EXHIBIT 10.8
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH
THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
AGREEMENT
THIS AGREEMENT, effective as of the 1st day of May, 1987, is by and between
the WISCONSIN ALUMNI RESEARCH FOUNDATION (hereinafter called WARF), a
corporation not for private profit, organized and existing under the laws of the
State of Wisconsin, and having its office at Madison, Wisconsin, and BONE CARE
INTERNATIONAL (hereinafter called Licensee or Bone Care), having its principal
place of business at 000 Xxxx Xxxxxxxx Xxxxxxx, Xxxxxxx, Xxxxxxxxx 00000. This
Agreement replaces and supersedes an Agreement between WARF and Lunar Radiation
Corporation ("Lunar") dated as of May 1, 1987 and assigned to Licensee, on
January 25, 1989, as amended.
W I T N E S S E T H
WHEREAS, XXXX is the owner by assignment of certain Letters Patent in the
United States relating to the compound 1 alpha-hydroxyergocalciferol (1 alpha-
HEC) which exhibits antirachitic and other properties and to methods for
preparing such compound; and
WHEREAS, it appears that substantial effort will have to be expended to
determine the efficacy, safety, and acceptability of such compound prior to
marketing for therapeutic purposes or for other purposes; and
WHEREAS, any part or all of such effort will require the expenditure of
substantial sums of money and time; and
WHEREAS, Licensee is willing to commit funds and effort to attempt to bring
the inventions of one or more of the aforesaid
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THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
patents and patent applications into use for the benefit of the public and to
that end desires to have a license under "Licensed Patents" as hereafter
defined;
NOW, THEREFORE, in consideration of the premises and the mutual promises
and obligations hereinafter set forth the parties hereto agree as follows:
1. DEFINITION
-------------
For purposes of this Agreement the following terms shall have the indicated
definitions:
(a) "Licensed Patents" shall refer to and mean U.S. Letters Patent No.
3,907,843 issued September 23, 1975, and patents in foreign countries which
correspond to said patent being those listed in Appendix B of this
Agreement, and reissues or extensions of such patents.
(b) "Ancillary Patents" shall refer to and mean those patents listed in
Appendix A and reissues or extensions thereof.
(c) "Products" shall refer to and mean the compound 1 alpha-
hydroxyergocalciferol (1 alpha-HEC) and combinations thereof with other
materials in a dosage form suitable for sale to the retail trade.
(d) "Processes" shall mean the processes described and claimed in Ancillary
Patents.
(e) "Compound" shall mean 1 alpha-hydroxyergocalciferol (1 alpha-HEC).
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH
THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
(f) "Ancillary Compounds" shall mean those compounds described and claimed in
Ancillary Patents which are intermediate in Processes.
(g) "Subsidiary" shall mean any corporation or organization
(1) at least fifty percent (50%) of whose stock entitled to vote upon
election of directors is owned or directly or indirectly controlled by
Licensee; or
(2) as much of whose stock entitled to vote upon election of directors is
owned or controlled by Licensee as permitted by law.
(h) "Net Selling Price" shall mean the invoice price of Products on an F.O.B.
factory basis after deduction of trade and quantity discounts, credits or
allowances because of the return of defective Products, and taxes or other
governmental charges on the sale, transportation or delivery of Products
absorbed by the Licensee.
In the case of sales of Products in combination with one or several
other therapeutic ingredients, the Net Selling Price shall be determined by
multiplying the invoice price of such combination, after the above-
mentioned deductions, by a fraction, the numerator of which shall be the
current wholesale selling price of the Product and the denominator of which
shall be the total of the current wholesale selling prices of all active
therapeutic ingredients in such combination including Product.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
(i) "Licensed Field" shall mean ethical or proprietary pharmaceutical Products
for consumption by or administration to humans.
(j) "Competing Use" shall mean any use of the Compound for the treatment of an
osteoporotic condition.
(k) "Development Protocol" shall mean the Appendix C summary overview attached
hereto and provided by Licensee detailing the activities believed necessary
to bring Products to the marketplace worldwide.
2. GRANT
--------
(a) (i) Subject to the terms and provisions set forth in this Agreement, all of
which are conditions of this grant, XXXX hereby grants and Licensee accepts
a worldwide license under Licensed Patents to make, have made for its
account, use and/or sell Products in Licensed Field, and under Ancillary
Patents to use Processes and Ancillary Compounds to make, or have made for
its account Products for use and sale in Licensed Field.
(ii) The license granted herein shall be exclusive to Licensee under
all Licensed Patents and the foreign patents listed in Appendix B attached
to this Agreement, except for a license to the Government of the United
States.
(iii) XXXX agrees that it will not license a third party to practice
Processes for the manufacture of Compound and Products for use or sale in
Licensed Field anywhere in
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THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
the world as long as this Agreement is in effect and if sale of Product is
being made in the United States, Bone Care is paying the Annual License Fee
described in section 3(d)(ii). Bone Care may credit the Annual License Fee
against royalties due and owing XXXX under Sections 3(c)(i) and 3(c)(ii) of
this Agreement for sales of Compound or Products in the United States.
XXXX agrees that it will add to Ancillary Patents (Appendix A) such
patents as it obtains which are directed to processes for making 1 alpha-
HEC for the purpose of making 1 alpha-HEC while this Agreement is in effect
and Licensee is fulfilling all of its obligations under its terms and
provisions.
(b) Licensee may, at its option, and without a formal sublicense, permit third
parties to practice Processes, to make Compound and Products and to make
and use Ancillary Compound but only on its behalf or for its account.
Licensee shall have the same responsibility for said activities of such
third party under any such arrangement as if the activities were those of
Licensee, whether or not said third party is also a licensee of XXXX under
Licensed Patents.
(c) This license is not to be construed as a warranty, either express or
implied, that Compound, Products, Processes, Ancillary Compounds, or
Method, or the practice of any of them, are free from third party patent
infringement
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
considerations. However, in the event Licensee pays royalties to any third
party for any additional patent license which is unavoidably and legally
necessary to practice the license granted by this Agreement, Licensee shall
be entitled to deduct fifty percent (50%) of the royalties paid to any such
third party under such additional patent license from the royalties due
XXXX under this Agreement, provided, however, that such deduction shall not
reduce the royalty payment to XXXX to less than one-half the amount
otherwise payable under this Agreement.
(d) Licensee accepts this license subject to a royalty-free irrevocable license
under any United States Letters Patents and the inventions thereof and any
additional inventions, and patent applications and patents pertaining
thereto, which may come within the scope of Licensed Patents and which have
been conceived and/or reduced to practice with funds obtained from the
Government of the United States, to the Government of the United States for
governmental purposes, and subject to the additional limitations which may
be imposed under PL 96-517 and PL 98-620 and OMB circular A-124 or other
regulations under those laws, or by any other entity which may fund
research leading to patent applications and patents which may come within
the scope of this Agreement.
XXXX warrants and represents that, as the designee of the University
of Wisconsin under the Institutional Patent
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
Agreement between the University and the then Department of Health,
Education and Welfare dated December 1, 1968, it has, to the best of its
knowledge and belief, been in compliance with the terms and provisions of
that agreement with regard to Licensed Patents and such Ancillary Patents
as come within the purview of that agreement.
(e) Where Licensee accepts the responsibility for payment and for as long as it
pays the royalty specified in Section 3 on the sale of Products it shall
have the right to extend to purchasers, mediate and immediate, of Products
sold by Licensee immunity from suit for infringement of Licensed Patents
arising out of such purchaser's resale and/or use of Products.
(f) Inasmuch as XXXX and the inventors named in Licensed Patents and Ancillary
Patents will not, under the provisions of this Agreement, or otherwise,
have control over the manner in which Licensee or its agents or those
operating for its account under Section 2(b), or third parties who purchase
Product from Licensee practice the inventions of Licensed Patents and
Ancillary Patents, Licensee shall hold XXXX and said inventors harmless as
against any judgments, fees, expenses, or other costs arising from or
incidental to any product liability lawsuit brought as a consequence of
Licensee's practice of said inventions. Practice of the inventions of
Licensed Patents or Ancillary Patents by a third party on behalf of or for
the account of Licensee or
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
by a third party who purchases Product from Licensee, shall be considered
Licensee's practice of said inventions for purposes of this Section 2(f).
(g) Licensee warrants that it now maintains and will continue to maintain
liability insurance coverage appropriate to the risk involved in marketing
Products and will annually present evidence to XXXX that such coverage is
being maintained.
(h) Notwithstanding any other provision of this Agreement, XXXX hereby grants
to Bone Care the right to sublicense others to use Processes and Ancillary
Compounds to make Products for sale in Licensed Field. Such sublicense
shall continue only for as long as this Agreement is in effect which fact
Bone Care agrees to state prominently and unambiguously in any document
conveying any such sublicense. In addition, such sublicense shall include
at least such provisions as will be necessary to permit Bone Care to meet
its obligations under this Agreement including, but not limited to: (1) the
obligation to pay royalties to XXXX; and (2) to hold XXXX and its inventors
harmless in the event of a product liability suit arising from the
sublicensee's use of Processes and, Ancillary Compounds to make Products or
Compound or from the sublicensee's use or sale of Compound and Products.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
Bone Care shall have the same responsibility to XXXX for the
activities of the sublicensee as if those activities were the direct
activities of Bone Care.
(i) Licensee and XXXX may each at its own discretion seek an extension of any
one or more European Licensed Patents where the laws and regulations of a
particular European country or the European Community permit an extension
to be obtained. Each party agrees to cooperate fully with the other party
in seeking such extensions, which shall be at Licensee's expense, except
that if the effort to obtain any one or more extensions is successful,
Licensee may credit one-half of the out-of-pocket expenses incurred in
obtaining the extensions against the royalties due XXXX under the
particular Licensed Patent.
3. CONSIDERATION
----------------
In consideration of the license granted herein, Licensee agrees that:
(a) No later than thirty (30) days after the effective date of this Agreement,
it will pay XXXX *** and upon receipt of an IND from the FDA it will pay an
additional ***. (It is acknowledged that these payments have been made to
XXXX.)
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
In consideration for the extension of worldwide rights to Licensee
under Section 2(a), Licensee agrees to make the following payments to XXXX
as additional initial license fees upon execution of this Agreement:
(1) For extending the rights to Japan, Australia, Korea, and New Zealand:
***.
(2) For extending the rights to France, Germany, Great Britain, Belgium,
Ireland, Netherlands, Switzerland, Denmark, Israel, Italy, and Sweden:
***. The additional license fees specified above shall not be
refundable or offset against any royalties due and payable to XXXX on
the sale of Products or the use of royalties as are required to be
paid by Licensee under the terms and provisions of this Agreement or
any predecessor thereof, whether the named Licensee is Lunar or Bone
Care. (It is acknowledged that these payments have been made to XXXX.)
(b) Licensee agrees to initiate the Development Protocol on or before December
31, 1990 and acknowledges that such agreement represents a substantial
obligation under the License. Licensee will establish and actively pursue
the worldwide development program described in Appendix C to the end that
at least one Product will be made available to the public worldwide in the
shortest reasonable time. At the beginning of each six-month period
commencing November 1, 1990, Licensee will supply XXXX with a copy of the
protocol
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
of the development program for each geographical area where it intends to
pursue development during the following six months. At the end of each such
six-month period, Licensee will furnish XXXX with a report indicating its
progress on such programs. Such protocols and reports shall be similar in
scope and content to the U.S. development protocols and reports previously
provided to XXXX under the License. XXXX agrees that it will not
communicate to any third party information which it receives from Licensee
and which has been identified by Licensee as being proprietary to it
without Licensee's express permission or unless or until such information
becomes available from another source or is in the public domain.
(c) It will pay XXXX royalties on the Net Selling Price of Products accruing
from the time of first public sale of the Product whenever manufacture, use
or sale of such Products, absent this license, would amount to an
infringement of any claim of the indicated Licensed Patent or Ancillary
Patent which has not been abandoned or disclaimed by XXXX or held invalid,
unpatentable or enforceable by a final adjudication of a judicial tribunal
of competent jurisdiction as follows:
(i) Under Licensed Patents - *** until the last to expire Licensed
Patents.
(ii) Under Ancillary Patents if one or more of Processes or Ancillary
Compounds is utilized in making Products or Compound:
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FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN
ACCORDANCE WITH THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R.
230.406 AND 200.80 PROMULGATED THEREUNDER. OMITTED INFORMATION HAS
BEEN REPLACED WITH ASTERISKS.
(a) other than in the United States and Japan - ***;
(b) in the United States - ***;
(c) in Japan, the royalty shall be *** until May 1, 1995, and *** after
that date.
In a given country, if a second party, other than Bone Care or a party with
which Bone Care has an arrangement, obtains approval of a New Drug
Application (NDA), or the foreign equivalent of an NDA, for Compound or
Products for a Competing Use, the royalty shall be reduced to *** beginning
upon the date the first significant sale for commercial purposes of
Compound or Products in Competing Use is made.
The royalties designated shall be additive except that in no event
shall Licensee pay a royalty which is greater than *** on the Net Selling
Price of Products.
(d) (i) Beginning upon January 1, 1992 Licensee will pay XXXX an annual minimum
royalty of ***, in equal calendar quarterly installments until the
expiration of United States Letters Patent No. 3,907,843 or any extension
thereof and thereafter not less than *** annually while Licensee, or a
third party through or by virtue of an arrangement with Licensee, uses any
of Processes or Ancillary Compounds in the United States and this Agreement
is in effect. In the
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ACCORDANCE WITH THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R.
230.406 AND 200.80 PROMULGATED THEREUNDER. OMITTED INFORMATION HAS
BEEN REPLACED WITH ASTERISKS.
event this Agreement is terminated within any given calendar year, the
minimum annual payments specified in this Section 3(d)(i) shall be prorated
to the number of months in the year of termination that the Agreement was
in effect.
The royalties earned from the sale of Products by Licensee in the
United States in accordance with the provisions of Sections 3(c)(i) or
3(c)(ii) may be offset against the minimum royalty due and payable under
this Section 3(d)(i). Typically XXXX requires additional minimum royalties
in consideration for granting rights in new territories. However, XXXX
hereby waives such minimum royalty requirements in consideration of
Licensee's past and present efforts to develop a Product.
(ii) In addition to the minimum royalty provided for in Section
3(d)(i) and in consideration for the rights granted Bone Care in Section
2(a)(iii) of this Agreement, Bone Care agrees that beginning with the first
significant sale of Product by Bone Care, or by a party with which Bone
Care has an arrangement permitting that party to sell Product, in the
United States and for fifteen (15) years thereafter, it will pay XXXX an
annual license fee (Annual License Fee) calculated at *** of the Net
Selling Price of Product sold in the United States. If a party other than
Bone Care or other than a party with which Bone Care has an arrangement
enters the market in the United States and sells Product in Competing Use,
Bone Care's obligation to pay the
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THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
annual License Fee shall continue only if Bone Care, or a party with which
Bone Care has an arrangement, continues to practice Processes. In the event
this Agreement is terminated within any given calendar year, the Annual
License Fee specified in this Section 3(d)(ii) shall be prorated to the
number of months in the year of termination that the Agreement was in
effect.
(e) Licensee shall have the right to sell Products, without payment of royalty
to XXXX, to other licensees of XXXX under Licensed Patents.
(f) The royalty to be paid XXXX on the Sale of Compound as a chemical per se,
i.e., not formulated for sale as Products in Licensed Fields, shall be
negotiated, except that royalties from the sale of Compound in such form
shall be substantially equivalent to the royalties obtained if Compound was
retained by Licensee and, after conversion to a final dosage form, sold in
that form as Products.
(g) In the event that Licensee or any of its sublicensees sell or otherwise
transfers Products or Compound to any of its Subsidiaries, which Compound
is then converted to Products by or on behalf of such subsidiary, monies
payable by Licensee under this Agreement shall be computed upon the Net
Selling Price of such Products as sold by such Subsidiary in accordance
with the royalty schedule set forth in Subsection 3(c).
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH
THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
(h) All royalties due and payable to XXXX in any calender quarter by Licensee
including minimum royalties, will be paid to XXXX within sixty (60) days
after the close of each such calendar quarter. Each royalty payment will be
accompanied by a statement showing all details necessary for royalty
calculation where pertinent to royalties payable and shall specify what
taxes, if any, have been withheld as required by law. Also included in such
report will be a statement of Products or Compound sold to the Government
of the United States on a royalty-free basis.
(i) All royalties required to be paid under this Agreement shall be calculated
and payable in United States dollars.
4. RECORDS
----------
Licensee agrees that it will maintain true and accurate records of all
factors necessary to properly calculate royalties. For a period of at least
three (3) years after the royalty period such records will be available for
inspection and audit by a Certified Public Accountant acceptable to Licensee at
reasonable times during Licensee's regular office hours, but only for purposes
of verifying royalty payments.
XXXX shall have the right in any year to request Licensee to submit a
written statement from a Certified Public Accountant verifying the accuracy and
completeness of royalty payments and reports made in accordance with this
Agreement.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH
THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
5. PATENT MARKING
------------------
Licensee agrees that it will apply appropriate patent markings for Licensed
Patents and Ancillary Patents on Products or Compound sold by it or its
subsidiaries under this Agreement.
6. ADVERTISING CLAIMS
----------------------
Any advertising of Products sold by Licensee or any of its subsidiaries
under this Agreement shall be free from extravagant or unwarranted statements
and shall contain no reference to Licensed Patents, the patentees thereof, the
University of Wisconsin or WARF except as provided in Section 5 above or except
with the written approval of XXXX.
7. TERM AND TERMINATION
------------------------
(a) This Agreement shall remain in force and effect until the date of
expiration of the last to expire of Licensed Patents and Ancillary Patents,
unless terminated sooner by agreement of the parties or as hereinafter
provided.
(b) Licensee may terminate this Agreement at any time in its entirety upon
ninety (90) days' notice in writing to XXXX.
(c) XXXX shall have the right to terminate this Agreement in the event Licensee
shall breach or default in any of its substantial obligations hereunder,
including the payment of royalties and minimum royalties when due and
payable, which breach or default remains uncorrected for sixty (60) days
after receipt by Licensee of notice of such breach or
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
default. For purposes of this Subsection it is understood that Licensee's
requirement to file a report under the provisions of Subsection 3(b) above
shall be considered a substantial obligation and that this Agreement may be
terminated by XXXX for Licensee's failure to file a report or in the event
that such report or other evidence indicates that there has been an absence
of real development activity on the part of the Licensee for the period
being reported upon.
(d) Termination of this Agreement by either party under any of the provisions
of this Section 7 shall not terminate Licensee's obligation to remit all
royalties and other payments theretofore accrued hereunder.
(e) Waiver by either party of a single breach or default, or a succession of
breaches or defaults, shall not deprive such party of any right to
terminate this Agreement arising by reason of any subsequent breach or
default.
(f) XXXX may terminate this Agreement if Licensee commits any act of
bankruptcy, becomes insolvent, files a petition under any bankruptcy or
insolvency act or has any such petition filed against it, or offers any
general composition to its creditors, because of the happening of such act,
event, or offer.
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THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
8. SCOPE AND ASSIGNABILITY
---------------------------
This Agreement shall extend to all Subsidiaries of Licensee but is
unassignable by Licensee except with the prior written consent of XXXX and
except that it may be assigned without such consent to the corporate successor
of Licensee or to a person, firm or corporation acquiring all, or substantially
all, or majority interest in the business and assets of Licensee.
9. NOTICES
----------
Any notice hereunder shall be deemed to be sufficiently given if sent by
registered letter, or by international cable or telex:
(a) in the case of WARF to:
Wisconsin Alumni Research Foundation
000 Xxxxxx Xxxxxx
Xxxxxxx, XX 00000
(b) in the case of Licensee to:
Bone Care International
000 Xxxx Xxxxxxxx Xxxxxxx
Xxxxxxx, XX 00000
10. MISCELLANEOUS
-----------------
(a) All matters affecting the interpretation, validity and performance of this
Agreement shall be governed by the laws of the State of Wisconsin.
(b) When Licensee shall have supplied XXXX with written evidence demonstrating
prima facie infringement of a claim of Licensed Patents by a third party
selling products in competition with Licensee and such sales are to the
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THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
substantial financial detriment of Licensee, Licensee may, by written
notice, request XXXX to take steps to terminate such infringement and
unless XXXX shall within six (6) months of the receipt of such notice
either (i) cause such infringement to terminate or (ii) initiate legal
proceedings against the infringer, Licensee may, upon written notice to
XXXX, initiate legal proceedings against the infringer in XXXX'x name and
at Licensee's expense, and may place in escrow royalty payments due in
connection with Licensee's sale of Products covered by such infringed
patent during the pendency of such proceedings. It is understood, however,
that in no event shall XXXX be required to conduct more than one
infringement suit at a time and that while such suit is pending, Licensee
shall not have the right to institute a suit against another nor to escrow
royalties.
In the event one party shall initiate or carry on legal proceedings to
enforce any of Licensed Patents against an alleged infringer, the other
party shall fully cooperate with, and supply all assistance reasonably
requested by the party initiating or carrying on such proceedings.
(1) In the event Licensee institutes proceedings under the provisions of
this Section 10(b) and obtains a judgment in its favor it may deduct
from royalty payments accrued to XXXX but held in escrow the direct
expenses incurred in such proceedings and return any balance, after
such deduction, to XXXX.
-19-
CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH
THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
(2) If the cost of the proceeding to Licensee is greater than the amount
of royalty escrowed, Licensee may continue to deduct from royalties
payable to XXXX such greater expenses until it has recovered the full
direct costs of such proceedings.
(c) In the event Licensee contests the validity of any of Licensed Patents all
rights and privileges extended under the terms and provisions of this
Agreement as to any of such contested Licensed Patents shall forthwith
cease and determine; but Licensee shall not be relieved from the payment of
royalties required or accrued under the terms and provisions of this
Agreement prior to such contest.
(d) This Agreement constitutes the entire Agreement between the parties hereto
with respect to the within subject matter and supersedes all previous
Agreements, whether written or oral. It shall not be changed or modified
orally. In the event that an unexpected incident renders a performance of
this contract physically or legally impossible, both parties agree to
negotiate an appropriate amendment to the Agreement.
-20-
CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH
THE SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80
PROMULGATED THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH
ASTERISKS.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their officers thereunto duly authorized.
WISCONSIN ALUMNI RESEARCH FOUNDATION
(SEAL)
/s/ Xxxx X. Xxxx
By:_________________________________
/s/ Xxxxxx Xxxxxx
Attest:_________________________________
BONE CARE INTERNATIONAL
/s/ Xxxxxxx X. Xxxxxx
(SEAL) By:_________________________________
/s/ Xxxxxxx X. Xxxxxx
Attest:_________________________________
-21-
CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
AMENDED APPENDIX A
ANCILLARY PATENTS
-----------------
================================================================================
REFERENCE PATENT ISSUED SERIAL
NUMBER COUNTRY NUMBER DATE NUMBER
================================================================================
Process for Preparing 1 alpha-Hydroxylated Compounds-DSHP
----------------------------------------------------
P77028US U.S. 4,202,829 05/13/80
P77028CA Canada 1,137,944 12/21/82
Process for Preparing 1 alpha-Hydroxy-Vitamin D Compounds for 1 alpha-Hydroxy-
------------------------------------------------------------------------------
3,5-Cyclovitamin D Compounds-DSHP
----------------------------
P79018US U.S. 4,234,495 11/18/80
P79018GB GT. Brit. 2,058,075 07/27/83
P79018IL Israel 60904 01/01/84
P79018IE Ireland 50195 07/11/86
Process for Preparing 1 alpha-Hydroxylated Compounds-DSPH
----------------------------------------------------
P79022US U.S. 4,260,549 04/07/81
P79022FR France 7,916,805 04/16/84
P79022BE Belgium 877,356 07/13/79
P79022NL Netherlands 7905040
Method for Preparing 1 alpha-Hydroxyvitamin D Compounds-DSLP
-------------------------------------------------------
P84017US U.S. 4,555,364 11/26/85
P84017AU Australia 4,867,485
P84017CA Canada 1,233,187 02/23/88
P84017DK Denmark 153,943
P84017IL Israel 76754
P84017JP Japan 60504750
P84017KR Korea 70040086
P84017NZ New Zealand 213,844
P84017IE Ireland 270,685
P84017EP EPO (BE,CH,LI,DE,FR,GB,IT,NL,SE) 859053530
5
CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
AMENDED APPENDIX A (cont.)
ANCILLARY PATENTS
-----------------
================================================================================
REFERENCE PATENT ISSUED SERIAL
NUMBER COUNTRY NUMBER DATE NUMBER
================================================================================
Method for Preparing 1 alpha-Hydroxyvitamin D Compounds-DSLP
-------------------------------------------------------
P84018US U.S. 4,554,106 11/19/85
P84018AU Australia 5064785
P84018CA Canada 1,233,188 10/15/85
P84018DK Denmark 153,836
P84018JP Japan 60504803
P84018KR Korea 70040186
P84018NZ New Zealand 213845
P84018EP EPO 859054561
P84018IE Ireland 270585
P84018IL Israel 76753
Process for Preparing 1 alpha-Hydroxylated Compounds-DSHP
----------------------------------------------------
P77027US U.S. 4,195,027 03/25/80
P77027CA Canada 1,156,251 11/01/83
P77032CA Canada (Div) 425,450
P77027FR France 79.00990 02/13/84
P77036FR France (Div) 81.08368 02/13/84
P77035FR France (Div) 83.11299 03/24/86
P77027DE Germany P2933189.3
P77039DE Germany (Div) P2954557.1
P77027GB Gt. Brit. 2,013,686 04/15/82
P77027BE Belgium 873,512 02/15/79
P77027IE Ireland 48,547 06/12/85
P77027NL Netherlands 7,900,331
P77027CH Switzerland 653,321 12/31/85
P77049CH Switzerland (Div) 658,050 12/15/86
P77027DK Denmark 147,912 06/17/85
P77034DK Denmark (Div) 3740/83
P77033DK Denmark (Div) 4361/82
P77027SE Sweden 7907631-1 01/26/84
P77027AU Australia 525,781 09/22/83
P77027JP Japan 1,197,578 03/21/84
P77030JP Japan (Div) 1,268,975 06/10/85
P77031JP Japan (Div) 1,268,976 06/10/85
P77050JP Japan (Div) 1,268,977 06/10/85
P77027NZ New Zealand 189,388 02/07/81
6
CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE
SECURITIES ACT OF 1933, AS AMENDED, AND 17 C.F.R. 230.406 AND 200.80 PROMULGATED
THEREUNDER. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS.
APPENDIX B
----------
Foreign Filing corresponding to U.S. Patent No. 3,907,843 (for foreign filing
combined with inventions of U.S. Patent No. 3,880,894 - License extended in this
Agreement applies only to l-alpha-HEC).
Country Patent No. Issue Date
------- ---------- ----------
France 7,513,243 January 25, 0000
Xxxxxx (Div.) 7,704,958 Xxxxx 00, 0000
Xxxx Xxxxxxx 2,518,842 July 12, 1978
Great Britain 1,503,942 March 15, 1978
16
