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 11, 2015
ZOSANO PHARMA CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36570 |
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45-4488360 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
34790 Ardentech Court
Fremont, CA 94555
(Address of principal executive offices) (Zip Code)
(510) 745-1200
Registrants telephone number, including area code
Not applicable
(Former
name or former address, if changed since last report.)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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. |
On August 11, 2015, our wholly owned
subsidiary, ZP Opco, Inc., entered into an Amendment No. 1 to Collaboration, Development and License Agreement with Eli Lilly and Company. Amendment No. 1 amends the Collaboration, Development and License Agreement dated as of
November 21, 2014 between ZP Opco, Inc. and Eli Lilly and Company, to extend by two months the date by which the parties must agree upon certain development plans and a commercial supply chain for a specified period for our Daily ZP-PTH product
candidate, and to clarify the parties rights with respect to the manufacture of commercial supplies of Daily ZP-PTH. Eli Lilly and Company is known by us to beneficially own more than ten percent of our outstanding common stock. The foregoing
description of Amendment No. 1 to Collaboration, Development and License Agreement is qualified in its entirety by reference to the full text of Amendment No. 1 to Collaboration, Development and License Agreement, a copy of which is
attached hereto as Exhibit 10.1.
Item 9.01 |
Financial Statements and Exhibits. |
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Exhibit |
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Description |
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10.1 |
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Amendment No. 1 to Collaboration, Development and License Agreement, dated as of August 11, 2015, between ZP Opco, Inc. and Eli Lilly and Company |
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SIGNATURE
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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ZOSANO PHARMA CORPORATION |
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Dated: August 17, 2015 |
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By: |
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/s/ Vikram Lamba |
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Name: Vikram Lamba |
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Title: President and Chief Executive Officer |
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EXHIBIT INDEX
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Exhibit |
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Description |
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10.1 |
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Amendment No. 1 to Collaboration, Development and License Agreement, dated as of August 11, 2015, between ZP Opco, Inc. and Eli Lilly and Company |
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Exhibit 10.1
AMENDMENT NO. 1
TO
COLLABORATION, DEVELOPMENT AND LICENSE AGREEMENT
THIS AMENDMENT NO. 1 TO COLLABORATION, DEVELOPMENT AND LICENSE AGREEMENT (this Amendment) is made and entered into as of
August 11, 2015, by and between ZP Opco, Inc., a Delaware corporation (Zosano), and Eli Lilly and Company (Lilly). Capitalized terms used but not otherwise defined herein shall have the meanings given to
such terms in the Collaboration Agreement (as defined below).
WHEREAS, Zosano and Lilly are parties to that certain Collaboration,
Development and License Agreement, dated as of November 21, 2014, by and between Zosano and Lilly (the Collaboration Agreement);
WHEREAS, Zosano and Lilly desire to amend certain provisions of the Collaboration Agreement relating to Critical Success Factor 3 and
governance/oversight of the Manufacture of commercial supplies of the Daily Product, as set forth herein; and
WHEREAS, Section 16.5
of the Collaboration Agreement provides that the Collaboration Agreement may only be modified or amended in writing signed by Zosano and Lilly.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1. Amendment of
Collaboration Agreement. The Collaboration Agreement is hereby amended as follows:
1.1. The first sentence of part 1 (Process
Development) of CSF 3 (CMC/Manufacturing), as set forth in Schedule 3.3.1 attached to the Collaboration Agreement, is deleted in its entirety and replaced with the following:
Parties to agree upon process development plan within eight (8) months after the Effective Date.
1.2. The first sentence of subpart a.iv (Key Performance Indicators) of part 1 (Process Development) of CSF 3 (CMC/Manufacturing), as set
forth in Schedule 3.3.1 attached to the Collaboration Agreement, is deleted in its entirety and replaced with the following:
Parties
to agree upon Device Development Plan within eight (8) months after the Effective Date.
1.3. The first sentence of part 4
(Commercial Supply Chain) of CSF 3 (CMC/Manufacturing), as set forth in Schedule 3.3.1 attached to the Collaboration Agreement, is deleted in its entirety and replaced with the following:
Establishment and oversight by Zosano of an approved commercial supply chain capable of supplying annual market demands of Daily Product,
inclusive of applicator and packaging, for the first three years, post-launch (as agreed upon by the Parties no later than eight (8) months after the Effective Date) and cost of product targets.
1.4. The second and third sentences of Section 6 (Manufacturing) of the Collaboration
Agreement are deleted in their entirety and replaced with the following:
Prior to the transfer of the Regulatory Approval from
Zosano to Lilly, Zosano shall, at Zosanos cost and expense, be responsible for and shall have the final decision-making authority (except for the selection of manufacturers which shall require Lillys consent, such consent not to be
unreasonably withheld, conditioned or delayed) for the planning, implementation and control of the Manufacture of the Daily Product in the Field in the Territory. Aside from day to day management of the Manufacturing operations, Zosanos final
decision-making authority shall expire upon the transfer of Regulatory Approval to Lilly pursuant to Section 4.6. However, subsequent to such transfer of Regulatory Approval to Lilly, Zosano and/or its selected contract manufacturer(s) shall
continue to be responsible for supplies of clinical and commercial material. In the event that Zosano or its contract manufacturer(s) are unable, at any time after the transfer of Regulatory Approval from Zosano to Lilly, to meet Lillys
product requirements for the Daily Product in accordance with the Supply Agreement and the Quality Agreement for the Daily Product (to be entered into by the Parties as set forth below in this Section 6), then Lilly shall have the right to
require Zosano to modify the supply chain for the Daily Product and Zosano shall provide reasonable assistance in connection therewith.
1.5. The sixth and seventh (i.e., the last two) sentences of Section 6.2 of the Collaboration Agreement are deleted in their entirety and
replaced with the following:
Lilly shall have the right (but not the obligation), at any time after the transfer of Regulatory
Approval to Lilly pursuant to Section 4.6, to assume responsibility for the governance/oversight of Zosanos or its contract manufacturer(s) Manufacture of commercial supplies of the Daily Product (any change in contract manufacturer
shall be acceptable to and approved by Lilly, such approval not to be unreasonably withheld, conditioned or delayed). In the event that the Parties transfer to Lilly the responsibility for the governance/oversight of Zosanos or its contract
manufacturer(s) Manufacture of commercial supplies of the Daily Product, Zosano shall provide Reasonable Assistance to Lilly in connection therewith.
2. Scope. This Amendment relates only to the specific matters expressly covered herein. In all other respects, the Collaboration
Agreement shall remain in full force and effect in accordance with its terms.
3. Titles and Subtitles. The titles and subtitles
used in this Amendment are used for convenience only and are not to be considered in construing or interpreting this Amendment or the Collaboration Agreement.
4. Counterparts. This Amendment may be executed in two counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, e-mail (including pdf) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be
valid and effective for all purposes.
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5. Governing Law. This Amendment shall be governed in all respects by the laws of the
State of New York without regard to its choice of law provisions.
[signature page follows]
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IN WITNESS WHEREOF, the undersigned have executed this Amendment No. 1 to Collaboration,
Development and License Agreement as of the date first written above.
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ZP OPCO, INC. |
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By: |
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/s/ Vikram Lamba |
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Name: Vikram Lamba |
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Title: President and CEO |
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ELI LILLY AND COMPANY |
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By: |
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/s/ David A. Ricks |
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Name: David A. Ricks |
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Title: Senior V.P. and President Lilly Bio-Medicines |
Zosano Pharma (NASDAQ:ZSAN)
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