SECOND AMENDMENT TO AMENDED AND RESTATED CAPITAL EXPENDITURE AND EQUIPMENT AGREEMENT
Exhibit 10.4
SECOND AMENDMENT TO AMENDED AND RESTATED CAPITAL
EXPENDITURE AND EQUIPMENT AGREEMENT
THIS SECOND AMENDMENT TO THE AMENDED AND RESTATED CAPITAL EXPENDITURE AND EQUIPMENT AGREEMENT (this “Amendment”) is effective as of January 30, 2014 (the “Amendment Effective Date”) between
ACELRX PHARMACEUTICALS, INC.,
a corporation existing under the laws of the State of Delaware, located at 575 Chesapeake Drive, Redwood City, California 94063 (“AcelRx”)
-and-
PATHEON PHARMACEUTICALS INC.,
a corporation existing under the laws of the State of Delaware, located at 2110 East Galbraith Road, Cincinnati, Ohio ###-###-#### (“Patheon”).
BACKGROUND
AcelRx and Patheon entered into an Amended and Restated Capital Expenditure and Equipment Agreement dated December 11, 2012 as amended July 26, 2013 (the “Agreement”). The purpose of this Amendment is to revise the Agreement to include additional capital for Phase III manufacturing Facility Modifications.
AGREEMENT
NOW, THEREFORE, in consideration of the rights conferred and the obligations assumed herein, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the parties hereby agree as follows:
| 1. | Amendment |
| (a) | In Section 3(b), Expenditures and Payment, and Section 4(a), Patheon Use of Facility Modifications and Dedicated Equipment, the reference to “$3,669,404 is deleted and is replaced with “$4,382,912.” |
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| (b) | Schedule B of the Agreement is deleted in its entirety and is replaced with the attached “REVISED SCHEDULE B.” |
| (c) | The “Background” section of this document is expressly incorporated into this Amendment. |
| 2. | General |
All other terms and conditions of the Agreement shall continue unchanged and remain in full force and effect.
IN WITNESS WHEREOF the duly authorized representatives of the parties have executed this Agreement.
| ACELRX PHARMACEUTICALS, INC. | PATHEON PHARMACEUTICALS INC. | |||||||
| By: | /s/ James Welch | By: | /s/ Francis P. McCune | |||||
| Name: | James Welch | Name: | Francis P. McCune | |||||
| Title: | CFO | Title: | Secretary | |||||
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Revised Schedule B
| Facility Modifications | ||||
| Phase I | ||||
| Renovated space for process room and corridor with white zone finishes, Cat3B gowning, material airlock, CII Security | $ | 434,202 | ||
| Utility modifications: existing unit HVAC once thru air, THP monitoring, Compressed air piping, piped Chilled water, piped Purified water, piped city water, Portable Cat3b central vacuum, portable CAT3b dust collection, Misting shower, 230V and 110V power, bottled nitrogen | $ | 390,068 | ||
| Engineering Cost. This cost will be charged on a time and materials basis, and is estimated to be equal to 12% of the total cost of the first two line items in this table. | $ | 98,912 | ||
| Facility Qualification Cost. This cost will be charged on a time and materials basis, and is estimated to be equal to 5% of the total cost for the first two line items in this table. | $ | 41,214 | ||
| Contingency. This cost covers charges for items that have not yet been determined, and is estimated to be equal to 15% of the total cost for the first two line items in this table. | $ | 123,641 | ||
| Cartridge filling line Facility Support | $ | 10,500 | ||
| Total Phase I | $ | 1,098,537 | ||
| Phase II—Bldg. 6 Packaging/Processing Suites | ||||
| Renovated space for 2 additional processing rooms, all with white zone finishes, material airlock modifications, CII security. (Direct cost $480,437) | ||||
| Utility modifications: new HVAC unit with once thru air sized for Phase 2 and 3, additional THP monitoring, compressed air piping, piped Purified water, piped city water, new CAT3b central vacuum,new Cat3b dust collection, 230 V and 110 V power, piped nitrogen.waster water collection system. (Direct cost $1,467,190) | $ | 1,947,627 | ||
| Contingency (15% of direct costs ($292,144)) | $ | 292,144 | ||
| Engineering Cost (12%) | $ | 233,715 | ||
| Qualification Cost (5%) | $ | 97,381 | ||
| Total Phase II | $ | 2,570,867 | ||
| Phase III—Bldg. 6 Processing Suite and associated support areas | ||||
| Processing room, equipment storage and wash-up area, gowning and material airlocks, CII security and access corridor. | $ | 225,335 | ||
| Utility modifications, including HVAC, facility and process piping, electrical service and THP & controls. | $ | 315,505 | ||
| Engineering Cost (12%) | $ | 64,500 | ||
| Qualification Cost (5%) | $ | 27,042 | ||
| Contingency (15%) | $ | 81,126 | ||
| Total Phase III | $ | 713,508 | ||
| Total Facility Modifications | $ | 4,382,912 |
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