EXHIBIT 10.14
DAIKIN MEDICAL IMPLANT COMPLIANCE AGREEMENT
This COMPLIANCE AGREEMENT ("Agreement") is made and entered into on April
1, 1996, by and between DAIKIN AMERICA, INC., having its business office at
00 Xxxxxxx Xxxxx, Xxxxxxxxxx, Xxx Xxxx 00000 ("DAI") and XOMED SURGICAL
PRODUCTS, INC., having its principal business office at 0000 Xxxxxxxxxx
Xxxxx Xxxxx, Xxxxxxxxxxxx, XX 00000 ("XOMED").
In consideration of the premises contained herein, the parties understand
and agree as follows:
1. This Agreement shall apply to DAI's sale and XOMED's purchase from DAI of
all DAI fluoropolymers, including, but not limited to PTFE, FEP, CTFE, ETFE
(the "Products"), which XOMED has stated that it is using or intends to
use, in whole or in part, in the design, production, sale and distribution
of materials for use in medical and/or dental devices which are implanted
in the human body or which come into contact with internal body fluids or
tissues.
2. XOMED recognizes that the Products are not specifically designed or
manufactured for implantation in the human body or contact with internal
body fluids or tissue and that DAI has neither undertaken any research and
testing of the Products specifically designed to determine suitability or
safety in medical and/or dental use nor has it sought certification for the
Products for such use.
3. XOMED recognizes that DAI, as a bulk supplier, does not make any specific
recommendations as to the end use of the Products, nor is it in a position
to control or predict how the Products are processed and marketed. The
determination of the suitability or fitness of the Products for the use
contemplated by XOMED or its customers is the sole responsibility of XOMED
or its customers, whichever the case may be, and DAI shall have no
responsibility in that connection.
4. DAI makes no representation, promise or warranty (express or implied) as to
the fitness of the Products for use in medical and/or dental devices; and
XOMED agrees that it will neither represent to others that DAI permits,
recommends or endorses such use nor that it will refer to or use the DAI
name or trademarks in association with any material used for any medical
and/or dental device.
5. XOMED manufactures various materials and finished products and DAI
considers XOMED to be technically capable and knowledgeable to use the
Products in its manufacturing processes and to market and distribute the
materials and finished products. XOMED agrees to use the Products only for
ear tubes that have received proper approval from
government regulations agencies. XOMED will consult with Daikin before
using the Products for devices to be implanted in the human body for more
than 30 days.
6. XOMED shall defend, indemnify and hold harmless DAI against and from any
and all claims, suits, liabilities, damages, losses, costs and expenses
alleging bodily injury or property damage arising out of, caused by or
resulting from XOMED's use of the Products in the production of materials
for use in any medical and/or dental device. DAI will give prompt notice to
XOMED of any claim or suit that may give rise to the foregoing obligations
so that XOMED can immediately assume and direct the investigation and
defense of any such claim or suit; and DAI will fully cooperate with XOMED
in connection therewith.
7. DAI shall have the right, but not the obligation, to participate in the
investigation and defense of any claim or suit to which this Agreement
applies, but such shall be at its own expense with counsel of its own
choice.
8. As security for the undertakings described in paragraph 6, XOMED shall
obtain and maintain a policy (or policies) of liability insurance with
respect to the Products to which this Agreement applies. The limits of
liability of such insurance must be acceptable to DAI and such insurance
must include Daikin Industries, Ltd. and DAI as additional named insureds
with respect to the Products which are purchased from it by XOMED for use
in the production of materials for use in any medical and/or dental device.
Such insurance shall be exclusively applicable to any claim, suit,
liability, damage, loss, cost or expense arising out of, caused by or
resulting from XOMED's use of the Products in the production of materials
for use in any medical and/or dental device, and it shall provide a waiver
of subrogation by endorsement or otherwise.
9. XOMED shall furnish to DAI a copy of such insurance and shall also provide
it with sixty (60) days prior written notice of cancellation or material
change in such insurance. XOMED shall not cancel such insurance without
DAI's prior written consent.
10. XOMED shall not resell the Products in their raw form to any person or
entity for use in medical and/or dental devices of any kind or nature.
11. To the extent that any terms and conditions in this Agreement are
inconsistent with those in DAI's standard sales contract/purchase order
and/or the Consignment and Security Agreement between DAI and XOMED, this
Agreement shall take precedence and the others shall be subject to it.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to
be executed and delivered by their respective duly authorized representatives as
of the day, month and year first above written.
DAIKIN AMERICA, INC.
Signature: /s/ X.X. Xxxxxx DATE: 6/24/96
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Name: X.X. Xxxxxx
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Title: VP
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XOMED SURGICAL PRODUCTS, INC.
Signature: /s/ F. Xxxxx Xxxx DATE: June 19, 1996
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Name: F. Xxxxx Xxxx
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Title: Sr. V.P. & C.O.O.
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