Item 1.01. Entry into a Material Definitive Agreement.
On
· A worldwide exclusive license to certain antibodies that RubrYc develops under
what it calls its RTX-003 campaign, which are promising immuno-oncology antibodies that bind to the CD25 protein without interfering with the IL-2 signaling pathway thereby potentially depleting T regulatory (T reg) cells while enhancing T effector (T eff) cells and encouraging the immune system to attack cancer cells
· Options for iBio to license additional antibodies developed using RubrYc's
artificial intelligence-based antibody discovery platform
· Preferred stock in RubrYc
RTX -003 Collaboration and License Agreement
On
Under the terms and conditions of the RTX-003 License Agreement, the Company agreed to use commercially reasonable efforts to develop and commercialize RTX-003 antibodies. If the Company fails to achieve certain timing milestones for starting GMP manufacturing and dosing human patients under an IND, the Company could be required to make a payment to RubrYc on the date the milestone is missed and on each anniversary of such date until the milestone is achieved, provided that the milestone was missed due to the Company's failure to exercise commercially reasonable efforts.
iBio Development Milestones Successful 1st run GMP manufacture first licensed product 1st patient dosed under a licensed product
Under the terms of the RTX-003 License Agreement, RubrYc is eligible to receive
from the Company up to an aggregate of
· 5th patient dosed in a Phase I clinical study;
· 5th patient dosed in a Phase II clinical study;
· 4th patient dosed in a Phase III clinical study (payable in cash or Company
stock, at Company's discretion) and
· First commercial sale (payable in cash or Company stock, at Company's
discretion).
RubrYc will also be entitled to receive royalties in the mid-single digits on net sales of RTX-003 antibodies, subject to adjustment under certain circumstances. Royalties are payable on a country-by-country basis until the latest to occur of: (i) the last-to-expire of specified patent rights in such country; (ii) expiration of marketing or regulatory exclusivity in such country; or (iii) ten (10) years after the first commercial sale of a product in such country, provided that no biosimilar product has been approved in such country.
If either the Company or RubrYc materially breaches the RTX-003 License Agreement and does not cure such breach within 60 days (or 30 days in the event of non-payment), the non-breaching party may terminate the RTX-003 License Agreement in its entirety. Either party may also terminate the RTX-003 License Agreement, effective immediately upon written notice, if the other party files for bankruptcy, is dissolved or has a receiver appointed for substantially all of its property. RubrYc may terminate the RTX-003 License Agreement if the Company or its sublicensees challenges the validity or enforceability of any of RubrYc's Licensed Patents subject to certain exceptions. The Company may terminate the RTX-003 License Agreement in its entirety for any or no reason upon ninety (90) days' written notice to RubrYc. In addition, if RubrYc is unable to complete a financing with proceeds of a certain agreed upon amount by a set time defined in the RTX-003 License Agreement, the Company may terminate the RTX-003 License Agreement upon written notice to RubrYc within thirty (30) days of the end of such period. Effective upon such termination, among other things, RubrYc shall assign to the Company exclusive ownership of the RTX-003, including all relevant intellectual property rights.
Collaboration, Option and License Agreement
On
Under the terms and conditions of the Collaboration Agreement, in the event the option is exercised by the Company, the Company has various diligence obligations including that it will use commercially reasonable efforts to (i) develop Selected Compounds for use in pharmaceutical products (the "Collaboration Products"); and (ii) commercialize the Collaboration Products. The Company is also required to meet a series of development milestones for each Collaboration Product. Failure to achieve the milestones will result in a payment to RubrYc on the date the milestone is missed and on each anniversary of such date until the milestone is achieved, provided that the milestone was missed due to the Company's failure to exercise commercially reasonable efforts.
iBio Development Milestones per Collaboration Product per Program Successful 1st run GMP manufacture of the first Collaboration Product Initiate IND enabling studies for such Collaboration Product 1st patient dosed under such Collaboration Product
Under the terms of the Collaboration Agreement, RubrYc is eligible to receive
from the Company up to an aggregate of
1) 5th patient dosed in a Phase I clinical study;
2) 5th patient dosed in a Phase II clinical study;
3) 4th patient dosed in a Phase III clinical study (payable in cash or Company
stock, at Company's discretion) and
4) First commercial sale (payable in cash or Company stock, at Company's
discretion).
RubrYc will also be entitled to receive tiered royalties ranging from low- to mid-single digits on net sales of Collaboration Products, subject to adjustment under certain circumstances. Royalties are payable on a country-by-country and collaboration product-by-collaboration product basis until the latest to occur of: (i) the last-to-expire of specified patent rights in such country; (ii) expiration of marketing or regulatory exclusivity in such country; or (iii) ten (10) years after the first commercial sale of a product in such country, provided that no biosimilar product has been approved in such country.
If either the Company or RubrYc materially breaches the Collaboration Agreement and does not cure such breach within 60 days (or 30 days in the event of non-payment), the non-breaching party may terminate the Agreement in its entirety. Either party may also terminate the Collaboration Agreement, effective immediately upon written notice, if the other party files for bankruptcy, is dissolved or has a receiver appointed for substantially all of its property. RubrYc may terminate the Collaboration Agreement if the Company, its affiliates or its sublicensees challenges the validity or enforceability of any of RubrYc's patents covering any of the licensed compounds or products. The Company may terminate the Collaboration Agreement in its entirety, or with respect to a program, collaboration or Selected Compound for any or no reason upon ninety (90) days' written notice to RubrYc.
In addition, if RubrYc is unable to complete a financing with proceeds of a certain agreed upon amount by a set time defined in the Collaboration Agreement, the Company may terminate the Collaboration Agreement upon written notice to RubrYc within thirty (30) days of the end of such period. Effective upon such termination, among other things, RubrYc shall assign to the Company exclusive ownership of the Collaboration Hit Candidates (as defined in the Collaboration Agreement) that are in the then-current (un-terminated) discovery collaboration plans, including all relevant intellectual property rights.
The Stock Purchase Agreement and Related Financing Documents
In connection with the entry into the Collaboration Agreement and RTX-003
License Agreement, the Company also entered into a Stock Purchase Agreement
("Stock Purchase Agreement") with RubrYc whereby it purchased 1,909,563 shares
of RubrYc's Series A-2 preferred stock "Series A-2 Preferred") for
The rights, preferences of and privileges of the RubrYc Series A-2 Preferred
Stock ("Series A-2 Preferred") are set forth in the Third Amended and Restated
Certificate of Incorporation of
The Right of First Refusal and Co-Sale Agreement gives RubrYc the right of first refusal on stock sales by key holders, generally defined as founders, and a second right of first refusal and a co-sale right to specified other investors, including certain holders of Senior Preferred Stock and the Company.
The Investors' Rights Agreement provides the holders of Senior Preferred Stock with, among things: (i) demand registration rights, under specified circumstances; (ii) piggyback registration rights in the event of a company registered offering; (iii) lock-up and market-standoff obligations following a registered underwritten public offering; (iv) preemptive rights on company offered securities; and (v) additional protective covenants that require the approval at least two of the three directors elected by the holders of the Senior Preferred Stock .
Pursuant to the Voting Agreement, certain RubrYC stockholders are contractually obligated to, among other things, vote for and maintain the authorized number of directors at five members, one of which the Company has the contractual right to elect subject to the conditions set forth above.
The foregoing summary descriptions of the Collaboration Agreement, the RTX-003 License Agreement, the Stock Purchase Agreement, the Investors' Rights Agreement, the Voting Agreement, the Right of First Refusal and Co-Sale Agreement and Amended RubrYc COI are not complete and are qualified in their entirety by reference to the full text of the Collaboration Agreement, the Collaboration and License Agreement, the Stock Purchase Agreement, the Investor Rights Agreement, the Voting Agreement, the Right of First Refusal and Co-Sale Agreement and Amended RubrYc COI, a copies of which are filed as Exhibits 10.1, 10.2, 10.3, 10.4, 10.5 and 10.6 and 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibits are filed with this Current Report on Form 8-K:
Exhibit Number Description 10.1 †* Collaboration, Option and License Agreement, datedAugust 23, 2021 , by and betweeniBio, Inc. andRubrYc Therapeutics, Inc. 10.2 †* Collaboration and License Agreement, datedAugust 23, 2021 , by and betweeniBio, Inc. andRubrYc Therapeutics, Inc. 10.3†* Stock Purchase Agreement, datedAugust 23, 2021 , by and betweeniBio, Inc. andRubrYc Therapeutics, Inc. 10.4†* Second Amended and Restated Investor Rights Agreement, datedAugust 23, 2021 , by and amongRubrYc Therapeutics, Inc. and certain investors 10.5†* Second Amended and Restated Voting Agreement, datedAugust 23, 2021 , by and amongRubrYc Therapeutics, Inc. and certain investors 10.6†* Second Amended and Restated Right of First Refusal and Co-Sale Agreement, datedAugust 23, 2021 , by and amongRubrYc Therapeutics, Inc. and certain investors 99.1 Third Amended and Restated Certificate of Incorporation of RubrYcTherapeutics, Inc.
*Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K.
†The Company has omitted certain portions of the Collaboration, Option and
License Agreement and the Collaboration and License Agreement, Stock Purchase
Agreement, Investors' Rights Agreement, Voting Agreement, and Right of First
Refusal and Co-Sale Agreement in accordance with Item 601(b)(10) of Regulation
S-K.
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