EXHIBIT 10.22
EXCLUSIVE LICENSE AGREEMENT
THIS AGREEMENT is effective as of the 6th day of May, 1997 (the
"Effective Date"), by and between XXXXXX HEALTHCARE CORPORATION, a Delaware
Corporation (hereinafter referred to as "BAXTER"), acting through its Xxxxxxx
Critical-Care Division, having an address at 00000 Xxxxxxx Xxxxxx, Xxxxxx,
Xxxxxxxxxx 00000 and IMPLEMED, INC. a Massachusetts corporation, having offices
at 000 Xxxxxxxx Xxxxxx, Xxxxxxxxx Xxxxxxxxxxxxx 00000 (hereinafter referred to
as "LICENSOR").
WITNESSETH
WHEREAS, LICENSOR has developed and owns technical know-how, patent
applications and patents relating to the manufacture of anti-microbial polymers;
WHEREAS, LICENSOR is capable of manufacturing or having manufactured
anti-microbial polymers and maintains a staff of employees capable of
instructing others in the manufacture of anti-microbial polymers and of
conveying such technical know-how as is required to allow manufacture of
anti-mircobial polymer by third parties; and
WHEREAS, BAXTER wishes to acquire an exclusive license under such
patent applications, patents and such technical know-how owned by LICENSOR so
that BAXTER can (1) initially purchase anti-mircobial polymers from LICENSOR for
use in XXXXXX'x development and manufacture of covered catheters and
introducers, as defined below and (2) eventually receive technical know-how from
LICENSOR to allow BAXTER to manufacture or have manufactured anti-microbial
polymers for use in XXXXXX'x production of covered catheters and introducers, as
defined below.
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I. Definitions
Terms in this Agreement which are set forth in upper case lettering
have and bear the meanings established for such terms in the succeeding sections
of this Article I.
Section 1.01. "FIELD OF TECHNOLOGY" shall mean the manufacture of
anti-microbial polymers made using LICENSOR's OLIGON TECHNOLOGY as may be used
or useful in the development and/or production of COVERED DEVICES.
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Section 1.02 "COVERED DEVICES" shall mean pulmonary artery catheters,
vascular access introducers and short-term, non-tunneled, over-the-wire central
venous catheters of any lumen configuration (including hi-flow central venous
catheters which may be used for dialysis, when designed and marketed for primary
use within the hospital and not specifically for renal dialysis). Specifically
excluded are peripherally inserted central catheters (PICC's), mid-line
catheters, dialysis catheters (except as described above) and the COMPOUND
itself.
Section 1.03. "TECHNICAL KNOW-HOW" shall mean INVENTIONS, technical
data, designs, plans, specifications, methods, processes, systems, clinical data
and other information or documentation, whether patentable or not, relating to
the FIELD OF TECHNOLOGY which is in the possession of LICENSOR as of the
Effective Date or which is owned by LICENSOR (or which LICENSOR has the right to
license to BAXTER) at any time during the term of this Agreement. TECHNICAL
KNOW-HOW shall not include any information, and/or documentation which was
previously known by BAXTER (except for confidential disclosures previously made
by LICENSOR to Baxter), or which is or later becomes publicly known through no
act or failure to act by BAXTER.
Section 1.04 "INVENTION(S)" shall mean, without restriction or
limitation, any and all devices, processes (including without limitation
processes of using devices or of manufacturing such devices), compositions of
matter, computer software, chemical formulations, ideas or developments, whether
patentable or unpatentable and any and all written materials or other works
which may be subject to copyright, which are conceived, reduced to practice, or
written prior to or during the terms of this Agreement, and which related to the
FIELD OF TECHNOLOGY.
Section 1.05 "LICENSOR INVENTIONS" shall mean those INVENTIONS
independently conceived, reduced to practice or written by LICENSOR, without the
technical assistance or technical contribution of BAXTER.
Section 1.06 "BAXTER INVENTIONS" shall mean those INVENTIONS
independently conceived, reduced to practice or written by BAXTER, without the
technical assistance or technical contribution of LICENSOR.
Section 1.07. "JOINT INVENTIONS" shall means those INVENTIONS jointly
conceived, reduced to practice, or written by BAXTER and LICENSOR.
Section 1.08 "LICENSED PATENTS" shall mean any United States or foreign
patents and patent applications (including any continuation,
continuation-in-part, divisional, reissues or reexamination patent applications
thereof and patents issuing therefrom) relating to the FIELD OF TECHNOLOGY or
relating to any INVENTIONS in which LICENSOR has a present interest, or
hereafter acquires an interest, including but not limited to the pending patent
applications and patents listed in Appendix A hereto.
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Section 1.09 "LICENSED PRODUCTS" shall mean any COVERED DEVICE which is
within the scope of one or more claims of a LICENSED PATENT or incorporate any
part or all of the TECHNICAL KNOW-HOW.
Section 1.10 "COMPOUND" shall mean compositions of matter which are
within the scope of one or more claims of a LICENSED PATENT or incorporate any
part or all of the TECHNICAL KNOW-HOW.
Section 1.11 "FIRST COMMERCIAL SALE" shall mean the first sale to a
third party of a LICENSED PRODUCT anywhere in the world under the approval of
appropriate governmental agencies (if any) for distribution and sale of such
LICENSED PRODUCT.
Section 1.12 "NET SELLING PRICE" shall mean, for any calendar quarter,
the average per unit billing price which BAXTER or an AFFILIATE charges to their
United States customers for a 7F, 3 lumen central venous catheter set (which
includes a dilator and a guide wire and which is further described in Appendix F
hereto), excluding sales, use, occupation and excise taxes, duties, and
transportation costs, returns and allowances in lieu of returns.
Section 1.13 "AFFILIATES" shall mean any person or entity, excluding
Xxxxxx International, Inc., controlling, controlled by or under common control
with BAXTER.
Section 1.14 "OLIGON TECHNOLOGY" shall mean LICENSOR's proprietary and
confidential technology for manufacturing anti-microbial polymers by either (i)
the inclusion of two or more dissimilar metals in a conductive polymer matrix or
(ii) the combining of two or more dissimilar metals into an iontophoretic
structure which is in turn included in a polymer matrix.
Section 1.15 "OLIGON TRADEMARKS" shall mean the trademarks and logos
listed in Appendix C hereto.
Section 1.16 "CONFIDENTIAL INFORMATION" shall mean information whose
confidentiality is protected in accordance with Section 13.09 below.
Section 1.17. "COMPOUND PRICE" shall mean a price which is initially
One Hundred Thirty Dollars ($130.00) per pound of COMPOUND, and which may be
adjusted from time to time in accordance with Section 4.01(c) below.
Section 1.18. "SPECIFICATIONS" shall mean the specification as set
forth in Appendix B.
Section 1.19. "CONTINGENCIES" shall mean (i) LICENSOR's completion of
the development of the COMPOUND; and (ii) LICENSOR's establishing a Master File
pursuant to Section 6.02 below.
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Section 1.20. "CONTINGENCY QUARTER" shall mean the fourth calendar
quarter of 1998; provided, however, that if the CONTINGENCIES are not satisfied
on or before March 1, 1998, the CONTINGENCY QUARTER shall be delayed by one (1)
calendar month for each calendar month (or part thereof) by which satisfaction
of the CONTINGENCIES is delayed past March 1, 1998.
ARTICLE II. Grant of License
Section 2.01. License Grant.
(a) LICENSOR hereby grants to BAXTER a worldwide, exclusive right and
license during the term of this Agreement (i) to use the TECHNICAL KNOW-HOW to
make, have made, use, sell, offer for sale, import, lease and otherwise dispose
of LICENSED PRODUCTS; and (ii) to make, have made, use, sell, offer for sale,
import, lease and otherwise dispose of LICENSED PRODUCTS under the LICENSED
PATENTS.
(b) If a third party becomes interested in using the LICENSED PATENTS
and TECHNICAL KNOW-HOW to make or have made vascular access introducers,
LICENSOR shall encourage such third party to negotiate with BAXTER on the terms
of a supply agreement. If BAXTER and such third party are unable to agree upon
the terms of such an agreement within ninety (90) days, then, notwithstanding
the exclusive grant of rights to BAXTER as described in Section 2.01(a) above,
LICENSOR reserves the right to grant to such third party the non-exclusive right
and license to use the LICENSED PATENTS and TECHNICAL KNOW-HOW to make, have
made, xxx, sell, offer for sale, import, lease and otherwise dispose of vascular
access introducers; provided, however, that such introducers may not be sold on
a stand-alone basis and are sold, imported, leased and disposed of only in
conjunction with other medical devices which are not COVERED DEVICES.
(c) BAXTER shall have the right to make or have made the COMPOUND for
the purpose of incorporating such COMPOUND into COVERED DEVICES.
Section 2.02. Right to Use OLIGON TRADEMARKS.
(a) During the term of this Agreement, BAXTER shall use the
OLIGON TRADEMARKS on all packaging for the LICENSED PRODUCTS and may use the
OLIGON TRADEMARKS in connection with the sale, distribution, marketing and
promotion of all LICENSED PRODUCTS. At LICENSOR's request and expense, BAXTER
shall execute a registered user agreement and any other documents which LICENSOR
may reasonably request in order to establish or confirm LICENSOR's right, title
and interest with respect to the OLIGON TRADEMARKS.
(b) In order to comply with LICENSOR's quality control
standards, BAXTER shall:
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(i) maintain the quality of the LICENSED PRODUCTS by
adhering to the quality control standards regarding the OLIGON TECHNOLOGY which
are attached as Appendix C hereto; provided, however, that those standards shall
be no higher than the standards by which LICENSOR uses the OLIGON TECHNOLOGY
itself or through its licensees and assigns;
(ii) use the OLIGON TRADEMARKS in compliance with all
relevant laws and regulations;
(iii) provide LICENSOR with samples of LICENSED
PRODUCTS at LICENSOR's request and expense, in order to confirm that XXXXXX'x
use of such OLIGON TRADEMARKS is in compliance with this provision; and
(iv) not modify any of the OLIGON TRADEMARKS in any
way and not use any of the OLIGON TRADEMARKS on or in connection with any goods
or services other than the LICENSED PRODUCTS.
Section 2.03. License Grant for BAXTER INVENTIONS. BAXTER hereby grants
to LICENSOR, a worldwide, royalty-free, non-exclusive right and license (with
the right to sublicense) during the term of this Agreement to use BAXTER
INVENTIONS to make, have made, use and sell products other than COVERED
DEVICES. IF BAXTER and LICENSOR agree to extend this right and license beyond
the term of this Agreement on a royalty-bearing basis, such royalty shall be no
greater than the royalty charged by BAXTER for grants of these same rights to
third parties.
Section 2.04. No Rights by Implication. No rights or licenses with
respect to LICENSED PRODUCTS, OLIGON TECHNOLOGY, LICENSED PATENTS, TECHNICAL
KNOW-HOW, OLIGON TRADEMARKS or BAXTER INVENTIONS are granted or deemed granted
hereunder or in connection herewith, other than those rights or licenses
expressly granted in this Agreement.
ARTICLE III. Payment for License
Section 3.01. Payment for License. Within thirty (30) days after the
Effective Date, BAXTER shall pay LICENSOR a one time license fee of $265,000.00
as partial consideration for the exclusive license granted herein.
Section 3.01. Royalty. BAXTER also agrees to pay LICENSOR a royalty on
each LICENSED PRODUCT sold by or on behalf of BAXTER and its AFFILIATES from the
date of FIRST COMMERCIAL SALE. Such royalty shall be an amount equal to: (i) the
NET SELLING PRICE for the calendar quarter during which such LICENSED PRODUCT
was sold; multiplied by (ii) eighty-five percent (85%); multiplied by (iii) a
percentage royalty determined according to the following schedule:
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(a) If the LICENSED PRODUCT is covered by a LICENSED PATENT on a LICENSOR
INVENTION:
(i) Two and one half percent (2.5%) if such LICENSED PRODUCT is made from
COMPOUND supplied by LICENSOR to BAXTER; provided, however, that in no event
will the royalty paid by BAXTER for such LICENSED PRODUCT be less than $1.00
per unit.
(ii) Three and one quarter percent (3.25%) if such LICENSED PRODUCT is made
from COMPOUND manufactured by or for BAXTER other than COMPOUND supplied by
LICENSOR; provided, however, that in no event will the royalty paid by
BAXTER for such LICENSED PRODUCT be less than $1.35 per unit.
(iii) The minimum per unit royalties set forth in Section 3.02(a)(i) will
apply for the first four years of this Agreement if, during such four year
period, only LICENSOR supplies COMPOUND to BAXTER. The minimum per unit
royalties (Sections 3.02(a)(i) and (ii)) will apply for the first five years
of this Agreement if BAXTER manufactures or has manufactured COMPOUND at any
time during the first five years of this Agreement.
(b) Whenever a LICENSED PRODUCT is covered only by a LICENSED PATENT on a JOINT
INVENTION, the royalty percentage shall be one-half of the applicable royalty
percentage specified in paragraph (a) above.
(c) If a LICENSED PRODUCT is not covered by a LICENSED PATENT in a country as
the consequence of a patent validity or infringement action, but incorporates
TECHNICAL KNOW-HOW, the royalty shall be one-half of the applicable royalty
percentage specified in paragraph (a) above and shall accrue for a ten (10)
year period, beginning with the FIRST COMMERCIAL SALE of such LICENSED PRODUCT
in such country.
(d) Whenever two or more LICENSED PRODUCTS are included in a product sold as a
package (with or without other components), the royalty for such packaged
product shall be the sum of the per unit royalties for those LICENSED PRODUCTS.
Section 3.03. Minimum Quarterly Requirements.
(a) BAXTER agrees to pay a minimum royalty of $25,000 per
calendar quarter beginning the CONTINGENCY QUARTER. LICENSOR agrees that as its
sole and exclusive remedy for XXXXXX'x failure to pay any minimum royalties,
LICENSOR shall have the right to terminate this Agreement in accordance with
Section 12.02 of this Agreement. Minimum quarterly royalty payments will be made
not more than forty-five (45) days following the end of each quarter in which
minimum quarterly payments are due. Any royalty paid pursuant to this provision
for a calendar quarter will be creditable against royalties which become
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due under Section 3.02 for any LICENSED PRODUCT sold during such quarter or any
of the immediately following four (4) calendar quarters. Notwithstanding the
above, if BAXTER has initiated a clinical study intended to support a regulatory
filing or is responding to a request from the FDA for additional data (e.g.,
clinical, animal, safety or in vitro) during a calendar quarter for which a
minimum royalty is due in accordance with this Section 3.03(a), then any royalty
paid pursuant to this provision during such a calendar quarter shall be
creditable as follows: (x) such payment shall be creditable against royalties
which become due under Section 3.02 for any LICENSED PRODUCT sold during such
quarter or any of the immediately following four (4) calendar quarters; and (y)
after the period described in (x) above, 50% of any unused credits shall remain
creditable against royalties which become due under Section 3.02 for any
LICENSED PRODUCT, no matter when sold.
(b) In addition, if the CONTINGENCIES are met and BAXTER has
received FDA market clearance for any LICENSED PRODUCT, then BAXTER and its
AFFILIATES shall together sell at least the number of units of LICENSED PRODUCTS
indicated below. LICENSOR agrees that as its sole and exclusive remedy for the
failure of BAXTER and its AFFILIATES to sell such minimum number of units,
LICENSOR shall have the right to convert the rights granted in Section 2.01(a)
above to non-exclusive rights:
Time Period Minimum Quarterly Sales - # of Units
----------- ------------------------------------
If BAXTER can make or reference claims of
reduced colonization for any
LICENSED PRODUCT or vascular access product
using the OLIGON TECHNOLOGY, then
from the 17th calendar quarter following
the CONTINGENCY QUARTER 25,000
OR
--
If BAXTER can make or reference claims of
reduced blood stream infection for any
LICENSED PRODUCT or vascular access product
using the OLIGON TECHNOLOGY, then
from the 17th calendar quarter following
the CONTINGENCY QUARTER 60,000
(c) After XXXXXX'x rights under Section 2.01(a) above become
non-exclusive, if BAXTER and its AFFILIATES do not sell at least the number of
units of LICENSED PRODUCTS indicated in Section 3.03 (b) above during any three
(3) year period, then, as Licensor's sole and exclusive remedy for the failure
of BAXTER and its AFFILIATES to sell such minimum number of units, Licensor
shall have the right to terminate this Agreement in accordance with Section
12.02 below; provided, however, that: (i) if LICENSOR grants the
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same non-exclusive rights to a third party, then for the purposes of this
Section 3.03(c), the minimum number of units indicated in Section 3.03(b) above
shall be reduced by one-half; and (ii) if LICENSOR grants the same non-exclusive
rights to a third party at royalty rates lower than the rates stated in Section
3.02 above, LICENSOR shall reduce such Section 3.02 rates charged BAXTER to
those lower rates charged such third party.
Section 3.04. Date of Sale. For the purpose of computing the earned
royalties, the LICENSED PRODUCT shall be deemed to be sold as of the date it is
invoiced to an unaffiliated customer.
Section 3.05. Period of Royalty.
(a) If the LICENSED PRODUCT is covered by a LICENSED PATENT,
the applicable earned royalty shall be paid from the date of the FIRST
COMMERCIAL SALE until expiration of the last to expire LICENSED PATENT covering
the LICENSED PRODUCT in its country of manufacture or sale. If the LICENSED
PRODUCT is not covered by a LICENSED PATENT in a country, but incorporates
TECHNICAL KNOW-HOW, the applicable earned royalty shall be paid from the date of
the FIRST COMMERCIAL SALE in such country for a period of ten (10) years.
(b) Thereafter, BAXTER shall not pay any further royalties for
such LICENSED PRODUCTS in such country pursuant to Section 3.02 above.
Section 3.06. Single Royalty. A particular LICENSED PRODUCT may be sold
or disposed of more than one time, however, only one royalty shall be payable on
each LICENSED PRODUCT.
Section 3.07. Time of Payment. Payments due under Section 3.02 shall be
made on the basis of calendar quarters, and shall be made not more than
forty-five (45) days following the end of each calendar quarter. BAXTER agrees
to make payment to LICENSOR by checks mailed to LICENSOR at the address set
forth herein, or at such other address as LICENSOR may specify for that purpose.
BAXTER agrees to submit to LICENSOR, with each royalty payment, a written report
showing the number of LICENSED PRODUCTS sold in the calendar quarter and the NET
SELLING PRICE for such quarter. All payments due under Sections 3.02 and 3.03(a)
hereof but not paid by BAXTER on the due date thereof shall bear interest at the
rate which is the lesser of: (i) the rate of interest per annum charged by
Citibank N.A. to its prime commercial customers on 90-day loans plus one percent
(1%); and (ii) the maximum lawful interest rate permitted under applicable law.
Such interest shall accrue on the balance of unpaid amounts from time to time
outstanding from the date on which portions of such amounts become due and owing
until payment thereof in full.
Section 3.08. Currency for Payment. All payments made to LICENSOR
pursuant to this Agreement shall be made in United States Dollars.
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Section 3.09. XXXXXX'x Book and Records. BAXTER shall keep full and
accurate records and books of account containing all particulars necessary for
showing the amounts of royalties due LICENSOR hereunder. At all reasonable times
for a period of not more than two (2) years after the end of each reporting
year, not to exceed once each year, the books and records relating to sales of
the LICENSED PRODUCTS shall be open, at LICENSOR's request, to inspection by
LICENSOR's duly appointed Independent Certified Public Accountants, who may make
such confidential inspection of such records and books of account as is
necessary to verify the computation of royalties due to LICENSOR. Any adjustment
in the amount due the LICENSOR on account of overpayment or underpayment of
royalties shall be made at the next date when royalty payment are called for
under this Agreement.
ARTICLE IV. Manufacture and Supply of COMPOUND
Section 4.01. Sale of COMPOUND to BAXTER.
(a) LICENSOR agrees to supply BAXTER with COMPOUND manufactured to the
SPECIFICATIONS for a period of five (5) years beginning on the date of execution
of this Agreement. The agreement set forth in this Section will automatically
renew for successive one (1) year terms upon expiration on the initial five (5)
year term, unless BAXTER terminates the agreement in this Section with thirty
(30) days' prior written notice.
(b) For planning purposes, on or before January 1, 1998, BAXTER shall
submit a non-binding forecast of its orders during the next six (6) months, and
shall update that forecast on a quarterly basis thereafter. From time to time,
BAXTER shall submit purchase orders to LICENSOR for COMPOUND. LICENSOR shall
acknowledge promptly each BAXTER purchase order in writing and confirm delivery
dates to destinations specified by BAXTER; provided however, that LICENSOR shall
not be required to accept any purchase order with requested delivery dates less
than three (3) months after LICENSOR's receipt of such order. In the event of
any inconsistency between purchase orders and this Agreement, the terms of this
Agreement shall prevail. All sales of COMPOUNDS shall be subject to the terms
and conditions of this Agreement and, to the extent they specify quantities,
destinations and delivery dates, to XXXXXX'x purchase orders. LICENSOR shall
ship the COMPOUND C.I.F. destinations specified by BAXTER via mutually agreed
upon carriers. Unless otherwise agreed to in writing, LICENSOR shall pay all
freight charges and be reimbursed by BAXTER in accordance with Section 4.01(c)
below.
(c) XXXXXX agrees to pay LICENSOR for COMPOUND sold to BAXTER pursuant
to this Section the sum of:
(i) the COMPOUND PRICE; provided, however, that: (A) LICENSOR may
increase the COMPOUND PRICE in the event that the total cost
of raw materials used to formulate the COMPOUND has increased
by more than Five Dollars ($5.00) per pound of COMPOUND since
the Effective Date, such adjustment to be equal to the amount
of such increase; and (B) LICENSOR shall further adjust the
COMPOUND PRICE in the event that the total cost of raw
materials used to formulate the COMPOUND has increased or
decreased by more than Five Dollars ($5.00) per pound of
COMPOUND since the last such adjustment date, such adjustment
to be equal to the amount of such increase or decrease, so
long as the COMPOUND PRICE is never less than One Hundred
Thirty Dollars ($130.00); and
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(ii) LICENSOR's freight and insurance costs in sending COMPOUND to
the destinations specified by BAXTER.
(d) LICENSOR shall keep full and accurate records and books of account
containing all particulars necessary for documenting the adjustments to the
COMPOUND PRICE in accordance with Section 4.01(c)(i) above. At a reasonable time
within (6) months after each such adjustment is made by LICENSOR, the books and
records relating to such adjustment shall be open, at XXXXXX'x request, to
inspection by XXXXXX'x duly appointed Independent Certified Public Accountants,
who may make such confidential inspection of such records and books of account
as is necessary to verify the adjustment made by LICENSOR.
(e) Terms of payment are net 45 days from receipt of COMPOUND. All
payments due under this Section but not paid by BAXTER on the due date thereof
shall bear interest at the rate which is the lesser of: (i) the rate of interest
per annum charged by Citibank N.A. to its prime commercial customers on 90-day
loans plus one percent (1%); and (ii) the maximum lawful interest rate permitted
under applicable law. Such interest shall accrue on the balance of unpaid
amounts from time to time outstanding from the date on which portions of such
amounts become due and owing until payment thereof in full.
(f) LICENSOR shall notify BAXTER in advance and in writing of any
proposed change in the following aspects of the COMPOUND or their components:
(i) composition or source of any raw material; (ii) method of producing,
processing or testing; (iii) change in subcontractors for producing, processing
or testing; or (iv) site of manufacture. No such change shall be made without
XXXXXX'x prior written consent.
(g) All COMPOUNDS shall meet the SPECIFICATIONS and shall be subjected
to quality control inspection by LICENSOR in accordance with quality control
standards and system to be developed in conjunction with BAXTER prior to supply
of any COMPOUND to BAXTER. LICENSOR shall permit BAXTER to review periodically
LICENSOR's or it's subcontractor's production and quality control procedures and
records and to visit LICENSOR's or its subcontractor's facilities at reasonable
times with a representative of LICENSOR or its subcontractor (as the case may
be) present in order to assure satisfaction or the requirements of this
Agreement.
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(h) BAXTER may inspect or audit the COMPOUND for integrity and
adherence to the SPECIFICATIONS. If any of the COMPOUND of a continuous
production run or shipment (a "Lot") fails to meet LICENSOR's warranties or to
conform to the SPECIFICATIONS, BAXTER may, within forty-five (45) days after its
receipt of a Lot of COMPOUND, return such Lot at LICENSOR's expense for
replacement or credit. If BAXTER does not return such Lot within such time
period, BAXTER shall be deemed to have accepted such Lot, subject to LICENSOR's
warranties in Section 4.01(j) below.
(i) LICENSOR will notify BAXTER immediately of any inspection of its
facilities or its subcontractor's facilities by a federal or national agency
regulating the manufacture and sale of medical devices, as well as the results
of such inspection.
(j) LICENSOR WARRANTS THAT IT SHALL POSSESS GOOD AND MARKETABLE TITLE
TO COMPOUNDS TO BE SOLD TO BAXTER UNDER THIS AGREEMENT AT THE TIME OF SALE AND
THAT THE COMPOUNDS SHALL BE IN COMPLIANCE WITH THE SPECIFICATIONS. THESE
WARRANTIES ARE IN LIEU OF ANY OTHER WARRANTY, WHETHER EXPRESS OR IMPLIED,
WRITTEN OR ORAL (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE). In the event that COMPOUND sold to BAXTER hereunder does
not comply with the SPECIFICATIONS, XXXXXX'x sole remedy shall be to return such
COMPOUND for replacement or credit.
Section 4.02 Manufacture of COMPOUND by BAXTER. LICENSOR shall transfer
sufficient TECHNICAL KNOW-HOW to BAXTER to allow BAXTER to manufacture COMPOUND
in-house at BAXTER or at one of its AFFILIATES: (i) at XXXXXX'x option, at any
time after one (1) year from the FIRST COMMERCIAL SALE of a LICENSED PRODUCT; or
(ii) at XXXXXX'x option, at any time LICENSOR fails to deliver the COMPOUND
substantially in accordance with XXXXXX'x firm orders for the COMPOUND
(excluding reasons beyond LICENSOR's control if, for the same reason, the
technology transfer would not enable BAXTER to manufacture the COMPOUND) and
LICENSOR does not remedy such failure within sixty (60) days of written notice
from BAXTER of such failure; or (iii) at LICENSOR's option, at any time. In
connection with such transfer, LICENSOR agrees to promptly deliver and disclose
to XXXXXX'x duly authorized representatives, TECHNICAL KNOW-HOW in the form of a
complete description of LICENSOR's procedures, processes and third-party vendors
for manufacturing the COMPOUND. This transfer shall be completed in accordance
with the procedures and timetables set out in Appendix D hereto. The parties
agree that this transfer shall not in any way interfere with product
development and/or manufacturing activities required to meet any timetables or
deadlines specified elsewhere in this Agreement. In the event of (iii) above, at
XXXXXX'x request the parties shall negotiate in good faith on a longer timetable
to complete this transfer. LICENSOR agrees to provide the assistance of its
personnel as necessary to complete this transfer and the qualification of the
BAXTER manufactured COMPOUND in accordance with the SPECIFICATIONS. Each party
shall bear its own costs and expenses in connection with this transfer;
provided, however, that LICENSOR may charge
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BAXTER for its costs and expenses incurred in connection with: (x) LICENSOR's
travel expenses exceeding four (4) trips by LICENSOR personnel to XXXXXX'x
designated location in the United States; and (y) the qualification of the
BAXTER manufactured COMPOUND in accordance with the SPECIFICATIONS not being
completed within six (6) months after the date that this transfer is commenced
(or in the event of (iii) above, such longer time agreed to by the parties).
In the event any proceeding, suit or action relating to bankruptcy,
reorganization, arrangement of debt, insolvency, adjustment of debt,
receivership, liquidation or dissolution law or statute shall be filed by or
against LICENSOR, then BAXTER may obtain COMPOUND directly from LICENSOR's
vendor(s) and/or obtain a transfer of TECHNICAL KNOW-HOW to allow BAXTER to
manufacture COMPOUND from LICENSOR's vendor(s).
ARTICLE X. XXXXXX'x Other Obligations
Section 5.01. Short-Term Central Venous Catheter 510(k) Submission
Timeframe:
(a) If, within thirty (30) months after the Effective Date, BAXTER
fails to submit a request for 510(k) clearance for a LICENSED PRODUCT which is a
short-term central venous catheter, LICENSOR may convert the exclusive license
for short-term central venous catheters hereunder to a non-exclusive license;
provided, however, that in the event that LICENSOR has not obtained 510(k)
clearance for any product incorporating OLIGON TECHNOLOGY within twenty-four
(24) months after the Effective Date, then XXXXXX'x deadline to submit a request
for 510(k) clearance hereunder shall be extended to the date which is six (6)
months after the date LICENSOR obtains such clearance.
(b) If, within forty-two (42) months after the Effective Date, XXXXXX
fails to submit a request for 510(k) clearance for a LICENSED PRODUCT which is a
short-term central venous catheter, LICENSOR may terminate this Agreement in its
entirety; provided, however, that in the event that LICENSOR has not obtained
510(k) clearance for any product incorporating OLIGON TECHNOLOGY within
thirty-six (36) months after the Effective Date, then XXXXXX'x deadline to
submit a request for 510(k) clearance hereunder shall be extended to the date
which is six (6) months after the date LICENSOR obtains such clearance.
(c) If the FDA does not accept XXXXXX'x submission for 510(k) clearance
referred to above or request additional information with respect thereto, XXXXXX
shall promptly respond to the FDA and shall diligently pursue its submission.
(d) In the event that the FDA does not require a clinical study in
connection with the 510(k) regulatory submission for a LICENSED PRODUCT which is
short-term central venous catheter, then XXXXXX shall commence a clinical study
within a reasonable period of time after the FIRST COMMERCIAL SALE of a LICENSED
PRODUCT which is a short-term central venous catheter. For the purpose of
clarification, it is understood that the objective, nature,
12
scope, and duration of such clinical study will depend on FDA feedback,
LICENSOR's clinical experience, desired endpoints, and/or product labeling at
the time the study commences.
Section 5.02. Introducer 510(k) Submission Timeframe: If, within
twenty-four (24) months after obtaining 510(k) clearance to market a LICENSED
PRODUCT which is a central venous catheter, XXXXXX fails to submit a request for
510(k) clearance for a LICENSED PRODUCT which is an introducer, LICENSOR may
terminate this Agreement with respect to introducers.
Section 5.03. Pulmonary Artery Catheter 510(k) Submission Timeframe:
(a) If, within twenty-four (24) months after obtaining 510(k) clearance
to market a LICENSED PRODUCT which is a central venous catheter, XXXXXX fails to
submit a request for 510(k) clearance for a LICENSED PRODUCT which is a
pulmonary artery catheter, LICENSOR may convert the exclusive license for
pulmonary artery catheters hereunder to a non-exclusive license.
(b) If, within thirty-six (36) months after obtaining 510(k) clearance
to market a LICENSED PRODUCT which is a central venous catheter, XXXXXX fails to
submit a request for 510(k) clearance for a LICENSED PRODUCT which is a
pulmonary artery catheter, LICENSOR may terminate this Agreement with respect to
pulmonary artery catheters.
Section 5.04. Royalty Rate for Non-Exclusive License. If the exclusive
license for a LICENSED PRODUCT is to a non-exclusive license pursuant to
Sections 5.01 and 5.03, then the royalty payments due for such LICENSED PRODUCT
pursuant to Section 3.02 will be halved.
Section 5.05 Delays. The timeframes set forth in Sections 5.01, 5.02
and 5.03 will be extended if delays in meeting the timeframes are caused by
circumstances beyond the control of XXXXXX including, but not limited to, delays
in the development or supply of LICENSOR of COMPOUND meeting SPECIFICATIONS,
delays in establishing safety of COMPOUND or delays in establishing a Master
File in accordance with Section 6.02 below. The timeframes will be extended by
the same amount of time as the delay. For purposes of clarification, the
timeframes in Sections 5.01(a) and (b) above already anticipate that the FDA may
require a clinical study involving 100-200 patients with respect to a short-term
central venous catheter, and that the timeframe for the development and supply
of COMPOUND meeting the SPECIFICATIONS shall be nine (9) months from the
EFFECTIVE DATE. In meeting the timeframes set forth in Sections 5.01, 5.02 and
5.03, XXXXXX agrees to direct its efforts towards catheter extrusion,
development and commercialization. LICENSOR agrees to provide such technical
assistance and support to insure that COMPOUNDS are made to the SPECIFICATIONS
and can be successfully processed into LICENSED PRODUCTS.
13
Section 5.06. Non-Competing. During the first five (5) years following
FIRST COMMERCIAL SALE, the Xxxxxxx Critical-Care division of Xxxxxx Healthcare
Corporation shall not engage in, directly or indirectly, the commercial
production, distribution or sale of any products which directly compete with and
substitute for the LICENSED PRODUCTS unless such other products offer improved
clinical advantages to the LICENSED PRODUCTS. XXXXXX'x existing products with
biocompatibility coatings, where such coatings have inherent anti-microbial
properties, shall not be deemed competitive with LICENSED PRODUCTS for the
purposes of this Section 5.06.
ARTICLE VI. LICENSOR's Other Obligations
Section 6.01 Inventory. Until such time as the TECHNICAL KNOW-HOW
transfer described in Section 4.02 above is completed, LICENSOR shall always
maintain a ninety (90) day supply of the COMPOUND, based on XXXXXX'x forecasted
sales. When such transfer is completed in accordance with Section 4.02 above,
XXXXXX shall purchase all COMPOUND which meets the SPECIFICATIONS and which is
then in LICENSOR's inventory which has been maintained by LICENSOR pursuant to
this Section.
Section 6.02 Master File. LICENSOR shall use its best efforts to create
an FDA Master File containing all information (including without limitation
information provided by XXXXXX to LICENSOR for this purpose) necessary to
support the claims of in vitro reduced colonization and anti-microbial activity
and which is relevant to, or which is useful in obtaining, regulatory clearance
of LICENSED PRODUCTS, including but not limited to biocompatibility data,
results of clinical studies, composition of the COMPOUND, anti-microbial and
anti-colonization in vitro and in vivo testing. LICENSOR and XXXXXX shall work
together to define and establish which information shall be included in this FDA
Master File. Notwithstanding the above, LICENSOR does not guarantee that the FDA
Master File shall be sufficient to obtain FDA allowance of any such claims.
However, LICENSOR is committed to updating and maintaining the FDA Master File
with respect to responses to FDA requests and the availability of additional
data.
ARTICLE VII. Mutual Obligations
Section 7.01. Sharing of Information. Each party shall provide to the
other party all information within its possession concerning biocompatibility
data, results of clinical studies, in vitro testing, in vivo testing, and status
of its pending FDA submissions which are relevant to LICENSED PRODUCTS.
Section 7.02. Disclosure of LICENSOR INVENTIONS and XXXXXX INVENTIONS.
LICENSOR and XXXXXX shall each disclose to the other party LICENSOR INVENTIONS
and XXXXXX INVENTIONS, respectively, at semi-annual meetings to be held by the
parties.
14
Section 7.03. Publicity. Neither party shall issue any press release
nor otherwise publicize the execution of this Agreement or the transactions
contemplated hereunder without the other party's prior written consent, except
to the extent required by federal securities regulations or other applicable
laws.
Section 7.04 Adjusting Deadlines for FDA Filings.
(a) If the FDA requires Pre-Market Approval for any COVERED DEVICE,
then the parties shall negotiate in good faith to adjust the schedules for FDA
submissions in Sections 5.01, 5.02 and 5.03 above.
(b) If, before granting marketing clearance of introducers or pulmonary
artery catheters, the FDA requires clinical studies for demonstrating
anti-microbial effectiveness of the OLIGON TECHNOLOGY on such LICENSED PRODUCTS,
then the parties shall negotiate in good faith to adjust the schedules for FDA
submissions in Section 5.02 and 5.03 above, respectively.
ARTICLE VIII. Representations and Warranties
Section 8.01. LICENSOR's Representations. LICENSOR represents and
warrants that it is the sole and exclusive owner of the entire right, title, and
interest in and to the LICENSED PATENTS on LICENSOR INVENTIONS and is the owner
of the right, title, and interest in and to the TECHNICAL KNOW-HOW and that it
has the right to grant the rights and license hereby granted to XXXXXX. To the
best of LICENSOR's information and belief as of the EFFECTIVE DATE, practice of
the LICENSED PATENTS on COVERED DEVICES does not infringe on the intellecutal
property rights of any third parties.
Section 8.02. Mutual Representations and Warranties. LICENSOR and
XXXXXX each represent and warrant to the other that they have full power and
authority to enter into this Agreement and carry out the transactions
contemplated hereby and that all necessary corporate action has been duly taken
in this regard.
ARTICLE IX. Patenting and Maintenance
Section 9.01. Patent Prosecution of LICENSOR INVENTIONS. LICENSOR shall
have the right to, at its own expense, file and prosecute patent applications on
LICENSOR INVENTIONS and maintain LICENSED PATENTS issuing therefrom; provided,
however, for each LICENSOR INVENTION selected by LICENSOR for filing and
prosecution, LICENSOR shall file and prosecute patent applications in at least
each of the countries listed in Appendix E hereto. XXXXXX shall have the right
to review and comment on all such patent applications and any documents relating
to the prosecution thereof, and agrees to provide full assistance in their
preparation and prosecution. If LICENSOR chooses not to file, prosecute, or
maintain such patent applications or LICENSED PATENTS in any such country for
which XXXXXX desires to
15
seek or maintain patent protection, XXXXXX shall have the right to file such
patent application in LICENSOR's names in any such country at XXXXXX'x own
expense or maintain such LICENSED PATENTS; provided, however, in the event a
LICENSED PATENT is issued in any such country as the result of such patent
application, then (i) LICENSOR shall own such LICENSED PATENT; and (ii) XXXXXX
may deduct its reasonable expenses incurred in obtaining and/or maintaining such
LICENSED PATENT from royalties (including minimum royalties) payable to LICENSOR
in accordance with Sections 3.02 and 3.03 above on LICENSED PRODUCTS
manufactured or sold in such country which is covered by such LICENSED PATENT.
LICENSOR shall have the right to review all such patent applications filed or
prosecuted by XXXXXX and any documents relating to prosecution thereof.
Section 9.02 Patent Prosecution of JOINT INVENTIONS. LICENSOR shall
have the right to file and prosecute patent applications on JOINT INVENTIONS and
maintain LICENSED PATENTS issuing therefrom; provided, however, for each JOINT
INVENTION selected by LICENSOR for filing and prosecution, LICENSOR shall file
and prosecute patent applications in at least each of the countries listed in
Appendix E herein. XXXXXX shall have the right to review and comment on all such
patent applications and any documents relating to the prosecution therof, and
agrees to provide full assistance in their preparation and prosecution. If
LICENSOR chooses not to file, prosecute, or maintain such patent applications or
LICENSED PATENTS in any country for which XXXXXX desires to seek or maintain
patent protection, XXXXXX shall have the right to file such patent application
in XXXXXX'x and LICENSOR's names in any such country or maintain such LICENSED
PATENTS. LICENSOR shall have the right to review all such patent applications
filed, prosecuted and/or maintained by XXXXXX and any documents relating to the
prosecution thereof. Regardless of which party files and prosecutes a patent
application on a JOINT INVENTION, LICENSOR and XXXXXX shall share equally any
reasonable expenses incurred in connection with such filings and prosecutions,
and in the event a patent is issued on such JOINT INVENTION, then (i) XXXXXX and
LICENSOR shall jointly own such patent; (ii) such patent shall be included in
LICENSED PATENTS (including without limitation all exclusivity of rights
pursuant to Section 2.01(a) above); and (iii) XXXXXX shall license such patent
on exclusive, royalty-free basis to LICENSOR to make, have made, use and sell
products other than COVERED DEVICES during the term of this Agreement.
Section 9.03. Cooperation in Patent Prosection. Each party agrees to
make available to the other party, data, records, samples or the like in its
possession or under its control which are required for the preparation,
prosecution, maintenance or defense of any LICENSED PATENT, patent issued with
respect to a XXXXXX INVENTION or application therefor, and that it will sign
oaths, affidavits or other documents as may be required for the preparation,
prosecution, maintenance or defense of such LICENSED PATENTS, patents or
applications.
ARTICLE X. Patent Infringement
Section 10.01. Infringement of Third Party Patents. XXXXXX shall give
LICENSOR prompt notice of each claim or allegation that the manufacture, use or
sale of LICENSED
16
PRODUCTS constitutes an infringement of a patent or patents owned by others.
XXXXXX shall defend, at XXXXXX'x own expense, any suit brought by such other
party against XXXXXX and shall have the right to deduct from royalties
(including minimum royalties) payable to LICENSOR in accordance with Sections
3.02 and 3.03 above its reasonable costs of defending each such claim or
allegation; provided, however, that in no event may LICENSOR's royalties be
reduced by more than fifty percent (50%) of the royalties otherwise payable
hereunder on any royalty payment date. XXXXXX shall submit written reports
showing royalties accruing to LICENSOR and its deductions therefrom.
Notwithstanding anything contained in this Section 10.01 to the contrary, this
Section shall apply only when the claim or allegation arises from XXXXXX'X
practice or use of the LICENSED PATENTS and/or TECHNICAL KNOW-HOW.
Section 10.02. Settlement or Satisfying of Claim. If settling or
satisfying of any claim or allegation of patent infringement described in
Section 10.01 above requires the payment by XXXXXX to a third party of royalties
and/or other amounts for the manufacture, use or sale of LICENSED PRODUCTS,
XXXXXX shall be entitled to deduct those royalties and/or other amounts paid to
such third party from the royalties (including minimum royalties) payable to
LICENSOR in accordance with Sections 3.02 and 3.03 above; provided, however,
that in no event may LICENSOR's royalties be reduced by more than fifty percent
(50%) of the royalties otherwise payable hereunder on any royalty payment date.
Section 10.03. License of Third Party Patents. If XXXXXX and LICENSOR
agree that a license is required from a third party in order for XXXXXX to make,
use and sell LICENSED PRODUCTS without infringing a third party patent and such
license is acquired by XXXXXX. XXXXXX shall be entitled to deduct the royalties
or other amounts payable under said third party license from the royalties
(including minimum royalties) payable to LICENSOR in accordance with Sections
3.02 and 3.03 above; provided, however, that in no event may LICENSOR's
royalties be reduced by more than fifty percent (50%) of the royalties otherwise
payable hereunder on any royalty payment date.
Section 10.04. Exclusive Remedy for Infringement. Sections 10.01, 10.02
and 10.03 are XXXXXX'x sole and exclusive remedies in the event that the
manufacture, use or sale of LICENSED PRODUCTS constitutes an infringement of a
patent or patents owned by others, unless LICENSOR breaches its representations
in Section 8.01 above.
Section 10.05. Infringement of LICENSED PATENTS by Third Parties.
(a) LICENSOR may, but is not required to, take any and all
actions, legal or otherwise, which are necessary to: (i) terminate infringements
of any part of the LICENSED PATENTS in the FIELD OF TECHNOLOGY; or (ii)
terminate any attempted passing-off by imitation of any LICENSED PRODUCT,
including without limitation obtaining damages, injunction and all other
appropriate relief. XXXXXX shall have the right to be kept informed of the
status and progress of all actions instituted by LICENSOR pursuant to this
Section 10.05(a).
17
LICENSOR shall bear all the expenses of all actions which it initiates pursuant
to this Section 10.05(a).
(b) If LICENSOR does not institute an action within sixty
(60) days after receiving notice from XXXXXX of an infringement of any part of
the LICENSED PATENTS in the FIELD OF TECHNOLOGY or of an attempted passing-off
by imitation of any LICENSED PRODUCT, then XXXXXX may institute an action with
respect thereto. LICENSOR shall have the right to be kept informed of the status
and progress of all such actions instituted by XXXXXX pursuant to this Section
10.05(b). XXXXXX shall bear all the expenses of all actions which XXXXXX
initiates pursuant to this Section 10.05(b).
(c) Any recoveries or settlement fees received from suits or
settlements involving an action initiated pursuant to Section 10.05(a) or (b)
above or agreed to shall be paid: (i) first, to the party which initiated such
action, as reimbursement for the expenses of such action (including without
limitation attorneys' fees) which it incurred; (ii) second, to the
non-initiating party, as reimbursement for their expenses incurred in connection
with such action (including without limitation attorneys' fees); and (iii) the
balance (if any) to the party which initiated such action, for such party's own
use and benefit.
(d) Notwithstanding Sections 10.05(a), (b) and (c) above,
LICENSOR and XXXXXX may agree to jointly institute an action in order to (i)
terminate infringements of any part of the LICENSED PATENTS in the FIELD OF
TECHNOLOGY; or (ii) terminate any attempted passing-off by imitation of any
LICENSED PRODUCT. LICENSOR and XXXXXX shall share the expenses of all actions
which they initiate pursuant to this Section 10.05(d) and the proceeds of any
judgment rendered therein or settlement resulting therefrom, pursuant to their
written agreement.
(e) Where, in the judgment of the party initiating an action
under this Section 10.05, it is necessary to use the other party's name to
prosecute such action, such other party agrees to allow the initiating party to
so use the name of such other party; provided, however, that the initiating
party agrees to hold such other party harmless against any award of court costs
or damages resulting solely from the use of such other party's name by the
initiating party in such action.
(f) During the term of this Agreement, LICENSOR shall not have
the power to accept or enter into any settlement agreement in any country
settling any claim of infringement of LICENSED PATENTS in the FIELD OF
TECHNOLOGY by any third party without XXXXXX'x written consent; provided,
however, that if XXXXXX does not give its consent, then thereafter XXXXXX shall
bear all of the costs incurred in connection with pursuing such claim.
18
ARTICLE XI. Sublicensing
XXXXXX may grant sublicenses of the TECHNICAL KNOW-HOW and LICENSED PATENTS to:
(a) AFFILIATES, without LICENSOR's prior consent but with written notice to
LICENSOR: (b) unaffiliated third parties for sale only to XXXXXX and its
AFFILIATES, subject to LICENSOR's prior written consent, which consent shall not
be unreasonably withheld; or (c) any other unaffiliated third parties, subject
to LICENSOR's prior written consent, which consent may be withheld in LICENSOR's
sole and absolute discretion. Said sublicenses shall be subject to the terms of
this Agreement, provided, however, that with respect to sublicenses to make, use
and sell LICENSED PRODUCTS granted to third parties which are not AFFILIATES,
XXXXXX agrees to share with LICENSOR any royalties and other amounts received
from third parties in the ratio of sixty percent (60%) to XXXXXX and forty
percent (40%) to LICENSOR, so long as LICENSOR is paid an amount for each unit
of LICENSED PRODUCT which is no less than the applicable royalty under Section
3.02 above.
ARTICLE XII. Term and Termination
Section 12.01. Term of the Agreement. Unless sooner terminated as
otherwise provided herein, this Agreement shall expire on the first date on
which XXXXXX'x royalty payment obligations have ended with respect to all
LICENSED PRODUCTS in all countries. After such expiration date, XXXXXX shall
have: (a) a fully paid-up license to use the LICENSED PATENTS and the TECHNICAL
KNOW-HOW in the FIELD OF TECHNOLOGY; and (b) a royalty-free license to use the
OLIGON TRADEMARKS in accordance with Section 2.02 above.
Section 12.02. Termination by LICENSOR -- Default. Should XXXXXX fail
to perform any covenant of this Agreement on its part to be performed, then upon
written notice of such failure from LICENSOR, XXXXXX shall have thirty (30) days
from the date of such notice to correct a breach which relates to the timely
payment of funds to LICENSOR and shall have ninety (90) days from the date of
such notice to correct any other breach. Upon the failure of XXXXXX to correct
such breach, and upon thirty (30) days further written notice, LICENSOR may
cancel and terminate this Agreement.
Section 12.03. Termination by XXXXXX. XXXXXX may terminate this
Agreement for any reason upon twelve (12) months prior written notice to
LICENSOR.
Section 12.04. Rights After Termination.
(a) The parties hereto agree that, if this Agreement is
terminated prior to its expiration, XXXXXX shall immediately cease: (i) any use
or practice of the LICENSED PATENTS, TECHNICAL KNOW-HOW and OLIGON TRADEMARKS;
and (ii) any making, use or sale of the LICENSED PRODUCTS; provided, however,
that XXXXXX shall have the right to complete manufacture of LICENSED PRODUCTS
which constitute work in progress as of the date of termination or expiration
and to sell such LICENSED PRODUCTS, subject to
19
XXXXXX'x royalty payment obligations under Section 3.02 above. Each party to
this Agreement shall, at its own expense, return to the other party all
CONFIDENTIAL INFORMATION provided by such other party as soon as practicable
after the date of such termination or expiration and any copies thereof, which
have been received or derived by such party. During the term of this Agreement
and thereafter, all such CONFIDENTIAL INFORMATION shall remain the exclusive
property of the party which provided it.
(b) No termination of this Agreement shall affect the rights
of LICENSOR to royalties due and owing and to statements of account to and
including the date of termination.
ARTICLE XIII. Miscellaneous
Section 13.01. Most Favored Licensee. LICENSOR agrees that in the event
this license becomes nonexclusive, and LICENSOR thereafter enters into any
license agreement with a third party in the FIELD OF TECHNOLOGY providing for a
lower or more advantageous royalty rate, transfer price for COMPOUND or for any
other terms or conditions more favorable to the licensee than herein set forth,
then and thereafter, XXXXXX shall have the benefit of such lower or more
favorable royalty rate, transfer price for COMPOUND, terms or conditions.
SectION 13.02. Assignability. This Agreement, or any of the rights or
obligations created herein, may be assigned, in whole or in part, by either
party to (l) any person or entity controlling, controlled by or under common
control with such party, or (2) a purchaser of all or substantially all of the
assets of such party relating to the LICENSED PRODUCTS. Otherwise, this
Agreement, or any of the rights or obligations created herein, may not be
assigned, in whole or in part, by either party without the written consent of
the other party, except that LICENSOR may, without the consent of XXXXXX,
assign its right to receive payments under this Agreement to any person or
entity.
Section 13.03. Force Majeure. If either party fails to fulfill its
obligations hereunder (other than payment obligations) when such failure is due
to a cause beyond its control, including an act of nature, or other action such
as fire, flood, civil commotion, riot, war (declared and undeclared),
revolution, action by government including delays in obtaining government
approvals, embargoes, then said failure shall be excused for the duration of
said event.
Section 13.04. Notice. Any notice or communication required or
permitted to be given by either party hereunder shall be deemed sufficiently
given, if mailed by registered or certified mail and addressed to the party to
whom notice is given as follows:
IF TO BAXTER TO:
XXXXXX HEALTHCARE CORPORATION
Xxxxxxx Critical-Care Division
00000 Xxxxxxx Xxxxxx
00
Xxxxxx, Xxxxxxxxxx 00000
ATTN: President
IF TO LICENSOR TO:
IMPLEMED, INC.
000 Xxxxxxxx xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
ATTN: President
with a copy to:
Xxxxx Xxxxxxx, Esq.
Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Section 13.05. Governing Law. This Agreement shall be interpreted in
accordance with the laws of the State of California, excluding its conflicts of
laws principles and the United Nations Convention on Contracts for the
International Sale of Goods.
Section 13.06. Complete Agreement. As of its effective date, this
Agreement represents the entire agreement between the parties hereto with
respect to the subject matter hereof. There are no understandings,
representations or warranties of any kind except as expressly set forth herein.
This Agreement supersedes the Confidential Disclosure Agreement between the
parties dated April 1, 1996.
Section 13.07. Severability. If any of the provisions of this Agreement
are held void or unenforceable, the remaining provisions shall nevertheless be
effective, the intent being to effectuate this Agreement to the fullest extent
possible.
Section 13.08. Modification. Any modification of this agreement shall
be in writing and shall be signed by both XXXXXX and LICENSOR. Any attempt to
modify this Agreement orally or in writing not executed by all parties hereto
shall be void.
Section 13.09. Confidentiality. XXXXXX and LICENSOR realize that some
information received by one party from the other pursuant to this Agreement will
be confidential. It is therefore agreed that any information received by one
party from the other which is in writing, or reduced to writing within thirty
(30) days of the date of disclosure, and clearly designated as "CONFIDENTIAL,"
shall not during or after the term of this Agreement be (i) disclosed by the
receiving party to any third party, except to the extent that (A) such third
party has agreed in writing to abide to these confidentiality obligations and
(B) such third party has a need to know such information in order to manufacture
the COMPOUND on behalf of XXXXXX or its
21
AFFILIATES for use in COVERED DEVICES, or (ii) used by the receiving party for
purposes other than those contemplated by this Agreement.
However, nothing in this Agreement shall prevent the receiving party
from disclosing any such information --
(a) which is or becomes publicly known through no fault of the
receiving party;
(b) which the receiving party rightfully had in its possession prior to
the disclosure to the receiving party, as evidenced by written documentation;
(c) which the receiving party lawfully obtained without restriction
from a third party with no secrecy or confidentiality obligation to the
disclosing party.
(d) which is approved in writing by the disclosing party for disclosure
by the receiving party; or
(e) which is disclosed pursuant to court order or as otherwise
completed by law.
Section 13.10. Limits of Liability. NEITHER PARTY SHALL BE LIABLE TO
THE OTHER UNDER ANY SECTION OF THIS AGREEMENT OR UNDER ANY CONTRACT. NEGLIGENCE,
STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY AMOUNT IN EXCESS OF
THE AGGREGATE OF THE AGREED UPON AMOUNTS TO BE PAID TO LICENSOR UNDER THIS
AGREEMENT PRIOR TO THE DATE THE CAUSE OF ACTION AROSE, OR FOR ANY SPECIAL,
INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES, LOST PROFITS, LOST DATE OR COST
OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES. IN ADDITION, XXXXXX
SHALL INDEMNIFY AND HOLD LICENSOR HARMLESS IN THE EVENT ANY CLAIM OR ALLEGATION
IS BROUGHT AGAINST LICENSOR ARISING FROM DEATH OR INJURY CAUSED BY A LICENSED
PRODUCT, EXCEPT WHERE THE CLAIM OR ALLEGATION IS DIRECTLY ATTRIBUTABLE TO
COMPOUND PROVIDED BY LICENSOR AND INCORPORATED INTO SUCH LICENSED PRODUCT, WHICH
COMPOUND FAILS TO SATISFY THE SPECIFICATIONS.
Section 13.11. Survival. Notwithstanding anything else in this
Agreement to the contrary, the parties agree that Sections 2.03, 3.07, 3.08,
3.09, 9.01, 9.02, 9.03, 10.01, 10.02, 10.03, 10.04, 10.05(c) and (d), 12.04,
13.04 through 13.07 and 13.09 through 13.14 shall survive the termination or
expiration of this agreement, as the case may be. In addition, Section 12.01
shall survive the expiration of this Agreement.
Section 13.12. Headings. Any headings contained herein are for
directory purposes only, do not constitute a part of this Agreement, and shall
not be employed in interpreting this Agreement.
22
Section 13.13. Waiver. A waiver of any breach of any provision of this
Agreement shall not be construed as a continuing waiver of other breaches of the
same or other provisions of this Agreement.
Section 13.14 Relationship of the Parties. The parties hereto are
independent contractors. Nothing herein contained shall be deemed to create a
joint venture, agency or partnership relationship between the parties hereto.
Neither party shall have any power to enter into any contracts or commitments in
the name of, or on behalf of, the other party, or to bind the other party in any
respect whatsoever.
IN WITNESS THEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the day and year first
above written.
IMPLEMED, INC. XXXXXX HEALTHCARE CORPORATION
Xxxxxxx Critical-Care Division
By: 7 May 97 By: /s/
------------------------- -----------------------------
Date: Date: 6 MAY 97
------------------------ ----------------------------
Appendix A Licensed Patents
Appendix B Compound Specifications
Appendix C Oligon Trademarks and Quality Control Standards
Appendix D Technology Transfer Procedures
Appendix E Countries for Seeking Patent Protection
Appendix F Description of 7F, 3 Lumen Catheter Set
23
