UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 5, 2015
Eagle Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36306 |
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20-8179278 |
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(State or other jurisdiction |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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of incorporation) |
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50 Tice Boulevard, Suite 315
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07677 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (201) 326-5300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement
Robert One, LLC Amendment to Development and Licensing Agreement
On August 5, 2015, Eagle Pharmaceuticals, Inc., or the Company, entered into Amendment No. 2 to Development and Licensing Agreement (the “Second Amendment”) with Robert One, LLC (“Robert One”) to revise the “Royalty Rate” as defined in the Development and Licensing Agreement, dated as of February 13, 2009, as amended (the “Robert Development and Licensing Agreement”). The Robert Development and Licensing Agreement is described in the Company’s Registration Statement on Form S-1, filed with the Securities and Exchange Commission on December 20, 2013, and attached thereto as Exhibit 10.18.
The Second Amendment revises the definition of “Royalty Rate” to mean: (i) 50% with respect to a 505(b)(2) application; (ii) 30% with respect to an ANDA application; and (iii) 25% with respect to the Pemetrexed parenteral formulation.
The foregoing summary of the Second Amendment is qualified in its entirety by reference to the text of the Second Amendment, a copy of which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference herein.
SciDose LLC Amendment to Development and Licensing Agreement
On August 5, 2015, the Company entered into Amendment No. 4 to Development and Licensing Agreement (the “Fourth Amendment”) with SciDose LLC (“SciDose”) to waive certain claims against SciDose and to revise the “Royalty Rate” as defined in the Development and Licensing Agreement, dated as of June 12, 2007, as amended (the “SciDose Development and Licensing Agreement”). The SciDose Development and Licensing Agreement is described in the Company’s Registration Statement on Form S-1, filed with the Securities and Exchange Commission on December 20, 2013, and attached thereto as Exhibit 10.11(b).
The Fourth Amendment revises the definition of “Royalty Rate” to mean: (i) 15% with respect to the Eagle Bivalirudin Product; (ii) 50% with respect to any Product that is subject to a 505(b)(2) application; and (iii) 30% with respect to any Product that is subject to an ANDA application. In addition, the Company agreed to waive any claim against SciDose for the recovery from SciDose of either (i) any unreimbursed costs incurred by the Company related to the development of the Eagle Bivalirudin Product, and (ii) any refund of certain milestone payments previously made by the Company to SciDose under the SciDose Development and Licensing Agreement relating to any parenteral formulation of Bivalirudin, through and including the date of the Fourth Amendment.
The foregoing summary of the Fourth Amendment is qualified in its entirety by reference to the text of the Fourth Amendment, a copy of which is attached as Exhibit 10.2 to this Current Report on Form 8-K and incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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Exhibit |
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Description |
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10.1 |
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Amendment No. 2 to Development and Licensing Agreement between Eagle Pharmaceuticals, Inc. and Robert One, LLC, dated as of August 5, 2015 |
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10.2 |
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Amendment No. 4 to Development and Licensing Agreement between Eagle Pharmaceuticals, Inc. and SciDose LLC, dated as of August 5, 2015 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Eagle Pharmaceuticals, Inc. |
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Dated: August 11, 2015 |
By: |
/s/ Scott Tarriff |
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Scott Tarriff |
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President and Chief Executive Officer |
Exhibit Index
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Exhibit |
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Description |
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10.1 |
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Amendment No. 2 to Development and Licensing Agreement between Eagle Pharmaceuticals, Inc. and Robert One, LLC, dated as of August 5, 2015 |
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10.2 |
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Amendment No. 4 to Development and Licensing Agreement between Eagle Pharmaceuticals, Inc. and SciDose LLC, dated as of August 5, 2015 |
Exhibit 10.1
AMENDMENT NO. 2 TO
DEVELOPMENT AND LICENSING AGREEMENT
THIS AMENDMENT NO. 2 TO THE DEVELOPMENT AND LICENSING AGREEMENT (the “Amendment”) is made as of August 5, 2015 (the “Amendment Date”), by and between Eagle Pharmaceuticals, Inc. (“Eagle”), and Robert One, LLC, (“Robert”), and amends the February 13, 2009 Development and Licensing Agreement (the “Original Agreement”), by and between Eagle and Robert as amended on December 23, 2010. Capitalized terms used in this Amendment and not otherwise defined shall have the same meanings ascribed to such terms in the Original Agreement.
WHEREAS , Eagle and Robert desire to amend the Original Agreement, as more particularly set forth herein.
NOW, THEREFORE , in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Eagle and SciDose agree as follows:
1. Amendment to Section 1.37 . Section 1.37 of the Original Agreement is hereby amended by deleting the entire clause and replacing it with:
1.37 “ROYALTY RATE” means (i) fifty percent (50%) with respect to a 505(b)(2) application; (ii) thirty percent (30%) with respect to an ANDA application; and (iii) twenty-five percent (25%) with respect to the Pemetrexed parenteral formulation.
2. Effect on the Original Agreement . Except as specifically amended herein, the Original Agreement, all other documents, instruments and agreements executed and/or delivered in connection therewith, shall remain in full force and effect, and are hereby ratified and confirmed. Each reference in the Original Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of like import shall mean and be a reference to the Original Agreement as amended hereby.
3. Entire Agreement . The Original Agreement, as modified by this Amendment, and the other writings specifically identified therein and herein or contemplated thereby and hereby, is complete, reflects the entire agreement of the Parties with respect to the subject matter hereof, and supersedes all previous written or oral negotiations, commitments and writings.
4. Counterparts . This Amendment may be executed in counterparts, each of which shall be deemed an original and any of which shall constitute a single document. A facsimile (or pdf) signature of an authorized signatory of any Party shall be valid and binding and constitute due execution and delivery of this Amendment by such Party.
5. Governing Law . This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware without regard to its conflict of law rules or principles.
IN WITNESS WHEREOF , the Parties have caused this Amendment to be executed and delivered by their respective proper and duly authorized representatives as of the date first set forth above.
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EAGLE PHARMACEUTICALS, INC. |
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By: |
/s/ Scott Tarriff |
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Name: |
Scott Tarriff |
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Title: |
President and CEO |
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ROBERT ONE, LLC |
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By: |
/s/ Joseph Bohan |
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Name: |
Joseph Bohan |
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Title: |
President and CEO |
Exhibit 10.2
AMENDMENT NO. 4 TO
DEVELOPMENT AND LICENSING AGREEMENT
THIS AMENDMENT NO. 4 TO THE DEVELOPMENT AND LICENSING AGREEMENT (the “Amendment”) is made as of August 5, 2015 (the “Amendment Date”), by and between Eagle Pharmaceuticals, Inc. (“Eagle”), and SciDose LLC, (“SciDose”), and amends the June 12, 2007 Development and Licensing Agreement (the “Original Agreement”), by and between Eagle and SciDose. Capitalized terms used in this Amendment and not otherwise defined shall have the same meanings ascribed to such terms in the Original Agreement, as previously amended.
WHEREAS , Eagle and SciDose desire to amend the Original Agreement, as more particularly set forth herein.
NOW, THEREFORE , in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Eagle and SciDose agree as follows:
1. Amendment to Section 1.30 (ii) . The general reference to “all parenteral formulations of Bivalirudin” in Section 1.30 (ii) is deleted, and replaced with:
1.30 (ii) the Eagle ready-to-use (“RTU”) Bivalirudin product (the “Eagle Bivalirudin Product”) that is the subject of the 505(b)(2) New Drug Application (“NDA”) submitted to the U.S. Food and Drug Administration on or about May 20, 2015.
2. Amendment to Section 1.35 . Section 1.35 of the Original Agreement, as previously amended, is hereby amended by deleting the entire clause and replacing it with:
1.35 “ROYALTY RATE” means (i) with respect to the EAGLE BIVALIRUDIN PRODUCT, fifteen percent (15%); (ii) with respect to any PRODUCT that is subject to a 505(b)(2) application, fifty percent (50%); and (iii) with respect to any PRODUCT that is subject to an ANDA application, thirty percent (30%).
3. Development Costs and Milestone Payments Made By Eagle . Eagle hereby waives any claim of any kind that it may have and which could be asserted through and including the Amendment Date against SciDose for the recovery from SciDose of either (i) any unreimbursed costs incurred by Eagle related to the development of the Eagle Bivalirudin Product, and (ii) any refund of milestone payments under Sections 4.1.3 and 3.1.2 of the Original Agreement that were previously made by Eagle to SciDose relating to any parenteral formulation of Bivalirudin.
4. Effect on the Original Agreement . Except as specifically amended herein, the Original Agreement, all other documents, instruments and agreements executed and/or delivered in connection therewith, shall remain in full force and effect, and are hereby ratified and confirmed. Each reference in the Original Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of like import shall mean and be a reference to the Original Agreement as amended hereby.
5. Entire Agreement . The Original Agreement, as modified by this Amendment, and the other writings specifically identified therein and herein or contemplated thereby and hereby, is complete, reflects the entire agreement of the Parties with respect to the subject matter hereof, and supersedes all previous written or oral negotiations, commitments and writings.
6. Counterparts . This Amendment may be executed in counterparts, each of which shall be deemed an original and any of which shall constitute a single document. A facsimile (or pdf) signature of an authorized signatory of any Party shall be valid and binding and constitute due execution and delivery of this Amendment by such Party.
7. Governing Law . This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware without regard to its conflict of law rules or principles.
IN WITNESS WHEREOF , the Parties have caused this Amendment to be executed and delivered by their respective proper and duly authorized representatives as of the date first set forth above.
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EAGLE PHARMACEUTICALS, INC. |
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By: |
/s/ Scott Tarriff |
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Name: |
Scott Tarriff |
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Title: |
President and CEO |
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SCIDOSE, LLC |
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By: |
/s/ Joseph Bohan |
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Name: |
Joseph Bohan |
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Title: |
President and CEO |