Exhibit 10.75
LICENSE AGREEMENT
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This Agreement, effective as of the 12th day of March, 2000
(hereinafter "EFFECTIVE DATE") by and between The Med-Design Corporation, a
corporation of the State of California, having an address at 0000 Xxxxxx Xxxxxx,
Xxxxxxx, Xxxxxxxxxx 00000 (hereinafter referred to as "LICENSOR") and Becton,
Xxxxxxxxx and Company, a corporation of the State of New Jersey, having a place
of business at 0 Xxxxxx Xxxxx, Xxxxxxxx Xxxxx, Xxx Xxxxxx 00000-0000
(hereinafter referred to as "BD").
WITNESSETH:
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WHEREAS, LICENSOR represents and warrants that it is the sole and
exclusive owner of the entire right, title and interest in and to certain
inventions relating to retracting needle hypodermic syringes as described and
claimed in patents and patent applications including, U.S. Patent Nos. 4,994,034
to Xxxxxx and 5,188,599 to Xxxxxx and U.S. patent application, Serial No.
60/169,430 filed December 7, 1999, entitled "Medical Device with Safety Needle"
and other patents or patent applications listed in Attachment A appended to and
made part of this Agreement;
WHEREAS, LICENSOR represents and warrants that it has a licensable
interest in U.S. Patent No. 4,838,869 to Xxxxxx, and U.S. Patent No. 4,927,414
to Kulli.
WHEREAS, LICENSOR represents and warrants that it has the right to
grant the license as set forth in this Agreement and is able to enter into this
Agreement and become bound by the terms hereof;
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
WHEREAS, BD desires to obtain from LICENSOR an exclusive license under
all retracting needle hypodermic syringe patent rights and know-how owned by
LICENSOR or in which LICENSOR has a licensable interest, including but not
limited to the patents and patent applications listed in APPENDIX A, and
LICENSOR is willing to grant such a license to BD under the terms and conditions
set forth herein.
NOW, THEREFORE, for and in consideration of the premises and the mutual
promises and covenants herein contained, and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereto agree as follows:
ARTICLE I - DEFINITIONS
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1. "AFFILIATE(S)" as used herein shall mean an entity which directly or
indirectly, through one or more intermediaries, controls BD, is controlled by
BD, or is under the common control of BD.
2. As used herein, "BD" shall include Becton, Xxxxxxxxx and Company and
its subsidiaries and AFFILIATES.
3. "FIELD" as used herein shall mean hypodermic syringes and retracting
or needle covering assemblies connectable to or as part of a hypodermic syringe,
specifically including all sizes of and uses for a syringe including insulin and
tuberculin syringes and all other syringes not otherwise herein excluded, but
excluding a syringe with a separable fluid container such as a vial, cartridge
or ampoule and further excluding devices used for arterial blood sampling, blood
donor needles, AV fistula needles, spinal/epidural needles, and guide wire
introducers.
4. "RETRACTING HYPODERMIC SYRINGE" as used herein shall mean
spring-based retracting hypodermic devices for use with or as a part of a
hypodermic syringe.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
5. "KNOW-HOW" as used herein shall mean technical data, designs, plans,
specifications, methods, processes, systems, clinical data and other information
or documentation, whether patentable or not, relating to RETRACTING HYPODERMIC
SYRINGES, their manufacture or use and known, owned or controlled by LICENSOR,
or to which LICENSOR has a licensable interest during the life of this
Agreement.
6. "LICENSED PATENT RIGHTS" as used herein shall mean those United
States and foreign patents and/or patent applications listed in Appendix A of
this Agreement, any continuations, continuations-in-part, divisions, extensions,
substitutions, reissues or re-examinations thereof; and any subsequently filed
patent applications, and any patents issuing therefrom owned by or assigned to
LICENSOR, or in which LICENSOR has a licensable interest, which claim products
in the FIELD.
7. "VALID CLAIM" as used herein shall mean a claim of an issued or
granted patent within LICENSED PATENT RIGHTS so long as such claim shall not
have been disclaimed by LICENSOR, or shall not have been held invalid by a court
of competent jurisdiction in an unappealed or unappealable final decision.
8. "PATENTED PRODUCTS" as used herein shall mean any product whose
manufacture, use, importation, offer for sale or sale by BD or purchased by or
from BD would, but for this License Agreement, in a jurisdiction where a VALID
CLAIM exists, infringe such a VALID CLAIM.
9. "UNPATENTED RETRACTING HYPODERMIC PRODUCT(S)" as used herein shall
mean any RETRACTING HYPODERMIC SYRINGE (excluding needle covering assemblies) in
the FIELD which is not a PATENTED PRODUCT. Accordingly, a RETRACTING HYPODERMIC
SYRINGE that falls within the definition of a PATENTED PRODUCT, when made or
sold in a country where a VALID CLAIM exists, will be considered an UNPATENTED
RETRACTING HYPODERMIC PRODUCT when it is both made and sold in countries where
no VALID CLAIM exists.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
10. "PRODUCT(S)" as used herein shall mean PATENTED PRODUCTS and/or
UNPATENTED RETRACTING HYPODERMIC PRODUCT(S).
11. "NET SALES" as used herein shall, unless otherwise provided, mean
the price at which PRODUCTS are sold by BD or a party sublicensed by BD, to a
purchaser other than BD, either individually or as part of a kit, less returns,
allowances or credits, rebates, excise, sale, use or value-added taxes, delivery
charges billed on the invoice to the purchaser, cash and trade discounts
allowed, import duty and commissions to agents. Rebates and allowances as used
herein shall not include costs of goods sold or marketing expenses and shall be
those exclusively attributable to the PRODUCTS.
12. "IMPROVEMENT" as used herein shall mean any modification of a
PRODUCT for use in the FIELD.
ARTICLE II - GRANT
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1. Subject to the terms and conditions of this Agreement, LICENSOR
hereby grants to BD, an exclusive world-wide right and license under the
LICENSED PATENT RIGHTS to make, have made, use, import, offer to sell and sell
PATENTED PRODUCTS in the FIELD together with the right to grant sublicenses.
LICENSOR also grants to BD an exclusive world-wide right and license under the
KNOW-HOW to make, have made, use, import, offer to sell and sell PRODUCTS in the
FIELD.
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confidential treatment that has been filed with the Commission. The omitted
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2. All IMPROVEMENTS, conceived, developed or acquired by LICENSOR
during the term of this Agreement shall automatically become part of the rights
granted to BD under Paragraph 1 of this Article and shall be promptly disclosed
to BD.
ARTICLE III - PAYMENTS
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1. BD shall pay LICENSOR a non-refundable, up front payment of Four
Million United States Dollars (U.S. $4,000,000) consisting of Two and One-Half
Million United States Dollars (U.S. $2,500,000) payable within ten (10) days
after the execution of this Agreement and One and One-Half Million United States
Dollars (U.S. $1,500,000) by application of the monies already paid to LICENSOR
through the "Addendum to License Agreement" of December 11, 1999 between
LICENSOR and BD.
2. In addition to the payment recited in Paragraph 1 of this Article:
(A) BD shall pay to LICENSOR, while this Agreement is in effect, an
earned royalty of [**] of NET SALES of PATENTED PRODUCTS sold in the United
States and Canada and an earned royalty of [**] of NET SALES of PATENTED
PRODUCTS sold in countries outside the United States and Canada. If a product is
made or sold in a jurisdiction where a VALID CLAIM exists so that the
manufacture or sale would infringe such VALID CLAIM, but for this License
Agreement, then the product is a PATENTED PRODUCT for purposes of determining
the amount of royalty payment due hereunder.
(B) BD shall pay to LICENSOR a royalty of [**] of NET SALES of
UNPATENTED RETRACTING HYPODERMIC PRODUCTS, whether empty of filled, which are
sold in any country prior to February 29, 2008. Such payment is in lieu of any
minimum royalties.
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confidential treatment that has been filed with the Commission. The omitted
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(C) If BD is not selling PATENTED PRODUCTS on February 29, 2008, BD
will have the sole option to continue to pay a [**] royalty on UNPATENTED
RETRACTING HYPODERMIC PRODUCTS or to cease paying such [**] royalty by giving
notice to LICENSOR, as provided in this paragraph. At any time beginning
December 1, 2007, BD may give notice to LICENSOR that it will cease paying such
[**] royalty. At the time of such notice, if BD is not selling PATENTED PRODUCTS
in any country(s), LICENSOR may convert the license granted herein under
LICENSED PATENT RIGHTS to non-exclusive in such country(s) with BD having no
right thereafter to grant sublicenses. Such notice of ceasing to pay such [**]
royalty shall be given ninety (90) days in advance of BD ceasing to pay such
[**] royalty.
3. BD will make a good faith determination as to whether a product in
the FIELD it sells is a PATENTED PRODUCT, including obtaining an opinion of a
competent patent counsel, and will notify LICENSOR of such determination. Such
notification shall not be deemed to waive any privilege that might cover the
opinion or opinions that are obtained by BD to make its determination. Such
determination and notification by BD shall also not be deemed to waive
LICENSOR's right to dispute resolution as provided in Article VIII hereof in the
event of a dispute as to whether such product is a PATENTED PRODUCT; provided
however, LICENSOR must institute dispute resolution contesting such
determination within one (1) year from receipt of such notification from BD or
the commercial release of a PRODUCT whichever is later. Should LICENSOR obtain
additional patent(s) in the FIELD which become the subject of the license
granted to BD herein, BD will make a good faith determination as to whether
products in the FIELD it is selling at the time such patent(s) is issued is a
PATENTED PRODUCT under such additional patent(s) and will notify LICENSOR as
described above. LICENSOR must institute dispute resolution contesting such
determination within one (1) year from receipt of such notification from BD.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
4. In situations where a PRODUCT is sold by BD in combination with
other products not licensed hereunder, such as a kit or package or as part of a
prefilled syringe, the NET SALES on which the royalty rate is applied, shall be
calculated by applying to the NET SALES of the kit or package or prefilled
syringe, a fractional multiplier having as its denominator [**] and as its
numerator [**], if the PRODUCT is sold separately in an arms length transaction
in substantially the same quantity at generally the same time as the transaction
to which this subparagraph relates. If the PRODUCT is not sold separately in
such a transaction, the NET SALES on which the royalty rate is applied shall be
calculated by applying to the NET SALES of the kit or package or prefilled
syringe, a fractional multiplier having as its denominator [**] and as its
numerator [**]. It is understood that in no event shall the NET SALES figure for
the PRODUCT in a kit or package or multiple product contract be less than the
selling price of the PRODUCT, if the PRODUCT is sold separately in an arm's
length transaction in substantially the same quantity at generally the same
time.
5. Royalties are payable by BD under Paragraph 2(A) based solely on
PATENTED PRODUCTS being made, used and/or sold by BD, on a country-by-country
basis, until the LICENSED PATENT RIGHTS on a country-by-country basis expire.
6. At the latest, at the expiration of the last to expire of the
LICENSED PATENT RIGHTS or as otherwise provided in this Agreement, provided BD
is not in breach of this AGREEMENT, BD shall have a completely paid-up,
royalty-free right and license to subsequently make, have made, use, import,
offer to sell, and sell products that were previously PATENTED PRODUCT
throughout the world and shall have no further obligations to LICENSOR.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
7. BD presently intends to release a RETRACTING HYPODERMIC SYRINGE
during the year 2001. If BD does not release for commercial distribution a
RETRACTING HYPODERMIC SYRINGE by June 30, 2002, LICENSOR shall have the right to
give notice to BD that the right and license granted herein is converted to a
non-exclusive license, provided however LICENSOR agrees that it will not
exercise such right as long as BD is proceeding diligently toward releasing a
RETRACTING HYPODERMIC SYRINGE for commercial distribution.
8. If after June 30, 2002, BD exits the market for RETRACTING
HYPODERMIC SYRINGES so that BD's sales of PRODUCTS in 2004 and each subsequent
year of this Agreement generate royalties to LICENSOR less than [**] annually,
BD will have the right to pay the difference to LICENSOR so that the LICENSOR
receives [**] each year. If BD does not pay this difference in any of these
years, LICENSOR will have the right to convert the license granted herein to a
non-exclusive license with no right thereafter to grant sublicenses.
9. Payments by BD to LICENSOR under this Agreement are considered to be
complete satisfaction of any duty imposed upon BD to commercially exploit the
PRODUCTS and are accepted by LICENSOR in lieu of any best efforts, reasonable
efforts or other performance obligations on the part of BD.
10. Nothing herein contained shall in any way limit BD's free and
exclusive right to determine in its sole discretion the timing or manner of
marketing, manufacturing or advertising the PRODUCT or prevent BD from making,
using or selling or causing to be made, have made, used or sold any place in the
world product competitive in nature to PRODUCTS.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
ARTICLE IV - PATENT PROSECUTION AND MAINTENANCE
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AND GOVERNMENT CLEARANCES
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1. In LICENSOR'S sole discretion, LICENSOR shall be responsible for
filing and prosecuting patent applications and shall carry the expense of
prosecuting and maintaining all patents granted and patent applications under
LICENSED PATENT RIGHTS. LICENSOR shall keep BD informed with alacrity of the
filing and progress of material aspects of the prosecution of all such
applications and of the issuance of patents, and may consult with BD concerning
any decisions which would affect the scope of any issued claims and other
prosecutorial details, including the potential abandonment of any application.
LICENSOR shall notify BD of any additions, deletions or changes in the status of
patents and/or applications listed in Appendix A.
2. LICENSOR may, at its sole discretion, elect to abandon any
application or patent, and will give BD written notice thereof. If BD requests,
LICENSOR will assign such application or patent to BD, provided BD shall pay to
LICENSOR a mutually agreed upon fee for such application or patent. Upon
assignment to BD, such application or patent shall no longer be subject to the
terms of this Agreement.
3. All patent applications filed under LICENSED PATENT RIGHTS and all
patents granted thereon shall be owned by LICENSOR, subject to the license
granted to BD set forth herein.
4. It is understood and agreed that enhancements, modifications or
improvements to PRODUCT(S) may be made by BD during the term of this License
Agreement, and that all rights, title and interest to any of the aforesaid
including any patents issued remain the sole and exclusive property of BD.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
5. BD shall, at its own expense, obtain all necessary clearances from
governmental agencies to market PRODUCT(S). LICENSOR agrees to cooperate with BD
and assist in all reasonable ways in obtaining any such clearances, but at BD's
expense.
ARTICLE V - KNOW-HOW
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1. LICENSOR shall disclose KNOW-HOW to BD and such KNOW-HOW shall be
furnished by LICENSOR to BD on LICENSOR's own volition and/or upon request by BD
to the extent that BD requires same to make, have made, use, offer to sell and
sell the PRODUCT(S).
ARTICLE VI - ADDITIONAL REPRESENTATiONS AND WARRANTIES
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1. LICENSOR represents and warrants that there are Retracting
Hypodermic Syringes for which LICENSOR knows of no patent or patent application
owned by a third party that would be infringed by the making, using, offering
for sale, sale or importing of such Retracting Hypodermic Syringes under
PATENTED PRODUCTS in the FIELD.
2. LICENSOR represents and warrants that it has not received any
notice, whether written or oral, that any PATENTED PRODUCTS in the FIELD
infringe any patents or patent applications of a third party.
3. LICENSOR represents and warrants that it is under no obligation to
any third party that would interfere with its representations or obligations
under this Agreement.
4. LICENSOR represents and warrants that there are no encumbrances,
liens or security interests involving LICENSED PATENT RIGHTS.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
5. LICENSOR represents and warrants that all approvals needed by it to
enter this Agreement have been obtained.
6. LICENSOR represents and warrants that, to the extent it has
licensable rights in U.S. Patent No. 4,900,307 to Kulli, it will not practice
under or license any such rights to a third party in the FIELD while the license
hereunder is exclusive.
7. BD represents and warrants that it is able to enter into this
Agreement and become bound by the terms hereof.
8. BD represents and warrants that all approvals needed by it to enter
this Agreement have been obtained.
ARTICLE VII - BOOKS OF ACCOUNT AND REPORTS
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1. BD agrees to keep complete and accurate records of its sales of the
PRODUCT(S) sold and all data necessary for the computation of payments to be
made to LICENSOR hereunder. However, BD shall have no duty of trust or other
fiduciary relationship with LICENSOR regarding the maintenance of the books of
account or the calculation and reporting of royalties.
2. Payments under ARTICLE III, when due, shall be made on or before the
last business day of June, September, December and March of each year for the
PRODUCT(S) sold by BD during the preceding quarterly periods ending on the last
day of March, June, September and December, respectively. Such payments to
LICENSOR shall be accompanied by a statement showing the total NET SALES of the
PRODUCT(S) sold by BD, and such other particulars as are necessary for an
accurate accounting of the payments made pursuant to this Agreement. Payment of
the amount due shall accompany such statement, which shall be deemed to be true
and correct unless objected to and audited in accordance with Paragraph 4 of
this ARTICLE.
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3. (A) To the extent sales requiring a royalty payment may have been
made by BD in a country other than the United States, such royalty payments
shall be made by BD in United States dollars on the basis of conversion, from
the currency of such other country, at the rate of exchange recited in the
report entitled "Rates of Exchange" issued monthly by BD's International Finance
Department which provides spot exchange rates for each country where sales were
made, on the last business day of the calendar quarter in which the sales
occurred, and shall be paid at the time and in the manner set forth above,
provided however, that royalties based on sales in any country shall be payable
to LICENSOR only after deducting for exchange and all other charges due to other
governments due to royalties, including withholding taxes due to royalties,
resulting in foreign tax credits to LICENSOR, arising from the origin and
transmittal of such royalties. BD agrees to accompany the statements to LICENSOR
under paragraph 2 with copies of the "Rates of Exchange" reports used in
calculating exchange rates for royalties in regard to countries outside the
United States.
(B) The foregoing is subject to the right of BD to make payment of
royalties in any country where withdrawal of the currency from the country is
blocked and where legal conversion of the currency billed cannot be made into
United States dollars, whereupon BD shall make the payment by depositing such
royalty payments in LICENSOR's name in a bank designated by LICENSOR within such
country.
4. LICENSOR, at its own expense, shall have the right for a period of
three (3) years after receiving any report from BD to nominate an independent
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confidential treatment that has been filed with the Commission. The omitted
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Certified Public Accountant, acceptable to BD, which acceptance shall not be
unreasonably withheld, who shall have access to BD's records during reasonable
business hours for the purpose of verifying the payments made under this
Agreement, but this right may not be exercised more than once in any calendar
year and the Accountant shall disclose to LICENSOR information limited only to
the accuracy of the royalty statements and the payments made in accordance with
the statements under paragraph (2) of this Article, provided however, that if
payments made by BD on the basis of BD's statements are found to be in error by
more than a negative five percent (5%), or fifty thousand dollars ($50,000),
whichever is greater, BD shall bear the cost of the audit. The failure of
LICENSOR to request verification of any payment report during said three (3)
year period shall be considered acceptance of the accuracy of such report,
except if fraudulent reporting is found, then LICENSOR may go back beyond the
three (3) year period to verify all payments under the AGREEMENT, however BD
shall have no obligations to maintain any records pertaining to such report
beyond said three (3) year period.
ARTICLE VIII - DISPUTE RESOLUTION
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1. The parties shall attempt in good faith to resolve any dispute
arising out of or relating to this Agreement including, without limitation,
whether any product of BD should be deemed a PATENTED LICENSED PRODUCT hereunder
or questions relating to breach of this Agreement, promptly by negotiations
between executives who have authority to settle such dispute. Any party may give
the other party written notice of any dispute ("Notice of Dispute") hereunder
not resolved in the normal course of business. Within twenty (20) days following
delivery of such notice, executives of both parties shall discuss by telephone
or meet at a mutually acceptable time and place, and thereafter as often as they
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
reasonably deem necessary, to exchange relevant information and to attempt to
resolve such dispute. If the matter has not been resolved within thirty (30)
days following the Notice of Dispute, and subject to the provisions of Paragraph
3 below, either party may initiate non-binding mediation of the dispute or claim
under the then-current Center for Public Resources Procedure for Mediation of
Business Disputes. All negotiations pursuant to this clause are confidential and
shall be treated as compromise and settlement negotiations for the purposes of
applicable rules of evidence.
2. If a negotiator intends to be accompanied at a telephone conference
or a meeting by their attorney(s), the other negotiator shall be given at least
three (3) business days' notice of such intention and may also be accompanied by
their attorney(s).
3. In the event the parties are unable to resolve any dispute by
negotiations and/or mediation as set forth in Paragraph 1, within sixty (60)
days of the Notice of Dispute, then such dispute shall be submitted to binding
arbitration before a single arbitrator agreeable to both parties or, if no
arbitrator is agreeable to both parties, each party will select an arbitrator,
who is not employed by or a consultant to either party, and the two selected
arbitrators will select a third arbitrator, who is not employed by or a
consultant to either party. The arbitration shall be held in accordance with the
Patent Arbitration Rules of the Center of Public Resources then in effect, or
before any other tribunal acceptable to the parties such as the National Patent
Board constituted to resolve disputes between parties involving intellectual
property matters. Any arbitration or dispute resolution procedure shall be
presented in New York, New York. Arbitration regarding whether BD's products
infringe a claim of a LICENSED PATENT RIGHT or whether a LICENSED PATENT CLAIM
is invalid shall be conducted before an arbitrator(s) experienced in patent law
for determination as to infringement and validity. The presumption of validity
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
will apply in any arbitration. If the arbitrator(s) find that bringing the
arbitration by LICENSOR was not reasonably justified, LICENSOR will pay BD its
reasonable costs including reasonable attorneys' fees expended in the
arbitration. The arbitrator(s) shall make a decision as to the dispute which
shall set forth findings of fact and conclusions of law and such decision shall
be binding as between the parties, shall be final and unappealable, and shall be
binding between the parties in any subsequent action. Any decision by an
arbitrator(s) shall not be binding with respect to any third party in any
subsequent court action. It is further understood that any decision by an
arbitrator(s) shall not be interpreted as an admission against interest of any
party hereto and shall not be admissible as evidence in any subsequent court
action with a third party. The arbitrator(s) is not empowered to award damages
in excess of compensatory damages and each party hereby irrevocably waives any
right to recover such damages with respect to any dispute resolved under this
paragraph.
4. With respect to arbitrated disputes relating to the question of
whether a product is a PATENTED PRODUCT within the terms of this Agreement, if
the arbitrator(s)'s determination is that the product is a PATENTED PRODUCT
within the terms of this Agreement, royalties shall be payable by BD in
accordance with the royalty provisions set forth herein, effective as of the
date BD commenced making, using, having made or selling such PATENTED PRODUCT.
BD shall be entitled to an offset of any royalty it paid on such PATENTED
PRODUCT under paragraph 2(B) of Article III hereof. Each party shall bear its
costs of mediation and arbitration, subject to the foregoing provisions.
5. Each party is required to continue to perform its obligations under
this Agreement pending final resolution of any dispute arising out of or
relating to this Agreement.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
6. No party shall institute any court proceedings regarding any dispute
arising out of or relating to this Agreement, including, without limitation,
proceedings related to a request for equitable relief of any kind, it being
understood that the dispute resolution of this Article is the sole remedy,
unless otherwise provided elsewhere in this Agreement, for resolving disputes
between the parties. Notwithstanding the foregoing, the parties may initiate
court proceedings related to the enforcement of any arbitration award between
the parties.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
ARTICLE IX - PATENT LITIGATION
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1. (A) In the event any party hereto receives notice of alleged
infringement of any LICENSED PATENT RIGHTS in the FIELD, it shall promptly
notify the other party in writing of such infringement. While BD is an exclusive
licensee and paying royalties under paragraph 2(A) of Article III, it shall have
the right, but not the obligation, to bring suit and to control the conduct
thereof against the alleged infringer, and to join LICENSOR as a party to such
suit, in which event BD shall hold LICENSOR free, clear and harmless from any
and all costs and expenses of such litigation, including attorneys' fees. In the
event BD exercises the right to bring suit herein conferred, it shall have the
right to first reimburse itself out of any sums recovered in such suit or in
settlement thereof for all costs and expenses of every kind and character,
including attorneys' fees, and if after such reimbursement, any recovery shall
remain, twenty-five percent (25%) thereof shall be paid to LICENSOR. It is
understood that, if BD brings suit against an infringer as provided herein, and
the assistance of LICENSOR'S employees is required or LICENSOR'S employees are
deposed therein, then BD shall compensate LICENSOR for the reasonable time and
expenses of LICENSOR'S employees except for the actual time such employees are
being deposed as a fact witness, and payment shall be made by BD promptly after
invoiced.
(B) If BD does not bring suit against said infringer, as herein
provided, within one hundred twenty (120) days after receipt of such notice,
LICENSOR shall have the right, but shall not be obligated, to bring suit for
such alleged infringement, and to join BD as a party to such suit only if a
court of competent jurisdiction determines BD is an indispensable party to such
suit, in which event LICENSOR shall hold BD free, clear and harmless from any
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
and all costs and expenses of such litigation, including attorneys' fees. It is
understood that, if LICENSOR brings suit against an infringer as provided
herein, and the assistance of BD's employees is required or BD's employees are
deposed therein, then LICENSOR shall compensate BD for the reasonable time and
expenses of BD's' employees, except for actual time such employees are being
deposed as a fact witness, and payment shall be made by LICENSOR promptly after
invoiced. In the event LICENSOR exercises the right to bring suit for such
alleged infringement, any sums recovered in any suit or settlement shall belong
to LICENSOR. However, after first deducting all costs and expenses of every kind
and character, including attorneys' fees and if after such reimbursement of
Licensor any recovery remains, twenty-five percent (25%) of any such remaining
recovery received by LICENSOR shall be considered as royalty payments as though
paid by BD and shall be credited to BD against earned royalties payable by BD on
PATENTED PRODUCTS.
(C) Any VALID CLAIM held to be invalid or unenforceable by a court
of competent jurisdiction shall be considered canceled from the LICENSED PATENT
RIGHTS effective as of the date BD or the third party receives a final judgment
in such legal action, which is unappealed or unappealable.
(D) Each party shall always have the right to be represented by
counsel of its own selection and at its own expense in any suit instituted by
the other party for infringement, under the terms hereof. Either party has the
right, within ninety (90) days of the filing of the original complaint, to join
in, but not control, any such infringement suit brought by the other party and
shall share equally in the cost and expenses of such litigation, including
attorneys' fees, and any sums recovered.
Page 18
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
2. (A) If BD is sued by a third party in any country charging
infringement of a patent based on a PATENTED PRODUCT, wherein such claim of
infringement is based on a feature or features owned by LICENSOR under the
LICENSED PATENT RIGHTS, and on such feature(s) BD is paying royalties to
LICENSOR under paragraph 2(A) of Article III, BD shall promptly notify LICENSOR.
(B) In the event of (i) a final adjudication in any such suit
enjoining BD from making, using, or selling PATENTED PRODUCTS based solely on
features which make such products PATENTED PRODUCTS or holding BD liable for
damages based on such features or (ii) a settlement of such suit requiring
payment of damages by BD relative to such features in such country, an amount
shall be deducted by BD from future royalties sufficient to reimburse itself for
one-half its damages and legal expenses incurred and paid by BD in such suit,
but in no event shall BD's royalty payments to LICENSOR be reduced below a [**]
royalty payable on such PATENTED PRODUCT in any country.
3. While this Agreement is in effect, should BD find it necessary, or
an exercise of reasonable business prudence, to obtain a license under any
patent rights from a third party in a particular country in order to render
marketable the PATENTED PRODUCT, because the PATENTED PRODUCT contains a feature
or feature under the LICENSED PATENT RIGHTS that is also covered by the patent
rights of the third party, it shall notify LICENSOR of such decision. If such a
third party license is obtained by BD, or as a result of a settlement entered
into with respect to patent rights dominant to the rights herein granted, BD is
required to pay and does pay royalties to such third party in respect of BD's
sales of such PATENTED PRODUCT in the particular country, the applicable
royalties payable to LICENSOR under paragraph 2(A) of Article 3, with respect to
the particular country, pursuant to this AGREEMENT may be reduced by BD by such
payments, but in no event shall BD's royalty payments to LICENSOR be reduced
below a [**] royalty payable on such PATENTED PRODUCT in such country.
Page 19
** Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
ARTICLE X - SUBLICENSING
------------------------
1. Sublicensing under this Agreement shall be the responsibility of BD.
Sublicenses granted under LICENSED PATENT RIGHTS by BD shall be non-exclusive
licenses.
2. The granting by BD of sublicenses of any PRODUCTS as defined herein
shall be in the discretion of BD and BD shall have the sole and exclusive power
to determine whether or not to grant sublicenses, the identity of the
sublicenses, royalty rates and terms and conditions of sublicenses. With respect
to any sublicenses granted by BD, BD shall be responsible for collecting
royalties and BD shall pay to LICENSOR royalties based on paragraphs 2(A) and
2(B) of Article III on the NET SALES of PRODUCTS of the sublicensee or as
otherwise agreed by LICENSOR. BD shall account to LICENSOR for such payments by
statements and payments as provided in paragraphs 1 and 2 of Article VII. The
granting by BD of licenses for any UNPATENTED RETRACTING HYPODERMIC PRODUCTS, as
defined in this Agreement, shall entitle LICENSOR to payments pursuant to
paragraph 2(B) of Article III of this Agreement or as otherwise agreed by
LICENSOR.
ARTICLE XI - DURATION AND TERMINATION
-------------------------------------
1. Unless sooner terminated as provided herein, this Agreement shall
continue in effect until the expiration of the last to expire of the LICENSED
PATENT RIGHTS having a VALID CLAIM.
2. This Agreement may be sooner terminated as follows:
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
(A) By LICENSOR effective immediately on notice to BD if BD: (i)
files a petition under the Federal Bankruptcy Code, or (ii) makes an assignment
for the benefit of creditors or has a receiver appointed for it, or otherwise
takes advantage of laws designed for the relief of debtors, all to the extent
permitted by the Intellectual Property Bankruptcy Protection Act (1988).
(B) Should a party hereto fail to perform any material covenant of
this Agreement, the sale and exclusive remedy of the non-defaulting party shall
be the dispute resolution provisions of Article VIII.
3. If BD becomes a non-exclusive licensee hereunder or BD ceases paying
royalties under paragraph 2(B) of Article III hereof, then BD shall and hereby
does grant a non-exclusive, royalty-free license to LICENSOR under U.S. Patent
No. 4,900,307 for the life of the patent in the FIELD.
ARTICLE XII - MISCELLANEOUS
---------------------------
1. Any notice or other communication required or permitted by this
Agreement shall be deemed to have been validly delivered on the date mailed if
the same shall be mailed by registered or certified mail, postage prepaid,
return receipt requested, or faxed with confirmation, addressed as follows:
To LICENSOR: Med-Design Corporation
0000 Xxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: _______________
Tel No.: ________________
Fax No.:_________________
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
With copy to: Xxxxx X. Xxxxxxx, Esq.
Dann, Dorfman, Xxxxxxx and Xxxxxxxx
Suite 720
0000 Xxxxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000-0000
Tel. No.: (000) 000-0000
Fax No.: (000) 000-0000
To BD: Becton, Xxxxxxxxx and Company
Becton Xxxxxxxxx Medical Systems
0 Xxxxxx Xxxxx
Xxxxxxxx Xxxxx, XX 00000-0000
Attention: President
Tel. No.: (201) _______
Fax No.: (201) 847-
With copy to: Becton, Xxxxxxxxx and Company
0 Xxxxxx Xxxxx
Xxxxxxxx Xxxxx, XX 00000-0000
Attention: Chief Intellectual
Property Counsel
Tel. No.: (000) 000-0000
Fax No.: (000) 000-0000
2. This Agreement shall not be assigned or transferable by either party
without the prior written consent of the other party, which consent shall not be
unreasonably withheld.
3. This Agreement shall be binding upon and inure to the benefit of the
successor and assigns of BD to which this Agreement relates and shall be binding
upon and inure to the benefit of the successors and assigns of the LICENSOR to
which this Agreement relates.
4. Nothing herein contained shall be construed to place the parties in
the relationship of partners or joint venturers or principal and agent or create
any entity or association, and neither party shall have the power to obligate or
bind the other in any manner whatsoever.
5. LICENSOR shall not use the name of BD or any adaptation thereof in
any advertising, promotion, sales literature or packaging in a manner which
would constitute an expressed or implied endorsement for any commercial product
without the prior written consent of BD.
Page 22
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
6. Nothing herein contained shall be construed to grant to LICENSOR any
license or rights in any of BD's intellectual property including, but not
limited to, BD's know-how, trade secrets, and patents which are assigned and/or
licensed to BD except as provided in this Agreement with respect to U.S. Patent
No. 4,900,307.
7. The field of the license granted by BD to LICENSOR in Appendix H of
the License Agreement of December 11, 1998 shall not include the FIELD of this
Agreement, except if this Agreement is terminated or BD becomes a non-exclusive
licensee hereunder.
8. Neither BD nor LICENSOR shall be responsible for and the terms of
this Agreement shall be inapplicable to any default or delays which are due to
cause beyond BD's or LICENSOR's control, including but without limitation, acts
of God or of the public enemy, acts or any order of a government, fires, floods,
or other natural disasters, embargoes, accidents, explosions, strikes, or other
labor disturbances (regardless of the reasonableness of the demands of labor),
shortages of fuel, power or raw materials, inability to obtain or delays of
transportation facilities, incidents of war, or other events causing the
inability of BD or LICENSOR, acting in good faith with due diligence, to perform
its obligations under this Agreement.
9. BD makes no warranty and will accept no liability for any expenses
or damages of whatever kind or nature, including consequential damages, incurred
by LICENSOR as a result of this Agreement, except as otherwise provided herein.
10. This Agreement constitutes the entire Agreement between the parties
hereto with respect to its subject matter, and no modification of this AGREEMENT
shall be effective unless it is in writing and is signed by a duly authorized
representative of each party. There are no understandings, representations or
warranties, except as herein expressly set forth, provided however Paragraphs 8
and 11 of the Binding Term Letter of March 12, 2000 remain in effect.
Page 23
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
11. The failure or delay of a party hereto to enforce any of its rights
under this Agreement shall not be deemed to be a continuing waiver or a
modification by such party of any of its rights under this Agreement.
12. Neither BD nor LICENSOR shall disclose the terms of this Agreement
as it relates to specific royalty rates or make any public announcement relating
to this Agreement without the consent of the other, which shall not be
unreasonably withheld, unless required by law. However, BD will cooperate with
LICENSOR on request by providing information, including launch dates for all
PRODUCTS under this Agreement and the License Agreement dated December 11, 1998
on a quarterly basis, such that LICENSOR can project LICENSOR's future revenues
from PRODUCTS hereunder and report such projected revenues as LICENSOR
reasonably deems necessary.
13. Should any part or provision of this Agreement be held
unenforceable or in conflict with the law of any jurisdiction, the validity of
the remaining part or provisions shall not be affected by such holdings.
14. This Agreement shall be construed, interpreted and applied in
accordance with and governed by the laws of the State of New Jersey, United
States of America.
IN WITNESS WHEREOF, LICENSOR and BD have caused this Agreement to be
duly executed in duplicate originals as of the date first hereinabove written.
The Med-Design Corporation Becton, Xxxxxxxxx and Company
By: ______________________________________ By: _________________________
Xxxxx Xxxxxxx Xxxx X. Xxxxx
President President, BD Medical
Systems
Date: ____________________________________ Date: _______________________
ATTEST
By: ______________________________________
Xxxxxx X. Xxxxxxxxxxx, III
Date: ____________________________________
Page 24
** Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
APPENDIX A
----------
U.S. PENDING PATENT APPLICATIONS
--------------------------------
Serial No. Country Filing Date
---------- ------- -----------
08/692,895 US 06/20/96
08/761,088 US 12/05/96
08/847,544 US 04/23/97
08/922,905 US 09/03/97
09/070,839 US 04/30/98
09/139,540 US 08/26/98
60/065,347 US 11/12/97
60/065,348 US 11/12/97
60/064,243 US 11/04/97
60/073,749 US 02/05/98
06/078,233 US 03/17/98
60/081,135 US 04/09/98
60/084,814 US 05/08/98
60/094,801 US 07/31/98
60/098,280 US 08/28/98
Page 25
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
APPENDIX A - continued
----------------------
U.S. ISSUED PATENTS
-------------------
Patent No.
----------
4,838,869
4,927,414
4,994,034
5,188,599
5,407,431
5,685,863
5,788,677
5,800,395
Page 26
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
APPENDIX A - continued
----------------------
PENDING PCT APPLICATIONS
------------------------
Application No. Filing Date
--------------- -----------
PCT/US97/15457 09/03/97
PCT/US97/22156 12/05/97
PCT/US97/22376 12/05/97
(not yet assigned) 08/27/98
Page 27
** Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
APPENDIX A - continued
----------------------
FOREIGN PATENTS AND APPLICATIONS BASED ON PCT APPLICATION
---------------------------------------------------------
Based on PCT Application No. PCT/US90/06462
Issued Patents:
Australia Patent No. 000000
Xxxxxxxx Patent No. 61026
European Patent No. 568,525
Designating: Austria, Belgium, Switzerland, Germany, Denmark,
Spain, France, United Kingdom, Greece, Italy,
Netherlands, Sweden
Hungary Patent No. 213,600
Japan Patent No. 0000000
Romania Patent No. 109160
Pending Patent Applications:
Brazil Patent Application No. 9008048
Canada Patent Application No. 2,096,026
European Patent Application No. 96114810.3 (Divisional)
Designating: Austria, Belgium, Switzerland, Germany, Denmark,
Spain, France, United Kingdom, Greece, Italy,
Netherlands, Sweden
Federation of Russia Patent Application No. 93043609
Finland Patent Application No. 932069
Norway Patent Application No. P931662
Ukraine Patent Application No. 93004375
Page 28
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
APPENDIX A - CONTINUED
----------------------
FOREIGN PATENTS AND APPLICATIONS BASED ON PCT APPLICATION
---------------------------------------------------------
Based on PCT Application No. PCT/US95/04501
Pending Applications:
Canada Patent Application No. 2,216,448
China Patent Application No. 95197813.6
European Patent Application No. 95916338.7
Designating: Austria, Belgium, Switzerland, Germany, Denmark,
Spain, France, United Kingdom, Greece, Ireland,
Italy, Luxembourg, Monaco, Netherlands, Portugal,
Sweden
Japan Patent Application No. 8-531673
Mexico Patent Application No. 97-8000
Singapore Patent Application No. 9705696-4
Based on PCT Application No. PCT/US96/13649
Pending Applications:
Canada Application No. 2,229,940
China Application No. 96197518.0
European Application No. 9692025.3
Designating: Austria, Belgium, Switzerland, Germany, Denmark,
Spain, France, United Kingdom, Greece, Italy,
Netherlands, Sweden
Japan Patent Application No. 9-510463
Mexico Application No. 000000
Xxxxxxxxx Application No. 9802000-1
Page 29
** Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
APPENDIX A - CONTINUED
----------------------
FOREIGN PATENTS AND APPLICATIONS
Non-PCT Foreign Issued Patents
------------------------------
Taiwan Patent No. NI-080032
Xxxxxx Xxxxxx Xx. XX-000000
Xxxxxx Patent No. NI-092939
Non-PCT Foreign Patent Applications
-----------------------------------
Indonesia Patent Application No. P-962739 filed 9/27/96
Page 30