Exhibit 4.2
[***] - INDICATES MATERIAL
THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
COMMISSION PURSUANT TO RULE
24B-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE
ACT OF 1934, AS
AMENDED.
PSIONCOLOGY PTE. LTD.
- and -
SINGAPORE GENERAL HOSPITAL PTE. LTD.
- and -
SGH TECHNOLOGY VENTURES PTE. LTD
================================================================
COLLABORATION AGREEMENT
================================================================
<PAGE>
THIS AGREEMENT is made as of
the 24th day of July 2002
BETWEEN:
1 PSIONCOLOGY PTE.
LTD. a company
incorporated under the
laws of Singapore
and whose
registered
office is at 80
Robinson Rd, #17-02, Singapore,
068898.
("PSIONCO"); and
2 SINGAPORE
GENERAL HOSPITAL PTE
LIMITED a company
incorporated under
the
laws of
Singapore and whose registered office is at 11 Third Hospital
Avenue,
#07-00 SNEC Building, Singapore 168751 ("SGH"); and
3 SGH TECHNOLOGY
VENTURES PTE LIMITED a company incorporated under the
laws
of
Singapore with
registration number
200205889D
and whose registered
office is
at 11 Third Hospital
Avenue, #07-00 SNEC
Building, Singapore
168751
("SGHT").
PRELIMINARY
(1) By a Subscription and Shareholders Agreement between SGHT, pSiMedica
Limited (a
company incorporated
under the name of Forceglass Limited on 5
July, 2000
with a registered number 4027099 and whose registered office
is
at One,
St. Paul's Churchyard,
London EC4M 8SH)
("PSIMEDICA"),
Biotech
Research
Ventures Pte Ltd (a company incorporated under the laws of
Singapore
under number 200101402W of registered office, 24a Duxton Hill,
Singapore
089607
("BRV")) and pSiOnco, of even date (the "SHARE
SUBSCRIPTION
AGREEMENT"), it was
agreed that SGHT and pSiOnco, together
with SGH
would execute this Agreement upon its terms and
conditions.
(2) By a Patent and Know-how
Licence Agreement
between (1) pSiMedica
and (2)
pSiOnco of
even date, pSiMedica
granted pSiOnco a limited licence
under
the
pSiOnco Patents and pSiOnco Know-how to research, discover, develop,
manufacture, have
manufactured, use
market and sell within the Field the
pSiOnco
Materials together with the right to grant sub-licences within
the
Field (the
"PATENT AND KNOW-HOW LICENCE")
<PAGE>
-2-
NOW IT IS HEREBY AGREED AS
FOLLOWS:
1. DEFINITIONS AND
INTERPRETATION
1.1
In this Agreement and in the Schedules to this Agreement the
following words and phrases shall have the following meanings
unless
the context requires otherwise:
"Agreement" the terms and
conditions set out in
this document
and any and all Schedules and Appendices attached
to it as the same may be varied from time to time
in accordance
with
the Change of Research
Programme Procedure;
"Board"
the board of directors for the time being of
psiOnco;
"Business
Day"
a day other than a
Saturday, Sunday, or public
holiday in Singapore;
"Chairman" the chairman of the Joint Research Committee,
appointed in
accordance
with
the Share
Subscription Agreement;
"Change" a
change to the Research Programme or the services
provided in
accordance
with this Agreement to
which the Change of Research Programme Procedure
applies;
"Change of
Research
Programme
Procedure" the procedure
set out in Clause 14.1 to 14.3;
"Chemotherapy
Agents"
Generic Chlorambucil
or its generic
variants and
generic
5-Flourouracil
(5FU) or its generic
variants and/or such other chemotherapy agents as
agreed with
pSiOnco
from
time to time in
accordance with the
Change of Research
Programme
Procedure;
<PAGE>
-3-
"Commencement
Date"
the date first written above;
"Competent
Authority" any local or national agency, authority,
department,
inspectorate,
minister,
ministry
official or public or
statutory person
(whether
autonomous or
not) of any country or of any
government of any country having jurisdiction over
the Agreement
or any of the
Parties or over
the
development or
manufacture
or marketing of
medicinal products
including but not limited to
the Health Sciences Authority of Singapore;
"Documents" paper, notebooks,
books, files, ledgers,
records,
tapes, discs,
diskettes,
CD-ROM and any other
media on which Know How can be permanently stored;
"Field"
intra-tumoural radiotherapy using the Radiotherapy
Agents and
chemotherapy
using the Chemotherapy
Agents where the therapy is applied interstitially
within the
tumour (and not in any other matter
parenterally or otherwise) which for the avoidance
of doubt avoids introduction via the vasculature;
"Force
Majeure" in
relation to any Party any event or circumstance
which is beyond the
reasonable
control of that
Party, which that
Party could not
reasonably
be
expected to
have taken into account at the
Commencement Date and
which results in or
causes
the failure of that Party to perform any or all of
its obligations under this Agreement including an
act of God, lightning, fire, storm, flood,
earthquake,
accumulation of snow
or ice, lack of
water arising
from weather or environmental
problems, strike,
lockout or other industrial
disturbance arising in
relation to the work force
of a Third Party, war,
terrorist act,
blockade,
revolution, riot
insurrection,
civil
commotion,
public demonstration,
sabotage, act of vandalism,
prevention from or
hindrance in obtaining
in any
way materials,
energy
or other supplies,
explosion, fault or failure of plant or machinery,
governmental
restraint, act of
legislature
and
directive or requirement of a Competent Authority
governing any Party,
provided that lack of
funds
shall not be
interpreted as a cause
beyond the
reasonable control of that Party;
<PAGE>
-4-
"Group" in
relation to any person, being a corporate body,
that person
any "subsidiary" thereof, or any
"holding company"
thereof or "subsidiary" of such
"holding company" as
defined in the Companies Act
Cap 50;
"Intellectual
Property" copyright
and related
rights, database rights,
design rights, trade
marks, trade names,
service
marks, domain
names, Patent Rights, Know How,
Materials and other
such intellectual property
rights existing now or
in the future anywhere
in
the world (whether
registered or not) and any and
all applications or renewals for such rights;
"Joint
Research
Committee" the committee
established pursuant to Clause 4;
"Know How" unpatented
technical and other information related
to or useful
in the Field which is not in the
public domain
including,
ideas,
concepts,
inventions, discoveries,
data,
formulae,
specifications,
information relating to Material,
procedures for
experiments and tests
and results
of
experimentation
and testing,
results
of
research and
development
including
laboratory
records and data analyses;
<PAGE>
-5-
"Material" any chemical or
biological substances
related to
or useful in the Field including, but not limited
to any:
(a)
organic or inorganic chemical element or
compound;
(b)
amino acid, amino acid sequence, peptide
or protein;
(c)
nucleotide or
nucleotide
sequence
including DNA and RNA sequences;
(d)
vector or construct
including plasmids,
phages or viruses; or
(e)
assay or reagent;
"Parties" SGH,
pSiOnco and SGHT and a "Party" shall be
construed accordingly;
"Patent
Rights"
to the extent
related to or useful
in the Field,
patent applications, patents, author certificates,
inventor
certificates,
utility
certificates,
improvement patents and models and certificates of
addition and all foreign counterparts of them
and
includes all divisions, renewals, continuations,
continuations-in-part, extensions,
reissues,
substitutions, confirmations,
registrations,
revalidations and additions of or to them, as well
as any supplementary
protection
certificate,
or
like form of protection, in respect thereof
existing now or in
the future anywhere in the
world;
<PAGE>
-6-
"pSiOnco
Intellectual
Property" the
pSiOnco Patent
Rights, pSiOnco Know How and
pSiOnco Material;
"pSiOnco
KnowHow" the
Know How in the Field
owned by or licensed to
pSiOnco as set out in Schedule 2;
"pSiOnco
Material" the
Materials in the Field owned by or licensed to
pSiOnco as set out in Schedule 3;
"pSiOnco
Patent
Rights"
the Patent
Rights in the Field owned by or
licensed to pSiOnco as
set out in Schedule 4
and
all Patent Rights arising therefrom;
"Programme
Intellectual
Property" Any
Intellectual
Property
arising
from the
Research Programme
carried out by the Research
Group during the Research Term;
"Radiotherapy
Agents"
isotopes of
Phosphorous and
isotopes of
Yitrium
and/or such other
agents as agreed with
pSiOnco
from time to time in accordance with the Change of
Research Programme Procedure;
"Research
Group"
that part of the Department of Experimental
Surgery at SGH which is undertaking the Research
Programme and
which is directed by Dr. Pierce
Chow;
"Research
Programme" the programme of
research set out in Schedule 1 as
may be amended
from time to time in accordance
with the Change of Research Programme Procedure;
<PAGE>
-7-
"Research
Term"
the period during
which the Research Programme
will be undertaken
as set out in
Clause 3.1 or
such other period as
may be amended from
time to
time in accordance
with the Change of Research
Programme Procedure;
"SGHT
Intellectual
Property" the
Intellectual Property
owned by or licensed to
SGHT and SGH as set out in Schedule 5; and
"Third
Party"
any entity or person
other than the Parties
or a
member of a Party's Group.
1.2
In this
Agreement:
1.2.1 unless the
context otherwise requires, all references to a
particular clause or
schedule shall be a reference to that
clause or schedule
in or to this
Agreement as it may be
amended from time to time pursuant to this Agreement;
1.2.2 the table of contents and headings are inserted for
convenience only and
shall be ignored in
construing
this
Agreement;
1.2.3 unless the
contrary intention appears, words importing the
masculine gender shall
include the feminine and vice versa
and words in the
singular include the plural and vice
versa;
1.2.4 unless
the contrary intention appears, words denoting
persons shall include any individual, partnership,
company,
corporation, joint venture, trust association,
organisation
or other entity, in each case whether or not having
separate legal personality;
1.2.5 the words
"include",
"included" or
"including" are to
be
construed without
limitation
to the specifics of the
subsequent words;
<PAGE>
-8-
1.2.6 reference
to any statute or regulation includes any
modification or re-enactment of that statute or
regulation;
and
1.2.7 references
to each of pSiOnco,
SGH and SGHT shall
include
references to each of their permitted successors in title
and assigns.
2. RESEARCH
LICENCES
2.1
SGHT and
SGH hereby grants to
pSiOnco and SGH any
and all rights
and permissions
required to
undertake the Research Programme
whether at the premises of SGH or elsewhere including any
licences
required under any and all SGHT Intellectual Property and to the
extent that
the use of such SGHT Intellectual Property is
necessary to research,
develop, manufacture,
have
manufactured,
use, market and sell
the Programme
Intellectual Property,
SGHT
hereby grants pSiOnco a royalty-free, perpetual licence to use
the
SGHT Intellectual Property for such purposes.
2.2
pSiOnco
hereby grants to SGH a non-transferable, royalty free,
non-exclusive licence
under the pSiOnco Intellectual Property and
any Programme
Intellectual Property
assigned to pSiOnco pursuant
to Clause 7.1 for the purpose of carrying out SGH's tasks in the
Research Programme within the Field.
3. RESEARCH
PROGRAMME
3.1
SGH
hereby undertakes to provide the services required to
undertake the Research Programme as set out in Schedule 1
(subject
to any variation
thereto agreed in
writing by SGH and pSiOnco in
accordance with the Change of Research Programme Procedure) with
all reasonable
skill and care for a
period of twenty
four (24)
months from the Commencement Date (the "RESEARCH TERM");
3.2
In
connection with the provision of the services under this
Clause
3 SGH shall
only use such
employees or persons as have been
approved in advance in writing by pSiOnco for these purposes,
and
SGH shall provide pSiOnco with copies of the resumes of its
employees who are to undertake any part of the Research
Programme
and form part of the Research Group. For the avoidance of doubt
pSiOnco agrees to the use of the individuals identified by name
as
approved in Schedule 1 who shall form the initial Research
Group;
<PAGE>
-9-
3.3
SGH shall
ensure that all employees or persons used by SGH to
perform the Research
Programme (including,
without limitation,
those in the Research Group) shall be bound by provisions
equivalent to
those regarding confidentiality (Clause 10),
publications (Clause
11), non-compete
(Clause 9.2) and ownership
of intellectual property (Clause 7) as set out in this Agreement
.
3.4
Each of
SGH and pSiOnco shall
keep or cause to be kept Documents
relevant to the
Research Programme, such Documents shall be
maintained separately by SGH from records and notebooks of
results
which are not part of the Research Programme;
3.5
Unless
otherwise agreed between SGH and pSiOnco in writing,
neither SGH nor pSiOnco shall be under any obligation to provide
additional resource or
facilities in connection with the Research
Programme over and above that agreed pursuant to this Clause 3
or
as set out in the Research Programme;
3.6
pSiOnco
acknowledges
that SGH is in receipt of funds from
charitable and
governmental
organisations to carry
out research
and that SGH is
contractually obliged
to carry out that research
in accordance
with the relevant
terms of that
funding. In the
light of this, pSiOnco
agrees that those
employees of SGH funded
by the said non-commercial organisations shall, at all times, be
free to pursue the research for which they have been funded and
so
long as research
conducted by members of the Research Group does
not conflict with or reduce or in any way diminish any proposed
or
anticipated
contribution by the
Research Group to the Research
Programme.
3.7
If either
of SGH or pSiOnco requires a licence to any Intellectual
Property owned by a person other than the Parties or any member
of
a Party's Group for the purposes of the Research Programme, this
shall first be discussed by the Joint Research Committee, but no
Party shall enter into a licence for that Intellectual Property
without the prior
consent of
pSiOnco. To the extent that such
Intellectual Property
is owned by a Party
but not licensed to
either SGH or pSiOnco pursuant to this Agreement, then that Party
shall, do, or procure to be done, all further acts and execute
and
deliver, procure to be
executed and
delivered, all such
further
documents and instruments as shall be required in order for SGH
or
pSiOnco to use such Intellectual Property. Neither Party shall be
in breach of this
Agreement where it is
unable to carry out part
of the Research
Programme because to do so without such a licence
would infringe the Intellectual Property rights of a person
other
than the Parties unless they were aware of the need for
such
licence at the date of this Agreement.
<PAGE>
-10-
3.8
SGH shall
not delegate to any third party the performance of the
Research Programme without the prior written consent of
pSiOnco;
3.9
SGH shall
have no power to enter into any agreement or accept any
commitments, liability or similar on behalf of pSiOnco.
4. JOINT RESEARCH
COMMITTEE
4.1
Immediately following
the execution of this Agreement SGH and
pSiOnco shall establish the Joint Research Committee in
accordance
with Clause 4.3 to oversee and manage the Research
Programme.
4.2
The Joint
Research Committee
will provide a framework for project
management and
communication
between
pSiOnco
and SGH. In
particular, the Joint Research Committee shall:
4.2.1 subject to the
provisions of this
Agreement and the
Share
Subscription Agreement allocate the work under the
Research
Programme as appropriate (taking into account the
manpower,
facilities and
equipment available to each of SGH and
pSiOnco);
4.2.2 monitor
progress against the agreed milestones and the
timetable of the Research Programme;
4.2.3 promote
and ensure
the due performance of the Research
Programme;
<PAGE>
-11-
4.2.4 advise and
assist in the
resolution of any
scientific
or
technical difficulties
which are experienced by either SGH
or pSiOnco personnel engaged on the Research Programme;
4.2.5 review the
results of the Research Programme with a view to
identifying any
patentable
inventions
and consider
opportunities for publications and patent filings, subject
to the provisions of this Agreement and the Share
Subscription Agreement;
4.2.6 prepare
quarterly reports for submission to the Board, and
4.2.7
subject always to Clause 2 propose to the Board and SGH
amendments to the Research Programme from time to time as
may be necessary
or desirable which shall be agreed in
accordance with the Change of Research Programme
Procedure;
PROVIDED ALWAYS that the Joint Research
Committee shall have no power to
bind
either pSiOnco or SGH and decisions reached by it shall be treated only as
proposals or recommendations to the Board of pSiOnco and to SGH unless
specifically agreed otherwise
in writing.
4.3 The Joint Research Committee shall be established and run by SGH and
pSiOnco as follows:-
4.3.1 The Joint Research Committee shall comprise six (6) members
("Members") comprising
three (3) appointees
from each of SGH and
pSiOnco. The initial Members of the Joint Research Committee
shall
be as follows:
SGH MEMBER
PSIONCO
MEMBER
Pierce Chow
Leigh Canham
Kai Zhang
Steve Connor
Robert Tech Hin
Roghieh Safie
<PAGE>
-12-
4.3.2 In addition to
the three SGH Members SGH may invite an employee or
representative of SGH
(an "INVITEE")
to meetings of the Joint
Research Committee if
in SGH's opinion the
attendance
of a SGH
employee or representative is desirable in relation to one or
more
items on the agenda of the relevant meeting or for the purpose
of
properly advising SGH in relation to matters under this
Agreement.
Prior to any such meeting SGH shall inform pSiOnco in writing of
the SGH employee or representative who will be in
attendance.
4.3.3 In addition to
the three pSiOnco
Members, pSiOnco may invite an
additional employee or representative of pSiOnco (an "INVITEE")
to
meetings of the Joint Research Committee if in pSiOnco's
opinion
the attendance
of such pSiOnco employee or representative is
desirable in
relation to one or more items on the agenda
of the
relevant meeting or
for the purpose of
properly advising it in
relation to
matters under this Agreement. Prior to any such
meeting pSiOnco
shall inform SGH in writing of the pSiOnco
employee or representative who will be in attendance.
4.3.4 Each of SGH and
pSiOnco shall be entitled to remove any Member
appointed by it and to
appoint any person to fill a vacancy
arising from the removal or retirement of such Member. Each Party
shall give the others prior written notice of any proposed
changes
in the identity of their Members.
4.3.5 The Parties
shall use all
reasonable
endeavours
to ensure
that
their appointed
Members and/or Invitees are of a level of
expertise and
seniority to deal with the issues that may arise in
connection with the Research Programme.
4.3.6 The Joint Research Committee shall meet forthwith following the
Commencement Date and
thereafter shall hold
regular meetings
at
intervals of not more
than four (4) months and at any time during
normal business
hours on any
Business Day upon the request of
either SGH or pSiOnco.
<PAGE>
-13-
4.3.7 The venue for
all meetings shall be in Singapore, unless otherwise
agreed, in which case
(where the meeting
does not take place
in
Singapore at the request of pSiOnco) pSiOnco shall bear all
travel
and subsistence costs incurred by SGH's Members in connection
with
their attending the
meeting in question. A
Member or Invitee may
attend by telephone
or video conference provided that all the
Members present can hear all parts of the proceedings.
4.3.8 At least
fourteen (14) days' written notice of each meeting of
the
Joint Research
Committee shall be given to each
Member by the
Party convening the meeting.
4.3.9 The quorum for
meetings of the Joint Research Committee shall be
four (4) Members
provided at least two
(2) Members from each
of
SGH and pSiOnco are
present. Members may
be represented
at any
meeting by
another Member designated in writing by the
absent
Member. Members
attending by
telephone or by video conference
shall for the avoidance of doubt count in the quorum.
4.3.10 The chairman of
the Joint Research
Committee (who shall be the
research director of
the Research Group or in his absence another
member of the Joint Research Committee) shall be responsible
for
the preparation
of the minutes of each meeting of the Joint
Research Committee. A copy of the minutes of each meeting shall
be
sent to each of the
Members within fourteen (14) days of the
meeting which they
record. The minutes for a meeting shall be
approved by the Joint Research Committee at the next
meeting.
4.3.11 The Chairman
of the Joint Research Committee or his or her
designate shall prepare quarterly reports during the Research
Term
summarising in
reasonable
detail the
results of the Research
Programme during the
preceding quarter. Copies of such reports
shall be sent
to the Parties within 30 days of the end of
the
quarter to which they relate.
<PAGE>
-14-
5. RESEARCH
FUNDING
5.1
As a
contribution
to SGH's costs for
carrying out its allotted
tasks under the Research Programme, pSiOnco shall make payments
to
SGH in accordance
with the Research Plan costs outlined in
Schedule 1.
5.2
All
payments shall be made
by pSiOnco in
Singapore dollars on
a
quarterly basis upon
submission
of a valid invoice by
SGH. Such
payments shall be made directly to SGH as directed by
SGH.
5.3
SGH shall
apply the payments
received from
pSiOnco pursuant to
Clause 5.1 exclusively
for the sole
purpose of carrying
out the
Research Programme.
6. ACADEMIC
COLLABORATIONS
6.1
The
Parties acknowledge that it may be desirable to forge
collaborative links
with Third Party
academic groups to
support
the Research
Programme.
In the event that SGH desires such
collaboration, the
opportunity
in question shall be
referred to
the Board for approval of any such collaboration. pSiOnco shall
not unreasonably
hinder the establishment of such links where the
Third Party in question is willing to enter into the
collaboration
on reasonable
terms and where the
results of such
Third Party
collaboration will be available to pSiOnco within the framework
of
the Research
Programme. SGH shall
not, without the prior written
consent of pSiOnco,
encumber any Programme
Intellectual Property
in any such academic collaboration.
6.2
In the
event that pSiOnco desires a collaboration between SGH and
a Third Party, the
opportunity
in question shall be
referred to
the Chief Executive of SGH for written approval and SGH shall
not
unreasonably hinder
the establishment
of such links where the
Third Party in question is willing to enter into the
collaboration
on reasonable
terms and where the
results of such
Third Party
collaboration will be available to pSiOnco within the framework
of
the Research
Programme. SGH shall
not be under any obligation to
accept such a
collaboration which by
way of such a collaboration
with a Third Party
significantly
alters SGH's obligations to
pSiOnco as detailed in this Agreement.
<PAGE>
-15-
6.3
Each Party
shall ensure that no
Documents are published by any
Third Party collaborator unless in accordance with Clause
11.
7. OWNERSHIP AND
MANAGEMENT OF INTELLECTUAL PROPERTY
7.1
SGH and
SGHT hereby assign by way of present and future
assignment
with full title guarantee and free from charges, liens, mortgages
or other encumbrances
of any kind to hold unto pSiOnco absolutely
all their interests in and to any Programme Intellectual Property
and the full and exclusive benefits thereof and rights,
privileges
and advantages associated with them including:
7.1.1 the full
right to apply for and
obtain patents or other
forms of protection
in respect of all or any part of
the
Programme Intellectual Property throughout the world;
7.1.2 the right to
claim priority
from the patent application
included with
any programme Patents under the Paris
Convention (as amended) when making such applications;
7.1.3 the right to file divisional, continuation
and
continuation-in-part applications in its own name in
respect of
subject matter described in the Programme
Patents; and
7.1.4 the right to
recover, and take all
such proceedings as may
be necessary for the recovery of, damages or other forms
of
relief in respect of all infringements of rights in
Programme
Intellectual
Property or
any other rights
assigned under this
Agreement matters
taking place before
or after the Commencement Date.
7.2
SGH and
SGHT hereby
agree to do or
procure to be done all
other
acts and to execute
and deliver all such
further documents
and
instruments as shall
be required to give full effect to the
assignment under
Clause 7.1 or the
recording by pSiOnco
of such
assignment including
by signing
any documents required by any
national patent office or other equivalent registry.
<PAGE>
-16-
7.3
The
prosecution,
maintenance,
defence and enforcement of the
Programme Intellectual
Property shall be the
responsibility
of
pSiOnco save that
pSiOnco shall give copies of all
significant
documents relating
to the same to SGH and
SGHT in order that SGH
and SGHT may keep
records of all relevant events related to the
Programme Intellectual Property.
8
CONSIDERATION
8.1 Subject to the provisions of the Share Subscription Agreement, on
achievement of a
milestone (as detailed in Clauses 8.1.1 to 8.1.3 below)
within the Research Term plus six months, SGHT together with BRV
shall be
entitled to
subscribe for the further number of ordinary shares in
pSiOnco set out in
Clauses 8.1.1 to 8.1.3 below (in the ratio of two
thirds to SGHT and one third to BRV) [***]:
8.1.1 [***] on
completion of pre-clinical studies leading to approval
by
the Ethics Committee
or any other
appropriate committee
for the
first trial in humans;
8.1.2 [***] on
completion of the first clinical trial to test for
safety
in a human; and
8.1.3 [***] on
completion of the first clinical trial to demonstrate
for
efficacy in a human.
8.2 The subscription price per share for such
further tranches of shares
shall be [***].
8.3 Such shares issued in
accordance with this
Clause 8 will be held subject
to
and in accordance with the Share Subscription Agreement and pSiOnco's
articles of association.
8.4 For the avoidance of doubt SGHT and BRV shall not be entitled to
subscribe for any shares under this Clause 8 in respect of the
successful
achievement of (a) particular milestone(s) if such m