LaundryMoney thought there was a 2-year timeline c
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Posted On: 09/09/2021 10:56:01 AM
Re: LaundryMoney #103087
LaundryMoney thought there was a 2-year timeline clause with Vyera re BLA approval. I found the details on EDGAR in 10-Q filed 2020-01-09 and pasted excerpts below. Hats off to LaundryMoney for remembering 2 years.
Note that this could have been revised later. I did not look beyond this 10-Q.
COMMERCIALIZATION AND LICENSE AGREEMENT
https://www.sec.gov/Archives/edgar/data/11756...dex105.htm
Exh 10.5 of 10-Q filed 2020-01-09
This Commercialization and License Agreement (this “Agreement”) is made effective as of December 17, 2019 (the “Effective Date”) by and between Vyera Pharmaceuticals, LLC, a Delaware limited liability company (“Vyera”), and CytoDyn Inc., a Delaware corporation (“CytoDyn”). CytoDyn and Vyera are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
1.94 “Royalty Term” means the time period beginning with the First Commercial Sale of the Licensed Product in the Territory and continuing until the latest of (a) the expiration of the last Valid Claim Covering the Licensed Product and included in a CytoDyn Patent licensed to Vyera under this Agreement, (b) the date that is ten (10) years from the date of the First Commercial Sale, (c) the expiration of any Regulatory Exclusivity with respect to the Licensed Product and (d) the Biosimilar Entry Date.
ARTICLE 11
TERM AND TERMINATION
11.1 Term. The term of this Agreement (“Term”) shall commence upon the Effective Date and, unless earlier terminated pursuant to this Article 11, shall expire on the last day of the Royalty Term. Upon the expiration of the Royalty Term, the license granted to Vyera under Section 2.1 of this Agreement shall become non-exclusive, fully-paid, royalty free, perpetual and irrevocable. Notwithstanding the foregoing, if Vyera exercises the Continuation Right (as defined in the Supply Agreement), then Vyera shall continue to purchase Licensed Product from CytoDyn pursuant to the Supply Agreement and shall pay CytoDyn for such Licensed Product the price specified in the Supply Agreement and a royalty equal to [***], provided that after the exercise of the Continuation Right, CytoDyn will not be obligated to supply Licensed Product exclusively to Vyera in the Field in the Territory.
11.2 Unilateral Termination by Vyera. Vyera shall have the right to terminate this Agreement in its entirety:
(a) on or after the second (2nd) anniversary of the Effective Date, upon written notice to CytoDyn in the event the approval by the FDA of the BLA for the Licensed Product for the Manufacture and sale of the Licensed Product in the U.S. for the Initial Indication has not been received by such second (2nd) anniversary; provided, however, that in the event of a delay that would reasonably be expected to result in the receipt of BLA approval on or after such second (2nd) anniversary, then Vyera may terminate this Agreement pursuant to this Section 11.2(a) prior to the second (2nd) anniversary upon [***] notice to CytoDyn;
(b) following the occurrence of a Commercial Failure, upon [***] written notice to CytoDyn; provided, however, that Vyera’s right to terminate this Agreement pursuant to this Section 11.2(b) shall only be exercisable during the [***] period following the date when sales data with respect to a Commercial Failure becomes available to Vyera; and
(c) at any time following the second (2nd) anniversary of the First Commercial Sale of the Licensed Product, for any reason or no reason, upon one hundred eighty (180) days’ written notice to CytoDyn.
11.3 Unilateral Termination by CytoDyn. CytoDyn shall have the right to terminate this Agreement in its entirety upon written notice to Vyera on the occurrence of any of the following:
(a) Vyera or any of its Affiliates directly or indirectly, challenges, disputes, or assists any Third Party to dispute or challenge, in a legal or administrative proceeding the patentability, enforceability or validity of any CytoDyn Patents;
(b) Vyera fails to make a First Commercial Sale within sixty (60) days following the later of (i) the date Regulatory Approval is obtained and (ii) the date CytoDyn supplies (or is ready to supply) Vyera with the Licensed Product for sale pursuant to the Supply Agreement (the “Supply Date”);
(c) Vyera breaches its obligations or covenants under Section 2.6 (Competitive Products);
(d) Upon [***] written notice, in the event Vyera fails to meet any of the Minimum Requirements and has not cured such failure, to the extent curable, within such notice period; or
(e) Vyera fails to make the Equity Investment within seven (7) days of the Effective Date, as required by Section 8.13.
CytoDyn’s right to terminate this Agreement pursuant to this Section 11.3 must be exercised within [***] following the occurrence of the applicable event or circumstance under the immediately preceding clauses (a)-(d) giving rise to CytoDyn’s right to terminate this Agreement.
SUPPLY AGREEMENT
https://www.sec.gov/Archives/edgar/data/11756...dex106.htm
Exh 10.6 of 10-Q filed 2020-01-09
This Supply Agreement (this “Agreement”) is made effective as of December 17, 2019 (the “Effective Date”) by and between Vyera Pharmaceuticals, LLC, a Delaware limited liability company (“Vyera”), and CytoDyn Inc., a Delaware corporation (“CytoDyn”). CytoDyn and Vyera are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
9.1 Term. The term of this Agreement (the “Term”) shall commence upon the Effective Date and, unless earlier terminated pursuant to this Article 9, shall remain in effect until the expiration of the Royalty Term (as defined in the Commercialization Agreement); provided, however, that following the Royalty Term, Vyera shall have the right (the “Continuation Right”), in its sole discretion, to extend the Term for so long as Vyera agrees to pay CytoDyn the royalty payments required to be paid pursuant to Section 11.1 of the Commercialization Agreement with respect to Products supplied to it under this Agreement following the Royalty Term. If Vyera elects to exercise the Continuation Right, it shall deliver a notice to CytoDyn at least [***] prior to the initial slated expiration of the Term. In the event that Vyera decides to terminate this Agreement after its exercise of the Continuation Right, it will provide CytoDyn with written notice at least [***] prior to such termination.
Note that this could have been revised later. I did not look beyond this 10-Q.
COMMERCIALIZATION AND LICENSE AGREEMENT
https://www.sec.gov/Archives/edgar/data/11756...dex105.htm
Exh 10.5 of 10-Q filed 2020-01-09
This Commercialization and License Agreement (this “Agreement”) is made effective as of December 17, 2019 (the “Effective Date”) by and between Vyera Pharmaceuticals, LLC, a Delaware limited liability company (“Vyera”), and CytoDyn Inc., a Delaware corporation (“CytoDyn”). CytoDyn and Vyera are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
1.94 “Royalty Term” means the time period beginning with the First Commercial Sale of the Licensed Product in the Territory and continuing until the latest of (a) the expiration of the last Valid Claim Covering the Licensed Product and included in a CytoDyn Patent licensed to Vyera under this Agreement, (b) the date that is ten (10) years from the date of the First Commercial Sale, (c) the expiration of any Regulatory Exclusivity with respect to the Licensed Product and (d) the Biosimilar Entry Date.
ARTICLE 11
TERM AND TERMINATION
11.1 Term. The term of this Agreement (“Term”) shall commence upon the Effective Date and, unless earlier terminated pursuant to this Article 11, shall expire on the last day of the Royalty Term. Upon the expiration of the Royalty Term, the license granted to Vyera under Section 2.1 of this Agreement shall become non-exclusive, fully-paid, royalty free, perpetual and irrevocable. Notwithstanding the foregoing, if Vyera exercises the Continuation Right (as defined in the Supply Agreement), then Vyera shall continue to purchase Licensed Product from CytoDyn pursuant to the Supply Agreement and shall pay CytoDyn for such Licensed Product the price specified in the Supply Agreement and a royalty equal to [***], provided that after the exercise of the Continuation Right, CytoDyn will not be obligated to supply Licensed Product exclusively to Vyera in the Field in the Territory.
11.2 Unilateral Termination by Vyera. Vyera shall have the right to terminate this Agreement in its entirety:
(a) on or after the second (2nd) anniversary of the Effective Date, upon written notice to CytoDyn in the event the approval by the FDA of the BLA for the Licensed Product for the Manufacture and sale of the Licensed Product in the U.S. for the Initial Indication has not been received by such second (2nd) anniversary; provided, however, that in the event of a delay that would reasonably be expected to result in the receipt of BLA approval on or after such second (2nd) anniversary, then Vyera may terminate this Agreement pursuant to this Section 11.2(a) prior to the second (2nd) anniversary upon [***] notice to CytoDyn;
(b) following the occurrence of a Commercial Failure, upon [***] written notice to CytoDyn; provided, however, that Vyera’s right to terminate this Agreement pursuant to this Section 11.2(b) shall only be exercisable during the [***] period following the date when sales data with respect to a Commercial Failure becomes available to Vyera; and
(c) at any time following the second (2nd) anniversary of the First Commercial Sale of the Licensed Product, for any reason or no reason, upon one hundred eighty (180) days’ written notice to CytoDyn.
11.3 Unilateral Termination by CytoDyn. CytoDyn shall have the right to terminate this Agreement in its entirety upon written notice to Vyera on the occurrence of any of the following:
(a) Vyera or any of its Affiliates directly or indirectly, challenges, disputes, or assists any Third Party to dispute or challenge, in a legal or administrative proceeding the patentability, enforceability or validity of any CytoDyn Patents;
(b) Vyera fails to make a First Commercial Sale within sixty (60) days following the later of (i) the date Regulatory Approval is obtained and (ii) the date CytoDyn supplies (or is ready to supply) Vyera with the Licensed Product for sale pursuant to the Supply Agreement (the “Supply Date”);
(c) Vyera breaches its obligations or covenants under Section 2.6 (Competitive Products);
(d) Upon [***] written notice, in the event Vyera fails to meet any of the Minimum Requirements and has not cured such failure, to the extent curable, within such notice period; or
(e) Vyera fails to make the Equity Investment within seven (7) days of the Effective Date, as required by Section 8.13.
CytoDyn’s right to terminate this Agreement pursuant to this Section 11.3 must be exercised within [***] following the occurrence of the applicable event or circumstance under the immediately preceding clauses (a)-(d) giving rise to CytoDyn’s right to terminate this Agreement.
SUPPLY AGREEMENT
https://www.sec.gov/Archives/edgar/data/11756...dex106.htm
Exh 10.6 of 10-Q filed 2020-01-09
This Supply Agreement (this “Agreement”) is made effective as of December 17, 2019 (the “Effective Date”) by and between Vyera Pharmaceuticals, LLC, a Delaware limited liability company (“Vyera”), and CytoDyn Inc., a Delaware corporation (“CytoDyn”). CytoDyn and Vyera are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
9.1 Term. The term of this Agreement (the “Term”) shall commence upon the Effective Date and, unless earlier terminated pursuant to this Article 9, shall remain in effect until the expiration of the Royalty Term (as defined in the Commercialization Agreement); provided, however, that following the Royalty Term, Vyera shall have the right (the “Continuation Right”), in its sole discretion, to extend the Term for so long as Vyera agrees to pay CytoDyn the royalty payments required to be paid pursuant to Section 11.1 of the Commercialization Agreement with respect to Products supplied to it under this Agreement following the Royalty Term. If Vyera elects to exercise the Continuation Right, it shall deliver a notice to CytoDyn at least [***] prior to the initial slated expiration of the Term. In the event that Vyera decides to terminate this Agreement after its exercise of the Continuation Right, it will provide CytoDyn with written notice at least [***] prior to such termination.
(3)
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