EXHIBIT 10.15
CERYLID PTY LTD
(ABN 92 061 632 684)
and
ANADYS PHARMACEUTICALS INC
SCREENING AGREEMENT
▇▇▇▇▇▇ ▇▇▇▇▇ Leibler
Ref: SGS:01- 1105573
TABLE OF CONTENTS
1 DEFINITIONS AND INTERPRETATION...................................... 1
2 FEES................................................................ 12
3 SUPPLY OF SAMPLE EXTRACTS........................................... 13
4 USE OF SAMPLE EXTRACTS.............................................. 13
5 SCREENS / TARGETS................................................... 13
6 SCREENING........................................................... 14
7 DEREPLICATION AND CHARACTERISATION.................................. 15
8 TERM................................................................ 16
9 REPORTING........................................................... 16
10 IDENTIFIED COMPOUNDS............................................. 16
11 EVALUATION COMPOUNDS............................................. 17
12 LICENCE OF SELECTED COMPOUNDS.................................... 18
13 INVENTIONS....................................................... 18
14 PRIOR RIGHTS..................................................... 21
15 MANAGEMENT COMMITTEE AND REPORTING............................... 22
16 TERMINATION...................................................... 23
17 DISPUTE RESOLUTION............................................... 24
18 CONFIDENTIAL INFORMATION......................................... 25
19 PUBLICITY........................................................ 27
20 REPRESENTATIONS AND WARRANTIES................................... 27
21 LIMITATION OF LIABILITY.......................................... 28
22 INDEMNITY........................................................ 29
23 UNCONTROLLABLE EVENTS............................................ 29
24 NOTICES.......................................................... 31
25 GENERAL PROVISIONS............................................... 32
26 GOVERNING LAW AND JURISDICTION................................... 34
*** 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), 200.83 AND 230.406.
SCREENING AGREEMENT
DATE
This Agreement is made on the date specified in Item 1 of Schedule 1.
PARTIES
This Agreement is made between the parties described in Item 2 of Schedule 1.
BACKGROUND
A. Cerylid has an extensive library of natural product extracts and
conducts screening of its library to identify compounds of possible
therapeutic interest.
B. Anadys wishes to receive samples from Cerylid's library and conduct
screens using those samples and to engage Cerylid to conduct
dereplication and characterisation of hits obtained by Anadys on the
terms of this Agreement.
AGREEMENT
1 DEFINITIONS AND INTERPRETATION
1.1 DEFINITIONS
In this Agreement:
"ACCESS FEE" means the amount specified in Item 3 of Schedule
1;
"AFFILIATE" means, in relation to a Party, any person,
organization, corporation or other entity controlled by,
controlling or under common control with that Party; For the
purposes of this definition, "control" means that an entity
owns, directly or indirectly, at least 50% of the voting
shares or other ownership interest of another entity, or has
the actual ability to control and direct the management of
another entity, whether by contract or otherwise;
"AGREEMENT" means this agreement;
"ANADYS" means Anadys Pharmaceuticals, Inc.;
"ANADYS INVENTIONS" means all:
(a) Inventions created or developed by or conceived of
and reduced to practice as part of the Screening
Activities solely by Anadys' employees and
contractors; and
(b) Targets and Screens,
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including, without limitation, Intellectual Property Rights
claiming Anadys Inventions specified in paragraph (a) or (b)
of this definition, but excluding Identified Compounds and
Evaluation Compounds arising during and out of the Screening
Activities;
"ANADYS PATENTS" means all patents and patent applications
claiming Anadys Inventions;
"ANADYS SCREENING DATA" means, with respect to each Screen
conducted by or on behalf of Anadys, data generated in the
conduct of that Screen regarding assay validation and assay
completion and information regarding the biological activity
of each of the ▇▇▇▇▇;
"ASSESSMENT PERIOD" means, in respect of an Identified
Compound, the period specified in Item 5 of Schedule 1
commencing on the date on which Cerylid provides to Anadys the
last of the items it is required to provide to Anadys pursuant
to clause 10.1;
"BUSINESS DAY" means a day on which banks are open for
business in Melbourne other than a Saturday, a Sunday or a
public holiday;
"CERYLID" means Cerylid Pty Limited;
"CERYLID GROUP" means Cerylid and each Related Body Corporate
of Cerylid;
"CERYLID INVENTIONS" means all:
(a) Inventions created or developed by or conceived of
and reduced to practice as part of the Screening
Activities solely by Cerylid's employees and
contractors; and
(b) Identified Compounds and Evaluation Compounds arising
during and out of the Screening Activities,
including, without limitation, Intellectual Property Rights
claiming Cerylid Inventions described in paragraph (a) or (b)
of this definition;
"CERYLID LIBRARY" means natural product extracts Controlled by
Cerylid during the Term;
"CERYLID PATENTS" means all patents and patent applications
claiming Cerylid Inventions;
"CHARACTERISATION" means chemical isolation and determination
of chemical structure;
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"CHARACTERISATION FEE" means the characterisation fee
specified in Item 7 of Schedule 1;
"CLAIM" means any claim, cost, damages, debt, expense,
liability, loss, suit, action, demand, cause of action or
proceeding of any kind initiated by a third party irrespective
of:
(a) how or when it arises;
(b) whether it is actual or contingent;
(c) whether or not it is in respect of legal or other
costs, damages, expenses, fees or losses;
(d) whether or not it is in respect of a breach of trust
or of a fiduciary or other duty or obligation; and
(e) whether or not it arises at law or otherwise;
"COMMENCEMENT DATE" means the date of this Agreement;
"COMPOUND SAMPLE" means a sample comprising sufficient
material to conduct reasonable follow-up biological and
chemical characterization of activity (typically [...***...]
mg) of an Identified Compound;
"CONFIDENTIAL INFORMATION" means all of the Information, other
than any part of the Information that:
(a) is or becomes generally available to the public other
than as a result of a breach by the Recipient of this
Agreement;
(b) was known to the Recipient or any of its officers,
representatives, employees or advisers (as evidenced
by written records of the Recipient made prior to the
time the Information is disclosed to the Recipient)
on a non-confidential basis before the Recipient
received the Information; or
(c) became available to the Recipient or any of its
officers, representatives, employees or advisers on a
non-confidential basis from another source not in
breach of an obligation of confidence owing by that
source to the Discloser (of which the Recipient was
aware or ought to have been aware);
"CONTROLLED" means, with respect to any material, information
or Intellectual Property Right, that the Party owns or has a
licence to such material, information or Intellectual Property
Right and has the ability to grant access, a licence or a
sublicence to such material,
***CONFIDENTIAL TREATMENT REQUESTED
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information or intellectual property right to the other Party
as provided for in this Agreement without violating an
agreement with a Third Party as of the time the Party would be
first required under this Agreement to grant the other Party
such access, licence or sublicense.
"CONTROLLER" has the meaning given to it in the Corporations
Act;
"CORPORATIONS ACT" means the Corporations ▇▇▇ ▇▇▇▇ (Cth);
"DEFAULT RATE" means the aggregate of the Interest Rate and
[...***...]% per annum;
"DEREPLICATION" means the process by which the number of
confirmed Hit Extracts from a Screen are reduced to a
sub-population thought to encapsulate all chemical species of
potential interest;
"DEREPLICATION FEE" means the dereplication fee specified in
Item 7 of Schedule 1;
"EVALUATION COMPOUND" means an Identified Compound in respect
of which Anadys has given Cerylid an Evaluation Notice;
"EVALUATION COMPOUND FEE" means the amount specified in Item 8
of Schedule 1;
"EVALUATION NOTICE" means a notice in writing which identifies
an Identified Compound in respect of which Anadys wishes to
undertake further evaluation;
"EVALUATION NOTICE DATE" means the date on which Anadys gives
Cerylid an Evaluation Notice;
"EVALUATION PERIOD" means, in respect of an Evaluation
Compound, the period specified in Item 6 of Schedule 1
commencing on the Evaluation Notice Date in respect of that
Evaluation Compound;
"EVENT OF DEFAULT" means, in relation to a Party:
(a) an Insolvency Event occurs; or
(b) a Party commits a material breach of its obligations
under this Agreement which:
(i) if capable of being remedied, is not
remedied within 30 Business Days of notice
from the other Party, specifying the breach
and requiring it to be remedied; or
(ii) is not capable of remedy;
***CONFIDENTIAL TREATMENT REQUESTED
5
"EXTRACT" means a solution or suspension of chemicals derived
from a specimen of biota or the residue from the evaporation
of solvent from such a solution or suspension;
"FIELD" means the field described in Item 4 of Schedule 1;
"FINAL REPORT" means a comprehensive research report prepared
by Cerylid setting forth the results of the Dereplication and
the Characterisation undertaken by Cerylid in accordance with
this Agreement;
"FTE" means the equivalent of 12 months' (including normal
vacation days, sick days and holidays) work of a person,
carried out by 1 or more employees or consultants of a Party,
who devotes a portion of his or her time to the Research;
"GOVERNMENTAL AGENCY" means:
(a) a government, whether foreign, federal, state,
territorial or local;
(b) a department, office or minister of a government
acting in that capacity; or
(c) a commission, delegate, instrumentality, agency,
board, or other governmental, semi-governmental,
judicial, administrative, monetary or fiscal
authority, whether statutory or not;
"HIT EXTRACT" means a Sample Extract with evidence of
biological activity in a Screen, which the Management
Committee (and ultimately Anadys, pursuant to Clause 15.2)
considers warrants progression to further evaluation;
"HPLC FRACTIONATION" means fractionation of Hit Extracts using
high pressure liquid chromatography gradients tailored to the
relevant polarity ranges in which bioactivities are localised,
yielding 40 fractions per parent extract in which active
compounds will be in Substantially Pure form;
"IDENTIFIED COMPOUND" means a compound, or group of related
compounds, that has been Characterised by Cerylid as a result
of the Screening Activities, and that, as of the Structural
Disclosure Date, is not:
(a) already licensed to or subject to an option to
licence (which Cerylid does not have the unilateral
right to terminate) by a Third Party to whom Cerylid
is contractually bound; or
(b) then under active development by Cerylid or any of
its Related Bodies Corporate;
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"INFORMATION" means the terms of this Agreement and all
information in any way relating to a Party or the business of
that Party including without limitation:
(a) marketing and technical information;
(b) customer, supplier, sales and receivables
information;
(c) the processes, mechanisms and methodologies used by
the Party in its business; and
(d) all financial information relating to that Party,
which is or has been disclosed (whether in writing, orally or
by any other means and whether directly or indirectly) to or
otherwise ascertained by the Recipient or its officers,
representatives, employees or advisers;
"INSOLVENCY EVENT" means, in relation to a Party, the
occurrence of any one or more of these events in relation to
that Party:
(a) except for the purpose of a solvent reconstruction or
amalgamation which has the prior written consent of
the other Party:
(i) process is filed in a court seeking an order
that it be wound up or that a Controller be
appointed to it or any of its assets, unless
the application is withdrawn, struck out or
dismissed within 15 Business Days of it
being filed; or
(ii) an order is made that it be wound up or that
a Controller be appointed to it or any of
its assets; or
(iii) a resolution that it be wound up is passed
by such Party;
(b) a liquidator, provisional liquidator, administrator,
Controller or any similar official is appointed to,
or takes possession or control of, all or any of its
assets or undertaking;
(c) it enters into an arrangement, compromise or
composition with any class of its creditors, or
process is filed in a court seeking approval of any
such arrangement, compromise or composition;
(d) any action is taken by a Governmental Agency with a
view to cancelling its registration or to dissolving
it, or an application is made to the Governmental
Agency that any such action be taken;
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(e) it is insolvent within the meaning of section 95A of
the Corporations Act, or it otherwise states that it
is unable to pay its debts, or it is presumed to be
insolvent under any applicable law;
(f) it stops or suspends the payment of all or a class of
its debts;
(g) it stops or suspends the conduct of all or
substantially all of its business; or
(h) anything having a substantially similar effect to any
of the events specified in the preceding paragraphs
happens to it under the law of any jurisdiction;
"INTELLECTUAL PROPERTY RIGHTS" means patents, copyright,
registered and unregistered design rights, registered and
unregistered trade marks, rights in know-how and confidential
information and all other intellectual and industrial property
rights (without limitation) and similar or analogous rights
existing under the laws of any country and all rights to apply
for or register such rights;
"INTEREST RATE" means, for any day, the rate percent per annum
that is described as the "Average Mid Rate" and appears on the
page entitled "BBSY" on the Reuters monitor system at or about
10.00 am on that day for a bank accepted ▇▇▇▇ of exchange
having a tenor of 30 days.
"INVENTIONS" means all Intellectual Property Rights created or
developed in the course of conducting the Research under this
Agreement or conceived of and reduced to practice as part of
the activities contemplated by this Agreement;
"JOINT INVENTIONS" means all Inventions created or developed
by or conceived of and reduced to practice as part of the
Screening Activities jointly by employees or contractors of
Cerylid and employees or contractors of Anadys including,
without limitation, Intellectual Property Rights claiming such
Inventions;
"JOINT PATENTS" means all patents and patent applications
claiming Joint Inventions;
"LC/MS ANALYSIS" means the technique of liquid
chromatography-mass spectroscopy;
"LICENCE" means a licence in the form of Schedule 3;
"LICENCE FEE" means the licence fee specified in Item 13 of
Schedule 1;
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"MANAGEMENT COMMITTEE" means the committee established
pursuant to clause 14.2;
"PARTY" means a party to this Agreement;
"PERMITTED PURPOSE" means testing Sample Extracts for
biological activity against one or more Targets in the Field,
conducting LC/MS Analysis and all other activities
contemplated by this Agreement or the Research Plan;
"PRIMARY ASSAY" means an in vitro or biological assay
developed for the purpose of initial testing of Sample
Extracts to identify a sub-population of Sample Extracts which
show biological activity in the assay;
"PRIORITY HIT EXTRACTS" means those Hit Extracts, following
Dereplication, identified by the Management Committee on a
sound scientific basis as warranting further analysis, and
that are successfully regenerated by Refermentation of the
Producing Organism (or if not successfully regenerated by
Refermentation, such other Hit Extract nominated by Anadys on
a sound scientific basis) provided, however, that Anadys
shall, at its reasonable discretion have the final right to
determine whether the Priority Hit Extracts are advanced in
accordance with the Research Plan;
"PRODUCING ORGANISM" means a microbial isolate, the
fermentation and extraction of which yields a Hit Extract;
"QUARTER" means a period of 3 months ending on 31 March, 30
June, 30 September and 31 December respectively;
"RECIPIENT" means a Party that has received Confidential
Information of the other Party from the other Party;
"REFERMENTATION" means the process of repeating the
fermentation of a Producing Organism to yield a larger
quantity of a Hit Extract for the purpose of Characterisation;
"RELATED BODY CORPORATE" of a body corporate means another
body corporate which is related to the first body corporate
within the meaning of Section 50 of the Corporations Act;
"RESEARCH" means the collaborative research efforts of the
Parties to be conducted pursuant to this Agreement and the
Research Plan;
"RESEARCH PLAN" means the plan attached as Schedule 2;
"SAMPLE EXTRACTS" means the number of Extracts specified in
Item 9 of Schedule 1 from the Cerylid Library, of a Standard
Volume, the composition of which is as agreed by the Parties;
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"SCREENING ACTIVITIES" means undertaking:
(a) Screens pursuant to Clause 5;
(b) Dereplication pursuant to Clause 7.1;
(c) Characterisation pursuant to Clause 7.2; and
(d) LC/MS Analysis;
"SCREENING DATA" means all data arising from the Screening
Activities;
"SCREENING EVENT" means the exposure of a Primary Assay to one
Extract on a single occasion;
"SCREENS" means the assays to be utilised for identification
of molecules by screening the Cerylid Library against Targets
in the Field, being any Primary Assay determined by Anadys and
approved by Cerylid in accordance with this Agreement and
Secondary Tests determined by Anadys for the purposes of this
Agreement;
"SECONDARY TESTS" means a combination of re-testing a Sample
Extract in the Primary Assay to confirm that the biological
activity of the Sample Extract observed on a single occasion
can be reproduced, and testing of the Sample Extract, or
additional samples derived therefrom, in any additional
biological assays which, at Anadys' reasonable discretion, are
deemed to be necessary in order to confirm biological activity
or rule out trivial or non-specific explanations for the
biological activity of the Sample Extract in the Primary
Assay;
"SECURITY INTEREST" means any mortgage, pledge, lien,
hypothecation, charge or other form of security interest or
interest in the nature of a security interest whatsoever;
"SELECTED COMPOUND" means an Evaluation Compound in respect of
which Anadys has given Cerylid a Selected Compound Notice;
"SELECTED COMPOUND NOTICE" means a notice in writing
identifying an Evaluation Compound in respect of which Anadys
wishes to obtain a Licence;
"SPE FRACTIONATION" means crude fractionation of Hit Extracts
by solid phase extraction yielding 10 fractions from each
parent extract to localise bioactivities to specific polarity
ranges;
10
"STANDARD VOLUME" means, in respect of a Sample Extract, a
dried amount of that Extract which was derived from at least
20 microlitres of initial extract;
"STRUCTURAL DISCLOSURE DATE" means, with respect to any
"Identified Compound", the date on which Cerylid provides to
Anadys the results of Characterisation of such Identified
Compound, including without limitation, structures of such
Identified Compound.
"SUBSTANTIALLY PURE" means consisting of approximately
[...***...]% or more of a single substance;
"TARGET" means targets which are selected by Anadys in
relation to which it proposes to conduct the Screens;
"TERM" means the period of 24 months (which may be extended if
an Uncontrollable Event (as defined below) occurs or upon
mutual agreement by the Parties) commencing on the
Commencement Date;
"THIRD PARTY" means any person or entity other than the
Parties or their respective Affiliates;
"UNCONTROLLABLE EVENT" means an event or cause beyond the
reasonable control of a Party including, without limitation:
(a) act of God, lightning, storm, flood, fire, earthquake
or explosion, cyclone, tidal wave, landslide, adverse
weather conditions;
(b) strike, lockout or other labour difficulty;
(c) act of public enemy, war (declared or undeclared),
sabotage, blockade, revolution, riot, insurrection,
civil commotion, epidemic;
(d) the effect of any applicable laws, orders, rules or
regulations or any government or other competent
authority;
(e) embargo, inability to obtain any necessary materials,
equipment, facilities or qualified employees, power
or water shortage, lack of transportation; and
(f) breakage or accident or other damage to machinery or
equipment; and
"WELL" means a well from any of the:
(a) Sample Extracts;
***CONFIDENTIAL TREATMENT REQUESTED
11
(b) fractions arising from the SPE Fractionation;
(c) fractions arising from the HPLC Fractionation; or
(d) Assay plates from a Screen.
1.2 INTERPRETATION
In this Agreement, unless the context requires otherwise:
1.2.1 reference to any legislation or to any provision of
any legislation includes any modification or
re-enactment of, or any legislative provision
substituted for, and all legislation and statutory
instruments issued under, such legislation or such
provision and includes the corresponding legislation
in such other State or Territory of the Commonwealth
of Australia as may be relevant from time to time;
1.2.2 words (including words defined in this Agreement)
denoting the singular number include the plural and
vice versa;
1.2.3 words denoting individuals include corporations and
vice versa;
1.2.4 words denoting gender include all genders;
1.2.5 "written" and "in writing" include any means of
visible reproduction of words in a tangible and
permanently visible form;
1.2.6 reference to Clauses and Schedules are references to
clauses and schedules of this Agreement;
1.2.7 reference to any document or agreement includes
references to such document or agreement as novated,
supplemented, varied or replaced from time to time;
1.2.8 references to any party to this Agreement or any
other document or agreement includes its successors
or permitted assigns;
1.2.9 where the due date for payment of any moneys is not a
Business Day such moneys shall be due for payment on
the immediately preceding Business Day;
1.2.10 references to "$" or "dollars" are references to
currency of the United States of America;
1.2.11 references to time are references to Australian
Eastern Standard Time;
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1.2.12 a reference to something being done by a given date
or within a certain time frame includes that thing
being done by any other date or within any other time
frame agreed by the parties;
1.2.13 the meaning of general words is not limited by
specific examples introduced by including for example
or other expressions.
1.3 HEADINGS
The headings in this Agreement are the purpose of more
convenient reference only and shall not form part of this
Agreement or effect its construction or interpretation.
2 FEES
2.1 ACCESS FEE
Anadys will pay the Access Fee to Cerylid, within 10 Business
Days of receipt by Anadys of the Sample Extracts, but no later
than 20 July 2002, in consideration of access to:
2.1.1 Cerylid's library of Extracts; and
2.1.2 Cerylid's expertise and assistance in selecting
Extracts for use in the Research..
Anadys must immediately notify Cerylid of its receipt of the
Sample Extracts.
2.2 PROJECT-RELATED FEES
Anadys will pay to Cerylid:
2.2.1 the Dereplication Fee in respect of each Screen from
which Hit Extracts progress to Dereplication, within
10 Business Days of commencement of Dereplication in
respect of those Hit Extracts; and
2.2.2 the Characterisation Fee in respect of each Screen
from which Priority Hit Extracts progress to
Characterisation, within the first to occur of the
expiration of 20 Business Days after completion of
the Characterisation process in respect of those
Priority Hit Extracts and the expiration of 6 months
after completion of Characterisation of the first
Priority Hit Extract.
2.3 INTEREST
Anadys must pay interest to Cerylid on all overdue amounts
under this Agreement:
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2.3.1 on a daily basis from the date that amount fell due
until the date of payment (inclusive); and
2.3.2 at the Default Rate.
3 SUPPLY OF SAMPLE EXTRACTS
3.1 SUPPLY
Cerylid will, within 20 Business Days of the Parties agreeing
on the composition of the Sample Extracts, dispatch the Sample
Extracts to Anadys.
3.2 FREIGHT AND INSURANCE
Anadys will be responsible for the cost of freight and
insurance of the Sample Extracts.
4 USE OF SAMPLE EXTRACTS
4.1 Anadys may only use the Sample Extracts for the Permitted
Purpose.
4.2 Anadys may not:
4.2.1 sell or assign the Sample Extracts to any other
person other than an Affiliate of Anadys;
4.2.2 use the Sample Extracts other than for the Permitted
Purpose; or
4.2.3 deal with the Sample Extracts in a manner
inconsistent with the Permitted Purpose.
5 SCREENS / TARGETS
5.1 NOTIFICATION OF SCREENS / TARGETS
Anadys will notify Cerylid of each Screen it proposes to
conduct and the Targets against which it intends to conduct
that Screen before conducting that Screen.
5.2 CERYLID APPROVAL
Subject to Clause 5.3, Cerylid may, within 10 Business Days of
receiving a notification from Anadys under Clause 5.2, approve
or reject that Screen and the Targets.
5.3 CIRCUMSTANCES OF REJECTION
Cerylid may only reject a Screen and Targets pursuant to
Clause 5.2 if at the time Cerylid receives notification from
Anadys pursuant to Clause 5.1:
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5.3.1 a Third Party with whom Cerylid has an existing
contractual arrangement, has delivered to Cerylid
written notice nominating that Target as a target
against which it wishes to conduct screens using
Extracts from the Cerylid Library;
5.3.2 any of those Targets were the subject of an active
screening or drug development program by Cerylid or
any of its Related Bodies Corporate.
5.4 EXCLUSIVITY
Cerylid will not conduct or authorise an Affiliate or Third
Party to conduct a screen using any of the Extracts from
Cerylid's library against:
5.4.1 any Target approved by Cerylid pursuant to Clause 5.2
during the Term;
5.4.2 any Target from which an Identified Compound or
Evaluation Compound has been derived, for the period
of the Assessment Period and Evaluation Period
respectively in relation to that compound; and
5.4.3 any Target from which a Selected Compound has been
derived:
5.4.3.1 for the period of [...***...] months; or
5.4.3.2 upon additional payment of $[...***...] by
Anadys to Cerylid, [...***...] months,
from the commencement of the Licence in respect of
that Selected Compound.
6 SCREENING
Anadys will:
6.1 conduct each Screen accepted pursuant to Clause 5.2, (in
accordance with the Research Plan) within [...***...] days of
acceptance of that Screen by Cerylid ; and
6.2 following completion of each Screen, provide Cerylid with the
Anadys Screening Data for such Screen and a list of all
Extracts in which bioactivity has been confirmed by retest.
***CONFIDENTIAL TREATMENT REQUESTED
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7 DEREPLICATION AND CHARACTERISATION
7.1 DEREPLICATION
7.1.1 Within 90 days following receipt of all of the Anadys
Screening Data as to each Screen, the Management
Committee will agree upon a list of Hit Extracts, and
Cerylid will commence Dereplication (in accordance
with the Research Plan) on up to, the number of Hit
Extracts for each Screen conducted by Anadys
specified in Item 10 of Schedule 1 and complete that
Dereplication as soon as reasonably practicable.
7.1.2 Dereplication will occur in a 2 stage process
involving:
7.1.2.1 SPE Fractionation; and
7.1.2.2 HPLC Fractionation.
7.1.3 Notwithstanding Clause 7.1.1, if after providing
Anadys Screening Data to Cerylid and discussing such
data with Cerylid representatives, Anadys determines,
in its sole discretion, that it does not desire for
Cerylid to initiate Dereplication with respect to the
Hit Extracts resulting from a particular Screen,
Anadys may at the time it provides the Anadys
Screening Data to Cerylid in accordance with Clause
5.2 above, inform Cerylid of its desire to initiate a
replacement Screen, in which case it shall select
another target and initiate the procedures set forth
in Clause 5 and complete them within a further 90
days, with no additional payment owed to Cerylid. At
its discretion, Anadys may conduct any number of
replacement Screens, provided that it provides
Cerylid with the final set of screening data within
180 days from the receipt of Sample Extracts, and
that all Hit Extracts specified are derived from
screening of the same target.
7.2 CHARACTERISATION
The Parties will work together to conduct Characterisation in
accordance with the Research Plan of up to the number of
Priority Hit Extracts specified in Item 11 of Schedule 1 for
each Screen conducted by Anadys and complete that
Characterisation as soon as practicable following
Dereplication pursuant to Clause 7.1. The Parties acknowledge
that, for the purpose of determining the number of Priority
Hit Extracts in respect of which Characterisation has been
conducted, compounds or groups of related compounds that are
Characterised by Cerylid but which are determined following
Characterisation to come within paragraph (a) or (b) of the
definition of "Identified Compound" are excluded.
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8 TERM
This Agreement will commence on the Commencement Date and, unless
terminated earlier in accordance with its terms, will expire upon the
expiry of the Term. The Parties may from time to time agree to extend
this Agreement to allow sufficient time to conduct additional Screens.
9 REPORTING
Cerylid:
9.1 and Anadys will have regular teleconferences at
intervals and with timing to be agreed upon by the
parties with mutually approved minutes for the
purpose of discussing the progress of Cerylid's
Dereplication and Characterisation activities;
9.2 will provide to Anadys a Final Report at the
conclusion of its Dereplication and Characterisation
activities for each Screen (and in any event within
20 Business Days of completion of Characterisation);
9.3 will provide to Anadys prompt written notification of
any change in Cerylid's contractual arrangement with
any Third Party which has the effect of eliminating
or modifying the restriction on antibacterial targets
as contemplated by the initial definition of the
Field; and
9.4 will, upon shipping the Extracts and at each time
Cerylid ships fractions to Anadys, inform Anadys, in
writing, whether any of the ▇▇▇▇▇, or any of the
compounds derived from any of the ▇▇▇▇▇, are subject
to any exclusive option or license with any Third
Party.
10 IDENTIFIED COMPOUNDS
10.1 NOTIFICATION BY CERYLID
Cerylid will, as soon as reasonably practicable after
identifying an Identified Compound:
10.1.1 notify Anadys in writing of the identity of that
Identified Compound;
10.1.2 unless it has already done so, provide to Anadys, all
information and data generated by Cerylid in respect
of that Identified Compound; and
10.1.3 at the request of Anadys, use commercially reasonable
efforts to provide to Anadys a Compound Sample of
that Identified Compound.
17
10.2 ASSESSMENT PERIOD
Anadys may during the Assessment Period:
10.2.1 conduct further assessment and analysis of an
Identified Compound; and
10.2.2 nominate an Identified Compound as an Evaluation
Compound by giving an Evaluation Notice to Cerylid
and paying to Cerylid the Evaluation Compound Fee (if
an Evaluation Compound Fee is required in respect of
that Identified Compound nominated as an Evaluation
Compound in accordance with Item 8 of Schedule 1).
11 EVALUATION COMPOUNDS
11.1 RIGHTS OF CUSTOMER
Anadys may, during the Evaluation Period for any Evaluation
Compound:
11.1.1 conduct further medicinal or combinatorial chemistry
and biological and pharmacological analysis of
Evaluation Compounds; and
11.1.2 subject to Clause 12, obtain a Licence of an
Evaluation Compound, by giving to Cerylid a Selected
Compound Notice and paying the Licence Fee to
Cerylid.
11.2 SUPPLY OF EVALUATION COMPOUNDS
Anadys may, during the Evaluation Period for any Evaluation
Compound, request Cerylid to provide to Anadys additional
amounts of such Evaluation Compound. Cerylid will, if it has
not already provided a Compound Sample in respect of such
Evaluation Compound to Anadys pursuant to Clause 10.1.3, use
commercially reasonable efforts to supply to Anadys the
amounts of the Evaluation Compound requested by Anadys, and,
in any event, at least [...***...] of such Evaluation
Compound, at no charge to Anadys. If Cerylid is unable to
obtain amounts requested in excess of [...***...] of the
Evaluation Compound without incurring additional expense or
without being required to undertake additional activities,
Cerylid will notify Anadys in writing of the costs of
supplying such amount before supplying that amount to Anadys.
The costs of supplying such amount will be calculated on the
basis that Cerylid will charge Anadys for the preparation and
provision of additional amounts of an Evaluation Compound that
exceed [...***...] at the FTE rate of $[...***...] per annum,
plus any out of pocket costs incurred by Cerylid that are
approved in advance by Anadys in writing. Anadys must pay
these amounts to Cerylid within 30 days of receipt of an
invoice from Cerylid.
***CONFIDENTIAL TREATMENT REQUESTED
18
12 LICENCE OF SELECTED COMPOUNDS
With respect to any Evaluation Compound, upon Anadys:
12.1 giving Cerylid a Selected Compound Notice; and
12.2 paying Cerylid the Licence Fee,
Cerylid shall automatically grant Anadys the Licence in respect of such
Selected Compounds.
13 INVENTIONS
13.1 OWNERSHIP OF INVENTIONS
13.1.1 Except as expressly set forth in this Clause 13.1,
ownership of Inventions will be determined in
accordance with the rules of inventorship under
United States patent laws.
13.1.2 Cerylid will own all Cerylid Inventions.
13.1.3 Anadys will own all Anadys Inventions.
13.1.4 Except as set forth above, Cerylid and Anadys will
jointly own all Joint Inventions.
13.2 PATENT PROSECUTION AND MAINTENANCE
13.2.1 Cerylid will be responsible for the preparation,
filing, prosecution and maintenance of all Cerylid
Patents at Cerylid's sole expense.
13.2.2 Anadys will be responsible for the preparation,
filing, prosecution and maintenance of all Anadys
Patents at Anadys' sole expense.
13.2.3 Cerylid will consider in good faith the requests and
suggestions of Anadys with respect to strategies for
filing and prosecuting Cerylid Patents claiming
Identified Compounds and Evaluation Compounds and
will keep Anadys informed of progress with regard to
such filing, prosecution, maintenance, enforcement
and defence of such Cerylid Patents. If Cerylid
desires to abandon any Cerylid Patent claiming any
Identified Compound or Evaluation Compound (except to
the extent the Evaluation Period for such Evaluation
Compound has expired unexercised), Cerylid will
provide reasonable prior written notice to Anadys of
such intention to abandon (which notice will, in any
event, be given no later than 30 days prior to the
next deadline for any action that may be taken with
respect to such Cerylid
19
Patent with the relevant patent office) and provide
Anadys an opportunity to discuss with Cerylid the
possibility of assuming responsibility for such
Cerylid Patent, provided that any such assumption of
responsibility by Anadys will be subject to the prior
written consent of Cerylid, which must not be
unreasonably withheld or delayed.
13.2.4 The Parties will agree, on a case-by-case basis,
which Party will be primarily responsible for the
preparation, filing, prosecution and maintenance of
any Joint Patents, and the parties will share the
reasonable expenses of such Joint Patents equally.
The responsible Party will consult with the other
Party as to the preparation, filing, prosecution and
maintenance of such Joint Patents reasonably prior to
any deadline or action with the relevant patent
office, and will furnish to the other Party copies of
all relevant documents reasonably in advance of such
consultation.
13.3 COOPERATION OF THE PARTIES
Each Party agrees to cooperate fully in the preparation,
filing, prosecution and maintenance of any patent rights under
this Agreement. Such cooperation includes, but is not limited
to:
13.3.1 executing all papers and instruments, or requiring
its employees or contractors, to execute such papers
and instruments, so as to effectuate the ownership of
Inventions specified in Clause 13.1, and patents
claiming or disclosing such Inventions, and to enable
the other Party to apply for and to prosecute patent
applications in any country; and
13.3.2 promptly informing the other Party of any matters
coming to such Party's attention that may affect the
preparation, filing, prosecution or maintenance of
any such patent applications.
13.4 INFRINGEMENT BY THIRD PARTIES
13.4.1 Anadys and Cerylid must promptly notify the other in
writing of any alleged or threatened infringement of
any Anadys Patent, Cerylid Patent or Joint Patent of
which they become aware. Both parties shall use their
commercially reasonable efforts in cooperating with
each other to terminate such infringement without
litigation.
13.4.2 Anadys will have the sole right to bring and control
any action or proceeding with respect to infringement
of any
20
Anadys Patent at its own expense and by counsel of
its own choice.
13.4.3 Subject to Clause 13.4.4, Cerylid will have the sole
right to bring and control any action or proceeding
with respect to infringement of any Cerylid Patent at
its own expense and by counsel of its own choice.
13.4.4 With respect to infringement of any Cerylid Patent
claiming any Identified Compound or Evaluation
Compound (except to the extent the Evaluation Period
for such Evaluation Compound has expired
unexercised), Anadys will have the right, at its own
expense, to be represented in any such action by
counsel of its own choice, and if Cerylid fails to
bring an action or proceeding within:
13.4.4.1 60 days following the notice of alleged
infringement; or
13.4.4.2 10 days before the time limit, if any, set
forth in the appropriate laws and
regulations for the filing of such actions,
whichever comes first, Anadys will have the right to
bring and control any such action at its own expense
and by counsel of its own choice, and Cerylid will
have the right, at its own expense, to be represented
in any such action by counsel of its own choice.
13.4.5 With respect to infringement of any Joint Patent, the
Parties will agree, on a case-by-case basis, which
party will be responsible for bringing and
controlling any infringement action.
13.4.6 If a Party brings an infringement action in
accordance with this Clause 13.4, the other Party
will shall cooperate fully, including, if required to
bring such action, the furnishing of a power of
attorney or being named as a Party.
13.4.7 Neither Party will shall have the right to settle any
patent infringement litigation under this Clause 13.4
in a manner that diminishes the rights or interests
of the other Party without the prior written consent
of that other Party (which must not be unreasonably
withheld).
13.4.8 Except as otherwise agreed to by the Parties as part
of a cost-sharing arrangement, any recovery realized
as a result of any litigation under this Clause 13.4,
after reimbursement of any litigation expenses of
Anadys and
21
Cerylid, will be retained by the Party that brought
and controlled such litigation for purposes of this
Agreement.
13.5 INFRINGEMENT OF THIRD PARTY RIGHTS
13.5.1 Each Party must promptly notify the other in writing
of any allegation by a Third Party that the activity
of either of the Parties pursuant to this Agreement
infringes or may infringe the Intellectual Property
Rights of that Third Party.
13.5.2 Anadys will have the sole right to control any
defence of any such claim involving alleged
infringement of Third Party rights by Anadys'
activities at its own expense and by counsel of its
own choice, and Cerylid will have the right, at its
own expense, to be represented in any such action by
counsel of its own choice.
13.5.3 Cerylid will have the sole right to control any
defence of any such claim involving alleged
infringement of Third Party rights by Cerylid's
activities at its own expense and by counsel of its
own choice, and Anadys will have the right, at its
own expense, to be represented in any such action by
counsel of its own choice.
13.5.4 Neither Party shall have the right to settle any
patent infringement litigation under this Clause 13.5
in a manner that diminishes the rights or interests
of the other Party without the written consent of
such other Party (which must not be unreasonably
withheld).
14 PRIOR RIGHTS
14.1 PRIOR THIRD PARTY RIGHTS
Anadys acknowledges and agrees that:
14.1.1 Cerylid has various screening agreements and
collaboration agreements with other parties;
14.1.2 other parties may obtain exclusive rights to a
compound pursuant to other screening agreements or
collaboration agreements that Cerylid has entered;
and
14.1.3 Anadys will have no right to obtain a Licence or any
other right in relation to a compound if:
14.1.3.1 any other party has acquired prior rights or
an option in relation to that same compound
or family of compounds; or
22
14.1.3.2 that compound is then under active
development by Cerylid or any of its Related
Bodies Corporate.
14.2 CERYLID NOT TO GRANT OTHER RIGHTS
Notwithstanding Clause 14.1, except to the extent that Cerylid
is required to do so pursuant to an agreement with a Third
Party that was in existence as at the date of this Agreement:
14.2.1 commencing on the Structural Disclosure Date with
respect to any Identified Compound and continuing for
the duration of the Assessment Period with respect to
such Identified Compound, Cerylid will not grant to
any Third Party any license or other rights in such
Identified Compound, or take any other action that
would prohibit or restrict Cerylid from granting a
Licence to Anadys with respect to such Identified
Compound in accordance with this Agreement; and
14.2.2 during the Evaluation Period with respect to any
Evaluation Compound, Cerylid will not grant to any
Third Party any license or other rights in such
Evaluation Compound, or take any other action that
would prohibit or restrict Cerylid from granting a
Licence to Anadys with respect to such Evaluation
Compound in accordance with this Agreement.
15 MANAGEMENT COMMITTEE AND REPORTING
15.1 ESTABLISHMENT OF MANAGEMENT COMMITTEE
Cerylid and Anadys will establish a joint committee consisting
of the number of representatives specified in Item 12 of
Schedule 1, with each of Cerylid and Anadys appointing half of
that number of representatives or such other agreed equal
number of representatives from Cerylid and Anadys. One member
appointed by each party will be a business person.
15.2 PURPOSE OF THE MANAGEMENT COMMITTEE
The Management Committee will meet by teleconference at
intervals to be agreed by the Parties and at such other times
and in such other manner as may be determined by the
Management Committee for the purpose of:
(a) co-ordinating the activities to be undertaken
pursuant to this Agreement;
(b) considering the composition of the Sample Extracts
which should be accessed for the Screens;
23
(c) assessing and determining Hit Extracts and Priority
Hit Extracts; and
(d) reviewing the progress and the results of the
Screening Activities and discussing the progression
of Hit Extracts, Priority Hit Extracts and Identified
Compounds emanating from the Screens,
(e) The business person member of the management
committee will be responsible for ensuring that any
contractual modifications and/or amendments,
necessary and mutually agreed upon, are implemented
in a timely manner
Notwithstanding the foregoing, Anadys shall have the ultimate
authority to determine, based upon sound scientific, financial
or commercial bases, in its sole discretion, the outcome with
respect to all decisions falling within subsection 15.2 above.
In making any such determination Anadys must act reasonably
and may not require Cerylid to undertake Dereplication on any
Hit Extracts that are obviously spurious or of no interest.
15.3 ANADYS' AUTHORITY
The Parties acknowledge and agree that Anadys, as the paying
Party under this Agreement, shall, within the terms of this
Agreement, have the ultimate authority (which authority shall
override any determination or recommendation of the Management
Committee or Cerylid) to direct and control the Research,
including, without limitation, having the ultimate
determination of the identity and number of Hit Extracts and
Priority Hit Extracts, and the ability to determine whether
the Research Plan is progressed with respect to any given
Target or Extract.
16 TERMINATION
16.1 TERMINATION BY NOTICE
A Party may immediately terminate this Agreement by notice in
writing to the other Party, if an Event of Default occurs in
relation to that other Party.
16.2 CONSEQUENCES OF TERMINATION
Termination of this Agreement will not affect any rights or
liabilities that the Parties accrued prior to termination.
24
16.3 SURVIVAL
The rights of the Parties under Clauses 4, 1.1, 11, 1, 13, 17,
18, 21, 22, 24, 25.1, 25.2, 25.3 and 26 shall survive
termination or expiration of this Agreement, except that
Clauses 1.1, 11 and 1 will not survive a termination of this
Agreement pursuant to Clause 16.1.
17 DISPUTE RESOLUTION
17.1 COMPULSORY ALTERNATIVE DISPUTE RESOLUTION
The Parties must comply with the dispute resolution procedure
described in clause 17.2. Subject to clause 17.5 neither Party
will be entitled to commence any litigation or arbitration in
relation to any matter arising directly or indirectly out of
this Agreement until they have complied with clause 17.2.
17.2 PRIMARY DISPUTE RESOLUTION PROCEDURE
The Parties recognize that disputes as to certain matters may
from time to time arise which relate to either Party's rights
and/or obligations hereunder. It is the objective of the
Parties to establish procedures to facilitate the resolution
of such disputes in an expedient manner by mutual cooperation.
To accomplish this objective, the parties agree to follow the
primary dispute resolution procedures set forth in this Clause
17 if and when such a dispute arises between the Parties. If
any claim, dispute, or controversy of whatever nature arising
out of or relating to this Agreement, including, without
limitation, any action or claim based on tort, contract, or
statute, or concerning the interpretation, effect,
termination, validity, performance and/or breach of this
Agreement ("DISPUTE"), arises between the Parties and the
Parties, through the Management Committee, cannot resolve the
dispute within 30 days of a written request by either Party to
the other Party, the Parties agree to refer the Dispute to the
Chief Executive Officer of each Party for resolution. If,
after 45 days, the respective Chief Executive Officers have
not succeeded in negotiating a resolution of the dispute, then
the Parties may proceed to the secondary dispute resolution
procedures set forth in Clause 17.3.
17.3 SECONDARY DISPUTE RESOLUTION PROCEDURE
If the Parties are not successful in resolving a Dispute
pursuant to the Primary Dispute Resolution Procedures set
forth in Clause 17.2, then the secondary dispute resolution
procedure required to be complied with prior to the
commencement of litigation or arbitration is as follows:
25
17.3.1 where a dispute arises between the Parties, a Party
may serve a written notice (the "Dispute Notice") on
the other Party detailing the nature of the dispute;
17.3.2 the Parties must make reasonable efforts to resolve
the dispute by negotiation;
17.3.3 if the Parties are unable to resolve the dispute
within 28 days of the receipt of the Dispute Notice,
either Party may by notice in writing to the other
Party (the "Mediation Notice") require that the
dispute be referred to mediation;
17.3.4 within 28 days of receipt of the Mediation Notice the
dispute will be referred to a mediator as agreed
between the Parties, and failing agreement, to a
mediator appointed by the President of the Law
Institute of Victoria on the application of either
Party;
17.3.5 the costs of the mediator will be paid equally by the
Parties but otherwise the Parties must pay their own
costs of the mediation;
17.3.6 the Parties must approach the mediation in good faith
and make a reasonable attempt to settle the dispute
by mediation and within the framework determined by
the mediation.
17.4 RIGHT TO LITIGATE
If the mediation fails to settle the dispute, the Parties may
institute litigation or arbitration.
17.5 URGENT RELIEF
Nothing in this clause will prevent either Party from seeking
urgent interlocutory relief where failure to obtain such
relief would cause irreparable damage to that Party.
18 CONFIDENTIAL INFORMATION
18.1 OBLIGATION TO MAINTAIN CONFIDENTIALITY
Each Party must keep all Confidential Information of the other
Party strictly confidential and must not, and must ensure that
its respective officers, employees, agents and auditors do
not, without the prior written consent of the other Party,
disclose any of such Confidential Information to any third
party except for a permitted disclosure pursuant to clause
18.2.
18.2 PERMITTED DISCLOSURE
26
A Party may disclose Confidential Information of the other
Party:
18.2.1 if required to make such disclosure by any court of
competent jurisdiction or in order to enforce any
rights under this instrument in any proceedings;
18.2.2 pursuant to any court order;
18.2.3 pursuant to any law or regulation having the force of
law;
18.2.4 pursuant to any requirements of any stock exchange on
which securities in a Party are listed;
18.2.5 on a confidential basis, to a professional adviser
(acting in that capacity) if the adviser has agreed
in writing to observe the requirements of clause
18.1; and
18.2.6 to another Party.
18.2.7 in the case of Cerylid, to the extent reasonably
necessary to register any Intellectual Property
Rights in relation to any of the Confidential
Information; and
18.2.8 to a potential financier, investor or purchaser of a
Party, if that financier, investor or purchaser has
first agreed in writing to observe the requirements
of clause 18.1.
18.3 NOTICE; PROTECTIVE ORDER
Notwithstanding the foregoing, in the event a Party is
required to make a disclosure of the other Party's
Confidential Information pursuant to Clause 18.2.1, 18.2.2,
18.2.3 or 18.2.4, it will give reasonable advance notice to
the other Party of such disclosure and endeavour in good faith
to secure confidential treatment of such information or a
protective order related to such information requiring that
the information so disclosed be used only for the purpose for
which disclosure was required. In any event, the Parties agree
to take all reasonable action to avoid disclosure of
Confidential Information hereunder.
18.4 INJUNCTIVE RELIEF
Each Party acknowledges that monetary damages alone would not
be adequate compensation to any other Party for a breach of
clause 18.1 and that any other Party is entitled obtain an to
seek an injunction from a court of competent jurisdiction (in
addition to other relief that may be available) if a Party
fails to comply or threatens to fail to comply with clause
18.1.
27
19 PUBLICITY
19.1 ANNOUNCEMENTS
No public announcement of this Agreement may be made by either
Party otherwise than in a form approved by both Parties.
19.2 ANNOUNCEMENTS TO STOCK EXCHANGE
If, despite the provisions of Clause 18.3, the Parties are
unable to agree a joint announcement in a form reasonably
acceptable to each Party on or before the day on which a Party
is required to make disclosure to any stock exchange (a
"Listed Party"), the Listed Party may make an announcement to
the stock exchange containing the minimum amount of
information necessary to comply with its disclosure
requirements. The Listed Party must, unless otherwise required
by any listing rules or law applicable to that Party or it is
not reasonably practicable, provide the other Party with a
copy of the announcement at least 48 hours prior to the
announcement.
20 REPRESENTATIONS AND WARRANTIES
20.1 REPRESENTATIONS OF BOTH PARTIES
Each Party represents and warrants to the other Party as at
the Commencement Date that:
20.1.1 it is duly incorporated and the execution, delivery
and performance of this Agreement does not violate
its constitution or charter documents, as applicable;
20.1.2 it has the power and has taken all corporate and
other action required to enter into this Agreement
and to authorise the execution and delivery of this
Agreement and the performance of its obligations
under this Agreement;
20.1.3 this Agreement constitutes a valid and legally
binding obligation of it in accordance with its
terms; and
20.1.4 to its knowledge, the execution, delivery and
performance of this Agreement does not violate any
existing law or any document or agreement to which it
is a party or which is binding on it or any of its
assets.
20.2 STATUS OF REPRESENTATIONS
All representations and warranties in this Agreement:
20.2.1 survive the execution and delivery of this Agreement;
28
20.2.2 remain in full force and effect for the term of this
Agreement; and
20.2.3 are given with the intent that liability under those
representations and warranties will not be confined
to breaches discovered prior to the date of this
Agreement.
21 LIMITATION OF LIABILITY
21.1 EXCLUSION OF TERMS AND WARRANTIES
To the maximum extent permitted by law all terms and
warranties expressed or implied by any legislation, the common
law, equity, trade, custom or usage or otherwise in connection
with this Agreement are expressly excluded.
21.2 REQUIRED STATUTORY WARRANTIES
If any legislation implies in this Agreement any term or
warranty and also prohibits provisions in a contract excluding
or modifying the application of or liability under that term
or warranty, that term or warranty is deemed to be included in
this Agreement.
21.3 LIMITATION OF LIABILITY
If any legislation implies in this Agreement any term or
warranty and also prohibits provisions in a contract excluding
the application of that term or warranty then, to the maximum
extent permitted by law, the liability of each Party for a
breach of such a term or warranty will be limited, at the
option of such Party, to any one or more of the following:
21.3.1 if the breach relates to goods:
21.3.1.1 the replacement of the goods or the supply
of equivalent goods;
21.3.1.2 the repair of such goods;
21.3.1.3 the payment of the cost of replacing the
goods or of acquiring equivalent goods; or
21.3.1.4 the payment of the cost of having the goods
repaired; and
21.3.2 if the breach relates to services:
21.3.2.1 the supplying of the services again; or
21.3.2.2 the payment of the cost of having the
services supplied again.
29
In addition, subject to the Parties' obligations under clause
22 and except for liability for breach of clause 18, neither
Party shall be entitled to recover from the other Party any
special, incidental, consequential or punitive damages in
connection with this Agreement.
22 INDEMNITY
22.1 CERYLID'S INDEMNITY
Anadys indemnifies Cerylid, its servants and agents against
all Claims (including the cost of defending or settling any
Claim) which may be instituted against or incurred by Cerylid
arising out of:
22.1.1 a breach of this Agreement by Anadys; or
22.1.2 the gross negligence or wilful misconduct of Anadys,
its agents, employees or sub-contractors.
22.2 ANADYS' INDEMNITY
Cerylid indemnifies Anadys, its servants and agents against
all Claims (including the cost of defending or settling any
Claim) which may be instituted against or incurred by Anadys
arising out of:
22.2.1 a breach of this Agreement by Cerylid; or
22.2.2 the gross negligence or wilful misconduct of Cerylid,
its agents, employees or sub-contractors.
22.3 STATUS OF INDEMNITY
Each indemnity in this Agreement:
22.3.1 is a continuing obligation;
22.3.2 constitutes a separate and independent obligation of
the Party giving the indemnity from its other
obligations under this Agreement; and
22.3.3 survives termination of this Agreement.
23 UNCONTROLLABLE EVENTS
23.1 UNCONTROLLABLE EVENT
If a Party is prevented in whole or in part from carrying out
its obligations under this Agreement as a result of an
Uncontrollable Event, it must promptly notify the other Party
accordingly. The notice must:
23.1.1 specify the obligations it cannot perform;
30
23.1.2 reasonably describe the Uncontrollable Event;
23.1.3 estimate the time during which the Uncontrollable
Event will continue; and
23.1.4 specify the measures proposed to be adopted to remedy
or ▇▇▇▇▇ the Uncontrollable Event.
23.2 SUSPENSION OF OBLIGATIONS
Following the notice under clause 23.1, and while the
Uncontrollable Event continues, the obligations of a Party
which cannot be performed because of the Uncontrollable Event
will be suspended.
23.3 OBLIGATIONS OF PARTIES
Each Party must:
23.3.1 use its reasonable endeavours to remedy the
Uncontrollable Event to the extent reasonably
practicable and resume performance of its obligations
as soon as reasonably possible; and
23.3.2 take all action reasonably practicable to mitigate
any loss suffered by the other Party as a result of
its failure to carry out its obligations under this
Agreement.
23.4 LIMIT OF OBLIGATIONS
A Party is not required, under clause 23.3, to settle any
labour dispute against its will or to test the validity or
refrain from testing the validity of federal, state or local
law, order, rule or regulation.
23.5 EXTENDED EXISTENCE OF UNCONTROLLABLE EVENT
If a Party is prevented from carrying out its obligations
under this Agreement as a result of an Uncontrollable Event
for a period of 3 months:
23.5.1 the Parties must consult with each other in good
faith with a view to assessing the likelihood of the
Uncontrollable Event continuing; and
23.5.2 if in the reasonable opinion of a Party substantial
performance of the other Party's obligations under
this Agreement (having regard to the remaining term
of the Agreement) is unlikely because of the
Uncontrollable Event that Party may terminate this
Agreement by 30 days written notice to the other
Party without prejudice to the rights of either Party
accrued prior to the date of termination.
31
23.6 EXTENSION
Subject to Clause 23.5, the term of this Agreement will be
extended by the period of the Uncontrollable Event.
23.7 PAYMENT OF MONEY
This Clause 23 does not affect a Party's obligation to make a
payment to the other Party.
24 NOTICES
Any notice required to be given under this Agreement by any party to
another shall be:
24.1 in writing addressed to the address of the intended recipient
shown in this Agreement below or to such other address as has
been most recently notified by the intended recipient to the
Party giving the notice:
in the case of Cerylid:
Address: ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇
Fax: [...***...]
E-mail ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇.▇▇▇.▇▇
Attention: Vice President, Business Development
in the case of Anadys:
in accordance with Item 14 of Schedule 1.
24.2 signed by a person duly authorised by the sender; and
24.3 deemed to have been given and served:
24.3.1 where delivered by hand, at the time delivery;
24.3.2 where sent by facsimile transmission, 24 hours after
the time recorded on the transmission report unless:
24.3.2.1 within those 24 hours the intended recipient
has informed the sender that the
transmission was received in an incomplete
or garbled form; or
***CONFIDENTIAL TREATMENT REQUESTED
32
24.3.2.2 the transmission result report of the sender
indicates a faulty or incomplete
transmission;
24.3.3 where sent by e-mail, 24 hours after the time the
e-mail was sent; and
24.3.4 where sent by registered mail, on acknowledgment of
receipt by or on behalf of the recipient,
but if such delivery or receipt is on a day on which
commercial premises are not generally open for business in the
place of receipt or is later than 4.00 p.m. (local time) on
any day, the notice shall be deemed to have been given and
served on the next day on which commercial premises are
generally open for business in the place of receipt.
25 GENERAL PROVISIONS
25.1 INVALID OR UNENFORCEABLE PROVISIONS
If a provision of this Agreement is invalid or unenforceable
in a jurisdiction:
25.1.1 it is read down or severed in that jurisdiction to
the extent of the invalidity or unenforceability; and
25.1.2 it does not affect the validity or enforceability of:
25.1.2.1 that provision in another jurisdiction; or
25.1.2.2 the remaining provisions;
25.2 REPLACEMENT OF INVALID PROVISION
The Parties will seek to replace any invalid provision with a
provision which is valid, legal and enforceable having the
same effect as the provision which is severed pursuant to
clause 25.1 of this Agreement. If the Parties cannot agree on
such a provision, clause 16.3 will apply.
25.3 WAIVER
25.3.1 No right or obligation under this Agreement will be
waived except by notice in writing signed by each
Party.
25.3.2 A waiver by a Party pursuant to Clause 25.3 will not
prejudice that Party's rights in respect of any
subsequent breach of this Agreement by the other
Party.
25.3.3 Subject to Clause 25.3.1, any failure by a Party to
enforce any of the provisions of this Agreement, or
any
33
forbearance, delay or indulgence granted by a Party
to another Party, will not be construed as a waiver
of that Party's rights pursuant to this Agreement.
25.4 ENTIRE AGREEMENT
This Agreement constitutes the entire agreement between the
Parties with respect to the subject matter of this Agreement
and supersedes all previous negotiations, commitments,
representations and agreements between the Parties.
25.5 COUNTERPARTS
This Agreement may be signed in counterparts and all
counterparts taken together constitute one document.
25.6 AMENDMENTS
This Agreement may be amended only by a written document
signed by both Parties.
25.7 SUCCESSORS AND ASSIGNS
This Agreement will be binding on and inure to the benefit of
the Parties and their permitted successors and assigns:
25.8 ASSIGNMENT
Neither Party may assign any of its rights or obligations
under this Agreement without the prior written consent of the
other Party, except as incident to the merger, consolidation,
reorganization or acquisition of stock or assets affecting all
or substantially all of the assets or actual voting control of
the assigning Party to which this Agreement pertains.
25.9 ATTORNEYS
Each attorney executing this Agreement on behalf of a Party
acknowledges that it has not received notice of the revocation
of the powers of attorney under which it executes this
Agreement.
25.10 FURTHER ASSURANCES
Each Party must do or cause to be done, all things reasonably
required by notice from another Party to give full effect to
this Agreement and each of the transactions contemplated by
this Agreement.
34
26 GOVERNING LAW AND JURISDICTION
26.1 GOVERNING LAW
This Agreement is governed by and is to be
interpreted under the laws of Victoria.
26.2 JURISDICTION
The Parties irrevocably and unconditionally:
26.2.1 submit to the non-exclusive jurisdiction of
the courts of Victoria; and
26.2.2 waive any claim or objection based on
absence of jurisdiction or inconvenient
forum.
26.3 SERVICE OF PROCESS
A document required to be served in proceedings about
this Agreement may be served:
26.3.1 by being delivered to or left at its address
for service of notices under Clause 24; or
26.3.2 in any other way permitted by law.
35
EXECUTED AS AN AGREEMENT
Signed for and on behalf of CERYLID PTY )
LTD (ABN 92 061 632 684) by a duly )
authorised officer: )
/s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Signature
-----------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Name (Print)
C.E.O. Position
Signed for and on behalf of THE )
CUSTOMER by a duly authorised officer: )
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Signature
-----------------------------------------
▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Name (Print)
Vice President Position
SCHEDULE 1
ITEM 1
Date:
ITEM 2
Parties: 1. Cerylid Pty Ltd (ABN 92 061 632 684) ("Cerylid")
2. Anadys Pharmaceuticals Inc. ("Anadys")
ITEM 3
Access Fee: $[...***...]
ITEM 4
Field: With the exception of Screens designed to identify
compounds with antibacterial activity or otherwise
active against bacterial targets, which is expressly
forbidden by an existing contractual arrangement
between Cerylid and a Third Party, Anadys may screen
the Sample Extracts against any other targets for any
other therapeutic indication. If during the Term, the
existing contractual relationship between Cerylid and
such Third Party is amended or terminated so as to no
longer prohibit Cerylid from authorising Anadys to
conduct screens against antibacterial targets, Cerylid
will negotiate in good faith with Anadys to develop an
arrangement acceptable to the Parties that authorises
Anadys to conduct screens against antibacterial
targets.
ITEM 5
Assessment Period: [...***...]
ITEM 6
Evaluation Period: [...***...]
ITEM 7
Dereplication Fee: $[...***...]
Characterisation Fee: $[...***...]
***CONFIDENTIAL TREATMENT REQUESTED
ITEM 8
Evaluation Compound
Fee: No fee in respect of the first [...***...] Identified
Compounds nominated by Anadys as Evaluation Compounds,
and $[...***...] for the [...***...] and each
subsequent Identified Compound so nominated
ITEM 9
Sample Extracts: [...***...]
ITEM 10
Dereplication: Up to [...***...] Hit Extracts per Screen conducted
by Anadys
ITEM 11
Characterisation: Up to [...***...] Priority Hit Extracts per Screen
conducted by Anadys
ITEM 12
Number of Management
Committee Representatives: 6
ITEM 13
Licence Fee: $[...***...] for each compound
ITEM 14
Notices: ANADYS
Address: ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Fax: [...***...]
E-mail: ▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇ ▇▇▇▇▇▇
***CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 2
Research Plan
SCREENING COLLABORATION BETWEEN CERYLID PTY LTD AND ANADYS
PHARMACEUTICALS, INC
6 JUNE, 2002
THIS RESEARCH PLAN IS INTENDED AS A GUIDANCE DOCUMENT ONLY. IN THE EVENT THAT
ANY STATEMENTS CONTAINED WITHIN THIS RESEARCH PLAN CONFLICT WITH ANY TERMS OF
THE AGREEMENT, THE TERMS OF THE AGREEMENT SHALL CONTROL. REFERENCES HEREIN TO
"CLAUSES" REFER TO CLAUSES OF THE AGREEMENT. CAPITALIZED TERMS USED BUT NOT
DEFINED HEREIN SHALL HAVE THE MEANINGS GIVEN TO THEM IN THE AGREEMENT.
1. Provision of Sample Extracts (Cerylid)
- Cerylid will supply Anadys with an agreed set of at least [...***...]
samples from its library of microbIaL fermentation extracts (Sample
Extracts) for testing at Anadys in the selected screens. If agreed to
by Anadys, the Sample Extracts may also include some plant extracts.
The precise breakdown of the sample set will be defined by mutual
agreement but, for indicative purposes, it is anticipated that the set
will include extracts of taxonomically-diverse microbial isolates
(actinomycetes, fungi and eubacteria) sourced from a diverse range of
marine, terrestrial and Antarctic environments and microhabitats, and
fermented under diverse conditions (combination of different growth
media and different physical conditions, eg shaken liquid, static
liquid and solid substrate fermentations). Cerylid will provide
Analysis with a written statement detailing its proposal for sample
selection, prior to dispatch of the Sample Extracts.
2. Primary Screening (Anadys)
- Anadys will conduct primary screening of the Sample Extracts against
its target(s). Responsibility for nominating targets, and for
developing and running primary screens, will reside with Anadys.
3. REPORT OF DATA (ANADYS)
***CONFIDENTIAL TREATMENT REQUESTED
- Anadys will provide Cerylid with a list of all Extracts in which
bioactivity has been confirmed by retest including information on the
number of hits against each particular target.
- If, based on the data and upon consultation with Cerylid, Anadys
determines, that the target initially selected for the Screen should
not continue to Dereplication and with the subsequent steps of the
Research Plan, then Anadys shall so inform Cerylid, and shall designate
a second target to initiate through the Research Plan, commencing with
Step 2 above.
4. DEREPLICATION - STEP 1 - SPE FRACTIONATION (CERYLID)
- Cerylid will conduct crude fractionation of hits by solid phase
extraction (SPE) chromatography (yielding ten fractions from each
parent extract) to localise bioactivities to specific polarity ranges.
5. SHIPMENT OF FRACTIONS (CERYLID)
- Cerylid will ship fractions resulting from the SPE Fractionation
process to Anadys
6. ASSAY DEVELOPMENT (ANADYS)
- Anadys will assay the fractions to localise bioactivities
7. REPORT OF DATA (ANADYS)
- Anadys will report Anadys Screening Data to Cerylid
8. DEREPLICATION - STEP 2 - HPLC FRACTIONATION (CERYLID)
- Cerylid will conduct HPLC Fractionation using gradients tailored to the
relevant polarity ranges in which bioactivities are localised, yielding
forty to eighty fractions per parent extract in which active compounds
will be in Substantially Pure form.
9. SHIPMENT OF FRACTIONS (CERYLID)
- Cerylid will ship fractions resulting from the HPLC Fractionation
process to Anadys
10. SECONDARY ASSAY DEVELOPMENT (ANADYS)
- At its discretion, Anadys may develop and use secondary assays to
eliminate and/or prioritise hits identified in the Screen
11. ASSAY DEVELOPMENT (ANADYS)
- Anadys will assay the fractions to localise bioactivities
12. LC/MS ANALYSIS (ANADYS)
- For selected HPLC fractions showing bioactivity, as determined by
Anadys, Anadys may conduct an LC/MS analysis to help prioritize hits
for structure determination.
- Cerylid and Anadys will jointly use the resultant package of data on
Substantially-Pure active fractions (chromatographic, physicochemical,
LC/MS and biological activity) to prioritise hit extracts for full
chemical isolation and characterisation, with ultimate decisionmaking
authority as to which hits are pursued into structure determination
residing with Anadys.
13. PURIFY AND STRUCTURE DETERMINATION (CERYLID)
- Cerylid will purify active compounds from prioritised hits (supported
by bioassays conducted at Anadys) and elucidate their chemical
structures. The number of such hits taken to characterisation of
compound structures will be up to [...***...] for each specific target
screened at Anadys.
14. PROVISION OF 10mg PURE IDENTIFIED COMPOUND AND FINAL REPORT (CERYLID)
- At the request of Anadys, Cerylid will provide Anadys with a sample of
each Identified compound in sufficient quantity (typically [...***...]
mg) to carry out basic biological and chemical characterizatiON.
***CONFIDENTIAL TREATMENT REQUESTED
