EXHIBIT 10.7
AGREEMENT DATED JUNE 6, 2001 BETWEEN CLEARCOLL PTY LTD
AND PRAXIS PHARMACEUTICALS INTERNATIONAL PTY LTD.
AGREEMENT dated June 6th 2001
BETWEEN
CLEARCOLL PTY LTD (ACN: 076 764 013) of 000 Xxxxxxx Xx, Xxxxxxxxx XXX 0000
('CLEARCOLL')
AND
PRAXIS PHARMACEUTICALS INTERNATIONAL PTY LTD (ACN 092 654 870) of Xxxxxxx Xxxxx,
Xxxxx Xxxx, Xxxxxxxx, XXX ('PRAXIS')
BACKGROUND
A. Clearcoll has knowledge of and/or IPR in respect of the preparation and
use of compositions for skin care, dermal filling and wound healing
(the 'FIELD').
B. Praxis has knowledge of and IPR in respect of mono and polysaccharides
and analogues thereof which attract fibroblasts and/or similar cells
(the 'PRAXIS POLYSACCHARIDES').
C. Clearcoll desires to investigate the use of the Praxis Polysaccharides
in the Field and Praxis is agreeable to grant Clearcoll an option to
acquire an exclusive world-wide licence to use the Praxis
Polysaccharides in the Field on the terms of this agreement.
AGREEMENT
1. MEANING OF WORDS
1.1 DEFINITIONS
In this agreement:
`BACKGROUND IPR' means any IPR created independently of the Project
which Praxis or Clearcoll makes available to carry out the Project and
includes at the date of this agreement the Background IPR of each party
described in the Project Plan.
`CONFIDENTIAL INFORMATION' of a party means any information that is:
(a) by its nature confidential;
(b) is designated by a party as confidential at the time it is
communicated to the other party; and
(c) is communicated by the one party to the other party in writing or,
in the event that it is communicated verbally, is confirmed in
writing within 20 days of such verbal communication, such
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written communication or confirmation being marked "confidential".
'FIRST RIGHT OF REFUSAL PERIOD' means [insert period] from the grant of
the right of first refusal under CLAUSE 6.6.
`INTELLECTUAL PROPERTY RIGHTS' OR 'IPR' means all intellectual property
rights, including:
(a) patents, plant breeder's right, copyright, rights in circuit
layouts, registered designs, trade marks, and any right to have
confidential information kept confidential; and
(b) any application or right to apply for registration of any of the
rights referred to in (a).
`IPR COSTS' means the fees, costs and expenses of obtaining and
maintaining registered IPR protection for IPR, including patent
attorney and legal fees.
'PROJECT' means the project described in the Project Plan.
'PROJECT PLAN' means the project plan in the Schedule to this
agreement.
`PROJECT IPR' means any IPR developed during and as a result of
carrying out the Project.
`PROJECT RESULTS' means the Deliverables and the Project IPR.
The following words have the meaning ascribed to them in the Project
Plan: PROJECT MEETINGS, TASKS, MILESTONES and DELIVERABLES.
1.2 INTERPRETATION
In this agreement, unless the contrary intention appears:
(a) headings are for ease of reference only and do not affect the
meaning of this agreement;
(b) the singular includes the plural and vice versa and words importing
a gender include other genders; and
(c) other grammatical forms of defined words or expressions have
corresponding meanings.
2. PROJECT
2.1 BACKGROUND IPR
Each Party:
(a) retains ownership of its Background IPR;
(b) grants the other party a non exclusive, non transferable, royalty
free licence to use its Background IPR to the extent necessary to
enable the other party to carry out its obligations under this
agreement; and
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(c) may only use any Background IPR of the other party outside the
Project if it obtains prior written consent from that party.
2.2 WORKING TOGETHER
Each party must:
(a) ensure that its Personnel carry out the Tasks allotted to it:
(i) in accordance with the Project Plan; and
(ii) with due professional care and skill;
(b) attend Project Meetings as set out in the Project Plan; and
(c) supply the other party promptly with information the other party
reasonably requires so that it is not delayed in performing its
obligations under this agreement.
2.3 INDEPENDENT ACTIVITIES
Each party acknowledges that the other party may carry out research,
development and commercial exploitation independently of the Project.
3. REPORTS
3.1 SUBMISSION
Each party must submit to the Management Committee at each Milestone
a `Milestone Report', as set out in the Project Plan specifying:
(a) the Tasks performed for the Milestone; and
(b) any Project IPR generated.
3.2 FINAL REPORT
Within 30 days after the final Milestone, or, in the case of early
termination, within 30 days after termination, the parties must submit
a `Final Report' to the Management Committee specifying all tasks
performed during the Project and all Project IPR generated.
3.3 INFORMATION EXCHANGE
Each party must provide all information requested by the other party to
enable the other party to prepare the reports.
4. MANAGEMENT COMMITTEE
4.1 ESTABLISHMENT
The parties must set up a Management Committee of equal representation:
(a) to be responsible for the overall relationship between the parties;
and
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(b) to oversee the Project.
4.2 REPRESENTATIVES
Each party:
(a) must appoint at least two representatives (`RESEARCH COORDINATORS')
acceptable to the other party as its representatives on the
Management Committee;
(b) subject to the other party's approval, may replace a representative
by giving reasonable prior notice to the other party; and
(c) may appoint an alternate person to act as its representative at a
meeting but only if it notifies the other party at least 24 hours
before the relevant meeting.
4.3 MEETINGS
The Research Coordinators will arrange meetings of the Management
Committee at each Milestone or more frequently if mutually agreed, to:
(a) oversee the conduct of the Project;
(b) review the Project at least every two months;
(c) consider Milestone Reports;
(d) discuss and recommend to the parties any proposed variations to any
aspect of the Project; and
(e) manage the Project IPR, including by:
(i) identifying and notifying the parties of existing and future
Project IPR;
(ii) making recommendations about which Project IPR should be:
(A) retained as Confidential Information; or
(B) protected by patent or any other form of IPR protection.
4.4 CHAIR
Praxis will appoint the Chair of the Management Committee who must
ensure that for each meeting:
(a) where possible, an agenda is circulated in advance; and
(b) minutes are kept and promptly circulated to each party.
4.5 QUORUM
The quorum for meetings of the Management Committee is at least one
representative of each party. All decisions of the Management Committee
are to be unanimous. If this is not achievable then clause 19 (Dispute
Resolution) will apply.
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5. PROJECT RESULTS AND IPR
5.1 BACKGROUND IPR
Each party retains ownership of any Background IPR it provides to carry
out the Project.
5.2 DELIVERABLES
The parties acknowledge and agree that Praxis and Clearcoll will own
the Deliverables on creation as tenants in common in equal shares.
5.3 PROJECT IPR
Project IPR shall belong to Clearcoll and Praxis as tenants in common
in equal shares and will be protected as determined by the Management
Committee.
5.4 COMMERCIALISATION
Neither party shall use the Project IP for commercial purposes without
first reaching agreement with the other party as to the terms and
conditions upon which the IP is to be used. In the event that the
parties are unable to agree upon such terms and conditions the matter
shall be referred to mediationwith a mediator registered under the
MEDIATIONS XXX 0000 (ACT) in a genuine effort to reach agreement upon
such terms, and, if such mediation is unsuccessful the matter shall
then be referred to binding arbitration under the ARBITRATION (CIVIL
ACTIONS) XXX 0000. In the event of a disagreement between the parties
as to the proceedures of the Australian Commercial Disputes Centre
shall apply.
6. OPTION
6.1 GRANT
If Clearcoll has undertaken the Project in accordance with this
agreement, Praxis grants Clearcoll an option to acquire an exclusive,
world-wide licence of all intellectual property owned, by or licensed
to, Praxis, including Project IPR, in the Praxis Polysaccharides in the
Field (the 'OPTION').
6.2 EXERCISE OF OPTION
Clearcoll may exercise the Option by notifying Praxis ('Exercise
Notice') at any time within 12 months from the date of delivery of the
Final Report or such further period as is agreed by the parties in
writing (the 'OPTION PERIOD').
6.3 OPTION PERIOD
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Praxis shall not during the Option Period discuss with any third party
any issue relating to the use of the Praxis Polysaccharides in the
Field nor shall it enter into any negotiations to deal with its IP
rights in respect of the use of the Praxis Polysaccharides in the
Field.
6.4 NEGOTIATIONS
Upon Clearcoll exercising the Option, the parties will enter
negotiations in good faith to determine the terms and conditions on
which the licence shall be granted to Clearcoll. The parties
acknowledge and agree that any licence granted to Clearcoll under this
Clause 6 will be based upon the premise that the licensor(s), or all
licensors together in the circumstances that more than one licence is
required to commercialise the technology, shall receive 25% of the
additional profit made by the licensee from the use of the licensed
technology and shall include amongst its terms:
(a) a specified purpose;
(b) a specified term;
(c) a requirement for Clearcoll to pay Praxis licence fees and/or,
royalties and/or milestone payments; and
(d) minimum performance obligations applicable to Clearcoll.
6.5 MEDIATION
In the event that the parties are unable to agree upon such terms
within 3 MONTHS after the date of the Exercise Notice then they will
enter into mediation with a mediator registered under the MEDIATIONS
XXX 0000 (ACT) in a genuine effort to reach agreement upon such terms.
6.6 NO AGREEMENT
In the event that the parties are unable to so agree then Praxis grants
Clearcoll a first right of refusal to an exclusive, non-transferable,
world-wide licence of all intellectual property owned, by or licensed
to, Praxis in the Praxis Polysaccharides in the Field.
6.7 NOTIFICATION
During the First Right of Refusal Period, Praxis must not grant any
third party a licence of some or all intellectual property owned, by or
licensed to, Praxis in the Praxis Polysaccharides in the Field without
first notifying Clearcoll of the terms and conditions on which Praxis
proposes to do so ('PROPOSAL').
6.8 ELECTION
Clearcoll may elect, within 30 days after receiving a Proposal, to
enter into an agreement with Praxis on the terms and conditions of the
Proposal.
6.9 AGREEMENT
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If Clearcoll does not, within 30 days after receipt of a Proposal:
(a) enter into an agreement with Praxis in accordance with clause 6.8;
and
(b) respond to a Proposal;
Praxis may enter into an agreement in relation to the Praxis
Polysaccharides with any other person on terms and conditions no more
favourable to that other person than the terms and conditions of the
Proposal.
7. GOODS AND SERVICES TAX
7.1 INTERPRETATION
Words or expressions used in this clause 7 which are defined in the A
NEW TAX SYSTEM (GOODS AND SERVICES TAX) XXX 0000 (Cth) or, if not so
defined, then which are defined in the TRADE PRACTICES ACT 1974 (Cth),
have the same meaning in this clause.
7.2 GST INCLUSIVE AMOUNTS
For the purposes of this agreement where the expression 'GST inclusive'
is used in relation to an amount payable or other consideration to be
provided for a supply under this agreement, the amount or consideration
will not be increased on account of any GST payable on that supply.
7.3 CONSIDERATION IS GST EXCLUSIVE
Any consideration to be paid or provided for a supply made under or in
connection with this agreement, unless specifically described in this
agreement as 'GST inclusive', does not include an amount on account of
GST.
7.4 GROSS UP OF CONSIDERATION
Despite any other provision in this agreement, if a party ('SUPPLIER')
makes a supply under or in connection with this agreement on which GST
is imposed (not being a supply the consideration for which is
specifically described in this agreement as 'GST inclusive'):
(a) the consideration payable or to be provided for that supply under
this agreement but for the application of this clause ('GST
EXCLUSIVE CONSIDERATION') is increased by, and the recipient of the
supply ('RECIPIENT') must also pay to the Supplier, an amount equal
to the GST payable by the Supplier on that supply; and
(b) the amount by which the GST exclusive consideration is increased
must be paid to the Supplier by the Recipient without set off,
deduction or requirement for demand, at the same time as the GST
exclusive consideration is payable or to be provided.
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7.5 REIMBURSEMENTS (NET DOWN)
If a payment to a party under this AGREEMENT is a reimbursement or
indemnification, calculated by reference to a loss, cost or expense
incurred by that party, then the payment will be reduced by the amount
of any input tax credit to which that party is entitled for that loss,
cost or expense.
That party is assumed to be entitled to a full input tax credit unless
it proves, before the date on which the payment must be made, that its
entitlement is otherwise.
7.6 NEW TAX SYSTEM CHANGES
The Supplier must pay to the Recipient a refund of payments under this
clause calculated as follows:
R=A(1+B)
Where:
'R' is the amount of the refund;
'A' is the Supplier's calculation of the amount of savings realised
by the Supplier during the New Tax System transition period as a
result of the New Tax System changes in respect of any supply under
this agreement; and
'B' is the rate of GST applicable at the date of the calculation
(expressed as a decimal).
8. CONFIDENTIAL INFORMATION
8.1 OBLIGATIONS
Each party shall in relation to the Confidential Information of the
other:
(a) keep it confidential;
(b) use it only as permitted under this agreement and only disclose it
to employees, contractors and agents who have a need to know;
(c) not copy it or any part of it that is in material form other than
as strictly necessary and must xxxx any such copy `Confidential -
(Discloser)';
(d) promptly comply with any request by the Discloser to return or
destroy any or all copies of Confidential Information unless
required by law to be retained;
(e) implement security practices against unauthorised copying, use and
disclosure (whether that disclosure is oral, in writing or in any
other form); and
(f) immediately notify the Discloser if the Recipient becomes aware of
any:
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(i) unauthorised copying, use or disclosure in any form; or
(ii) disclosure required by law.
8.2 EXCEPTIONS
The obligations in this clause 8 do not apply to the extent that
Confidential Information:
(a) was already in the public domain before disclosure to the recipient
party;
(b) subsequently becomes available in the public domain through no
fault of the recipient party;
(c) can be shown to have already been in the possession of the
recipient party before disclosure to the recipient party;
(d) is provided to recipient by a third party who has no obligation of
confidence to the disclosing party; or
(e) is obliged to be disclosed by Law.
9. WARRANTIES
9.1 PRAXIS WARRANTIES
Praxis warrants that:
(a) it is free to enter into this agreement,
(b) at the date of this agreement, it knows of no reason why any
license which it holds in respect of the Praxis Polysaccharide may
be terminated by the licensor thereof; and
(c) at the date of this agreement, it knows of no third party
intellectual property which would be infringed by the use of the
Praxis Polysaccharides in the Field.
9.2 CLEARCOLL WARRANTIES
Clearcoll warrants that:
(a) it is free to and has all necessary power to enter into this
agreement; and
(b) at the date of this agreement, it knows of no third party
intellectual property which would be infringed by the use of
Clearcoll's Background IPR other than claim 11 of US Patent
6,031,017 and its foreign.
10. END OF AGREEMENT
10.1 END OF TERM
Unless the parties agree otherwise this agreement will end on the
expiry of the last to expire of any patents granted on Praxis
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Polysacharides or Project IPR or 10 years from the date hereof,
whichever is the later.
10.2 EARLIER TERMINATION
Either party may end this agreement immediately by giving notice to the
other party if that other party:
(a) breaches any provision of this agreement and fails to remedy the
breach within 30 days after receiving notice requiring it to do so;
and
(b) breaches a material provision of this agreement where that breach
is not capable of remedy.
10.3 INSOLVENCY
Each party may end this agreement immediately by giving notice to the
other party if any of the following events happen to the other party:
(a) there is a change in the direct or indirect beneficial ownership or
control of the party which would affect its ability to comply with
its obligations under this agreement;
(b) it disposes of the whole or any part of its assets, operations or
business other than in the ordinary course of business;
(c) it ceases to carry on business;
(d) it ceases to be able to pay its debts as they become due;
(e) any step is taken by a mortgagee to take possession or dispose of
the whole or any part of its assets, operations or business;
(f) any step is taken to enter into any arrangement between the party
and its creditors;
(g) any step is taken to appoint a receiver, a receiver and manager, a
trustee in bankruptcy, a liquidator, a provisional liquidator, an
administrator or other like person of the whole or any part of its
assets or business; or
(h) where the party is a partnership, any step is taken to dissolve, or
which has the effect of dissolving, that partnership.
11. AFTER END OF AGREEMENT
After the end of the agreement:
(a) the licence ceases;
(b) Clearcoll must immediately stop using the Praxis Polysaccharides if
doing sop would infringe any subsisting IPR of Praxis;
(c) each party's (the `FIRST PARTY') right to use Confidential
Information of the other party ceases and the first party must
immediately at the other party's request and option:
(i) return to the other party;
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(ii) destroy and certify in writing to the other party the
destruction of; or
(iii) destroy and permit the other party to witness the destruction
of
all of the other party's Confidential Information in the first
party's possession or control;
(d) clauses 5 (Project Results and IPR), 8 (Confidential Information)
and 9 (Warranties) continue; and
(e) accrued rights or remedies of either party are not affected.
12. UNEXPECTED EVENTS
12.1 DEFINITION
`UNEXPECTED EVENT' affecting a party means anything outside that
party's reasonable control, including but not limited to, acts or
omissions of the other party, fire, storm, flood, earthquake, war,
transportation embargo or failure or delay in transportation, act or
omission (including laws, regulations, disapprovals or failures to
approve) of any third person (including but not limited to,
sub-contractors, customers, governments or government agencies).
12.2 CONSEQUENCES
No party is liable for any failure to perform or delay in performing
its obligations under this agreement if that failure or delay is due to
an Unexpected Event. If that failure or delay exceeds 3 months, the
other party may, by notice, terminate this agreement with immediate
effect. This clause does not apply to any obligation to pay money.
13. GENERAL
13.1 GOVERNING LAW
This agreement shall be governed by and interpreted under the Laws of
the State of New South Wales, Australia.
13.2 NOTICES
A party notifying or giving notice under this agreement must give
notice in writing to the last known mail, facsimile or e-mail address
of the recipient party.
13.3 RELATIONSHIPS
This agreement does not create a relationship of employment, agency or
partnership between the parties.
13.4 FURTHER ACTION
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Each party must do or cause to be done all things necessary or
desirable to give effect to, and refrain from doing things that would
hinder performance of, this agreement.
13.5 ASSIGNMENT
A party must not assign or attempt to assign or otherwise transfer any
right arising out of this agreement without the written consent of the
other party.
13.6 WAIVER
The failure of a party at any time to insist on performance by the
other party of any obligation under this agreement is not a waiver of
its right:
(a) to insist on providing of, or to claim damages for breach of, that
obligation unless that party acknowledges in writing that the
failure is a waiver; and
(b) at any other time to insist on performance of that or any other
obligation of the other party under this agreement.
13.7 SEVERABILITY
If part or all of any clause of this agreement is illegal or
unenforceable it will be severed from this agreement and will not
affect the continued operation of the remaining provisions.
13.8 ENTIRE AGREEMENT
This agreement:
(a) records the entire agreement between the parties and supersedes all
earlier agreements and representations by the parties about its
subject matter; and
(b) may only be altered in writing signed by both parties.
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SIGNED for CLEARCOLL PTY LTD by an authorised officer ) /s/ XXXXXXXX XXXXX
in the presence of ) ------------------------------------------------------
) Signature of officer
/s/ XXXXXX XXXXXXX XXXXXXXX XXXXX
-------------------------------------------------------- ------------------------------------------------------
Signature of witness Name of officer (print)
XXXXXX XXXXXXX DIRECTOR
-------------------------------------------------------- ------------------------------------------------------
Name of witness (print) Office held
SIGNED for PRAXIS )
PHARMACEUTICALS ) /s/ XXXXX XXXXXXXX
ININTERNATIONAL PTY LTD by ) ------------------------------------------------------
an authorised officer in the presence of Signature of officer
/s/ XXXXXXX XXXXXXX XXXXX XXXXXXXX
-------------------------------------------------------- ------------------------------------------------------
Signature of witness Name of officer (print)
XXXXXXX XXXXXXX DIRECTOR
-------------------------------------------------------- ------------------------------------------------------
Name of witness (print) Office held
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SCHEDULE TOPICAL PRODUCT
PROJECT PLAN
BACKGROUND Praxis has discovered novel dermal actions of mono
and polysaccharides and Clearcoll may provide
permeation enhancement technology which will make
these polysaccharides permeate into the dermis.
OBJECTIVES To produce topical formulations of Praxis
polysaccharides suitable for commercial
distribution from which the Polysaccharides will
permeate into the dermis and to document the in
vivo effects of these topically applied
Polysaccharides in animals and in humans.
BACKGROUND IPR FROM CLEARCOLL FROM PRAXIS
SKIN PERMEATION Praxis saccharides with dermal structure
ENHANCEMENT OF modifying activity
PARTICES LESS THAN
20UM IN SIZE
START DATE 1ST MAY 2001
COMPLETION DATE DATE ON WHICH PROJECT IS DUE TO END
TASKS Task Responsibility Timeframe
Provision of sufficient Praxis 3 mths
quantities of Praxis
polysaccharide in particles
less than 20um in size to
Clearcoll for production of
topical formulations
Provision to Praxis of
topical formulations for Clearcoll 1 month
transdermal penetration
testing
Transdermal testing
Praxis 3 mths
Animal study of dermal
effects Praxis 3 mths
Protocol for human safety
and efficacy effects Clearcoll/Praxis 2 months
Human safety and
Clearcoll 6 months
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efficicacy studies
Stability studies
Clearcoll 6 months
MILESTONES Milestone Milestone Date
Production of topical formulations 1/8/01
Completion of skin permeation testing 1/12/01
Completion of animal studies 1/12/01
Completion of human safety and efficacy studies 1/8/02
DELIVERABLES Formulas of topical products containing Praxis Polysaccharide which
successfully allow transdermal penetration
Report on transdermal penetration studies
Protocol for human safety and efficacy studies
Report on human safety and efficacy studies
Report on stability studies
PROJECT MEETINGS Meeting after completion of transdermal penetration studies to discuss protocol for
human safety and efficacy studies
Meeting after completion of human safety and efficacy studies
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SCHEDULE INJECTABLE PRODUCTS
PROJECT PLAN
BACKGROUND Praxis has discovered novel dermal actions of mono
and polysaccharides and Clearcoll is in the
business of researching and developing dermal
fillers and the manufacturing and distribution of
cosmetic medical products to physicians.
OBJECTIVES To produce fillers which will produce long term
effects through new collagen deposition and which
will be acceptable to physicians and their patients
and to document these effects.
BACKGROUND IPR FROM CLEARCOLL FROM PRAXIS
METHOD OF PRODUCING
CROSSLINKED HYALURONIC ACID Saccharides with dermal structure
BIOMATERIALS SUITABLE FOR modifying activity
USE AS DERMAL FILLING
MATERIALS
START DATE 1ST MAY 2001
COMPLETION DATE DATE ON WHICH PROJECT IS DUE TO END
TASKS Task Responsibility Timeframe
Production of sufficient Praxis 3 mths
quantities of Praxis
polysaccharide for dermal
filler studies
Production of covalently Clearcoll 3 mths
bound crosslinked
hyaluronic acid/Praxis
polysaccharide material
Production of GLP or GMP 6 mths
validated 1ml syringes of Praxis/Clearcoll
solutions of Praxis
polysaccharide with and
without HA in various
concentrations
Toxicity testing including 6 mths
cytotoxicity, Praxis
sensitisation,
genotoxicity,
carcinogenicity and
implantation studies
2 mths
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Protocol for human pilot
study Praxis
4 months
Ethics Committee approval
for human pilot study Praxis/Clearcoll
Human pilot study 6 mths
Protocol for human safety Clearcoll 2 months
and efficacy study
Clearcoll/Praxis
Ethics Committee approval 4 mths
for human safety and
efficacy study of Praxis
polysaccharide with and Praxis/Clearcoll
without HA
Human safety and efficacy
study 12 months
Clearcoll
MILESTONES Milestone Milestone Date
Production of HA/Praxis polysaccharide 1/9/01
Production of GLP/GMP materials for testing 1/4/02
Completion of toxicity testing 1/10/02
Completion of human pilot study 1/4/03
Completion of human safety and efficacy studies 1/10/04
DELIVERABLES Report on toxicity testing Protocol for human pilot
study Report human pilot study Protocol for human
safety and efficacy study Report on human safety
and efficacy study
PROJECT MEETINGS Meeting upon completion of toxicity testing
Meeting upon completion of human pilot study
Meeting upon completion of human safety and efficacy study
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