albertainnovates.ca · Web viewThis must include: income statement, balance sheet, statement of cash flows, and statement of retained earnings. If year-end is greater than 3 months

AICE – MARKET ACCESSAPPLICATION

Submission Deadline: Open Call

Note: This is a copy of the online Application form and is provided as an aid to writing your

Application. This Application form will NOT be accepted for review. To submit an Application, please

visit our online application portal.

Introduction:The following Application form has been developed as part of Accelerating Innovations into CarE (AICE)

– Market Access. It is essential that you have read, and that you understand, the AICE-Market Access

Program Guide (‘the Guide’) before completing this form. Throughout the Application, be sure to

highlight your underlying assumptions and cite any relevant sources of information. If you require

assistance in completing your Application, please contact: [email protected]

Application Terms and Conditions:Alberta Innovates will only provide copies of the Application, including any attachments to both the

Applicant Representatives. Accordingly, any changes of the Applicant Representatives should be to an

individual who has the authority and permission to see the Application and any attachments.

All capitalized words or terms which are not defined within this Application have the respective

meaning as set out in the AICE Program Guide (the ‘Guide’). In this Application, the term “you” and

“Applicant” are used interchangeably; the term “Applicants” collectively represents the SME Applicant

and Testing Site Applicant. You can view a copy of the Guide here.

All Investment determinations made by Alberta Innovates (including declining an Investment) are final,

non-appealable and binding. Notwithstanding the Applicants and the Project meeting the minimum

requirements or eligibility criteria, or the results of any evaluation or recommendation or the

involvement of an agent of Alberta Innovates, Alberta Innovates retains sole and absolute discretion

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https://albertainnovates.ca/focus-areas/health-innovation-and-platforms/aice-market-access/

mailto:[email protected]

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regarding Investment determinations. Such determinations include whether to invest, the amount of

the Investment (if any), and the terms and conditions of such Investment. Further, Alberta Innovates,

in its sole and absolute discretion, has the right to decline any Application at any stage of the review

process for any reason and does not owe a duty of reasonableness to the Applicants in making its

Investment determination. By submitting this Application, the Applicants acknowledge that Alberta

Innovates has no obligation to the Applicants during the course of receiving and reviewing the

Application or in making its Investment determination.

Alberta Innovates will use its reasonable commercial efforts to inform the Applicants of the Investment

determination made in respect of an Application in a timely fashion. Any failure to inform the

Applicants of the Investment determination regarding an Application will not result in any obligation or

liability of Alberta Innovates to the Applicants or any other interested party.

The Application may be reviewed by internal and external reviewers of Alberta Innovates. These

experts will provide their recommendations to Alberta Innovates, and may also voluntarily provide

constructive feedback meant for the Applicants. Alberta Innovates will make the final determination

regarding approval of Applications and may at any time request an interview with the Applicants.

Incomplete Applications will not be considered or reviewed.

Alberta Innovates may also, in its sole and absolute discretion, forward to the Applicants the

constructive feedback, but will not provide any information regarding an expert’s personal

information. Applicants are not entitled to access any information regarding the experts, including

personal information, nor are they entitled to access or review the expert’s recommendation.

Alberta Innovates has the right, as determined in its sole and absolute discretion, to impose a life-time

limit on the number of Applications Applicants may submit.

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Freedom of Information and Protection of Privacy Act (Alberta) (“FOIP”):Alberta Innovates is governed by FOIP. This means Alberta Innovates can be compelled to disclose the

information received under this Application, or other information delivered to Alberta Innovates in

relation to a Project, when an access request is made by anyone in the general public.

In the event an access request is received by Alberta Innovates, exceptions to disclosure within FOIP

may apply. If an exception to disclosure applies, certain information may be withheld from disclosure.

Applicants are encouraged to familiarize themselves with FOIP. Information regarding FOIP can be

found at http://www.servicealberta.ca/foip/. Should you have any questions about the collection of

this information, you may contact Graham Anderson at 780-306-1329.

Publication of Non-Confidential and Aggregate Information by Alberta

Innovates: Alberta Innovates may (1) publish and/or disseminate in the public domain certain information

contained within this Application as a way to promote success stories about innovation in the Province

of Alberta and/or (2) use certain information contained within this Application as a way to verify

information contained in this Application. On these bases, Alberta Innovates has indicated which

information provided in the Application has been deemed to be confidential and all other information

is subject to disclosure by Alberta Innovates in its sole discretion at any time.

In addition, Alberta Innovates may aggregate information within this Application for the purposes of

reporting or dissemination in the public domain. For clarity, ‘aggregate’ means removal of personal

identifiers such as names, locations and addresses of the Applicants and employees, and combining

such information with that of other Applicants.

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Section 1: General Information1. Project Title (Non-Confidential)

Click or tap here to enter text.

2. SME Applicant Information (Non-Confidential) Legal Name of SME Applicant:


Trade Name of SME Applicant:


Address: Click or tap here to enter text.

Business Number: Click or tap here to enter text.

Percentage (%) Alberta Ownership


Jurisdiction of incorporation

Click or tap here to enter text. Phone Number:


Website: Click or tap here to enter text.

SME Applicant Representative

Name: Click or tap here to enter text.

Title: Click or tap here to enter text. Phone Number:


Email: Click or tap here to enter text.

Signature: Click or tap here to enter text.

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3. Testing Site Applicant Information (Non-Confidential)Legal Name of Testing Site Applicant:


Trade Name of Testing Site Applicant:


Address: Click or tap here to enter text.

Business Number: Click or tap here to enter text.

Percentage (%) Alberta Ownership


Jurisdiction of incorporation

Click or tap here to enter text. Phone Number:


Website: Click or tap here to enter text.

Testing Site Applicant Representative

Name: Click or tap here to enter text.

Title: Click or tap here to enter text. Phone Number:


Email: Click or tap here to enter text.

Signature: Click or tap here to enter text.

4. Additional Collaborators – this includes other partners who are involved in the Project beyond the SME and Testing Site. Examples could include additional secondary testing sites or consulting firms that will be involved in the project (e.g. for economic analysis or other research support).

Organization Organization Representative General Role in Project

Click or tap here to enter text. Click or tap here to enter text. Click or tap here to enter text.




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5. Relationship with Alberta Innovates (Confidential)

Did you work with an Alberta Innovates representative prior to completing this application?

☐ YES ☐ NO

If you selected YES, provide the name(s) of the individual(s) and their position within Alberta Innovates:


Are there any existing relationships between the SME Applicant or Testing Site Applicant, the SME Applicant or Testing Site Applicant Representative, or any of the SME Applicant or Testing Site Applicant directors or shareholders with any of the Alberta Innovates Corporations or the Ministry of Economic Development and Trade?

☐ YES ☐ NO

If you selected YES to the above question, please provide an explanation of the relationship(s).


Has the SME Applicant or Testing Site Applicant previously applied for an investment from the AICE – Market Access Program?

☐ YES ☐ NO

Has the SME Applicant or Testing Site Applicant applied under a different name?

☐ YES ☐ NO

Is this a re-application?

☐ YES ☐ NO

Has the SME Applicant or Testing Site Applicant, or SME Applicant or Testing Site Applicant Representative, ever applied for Alberta Innovates funding in the past OTHER THAN AICE – Market Access (including AI’s legacy corporations AITF, AIHS, AI Bio, or AI-EES)?

☐ YES ☐ NO

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Non-Confidential AbstractPlease provide a high-level non-confidential overview of the problem you are trying to solve, how your innovation solves the problem, the proposed Project and its potential impact. Please Note: This section may be provided to a diverse set of stakeholders including the public. (limit 500 words)


Section 2: Innovation Opportunity (Confidential)

The Problem / Solution Relationship: The objective of this section is to identify and characterize the relationship between the problem identified and the solution being proposed.

Existing Problem (limit 400 words): Define the problem the innovation is addressing. Explain how you know this to be a problem. The problem should be communicated in quantifiable terms and demonstrate substantial market need for the innovation. From the customer’s perspective, how serious is the problem and why?


Proposed Innovation Solution (limit 400 words): Describe the innovation offering in its current status, including what it is and how it addresses the problem from a technical perspective. Provide any supporting evidence generated to date that indicates its viability as a solution to the problem.


Current Technology Readiness Level (TRL)*

☐ TRL 1 ☐ TRL 2 ☐ TRL 3

☐ TRL 4 ☐ TRL 5 ☐ TRL 6

☐ TRL 7 ☐ TRL 8 ☐ TRL 9

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*Information regarding TRL classification can be found here:https://albertainnovates.ca/wp-content/uploads/2018/05/Technology-Readiness-Levels.pdf

Research and Innovation Priorities: Which of the following research and innovation priorities does the innovation or this Project align with:

☐ Data-Enabled Innovation ☐ Digital Tech for Business Transformation

☐ Innovative Production and Distribution

Please explain your selection (limit 100 words)Click or tap here to enter text.

Path to Market: The objective of this section is to ensure that a path to successful market adoption has been characterized for the innovation.

Market Penetration (limit 800 words): Who are the target customer segments, and why is this an ideal segment? How will the SME Applicant target, attract, retain and grow the customer base? What is the total addressable market and realistic market penetration within the next 5 years? How will this AICE-Market Access Project support the broader market entry strategy?


Competitive Landscape (limit 700 words): Describe how the problem is currently being solved using existing products, services or practices. Describe the competitive landscape in detail including direct and indirect competitors along with their comparative advantages and disadvantages.


Value Proposition (limit 700 words): What are the compelling arguments that a customer would choose to use this innovation in relation to the current standard or other competitors? Provide value propositions from the perspective of individuals relevant to adoption, which may include patients, clinicians, and payors/purchasers.


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https://albertainnovates.ca/wp-content/uploads/2018/05/Technology-Readiness-Levels.pdf



Revenue Model: The objective of this section is to identify the framework and timeline by which the commercialized innovation will become profitable.

Pricing Structure (limit 500 words): What is the revenue model for this innovation? Why was this revenue model chosen, and how has it been validated? What are the innovation’s unit economics (cost and revenue per unit)?


Financial Projections: Provide a minimum 3-year financial forecast for the innovation. Be sure to adequately identify and describe any assumptions. Financial projections should be in the form of an income statement (profit and loss) and include projected cash balances. Please specifically identify large capital expenditures such as property, equipment and inventory, along with points in the growth phase that will require additional private investment to achieve traction.


Barriers to Market – The following section is intended to identify regulatory risk, intellectual property risk and other barriers to market access, along with strategies for managing these risks moving forward.

Innovation Ownership and Intellectual Property (IP) (limit 400 words): Identify the owner of this innovation, including any relevant licensing assignments or equity obligations. If IP will be generated as part of this Project, how will ownership be determined between the SME, Testing Site, and other collaborators? Reference any relevant patents awarded or pending (i.e. application and/or patent numbers). If no patent exists, provide information regarding any copyrights or a plan for protecting trade secrets.


Regulatory Readiness – with regards to Health Canada, FDA or equivalent, the innovation:

☐ has secured all necessary regulatory approvals to sell the innovation on the market*

☐ has secured an ITA, IND, or equivalent*

☐ is not classified as a medical device, pharmaceutical or natural health product*

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☐ other*

Please explain your selection, including any determinations regarding regulatory classification, the innovation’s intended use statement, and justification for such classification (limit 300 words).


*Please append evidence supporting the innovation’s regulatory status. This could include correspondence with regulatory agencies or regulatory consultants.

Barriers to Adoption (limit 600 words): Identify any barriers that may present challenges in commercializing the innovation. What is the strategy for overcoming these barriers, and how will this AICE-Market Access Project support? Barriers could include Health Canada or FDA regulatory approval, other certification bodies, a need to meet accreditation standards, a need to be compliant with privacy legislation, a need for attracting private investment, or a need for additional operational/clinical evidence to inform adoption by key adoption decision makers.


Section 3: Project Implementation (Confidential)

The Project: The objective of this section is to clearly and concisely identify the blueprint for completing this Project.

Project Start Date:

Click or tap here to enter text. Project End Date:


Total Alberta Innovates Funding Requested (up to a maximum of $300,000):

$ Click or tap here to enter text.

Decision Makers (limit 400 words): Who are the key decision makers that this project is designed to generate evidence for? Clearly describe why these decision makers were chosen as the focus of this AICE-Market Access Project and how they have been engaged to date. What is the plan to continuously engage them throughout the Project? This may include regulatory, investment, clinical, operations, purchasing and

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reimbursement decision makers.


Project Hypotheses (limit 200 words): What metrics have been identified by decision makers as critical in assessing the innovation. Demonstrate at least one clear hypothesis that will be tested during the Project to inform market adoption. The hypotheses should address key metrics required by decision makers.


Methodology & Deliverables (limit 2,500 words): Include a detailed description of how the hypothesis will be tested and evaluated along with specific timelines. The methodology should be detailed enough that it is reproducible by a third party. Clearly describe in detail how metrics will be measured, who will be measuring them, and when they will be measured. Indicate deliverables that will be generated throughout the Project. It may be important to include a sample size calculation based on expected effect sizes, description of experimental design or guidelines, inclusion and exclusion criteria, and protocol for collecting data. Most AICE-Market Access Projects also require ethics approval.


Project Milestones (limit 500 words): Indicate milestones for each phase of the Project, based on the performance metrics and/or deliverables previously identified. This must include clear “go / no-go” decision points that will lead to either a continuation or termination of the Project.


Risks & Mitigations (limit 500 words): Provide a comprehensive risk assessment as it relates to the Project, including mitigation tactics.


Project Governance (limit 300 words): Clearly delineate SME Applicant and Test Site Applicant expectations, roles and responsibilities, decision making processes and communication channels. Explain what governance structures will be used to manage project risks and facilitate decision making if disagreements occur between parties during the Project.


Level of Commitment (limit 300 words): Identify any post Project commitments that are in place should the

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Project successfully demonstrate the innovation’s value. If no solid commitments are in place, what are the next phases for adopting this innovation within the Test Site? Please share any formal agreements such as letters of intent to purchase the innovation, given successful results, that are in effect.


Project Team: The objective of this section is to describe how the relationship between the SME Applicant and Testing Site Applicant will drive success of the Project.

Value of Partnership (limit 400 words): Describe why this partnership is valuable in supporting the broader mission or strategy of each partner. Be sure to include information from the perspective of the Test Site Applicant (e.g. how does this partnership enable you to provide better care?)) and the SME Applicant (e.g. how does this partnership support your broader market entry strategy?)

Describe previous business relationships between the SME Applicant and Test Site Applicant, be sure to identify any real or perceived conflicts of interest. Where conflicts exist, explain how they will be managed.


Key Project Personnel: Who are the key people that will participate in the Project? What is their relevant experience with regards to carrying out research projects of this nature?

(Add rows for additional Personnel)

Organization: Click or tap here to enter text.

Contact Name: Click or tap here to enter text.

Position/Department: Click or tap here to enter text.

Contact Phone Number: Click or tap here to enter text.

Contact Email: Click or tap here to enter text.

Experience:(limit 150 words)


Roles and Responsibilities (limit 150 words)


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Estimated Budget Information

In an attachment, provide a detailed budget for the Project. At a minimum, the budget should include the headers identified in the table below, along with totals for each line item and funding contributor. For each budget line item, identify which funding source - Alberta Innovates (“AI”), the SME Applicant or the Test Site Applicant - will be used to cover the cost, and whether the support will be cash or in-kind. Add additional columns for other contributors. Provide a clear justification of the budget item. For in-kind contributions, provide justification for the valuation. Please see the Guide for a summary of eligible and ineligible project expenses, along with a description of in-kind contributions.

Please enter the budget totals in the following table:

Budget Line Item

Funds Requested from AI (max 50%

SME Applicant Contribution

Test Site Applicant Contribution

Total: Justification for Budget Line

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total project budget up to

$300,000)

(min 25% total project budget) Item

Cash In Kind Cash In Kind

Total: $Click here to enter text.

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enter text.

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enter text.

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Section 4: Business Readiness (Confidential)

Business Readiness: The objective of this section is to understand the SME Applicant’s capabilities in relation to prior success commercializing innovations. This section also aims to identify and characterize the alignment of current operations or capabilities with the proposed innovation. Note: Alberta Innovates will accept the SME Applicant’s business plan (PDF or PowerPoint) in place of completing this section; however, please specifically indicate (i.e. page or slide number) where the respective information can be found.

Current Business (limit 500 words): Briefly describe the SME Applicant’s history and identify any revenue generating products or services.


Strength of the Management Team (limit 500 words): Describe the SME Applicant management structure, highlighting key individuals on the team and their relevant technical, business and/or commercialization experience.


Resources and Operating Activities (limit 700 words): What resources and operating activities will the SME Applicant require in order to commercialize the innovation? Which resources and capabilities does the SME Applicant currently possess, which will need to be acquired, and which will be provided by other partners? Resources could include physical, financial, intellectual, and human inputs. Operating activities could include sales, business development, manufacturing, software development/maintenance, deliveries, installations, etc.


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Overall Financial Position: The objective of this section is to gain an understanding of historical capital investments into the business and the current financial standing of the SME Applicant as a whole.

Financial Statements: Attach the SME Applicant’s most current accountant prepared year-end financial statements. This must include: income statement, balance sheet, statement of cash flows, and statement of retained earnings. If year-end is greater than 3 months prior to application date, please provide the most recent bank statements for any relevant accounts.

Historical Investments: Please fill out the following Sources of Support Table to communicate all historical investments into the business and the portion of those investments that could be applied to a Project under the Guide of this Program.

CategoryIf Permissible by the Investment Source, please provide their

name

Year(s) Received

Column A Column B

Total Funding Provided

Portion of Column A being applied to the

Project* named in this Application

Federal Government Grants & Investments

Click here to enter text.




Provincial/ Territorial Grants & Investments





Alberta InnovatesClick here to enter

text.Click here to enter

text.

$Click here to enter

text.


Angel InvestorsClick here to enter


text.$Click here to

enter text.$Click here to enter text.

Venture CapitalistClick here to enter


text.$Click here to


Other Financial Investors





Strategic InvestorsClick here to enter


text.$Click here to


Founder/ Family/Friends





Applicant reinvestment





Not-For Profit Grants & Investments





Total Funding from All Sources $Click here $Click here to enter text.

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to enter text.

*Please note that Alberta Innovates may contact the customer(s) or party(s) you list for verification of information in the “Source of Support Table”, without notice

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Baseline Business Metrics: This section will be used to capture baseline business metrics that will be used at a further date to determine the economic impact generated from this investment.

How many T4 salaried individuals do you employ in AB?

How many T4 salaried individuals do you employ outside AB?

Indicate your gross sales for the last 3 fiscal years (not including grants)YEAR $RevenueYEAR $RevenueYEAR $Revenue

Section 5: Potential for Alberta Impact (Confidential)

Alberta Impact: The objective of this section is to understand the potential Alberta impact that will be realized upon successful commercialization of this innovation.

Alberta Economic Impact (limit 500 words): Clearly describe the economic impacts to Alberta should this innovation be commercialized. Be sure to describe assumptions on the potential for revenue growth, diversification/strengthening of the Alberta economy, job growth (including types of jobs), follow-on investment and plans for export. Information provided should be specific, quantitative, and attached to expected timelines and projections.


Alberta Health Impact (limit 500 words): Identify how this innovation will impact the health system in Alberta at an operational level or patient level. This should include specific identification of the population of patients and/or the clinical setting(s) that will be impacted. From the operational perspective, this could include improved efficiencies, economics or occupational health and safety factors. For patient populations, outcomes could include improvement in quality adjusted life years or any other metrics relating to the morbidity being addressed. Information provided should be specific, quantitative, and attached to expected timelines and projections.


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Supporting Documentation:The following documents are not mandatory but may be provided in support of the application:

a) Business plan(s)

b) Photos / screen shots of the innovation interface

c) Charts or process maps that illustrate project methodology, governance structures, etc

d) External cost quotes

e) Patent/license details

f) Investment pitch deck

g) White papers or peer reviewed publications

h) Independent market assessments

i) Quantitative test results – bench scale or previous field trials

j) Letters of support – e.g. Memorandum of Understanding (MOU) or Letter of Intent (LOI)

k) Partnerships, joint ventures, research collaborations

l) Any agreements such as, sales and/or distribution agreements

Consent and Declaration of Applicants:By submitting this Application, including any supporting documentation, we, in our capacity as the authorized representatives of the SME Applicant and Test Site Applicant (“Applicants”), legally represent for and on behalf of the Applicants that:

1. the Applicants provide explicit consent to the disclosure of the information identified within the Application by Alberta Innovates in its sole discretion;

2. the Applicant Representatives are legally authorized to submit this Application for and on behalf of the Applicants and have the requisite power to legally bind the Applicants;

3. the Applicant Representatives have read and understand the AICE – Market Access Program Guide;

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4. if the financial statements attached to this Application are unaudited internally prepared financial statements, the SME Applicant certifies that financial statements prepared on an audited or review engagement basis were never prepared for the period ended as at the immediately prior fiscal year end of the SME Applicant;

5. the Applicants understand the Guide;

6. the Applicants meets all the eligibility requirements for an Investment under the AICE – Market Access Program as set out in the Guide;

7. the Applicants agree and consent to Alberta Innovates contacting the individual(s) or company(s) listed as customer(s) or strategic partnership(s) in this Application as part of Alberta Innovates’ evaluation of the Application;

8. all information contained in this Application including but not limited to the Project and supporting documentation, is true and accurate;

9. the Applicants acknowledge that failure to provide true and accurate information in this Application will result in automatic rejection of the Application;

10. submission of this Application does not obligate Alberta Innovates to make an Investment in the Project and Alberta Innovates has sole and absolute discretion in making its Investment determination; and

11. if this Application is approved, Alberta Innovates and the Applicants must execute an Investment Agreement which provides additional contractual terms and conditions governing the Investment made by Alberta Innovates to the Project before Alberta Innovates will advance funds.

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Documents

albertainnovates.ca · Web viewThis must include: income statement, balance sheet, statement of cash flows, and statement of retained earnings. If year-end is greater than 3 months