Country for PR: United States
Contributor: PR Newswire New York
Wednesday, September 08 2021 - 21:00
AsiaNet
The Valens Company Achieves Access to GMP Manufacturing in Australia & Expands International Footprint to Asia-Pacific through Exclusive Partnership with Epsilon Healthcare
KELOWNA, BC, Sept. 8, 2021 /PRNewswire-AsiaNet/ --

  -- Partnership will bring first GMP manufactured products to be sold through 
     Valens in both Australia and New Zealand
  -- Access to Epsilon's GMP facility in Australia to provide Valens with 
     future access to global markets including Latin America, Europe, UK 
     and Asia-Pacific

The Valens Company Inc. (TSX: VLNS) (OTCQX: VLNCF) (the "Company," "The Valens 
Company" or "Valens"), a leading manufacturer of cannabis products, today 
announced an exclusive partnership with Epsilon Healthcare Limited (ASX:EPN) 
(Epsilon), a diversified global healthcare and pharmaceuticals company, for 
access to Epsilon's Good Manufacturing Practices (GMP) facility in Australia 
for manufacturing products, furthering its international expansion to GMP 
markets in Latin America, Europe, UK and the Asia-Pacific regions. Products 
will be distributed through Valens' Australian Distribution Partner, Cannvalate 
PTY Ltd ("Cannvalate"), and will be the largest quantity of products provided 
to Cannvalate for distribution to date (collectively, the "Transaction"). The 
partnership is reflected in the terms of the Binding Heads of Agreement between 
the Epsilon, THC Pharma (the Epsilon's wholly owned subsidiary, and owner of 
the Southport Facility), Valens, and Valens Australia Pty Ltd (Valens' wholly 
owned subsidiary) (the "Agreement").

With this partnership The Valens Company continues its "revenue first, capital 
efficient" strategy of expanding internationally. As part of the Agreement with 
Epsilon and Cannvalate, Valens will be provided with access to Epsilon's GMP 
manufacturing capabilities at the Southport Facility (as defined below) located 
in Queensland, Australia, the largest cannabis manufacturing facility in the 
Southern Hemisphere, and the largest at domestic scale with complimentary 
Therapeutic Good Administration (TGA) and EU GMP capabilities. The partnership 
also marks the first GMP manufactured products to be sold through Valens in 
Australia, and provides Valens with the capability to deliver GMP-grade 
products to Latin America, Europe, UK and Asia-Pacific.

Key Transaction Details:

  - The Valens Company, a leading Canadian manufacturer of cannabis products, 
has entered into a long-term partnership with Epsilon, for exclusive access to 
the Epsilon's GMP Manufacturing Facility in Southport, Queensland Australia 
(the "Southport Facility')
  - Epsilon's Southport Facility is the largest cannabis extraction facility in 
the Southern Hemisphere with TGA and EU GMP capability
  - Valens to fund all operational and capital expenditure of the Southport 
Facility in return for preferential access for up to 85 percent of the 
operational capacity of the Southport Facility over the next five years, with 
an option to extend this arrangement for an additional six years
  - Valens to provide operational and management consultancy at the Southport 
Facility to bring their industry-leading intellectual property, technology, and 
team to the Southport Facility to take advantage of Epsilon's GMP Manufacturing 
capability
  - Marks first foray into EU GMP medicine production for Valens
  - The Agreement compliments its existing partnership with Cannvalate opening 
up GMP manufactured products to be sold through Cannvalate's distribution 
network First products manufactured under strategic alliance expected to be 
delivered in the coming weeks

Epsilon's wholly owned subsidiary, THC Pharma Pty Ltd (THC Pharma) operates a 
TGA and Office of Drug Control (ODC) licensed medicinal cannabis manufacturing 
facility with TGA and EU GMP capabilities in Southport, Queensland Australia. 
THC Pharma's GMP Southport facility is a 10,000 square foot purpose-built 
botanicals extraction facility capable of extraction of raw plant material and 
downstream purification and isolation processing. The facility consists of its 
own QC lab and grade D cleanroom space for the manufacture of oral dose format 
products. Epsilon also owns a number of medicinal cannabis assets, including 
the Tetra Health clinic, and the Medimar Platform – an end-to-end ecommerce 
solution for nutraceuticals and cannabis. Epsilon also operates a turn-key 
cannabis cultivation solutions provider based in Vancouver, Canada.

"With this partnership we have fulfilled our promise to achieve GMP 
manufacturing in 2021 and we have gained access to international cannabis 
markets through the 'Valens way,' utilizing an asset-light approach that allows 
us to export to GMP markets globally. We are excited to work with the largest 
and most advanced cannabis manufacturing facility in the Southern Hemisphere to 
distribute GMP products, and look forward to advancing our product distribution 
capabilities through our continued partnership with Cannvalate. We believe this 
strategic partnership is an efficient use of capital towards accessing GMP 
quality products and accelerates our timeline to market dramatically,"  said 
Tyler Robson, Chief Executive Officer and Chair of The Valens Company. "With 
the rapid unit volume growth coming out of our K2 facility that was built to 
GMP standards, we believe this agreement offers us the best of both worlds - 
access to GMP manufacturing without giving up on domestic revenue growth 
opportunities."

Jarrod White, Chief Executive Officer of Epsilon noted, "This year alone, 
Valens has grown exponentially not only across provinces and territories in 
Canada, but in the US as well, which is an excellent platform for the growth we 
see forthcoming in the international Medicinal Cannabis market generally. 
Epsilon's partnership with Valens as a leading manufacturer of cannabis 
products is complementary to our facility, being the largest TGA and EU GMP 
facility in the Southern Hemisphere. We are excited to be working with Valens 
during such a flourishing time in their corporate trajectory. Valens also shows 
a promising production throughput to scale up our GMP manufacturing capability. 
We look forward to furthering our partnership with Valens in the coming months 
as we accelerate the commercial production output from Epsilon's wholly owned 
facility."

Dr. Sud Agarwal, Chief Executive Officer of Cannvalate added, "Having worked 
closely with Valens for over a year, we have already noticed significant growth 
in their market share in the APAC market. Now, with access to a GMP facility 
via our partnership with Epsilon, we forecast a dramatic increase in demand 
both domestically and internationally. With New Zealand moving to a pureplay 
GMP market in October 2021 and the Australian Government indicating they will 
too in the very near future, we see this opportunity as building a significant 
competitive advantage for the Valens-Cannvalate partnership."

This initial production run is the first milestone of Valens' partnership with 
Epsilon. Valens anticipates that the partnership will see further expansion as 
it receives additional orders for GMP product globally.

Further details concerning the Transaction as set forth in Schedule 1 below.

At Valens, it's Personal.

About The Valens Company
The Valens Company is a leading manufacturer of cannabis products with a 
mission to bring the benefits of cannabis to the world. The Company provides 
proprietary cannabis processing services, in addition to best-in-class product 
development, manufacturing, and commercialization of cannabis consumer packaged 
goods. The Valens Company's high-quality products are formulated for the 
medical, health and wellness, and recreational consumer segments, and are 
offered across all cannabis product categories with a focus on quality and 
innovation. The Company also manufactures, distributes, and sells a wide range 
of CBD products in the United States through its subsidiary Green Roads, and 
distributes medicinal cannabis products to Australia through its subsidiary 
Valens Australia. In partnership with brand houses, consumer packaged goods 
companies and licensed cannabis producers around the globe, the Company 
continues to grow its diverse product portfolio in alignment with evolving 
cannabis consumer preferences in key markets. Through Valens Labs, the Company 
is setting the standard in cannabis testing and research and development with 
Canada's only ISO17025 accredited analytical services lab, named The Centre of 
Excellence in Plant-Based Science by partner and scientific world leader Thermo 
Fisher Scientific. Discover more on The Valens Company and its subsidiaries at 
http://www.thevalenscompany.com.

About Epsilon Healthcare Limited
Epsilon Healthcare (ASX:EPN) is an ASX listed diversified global healthcare and 
pharmaceuticals company. EPN owns a number of medicinal cannabis assets 
including the largest GMP cannabis manufacturing facility in the Southern 
Hemisphere, the Tetra Health clinic, and the Medimar Platform. EPN's 
manufacturing facility is a fully licensed and permitted Australian TGA and EU 
GMP bio-floral extraction facility with a range of approved GMP licensed 
products and formulations. EPN's facility is capable of product development, 
manufacturing, and commercialization of cannabis consumer packaged goods in 
addition to the manufacture of products and formulations for use in clinical 
trials to a TGA and EU GMP standard. EPN additionally operates a turn-key 
cannabis cultivation solutions provider based in Vancouver, Canada.

About Cannvalate
Cannvalate is Australia's largest business-to-business services company 
supporting both domestic and international Medicinal Cannabis companies fast 
track their growth into the Australian market. Their two key services include:

  - ACMA (Australian Cannabis Market Access) – Australia's largest network of 
medicinal cannabis prescribing clinics, consisting of more than 2,400 referring 
physicians and 600 affiliated pharmacies spanning all states of Australia. 
Cannvalate prescriptions currently account for almost 50% of the Australian 
market, which is now the fastest growing pure-play medical market in the world.
  - Medicinal Cannabis Research Collaboration (MCRC) – The world's only 
cannabis-specialised, Clinical Research Organisation (CRO) providing 
best-in-class, cost-effective, clinical and preclinical research. The MCRC 
provides end-to-end, novel cannabinoid drug discovery in conjunction with a 
talented, commercially-orientated, scientific team, capable of performing 
preclinical, phase 1, phase 2 and phase 3 trials.

Schedule 1
The material terms of the Binding Heads of Agreement between the Epsilon, THC 
Pharma (the Epsilon's wholly owned subsidiary, and owner of the Southport 
Facility), Valens, and Valens Australia Pty Ltd (Valens' wholly owned 
subsidiary) (Valens AU) are provided below:
1.	The Parties must use their best endeavours to execute the following 
documentation by 30 November 2021 to formalize the terms in the Binding Heads 
of Agreement:
	a. 	The Epsilon-Valens Management/Operational Consultancy
		(the "Operational Agreement"); and
	b.   	The Epsilon-Valens Export Supply Agreement (the "Export Supply 
Agreement")
		(together, the "Definitive Agreements").
2.	The conditions precedent for the execution of the Definitive Agreements are:
	a.    	Epsilon and THC Pharma being satisfied that their entry to the 
Definitive Agreements will not jeopardize any regulatory license or other 
authorization held by THC Pharma (including any license or authorization 
granted by the Therapeutic Goods Administration or the Office of Drug Control);
	b.  	Each of the Parties obtaining all required authorizations from any 
Government agency or regulatory body including, but not limited to, the 
Therapeutic Goods Administration and the Office of Drug Control.
3.	The material terms of the Operational Agreement are:
	a.    	Valens and/or Valens AU will provide management and operational 
consultancy services to THC Pharma in respect of its manufacture of medicinal 
cannabis and medicinal cannabis products for supply to the Australian and 
international markets, including a license to use Valens know-how and other 
intellectual property rights regarding the manufacture of medicinal cannabis 
products.
	b.   	During the term of the Operational Agreement, Valens will cover the cost 
of all THC Pharma's operational and capital expenditure. In return for priority 
access to THC Pharma's manufacturing output.
	c.    	Valens will leverage its preferred partnership with Cannvalate to sell 
GMP products manufactured in the Epsilon Southport Facility for sale in 
Australia or New Zealand.
	d.   	THC Pharma will pay Valens a management fee on all medicinal cannabis 
products manufactured by THC Pharma for Valens customers such that in effect 
THC Pharma retains a 'royalty' of 2.5% to 4% of sales revenue for all Valens 
customer products.
	e.   	THC Pharma will pay Valens a management fee on all medicinal products 
manufactured by THC Pharma for its own customers being the cost of production 
plus 25%, or such other amount the parties agree after good faith negotiations.
	f.    	Valens is required to use the Epsilon Southport Facility for all 
production of medicinal cannabis products for sale in Australian or New Zealand.
	g.   	The term of the agreement is for a minimum of five years, with an 
additional five year option, and a final 12 month option, each of which can be 
exercised at Valens's discretion.
4.	The Operational Agreement may otherwise only be terminated in the event of a 
material increase in the monthly forecasted costs or annual costs of the 
facility over a continuous period, in the event of a failure to meet regulatory 
and statutory requirements, a breach of law or regulation, a change of control 
of THC Pharma, or failure to meet specified confidential performance criteria 
under the Agreement for two consecutive quarters.The material terms of the 
Export Supply Agreement are:
	a.  	Valens AU appoints THC Pharma as its contract manufacturer for the 
manufacture of medicinal cannabis products in Australia at the order of Valens 
AU for export from Australia by Valens AU to Valens customers.
	b. 	Valens AU will be the 'sponsor' of the product for Australian compliance 
purposes and will be responsible for all regulatory obligations as the sponsor 
of the products.
	c.   	The term of the agreement is for a minimum of five years, with an 
additional five year option, and a final 12 month option, each of which can be 
exercised at Valens's discretion.

There can however be no assurance that the Definitive Agreement will be entered 
into.

Notice regarding Forward Looking Statements

All information included in this press release, including any information as to 
the future financial or operating performance and other statements of The 
Valens Company that express management's expectations or estimates of future 
performance, other than statements of historical fact, constitute 
forward-looking information or forward-looking statements within the meaning of 
applicable securities laws and are based on expectations, estimates and 
projections as of the date hereof. Forward-looking statements are included for 
the purpose of providing information about management's current expectations 
and plans relating to the future. Wherever possible, words such as "plans", 
"expects", "scheduled", "trends", "forecasts", "future", "indications", 
"potential", "estimates", "predicts", "anticipate", "to establish", "believe", 
"intend", "ability to", or statements that certain actions, events or results 
"may", "should", "could", "would", "might", "will", or are "likely" to be 
taken, occur or be achieved, or the negative of these words or other variations 
thereof, have been used to identify such forward-looking information. Specific 
forward-looking statements include, without limitation, all disclosure 
regarding future results of operations, future outcomes of transactions, 
economic conditions, and anticipated courses of action. Investors and other 
parties are advised that there is not necessarily any correlation between the 
number of SKUs manufactured and shipped and revenue and profit, and undue 
reliance should not be placed on such information.

The risks and uncertainties that may affect forward-looking statements include, 
among others, , Canadian regulatory risk, Australian regulatory risk, U.S. 
regulatory risk, U.S. border crossing and travel bans, the uncertainties, 
effects of and responses to the COVID-19 pandemic, reliance on licenses, 
expansion of facilities, competition, dependence on supply of cannabis and 
reliance on other key inputs, dependence on senior management and key 
personnel, general business risk and liability, regulation of the cannabis 
industry, change in laws, regulations and guidelines, compliance with laws, 
limited operating history, vulnerability to rising energy costs, unfavourable 
publicity or consumer perception, product liability, risks related to 
intellectual property, product recalls, difficulties with forecasts, management 
of growth and litigation, many of which are beyond the control of The Valens 
Company. For a more comprehensive discussion of the risks faced by The Valens 
Company, and which may cause the actual financial results, performance or 
achievements of The Valens Company to be materially different from estimated 
future results, performance or achievements expressed or implied by 
forward-looking information or forward-looking statements, please refer to The 
Valens Company's latest Annual Information Form filed with Canadian securities 
regulatory authorities at www.sedar.com or on The Valens Company's website at 
www.thevalenscompany.com. The risks described in such Annual Information Form 
are hereby incorporated by reference herein. Although the forward-looking 
statements contained herein reflect management's current beliefs and reasonable 
assumptions based upon information available to management as of the date 
hereof, The Valens Company cannot be certain that actual results will be 
consistent with such forward-looking information. The Valens Company cautions 
you not to place undue reliance upon any such forward-looking statements. The 
Valens Company disclaims any intention or obligation to update or revise any 
forward-looking statements whether as a result of new information, future 
events or otherwise, except as required by applicable law. Nothing herein 
should be construed as either an offer to sell or a solicitation to buy or sell 
securities of The Valens Company.

CONTACT : Jeff Fallows, President, The Valens Company, Investor Relations, 
ir@thevalenscompany.com, 1 647.956.8254; KCSA Strategic Communications, Phil 
Carlson / Elizabeth Barker, VLNS@kcsa.com, 1 212.896.1233 / 1 212.896.1203; 
Media, KCSA Strategic Communications, Anne Donohoe, adonohoe@kcsa.com, 1 
212.896.1265

Source - The Valens Company Inc.