AMENDMENT #5 TO AMENDED AND RESTATED DEVELOPMENT, LICENSE AND SUPPLYAGREEMENT

Exhibit 10.12

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “***”. A COMPLETE VERSION OF THE EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT OF 1933.

AMENDMENT #5

TO AMENDED AND RESTATED DEVELOPMENT,

LICENSE AND SUPPLY AGREEMENT

This Amendment # 5 effective as of the last date on the signature page hereof (“Amendment Effective Date”), by and between CIMA LABS INC., a Delaware corporation (“CIMA”), and Azur Pharma Limited, an Irish limited company (“AZUR”), as assignee of, and successor in title of the rights and obligations of, Azur Pharma International III Limited, a Bermuda corporation, amends and supplements that certain Amended and Restated Development, License and Supply Agreement between CIMA and AZUR dated August 22, 2005, as amended by that Amendment #1 to Amended And Restated Development, License and Supply Agreement effective October 19, 2005, Amendment #2 to Amended and Restated Development, License and Supply Agreement effective April 10, 2007, Amendment #3 to Amended and Restated Development, License and Supply Agreement effective as of January 1, 2008, and Amendment #4 to Amended and Restated Development, License and Supply Agreement effective as of April 15, 2008 (collectively, the “Agreement”).

WHEREAS, Azur would like CIMA to conduct development work to determine whether the granule intermediates prepared in the production process can be held for six-months before finished Product is manufactured;

WHEREAS, the parties wish to add the pricing for certain cartoned presentations of the 6-count blisters to the Agreement; and

WHEREAS, the parties wish to add provision regarding reimbursement for API if CIMA does not meet an annual API usage ratio;

NOW, THEREFORE, the parties hereby agree to amend the Agreement as follows:

“5.10 After manufacture of sixteen commercial batches of Product formulated in the DuraSolv ® technology commencing in calendar year 2007, CIMA and AZUR shall agree upon a consumption rate of API per batch for commercial batches of Product (“API Ratio”). On an annual basis, CIMA shall calculate the amount of API used per batch over such calendar year (commencing with usage in calendar year 2008). If CIMA used

API in excess of the API Ratio, CIMA shall reimburse AZUR based on an API price equal to (i) the lesser of (X) AZUR’s actual replacement cost (excluding intercompany transfer pricing adjustments); or (Y) *** per kg, multiplied by (ii) the difference between the quantity actually used over the calendar year and the quantity forecast to be used over the same period using the API Ratio. Any defective batches and the amount of API used in such defective batches shall be included in the annual calculation for the calendar year in which the batch was made. CIMA shall bear no liability for API other than pursuant to this Section 5.10.”

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed in two originals by their duly authorized representatives.

Amended and Restated Development, License and Supply Agreement

Schedule B-5

***

***

Development Activities, Duration and Costs Summary

***

***

***

***

***

***

Amended and Restated Development, License and Supply Agreement

Schedule F

Cost of Goods

Pursuant to Sections 5.1, 5.3 and 5.6, Alamo shall pay to CIMA for Product the amounts indicated on the following schedule in respect of CIMA’ s manufacturing obligations hereunder.

TRADE and SAMPLES (cost per tablet)

PLACEBOS (cost per tablet)