FIRST AMENDMENT TO RESEARCH COLLABORATION AND LICENSE AGREEMENT
Exhibit 10.48
FIRST AMENDMENT TO RESEARCH COLLABORATION AND LICENSE AGREEMENT
This First Amendment to the Research Collaboration and License Agreement (this “Amendment”), dated as of August 2, 2024 is entered into by and among Palisade Bio, Inc., a Delaware corporation (“Palisade” or “Licensee”) and Giiant Pharma, Inc., a Canadian federal corporation (“Giiant” or “Licensor”). Each of Licensor and Licensee may be referred to in this Amendment individually as a “Party” and collectively the “Parties.” Capitalized terms not defined in this Amendment will have the meaning ascribed to them in the Original License (as defined below). Additionally, all Capitalized terms defined in this Amendment will be deemed incorporated into and amend the Original Agreement.
RECITALS
WHEREAS, the Parties entered into that certain Research Collaboration and License Agreement effective as of September 1, 2023 (the “Original Agreement”);
WHEREAS, pursuant to the Original Agreement, each Party had certain funding obligations as more fully described and identified in the Original Agreement and Development Budget;
WHEREAS, Palisade has agreed to reduce Giiant’s funding obligations by US$[***] (the “Reduced Contribution”) and has agreed to allow Giiant to retain US$[***] (“2024 Retained SRED Credit”) from the proceeds of its anticipated Scientific Research & Experimental Development Tax Credit (“SRED Credit”) related to activities for the fiscal year ending June 30, 2024 (“2024 SRED Credit”) and to retain US$[***] (“2025 Retained SRED Credit”) from the proceeds of its anticipated SRED Credit related to activities in its fiscal year ending June 30, 2025 (“2025 SRED Credit”) in exchange for Giiant agreeing to a reduction of: (i) US$[***] ([***]x the Reduced Contribution plus the 2024 Retained SRED Credit and 2025 Retained SRED Credit) to the aggregate Milestone Payments; and (ii) US$[***] ([***]x the Reduced Contribution) to the Payment Cap;
WHEREAS, the Parties have agreed to amend the Original Agreement, including the Development Budget, in order to provide that the Reduced Contribution will be paid by Xxxxxxxx;
WHEREAS, pursuant to the Original Agreement and Development Budget, Giiant has agreed to contribute US$[***] from a Crohn’s & Colitis Foundation grant that it previously received (the “CCF Grant Funds”), of which they have previous contributed US$[***] with the balance of US$[***] to be contributed in the future pursuant to the Development Budget;
WHEREAS, Giiant has obtained a CAD$[***] loan to assist in funding its obligations under the Original Agreement and Development Budget (“Loan”)
WHEREAS, Palisade has agreed that up to an aggregate of US$[***] from the 2024 and 2025 SRED Credits may be pledged as collateral for the repayment of the Loan by Xxxxxx;
WHEREAS, the Parties have agreed that any reference to the Development Budget contained in the Original Agreement will mean the amended and restated Development Budget attached hereto as Exhibit A; and
WHEREAS, the Parties have agreed to additional amendments and restatements to the Original Agreement as provided for herein.
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Exhibit 10.48
NOW, THEREFORE, in consideration of the mutual covenants and promises set forth in this Amendment, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
“(d) Development Expense. Licensee will advance and/or reimburse Licensor up to [***] Dollars (US$[***]) of costs and expenses incurred during the Development Program Term (which such amount can only be increased by the unanimous consent of all members of the JDC) related to the Development of the GT-2108 molecule; inclusive of consultant, personnel and employee costs but exclusive of any value added tax subject to Section 5.04(k) (“VAT Tax”), as provided for in the Development Budget. Advances and/or Reimbursements will be made pursuant to the procedure contained in Section 5.04(g).”
“(f) Grant/Tax Credit Applications. During the period commencing on the Effective Date and ending after achieving the first Proof of Concept related to the Licensed Compound and Licensed Product, Licensor will use Commercially Reasonable Efforts to apply for and secure research and development grants or tax credits (“R&D Grant/
Credit”) to assist in funding the Development Plan. Upon receipt of an approval with regard to any R&D Grant/Credit, Licensor will promptly notify Licensee that Licensor has received such and the amount of such R&D Grant/Credit. Within five (5) Business Days of receiving the proceeds from such R&D Grant/Credit, Licensor will notify Licensee that such proceeds have been received by Licensor. Licensor will have twelve (12) Business Days from receipt of the R&D Grant/Credit proceeds, to transfer such proceeds to Licensee. If the R&D Grant/Credit proceeds are not received within twelve (12) Business Days of receipt by Licensor, Licensor will be deemed to be in material breach of this Agreement, irrespective of the Cure Period provided for in Section 14.04 and Licensee will be entitled to the remedies set forth in Section 14.06 upon notice and without providing Licensor with the Cure Period.”
“(g) Advances and/or Reimbursements Procedure. Any advances and/or reimbursements to Licensor by Licensee pursuant to the Development Budget, Development Plan and reimbursement of a VAT Tax pursuant to Section 5.04(k), will be made pursuant to the procedures set forth in this Section 5.04(g). On or about the 1st and 15th of each calendar month during the Development Program Term, Licensor will provide to Licensee a schedule detailing the costs, expenses or VAT Tax incurred or to be incurred, including any required deposits or prepayments, related to the Development as well as the party that was or will be paid and such other information as the JDC may reasonably request (each, a “Funding Request”)(in the case of a request to advance a VAT Tax, Licensor will provide the VAT Tax invoice). Upon receipt of a Funding Request (which contains all the information reasonably requested by the JDC), the JDC shall within ten (10) Business Days of receipt of such Funding Request, either: (i), approve such Funding Request provided it is consistent with the Development Budget, Development Plan and the terms of this Agreement (each, an “Approved Payment”) or (ii) request additional information from
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Licensor regarding the items contained in the Funding Request. In the event of an Approved Payment, the JDC will then notify Licensor of the Approved Payment amount and that Licensee is prepared to transfer such amount. Licensor must then provide Licensee written confirmation that it is prepared to receive such Approved Payment, and Licensee shall remit such payment within two (2) Business Days of receiving such confirmation. Upon receipt of the Approved Payment, Licensor will have five (5) Business Days (the “Verification Period”) to submit proof, in such form as reasonably requested by the Licensee, that the Approved Payment has been paid to the respective third parties as described in the Funding Request (“Payment Verification”). If Payment Verification, in such form as reasonably required by Licensee is not provided during the Verification Period, Licensee may provide Licensor with a notice of breach (“Verification Breach”). In the event the Verification Breach is not cured within five (5) Business Days from Licensee’s notification to Licensor of such Verification Breach, irrespective of the longer Cure Period provided for in Section 14.04, Licensor will be deemed in material breach of this Agreement and Licensee will be entitled to the remedies set forth in Section 14.06, upon notice and without providing Licensor with the Cure Period.”
“(h) 2024 SRED Credit Contribution. Upon receipt of the proceeds from the 2024 SRED Credit, Licensor will have five (5) Business Days to notify Licensee that Licensor has received the proceeds from the 2024 SRED Credit and the amount of such proceeds. Licensor will have twelve (12) Business Days from the day Licensor receives the proceeds from the 2024 SRED Credit to submit to Licensee the 2024 SRED Credit proceeds less the amount of the 2024 Retained SRED Credit (“2024 SRED Credit Balance”) with such proceeds to be held by Licensee to pay for development expenses pursuant to the Development Budget. If the 2024 SRED Credit Balance is not received by Licensee within twelve (12) Business Days of Licensor’s receipt of the 2024 SRED Credit proceeds, Licensor will be deemed to be in material breach of this Agreement, irrespective of the Cure Period provided for in Section 14.04 and Licensee will be entitled to the remedies set forth in Section 14.06 upon notice and without providing Licensor with the Cure Period.”
“(i) 2025 SRED Credit Contribution. Upon receipt of the proceeds from the 2025 SRED Credit, if any, Licensor will have five (5) Business Days to notify Licensee that Licensor has received the proceeds from the 2025 SRED Credit and the amount of such proceeds. Licensor will have twelve (12) Business Days from the day Licensor receives the proceeds from the 2025 SRED Credit to submit to Licensee the 2025 SRED Credit proceeds less the amount of the 2025 Retained SRED Credit (“2025 SRED Credit Balance”) with such proceeds to be held by Licensee to pay for development expenses pursuant to the Development Budget. If the 2025 SRED Credit Balance is not received by Licensee within twelve (12) Business Days of Licensor’s receipt of the 2025 SRED Credit proceeds, Licensor will be deemed to be in material breach of this Agreement, irrespective of the Cure Period provided for in Section 14.04 and Licensee will be entitled to the remedies set forth in Section 14.06 upon notice and without providing Licensor with the Cure Period.”
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“(j) Development VAT Taxes. If a VAT Tax or any equivalent tax is required under Applicable Law to be levied on any payment made by Licensor pursuant to a payment related to the Development Plan or Development Budget, Licensee will pay such tax in addition to the sums due under Section 5.04(d), provided that Licensor shall supply a VAT Tax invoice to Licensee and subject to Licensor’s adherence to the procedures contained in Section 5.04(g). Upon receipt of a government reimbursement of any VAT Tax or any equivalent tax related to any VAT Tax invoice previously submitted to, and which funds were advanced by, Licensee, Licensor will have two (2) Business Days to notify Licensee that Licensor has received such proceeds and the amount of such reimbursement. Licensor will have ten (10) Business Days to submit to Licensee all the proceeds from such reimbursement. If the proceeds are not received by Licensee within ten (10) Business Days of Licensor’s receipt of such proceeds, Licensor will be deemed to be in material breach of this Agreement, irrespective of the Cure Period provided for in Section 14.04 and Licensee will be entitled to the remedies set forth in Section 14.06 upon notice and without providing Licensor with the Cure Period.
“(c) Events Triggering Milestone Payments. Licensee will pay Licensor the following compensation (each, a “Milestone Payment”), subject to the limitations contained in Section 9.03, upon the following milestone events:
Milestone Event
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Milestone Payment Amount |
The first administration to a patient in a Phase 1b Clinical Trial or Phase 2 Clinical Trial, whichever comes first of any Licensed Technology, Licensed Compound or Licensed Product.
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[***] U.S. Dollars (US$[***]), at Licensee’s sole and absolute discretion in either cash and/or Common Stock (or any combination thereof) with such Common Stock being valued on the third (3rd) Trading Day after the Public Announcement of such milestone event |
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The completion of the first Phase 2 Clinical Trial which meets its primary endpoint of statistical significant efficacy allowing the Parties to proceed with the first Phase 3 Clinical Trial of any Licensed Technology, Licensed Compound or Licensed Product.
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[***] U.S. Dollars (US$[***]) at Licensee’s sole and absolute discretion in either cash and/or Common Stock (or any combination thereof), with such Common Stock being valued on the third (3rd) Trading Day after the Public Announcement of such milestone event.” |
“Section 9.03 Royalty and Milestone Cap. Royalty Payments and Milestone Payments will be subject to an aggregate cap of [***]U.S. Dollars (US$[***]), subject to adjustment as follows: (i) if advances and/or reimbursements as described in Section 5.04(d) are greater than [***] U.S. Dollars (US$[***]), the payment cap will be decreased by the amount of such overage or (ii) if advances and/or reimbursements as described in Section 5.04(d) are less than [***] U.S. Dollars (US$[***]), the payment cap will be increased by the amount of such savings
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(“Payment Cap”); provided however that in the event this Agreement is terminated by Licensee pursuant to Section 14.03 or Section 14.04, all costs and expenses incurred by Licensee related to achieving Proof of Concept will also be deducted from the Payment Cap.”
“Section 14.04 Termination for Material Breach. Except as specifically stated herein, either Party (the “Non-breaching Party”) may terminate this Agreement at any time during the Term in its entirety in the event that the other Party (the “Breaching Party”) has materially breached the Agreement and such material breach has not been cured within ninety (90) days after receipt of written notice of such breach by the Breaching Party from the Non-Breaching Party (the “Cure Period”); provided however that upon the Payment Cap being achieved, Licensor will no longer be able to terminate this Agreement, for any reason; provided further that such Cure Period will not apply to any Section(s) that specifically provide for a different cure period, if any, including but not limited to Section 5.04(f) through and including Section 5.04(j), in which case Licensee will have the right to terminate this Agreement immediately, subject to any notice or cure period, if any, contained in such Sections. The written notice, if applicable, describing the alleged material breach shall provide sufficient detail to put the Breaching Party on notice of such material breach, unless the Cure Period is not applicable. Any termination of this Agreement pursuant to this Section 14.04 shall become effective at the end of the Cure Period, if applicable, or such other time as provided for in this Agreement, unless the Breaching Party has cured any such material breach prior to the expiration of such Cure Period, if any, or, if such material breach is not susceptible to cure within the Cure Period, if applicable, then the Non-Breaching Party’s right of termination shall be suspended only if and for so long as the Breaching Party has provided to the Non-Breaching Party a written plan that is reasonably calculated to effect a cure of such material breach, such plan is accepted by the Non-Breaching Party (such acceptance not to be unreasonably withheld, conditioned, or delayed), and the Breaching Party commits to and carries out such plan as provided to the Non-Breaching Party. The right of either Party to terminate this Agreement as provided in this Section 14.04 shall not be affected in any way by such Party’s waiver of or failure to take action with respect to any previous breach under this Agreement. Notwithstanding anything to the contrary, the Cure Period, if applicable, for any dispute (each, a “Dispute”) will run from the date that written notice, containing the required description of such material breach, was first provided to the Breaching Party by the Non-Breaching Party through the resolution of such Dispute pursuant to Article XV, and it is understood and acknowledged that, during the pendency of a dispute, all of the terms and conditions of this Agreement shall remain in effect, and the Parties shall continue to perform all of their respective obligations under this Agreement. Any payments that are made by one Party to the other Party pursuant to this Agreement pending resolution of the Dispute shall be promptly refunded if it is determined pursuant to Article XV that such payments are to be refunded by one Party to the other Party.”
“(c) If Licensee elects to have the rights and obligations pursuant to ARTICLE II and ARTICLE XI survive, subject to each Party’s rights to make claims against the other, the Parties’ rights and obligations under ARTICLE IX will also survive; provided however that if Licensee terminates this Agreement as a result of Licensor’s breach of any of Section 5.04(f) through and including Section 5.04(k), Licensee’s obligations under ARTICLE IX will terminate and Licensor will not be entitled to any Milestone Payments or Royalty Payments and all of
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Exhibit 10.48
Licensor’s other rights under this Agreement, if any, will terminate except as specifically stated herein;”
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[Signature Page Follows]
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IN WITNESS WHEREOF, the undersigned, intending to be legally bound hereby, have duly executed this Amendment as of the day and year first above written.
Licensor:
GIIANT PHARMA, INC.
By: /s/ Xxxxxxxxxx Xxxxxx
Name: Xxxxxxxxxx Xxxxxx
Title: CEO
Licensee:
By: /s/ X.X. Xxxxxx
Name: X.X. Xxxxxx
Title: CEO
EXHIBIT A
AMENDED AND RESTATED DEVELOPMENT BUDGET
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