OGI Sells 19.9% To British American Tobacco Company

 

Organigram signs product dev deal, financing with BAT

2021-03-11 07:28 ET - News Release

Mr. Greg Engel reports

ORGANIGRAM AND BAT FORM PRODUCT DEVELOPMENT COLLABORATION -- INCLUDES STRATEGIC INVESTMENT FROM BAT FOR 19.9% EQUITY INTEREST

Organigram Holdings Inc. has arranged a $221-million strategic investment from a wholly owned subsidiary of BAT. The BAT subsidiary has subscribed for approximately 58.3 million common shares of OGI, which represents a 19.9% equity interest1 on a post-transaction basis for total proceeds of approximately C$221 million ("Investment Proceeds") at a price per share of C$3.792, based on a five-day volume weighted average price on the TSX ending March 9, 2021.

Organigram Inc., a leading licensed cannabis producer and a subsidiary of Organigram Holdings Inc. (together, "Organigram" or "the Company"), and BAT have also entered into a Product Development Collaboration Agreement (the "PDC Agreement") pursuant to which a "Center of Excellence" will be established to focus on developing the next generation of cannabis products with an initial focus on CBD. The Center of Excellence will be located at Organigram's indoor facility in Moncton, New Brunswick, which holds the Health Canada licenses required to conduct research and development ("R&D") activities with cannabis products. Both companies will contribute scientists, researchers, and product developers to the Center of Excellence which will be governed and supervised by a steering committee consisting of an equal number of senior members from both companies. Under the terms of the PDC Agreement, both Organigram and BAT have access to certain of each other's intellectual property ("IP") and, subject to certain limitations, have the right to independently, globally commercialize the products, technologies and IP created by the Center of Excellence pursuant to the PDC Agreement.

"This is a tremendous milestone in the evolution of Organigram. It is instrumental in advancing our commitment to offering consumers innovative cannabis products and to furthering our long-term international strategy," said Greg Engel, Chief Executive Officer of Organigram. "We have been extremely selective about aligning with a strategic partner and, in BAT, we've found a leading consumer goods business with sophisticated management, innovative product platforms, an impressive dedication to research and development, deep consumer insights, regulatory expertise and a commitment to responsible stewardship and consumer safety among many other enviable attributes. This collaboration is the culmination of extensive discussions and workshops and in-depth due diligence."

Dr. David O'Reilly, Director, Scientific Research at BAT, commented: "Today's announcement underscores BAT's commitment to accelerating our transformation and building A Better Tomorrow. Our multi-category, consumer-centric approach, which is key to our transformation, aims to provide choice and meet the evolving needs of adult consumers. Choice that provides reduced risk alternatives2 to combustible cigarettes, as well as going beyond tobacco and nicotine into new and exciting areas of product innovation.

We believe this collaboration has significant potential to enhance our activities, allowing us to combine our world-class expertise while enabling scientists from both BAT and Organigram to work closely together and share information real-time. We know that in R&D this is how you make real breakthroughs and accelerate progress.

We have been impressed by the strong management team and culture at Organigram. This collaboration aligns with our long-term strategy and will enable us to work with Organigram at an R&D level, as well contributing to their wider operations."

Strategic Rationale for the Deal

BAT's investment in Organigram and the PDC Agreement is expected to strengthen Organigram's balance sheet, accelerate its R&D program and product development activities and bolster its ability to enter the U.S. and other international markets. "In our view, the cannabis industry is still in the nascent stages of product development. We believe that product innovation backed by core fundamental R&D is necessary to establish a long-term competitive advantage in the cannabis industry," stated Paolo De Luca, the Company's Chief Strategic Officer. "This strategic collaboration strengthens our ability to deliver innovative, differentiated products that appeal to adult consumers and we expect it to be transformational for Organigram and its shareholders."

Organigram believes BAT's investment and the PDC will benefit the Company as follows:

• Accelerates and strengthens Organigram's R&D and product development activities, including granting access to certain BAT-owned IP. The Center of Excellence provides Organigram the opportunity to closely collaborate with BAT, a leading global consumer business with extensive expertise and experience in R&D, on the development of innovative and differentiated cannabis products, IP and technologies. The significant injection of capital from BAT also enables Organigram to further invest in its own R&D and product development activities. In addition, Organigram will gain access to certain BAT IP for the purpose of undertaking R&D activities under the PDC Agreement.
• Raises significant capital to invest in growth opportunities, including entering the United States and other international markets. With the significant capital injection, Organigram is even better positioned to expand into the U.S. and further international markets at the appropriate time and subject to applicable law. Upon closing, Organigram will have pro-forma cash and short-term investments of approximately C$296 million (of which approximately C$30 million will be reserved in order to satisfy certain of Organigram's obligations under the PDC Agreement and the balance of which can be used, among other things, for growth opportunities and other strategic investments including advancing Organigram's international strategy). Under the PDC Agreement, the Company will be granted a worldwide, royalty-free, sub-licensable, perpetual license to exploit IP developed under the PDC in any field. This license which is non-exclusive outside of Canada and sole in Canada will also enhance Organigram's ability to enter markets outside of Canada, including through sublicensing arrangements with established operators.
• Allows Organigram to leverage BAT's expertise for its wider operations through the Centre of Excellence and BAT's representation on Organigram's Board of Directors ("Board"). BAT is a leading consumer goods business with tremendous expertise and experience accumulated over more than a century in research and development and product innovation. Organigram will be provided direct access to BAT's expertise through the Center of Excellence staff seconded from BAT (including members of the steering committee which will oversee the Center of Excellence, as well as a group of scientists, researchers, and product developers).

BAT is also entitled to add two Board members to Organigram's Board.? At closing, Organigram added one BAT nominee, Mr. Jeyan Heper, to its Board and another nominee is expected to be added in the near term.? Mr. Heper, who is a Group Category Director at BAT, has over 23 years of diverse management, strategic leadership, and mergers and acquisitions experience at global companies including BAT, Procter & Gamble, Danone and LifeStyles Healthcare. His expertise includes growing value and volume share through global brand and equity building and consumer marketing. Both nominees are expected to bring deep R&D, product and strategic expertise to further complement Organigram's existing Board capabilities as well as extend its international presence.? Further particulars regarding BAT's second nominee and that nominee's credentials will be provided upon appointment.

Key Transaction Terms

Investor Rights

Contemporaneously with the closing, Organigram and BAT entered into an investor rights agreement (the "Investor Rights Agreement") providing BAT with certain rights including its right to participate in equity issuances to maintain its percentage shareholding, subject to customary exceptions, and periodic top-up rights to permit maintenance of its percentage ownership following exempt issuances.

The Investor Rights Agreement also includes customary pro rata piggy-back registration rights in favour of BAT, and certain share transfer restrictions for BAT's shareholding interests in OGI.

Board Representation

BAT's board representation rights under the Investor Rights Agreement, entitle BAT to appoint (i) 20% of the Board for so long as it holds at least 15% of the issued and outstanding common shares in OGI from time to time and (ii) 10% of the Board so long as BAT holds at least 10% of the issued and outstanding common shares of Organigram from time to time.

Product Development Collaboration

Pursuant to the terms of the PDC Agreement, approximately C$30 million of the Investment Proceeds shall be reserved in order to satisfy certain of Organigram's obligations under the PDC Agreement (the "Allocated Investment Proceeds"), including Organigram's portion of its funding obligations under a mutually agreed budget for the Center of Excellence, and then (together with the balance of the net Investment Proceeds) for general corporate purposes, subject to certain proceed restrictions. Costs relating to the Center of Excellence will be funded equally by Organigram and BAT.

Pursuant to the PDC Agreement, Organigram and BAT have agreed to jointly develop cannabis vapour products, cannabis oral products and any other products, IP or technologies the parties mutually agree to develop. BAT will own all IP developed under this collaboration and will grant to Organigram a royalty-free, perpetual, global licence to all such IP. Each party has also agreed to grant to the other a non-exclusive, perpetual and irrevocable license to certain existing IP of such party and its affiliates for purposes of conducting the development activities and exploiting the products, technologies and IP created by the Centre of Excellence pursuant to the PDC Agreement, subject to certain restrictions.

Advisors

BMO Capital Markets acted as exclusive financial advisor to Organigram and Goodmans LLP acted as its primary legal advisor with DLA Piper as its European counsel.

Herbert Smith Freehills LLP and Stikeman Elliott LLP acted as legal advisors to BAT.

Conference Call and Webcast

The Company will host a conference call and webcast to discuss this announcement:

Date: March 11, 2021 Time: 8:00am Eastern Time

To ensure you are connected for the full call, we suggest registering a minimum of 10 minutes before the start of the call. After registering, a confirmation will be sent through email, including dial in details and unique conference call codes for entry. Registration is open through the live call.

A replay of the webcast will be available within 24 hours after the conclusion of the call at https://www.organigram.ca/investors and will be archived for a period of 90 days following the call.

About Organigram Holdings Inc.

Organigram Holdings Inc. is a NASDAQ Global Select and TSX listed company whose wholly owned subsidiary, Organigram Inc., is a licensed producer of cannabis and cannabis-derived products in Canada.?

Organigram is focused on producing high-quality, indoor-grown cannabis for patients and adult recreational consumers in Canada, as well as developing international business partnerships to extend the Company's global footprint. Organigram has also developed a portfolio of legal adult use recreational cannabis brands including The Edison Cannabis Company, SHRED and Trailblazer. Organigram's facility?is located in?Moncton, New Brunswick and the Company is regulated by the?Cannabis Act and the?Cannabis Regulations?(Canada).

We seek Safe Harbor.

© 2021 Canjex Publishing Ltd. All rights reserved.

Apli-TSX Appili Therapeutics, an anti-infective biotech headquartered in Nova Scotia, Canada,

 

Appili's CRO Selection Reects Realities of Clinical Studies in a Pandemic From The Editor | February 25, 2021 By Ed Miseta, Chief Editor, Clinical Leader Follow Me On Twitter @EdClinical In 2020, Appili Therapeutics, an anti-infective biotech headquartered in Nova Scotia, Canada, needed to conduct a clinical trial for favipiravir (Avigan), an antiviral the company was evaluating in multiple Phase 3 trials as a potential treatment for COVID-19. Appili has five programs in its pipeline, and Avigan is the first to make it to a Phase 3 trial. 

The CRO selection process was tightly linked to the fact that the company would be conducting the study on COVID-infected patients during a global pandemic. Before starting that selection process, the company had to understand its core requirements, as those requirements are different during a pandemic than they are under typical conditions. “In a normal situation, you have sufficient time to conduct your processes,” says Dr. Yoav Golan, chief medical officer for Appili. “When you’re operating during a pandemic, you may not be able to complete a trial, or may not be able to do so in a timely manner. 

For some therapeutics, you also understand the epidemiology of the disease, which likely has not changed in quite some time. When dealing with a new virus, you do not have that advantage.” One of Appili’s core requirements was a nimble recruitment process. The Phase 3 trial would take place in multiple countries, and the pandemic made recruitment a concern. Golan notes that a study can be run in one country, but then be forced to relocate as a result of the virus spread. If the number of cases in a country were suddenly declining, that could make patient recruitment very difficult. Appili’s CRO vetting process focused on the ability to operate internationally. “In some countries the pandemic was coming in waves, but in other countries, the cases might suddenly be declining,” he states.

 “You could spend months preparing for a study, only to have enrollment stall because of a sudden decline in the number of cases. We knew that 3/10/2021 Appili’s CRO Selection Reflects Realities of Clinical Studies in a Pandemic https://www.clinicalleader.com/doc/appili-s-cro-selection-reflects-realities-of-clinical-studies-in-a-pandemic-0001 2/5 Dr. Yoav Golan, chief medical officer, Appili Therapeutics could end up being a major hurdle, and one that could disrupt a trial.” He stipulated that the CRO would need to be able to operate fluidly in response to global public health trends. A Conclusive Study Golan notes the company also wanted the study to be conclusive. 

Running a study during a pandemic could produce results that are inconclusive, especially if the study is small by design. To complete the study, he felt flexibility to enable a large-scale study would have to be built into it. “We might design a study to enroll patients in countries A, B, and C,” he says. 

“However, by mid-study you may find the pandemic is moving into other countries. If your CRO does not have a presence in those countries, you will be locked into A, B, and C and have to wait for the next wave to hit. That might make it impossible for you to complete the study, or to do so in a timely manner.” To recruit the necessary number of subjects for the scale Appili had in mind for its pivotal study, flexibility and global access were paramount. According to Golan, some of the challenges the company faced were more technical in nature. 

For example, understanding the amount of time it would take for regulators to approve the IND so the study could get underway. In some cases, it could take weeks, in other cases it might be months. If the review was going to take too long, you might consider avoiding that country altogether, even if it looked good in all other respects. Ultimately, the quicker the study is run, the faster a potential therapy can get to patients worldwide.

“Once we knew our core requirements and understood the challenges we faced, we were able to begin the search for a CRO,” adds Golan. “The information we gathered would allow us to use metrics that were relevant to our study to measure the abilities of the CROs we interviewed. At the end of the day, the ability to run the study determined our choice of the CRO.” 

For Appili, the first requirement that CRO partners had to meet was experience working with COVID. Potential partners had to be currently working on a COVID study or have completed one. That history would show not only familiarity with the virus, but the ability of the CRO to operate in pandemic situations. More importantly, it would demonstrate that the CRO had acquired some experience and understanding of the pitfalls that could arise in a COVID study and have the foresight to avoid them. 

It would also show that the CRO had relationships with the sites with which Appili would need to work. 3/10/2021 Appili’s CRO Selection Reflects Realities of Clinical Studies in a Pandemic https://www.clinicalleader.com/doc/appili-s-cro-selection-reflects-realities-of-clinical-studies-in-a-pandemic-0001 3/5 “We also wanted a CRO that had experience running studies in outpatient centers in communities,” says Golan. “We knew we would be working with community outpatient centers, which is more difficult than working with hospitals. Community centers have fewer resources. Those sites also work with COVID-infected patients with mild to severe symptoms who are in quarantine. We did not want to violate those quarantine requirements. A CRO that has worked with COVID and those organizations in the past would possess the experience needed to manage the study as well as the ability to identify sites and investigators.

 The expectations for an outpatient study are not the same as for an inpatient study and we wanted a CRO who was familiar with the differences.” A CRO Competition Appili is a small company with about 20 employees, but it still wanted its CRO selection process to be competitive. The COVID study the company was preparing to launch was large and carried a substantial budget. For that reason, it was not difficult to find CROs who were interested in the project. Because the trial would take place across borders, Appili opted to approach CROs that fell into the large and mid-sized categories. Golan felt mid-sized CROs tended to be more flexible and fast moving and had more of a hands-on approach when dealing with smaller clients. 

At the same time, he felt large CROs had a wider global presence and would be better suited to run a trial conducted in multiple countries. They would also have greater access to the resources required to run a global trial., The Larger CROs also tend to be more expensive. After reviewing the companies that could potentially be a good fit for the trial, Appili narrowed the list to three potential CROs. Two were large (top 10) CROs and one was a medium-sized firm. “We had all three service providers come in and share their experience with COVID, running a successful COVID trial, and running a community-based study,” he says. “We also wanted to know that they wanted to perform the trial and that they had sufficient resources to devote to it. 

The CROs brought a team of people to these meetings, which lasted about two hours, and worked to convince us they were prepared to meet our core requirements.” Golan notes the medium-sized company had partnerships in several countries where Appili intended to conduct the trial, including the U.S.

The medium-sized CRO also seemed to be the best prepared, the most responsive, and the hungriest of the three CROs. “In talking to them we felt they were ready for our study,” states Golan. “They did far more than required to communicate their readiness to us.” A Surprising Choice 3/10/2021 Appili’s CRO Selection Reflects Realities of Clinical Studies in a Pandemic https://www.clinicalleader.com/doc/appili-s-cro-selection-reflects-realities-of-clinical-studies-in-a-pandemic-0001 4/5 Login Name Email Website (optional) Comment as a Guest, or login: There are no comments posted yet. Be the first one! Comments Post a new comment Enter text right here! 

By now you’re thinking Appili must have opted to partner with the medium-sized firm. If you thought that, you would be wrong. In the end, and after carefully weighing many considerations, Appili decided to partner with a CRO with the best ability to meet its research design criteria. 

“We knew the situation we were in and had to use the realities of that situation in our decision-making process,” says Golan. “We selected the large, multinational CRO and the main reason was their global presence. This trial could require us to go to countries that are seeing rising numbers of COVID cases. We needed the ability to quickly make that move. If our CRO did not have a presence in a country, that would require them to create partnerships, which takes time. Although we felt the medium-sized firm was comparable to the large CROs in every other way, that global presence alone was the driving factor in our decision. To keep patients properly quarantined, remote monitoring was necessary. 

The trial used a telehealth platform that included patient diaries and a pulse oximeter that allowed patients to measure their oxygen saturation during the telehealth interview. The devices were essentially out-of-the-box products provided by technology vendors selected by Appili after search of available products. Finally, Appili’s size contributed to its success in establishing trial operations during a pandemic. 

“There are a few traits that I believe are necessary,” adds Golan. “You must have the ability to move fast and make decisions quickly. Your company needs to be flexible and cannot be too bureaucratic. The right people, not just more people, need to be involved in making decisions. 

I believe it is easier to have those traits in a smaller company like Appili than a large corporation.”

https://www.clinicalleader.com/doc/appili-s-cro-selection-reflects-realities-of-clinical-studies-in-a-pandemic-0001