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Exhibit 10.17
SUPPLY AGREEMENT
Agreement effective March 15, 1997 ("Effective Date"), by and between
Nanophase Technologies Corporation, 000 Xxxxxxxx Xxxxxx, Xxxx Xxxxx, Xxxxxxxx
00000 ("NTC") and Schering-Plough HealthCare Products, Inc., 0000 Xxxxxxx
Xxxxxx, Xxxxxxx XX 00000 ("S-P"). NTC and S-P are collectively referred to as
the "Parties" and individually as a "Party."
PURPOSE
S-P desires to promote and market Nanophase (TM) Zinc Oxide ("NZO") in
consumer products marketed for footcare products including odor, wetness and
athlete's foot applications. NZO has not previously been used in these
products. S-P wants to develop a market for those products which products are
to contain NZO. In order to justify the expense and effort required to create
a market for products containing NZO S-P requires a limited period of exclusive
supply of NZO from NTC.
Accordingly, S-P and NTC hereby agree to the following terms and
conditions:
ARTICLE I
TERM, TERRITORY, AND OPTION
1.1 Territory. The territory of the Agreement will be the United States,
Canada, Mexico and Puerto Rico.
1.2 Term. The term of this Agreement shall be four (4) years commencing on
the Effective Date.
ARTICLE II
NTC'S SUPPLY RESPONSIBILITIES
2.1 Supply of NZO. NTC will exclusively supply NZO for S-P and S-P shall
exclusively purchase from NTC, all of S-P's requirements for NZO ingredients
for footcare products including odor, wetness and athlete's foot applications,
to be sold within the food, mass merchandiser and drug store classes of trade.
However, S-P's exclusivity outlined in this Section #2.1 shall be contingent
upon S-P's purchase of NZO in a quantity of at least one thousand (1,000)
kilograms ("Kg") in each three (3) month period, commencing July 1, 1997.
2.2 Exception to Exclusivity. NTC may continue to supply NZO to other
current and new customers; however, it is understood and agreed that NTC will
inform the customers, in writing, that NZO may not be used in products marketed
for use in the categories listed in 2.1 unless the use is previously known to
NTC or, if NTC's customer discloses the present use at the time of notification.
2.3 Priority. NTC agrees to give first supply priority to S-P's orders for
NZO.
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ARTICLE III
S-P'S RESPONSIBILITIES
3.1 Forecasts and Purchase Orders. S-P will provide to NTC, on a quarterly
basis, a forecast estimating S-P's or S-P's contract manufacturer's monthly
purchase requirements (the "Forecast"), along with the expected delivery dates
for the succeeding twelve (12) month period (the "Delivery Date"). S-P or S-P's
contract manufacturer will issue firm purchase orders for each delivery no
later than thirty-five (35) days prior to the requested delivery date. The
leadtime agreed upon by the parties is thirty (30) days after receipt of order.
ARTICLE IV
PRICING
4.1 Pricing. The parties hereby agree that the supply price for NZO shall
be in accordance with Exhibit A which indicates the price for various
quantities of NZO to be purchased. Terms of payment are net thirty (30) days
from date of Xxxx of Lading ship date. For purposes of this Agreement,
acceptance will occur only after S-P has completed such quality control testing
as X-X xxxxx necessary to verify the conformity of NZO to the specifications as
set forth in Exhibit B.
4.2 Basis for Product Price. The prices set forth above include all
materials, manufacturing, packaging of NZO, and such quality control measures
as required by this Agreement.
4.3 The price for NZO set forth in Section #4.1 shall be effective through
December 31, 1998 unless raw material price increases are greater than five
percent (5%) in which case price must be reviewed and negotiated by the
parties. Thereafter, the price of the NZO for a calendar year shall be subject
to annual review pursuant to a written request at intervals of not less than
twelve (12) months by the parties to take into account any increase or decrease
in NTC's labor, raw material and/or component costs directly allocable to the
manufacture of NZO. The first such review should occur three (3) months prior
to January 1, 1999. It is the intent of the parties to have all annual price
increases or decreases be effective on January 1 of each year, which will
reflect any increase or decrease in cost for the preceding calendar year. NTC
shall use reasonable efforts to obtain competitive prices for raw materials and
services from a qualified third party vendor. All calculations for overhead or
labor costs made pursuant to this Section #4.3 shall be in accordance with
NTC's accounting principles. If an agreement cannot be reached as to the price
for NZO, S-P shall have the right to terminate this Agreement.
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4.4 Maximum Price Increase. Notwithstanding the foregoing, in no event
shall the percentage of any price increase based on increases in NTC's
manufacturing costs exceed the lesser of the percentage increase in the cost of
raw materials or five percent (5%) which increase shall be substantiated by
NTC.
4.5 Records. NTC shall maintain records with respect to its costs,
obligations and performance under this Agreement. Specifically, but without
limitation, NTC shall maintain all records reasonably necessary to support
financial accounting entries and tax requirements in the Territory. All such
records shall be maintained for a period of not less than two (2) years
following termination of this Agreement or such longer period as may be
required by law, rule or regulation. Prior to the destruction of any record
available for review, notice shall be provided to S-P, and S-P shall have the
right to request and retain said record.
ARTICLE V
DELIVERY
5.1 Risk of Loss. Delivery of each order of NZO shall be F.O.B., Approved
Facility (as defined in Section 7.1 of this Agreement), freight collect (call
S-P's Transportation Department to arrange for pickup or carrier to contact) or
such other shipping point agreed upon between the parties. S-P shall arrange
via its designated common carrier transportation of the NZO to S-P's specified
plant or other designated destination. Title to and risk of loss of the NZO
shall pass to S-P at the time of delivery to the specified carrier. NTC shall
promptly xxxx S-P for all NZO tendered and invoices shall be accompanied by the
certificate of analysis for each lot of NZO delivered.
5.1(a) Identification. Each NZO ship case and pallet shall be clearly
marked in accordance with S-P's instructions.
5.1(b) All NZO shall be packaged in a manner to avoid breakage and
contamination.
5.2 Schedule. NTC shall schedule the timely manufacturing and delivery of
the NZO pursuant to S-P's purchase orders. For purposes of this Agreement, a
timely shipment shall be a shipment delivered by NTC at the F.O.B. point no
later than five (5) days prior to the dock date. The parties agree that for
purposes of delivery, time is of the essence.
5.3 Delay and Failure to Supply. Should NTC, at any time during the course
of this Agreement, have reason to believe that it will be unable to meet S-P's
requested delivery dates, NTC will promptly notify S-P in writing setting forth
the reasons for the delay. In connection therewith,
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(a) In the event NTC, for any reason (including events of excused
performance as set forth in this Agreement) has been unable to supply S-P's
binding purchase orders for NZO meeting the warranties contained in Paragraph
5.6 of this Agreement, without being able to supply ninety percent (90%) of such
binding purchase orders within an additional ten (10) days, (including any new
orders in such period), then NTC, upon written notice to S-P may establish
secondary sources of supply for the purchase requirements set forth in
Paragraph 7.4 of this Agreement.
(b) In the event S-P has reason to believe that NTC or NTC's secondary
sources for any reason (including events of excused performance as set forth
in this Agreement) will not be able to supply S-P's purchase orders for NZO
meeting the warranties contained in this Agreement, S-P may notify NTC in
writing requesting adequate assurances of future performance and that NTC will
be able to supply S-P with at least ninety percent (90%) of the purchase orders
to be delivered in accordance with this Agreement. NTC shall, within ten (10)
days, respond in writing to S-P's request for adequate assurances of future
performance stating whether NTC is or is not able to supply S-P with at least
ninety percent (90%) of the purchase orders. If NTC fails to live up to its
assurances, then S-P may also seek and/or establish a secondary supplier.
(c) In the event NTC anticipates that in the future NTC or any NTC
secondary source will be unable to supply S-P's purchase orders for NZO meeting
the warranties contained in this Agreement, with no prospect of being able to
provide ninety percent (90%) of such purchase orders within an additional
thirty (30) days, then NTC shall notify S-P in writing to that effect. Upon
such notification, S-P may, if it chooses, temporarily suspend this Agreement
and produce the NZO for its own purchase requirements as set forth in this
Agreement. At such time as NTC or a NTC secondary source is able to resume
production, with NTC exercising diligent efforts to resume production as
quickly as possible, NTC shall notify S-P in writing and continue and/or
reinstate this Agreement with NTC supplying S-P's requested requirements for
NZO for the term remaining in this Agreement.
5.4 Acceptance/Rejection. All shipments of NZO are subject to S-P's
inspection prior to acceptance. In the event that S-P believes that any batch
of NZO does not meet the previously agreed-upon NZO Specifications (as set forth
in Exhibit B), S-P shall give NTC prompt notice of its rejection of such batch,
including reasons for rejection. Upon receipt of any such notice, within
twenty (20) days following receipt of notice of rejection by S-P, NTC shall
deliver a new batch of NZO to replace the rejected batch. NTC will destroy or
dispose of the entire rejected batch in question at its sole expense.
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5.5 Overruns. Should the delivered NZO exceed the binding P. O. by more
than five (5) percent, S-P may return the excess to NTC without payment, with
all shipping costs to be paid by NTC.
5.6 Warranty. NTC warrants that at the time of delivery of the NZO at the
F.O.B. point of delivery, the NZO shall (i) have been manufactured in
accordance with GMPs and all other applicable laws, rules, regulations or
requirements of any Regulatory Authority in the Territory, (ii) meet the NZO
Specifications, (ii) shall not be adulterated or misbranded under the Federal
Food, Drug and Cosmetic Act, as amended, and (iii) be in good, usable and
merchantable condition.
SPECIFICATIONS; APPROVAL SUPPORT; REGULATORY MATTERS; RECORDS
6.1 Specifications. NTC is to supply NZO in accordance with the previously
agreed-upon specifications set forth in Exhibit B. All specifications in
Exhibit B which have not been defined as of the execution of this agreement
will be jointly determined by the parties. Should the parties be unable to
jointly determine the specifications within a reasonable time, this agreement
shall be null and void and either party may notify the other, in writing of the
immediate termination of this agreement.
6.2 Equipment. NTC shall obtain and maintain the equipment required to
fulfill its obligations under this Agreement consistent with applicable cGMPs.
6.3 Approval Support. NTC shall produce stability batches, engage in
various development activities and perform various tests as are necessary for
compliance with the United States Pharmacopeia (USP) in the Territory and to be
prepared for the pre-approval inspections by the Regulatory Authorities and
perform other activities as may be applicable.
6.4 Requlatory Assistance for Maintaining Filing. NTC shall provide S-P
with such information and assistance as S-P may require for the NZO including,
without limitation, providing S-P with all reports, authorizations,
certificates, methodologies, specifications and other documentation, excluding
formula and manufacturing processes, in the possession or under the control of
NTC relating to the pharmaceutical/technical development and manufacture of
NZO, or any component thereof needed for S-P's filings.
6.5 NTC Approvals. Except as otherwise specifically set forth herein,
NTC shall be responsible for obtaining and maintaining all approvals from the
Regulatory Authorities and any other governmental authorities necessary to
fulfill its obligations hereunder.
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6.6 Records and Inspection. NTC shall maintain all records necessary to
comply with all applicable laws, rules and regulations in the Territory of sale
of the NZO. Specifically, but without limitation, NTC shall maintain all
records and samples reasonably necessary to support GMPs and other regulatory
requirements in the Territory. All records shall be available for inspection,
audit and copying by S-P and its representatives and agents upon reasonable
request during normal business hours. All such records shall be maintained for
a period as may be required by law, rule or regulation and all records relating
to the manufacture, stability and quality control of all NZO shall be retained
for a period of not less than seven (7) years from the date of expiration of
each batch of each NZO to which said records pertain. Prior to destruction of
any record, NTC shall give notice to S-P, which shall have the right to request
and retain such record.
6.7 Retention of Samples. NTC shall retain a sufficient quantity of NZO to
perform at least full duplicate quality control testing. Retained repository
samples shall be maintained in a suitable storage facility for a period of not
less than seven (7) years after the date of manufacture of each batch of the
NZO. All such samples shall be available for inspection and testing by S-P upon
reasonable notice.
6.8 Complaints or Adverse Experiences. NTC agrees to notify S-P within
twenty-four (24) hours of the receipt of any complaints and reports of adverse
drug events ("AEs") associated with the NZO. S-P shall have primary
responsibility for fielding, investigating and responding to all NZO complaints
and AEs from the Territory. S-P shall interface with NTC's Pharmaceutical
Quality Assurance Department, as appropriate and needed, to investigate such
complaints or AEs. The parties shall each report monthly on the resolution of
complaints. NTC shall cooperate with S-P in investigating and responding to NZO
complaints and NTC will assume all responsibility for investigating and
responding to complaints or AEs which are determined to result from the
Manufacturing of the NZO and shall report to S-P on a monthly basis. In the
event the parties' expenses to undertake the activities described in this
paragraph result in, or may result in, extraordinary costs of investigation or
testing (other than for those expenses which are solely manufacturing
problems), S-P and NTC agree to negotiate whether to incur, and how to
allocate, such costs.
6.9 Debarment. NTC represents and warrants that it will not use in any
capacity, in connection with any manufacturing or other services to be
performed under this Agreement, any individual who has been debarred pursuant
to the Federal Food, Drug and Cosmetic Act. NTC agrees to immediately inform
S-P in writing if any person who is performing services hereunder is debarred
or if any action, suit, claim, investigation or legal or administrative
proceeding is pending, or, to the best of NTC's knowledge, is threatened,
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relating to the debarment of NTC or any person performing Manufacturing or
other services hereunder.
ARTICLE VII
QUALITY CONTROL
7.1 Facility Compliance and Related Matters. (a) NTC covenants that they
will provide approved designated site(s) for the manufacture of the NZO
("Approved Facility/ies") and such Approved Facility/ies" shall i) include all
of NTC's equipment, machinery and facilities at those locations which have been
specifically approved as a GMP manufacturing facility in the manufacture and
storage of NZO, and (ii) the Approved Facility for NZO shall be in compliance
with all applicable laws, rules and regulations at all times during the term of
this Agreement. NTC shall be responsible for all costs and expenses related to
the compliance of the Approved Facility with GMP's and such laws, rules and
regulations related to the manufacture of the NZO in accordance with the
Specifications. NZO shall be manufactured at the Approved Facility and the
location thereof shall not be changed without S-P's written consent.
(b) Exhibit C attached hereto describes all products which are
manufactured on machinery or equipment used to manufacture NZO. NTC shall
notify S-P in writing of any potential additional products to Exhibit C. If S-P
identifies a potential problem of cross-contamination arising from the products
listed on Exhibit C or any additions thereto, the parties will meet to address
the cross-contamination issue. At S-P's request, NTC shall provide S-P with all
information and written procedures necessary to examine and resolve the
cross-contamination issue. Until the parties mutually satisfactorily resolve
the cross-contamination issue, NTC shall not manufacture products on machinery
or equipment used to manufacture the NZOs which S-P believes could cause
cross-contamination for the NZOs. [Include, if applicable.]
7.2 Specifications Amendments. The NZO Specifications shall be amended or
supplemented to comply with GMPs and may be amended or supplemented (including,
without limitation, for the purpose of incorporating improvements) from time to
time upon the written request of S-P. In the event such amendment requires
additional actual cost to NTC for the manufacture of the NZO, S-P and NTC shall
agree on the additional compensation therefore.
7.3 Quality Control Program. NTC shall maintain a quality control program
consistent with GMP, as required by the Regulatory Authorities in the
Territory, which program, as amended or supplemented, shall be provided to S-P
from time to time.
7.4 Approval for Manufacturing Changes; Third Party
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Manufacturing. NTC agrees that no changes will be made to any materials,
suppliers, equipment or methods of production or testing for the NZO without
S-P's prior written approval. Upon written approval of S-P, NTC may then make
those changes in manufacturing procedures required by GMP or other applicable
law, rule or regulation or Regulatory Authority. Under no circumstances will
NTC contract out all or any part of the Manufacturing to a third party without
prior written approval from S-P.
7.5 Standards. All NZO supplied hereunder shall be manufactured in
accordance with GMPs, and all other applicable national, state and local laws,
rules and regulations in effect at the time of manufacture.
7.6 Production Samples. NTC shall provide S-P's Quality Control Department
with production samples of the NZO and copies of completed batch records upon
request, and will provide a written certificate of analysis with each lot of
NZO.
7.7 Batch Failure. NTC agrees to notify S-P within two (2) working days of
discovery of any batch failure which could result in NTC's inability to meet
S-P's requested delivery dates, or of learning of any failure of any batch of
NZO to meet standards set forth in the S-P Manufacturing Know-how.
7.8 Notification of Inspections. NTC agrees to notify S-P immediately of
any inquiries, notifications, or inspection activity by any Regulatory
Authority in regard to the NZO. NTC shall provide a reasonable description to
S-P of any such governmental inquiries, notifications or inspections promptly
after such visit or inquiry, but in less than two (2) calendar days, NTC shall
furnish to S-P, (a) within two (2) days after receipt, any report or
correspondence issued by the Regulatory Authority in connection with such visit
or inquiry, including but not limited to, any FDA Form 483 Establishment
Inspection Reports, warning letters and (b) prior to responding to a Regulatory
Authority, copies of any and all proposed responses or explanations relating to
items set forth above, in each case purged only of trade secrets of NTC that
are unrelated to the obligations under this Agreement or are unrelated to the
NZO.
7.9 Inspection by S-P. S-P shall have the right during normal business
hours (including, without limitation, during production or after normal business
hours if reasonably requested and in connection with a production run that
commenced during the normal business hours) and with reasonable advance notice
to visit NTC's Approved Facility for the purpose of observing the
manufacturing, packaging, testing, and warehousing of the NZO, and to inspect
for compliance with GMPs and other applicable regulatory requirements. S-P
shall also have the right to be present at an inspection referenced in Section
8.8 above.
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7.10 Environmental and Other Laws and Regulations. In carrying out its
obligations under this Agreement, NTC shall comply with all applicable
environmental and health and safety laws, regulations, ordinances, guidelines
and policies (current or as amended or added) (hereinafter "Laws"), and shall
be solely responsible for determining how to carry out these obligations.
Notwithstanding any other provision in this Agreement to the contrary, nothing
provided to NTC by S-P, by way of materials, specifications, processing
information or otherwise, is meant to diminish this as NTC's sole
responsibility. NTC also represents and warrants that it has the appropriate
skills, personnel, equipment, permits, approvals or the like necessary to
perform its services or provide materials under this Agreement in compliance
with all applicable Laws. NTC shall immediately notify S-P, in writing, or any
circumstances, including the receipt of any notice, warning, citation, finding,
report or service of process or the occurrence of any release, spill, upset, or
discharge, relating to NTC's compliance with this Section 7.10 or which may
impose environmental liability upon NTC. NTC's noncompliance with this Section
7.10 is considered a material breach of this Agreement. S-P reserves the right
to conduct an environmental inspection of NTC's facility or facilities, during
normal business hours and with reasonable advance notice, for the purpose of
determining compliance with this Section 7.10. S-P will share the results of
any environmental inspection with NTC. Such inspection, if it occurs, does not
relieve NTC of its sole obligation to comply with all applicable Laws and does
not constitute a waiver of any right otherwise available to S-P.
7.11 Inspection and Acceptance. S-P will inspect the NZO and conduct any
quality control testing it deems necessary to verify conformity to raw material
specifications as referenced in this Agreement. Product rejected by S-P will be
returned to NTC, at NTC's cost, for credit & replacement.
ARTICLE VIII
RESERVED
ARTICLE IX
RENEWAL AND TERMINATION
9.1 Renewal of the Agreement. S-P may on sixty (60) days written notice to
NTC notify S-P's intentions to renegotiate extending the term of this Agreement
listed in Paragraph 1.2(a). NTC will renegotiate renewal in good faith upon
mutual agreement.
9.2 Termination by Non-Renewal. Either party may terminate this Agreement
by giving the other party written notice of termination at least ninety (90)
days prior to the end of the
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initial term or any renewal period.
9.3 Termination by S-P. S-P shall have the right to terminate this
Agreement if:
9.3.1 there is a change in control of NTC. For purposes of this provision,
a "change in control" shall mean the acquisition of fifty percent (50%) or more
of the assets or outstanding common stock or other equity interest of NTC by a
non-affiliated third party. NTC shall notify S-P in writing at least sixty (60)
days prior to any "change in control". S-P shall notify NTC in writing within
thirty (30) days of such notification whether or not S-P elects to terminate
this Agreement. S-P warrants that it will make a reasonable effort to continue
this Agreement with any controlling parties and will not arbitrarily terminate
it under this paragraph 9.3.1.
9.3.2 NTC files a petition in bankruptcy, or enters into an arrangement
with its creditors, or applies for or consents to the appointment of a receiver
or trustee, or makes an assignment for the benefit of creditors, or suffers or
permits the entry of an order adjudicating it to be bankrupt or insolvent. In
the event this Agreement is terminated under Section 9.3.2, all rights and
licenses granted under this Agreement by NTC to S-P are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses
of rights to "intellectual property" as defined under Section 101(52) of the
Bankruptcy Code. The parties agree that S-P, as a licensee of such rights under
this Agreement, shall retain and may fully exercise all of its rights and
elections under the Bankruptcy Code. The parties further agree that, in the
event of the commencement of a bankruptcy proceeding by or against NTC under
the Bankruptcy Code, S-P shall be entitled to a complete duplicate of (or
complete access to, as appropriate) any such intellectual property and all
embodiments of such intellectual property upon written request therefore by
S-P. Such intellectual property and all embodiments thereof shall be promptly
delivered to S-P (i) upon any such commencement of a bankruptcy proceeding upon
written request therefore by S-P, unless NTC elects to continue to perform all
of its obligations under this Agreement or (ii) if not delivered under (i)
above, upon the rejection of this Agreement by or on behalf of NTC upon written
request therefore by S-P.
9.4 Termination for Material Default. Upon default by a party in the
performance of any material obligation in this Agreement which results in
significant harm to the non-defaulting party, the non-defaulting party may give
notice in writing to the party in default and the defaulting party shall have
sixty (60) days thereafter to cure the default. Except as qualified in the
last sentence of this paragraph, if the defaulting party does not cure or
institute measures to substantially cure such default within sixty (60) days
and diligently complete the cure within an
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additional sixty (60) days, the non-defaulting party may terminate this
Agreement by providing notice of intent to terminate which shall take effect
ten (10) days following the receipt by the defaulting party of such notice.
Termination under this Article shall not relieve either party of any obligation
existing upon the date of termination or relieve the defaulting party from
liability for breach of this Agreement.
9.5 Effect of Termination. Expiration or termination of the Agreement
shall not relieve the parties of any obligation accruing prior of such
expiration or termination, and the provisions of Sections 6.5 and Articles 12,
13 and 14, shall survive the expiration of the Agreement. Any expiration or
early termination of this Agreement shall be without prejudice to the rights of
either party against the other accrued or accruing under this Agreement prior
to termination.
9.6 No Waiver. The failure of either party to terminate this Agreement by
reason of the breach of any of its provisions by the other party shall not be
construed as a waiver of the rights or remedies available for any subsequent
breach of the terms and provisions of this Agreement.
ARTICLE X
FORCE MAJEURE; INABILITY TO SUPPLY
10.1 Force Majeure. Neither party shall be responsible for any failure to
comply with the terms of this Agreement where such failure is due to force
majeure, which shall include, without limitation, fire, flood, explosion,
strike, labor disputes, labor shortages, picketing, lockout, transportation
embargo or failures or delays in transportation, strikes or labor disputes
affecting supplies, or acts of God, civil riot or insurrection, acts of the
government, or judicial action. Specifically excluded from this definition are
those acts of any governmental agency, or judicial action, which could have
been avoided by compliance with such laws or regulations, publicly available
and reasonably expected to be known by either party. Upon the cessation of any
cause operating to excuse performance of either party under this Section 9.1,
this Agreement shall continue in full force and effect unless or until
otherwise terminated pursuant to this Agreement and each party shall endeavor
to resume its performance hereunder as quickly as possible if such performance
is delayed or interrupted by reason of any cause set forth herein. If one or
more of said causes set forth herein is asserted by either party as a basis of
that party's nonperformance, the other party shall have the right to terminate
this Agreement forthwith by giving written notice to that effect prior to the
resumption of performance.
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ARTICLE XI
COMPLIANCE WITH LAWS
All NZO manufactured by NTC pursuant to this Agreement shall be subject to
all applicable Federal, State and local laws, including, but not limited to, the
Fair Labor Standards Act of 1938, as amended and, unless NTC is exempted, the
President's Executive Order No. 11246, Section 202, relating to equal
employment opportunities and all subsequent additions or amendments thereto,
and the Immigration Reform Act of 1986.
ARTICLE XII
INDEMNIFICATION AND INSURANCE
12.1 NTC's Indemnification Obligation. NTC agrees to indemnify and hold
S-P, its agents and employees harmless from and against all claims, liabilities
(including product liability), costs, damages, losses, judgments for damages or
expenses (including reasonable attorney's fees) caused by, arising out of, or
resulting from i) NTC's negligent acts and/or omissions relating to the
manufacture of NZO and ii) NTC's performance of its obligations hereunder
(including any environmental contamination or release of hazardous substance,
or hazardous wastes to the environment caused by NTC, its Approved Facilities,
its employees, agents or contractors), its failure to comply with this
Agreement, or any laws and regulations applicable to such performance.
12.2 S-P's Indemnification Obligation. S-P agrees to indemnify and hold
NTC, its agents and employees harmless from and against all claims, liabilities,
costs, damages, losses, judgments for damages or expenses (including reasonable
attorneys' fees) caused by, arising out of, or resulting from S-P's negligent
acts and/or omissions relating to the marketing, distribution and sale of the
NZO.
12.3 Notice of Suit. The indemnified party agrees to give the indemnifying
party prompt notice in writing of the institution of any suit, including any
suit or claim asserted or made by any governmental authority having
jurisdiction, and the indemnified party agrees to permit the indemnifying party
to have control and conduct of the defense of such suit, and give the
indemnifying party all needed information in the indemnified parties possession
and all authority and assistance necessary to enable the indemnifying party to
carry on the defense of such suit and any appeal from a judgment or decree
rendered therein.
12.4 Insurance. NTC represents and warrants that during the term of this
Agreement and any renewals or extensions, it shall maintain the types and
amounts of insurance set forth below:
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(i) Commercial General Liability Insurance, including contractual liability
coverage of all of NTC's obligations under this Agreement and Products
Liability/Completed Operations coverage with a minimum limit of one (1) million
dollars ($1,000,000) each claim.
(ii) NTC will provide a certificate of insurance for their current
coverage. NTC shall provide thirty (30) days' written notice of cancellation
or material change in the policy to S-P, if possible.
12.5 Prior Written Consent. Neither NTC nor S-P shall be responsible or
bound by any compromise of claims, demand, judgments or causes of action made
without its prior written consent.
12.6 Notice of Claims. Each party agrees to give the other prompt written
notice of any claims made, including any claims asserted or made by any
governmental authority having jurisdiction, for which the other might be liable
under the foregoing indemnification together with the opportunity to defend,
negotiate and settle such claims.
ARTICLE XIII
TRADE NAMES AND TRADEMARKS
13.1 S-P and NTC hereby acknowledge that neither party has, and shall not
acquire, any interest in any of the other party's trademarks, tradenames,
tradedress or copyrights appearing on the labels or packaging materials for the
NZO unless otherwise expressly agreed.
ARTICLE XIV
CONFIDENTIALITY
14.1 Both NTC and S-P recognize that know-how of a party disclosed to the
other party pursuant to this Agreement or developed as a result of
Manufacturing NZO carried out pursuant to this Agreement, is of proprietary
value and is to be considered highly confidential ("Proprietary Information").
NTC and S-P shall use only in accordance with this Agreement and shall not
disclose to any third party any Proprietary Information, without the prior
written consent of the other party. The foregoing obligations shall survive
the expiration or termination of this Agreement for a period of twenty (20)
years. These obligations shall not apply to Proprietary Information that:
(a) is known by the receiving party at the time of its receipt, and not
through a prior disclosure by the disclosing party, as documented by business
records;
13
14
(b) is at the time of disclosure or thereafter becomes published or
otherwise part of the public domain without breach of this Agreement by the
receiving party;
(c) is subsequently disclosed to the receiving party by a third party who
has the right to make such disclosure;
(d) is developed by the receiving party independently of Proprietary
Information or other information received from the disclosing party and such
independent development can be properly demonstrated by the receiving party;
(e) is disclosed to governmental or other regulatory agencies in order to
obtain patents or to gain approval to conduct clinical trials or to market NZO,
but such disclosure may be only to the extent reasonably necessary to obtain
such patents or authorizations;
(f) is necessary to be disclosed to sublicensees, agents, consultants,
Affiliates and/or other third parties for the research and development,
manufacturing and/or marketing of NZO (or for such parties to determine their
interest in performing such activities) in accordance with this Agreement on
the condition that such third parties agree to be bound by the confidentiality
obligations contained in this Agreement, provided that the term of
confidentiality for such third parties shall be no less than twenty (20) years;
or
(g) is required to be disclosed by law or court order, provided that
notice is promptly delivered to the other party in order to provide an
opportunity to seek a protective order or other similar order with respect to
such Proprietary Information and thereafter discloses only the minimum
information required to be disclosed in order to comply with the request,
whether or not a protective order or other similar order is obtained by the
other party.
Nothing herein shall be interpreted to prohibit S-P from publishing the
results of its studies in accordance with industry practices.
14.2 No Publicity. A party may not use the name of the other party in any
publicity or advertising and, may not issue a press release or otherwise
publicize or disclose any information related to this Agreement or the terms or
conditions hereof, without the prior written consent of the other party. The
parties shall agree on a form of initial press release that may be used by
either party to describe this Agreement. Nothing in the foregoing, however,
shall prohibit a party from making such disclosures to the extent deemed
necessary under applicable federal or state securities laws or any rule or
regulation of any nationally recognized securities exchange; in such event,
however, the disclosing party shall use
14
15
good faith efforts to consult with the other party prior to such disclosure
and, where applicable, shall request confidential treatment to the extent
available.
ARTICLE XV
NOTICES
15.1 Notices. Each notice required or permitted to be given or sent under
this Agreement shall be given by facsimile transmission (with confirmation
copy by registered first-class mail) or by registered or overnight courier
(return receipt requested), to the parties at the addresses and facsimile
numbers indicated below.
If to NTC, to:
Nanophase Technologies Corporation
000 Xxxxxxxx Xxxxxx
Xxxx Xxxxx, XX 00000
Attention: X. X. Xxxxx
Facsimile No.: 630/323-1221
If to S-P, to:
Schering-Plough HealthCare Products, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: Xxxx Xxxx
Facsimile No.: (000) 000-0000
with copies to:
Schering-Plough Corporation
0000 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, XX 00000
Attention: Xxxxxxx Xxxxxxxxxxx
Legal Director
Facsimile No.: (000) 000-0000
Any such notice shall be deemed to have been received on the earlier of the
date actually received and the date five (5) days after the same was posted.
Either party may change its address or its facsimile number by giving the other
party written notice, delivered in accordance with this Section.
15
16
ARTICLE XVI
ASSIGNMENT
16.1. Neither this Agreement nor any or all of the rights and obligations
of a party hereunder shall be assigned, delegated, sold, transferred,
sublicensed (except as otherwise provided herein) or otherwise disposed of, by
operation of law or otherwise, to any third party other than an Affiliate of
such party, without the prior written consent of the other party, and any
attempted assignment, delegation, sale, transfer, sublicense or other
disposition, by operation of law or otherwise, of this Agreement or of any
rights or obligations hereunder contrary to this Section #16.1 shall be a
material breach of this Agreement by the attempting party, and shall be void
and without force or effect; provided, however, S-P and NTC may, with consent
and said consent will not be unreasonably withheld, assign the Agreement and
its rights and obligations hereunder to an Affiliate or in connection with the
transfer or sale of all or substantially all of its assets related to the
division or the subject business, or in the event of its merger or
consolidation or change in control or similar transaction. This Agreement shall
be binding upon, and inure to the benefit of, each party, its Affiliates, and
its permitted successors and assigns. Each party shall be responsible for the
compliance by its Affiliates with the terms and conditions of this Agreement.
ARTICLE XVII
GOVERNING LAW
17.1 This Agreement shall be governed, interpreted and construed in
accordance with the laws of the State of Tennessee, without giving effect to
conflict of law principles.
ARTICLE XVIII
MISCELLANEOUS
18.1 Waiver. A waiver of any breach or any provision of this Agreement
shall not be construed as a continuing waiver of other breaches of the same or
other provisions of this Agreement.
18.2 Independent Relationship. Nothing herein contained shall be deemed to
create an employment, agency, joint venture or partnership relationship between
the parties hereto or any of their agents or employees, or any other legal
arrangement that would impose liability upon one party for the act or failure
to act of the other party. Neither party shall have any power to enter into any
contracts or commitments or to incur any liabilities in the name of, or on
behalf of, the other party, or to bind the other party in any respect
whatsoever.
16
17
18.3 Export Control. This Agreement is made subject to any restrictions
concerning the export of products or technical information from the United
States of America which may be imposed upon or related to NTC or S-P from time
to time by the government of the United States of America. Furthermore, S-P
agrees that it will not export, directly or indirectly, any technical
information acquired from NTC under this Agreement or any products using such
technical information to any country for which the United States government or
any agency thereof at the time of export requires an export license or other
governmental approval, without first obtaining the written consent to do so
from the Department of Commerce or other agency of the United States government
when required by an applicable statute or regulation.
18.4 Entire Agreement; Amendment. This Agreement, including the Exhibits
and Schedules hereto, sets forth the complete, final and exclusive agreement and
all the covenants, promises, agreements, warranties, representations,
conditions and understandings between the parties hereto and supersedes and
terminates all prior agreements and understandings between the parties. There
are no covenants, promises, agreements, warranties, representations, conditions
or understandings, either oral or written, between the parties other than as
are set forth herein and therein. No subsequent alteration, amendment, change
or addition to this Agreement shall be binding upon the parties unless reduced
to writing and signed by an authorized officer of each party.
18.5 Severability. If any provision of this Agreement is declared invalid
or unenforceable by a court having competent jurisdiction, it is mutually agreed
that this Agreement shall endure except for the part declared invalid or
unenforceable by order of such court. The parties shall consult and use their
best efforts to agree upon a valid and enforceable provision which shall be a
reasonable substitute for such invalid or unenforceable provision in light of
the intent of this Agreement.
18.6 Counterparts. This Agreement shall become binding when any one or more
counterparts hereof, individually or taken together, shall bear the signatures
of each of the parties hereto. This Agreement may be executed in any number of
counterparts, each of which shall be an original as against either party whose
signature appears thereon, but all of which taken together shall constitute but
one and the same instrument.
17
18
IN WITNESS WHEREOF, S-P and NTC have caused this Agreement to be executed
by their duly authorized officers as of the day and year first above written.
SCHERING-PLOUGH HEALTHCARE NANOPHASE TECHNOLOGIES
PRODUCTS, INC. CORPORATION
By: /s/ Xxxx X. Xxxxxxx By: /s/ X. X. Xxxxx
---------------------- ----------------------
X. X. Xxxxx, Ph.D.
Vice President,
Title: Senior Vice President Marketing
-----------------------
Scientific and Regulatory
Affairs
18
19
EXHIBIT A
Pricing - NanoGard ZNO USP
Pricing: $18.81/kg for 3,000-10,000 kg annual
quantities
$22.00/kg for less than 3,000 kg annual
quantities
Lot Size: 550 kg +/- 10%
1,210 lb +/- 10%
20
EXHIBIT B
[SCHERING-PLOUGH LOGO]
To: Xxxxx Xxxxx
From: Xxxx Xxxxxxx
Date: October 15, 1996
Subject: PROPOSED SPECIFICATIONS FOR NEW RAW MATERIAL
--------------------------------------------------------------------------------
ITEM: Zinc Oxide NanoGard
ITEM NO: 04727-40
Attached are the Propsed Specifications for the above raw material. Also
included are copies of the following.
X Certificate of Analysis (COA)
-----
X Material Safety Data Sheet (MSDS)
-----
X Vendor Specifications
-----
USP methods are used for sample analysis with the following additional
comments.
Loss on Ignition: Vendor specifications are (less than or equal to) 1.5%
which is different from the USP specifications of (less than or equal to)
1.0%.
Average Particle Size is taken from the Certificate of Analysis.
Please contact me if you need any additional information.
Compiled by: /s/ [Signature] 10/15/96
---------------------------------------------------------------
Analytical Research Date
Received by: /s/ [Signature] 10/15/96
---------------------------------------------------------------
Quality Standards Date
c: X. Xxxxx (Specifications and MSDS)
X. Xxxxxx (Specifications and MSDS)
X. Xxxxxxxx (MSDS)
21
SCHERING-PLOUGH HEALTHCARE PRODUCTS, MEMPHIS OPERATIONS
QUALITY CONTROL PROPOSED TESTING STANDARD
PAGE 1 OF 1
-------------------------------------------------------------------------------
ITEM: ITEM NO:
ZINC OXIDE NANOGARD 04727-40
-------------------------------------------------------------------------------
T.S. NUMBER: SUPERSEDES: EFFECTIVE DATE:
RM-04727 NEW
-------------------------------------------------------------------------------
COMPLILED BY: APPROVED BY:
-------------------------------------------------------------------------------
===============================================================================
TEST SPECIFICATION REFERENCE
===============================================================================
* Description Must pass USP. USP 23, p. 2115
-------------------------------------------------------------------------------
* Identification Must Pass USP. USP 23, p. 1644
-------------------------------------------------------------------------------
$ Average Particle Limits: 23 - 43 nm. Vendor Spec
Size
-------------------------------------------------------------------------------
* Loss on Ignition Maximum: 1.5% (w/w) USP 23, p. 1644
and Vendor Spec
-------------------------------------------------------------------------------
* Assay Limits: 99.0 - 100.5% (w/w) USP 23, p. 1644
(Calculated on the ignited
basis.)
===============================================================================
$ Certificate of Analysis Result Required
* Retest Interval Test
Retest Interval: 12 Months
22
[NANOPHASE LETTERHEAD]
--------------------------------------------------------------------------------
CERTIFICATE OF ANALYSIS
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
TRADE NAME: NanoGard(TM) Zinc oxide
PRODUCT NAME: Zinc oxide
LOT NUMBER: ZM60923-03
DATE: 9/25/96
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
2
SPECIFIC SUFRACE AREA: 32 m /g
(Test method gas adsorption)
AVERAGE PARTICLE SIZE 33 nm
(Deduced by SSA measurement)
DENSITY: 5.6 g/cc
(Test method gas pycnometry)
Material Certified By: /s/ [Signature]
--------------------------------------------------------------------------------
Quality Assurance
SAFETY PRECAUTIONS: Please see the MSDS before handling the material.
--------------------------------------------------------------------------------
23
[NANOPHASE LOGO]
--------------------------------------------------------------------------------
ZINC OXIDE POWDER
-------------------------------------------------------------------------------------------------
Test Specification Test method
-------------------------------------------------------------------------------------------------
Specific Surface Area 2
25-45 (m /g) Gas Adsorption 5-point BET (QA-01-518)
-------------------------------------------------------------------------------------------------
Particle Size (Avg) 43-23 nm calculated
calculated from BET
99.9% of total distribution PS (nm) = [6/(density x BET)] x 1000
-------------------------------------------------------------------------------------------------
Density 5.6+0.2 g/cc Helium Gas Pycnometry (QA-01-525)
-
-------------------------------------------------------------------------------------------------
9-26-96
24
[NANOPHASE LOGO]
-------------------------------------------------------------------------------
ZINC OXIDE
-------------------------------------------------------------------------------
Test Spec. Test method
-------------------------------------------------------------------------------
Identification A Passes USP USP-23 (ZnO official monograph)
-------------------------------------------------------------------------------
Identification B Passes USP USP-23 (ZnO official monograph)
-------------------------------------------------------------------------------
Carbonate, & clarity & color Passes USP USP-23 (ZnO official monograph)
-------------------------------------------------------------------------------
Alkalinity Passes USP USP-23 (ZnO official monograph)
-------------------------------------------------------------------------------
Iron or other metals Passes USP USP-23 (ZnO official monograph)
-------------------------------------------------------------------------------
Loss on Ignition <1.5% USP-23 (ZnO official monograph)
-
-------------------------------------------------------------------------------
Assay 99.0-100.5 USP-23 (ZnO official monograph)
-------------------------------------------------------------------------------
Color DE < 20 Spectrophotometry
-
-------------------------------------------------------------------------------
2
Specific Surface Area 25-45 (m /g) Gas Adsorption Multi-point BET
-------------------------------------------------------------------------------
TRACE IMPURITIES:
-------------------------------------------------------------------------------
As <2 PPM ICP
-
-------------------------------------------------------------------------------
Cd <15 PPM ICP
-
-------------------------------------------------------------------------------
Pb <20 PPM ICP
-
-------------------------------------------------------------------------------
Hg <1 PPM ICP
-
-------------------------------------------------------------------------------
25
[NANOPHASE LOGO] PRODUCT SPECIFICATIONS
-------------------------------------------------------------------------------
NANOGARD(TM) ZINC OXIDE (ZnO)
DESCRIPTION
NanoGard(TM) Zinc oxide is a white to off white colored, loosely agglomerated
ZnO with a spherical morphology. NanoGard(TM) zinc oxide is manufactured by a
physical vapor synthesis method, resulting in highly reproducible,
contaminant-free surfaces, and a minimum purity of 99.95%. Residual impurity
levels meet USP, CFR, and JP standards, making NanoGard(TM) Zinc oxide ideally
suited for OTC and cosmetic applications.
PHYSICAL PROPERTIES
2 2
Typical average surface area (BET) 35 m /g+ 10 m /g
-
Typical average particle size 31 nm
True density 5.6 g/cc
ASSAY
Before surface treatment 99.9+%
TRACE ELEMENTS (TYPICAL)
As <2 PPM
Hg <1 PPM
Pb <20 PPM
Cd <15 PPM
KEY FEATURES AND BENEFITS
- Spherical, free flowing powders facilitate preparation of
agglomerate-free dispersions when particles are properly coated
- pH-stable aqueous dispersions available.
- NanoGard(TM) Zinc oxide can be dispersed in a wide variety of cosmetic
vehicles to meet customer requirements
- Transparent to visible light when properly dispersed
- UV-attenuating properties
26
NANOGARD(TM) ZINC OXIDE
Page 1 of 4
MATERIAL SAFETY DATA SHEET Revision Date: August 19, 1996
NANOPHASE TECHNOLOGIES CORPORATION
000 Xxxxxxxx Xxxxxx
Xxxx Xxxxx, XX 00000
Phone: (000) 000-0000, FAX: (000) 000-0000
INFOTRAC emergency phone number: (000) 000-0000
-------------------------------------------------------------------------------
SECTION 1 - PRODUCT IDENTIFICATION
-------------------------------------------------------------------------------
PRODUCT NAMES(S): NanoGard(TM) Zinc oxide
SYNONYMS: Zinc oxide fume, zinc white, zincite, zincoid, snow white, protox
type, ozide, ozio, pasco, permanent white, philosopher's wool, emanay zinc
oxide, emar, flowers of zinc, calamine, Chinese white, pigment white
CHEMICAL FAMILY: Metal oxide
CAS NUMBER: 1314-13-2
MOLECULAR FORMULA: ZnO
-------------------------------------------------------------------------------
SECTION 2 - INGREDIENTS
-------------------------------------------------------------------------------
PRINCIPAL HAZARDOUS COMPONENTS CAS NO. % PEL TLV
------------------------------ ------- - --- ---
3 3
Zinc oxide 1314-13-2 100 15mg/m 5 mg/m
-------------------------------------------------------------------------------
SECTION 3 - PHYSICAL DATA
-------------------------------------------------------------------------------
BOILING POINT: Not known
% VOLATILES: N/A
SOLUBILITY IN WATER: 0.00016 gms per 100 cc
SPECIFIC GRAVITY (H O=1): 5.60
2
FREEZING/MELTING POINT: 1975 degrees C
EVAPORATION RATE (BUTYL ACETATE=1): N/A
VAPOR DENSITY (AIR=1): N/A
VAPOR PRESSURE: N/A
APPEARANCE AND ODOR: White powder, odorless
OTHER: No data
-------------------------------------------------------------------------------
SECTION 4 - FIRE AND EXPLOSION HAZARD DATA
-------------------------------------------------------------------------------
FLASH POINT: N/A Method: N/A
FLAMMABLE LIMITS IN AIR, % BY VOLUME: N/A Lower: N/A Upper: N/A
AUTO IGNITION TEMPERATURE: N/A
EXTINGUISHING MEDIA: Will not burn
27
NANOGARD(TM) ZINC OXIDE
Page 2 of 4
-------------------------------------------------------------------------------
SECTION 4 - FIRE AND EXPLOSION HAZARD DATA (CONT.)
-------------------------------------------------------------------------------
SPECIAL FIRE FIGHTING PROCEDURES: = No special fire procedures needed.
= Use normal procedures which include
wearing NIOSH/MSHA approved self-contained
breathing apparatus, flame and chemical
resistant clothing, hats, boots and
gloves.
= If without risk, remove material from fire
area. Cool metal and plastic containers
with water from maximum distance.
= Avoid any actions which cause dusting if
possible, to prevent contact with skin and
eyes. If unavoidable wear self-contained
breathing apparatus.
UNUSUAL FIRE AND EXPLOSIONS HAZARDS: Emits toxic fumes under fire conditions.
===============================================================================
SECTION 5 - HEALTH DATA
===============================================================================
A. TOXICITY:
LD : Intraperitoneal-mouse: 7950 mg/kg
50
Intraperitoneal-rat: 240 mg/kg
LC : Intraperitoneal-mouse: 2500 mg/kg
50
LD : Human: 500 mg/kg
LO
B. EFFECTS OF EXPOSURE
ACUTE EFFECTS
PRIMARY ROUTE OF ENTRY: Harmful if inhalation.
INGESTION: May be harmful if swallowed.
SKIN CONTACT: May be harmful if absorbed through skin. May cause
skin irritation.
EYE CONTACT: May cause eye irritation.
INHALATION: Harmful if inhaled. Material may be irritating to
mucous membranes and upper respiratory tract.
OTHER: To the best of our knowledge, the chemical,
physical, and toxicological properties have not
been thoroughly investigated.
MEDICAL CONDITIONS, IF ANY, AGGRAVATED BY THE CHEMICAL: None known other
than those which could be aggravated by dust such as respiratory
impairment. Persons with chronic respiratory disease may be at increased
risk.
CHRONIC EFFECTS
INGESTION: None known
SKIN CONTACT: Prolonged skin contact can produce a severe dermatitis
called oxide pox.
EYE CONTACT: None known
INHALATION: Dust of fumes can irritate the respiratory tract.
OTHER: Exposure to high levels of dust or fumes can cause metallic
taste, marked thirst, coughing, fatigue, weakness, muscular
pain and nausea, followed by fever and chills. Severe
overexposure may result in bronchitis or pneumonia with a
bluish tint to the skin.
28
NANOGARD(TM) ZINC OXIDE
Page 3 of 4
-------------------------------------------------------------------------------
SECTION 5 - HEALTH DATA (CONT.)
-------------------------------------------------------------------------------
THIS IS AN EXPERIMENTAL POWDER COMPRISED OF LOOSELY AGGREGATED ULTRA FINE
NANOMETER SIZED PARTICLES. NO DATA YET EXISTS ON THE EFFECT OF SUCH FINE
PARTICLE SIZES, PER SE, ON THE BODY. SPECIAL CARE SHOULD BE TAKEN TO AVOID
INHALATION, INGESTION, SKIN CONTACT, AND EYE CONTACT.
C. EMERGENCY AND FIRST AID PROCEDURES
INGESTION: Wash out mouth with water, provided person is conscious. Call
a physician.
SKIN CONTACT: Remove contaminated clothing, wash skin clean promptly with
soap and large amounts of water.
EYE CONTACT: Immediately flush eyes, including under eyelids, with large
amounts of water for at least 15 minutes. Call a physician
if irritation persists.
INHALATION: Remove to fresh air. If not breathing, give artificial
respiration. If breathing is difficult, give oxygen. Call a
physician.
-------------------------------------------------------------------------------
SECTION 6 - REACTIVITY
-------------------------------------------------------------------------------
INCOMPATIBILITY: Materials to avoid: strong oxidizing agents.
Reacts violently with magnesium when heated
resulting in an explosion.
Mixtures of zinc oxide and chlorinated rubber
explode when heated above 215 degrees C.
HAZARDOUS DECOMPOSITION PRODUCTS: Not known
CONDITIONS TO AVOID: Fire and incompatibles.
STABILITY: Stable * Unstable
--- ---
Conditions to avoid: No data
HAZARDOUS POLYMERIZATION: May occur Will not occur *
--- ---
Conditions to avoid: No data
OTHER: No data
-------------------------------------------------------------------------------
SECTION 7 - ENVIRONMENTAL INFORMATION
-------------------------------------------------------------------------------
RCRA CODE: None
TSCA REGISTERED: Yes
SPILL AND LEAK PROCEDURES: = Wear suitable protective equipment as listed under
Section 8.
= Sweep up and containerize, and hold for waste
disposal. Avoid raising dust.
= Comply with the reporting requirements of all
Federal, State and Local regulations.
= Ventilate area and wash spill site after material
pickup is complete.
WASTE DISPOSAL: Consult state, local or federal EPA regulations for
proper disposal.
29
NANOGARD(TM) ZINC OXIDE
Page 4 of 4
-------------------------------------------------------------------------------
SECTION 8 - PROTECTION INFORMATION
-------------------------------------------------------------------------------
VENTILATION REQUIREMENTS: Use with adequate ventilation to meet the exposure
limits listed in Section 2. Where the exposure limit
is or may be exceeded, use NIOSH approved respiratory
protection. Select the appropriate dust respirator
based on the actual or potential concentration of
airborne dust from this product. Comply with all
appropriate OSHA, EPA, state and local regulations.
RESPIRATORY PROTECTION: High efficiency particle respirator
PROTECTIVE GLOVES: Rubber or plastic
EYE/FACE PROTECTION: ANSI approved safety goggles
-------------------------------------------------------------------------------
SECTION 9 - SPECIAL PRECAUTIONS
-------------------------------------------------------------------------------
HANDLING AND STORAGE: Handle in hoods or other well ventilated areas only.
Take care not to cause airborne dust to be generated
out side of ventilated areas. Keep container tightly
closed and store in a cool, dry, well ventilated area.
Wash thoroughly after use. Comply with all OSHA, EPA,
State and local regulations. Magnesium violently
reduces zinc oxide when heated, resulting in an
explosion. Mixtures of chlorinated rubber and zinc
oxide explode when heated above 215 degrees C.
OTHER PRECAUTIONS: Have available: lab coats, aprons, flame and chemical
resistant coveralls, high efficiency particle
respirators, continuously-flushing eyewash, safety
drench shower, hygienic facilities for washing. Use as
appropriate to the task being performed or the situation
being addressed.
-------------------------------------------------------------------------------
SECTION 10 - TRANSPORTATION INFORMATION - U.S. D.O.T.
-------------------------------------------------------------------------------
PER: 49 CFR 172.101
PROPER SHIPPING NAME: Not regulated
HAZARD CLASSIFICATION: None
UN NUMBER: None
PACKING GROUP: None
LABEL(S) REQUIRED: None
-------------------------------------------------------------------------------
SECTION 11 - COMMENTS
-------------------------------------------------------------------------------
The statements contained herein are offered for informational purposes only and
are based on technical data that Nanophase Technologies Corporation believes to
be accurate. It is intended for use only by persons having the necessary
technical skill, and at their own discretion and risk. Since conditions and
manner of use are outside our control, we make no warranty, express or implied,
of merchantability, fitness or otherwise.
