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SEC Company Response from CNBX Pharmaceuticals (CNBX) — May 28, 2015

CNBX Pharmaceuticals Inc.
Date: May 28, 2015 · CIK: 0001343009 · Accession: 0001019687-15-002175

AI Filing Summary & Sentiment

File numbers found in text: 000-52403

Date
December 15, 2014
Author
Not clearly detected
Form
CORRESP
Company
CNBX Pharmaceuticals Inc.

Letter

Re: Cannabics Pharmaceuticals Inc. Form 10-K for the Fiscal Year Ended August 31, 2014 Filed December 15, 2014 File No. 000-52403

Dear Ms. Marlowe,

We are in receipt of your letter dated May 5th, 2015 regarding Cannabics Pharmaceuticals Inc. and the aforementioned filing. Below please find our respective responses:

1. Form 10-K for the Fiscal Year Ended August 31, 2014

Item 1. Description of Business, page 1

Regulations, page 7

We note your response to comment 1 and we partially reissue the comment. Please reconcile the disclosure in this section that you license your proprietary technology with the disclosure on page 6 that you are preparing to launch your line of Cannabics SR products in eligible states in the U.S. The disclosure on page 6 and elsewhere in the report reflects you have a line of products, as opposed to solely licensing your technology to other companies who would then develop the products. Please reconcile.

RESPONSE –

After closer review, the issue is more clearly defined. Our previous response to this Comment was accurate in that the issuer only licenses its technology. However, it does appear incongruent with the sentence on page 6 that the company “is now preparing to launch its line of CANNABICS SR products in eligible states”. In fact the company is not, and has never prepared to launch “its line” of products; and herein lays the error. Rather the company has a relationship with Mountain High LLC, which is preparing their product, utilizing our technology for the slow release capsules. The Company’s grant of IP rights relates only to the formulation of long lasting capsules. Mountain High LLC is the sole producer, and it is their product, under their label which they alone distribute. The Company has no plans (or interest) in releasing any product under its own name or label. Since this 10-K was drafted much earlier than the actual expected release date, I, as the draftsman of said 10-K, was somewhat inarticulate in writing the terms “Its line of Cannabics SR products”. It would be more accurate and the company proposes to instead supplement with “The Company’s strategic partner is now preparing to launch its new product utilizing the company’s technology in their slow release capsules”.

2. We also note your response to comment 1 that the company does not make any medical claims about its products and as such needs no specific FDA approval. However, we note the references to your product Cannabics SR as a “long-acting medical cannabis capsule … indicated initially as a palliative therapy for cancer patients” on page 2. We even note the reference to this as a “medical product” on page 9 of the Form 10-Q for the fiscal quarter ended February 28, 2015. Please reconcile and provide a more detailed discussion of the U.S. regulation of your proposed product.

RESPONSE –

It is interesting that only upon reflection and discussion of your comments did the management and scientists begin to clarify the bifurcated nature of the company. Much as we had “blurred the lines” in our previous answer (supra) regarding “the Company’s line of products” (which is not so); hereto division & delineation between the government licensed scientific laboratory work in conjunction with the Technion Institute which is unfolding in Israel on the one hand; and the making of any medical claims inside of America are wholly separate.

Firstly, the company’s “claims” relate only to the efficacy of the slow release formulation and observations in Israel alone. While it is common knowledge in all countries that cannabis helps with many of the effects of chemotherapy common in cancer patients, and that is the focus of the ongoing studies in Israel, neither the issuer nor Mountain High LLC make any specific medical claim whatsoever with regards to Mountain High’s capsule produced with the company’s technology. Moreover, Mountain High LLC, beyond its own state licensing issues which would not allow such claims; is specifically contractually prohibited from making any medical claims as to its product.

It is readily acknowledged (as you noted) that several medical claims appeared in our filings, though not as a product which we produce. As previously addressed, the IP which is licensed is solely for the “Slow Release” of carrageenan , is 100% natural and has no synthetic ingredients, & is considered as “GRAS” (Generally Regarded As Safe), and as such needs no specific FDA approval. Moreover, under the current legal regimen within the US, it is impossible for Cannabics Pharmaceuticals Inc. to actually attempt to produce its “own” capsules, with or without any attending medical claims.

The legal regimen within the US with regard to Cannabis is admittedly confusing at best. While we all know that Marijuana is still considered a Class 1 Scheduled drug under the FDA, it is legal, regulated & licensed within the state of Colorado.

It is not by accident that the company’s sole licensee to date is in Colorado, the one US state with a highly regulated licensing structure. Mountain High LLC is in fact the second largest infused product manufacturer in Colorado. In fact, the oddity is that it was the state of Colorado, in setting up their licensing regimen which statutorily defined licensing for an “infused product” as a “Medical Marijuana Infused Product”.

“Medical Marijuana-Infused Product” means a product infused with Medical Marijuana that is intended for use or consumption other than by smoking, including but not limited to edible product, ointments, and tinctures. Such products shall not be considered a food or drug for purposes of the “Colorado Food and Drug Act,” (part 4 of Article 5 of Title 25, C.R.S.).

Mountain High LLC holds a valid “Medical Marijuana-Infused Products Manufacturer” License, meaning they are licensed pursuant to the Medical Code to operate a medical infused product business as described in section 12-43.3-404, C.R.S. As the company can only liaise with a validly licensed manufacturer, under the Colorado Statute, it can only be a “Medical Marijuana-Infused Products Manufacturer”, so by legal regimen we are defacto under the Medical sector, and not under “food or drugs” per the CRS itself. We do not, have not and will not enter into any contractual agreements with any partner outside the state of Colorado at this time specifically because of their strict licensing & quality control agenda, which is to the Company’s advantage.

As such, the company is really two steps removed from FDA aegis; 1) we do not manufacture, distribute, dispense, or possess any controlled substances, including cannabis or cannabis-based preparations. 2) Mountain High LLC, is specifically licensed by the state as a Medical Marijuana Infused Products Manufacturer. We provide them with absolutely nothing tangible nor physical in any form, merely the IP rights for a carrageenan based time-released capsule technology, not the elements which fill it. As such, we are not under the FDA regulatory regime.

While the company is not under the aegis of the FDA, there is the very real possibility that we may approach the FDA in the next year as our technology emanating from our joint collaboration with the Technion Institute is far surpassing the results we had expected at this point. While we have no obligation to do so at this point, the purpose of such an application would be to apply under the US FDA’s “Fast Track” program as a “Breakthrough Therapy”.

Section 506(a) of the FD&C Act provides for designation of a drug as a breakthrough therapy “. . . if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” It is important to recognize that the standard for breakthrough therapy designation is not the same as the standard for drug approval. The clinical evidence needed to support breakthrough designation is preliminary. In contrast, as is the case for all drugs, FDA will review the full data submitted to support approval of drugs designated as breakthrough therapies to determine whether the drugs are safe and effective for their intended use.

Section 506(a)(3)(B)(iv) of the FD&C Act, as amended by section 902 of FDASIA, provides that the FDA shall assign a cross-disciplinary project lead to the review team during the review of the development programs for breakthrough therapy-designated drugs, which would align quite well with our relationship with the Technion Institute.

Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need.

There are several prerequisites for FDA designation under this pathway, all of which the Company believes it currently meets; namely -

Serious Condition: Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

Unmet Medical Need: For a drug to address an unmet medical need, the drug must be developed as a treatment or preventative measure for a disease that does not have a current therapy. The type of information necessary to demonstrate unmet medical need varies with the stage of drug development: early in development, nonclinical data, mechanistic rationale, or pharmacologic data will suffice; later in development, clinical data should be utilized. If there are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as:

· Showing superior effectiveness

· Avoiding serious side effects of an available treatment

· Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome

· Decreasing a clinically significant toxicity of an available treatment

· Addressing an expected public health need

It is expected that the Company’s application, in light of the focus on cancer and the exceptional lack of negative side effects, bring it squarely within the ambits of the FDA’s Fast Track for “Breakthrough Therapy”.

3. We note your proposed revisions regarding the risks to the company. We note that with regard to U.S. law governing the sale of marijuana, you state that the company does not manufacture, distribute, dispense, or possess any controlled substances. Please revise your disclosure to alert investors that your operations could be deemed to facilitate the selling or distribution of marijuana in violation of the federal Controlled Substances Act, or to constitute aiding or abetting, or being an accessory to, a violation of that Act.

RESPONSE –

With all due respect to Ms. Marlow, Ms. Jenkins as well as the Commission, this proposed revision is simply ludicrous and the issuer respectfully disagrees with the legal rationale. First and foremost, it is not for the Corporate Finance Division of the SEC to suggest that this issuer “could be deemed” in violation of Federal Narcotics laws; rather, were that a concern at all, it would be one for the Department of Justice, and under their purview alone.

Secondly, it is an absolute legal and practical impossibility as one of the very underlying terms of licensure by the Israeli Ministry of Health, which is quite stringent, is that there is no criminal activity on the part of the licensee. The idea that this same Company would now publicly state that may be deemed to “facilitate selling or distribution in violation of the Controlled Substances Act” would likely force immediate revocation of its license by the Israeli Ministry of Health. The issuer submits that it has met and qualified for all rigorous Israeli Ministry of Health rules and regulations, and was specifically licensed by them. It is incongruous that the Corporate Finance Division can simply take it upon itself to wade into the licensing authority of a foreign government and by caprice destroy that right which was given by the government licensing authority.

This issue is significant, and not limited to this Company alone. Israel right now is known as the most advanced nation at this point in its scientific studies of Cannabinoids, and such a proposed revision immediately eviscerates the licensure of every single company the Israeli Health Ministry has duly licensed.

Beyond this, and after consultation with several colleagues in the Federal Bar, it is my very strong and objective believe that such a proposed revision simply is not comportant with the definitions necessary to even allege such behavior.

The definition of Section 18 USC 2(a) (“Aiding and Abetting”) means assisting in the commission of someone else’s crime. This demands that a defendant embrace the crime of another and consciously do some act to contribute to its success.

See generally Rosemond v. United States, 134 S.Ct. at 1246; United States v. Lyons, 740 F.3d 702, 715 (1 Cir. 2014) (“An aider and abettor is punishable as a principal if, first, someone else actually committed the offense and, second, the aider and abettor became associated with the endeavor and took part in it intending to ensure its success. The central requirement of the second element is a showing that the defendant consciously shared the principal’s knowledge of the underlying criminal act and intended to help the principal.

Mere association between the principal, and the aider and abettor is insufficient. Id. Mere participation is not enough proof that a defendant intentionally assisted in the ventures illegal purpose. United States v. Ramos-Rascon, 8 F.3d 704, 711 (9th Cir. 1993).

In order to prove a case under § 2 of 18 USC, three elements must exist:

1. The individual associated with the criminal endeavor,

2. The individual knowingly participated in the endeavor, and

3. The individual sought by his or her actions to make the endeavor succeed.

Clearly the licensing of Intellectual Property does not fall within the ambit of meaningful activity necessary to “assist in the commission of a crime” – both I would note are active verbs. Moreover – and by far more importantly, the manufacturer’s activity in the state of Colorado is legal and it holds license to do so. Per the “Cole Memo”; FinCen Release #FIN-2014-G001; US DOJ Memo to all States Attorneys: “Guidance Regarding Marijuana Enforcement” that state granted license ameliorates their activity per the CSA. The idea that one could then jump from their activity (which is a pre-requisite for “Aiding & Abetting”) to adhere criminal enterprise liability to scientists who license IP is simply too far.

While Aiding & Abetting can be an inchoate crime, “Distribute” is by definition even more active, and thus less tenable.

Per 21 U.S. Code § 802 (11) “The term “distribute” means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term “distributor” means a person who so delivers a controlled substance or a listed chemical.” This is from the very “Definition of Terms” of the CSA.

21 U.S.C. § 841(A)(1) DISTRIBUTION OF A CONTROLLED SUBSTANCE – ELEMENTS - Section 841 prohibits knowing or intentional distribution of a controlled substance. See, United States v. Graham, 315 F.3d 777, 781 (7th Cir. 2003).

Were the Justice Department to actually bring charges against the company,

Show Raw Text
CORRESP
1
filename1.htm

#3 BETHESDA METRO CENTRE

SUITE 700

BETHESDA, MD 20814

---------

Tel (877) 424-2429

Cannabics.com

May 27th, 2015

US Securities & Exchange Commission

Corporate Finance Division

Washington, DC 20549

Attn: Ms. Julie Marlowe

Re: Cannabics Pharmaceuticals Inc.

Form 10-K for the Fiscal Year Ended August
31, 2014

Filed December 15, 2014

File No. 000-52403

Dear Ms. Marlowe,

We are in receipt of
your letter dated May 5th, 2015 regarding Cannabics Pharmaceuticals Inc. and the aforementioned filing. Below please
find our respective responses:

 1. Form 10-K for the Fiscal Year Ended August 31, 2014

Item 1. Description of Business, page 1

Regulations, page 7

We note your response to comment 1 and we partially
reissue the comment. Please reconcile the disclosure in this section that you license your proprietary technology with the disclosure
on page 6 that you are preparing to launch your line of Cannabics SR products in eligible states in the U.S. The disclosure on
page 6 and elsewhere in the report reflects you have a line of products, as opposed to solely licensing your technology to other
companies who would then develop the products. Please reconcile.

RESPONSE –

After closer review, the issue is more clearly defined.
Our previous response to this Comment was accurate in that the issuer only licenses its technology. However, it does appear incongruent
with the sentence on page 6 that the company “is now preparing to launch its line of CANNABICS SR products
in eligible states”. In fact the company is not, and has never prepared to launch “its line” of products;
and herein lays the error. Rather the company has a relationship with Mountain High LLC, which is preparing their product,
utilizing our technology for the slow release capsules. The Company’s grant of IP rights relates only to the formulation
of long lasting capsules. Mountain High LLC is the sole producer, and it is their product, under their label which they alone distribute.
The Company has no plans (or interest) in releasing any product under its own name or label. Since this 10-K was drafted
much earlier than the actual expected release date, I, as the draftsman of said 10-K, was somewhat inarticulate in writing the
terms “Its line of Cannabics SR products”. It would be more accurate and the company proposes to instead supplement
with “The Company’s strategic partner is now preparing to launch its new product utilizing the company’s technology
in their slow release capsules”.

 2. We also note your response to comment 1 that the company does not make any medical claims about its products and as such needs
no specific FDA approval. However, we note the references to your product Cannabics SR as a “long-acting medical cannabis
capsule … indicated initially as a palliative therapy for cancer patients” on page 2. We even note the reference to
this as a “medical product” on page 9 of the Form 10-Q for the fiscal quarter ended February 28, 2015. Please reconcile
and provide a more detailed discussion of the U.S. regulation of your proposed product.

RESPONSE –

It is interesting that only upon reflection
and discussion of your comments did the management and scientists begin to clarify the bifurcated nature of the company. Much as
we had “blurred the lines” in our previous answer (supra) regarding “the Company’s line of products”
(which is not so); hereto division & delineation between the government licensed scientific laboratory work in conjunction
with the Technion Institute which is unfolding in Israel on the one hand; and the making of any medical claims inside
of America are wholly separate.

Firstly, the company’s “claims” relate only
to the efficacy of the slow release formulation and observations in Israel alone. While it is common knowledge in all countries
that cannabis helps with many of the effects of chemotherapy common in cancer patients, and that is the focus of the ongoing studies
in Israel, neither the issuer nor Mountain High LLC make any specific medical claim whatsoever with regards to Mountain
High’s capsule produced with the company’s technology. Moreover, Mountain High LLC, beyond its own state licensing
issues which would not allow such claims; is specifically contractually prohibited from making any medical claims as to its product.

It is readily acknowledged (as you noted) that several medical
claims appeared in our filings, though not as a product which we produce. As previously addressed, the IP which is
licensed is solely for the “Slow Release” of carrageenan , is 100% natural and has no synthetic ingredients, &
is considered as “GRAS” (Generally Regarded As Safe), and as such needs no specific FDA approval. Moreover,
under the current legal regimen within the US, it is impossible for Cannabics Pharmaceuticals Inc. to actually attempt to produce
its “own” capsules, with or without any attending medical claims.

    2

The legal regimen within the US with regard to Cannabis is admittedly
confusing at best. While we all know that Marijuana is still considered a Class 1 Scheduled drug under the FDA, it is legal,
regulated & licensed within the state of Colorado.

It is not by accident that the company’s sole licensee
to date is in Colorado, the one US state with a highly regulated licensing structure. Mountain High LLC is in fact the second largest
infused product manufacturer in Colorado. In fact, the oddity is that it was the state of Colorado, in setting up their licensing
regimen which statutorily defined licensing for an “infused product” as a “Medical Marijuana Infused Product”.

“Medical Marijuana-Infused Product”
means a product infused with Medical Marijuana that is intended for use or consumption other than by smoking, including but not
limited to edible product, ointments, and tinctures. Such products shall not be considered a food or drug for purposes of the “Colorado
Food and Drug Act,” (part 4 of Article 5 of Title 25, C.R.S.).

Mountain High LLC holds a valid “Medical Marijuana-Infused
Products Manufacturer” License, meaning they are licensed pursuant to the Medical Code to operate a medical infused product
business as described in section 12-43.3-404, C.R.S. As the company can only liaise with a validly licensed manufacturer,
under the Colorado Statute, it can only be a “Medical Marijuana-Infused Products Manufacturer”, so by legal
regimen we are defacto under the Medical sector, and not under “food or drugs” per the CRS itself. We do not,
have not and will not enter into any contractual agreements with any partner outside the state of Colorado at this time specifically
because of their strict licensing & quality control agenda, which is to the Company’s advantage.

As such, the company is really two steps removed from FDA aegis;
1) we do not manufacture, distribute, dispense, or possess any controlled substances, including cannabis or cannabis-based
preparations. 2) Mountain High LLC, is specifically licensed by the state as a Medical Marijuana Infused Products Manufacturer.
We provide them with absolutely nothing tangible nor physical in any form, merely the IP rights for a carrageenan based time-released
capsule technology, not the elements which fill it. As such, we are not under the FDA regulatory regime.

While the company is not under the aegis of the FDA,
there is the very real possibility that we may approach the FDA in the next year as our technology emanating from our joint collaboration
with the Technion Institute is far surpassing the results we had expected at this point. While we have no obligation to do so
at this point, the purpose of such an application would be to apply under the US FDA’s “Fast Track” program as
a “Breakthrough Therapy”.

Section 506(a) of the FD&C Act provides for designation
of a drug as a breakthrough therapy “. . . if the drug is intended, alone or in combination with 1 or more other drugs, to
treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects
observed early in clinical development.” It is important to recognize that the standard for breakthrough therapy designation
is not the same as the standard for drug approval. The clinical evidence needed to support breakthrough designation is preliminary.
In contrast, as is the case for all drugs, FDA will review the full data submitted to support approval of drugs designated as breakthrough
therapies to determine whether the drugs are safe and effective for their intended use.

    3

Section 506(a)(3)(B)(iv) of the FD&C Act, as amended by
section 902 of FDASIA, provides that the FDA shall assign a cross-disciplinary project lead to the review team during the review
of the development programs for breakthrough therapy-designated drugs, which would align quite well with our relationship with
the Technion Institute.

Fast track designation is designed to aid in the development
and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical
need.

There are several prerequisites for FDA designation under this
pathway, all of which the Company believes it currently meets; namely -

Serious Condition: Determining whether a disease is serious
is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day
functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious
one.

Unmet Medical Need: For a drug to address an unmet medical need,
the drug must be developed as a treatment or preventative measure for a disease that does not have a current therapy. The type
of information necessary to demonstrate unmet medical need varies with the stage of drug development: early in development, nonclinical
data, mechanistic rationale, or pharmacologic data will suffice; later in development, clinical data should be utilized. If there
are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as:

 · Showing superior effectiveness

 · Avoiding serious side effects of an available treatment

 · Improving the diagnosis of a serious disease where early diagnosis
results in an improved outcome

 · Decreasing a clinically significant toxicity of an available treatment

 · Addressing an expected public health need

It is expected that the Company’s application,
in light of the focus on cancer and the exceptional lack of negative side effects, bring it squarely within the ambits of the FDA’s
Fast Track for “Breakthrough Therapy”.

    4

3. We note your proposed revisions regarding the risks to the company. We note that with regard to U.S. law governing the sale
of marijuana, you state that the company does not manufacture, distribute, dispense, or possess any controlled substances. Please
revise your disclosure to alert investors that your operations could be deemed to facilitate the selling or distribution of marijuana
in violation of the federal Controlled Substances Act, or to constitute aiding or abetting, or being an accessory to, a violation
of that Act.

RESPONSE –

With all due respect to Ms. Marlow, Ms. Jenkins as
well as the Commission, this proposed revision is simply ludicrous and the issuer respectfully disagrees with the legal rationale.
First and foremost, it is not for the Corporate Finance Division of the SEC to suggest that this issuer “could be deemed”
in violation of Federal Narcotics laws; rather, were that a concern at all, it would be one for the Department of Justice, and
under their purview alone.

Secondly, it is an absolute legal and practical impossibility
as one of the very underlying terms of licensure by the Israeli Ministry of Health, which is quite stringent, is that there is
no criminal activity on the part of the licensee. The idea that this same Company would now publicly state that may be deemed to
“facilitate selling or distribution in violation of the Controlled Substances Act” would likely force immediate revocation
of its license by the Israeli Ministry of Health. The issuer submits that it has met and qualified for all rigorous Israeli Ministry
of Health rules and regulations, and was specifically licensed by them. It is incongruous that the Corporate Finance Division can
simply take it upon itself to wade into the licensing authority of a foreign government and by caprice destroy that right which
was given by the government licensing authority.

This issue is significant, and
not limited to this Company alone. Israel right now is known as the most advanced nation at this point in its scientific
studies of Cannabinoids, and such a proposed revision immediately eviscerates the licensure of every single company the Israeli
Health Ministry has duly licensed.

Beyond this, and after consultation
with several colleagues in the Federal Bar, it is my very strong and objective believe that such a proposed revision simply is
not comportant with the definitions necessary to even allege such behavior.

The definition of Section 18 USC 2(a) (“Aiding
and Abetting”) means assisting in the commission of someone else’s crime. This demands that a defendant embrace the
crime of another and consciously do some act to contribute to its success.

See generally Rosemond v. United States, 134
S.Ct. at 1246; United States v. Lyons, 740 F.3d 702, 715 (1 Cir. 2014) (“An aider and abettor is punishable as a principal
if, first, someone else actually committed the offense and, second, the aider and abettor became associated with the endeavor and
took part in it intending to ensure its success. The central requirement of the second element is a showing that the defendant
consciously shared the principal’s knowledge of the underlying criminal act and intended to help the principal.

Mere association between the principal, and the aider
and abettor is insufficient. Id. Mere participation is not enough proof that a defendant intentionally assisted in the ventures
illegal purpose. United States v. Ramos-Rascon, 8 F.3d 704, 711 (9th Cir. 1993).

    5

In order to prove a case under § 2 of 18 USC, three elements
must exist:

1. The individual associated with the criminal endeavor,

2. The individual knowingly participated in the endeavor,
and

3. The individual sought by his or her actions to make
the endeavor succeed.

Clearly the licensing of Intellectual Property
does not fall within the ambit of meaningful activity necessary to “assist in the commission of a crime” – both
I would note are active verbs. Moreover – and by far more importantly, the manufacturer’s activity in the state of
Colorado is legal and it holds license to do so. Per the “Cole Memo”; FinCen Release #FIN-2014-G001;
US DOJ Memo to all States Attorneys: “Guidance Regarding Marijuana Enforcement” that state granted license ameliorates
their activity per the CSA. The idea that one could then jump from their activity (which is a pre-requisite
for “Aiding & Abetting”) to adhere criminal enterprise liability to scientists who license IP is simply too far.

While Aiding & Abetting can be an inchoate
crime, “Distribute” is by definition even more active, and thus less tenable.

Per 21 U.S. Code § 802 (11) “The term “distribute”
means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term “distributor”
means a person who so delivers a controlled substance or a listed chemical.” This is from the very “Definition
of Terms” of the CSA.

21 U.S.C. § 841(A)(1) DISTRIBUTION OF A CONTROLLED
SUBSTANCE – ELEMENTS - Section 841 prohibits knowing or intentional distribution of a controlled substance. See, United
States v. Graham, 315 F.3d 777, 781 (7th Cir. 2003).

Were the Justice Department to actually bring charges
against the company,