1
EXHIBIT 10.49
THE CONFIDENTIAL PORTION OF THIS CONTRACT HAS BEEN OMITTED PURSUANT TO
REGULATION 240.25B-2(B) OF THE SECURITIES EXCHANGE ACT OF 1934, AND HAS BEEN
FILED SEPARATELY WITH THE COMMISSION.
LICENSE AGREEMENT
This License Agreement ("Agreement") is entered into and effective
this 15 day of February, 1997, between Ribozyme Pharmaceuticals, Inc., a
Delaware corporation having its principal place of business in Boulder,
Colorado ("RPI"), and IntelliGene, an Israeli company having its principal
place of business in Jerusalem, Israel ("IntelliGene").
WHEREAS, RPI has developed or has licensed certain technology,
including patents, trade secrets, proprietary information and know-how,
relating to the design, synthesis and manufacture of ribozymes and the
application of ribozymes to the diagnosis of human diseases; and
WHEREAS, IntelliGene has developed certain technology, including
patents, trade secrets, proprietary information and know-how relating to
nucleic acid enzymes, and to diagnostic products and services, and proposes to
design, develop and commercialize in vitro diagnostics based on ribozymes; and
WHEREAS, the parties wish to enter into this Agreement for certain
licenses for IntelliGene's use of RPI's ribozyme technology in the Fields (as
defined herein), and sale of certain products and services using ribozymes, as
identified herein;
NOW, THEREFORE, the parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
The following capitalized terms shall have the meanings indicated for
purposes of this Agreement:
1.1 "Affiliate" shall mean any entity which controls, is
controlled by, or is under common control with, a party hereto. An entity shall
be regarded as being in control of another entity if such party owns or
controls, directly or indirectly, 50 percent or more of the shares of
1
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
2
the subject entity entitled to vote in the election of directors (or, in the
case of an entity that is not a corporation, for the election of the
corresponding managing authority).
1.2 "Alternative Suppliers" shall mean those suppliers subject to
a Supply License under Section 4.10 hereof or a similar license to manufacture
Ribozymes pursuant to any other manufacturing agreement between the parties.
1.3 "Amplified Nucleic Acid Formats" shall mean methods for
amplification of nucleic acids as specifically disclosed or encompassed within
IntelliGene Technology or RPI Technology.
1.4 "Collaborator" shall mean any non-Affiliate entity or person
engaged in an active collaboration with RPI for the purpose of developing,
enhancing or commercializing the use of Ribozymes.
1.5 "Commercial Sale" shall mean any transaction which transfers
to a purchaser physical possession and title to any Product, after which
transfer the seller has no right or power to determine purchaser's resale
price, if any, and any transaction which involves the performance of Licensed
Services for a third party after which no further related services are
performed. Transfer of possession and title to Product and/or Semi-Finished
Product to, or performance of Licensed Services for, an Affiliate or Corporate
Partner for purposes of resale by such Affiliate or Corporate Partner shall not
constitute a Commercial Sale.
1.6 "Confidential Information" shall mean any technical and
business information, including technical data, trade secrets, know-how or
other proprietary information provided to either Party by the other in
furtherance of this Agreement.
1.7 "Confidential Terms" shall mean those terms of this Agreement
related to the Ribozyme Price, and the amount of any royalties or other
payments payable hereunder, which constitute Confidential Information.
1.8 "Corporate Partner" shall mean any non-Affiliate entity or
independent corporation or company engaged in a contractual relationship with a
party for the purpose of converting Semi-finished Product into Product or
utilizing Semi-finished Product for Licensed Services, including marketing,
sales and distribution.
1.9 "Field" shall mean in vitro diagnostics for the diagnosis of
Target Disease using Ribozymes in Amplified Nucleic Acid Formats.
1.10 "Full Time Equivalent" shall mean efforts equivalent to a
scientist employed or hired by RPI to work full time on the research and
development of Semi-finish Products,
2
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
3
Products or Licensed Services, based on at least 225 full working days per year
of scientific work on or directly related to such Semi-finish Products,
Products or Licensed Services.
1.11 "FTE Rate" shall mean [ ] per annum for the period ending
one year from the Effective Date. Such FTE Rate shall be increased, but not
decreased, annually in subsequent years, if any, by an amount equal to the FTE
Rate for the preceding year multiplied by the Consumer Price Index, or some
other mutually agreeable index of inflation, or as otherwise agreed by the
parties.
1.12 "Gross Sales" shall mean the total sales proceeds received by
IntelliGene, and its Affiliates and Corporate Partners from the Commercial Sale
of Products or Licensed Services or the total sales proceeds received by RPI
and its Affiliates, Collaborators and Corporate Partners from the Commercial
Sale of products or services (and in the event of a reversion under Section
3.5.4, including Products and Licensed Services) which products or services are
developed, made, used or sold in whole or in part in reliance upon or otherwise
utilizing IntelliGene Technology available to RPI under Sections 2.3, 3.5.4,
5.2, or otherwise under this Agreement. Gross Sales shall not include sales of
Semi-finished Products to a Corporate Partner or an Affiliate.
1.13 "IntelliGene Technology" shall mean the issued patents and
patent applications listed on Exhibit A and foreign counterparts thereof as
well as all U.S. and foreign patents issuing therefrom, including any
continuations or continuations-in-part, divisions, reissues, renewals and
extensions thereof, and any additions thereto issued within ten years of the
date hereof, and trade secrets, know how, and trademark registrations owned or
licensed by IntelliGene.
1.14 "Licensed Services" shall mean any service within the Field,
other than the development, production and sale of a Product or Semi-finished
Product, which is performed for a third-party by IntelliGene, an Affiliate or a
sublicensee hereunder, and which includes use of a Semi-finished Product or
Product or any invention, method, process, procedure or technology which is
included, in whole or in part, in RPI Technology.
1.15 "Manufacturing Cost" shall mean the fully burdened cost,
expressed on a per unit manufactured basis, of manufacturing any given type of
Ribozyme (including rejected or returned units of such Ribozymes), together
with packaging thereof, including the cost of raw materials (with inventory
used for raw materials determined on an FIFO basis), direct labor and benefits,
costs of transition from clinical scale to commercial scale production, and
overhead (including depreciation, indirect costs and general and administrative
expense), all fairly allocable to such Ribozymes as determined in accordance
with generally accepted accounting principles and customary usage in the U.S.
pharmaceutical industry.
1.16 "Major Market" shall mean the [ ]
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Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
4
1.17 "New Ribozyme Technology" shall mean all proprietary
technology related to Ribozymes developed during the Term of this Agreement by
or for IntelliGene, its Affiliates and its Collaborators or licensed by
IntelliGene or its Affiliates and which IntelliGene or its Affiliates has the
right to sublicense to RPI during the Term of this Agreement.
1.18 "Net Sales" shall mean Gross Sales less (i) normal and
customary rebates, cash and trade discounts, (ii) credits for returns and
allowances, (iii) insurance costs borne by the seller, (iv) transportation
charges and (v) sales or other excise taxes or duties imposed upon and paid by
the seller with respect to such sales.
1.19 "Product" shall mean products designed, developed, and sold
against a Target Disease by IntelliGene (or RPI in the event of a reversion
under Section 4.5.4.), or an Affiliate, Collaborator or Corporate Partner and
which is generally in finished form and ready for end use without further
substantial chemical alteration.
1.20 "RPI Technology" shall mean the issued patents identified on
Exhibit B, and foreign counterparts thereof as well as all U.S. and foreign
patents issuing therefrom, including any continuations or
continuations-in-part, divisions, reissues, renewals and extensions thereof,
and any additions thereto issued within [ ] of the date hereof, and
registrations and licenses.
1.21 "Ribozyme" shall mean a nucleic acid molecule capable of
catalyzing reactions including, but not limited to, [ ]
1.22 "Ribozymes For Research" shall mean Ribozymes required by
IntelliGene for purposes of research and development of a Semi-finished
Product, Product or Licensed Service, including those required under a Work
Plan (as defined herein) approved by RPI.
1.23 "Ribozymes For Products" shall mean Ribozymes used in
Semi-finished Products, Products or Licensed Services.
1.24 "Ribozyme Price" shall mean [ ] of RPI's Manufacturing
Cost of Ribozymes meeting the Specifications set forth in the purchase order
for such Ribozymes submitted pursuant to Section 4.4 determined on a per unit
basis.
1.25 "Rolling Forecast" shall mean the forecast of IntelliGene's
projected purchase of Ribozymes prepared by IntelliGene pursuant to the terms
of Section 4.3.1.
1.26 "Semi-finished Product" shall mean ribozymes or products which
have not been substantially transformed by IntelliGene or an Affiliate into a
Product and which are transferred to a Corporate Partner in an arms length
transaction for the purpose of sales of Products and/or Licensed Services.
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Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
5
1.27 "Specifications" shall mean the appropriate specifications and
quality standards for each type of Ribozyme as the parties shall agree from
time to time. The parties initially agree that such Ribozymes shall have [ ]
purity.
1.28 "Target Disease" shall mean any one of the human diseases
listed on Exhibit C attached hereto, and any additional human diseases or
conditions for which a Work Plan has been approved by RPI in accordance with
Section 3.1.
1.29 "Term of this Agreement" shall mean the term provided for in
Section 7.1.
1.30 "Work Plan" shall mean a plan setting forth the proposed path
of development and marketing, including the anticipated market size and
countries targeted for commercialization, for Semi-finished Products, Products
or Licensed Services with respect to a particular Target Disease as provided
under Section 3.1.
ARTICLE 2
License
2.1 Grant to IntelliGene. Subject to the terms of this Agreement,
RPI hereby grants to IntelliGene a world-wide, exclusive license, with the
right to sublicense within the Field subject to Section 2.2, under the RPI
Technology to make ribozymes only for research purposes and to develop, use,
make and have made and sell Semi-finished Products, Products or perform
Licensed Services against Target Diseases provided, however, IntelliGene shall
have the right to sell Semi-finish Products only to Corporate Partners which
have entered into a sublicense with IntelliGene pursuant to Section 2.2.
IntelliGene's right to make or have made Semi-finished Products, Products and
perform Licensed Services shall be subject at all times to RPI's exclusive
right to manufacture and supply Ribozymes for those purposes under Article 4.
Nothing contained herein shall be construed as granting a license, implied or
otherwise, to IntelliGene or any third party to manufacture Ribozymes using the
RPI technology except under the conditions and as specifically set forth in
Section 4.10.
2.2 Sublicensing. Sublicensing of RPI Technology by IntelliGene,
to the extent permitted hereunder, shall be subject to (a) the express, written
consent of RPI, which consent shall not be unreasonably withheld; and (b) all
of the terms, conditions and limitations set forth in this Agreement, including
the following: (i) all such sublicensees of IntelliGene shall be obligated to
pay royalties, either directly or through IntelliGene, to RPI under terms no
more favorable to the sublicensee than those granted to IntelliGene hereunder;
and (ii) such sublicensees of IntelliGene shall be subject to the same
restrictions on the use, manufacture and sale of Ribozymes and/or RPI
Technology as contained herein with respect to the license
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Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
6
granted to IntelliGene hereunder. IntelliGene shall enter into a sublicense in
accordance with the terms of this Section 2.2 with each of its Corporate
Partners. Nothing in this Section or elsewhere in this Agreement shall be
construed to create an implied right of IntelliGene to sublicense any of the
RPI Technology outside the Field as identified herein or for any purpose other
than that permitted to IntelliGene hereunder.
2.3 Grantback to RPI. As partial consideration for the license
granted in this Agreement to IntelliGene by RPI, IntelliGene hereby grants to
RPI, for [ ], an exclusive, worldwide license with the right to sublicense,
subject to the royalties provided for in Section 2.5.4.1 and subject further to
IntelliGene's retained right to practice same, to New Ribozyme Technology and
to enhancements or improvements directly and essentially related to the claimed
subject matter of the patents which comprise the RPI Technology, whether or not
patented or patentable, developed and reduced to practice by IntelliGene, its
Affiliates and its Collaborators during the Term of this Agreement.
2.4 Reservation of All Other Rights. Nothing contained herein
shall be construed as granting a license, implied or otherwise, to IntelliGene
or any third party to manufacture Ribozymes using the RPI Technology except
under the conditions and as specifically set forth in Section 2.1 and Section
4.10. Except as expressly set forth in this Agreement, nothing contained
herein shall be construed as to create any right of IntelliGene in the RPI
Technology or RPI in IntelliGene Technology or in New Ribozyme Technology or in
the other's other intellectual property including, but not limited to, any U.S.
or foreign patents or patent applications (including any reissues, extensions,
substitutions, confirmations, registrations, revalidations, additions,
continuations, continuations-in-part and divisions thereof) relating to the
design, synthesis, delivery, development, testing, use and sale of Ribozymes or
diagnostic technology.
2.5 Royalties and Fees.
2.5.1 License Fees. Within 30 days of the date hereof, RPI
will be paid a License Fee in the amount of [ ]
2.5.2 Research and Development Payments.
2.5.2.1 For each of the three fiscal years
beginning March 1, 1997, 1998 and 1999 and IntelliGene shall pay RPI [ ]
per year, payable in quarterly installments in advance, for research support as
agreed by the parties to advance commercialization of Product and Licensed
Services and for access to RPI's scientists, including consultants.
2.5.2.2 For each of the three fiscal years
beginning March 1, 1997, 1998 and 1999, RPI agrees to pay [ ]. RPI shall
have the right for non-diagnostic purposes to use
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Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
7
all such technology obtained or licensed by IntelliGene resulting from such
research and development funding.
2.5.2.3 Within two months of the end of the first
calendar quarter in which IntelliGene, its Affiliates, its Collaborators and
its Corporate Partners receive for a Product or Licensed Service cumulative Net
Sales in excess of [ ] IntelliGene will pay RPI [ ] in support of RPI's
research on Ribozymes the results of which will be reported to IntelliGene.
Such amount will be payable for each Product or Licensed Service achieving in
excess of [ ] in Net Sales.
2.5.3 Royalties Payable to RPI.
2.5.3.1 During the Term of this Agreement, RPI
will be paid a royalty on cumulative Net Sales for each separate Product or
Licensed Service as follows:
[ ] on Net Sales of [ ];
[ ] on Net Sales over [ ]; and
[ ] on Net Sales [ ]
2.5.3.2 In no event shall RPI be due multiple
royalties for sales of the same Product or Licensed Services.
2.5.3.3 Anything herein to the contrary
notwithstanding, [ ] of the royalty otherwise payable shall be paid by
IntelliGene on Net Sales of Products or Licensed Services which would not
infringe on RPI's patent rights even if RPI had not granted the licenses
contained herein because RPI has no patent rights in the jurisdiction in which
Products were sold or the License Services were performed or because RPI's
relevant patent rights had expired, lapsed or were declared invalid or
unenforceable by a court of competent jurisdiction.
2.5.3.4 Anything herein to the contrary
notwithstanding, in the event IntelliGene's rights to a Target Disease are
based on a non-exclusive license from RPI, the royalty payable shall be [ ]
of what such royalty would otherwise be.
2.5.4 Royalties Payable to IntelliGene.
2.5.4.1 IntelliGene will be paid a royalty for any
exploitation by RPI or any of its sublicensees of the rights granted under
Section 2.3 of this Agreement. Such royalty shall be [ ] on Net Sales of
each product or service [ ], [ ] of Net Sales of each product or service
[ ] but [ ]; and [ ] of Net Sales of each product or service of [ ]
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Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
8
2.5.4.2 IntelliGene will be paid a royalty for any
exploitation by RPI or any of its sublicensees of the rights granted under
Section 3.5.4. For each such Semi-finished Product, Product or Licensed
Product, such royalty shall be[ ] on Net Sales of [ ], [ ] of Net Sales
[ ] but [ ]; and [ ] of Net Sales of [ ], and, provided further, that
the royalties paid on Products, Semi-finished Products, and Licensed Services [
].
2.5.4.3 In no event shall IntelliGene be due
multiple royalties for sales of the same product or service.
2.5.5 Payment and Reporting. All royalties to be paid
under this Agreement shall be paid quarterly within two (2) months after the
close of each quarter, i.e., on or before the last day of each of the months of
February, May, August and November immediately following each quarterly period
immediately preceding such months for which royalties are due. On each such
quarterly payment date, each party shall furnish the other party with a royalty
statement, setting forth the Net Sales by such party of each product and
service and the total number of units of each product and service sold for the
quarter for which the royalties are due. A party's obligation to pay royalties
shall arise when proceeds are received. Upon termination of this Agreement,
each party shall promptly (i.e., within ninety (90) days) report and pay to the
other the applicable royalty for sales made prior to the termination.
2.5.6 Records/Audit Rights. Each party shall keep accurate
books and accounts of record in connection with sales by or for it of Products
and Licensed Services (and products and services, if relevant) in sufficient
detail to permit accurate determination of all figures necessary for
verification of royalty obligations set forth in the previous paragraph. Each
party shall maintain such records for a period of three (3) years from the end
of each annual sales period. Each party, at its expense, through a certified
public accountant, shall have the right to access such books and records for
the sole purpose of verifying such statements; such access shall be conducted
after reasonable prior notice by such party to the other during ordinary
business hours and shall not be more frequent than once during each calendar
year. The party initiating such verification shall pay the cost of such
verification provided that, if as a result of such verification it is
determined that the verified amount due that party exceeds the amount actually
paid in the period by the lesser of [ ] of such verified amount, the cost of
such verification shall be paid by the other party. Said accountant shall not
disclose any information except that which should be properly contained in a
royalty report required under this Agreement. Each party further agrees to
execute any confidentiality agreement reasonably required by the other to
protect the proprietary nature of any such royalty report and the information
contained therein.
2.5.7 Currency and Taxes. All payments to be made by the
paying party hereunder shall be made in U.S. dollars in the United States to a
bank account designated by the payee party. Royalties earned in U.S. dollars
shall be paid in U.S. dollars. Royalties earned in other currencies shall be
first determined in the currency of the country in which they are earned
8
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
9
and converted by the paying party into U.S. dollars at the buying rates of
exchange for the currencies involved as published in the Wall Street Journal
(or its successor in interest) at the close of business on the last business
day of the quarterly period in which the royalties were earned. Any income or
other tax that a party or its sublicensee is required to withhold and pay on
behalf of the other with respect to the royalties payable under this Agreement
shall be deducted from said royalties prior to remittance; provided, however,
that in regard to any tax so deducted, the paying party shall give or cause to
be given to the other party such assistance as may reasonably be necessary to
enable such party to claim exemption therefrom or credit therefor, and in each
case shall furnish to such party proper evidence of the taxes paid on its
behalf.
ARTICLE 3
Product Development
3.1 Target Diseases. In addition to the initial Target Diseases
listed on Exhibit C attached hereto and incorporated by this reference herein,
IntelliGene may identify other specific diseases which it proposes to have RPI
designated as a "Target Disease" and, upon IntelliGene's written request, RPI
shall promptly inform IntelliGene [ ] Nothing contained herein shall be
construed to require RPI to make available for designation as a Target Disease
any disease to the extent that RPI has already granted a license, or an
unrestricted right to obtain a license, to the RPI Technology that would
exclude IntelliGene from using the RPI Technology in the development, use or
sale of a Semi- finished Product, Product or Licensed Service in connection
with such disease. IntelliGene acknowledges that diagnostic applications for
certain diseases are included in the licenses granted previously to Chiron
Corporation and the Xxxxx Xxxxx Division of Xxxxxx Xxxxxxx Company [ ]
Upon notification to IntelliGene by RPI that the disease identified as a
potential Targeted Disease is available to the designated as an additional
Target Disease, IntelliGene shall have a binding option for ninety (90) days
to notify RPI in writing requesting designation of the disease as an additional
Target Disease. Said notice shall be accompanied by a proposed Work Plan, to
be received as Confidential Information, covering all Major Markets and shall
be supported by any laboratory or clinical data with respect to such disease
that IntelliGene may have produced. RPI shall have the right to approve the
Work Plan, including the marketing plan which is a part thereof, which approval
shall not be unreasonably withheld, and shall be given or withheld within a
reasonable time after RPI has received such Work Plan and supporting data.
Approval of any Work Plan with respect to any additional Target Disease by RPI
shall constitute a grant of an exclusive license under the RPI Technology to
IntelliGene for Semi- finished Products, Products and Licensed Services against
such Target Disease in the Field, unless based on its then existing contractual
agreements RPI is only able to grant IntelliGene a non-exclusive license, in
which case the licenses granted to IntelliGene shall be on a non-exclusive
basis. Upon each approval of a Work Plan by RPI for a Target Disease not
listed in Exhibit C, IntelliGene shall pay RPI [ ] in support of research by
RPI for such new Target Disease.
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Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
10
3.2 Development. IntelliGene will have sole responsibility to
complete the development of Semi-finished Products, Products and Licensed
Services with respect to each Target Disease on a commercially reasonable best
efforts worldwide basis for the specific Targeted Disease, subject to
IntelliGene's obligations of due diligence set forth in Section 3.5, and,
except as may expressly be provided, to pay all costs and expenses associated
with such development, marketing and sales. RPI shall have the right to
develop Semi-finished Products, Products and Licensed Services with respect to
a Target Disease in any country not covered by the Work Plan for such Target
Disease provided, however, if the Work Plan covers all Major Markets and
IntelliGene proceeds with due diligence in all Major Markets generally in
accordance with the Work Plan, IntelliGene shall preserve the right to all
countries worldwide. IntelliGene shall commercialize as the first Product or
Licensed Service one Target Disease identified on Exhibit C and thereafter
commercialize [ ] the additional Target Diseases identified on Exhibit C.
Provided however, IntelliGene shall have the right to abandon its right to
develop any Target Disease on Exhibit C under Section 3.5.3 and substitute such
Target Disease with a new Target Disease designated under Section 3.1, without
the payment of [ ].
3.3 RPI Research Support. In the event that IntelliGene requires,
in addition to the research support provided for in Section 2.5.2, research
support from RPI for the development of Semi-finished Products, Products and
Licensed Services, RPI will provide such Full Time Equivalents as the parties
shall mutually agree at the FTE Rate plus materials costs and expenses.
3.4 Regulatory Approval. IntelliGene will be responsible for and
control contacts with worldwide regulatory agencies and will own all
applications to, and all permits or exemptions issued by, the U.S. Food and
Drug Administration and their foreign equivalents with respect to any
Semi-finished Products, Products and Licensed Services, except in those
countries where the rights to such Semi-finished Products, Products and
Licensed Services have reverted to RPI under Sections 3.5.2 and 3.5.3. All
such activities shall be conducted at IntelliGene's sole expense. For joint
filings, IntelliGene and RPI will coordinate contacts with regulatory agencies
with IntelliGene acting as primary contact. Unless otherwise agreed by RPI,
IntelliGene will develop and register Semi-finished Products, Products and
Licensed Services first in the United States, the European Economic Community
or Israel. RPI shall, at RPI's expense, and to the extent necessary, provide
such information to the FDA and to other regulatory authorities, maintain such
files internally and with FDA and such other regulatory authorities, maintain
all licenses and other approvals, allow regulatory inspections, and otherwise
cooperate with the FDA, with other regulatory bodies, and with IntelliGene, as
may be required in order to register, license or otherwise gain marketing
approval or clearance in any county identified in a Work Plan approved by RPI.
10
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
11
3.5 Diligence/Abandonment.
3.5.1 Due Diligence. IntelliGene shall be obligated to use
due diligence in the development, marketing and sale of Semi-finished Products,
Products and Licensed Services, using best efforts consistent with new product
introduction, marketing of existing products and prudent business judgment. If
IntelliGene concludes that the development or marketing and sales of
Semi-finished Products, Products and Licensed Service against a Target Disease
in a country or countries will not be reasonably profitable to IntelliGene, it
shall not be obligated to proceed with due diligence in such country or
countries. In such event, IntelliGene shall be obligated to promptly inform
RPI of such conclusion and that it is abandoning its rights to all
Semi-finished Products, Products and Licensed Services against such Target
Disease in such country or countries pursuant to Section 3.5.3. If IntelliGene
is proceeding with due diligence in the European Economic Community as a whole
it shall be presumed for purposes of this Agreement to be proceeding with due
diligence in each member country of the European Economic Community. If
IntelliGene is proceeding in accordance with the Work Plan for a Target
Disease, it shall be conclusively presumed to be proceeding with due diligence
with respect to such Target Disease.
3.5.2 Requirement to Commercialize. Unless IntelliGene
shall have achieved commercial sales of a Product or Licensed Service against
at least one Target Disease in a Major Market prior to July 1, 2000 (the
"Expiration Date"), the licenses granted to IntelliGene shall terminate and all
rights to Semi-finished Products, Products and Licensed Services against the
Target Diseases shall revert to RPI provided, however, the Expiration Date may
be extended by the payment by IntelliGene to RPI of the following minimum
royalties. The Expiration Date may be extended to January 1, 2001, by the
payment by IntelliGene to RPI of minimum royalties in the amount of [ ] on or
prior to July 1, 2000. The Expiration Date may be further extended to July 1,
2001, by the payment by IntelliGene to RPI of minimum royalties in the amount
of [ ] on or prior to January 1, 2001. The Expiration Date may be further
extended to January 1, 2002, by the payment by IntelliGene to RPI of minimum
royalties in the amount of [ ] on or prior to July 1, 2002. The Expiration
Date may not be extended beyond January 1, 2002.
3.5.3 Lack of Diligence/Abandonment. If IntelliGene fails
to develop, market or sell any Semi- finished Products or Products against a
Target Disease diligently in any Major Market and fails to develop, market or
sell Licensed Services against such Target Disease in such Major Market as
required by Section 3.5.1.1, all rights to Semi-finished Products, Products and
Licensed Services against such Target Disease in such Major Market and any
other country in which IntelliGene is not proceeding with due diligence shall
automatically revert to RPI 180 days after notice by RPI if IntelliGene has not
corrected such lack of diligence. If at any time IntelliGene concludes that it
will not pursue, either directly or through a sublicense, the development,
marketing or sale of either a Semi-finished Product, Product or a Licensed
Service against a Target Disease in any country for which it has rights,
IntelliGene will timely notify RPI that it intends to abandon its rights in
that country, and all such rights to Semi-finished Products, Products and
Licensed Services against such Target Diseases in such country shall
automatically revert to RPI.
11
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
12
3.5.4 Reversion of Rights. Upon the reversion of rights to
any Semi-finished Product, Product or Licensed Service or to all Products or
Licensed Services in any or all countries to RPI under Sections 3.5.2 and
3.5.3, RPI, at its election, will have the right, upon timely notice to
IntelliGene, thereafter to use all relevant data, including research,
preclinical, clinical and regulatory data, of IntelliGene in the pursuit of its
rights in such country or countries regardless of where the data was generated,
provided, however, that use of such data shall be limited to use for the
Semi-finished Product, Product or Licensed Service for which RPI has reversion
rights. Subject to the provisions of section 2.5.4.2 of this Agreement, RPI
shall have an exclusive license, with full rights to sublicense, to develop,
use, manufacture, and sell any such Semi-finished Product, Product or Licensed
Service in any such country or countries. Such license shall include the
exclusive rights to all IntelliGene's then existing patents, trademarks,
know-how, trade secrets, and other technology and intellectual property,
including New Ribozyme Technology, as to such Semi-finished Product, Product or
Licensed Service, but, except as otherwise provided herein, IntelliGene shall
retain all other rights to such technology and property for all other uses, and
for all other countries. RPI shall also be subject to the payment to
IntelliGene of all royalties that IntelliGene may be required to pay to any
third parties under such IntelliGene Technology and intellectual property as to
such Semi-finished Product, Product or Licensed Services.
3.5.5 Reporting and Rights of Inspection. IntelliGene
shall furnish RPI with reports no less frequently than quarterly regarding the
actions taken and progress achieved, including laboratory and clinical data not
previously supplied to RPI by IntelliGene, with respect to the development and
commercialization of each Semi-finished Product, Product or Licensed Service in
each country targeted, which shall be received as Confidential Information. In
addition, upon RPI's request and no more than once every six months,
IntelliGene shall give to RPI a full oral progress report, which shall be
received as Confidential Information. In conjunction with each said oral
progress reports, RPI shall have the right, upon reasonable prior notice and
during normal business hours, to reasonably review IntelliGene's records with
respect to the development and commercialization of Semi-finished Products,
Products or Licensed Services, including the right to audit IntelliGene's
financial records to verify that IntelliGene is using due diligence.
ARTICLE 4
Manufacture and Supply of Ribozymes
4.1 RPI's Rights to Manufacture. RPI shall have the right to
manufacture all Ribozymes For Products. The manufacture of chemically
synthesized Ribozymes shall be on the terms set forth below. The manufacture
of other Ribozymes shall be on terms mutually agreed to by the parties.
12
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
13
4.2 Purchase and Sale of Ribozymes. Subject to the terms,
conditions and limitations hereof, during the Term of this Agreement RPI agrees
to supply to IntelliGene using commercially reasonable efforts, and IntelliGene
agrees to purchase from RPI all of IntelliGene's requirements for Ribozymes For
Products under this Agreement. RPI shall have the right to contract with third
parties for the manufacture and supply of any or all Ribozymes or any component
thereof to be supplied hereunder as long as RPI remains subject to and
obligated under the terms of this Agreement. All Ribozymes shall be ordered
and supplied hereunder according to the Specifications for such Ribozymes.
4.3 Amount of Ribozymes For Products.
4.3.1 Rolling Forecast. In connection with the supply of
Ribozymes For Products by RPI hereunder, IntelliGene shall notify RPI prior to
each calendar quarter in writing of its projected purchases of Ribozymes For
Products for each calendar quarter of the following twelve (12) month period
(the "Rolling Forecast"). The Rolling Forecast shall include for each Product
the amount of Ribozymes For Products projected to be purchased by IntelliGene
in each quarter.
4.3.2 Purchase Amounts. IntelliGene agrees to purchase in
each quarter no less than [ ] of the amount of Ribozymes For Products
forecast for such quarter in the last Rolling Forecast provided RPI before the
purchase order is submitted by IntelliGene for such quarter.
4.3.3 Supply Amounts. RPI shall not be obligated to supply
during any quarter more than [ ] of the amount of Ribozymes For Products
forecast for such quarter in the last Rolling Forecast provided RPI before the
purchase order is submitted by IntelliGene for such quarter.
4.4 Purchase Orders. IntelliGene shall place firm purchase orders
with RPI for all Ribozymes, at least ninety (90) days prior to the specified
time for shipment. All orders placed by IntelliGene hereunder shall be in
writing in the form of a purchase order, shall be identified by a purchase
order number, shall include the Specifications for the Ribozymes being
purchased and shall be transmitted to RPI by mail or facsimile. Each purchase
order shall identify the type, quantity, unit price, total purchase order
price, shipping instructions, delivery dates and any other special information
with respect to the Ribozymes purchased. When ordering, IntelliGene may employ
its standard forms, but nothing in such forms shall be construed to modify or
amend the terms of this Agreement, and if there is a conflict between the
provisions of this Agreement and such forms, the provisions of this Agreement
shall control. IntelliGene may place an order by telephone provided that a
written purchase order is submitted within five (5) days of such order.
4.5 Ribozyme Price. IntelliGene shall pay the Ribozyme Price for
all Ribozymes furnished by RPI provided that if the purity and other
characteristics of such Ribozymes exceed
13
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
14
the minimum required by the Specifications, such Ribozyme Price shall not be
more than the Ribozyme Price would have been for Ribozymes meeting the minimum
requirements of the Specifications including the requirements as to purity.
The Ribozyme Price for each ribozyme supplied shall be separately determined
semi-annually. Unless otherwise agreed in writing by the Parties, the Ribozyme
Price shall be F.O.B. RPI's manufacturing facility.
4.6 Records/Audit Rights. RPI shall keep detailed records in
connection with the manufacture of Ribozymes for Products to permit accurate
determination of all figures necessary for verification of the Ribozyme Price.
RPI shall maintain such records for a period of three (3) years from the end of
each annual sales period. IntelliGene, through a certified public accountant,
shall have the right to access such records for the sole purpose of verifying
such Ribozyme Price; such access shall be conducted after reasonable prior
notice by IntelliGene to RPI during ordinary business hours and shall not be
more frequent than twice during each calendar year. IntelliGene shall pay the
cost of such verification provided that, if as a result of such verification it
is determined that the Ribozyme Price charged to IntelliGene by RPI exceeds
that amount actually charged to IntelliGene in the period by 5% of such
verified amount, the cost of such verification shall be paid by RPI. Said
accountant shall not disclose any information except that which should be
properly contained in a report verification the Ribozyme Price for the period
in question. IntelliGene further agrees to execute any confidentiality
agreement reasonably required by RPI to protect the proprietary nature of any
such manufacturing report and the information contained therein.
4.7 Shipment. RPI will use commercially reasonable efforts to
ship all Ribozymes in the form and at the time specified by IntelliGene in a
purchase order, with the proper identification on the packaging as required by
applicable authorities. As to each order placed by IntelliGene, RPI shall ship
Ribozymes to such destination and by such carrier identified by IntelliGene.
All shipments shall be F.O.B. RPI's manufacturing facility, and title and risk
of loss as to all goods shipped shall pass upon transfer by RPI to such carrier
at RPI's manufacturing facility. IntelliGene or its designee shall be the
importer of record of each shipment.
4.8 Payment. Within ten days after each shipment ordered and
shipped pursuant to this Agreement, an invoice relating to such shipment shall
be rendered by RPI to IntelliGene, and payment thereon shall be due within
thirty (30) days of the receipt of the invoice. IntelliGene shall pay RPI
interest on overdue payments at the lessor of: (i) 18% per annum or (ii) the
maximum rate allowed under applicable law. All payments shall be made in U.S.
dollars.
4.9 Non-Conforming Goods. IntelliGene shall inspect all Ribozymes
delivered by RPI under this Agreement within thirty (30) days after receipt
thereof, and may reject any goods that are not in conformance with the
applicable Specifications, provided that such Ribozymes have not been used,
abused or damaged by IntelliGene or its agents. To reject any ribozyme
14
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
15
delivery, IntelliGene shall notify RPI in writing of the rejection and at RPI's
expense promptly return the rejected goods to RPI. Any notice of rejection
must be submitted to RPI within thirty (30) days of receipt of the
non-conforming goods by IntelliGene accompanied by a written statement as to
how such Ribozymes do not conform to type or fail to meet such Specifications.
Any Ribozymes not properly and timely rejected by IntelliGene shall be deemed
accepted. RPI's liability for non-conforming goods shall be limited to its
obligation to repair or replace such non-conforming goods at its own expense
and within a reasonable time after RPI has confirmed, in its reasonable
judgment, that such goods are non-conforming, but not later than thirty (30)
days after it has received the returned goods, and in no event shall RPI be
liable for damages of any type or nature resulting therefrom including any
consequential or incidental damages.
4.10 Alternative Suppliers. In the event that RPI is unable to
supply Ribozymes For Products within 120 days after receipt of a purchase order
from IntelliGene (i.e., RPI is at least thirty (30) days late in making
delivery to IntelliGene), IntelliGene's sole remedy shall be to obtain
alternative supplies of Ribozymes For Products as provided herein. In such
event, IntelliGene or another third party jointly acceptable to RPI and
IntelliGene, which acceptance will not be unreasonably withheld, will be
granted a temporary, royalty-free (to RPI) non-exclusive license (the "Supplier
License") under the RPI Technology to make or have made Ribozymes For Products
in the amounts set out in Section 4.3.3 solely for the purposes set forth in
this Agreement and for the period until 90 days after RPI provides written
notice to IntelliGene that it can again provide Ribozymes For Products. At
that point, RPI shall again be the exclusive supplier and the Supplier License
will terminate. As soon as RPI is aware that it is unable to timely supply
Ribozymes For Products, RPI shall immediately provide IntelliGene or its third
party designee all information, know-how, procedures and other information
necessary or desirable to efficiently, reliably and effectively function as a
supplier of the Ribozymes For Products without any interruption in
IntelliGene's supply. All information, know-how, procedures and other
information supplied by RPI to IntelliGene or its designee and for use in the
manufacture of Ribozymes shall be immediately returned to RPI at the conclusion
of the Supplier License without retaining copies. Any Supplier License shall
be subject to the payment to RPI by such alternative supplier of all royalties
that RPI may be required to pay to any third parties under the RPI Technology
with respect to the Ribozymes manufactured or supplied by such alternative
supplier under the Supplier License. RPI's failure or refusal to supply more
that the amounts specified in Section 4.3.3 shall not be any inability to
supply within the meaning of this Section.
4.11 Permitted Uses. IntelliGene shall use Ribozymes supplied
hereunder solely for the purposes set forth in this Agreement.
4.12 Compliance With Law. IntelliGene shall be responsible, at its
expense, for complying with all applicable regulatory requirements relating to
its export, use, marketing or sale of Semi-finished Products, Products,
Licensed Services, or Ribozymes supplied hereunder.
15
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
16
RPI shall be responsible, at its expense, for complying with all applicable
regulatory requirements for its manufacture of Ribozymes hereunder and RPI
hereby warrants that it will manufacture all Ribozymes supplied hereunder in
accordance with the applicable requirements of the Federal Food, Drug, and
Cosmetic Act of 1938, as amended, and the applicable rules and regulations
thereunder. IntelliGene shall have the right, upon reasonable notice and at
reasonable times, to visit RPI's manufacturing facilities with a representative
of RPI present in order to assure compliance with the requirements of this
Section.
4.13 Limitation of Liability; Warranties. RPI warrants that the
Ribozymes supplied hereunder shall be in accordance with the Specifications.
RPI's liability for non-conforming Ribozymes supplied hereunder shall be
limited to its obligation to replace them and in no event shall RPI be liable
for damages of any type or nature whatsoever resulting therefrom including any
consequential or incidental damages. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED
HEREIN, RPI MAKES NO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE GOODS
SUPPLIED HEREUNDER INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR WARRANTIES THAT GOODS WILL BE FREE OF CLAIMS OF
INFRINGEMENT BY THIRD PARTIES.
4.14 Product Handling and Distribution. IntelliGene shall identify
Semi-finished Products and Products sold, used in a Licensed Service or
otherwise distributed by it with a vendor lot number that is traceable to the
specific shipment of Ribozymes purchased from RPI hereunder. Twice a calendar
year, upon reasonable notice and at reasonable times, IntelliGene shall permit
RPI to visit IntelliGene's facilities with a representative of IntelliGene
present in order to review IntelliGene's product handling and distribution
procedures and records to assure compliance with the requirements of this
Section. To the extent RPI exercises its right of inspection under section
3.5.5, RPI's inspection hereunder shall take place at the same time.
4.15 Condition Subsequent. Anything herein to the contrary
notwithstanding, the Grant as set forth in paragraph 2.1 shall only be
contingent on IntelliGene's purchase of its Ribozymes from RPI when, where and
for so long as the patents included in the RPI Technology cover the
manufacture, use and sale of the Ribozymes used in the Semi- finished Products,
Products or Licensed Services. It is further understood and agreed that in the
event a source(s) of an alternative to the Ribozymes to be provided by RPI
should become available, which alternative is not covered by the claims of the
patents included in the RPI Technology (i.e., a non-infringing alternative),
IntelliGene shall have the right and option to fulfill its requirements from
such source(s) without affecting any of its rights under this Agreement,
provided RPI shall have the right of first refusal to furnish such Ribozymes on
the terms offered by such alternative source.
16
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
17
ARTICLE 5
Intellectual Property.
5.1 Intellectual Property. All rights in inventions, discoveries,
biological samples and other research materials created during the course of
the Agreement shall be the property of the creating party. Inventorship will
be determined according to U.S. patent law. IntelliGene and RPI shall promptly
disclose to each other in writing each invention and discovery conceived and/or
reduced to practice related to this Agreement. Inventions or discoveries
whether or not patentable which are made solely by an employee or agent of RPI
shall be owned by RPI. Inventions or discoveries whether or not patentable
which are made jointly by an employee or agent of RPI and IntelliGene shall be
jointly owned by RPI and IntelliGene. Inventions or discoveries whether or not
patentable which are made solely by an employee or agent of IntelliGene shall
be owned by IntelliGene. The parties agree to cooperate in the preparation and
execution of documents necessary to effect such patent filings. RPI shall have
the right to control the prosecution of patents for jointly-owned inventions
and, provided both parties agree that patent protection should be sought, each
party shall pay one-half of the reasonable and necessary cost of such patent
prosecution.
5.2 Patents. At its sole discretion, IntelliGene may file and
prosecute at its own expense and cost and using counsel of its choosing any
additional patent applications on inventions owned by it and believed necessary
or desirable for the development and commercialization of Semi-finished
Products, Products or Licensed Services. Subject to the confidentiality
obligations of Article 6, RPI shall have the right to review and comment on all
patent filings (including applications and responses to patent office actions),
but only to the extent such patent filings constitute enhancements or
improvements directly and essentially related to the claimed subject matter in
RPI Technology, which were conceived and/or reduced to practice by IntelliGene
under this Agreement, prior to their being filed by IntelliGene, but provided
that such review and/or comment will not delay submission of materials to the
relevant patent office. In addition, in the event that RPI or any of its
Collaborators are developing therapeutics using Ribozymes against particular
Target Diseases, IntelliGene will grant to RPI for use once a therapeutic
indication for such Targeted Disease is approved for marketing in any Major
Market a non-exclusive field of use license, with the right to sublicense to
such Collaborator, to any such IntelliGene patent issued in connection with any
Semi-finished Product, Product or Licensed Service, limited to use in
applications, other than diagnostics, against the particular Target Diseases in
countries where approval to market such therapeutic indication has been
obtained, or is not needed, on such terms as the parties shall agree.
5.3 Enforcement of Rights.
5.3.1 Markings. On or in connection with each
Semi-finished Product, Product or Licensed Service sold by IntelliGene,
IntelliGene shall legibly xxxx or provide an appropriate notice of RPI's patent
rights in a reasonable form and substance approved in
17
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
18
advance by RPI in writing. Upon request by RPI, IntelliGene shall provide
proof, including specimens, demonstrating that the obligations of this
paragraph have been complied with.
5.3.2 Enforcement Against Third Parties. IntelliGene
agrees to promptly notify RPI of known conduct by any third party which may
constitute in the Field a direct or contributory infringement or the inducement
of infringement of RPI's patent or other rights in or to the RPI Technology or
otherwise constituting a violation of any of the RPI Technology. RPI shall
have 180 days after it becomes aware of such infringement within which to cause
such third party to cease its infringement or bring legal action aimed at
causing the third party to cease such infringement. If such infringement is
not terminated within such 180-day period or a legal action is not initiated by
the party having such rights, then IntelliGene shall have the right but not the
obligation to initiate legal action to protect its rights under the licenses
granted by RPI under this Agreement. Each party shall have the right to join or
intervene in any action initiated by the other. If the non-initiating party
does not join or intervene in any action brought, the initiating party shall
pay all costs of bringing and prosecuting the action and shall be entitled to
keep all damages and other amounts recovered. In such case, the non-initiating
party agrees to cooperate with the initiating party to the extent necessary
provided the initiating party pays the non-initiating party's reasonable
expenses and costs. If the non-initiating party joins or intervenes in the
legal action, all damages and other amounts recovered shall be first used to
pay each party's costs and expenses of bringing and prosecuting the legal
action and the remainder shall be split evenly by the parties. If, in such
case, the amount recovered is not sufficient to reimburse each party for its
costs and expenses of bringing and prosecuting such legal action, the parties
will split such amount pro rata based upon each party's total costs and
expenses.
5.3.3 Right to Defend. RPI shall have the sole right and
discretion to defend against any claims that the practice of the RPI Technology
infringes the patent or intellectual property rights of any third party,
provided that IntelliGene shall cooperate with RPI in any such defense. In
addition to the foregoing, RPI shall be responsible, in its sole discretion and
at its own expense, for filing, prosecuting, maintaining and renewing its
rights to the RPI Technology.
5.4 Trademarks. All trademarks resulting from the
commercialization of Semi-finished Products, Products or Licensed Services will
be filed, maintained and owned on a worldwide basis by IntelliGene. If
IntelliGene abandons its right to sell any Semi-finished Product, Product or
Licensed Service in any country, RPI shall have the right and license to use
these marks in that country. IntelliGene shall cause RPI's trademark to be
placed on Semi-finished Product, Product or Licensed Service in all countries
except those where it is not permitted to do so by law or regulation and RPI
grants IntelliGene a license to use its trademark for such purposes.
18
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
19
ARTICLE 6
Confidential Information
6.1 Confidentiality. Each party represents that it maintains
policies and procedures designed to prevent unauthorized disclosure of its own
proprietary data and information. All employees, consultants, Collaborators,
Corporate Partners, Alternative Suppliers and other agents of a party to whom
any of the Confidential Information of the other party is disclosed shall have
either (a) executed written agreements in the normal course of their employment
having the effect of prohibiting the disclosure of Confidential Information
except on the terms permitted in this Agreement, or (b) be required to execute
a written agreement specifically prohibiting the disclosure of Confidential
Information, except on the terms permitted in this Agreement.
6.2 Non-disclosure. Except as expressly provided in this
Agreement or as otherwise agreed in writing: (a) IntelliGene agrees not to
disclose any Confidential Information of RPI except to: (i) its employees,
consultants and/or agents who require access to the Confidential Information in
order to further the derivation, development, production, or marketing of any
Semi-finished Product, Product or Licensed Service; or (ii) to permitted
sublicensees under this Agreement, subject to the restrictions and limitations
hereof; (b) RPI agrees not to disclose any Confidential Information of
IntelliGene except to (i) its employees, consultants and/or agents who
require access to the Confidential Information in order to carry out the terms
of this Agreement; or (ii) to permitted sublicensees under this Agreement,
subject to the restrictions and limitations hereof; and (c) each party agrees
not to disclose any Confidential Information of the other party except: (i)
that which is required to be disclosed by any applicable law or by a rule or
regulation by any governmental agency having jurisdiction over a party or (ii)
to third parties for purposes of obtaining financing or in connection with the
evaluation or completion of a business merger or acquisition if such
Confidential Information is material in the opinion of such parties' counsel
and its disclosure is reasonably required for the purposes of the intended
transaction; provided, that prior to any such disclosure, such third parties
shall be subject to a written agreement (or, if written agreements are not
customary in any circumstance, otherwise legally subject to obligations)
prohibiting use and disclosure of Confidential Information as provided herein,
and, in each case, such disclosure shall be limited only to the extent that
such disclosure is reasonably necessary under the circumstances.
6.3 Non-use. Each party agrees that it will use all Confidential
Information received from the other solely for the purposes authorized under
this Agreement.
6.4 Sub-Licensing Agreements. Each party hereto represents that,
in connection with the permitted sublicense of RPI Technology and IntelliGene
Technology under this Agreement, each shall cause all such sublicensees to be
subject to a sub-license agreement
19
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
20
containing non-disclosure and non-use provisions providing substantially the
protection of Confidential Information as contained herein.
6.5 Publications and Other Disclosures. Each party hereto agrees
not to publish the results of research and development work performed with the
other's technology, the right to which was obtained under this Agreement,
without the express written consent of the other which consent shall not be
unreasonably withheld. In the event that either party proposes to make such
public disclosure, it shall send a copy of the information to be disclosed to
the other, and shall allow the producing party sixty (60) (or, in the case of
proposed oral disclosures, thirty (30) days from the date of mailing in which
to object to such disclosure. If no objection is received prior to the
expiration of such sixty (60) or thirty (30) day period, the producing party
shall be free to proceed with the disclosure. If, due to a valid business
reason (including the assertion that such publication discloses Confidential
Information or should be withheld to protect a party's commercial interest
therein) or a reasonable belief by the receiving party that the disclosure
contains subject matter for which a patent should be sought, then prior to the
expiration of such sixty (60) or thirty (30) day period, the receiving party
shall so notify the producing party of the objection, who shall then refrain
from public disclosure of the information unless and until the parties have
agreed through good faith negotiation on the appropriate protections or changes
to the subject matter to be disclosed or other action to be taken. The
determination of authorship for any paper shall be in accordance with accepted
scientific practice.
6.6 Exemption. The non-disclosure and non-use provisions of this
Agreement shall not apply to any Confidential Information which:
(a) was already known to a party through means not involving an
obligation of confidentiality at the time it received such information under
this Agreement, and which prior knowledge is reflected in written records of
such party;
(b) is or becomes generally available to the public or otherwise part
of the public domain through means not involving the breach of any obligation
owed to either party under this Agreement or otherwise;
(c) is subsequently disclosed to a party by a third party through
means not involving the breach of any obligation owed to the other party under
this Agreement or otherwise;
(d) is required to be disclosed by regulation, law or court order; or
(e) is information that is independently developed by a party without
the use of any Confidential Information of the other and which independent
development can be demonstrated by contemporaneous documentation.
20
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
21
6.7 Confidential Terms. No public disclosure of the Confidential
Terms of this Agreement (including press releases, advertising, governmental
filings, discussions with lenders, investment bankers, public officials and the
media and other statements made available generally by a party hereto to the
public) will be permitted without prior review by and express consent of each
party prior to such disclosure, and neither party hereto shall disclose such
Confidential Terms to any third party without the prior consent of the other,
which consent shall not be untimely or unreasonably withheld. In addition, if
either party is required to make public disclosure of the Confidential Terms
pursuant to any law, rule or regulation of any government agency, including the
United States Securities and Exchange Commission or any national securities
exchange or self-regulatory organization, then in each case, the disclosing
party shall endeavor to obtain confidential treatment of such Confidential
Terms to the extent reasonably requested by the other party. Notwithstanding
the above, either party may disclose the Confidential Terms of this Agreement
(a) to its sublicensees in the Field under this Agreement, and (b) to third
parties for purposes of obtaining financing or in connection with the
evaluation or completion of a business merger or acquisition if such terms are
material in the opinion of such parties' legal counsel to the purposes of such
intended transaction; provided, however, that prior to such disclosure the
parties to whom such disclosure is made shall be subject to a written agreement
(or, if written agreements are not customary in any circumstance, otherwise
legally subject to obligations) prohibiting use and disclosure of terms as
provided herein. Each party shall limit such disclosure only to the extent
that such disclosure is reasonably necessary under the circumstances.
6.8 Equitable Remedies. Each party acknowledges that its
obligations under the non-disclosure and non-use provisions of this Agreement
are unique, and that, if it should default in its obligations under those
provisions of this Agreement, it would be extremely impracticable to measure
the resulting damages to the other party; accordingly, either party, in
addition to any other available rights or remedies, may xxx in equity for
specific performance or injunction, as the case may be, and, in such event,
each party expressly waives the defense that a remedy in damages will be
adequate to the other party.
6.9 Non-exclusive Remedy. The non-disclosure and non-use
provisions of this Agreement shall not be exclusive of, or serve as a
limitation on, any other rights and remedies that a party may have with respect
to its intellectual property, including any patent, trademark or copyright laws
as may be applicable.
6.10 Application. Each party recognizes that the other party
conducts its business internationally, and that the non-disclosure and non-use
provisions of this Agreement shall apply in every country in the world.
6.11 Survival of Obligations. The non-disclosure and non-use
provisions of this Agreement shall survive termination of this Agreement.
Nothing contained in this Agreement
21
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
22
shall be construed as to impose upon either party a duty to disclose any
Confidential Information to the other, except as may be specifically provided
in this Agreement.
6.12 Return of Confidential Information. Except as otherwise
expressly provided for herein, at the term or termination of this Agreement,
each party shall, upon the request and at the option of the producing party,
return to the producing party or destroy all documents or other media
containing Confidential Information produced to it and shall retain no copies.
The return or destruction of the Confidential Information shall be certified by
an officer of the receiving party within thirty (30) days of the request by the
producing party.
ARTICLE 7
Term and Termination
7.1 Term of this Agreement. This Agreement shall remain in effect
until the later of the expiration of the last patent licenses hereunder or ten
(10) years after the first commercial sale of a Semi-finished Product, Product
or Licensed Service by IntelliGene, unless sooner terminated as provided herein
(the "Term of this Agreement").
7.2 Termination by RPI for Cause. In the event of a material
breach of this Agreement by IntelliGene, and except as otherwise specifically
set forth in this Agreement, RPI shall give written notice of such breach to
IntelliGene and IntelliGene shall have sixty (60) days to cure such breach. If
such breach is not cured within sixty (60) days thereof, RPI shall have all
rights and remedies at law and equity to enforce this Agreement and to collect
all amounts due hereunder, and RPI shall have the right to terminate all
licenses granted to IntelliGene under this Agreement and/or to terminate this
Agreement. In addition, in the event that IntelliGene becomes the subject of a
voluntary or involuntary bankruptcy action that is not terminated within ninety
(90) days of filing during the Term of this Agreement, RPI shall have the right
to terminate the licenses granted to IntelliGene under this Agreement and/or to
terminate this Agreement and shall have no duty to pay any amounts hereunder
which have not accrued as of the expiration of such ninety (90) days. All
licenses granted to RPI by IntelliGene under this Agreement shall survive such
termination.
7.3 Termination by IntelliGene for Cause. In the event of a
material breach of this Agreement by RPI, and except as otherwise specifically
set forth in this Agreement, IntelliGene shall give RPI sixty (60) days to cure
such breach. In addition to the immediately foregoing:
7.3.1 Breach Under Article 4. In the event of a breach by
RPI of its obligations under Article 4, IntelliGene's sole remedies will be as
described in Section 4.10 or Section 4.13.
7.3.2 RPI's Bankruptcy. In the event that RPI becomes the
subject of a voluntary or involuntary bankruptcy action that is not terminated
within ninety (90) days of
22
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
23
filing during the Term of this Agreement, IntelliGene shall have the right to
terminate the licenses granted to the RPI under this Agreement and/or to
terminate this Agreement and shall have no duty to pay any amounts hereunder
which have not accrued as of the expiration of such ninety (90) days.
7.3.3 Remedies. Except as set forth herein, in the event
of any breach by RPI that is not cured within sixty (60) days thereof,
IntelliGene shall have all rights and remedies at law and equity to enforce
this Agreement and IntelliGene shall have the right to terminate all licenses
granted to RPI under this Agreement and/or to terminate this Agreement. All
licenses granted to IntelliGene by RPI under this Agreement shall survive such
termination.
7.4 Rights in Bankruptcy. All rights and licenses granted under
or pursuant to this Agreement are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code (the "Code"), licenses
of right to "intellectual property" as defined under Section 101 of the Code.
Either party, as licensee of such rights under this Agreement, shall retain and
may fully exercise all of its rights and elections under the Code. In the
event of the commencement of a bankruptcy proceeding by or against either party
under the Code, the party hereto which is not a party to such proceeding shall
be entitled to a complete duplicate of (or complete access to, as appropriate)
any such intellectual property and all embodiments of such intellectual
property, and same, if not already in their possession, shall be promptly
delivered to them (i) upon any such commencement of a bankruptcy proceeding
upon their written request therefor, unless the party subject to such
proceeding elects to continue to perform all of their obligations under this
Agreement or (ii) if not delivered under (i) above, upon the rejection of this
Agreement by or on behalf of the party subject to such proceeding upon written
request therefor by a non-subject party.
7.5 Rights and Duties Upon Termination. Termination of this
Agreement, for whatever reason, shall not affect any rights or obligations
accrued by either party prior to the effective date of termination. Without
limiting the generality of the foregoing, upon termination of this Agreement:
(a) each party shall immediately cease using the Confidential Information of
the other party and shall return any such Confidential Information, in whatever
form or format it was provided or then currently exists, to such party; and (b)
Articles 1, 4, 5, 6 and 9 shall survive, and any other provisions which by
their terms extend beyond termination.
ARTICLE 8
Representations and Warranties
8.1 Representations and Warranties of RPI. RPI represents and
warrants to IntelliGene as follows:
23
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
24
8.1.1 Organization of RPI. RPI is a corporation duly
organized, validly existing in good standing under the laws of the State of
Delaware and has the corporate power and authority and possesses all
governmental, regulatory and other permits, licenses and authorizations to
carry on its business as now conducted.
8.1.2 Authority Relative to this Agreement. The execution,
delivery and performance of this Agreement by RPI has been duly and effectively
authorized and approved by all necessary corporate action and no other
additional approval or consent is required. The consummation of the
transactions contemplated by this Agreement will not conflict with, violate or
result in a breach of a default in any (a) term, condition or provision of the
certificate or incorporation or bylaws of RPI; (b) any law, rule, regulation,
order of any court or governmental agency; or (c) any agreement, lease,
mortgage, note, contract, commitment of any kind, oral or written, formal or
informal to which RPI is a party.
8.1.2 Patents. The scope and duration of RPI's interest in
the patents and applications listed in Exhibit B is to be governed by the terms
of RPI ownership or existing licenses. RPI has no knowledge that any such
license agreements are under threat of cancellation or suspension for any
reason or that any basis for cancellation or suspension exists. To the best
knowledge of RPI, no act has occurred which would render any such patent, now
issued or when issued, invalid or unenforceable or would render RPI in breach
of any license under these patents. Except for an opposition filed in the
European Patent Office challenging certain of RPI's licensed patents, RPI has
received no notice of claims that any of the patents listed in Exhibit B are
invalid or infringing on the rights of others. Except as set forth above, RPI
makes no representations or warranties as to its rights, power and authority to
the RPI Technology or to grant to IntelliGene the licenses set forth herein or
that the practice of the RPI Technology will not infringe or violate any
domestic or foreign patent or intellectual property rights of a third party.
8.2 Representations and Warranties of IntelliGene. IntelliGene
represents and warrants to RPI as follows:
8.2.1 Organization of IntelliGene. IntelliGene is a
corporation duly organized, validly existing in good standing under the laws of
Israel and has the corporate power and authority and possesses all
governmental, regulatory and other permits, licenses and authorizations to
carry on its business as now conducted.
8.2.2 Authority Relative to this Agreement. The execution,
delivery and performance of this Agreement has been duly and effectively
authorized and approved by all necessary corporate action and no other
additional approval or consent is required. The consummation of the
transactions contemplated by this Agreement will not conflict with, violate or
result in a breach of a default in any (a) term, condition or provision of the
certificate of incorporation or bylaws of IntelliGene; (b) any law, rule,
regulation, order of any court or
24
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
25
governmental agency; or (c) any agreement, lease, mortgage, note, contract,
commitment of any kind, oral or written, formal or informal to which
IntelliGene is a party.
8.2.3 Patents. The scope and duration of IntelliGene's
interest in the patents and applications listed in Exhibit A is to be governed
by the terms of IntelliGene ownership or existing licenses. IntelliGene has no
knowledge that any such license agreements are under threat of cancellation or
suspension for any reason or that any basis for cancellation or suspension
exists. To the best knowledge of IntelliGene, no act has occurred which would
render any such patent, now issued or when issued, invalid or unenforceable or
would render IntelliGene in breach of any license under these patents.
IntelliGene has received no notice of claims that any of the patents listed in
Exhibit A are invalid or infringing on the rights of others. Except as set
forth above, IntelliGene makes no representations or warranties as to its
rights, power and authority to the IntelliGene Technology or to grant to RPI
the licenses set forth herein or that the practice of the IntelliGene
Technology will not infringe or violate any domestic or foreign patent or
intellectual property rights of a third party.
ARTICLE 9
Miscellaneous Provisions
9.1 Entire Agreement. This Agreement, including the recitals and
the Exhibits hereto, all of which are incorporated by reference herein,
constitutes the entire understanding and agreement between the parties with
respect to the subject matter hereof and supersedes all prior or
contemporaneous oral or written understandings, agreements, statements and/or
representations with respect thereto. This Agreement may not be amended except
in a writing identified as such and executed by both parties.
9.2 Assignment. Neither this Agreement nor any interest, right or
obligation hereunder shall be assignable by operation of law or otherwise by
IntelliGene without the prior written consent of RPI or by RPI without the
prior written consent by IntelliGene, which consents will not be unreasonably
withheld, except to a wholly owned subsidiary or to a successor in ownership of
all or substantially all of the business assets of the assigning party relating
to the subject matter of this Agreement if such successor shall expressly
assume in writing the performance of all the terms and conditions of this
Agreement to be performed by the assigning party.
9.3 Non-agency. Nothing contained herein shall be construed or
interpreted to make either party the authorized agent or representative of the
other or shall be construed to create expressly or by implication a partnership
or joint venture relationship between the parties. Neither party is authorized
to enter into an agreement or create any obligation on behalf of the other.
25
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
26
9.4 Non-use of Names. Except as expressly granted in this
Agreement, nothing herein shall confer on any party any right, title or
interest in or to any name, trademark, trade name or logo of the other party.
Neither party shall use the name, trademark, trade name or logo of the other
party nor refer to this Agreement in any press release, advertising,
promotional or sales literature, or otherwise for commercial purposes, without
the prior written consent of such party.
9.5 Compliance with Law. IntelliGene and RPI shall comply fully
with any and all applicable federal and state laws, rules and regulations,
local ordinances and any foreign laws, rules and regulations and shall obtain
and keep in effect all licenses, permits and other governmental approvals
incident to the development, use and commercialization of the rights granted
hereunder.
9.6 Force Majeure. No liability to any party shall result from
any delay in performance or nonperformance directly or indirectly caused by
circumstances beyond the control of the party affected, including acts of God,
fire, explosion, flood, earthquake, war, accident, labor trouble or inability
to obtain equipment, material or transportation, so long as the affected party
shall use all reasonable efforts to correct or mitigate the circumstances
causing such delay in performance or such nonperformance.
9.7 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY NOR
ANY OF ITS RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS
AFFILIATES FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER
IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE,
INCLUDING LOSS OF PROFITS OR REVENUE.
9.8 Indemnification. Except as otherwise provided herein, each
party shall indemnify and hold the other (including its agents, employees and
directors) harmless from and against any and all liability, damage, loss, cost
or expense (including reasonable attorney's fees) arising out of third-party
claims or suits related to activities conducted under this Agreement, but only
to the extent such claims or suits result from the negligence or willful
conduct of the party from whom indemnification is sought. To the extent any
claim or suit results from the activities of both parties, indemnification
shall be awarded only to the extent of their comparative contribution to the
claim or suit. Upon the assertion of any claim or suit, the party seeking
indemnification shall promptly notify the other and shall not settle that claim
or suit without the prior written consent of the party against whom
indemnification is sought. This paragraph will survive the termination of this
Agreement.
26
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
27
9.9 Arbitration. Any controversy concerning the interpretation of
this Agreement, or any breach thereof, shall be first referred to the
Presidents of RPI and IntelliGene for resolution. To the extent such
controversy is based upon a scientific disagreement between the parties, the
Presidents may select a neutral scientific expert who may advise the parties on
a resolution. If the Presidents cannot resolve such controversy, either party
may request that such controversy be settled by final and binding arbitration
in accordance with the then existing rules of the American Arbitration
Association, and judgment upon the award rendered by the arbitrators may be
entered in any court having jurisdiction over the party against whom the award
is entered. The arbitration shall be conducted in the Boulder, Colorado area.
Any such arbitration proceeding shall be heard before a panel of three
arbitrators, one to be designated by each party, and a third to be agreed upon
by the other two; provided, however, that if the two-party appointed
arbitrators are unable to agree on a third arbitrator within thirty (30) days
after the second arbitrator is appointed, the third arbitrator shall be
selected by the American Arbitration Association. The arbitrators may award
any remedy provided under this Agreement or otherwise available in law or in
equity and shall award to the prevailing party and assess against the other the
costs, arbitration fees (including the fees of the American Arbitration
Association and the arbitrators) and reasonable attorneys' fees incurred by the
prevailing party in connection with the dispute.
9.10 Notices. Any payment, notice or other communication required
or permitted to be given to any party under this Agreement shall be given in
writing and shall be delivered by hand, by registered or certified mail,
postage prepaid and return receipt requested, by telex, by facsimile
transmission or by overnight delivery service, addressed to the other party at
the following address or such other address as may be designated by such party
by notice from time to time:
Ribozyme Pharmaceuticals, Inc.
0000 Xxxxxxxxxx Xxxxx
Xxxxxxx, XX 00000
Attention: President
Copy to:
Xxxxxxx X. Xxxxx III
Rothgerber, Appel, Powers & Xxxxxxx LLP
0000 00xx Xxxxxx, Xxxxx 0000
Xxxxxx, XX 00000
IntelliGene, Ltd.
00 Xxxxxx Xxxxx
Xxxxxxx, XX 00000
Attention: President
27
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
28
Copy to:
Xxxxxx X. Xxxxxxxx
XxXxxxxxx, Will & Xxxxx
0000 X. Xxxxxx, X.X.
Xxxxxxxxxx, XX 00000
Any notice or communication given in conformity with this paragraph shall be
deemed effective when received by the addressee, if delivered by hand, by
telex, by facsimile or by overnight delivery service, and three days after
mailing, if mailed.
9.11 Non-waiver. No waiver of any right under this Agreement shall
be deemed effective unless contained in a writing signed by the party charged
with such waiver. The waiver of any breach or failure to perform any provision
of this Agreement by either party shall not be deemed to be a waiver of any
future breach or failure to perform or of the provision itself.
9.12 Governing Law. This Agreement shall be governed by and
construed in accordance with the substantive laws of the State of Colorado and,
to the extent necessary, by the laws and regulations of the United States of
America relating, for example, to patents and the licensing and regulation of
pharmaceutical products.
9.13 Captions; Construction. The captions provided in this
Agreement are for convenience only and will not affect its construction or
interpretation. Unless otherwise expressly provided, all references to
"Section" or "Sections" refer to the corresponding Section or Sections of this
Agreement. Unless otherwise expressly provided, the word "including" does not
limit the preceding words or terms.
9.14 Severability. If any provision of this Agreement is held by a
court of competent jurisdiction to be invalid, illegal or unenforceable, the
remaining provisions of this Agreement shall continue in full force without
being impaired or invalidated in any way, to the maximum extent possible
consistent with the original intent of the parties.
9.15 Representation by Counsel. The parties acknowledge that each
of them has been represented by counsel in connection with the negotiation and
drafting of this Agreement and that no rule of strict construction should be
applied to either of them as the drafter of all or any part of this Agreement.
9.16 Further Assurances. Each party agrees to execute such further
documents and do such other acts as may be necessary or desirable to carry out
the intent and purpose of this Agreement.
28
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
29
9.17 Counterparts. This Agreement may be executed in counterparts,
which shall be as effective as this Agreement when delivered and exchanged
between the parties.
9.19 Publicity Announcements. All publicity, press releases and
other announcements relating to this Agreement, and the transactions
contemplated hereby, shall be reviewed and approved in advance by both parties.
IN WITNESS WHEREOF, the parties hereto have duly executed this
Agreement as of the date first written above.
INTELLIGENE
BY: /s/ Xxxxx X. Xxxxxxxx
President
RIBOZYME PHARMACEUTICALS, INC.
BY: /s/ Xxxxx X. Xxxxxxxxxxxxxx
President
29
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
30
Exhibit A - IntelliGene Patents and Patent Applications
Date: October 24, 1996
TO WHOM IT MAY CONCERN
Dear Sirs,
Re: IntelliGene's Patent Applications Portfolio
Our Ref: G/IntelliGene
Our office is handling all of IntelliGene's patent applications in
Israel and abroad. Currently, all of IntelliGene's applications are still
pending.
The following is a brief summary of IntelliGene's patent applications,
specifying their subject matter and legal status. Group I, Group II and Group
III hereinbelow refer to three groups of corresponding applications. Within
each group all applications are essentially identical. Applications IV, V and
VI refer to single applications.
Group I: Detection of Nucleic Acid Sequences
[ ]
Status: Israel: IL 105895 - (priority application): Last Official
Communication of June 17, 1996, raised only formal issues, which were dealt
with. Notification of Allowance is expected by December 1996 - February 1997,
and grant three months thereafter (provided no opposition is filed).
International: PCT Application US 94/06039 - the Written Opinion by
the International Examiner, which serves as a recommendation for all designated
countries was extremely favorable, withdrawing all objections of prior art and
allowing a very broad scope of protection.
Canada: 2164320 - pending. No Official Communication issued.
Europe: 94919280 - pending. No Official Communication issued.
U.S.: 08/556940 - pending. No Official Communication issued.
30
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
31
Group II: Ribozymes
[ ]
International Application PCT/96/062380 - a Search Report was issued
citing only Innovir's Application WO 94/1383 and Intelligene's prior
application of Group I. Preliminary Examination is expected by November 1996.
Group III: Improvement in a method for the detection of nucleic acid
sequences
Subject matter: Very similar to the invention of Group I, the
difference being:
(a) [ ]
(b) [ ]
(c) [ ]
Status: Israel: IL 95403 - pending. No Official Communication
issued.
International: PCT US 95/111957 - Search Report was issued citing
U.S. 5,369,003 and WO 91/04350 (Cambridge Biotech Corporation). Preliminary
examination expected by December 1996 - January 1997.
Group IV: Cleavage of mismatched hybrids
[ ]
Status: Israel: IL I09906 - pending. No Official Communication
issued.
Group V: Detecting nucleic acid sequences by using a series of probes
[ ]
Status: Xxxxxx XX 000000 - pending. No Official Communication
issued. End of priority year - December 8, 1996.
Group VI: Precursor ribozymes prepared by in vitro evolution
[ ]
Status: Israel: IL 102486 - pending. No Official Communication
issued. End of priority year - August 26, 1996.
31
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
32
Our office is also handling a U.S. Application No. 08/399319 in the
name of Xx. Xxxxx Xxxxx. IntelliGene maintains certain rights associated with
this application.
[ ]
Status U.S. Application 08/399379 - The application is currently
under examination. The Examiner requires to file a continuation in part (CIP).
32
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
33
Exhibit B - RPI Patents
CECH PATENTS - US
----------------------------------------------------------------------------------------------------
TITLE/INVENTION PATENT NO. LICENSER/OWNER
----------------------------------------------------------------------------------------------------
1 RNA Ribozyme Polymerases, US 4,987,071 U.S. Biochemical
Dephosphorylases, Restriction Corporation
Endoribonucleases and Methods
----------------------------------------------------------------------------------------------------
2 RNA Ribozyme Polymerases, and Methods US 5,037,746 U.S. Biochemical
Corporation
----------------------------------------------------------------------------------------------------
3 RNA Ribozyme Polymerases, US 5,093,246 U.S. Biochemical
Dephosphorylases, Restriction Corporation
Endoribonucleases and Methods
----------------------------------------------------------------------------------------------------
4 RNA Ribozyme Restriction US 5,116,742 U.S. Biochemical
Endoribonucleases and Methods Corporation
----------------------------------------------------------------------------------------------------
5 RNA Ribozyme Which Cleaves Substrate RNA US 5,354,855 U.S. Biochemical
Without Formation of a Covalent Bond Corporation
----------------------------------------------------------------------------------------------------
6 RNA Ribozyme Polymerases, US 5,591,610 U.S. Biochemical
Dephosphorylases, Restriciton Corporation
Endoribonucleases and Methods
----------------------------------------------------------------------------------------------------
7 Site Specific Cleavage of Single- US 5,180,818 U.S. Biochemical
Stranded DNA Corporation
----------------------------------------------------------------------------------------------------
CECH PATENTS - FOREIGN
----------------------------------------------------------------------------------------------------
1 RNA Ribozyme Polymerases, European Patent U.S. Biochemical
Dephosphorylases, Restriction No. 0 291533 B1 Corporation
Endoribonucleases and Methods
----------------------------------------------------------------------------------------------------
2 RNA Ribozyme Polymerases, Japanese Patent U.S. Biochemical
Dephosphorylases, Restriction No. 2530906 Corporation
Endoribonucleases and Methods
----------------------------------------------------------------------------------------------------
3 Site Specific Cleavage of Single- Australian Patent U.S. Biochemical
Stranded DNA
----------------------------------------------------------------------------------------------------
4 Ribozyme Inhibitors Australian Patent U.S. Biochemical
----------------------------------------------------------------------------------------------------
5 Ribozyme Inhibitors European Patent U.S. Biochemical
----------------------------------------------------------------------------------------------------
33
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
34
Exhibit B - RPI Patents
ADDITIONAL PATENTS - U.S.
----------------------------------------------------------------------------------------------------
1 Assay for Ribozyme Target Site US 5,525,468 RPI
Accessibility
----------------------------------------------------------------------------------------------------
2 Permeability Enhancers for Ionic US 5,583,020 RPI
Therapeutic Polynucleotides
----------------------------------------------------------------------------------------------------
3 Enzymatic RNA Targeted Against US 5,599,704 RPI
erbB-2/neu RNA
----------------------------------------------------------------------------------------------------
4 Enzymatic RNA Targeted Against US 5,599,706 RPI
apo (a) RNA
----------------------------------------------------------------------------------------------------
ADDITIONAL PATENTS - FOREIGN
----------------------------------------------------------------------------------------------------
1 Modified Ribozymes Australian Patent Max-Xxxxxx-Gesellschaft
No. 649074
----------------------------------------------------------------------------------------------------
2 Modified Ribozymes European Patent Max-Xxxxxx-Gesellschaft
No. 0 552 178 B1
----------------------------------------------------------------------------------------------------
34
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
35
Exhibit C - Target Diseases
35
Confidential portions ( [ ] ) have been omitted pursuant to regulation
240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed
separately with the Commission.
