MGH/wmh:6/5/97
PerImmune.wp6
MGH/wmh:6/5/97
PerImmune.wp6
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 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" shaD
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 hereinafter 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,
(a) failure of 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
va]id 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
alterative 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.
(b) submit its purchase orders to PERIMMUNE in writing or
via facsimile, signed by an authorized representative
of MENTOR.
(c) pay an 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 shaD 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 resuming any of
the Product.
(f) maintain a properly framed 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 an 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 represent itself
as agent or partner of PERIMMUNE.
(m) comply with all laws and regulations and requirements
applicable to a seller of invitro 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 shelflife 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 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.
(i) 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, 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 Products
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 PER~E 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 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 PER~ 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, PER~E
agrees to provide MENTOR with a written interim or
final complaint investigation report, using the same
standards for evaluation and investigation that P~ 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 PER~ 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).
(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
WARRANTIES 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 profits, cost of
procurement of substitute goods or any indirect,
special, or consequential damages even if PER~E 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
shaD, at PERIMMUNE's sole expense, render reasonable
assistance to PER~ 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, 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 on (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) Not withstanding 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 claims
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.
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 PER~E 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 data 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 or for the
benefit of others and shall not copy or allow to be
copied in whole or in part any Confidential ~formation
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
~formation to employees and agents having a need to
know and to protect Confidential ~formation 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 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.
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 duty authorized officers or authorized
representatives.
PERIMMUNE, INC.
By: /s/▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
Title: President
Date: June 13, 1997
MENTOR CORPORATION
By: /s/▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
Title: Chairman, CEO
Date: June 13, 1997
