APHTON 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 offices in Miami, Florida,
USA ("Aphton").
W I T N E S S E T H :
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WHEREAS, Aphton owns or controls certain patents, patent applications
and proprietary information relating to its therapeutic cancer vaccine
("Gastrimmune(TM)"); and
WHEREAS, CLL 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, Section 3.2 of the Marketing License provides that Aphton and
PMC will enter into a supply agreement to provide for a supply of
Gastrimmune(TM) for PMC to co-promote, market, distribute and sell in accordance
with the Marketing License.
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 "Fully Absorbed Cost" shall mean all fixed and variable costs,
including overhead, of Product in accordance with Generally Accepted Accounting
Principles in effect in the United States consistently applied.
1.03 "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.
1.04 "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.
1.05 "PMC Supply Agreement" shall mean the PMC Supply Agreement of
even date herewith, between CLL and Aphton.
1.06 "Product" shall mean Aphton's Gastrimmune(TM) product as
currently being developed by Aphton, as it may be improved or modified at any
time during the term hereof.
1.07 "Public Authority" shall mean any supranational, national,
regional, state or local government, court, governmental agency, authority,
board, bureau, instrumentality or regulatory body.
1.08 "Specifications" shall mean the specifications for the Product as
described in Aphton's product license applications.
1.09 "Third Party" shall mean any Person which is not an Affiliate of
any party hereto.
2. SUPPLY OF PRODUCT
2.01 Subject to Section 2.02 hereof, Aphton agrees to manufacture (or
have manufactured) and supply, and PMC agrees to purchase, such amounts of
Product for sale by PMC pursuant to the Marketing License, as PMC may from time
to time order in accordance with the terms of this Agreement.
2.02 In the event that the available quantities of Product are limited
due to an Event of Force Majeure (as defined in Section 12.08 hereof), Aphton
shall notify PMC of such shortage as soon as possible and shall allocate to PMC
a pro rata share of the amount of Product available to Aphton from Aphton's
manufacturing facility (or contract manufacturer, as applicable), based upon the
number of doses of Product reflected in the applicable Forecast in comparison to
the total number of doses of Product reflected in the Operating Plan (as defined
in the Marketing License), subject to verification by PMC in accordance with
Section 4.02 hereof.
3. FORECASTS AND ORDERS FOR PRODUCT
3.01 Commencing sixty (60) days prior to the date first established by
the Steering Committee as the likely date of Commercial Launch (as defined in
the Marketing License) of the Product in any Regulatory Jurisdiction (the
"Commercial Launch Date"), Aphton will supply, and PMC will purchase from
Aphton, quantities of Product determined in accordance with the procedures set
forth in this Article 3.
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3.02 Beginning on January 1 of the year in which the Commercial Launch
Date is expected to occur and every three months thereafter for so long as this
Agreement shall remain in effect, PMC shall provide Aphton with a rolling
9-month forecast of its requirements for Product (each, a "Forecast"), which
Forecast will be consistent with the relevant Marketing Plan for each Indication
contemplated by the Marketing License. The initial Forecast shall specify the
number of doses per Regulatory Jurisdiction in which licensure is expected to be
obtained in order to permit Commercial Launch and the expected delivery dates,
based upon the expected Commercial Launch Date. As to each Regulatory
Jurisdiction in which Commercial Launch has occurred, the quantities specified
in the Forecast (i) in respect of the first three month period following the
actual date of Commercial Launch covered thereby, shall constitute an
irrevocable, firm order (a "Firm Order") as to the quantities of Product,
delivery dates and delivery locations specified therein, (ii) in respect of the
second three month period following the actual date of Commercial Launch covered
thereby, shall constitute a Firm Order as to the quantities of Product specified
therein only, and (iii) in respect of the third three month period following the
actual date of Commercial Launch covered thereby, shall constitute a non-binding
estimate; provided that such quantities do not exceed Aphton's annual
manufacturing capacity for Product as of the date of the Forecast. The Forecast
will specify quantities per Regulatory Jurisdiction only in respect of those
Regulatory Jurisdictions in which Commercial Launch has occurred as of the date
of the Forecast. No quantities in excess of Aphton's annual manufacturing
capacity for Product as of the date of the Forecast will constitute a Firm Order
if Aphton has notified PMC (within ninety (90) days of the receipt of the
applicable Forecast) that the annual Product manufacturing capacity of its (or
its contract manufacturer's) manufacturing facility would be exceeded by such
quantities. If Aphton so notifies PMC, the parties, in accordance with the
provisions of the Marketing License, will consider the possible expansion of the
manufacturing capacity (either through new contract manufacturing arrangements
or by delegating all or a portion of manufacturing responsibility to PMC) and
the costs thereof. In the event that Aphton cannot for any reason supply Product
to PMC in accordance with this Agreement, PMC shall have the right to
manufacture the Product pursuant to the Marketing License. A Firm Order may not
be canceled and, following performance by Aphton of its obligations hereunder
with respect to such order, PMC shall be obligated to pay the price for said
order as provided in Sections 4.01 and 4.02 hereof. Notwithstanding the
foregoing, in the event that market conditions require an increase or decrease
in the quantities of Product 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 Product shall equal [Redacted]*.
4.02 The price of Product may be changed by Aphton from time to time
(but no more than a reasonable number of times per year) in accordance with the
provisions of the Marketing License to reflect changes in Aphton's Fully
Absorbed Cost for Product. During the term of this Agreement and for a period of
three (3) years thereafter, upon reasonable request and notice of PMC, Aphton
shall, at the sole expense of PMC, 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
Aphton's financial records necessary to determine (i) the correctness of the
calculation of Aphton's Fully Absorbed Cost for manufacturing Product, and/or
(ii) the correctness of the amount of any Product allocated to PMC pursuant to
------------------------
* 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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Section 2.02. Such accountant shall not disclose any information other than a
statement concerning the correctness of such calculation. Such examination shall
not take place more than once every two (2) years, in the case of any cost
determination, and may occur in any year in which there is a supply shortfall,
in the case of any allocation pursuant to Section 2.02. 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 transactions contemplated by this
Agreement, the parties agree to discuss in good faith appropriate adjustments to
the price of Product hereunder to respond to such cost factors or market
conditions.
4.03 Product supplied hereunder shall be invoiced when delivered to
PMC in accordance with Section 5.01. PMC shall pay to Aphton the price of each
shipment of Product delivered to PMC 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 Aphton shall deliver or arrange for the delivery of Product to
PMC, DDP to a point or points of destination selected by PMC.
5.02 Title to Product sold hereunder shall pass to PMC upon delivery
to PMC in accordance with Section 5.01, whereupon PMC shall assume all risk of
loss or damage.
6. WARRANTY; RECALLS
6.01 EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 6.01, APHTON MAKES
NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Aphton warrants that (a) Product, when delivered to PMC in accordance with
Section 5.01 hereof, shall meet the Specifications, and (b) it shall manufacture
and store Product in strict compliance with any Legal Requirements. Copies of
the relevant establishment and product licenses (with all confidential,
proprietary material deleted therefrom) shall be provided to PMC upon its
request.
6.02 If PMC claims that the Product in any given shipment did not at
the time of delivery to PMC in accordance with Section 5.01 meet the
Specifications, Aphton shall conduct an assay of its retained samples from such
shipment. If PMC's claim is correct, Aphton, at its option, shall either replace
such shipment or reimburse or give credit for such payment to PMC, in each case
together with any out-of-pocket expenses incurred by PMC.
6.03 Aphton shall retain batch data records and quality control
certificates for each batch of the Product and, if requested by PMC, will
provide such information to PMC. Such records shall be retained for the longest
period required by any Regulatory Jurisdiction in the Territory.
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6.04 Aphton and PMC shall observe at all times all Legal Requirements
in order to maintain an effective system for the recall from the market of the
Product. Notwithstanding anything herein to the contrary, if Aphton or PMC deems
it necessary to effect a recall of the Product, it shall give the other party
reasonable notice under the circumstances of such intended recall and an
appropriate time to discuss and agree on such intended recall. In the event that
agreement cannot be reached on effecting the recall within five (5) business
days, the party who desires, in its reasonable judgment, to effect the recall
may do so, provided that all costs of the recall shall be paid by such party
unless the other party acted unreasonably in desiring not to effect the recall,
in which event such costs shall be shared equally by the parties. The other
party shall take no action contrary to the recall and shall cooperate fully with
the party effecting the recall.
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 Product in effect related to obtaining and maintaining legal
approval for the marketing and sale of the Product.
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
Product. 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 Product.
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.
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7.04 If reasonably requested by PMC, all technical records relating to
the manufacturing, supply or provision of Product by or on behalf of Aphton
shall be retained for a period of at least eleven (11) years from the date of
delivery of Product.
7.05 Aphton agrees to provide such reasonable assistance and access to
regulatory filings on the Product as may be reasonably necessary to permit PMC
to obtain regulatory approval in any Regulatory Jurisdiction for the Product
where Aphton does not obtain such regulatory approval under the Marketing
License.
8. SUPERIORITY
8.01 No provision on the PMC purchase order form or on Aphton'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 Aphton hereby agrees to indemnify, defend and hold harmless PMC,
its Affiliates, officers, directors, employees and agents from and against any
liabilities, claims, damages, costs, expense (including reasonable attorneys'
fees), judgments (collectively, "Damages") arising out of, based upon or
resulting from (i) the manufacturing of the Product, (ii) the failure of the
Product to meet the Specifications therefor at the time of delivery to PMC in
accordance with Section 5.01 hereof, or (iii) the breach by Aphton 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
PMC or a breach by PMC of any of its obligations or warranties hereunder or
under the PMC Supply Agreement.
9.02 PMC hereby agrees to indemnify, defend and hold harmless Aphton,
its Affiliates, officers, directors, employees and agents from and against any
Damages arising out of, based upon or resulting from the negligence or willful
misconduct of PMC or a breach by PMC of any of its obligations or warranties
hereunder or under the PMC Supply Agreement.
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 The term of this Agreement shall commence on the date hereof
and, unless terminated by a party in accordance with Section 10.02 hereof, shall
terminate on February 14, 2017, unless extended upon the written agreement of
the parties hereto for an additional five-year term.
10.02 This Agreement may be terminated:
(a) 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 thirty (30) 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;
or
(b) by Aphton in the event of a termination of the Marketing License
due to a material breach by PMC.
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 Product 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.
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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
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.
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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,
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
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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
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
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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,
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.
APHTON CORPORATION
By /s/ Xxxxxx Xxxxx
------------------------------------------
Name: Xxxxxx Xxxxx
Title: Chairman, President & CEO
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. X. X. Xxxxx
-----------------------------------------
Name: Xx. X. X. Xxxxx
Title: Vice President, Industrial
Operations
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