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EXHIBIT 10.23
DISTRIBUTION AGREEMENT BETWEEN PERIMMUNE, INC.,
AND MENTOR CORP.
This Exclusive Distribution Agreement (hereinafter the "Agreement") is
made in Rockville, Maryland, by and between PerImmune, Inc. (hereinafter
"PERIMMUNE"), a corporation existing under the laws of Delaware, and MENTOR
Corp. (hereinafter "MENTOR"), a corporation existing under the laws of
Minnesota.
WHEREAS, PERIMMUNE desires to sell and/or market its AuraTek-FDP Bladder
Cancer Diagnostic product and MENTOR desires to purchase PERIMMUNE's product
for resale to customers bearing a trademark or trade name and logo owned by
MENTOR; and
WHEREAS, the parties desire to enter into an agreement setting forth the
terms of their relationship;
NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, the parties do hereby agree as follows:
1. Product. The product of PERIMMUNE covered by this Agreement is set forth
on Exhibit A attached hereto (hereinafter the "Product") and any future
modifications or improvements thereto. PERIMMUNE reserves the right to
modify the Product from time to time, and shall give MENTOR at least six
(6) months prior written notice before making changes to its
manufacturing process that would have an impact on any of PERIMMUNE's
product verifications or validations, or changes in raw materials that
would alter the operating principle of the Product or other changes 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 is required to comply
with any applicable legal or regulatory requirement or the unanticipated
modification or unavailability of raw material.
2. Appointment and Acceptance. PERIMMUNE hereby grants MENTOR the exclusive
right to distribute the Products in the United States, and outside the
United States (the "Territory").
3. Term and Renewal. The term of this Agreement shall be for a period of
five (5) years, commencing on the Effective Date (the "Initial Term").
"Effective Date" means the date on which this Agreement is executed. This
Agreement shall automatically renew for additional and successive terms
of one (1) year unless either party provides written notice on
non-renewal at least six (6) months prior to the close of the Initial
Term or any anniversary date thereafter.
4. Terms of Sale.
(a) MENTOR shall fix the price of the individual Product sold hereunder.
On a monthly basis, MENTOR shall pay to PerImmune, in United States
Dollars, fifty
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percent (50%) of the Net Sales, as defined below, received by MENTOR
from the sale of the Product, less the Advances, as hereinafter
defined, paid by MENTOR to PerImmune during such month. For purposes
herein, "Advances" shall mean an amount equal to 25% of the list
price, per kit, paid by MENTOR to PerImmune within 30 days of
MENTOR's receipt of kits ordered by it. 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. For
purposes hereof, Net Sales shall mean the gross invoiced price for
the sales of the Products to Purchasers by MENTOR, its agents or
affiliates ("Gross Sales") 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.
(b) Within thirty (30) days after the end of each month MENTOR shall
submit a report to PERIMMUNE setting forth the (i) cumulative
number of kits purchased from PERIMMUNE through the end of the
preceding month (ii) 50% of net sales price for each such kit sold
through the end of the preceding month, (iii) the advances
previously paid for such kits. Each such report shall be
accompanied by payment of the difference between (ii) and (iii).
(c) Title and risk of loss shall pass to MENTOR upon release of Product
for shipment by PERIMMUNE to the designated carrier. All freight and
applicable insurance charges shall be the responsibility of MENTOR.
PERIMMUNE will be responsible for contracting freight services, in
accordance with Section 8(a) of this Agreement, for which MENTOR
will be billed on a shipment by shipment basis. Product is subject
to inspection and acceptance by MENTOR upon receipt. MENTOR shall be
deemed to have accepted all shipments of Product unless rejected for
non-conformity with the Quality Specifications, as hereinafter
defined, in accordance with Article 9 of this Agreement, within
twenty (20) working days after receipt of shipments from PERIMMUNE.
(d) Unless approved by MENTOR in writing, PERIMMUNE will not sell any
Product to MENTOR as of the effective date hereof that has less
than eighteen (18) months shelf-life from date of shipment by
PERIMMUNE.
5. Termination. Should any of the following events occur, the affected party
may terminate this Agreement by giving notice, in writing to be effective
on the date specified in the notice, namely,
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(a) failure to either party to observe any of the terms hereof to a material
extent and to remedy the same (where it is capable to being remedied)
after having received reasonable notice from the aggrieved party and a
reasonable opportunity to cure;
(b) either party becoming insolvent or having a receiver appointed of its
assets, or execution or distress levied upon its assets;
(c) an order being made or a resolution being passed for the winding up or
liquidation of either party;
(d) if PERIMMUNE discontinues manufacturing the product for valid business
reasons that cannot be remedied during the term of this Agreement then (i)
at the request of MENTOR, PERIMMUNE shall assist MENTOR in establishing an
alternative source of supply and shall transfer any necessary technology or
knowledge to MENTOR or its alternative supplier provided that MENTOR
reimburses PERIMMUNE the out-of-pocket costs of doing so (including salary
and benefits for time expended by PERIMMUNE employees, (ii) or if the
discontinuation occurs during the first three years MENTOR can receive the
return of its investment at its election. Nothing herein is intended to
permit PERIMMUNE to breach its obligation under the agreement.
6. Procedures on Termination. Upon termination or non-renewal of this
Agreement:
(a) MENTOR shall return to PERIMMUNE all literature which PERIMMUNE shall have
supplied to MENTOR and which is in its possession.
(b) the rights and duties of each party under this Agreement in respect of
performance prior to termination or non-renewal shall survive and be
enforceable in accordance with the terms of this Agreement.
(c) within thirty (30) days of receipt of PERIMMUNE's invoice therefor, MENTOR
will pay PERIMMUNE for all remaining inventory of Product for which MENTOR
has issued purchase orders to PERIMMUNE. Upon payment, PERIMMUNE will ship
such inventory to MENTOR at MENTOR's expense.
7. MENTOR's Duties. MENTOR shall:
(a) 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 in light of the prevailing circumstances and to the extent to which
any products are at the relevant time competitive with other products.
MENTOR agrees that during the term of this Agreement, it will not market
any product using the same technology which detects the same analyte and
thereby directly competes with a Product.
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(b) submit its purchase orders to PERIMMUNE in writing or via facsimile, signed
by an authorized representative of MENTOR.
(c) pay all PERIMMUNE invoices in United States currency by company check.
(d) submit to PERIMMUNE a twelve (12) month forecast of purchases delivery
dates from PERIMMUNE for the Product in a format to be mutually determined
by the parties. Said forecast shall be submitted by MENTOR to PERIMMUNE
within thirty (30) days of commencement of the term of this Agreement, and
quarterly thereafter.
(e) obtain advance written authorization and a Returned Material Authorization
("RMA") prior to returning any of the Product.
(f) 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.
(g) carry in stock an inventory of Product sufficient to promptly fill the
orders of MENTOR's customers in the Territory.
(h) apply for and obtain all necessary licenses, permits and other
authorizations required by local law or regulation in relation to the
promotion, marketing, distribution and supply of the Product in any
jurisdiction or country in which MENTOR sells the Product.
(i) pay any import duty or like charge on the entry of the Product into the
Territory and any local or other applicable taxes.
(j) 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.
(k) defray all expenses of and incidental to the distribution and sale of
Product hereunder incurred by MENTOR.
(l) 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
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represent itself as agent or partner of PERIMMUNE.
(m) comply with all laws and regulations and requirements applicable to
a seller of in-vitro diagnostics products, and with all laws and
regulations and requirements of governmental agencies having
jurisdiction with the Territory.
(n) 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.
8. PERIMMUNE's Duties. PERIMMUNE shall:
(a) make reasonable best efforts, in good faith, to ship MENTOR's
orders for Product within thirty(30) days from date of order
receipt. 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.
(b) at the time of shipment, the product will have a remaining shelf
life of not less than 16 months.
(c) will provide up to 12,000 units per year of product at PERIMMUNE's
cost plus shipping charges to be used by MENTOR for promotional
purposes at no reimbursement to MENTOR.
(d) comply with all laws and regulations and requirements applicable
to PERIMMUNE as a manufacturer of in-vitro diagnostic products.
(e) 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.
(f) provide reasonable technical assistance to MENTOR's personnel
necessary for the marketing of the Product.
(g) 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.
(h) provide necessary documentation to assist MENTOR in meeting
requirements to
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register Products in the Territory, and where possible, allow MENTOR
to utilize prior registrations by PERIMMUNE.
(i) provide MENTOR with copies of the 510(k) premarket notifications
submitted for the Product, copies of current package insert 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. PERIMMUNE will comply with the
FDA's current GMP regulations in the manufacture of the Product, if
those regulations are modified to include components of finished
devices. If needed to comply with any change in the law or FDA's GMP
regulations or policies, MENTOR shall be given 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 any of the Product
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 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.
(j) comply with the Federal 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 be, on such date, not adulterated or
misbranded within the meaning of the Federal Food, Drug, and
Cosmetic Act.
9. Performance Standards.
(a) Quality Specifications and Characteristics. PERIMMUNE shall deliver
to MENTOR Product having the quality specifications agreed upon by
the parties as set forth in Exhibit B (the "Quality
Specifications").
(b) Certificate of Analysis. Concurrent with shipment, PERIMMUNE shall
fax to MENTOR a Certificate of Analysis, in the form set forth in
Exhibit B, for each lot of Product sold to MENTOR, confirming that
the Product meets the Quality Specifications.
(c) Product Acceptance. Within twenty (20) working days of receipt of
Product,
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MENTOR shall take and conduct analysis of samples of 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 Article 4(c) hereof and immediately
thereafter provide PERIMMUNE with samples of the Product tested. If,
following a review of the test results and after conducting its own
tests of the sample, PERIMMUNE agrees that such sample does not
conform to the Quality Specifications, PERIMMUNE shall provide
MENTOR, free of any additional charge, with 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.
10. PRODUCT RECALL.
(a) PERIMMUNE shall maintain an appropriate record of all claims made or
to be made regarding the Product's performance.
(b) Each party shall keep the other informed of any formal action
relating to any specific lot of Product sold to MENTOR hereunder by
an regulatory agency of any state, national government, or
government agency having jurisdiction.
(c) Should any governmental or corporate action require the recall or
field corrections or withholding from market of Product sold by
PERIMMUNE to MENTOR, MENTOR shall bear the reasonable, direct costs
and expenses of recall or field correction if such recall or field
correction is the result of any fault or omission attributable to
MENTOR and PERIMMUNE shall bear the cost of products and the actual
costs of replacing the Product if such recall or field correction is
the result of any fault or omission attributable to PERIMMUNE.
Should such recall or field correction result from the fault of both
parties, the parties shall share the costs of Products and the
actual cost of replacing the Products in proportion to their
respective degree of fault.
11. PRODUCT COMPLAINTS.
(a) 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 will notify the other in writing by
facsimile within twenty-four (24) hours of the initiation of the
field correction or recall. Both parties will test retained samples
of lots in question and report its findings to the other within ten
(10) working days. Each party retains the right to correct field
problems arising
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out of its fault or omission as it deems appropriate, with or without
the concurrence of the other. All information about Product complaints
shall be considered "Confidential Information" under the terms of the
Agreement.
(b) 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. 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.
(c) 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 such complaints have been confirmed by
MENTOR QA/QC or technical service personnel using the same standards for
confirmation which MENTOR's uses for products other than the PERIMMUNE
Product and which are believe 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, using the same
standards for evaluation and investigation that PERIMMUNE uses for
products other than the Product. 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.
(d) 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 materially adverse impact on
performance of the Product.
(e) Recalls or field notifications with respect to the Product, or any of
them, shall be the responsibility of the party whose fault or omission
necessitated such action, as described in Article 10(c).
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(f) Should there be a difference of opinion between PERIMMUNE and
MENTOR regarding a field notification or recall, MENTOR will
exercise the right to notify its customers without delay.
12. Warranties.
(a) PERIMMUNE warrants that the Product which is or will be the subject
of FDA cleared 510(k) premarket notifications have not been changed
or modified in design, components, method of manufacture or
intended use from the Product as described in those 510(k)
premarket notifications, and will notify MENTOR in advance of any
changes in accordance with Article 1.
(b) PERIMMUNE warrants that the Product manufactured and supplied under
this Agreement shall at the time of shipment meet the Quality
Control Specifications of PERIMMUNE which are attached to this
Agreement as Exhibit B. No claim under this warranty may be made
with respect to a unit of the Product if shipped or used after the
expiration of the shelf-life of the Product as determined by
PERIMMUNE. PERIMMUNE further warrants that prior to shipment to
MENTOR, all of its standard tests and quality control procedures
have been carried out in relation to each lot of the Product with
satisfactory results. The limited warranty to MENTOR set forth in
this Agreement shall control over any warranty provisions which may
be set forth in MENTOR's Product literature and MENTOR shall hold
PERIMMUNE harmless from any and all damages and expenses which
PERIMMUNE may incur as a result of unauthorized MENTOR warranties
or representations. PERIMMUNE MAKES NO WARRANTY EXPRESSED OR
IMPLIED WITH RESPECT TO THE PRODUCTS BEYOND THAT WHICH IS SET FORTH
IN THIS AGREEMENT INCLUDING THE WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR ANY PARTICULAR PURPOSE. Any warranty made by MENTOR to
its customers with respect to the Product shall not obligate
PERIMMUNE in any way.
(c) Upon its verification of any claim of defect or nonconformity of
any unit of the Product arising out of a fault or omission
attributable to PERIMMUNE, during the term of this Agreement,
PERIMMUNE will provide MENTOR with a replacement unit to the extent
necessary to honor PERIMMUNE's warranties contained in Section
12(a) hereof, or make good any shortages or non-completed
deliveries and shall pay all associated freight and insurance
associated therewith.
(d) PERIMMUNE's liability under any legal or equitable theory to any
person with respect to the Product and/or the relationship
described in this Agreement shall be limited to the replacement of
the unit, or if impractical, return of the purchase price paid by
MENTOR for such unit. PERIMMUNE shall in no event be liable to
MENTOR or any other person for any incidental or consequential
damages, lost
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profits, cost procurement of substitute goods or any indirect,
special, or consequential damages even if PERIMMUNE has been
informed of the possibility thereof.
(e) As of the date hereof, PERIMMUNE warrants that it has no knowledge
that the manufacture, use or sale of all or any of the Product under
this Agreement, nor any method of using such Product infringes on
any patent or other industrial property right of a third party, and
PERIMMUNE has not received any notification from any third party
alleging that the manufacture, use or sale of any such Product does
or would infringe any patent or other industrial property. PERIMMUNE
shall further disclose all information relating to the art of the
Product of which it is, or becomes, aware relating to intellectual
property, when PERIMMUNE recognizes necessary to do so.
13. Packaging and Intellectual Property. MENTOR shall be responsible for
packaging and labeling the Product. 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,
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 propriety rights, MENTOR shall, at
PERIMMUNE's sole expense, render reasonable assistance to PERIMMUNE in
defending such claims.
14. Compliance with other Agreements. Each party represents and warrants
that the execution and delivery by it of this Agreement and the
performance by it of its obligations hereunder will not, with or without
the giving of notice or the passage of time, violate any judgement,
writ, injunction or order of any court, arbitration or governmental
agency or conflict with, result in the breach of any provisions of, or
the termination of, or constitute a default under, any agreement to
which PERIMMUNE or MENTOR is a party or by which it is or may be bound.
15. Indemnity.
(a) Except as limited by the remainder of this paragraph, PERIMMUNE
hereby agrees to indemnify MENTOR against claims of third parties
for injuries to their persons arising from the use of Product
supplied by PERIMMUNE to MENTOR hereunder. This indemnity shall not
apply to, and PERIMMUNE shall not be liable for, claims for injuries
caused by or arising from:
1) any act or failure to act on the part of MENTOR, its employees,
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representatives, agents, or subsidiaries in packaging,
handling, storing or otherwise distributing such Product; or
2) any representation or warranty concerning the Product made by
or on behalf of MENTOR and not specifically authorized by
PERIMMUNE; or
3) claims where the use of the Product by any customer was not in
accordance with the use prescribed by PERIMMUNE; or
4) MENTOR'S failure to disseminate to purchasers or end-users
any Product Information which PERIMMUNE has made available to
MENTOR; or
5) claims where PERIMMUNE has not been notified in writing within
forty five (45) days of MENTOR's first notice of the claim; or
6) claims where MENTOR fails to furnish evidence in its
possession or fails to fully cooperate with PERIMMUNE in
preparing the defense; or
7) claims where PERIMMUNE is not given the option to assume the
sole defense of the claim at PERIMMUNE's expense; or
(b) PERIMMUNE shall indemnify MENTOR from any claims of patent
infringement relating to a Product subject to this Agreement
provided MENTOR gives PERIMMUNE notice within forty-five (45) days
of MENTOR's first notice of the claim, and permits PERIMMUNE to
assume the sole defense of the claim at PERIMMUNE's expense;
provided, however, that the claim is not based upon (i) the sale or
use of any Product in combination with any other product which is
not specifically authorized by PERIMMUNE in writing; (ii) the
application of any Product in any manner not specifically
authorized by PERIMMUNE in writing.
(c) MENTOR shall indemnify and hold PERIMMUNE harmless from and against
any third party action brought against PERIMMUNE and any loss
therefrom arising or related to this Agreement, except as may be
caused by the negligent or willful act of PERIMMUNE.
(d) Notwithstanding anything above to the contrary, in the event of a
third party claim arising out of this Agreement, in which neither
PERIMMUNE or MENTOR is in breach of this Agreement or is
negligent, each party shall pay its respective legal expenses and
damages caused by such claim.
16. Fees. MENTOR acknowledges that it will pay $500,000 (USD) to PERIMMUNE in
connection with this Agreement, unless MENTOR elects to take an equity
position in PERIMMUNE.
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17. Force Majeure. Neither party shall be responsible for any failure to
perform due to causes beyond its control. These causes shall include, but
not be limited to, fire, storm, flood, earthquake, explosion, wars,
riots, civil disorder, sabotage, quarantine restrictions, labor disputes,
labor shortages, transportation embargoes, or failure or delays or
disruption in manufacturing process, curtailment of or failure in
obtaining fuel or electrical power, or the acts of any governmental
authority, or instrumentalities, orders of any court or tribunal whether
foreign or domestic, exchange restrictions, acts of God, acts of the
Federal Government or any agency thereof, acts of any state or local
government or agency thereof, or shortage of materials or any similar or
dissimilar occurrence beyond the reasonable control of the party which is
prevented, interrupted or delayed in the performance of its obligations
hereunder. In no event shall PERIMMUNE be under any obligations to
purchase Products or similar products from any third party in order to
supply same to MENTOR hereunder. Any force majeure event shall not excuse
performance by the party but shall delay performance, unless such force
majeure continues for a period in excess of ninety (90) days. In such
event, the party seeking performance, as its sole and exclusive remedy,
may cancel its obligations under this Agreement.
18. Insurance. Each party shall keep in force during the term of this
Agreement 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.
19. Confidentiality.
(a) 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 date which:
(1) is disclosed by one party hereto to the other;
(2) is claimed by the disclosing party to be secret, confidential
and proprietary to the disclosing party; and
(3) 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.
(b) Non-Disclosure. During the period that this Agreement remains in
effect and for a period of three (3) years following termination
thereof, each party (except as is explicitly otherwise required
hereby) shall keep confidential, shall not use for itself
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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:
(1) is known to the recipient thereof, as evidenced by said
recipient's written records, prior to receipt thereof from the
other party hereto;
(2) 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;
(3) is or becomes a part of the public domain through no fault of
the said recipient; or
(4) is required by law or judicial or administrative process to be
disclosed.
(c) PERIMMUNE and MENTOR shall agree to keep confidential and not
disclose to third parties, the supply and working relationship under
this Agreement.
(d) 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.
20. 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-distributor's 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-distributors 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.
21. Successors. This agreement shall be binding upon the successors of
PERIMMUNE and MENTOR, including successors who acquire the business assets
of PERIMMUNE and MENTOR. In the event the Principal(s) of PERIMMUNE shall
sell all or a majority of the outstanding stock of PERIMMUNE, or in the
event PERIMMUNE sells the business relating to the manufacture and sale
for the Product, then the term of this Agreement may be extended
unilaterally by MENTOR for three (3) successive terms of one (1) year each
from the date of the transfer of the control of PERIMMUNE, or sale of the
Product business, or the date for termination under the Agreement,
whichever is the later, upon the
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terms of this Agreement. MENTOR shall give PERIMMUNE written notice of its
intent to extend the term of this Agreement within thirty (30) days after
PERIMMUNE advises MENTOR of the sale of PERIMMUNE's Product business and at
least ninety (90) days before the end of each one (1) year term.
22. Resolution of Disputes. In the event of any controversy or claim arising
under or in relation to this Agreement, including any issue about payment
of amounts due, the parties shall, in good faith, attempt to resolve the
controversy or claim by negotiation. If the controversy or claim cannot be
resolved within sixty (60) days, then either party shall be entitled to
initiate litigation to resolve the dispute unless the parties have
mutually agreed to arbitrate the dispute.
23. Notices. Any notice or other communication required or that shall be
given pursuant to this Agreement shall be deemed sufficient if delivered
personally, sent by facsimile, telegraph, or sent by certified, registered
or express mail, postage prepaid to the address or facsimile number set
forth below:
To PERIMMUNE:
PERIMMUNE, INC.
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Facsimile No: 301/840-2161
ATTN: President and CEO
MENTOR CORPORATION
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile No: 805/967-3362
ATTN: Chairman of the Board, CEO
Either party may change the address to which notice to it is to be given,
as provided herein.
24. Entire Agreement. This Agreement and the exhibits referred to herein
constitute the entire Agreement between the parties and supersede all
prior proposals, communications, representations and agreements, whether
written or oral, with respect to the subject matter hereof. No change to
the written terms of this Agreement shall be made except by written
instrumentation executed by the parties hereto.
25. No Waiver. The failure of either party to enforce at any time any of the
provisions of this Agreement shall not be construed to be a waiver of
those provisions or of the right of that party thereafter to enforce those
provisions.
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26. Severability. If any provision of this Agreement is or becomes or is
deemed invalid, illegal or unenforceable in any jurisdiction in which the
Agreement is sought to be enforced, (a) such provision shall be deemed and
amended to conform to applicable laws of such jurisdiction so as to be
valid and enforceable or, if it cannot be so amended without materially
altering the intention of the parties, it shall be stricken; (b) the
validity, legality and enforceability of such provision will not in any
way be affected or impaired thereby in any other jurisdiction; and (c) the
remainder of this Agreement shall remain in full force and effect.
27. Headings. The headings of this Agreement are included only for ease of
reference and shall not affect the interpretation of this Agreement in any
manner.
28. THIS AGREEMENT CONTAINS A BINDING ARBITRATION PROVISION ENFORCEABLE BY
EITHER PARTY.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized officers or authorized representatives.
PERIMMUNE, INC.
By: /s/ [SIG]
------------------------
Title: President & CEO
------------------------
Date: 6/16/97
------------------------
MENTOR CORPORATION
By: /s/ [SIG]
------------------------
Title: Chief Executive Officer
------------------------
Date: June 13, 1997
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