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EXHIBIT 10.48
CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE
BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
SUPPLY, LICENSE AND DISTRIBUTION AGREEMENT
This Supply, License and Distribution Agreement (the "AGREEMENT") is
entered into as of March 27, 2000, between INNERDYNE, INC., a Delaware
corporation with principal offices at 0000 Xxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000
("INNERDYNE"), phone: 408/000-0000, fax: 408/000-0000, and MAXXIM MEDICAL, INC.,
a Delaware corporation, with principal offices at 00000 - 00xx Xxxxxx Xxxxx,
Xxxxxxxxxx, Xxxxxxx 00000 ("MAXXIM"), phone 727/000-0000, fax: 727/000-0000.
RECITALS
WHEREAS, Maxxim is in the business of developing, manufacturing and
marketing interventional cardiology, radiology and neurology medical devices;
and
WHEREAS, InnerDyne is in the business of developing and manufacturing
interventional cardiology, radiology and neurology access devices using radially
expanding dilation technology ("R.E.D. Technology"); and
WHEREAS, InnerDyne has developed certain technologies including radially
expandable/dilatable access devices ("InnerDyne Devices") as part of its R.E.D.
Technology; and
WHEREAS, Maxxim desires to potentially use the InnerDyne Devices with
other components to create a system useful for percutaneous vascular access (the
"System"); and
WHEREAS, Maxxim desires to purchase InnerDyne Devices from InnerDyne;
and
WHEREAS, InnerDyne desires to supply InnerDyne Devices to Maxxim
NOW THEREFORE, in consideration of the mutual promises contained herein,
the parties agree as follows:
1. DEFINITIONS
(a) "EFFECTIVE DATE" shall mean [***] if InnerDyne has received
510(k) approval for Filing No. K992668 for the InnerDyne
Devices discussed herein, and, if not, then the first day of
the month following InnerDyne's receipt of a marketing
clearance with respect to U.S. Food and Drug Administration
510(k) filing No. K992668. Such Effective Date shall be
confirmed in writing by the parties hereto once determined.
(b) "INNERDYNE DEVICES" shall mean those InnerDyne devices
listed in Exhibit "A" attached hereto.
(c) "SYSTEM" shall mean Maxxim's combination of an InnerDyne
Device and a Maxxim Product for use in the Permitted Fields.
(d) "MAXXIM PRODUCTS" shall mean those Maxxim products chosen by
Maxxim, in its sole and absolute discretion, to be sold in
conjunction with the InnerDyne Devices.
[***] Confidential material redacted and filed separately with the Commission.
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Maxxim shall be under no obligation to continue the
production of any Maxxim Product.
(e) "PERMITTED FIELDS" shall mean interventional cardiology,
radiology, neurology and critical care.
(f) "TERRITORY" shall mean the United States and Central and
South America including the East and West Caribbean.
(g) "ADDITIONAL TERRITORY" shall include [***].
(h) "AFFILIATE" shall mean any entity that directly or
indirectly Owns, is Owned by or is under common Ownership
with a Party to this Agreement, where "Own" or "Ownership"
means direct or indirect possession of greater than fifty
percent (50%) of the outstanding voting stock/securities of
a corporation or a comparable equity interest in any other
type of entity.
(i) "CHANGE OF CONTROL" shall mean a merger or acquisition of a
Party, or sale of all or substantially all of a Party's
assets.
(j) "GOVERNMENT APPROVAL" shall mean any approvals, licenses,
registrations or authorizations of any domestic or
international, federal, state or local regulatory agency,
department, bureau or other government entity, necessary for
the use, marketing, sale or distribution of the InnerDyne
Device in the Territory including but not limited to 510(k)
approvals.
(k) "PURCHASE PRICE" shall mean the purchase price to be paid by
Maxxim for the InnerDyne Devices from InnerDyne.
(l) "SPECIFICATIONS" shall mean the specifications for the
InnerDyne Device as provided hereto as Exhibit "A", which
shall include, as an attachment, the FDA 510K Filing No.
K992668, the terms and conditions of which shall be
incorporated into Exhibit A and all of which shall be
included in the Specifications.
2. APPOINTMENT AND AUTHORITY OF MAXXIM
(a) Appointment; License Grant. Subject to the terms and
conditions set forth herein, InnerDyne hereby appoints Maxxim
as InnerDyne's exclusive distributor for, and grants an
exclusive license to Maxxim under its intellectual property
rights to market and sell, the InnerDyne Devices individually
or in combination with Maxxim Products as part of a System
for use in the Permitted Fields throughout the Territory, and
Maxxim hereby accepts such appointment and grant. During the
Term of this Agreement, InnerDyne shall not appoint any other
distributor with responsibility for, or grant any other
license with respect to the marketing and sale of the
InnerDyne Devices in the Territory for use in the Permitted
Fields.
(b) Independent Contractors. The relationship of InnerDyne
and Maxxim established by this Agreement is that of
independent contractors, and nothing contained in this
Agreement shall be construed to create any kind of agency,
joint venture or other type
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of relationship or to give either party the power to direct
and control the day-to-day activities of the other or allow
one party to create or assume any obligation on behalf of
the other for any purpose whatsoever. All financial
obligations associated with Maxxim's business are the sole
responsibility of Maxxim. All financial obligations
associated with InnerDyne's business are the sole
responsibility of InnerDyne. All sales and other agreements
between Maxxim and Maxxim's customers are Maxxim's exclusive
responsibility and shall have no effect on Maxxim's
obligations under this Agreement.
(c) Limited Rights. The rights granted to Maxxim hereunder
are solely marketing and distribution rights with respect to
the InnerDyne Devices, or the combination of InnerDyne
Devices with Maxxim Products as part of a System, for use in
the Permitted Fields throughout the Territory. Maxxim shall
have no rights, express or implied, to make, modify, use or
distribute the InnerDyne Devices other than as expressly
allowed by this Agreement, and InnerDyne expressly retains
all such rights. Maxxim shall retain all rights to the
Systems developed pursuant to this Agreement.
3. TERMS OF PURCHASE OF INNERDYNE DEVICES BY MAXXIM
(a) Terms and Conditions. All purchases of InnerDyne Devices
by Maxxim from InnerDyne during the term of this Agreement
shall be subject to the terms and conditions of this
Agreement.
(b) Prices. All prices of InnerDyne Devices are F.O.B.
InnerDyne's Sunnyvale, California or Salt Lake City, Utah
facility (as determined solely by InnerDyne) or as otherwise
provided by written notice to Maxxim (the "Distribution
Site"). The purchase price to Maxxim for each of the
InnerDyne Devices (the "Purchase Price") shall be as set
forth in Exhibit "A" attached hereto and shall be InnerDyne's
sole remuneration for this Agreement. [***]
(c) Taxes. The Purchase Price does not include any foreign,
federal, state or local taxes that may be applicable to the
InnerDyne Devices. In the event that such taxes are
applicable and InnerDyne has the legal obligations to collect
such taxes, InnerDyne shall be entitled to add to Maxxim's
invoice the amount of such taxes and Maxxim shall pay such
amount unless Maxxim provides InnerDyne with a valid tax
exemption certificate authorized by the appropriate taxing
authority.
(d) Order and Acceptance. All orders for InnerDyne Devices
submitted by Maxxim shall be initiated by written purchase
orders sent to InnerDyne and requesting a delivery date
during the term of this Agreement; provided, however, that an
order may initially be placed orally or by telecopy if a
confirmational written purchase order is received by
InnerDyne within five (5) days after said oral or telecopy
order. To facilitate InnerDyne's production scheduling,
Maxxim shall submit purchase orders to InnerDyne at least
thirty (30) days prior to the first day of the requested
month of
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delivery. InnerDyne shall deliver InnerDyne Devices within 15
days of the times specified in Maxxim's purchase order.
(e) Terms of Purchase Orders. Maxxim's purchase orders submitted
to InnerDyne from time to time with respect to InnerDyne
Devices to be purchased hereunder shall be governed by the
terms of this Agreement. Nothing contained in any purchase
order of Maxxim shall in any way modify the terms of this
agreement or add any additional terms or conditions.
(f) Payment. Full payment of the Purchase Price for the InnerDyne
Devices (including any freight or taxes) shall be in United
States of America dollars. All exchange, interest, banking,
collection, and other charges shall be at Maxxim's expense.
Payment terms shall be net thirty (30) days, and payment shall
be made by check or other instrument approved by InnerDyne. If
Maxxim fails to make any payment to InnerDyne when due,
InnerDyne shall notify Maxxim in writing and provide Maxxim
with fifteen (15) additional days from receipt of such notice
to make payment. In the event that payment is not made within
such period, any invoiced amount not paid following the
fifteen (15) day period described above shall be subject to a
service charge at the lower of the rate of one and one-half
percent (1.5%) per month or the maximum rate permitted by law.
Provided, however, that Maxxim shall be entitled to withhold
payment for any orders which are the subject of a legitimate
dispute for which Maxxim has notified InnerDyne, but only with
respect to products to which the disputed invoice relates.
This in no way relieves Maxxim of its obligations to pay for
such disputed orders or other orders under this agreement.
(g) Shipping. InnerDyne shall be responsible to ensure that all
InnerDyne Devices delivered pursuant to the terms of this
Agreement shall be packaged bulk, non-sterile, suitably packed
for air freight shipment in InnerDyne's standard shipping
cartons, marked for shipment at InnerDyne's manufacturing
plant to Maxxim's address as designated by Maxxim, and
delivered to Maxxim or Maxxim's carrier agent F.O.B.
Distribution Site, at which time title to such InnerDyne
Devices and risk of loss shall pass to Maxxim. In the event
Maxxim does not provide written notice of their carrier agent,
InnerDyne shall select the carrier. All freight, insurance and
other shipping expenses, as well as any special packing
expense, shall be paid by Maxxim. Maxxim shall also bear all
applicable taxes, duties, and similar charges that may be
assessed against the InnerDyne Devices after delivery to the
carrier at InnerDyne's Distribution Site unless such
additional charges arise from InnerDyne's failure to properly
pack or package the InnerDyne Devices.
(h) Obligations to Supply and Purchase. InnerDyne shall allocate
sufficient resources, capital equipment, materials, tools and
labor to enable it to timely supply the InnerDyne Devices
required by Maxxim pursuant to its properly placed purchase
orders. For so long as InnerDyne continues to meet its supply
obligations hereunder during the Term hereof, Maxxim shall
have no right to manufacture, or have manufactured, InnerDyne
Devices, and Maxxim shall purchase its full requirements of
such InnerDyne Devices solely from InnerDyne.
(i) Manufacturing Practices. All InnerDyne Devices shall be
manufactured in accordance with applicable current QSR
standards promulgated by the FDA and shall be CE Xxxx
certifiable. The InnerDyne Devices shall be manufactured in a
facility registered with
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and approved for such purpose by the FDA . InnerDyne shall,
at its sole cost and expense, obtain the approval for U.S.
Food and Drug Administration 510(K) filing No. K992668, which
shall be incorporated in the Specifications listed on Exhibit
A. InnerDyne shall not implement any change in the
manufacturing process relating to the InnerDyne Device which
would significantly, materially and/or adversely affect the
quality or character of the InnerDyne Devices, or which would
affect regulatory clearance, without Maxxim's prior written
approval. Maxxim and its agents shall have the right to
conduct audits during the terms of this Agreement upon
reasonable notice at InnerDyne's manufacturing facilities to
verify InnerDyne's compliance with such QSR and other
regulatory regulations; provided, however, that such audits
shall not occur more than once in each quarter of a twelve
(12) month period without InnerDyne's prior approval. In the
event of significant manufacturing problems, product
complaints, quality control problems or other problems
affecting the quality of supply of InnerDyne Devices, the
frequency of such audits may be increased upon reasonable
notice to InnerDyne. Further, Maxxim shall conduct an audit
prior to the Effective Date for the purpose of becoming
familiar with the quality control and other procedures at the
facility.
4. WARRANTY FOR INNERDYNE DEVICES.
(a) InnerDyne Warranty. InnerDyne warrants that the InnerDyne
Devices shall conform to the Specifications in the attached
Exhibit "A", shall be free from defects in all respects and
shall adhere to the quality standards of the FDA.
(b) Rejection of InnerDyne Devices. Maxxim shall inspect all
InnerDyne Devices promptly upon receipt thereof and may reject
any product that fails in any material way or, in Maxxim's
judgment, in any significant way, to meet the Specifications
set forth in Exhibit "A". Any device not properly rejected
within a reasonable period of time following Maxxim becoming
aware of such failure (the "Rejection Period") shall be deemed
accepted; provided, however, that with respect to any latent
defects or defects which do not meet the Specifications and
which may not have been noticeable upon initial inspection,
Maxxim shall have twenty (20) days from the time Maxxim
notices such failure to reject such Device. Further provided
that to the extent that such failure is not discovered until
received by one of Maxxim's customers, Maxxim may still reject
such Products for a full refund or replacement within a
reasonable period of time following receipt by Maxxim of
notice from the customer. As promptly as possible but no later
than thirty (30) working days after receipt of properly
rejected InnerDyne Devices, InnerDyne shall, at its option and
expense, replace the InnerDyne Devices that do not meet
specifications. InnerDyne shall pay all shipping charges for
the rejected products to be sent by Maxxim to InnerDyne and
for the replacement products to be sent back to Maxxim.
Further, in the event of a recall due solely to the failure of
InnerDyne Devices to meet the Specifications, InnerDyne shall
accept the return for a full refund of all affected InnerDyne
Devices and shall reimburse Maxxim up to, and not to exceed,
[***] of the refund to reimburse Maxxim for their reasonable
expenses associated with the recall.
(c) No Other Warranty. OTHER THAN AS EXPRESSED HEREIN,
INNERDYNE GRANTS NO OTHER WARRANTIES FOR THE INNERDYNE
DEVICES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION
OF LAW, BY
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STATUTE OR OTHERWISE, AND INNERDYNE SPECIFICALLY DISCLAIMS
ANY IMPLIED WARRANTY OF MERCHANTABILITY AND WARRANTY OF
FITNESS FOR A PARTICULAR PURPOSE.
(d) Limitation of Liability. INNERDYNE'S LIABILITY WITH
RESPECT TO THE REJECTED INNERDYNE DEVICES SHALL BE LIMITED TO
A REFUND OF THE AMOUNT PAID FOR THE INNERDYNE DEVICES. IN NO
EVENT SHALL INNERDYNE BE LIABLE FOR COSTS OF PROCUREMENT OF
SUBSTITUTE GOODS BY ANYONE. IN NO EVENT SHALL INNERDYNE BE
LIABLE TO MAXXIM OR ANY OTHER ENTITY FOR ANY SPECIAL,
CONSEQUENTIAL, INCIDENTAL, OR INDIRECT DAMAGES, HOWEVER
CAUSED, ON ANY THEORY OF LIABILITY OR BREACH OF WARRANTY,
WHETHER OR NOT INNERDYNE HAS BEEN ADVISED ON THE POSSIBILITY
OF SUCH DAMAGE.
(e) Insurance. InnerDyne shall at all times during the
Initial Term and any Renewal Term, and for a period of five
(5) years thereafter, maintain in full force and effect, at
InnerDyne's sole cost and expense, a general liability
insurance policy, product liability, and property damage
insurance for claims that might arise regarding the InnerDyne
Devices. Such insurance will contain a minimum combined
single limit of liability for bodily injury and property
damage in amounts not less than $3,000,000.00 per occurrence
and $3,000,00.00 in the aggregate. InnerDyne shall provide
Maxxim within fifteen (15) days following the Effective Date,
an insurance certificate indicating the foregoing coverage by
an insurance company licensed to do business in the relevant
states and signed by an authorized agent.
5. ADDITIONAL OBLIGATIONS OF MAXXIM MEDICAL
(a) Laws and Government Approvals. Maxxim shall comply fully,
at its expense, with any and all applicable health and safety
laws, regulations and obtain any necessary FDA and Government
Approvals, if required, for the sale of the InnerDyne Devices
in the Territory.
(b) Purchase Commitment. Maxxim hereby agrees to purchase
from InnerDyne during the [***] following the Effective Date
(the "[***] Purchase Commitment") the applicable number of
InnerDyne Devices set forth on Exhibit "B". Maxxim's [***]
Purchase Commitment shall be wholly conditioned upon
InnerDyne's ability to supply the InnerDyne Devices to enable
Maxxim to meet such commitments. In the event InnerDyne fails
to supply sufficient quantities of InnerDyne Devices in
conformity with the Specifications to allow Maxxim to meet
their [***] Purchase Commitments, Maxxim shall be released
from all such [***] Purchase Commitments.
(c) Representations. Maxxim shall not knowingly make any false
or misleading representations to customers or others
regarding InnerDyne or the InnerDyne Devices. Maxxim and its
employees and agents shall not make any representations,
warranties or guarantees with respect to the specifications,
features or capabilities of the InnerDyne Devices that are
not consistent with InnerDyne's representations, warranties
and guarantees, regulatory filing documentation or this
Agreement, including InnerDyne's standard limited warranty
and disclaimers.
[***] Confidential material redacted and filed separately with the Commission.
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6. TERM AND TERMINATION
(a) Term. This Agreement shall commence on the Effective Date and
continue in full force and effect for a fixed term of [***]
from such date (the "Initial Term"), unless terminated earlier
under the provisions of this Section 6. Unless terminated
earlier, this Agreement shall be, at Maxxim's option, renewed
for [***] (the "Renewal Term") upon expiration of the Initial
Term, provided, however, that Maxxim, at its sole option, may
elect not to renew the Agreement for the Renewal Term upon no
less than ninety (90) days notice prior to the end of the
current Term to InnerDyne. In the event Maxxim elects to renew
this agreement, the [***] Purchase Commitments under the
renewal agreement shall in no event be less than [***] of the
immediately preceding [***] Minimum Purchase Commitments,
unless agreed to in writing by both parties.
(b) Termination for Cause. If either party defaults in the
performance of any material provision of this Agreement, then
the non-defaulting party may give written notice to the
defaulting party that if the default is not cured within thirty
(30) days the Agreement will be terminated. If the
non-defaulting party gives such notice and the default is not
cured or if reasonable measures have not been taken by such
party to cure the default, during such thirty (30) day period,
then the Agreement shall automatically terminate at the end of
that period.
(c) Termination upon a Change in Control. In the event that
InnerDyne undergoes a Change in Control, as defined herein,
which results in a majority ownership, directly or indirectly,
of InnerDyne by a direct competitor of Maxxim, Maxxim shall
have the right, in its sole and absolute discretion, to
terminate this Agreement immediately upon the occurrence of the
Change in Control. Upon such termination, Maxxim shall have no
further obligations hereunder except for those payment
obligations accrued prior to the date of termination. Maxxim
agrees to provide, within 30 days of the effective date of this
agreement, a list of their current direct competitors.
(d) Limitation on Liability. In the event of termination by either
party in accordance with any of the provisions of this
Agreement, neither party shall be liable to the other for
indirect, consequential, punitive, special, exemplary or
incidental damages arising out of this Agreement. Termination
shall not, however, relieve either party of obligations
incurred prior to the termination.
(e) Survival of Certain Terms. The provisions of Sections 4, 6(d),
7(a), 7(b), 7(c), 7(d), 8(a), 9, 10, and 11 shall survive the
termination of this Agreement for any reason for the time
period specified therein, and if not specified, for an
indefinite period. All other rights and obligations of the
parties shall cease upon termination of this Agreement.
7. PROPERTY RIGHTS AND CONFIDENTIALITY
(a) Property Rights of InnerDyne. Maxxim agrees that InnerDyne owns
all right, title, and interest in and to all of InnerDyne's
patents, trademarks, trade names, inventions, copyrights,
know-how, and trade secrets relating to the design,
manufacture, operation or service of the InnerDyne Devices. The
use by Maxxim of any of these property rights is authorized
only for the purposes herein set forth, and upon termination of
this
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Agreement for any reason such authorization shall cease.
Provided, however, that in the event that, upon termination,
Maxxim has an inventory of InnerDyne Devices, Maxxim shall be
permitted to sell the products in inventory and shall possess
the property rights to properly sell such products until the
inventory is depleted.
(b) Property Rights of Maxxim. InnerDyne agrees that Maxxim owns
and shall own all right, title, and interest in and to any
Maxxim Products and the Systems developed by Maxxim as
discussed herein and to all patents, trademarks, trade names,
inventions, copyrights, designs, know-how and trade secrets
relating to the Maxxim Products and the Systems, except solely
with respect to the InnerDyne Devices individually.
(c) Sale Conveys no Right to Manufacture or Copy. The InnerDyne
Devices are offered for sale and are sold by InnerDyne subject
in every case to the condition that such sale does not convey
any license, expressly or by implication, to manufacture,
duplicate or otherwise copy or reproduce any of the InnerDyne
Devices. Maxxim shall take appropriate steps with Maxxim's
customers, as InnerDyne may reasonably request, to inform them
of the restrictions contained in this Subsection 7(c). This
provision shall survive termination for a period of five (5)
years.
(d) Confidentiality.
(i) Each party acknowledges that by reason of its relationship
to the other hereunder, it will have access to certain
proprietary information and materials concerning the other
party's business, plans, customers, technology, and
InnerDyne Devices, which information is designated as
confidential when conveyed orally, in writing or through
other tangible materials (the "Confidential Information").
Each party agrees that it will not use in any way for its
own account or the account of any third party (except for
the purpose of performing its obligations under this
Agreement), nor disclose to any third party, any such
Confidential Information revealed to it by the other party
without the express written consent of the disclosing
party except as required by applicable law, rule,
regulation or legal process. The parties further agree to
use the same degree of care concerning Confidential
Information as it uses to protect its own confidential and
proprietary technical information to prevent the
unauthorized disclosure to any third party of the
Confidential Information received from the disclosing
party hereunder. The parties agree that they shall acquire
no rights with respect to Confidential Information of the
other party received hereunder. The parties agree that the
Confidential Information received by a disclosing party
hereunder shall not be disclosed to any third party or any
employee, officer or director of the receiving party,
except to those employees, officers and directors whose
responsibilities require such disclosure for purposes of
performing the parties' obligations under this Agreement;
provided that such employees, officers, and directors have
entered into confidentiality agreements with provisions
substantially similar to those set forth in this Section
7(d).
(ii) The obligations hereunder shall not apply to Confidential
Information:
(a) which the receiving party can demonstrate by
written records was known to the receiving party
prior the date of disclosure by the disclosing party;
provided that such information was not knowingly
obtained by the receiving
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party through disclosure by a third party receiving
such information in confidence from the disclosing
party;
(b) which is now in the public knowledge, or becomes
public knowledge in the future other than by breach
of this Agreement by the receiving party;
(c) which, as can be established by written records, is
independently developed by the receiving party
without benefit of Confidential Information received
from the disclosing party;
(d) which is disclosed to the receiving party, after the
date of disclosure by the disclosing party, by a
third party having a right to make such disclosure;
or
(e) which is required to be included in any filing or
action taken by the receiving party to obtain
government approval to market the InnerDyne Devices;
provided however, that when permitted by the
provisions of local laws, the receiving party shall
use its reasonable best efforts to protect the
confidentiality of such Confidential Information
submitted to governmental agencies or authorities
pursuant to this Agreement.
(iii) Upon request following termination of this Agreement,
the receiving party shall either (1) return to the
disclosing party or (2) destroy and certify in writing as
to the destruction of any tangible copies of any
Confidential Information provided to it by the disclosing
party hereunder, and any notes taken by employees,
officers and directors of the receiving party regarding
the Confidential Information disclosed to it.
(iv) The obligations of this Section 7(c) shall (i) apply to
Confidential Information relating to the subject matter of
this Agreement disclosed prior to the execution hereof and
(ii) survive termination of this Agreement for any reason
for a period of two (2) years.
(v) The terms and provisions of this Section 7(c) shall
supersede in their entirety the terms and provisions of
that certain Mutual Nondisclosure Agreement, dated as of
February 23, 2000 between InnerDyne and Maxxim (the
"NDA"). The use and disclosure of any "Confidential
Information" (as such term is defined in the NDA) provided
under the NDA shall be governed hereinafter by this
Agreement.
8. TRADEMARKS AND TRADE NAMES
(a) Use. During the term of this Agreement, Maxxim shall have the
right to use InnerDyne's INNERVASC trademark. Except as set
forth in this Section 8, nothing contained in this Agreement
shall grant to Maxxim any right, title or interest in
InnerDyne's Trademarks other than INNERVASC nor grant Maxxim
the right to use the InnerDyne name except as expressly
approved by InnerDyne. At no time during or after the Term of
this Agreement shall Maxxim challenge any InnerDyne
Trademarks.
(b) Approval of Representations. All types of representations
of InnerDyne trademarks that Maxxim intends to use shall first
be submitted to InnerDyne for approval, which shall not be
unreasonably withheld, of design, color, and other details or
shall be exact copies of those used by InnerDyne. Once a
particular type of representation is
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approved by InnerDyne, Maxxim may continue to reproduce and
reuse such representation without prior approval for each use.
9. PATENT, COPYRIGHT, AND TRADEMARK INDEMNITY
(a) Indemnification. Maxxim agrees that InnerDyne has the right to
defend, or at InnerDyne's option to settle, and InnerDyne
agrees, at InnerDyne's own expense, to defend or at
InnerDyne's option to settle, any claim, suit or proceeding
brought against Maxxim or Maxxim's customers on the issue of
infringement of any United States of America patent, copyright
or trademark on the InnerDyne Devices sold hereunder or the
use thereof, subject to the limitations hereinafter set forth.
Maxxim agrees to promptly notify InnerDyne of any alleged
infringement of patents, copyrights or trademarks, and to
cooperate and use reasonable efforts to assist InnerDyne in
any investigation, defense or settlement of such alleged
infringement. InnerDyne shall have sole control of any such
action or settlement negotiations to the extent that Maxxim is
not affected thereby. In all other cases, InnerDyne shall keep
Maxxim informed and shall consult with Maxxim as to any
resolution thereof.
(b) Limitation. Notwithstanding the provisions of Subsection 9(a)
above, InnerDyne assumes no liability for (1) infringements
arising from the composition, assembly, combinations, method
or process by Maxxim in which any of the InnerDyne Devices may
be used, including as part of the Systems, but not covering
the InnerDyne Devices when used alone; (2) trademark
infringements involving any marking or branding not approved
by InnerDyne or involving any marking or branding created by
Maxxim; or (3) infringements relating solely to Maxxim's
modification of the InnerDyne Devices, or any part thereof,
unless such modification was done by InnerDyne.
(c) Disruption. In the event that any action discussed in this
Section 9 prevents Maxxim from continuing to distribute the
InnerDyne Devices, Maxxim may return all such products for a
full refund.
10. INDEMNIFICATION
InnerDyne and Maxxim each agree to indemnify and hold the other
party harmless from and against any and all claims made by any
person or entity arising out of the processing, marketing,
distribution and sale of the InnerDyne Devices or the Systems,
where and to the extent such damages have been caused by the
negligent act or omission or fault of such party or its employees
or agents or by virtue of a breach by the indemnifying party of any
provision hereof. The indemnifying party shall have the right to
defend or, at its option, but only upon consent of the indemnified
party, to settle such claims, and if it chooses to exercise such
right, it shall have control over any such claim or settlement
negotiations subject to obtaining the prior consent of the
indemnified party. The indemnifying party shall be relieved of the
foregoing obligations unless the indemnified party gives prompt
notice in writing of any such claim, suit, or proceeding and, at
the indemnifying party's expense, gives the indemnifying party
proper and full information and reasonable assistance to settle
and/or defend any such claim, suit, or proceeding; provided,
however, that without relieving the indemnifying party of its
obligations hereunder or impairing the indemnifying party's right
to control the defense or settlement thereof, the indemnified
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party may elect to participate through separate counsel in the
defense of any such claim, but the fees and expenses of such
counsel shall be at the expense of such indemnified party unless
(a) the employment of counsel by such indemnified party has been
authorized in writing by the indemnifying party, (b) the
indemnified party shall have reasonably concluded that there
exists a material conflict of interest between the indemnifying
party and such indemnified party in the conduct of the defense of
such claim (in which case the indemnifying party shall not have
the right to control the defense or settlement of such claim on
behalf of such indemnified party) or (c) the indemnifying party
shall not have employed counsel to assume the defense of such
claim within reasonable time after notice of the commencement
thereof. In each of such cases the reasonable fees and expenses
of counsel shall be at the expense of the indemnifying party.
11. MISCELLANEOUS
(a) Governing Law and Jurisdiction. This Agreement shall be
governed by, and construed and interpreted in accordance with,
the laws of the State of Delaware, without reference to
conflict of law principles or statutory rules of arbitration.
The federal and state courts within the State of Delaware
shall have exclusive jurisdiction to adjudicate any dispute
arising out of this Agreement. InnerDyne hereby expressly
consents to (i) the personal jurisdiction of the federal and
state courts within the State of Delaware , (ii) service of
process being effected upon Maxxim by registered mail sent to
the address set forth at the beginning of this Agreement and
(iii) the uncontested enforcement of a final judgment from
such courts in any other jurisdiction wherein Maxxim or any of
Maxxim's assets are present.
(b) [***] Feasibility Study. InnerDyne agrees that Maxxim shall be
entitled, for a [***] period following the Effective Date to
conduct a market feasibility study in [***] and other areas
InnerDyne may agree to for the possible sale of the Systems.
If Maxxim so elects, the parties hereby agree to enter into
good faith negotiations to enter into a Supply, License and
Distribution agreement substantially similar to the Terms of
this agreement and with reasonable Minimum [***] Purchase
Commitments covering the Additional Territory.
(c) Entire Agreement. This Agreement sets forth the entire
Agreement and understanding of the parties relating to the
subject matter herein and merges all prior discussions between
them. No modification of or amendment to this Agreement, nor
any waiver of any rights under this Agreement, shall be
effective unless in writing signed by the party to be charged.
(d) Notices. Any notice required or permitted by this Agreement
shall be in writing and shall be sent by telex, telecopier or
telegram or by prepaid registered or certified mail, return
receipt requested, addressed to the other party at the address
shown at the beginning of this Agreement or at such other
address for which such party gives notice hereunder. Such
notice shall be deemed to have been given upon the earlier of
receipt by the party to whom notice was sent or three (3) days
after deposit in the mail.
(e) Force Majeure. Non performance of either party shall be
excused to the other extent that performance is rendered
impossible by strike, fire, flood, governmental acts or
orders or restrictions, failure of suppliers, or any other
reason where failure to perform
[***] Confidential material redacted and filed separately with the Commission.
12
is beyond the reasonable control of and is not caused by the
negligence or fault of the non-performing party.
(f) Assignment. Except as otherwise provided herein, neither party
hereunder may assign its rights or delegate its duties under
this Agreement without the prior written consent of the other,
provided, however, that each party hereunder may, without such
consent, assign this Agreement to any Affiliate or any
successor by merger or sale of substantially all of its
business units to which this Agreement relates. Any attempted
assignment or delegation in contravention of the foregoing
shall be void and of no effect.
(g) Legal Expenses. The prevailing party in any legal action
brought by one party against the other and arising out of this
Agreement shall be entitled, in addition to any other rights
and remedies that such prevailing party may have, to
reimbursement for expenses incurred by such prevailing party,
including court costs and reasonable attorneys' fees.
(h) Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original and
all of which together shall constitute one instrument.
(i) Partial Invalidity. If any provision of this Agreement is held
to be invalid, then the remaining provisions shall
nevertheless remain in full force and effect. The parties
agree to renegotiate in good faith any term held invalid and
to be bound by the mutually agreed substitute provision.
(j) Publicity. InnerDyne and Maxxim shall agree upon the
publication time and date of any press release or other public
statement announcing this Agreement or any transaction
contemplated under this Agreement. Neither party shall make
any public statement prior to the public release of such press
release except as may be required by law, judicial order or
any listing agreement with a national securities exchange or
over-the-counter trading system to which InnerDyne or Maxxim
is a party. Except as permitted by this Section 11(j) or
except as required by law, judicial order or any listing
agreement with a national securities exchange or
over-the-counter trading system to which InnerDyne or Maxxim
is a party, neither party shall disclose the terms and
conditions of this Agreement unless expressly authorized to do
so by the other party, which authorization shall not be
unreasonably withheld; provided that disclosure is expressly
permitted by either party to its attorneys and accountants on
a confidential basis. Notwithstanding the foregoing, InnerDyne
may disclose on a confidential basis the terms and conditions
of this Agreement to potential underwriters in connection with
any proposed public offering by InnerDyne or to third parties
interested in merging with or acquiring or entering into a
corporate partner transaction with InnerDyne.
(k) Export. Each party acknowledges that the laws and regulations
of the United States restrict the export and re-export of
commodities and technical data of United States origin. Each
party agrees that it will not export or re-export the
technical data of the other party in any form without any
required United States and foreign government licenses.
13
IN WITNESS WHEREOF, the undersigned are duly authorized to execute this
Agreement on behalf of InnerDyne and Maxxim, as applicable.
INNERDYNE, INC. MAXXIM MEDICAL, INC.
/s/ Xxxxxxx X. Xxxxxx /s/ Xxxx Xxxxxx
------------------------------------- ----------------------------------
Print Name: XXXXXXX X. XXXXXX Print Name: XXXX XXXXXX
-------------------------- -----------------------
Title: PRESIDENT/CEO Title: EVP SALES & MARKETING
-------------------------------- ----------------------------
14
EXHIBIT "A"
INNERDYNE PRODUCT DESCRIPTION, PRODUCT SPECIFICATIONS AND PURCHASE PRICE
PRODUCT DESCRIPTION: InnerDyne's REVAS 006 (nosecone) vascular access device
MAXXIM PURCHASE PRICE: [***]
(U.S. DOLLARS)
PRODUCT SPECIFICATIONS:
Sleeve Dimensions
1 The sleeve must have a working length of 3.700" [***]".
(The working length is defined as the distance between the
distal end of the sleeve and the distal edge of the middle
handle of the three-piece sleeve handle.)
2 The maximum diameter of the sleeve does not exceed
[***]" of the distal tip.
3 The distal end of the sleeve must have no exposed braid
fibers prior to dilation.
Nosecone Dimensions
1 The ID of the distal tip of the nosecone must be [***]".
2 The maximum OD of the tapered portion of the nosecone must
be less than [***]".
3 The overall nosecone assembly length must be [***]".
Dilation with a 12 F dilator
1 The dilation of the sleeve to 12F (.158") must not cause
the sleeve to shorten by more than [***].
2 The dilation of the sleeve to 12F must not cause the
three-piece sleeve handle to crack.
3 The dilation of the sleeve to 12F must not cause the
distal tip to split resulting in braid fibers of greater
than [***]" being exposed.
4 The dilation of the sleeve to 12F must not cause the
urethane at the distal tip of the device to stretch or
extend more than [***]".
5 The dilation of the sleeve to 12 F must not cause any
sleeve material to come free from the device
THE 510K FILING NO. K992668 SHALL BE ATTACHED HERETO AND SHALL BE INCORPORATED
HEREIN.
[***] Confidential material redacted and filed separately with the Commission.
15
EXHIBIT "B"
[***]
[***] Confidential material redacted and filed separately with the Commission.
