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Msg  50 of 58  at  5/7/2020 6:11:38 AM  by

Dendrimer


License agreement with RegenX

See below for an extract from the Q1 10-Q regarding termination of the license agreement with RegenX for gene therapy vectors for use in treating MPS3A, MPS3B, CLN1 & CLN3. Can anyone come up with an explanation for why ABEO would let this license terminate?  Does this mean the four GTs are now dead?? Will ABEO have to start again with their own AIM vectors?
 
 
On May 2, 2020, our license agreement with REGENXBIO to obtain rights to an exclusive worldwide license (subject to certain non-exclusive rights previously granted for MPS IIIA), with rights to sublicense, to REGENXBIO’s NAV AAV9 vector for gene therapies for treating MPS IIIA, MPS IIIB, CLN1 Disease and CLN3 Disease was terminated. The Company had an $8 million payment due on April 1, 2020 pursuant to such agreement. Prior to the April 1, 2020 deadline, the Company engaged REGENXBIO in discussions in an attempt to renegotiate the financial terms of the agreement, but the parties were unable to reach a mutual understanding that the Company believed would have been favorable for the Company or its programs, and the Company did not make the $8 million payment due by April 1, 2020. On April 17, 2020, REGENXBIO sent the Company a written demand for the $8 million fee, payable within a 15-day cure period after receipt of the demand letter. The license terminated on May 2, 2020, when the 15-day period expired. As a result, the Company no longer has an exclusive worldwide license to REGENXBIO’s NAV AAV9 vector for the development and commercialization of gene therapies for the treatment of MPS IIIA, MPS IIIB, CLN1 Disease and CLN3 Disease.
ITEM 5. OTHER INFORMATION
On November 4, 2018, the Company entered into a license agreement (as amended on November 4, 2019, “Agreement”) with REGENXBIO. Under the Agreement, REGENXBIO granted the Company an exclusive worldwide license to use the NAV AAV9 vector for gene therapies for treating Sanfilippo Syndrome Type A (also known as MPS IIIA), Sanfilippo Syndrome Type B (also known as MPS IIIB), Infantile Batten Disease (also known as CLN1 disease) and Juvenile Batten Disease (also known as CLN3 disease).
Consideration for the rights granted under the original Agreement included fees totaling $180 million and a running royalty on net sales, including: (i) an initial fee of $20 million, $10 million of which was due to REGENXBIO shortly after the effective date of the Agreement, and $10 million of which was due on the first anniversary of the effective date of the Agreement in November 2019, (ii) annual fees totaling $100 million, payable in $20 million annual installments beginning on the second anniversary of the effective date (the first of which remains payable if the Agreement is terminated before the second anniversary in November 2020), (iii) sales milestone payments totaling $60 million, and (iv) royalties payable in the low double digits to low teens on net sales of products covered under the Agreement.
As previously reported, on November 4, 2019, the Company and REGENXBIO amended the Agreement to replace the $10 million payment due to REGENXBIO on the first anniversary of the effective date with a provision under which REGENXBIO received $3 million in 2019 and was to receive an additional $8 million no later than April 1, 2020 (including $1 million in interest).
Prior to the April 1, 2020 deadline, the Company engaged REGENXBIO in discussions in an attempt to renegotiate the financial terms of the agreement, but the parties were unable to reach a mutual understanding that the Company believed would have been favorable for the Company or its programs, and the Company did not make the $8 million payment due by April 1, 2020. On April 17, 2020, REGENXBIO sent the Company a written demand for the $8 million fee, payable within a 15-day cure period after receipt of the demand letter. The license terminated on May 2, 2020, when the 15-day period expired. The Company is not subject to early termination penalties, but under the Agreement, REGENXBIO is due a total of $28 million, including one $20 million installment referenced in clause (ii) above, and the $8 million payment that was due on April 1, 2020.
A description of the terms and conditions of the Agreement is set forth under Item 1.01 of the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2018 and is incorporated herein by reference
 


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52 Re: License agreement with RegenX Dendrimer 0 5/12/2020 9:33:40 AM




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