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Exhibit 10.8
*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN REDACTED PROVISIONS OF
THIS AGREEMENT. THE REDACTED PORTIONS ARE IDENTIFIED BY AN ASTERISK WITHIN
BRACKETS. THE CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.
LICENSE AGREEMENT
-----------------
THIS AGREEMENT made and effective this 28th of April 1994, by and
between DENTAL IMAGING ASSOCIATES, INC., a California corporation with a
principal place of business at 0000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx,
Xxxxxxxxxx 00000, (LICENSOR) and STERI-OSS, a wholly owned subsidiary of Bausch
& Lomb Incorporated, and a California corporation having a principal place of
business at 00000 Xxxx Xxxx Xxxxx, Xxxxx Xxxxx, Xxxxxxxxxx 00000, (LICENSEE).
WITNESSETH
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WHEREAS, LICENSOR is the exclusive licensee for certain dental
restorative products currently sold as THE DIA ANATOMICAL ABUTMENT SYSTEM(TM),
United States and foreign patents and patent applications related to such
products, related regulatory approvals, and related manufacturing know-how
related to such products;
WHEREAS, LICENSEE has experience in manufacturing, marketing, selling
and distributing various dental implants and related products; and
WHEREAS, LICENSOR is desirous of providing LICENSEE with the exclusive
rights to manufacture, use and sell such products; and
WHEREAS, LICENSEE is desirous of obtaining such exclusive rights.
NOW, THEREFORE, in consideration of the premises and mutual covenants
contained herein, the parties hereto hereby agree as follows:
1. DEFINITIONS
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The following terms as used in this Agreement shall have the meanings
set forth below:
1.1 "AFFILIATE" shall mean any corporation or other entity which,
directly or indirectly, is controlled by or controls, or is under common control
with a party to this
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Agreement. "Control" shall mean ownership of at least thirty-five percent (35%)
of the voting shares of such corporation or other business entity.
1.2 "INFORMATION" shall mean all technology, know-how, trade secrets,
technical data, clinical data, regulatory information and premarket
notifications and approvals, specifications, manufacturing methods or processes,
customer lists, sales data, and related information or experience in the
possession or control of LICENSOR and which LICENSOR has rights to provide to
LICENSEE and useful in the manufacture, use, sale or distribution of PRODUCTS,
as defined below, and all improvements thereto.
1.3 "INITIAL TERM" shall mean the period beginning from the effective
date of this Agreement and ending on December 31, 1999.
1.4 "IMPROVEMENTS" shall mean all modifications, changes and
improvements to PRODUCTS, as defined below, which fall within the scope of one
or more claims of a PATENT.
1.5 "NET SALES" shall mean the sales price of PRODUCTS by LICENSEE and
its AFFILIATES during the applicable accounting period to unrelated third
parties, less the following deductions: [*]. NET SALES shall exclude
complimentary PRODUCTS distributed by LICENSEE as samples to promote the sale of
PRODUCTS and PRODUCTS provided pursuant to Section 4.2. The NET SALES amount for
PRODUCTS sold in combination with non-royalty bearing products at a single price
(such as in a kit) shall be construed as [*]. For example, if the combination
sale price for three products was [*] and the standard list price for each
product sold separately and subsequently combined was [*], then the NET SALES
price shall be [*] less than the standard list price for the royalty bearing
PRODUCT.
1.6 "PATENTS" shall mean each United States patent and patent
application listed on Exhibit A-1 attached hereto and incorporated herein by
reference, all foreign patents and patent applications listed on Exhibit A-1,
each patent issuing upon a patent application referred to above, and all other
patent applications and patents owned or licensed by LICENSOR which would be
infringed by the manufacture, sale or use of PRODUCT(s). All U.S. and foreign
patent applications directed to IMPROVEMENTS of PRODUCTS shall be included in
PATENTS in accordance with Article 10.
1.7 "PRODUCTS" shall mean all abutments, healing caps, impression
coping cylinders and screws, and laboratory analogs currently manufactured, sold
or distributed by or for LICENSOR as listed on Exhibit B, attached hereto and
incorporated herein by reference, which are within the scope of any valid claims
of PATENTS and all IMPROVEMENTS subsequently added to Exhibit B as provided for
in this Agreement or by the mutual consent of the parties.
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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1.8 "RENEWAL TERM" shall mean a period of five (5) years commencing
after the expiration of the INITIAL TERM.
1.9 "TRADEMARKS" shall mean the trademarks and trade names and related
applications and registrations thereof, all listed in Exhibit C, attached hereto
and incorporated herein by reference, and any other trademarks or trade names
included and acknowledged in writing by the mutual consent of the parties.
1.10 Singular, Plural or Possessive. Any of the above-defined words
shall mean singular, plural or possessive and shall be used in the appropriate
form.
2. LICENSE
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2.1 LICENSOR hereby grants to LICENSEE and its AFFILIATES subject to
Section 2.2, the exclusive, worldwide license and right, with the right to grant
sublicenses, under all INFORMATION and PATENTS to make, have made, use, sell and
distribute PRODUCTS. LICENSOR hereby further grants to LICENSEE and its
AFFILIATES subject to Section 2.2, an exclusive, worldwide right to use the
TRADEMARKS, with right to sublicense upon and in connection with the
manufacture, use, sale, distribution and promotion of PRODUCTS.
2.2 LICENSEE acknowledges that LICENSOR has granted certain rights
relative to the PRODUCTS to [*] as reflected by the correspondence between
LICENSOR and [*] set forth as Exhibit E and has had communications with [*] as
reflected by the correspondence between LICENSOR and [*] attached hereto as
Exhibit F. LICENSOR hereby transfers and assigns its rights under the previous
grants to LICENSEE. LICENSOR's grant under Section 2.1 shall not be construed as
any reservation of right to the exclusive rights granted to LICENSEE.
3. ROYALTIES
---------
3.1 Within five (5) business days from the execution of this Agreement,
LICENSEE shall pay LICENSOR a non-refundable license fee of (i) [*], and (ii)
[*] which shall be fully creditable against royalty payments provided in Section
3.2 at a rate of [*] beginning upon the first full fiscal quarter of 1996 from
the effective date of this Agreement. Notwithstanding the above, LICENSEE shall
be entitled to recover the above-paid license fee as part of otherwise proven
damages in the event that LICENSOR has breached any material obligation or
covenant of this Agreement and LICENSEE shall be entitled to be reimbursed for
the balance of the [*] not credited as provided in Section 3.1 if LICENSOR shall
terminate this Agreement.
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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3.2 In addition to the royalty fee described in Section 3.1, LICENSEE
shall pay LICENSOR, during the term of this Agreement, an earned royalty payment
on the NET SALES of PRODUCTS at a rate of [*] for the INITIAL TERM and the
RENEWAL TERM(s). As long as there is a United States patent covering the
PRODUCT, royalties will be earned on all sales of such PRODUCT in any country of
the world.
3.3 LICENSEE's earned royalty payments to LICENSOR shall total at least
the following amounts (annual minimum royalty requirements) for each twelve
(12)-month period described below:
12-Month Period Annual Minimum Royalty
--------------- ----------------------
Fiscal year ending December 31, 1994 [*]
Fiscal year ending December 31, 1995 [*]
Fiscal year ending December 31, 1996 [*]
Fiscal year ending December 31, 1997 [*]
Fiscal year ending December 31, 1998 [*]
Fiscal year ending December 31, 1999 [*]
3.4 In the event that the actual earned royalty payments on NET SALES
do not meet the annual minimum royalty requirements of Section 3.3, LICENSEE
shall have thirty (30) days from the end of its fourth fiscal quarter of years
1996, 1997, 1998 and 1999 to make an additional payment to LICENSOR to pay the
differential between the earned royalty payment actually paid and the annual
minimum royalty requirement in order to meet such minimum royalty requirement
and retain its exclusive rights as granted herein. If LICENSEE does not meet
such minimum royalty requirement, LICENSEE's exclusive license as provided for
in Section 2.1 shall terminate at the election of, and upon written notice by,
LICENSOR.
3.5 No royalty shall be due on the sale or transfer of PRODUCTS between
LICENSEE and AFFILIATES and no PRODUCT shall be the subject of more than one
royalty payment to LICENSOR.
4. INVENTORY AND SUPPLY
--------------------
4.1 LICENSOR agrees to use its best efforts to assist LICENSEE in
establishing a suitable supply source of PRODUCTS.
4.2 LICENSEE shall provide PRODUCTS to [*].
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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5. TECHNICAL ASSISTANCE
--------------------
5.1 Upon request, LICENSOR shall furnish to LICENSEE, without
additional cost to LICENSEE except as provided in Section 5.2 below, reasonable
assistance to allow LICENSEE, or its AFFILIATES or agents, to commercially
manufacture, sell and distribute PRODUCTS. Such technical assistance shall
include providing to LICENSEE all relevant INFORMATION in LICENSOR's possession
necessary for the manufacture of each PRODUCT licensed herein.
5.2 LICENSOR agrees to furnish to LICENSEE such technical personnel of
LICENSOR as LICENSEE may reasonably require for assistance or consultation in
connection with the manufacture of PRODUCTS in accordance with this Paragraph.
[*] shall consult with LICENSEE for [*], provided such consultation is at the
business location of LICENSEE in California which is at 00000 Xxxx Xxxx Xxxxx,
Xxxxx Xxxxx, Xxxxxxxxxx 00000. LICENSOR shall also use its best efforts to make
available to LICENSEE [*] to provide additional assistance, provided such time
commitment shall not unreasonably interfere with [*]. LICENSEE agrees to provide
reasonable notice to LICENSOR of when it will require his assistance and
LICENSEE also agrees to pay all reasonable out-of-pocket expenses for travel,
meals and lodging of [*] including reasonable and customary compensation to be
agreed upon for providing lectures and technical assistance.
5.3 LICENSEE shall pay [*]. LICENSEE's clinicians shall consist of the
group of the following four individuals: [*]. LICENSOR agrees to make available
to LICENSEE [*] which lectures shall be given either at the business location of
LICENSEE or at an outside location at the option of LICENSEE. LICENSEE shall
have the right to designate which of the group of four it prefers to give a
specific lecture and LICENSOR shall use its best efforts to see to it that such
individual is available. The specific individual providing the lecture shall
receive reimbursement of all reasonable and direct out-of-pocket costs for
travel and lodging by LICENSE (if the lecture is provided outside the greater
Los Angeles area) and [*].
6. REPORTS AND RECORDS
-------------------
6.1 LICENSEE shall maintain true and complete books of accounts
containing an accurate record of all data necessary for the proper computation
of the earned royalty payments required hereunder. LICENSOR shall have the
right, by a licensed certified public accountant appointed by it and acceptable
to LICENSEE (such acceptance shall not be unreasonably withheld), to examine
such books under terms of confidentiality with LICENSEE. All such books shall be
available for inspection at all reasonable times upon five (5) business days
prior written notice (but not more than once in each calendar year) for the sole
purpose of verifying the accuracy of the reports rendered by LICENSEE. Such
examination shall be made during normal business hours at LICENSEE's principal
place of business and such right shall be limited to books not previously
examined. The fees and expenses of the representatives
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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performing such examination shall be borne by LICENSOR, unless the royalties due
and owing hereunder to LICENSOR are discovered to have been understated by more
than three percent (3%) over the period since the last such inspection, in which
event the fees and expenses shall be borne by LICENSEE. LICENSEE shall be
promptly notified of any underpayment or overpayment of royalties. Any
underpayment or overpayment shall be paid to the appropriate party within thirty
(30) days from notice of such underpayment or overpayment. All such books and
records shall be preserved for at least three (3) years from the date of the
royalty payment to which they pertain.
6.2 LICENSEE will submit to LICENSOR written reports for each of
LICENSEE's fiscal quarters accurately identifying worldwide NET SALES in
sufficient form and detail as to enable LICENSOR to determine the royalties due.
Not later than thirty (30) days following each quarter, LICENSEE shall provide
LICENSOR such reports in writing and showing a reasonable summary of all NET
SALES during the preceding quarter. Such report shall include payment to
LICENSOR of the royalties due.
6.3 Royalty payments on NET SALES which occur outside of the United
States of America shall be calculated in the currency of the transaction
involved. All royalty payments shall be paid in United States of America dollars
converted from local currency at the exchange rate prevailing at Citibank in New
York City, U.S.A. on the last business day of the fiscal quarter to which such
royalty relates.
6.4 If LICENSEE should sublicense its rights to an AFFILIATE or assign
this Agreement to an AFFILIATE, LICENSOR shall have the same rights and the
AFFILIATE shall have the same obligations as provided for LICENSEE herein.
LICENSEE shall guarantee the royalty payments of such AFFILIATE.
7. PATENTS AND PATENT APPLICATIONS
-------------------------------
7.1 LICENSOR shall be responsible for filing, prosecuting and
maintaining PATENTS in the United States. LICENSOR shall be responsible for
filing and prosecuting the foreign patents in the EPO and Canada for PATENTS as
set forth in Items Number 3 and 4 in Exhibit A up to the time of grant. In the
event LICENSEE is desirous of having patents issued in the various European
countries, LICENSEE shall be responsible for paying the grant and translation
fees for issuance of each such foreign patent in each of the sixteen countries
of the EPO where LICENSEE deems it appropriate to have patents issued. LICENSOR
shall be responsible for paying and maintaining the issuance of the patent in
Canada. For any patents or patent application added to this Agreement pursuant
to Section 10.2, the parties shall mutually agree upon allocating the costs
associated for filing, prosecuting and maintaining such patents.
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8. COMPLIANCE WITH GOVERNMENTAL REGULATIONS
----------------------------------------
8.1 LICENSEE shall use reasonable efforts with the reasonable
assistance, cooperation and consultation of LICENSOR, to obtain and/or file, at
its own cost and in its own name, new or amended regulatory approvals and/or
premarket notifications in order to manufacture, sell, and/or distribute
PRODUCTS throughout the world. LICENSOR shall provide LICENSEE with all
INFORMATION related to regulatory issues in its possession which are applicable
to PRODUCTS.
8.2 LICENSOR shall be responsible, at its own cost, to correct any
defects relating to existing regulatory approvals or licenses, including but not
limited to all 510K premarket notifications, which related to PRODUCTS.
8.3 In the event that any governmental regulatory agency should require
any changes in existing regulatory approvals, including 510K approvals, due to
changes in United States laws or regulations, the parties hereto shall equally
share all costs and expenses associated with obtaining such changes, including
new 510K approvals, for existing PRODUCTS. All minimum royalty requirements
provided for in Section 3.3 shall be stayed for the same period in which at
least half of the total number of PRODUCTS are no longer being sold due to such
changes in any approvals or licenses.
8.4 LICENSOR agrees to provide LICENSEE with all PRODUCT complaints,
including injury or other medical reports, and copies of all regulatory
correspondence with all governmental agencies relating to PRODUCTS.
9. COVENANT NOT TO COMPETE
-----------------------
9.1 During the term hereof and provided that neither LICENSEE or its
AFFILIATE are in breach of the terms herein beyond the cure period for same,
LICENSOR shall not associate commercially with or aid and assist any person or
entity for the purpose of developing, manufacturing, selling or distributing
product(s) which directly compete with PRODUCTS, nor shall LICENSOR itself
develop, manufacture, sell or distribute a competitive product(s). The
provisions of this Section 9.1 shall not apply to any new product for which
LICENSEE does not enter into a license agreement with LICENSOR pursuant to the
provisions of Section 10.2 herein below.
10. IMPROVEMENTS
------------
10.1 All IMPROVEMENTS to PRODUCTS that are developed, owned, or
acquired (with the right to license) by LICENSOR shall be promptly identified to
LICENSEE. LICENSEE shall have the right, at its sole election, to include such
IMPROVEMENTS in PRODUCTS at the then current royalty rate. Upon request of
LICENSEE, LICENSOR shall
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promptly provide all relevant information relating to such IMPROVEMENTS to
LICENSEE including providing technical assistance and regulatory assistance to
LICENSEE as provided for in Article 5.
10.2 LICENSOR shall promptly notify LICENSEE in writing whenever
LICENSOR shall have developed new products, however, [*] shall have the right to
perform preliminary studies and file for a United States patent application on
the new product at his expense before LICENSOR is required to disclose the new
product to LICENSEE. LICENSEE shall have ninety (90) days from the date of such
notice to inform LICENSOR of its desire to license such product under reasonable
terms and conditions to be mutually agreed upon. If LICENSEE and LICENSOR are
unable to agree on suitable terms and conditions for such license within ninety
(90) days from the end of such first ninety-day period, LICENSOR shall be free
to negotiate with third parties. However, prior to executing a license with any
third party on terms more favorable than those last offered to LICENSEE for such
products, LICENSEE shall have the right to license such Products under the same
terms and conditions to the terms and conditions LICENSOR would have granted to
such third party. All disclosures of new information and products under this
Section 10.2 shall be under suitable terms of confidentiality and a separate
non-disclosure agreement shall be executed by the parties for each such new
product.
10.3 Exhibit A-2 is a list of pending patent applications on current
new products which LICENSOR is providing to LICENSEE for review. With respect to
the patent applications listed on Exhibit A-2 only, LICENSEE shall have the
earlier of ninety (90) days from the issuance of the United States patent or one
hundred fifty (150) days from the execution of this Agreement to inform LICENSOR
of its desire to include such patent applications or patents in the license
granted herein with running royalty payments as provided for in Section 3.2. [*]
Upon inclusion of the patent applications listed on Exhibit A-2, all products
sold by LICENSEE which are within the scope of the patent applications listed on
Exhibit A-2 shall be construed as PRODUCTS and such patent applications shall be
construed as PATENTS in accordance with the terms and conditions of this
Agreement.
11. TRADEMARKS
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11.1 LICENSOR shall, at its sole expense, register, maintain, and
protect the validity of the TRADEMARKS for PRODUCTS. LICENSEE, subject to being
reimbursed for its out-of-pocket expenses, agrees to cooperate fully in good
faith with LICENSOR for the purpose of securing, reserving, and protecting
LICENSOR's rights in the TRADEMARKS.
11.2 LICENSEE acknowledges that its use of the TRADEMARKS during the
term of this Agreement shall inure to the benefit of LICENSOR. LICENSOR
acknowledges that LICENSEE has the exclusive license to use the TRADEMARKS,
subject to the terms of this
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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Agreement, and LICENSOR shall not use any of the TRADEMARKS in connection with
or association with any products.
11.3 All artwork, designs (excluding PRODUCT designs), promotional
materials and the like or any reproduction thereof created by LICENSEE, for use
in conjunction with the PRODUCTS pursuant to this Agreement shall be and remain
the property of LICENSEE.
11.4 Nothing herein shall require LICENSEE to use the TRADEMARKS in
association with the PRODUCTS nor prevent LICENSEE from using other marks in
association with the PRODUCTS should LICENSEE, at its sole option, determine to
do so. In the event that LICENSEE should select marks other than the TRADEMARKS
to use in connection with the PRODUCTS, all right and title in said trademarks
shall inure to LICENSEE.
11.5 LICENSOR shall have the right to inspect manufacturing facilities
of LICENSEE once a year upon ten (10) business days notice to insure that
LICENSEE complies with reasonable quality control standards imposed by LICENSOR
upon products distributed bearing TRADEMARKS. If these quality control standards
are not complied with, LICENSOR has the right to terminate the license as
provided for in Section 15.3 below. Such quality standards shall be provided to
LICENSEE within ten (10) days of the execution of this Agreement.
12. WARRANTIES
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12.1 LICENSOR hereby represents and warrants to LICENSEE:
12.1.1 That it is the sole and exclusive licensee of all right,
title and interest in all INFORMATION, PATENTS, TRADEMARKS and regulatory
licenses, approvals and premarket notifications free and clear of any
encumbrances including any encumbrances or, to the best of its knowledge, any
claims by [*], or its AFFILIATE or successor [*], and that, to the best of its
knowledge and belief, such PATENTS and TRADEMARKS are valid and enforceable.
12.1.2 That Exhibits A-1 and C are a complete and accurate listing
of all PATENTS and TRADEMARKS owned or controlled by LICENSOR on the date hereof
related to PRODUCTS and that Exhibit D, attached hereto, is an accurate listing
of all current customers of PRODUCTS and the sale history of PRODUCTS.
12.1.3 That there are no proceedings pending or threatened which
challenge the validity, enforceability, registration or use of PATENTS,
TRADEMARKS or regulatory licenses, approvals and premarket notifications.
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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12.1.4 That, to the best of its knowledge and belief, the
manufacture, use or sale of PRODUCTS will not infringe any patent, trademark, or
other proprietary rights of any third party.
12.1.5 That LICENSOR currently has entered into no agreements,
transactions or arrangements, except with respect to Japan and Italy (which
relationships have been fully disclosed to LICENSEE by LICENSOR), which would
limit or impair the rights granted to or its obligations to LICENSEE herein.
12.1.6 That, to the best of LICENSOR's knowledge and belief, the
PRODUCTS are safe and effective when used as intended.
12.1.7 That LICENSOR has obtained all regulatory approvals,
licenses, and findings of substantial equivalence resulting from premarket
notifications, necessary to market, sell and distribute PRODUCTS.
12.2 With regard to the above representations and warranties, LICENSEE
acknowledges receipt of certain correspondence between LICENSOR and [*] and
between LICENSOR and [*], as attached hereto as Exhibit G.
12.3 LICENSEE hereby represents and warrants to LICENSOR:
12.3.1 That it has the full authority enter into this Agreement.
12.3.2 That it has entered into no agreements, transactions or
arrangements that will limit or impair its ability to comply with its
obligations to LICENSOR herein.
12.3.3 During the term hereof and any renewals, LICENSEE and its
AFFILIATES will actively promote, market, sell and distribute the PRODUCTS in
accordance with reasonable commercial efforts substantially equivalent to those
efforts LICENSEE and its AFFILIATES use for their comparable products.
13. INDEMNIFICATION
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13.1 Each party shall indemnify and hold the other party harmless from
and against any other loss, liability or expense, including reasonable
attorneys' fees, arising out of or resulting from any demand, suit or claim
based on a breach or alleged breach of any of the parties obligations under this
Agreement; provided, however, that no settlement by a party of any claim which
would give rise to liability on the part of the other party shall be made
without the prior written consent of the other party, which consent shall not be
unreasonably withheld.
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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The other party shall communicate its decision with respect to any proposed
settlement within fourteen (14) days of the date it receives the request for its
consent.
13.2 LICENSOR acknowledges that any past relationships with [*]
relating to PRODUCTS has been terminated, as set forth in Exhibit H and LICENSEE
has not in any way affected LICENSOR's relationship with [*]. LICENSOR shall
indemnify and hold harmless LICENSEE from any loss, liability or expense,
including reasonable attorney fees, arising out of a claim made by [*] against
LICENSEE relating to its previous relationship with LICENSOR regarding PRODUCTS.
14. INFRINGEMENT
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14.1 In the event that either party shall learn of an infringement of
any PATENT or TRADEMARK (including any act of unfair competition), that party
shall call the other party's attention thereto in writing and shall provide such
other party with reasonable evidence of such infringement. Both parties shall
use their best efforts in cooperation with each other to terminate such
infringement without litigation. If the efforts of the parties are not
successful in abating the infringement within sixty (60) days after the
infringer has been formally notified of the infringement, LICENSEE shall have
the right to:
14.1.1 Commence suit on LICENSEE's own account for infringement of
its exclusive rights, subject to LICENSOR's right to fully participate in such
suit, at its own cost, in order to protect its rights;
14.1.2 Join with LICENSOR in such suit if LICENSOR brings suit
pursuant to Section 14.2 below or;
14.1.3 Refuse to bring such suit; and LICENSEE shall give notice
in writing to LICENSOR within thirty (30) days after said sixty (60) day period
of Section 14.1.
14.2 LICENSOR may bring suit for PATENT or TRADEMARK infringement on
its own account, if LICENSEE elects not to commence or join in any suit.
14.3 Such legal action as is decided upon shall be at the expense of
the party bringing suit, and all recoveries recovered thereby shall belong to
such party, provided, however, that legal action brought jointly by LICENSOR and
LICENSEE and fully participated in by both shall be at the joint expense of the
parties, and all recoveries up to the amount of such expense, shall be shared
jointly by them in proportion to the share of expense paid by each party, and in
the event such recoveries include damages or royalties in excess of expenses,
the amount in excess of expenses shall be shared by the parties on a
proportional basis as to their actual losses (for LICENSEE, lost gross profit;
for LICENSOR, lost royalties).
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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14.4 Each party agrees to cooperate, in all reasonable respects as
requested by the other party in litigation proceedings instituted hereunder and,
upon request of the party bringing suit, the other party shall make available to
the party bringing suit all relevant records, papers, information, samples,
specimens, and the like which may be relevant and in its possession. The party
bringing suit and incurring the majority of the associated costs shall have the
right to control such litigation.
14.5 In the event the making, using or selling of PRODUCTS is
determined by a court of competent jurisdiction to infringe one or more claims
of a patent(s) owned by a third party, no royalty payments shall be due LICENSOR
from the date such lawsuit is filed with respect to NET SALES in the territory
where such third party's patent rights are applicable. All royalty payments
shall be placed in an interest-bearing escrow account from the date that the
lawsuit is filed and maintained therein until final judgment. Provided, however,
that if such infringement results in a license to LICENSEE which enables
LICENSEE to continue making, using, or selling such PRODUCT in such part of the
territory, then the royalty payments due to LICENSOR with respect to NET SALES
in such territory following the date such lawsuit is filed or such settlement is
reached shall be reduced by the damages and/or royalty payments paid or to be
paid to such third party and the royalty payments to LICENSOR shall commence
only after the full recovery by LICENSEE of its reasonable costs and expenses in
defending such suit. In no event shall LICENSOR's earned royalty be reduced to
less than [*] due to earned royalty payments made to third parties by LICENSEE.
Should LICENSEE, be required to make additional payments to a third
party under this Section 14.5, the minimum royalty requirements provided for in
section 3.3 shall not longer apply.
15. TERM AND TERMINATION
--------------------
15.1 This Agreement shall become effective as of the date first written
above, and shall continue until December 31, 1999, (INITIAL TERM), unless sooner
terminated as provided for under this Agreement. Thereafter, the term shall be
renewed for an additional five (5)-year term (RENEWAL TERM) provided that [*].
Upon expiration of the RENEWAL TERM, the term shall be renewed until the last to
expire United States PATENT (either the term of such patent has expired or the
relevant claims have been held invalid by a court of competent jurisdiction)
which has claims covering such PRODUCT provided that LICENSEE has made total
cumulative payments to LICENSOR of [*]. Upon expiration, LICENSEE's license
herein shall be fully paid and irrevocable, however, any unpaid but accrued
royalties shall still be due and payable to LICENSOR.
15.2 LICENSEE may terminate this Agreement by giving ninety (90) days
prior written notice to LICENSOR.
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
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15.3 Either party may terminate this Agreement by notice to the other
party in the event of a material breach by such other party of its obligations
hereunder, which breach such other party has failed to cure within thirty (30)
days, in the case of any breach in the payment of amounts required hereunder, or
sixty (60) days, in the case of any other breach, after notice thereof.
15.4 The following rights and obligations survive any termination of
this Agreement to the degree necessary to permit their complete fulfillment or
discharge:
15.4.1 LICENSOR's rights to receive or recover, and LICENSEE's
obligations to provide reports as specified in Article 5 hereof and to pay
royalties accrued or accruable for payment at the time of any termination.
15.4.2 LICENSEE's obligation to maintain records as provided in
Article 5 hereof and LICENSOR's right to conduct a final audit thereof.
15.4.3 LICENSEE's right to complete the sale or distribution of
all PRODUCTS in inventory or in the process of being manufactured including the
right to sell or distribute any components of PRODUCTS to minimize its losses,
subject to LICENSEE's payments of royalties to LICENSOR as provided for herein,
provided, however, LICENSOR shall have the right to purchase all of such
PRODUCTS and inventory or in the process of being manufactured (collectively,
the "Remaining Inventory") under terms consistent with those terms then provided
by LICENSEE to its sub-licensees or customers for similar products. Within
twenty (20) days of any such termination, LICENSEE shall advise LICENSOR of the
amount of such Remaining Inventory, as well as the terms of purchase of same,
and LICENSOR shall have ten (10) days to advise LICENSEE of its intentions with
regard to the purchase of such Remaining Inventory. To the extent LICENSOR
elects to purchase such Remaining Inventory by notice to LICENSEE within such
time period, LICENSEE shall not have the right to sell or distribute same but
shall sell such Remaining Inventory to LICENSOR (such sales shall be non-royalty
bearing); to the extent LICENSOR does not so elect to purchase such Remaining
Inventory, LICENSOR shall have the right to sell and/or distribute same.
15.4.4 Any cause of action or claim of either party accrued
because of any breach or default by the other party.
15.5 Upon termination of this Agreement, LICENSEE agrees to return to
LICENSOR all prototype specimens, slides, blueprints and other materials
provided by LICENSOR to LICENSEE. LICENSEE shall return such material to
LICENSOR no later than ninety (90) days after the termination of this Agreement.
15.6 Upon termination and except as expressly set forth in this Section
15.4, LICENSEE acknowledges that neither it nor any of its AFFILIATES shall have
any rights whatsoever with regard to the INFORMATION, PATENTS, and/or the
TRADEMARKS, or to
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
13
14
the right to manufacture, sell or distribute PRODUCTS, and that all such rights
shall automatically revert to and be the exclusive property of LICENSOR.
16. FORCE MAJEURE
-------------
16.1 No failure or omission by either party in the performance of any
obligation under this Agreement shall be deemed a breach of this Agreement or
create any liability if the same shall arise from any cause or causes beyond the
control of the party, including but not limited to the following: acts of God,
acts or omissions of any government or agency thereof, compliance with rules,
regulations or orders of any governmental authority, fire, storm, flood,
earthquake, accident, acts of the public enemy, war, rebellion, insurrection,
riot, sabotage, invasion, quarantine or failures or delays in transportation.
17. CONFIDENTIALITY
---------------
17.1 Each party agrees that during the term of this Agreement and for a
period of three (3) years from the termination date of this Agreement, that it
will not disclose, publish, utilize for any purpose outside of that contemplated
by this Agreement or otherwise make known to any third party, except to
consultants and third party vendors under similar terms and conditions to those
herein, any confidential information it learns about or from the other party
through its relationship hereunder and including all INFORMATION of LICENSOR;
provided, however, that neither party shall be obligated to maintain in
confidence or not use information which:
17.1.1 Is, or subsequently may become available to the public
through no fault of the receiving party;
17.1.2 The receiving party can show was previously known to it at
the time of receipt;
17.1.3 May subsequently be obtained lawfully from a third party
who has obtained the information through no fault of the receiving party;
17.1.4 Is independently developed;
17.1.5 Is disclosed to a third party without a corresponding
obligation of confidence; or
17.1.6 Is in the opinion of the receiving party's legal counsel
required to be disclosed to a government agency or by operation of law provided,
however, that the receiving party takes such action as is available to preserve
the confidentiality of such
14
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information and to protect the same from disclosure under the Freedom of
Information Act or similar federal, state, or local disclosure laws, rules, or
regulations.
17.2 Neither party shall disclose to the public or to a governmental
agency the terms of this Agreement without the prior written consent of the
other party which shall not be unreasonably withheld.
18. NOTICES
-------
18.1 All notices, approvals, requests, demand and the like which are
required or permitted to be given under the terms hereof must be in writing.
They shall be given by mailing the same, postage prepaid by certified or
registered mail.
18.1.1 Those to be sent to LICENSEE shall be addressed to:
President
STERI-OSS
00000 Xxxx Xxxx Xxxxx
Xxxxx Xxxxx, Xxxxxxxxxx 00000
With a copy to:
Vice President & General Counsel
BAUSCH & LOMB INCORPORATED
Xxx Xxxxx Xxxxxx
X.X. Xxx 00
Xxxxxxxxx, Xxx Xxxx 00000-0000
or such other address as LICENSEE shall designate from time to time.
18.1.2 Those to be sent to LICENSOR shall be addressed to:
President
DENTAL IMAGING ASSOCIATES, INC.
c/o
----------------------------
--------------------------------
Xxxxxxxx, Xxxxxxxxxx 00000
15
16
With a copy to:
Xxxxxxx Xxxxxxx, Esq.
Lewitt, Hackman, Hoefflin, Shapiro,
Xxxxxxxx, Xxxxxx & Xxxxxxx
106633 Xxxxxxx Xxxxxxxxx
Xxxxxx, Xxxxxxxxxx 00000-0000
or such other address as LICENSOR shall designate from time to time.
18.2 Each notice so mailed as herein above provided shall be deemed
to have been given on the date of actual receipt.
19. GENERAL
-------
19.1 This Agreement contains the entire and only agreement between the
parties and supersedes all preexisting agreements, obligations, or claims
between them or their predecessors in interest relating to the subject matter
contained herein. Any representation, promise, condition, or obligation in
connection with such subject matter which is not incorporated in this Agreement
shall not be binding upon either party. No modification of this Agreement shall
be binding on the parties unless made in writing and signed on behalf of a duly
authorized representative of each party hereto.
19.2 Nothing in this Agreement shall be construed so as to require the
commission of any act contrary to law, and wherever there is any conflict
between any provision of this Agreement and any statute, law, ordinance or
treaty concerning the legal rights of the parties to the contract, the latter
shall prevail, but in such event the affected provisions of this Agreement shall
be curtailed and limited only to the extent necessary to bring it within the
applicable legal requirements.
19.3 Nothing in this Agreement shall be construed to make either party
hereto the agent, representative or partner of or a joint venturer with the
other party and neither party shall so hold itself out, nor shall either party
be liable or bound by any act or omission of the other party except as may be
expressly stated herein.
19.4 Except as is expressly stated herein, neither party grants to the
other party any other right or license under any of its patents, trademarks,
copyrights or trade secrets.
19.5 The Article headings of this Agreement are strictly for the
convenience of the parties and shall not be used in any way to restrict the
meaning or interpretation of the substantive language of this Agreement.
16
17
19.6 This Agreement and its effect are subject to and shall be
construed and enforced in accordance with the laws of the State of California.
IN WITNESS WHEREOF, the parties have caused this Agreement to be signed
in duplicate originals by their duly authorized representatives.
DENTAL IMAGING ASSOCIATES, INC.
(LICENSOR)
By:
----------------------------------
Title:
----------------------------------
STERI-OSS
(LICENSEE)
By:
----------------------------------
Title:
----------------------------------
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
17
18
I, [*] as licensor of PATENTS to LICENSOR, agree to be personally bound
by the obligations of LICENSOR in Sections 5, 9, 10 and 17 of this Agreement and
to use my best efforts to place LICENSOR, as a shareholder therein, in a
position to meet its obligations to LICENSEE as provided for in this Agreement.
----------------------------------
[*]
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
18
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EXHIBIT A-1
-----------
PATENTS
[* LIST OF PATENTS AND PATENT APPLICATIONS OMITTED]
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
19
20
EXHIBIT A-2
-----------
NEW PRODUCTS
[* LIST OF NEW PRODUCTS AND RELATED PATENTS AND PATENT
APPLICATIONS OMITTED]
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
20
21
EXHIBIT B
---------
PRODUCTS
Healing Caps HC045
(6) HC046
HC047
HC145
HC146
HC147
Anabomic Abutment
(9) AA0A
AA0B
AA0C
AA5A
AA5B
XX0X
XX0X
AA1B
AA1C
to include fixation screw
Pre-Angled Abutment
PAA515A
PAA515B
PAA515C
PAA525A
PAA525B
PAA525C
to include fixation screw
Impression Coping and Screw
ICSS (short)
ICSS (long)
Implant Coping Friction Driver
DTIS
Implant Laboratory Analog
ILRT
See attached description
21
22
EXHIBIT B-1
-----------
[* LIST OF PATENTS AND PATENT APPLICATIONS OMITTED]
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
22
23
EXHIBIT C
---------
TRADEMARKS AND TRADE NAMES
DIA(TM)
The DIA ANATOMIC ABUTMENT SYSTEM(TM)
23
24
EXHIBIT D
---------
DIA CUSTOMER LIST
[*32 pages omitted]
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
24
25
ADDENDUM TO LICENSE AGREEMENT
-----------------------------
THIS AGREEMENT made and effective this 11th day of April, 1995, by and
between DENTAL IMAGING ASSOCIATES, INC., a California corporation with a
principal place of business at 0000 Xxxxxxxx Xxxxxxxxx, Xxxxx 000, Xxxxxxx
Xxxxx, Xxxxxxxxxx 00000 ("LICENSOR") and STERI-OSS INC., a wholly owned
subsidiary of Bausch & Lomb Incorporated, and a California corporation having a
principal place of business at 00000 Xxxx Xxxx Xxxxx, Xxxxx Xxxxx, Xxxxxxxxxx
00000 ("LICENSEE").
W I T N E S S E T H
-------------------
WHEREAS, LICENSOR and LICENSEE entered into a License Agreement
effective April 28, 1994 (the "1994 AGREEMENT") wherein LICENSOR granted
LICENSEE exclusive rights to manufacture, use, and sell certain dental
restorative products known as THE DIA ANATOMICAL ABUTMENT SYSTEM according to
the terms and conditions therein set forth;
WHEREAS, Section 10.3 of the 1994 AGREEMENT provided LICENSEE with
rights: (a) to include products which are within the scope of the patent
properties listed in Exhibit A-2 of the that AGREEMENT as "PRODUCTS" (those
products being known as "THE NEW PRODUCTS") and (b) to include the patent
properties specified in Exhibit A-2 of the 1994 AGREEMENT as "PATENTS"; and
WHEREAS, LICENSEE has notified LICENSOR of its desire to acquire the
rights described above and the parties have negotiated the consideration and the
terms related to LICENSEE's acquisition of such rights;
NOW, THEREFORE, in consideration of the premises and mutual covenants
contained herein, the parties hereto hereby agree as follows:
1. The term "PATENTS" as used in the 1994 AGREEMENT shall hereinafter
include each United States patent application listed on Exhibit A-2 of the 1994
AGREEMENT and each patent issuing upon such patent applications; each non-United
States patent and patent application corresponding to the foregoing; and each
divisional, reissue, continuation, renewal, and extension of the foregoing.
2. LICENSOR represents and warrants that Exhibit B-1 attached hereto is
a complete and accurate listing of all patent properties included within PATENTS
as of the effective date of this Addendum and that Exhibit B-2 is a complete and
accurate listing of all products to be added under this Addendum.
3. The term "PRODUCTS" as used in the 1994 AGREEMENT shall mean all
products within the scope of any valid claim of PATENTS.
1
26
4. As reimbursement for its development and patent costs, LICENSEE
shall pay LICENSOR the following: [*]. LICENSEE agrees to use reasonable, good
faith efforts to overcome any regulatory issues that may arise and to use
reasonable, good faith efforts to resolve any assertion that the making, using,
or selling of PRODUCTS infringe one or more claims of a patent owned by a third
party. LICENSOR agrees to provide LICENSEE with reasonable assistance,
cooperation and consultation in overcoming any regulatory issues that may arise
and in resolving any assertion that the making, using, or selling of PRODUCTS
infringe one or more claims of a patent owned by a third party. Nothing in this
Paragraph 4 shall limit in any way LICENSEE's rights under the 1994 AGREEMENT,
especially Section 14.5 of that AGREEMENT.
5. Commencing with the first sale of a NEW PRODUCT, the table set forth
in Section 3.3 of the 1994 AGREEMENT will be replaced with the following:
12-Month Period Annual Minimum Royalty
--------------- ----------------------
Fiscal Year ending Dec. 31, 1994 [*]
Fiscal Year ending Dec. 31, 1995 [*]
Fiscal Year ending Dec. 31, 1996 [*]
Fiscal Year ending Dec. 31, 1997 [*]
Fiscal Year ending Dec. 31, 1998 [*]
Fiscal Year ending Dec. 31, 1999 [*]
6. LICENSEE agrees to pay LICENSOR's clinicians, [*] provided under
Section 5.3 of the 1994 AGREEMENT during the 12-month period commencing with the
effective date of this Addendum. This will be renewable on an annual basis at
the sole discretion of the LICENSEE during the initial term of the 1994
AGREEMENT. [*].
7. The parties agree that new product ideas should be presented to
LICENSEE before LICENSOR or its clinicians incur significant product development
costs. Accordingly, Section 10.2 of the 1994 AGREEMENT is amended to read as
follows:
Whenever LICENSOR conceives a new product, LICENSOR shall notify
LICENSEE of same in writing; this notification shall follow LICENSOR
having filed a patent application covering such new product, [*].
LICENSEE shall have ninety (90) days from the date of such notice to
inform LICENSOR of its desire to license such product under reasonable
terms and conditions to be mutually agreed upon, such terms and
conditions to include, without limitation, reimbursement of said
development and patent costs and such other sums as the parties shall
negotiate. If LICENSEE and LICENSOR are unable to agree on suitable
terms and conditions for such license within ninety (90) days from the
end of such first ninety (90)-day period, LICENSOR shall be free to
negotiate with
*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR REDACTED PORTIONS
2
27
third parties. However, prior to executing a license with any third
party on terms more favorable than those last offered to LICENSEE for
such products, LICENSEE shall have the right to license such Products
under the same terms and conditions as the terms and conditions
LICENSOR would have granted to such third party. All disclosures of new
information and products under this Section 10.2 shall be under
suitable terms of confidentiality and a separate non-disclosure
agreement shall be executed by the parties for each such new product.
8. If LICENSEE grants a sublicense under Section 2.1 of the 1994
AGREEMENT to a third party (any party other than one of LICENSEE's AFFILIATES as
defined in Paragraph 1.1 of the 1994 AGREEMENT) (said party referred to herein
as a "Third PARTY"), [*] relative to the PRODUCTS shall be payable by LICENSEE
to LICENSOR. Such payments shall be made quarterly with an accounting
substantially equivalent to that provided to LICENSOR relative to LICENSEE's
direct sale of PRODUCTS. Royalties and proceeds shall include sums received by
LICENSEE from the Third Party, less LICENSEE's direct, out-of-pocket expenses
solely attributable to the Third Party sublicense or grant. It is understood
that sale of PRODUCTS shall not constitute a sublicense within the meaning of
this Paragraph 8.
9. The terms of the 1994 AGREEMENT shall continue in full force and
effect except as modified herein. If there is any inconsistency between the
terms of the 1994 AGREEMENT and the terms of this Addendum, the terms of this
Addendum shall control.
3
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IN WITNESS WHEREOF, the parties have caused this Addendum to be signed
in duplicate originals by their duly authorized representatives.
DENTAL IMAGING ASSOCIATES, INC. (LICENSOR)
By:
---------------------------------------
Title:
---------------------------------------
Date:
---------------------------------------
STERI-OSS INC.
(LICENSEE)
By:
---------------------------------------
Title:
---------------------------------------
Date:
---------------------------------------
4
