6
DC_DOCS\84421.8
RESEARCH, COLLABORATION
AND
DISTRIBUTION AGREEMENT
This Agreement is made and entered into the 22nd day of
December, 1997, by and between PerImmune, Inc., a Delaware
corporation ("PERIMMUNE"), maintaining an office at 0000 Xxxxxxx
Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000-0000 and Mentor Corporation, a
Minnesota corporation ("MENTOR") maintaining an office at 0000
Xxxxxxxxx Xxxxxx, Xxxxx Xxxxxxx, XX 00000.
RECITALS
WHEREAS, PERIMMUNE has developed and refined a method
of treating urological diseases and cancer with a keyhole limpet
hemocyanin composition and is the owner of all rights to
proprietary technical information and the U.S. Patent (as defined
herein) related thereto;
WHEREAS, PERIMMUNE has advised MENTOR that PERIMMUNE
believes that it can, within a period of three (3) years at a
cost of approximately Three Million Dollars ($3,000,000): (a)
implement and complete a Phase III clinical testing program for
the use of the Product (as defined herein) to treat refractory
bladder cancer, as clinically defined in the PERIMMUNE Phase I/II
protocol and clinical results previously provided to MENTOR
("Refractory Bladder Cancer"), and (b) submit an application for
the use of such Product to the United States Food and Drug
Administration (the "FDA") for the treatment of Refractory
Bladder Cancer;
WHEREAS, PERIMMUNE and MENTOR desire to enter into an
arrangement pursuant to which MENTOR will fund the costs of
implementing and carrying out the program described in the
preceding recital, and pay certain fees to PERIMMUNE as agreed
milestones in such program are attained, and PERIMMUNE will grant
to MENTOR on the terms and conditions set forth in this agreement
the exclusive worldwide right to market, sell and distribute the
Product for the Indicated Uses (as defined herein);
WHEREAS, PERIMMUNE and MENTOR agree that, despite the
diligent efforts of PERIMMUNE and MENTOR, there can be no
assurance that the objectives of the Project Development
Activities or the Project Objective (each as defined herein) will
be attained or that the Project Development Activities will
result in commercial use of the Product for any one or more
Indicated Uses.
NOW, THEREFORE, for and in consideration of the
foregoing and the mutual covenants and agreements contained
herein, and certain other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the
parties agree as follows:
ARTICLE
DEFINITIONS
"Affiliate" means, with respect to any Person, any
other Person directly or indirectly controlling or controlled by,
or under common control with, such specified Person.
"Approvals" means, with respect to any governmental
authority or agency, any or all approvals, clearances,
registrations, licenses, authorizations, visas or permits
required by such governmental authority or agency in order to
import, export, offer for sale, sell, market, manufacture, have
made or use the Product.
"Competitive Product" means any product constituted
from KLH (as defined herein) that is used in the Indicated Uses.
"Effective Date" means the date of this Agreement as
set forth above.
"Indicated Uses" means the use of the Product in all
uro-genital applications, including but not limited to use as an
injectable bio-pharmaceutical to treat cancer of the bladder and
prostate gland and interstitial cystitis.
"Improvements" means all modifications, variations and
revisions and new models or versions of the Product developed by
the parties hereto which relates or has consequence with respect
to the Product in any of the following ways: (1) improves the
Product's performance; (2) reduces the cost of materials or
components for the Product; (3) reduces production, manufacturing
or associated costs of the Product; (4) increases the life,
durability or continuous performance characteristics of the
Product; (5) expands the applications to which the Product may be
put; (6) increases or enhances the marketability or commercial
aspect of the Product; or (7) would, if implemented, replace or
displace the Product in one or more material commercial markets
for the Product. Improvements may be patentable or unpatentable,
and if patentable, need not be patented.
"Net Sales" means the gross invoiced price for the sale
of Product to purchasers by MENTOR, its agents or Affiliates less
(a) any credits and allowances granted by MENTOR to purchasers
with respect to the Product, including, without limitation,
credits and allowances on account of price adjustments, returns,
discounts and chargebacks, (b) any sales, excise, value-added,
turnover or similar taxes, and (c) transportation, insurance and
handling expenses if separately invoiced and directly chargeable
to such sales.
"Person" means any individual, corporation,
partnership, association, trust, estate or other entity or
organization, including any governmental entity or authority.
"Product" means the keyhole limpet hemocyanin
composition ("KLH"), as more particularly described in the
PERIMMUNE Phase I/II protocol and the U.S. Patent (as defined
herein), and any Improvements thereto.
"Product Patents" means any and all United States
patents and patent applications, all divisionals, continuations,
continuations-in-part, re-issues, extensions or foreign
counterparts thereof, now or hereafter owned or controlled
("controlled" being used in the sense of having the right to
grant licenses thereunder) by PERIMMUNE, covering the
manufacture, use, sale, offer for sale and/or importation of the
Product, including but not limited to, the U.S. Patent No.
5,407,912 attached hereto as Exhibit B.
"Project Budget" means the budget attached as Exhibit A
to this Agreement, setting forth the estimated costs of carrying
out the Project Development Activities.
"Project Development Activities" means the program
implemented pursuant to the provisions of this Agreement in order
to accomplish the following objectives in the following order of
priority: (a) the implementation and completion of Phase III
clinical testing of the Product for use in the treatment of
Refractory Bladder Cancer; (b) the preparation and filing of an
application with the FDA on or before June 30, 2000, for the
approval by the FDA of the use of the Product for the treatment
of Refractory Bladder Cancer; (c) obtaining FDA approval for the
use of the Product for the treatment of Refractory Bladder
Cancer; and (d) identifying and establishing contractual
relationships with sources of supply for raw materials required
to manufacture the Product.
"Project Objective" means the issuance of an approval
by the FDA for the use of the Product in the treatment of
Refractory Bladder Cancer.
"Product Information" means, individually and
collectively, all manufacturing, analytical and marketing
information and technical know-how, trade secrets and inventions
owned, controlled, conceived and/or reduced to practice and/or
acquired (i) by PERIMMUNE before the date this Agreement, or (ii)
by PERIMMUNE or MENTOR or jointly by the parties during the
Research and Development Period, and directed to the Product,
(whether or not relating to any Indicated Use), including, but
not limited to, specifications for ingredients and formulations,
information relating to regulatory and clinical work, testing or
studies, manufacturing methods and procedures.
"Project Plan" means the research and development plan
attached hereto as Exhibit A, including the budget, time-lines
and milestones reflected in such Exhibit for carrying out the
Project Development Activities.
"Quality Specifications" means the quality
specifications for the Product agreed upon by the Joint
Committee, as such quality specifications shall be modified from
time to time by mutual agreement of the parties hereto.
"Research and Development Period" means the period
commencing on the Effective Date and continuing until the first
to occur of either of the following events: (a) the attainment of
the Project Objective or (b) a joint determination by the parties
hereto that the Project should be discontinued.
"Target Period" means a period of thirty-six (36)
months, measured from the Effective Date.
"Vial" means a vial containing the quantity of the
product that is the standard dosage for a single treatment, which
the parties hereto believe is likely to be an quantity between
two (2) and ten (10) mg.
"U.S. Patent" means United States Patent No. 5,407,912
attached hereto as Exhibit B.
ARTICLE
RESEARCH AND DEVELOPMENT
Joint Committee. Promptly upon execution of the
Agreement, PERIMMUNE and MENTOR shall form a Joint Research and
Development Committee (the "Joint Committee") comprising six (6)
members for the purposes of implementing and revising the Project
Plan and coordinating the Project Development Activities to be
conducted by the Project Teams. Three members of the Joint
Committee (and their successors or replacements, if any) shall be
appointed by PERIMMUNE and three members (and their successors or
replacements, if any) shall be approved by MENTOR. All actions
of the Joint Committee shall be by a majority vote of all
members.
Project Teams. In order to carry out its respective
obligations relating to the Project Development Activities, each
of PERIMMUNE and MENTOR shall assign a defined team of employees
to perform the Project Development Activities (each such team, a
"Project Team" and, together, the "Project Teams"). The initial
PERIMMUNE Project Team shall comprise the individuals listed on
Exhibit C attached hereto and the research technicians under each
of their direction and control. The initial MENTOR Project Team
shall comprise the individuals listed on Exhibit D attached
hereto and the research technicians under each of their direction
and control. PERIMMUNE and MENTOR each agree to notify the other
party of any change in the personnel comprising such party's
Project Team, which changes shall remain in the sole discretion
of such party.
Project Development. PERIMMUNE will exercise due
diligence in carrying out the Project Development Activities at
the time and in the manner contemplated by the Project Plan, and
endeavoring to achieve the Project Objective. Each party shall
furnish to the other materials, data, software, specification,
formulas or other information as may, in the sole judgment of the
Joint Committee, be reasonably necessary for the recipient of
such information to perform its Project Development Activities or
other duties hereunder. Towards this end, the PERIMMUNE Project
Team shall periodically (which, in any event, shall be at least
once every calendar quarter) during the Research and Development
Period, provide to the MENTOR Project Team a written progress
report in form and substance established by the Joint Committee
concerning the Project Development Activities being conducted by
the PERIMMUNE Project Team, which report shall include a summary
of the progress of the Project Development Activities in relation
to the then current Project Budget that has been approved by the
Joint Committee. Information relating to the Product provided to
a party hereunder shall be governed by Section 10.1. The parties
agree that, despite the diligent efforts of the parties, there
can be no assurance that the objectives of the Project
Development Activities or the Project Objective will be attained
or that the Project Development Activities will result in
commercial use of the Product for any one or more Indicated Uses.
Compliance with Regulations. All activities, studies
or other efforts in furtherance of the Project Development
Activities shall be carried out pursuant to the Project Plan in
strict compliance with any applicable United States Federal,
state or local laws, regulations or guidelines governing the
conduct of such activities, studies or efforts.
Project Development Costs. The costs and expense of the
Project Development Activities shall be borne and paid by the
parties as follows:
2.5.1. Costs Payable by MENTOR. MENTOR shall
pay (a) all reasonable costs associated with the
Project Development Activities as reflected in the
Project Budget, to the extent that such costs do not
exceed the sum of $3,000,000, plus (b) the costs of any
additional work requested by MENTOR that is not within
the scope of the Project Development Activities (e.g.,
preparing applications for Approvals of the Product for
additional Indicated Uses or for jurisdictions other
than the United States) and (c) the costs of carrying
out additional clinical testing or other work required
by the FDA after the submission of the application for
Approval for the use of the Product to treat Refractory
Bladder Cancer, to the extent that such additional
testing or other work was not reasonably within the
scope of or contemplated by the Project Development
Activities described in the Project Plan.
2.5.2. Costs Payable by PERIMMUNE. Subject to
the obligations of MENTOR set forth in Section 2.5.1,
above, PERIMMUNE shall be responsible for and shall pay
all costs of the Project Development Activities to the
extent such costs exceed $3,000,000, including the
costs that would customarily be incurred by a
manufacturer in the ordinary course of business for the
purpose of submitting an application for pre-marketing
approval to the FDA and prosecuting such application to
completion and the issuance of the Approval applied
for.
2.5.3. Time and Manner of Payment. All amounts
payable by MENTOR to PERIMMUNE pursuant to this Section
2.5 shall be payable in advance by wire transfer of
same day funds on a quarterly basis. MENTOR shall pay
the estimated costs of the Project Development
Activities for the period beginning on the Effective
Date of this Agreement and ending on March 31, 1998
concurrently with its execution of this Agreement.
Thereafter, MENTOR shall pay the estimated costs of the
Project Development Activities for the next calendar
quarter within ten (10) days after the start of such
calendar quarter unless MENTOR is entitled to delay or
suspend the next quarterly payment as provided by
Section 2.5.6 of this Agreement. Amounts not expended
during any quarter or year shall be carried forward to
succeeding periods, it being intended that (a) MENTOR
shall be obligated to expend $3,000,000 during the
Target Period or until the Project Objective is
attained, whichever occurs first, and (b) any amounts
up to $3,000,000 remaining unexpended after the
attainment of the Project Objective, shall be paid to
PERIMMUNE as an additional fee.
2.5.4. Limitation on Obligation. Except as
expressly provided by Section 2.5.1, above, MENTOR
shall not be obligated to pay more than $3,000,000 of
the costs of the Project Development Activities, and
PERIMMUNE shall pay all costs and expenses in excess of
such amount.
2.5.5. Use of Funds. PERIMMUNE shall use the
funds paid by MENTOR pursuant to Section 2.5.3, above,
only for the payment of the costs and expenses of the
Project Development Activities. No portion of any such
funds shall be used (a) for the payment of PERIMMUNE's
overhead or general and administrative expenses, except
to the extent that such expenses have been properly
allocated to the Project Development Activities at the
same rate at which such expenses are allocated to all
other projects and corporate activities of PERIMMUNE,
or (b) for the acquisition of capital equipment or
other tangible personal property having a useful life
in excess of three (3) years.
2.5.6 Right of MENTOR to Suspend Payment.
PERIMMUNE shall provide to MENTOR from time to time
such information as MENTOR may reasonably request for
the purpose of demonstrating that there are sufficient
funds remaining in the Project Budget and available to
PERIMMUNE to complete the Project Development
Activities. MENTOR shall be entitled to suspend
payment of costs associated with the Project
Development Activities if (a) PERIMMUNE fails to submit
the quarterly report called for by Section 2.3 of this
Agreement, or (b) any such report evidences that
(i) PERIMMUNE is not carrying out the Project
Development Activities in accordance with the terms and
within the period of time established by the Project
Plan, or (ii) in MENTOR's reasonable judgment, there
will be insufficient funds available in the Project
Budget to attain the Project Objective within the
Target Period. Should MENTOR become entitled to
suspend payments to PERIMMUNE hereunder, then MENTOR
shall not be required to resume payments until
PERIMMUNE has taken the corrective action necessary to
eliminate the cause of such suspension in payments.
ARTICLE
DEVELOPMENT FEES PAYABLE TO PERIMMUNE
Payment Schedule. In addition to funding the cost of
the Project Development Activities provided in Section 2.5,
MENTOR shall pay to PERIMMUNE as a research and development fee,
an aggregate amount equal to Three Million Dollars ($3,000,000),
payable upon the occurrence of the following events (each, a
"Milestone Event" and the payment in respect of each Milestone
Event, a "Milestone Payment"): (i) One Million Dollars
($1,000,000)
upon the enrollment of the first patient in Phase III
clinical trials under protocols accepted by the United States
Food and Drug Administration ("FDA") for use of the Product for
an Indicated Use, (ii) One Million Dollars ($1,000,000) upon the
enrollment of the last patient in such Phase III clinical trials,
and (iii) One Million Dollars ($1,000,000) upon obtaining FDA
approval to market and sell the Product for an Indicated Use.
Manner of Payment. PERIMMUNE shall provide to MENTOR
written notice of the satisfaction of each Milestone Event.
Promptly upon receipt of such written notice, and, in any event
within five (5) days, thereafter, MENTOR shall pay to PERIMMUNE,
by wire transfer of same day funds, the Milestone Payment in
respect of such Milestone Event.
ARTICLE
OWNERSHIP OF INVENTIONS AND PATENTS
Ownership of Information. All Product Information is,
or shall be, owned solely by PERIMMUNE. Other than as may be set
forth herein, MENTOR shall have no rights in or to any Project
Information.
License. PERIMMUNE hereby grants MENTOR a world-wide,
royalty-free, perpetual, non-exclusive license in the Product
Information, the Product Patents and the Approvals to make, use
and sell the Product for use in the Indicated Uses without any
further duty or obligation to PERIMMUNE. MENTOR covenants that
it shall not exercise such license except upon the occurrence of
one or more of the circumstances set forth in Section 7.4(i),
7.4(ii), 7.4(iii) or 7.4(iv).
Ownership of Product Patents and Improvements.
PERIMMUNE shall have sole and exclusive ownership of the Product
Patents and of any Improvements (whether patentable or
unpatentable) made or discovered by PERIMMUNE or MENTOR
separately or by the parties jointly. PERIMMUNE shall be
responsible for the preparation, filing and prosecution of
Product Patents as well as all costs and fees associated
therewith. PERIMMUNE shall apply for, seek prompt issuance of
and maintain during the terms of this Agreement the Product
Patents in all jurisdictions where patent protection is available
and where, in PERIMMUNE's judgment, such patent protection is
necessary or advisable given plans for marketing the Product for
one or more of the Indicated Uses. The preparation, prosecution
and maintenance of all Product Patents shall be the primary
responsibility of PERIMMUNE; provided however, that MENTOR shall
be afforded reasonable opportunities to advise PERIMMUNE and
shall cooperate with PERIMMUNE in such preparation, prosecution
and maintenance. PERIMMUNE shall promptly advise MENTOR of the
grant, lapse, revocation, surrender, or any threatened
invalidation or of its intention to abandon any such patent,
application or foreign counterpart.
Infringement of Product Patents. PERIMMUNE and MENTOR
shall each promptly notify the other of any infringement of any
Product Patent in any jurisdiction which may come to its
attention. PERIMMUNE shall promptly undertake reasonable efforts
to obtain a discontinuance of the aforesaid infringement or
unauthorized use. Any suit to obtain such discontinuance shall
be brought by PERIMMUNE in its name unless the law of the
relevant forum requires otherwise.
ARTICLE
REGULATORY AFFAIRS
Approvals. PERIMMUNE shall hold the biological license
application ("BLA") and all other Approvals for the Product.
Assistance in Gaining Approvals. PERIMMUNE shall
exercise due diligence in attempting to obtain and in maintaining
in full force and effect the Approval for the marketing and sale
of the Product in the United States for the treatment of
Refractory Bladder Cancer. At MENTOR's request, PERIMMUNE shall
exercise due diligence in attempting to obtain and in maintaining
in full force and effect the Approvals for the marketing and sale
of the Product (i) for Indicated Uses other than Refractory
Bladder Cancer in the United States and (ii) for Indicated Uses
in Canada, the member states of the European Community, and in
each other jurisdiction in which MENTOR desires to market and
sell the Product for the Indicated Uses, provided that, in each
case, MENTOR shall bear all costs, fees and other expenses
required to be paid to regulatory authorities for the purpose of
applying for, obtaining or preserving such Approvals, provided
further that, in each case, if any application or submission
required to gain such Approvals requires additional clinical
tests or data beyond the clinical tests and data that are
produced during the clinical tests required to gain Approval for
the marketing and sale of the Product in the United States,
MENTOR shall bear all costs of conducting additional clinical
tests and obtaining such additional clinical data, and provided
further that, in each case, MENTOR shall, at no charge to
PERIMMUNE, provide reasonable assistance to PERIMMUNE in making
such applications, submissions or filings as may be required or
advisable to obtain such Approvals. Notwithstanding anything
else herein to the contrary, PERIMMUNE shall not be required to
attempt to obtain any Approval for the marketing or sale of the
Product for Indicated Uses in any jurisdiction if, in the
reasonable judgment of PERIMMUNE, such efforts separably or in
the aggregate would affect PERIMMUNE's ability to attain the
Project Objective.
Notice of Reports to Government Authorities. Each
party shall promptly notify the other party of any information
coming to its attention concerning experience with any Product
for which records and reports are filed with any governmental
authority, but shall not be liable for any intentional failure to
do so.
ARTICLE
DISTRIBUTION
Appointment and Acceptance. PERIMMUNE hereby appoints
MENTOR as its exclusive worldwide distributor of the Product for
the Indicated Uses during the term of this Agreement and MENTOR
agrees to act in this capacity, all subject to the terms and
conditions of this Agreement. During the term of this Agreement,
(a) neither PERIMMUNE nor any of its Affiliates shall market or
distribute the Product for use in the Indicated Uses, (b)
PERIMMUNE shall not license any other Person to market or
distribute the Product for use in the Indicated Uses, (c)
PERIMMUNE shall not supply to any person other than MENTOR and
its Affiliates Product that indicates on its label or in any
product information sheet or other packaging accompanying the
Product that the Product is suitable for use in the Indicated
Uses, and (d) PERIMMUNE shall not knowingly sell the Product to
persons whom PERIMMUNE knows or has reason to know will use the
Product in the Indicated Uses or will distribute or re-sell the
Product for such uses.
Terms of Sale.
MENTOR shall purchase its requirements for the
Product during the term of this Agreement solely from PERIMMUNE
for a purchase price to be calculated as set forth herein and
PERIMMUNE shall use all reasonable best efforts to supply all
such requirements.
Within thirty (30) days from the date of invoice
for any Product sold to MENTOR, MENTOR shall pay to PERIMMUNE an
amount equal to Thirty Dollars ($30) per Vial of the Product
(such amount, the "Advance"). Additionally, within thirty (30)
days of the close of each calendar quarter in which MENTOR has
purchased Product from PERIMMUNE pursuant hereto, MENTOR shall
pay to PERIMMUNE an amount equal to (i) thirty percent (30%) of
MENTOR's aggregate Net Sales (as defined herein) from the Product
during the calendar quarter (the "Percentage Sales Amount") less
(ii) the aggregate amount equal to (A) the number of Vials sold
during such calendar quarter for which MENTOR has paid to
PERIMMUNE an Advance, multiplied by, (B) the Advance amount (such
aggregate amount, the "Quarterly Advance Amount"). In the event
that the Quarterly Advance Amount in respect of any calendar
quarter shall exceed the Percentage Sales Amount for such
calendar quarter, then the amount payable to PERIMMUNE pursuant
to the preceding sentence shall be zero. Unless MENTOR and
PERIMMUNE otherwise agree in a writing signed by both of them,
the payment and other provisions set forth in this Agreement
shall supersede those of any subsequent purchase order, sales
confirmation form or other document hereafter sent by either
party hereto to the other.
Within thirty (30) days after the end of each
calendar quarter in which MENTOR has purchased any Product from
PERIMMUNE, MENTOR shall submit a report to PERIMMUNE certified by
a financial officer of MENTOR and setting forth, with respect to
such calendar quarter, (i) the aggregate number of Vials of
Product purchased from PERIMMUNE, (ii) the aggregate number of
Vials of Product sold by MENTOR, (iii) 30% of MENTOR's aggregate
Net Sales from the Product and (iv) the aggregate Advances paid
by MENTOR to PERIMMUNE with respect to the Vials of the Product
sold by MENTOR. Upon thirty (30) days notice to MENTOR,
PERIMMUNE shall have the right to examine the applicable books
and records of MENTOR in order to verify the payments made to
PERIMMUNE pursuant to Section 6.2(b) above. In the event that
any such examination reveals that the amount of such payments
owed to PERIMMUNE for any calendar quarter shall be different
than the amount certified to PERIMMUNE with respect to such
calendar quarter and paid to PERIMMUNE pursuant to Section
6.2(b), then, any shortfall shall promptly be paid to PERIMMUNE
and, alternatively, any overpayment shall promptly be re-paid to
MENTOR, in each case, without interest on such payment. For
purposes of this Section 6.2(c), MENTOR shall maintain such books
and records for not less than three years after the relevant
date.
Title and risk of loss with respect to the Product
sold by PERIMMUNE to MENTOR shall pass to MENTOR upon release of
Product for shipment by PERIMMUNE to the designated carrier.
MENTOR shall specify the method of shipment and insurance and all
freight and applicable insurance charges shall be the
responsibility of MENTOR. PERIMMUNE will be responsible for
contracting freight services specified by MENTOR, for which
MENTOR will be billed on a shipment-by-shipment basis. The
Product is subject to inspection and acceptance by MENTOR upon
receipt. MENTOR shall be deemed to have accepted each shipment
of the Product unless rejected for non-conformity with the
Quality Specifications (as defined herein) in accordance with
Section 6.5 of this Agreement, within twenty (20) working days
after receipt of shipments from PERIMMUNE.
Unless approved by MENTOR in writing, PERIMMUNE
will not sell any Product to MENTOR that has a shelf-life from
the date of shipment by PERIMMUNE that is less than the greater
of (a) twelve (12) months or (b) such longer period for which
PERIMMUNE has obtained stability approval from the FDA.
MENTOR's Duties. MENTOR shall:
use best commercial efforts to advertise and
promote the sale of the Product in a manner calculated by MENTOR
to yield benefit to the parties hereto. MENTOR agrees that
during the term of this Agreement, it will not market any
Competitive Product.
submit its purchase orders to PERIMMUNE in writing
or via facsimile, signed by an authorized representative of
MENTOR.
pay all PERIMMUNE invoices in United States
currency by company check or by electronic wire transfer to an
account designated by PERIMMUNE.
submit to PERIMMUNE a twelve (12) month forecast
of purchases of Product from PERIMMUNE and delivery dates for
such Product, which forecast shall not constitute a firm purchase
commitment, in a format to be mutually determined by the parties.
Said forecast shall be submitted by MENTOR to PERIMMUNE within
thirty (30) days after gaining FDA approval for use in the
Indicated Uses, and quarterly thereafter. MENTOR shall place
firm orders from time to time for the purchase of the Product at
least ninety (90) days in advance of required delivery.
obtain advance written authorization and a
Returned Material Authorization ("RMA") prior to returning any of
the Product.
maintain a properly trained sales force of
adequate size to represent and promote the sale of the Product
and provide instructions to customers in the use of the Product.
MENTOR shall be responsible for developing its own marketing plan
and system for dispensing the Product.
carry in stock an inventory of the Product
sufficient to promptly fill the orders of MENTOR's customers.
pay any import duty or like charge on the entry of
the Product into any jurisdiction and any local or other
applicable taxes.
maintain separate and detailed accurate and
complete records of all transactions in respect of the Product,
including, but not limited to, such records as identify all
customer purchases by Product and serial and/or lot number, and
possess the capability to notify all purchasers in the event of a
Product recall or corrective action.
defray all expenses of and incidental to the
distribution and sale of the Product hereunder incurred by
MENTOR.
make no contracts or commitments on behalf of
PERIMMUNE or make any promises or representations or give any
warranties or guarantees with respect to the Product except as
herein expressly permitted or otherwise incur any liability on
behalf of PERIMMUNE without PERIMMUNE's prior written consent,
nor represent itself as agent or partner of PERIMMUNE.
comply with all laws and regulations and
requirements applicable to a seller of bio-pharmaceutical
products, and with all laws and regulations and requirements of
governmental agencies in any jurisdiction in which it markets,
distributes or sells the Product.
except as authorized in writing by PERIMMUNE,
refrain absolutely from using the trademark or trade name and
logo of PERIMMUNE in connection with the marketing, distribution
and sale of any Product.
PERIMMUNE's Duties. PERIMMUNE shall:
make reasonable best efforts, in good faith, to
deliver MENTOR's firm orders for the Product within ninety (90)
days from date of order receipt, provided that if PERIMMUNE is
unable to deliver such firm orders within such ninety (90) day
period, PERIMMUNE will give priority to the delivery of the
Product to MENTOR to deliver such firm order, over the delivery
of the Product to any other purchaser or distributor, until such
firm orders are filled. MENTOR shall specify the method of
shipment and insurance and PERIMMUNE shall make reasonable best
efforts, in good faith, to comply with such specifications. If
no such specification is made, or if the specification cannot be
reasonably complied with after notice to MENTOR and an
opportunity to resolve the issues surrounding PERIMMUNE's alleged
inability to comply, PERIMMUNE may select a reasonable manner of
shipment and insurance, the cost of which shall be the
responsibility of MENTOR as provided in Section 6.2(d).
afford all purchase orders for the Product
received from MENTOR equal priority with PERIMMUNE's own supply
requirements for (a) products that PERIMMUNE distributes for its
own account and (b) orders from distributors of other products
manufactured by or for PERIMMUNE. PERIMMUNE will ship all orders
for the Product and for other products manufactured by or for
PERIMMUNE in the priority in which such orders were received.
provide such amount of Product as MENTOR
reasonably requests for use by MENTOR for promotional purposes,
to MENTOR, at PERIMMUNE's cost plus shipping charges.
comply with all laws and regulations and
requirements applicable to PERIMMUNE as a manufacturer of bio-
pharmaceutical products.
except as authorized in writing by MENTOR, refrain
absolutely from using the trademark or trade name and logo of
MENTOR in connection with the marketing, distribution and sale of
any Product.
supply the Product to MENTOR in Vials, pre-labeled
with labels of a design provided by MENTOR. MENTOR shall supply
PERIMMUNE with camera-ready artwork for such labels.
provide reasonable technical assistance to
MENTOR's personnel necessary for the marketing of the Product.
at PERIMMUNE's expense, provide MENTOR with
written product inserts relating to the Product's use, and with
such amendments thereto as subsequently become available.
provide necessary documentation to assist MENTOR
in meeting requirements to register the Product in any
jurisdiction where MENTOR reasonably expects to market the
product for sale, and, where possible, allow MENTOR to utilize
prior registrations by PERIMMUNE.
provide MENTOR with copies of the BLA pre-market
notifications submitted for the Product, copies of current
package inserts for the Product, copies of documents describing
specifications for the Product, and copies of all current and
future correspondence with the FDA pertaining to the Product for
any Indicated Use. PERIMMUNE will comply with the FDA's current
good manufacturing practices and regulations ("GMP") in the
manufacture of the Product. If needed to comply with any change
in the law or FDA's GMP regulations or policies, or to enable
MENTOR to market and distribute the Product in any jurisdiction
MENTOR shall have the right to inspect PERIMMUNE's manufacturing
facilities and GMP records pertaining to the manufacture of the
Product. If any action should be taken by the FDA to restrict or
prevent the distribution of the Product for any Indicated Use for
more than thirty (30) days, and such restriction is not due to
the negligence of MENTOR, then upon notice to PERIMMUNE, MENTOR
shall have the right to terminate this Agreement as to such use
or uses of the Product. PERIMMUNE shall replace any affected
inventory of Product under this section or refund to MENTOR the
purchase price it paid to PERIMMUNE for such inventory if
PERIMMUNE is unable to replace the Product with comparable
inventory. PERIMMUNE shall replace or repurchase any affected
inventory of Product which MENTOR replaces or repurchases from
MENTOR's customers, at the price MENTOR paid PERIMMUNE for such
inventory. IN NO CASE SHALL PERIMMUNE BE LIABLE FOR
CONSEQUENTIAL OR INCIDENTAL DAMAGES.
comply with the United States Food, Drug and
Cosmetic Act. The Product comprising each shipment or other
delivery hereafter made by PERIMMUNE to, or on the order of,
MENTOR, as of the date of such shipment or delivery, shall not,
on such date be, adulterated or misbranded within the meaning of
the United States Food, Drug, and Cosmetic Act.
use raw materials that comply with any applicable
raw material specification guidance documents promulgated by the
FDA.
use manufacturing procedures that comply with all
applicable GMP standards.
provide MENTOR with Product that is suitable for
use for its intended purpose.
issue an RMA to MENTOR promptly upon its receipt
of a request therefor, unless a reasonable basis exists for
denying such request, it being understood by the parties hereto
that, the failure of MENTOR to reject a Product within twenty
(20) working days of receipt of the Product shall not constitute
a reasonable basis for denying such request.
(i) consult with MENTOR regarding proposed changes
to the Product and/or the adaptation of the Product for addition
applications within the Indicated Uses, (ii) make such
Improvements to the Product as may be reasonably necessary to
meet the needs of the market and to keep the Product current and
commercially acceptable, and (iii) make reasonable efforts
consistent with its available resources and its other contractual
commitments and business objectives to incorporate into the
Product any features or Improvements that are recommended by
MENTOR as the result of its clinical studies and its marketing
and customer support activities, to the extent that such
Improvements are technically and economically feasible. MENTOR
shall pay a reasonable consulting fee and reasonable costs
incurred by PERIMMUNE, in each case, in an amount mutually
agreeable to the parties, in connection with any research or
development activities that PERIMMUNE undertakes at the request
of MENTOR pursuant to this Section 6.4(p).
if MENTOR exercises its right to terminate this
Agreement pursuant to Section 7.2.1, take reasonable steps,
consistent with the orderly termination of the Project, to reduce
or eliminate as soon as reasonably practicable the costs for
which MENTOR will continue to be responsible under Section 7.2 of
this Agreement, to the extent that PERIMMUNE can do so without
breaching existing contractual obligations or otherwise incurring
liability for wrongful conduct.
Performance Standards.
Quality Specifications and Characteristics.
PERIMMUNE shall deliver to MENTOR Product having the Quality
Specifications.
Certificate of Analysis. Concurrent with
shipment, PERIMMUNE shall fax to MENTOR a Certificate of
Analysis, in the form set forth in Exhibit E hereto, of each lot
of Product sold to MENTOR, confirming that the Product meets the
Quality Specifications.
Product Acceptance. Within twenty (20) working
days of receipt of Product, MENTOR shall take and conduct
analysis of sample of the Product delivered by PERIMMUNE. Should
the result of an analysis of such sample deviate from the Quality
Specifications, MENTOR shall notify PERIMMUNE in accordance with
Section 10.2 hereof and immediately thereafter provide PERIMMUNE
with samples of the Product tested. If, following a review of
the test result and after conducting its own tests of the sample,
PERIMMUNE agrees that such sample does not conform to the Quality
Specifications, PERIMMUNE shall provide to MENTOR, free of any
additional charge, new deliveries of the same quantity of the
Product as the one from which the sample was taken, or in
PERIMMUNE's discretion and at its cost, PERIMMUNE may promptly
reprocess the nonconforming Product to meet the Quality
Specifications. In either event, MENTOR shall return, at
PERIMMUNE's expense, the particular lot or shipment of the
Product which does not comply with the Quality Specifications if
requested to do so by PERIMMUNE.
Product Recall.
Either party shall immediately notify the other
party in writing should it become aware of any defect or
condition that renders any lot(s) of Product supplied by
PERIMMUNE to MENTOR in violation of the United States Food, Drug
and Cosmetic Act, or of a similar law of any jurisdiction or
country where the Product is sold. Should either party
experience any quality problem involving field correction or
recall of any specific lot(s) of Product supplied to MENTOR by
PERIMMUNE, such party shall notify the other in writing by
facsimile within twenty-four (24) hours of the initiation of the
field correction or recall. Each party will test retained
samples of lots in question and report its findings to the other
within ten (10) working days.
Each party shall keep the other informed of any
formal action relating to any specific lot of Product sold to
MENTOR hereunder by a regulatory agency of any state, national
government, or government agency having jurisdiction.
Should any governmental action or other
circumstances require the recall or field corrections or
withholding from market of Product sold by PERIMMUNE to MENTOR,
each party retains the right and obligation to correct field
problems arising out of its fault or omission as it deems
appropriate, with or without the concurrence of the other. All
information about complaints concerning the Product shall be
considered "Confidential Information" under the terms of this
Agreement. MENTOR shall bear all costs of complying or effecting
any recall or field correction, including the cost of the Product
and the actual costs of replacing the Product, that is the result
of any fault or omission attributable to MENTOR. PERIMMUNE shall
bear all costs of complying or effecting any recall or field
correction, including the cost of the Product and the actual
costs of replacing the Product, that (i) is the result of any
fault or omission attributable to PERIMMUNE or (ii) results from
the fault of neither party. Should such recall or field
correction result from the fault of both parties, the parties
shall share all costs of complying or effecting any recall or
field correction, including the costs of the Product and the
actual cost of replacing the Product, in proportion to their
respective degree of fault.
Product Complaints.
PERIMMUNE shall maintain an appropriate record of
all claims made or to be made regarding the Product's
performance. The parties shall share with each other all data on
confirmed lot-specific Product complaints including, but not
limited to, complaints or information regarding performance
and/or allegations or reports of any negative effect from the use
or misuse of such affected lot of Product as soon as such data is
available. Each party will provide reasonable assistance to the
other in resolving customer complaints to the extent the
complaint arises out of any fault or omission of the party whose
assistance is requested. However, MENTOR shall have sole
responsibility and authority to interact directly with MENTOR's
customers in the resolution of such complaints and PERIMMUNE
agrees that it will only interact with MENTOR in such matters.
PERIMMUNE shall evaluate and investigate all
customer complaints in connection with the Product which may be
brought to its attention, in writing, by MENTOR, provided that
such complaints (i) have been confirmed by MENTOR's QA/QC or
technical service personnel using the same standards for
confirmation which MENTOR uses for products other than the
Product and (ii) are believed in good faith by MENTOR to arise
out of a fault or omission attributable to PERIMMUNE. Within
twenty (20) calendar days following receipt from MENTOR of the
original notification of each such complaint, PERIMMUNE agrees to
provide MENTOR with a written interim or final complaint
investigation report. All such Product complaints reported to
PERIMMUNE by MENTOR shall be reviewed monthly by PERIMMUNE until
closure, and a summary report thereof will be provided by
PERIMMUNE to MENTOR.
PERIMMUNE will report to MENTOR all data and/or
information pertaining to adverse reports on any lot of Product
supplied by PERIMMUNE for distribution by MENTOR which would have
a adverse impact on performance of the Product.
Should there be a difference of opinion between
PERIMMUNE and MENTOR regarding whether a field notification or
recall is necessary, MENTOR will exercise the right to notify its
customers without delay.
Packaging and Intellectual Property. MENTOR shall be
responsible for repackaging the Product in such form as is
suitable and in compliance with all applicable laws for resale in
each jurisdiction in which the Product is sold. MENTOR will
distribute the Product only with all appropriate labeling,
packaging and Product literature and only under MENTOR's
applicable trademarks and trade names. MENTOR recognizes
PERIMMUNE's right, title and interest in its patents (including
all Product Patents), trademarks, trade names and copyrights,
trade secrets and proprietary information in connection with the
Product and MENTOR shall not claim any ownership right thereto
inconsistent with this Agreement, or dispute the validity
thereof. In the event any third party shall contest PERIMMUNE's
rights to its patents, trademarks, trade names or copyrights,
trade secrets or proprietary rights, MENTOR shall, at PERIMMUNE's
sole expense, render reasonable assistance to PERIMMUNE in
defending such claims.
Product Modifications. PERIMMUNE reserves the right,
from time to time, to modify the Product or to make any
Improvement, and shall give MENTOR at least three (3) months
prior written notice before making any Improvement or change to
its manufacturing process for the Product that would have an
impact on any of PERIMMUNE's product verifications or
validations, or changes in raw materials that would alter the use
of the Product for any Indicated Use or other change or
Improvement that could impact product labeling or promotional
literature; provided, however, that PERIMMUNE shall be required
to provide MENTOR with only reasonable advance notice where such
modification or Improvement is required to comply with any
applicable legal or regulatory requirement or the unanticipated
modification or unavailability of raw material.
Appointment of Sub-Distributors. MENTOR may assign,
sublicense, delegate, or otherwise transfer the performance of
the rights and obligations hereunder to qualified and reputable
sub-distributors, provided, however, that: (i) MENTOR shall be
liable to PERIMMUNE for the errors, negligent acts and omissions
of its sub-distributors as if such errors, negligent acts and
omissions were its own, including any breach of any provision of
this Agreement by the sub-distributors; (ii) MENTOR shall have
and retain full control of any sub-distributor utilized, and
shall be responsible for the performance by any sub-distributor;
and (iii) MENTOR shall not be relieved of the responsibility for
the proper performance and completion of the sub-distributed
portions of its obligations hereunder.
ARTICLE
TERM AND TERMINATION
Term. This Agreement shall be in full force and effect
in each applicable jurisdiction, and for each applicable
Indication Use, for a period commencing on the Effective Date and
continuing for a period equal to ten (10) years following the
obtaining of the first Approval of the Product for such Indicated
Use in such jurisdiction, provided that, MENTOR shall have the
right to terminate this agreement with respect to any such
Indicated Use in any such jurisdiction at the expiration of five
(5) years from the date of such Approval in such jurisdiction by
giving not less than one-hundred and eighty (180) days written
notice to PERIMMUNE of its intention to so terminate.
Termination.
Termination by MENTOR Without Cause. MENTOR shall
be entitled to terminate this Agreement without cause at any time
prior to attainment of the Project Objective by giving PERIMMUNE
not less than one-hundred and eighty (180) days prior written
notice of intention to terminate, specifying the effective date
of termination, if MENTOR reasonably concludes that the Project
Objective cannot be attained within the Target Period, for a
reason other than excusable delay and events of force majeure, at
a cost that does not exceed the Project Budget as adjusted by the
parties as described herein. Should MENTOR exercise the
termination right conferred by this Section 7.1, then:
MENTOR shall remain liable for the
payment of any costs or expenses that PERIMMUNE
reasonably incurs in the winding down and terminating
of the Project Development Activities, including
amounts payable pursuant to contracts and agreements
entered into by PERIMMUNE prior to receiving notice of
intention to terminate, provided that nothing in this
Section 7.2.1(i) shall cause MENTOR to be liable for
obligations of PERIMMUNE under contracts with
institutions acting as investigators in the clinical
trials conducted pursuant to this Agreement, which
obligations are inconsistent with current industry
practice in the conduct of clinical trials.
MENTOR shall not have the right to the
return of any funds previously expended by it pursuant
to this Agreement; and
MENTOR shall have no rights in the
Product or the Project Information and PERIMMUNE shall
be free to license the right to manufacture, market and
sell the Product to any other persons as PERIMMUNE may
select without further duty or obligation to MENTOR.
Termination by MENTOR With Cause. MENTOR shall be
entitled to terminate this Agreement for cause by giving
PERIMMUNE written notice of intention to terminate, specifying
the effective date of termination not less than ninety (90) days
prior to the effective date of termination, upon the occurrence
of any of the following events:
PERIMMUNE commits a material breach of
its obligations under this Agreement and such material
breach remains uncured for a period of ninety (90) days
after written notice of such default, specifying the
nature thereof, has been given to PERIMMUNE, unless,
prior to the expiration of such ninety (90) day period,
PERIMMUNE has commenced, and thereafter pursues with
diligence to completion, those actions necessary to
cure such default within a reasonable period of time.
PERIMMUNE becomes insolvent or has a
receiver, liquidator, trustee or assignee in bankruptcy
or insolvency appointed, in each case whether by the
voluntary act or otherwise, and, in the case of any
such proceeding that is involuntary, if such proceeding
is not terminated within thirty (30) days thereafter.
An order is made or a resolution is
passed for the winding up or liquidation of PERIMMUNE.
Termination by PERIMMUNE With Cause. PERIMMUNE
shall be entitled to terminate this Agreement for cause by giving
MENTOR written notice of intention to terminate, specifying the
effective date of termination not less than ninety (90) days
prior to the effective date of termination, upon the occurrence
of any of the following events:
MENTOR commits a material breach of its
obligations under this Agreement and such material
breach remains uncured for a period of ninety (90) days
after written notice of such default, specifying the
nature thereof, has been given to MENTOR, unless, prior
to the expiration of such ninety (90) day period,
MENTOR has commenced, and thereafter pursues with
diligence to completion, those actions necessary to
cure such default within a reasonable period of time.
MENTOR becomes insolvent or has a
receiver, liquidator, trustee or assignee in bankruptcy
or insolvency appointed, in each case whether by the
voluntary act or otherwise, and, in the case of any
such proceeding that is involuntary, if such proceeding
is not terminated within thirty (30) days thereafter.
An order is made or a resolution is
passed for the winding up or liquidation of MENTOR.
Procedures on Termination. Upon termination of this
Agreement:
each party shall return to the other party all
Confidential Information (as defined herein) which such other
party shall have supplied to the party and which is in the
party's possession.
the rights and duties of each party under this
Agreement in respect of performance prior to termination shall
survive and be enforceable in accordance with the terms of this
Agreement.
within thirty (30) days of receipt of PERIMMUNE's
invoice therefor, MENTOR will pay PERIMMUNE for all remaining
inventory of the Product for which MENTOR has issued purchase
orders to PERIMMUNE. Upon payment, PERIMMUNE will ship such
inventory to MENTOR at MENTOR's expense, and MENTOR shall be
entitled to continue to market and sell the Product until
MENTOR's inventory of the Product has been disposed of.
If this Agreement has been terminated by reason of
a material breach by PERIMMUNE, adjudicated as provided by
Section 7.4(iv), PERIMMUNE shall continue to be bound by the
provisions of Section 6.1 of this Agreement for the same period
of time during which PERIMMUNE would have been bound had such
termination not occurred.
Procedures on PERIMMUNE's Discontinuance of
Manufacture. MENTOR shall have the right to exercise the license
granted pursuant to Section 4.2, above, if PERIMMUNE (i) abandons
the Project Development Activities without the concurrence of
MENTOR; (ii) discontinues manufacturing the product for valid
business reasons that cannot be remedied within a reasonable
period of time; (iii) is otherwise unable to supply the
requirements of MENTOR for the Product on forecasted delivery
dates, as such requirements and delivery dates are set forth in
the twelve (12) month forecast of purchases submitted by MENTOR
to PERIMMUNE pursuant to Section 6.3(d) of this Agreement for a
period of two successive quarters; or (iv) is in material breach
of this Agreement, which material breach has been determined by a
court of law, which determination has become final and not
subject to further appeal. Upon the occurrence of any such
event, PERIMMUNE shall transfer to MENTOR any necessary
technology, knowledge, know-how, and the rights to the Approvals
for the Product for use in the Indicated Uses, to the extent
necessary or appropriate to enable MENTOR or its alternate
supplier to exercise the license granted under Section 4.2.
MENTOR shall reimburse PERIMMUNE the reasonable out-of-pocket
costs PERIMMUNE incurs in doing so (including salary benefits for
time expended by PERIMMUNE employees) immediately upon receipt of
an invoice therefor. If any such event occurs before the
issuance of an Approval for an Indicated Use, then PERIMMUNE
shall transfer to MENTOR all Project Information relating to such
Indicated Use.
ARTICLE
WARRANTIES
Representations and Warranties of MENTOR. MENTOR
hereby makes the following representations and warranties to
PERIMMUNE, which representations and warranties are true and
correct on the date hereof:
MENTOR is a corporation duly organized, validly
existing and in good standing under the laws of the state of
Minnesota and has all requisite corporate power and authority to
enter into this Agreement and perform its obligations hereunder.
Neither the execution or delivery of this
Agreement, nor the consummation of the transactions contemplated
herein, will (a) violate or conflict with any provision of the
Certificate of Incorporation or By-laws of MENTOR, each as in
effect on the Effective Date; (b) with or without the giving of
notice of the lapse of time or both (i) result in a breach of, or
violate, or be in conflict with or constitute a default under, or
result in the termination or cancellation of, or accelerate the
performance required under, any security instrument, mortgage,
note, debenture, indenture, loan, lease contract, agreement or
other instrument, to which MENTOR is a party or by which it or
any of its properties or assets may be bound or affected, or (ii)
result in the loss or adverse modification of any lease,
franchise, license or other contractual right or other
authorization granted to or otherwise held by MENTOR; (c) require
the consent of any party to any such agreement or commitment to
which MENTOR is a party or by which any of its properties or
assets are bound; (d) result in the creation or imposition of any
lien, claim or encumbrance upon any property or assets of MENTOR;
or (e) require any consent, approval, authorization, order,
filing, registration or qualification of or with any court or
governmental authority or arbitrator to which MENTOR is subject
or by which any of its properties or assets may be bound or
affected, other than Approvals of the Product for the Indicated
Uses, as contemplated herein.
All action to authorize the execution and delivery
of this Agreement and the consummation of the transactions
contemplated herein have been duly taken, and this Agreement
constitutes the valid and binding obligation of MENTOR
enforceable in accordance with its terms.
There are no claims relating to patent
infringement or any other matters, actions, suits, proceedings,
arbitrations or investigations pending or, to the best of
MENTOR's knowledge, threatened, against MENTOR which if adversely
determined would adversely affect MENTOR's ability to sell the
Product for any Indicated Use, or MENTOR's ability to conduct
Product Development or to enter into or carry out this Agreement.
Representations and Warranties of PERIMMUNE. PERIMMUNE
hereby makes the following representations and warranties to
MENTOR, which representations and warranties are true and correct
on the date hereof.
PERIMMUNE is a corporation duly organized, validly
existing and in good standing under the laws of the state of
Delaware and has the power and authority to enter into this
Agreement and perform its obligations hereunder.
Neither the execution or delivery of this
Agreement, nor the consummation of the transactions contemplated
herein, will (a) violate or conflict with any provision of the
Certificate of Incorporation or By-laws of PERIMMUNE, each as in
effect on the Effective Date; (b) with or without the giving of
notice of the lapse of time or both (i) result in a breach of, or
violate, or be in conflict with or constitute a default under, or
result in the termination or cancellation of, or accelerate the
performance required under, any security instrument, mortgage,
note, debenture, indenture, loan, lease contract, agreement or
other instrument, to which PERIMMUNE is a party or by which it or
any of its properties or assets may be bound or affected, or (ii)
result in the loss or adverse modification of any lease,
franchise, license or other contractual right or other
authorization granted to or otherwise held by PERIMMUNE; (c)
require the consent of any party to any such agreement or
commitment to which PERIMMUNE is a party or by which any of its
properties or assets are bound; (d) result in the creation or
imposition of any lien, claim or encumbrance upon any property or
assets of PERIMMUNE; or (e) require any consent, approval,
authorization, order, filing, registration or qualification of or
with any court or governmental authority or arbitrator to which
PERIMMUNE is subject or by which any of its properties or assets
may be bound or affected, other than Approvals of the Product for
the Indicated Uses, as contemplated herein.
All action to authorize the execution and delivery
of this Agreement and the consummation of the transactions
contemplated herein have been duly taken, and this Agreement
constitutes the valid and binding obligation of PERIMMUNE
enforceable in accordance with its terms.
There are no claims relating to patent
infringement or any other matters, actions, suits, proceedings,
arbitrations or investigations pending or, to the best of
PERIMMUNE's knowledge, threatened, against PERIMMUNE which if
adversely determined would adversely affect the use of the
Product for any Indicated Use, or PERIMMUNE's ability to enter
into or carry out this Agreement.
PERIMMUNE, after having made a reasonable
investigation and obtaining the advice of its counsel, (i) has no
knowledge that the manufacture, use, importation or sale of the
Product for the Indicated Uses under this Agreement, either alone
or in combination, infringes any patent or other industrial
property right of a third party; and (ii) has not received any
notification from any third party alleging or suggesting that the
manufacture, use, importation or sale of the Product does or
would infringe any patent or other industrial property.
PERIMMUNE shall disclose to MENTOR any information regarding
adverse patent rights of which it is, or becomes, aware relating
to the Product.
ARTICLE
INDEMNIFICATION
PERIMMUNE Indemnification. PERIMMUNE shall defend,
indemnify and hold harmless MENTOR and its directors, employees,
representatives and agents from and against all suits, claims,
liabilities, damages, demands and costs (including, but not
limited to, reasonable legal expenses) ("Claims") incurred as a
result of:
any claims of or on behalf of third parties for
death or personal injury resulting from the Product; provided,
however, that this indemnity shall not apply to, and PERIMMUNE
shall not be liable for, any such claim caused by or arising
from:
any act or failure on the part of
MENTOR, its Affiliates, or their respective employees,
representatives, agents or subsidiaries (the "MENTOR
Parties") in packaging, handling, storing or otherwise
distributing the Product;
any representation or warranty
concerning the Product made by or on behalf of MENTOR
or any MENTOR Party and not specifically authorized by
PERIMMUNE;
any claim resulting from the use of the
Product by any customer that was not in accordance with
the use presented by PERIMMUNE;
MENTOR's failure to disseminate to
purchasers or end-users any Product information which
PERIMMUNE has made available to MENTOR;
any claim where PERIMMUNE has not been
notified in writing within forty five (45) days of
MENTOR's first notice of this claim;
any claim where MENTOR fails to furnish
evidence in its possession or fails to fully cooperate
with PERIMMUNE in preparing the defense;
any claim that the Product or any activities
hereunder infringe the patent or other intellectual property
rights of any third party provided MENTOR gives PERIMMUNE notice
within forty-five (45) days of MENTOR's first notice of the
claim; provided, however, that the claim is not based on (i) the
sale or use of the Product in combination with any other product
which is not specifically authorized by PERIMMUNE in writing; and
PERIMMUNE's material breach of the terms of this
Agreement.
MENTOR Indemnification. MENTOR shall defend, indemnify
and hold harmless PERIMMUNE and its directors, employees,
representatives and agents from and against all Claims incurred
as a result of:
MENTOR's material breach of the terms of this
Agreement.
Indemnification Proceedings.
Notice of Claims: Assumption of Defense. The
party to be indemnified ("the Indemnified Party") shall give
prompt notice to the other party ("the Indemnifying Party") of
the assertion of any Claim in respect of which indemnity may be
sought hereunder (and in any event within fifteen (15) calendar
days after the service of the citation or summons). It is
understood, however, that the Indemnified Party shall be
authorized and expected to take any such prompt action as may be
reasonably necessary in the circumstances of any proceedings
seeking an injunction or similar equitable relief against it.
The Indemnifying Party may, at its own expense (i) participate in
the defense of any Claim for which it is obligated to indemnify
the Indemnified Party hereunder and (ii) upon notice to the
Indemnified Party at any time during the course of any such
Claim, assume the defense thereof; provided, however, that
(i) the Indemnifying Party's counsel is reasonably satisfactory
to the Indemnified Party and (ii) the Indemnifying Party shall,
upon reasonable request, thereafter consult with the Indemnified
Party from time to time with respect to such Claim. If the
Indemnifying Party assumes such defense, the Indemnified Party
shall have the right (but not the duty) to participate in the
defense thereof and to employ counsel, at its own expense,
separate from the counsel employed by the Indemnifying Party.
Whether or not the Indemnifying Party chooses to defend or
prosecute any such Claim, both parties hereto shall cooperate in
the defense or prosecution thereof.
Settlement or Compromise. Any settlement or
compromise made or caused to be made by the Indemnified Party or
the Indemnifying Party (as the case may be) of any Claim shall be
binding upon the Indemnifying Party or the Indemnified Party (as
the case may be) in the same manner as if a final judgment or
decree has been entered by a court of competent jurisdiction in
the amount of such settlement or compromise; provided however,
that no obligation, restriction or loss shall be imposed on an
Indemnified Party as a result of such settlement without its
prior written consent which consent shall not be unreasonably be
withheld, and such settlement shall include an unconditional
release of the Indemnified Party; and provided further, that the
Indemnified Party shall not make or cause to be made any such
settlement or compromise without the prior written consent of the
Indemnifying Party, which consent shall not unreasonably be
withheld. The Indemnified Party will give the Indemnifying Party
at least thirty (30) days' prior written notice of any proposed
settlement or compromise of any Claim it itself is defending,
during which time the Indemnifying Party may assume the defense
of, and responsibility for, such Claim and, if it does so, the
proposed settlement or compromise may not be made.
Failure of Indemnifying Party to Act. In the
event that the Indemnifying Party does not elect to assume the
defense of any claim or to cause the same to be done, then any
failure of the Indemnified Party to defend or participate in the
defense of any such claim or to cause the same to be done, shall
not relieve the Indemnifying Party of its obligations hereunder;
provided however, that the Indemnified Party shall have given the
Indemnifying Party at least thirty (30) days' notice of its
proposed failure to defend or participate and afford the
Indemnifying Party the opportunity to assume defense thereof
prior to the end of such period.
Procedure for Indemnification. Upon becoming
aware of any claim for indemnification, the Indemnified Party
shall promptly give notice of such claim (a "Claim Notice") to
the Indemnifying Party and will provide, to the extent possible
and without prejudice to the rights of the Indemnified Party
hereunder, a good faith estimate of the amount the Indemnified
Party reasonably anticipates that it will be entitled to on
account of indemnification by the Indemnifying Party. If the
Indemnifying Party does not object to such indemnification claim
within forty-five (45) days of receiving notice thereof, the
Indemnified Party shall be entitled to recover promptly the
amount of such claim (but such recovery shall not limit the
amount of any additional indemnification or other rights to which
the Indemnified Party may be entitled pursuant to this Article
IX). If, however, the Indemnifying Party advises the Indemnified
Party that it disagrees with the Indemnified Party's claim, the
parties shall, for a period of forty five (45) days after the
Indemnifying Party advises the Indemnified Party of such
disagreement, attempt to resolve the difference. If the parties
are unable to reach agreement within such forty five (45) days,
the disagreement shall be resolved pursuant to Section 10.8
hereof.
Limitations. No claim for indemnification shall
be valid unless first made in writing within forty-five (45) days
of the Indemnified Party's first notice of such claim.
ARTICLE
MISCELLANEOUS
Confidentiality.
Confidentiality Defined. For the purposes of this
Agreement, the term "Confidential Information" shall be any
information embodying concepts, ideas, techniques, proprietary
information, know-how, formulations, market data, customer lists,
product specifications and accounting data which:
is disclosed by one party hereto to the
other;
is claimed by the disclosing party to be
secret, confidential and proprietary to the disclosing
party; and
if disclosed in writing, is marked by
the disclosing party to indicate its confidential
nature or, if disclosed orally as confidential, is
confirmed in writing by the disclosing party to be
confidential within ten (10) days following disclosure.
Non-Disclosure. During the period that this
Agreement remains in effect and for a period of three (3) years
following termination hereof, each party (except as is explicitly
otherwise required hereby) shall keep confidential, shall not use
for itself or for the benefit of others and shall not copy or
allow to be copied in whole or in part any Confidential
Information disclosed to such party by the other. The obligation
of confidentiality imposed upon the parties by the foregoing
paragraph shall not apply with respect to any alleged
Confidential Information which:
is known to the recipient thereof, as
evidenced by said recipient's written records, prior to
receipt thereof from the other party hereto;
is disclosed to said recipient after the
date hereof by the third party who has the right to
make such disclosures and who does not violate any
confidentiality agreement with the affected party
hereto;
is or becomes a part of the public
domain through no fault of the said recipient; or
is required by law or judicial or
administrative process to be disclosed.
Non-Disclosure of Relationship. PERIMMUNE and
MENTOR shall agree to keep confidential and not disclose to third
parties, the supply and working relationship under this
Agreement.
Limited Use of Confidential Information. Each
party agrees to limit access to Confidential Information to
employees and agents having a need to know and to protect
Confidential Information to the same extent as it protects its
own trade secrets.
Notices. Any notices or report or other communication
permitted or required under this Agreement shall be in writing
and sent by certified mail, express mail; Federal Express,
postage paid, return receipt requested, addressed to the party to
whom the notice is to be given. All notices, reports or other
communications made hereunder shall be deemed to have been made
on the date postmarked. Changes in address shall be accomplished
by a notice in compliance with this Section 10.2. The current
address for each party is as follows:
PERIMMUNE MENTOR Corporation
0000 Xxxxxxx Xxxxx 0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000- Santa Barbara, California
4396 93111
Attn: Xx. Xxxxx Xxxxxx Attn: Xx. Xxxxxxx Xxxxx
Binding Effect. This Agreement shall be binding upon
and shall inure to the benefit of each of the parties and their
respective heirs, successors, assigns and legal representatives.
Either party may freely assign this Agreement to any Affiliate,
and either party shall have the right to assign its rights and
licenses and to delegate its duties under this Agreement to any
third party who (a) purchases all or substantially all of the
business assets of the assignor or who succeeds to the business
of the assignor by reason of a merger or consolidation and (b)
agrees to assume the duties and obligations of the assignor
hereunder. Except as expressly provided herein, no party hereto
shall have the right to transfer or assign its interest in this
Agreement without the prior written consent of the other party
hereto, which consent may not be unreasonably withheld. The
assignment by either party of any rights under this Agreement
shall not relieve the assigning party from any of its obligations
under this Agreement.
Force Majeure. Neither party shall be liable in
damages for, nor shall this Agreement be terminable or cancelable
by reason of any delay or default in such party's performance
hereunder if such default or delay is caused by events beyond
such party's reasonable control including, but not limited to,
acts of God, regulation or law or other action of any government
or agency thereof, war or insurrection, civil commotion,
destruction or production facilities or materials by earthquakes,
fire, flood or storm, labor disturbances, epidemic, or failure of
supplies, public utilities or common carriers. Each party shall
endeavor to resume its performance hereunder if such performance
is delayed or interrupted by reason of force majeure. Each party
shall notify the other, in writing, not less often than monthly,
of the nature of progress of such endeavors.
Insurance. Each party shall keep in force during the
term of this Agreement, and for a period of three (3) years
following its termination, product liability insurance in such
amounts as may be customary for like-sized businesses undertaking
like responsibilities to those contemplated by this Agreement.
Each party shall submit a certificate of insurance to the other
evidencing such coverage upon written request therefor.
Severability. Should any part of this Agreement be
held unenforceable or in conflict with the applicable laws or
regulations of any jurisdiction, the invalid or unenforceable
part or provision shall be replaced with a provision which
accomplishes, to the extent possible, the original business
purpose of such part or provision in a valid and enforceable
manner, and the remainder of this Agreement shall remain binding
upon the parties.
Waiver. Waiver by either party of a default or breach
or a succession of defaults or breaches, or any failure to
enforce any right hereunder shall not be deemed to constitute a
waiver of any subsequent default or breach with respect to the
same or any other provision hereof, and shall not deprive such
party of any right to terminate this Agreement arising by reason
of any subsequent default or breach.
Mediation. Unless the relief sought requires the
exercise of the equity powers of a court of competent
jurisdiction, neither party shall commence any action or
proceeding to construe or enforce the terms and conditions of
this Agreement unless such party has first given written notice
of its intention to do so and submitted such matter to non-
binding mediation if the other party desires to have the
controversy mediated. Any party who receives from the other
party (a) a notice of default under this Agreement, or a notice
that such other party intends to submit a controversy or dispute
for adjudication, shall have a period of fifteen (15) days after
its receipt of such notice to request that the dispute or
controversy be submitted to mediation, and the failure of the
recipient of any such notice to make a written request for
mediation within such fifteen (15) day period shall be deemed to
have waived its right to require that such matter be submitted to
mediation. The period during which any such matter is being
mediated shall not toll the period during which any party who is
in default in the performance of its obligations under this
Agreement is obligated to remedy or cure such default.
Venue and Jurisdiction. The parties hereto (a)
mutually consent and stipulate that any action or proceeding
commenced to interpret or enforce this Agreement or the rights
and duties of the parties hereunder shall be commenced and
conducted in a state or federal court of competent jurisdiction
situated in the county or judicial district in which the
defendant in such action or proceeding has its corporate
headquarters, (b) each waive any claim that any such state or
federal court is an inconvenient forum, and (c) each irrevocable
agree that any and all actions or proceedings arising out of or
relative to this Agreement or from transactions contemplated
herein shall be exclusively heard only in such state or federal
court.
Governing Law. This Agreement, the construction and
enforcement of its terms, and the interpretation of the rights
and duties of the parties hereunder shall be governed by and
interpreted in accordance with the laws of the State of Maryland
without regard to the choice of law rules utilized in that
jurisdiction.
Costs of Enforcement. Should any action or proceeding
be necessary to construe or enforce this Agreement, then the
party prevailing in any such action or proceeding shall be
entitled to recover all court costs and reasonable attorneys'
fees, to be fixed by the court and taxed as part of any judgment
entered therein, and the costs and fees incurred in enforcing or
collecting any such judgment.
Entire Agreement. This Agreement represents the entire
understanding between the parties as of the Effective Date with
respect to the subject matter hereof, and supersedes all prior
agreements, negotiations, understandings, representations,
statements, and writings, between the parties relating thereto.
No modification, alteration, waiver or change in any of the terms
of this Agreement shall be valid or binding upon the parties
hereto unless made in writing and specifically referring to this
Agreement and duly executed by each of the parties hereto.
IN WITNESS WHEREOF, the parties hereto have caused this
Agreement to be executed in duplicate by their duly authorized
representatives as of the day and year first written above.
PERIMMUNE, INC. MENTOR CORPORATION
By: /s/XXXXXXX X. XXXXX By: /s/XXXXXXXXXXX XXXXXX
Name: Xxxxxxx X. Xxxxx Name: Xxxxxxxxxxx Xxxxxx
Title: President Title: Chairman, CEO
