUDED.
2.5 Price. Subject to Section 10.2.1(A) below, the price to be paid by
DUSA per Product unit ordered by DUSA shall be based upon the quantities of
Products ordered by DUSA for delivery by NSP during a particular calendar year
as set forth on Exhibit D. For avoidance of doubt it is understood that the
prices quoted on Exhibit D are based upon the total cumulative quantities of
Products ordered by DUSA for delivery during a particular calendar year, and not
the quantity of any particular order. Notwithstanding the foregoing, beginning
with calendar year 2000, the prices set forth on Exhibit D shall be subject to
adjustment [c.i.] upon [c.i.] prior written notice to DUSA, provided that the
percentage increase in the prices shall not exceed [c.i.], and no more than
[c.i.] such price increase shall be made in [c.i.]. In addition, the parties
agree to negotiate an equitable adjustment to the price of the Products in the
event of any increase in NSP's costs of component parts for the Products
purchased from a third party supplier of [c.i.] or more, to the extent such cost
increase exceeds the price adjustment described in the preceding sentence. DUSA
shall have the right to verify the cost increases set forth in the preceding
sentence through a third party independent accountant engaged by DUSA, who shall
be obligated not to disclose any of NSP's records to DUSA.
2.6 Packaging. Products shall be shipped packaged in containers in
accordance with the Packaging Specifications established under Section 9.1 below
or as otherwise agreed by the parties hereto in writing. Each such container
shall be individually labeled with a description of its contents, including the
manufacturer lot number, quantity of Products, and date of manufacture.
2.7 Delivery. NSP shall deliver quantities of Products ordered by DUSA on
the dates specified in DUSA's purchase orders submitted in accordance with
Section 2.4 above. All Products shall be delivered [c.i.] to the location
specified by DUSA prior to the shipping date therefor. The carrier shall be
selected by agreement between DUSA and NSP, provided that in the event no such
agreement is reached DUSA shall select the carrier. Each shipment shall be
insured for the benefit of DUSA. All [c.i.] as well as any [c.i.], shall be paid
by [c.i.].
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2.8 Invoicing; Payment. NSP shall submit an invoice to DUSA upon shipment
of Products by DUSA hereunder. All invoices shall be sent to the address
specified in the purchase order therefor, and each such invoice shall state the
aggregate and unit price for Products in a given shipment, [c.i.] to the
purchase or shipment initially [c.i.]. All payments hereunder shall be made in
U.S. dollars, by direct bank transfer to an account designated in NSP's invoice.
NSP may [c.i.] if any undisputed invoices at the time of the scheduled shipment
are more than [c.i.] beyond the due date thereof.
2.8.1 Provisional Payment. The Provisional Price due to NSP under
this Section 2.8 shall be made within [c.i.] from the later of (i) DUSA's [c.i.]
or (ii) DUSA's [c.i.]. The Provisional Price shall be based on the forecasted
quantities for a particular calendar year.
2.8.2 Reconciliation. The Provisional Price under which Product was
received shall be reconciled to the Actual Price within [c.i.] following the end
of each calendar year based on actual orders for delivery in such calendar year.
In the event that the Provisional Price paid by DUSA under Section 2.8.1 above
was greater than the amount actually due, DUSA shall be entitled to [c.i.], at
[c.i.] reasonable discretion. In the event that the Provisional Price paid by
DUSA under Section 2.7.1 was less than the amounts actually due hereunder, DUSA
shall pay the difference to NSP within [c.i.] after the end of such year. In
either case, DUSA shall provide to NSP within the [c.i.] period a statement in
reasonable detail setting forth the calculation of actual amounts due hereunder.
ARTICLE III
QUALITY
3.1 Quality. All Products supplied by NSP shall meet the current
Specifications therefor and shall be manufactured in accordance with all
applicable GMP manufacturing and record keeping procedures and Approvals for the
Products in the Territory at NSP's plant located at 2000 Plainfield Pike,
Cranston, RI 02921 (the "Facility"), subject to the limitations of Article 8
below.
3.2 Quality Control. Prior to each shipment of Products, NSP shall perform
quality control procedures and inspections to verify that the Products to be
shipped conform fully with the Specifications. Each shipment of Products shall
be accompanied by a certificate of conformance describing all current
requirements of the Specifications, results of test performed certifying that
the Products supplied have been manufactured, controlled and released according
to the Specifications and all relevant GMP requirements at the Facility
stipulated under Section 3.1 above.
3.3 Acceptance. Acceptance by DUSA of Products delivered by NSP hereunder
shall be subject to inspection and applicable testing by DUSA or its designee.
If on such inspection DUSA or its designee discovers that any Product shipped
hereunder fails to conform with the Specifications or otherwise fails to conform
to the warranties given by NSP in Section 8.1 below, DUSA or such designee may
reject such Products, which rejection shall be accomplished by giving written
notice to NSP specifying the manner in which such Product fails to meet the
foregoing requirements and returning the nonconforming Products in accordance
with NSP's reasonable instructions at NSP's
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expense. For avoidance of doubt, the parties hereby agree that DUSA's reasonable
determination with respect to whether a particular Product conforms to the
Specifications shall be binding on the parties. NSP shall [c.i.] the Products
returned by DUSA within [c.i.]. The [c.i.] shall have priority over the supply
of Products ordered for shipment, [c.i.] before or [c.i.] after the return of
the nonconforming Products to NSP. If a shipment or part thereof is rejected
before the date on which payment is due therefor, DUSA may withhold payment for
such shipment or the rejected portion thereof; if a shipment or portion thereof
is rejected after payment, DUSA may credit the amount paid therefor against
other amounts due to NSP hereunder. The warranties given by NSP in Section 8.1
below shall survive any failure to reject by DUSA under this Section 3.3.
Subject to Article 8 below, Products shall be deemed accepted if no notice to
the contrary is received by NSP within [c.i.] of DUSA's receipt of such
Products.
3.4 Presence At Facility. Upon at least [c.i.] prior written notice given
by DUSA to NSP, DUSA shall have the right to assign a reasonable number of
employees or consultants of DUSA (not to exceed [c.i.] to inspect and audit the
Facility at which Products are manufactured in order to verify NSP's compliance
with GMP and other agreed requirements, provided, however that (i) such
employees or consultants shall not unreasonably interfere with other activities
being carried out at the Facility, and (ii) that such employees or consultants
shall observe all rules and regulations applicable to visitors and to
individuals employed at the Facility.
3.5 Changes. DUSA shall have the right to modify the Specifications from
time to time. All such changes or modifications shall be in writing and shall be
signed by an authorized representative of DUSA and NSP, and shall be effective
for orders of applicable units placed after such notice. If such modifications
result in a material change in NSP's manufacturing costs, the parties shall
agree upon an appropriate adjustment to the price of the Product hereunder; and
if such modifications result in a delay in delivery, the parties shall negotiate
a reasonable extension of the affected lead times. Without limiting the
foregoing, [c.i.] agrees to [c.i.] for inventory of Product components obsoleted
as a result of a modification to the Specifications in accordance with this
Section 3.5 (including [c.i.] of quality assurance and testing therefor) and to
the extent reasonably necessary for [c.i.] Products ordered pursuant to Section
2.4.1 above.
3.5.1 Other [c.i.]. In addition, DUSA agrees to [c.i.] NSP for
[c.i.] as may be reasonable to [c.i.] its [c.i.] necessarily and solely incurred
in the proper performance of this Agreement relating to Product [c.i.] or [c.i.]
as a result of such modifications and [c.i.] of such modifications.
Notwithstanding the foregoing, DUSA [c.i.] any such [c.i.] that NSP is able to
mitigate and NSP shall use its best efforts to mitigate such [c.i.]. All [c.i.]
shall be subject to validation to the reasonable satisfaction of the DUSA. In no
event shall DUSA's total liability under this Section 3.5.1 exceed [c.i.] by
DUSA with respect to such Product [c.i.] if such modification had not been made.
Unless otherwise agreed, all Products, components and other materials for which
DUSA [c.i.] under the provisions of this Section 3.5.1 shall become the property
of DUSA. NSP shall deliver such Products, components and other materials in
accordance with any reasonable instructions that DUSA may specify or use them
solely for the benefit of DUSA.
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3.5.2 [c.i.] . In addition and subject to Section 5.2.2, DUSA agrees
[c.i.] by NSP of [c.i.] or changes to Specifications, if and to the extent that
such [c.i.] are used exclusively by NSP in manufacture or storage of Products
for DUSA hereunder; provided that in each case DUSA consents in writing to the
incurrence of such costs, which consent shall not be unreasonably withheld.
ARTICLE IV
SUPPLY OUTSIDE THE TERRITORY
From time to time as DUSA desires to secure supply of Products for sale outside
of the Territory, DUSA agrees to notify NSP and discuss with NSP for a period of
[c.i.] after such notification the possibility of NSP providing some or all of
such supply. If NSP does not desire to provide such supply or the parties are
unable to agree on the terms and conditions of such supply after such [c.i.] for
any reason, DUSA shall be free to secure one or more alternate sources for its
requirements of Products outside the Territory (including manufacturing such
Products itself), without any further obligation to NSP.
ARTICLE V
LICENSES/TITLE
5.1 To NSP. DUSA hereby grants to NSP a [c.i.] license under the DUSA
Technology to manufacture the Products ordered by DUSA hereunder and deliver
such Products to DUSA or its designee as specified in this Agreement.
5.2 Title.
5.2.1 ALA. As of the Effective Date, NSP has forty kilograms ( 40
kg) of ALA in its inventory which NSP acknowledges was purchased by and is owned
by DUSA and the parties acknowledge that all such ALA shall be used solely for
Product development and testing applications hereunder. In addition, all ALA
provided by or on behalf of DUSA hereunder shall be owned by DUSA.
5.2.2 Equipment. NSP further acknowledges that the equipment and
other materials listed on Exhibit E was purchased by and is owned by DUSA. DUSA
may amend Exhibit E from time to time during the term of this Agreement by
delivering additional equipment or other materials to NSP for use in fulfilling
its supply obligations hereunder.
5.2.3 Other. NSP shall maintain a written record identifying all ALA
owned by DUSA and the equipment and other materials listed on Exhibit E, as
amended (collectively, the "Production Assets") as the property of DUSA. NSP
shall hold the Production Assets at NSP's risk and shall replace the Production
Assets if they are lost damaged or destroyed. In addition, NSP shall maintain
the Production Assets in good condition at NSP's expense and insure the
Production Assets against, loss, theft and damage under a policy naming DUSA as
an additional insured. The Production Assets shall be used solely for the
production of Products for supply to DUSA or its designee hereunder and shall
not be used for the production, manufacture or design of any products
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for any third party without the prior written consent of DUSA. The Production
Assets shall be subject to disposition by DUSA upon expiration or termination of
this Agreement. In either such event, NSP shall deliver the Production Assets to
DUSA or its designee. NSP agrees to cooperate with DUSA, at DUSA's expense, in
the filing of any UCC financing statements relating to the Production Assets as
DUSA may deem necessary or useful.
ARTICLE VI
EXCLUSIVITY/COMPETITIVE PRICING
6.1 Exclusivity. Except as provided in Section 6.2 below, DUSA agrees to
purchase at least [c.i.] of its requirements for Products ordered for delivery
during each [c.i.] during the term of this Agreement for sale in the Territory
from NSP. In consideration of the foregoing, NSP agrees that during the term of
this Agreement NSP shall [c.i.] to third parties without DUSA's prior written
consent.
6.2 Competitive Pricing. If after [c.i.] of the Effective Date and
notwithstanding anything herein to the contrary, DUSA (i) receives a written
quote from a non-Affiliate third party for supply of Products for sale in the
Territory for a price [c.i.] below the price charged by NSP hereunder for such
Products and on terms and conditions at least as favorable as the terms and
conditions herein or (ii) is able to manufacture Product itself (or through an
Affiliate) at [c.i.] the price charged by NSP hereunder for such Products on a
[c.i.] basis calculated in accordance with standard cost accounting principals,
then DUSA may thereafter, as applicable, purchase up to, or manufacture (itself
or through an Affiliate) up to, [c.i.] of the amounts it would otherwise be
required to purchase from NSP hereunder from such third party on [c.i.] written
notice to NSP. Together with such notice DUSA shall provide NSP (A) a copy of
the written quotation from the third party, provided that the name of the third
party supplier may be redacted, or (B) an [c.i.] for Products manufactured by
DUSA, as applicable. NSP shall have the right to verify the third party
quotation or Product costs provided to it in accordance with the preceding
sentence through a third party independent accountant engaged by NSP, who shall
be obligated not to disclose any of DUSA's records to NSP. Notwithstanding the
foregoing, if within [c.i.] after receipt of DUSA's notice to purchase Products
from a third party or manufacture Product itself, NSP notifies DUSA in writing
that it [c.i.] third party's price for Products or [c.i.] its price to [c.i.] of
DUSA's certified cost for manufacturing Product, then the price for Products set
forth on Exhibit D shall be [c.i.] for all Products shipped after that date. To
the extent that DUSA elects to exercise its rights under this Section 6.2, DUSA
shall be relieved of its obligations under Sections 2.3 and 2.4.
ARTICLE VII
REGULATORY MATTERS
7.1 Regulatory Approvals. The parties understand and agree that DUSA,
itself or through its agents, shall have the sole right to correspond with and
submit regulatory applications and other filings to the FDA, HPB or other
regulatory agencies to obtain approvals to import, export, sell or otherwise
commercialize the Products alone or with other products (collectively,
"Approvals") as
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<PAGE> 10
DUSA deems useful or necessary. Accordingly, except as otherwise
required by law, NSP shall not correspond directly with the FDA, HPB or any
other regulatory agency relating to the process of obtaining Approvals or any
obtained Approval for the Products, without DUSA's prior permission.
Notwithstanding the foregoing, NSP agrees to assist DUSA, as requested by DUSA
and [c.i.], in preparing, submitting and maintaining applications for such
Approvals.
7.2 Information. Without limiting the provisions of Section 7.1 above, NSP
shall promptly provide DUSA all written and other information, in NSP's
possession or control, necessary or useful for DUSA to apply for, obtain and
thereafter maintain Approvals for the Products including without limitation
information relating to the Facility, process, methodology or components used in
the manufacture, processing, or packaging of the Products or other such
information required to be submitted to the FDA (or its foreign equivalent) in
the form of a marketing application. Without limiting the foregoing and subject
to Section 7.5 below, NSP agrees to immediately inform DUSA when any such
information is no longer current and reflective of current manufacturing
practices, procedures or the Specifications and to provide updated information
to DUSA. For avoidance of doubt, to the extent such the information provided to
DUSA under this Section 7.2 is Confidential Information of NSP the same shall be
subject to the provisions of Article 11 below. Without limiting the foregoing,
it is understood upon termination of this Agreement, DUSA agrees to return to
NSP, that information and documents provided to DUSA under this Section 7.2 and
in DUSA's control, provided, however, it is understood and acknowledged by NSP
that certain information and documents once provided to the FDA or other
regulatory agency cannot be returned.
7.3 Inspections. NSP shall permit the FDA, HPB and other regulatory
agencies to conduct inspections of the Facility as the FDA or such other
regulatory agencies may request, and shall cooperate with the FDA, HPB or such
other regulatory agencies with respect to such inspections and any related
matters, in each case related to the Product. NSP agrees to give DUSA prior
notice (when possible) of any such inspections, and to keep DUSA informed about
the results and conclusions of each such regulatory inspection, including
actions taken by NSP to remedy conditions cited in such inspections. In
addition, NSP shall allow DUSA or its representative to assist in the
preparation for and be present at such inspections. NSP shall provide DUSA with
copies of any written inspection reports issued by such agencies and all
correspondence between NSP and the agency related thereto, including, but not
limited to, FDA Form 483, Notice of Observation, and all correspondence relating
thereto, in each case relating to the Product or general manufacturing concerns
(i.e., facility compliance or the like). DUSA and its regulatory consultants,
agents, marketing partners or other third parties agreed upon in advance by NSP,
under reasonable confidentiality requirements, shall have access, to all quality
assurance and GMP audits of NSP for the purposes of assessment of regulatory
compliance, to the buildings, records and areas of the Facility involved in the
manufacture, testing, storage and shipment of the Products.
7.4 DUSA Cooperation. DUSA agrees to keep NSP reasonably informed as to
the status of Approvals for Products supplied hereunder.
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<PAGE> 11
7.5 Maintenance of Approvals. Notwithstanding anything herein to the
contrary, NSP shall not undertake any modifications to the Product manufacturing
or testing processes that could delay or otherwise impact the Approvals or other
regulatory submissions, including without limitation, regulatory product
reviews, Investigational New Drug applications (INDs), New Drug Applications
(NDAs) or any other compliance status without prior written agreement of DUSA.
NSP shall obtain and maintain all licenses, permits and registrations necessary
to manufacture the Products and supply them hereunder.
7.6 Reporting. Pursuant to the FDA's and other applicable regulatory
agency's regulations and policies, DUSA may be required to report to such
regulatory agency information that reasonably suggests that a Product may have
caused or contributed to the death or serious injury. Accordingly, NSP agrees to
inform DUSA of any such information promptly after becoming aware of it so that
DUSA can comply with such reporting requirements.
ARTICLE VIII
PRODUCT WARRANTIES/SERVICE
8.1 Product Warranties. NSP warrants and represents that:
8.1.1 Specifications. All Products supplied hereunder shall comply
with the Specifications and shall conform with the information shown on the
certificate of analysis provided for the particular shipment according to
Section 3.2 hereof;
8.1.2 GMP. The Facility, and all Products supplied hereunder, meet
all applicable regulatory requirements (including applicable GMP regulations)
imposed by applicable regulatory agencies with respect to any Approval;
8.1.3 Compliance with FFDCA. None of the Product supplied to DUSA
hereunder shall be adulterated or misbranded within the meaning of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C.Section 301 et seq.; as amended and in
effect of the time of shipment; provided, however, that this provision shall not
apply to, and NSP shall have no responsibility for, misbranding caused directly
by DUSA as a result of labels or package text specified by DUSA for the
Products, nor for misbranding or adulteration caused by any adulterated or
misbranded ALA supplied by DUSA to NSP;
8.1.4 Timing. All Product supplied to DUSA hereunder shall have
completed manufacture within [c.i.] prior to receipt by DUSA; and
8.1.5 No Encumbrance. Title to all Products supplied hereunder shall
pass as provided herein free and clear of any security interest, lien, or other
encumbrance.
8.2 Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION 8.1, NSP
MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AS TO THE PRODUCTS, AND
NSP HEREBY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES
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<PAGE> 12
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE FOR ALL PRODUCTS SUPPLIED
BY NSP TO DUSA HEREUNDER.
8.3 Recalls. In the event that DUSA is required by any regulatory agency
to recall the Products or if DUSA voluntarily initiates a recall of the Products
and in either case if such recall is a result of a breach any of the warranties
under Section 8.1.1 through 8.1.4 above, NSP shall bear the out-of-pocket costs
of such recall.
8.4 Claims. Any claim by DUSA under the foregoing warranty shall be made
in writing to NSP not more than [c.i.] after the delivery of the Product by DUSA
or DUSA's consignee.
ARTICLE IX
TRADEMARKS
9.1 Packaging and Labeling. The trade dress, style of packaging and the
like with respect to the Products will be determined by DUSA in consultation
with NSP so as to be consistent with DUSA's standard trade dress and style and
all applicable regulatory requirements (the "Packaging Specifications"). NSP
shall be responsible for packaging and labeling the Products delivered hereunder
in accordance with the Packaging Specifications.
9.2 Trademarks. Without limiting the provisions of Section 9.1 above,
packaging materials and labels for the Products shall display the Levulan
Trademark, Kerastick Trademark and the DUSA trade name (collectively, the "DUSA
Marks"). Accordingly, DUSA hereby grants to NSP a license to use the DUSA Marks
for the term of this Agreement for the purposes of supplying the Products
hereunder. The ownership and all goodwill from the use of the DUSA Marks shall
vest in and inure to the benefit of DUSA. NSP hereby acknowledges DUSA's
ownership rights in the DUSA Marks, and accordingly agrees that at no time
during or after the term of this Agreement to challenge or assist others to
challenge the DUSA Marks or the registration thereof or attempt to register any
trademarks, marks or trade names confusingly similar to such DUSA Marks.
9.3 Recordation. In those countries of the Territory where a trademark
license must be recorded, DUSA, [c.i.], will provide and record a separate
trademark license for the DUSA Marks. NSP shall cooperate in the preparation and
execution of such documents [c.i.].
ARTICLE X
TERM AND TERMINATION
10.1 Term. The term of this Agreement shall commence on the Effective Date
and continue in full force until the fifth anniversary of the Effective Date,
unless terminated earlier in accordance with this Article 10. This Agreement may
be extended for additional [c.i.] periods by mutual written agreement of NSP and
DUSA at least [c.i.] prior to expiration of the then-current term hereof;
provided, however, that neither NSP nor DUSA shall be obligated to approve any
such
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<PAGE> 13
extension and shall have no liability whatsoever by reason of any failure to
agree on any such extension.
10.2 Termination.
10.2.1 By DUSA.
(A) Late Shipments. In the event that [c.i.] Late Shipments of
Product occur hereunder in any calendar year, the Price with respect to units of
Product shipped or to be shipped in such [c.i.] Late Shipment in any year shall
be reduced by [c.i.]. In the event that [c.i.] Late Shipments of Product occur
hereunder in any calendar year, DUSA shall have the right to terminate this
Agreement on [c.i.] prior written notice, provided that such notice is given
within [c.i.] after the particular Late Shipment giving rise to such right. For
purposes of this Section 10.2.1(A) "Late Shipment" shall mean a failure by NSP
to supply quantities of Product ordered in accordance with Section 2.4 hereof,
which failure remains uncured for [c.i.] following the scheduled shipping date
of such Product.
(B) Defective Product. This Agreement may be terminated by
DUSA upon [c.i.] prior written notice if: (i) [c.i.] of the Product supplied in
each of any [c.i.] shipments during any rolling [c.i.] period fail to conform to
Specifications, or (ii) [c.i.] of the Product supplied in each of any [c.i.]
shipments during any rolling [c.i.] period fail to conform to Specifications, in
each case which failure is not cured within [c.i.] following notice from DUSA
and notice of termination is given within [c.i.] following the last of such
uncured nonconformity or any subsequent uncured nonconformity within such [c.i.]
period.
10.2.2 By NSP. NSP may terminate this Agreement upon [c.i.] prior
written notice to DUSA, if the total Product units ordered by DUSA for delivery
during the period from [c.i.]to [c.i.] of this Agreement is not [c.i.]. For
avoidance of doubt it is acknowledged that in the event of such failure under
this Section 10.2.2 NSP will have the right to give notice as early as [c.i.] of
this Agreement.
10.2.3 Either Party. Without limiting Section 10.2.1 above, this
Agreement may be terminated by either party if the other party breaches any
material term or condition of this Agreement and fails to remedy the breach
within [c.i.] after being given written notice thereof.
10.3 Effect of Expiration or Termination.
10.3.1 Accrued Obligations. It is understood that termination or
expiration of this Agreement shall not relieve a party from any liability which,
at the time of such termination or expiration, has already accrued to the other
party.
10.3.2 Assistance. In the event that DUSA terminates the Agreement
pursuant to Section 10.2 above as a result of breach by NSP, NSP shall
reasonably cooperate with DUSA to
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<PAGE> 14
establish supply of Products, including sources of components and other
materials; provided that such assistance shall not require NSP to transfer or
license any of the NSP Technology unless the parties otherwise mutually agree in
writing.
10.3.3 Survival. The provisions of Sections 8.1, 8.2 and 10.3 and
Articles 1, 11, 13 and 14 shall survive the termination of this Agreement for
any reason. Except as otherwise expressly provided in this Article 10, all other
rights and obligations of the parties shall terminate upon termination of this
Agreement.
ARTICLE XI
CONFIDENTIALITY
11.1 Confidential Information. The parties may from time to time disclose
to each other Confidential Information. "Confidential Information" shall mean
any information disclosed by one party to the other party hereto which if
disclosed in tangible form is marked "confidential" or with other similar
designation to indicate its confidential or proprietary nature 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 forty-five
(45) days after such disclosure. Notwithstanding the foregoing or anything
herein to the contrary, Confidential Information shall not include any
information that, in each case as demonstrated by written documentation: (i) was
already known to the receiving party, other than under an obligation of
confidentiality, at the time of disclosure; (ii) was generally available to the
public or otherwise part of the public domain at the time of its disclosure to
the receiving party; (iii) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement; or (iv) was
subsequently lawfully disclosed to the receiving party by a person other than
the disclosing party.
11.2 Confidentiality. Each party agrees to hold and maintain in strict
confidence all Confidential Information of the other party. Without limiting the
foregoing, neither party shall use or disclose the Confidential Information of
the other party, except as otherwise permitted by this Agreement or as may be
necessary or useful to exercise its rights or perform its obligations under this
Agreement. Nothing contained in this Article 11 shall prevent either party from
disclosing any Confidential Information of the other party to (a) regulatory
agencies for the purpose of obtaining approval to distribute and market the
Products (or products incorporating the Products); provided, however, that all
reasonable steps are taken to maintain the confidentiality of such Confidential
Information to be disclosed; (b) to accountants, lawyers or other professional
advisors or in connection with a merger, acquisition or securities offering,
subject in each case to the recipient entering into an agreement to protect such
Confidential Information from disclosure; or (c) is required by law or
regulation to be disclosed; provided, however, that the party subject to such
disclosure requirement has provided written notice to the other party promptly
upon receiving notice of such requirement in order to enable the other party to
seek a protective order or otherwise prevent disclosure of such Confidential
Information.
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ARTICLE XII
REPRESENTATIONS AND WARRANTIES
12.1 NSP. NSP represents and warrants that: (i) it has full power to enter
into this Agreement and to grant to DUSA the rights granted to DUSA hereunder;
(ii) it has obtained all necessary corporate approvals to enter into and execute
the Agreement; and (iii) NSP shall fully comply with the requirements of any and
all applicable federal, state, local and foreign laws, regulations, rules and
orders of any governmental body having jurisdiction over the activities
contemplated by this Agreement and to the extent applicable to NSP.
12.2 DUSA. DUSA represents and warrants that: (i) it has full power to
enter into the Agreement; (ii) it has obtained all necessary corporate approvals
to enter and execute into this Agreement; (iii) DUSA shall fully comply with the
requirements of any and all applicable federal, state, local and foreign laws,
regulations, rules and orders of any governmental body having jurisdiction over
the activities contemplated by this Agreement and to the extent applicable to
DUSA; and (iv) none of the ALA supplied by DUSA shall be adulterated or
misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, 21
U.S.C. Section 301 et seq., as amended and in effect of the time of supply.
12.3 Disclaimer. EXCEPT AS PROVIDED IN THIS ARTICLE 12 AND SECTION 8.1
ABOVE, NEITHER PARTY MAKES ANY WARRANTIES OR CONDITIONS (EXPRESS, IMPLIED,
STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF AND EACH PARTY
EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL WARRANTIES.
ARTICLE XIII
INDEMNIFICATION
13.1 DUSA. DUSA shall indemnify, defend and hold harmless NSP, its
directors, officers, employees, agents, successors and assigns from and against
any liabilities, expenses or costs (including reasonable attorneys' fees and
court costs) arising out of any claim, complaint, suit, proceeding or cause of
action against any of them by a third party alleging physical injury or death
resulting from (i) the clinical testing of the Products by or on behalf of DUSA;
(ii) the promotion, distribution, sale, handling, possession, or use of the
Products by or on behalf of DUSA following acceptance of such Product in
accordance with Section 3.3 above; (iii) the negligent or intentionally wrongful
acts or omissions of DUSA; and (iv) any breach by DUSA of its representations
and warranties under Section 12.2 above, in each case subject to the
requirements set forth in Section 13.3 below. Notwithstanding the foregoing,
DUSA shall have no obligations under this Article 13 for any liabilities,
expenses or costs arising out of or relating to claims covered under Section
13.2 below.
13.2 NSP. NSP shall indemnify, defend and hold harmless DUSA, its
directors, officers, employees, agents, successors and assigns from and against
all liabilities, expenses, and costs
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<PAGE> 16
(including reasonable attorneys' fees and court costs) arising out of any claim,
complaint, suit, proceeding or cause of action against any of them by a third
party alleging physical injury or death resulting from (i) the negligent or
intentionally wrongful acts or omissions of NSP; and (ii) any breach by NSP of
any of its representations and warranties under Sections 8.1 or 12.1, in each
case subject to the requirements set forth in Section 13.3 below.
13.3 Indemnification Procedure. A party that intends to claim
indemnification (the "Indemnitee") under this Article 13 shall promptly notify
the indemnifying party (the "Indemnitor") in writing of any third party claim,
suit or proceeding included within the indemnification described in this Article
13 above (each a "Claim") with respect to which the Indemnitee intends to claim
such indemnification, and the Indemnitor shall have sole control of the defense
and/or settlement thereof; provided that the Indemnitee shall have the right to
participate, at its own expense, with counsel of its own choosing in the defense
and/or settlement of such Claim. The indemnification under this Article 13 shall
not apply to amounts paid in settlement of any Claim if such settlement is
effected without the consent of the Indemnitor. The Indemnitee under this
Article 13, and its employees, at the Indemnitor's request and expense, shall
provide full information and reasonable assistance to Indemnitor and its legal
representatives with respect to such Claims.
ARTICLE XIV
GENERAL
14.1 Governing Law. This Agreement shall be governed by, and construed and
interpreted in accordance with, the laws of the United States and the State of
New Jersey without reference to conflict of laws principles and excluding the
1980 U.N. Convention on Contracts for the International Sale of Goods. The
parties hereby submit, subject to Section 14.2 below, to the exclusive
jurisdiction and venue of the state courts in New York, New York (or, if there
is exclusive federal jurisdiction, the United States District Courts in New
York, New York), and the parties consent to the personal and exclusive
jurisdiction of these courts.
14.2 Disputes. If NSP and DUSA, are unable to resolve any dispute between
them, either NSP or DUSA may, by written notice to the other, have such dispute
referred to the Chief Executive Officers (or equivalent) of NSP and DUSA, for
attempted resolution by good faith negotiations within [c.i.] after such notice
is received. Unless otherwise mutually agreed, the negotiations between the
designated officers shall be conducted by telephone, within [c.i.] and at times
within the period stated above offered by the designated officers of DUSA to the
designated officer of NSP for consideration. If the parties are unable to
resolve such dispute in accordance with the aforementioned procedure or within
such [c.i.] period, either party shall have the right to pursue any and all
other remedies available to such party.
14.3 Implied Obligations. This Agreement sets forth all of the rights and
obligations of the parties with respect to the subject matter hereof.
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14.4 Force Majeure. Nonperformance of any party shall be excused to the
extent that performance is rendered impossible by strike, fire, earthquake,
flood, governmental acts or orders or restrictions, failure of suppliers, or any
other reason where failure to perform is beyond the reasonable control of the
nonperforming party.
14.5 Delays. Time shall be of the essence for the performance of the
party's obligations under this Agreement.
14.6 Assignment. The parties agree that their rights and obligations under
this Agreement may not be assigned or otherwise transferred to a third party
without the prior written consent of the other party hereto. Any assignment in
violation of this Section 14.6 shall be null and void. Notwithstanding the
foregoing, either party may transfer or assign its rights and obligations under
this Agreement to a successor to all or substantially all of its business or
assets relating to this Agreement whether by sale, merger, operation of law or
otherwise; provided that such assignee or transferee has agreed to be bound by
the terms and conditions of this Agreement. Without limiting the foregoing, if
as a result of an assignment by DUSA to a third party in accordance with this
Section 14.6 DUSA's forecasted requirements of Products are substantially
increased, then DUSA agrees to negotiate in good faith with NSP to implement a
new delivery schedule in order to meet such higher demands. Subject to the
foregoing, this Agreement shall be binding upon and inure to the benefit of the
parties hereto, their successors and assigns. In addition, NSP may assign this
Agreement to its Affiliate, provided that NSP agrees in writing to continue to
be responsible for its obligations hereunder.
14.7 Notices. Any notice or report required or permitted to be given or
made under this Agreement by either party shall be in writing and delivered to
the other party at its address indicated below (or to such other address as a
party may specify by notice hereunder) by courier or by registered or certified
airmail, postage prepaid, courier service, or by facsimile; provided, however,
that all facsimile notices shall be promptly confirmed, in writing, by
registered or certified airmail, postage prepaid. All notices shall be effective
as of the date received by the addressee.
If to NSP: North Safety Products
2000 Plainfield Pike
Cranston, RI 02921
Attn: President
Fax: (401)946-6125
with a copy to: Norcross Safety Products
2000 Plainfield Pike
Cranston, RI 02921
Attn: VP-Sales & Marketing
Fax: (401)946-7560
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If to DUSA: DUSA Pharmaceuticals, Inc.
181 University Ave.
Suite 1208
Toronto, Ontario M5H 3M7
Attn: President
Fax: (416)363-6602
with a copy to: Wilson Sonsini Goodrich & Rosati
Professional Corporation
650 Page Mill Road
Palo Alto, California 94304-1050
Attn: Kenneth A. Clark, Esq.
Fax: (650) 493-6811
14.8 Confidential Terms. Except as expressly provided herein, each party
agrees not to disclose any terms of this Agreement to any third party without
the consent of the other party, except to prospective investors and to such
party's accountants, attorneys and other professional advisors or as required by
securities or other applicable laws, in which case the disclosing party shall
seek confidential treatment to the extent available.
14.9 Limitation of Liability. EXCEPT WITH RESPECT TO LIABILITY ARISING OUT
OF ARTICLE XIII OR IN THE CASE OF WILLFUL BREACH, NEITHER PARTY SHALL BE LIABLE
TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY
OR INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED REVENUES OR PROFITS
RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING TO THIS AGREEMENT,
WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR
OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE
POSSIBILITY OR LIKELIHOOD OF SAME. Notwithstanding the foregoing, the limitation
under this Section 14.9 shall apply to a breach by NSP of its obligation to
supply Products hereunder only if at the time of such breach NSP is allocating
all its output to DUSA.
14.10 Headings. Headings included herein are for convenience only, do not
form a part of this Agreement and shall not be used in any way to construe or
interpret this Agreement.
14.11 Non-Waiver. Any waiver of the terms and conditions hereof must be
explicitly in writing. The waiver by either of the parties of any breach of any
provision hereof by the other shall not be construed to be a waiver of any
succeeding breach of such provision or a waiver of the provision itself.
14.12 Severability. Should any section, or portion thereof, of this
Agreement be held invalid by reason of any law, statute or regulation existing
now or in the future in any jurisdiction by any court of competent authority or
by a legally enforceable directive of any governmental body, such
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section or portion thereof shall be validly reformed so as to approximate the
intent of the parties as nearly as possible and, if unreformable, shall be
deemed divisible and deleted with respect to such jurisdiction, but the
Agreement shall not otherwise be affected.
14.13 Independent Contractors. The relationship of DUSA and NSP
established by this Agreement is that of independent contractors. Nothing in
this Agreement shall be construed to create any other relationship between DUSA
and NSP. Neither party shall have any right, power or authority to assume,
create or incur any expense, liability or obligation, express or implied, on
behalf of the other.
14.14 Entire Agreement. The terms and provisions contained in the
Agreement, including the Exhibits hereto, constitute the entire agreement
between the parties and shall supersede all previous communications,
representations, agreements or understandings, either oral or written, between
the parties. No agreement or understanding varying or extending this Agreement
shall be binding upon either party hereto, unless set forth in a writing which
specifically refers to the Agreement signed by duly authorized officers or
representatives of the respective parties, and the provisions hereof not
specifically amended thereby shall remain in full force and effect.
14.15 Counterparts. This Agreement may be executed in counterparts, each
of which shall be deemed an original, but which together shall constitute one
and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused their duly authorized
representatives to execute this Agreement.
DUSA PHARMACEUTICALS, INC. NORTH SAFETY PRODUCTS
By: s/ R. Carroll By: s/ R.A. Peterson
------------------------ ----------------------
Name: Ronald L. Carroll Name: Robert A. Peterson
------------------------ ----------------------
Title:Executive VP & COO Title: President & C.E.O.
------------------------ ----------------------
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EXHIBIT A
AMINOLEVULINIC ACID
[c.i.]
<PAGE> 21
EXHIBIT B
SPECIFICATIONS
Part I
Assumptions for Manufacturing Process [c.i.]
Part II
List of Items/Specifications [c.i.]
Part III
Detailed Specifications [c.i.]
<PAGE> 22
EXHIBIT C
ALA QUALITY PERFORMANCE TESTING
[c.i.]
<PAGE> 23
EXHIBIT D
PRICE
<PAGE> 24
NORTH - (Logo)
NORTH SAFETY PRODUCTS
2000 Plainfield Pike
Cranston, RI 02921
Telephone 401 943 4400
Facsimile 401 946 7560
MEMORANDUM
To Ron Carroll From Barbara Morin
- ------------------------------ -----------------------------------
Subject Price Quote Date April 1, 1999
- ------------------------------ -----------------------------------
Copies File
Here is the pricing for the manufacture of the Levulan(R) Applicator.
Pricing has been based on the following assumptions.
- - Product will be [c.i.]
- - Batch size will be [c.i.]
- - Annual volume will be [c.i.] pieces.
- - Attached specifications are accurate.
Any change to the above assumptions will affect the cost of the applicator.
Levulan(R) Applicator [c.i.]
Terms [c.i.]
Pricing and terms will be confirmed in the Purchase and Supply Agreement that
will include warranty and indemnity terms.
Please contact me at 401-275-2569 if you have any questions.
<PAGE> 25
EXHIBIT E
DUSA EQUIPMENT AND MATERIALS
[c.i.]
<PAGE> 1
INNOVATION IN PHOTODYNAMIC THERAPY
DUSA Pharmaceuticals, Inc.
For Release at 8:00 a.m. on October 8, 1999
DUSA PHARMACEUTICALS REPORTS:
RESCHEDULED FDA ADVISORY PANEL MEETING;
CONTINUED PROGRESS ON NDA "APPROVABLE" STATUS
Wilmington, Massachusetts October 8, 1999 - DUSA Pharmaceuticals, Inc. (NASDAQ
NMS: DUSA) reported today that an FDA advisory panel meeting to review DUSA's
New Drug Application (NDA) on Levulan(R) Photodynamic Therapy for Actinic
Keratoses (AKs) of the face and scalp has been rescheduled to November 5, 1999.
The presentation will be made to the Dermatologic and Ophthalmic Drugs Advisory
Committee of the FDA. This meeting was originally scheduled for earlier this
year. The FDA has informed the Company that the meeting is primarily for
informational purposes, since DUSA has already received an "approvable letter"
for its NDA from the agency on June 28, 1999. At that time the FDA raised no
clinical issues of safety or efficacy which needed to be addressed prior to
approval.
As part of the "approvable letter", the FDA stated that final marketing approval
would be dependent on two issues: compliance with GMPs by all of DUSA's
manufacturers; and agreement with the FDA on revised product labeling.
The Company is now pleased to report that it recently submitted revised product
labeling to the agency, and that the FDA re-inspection of its drug manufacturer
has taken place. with the manufacturer reporting that the inspection went well.
The Company is awaiting the final re-inspection report to be issued by the FDA
Office of Compliance and the FDA's response to the Company's proposed revised
labeling.
The Company has also received an "approvable letter" for its clinical trial
light source, and will be submitting a PMA amendment to cover its BLU-U (TM)
commercial light source in the near future. The Company also recently concluded
a Purchase and Supply agreement with the manufacturer of its Kerastick
Photodetection (PD) for multiple medical indications. PDT and PD utilize
light-activated compounds such as Levulan(R) to induce a therapeutic or
detection effect. DUSA is a world leader in topically or locally applied PDT
and PD. The Company is incorporated in New Jersey, with offices in Wilmington,
MA, Valhalla, NY and Toronto, Ontario.
Except for historical information, this news release contains certain
forward-looking statements that involve known and unknown risks and
uncertainties, which may cause actual results to differ materially from any
future results, performance or achievements expressed or implied by the
statements made. These forward-looking statements relate to the FDA Advisory
Committee presentation, the filing of an amendment to its PMA, anticipated
communications from the FDA and discussions with potential marketing partners.
Such risks and uncertainties include, but are not limited to, the interpretation
of the results of clinical trials, when the Company's NDA filing will receive
marketing approval, reliance on third parties to manufacture (in compliance with
FDA regulations),
<PAGE> 2
unanticipated expenses relating to potential regulatory requests, uncertainties
in the negotiations with potential marketing partners, the availability of funds
for ongoing operations and marketing if products are approved prior to
consummation of a transaction, and other risks identified in the Company's SEC
filings from time to time.
For further information contact:
DUSA Pharmaceuticals, Inc. - D. Geoffrey Shulman, MD, President & CEO or
Shari Lovell, Director Shareholder Services Tel: 416.363.5059 Fax 416.363.6602
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<PAGE> 1
INNOVATION IN PHOTODYNAMIC THERAPY
DUSA Pharmaceuticals, Inc.
For Release at 8:00 a.m. on October 8, 1999
DUSA Pharmaceuticals Initiates Phase II Levulan(R) Photodynamic Therapy Blue
Light Clinical Trial for Acne
Wilmington, Massachusetts, October 8, 1999 -
DUSA Pharmaceuticals, Inc. (NASDAQ:DUSA)reported today the initiation of a Phase
II human clinical study using topical Levulan(R) photodynamic therapy (PDT) with
blue light in the treatment of facial acne.
The study will evaluate the safety and efficacy of multiple treatments using
Levulan(R) topical 20% solution and blue light. Various drug application times
and total light doses will be studied. The trial is being carried out at a
single clinical dermatology site in the United States.
Acne is the most commonly treated skin disease in the United States, accounting
for over 7 million physician visits per year. It affects primarily teenagers and
young adults, and accounts for approximately $400 million in prescription drug
and over-the-counter medicine costs per year.
DUSA previously reported the results of a pilot clinical study in 10 patients
using a single treatment of topical Levulan(R) solution plus non-laser red light
for inflammatory acne of the torso. In that study, Levulan(R) was taken up
selectively in acne lesions, the treatments were well tolerated and no adverse
events were reported. Although it was primarily designed as a safety study and
therefore was not statistically sized, the results suggested that lesions
receiving Levulan(R) PDT with red light cleared more rapidly than control
lesions.
The Phase II study initiated today uses Levulan(R) 20% topical solution and a
non-laser blue light source similar to the one used in DUSA's studies on
Levulan(R) PDT for actinic keratoses (AKs). Compared to red light, blue light
does not penetrate as deeply into the skin but is a far more efficient drug
activator for Levulan(R) PDT.
Dr. D. Geoffrey Shulman, DUSA's President & CEO, stated "We are very pleased to
have initiated this new study that builds on the promising results of our
earlier pilot acne trial, while using a drug dose and light source which have
already been successfully tested in the treatment of AKs. If we can demonstrate
significant clearing of acne lesions using this same combination, it would
represent a major commercial opportunity for DUSA."
DUSA Pharmaceuticals, Inc. is a development stage pharmaceutical company engaged
primarily in the development of Levulan( Photodynamic Therapy (PDT) and
Photodetection (PD) for multiple medical indications. PDT and PD utilize
light-activated compounds such as Levulan( to induce a therapeutic or detection
effect. DUSA is a world leader in topically or locally applied PDT and PD. The
Company is incorporated in New Jersey, with offices in Wilmington, MA, Valhalla,
NY and Toronto, Ontario.
<PAGE> 2
Except for historical information, this news release contains certain
forward-looking statements that involve known and unknown risks and
uncertainties, which may cause actual results to differ materially from any
future results, performance or achievements expressed or implied by the
statements made. These forward-looking statements relate to the initiation and
conduct of a new clinical trial with various parmeters and the potential
commercial opportunity if trials are successful. Such risks and uncertainties
include, but are not limited to, the results of clinical trials, the
uncertainties inherent in the FDA drug approval process, reliance on third
parties to manufacture (in compliance with FDA regulations), the availability of
funds to complete a full development program for this indication, and other
risks identified in the Company's SEC filings from time to time.
For further information contact:DUSA Pharmaceuticals, Inc. - D. Geoffrey
Shulman, MD, President & CEO or Shari Lovell, Director Shareholder Services
Tel: 416.363.5059 Fax 416.363.6602
-30-
