Memorandum of Understanding –Anti-Viral Supply Program Memorandum of Understanding among the Department of General Services (DGS); the California Department of Public Health (CDPH); and [insert department name] (LHD). This Memorandum of Understanding regarding the federal Department of Health and Human Services (HHS) Anti-Viral Supply Program (Public Law 109-148) is by and among DGS, CDPH, and [insert department name] (LHD). I.

TERM This Memorandum of Understanding will be effective upon the date that all of the parties have executed this memorandum and will expire on either September 1, 2009 or two (2) years after termination date of Federal Health and Human Services (HHS) contracts HHS0100200600015I and HHS0100200600016I, whichever is later. This memorandum may be cancelled by any party upon 30 days’ written notice to the other parties.

II.

SCOPE On behalf of the State of California, DGS utilizes the following contracts for pandemic influenza bulk pharmaceutical purchases: a. State Contracts i. DGS contract #1-08-65-60 and all modifications with Roche Laboratories Inc. for Tamiflu® bulk purchase and ii. DGS contract #1-08-65-61 and all amendments with GlaxoSmithKline for Relenza® bulk purchase. b. Federal Contracts i. HHS contract #HHS0100200600015I and all modifications with Roche Laboratories for Tamiflu® bulk purchase and ii. HHS contract #HHS0100200600016I and all amendments with GlaxoSmithKline for Relenza® bulk purchase The federal contracts listed in Paragraph II.b. allow HHS and states, including the State of California, to purchase discounted pharmaceuticals from manufacturers, Roche Laboratories and GlaxoSmithKline, for the purpose of responding to an influenza pandemic. The state contracts listed in Paragraph II.a., made in accordance with the federal contracts, allow DGS, on behalf of the State of California, to make purchases under the federal contracts.

III.

PURPOSE The purpose of this Memorandum of Understanding is to allow LHD to make purchases through DGS in accordance with the state and federal contracts listed in Paragraph II. Further, this memorandum shall provide an understanding of the contracting process, the responsibilities of the participants, the operating policies of HHS, DGS, CDPH, and the contractual obligations of the state and federal contracts listed in Paragraph II.

IV.

MISSION AND GOALS a. Mission Statement: The mission of the State of California is to provide expedited and improved pandemic influenza response and value through voluntary cooperative purchasing of pandemic influenza bulk pharmaceuticals products under the state and federal contracts listed in Paragraph II.

Rev 11/21/2008

Page 1 of 8

Memorandum of Understanding –Anti-Viral Supply Program

b. Goals i. Maximize cost savings and reduce administrative costs ii. Track and manage pandemic influenza pharmaceutical supply so as to enable an expedited pandemic influenza response iii. Ensure quality distribution of pharmaceuticals and allied products to LHD. V.

AUTHORIZATION By executing this memorandum, LHD is certifying that it is authorized to enter into this memorandum pursuant to applicable laws, rules and regulations. The designated individual executing this agreement certifies that he or she has the authority to represent LHD, is authorized to commit LHD on matters related to the business of pandemic influenza response, and is authorized to participate in the pandemic influenza supply program by Section 10298 of the Public Contract Code, which enables local agencies to participate in state contracts. Participation in the pandemic influenza supply program is limited to local agencies with statutory authority to purchase commodities from state contracts.

VI.

ORGANIZATION AND OPERATION a. LHD is responsible to ensure its representatives are authorized by applicable law to participate in pandemic supply program procurement activities. b. Organization In accordance with the state and federal contracts listed in Paragraph II, DGS has designated an Ordering Officer (OO), responsible for placing purchase orders, and CDPH has designated an Entity Authorizing Officer (EAO), responsible for authorizing purchase orders. Contact information is listed on page 9, entitled “Key Contacts”. c.

Fees for Product Upon receipt of invoice from vendor, CDPH will forward the vendor invoice to the LHD. LHD will send payment, payable to the vendor, to CDPH for processing within 5 days of receipt of the invoice. PAYMENT MUST BE MADE PAYABLE TO THE VENDOR. Any late fees assessed because of delayed payments by the LHD will be billed back to the LHD by CDPH.

d. Administrative Fees DGS will bill CDPH an administrative fee for purchase orders requested by LHD under any of the state and federal contracts listed in Paragraph II. CDPH, in turn, will bill LHD for reimbursement of the administrative fee. The administrative fee should NOT be included in the order total, nor remitted before an invoice is received from DGS. (You may click on “DGS Price Book” at the following link for current fees: http://www.ofs.dgs.ca.gov/Price+Book/P/Purchasing.htm

Rev 11/21/2008

Page 2 of 8

Memorandum of Understanding –Anti-Viral Supply Program

e. Shipping Fees LHD shall reimburse CDPH for shipping charges. CDPH will bill LHD for shipping charges. Shipping charges will be invoiced separately from administrative fees. VII.

RESPONSIBILITIES a. The CDPH Entity Authorizing Official, known as the “EAO” shall i. Certify on LHD’s behalf, that each order is to be applied toward that LHD’s Anti-Viral pandemic purchase; ii. Distribute and invoice pandemic influenza procurement supplies placed through this memorandum; iii. Forward memorandum signed by LHD and CDPH to the DGS for signature; iv. Refer LHD to the DGS for order placement; v. Provide DGS with the request for order, billing code, fund information, delivery address and other information as required by DGS for order placement; vi. Maintain and provide copies of appropriate licensure from the State Board of Pharmacy, DEA registration and license as pharmacist; vii. Serve as point of contact “POC” for LHD regarding matters related to pandemic influenza supply planning and management; viii. Ensure that the orders placed for use under the Anti-Viral Supply Program are placed under the authority of the local health officer and meet the requirements of the state and federal contracts listed in Paragraph II. ix. Identify where each of the anti-viral drug treatment courses are stored; x. Comply with the state and federal contracts listed in Paragraph II; xi. Operate within the boundaries established by the Robinson-Patman Price Discrimination Act (15 U.S.C. 13(a)) and “own use” requirements as defined by Abbott labs V. Portland Retail Druggists (425 U.S. 1(1976)) and Jefferson County Pharmaceutical Association, Inc. v. Abbott Labs (460 U.S. 150 (1983)); xii. Update DGS regarding changes of CDPH information listed in “Key Contacts” on page 9 ; xiii. Comply with DGS Contract Notification and HHS letter of June 29, 2006; xiv. Notify Local Health Departments of the Anti-Viral Supply Program;

Rev 11/21/2008

Page 3 of 8

Memorandum of Understanding –Anti-Viral Supply Program

b. The DGS Ordering Officer, known as the “OO,” shall: i. Serve as the point of contact for CDPH regarding matters related to the orders placed under this memorandum; ii. Place all orders under this memorandum; iii. Process this memorandum; iv. Provide monthly reports to CDPH of the orders placed through this memorandum; v. Maintain this memorandum and placed orders; vi. Comply with the state and federal contracts listed in Paragraph II; vii. Operate within the boundaries established by the Robinson-Patman Price Discrimination Act (15 U.S.C. 13(a)) and “own use” requirements as defined by Abbott labs v. Portland Retail Druggists (425 U.S. 1(1976)) and Jefferson County Pharmaceutical Association, Inc. v. Abbott Labs (460 U.Sl 150 (1983)); viii. Update CDPH and LHD regarding changes to DGS information on “Key Contacts” on page 9. ix. Comply with DGS Contract Notification and HHS letter of June 29, 2006; x. Assist in resolving administrative, contract or supplier problems that cannot be resolved by LHD and/or CDPH; xi. Make available to CDPH and LHD copies of the state and federal contracts listed in Paragraph II; c.

The LHD Authorized Official (AO) shall: i. Certify to CDPH and the DGS that he/she has authority to purchase goods from contracts authorized by DGS; ii. Serve as the point of contact for CDPH and the DGS regarding matters related to the orders placed under this memorandum; iii. Provide the contact information listed on page 9 of this memorandum “Local Agency Contact” and notify DGS and CDPH of any changes; iv. Forward orders to be placed under this memorandum as instructed in “Contract Notification”; v. Maintain and provide a copy of licensure from either the State Board of Pharmacy or license as a health care provider by the CDPH and DEA Registration; vi. Comply with the state and federal contracts listed in Paragraph II; vii. Operate within the boundaries established by the Robinson-Patman Price Discrimination Act (15 U.S.C. 13(a)) and “own use” requirements

Rev 11/21/2008

Page 4 of 8

Memorandum of Understanding –Anti-Viral Supply Program as defined by Abbott labs V. Portland Retail Druggists (425 U.S. 1(1976)) and Jefferson County Pharmaceutical Association, Inc. v. Abbott Labs (460 U.S. 150 (1983)); viii. Update the OO and EAO regarding changes to the “Key Contacts” information listed on page 9. ix. Comply with DGS Contract Notification and HHS letter of June 29, 2006; x. Handle purchased pharmaceutical product in accordance with standard pharmacy protocol and requirements; xi. Review whether shipment integrity has been maintained upon receipt and immediately notify the CDPH EAO if shipment is damaged; xii. Ensure available funding for the purchases requested by LHD; xiii. Submit payment to CDPH for all products purchased with request for order and promptly pay (net 30) CDPH directly for administrative fee and shipping costs. DGS, CDPH, and the State of California do not assume any responsibility to pay for products ordered or purchased by LHD. xiv. Provide access to DGS and/or CDPH for physical and record examination and audit during normal business hours as specified in Paragraph IX.e. xv. Ensure its representatives are authorized by applicable law to participate in pandemic supply program procurement activities. VIII.

AUTHORITY Statutory authorities related to this memorandum include: a. Government Code Section 14977.1 (a) and (b) enabling the DGS to enter into exclusive or nonexclusive contracts on a bid or negotiated basis with manufacturers and suppliers of single source or multi source drugs, and exempting said contracts from Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of the Public Contract Code. b. Public Contract Code Section 10298 enabling DGS to make its services available, upon the terms and conditions agreed to, to any city, county, city and county, district, or other local governmental body or corporation empowered to expend public funds for the acquisition of goods, information technology, or services for assisting the local agency in acquisitions conducted pursuant to Chapter 2 (commencing with Section 10290), Chapter 3 (commencing with Section 12100), and Chapter 3.6 (commencing with Section 12125). c.

Health and Safety Code Section 101185 defining a “local health department” to mean any one of the following public health administrative organizations: i. A local health department serving one or more counties that shall provide services to all cities whose population is less than 50,000 in addition to the unincorporated territory of the county or counties

Rev 11/21/2008

Page 5 of 8

Memorandum of Understanding –Anti-Viral Supply Program ii. A county health department that does not serve all of the cities of less than 50,000 population, but that has the provisional approval of the department, in accordance with Section 101225. iii. The health department of a city of 50,000 or greater population, except that the governing body of the city by resolution may declare its intention to be included under the jurisdiction of the county health department, as provided by existing statutes. iv. The local health department of any county that had under its jurisdiction on September 19, 1947, a population in excess of 1,000,000 or the local health department of any city and county. IX.

GENERAL PROVISIONS a. Liability LHD is responsible to ensure its representatives are authorized by applicable law to participate in pandemic influenza supply program procurement activities. LHD is responsible for the acts or omissions to act of its officers, agents and employees and the results thereof. Neither DGS nor CDPH shall assume any responsibility for the accountability of funds expended by LHD or the issuance or non-issuance of a purchase order by LHD. LHD shall be solely accountable for its own expenditures of public funds made hereunder. Neither DGS nor CDPH shall incur financial responsibility in connection with orders or purchases made by LHD under this memorandum. b. Cancellation This Memorandum may be terminated with or without cause by the DGS, CDPH, or the LHD upon 30 days written notice to the other parties. Cancellation terminates the authority of LHD to use the procurement supply program contracts listed in Paragraph II. LHD is liable for its outstanding orders at the time of cancellation. c.

Assignment LHD shall not assign, delegate or transfer any rights or obligations under this memorandum without the prior written consent of DGS and CDPH.

d. Amendments Any amendment or modification to this memorandum shall be in writing and shall not be effective until executed by DGS, CDPH, and LHD. e. Examination and Audit DGS, CDPH, and/or their designated representatives shall have the right to review and copy any records and supporting documentation pertaining to product ordered through this memorandum. LHD agrees to maintain such records for possible audit for a minimum of three (3) years after final payment. LHD agrees to allow the auditor(s) access to such records during normal business hours and to allow interviews of any employees or others who might reasonably have Rev 11/21/2008

Page 6 of 8

Memorandum of Understanding –Anti-Viral Supply Program information related to such records. Further, LHD agrees to include a similar right of DGS and CDPH to audit records and interview staff in any subcontract related to performance of this memorandum. CDPH or its designated representative shall have the right to perform physical audits of the product the premises and conditions under which Anti-Viral supplies are kept by LHD. f.

Applicable Law This memorandum, and executed amendments thereto, shall be governed by and shall be interpreted in accordance with the laws of the State of California; venue of any action brought with regard to this memorandum shall be in Sacramento County, Sacramento, California.

g. Complete Agreement This memorandum contains all negotiations and agreements between DGS, CDPH, and LHD. No other understanding regarding this memorandum, whether written or oral, may be used to bind the other parties. h. Severability DGS, CDPH, and LHD agree that if any provision of this Memorandum is found to be illegal or unenforceable, such term or provision shall be deemed stricken and the remainder of the memorandum shall remain in full force and effect. Any party having knowledge of such term or provision shall promptly inform the other parties of the presumed non-applicability of such provision. i.

Waiver If DGS and/or CDPH fail(s) to enforce any provision of this Memorandum, that failure does not waiver the provision or their right to enforce it.

In witness whereof, the undersigned parties have signed this memorandum of understanding intending to be bound by it. DGS on behalf of the Pandemic Supply Program By: Title: Date:

CDPH on behalf of the Entity Authorizing Official (EAO) By: Title: Date:

Participating Agency (Person with legal authority to bind the agency) By: Title: Date: LHD Agency Name:

Rev 11/21/2008

Page 7 of 8

Memorandum of Understanding –Anti-Viral Supply Program KEY CONTACTS Each party will send the other parties an updated Key Contact Sheet within 30 days of changes. CDPH Entity Authorizing Official (EAO) Address:

Telephone Facsimile: E-mail:

Tom Ahrens, Pharm.D. UPS and Federal Express: CDPH Emergency Preparedness Office 1615 Capitol Ave Suite 73-373 Sacramento, CA 95814 U.S. Mail Address: CDPH Emergency Preparedness Office P.O. Box 997377 MS 7002 Sacramento, CA 95899-7377 (916) 650-6438 9916) 650-6420 [email protected]

DGS State Ordering Officer (OO) Address:

Telephone: Facsimile: E-mail

Christina Nunez DGS 707 Third Street, 2nd Floor, West Sacramento, CA 95605

(916) 375-4482 (916) 375-4490 [email protected]

LHD LHD Authorized Official (AO) Mailing Address: Telephone: Facsimile: E-mail: Pharmacy License # (attach copy of license) DEA Registration Number (attach copy of registration) Delivery Address for Pharmaceutical Products:

Rev 11/21/2008

Page 8 of 8