1
EXHIBIT 10.6
DEVELOPMENT AND SUPPLY AGREEMENT
This DEVELOPMENT AND SUPPLY AGREEMENT ("Agreement") effective as of
April 19, 1995 (the "Effective Date") by and between Urosurge Inc., a Delaware
corporation, with offices at Technology Innovation Center, Suite 104, University
of Iowa, Xxxx Xxxx, Xxxx 00000-0000, ("Urosurge"), and Interventional
Therapeutics Corporation, a California corporation, with offices at 00000
Xxxxxxx Xxxxx, Xxxxxxx, Xxxxxxxxxx, 00000 ("ITC").
BACKGROUND
A. Urosurge and ITC desire that ITC perform development work on
behalf of Urosurge with respect to Products (as defined herein), on the terms
and conditions set forth herein.
B. ITC desires to manufacture and sell Products (as defined herein)
exclusively for and to Urosurge, and Urosurge is willing to purchase its
requirements Products from ITC in the United States, on the terms, and
conditions herein.
C. Urosurge and ITC have entered into a Regulatory Affairs and
Indemnity Agreement of even date herewith (the "Regulatory Affairs Agreement").
NOW, THEREFORE, Urosurge and ITC agree as follows:
1. DEFINITIONS
The following terms shall have the following meanings herein:
1.1 "FDA" shall mean the U.S. Food and Drug Administration.
1.2 "GMP" shall mean Good Manufacturing Practices as established by
FDA regulations.
1.3 "Intellectual Property Rights" shall mean all current and future
worldwide patents and other patent rights, copyrights, trade secrets, and all
other intellectual property rights, including without limitation all
applications and registrations with respect thereto.
1.4 "Products" shall mean the products to be developed by ITC as set
forth in Exhibit A and supplied to Urosurge hereunder.
1.5 "Specifications" shall mean the technical and other
specifications for the Products as set forth on Exhibit A.
2
1.6 "Technology" shall mean all tangible and intangible results
created in the performance of any Product development, including the Products
and all Intellectual Property Rights embodied in the Products.
2. PRODUCT DEVELOPMENT AND PROTOTYPES
2.1 Development. If Urosurge requests modifications to the Product,
ITC agrees to develop the modified Products in accordance with specifications,
schedules and acceptance procedures to be mutually agreed upon. ITC shall not
subcontract any aspect of such development work without Urosurge's prior written
consent. ITC shall be responsible for all costs associated with such development
work related to the Product described in Exhibit A. If Urosurge requests
extensive revisions to the specifications on Exhibit A or requests future
product development the parties shall negotiate in good faith the terms on which
such development work shall be conducted.
2.2 Supply of Prototypes. ITC shall deliver a prototype Product to
Urosurge. Following the acceptance by Urosurge of the prototype, ITC shall
provide Urosurge with 300 Products suitable for use in clinical trials at the
prices indicated in Exhibit B.
2.3 Ownership.
(a) Each party shall retain ownership of all Intellectual Property
Rights owned by it as of the Effective Date. ITC shall own all right, title, and
interest in the Technology.
(b) ITC agrees, during the term of this Agreement, not to use any
equipment and tooling purchased by it to enable the manufacture of Products for
any purpose other than to fulfill its supply obligations to Urosurge hereunder.
3. PRODUCT MANUFACTURE AND SALE
3.1 Purchase and Sale. Subject to the terms and conditions of this
Agreement, ITC agrees to manufacture and sell to Urosurge all Products ordered
by Urosurge during the term of this Agreement. Unless otherwise agreed by the
parties, ITC shall sell the Products exclusively to Urosurge.
3.2 Exclusive Supplier. During the term of this Agreement, ITC shall
be the exclusive supplier of Products to Urosurge for sale in the U.S. ITC shall
be the exclusive supplier outside the U.S., as soon as practicable, provided ITC
demonstrates to Urosurge that the Product is available outside the U.S. and that
the Product is free from U.S. FDA limitations on distribution. Urosurge shall be
solely responsible for regulatory clearances deemed necessary by
-2-
3
individual foreign countries or regulatory bodies. ITC shall use its best
efforts to provide technical information and physical test date as requested by
Urosurge in support of such efforts. ITC shall ensure that U.S. and foreign
manufacturing facilities conform to European Community (EC) and ISO standards
requirements when necessary. Notwithstanding the foregoing, if ITC is unable to
supply Urosurge's requirements for Products, Urosurge shall have the right to
purchase the Products or any components from any other source without obligation
to ITC. In that event, ITC shall license the other source to manufacture the
Products at a reasonable customary royalty rate.
3.3 Orders. Urosurge may initiate purchases under this Agreement by
telephone contact, telex, fax or by submitting written purchase orders to ITC at
the address above. Any purchase order initiated by telephone, fax or telex order
must be confirmed within ten (10) working days by a written purchase order. All
purchase orders shall contain: (a) purchase order number and date; (b) Product
model number; (c) specification number and revision level; (d) part number and
revision level; (e) quantity of Product(s) to be purchased; (f) shipping
instructions; (g) specified delivery date; (h) destination and billing address
(if different from address listed above); (i) the net unit price for the
Product(s); and (j) an authorized signature.
3.4 Acceptance. Purchase orders shall be binding when accepted by
ITC. ITC shall acknowledge each purchase order in writing within ten (10)
business days of receipt. Within such ten (10) day period, ITC may only reject
an order which does not conform with the terms and conditions of this Agreement.
Notice of rejection must be sent to Urosurge by telex or fax, followed by
registered letter. If an order is neither confirmed nor rejected by ITC within
ten (10) business days of receipt, it shall be deemed to have been accepted.
3.5 Delivery Date. Unless otherwise agreed in writing by the parties,
ITC shall deliver Products no later than five (5) days after the date specified
in an accepted purchase order, provided ITC receives such purchase order at
least ninety (90) days prior to the specified delivery date. If ITC receives a
purchase order less than ninety (90) days before the specified delivery date,
ITC shall use reasonable commercial efforts to deliver such Products on the
specified delivery date.
3.6 Shipping. All Products subject to this Agreement shall be
suitably packed for shipment in containers adequate to insure safe arrival of
the goods at Urosurge's designated delivery destination, marked for shipment to
the address specified in Urosurge's purchase order or such other address as
Urosurge may specify in writing, and delivered to a carrier or forwarding agent
chosen by Urosurge. ITC shall xxxx all containers with necessary lifting,
handling and shipping information, purchase order numbers, and date of shipment.
An itemized packing list must accompany each shipment. Urosurge will reimburse
ITC for all transportation, shipping and insurance expenses. In the event that
Urosurge requests special packaging or
-3-
4
finishing for any order, Urosurge shall pay the incremental cost for such
special packaging or finishing; provided, however, ITC agrees to pack any
special documentation regarding the Products requested by Urosurge, at no
additional charge. Shipment will be F.O.B., ITC's plant, Fremont, California.
All shipping papers and/or invoices shall include the purchase order number and
serial numbers of Products shipped.
3.7 Terms and Conditions. This Agreement contains the exclusive terms
and conditions which shall apply to all purchases of Products by Urosurge. In
ordering and delivering Products, Urosurge and ITC may use their standard forms
but nothing in such forms shall amend or modify the terms of this Agreement. In
case of conflict between such forms and this Agreement, the terms of this
Agreement shall control.
4. CANCELLATION AND RESCHEDULING
4.1 Changes. Urosurge may cancel or reschedule for up to thirty (30)
days a purchase order previously accepted by ITC, provided Urosurge provides ITC
notice at least sixty (60) days prior to the specified delivery date. ITC will
use reasonable commercial efforts to meet all rescheduled delivery dates.
Cancellation or rescheduling requests made by Urosurge less than sixty (60) days
prior to the specified delivery date may be accepted or rejected at ITC's
discretion.
4.2 Delayed Delivery. ITC shall promptly notify Urosurge if any
circumstance arises which could result in delivery of a Product after the
specified delivery date in an accepted purchase order. If Urosurge has not
received Products for which ITC accepted a purchase order more than twenty (20)
days following the specified delivery date, Urosurge shall be entitled to cancel
such order, in whole or part, without any obligation or liability to ITC.
5. PRICING
5.1 Product Prices. Except as otherwise provided in this Section 51,
the price for Products subject to this Agreement shall be those listed on
attached Exhibit B. All prices are in United States dollars. The prices as set
forth on said Exhibit shall remain in effect and fixed during the term of this
Agreement. If during the term of this Agreement reduced prices are put into
effect by ITC, such reduced prices shall apply to released but unshipped
Products and all subsequent release orders issued hereunder. ITC warrants that
the prices charged Urosurge hereunder are not in excess of the lowest prices
charged by ITC to other purchasers of the similar Products in like quantities
and under similar circumstances.
5.2 Taxes. All prices described herein are exclusive of federal,
state and local excise, sales, use and similar taxes. Urosurge shall be liable
for and shall pay all applicable
-4-
5
taxes invoiced by ITC, unless Urosurge provides ITC with a properly executed tax
exemption certificate prior to delivery.
6. PAYMENT
6.1 Payment. ITC shall issue Urosurge individual invoices for each
Product shipment. Each such invoice shall separately list the price of each
Product, taxes, transportation, shipping and insurance charges, and any special
packaging or finishing charges. Urosurge shall pay each invoice within thirty
(30) days of the date of such invoice or the delivery date, whichever is later.
Payment of an invoice shall not constitute implied acceptance of Products.
6.2 Payment Method. Urosurge shall make payment to ITC for Products
by check or by wire transfer to an account specified by ITC.
6.3 Overdue Payments. Payments more than thirty (30) days overdue
will be subject to a service charge of one percent (1%) per month or the
maximum amount allowed by law, whichever is less.
7. FORECASTS
On a quarterly basis thereafter Urosurge shall provide ITC with a
forecast of Urosurge's anticipated quarterly requirements of Products for the
following twelve (12) month period commencing on the date of such forecast. It
is understood that such forecast is not binding but Urosurge shall use all
reasonable efforts to make each forecast as accurate as possible, particularly
as it pertains to the six (6) months immediately following the date of such
forecast.
8. PRODUCT QUALITY
8.1 Quality Assurance. ITC agrees to assure the quality level of
Products through the use of a formal quality assurance program reasonably
acceptable to Urosurge. Such program shall require ITC to prepare and maintain
written records sufficient to enable Urosurge to trace the history of each
Product. Pursuant to such program, ITC shall place serial numbers on all
Products to enable the identification and tracing of Products. During the term
of the Agreement, Urosurge shall have the right to audit such quality assurance
program, at its expense, during regular business hours.
8.2 Inspection. ITC shall conduct a final inspection and quality
control test on each Product prior to shipment to verify that such Products meet
and conform with the Specifications.
-5-
6
Each shipment of Products shall be accompanied by a quality assurance analytical
data sheet (the "Q.A. Data Sheet").
8.3 Presence at Facility. During the first six (6) months during
which each Product is commercially manufactured for Urosurge and thereafter upon
reasonable written notice to ITC, Urosurge shall have the right to have its
representatives visit, from time to time, the facility at which such Product is
being manufactured, to verify ITC's compliance with the warranties in Section 10
below.
8.4 Inspection and Acceptance. Urosurge shall have the right and ITC
shall cooperate to the fullest extent practicable in giving Urosurge an
opportunity to inspect the Products at all times and places including during the
period of manufacture. However, no inspection or test made prior to final
inspection and acceptance at Urosurge's facility shall relieve ITC of
responsibility for defects or other failure to supply conforming Products. Final
inspection and acceptance shall be at Urosurge's facility, and shall be
performed within a reasonable time after receipt of the Products.
8.5 Latent Defects. It is understood that Products may have defects
("defects" meaning that such Products fail to conform to the applicable
Specifications or otherwise fail to conform to the warranties given by ITC
herein) which would not be discoverable upon reasonable physical inspection or
testing (the "Latent Defects"). As soon as either Urosurge or ITC becomes aware
of a Latent Defect in any Product it shall immediately notify the other party
and, at Urosurge's election, such Products shall be deemed non-conforming to the
Specifications and rejected as of the date of such notice.
9. PRODUCT CHANGES
9.1 Design Modifications. ITC shall have the right to make design
modifications to the Products to the extent such modifications do not affect the
form, fit, function, safety, reliability, or performance of a Product; provided,
however, that ITC shall notify Urosurge of any such modifications that
materially affect the form, fit, function, safety, reliability, or performance
of the Products. Within twenty (20) days after receiving any such notice from
ITC, Urosurge may disapprove of such design modifications. If Urosurge fails to
provide ITC with notice during such twenty (20) day period, Urosurge shall be
deemed to approve such modifications.
9.2 Requested Modifications. Urosurge may request changes in the
design or operation of the Products relating to improvements, or the reliability
or serviceability of the Products. The parties shall discuss such modifications
in good faith; provided, however, it is understood that ITC shall have no
obligation to make such modifications to the Products.
-6-
7
9.3 Mandatory Modifications. ITC shall make any changes to Products
required to comply with official requirements (including governmental regulation
or industrial standards). With respect to products changed to comply with such
requirements that have been ordered but not yet delivered, an appropriate
adjustment of the delivery date shall be agreed by the parties.
9.4 Validation Units. In the event ITC proposes any change which
affecting form, fit, function, safety, reliability or performance of a Product,
ITC, at its expense, shall ship Urosurge ten (10) validation units incorporating
all such changes. Within ninety (90) days after receipt of such validation unit,
Urosurge shall notify ITC whether it approves or disapproves the proposed
changes. Failure by Urosurge to advise ITC that it disapproves a proposed change
within such ninety (90) days shall constitute Urosurge approval of such proposed
changes; provided, however, ITC shall not make the proposed changes until the
end of such ninety (90) day period or until Urosurge provides notice of its
approval of such changes, whichever occurs earlier.
10. PRODUCT WARRANTY
10.1 Express Warranty. ITC hereby warrants to Urosurge that:
(a) on the date of shipment, all Products sold by ITC to
Urosurge hereunder are new, will comply with the Specifications for such
Products and any further specifications, standards and/or criteria agreed upon
by the parties, conform fully with the Q.A. Data Sheet provided for the
particular Product according to Section 8.2 hereof, and do not contain Latent
Defects;
(b) Products purchased hereunder shall be free from defects in
material and workmanship for a period of twelve (12) months from the date of
shipment to Urosurge;
(c) all of the Products sold hereunder shall have been
manufactured, packaged and stored and shipped in conformance with all applicable
current Good Manufacturing Practices which are in force or hereinafter adopted
by the FDA or any successor agency thereto;
(d) title to all Products sold hereunder shall pass to Urosurge
as provided herein free and clear of any security interest, lien, or other
encumbrance;
(e) ITC shall meet Urosurge's required shipment and/or delivery
schedule(s); and
-7-
8
(f) the Products sold hereunder shall have been manufactured,
packaged and stored in facilities which are approved by the FDA at the time of
such manufacture, packaging and storage, to the extent such approval is required
by law.
10.2 Effect of Warranty.
(a) If any Products purchased hereunder do not meet the
warranties specified herein or otherwise applicable, Urosurge may, at its option
(i) require ITC to replace or correct at no cost to Urosurge any defective or
nonconforming Products, (ii) return any nonconforming Products to ITC at ITC's
expense and recover from ITC the full market price thereof or (iii) replace or
correct the defective or nonconforming Products itself and charge ITC with the
cost of such correction. In the event that ITC fails to meet Urosurge's shipment
and/or delivery schedules Urosurge may, at its option, (i) procure equivalent or
similar replacement Products in a commercially reasonable manner from an
alternate source, charging ITC for the price differential, if any, or (ii) if an
alternate source is not available, recover from ITC all financial losses of any
nature resulting therefrom. The foregoing remedies are in addition to all other
remedies at law or in equity or under this Agreement and shall not be deemed to
be exclusive thereof. All warranties and remedies for breach thereof available
to Urosurge under this Agreement shall also be available to Urosurge's
customers.
(b) No inspection or acceptance, approval or acquiescence by
Urosurge with respect to ITC's Products shall relieve ITC from any portion of
its warranty obligation, nor shall waiver by Urosurge of any specification
requirement for one or more items constitute a waiver of such requirements for
remaining items unless expressly agreed by Urosurge in writing.
10.3 Exclusions. The express warranties set forth in Section 10.1
above shall not apply to defects to a Product which result from normal wear and
tear or improper, unqualified or unauthorized repair of Products.
10.4 Disclaimer. EXCEPT FOR THE ABOVE EXPRESS WARRANTIES, ITC MAKES
NO WARRANTIES WITH RESPECT TO THE PRODUCTS, EXPRESS, IMPLIED, STATUTORY, OR IN
ANY OTHER PROVISION OF THIS AGREEMENT, AND ITC SPECIFICALLY DISCLAIMS ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
10.5 Warranty Procedures. Subject to Section 10.2 above, Urosurge may
send Products with defects covered by the foregoing warranties to ITC's repair
center at an address specified by ITC from time to time. Urosurge shall request
authorization from ITC prior to the return of each defective Product for
replacement by ITC. Upon such request, ITC shall provide Urosurge with a
Material Return Authorization (MRA) tracer number to be prominently
-8-
9
displayed on the shipping container for the defective Product. Once ITC
authorizes the return of any defective Product, Urosurge shall ship such Product
to the repair facility, freight prepaid, in its original shipping container or
in a container of equivalent protective constitution. If such defective Product
is received by ITC during the applicable warranty period, ITC shall, and shall
ship the replaced Product to Urosurge, freight prepaid.
11. CONFIDENTIALITY
11.1 Confidential Information. Pursuant to this Agreement, each party
may disclose to the other certain proprietary technical or business information
or materials ("Confidential Information"). Each party agrees that it will not
use any Confidential Information received from the other except for the purposes
of this Agreement and agrees not to disclose any such Confidential Information
to third parties, and to maintain and follow reasonable procedures to prevent
unauthorized disclosure or use of the Confidential Information and to prevent it
from falling into the public domain or the possession of unauthorized persons.
Each party agrees to disclose to its employees only such Confidential
Information as is necessary to each employee's responsibilities in performing
the acts allowed by this Agreement. Each party shall immediately advise the
disclosing party of any disclosure, loss or use. of Confidential Information in
violation of this Agreement. Each party agrees that for a period of five (5)
years after the termination of this Agreement it will hold the Confidential
Information disclosed to it hereunder in strict confidence and not disclose to
any third party any such Confidential Information except as expressly agreed
upon in writing.
11.2 Exclusions. Confidential Information shall not include
information:
(a) that becomes lawfully known or available to the receiving
party from a source other than the disclosing party without breach of this
Agreement;
(b) that was already known to the receiving party, as shown by
written records, before its disclosure by the disclosing party;
(c) developed independently by the receiving party without the
use or consideration of or reference to the Confidential Information;
(d) that is within, or later falls within, the public domain
without breach of this Agreement;
(e) publicly disclosed with the written approval of the
disclosing party; or
-9-
10
(f) disclosed pursuant to the requirement or demand of a lawful
governmental or judicial authority, but only to the extent required by operation
of law, regulation or court order.
12. REPRESENTATIONS AND WARRANTIES
12.1 Urosurge. Urosurge represents and warrants on a continuing basis
that: (i) it has the right to enter this Agreement, is a corporation duly
organized, validly existing, and in good standing under the laws of Delaware,
(ii) has the power and authority to execute and deliver this Agreement and to
perform its obligations hereunder, (iii) has by all necessary corporate action
duly and validly authorized the execution and delivery of this Agreement and the
performance of its obligations hereunder, and (iv) has not and will not during
the term of this Agreement enter into any agreement which conflicts with or
which will result in any breach of, or constitute a default under, any note,
security agreement, commitment, contract or other agreement, instrument or
undertaking to which Urosurge is a party.
12.2 ITC. ITC represents and warrants on a continuing basis that: (i)
ITC has the right to enter this Agreement, is a corporation duly organized,
validly existing and in good standing under the laws of the State of California,
(ii) has the power and authority, to execute and deliver this Agreement and to
perform its obligations hereunder, (iii) it has by all necessary corporate
action duly and validly authorized the execution and delivery of this Agreement
and the performance of its obligations hereunder, and (iv) it has not and will
not during the term of this Agreement enter into any agreement which conflicts
with or which will result in any breach of, or constitute a default under, any
note, security agreement, commitment, contract or other agreement, instrument or
undertaking to which ITC is a party.
12.3 Effect of Representations and Warranties. It is understood that
if the representations and warranties under this Section 12 are not true and
accurate at any time during the term of the Agreement and the nonbreaching party
(i.e., ITC or Urosurge, as the case may be) incurs any liabilities, costs or
other expenses as a result of such falsity, the breaching party shall indemnify
and hold harmless the other party and its affiliates for any such liabilities,
costs or expenses incurred, in accordance with Section 6 of the Regulatory
Affairs Agreement.
13. TERM AND TERMINATION
13.1 Term. This Agreement shall commence on the Effective Date and
shall have a term of five (5) years unless terminated earlier as provided
herein; provided, however, if Urosurge does not receive FDA approval for the
sale of the Product within four (4) years of the Effective Date of the
Agreement, the Agreement shall automatically be extended for one additional two
(2) year period.
-10-
11
13.2 Termination for Cause. Either party may, without penalty,
terminate this Agreement or cancel any purchase order or portion thereof
effective upon written notice to the other party in the event of one of the
following events:
(a) The other party materially breaches this Agreement or the
Regulatory Affairs Agreement, including, without limitation, by failing to
deliver conforming Products on the requested delivery dates set forth on
Urosurge's purchase orders, and such breach remains uncured for thirty (30) days
following written notice of breach by the nonbreaching party, unless such breach
is incurable in which event termination shall be immediate upon receipt of
written notice;
(b) Any cause as set forth in Section 15.6 delays the other
party's performance for more than sixty (60) days; or
(c) A petition for relief under any bankruptcy statute is filed
by or against the other party, or the other party makes an assignment for the
benefit of creditors, or a receiver is appointed for all or a substantial part
of the other party's assets, and such petition, assignment or appointment is not
dismissed or vacated within sixty (60) days.
13.3 Effect of Termination or Expiration.
(a) In the event of a termination or expiration of this
Agreement the provisions of this Agreement shall continue to apply to all
purchase orders accepted by ITC prior to the effective date of such termination
or expiration. Termination or expiration of this Agreement shall not relieve or
release either party from making payments which obligation has accrued prior to
such termination.
(b) In the event of the default by ITC, Urosurge may take any
reasonable steps which Urosurge deems appropriate and which are authorized by
law or this Agreement to obtain the benefit of its bargain pursuant to this
Agreement in addition to or in lieu of the termination procedure set forth in
this Paragraph.
13.4 Survival. Sections 10, 11, 12, 13, 14 and 15 shall survive the
termination of this Agreement for any reason.
14. DISPUTE RESOLUTION
If a dispute arises between the parties relating to the
interpretation or performances of this Agreement or the grounds for the
termination thereof, representatives of the parties with decision-making
authority shall meet to attempt in good faith to negotiate a resolution of the
-11-
12
dispute prior to pursuing other available remedies. If within thirty (30) days
after such meeting the parties have not succeeded in negotiating a resolution of
the dispute, such dispute shall be submitted to final and binding arbitration
under the then current Commercial Arbitration Rules of the American Arbitration
Association ("AAA"), by one (1) arbitrator in Iowa City, Iowa. Such arbitrator
shall be selected by the mutual agreement of the parties or, failing such
agreement, shall be selected according to the aforesaid AAA rules. The
arbitrator will be instructed to prepare and deliver a written, reasoned opinion
stating his decision within thirty (30) days of the completion of the
arbitration. Such arbitration shall be concluded within nine (9) months
following the filing of the initial request for arbitration. The parties shall
bear the costs of arbitration equally and shall bear their own expenses,
including professional fees. The decision of the arbitrator shall be final and
non-appealable and may be enforced in any court of competent jurisdiction.
15. MISCELLANEOUS
15.1 Governing Law . This Agreement shall be governed by the laws of
Iowa, without reference to principles of conflicts of laws.
15.2 Compliance with Laws. ITC shall perform this Agreement in
compliance with all applicable federal, state and local laws, rules and
regulations. ITC shall indemnify Urosurge and its customers for loss or damage
sustained because of ITC's noncompliance with any such law, rule or regulation.
ITC shall furnish to Urosurge any information requested or required by Urosurge
during the term of this Agreement or any extensions hereof to enable Urosurge to
comply with the requirements of any U.S. or foreign federal, state and/or
government agency.
15.3 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE
LIABLE FOR INCIDENTAL, CONSEQUENTIAL, INDIRECT, OR SPECIAL DAMAGES OF THE OTHER
PARTY ARISING OUT OF THIS AGREEMENT, UNDER ANY THEORY OF LIABILITY.
15.4 Urosurge Trademarks. Urosurge, in its sole discretion, may
select the trademarks, trade names and trade dresses to be used in connection
with each Product and all such trademarks, trade names and trade dresses shall
be and become the exclusive property of Urosurge. ITC shall not adopt any
trademark, trade name or trade dress that may be confusingly similar therewith.
ITC shall acquire no interest or rights in and to any trademarks, trade names
and trade dresses selected or used by Urosurge. Urosurge shall have the right to
remove any ITC trademarks incorporated in marked on, or fixed to the Products.
-12-
13
15.5 No Conflicting Obligations. ITC agrees not, to engage in any
work or services on its behalf or for any other party which would conflict with
its obligations under this Agreement.
15.6 Force Majeure. Neither party shall be held responsible for any
delay or failure in performance hereunder caused by strikes, embargoes,
unexpected government requirements, civil or military authorities, acts of God,
or by the public enemy or other causes reasonably beyond such party's control
and without such party's fault or negligence.
15.7 Independent Contractors. ITC shall perform its obligations
hereunder as an independent contractor and shall be solely responsible for its
own financial obligations. Nothing contained herein shall be construed to imply
a joint venture or principal and agent relationship between the parties, and
neither party shall have any right, power or authority to create any obligation,
express or implied, on behalf of the other in connection with the performance
hereunder. ITC will not act as an agent of Urosurge and ITC's employees shall
not be deemed to be employees of Urosurge for the purpose of any employee
benefit program, tax withholding, FICA taxes, unemployment benefits or
otherwise.
15.8 Confidentiality of Agreement. Except as required by law, ITC
shall not disclose the contents or any term of this Agreement to any person or
entity without the prior written consent of Urosurge.
15.9 Further Assurances. At any time or from time to time on and
after the date of this Agreement, ITC shall at the request of Urosurge (i)
deliver to Urosurge such records, data or other documents consistent with the
provisions of this Agreement, and (ii) execute, and deliver or cause to be
delivered, all such assignments, consents, documents or further instruments of
transfer or license, and (iii) take or cause to be taken all such other actions,
as Urosurge may reasonably deem necessary or desirable in order for Urosurge to
obtain the full benefits of this Agreement and the transactions contemplated
hereby.
15.10 Notices. All notices or reports permitted or required under
this Agreement shall be in writing and shall be delivered in person, mailed by
first class mail, postage prepaid, (registered or certified), or sent by
telecopy, to the party to receive the notice at the address set forth at the
beginning of this Agreement or such other address as either party may specify in
writing. All such notices shall be effective upon receipt.
15.11 No Use of Names. Neither party will use the name of the other
in its advertising or promotional materials without the prior written consent of
such other party.
-13-
14
15.12 Assignment. ITC shall not assign this Agreement or any rights
hereunder without the prior written consent of Urosurge. Urosurge may assign
this Agreement without restrictions.
15.13 Severability. If any provision(s) of this Agreement shall be
held invalid, illegal or unenforceable by a court of competent jurisdiction,
this Agreement shall continue in full force and effect without said provision.
15.14 Modification; Waiver. This Agreement may not be altered,
amended or modified in any way except by a writing signed by both parties. The
failure of a party to enforce any provision of the Agreement shall not be
construed to be a waiver of the right of such party to thereafter enforce that
provision or any other provision or right.
15.15 Entire Agreement and Indemnity. This Agreement, the exhibits
hereto and the Regulatory Affairs Agreement represent and constitute the entire
agreement between the parties and supersede all prior agreements and
understandings with respect to the matters covered by this Agreement. This
Agreement may only be amended in writing signed by both parties.
UROSURGE INTERVENTIONAL THERAPEUTICS CORPORATION
By: /s/ XXXXX XXXXXX By: /s/ XXXX XXXXXXXX
---------------------------- ----------------------------
Print Name: XXXXX XXXXXX Print Name: XXXX XXXXXXXX
-------------------- --------------------
Title: PRES/CEO Tide: PRESIDENDT
------------------------- --------------------------
-14-
15
EXHIBIT A
SPECIFICATIONS
[TO BE DETERMINED BY MUTUAL AGREEMENT]
-15-
16
EXHIBIT B
Product Prices
The following prices apply based on the cumulative number of units
ordered annually:
No. of Units Price per Unit
------------ --------------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] Confidential treatment requested.
17
REGULATORY AFFAIRS AND INDEMNITY AGREEMENT
This REGULATORY AFFAIRS AND INDEMNITY AGREEMENT ("Agreement") is
effective as of August 30, 1995 (the "Effective Date") by and between Urosurge
Inc., a Delaware corporation, with offices at 0000 Xxxxxxxxx Xxxx, Xxxxxxxxxx,
Xxxx 00000, ("Urosurge"), and Interventional Therapeutics Corporation, a
California corporation, with offices at 00000 Xxxxxxx Xxxxx, Xxxxxxx,
Xxxxxxxxxx, 00000 ("ITC").
BACKGROUND
A. Urosurge and ITC have entered into an agreement under which ITC
will manufacture and sell products to Urosurge ('Products") on the terms and
conditions of a Development and Supply Agreement of even date herewith (the
"Supply Agreement").
B. Urosurge and ITC wish to set forth their respective obligations
regarding regulatory affairs associated with the Supply Agreement.
NOW, THEREFORE, Urosurge and ITC agree as follows:
1. General Obligations. Each party agrees to conduct its activities
pursuant to the Supply Agreement in accordance with state and federal regulatory
laws as applied to clinical trial protocols, device commercialization and the
protection of patient health, welfare and safety.
2. Notification. Each party agrees to notify the other party in a
timely manner of (A) (i) any adverse event, technical or clinical which may
involve a Product and (ii) any FDA communications or inquiries pertaining to
adverse events or adverse actions by FDA, pertaining to a Product. Urosurge
agrees to monitor the use of the Products in accordance with state and federal
regulatory laws, and in a manner to ensure adequate and timely data collection
in order to identify, quantify and correct any anticipated or unanticipated
adverse events. In the event Urosurge determines a recall is necessary, ITC will
cooperate fully with Urosurge in effecting the recall.
3. Progress Reports. Urosurge agrees to provide timely copies of
United States Food and Drug Administration ("FDA") progress reports concerning
clinical trial protocols involving the Products to ITC at the time such reports
are submitted to the FDA. Urosurge shall provide ITC with any regulatory filings
made with respect to the Products.
4. FDA Inquiries. Each party agrees to notify the other in the event
of any FDA inspection, notification or communication which may involve the
Products. ITC agrees to cooperate with Urosurge in responding to. FDA queries
regarding the Products.
18
9.5 Severability. If any provision(s) of this Agreement shall be held
invalid, illegal or unenforceable by a court of competent jurisdiction, this
Agreement shall continue in full force and effect without said provision.
9.6 Modification, Waiver. This Agreement may not be altered, amended
or modified in any way except by a writing signed by both parties. The failure
of a party to enforce any provision of the Agreement shall not be construed to
be a waiver of the right of such party to thereafter enforce that provision or
any other provision or right.
9.7 Entire Agreement. This Agreement and the Supply Agreement
represent and constitute the entire agreement between the parties with respect
to the subject matter thereof and supersede all prior agreements and
understandings with respect to the matters covered by this Agreement. This
Agreement may only be amended in writing signed by both parties.
Urosurge, Inc. Interventional Therapeutics Corporation
/s/ XXXXX XXXXXX /s/ XXXXX X. XXXX
------------------------------- -------------------------------
BY: BY: Xxxxx X. Xxxx
VP, Regulatory Affairs & Risk
Pres/CEO Management
------------------------------- -------------------------------
TITLE: TITLE:
9/12/95 August 30, 1995
------------------------------- -------------------------------
DATE DATE:
4
