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EXHIBIT 10.4
AMENDED AND RESTATED SUPPLY AGREEMENT
(OPTIVAX(R) COPOLYMER)
This SUPPLY AGREEMENT is made and executed as of October 10, 1996, by
and between CYTRX CORPORATION, a Delaware corporation ("CytRx"), and VAXCEL,
INC., a Delaware Corporation ("Vaxcel").
RECITALS
WHEREAS, CytRx and Vaxcel have entered into an Optivax(TM) License
Agreement amended and restated as of October 10, 1996 (the "License
Agreement") whereby CytRx has granted to Vaxcel the exclusive worldwide right
to market and distribute or to sublicense the marketing and distribution of
products containing a certain Copolymer (as defined hereinafter) of CytRx, in
accordance with the terms specified therein; and
WHEREAS, Vaxcel wishes to have CytRx supply Vaxcel with its
requirements for the Copolymer, which Vaxcel will use for purposes of the
License Agreement, and CytRx is willing to supply such Copolymer to Vaxcel,
subject to the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants and agreements hereinafter set forth, the parties hereto,
intending to be legally bound hereby, agree as follows:
ARTICLE I
DEFINITIONS
1.1 For purposes of this Agreement, the following terms shall have the
corresponding meaning set forth below:
"Copolymer" means the polyoxyethylene/polyoxypropylene copolymer
designated as CRL-1005 in the License Agreement.
"FDA" means the U.S. Food and Drug Administration, or any successor
agency thereto.
"FDA Standards" means the facility license requirements and the Good
Manufacturing Practice regulations of the FDA applicable to the
Copolymer or the Manufacturing Facility.
"GMP Grade" means Copolymer that has been produced in accordance with
Good Manufacturing Practice regulations as defined by the FDA.
2
"Manufacturing Facility" means the manufacturing facility of CytRx, or
any manufacturing facility of a third party licensed and engaged by
CytRx to supply the Copolymer in accordance with Section 2.1.
"Manufacturing Procedures" means (i) the CytRx manufacturing
procedures used to make the Copolymer and (ii) the form of master
batch record for the Copolymer.
"Specifications" means the specifications for the Copolymer as agreed
to by the parties and made a part of this Agreement as Exhibit A
hereto. The specifications may be changed from time to time by mutual
consent of the parties.
1.2 Capitalized terms not otherwise defined herein shall have the
corresponding meaning specified in the License Agreement.
ARTICLE II
MANUFACTURE AND SUPPLY OF PRODUCT
2.1 Supply of Copolymer. During the term of this Agreement, CytRx will
supply or cause to be supplied to Vaxcel 100% of Vaxcel's direct
requirements for the Copolymers as well as 100% of Vaxcel's indirect
requirements for sublicensees, and Vaxcel will purchase all of its
requirements for the Copolymer from CytRx. CytRx shall use reasonable
efforts to ensure the supply of Copolymer to Vaxcel based on Vaxcel's
production forecasts per section 2.2 of this Agreement. CytRx, at its
discretion, may use a reputable, qualified third party to supply the
Copolymer on its behalf. In such event, CytRx shall notify Vaxcel of
the identity of such third party and CytRx shall be responsible at
CytRx's expense for the qualification of and the performance of such
third party. If CytRx or its licensed third party chemical
manufacturer is unwilling or unable to supply the Copolymer, then
Vaxcel and/or its sublicensees shall have the right to make or have
made the Copolymer. In such instance, CytRx agrees to make
appropriate manufacturing know how available to Vaxcel or its
designee.
2.2 Production Forecasts. Vaxcel will deliver to CytRx, on the first day
of each calendar quarter, a requirements forecast indicating Vaxcel's
monthly requirements for quantities of the Copolymer during the twelve
(12) months, beginning with the next calendar month. The specified
quantities for the first four (4) months of each 12-month forecast
shall be deemed a firm purchase commitment for such quantities and
shall be documented by purchase order per section 2.3 of this
Agreement. CytRx shall not accept any production forecasts from
Vaxcel sublicensees.
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2.3 Purchase Orders
(a) Vaxcel shall submit a purchase order for Copolymer at
least 120 days prior to the shipment specified in the order.
The purchase order shall constitute a firm commitment by
Vaxcel to purchase the Copolymer.
(b) The parties understand the potential seasonal nature of
requirements for the Copolymer. In order to ensure adequate
lead time for significant increases in requirements, Vaxcel
shall submit a firm commitment purchase order at least 210
days in advance of requesting shipment of Copolymer greater
than 125% of the average monthly quantity shipped over the
preceding twelve months.
(c) All orders for Copolymer shall be ordered in full batches
from one of the following Batch Categories:
"Small Pilot" X X X kilograms
"Large Pilot" greater than X kilograms
"Small Commercial" greater than XX kilograms
"Large Commercial" greater than XX kilograms
(d) CytRx shall from time to time provide Vaxcel with batch
sizes available within each Batch Category. CytRx shall
consult with Vaxcel prior to changing batch sizes.
2.4 Price.
(a) The Purchase Price ("Purchase Price") for quantities of
Copolymer will be determined by Batch Category. Batch
Category Purchase Prices as of January 1, 1995 is made part of
this Agreement as Exhibit B hereto.
(b) The Purchase Price shall automatically be increased or
decreased as of January 1 of each year based on the percentage
change up or down in the Producer Price Index (PPI) as
reported by the U.S. Department of Labor over the immediately
preceding twelve months.("the PPI Change Percent"). The
initial base year for this price adjustment shall be 1995.
The Purchase Price shall be adjusted as follows: The Purchase
Price multiplied by the PPI Change Percent equals the amount
of change in the Purchase Price ("the Adjustment Amount").
Where the PPI has increased, the Adjustment amount shall be
added to the Purchase Price; where the PPI has decreased, the
Adjustment Amount shall be subtracted from the Purchase Price
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2.5 Payment
(a) CytRx shall invoice Vaxcel for the Purchase Price of the
Copolymer when shipped. Each shipment of Copolymer shall
constitute a separate sale obligating Vaxcel to pay therefor.
Each CytRx invoice shall be due and payable within thirty (30)
days after the date thereof. Payments received after the due
date shall be subject to penalty for late payment accruing
from the date of shipment at Prime Rate plus two percent
calculated on the total invoice amount.
(b) All payments shall be made in legal currency of the
United States of America, by corporate check to CytRx at the
address specified in Section 5.3 hereof.
2.6 Shipping Requirements.
(a) CytRx will choose a commercially reasonable method of
shipment and a carrier for each shipment of Copolymer unless
Vaxcel has specified a particular method of shipment in its
purchase order. Title and risk of loss, delay or damage in
transit shall pass to Vaxcel upon delivery by CytRx of the
Copolymer to a common carrier or other means of transport at
the Manufacturing Facility. All purchase orders shall be
designated FOB point of origin.
(b) If Vaxcel takes delivery at the Manufacturing Facility,
title and risk of loss, delay or damage shall pass to Vaxcel
upon actual delivery. Should Vaxcel request, and CytRx agree
to storage by CytRx of Copolymer so delivered, such storage
shall be at Vaxcel's expense.
(c) Vaxcel at its option may specify direct delivery by CytRx
of all or part of a batch to a third party as designated by
Vaxcel. All third party designated shipments shall have the
full drop shipment address indicated on the purchase order.
(d) Vaxcel shall promptly reimburse CytRx in U.S. currency
for the costs of insurance and freight with respect to the
Copolymer, FOB the Manufacturing Facility. Vaxcel shall
provide CytRx, on request, with properly completed exemption
certificates for any tax from which Vaxcel claims exemption.
(e) Vaxcel shall be responsible for payment of any tariffs,
customs duty or similar costs and fees associated with the
shipment of Copolymer to Vaxcel or to a third party designated
by Vaxcel.
(f) CytRx shall make reasonable efforts to deliver Copolymer
as specified in the purchase order. However, any shipment by
CytRx of Copolymer
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within the following variances shall constitute compliance by
CytRx with the applicable purchase order requirements:
(i) the quantity in kilograms may vary by plus or
minus 10% from the batch sizes specified on each purchase
order; and
(ii) the delivery date may vary plus or minus 30
days from the date specified in the purchase order.
2.7 Warranties. CytRx warrants that each shipment of the Copolymer shall
be manufactured, temporarily stored, packaged, labeled, and controlled
by CytRx in accordance with the Specifications, the Manufacturing
Procedures and applicable FDA Standards. EXCEPT AS SET FORTH IN THE
PRECEDING SENTENCE, CYTRX MAKES NO EXPRESS OR IMPLIED WARRANTIES,
STATUTORY OR OTHERWISE, CONCERNING THE PRODUCT. SPECIFICALLY, BUT
WITHOUT LIMITING THE FOREGOING, CYTRX MAKES NO EXPRESS OR IMPLIED
WARRANTY OF MERCHANTABILITY, FITNESS (FOR A PARTICULAR PURPOSE OR
OTHERWISE), QUALITY OR USEFULNESS OF THE PRODUCT. CYTRX SHALL IN NO
EVENT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES INCURRED
BY VAXCEL.
2.8 Quality Assurance Requirements
(a) Concurrent with each shipment, CytRx will provide to
Vaxcel a Certificate of Analysis that the Copolymer conforms
to the Specifications.
(b) CytRx will provide Vaxcel with sufficient samples of each
production run of the Copolymer as Vaxcel may reasonably
request.
(c) CytRx will not modify the Specifications or any of the
Manufacturing Procedures without obtaining the prior consent
of Vaxcel, which consent shall not be unreasonably withheld,
and/or appropriate regulatory authorities.
2.9 Testing and Rejection of the Copolymer.
(a) CytRx shall conduct the testing of the Copolymer before
shipment using the validated analytical methodology specified
in Exhibit C, and shall provide Vaxcel with a certification of
the test results. Vaxcel may either accept the Copolymer
based on the CytRx test results or may elect to test samples
of the corresponding production run using the approved testing
methodology per Exhibit C.
(b) Within 30 days after receipt of each shipment of
Copolymer by CytRx, Vaxcel or its designee shall have the
right to reject any shipment
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that fails to meet the applicable Specifications or FDA
Standards. Vaxcel's right of rejection may be exercised by
delivery of notice to CytRx within the 30 day period,
identifying the rejected Copolymer by production lot number
and stating the basis for rejection. If Vaxcel does not
reject the shipment within 30 days, it will be deemed to have
accepted the shipment. Upon the request of CytRx, Vaxcel
shall furnish evidence of nonconformity of the shipment of
Copolymer. If CytRx disagrees with Vaxcel's determination,
the parties shall submit the dispute to a mutually acceptable
laboratory for a binding determination of the conformity or
nonconformity of the Copolymer. The nonprevailing party shall
pay the costs and expenses of the laboratory tests. If Vaxcel
properly rejects the Copolymer, Vaxcel shall receive a credit
for any amounts already paid to CytRx for the rejected
Copolymer against the Purchase Price for the next shipment of
Copolymer accepted by Vaxcel, or shall be reimbursed for such
payment with interest at the prevailing prime rate per annum
at the option of CytRx. Vaxcel shall be responsible for the
destruction of all rejected Copolymer (in compliance with
applicable law) or the return of the shipment, at the expense
of CytRx, at the discretion of CytRx.
(c) If Vaxcel or its designee rejects a shipment per section
2.9(b), at Vaxcel's request, CytRx shall use every reasonable
effort to provide an equivalent quantity in a timely fashion
to replace the batch in question until such time as a
definitive disposition of the batch in question is
forthcoming. The terms and conditions of this Agreement shall
apply for this provisional quantity.
(d) Vaxcel shall be responsible for all stability testing of
the Copolymer. If so requested by Vaxcel, CytRx shall pull
samples of Copolymer for stability testing purposes, and shall
ship such samples at Vaxcel's expense in accord with
instructions from Vaxcel.
2.10 Record Keeping. CytRx will maintain the manufacturing, production and
control records for the Copolymer for the periods required by
applicable FDA Standards and, in any event, will provide Vaxcel the
opportunity to take possession of such records before they are
destroyed.
2.11 Regulatory Approvals. CytRx shall obtain and maintain any
establishment license, facility license or other license,
authorization or approval required by the FDA or any other federal,
state or local governmental authority for the manufacture of the
Copolymer as contemplated hereunder. Vaxcel shall reimburse CytRx for
meeting any additional requirements imposed by international
regulatory agencies.
2.12 Manufacturing Information. CytRx hereby grants Vaxcel permission to
reference CytRx's Drug Manufacturing File (DMF) concerning the
manufacture of the Copolymer as shall be required by Vaxcel to obtain
regulatory approvals.
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2.13 Compliance with Laws. Vaxcel and its sublicensees shall comply with
all applicable laws in the manufacture of finished product using the
Copolymer and in the promotion, marketing and sale of all such
products.
2.14 Notification. Vaxcel shall notify CytRx of any adverse or unexpected
results, or any potential government action relevant to the Copolymer.
ARTICLE III
TERM AND TERMINATION
3.1 Term of the Agreement. The term of this Agreement shall begin as of
the effective date hereof and shall end on the date of termination of
the License Agreement, unless this Agreement is terminated earlier in
accordance with the provisions of Sections 3.2 or 3.3 hereof.
3.2 Termination by CytRx. CytRx shall have the right to terminate this
Agreement by giving written notice of termination, such termination
effective with the giving of such notice, upon (i) failure of Vaxcel
to pay any amount payable to CytRx that is continuing (30) calendar
days after CytRx gives Vaxcel written notice of such non payment; or
(ii) termination of the License Agreement by CytRx in accordance with
its terms.
3.3 Termination by Either Party. This Agreement may be terminated by
either party before expiration of its stated term, by giving written
notice of termination, such termination effective upon the giving of
such notice, as follows:
(a) breach by the other party of any covenant (other than a
payment covenant covered by Section 3.2) or of any
representation or warranty contained in this Agreement that is
continuing sixty (60) calendar days after the non-breaching
party gives the breaching party written notice of such breach;
or
(b) the non-terminating party becomes insolvent, or voluntary
or involuntary proceedings by or against the non-terminating
party are instituted in bankruptcy or under any insolvency
law, or a receiver or custodian is appointed for the non-
terminating party, or proceedings are instituted by or against
the non-terminating party for corporate reorganization or the
dissolution of the non-terminating party, which proceedings,
if involuntary, shall not have been dismissed within sixty
(60) days after the date of filing, or the non-terminating
party makes an assignment for the benefit of creditors; or
(c) The cessation of operations by the non-terminating party
(other than pursuant to a merger, reorganization or
consolidation in which the non-
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terminating party is not the surviving corporation or a sale
by the non-terminating party of all or substantially all of
its assets); or
(d) the seizure or attachment of all or substantially all of
the assets of the non-terminating party, in conjunction with
any action against it by any third party, which seizure or
attachment is not released within forty-five (45) days after
such seizure or attachment and which is contested in good
faith by the non-terminating party.
Upon the occurrence of any Event of Default (as defined in the License
Agreement), CytRx shall have the right to terminate this Agreement by
giving written notice of termination, such termination to be effective
with the giving of such notice.
No exercise by CytRx of any right of termination will constitute a
waiver of any right of CytRx for recovery of any moneys then due to it
hereunder or any other right or remedy it may have by law or by this
Agreement.
3.4 Survival. Notwithstanding the termination of this Agreement, however
caused, Vaxcel's obligations to pay for Copolymer shipped prior the
date of termination shall survive such termination until satisfied in
full. In addition, Article IV and any other provisions required to
interpret this Agreement shall survive the termination of this
Agreement to the extent required for the full observation and
performance of the surviving terms and rights and obligations of the
parties arising prior to the termination hereof.
ARTICLE IV
INDEMNIFICATION
4.1 Indemnification by CytRx. CytRx shall indemnify and hold harmless
Vaxcel and its Affiliates, employees, officers, directors,
stockholders and agents (a "Vaxcel Indemnified Party") from and
against any and all liability, loss, damages, costs, or expenses
(including reasonable attorneys' fees) which the Vaxcel Indemnified
Party may incur, suffer or be required to pay resulting from or
arising in connection with (i) the breach by CytRx of any covenant,
representation or warranty contained in this Agreement, including
without limitation, the breach of CytRx's warranty contained in
Section 2.7 hereof (a "CytRx Liability"), or (ii) the enforcement by a
Vaxcel Indemnified Party of any of the foregoing.
4.2 Indemnification by Vaxcel. Vaxcel shall indemnify and hold harmless
CytRx and its Affiliates, employees, officers, directors, stockholders
and agents (a "CytRx Indemnified Party") from and against any and all
liability, loss, damages, costs, or expenses (including reasonable
attorneys' fees) which the CytRx Indemnified Party may incur, suffer
or be required to pay resulting from or arising in
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connection with (i) the breach by Vaxcel of any covenant,
representation or warranty contained in this Agreement, (ii) the
manufacturing, marketing, sale or distribution of products containing
the Copolymer by Vaxcel or any person on behalf of Vaxcel, (iii) the
use by any person of any product containing the Copolymer that was
manufactured, marketed, sold or distributed by Vaxcel or any Affiliate
or sublicensee of Vaxcel, or (iv) the successful enforcement by a
CytRx Indemnified Party of any of the foregoing.
4.3 Additional Rights and Obligations. The rights and obligations of each
party under this Article IV are in addition to any indemnification
rights and obligations of the parties set forth in the License
Agreement.
4.4 Certain Procedures. Either party shall, within 10 days of its notice
of any claim or suit brought in connection with the Copolymer, notify
in writing the other party of such claim or suit. Either party shall
have the right at its own expense to participate in the defense of any
claim or suit brought in connection with the Copolymer and the parties
agree to coordinate their efforts in this regard.
ARTICLE V
MISCELLANEOUS
5.1 Representations of the Parties. Each party represents and warrants to
the other party that this Agreement has been duly authorized, executed
and delivered and that the performance of its obligations under this
Agreement does not conflict with any order, law, rule or regulation or
any agreement or understanding by which such party is bound.
5.2 Force Majeure. Failure of CytRx to make, or Vaxcel to take, any one
or more deliveries when due, if caused by fire, storms, floods,
strikes, lockouts, accidents, war, riots or civil commotions,
inability to obtain railroad cars or raw materials, embargoes, any
State or Federal regulation, law, or restriction, seizure or
acquisition of Copolymer by the Government of the United States or of
any state, or of any agency thereof or by reason of any compliance
with a demand or request for such product for any purpose for national
defense, or any other cause or contingency beyond the reasonable
control of said party (whether or not of the same kind or nature as
the causes or contingencies above enumerated) shall not subject the
party so failing to any liability to the other, and the total contract
quantity shall be reduced to the extent of the deliveries so omitted.
5.3 Notices. Any notice or other communication required or permitted to
be made or given to either party hereto pursuant to this Agreement
shall be sufficiently made or given if sent to such party by either
telecopy transmission or certified or registered first class mail,
postage prepaid, return receipt requested addressed to it as follows:
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If to CytRx:
CytRx Corporation
000 Xxxxxxxxxx Xxxxxxx
Xxxxxxxx, XX 00000
FAX No. (000) 000-0000
Attention: Vice President, Finance
with a copy to:
Xxxxxx & Bird
One Atlantic Center
0000 Xxxx Xxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxx 00000-0000
FAX No. (000) 000-0000
Attention: Xxxxxx X. Xxxxxxx, Xx.
If to Vaxcel:
Vaxcel Corporation
000 Xxxxxxxxxx Xxxxxxx
Xxxxxxxx, XX 00000
FAX No. (000) 000-0000
Attention: President
or to such other address as either party shall designate by written
notice, similarly given, to the other party. Any notice if given or
made by certified or registered first class mail letter, return
receipt requested, shall be deemed to have been received on the
earlier of the date actually received and the date three (3) days
after the same was posted (and in proving such it shall be sufficient
to prove that the envelope containing the same was properly addressed
and posted as aforesaid) and if given or made by telecopy transmission
shall be deemed to have been received at the time of dispatch, unless
such date of deemed receipt is not a business day, in which case the
date of deemed receipt shall be the next succeeding business day.
5.4 Entire Agreement; Amendment. This Agreement, together with the
Exhibits annexed hereto sets forth and constitutes the entire
agreement between the parties hereto with respect to the subject
matter hereof, and supersedes any and all prior agreements,
understandings, promises, and representations made by either party to
the other concerning the subject matter hereof and the terms
applicable hereto. This Agreement may not be released, discharged,
amended or modified in any
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manner except by an instrument in writing signed by duly authorized
representatives of Vaxcel and CytRx.
5.5 Parties Independent. In making and performing this Agreement, the
parties act and shall act at all times as independent entities and
nothing contained in this Agreement shall be construed or implied to
create an agency, partnership or employer and employee relationship
between Vaxcel and CytRx. Except as specifically provided herein, at
no time shall either party make commitments or incur any charges or
expenses for or in the name of the other party.
5.6 Governing Law. This Agreement shall be deemed to have been entered
into and shall be construed and enforced in accordance with the laws
of the State of Delaware.
5.7 Waivers. The failure of either party to insist, in any one or more
instances, upon the performance of any of the terms, covenants or
conditions of this Agreement and to exercise any right hereunder,
shall not be construed as a waiver or relinquishment of the future
performance of any such term, covenant or condition or the future
exercise of such right, but the obligations of the other party with
respect to such future performance shall continue in full force and
effect.
5.8 Headings. The headings of the articles, sections and paragraphs used
in this Agreement are included for convenience only and are not to be
used in construing or interpreting this Agreement.
5.9 Assignability. This Agreement shall not be assignable by either party
without the prior written consent of the other party, except that such
consent is not required in connection with the assignment of either
party's rights or obligations hereunder to an Affiliate thereof.
5.10 Effect of Invalidity of Certain Provisions. Any term or provision of
this Agreement which is invalid or unenforceable in any jurisdiction
shall, as to such jurisdiction, be ineffective to the extent of such
invalidity or unenforceability without rendering invalid or
unenforceable the remaining terms and provisions of this Agreement.
5.11 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 together shall constitute but one and the same
instrument.
5.12 Additional Copolymers. If Vaxcel requests CytRx to synthesize and
supply a copolymer(s) different than CRL-1005 (including CRL-1005
synthesized by SCF process) in the Field as defined in the License
Agreement, CytRx will offer to
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supply such copolymer(s) to Vaxcel upon terms substantially similar to
those set forth in this Agreement if they are substantially similar in
structure and require similar manufacturing procedures with similar
cost. In the event the cost of CytRx supplying such copolymer(s) to
Vaxcel is not similar to CRL-1005 or involves other manufacturing
processes (such as SCF), the parties will negotiate a revised Purchase
Price and all other terms of this Agreement will remain substantially
unchanged. Quantities of such copolymer(s) for initial evaluation and
testing shall be subject to increased costs for experimental
synthesis, development, scale-up, and documentation of manufacturing
processes.
5.13 Agreement not to Solicit. Vaxcel agrees that during the term of this
Agreement and for a period of five years following the termination of
the Agreement that it will not, either directly or indirectly, on
Vaxcel's behalf or on behalf of others, solicit or attempt to solicit
for the purpose of being employed any person then employed in chemical
synthesis or manufacturing by CytRx or its Affiliates, whether or not
employment of any such person is pursuant to a written agreement, for
a determined period or at will.
5.14 Confidentiality.
(a) Vaxcel agrees that during the term of this Agreement and
for a period of five years following the termination of the
Agreement to keep all technical information regarding the
Copolymer in trust and confidence and not to disclose to
others, nor to use for any purpose other than that
specifically outlined in this Agreement and the License
Agreement. This agreement of confidentiality includes
information received in writing or verbally, whether received
intentionally or unintentionally, during the course of
Vaxcel's business with CytRx, its Affiliates, or its third
party subcontractors.
(b) CytRx agrees that during the term of this Agreement and
for a period of five years following the termination of the
Agreement to keep all information gained in administering the
Agreement in trust and confidence and not to disclose to
others, nor to use for any purpose other than that
specifically outlined in this Agreement and the License
Agreement. This agreement of confidentiality includes
information received in writing or verbally, whether received
intentionally or unintentionally, during the course of CytRx's
business with Vaxcel, its Affiliates, or its sublicensees.
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of
the date first above written.
VAXCEL, INC. CYTRX CORPORATION
By /s/ XXXX X. XXXXXX By /s/ XXXX X. XXXXXXX
-------------------------- -----------------------------
Xxxx X. Xxxxxx Xxxx X. Xxxxxxx
President and CEO President and CEO
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EXHIBIT A
SPECIFICATIONS FOR COPOLYMER CRL-1005
XXX-POP-XXX block copolymer 1305, CRL-1005, is a clear, colorless to slightly
yellow viscous liquid.
Names: XXX-POP-XXX block copolymer 000
XXX-0000
Xxxxxxx, methyl-, polymer with oxirane
alpha-Hydro-omega-hydroxy-poly(oxyethylene)a-poly(oxypropylene)b-poly
(oxyethylene)a block copolymer
Empirical formula:
H-(C2H4O)a-(C3H6O)b-(C2H4O)2-OH
in which a = 9 plus/minus 1. and b = 216 plus/minus 27 (based on peak
MW)
Molecular Mass:
Peak MW 13.300 plus/minus 1.700 daltons
Wt. Avg. MW 11.100 plus/minus 1.300 daltons
CAS #: 9003-11-6
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EXHIBIT B
PURCHASE PRICE FOR QUANTITIES OF COPOLYMER
AS OF JANUARY 1, 1995
BATCH CATEGORY PRICE PER KILOGRAM*
-------------- -------------------
"Small Pilot" (XXXXX kg) $XXXXXX
-----------
"Large Pilot" (XXXXXX kg) $XXXXXX
------------
"Small Commercial" (XXXXXXX kg) $XXXXXX
----------------
"Large Commercial" (XXXX kg) $XXXXXX
----------------
* Prices are FOB Manufacturing Facility and specifically exclude freight,
insurance, customs fees, etc.
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EXHIBIT C
VALIDATION OF CRL-1005
Specifications and Acceptance Limits
Specification Acceptance limits Analytical method
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Appearance Clear, colorless to slightly yellow, Visual observation
viscous liquid
Identification Conforms to FTTR spectrogram of FTTR method LM56
standard by visual comparison
Molecular weight: GPC method LM34
Peak 13.300 plus/minus 1.700 daltons
Weight average 11.100 plus/minus 1.300 daltons
Less than 7000 xxxxxx NMT 25%
Weight % poly(oxyethylene) *NLT 5% and NMT 7% (1)H-NMR per NF monograph
(poloxamer)
Unsaturation NMT 0.10 mEq/gm Titration method LM41
Volatile organic impurities:
benzene NMT 100 ppm GC Method LM61
chloroform NMT 50 ppm
methylene chloride NMT 100 ppm
trichloroethylene NMT 100 ppm
1,4-dioxane NMT 5 ppm
ethylene oxide NMT 5 ppm
propylene oxide NMT 5 ppm
ethylene glycol Report result GC Method LM60-2
propylene glycol Report result
pH of 2.5% aqueous soln. NLT 4.0 and NMT 7.0 CytRx method LM67
at 2 plus/minus 2 degrees C
XXXXXXX XXXXXXX XXX XX XXX XXXXXXXXX XXXX XXXXXX
XXXXXX XXXXXX XXXXXXXXXXX
Heavy metals NMT 0.002% NF monograph (poloxamer)
Cloud Point NLT 4.0 degrees C and NMT 7.0 degrees C CvtRx method LM47-2
----------------------------------------------------------------------------------------------------------------------------
NLT = not less than. NMT = not more than
Storage
Store at 2 to 8 degrees C in a tightly closed container under a blanket of Nitrogen or Argon gas.
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