PMC SUPPLY AGREEMENT
This Agreement (the "Agreement") is entered into as of August 1, 1998
by Connaught Laboratories Limited, a company incorporated under the laws of
Ontario, Canada, with its principal place of business in Xxxxx Xxxx, Xxxxxxx,
Xxxxxx ("CLL" and, together with its Affiliates, "PMC"), and Aphton Corporation,
a Delaware corporation, with its principal executive office in Miami, Florida,
USA ("Aphton").
W I T N E S S E T H :
WHEREAS, Aphton owns or controls certain patents, patent applications
and proprietary information relating to its therapeutic cancer vaccine
("Gastrimmune(TM)") and Aphton have entered into a Co-Promotion Agreement and
License dated as of February 14, 1997 (the "Marketing License"), which provides,
among other things, that PMC will have certain rights to co-promote, market,
distribute and sell Gastrimmune(TM) in Europe and North America;
WHEREAS, PMC manufactures diphtheria toxoid and tetanus toxoid;
WHEREAS, Section 3.1(c) of the Marketing License provides that Aphton
and PMC will enter into a supply agreement to provide for a supply of PMC's
diphtheria toxoid and/or its tetanus toxoid to Aphton for inclusion in products
(including but not limited to Gastrimmune(TM)) developed by Aphton.
NOW, THEREFORE, the parties hereto agree as follows:
1. DEFINITIONS
Unless otherwise defined in this Agreement, capitalized terms shall
have the meaning set forth in the Marketing License.
1.01 "Affiliate" shall mean, with respect to any Person, (i) any other
Person of which the securities or other ownership interests representing fifty
percent (50%) or more of the equity or fifty percent (50%) or more of the
ordinary voting power or fifty percent (50%) or more of the general partnership
interests are, at the time such determination is being made, owned, Controlled
or held, directly or indirectly, by such Person, or (ii) any other Person which,
at the time such determination is being made, is Controlling, Controlled by or
under common Control with, such Person. As used herein, the term "Control,"
whether used as a noun or verb, refers to the possession, directly or
indirectly, of the power to direct, or cause the direction of, the management or
policies of a Person, whether through the ownership of voting securities, by
contract or otherwise.
1.02 "Aphton Supply Agreement" shall mean the Aphton Supply Agreement
of even date herewith between Aphton and PMC.
1.03 "Bulk Material" shall mean DT and/or IT, as the case may be, in
each case as set forth in the Specifications.
1.04 "Causative Agent" shall mean any virus, bacterium, fungus,
parasitic agent or microorganism which is directly or indirectly responsible for
causing the applicable disease.
1.05 "Covered Products" shall mean, collectively, the Existing
Products, the PMC Option Products and the Declined Products, and "Covered
Product" shall mean any of them. In addition, the term "Covered Product" shall
include products in the research and development phase (whether such research
and development is being performed by Aphton itself, or by a Third Party
pursuant to a contract research or development arrangement in which such Third
Party obtains no contractual rights to any product which results from such
research or development work) which have not yet been offered to PMC pursuant to
Section 2.03 hereof.
1.06 "Declined Product" shall mean a product developed by Aphton
(either alone or in collaboration with a third party) to which, after compliance
by Aphton with Section 2.03 hereof, PMC does not obtain rights.
1.07 "DT" shall mean PMC's diphtheria toxoid.
1.08 "DT/TT-Based Product" shall have the meaning set forth in Section
2.03.
1.09 "Existing Products" shall mean, collectively, anti-gonadatropin
releasing hormone products, anti-gastrin products, and anti-chorionic
gonadatropin products.
1.10 "IND" means an Investigational New Drug application.
1.11 "Index" shall mean the Industrial Product Price Index -
Pharmaceutical and Medicine Industry, Index No. D694150, produced by Statistics
Canada, or any successor index.
1.12 "Legal Requirements" shall mean all laws, statutes, ordinances,
codes, rules, regulations, published standards, permits, judgments, decrees,
writs, injunctions, rulings, orders and other requirements of all Public
Authorities.
1.13 "Person" shall mean any natural person, corporation, firm,
business trust, joint venture, association, organization, company, partnership
or other business entity, or any government, or any agency or political
subdivision thereof.
1.14 "Phase I" shall mean a clinical trial in which a
biopharmaceutical product is administered to a limited number of subjects to
test the product's safety.
1.15 "Phase II" shall mean a clinical trial in which a
biopharmaceutical product is administered to a limited number of subjects to
determine dose ranges and efficicacy.
1.16 "Phase III" shall mean a clinical trial in which a
biopharmaceutical product is administered to a large number of subjects to
determine safety and efficacy.
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1.17 "PMC Option Product" shall mean a product to which PMC acquires
rights in accordance with the procedure set forth in Section 2.03 hereof.
1.18 "Public Authority" shall mean any supranational, national,
regional, state or local government, court, governmental agency, authority,
board, bureau, instrumentality or regulatory body.
1.19 "Specifications" shall mean the specifications for the Bulk
Material attached hereto as Exhibit A, as amended from time to time by the
parties.
1.20 "Third Party" shall mean any Person which is not an Affiliate of
any party hereto.
1.21 "TT" shall mean PMC's tetanus toxoid.
2. SUPPLY OF BULK MATERIAL
2.01 Subject to Section 2.02 hereof, PMC agrees to manufacture (or
have manufactured) and supply, and Aphton agrees to purchase, such amounts of
Bulk Material for use in Covered Products as Aphton may from time to time order
in accordance with the terms of this Agreement; provided that under no
circumstances shall Aphton (i) use (or permit to be used) any Bulk Material in
any product for sale anywhere in the world unless such product is approved by
the U.S. F.D.A. Center for Biological Evaluation and Response (CBER), or any
successor agency or department, for investigational use or sale in the United
States (or by a similar regulatory agency in the European Union, Canada or
Japan), (ii) sell, supply, transfer or otherwise provide to any Third Person any
DT or TT supplied to Aphton hereunder unless such DI or TT is to be used in a
research and development program relating to a Covered Product, (iii) use (or
permit to be used) any Bulk Material in any vaccine or other product which is
not a Covered Product, or (iv) use (or permit to be used) any Bulk Material in
any vaccine against any infectious disease Causative Agents (other than any
vaccines against infectious disease Causative Agents which are Existing
Products).
2.02 In the event that the available quantities of Bulk Material are
limited due to an Event of Force Majeure (as defined in Section 12.08 hereof),
PMC shall notify Aphton of such shortage as soon as possible and shall allocate
to Aphton a pro rata share of the amount of Bulk Material available to PMC from
PMC's DT and/or TT manufacturing facility, or facilities, as applicable (or
contract manufacturer or manufacturers, as applicable), based upon the number of
grams of Bulk Material reflected in the applicable Forecast in comparison to the
total number of grams of Bulk Material reflected in the approved annual budget
of PMC, subject to verification by Aphton in accordance with Section 4.02
hereof.
2.03 In the event that Aphton develops (either alone, with an
Affiliate or with a Third Party) any new products (other than any new products
which are vaccines against infectious disease Causative Agents, in connection
with which Aphton may not under any circumstances use any DT or TT, pursuant to
Section 2.01 hereof) in connection with which Aphton desires to use any Bulk
Material in the manufacture of the final, licensed product (each, a "DT/TT-Based
Product"), then promptly following the date on which Aphton decides to use Bulk
Material with such new product (which shall be no earlier than the filing of an
IND in respect of such DT/TT-Based Product and no later than commencement of
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preparation of clinical lots of such DT/TT-Based Product for Phase III clinical
trials), Aphton shall offer such product to PMC (the "Offer"). Aphton shall,
concurrently with the Offer, (i) make available to PMC all data and information
relating to such DT/TT-Based Product which exists as of the date of the Offer,
and (ii) provide a written representation to PMC that all Phase I and Phase II
testing has been completed and that all data resulting therefrom in Aphton's
possession or of which Aphton is aware has been made available to PMC. PMC shall
have three (3) months from the date such product is offered by Aphton (and all
such information is received by PMC) to determine whether it wishes to commence
negotiations with respect to obtaining rights to such DT/TT-Based Product. If
PMC wishes to commence such negotiations, PMC and Aphton negotiate in good faith
and exclusively for a period of sixty (60) days the terms under which PMC will
obtain such rights. In the event that, at the end of such sixty (60) day period,
PMC and Aphton are unable in good faith to agree on fair and commercially
reasonable terms under which PMC will obtain rights to develop and/or market
such product, Aphton shall be free to use Bulk Material supplied hereunder in
connection with such DT/TT-Based Product (and such DT/TT-Based Product shall
constitute a Declined Product for the purposes of this Agreement); provided,
that Aphton shall not be permitted to grant to any Third Party any rights to
develop and/or market such DT/TT-Based Product on terms which are less favorable
to Aphton than PMC's final offer made in connection with the Offer and the
subsequent negotiations. If at any time Aphton wishes to grant rights to any
Third Party to develop and/or market such DT/TT-Based Product on terms which are
less favorable to Aphton than those offered by PMC, Aphton shall first confirm
if PMC's final offer is still open. In connection therewith, Aphton shall
provide to PMC all clinical data which has been generated in respect of such
DT/TT-Based Product and which has not previously been made available to PMC
(along with a written representation from Aphton that all such clinical data has
been provided to PMC). PMC shall thereafter have thirty (30) days to confirm or
withdraw its final offer. If PMC confirms its final offer, Aphton and PMC shall
promptly execute and deliver appropriate binding written agreements which
reflect such offer. If PMC withdraws its final offer, Aphton shall be free to
enter into an agreement with such Third Party on such less favorable terms. If
PMC and Aphton enter into an agreement under which PMC obtains rights to develop
and/or market such DT/TT-Based Product, such product shall constitute a PMC
Option Product for the purposes of this Agreement. In order to ensure that PMC
can exercise the rights provided for hereunder, Aphton agrees not to enter into
any agreements or understandings, whether oral or written, pursuant to which a
Third Party will acquire rights to market any DT/TT-Based Product, either alone
or through an arrangement in which Aphton participates, which would preclude PMC
from obtaining exclusive marketing rights to such DT/TT-Based Product upon
acceptance of an Offer.
3. FORECASTS AND ORDERS FOR BULK MATERIAL
3.01 PMC will supply, and Aphton will purchase from PMC, quantities of
Bulk Material determined in accordance with the procedures set forth in this
Article 3.
3.02 At the reasonable request of Aphton from time to time until
December 31, 1998, PMC will supply, and Aphton will purchase from PMC,
reasonable quantities of Bulk Material in accordance with the terms and
conditions of this Agreement.
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3.03 Beginning on September 30, 1998 (for the period beginning January
1, 1999) and every three months thereafter for so long as this Agreement shall
remain in effect, Aphton shall provide PMC with a rolling nine-month forecast of
its requirements for Bulk Material (each, a "Forecast"), which Forecast must
specify (i) the number of grams of DT and/or TT, as applicable, (ii) the amount
of such Bulk Material which shall constitute Art. 6 DT/TT (as defined in the
Marketing License) and (iii) if any quantities are specified, at least
[Redacted]* grams of Bulk Material must be specified. The quantities specified
in each Forecast (i) in respect of the first three month period covered thereby,
shall constitute an irrevocable, firm order (a "Firm Order") as to the
quantities of Bulk Material, the delivery dates and the delivery locations
specified therein, (ii) in respect of the second three month period covered
thereby, shall constitute a Firm Order as to the quantities of Bulk Material
specified therein, and (iii) in respect of the third three month period covered
thereby, shall constitute a non-binding estimate; provided that such quantities
do not exceed [Redacted]* grams per annum in the aggregate. No quantities in
excess of [Redacted]* grams per annum in the aggregate will constitute a Firm
Order if PMC has notified Aphton (within ninety (90) days of the receipt of the
applicable forecast) that the annual DT and/or TT manufacturing capacity, as
applicable, of its (or its contract manufacturer's) manufacturing facility or
facilities, as applicable, would be exceeded by such quantities. If PMC so
notifies Aphton, the parties will negotiate in good faith the possible expansion
of the manufacturing capacity and the costs thereof. A Firm Order may not be
canceled and, following performance by PMC of its obligations hereunder with
respect to such order, Aphton shall be obligated to pay the price for said order
as provided in Sections 4.01 and 4.02 hereof. PMC shall be deemed to have met
its obligations hereunder in the event that the actual grams of Bulk Material
delivered in accordance with Section 5.01 hereof are equal to at least
[Redacted]*% of the quantities specified in the Firm Order. Aphton agrees to pay
for the grams actually received, but only to the extent that such amounts do not
exceed [Redacted]*% of the quantities specified in the Firm Order.
Notwithstanding the foregoing, in the event that market conditions require an
increase or decrease in the quantities of Bulk Material specified in any Firm
Order, the parties will negotiate in good faith alternative arrangements to meet
the business objectives of the parties.
4. PRICE AND PAYMENT
4.01 The price for Bulk Material shall equal: (a) in the case of DT,
US$[Redacted]* per gram (Index-adjusted) and (b) in the case of TT,
US$[Redacted]* per gram (Index-adjusted); provided that Article 6 DT/TT shall be
supplied to Aphton at no cost. The parties hereby amend the reference in Section
6.1(b) of the Marketing License to a price of "US$[Redacted]* per gram" for DT
to read "US$[Redacted]* per gram" to accord with this Section 4.01.
4.02 During the term of this Agreement and for a period of three (3)
years thereafter, upon reasonable request and notice of Aphton, PMC shall, at
the sole expense of Aphton, permit a reputable independent public accountant not
providing significant services to either Aphton, PMC or any of their respective
Affiliates, to have access during ordinary business hours to PMC's financial
records necessary to determine the correctness of the amount of any Bulk
Material allocated to Aphton pursuant to Section 2.02. Such accountant shall not
disclose any information other than a statement concerning the correctness of
such amount. Such examination may occur in any year in which there is a supply
shortfall. The right to request a determination under this Section 4.02 with
respect to any year shall terminate two (2) years after the end of such year. In
addition, in the event that either party hereto believes that cost factors or
market conditions adversely affect to a significant degree the cost structure of
------------------------
* The redacted portions of this document have been omitted pursuant to a
request for confidential treatment and such redacted portions have been
filed separately with the Securities and Exchange Commission.
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the transactions contemplated by this Agreement, the parties agree to discuss in
good faith appropriate adjustments to the price of Bulk Material hereunder to
respond to such cost factors or market conditions.
4.03 Bulk Material (other than Art. 6 DT/TT) supplied hereunder shall
be invoiced when delivered to Aphton in accordance with Section 5.01. Aphton
shall pay to PMC the price of each shipment of Bulk Material (other than Art. 6
DT/TT) delivered to Aphton as provided in Section 5.01 within thirty (30)
business days after the invoice date with respect to such delivery. Payment
shall be remitted in immediately available funds in United States dollars.
5. DELIVERY AND RISK OF LOSS
5.01 PMC shall deliver or arrange for the delivery of Bulk Material to
Aphton, DDP at a point or points of destination selected by Aphton.
5.02 Title to Bulk Material sold hereunder shall pass to Aphton upon
delivery to Aphton in accordance with Section 5.01, whereupon Aphton shall
assume all risk of loss or damage.
6. WARRANTY
6.01 EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 6.01, PMC MAKES NO
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. PMC
warrants that Bulk Material, when delivered to Aphton in accordance with Section
5.01 hereof shall meet the Specifications. Copies of the relevant establishment
and product licenses (with all confidential, proprietary material deleted
therefrom) shall be provided to Aphton upon its request.
6.02 If Aphton claims that the Bulk Material in any given shipment did
not at the time of delivery to Aphton in accordance with Section 5.01 meet the
Specifications, PMC shall conduct an assay of its retained samples from such
shipment. If Aphton's claim is correct, PMC, at its option, shall either replace
such shipment or reimburse or give credit for such payment to Aphton, in each
case together with any out-of-pocket expenses incurred by Aphton.
6.03 PMC shall retain batch data records and quality control
certificates for each batch of Bulk Material of which any portion is shipped to
Aphton and, if requested by Aphton, will provide such information to Aphton.
Such records shall be retained for the period required by any applicable Legal
Requirements.
7. GMP COMPLIANCE: INSPECTION OF FACILITIES; ADVERSE EXPERIENCE
REPORTING; RECORDS
7.01 The parties undertake to comply with all regulations of any
Public Authority having jurisdiction over the manufacturing, storage, handling
or sale of the Bulk Material in effect related to obtaining and maintaining
legal approval for the marketing and sale of the Bulk Material.
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7.02 Upon reasonable request by either party (the "Inspecting Party"),
the other party (the "Other Party") shall permit (or cause its contract
manufacturer to permit) duly authorized employees of the Inspecting Party and,
with the consent of the Other Party (not to be unreasonably withheld), other
representatives of the Inspecting Party, to inspect the Other Party's (or its
contract manufacturer's) facilities, procedures and capabilities to insure
continued compliance with this Agreement and applicable Legal Requirements,
provided that the Other Party may, in its sole discretion, refuse to grant
access to any areas of its facilities or manufacturing records if such access
could jeopardize the confidentiality of any of the Other Party's proprietary
technology.
7.03 During the term of this Agreement, each party shall notify the
other immediately of any information (howsoever obtained and from whatever
source) concerning any unexpected side effect, injury, toxicity or sensitivity
reaction, or any unexpected incidence, and the severity thereof, associated with
the clinical uses, studies, investigations, testing and marketing of the Bulk
Material. For purposes of this Section 7.03, "unexpected" shall mean (x) for a
non-marketed product, an experience that is not identified in nature, severity
or frequency in the current clinical investigator's confidential information
brochure, and (y) for a marketed product, an experience which is not listed in
the current labeling for such product, and includes an event that may be
symptomatically and pathophysiologically related to an event listed in the
labeling but differs from the event because of increased frequency or greater
severity or specificity. Each party shall further notify the other immediately
of any information received regarding any threatened or pending action by any
Public Authority which may affect the safety and efficacy claims of the Bulk
Material. Upon receipt of any such information, the parties shall consult with
each other in an effort to arrive at a mutually acceptable procedure for taking
appropriate action; provided, however, that nothing contained herein shall be
construed as restricting either party's right to make a timely report of such
matter to any Public Authority or take other action that it deems to be
appropriate or required by applicable law or regulation.
7.04 If reasonably requested by Aphton, all technical records relating
to the manufacturing, supply or provision of Bulk Material by or on behalf of
PMC shall be retained for a period of at least eleven (11) years from the date
of delivery of Bulk Material.
7.05 PMC agrees to provide such reasonable assistance and access to
regulatory filings on its DT or TT as may be reasonably necessary to permit
Aphton to obtain regulatory approval in any Regulatory Jurisdiction for any
Aphton product which incorporates Bulk Material as a component, subject to the
limitations set forth in Section 2.01 hereof.
8. SUPERIORITY
8.01 No provision on the Aphton purchase order form or on PMC's
general conditions of sale which may purport to impose different conditions upon
Aphton or PMC shall modify the terms of this Agreement.
9. INDEMNIFICATION
9.01 PMC hereby agrees to indemnify, defend and hold harmless Aphton,
its Affiliates, officers, directors, employees and agents from and against any
liabilities, claims, damages, costs, expense (including reasonable attorneys'
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fees), judgments (collectively, "Damages") arising out of, based upon or
resulting from (i) the manufacturing of the Bulk Material, (ii) the failure of
any Bulk Material to meet the Specifications therefor at the time of delivery to
Aphton in accordance with Section 5.01 hereof, or (iii) the breach by PMC of any
of its obligations or warranties hereunder, except to the extent any such
Damages arise out of, are based upon or result from the negligence or willful
misconduct of Aphton or a breach by Aphton of any of its obligations or
warranties hereunder or under the Aphton Supply Agreement.
9.02 Aphton hereby agrees to indemnify, defend and hold harmless PMC,
its Affiliates, officers, directors, employees and agents from and against any
Damages arising out of, based upon or resulting from (i) the negligence or
willful misconduct of Aphton or a breach by Aphton of any of its obligations or
warranties hereunder or under the Aphton Supply Agreement, (ii) the possession,
processing, shipment, storage or disposal of any Bulk Material supplied
hereunder, or (iii) the possession, manufacture, sale, use, distribution,
processing, shipment, storage or disposal of any product by Aphton, whether or
not any Bulk Material is incorporated therein. Notwithstanding the foregoing,
the indemnities set forth in Article 11 of the Marketing License shall govern
the parties' respective indemnification obligations in respect of the Product
(as defined therein). Aphton agrees to obtain and to maintain product liability,
clinical trial liability and environmental liability insurance (with PMC named
as an additional insured), with an insurer rated "A" or better by A.M. Best, in
the amount agreed upon by the Steering Committee pursuant to Article 11(c) of
the Marketing License. Such insurance may not be cancelled or terminated except
upon thirty (30) days' prior written notice to PMC. Such insurance, as it
applies to all Aphton products other than the Product (as defined in the
Marketing License), shall be obtained and maintained at Aphton's sole cost and
expense. From time to time, at the request of PMC, Aphton will cause
certificates of such insurance to be supplied to PMC evidencing compliance with
the obligations set forth herein. PMC shall not assert against Aphton, and PMC
hereby waives, any and all claims against Aphton for Damages imposed upon or
incurred by PMC arising out of, based upon or resulting from any claim covered
by such insurance, to the extent of such coverage and to the extent Aphton shall
have acknowledged in writing its obligation to indemnify PMC pursuant to this
Section 9.02 in respect of such claim.
9.03 (a) Any party entitled to indemnification under Section 9.01 or
Section 9.02 (an "Indemnified Party") shall promptly notify the party
potentially responsible for such indemnification (the "Indemnifying Party") upon
becoming aware of any claim or claims asserted or threatened against the
Indemnified Party which could give rise to a right of indemnification under this
Agreement, provided, however, that the failure to give such notice shall not
relieve the Indemnifying Party of its indemnity obligation hereunder except to
the extent that such failure substantially prejudices its rights hereunder.
(b) The Indemnifying Party shall have the right to defend, at its sole
cost and expense, such claim by all appropriate proceedings, which proceedings
shall be prosecuted diligently by the Indemnifying Party to a final conclusion
or settled at the discretion of the Indemnifying Party, provided, however, that
the Indemnifying Party may not enter into any compromise or settlement unless
(i) the Indemnified Party consents thereto, which consent shall not be
unreasonably withheld, and (ii) such compromise or settlement includes as an
unconditional term thereof, the giving by each claimant or plaintiff to the
Indemnified Party of a release from all liability in respect of such claim.
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(c) The Indemnified Party may participate in, but not control, any
defense or settlement of any claim controlled by the Indemnifying Party pursuant
to this Section 9.03 and shall bear its own costs and expenses with respect to
such participation, provided, however, that the Indemnifying Party shall bear
such costs and expenses if counsel for the Indemnifying Party shall have
reasonably determined that such counsel may not properly represent both the
Indemnifying Party and the Indemnified Party.
(d) If the Indemnifying Party fails to notify the Indemnified Party
within twenty (20) days after receipt of notice of a claim in accordance with
Section 9.03(a) that it elects to defend the Indemnified Party pursuant to this
Section 9.03, or if the Indemnifying Party elects to defend the Indemnified
Party but fails to prosecute or settle the claim diligently and promptly, then
the Indemnified Party shall have the right to defend, at the sole cost and
expense of the Indemnifying Party, the claim by all appropriate proceedings,
which proceedings shall be promptly and vigorously prosecuted by the Indemnified
Party to a final conclusion or settled, provided, however, that in no event
shall the Indemnifying Party be required to indemnify the Indemnified Party for
any amount paid or payable by the Indemnified Party in the settlement of any
such claim agreed to without the consent of the Indemnifying Party (not to be
unreasonably withheld).
10. TERM AND TERMINATION
10.01 This Agreement shall take effect as of the date hereof and shall
continue in effect unless terminated by a party in accordance with Section 10.02
hereof.
10.02 This Agreement may be terminated by either party if (i) the
other party fails to observe, perform or otherwise breaches any of its material
covenants agreements or obligations under this Agreement in any material respect
and (ii) such failure continues for a period of sixty (60) days after receipt by
the other party of notice thereof from the electing party specifying such
failure. Following such period, the electing party has ninety (90) days to give
notice to the other party of its election to terminate this Agreement.
10.03 Upon any termination of this Agreement, each party shall have no
further liability or obligation to the other, except to pay any amount accruing
to the other party under the provisions of this Agreement while it was in effect
and damages for any breach.
10.04 In addition, anything herein to the contrary notwithstanding,
the following provisions of this Agreement shall survive termination of this
Agreement for the longest period permitted by applicable law and/or required by
this Agreement with respect to all Bulk Material delivered prior to termination:
Sections 4.02, 7.02, 7.04, 10.03, 10.04, 12.01, 12.02 and 12.08 and Articles 6,
9 and 11.
11. CONFIDENTIALITY
11.01 Except as expressly set forth in this Article 11, each party
shall, and shall cause its Affiliates and its and their officers, directors,
employees, agents and subcontractors (collectively, "Representatives") to, keep
confidential any and all technical, commercial, scientific and other proprietary
data, processes, documents or other information (whether in oral or written
form) or physical object (including, without limitation, intellectual property,
marketing data, agreements between any party and a third party, license
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applications, and business plans and projections of any party) acquired from the
other party, its Affiliates or any of their respective Representatives in
respect of the transactions contemplated by this Agreement and which relates (in
the case of a party) to the other party or any of its Affiliates or their
respective businesses or products ("Confidential Information"), and each party
shall not disclose directly or indirectly, and shall cause its respective
Affiliates and Representatives not to disclose directly or indirectly, any
Confidential Information to anyone outside such Person, such Affiliates and
their respective Representatives, except that the foregoing restriction shall
not apply to any information disclosed hereunder to any party if such Person
(the "Receiving Person") can demonstrate that such Confidential Information:
(a) is or hereafter becomes generally available to the trade or public
other than by reason of any breach hereof;
(b) was already known to the Receiving Person, or such Affiliate or
Representative as shown by written records;
(c) is disclosed to the Receiving Person or such Affiliate or
Representative by a third party who has the right to disclose such
information;
(d) is developed by or on behalf of the Receiving Person or any of its
Affiliates independently, without reliance on Confidential Information
received hereunder; or
(e) based on such Person's good faith judgment with the advice of
counsel, is otherwise required to be disclosed in compliance with
applicable Legal Requirements by a Public Authority and such information
shall remain Confidential Information for all other purposes unless
subparagraphs (a) through (d) above otherwise apply.
11.02 Each party agrees that it shall not (and shall not permit any of
its Affiliates to) at any time use any Confidential Information in the conduct
of its businesses without the prior written consent of the other party. The
obligations set forth in this Article 11 shall extend to copies, if any, of
Confidential Information made by any of the Persons referred to in Section 11.01
and to documents prepared by such Persons which embody or contain Confidential
Information.
11.03 Each party shall deal with Confidential Information so as to
protect it from disclosure with a degree of care not less than that used by it
in dealing with its own information intended to remain exclusively within its
knowledge and shall take reasonable steps to minimize the risk of disclosure of
Confidential Information.
11.04 The obligations set forth in this Article 11 shall survive the
expiration, termination or assignment of this Agreement for a period of fifteen
(15) years thereafter.
11.05 Within thirty (30) days after the termination of this Agreement,
the Receiving Person shall (and shall cause its Affiliates and Representatives
to), at the option of the Disclosing Person, return to the Disclosing Person or
destroy all Confidential Information in its or their possession; provided,
however, that the Receiving Person may, upon notice to the Disclosing Person,
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retain in its legal files or in the office of outside legal counsel one copy of
any document solely for use in any pending legal proceeding to which such
document relates.
12. MISCELLANEOUS PROVISIONS
12.01 Any notices to be given hereunder shall be in writing and shall
be delivered by one of the following means: personal delivery, certified or
registered airmail, facsimile with confirmed receipt or confirmed delivery by an
overnight commercial courier service:
(a) if to Aphton, to:
Aphton Corporation
00 XX 0xx Xx.
Xxxxx, Xxxxxxx 00000
XXX
Attention: Chairman, President and Chief Executive Officer
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to:
Xxxxxxxxx X. Xxxxxx, Esq.
White & Case
0000 Xxxxxx xx xxx Xxxxxxxx
Xxx Xxxx, Xxx Xxxx 00000-0000
XXX
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
(b) if to PMC, to:
Connaught Laboratories Limited
0000 Xxxxxxx Xxxxxx Xxxx
Xxxxx Xxxx, Xxxxxxx X0X 0X0
Xxxxxx
Attention: Vice President and General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with copies to:
Pasteur Merieux Serums & Vaccins S.A.
00, xxxxxx Xxxxxxx - X.X. 0000
00000 Xxxx Cedex 07
France
Attention: Senior Vice President, Secretary and General Counsel
Telephone: (33)(4) 72.73.77.84
Facsimile: (33)(4) 72.73.70.61
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L. Xxxxx X'Xxxx, Xx., Esq.
Akin, Gump, Strauss, Xxxxx & Xxxx LLP
000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
12.02 This Agreement shall be governed by, and construed in accordance
with, the internal laws of New York, without regard to principles of conflict of
laws (other than Section 5-1401 of the General Obligations Law).
12.03 This Agreement shall be binding upon and shall inure to the
benefit of the parties and their respective successors and permitted assigns.
Notwithstanding the foregoing, neither party shall have the right to assign its
rights or obligations hereunder (whether by operation of law or otherwise)
without the prior written consent of the other party.
12.04 The parties shall execute and deliver such other documents and
take such other action as may be reasonably necessary to implement and carry out
the intent of this Agreement.
12.05 If any provision of this Agreement is ultimately held to be
invalid, illegal or unenforceable, the validity, legality and enforceability of
the remaining provisions hereof shall not in any way be affected or impaired
thereby, unless the absence of the invalidated provision materially and
adversely affects the substantive rights of the parties hereto. To the extent
permitted by applicable law, each party hereby waives any provision of law which
renders any provision hereof invalid, illegal or unenforceable in any respect.
In the event that any provision hereof shall be held to be invalid, illegal or
unenforceable and the absence of such provision materially and adversely affects
the substantive rights of the parties hereunder, the parties hereto shall use
their best efforts to replace the invalidated provision with a legal, valid and
enforceable provision which, insofar as practicable, implements the intent of
the invalidated provision.
12.06 Except as otherwise provided herein, no term or condition of
this Agreement may be waived or qualified at any time except by a written
instrument executed by both parties hereto. No waiver of any provision of this
Agreement shall constitute a waiver of any other provision, nor shall such
waiver preclude subsequent reliance on such provision. Except as otherwise
expressly provided herein, no omission, delay or failure on the part of any
party in exercising any right or remedy, and no partial exercise thereof, will
constitute a waiver of any right remedy or preclude its further exercise or the
exercise of any other right or remedy.
12.07 Each of the parties shall pay their respective legal, accounting
and other professional advisory fees, costs and expenses incurred in connection
with the execution and delivery of this Agreement and all documents and
instruments executed pursuant to this Agreement and any other costs and expenses
incurred.
12.08 No party shall be liable to the other, or be in default under
the terms of this Agreement, for its failure to fulfill its obligations
hereunder to the extent such failure arises for any reason beyond its control
including, without limitation, strikes, lockouts, labor disputes, acts of God,
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acts of nature, acts of governments or their agencies, fire, flood, storm, power
shortages or power failure, war, sabotage, inability to obtain sufficient labor,
raw materials, fuel or utilities, or inability to obtain transportation (each,
an "Event of Force Majeure"), provided that the party relying on the provisions
of this Section 12.08 shall forthwith give to the other notice of its inability
to observe or perform the provisions of this Agreement and the reasons therefor,
and provided further that the suspension of the obligations of the party so
affected will continue only for so long as such Event of Force Majeure
continues.
12.09 This Agreement contains the entire understanding of the parties
with regard to the subject matter of this Agreement and supersedes all prior
agreements and understandings of the parties with respect to the subject matter
hereof. This Agreement may not be supplemented or amended, except by a writing
signed by both parties.
12.10 This Agreement may be executed in any number of counterparts,
each of which when delivered shall be deemed to be an original and all of which
together shall constitute one and the, same document.
12.11 The parties acknowledge that it is in their mutual interest to
ensure that the transactions contemplated hereunder are structured in the most
tax-efficient manner. In the event that a party believes that these transactions
can be restructured in order to achieve a more efficient tax outcome for one or
both parties, the parties agree to work together to implement such
restructuring, provided that such new structure respects the economic terms
(disregarding tax effects) of the relationship.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed as of the date hereof by their duly authorized officers or
representatives.
CONNAUGHT LABORATORIES LIMITED
By /s/ J. Xxxx Xxxxxxxx
---------------------------------------
Name: J. Xxxx Xxxxxxxx
Title: Senior Vice President,
and General Manager,
Oncology Business Unit
By /s/ Xx. Xxxxxx X. X. Xxxxx
---------------------------------------
Name: Xx. Xxxxxx X. X. Xxxxx
Title: Vice President, Industrial
Operations
APHTON CORPORATION
By /s/ Xxxxxx Xxxxx
---------------------------------------
Name: Xxxxxx Xxxxx
Title: Chairman, President & CEO
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