Resonance Contracted by Major Global Pharma
Released
Released
Announcement PDF
ASX Announcement – 18 August 2023
RESONANCE CONTRACTED BY MAJOR GLOBAL PHARMA COMPANY FOR CLINICAL
DRUG TRIAL WORTH $6.33 MILLION OVER 18 MONTHS
Resonance Health Ltd (ASX: RHT) (Resonance or the Company) advises that it has been contracted by Sun
Pharmaceutical Industries Limited, an international, publicly listed pharmaceutical company with global
operations (Customer) to provide clinical research organisation (CRO), laboratory analysis, and imaging
services (collectively, Services), for their clinical trial in Australia of a new drug compound (Clinical Trial).
New Clinical Trial
The newly executed clinical trial agreement (Agreement) is worth an estimated AUD $6.33 million in revenue
to the Resonance group over the next ~18 months, with the first payments of AUD $1.055 million due within
30 days of Agreement execution. Resonance, through its wholly owned subsidiary, CRO Services Pty Ltd (CRO
Services), will serve as CRO and Local Sponsor for the Customer and will engage and make payment to the
institutions, trial sites, and the vendors needed to conduct the Clinical Trial.
Whilst the Company will receive the first payment within 30 days of Agreement execution, provision of the
Services under the Agreement (and the remaining payments) are subject to (among other things) receipt of
regulatory approvals to commence the Clinical Trial including human reseach ethics committee approval
(Regulatory Approvals).
Resonance will provide its imaging analysis services at various timepoints throughout the Clinical Trial along
with exploratory laboratory biomarker assessment services, from the Company’s new laboratory in Bentley
Tech Park, Western Australia. Resonance, in consultation with the Customer, has identified several trial sites
and investigators in Western Australia, and the Company expects patient recruitment for the Clinical Trial
could commence in late 2023, subject to obtaining Regulatory Approvals.
This contract win highlights Resonance’s strategy of providing its technology and services to the burgeoning
and highly technical global pharma and clinical trials markets, as envisaged by its launch of the Resonance
Clinical initiative in October 2022 (see ASX release, 25 October 2022).
The material commercial terms of the Agreement are summarised at Annex A.
Resonance Health CEO, Mr Andrew Harrison commented:
“The Agreement is a direct outcome of the Resonance Clinical initiative announced in October 2022 and I
acknowledge the enormous amount of work performed over the past couple of years to position the Company
and enable the successful procurement of a pharma services agreement of this magnitude. In revenue and
range of services terms, this is a very material agreement for the Company.”
Resonance and CRO Services Director, Mr Mitchell Wells commented:
“The Resonance Clinical initiative is about capability expansion and growth acceleration, targeted specifically
at the prolific global clinical trial marketplace, and leveraging Australia’s attractiveness as a place to perform
Resonance Health Ltd ABN: 96 006 762 492
141 Burswood Road, Burswood, WA 6100, AUSTRALIA
Postal: PO Box 71, Burswood, WA 6100, AUSTRALIA
www.resonancehealth.com
T + 61 8 9286 5300
info@resonancehealth.com
clinical trials for global pharma companies. I thank our shareholders for their support while we have made
the necessary changes and investment in our business to position ourselves for these growth opportunities.
This Clinical Trial is hopefully the first of more to follow with this important customer. In addition to this being
good for Resonance, this is good for Australia and Western Australia, and it speaks to our ability to draw some
of the world’s largest pharma companies to Australia for trialling new drug innovations. I look forward to
working with our CEO, our talented personnel, and with our customer on the Clinical Trial.”
This announcement has been authorised for release in accordance with the delegated authority of the Board
of Directors of Resonance Health Ltd. For further information please contact:
Andrew Harrison – Chief Executive Officer
E: andrewh@resonancehealth.com
P: +61 (0)8 9286 5300
Mitchell Wells – Director
E: mitchellw@resonancehealth.com
P: +61 (0)8 9286 5300
About Resonance Health
Resonance Health is an Australian healthcare technology and services company. The Company’s services are
used globally by clinicians in the management of human diseases and by pharmaceutical and therapeutic
companies in their clinical trials. Resonance Health has gained endorsement by leading physicians worldwide
for providing high quality quantitative assessments essential in managing diseases and drug development.
Resonance Health’s dedication to scientific rigour and quality has enabled it to achieve regulatory clearances
for a range of Software-as-Medical Devices (SaMDs) in the USA, Europe, UK, and Australia, and to proudly
carry ISO 13485 certification for the design and manufacture of medical devices. Regulatory cleared SaMD
products, some of which incorporate Artificial Intelligence (AI), include:
§ FerriScan®, a core-lab product that provides an accurate assessment of liver iron concentration (LIC)
through non-invasive MRI-based technology, for use in the assessment of individuals with iron overload
conditions. Internationally recognised as the gold standard in LIC assessment.
§ FerriSmart®, an AI-trained, non-invasive MRI-based device for the automated real-time assessment of LIC
in patients, calibrated against the global gold standard, FerriScan®.
§ HepaFat-Scan®, an MRI-based solution which provides a reliable non-invasive assessment of liver-fat in
liver tissue for use in the assessment of individuals with confirmed or suspected fatty-liver-disease.
§ HepaFat-AI®, an AI-trained, non-invasive device for the automated real-time multi-metric assessment of
liver-fat in patients, for the assessment of individuals with confirmed or suspected fatty liver disease.
§ LiverSmart®, an AI-trained, non-invasive MRI-based multi-parametric device combining FerriSmart® and
HepaFat-AI® into a consolidated report providing accurate assessment of LIC and liver fat.
§ CardiacT2*, the most widely accepted MRI method for assessing heart iron loading. Resonance Health
offers a dual analysis of FerriScan® and CardiacT2*. CardiacT2* is TGA and CE Marking regulatory cleared.
The Company has a development pipeline of additional medical imaging analysis products and services,
including the MRI Liver Fibrosis Project, aimed at accurately assessing the presence and progression of liver
fibrosis utilising non-invasive MRI analysis.
Stakeholders, including clinicians, patients, and shareholders, are encouraged to register their interest at
www.resonancehealth.com and to follow Resonance Health on Facebook, LinkedIn, and Twitter.
Page 2
Annex A
MATERIAL TERMS OF AGREEMENT
Term
Summary
1. Purpose
CRO Services has been appointed by the Customer as CRO and Australian local
sponsor to arrange and manage the Clinical Trial.
2. Key services
CRO Services will facilitate the Clincial Trial in Australia through engagement with
institutions (who will be responsible for the conduct of the Clinical Trial, through
Principal Investigators), regulators (including the Commonwealth Therapeutic
Goods Administration (TGA)), and Clinical Trial sites.
3. Conditions
precedent
Commencement of the Clinical Trial is subject to the Regulatory Approvals and
CRO Services executing standard-form Clinical Trial Agreements with each of the
institutions and Clinical Trial sites, and to theprocurement of requisite insurance
coverage by the Cusomter and CRO Services.
4. Payment
The total sum payable by the Customer to CRO Services is AU$6.33 million,
assuming the Clinical Trial runs its full expected duration. As local sponsor, CRO
Services will make payment to the institutions and other vendors for the Clinical
Trial. The Customer will pay the contract sum in 11 staged payments commencing
with 15% payable on signing of the Agreementand the final 10% on delivery of the
final Clinical Trial report. If the Clinical Trial is terminated for any reason, only
those costs incurred up until the date of termination, are payable.
5. Term and
Termination
The Agreement commences on its signing and will terminate in these scenarios:
1. When the Customer makes its final payment to CRO Services.
2. With 30 days’ prior written notice by a party; in the event of breach of the
Agreement or the Protocol by the other party which remains unremedied
within 30 days of written notice specifying the breach; orwhere the other
party is insolvent or subject to external administration or receivership.
3. Immediately, where a party believes that continuing the Clinical Trial poses an
unacceptable risk to any of the Clinical Trial participants.
4. By the Customer without cause, with 90 days’ notice (in which case, the
Customer will pay CRO Services for services performed up to termination).
6. Intellectual
property
All intellectual property in the Study vests in the Customer.
7. Assignment
and
subcontracting
The Agreement can be assigned or novated by either party with the other party’s
consent. CRO Services may subcontract any of its obligations with the Customer’s
prior consent, but remains responsible for all subcontracted obligations.
8. Governing law
The laws of Western Australia.
9. Other
The Agreement includes other terms that are standard for clinical trials performed
in Australia, consistent with the standard-form used for Australian clinical trials.
Page 3
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