EXHIBIT 10.42
LICENSE AGREEMENT
This License Agreement (the "Agreement") is entered into and
made effective the 6th day of December, 1996, (the "Effective Date") between
UNIVERSITY OF MIAMI and its Department of Ophthalmology whose principal place of
business is at 0000 X.X. 00xx Xxxxxx, Xxxxx Xxxxxxx 00000 (hereinafter referred
to as "LICENSOR") and Orphan Medical, a Minnesota Corporation, whose principal
place of business is at 00000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxxxxxxx, Xxxxxxxxx
00000 (hereinafter referred to as "LICENSEE").
WITNESSETH
WHEREAS, LICENSOR is the sole owner of U.S. Patent No.
5,098,443, Japanese Patent Application Serial No. 330811/91 and Canadian Patent
Application No. 2,056,138 (the Japanese and Canadian patent applications
collectively referred to herein as the "Patent Applications"), as well as the
technology described therein and entitled Method of Implanting Intraocular and
Intraorbital Implantable Devices for the Controlled Release of Pharmacological
Agents; Parel/UM88--06; and
WHEREAS, LICENSOR wishes to maintain the United States Patent,
obtain and maintain patents from the Patent Applications, and commercially
market the Product; and
WHEREAS LICENSOR warrants that it possesses the right to
license the aforestated patent and Patent Applications and to license and market
the Product; and
WHEREAS, LICENSOR wishes the LICENSEE to maintain the subject
Patent in the United States, obtain and maintain Patents from the Patent
Applications in the respective Territories, and to market the Product and
Process included within the Patent Rights; and
WHEREAS, LICENSEE desires to acquire an exclusive license in
the Territory for the following use: Human and Animal Health, with the right to
sublicense, under the Patent Rights (as defined in Paragraph 1.3 below) for the
purposes of making, having made for its own use and sale, using and selling
products and practicing the invention disclosed and claimed in the Patent
Rights.
NOW THEREFORE, in consideration of the above premises and the
obligation and covenants set forth below, the parties agree as follows:
1. DEFINITIONS:
1.1 "Affiliate" shall mean any corporation or other business entity
controlled by, controlling or under common control with LICENSOR or LICENSEE.
For this purpose, "control" shall mean direct or indirect beneficial ownership
of at least a fifty percent (50%) of the voting stock of, or at least a fifty
percent (50%) interest in the income of such corporation or other business
entity, or such other relationship as in fact, constitutes actual control.
1.2 "Sublicensee" as used in this Agreement shall mean any third party
to whom LICENSEE has granted a license to make, have made, use and/or sell the
Product or Process under the Patent Rights, provided said third party has agreed
in writing with LICENSEE to accept the conditions and restrictions agreed to by
LICENSEE in this Agreement.
1.3 "Patent Rights" shall mean U.S. Patent No. 5,098,443, Japanese
Patent Application Serial No. 330811/91 and Canadian Patent Application No.
2,056,138, and any continuations, divisional re-examinations, reissues,
improvements or extensions thereof and any patents issuing therefrom.
1.4 "Product" shall mean any product or part thereof (a) that is
covered in whole or in part by an issued, unexpired claim or a pending claim
contained in the Patent Rights in the country in which any Licensed Product is
made, used or sold; (b) that is manufactured by using a process which is covered
in whole or in part by an issued, unexpired claim or a pending claim contained
in the Patent Rights in the country in which any Licensed Process is used or in
which such product or part thereof is made, used or sold.
1.5 "Process" shall mean any process which is covered in whole or in
part by an issued, unexpired claim or pending claim contained in the Patent
Rights.
1.6 "Net Sales" shall mean the sum of all amounts invoiced on account
of sale or use of Products by LICENSEE and its Affiliates and any Sublicensees
to non-affiliated third party purchasers or users of Products, less (if invoiced
separately) (a) cash discounts to purchasers allowed in amounts customary in the
trade, (b) amounts for transportation or shipping charges to purchasers, (c)
credits for returns, allowances or trades, and (d) taxes and duties levied on
the sale of Products, whether absorbed by Licensee or paid by the purchaser.
1.7 "Territory" shall mean United States, Canada, and Japan.
1.8 "Field of Use" shall mean Human and Animal Health.
2. GRANT:
2.1 In consideration for payment of royalties, LICENSOR hereby, grants
to LICENSEE an exclusive license in the Territory for the Field of Use, with the
right to sublicense, under the Patent Rights, to make, have made for its own use
and sale, use and sell the Product and to practice any Process claimed in the
Patent Rights.
2.2 LICENSOR grants to the LICENSEE the authority to make application
for Patents, in the name of the LICENSOR in the Territory; all expenses of
obtaining and maintaining said patents shall be paid by LICENSEE.
2.3 LICENSOR retains the right to practice such invention for its own
research and educational use, and will not intentionally use such invention for
a commercial purpose.
3. TERM:
The license granted by this Agreement shall be Exclusive in the
License Field of Use in each country in the Licensed Territory for a term
commencing as of the effective date of this Agreement and ending on the first to
occur of the following:
(a) Twenty (20) years from the effective date; or
(b) Seventeen (17) years from the date of first commercial sale of a
licensed Product(s) by LICENSEE in each country in the Licensed Territory
(LICENSEE agrees to promptly inform LICENSOR in writing of the date of first
commercial sale); or
(c) expiration of the last to expire Patent Right within the
respective country. Thereafter, said license shall be nonexclusive until
expiration of the last to expire of the Licensed Patent(s) in each country
within the Territory.
4. UNITED STATES LAWS:
It is understood that LICENSOR is subject to United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities (including the Arms Export Control
Act, as amended and the Export Administration Act of 1979), and that its
obligations hereunder are contingent on compliance with applicable United States
export laws and regulations. The transfer of certain technical data and
commodities may require a license from the cognizant agency of the United States
Government and/or written assurances by LICENSEE that LICENSEE shall not export
data or commodities to certain foreign countries without prior approval of such
agency. LICENSOR neither represents that a license shall not be required nor
that, if required, it shall be issued.
5. PATENT PROTECTION AND INFRINGEMENT:
5.1 LICENSEE, during the term of this Agreement, is responsible for the
maintenance of U.S. Patent No. 5,098,443 and for the prosecution of the Patent
Applications. LICENSEE shall be responsible for all costs associated with such
maintenance and prosecution and shall have the authority to change the attorneys
responsible for such maintenance and prosecution subject to the approval of the
LICENSOR. Such approval by LICENSOR shall not be unreasonably withheld. In the
event a patent or patent(s) issue from the foregoing patent applications,
Licensee shall be responsible for the maintenance of such patents and shall be
responsible for all costs associated with such maintenance. In the event
LICENSOR desires additional patent applications to be filed in the Territory on
the invention(s) disclosed in the Patent Applications, it shall inform LICENSEE
in writing. LICENSEE must promptly notify LICENSOR of its intention to not file
additional patent applications. In such event, LICENSOR shall have the
opportunity to file additional patent applications. Any such additional patent
applications filed by LICENSEE shall fall within the definition of "Patent
Rights". Any such additional patent applications filed by LICENSOR shall not
fall within the definition of "Patent Rights".
5.2 LICENSEE shall promptly notify LICENSOR in writing of any claim of
Patent Rights infringement that it becomes aware of and that is asserted against
LICENSEE or LICENSOR, its Affiliates or any sublicensees because of the
manufacture, use, promotion and sale of Products by LICENSEE, its Affiliates or
any sublicensees.
5.3 LICENSEE will defend, indemnify and hold harmless LICENSOR, its
Trustees, officers, directors, employees and its Affiliates against any and all
judgments and damages arising from any and all third party claims of Patent
Rights infringement which may be asserted against LICENSOR or ITS Affiliates
because of the manufacture, use, promotion and sale of Products or Processes by
LICENSEE or its Affiliates or sublicensees. LICENSEE will bear all costs and
expenses incurred in connection with the defense of any such claims or as a
result of any settlement made or judgment rendered on the basis of such claims.
LICENSOR will have the right, but not the obligation, to retain counsel at its
expense in connection with any such claim. LICENSOR at its option, shall have
the right within thirty (30) days after commencement of such action, to
intervene and participate in the defense of the action and shall be responsible
for its own costs incurred in connection therewith (including attorneys fees).
LICENSEE shall not be responsible for any judgments, damages or other costs
arising from any and all third party claims of Patent Rights infringement which
may be asserted against LICENSOR and its AFFILIATES because of the manufacture,
use, promotion, and sale of Products or Processes by LICENSOR, its Affiliates or
any parties not licensed by LICENSEE. Neither party shall have any liability to
the other for any loss or damages incurred as a result of the invalidity of
LICENSOR'S Patent Rights.
5.4 Upon learning of any infringement of Patent Rights by third parties
in any country, LICENSEE and LICENSOR will promptly inform each other, as the
case may be, in writing of that fact and will supply the other with any
available evidence pertaining to the infringement. LICENSEE at its own expense
shall have the option to take whatever steps are necessary to stop the
infringement and recover damages therefor, and will be entitled to retain all
damages so recovered. In the event LICENSEE declines to bring suit, it shall so
inform LICENSOR in writing. Thereafter, LICENSOR shall have the right to take
any steps necessary (including commencement of suit) to stop the infringement.
LICENSOR shall bear all costs associated therewith and shall have the right to
recover damages therefore, and will be entitled to retain all damages so
recovered. In the event that LICENSOR and LICENSEE mutually agree to bring suit,
costs and expenses shall be shared equally and any recovery in excess of
expenses shall be shared equally. In any event, no settlement, consent, judgment
or other voluntary final disposition of the suit may be entered into without the
consent of LICENSOR, which shall not be unreasonably withheld.
5.5 LICENSOR shall have no responsibility with respect to LICENSEE'S
own trademarks and trade name, and LICENSEE in respect to the use thereof will
defend indemnify and hold harmless LICENSOR against any and all third party
claims related to such trademarks and trade names.
5.6 LICENSOR shall provide all reasonable assistance necessary for
LICENSEE to prosecute and maintain the patent(s) and patent applications
licensed hereunder.
6. INDEMNIFICATION:
6.1 LICENSEE agrees to release, indemnify and hold harmless LICENSOR,
its Affiliates, Trustees, officers, faculty, employees and students against any
and all losses, expenses, claims, actions, lawsuits and judgments thereon
(including attorney's fees through the appellate levels) which may be brought
against LICENSOR, its trustees, officers, faculty, employees or students as a
result of or arising out of any negligent act or omission of LICENSEE, its
agents, or employees, or arising out of use, production, manufacture, sale,
lease or advertisement by LICENSEE or its Affiliates or sublicensees of any
licensed Patent Right, Product or Process licensed under this Agreement.
6.2 This Agreement to reimburse and indemnify under the circumstances
set forth in Section 6.1 shall continue after the termination of this Agreement.
7. WARRANTIES AND DISCLAIMER:
7.1 LICENSOR represents and warrants to LICENSEE that:
(a) it is the sole owner of the Patent Rights licensed hereunder;
(b) that it is unaware of any claim of third party ownership of the
Patent Rights;
(c) to the best of its knowledge, U.S. Patent No. 5,098,443 is
valid and enforceable;
(d) it is unaware of any claim, asserted or unasserted, that the
Product or Process infringe any third party intellectual property rights;
(e) neither the Japanese nor Canadian patent application licensed
hereunder have been abandoned and that each application is being diligently
prosecuted; and
(f) LICENSOR has the power and authority to grant the licenses and
rights set forth in Article 2.
Article 2.
7.2 SUBJECT TO SECTION 7.1, NEITHER PARTY MAKES ANY WARRANTIES, EXPRESS
OR IMPLIED, AND HEREBY DISCLAIMS ALL SUCH WARRANTIES, AS TO ANY MATTER
WHATSOEVER, INCLUDING, WITHOUT LIMITATION, THE CONDITION OF ANY INVENTION(S) OR
PRODUCT, WHETHER TANGIBLE OR INTANGIBLE, LICENSED UNDER THIS AGREEMENT; OR THE
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE INVENTION OR
PRODUCT; OR THAT THE USE OF THE LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT,
COPYRIGHTS, TRADEMARKS, OR OTHER RIGHTS. LICENSOR SHALL NOT BE LIABLE FOR ANY
DIRECT, CONSEQUENTIAL, OR OTHER DAMAGES SUFFERED BY ANY OTHER PARTY OR ANY THIRD
PARTIES RESULTING FROM THE USE, PRODUCTION, MANUFACTURE, SALE, LEASE,
CONSUMPTION, OR ADVERTISEMENT OF THE PRODUCT.
7.3 It is expressly acknowledged and understood by LICENSOR that
LICENSEE makes no warranty or representation that it is possible to obtain a
patent based on Japanese Patent Application Serial No. 330811/91 or Canadian
Patent Application Serial No. 2056138 or, assuming patents are to issue on such
applications, that the scope of claim coverage will be satisfactory to LICENSOR.
LICENSEE shall use commercially reasonable efforts to obtain a patent from each
of the foregoing applications, with a reasonable scope of claim coverage.
7.4 The provisions of this Article 7 shall continue beyond the
termination of this Agreement.
8. ROYALTIES:
8.1 In consideration of the license herein granted, LICENSEE shall pay
royalties to LICENSOR as follows:
(a) License Issue Fee of *** said License Issue Fee shall be
deemed earned and due within 15 days of the execution of this
Agreement.
(b) Running Royalty in an amount equal to *** of the Net Sales of
the Products or Processes used, leased or sold by LICENSEE;
provided, however, that such percent shall be decreased to ***
for Net Sales in the event a patent does not issue on the
licensed Japanese and/or Canadian applications within three
years of the Effective Date of this Agreement (despite
LICENSEE'S commercially reasonable efforts to obtain a
patent); provided, however, that such decrease shall only
apply to Net Sales in the country where the patent does not
issue. Royalties from any sublicensee that manufactures the
Product or purchases it from a third party will be divided
equally between the LICENSEE and LICENSOR, and will not in any
case be below *** for the LICENSOR.
(c) Minimum Royalty of *** per year, starting three years after
first commercial sale of a Product or Process in the
Territory; provided, however, that the Minimum Royalty for a
given year shall be creditable against any Running Royalties
subsequently due during said year under subparagraph 8.1 (b)
above.
*** DENOTES CONFIDENTIAL INFORMATION THAT HAS BEEN OMITTED FROM THE EXHIBIT
AND FILED SEPARATELY, ACCOMPANIED BY A CONFIDENTIAL TREATMENT REQUEST,
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF
THE SECURITIES EXCHANGE ACT OF 1934.
8.2 All payments shall be made hereunder in U.S. dollars; provided
however, that if the proceeds of the sales upon which such royalty payments are
based are received by the LICENSEE in a foreign currency or other form that is
not convertible or exportable in dollars, and the LICENSEE does not have
on-going business operations or bank accounts in the country in which the
currency is not convertible or exportable, the LICENSEE shall pay such royalties
in the currency of the country in which such sales were made by depositing such
royalties in LICENSOR'S name in a bank designated by LICENSOR in such country.
Royalties in dollars shall be computed by converting the royalty in the currency
of the country in which the sales were made at the exchange rate for dollars
prevailing at the close of the business day of the LICENSEE'S quarter for which
royalties are being calculated as published the following day in the Wall Street
Journal (or, if it ceases to be published, a comparable publication to be agreed
upon from time to time by the parties), and with respect to those countries for
which rates are not published in the Wall Street Journal, the exchange rate
fixed for such date by the appropriate United States governmental agency.
8.3 In the event the royalties set forth herein are higher than the
maximum royalties permitted by the law or regulations of a particular country,
the royalty payable for sales in such country shall be equal to the maximum
permitted royalty under such law or regulation.
8.4 In the event that any taxes, withholding or otherwise, are levied
by any taxing authority in connection with accrual or payment of any royalties
payable to LICENSOR under this Agreement, the LICENSEE shall have the right to
pay such taxes to the local tax authorities on behalf of LICENSOR and the
payment to LICENSOR of the net amount due after reduction by the amount of such
taxes, shall fully satisfy the LICENSEE'S royalty obligations under this
Agreement.
9. COMMERCIALLY REASONABLE EFFORTS:
9.1 LICENSEE shall use its commercially reasonable efforts to
manufacture, market and sell the Products in the Territory and will exert
commercially reasonable efforts to create a demand for the Products.
9.2 LICENSEE agrees to submit reports, upon LICENSOR's request, of its
efforts to develop markets for the Products. Such reports shall include
assurance by LICENSEE of its intent to actively develop commercial embodiments
of the inventions of Licensed Patents and a summary of its efforts to
commercialize the Product. Such reports may be requested by LICENSOR no more
than three (3) times per calendar year.
9.3 LICENSOR may terminate this Agreement in the event LICENSEE does
not have a Product available for commercial sale prior to***. In the event
LICENSEE discontinues sales for more than three (3) months, LICENSOR may
terminate this Agreement upon written notice.
10. REPORTS AND RECORDS:
10.1 Commencing one (1) year after the first commercial sale, the
LICENSEE shall furnish to LICENSOR a report in writing specifying during the
preceding calendar quarter (a) the number or amount of Products sold or
Processes used hereunder by LICENSEE, and/or its Affiliates or sublicensees, (b)
the total xxxxxxxx for all such Products and Processes, (c) deductions as
applicable in paragraph 1.6, (d) total royalties due, (e) names and addresses of
all sublicensees. Such reports shall be due within forty-five (45) days
following the last day of each calendar quarter in each year during the term of
this agreement. Each such report shall be accompanied by payment in full of the
amount due LICENSOR in United States dollars calculated in accordance with
Section 8.1 hereof.
10.2 For a period of three (3) years from the date of each report
pursuant to Paragraph 10.1, LICENSEE, shall keep records adequate to verify each
such report and accompanying payment made to LICENSOR under this Agreement, and
an independent Certified Public Accountant or Accounting Firm selected by
LICENSOR and acceptable to LICENSEE may have access, on reasonable notice during
regular business hours, not to exceed once per year, to such records to verify
such reports and payments. Such Accountant or Accounting Firm shall not disclose
to LICENSOR any information other than that information relating solely to the
accuracy of, or necessity for, the reports and payments made hereunder. The fees
and expense of the Certified Public Accountant or Accounting Firm performing
such verification shall be borne by LICENSOR unless in the event that the audit
reveals an underpayment of royalty by more than ten (10%) percent, the cost of
the audit shall be paid by LICENSEE.
--------------------
*** DENOTES CONFIDENTIAL INFORMATION THAT HAS BEEN OMITTED FROM THE EXHIBIT
AND FILED SEPARATELY, ACCOMPANIED BY A CONFIDENTIAL TREATMENT REQUEST,
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF
THE SECURITIES EXCHANGE ACT OF 1934.
11. MARKING AND STANDARDS:
11.1 Prior to the issuance of patents on the Invention(s), LICENSEE
agrees to xxxx and have sublicensees xxxx Products (or their containers or
labels) made, sold, or otherwise disposed of by it under the license granted in
this Agreement with a proper patent notice as specified under the patent laws of
the United States.
11.2 LICENSEE further agrees to maintain satisfactory standards in
respect to the nature of the Product manufactured and/or sold by LICENSEE.
LICENSEE, agrees that all Product manufactured and/or sold by it shall be of a
quality which is appropriate to products of the type here involved. LICENSEE
agrees that similar provisions shall be included by sublicenses of all tiers.
12. ASSIGNMENT:
12.1 This Agreement is not assignable by LICENSEE or by operation of
law without the prior written consent of LICENSOR. Such consent shall not be
unreasonably withheld. In the event that substantially all of the assets of the
LICENSEE are acquired by another company, LICENSEE may assign this Agreement
without the prior consent of LICENSOR if the acquiring company agrees in
writing, prior to acquisition, to uphold all terms and conditions of this
Agreement.
12.2 This Agreement shall extend to and be binding upon the successors
and legal representatives and permitted assigns of LICENSOR and LICENSEE.
13. NOTICE:
Any notice, payment, report or other correspondence (hereinafter
collectively referred to as "correspondences') required or permitted to be given
hereunder shall be mailed by certified mail or delivered by hand to the party to
whom such correspondence is required or permitted to be given hereunder. If
mailed, any such notice shall be deemed to have been given when mailed as
evidenced by the postmark at point of mailing. If delivered by hand, any such
correspondence shall be deemed to have been given when received by the party to
whom such correspondence is given, as evidenced by written and dated receipt of
the receiving party.
All correspondence to LICENSEE shall be addressed as follows:
FOR NOTICE:
President
Orphan Medical Inc.,
00000 Xxxxxxxxx Xxxxx - Xxxxx 000
Xxxxxxxxxx, XX 00000
All correspondence to LICENSOR shall be addressed, in duplicate, as follows:
FOR NOTICE:
University of Miami School of Medicine Research
and Graduate Studies
P.O. Box 016960
0000 X.X. 00xx Xxxxxx
Xxxxx, XX 00000
Attention: Vice Xxxxxxx for Research
Assistant Vice President
Business Affairs
327 Xxx Xxxxxxx Building
0000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxx, Xxxxxxx 00000- 1432
Attention: Xx. Xxxx X. Xxxx
FOR NOTICE AND PAYMENT:
Director Office of Technology Transfer
P.O. Box 016960(M811)
Xxxxx, XX 00000
Attention: Xxxx Xxxxxxxx, Sc.D.
Either party may change the address to which correspondence to it is to be
addressed by notification as provided herein.
14. TERMINATION
14.1 LICENSOR and LICENSEE shall have the right to terminate this
Agreement if the other party commits a material breach of an obligation under
this Agreement or provides a false report and continues in default for more than
sixty (60) days after receiving written notice of such default or false report.
Such termination shall be effective upon further written notice to the breaching
party after failure by the breaching party to cure such default. If LICENSOR
commits a material breach or defaults, then LICENSEE has no duty to continue the
payment of royalties as set forth in Section 8 of this Agreement.
14.2 LICENSOR may terminate this Agreement in accordance with Section
9.3 of this Agreement.
14.3 The license and rights granted in this Agreement have been granted
on the basis of the special capability of LICENSEE to perform research and
development work leading to the manufacture and marketing of the Products.
Accordingly, LICENSEE covenants and agrees that in the event any proceedings
under the Bankruptcy Act or any amendment thereto, be commenced by or against
LICENSEE, and, if against LICENSEE, said proceedings shall not be dismissed with
prejudice before either an adjudication in bankruptcy or the confirmation of a
composition, arrangement, or plan of reorganization, or in the event LICENSEE
shall be adjudged insolvent or make an assignment for the benefit of its
creditors, or if a writ of attachment or execution be levied upon the license
hereby created and not be released or satisfied within ten (10) days thereafter,
or if a receiver be appointed in any proceeding or action to which LICENSEE is a
party with authority to exercise any of the rights or privileges granted
hereunder and such receiver be so discharged within a period of forty-five (45)
days after his appointment, any such event shall be deemed to constitute a
breach of this Agreement by LICENSEE and, LICENSOR, at the election of LICENSOR,
but not otherwise, ipso facto, and without notice or other action by LICENSOR,
shall terminate this Agreement and all rights of LICENSEE hereunder and all
rights of any and all persons claiming under LICENSEE.
14.4 LICENSEE shall have the right to terminate this Agreement upon
ninety (90) days notice.
14.5 Any termination of this Agreement shall be without prejudice to
LICENSOR's right to recover all amounts accruing to LICENSOR prior to such
termination and cancellation. Except as otherwise provided, should this
Agreement be terminated for any reason, LICENSEE shall have no rights, express
or implied, under any patent property which is the subject matter of this
Agreement, nor have the right to recover any royalties paid LICENSOR hereunder.
Upon termination, LICENSEE shall have the right to dispose of Products then in
its possession and to complete existing contracts for such Products, so long as
contracts are completed within six (6) months from the date of termination,
subject to the payment of royalties to LICENSOR as provided in Section 7 hereof.
15. CERTIFICATE OF INSURANCE:
15.1 SUBJECT TO SECTION 15.3, LICENSEE shall maintain liability
insurance coverage for the Product in the amount of three million dollars
($3,000,000) and at no expense to LICENSOR, LICENSEE shall name LICENSOR as an
additional insured. Within 15 days of the execution of this Agreement, LICENSEE
shall provide a certificate of insurance to LICENSOR.
15.2 SUBJECT TO SECTION 15.3, LICENSEE agrees to carry and keep in
force, at its expense, general liability insurance with limits not less than
$1,000,000 per person and $1,000,000 aggregate to cover liability for damages on
account of bodily or personal injury or death to any person, or damage to
property of any person; such insurance shall not be canceled for any cause
without at least 30 days prior written notice to University of Miami. Such
insurance shall contain an endorsement naming the University as an additional
insured with respect to this Agreement. Insurance Certificates should be sent to
the University of Miami attention Xx. Xxxxxxx Xxxxxx, 333 Xxx Xxxxxxx Building,
0000 Xxxxxxx Xxxxxx, Xxxxx Xxxxxx, Xxxxxxx 00000-0000.
15.3 In the event that the technology covered by the PATENT RIGHTS as
further defined as the LICENSED PRODUCT and PROCESS, provisions 1.3, 1.4, and
1.5 respectively, is marketed in the Territory, LICENSEE shall, at its expense,
maintain liability insurance coverage for the Product in the amount of five
million dollars ($5,000,000) and general liability insurance with limits not
less than $1,000,000 per person and $3,000,000 aggregate to cover liability for
damages on account of bodily or personal injury or death to any person, or
damage to property of any person. Such insurance shall not be canceled for any
cause without at least 30 days prior written notice to University of Miami. Such
insurance shall also contain an endorsement naming the University (LICENSOR) as
an additional insured with respect to this Agreement.
16. USE OF NAME:
LICENSEE shall not use the name of the University of Miami or any
of its employees, or any adaptation thereof, in any publication, including
advertising, promotional or sales literature without the prior written consent
of Xx. Xxxx X. Xxxx, Assistant Vice President of Business Services (or any
successor of Mr. Fish), 327 Xxx Xxxxxxx Bldg., 0000 Xxxxxxx Xxxxxx, Xxxxx
Xxxxxx, XX 00000-0000.
17. GOVERNING LAW:
This Agreement shall be governed by and interpreted in accordance
with the laws of the State of Florida.
18. CAPTIONS:
The captions and paragraph heading of this Agreement are solely for
the convenience of reference and shall not affect its interpretation.
19. SEVERABILITY:
Should any part or provision of this Agreement be held
unenforceable or in conflict with the applicable laws or regulations of any
jurisdiction, the invalid or unenforceable part or provision shall be replaced
with a provision which accomplishes, to the extent possible, the original
business purpose of such part or provision in valid and enforceable manner, and
the remainder of the Agreement shall remain binding upon the parties hereto.
20. SURVIVAL:
20.1 The provisions of Articles 5, 6 and 7 shall survive the
termination or expiration of this Agreement and shall remain in full force and
effect.
20.2 The provisions of this Agreement which do not survive termination
or expiration hereof (as the case may be) shall, nonetheless, be controlling on,
and shall be used in construing and interpreting, the rights and obligations of
the parties hereto with regard to any dispute, controversy or claim which may
arise under, out of, in connection with, or relating to this Agreement.
21. AMENDMENT:
No amendment or modification of the terms of this Agreement shall
be binding on either party unless reduced to writing and signed by an authorized
officer of the party to be bound.
22. WAIVER:
No failure or delay on the part of a party in exercising any right
hereunder will operate as a waiver of, or impair, any such right. No single or
partial exercise of any such right will preclude any other or further exercise
thereof or the exercise of any other right. No waiver of any such right will be
deemed a waiver of any other right hereunder.
23. CONFIDENTIALITY:
The Confidentiality Agreement signed by the parties and executed on
August 14, 1995 is hereby incorporated by reference. A copy of the Agreement is
attached hereto as Exhibit A. The term of Confidentiality Agreement shall be
extended to be coextensive with the term of this Agreement.
24. ENTIRE AGREEMENT:
This Agreement, and the Confidentiality Agreement referenced in
Section 23, constitutes the entire agreement between the parties hereto
respecting the subject matter hereof, and supersedes and terminates all prior
agreements respecting the subject matter hereof, whether written or oral, and
may be amended only by an instrument in writing executed by both parties hereto.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their respective officers thereunto duly authorized to be effective
as of the Effective Date.
ORPHAN MEDICAL
By: /s/ Xxxx Xxxxxxx
---------------------------
Name: Xxxx Xxxxxxx
-------------------------
Title: President
------------------------
Date: 00-0-00
-------------------------
XXXXXXXXXX XX XXXXX
By: /s/ Xxxx X. Xxxx
---------------------------
Name: Xx. Xxxx X. Xxxx
-------------------------
Title: Assistant Vice President, Business Affairs
------------------------------------------
Date: 12-6-96
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EXHIBIT A - CONFIDENTIALITY AGREEMENT
CONFIDENTIAL DISCLOSURE AGREEMENT
FOR INFORMATION EXCHANGED BETWEEN ORPHAN MEDICAL INC.
AND AN EXTERNAL SOURCE
This Agreement is made and entered into this 14th day of August, 1995 by and
between ORPHAN MEDICAL INC. which is a Minnesota corporation, located at 00000
Xxxxxxxxx Xxxxx; Xxxxxxxxxx, XX 00000 ("ORPHAN MEDICAL") and Xxxxxx Xxxxxx Eye
Institute, a part of University of Miami (the "POTENTIAL-COLLABORATOR") located
in Miami, FL.
A. ORPHAN MEDICAL and the "POTENTIAL-COLLABORATOR" have entered into certain
discussions the purpose of which is to explore and consider the possibilities of
a business relationship between, or other transaction involving, ORPHAN MEDICAL
and the "POTENTIAL-COLLABORATOR".
B. In this connection with and in furtherance of this possible business
relationship, it is anticipated that both of the undersigned parties (i.e.
ORPHAN MEDICAL and the POTENTIAL-COLLABORATOR) at various times will disclose
(the "DISCLOSING PARTY") and receive (the "RECEIVING PARTY") certain information
with each other which the undersigned parties consider proprietary and
confidential.
The undersigned RECEIVING PARTY in consideration for the use of certain
information, knowledge, software, data and/or know-how (hereinafter called
"INFORMATION") related to drug delivery product for 5FU made available to it by
DISCLOSING PARTY hereby agrees as follows:
1. RECEIVING PARTY agrees to keep in confidence and not to use the
INFORMATION for its commercial benefit (except for technical and
economic evaluation) for a period of five (5) years from the date
hereof.
2. RECEIVING PARTY further agrees that it shall keep in confidence and
not disclose any part of INFORMATION to a third party for a period of
five (5) years from the date hereof.
3. Obligations of RECEIVING PARTY shall not apply to any information,
knowledge, software, data and/or know-how which:
(a) is or hereafter becomes a part of the public domain through no
fault of RECEIVING PARTY;
(b) RECEIVING PARTY can demonstrate was in its possession prior to
the time of disclosure by DISCLOSING PARTY or can demonstrate was
received by it from a third party who shall not have received
same from DISCLOSING PARTY
4. RECEIVING PARTY agrees to obligate its employees who shall have access
to any portion of INFORMATION to protect the confidential and
proprietary nature of INFORMATION.
5. This Agreement shall be governed by and interpreted in accordance with
the laws of the State of Minnesota.
ACCEPTED AND AGREED BY BOTH PARTIES
QUALIFIED OFFICER OF THE POTENTIAL ORPHAN MEDICAL QUALIFIED OFFICER
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COLLABORATOR'S ORGANIZATION
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Authorized Signature: /s/ Xxxxxxx X. XxXxxxx Authorized Signature: /s/ Xxxx Xxxxxxx
Name (Print): Xxxxxxx X. XxXxxxx Name (Print): Xxxx Xxxxxxx
Title: Director Technology Transfer Title: President
Date: 8/14/95 Date: 7-31-95
