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Execution Copy
PURCHASE AND SUPPLY AGREEMENT
This Purchase and Supply Agreement (the "Agreement"), effective as of 5
November 1998 (the "Effective Date"), is made by and between DUSA
Pharmaceuticals, Inc., a New Jersey corporation, having executive offices at 000
Xxxxxxxxxx Xxxxxx, Xxxxx 0000, Xxxxxxx, Xxxxxxx X0X 0X0, Xxxxxx ("DUSA"), and
National Biological Corporation, an Ohio corporation having offices at 0000
Xxxxxxxxxx Xxxxxxx, Xxxxxxxxx, XX 00000 ("NBC").
BACKGROUND
X. XXXX and NBC entered into a certain Co-Development Agreement on June 2,
1995, as amended of even date herewith (the "Co-Development Agreement") pursuant
to which the parties developed a certain [c.i.]Light Source (as defined below)
useful in photodynamic therapy.
X. XXXX desires to secure supply of the Light Sources as part of the
commercialization of its Levulan(R) products.
C. NBC has the capability and know-how necessary to supply the Light
Sources, 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 1
DEFINITIONS
1.1 "Approval" shall have the meaning as set forth in Section 7.1 below.
1.2 "Blu-U(R) Trademark" shall mean the "Blu-U" trademark that DUSA has
registered in connection with the Light Sources, or such other trademark that
DUSA registers for use with the Light Sources in jurisdictions in which "Blu-U"
is not selected by DUSA for use.
1.3 "Confidential Information" shall have the meaning as set forth in
Section 11.1 below.
1.4 "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.
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1.5 "DUSA Technology" shall mean DUSA Patents and DUSA Technical
Information.
1.5.1 "DUSA Technical Information" shall mean [c.i.], including, but
not limited to: [c.i.]; in each case that is possessed by DUSA as of the
Effective Date or [c.i.] during the term of this Agreement, to the extent such
relates to the [c.i.] of the Light Sources and to the extent that DUSA owns or
Controls the same.
1.5.2 "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 [c.i.] and that are owned or Controlled by DUSA during the term
of this Agreement.
1.6 "FDA" shall mean the United States Food and Drug Administration.
1.7 "Field" shall mean the [c.i.] of medical disorders by light [c.i.]and
includes [c.i.] and the Light Source or [c.i.].
1.8 "Force Majeure Event" shall have the meaning as set forth in Section
14.3 below.
1.9 "HPB" shall mean the Canadian Health Protection Branch.
1.10 "Light Source" shall mean the light sources meeting the
Specifications together with the Stand.
1.11 "NBC Technology" shall mean NBC Patents and NBC Technical
Information.
1.11.1 "NBC Technical Information" shall mean [c.i.], including, but
not limited to: [c.i.]; in each case that is possessed by NBC as of the
Effective Date or [c.i.] during the term of this Agreement, to the extent such
relates to the [c.i.] of the Light Sources and to the extent that NBC owns or
Controls the same.
1.11.2 "NBC 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 [c.i.] and that are owned or Controlled by NBC during the term of
this Agreement.
1.12 "Output Regulating Circuitry System" shall mean, collectively and
individually, the [c.i.] of a Light Source.
1.13 "Plastic Housing" shall mean that portion of the outer plastic
covering of the Light Source designed by DUSA.
1.14 "QS" shall mean current Quality Systems regulations, policies and
guidance documents promulgated by the FDA for the design, manufacture,
processing or packaging of medical devices, and corresponding regulatory
standards required by other regulatory agencies in the Territory. QS shall also
include those Quality Systems requirements specified by DUSA in the
Specifications.
1.15 "Specifications" shall mean the specifications set forth in Exhibit
A, as may be modified
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in accordance with Section 3.6 below.
1.16 "Stand" shall mean the stand for the Light Source meeting the
then-current specifications therefor, which specifications are agreed to and
updated by the parties hereto.
1.17 "Territory" shall mean [c.i.].
ARTICLE 2
SUPPLY
2.1 Light Source Supply. Subject to the terms and conditions of this
Agreement, NBC shall supply to DUSA quantities of the Light Source ordered by
DUSA from time to time during the term of this Agreement. Subject to Sections
5.2.2 and 6.2 below, DUSA agrees to order [c.i.] of Light Sources for the Field
for the Territory from NBC. The parties recognize and acknowledge that DUSA's
business may be dependent on the supply of Light Sources to DUSA by NBC as
specified hereunder.
2.2 Forecasts. During the term of this Agreement, [c.i.] prior to the
start of each calendar half year ("H1"), DUSA shall provide NBC with a rolling
written forecast of the quantities of Light Sources estimated to be required
during H1 and the following calendar half year ("H2").
2.3 Orders.
2.3.1 Orders. Together with each forecast provided under Section 2.2
above (the "Current Forecast"), DUSA shall place a firm order with NBC for
delivery in H1 of the quantity of Light Sources equal to the quantity of Light
Sources reflected for H1 in the Current Forecast. For avoidance of doubt, it is
understood that DUSA may order additional quantities of Light Sources for
delivery hereunder in accordance with the lead times therefor. NBC shall accept
such orders from DUSA, subject to the remaining terms and conditions of this
Agreement.
2.3.2 Form of Orders. DUSA's orders shall be made pursuant to a
written purchase order which is in the form attached hereto as Exhibit B, and
shall provide for shipment in accordance with reasonable delivery schedules and
lead times as may be agreed upon from time to time by NBC and DUSA; provided
that the maximum lead time shall not exceed [c.i.] unless otherwise mutually
agreed. 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.
2.3.3 Delays. DUSA shall be entitled to reschedule deliveries of
Light Sources ordered hereunder, provided that DUSA notifies NBC of such desired
changes, in writing, [c.i.] prior to the scheduled delivery date. Without
limiting the foregoing, if such delay is greater than [c.i.], NBC may [c.i.]
DUSA for the Light Sources so delayed and DUSA will [c.i.] to such Light Sources
[c.i.]; in which case NBC agrees to: (i) maintain a written record identifying
such Light Sources [c.i.], (ii) maintain such Light Sources in good condition
[c.i.], and (iii) [c.i.]. Furthermore, if such rescheduling represents a delay
in shipment of more than [c.i.] from the original delivery date, DUSA shall
[c.i.]on such delayed Light Sources during such extended period and [c.i.]. For
avoidance of doubt, the preceding provisions of this Section 2.3.3 shall not in
anyway limit DUSA's rights of inspection and rejection set forth in
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Section 3.3 below.
2.3.4 Inventory. Without limiting the provisions of this Section 2.3
above, it is understood that in order to accommodate DUSA's requirements of
Light Sources hereunder, DUSA may request that NBC maintain in its inventory
Light Source units ordered by DUSA under Sections 2.3.1 above. In such case,
upon placement of a particular Light Source unit in inventory NBC may [c.i.] in
accordance with [c.i.] on the later of (a)the date which such Light Source unit
are requested to be placed in inventory and (b) the actual date such Light
Source units are included in DUSA's (or its designee's) inventory and DUSA will
[c.i.]; further NBC agrees to: (i) maintain a written record identifying such
Light Sources as [c.i.], (ii) maintain such Light Sources in good condition
[c.i.], and (iii) [c.i.]. In the event that a particular Light Source unit is
held in inventory in excess of [c.i.], DUSA shall [c.i.] on such delayed Light
Sources during such period and [c.i.]. For avoidance of doubt, the preceding
provisions of this Section 2.3.4 shall not in anyway limit DUSA's rights of
inspection and rejection set forth in Section 3.3 below.
2.4 Price. The price to be paid by DUSA per Light Source unit ordered by
DUSA shall be [c.i.] (the "Price"); the Price [c.i.] shall be [c.i.] and [c.i.]
promptly upon [c.i.] of Light Sources in accordance with the prices set forth on
Exhibit C hereto. After which the Price [c.i.] so established shall be
substituted for Exhibit C. Notwithstanding the foregoing, [c.i.] of the
Effective Date, the Prices set forth on Exhibit C shall be [c.i.] shall [c.i.]
in the then current Price for Light Sources hereunder. Such [c.i.] Price shall
be effective for orders placed in accordance with Section 2.3 above after the
Price [c.i.] becomes effective.
2.5 Packaging. Light Sources 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 name, manufacturer lot number, quantity of Light Sources, and date
of manufacture.
2.6 Delivery. NBC shall deliver quantities of Light Sources ordered by
DUSA on the dates specified in DUSA's purchase orders submitted in accordance
with Section 2.3 above. All Light Sources 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 NBC, 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
[c.i.].
2.7 Invoicing; Payment. Unless [c.i.] as set forth in [c.i.], NBC shall
submit an invoice to DUSA [c.i.] of Light Sources ordered by DUSA hereunder. All
invoices shall be sent to the address specified in the purchase order or as
otherwise instructed by DUSA in writing, and each such invoice shall state the
[c.i.] Price for Light Sources 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 [c.i.] designated in NBC's invoice. Payment shall be due to NBC within [c.i.]
from the date of an invoice issued hereunder; provided that payment made within
[c.i.] of the foregoing shall be subject to a [c.i.] percent [c.i.] discount.
Notwithstanding the foregoing, NBC shall invoice [c.i.] separately on a [c.i.]
and DUSA agrees to remit payment therefor within [c.i.]. In addition, such
[c.i.] shall not be subject to the [c.i.] percent [c.i.] discount. [c.i.].
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ARTICLE 3
QUALITY
3.1 Quality. All Light Sources supplied by NBC shall materially conform
with the current Specifications therefor and shall be manufactured in accordance
with all applicable QS manufacturing and record keeping procedures and Approvals
for the Light Sources in the Territory at NBC's plant located at 0000 Xxxxxxxxxx
Xxxxxxx, Xxxxxxxxx, Xxxx 00000 (the "Facility"). Notwithstanding anything herein
to the contrary and for the avoidance of doubt, all Specifications shall be
deemed to be material.
3.2 Quality Control. Prior to each shipment of Light Sources, NBC shall
perform quality control procedures and inspections to verify that the Light
Sources to be shipped conform materially with the Specifications. Each shipment
of Light Sources shall be accompanied by a certificate of conformance describing
all current requirements of the Specifications, results of test performed
certifying that the Light Sources supplied have been manufactured, controlled
and released according to the Specifications and all relevant QS requirements at
the Facility stipulated under Section 3.1 above. Without limiting the foregoing,
if NBC's performance of the inspection and applicable testing procedures
described in Exhibit D requires [c.i.], then DUSA agrees to either (i) [c.i.] or
(ii) [c.i.]; provided that in either such case the following shall apply: NBC
shall hold such equipment at NBC's risk and shall replace the same if they are
lost, damaged or destroyed. NBC shall maintain such equipment in good condition
(subject to normal wear and tear); and such equipment shall be subject to [c.i.]
DUSA upon expiration or termination of this Agreement. Accordingly, NBC agrees
to cooperate with DUSA in the [c.i.] relating to such equipment as DUSA may deem
necessary or useful. In addition, NBC shall use such equipment solely for the
testing and inspection of Light Sources hereunder, unless otherwise agreed by
DUSA.
3.3 Acceptance.
3.3.1 General. Acceptance by DUSA of Light Sources delivered by NBC
hereunder shall be subject to inspection and applicable testing as generally
described in Exhibit D by DUSA or its designee. The parties hereto acknowledge
that the testing procedures set forth on Exhibit D as of the Effective Date
represent the procedures in effect for clinical prototype Light Sources and that
these procedures will most likely require modifications for commercial
requirements as mutually established by the parties. If on such inspection DUSA
or its designee discovers that any Light Source shipped hereunder fails to
materially conform with the Specifications or otherwise fails to materially
conform to the warranties given by NBC in Section 8.1 below, DUSA or such
designee may reject such Light Sources, which rejection shall be accomplished by
giving written notice to NBC specifying the manner in which such Light Sources
fails to meet the foregoing requirements and request a Return Material
Authorization ("RMA") from NBC. DUSA or its designee shall return the
nonconforming Light Source in accordance with NBC's reasonable instructions with
the RMA attached [c.i.]. Upon receipt of the nonconforming Light Source NBC
shall promptly [c.i.] for such Light Source. NBC shall use its best efforts to
replace the Light Sources returned by DUSA within the shortest possible time.
The replacement of nonconforming Light Sources shall have priority over the
supply of Light Sources ordered for shipment under Section 2.3 within the [c.i.]
period prior to the return or any time after the return of the nonconforming
Light Sources to NBC. The warranties given by NBC in Section 8.1 below shall
survive any failure to reject by DUSA under this Section 3.3.
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3.3.2 Settlement of Claims. In case of a disagreement between the
parties regarding whether a particular Light Source unit materially complies
with the Specifications, the claim shall be [c.i.] or [c.i.] mutually agreed
upon by the parties [c.i.], the appointment of which shall not be unreasonably
withheld or delayed by either party. The determination of [c.i.] with respect to
such dispute shall be final and binding upon the parties. The parties and [c.i.]
shall use their best efforts to [c.i.] as set forth above. The fees and expenses
of [c.i.] shall be paid by the party against which the determination is made.
3.4 Latent Defects. It is recognized that it is possible for a Light
Source to have defects which are not be discovered upon reasonable physical
inspection or testing ("Latent Defects"). As soon as either party becomes aware
of a Latent Defect in any Light Source it shall immediately notify the other
party as to the serial number(s) of the Light Source(s) involved, which at
DUSA's election, shall be deemed rejected as of the date of such notice. NBC
agrees to [c.i.] all Light Sources so involved [c.i.]. For purposes of this
Section 3.4, "defect" shall mean that a Light Source fails to conform to the
warranties given by NBC herein; however, "defect" for purposes of the foregoing,
shall [c.i.].
3.5 Presence At Facility. Upon [c.i.] given by DUSA to NBC, DUSA shall
have the right to assign a reasonable number of employees or consultants of DUSA
to inspect and audit the Facility at which Light Sources are manufactured in
order to verify NBC's compliance with QS 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, (ii) that
such employees or consultants shall observe all rules and regulations applicable
to visitors and to individuals employed at the Facility, and (iii) such
employees or consultants agree to maintain the Confidential Information of NBC
in accordance with Article 11 below.
3.6 Changes. DUSA shall have the right to modify the Specifications from
time to time. All such modifications shall be in writing and shall be signed by
an authorized representative of DUSA and NBC, and shall be effective for orders
of applicable units placed after such notice. If such modifications result in a
material change [c.i.] as shown by [c.i.], the parties shall agree upon [c.i.]
of the Light Sources hereunder; and if such modifications result in a delay in
delivery, the parties shall negotiate a reasonable extension of the affected
lead times.
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ARTICLE 4
SUPPLY OUTSIDE THE TERRITORY
From time to time as DUSA desires to secure supply of Light Sources for
sale in area(s) outside of the Territory (collectively, the "New Area(s)"), DUSA
agrees to provide notice to NBC regarding the possibility of NBC providing some
or all of such supply ("Notice"). Within [c.i.] after receiving the Notice, NBC
shall notify DUSA whether or not NBC so desires to discuss the possibility of
supplying DUSA such Light Sources for any particular New Area(s) designated by
DUSA in the Notice. If NBC desires, the parties shall negotiate in good faith
for a period of [c.i.] the terms and conditions pursuant to which NBC would
supply Light Sources to DUSA for sale for the New Area(s) so designated outside
of the Territory. If NBC 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.] period DUSA shall be free to secure one or more alternate sources for its
requirements of Light Sources for such New Area(s) outside the Territory
(including manufacturing such Light Sources itself), without any further
obligation to NBC with respect to such New Area(s) so designated.
ARTICLE 5
LICENSES
5.1 To NBC. DUSA hereby grants to NBC a license under the DUSA Technology
to manufacture the Light Sources ordered by DUSA hereunder and deliver such
Light Sources to DUSA or its designee as specified in this Agreement. The
foregoing license shall be [c.i.] with the prior written consent of DUSA.
5.2 To DUSA.
5.2.1 General. NBC hereby grants to DUSA a worldwide license under
the NBC Technology to import, use, sell, have sold and otherwise dispose of
Light Sources for purposes of the Field. The foregoing license and other
licenses under this Section 5.2 shall be [c.i.] in accordance with Section 14.5
below.
5.2.2 Manufacturing License. NBC hereby grants to DUSA, and DUSA
hereby accepts a license (the "Manufacturing License") under the NBC Technology
necessary to make, have made, use. sell, have sold and otherwise dispose of
Light Sources for use in applications within the Field. DUSA agrees not to
exercise any of its rights under the Manufacturing License, except as expressly
permitted in this Section 5.2.2 below. In any such event, NBC shall provide to
DUSA or its designee copies of all documentation within NBC's control that is
reasonably necessary for DUSA to exercise the Manufacturing License, and shall
reasonably cooperate with DUSA to establish supply of Light Sources, including
sources of components and other materials. In the event that DUSA has Light
Sources manufactured by a third party, DUSA shall obtain from such third party a
written confidentiality agreement to protect against the unauthorized use and
disclosure of NBC's Confidential Information.
5.2.2.1 Failure to Supply. If for any [c.i.] NBC fails to
supply quantities of Light Sources [c.i.] ordered in accordance with Section 2.3
above, then DUSA may manufacture or have manufactured Light Sources for sale or
other distribution in the Territory for use in applications within the Field
pursuant to the Manufacturing License. Without limiting the foregoing, if [c.i.]
or more of the [c.i.] units of Light Source delivered hereunder or [c.i.] or
more of the Light Sources supplied in [c.i.]
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during any [c.i.] period fail to conform to Specifications, the same shall be
deemed a failure to supply for purposes of this Section 5.2.2.1; provided,
however, where it can be shown that a particular Light Source failure to conform
is a result of damage during shipping rather than a failure to manufacture in
Specification, then such Light Source shall not be deemed to fail to conform to
Specifications for purposes of the foregoing and therefore shall not be
considered a failure to supply under this Section 5.2.2.1. Notwithstanding
anything in this Agreement to the contrary, if NBC's failure to supply hereunder
is as a result of a Force Majeure Event then DUSA's right to manufacture Light
Sources under this Section 5.2.2.1 shall continue until such time as NBC
provides DUSA with [c.i.] written notice of NBC's desire to resume manufacturing
and reasonably demonstrates to DUSA that it is able to adequately supply DUSA's
requirements of Light Sources and there after until (i) to the extent DUSA
contracts with a third party to supply Light Sources, for the remaining
noncancellable period of such contract, or (ii) to the extent DUSA manufactures
Light Sources itself, for a period of [c.i.] after DUSA commenced manufacturing
of such Light Sources, and thereafter, at such time as NBC [c.i.], unless DUSA
is able to redeploy such manufacturing capacity, in which event NBC shall
[c.i.], and (B) DUSA's [c.i.]. For purposes of the foregoing, DUSA's [c.i.]
shall be determined in good faith.
5.2.2.2 Outside the Territory. Except as otherwise agreed,
upon expiration of the sixty [c.i.] period as required in Article 4 above, DUSA
may manufacture or have manufactured Light Sources for sale or other
distribution for the New Area(s) so designated in DUSA's Notice for use in
applications within the Field pursuant to the Manufacturing License.
5.2.2.3 Termination. If NBC terminates this Agreement [c.i.]
or DUSA terminates this Agreement [c.i.], then DUSA may manufacture or have
manufactured Light Sources for sale or other distribution worldwide for use in
applications within the Field pursuant to the Manufacturing License.
To the extent that DUSA elects to exercise its rights under this Section 5.2
with respect to supply within the Territory, (i) DUSA shall be relieved of its
obligations under Sections 2.1, 2.2 and 2.3 and (ii) notwithstanding anything in
this Agreement to the contrary [c.i.].
ARTICLE 6
EXCLUSIVITY/COMPETITIVE PRICING
6.1 Exclusivity. Except as provided in Sections 5.2 above or 6.2 below,
DUSA agrees to purchase all of its requirements for Light Sources for the Field
for sale in the Territory from NBC. In consideration of the foregoing, NBC
agrees that during the term of this Agreement, NBC shall not supply or authorize
a third party to supply: (i) Light Sources for any purposes (other than pursuant
to this Agreement), (ii) light sources [c.i.], or (iii) light sources for
[c.i.]; otherwise, NBC shall have the right to manufacture and/or supply (or
authorize a third party to do so) any light source for any application or
purpose. If NBC supplies, or authorizes a third party to supply, such light
sources to a third party, NBC agrees to restrict in writing such third party's
use thereof to applications outside the Field.
6.2 Competitive Pricing. If after the earlier of (i) [c.i.] or (ii) DUSA's
order of [c.i.] Light Sources in accordance with Section 2.3 above and
notwithstanding anything herein to the contrary, DUSA receives a bona fide
written quote from a non-Affiliate third party for supply of Light Sources
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for sale in the Territory for a price [c.i.] the Price charged by NBC hereunder
for such Light Sources and on substantially similar or better terms and
conditions than those hereunder, then DUSA may thereafter purchase [c.i.] of its
requirements for the Territory from such third party on [c.i.] written notice to
NBC. To the extent that DUSA elects to exercise its rights under this Section
6.2, DUSA shall be relieved of its obligations under Sections 2.1, 2.2 and 2.3
with respect to [c.i.] of its original obligations. Notwithstanding the
foregoing provisions of this Section 6.2, in no event shall DUSA's obligation
order Light Sources [c.i.] of [c.i.] Light Sources for the Field. For purposes
of this Section 6.2 "Affiliate" shall mean any entity which controls, is
controlled by or is under common control with DUSA; an entity shall be regarded
as in control of another entity for purposes of the foregoing if it owns or
controls more than fifty percent (50%) of the shares of the subject entity
entitled to vote in the election of directors (or, in the case of an entity that
is not a corporation, for the election of the corresponding managing authority).
ARTICLE 7
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 Light Sources alone or with other products (collectively,
"Approvals") as DUSA deems useful or necessary. Accordingly, except as otherwise
required by law, NBC 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 Light Sources, without DUSA's prior written
permission. Notwithstanding the foregoing, NBC agrees to assist DUSA, as
requested by DUSA, in preparing, submitting and maintaining applications for
such Approvals.
7.2 Information. Without limiting the provisions of Section 7.1 above, NBC
shall promptly provide DUSA all written and other information, in NBC's
possession or control, necessary or useful for DUSA to apply for, obtain and
thereafter maintain Approvals for the Light Sources, including without
limitation information relating to [c.i.] of the Light Sources or other such
information required to be submitted to the FDA (or its foreign equivalent) in
the form of a marketing application. Except as otherwise expressly provided
herein, DUSA shall restrict the use of such information solely for the foregoing
purposes. Without limiting the foregoing and subject to Section 7.5 below, NBC
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.
7.3 Inspections. NBC 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. NBC 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 NBC to remedy conditions
cited in such inspections. In addition, NBC shall allow DUSA or its
representative to assist in the preparation for and be present at such
inspections. NBC shall provide DUSA with copies of any written inspection
reports issued by such agencies and all correspondence between NBC and the
agency related thereto, including, but not limited to, FDA Form 483, Notice of
Observation, and all correspondence relating thereto. DUSA and its regulatory
consultants, agents, marketing partners or other third parties agreed upon in
advance by NBC, under reasonable
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confidentiality requirements, shall have access, to all quality assurance and QS
audits of NBC 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 Light Sources.
7.4 DUSA Cooperation. DUSA agrees to keep NBC informed as to the status of
Approvals for Light Sources supplied hereunder.
7.5 Maintenance of Approvals. Notwithstanding anything herein to the
contrary, NBC shall not undertake any modifications to the Light Source design,
manufacturing, processing or packaging 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. NBC shall obtain and maintain all licenses, permits and
registrations other than Approvals (e.g., business licenses and the like)
necessary to manufacture the Light Sources 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 Light Source may
have caused or contributed to the death or serious injury or has malfunctioned
and that the Light Source would be likely to cause or contribute to a death or
serious injury if the malfunction were to recur. Accordingly, NBC agrees to
inform DUSA of any such information promptly after becoming aware of it so that
DUSA can comply with such reporting requirements. It is understood and agreed
that reporting to DUSA shall be within twenty-four (24) hours to enable DUSA to
comply with applicable reporting requirements.
ARTICLE 8
PRODUCT WARRANTIES/SERVICE
8.1 Product Warranties. NBC warrants and represents that:
8.1.1 Specifications. All Light Sources supplied hereunder shall
upon delivery to DUSA or such other location as specified by DUSA comply with
the Specifications and shall conform with the information shown on the
certificate of conformance provided for the particular shipment according to
Section 3.2 hereof;
8.1.2 QS. The Facility, and all Light Sources supplied hereunder
upon delivery to DUSA or such other location as specified by DUSA, meet all
applicable regulatory requirements (including applicable QS regulations) imposed
by applicable regulatory agencies with respect to any Approval;
8.1.3 Materials and Workmanship. Each Light Source shall be free
from defects in materials, workmanship and design for a period of [c.i.] after
its receipt by the end user (the "Warranty Period"). The foregoing warranty set
forth in this Section 8.1.3 [c.i.] or (ii) [c.i.].
8.1.4 Limitations. For avoidance of doubt, defects in the
manufacture of [c.i.] shall be covered by the warranties in this Section 8.1;
provided, however, that NBC [c.i.] in the [c.i.] in accordance with applicable
industry standards; and
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8.1.5 No Encumbrance. Title to all Light Sources 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, NBC
MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AS TO THE LIGHT
SOURCES, AND NBC HEREBY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. NEITHER PARTY SHALL BE
LIABLE TO THE OTHER FOR [c.i.]. EXCEPT FOR LIABILITY ARISING OUT OF 13 BELOW AND
NOTWITHSTANDING ANYTHING HEREIN TO THE CONTRARY, [c.i.].
8.3 Warranty Service. During the Warranty Period, NBC agrees, [c.i.] any
Light Source failing to meet the warranties provided hereunder. Without limiting
the foregoing, NBC shall use best efforts to provide on-site warranty repair
service to end-users within the Territory within [c.i.].
8.4 Extended Warranties. NBC may offer extended warranty service contracts
to end-users of the Light Sources supplied hereunder. Such contracts shall be on
reasonable and customary terms and conditions for services of a similar nature
and shall not be any less favorable to the end-users of the Light Sources
supplied hereunder than other end-users of other products manufactured by NBC.
It is understood and agreed that DUSA may contract with third parties to provide
extended warranty or out-of-warranty service for Light Sources or may provide
such service itself.
8.5 Out-of-Warranty Service; Spare Parts. NBC hereby undertakes to
maintain repair capability for Light Sources during the term of this Agreement
and for [c.i.] thereafter (the "Support Period") subject to its ability to
source applicable components from third parties. In accordance with the
foregoing, NBC shall, if requested by DUSA, provide out-of-warranty service on
reasonable and customary terms and conditions. In addition during the Support
Period, NBC agrees to [c.i.] spare and replacement parts [c.i.] and lead times
therefor as may be required to service and maintain Light Sources. Where there
are no such [c.i.], such spare or replacement parts shall be provided [c.i.] and
lead times, and in any event NBC's prices, terms and conditions for providing
services under this Section 8.5 shall be no less favorable to the customer than
those offered by NBC to a third party for similar services or parts.
Notwithstanding the foregoing, neither DUSA nor its customers shall have any
obligation to order any such service, or spare or replacement parts from NBC.
8.6 Epidemic Failures. In addition to and without limiting the warranties
given above, where a defect in the design [c.i.] of the Light Sources which
effects a minimum of [c.i.] of the total units of any particular Light Source
model (by SKU number) supplied hereunder (an "Epidemic Failure"), NBC shall,
[c.i.], remedy such Epidemic Failure in all units of such Light Source model
(previously supplied or to be supplied hereunder).
8.7 Recalls. In the event that DUSA is required by any regulatory agency
to recall the Light Sources or if DUSA voluntarily initiates a recall of the
Light Sources and in either case such recall is a result of a breach of any of
the warranties under Section 8.1.1 through 8.1.3 above, [c.i.]. In addition, NBC
agrees to cooperate with and assist DUSA in locating and retrieving, if
necessary, Light Sources recalled for any reason. A recall of DUSA's products
(including the Light Sources) for reasons other than those set forth in this
Section 8.7 (including reasons due to force majeure) above [c.i.].
8.8 Documentation. NBC agrees to develop and provide to DUSA documentation
describing
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routine maintenance, service and care of the Light Sources. In addition, upon
DUSA's request, NBC agrees to provide DUSA such other information and
documentation as DUSA may reasonably require in order to fulfill standard
maintenance and support requirements on reasonable and customary terms and
conditions.
ARTICLE 9
TRADEMARKS
9.1 Packaging and Labeling. The trade dress, style of packaging and the
like with respect to the Light Sources will be determined by DUSA in
consultation with NBC so as to be consistent with DUSA's standard trade dress
and style (the "Packaging Specifications"). NBC shall be responsible for
packaging and labeling the Light Sources delivered hereunder in accordance with
the Packaging Specifications and all applicable regulatory requirements.
9.2 Trademarks. Without limiting the provisions of Section 9.1 above,
packaging materials and labels for the Light Sources shall display the Blu-U
Trademark and the DUSA trade name (collectively, the "DUSA Marks"). Accordingly,
DUSA hereby grants to NBC a license to use the DUSA Marks for the term of this
Agreement for the purposes of supplying the Light Sources hereunder. The
ownership and all goodwill from the use of the DUSA Marks shall vest in and
inure to the benefit of DUSA. NBC 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 will provide and record a separate trademark
license for the DUSA Marks. NBC shall cooperate in the preparation and execution
of such documents [c.i.].
ARTICLE 10
TERM AND TERMINATION
10.1 Term. The term of this Agreement shall commence on the Effective Date
and continue in full force until the tenth anniversary of the Effective Date,
unless terminated earlier in accordance with this Article 10. This Agreement may
be extended for an additional period by mutual written agreement of NBC and DUSA
[c.i.]; provided, however, that neither NBC nor DUSA shall be obligated to
approve any such extension and shall have no liability whatsoever by reason of
any failure to agree on any such extension.
10.2 Breach. 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.
Notwithstanding the foregoing, in the event of breach by either party, the other
party's right to terminate shall be stayed if the breaching party proposes a
mutually agreeable plan to remedy such breach within [c.i.] period and remedies
such breach within [c.i.] days after being given written notice thereof. It is
understood and agreed that this Section 10.2 is subject to the provisions of
Section 14.3 below, excusing performance where performance is rendered
impossible due to a Force Majeure Event, including without limitation failure of
suppliers, in each case where such failure is beyond the reasonable control of
the nonperforming party. For avoidance of doubt, among other things a delay
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by NBC of more than [c.i.] of the delivery date of any shipment of Light Sources
ordered in accordance with Section 2.3 shall be deemed material.
10.3 Convenience. Either party may terminate this Agreement upon twelve
(12) months' prior written notice to the other party, provided, however such
notice may not be given prior to the third anniversary of the Effective Date.
10.4 Termination for Insolvency. Either party may terminate this Agreement
if the other becomes the subject of a voluntary or involuntary petition in
bankruptcy or any proceeding relating to insolvency, receivership, liquidation,
or composition or the benefit of creditors, if that petition or proceeding is
not dismissed with prejudice [c.i.] after filing.
10.5 Survival. 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. The
provisions of Sections 5.2, 8.1, 8.2, 8.3, 8.5, 8.6, 8.7 and 10.5 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 11
CONFIDENTIALITY
11.1 Confidential Information. The parties may from time to time disclose
to each other Confidential Information. "Confidential Information" shall mean
[c.i.]. 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; (iv) was subsequently lawfully disclosed to the
receiving party by a person other than the disclosing party; or (v) is developed
independently by the receiving party without use of or reliance on the
Confidential Information of the other 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
Light Sources (or products incorporating the Light Sources); 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
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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.
ARTICLE 12
REPRESENTATIONS AND WARRANTIES
12.1 NBC. NBC 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; (iii) it has not entered and will not enter into any agreements
with any third party that are inconsistent with this Agreement; (iv) NBC has not
granted any rights to any third parties to subject matter which would otherwise
be included within the definition of NBC Technology; and (v) NBC 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.
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) it has not entered and will not
enter into any agreements with any third party that are inconsistent with this
Agreement; and (iv) 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 the distribution of the Light Sources.
12.3 Disclaimer. EXCEPT AS PROVIDED IN THIS 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 13
INDEMNIFICATION
13.1 DUSA. DUSA shall indemnify, defend and hold harmless NBC, its
directors, officers, employees, agents, successors and assigns from and against
[c.i.] against any of them by a third party alleging (i) [c.i.], 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 NBC. NBC shall indemnify, defend and hold harmless DUSA, [c.i.], in
each case subject to the requirements set forth in Section 13.3 below.
Notwithstanding the foregoing, NBC shall have no obligations under this Article
13 for any liabilities, expenses or costs arising out of or relating to claims
covered under Section 13.1 above.
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;
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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, provide full information and
reasonable assistance to Indemnitor and its legal representatives with respect
to such Claims.
13.4 Insurance. Each party shall secure and maintain in effect during the
term of this Agreement and for a period of [c.i.] thereafter insurance
policy(ies) underwritten by a reputable insurance company and in a form and
having limits of at least [c.i.] in the aggregate for exposures related to the
Light Sources. Additionally, each party shall [c.i.]. Upon request by the other
party hereto, certificates of insurance evidencing the coverage required above
shall be provided to the other party.
ARTICLE 14
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.
14.2 Disputes. If NBC and DUSA, are unable to resolve any dispute between
them, either NBC or DUSA may, by written notice to the other, have such dispute
referred to [c.i.], for attempted resolution by good faith negotiations within
[c.i.] after such notice is received. Unless otherwise mutually agreed, the
negotiations between [c.i.] and at times within the period stated above offered
[c.i.] for consideration. If the parties are unable to resolve such dispute in
accordance with the aforementioned procedure or within [c.i.], either party
shall have the right to pursue any and all other remedies available to such
party.
14.3 Force Majeure. Nonperformance of any party (except for the payment of
money and acceptance by DUSA of Light Sources pursuant to an outstanding
purchase order hereunder) 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 (each a
"Force Majeure Event"). Notwithstanding the foregoing, NBC's delay of the
delivery date of any shipment of Light Sources ordered in accordance with
Section 2.3 shall not be excused for more than [c.i.] pursuant to this Section
14.3. This Section 14.3 shall not be deemed to limit DUSA's rights under Section
5.2 above.
14.4 Delays. [c.i.] for the performance of the party's obligations under
this Agreement.
14.5 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 14.5 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. Subject to the foregoing, this
Agreement shall be binding upon and inure to the benefit of the parties hereto,
their successors and assigns.
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14.6 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, 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 NBC: National Biological Corporation
0000 Xxxxxxxxxx Xxxxxxx
Xxxxxxxxx, XX 00000
Attn: President
Fax: (000) 000-0000
with a copy to: Buckingham, Xxxxxxxxx & Xxxxxxxxx, LLP
00 X. Xxxx Xxxxxx
X.X. Xxx 0000
Xxxxx, XX 00000-0000
Attn: Xxxxx Xxxxxxxxx, Esq.
Fax: (000) 000-0000
If to DUSA: DUSA Pharmaceuticals, Inc.
000 Xxxxxxxxxx Xxx.
Xxxxx 0000
Xxxxxxx, Xxxxxxx X0X 0X0
Attn:
Fax:
with a copy to: Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx
Professional Corporation
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxx, Esq.
Fax: (000) 000-0000
14.7 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.
14.8 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.
14.9 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
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construed to be a waiver of any succeeding breach of such provision or a waiver
of the provision itself.
14.10 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 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.
14.11 Independent Contractors. The relationship of DUSA and NBC
established by this Agreement is that of independent contractors. Nothing in
this Agreement shall be construed to create any other relationship between DUSA
and NBC. 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.
14.12 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. Without limiting the foregoing, the rights and obligations of the
parties under the Co-Development Agreement (except for the payment of amounts
due or to be due thereunder) with respect to the Light Source shall be deemed to
be fulfilled; provided, however, otherwise the Co-Development Agreement shall
remain in full force and effect in accordance with its terms. For avoidance of
doubt, to the extent the terms and conditions of this Agreement and the terms
and conditions of the Co-Development Agreement conflict, the terms and
conditions of this Agreement shall control. 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.
14.13 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. NATIONAL BIOLOGICAL CORPORATION
By: /s/ X. Xxxxxxx By: /s/ X.X. Xxxxxxxxx
------------------------ ----------------------------
Name: Xxxxxx X. Xxxxxxx Name: Xxxxxx X. Xxxxxxxx
---------------------- --------------------------
Title: Executive V.P. Title: President
--------------------- -------------------------
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EXHIBIT A
LIGHT SOURCE
[Attached]
[c.i.]
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EXHIBIT B
FORM OF PURCHASE ORDER
[Attached]
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DUSA Pharmaceuticals, Inc. PURCHASE
000 Xxxxxxxx Xxxxxx XXXXX
Xxxxxxx, XX 00000; USA
Phone: 000 000 0000 Fax: 000 000 0000 P.O. Number:
The following number must appear on all (Page 1 of __________________)
related correspondence, shipping papers,
and invoices:
To: Via Facsimile: Ship to:
SUBJECT TO TERMS AND CONDITIONS OF THE PURCHASE AND SUPPLY AGREEMENT BETWEEN
DUSA PHARMACEUTICALS, INC. AND NATIONAL BIOLOGICAL CORPORATION
--------------------------------------------------------------------------------
P.O. DATE REQUISITIONER TERMS
--------------------------------------------------------------------------------
DUSA Pharmaceuticals, Inc. See Below
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
QUANTITY DESCRIPTION UNIT PRICE TOTAL
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
SUBTOTAL
--------------------------------------------------------------------------------
TOTAL $
--------------------------------------------------------------------------------
1. Please send two copies of your invoice.
2. Enter this order in accordance with the prices, terms, delivery method and
all specifications listed above
3. Please notify us immediately if you are unable to ship as specified
IMPORTANT NOTATIONS:
1] Payment will be processed on a shipment of merchandise and receipt of an
appropriate invoice
2] This facsimile copy will be the only copy issued
3] Credit references are attached.
_______________________________________________
Authorized for DUSA Pharmaceuticals, Inc. Date
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EXHIBIT C
PRICE
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NATIONAL BIOLOGICAL CORPORATION
The Phototherapy Experts!
To: X. Xxxxxxx
From: X. Xxxxxxxx
Subject: Pricing - Blu-U 4170
Date: 9/24/98
Pricing for the Blu-U [c.i.] is listed below. Please note that this pricing is
at best only [c.i.], and, therefore, should not be considered [c.i.]. In
addition, pricing [c.i.] does not include [c.i.], as it is impossible to
establish pricing without a finished good. Also, several items, such as the
[c.i.] DUSA [c.i.], and the item marked [c.i.] in the DUSA provided xxxx of
materials are not quoted due to lack of sufficient information.
Finally, pricing quoted is based [c.i.] as supplied to National Biological.
Since neither DUSA or NBC is able to validate the accuracy of such xxxx until
[c.i.], errors of omission, as well as costing errors by DUSA may have occurred
which cannot at this time be accounted for, National Biological cannot therefore
rely on these [c.i.] for any purposes other than [c.i.].
The following is our estimated cost to DUSA and, subject to the language in the
P&S Agreement, may be used in the contract.
Quantity: [c.i.] [c.i.] [c.i.]
DUSA PRICE: [c.i.] [c.i.] [c.i.]
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EXHIBIT D
ACCEPTANCE TESTING
[c.i.]
23
