AGRMT RE OP SAMPLE PROGRAM FORM FOR ARISTADA WITH ALKERMES PHARMACEUTICALS INC.PDF
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DRAFT FOR DISCUSSION PURPOSES ONLY Alkermes, Inc. Correctional Facility Sampling Program Maricopa County Jails, Maricopa County, AZ Alkermes will make available samples of ARISTADA® (aripiprazole lauroxil), free of charge, to the Maricopa County Jails, Maricopa County, AZ for use in its comprehensive re-entry program to the extent such re-entry program includes the following components: • The treatment of medically appropriate adults, ages 18 and older, with a diagnosis of schizophrenia. • The medication is provided as a voluntary component of the re-entry program. • Education is provided to healthcare providers participating in the program with respect to appropriate use of the medication • Education is provided to patients participating in the program with respect to the risks and benefits of the medication. • A continuity of care plan is developed for post-release services. • Patients/clients participate in pre-and post-release programming. • Program assessments are conducted in order to evaluate the program's overall effectiveness. • Limited to two doses of ARLSTADA per patient participant in such re-entry program. • Maricopa County Jails, Maricopa County, AZ and the healthcare provider requesting and receiving the ARISTADA samples, and any other person using the AR1STADA samples, agrees not to sell, resell, trade, barter, return for credit or seek third-party reimbursement for such samples. • ARISTADA will be handled and stored in accordance with the package labeling for the product. • Alkermes, in its sole discretion, may discontinue or alter this program at any time. Alkermes will provide reasonable advance notice in the event of any such alteration or discontinuation. Logistics: • The ARISTADA samples may only be used as part of the Maricopa County Jails, Maricopa County, AZ comprehensive re-entry program provided such program satisfies the above criteria. • For each sample ordered under this program, a signed Certification and Request Form, a copy of which is set forth in Exhibit A, must be faxed or emailed to Alkermes using the cover page set forth as Exhibit B. • Upon receipt of these documents in a form satisfactory to Alkermes, Alkermes will ship sample(s) of ARISTADA to the licensed pharmacy or healthcare provider listed in the Certification and Request Form. Please allow 3 to 5 business days for delivery of product. • The licensed pharmacy or healthcare provider (or his or her designee) must sign and return an Acknowledgement of Content form to acknowledge receipt of the requested sample shipment. Please See Accompanying Full Prescribing Information and Medication Guide Including Boxed Warning DRAFT FOR DISCUSSION PURPOSES ONLY EXHIBIT A Certification and Request for ARISTADA Samples Maricopa County Jails, Maricopa County, AZ Certification By signing this Certification and Request for ARISTADA® (aripiprazole lauroxil) samples, the Maricopa County Jails, Maricopa County, AZ hereby certifies that it is conducting a comprehensive re-entry program that includes the following components: • The treatment of medically appropriate adults, ages 18 and older, with a diagnosis of schizophrenia; • The medication is provided as a voluntary component of the re-entry program; • Education is provided with respect to the risks and benefits of the medication; • A continuity of care plan is developed for post-release services; • Patients/clients participate in pre-and post-release programming; • Program assessments are conducted in order to evaluate the program's overall effectiveness; • Limited to two doses of ARISTADA per patient participating in such re-entry program, and • ARISTADA will be handled and stored in accordance with the package labeling for the product. Maricopa County Jails, Maricopa County, AZ and the licensed healthcare providers requesting and receiving ARISTADA samples (listed below) certify that (i) the samples of ARISTADA (manufactured by Allcermes) received under the terms of this program are for the medical needs of patients; (ii) they will not sell, resell, trade, barter, return for credit or seek third party reimbursement for the samples of ARISTADA received under this program; (iii) the healthcare provider listed below is validly licensed and eligible to request and receive product samples hereunder; (iv) the pharmacy designated below is validly licensed and eligible to receive product samples hereunder; and (v) all product samples requested herein will be used in the Maricopa County Jails, Maricopa County, AZ comprehensive re-entry program described above. Alkermes, in its sole discretion, may discontinue or alter this program at anytime. There is no obligation to continue the use of ARISTADA for any person who receives an ARISTADA sample through this program. Request for Product A new Certification and Request for ARISTADA sample form must be completed for each request for samples. The licensed healthcare provider listed below hereby requests the following quantity* and strengths of ARISTADA under the terms of this program, and requests that such samples be sent to the "shipping address" below. Quantity Strength NDC # 441 mg. 65757-0401-03 662 mg. 65757-0402-03 882 mg. 65757-0403-03 1064 mg. 65757-0404-03 Please See Accompanying Full Prescribing Information and Medication Guide Including Boxed Warning IN WITNESS WHEREOF, the Maricopa County Jails, Maricopa County, AZ and the licensed healthcare provider have each executed and delivered this Certification by its duly authorized representative as of the date listed below. BY Maricona County Jails, Maricopa County, AZ: Name of Authorized Representative: Title: Signature: Date: LICENSED HEALTHCARE PROVIDER REQUESTING SAMPLES: (Print Full Name) Address: State License Number: Professional Designation: Provider's Signature: Date: Shipping Address* * Name: Attention: Phone: Address: City: State: Zip: Subject to quantity limitations of program (to be determined) ** Samples may only be shipped to the requesting healthcare provider or correctional facility pharmacy. DRAFT FOR DISCUSSION PURPOSES ONLY EXHIBIT B Request for Shipment of ARISTADA From: Maricopa County Jails, Maricopa County, AZ To: Alkermes, Inc. Delivery Method: Fax to (609)222-6290 or Email to AlkerruesSlariiHibbertgroup.com In Re: Alkermes, Inc. Correctional Facility Sampling Program Maricopa County Jails, Maricopa County, AZ Attention: Alkermes Sample Program Manager The Maricopa County Jails, Maricopa County, AZ and the licensed healthcare provider identified on the attached Certification and Request for Product (the "Certification Form") hereby request shipment of samples of ARISTADA in the amount, and to the address, listed on the attached Certification Form. Upon receipt of this document and the attached Certification Form, please proceed to ship product to the shipping address specified thereon. Attachment: Certification Form Please See Accompanying Full Prescribing Information and Medication Guide Including Boxed Warning