EXHIBIT 10(w)
MASTER PRODUCTION AGREEMENT
This Master Production Agreement (this "Agreement") is made as of this 19th
day of June, 2000, between Bio Science Contract Production Corp., a Maryland
corporation ("BSCP"), and Cel-Sci Corporation, 0000 Xxxxx Xxxxxxxxx, Xxxxx 000,
Xxxxxx, Xxxxxxxx, a Colorado corporation ("Client").
RECITALS
A. BSCP operates a multi-client production facility, operated in accordance
with the U.S. Food and Drug Administration's (the "FDA") current Good
Manufacturing Practices, located at 0000 Xxxx Xxxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxx 00000 (the "Facility").
B. From time to time, Client desires to produce, one or more Products (as
hereinafter defined) at the Facility. Each Product shall be described in a
separate Schedule A-( ) (each Product produced pursuant to this Agreement and
the Schedules hereto shall be separately sequentially numbered and identified,
beginning with "1", and the blank spaces set forth within the parenthesis to
each Schedule shall contain such number, for example, the Schedules for the
first Product shall be Schedule A-(1), Schedule B-(1), etc.). Each Product shall
be produced in accordance with the terms and subject to the conditions
hereinafter set forth and contained in the Schedules hereto.
C. Client holds the requisite proprietary rights to each Product to enable
each Production to be produced pursuant to this Agreement.
D. Client shall produce each Product pursuant to the Production Record for
each Product and to the BSCP and Client Operating Documents. Based on the
information provided to BSCP pursuant to Paragraph 1 below, BSCP shall prepare,
and Client shall approve, the Production Record for each Product in accordance
with the terms of this Agreement.
NOW, THEREFORE, in consideration of the foregoing and the mutual promises
and covenants hereinafter set forth, BSCP and Client, intending to be legally
bound, hereby agree as follows:
Definitions
The following capitalized terms used in this Agreement shall have the following
meanings:
"BSCP Parties" means BSCP, its employees, agents and affiliates.
"Commencement Date" with respect to each Product will be set forth on
Schedule B-(__) attached hereto, relating to that Product.
"Termination Date" for each Product will be set forth on Schedule
B-(__) attached hereto, relating to that Product.
"Materials" shall mean all raw materials to be used to produce the
Product.
"Product" shall mean each bulk substance that BSCP has agreed to
produce pursuant to the Production Record relating thereto.
"Production Area" shall mean that portion of the Facility designated
for the production of the Product.
"Production Record" shall mean the Client-specific records required to
produce each Product in the Facility including both the Master Production Record
and/or the Batch Production Records as defined in 21 CFR 211.186 & 21 CFR
211.188.
"Production Term" shall mean, for each Product, that period commencing
on the Commencement Date and terminating on the Termination Date.
"BSCP Operating Documents " shall mean the standard operating
procedures, standard manufacturing procedures, specifications, protocols,
validation documentation, and supporting documentation, such as environmental
monitoring, for operation and maintenance of the Facility and BSCP equipment.
"Client Operating Documents " shall mean the standard operating
procedures, standard manufacturing procedures, specifications and validation
documentation specific to the Client's Product and Client equipment.
"Campaign" shall mean that period of time where the Product is actively
being produced in the Production Area.
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1. Production Record. The Production Record shall be prepared by the Client
in conformance with BSCP's policies and practices. Upon written notification to
BSCP that the Production Record is satisfactory, the Production Record shall be
deemed approved and accepted by Client. BSCP will authorize the Production
Record and photocopy it for use in Client's production campaigns.
2. Personnel, Equipment and Utilities. In connection with the production of
each Product hereunder in the Production Area, BSCP shall supply personnel,
production equipment, and utilities. Client shall be responsible for providing
to BSCP, in a timely manner, all personnel, production equipment, and utilities,
other than those to be supplied by BSCP, required to produce each Product
pursuant to its Production Record (unless BSCP otherwise agrees in writing, to
provide such items). Any Client-provided items with respect to the production of
a Product are as set forth in Schedule C-( ) attached hereto.
3. Production Term. The Production Term is set forth in Schedule B-( )
attached hereto relating to that Product. The term of this Agreement shall
continue in full force and effect for a period ending on the later of 10 years
from the date hereof or the Termination Date of the final Product to be produced
hereunder.
4. Compensation. Compensation for production of each Product under this
Agreement shall be payable by Client to BSCP as follows:
(a) Monthly Fee.
(i) For each Product, Client shall pay to BSCP a monthly fee (the
"Monthly Fee") as set forth in Schedule B-( ) attached hereto. The Monthly Fee
shall be due and payable in advance of the Commencement Date and on the same
calendar date of each subsequent month during the Production Term (if the
Production Term includes a period of time which is less than a full month, the
Monthly Fee for the days in the partial month shall equal the number of days in
that partial month multiplied by the daily rate, which is the Monthly Fee
divided by 30).
(ii) Materials and consumables are not included in the Monthly
Fee, but shall be paid for by Client at BSCP's cost for such materials and
consumables upon receipt of the invoice sent by BSCP to Client each month.
(iii) Out-sourced services (e.g. testing or cell banking) to
external laboratories is not included in the Monthly Fee but shall be paid for
by Client at BSCP's cost for such services upon receipt of the invoice sent by
BSCP to Client. Client shall pay BSCP costs (time and travel expenses) for BSCP
audits for such external laboratories if required.
(b) Other Charges. As required to produce the Product, BSCP may provide
additional personnel, consultants, materials, production equipment and utilities
to Client (collectively the "Other Production Requirements"). Client shall pay
BSCP for the provision of the Other Production Requirements as agreed upon in
advance by BSCP and Client, as set forth in Schedule D-( ) attached hereto.
Client shall pay for such Other Production Requirements upon receipt of the
invoice sent by BSCP to Client, except if such charges are anticipated to exceed
$25,000, then Client shall pay such charges in advance. Client shall provide, in
Schedule D-( ) attached hereto, a list of all hazardous wastes or substances,
and the anticipated quantities, that will be used in the production process for
each Product. BSCP shall notify Client of those hazardous wastes or substances
that cannot be disposed of through BSCP's waste disposal system in the
quantities that Client proposes will be produced in connection with the
production of each Product. Client agrees to pay for the disposal by BSCP of
such materials that cannot be disposed of by BSCP in accordance with the rates
set forth on Schedule D-( ) attached hereto. To the extent that any incorrect
information provided by Client on Schedule D-( ) attached hereto results in
increased costs to BSCP to dispose of hazardous wastes or substances, Client
shall pay those incremental costs. The waste disposal charges shall be paid upon
receipt of the invoice sent by BSCP to Client.
(c) Taxes. Client agrees to pay for any sales and use taxes or other
(the "Taxes") resulting from BSCP's production of each Product hereunder (except
for income or personal property taxes payable by BSCP). To the extent not paid
by Client, Client shall indemnify and hold harmless the BSCP Parties from and
against any and all penalties, fees, expenses and costs, whatsoever, in
connection with the failure by Client to pay the Taxes. BSCP shall not collect
any sales and use taxes from Client in connection with the production of any
Product hereunder if Client obtains an exemption therefrom. In furtherance of
the foregoing, BSCP shall not collect sales and use taxes from Client in
connection with the production of any Product hereunder if (i)(A) Client
provides a certificate to BSCP in which it states that such Product will be used
or consumed outside of the State of Maryland and (B) Product is either shipped
directly outside the State of Maryland or stored in Maryland pending shipment to
another State or (ii) Client provides a certificate to BSCP in which it states
that such Product is for resale.
(d) Late Charge; Interest. Any fee, charge or other payment due to BSCP
by Client hereunder (including, without limitation, pursuant to a Schedule
attached hereto) that is not paid within 30 days after it is due shall accrue
interest, from the date when the same was due and payable, at the rate of
eighteen percent (18%) per annum, payable on demand. If unpaid for more than 60
days, BSCP may terminate this Agreement, in which event, Client shall
immediately vacate the Production Area and simultaneously pay to BSCP the unpaid
balance of the Monthly Fees for each Product that are payable during the
remainder of the Production Term for each Product, and any other Obligations (as
defined in subparagraph (h) below) relating to each Product, all of which shall
become immediately due and payable.
(e) Payments. All payments to BSCP hereunder by Client shall be by
check, wire transfer, money order, or other method of payment approved in
writing by BSCP.
(f) Security Deposit. Client shall, simultaneously with the execution
and delivery of the applicable Schedules attached hereto relating to the
production of each Product, remit to BSCP a security deposit (each, a "Security
Deposit") in an amount equal to $125,000 for each Product; provided, however,
that if Client shall have already remitted to BSCP a reservation deposit with
respect to a Product pursuant to the terms of a reservation deposit agreement
with BSCP, then the amount of said reservation deposit (the "Reservation
Deposit") shall be withdrawn by BSCP and credited toward the Security Deposit
payable with respect to a Product (Client shall be responsible for remitting any
deficiency between the amount of the Reservation Deposit and the Security
Deposit required hereunder). Each Security Deposit shall be returned to Client
within 60 days after the termination of each Production Term relating to each
Product if Client has paid all fees, charges, or other payments due in
connection with the production of each Product, including charges for lost,
destroyed, stolen or damaged property of BSCP (all such fees, charges, or other
payments being called "Obligations"). If any Obligations with respect to a
Product remain outstanding after the expiration of such 60-day period, then BSCP
shall be entitled to apply the Security Deposit against the payment of such
Obligations, and the amount of the Security Deposit remaining, if any, after the
application of such payments shall be returned to Client. Client shall remain
liable to BSCP for any deficiencies remaining after the application of the
Security Deposit against the Obligations.
(g) Damage to Equipment. Client shall be responsible for the reasonable
cost of repairing or replacing (to the extent that BSCP determines, in its
reasonable judgment that repairs cannot be adequately effected) any BSCP
equipment damaged or destroyed by Client Personnel, as defined in Paragraph 5(b)
hereof (ordinary wear and tear excepted).
5. The Production Process.
(a) The Production Record. Client and BSCP shall adhere to the
Production Record in producing each Product, except to the extent that such
Production Record conflicts with applicable law, in which event, Client shall
comply with applicable law. Client will maintain accurate records for the
production of each Product. Client shall own the Production Record and shall
make copies available to BSCP. BSCP will own all BSCP Operating Documents, and
shall make copies thereof available to Client upon Client's request and at
Client's expense. BSCP Operating Documents shall remain BSCP Confidential
Information. Client Operating Documents shall remain Client Confidential
Information.
(b) Client Personnel. Client's employees and agents (including its
independent contractors) (collectively, "Client Personnel") may participate in
the production of each Product in those capacities approved in writing in
advance by BSCP. Client Personnel working at the Facility shall be and remain
employees of Client, which shall be solely responsible for (i) the payment of
their compensation (including applicable Federal, state and local withholding,
FICA and other payroll taxes, workers' compensation insurance, health insurance,
and other similar statutory and fringe benefits) and (ii) the payment of any and
all expenses, costs, claims and losses (including, but not limited to attorneys'
fees and related expenses) in connection with injuries suffered by Client
Personnel while at the Facility or elsewhere (such expenses, costs, claims,
losses, attorneys' fees and related expenses being hereinafter collectively
called, "Injury Expenses"). Client covenants and agrees, with respect to Client
Personnel working at the Facility, to maintain workers' compensation benefits
and employers' liability insurance as required by applicable Federal and
Maryland laws.
(c) BSCP Personnel. Client agrees not to actively recruit for
employment (or for use as an independent contractor) BSCP employees.
(d) No Product Development; No Representations or Warranties as to
Safety of Product; Products Liability Insurance. Client acknowledges that
neither BSCP nor BSCP personnel will engage in any Product development (other
than the production of each Product pursuant to the Production Record). BSCP
makes no representation or warranty regarding each Product's safety or
effectiveness or otherwise. Client acknowledges and agrees that neither BSCP nor
its personnel have participated in the invention or testing of any Product, or
have evaluated its safety or suitability for use in humans or others. Other than
quality control testing of each Product by BSCP as required by the Production
Record, BSCP shall not be in any way responsible for Product testing. Client
shall maintain, at all times during the term of this Agreement and for three
years thereafter, a products liability insurance policy (the "Insurance Policy")
with limits of not less than $5,000,000, and shall provide a Certificate of
Insurance to BSCP that the Insurance Policy has been endorsed to designate BSCP
as an additional named insured. Client shall maintain the Insurance Policy with
an insurance company that is licensed to do business in the State of Maryland
and that is reasonably acceptable to BSCP (BSCP agreeing that an insurance
company with a policyholders' rating of at least A and a financial rating of at
least XII is acceptable). The Insurance Policy shall contain a provision
requiring at least 30 days prior written notice to BSCP before it can be
terminated.
(e) Delivery of Each Product; Other Shipping Charges. Upon completion
of the Production Term for a Product (or sooner upon Client's instructions),
BSCP shall ship (i) the Product, and (ii) Client Supplied Equipment, samples, or
any other client owned items (together with the Product being shipped, the
"Shipped Items"). All such shipments shall be in accordance with Client's
packing and shipping instructions and procedures supplied by Client as part of
the Production Record or, with respect to the items referenced in subparagraph
(ii) above, as provided by Client to BSCP, and shall be by common carrier unless
otherwise specified by Client. Delivery shall be F.O.B. Shipping Point (the
Facility). Client shall provide its preferred carrier's account number and shall
pay for all shipping costs in connection with the delivery of each Shipped Item.
BSCP's responsibility, except as set forth herein, ceases and Client's risk of
loss arises, upon BSCP's delivery of each Shipped Item to the common carrier.
(f) BSCP Liability for Destroyed or Damaged Client Production Equipment
and Materials; Dispute.
(i)(A) If during a Product production process, Production
Equipment supplied by Client ("Client Production Equipment") is destroyed or
damaged by BSCP Personnel and such damage or destruction resulted from BSCP's
failure to execute such Product production process in conformity with the
Production Record, then, except as provided in subparagraph (i)(B) below, BSCP
shall be responsible for repairing or replacing the destroyed or damaged Client
Production Equipment or, at BSCP's sole option, paying to Client the replacement
value of the damaged or destroyed Client Production Equipment at the time of its
damage or destruction. In no other event shall BSCP be liable to Client for
damaged or destroyed Client Production Equipment.
(i)(B) Notwithstanding anything to the contrary set forth in
subparagraph (i)(A) above, if Client Production Equipment is destroyed or
damaged by BSCP Personnel while BSCP Personnel were acting at the direction of
Client Personnel, then BSCP shall not be liable to Client for damage or
destruction occurring to Client Production Equipment.
(ii)(A) If during a Product production process, but prior to the
delivery of such Product to Client in accordance with the terms of this
Agreement, Materials are destroyed or damaged by BSCP Personnel, and such damage
or destruction resulted from BSCP's failure to execute a Product production
process in conformity with the Production Record, or failure to follow written
Client instructions as permitted by the Production Record, then, except as
provided in subparagraph (ii)(B) below, BSCP shall provide Client with
additional Product production time, without charging Client a Monthly Fee, equal
to the actual time lost because of the destruction or damage of the Materials.
(ii)(B) Notwithstanding anything to the contrary set forth in
subparagraph (ii)(A) above, if during a Product production process, but prior to
the delivery of such Product to Client in accordance with the terms of this
Agreement, Materials are destroyed or damaged by BSCP Personnel while BSCP
Personnel were acting at the direction of Client Personnel or according to
written Client instructions as permitted by the Production Record, then BSCP
shall have no liability to Client as the result of such destruction or damage.
(iii)BSCP and Client expeditiously shall attempt to resolve any
dispute regarding the liability of the parties under subparagraphs (i) and (ii)
above, as applicable, but if such dispute cannot be settled within 30 days after
the occurrence of the applicable damage or destruction, then the dispute shall
be submitted to an arbitrator located in Baltimore, Maryland, with the requisite
scientific background and training (the "Paragraph 5(f) Arbitrator"), selected
jointly by BSCP and Client. The Paragraph 5(f) Arbitrator, employing the
Commercial Arbitration Rules of the American Arbitration Association, shall
determine the cause of such failure, and the Paragraph 5(f) Arbitrator's
findings shall be final. The costs and expenses of the Paragraph 5(f) Arbitrator
shall be borne by the party which does not prevail in the arbitration
proceeding.
(iv)Client agrees that its sole remedy with respect to damaged or
destroyed Materials and Production Equipment is as set forth in this Paragraph
5(f), and in furtherance thereof, Client hereby waives all other remedies at law
or in equity regarding the foregoing.
(g) Retention of Product Samples and Standards. Upon written request
from BSCP, Client will provide samples and standards of each Product.
(h) Indemnification.
(i) Client hereby holds harmless and indemnifies BSCP, its
employees, officers, directors, shareholders, agents, and affiliates from and
against any and all claims, losses, liabilities, lawsuits, proceedings, costs,
and expenses, including, without limitation, reasonable attorneys fees, and the
cost of recalls (collectively, "Claims") resulting from, arising out of, or in
connection with, the Product, including without limitation, Claims based on
negligence, warranty, strict liability, or any other theory of product liability
or violation of any applicable laws or regulations, except to the extent that
such injuries or violations were the result of BSCP's failure to discharge its
obligations materially in accordance with this Agreement.
(ii) BSCP hereby holds harmless and indemnifies Client, its
employees, officers, directors, shareholders, agents, and affiliates from and
against any and all Claims resulting from, arising out of, or in connection
with, BSCP's failure to discharge its obligations materially in accordance with
this Agreement.
(iii) Upon receipt by a party entitled to indemnification
hereunder (an "Indemnified Party") of any notice of any Claim for which the
other party hereto (an "Indemnifying Party") is liable to provide
indemnification hereunder (an "Indemnifying Party"), the Indemnified Party will
give the Indemnifying Party written notice of the same if the Indemnified Party
intends to make a Claim against the Indemnifying Party under this Agreement;
provided, however, that the failure to provide such notice will not relieve the
Indemnifying Party from any liability to the Indemnified Party, except to the
extent that the Indemnifying Party is prejudiced by the Indemnified Party's
failure to provide such notice. The Indemnifying Party will have the right, at
its option and expense, to assume the defense or pursuit of any Claim for which
the Indemnifying Party has indemnified the Indemnified Party under this
Agreement for any actual losses, liabilities, damages, charges, liens,
deficiencies or expenses of any nature (including, without limitation,
reasonable attorneys' fees)(collectively, "Losses") incurred in connection with
such Claim or defense. The Indemnified Party will have the right to approve
(which approval will not be withheld, delayed or conditioned unreasonably)
counsel selected by the Indemnifying Party in the event the Indemnifying Party
assumes the defense of such Claim. If the Indemnifying Party has assumed the
pursuit or defense of a Claim, the Indemnified Party will have the right to
participate and assist at its own expense in the pursuit or defense of such
Claim and to employ its own counsel in connection therewith. The Indemnifying
Party will not be liable to the Indemnified Party for the fees, costs or
expenses of the Indemnified Party's counsel or other expenses incurred by the
Indemnified Party in connection with participation in or the pursuit or defense
of such a Claim after the Indemnifying Party assumes such pursuit or defense.
Notwithstanding the foregoing, in the event that the Indemnified Party, at the
request of the Indemnifying Party, incurs costs associated with investigation of
a Claim or preparation of a defense of a Claim, the Indemnifying Party will be
liable for and pay to the Indemnified Party all such costs as are reasonable.
The Indemnifying Party will not have the right to assume the pursuit or defense
of any Claim if, in the reasonable judgment of the Indemnified Party, the
Indemnified Party determines that representation of both the Indemnifying Party
and the Indemnified Party by the same counsel would be inappropriate due to
actual or potential differing interests between them or the availability to the
Indemnified Party of legal defenses that are different from or in addition to or
inconsistent with the defenses available to the Indemnifying Party. In such an
event, the Indemnified Party will have the right to retain its own counsel in
connection with such Claim and will be indemnified by the Indemnifying Party for
any and all Losses incurred in connection with investigating or defending such
Claim; provided, however, that in no event will the Indemnifying Party be liable
for the fees and expenses of more than one counsel for all Indemnified Parties
in connection with any one Claim, or in connection with separate but similar or
related Claims arising out of the same general allegation, in the same
jurisdiction. The Indemnifying Party will not be liable with respect to any Loss
arising out of or resulting from a compromise or settlement of any Claim for
which it has an indemnification obligation to the Indemnified Party without its
expressed written consent, which consent will not be withheld, delayed or
conditioned unreasonably.
(i) Limitation of Liability. Subject to the provisions of Paragraph
5(b) hereof, Client hereby agrees that to the fullest extent permitted by law,
BSCP's liability to Client for any and all injuries, claims, losses, expenses,
or damages, whatsoever, arising out of or in any way related to BSCP's
production of each Product hereunder from any cause or causes, including, but
not limited to, negligence, errors, omissions or strict liability, and
including, but not limited to, the events covered by Paragraph 5(f) hereof,
shall not exceed the total charges paid by Client to BSCP hereunder with respect
to such Product. To the extent that this clause conflicts with any other clause
in this Agreement, this clause shall take precedence over such conflicting
clause. If applicable law prevents enforcement of this clause, then this clause
shall be deemed modified to provide the maximum protection to BSCP as is
allowable under applicable law.
(j) Storage.
(i) Prior to the Commencement Date. Client shall not deliver any
Materials or other Client property to the Facility prior to 30 days before each
applicable Commencement Date. Any such Materials, equipment or other property
delivered to the Facility prior to such date may be accepted by BSCP for
storage, in its sole discretion, and if so accepted, shall be subject to a
storage charge payable by Client to BSCP from the period of acceptance until 30
days prior to the applicable Commencement Date, in accordance with BSCP's
storage rates and procedures, as set forth on Schedule E-( ) attached hereto, as
amended from time to time.
(ii) Storage After Completion of the Production Term. Any Product,
Materials, Equipment or other Client property that remain at the Facility after
completion of the applicable Production Term (the date of such completion being
called, the "Completion Date") may be stored by BSCP at the Facility upon
Client's request, without cost, for up to 30 days after notice of disposition
has been delivered to Client. If Client has not responded prior to the
expiration of such 30-day period, BSCP may, in its sole discretion, continue to
store such Product, Materials and other Client property at the Facility or
elsewhere, in which event Client shall pay to BSCP a storage charge, in
accordance with BSCP's storage rates and procedures as set forth on Schedule E-(
) attached hereto, as amended from time to time, for the period beginning on the
11th day after the notice of disposition through the date that the storage
terminates. If Product, Materials, Equipment or Client property remain at the
Facility for a period of less than 30 days, no cost shall be incurred by the
Client.
(iii) Storage During the Production Term. In the event that Client
wishes to end a Campaign, with the intent to begin a subsequent Campaign, Client
can opt to store any Product, materials, equipment or other Client property in
the Production Area subject to the Monthly Fee, or opt to remove Product,
materials, equipment, or other Client property from the Production Area. Client
is financially responsible for storage of any Product, materials, equipment or
other Client property in accordance with BSCP's storage rates and procedures as
set forth on Schedule E-( ) attached hereto, as amended from time to time.
6. Confidential Information. All confidential information communicated by
Client to BSCP, including the Production Record (collectively, "Client
Confidential Information"), shall remain the exclusive property of Client, and
shall be held in confidence by BSCP. Client shall not disclose to any third
party confidential information regarding the Facility or the identity of any
other BSCP client using the Facility, or information regarding such other
client's product, processes or operations at the Facility (collectively, "BSCP
Confidential Information"). In addition, Client Confidential Information and
BSCP Confidential Information (collectively "Confidential Information") shall
not include information that:
(a) at the time of disclosure is in the public domain;
(b) after disclosure, becomes part of the public domain, by
publication or otherwise, through no fault of the disclosing
party;
(c) at the time of disclosure is already in the disclosing party's
possession, and such prior possession can be properly demonstrated
by the disclosing party;
(d) the disclosing party receives in good faith from any third party
independent of the non-disclosing party, where the disclosing
party has no knowledge of said third party obtaining said
information by any wrongful means; or
(e) is required, in the reasonable and unqualified opinion of the
disclosing party's legal counsel, to be disclosed by operation of
the law or the requirement of a governmental agency, provided
that:
(i) the disclosing party shall have promptly notified the
other party prior to such disclosure and the disclosing
party shall have been given the opportunity to oppose
such disclosure by the disclosing party, by seeking a
protective order or other appropriate remedy,
(ii) the disclosing party shall disclose only that portion
of Confidential Information legally required to be
disclosed, and
(iii)the disclosing party will exercise all reasonable
efforts to maintain the confidential treatment of
Confidential Information.
The terms of this Agreement, any Schedule hereto, and the transactions
contemplated hereby and thereby shall not be disclosed by BSCP or Client to any
third party without the prior written consent of the other party.
7. Security Procedures. Client Personnel authorized to have access to the
Facility shall abide by the security procedures established by BSCP from time to
time. Client shall be liable for any breaches of security by Client Personnel.
In addition, Client shall reimburse BSCP for the cost of any lost security cards
issued to Client Personnel, at the rate of $50 per security card. All Client
Personnel shall agree, in writing, to abide by BSCP policies and standard
operating procedures established by BSCP from time to time.
8. Representations and Warranties .
(a) Client represents and warrants to BSCP that, to the best of its
knowledge, (i) it has the requisite intellectual property rights to each Product
and the methods required to produce it in accordance with the Production Record,
and (ii) the production by BSCP of each Product, employing the materials, the
production equipment and in accordance with the procedures set forth in the
Production Record and the Operating Documents, will not give rise to a potential
cause of action by a third party against BSCP for infringement or another
violation of intellectual property rights. Such representation and warranty
shall not apply to the production equipment supplied by BSCP.
(b) BSCP represents and warrants to Client that, to the best of its
knowledge, (i) it has the requisite intellectual property rights in its
equipment and facility to be able to perform its obligations hereunder, and (ii)
that BSCP's use of its equipment and facility as contemplated in this Agreement
will not give rise to a potential cause of action by a third party against
Client for infringement or another violation of intellectual property rights.
9. Regulatory Inspections
(a) Client will be notified of all general regulatory GMP inspections
and of all Client-specific Product regulatory GMP inspections.
(b) Client will not be permitted to participate in general regulatory
GMP inspections or non-Client specific Product regulatory GMP inspections or
teleconferences.
(c) Two Client representatives will be permitted to participate as part
of the inspection team or participate in teleconferences (Client must be at
BSCP's facility to participate in teleconferences) related to any inspections
addressed to Client and Pre-Approval inspections for Client Product that is
manufactured at BSCP's Facility. BSCP will be responsible for managing the
inspection and determining the information that will be presented to the
regulatory inspector(s) as to Facility issues and manufacturing services
performed by BSCP. Client shall be responsible for managing the inspection and
determining information that will be presented to the regulatory inspector(s) as
to Client Product specific issues and Client Product manufacturing process
specific issues.
(d) In the event that the Facility is shut-down by a governmental
agency or due to a violation of a governmental agency regulation and this
shut-down prohibits the Facility from being used for the production of the
Product, Client is not obligated to pay the Monthly Production Fee during this
period.
10. Miscellaneous.
(a) No Agency. Neither party hereto is authorized, nor shall undertake,
to bind the other party in any way as agent, partner, joint venturer or
otherwise, whether in the name of BSCP or Client or otherwise. Neither party
hereto shall refer to, display or use the other's name, corporate style,
trademarks or trade names confusingly similar thereto, alone or in conjunction
with any other words or names, in any manner or connection whatsoever, including
any publication, article, or any form of advertising or publicity, except with
the prior written consent provided by the other party. BSCP is an independent
contractor of Client, and neither BSCP nor any person or entity employed,
contracted, or otherwise utilized by BSCP for any purposes shall be deemed to be
an employee, representative or agent of Client.
(b) Force Majeure. In the event of a delay caused by inclement weather,
fire, flood, strike or other labor dispute, acts of God, acts of governmental
officials or agencies, or any other cause beyond the control of BSCP, BSCP shall
be excused from performance hereunder for the period or periods of time
attributable to such delay. There shall be no increase in compensation as a
result of any event of delay under this Paragraph 10(b) or otherwise.
(c) Condemnation. If the Facility is condemned or taken as a result of
the exercise of the power of eminent domain or shall be conveyed to a
governmental agency having power of eminent domain under the threat of the
exercise of such power (any of the foregoing being called a "Condemnation"),
Client shall be notified immediately and this Agreement shall terminate as of
the date on which title to the Facility vests in the authority so exercising or
threatening to exercise such power and Client shall not have any right to the
Condemnation proceeds.
(d) Failure to Comply with Governmental Regulations. In the event that
the facility is shut down, by a governmental agency or due to a violation of a
governmental agency regulation, and this shut-down prohibits the Facility from
being used for the production of the Product, Client is not obligated to pay the
Monthly Fee during this period.
(e) Notices. All notices, consents, waivers, and other communications
under this Agreement must be in writing and will be deemed to have been given
when (i) delivered by hand (with written confirmation of receipt), (ii) sent by
fax (with written confirmation of receipt), provided that a copy is mailed by
U.S. registered mail, return receipt requested, (iii) when received by the
addressee, if sent by a nationally recognized overnight delivery service
(receipt requested), in each case to the appropriate address and fax numbers set
forth below (or to such other addresses and fax numbers as a party may designate
by notice to the other party):
If to BSCP, to:
Bio Science Contract Production Corp.
0000 Xxxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Fax (000) 000-0000
Attention: Xxxxxxx X. Xxxxx, Chairman & CEO
If to Client, to:
Cel-Sci Corporation
0000 Xxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxx, XX 00000
Fax (000) 000-0000
Attention: Xxxxx Xxxxxxx, CEO
Any party hereto may change his or its address for notice, by giving notice
thereof in the manner herein above provided.
(f) Entire Agreement. This Agreement, including the Schedules hereto,
constitutes the entire agreement of the parties hereto with respect to the
subject matter hereof and supersedes all prior agreements and understandings,
oral and written, among the parties hereto with respect to the subject matter
hereof. The "RECITALS", "DEFINITIONS", and Schedules hereto are incorporated
herein by reference.
(g) Governing Law. This Agreement shall be governed by and construed in
accordance with the internal laws of the State of Maryland, without giving
effect to its conflicts of laws provisions. Except as provided in Paragraph 5(f)
hereof, all suits, disputes, actions, and other legal proceedings (collectively,
"Suits") related to or arising out of this Agreement, shall be brought in the
Federal District Court of the District of Maryland, which shall have the
exclusive jurisdiction over such Suits, and to the personal jurisdiction of
which BSCP and Client irrevocably submit. Process in any Suit may be served on
any party anywhere in the world.
(h) Counterparts. This Agreement and any Schedule hereto may be
executed in counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
(i) Amendments. This Agreement (including any Schedule hereto) may not
be amended or modified, and no provisions hereof may be waived, without the
prior written consent of the parties hereto.
(j) Severability. Each provision of this Agreement (and each Schedule
hereto) shall be treated as a separate and independent clause, and the
unenforceability of any one clause shall in no way impair the enforceability of
any of the other clauses herein. If one or more of the provisions contained in
this Agreement (or any Schedule hereto) shall for any reason be held to be
excessively broad as to scope, activity, subject or otherwise so as to be
unenforceable at law, such provision or provisions shall be construed by the
appropriate judicial body by limiting or reducing it or them so as to be
enforceable to the maximum extent compatible with the applicable law as it shall
then appear.
(k) Titles and Subtitles. The titles and subtitles used in this
Agreement (including any Schedule hereto) are for convenience only and are not
to be considered in construing or interpreting any term or provision of this
Agreement (or any Schedule hereto).
(l) Pronouns. Where the context requires, (i) all pronouns used herein
shall be deemed to refer to the masculine, feminine or neuter gender as the
context requires, and (ii) the singular context shall include the plural and
vice versa.
(m) Assignment. Neither party hereto shall assign this Agreement (or
any Schedule hereto) without the prior written consent of the other party,
except that BSCP shall be permitted to assign its rights and obligations
hereunder to one or more of its affiliates. Either party shall be permitted to
assign this Agreement (or any Schedule hereto) in the event of a merger between
one party and a party not bound by this Agreement, with the prior written
consent of the other party, which consent shall not be unreasonably withheld.
(n) No Lease. BSCP and Client agree that this Agreement (including any
Schedule hereto) is not a lease and the relationship between them is not that of
landlord and tenant and that BSCP retains all rights of control and possession
of the Facility, including each applicable Production Area.
(o) No Waiver. The failure of any party hereto at any time or times to
require performance of any provision of this Agreement (including any Schedule
hereto) shall in no manner affect its rights at a later time to enforce the
same. No waiver by any party hereto of the breach of any term contained in this
Agreement (including any Schedule hereto), whether by conduct or otherwise, in
any one or more instances, shall be deemed to be or construed as a further or
continuing waiver of any such breach or the breach of any other term of this
Agreement (including any Schedule hereto).
(p) Waiver of Jury Trial. BSCP and Client hereby waive trial by jury in
any suit brought by either of the parties hereto against the other or on any
counterclaim in respect thereof on any matters, whatsoever, arising out of, or
in any way in connection with, this Agreement (including any Schedule hereto).
(q) No Presumption Against Drafter. For purposes of this Agreement,
Client hereby waives any rule of construction that requires that ambiguities in
this Agreement (including any Schedule hereto) be construed against the drafter.
(r) Expenses. Except as otherwise provided in this Agreement, each
party to this Agreement will bear its respective expenses incurred in connection
with the preparation, execution, and performance of this Agreement (including
any Schedule hereto).
{signatures appear on following page}
IN WITNESS WHEREOF, the parties have executed this Agreement as of the day
and year first above written.
WITNESS: CEL-SCI CORPORATION
By: /s/ Xxxxxxxx Xxxxxxx By: /s/ Xxxxx Xxxxxxx
----------------------- ---------------------------
Xxxxxxxx Xxxxxxx Xxxxx Xxxxxxx, CEO
WITNESS: BIO SCIENCE CONTRACT PRODUCTION
CORP.
By: /s/ Xxxxxx Xxxxx By: /s/ Xxxxxxx X. Xxxxx
----------------------- ---------------------------
Xxxxxx Xxxxx Xxxxxxx X. Xxxxx, Chairman and Chief
Executive Officer
SCHEDULE A-(_1_)
TO
PRODUCTION AGREEMENT
PRODUCT DESCRIPTION
Name: Leukocyte Interleukin, Injection (MultikineTM)
----
Composition and Identification: Leukocyte Interleukin, Injection, is a natural
mixture of cytokines, and other biological response modifiers, produced in
serum-free, lectin-stimulated, culture of human peripheral blood lymphocytes.
The manufacturing intermediate further contains other proteins and peptides of
cellular origin. Human Serum Albumin, U.S.P. is added as a carrier/stabilizer.
The manufacturing intermediate is provided sterile and pyrogen free, in a 4L
sterile polypropylene container or a sterile stainless steel container, for
aseptic formulation and fill and finish by a licensed Drug manufacturer.
**********************************************
The content of this Schedule A-( 1 ) is agreed to by the parties listed below to
that certain Master Production Agreement dated as of June 19th, 2000.
CEL-SCI CORPORATION BIO SCIENCE CONTRACT
PRODUCTION CORP.
By:/s/ Xxxxx Xxxxxxx By: /s/ Xxxxxxx Xxxxx
--------------------- ----------------------
Name: Xxxxx Xxxxxxx Name: Xxxxxxx Xxxxx
Title: CEO Title: Chairman & CEO
Date: June 19, 2000
SCHEDULE B-(_1_)
TO PRODUCTION AGREEMENT
PRODUCTION TERM, SUITE AND FEES
PRODUCTION TERM
Commencement Date (the "Commencement Date"): July 1, 2000 .
Termination Date (the "Termination Date"): December31, 2000.
Production Term may be extended continuously, as needed, up to December 31,
2006. During the Production Term, if Client intends to end a Campaign, Client
must notify BSCP sixty (60) days in advance. The sixty (60) day notice
requirement is waived for the first (1st) Client Campaign. At the end of a
Campaign, Client may opt to leave all equipment in the Production Area and be
subject to the Monthly Fee or Client may opt to remove all equipment from the
Production Area and be subject to the Monthly Fee until all Client equipment is
removed from the Facility. In the event that Client decides to remove equipment
from the Production Area at the end of a Campaign, equipment may not be returned
to the Production Area to begin a subsequent Campaign for a minimum four (4)
month period. The minimum four (4) month period starts to run on the date when
Client ends a Campaign. In the event that Client wishes to return the equipment
to Production Area at the end of the four (4) month period, Client will be
subject to the Monthly Fee when the first piece of equipment is returned to the
Production Area. In the event that Client wishes to begin a subsequent Campaign,
Client must notify BSCP a minimum of one hundred twenty (120) days in advance of
the beginning of the month that Client wishes to begin a Campaign. All notice
and minimum time period requirements may be waived by mutual agreement of both
parties.
Production Area: Purification Rooms 2 & 3
FEES
Monthly Fee: $ 350,000
-------
Monthly Fee is subject to 7% increase on January 1st of each year beginning
January 1st 2002. Client may terminate this Agreement upon not less than four
(4) months notice to BSCP.
**********************************************
The content of this Schedule B-( 1 ) is agreed to by the parties listed below to
that certain Master Production Agreement dated as of June 19th, 2000.
CEL-SCI CORPORATION BIO SCIENCE CONTRACT PRODUCTION CORP.
By:/s/ Xxxxx Xxxxxxx By:/s/ Xxxxxxx Xxxxx
-------------------------- --------------------------
Name: Xxxxx Xxxxxxx Name: Xxxxxxx Xxxxx
Title: CEO Title: Chairman & CEO
Date: June 19,2000
SCHEDULE C-( 1 )
TO
PRODUCTION AGREEMENT
CLIENT-PROVIDED ITEMS
Other Client-Provided Items, if any, to be mutually agreed upon. See Schedule
D-(1).
**********************************************
The content of this Schedule C-( 1 ) is agreed to by the parties listed below to
that certain Master Production Agreement dated as of June 19th, 2000.
CEL-SCI CORPORATION BIO SCIENCE CONTRACT
PRODUCTION CORP.
By:/s/ Xxxxx Xxxxxxx By:/s/ Xxxxxxx Xxxxx
----------------------- ---------------------------
Name: Xxxxx Xxxxxxx Name: Xxxxxxx Xxxxx
Title: CEO Title: Chairman & CEO
Date: June 19,2000
SCHEDULE D-( 1 )
TO
PRODUCTION AGREEMENT
OTHER PRODUCTION REQUIREMENTS
Such rates shall be subject to change from time to time in accordance with
written notice provided by BSCP to Client. Labor rate is subject to 7% increase
on January 1st of each year beginning January 1st 2002.
PERSONNEL:
- Labor is not provided in the Monthly Fee. BSCP will provide labor at
the rate of $75.00 per hour.
- BSCP will designate a supervisor(s), at the labor rate specified above,
to support Client in conformance to BSCP policies regarding cGMP
facility and safety issues. BSCP supervisor will also serve as a liason
between the Client's management team and BSCP. Client personnel will be
under the direct supervision of Client's management team during the
Production Term. The BSCP supervisor will prevail with respect to cGMP
facility and safety issues.
- Client will be responsible for having a senior Quality Assurance
representative on-site, during all Campaigns.
HAZARDOUS WASTES AND SUBSTANCES:
Type Amount Charge for Disposal
Medical Waste N/A* N/A*
- Hazardous waste generated during a production campaign will be handled
by the Client in a manner compatible with clean room operations. Client
personnel will remove this waste from the Production Area at the end of
each workday. Client personnel will be responsible for complete removal
of the waste from the Facility. Client personnel are responsible for
handling the waste in accordance with BFI (or other accredited
hazardous waste removal contractor) guidelines.
*Disposal of medical waste will be the sole financial responsibility of
Client. If Client does not meet this obligation, hazardous waste will be
disposed of by BSCP and expenses associated with disposal will be the
responsibility of the Client.
RAW MATERIALS:
- BSCP will be responsible for purchasing raw materials, components, and
supplies used in the production of the Product. The only exceptions are
those raw materials which require a proprietary test panel. These
exceptions will be enumerated by the Client in a memorandum of
understanding, and will be considered "pre-released" by the Client.
BSCP will jointly prepare with Client, a SOP to deal specifically with
"pre-released" items. That SOP will list the items covered, storage,
sampling, testing, and release requirements. Sampling, testing and
release of items that are not "pre-released" will be coordinated
through BSCP.
- Raw materials, components, and supplies will be stored at BSCP on a
Campaign basis.
- Raw materials, components, and supplies will be stored at BSCP pursuant
to BSCP
Standard Operating Procedures ("SOP's"). SOP's will define storage
location(s) and environmental conditions.
- Raw materials, components, and supplies will be labeled with both a
BSCP Part Number and a Client Part Number. BSCP will be responsible for
providing Client with a list that relates the two part numbers
associated with each raw material, component, or supply.
- BSCP will be responsible for writing raw material specifications in its
own format. These specifications will be substantively consistent with
Client's raw material specifications in all instances. Client must
authorize all exceptions to substantive consistency in writing.
- Client will be responsible for notifying BSCP immediately of changes to
raw material specifications.
- BSCP will be responsible for notifying Client immediately of any
excursions for raw material testing that is outside of the specified
range(s).
- BSCP will be responsible for auditing contract laboratories, except
where the contractor is also a raw material supplier. If the contractor
is a raw material supplier, Client will provide audit services. BSCP
and Client will provide each other with a schedule of audit activities,
and either party may join an audit of the other party at its own
discretion. Audit reports prepared by BSCP will be distributed to
Client immediately upon release, and audit reports prepared by Client
will be distributed to BSCP immediately upon release. Client will be
responsible for all costs, including but not limited to, labor hours
and travel expenses, involved in BSCP audits of contract laboratories.
In Process/Product Materials:
- BSCP will be responsible for coordinating the collection and testing of
in-process samples. BSCP will be responsible for the dissemination of
the resulting test reports (and all applicable paperwork) to the Client
immediately upon receipt. Client will be responsible for reviewing the
resulting test reports and providing BSCP with a determination of the
Client review.
- BSCP will be responsible for shipping samples of raw materials and
in-process samples, pursuant to agreed programs between BSCP and the
Client.
FACILITY/EQUIPMENT:
- BSCP will be responsible for maintaining a schedule for preventive
maintenance, and for coordinating preventive maintenance, for all
equipment utilized in the manufacture of the Product.
- Client will be responsible for the purchase of all new equipment to be
utilized in the Production Area, including but not limited to, storage
racks and tables.
- Client will be responsible for providing equipment manuals to BSCP for
all equipment used in the manufacture of the Product.
- Client will be responsible for providing BSCP with a weekly production
schedule.
- BSCP will be responsible for installing a pass-through between
purification suites 2
& 3, an air-curtain in purification suite 3, and to upgrade the
electrical service, all as specifically approved by the Client.
- Client will be responsible for technology transfer bearing upon the
washing and packaging of components in preparation for steam
sterilization.
- BSCP will identify each piece of Client specific equipment and maintain
equipment history files.
- Client will be responsible for ensuring that equipment used for the
Product will be certified as decontaminated by the State of Maryland
and/or a Federally Accredited Contractor prior to transfer to BSCP.
Equipment logs for each piece of equipment transferred to BSCP must
accompany the equipment.
- BSCP will be responsible for providing access to two (2) Class 10,000
clean rooms (namely purification rooms 2 & 3).
- Production of the Product will be the sole responsibility of Client.
- BSCP will schedule Client's wash prep and autoclave needs based on the
weekly production schedule provided by the Client. BSCP will provide
trained personnel for the wash prep and autoclaving of Client's goods
using validated autoclave load configurations during a Campaign.
- BSCP will be responsible for providing a dedicated office for use by
the Client's Quality Assurance representative and the Client's Senior
Director of Manufacturing. BSCP will provide a second office to
accommodate up to eight (8) Client personnel. Both offices will have
electrical outlets and be equipped with desks, chairs, and storage
cabinets. Client personnel will have access to BSCP Lunch/Break room
and shower and washroom facilities.
- Equipment performance monitoring, as designated by Client, will be the
responsibility of BSCP. Initially, monitoring will be manually executed
by BSCP personnel once per shift, until an electronic monitoring system
can be identified and evaluated. A final decision and implementation of
an automatic monitoring system (e.g. Xxxx System or equivalent) will be
completed within 4 months of the commencement of this contract.
- BSCP will be responsible for installation of Client's manufacturing
equipment. In general, BSCP will perform the IQ/OQ and calibrate the
manufacturing equipment. Manufacturing Process Validation (PQ)
exercises for equipment that is utilized directly in the manufacture of
the Product, will be carried out by the Client, at its discretion. A
list of equipment installation exercises, equipment validations, and
manufacturing process validations will be prepared jointly by BSCP and
the Client. The responsible party will be designated within this list.
- BSCP will be responsible for the preparation of autoclave validation
protocols. Only client-specific validation load pattern configurations
will be subject to the approval of the Client. BSCP will be responsible
for executing the subject validations in conformance with the approved
protocol, and for reducing the resulting data and preparing a report of
these exercises.
- Client may identify suitably qualified contractors to assist with
equipment installation in and removal from the Production Area. BSCP
has the sole discretion to determine if the identified contractors are
suitably qualified. Contractors will be subject to the direction of
BSCP personnel regarding scheduling and facility policies. Client will
be responsible for all costs (including hourly labor rate) associated
with the supply of contractors. BSCP recognizes Client's interest in
temporal efficiency during equipment installation in and removal from
the Production Area.
DOCUMENTATION:
- Original copies of Client documentation required by regulation (FDC
Act) to be held for a specified period by BSCP will be held as "company
confidential." BSCP will abide by the terms of the contract for
document confidentiality, subsequent to termination. All original
copies of documentation, excluding documents that relate to BSCP
equipment, will be returned to the client upon expiration of the
relevant period of mandatory hold. BSCP retains right to keep copies of
all documentation.
- BSCP will be responsible for the reproduction and distribution of the
Client Production Record, upon receipt of a written request by one of
the client's authorized representatives.
- Client's Senior Director of Manufacturing will have the sole
responsibility for assigning Product Batch Numbers and Lot Numbers.
- Client will be solely responsible for review and approval of executed
Production Records.
- Client's Quality Assurance Department will be responsible for the
release of the Product intermediates and final Product.
- Issuance of variance, deviation, indicent, and I-CAR reports specific
to production of the Product will be the responsibility of the Client;
however, reports bearing upon environmental conditions (i.e particulate
counts, personnel monitoring etc.) and other facility matters will be
issued by BSCP.
- BSCP and Client will independently archive a copy of the released
Production Record. BSCP will provide Client with a complete copy of the
released Production Record, at the request of Client's authorized
representatives.
- Client representatives authorized to request a copy of any section of
the Production Record are Manufacturing Supervisor, Senior Director of
Manufacturing, Senior Vice-President of Research & Manufacturing,
Senior Director of Quality Assurance, Consultant for Quality Assurance
& Regulatory Affairs, and the Chief Executive Officer of Client's
Corporation. No other persons are so authorized.
- Client will be able upon request to review all
facility/utility/equipment validation, that supports Client's process,
previously conducted by BSCP and as needed in the future, under the
terms of this Agreement.
- Originals of validation documents and all other protocols or documents
developed jointly by BSCP and the Client, specifically for Client
equipment, will be the sole property of the Client. BSCP retains the
right to keep a copy of the validation documents and all other
protocols or documents developed jointly by BSCP and the Client,
specifically for Client equipment. All validation documents and all
other protocols or documents developed for BSCP equipment are the sole
property of BSCP.
- The preparation of equipment validation protocols, including Sterilizer
validation protocols, will be the responsibility of BSCP.
Responsibility for execution of validation experimental protocols, for
the accumulation of resulting raw data, and for the reduction of raw
data, will be the responsibility of BSCP. The authorization of
validation reports will be the responsibility of BSCP. Only
client-specific validation load pattern configurations will be subject
to the approval of the Client.
- All BSCP documents are confidential. Only those documents that pertain
to the Client can be freely viewed by Client employees.
LABELING:
- Client will be solely responsible for the text, purchase, receipt, and
approval of all Product labeling. Approved labeling will be transferred
to BSCP for storage as an inventory item. Client will be responsible
for requesting labels from inventory, issuance, label control and
reconciliation of all labels. BSCP name will not appear on labels.
TRAINING:
- BSCP will be responsible for providing training to Client personnel
with regard to relevant BSCP corporate, safety, facility and cGMP
policies, as appropriate.
- BSCP will provide training to Client personnel in gowning and all other
BSCP procedures that pertain to Client operations within BSCP.
MISCELLANEOUS:
- BSCP will provide disposable gowning materials for Client personnel.
Client will be financially responsible for disposable gowning
materials.
- Other issues that have not been dealt within this Agreement will be
addressed by an addendum to the Agreement between Client and BSCP.
- BSCP will provide Client with additional Product production time,
without charging Client a Monthly Fee, equal to the actual time lost if
a Product production process fails or is aborted as the result of a
failure of the BSCP plant including utilities or a critical error by a
BSCP representative.
- BSCP will provide cleaning services (for the floor, walls, and exterior
of equipment) for the two clean rooms. All trash removal in clean rooms
is the responsibility of the Client. Cleaning services (for the floors
and trash removal) for the Client offices will be available at Client
request only during occupation of the Client offices by Client
personnel.
**********************************************
The content of this Schedule D-( 1 ) is agreed to by the parties listed below to
that certain Master Production Agreement dated as of June 19th, 2000.
CEL-SCI CORPORATION BIO SCIENCE CONTRACT
PRODUCTION CORP.
By:/s/ Xxxxx Xxxxxxx By:/s/ Xxxxxxx Xxxxx
----------------------- ---------------------------
Name: Xxxxx Xxxxxxx Name: Xxxxxxx Xxxxx
Title: CEO Title: Chairman & CEO
Date: June 19, 2000
SCHEDULE E-( 1 )
TO
PRODUCTION AGREEMENT
MONTHLY STORAGE RATES AND PROCEDURES
Monthly Storage Charge:
$7.50 per square foot for Room Temperature Storage
$12.00 per cubic foot for Refrigerated Storage
$15.00 per cubic foot for Freezer Storage
Minimum Storage Charge:
$750 for Room Temperature Storage
$1,200 for Refrigerated Storage
$1,500 for Freezer Storage
Procedure:
Client will not ship any materials, equipment or supplies to BSCP without the
prior written approval of BSCP.
**********************************************
The content of this Schedule E-( 1 ) is agreed to by the parties listed below to
that certain Master Production Agreement dated as of June 19th, 2000.
CEL-SCI CORPORATION BIO SCIENCE CONTRACT
PRODUCTION CORP.
By: /s/ Xxxxx Xxxxxxx By: /s/ Xxxxxxx Xxxxx
------------------------- -------------------------
Name: Xxxxx Xxxxxxx Name: Xxxxxxx Xxxxx
Title: CEO Title: Chairman & CEO
Date: June 19, 2000
