Exhibit 10.58
CROSS LICENSE
AGREEMENT
between
ELEOS, INC.
and
AVI BIOPHARMA,
INC.
CROSS LICENSE
AGREEMENT
THIS CROSS LICENSE
AGREEMENT (the
“Agreement”) is made and is effective as of the 8th day
of January, 2007 (the “Effective Date”) by and between
AVI BioPharma, Inc., an Oregon corporation with its principal place
of business at One SW Columbia, Suite 1105, Portland, Oregon 97258
(“AVI”), and Eleos, Inc., a Delaware corporation with
its principal place of business at One Valmont Plaza; Suite 301,
Omaha, Nebraska 68154 (“Eleos”) (with each of AVI and
Eleos referred to as a “Party” and jointly, the
“Parties”).
RECITALS
WHEREAS , each of the Parties owns, controls or
otherwise has rights with regard to its respective Intellectual
Property related to technologies and products for regulation of p53
protein, with Eleos controlling intellectual property related to
uses of antisense p53 sequences and specific antisense p53
sequences that have superior properties compared to other p53
target sequences, and with AVI owning intellectual property
relating to phosphorodiamidate morpholino oligomer
(“PMO”) chemistry and its uses expected to lead to
antisense drugs directed against p53 that have superior
pharmaceutical properties for some purposes compared with drugs
based on other antisense chemistries, identified as AVI
Intellectual Property on attached Exhibit A and Eleos
Intellectual Property on attached Exhibit B;
WHEREAS, Eleos and AVI wish to pursue their own
development and joint development opportunities resulting from the
combination of Eleos’ p53 technology and AVI’s PMO
technology;
WHEREAS , Eleos’ main field of interest in p53-PMO
technology is as a therapeutic target for the treatment of cancer,
including protection of non-malignant or normal cells and tissues
from the effects of chemotherapy and radiation, AVI’s main
field of interest in p53-PMO technology is as a potential target
for antiviral therapies, and the Parties wish to cooperate in the
development and commercialization of therapies using p53-PMO
technology in other fields;
WHEREAS , the Parties wish to obtain from each other and
make available to each other certain rights for the development and
clinical and commercial manufacture, use and sale of products using
the AVI Intellectual Property and Eleos Intellectual Property on
the terms and conditions set forth in this Agreement.
NOW THEREFORE
, the Parties agree as
follows:
1.
Definitions
All definitions below or elsewhere
in this Agreement apply to both their singular and plural forms, as
the context may require. “Herein,”
“hereunder,” and “hereof” and other similar
expressions refer to this Agreement. “Section”
refers to sections in this Agreement. “Including”
means “including without limitation.”
“Days” means “calendar days,” unless
otherwise stated.
1.1
“Affiliate” means any corporation or business entity
that directly or indirectly controls, is controlled by, or is under
common control with Eleos or AVI to the extent of at least 50
percent of the outstanding stock or other voting rights entitled to
elect directors.
1.2
“API” means the active pharmaceutical ingredient for a
Licensed Product.
1.3
“AVI Confidential Information” is Confidential
Information of AVI.
1.4
“AVI Field” means the treatment of all viral diseases
except for those related to human immunodeficiency virus (HIV)
infection.
1.5
“AVI Improvements” means any change, modification,
enhancement or addition which is an improvement to or further
development of the AVI Intellectual Property, whether or not
patentable or copyrightable and whether created by AVI or Eleos
acting alone or by AVI and Eleos acting jointly.
1.6
“AVI Intellectual Property” means the intellectual
property listed in Exhibit A and rights under any other
Intellectual Property of AVI developed or acquired by AVI
subsequent to execution of this Agreement which, absent the license
to Eleos hereunder, would be infringed by Eleos in the development
or commercialization of products in the Eleos Field.
1.7
“AVI Net Sales” means the total of the gross sales of
Licensed Eleos IP Products sold or transferred by AVI and
AVI’s Affiliates and sublicensees, less the following actual
and customary third-party wholesaler and or distributor deductions
as applicable: reasonable and customary wholesaler or distributor
sales commissions (for clarity, commissions and other compensation
paid to sales and marketing personnel of AVI or its marketing
partner(s) are not deductible); allowances or credits to purchasers
for rejections, returns, withdrawals or recalls; cash, trade or
quantity discounts; sales rebates or chargebacks; third party
distribution fees; sales, use, excise or other taxes imposed on
sales; import and export duties; and shipping charges. To the
extent AVI has deducted amounts as permitted by the preceding
sentence and AVI later receives a refund against the amount
deducted, the refunded amount shall be included as part of AVI Net
Sales. Payments shall be made only upon sales or transfers
between unrelated third parties and shall be based on arms-length
consideration. In the event AVI or any of its Affiliates
makes a transfer of a Licensed Eleos IP Product to a third party
for other than monetary consideration or for less than fair market
value, such transfer shall be considered a sale hereunder to be
calculated at a fair market value for accounting and royalty
purposes. A Licensed Eleos IP Product shall be deemed sold or
transferred at the time the entity making the transaction on which
the royalty is based bills, invoices, ships, or receives payment
for such Licensed Eleos IP Product, whichever occurs first.
For sales of a Licensed Eleos IP Product which constitutes a
Combination Product, AVI Net Sales will be calculated based on a
reasonable allocation between the Combination Product Components
and the remainder of the Licensed Eleos IP Product.
1.8
“Combination Product” means a combined product that
contains or uses a Licensed Product and at least one other
therapeutic product (a “Combination Product
Component”), where such Combination Product Component is not
a Licensed Product; such Combination Product Component and such
Licensed Product are usually sold separately; and the market price
of such combined product is higher than the market price for such
Licensed Product (if sold separately) as a result of such combined
product containing or using such Combination Product
Component.
1.9
“Confidential Information” means any commercially
sensitive information of a Party in its broadest context, whether
in writing (including any computer files or records), oral form or
available by observation, not generally known to the public, and
includes all (i) matters of a technical nature such as trade secret
processes or devices, techniques, data, formulas, inventions
(whether or not patentable), specifications and characteristics of
products planned or being developed, research subjects, methods and
results, regulatory strategies, and patent prosecution documents
with regard to a Party’s Intellectual Property; (ii) matters
of a business nature such as information about costs, margins,
pricing policies, markets, sales, suppliers, customers, product
plans, marketing plans or strategies and any other financial
information; and (iii) the specific terms of this Agreement and any
Statement of Work.
1.10
“Effective Date” means the date first written
above.
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1.11
“Eleos Confidential Information” is Confidential
Information of Eleos.
1.12
“Eleos Field” means the treatment of cancer, including
the protection of non-malignant or normal cells and tissues from
the effects of chemotherapy and radiation.
1.13
“Eleos Improvements” means any change, modification,
enhancement or addition which is an improvement to or further
development of the Eleos Intellectual Property, whether or not
patentable or copyrightable and whether created by AVI or Eleos
acting alone or by AVI and Eleos acting jointly.
1.14
“Eleos Intellectual Property” means the Intellectual
Property listed in Exhibit B, and rights under any other
Intellectual Property of Eleos developed or acquired by Eleos
subsequent to execution of this Agreement which, absent the license
to AVI hereunder, would be infringed by AVI in the development or
commercialization of products in the AVI Field.
1.15
“Eleos Net Sales” means the total of all sales of
Licensed AVI IP Products sold or transferred by Eleos and
Eleos’ Affiliates and sublicensees, less the following actual
and customary third-party wholesaler and distributor deductions as
applicable: reasonable and customary wholesaler or distributor
sales commissions (for clarity, commissions and other compensation
paid to sales and marketing personnel of Eleos or its marketing
partner(s) are not deductible); allowances or credits to purchasers
for rejections, returns, withdrawals or recalls; cash, trade or
quantity discounts; sales rebates or chargebacks; third party
distribution fees; sales, use, excise or other taxes imposed on
sales; import and export duties; and shipping charges. To the
extent Eleos has deducted amounts as permitted by the preceding
sentence and Eleos later receives a refund against the amount
deducted, the refunded amount shall be included as part of Eleos
Net Sales. Payments shall be made only upon sales or
transfers between unrelated third parties and shall be based on
arms-length consideration. In the event Eleos or any of its
Affiliates makes a transfer of a Licensed AVI IP Product to a third
party for other than monetary consideration or for less than fair
market value, such transfer shall be considered a sale hereunder to
be calculated at a fair market value for accounting and royalty
purposes. A Licensed AVI IP Product shall be deemed sold or
transferred at the time the entity making the transaction on which
the royalty is based bills, invoices, ships, or receives payment
for such Licensed AVI IP Product, whichever occurs first. For
sales of a Licensed AVI IP Product which constitutes a Combination
Product, Eleos Net Sales will be calculated based on a reasonable
allocation between the Combination Product Components and the
remainder of the Licensed AVI IP Product.
1.16
“FDA” means the United States Food and Drug
Administration.
1.17
“Intellectual Property” means patents, patent
applications, utility models, industrial designs, certificates of
inventions, trademarks, copyrights, trade secrets, know how, and
any other Intellectual Property rights in any country of the world,
including all related filings, substitutions, extensions, reissues,
renewals, continuations and continuations in part, all
registrations and the like.
1.18
“Joint Development Proposal” has the meaning set forth
in Section 7.2.
1.19
“Joint Field” means the treatment of all diseases and
conditions outside the AVI Field and the Eleos Field
1.20
“Jointly Owned Intellectual Property” means Newly
Created Intellectual Property that is owned by both parties in
accordance with the terms of this Agreement.
1.21
“Joint p53-PMO Item” means any material, product,
service, process, or procedure, which combines Eleos Intellectual
Property related to p53 and AVI Intellectual Property related to
PMO,
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whether such
Intellectual Property exists as of the Effective Date or is
developed or acquired subsequent to execution of this Agreement,
for treatment of diseases with currently existing or novel
morpholino compounds that target the p53 gene, or p53 RNA or
intentionally target proteins encoded by the p53 gene in order to
achieve a therapeutic effect.
1.22
“Licensed AVI IP Method” means any process, method, or
use that is covered by AVI Intellectual Property or the use or
practice of which would constitute, but for the license granted to
Eleos pursuant to this Agreement, an infringement of the AVI
Intellectual Property.
1.23
“Licensed AVI IP Product” means any material, product,
service, process, or procedure that (i) is covered by AVI
Intellectual Property or whose discovery, development,
registration, manufacture, use, or sale would constitute, but for
the license granted to Eleos pursuant to this Agreement, an
infringement of any claim within the AVI Intellectual Property or
(ii) is discovered, developed, made, sold, registered, or
practiced using AVI Intellectual Property or a Licensed AVI IP
Method or (iii) is used to practice the Licensed AVI IP
Method, in whole or in part.
1.24
“Licensed Eleos IP Method” means any process, method,
or use that is covered by Eleos Intellectual Property or the use or
practice of which would constitute, but for the license granted to
AVI pursuant to this Agreement, an infringement of the Eleos
Intellectual Property.
1.25
“Licensed Eleos IP Product” means any material,
product, service, process, or procedure that (i) is covered by
Eleos Intellectual Property or whose discovery, development,
registration, manufacture, use, or sale would constitute, but for
the license granted to AVI pursuant to this Agreement, an
infringement of any claim within the Eleos Intellectual Property or
(ii) is discovered, developed, made, sold, registered, or
practiced using Eleos Intellectual Property or a Licensed Eleos IP
Method or (iii) is used to practice the Licensed Eleos IP
Method, in whole or in part.
1.26
“Licensed Product” means a Licensed AVI IP Product or
Licensed Eleos IP Product, as applicable according to the
context.
1.27
“Net Sales” means AVI Net Sales or Eleos Net Sales, as
applicable according to the context.
1.28
“Newly Created Intellectual Property” means
Intellectual Property created during the term of this Agreement by
one or both of the Parties hereto and in furtherance of performance
under this Agreement.
1.29
“Statement of Work” has the meaning set forth in
Section 7.1.
1.30
“Sublicensing Income” means amounts received by a Party
and its successors, assigns and Affiliates from unaffiliated third
parties attributable to a sublicense of rights licensed under this
Agreement.
1.31
“Third Party Licensors” means *****, *****, *****, and
any other unrelated third-party patent licensor to which Eleos or
AVI pays patent licensing fees or royalties to make, use or sell a
Licensed Product. “Unrelated third-party patent
licensor” refers to entities having no relationship to Eleos
or AVI other than to claim patent royalties and expressly excludes
developers, suppliers, contractors, employees and consultants
engaged by Eleos or AVI.
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2.
License
Grants .
2.1
By AVI to Eleos .
(a)
Exclusive . Subject to the limitations set forth in
this Agreement, AVI hereby grants to Eleos and its Affiliates, so
long as they remain Affiliates of Eleos, an exclusive, worldwide
license, with the right to sublicense (subject to Section 3 below),
to AVI Intellectual Property that relates to a Joint p53-PMO Item,
solely in the Eleos Field, to research, develop, make, have made,
subject to the terms of Article 9, use, import, put into use,
modify, distribute, offer for sale, sell and have sold Licensed AVI
IP Products and to practice Licensed AVI IP Methods during the term
of this Agreement. As used in this Section 2.1,
“exclusive” means that AVI may not grant to any third
party a license of the AVI Intellectual Property, in whole or in
part, within the Eleos Field and may not itself practice the AVI
Intellectual Property within the Eleos Field.
(b)
Semi-Exclusive . Effective as of the effective date of
any Statement(s) of Work executed by the Parties under which the
Parties agree to engage in joint development activities, and
subject to the specific terms and conditions of such Statement(s)
of Work, AVI shall grant to Eleos and its Affiliates, so long as
they remain Affiliates of Eleos, a semi-exclusive, worldwide
license to AVI Intellectual Property that relates to a Joint
p53-PMO Item, solely in the Joint Field and within the context of
such joint development activities with AVI, to research, develop,
make, have made, subject to the terms of Article 9, use, import,
put into use, modify, distribute, offer for sale, sell and have
sold Licensed AVI IP Products and to practice Licensed AVI IP
Methods during the term of this Agreement. Nothing herein
will limit the right of AVI or its Affiliates to practice any claim
encompassed within the foregoing within the Joint
Field.
2.2
By Eleos to AVI .
(a)
Exclusive . Subject to the limitations set forth in
this Agreement, Eleos hereby grants to AVI and its Affiliates, so
long as they remain Affiliates of AVI, an exclusive, worldwide
license (or sublicense as the case may be), with the right to
sublicense (subject to Section 3 below), to Eleos Intellectual
Property that relates to a Joint p53-PMO Item, solely in the AVI
Field, to research, develop, make, have made, use, import, put into
use, modify, distribute, offer for sale, sell and have sold
Licensed Eleos IP Products and to practice Licensed Eleos IP
Methods during the term of this Agreement. As used in this
Section 2.2, “exclusive” means that Eleos may not
grant to any third party a license of the Eleos Intellectual
Property, in whole or in part, within the AVI Field and may not
itself practice the Eleos Intellectual Property within the AVI
Field.
(b)
Semi-Exclusive . Effective as of the effective date of
any Statement(s) of Work executed by the Parties under which the
Parties agree to engage in joint development activities, and
subject to the specific terms and conditions of such Statement(s)
of Work, Eleos shall grant to AVI and its Affiliates, so long as
they remain Affiliates of AVI, a semi-exclusive, worldwide license
to Eleos Intellectual Property that relates to a Joint p53-PMO
Item, solely in the Joint Field and within the context of such
joint development activities with Eleos, to research, develop,
make, have made, use, import, put into use, modify, distribute,
offer for sale, sell and have sold Licensed Eleos IP Products and
to practice Licensed Eleos IP Methods during the term of this
Agreement. Nothing herein will limit the right of Eleos or
its Affiliates to practice any claim encompassed within the
foregoing within the Joint Field.
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2.3
Improvements . Each Party will promptly advise the
other of AVI Improvements or Eleos Improvements made by it and its
Affiliates during the term of this Agreement, to the extent
lawfully able to be disclosed. AVI Improvements will
automatically be included within the definition of “AVI
Intellectual Property,” and Eleos Improvements will
automatically be included within the definition of “Eleos
Intellectual Property,” subject to the terms contained
herein.
2.4
c-myc Conflicts with AVI Intellectual Property . If in
the future a patent is granted to Eleos or an Affiliate of Eleos
related to c-myc, the claims of which would cause an AVI product
actually or potentially to infringe such claims, Eleos will grant
to AVI a non-exclusive license to such claims in so far as they
apply to the infringing or potentially infringing AVI product at
nominal cost to AVI, e.g. , $1.00 plus reimbursement of
Eleos’ legal costs to finalize the license agreement, and no
other cost. If in the future Eleos or an Affiliate of Eleos
gains rights via a license agreement to patents related to c-myc,
the claims of which would cause an AVI product actually or
potentially to infringe such claims, Eleos will grant to AVI a
non-exclusive sublicense to such claims in so far as they apply to
the infringing or potentially infringing AVI product at nominal
cost to AVI, e.g. , $1.00 plus reimbursement of Eleos’
legal costs to finalize the sublicense agreement, and no other
cost. If Eleos has a royalty obligation to such third
party licensor for such c-myc patent claims, the sublicense to AVI
will include the same royalty obligation as a pass-through without
any mark up.
3.
Sublicenses
3.1
Sublicenses Granted By Eleos .
(a)
AVI grants to Eleos the right to grant sublicenses to third parties
under the licenses granted in Section 2.1, provided that
(i) Eleos has current exclusive rights to the AVI Intellectual
Property that relates to a Joint p53-PMO Item in the relevant field
under this Agreement at the time it exercises a right of
sublicense, (ii) Eleos obtains the written consent of AVI, and
(iii) the sublicense results from a written agreement entered
into by Eleos and the sublicensee. Within fourteen (14) days
after execution of any sublicense agreement, Eleos shall provide
AVI with a copy of such agreement, and shall thereafter summarize
and deliver all reports due to AVI relating to the
sublicensees. If Eleos is in material compliance with its
duties under this Agreement, AVI shall not contact any such
sublicensee.
3.2
Sublicenses Granted By AVI .
(a)
Eleos grants to AVI the right to grant sublicenses to third parties
under the licenses (or sublicenses as the case may be) granted in
Section 2.2, provided that (i) AVI has current exclusive
rights to the Eleos Intellectual Property that relates to a Joint
p53-PMO Item in the relevant field under this Agreement at the time
it exercises a right of sublicense, (ii) AVI obtains the
written consent of Eleos, and (iii) the sublicense results
from a written agreement entered into by AVI and the
sublicensee. Within fourteen (14) days after execution of any
sublicense agreement, AVI shall provide Eleos with a copy of such
agreement, and shall thereafter summarize and deliver all reports
due to Eleos relating to the sublicensees. If AVI is in
material compliance with its duties under this Agreement, Eleos
shall not contact any such sublicensee.
4.
License Fees
and Royalties .
4.1
Initial License Fee . Within three (3) business days
of the Effective Date, Eleos will pay AVI Five Hundred Thousand
Dollars ($500,000.00) according to wire transfer instructions
provided by AVI.
6
4.2
Eleos Milestone Payments . Eleos shall make the
following one-time payments to AVI upon achieving the milestones
set forth below with regard to a Licensed AVI IP
Product:
|
Milestone
|
|
|
|
Payment Amount
|
|
|
Enrollment of the first patient in
the first human clinical study
|
|
$
|
*****
|
|
|
Enrollment of the first patient in a
Phase III or pivotal study
|
|
$
|
*****
|
|
|
The first filing of a New Drug
Application
|
|
$
|
*****
|
|
|
The first commencement of commercial
sales after FDA approval of New Drug Application
|
|
$
|
*****
|
|
|
The first time Eleos achieves $*****
in cumulative Eleos Net Sales
|
|
$
|
*****
|
|
|
The first time Eleos achieves
$***** in cumulative Eleos Net Sales
|
|
$
|
*****
|
|
As a clarifying example with respect to Sections 4.2 and 4.4, if a
Party achieves the first filing of a New Drug Application for more
than one Licensed Product, the ***** payment amount by that Party
will only be payable the first time that that milestone is achieved
and no payment will be due for the subsequent times that that
milestone is achieved.
Eleos shall pay all milestone
payments hereunder within thirty (30) days following the date on
which the milestone is achieved.
4.3
Earned Royalties - Eleos .
(a) Eleos
will pay AVI earned royalties of *****% of Eleos Net Sales received
with regard to Licensed AVI IP Products which are not manufactured
by AVI, less any royalty payments payable to Third Party Licensors,
provided that in no instance shall the royalty payable under this
Section 4.3(a) to AVI after reduction for payments to the Third
Party Licensors equal less than *****% of Eleos Net
Sales.
(b) Eleos
will pay AVI earned royalties of *****% of Eleos Net Sales received
with regard to Licensed AVI IP Products which are manufactured by
AVI, less any royalty payments payable to Third Party Licensors,
provided that in no instance shall the royalty payable under this
Section 4.3(b) to AVI after reduction for payments to the Third
Party Licensors equal less than *****% of Eleos Net
Sales.
(c) In the
event that royalties cease to be payable to any Third Party
Licensor, the royalties payable by Eleos to AVI under this Section
4.3 will be adjusted such that Eleos and AVI share equally in the
financial benefit of the expiration or termination of the
obligation to pay such royalties to the Third Party
Licensor.
4.4
AVI Milestone Payments . AVI shall make the following
one-time payments to Eleos upon achieving the milestones set forth
below with regard to a Licensed Eleos IP Product:
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|
Milestone
|
|
|
|
Payment Amount
|
|
|
Enrollment of the first patient in
the first human clinical study
|
|
$
|
*****
|
|
|
Enrollment of the first patient in a
Phase III or pivotal study
|
|
$
|
*****
|
|
|
The first filing of a New Drug
Application
|
|
$
|
*****
|
|
|
The first commencement of commercial
sales after FDA approval of a New Drug Application
|
|
$
|
*****
|
|
|
The first time AVI achieves $*****
in cumulative AVI Net Sales
|
|
$
|
*****
|
|
|
The first time AVI achieves $*****
in cumulative AVI Net Sales
|
|
$
|
*****
|
|
AVI shall pay all milestone payments hereunder within thirty (30)
days following the date on which the milestone is
achieved.
4.5
Earned Royalties - AVI .
(a)
AVI will pay Eleos earned royalties of *****% of AVI Net Sales,
less any royalty payments payable to Third Party Licensors,
provided that in no instance shall the royalty payable under this
Section 4.5(a) to Eleos after reduction for payments to Third Party
Licensors equal less than *****% of AVI Net Sales.
(b) In
the event that royalties cease to be payable to any Third Party
Licensor, the royalties payable by AVI to AVI under this Section
4.5 will be adjusted such that AVI and AVI share equally in the
financial benefit of the expiration or termination of the
obligation to pay such royalties to the Party Licensor.
4.6
Timing of Royalty Payments, Currency, Taxes and Fees
.
(a)
Royalties payable to AVI or Eleos shall be paid quarterly on or
before sixty (60) days following the end of each calendar quarter:
March 31, June 30, September 30 and
December 31. Each such payment will be for unpaid
royalties that accrued within or prior to the most recently
completed calendar quarter. For example, within 60 days after
March 31, each Party shall pay royalties for the calendar
quarter ending March 31 and any unpaid royalties accrued prior
to such calendar quarter.
(b)
All amounts due under this Agreement shall be payable in United
States dollars. When Licensed Eleos IP Products or Licensed
AVI IP Products are sold for currency other than United States
dollars, the earned royalties will first be determined in the
foreign currency of the country in which such products were sold
and then converted into equivalent United States dollars. The
exchange rate will be the United States dollar buying rate quoted
in the Wall Street Journal on the last day of the reporting
period.
(c)
The Party paying royalties hereunder shall be responsible for all
taxes, fees or other charges imposed by the government of any
country outside the United States on
8
the remittance of royalty income for
sales occurring in any such country and for all bank transfer
charges on such payments.
(d) If
at any time legal restrictions prevent the acquisition or prompt
remittance of United States dollars by a Party owing royalties
hereunder with respect to any country where a Licensed Eleos IP
Product or Licensed AVI IP Product is sold, the Party owing such
royalties shall make payment from its other sources of United
States dollars.
4.7
Expiration or Invalidity of Patent . In the event that
(i) any patent or any claim thereof included within the AVI
Intellectual Property or Eleos Intellectual Property shall be held
invalid in a final decision by a court of competent jurisdiction
and last resort in any country from which no appeal has or can be
taken or (ii) if the local patent authority within such
country determines that no patent may issue in a final decision
from which no appeal has or can be taken, and hence there is no
valid patent claim within the relevant Intellectual Property in
such country, all obligation to pay royalties based on such patent
or claim shall cease as of the date of such final decision with
respect to such country. The Party liable for royalties in
such a case shall not, however, be relieved from paying any
royalties that accrued before such decision or that are based on
another patent or claim not involved in such decision, or that are
based on non-patent Intellectual Property of the other
Party.
5.
Diligence
.
5.1
By Eleos .
(a)
Eleos, commencing upon the Effective Date, shall use commercially
reasonable efforts to develop, test, obtain any required
governmental approvals, manufacture, market and sell Licensed AVI
IP Products.
(b)
Within one year after the Effective Date, Eleos shall prepare and
provide to AVI a formal commercially reasonable market analysis and
development plan (hereinafter the “Eleos Plan”).
Eleos shall follow the timelines set forth in the Eleos Plan in
terms of products to be commercialized within the timelines
outlined in the Eleos Plan. Recognizing the uncertainties
that will be inherent in the Eleos Plan, Eleos shall have the right
to amend the Eleos Plan with the consent with AVI, such consent not
to be unreasonably withheld.
(c)
Within three months of receiving all required government approvals
necessary for marketing a Licensed AVI IP Product in any country,
such as marketing authorization and government pricing and
reimbursement approvals, Eleos shall commence commercial marketing
of such product in such country; and shall thereafter use
commercially reasonable efforts to meet the market demand for such
products in such country at all times during the exclusive period
of this Agreement.
(d) If
Eleos materially fails to perform any of its obligations under this
Section 5 in a timely manner, except by reason of force
majeure, then AVI shall have the right to terminate this Agreement
in accordance with Section 13.
5.2
By AVI .
(a) AVI,
commencing upon the Effective Date, shall use commercially
reasonable efforts to develop, test, obtain any required
governmental approvals, manufacture, market and sell Licensed Eleos
IP Products.
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(b) Within
one year after the Effective Date, AVI shall prepare and provide to
Eleos a formal commercially reasonable market analysis and
development plan (hereinafter the “AVI Plan”).
AVI shall follow the timelines set forth in the AVI Plan in terms
of products to be commercialized within the timelines outlined in
the AVI Plan. Recognizing the uncertainties that will be
inherent in the AVI Plan, AVI shall have the right to amend the AVI
Plan with the consent of Eleos, such consent not to be unreasonably
withheld.
(c) Within
three months of receiving all required government approvals
necessary for marketing a Licensed Eleos IP Product in any country,
such as marketing authorization and government pricing and
reimbursement approvals, AVI shall commence commercial marketing of
such product in such country; and shall thereafter use commercially
reasonable efforts to meet the market demand for such products in
such country at all times during the exclusive period of this
Agreement.
(d) If AVI
materially fails to perform any of its obligations under this
Section 5 in a timely manner, except by reason of force
majeure, then Eleos shall have the right to terminate this
Agreement in accordance with Section 13.
6.
Progress and
Royalty Reports .
6.1
Progress Reports . At the end of the first full
calendar half-year after the Effective Date, and semi-annually
thereafter, each Party shall submit to the other Party a progress
report covering its activities related to the development and
testing of Licensed AVI IP Products or Licensed Eleos IP Products,
as the case may be, and the obtaining of the U.S. and foreign
governmental approvals necessary for their marketing. These
progress reports shall be made for each such product in
development.
6.2
Contents . The progress reports submitted under
Section 6.1 shall include sufficient information to enable the
other Party to determine the submitting Party’s progress in
fulfilling its obligations under Section 5, including, but not
limited to, the following topics:
(a) summary
of work completed;
(b) summary
of work in progress, including product development and testing and
progress in obtaining government approvals;
(c) schedule
of anticipated events or milestones;
(d) market
plans for introduction of Licensed Products in each region (U.S.,
EU, Japan) where such products have not been introduced;
and
(e)
activities in obtaining sublicensees and activities of
sublicensees.
6.3
Meetings . On or about each anniversary of the
Effective Date, each Party shall have the right to call for a
half-day, detailed review meeting during which the Parties and
representatives of their sublicensees, to the extent required under
the Parties’ sublicense agreements, shall discuss the
progress reports submitted under Section 6.1. These
meetings shall be held under appropriate conditions of
confidentiality, and each Party will cause its scientists and other
staff to provide full and detailed information to enable the other
Party to evaluate the progress reports submitted under this Section
6 and to evaluate proposed amendments to the Eleos Plan and AVI
Plan as described in Section 5.
10
6.4
Report of First Sales . Each Party shall report to the
other Party in its immediately subsequent progress and royalty
report the date of first commercial sales of each Licensed Product
in each country.
6.5
Royalty Reports . After the first sale of each
Licensed Product anywhere in the world, the selling Party will make
quarterly royalty reports to the other Party on or before sixty
(60) days after March 31, June 30, September 30 and
December 31 of each year. Each such royalty report will
cover the reporting Party’s most recently completed calendar
quarter and will show (a) the units sold, gross sales,
deductions listed by type and Net Sales of each type of Licensed
Product sold by the reporting Party and its Affiliates on which
royalties have not been paid, country by country; (b) the
amount of royalties and fees and other consideration, in U.S.
dollars, payable hereunder; (c) any other factor used to
calculate the royalty or any amount due hereunder; (d) the
currency exchange rates used, if any; and (e) any other
information relating to the foregoing reasonably requested by the
Party receiving the report.
6.6
Disclosure of Improvements . If and to the extent that
a Party makes any AVI Improvements or Eleos Improvements or becomes
aware of technical developments that would be relevant to the other
Party during the term of this Agreement, it shall promptly disclose
and report the same to the other Party, as provided in Section 2.3
above, so that the Licensed Products may be designed, manufactured
and sold with the latest and most effective technology
available.
7.
Product
Development .
7.1
In the Eleos Field . AVI, from time to time during the
term of this Agreement as requested by Eleos, agrees to use its
commercially reasonable efforts to provide development services to
Eleos in the Eleos Field. Examples of such services may
include manufacturing p53-targeted PMOs for preclinical and
clinical evaluation and conducting pilot toxicology and
pharmacokinetic studies. All such development activities
under this Section 7.1 shall be in accordance with the terms and
conditions contained in statements of work (a “Statement of
Work”) executed by the Parties in accordance with Section
7.3. The Parties expect that Eleos will compensate AVI for
its services under this Section 7.1 on a monthly basis in amounts
equal to AVI’s fully-burdened costs in providing such
services, as further provided in the applicable Statements of
Work. AVI will define “fully-burdened costs” and
provide full detail of this cost structure in the Statement of
Work.
7.2
In the Joint Field .
(a) If
a Party (the “Proposing Party”) wishes to pursue an
opportunity to develop and commercialize AVI Intellectual Property,
Eleos Intellectual Property and/or products embodying such
Intellectual Property in the Joint Field, it shall prepa
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