What changed in this filing

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Item 1A. Risk Factors

2021-11-15 compared with 2021-07-28 · 83 added, 63 removed, 61 unchanged (71% of the section changed)

8 unchanged sentences

rights to develop and commercialize our product candidates are subject to, in part, the terms and conditions of licenses granted to us

rely upon licenses to certain patent rights and proprietary technology from third parties

that are important or necessary to the development of our technology and products, including

technology related to our manufacturing process and our product candidates.

rely upon licenses to certain patent rights and proprietary technology from third parties that are important or necessary to the development

of our technology and products, including technology related to our manufacturing process and our product candidates.

These and other

licenses may not provide exclusive rights to use such intellectual property and technology

in all relevant fields of use and in all territories in which we may wish to develop or commercialize

our technology and products in the future.

As a result, we may not be able to prevent competitors

from developing and commercializing competitive products in territories included in all of

our licenses.

These licenses may also require us to grant back certain rights to licensors

and to pay certain amounts relating to sublicensing patent and other rights under the agreement.

licenses may not provide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories

in which we may wish to develop or commercialize our technology and products in the future.

As a result, we may not be able to prevent

competitors from developing and commercializing competitive products in territories included in all of our licenses.

These licenses may

also require us to grant back certain rights to licensors and to pay certain amounts relating to sublicensing patent and other rights

under the agreement.

our licensors fail to maintain such patents, or lose rights to those patents or patent applications, the rights we have licensed may

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priority of invention of patented technology.

any dispute over in-licensed intellectual property prevents or impairs our ability to maintain our current licensing arrangements on

acceptable terms, we may be unable to successfully commercialize the affected product candidates.

we fail to comply with our obligations under these license agreements, or we are subject to a bankruptcy, the licensor may have the right

to terminate the license, in which event we may not be able to manufacture, or market products covered by the license or may face other

If any dispute over in-licensed intellectual property prevents or impairs our ability to maintain our current licensing arrangements

on acceptable terms, we may be unable to successfully commercialize the affected product candidates.

Termination of these agreements

or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with

less favorable terms or cause us to lose our rights under these agreements, including our rights to important intellectual property or

It is possible that such termination may occur even if we believe that we have complied with our obligations under a license

agreement, if a dispute arises between us and a licensor.

Our license agreement with REGENXBIO had granted us an exclusive worldwide

license (subject to certain non-exclusive rights previously granted for MPS IIIA), with rights to sublicense, to use REGENXBIO’s

NAV AAV9 capsid in gene therapies for treating MPS IIIA, MPS IIIB, CLN1 Disease, and CLN3 Disease.

(Our CLN1 program was sold to Taysha

Gene Therapies in August 2020.) On May 2, 2020, REGENXBIO terminated the license agreement.

On May 25, 2020, we filed an arbitration

claim with the American Arbitration Association (“AAA”) alleging that REGENXBIO materially breached the license agreement

prior to termination and seeking, among other things, a declaration that as a result of REGENXBIO’s material breach, we were not

responsible for payments totaling $28 million (which would otherwise have been due in 2020) plus accrued interest ($6.4 million as of

June 30, 2021 based on invoices received from REGENXBIO).

REGENXBIO disputed our arbitration claim and filed a counterclaim seeking payment

of the $28 million plus interest, which REGENXBIO argued remained due.

An arbitration hearing before a tribunal of three AAA arbitrators

was held on March 8 and March 9, 2021.

On July 13, 2021, the tribunal found in favor of REGENXBIO Inc.

in connection with the parties’

arbitration claims and counterclaims.

Although the tribunal awarded REGENXBIO $28.0 million plus interest, we believe that prior to the

arbitration decision, the two companies had entered into a binding settlement agreement, including $18.0 million payable to REGENXBIO

over a two-year period.

We intend to seek enforcement of the settlement agreement.

It is possible that REGENXBIO may in the future assert

that our proposed products infringe one or more of REGENXBIO’s AAV9 patent claims, and we still may ultimately need a license to

use the AAV9 capsid in our proposed MPS IIIA, MPS IIIB, or CLN3 products, if such a product is commercialized before the expiration of

one or more REGENXBIO patent claims that cover our commercial product.

Absent such a license, if we are found to infringe a valid and

enforceable REGENXBIO AAV9 patent claim before the expiration of a relevant REGENXBIO patent, it is possible that a court may order us

to pay a reasonable royalty to REGENXBIO until relevant patents expire.

Although courts generally impose a reasonable royalty and it

is very unlikely based on the current state of the relevant law that a court would grant a permanent injunction to prevent the launch

of one of our products, it is possible that a court could enjoin us from commercializing our MPS IIIA, MPS IIIB, or CLN3 products until

relevant AAV9 patents expire if the court finds that any harm to REGENXBIO would not be compensable by money damages.

Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having

to negotiate new or reinstated agreements with less favorable terms or cause us to lose our rights under these agreements, including

our rights to important intellectual property or technology.

It is possible that such termination may occur even if we believe that we

have complied with our obligations under a license agreement, if a dispute arises between us and a licensor.

Our license agreement with

REGENXBIO had granted us an exclusive worldwide license (subject to certain non-exclusive rights previously granted for MPS IIIA), with

rights to sublicense, to use REGENXBIO’s NAV AAV9 capsid in gene therapies for treating MPS IIIA, MPS IIIB, CLN1 Disease, and CLN3

(Our CLN1 program was sold to Taysha Gene Therapies in August 2020.) On May 2, 2020, REGENXBIO terminated the license agreement.

On May 25, 2020, we filed an arbitration claim with the American

Arbitration Association (“AAA”) alleging that REGENXBIO materially breached the license agreement prior to termination and

seeking, among other things, a declaration that as a result of REGENXBIO’s material breach, we were not responsible for payments

totaling $28 million (which would otherwise have been due in 2020) plus accrued interest.

REGENXBIO disputed our arbitration claim and

filed a counterclaim seeking payment of the $28 million plus interest, which REGENXBIO argued remained due.

An arbitration hearing before

a tribunal of three AAA arbitrators was held on March 8 and March 9, 2021.

On July 13, 2021, the tribunal found in favor of REGENXBIO

in connection with the parties’ arbitration claims and counterclaims.

The tribunal awarded REGENXBIO $28.0 million plus interest.

On August 9, 2021, we filed a second arbitration claim with the AAA asserting that a settlement had been reached before the tribunal’s

award in the first arbitration was issued.

On September 14, 2021, REGENXBIO filed its answer, a counterclaim seeking attorney fees and

costs, and a request for permission to file a case dispositive motion.

A preliminary hearing was held on November 1, 2021, during which

the AAA Tribunal set timetables for discovery and for REGENXBIO’s filing of its case dispositive motion.

Those timetables were

formalized in a procedural order issued by the Tribunal on November 8, 2021.

Under the schedule set by the Tribunal, REGENXBIO’s

opening brief in support of its case dispositive motion was filed on November 8, 2021, briefing was scheduled to be completed on December

29, 2021, and oral argument was scheduled for January 14, 2022.

REGENXBIO had also filed suit in the New York State Supreme Court Commercial

Division seeking enforcement of the original arbitration award, and we had requested that the Court stay that proceeding until the second

arbitration is complete.

Oral argument on our request for a stay was set for March 10, 2022.

On November 12, 2021, we entered into a

settlement agreement (“Settlement Agreement”) with REGENXBIO to resolve all current disputes between the parties including

the aforementioned AAA arbitration and New York State Court action.

In accordance with the Settlement Agreement, we agreed to pay REGENXBIO

a total of $30 million, payable as follows:

(1) $20 million payable within one business day of the execution of the Settlement Agreement,

(2) $5 million on the first anniversary of the effective date of the Settlement Agreement, and (3) $5 million upon the earlier of:

the third anniversary of the effective date of the Settlement Agreement or (ii) the closing of a Strategic Transaction, as defined in

the Settlement Agreement.

Under the Settlement Agreement’s terms, the prior license agreement between the parties was not reinstituted,

and any future license agreement would need to be negotiated separately and require consideration in addition to the consideration set

forth in the Settlement Agreement.

It is possible that REGENXBIO may in the future assert that our proposed products infringe one

or more of REGENXBIO’s AAV9 patent claims, and we still may ultimately need a license to use the AAV9 capsid in our proposed MPS

IIIA, MPS IIIB, or CLN3 products, if such a product is commercialized before the expiration of one or more REGENXBIO patent claims that

cover our commercial product.

Absent such a license, if we are found to infringe a valid and enforceable REGENXBIO AAV9 patent claim

before the expiration of a relevant REGENXBIO patent, it is possible that a court may order us to pay a reasonable royalty to REGENXBIO

until relevant patents expire.

Although courts generally impose a reasonable royalty and we believe it is very unlikely based on the

current state of the relevant law that a court would grant a permanent injunction to prevent the launch of one of our products, it is

possible that a court could enjoin us from commercializing our MPS IIIA, MPS IIIB, or CLN3 products until relevant AAV9 patents expire

if the court finds that any harm to REGENXBIO would not be compensable by money damages.

to the extent that the research resulting in certain of our licensed patent rights and technology was funded by the U.S.

15 unchanged sentences

Exhibit Index below, which is incorporated by reference herein.

Letter Agreement, dated August 10, 2021, between the Company and Edward Carr.

Principal Executive Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.

2 unchanged sentences

Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

following materials from Abeona’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, formatted in Inline XBRL

(Extensible Business Reporting Language):

(i) Condensed Consolidated Balance Sheets at June 30, 2021 and December 31, 2020, (ii)

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2021 and 2020,

(iii) Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2021 and 2020,

(iv) Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2021 and 2020, and (v) Notes to Condensed

Consolidated Financial Statements.

Pursuant to Item 601(b)(32)(ii) of Regulation S-K, this exhibit shall not be deemed “filed” for purposes of Section 18

of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated

by reference in any filings under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after

the date hereof and irrespective of any general incorporation language in any filing.

following materials from Abeona’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, formatted in Inline

XBRL (Extensible Business Reporting Language):

(i) Condensed Consolidated Balance Sheets at September 30, 2021 and December 31, 2020,

(ii) Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2021

and 2020, (iii) Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30,

2021 and 2020, (iv) Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2021 and 2020, and (v)

Notes to Condensed Consolidated Financial Statements.

Pursuant to Item 601(b)(32)(ii) of Regulation S-K, this exhibit shall not be deemed “filed” for purposes of Section 18 of

the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference

in any filings under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof

and irrespective of any general incorporation language in any filing.

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

1 unchanged sentence

THERAPEUTICS INC.

Michael Amoroso

Vishwas Seshadri

and Chief Executive Officer

Executive Officer)

Accounting Officer

Financial Officer

Financial Officer)

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors