*** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT (INDICATED BY ASTERISKS) HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT UNDER 17 C.F.R. SECTIONS 200.80(B)(4) AND
240.24B-2.
EXHIBIT 10.34
JOINT DEVELOPMENT AND LICENSE AGREEMENT
BY AND BETWEEN
LG LIFE SCIENCES, LTD.
AND
ANADYS PHARMACEUTICALS, INC.
April 18, 2004
TABLE OF CONTENTS
ARTICLE 1
Definitions..................................................................... 1
ARTICLE 2
Joint Development Program....................................................... 8
2.1 General.......................................................... 8
2.2 Joint Development Committee...................................... 8
2.3 Global Development Plan.......................................... 10
2.4 Conduct of the Joint Development Program......................... 10
2.5 Global Development Costs and Budget.............................. 12
2.6 Discontinued Development......................................... 13
ARTICLE 3
Licenses........................................................................ 14
3.1 Scope............................................................ 14
3.2 Sublicenses...................................................... 15
3.3 Retained Rights.................................................. 15
ARTICLE 4
Regulatory Matters.............................................................. 15
4.1 Lead Regulatory Parties.......................................... 15
4.2 Ownership of Regulatory Approvals................................ 16
4.3 Regulatory Coordination.......................................... 16
ARTICLE 5
Commercialization Program....................................................... 18
5.1 Commercialization Rights......................................... 18
5.2 Milestone Payments............................................... 18
5.3 Royalties........................................................ 19
5.4 Commercial Supply................................................ 21
5.5 Commercialization of Program Products............................ 21
5.6 Joint Steering Committee......................................... 21
ARTICLE 6
Intellectual Property Protection and Related Matters............................ 22
6.1 Prosecution of Applications and Maintenance Administration....... 22
6.2 Enforcement...................................................... 24
6.3 Defense.......................................................... 25
6.4 Cooperation...................................................... 25
6.5 Marks for Program Products....................................... 25
ARTICLE 7
Representations, Warranties and Covenants....................................... 26
7.1 Corporate Power.................................................. 26
7.2 Due Authorization................................................ 26
7.3 Binding Agreement................................................ 26
7.4 No Conflict...................................................... 26
7.5 Ownership of Patent Rights....................................... 26
7.6 Patent Proceedings............................................... 26
7.7 Disclaimer of Warranties......................................... 26
7.8 Limitation of Liability.......................................... 26
i
ARTICLE 8
Indemnification................................................................. 27
8.1 Indemnification By Anadys........................................ 27
8.2 Indemnification By LGLS.......................................... 27
ARTICLE 9
Confidentiality................................................................. 28
9.1 General Rule..................................................... 28
9.2 Exclusions....................................................... 28
9.3 Survival......................................................... 28
9.4 Governmental Filings............................................. 28
9.5 Publications; Public Announcements............................... 29
9.6 Replacement of Prior Agreement................................... 29
ARTICLE 10
Term: Termination............................................................... 29
10.1 Term............................................................. 29
10.2 Termination...................................................... 29
ARTICLE 11
Miscellaneous................................................................... 31
11.1 Assignment....................................................... 31
11.2 Severability..................................................... 31
11.3 Notices.......................................................... 32
11.4 Governing Law.................................................... 32
11.5 Entire Agreement; Amendment...................................... 32
11.6 Headings; References............................................. 32
11.7 Independent Contractors.......................................... 32
11.8 Waiver........................................................... 33
11.9 Compliance with Export Regulations............................... 33
11.10 Counterparts..................................................... 33
11.11 Force Majeure.................................................... 33
11.12 No Strict Construction........................................... 33
11.13 No Third Party Beneficiaries..................................... 33
EXHIBITS DESCRIPTION
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Exhibit A LGLS Patent Rights
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ii
JOINT DEVELOPMENT AND LICENSE AGREEMENT
This Joint Development and License Agreement (the "Agreement"), dated the 18th
day of April, 2004 (the "Effective Date"), is by and between LG Life Sciences,
Ltd., a corporation organized and existing under the laws of the Republic of
Korea ("LGLS"), and Anadys Pharmaceuticals Inc., a corporation organized and
existing under the laws of the State of Delaware, United States ("Anadys").
RECITALS
WHEREAS, LGLS and Anadys are each in the business of discovering, developing and
commercializing pharmaceutical products;
WHEREAS, pursuant to that certain Amended and Restated Exclusive Option
Agreement, entered into as of February 24, 2004 with an effective date of
February 17, 2004 and as amended on March 22, 2004 (the "Option Agreement"),
between LGLS and Anadys, LGLS granted Anadys an option (the "Option") to enter
into a definitive agreement whereby, among other things, (1) LGLS and Anadys
would enter into a co-development program (as defined herein, the "Joint
Development Program") focused on the global clinical development and
registration of the compound known as LB80380 for treating chronic Hepatitis B
Virus (defined herein as "HBV") infection in humans and (2) LGLS would grant to
Anadys the exclusive right to develop, register and commercialize in the Anadys
Territory (as defined herein) said compound for so treating chronic HBV
infection in humans;
WHEREAS, Anadys has advised LGLS that it has exercised the Option; and
WHEREAS, LGLS and Anadys desire to enter into this Agreement in accordance with
the exercise by Anadys of the Option;
NOW, THEREFORE, in consideration of the mutual covenants and promises
hereinafter set forth, the sufficiency of which is hereby acknowledged, the
parties hereto hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 When used in this Agreement, each of the following terms shall have the
meanings set forth in this Article I:
"AFFILIATE" means any corporation or other entity which controls, is controlled
by, or is under common control with, a party. A corporation or other entity
shall be regarded as in control of another corporation or entity if it owns or
directly or indirectly controls more than 50% of the voting securities or other
ownership interest of the other corporation or entity, or if it possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of the corporation or other entity.
"ANADYS INVENTIONS" means Inventions conceived of and reduced to practice in the
course of the Joint Development Program solely by employees and agents of
Anadys.
"ANADYS TERRITORY" means all countries in the world except the LGLS Territory.
"ANNUAL PLAN" means that part of the Global Development Plan for any Contract
Year, to be updated as necessary and as agreed to by the parties hereto in
accordance with the provisions of this Agreement during such Contract Year.
"ANTI-HBV FIELD" means the field of treating chronic Hepatitis B Virus ("HBV")
infection in humans.
"[...***...] STUDY" means the [...***...] Study that is the subject of that
certain document entitled "The [...***...] Clinical Study".
***Confidential Treatment Requested
1
"BUSINESS DAY" means a day on which banking institutions in Seoul, Korea and San
Diego, California are open for business.
"CHINA" means The Peoples Republic of China.
"CLINICAL SUPPLY COSTS" means the fully burdened cost of the Compounds and
Program Products utilized in the clinical trials in furtherance of the Joint
Development Program.
"COMMERCIALIZATION" OR "COMMERCIALIZE" means any and all activities directed to
marketing, promoting, distributing, offering for sale and selling a product,
importing a product for sale, and manufacturing for commercial sale. When used
as a verb, "Commercialize" means to engage in Commercialization.
"COMPOUNDS" means (i) the compound designated LB80380, which has the following
structure:
[...***...];
(ii) [...***...], which has the following structure:,
;
[...***...]
(iii)[...***...], which has the following structure,
[...***...]
(iv) [...***...];
(v) [...***...]; and
(vi) [...***...].
"CONFIDENTIAL INFORMATION" means all proprietary materials, know-how or other
information (whether or not patentable) related to: (1) the Compounds and the
Program Products, (2) the Global Development Plan and Joint Development Program,
(3) the contents of this Agreement (including the exhibit attached hereto), the
Option Agreement (including the exhibit attached thereto), and the terms and
conditions of the transactions contemplated hereby and thereby and (4) such
other information of a confidential and proprietary nature disclosed by one
party to the other party during the term of this Agreement.
"CONTRACT QUARTER" means each full or partial calendar quarter during the Joint
Development Program Term.
***Confidential Treatment Requested
2
"CONTRACT YEAR" means (a) with respect to the first Contract Year, the period
beginning on the Effective Date and ending on December 31, 2004 (the "First
Contract Year"), and (b) with respect to each subsequent Contract Year, the
twelve (12) month period beginning on the day following the end of the First
Contract Year and each succeeding twelve (12) month period thereafter during the
Term (except that the last Contract Year shall end on the last day of the Joint
Development Program Term).
"CONTROL" means in relation to intellectual property rights possession of the
ability to grant a license or sublicense under such intellectual property rights
as provided for herein without violating the terms of any agreement or other
arrangement with any Third Party. For the removal of doubt, the capitalized term
"Control" as used in this Agreement is different from the uncapitalized term
"control" as used in the definition of Affiliate in this Section 1.1.
"COVERING", "COVER", or "COVERED" means, with respect to a Patent Right, that,
but for a license granted to a party under a Valid Claim included in such Patent
Right, the practice by such party of an invention claimed in such Patent Right
would infringe such Valid Claim or in the case of a Patent Right that is a
patent application, would infringe a Valid Claim in such patent application if
it were to issue as a patent.
"CRO" means a contract research organization engaged by LGLS or Anadys to manage
clinical or pre-clinical studies of or other Development activities relating to
any Compound or Program Product.
"DEVELOPMENT" or "DEVELOP" means, with respect to a drug candidate preclinical
and clinical drug development activities, including, among other things: test
method development and stability testing, toxicology, formulation, process
development, manufacturing scale-up, development-stage manufacturing, quality
assurance/quality control development, statistical analysis and report writing,
clinical studies and regulatory affairs, product approval and registration. When
used as a verb, "Develop" means to engage in Development.
"DROPPED PROGRAM PRODUCT" has the meaning given to that term in Section
2.6.1(b).
"EFFECTIVE DATE" means the date of this Agreement.
"EMEA" means the European Agency for the Evaluation of Medicinal Products, or
any successor thereto.
"EUROPE" means, as of the Effective Date, the countries that are members of the
European Union and the countries that have entered into agreements with the
European Union to be admitted as members to the European Union.
"EXECUTIVE OFFICERS" means the Chief Executive Officer of Anadys (or an
executive of Anadys designated by such Chief Executive Officer) and the Chief
Executive Officer of LGLS (or an executive of LGLS designated by such Chief
Executive Officer).
"FDA" means the United States Food and Drug Administration, or any successor
agency thereto.
"FIRST COMMERCIAL SALE" means, for each Royalty-Bearing Product, on a
country-by-country basis, the first shipment of Royalty-Bearing Product to a
Third Party by the Royalty-Paying Party, its Affiliates or sublicensees in a
country in the Anadys Territory or in China, as applicable, after Regulatory
Approval has been achieved for such Royalty-Bearing Product in such country.
Sales for test marketing, sampling and promotional uses, clinical trial purposes
or compassionate or similar use shall not be considered to constitute a First
Commercial Sale.
"FTE" means a full time equivalent person year of scientific, technical or
managerial work on or directly related to the Joint Development Program.
"FTE COSTS" means the cost attributed to an FTE, as shall be mutually agreed by
the Joint Development Committee.
"GENERIC PRODUCT" means a product that has been approved for marketing (i) in
the United States by the FDA pursuant to an Abbreviated New Drug Application in
accordance with the ▇▇▇▇▇-▇▇▇▇▇▇ Act of 1984, as amended, as a "new drug" (as
defined in said Act) in respect of which the conditions of use prescribed,
recommended, or
3
suggested in the labeling proposed for such new drug have been previously
approved by the FDA for the Product or (ii) in any other country by the
counterpart agency of the FDA in that country pursuant to any similar statute,
regulation or other legal authority in that country.
"GLOBAL DEVELOPMENT BUDGET" means the budget containing the planned Global
Development Costs, in form and substance initially determined and approved by
the Joint Development Committee and as amended and revised from time to time
during the Joint Development Program Term in accordance with the provisions of
this Agreement.
"GLOBAL DEVELOPMENT COSTS" means the costs incurred for or associated with any
[...***...] and [...***...] or other [...***...] which are necessary for
[...***...] contemplated by the Global Development Plan, in each case that are
directly related to [...***...] for treatment of chronic HBV infection in
humans. In addition, Global Development Costs shall include [...***...] for
those activities that [...***...] of the Development of any Compound, including,
[...***...] provided, that such allocations are mutually determined and agreed
by the Joint Development Committee prior to such allocation in accordance with
Section 2.2.4 of this Agreement. Global Development Costs shall not include
costs related to [...***...], including [...***...] of any [...***...]. Global
Development Costs include [...***...] including [...***...] and the [...***...]
Study, and, in respect of studies or Development activities initiated prior to
the Option Period, all the costs incurred by the conduct of such studies or
Development activities after the date Anadys exercises the Option.
"GLOBAL DEVELOPMENT PLAN" means the global clinical development and regulatory
strategy and plan for conducting, coordinating, and allocating resources for the
clinical study and registration of the Program Products in the Anti-HBV Field,
as may be amended from time to time in accordance with the terms of this
Agreement.
"HBV" means Hepatitis B Virus.
"IND" means (a) (i) an Investigational New Drug Application, as defined in the
U.S. Federal Food, Drug, and Cosmetic Act, as amended, and the regulations
promulgated thereunder, that is required to be filed with the FDA before
beginning clinical testing of a Program Product in human subjects, or any
successor application or procedure and (ii) any foreign counterpart of a U.S.
Investigational New Drug Application, and (b) all supplements and amendments
that may be filed with respect to the foregoing.
"INITIATION" means with respect to a clinical study the administration of a
Compound or Program Product to the first subject dosed in such clinical study.
"INTERNAL FTE" means with respect to each Party an FTE that performs scientific,
technical or managerial work on or directly related to the Joint Development
Program, which such work is necessary or advisable to be performed by an
employee of such Party; provided, however, that the term Internal FTE shall not
include any FTE included in the calculation of FTE Costs included in Global
Development Cost.
"INVENTIONS" means any processes, methods, techniques, formulas, equipment
designs, know-how, show-how and trade secrets, discoveries, practices,
technology, designs, works of authorship, instructions, and other intellectual
property, patentable or otherwise, tangible or intangible, including, without
limitation, as described in ▇▇▇▇▇▇▇ ▇▇▇ ▇▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ Patent Law, any new
and useful process, machine, manufacture, or composition of matter, or any new
and useful improvement thereof.
"JOINT DEVELOPMENT COMMITTEE" means the committee formed pursuant to Section
3.1.
***Confidential Treatment Requested
4
"JOINT DEVELOPMENT PROGRAM" means the joint development program to be conducted
by the Parties in accordance with the Global Development Plan and this
Agreement.
"JOINT DEVELOPMENT PROGRAM TERM" means the term of the Joint Development Program
set forth in Section 2.1.2.
"JOINT STEERING COMMITTEE" means the committee formed pursuant to Section 5.6.
"JOINT INVENTIONS" has the meaning given to that term in Section 6.1.4.
"JOINT PATENT RIGHTS" has the meaning given to that term in Section 6.1.4.
"LAWS" means all laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any federal, national, multinational,
state, provincial, county, city or other political subdivision, domestic or
foreign.
"LGLS INVENTIONS" means Inventions conceived of and reduced to practice in the
course of the Joint Development Program solely by employees and agents of LGLS.
"LGLS KNOW-HOW" means any know-how, trade secret, experimental data, formula,
expert opinion, experimental procedure, pre-clinical and clinical data,
regulatory data and filings and other confidential and/or proprietary
information concerning any Compound or Program Product or its manufacture or use
(including, but not limited to the Global Development Plan, all results of any
experiment or study undertaken prior to the Effective Date, LGLS Inventions,
Joint Inventions assigned to LGLS under Section 6.1.4 and any intellectual
property created as a result of performing the Global Development Plan) that is
Controlled by LGLS and that is necessary or useful for either (i) the
formulation, manufacture, development, use, and/or application of any Compound
or Program Product, or (ii) establishing clinical trials and obtaining
registration of any Compound or Program Product.
"LGLS PATENT RIGHTS" means (i) the patents and the patent applications referred
to in Exhibit A and any other patents and patent applications [...***...] that
are [...***...], or [...***...] that are [...***...] or [...***...] including,
without limitation, such claims [...***...] or [...***...] to [...***...] (ii)
all foreign counterparts of any of the patents and patent applications specified
in clause (i) of this definition; and (iii) [...***...] that provide [...***...]
to the [...***...] in the applicable [...***...] the [...***...] or [...***...]
of [...***...] to any of the foregoing.
"LGLS TERRITORY" means the following countries and territories: Korea, China,
Taiwan, Hong Kong, Macao, Bangladesh, Bhutan, Nepal, India, Sri Lanka, Pakistan,
Thailand, Laos, Myanmar, Philippines, Vietnam, Indonesia, Singapore, Malaysia,
Brunei, and Cambodia.
"MARKET EXCLUSIVITY" means, with respect to a Program Product in a country, any
law, regulation, decree or other right that prohibits a third party from
manufacturing, using, selling, promoting, marketing, distributing or importing
such Product in that country in the absence of the license granted under this
License Agreement.
"NDA" means (a) (i) a New Drug Application pursuant to 21 U.S.C. Section
505(b)(1) submitted to the FDA or any successor application or procedure and
(ii) any non-U.S. counterpart of a U.S. New Drug Application, and (b) all
supplements and amendments, including supplemental New Drug Applications (and
any foreign counterparts), that may be filed with respect to the foregoing.
"NET SALES" means, with respect to a Program Product, the gross receipts
representing sales of such Program Product to Third Parties by a Party and its
Affiliates and sub-licensees in the that Party's Territory, less deductions for
the following items:
5
(i) reasonable transportation and insurance charges borne by the selling
party,
(ii) sales and excise taxes or customs duties paid by the selling party
and any other governmental charges imposed upon the sale of the
Product,
(iii) rebates or allowances actually granted or allowed, including
government and managed care rebates,
(iv) quantity discounts, cash discounts or chargebacks actually granted,
allowed or incurred in the ordinary course of business in connection
with the sale of the Product, and
(v) allowances or credits to customers, not in excess of the selling
price of the Product, on account of governmental requirements,
rejection, outdating, recalls or return of the Product.
Sales between a Party and its Affiliates and sub-licensees shall be excluded
from the computation of Net Sales and no royalties shall be payable on such
sales.
"OPTION" has the meaning given to that term in the Recitals to this Agreement.
"OPTION AGREEMENT" has the meaning given to that term in the Recitals to this
Agreement.
"OPTION PERIOD" means the period of time commencing on February 17, 2004 and
ending on the Effective Date.
"PARTY" means Anadys or LGLS; "PARTIES" means Anadys and LGLS.
"PATENT RIGHTS" means all existing patents and patent applications and all
patent applications hereafter filed, including any continuations,
continuations-in-part, divisions, provisionals or any substitute applications,
any patent issued with respect to any such patent applications, any reissue,
reexamination, renewal or extension (including any supplemental patent
certificate) of any such patent, and any confirmation patent or registration
patent or patent of addition based on any such patent, and all foreign
counterparts of any of the foregoing.
"PHASE 2B STUDY" means a dose ranging clinical trial, including, without
limitation, the [...***...] Study, to evaluate further the efficacy and safety
of a candidate drug in the targeted patient population and to define the optimal
dosing regimen.
"PHASE 3 STUDY" means a clinical trial to confirm with statistical significance
the efficacy and safety of the drug in larger, targeted patient populations,
performed to obtain approval of a product application.
"PROGRAM PRODUCT" means any pharmaceutical formulation containing a Compound for
administration to humans to treat chronic HBV infection.
"PROGRAM MATERIAL" means any Program Products, Compounds and any material first
identified or discovered in the conduct of the Joint Development Program,
including, without limitation, biological materials such as tissue samples,
receptors, reagents and screens.
"PROGRAM TECHNOLOGY" means any Invention, information, data, results from any
experiment or study, including, without limitation, clinical trial results, that
(a) is Controlled by a Party or jointly by the Parties and, (b) (i) relates to
the Anti-HBV Field, is utilized in the Joint Development Program (but only to
the extent so utilized), and is discovered or acquired by a Party and/or any of
its Affiliates during the Joint Development Program Term but outside of the
conduct of the Joint Development Program, or (ii) is first invented or
discovered in the conduct of the Joint Development Program or in the course of
the Development or Commercialization of any Program Product. For clarity,
Program Technology excludes Program Materials, LGLS Know-how, LGLS Patent
Rights, LGLS Inventions, and Anadys Inventions.
***Confidential Treatment Requested
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"REGULATORY APPROVAL" means in any country or political subdivision thereof in a
Territory any and all approvals (including any applicable governmental price and
reimbursement approvals), licenses, registrations, permits, authorizations or
the like of any Regulatory Authority in such country or political subdivision
thereof that is necessary or advisable to have been issued or granted in order
to Develop and/or Commercialize pharmaceutical compounds or drug products in
that country or political subdivision thereof.
"REGULATORY AUTHORITY" in any country or political subdivision thereof in a
Territory the federal, national, multinational, state, provincial or local
regulatory agency, department, bureau or other governmental entity or like
authority in such country or political subdivision with jurisdiction over the
Development and/or Commercialization of pharmaceutical compounds and drug
products in that country or political subdivision thereof.
"ROYALTY-BEARING PRODUCT" means a Program Product.
"ROYALTY-PAYING PARTY" means, with respect to a Royalty-Bearing Product, the
Party obligated to pay royalties to the other Party under any of the provisions
of Article 5.
"TERRITORY" means the Anadys Territory or the LGLS Territory, as applicable.
THIRD PARTY" means any entity other than Anadys or LGLS or an Affiliate of
Anadys or LGLS.
"UNILATERAL PRODUCT" has the meaning given to that term in Section 2.6.1(b).
"VALID CLAIM" means a claim (a) of any issued, unexpired patent [...***...] or
[...***...] by a [...***...] of a [...***...] of [...***...] from which
[...***...] to which [...***...] is [...***...] the [...***...] for [...***...]
and which [...***...] or [...***...] or [...***...] through [...***...] or (b)
of any patent application which shall not have been [...***...] nor been
[...***...] for [...***...] [...***...] [...***...][...***...] for such
[...***...].
ARTICLE 2
JOINT DEVELOPMENT PROGRAM
2.1 GENERAL.
2.1.1 COLLABORATION. During the Joint Development Program Term, the
Parties shall collaborate with each other in carrying out the Joint
Development Program as set forth in the then current Global
Development Plan.
2.1.2 TERM. The term of the Joint Development Program (the "Joint
Development Program Term") shall commence on the Effective Date and
end on the earlier to occur of the termination or expiration of this
Agreement as specified in Article 10.
2.1.3 EXCLUSIVITY. During the Joint Development Program Term, [...***...],
shall not [...***...] in [...***...] [...***...] the [...***...] of
which is the [...***...] and [...***...] of any [...***...] for
[...***...] in [...***...] other than [...***...] in accordance with
the [...***...]; provided, however, that this [...***...] shall not
apply to the [...***...] as [...***...] or [...***...] of the
[...***...] of [...***...], including, without limitation,
[...***...] and the like, as long as [...***...] containing such
[...***...] or [...***...] of [...***...] of [...***...] shall
[...***...] affect [...***...].
2.2 JOINT DEVELOPMENT COMMITTEE.
2.2.1 FORMATION AND MEMBERSHIP. Promptly after the Effective Date, but not
later than [...***...] ([...***...]) days after Effective Date,
Anadys and LGLS shall establish a Joint Development Committee (the
"Joint Development Committee") comprised of three (3)
representatives designated by Anadys and three (3) representatives
designated by LGLS, with the right of each party to designate
successive
***Confidential Treatment Requested
7
substitutes for its representatives; provided that such equal number
of representatives shall be increased or decreased as may be
determined by the Joint Development Committee. The Joint Development
Committee shall be chaired by one representative of LGLS to be
designated by LGLS and one representative of Anadys to be designated
by Anadys, with the right of each party to designate successive
substitutes for its designee.
2.2.2 RESPONSIBILITIES. The Joint Development Committee shall have overall
responsibility for managing, directing, overseeing and implementing
the Global Development Plan, but shall not have any power to amend,
modify or waive compliance with the terms of this Agreement. The
Joint Development Committee shall be responsible for, among other
things:
(a) Preparing the content of the Global Development Plan and
Global Development Plan Budget as provided in Sections 2.3 and
2.5 hereof for review and approval by the Joint Steering
Committee in accordance with Section 5.6.4;
(b) providing a forum for consensual decision making relating to
the initial Global Development Plan and its amendment from
time to time during the Joint Development Project Term;
(c) monitoring the Parties' compliance with their respective
obligations under the Global Development Plan.
2.2.3 ADMINISTRATIVE MATTERS. The chairs of the Joint Development
Committee shall be responsible for calling meetings of the Joint
Development Committee to be held in accordance with Section 2.2.5,
for distributing a proposed agenda in advance of each meeting called
by such chairs, and for leading such meetings. At each meeting of
the Joint Development Committee, a Joint Development Committee
member of the Party appointed by the Chairs of the Joint Development
Committee shall serve as secretary of that meeting and shall record
the minutes of such meeting. Such minutes shall provide a
description in reasonable detail of the discussions had at the
meeting and a list of any actions, decisions or determinations
approved by the Joint Development Committee. The secretary of each
meeting shall distribute to all members of the Joint Development
Committee such minutes within [...***...] ([...***...]) weeks after
such meeting At such next meeting, the Joint Development Committee
shall approve or disapprove of such minutes, and such minutes shall
be revised as necessary for further review and approval or
disapproval by the Joint Development Committee. Final minutes of
each meeting shall be distributed to the members of the Joint
Development Committee by the member of the Joint Development
Committee who served as secretary at such meeting or such member's
replacement, if any.
2.2.4 DECISION MAKING. The Joint Development Committee will attempt in
good faith to make decisions by consensus with respect to any
matters that properly come before it. If the Joint Development
Committee cannot reach consensus on a matter within [...***...]
([...***...]) days from the day the matter is so submitted to them,
the Joint Development Committee shall refer such matter to the Joint
Steering Committee to attempt in good faith to reach a mutually
agreeable decision in accordance with Section 5.6.4. If the Joint
Steering Committee cannot reach consensus on the matter within
[...***...] ([...***...]) days from the day the matter is so
submitted to them, the Joint Steering Committee shall refer such
matter to the Chief Executive Officers ("CEOs") of LGLS and Anadys
to attempt in good faith to reach a mutually agreeable decision. If
the CEOs cannot reach consensus on the matter within [...***...]
([...***...]) days from the day the matter is so submitted to them,
then the matter shall be [...***...] in accordance with
[...***...];[...***...],[...***...], that for the [...***...] of
[...***...] from the [...***...] until the [...***...] of the
[...***...], if the [...***...] cannot [...***...] any such
[...***...] so [...***...] to them for [...***...] within
[...***...] from the [...***...] the [...***...]is so [...***...] to
them, then [...***...] shall have the [...***...]; provided that
[...***...] in the then [...***...] that is [...***...] of the then
[...***...] contained therein [...***...].
2.2.5 MEETINGS.
***Confidential Treatment Requested
8
(a) The Joint Development Committee shall meet at least
[...***...] ([...***...]) times per year following its
formation during the term of the License Agreement. Such
meetings shall be held at such times and places as are
mutually agreed upon by the Joint Development Committee, with
at least [...***...] ([...***...]) such meetings per year to
be [...***...]; and at meetings not designated as being
[...***...], the representatives may participate by means of
conference telephone or similar communications equipment by
means of which all persons participating in the meeting can
hear each other.
(b) Each Party shall use commercially reasonable efforts to cause
its representatives to attend the meetings of the Joint
Development Committee in person. If a representative of a
Party is unable to attend a meeting, such Party may designate
an alternate representative to attend such meeting in place of
the absent representative. In addition, each Party may, at its
discretion, invite additional employees, and, with the consent
of the other Party, consultants or scientific advisors, to
attend the meetings of the Joint Development Committee.
(c) Either Party may also convene a special meeting of the Joint
Development Committee for the purpose of resolving disputes or
for the purpose of reviewing (or making) a decision pertaining
to the Global Development Plan by providing at least
[...***...] ([...***...]) Business Days written notice to the
other Party.
2.3 GLOBAL DEVELOPMENT PLAN.
2.3.1 CONTENTS. The Global Development Plan shall contain a chronology of
the specific objectives and milestones comprising the Joint
Development Program, a chronology of the actions to be undertaken by
each Party to achieve such objectives and milestones in a timely
manner, and the Global Development Budget. The Global Development
Plan shall be consistent with the other terms and conditions of this
Agreement.
2.3.2 INITIAL ADOPTION. The Joint Development Committee shall prepare and
approve and the Joint Steering Committee shall approve in accordance
with Section 5.6.4 the initial version of the Global Development
Plan (including the details of the [...***...] Study and the details
of the [...***...] required for Regulatory Approval) within
[...***...] ([...***...]) [...***...] following the Effective Date;
provided, however, that to the extent the manufacturing and
chemistry manufacturing and controls audits are not complete due to
the lack of cooperation by LGLS, and the data listings are not
provided by LGLS to Anadys within [...***...] ([...***...])
[...***...] following the Effective Date, then the timeline for
finalization of the Global Development Plan may be extended beyond
such [...***...] ([...***...]) [...***...] period by the number of
days of such delay.
2.3.3 AMENDMENT. The Joint Development Committee shall, in accordance with
Section 2.2.4, update and amend, as necessary or advisable, the then
current Global Development Plan from time to time during the Joint
Development Program Term; provided that no less than annually during
the last calendar quarter of each calendar year during the Joint
Development Project Term, the Joint Development Committee shall
review the Global Development Plan and shall either (a) amend or
revise the Global Development Plan as the Joint Development
Committee deems necessary or advisable or (b) expressly confirm that
such amendment or revision is not then necessary or advisable. All
such amendments of the Global Development Plan shall be subject to
the approval of the Joint Steering Committee pursuant to Section
5.6.4.
2.4 CONDUCT OF THE JOINT DEVELOPMENT PROGRAM.
2.4.1 OBJECTIVE. The Parties shall conduct the Joint Development Program
in a manner reasonably likely to result in the achievement of the
objectives and milestones in accordance with such program
progression guidelines. Each Party shall use commercially reasonable
efforts to conduct the activities of the Joint Development Program
which are assigned to it in the Global Development Plan. The Parties
acknowledge
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and agree that neither Party guarantees the success of the tasks to
be undertaken by it in accordance with the Global Development Plan.
2.4.2 COMPLIANCE WITH LAW. Each Party agrees to conduct such Development
activities in compliance with all Laws that are applicable to the
particular stage of Development of each Compound or Program Product,
including without limitation, Good Laboratory Practices, Good
Clinical Practices and Good Manufacturing Practices.
2.4.3 PROGRAM DIRECTORS. Each Party shall identify one of its
representatives to serve as a program director with responsibility
for overseeing that Party's day-to-day activities relating to the
Joint Development Program and to serve as a contact person for
coordinating Joint Development Program activities between the
Parties.
2.4.4 ALLOCATIONS OF FTES.
(a) In addition to sharing the Global Development Costs in
accordance with Section 2.5.1, [...***...] to the Joint
Development Program activities over the course of the Joint
Development Program. All FTE utilization shall be expressly
provided for in the Global Development Plan or otherwise
approved by the Joint Development Committee. The Joint
Development Committee may, in accordance with Section 2.2.4,
amend the Global Development Plan as [...***...] and
participation by the Parties over the course of the Joint
Development Program, and any such amendment shall be subject
to the approval of the Joint Steering Committee in accordance
with Section 5.6.4.
(b) If either Party [...***...] in [...***...] to, or [...***...]
by the Parties in, the Joint Development Program, such Party
may submit the matter to the Joint Development Committee.
Taking into account [...***...] and [...***...] in and to the
Joint Development Program by the Parties, the Joint
Development Committee shall [...***...] [...***...]
[...***...] by the Parties in the Joint Development Program.
At the request of a Party, the other Party shall [...***...]
Party, at reasonable times and upon reasonable notice but
[...***...] to [...***...] at [...***...] of [...***...] of
the [...***...] the [...***...] the other Party to the Joint
Development Committee regarding [...***...] Joint Development
Program by such Party.
2.4.5 JOINT DEVELOPMENT PROGRAM RECORDS.
(a) In order to protect the Patent Rights under any applicable Law
in any inventions conceived or reduced to practice during or
as a result of the Joint Development Program, each Party
agrees to maintain a policy which requires its employees to
record and maintain all data and information developed during
the Joint Development Program in such a manner as to enable
the Parties to use such records to establish the earliest date
of invention and/or diligence to reduction to practice.
2.4.6 LIABILITY. In connection with conduct of the Joint Development
Program, each Party shall be responsible for, and hereby assumes,
any and all risks of personal injury or property damage attributable
to the negligent acts or omissions of that Party or its Affiliates,
and their respective directors, officers, employees and agents.
2.4.7 SUBCONTRACTORS. Either Party may perform some of its obligations
under the Joint Development Program through one or more
subcontractors; provided that (a) none of the rights of the other
Party hereunder are diminished or otherwise adversely affected as a
result of such subcontracting, (b) such Party obtains the written
approval of the other Party prior to engaging any subcontractor,
which approval shall not be unreasonably withheld or delayed, and
(c) the subcontractor undertakes in writing obligations relating to
the ownership and protection of Patent Rights in the Program
Technology set forth in this Agreement and
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confidentiality and non-use regarding the other Party's Confidential
Information which are substantially the same as those undertaken by
Anadys and LGLS pursuant to Article 9 hereof. In the event a Party
performs one or more of its obligations under the Joint Development
Program through a subcontractor, then such Party shall at all times
be responsible for the performance of such subcontractor. For the
avoidance of doubt, it is understood that an Affiliate of a Party
shall not be deemed to be a subcontractor of such Party
2.4.8 CLINICAL SUPPLIES OF COMPOUNDS.
(a) LGLS will supply sufficient quantities of the Compounds as
bulk drug substance to support on a global basis the conduct
of the human clinical trials through completion of Phase 2b
Studies contemplated by the Global Development Plan. In
addition, LGLS shall have the option to provide finished
Program Product formulated from such quantities of the
Compounds to support such clinical trials.
(b) Clinical Supply Costs incurred by the Parties shall be deemed
to be Global Development Costs.
(c) All Compounds or Program Product, as applicable, provided by
LGLS to Anadys shall (i) be used only in furtherance of the
Joint Development Program and in accordance with the Global
Development Plan, (ii) be used solely under the control of
Anadys and its Affiliates, (iii) not be used or delivered to
or for the benefit of any Third Party without the prior
written consent of LGLS, and (iv) not be used in research or
testing involving human subjects except as set forth in an IND
or similar approval from the Regulatory Authority having
jurisdiction over such research or testing effective for human
clinical trials of such Compounds or Program Product, as
applicable, and with the requisite degree of care, prudence
and appropriate caution for conducting clinical trials in
humans experimental work dictated by applicable Laws and
custom.
(d) All quantities of Compounds or Program Products, as
applicable, supplied by LGLS to Anadys under this Section
2.4.8 shall be of GMP quality and shall comply with the
specifications for such Compounds or Program Products, as
applicable, set forth in the Global Development Plan and in
the international dossier relating thereto. EXCEPT FOR THIS
REPRESENTATION AND WARRANTY AS TO SUCH GMP QUALITY AND
COMPLIANCE WITH SUCH SPECIFICATIONS, THE COMPOUNDS OR PROGRAM
PRODUCTS, AS APPLICABLE, ARE PROVIDED "AS IS" AND WITHOUT ANY
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE
USE OF SUCH COMPOUNDS OR PROGRAM PRODUCTS, AS APPLICABLE, WILL
SUCCESSFULLY TREAT THE INDICATION IN RESPECT OF WHICH SUCH
COMPOUNDS OR PROGRAM PRODUCTS, AS APPLICABLE, ARE BEING
PROVIDED FOR CLINICAL STUDIES THEREOF.
2.4.9 NON-SOLICITATION. During the Joint Development Program Term, and for
a period of [...***...] ([...***...])[...***...] thereafter, neither
Party shall either directly or indirectly solicit, recruit, induce,
encourage or attempt to induce or encourage any employee of the
other Party or any independent contractor primarily dedicated to the
Joint Development Program or in Commercialization activities to
terminate his or her employment with such other Party and become
employed by or consult for such other Party whether or not such
employee is a full-time employee of such other Party, whether or not
such employment is pursuant to a written agreement or is at-will.
2.5 GLOBAL DEVELOPMENT COSTS AND BUDGET.
2.5.1 ALLOCATION OF GLOBAL DEVELOPMENT COSTS. Anadys and LGLS will each
bear fifty percent (50%) of the Global Development Costs.
2.5.2 GLOBAL DEVELOPMENT BUDGET.
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(a) The Global Development Budget shall be included, among other
things, in the Global Development Plan. The Global Development
Budget shall include reasonable estimates of total Global
Development Costs and allocation of Internal FTEs on a
year-by-year basis and specify in reasonable detail on a
study-by-study and activity-by-activity basis the Global
Development Costs expected to be incurred for the current and
next succeeding calendar years.
(b) The Global Development Budget shall be approved by the Joint
Development Committee in accordance with the provisions of
Sections 2.2.4 and 2.3 hereof, and further approved by the
Joint Steering Committee in accordance with Section 5.6.4 and
during the last quarterly meeting of each calendar year, the
Joint Development Committee shall review and propose
modifications for the Joint Steering Committee to approve in
accordance with Section 5.6.4, as necessary or advisable, the
Global Development Budget, and shall in connection therewith
specify in reasonable detail on a study-by-study and
activity-by-activity basis the Global Development Costs
expected to be incurred for the next succeeding calendar year.
Subject to the provisions of Sections 2.2.4 and 2.3 hereof,
any such amendment shall be by written agreement signed by a
representative from each Party and the Global Development
Budget as so amended and agreed by the Parties will thereupon
become effective.
(c) The Joint Development Committee shall review on a quarterly
basis any variance between actual Global Development Costs and
budgeted Global Development Costs for the immediately
preceding quarter, shall determine the reasons for any such
variances, assess whether such variances are likely to
continue, and, if necessary or advisable, agree on a revised
Global Development Budget or otherwise request that one or
both Parties take such actions as are required to address or
remedy the continuation of such variance.
2.5.3 REIMBURSEMENT OF GLOBAL DEVELOPMENT COSTS.
(a) Upon execution of this Agreement, [...***...] in [...***...]
representing [...***...].
(b) At each quarterly meeting of the Joint Development Committee,
the Joint Development Committee shall determine if the Global
Development Costs and allocation of Internal FTEs incurred by
the Parties during the preceding calendar quarter have been
borne by the Parties in accordance with Section 2.5.1 hereof.
To the extent that one Party has paid more than its allocable
share pursuant to Section 2.5.1 and the other Party has paid
less than its allocable share pursuant to Section 2.5.1, the
Party that has so underpaid shall within [...***...]
([...***...]) days following such determination pay to the
Party that has so overpaid the amount by which such Party has
so overpaid, as determined by the Joint Development Committee.
2.6 DISCONTINUED DEVELOPMENT.
2.6.1 UNILATERAL DECISION.
(a) In the event that either Party elects not to continue its
participation in Development of a Program Product, such Party
(as the "First Party") shall provide written notice to the
other Party (as the "Second Party") of such election (a
"Notice of Discontinuance"). Upon providing a Notice of
Discontinuance, such First Party's obligations with respect to
such discontinued Program Product shall cease, subject to
acting in good faith with respect to the winding down or
transition of studies that may be necessary so as not to
adversely affect the Development of such Program Product by
the other Party.
(b) Upon receipt of a Notice of Discontinuance, the Second Party,
by providing written notice to the First Party within
[...***...] ([...***...]) days of receipt of the Notice of
Discontinuance, may elect
(i) to also discontinue Development of such Program Product,
and such Program Product shall thereupon be deemed a
"Dropped Program Product", or
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(ii) to continue Development of the Program Product, and such
Program Product shall thereupon become a "Unilateral
Product" and cease being a Program Product.
(c) In the case of any Unilateral Product,
(i) if the Party electing to continue Development thereof is
LGLS, then (A) LGLS shall pursue such Development in
accordance with its retention of ownership of all LGLS
Patent Rights and its rights to or under the Program
Technology, Program Materials, the Global Development
Plan, the Joint Patent Rights assigned to Anadys under
Section 6.1.4 and licensed to LGLS under Section 3.1.2,
and Anadys's Patent Rights to the Anadys Inventions
licensed to LGLS under Section 3.1.2 and (B) in the case
of such Joint Patent Rights and such Patent Rights in
the Anadys Inventions, LGLS and Anadys shall negotiate
in good faith the terms and conditions under which LGLS
may so continue to use such Joint Patent Rights and such
Patent Rights for continued Development and
Commercialization of such Unilateral Product, or
(ii) if the Party electing to continue Development thereof is
Anadys, then (A) Anadys shall pursue such Development in
accordance with its license to the LGLS Patent Rights
and LGLS Know-How and its rights to or under the Program
Technology, Program Materials (excluding any right to be
supplied by LGLS with clinical supplies of such
Unilateral Product or the Compound comprising such
Unilateral Product), the Global Development Plan, and
(B) in the case of the LGLS Patent Rights and LGLS
Know-how, if Anadys desires to renegotiate the terms and
conditions of this Agreement, then LGLS and Anadys shall
negotiate in good faith the terms and conditions under
which Anadys may so continue to use the LGLS Patent
Rights and LGLS Know-How for continued Development and
Commercialization of such Unilateral Product.
2.6.2 JOINT DECISION. In the event that both Parties mutually elect not to
continue their participation in the Development of a Program
Product, by exchange of mutual Notices of Discontinuance or mutual
written agreement, then such Program Product shall thereupon be
deemed a Dropped Program Product. Any mutual election of the Parties
to not continue their participation in Development of a Program
Product shall have no effect on (i) LGLS's continued ownership of
all LGLS Patent Rights and LGLS Know-how, its rights in the Program
Technology, Program Materials and the Global Development Plan, and
the license granted by Anadys to LGLS under Section 3.1.2 to the
extent such license relates to other Program Products, and (ii)
Anadys's continued ownership of all its Patent Rights in the Anadys
Inventions, its rights in the Program Technology, Program Materials
and the Global Development Plan, and the license granted by LGLS to
Anadys under Section 3.1.1 to the extent such license relates to
other Program Products.
2.6.3 EFFECT ON GLOBAL DEVELOPMENT PLAN. If a Program Product becomes a
Dropped Program Product pursuant to Sections 2.6.1(b)(i) or 2.6.2 or
becomes a Unilateral Product pursuant to Section 2.6.1(b)(ii), then
the Joint Development Committee shall promptly revise the Global
Development Plan as necessary or advisable to reflect such change in
the status of such Program Product.
ARTICLE 3
LICENSES
3.1 SCOPE.
3.1.1 LGLS GRANT TO ANADYS. Subject to the terms and conditions of this
Agreement, LGLS hereby grants to Anadys an exclusive royalty-bearing
license, with the right to sublicense, under all LGLS Patent Rights
and LGLS Know-How, including, without limitation, LGLS's rights in
LGLS Inventions, to develop, make, have made, use, register, offer
to sell, sell, export and import the Compounds and Program Products
in the Anadys Territory in the Anti-HBV Field.
3.1.2 ANADYS GRANT TO LGLS. Subject to the terms and conditions of this
Agreement, Anadys hereby grants to LGLS an exclusive license,
non-royalty-bearing except with respect to Net Sales of Program
Products in China, with the right to sublicense, under all Patent
Rights in the Anadys Inventions and Joint Patent
13
Rights assigned to Anadys under Section 6.1.4 of this Agreement, and
know-how of Anadys relating to such Anadys Inventions and such Joint
Patent Rights, to develop, make, have made, use, register, offer to
sell, sell, export and import the Compounds and Program Products in
the LGLS Territory in the Anti-HBV Field.
3.1.3 PROGRAM TECHNOLOGY AND PROGRAM MATERIALS. Subject to the terms and
conditions of this Agreement, LGLS hereby grants to Anadys
[...***...] license during the term of this Agreement under
[...***...] in the [...***...] and the [...***...] [...***...] for
the purpose of [...***...]. Subject to the terms and conditions of
this Agreement, Anadys hereby grants to LGLS a [...***...] license
during the term of this Agreement under Anadys's interest in the
[...***...] and the [...***...] for the purpose of [...***...]
[...***...] to [...***...] the [...***...]; provided, however, that
[...***...] shall not be required for [...***...] by either Party
[...***...] contemplated by the Global Development Plan, by LGLS to
[...***...] for Development and Commercialization of Compounds and
Program Products [...***...] or by Anadys to [...***...] within the
[...***...] for Development and Commercialization of Compounds and
Program Products [...***...]
3.2 SUBLICENSES.
3.2.1 The right granted to Anadys in Section 3.1.1 to sublicense the
rights granted in said Section 3.1 is subject to the following
conditions:
(a) any such sublicense (each a "Sublicense") to any sublicensee
(each an "Anadys Sublicensee") will be consistent with and not
contravene in any way the rights of LGLS under this Agreement
and will be set forth in a written agreement containing terms
and conditions substantially similar to those contained in
this Agreement, provided that the scope of the rights granted
in any Sublicense may not exceed, but may be the same or less
than, the scope of the rights granted to Anadys in said
Section 3.1, and further provided [...***...];
(b) [...***...] will [...***...] the [...***...] of [...***...]
with [...***...] on the [...***...] of [...***...], and the
[...***...] of any such [...***...] to any [...***...] is
[...***...] to the [...***...] in [...***...], and [...***...]
under [...***...] that is [...***...] in [...***...] with
[...***...] be [...***...].
3.2.2 If this Agreement is terminated for any reason, [...***...] to
[...***...] the [...***...] to [...***...] the [...***...] of
[...***...] as [...***...] by [...***...], and [...***...] shall
[...***...] such [...***...] as may be [...***...] by [...***...] to
[...***...] the [...***...] to [...***...] of all of [...***...],
including, without limitation, the [...***...] any [...***...] due
[...***...] under such [...***...].
3.2.3 [...***...].
3.2.4 The terms and conditions of Sections 3.2.1, 3.2.2 and 3.2.3 shall
apply mutatis mutandis to the right granted to LGLS in Section 3.1.2
to sublicense the rights granted in said Section 3.1.2.
3.3 RETAINED RIGHTS.
3.3.1 GENERALLY. With respect to this Agreement, [...***...] to
[...***...] under the [...***...], including, without limitation,
[...***...] and [...***...] the [...***...].
3.3.2 GLOBAL DEVELOPMENT PLAN. Subject to the rights granted to Anadys
under this Agreement, the [...***...],[...***...]of [...***...].
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3.3.3 [...***...]
ARTICLE 4
REGULATORY MATTERS
4.1 LEAD REGULATORY PARTIES.
4.1.1 APPOINTMENTS. [...***...] will be the [...***...] in the
[...***...], and [...***...] will be the [...***...] in the
[...***...].
4.1.2 RESPONSIBILITY OF LEAD REGULATORY PARTY. Unless otherwise determined
by the Joint Development Committee, the Lead Regulatory Party in
each Territory shall (a) be responsible for obtaining the Regulatory
Approvals for the Compounds and Program Products contemplated by the
Global Development Plan in each country or political subdivision
thereof in such Territory and (b) shall take all actions, including,
without limitation, corresponding, meeting, communicating,
interfacing and making filings with and submissions to the
Regulatory Authorities in such countries or political subdivisions
thereof in such Territory as are necessary or advisable to obtain in
the name of such Lead Regulatory Party all such Regulatory
Approvals.
4.2 OWNERSHIP OF REGULATORY APPROVALS.
4.2.1 ANADYS TERRITORY. Anadys shall hold all Regulatory Approvals for
Program Products for all countries in the Anadys Territory, unless
otherwise determined by the Joint Development Committee.
4.2.2 LGLS TERRITORY. LGLS shall hold all Regulatory Approvals for Program
Products for all countries in the LGLS Territory, unless otherwise
determined by the Joint Development Committee.
4.2.3 TRANSFERS FOR DEVELOPMENT AND COMMERCIALIZATION.
(a) The Lead Regulatory Party in each Territory shall license,
transfer, provide a letter of reference with respect to, or
take other action necessary to make available such INDs or
NDAs as are filed in each country in such Territory to the
other Party as may be reasonably necessary to enable such
other Party to fulfill its obligations under the Global
Development Plan with respect to the Development of such
Compounds and Program Products and under the Global
Commercialization Plan with respect to the Commercialization
of such Program Product.
(b) If the license granted to Anadys in Section 3.1 hereof with
respect to any Compound or Program Product terminates prior to
the License Termination Date in respect of such Compound or
Program Product or such Compound or Program Product becomes a
Unilateral Product of LGLS, Anadys shall transfer and take all
such other action as is necessary or advisable to transfer to
LGLS the full right, title and interest to any Regulatory
Approvals in respect of such Compound or Program Product then
held by Anadys.
4.3 REGULATORY COORDINATION.
4.3.1 INFORMATION EXCHANGE. The Parties shall establish procedures to
ensure that the Parties exchange on a timely basis all necessary
information to enable compliance with all regulatory obligations on
a global basis, including without limitation filing updates, adverse
event reports, and investigator notifications.
4.3.2 REGULATORY MEETINGS AND CORRESPONDENCE. To the extent practicable,
the Party that is not the Lead Regulatory Party in a Territory shall
have the right to have a representative participate in all material
meetings and telephone discussions between representatives of the
Lead Regulatory Party in such Territory and the Regulatory Authority
in any country in such Territory with respect to any Compound or
Program Product.
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4.3.3 REVIEW OF CORRESPONDENCE AND PROPOSED SUBMISSIONS.
(a) To the extent practicable, the Lead Regulatory Party in each
Territory shall provide the other Party with drafts of any
documents or other correspondence to be submitted to the
Regulatory Authorities in the countries comprising such
Territory pertaining to the Compounds or Program Products for
which Regulatory Approval is being sought in such country in
accordance with the Global Development Plan, sufficiently in
advance of submission so that the other Party may review and
comment on such documents and other correspondence and have a
reasonable opportunity to influence the substance of such
submissions. Each Lead Regulatory Party agrees to consider all
such comments from the other Party in good faith, taking into
account the best interest of the Compound or Program Product,
as applicable, on a global basis. If after considering in good
faith such comments regarding the content of a proposed
submission to a Regulatory Authority, the Lead Regulatory
Party disagrees with the other Party's view, such Lead
Regulatory Party shall notify the other Party in writing (a
"Notice of Disagreement").
(b) If a Party receiving a Notice of Disagreement believes that
the proposed submission of the other Party in such other
Party's capacity as a Lead Regulatory Party is likely to have
a material adverse effect on the Development of the applicable
Compound or Program Product on a global basis, such Party
shall so notify such Lead Regulatory Party within [...***...]
([...***...]) business days following receipt of the Notice of
Disagreement and thereupon have the right to request that the
Joint Development Committee immediately convene, either in
person or by telephone, in order to discuss the matter. Any
such meeting shall occur within [...***...] ([...***...])
business days following such request for such meeting. The
resolution of such matter shall thereupon be decided in
accordance with the provisions set forth in Section 2.2.4.
(c) The Lead Regulatory Party in each Territory shall promptly
provide to the other Party copies of any documents or other
correspondence received from the Regulatory Authorities in
such Territory pertaining to the relevant Compound or Program
Product (including without limitation any meeting minutes),
which such documents or other correspondence shall be in the
language of the originals of documents or correspondence.
4.3.4 REGULATORY ASSISTANCE.
(a) Each Party shall cooperate with the other Party to provide all
reasonable assistance and take all actions reasonably
requested by the other Party that are necessary or desirable
to enable the other Party to comply with any Law applicable to
any Compound or Program Product, including, but not limited
to, report adverse drug experience reports (and serious
adverse drug experience reports) to the relevant Regulatory
Authority and submit or file promotional materials with the
relevant Regulatory Authority. The Parties will work in good
faith together to develop a global safety data base containing
such information relating to the Global Development Plan and
the safety of the Compounds and the Program Products as the
Parties may require to comply with applicable Law and
otherwise monitor the safety of the Compounds and the Program
Products. Each Party has the right to review any documents
relating to the Global Development Plan in the possession of
the other Party to ensure compliance with global regulatory
standards, upon reasonable prior written notice to the other
party.
(b) Such assistance and actions shall include, among other things,
keeping the other Party informed, within an appropriate period
of time relevant to any Regulatory Authority requirements
applicable to such other Party or otherwise reasonable period
of time, of notification of any action by, or notification or
other information which it receives (directly or indirectly)
from, any Regulatory Authority, which (a) raises any material
concerns regarding the safety or efficacy of any Program
Product, (b) which indicates or suggests a potential material
liability for either Party to Third Parties arising in
connection with any Program Product, or (c) which is
reasonably likely to lead to a recall or market withdrawal of
any Program Product, provided that neither Party shall be
obliged to disclose information in breach of any contractual
restriction which it could not reasonably have avoided.
Information that shall be disclosed pursuant to this Section
4.3.4 shall include, but not be limited to:
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(i) governmental or regulatory inspections of manufacturing,
distribution or other related facilities used for
Compounds or Program Products;
(ii) inquiries by governmental or regulatory authorities
concerning clinical investigation activities (including
inquiries of investigators, clinical monitoring
organizations and other related parties) relating to
Compounds or Program Products;
(iii) any communication from governmental or regulatory
authorities pertaining to the manufacture, sale,
promotion or distribution of Compounds or Program
Products;
(iv) any other governmental or regulatory authority reviews
or inquiries relating to Compounds or Program Products;
(v) receipt of a warning letter relating to any of the
Compounds or Program Products; and
(vi) an initiation of any governmental or regulatory
authority investigation, detention, seizure or
injunction concerning any Compound or Program Product.
ARTICLE 5
COMMERCIALIZATION PROGRAM
5.1 COMMERCIALIZATION RIGHTS.
5.1.1 Anadys will have exclusive commercialization rights in the Anadys
Territory.
5.1.2 LGLS will have exclusive commercialization rights in the LGLS
Territory.
5.2 MILESTONE PAYMENTS.
5.2.1 As partial consideration for the exclusive rights granted, Anadys
will make non-refundable milestone payments to LGLS as set forth
below. The milestone payments will be [...***...].
MILESTONES PAYMENTS [US$]
---------- --------------
Within 30 days of execution of License Agreement $4,000,000
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...]
[...***...]
[...***...]
[...***...]
[...***...]
[...***...]
***Confidential Treatment Requested
17
Total Milestone payments: $29,500,000
5.2.2 Anadys agrees to use commercially reasonable best efforts to achieve
the milestones set forth in Section 5.2.1 hereof in [...***...] and
to [...***...] sufficient for such purposes.
5.2.3 In addition to the quarterly reporting requirements set forth in
Section 5.3.4 hereof, until such time as all of the milestones based
on cumulative Net Sales of Program Products in the Anadys Territory
set forth in Section 5.2.1 hereof are satisfied, with such quarterly
reports after the First Commercial Sale of a Program Product in the
Anadys Territory, Anadys shall submit to LGLS a report providing the
cumulative Net Sales of Program Products in the Anadys Territory as
of such quarter end, which such report shall be accompanied or
preceded by payment of any such milestone payment then due but
unpaid.
5.3 ROYALTIES.
5.3.1 ON PROGRAM PRODUCTS SOLD IN ANADYS TERRITORY.
(a) Anadys shall pay to LGLS royalties on Net Sales of each
Program Product by Anadys or its sublicensees in countries in
the Anadys Territory as follows and except as otherwise
provided in Section 5.3.3 hereof:
ANNUAL NET SALES THRESHOLDS IN THE ANADYS TERRITORY ROYALTY
-------
([...***...])
[...***...] [...***...]%
[...***...] [...***...]%
Royalties on Net Sales of each Program Product in a calendar
year shall be paid at the rate applicable to the portion of
Net Sales within each of the Net Sales levels set forth in the
table above during such calendar year and without regard to
the country in which Net Sales occur. For example, if Net
Sales of Program Product in a given calendar year in all
countries in the Anadys Territory are [...***...] then the
royalty rate for the first [...***...] of such Net Sales would
be [...***...] million under this example), and the royalty
rate for such Net Sales in excess of [...***...] would be
[...***...] under this example), for a total royalty payment
under this example of [...***...].
5.3.2 ON PROGRAM PRODUCTS SOLD IN CHINA.
(a) LGLS shall pay to Anadys royalties on Net Sales of each
Program Product by LGLS or its sublicensees in China equal to
[...***...]% of such Net Sales, and except as otherwise
provided in Section 5.3.3 hereof.
5.3.3 BASIS FOR PAYING ROYALTIES.
(a) The [...***...] upon [...***...] of [...***...] to the other
[...***...] this [...***...] shall be [...***...] on a
[...***...] and [...***...] for a [...***...] beginning upon
the [...***...] of each [...***...] in the [...***...] and
[...***...] on the [...***...] of [...***...] of this
[...***...] with [...***...] to such [...***...] in such
[...***...] in [...***...] with [...***...] of this
[...***...]. During the [...***...] for a [...***...] for a
[...***...], the [...***...] on [...***...] of such
[...***...] in such [...***...] of the [...***...] under
[...***...] or [...***...], as applicable, for so long as
there is a [...***...] of an [...***...] within the
[...***...] claiming the manufacture, use or sale of the
[...***...] in such [...***...] or [...***...] in such
[...***...] of the [...***...] under [...***...] or
[...***...], as applicable, for any [...***...] that
[...***...] applies, or [...***...], as applicable, for any
[...***...] that [...***...] and [...***...] are [...***...]
in [...***...].
***Confidential Treatment Requested
18
(b) To the extent that any withholding tax is required to be
deducted from the payment of any milestone payment by Anadys
to LGLS under Section 5.2.1 or any royalty payment by one
Party to the other Party under Section 5.3.1 or 5.3.2, as
applicable, then such party will (a) deduct such taxes from
the remitting payment, (b) timely pay the taxes to the proper
taxing authority, and (c) send proof of payment to the other
party and certify its receipt by the taxing authority;
provided, however, that no such deduction shall be made in
respect of any portion of any royalty payment attributable to
Net Sales of Program Products by any sublicencee of a Party.
5.3.4 ROYALTY REPORTS; PAYMENTS. Within [...***...] ([...***...]) days
after the end of each calendar quarter in which a Party is the
Royalty-Paying Party with respect to Net Sales subject to any of the
provisions of Section 5.3.1, 5.3.2 or 5.3.3, as applicable, such
Party shall submit to the other Party a report, on the basis of each
product and country, providing in reasonable detail an accounting of
all Net Sales made during such calendar quarter and the calculation
of the applicable royalty under Section 5.3.1, 5.3.2 or 5.3.3, as
applicable. Concurrently with such report, the Royalty-Paying Party
submitting the report shall pay to the other Party all royalties
payable by it under Section 5.3.1, 5.3.2 or 5.3.3, as applicable, as
indicated in the report.
5.3.5 AUDITS. Each Party shall keep complete and accurate records of the
underlying revenue and expense data relating to the reports and
payments required by Sections 5.3.1, 5.3.2 or 5.3.3, as applicable,
and Section 5.3.4. Each Party will have the right once annually at
its own expense to have an independent, certified public accountant,
selected by such Party and reasonably acceptable to the other Party,
review any such records of the other Party in the location(s) where
such records are maintained by the other Party upon reasonable
notice and during regular business hours and under obligations of
strict confidence, for the sole purpose of verifying the basis and
accuracy of such payments, in each case within [...***...]
([...***...])[...***...] period. If the review of such records
reveals that the other Party has failed to accurately report
information pursuant to Section 5.3.4, then the other Party shall
promptly pay to the auditing Party any resulting amounts due under
Sections 5.3.1, 5.3.2 or 5.3.3, as applicable, and Section 5.3.4,
together with interest calculated in the manner provided in Section
5.3.7. If any amounts due under Section 5.3.1, Section 5.3.2 or
5.3.3, as applicable, as a result of such audit are greater than
[...***...] ([...***...]) of the amounts actually due for a calendar
year under Section 5.3.1, Section 5.3.2 or 5.3.3., as applicable,
the other Party shall pay all of the costs of such review. If a
Party in good faith disputes any conclusion of the accounting firm
under this Section 5.3.5, including that such Party owes additional
amounts, then such Party shall inform the other Party by written
notice within [...***...] ([...***...]) days of receipt of a copy of
the audit in question, specifying in detail such dispute. The
Parties shall promptly thereafter meet and negotiate in good faith a
resolution to such dispute. In the event that the Parties are unable
to resolve such dispute within [...***...] ([...***...]) days after
notice by the disputing Party, the matter shall be resolved in a
manner consistent with the procedures set forth in Section 5.6.4
(provided, that, in the case that the matter has not been resolved
by the CEOs of the Parties in accordance therewith, such matter
shall be referred to an internationally recognized independent
accounting firm acceptable to both Parties which shall arbitrate
such matter and interest shall be payable on any additional amounts
determined to be due in the same manner as provided for in Section
5.3.7.
5.3.6 CURRENCY EXCHANGE. With respect to Net Sales invoiced or expenses
incurred in U.S. dollars, the Net Sales or expense amounts and the
amounts due to the receiving Party hereunder shall be expressed in
U.S. dollars. With respect to Net Sales invoiced or expenses
incurred in a currency other than U.S. dollars, the Net Sales or
expense shall be expressed in the domestic currency of the entity
making the sale or incurring the expense, together with the U.S.
dollar equivalent, calculated using the arithmetic average of the
spot rates on the last business day of each month of the calendar
quarter in which the Net Sales were made or the expense was
incurred. The "closing mid-point rates" found in the "dollar spot
forward against the dollar" table published by THE FINANCIAL TIMES
or any other publication as agreed to by the Parties shall be used
as the source of spot rates to calculate the average as defined in
the preceding sentence. All payments shall be made in U.S. dollars.
If at any time legal restrictions in any country in any Territory
prevent the prompt remittance of any payments with respect to sales
in that country, the paying Party shall have the right and option to
make such payments by depositing the amount thereof in local
currency to the receiving Party's account in a bank or depository in
such country.
***Confidential Treatment Requested
19
5.3.7 LATE PAYMENTS. The paying Party shall pay interest in the nature of
a penalty to the receiving Party on the aggregate amount of any
payments that are not paid on or before the date such payments are
due under this Agreement at a rate per annum equal to the lesser of
the prime rate of interest plus [...***...] ([...***...]%), as
reported by THE WALL STREET JOURNAL, or the highest rate permitted
by applicable law, calculated on the number of days such payments
are paid after the date such payments are due.
5.4 COMMERCIAL SUPPLY.
5.4.1 [...***...], at its election, has the right [...***...] and
[...***...] to [...***...] for [...***...] at a [...***...] a
[...***...] to be [...***...], and, upon such election by
[...***...], the Parties shall negotiate a definitive commercial
supply agreement containing customary and reasonable terms and
conditions relating to such manufacture and supply.
5.5 COMMERCIALIZATION OF PROGRAM PRODUCTS.
5.5.1 Anadys will have the exclusive right to Commercialize Program
Products in the Anadys Territory.
5.5.2 LGLS will have the exclusive right to Commercialize Program Products
in the LGLS Territory.
5.6 JOINT STEERING COMMITTEE.
5.6.1 FORMATION AND MEMBERSHIP. Promptly after the Effective Date, but not
later than [...***...] ([...***...]) days after the Effective Date,
Anadys and LGLS shall establish a Joint Steering Committee (the
"Joint Steering Committee") comprised of [...***...] ([...***...])
representatives designated by Anadys and [...***...] ([...***...])
representatives designated by LGLS, with the right of each party to
designate successive substitutes for its representatives. The Joint
Steering Committee shall be chaired by [...***...].
5.6.2 RESPONSIBILITY. The Joint Steering Committee shall have overall
responsibility for managing, directing, overseeing and implementing
the collaboration between the Parties contemplated by this
Agreement, but shall not have any power to amend, modify or waive
compliance with the terms of this Agreement. The Joint Steering
Committee shall be responsible for, among other things:
(a) Approving the Global Development Plan Budget and any
amendments to the Global Development Plan or Global
Development Plan Budget following approval thereof by the
Joint Development Committee in accordance with Section 2.2.4;
(b) providing a forum for consensual decision making relating to
the collaboration of the Parties contemplated by this
Agreement; and
(c) monitoring the Parties' compliance with their respective
obligations under this Agreement.
5.6.3 ADMINISTRATIVE MATTERS. The chairs of the Joint Steering Committee
shall be responsible for calling meetings of the Joint Steering
Committee to be held in accordance with Section 5.6.5 hereof, for
distributing a proposed agenda in advance of each meeting called by
such chairs, and for leading such meetings. At each meeting of the
Joint Steering Committee, a Joint Steering Committee member
appointed by the chairs shall serve as secretary of that meeting and
shall record the minutes of such meeting. Such minutes shall provide
a description in reasonable detail of the discussions had at the
meeting and a list of any actions, decisions or determinations
approved by the Joint Steering Committee. The secretary of each
meeting shall distribute to all members of the Joint Steering
Committee such minutes within [...***...] ([...***...]) weeks after
such meeting At such next meeting, the Joint Steering Committee
shall approve or disapprove of such minutes, and such minutes shall
be revised as necessary for further review and approval or
disapproval by the Joint Steering Committee. Final minutes of each
meeting shall be distributed to the
***Confidential Treatment Requested
20
members of the Joint Steering Committee by the member of the Joint
Steering Committee who served as secretary at such meeting or such
member's replacement, if any.
5.6.4 DECISION MAKING. The Joint Steering Committee will attempt in good
faith to make decisions by [...***...] with respect to any matters
that properly come before it. If the Joint Steering Committee cannot
[...***...], the Joint Steering Committee shall refer such matter to
the CEOs of LGLS and Anadys to attempt in good faith to reach a
mutually agreeable decision. If the CEOs cannot reach consensus on
the matter within [...***...] ([...***...]) days from the day the
matter is so submitted to them, then the [...***...] in accordance
with [...***...].
5.6.5 MEETINGS.
(a) The Joint Steering Committee shall meet at least [...***...]
([...***...]) times per year following its formation during
the term of the License Agreement. Such meetings shall be held
at such times and places as are mutually agreed upon by the
Joint Steering Committee, with at least [...***...]
([...***...]) [...***...] per year to be conducted in person;
and at meetings not designated as being conducted in person,
the representatives may participate by means of conference
telephone or similar communications equipment by means of
which all persons participating in the meeting can hear each
other.
(b) Each Party shall use commercially reasonable efforts to cause
its representatives to attend the meetings of the Joint
Steering Committee in person. If a representative of a Party
is unable to attend a meeting, such Party may designate an
alternate representative to attend such meeting in place of
the absent representative. In addition, each Party may, at its
discretion, invite additional employees, and, with the consent
of the other Party, consultants or scientific advisors, to
attend the meetings of the Joint Steering Committee.
(c) Either Party may also convene a special meeting of the Joint
Steering Committee for the purpose of resolving disputes or
for the purpose of reviewing (or making) a decision pertaining
to the Global Development Plan by providing [...***...]
([...***...]) Business Days written notice to the other Party.
ARTICLE 6
INTELLECTUAL PROPERTY PROTECTION AND RELATED MATTERS
6.1 PROSECUTION OF APPLICATIONS AND MAINTENANCE ADMINISTRATION
6.1.1 ADMINISTRATIVE RESPONSIBILITY. [...***...] for [...***...] and
[...***...] of all [...***...] in the [...***...] the [...***...].
[...***...] of this [...***...] the [...***...] includes [...***...]
without limitation [...***...] includes, without limitation, the
[...***...].
6.1.2 CONSULTATION; ABANDONMENT. Regarding the [...***...] and [...***...]
of the [...***...] in [...***...] within the [...***...], including,
[...***...] the [...***...] of [...***...] and [...***...] and
[...***...], [...***...] and [...***...],[...***...] and [...***...]
to, [...***...] or in the [...***...] in [...***...],[...***...]
will [...***...] with [...***...] and [...***...] in [...***...],
will [...***...] the [...***...] to [...***...] in [...***...] on
[...***...] of [...***...], and will [...***...] from any
[...***...]. Any such [...***...] on which [...***...] and
[...***...],[...***...] be [...***...] to the [...***...] of
[...***...] and [...***...]. [...***...] the [...***...] any
[...***...] on [...***...] are [...***...] a [...***...].
[...***...] to [...***...] any [...***...] or [...***...] in the
[...***...],[...***...] in the [...***...] of [...***...] to be
[...***...] or are [...***...]or [...***...] the
[...***...],[...***...] thereof to [...***...], and, [...***...],
[...***...] and/or [...***...] of [...***...] all [...***...] and/or
[...***...] and [...***...] that the [...***...]. Upon [...***...]
to so [...***...] of the [...***...], may [...***...] all of
[...***...].
6.1.3 INVENTIONS. Except as provided in Section 6.1.4, ownership of
Inventions conceived of or reduced to practice in the course of the
Joint Development Program shall be determined in accordance with the
rules
***Confidential Treatment Requested
21
of inventorship under United States patent laws. Anadys shall own
all Anadys Inventions and all patent applications and patents
claiming Anadys Inventions. LGLS shall own all LGLS Inventions and
all patent applications and patents claiming LGLS Inventions.
6.1.4 JOINT INVENTIONS. The Parties acknowledge that during the term of
the Option Agreement and the License Agreement one or more
employees, agents or contractors of one party jointly with one or
more employees, agents or contractors of the other party may have
conceived and/or reduced to practice or may conceive and/or reduce
to practice one or more inventions that are necessary or useful for
the Development or Commercialization of any Compound or Product
(such inventions being "Joint Inventions"). [...***...]; provided,
however, that to the extent that in [...***...] in order to preserve
the patentability of any other [...***...], the Joint Development
Committee in accordance with the provisions of Section 2.2.4,
subject to the approval of the Joint Steering Committee in
accordance with the provisions of Section 5.6.4, shall determine
which Party shall thereafter have ownership of such Joint Patent
Rights and primary responsibility for preparing any patent
applications in respect of such Joint Inventions, prosecuting such
applications, and maintaining any Patents issued in respect of such
applications. To the extent that the Joint Development Committee
determines that [...***...] thereupon and thereafter be responsible
for the prosecution and maintenance of all patents and patent
application included in such assigned Joint Patent Rights to the
same extent as [...***...] is responsible under Section 6.1.1 for
patents and patent applications included in the [...***...]. The
provisions of Sections 6.2, 6.3 and 6.4 shall apply to such assigned
Joint Patent Rights, and the license granted by [...***...] Section
[...***...] of this Agreement shall include such assigned Joint
Patent Rights in order for [...***...] to exploit such assigned
Joint Patent Rights in the [...***...], and in respect of Program
Products that are Covered by such assigned Joint Patent Rights,
[...***...] shall pay royalties to [...***...] for Net Sales by
[...***...] or its sublicensees in [...***...] at the [...***...] in
Section [...***...], and otherwise such license to [...***...] of
such assigned Joint Patent Rights shall be royalty-free. For the
avoidance of doubt, the royalty on Net Sales of any Program Product
in [...***...] that is Covered by any such assigned Joint Patent
Rights and/or [...***...] shall be [...***...].
6.1.5 PROSECUTION AND MAINTENANCE EXPENSES.
(a) [...***...] to prosecution and maintenance of patents and
patent applications comprising the LGLS Patent Rights and
patents and patent applications claiming any joint inventions
or such other inventions referred to in Section 6.1.3 in
nations [...***...], provided that LGLS shall to the extent
practical prior to taking any such actions relating to such
prosecution or maintenance consult in good faith with Anadys's
patent counsel; and further provided, however, that
[...***...] in respect of such portion of the patents and
patent applications that do not or are not likely to contain
claims that Cover any Program Products. For purposes of this
Section 6.1.5, the parties agree to consult with each other in
good faith to determine an agreed upon patent strategy and
allocation of costs under the LGLS Patent Rights
(b) [...***...]relating to prosecution and maintenance of patents
and patent applications comprising the LGLS Patent Rights and
patents and patent applications claiming any joint inventions
or such other inventions referred to in Section 6.1.3 in
nations [...***...]
6.2 ENFORCEMENT
6.2.1 NOTICES. Each party will be responsible for promptly notifying the
other party of any information that comes to its attention relating
to infringing or possibly infringing activities by third parties
with respect to the LGLS Patent Rights or Joint Patent Rights upon
learning of such information, without regard to whether the nation
in which such activities have occurred is in that party's territory
or not.
6.2.2 IN ANADYS TERRITORY. In nations within the Anadys Territory
[...***...]
(a) if [...***...], except that if [...***...] in such [...***...]
in accordance with Section [...***...], then [...***...] will
[...***...] the [...***...] and [...***...] as a [...***...]
of such [...***...] as [...***...] of a [...***...], and
***Confidential Treatment Requested
22
(b) if [...***...], then
(i) [...***...] may bring the action, [...***...]; and
(ii) [...***...] shall bear the expense of such action and
shall be entitled to the full amount of any recovery. If
after receipt of any recovery, [...***...], and the
result of the action is a declaration of validity or
other confirmation of the scope of the patent asserted
by LGLS, [...***...]
6.2.3 PRIMARY RESPONSIBILITY. The Party in whose Territory the infringing
activities are or allegedly are occurring shall have primary
responsibility for bringing an action for infringement of the LGLS
Patent Rights or Joint Patent Rights (and any related interference
proceeding or opposition proceeding with respect to the LGLS Patent
Rights or Joint Patent Rights), but shall not be obligated to do so.
If the party with such primary responsibility is Anadys, LGLS may
join the action. If one Party elects to take action against such
infringement or alleged infringement or if the Parties agree to take
such action together, each Party will provide all reasonable
assistance to the enforcing Party in connection with any such
action, including being named as a Party to such action or
furnishing of a power of attorney to the enforcing Party, if
necessary to bring such action.
6.2.4 SETTLEMENTS. Neither Party shall have the right to settle any
infringement action with respect to the LGLS Patent Rights or Joint
Patent Rights in the Anadys Territory in a manner that would
diminish the rights or interests of the other party or obligate the
other party to make any payment or take any action without the prior
written consent of such other Party.
6.3 DEFENSE.
6.3.1 NOTICES. Each Party will be responsible for notifying the other
Party of any claim or threatened claim by a Third Party alleging
infringement by a Program Product, or of any declaratory judgment
action or opposition asserting the invalidity or unenforceability of
a licensed LGLS Patent Right, or that a licensed LGLS Patent Right
is subject to an interference, inter parte reexamination or an
opposition proceeding instituted by a Third Party without regard to
whether the nation in which such activities have occurred is in that
Party's Territory or not.
6.3.2 IN ANADYS TERRITORY. In nations within the Anadys Territory,
(a) the [...***...] against such claim or threatened claim, action
or proceeding;
(b) if named as a defendant in any action alleging any such claim,
each Party shall have the right to defend against such claim
at its own expense, subject to any indemnity from the other
Party provided under the indemnity provisions set forth in
Article 8 of this Agreement. If the claim is brought within
the Anadys Territory and LGLS is not named as a defendant,
LGLS may join in the defense of such claim [...***...]; and
(c) any awards resulting from counterclaims shall be shared by
Anadys and LGLS in proportion to the expenses borne by each
Party.
6.3.3 SETTLEMENTS. Neither Party shall have the right to settle any action
described in this Section 6.3 in the Anadys Territory in a manner
that would diminish the rights or interests of the other party or
obligate the other Party to make any payment or take any action
without the prior written consent of such other Party.
6.4 COOPERATION.
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23
6.4.1 EMPLOYEES. Each Party hereby agrees to make its employees, agents
and consultants reasonably available to the other Party (or to the
other Party's authorized attorneys, agents or representatives), to
the extent reasonably necessary to give effect to Sections 6.1, 6.2
and 6.3 of this Agreement.
6.4.2 MATERIALS. Each Party hereby agrees to provide the other Party with
copies of all material correspondence pertaining to the LGLS Patent
Rights and Joint Patent Rights to the extent reasonably necessary to
give effect to Sections 6.1, 6.2 and 6.3 of this Agreement.
6.4.3 OTHER COOPERATION. Each Party hereby agrees to cooperate to the
extent reasonably necessary to give effect to Sections 6.1, 6.2 and
6.3 of this Agreement and, where necessary or advisable, to obtain
patent term extensions of the LGLS Patent Rights and patent rights
in Joint Inventions.
6.4.4 COORDINATION. Each Party hereby agrees to endeavor in good faith to
coordinate its efforts with the other Party to give effect to
Sections 6.1, 6.2, 6.3 and other sections of this Section 6.4.
6.5 MARKS FOR PROGRAM PRODUCTS.
6.5.1 PATENT MARKS. Each Party shall ▇▇▇▇ all Program Products or their
containers in accordance with all applicable patent-marking laws.
6.5.2 TRADE MARKS AND THE LIKE. The Joint Steering Committee shall
mutually agree upon trade ▇▇▇▇, trade names, service marks and the
like for any Program Product reasonably prior to Commercialization
of such Program Product.
ARTICLE 7
REPRESENTATIONS, WARRANTIES AND COVENANTS
7.1 CORPORATE POWER. Each Party hereby represents and warrants that it is duly
organized, validly existing and in good standing under the laws of the state or
country of its incorporation and has full corporate power and authority to enter
into this Agreement and to carry out the provisions hereof.
7.2 DUE AUTHORIZATION. Each Party hereby represents and warrants that such
Party is duly authorized to execute and deliver this Agreement and to perform
its obligations hereunder.
7.3 BINDING AGREEMENT. Each Party hereby represents and warrants that this
Agreement is a legal and valid obligation binding upon it and is enforceable in
accordance with its terms. The execution, delivery and performance of this
Agreement by such Party does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any law or regulation of any court, governmental body or
administrative or other agency having authority over it.
7.4 NO CONFLICT. Each Party represents and warrants that it is not presently
bound by any agreement with any Third Party materially limiting such Party's
performance of any of the obligations or activities provided for under this
Agreement, and that such Party is not aware of any patents, patent applications
and/or know-how that such Party does not Control (in the case of Anadys, after
giving effect to this Agreement) that is necessary for the Development or the
Commercialization of the Compounds as contemplated by this Agreement. Each party
covenants that it will not take any action or fail to take any action that will
materially limit its performance under this Agreement. In particular, but
without limiting the foregoing, each Party covenants that it will not take any
action or fail to take any action that may limit or interfere with the rights
granted by such Party to the other Party under this Agreement.
7.5 OWNERSHIP OF PATENT RIGHTS. LGLS represents and warrants that (a) it is
the sole owner of all right, title and interest in and to the LGLS Patent Rights
and it Controls the LGLS Know-How, (b) it has not granted any license under the
LGLS Patent Rights to any Third Party and is under no obligation to grant any
such license, except to Anadys, and (c) there are no outstanding liens,
encumbrances, agreements or understandings of any kind, either written, oral or
implied, regarding the LGLS Patent Rights or the LGLS Know-How which are
materially inconsistent or are materially in conflict with this Agreement.
24
7.6 [...***...]
7.7 DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE OTHER PARTY OF ANY
KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
7.8 LIMITATION OF LIABILITY. EXCEPT FOR [...***...], AND LIABILITY FOR
[...***...] OR FOR [...***...], NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM
THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN
CONNECTION WITH THE [...***...] HEREUNDER.
ARTICLE 8
INDEMNIFICATION
8.1 INDEMNIFICATION BY ANADYS.
8.1.1 GENERALLY. Anadys hereby agrees to save, defend, indemnify and hold
harmless LGLS and its directors, officers, employees and agents
(each an "LGLS Indemnitee" and collectively, the "LGLS Indemnitees")
from and against any and all liabilities, expenses and losses,
including reasonable legal expense and attorneys' fees ("Losses"),
as incurred, arising directly or indirectly out of the breach of any
representation, warranty or covenant made by Anadys hereunder,
except to the extent such Losses result from the negligence or
willful misconduct of LGLS (provided that if such [...***...] in
part by the [...***...] or [...***...] of [...***...], or (ii) any
claims brought by any Third Party as a holder of securities issued
by Anadys in their capacity as such.
8.1.2 NOTICES; DEFENSE. In the event any LGLS Indemnitee seeks
indemnification under this Section 8.1, such LGLS Indemnitee shall
inform Anadys of a claim as soon as reasonably practicable after
such LGLS Indemnitee receives notice of the claim, shall permit
Anadys to assume direction and control of the defense of the claim
(including the right to settle the claim solely for monetary
consideration), and shall cooperate as requested (at the expense of
Anadys) in the defense of the claim; provided that such LGLS
Indemnitee shall have the right to employ separate legal counsel in
any such action and participate in the defense thereof, but the fees
and expenses of such legal counsel shall be at the expense of such
LGLS Indemnitee unless (i) the employment of such legal counsel
shall have been specifically authorized in writing by Anadys, (ii)
Anadys shall have failed to assume the defense and employ legal
counsel or (iii) the named persons to any such action (including any
third persons to the action) include both Anadys and such LGLS
Indemnitee and such LGLS Indemnitee shall have been advised that
there may be one or more legal defenses available to such LGLS
Indemnitee that are different from or additional to those available
to Anadys (in which case Anadys shall not have the right to assume
the defense on behalf of such LGLS Indemnitee). Anadys shall not
bear the fees and expenses of more than one (1) legal counsel for
LGLS Indemnitees pursuant to the immediately preceding sentence.
8.1.3 SETTLEMENTS. Anadys shall not be liable for any settlement of any
such action effected by any LGLS Indemnitee without Anadys's written
consent but, if settled with the written consent of Anadys, Anydys
agrees to indemnify and hold harmless such LGLS Indemnitee from and
against any loss or liability by reason of such settlement. With
respect to any pending or threatened proceeding in respect of which
any LGLS Indemnitee is or could have been a party and indemnity
could have been sought hereunder by such LGLS Indemnitee, Anadys
shall not effect any settlement of such proceeding without the prior
written consent of such LGLS Indemnitee, unless such settlement
includes an unconditional release of such LGLS Indemnitee from all
liability on claims that are the subject matter of such proceeding.
8.2 INDEMNIFICATION BY LGLS.
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8.2.1 GENERALLY. LGLS hereby agrees to save, defend, indemnify and hold
harmless Anadys and its directors, officers, employees and agents
(each an "Anadys Indemnitee" and collectively, the "Anadys
Indemnitees") from and against any and all Losses arising directly
or indirectly out of the breach of any representation, warranty or
covenant made by LGLS hereunder, except to the extent such
[...***...] from the [...***...] or [...***...] of [...***...], then
this [...***...] to that [...***...] [...***...].
8.2.2 NOTICES; DEFENSE. In the event any Anadys Indemnitee seeks
indemnification under this Section 8.2, such Anadys Indemnitee shall
inform LGLS of a claim as soon as reasonably practicable after such
Anadys Indemnitee receives notice of the claim, shall permit LGLS to
assume direction and control of the defense of the claim (including
the right to settle the claim solely for monetary consideration),
and shall cooperate as requested (at the expense of LGLS) in the
defense of the claim; provided that such Anadys Indemnitee shall
have the right to employ separate legal counsel in any such action
and participate in the defense thereof, but the fees and expenses of
such legal counsel shall be at the expense of such Anadys Indemnitee
unless (i) the employment of such legal counsel shall have been
specifically authorized in writing by LGLS, (ii) LGLS shall have
failed to assume the defense and employ legal counsel or (iii) the
named persons to any such action (including any third persons to the
action) include both LGLS and such Anadys Indemnitee and such Anadys
Indemnitee shall have been advised that there may be one or more
legal defenses available to such Anadys Indemnitee that are
different from or additional to those available to LGLS (in which
case LGLS shall not have the right to assume the defense on behalf
of such Anadys Indemnitee). LGLS shall not bear the fees and
expenses of more than one (1) legal counsel for Anadys Indemnitees
pursuant to the immediately preceding sentence.
8.2.3 SETTLEMENTS. LGLS shall not be liable for any settlement of any such
action effected by any Anadys Indemnitee without LGLS's written
consent but, if settled with the written consent of LGLS, LGLS
agrees to indemnify and hold harmless the Anadys Indemnitee from and
against any loss or liability by reason of such settlement. With
respect to any pending or threatened proceeding in respect of which
any Anadys Indemnitee is or could have been a party and indemnity
could have been sought hereunder by such Anadys Indemnitee, LGLS
shall not effect any settlement of such proceeding without the prior
written consent of such Anadys Indemnitee, unless such settlement
includes an unconditional release of such Anadys Indemnitee from all
liability on claims that are the subject matter of such proceeding.
ARTICLE 9
CONFIDENTIALITY
9.1 GENERAL RULE. Each Party agrees that during the period specified in
Section 9.3 of this Agreement such Party will hold in confidence and not
disclose Confidential Information to any Third Party, except as approved in
writing by the original disclosing Party and provided that such Third Party is
under at least as stringent conditions of confidentiality and limitations on use
as set forth in this Agreement. The receiving Party further agrees that it shall
limit dissemination of and access to the Confidential Information to those
employees and consultants of the receiving Party who have a need to know the
Confidential Information for the Joint Development Program and who are under at
least as stringent conditions of confidentiality and limitations on use as set
forth in this Agreement.
9.2 EXCLUSIONS. Each Party's obligations under this Agreement with respect to
any portion of the Confidential Information shall terminate with respect to such
portion of the Confidential Information when the receiving party can document
that: (a) it was in the public domain at the time it was communicated to the
receiving Party; (b) it entered the public domain subsequent to the time it was
communicated to the receiving Party through no fault of the receiving Party; (c)
it was in the receiving Party's possession free of any obligation of confidence
at the time it was communicated to the receiving Party; (d) it was rightfully
communicated to the receiving Party by a Third Party free of any obligation of
confidence subsequent to the time it was communicated to the receiving Party by
the disclosing Party; or (e) it is required by law, regulation rule, act or
order of any governmental authority to be disclosed, provided that the original
receiving Party gives the original disclosing Party timely, prior notification
in order to give
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the original disclosing Party an opportunity to take appropriate action to limit
or prevent disclosure of such Confidential Information.
9.3 SURVIVAL. The provisions of this Article 9 shall survive until the later
of (a) the termination of this Agreement pursuant to Section 10.1 of this
Agreement and (b) [...***...] ([...***...]) years following the termination of
this Agreement pursuant to Section 10.2 of this Agreement.
9.4 GOVERNMENTAL FILINGS. To the extent that this Agreement (including the
exhibit attached hereto), the Option Agreement (including the exhibit attached
thereto), or any other Confidential Information of LGLS must be described in, or
attached to or filed with any governmental agency as an exhibit to or part of,
any registration statement, prospectus, private placement memorandum, securities
purchase agreement, term sheet, application or like instrument relating to the
sale of securities by Anadys or for any other purpose, then the content of such
description and any amendment or revision thereof shall be subject to the prior
written approval of LGLS which shall not be unreasonably withheld or delayed,
and, to the extent that Anadys has the right to apply to any governmental agency
for confidential, non-public treatment of the contents of this Agreement
(including the exhibit attached hereto), the Option Agreement (including the
exhibit attached thereto), or any other Confidential Information of LGLS shall
have the right to reasonably request of Anadys those portions thereof for which
Anadys shall seek such confidential, non-public treatment, to promptly review
any such submission, application, memorandum, correspondence or the like to such
governmental agency seeking, or in support of, such confidential, non-public
treatment prior to the transmission thereof to such government agency, and
Anadys shall not agree to forego such confidential, non-public treatment of such
content so specified by LGLS without the prior written consent of LGLS, which
shall not be unreasonably withheld or delayed, unless Anadys is required by law
or regulation or by the requirements of such governmental agency, including,
without limitation, the United States Securities and Exchange Commission, to do
so, provided that LGLS shall be given reasonably prompt prior notice of any such
requirement so that LGLS shall have a reasonable opportunity to limit or
otherwise challenge such disclosure.
9.5 PUBLICATIONS; PUBLIC ANNOUNCEMENTS.
9.5.1 PUBLICATIONS. Neither Party nor any CRO, investigator the like under
contract with or the direction of such Party shall submit for
publication, publish or otherwise present any results of the Joint
Development Program or clinical studies on any Compound or Program
Product ("Program Results") except in accordance with this Section
9.5.1. Each Party shall provide to the other Party the opportunity
to review any such proposed abstracts, manuscripts or summaries of
presentations that cover Program Results, and such other Party shall
respond in writing to the requesting Party within [...***...]
([...***...]) days after receipt of the proposed material with
either approval of the submission, publication or other presentation
of the proposed material or approval of the submission, publication
or other presentation of the proposed material only after
satisfaction of certain specified conditions.
9.5.2 PUBLIC ANNOUNCEMENTS. Each Party agrees not to issue any press
releases or like announcement relating to this Agreement or
otherwise containing or relating to Confidential Information without
the express written consent of the other Party; provided that
announcements in the nature of government filings shall be subject
to Section 9.4 of this Agreement. Each Party seeking to issue any
such press release or like announcement shall provide the other
Party with an advance copy of any such press release or like
announcement at least [...***...] ([...***...]) business days prior
to the scheduled disclosure thereof, and such other Party shall have
the right to review and recommend changes to such press release or
like announcement. Except as otherwise required by law, the Party
seeking to issue any such press release or like announcement shall
remove any information that the other Party reasonably deems to be
inappropriate for disclosure. Notwithstanding the foregoing, the
parties hereby agree to issue a joint press release upon the
execution of this Agreement, the content of which shall be mutually
agreeable to the parties.
9.6 REPLACEMENT OF PRIOR AGREEMENT. The parties hereby agree that this Article
9 and related provisions of this Agreement replace and supercede in their
entirety that certain Confidentiality Agreement, dated February 17, 2004, by and
between LGLS and Anadys.
ARTICLE 10
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TERM; TERMINATION
10.1 TERM. This Agreement shall commence as of the Effective Date and shall
continue on a country-by-country and Program Product-by-Program Product basis in
each country in the Anadys Territory until the [...***...] of (i) the last to
expire of [...***...] in [...***...] and (ii) [...***...] ([...***...]) years
after the date of [...***...] of such Program Product in such country.
10.2 TERMINATION.
10.2.1 PRIOR TO EXPIRATION. Either party may terminate this Agreement
prior to the expiration of the term of this Agreement upon the
occurrence of any of the following:
(a) Upon or after the bankruptcy, insolvency, dissolution or
winding up of the other party (other than dissolution or
winding up for the purposes of reconstruction or
amalgamation); or
(b) Upon or after the breach of any material provision of this
Agreement by the other party if the breaching party has not
cured such breach within [...***...] [...***...] after written
notice thereof by the non-breaching party; provided, however,
that with respect to any such breach, if (A) the breaching
party has commenced actions to cure such breach prior to such
[...***...] [...***...] and is continuing in good faith to
pursue such cure at such [...***...][...***...] and (B)
[...***...] in the [...***...] of the non-breaching party that
such actions of the breaching party will [...***...] such
breach on or before the [...***...][...***...] after such
written notice, then this agreement [...***...] as a
consequence of such breach if such breach shall be [...***...]
on or before such [...***...][...***...] such written notice;
provided, however, the [...***...] of [...***...] to
[...***...] any [...***...] required [...***...] to
[...***...] under this Agreement shall constitute a material
breach of this Agreement that must be cured no later than
[...***...] ([...***...]) days following the due date of
such payment. For purposes of this clause (b), a Party shall
be deemed to have breached a material provision of this
Agreement if [...***...] such Party: fails to [...***...] and
[...***...] in the [...***...]; causes [...***...] in the
[...***...] fails to [...***...] in a [...***...]; or fails to
[...***...] for which such Party is responsible under the
Global Development Plan.
(c) For purposes of the last sentence of clause (b) of this
Section 10.2.1, there shall be deemed to be a [...***...] and
[...***...] in [...***...] with [...***...] to any [...***...]
and a [...***...] the [...***...] for which [...***...] is
responsible under the Global Development Plan with respect to
any [...***...] in the [...***...] in respect of which any of
the following events occurs, and in respect of [...***...] in
respect of which any of the following events occurs, this
Agreement shall thereupon [...***...]:
(i) with respect to each of the [...***...], [...***...] in
[...***...], and [...***...], there [...***...] of a
Program Product by the [...***...], as applicable,
[...***...] the [...***...] set forth in the Global
Development Plan for such [...***...], subject to any
[...***...] of [...***...] for [...***...] occurrences
[...***...] in [...***...] of [...***...] or
[...***...], provided however, [...***...] for which
[...***...] has not been set forth in the Global
Development Plan, the provision (iii) of this subsection
(c) shall apply to [...***...];
(ii) with respect to each of the [...***...] in [...***...],
and [...***...], there [...***...] of a Program Product
[...***...] following the occurrence of a [...***...]
for [...***...] for that [...***...]; [...***...]
(iii) with respect to [...***...] than the [...***...], any
[...***...] in [...***...] which the [...***...] has
[...***...] in the Global
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Development Plan, there [...***...] occurred [...***...]
and a [...***...] Program Product in such [...***...] by
the [...***...] of [...***...] of a Program Product
[...***...] any of the [...***...], the [...***...], the
[...***...] or [...***...] of the [...***...].
(d) The Parties agree that in the event of an [...***...] under
the License Agreement by [...***...] shall in [...***...] an
[...***...] of [...***...], in connection with which such
[...***...] the [...***...] may, [...***...] are not
[...***...], and if the [...***...] are [...***...] to
[...***...] upon any [...***...] of this Agreement, the
[...***...] be [...***...] in accordance with Section
[...***...].
(e) The Parties agree that any event [...***...] and [...***...]
to make [...***...] under this Agreement as to which there is
[...***...] as to such [...***...] and [...***...] of this
[...***...] pursuant to [...***...] Section [...***...] shall
be [...***...] and not subject to [...***...] in accordance
with Section [...***...] of this Agreement. For the sake of
clarity, any [...***...] in accordance with Section
[...***...].
10.2.2 EFFECT OF TERMINATION.
(a) Upon termination of this Agreement, all rights and obligations
of the parties hereunder shall terminate, except as provided
in this Section 10.2.2.
(b) Upon expiration of this Agreement or termination for any
reason whatsoever, [...***...] all [...***...] in the
[...***...] and [...***...] pursuant to this Agreement and
[...***...] the Global Development Plan, the Program
Technology, and the Program Materials, and any and [...***...]
to [...***...] under this Agreement [...***...], and
[...***...] in the [...***...] and [...***...] shall
[...***...]; provided, however, that in the case of expiration
of this Agreement under Section 10.1 of this Agreement, if
[...***...] to [...***...] any [...***...] in the [...***...],
Anadys, upon written notice to LGLS within [...***...]
([...***...]) days prior to such expiration, may after such
expiration continue to [...***...] and [...***...] to the
[...***...], [...***...] and [...***...], [...***...] shall
not otherwise have any obligations under this Agreement
with respect thereto.
(c) Expiration or termination of this Agreement shall not relieve
the parties of any obligation accruing prior to such
expiration or termination. The following provisions of this
Agreement shall survive termination or expiration of this
Agreement: Section [...***...]; Section [...***...]; Sections
[...***...]; Sections [...***...]; Section [...***...];
Section [...***...]; Article 9 (Confidential Information);
[...***...] Section [...***...]; and Sections [...***...],
[...***...], [...***...], [...***...], [...***...], 11.6
(headings, references), [...***...].
ARTICLE 11
MISCELLANEOUS
11.1 ASSIGNMENT. [...***...]. [...***...] this Agreement and its rights and
obligations hereunder [...***...] (a) [...***...] with the [...***...] or
[...***...] of [...***...] or [...***...] all of [...***...] relating to the
[...***...] of this [...***...] to [...***...], (b) in the event of [...***...]
or [...***...] of [...***...] with or into [...***...], or
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(c) to any [...***...] of [...***...]. Except as provided above, [...***...] may
not [...***...] or [...***...] this [...***...] or any [...***...] or
[...***...] hereunder without the [...***...] of [...***...],[...***...]. The
rights and obligations of the parties under this Agreement shall be binding upon
and inure to the benefit of the successors and permitted assigns of the parties.
Any assignment [...***...].
11.2 SEVERABILITY. In case any provisions of this Agreement shall be invalid,
illegal or unenforceable in any jurisdiction, the validity, legality and
enforceability of the remaining provisions shall not in any way be affected or
impaired thereby unless the invalid, illegal or unenforceable provisions are of
such essential importance to this Agreement that it is to be reasonably assumed
that the Parties would not have entered into this Agreement without such
invalid, illegal or unenforceable provisions, and in respect of such invalid,
illegal or unenforceable provisions the Parties shall substitute, by mutual
consent, valid provisions for such invalid, illegal or unenforceable provisions
which valid, legal and enforceable provisions in their economic effect are
sufficiently similar to the invalid, illegal or unenforceable provisions that it
can be reasonably assumed that the Parties would have entered into this
Agreement with such valid provisions.
11.3 NOTICES. Any notices or communications provided for in this Agreement to
be made by either of the parties to the other shall be in English in writing and
delivered personally or sent by registered or certified mail, postage paid, by
overnight delivery service such as FedEx or UPS or by facsimile, with
confirmation of receipt, addressed as follows:
IF TO ANADYS: Anadys Pharmaceuticals, Inc.
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: [...***...]
Fax No. [...***...]
IF TO LGLS: LG Life Sciences
[...***...]
▇▇, ▇▇▇▇▇-▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇-▇▇,
▇▇▇▇▇ ▇▇▇-▇▇▇, ▇▇▇▇▇
Attn: [...***...]
Fax No. [...***...]
Either party may by like notice specify or change an address to which notices
and communications shall thereafter be sent. Notices sent by facsimile shall be
effective upon confirmation of receipt, notices sent by mail or overnight
delivery service shall be effective upon receipt, and notices given personally
shall be effective when delivered.
11.4 GOVERNING LAW. This Agreement shall be governed by, and construed and
enforced in accordance with, the laws of the [...***...], without regard to its
choice of law provisions, and any applicable laws of the [...***...], except
matters of intellectual property law, which shall be determined in accordance
with the intellectual property laws relevant to the intellectual property in
question. Any disputes (except injunctive relief allowed by a court) arising out
of or in connection with this Agreement shall be finally resolved by Arbitration
in accordance with [...***...] by [...***...] selected in accordance with such
rules. [...***...]. [...***...],[...***...].
11.5 ENTIRE AGREEMENT; AMENDMENT. This Agreement (including the exhibit
attached hereto) sets forth all of the covenants, promises, agreements,
warranties, representations, conditions and understandings between the parties
hereto with respect to the subject matter hereof, and supersedes and terminates
all prior agreements and understanding between the parties with respect to the
subject matter hereof. There are no covenants, promises, agreements, warranties,
representations conditions or understandings with respect to the subject matter
hereof, either oral or written, between the parties other than as set forth
herein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the parties hereto unless reduced to writing and
signed by the respective authorized officers of the parties.
11.6 HEADINGS; REFERENCES. The captions or headings of the sections or other
subdivisions contained in this Agreement are not a part of this Agreement, but
are merely guides or labels to assist in locating and reading the
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several Articles hereof and shall have no effect on the meaning of the
provisions hereof. Unless otherwise specified to the contrary, references to
articles and sections in this Agreement shall be to the articles and sections
comprising this Agreement.
11.7 INDEPENDENT CONTRACTORS. It is expressly agreed that LGLS and Anadys shall
be independent contractors and that the relationship between the two parties
shall not constitute a partnership, joint venture or agency of any kind. Neither
party shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other, without the prior written consent of the other party. Members of the
Joint Development Committee, the Joint Steering Committee, and any subcommittees
thereof shall be, and shall remain, employees or other representatives of LGLS
or Anadys, as the case may be. No Party shall incur any liability for any act or
failure to act by members of the Joint Development Committee, any Joint
Development Project Team, and any subcommittees thereof who are employees or
other representatives of the other Party.
11.8 WAIVER. Except as specifically provided for herein, the waiver from time
to time by either of the parties of any of their rights or their failure or
delay to exercise any remedy, right, power or privilege under this Agreement or
provided by statute or at law or in equity or otherwise shall not operate or be
construed as a continuing waiver of the same remedies, rights, powers or
privileges or of any other of such party's remedies, rights, powers or
privileges provided in this Agreement, nor shall any single or partial exercise
of any such right, power, remedy or privilege preclude any other or further
exercise thereof or the exercise of any other right, power, remedy or privilege.
11.9 COMPLIANCE WITH EXPORT REGULATIONS. Neither Party shall export any
technology licensed to it by the other Party under this Agreement except in
compliance with applicable export laws and regulations.
11.10 COUNTERPARTS. This Agreement may be executed in two or more counterparts,
each of which when so executed and delivered shall be deemed an original, but
all of which together shall constitute one and the same instrument.
11.11 FORCE MAJEURE. No failure or omission by either Party in the performance
of any obligation of this Agreement shall be deemed a breach of this Agreement
or create any liability if the same shall arise from any cause or causes beyond
the control of such Party, including, but not limited to, the following:
[...***...].
11.12 NO STRICT CONSTRUCTION. This Agreement has been prepared jointly and
shall not be strictly construed against either Party.
11.13 NO THIRD PARTY BENEFICIARIES. No person or entity other than Anadys, LGLS
and their respective Affiliates and permitted assignees hereunder shall be
deemed an intended beneficiary hereunder or have any right to enforce any
obligation of this Agreement.
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first set forth above.
ANADYS PHARMACEUTICALS, INC. LG LIFE SCIENCES, LTD.
By: ________________________________ By: ______________________________
Name: Name:
Title: _______________________________ Title: _____________________________
32
EXHIBIT A
PATENT RIGHTS
Appl. No. Appl. date Grant No. Grant date Status
[...***...] [...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...] [...***...] [...***...] Enter
designated
state
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
Title country Appl. No. Appl. date Grant No. Grant date Status
[...***...] [...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
[...***...] [...***...] [...***...]
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AMENDMENT #1
TO JOINT DEVELOPMENT AND LICENSE AGREEMENT
BY AND BETWEEN LG LIFE SCIENCES, LTD.
AND ANADYS PHARMACEUTICALS, INC.
DATED APRIL 18, 2004
Effective as of June 16, 2004 (the "Amendment #1 Effective Date"), Anadys
Pharmaceuticals, Inc., a Delaware Corporation ("Anadys") and LG Life Sciences,
Ltd., a Korean corporation ("LGLS") enter into this Amendment #1 to the Joint
Development and License Agreement dated April 18, 2004 by and between Anadys and
LGLS (the "Joint Development Agreement").
1. Terms used herein with capital initial letters (or whole in capital
letters) and not otherwise defined herein shall have the same meanings as
set forth in the Joint Development Agreement.
2. The Joint Development Agreement is amended as set forth hereinafter:
a. Section 2.3.2 of the Joint Development Agreement is hereby amended
and restated in its entirety to read as follows:
"INITIAL ADOPTION. The Joint Development Committee shall prepare and
approve and the Joint Steering Committee shall approve in accordance
with Section 5.6.4 the initial version of the Global Development
Plan (including the details of the [...***...] Study and the details
of the [...***...] required for Regulatory Approval) within
[...***...] ([...***...])[...***...] following the Effective Date."
b. Section 3.3.3 of the Joint Development Agreement is hereby amended
and restated in its entirety to read as follows:
"[...***...]."
3. All other provisions of the Joint Development Agreement shall remain
unchanged and the Joint Development Agreement shall remain in full force
and effect.
IN WITNESS WHEREOF, the parties hereto have executed this Amendment #1 to
the Joint Development Agreement as of the Amendment #1 Effective Date.
ANADYS PHARMACEUTICALS, INC. LG LIFE SCIENCES LTD.
By:___________________________________ By:_________________________________
Name: ________________________________ Name:_______________________________
Title:________________________________ Title:______________________________
Address: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇ Address: ▇▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇ LG Twin Tower
▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇-▇▇
▇▇▇▇▇ ▇▇▇-▇▇▇, ▇▇▇▇▇
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