SEC Company Response from CASSAVA SCIENCES INC (FLNA) (CIK 0001069530) (FLNA) — Dec 4, 2009
CASSAVA SCIENCES INC (FLNA) (CIK 0001069530)
Date: Dec. 4, 2009 · CIK: 0001069530 · Accession: 0001193125-09-247697
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 000-29959
Referenced dates: November 9, 2009
Letter
Correspondence
December 4, 2009
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention:
Nu Ri Jung
Suzanne Hayes
Jeffrey P. Riedler
Re: Pain Therapeutics, Inc.
Form 10-K filed for the Year Ended December 31, 2008
Filed February 13, 2009
File No. 000-29959
Ladies and Gentlemen:
Pain Therapeutics, Inc. (the “Company”) provides this response to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in the Staff’s letter dated November 9, 2009 (the “Staff Letter”), relating to the above-referenced Form 10-K filed by the Company. In response to the Staff’s comments, we have reproduced below the comments set forth in the Staff Letter and followed each comment with our response. The numbered paragraphs of this letter set forth below correspond to the numbered paragraphs of the Staff Letter. References to “we,” “our” or “us” mean the Company or its advisors, as the context may require.
In addition, as requested by the Staff Letter, please note that the Company hereby acknowledges that:
•
the Company is responsible for the adequacy and accuracy of the disclosure in the filings;
•
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filings; and
•
the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Form 10-K, filed 02/13/2009
Item 1. Business, page 2
Intellectual Property, page 5
COMMENT 1: Please identify all of your material patents and all the material patents you license from third parties. Additionally, disclose your product candidates that are dependent on each patent and disclose when each patent expires.
U.S. Securities and Exchange Commission
December 4, 2009
Page
RESPONSE: Our material patents and all the material patents we license from third parties include the following:
•
For Remoxy and our other abuse resistant product candidates, we have licensed from Durect Corporation U.S. Patent 5,747,058, titled “High Viscosity Liquid Controlled Delivery System.” Such patent expires in June 2015.
•
For melanoma, we have licensed from Albert Einstein College of Medicine U.S. Patent No. 7,402,385, titled “Radiolabled Anti-Melanin Antibodies and Peptides for Treatment of Melanoma.” Such patent expires in April 2024.
•
For hemophilia, we have licensed from Poetic Genetics, LLC U.S. Patent No. 7,361,641, titled “Methods and Compositions for Genomic Modification.” Such patent expires in August 2019.
Other patents have published but not issued and other patent applications are pending.
Strategic Alliance with King Pharmaceuticals, Inc., page 5
COMMENT 2: Please revise your disclosure regarding the collaboration agreement and the license agreement with King to disclose when the latest to expire patent is scheduled to expire.
RESPONSE: We propose to revise the last paragraph under the heading “Strategic Alliance with King Pharmaceuticals, Inc.” to include the requested disclosure as follows:
“The collaboration agreement continues until the later of the expiration of any patent rights licensed under the license agreement or developed under the collaboration agreement and the expiration of all periods of market exclusivity with respect to Remoxy and other abuse-resistant opioid drug candidates being developed under the strategic alliance. Currently, the last to expire issued patent covered by such arrangement expires in June 2016; however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We and King can terminate the collaboration agreement under certain circumstances, including material breach and insolvency. Our license agreement with King terminates at the time that the collaboration agreement terminates.”
We propose to include this revised disclosure in our next Annual Report on Form 10-K filed for the fiscal year ending December 31, 2009 (the “Next 10-K”).
Formulation Agreement with Durect Corporation, page 6
COMMENT 3: Please revise your disclosure to disclose all the material terms of this agreement, including, but not limited to, amounts paid to date, aggregate potential milestone payments, the range of potential royalty payments (i.e. “low single digits” or “high single digits”), and term and termination provisions.
U.S. Securities and Exchange Commission
December 4, 2009
Page
RESPONSE: We propose to revise the disclosure under the heading “Formulation Agreement with Durect Corporation” to include the requested disclosure as follows:
“We have an exclusive, worldwide Development and License Agreement, or the Durect Agreement, with Durect Corporation, or Durect, to use a patented technology that forms the basis for a number of oral gel-cap drug candidates, including Remoxy. We reimburse Durect for formulation and related work, and make milestone payments based on the achievement of certain technical, clinical or regulatory milestones. Aggregate payments to Durect from the inception of the Durect Agreement to December 31, 2008 were approximately $34.1 million. We paid Durect $1.0 million in upfront payments under the Durect Agreement and $1.7 million in milestones for achievement of certain clinical and regulatory milestones. We could pay up to another $7.6 million of potential milestone payments under the Durect Agreement following achievement of certain clinical and regulatory milestones. We have sub-licensed to King certain rights to develop and to commercialize Remoxy and certain other opioid drugs formulated in part with technology we licensed from Durect. King controls preclinical, clinical, commercial manufacturing and sales and marketing activities for Remoxy and we control all of the preclinical, clinical, commercial manufacturing and sales and marketing activities the other abuse-resistant opioid painkillers. King is obligated to reimburse us for all expenses for formulation and related work and for milestone payments we incur under our agreement with Durect.
We also are obligated to pay Durect royalties on any related drug sales. Royalties on sales of products licensed under our agreement with Durect range from 6.0% to 11.5%, depending on the level of sales of licensed products in a given calendar year. In turn, King is obligated to reimburse us for all royalty expenses we incur under the agreement with Durect for product sales under our strategic allicance with King. Durect is obligated to supply King with certain components of Remoxy and other abuse-resistant opioid painkillers pursuant to a commercial supply agreement between King and Durect.
The Durect Agreement terminates on a country-by-country basis upon the later of the expiration of the last to expire of the patents licensed under such agreement or a certain number of years following first commercial sale in such country. Currently, the last to expire patent covered by such agreement expires in June 2016: however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We can terminate the Durect Agreement with notice to Durect and we and Durect can terminate such agreement under certain circumstances, including material breach and insolvency.
Under our license agreement with King, we are obligated not to amend or terminate our agreement with Durect if an amendment or termination would alter the rights or obligations of King under our collaboration agreement or license agreement with King.”
We propose to include this revised disclosure in the Next 10-K. The figures given for payments to Durect Corporation in the above proposed language are as of December 31, 2008, but such figures will be updated to December 31, 2009 in the corresponding disclosure we provide in the Next 10-K.
License of Technology from Albert Einstein College of Medicine, page 6
COMMENT 4: Please provide a more specific description of the technology you license from Albert Einstein College of Medicine and identify your product candidates that are dependent on this technology. Additionally, file the agreement as an exhibit and disclose all the material terms of this agreement, including but not limited to quantify the payments made to date, aggregate potential milestone payments, the range of royalty payments (i.e. “low single digits” or “high single digits”), and term and termination provisions. If you believe you are no longer substantially dependent on this agreement, please provide us with an analysis supporting you determination.
U.S. Securities and Exchange Commission
December 4, 2009
Page
RESPONSE: We propose to revise the disclosure under the heading “License of Technology from Albert Einstein College of Medicine” to include the requested disclosure as follows:
“We have licensed certain technology, including technology that we use in our monoclonal antibody program for the treatment of metastatic melanoma, from Albert Einstein College of Medicine, or AECOM, pursuant to a License Agreement, or AECOM Agreement. Under the AECOM Agreement, we have a worldwide exclusive license to the technology underlying the AECOM Agreement and all intellectual property rights arising from such technology. The AECOM Agreement requires us to pay AECOM up to $8 million in milestone payments, based on certain clinical development and commercial milestones, and royalties of 4% based on sales of licensed products. If a product utilizing technology licensed under the AECOM Agreement is combined with a drug or other substance for which we are paying an additional royalty, the royalty that we pay to AECOM will be reduced by up to one-half based on the amount of such additional royalty. In connection with the AECOM Agreement, we also issued a warrant to purchase up to 150,000 shares of our common stock at an exercise price of $6.77 per share, with vesting subject to certain commercial milestones. This warrant expired unvested in January 2010. Aggregate payments to AECOM from the inception of the AECOM Agreement to December 31, 2008 were approximately $1.3 million, inclusive of an up-front payment of $200,000. We have not yet made any milestone payments to AECOM under this agreement.
The AECOM Agreement terminates on a country-by-country basis when our obligation to pay royalties ceases. All royalty obligations will cease upon the expiration of the last to expire patent covered by the agreement. Currently, the last to expire patent covered by such agreement expires in April 2024; however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We can terminate this license anytime and we and AECOM can terminate under certain circumstances, including material breach and insolvency.
AECOM originally received grants from the U.S. federal government to research some of the technology that we license. The terms of these grants provide the U.S. federal government with a non-exclusive, non-transferable paid-up license to practice inventions made with federal funds. Thus, our licenses are non-exclusive to the extent of the U.S. federal government’s license. If the U.S. federal government exercises its rights under this license, it could make use of the same technology that we license and the size of our potential market could thereby be reduced.”
We propose to include this revised disclosure in the Next 10-K. The figures given for payments to the Albert Einstein College of Medicine (“AECOM”) in the above proposed language are as of December 31, 2008, but such figures will be updated to December 31, 2009 in the corresponding disclosure we provide in the Next 10-K.
We do not believe that our business is substantially dependent on the License Agreement with AECOM (the “AECOM Agreement”) within the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K, and, as a result, have not filed such agreement with our periodic reports with the Commission. The technology associated with the AECOM Agreement is currently in the very early stages of research and
U.S. Securities and Exchange Commission
December 4, 2009
Page
development, having completed enrollment in only one Phase I clinical trial outside the U.S. and remaining subject to ongoing pre-clinical investigation. As a result, we do not yet receive any revenues from products utilizing this technology, and our ability to identify, develop and commercialize products covered by the AECOM Agreement, or generate revenue therefrom, is subject to substantial risk and not currently ascertainable. Moreover, we have a pipeline of other development programs and product candidates that we are pursuing, and our business is therefore not dependent on the success of any development candidates we may identify under the AECOM Agreement technology.
License of Technology from Poetic Genetics, LLC, page 7
COMMENT 5: Please revise your disclosure to provide a description of all the material terms of the license agreement with Poetic, including, not limited to payments made to date and term and termination provisions. In addition, please file a copy of the agreement as an exhibit. Alternatively, please provide us with a detailed analysis which supports your conclusion that you are not required to file this agreement pursuant to Item 601(b)(10)(ii)(B) of Regulation S-K.
RESPONSE: We propose to revise the disclosure under the heading “License of Technology from Poetic Genetics, LLC” to include the requested disclosure as follows:
“We have licensed novel gene integration technology from Poetic pursuant to a License Agreement with Poetic, or the Poetic License. We have worldwide commercial rights and all intellectual property rights arising from the technology subject to the Poetic License in all indications in hemophilia and pain management. In connection with the Poetic License, we paid Poetic a $10,000 upfront fee and also issued a warrant to purchase up to 300,000 shares of our common stock at an exercise price of $8.86 per share that does not vest until certain commercialization milestones are met with respect to products relying on technology licensed under the agreement. This warrant is not currently vested and terminates in February 2027. Under the Poetic License, we are also obliged to pay Poetic milestone payments of up to $4 million in the aggregate, based on clinical and regulatory progress, and a royalty on net sales in the mid-single digit range. Other than the up-front payment, we have not to date made any other cash payments to Poetic under this agreement.
The Poetic License terminates on a country-by-country basis on the expiration of the last patent licensed under the agreement or, if there is no valid claim under a licensed patent, seven years from the first commercial sale of a licensed product. Currently, the last to expire patent covered by such agreement expires in August 2019; however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. The Poetic License is also terminable by either us or Poetic in the event of a material breach by the other party.”
We propose to include this revised disclosure in the Next 10-K.
We do not believe that our business is substantially dependent on the License Agreement with Poetic Genetics, LLC (the “Poetic License”) within the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K, and, as a result, have not filed such agreement with our periodic reports with the Commission. The technology associated with the Poetic License is currently in the very early stages of research, and is currently being investigated in pre-clinical
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filename1.htm
Correspondence
December 4, 2009
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention:
Nu Ri Jung
Suzanne Hayes
Jeffrey P. Riedler
Re:
Pain Therapeutics, Inc.
Form 10-K filed for the Year Ended December 31, 2008
Filed February 13, 2009
File No. 000-29959
Ladies and Gentlemen:
Pain Therapeutics, Inc. (the “Company”) provides this response to the
comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in the Staff’s letter dated November 9, 2009 (the “Staff Letter”), relating to
the above-referenced Form 10-K filed by the Company. In response to the Staff’s comments, we have reproduced below the comments set forth in the Staff Letter and followed each comment with our response. The numbered paragraphs of this letter
set forth below correspond to the numbered paragraphs of the Staff Letter. References to “we,” “our” or “us” mean the Company or its advisors, as the context may require.
In addition, as requested by the Staff Letter, please note that the Company hereby acknowledges that:
•
the Company is responsible for the adequacy and accuracy of the disclosure in the filings;
•
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the
filings; and
•
the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of
the United States.
Form 10-K, filed 02/13/2009
Item 1. Business, page 2
Intellectual Property, page 5
COMMENT 1: Please identify all of your material
patents and all the material patents you license from third parties. Additionally, disclose your product candidates that are dependent on each patent and disclose when each patent expires.
U.S. Securities and Exchange Commission
December 4, 2009
Page
2
RESPONSE: Our material patents and all the material patents we license from third parties include the following:
•
For Remoxy and our other abuse resistant product candidates, we have licensed from Durect Corporation U.S. Patent 5,747,058, titled “High
Viscosity Liquid Controlled Delivery System.” Such patent expires in June 2015.
•
For melanoma, we have licensed from Albert Einstein College of Medicine U.S. Patent No. 7,402,385, titled “Radiolabled Anti-Melanin
Antibodies and Peptides for Treatment of Melanoma.” Such patent expires in April 2024.
•
For hemophilia, we have licensed from Poetic Genetics, LLC U.S. Patent No. 7,361,641, titled “Methods and Compositions for Genomic
Modification.” Such patent expires in August 2019.
Other patents have published but not issued and
other patent applications are pending.
Strategic Alliance with King Pharmaceuticals, Inc., page 5
COMMENT 2: Please revise your disclosure regarding the collaboration agreement and the license agreement with King to
disclose when the latest to expire patent is scheduled to expire.
RESPONSE: We propose to revise the last
paragraph under the heading “Strategic Alliance with King Pharmaceuticals, Inc.” to include the requested disclosure as follows:
“The collaboration agreement continues until the later of the expiration of any patent rights licensed under the license agreement or developed under the collaboration agreement and the expiration of
all periods of market exclusivity with respect to Remoxy and other abuse-resistant opioid drug candidates being developed under the strategic alliance. Currently, the last to expire issued patent covered by such arrangement expires in June 2016;
however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We and King can terminate the collaboration agreement under certain circumstances, including material breach and
insolvency. Our license agreement with King terminates at the time that the collaboration agreement terminates.”
We
propose to include this revised disclosure in our next Annual Report on Form 10-K filed for the fiscal year ending December 31, 2009 (the “Next 10-K”).
Formulation Agreement with Durect Corporation, page 6
COMMENT 3: Please revise your disclosure to disclose all the material terms of this agreement, including, but not limited to, amounts paid to date, aggregate potential milestone payments, the range of potential royalty
payments (i.e. “low single digits” or “high single digits”), and term and termination provisions.
U.S. Securities and Exchange Commission
December 4, 2009
Page
3
RESPONSE: We propose to revise the disclosure under the heading “Formulation Agreement with Durect Corporation” to include the requested disclosure as follows:
“We have an exclusive, worldwide Development and License Agreement, or the Durect Agreement, with Durect Corporation, or
Durect, to use a patented technology that forms the basis for a number of oral gel-cap drug candidates, including Remoxy. We reimburse Durect for formulation and related work, and make milestone payments based on the achievement of certain
technical, clinical or regulatory milestones. Aggregate payments to Durect from the inception of the Durect Agreement to December 31, 2008 were approximately $34.1 million. We paid Durect $1.0 million in upfront payments under the Durect
Agreement and $1.7 million in milestones for achievement of certain clinical and regulatory milestones. We could pay up to another $7.6 million of potential milestone payments under the Durect Agreement following achievement of certain clinical and
regulatory milestones. We have sub-licensed to King certain rights to develop and to commercialize Remoxy and certain other opioid drugs formulated in part with technology we licensed from Durect. King controls preclinical, clinical, commercial
manufacturing and sales and marketing activities for Remoxy and we control all of the preclinical, clinical, commercial manufacturing and sales and marketing activities the other abuse-resistant opioid painkillers. King is obligated to reimburse us
for all expenses for formulation and related work and for milestone payments we incur under our agreement with Durect.
We also are obligated to pay Durect royalties on any related drug sales. Royalties on sales of products licensed under our agreement with Durect range from 6.0% to 11.5%, depending on the level of sales of licensed products in a given
calendar year. In turn, King is obligated to reimburse us for all royalty expenses we incur under the agreement with Durect for product sales under our strategic allicance with King. Durect is obligated to supply King with certain components of
Remoxy and other abuse-resistant opioid painkillers pursuant to a commercial supply agreement between King and Durect.
The Durect Agreement terminates on a country-by-country basis upon the later of the expiration of the last to expire of the patents licensed under such agreement or a certain number of years following first commercial sale in such country.
Currently, the last to expire patent covered by such agreement expires in June 2016: however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We can terminate the Durect
Agreement with notice to Durect and we and Durect can terminate such agreement under certain circumstances, including material breach and insolvency.
Under our license agreement with King, we are obligated not to amend or terminate our agreement with Durect if an amendment or termination would alter the rights or obligations of King under our
collaboration agreement or license agreement with King.”
We propose to include this revised disclosure in the Next 10-K.
The figures given for payments to Durect Corporation in the above proposed language are as of December 31, 2008, but such figures will be updated to December 31, 2009 in the corresponding disclosure we provide in the Next 10-K.
License of Technology from Albert Einstein College of Medicine, page 6
COMMENT 4: Please provide a more specific description of the technology you license from Albert Einstein College of Medicine
and identify your product candidates that are dependent on this technology. Additionally, file the agreement as an exhibit and disclose all the material terms of this agreement, including but not limited to quantify the payments made to date,
aggregate potential milestone payments, the range of royalty payments (i.e. “low single digits” or “high single digits”), and term and termination provisions. If you believe you are no longer substantially dependent on
this agreement, please provide us with an analysis supporting you determination.
U.S. Securities and Exchange Commission
December 4, 2009
Page
4
RESPONSE: We propose to revise the disclosure under the heading “License of Technology from Albert Einstein College of Medicine” to include the requested disclosure as follows:
“We have licensed certain technology, including technology that we use in our monoclonal antibody program for the
treatment of metastatic melanoma, from Albert Einstein College of Medicine, or AECOM, pursuant to a License Agreement, or AECOM Agreement. Under the AECOM Agreement, we have a worldwide exclusive license to the technology underlying the AECOM
Agreement and all intellectual property rights arising from such technology. The AECOM Agreement requires us to pay AECOM up to $8 million in milestone payments, based on certain clinical development and commercial milestones, and royalties of 4%
based on sales of licensed products. If a product utilizing technology licensed under the AECOM Agreement is combined with a drug or other substance for which we are paying an additional royalty, the royalty that we pay to AECOM will be reduced by
up to one-half based on the amount of such additional royalty. In connection with the AECOM Agreement, we also issued a warrant to purchase up to 150,000 shares of our common stock at an exercise price of $6.77 per share, with vesting subject to
certain commercial milestones. This warrant expired unvested in January 2010. Aggregate payments to AECOM from the inception of the AECOM Agreement to December 31, 2008 were approximately $1.3 million, inclusive of an up-front payment of
$200,000. We have not yet made any milestone payments to AECOM under this agreement.
The AECOM Agreement
terminates on a country-by-country basis when our obligation to pay royalties ceases. All royalty obligations will cease upon the expiration of the last to expire patent covered by the agreement. Currently, the last to expire patent covered by such
agreement expires in April 2024; however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We can terminate this license anytime and we and AECOM can terminate under certain
circumstances, including material breach and insolvency.
AECOM originally received grants from the U.S.
federal government to research some of the technology that we license. The terms of these grants provide the U.S. federal government with a non-exclusive, non-transferable paid-up license to practice inventions made with federal funds. Thus, our
licenses are non-exclusive to the extent of the U.S. federal government’s license. If the U.S. federal government exercises its rights under this license, it could make use of the same technology that we license and the size of our potential
market could thereby be reduced.”
We propose to include this revised disclosure in the Next 10-K. The figures given for
payments to the Albert Einstein College of Medicine (“AECOM”) in the above proposed language are as of December 31, 2008, but such figures will be updated to December 31, 2009 in the corresponding disclosure we provide in the
Next 10-K.
We do not believe that our business is substantially dependent on the License Agreement with AECOM (the
“AECOM Agreement”) within the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K, and, as a result, have not filed such agreement with our periodic reports with the Commission. The technology associated with the AECOM Agreement is
currently in the very early stages of research and
U.S. Securities and Exchange Commission
December 4, 2009
Page
5
development, having completed enrollment in only one Phase I clinical trial outside the U.S. and remaining subject to ongoing pre-clinical investigation. As a result, we do not yet receive any
revenues from products utilizing this technology, and our ability to identify, develop and commercialize products covered by the AECOM Agreement, or generate revenue therefrom, is subject to substantial risk and not currently ascertainable.
Moreover, we have a pipeline of other development programs and product candidates that we are pursuing, and our business is therefore not dependent on the success of any development candidates we may identify under the AECOM Agreement technology.
License of Technology from Poetic Genetics, LLC, page 7
COMMENT 5: Please revise your disclosure to provide a description of all the material terms of the license agreement with
Poetic, including, not limited to payments made to date and term and termination provisions. In addition, please file a copy of the agreement as an exhibit. Alternatively, please provide us with a detailed analysis which supports your conclusion
that you are not required to file this agreement pursuant to Item 601(b)(10)(ii)(B) of Regulation S-K.
RESPONSE: We propose to revise the disclosure under the heading “License of Technology from Poetic Genetics, LLC” to include the requested disclosure as follows:
“We have licensed novel gene integration technology from Poetic pursuant to a License Agreement with Poetic, or the
Poetic License. We have worldwide commercial rights and all intellectual property rights arising from the technology subject to the Poetic License in all indications in hemophilia and pain management. In connection with the Poetic License, we paid
Poetic a $10,000 upfront fee and also issued a warrant to purchase up to 300,000 shares of our common stock at an exercise price of $8.86 per share that does not vest until certain commercialization milestones are met with respect to products
relying on technology licensed under the agreement. This warrant is not currently vested and terminates in February 2027. Under the Poetic License, we are also obliged to pay Poetic milestone payments of up to $4 million in the aggregate, based on
clinical and regulatory progress, and a royalty on net sales in the mid-single digit range. Other than the up-front payment, we have not to date made any other cash payments to Poetic under this agreement.
The Poetic License terminates on a country-by-country basis on the expiration of the last patent licensed under the agreement
or, if there is no valid claim under a licensed patent, seven years from the first commercial sale of a licensed product. Currently, the last to expire patent covered by such agreement expires in August 2019; however, we expect such date may be
extended by the issuance of any additional patents pursuant to pending patent applications. The Poetic License is also terminable by either us or Poetic in the event of a material breach by the other party.”
We propose to include this revised disclosure in the Next 10-K.
We do not believe that our business is substantially dependent on the License Agreement with Poetic Genetics, LLC (the “Poetic
License”) within the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K, and, as a result, have not filed such agreement with our periodic reports with the Commission. The technology associated with the Poetic License is currently in the
very early stages of research, and is currently being investigated in pre-clinical