EXHIBIT 10.246
AMENDED AND RESTATED
LICENSE AGREEMENT BETWEEN
THE SALK INSTITUTE FOR BIOLOGICAL STUDIES
AND LIGAND PHARMACEUTICALS INCORPORATED
ARTICLE 1 - DEFINITIONS......................................................2
ARTICLE 2 - LICENSE GRANT....................................................3
ARTICLE 3 - [INTENTIONALLY OMITTED]..........................................4
ARTICLE 4 - PAYMENTS TO SALK.................................................4
ARTICLE 5 - COMMERCIALIZATION................................................9
ARTICLE 6 - TRANSMISSION OF INFORMATION AND KNOW-HOW.........................10
ARTICLE 7 - CONSULTING.......................................................11
ARTICLE 8 - REPORTS AND RECORDS..............................................11
ARTICLE 9 - INFRINGEMENT OF PATENT RIGHTS....................................12
ARTICLE 10 - TERM 13
ARTICLE 11 - TERMINATION.....................................................13
ARTICLE 12 - SURVIVAL OF RIGHTS..............................................14
ARTICLE 13 - AGENCY..........................................................14
ARTICLE 14 - USE OF SALK'S NAME..............................................14
ARTICLE 15 - NONDISCLOSURE OF CONFIDENTIAL INFORMATION.......................14
ARTICLE 16 - WARRANTY........................................................14
ARTICLE 17 - DISCLAIMER OF LIABILITY AND INDEMNITY...........................15
ARTICLE 18 - INSURANCE.......................................................16
ARTICLE 19 - FORCE MAJEURE...................................................16
ARTICLE 20 - ASSIGNMENT......................................................16
ARTICLE 21 - APPLICABLE LAW AND ARBITRATION..................................17
ARTICLE 22 - NONWAIVER.......................................................17
ARTICLE 23 - SEVERABILITY....................................................17
ARTICLE 24 - OFFICIAL NOTICES................................................17
ARTICLE 25 - NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION
AND PATENT TERM RESTORATION ACT.................................18
ARTICLE 26 - ENTIRE AGREEMENT................................................19
AMENDED AND RESTATED
LICENSE AGREEMENT
This Amended and Restated License Agreement, effective as of the 12th day
of April 2002, by and between THE SALK INSTITUTE FOR BIOLOGICAL STUDIES, a
nonprofit corporation organized under the laws of the State of California,
having an address at 00000 Xxxxx Xxxxxx Xxxxx Xxxx, Xx Xxxxx, Xxxxxxxxxx 00000
(hereinafter referred to as "SALK") and LIGAND PHARMACEUTICALS INCORPORATED, a
corporation organized under the laws of the State of Delaware, having an address
at 00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000 (hereinafter referred
to as "LIGAND").
WHEREAS, SALK scientists in the Xxxxxx Xxxxxx Medical Institute
(hereinafter referred to as "HHMI") laboratory of Dr. Xxxxxx Xxxxx (hereinafter
referred to as "Xx. Xxxxx") have characterized and cloned various intracellular
steroid and steroid-like receptors that modulate gene expression, including the
glucocorticoid, aldosterone, thyroid hormone, and retinoic acid receptors;
WHEREAS, steroid and steroid-like hormones have a wide range of
physiological actions, some already being used in therapeutic applications, and
there is great pharmacologic potential for further agonists and antagonists of
these hormones;
WHEREAS, these scientists at SALK have also developed a new screening
system that promises to offer unusually effective screening for hormones and
analogs of hormones that bind to these receptors;
WHEREAS, SALK has filed various U.S. and foreign patent applications
covering said receptors as well as the screening system;
WHEREAS, certain technology developed at SALK and included in pending
patent applications, relating to intracellular steroid and steroid-like
receptors and methods to screen compounds using such receptors is of interest to
LIGAND; and
WHEREAS, the parties desire to amend and restate this Agreement to
consolidate all prior amendments (Amendment to License Agreement effective as of
the 15th day of September, 1989, Second Amendment to License Agreement effective
as of the first day of December 1989, and Third Amendment to License Agreement
effective as of the 20th day of October 1990) and to clarify and in certain
regards to further amend their mutual and respective obligations under the
Agreement.
NOW, THEREFORE, in consideration of the foregoing and of the mutual
covenants, promises and conditions hereinafter set forth, the parties agree as
follows:
ARTICLE 1 - DEFINITIONS
1.1 The term "Patent Rights" shall include (A) U.S. Patent Application
Serial No. 922,585, filed October 24, 1986; U.S. Patent Application Serial No.
108,471, filed October 20, 1987; and U.S. Patent Application Serial No. 128,331,
filed December 2, 1987 plus any continuations, continuations-in-part, divisions,
reissues and foreign counterparts thereof, and any subsequently filed
applications covering Improvements, and any patents issuing thereon; and (B)
U.S. Patent Application Serial No. 177,740, filed December 30, 1993; U.S. Patent
Application Serial No. 669,846, filed June 26, 1996; and U.S. Patent Application
Serial No. 669, 779, filed June 26, 1996 plus any continuations,
continuations-in-part, divisions, reissues and foreign counterparts thereof, and
any subsequently filed applications covering Improvements, and any patents
issuing thereon (the "GAL-4 Patent Family"); and to the extent not falling
within (A) or (B) above, (C) those U.S. and/or foreign patent applications and
patents owned or controlled by SALK, which relate to Receptors and to assays for
or using Receptors and any other such patent applications and patents which are
useful in the discovery and development of molecules that modulate the activity
of Receptors in humans, animals, insects, and plants for therapeutic or growth
regulatory applications, developed by Dr. Xxxxxx Xxxxx and other scientists in
the HHMI laboratory of Xx. Xxxxx at SALK up to October 20, 1993. A current
listing of such U.S. and foreign patents and patent applications is set forth in
the attached Schedule A to this Agreement.
1.2 The term "Know-How" shall mean any and all unpublished information,
data and specifications relating to the Receptors and to screening methods and
assays disclosed in the Patent Rights which is known to SALK and which SALK is
free to disseminate without accounting to others.
1.3 The term "Technology" shall mean information embodied in the patent
applications and patents comprising Patent Rights and in the Know-How and shall
include information in subsequently filed applications which cover Improvements.
1.4 The term "Improvements" shall mean inventions which are covered by, or
the use of which would be covered by, any of the claims of the U.S. Patent
Application Serial No. 922,585, filed October 24, 1986; U.S. Patent Application
Serial No. 108,471, filed October 20, 1987; and U.S. Patent Application Serial
No. 128,331, filed December 2, 1987, any subsequent continuations,
continuations-in-part, divisions, reissues and foreign counterparts thereof or
patents issuing thereupon.
1.5 The term "Licensed Product" shall mean each drug or other product which
is identified, confirmed, characterized, developed, validated or tested using
the Technology or which is within the scope of any claim in an issued patent or
pending application included in the Patent Rights; provided, however, with
respect to any Licensed Product which is a drug or other product that is already
a Licensed Product but for which a new NDA or SNDA for a new indication, use or
patient population is filed (the "Referenced Licensed Product") each shall be
considered a distinct and separate Licensed Product for purposes of this
Agreement, excluding new formulations or changes in dosage strengths of an
already approved Licensed Product, unless such new formulation or dosage
strength
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addresses the same indication or use among the same patient or user population
as the Referenced Licensed Product. For the avoidance of doubt, a new drug
combination that meets the foregoing definition shall be deemed a new Licensed
Product unless such new drug combination addresses the same indication or is
targeted for use among substantially the same patient or user population as the
Referenced Licensed Product.
1.6 The term "Licensed Service" shall mean the screening of compounds on
behalf of a third party using the Technology, or the performance on behalf of a
third party of a screening method within the scope of any claim of an issued
patent or pending application included in the Patent Rights.
1.7 The term "Net Sales" shall mean the gross proceeds resulting from sales
of Licensed Products by LIGAND less (i) forwarding expenses, postage and duties
actually paid or allowed and taxes imposed directly on a seller of products with
respect to the sale of products; (ii) any credit given for products returned or
recalled and for reductions in price; (iii) distributor discounts and (iv)
insurance expense.
1.8 The term "Fully Burdened Costs" shall mean direct costs of labor,
materials, and subcontract costs incurred, plus indirect costs such as those for
quality assurance and other production or related overhead costs incurred, plus
an apportioned pro rata share of general and administrative costs related to
said direct and indirect costs, each determined in accordance with generally
accepted accounting principles, as more particularly laid out in Schedule B.
Schedule B may be revised from time to time by agreement of the parties to more
accurately reflect the treatment of costs then in effect.
1.9 The term "Receptors" shall mean intracellular steroid receptors and
steroid receptor related proteins as defined in Exhibit A attached hereto.
1.10 The term "cis-trans Assay" shall mean an assay for determining whether
a compound is an agonist or antagonist to a Receptor or for determining the
functionality of a Receptor as described in U.S. Patent Application Serial No.
108,471, filed October 20, 1987.
1.11 The term "Useful Assay Improvements" shall mean developments in assay
techniques which are useful in assays for or using Receptors and which also may
be used in assays having non-Receptor related applications.
ARTICLE 2 - LICENSE GRANT
2.1 With respect to developments made in the laboratory of Xx. Xxxxx
included within 1.1(A) and (B) above, SALK hereby grants to LIGAND a worldwide
right and license, with the right to grant sublicenses, under its Patent Rights
and Know-How to make, have made, use and sell commercial products and services
which embody or which are obtained by using the screening method included in the
Technology and to make, have made, use and sell pharmaceutical products and
services which embody or which are obtained by using Receptors included in the
Technology, and with respect to developments made in the laboratory of Xx. Xxxxx
through October 20, 1993, to the
3
extent not included in the above, a worldwide right and license with the right
to grant sublicenses, under its other Patent Rights and Know-How limited to the
discovery and development of molecules that modulate the activity of Receptors
in humans, animals, insects and plants for therapeutic and growth regulatory
applications and to make, have made, use and sell therapeutic or growth
regulatory products which are so obtained, which rights and licenses shall be
exclusive except for a nontransferable right previously granted to SIBIA (the
Salk Institute Biotechnology/ Industrial Associates, Inc.) to use a cDNA clone
encoding the human glucocorticoid receptor internally within its organization, a
copy of which Agreement appears as Attachment 1 to this Agreement. It is
expressly understood that this license does not extend to the use of Useful
Assay Improvements for non-Receptor related applications.
2.2 SALK and HHMI each reserve the right under the Patent Rights and Know
How to use the Technology and to license others thereunder to use the Technology
for research purposes only.
ARTICLE 3 - [INTENTIONALLY OMITTED]
ARTICLE 4 - PAYMENTS TO SALK
4.1 In consideration of the rights granted by SALK to LIGAND under Article
2 and the right of first refusal granted under Article 3, LIGAND shall make
payments to SALK as specified in this Article 4.
4.2 LIGAND shall pay SALK a one-time, nonrefundable license issue fee
(technology acquisition fee) of $300,000. The fee will be paid in three
installments of $100,000 each, the first due and payable on October 20, 1988,
the second due and payable on or before October 20, 1989, and the third due and
payable on or before October 20, 1990.
4.3 As provided in subsequent provisions of this Article 4, LIGAND shall
pay SALK (a) either (i) a specified sum as a paid-up royalty for each Licensed
Product as provided in Paragraph 4.8 or (ii) a royalty on the Net Sales of
Licensed Products by LIGAND as provided in Paragraphs 4.4 and 4.7, and (b) a
share of any income, in excess of Fully Burdened Costs, LIGAND receives from
performance of any Licensed Services as provided in Paragraph 4.6 and (c) a
share of payments from third parties (other than from Net Sales of Licensed
Products or income for performance of Licensed Services), for example, a payment
made by a sublicensee for a paid-up license, royalties on a sublicensee's sales
of Licensed Products, income from a sublicensee's performance of Licensed
Services, etc., as provided in Paragraph 4.5.
4.4 The royalty on LIGAND Net Sales of Licensed Products shall depend upon
whether the Licensed Product is obtained as a result of or directed to a
receptor developed by SALK or a receptor developed by LIGAND. The applicable
royalty rate shall be in accordance with the table below:
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AGGREGATE
NET SALES
LICENSED ROYALTY RATE ROYALTY RATE
PRODUCTS SALK RECEPTOR LIGAND RECEPTOR
-------- ------------- ---------------
$0 - $200M 6% 4%
$200 - $400M 4% 2%
$400 - $600M 2% 1%
> $600M 1% 0.5%
4.5 (a) LIGAND shall pay to SALK fifty percent (50%) of all royalties it
receives from any sublicense or other agreement with a third party for the use
of the Technology by the third party and/or the sales by the third party of a
pharmaceutical or other product identified by use of the Technology except in
the circumstance where LIGAND has previously exercised its right to acquire a
fully paid-up license under Paragraph 4.8 covering the affected product. If the
sublicense or other agreement includes LIGAND's technology together with the
Technology, the parties will, in good faith, determine the extent of LIGAND's
contribution to the overall technology licensed and will reduce the percentage
of royalties to be paid to SALK accordingly, provided, however, that the
percentage of the royalties received from any sublicense or other agreement with
a third party and paid to SALK shall never fall below twenty-five percent (25%).
(b) Commencing on January 1, 2002, LIGAND shall pay to SALK twenty-five
percent (25%) of all upfront or technology access fees, product milestone
payments (whether research, preclinical or developmental) and other
remuneration, however characterized (except for direct reimbursement of research
expenditures actually incurred), it receives from any sublicense or other
agreement with a third party for the use of the Technology by the third party
and/or the sale by a third party of a pharmaceutical or other product identified
by use of the Technology except in the circumstance where LIGAND has previously
exercised its right to acquire a fully paid-up license under Paragraph 4.8
covering the affected product.
(c) Amounts due SALK under this Paragraph 4.5 shall be paid by LIGAND
within thirty (30) days of its receipt of the fees, royalties, milestones or
other remuneration to which such payments to SALK relate. In no event shall SALK
be due any payment under this Paragraph 4.5 in relation to amounts covered under
Paragraph 4.6 (e.g., research or FTE based funding).
(d) If a written agreement between LIGAND and a third party obligates such
third party to pay royalties to LIGAND under an arrangement described in
Paragraph 4.5(a) above and provides further that such royalties are to be offset
against prior milestone payments made by such third party to LIGAND, SALK shall
be entitled to receive only its share of such royalties as LIGAND actually
receives.
(e) LIGAND shall use its reasonable efforts to provide SALK a copy of each
third party agreement entered into by LIGAND as well as all modifications
thereof within sixty (60) days of entering into each such agreement and
modification (or promptly following execution and delivery of this Amended and
Restated License Agreement in such cases where LIGAND has not
5
heretofore delivered unredacted versions of such agreements and modifications to
SALK); provided, however, the foregoing obligations shall not be construed to
obligate LIGAND to breach its written obligations of confidentiality to such
third parties. LIGAND shall use its reasonable efforts (i) to avoid the
acceptance of contract terms that would preclude the delivery of third party
agreements and modifications to SALK and (ii) where existing written agreements
prohibit their delivery to SALK, to obtain the consent of appropriate third
parties to the delivery of such agreements to SALK. Furthermore, LIGAND shall
notify SALK promptly in writing of the receipt of any upfront or technology
access fee, royalty, milestone payment or other remuneration, however
characterized (except for direct reimbursement of research expenditures actually
incurred) received from a third party in connection with the development or sale
of products or the offering or sale of services for which SALK is entitled to
receive payment pursuant to this Paragraph 4.5. Such notice shall identify the
payer, the amount, the agreement pursuant to which such payment was received,
and, to the extent not prohibited by such agreement, such other information as
SALK may reasonably request.
(f) For the avoidance of doubt, Droloxifene shall be deemed outside the
scope of any royalty, milestone or other payment provisions set forth in this
Agreement. In addition, promptly following the effective date of this Amended
and Restated License Agreement, LIGAND shall deliver to SALK such technical
information in the possession of LIGAND, or which LIGAND may acquire without
undue expense as SALK may reasonably request, with respect to compounds known as
TSE424, ERA 923 and GW544 (the "Compounds"). Following receipt by SALK of all
such requested information pertaining to the Compounds, SALK shall be entitled
to select, in its sole discretion, two of the Compounds for inclusion within the
scope of this Agreement. Following selection, which shall occur no later than
one hundred eighty (180) days following the delivery of the technical
information described above, such two of the Compounds shall be deemed to have
resulted from the use of the Technology. The remaining member of the Compounds
shall be deemed as not having resulted from the use of the Technology.
4.6 Effective October 20, 1990, LIGAND shall pay to SALK ten percent (10%)
of any income it receives from performance of any Licensed Service in excess of
its Fully Burdened Costs for the service.
4.7 Beginning in the year 1991, LIGAND will pay SALK a minimum annual
royalty. The minimum annual royalties shall be due in the amounts shown in the
table below:
MINIMUM
YEAR ANNUAL ROYALTY
---- --------------
1991 $50,000
1992 $75,000
1993 $125,000
1994 $150,000
1995 $170,000
1996 $180,000
1997 $190,000
1998 and thereafter $200,000
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The minimum annual royalty payment shall become due and payable on the
sixtieth (60th) day following the end of the applicable year. Actual royalties
or other payments made to SALK by LIGAND as provided in Paragraphs 4.4 through
4.6 during the year in question will be creditable against the minimum annual
royalty accruing for that year. The obligation to pay a minimum annual royalty
shall not extend beyond the period for paying a royalty as provided in Paragraph
4.8.
4.8 With respect to each Licensed Product developed during the term of this
Agreement, LIGAND shall have the option of either (a) obtaining a paid-up
license with respect to the Licensed Product by paying to SALK at the time of
filing with the FDA an appropriate application, for example an NDA, for approval
to market the Licensed Product a fixed sum equal to $240,000 if the Licensed
Product is directed to or obtained as a result of a receptor developed by SALK
and/or $160,000 if the Licensed Product is directed to or obtained as a result
of a receptor developed by LIGAND, times the number of years from such filing to
the date of the last to expire of any patent included in the licensed Patent
Rights pertinent to the Licensed Product or (b) in lieu thereof, and solely for
the benefit of LIGAND, pay to SALK a royalty on Net Sales as specified in
Paragraph 4.4 above for an equivalent period of time starting from the date of
the first commercial sale of the Licensed Product, provided, however, that if
such royalty payments on Net Sales extend beyond the last to expire of all
licensed patents covering the Licensed Product, royalty payments shall not
exceed ten (10) years. LIGAND's right to obtain a paid-up license pursuant to
this paragraph 4.8 shall be exercisable within (i) thirty (30) days of the
filing by LIGAND with the FDA of an appropriate application, for example an NDA
or SNDA, for approval to market the Licensed Product or (ii) forty five (45)
days of the receipt by LIGAND of notice that a LIGAND sublicensee filed with the
FDA an appropriate application, for example an NDA or SNDA, for approval to
market the Licensed Product (receipt by LIGAND of such notice shall be deemed to
have occurred on the earlier of the date of receipt of actual written notice by
LIGAND from its sublicensee, the date of publication of such filing (whether in
a general circulation publication or an agency publication) or the date of a
press release made by LIGAND's sublicensee). From and after the effective date
of this Amended and Restated License Agreement, LIGAND shall use its reasonable
efforts to obtain the agreement of its sublicensees to provide LIGAND notice of
such sublicensees' filings with the FDA an appropriate application, for example
an NDA or SNDA, for approval to market the Licensed Product within fifteen (15)
days of their occurrence.
4.9 The payments referred to in Paragraphs 4.4 through 4.6 shall be made
semiannually and be accompanied by a report of the sales or other income which
generate the payment obligation in accordance with the provisions of Article 8
of this Agreement.
4.10 Notwithstanding anything in this Agreement to the contrary, with
respect to royalties required to be paid under Paragraphs 4.4 and 4.6 above,
starting with the eleventh (11th) year following October 20, 1988, royalties on
Licensed Products and Licensed Services shall be payable only to the extent that
such Licensed Products or Licensed Services are within the scope of a claim
included in the Patent Rights. Further, no royalty obligation for sales of a
Licensed Product or Licensed Service shall arise,
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based on a claim in a patent application which has been pending for more that
six (6) years; provided, however, that the royalty obligation shall resume if
such pending application is subsequently issued. The pendency of a continuing
application, including that portion of any continuation-in-part application
which is common to its parent application, and divisionals, shall be calculated
from the filing date of its oldest parent application.
4.11 No royalty need be paid by LIGAND to SALK with respect to
standardization or control assays performed by LIGAND which yield no
contribution to Net Sales.
4.12 Beginning as of August 30, 1988, LIGAND shall reimburse Salk for the
costs of filing, prosecuting and maintaining patent applications and patents
(hereinafter referred to as the "Patent Costs") included in said Patent Rights.
SALK will invoice LIGAND for such costs on a semiannual basis, and LIGAND shall
pay these Patent Costs within thirty (30) days after receiving each such
invoice. As to any newly filed U.S. patent application, LIGAND may, within
thirty (30) days of its receipt of such newly filed U.S. patent application,
elect to include or not include such application within the Patent Rights and if
it elects not to include such U.S. application within the Patent Rights then no
reimbursement under this Paragraph 4.12 will be required with respect to any
such U.S. application or any foreign counterparts thereof and LIGAND shall have
no right or license under such U.S. application, any foreign counterparts
thereof and any patents which issue thereon. As to any existing U.S. or foreign
patent application or patent, LIGAND may elect at any time to discontinue
support of any such application or patent, and upon such election LIGAND will
have no further right or license under such application or patent. SALK will
make available to LIGAND any substantive communication from the United States or
any foreign patent office concerning any patent application within the Patent
Rights and any proposed response thereto in order to permit LIGAND to comment
upon such response.
Within ten (10) days after the effective date of this Amended and Restated
License Agreement, LIGAND shall pay to SALK sixty one thousand two hundred
eighty eight dollars and six cents ($61,288.06) as reimbursement to SALK for its
actual expenses for prosecuting patent applications in the GAL-4 Patent Family
that are licensed to LIGAND pursuant to Paragraph 2.1 of this Agreement.
4.13 All Patent Costs paid by LIGAND hereunder shall be considered as an
advance against earned royalties payable pursuant to Paragraph 4.4 hereof.
LIGAND, however, may credit such Patent Costs only against those royalties
payable in any year which are in excess of the minimum royalties called for in
Paragraph 4.7 of this Agreement. Notwithstanding the foregoing, Patent Costs
incurred up to October 1, 1990 shall alternatively be considered an advance
against payments to be made under Paragraph 4.6 and Patent Costs incurred
subsequent to October 1, 1990, shall not constitute an advance against earned
royalties under Paragraph 4.4 or payments under Paragraph 4.6.
8
4.14 In consideration of the rights granted by SALK to LIGAND under Article
2 and the entry by SALK into the Third Amendment to License Agreement, LIGAND
(i) shall pay SALK $200,000 in three (3) installments of $75,000, $75,000 and
$50,000 respectively, the first due and payable on execution by both parties of
the Third Amendment to License Agreement and thereafter on October 20, 1991 and
October 20, 1992, and (ii) upon execution of the Third Amendment to License
Agreement, shall transfer to SALK 75,000 shares of Series B Preferred stock in
LIGAND.
4.15 (a) In consideration of the rights granted by SALK to LIGAND under
Article 2 and the execution by SALK of this Amended and Restated License
Agreement, LIGAND shall pay SALK, within ten (10) days of the execution of this
Amended and Restated License Agreement, the sum of two million five hundred
thousand dollars ($2,500,000) in cash by wire transfer to such account as is
designated by SALK no less than three (3) business days prior to the date on
which such payment is due.
(b) In consideration of the payment set forth in this Paragraph 4.15 and
the other mutual and respective promises and covenants set forth herein, SALK
hereby releases and discharges LIGAND, and LIGAND hereby releases and discharges
SALK, from any and all actions, claims, demands, suits, debts, liens, contracts,
agreements, promises, liabilities, damages, losses, costs or expenses of any
nature whatsoever, known or unknown, contingent or non-contingent, anticipated
or unanticipated, which either of them ever had, or now has against the other
under, in connection with, or in respect of this Agreement. Each of the parties
acknowledges that it has had the opportunity to review this Agreement with legal
counsel and is familiar with the provisions of California Civil Code ss. 1542,
which provides as follows:
A general release does not extend to claims which the creditor
does not know or suspect to exist in his favor at the time of
executing the release, which if known by him must have materially
affected the settlement with the debtor.
Each of the parties recognizes and understands that this section applies to
and covers the aforementioned claims and hereby expressly waives any rights it
may have under this section as well as under any other statutes or common law
principles of similar effect.
ARTICLE 5 - COMMERCIALIZATION
5.1 LIGAND will diligently seek to develop Licensed Products. LIGAND will
be deemed to have used its reasonable best efforts and met its diligence
obligations if, starting in year one, it expends at least $500,000 per year in
developing and/or in exploiting the licensed Technology and meets the following
milestones on the designated anniversaries of October 20, 1988:
9
MILESTONE ANNIVERSARY OBJECTIVE
--------- ----------- ---------
1. Third Commercial Screening System Developed
2. Fifth Candidate Drug(s) Identified
3. Seventh IND(s) Filed
4. Tenth NDA(s) Filed
5.2 If LIGAND fails to meet any of the milestones set forth in Paragraph
5.1 for any reason other than its failure to use its reasonable best efforts
(for which SALK may terminate this Agreement pursuant to Paragraph 5.3), SALK
shall have the option to convert this Agreement to a nonexclusive license. The
nonexclusive license shall be subject to a "most favorable license" provision in
favor of LIGAND.
5.3 In the event LIGAND shall fail to use its reasonable best efforts as
defined in Paragraph 5.1, SALK's sole and exclusive remedy in law and equity for
LIGAND's failure to comply with Paragraph 5.1 shall be the right to terminate
this Agreement pursuant to the provisions of Article 11.
ARTICLE 6 - TRANSMISSION OF INFORMATION AND KNOW-HOW
6.1 SALK agrees to provide LIGAND with copies of all published reports,
manuscripts accepted for publication and all other publications emanating from
SALK which relate to the Technology. Further information and Know-How will be
provided to LIGAND from time to time through scientific discussions and meetings
between LIGAND and SALK.
6.2 SALK further agrees to provide LIGAND with copies of all U.S. patent
applications which it files and which are included in the Patent Rights. SALK
further agrees to advise LIGAND regarding all patents which may issue and are
included in the Patent Rights.
6.3 Upon request, and when it does not interfere with the work being
carried out in Xx. Xxxxx' laboratory, SALK agrees to provide LIGAND with small
samples of biological materials, useful in LIGAND's Receptor-related research
activities, where such biological materials are not available from other
sources. LIGAND shall pay SALK a nominal amount to cover the reasonable cost of
providing such biological materials.
6.4 The parties intend that no contact or discussions relating to the
subject matter of this License Agreement initiated by LIGAND shall be made with
the scientists working in the laboratory of Dr. Xxxxxx Xxxxx except with the
prior approval of Xx. Xxxxx.
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ARTICLE 7 - CONSULTING
LIGAND and Xx. Xxxxx intend to enter into a consulting agreement under
which Xx. Xxxxx will consult with LIGAND in the development of Licensed Products
and Licensed Services. The terms of such consulting agreement must be acceptable
to both SALK and HHMI.
ARTICLE 8 - REPORTS AND RECORDS
8.1 Within sixty (60) days after the end of each semiannual period, during
the term of this Agreement and for so long thereafter as payments are due SALK
hereunder, LIGAND shall render a written report showing a breakdown of income
from sales of Licensed Products and Licensed Services by LIGAND and its
sublicensees and all payments received from third parties for the use of the
Technology and for sales of products identified by use of the Technology, and a
computation of sums due SALK for that semiannual period under Article 4 of this
Agreement, and shall simultaneously pay said sums.
8.2 Except as SALK may otherwise instruct LIGAND under Paragraph 8.3, all
amounts payable hereunder by LIGAND to SALK shall be payable in United States
currency in San Diego, California.
8.3 Royalties on the Net Sales of Licensed Products and Licensed Services
shall accrue and be computed in the currency of the country in which such sales
shall have been made by LIGAND and/or its sublicensees and such royalties and,
to the extent applicable any other payment due SALK hereunder, shall be payable
by LIGAND, according to instructions by SALK, in the United States in United
States Dollars, using as the rate of exchange the prevailing official buying
price in United States Dollars paid in New York, New York, U.S.A., for a
banker's check drawn in the currency involved on banks abroad in the country
involved, at the applicable rate of exchange at the date of remittance or on the
last day of the sixty (60) day period mentioned in Paragraph 8.1 above,
whichever is earlier.
8.4 LIGAND and its sublicensees shall maintain full, true and accurate
books of account and other records containing all particulars which may be
required to ascertain and verify the sums payable by it under this Agreement.
Said books, records and all supporting data shall be available at all reasonable
times and for a period of three (3) years following the period of reporting or
for a period consistent with generally acceptable accounting procedures,
whichever is longer, and shall be open to the inspection of an accountant from
the Accounting Department of SALK or an independent certified accountant
retained by SALK for the purpose and to whom LIGAND has no reasonable objection;
provided, however, that such accountant shall report to SALK only as to the
accuracy of the written report and payments. This accountant will be obliged to
treat as confidential all relevant matters and may disclose to SALK management
only whether there is an error and the amount of the error, if any. In the event
of disagreement between the accountant and LIGAND as to the accuracy of the
written report and/or payments, additional information shall be provided by
LIGAND to SALK; however, such
11
information shall be of such a nature and in an amount sufficient only to effect
resolution of the disagreement. The expense of any audit shall be borne by SALK;
provided, however, if the audit discloses an error benefiting LIGAND, then
LIGAND shall pay, in addition to the amount of the error found, an amount for
such audit equal to the amount of the error found but not to exceed the cost to
SALK of the audit.
8.5 For the purposes of identifying relevant patents and computing the
terms thereof for the computation of royalties or the paid-up license pursuant
to Paragraph 4.8 of this Agreement, LIGAND shall use commercially reasonable
efforts to provide to SALK, following the filing of an NDA or SNDA, relevant
information relating to the applicable Licensed Product then within LIGAND's
control, and not subject to legal restrictions that would prevent the disclosure
of such information to SALK hereunder.
ARTICLE 9 - INFRINGEMENT OF PATENT RIGHTS
9.1 SALK shall have the first right to prosecute third parties for
infringement of a patent licensed to LIGAND under this Agreement and shall
retain any award of damages, attorney's fees or costs. In the event SALK does
not file an action for infringement or cause such infringement to terminate
within ninety (90) days from the date on which it first learns of such
infringement, LIGAND shall have the right to bring such suit and to name SALK as
a plaintiff if necessary to maintain the action. In the case of LIGAND bringing
a suit, it shall have the right to credit its litigation expenses against fifty
percent (50%) of the royalties payable hereunder, including minimum royalties or
other payments accruing to SALK under Paragraphs 4.4 through 4.8. In the event
LIGAND receives any cash award in such an action or as a result of settlement
thereof, it shall pay to SALK an amount equal to the aggregate credit that was
taken against royalties or other payments accruing to SALK; it shall then deduct
its litigation expenses, and the remainder, if any, shall be divided equally
between SALK and LIGAND. If both SALK and LIGAND decline to bring an
infringement suit, LIGAND shall be entitled to suspend its royalty payments with
respect to the patent being infringed until such time as SALK elects to xxx the
infringer; provided, however, that if LIGAND elects not to xxx the infringer
within ninety (90) days after SALK gives written notice that it declines to
bring suit, SALK may grant the infringer a nonexclusive license under the patent
being infringed, after which royalty payments shall no longer be suspended by
LIGAND. If such nonexclusive license has a royalty or other payment term more
favorable than granted LIGAND in this Agreement, LIGAND shall be accorded the
benefit of such more favorable term.
9.2 If LIGAND or a sublicensee, in exercising its rights under this
Agreement, is sued for infringement of a patent by a third party for an act
which, but for practice or use of the Technology would not infringe the rights
of the third party, LIGAND may credit its expenses in defense or settlement of
such infringement against fifty percent (50%) of royalties payable hereunder,
including minimum royalties, or other payments accruing under this Agreement.
9.3 If additional technology is necessary to commercialize the Technology,
then LIGAND may credit any royalty paid a third party on sales of Licensed
Products or
12
Licensed Services in an amount not to exceed fifty percent (50%) of the royalty
or other payments, other than the minimum royalty accruing under this Agreement,
such credits being limited to royalties accruing upon the affected product or
service.
9.4 SALK and LIGAND shall each give prompt written notice to the other of
any infringement of the Patent Rights by third parties as may come to its
knowledge.
ARTICLE 10 - TERM
The term of this Agreement shall extend to the end of the last to expire of
any patent included in said Patent Rights, or the extended period which may be
selected by LIGAND for the payment of royalties, whichever is later, unless
terminated at an earlier date pursuant to another provision of this Agreement.
ARTICLE 11 - TERMINATION
11.1 LIGAND may terminate this Agreement at the end of any calendar year
upon sixty (60) days prior written notice to SALK thereof.
11.2 If LIGAND shall be declared bankrupt or insolvent, or shall apply for
any relief under any bankruptcy, insolvency, corporate reorganization or debtor
relief laws of the United States or any state thereof, or have a receiver
appointed, or shall commence proceedings to dissolve, or suffer such attachments
or execution as shall prevent manufacturing or selling operations of LIGAND for
sixty (60) days, such act or event shall constitute a material breach of this
Agreement and shall, without any further notice by SALK, cause an automatic
termination of this Agreement.
11.3 If LIGAND shall breach any of the terms of this Agreement or otherwise
be in default hereunder and shall not cure such breach or default with thirty
(30) days after written notice thereof to LIGAND, then SALK, in addition to any
other remedies available to it in law or equity, may by written notice to LIGAND
terminate this Agreement forthwith. Failure to terminate this Agreement for any
breach shall not be construed as a waiver of the right to do so for any
continuation or repetition of said breach, or for any subsequent breach of the
same or dissimilar nature.
11.4 In the event of termination of this Agreement, LIGAND shall not be
relieved of any duty and obligation which may have accrued prior to the
effective date of such termination to pay royalties and/or make any other
payments.
11.5 On termination of this Agreement for any reason, all rights hereunder
shall revert to SALK for the benefit of SALK, and all technical information in
documentary form obtained from SALK, and all copies of it, shall be promptly
returned to SALK except that LIGAND shall be permitted to retain copies where
required to do so by reason of any statute, ordinance or regulation of any
federal, state or local governmental entity.
13
ARTICLE 12 - SURVIVAL OF RIGHTS
The provisions of Article 15 concerning confidentiality and Article 17
concerning disclaimer of liability and indemnification shall survive the
termination of this Agreement, Article 15 for a period of three (3) years, and
Article 17 without limit.
ARTICLE 13 - AGENCY
LIGAND shall not be deemed to be an agent of SALK as a result of any
transaction under or related to this Agreement, and shall not in any way pledge
SALK's credit or incur any obligation on behalf of SALK.
ARTICLE 14 - USE OF SALK'S NAME
14.1 LIGAND shall not have the right to publicize the Letter of Intent,
this Agreement or its relationship with SALK without SALK's written approval
except as provided in Paragraph 14.2 and as required to comply with federal or
state laws or regulations.
14.2 SALK agrees that LIGAND may make it known in promotional and technical
literature that the Technology was invented by Xxxxxx X. Xxxxx and other SALK
scientists; that Xx. Xxxxx is affiliated with the HHMI Gene Expression
Laboratory, The Salk Institute for Biological Studies; and that Licensed
Products and Licensed Services are offered under license from SALK; provided,
however, that such use shall not state or imply that SALK has any relationship
with LIGAND other than as licensor-licensee.
ARTICLE 15 - NONDISCLOSURE OF CONFIDENTIAL INFORMATION
All confidential scientific, technical, and business information related to
the Technology communicated by one party hereto to the other, including
information contained in patent applications, shall be kept confidential by the
recipient, which shall take all reasonable steps to ensure that such
confidential information does not pass negligently or otherwise into the hands
of those unauthorized to receive it. Notwithstanding the foregoing, a party
hereto shall be relieved of such confidentiality obligations and not be
prevented from disclosing any information received by it from the disclosing
party if (a) the information was previously known to the recipient; (b) the
information is or becomes generally available to the public through no fault of
the recipient, including as a result of publications and/or laying open to
inspection of any patent applications that the disclosing party may file; (c)
the information is acquired in good faith in the future by the recipient from a
third party who is not under an obligation of confidence to the disclosing party
in respect to such information; or (d) after October 20, 1988, the disclosure of
such information in the hands of LIGAND is reasonably considered necessary for
the commercial exploitation of the license granted under this Agreement. The
foregoing shall not be construed to prevent SALK from disclosing to HHMI
confidential scientific, technical or
14
business information related to the Technology provided such information is
related to Technology in which HHMI has an interest.
ARTICLE 16 - WARRANTY
16.1 SALK hereby represents and warrants that SALK has valid title in and
to the Patent Rights and has the right to license same to LIGAND pursuant to the
terms of this Agreement.
ARTICLE 17 - DISCLAIMER OF LIABILITY AND INDEMNITY
17.1 SALK shall exercise reasonable care in verifying the accuracy of
information provided under this Agreement, but SALK shall not be liable for any
damages arising out of or resulting from any information made available
hereunder or of the use thereof nor shall it be liable to LIGAND for special,
incidental or consequential damages under any circumstances.
17.2 SALK shall have no responsibility for the ability, of LIGAND to use
such information, the quality or result of any service rendered by LIGAND with
the aid of such information, or with respect to claims of third parties arising
from LIGAND's use of such information.
17.3 LIGAND shall assume all responsibility for the use of information
supplied to it by SALK or otherwise obtained by LIGAND pursuant to this
Agreement.
17.4 Nothing in this Agreement shall be construed as:
(a) a warranty or representation by SALK as to the validity or scope
of any of the Patent Rights; or
(b) a warranty or representation by SALK that anything made, used or
sold or otherwise disposed of under any license granted in this Agreement is or
will be free from infringement of patents of third parties; or
(c) an obligation of SALK to bring or prosecute actions or suits
against third parties for infringement, except as expressly set out in Article
9; or
(d) conferring the right to use in advertising, publicity or otherwise
any trademark, trade name, insignia or name, or names, or any contraction,
abbreviation, adaptation thereof, of SALK, except as expressly set out in
Article 14; or
(e) an obligation of SALK to furnish any know-how not provided for in
this Agreement.
17.5 All property, whether tangible or intangible, which may be delivered
hereunder shall be delivered on an "as is" basis. Except as expressly stated in
Article 16
15
of this Agreement, NO WARRANTIES OF ANY KIND, WHETHER STATUTORY, WRITTEN, ORAL,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR USAGE SHALL APPLY.
17.6 LIGAND hereby indemnifies, holds harmless, and agrees to defend SALK
and HHMI, and their trustees, officers, employees, and agents from any loss,
claim, damage or liability, of whatsoever kind or nature, which may arise at any
time out of or in connection with any activity of LIGAND under this Agreement or
involving the Technology or any information furnished hereunder, including
without limitation the use, handling, storage, distribution, containment, sale
and/or disposition of any product, or provision of any service, related to or
derived directly or indirectly from or using said Technology.
ARTICLE 18 - INSURANCE
During the term of this Agreement and for so long thereafter as is
reasonably deemed necessary by LIGAND to support its indemnity obligation under
Article 17 hereof, LIGAND shall maintain adequate comprehensive general
liability insurance with full coverage for claims of bodily injury and property
damage related to any product or service affected by this Agreement or based
upon reliance upon a representation or warranty made at any time with respect to
any such product or service. Evidence of such insurance shall be furnished by
LIGAND to SALK upon request.
ARTICLE 19 - FORCE MAJEURE
If the performance of any obligation hereunder of either of the parties is
prevented, restricted or interfered with by reason of fire, explosion, strike,
labor dispute, casualty or accident, lack or failure of transportation
facilities, flood, war, civil commotion, acts of God, any law, order or decree
of any government or subdivisions thereof or any cause whatsoever, whether
similar or dissimilar to those above enumerated, beyond the reasonable control
of the party (hereinafter referred to as an "event of force majeure"), the party
so affected shall, upon giving notice to the other party, be excused from
performance hereunder to the extent and for the duration of such prevention,
restriction or interference. If such event of force majeure continues for a
period of ninety (90) days, then either party may, at any time thereafter, by
giving written notice to the other party, terminate this Agreement. The term of
this Agreement or any renewal thereof shall not be extended by an event of force
majeure.
ARTICLE 20 - ASSIGNMENT
Neither this Agreement nor any of the rights or obligations hereunder may
be assigned by either party without the prior written consent of the other
party, except that LIGAND shall have the right to assign this Agreement in any
transaction constituting the purchase of the business of LIGAND to which this
Agreement pertains or to the surviving entity of any merger involving
16
LIGAND or of any acquisition of LIGAND. This Agreement shall inure to the
benefit of and be binding upon the parties and their respective successors and
permitted assigns.
ARTICLE 21 - APPLICABLE LAW AND ARBITRATION
21.1 This Agreement and its effect are subject to and shall be construed
and enforced in accordance with the laws of the State of California, United
States of America.
21.2 If a dispute arises out of or relates to this Agreement, or the breach
hereof, the parties agree first to try in good faith to settle the dispute by
mediation under the Commercial Mediation Rules of the American Arbitration
Association, before resorting to arbitration. Thereafter, any remaining
unresolved controversy or claim arising out of or relating to this Agreement, or
breach hereof, shall be settled by arbitration in accordance with the Commercial
Arbitration Rules of the American Arbitration Association, and judgment upon the
award rendered by the arbitrator(s) may be entered in any court having
jurisdiction thereof. The seat of the arbitration shall be in San Diego,
California, U.S.A. and the decision of the arbitrators shall be final.
ARTICLE 22 - NONWAIVER
The waiver of either party hereto of any right hereunder or of the failure
to perform or of a breach by the other party shall not be deemed a waiver of any
other right hereunder or of any other breach or failure by said other party
whether of a similar nature or otherwise.
ARTICLE 23 - SEVERABILITY
Nothing in this Agreement shall be construed so as to require the
commission of any act contrary to law. 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 effective provisions of this Agreement shall be
curtailed and limited only to the extent necessary to bring it within the
applicable legal requirements.
ARTICLE 24 - OFFICIAL NOTICES
24.1 Any notices required by this Agreement shall be sent by registered or
certified airmail, postage prepaid, or by Telex or cable, charges prepaid, and
shall be forwarded to the respective addresses set forth below:
17
FOR SALK: The Salk Institute for Biological Studies
P. O. Xxx 00000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: Xx. Xxxxx Xxxxxx
Vice President, Intellectual Property and
Technology Transfer
FOR LIGAND: Ligand Pharmaceuticals Incorporated
00000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: President
24.2 The address to which any notice, demand or other writing may be given
or made or sent to any party may be changed upon written notice given by such
party as above provided.
ARTICLE 25 - NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE
COMPETITION AND PATENT TERM RESTORATION ACT
25.1 SALK shall promptly notify LIGAND of (a) the issuance of each U.S.
patent included within the Patent Rights, giving the date of issue and patent
number for each such patent, and (b) each notice pertaining to any patent
included within the Patent Rights which it receives as patent owner pursuant to
the DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT, (the "Act"),
including but not necessarily limited to notices pursuant to Section 101 and 103
of the Act from persons who have filed an abbreviated NDA or a "paper" NDA.
25.2 SALK hereby authorizes LIGAND to include in any NDA for a Licensed
Product, as LIGAND may deem appropriate under the Act, a list identifying SALK
as patent owner of those patents included within the Patent Rights which relate
to such Licensed Product and such other information as may be required by
federal law or regulation. SALK agrees as patent owner under the Act to apply
for an extension of the term of any patent included within the Patent Rights, as
permitted by the Act, upon request by LIGAND.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
18
ARTICLE 26 - ENTIRE AGREEMENT
This Agreement constitutes the entire agreement between the parties
relating to the subject matter hereof and all prior negotiations,
representations, letters of intent, agreements and understandings are merged
into, extinguished by, and completely expressed by this Agreement. The parties
acknowledge that this Agreement amends and restates the prior License Agreement
dated as of October 20, 1988, as amended pursuant to that certain Amendment to
License Agreement effective as of the 15th day of September, 1989, that certain
Second Amendment to License Agreement effective as of the first day of December,
1989 and that certain Third Amendment to License Agreement effective as of the
20th day of October 1990.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized representatives to be effective as of the day
and year first above written.
ATTEST: THE SALK INSTITUTE FOR
BIOLOGICAL STUDIES
/S/ILLEGIBLE By /S/XXXXX X. XXXXXX
----------------------------- -----------------------------
Assistant Secretary Title VP, IPTT
SEAL
ATTEST: LIGAND PHARMACEUTICALS INCORPORATED
/S/XXXXXXX X. XXXXX By /S/XXXX X. XXXXX
----------------------------- -----------------------------
Assistant Secretary Title SENIOR VP, CFO
SEAL
19
ATTACHMENT 1
AGREEMENT BETWEEN
THE SALK INSTITUTE FOR BIOLOGICAL STUDIES
(SALK)
AND
THE SALK INSTITUTE BIOTECHNOLOGY/INDUSTRIAL ASSOCIATES, INC.
(COMPANY)
Date: 8/28/85
A cDNA clone encoding the entire human glucocorticoid receptor, designated as
OB107, will be made available to COMPANY subject to the following terms:
1. The clone proper will not be distributed to any person, laboratory or
other entity, commercial or otherwise, external to COMPANY's
organization.
2. Except as provided in Paragraph 1 above, the clone may be used by
COMPANY for its commercial purposes in any manner whatsoever.
3. In lieu of a fee, COMPANY will provide to SALK reasonable quantities
of an expression vector containing the clone and/or protein expressed
by said expression vector containing the clone, as SALK may request
from time to time.
4. In all COMPANY publications related to the use of the subject clone,
the designation above will be employed.
5. THE CLONE IS PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED,
AND UNDER THE CONDITION THAT SALK AND ITS EMPLOYEES AND AGENTS HAVE NO
LIABILITY IN CONNECTION WITH SUCH CLONE OR ITS USE. COMPANY HEREBY
AGREES TO WAIVE ALL CLAIMS AGAINST SALK, AND TO DEFEND AND INDEMNIFY
SALK FOR ALL CLAIMS AND DAMAGES ASSERTED BY THIRD PARTIES, ARISING
FROM THE USE, STORAGE AND HANDLING OF THE CLONE BY COMPANY.
If the foregoing terms are acceptable, a duly authorized representative of
COMPANY should sign two copies of this Agreement where indicated and return one
copy to SALK. Upon receipt of the signed copy, SALK will arrange for prompt
shipment of the clone to COMPANY.
THE SALK INSTITUTE FOR
BIOLOGICAL STUDIES
By
-----------------------------------
VICE PRESIDENT OPERATIONS
-----------------------------------
Title
THE SALK INSTITUTE BIOTECHNOLOGY/
INDUSTRIAL ASSOCIATES, INC.
(COMPANY)
By /S/
-----------------------------------
EXEC. V.P.
-----------------------------------
Title
2
SCHEDULE A
INTRACELLULAR STEROID AND STEROID-LIKE RECEPTORS
***
U.S. Serial No. 108,471, filed October 20, 1987, now U.S. Patent No. 5,071,773,
issued December 10, 1991. Inventors: X. Xxxxx et al. CIP of U.S. Serial No.
922,585.
HORMONE RECEPTOR-RELATED BIOASSAYS.
U.S. Serial No. 667,602, filed March 7, 1991, now U.S. Patent No. 5,312,732,
issued May 17, 1994. Inventors: X. Xxxxx et al. DIV of U.S. Serial No. 108,471.
HORMONE RECEPTOR COMPOSITIONS AND METHODS.
U.S. Serial No. 165,708, filed December 10, 1993, now U.S. Patent No. 5,597,705,
issued January 28, 1997. Inventors: X. Xxxxx, et al. DIV of U.S. Serial No.
667,602.
DNA ENCODING THYROID HORMONE RECEPTOR COMPOSITIONS AND METHODS.
***
***
***
U.S. Serial No. 166,177, filed December 10, 1993, now U.S. Patent No. 5,534,418,
issued July 9, 1996. Inventors: X. Xxxxx et al. DIV of U.S. Serial No. 667,602.
CONTROLLED EXPRESSION OF RECOMBINANT PROTEINS.
U.S. Serial No. 170,085, filed December 17, 1993, now U.S. Patent No. 5,606,021,
issued February 25, 1997. Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
667,602.
MINERALOCORTICOID COMPOSITIONS AND METHODS.
***
***
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
***
***
U.S. Serial No. 807,135, filed December 10, 1991, now U.S. Patent No. 5,298,429,
issued March 29, 1994. Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
108,471.
BIOASSAYS FOR IDENTIFYING ANTAGONISTS OF STEROID HORMONE RECEPTORS.
***
***
***
***
U.S. Serial No. 276,536, filed November 30, 1988, now U.S. Patent No. 4,981,784,
issued January 1, 1991, Inventors: X. Xxxxx et al. CIP of U.S. Serial No.
128,331.
RETINOIC ACID RECEPTOR COMPOSITION AND METHOD.
U.S. Serial No. 773,041, filed January 31, 2001, reissue of U.S. Patent No.
4,981,784. Inventors: X. Xxxxx et al.
CHIMERIC STEROID HORMONE SUPERFAMILY RECEPTOR PROTEINS.
U.S. Serial No. 546,256, filed August 6, 1990, now U.S. Patent No. 5,171,671,
issued December 15, 1992, Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
276,536.
RETINOIC ACID RECEPTOR COMPOSITION.
***
U.S. Serial No. 975,777, filed November 13, 1992, now U.S. Patent No. 5,274,077,
issued December 28, 1993, Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
546,256.
RETINOIC ACID RECEPTOR COMPOSITION.
U.S. Serial No. 845,857, filed March 3, 1992, now U.S. Patent No. 5,599,904,
issued February 4, 1997, Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
546,570.
CHIMERIC STEROID HORMONE SUPERFAMILY RECEPTOR PROTEINS.
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
U.S. Serial No. 168,686, filed December 16, 1993, now U.S. Patent No. 5,571,692,
issued November 5, 1996, Inventors: X. Xxxxx et al. CONT of U.S. Serial No.
845,857.
DNA ENCODING RETINOIC ACID RECEPTOR ALPHA, VECTORS AND CELLS COMPRISING THE
SAME.
U.S. Serial No. 179,912, filed January 11, 1994, now U.S. Patent No. 5,548,063,
issued August 20, 1996, Inventors: X. Xxxxx et al. CONT of U.S. Serial No.
845,857.
RETINOIC ACID RECEPTOR ALPHA PROTEINS.
***
U.S. Serial No. 370,407, filed June 22, 1989, now U.S. Patent No. 5,260,432,
issued November 9, 1993, Inventors: Takaku et al.
HUMAN GAMMA RETINOIC ACID RECEPTOR DNA.
U.S. Serial No. 100,039, filed July 30, 1993, now U.S. Patent No. 5,530,094,
issued June 25, 1996, Inventors: Takaku et al. DIV of U.S. Serial No. 370,407.
GAMMA RETINOIC ACID RECEPTOR.
U.S. Serial No. 486,325, filed June 7, 1995, now U.S. Patent No. 6,284,870,
issued September 4, 2001, Inventors: Takaku et al. DIV of U.S. Serial No.
100,039
GAMMA RETINOIC ACID RECEPTOR.
***
U.S. Serial No. 278,614, filed November 30, 1988, now U.S. Patent No. 5,217,867,
issued June 8, 1993. Inventors: X. Xxxxx, et al.
RECEPTORS: THEIR IDENTIFICATION, CHARACTERIZATION, PREPARATION, AND USE.
U.S. Serial No. 797,546, filed November 25, 1991, now U.S. Patent No. 5,262,300,
issued November 16, 1993. Inventors: X. Xxxxx, et al.
BIOASSAYS FOR IDENTIFYING ANTAGONISTS OF RECEPTORS OF THE STEROID/THYROID
SUPERFAMILY.
U.S. Serial No. 073,928, filed June 8, 1993, now U.S. Patent No. 5,310,662,
issued May 10, 1994. Inventors: X. Xxxxx, et al. DIV of U.S. Serial No. 278,614.
RECEPTORS: THEIR IDENTIFICATION, CHARACTERIZATION, PREPARATION, AND USE.
***
***
***
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
***
***
***
U.S. Serial No. 464,272, filed June 5, 1995, now U.S. Patent No. 5,688,691,
issued November 18, 1997. Inventors: Oro, et al. CONT of U.S. Serial No.
013,975.
INSECT RETINOID-LIKE RECEPTOR COMPOSITIONS AND METHODS.
U.S. Serial No. 464,266, filed June 5, 1995, now U.S. Patent No. 5,641,652,
issued June 24, 1997. Inventors: Oro, et al. DIV of U.S. Serial No. 013,975.
INSECT RETINOID-LIKE RECEPTOR COMPOSITIONS AND METHODS.
U.S. Serial No. 438,757, filed November 16, 1989, now U.S. Patent No. 5,091,518,
issued February 25,1992. Inventors: Sucov, et al.
BETA RETINOIC ACID RESPONSE ELEMENTS COMPOSITIONS AND ASSAYS.
***
***
U.S. Serial No. 346,342, filed November 28, 1994, now U.S. Patent No. 5,707,800,
issued January 13, 1998. Xxxxxxxxxxx, et al. CONT of U.S. Serial No. 671,044.
RESPONSE ELEMENT COMPOSITIONS AND ASSAYS EMPLOYING SAME.
***
U.S. Serial No. 494,618, filed March 16, 1990, now U.S. Patent No. 5,597,693,
issued January 28, 1997. X. Xxxxx et al. Filed via PCT as a CIP of U.S. Serial
No. 325,240.
HORMONE RESPONSE ELEMENT COMPOSITIONS AND ASSAY.
***
***
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
U.S. Serial No. 336,408, filed November 8, 1994, now U.S. Patent No. 5,723,329,
issued March 3, 1998. Xxxxxxxxxxx, et al. CONT of U.S. Serial No. 933,453.
DNA ENCODING RETINOID RECEPTOR X (RXR) ALPHA AND GAMMA; CORRESPONDING VECTORS
AND HOST CELLS.
***
***
U.S. Serial No. 030,330, filed May 3, 1994, now U.S. Patent No. 5,639,592,
issued June 17, 1997. Inventors: X. Xxxxx et al. Filed via PCT as a CIP of U.S.
Serial No. 586,187
FUNCTIONAL ANTAGONISM BETWEEN PROTO-ONCOPROTEIN C-JUN AND HORMONE RECEPTORS.
***
U.S. Serial No. 333,358, filed November 2, 1994, now U.S. Patent No. 5,571,696,
issued November 5, 1996. Inventors: X. Xxxxx et al. CONT of U.S. Serial No.
761,068.
RECEPTORS.
U.S. Serial No. 463,694, filed June 5, 1995, now U.S. Patent No. 5,696,233,
issued December 9, 1997. Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
333,358.
ORPHAN STEROID HORMONE RECEPTORS.
U.S. Serial No. 694,501, filed August 7, 1996, now U.S. Patent No. 5,710,004,
issued January 20, 1998. Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
333,358.
METHODS OF USING NOVEL STEROID HORMONE ORPHAN RECEPTORS.
***
***
U.S. Serial No. 695,743, filed August 12, 1996, now U.S. Patent No. 5,668,175,
issued September 16, 1997. Inventors: X. Xxxxx et al. CONT of U.S. Serial No.
748,767.
USE OF SELECTIVE LIGANDS FOR TREATMENT OF DISEASE STATES RESPONSIVE TO STEROID
OR STEROID-LIKE RETINOIDS.
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
U.S. Serial No. 931,694, filed September 16, 1997, now U.S. Patent No.
6,096,787, issued August 1, 2000. Inventors: X. Xxxxx et al. DIV of U.S. Serial
No. 695,743.
USE OF SELECTIVE LIGANDS FOR TREATMENT OF DISEASE STATES RESPONSIVE TO STEROID
OR STEROID-LIKE RETINOIDS.
***
***
***
***
U.S. Serial No. 475,174, filed June 7, 1995, now U.S. Patent No. 5,932,622,
issued August 3, 1999. Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
244,857.
METHOD FOR IN VIVO MODULATION OF SKIN RELATED PROCESSES.
***
***
U.S. Serial No. 472,817, filed June 7, 1995, now U.S. Patent No. 5,968,989,
issued November 19, 1999. Inventors: X. Xxxxx et al. DIV of U.S. Serial No.
244,857.
MEANS FOR THE MODULATION OF PROCESSES MEDIATED BY RETINOID X RECEPTOR.
***
***
***
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
***
***
U.S. Serial No. 486,403, filed June 5, 1995, now U.S. Patent No. 6,281,330,
issued August 28, 2001. Inventors: X. Xxxxx et al. CONT of U.S. Serial No.
907,908.
MULTIMERIC FORMS OF MEMBERS OF THE STEROID/THYROID SUPERFAMILY OF RECEPTORS WITH
THE ULTRASPIRACLE RECEPTOR.
U.S. Serial No. 464,514, filed June 5, 1995, now U.S. Patent No. 6,265,173,
issued July 24, 2001. Inventors: X. Xxxxx et al. DIV of U.S. Serial No. 907,908.
MULTIMERIC FORMS OF MEMBERS OF THE STEROID/THYROID SUPERFAMILY OF RECEPTORS WITH
THE ULTRASPIRACLE RECEPTOR.
***
***
***
***
***
***
U.S. Serial No. 484,200, filed June 7, 1995, now U.S. Patent No. 5,861,274,
issued January 19, 1999. Inventors: X. Xxxxx et al. CIP of U.S. Serial No.
270,643.
NUCLEIC ACIDS ENCODING PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR.
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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Description: Hormone Receptor Compositions and Methods
Serial # Status Patent#
---------- --------- ---------
108,471 ++++++++++++++++ 5,071,773
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Country Name Filing Type Application # Patent # Status Date Count
-------------------- ----------- --------------- ------------------ ------------- -------- -------
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Japan PCT 507128/87 1
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Austria EPC/PCT E182173 1
Belgium EPC/PCT 0287653 1
EPC EPC/PCT 87907643.8 0287653 10/23/2007 1
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933,453 Abandoned
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Xxxxx XXX 000000/00 0
Xxxxxx Xxxxxx PCT 933,453 1
EPC EPC/PCT 91 905 013.8 0514488 1
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Xxxxxx Xxxxxx PCT 030,330 1
Austria EPC/PCT 0 552 202 09/20/2011 1
Belgium EPC/PCT 0 552 202 09/20/2011 1
Denmark EPC/PCT 0 552 202 09/20/2011 1
EPC EPC/PCT 91 917 435.9 1
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Liechtenstein EPC/PCT 0 552 202 09/20/2011 1
Luxembourg EPC/PCT 0 552 202 09/20/2011 1
Netherlands EPC/PCT 0 552 202 09/20/2011 1
Spain EPC/PCT 0 552 202 09/20/2011 1
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Description: Novel Receptors
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Description: Use of Selective Ligands for Treatment of Hormone
Serial # Status Patent#
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Xxxxxx Xxxxxx PCT 193,146 1
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Denmark EPC/PCT 0 617 614 1
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803,163 Abandoned
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Canada PCT 2,121,800 1
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Denmark EPC/PCT 1
EPC EPC/PCT 93 900 894.2 1
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Ligand Pharmaceuticals - Intracellular Steroid and Steroid-like Receptors
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Ligand Pharmaceuticals - Intracellular Steroid and Steroid-like Receptors
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---------- --------- ---------
669,779 Pending
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SCHEDULE B
FULLY BURDENED COSTS
Such costs shall include without exception:
o Direct salaries and wages and related payroll taxes and fringe
benefits
o Direct materials and supplies
o Direct costs incurred for subcontracted services
o Allocated overhead costs*:
- purchasing department expenses
- quality assurance department expenses
- production related facilities, utilities, insurance, taxes and
maintenance
- depreciation of production related machinery, equipment and
improvements
o Freight, taxes and duties incurred in performing Licensed Services
o Other royalties required to be paid in connection with the performance
of Licensed Services
o Warranty charges specifically related to the provision of Licensed
Services
o Allocated general administrative expenses**:
- legal
- accounting
- selling and marketing expenses
- personnel
- property taxes and insurance
- officer salaries and benefits
* Overhead costs shall be allocated on the ratio of direct labor costs to
total labor costs.
** General and administrative costs shall be allocated based on the ratio of
total general and administrative costs to total direct and indirect costs.
