CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. Sections 200.80(b)4, AND 240.24b-2
[ISIS PHARMACEUTICALS LOGO]
-------------------------------------------------------------------------------
AMENDED & RESTATED IDT-ISIS
LICENSING AGREEMENT
By and between
ISIS PHARMACEUTICALS, INC.
0000 Xxxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxxxx 00000
Hereinafter referred to as "ISIS"
and
INTEGRATED DNA TECHNOLOGIES, INC
0000 Xxxxxxxxxx Xxxx, Xxxxxxxxxx, Xxxx 00000
Hereinafter referred to as ("IDT")
Dated as of
DECEMBER 4, 2001.
--------------------------
1
RECITALS
WHEREAS, ISIS and IDT entered into a Licensing Agreement dated as of March
12, 1999, (the "Original Agreement") which contains certain limitations in
the licenses obtained by each Party; and,
WHEREAS, ISIS and IDT would mutually benefit from expanding and clarifying
the scope of licenses obtained in the Original Agreement to include more
broad sublicensing rights for ISIS, including rights in the fields of
functional genomics, target validation, and antisense drug development, and
to provide IDT with rights under ISIS's RNase H suite of patents for sales of
oligonucleotides;
NOW, THEREFORE the parties hereby agree to replace and irrevocably supercede
the Original Agreement with this Amended and Restated IDT-ISIS Licensing
Agreement (hereinafter the "Restated Agreement") as follows:
ARTICLE I
INTERPRETATION & EFFECT
1.1 SUPERCEDING AGREEMENT. It is the intent of the Parties to
irrevocably supercede the Original Agreement with this Restated
Agreement. The rights and obligations of the parties are to be
exclusively defined by the terms, conditions, rights, and
obligations as expressed herein. All existing and future rights and
obligations of the Parties, including specifically all
post-termination rights and obligations, contained in the Original
Agreement are hereby null and void. In the event any term of the
Original Agreement is not specifically superceded, modified or
replaced by a corresponding term of the Restated Agreement, it shall
be construed as a deliberate omission by the Parties.
1.2 EFFECTIVE DATE; WAIVERS. In exchange for the good and valuable
consideration received by each Party described herein, each Party
hereby irrevocably waives all claims to royalties or related damages
arising out of the performance or conduct of the other Party prior
to the Restated Agreement Effective Date, as hereinunder defined.
The execution of this Restated Agreement shall not be interpreted as
requiring either the repayment of licensing fees paid by ISIS
pursuant to the Original Agreement, nor shall it be interpreted as
requiring refund of such payments by IDT.
ARTICLE 2
DEFINTIONS
The following terms when used in this Restated Agreement shall be given the
meanings contained herein:
2
2.1 "Academic Market" shall mean end-users employed by and located at or
in academic, university, government, and other 501(c)(3) registered
not-for-profit organizations; provided however that specifically
excluded from this definition shall be those end-users at such
institutions whose research is directly funded by a for-profit
corporation for the purpose of drug discovery, drug development, or
target validation/gene functionalization wherein the funding
corporation has a specific legal interest or right to the data and
information of the funded research.
2.2 "Affiliates" shall mean any corporation, company, partnership, joint
venture or other entity, which controls, is controlled or under
common control with Isis or IDT as the case may be, and in the case
of Isis shall also mean and include Pantheco, APS. For the purposes
of this definition, control shall mean the direct or indirect
ownership of at least fifty percent (50%) or, if less than fifty
percent (50%), the maximum percentage as allowed by applicable law
of (a) the stock shares entitled to vote for the election of
directors; or (b) ownership interest.
2.3 "Antisense Drug Development Sublicenses" shall mean
licenses/sublicenses under the Xxxxxx Patents to third parties to
pursue all Medical Applications, which are not based on ISIS
Licensed Products. Antisense Drug Development Sublicense holders
shall have the limited right to issue sublicenses as a Product
Sublicense under the Xxxxxx Patents to third-parties.
2.4 "Antisense Oligonucleotide" shall mean a polynucleotide,
oligonucleotide, or oligonucleotide analog, which hybridizes in a
sequence specific manner under physiological conditions to RNA
forming an RNA-DNA duplex, which duplex acts to modulate the
production of a targeted gene product. An antisense oligonucleotide
analog may include naturally occurring or non-natural heterocycles,
sugar and/or backbone linkages, and may be a molecule in which the
sugar may be absent, in which the backbone linkage may be phosphate
based, amide based, or based on other chemistries and which may or
may not include stem loop or structural units.
2.5 "Competing Oligonucleotide Supplier" shall mean any entity having a
license from ISIS or its Affiliates to manufacture and/or sell
Antisense Oligonucleotides for use in Research Applications.
2.6 "Confidential Information" shall mean information disclosed pursuant
to an obligation contained in this Restated Agreement, including,
without limitation, proprietary information and materials (whether
or not patentable) regarding a Party's technology, products,
business information or objectives, which is designated as
confidential in writing by the disclosing Party, whether by letter
or by the use of an appropriate stamp or legend, prior to or at the
time any such information is disclosed by the disclosing Party to
the other Party.
2.7 "Fee for Service FGTV Licenses" shall mean sublicenses under the
Xxxxxx Patents to commercial entities offering antisense functional
genomics/target validation products or services, including but not
limited to database subscriptions, to third-parties. Specifically
3
excluded from this definition shall be licenses under the Xxxxxx
Patents to Competing Oligonucleotide Suppliers and other entities
that sell oligonucleotides as an independent product (i.e, sales of
oligonucleotides that are not related to the provision of a
complementary functional genomic or target validation service to the
third-party purchasing the oligonucleotides).
2.8 "IDT Licensed Commercial Product" shall mean and include any
diagnostic, therapeutic, or prophylactic material, composition of
matter, or method that either (a) is covered by a Valid Claims of
any patent within the definition of the Xxxxxx Patents; or (b) the
manufacture, use or sale of which would constitute, but for the
license granted pursuant to this Restated Agreement, an infringement
of any Valid Claim within the definition of the Xxxxxx Patents.
2.9 "In-House FGTV Licenses" shall mean licenses under the Xxxxxx
patents to end-users at any for-profit commercial entity using
Antisense Oligonucleotides to use antisense-based functional
genomic/target validation products and services for that licensee's
internal research and development.
2.10 "ISIS Academic Patents". Those patents defined, described or listed
on Exhibit 1, as it may be expanded from time to time at ISIS's
discretion. {Specifically INCLUDED in the definition of the "ISIS
Academic Patents" are U.S. Patents [***] and the two allowed patent
applications listed on Exhibit 1 herein, and all existing and future
patent applications or patents that specifically claim the RNase H
Mechanism of Action, which patents or applications ISIS can license
or sublicense to IDT that IDT may require to make, use or sell
Antisense Oligonucleotides for the Academic Market. Specifically
EXCLUDED from the definition of "ISIS Academic Patents" shall be all
patents or relevant patent claims related to clinical formulations
and administration of oligonucleotides (including, without
limitation, methods and reagents for the clinical delivery of
oligonucleotides); gene-related patents, including without
limitation patents to specific gene structures, gene targets and
methods of treatment; 2' MOE technology, and any other patents
and/or claims regarding chemistries not listed on Exhibit 1.}
2.11 "ISIS Licensed Product" an ISIS oligonucleotide drug or drug
candidate molecule licensed to a third party for further
development, commercialization, manufacture or distribution of the
oligonucleotide drug or drug candidate molecule.
2.12 "Licensed Purchaser of RNase H Oligonucleotides " shall mean a
third-party for-profit commercial entity that has obtained from ISIS
a license to use RNase H Oligonucleotides.
2.13 "Medical Applications" shall mean diagnostic products, therapeutic
and prophylactic drugs or vaccines, intended for the diagnosis,
prevention, or treatment of disease in humans, animals or plants and
all discovery, research, development, and commercialization efforts
to support those uses, including without limitation, elucidation of
gene function and target validation.
4
2.14 "Net Sales" shall mean the gross receipts received by ISIS or its
Affiliates or sublicensees, as appropriate, for the sale of IDT
Licensed Commercial Products by ISIS and its Affiliates or its
sublicensees, as appropriate, less the following deductions:
(i) Prompt payment or other trade or quantity discounts
actually allowed and taken in such amounts as are customary
in the trade;
(ii) Commissions paid or allowed to distributors and agents who
are independent third parties other than such parties who
are solely performing detailing functions;
(iii) Amounts paid or credited by reason of timely rejection or
returns;
(iv) Taxes (other than franchise or income taxes on the income
of Isis actually paid or withheld;
(v) Allowances including any allowances for bad debt. Provided
that upon the extinguishment of any such allowance, the
extinguishment will be determined to be a receipt;
(vi) Transportation and delivery charges, including insurance
premiums actually incurred;
Notwithstanding the foregoing, amounts received by ISIS or its
Affiliates or sublicensees for the sale of IDT Licensed Commercial
Products among ISIS, its Affiliates or sublicensees whether for
their internal use or for resale or other disposition will not be
included in the computation of Net Sales hereunder. For purposes of
this Restated Agreement a distributor will not be deemed a
sublicensee and sales by ISIS, its Affiliates or sublicensees to a
distributor will not be subject to royalties.
2.15 "Original Agreement" shall mean the Licensing Agreement executed by
IDT and ISIS with an effective date of March 12, 1999 (attached
hereto as Attachment 1).
2.16 "Product Sublicense" shall mean a sublicense under the Xxxxxx
Patents to further develop, commercialize, manufacture or distribute
an oligonucleotide drug or drug candidate molecule, which sublicense
is granted by either: (a) ISIS under Article 3 of the Restated
Agreement; or (b) an Antisense Drug Development Sublicense holder.
2.17 "Restated Agreement Effective Date" shall be the day of last dated
signature of a signatory to this Restated Agreement.
2.18 "RNase H Mechanisms of Action" means methods of using RNase H
enzymes to cleave a targeted RNA in cells.
2.19 RNase H Oligonucleotides" shall mean an Antisense Oligonucleotide
that acts by the RNase H Mechanism of Action.
5
2.20 "Research Applications" shall mean all non-therapeutic uses of
oligonucleotides including but not limited to all in vitro cell
culture, tissue culture, laboratory animal, plant and microorganism
studies.
2.21 "Xxxxxx Patents" shall mean and include [***] and all divisionals,
reissues, and foreign counterparts derived from these patents and
patent applications.
2.22 "Valid Claim" shall mean a claim of an issued patent that has not
been ruled invalid or unenforceable by a court of competent
jurisdiction in an unappealed or unappealable decision.
ARTICLE 3
IDT GRANT OF LICENSES TO ISIS
3.1 MEDICAL APPLICATIONS. IDT grants to Isis, a non-exclusive,
royalty-bearing, worldwide license to make, have made, use, offer to
sell, import, and sell IDT Licensed Commercial Products for all
Medical Applications (the "Medical Applications License"). Isis may
at its option extend the licenses granted hereunder to an Affiliate,
in which event a sublicensing fee will not be required.
3.1.1 PRODUCT SUBLICENSES. ISIS may grant written sublicenses
under this Medical Applications License to third parties to
further develop, commercialize, manufacture or distribute
an oligonucleotide drug or drug candidate molecule (a
"Product Sublicense" and/or Product Sublicensee). Isis will
inform IDT of the identity of any such Product Sublicensee
and the nature of such sublicense within 60 days of
execution of such sublicense and warrant to IDT that the
grant of rights to any sublicensee will conform to the
grant of rights hereunder. Any agreement granting a
sublicense shall state that the sublicense is subject to
the terms of this Restated Agreement. Isis shall have the
same accounting and reporting responsibilities for the
activities of any sublicensee, as if the activities were
directly those of Isis.
3.2 FUNCTIONAL GENOMICS AND TARGET VALIDATION LICENSE. IDT grants to
ISIS a fully paid-up, non-royalty bearing, worldwide, exclusive
license (except with respect to IDT, and with respect to rights
already granted to [***] (as described in section 3.2.1 hereunder)
under the Xxxxxx Patents to make, have made, use, import, offer to
sell, and sell all functional genomics and target validation
products and services ("the FGTV License").
3.2.1 FEE-FOR-SERVICE FGTV SUBLICENSES. IDT grants to ISIS the
exclusive right, even as to IDT, to issue Fee-for Service
FGTV Licenses under the Xxxxxx Patents to third parties.
ISIS will have no royalty or other contingent payment
obligations to IDT with respect to sublicenses granted
under this provision. ISIS acknowledges that prior to the
execution of this Restated Agreement, [***] has obtained a
Fee for Service FGTV license from IDT, the scope and
validity of which is not affected by the exclusive rights
granted ISIS in 3.2.1, herein. IDT agrees that it shall not
6
amend or expand the [***] attached hereto as Exhibit 3,
without the prior written approval of ISIS.
3.2.2 IN-HOUSE FGTV SUBLICENSES. IDT grants to ISIS the exclusive
right even as to IDT to issue future In-House FGTV Licenses
under the Xxxxxx Patents to third parties. ISIS will have
no royalty or other contingent payment obligations to IDT
with respect to sublicenses granted under this provision.
3.2.3 IDT RETAINED RIGHTS. IDT reserves all rights under the
Xxxxxx Patents to make, use and sell oligonucleotides and
other products and services.
3.3 ANTISENSE DRUG DEVELOPMENT SUBLICENSES. IDT grants to ISIS a
term-limited exclusive license (even as to IDT) to issue Antisense
Drug Development Sublicenses under the Xxxxxx patents to
third-parties. ISIS's shall pay IDT a [***] initial license payment
pursuant to Article 5 herein, within ten (10) days of the Restated
Agreement Effective Date, to maintain the exclusivity of the license
for a period of [***] years following the Restated Agreement
Effective Date.
3.3.1 OPTION TO EXTEND EXCLUSIVITY. ISIS will have the option to
extend the exclusivity of the license for the duration of
the last to expire of the Xxxxxx Patents for an additional
[***]payment, such payment to be made within thirty (30)
days of the expiration of the initial [***] period, stated
herein.
3.3.2 EFFECT OF LOST EXCLUSIVITY. Should ISIS not exercise the
option in 3.3.1 ISIS's exclusive right to issue Antisense
Drug Development Sublicenses will revert to a non-exclusive
right, without further initial payment obligation to IDT.
In that event, IDT shall have the right to issue Antisense
Drug Development Sublicenses under the Xxxxxx Patents to
third-parties. In this instance, notwithstanding the
provisions of 3.2.2., IDT shall have the right to grant an
In-House FGTV Licenses under the Xxxxxx Patents as a part
of an Antisense Drug Development Sublicense.
3.3.3 SUBLICENSING PAYMENTS. For each Antisense Drug Development
sublicense issued by ISIS under this provision, ISIS will
pay IDT or will obligate the Antisense Drug Development
Sublicense Holder to pay IDT, the initial sublicensing fees
and Royalties as established in Appendix A, attached, and
to comply with or fulfill all necessary reporting and
accounting obligations as defined in this Restated
Agreement. ISIS's initial license payments (specifically
the [***] payment and the optional [***] payment) made
under this provision will be creditable against initial
sublicensing fees and royalty payments owed to IDT pursuant
to the issuance of Antisense Drug Development Sublicenses.
3.3.4 PRIOR LICENSES. ISIS acknowledges that prior to this First
Amendment, Hybridon Inc., and Epigenesis Pharmaceuticals,
Inc., have each obtained an Antisense Drug Development
Sublicense from IDT, the scope and validity of which is not
affected by the exclusive rights granted ISIS in paragraph
3.3 herein. IDT agrees that it shall not amend or expand
either of such licenses without ISIS's prior written
approval.
7
3.4 NOTICE OBLIGATIONS. To minimize confusion with respect to the
sublicensing activities of ISIS, or its sublicensees, ISIS agrees to
the following:
3.4.1 NOTICES TO IDT OF SUBLICENSES. Isis shall provide IDT with
written notice of any sublicense granted pursuant to this
Restated Agreement within ten (10) days after the grant of
such sublicense, such written notice specifying the name of
the sublicensee, the date of the sublicense, and whether
such sublicense is a Product Sublicense, a Fee-for-Service
FGTV Sublicense, an In-House FGTV Sublicense, or an
Antisense Drug Development Sublicense. With respect to
Antisense Drug Development Sublicenses, ISIS will pay or
cause the Antisense Drug Development Sublicense Holder to
pay, the initial sublicensing fee to IDT within twenty (20)
days of the execution of such sublicense.
3.4.2 NOTICE TO IDT OF LICENSED PURCHASERS. Along with notice of
an In-House FGTV Sublicense required in 3.4.1, Isis shall
provide to IDT, a complete list of Licensed Purchasers of
RNase H Oligonucleotides upon the written request of IDT,
such requests not to exceed two per calendar year.
3.4.3 [***]
ARTICLE 4
LICENSES TO IDT
4.1 IDT SALES TO THE ACADEMIC MARKET. ISIS grants to IDT a worldwide,
fully paid-up, non-royalty bearing, non-exclusive license under the
ISIS Academic Patents to make, have made, use, import, offer to
sell, sell, and have sold oligonucleotides and other related
research products to the Academic Market.
4.2 RESTRICTIONS ON SALES. Within thirty (30) days of the Restated
Agreement Effective Date, and consistent with the provisions of
section 3.2.1 herein, IDT agrees to suspend sales of any RNase H
Oligonucleotides to third-parties except as may be required by IDT's
existing obligations, for incorporation into antisense-based
functional genomics/target validation products or incorporation into
a commercial service, unless IDT receives the prior written
authorization from ISIS.
4.3 THIRD-PARTY OBLIGATIONS. IDT acknowledges that ISIS may have certain
financial and reporting obligations under licenses it has obtained
from third parties to certain patents included in the definition of
ISIS Academic Patents. IDT agrees to either pay all associated
financial obligations (except upfront licensing fees) and fulfill
all associated legal/reporting obligations that may be required of
ISIS to a third-party for sales of products by IDT under the
sublicense, or IDT shall refuse the sublicense under such patent(s)
and it shall be deleted from the Academic Patents. ISIS shall
promptly notify IDT of the precise nature of all such obligations so
that IDT can make the required election(s).
8
4.4 ISIS RETAINED RIGHTS. Notwithstanding the licenses granted to IDT
herein, Isis shall retain all rights, however characterized under
all ISIS Academic Patents and the RNase H Suite of Patents,
including without limitation, rights to use, have used, make, have
made, import, have imported, offer to sell, sell, and have sold
oligonucleotides and related technologies for any and all
applications.
4.5 [***]
ARTICLE 5
CONSIDERATION
5.1 GUARANTEED PAYMENTS. Within five (5) days of the Restated Agreement
Effective Date, ISIS will pay to IDT the sum of $3,500,000
structured as follows:
(i) $3 million in non-refundable licensing fees;
(ii) $500,000 for exclusive rights to issue Antisense Drug
Development sublicenses under section 3.3 herein,
In addition, ISIS will pay IDT $350,000 in non-refundable licensing
fees on or before each of the first four (4) anniversary dates of
the Restated Agreement Effective Date (i.e. four anniversary
payments totaling $1.4 million).
5.2 CONTINGENT ROYALTY PAYMENTS. In further consideration for the
Medical Application License and the exclusive right to issue
Antisense Drug Development Sublicenses granted herein, Isis agrees
to pay IDT [***] of Net Sales from each IDT Licensed Commercial
Product sold by Isis, or its Sublicensees, however characterized,
beginning with the first sale to any unrelated third party,
according to the terms and conditions of Article 6 herein.
5.3 CONTINGENT SUBLICENSING FEES. ISIS shall pay to IDT, or shall cause
the sublicensee to pay to IDT, the initial licensing fees as defined
in Appendix A for all Antisense Drug Development sublicenses issued
by ISIS under this Restated Agreement.
ARTICLE 6
ACCOUNTING /PAYMENTS
6.1 QUARTERLY ESTIMATES. For each calendar year in which there are Net
Sales of IDT Licensed Commercial Products ISIS shall prepare, or
cause its Affiliates or sublicensees to prepare, deliver and pay to
IDT a quarterly estimate of the royalty payments due to IDT under
Section 5.1 herein, within sixty (60) days following the last day of
the first, second, and third quarters of each calendar year of ISIS.
6.2 ANNUAL REPORT. Within ninety (90) days following the last day of
each calendar year, ISIS, its Affiliates, or licensees, whichever is
applicable, shall prepare and deliver an annual report of the total
royalty payments due to IDT for the calendar year expired. The
reporting party shall tender payment of the balance owed for the
year, including all payments owed for the fourth quarter of the year
expired, and any necessary adjustments
9
to the quarterly estimate payments previously paid. Each quarterly
estimate or annual payment shall be accompanied by a statement of
account which shall indicate the estimated or actual Net Sales, as
the case may be, by the reporting party for the previous period and
shall show the amount of royalties due IDT with sufficient detail to
enable confirmation of the calculations by IDT.
6.3 PAYMENT CURRENCY. Except as otherwise directed, all amounts owing to
IDT under this Restated Agreement shall be paid in U.S. dollars to
IDT at the addresses provided or via wire transfer to a specified
IDT account. All royalties owing with respect to Net Sales stated in
currencies other than U.S. dollars shall be converted at the rate
shown in the Wall Street Journal on the last day of the quarter for
which the royalty is due, or shall be converted according to the
terms governing conversion for an Isis sublicensee.
6.4 RECORDKEEPING. Isis, its Affiliates and its sublicensee(s) shall
keep books and records sufficient to verify the accuracy and
completeness of the accounting referred to above, including without
limitation sales, accounts receivable, and invoice records relating
to IDT Licensed Commercial Products. Such books and records shall be
preserved for a period not less than five (5) years after they are
created during and after the term of this Restated Agreement.
6.5 AUDITING/DEFICIENCIES. Isis, its Affiliates, and its sublicensee(s)
shall take all steps necessary so that IDT may, within sixty days of
its request, review and copy all the books and records at a single
U.S. location to verify the accuracy of Isis and its
sublicensee(s)'s accounting. Such review shall be made not more than
once each calendar year, upon reasonable notice and during regular
business hours, at the expense of IDT by a certified public
accountant to whom there is no reasonable objection by either party.
If a royalty payment deficiency for a calendar year is determined,
the reporting party shall pay the royalty deficiency outstanding
within thirty (30) days of receiving written notice thereof, and
shall reimburse IDT for the cost of the inspection.
ARTICLE 7
WARRANTIES/INDEMNIFICATIONS.
7.1 NO CONSEQUENTIAL DAMAGES. Neither Party shall be liable to the other
Party, its Affiliates, sublicensees, successors, or assigns for any
loss of profits, loss of business, interruption of business, nor for
indirect, special or consequential damages of any kind under this
Restated Agreement.
7.2 WARRANTY OF AUTHORITY. The parties warrant each has the right to
grant the licenses granted to the other party in this Restated
Agreement. IDT warrants that it does not own or control any patents
or patent applications with claims to antisense compounds and/or
methods not already disclosed in the definition of the "Xxxxxx
Patents".
7.3 WARRANTY DISCLAIMERS. Except as expressly set forth herein, IDT and
Isis make no representations, extend no warranties of any kind,
either express or implied, and assume no responsibilities whatsoever
with respect to use, sale, or other disposition by the other
10
party, its Affiliates, sublicensees or their vendees or other
transferees, of IDT Licensed Commercial Products. EXCEPT AS
EXPRESSLY SET FORTH HEREIN, NOTHING IN THIS RESTATED AGREEMENT, NOR
ANY PRIOR COMMUNICATION, SHALL BE CONSTRUED AS:
(i) A WARRANTY OR REPRESENTATION BY IDT OR ISIS AS TO THE
VALIDITY OR SCOPE OF ANY OF THE PATENTS CONTAINED
WITHIN THE DEFINITIONS OF THE XXXXXX PATENTS AND ISIS
ACADEMIC PATENTS, RESPECTIVELY;
(ii) A WARRANTY OR REPRESENTATION THAT ANYTHING MADE, USED,
SOLD OR OTHERWISE DISPOSED OF UNDER THE LICENSES
GRANTED IN THIS RESTATED AGREEMENT WILL OR WILL NOT
INFRINGE PATENTS OF THIRD PARTIES; OR
(iii) AN OBLIGATION TO FURNISH ANY KNOW-HOW NOT PROVIDED IN
THE XXXXXX PATENTS OR THE ISIS ACADEMIC PATENTS OR ANY
SERVICES OTHER THAN THOSE SPECIFIED IN THIS RESTATED
AGREEMENT OR RELATED AGREEMENTS.
7.4 INDEMNIFICATION. Isis and IDT shall at all times during the term of
this Restated Agreement and thereafter, indemnify, defend and hold
each other, the University of Iowa Research Foundation/University of
Iowa, and the authors and inventors of the Xxxxxx Patents and the
Isis Academic Patents harmless against all claims and expenses,
including legal expenses and reasonable attorneys fees, arising out
of the death of or injury to any person or persons or out of any
damage to property and against any other claim, proceeding, demand,
expense and liability of any kind whatsoever resulting from the
production, manufacture, sale, use, lease, consumption or
advertisement of products or processes arising from any right or
obligation of IDT or Isis, or their Affiliates, or any of its
sublicensee(s) granted herein. Notwithstanding the above, IDT and
Isis at all times reserves the right to retain counsel of its own to
defend IDT's or Isis's interest.
ARTICLE 8
CONFIDENTIAL INFORMATION
8.1 CONFIDENTIALITY. Isis and IDT each agrees to treat as confidential
and to use only in the conduct of its business, all Confidential
Information disclosed to it by the other party.
8.2 NON-DISCLOSURE AND NON-USE. Isis and IDT each agrees not to disclose
any of the Confidential Information received from the other party to
any unauthorized third party and not to use any of the Confidential
Information except to fulfill the terms of the Restated Agreement,
for a period of five (5) years from the receipt of the Confidential
Information.
8.3 RELEASE FROM RESTRICTIONS. All information which is characterized as
Confidential Information shall cease to be confidential and the
receiving party shall be released from their respective obligations
under sections 8.1 and 8.2 herein, if such information (i) is
legally known to or was in the possession of the receiving party at
the time of the disclosure; (ii) legally is or has become part of
the public domain through no act or omission of the receiving party;
(iii) has been disclosed to the recipient by a third party
11
without restriction as to the use or disclosure of the information:
(iv) is available to the general public as a result of a
governmentally required release or disclosure.
ARTICLE 9.
TERM AND TERMINATION.
9.1 TERM. The term of this Restated Agreement shall extend until the
last patent to expire included within the Xxxxxx Patents or Isis
Academic Patents, whichever expires later.
9.2 TERMINATION FOR BREACH. In the event either party shall materially
breach any of the terms, conditions and agreements contained in this
Restated Agreement, then the alleging party may, at its election,
notify the other party of the alleged breach giving the other party
thirty (30) days written notice to cure the breach or begin good
faith negotiations to resolve such alleged breach. If the alleged
breach is not resolved to the satisfaction of the alleging party
within thirty (30) days of the first giving of notice the alleging
party may, at its option, bring arbitration proceedings under
Article 12. In the event of a good faith dispute about monetary
obligations, the notified party will pay any undisputed amounts to
the alleging party and pay any disputed amounts into escrow pending
resolution of such dispute, with payment to be made to the
prevailing party. The licenses granted hereunder are not terminable
except in the event of bankruptcy of a Licensee, subject to Sections
9.3 9.4, and 9.5, and the continuing rights of sublicensees.
9.3 ELECTIVE TERMINATION FOR BANKRUPTCY. In the event either Party shall
become insolvent, bankrupt or subject to the provisions of the
United States Bankruptcy Code, or makes any assignment for the
benefit of creditors, or ceases to carry on business as a going
concern, then the other Party shall have the right but not the
obligation to terminate the licenses granted by the termination
party in this Restated Agreement; provided however, that Xxxx xxxx
have the right to grant to its sublicensee(s), the power to assume
Isis's rights and obligations under its licenses, and
correspondingly Isis, and its successor in interest, however
organized, shall, to the extent permitted by law, maintain the
licenses granted to IDT pursuant to this Restated Agreement.
9.3.1 BANKRUPTCY RIGHTS. In the event that this Restated
Agreement is terminated by a Party hereto or its receiver
or trustee under applicable bankruptcy laws due to such
Party's bankruptcy, then all rights and licenses granted
under or pursuant to this Restated Agreement by such Party
to the other Party are, and will otherwise be deemed to be,
for purposes of Section 365(n) of the Bankruptcy code and
any similar law or regulation in any other country,
licenses of rights to "intellectual property" as defined
under section 101(35A) of the Bankruptcy Code. The Parties
agree that all intellectual property rights licensed
hereunder, including without limitation any patents or
patent applications in any country of a Party covered by
the license grants under this Restated Agreement, are part
of the "intellectual property" as defined under Section
101(35A) of the Bankruptcy Code subject to the protections
afforded the non-terminating Party under Section 365(n) of
the Bankruptcy Code, and any similar law or regulation in
any other country.
12
9.4 POST TERMINATION RIGHTS/OBLIGATIONS. Notwithstanding the foregoing,
the following rights and obligations shall survive termination of
this Restated Agreement to the degree necessary to permit their
complete fulfillment or discharge:
9.4.1 IDT's right to receive or recover and ISIS's obligation to
pay licensing or sublicensing fees or royalties accrued or
accruable for payment at the time of any termination.
9.4.2 Licensee's obligation to maintain records and Licensor's
right to receive final year accounting reports as provided
in Section 3E.
9.4.3 Any cause of action or claim of Licensor, accrued or to
accrue because of any breach or default by the Licensee;
9.4.4 The rights and obligations of both parties regarding
confidentiality as defined in section 7 herein;
9.4.5 The warranty, indemnification and insurance provisions as
set forth in Section 6C, 6D, and 6E.
9.4.6 The rights of ISIS, its Affiliates or sublicensees within
[***] months following such date of termination, to sell or
dispose of IDT Licensed Commercial Products completed or
substantially completed on the date of termination and to
complete orders, outstanding on such date of termination
for such products.
9.4.7 The right of IDT or its Affiliates within [***] months
following such date of termination, to sell or dispose of
RNase H Oligonucleotides completed or substantially
completed on the date of termination and to complete
orders, outstanding on such date of termination for such
products.
9.5 SUCCESSOR IN INTEREST TO IDT. Should IDT, or its assigns, become
insolvent, bankrupt or subject to the provisions of the United
States Bankruptcy Code or any other similar legislation of any
jurisdiction, the right of the University of Iowa Research
Foundation to assume IDT's interest in the Xxxxxx Patents shall not
be abrogated in any way by any term or provision of this Agreement.
9.6 SURVIAL OF SUBLICENSES. Notwithstanding the termination of this
Restated Agreement or any of the licenses or sublicenses granted
hereunder, any sublicenses to the Xxxxxx Patents granted by ISIS or
its Affiliates pursuant to Article 3 hereof prior to the termination
of the Restated Agreement shall survive such termination. In such
event, ISIS shall have the right to exercise all of the rights of
IDT as the sublicensor under such sublicense, subject to its
compliance with continuing obligations regarding surviving
sublicenses as defined in section 9.4 herein.
13
ARTICLE 10
DISPUTE RESOLUTION
10.1 DISPUTES--ARBITRATION. The parties agree to attempt initially, to
solve all claims, disputes, or controversies arising under, out of,
or in connection with this Restated Agreement by conducting good
faith negotiations. Except with respect to disputes as to the
validity of patents, applications for injunctions, specific
performance, or other equitable relief, any dispute arising out of
or in connection with this Restated Agreement or any legal
relationship associated therewith, that cannot be resolved amicably
by the parties, shall be finally resolved by arbitration. The
arbitration shall be conducted in accordance with the arbitration
rules of the American Arbitration Association ("AAA") then in force,
by one or more arbitrators appointed in accordance with said rules;
provided, however, that arbitration proceedings may not be
instituted until the party alleging breach of this Restated
Agreement by the other party has given the other party not less than
sixty (60) days notice to remedy any alleged breach and the other
party has failed to do so. The place of arbitration shall be Cedar
Rapids, Iowa, if Isis institutes the proceeding, and San Diego,
California, if IDT institutes the proceeding. The award rendered
shall be final and binding upon both parties. The judgment rendered
shall include costs of arbitration, reasonable attorney's fees and
reasonable costs for any expert and other witnesses. The arbitration
may expressly consider the amounts paid pursuant to Sections 3B, 3C,
and 3D, in considering any claims of any damages. Judgment upon the
award may be entered in any court having jurisdiction, or
application may be made to such court for judicial acceptance of the
award and/or an order of enforcement. Disputes as to the validity
and scope of patents shall be resolved by the courts of appropriate
jurisdiction.
ARTICLE 11
MISCELLANEOUS
11.1 APPLICABLE LAW. This Restated Agreement shall be construed in
accordance with the internal laws of the State of New York. If any
provisions of this Agreement are or shall come into conflict with
the laws or regulations of any jurisdiction or any governmental
entity having jurisdiction over the parties or this Restated
Agreement, those provisions shall be deemed automatically deleted,
if such deletion is allowed by relevant law, and the remaining terms
and conditions of this Restated Agreement shall remain in full force
and effect. If such a deletion is not so allowed or if such a
deletion leaves terms thereby made clearly illogical or
inappropriate in effect, the parties agree to substitute new terms
as similar in effect to the present terms of this Restated Agreement
as may be allowed under the applicable laws and regulations. The
parties hereto are independent contractors and not joint ventures or
partners.
11.2 CONSTRUCTION/EFFECT. The parties acknowledge that this Restated
Agreement has been the subject of full opportunity for negotiation
and amendment and that the party who has taken the role of drafter
shall not suffer any adverse construction of any terms or language
of this Restated Agreement because of such role.
14
11.3 FORCE MAJEURE. A party hereto shall not be deemed in default with
respect to the performance of or compliance with the terms,
covenants, agreements conditions or provisos of this Agreement if
the failure to perform or comply shall be due to any event of force
majeure. "Force majeure" shall include natural disasters, acts of
God, or any other event or cause beyond the control of the party
claiming the benefit of this paragraph and which that party could
not reasonably have protected itself against, provided however that
lack of funds or credit shall not constitute an event of force
majeure.
11.4 ASSIGNABILITY. This Restated Agreement may not be transferred or
assigned by either party without the prior written consent of the
other party, except that either Party may freely assign this
Restated Agreement to (i) an Affiliate, if the assigning Party
guarantees the full performance of its Affiliates' obligations
hereunder, or (ii) an entity acquiring substantially all of
Licensee's business to which the License relates. Any purported
assignment in contravention of this section shall, at the option of
the non-assigning party, be null and void and of no effect.
11.5 NOTICES. Any notice required to be given pursuant to the provisions
of this Restated Agreement shall be in writing and shall be deemed
to have been given at the earlier of the time when actually received
as a consequence of any effective method of delivery, including but
not limited to hand delivery, transmission by facsimile, or delivery
by a professional courier service, or the time when sent by
certified or registered mail addressed to the party. Any notice of
change of address shall be effective only upon actual receipt, by
the persons listed below or other formally authorized person(s)
acting in their behalf.
With respect to IDT:
Xxxxxx X. Xxxxxx, M.D., Ph.D.
Attn: Legal Department
Integrated DNA Technologies, Inc.
0000 Xxxxxxxxxx Xxxx
Xxxxxxxxxx, XX 00000-0000;
With a duplicate sent to:
Xxxx Xxxxxxxx, X.X., COO
Corporate Vice President
Integrated DNA Technologies, Inc.
0000 Xxxxx Xxxxx Xxxx, Xxxxx 000
Xxxxxx, Xxxxxxxx, 00000
With respect to ISIS:
B. Xxxxx Xxxxxxxx, X.X.
Isis Pharmaceuticals, Inc.
Executive Vice President and CFO
15
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
With a duplicate sent to:
President of GeneTrove
Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
11.6 INTEGRATION. This Restated Agreement constitutes the full
understanding between the parties with reference to the subject
matter hereof, and no statements or agreements by or between the
parties, whether orally or in writing, made prior to or at the
signing hereof, shall vary or modify the written terms of this
Restated Agreement. Neither party shall claim any amendment,
modification, or release from any provisions of this Restated
Agreement by mutual agreement, acknowledgement, or otherwise, unless
such mutual agreement is in writing, signed by the other party, and
specifically states that it is an amendment to this Restated
Agreement.
11.7 BENEFITS. All terms and provisions of this Restated Agreement shall
bind and inure to the benefit of the parties hereto, and upon their
respective successors and assigns as those are permitted under the
terms of this Restated Agreement.
11.8 AUTHORITY. The persons signing on behalf of IDT and Isis hereby
warrant and represent that they have authority to execute this
Restated Agreement on behalf of the party for whom they have signed.
REMAINDER OF THIS PAGE LEFT INTENTIONALLY BLANK
SIGNATURE PAGE TO IMMEDIATELY FOLLOW
16
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement by their
duly authorized representatives.
ISIS PHARMACEUTICALS, INC. INTEGRATED DNA TECHNOLOGIES, INC.
By: Xxxxxxx. X. Xxxxx By: Xx. Xxxxxx X. Xxxxxx
Signature: /s/ Xxxxxxx. X. Xxxxx Signature: /s/ Xx. Xxxxxx X. Xxxxxx
-------------------------- ------------------------
Title: President, GeneTrove
Vice President, ISIS Pharmaceuticals Title: President & CEO
Date: 12/04/01 Date: 12/04/01
17
Restated Agreement
Appendix A
LICENSE FEE AND ROYALTY SCHEDULES FOR
ANTISENSE DRUG DEVELOPMENT SUBLICENSES
[***]
EXHIBIT 1
ISIS ACADEMIC PATENTS
[***]
18
