1
--------------------------------
Dated 1997
DIAGNOSTIC DEVELOPMENT AND
COMMERCIALISATION AGREEMENT
BIOTA SCIENTIFIC MANAGEMENT PTY LTD ("BIOTA")
AND
BIOSTAR, INC. ("BIOSTAR")
MALLESONS STEPHEN JAQUES
SOLICITORS
RIALTO
525 COLLINS STREET
MELBOURNE VIC 3000
TELEPHONE (03) 9619 0619
FAX (03) 9614 1329
DX I01 MELBOURNE
REF: D NICHOLSON
MEL_CORP/0050360.01
* CERTAIN CONFIDENTIAL MATERIAL CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
406 OF THE SECURITIES ACT OF 1933, AS AMENDED
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TABLE OF CONTENTS
PAGE
1. INTERPRETATION...........................................................................................2
2. DEVELOPMENT PROJECT......................................................................................9
3. FUNDING OF DEVELOPMENT PROJECT..........................................................................10
4. FDA CLEARANCE...........................................................................................11
5. MANUFACTURE OF DIAGNOSTIC...............................................................................11
6. SUPPLY OF COMPOUNDS.....................................................................................15
7. MARKETING, SALE AND DISTRIBUTION OF DIAGNOSTIC..........................................................15
8. MARKETING/TRADE DRESS...................................................................................17
9. SECOND GENERATION DIAGNOSTIC............................................................................18
10. PROFITS.................................................................................................18
11. BIOTA IP................................................................................................19
12. FOREGROUND IP...........................................................................................21
13. BIOSTAR IP..............................................................................................22
14. PUBLICATION OF DEVELOPMENT PROJECT RESULTS AND OTHER INFORMATION........................................24
15. CONFIDENTIALITY.........................................................................................24
16. TERM AND TERMINATION....................................................................................26
17. INDEMNITY...............................................................................................28
18. FURTHER COLLABORATION...................................................................................29
19. TAXATION................................................................................................29
20. RELATIONSHIP OF PARTIES.................................................................................30
21. NOTICES.................................................................................................30
22. ASSIGNMENT..............................................................................................31
23. WAIVER AND VARIATION....................................................................................31
24. REMEDIES CUMULATIVE.....................................................................................31
25. FURTHER ASSURANCES......................................................................................31
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26. SUPERVENING LEGISLATION.................................................................................32
27. SEVERABILITY............................................................................................32
28. ENTIRE AGREEMENT........................................................................................32
29. GOVERNING LAW...........................................................................................32
30. ARBITRATION OF PAYMENTS.................................................................................32
31. PUBLICITY...............................................................................................33
SCHEDULE 1.......................................................................................................34
SCHEDULE 2.......................................................................................................38
SCHEDULE 3.......................................................................................................40
SCHEDULE 4.......................................................................................................44
SCHEDULE 5.......................................................................................................45
SCHEDULE 6.......................................................................................................46
SCHEDULE 7.......................................................................................................47
SCHEDULE 8.......................................................................................................49
SCHEDULE 9.......................................................................................................50
ii.
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DIAGNOSTIC DEVELOPMENT AND
COMMERCIALISATION AGREEMENT
DATE: This Agreement is made on 23 May, 1997.
PARTIES: BIOTA SCIENTIFIC MANAGEMENT PTY LTD a company incorporated in the
State of Victoria and having its registered office at Level 4,
616 St. Kilda Road, Melbourne, Victoria, Australia ("Biota").
BIOSTAR, INC. a company incorporated in the State of Delaware,
United States of America, and having its principal place of
business at 6655 Lookout Road, Boulder, Colorado 80301, United
States of America ("BioStar").
RECITALS: A. Biota possesses skill and expertise and has information in
relation to influenza treatment and diagnosis, structure
based anti-viral drug design and discovery, Compounds
(defined in clause 1.1) and related chemistries having
diagnostic and therapeutic applications and other Biota
business, financial and technical activities.
B. BioStar possesses skill and expertise in the development,
manufacturing, commercialization and marketing of diagnostic
products and has information in relation to technologies
with diagnostic applications for point of care use, in
particular its Optical Immunoassay Technology (defined in
clause 1.1) and antibody know-how.
C. Biota and BioStar entered into a Diagnostic Project Research
Agreement as of 9 September 1996 (the "Diagnostic Project
Research Agreement") pursuant to which the parties agreed to
collaborate in carrying out a project to determine whether
BioStar's proprietary technologies with diagnostic
applications could be used in conjunction with the Compounds
and Biota's proprietary chemistries for the detection of
influenza (the "Project").
D. The goals of the Project described in schedule 1 of the
Diagnostic Project Research Agreement have been met and
Biota now wishes to further develop and commercialize a
Diagnostic in accordance with the goals and specifications
set out in schedule 3.
E. The parties have agreed to collaborate in carrying out a
Development Project to further develop the Diagnostic and in
the event of the success of that work to commercialize the
Diagnostic in accordance with the terms and conditions of
this Agreement.
1.
5
OPERATIVE PROVISIONS
1. INTERPRETATION
1.1 In this Agreement, unless a contrary intention appears:
AGREEMENT means this agreement including the recitals, schedules and
annexures attached hereto, which are deemed to be incorporated into this
agreement.
ANTIBODY means any antibody developed or used in the course of carrying out
the Project or the Development Project which could be used in the capture or
detection of the influenza virus.
BIOSTAR DISTRIBUTION ALLOWANCE means a percentage of BioStar's Gross Sales
Revenue calculated in accordance with Schedule 7.
BIOSTAR IP means any and all Intellectual Property:
(a) disclosed by BioStar to Biota in the course of the Project,
the Development Project or the manufacture, sale or distribution of the
Diagnostic; or
(b) owned by BioStar or licensed to BioStar which BioStar
disclosed to Biota for the purposes of the Project or discloses to Biota for the
purposes of the Development Project or for the manufacture, sale or distribution
of the Diagnostic, including BioStar's Optical Immunoassay Technology and
antibody know-how; or
(c) created, discovered or coming into existence or arising as a
result of the Project, the Development Project or in connection with the
manufacture, sale or distribution of the Diagnostic; or
(d) learned by Biota or BioStar in the course of carrying out the
Project or the Development Project or in connection with the manufacture, sale
or distribution of the Diagnostic,
provided that, in the case of paragraphs (c) and (d), the Intellectual Property
is related directly to BioStar's Optical Immunoassay Technology or an antibody
approach to a diagnostic not incorporating a Compound or a Compound conjugate or
combination and not constituting Project IP (as defined under the Diagnostic
Project Research Agreement) or Foreground IP.
BIOTA DISTRIBUTION ALLOWANCE means a percentage of Biota's Gross Sales
Revenue relating to the sale of the Diagnostic in the US calculated in
accordance with Schedule 7.
BIOTA GROUP means Biota Holdings Limited and any of its subsidiaries (as
defined in Division 6 of Part 1.2 of the Corporations Law).
2.
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BIOTA IP means any and all Intellectual Property:
(a) disclosed by Biota to BioStar in the course of carrying out
the Project, the Development Project or the manufacture, sale or distribution of
the Diagnostic;
(b) owned by Biota or licensed to Biota which Biota brought to
the Project or brings to the Development Project or discloses to BioStar for use
in the manufacture, sale or distribution of the Diagnostic; or
(c) constituting Project IP.
BREACH DATE has the meaning given in clause 5.5.
COMMERCIALIZATION PLAN means a plan for the commercialization of the
Diagnostic in the form set out in Schedule 8.
COMPOUND-BASED ASSAY means an assay incorporating a Compound or Compounds.
COMPOUNDS means those compounds listed in Schedule 4 and any compounds
specific for influenza detection:
(a) synthesized or produced in the course of carrying out the
Project or the Development Project;
(b) brought to the Project or the Development Project by Biota
either at the start or during the course of the Project or the Development
Project; or
(c) resulting from modifications or changes to any such
compounds, but does not include antibodies or antibody like molecules unless
such antibodies or antibody like molecules are combined or conjugated with such
compounds.
CONFIDENTIAL INFORMATION of a Disclosing Party means any information and
know-how including Biota IP, BioStar IP or Foreground IP, as the case may be,
(except information described in clause 15.2):
(a) disclosed by the Disclosing Party to the Disclosee;
(b) learned by the Disclosee as a result of or in relation to the
Project, Development Project or the manufacture, sale or distribution of the
Diagnostic; or
(c) concerning this Agreement (including the terms of this
Agreement), the Diagnostic Project Research Agreement or any other agreement
executed or proposed between the parties or the negotiations between the parties
3.
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relating to this Agreement or any such other agreement.
CORPORATIONS LAW means the Corporations Law of the State of Victoria,
Australia.
COST OF GOODS includes all costs directly incurred by a party in producing
goods (Diagnostic or Compounds, as the case may be) including the cost of raw
materials (including GG167 chemicals), actual cost of all direct labor and any
administrative costs related to such manufacture, such administrative costs to
be determined in a manner which is consistent with generally accepted Australian
accounting principles.
DEVELOPMENT BUDGET means the budget for the Development Project set out in
Schedule 2, as varied from time to time by mutual agreement of the parties under
clause 3.2.
DEVELOPMENT PROJECT means the collaborative project which is to be
undertaken by the parties as described in Recital E and the Development Work
Plan.
DEVELOPMENT WORK PLAN means the work plan for the Development Project set
out in Schedule 1, as varied from time to time by mutual agreement of the
parties under clause 2.1.
DIAGNOSTIC means a device or procedure which incorporates one or more
Compounds, Antibodies, Antibody-like molecules or Ligands for use in, or in
connection with diagnosing viral influenza.
DIAGNOSTIC PATENTS means any Patent or Patent Applications now or hereafter
applied for, granted to or made by Biota or BioStar in respect of the Diagnostic
or the Intellectual Property in the Diagnostic and any continuations,
continuations in part division, registrations, confirmations, re-issues,
renewals or extensions of term thereof.
DIAGNOSTIC PROJECT RESEARCH AGREEMENT means the agreement described as such
in recital C.
DISCLOSEE means the party to whom Confidential Information or Intellectual
Property is disclosed or the party which learns the relevant Confidential
Information from the other party.
DISCLOSING PARTY means the party which discloses Confidential Information
or Intellectual Property to the other party or from whom information is learned
directly or indirectly.
DISTRIBUTION ALLOWANCE means the Biota Distribution Allowance or the
BioStar Distribution Allowance, as relevant.
DUE DATE has the meaning given in clause 5.4.
4.
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FDA means the Food and Drug Administration of the US (or any replacement or
successor body).
FDA CLEARANCE OF THE DIAGNOSTIC means formal FDA clearance of the sale and
use of the Diagnostic for the diagnosis of influenza in the US.
FDA APPROVAL OF GG167 means formal FDA approval to the use of the compound
GG167 (Zanamivir) for therapeutic purposes in the treatment of influenza in the
US.
FORCE MAJEURE means acts of gods, fire, lightening, explosions, flood,
subsidence, insurrection or civil disorder or military operations; government
restraint, expropriation, prohibition, intervention, direction or embargo.
FOREGROUND IP means any and all Intellectual Property:
(a) created, discovered, coming into existence or arising from
the carrying out of the Development Project or the manufacture, sale or
distribution of the Diagnostic; or
(b) learned by Biota or BioStar from the Development Project,
(including the results of any evaluation or testing carried out pursuant to the
Development Project) or the manufacture, sale or distribution of the Diagnostic,
including without limitation, any and all Intellectual Property which:
(c) relates to the structure, manufacture, use, synthesis or
properties of Compounds or combinations or conjugates of Compounds;
(d) relates to the therapeutic or diagnostic application of
Compounds or combinations or conjugates of Compounds; or
(e) is derived directly or indirectly from the use or application
of Glaxo IP; but excluding any and all Intellectual Property which directly
relates to BioStar IP.
[ *
]
GLAXO GROUP means any or all of Glaxo Wellcome plc, Glaxo Group Limited,
Glaxo Wellcome Australia Ltd, Glaxo Research and Development Limited and their
related bodies corporate from time to time.
GLAXO IP means any and all Intellectual Property owned or possessed by
Glaxo Group which Glaxo Group has disclosed or discloses to the Biota Group or
BioStar for the purposes of, or in the course of the
5.
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Project or the Development Project or the manufacture, sale or distribution of
the Diagnostic.
GROSS SALES REVENUE means all amounts or revenue received, receivable or
derived by a party from the sale of the Diagnostic to a third party, provided
that for these purposes any sales not made in an arms length, bona fide,
commercial transaction will be deemed to have been at the standard commercial
price list rates of the selling party for the Diagnostic, or, if none, at the
fair market price.
INDEPENDENT AUDITOR means the person appointed as auditor jointly by Biota
and BioStar for the purposes of clause 10.6 or if they do not agree on the
person to be appointed within 7 days of the end of the first Sales Year, the
accountant appointed by the President of the Australian Institute of Chartered
Accountants (Victorian Branch) at the request of either Biota or BioStar.
INTELLECTUAL PROPERTY includes:
(a) inventions, patents, copyright works and other subject
matter, trade dress, designs, trade marks, trade names, logos and get up,
circuit layouts, business or marketing plans, trade secrets and confidential
information;
(b) ideas, concepts, processes, techniques, software products and
know-how; and
(c) all rights conferred under statute, common law and equity in
and in relation to any of the above.
LIBOR means:
(a) if not less than two rates for 90 day loans are displayed on
Reuters page "LIBO" at or around 11:00 am (London time) on the business day
before the day on which this Agreement terminates under clause 16.4, the
arithmetic mean (expressed as a rate per cent per annum and rounded up to five
decimal places) of not less than two of those rates selected by Biota; or
(b) if Biota is unable to determine a rate under paragraph (a)
because an insufficient number of rates are displayed, the rate (expressed as a
rate per cent per annum and rounded up to three decimal places) specified in
good faith by Biota at or around that time having regard, to the extent
possible, to the offer rates otherwise quoted to Biota for loans equal to the
amount due over a 90 day period at or around that time;
LIGAND means any atom, ion or molecule that can complex with a target
molecule and is capable of being detected.
6.
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MINIMUM SALES VOLUME means the minimum sales volume of Diagnostic to be
achieved by BioStar during the term of this Agreement as set out in Schedule 6.
OPERATING MARGIN of a party means all Gross Sales Revenue of that party
less:
(a) the Cost of Goods of that party, provided that for these
purposes any sales not made in an arms length, bona fide, commercial transaction
will be deemed to have been at the standard commercial price list rates for the
Diagnostic, or, if none, at the fair market price; and
(b) any Distribution Allowance to which the relevant party is
entitled.
OPTICAL LIMMUNOASSAY TECHNOLOGY means the optical immunoassay technology
described in Schedule 5.
PARTIES means Biota and BioStar and PARTY means one or both of the parties
as the context requires.
PATENT means a patent as defined in the Patents Act 1990 (Cth) and any
national or regional patent within the terms of the Patent Co-operation Treaty
and includes any re-issue, renewal or extension of a patent (whether in whole or
in part) and any patent of addition or any substantially similar form of
protection for inventions granted in any country, the essence of which is a
right in the holder of such form of protection to exclude others from making,
using or selling products or processes, the subject matter of the said
invention.
PATENT APPLICATIONS means any patent application as defined in the Patents
Act 1990 (Cth) and any national, regional or international application within
the terms of the Patent Co-operation Treaty and includes any continuation,
continuation in part, division, re-issue or substitution of a patent application
or application for any substantially similar form of protection for inventions
granted by any country, the essence of which is a right in the holder of such
form of protection to exclude others from making, using or selling products or
processes, the subject matter of the said invention.
PERMITTED PURPOSES means for the purposes of:
(i) carrying out the Development Project; or
(ii) the manufacture, sale or distribution of the Diagnostic,
pursuant to this Agreement.
PERSONNEL of a party includes its officers, directors, employees, agents,
consultants or contractors.
7.
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PRESCRIBED TERMS means terms, conditions and warranties implied by law into
some contracts for the supply of goods or services which the law expressly
provides may not be excluded, restricted or modified, or may be excluded,
restricted or modified only to a limited extent.
PROJECT has the meaning given in Recital C.
PROJECT IP means any and all Intellectual Property:
(a) created, discovered coming into existence or arising from the
carrying out of the Project; or
(b) learned by Biota or BioStar from the Project, including the
results of any evaluation or testing carried out pursuant to the Project,
and not relating directly to BioStar IP but without limitation, includes any and
all Intellectual Property which:
(c) relates to the structure, manufacture, use, synthesis or
properties of Compounds or combinations or conjugates of Compounds;
(d) relates to the therapeutic or diagnostic application of
Compounds or combinations or conjugates of Compounds; and
(e) is derived directly or indirectly from the use or application
of Glaxo IP.
RELATED BODY CORPORATE has the meaning given in section 9 of the
Corporations Law.
SALES YEAR means a 12 calendar month period during the term of this
agreement in respect of which BioStar must achieve a Minimum Sales Volume in
accordance with clause 7.1 and Schedule 6. If sales start (that is product is
shipped) during a calendar month, the first Sales Year shall commence on the 1st
day of the subsequent month.
SECOND GENERATION DIAGNOSTIC means a Diagnostic incorporating technology
which is not Optical Immunoassay Technology and includes any technology licensed
or otherwise made available to BioStar or a Related Body Corporate of BioStar.
SPECIFICATIONS means the specifications and performance criteria for the
Diagnostic set out in Schedule 3.
TAXES means any and all present and future sales, use, personal property,
real property, value added, turnover, stamp, documentary, interest equalization,
business, occupation, excise, income, corporation, profits, gains, gross
receipts, or other taxes, fees, withholdings, imposts, levies, duties or other
charges of any nature whatsoever or whensoever imposed, together with any
penalties, fines or interest
8.
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thereon or similar additions thereto, imposed, levied or assessed or otherwise
payable.
TERRITORY means the following countries: US, Canada, Japan, Australia, New
Zealand and the members forming the European Union.
US means the United States of America.
1.2 Unless the contrary intention appears:
(a) a reference to this Agreement or any other instrument
includes any variation or replacement of either of them which does not supersede
this Agreement in its entirety;
(b) a reference to any thing is a reference to the whole or any
part of it (unless the reference specifically excludes parts of the whole or
specifically references only the part) and a reference to a group of persons is
a reference to any one or more of them (unless the reference specifically refers
to the group as a whole); and (C) where a word or phrase is grammatically
defined in this Agreement any other parts of speech and grammatical forms of
that word or phrase shall have the corresponding meanings.
1.3 Headings are inserted for convenience and do not affect the
interpretation of this Agreement.
1.4 The parties acknowledge that in some respects this Agreement
supersedes the Diagnostic Project Research Agreement and agree therefore that to
the extent of any inconsistency between this Agreement and the Diagnostic
Project Research Agreement, this Agreement shall prevail.
2. DEVELOPMENT PROJECT
2.1 BioStar shall undertake work for the purposes of and in relation
to the Development Project as set out in the Development Work Plan. The parties
may vary or add to the Development Work Plan only by written agreement of both
parties from time to time during the term of the Agreement. The parties agree
that any variation or addition to the Development Work Plan may require an
amendment to the Development Budget.
2.2 BioStar shall use commercially reasonable efforts to ensure that
it has sufficient facilities and qualified Personnel to enable it to comply with
its obligations under this Agreement.
2.3 BioStar shall not enter into any other contract, arrangement or
understanding with any third party or parties in respect of the matters covered
by the Development Project or in relation to, or in any way
9.
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involving Foreground IP without Biota's prior written consent, such consent
not to be unreasonably withheld.
2.4 BioStar shall maintain full and accurate data, information and
records of and concerning its work in relation to the Development Project and
the results of any research studies undertaken by BioStar for the purposes of
the Development Project and must make such data, information and records
available to Biota as and when necessary or as and when requested by Biota.
Biota shall maintain full and accurate data, information and records of and
concerning its work in relation to the Development Project and the results of
any research studies undertaken by Biota for the purposes of the Development
Project and must make such data, information and records available to BioStar as
and when necessary for the purposes of FDA Clearance of the Diagnostic.
2.5 Upon the giving of reasonable advance notice by Biota, BioStar
shall permit Biota and its Personnel to enter the premises of BioStar at all
reasonable times for the purpose of inspecting activities relating to the
Development Project.
2.6 BioStar undertakes to Biota that it shall use all reasonable
efforts to keep Biota informed of, and make available under this Agreement, new
ideas, opportunities, updates in technology (including in Optical Immunoassay
Technology) and technologies relating to Diagnostics and shall agree to
reasonable amendments to the Development Work Plan to take account of the same
from time to time. Biota undertakes to BioStar that it shall use all reasonable
efforts to keep BioStar informed of, and make available under this Agreement,
new ideas, opportunities, updates in technologies relating to Compounds
developed by it and shall agree to reasonable amendments to the Development Work
Plan to take account of the same from time to time.
3. FUNDING OF DEVELOPMENT PROJECT
3.1 Subject to this clause 3, Biota agrees to pay [
* ] in accordance with the Development Budget
for the period up to FDA Clearance of Diagnostic. In the period following the
FDA Clearance of the Diagnostic, the parties agree to negotiate in good faith in
relation to costs in undertaking further research and development in relation to
Diagnostics.
3.2 The parties may vary or add to the Development Budget by written
agreement of the parties from time to time during the term of the Agreement.
3.3 BioStar agrees to use commercially reasonable efforts to conduct
the Development Project in accordance with the Development Work Plan and
Development Budget.
10.
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4. FDA CLEARANCE
4.1 BioStar shall use commercially reasonable efforts to obtain FDA
Clearance of a Diagnostic. BioStar must prepare an application for FDA Clearance
of a Diagnostic in accordance with the Development Work Plan and shall provide
Biota with a draft application and all relevant materials for submission as part
of the application to the FDA in relation to the Diagnostic as soon as possible.
BioStar must obtain Biota's prior written consent before lodging any original
application for FDA Clearance such consent not to be unreasonably withheld.
4.2 Biota undertakes to review promptly any application for FDA
Clearance submitted to it by BioStar, whether provided in whole or in part. In
the event Biota fails to respond to BioStar within 30 days' after receiving any
such materials Biota shall be deemed to have approved those materials.
4.3 Following submission of an application for FDA Clearance of the
Diagnostic, BioStar must make all reasonable efforts to discuss the provision of
any additional information to the FDA and must promptly make available to Biota
copies and details of all information used or provided to FDA for the purposes
of obtaining FDA Clearance of the Diagnostic, including records of conversations
with the FDA and correspondence from or other information provided by or to the
FDA, and must keep Biota fully informed of progress of the application for FDA
Clearance of the Diagnostic. BioStar must use all reasonable efforts to maintain
the confidentiality of any information containing or relating to Foreground IP
or Biota IP and must request confidential treatment of the same by the FDA.
4.4 Biota agrees to pay BioStar the sum of [ * ] within 30 days
after the grant of FDA Clearance of the Diagnostic.
4.5 BioStar shall provide Biota with such assistance (including
executing documentation and assignments) as may be reasonably required by Biota
to obtain regulatory approval to the use of the Diagnostic in the diagnosis of
influenza in countries other than the US.
4.6 If FDA Clearance of a Diagnostic is obtained, BioStar shall
immediately notify Biota and provide Biota with copies of the FDA Clearance of
the relevant Diagnostic and any associated materials.
4.7 In addition to any other specific obligations under this
Agreement, each party agrees with the other that it will comply with all
applicable legislation, regulations and governmental requirements insofar as the
same apply to it in the manufacture, use or sale of the Diagnostic.
5. MANUFACTURE OF DIAGNOSTIC
5.1 At the time that a [ *
], BioStar must also
11.
15
provide Biota with a draft Commercialization Plan for the Diagnostic for Biota's
review and discussion with BioStar. BioStar must use all reasonable efforts to
implement a mutually agreeable Commercialization Plan.
5.2 Biota hereby grants to BioStar effective upon, and subject to,
Biota's approval of the FDA Application as set forth in clause 4.2 above, for
the term of this Agreement, a sole and exclusive, world-wide license of Project
IP and Foreground IP for the purposes of manufacturing the Diagnostic for the
purposes of the sale and distribution of the Diagnostic by Biota or BioStar
pursuant to this Agreement provided that:
(i) the Diagnostic manufactured by BioStar conforms with the
Specifications;
(ii) BioStar is able to and does supply Biota with such quantity
of Diagnostic as may be required by Biota from time to time; and
(iii) BioStar's manufacture of the Diagnostic materially complies
with all relevant legislation and regulations in the Territory, including the
FDA's Good Manufacturing Practice and other applicable regulations.
5.3 For the purposes of clause 5.2(i) or (ii), BioStar shall not be
taken to have failed to supply Biota with Diagnostic where:
(a) Biota has failed to supply BioStar with requisite quantities
of Compounds used in such Diagnostic or has supplied BioStar with defective
Compounds; or
(b) the failure to supply is remedied within 60 days of the date
on which delivery of the relevant quantity of Diagnostic was due.
5.4 In the event that BioStar fails to supply Biota with Diagnostic
as required under clause 5.2(i) or (ii):
(a) BioStar must pay [ * ] to Biota within 14 days of the
date being 60 days after the date on which the delivery of the relevant quantity
of Diagnostic or conforming Diagnostic was due;
(b) thereafter, not less than [*] of Diagnostic manufactured by
BioStar from time to time must be applied by BioStar in fulfilling Biota's
orders, unless otherwise agreed by the parties in writing; and
(c) BioStar must fully meet Biota's requirements for Diagnostic
within 6 months of the date ("Due Date") being 60 days after the date on which
the delivery of the relevant quantity of Diagnostic or conforming Diagnostic was
due but not supplied.
12.
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This clause 5.4 shall only apply to the first breach by BioStar of clause
5.2(i) or (ii). For the avoidance of doubt, the parties acknowledge that in the
event BioStar fails to supply Biota with Diagnostic as required under clause
5.2(i) or (ii) at any time after the date being 6 months after the Due Date,
BioStar shall be in breach of its obligations under this Agreement.
5.5 For the purposes of clause 5.2(iii), BioStar shall not be taken
to have failed to materially comply with relevant legislation or regulations in
the Territory including the FDA's Good Manufacturing Practice and other
applicable regulations, where:
(a) BioStar rectifies the relevant failure; or
(b) BioStar is able to, and does, supply Diagnostic in compliance
with clause 5.2(iii) from an alternative BioStar manufacturing facility;
within 60 days of the date on which the failure first occurred. Any failure that
is not remedied within this time period shall be deemed for the purposes of this
agreement to have occurred on the day being 60 days after the date on which the
failure first occurred ("Breach Date").
5.6 In the event BioStar fails to comply with clause 5.2(iii):
(a) if no amount has been paid to Biota in accordance with clause
5.4(a), BioStar must pay [ * ] to Biota within 14 days of the Breach Date;
and
(b) BioStar must fully rectify the failure to Biota's reasonable
satisfaction within 6 months after the Breach Date; This clause 5.6 shall only
apply to the first failure by BioStar to comply with clause 5.2(iii), unless
otherwise agreed by the parties.
5.7 As soon as BioStar becomes aware that there has been a breach of
either clause 5.2(i) or 5.2(ii) it must promptly advise Biota in writing of the
full details of the breach.
5.8 In the event that BioStar's failure to supply Biota with
Diagnostic under clause 5.2(ii) was caused by an event of Force Majeure,
BioStar's license shall only be suspended and shall recommence when the relevant
event of Force Majeure ceases or is removed, provided that if BioStar is
affected by an event of Force Majeure it must give Biota details of the event of
Force Majeure as soon as practicable and must forthwith take all reasonable
steps to remove or mitigate the relevant event of Force Majeure and BioStar
keeps Biota fully informed of its progress in relation to the same.
13.
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5.9 In order to assist BioStar in meeting Biota's requirements for
the Diagnostic, Biota shall provide BioStar with an annual forecast and monthly
updates of its requirements for Diagnostic, the first 90 days of which shall be
considered a purchase order.
5.10 Biota must place a purchase order with BioStar for any Diagnostic
required by it and BioStar must supply Diagnostic ordered pursuant to such
purchase orders within 90 days of receipt of such order by delivery to the place
specified in the relevant purchase order, provided that:
(a) Biota may amend any purchase order by up to [*] (plus or
minus) of the ordered quantity at any time in the 45 days immediately following
the date of the purchase order;
(b) BioStar must use its best efforts to meet any amendment in
excess of [*] (plus or minus) of the ordered quantity made within the same time
period at no cost to Biota; and
(c) at any time during the first 6 months following the date on
which Diagnostic is first supplied to Biota, Biota may cancel any purchase order
provided that it reimburses BioStar for [*] of BioStar's costs (or [* ] if
notice of the cancellation is given later than 45 days after the date of the
purchase order) incurred in filling the relevant purchase order prior to receipt
of notice of cancellation.
5.11 If the parties so agree in writing, prior to receipt of FDA
Clearance of the Diagnostic, either party may sell Diagnostic for research
purposes only, subject to compliance with all applicable laws. For this purpose
only the licenses granted under clauses 5.2 and 7.1 shall be deemed to be
effective from the time of agreement of the parties to the research sales. Sales
of Diagnostic for research purposes shall not constitute sales for the purposes
of calculating the Minimum Sales Volume under clause 10 and the license granted
under this clause shall not be subject to meeting any sales volumes, but clause
10 shall otherwise apply to receipts from such sales.
5.12 BioStar must use all reasonable commercial efforts to produce the
Diagnostic as efficiently and at as low a cost as possible consistent with the
FDA's Good Manufacturing Practice and other applicable regulations.
5.13 BioStar must provide Biota with annual forecasts of Cost of Goods
based on reasonable commercial efforts to accurately forecast such cost.
5.14 Biota agrees to pay BioStar an amount equal to [
* ] for the supply of Diagnostic to
Biota within 30 days of invoice for the same, invoices not to be provided more
frequently than monthly.
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5.15 All Diagnostic supplied to Biota by BioStar shall be shipped ex
works BioStar's facilities in Boulder, Colorado (Incoterms 1990) to a port or
ports nominated by Biota, provided that Biota shall pay all reasonable shipping
costs.
5.16 Without limiting clause 17, BioStar agrees to take out and
maintain during the term of this Agreement and any period thereafter in which it
is manufacturing Diagnostic or sales or use of the Diagnostic are continuing in
any country adequate product liability insurance in respect of Diagnostic
manufactured by BioStar and covering liability to the value of [ * ].
5.17 BioStar agrees to provide Biota with such technical assistance
as may be reasonably required by Biota from time to time in connection with the
manufacture of the Diagnostic, after sales assistance and other matters arising
in connection with the manufacture (subject to clause 5.2), sale and
distribution of the Diagnostic at Biota's expense.
6. SUPPLY OF COMPOUNDS
6.1 Biota agrees to sell and BioStar agrees to exclusively purchase
from Biota such quantity of Compounds as may be required by BioStar for the
purposes of manufacturing the Diagnostic under clause 5.2. Biota must use all
reasonable commercial efforts to produce any Compounds used in the Diagnostic as
efficiently and at as low a cost as possible consistent with good manufacturing
practice and other applicable regulations.
6.2 BioStar agrees to pay Biota an amount equal to [
* ] for the supply of Compounds to BioStar
under clause 6.1 within 30 days of invoice for the same, invoices not to be
provided more frequently than monthly.
7. MARKETING, SALE AND DISTRIBUTION OF DIAGNOSTIC
7.1 Biota hereby grants to BioStar effective upon, and subject to
Biota's written approval of the application for FDA Clearance of the Diagnostic
made in accordance with clause 4, a sole and exclusive license for the term of
this Agreement to market, sell and distribute the Diagnostic in the US, subject
to BioStar selling at least the Minimum Sales Volume for each Sales Year.
7.2 If BioStar fails to achieve the Minimum Sales Volume in respect
of any Sales Year during the term of the Agreement, the license granted to
BioStar under clause 7.1 shall become non-exclusive.
7.3 The parties acknowledge that Biota shall have the exclusive right
to market, sell and distribute the Diagnostic outside the US.
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7.4 BioStar hereby grants to Biota a contingent and exclusive (as
set out below), worldwide license to use BioStar IP:
(a) subject to clauses 7.1 and 7.2 for the purposes of the sale
and distribution of the Diagnostic; and
(b) subject to clause 5.2, the manufacture of the Diagnostic;
by Biota.
7.5 Biota agrees to enter into negotiations on behalf of BioStar in
good faith with the Glaxo Group concerning the sale and distribution of the
Diagnostic by the Glaxo Group in the US.
7.6 Subject to agreement by the parties of the terms of any agreement
for the sale of the Diagnostic to the Glaxo Group, Biota and BioStar agree that
any sale of a unit of the
Diagnostic by BioStar to any member of the Glaxo Group for use in the US shall
be treated as a sale of a unit of Diagnostic by BioStar in determining whether
BioStar has achieved the Minimum Sales Volume in any Sales Year for the purposes
of clause 7.1.
7.7 (a) Either party may provide samples to customers provided that
the number of samples of Diagnostic provided is approved by the other party in
writing, such approval not to be unreasonably withheld.
(b) For the purposes of calculating the Minimum Sales Volume for
each Sales Year, provision of samples of the Diagnostic shall be disregarded.
7.8 In the event that BioStar sells the Diagnostic in conjunction
with another of its products or the product of a third party, any discount
applied to such combined sale shall be applied between the products pro rata to
their respective list sales prices.
7.9 Biota agrees to discuss in good faith with BioStar requests by
BioStar relating to the commercialization of the Diagnostic in countries in
which Biota has elected not to commercialize the Diagnostic.
7.10 BioStar undertakes it shall forthwith notify Biota if it intends
to enter into any arrangement for the sale or distribution of the Diagnostic
with a third party who is the manufacturer of a competitive (of either the Biota
Group or Glaxo Group) influenza therapeutic or the product of a third party who
is the manufacturer of a competitive (of either the Biota Group or Glaxo Group)
influenza therapeutic and offer Biota or Biota's nominee the right to enter into
such an arrangement on terms substantially similar to those offered to the third
party. If Biota or its nominee fails to accept such offer within 60 days of
receipt of full details of the offer, BioStar may make the proposed offer to the
party, provided that BioStar must not offer such third parties terms and
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conditions which are more favorable than those offered to Biota without first
offering such alternative terms to Biota.
8. MARKETING/TRADE DRESS
8.1 If requested by BioStar, Biota agrees to seek to obtain the [
* ] from [ * ] for use by BioStar at no cost to BioStar in marketing
the Diagnostic in the US under this Agreement.
8.2 BioStar agrees to use its best endeavors to promote the sale of
the Diagnostic in the US, including if requested to do so by Biota and subject
to any conditions imposed by Glaxo, directly contacting customers on the [
* ].
8.3 BioStar agrees to use telemarketing at its own cost to contact
potential customers who are not located in territories covered by BioStar's Flex
Rep marketing program.
8.4 Biota and BioStar agree to jointly develop labeling, trade dress
and trademarks to be used on or in relation to the Diagnostic in the marketing,
sale and distribution of the Diagnostic in the US under this Agreement.
8.5 (a) Subject to clause 8.5(b) neither party may use any labeling,
trade dress and trademarks on or in relation to the Diagnostic in the marketing,
sale and distribution of the Diagnostic other than that jointly developed by the
parties without the prior written consent of the other party, provided that
BioStar must not unreasonably withhold or delay its consent in relation to the
use of other labeling, trade dress or trademarks by Biota outside the US.
(b) In the event that BioStar fails to achieve the Minimum Sales
Volume in respect of any Sales Year and Biota elects to sell or distribute
Diagnostic in the US, Biota shall not be required to use any of the labeling,
trade dress or trademarks developed under clause 8.4 except to extent required
by the FDA.
8.6 BioStar acknowledges and agrees that Biota shall own all right,
title and interest in and to the Intellectual Property in the labeling,
trademarks or trade dress developed under clause 8.4. To the extent that any
Intellectual Property relating to the labeling, trademarks or trade dress does
not vest in Biota as a result of the foregoing, BioStar undertakes to procure
the assignment of such Intellectual Property to Biota at Biota's cost.
8.7 Biota agrees to grant BioStar an exclusive, royalty free license
to use the said labeling, trademarks or trade dress in relation to the
marketing, sale and distribution of the Diagnostic in the US for the term of
this Agreement in a form to be agreed by the parties.
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9. SECOND GENERATION DIAGNOSTIC
If BioStar develops a Second Generation Diagnostic during the term of this
Agreement, BioStar undertakes it shall forthwith notify Biota and offer Biota
the right to develop and commercialize the Second Generation Diagnostic on terms
substantially similar to those set out in this Agreement. If Biota fails to
accept such offer within [ * ] of receipt of reasonably sufficient details of
the Second Generation Diagnostic, BioStar may offer the commercialization rights
to the Second Generation Diagnostic to third parties, provided that BioStar must
not offer such third parties terms and conditions which are more favorable than
those offered to Biota without first offering such alternative terms to Biota.
10. PROFITS
10.1 Biota and BioStar shall [* ] be entitled to [*] of the Operating
Margin of BioStar relating to the sale of the Diagnostic in the US and BioStar
shall pay Biota accordingly quarterly in arrears as directed by Biota.
10.2 If BioStar fails to achieve the Minimum Sales Volumes in respect
of any Sales Year as required under clause 7.1 and Biota exercises its right to
market, sell and distribute Diagnostic in the US, Biota shall be entitled to
[*], and BioStar shall be entitled to [*] of the aggregate Operating Margin of
Biota and BioStar relating to sales of the Diagnostic in the US and shall pay
each other accordingly quarterly.
10.3 Biota agrees to pay BioStar [*] of the Gross Sales Revenue of
Biota relating to the sale of the Diagnostic throughout the world, excluding the
US during each Sales Year and shall pay BioStar accordingly quarterly.
10.4 Biota and BioStar each agree to jointly appoint the Independent
Auditor and to make their financial records available to the Independent
Auditor:
(i) at the end of each Sales Year; and
(ii) immediately prior to the launch of GG167, if the
Diagnostic has already been launched,
to enable the Independent Auditor to conduct an audit of those records and to
prepare a report concerning the sales volumes of Diagnostic and the amount (if
any) payable by Biota and/or BioStar to each other under this Agreement. The
costs of the Independent Auditor shall be borne equally by the parties and each
party shall ensure that prompt payment of the Independent Auditor's fees is
made.
10.5 The report prepared under clause 10.4 shall include details for
the relevant period of:
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(a) BioStar's Cost of Goods in manufacturing Diagnostic for
supply to Biota under clause 5.1;
(b) Biota's Cost of Goods in manufacturing Compounds for supply
to BioStar under clause 6.2;
(c) the number of units of Diagnostic sold by BioStar to third
parties in the US;
(d) the Operating Margin of each of Biota and BioStar relating to
their sale of Diagnostic;
(e) the Gross Sales Revenue of each of Biota and BioStar relating
to their sale of Diagnostic;
(f) the Biota Distribution Allowance;
(g) the BioStar Distribution Allowance; and
(h) a reconciliation of the amounts (if any) payable by Biota
and/or BioStar to each other under this Agreement during the relevant Sales Year
against the actual payments made.
10.6 As soon as possible after receipt of the Independent Auditor's
report and no later than 30 days after receipt of the same, each party shall
ensure that, if the Independent Auditor's report indicates that there has been a
shortfall, in or overpayment, of any payments required to have been made by that
party under this Agreement, payment of such shortfall is made or the amount of
any overpayment is refunded as the case may be.
11. BIOTA IP
11.1 BioStar shall, and shall ensure that its Personnel shall:
(a) keep all Biota IP confidential;
(b) use Biota IP solely for the Permitted Purposes;
(c) not disclose, without Biota's written consent Biota IP to any
person other than BioStar Personnel to whom disclosure is necessary for any of
the Permitted Purposes, and then only to the extent necessary; and
(d) not to reproduce any of the Biota IP except as necessary for
any of the Permitted Purposes or with the prior permission of Biota; unless
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(e) the relevant Biota IP is in the public domain or becomes part
of the public domain otherwise than as a result of a wrongful act of BioStar,
(f) such intellectual property was not acquired directly or
indirectly from Biota; or
(g) BioStar independently developed the Intellectual Property
without reference to Biota IP and can demonstrate such independent development
through competent written records.
Without limiting the foregoing, BioStar agrees not to disclose any Biota IP to
the FDA without complying with clause 4.
11.2 BioStar acknowledges and agrees that:
(a) it has no rights whatsoever in or in relation to Biota IP
other than to use the Biota IP for the Permitted Purposes;
(b) it will not assert any ownership in respect of the Biota IP
against Biota or any third party from whom Biota may have licensed the Biota IP;
(c) subject to the terms of this Agreement, third parties may
also be granted by Biota rights to use the Biota IP.
11.3 BioStar shall ensure that its Personnel to whom Biota IP may be
disclosed execute a confidentiality undertaking in the form agreed by the
parties.
11.4 BioStar agrees to make all reasonable endeavors to prevent Biota
IP and Glaxo IP from being used for the benefit of any third party other than
Biota or Glaxo (as the case may be), their respective licensees, or third
parties otherwise entitled to use the same.
11.5 Biota shall be responsible for drawing the specifications for,
prosecuting, obtaining and maintaining the Diagnostic Patents (subject to clause
13.5, except to the extent the relevant patent includes only BioStar IP) which
shall be in the name of Biota.
11.6 BioStar shall provide, and shall ensure that its employees or
consultants provide Biota with such assistance as may be reasonably required by
Biota to file, prosecute, obtain or maintain any Diagnostic Patent provided that
Biota shall pay BioStar's actual costs of such consultants.
11.7 Biota represents and warrants to BioStar on the date of this
Agreement and on each date Biota IP is provided to BioStar that to the best of
Biota's knowledge, having made all reasonable enquiries, the Biota IP and any
work undertaken by Biota for the Permitted Purposes does not and will not
infringe the Intellectual Property of any third party.
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11.8 Biota hereby grants BioStar a non-exclusive license under the
Diagnostic Patents and Biota IP to the extent necessary to enable BioStar to
exercise its rights under clauses 5 and 7.
11.9 Biota will promptly and fully inform BioStar in writing of:
(a) any infringement or threatened infringement of Biota's rights
in and to Biota's IP and patents associated with that intellectual property;
(b) any unauthorized use of Biota's IP; or
(c) any challenge or threat of challenge to the grant or validity
of any patent associated with Biota's IP or any part thereof or of Biota's right
to use Biota's IP or any part thereof as contemplated by this Agreement, which
may come to Biota's attention;
to the extent that the same are relevant to the Diagnostic.
12. FOREGROUND IP
12.1 BioStar acknowledges and agrees that all Foreground IP vests in
and is the exclusive property of Biota and save as provided in clause 12.3,
BioStar has no right, title or interest whatsoever in or in relation to
Foreground IP. To the extent that the Foreground IP does not vest in Biota as a
result of the foregoing BioStar undertakes to procure the assignment of such
Foreground IP to Biota and to provide all information, execute all documents and
do all acts and things necessary or desirable to give effect this clause 12.
12.2 BioStar must disclose to Biota all Foreground IP (except
Foreground IP which is discovered by or in conjunction with Biota), as soon as
reasonably practicable after becoming aware of that Foreground IP.
12.3 Biota hereby grants BioStar a non-exclusive license to use the
Foreground IP to the extent necessary to enable BioStar to exercise its rights
under clause 7. BioStar acknowledges that subject to the terms of this Agreement
third parties may also be granted by Biota rights to use the Foreground IP.
12.4 Subject to the terms of this Agreement, the parties acknowledge
and agree that Biota shall have the exclusive right to commercially exploit and
to protect any Foreground IP in whatever manner Biota may choose, including
without limitation, licensing of any third party or filing any patent
application during or after termination of this Agreement. Except as provided
for in this Agreement (including clause 16.9) Biota must not commercialize
Foreground IP in a manner which uses BioStar IP developed in the project without
obtaining from BioStar a royalty bearing license to do so (which will be
negotiated in good faith and will not be unreasonably withheld by BioStar).
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12.5 In the event that the parties do not proceed with an application
for FDA Clearance or commercialization of the Diagnostic in accordance with
clauses 4 and 5 or the termination of this Agreement, BioStar must promptly
return to Biota, upon demand, all material in its possession, power and control,
or in the possession, power or control of its Personnel in which Biota IP,
Foreground IP or Confidential Information of Biota is contained or embodied, or
from which it may be reproduced. BioStar shall promptly thereafter provide Biota
with a statutory declaration made by its representative or an authorized officer
declaring that neither they nor their Personnel have any such material in their
possession, power or control.
13. BIOSTAR IP
13.1 Biota shall, and shall ensure that its Personnel shall:
(a) keep all BioStar IP confidential;
(b) use BioStar IP solely for the Permitted Purposes;
(c) not disclose, without BioStar's written consent, BioStar IP
to any person other than Biota Personnel to whom disclosure is necessary for the
Permitted Purposes, and then only to the extent necessary; and
(d) not to reproduce any of the BioStar IP except as necessary
for the Permitted Purposes and with the prior permission of BioStar; unless
(e) the relevant BioStar IP is in the public domain or becomes
part of the public domain otherwise than as a result of a wrongful act of Biota,
(f) such intellectual property was not acquired directly or
indirectly from BioStar, or
(g) Biota independently developed the Intellectual Property
without reference to BioStar IP and can demonstrate such independent development
through competent written records.
13.2 Biota acknowledges and agrees that:
(a) it has no rights whatsoever in or in relation to BioStar IP
other than to use BioStar IP for the Permitted Purposes;
(b) it will not assert any ownership in respect of the BioStar IP
against BioStar or any third party from whom BioStar may have licensed the
BioStar IP; and
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(c) subject to clause 16.7 and the terms of this Agreement, third
parties may also be granted by BioStar rights to use the BioStar IP.
13.3 Biota agrees to make all reasonable endeavors to prevent BioStar
IP from being used for the benefit of any third party other than Biota, Biota
licensees, or third parties otherwise entitled to use the same.
13.4 Biota shall ensure that its Personnel to whom BioStar IP may be
disclosed execute a confidentiality undertaking in the form nominated by BioStar
and approved by Biota.
13.5 Biota acknowledges and agrees that all BioStar IP vests in and
is the exclusive property of BioStar and Biota has no rights whatsoever in or in
relation to the BioStar IP other than as expressly provided in this Agreement.
To the extent that any BioStar IP does not vest in BioStar as a result of the
foregoing Biota undertakes to procure the assignment of such Intellectual
Property to BioStar. Biota acknowledges and agrees that nothing in this
Agreement shall be interpreted as providing Biota with a license to use BioStar
IP, except as necessary for the Permitted Purposes or as provided in clause
16.9. BioStar must take such steps as are reasonably required to protect BioStar
IP used in the Diagnostic in the countries listed in Schedule 9, including
making application, prosecuting and maintaining patents in countries nominated
by Biota and shall keep Biota informed as to the status of such applications and
prosecutions. If BioStar fails to apply, prosecute or maintain patents in
relation to BioStar IP used in the Diagnostic in additional countries nominated
by Biota, Biota may apply for (in BioStar's name or subsequently assign the same
to BioStar) and proceed with patent applications, prosecutions or take such
steps as it deems necessary to maintain patents at its cost and expense,
provided that Biota has first advised BioStar of its intention to do so. BioStar
must render, and procure where necessary its employees or consultants to render,
all reasonable assistance to Biota in relation to filing prosecution, obtaining
or maintaining any such patents, including execution of relevant documentation.
13.6 BioStar represents and warrants to Biota on the date of this
Agreement and on each date BioStar IP is provided to Biota that to the best of
BioStar's knowledge, having made all reasonable enquiries, the BioStar IP and
any work undertaken by BioStar for the Permitted Purposes does not and will not
infringe the Intellectual Property of any third party. BioStar will promptly and
fully inform Biota in writing of:
(a) any infringement or threatened infringement of BioStar's
rights in and to BioStar IP and patents associated with that intellectual
property;
(b) any unauthorized use of BioStar IP; or
(c) any challenge or threat of challenge to the grant or validity
of any patent associated with BioStar IP or any part thereof or of
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BioStar's right to use BioStar IP or any part thereof as contemplated by this
Agreement, which may come to BioStar's attention.
13.7 In the event that the parties do not proceed with an application
for FDA Clearance or commercialization of a Diagnostic in accordance with
clauses 4 and 5 or the termination of this Agreement, Biota must promptly return
to BioStar, upon demand, all material in its possession, power and control, or
in the possession, power or control of its Personnel in which BioStar IP is
contained or embodied, or from which it may be reproduced. Biota shall promptly
thereafter provide BioStar with a statutory declaration made by its
representative or an authorized officer declaring that neither they nor their
Personnel have any such material in their possession, power or control.
14. PUBLICATION OF DEVELOPMENT PROJECT RESULTS AND OTHER INFORMATION
Without limiting clause 4 and clause 15 and except as permitted under this
Agreement, neither Biota nor BioStar shall publish or otherwise disclose
information describing or relating to the results of the Development Project or
the studies undertaken for the purposes of the Development Project or otherwise
arising in connection with the Permitted Purposes without the prior written
consent of the other party, which must not be unreasonably withheld or delayed.
15. CONFIDENTIALITY
15.1 The Disclosee shall, and shall ensure that its Personnel shall:
(a) keep all Confidential Information of the Disclosing Party
confidential;
(b) not use Confidential Information of the Disclosing Party
except as permitted by this Agreement;
(c) not disclose, without the Disclosing Party's prior written
consent, Confidential Information of the Disclosing Party to any person other
than the Disclosee's Personnel to whom disclosure is necessary for the Permitted
Purposes, and then only to the extent necessary, or to whom disclosure is
otherwise permitted by this Agreement; and
(d) not reproduce any of the Confidential Information of' the
Disclosing Party except as necessary for the Permitted Purposes or with the
prior permission of the Disclosing Party.
15.2 Nothing in this Agreement prohibits disclosure of information
which:
(a) at the time of first disclosure to the Disclosee is in the
public domain;
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(b) after disclosure to the Disclosee becomes part of the public
domain otherwise than as a result of the wrongful act of a party or one of that
party's disclosees;
(c) the Disclosee can show by written records was in its
possession at the time of first disclosure and was not acquired directly or
indirectly from the other party under a confidentiality obligation;
(d) is received from a third party provided that it was not
acquired directly or indirectly by that third party from a party to this
Agreement under a confidentiality obligation;
(e) is required to be disclosed by law, the Australian Stock
Exchange Limited or any government or governmental body, authority or agency
having authority over the Disclosee;
(f) is required to be disclosed in connection with legal
proceedings relating to this Agreement or enforcement of a Disclosee's rights
under this Agreement; or
(g) is independently developed without reference to the
Disclosee's Confidential Information, which independent development the
Disclosee can demonstrate through competent written records.
The onus shall be on the party alleging the same to prove that one of the above
exceptions applies.
15.3 Except as permitted by this Agreement, irrespective of whether
information disclosed to the Disclosee constitutes Confidential Information of
the Disclosing Party or not, the Disclosee agrees to use all reasonable
endeavors to prevent information disclosed by the Disclosing Party from being
used for the benefit of any third party other than the Disclosing Party, or in
the case of Biota, Biota's licensees or third parties otherwise entitled to use
the same. Similarly except as permitted by this Agreement, irrespective of
whether the results of the Development Project or other discoveries are to be
kept confidential, the Disclosee agrees to take all reasonable endeavors to
prevent the results of the Development Project or other discoveries arising in
connection with the Permitted Purposes from being used for the benefit of any
person other than the Disclosing Party.
15.4 Each party acknowledges that the rights in information disclosed
or otherwise communicated by the other party may be the rights of Biota, BioStar
or of a third party. In particular, BioStar acknowledges that Biota has
obligations of confidence to Glaxo Group in respect of certain Confidential
Information.
15.5 The Disclosee acknowledges that damages may not be a sufficient
remedy for the Disclosing Party for any breach of this Agreement and that the
Disclosing Party is entitled to seek specific performance or
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injunctive relief (as appropriate) as a remedy for any breach or threatened
breach by the Disclosee of this Agreement, in addition to any other remedies
available to the Disclosing Party at law or equity.
15.6 The confidentiality obligations in this Agreement are to continue
after, and survive, the termination of this Agreement, unless superseded by a
further written agreement relating to confidentiality.
16. TERM AND TERMINATION
16.1 This Agreement commences on the date of execution of this
Agreement and shall continue until the last of the Diagnostic Patents has
expired or, if there are no Diagnostic Patents, the date being 20 years after
the date of this Agreement, unless terminated earlier in accordance with this
clause 16 or extended for one or more additional one year terms by the written
agreement of the parties.
16.2 Either party may terminate this Agreement immediately if the
other party:
(a) becomes insolvent, goes or is put into liquidation or
dissolution (other than by way of reconstruction), or any action, steps or
proceedings are taken to effect any of the foregoing which proceedings are not
terminated within 60 days or otherwise permanently discontinues business; or
(b) makes any compromise, assignment or composition with its
creditors generally, has a receiver, manager, administrator, secured creditor or
other custodian appointed to it or taking possession of all or a substantial
part of its assets or business, or otherwise seeks to take advantage of
insolvency laws, which proceedings are not terminated within 60 days; or
(c) is in breach of any of its obligations under this Agreement
and has not rectified such breach within 45 days (or such longer period as the
parties agree in writing is reasonable in the circumstances) of receiving a
notice from the first party to do so.
16.3 Biota may immediately terminate this Agreement by giving notice
in writing to BioStar if any competitor of Biota or the Glaxo Group in the
fields of influenza therapeutics or influenza diagnostics acquires the power to
vote in respect of or to dispose of or control the disposal of more than 30% of
the outstanding voting shares of BioStar.
16.4 Biota may, at any time prior to submission of an Application for
FDA Clearance of the Diagnostic, terminate this Agreement by giving not less
than 60 days written notice to BioStar.
16.5 In the event that Biota terminates this Agreement under clause
16.4:
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(a) Biota agrees to reimburse BioStar for all expenses directly
and reasonably incurred by BioStar as a result of such termination upon
production of satisfactory, documented evidence of such expenditure; and
(b) if BioStar is meeting the Diagnostic specifications and goals
set out in Schedule 3 at the time of termination, Biota agrees to grant BioStar
a license to use Biota IP and Foreground IP to the extent necessary to enable
BioStar to commercialize a Compound-based assay in the US on the following
terms:
(i) BioStar shall repay Biota [*] of all payments made to
BioStar by Biota under the Diagnostic Project Research Agreement and this
Agreement (including any and all development, feasibility or incentive payments)
plus interest at LIBOR over the period from the date of the relevant payment to
the date of termination of this Agreement; and
(ii) BioStar shall pay Biota [*] royalty on the Operating
Margin of BioStar relating to the sale of all products incorporating the
Compound-based assay by BioStar;
such payments to be made immediately prior to the first sale or other return
from such commercialization.
16.6 Termination of this Agreement for any reason does not affect:
(a) any rights of a party against the other party which:
(i) arose prior to the time at which such termination
occurred; or
(ii) otherwise relate to or may arise at any future time from
any breach or non-observance of obligations under this Agreement occurring prior
to termination;
(b) the rights and obligations of the parties under clauses 10,
11, 12, 13, 14, 15, 16 and 18.
16.7 BioStar agrees that it shall not, and shall procure that none of
its Related Body Corporates, engage in research studies, research, assistance or
development in respect of any device or procedure for use in or in connection
with the diagnosing influenza virus other than with Biota:
(a) during the term of this Agreement; and
(b) for a period of 2 years from the termination of this
Agreement (for any reason other than a breach by Biota or termination by Biota
for reasons that do not relate to BioStar's performance or condition or the
progress of the Development Project),
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unless BioStar has first offered Biota the opportunity to engage in such
research studies, assistance or development on terms substantially similar to
those set out in this Agreement in writing and Biota has declined that offer
in writing, or more than 45 days have elapsed from the date of receipt of such
offer by Biota. BioStar must provide Biota with all necessary information to
enable Biota to assess any such offer.
16.8 If the parties do not elect to extend the term of this Agreement
under clause 16.1, Biota agrees to grant BioStar the non-exclusive right to
manufacture the Diagnostic for supply to Biota upon terms substantially similar
to those granted to BioStar under clause 5 after termination of this Agreement.
16.9 If upon termination of this Agreement, BioStar does not elect to
manufacture the Diagnostic for Biota under clause 16.8, or if this Agreement is
terminated by Biota under clauses 16.2 or 16.3, BioStar hereby grants to Biota
or its nominee an exclusive world-wide license to use the BioStar IP for the
purposes of developing, manufacturing, selling and distributing the Diagnostic.
Biota agrees to pay BioStar a reasonable royalty for the grant of such license,
the amount of which will be negotiated in good faith.
17. INDEMNITY
17.1 Except as expressly provided by Prescribed Terms (if any) or as
otherwise expressly provided in this Agreement, a party will not be liable to
the other party (whether arising in contract, in tort, under statute or in any
other way and whether due to negligence, willful or deliberate breach or any
other cause) under this Agreement or for any act, omission or event arising out
of this Agreement for or in respect of any direct or indirect liability, loss,
damage, cost, charge or expense.
17.2 A party ("Indemnifying Party") must indemnify the other party
("Innocent Party") and hold the Innocent Party harmless from all claims,
actions, demands, liability, costs, charges and expenses:
(a) arising out of or relating directly to the actions of the
Indemnifying Party under or performed in accordance with this Agreement;
(b) arising directly as a result of the death or personal injury
of the Personnel of the Indemnifying Party, except to the extent that such death
or personal injury is caused by the negligence or willful conduct of the
Innocent Party; or
(c) arising out of the claim by a third party against the
Innocent Party alleging that the Innocent Party's use or exploitation of any
Intellectual Property or Confidential Information of the Indemnifying Party,
whether on its own or as part of the Diagnostic or Foreground IP, infringes any
Intellectual Property of that third party.
28.
32
17.3 If an act or omission of a party ("Indemnifying Party") or its
officers, employees, agents or contractors is in breach of this Agreement or is
negligent or willful and:
(a) the other party ("Innocent Party") suffers direct loss or
damage; or
(b) such act or omission directly results in a claim against the
Innocent Party by a third party, the Indemnifying Party shall indemnify and hold
harmless the Innocent Party from such direct loss or damage, or any costs or
damages or settlement payments arising as a direct result of such claim,
provided the Innocent Party shall not agree to any settlement without the prior
consent of the Indemnifying Party (such consent not to be unreasonably
withheld).
17.4 Each indemnity in this Agreement is a continuing obligation,
separate and independent from the other obligation of the parties and survives
termination or expiry of this Agreement.
17.5 It is not necessary for a party to incur expense or make payment
before enforcing a right of indemnity conferred by this Agreement.
17.6 Each party warrants to the other that it has in place and will
keep current during the term of this Agreement and for any additional period
required to cover claims arising out of the Development Project or this
Agreement and will not vitiate or render void or voidable adequate insurance
coverage which will insure it in respect of any liability which one party may
have to the other or to third parties as a result of or arising out of the
Development Project or this Agreement.
18. FURTHER COLLABORATION
Nothing in this Agreement shall prevent Biota from undertaking a
collaborative project or entering an agreement with a third party for the
purpose of or in relation to the use of Biota IP or Foreground IP in conjunction
with the Intellectual Property of such third party to develop one or more
diagnostics, provided that in the event Biota enters into a collaboration with a
third party and develops and markets an influenza diagnostic in competition to
the Diagnostic, BioStar's obligations under clause 7.1 to sell at least the
Minimum Sales Volume for each Sales Year shall cease.
19. TAXATION
Biota and BioStar agree that a payment made under this Agreement will be
net of any Taxes. Biota and BioStar agree that the payor of any such Taxes must
provided to the payee all information and documents
29.
33
that will enable the payee to claim any credit, refund or rebate to which the
payee is entitled in respect of Taxes levied on a payment.
20. RELATIONSHIP OF PARTIES
Neither party is, and nothing in this Agreement shall be taken as making
either party, an agent, employee or partner of the other.
21. NOTICES
21.1 Except as otherwise expressly provided, a notice, approval,
consent or other communication in connection with this Agreement:
(a) must be in writing and legible; and
(b) must be left at the address of the addressee, or sent by
prepaid ordinary post (airmail if posted to or from a place outside Australia)
to the address of the addressee or sent by facsimile to the facsimile number of
the addressee and marked for the attention of the representative which is
specified in this clause or if the addressee notifies another address or
facsimile number or representative then to that address or facsimile number or
representative.
The address, facsimile number, and representative of each party is:
Biota
Address: Biota Scientific Management Pry Ltd
Level 4
616 St Kilda Road
Melbourne Vic 3004
Facsimile: 61 3 9529 2261
Attention: Company Secretary
BioStar
Address: 6655 Lookout Road
Boulder, Colorado, 80301
Facsimile: (303) 530 6641
Attention: President
21.2 A notice, approval, consent or other communication takes effect
from the time it is received unless a later lime is specified in it.
21.3 A letter or facsimile is taken to be received:
(a) in the case of a posted letter, on the third (seventh, if
posted to or from a place outside Australia) day after posting;
30.
34
(b) in the case of facsimile, on production of a transmission
report by the machine from which the facsimile was sent which indicates that the
facsimile was sent in its entirety to the facsimile number of the recipient
provided that where transmission is completed after 5pm on a business day or is
sent on a day that is not a business day, the message will not be deemed to have
been received until the next business day; and
(c) in the case of a letter sent by an internationally recognized
courier, on the third day after its sent.
22. ASSIGNMENT
A party cannot sell, assign, pledge or otherwise transfer or dispose of its
rights or interests under this Agreement, or novate any of its rights under this
Agreement without the prior written consent of the other party, unless such
sale, assignment, pledge or other transfer or disposal is part of the sale or
disposal of the entire undertaking of that party and in the case of BioStar such
sale or disposal is not to a competitor of Biota or the Glaxo Group in the
fields of influenza therapeutics or diagnostics.
23. WAIVER AND VARIATION
A provision of or a right created under this Agreement may not be:
(a) waived except in writing signed by the party granting the
waiver; or
(b) varied except in writing signed by both parties.
24. REMEDIES CUMULATIVE
The rights, powers and remedies provided in this Agreement are cumulative
with and not exclusive of the rights, powers or remedies provided by law
independently of this Agreement.
25. FURTHER ASSURANCES
Each party agrees, at its own expense, on the request of the other party,
to:
(a) do everything reasonably necessary to give effect to this
Agreement and the transactions contemplated by it, including without limitation
the execution of documents; and
(b) use its best endeavors to cause relevant third parties to do
likewise.
31.
35
26. SUPERVENING LEGISLATION
Any present or future legislation which operates to vary an obligation or
right, power or remedy of a person in connection with this Agreement is excluded
except to the extent that its exclusion is prohibited or rendered ineffective by
law.
27. SEVERABILITY
If the whole or any part of a provision of this Agreement is void,
unenforceable or illegal in a jurisdiction it is severed for that jurisdiction.
The remainder of this Agreement has full force and effect and the validity or
enforceability of that provision in any other jurisdiction is not affected. This
clause has no effect if the severance alters the basic nature of this Agreement
or is contrary to public policy.
28. ENTIRE AGREEMENT
This Agreement and the Diagnostic Project Research Agreement constitute the
entire agreement of the parties about its subject matter and all other
agreements, undertakings and negotiations on the subject matter cease to have
any effect.
29. GOVERNING LAW
29.1 This Agreement and the transactions contemplated by this
Agreement are governed by the law in force in the State of Victoria, Australia.
29.2 Each party irrevocably and unconditionally submits to the
non-exclusive jurisdiction of the courts of the State of Victoria and courts of
appeal from them for determining any dispute concerning this Agreement or the
transactions contemplated by this Agreement. Each party waives any right it has
to object to an action being brought in those courts, to claim that the action
has been brought in an inconvenient forum, or to claim that those courts do not
have jurisdiction.
30. ARBITRATION OF PAYMENTS
30.1 Any dispute, controversy or claim between the parties as to
financial or payment issues under this Agreement (other than entitling a party
to proceed for equitable relief) which cannot be promptly resolved between the
parties is to be resolved by arbitration, administered by the Australian
Commercial Disputes Centre Limited, conducted at Melbourne and held in
accordance with and subject to the Commercial Arbitration Act 1984 (Vic).
32.
36
30.2 Arbitration shall be effected by a single arbitrator appointed in
accordance with clause 30.3. Such arbitration shall be held in Victoria or such
other place as the parties may agree.
The arbitration shall be conducted in accordance with the Institute of
Arbitration Australian Rules for the Conduct of Commercial Arbitrations.
The arbitrator shall not be an employee of either party nor a person who
has been connected with work under this Agreement. The Arbitration shall be
private and confidential.
The arbitrator may award whatever interest the arbitrator considers
reasonable.
30.3 For the purposes of the arbitration proceedings under clause
20.1, the parties agree to appoint an arbitrator from any international firm of
chartered accountants. If the parties do not agree on the arbitrator to be
appointed, the arbitrator is to be a person nominated by the Secretary General
for the time being of the Australian Commercial Disputes Centre Limited in
Victoria.
31. PUBLICITY
The parties shall maintain confidentiality concerning the terms of this
Agreement and details of its subject matter (including details of the
Development Project, its progress and results, the manufacture, sale and
distribution of the Diagnostic and any submission for FDA approval made under
this Agreement) and no public announcement or communication relating to the
negotiations of the parties or the existence, subject matter or terms of this
Agreement, may be made or authorized by a party without the prior written
approval of the other party except that a party may make a disclosure in
relation to this Agreement:
(a) to its professional advisers, bankers, financial advisers and
financiers upon those persons undertaking to keep confidential any information
so disclosed; or
(b) to comply with any applicable law or requirement of any
regulatory body including the Australian Stock Exchange Limited. In such a case
the party proposing to make the disclosure shall use all reasonable endeavors to
ensure the other party consents to the content and form of the disclosure.
EXECUTED as an agreement
33.
37
SCHEDULE 1
DEVELOPMENT WORK PLAN
1. Activities for the Project are shown in the attached table. Detailed
activities and review points are shown in attached Overview of Project
Flow. Phases II and III correspond with internal development process Steps
4, 5 and 6, Phase IV represents Steps 7 and 8, and Phase V represents Steps
9-11.
2. Monthly reports will be provided on progress.
3. An early prototype for international research will be tested during Phase
III clinical trials in Australia commencing 1 May 1997.
4. Delivered "research use only" product will be available for Phase III
clinical trials in the US and international sale by [ * ]. The
purchase price of product by Glaxo Wellcome will be jointly negotiated by
Biota and BioStar. It will be developed in accordance with BioStar's
product development guidelines and in compliance with the FDA's Device
Design Requirements.
5. The FDA position on approval criteria indicates that an influenza
diagnostic will be accepted for review under a 510(k) format. The
diagnostic clearance will be based on the clinical study protocol, claims
and intended use.
34.
38
- -------------------------------------------------------------------------------------------------------------------
PHASE II PHASE III PHASE IV PHASE V
- -------------------------------------------------------------------------------------------------------------------
1 July - [ [
1 April - 30 June 1997 14 September 1997 * ] * ]
- -------------------------------------------------------------------------------------------------------------------
1. Surface optimization 1. Tolerance testing 1 International clinicals 1. Technical support
2. Conjugate optimization 2. Formulation tolerance 2. Product of Phase III 2. Data analysis
3. Extraction reagents 3. Process tolerance trials 3. 510k submission
4. Sample types 4. Qualification runs 1 & 2 3. Product for 4. FDA Q&A responses
5. Controls 5. Characterize international sales 5. Reimbursement
6. Stability studies performance of 4. Qualification Run 3/
7. SOPs, QCPs, MPs analytical sensitivity, scale up
8. FDA Protocols analytical specificity/ 5. Unit cost confirmed
9. FDA Education cross reactivity, 6. Kit stability studies
10. Customer feedback interference 7. US clinicals
11. Prototype for 6. Shipping studies 8. Customer feedback
Australian Phase III 7. In-house clinicals 9. Reimbursement
trials 8. Trials site selection
9. Customer feedback
- -------------------------------------------------------------------------------------------------------------------
DEVELOPMENT WORK PLAN - COMPOUND BASED
INFLUENZA DIAGNOSTIC RESEARCH PROGRAM
PROGRAM GOAL
To incorporate Biota Compounds with BioStar's [ * ] Optical ImmunoAssay
surfaces into a delivery format that can achieve analytical sensitivity greater
than the Becton Dickinson assay in an assay time of 15 minutes or less.
SPECIFIC GOALS
1. Analytical sensitivity greater than [ *
] for at least two influenza A and B strains.
2. A minimum number of steps and reagents [ * ]
3. As rapid as possible [ * ]
4. [
*
]
OVERVIEW
Funding for research on a compound-based assay has been committed for up to one
year. It is BioStar's aim that a working assay will be available sooner which
can be evaluated on clinical samples to establish the feasibility of the assay
format.
Initial efforts will focus on identification of candidate compounds and formats
so that the path chosen has the highest likelihood of success. Preparation of
new compounds will be done in conjunction with [ * ] of Biota
Chemistry Laboratory. Reagent selection and formatting will be initiated
including evaluation of alternate attachment and anti-reflective layers and
determination of which optical stack will provide optimal binding and
sensitivity of the compound or compound carrier complex. After selecting the
appropriate compound/carrier combination and surface chemistry, formulation of
ancillary components such as diluent, extraction reagents and wash will be
included.
Clinical specimens (i.e. from naturally infected patients) as well as spiked
samples from normal healthy volunteers will be included during the later phases
of feasibility to insure that we are capable of handling clinical specimens.
If the project demonstrates assay feasibility, a further development agreement
with Biota may be negotiated.
ACTIVITIES FOR APRIL 1997
1. Review progress to date on current status of compound-based assay formats.
2. Coordinate with [ *
] (6 months to completion)
35.
39
3. Continue the [ * ]
4. Initiate the production of [ * ] for subsequent
testing.
5. Confirm the [* ] results.
6. Initiate conjugation of [ * ] surfaces.
7. Coordinate with [ * ] on the construction of [
* ]
ACTIVITIES [ * ]
APRIL - JUNE 1997
This quarter will see the initiation of work on the [ * ] OIA surfaces
and the initial attempts at the transfer of the compound based assays to the new
surfaces. A library of optical test surfaces will be created with the assistance
of [ * ] at BioStar. We will also identify a number of potential assay
formats and begin the evaluation of these formats.
JULY - SEPTEMBER 1997
The second quarter will focus on development of specific assay conditions
required for the [ * ] compound based assay. During this quarter we
should be able to select the specific compound/carrier combination which will
provide for a working assay. It is anticipated that we may need additional
compound/carrier combinations synthesized based on the best choice out of the
initial library, which will allow us to optimize the performance of the selected
components. We will also complete the evaluation of the optical stack options
which were created during the preceding quarter. Ancillary components, which are
required for the formatting of the compound based assay (dilutents, extraction
reagents, wash, substrate options) will be identified and formulated. It is
recognized that a prototype device (plastic parts to hold the test surface and
absorbent backing) will need to be identified. It is possible that we will be
able to tap into components being developed for other programs.
[ * ] will be tested when available from [
* ]
OCTOBER-DECEMBER 1997
Using the assay components developed to date, the assay will be evaluated on
spiked samples from normal healthy volunteers and frozen samples from specimen
banks. It is likely that we will need to re-optimize the assay based on these
results and repeat the testing. Preliminary evaluation of component stability
will be initiated. Evaluation of extraction buffers will also be undertaken at
this time.
[ * ]
The [ * ] focuses on evaluation of the compound-based assay using
clinical specimens from a broad age range of patients. It is anticipated that
fresh specimens may pose different extraction or handling characteristics than
may have been seen using banked, frozen specimens. Therefore, it is likely that
final optimization of portions of the assay may be required. Final performance
characteristics will be established on the [ * ] compound-based assay.
36.
40
REPORTING
At the beginning of each month, a written report, detailing the results from the
work of the preceding month as well as the anticipated direction of the work of
the next month will be forwarded from BioStar to Biota. This may be accompanied
by either teleconference or video conferences between Biota staff and BioStar
staff to discuss the results and then arrive at consensus at the direction for
the anticipated research.
37.
41
SCHEDULE 2
DEVELOPMENT BUDGET
- ------------------------------------------------------------------------------------------------------------------
PHASE II PHASE III PHASE IV PHASE V
(%) (%) (%) (%)
- ------------------------------------------------------------------------------------------------------------------
1 April - 1 July - [ [
30 June 1997 14 Sept 1997 * ] * ]
- ------------------------------------------------------------------------------------------------------------------
FTES 100% = 1 FTE
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- --------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[ * ]
- ------------------------------------------------------------------------------------------------------------------
[
*
]
- ------------------------------------------------------------------------------------------------------------------
Totals: Phases II-V [ * ] [ * ] [ * ] [ * ]
- ------------------------------------------------------------------------------------------------------------------
TOTAL [ * ]
- ------------------------------------------------------------------------------------------------------------------
Continuation of compound based work from [ * ] [ * ]
- ------------------------------------------------------------------------------------------------------------------
GRAND TOTAL [ * ]
- ------------------------------------------------------------------------------------------------------------------
Biota will pay costs (US dollars) for each phase of development according to the
following schedule:
- ----------------------------------------------------------------------------------------------------------------------
PAYMENT: TOTAL USD
PHASE DATE DEVELOPMENT 1 RESEARCH 2 PAYMENT
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
38.
42
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
[ * ]
- ----------------------------------------------------------------------------------------------------------------------
TOTAL [ * ] [ * ] [ * ]
- ----------------------------------------------------------------------------------------------------------------------
1. For Phase II-V
2. For continuing compound-based research
1. If the choice is made by 1 April to proceed with a non-antibody based assay
system, then antibody related expenses would not be charged to the program.
2. Compound based research will continue from [ * ] at
the level of [ * ]. The objective is to continue the optimization of a
compound based approach for a new version of the influenza diagnostic.
3. Clinical study costs may vary once the precise protocol is agreed upon with
the FDA. Actual clinical study costs would be used. Any reconciliation with
estimates can occur during Phase V.
4. Payments will be made 60 days in advance on the indicated date by wire
transfer.
5. Before payments are made for Phase II, invoices will be provided to Biota
incorporating any antibody costs required for the development. Payments
will then be adjusted accordingly.
6. Before payments are made for Phase IV, invoices will be provided to Biota
based on the cost of US clinicals and the protocol agreed with the FDA.
Payments will then be adjusted accordingly.
39.
43
SCHEDULE 3
DIAGNOSTIC SPECIFICATIONS AND GOALS
A. CRITICAL FEATURES
1. Clinical Sensitivity: [*] of resolved viral tissue culture for
Influenza A and B. Resolution may be with a variety of methods.
2. Clinical Specificity: [*] of resolved viral tissue culture for
Influenza A and B. Resolution may be with a variety of methods.
3. Costs of goods sold at: Test Volume
1 million devices/year $TBD
3 million devices/year $TBD
5 million devices/year $TBD
4. Ease of Use: CLIA moderately complex device equivalent. Time to test
completion: < or equal to 15 minutes. No result interpretation
before test completion is intended.
B. MARKET
1. > or equal to 20 tests per month practices.
C. SPECIMEN / SWAB TYPES
1. Stock, sterile Dacron or rayon tipped swabs (hollow or solid, no
wood). (BD or equivalent.) PBS for washes/gargles.
2. Swabs/washes are supplied by user. They are not included in the assay
kit.
D. WORKFLOW / EASE OF USE
1. Tests can be run in a lab area with: (a) no unique drain or
ventilation, and (b) 1000-2000 Lux and 100-200 foot candles
illuminance.
2. Multiple tests (< or equal to 10) can be run simultaneously,
limited only by the operator's ability to sequence reagents, time
steps, and read a result between the test completion time and time
limit for result stability.
3. Assay performed at room temperature, i.e. 15(degree) - 30(degree)C.
4. No sample manipulation or pretreatment occurs before use with the
test.
5. Endpoint of the test is a crisp-edged, distinct color change that is
limited to a presence/absence interpretation.
E. SYSTEM COMPONENTS
1. Extraction tube
40.
44
2. OIA device
3. Extraction reagent, conjugate, wash, and substrate (if required) are
contained within the kit.
4. Controls (positive and negative).
F. DEVICE
1. Current, 1.0 version OIA test device (silicon wafer based).
2. Each device is a single test.
3. Area 1" x 5/8" (2.5 x 1.6 cm) for writing or affixing label of patient
name/ID is provided.
4. Visually read surface.
5. Materials compatibility with:
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
6. Surface optically coated silicon wafer, static (non-porous).
7. Device material: commodity resin, white color, matte finish
8. Absorbent papers: equivalent to those in use with [ * ]
G. STABILITY
1. Shipping
[ *
]
[ * ]
[ * ]
d. FYI. Consider an indicator, e.g. temperature dot, for shipment
acceptability at delivery.
2. Shelf Life:
a. at market entry: [ * ] at room temperature
b. after six months on market: [ * ] months
at room temperature
c. humidity: TBD
3. Result: should remain stable for not less than [ * ].
H. STORAGE
1. [ * ] at time of manufacture for device [ * ] at time
of manufacture for reagents
41.
45
I. ASSAY PROCESSING STEPS
1. Direct Detection
a. Swab/sample and extraction reagent are combined
b. Conjugate added to sample/extraction tube
c. Sample added to OIA surfaces
d. Wait/wash
e. Substrate added to OIA surface
f. Wait/wash
g. Read
J. WITHIN DEVICE CONTROLS
1. Procedural control utilizing purified antigen or anti-species capture
antibody to produce color only if free conjugate has been captured and
is incorporated on the device surface.
K. EXTERNAL CONTROLS
1. Positive and negative controls are provided. These controls may be
solutions or lyophilised.
L. ANALYTICAL PERFORMANCE
1. Analytical Sensitivity: [ *
]
2. Analytical Specificity: [ * ]
3. No x-reactivity with normal throat flora.
4. Preservative Efficacy Testing (PET) - ProClin - USP + rechallenge.
M. LABELING / PACKAGE INSERT
1. Require labels/package inserts in six languages: English, Spanish,
French, German, Japanese and Italian. Translations to be provided by
Biota.
2. Symbology (storage, sampling, etc.) should be used whenever possible
(TBD what symbols are commonly used).
3. Abbreviate ex-US package inserts to required content to meet 97 EU
standards.
4. No unit labeling.
5. Controls will meet FDA guidelines for review of Calibration and
Quality Control Labeling for In Vitro Diagnostic Devices (1 Feb.
1996).
N. PACKAGING
1. Utilize recyclable materials whenever possible.
2. Thirty test kits and 100 test kits sizes.
42.
46
3. Inner and outer packaging TBD
a. no unit packaging
b. require packaging in six languages: English, Spanish, French,
German Japanese and Italian.
4. Symbology (storage, sampling, etc.) should be used whenever possible
(TBD what symbols are commonly used).
5. Put labeling, i.e. name and lot information on the front of the
package for easy viewing.
O. SHIPPING
1. USA
a. ship via ground transportation to distributors (5 days) at room
temperature.
b. two to three days air distribution to customers - TBD
2. International
a. air shipments - 5 days maximum
b. kit tolerance to 5 days, unprotected
3. Drop test: no damage with 3 x 36" (1m.) falls.
4. Other shipping tests as per ASTM and UPS standards - TBD
P. REAGENTS
1. Conjugate a. liquid
b. TBD chemistry
2. Extraction Reagent a. liquid
b. TBD chemistry
3. Substrate a. liquid
b. Custom BioStar formulation
4. Wash a. liquid
b. TBD chemistry
43.
47
SCHEDULE 4
COMPOUNDS
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
44.
48
SCHEDULE 5
OPTICAL IMMUNOASSAY
Optical Immunoassay (OIA) refers to the interaction of light with thin
biological films on an optical support. Three major areas are covered. First the
design and construction of the optical support, second the methods and
instruments used for detecting the changes in the incident light as a result of
interaction with the optical support, and third, the assays and methods for
amplification of OIA techniques.
The optical support may be defined as any solid support selected for specific
optical characteristics. The required optical characteristics are tied to the
detection method to be used in the final assay format. The optical support may
be further described by inclusion of one or more optical thin film or
anti-reflective layer. The optical support also includes thin films of materials
designed to promote the adhesion or binding of the biological thin films to the
support.
Second, OIA also includes the methods and instruments useful of the measurement,
quantization, or interpretation of the signal generated as a result of light's
interaction with the optical support. These methods include visual interference
effects, ellipsometry, comparison ellipsometry, changes in the state or degree
of polarization for a polarized light source, and related thin film measurement
technologies.
Third, OIA covers the amplification of the signal generated on a thin film
optical support. The critical feature of such an amplification process is that
the method and materials amplify the mass or thickness change on the surface of
the optical support while maintaining the original thin film properties and
characteristics of the support.
45.
49
SCHEDULE 6
MINIMUM SALES VOLUMES
1. PERIOD AFTER FORMAL LAUNCH OF GGI67 COMPOUND AS THERAPEUTIC AGENT IN
TREATMENT OF INFLUENZA IN THE US
BioStar shall sell a minimum number of units of Diagnostic during each year
commencing on the first day of the month immediately following the month in
which the formal launch of GG167 occurs as follows:
- ---------------------------------------------------------------------------------------------
PERIOD (SALES YEARS) AFTER FORMAL MINIMUM NUMBER OF UNITS OF DIAGNOSTIC
LAUNCH OF GG167 TO BE SOLD BY BIOSTAR IN THE UNITED STATES OF
AMERICA DURING SALES YEAR INDICATED
- ---------------------------------------------------------------------------------------------
Year 1 [ * ]
- ---------------------------------------------------------------------------------------------
Year 2 [ * ]
- ---------------------------------------------------------------------------------------------
Year 3 [ * ]
- ---------------------------------------------------------------------------------------------
Year 4 [ * ]
- ---------------------------------------------------------------------------------------------
Year 5 [ * ]
- ---------------------------------------------------------------------------------------------
Each year thereafter [ * ]
- ---------------------------------------------------------------------------------------------
2. PERIOD PRIOR TO FORMAL LAUNCH OF GG167 COMPOUND AS THERAPEUTIC AGENT IN
TREATMENT OF INFLUENZA IN THE US
In the event that FDA Clearance of the Diagnostic is granted and the use of
the Diagnostic is launched prior to the formal launch of GG167, BioStar
shall sell a minimum number of units of Diagnostic during each year
commencing on the first day of the month immediately following the month in
which the formal launch of the Diagnostic occurs and prior to the formal
launch of GG167 as follows:
- -----------------------------------------------------------------------------------------------
PERIOD (SALES YEARS) AFTER FORMAL MINIMUM NUMBER OF UNITS OF DIAGNOSTIC
LAUNCH OF THE DIAGNOSTIC TO BE SOLD BY BIOSTAR IN THE UNITED STATES
DURING SALES YEAR INDICATED
- -----------------------------------------------------------------------------------------------
Year 1 [ * ]
- -----------------------------------------------------------------------------------------------
Each year thereafter [ * ]
- -----------------------------------------------------------------------------------------------
For the purposes of this schedule 6, the number of units sold is the number
of units sold to third parties or classes of third parties who have been
approved in writing by Biota.
46.
50
SCHEDULE 7
DISTRIBUTION ALLOWANCES
1. BIOSTAR DISTRIBUTION ALLOWANCE
1.1 PERIOD AFTER FORMAL LAUNCH OF GG167 COMPOUND AS THERAPEUTIC AGENT IN
TREATMENT OF INFLUENZA IN THE US.
The BioStar Distribution Allowance shall be equal to a percentage of
the Gross Sales Revenue of BioStar relating to its sale of Diagnostic
in the US during each year after the formal launch of GG167 as
follows:
- ---------------------------------------------------------------------------------------
PERIOD (SALES YEARS) AFTER FORMAL DISTRIBUTION ALLOWANCE EQUAL TO
LAUNCH OF GG167 FOLLOWING PERCENTAGES OF GROSS SALES
REVENUE OF BIOSTAR RELATING TO SALE OF
DIAGNOSTIC IN THE US DURING SALES YEAR
INDICATED
- ---------------------------------------------------------------------------------------
Year 1 [*]
- ---------------------------------------------------------------------------------------
Year 2 [*]
- ---------------------------------------------------------------------------------------
Year 3 [*]
- ---------------------------------------------------------------------------------------
Year 4 [*]
- ---------------------------------------------------------------------------------------
Year 5 [*]
- ---------------------------------------------------------------------------------------
Each year thereafter [*]
- ---------------------------------------------------------------------------------------
1.2 PERIOD PRIOR TO FORMAL LAUNCH OF GGL67 COMPOUND AS THERAPEUTIC AGENT
IN TREATMENT OF INFLUENZA IN THE US.
In the event that FDA Clearance of the Diagnostic is granted and the
Diagnostic is launched prior to the formal launch of GG167, shall be
as follows during each year after the formal launch of the Diagnostic
and prior to the formal launch of GG167.
- ---------------------------------------------------------------------------------------
PERIOD (SALES YEARS) AFTER FORMAL LAUNCH DISTRIBUTION ALLOWANCE EQUAL TO FOLLOWING
OF THE DIAGNOSTIC PERCENTAGES OF GROSS SALES REVENUE OF
BIOSTAR RELATING TO SALE OF DIAGNOSTIC IN
THE US DURING SALES YEAR INDICATED
- ---------------------------------------------------------------------------------------
Year 1 [*]
- ---------------------------------------------------------------------------------------
Each year thereafter [*]
- ---------------------------------------------------------------------------------------
The Distribution Allowance set out in this paragraph 1.2 will be
decreased from [*] to [*] with effect from the formal launch of GG167.
47.
51
2. BIOTA DISTRIBUTION ALLOWANCE
Biota Distribution Allowance shall be equal to a percentage of the Gross
Sales Revenue of Biota relating to the sale of Diagnostic in the US as
follows:
- ---------------------------------------------------------------------------------------
PERIOD FOLLOWING THE DISTRIBUTION ALLOWANCE EQUAL TO FOLLOWING
COMMENCEMENT OF SALES OF DIAGNOSTIC BY PERCENTAGES OF GROSS SALES REVENUE OF BIOTA
BIOTA IN THE US RELATING TO SALE OF DIAGNOSTIC IN THE US
DURING SALES YEAR INDICATED
- ---------------------------------------------------------------------------------------
Year 1 [*]
- ---------------------------------------------------------------------------------------
Year 2 [*]
- ---------------------------------------------------------------------------------------
Year 3 [*]
- ---------------------------------------------------------------------------------------
Year 4 [*]
- ---------------------------------------------------------------------------------------
Year 5 [*]
- ---------------------------------------------------------------------------------------
Each year thereafter [*]
- ---------------------------------------------------------------------------------------
48.
52
SCHEDULE 8
PRO-FORMA COMMERCIALIZATION PLAN
The commercialization plan will include:
1. PERFORMANCE DATA
(a) Preclinical data for sensitivity and specificity
(b) 510(k) trial site data (if available)
(c) Competitive performance comparison
2. FORECAST / BUILD PLANS
(a) Domestic forecast (customer kits, sample kits)
(b) International forecast (customer kits, sample kits)
(c) Worldwide production plan/inventory projections
3. PRODUCT LABELING
Samples of labels, package insert draft, cartons, procedure card
4. PHOTOGRAPHS
Photographs appropriate for early publicity
5. TRAINING MATERIALS
To include:
US market overview
Medical positioning/justification versus other methods
Reimbursement position
Financial justification for use
Troubleshooting guide
Operator instrumentation
Competitive comparisons
CLIA materials
6. COLLATERAL MATERIAL
Drafts of sales sheets
49.
53
SCHEDULE 9
BIOSTAR PATENT COUNTRIES
Austria
Belgium
Switzerland
Germany
Benelux (Belgium, Netherlands, Luxembourg)
Spain
France
United Kingdom
Italy
Sweden
Japan
Canada
Mexico
United States of America
Australia
EXECUTION PAGE
SIGNED by Richard Wadley )
as authorized representative for BIOTA )
SCIENTIFIC MANAGEMENT PTY LTD in the )
presence of: )
)
)
)
/s/ Phillip Andrew Reece )
- -------------------------------------- )
Signature of witness )
)
)
Phillip Andrew Reece ) /s/ Richard Wadley
- -------------------------------------- ) --------------------------------
Name of witness (block letters) ) By executing this Agreement the
) signatory warrants that the
) signatory is duly authorized to
) execute this Agreement on behalf
) of BIOTA SCIENTIFIC MANAGEMENT
) PTY LTD
Biota Scientific Mgt Pty Ltd. )
Level 4 - 616 St Kilda Rd. )
- -------------------------------------- )
Address of witness Melbourne. )
)
)
Director, Research and Development )
- -------------------------------------- )
Occupation of witness )
SIGNED by )
as authorized representative for BIOSTAR, )
INC. in the presence of: )
)
)
/s/ Noel T. Doheny )
- -------------------------------------- )
Signature of witness )
)
)
Noel T. Doheny ) /s/ Teresa W. Ayers
- -------------------------------------- ) --------------------------------
Name of witness (block letters) ) By executing this Agreement the
) signatory warrants that the
) signatory is duly authorized to
) execute this Agreement on behalf
) of BIOSTAR, INC.
6650 Lookout Road )
Boulder CO 80503 )
- -------------------------------------- )
Address of witness )
)
)
Exec VP Commercial Development )
- -------------------------------------- )
Occupation of witness )