Directors' Report
(CON TINUE D)
for in the future, or that the lack of any such patents will not
have a material adverse effect on TyraTech's ability to develop
and market its proposed products or that third parties will not
misappropriate TyraTech's trade secrets and confidential information.
There can be no assurance as to the ownership, validity
or scope of any patents in which TyraTech has an interest or
that claims relating to such patents will not be asserted by
other parties or that, if challenged, such patents will not be
revoked. Even if patent protection is obtained, no assurance
can be given that TyraTech will successfully commercialise the
product or technology prior to expiry of the patent protection.
It is also not certain that extensions of patent protection
(patent term extensions, supplementary protection certificates
or their equivalent around the world) will be available at
the end of the term of patents currently in existence so as to
provide patent protection during the initial period in which
products are marketed. TyraTech may be unable to adequately
protect its proprietary information and know-how. In addition
to its patented technology, TyraTech relies upon unpatented
proprietary technology, processes and know-how. TyraTech
has confidentiality agreements in place with customers, suppliers
and employees who have access to its proprietary information
and know-how, but such agreements may be breached
and TyraTech may not have adequate remedies for such
breach. In addition, TyraTech's trade secrets may otherwise
become known or be independently developed by competitors.
If certain parts of TyraTech's proprietary information and
know-how were to become public knowledge, then the value
of TyraTech's products could be adversely affected which
could have a material adverse effect on TyraTech's business,
financial condition and results of operations.
TyraTech's Ability to Introduce Certain of Its Products to
Market Is Dependent on Successful Completion of Regulatory
Approval Process
Insecticide and parasiticide products are subject to a regulatory
approval process in the US , in Europe and other parts of
the world which is extremely expensive and can take years to
complete. Failure to obtain or maintain regulatory approval
could result in the inability to market and sell such products.
Of particular importance is the requirement, applicable in
most territories, that an approval to market a biocide in the
relevant territory, or an exemption from it, be obtained from
the relevant regulatory authority. Such approval would usually
require the collection and evaluation of data relating to the
quality, safety, efficacy or performance of the product candidate
for its proposed use. The time necessary to obtain regulatory
approval varies among products and between the US ,
Europe and the rest of the world and is affected by numerous
factors many of which are beyond TyraTech's control. There
can be no assurance that regulatory clearance for the product
or, indeed, for trials at each stage and approval for TyraTech's
product candidates still in development will be forthcoming
without delay or at all.
Regulatory Investigations and Litigation May Lead to Fines or
Other Penalties
There is a risk that TyraTech would face regulatory investigation,
if there were data errors in the submission documents
or if new data came out that impacted the claims or safety
profile of any of its products.
Charit able Donati ons
The Group has made charitable donations to local charities
during the year of US $0.4 million (2009: US $0.4 million)
to educational institutions involved in the development of
its technology.
Dir ectors
The Directors who served during the year were as follows:
G.N. Vernon (resigned 10 May 2010)
R.D. Armstrong (resigned 4 January 2010)
K.E. Bigsby (resigned 4 August 2010)
A.J. Reade
B.M. Riley
K.D. Noonan (retired 9 July 2010)
P. Regan (resigned 27 May 2011)
J. Hills (appointed 9 July 2010)
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