<SEC-DOCUMENT>0001654954-20-010745.txt : 20201002
<SEC-HEADER>0001654954-20-010745.hdr.sgml : 20201002
<ACCEPTANCE-DATETIME>20201002062818
ACCESSION NUMBER:		0001654954-20-010745
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20201002
FILED AS OF DATE:		20201002
DATE AS OF CHANGE:		20201002

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		201218028

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a9316a.htm
<DESCRIPTION>FARXIGA GRANTED US BTD IN CHRONIC KIDNEY DISEASE
<TEXT>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Farxiga
granted US BTD in chronic kidney disease</font></div>
</div>
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&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0;&#xA0; <font style="color: #000000; font-family: Times New Roman; font-size: 13px">2
October 2020 07:00 BST</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Farxiga&#xA0;</font><font style="color: #000000">granted
Breakthrough Therapy Designation</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; color: #000000">
in US for</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000">chronic kidney
disease</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Designation follows DAPA-CKD Phase III trial results in which
Farxiga demonstrated unprecedented reduction in the risk of kidney
failure and cardiovascular or renal death in patients with chronic
kidney disease</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;(dapagliflozin) has been granted
Breakthrough Therapy Designation (BTD) in the US for patients with
chronic kidney disease (CKD), with and without type-2 diabetes
(T2D).</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
CKD is a serious, progressive condition defined by decreased kidney
function and is often associated with an increased risk of heart
disease or stroke.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2,3</font><font style="color: #000000">&#xA0;In
the US, 37 million people are estimated to have
CKD.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The Food and Drug Administration (FDA)'s BTD is designed to
accelerate the development and regulatory review of potential new
medicines that are intended to treat a serious condition and
address a significant unmet medical need. The new medicine needs to
have shown encouraging early clinical results that demonstrate
substantial improvement on a clinically significant endpoint over
available medicines.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&amp;D, said: "There is a serious, unmet need for better and
earlier treatment options for patients with chronic kidney disease.
Following the ground-breaking DAPA-CKD results, the Breakthrough
Therapy Designation is further testament
to&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">'s
potential to slow the progression of chronic kidney disease. We
look forward to working with the FDA to
make&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;available to patients as quickly as
possible."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The FDA granted BTD based on clinical evidence from the DAPA-CKD
trial. The&#xA0;</font><font style="text-decoration: underline; color: #0000FF">detailed
results</font><font style="color: #000000">&#xA0;presented in
August demonstrated that&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;on top of standard of care reduced the
composite measure of worsening of renal function&#xA0;or risk of
cardiovascular (CV) or renal death&#xA0;by 39% compared to placebo
(absolute risk reduction [ARR] = 5.3%, p&lt;0.0001) in patients
with CKD while also&#xA0;significantly reducing death from any
cause by 31% (ARR = 2.1%, p=0.0035) compared to
placebo.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In the US,&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;is indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with T2D and to
reduce the risk of hospitalisation for heart failure (hHF) in
patients with T2D and established CV disease or multiple CV risk
factors. In May,&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;was&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approved in the
US</font><font style="color: #000000">&#xA0;to reduce the risk of
CV death and hHF in adults with heart failure (HF) (NYHA class
II-IV) with reduced ejection fraction (HFrEF) with and without
T2D.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Chronic kidney disease</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
CKD is a serious, progressive condition defined by decreased kidney
function (shown by reduced estimated glomerular filtration rate
[eGFR] or markers of kidney damage, or both, for at least three
months)&#xA0;affecting nearly 700 million people worldwide, many of
them still undiagnosed.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3,6-8</font><font style="color: #000000">&#xA0;The
most common causes of CKD are diabetes, hypertension and
glomerulonephritis.&#xA0;</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</font><font style="color: #000000">&#xA0;CKD
is associated with significant patient morbidity and an increased
risk of CV events,</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font><font style="color: #000000">&#xA0;such
as HF and premature death.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;In
its most severe form, known as end-stage kidney disease (ESKD),
kidney damage and deterioration of kidney function have progressed
to the stage where dialysis or kidney transplantation are
required.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;The
majority of patients with CKD will die from CV causes before
reaching ESKD.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
DAPA-CKD</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
DAPA-CKD is an international, multi-centre, randomised,
double-blinded trial in 4,304 patients designed to evaluate the
efficacy of&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;10mg, compared with placebo, in patients
with CKD Stages 2-4 and elevated urinary albumin excretion, with
and without T2D.&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;is given once daily in addition to standard
of care. The primary composite endpoint is worsening of renal
function or risk of death (defined as a composite of an eGFR
decline &#x2265;50%, onset of ESKD and death from CV or renal
cause). The secondary endpoints included the time to first
occurrence of the renal composite (sustained &#x2265;50% eGFR
decline, ESKD and renal death), the composite of CV death or hHF,
and death from any cause. The trial was conducted in 21
countries&#xA0;and&#xA0;detailed results
were&#xA0;</font><font style="text-decoration: underline; color: #0000FF">announced in August
2020</font><font style="color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Farxiga</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Farxiga</font><font style="color: #000000">&#xA0;(dapagliflozin) is
a first-in-class, oral, once-daily sodium-glucose co-transporter-2
inhibitor indicated in adults for the treatment of insufficiently
controlled T2D as both monotherapy and as part of combination
therapy as an adjunct to diet and exercise to improve glycaemic
control, with the additional benefits of weight loss and
blood-pressure reduction. In the DECLARE CV outcomes trial in
adults with T2D,&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;reduced the risk of the composite endpoint
of hHF or CV death versus placebo, when added to standard of
care.</font></font></div>
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Farxiga</font><font style="color: #000000">&#xA0;is currently being
tested for patients with HF in the DELIVER (HF with preserved
ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF)
trials.&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;will also be tested in patients without T2D
following an acute myocardial infarction (MI) or heart attack in
the DAPA-MI trial - a first of its kind, indication-seeking
registry-based randomised controlled
trial.&#xA0;</font><font style="font-style: italic; color: #000000">Farxiga</font><font style="color: #000000">&#xA0;has
a robust programme of clinical trials that includes more than 35
completed and ongoing Phase IIb/III trials in more than 35,000
patients, as well as more than 2.5 million patient-years'
experience.</font></font></div>
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AstraZeneca in CVRM</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Cardiovascular, Renal and Metabolism (CVRM) together forms one of
AstraZeneca's three therapy areas and is a key growth driver for
the Company. By following the science to understand more clearly
the underlying links between the heart, kidneys and pancreas,
AstraZeneca is investing in a portfolio of medicines to protect
organs and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. The Company's ambition
is to modify or halt the natural course of CVRM diseases and
potentially regenerate organs and restore function, by continuing
to deliver transformative science that improves treatment practices
and cardiovascular health for millions of patients
worldwide.</font></div>
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AstraZeneca</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca&#xA0;(LSE/STO/Nasdaq: AZN)&#xA0;is a global,
science-led biopharmaceutical company that focuses on the
discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three therapy
areas - Oncology, Cardiovascular, Renal &amp; Metabolism, and
Respiratory &amp; Immunology. Based in Cambridge, UK, AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. Please
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="text-decoration: underline; color: #0000FF">.</font></font></div>
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For details on how to contact the Investor Relations Team, please
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For Media contacts, click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.</font></font></div>
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References</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">1.&#xA0;&#xA0; Centers for
Disease Control and Prevention. Chronic Kidney Disease in the
United States, 2019 [cited 01.05.20]. Available from
URL:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html</font><font style="color: #000000; font-size: 13px">.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">2.&#xA0;&#xA0;&#xA0;Segall L et al. Heart failure
in patients with chronic kidney disease: A systematic integrative
review.&#xA0;</font><font style="font-style: italic; color: #000000">Biomed Res
Int</font><font style="color: #000000">&#xA0;2014;
2014:937398&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">3.&#xA0;&#xA0; Bikbov B et al. Global, regional,
and national burden of chronic kidney disease, 1990-2017: A
systematic analysis for the Global Burden of Disease Study
2017.&#xA0;</font><font style="font-style: italic; color: #000000">The Lancet</font><font style="color: #000000">&#xA0;2020; 395(10225):709-33.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">4.&#xA0;&#xA0; U.S. Food and Drug
Administration. Frequently Asked Questions: Breakthrough Therapies
[cited 2020 Sep 28]. Available from: URL:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies</font><font style="color: #000000; font-size: 13px">&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">5.&#xA0;&#xA0;
Heerspink H. DAPA-CKD - Dapagliflozin in Patients with Chronic
Kidney Disease. presented at: ESC Congress 2020 - The Digital
Experience, 2020 August 29 - September 01</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">6.&#xA0;&#xA0;
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group.
KDIGO 2012 clinical practice guideline for the evaluation and
management of chronic kidney disease. Kidney International
Supplement 2013; (3):1-150.</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">7.&#xA0;&#xA0; Hirst JA et al. Prevalence of
chronic kidney disease in the community using data from OxRen: A UK
population-based cohort study.&#xA0;</font><font style="font-style: italic; color: #000000">Br J Gen
Pract</font><font style="color: #000000">&#xA0;2020;
70(693):e285-e293.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">8.&#xA0;&#xA0; National Kidney
Foundation. Kidney Disease: The Basics; 2020 [cited 2020 Sep 23].
Available from: URL:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">9.&#xA0;&#xA0; National Kidney
Foundation. Kidney Disease: Causes; 2015 [cited 2020 Sep 23].
Available from: URL:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.kidney.org/atoz/content/kidneydiscauses</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">10.&#xA0;&#xA0;Briasoulis A, Bakris GL. Chronic
Kidney Disease as a Coronary Artery Disease Risk
Equivalent.&#xA0;</font><font style="font-style: italic; color: #000000">Current Cardiology
Reports</font><font style="color: #000000">&#xA0;2013;
15(3):340</font></font></div>
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Adrian Kemp</font></div>
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Company Secretary</font></div>
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AstraZeneca PLC<br></font></div>
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SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">02</font>
<font style="font-weight: bold; font-size: 13px">October
2020</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
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