EXHIBIT 10(z)
DEVELOPMENT, SUPPLY AND
DISTRIBUTION AGREEMENT
DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT ("Agreement") dated November
10, 2000, by and between CEL-SCI Corporation, a Colorado corporation, located at
8229 Boone Boulevard, Suite 802, Vienna, Virginia 22182, USA ("CEL-SCI"), and
Orient Europharma Co., Ltd., a corporation organized and existing under the laws
of Taiwan, R.O.C., located at 7F., No.368, Sec. 1, Fu Hsing S. Road, Taipei,
Taiwan, Republic of China ("Orient Europharma").
WHEREAS, CEL-SCI and Orient Europharma are engaged in the development and
distribution, respectively, of pharmaceutical products; and
WHEREAS, Orient Europharma has broad marketing and distribution capabilities
and regulatory expertise in the Territory (as defined) with respect to
pharmaceutical products; and
WHEREAS, Orient Europharma wishes to obtain from CEL-SCI exclusive marketing
and distribution rights in the Territory with respect to CEL-SCI's
pharmaceutical Product (as defined) manufactured and developed by CEL-SCI, and
wishes to have CEL-SCI supply it with such Product; and
WHEREAS, Orient Europharma wishes to fund the clinical trials necessary to
obtain Product registrations in the Territory; and
WHEREAS, CEL-SCI wishes to grant Orient Europharma exclusive marketing and
distribution rights for cancer indications and to supply Orient Europharma with
such Product for clinical trial use and resale in the Territory;
NOW, THEREFORE, in consideration for the mutual promises contained herein,
the parties agree as follows:
1. Definitions
As used in this Agreement, the following definitions shall apply:
a. "Commencement Date" shall mean, with respect to the Product, the
date of the first commercial sale of such Product in Taiwan. If the
Product is not approved for sale in Taiwan, then "Commencement Date"
will be the date of first commercial sale in any country of the
Territory, as acknowledged in writing by Orient Europharma and
CEL-SCI.
b. "Contract Year" shall mean a calendar year, according to the USA
calendar.
c. "FOB" shall have the meaning ascribed in the Uniform Commercial Code
in effect in Maryland, USA. "FOB point of origin" shall mean FOB at
the CEL-SCI manufacturing or packaging site or at its contractor's
site where such activities are performed, for the Product in the
USA.
d. "THA" shall mean the Taiwanese Health Authorities, or its
successors.
e. "IND" shall mean an Investigational New Drug application filed with
the U.S. or Canadian health authorities or any other national health
authority recognized by the THA in the Territory covering
manufacture of the Product dosage form(s) being evaluated in
clinical trials under such IND.
f. "Labeling" shall mean all package inserts, vial labels and carton
imprints and all other markings on packaging for, or other similar
materials related to, the Product for commercial sale that are
defined as labeling under any applicable law or regulation.
"Labeling" shall also mean such labeling applicable to the use of
clinical supplies (e.g., Investigational Drug Brochure).
g. "Manufacturing Cost" shall mean CEL-SCI's fully-burdened direct and
indirect manufacturing costs and expenses associated in producing
the Product, including, but not limited to, cost of materials,
supplies, utilities, rent, labor (including taxes, benefits,
overheads), third party contract expenses, administration,
depreciation for plant and equipment and any other direct expenses.
h. "Gross Selling Price" is (1) the national reimbursement price
approved by THA or the equivalent regulatory agency in the other
countries of the Territory, or (2) in the event that THA or the
equivalent regulatory agencies in the other countries do not grant
the approval to reimburse the payments, Gross Selling Price is the
contract price between Orient Europharma and the major hospitals in
Taiwan or other countries in the Territory.
i. "Specifications" shall mean, with respect to the Product, the
specifications set forth in the IND for such Product approved by the
health authorities in the Territory.
j. "Product" shall mean CEL-SCI's Leukocyte Interleukin Injection
(Multikine(TM)), plus any improvements thereto, which shall comply
with the Specifications, approved by health authorities in the
Territory.
k. "Purchase Price" is (1) the transfer price of Product for commercial
sale from CEL-SCI to Orient Europharma as specified in Section 9(b)
; or (2) the transfer price of Product for clinical use according to
Section 9(c).
l. "Term" shall have the meaning ascribed to it in Section 3(a) hereof.
m. "Territory" shall mean Taiwan, Singapore, Malaysia and Hong Kong.
CEL-SCI grants to Orient Europharma the right of first negotiation
with respect to Thailand, China and the Philippines.
2. Authorization and Acceptance of Distribution
a. Subject to the terms and conditions herein contained, CEL-SCI hereby
appoints Orient Europharma, following regulatory approval for sale,
as its exclusive distributor to market, distribute and sell the
Product for human cancer indications in the Territory.
b. Orient Europharma will be entitled to appoint sub-distributors for
the Territory with respect to marketing, distributing and selling
the Product and to perform any of the obligations undertaken by it
under this Agreement through any corporation or entity controlling
or under common control with Orient Europharma. These appointments
will be subject to CEL-SCI approval which approval will not be
unreasonably withheld.
3. Term
a. The term of this Agreement shall commence on the date hereof and
shall terminate on the fifteenth anniversary date of the
Commencement Date for the Product. The 15-year term may hereinafter
be referred to as the "Term."
b. After the 15-year period has expired, the exclusive Term for the
Product shall automatically be extended for successive two-year
periods unless at least six months before the expiration of the then
current period for such Product, either party gives written notice
to the other that it does not wish to extend the exclusive Term.
c. Following the expiration of the 15-year Term, with or without its
2-year extension, all rights of Orient Europharma to the Product, as
well as any discoveries, inventions, or improvements to the Product
will expire and revert to CEL-SCI. In addition, Orient Europharma
will sign over to CEL-SCI any rights that Orient Europharma may
retain in the Product (e.g. product registration in the countries of
the Territory). Orient Europharma will also return all data and/or
documents that relate to the Product. Notwithstanding anything
herein to the contrary, Orient Europharma shall have the right to
sell Product obtained from CEL-SCI hereunder in its possession after
termination of this Agreement.
4. Regulatory Approvals
a. Orient Europharma shall file substantially complete and correct
applications in all countries of the Territory where clinical trials
will be conducted.
b. Orient Europharma represents and warrants that it has, and will
maintain during the Term, all approvals necessary to conduct
clinical trials and to market, sell and distribute the Product in
the Territory, and that it may lawfully purchase such Product from
CEL-SCI, for human cancer indications.
c. After receiving from CEL-SCI all pertinent documentation required by
various regulatory authorities, Orient Europharma, at its own
expense and as promptly as possible, shall file substantially
complete and correct applications for all approvals necessary to ,
market, sell and distribute the Product in the Territory. In support
of such filings, CEL-SCI agrees to provide pertinent information and
technical assistance to Orient Europharma in seeking these
approvals. CEL-SCI shall provide to a third party chosen by CEL-SCI,
all pertinent process technology information necessary for
registration of the Product to the extent that is permitted by the
applicable laws and regulations in the Territory. The third party
will forward such information to the health authorities for the
purpose of completing the Orient Europharma application(s).
d. In addition to the provisions of Sections 4(b) and (c), Orient
Europharma shall, at its own expense and as promptly as possible,
use all due diligence to obtain all additional governmental and
other approvals which may subsequently become necessary for Orient
Europharma to import and market, sell and distribute such Product
for human cancer indications throughout the Territory.
e. Orient Europharma shall promptly provide to CEL-SCI copies, along
with English translations, of all of its product registrations and
other approvals for the marketing, distribution and sale of the
Product in the Territory. Orient Europharma shall comply with all
applicable laws in the Territory in conducting clinical studies and
in marketing, distributing and selling the Product.
f. Orient Europharma shall conduct all clinical studies required for
the registrations with the health departments in the Territory
defined in Section 1(m) of Product required in connection with the
approvals and registrations for such Product to be obtained in
accordance with Section 4(c). Orient Europharma shall bear all the
costs and expenses in conducting such studies in the Territory,
including the cost of clinical supplies of the Product from CEL-SCI,
the cost of the Clinical Research Organization (CRO), plus CEL-SCI's
expenses associated with regulatory applications. In particular,
Orient Europharma will assist CEL-SCI to conduct clinical trial(s)
of the Product in Taiwan and/or other sites within the Territory,
and shall bear all costs and expenses relating to such trial(s).
Orient Europharma will also reimburse CEL-SCI for reasonable travel
and hotel expenses of two trips per year to Taiwan for a team of
CEL-SCI representatives, business class airfare. Orient Europharma
agrees to pay for additional trips, if deemed necessary.
g. CEL-SCI will design and direct the clinical trials in the Territory
through an internationally recognized CRO, at Orient Europharma's
expense.
h. All preclinical and clinical data generated in the Territory shall
belong to CEL-SCI for CEL-SCI's use in Product registrations outside
the Territory.
k. Orient Europharma shall be subject to meeting certain milestones in
any country in the Territory:
(1) Start clinical trial(s)* 2001
(2) Start Phase III trials** 2002
(3) Start Phase III trials*** 2003
* of squamous cell carcinoma of the oral cavity (SCC) and
adenocarcinoma of the nasal pharynx (ANP).
** of SCC
*** of ANP, if supported by data.
If Orient Europharma fails to meet any milestone, through no fault
of CEL-SCI, CEL-SCI will have the right to re-negotiate or terminate
this Agreement.
5. Manufacturing and Packaging of Product
a. CEL-SCI will manufacture the Product and deliver as finished Product
suitable for use in clinical trials and subsequently for sale or in
bulk where the country allows.
b. Orient Europharma will provide label copy to be used on vials and
patient packs in all cases where English is not acceptable.
c. Orient Europharma shall be responsible for ensuring the accuracy of
the information and the form of the Labeling for the Product and
their compliance with applicable laws within the Territory.
d. Orient Europharma may market, sell and/or distribute the Product
under the trademark owned or used by CEL-SCI (e.g., Multikine(TM)).
Upon Orient Europharma's request, CEL-SCI shall license Orient
Europharma to use its trademark in the Territory. Orient Europharma
may market, sell and/or distribute the Product in the Territory
under any trademark owned or used by it as it may from time to time
choose. Such trademarks shall become the sole property of CEL-SCI.
6. Shipments of Product for Clinical Trials
a. CEL-SCI will ship, for use in all clinical trials in the Territory,
clinical supplies (investigational drug) necessary to support
clinical trials.
b. CEL-SCI will invoice Orient Europharma for all clinical supplies, at
CEL-SCI cost according to Section 9(c), as well as all shipping
costs including customs, storage, and insurance. Payment will be due
in 30 days from date of invoice.
7. Supply of the Product for Commercial Sale
a. No later than six months prior to the first day of each Contract
Year of the Term, Orient Europharma will provide to CEL-SCI a
non-binding forecast of Orient Europharma's annual requirements of
the Product for the succeeding Contract Year. CEL-SCI shall advise
Orient Europharma within thirty (30) days of its receipt of such
forecast of CEL-SCI's anticipated ability to supply the forecasted
amount for the applicable period (such confirmed amount, the
"Forecasted Amount").
b. If at any time during the Term, CEL-SCI is or expects that it will
be unable to satisfy the Forecasted Amount of Product for any period
of a Contract Year, in full or in part, CEL-SCI shall so notify
Orient Europharma promptly, detailing the extent to which it will
not meet such Forecasted Amount.
c. It shall be the responsibility of CEL-SCI to maintain reasonably
adequate manufacturing capabilities of the Product, using its
reasonable commercial best efforts to supply the Forecasted Amounts.
d. CEL-SCI will be the exclusive and sole supplier of Product to Orient
Europharma during the Term of this Agreement.
8. Shipment of Product for Commercial Sale
a. Orient Europharma shall place all orders for Product by delivering
to CEL-SCI a written purchase order specifying the Product, quantity
and delivery date (which delivery date shall not be less than 180
days after the date such purchase order is delivered to CEL-SCI).
b. After accepting any written purchase order, CEL-SCI shall use
reasonable commercial efforts to fill each order by the specified
delivery date and shall notify Orient Europharma of anticipated
delays in filling any order.
c. With each shipment of Product to Orient Europharma hereunder,
CEL-SCI shall invoice Orient Europharma for the Product included in
such shipment at the Purchase Price as set forth in Section 9(b).
Payment shall be made in U.S. dollars, by Confirmed Irrevocable
Letter of Credit from an internationally recognized bank to
CEL-SCI's US bank.
d. Product shall be shipped FOB point of origin. Orient Europharma
shall arrange for the carrier or shipping agent to transport each
shipment of Product from CEL-SCI's loading dock at the point of
origin to desired destination. Orient Europharma will ensure that
adequately monitored freezer (-20(Degree)C +/- 3(Degree)C) space is
maintained for Product storage prior to its distribution. Orient
Europharma shall arrange for carrier / shipment of Product to
maintain frozen condition.
9. Purchase Price
a. Both parties agree that the selling price for the Product that
Orient Europharma may market, distribute and sell in the Territory
shall be calculated in accordance with the formula set forth in
Paragraph 9(b) unless agreed by both parties to negotiate in good
faith a mutually acceptable adjustment to the Purchase Price.
b. The Purchase Price of Product for commercial sale shall be set at
35% of Orient Europharma's Gross Selling Price in the Territory.
However, if this price is ever less than CEL-SCI's Manufacturing
Cost plus 50%, the parties will then negotiate, in good faith, a
mutually acceptable Purchase Price.
c. The Purchase Price of clinical supplies (investigational drug) shall
be at $400/vial, where each vial contains 2.2 mL of Product at a
concentration of 400 IU IL-2 equivalent/mL. Starting January 1,
2002, this price will increase at 5% per year.
d. Orient Europharma will purchase 12-month minimum quantities of
Product from CEL-SCI, unless CEL-SCI is not able to supply these
quantities, starting with the Commencement Date. Minimum quantities
cannot include clinical supplies.
Year 1 $ 700,000
Year 2 $ 1,400,000
Year 3 $ 2,100,000
Year 4 $ 3,000,000
Years 5-15 $ 4,000,000
If Orient Europharma fails to meet these minimums, this Agreement will
become non-exclusive, at CEL-SCI's option.
10. CEL-SCI's Warranty and Liability
a. CEL-SCI warrants and guarantees that, prior to Orient Europharma
taking possession, upon delivery FOB point of origin, the Product
shall meet the Specifications and shall not be adulterated or
misbranded as required by the health authorities within the
Territory ("Warranty").
b. CEL-SCI will provide Orient Europharma with a Certificate of
Analysis for each shipment of Product, stating test results and the
Specifications for such shipment of Product.
c. Other than as in the specifications provided for in this Agreement,
CEL-SCI makes no other warranties with respect to the Product.
CEL-SCI does not make any implied warranties with respect to the
effectiveness of this Product.
d. CEL-SCI shall indemnify, defend and hold harmless Orient Europharma
from all actions, losses, claims, demands, damages, costs, and
liabilities to which Orient Europharma is or may become liable
insofar as they arise out of, or in connection with, any breach by
CEL-SCI of any of its obligations or Warranty under this Agreement.
11. Regulatory Compliance
a. It shall be the responsibility of CEL-SCI to ensure that the Product
sold by CEL-SCI to Orient Europharma pursuant hereto meets the
Specifications at the time of delivery to Orient Europharma FOB
point of origin.
b. Orient Europharma shall comply with all applicable laws in the
Territory with respect to packaging, marketing, distributing,
selling, promoting and advertising the Product in the Territory.
12. Representations, Warranties and Covenants
a. Orient Europharma and CEL-SCI represent and warrant to each other
that each party has all requisite corporate power and authority to
enter into this Agreement and to consummate the transactions
contemplated hereby.
b. CEL-SCI further represents, warrants and covenants that:
i) The Product sold to Orient Europharma hereunder does not
infringe any patent or third party rights in the United States
and the Territory related to the manufacture of the Product; and
ii) CEL-SCI possesses good title to the Product sold to Orient
Europharma hereunder; and
iii) CEL-SCI will not market, distribute or sell, to any party other
than Orient Europharma, the Product in the Territory except as
provided for by this Agreement; and
iv) This Agreement shall be binding upon either party's lawful
successors and assigns without changing any terms and conditions
hereof.
c. Orient Europharma represents, warrants and covenants that the
distribution and sale of the Product, as supplied under this
Agreement, shall not violate or infringe any valid trademark, patent
and/or copyrights held by third parties within the Territory.
d. Orient Europharma represents that it does not have an agreement with
another company for sale or distribution of anticancer cytokine
drugs.
13. Protection Rights
a. Except as otherwise provided by this Agreement, CEL-SCI shall not
grant any third party the right to sell, ship and/or distribute
the Product to any person or entity outside the Territory who
CEL-SCI knows intends to sell, ship and/or distribute the Product
(in bulk or dosage form) in or to the Territory for human cancer
indications. In the event CEL-SCI becomes aware during the time
that Orient Europharma has exclusive rights pursuant to this
Agreement, that any third party with whom CEL-SCI contracts to
distribute Product outside the Territory is selling or
distributing Product in the Territory directly or indirectly,
CEL-SCI shall promptly advise such third party to cease selling
and distributing Product in the Territory. In the event that such
third party continues to sell or distribute Product in the
Territory following such notice, CEL-SCI shall commence legal
action against such party to terminate such activity.
b. During the Term of this Agreement, Orient Europharma shall not
directly or indirectly manufacture, develop, ship, market, sell or
distribute any immunotherapeutic product that competes with Product
in the Territory for the indications of head & neck cancer,
adenocarcinoma of the nasal pharynx or cervical cancer. In addition,
Orient Europharma shall not directly or indirectly manufacture,
develop, ship, market, sell or distribute any product that is a
cytokine mixture, for any indication.
c. Orient Europharma shall not directly or indirectly manufacture,
develop, ship, market, sell or distribute Product outside the
Territory.
d. If there are any new discoveries, inventions, patents, or other
intellectual property as the result of this Agreement, CEL-SCI shall
own such intellectual property.
14. Confidentiality
a. Any information pertaining to the Product and/or the respective
operations of the parties that has been or will be communicated by
CEL-SCI to Orient Europharma or by Orient Europharma to CEL-SCI,
including, without limitation, trade secrets, business methods, and
pricing, cost, supplier, manufacturing and customer information,
shall be treated by CEL-SCI and Orient Europharma respectively, and
their respective affiliates, employees and agents, as confidential
information and shall not be used or revealed to third parties
except as necessary in connection with the performance of their
respective obligations hereunder; provided, however, that such
confidential information shall not be subject to the restrictions
and prohibitions set forth in this section to the extent that such
confidential information:
i) is available in the public literature or otherwise in the public
domain, or after disclosure by one party to the other becomes
public knowledge through no fault of the party receiving such
confidential information;
ii) was known through legitimate means to the party receiving such
confidential information prior to the receipt of such
confidential information by such party from the disclosing
party, as evidenced by such receiving party's written records,
whether received before or after the date of this Agreement;
iii) is obtained in good faith by the party receiving such
confidential information from a source other than the party
supplying such confidential information who was not under an
obligation of confidence or secrecy to either party at the time
of such disclosure; or
iv) is required to be disclosed pursuant to:
(A) any order of a court having jurisdiction and power to order
such information to be released or made public (with prior
notice to the disclosing party and opportunity to contest by
such party to the extent legally possible); or
(B) any lawful action of a governmental or regulatory agency
(with prior notice to the disclosing party and opportunity
to contest by such party to the extent legally possible); or
v) is required to be disclosed to a prospective, bona fide
purchaser of the shares or assets of either party hereto,
provided all such prospective purchasers agree in writing to be
bound by the standards of confidentiality.
b. Each party shall take all such precautions as it normally takes with
its own confidential information to prevent any improper disclosure
of such confidential information to any independent third party;
provided, however, that such confidential information may be
disclosed within the limits required to obtain any authorization
from the Taiwanese authorities or any other governmental or
regulatory agency in the Territory or, with the prior written
consent of the other party, which shall not be unreasonably
withheld, as may otherwise be required in connection with the
purposes of this Agreement.
15. Force Majeure
If either Orient Europharma or CEL-SCI shall be delayed, hindered,
interrupted in or prevented from the performance of any of its
obligations hereunder (other than the obligation to pay monies) by
reason of force majeure ("Force Majeure"), including, without
limitation, fire, earthquake, flood or other acts of God, strike,
lockouts, war (declared or undeclared), civil disturbances, embargo,
riots, unavailability of essential materials or transportation
facilities, orders of any governmental authority (not caused by a
default or other action of the party invoking such Force Majeure) or
other similar events beyond the control of such party, such party shall
not be liable to the other for damages, and the time for performance of
such obligation shall be extended for a period of time equal to the
duration of the contingency which occasioned such delay, hindrance,
interruption or prevention. Orient Europharma understands that the
Product is difficult to manufacture and test. Therefore, Orient
Europharma understands that there may be manufacturing problems, due to
reasons outside of CEL-SCI's control, where CEL-SCI may not be able to
supply the Product in a timely manner. CEL-SCI will make best efforts to
minimize any delay or interruption in supply.
16. Termination
a. This Agreement may be terminated in its entirety immediately upon
written notice of termination given by:
i) The non-defaulting party in the event that the other party
shall:
(A) commit a material breach or default under this Agreement,
which breach or default shall not be remedied within sixty
(60) days after the receipt of written notice thereof by the
party in breach or in default; or
(B) have made a material misrepresentation of any representation
or warranty contained herein;
ii) Either party in the event that any free trade agreements
affecting the countries, is abrogated, amended or modified so as
to materially and adversely affect the commercial benefits
inuring to either party under this Agreement as in effect on the
date hereof;
iii) Either party if the other party ceases to function as a going
concern or if proceedings in bankruptcy or insolvency are
taken against the other party and not remedied within thirty
(30) days or if its property or business or its shares be
confiscated or expropriated by any government or subdivision
thereof;
iv) By CEL-SCI if Orient Europharma fails to meet any milestone
specified in Section 4(k).
b. If this Agreement terminates prior to the expiration of the 15-year
Term, through no fault of either party, then Orient Europharma shall
be compensated for its documented Multikine clinical trial expenses
according to the following formula:
C = clinical trial expenses x
where C is the amount to be paid to Orient Europharma,
and y is the Contract Year.
17. Indemnification
a. CEL-SCI shall indemnify and hold harmless Orient Europharma and its
affiliates, successors and permitted assigns and their respective
officers, directors, stockholders, partners and employees from and
against any claim, action, suit, proceeding, loss liability, damage
or expense (other than special or consequential damages but
including reasonable attorneys` fees and expenses) arising from or
related to (i) any material breach of any representation, warranty
or covenant made by CEL-SCI hereunder, including without limitation
any failure to manufacture the Product in conformity with the
Warranty and (ii) any negligent storage or handling of Product by
CEL-SCI or its employees prior to Product transfer to Orient
Europharma (delivery to Orient Europharma FOB point of origin).
b. Orient Europharma shall indemnify and hold harmless CEL-SCI and its
affiliates, successors and permitted assigns and their respective
officers, directors, stockholders, partners and employees from and
against any claim, action, suit, proceeding, loss liability, damage
or expense (other than special, incidental or consequential damages,
but including reasonable attorneys` fees) arising from or related to
(i) any material breach of any representation, warranty or covenant
made by Orient Europharma hereunder, (ii) the storage, handling, use
or sale of Product following delivery Orient Europharma FOB point of
origin, or (iii) packaging instructions provided by Orient
Europharma.
18. Customer Complaints; Recall
a. Pursuant to the United States Code of Federal Regulations Title 21
Section 314.80 , as the same may be amended from time to time,
regarding the reporting of adverse drug experiences, Orient
Europharma shall immediately report to CEL-SCI any information
concerning adverse drug experiences associated with the use of
Product, whether or not considered drug-related, and including but
not necessarily limited to: an adverse event occurring in the course
of the use of Product in clinical trials, or in professional practice;
an adverse event occurring from overdose, whether accidental or
intentional; or any significant failure of expected pharmacological
action. Additionally, reports of routine adverse drug experiences
shall be summarized and exchanged between the parties once per
calendar year. Orient Europharma shall report potentially serious or
unexpected adverse drug experiences as defined in Title 21, Section
314.80, as amended, to CEL-SCI as soon as possible, but in no event
later than three (3) days after initial receipt of the information by
Orient Europharma and shall maintain a record of each such experience
as required under Title 21, Section 314.80(c)(iii). Orient Europharma
agrees to cooperate with CEL-SCI in arriving at a mutually acceptable
course of action regarding the handling of such information; however,
nothing contained herein shall be construed as restricting the right
or duty of either party to report the information to the appropriate
regulatory bodies.
b. In the event of any recall of Product, as suggested or requested by
any governmental authority, or any recall to which both parties
agree in writing, Orient Europharma shall perform the recall, and
the reasonable documented costs thereof, including CEL-SCI`s and
Orient Europharma's respective costs of manufacturing and
distributing the Product recalled, will be borne by CEL-SCI or by
Orient Europharma if said recall can be attributed to Orient
Europharma's fault.
19. Best Efforts
Orient Europharma shall use the same diligent efforts to develop,
register, market, sell and distribute the Product in the Territory as
with its own products or other licensed products.
20. Patent & Trademark Ownership
CEL-SCI will maintain ownership of its Product patents, trademarks
and know how and is responsible for maintaining, prosecuting and
defending these patents and trademarks in the Territory.
21. Notices
Any notice or request required or permitted to be given under or in
connection with this Agreement shall be in writing in the English
language and shall be deemed to have been duly given on the date of
delivery if delivered personally, by confirmed facsimile or by courier
on the party to whom such notice or request is to be given, or, if sent
by certified or registered mail, or the equivalent, postage prepaid, on
the tenth (10th) day after the date mailed, to the address set forth for
such party below or such other address as directed in writing from time
to time:
If to CEL-SCI:
CEL-SCI Corporation
8229 Boone Boulevard, Suite 802
Vienna, Virginia 22182
U.S.A.
FAX:(703) 506-9471
Attention: Mr. Geert Kersten, Chief Executive Officer
If to Orient Europharma:
Orient Europharma Co., Ltd.
7F, NO. 368, Sec.1
Fu-Hsing S. Road
Taipei, Taiwan, R.O.C.
FAX: 886-2-7024324
Attention: Mr. Peter Tsai, President
22. Governing Law; Arbitration
The formation, validity, construction and performance of this
Agreement shall be governed by the laws the Commonwealth of Virginia,
USA. All disputes arising in connection with this Agreement shall be
finally settled by binding arbitration under the Rules of Arbitration of
the International Chamber of Commerce by one or more arbitrators
appointed in accordance with said Rules. Any such arbitration shall be
conducted in English. The arbitration shall take place in Virginia, USA.
The judgment of the arbitration shall be final and binding to both
parties.
23. Miscellaneous
23.1 Entire Agreement
This Agreement constitutes the entire Agreement between the parties
relating to the subject matter hereof, and supercedes all prior
agreements and understandings, oral or written between the parties
with the exception of the Confidential Disclosure Agreement executed
on August 21, 2000. Any change to this Agreement must be in writing
and signed by an authorized officer of each party, and specifically
state that it is an amendment to this Agreement.
23.2 Product Improvements
During the Term of this Agreement, Orient Europharma will have
rights to improvements to the Product at no additional cost.
23.3 Independent Contractors
Each party is an independent contractor under this Agreement.
Neither party is an agent, partner or legal representative of the
other.
23.4 Late Payments
All amounts due and owing to a party under this Agreement that are
not paid by the other party when due shall bear interest at the rate
of 1 1/2% per month, or if lower, the maximum rate allowed by law,
in either case calculated from the date the amount was first due.
23.5 Withholding Taxes
Payments to CEL-SCI shall be made without deduction other than such
amount (if any) as Orient Europharma is required by law to deduct or
withhold. Orient Europharma shall obtain a receipt from the relevant
taxing authorities for all withholding taxes paid and forward such
receipts to CEL-SCI to enable CEL-SCI to claim any tax credits for
which it may be eligible. Orient Europharma shall use reasonable
efforts to minimize such withholdings and to assist CEL-SCI to claim
exemption from withholdings under any double taxation treaty or
similar agreement.
23.6 Export Law Compliance
Orient Europharma understands that the Product and other materials
may be subject to the export regulations of the US Department of
Commerce or other US regulations related to the export of drugs.
Orient Europharma represents that it is familiar with and agrees to
comply with all such regulations. Orient Europharma agrees that it
will not export or reexport outside of the Territory, directly or
indirectly, any Product, clinical supplies or clinical data relating
to the Product without prior written consent of CEL-SCI. Orient
Europharma agrees to obtain the same agreement from each of its
subdistributors in the Territory.
23.7 Government Inquiries
Each party shall promptly advise the other of any governmental
inquiries about the Product and shall furnish to the other party,
within five days of receipt, any report or correspondence issued by
the governmental authority in connection with such inquiry, purged
only of trade secrets.
23.8 Publicity
The parties agree that news releases, public announcements (written
or oral), professional publications or any publicity relating to
this Agreement, including the initial announcement of the Agreement,
clinical results, regulatory filings and marketing approvals of the
Product in the Territory, shall be mutually agreed by the parties,
such approval not to be unreasonably withheld. Notwithstanding this
Section 23.8, CEL-SCI may disclose, without approval from Orient
Europharma, any information, including confidential information (1)
required by law or regulation (including, without exception, in
connection with filings with the US Securities and Exchange
Commission); (2) in response to a valid order of a court or other
governmental body of the US or any country in the Territory or of
any political subdivision thereof; (3) otherwise required by
applicable laws; (4) otherwise necessary to file or prosecute patent
applications, prosecute or defend litigation or otherwise enforce
obligations under this Agreement; or (5) required by authorities,
investigators, or Institutional Review Boards in conjunction with
performing clinical development programs, provided that the
receiving party shall use reasonable efforts to restrict disclosure
and to cause such authorities, investigators or IRBs not to disclose
the information to any third party.
23.9 Records
With respect to the Gross Selling Price of Product sold in the
Territory, if Gross Selling Price falls under definition 1 h (2),
then Orient Europharma will, upon request and subject to
confidentiality, provide to CEL-SCI copies of the contracts between
the major hospitals and Orient Europharma showing price provisions.
If these copies are in Chinese, Orient Europharma will translate the
price provisions into English, if necessary. CEL-SCI shall have the
right to these records during the Term of this Agreement and this
right shall expire six months following termination or expiration of
this Agreement.
23.10 Surviving Obligations
Termination or expiration of this Agreement shall not relieve either
party of its obligations under Sections 4(h), 13(d), 14, 17, 18, 20,
22 and 23.5, 23.9.
IN WITNESS HEREOF, the parties hereto have executed this Agreement as of
the day and year first above written.
Orient Europharma Co., Ltd. CEL-SCI Corporation
By: /s/ Peter Tsai By: /s/ Geert Kersten
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Peter Tsai Geert Kersten
President Chief Executive Officer