tag:blogger.com,1999:blog-79328837481441086102024-02-08T11:16:13.769-08:00Antibiotic Funding ProposalSalchaterohttp://www.blogger.com/profile/08618324316165845094noreply@blogger.comBlogger6125tag:blogger.com,1999:blog-7932883748144108610.post-91614401970285311662023-04-16T13:29:00.001-07:002023-04-16T13:29:05.462-07:00Introduction<p> </p><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">The number of non-human cells in
and on the human body exceeds that of human cells.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">How is this possible?</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">When a person dies, bacteria quickly cause
decay and putrefaction. How does the body prevent bacterial overgrowth during
life?</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">The answer is the human body makes
an antibiotic to control bacterial protein synthesis.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">I know what it is, and how to make it.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">A short history of antibiotics may be
helpful.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Antibiotics, as a class of
medicinal compounds, were first discovered by Paul Ehrlich and Sakahiro Hata in
1910.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">They synthesized the compound
Arsphenamine to treat syphilis.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">In 1928, Sir Alexander Fleming
discovered a compound he named Penicillin. The compound was secreted by the
Penicillium fungus and inhibited bacterial wall protein synthesis. Other drugs
were later added to the list of fungal-derived products with antibiotic
properties.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">During and after 1943, Albert
Schotz and Selman Waksmain isolated the antibiotic Streptomycin from the soil
bacteria genus Streptomyces. Further research on other members of this genus
resulted in the discovery of additional antibiotics.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Most bacterial products
successful in humans target bacterial protein synthesis. This is because the
protein synthetic apparatus of bacteria differs from that of humans. While both
bacterial and human ribosomes are involved in protein synthesis, they differ in
their size, composition, and structure. This allows for the development of
antibiotics that specifically target bacterial ribosomes without affecting
human cells.</span></p><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">While many bacterial products have antibiotic
properties, only a select few are appropriate for human use. The pharmaceutical
industry generally demands a Therapeutic Index of 10 or more before exploring a
new drug.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">My drug, which inhibits MRSA
while sparing yeast mitochondria, has a T.I. of 15.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Another facet contributing to the
success of an antibiotic is the lack of mutagenicity.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">If the compound works by causing mutations in
bacterial DNA it will lead to cell death.</span><span style="font-family: Garamond; font-size: 14pt;">
</span><span style="font-family: Garamond; font-size: 14pt;">This will put pressure on the genome, forcing bacteria to evolve away
from the inhibitor, leading to the antibiotic resistance now seen around the
world.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">The effectiveness of a human
antibiotic cannot be attributed to a mutational mechanism, as evidenced by the
existence of over 7 billion humans. </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">The
human antibiotic must leave bacterial protein synthesis in stasis without
causing bacterial death.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Simultaneously,
it must not inhibit human protein synthesis or cause human cell death.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">My compound exhibits all of these
characteristics at appropriate doses.</span></p>Salchaterohttp://www.blogger.com/profile/08618324316165845094noreply@blogger.com0tag:blogger.com,1999:blog-7932883748144108610.post-5839681594583042442023-04-16T13:26:00.000-07:002023-04-16T13:26:33.700-07:00Robert Bayless C.V.<p> </p><p class="MsoNormal" style="margin-left: 1.5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;">ROBERT K. BAYLESS<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: 1.5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><o:p> </o:p></span><span style="font-family: Garamond; font-size: 14pt;"> </span><st1:street><st1:address><span style="font-family: Garamond; font-size: 14.0pt;">8710 Chisholm Lane</span></st1:address></st1:street></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt;">Austin</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt;">Texas</span></st1:state><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;">
</span></span><st1:postalcode><span style="font-family: Garamond; font-size: 14.0pt;">78748</span></st1:postalcode></st1:place><span style="font-family: Garamond; font-size: 14.0pt;"><o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;"> </span><a href="mailto:Methylgroup@sbcglobal.net">Methylgroup@sbcglobal.net</a><o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>512 280 5687<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">I am an antibiotic researcher who has discovered a
new class of non-mutagenic protein synthesis inhibitors to control bacterial
infections in humans, animals, and plants. I believe that the human body has
evolved an antibiotic to control the overgrowth of bacteria found in the
everyday environment, and I know what it is and how to make it.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"><o:p> </o:p></span></p>
<p class="MsoNormal" style="margin-left: 2.0in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">EXPERIENCE<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: 2.0in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">January 1980 to present: For the last 35 years, I
have been involved in an antibiotic research project. In 1985, I founded and
ran a basic biochemistry research lab with a Stanford Ph.D., who trained me in
the basics of scientific research. We worked together for ten years. I arranged
two clinical trials in cats and dogs to investigate the utility of one of our
compounds. I then collaborated for ten years with an MD who was the chief of
Emergency Medicine at the </span><st1:city><st1:place><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Austin</span></st1:place></st1:city><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">
city hospital. We arranged and performed two human clinical trials using
compounds outlined in my six patents. We had a third trial arranged when he
retired after the hospital was taken private. I then spent five years studying
analytical chemistry with the Ph.D. Director of the Microanalysis Lab at UT
Austin.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">I have successfully synthesized a member of a new
class of antibiotics based on the hypothesis that the human body has evolved a
safe, non-mutagenic protein synthesis inhibitor to control bacteria. The
spectroscopist and I explored and defined the chemical structure of the
antibiotic compound I synthesized as part of my ongoing research. My efforts
now are centered on raising the $5 million necessary to obtain US and worldwide
patents on the compounds and then license their testing, manufacture, and use
to Big Pharma.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"><o:p> </o:p></span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="margin-left: 2.0in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">EDUCATION</span></p><p class="MsoNormal" style="margin-left: 2.0in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><br /></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"><o:p> 1977: Pasted the testing and was accepted into Mensa International.</o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">1972-1973: </span><st1:place><st1:placename><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Pace</span></st1:placename><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span><st1:placetype><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">University</span></st1:placetype><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">
</span><st1:placename><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Graduate</span></st1:placename><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span><st1:placetype><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">School</span></st1:placetype></st1:place><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">
of Business located on the Pleasantville/Briarcliff Campus in upstate </span><st1:state><st1:place><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">New York</span></st1:place></st1:state><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">. I completed one year of a two-year MBA program
but left because they did not offer coursework in entrepreneurship. <o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">1965-1969: Earned a B.A. from The University of
Connecticut located in </span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Storrs</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Connecticut</span></st1:state></st1:place><span style="font-family: Garamond; font-size: 14pt;">.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"><o:p> </o:p></span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;">
</span>PATENTS<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><o:p> </o:p></span><span style="font-family: Garamond; font-size: 14pt;">1)</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Treating AIDS and HIV Infection with
Methionine</span><span style="font-family: Garamond; font-size: 14pt;"> </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14.0pt;">United States</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt;"> 5,292,773 <span class="patents-date">Issued </span></span><st1:date day="8" month="3" year="1994"><span class="patents-date"><span style="font-family: Garamond; font-size: 14.0pt;">March 8, 1994</span></span></st1:date><span class="patents-date"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></span><span style="font-family: Garamond; font-size: 14pt;">2 inventors:</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Robert Bayless and</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Gerald P. Hirsch,</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Ph.D.</span></p><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><br /></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">2)<span style="mso-spacerun: yes;"> </span>Treating AIDS and HIV Infection with
Methionine Compositions.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Continuation-in-part of above
patent.<span style="mso-spacerun: yes;"> </span>United States<span style="mso-spacerun: yes;"> </span>5,430,064<span style="mso-spacerun: yes;">
</span>Issued </span><st1:date day="4" month="7" year="1995"><span style="font-family: Garamond; font-size: 14.0pt;">July 4, 1995</span></st1:date><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;">
</span>2 inventors:<span style="mso-spacerun: yes;"> </span>Robert Bayless and
Gerald P. Hirsch, Ph.D.<o:p></o:p></span></p><p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"><br /></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">3)<span style="mso-spacerun: yes;"> </span>Treating Inflammatory Pain with
Methionine<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>United States<span style="mso-spacerun: yes;"> </span>5,053,429 Issued </span><st1:date day="1" month="10" year="1991"><span style="font-family: Garamond; font-size: 14.0pt;">Oct.
1, 1991</span></st1:date><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;"> </span>2 inventors:<span style="mso-spacerun: yes;">
</span>Robert Bayless<span style="mso-spacerun: yes;"> </span>and Gerald P.
Hirsch,<span style="mso-spacerun: yes;"> </span>Ph.D.<o:p></o:p></span></p><p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"><br /></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">4)<span style="mso-spacerun: yes;"> </span>Antioxidant Compositions and Methods
Ameliorating Inflammatory Symptoms of Respiratory Disease<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>United States 4,927,850<span style="mso-spacerun: yes;"> </span>Issued </span><st1:date day="22" month="5" year="1990"><span style="font-family: Garamond; font-size: 14.0pt;">May 22,
1990</span></st1:date><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></span><span style="font-family: Garamond; font-size: 14pt;">2
inventors:</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Robert Bayless and Gerald P.
Hirsch,</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Ph.D.</span></p><p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"><br /></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">5)<span style="mso-spacerun: yes;"> </span>Calcium Homeostasis Compositions and Methods
for Controlling Calcium Metabolism<span style="mso-spacerun: yes;"> </span>United
States 4,902,718 <span style="mso-spacerun: yes;"> </span>Issued </span><st1:date day="20" month="2" year="1990"><span style="font-family: Garamond; font-size: 14.0pt;">February
20, 1990</span></st1:date><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> 2</span></span><span style="font-family: Garamond; font-size: 14pt;"> inventors:</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Robert Bayless and Gerald. P. Hirsch, Ph.D.</span></p><p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"><br /></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">6)<span style="mso-spacerun: yes;"> </span>Methods for Inhibiting Inflammatory
Ischemic, Thrombotic and Cholesterolemic Disease Response with Methionine
Compounds<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>United States 5,084,482 Issued </span><st1:date day="28" month="1" year="1992"><span style="font-family: Garamond; font-size: 14.0pt;">January
28, 1992</span></st1:date><span style="font-family: Garamond; font-size: 14.0pt;"><span style="mso-spacerun: yes;"> </span>2
inventors:<span style="mso-spacerun: yes;"> </span>Robert Bayless and Gerald P. Hirsch,
Ph.D.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">REFERENCES<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">Earl Matthew<span style="mso-spacerun: yes;"> </span>M.D.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Paul Lebourgeois<span style="mso-spacerun: yes;"> </span>M.D.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b style="mso-bidi-font-weight: normal;"><span style="font-family: Garamond; font-size: 14.0pt;"><a href="mailto:earlmatthewmd@yahoo.com"><span style="font-weight: normal;">earlmatthewmd@yahoo.com</span></a><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><a href="mailto:Paul@Lebourgeois.org"><span style="font-weight: normal;">Paul@Lebourgeois.org</span></a> <o:p></o:p></span></b></p>Salchaterohttp://www.blogger.com/profile/08618324316165845094noreply@blogger.com0tag:blogger.com,1999:blog-7932883748144108610.post-60619815590162886942015-04-02T07:30:00.007-07:002023-04-16T13:03:41.633-07:00Antibiotic Executive Summary<div class="MsoNormal" style="text-indent: 0.5in;"><p class="MsoTitle" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> <o:p></o:p></span></p>
<p class="MsoTitle" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoTitle" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> ANTIBIOTIC EXECUTIVE SUMMARY<o:p></o:p></span></p>
<p class="MsoTitle" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">In 1985, my late business partner, Gerald Hirsch, Ph.D.
biochemist, and I developed a theory describing a hypothetical
antibiotic. We established The Lithox Corporation to exploit this new
technology. We spent four years trying to synthesize the molecule, but
were unsuccessful, and we closed The Lithox Corporation in 1989. <o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">
After 15 years working on the idea, I finally succeeded
through trial and error. My 74<sup>th</sup> attempt yielded the
correct synthetic method. Here is a summary of my work.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoTitle" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; text-indent: 0.5in;">A NEW
ANTIBIOTIC COMPOUND </span></p>
<p class="MsoTitle" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt; text-align: left; text-indent: 0.5in;">I have discovered a
new chemical entity with antibiotic properties that works by inhibiting the
production of protein in bacteria. This stops bacterial growth without
killing them. This compound should have low toxicity to humans because it does
not interfere with human protein synthesis, which differs from that of
bacteria.</span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-indent: .5in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Since protein synthesis in bacteria is carried on outside
of </span><st1:stockticker><span style="font-family: Garamond; font-size: 14pt;">DNA</span></st1:stockticker><span style="font-family: Garamond; font-size: 14pt;">, the compound does not target </span><st1:stockticker><span style="font-family: Garamond; font-size: 14pt;">DNA</span></st1:stockticker><span style="font-family: Garamond; font-size: 14pt;"> synthesis or
functions. This means that bacteria should not develop resistance to the
compound as they do with antibiotics that target </span><st1:stockticker><span style="font-family: Garamond; font-size: 14pt;">DNA</span></st1:stockticker><span style="font-family: Garamond; font-size: 14pt;">. This characteristic
is significant. Because of the lethal properties of many existing
antibiotics, bacteria have developed resistance. Antibiotic-resistant
bacteria, including the flesh-eating MRSA, are increasingly prevalent in
hospitals and doctor’s offices world-wide, posing significant risks to
patients. Although some current treatments exist for this problem, they
can be difficult to administer, toxic to humans, or have expired patent
protection. This new compound has the potential to solve these problems
and offer significant revenues to pharmaceutical companies.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">This antibacterial compound can be used for humans for
internal infections and external skin infections, veterinarian use—both in food
animals and pets—and agricultural use to treat bacterial infections in
plants. It can also be used as a topical spray, and in wound coverings to
prevent or treat bacterial infections, and many other uses where anti-bacterial
capability is desired.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-indent: .5in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">
The inventor, who already holds several patents, has developed a novel method
to create the molecule, the compound he created has not been described in the
scientific literature, and the antibacterial properties of the compound are
unanticipated in the literature. These factors make the compound novel and
useful, which is necessary for patentability.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> The
initial testing on bacteria, including MRSA, has been completed, and produced
positive results as expected. The next stage includes wider in vitro tests,
chemical characterization, and animal testing. Patent filings would
follow.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">
The market potential, considering the wide variety of uses, is huge. My goal is
to create an entity that subcontracts the necessary testing, files patents, and
licenses the patents to various companies who will then complete the testing
appropriate to their respective markets, and commercialize the compound.<o:p></o:p></span></p></div>
Salchaterohttp://www.blogger.com/profile/08618324316165845094noreply@blogger.com0tag:blogger.com,1999:blog-7932883748144108610.post-48246722846957202562015-04-02T07:29:00.046-07:002023-04-16T13:09:22.033-07:00Antibiotic Business Plan<!--[if !mso]>
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<![endif]--><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">BUSINESS PLAN FOR DEVELOPMENT AND
MARKETING </span></p><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> OF A NEW ANTIBIOTIC</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="margin-left: 1.5in; text-align: justify; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">THE PATENT IS THE PRODUCT<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; text-indent: 0.5in;">By Robert
Bayless, inventor.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Following positive
Phase III test results for both a new anti-fungal and a new antibiotic, Pfizer,
Inc. bought a small company, Vicuron Pharmaceuticals, for $1.9 billion in cash
in 2005. Pfizer could justify such a purchase premium because total worldwide
antibiotic sales in 2000 exceeded $25 billion. A single blockbuster drug can
generate $1 billion in sales in the first year, allowing large drug firms to
recoup their investment immediately.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Project Summary: This
project to create, patent, and market a patent describing a new antibiotic
requires a total investment of $5 million over five years to maximize future patent
yields. Identifying, testing, and preparing the patent should take four years,
followed by filing the patent and marketing it to drug firms in year five. When
a drug firm commits to a licensing deal, they typically pay upfront money, and
royalty payments in the range of 5% to 10% of total revenue continue for the
patent's life. Setting up a joint venture between a major drug firm and the
patent holder increases the potential for a higher return to the original
investors compared to a license or acquisition.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Background: In 1983,
Robert Bayless began researching new antibiotics to treat bacterial infections
with the late Dr. G.P. Hirsch, Ph.D. He and Dr. Hirsch established The Lithox
Corporation in 1985 to further refine this research. After four years of work,
they were unable to synthesize a stable product that could withstand the rigors
of synthesis, purification, and analysis. They filed and were granted six </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14pt;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt;"> patents disclosing
the use of an amino acid as an antioxidant to treat various ailments. In 2001,
while continuing his study alone, Bayless discovered a novel synthesis method
for a new antibiotic. After considerable research and work, he filed a series
of Disclosure Documents, culminating in the 2014 disclosure The
disclosed products need to be synthesized and identified using a variety of
standard analytical techniques, biological tests conducted both in vitro and in
animals, and patents filed describing such products and their uses.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Challenges:</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">The </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;"> pharmaceutical industry is facing
challenges. Worldwide, branded pharmaceutical sales are projected to exceed
$706 billion in 2012. However, about 9% of patents expire annually, resulting
in a loss of roughly $60 billion in protected revenues to the generic market
each year. For instance, in 1984, only 19% of </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;"> prescriptions were filled with
generics; by 2015, that number had risen to 88%. The generic market comprises
approximately $67 billion in sales each year, with profit margins that are
razor-thin compared to those of patent-protected drugs. Global animal
pharmaceutical sales average around $14 billion per year, with large volumes
but minuscule profits. Consequently, large drug firms actively seek patented
products for human use that will ensure a price-protected market for the
future.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Primary target markets for a new
antibiotic include:</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Internal use to treat bacterial
infections in humans, including respiratory infections.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">External use to treat bacterial
skin infections in humans.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Inhalation use to treat
bacterial lung infections in humans.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Internal use to treat bacterial
infections in food and non-food animals.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">External use to treat bacterial
skin infections in food and non-food animals.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Systemic use to treat bacterial
infections in food and non-food plants.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Topical sprays to treat
bacterial infestations in food and non-food plants.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Cleaning fluids and sprays to
disinfect surfaces.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Disinfection of foods and
liquids, including water and blood.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Use in wound coverings to
prevent and treat bacterial infections.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="display: none; font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN; mso-hide: all;">Top of
Form<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="display: none; font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN; mso-hide: all;">Top of
Form<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Market Strategy:</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Bayless proposes to
market patent-pending drugs to large pharmaceutical firms with the resources to
conduct clinical trials and finance the FDA regulatory process necessary to
sell drugs in the </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14pt;">United States</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt;">. However, large drug
firms refuse to sign Non-Disclosure Agreements in order to review new drug
entities in the pre-patent stage because of concerns that their ongoing
research may impinge on the new material. By designating the drugs as
patent-pending, the drug firms can review the material without such concerns.
Additionally, since it takes on average 12 years and costs $24 million to bring
a New Chemical Entity (NCE) to the preclinical/nonclinical patented stage,
large drug firms can skip a significant part of the time delay and uncertainty
of the drug discovery process (refer to Attachment "C" for an
in-depth discussion of drug discovery and development costs). The cost
difference between the $24 million incurred on average by large firms to
develop a patented drug in-house and the $5 million cost outlined by this
document constitutes the value-added available to investors in this plan.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Patents:</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Patents are legal
monopolies granted within the capitalist system that provide up to 20 years of
exclusive ownership for a given technological advance. European patents must be
filed before </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14pt;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt;"> patents issue to
protect European rights, so the timing of patent filing is of great importance.
Investors should consult patent counsel to fully understand the patent process.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"><br /></span></p><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;">Fund</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">ing Proposal:</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">To interest a major drug firm in
a licensing deal, the following steps must be accomplished (please refer to
Attachment “B” for the complete Research Plan proposal):</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Step I: Set up a corporate
entity to pursue the patent (please see Corporate Structure for details).</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Step II: Prepare and file a
provisional </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;"> patent. Although Bayless has
already written one, it requires review and editing by patent counsel before
filing.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Step III: Synthesize compounds,
identify chemicals, and conduct biological testing. Once the Provisional Patent
is filed, approach companies to subcontract the synthesis, analysis, and in
vitro and animal testing required to support a patent filing.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Step IV: File U.S. Patent
application(s) based on the results. Filing provides patent pending protection.
Filing foreign patents must occur before the </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;"> patent issues. Steps II and III
run concurrently.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Step V: Begin marketing the
patent(s) to major drug firms.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">TYPICAL PHARMACEUTICAL LICENSING
DEALS ANNOUNCED IN 2006:</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">GlaxoSmithKline has agreed to
purchase all outstanding shares of Praecis Pharmaceuticals for $54.8 million.
Praecis has an anticancer drug in development.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Genmab has entered into a
worldwide agreement with GlaxoSmithKline to commercialize a human monoclonal
antibody for the treatment of leukemia. Genmab received a license fee of $102
million, and GSK agreed to invest $357 million in Genmab. Additionally, Genmab
received tiered royalties on worldwide sales.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Exelixis has entered into a
worldwide agreement to develop cancer treatments with Bristol-Myers Squibb.
Exelixis received $60 million in cash, $20 million for each drug candidate
selected by BMS, and royalties on worldwide sales.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Altus Pharmaceuticals has
entered into an agreement with Genentech to commercialize their version of
human growth hormone. Genentech paid $15 million upfront and purchased $15
million of </span><st1:city><st1:place><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Altus</span></st1:place></st1:city><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">' stock. Commercialization
milestones trigger up to an additional $110 million in payments.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Kosan Biosciences has
established a worldwide license agreement with Pfizer for a drug to treat
gastrointestinal diseases. Kosan received $12.5 million upfront, and Pfizer
will initiate a Phase I trial. If commercialization is successful, Kosan will
receive $250 million, as well as royalties on worldwide sales.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">AstraZeneca paid a $20 million
milestone payment to Targacept following the successful completion of clinical
studies of a cognitive-enhancing drug.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">MedImmune signed an agreement
with Japan Tobacco with the intent to develop a monoclonal antibody to treat
lupus. JT received upfront payments, as well as royalties on marketed products.
MedImmune received exclusive development and marketing rights everywhere in the
world except </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN;">Japan</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;"> </span></p><p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">C</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">rucell has signed a
cross-licensing agreement with Merck, allowing Merck to use Crucell's
technology in the vaccine field. In exchange, Crucell will receive access to
Merck's large-scale vaccine manufacturing technology.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: 0pt;">Albany Molecular Research has
entered into a two-year collaboration with Bristol-Myers Squibb. This
collaboration includes upfront payments, research funding, and milestone
payments.</span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="display: none; font-family: Garamond; font-size: 14.0pt; letter-spacing: 0pt; mso-fareast-font-family: SimSun; mso-fareast-language: ZH-CN; mso-hide: all;">Top of
Form<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
Salchaterohttp://www.blogger.com/profile/08618324316165845094noreply@blogger.com0tag:blogger.com,1999:blog-7932883748144108610.post-32808693293179087572015-04-02T07:28:00.066-07:002023-04-16T13:17:39.319-07:00Attachment B: Research Plan<!--[if gte mso 9]><xml>
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</xml><![endif]--><p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span></p>
<p class="MsoNormal" style="margin-left: 1.5in; mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;">THE PATENT IS THE PRODUCT<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> RESEARCH </span><st1:stockticker><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;">PLAN</span></st1:stockticker><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> FOR PATENT
FILING</span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> U.S.
Patent law establishes a blueprint for research aimed at patenting a new
chemical compound with medicinal properties in humans. The compound must be novel, which means that
it must be chemically identified, and then a patent search, as well as a Chemical
Abstract search, must show that no similar compound has been synthesized and
characterized anywhere in the world in the last 150 years. The specific tests to positively identify a
given compound will vary according to the atomic structure of the compound, but
general categories of compounds require similar tests.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-indent: .25in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">A patentable compound must have demonstrable utility,
which in the case of medicinal compounds, has been defined by court ruling to
mean both in vitro tests and successful animal tests. An U.S. Appeals Court ruling has established
that reduction to practice for a medicinal compound occurs only after
successful completion of appropriate animal tests, so any patent filing
submitted without such data will fail on grounds of non-utility. Clinical
trials showing utility in humans are not necessary to obtain a valid </span><st1:country-region style="text-indent: 0.25in;"><st1:place><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;"> patent. </span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-indent: .25in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">There also exists the patent concept of broad versus
narrow patents.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">A broad patent is
granted to a novel group of compounds in which a new area of chemical entities with
novel properties has been discovered.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">A
narrow patent is granted where a new use for a known compound is sought.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">Broad patents have more commercial value than
narrow patents.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">With broad patents, the
rule is:</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">show three examples, and claim
the world.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">Therefore, a search for
closely related compounds with biological activity is mandatory if a broad
patent is desired. </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.25in;">Effectiveness against
a range of organisms allows broad claims of utility against entire classes of
organisms.</span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-indent: .25in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">With these considerations in mind, a sequential course
of action would include the following steps:</span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">Year One:</span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">Set up the corporate structure to
retain the rights to any patents filed by the corporate entity. </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">Retain a patent lawyer to review the
provisional patent as already written by Bayless.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">A prior art search and opinion as to the
patentability of the drug discovery is the first step.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">A provisional patent should then be filed, as
revised by the attorney.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">Provisional
patents are used a place-holders.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">If the
actual patent filing goes beyond the provisional patent in scope, the Patent
Office will disallow the broader claims, so the provisional patent should be as
broad as possible.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">Provisional patents
are good for one year.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">If the actual
patent is not filed within the one-year period, a second or third provisional
patent can be filed, but the priority filing date of the first or second
provisional patent is lost.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;"> </span></p>
<p class="MsoNormal" style="margin-left: .5in; mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-indent: .5in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: 0.5in;">Cost: $50,000.</span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span></p>
<p class="MsoNormal" style="margin-left: .25in; mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;">SYNTHESIS OF COMPOUNDS:
<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: 34.8pt; mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;">Once the provisional patent is filed, a preclinical drug
discovery company that specializes in synthesis and testing of compounds will
be located and hired (See Southern Research Institute at end for example). An NDA should be signed by the companies
selected, but the provisional patent does not have to be shared with them until
after a deal is signed. Once the legal requirements
are in place, synthesis of active ingredients, using both Method One and Method
Seventy-Four, will be conducted with the original compound as well as its analogs,
as selected by Bayless. Following
synthesis, precipitation and/or freeze-drying, the purification of active
ingredients will occur. Synthesis of
compounds will be an on-going process that may require two to four years to
complete. Research is not a linear
process, but a series of hop-scotch steps forward and back and sideways, making
it hard to forecast how long is long enough. <o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: 34.8pt; mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">Cost:</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">
</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">$950,000.</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Year
Two:</span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Biological testing should begin.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">As compounds are synthesized, they should be
tested in vitro against a range of micro-organisms in order to select
metabolically active compounds for further review.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">A biological testing
lab will have to be selected and hired to conduct such tests.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">(See Accugen Labs for example at end)</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Here again, the extent of in vitro testing
necessary to evaluate synthesized compounds is difficult to forecast at this
time.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">The obvious endpoint is when
sufficient testing is completed to support a broad patent.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">The patent attorney should have input here.</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">IN
VITRO BIOLOGICAL TESTS:</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt; text-indent: -0.25in;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><span dir="LTR" style="text-indent: -0.25in;"><span style="font-family: Garamond; font-size: 14.0pt;">Tests of synthesized compounds should be run to identify
which of</span></span></p>
<p class="MsoNormal" style="margin-left: .75in;"><span style="font-family: Garamond; font-size: 14.0pt;">them possess inhibitory properties. Growth Inhibition Curves in liquid media<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: .75in;"><span style="font-family: Garamond; font-size: 14.0pt;">against a range of bacteria will accomplish this task.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt; text-indent: -0.25in;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><span dir="LTR" style="text-indent: -0.25in;"><span style="font-family: Garamond; font-size: 14.0pt;">Toxicity screens of active compounds in yeast will reveal
toxicity profiles and </span></span></p><p class="MsoNormal"><span dir="LTR" style="text-indent: -0.25in;"><span style="font-family: Garamond; font-size: 14.0pt;"> provide the Therapeutic Index on each candidate and allow
the selection those </span></span></p><p class="MsoNormal"><span dir="LTR" style="text-indent: -0.25in;"><span style="font-family: Garamond; font-size: 14.0pt;"> that are both active and non-toxic.</span></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal" style="margin-left: .75in; mso-list: l0 level1 lfo2; tab-stops: list .75in; text-indent: -.25in;"><!--[if !supportLists]--><span style="font-family: Garamond; font-size: 14.0pt; mso-bidi-font-family: Garamond; mso-fareast-font-family: Garamond;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"><span style="font-family: Garamond; font-size: 14.0pt;">Additional tests, including Minimum Inhibitory
Concentration determinations as well </span></span><span style="font-family: Garamond; font-size: 14pt;">as Growth Inhibition Curves in liquid media, and Zone of
Inhibition tests using solid media against a range of pathogenic Gram-positive
and Gram-negative organisms, both aerobic and non-aerobic, will establish which
compounds are worth the time and expense of characterization.</span></p>
<p class="MsoNormal" style="margin-left: .75in;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Cost:</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">$1,000,000.</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Year
Three:</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Compounds which have in vitro activity
against bacteria, and a satisfactory Therapeutic Index, will then be
characterized by an Analytical Chemist.</span><span style="font-family: Garamond; font-size: 14pt;">
</span><span style="font-family: Garamond; font-size: 14pt;">The same lab that does the synthesis may perform the characterization,
or a different lab may be selected.</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-indent: .25in; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;">ANALYTICAL METHODS:<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">Once the
activity and toxicity profiles of active compounds have been established,
chemical characterization should occur.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">
</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">By following this sequence, only active compounds go through the expense
of lab identification.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">Following
identification, a Chemical Abstract search by the patent attorney will confirm
the novelty of the group of compounds.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">
</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">Typical tests for this group of compounds include:</span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; text-align: left; text-indent: -0.25in;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><span dir="LTR" style="text-align: left; text-indent: -0.25in;"><span style="font-family: Garamond; font-size: 14.0pt;">Ultraviolet spectroscopy with water as solvent.</span></span></p>
<p class="MsoNormal" style="margin-left: .5in;"><span style="font-family: Garamond; font-size: 14pt; text-indent: -0.25in;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><span dir="LTR" style="text-indent: -0.25in;"><span style="font-family: Garamond; font-size: 14.0pt;">Paper chromatography,</span></span></p>
<p class="MsoNormal" style="margin-left: .5in;"><span style="font-family: Garamond; font-size: 14.0pt;"> using the ascending
technique with propanol-ethanol-water <span style="letter-spacing: -.15pt;">(40:40:20).</span></span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-align: justify; text-indent: 0.5in;"> </span></p>
<p class="MsoNormal" style="margin-left: .75in; mso-list: l2 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><!--[if !supportLists]--><span style="font-family: Garamond; font-size: 14.0pt; mso-bidi-font-family: Garamond; mso-fareast-font-family: Garamond;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"><span style="font-family: Garamond; font-size: 14.0pt;">Infrared spectroscopy to determine the molecular
composition of the compounds.</span></span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="margin-left: .75in; mso-list: l2 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><!--[if !supportLists]--><span style="font-family: Garamond; font-size: 14.0pt; mso-bidi-font-family: Garamond; mso-fareast-font-family: Garamond;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"><span style="font-family: Garamond; font-size: 14.0pt;">Nuclear magnetic resonance to determine the structure of
the compounds.</span></span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="text-indent: .5in;"><span style="font-family: Garamond; font-size: 14.0pt;">5. Mass spectrometry for detection and
identification of components.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Cost:</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">$1,000,000.</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Year
Four:</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Once
the compounds have been synthesized, tested in vitro, and characterized, they
should be tested in animals to provide evidenced for utility.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">An animal testing facility will have to be
located to conduct such testing. (See Idexx BioResearch for example at end).</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal" style="margin-left: .25in;"><span style="font-family: Garamond; font-size: 14.0pt;">ANIMAL TESTING:<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: .25in;"><span style="font-family: Garamond; font-size: 14pt;">Animal models for human disease exist, and appropriate
animals should be selected to demonstrate the ability of the compounds to
prevent death from pathogenic bacteria. Typically, animal testing first
involves establishing dosing levels, and then challenging the animal with
pathogenic bacteria while providing the drug to see if the animal
survives.</span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="margin-left: .25in;"><span style="font-family: Garamond; font-size: 14pt;">Therefore:</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">1. </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Determine maximum tolerated oral dose in the mouse
and rabbit.</span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="margin-left: .75in; mso-list: l1 level1 lfo3; tab-stops: list .75in; text-indent: -.25in;"><!--[if !supportLists]--><span style="font-family: Garamond; font-size: 14.0pt; mso-bidi-font-family: Garamond; mso-fareast-font-family: Garamond;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"><span style="font-family: Garamond; font-size: 14.0pt;">Perform Staphylococcus aureus (</span></span><st1:stockticker><span style="font-family: Garamond; font-size: 14.0pt;">MRSA</span></st1:stockticker><span style="font-family: Garamond; font-size: 14.0pt;">) and Escherichia coli (diarrhea)
challenge test in mouse and rabbit, and Francisella tularensis (Tularemia) and
Pasteurella mutocida (cholera) tests in rabbits. Dogs, cats, and pigs are also candidates for
testing.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;">ADDITIONAL IN VITRO TESTS:<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">3.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">Inhibition
screening on at least three normal human cell lines to provide a </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;">Therapeutic Index
for human cells.</span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> 4. Inhibition screening on lung, breast, and
prostate human tumor cell lines.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> </span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt; text-indent: -0.25in;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-size: 7pt; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span dir="LTR" style="text-indent: -0.25in;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;">Inhibition
tests on at least three species of protists in liquid media.</span></span><span style="font-family: Garamond; font-size: 14pt; letter-spacing: -0.15pt;"> </span></p>
<p class="MsoNormal" style="mso-hyphenate: none; mso-layout-grid-align: none; punctuation-wrap: simple; tab-stops: 381.0pt; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14.0pt; letter-spacing: -.15pt;"> 6.
Inhibition tests on Canine Distemper, Measles, and Ebola viruses in
vitro.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Cost:</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">$1,000,000.</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Year Five:</span></p>
<p class="MsoNormal" style="margin-left: .25in;"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Patent Filing.</span></p>
<p class="MsoNormal" style="margin-left: 15.0pt;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Once the various synthesis, purification, analytical and biological
techniques are completed, </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14.0pt;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt;"> patent(s) must be filed. Estimated time to completion from the
original filing: three years. PCT patent(s)
must be filed within one year of a </span><st1:country-region><st1:place><span style="font-family: Garamond; font-size: 14.0pt;">U.S.</span></st1:place></st1:country-region><span style="font-family: Garamond; font-size: 14pt;"> patent application.</span></p>
<p class="MsoNormal" style="margin-left: 33.0pt;"><span style="font-family: Garamond; font-size: 14pt;">Once the patent is filed, potential licensing partners
can be contacted.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">A marketing manager
should be hired to lead this effort.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Only
major pharmaceutical companies have the financial means to carry a drug
candidate through the FDA process to market.</span><span style="font-family: Garamond; font-size: 14pt;">
</span><span style="font-family: Garamond; font-size: 14pt;">Up-front money is usually paid at signing, with royalty payments as
negotiated.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Joint ventures with major
pharmaceutical companies should be investigated as a possible alternative.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Out-right sale is also possible, although
licensing and royalties generally result in more money to investors over
time.</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p class="MsoNormal" style="margin-left: 33.0pt;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">Cost:</span><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;">$1,000,000.</span></p>
<p class="MsoNormal" style="margin-left: 33.0pt;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal" style="margin-left: 33.0pt;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal" style="margin-left: 105.0pt; text-indent: 3.0pt;"><span style="font-family: Garamond; font-size: 14.0pt;"> SOUTHERN RESEARCH INSTITUTE<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: 33.0pt;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal"><st1:place><st1:city><b><span style="font-family: Garamond; font-size: 14.0pt;">BIRMINGHAM</span></b></st1:city><b><span style="font-family: Garamond; font-size: 14.0pt;">, </span></b><st1:state><b><span style="font-family: Garamond; font-size: 14.0pt;">Ala.</span></b></st1:state></st1:place><b><span style="font-family: Garamond; font-size: 14.0pt;"> —Southern Research</span></b><span style="font-family: Garamond; font-size: 14.0pt;"> Institute conducts both contract
research and basic research for clients, providing preclinical drug discovery,
development, and clinical trial support services in cancer, infectious
diseases, and CNS/neurological disease to pharmaceutical and biotechnology
companies. Scientists conduct translational science to invent small molecules
and advance them from the design stage to the clinic. Services available
include medicinal chemistry, molecular biology, biochemistry, high-throughput
screening and a full set of in-house GLP development services including
toxicology, ADME/PK, animal models, formulations, and bioanalytical services. <o:p></o:p></span></p>
<p class="MsoNormal"><b><span style="font-family: Garamond; font-size: 14.0pt;">About Southern Research</span></b><span style="font-family: Garamond; font-size: 14.0pt;"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">Southern Research Institute is a
not-for-profit 501(c)(3) scientific research organization founded in 1941 that
conducts preclinical drug discovery and development, advanced engineering
research in materials, systems development, and environment and energy
research. More than 550 scientific and engineering team members support clients
and partners in the pharmaceutical, biotechnology, defense, aerospace,
environmental and energy industries. Southern Research is headquartered in </span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt;">Birmingham</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt;">Ala.</span></st1:state></st1:place><span style="font-family: Garamond; font-size: 14.0pt;">, with facilities in </span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt;">Wilsonville</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt;">Ala.</span></st1:state></st1:place><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt;">Frederick</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt;">Md.</span></st1:state></st1:place><span style="font-family: Garamond; font-size: 14.0pt;">, and </span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt;">Durham</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt;">NC</span></st1:state></st1:place><span style="font-family: Garamond; font-size: 14.0pt;"> and offices in </span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt;">Huntsville</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt;">Ala.</span></st1:state></st1:place><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt;">New Orleans</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt;">La.</span></st1:state></st1:place><span style="font-family: Garamond; font-size: 14.0pt;">, and </span><st1:place><st1:city><span style="font-family: Garamond; font-size: 14.0pt;">Washington</span></st1:city><span style="font-family: Garamond; font-size: 14.0pt;">, </span><st1:state><span style="font-family: Garamond; font-size: 14.0pt;">DC</span></st1:state></st1:place><span style="font-family: Garamond; font-size: 14.0pt;">. <o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: 2.0in; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-indent: .5in;"><span style="font-family: Garamond; font-size: 14.0pt;">ACCUGEN </span><st1:stockticker><span style="font-family: Garamond; font-size: 14.0pt;">LABS</span></st1:stockticker><span style="font-family: Garamond; font-size: 14.0pt;"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">Accugen is a FDA registered,
independent contract microbiology laboratory. We offer full <b>microbiological
testing</b> and analyze products from a wide variety of industries. Our
microbiological testing laboratory is comprised of a highly experienced team of
microbiologists who are experts in testing </span><st1:stockticker><span style="font-family: Garamond; font-size: 14.0pt;">ASTM</span></st1:stockticker><span style="font-family: Garamond; font-size: 14.0pt;">, AOAC, AATCC, FDA, EPA, USDA,
USP, CTFA, JIS, ISO and other methods of analysis. Our competent professionals
have decades of experience in routine microbiological analysis, special
microbiology, research microbiology, and a variety of other microbiological
testing. We are considered leading authorities in microbial testing. Accugen
has provided impeccable microbiological services to pharmaceutical,
disinfectant, cosmetic, food, personal care, household, medical device,
antimicrobial, paint, paper, plastic, textile and other miscellaneous
industries. At Accugen, we understand the challenges presented by a changing
market place and our goal is to maintain the cost effective and highest quality
microbiological testing services.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-left: 2.0in; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-indent: .5in;"><span style="font-family: Garamond; font-size: 14.0pt;"> </span></p>
<p class="MsoNormal" style="margin-left: 2.0in; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-indent: .5in;"><span style="font-family: Garamond; font-size: 14.0pt;">IDEXX BIORESEARCH<o:p></o:p></span></p>
<h1><span style="font-family: Garamond; font-size: 14.0pt;">Preclinical and
Veterinary Clinical Testing<o:p></o:p></span></h1>
<ul type="disc">
<li class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">High-capacity pathology/lab services facility<o:p></o:p></span></li>
<li class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">Experienced clinical and anatomic pathology services<o:p></o:p></span></li>
<li class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">Dedicated research support team<o:p></o:p></span></li>
<li class="MsoNormal"><span style="font-family: Garamond; font-size: 14.0pt;">Reliable turnaround times<o:p></o:p></span></li>
</ul>
<p><span style="font-family: Garamond; font-size: 14.0pt;"> Researchers in the
top pharmaceutical organizations, biotechnology companies, and academic
institutions trust IDEXX Bioresearch to deliver the highest caliber of
out-sourced lab results. Consider how we can bring your studies to a successful
conclusion. <o:p></o:p></span></p>
<ul type="disc">
<li class="MsoNormal"><span class="bold"><span style="font-family: Garamond; font-size: 14.0pt;">Complete range of testing
options—</span></span><span style="font-family: Garamond; font-size: 14.0pt;">One-stop,
accurate, reliable testing and consultation—Biochemistry, hematology,
immunology, microbiology, molecular biology, histology and anatomic
pathology using rigorously validated, state-of-the-art analyzers and
methodologies.<o:p></o:p></span></li>
<li class="MsoNormal"><span class="bold"><span style="font-family: Garamond; font-size: 14.0pt;">Certified technical staff—</span></span><span style="font-family: Garamond; font-size: 14.0pt;">A complete staff of
board-certified veterinary pathologists provides diagnostic reports and
study consultation. Experienced histology and clinical lab technicians, as
well as certified medical technologists experienced in comparative
clinical pathology.<o:p></o:p></span></li>
<li class="MsoNormal"><span class="bold"><span style="font-family: Garamond; font-size: 14.0pt;">Dedicated research support
team—</span></span><span style="font-family: Garamond; font-size: 14.0pt;">Consult
with our pathologists and qualified research support team to plan,
schedule, receive, monitor and deliver accurate results on time for your
studies.<o:p></o:p></span></li>
</ul><ul type="disc">
</ul>
Salchaterohttp://www.blogger.com/profile/08618324316165845094noreply@blogger.com0tag:blogger.com,1999:blog-7932883748144108610.post-39652033491446544992015-04-02T07:25:00.009-07:002023-04-16T13:19:42.567-07:00Corporate Structure<!--[if gte mso 9]><xml>
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</xml><![endif]--><p class="MsoNormal" style="margin-left: 1.0in; text-indent: .5in;"><span style="font-family: Garamond; font-size: 14pt; text-indent: 0.5in;"> </span><span style="font-family: Garamond; font-size: 14pt; text-indent: 0.5in;">FIRST MONEY IS LIKE YEAST</span></p>
<p class="MsoNormal"><span style="font-family: Garamond; font-size: 14pt;">I bring $25 million in research value to the table; I need $5 million and
five years to file a broad patent. </span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;">First Step: Set up a corporation
with one hundred million shares of Class A voting stock, and one hundred million
shares of Class B non-voting stock.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;">I get 60 million shares of Class A stock, and
the original investors of $5 million split 20 million shares of Class A stock
in proportion to their investment. <o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;">20 million shares of Class A stock, and all
of the Class B stock, remain in the corporation. <o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;">Original investors of $5 million get 80% of after-tax
licensing, royalty, or out-right sale revenue, proportionally divided, until
they receive 10x their investment value back. I receive 10 % of after-tax
licensing, royalty, or out-right sale revenue, until the original investors
receive 10x their investment back, with 10% remaining in the corporation.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;">After original investors earn their 10x back,
they then participate in subsequent after-tax licensing, royalty, or out-right
sale revenues at a 20% rate, proportionally divided. <o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in;"><span style="font-family: Garamond; font-size: 14pt;">Once the original investors earn their 10x
back, I receive 60% of any after tax licensing, royalty or out-right sale
revenue, and the rest stays in the corporation for use by the corporation
and/or distribution to Class B stockholders. Any subsequent stock
sale after the opening round involves Class B stock.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">After
setting up the corporate structure, the core people necessary to carry out the
required tasks must be assembled. These people include:<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Two
salaried people. Myself as CEO of the corporation, and a second
person with an administrative role to handle the office work. Office
space would be rented monthly. All other work would be
sub-contracted out on a fee-for-service basis. See Research Plan for more
information on out-sourcing of research. <o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">A
CPA firm to handle the money and bookkeeping. All investor funds
would go into an escrow account under the control of the CPA, who would
disperse the funds as needed by the CEO. This firm must be selected.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">A
pharmaceutical patent attorney. This person must be recruited. <o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">Business
and contract law attorney to provide counsel on general business
matters. This person needs to be recruited.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">A
marketing guru to supervise the marketing of the patent to pharmaceutical
candidates. This person or firm must also be selected.<o:p></o:p></span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;"> </span></p>
<p style="margin-bottom: .0001pt; margin: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: Garamond; font-size: 14pt;">I
also intend to form an Advisory Board to provide seasoned advice in a
structured environment. Advisors would be included as the project
proceeds. Attendees to Advisory Board meetings would receive
financial compensation for attending meetings and providing their expertise.<o:p></o:p></span></p>
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